Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Pudong |
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(Address of principal executive offices) |
(Zip Code) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
The Stock Exchange of Hong Kong Limited |
* | Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on the Stock Exchange of Hong Kong Limited. |
☒ | Accelerated Filer | ☐ | ||||
Non-accelerated filer |
☐ | Smaller reporting company | ||||
Emerging growth company |
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• | The uncertainties in the Chinese legal system could materially and adversely affect us; |
• | Changes in United States and China relations, as well as relations with other countries, and/or regulations may adversely impact our business, our operating results, our ability to raise capital and the market price of our ordinary shares and/or our ADSs; |
• | The Chinese government may intervene in or influence our operations at any time, which could result in a material change in our operations and significantly and adversely impact the value of our ADSs and ordinary shares, including potentially making those ADSs or ordinary shares worthless; |
• | The audit report included in this Annual Report on Form 10-K was prepared by an auditor who is not inspected by the U.S. Public Company Accounting Oversight Board, or the PCAOB, and as such, you are deprived of the benefits of such inspection, we may be subject to additional Nasdaq listing criteria or other penalties and our ADSs may be delisted from the U.S. stock market; |
• | Proceedings brought by the SEC against China-based accounting firms could result in our inability to file future financial statements in compliance with the requirements of the Exchange Act; |
• | Compliance with China’s Data Security Law, Cyber Security Law, Cybersecurity Review Measures, Personal Information Protection Law, the Regulation on the Administration of Human Genetic Resources, the Biosecurity Law, and any other future laws and regulations may entail significant |
expenses and could materially affect our business. Our failure to comply with such laws and regulations could lead to government enforcement actions and significant penalties against us, materially and adversely impacting our operating results; |
• | The economic, political and social conditions in mainland China, as well as governmental policies, could affect the business environment and financial markets in mainland China, our ability to operate our business, our liquidity and our access to capital; |
• | If the Chinese government determines that our corporate structure does not comply with Chinese regulations, or if Chinese regulations change or are interpreted differently in the future, the value of our ADSs or ordinary shares may decline in value or become worthless; |
• | The approval of, filing or other procedures with the CSRC or other Chinese regulatory authorities may be required in connection with issuing securities to foreign investors under Chinese law, and, if required, we cannot predict whether we will be able, or how long it will take us, to obtain such approval or complete such filing or other procedures. |
• | We may be exposed to liabilities under the U.S. Foreign Corrupt Practices Act, or FCPA, and Chinese anti-corruption laws, and any determination that we have violated these laws could have a material adverse effect on our business or our reputation; |
• | Restrictions on currency exchange may limit our ability to receive and use financing in foreign currencies effectively; |
• | We may rely on dividends and other distributions on equity paid by our Chinese subsidiaries to fund any cash and financing requirements we may have, and any limitation on the ability of our Chinese subsidiaries to make payments to us could have a material and adverse effect on our ability to conduct our business; |
• | Chinese regulations relating to the establishment of offshore special purpose companies by residents in mainland China may subject our China resident beneficial owners or our wholly foreign-owned subsidiaries in mainland China to liability or penalties, limit our ability to inject capital into these subsidiaries, limit these subsidiaries’ ability to increase their registered capital or distribute profits to us, or may otherwise adversely affect us; |
• | Chinese regulations establish complex procedures for some acquisitions of mainland China based companies by foreign investors, which could make it more difficult for us to pursue growth through acquisitions in mainland China; |
• | Chinese manufacturing facilities have historically experienced issues operating in line with established GMPs and international best practices, and passing FDA, NMPA, and EMA inspections, which may result in a longer and costlier current GMP inspection and approval process by the FDA, NMPA, or EMA for our Chinese manufacturing processes and third-party contract manufacturers; |
• | Our business benefits from certain financial incentives and discretionary policies granted by local governments. Expiration of, or changes to, these incentives or policies would have an adverse effect on our results of operations; |
• | It may be difficult for overseas regulators to conduct investigations or collect evidence within mainland China; |
• | If we are classified as a Chinese resident enterprise for Chinese income tax purposes, such classification could result in unfavorable tax consequences to us and our non-Chinese shareholders or ADS holders; |
• | We and our shareholders face uncertainties in mainland China with respect to indirect transfers of equity interests in Chinese resident enterprises; |
• | Any failure to comply with Chinese regulations regarding the registration requirements for our employee equity incentive plans may subject us to fines and other legal or administrative sanctions, which could adversely affect our business, financial condition and results of operations; |
• | Certain of our investments may be subject to review from the Committee on Foreign Investment in the United States, or CFIUS, which may delay or block a transaction from closing; |
• | Changes in United States and international trade policies and relations, particularly with regard to mainland China, may adversely impact our business and operating results; |
• | It may be difficult to enforce against us or our management in mainland China any judgments obtained from foreign courts; |
• | We may be subject to fines due to the lack of registration of our leases; |
• | Failure to renew our current leases or locate desirable alternatives for our leased properties could materially and adversely affect our business; |
• | We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future. To date, we have not generated sufficient revenue from product sales to cover corresponding expenses, and we may never achieve or sustain profitability; |
• | We are invested in the commercial success of our four approved products and our ability to generate product revenues in the near future is highly dependent on the commercial success of each of those products; |
• | We rely on third parties to conduct our pre-clinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products or product candidates and our business could be substantially harmed; |
• | If we are unable to obtain and maintain patent protection for our products and product candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties may compete directly against us; |
• | If we fail to maintain proper internal financial reporting controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired; and |
• | Other risks and uncertainties, including those listed under “Part I—Item 1A — |
• | received approval for and commercialized four products (ZEJULA, Optune, QINLOCK and NUZYRA); |
• | expanded our pipeline to increase our product candidates under development from four in 2015 to 28 today in oncology, autoimmune disorders, infectious diseases, and neuroscience, including 12 programs in late-stage clinical development; |
• | partnered with established biopharmaceutical and leading healthcare companies such as GlaxoSmithKline (GSK), Novocure, argenx, Turning Point, Deciphera, Karuna, Blueprint, MacroGenics, Cullinan, and Amgen through in-licensing product candidates to position ourselves as a partner of choice for the development and commercialization of novel therapeutics in Greater China; |
• | achieved reimbursement for ZEJULA in mainland China through its inclusion on the National Reimbursement Drug List (NRDL); |
• | built a commercial organization of approximately 945 employees; |
• | increased our research and development team to approximately 788 employees; |
• | assembled a leadership team of seasoned industry veterans with extensive pharmaceutical research, development, and commercialization experience in both global and Chinese biopharmaceutical companies; |
• | advanced our in-house discovery pipeline and capabilities targeting global markets; |
• | built out our facilities in China to support our regulatory, clinical, manufacturing, and commercial infrastructure in eleven locations across Greater China and the United States; |
• | acquired land-use rights for 50,851 square meters of land in Suzhou for the purpose of constructing and operating a manufacturing site and research center; and |
• | expanded our U.S. footprint by opening a research facility in the San Francisco Bay area and a new corporate office in Cambridge, Massachusetts. |
Product |
Indications |
Regulatory Status |
Commercial Rights |
Partner | ||||
|
1 st line ovarian cancer maintenance treatmentPlatinum sensitive relapsed ovarian cancer maintenance treatment |
Launched in mainland China, Hong Kong, and Macau | mainland China, Hong Kong, and Macau | GSK | ||||
|
Newly diagnosed glioblastoma multiforme (GBM) Recurrent GBM |
Launched in mainland China, Hong Kong, and Macau | mainland China, Hong Kong, Macau, and Taiwan | Novocure | ||||
|
4 th line gastrointestinal stromal tumors (GIST) |
Launched in mainland China, Hong Kong, and Taiwan | mainland China, Hong Kong, Macau, and Taiwan | Deciphera | ||||
|
Acute bacterial skin and skin structure infections (ABSSSI) Community-acquired bacterial pneumonia (CABP) |
Launched in mainland China | mainland China, Hong Kong, Macau, and Taiwan | Paratek |
• | Patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK TKIs, with or without prior chemotherapy, and have no satisfactory alternative treatments; and |
• | Patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 TKI. |
• | Patients with ROS1-positive advanced NSCLC who have not been previously treated with a ROS1 TKI; |
• | Patients with ROS1-positive advanced NSCLC who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; |
• | Patients with ROS1-positive advanced NSCLC pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and |
• | Patients with advanced solid tumors who have an NTRK gene fusion and who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. |
• | A Phase I proof-of-concept China-only dose escalation and expansion trial of tebotelimab monotherapy and in combination with brivanib, a compound that we in-licensed from Bristol-Myers Squibb, in patients with advanced hepatocellular carcinoma (HCC). The study was initiated in April 2020. |
• | A Phase I China-only clinical trial of tebotelimab in patients with melanoma. In November 2020, we enrolled the first patient in the study. |
• | A Phase Ib dose escalation and multi-cohort expansion clinical study of tebotelimab in combination with ZEJULA in Greater China, including gastric cancer, triple negative breast cancer, biliary tract cancer, and endometrial carcinoma. We have initiated dosing in all cohorts. |
• | monitoring and supervising the administration of pharmaceutical products, medical devices and equipment as well as cosmetics in mainland China; |
• | formulating administrative rules and policies concerning the supervision and administration of the pharmaceutical, medical device and cosmetics industry; |
• | evaluating, registering and approving chemical drugs, biological products and traditional Chinese medicine, or the TCM; |
• | approving and issuing permits for the manufacture and export/import of pharmaceutical products; and |
• | examining and evaluating the safety of pharmaceutical products, medical devices and cosmetics and handling significant accidents involving these products. |
• | The applicant shall first conduct an overall evaluation on the global clinical trial data and further make trend analysis of the Asian and Chinese clinical trial data. In the analysis of Chinese clinical trial data, the applicant shall consider the representativeness of the research subjects, i.e., the participating patients; |
• | The applicant shall analyze whether the amount of Chinese research subjects is sufficient to assess and adjudicate the safety and effectiveness of the study drug, and satisfy the statistical and relevant legal requirements; and |
• | The onshore and offshore IMCCT research centers shall be subject to on-site inspections by the Chinese regulatory authorities. |
• | The IMCCT drug does not need to be approved or entered into either a Phase II or III clinical trial in a foreign country, except for preventive biological products. Phase I IMCCT is permissible in mainland China. |
• | The application for drug marketing authorization can be submitted directly after the completion of the IMCCT. |
• | With respect to clinical trial and market authorization applications for imported innovative chemical drugs and therapeutic biological products, the marketing authorization in the country or region where the foreign drug manufacturer is located will not be required. |
• | the effective constituent of drug extracted from plants, animals, minerals, etc. as well as the preparations thereof have never been marketed in mainland China, and the material medicines and the preparations thereof are newly discovered; |
• | the chemical raw material medicines as well as the preparations thereof and the biological product have not been approved for marketing home and abroad; |
• | the new drugs are for treating AIDS, malignant tumors and rare diseases, etc., and have obvious advantages in clinical treatment; or |
• | the new drugs are for treating diseases with no effective methods of treatment. |
• | The drug candidate must be an innovative new drug or improved new drug; |
• | The drug candidate must be used for the prevention and treatment of life-threatening illnesses or illnesses which have a serious impact on the quality of life; and |
• | There is no other effective prevention or treatment method, or there is adequate evidence proving that the drug candidate has obvious clinical advantages over existing treatment methods. |
• | The drug candidate is for treatment of life-threatening illnesses with no effective treatment method or in dire need in case of a public health emergency; and clinical trial data on drug efficacy is available and the clinical value of the drug candidate can be predicated based on such data; or |
• | For vaccines urgently needed in major public health crisis or other vaccines that are deemed by the NHC to be urgently needed, they may receive conditional approvals if their assessed benefits outweigh the risks. |
• | Drugs that are in short supply and urgently needed clinically, or innovative new drugs or improved new drugs for the prevention and treatment of major contagious diseases or rare diseases; |
• | Drugs for pediatric use with new product specification, dosage form and strength that comply with pediatric physiological characteristics; |
• | Vaccines and innovative vaccines urgently needed for the prevention and control of diseases; |
• | Drugs that received break-through therapeutic drug designation; |
• | Drugs that are qualified for conditional approval; and |
• | Others qualified for priority review as stipulated by the NMPA. |
• | laboratory animals must be qualified and sourced from institutions that have Certificates for Production of Laboratory Animals; |
• | the environment and facilities for the animals’ living and propagating must meet state requirements; |
• | the animals’ feed must meet state requirements; |
• | the animals’ feeding and experimentation must be conducted by professionals, specialized and skilled workers, or other trained personnel; |
• | the management systems must be effective and efficient; and |
• | the applicable entity must follow other requirements as stipulated by Chinese laws and regulations. |
• | drugs with new drug certificates only; or |
• | drugs with new drug certificates and drug approval numbers. |
• | the transferor holds new drug certificates or both new drug certificates and drug approval numbers, and the monitoring period has expired or there is no monitoring period; or |
• | with respect to drugs without new drug certificates, both the transferor and the transferee are legally qualified drug manufacturing enterprises, one of which holds over 50% of the equity interests in the other, or both of which are majority-owned subsidiaries of the same drug manufacturing enterprise. |
• | completion of extensive pre-clinical studies, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies all performed in compliance with applicable regulations, including the FDA’s GLP regulations; |
• | submission to the FDA of an IND which must become effective before human clinical trials may begin and must be updated annually; |
• | approval by an independent institutional review board (IRB) representing each clinical site before each clinical trial may be initiated; |
• | performance of adequate and well-controlled human clinical trials in accordance with applicable good clinical practices, or GCPs and other clinical trial-related regulations, to establish the safety and efficacy of the proposed drug or biological product for its proposed indication; |
• | preparation and submission to the FDA of an NDA or BLA; |
• | a determination by the FDA within sixty (60) days of its receipt of an NDA or BLA to accept the application for filing referral to the NDA or BLA to an FDA advisory committee, if FDA determines it to be appropriate; |
• | satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the API and finished drug or biological product are produced to assess compliance with the FDA’s current Good Manufacturing Practices, or cGMP; |
• | potential FDA audit of the pre-clinical and/or clinical trial sites that generated the data in support of the NDA or BLA; and |
• | payment of user fees and FDA review and approval of the NDA or BLA prior to any commercial marketing or sale of the drug or biologic in the United States. |
• | Phase I: The product candidate is initially introduced into a small number of healthy volunteers who are initially exposed to a single dose and then multiple doses. The primary purpose of these clinical trials is to assess the metabolism, pharmacologic action, side effect tolerability and safety of the product candidate. |
• | Phase II: The product candidate is administered to a limited patient population to determine dose tolerance and optimal dosage required to produce the desired benefits. At the same time, safety and further pharmacokinetic and pharmacodynamic information is collected, as well as identification of possible adverse effects and safety risks and preliminary evaluation of efficacy. |
• | Phase III: The product candidate is administered to an expanded number of patients, generally at multiple sites that are geographically dispersed, in well-controlled clinical trials to generate enough data to demonstrate the efficacy of the product candidate for its intended use, its safety profile and to establish the overall benefit/risk profile of the product candidate and provide an adequate basis for approval and labeling. Phase III clinical trials may include comparisons with placebo and/or other comparator treatments. |
• | Post-approval trials, sometimes referred to as Phase IV clinical trials, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, FDA may mandate the performance of Phase IV clinical trials. |
• | the U.S. Foreign Corrupt Practices Act (FCPA), which prohibits U.S. companies and their representatives from paying, offering to pay, promising to pay or authorizing the payment of anything of value to any foreign government official, government staff member, political party or political candidate for the purpose of obtaining or retaining business or to otherwise obtain favorable treatment or influence a person working in an official capacity. In many countries, the health care professionals we regularly interact with may meet the FCPA’s definition of a foreign government official. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls; |
• | federal healthcare program anti-kickback laws, which prohibit, among other things, persons from knowingly and willfully offering, soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid; |
• | federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, information or claims for payment from Medicare, Medicaid or other third-party payers that are false or fraudulent; |
• | the federal Health Insurance Portability and Accountability Act of 1996, as amended, which prohibits executing a scheme to defraud any healthcare benefit program (including private health plans) or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; |
• | federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs; |
• | the so-called “federal sunshine” law, which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with physicians, certain non-physician practitioners and teaching hospitals to the federal government for re-disclosure to the public; and |
• | state law equivalents of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including private insurers, state transparency laws, state laws limiting interactions between pharmaceutical manufacturers and members of the healthcare industry, state laws regulating or requiring the reporting of prices, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts. |
• | Any person who uses, promises to sell, sells or imports any patented product or product directly obtained in accordance with the patented methods after such product is sold by the patent owner or by its licensed entity or individual; |
• | Any person who has manufactured an identical product, has used an identical method or has made necessary preparations for manufacture or use prior to the date of patent application and continues to manufacture such product or use such method only within the original scope; |
• | Any foreign transportation facility that temporarily passes through the territory, territorial waters or territorial airspace of mainland China and uses the relevant patents in its devices and installations for its own needs in accordance with any agreement concluded between mainland China and that country to which the foreign transportation facility belongs, or any international treaty to which both countries are party, or on the basis of the principle of reciprocity; |
• | Any person who uses the relevant patents solely for the purposes of scientific research and experimentation; or |
• | Any person who manufactures, uses or imports patented drug or patented medical equipment for the purpose of providing information required for administrative approval, or manufactures, uses or imports patented drugs or patented medical equipment for the abovementioned person. |
By Function |
Number of employees |
|||
Research and Development |
788 | |||
Commercial |
945 | |||
Manufacturing |
81 | |||
General and Administrative* |
137 | |||
Total |
1,951 |
* | Includes finance, legal, human resources, information technology and other general and administrative functions. |
• | Our Board is responsible for establishing our risk management and internal control system and reviewing its effectiveness. |
• | Our Audit Committee oversees and manages the overall risks associated with our business operations, including (i) developing, reviewing, and approving our risk management programs and procedures to ensure that it is consistent with our corporate objectives; (ii) monitoring the most significant risks associated with our business operation and our management’s handling of such risks; (iii) reviewing our corporate risk matrix in the light of our corporate risk tolerance; (iv) reviewing the significant residual risks and the need to set up mitigating controls; and (v) monitoring and ensuring the appropriate application of our risk management framework across the company. |
• | Our Chief Legal Officer, Mr. F. Ty Edmondson, is responsible for (i) formulating and updating our risk management program and target; (ii) reviewing and approving major risk management issues of the Company; (iii) promulgating risk management measures; (iv) providing guidance on our risk management approach to the relevant departments in the Company; (v) reviewing the relevant departments’ reporting on key risks and providing feedbacks; (vi) supervising the implementation of our risk management measures by the relevant departments; (vii) ensuring that the appropriate structure, processes and competencies are in place across the Company; (viii) developing and operating an enterprise risk management program for the Company, the results of which are reported to the Audit Committee throughout the year; (ix) developing and managing the Company’s government affairs efforts; (x) reporting to our Audit Committee on our material risks; and (xi) coordinating and providing updates to the Board of Directors as necessary. |
• | The relevant departments in the Company are responsible for implementing our risk management program under the oversight of our Legal and Compliance Departments. |
• | Our Finance Department is responsible for developing and implementing our internal controls systems. |
• | continue to commercialize, and maintain and expand sales, marketing and commercialization infrastructure for our approved products and any other products for which we may obtain regulatory approval; |
• | maintain and expand regulatory approvals for our products and product candidates that successfully complete clinical trials; |
• | continue our development and commence clinical trials of our product candidates; |
• | acquire or in-license other intellectual property, product candidates and technologies; |
• | maintain and expand our manufacturing facilities; |
• | hire additional clinical, operational, financial, quality control and scientific personnel; |
• | seek to identify additional product candidates; |
• | obtain, maintain, expand and protect our intellectual property portfolio; and |
• | enforce and defend intellectual property-related claims. |
• | the cost and timing of future commercialization activities for ZEJULA, Optune, QINLOCK, NUZYRA and any other product candidates for which we receive regulatory approval; |
• | the pricing of and product revenues received, if any, from future commercial sales of our approved products and any other products for which we receive regulatory approval; |
• | the scope, progress, timing, results and costs of clinical development of our products in additional indications, if any; |
• | the scope, progress, timing, results and costs of researching and developing our product candidates, and conducting pre-clinical and clinical trials; |
• | the cost, timing and outcome of seeking, obtaining, maintaining and expanding regulatory approval of our products and product candidates; |
• | our ability to establish and maintain strategic partnerships, collaboration, licensing or other arrangement and the economic and other terms, timing and success of such arrangements; |
• | the cost, timing and outcome of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property related claims; |
• | the extent to which we acquire or in-license other product candidates and technologies and the economic and other terms, timing and success of such collaboration and licensing arrangements; |
• | cash requirements of any future acquisitions; |
• | the number, characteristics and development requirements of the product candidates we pursue; |
• | resources required to develop and implement policies and processes to promote ongoing compliance with applicable healthcare laws and regulations; |
• | costs required to ensure that our and our partners’ business arrangements with third parties comply with applicable healthcare laws and regulations; |
• | our headcount growth and associated costs; and |
• | the costs of operating as a public company in both the United States and Hong Kong. |
• | maintain commercial manufacturing or supply arrangements with third-party manufacturers for ZEJULA, Optune, QINLOCK, and NUZYRA; |
• | produce, through a validated process or procure, both internally or from third-party manufacturers sufficient quantities and inventory of each of our approved products to meet demand; |
• | build and maintain internal sales, distribution and marketing capabilities sufficient to generate commercial sales of each of our approved products; |
• | secure widespread acceptance of ZEJULA, Optune, QINLOCK, and NUZYRA from physicians, healthcare payors, patients and the medical community; |
• | properly price and obtain coverage and adequate reimbursement of each of our approved products by governmental authorities, private health insurers, managed care organizations and other third-party payors; |
• | maintain compliance with ongoing regulatory labeling, packaging, storage, advertising, promotion, recordkeeping, safety and other post-market requirements; |
• | manage our growth and spending as costs and expenses increase due to commercialization; and |
• | manage business interruptions resulting from the occurrence of any pandemic, epidemic, including from the outbreak of COVID-19, or any other public health crises, natural catastrophe or other disasters. |
• | acceptable evidence of safety and efficacy; |
• | relative convenience and ease of administration; |
• | prevalence and severity of any adverse side effects; |
• | availability of alternative treatments; |
• | pricing, cost effectiveness and value propositions; |
• | effectiveness of our sales and marketing capabilities and strategies; |
• | ability to obtain sufficient third-party coverage and reimbursement; |
• | the clinical indications for which such product are approved, as well as changes in the standard of care for their targeted indications; |
• | the continuing effectiveness of manufacturing and supply chain; |
• | warnings and limitations contained in the approved labeling for such product; |
• | safety concerns with similar products marketed by others; |
• | the prevalence and severity of any side effects as a result of treatment with such product; |
• | our ability to comply with regulatory post-marketing requirements associated with the approval of such product; |
• | the actual market-size for such product, which may be larger or smaller than expected; |
• | competitor’s entry timing and price; and |
• | our ability to manage complications or barriers that inhibit our commercialization team from reaching the appropriate audience to promote our product(s) because of the outbreak of COVID-19 or any other public health crises, natural catastrophe or other disasters. |
• | successful enrollment of patients in, and completion of, clinical trials as well as completion of pre-clinical studies, which may be especially challenging given the COVID-19 pandemic; |
• | receipt of regulatory approvals from applicable regulatory authorities for planned clinical trials, future clinical trials or drug registrations, manufacturing and commercialization; |
• | successful completion of all safety and efficacy studies required to obtain regulatory approval in Greater China, the United States and other jurisdictions for our product candidates; |
• | adapting our commercial manufacturing capabilities to the specifications for our product candidates for clinical supply and commercial manufacturing; |
• | making and maintaining arrangements with third-party manufacturers; |
• | obtaining and maintaining patent, trade secret and other intellectual property protection and/or regulatory exclusivity for our product candidates; |
• | launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; |
• | acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors; |
• | effectively competing with other therapies and alternative drugs; |
• | obtaining and maintaining healthcare coverage and adequate reimbursement; |
• | successfully enforcing and defending intellectual property rights and claims; and |
• | maintaining a continued acceptable safety, tolerability and efficacy profile of the product candidates following regulatory approval. |
• | disagreement with the NMPA, FDA, and EMA or comparable regulatory authorities regarding the number, design, size, conduct or implementation of our clinical trials; |
• | failure to demonstrate to the satisfaction of the NMPA, FDA, and EMA or comparable regulatory authorities that a product candidate is safe and effective for its proposed indication; |
• | failure of CROs, clinical study sites or investigators to comply with the ICH-good clinical practice, or GCP, requirements imposed by the NMPA, FDA, and EMA or comparable regulatory authorities; |
• | failure of the clinical trial results to meet the level of statistical significance required by the NMPA, FDA, and EMA or comparable regulatory authorities for approval; |
• | failure to demonstrate that a product’s or product candidate’s clinical and other benefits outweigh its safety risks; |
• | the NMPA, FDA, and EMA or comparable regulatory authorities disagreeing with our interpretation of data from pre-clinical studies or clinical trials; |
• | insufficient data collected from clinical trials to support the submission of an NDA or other submission or to obtain regulatory approval in Greater China, the United States or elsewhere; |
• | the NMPA, FDA, and EMA or comparable regulatory authorities not approving the manufacturing processes for our clinical and commercial supplies; |
• | changes in the approval policies or regulations of the NMPA, FDA or comparable regulatory authorities rendering our clinical data insufficient for approval; |
• | the NMPA, FDA or comparable regulatory authorities restricting the use of our products to a narrow population; and |
• | our CROs or licensors taking actions that materially and adversely impact the clinical trials. |
• | regulators or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence or conduct a clinical trial at a prospective trial site; |
• | we may experience delays in reaching, or may fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs who conduct clinical trials on our behalf, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
• | clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us or them, to conduct additional clinical trials or we may decide to abandon product development programs; |
• | the number of patients required for clinical trials of our products and product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate; |
• | third-party contractors used in our clinical trials may fail to comply with regulatory requirements or meet their contractual obligations in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that we add new clinical trial sites or investigators; |
• | the ability to conduct a companion diagnostic test to identify patients who are likely to benefit from our products and product candidates; |
• | we may elect to, or regulators, IRBs or ethics committees may require that we or our investigators, suspend or terminate clinical research for various reasons, including non-compliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks; |
• | the cost of clinical trials of our products and product candidates may be greater than we anticipate; |
• | the supply or quality of our products and product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and |
• | our products and product candidates may have undesirable side effects or unexpected characteristics, causing us or our investigators, regulators, IRBs or ethics committees to suspend or terminate the trials, or reports may arise from pre-clinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our products and product candidates. |
• | be delayed in obtaining regulatory approval for our products and product candidates; |
• | not obtain regulatory approval at all; |
• | obtain approval for indications or patient populations that are not as broad as intended or desired; |
• | be subject to post-marketing testing requirements; |
• | encounter difficulties obtaining or be unable to obtain reimbursement for use of our products and product candidates; |
• | be subject to restrictions on the distribution and/or commercialization of our products and product candidates; or |
• | have our products and product candidates removed from the market after obtaining regulatory approval. |
• | the severity of the disease under investigation; |
• | the total size and nature of the relevant patient population; |
• | the design and eligibility criteria for the clinical trial in question; |
• | the availability of an appropriate genomic screening test; |
• | the perceived risks and benefits of the product or product candidate under study; |
• | the efforts to facilitate timely enrollment in clinical trials; |
• | the patient referral practices of physicians; |
• | the availability of competing therapies also undergoing clinical trials; |
• | the ability to monitor patients adequately during and after treatment; |
• | the proximity and availability of clinical trial sites for prospective patients; and |
• | the occurrence of any pandemic, epidemic, including from the outbreak of COVID-19, or any other public health crises, natural catastrophe or other disasters may cause a delay in enrollment of patients in clinical trials. |
• | our revenue may be negatively impacted; |
• | the NMPA, FDA or other comparable regulatory authorities may withdraw or limit their approval of such products or product candidates; |
• | the NMPA, FDA or other comparable regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contra-indication; |
• | we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; |
• | we may be required to change the way such products or product candidates are distributed or administered, conduct additional clinical trials or change the labeling of our products or product candidates; |
• | the NMPA, FDA or other comparable regulatory authorities may require a Risk Evaluation and Mitigation Strategy, or REMS (or analogous requirement), plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; |
• | we may be subject to regulatory investigations and government enforcement actions; |
• | we may decide to remove such products or product candidates from the marketplace; |
• | we could be sued and held liable for injury caused to individuals exposed to or taking our products or product candidates; and |
• | our reputation may suffer. |
• | restrictions on the marketing or manufacturing of the product, withdrawal of the product or drug from the market, or voluntary or mandatory product recalls; |
• | fines, warning letters or holds on clinical trials; |
• | refusal by the NMPA, FDA or comparable regulatory authority to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals; |
• | drug seizure, detention or refusal to permit the import or export of the product; and |
• | injunctions or the imposition of civil, administrative or criminal penalties. |
• | efforts to enter into collaboration or licensing arrangements with third parties may increase our expenses or divert our management’s attention from the acquisition or development of product candidates; |
• | difficulty of effective enforcement of contractual provisions in local jurisdictions; |
• | potential third-party patent rights or potentially reduced protection for intellectual property rights; |
• | unexpected changes in tariffs, trade barriers and regulatory requirements, including the loss of normal trade status between mainland China and the United States; |
• | economic weakness, including inflation; |
• | compliance with tax, employment, immigration and labor laws for employees traveling abroad; |
• | the effects of applicable foreign tax structures and potentially adverse tax consequences; |
• | currency fluctuations, which could result in increased operating expenses and reduced revenue; |
• | workforce uncertainty and labor unrest; |
• | failure of our employees and contracted third parties to comply with the anti-bribery laws in mainland China, Office of Foreign Asset Control rules and regulations and the Foreign Corrupt Practices Act and other anti-bribery and corruption laws; and |
• | business interruptions resulting from geo-political actions, including trade disputes, war and terrorism, disease or public health epidemics, such as the coronavirus impacting mainland China and elsewhere, or natural disasters, including earthquakes, volcanoes, typhoons, floods, hurricanes and fires. |
• | issue ordinary shares that would dilute the percentage of ownership of the holders of our ordinary shares and/or ADSs; |
• | incur debt and assume liabilities; and |
• | incur amortization expenses related to intangible assets or incur large and immediate write-offs. |
• | problems integrating the purchased business, products, personnel or technologies; |
• | increases to our expenses; |
• | the failure to have discovered undisclosed liabilities of the acquired asset or company; |
• | diversion of management’s attention from their day-to-day |
• | harm to our operating results or financial condition; |
• | entrance into markets in which we have limited or no prior experience; and |
• | potential loss of key employees, particularly those of the acquired entity. |
• | obtain a manufacturing permit for each production facility from the NMPA and its relevant branches for the manufacture of drug and device products domestically; |
• | obtain a marketing authorization, which includes an approval number, from the NMPA for each drug or device for sale in mainland China; |
• | obtain a Pharmaceutical Distribution Permit from the provincial medical products administration if we were to sell drugs manufactured by third parties; and |
• | renew the Pharmaceutical Manufacturing Permits, the Pharmaceutical Distribution Permits and marketing authorizations every five years, among other requirements. |
• | the scope of rights granted under the license agreement and other interpretation-related issues; |
• | the extent to which our technology and processes infringe, misappropriate or otherwise violate on intellectual property of the licensor that is not subject to the licensing agreement; |
• | the sublicensing of patent and other rights under our collaborative development relationships; |
• | our diligence obligations under the license agreement and what activities satisfy those diligence obligations; |
• | the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and |
• | the priority of invention of patented technology. |
• | significant negative media attention and reputational damage; |
• | withdrawal of clinical trial subjects and inability to continue clinical trials; |
• | significant costs to defend the related litigation; |
• | substantial monetary awards to trial subjects or patients; |
• | the inability to commercialize any products or product candidates that we may develop; |
• | initiation of investigations by regulators; |
• | a diversion of management’s time and our resources; and |
• | a decline in the market price of our ordinary shares and/or our ADSs. |
• | obtain royalty-bearing licenses from such third party to such patents, which may not be available on commercially reasonable terms, if at all and even if we were able to obtain such licenses, they could be non-exclusive, thereby giving our competitors and other third parties access to the same technologies licensed to us, and could require us to make substantial licensing and royalty payments; |
• | defend litigation or administrative proceedings; |
• | reformulate product(s) so that it does not infringe the intellectual property rights of others, which may not be possible or could be very expensive and time consuming; |
• | cease developing, manufacturing and commercializing the infringing technology, products or product candidates; and |
• | pay such third party significant monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right. |
• | others may be able to make products that are similar to any product or product candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future; |
• | we, our licensors, patent owners of patent rights that we have in-licensed, or current or future collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future; |
• | we, our licensors, patent owners of patent rights that we have in-licensed, or current or future collaborators might not have been the first to file patent applications covering certain of our or their inventions; |
• | others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing, misappropriating or otherwise violating our owned or licensed intellectual property rights; |
• | it is possible that our pending licensed patent applications or those that we may own in the future will not lead to issued patents; |
• | issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors; |
• | our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; |
• | we may not develop additional proprietary technologies that are patentable; |
• | the patents of others may harm our business; and |
• | we may choose not to file a patent in order to maintain certain trade secrets or know how, and a third party may discover certain technologies containing such trade secrets or know how through independent research and development and/or subsequently file a patent covering such intellectual property. |
• | announcements of competitive developments; |
• | regulatory developments affecting us, our customers or our competitors; |
• | announcements regarding litigation or administrative proceedings involving us; |
• | actual or anticipated fluctuations in our period-to-period |
• | changes in financial estimates by securities research analysts; |
• | additions or departures of our executive officers; |
• | fluctuations of exchange rates between the RMB and the U.S. dollar; |
• | release or expiration of lock-up or other transfer restrictions on our outstanding ADSs or ordinary shares; and |
• | sales or perceived sales of additional ADSs or ordinary shares. |
• | Note: Reflects opening prices for 9/21/17, the date of initial trading of ZLAB ADSs, and closing prices for all other quarterly dates. |
9/21/17 |
9/30/17 |
12/31/17 |
3/31/18 |
6/30/18 |
9/30/18 |
12/31/18 |
3/31/19 |
6/30/19 |
9/30/19 |
|||||||||||||||||||||||||||||||
Zai Lab Limited |
$ | 100.00 | $ | 95.81 | $ | 75.34 | $ | 75.76 | $ | 82.51 | $ | 69.13 | $ | 82.40 | $ | 104.72 | $ | 123.74 | $ | 114.80 | ||||||||||||||||||||
NASDAQ Composite |
$ | 100.00 | $ | 100.73 | $ | 107.05 | $ | 109.54 | $ | 116.46 | $ | 124.78 | $ | 102.90 | $ | 119.86 | $ | 124.16 | $ | 124.05 | ||||||||||||||||||||
NASDAQ Biotechnology |
$ | 100.00 | $ | 100.45 | $ | 96.52 | $ | 96.46 | $ | 99.31 | $ | 110.29 | $ | 87.52 | $ | 101.00 | $ | 98.58 | $ | 89.94 |
12/31/19 |
3/31/20 |
6/30/20 |
9/30/20 |
12/31/20 |
3/31/21 |
6/30/21 |
9/30/21 |
12/31/21 |
||||||||||||||||||||||||||||
Zai Lab Limited |
$ | 147.59 | $ | 182.68 | $ | 291.45 | $ | 295.14 | $ | 480.27 | $ | 473.49 | $ | 628.07 | $ | 373.99 | $ | 223.03 | ||||||||||||||||||
NASDAQ Composite |
$ | 139.14 | $ | 119.41 | $ | 155.98 | $ | 173.18 | $ | 199.86 | $ | 205.42 | $ | 224.92 | $ | 224.06 | $ | 242.61 | ||||||||||||||||||
NASDAQ Biotechnology |
$ | 108.89 | $ | 97.55 | $ | 123.58 | $ | 122.41 | $ | 136.85 | $ | 135.87 | $ | 148.03 | $ | 146.23 | $ | 135.99 |
(i) | the primary location of the day-to-day |
(ii) | decisions relating to the enterprise’s financial and human resource matters are made or are subject to approval by organizations or personnel in mainland China; |
(iii) | the enterprise’s primary assets, accounting books and records, company seals, and board and shareholder resolutions, are located or maintained in mainland China; and |
(iv) | at least 50% of voting board members or senior executives habitually reside in mainland China. |
• | a citizen or individual resident of the United States; |
• | a corporation (or any other entity treated as a corporation for U.S. federal income tax purposes) organized in or under the laws of the United States or any state thereof, or the District of Columbia; |
• | an estate the income of which is subject to U.S. federal income taxation regardless of its source; or |
• | a trust if (i) it has a valid election in effect to be treated as a U.S. person for U.S. federal income tax purposes or (ii) a U.S. court can exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of its substantial decisions. |
• | banks or other financial institutions; |
• | insurance companies; |
• | real estate investment trusts; |
• | regulated investment companies; |
• | grantor trusts; |
• | tax-exempt organizations (including private foundations); |
• | persons holding ADSs or ordinary shares through a partnership (including an entity or arrangement treated as a partnership for U.S. federal income tax purposes) or S corporation; |
• | dealers or traders in securities, commodities or currencies (including those who use a mark-to-market |
• | persons whose functional currency for U.S. federal income tax purposes is not the U.S. dollar; |
• | certain former citizens and former long-term residents of the United States; |
• | persons who acquired our ADSs or ordinary shares pursuant to the exercise of any employee stock option or otherwise as compensation; |
• | persons holding ADSs or ordinary shares as part of a position in a straddle or as part of a hedging, wash sale, constructive sale, conversion or integrated transaction for U.S. federal income tax purposes; or |
• | direct, indirect or constructive owners of 10% or more of our total combined voting power or value. |
A. |
Operating Results. |
• | expenses incurred for payments to CROs, CMOs, investigators and clinical trial sites that conduct our clinical studies; |
• | employee compensation related expenses, including salaries, benefits and equity compensation expenses; |
• | expenses for licensors; |
• | the cost of acquiring, developing and manufacturing clinical study materials; |
• | facilities and other expenses, which include office leases and other overhead expenses; |
• | costs associated with pre-clinical activities and regulatory operations; |
• | expenses associated with the construction and maintenance of our manufacturing facilities; and |
• | costs associated with operating as a public company. |
(in thousands) |
Year ended December 31, |
|||||||||||||||
2021 |
% |
2020 |
% |
|||||||||||||
Revenues: |
||||||||||||||||
Product revenue, net |
$ | 144,105 | 99.9 | $ | 48,958 | 100.0 | ||||||||||
Collaboration revenue |
207 | 0.1 | — | 0.0 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 144,312 | 100.0 | $ | 48,958 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
(in thousands) |
Year ended December 31, |
|||||||||||||||
2021 |
% |
2020 |
% |
|||||||||||||
Product revenue, net: |
||||||||||||||||
ZEJULA |
$ | 93,579 | 64.9 | $ | 32,138 | 65.7 | ||||||||||
Optune |
38,903 | 27.0 | 16,418 | 33.5 | ||||||||||||
QINLOCK |
11,620 | 8.1 | 402 | 0.8 | ||||||||||||
NUZYRA |
3 | 0.0 | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 144,105 | 100.0 | $ | 48,958 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
(in thousands) |
Year ended December 31, |
|||||||||||||||
2021 |
% |
2020 |
% |
|||||||||||||
Research and development expenses: |
||||||||||||||||
Personnel compensation and related costs |
$ | 77,227 | 13.5 | $ | 40,257 | 18.1 | ||||||||||
Licensing fees |
384,104 | 67.0 | 108,169 | 48.6 | ||||||||||||
Payment to CROs/CMOs/Investigators |
82,571 | 14.4 | 53,275 | 23.9 | ||||||||||||
Other costs |
29,404 | 5.1 | 21,010 | 9.4 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 573,306 | 100.0 | $ | 222,711 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
• | $37.0 million for increased personnel compensation and related costs which was primarily attributable to increased employee compensation costs, due to hiring of more personnel during the year ended December 31, 2021 and the grants of new share options and vesting of restricted shares to certain employees; |
• | $275.9 million for increased licensing fees in connection with the upfront and milestone fee paid for licensing agreements; |
• | $29.3 million for increased payment to CROs/CMOs/Investigators during the year ended December 31, 2021 as we advanced our drug candidate pipeline; and |
• | $8.4 million for increased lab consumables and other cost during the year ended December 31, 2021. |
(in thousands) |
Year ended December 31, |
|||||||||||||||
2021 |
% |
2020 |
% |
|||||||||||||
Research and development expenses: |
||||||||||||||||
Clinical programs |
$ | 433,021 | 75.5 | $ | 160,674 | 72.1 | ||||||||||
Pre-clinical programs |
47,768 | 8.3 | 10,598 | 4.8 | ||||||||||||
Unallocated research and development expenses |
92,517 | 16.2 | 51,439 | 23.1 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 573,306 | 100.0 | $ | 222,711 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
(in thousands) |
Year ended December 31, |
|||||||||||||||
2021 |
% |
2020 |
% |
|||||||||||||
Selling, General and Administrative Expenses: |
||||||||||||||||
Personnel compensation and related costs |
$ | 124,675 | 57.0 | $ | 63,010 | 56.6 | ||||||||||
Professional service fees |
22,901 | 10.5 | 12,751 | 11.5 | ||||||||||||
Other costs |
71,255 | 32.5 | 35,551 | 31.9 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 218,831 | 100.0 | $ | 111,312 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
• | $61.7 million for increased personnel compensation and related costs which was primarily attributable to increased commercial and administrative personnel costs, due to hiring of more personnel during year ended December 31, 2021 and the grants of new share options and vesting of restricted shares to certain employees; |
• | $10.1 million for increased professional service fee, mainly attributable to our increased legal, compliance, accounting and investor and public relations expenses associated with being a public company and in connection with sales of ZEJULA, Optune, QINLOCK and NUZYRA in mainland China after our commercial launch of these four commercialized products; and |
• | $35.7 million for increased other costs, mainly including selling, rental, and administrative expenses primary attributable to the commercial operation in Hong Kong, Taiwan and mainland China. |
(in thousands) |
Year ended December 31, |
|||||||||||||||
2020 |
% |
2019 |
% |
|||||||||||||
Product revenue, net: |
||||||||||||||||
ZEJULA |
$ | 32,138 | 65.7 | $ | 6,625 | 51.0 | ||||||||||
Optune |
16,418 | 33.5 | 6,360 | 49.0 | ||||||||||||
QINLOCK |
402 | 0.8 | — | 0.0 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 48,958 | 100.0 | $ | 12,985 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
(in thousands) |
Year ended December 31, |
|||||||||||||||
2020 |
% |
2019 |
% |
|||||||||||||
Research and development expenses: |
||||||||||||||||
Personnel compensation and related costs |
$ | 40,257 | 18.1 | $ | 30,820 | 21.6 | ||||||||||
Licensing fees |
108,169 | 48.6 | 58,682 | 41.3 | ||||||||||||
Payment to CROs/CMOs/Investigators |
53,275 | 23.9 | 36,814 | 25.9 | ||||||||||||
Other costs |
21,010 | 9.4 | 15,905 | 11.2 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 222,711 | 100.0 | $ | 142,221 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
• | $9.4 million for increased personnel compensation and related costs which was primarily attributable to increased employee compensation costs, due to hiring of more personnel during the year ended December 31, 2020, and the grants of new share options and vesting of restricted shares to certain employees; |
• | $49.5 million for increased licensing fees in connection with the upfront and milestone fee paid for licensing agreement; |
• | $16.5 million for increased payment to CROs/CMOs/Investigators in fiscal year 2020 as we advanced our drug candidate pipeline; and |
• | $5.1 million for increased lab consumables and professional service expenses. |
(in thousands) |
Year ended December 31, |
|||||||||||||||
2020 |
% |
2019 |
% |
|||||||||||||
Research and development expenses: |
||||||||||||||||
Clinical programs |
$ | 160,674 | 72.1 | $ | 96,442 | 67.8 | ||||||||||
Pre-clinical programs |
10,598 | 4.8 | 8,268 | 5.8 | ||||||||||||
Unallocated research and development expenses |
51,439 | 23.1 | 37,511 | 26.4 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 222,711 | 100.0 | $ | 142,221 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
(in thousands) |
Year ended December 31, |
|||||||||||||||
2020 |
% |
2019 |
% |
|||||||||||||
Selling, General and Administrative Expenses: |
||||||||||||||||
Personnel compensation and related costs |
$ | 63,010 | 56.6 | $ | 43,572 | 62.1 | ||||||||||
Professional service fees |
12,751 | 11.5 | 2,887 | 4.1 | ||||||||||||
Other costs |
35,551 | 31.9 | 23,752 | 33.8 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
$ | 111,312 | 100.0 | $ | 70,211 | 100.0 | ||||||||||
|
|
|
|
|
|
|
|
• | $19.4 million for increased personnel compensation and related costs which was primarily attributable to increased commercial and administrative personnel costs, due to hiring of more personnel during year ended December 31, 2020, and the grants of new share options and vesting of restricted shares to certain employees; |
• | $9.9 million for increased professional service fee, mainly attributable to our increased legal, compliance, accounting and investor and public relations expenses associated with being a public company and in connection with sales of ZEJULA and Optune in mainland China after our commercial launch of these two commercialized products; and |
• | $11.8 million for increased other costs, mainly including selling, rental, and administrative expenses primary attributable to the commercial operation in Hong Kong and mainland China. |
(in thousands) |
Year ended December 31, |
|||||||||||
2019 |
2020 |
2021 |
||||||||||
Net cash used in operating activities |
$ | (191,011 | ) | $ | (216,055 | ) | $ | (549,231 | ) | |||
Net cash provided by (used in) investing activities |
(14,892 | ) | (554,830 | ) | 249,957 | |||||||
Net cash provided by financing activities |
219,302 | 1,132,440 | 820,202 | |||||||||
Effect of foreign exchange rate changes |
91 | 4,862 | 1,116 | |||||||||
|
|
|
|
|
|
|||||||
Net increases in cash, cash equivalents and restricted cash |
$ | 13,490 | $ | 366,417 | $ | 522,044 | ||||||
|
|
|
|
|
|
(a) |
Disclosure Controls and Procedures |
(b) |
Management’s Annual Report on Internal Control over Financial Reporting |
(c) |
Report of Registered Accounting Firm |
(d) |
Changes in Internal Control over Financial Reporting |
* | Filed herewith |
** | Furnished herewith |
# | Management contract or compensatory plan |
+ | Confidential treatment has been granted as to certain portions, which portions have been omitted and submitted separately to the Securities and Exchange Commission. |
^ | Certain confidential information contained in this exhibit has been omitted because it (i) is not material and (ii) would be competitively harmful if publicly disclosed. |
Signature |
Title |
Date | ||
/s/ Samantha (Ying) Du Samantha (Ying) Du |
Chief Executive Officer and Chairwoman (Principal Executive Officer) |
March 1, 2022 | ||
/s/ Billy Cho Billy Cho |
Chief Financial Officer (Principal Financial and Accounting Officer) |
March 1, 2022 | ||
/s/ John Diekman John Diekman |
Director |
March 1, 2022 | ||
/s/ Kai-Xian Chen Kai-Xian Chen |
Director |
March 1, 2022 | ||
/s/ Nisa Leung Nisa Leung |
Director |
March 1, 2022 | ||
/s/ William Lis William Lis |
Director |
March 1, 2022 | ||
/s/ Leon O. Moulder, Jr. Leon O. Moulder, Jr. |
Director |
March 1, 2022 | ||
/s/ Peter Wirth Peter Wirth |
Director |
March 1, 2022 | ||
/s/ Richard Gaynor Richard Gaynor |
Director |
March 1, 2022 | ||
/s/ Scott Morrison Scott Morrison |
Director |
March 1, 2022 |
ZAI LAB LIMITED | ||||
Date: March 1, 2022 |
By: | /s/ Samantha (Ying) Du | ||
Name: | Samantha (Ying) Du | |||
Title: | Chief Executive Officer |
Page |
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F-2 |
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F-5 |
||||
F-6 |
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F-7 |
||||
F-8 |
||||
F-9 |
||||
F-11 |
||||
F-47 |
• |
We tested the effectiveness of key controls over the accrual of the R&D expenses payable to the Outsourced Service Providers. |
• |
We obtained and read the key terms set out in the research agreements with Outsourced Service Providers and evaluated the completion status with reference to the progress reported by the representatives of the Outsourced Service Providers, on a sample basis, to determine whether the service fees were recorded based on respective contract sums, progress and/or milestones achieved. |
• |
We sent audit confirmations to Outsourced Service Providers, on a sample basis, to confirm the amount of the R&D service fees incurred for the year ended December 31, 2021 and the amounts payable under the contracts as of December 31, 2021. |
• |
We selected projects from the open contract list as of December 31, 2021 on a sample basis, made inquiries of responsible personnel regarding the project status and inspected invoices and other communications from the Outsourced Service Providers to identify potential additional Outsourced Service Providers and related unrecorded R&D expenditures. |
As of December 31, |
||||||||||||
2020 |
2021 |
|||||||||||
Notes |
$ |
$ |
||||||||||
Assets |
||||||||||||
Current assets: |
||||||||||||
Cash and cash equivalents |
3 | |||||||||||
Short-term investments |
5 | |||||||||||
Accounts receivable (net of allowance for credit loss of $ |
6 | |||||||||||
Notes receivable |
||||||||||||
Inventories |
7 | |||||||||||
Prepayments and other current assets |
||||||||||||
|
|
|
|
|||||||||
Total current assets |
||||||||||||
Restricted cash, non-current |
4 | |||||||||||
Long-term investments (including the fair value measured investment of |
8 | |||||||||||
Prepayments for equipment |
||||||||||||
Property and equipment, net |
9 | |||||||||||
Operating lease right-of-use |
10 | |||||||||||
Land use rights, net |
||||||||||||
Intangible assets, net |
||||||||||||
Long-term deposits |
||||||||||||
Value added tax recoverable |
||||||||||||
|
|
|
|
|||||||||
Total assets |
||||||||||||
|
|
|
|
|||||||||
Liabilities and shareholders’ equity |
||||||||||||
Current liabilities: |
||||||||||||
Accounts payable |
||||||||||||
Current operating lease liabilities |
10 | |||||||||||
Other current liabilities |
13 | |||||||||||
|
|
|
|
|||||||||
Total current liabilities |
||||||||||||
Deferred income |
||||||||||||
Non-current operating lease liabilities |
10 | |||||||||||
|
|
|
|
|||||||||
Total liabilities |
||||||||||||
|
|
|
|
|||||||||
Commitments and contingencies (Note 20) |
||||||||||||
Shareholders’ equity |
||||||||||||
Ordinary shares (par value of $ |
||||||||||||
Additional paid-in capital |
||||||||||||
Accumulated deficit |
( |
) | ( |
) | ||||||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||||||
Treasury s toc (at cost, k |
( |
) | ||||||||||
|
|
|
|
|||||||||
Total shareholders’ equity |
||||||||||||
|
|
|
|
|||||||||
Total liabilities and shareholders’ equity |
||||||||||||
|
|
|
|
Year ended December 31, |
||||||||||||||||
2019 |
2020 |
2021 |
||||||||||||||
Notes |
$ |
$ |
$ |
|||||||||||||
Revenues: |
||||||||||||||||
Product revenue, net |
11 | |||||||||||||||
Collaboration revenue |
||||||||||||||||
Total revenues |
||||||||||||||||
Expenses: |
||||||||||||||||
Cost of sales |
( |
) | ( |
) | ( |
) | ||||||||||
Research and development |
( |
) | ( |
) | ( |
) | ||||||||||
Selling, general and administrative |
( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ||||||||||
Interest income |
||||||||||||||||
Interest expenses |
( |
) | ( |
) | ||||||||||||
Other income (expenses), net |
( |
) | ||||||||||||||
|
|
|
|
|
|
|||||||||||
Loss before income tax and share of loss from equity method investment |
( |
) | ( |
) | ( |
) | ||||||||||
Income tax expense |
12 | |||||||||||||||
Share of loss from equity method investment |
( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Net loss |
( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Net loss attributable to ordinary shareholders |
( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|||||||||||
Loss per share — basic and diluted |
14 | ( |
) | ( |
) | ( |
) | |||||||||
Weighted-average shares used in calculating net loss per ordinary share — basic and diluted |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Net loss |
( |
) | ( |
) | ( |
) | ||||||
Other comprehensive income (loss), net of tax of |
||||||||||||
Foreign currency translation adjustments |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Comprehensive loss |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
Ordinary shares |
Additional paid in capital |
Accumulated other comprehensive income (loss) |
Treasury Stock |
|||||||||||||||||||||||||||||
Number of Shares |
Amount |
Accumulated deficit |
Number of Shares |
Amount |
Total |
|||||||||||||||||||||||||||
$ |
$ |
$ |
$ |
$ |
$ |
|||||||||||||||||||||||||||
Balance at January 1, 2019 |
( |
) | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares |
— | — | — | — | — | |||||||||||||||||||||||||||
Exercise of shares option |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $ |
— | — | — | — | ||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Foreign currency translation |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Balance at December 31, 2019 |
( |
) | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares |
— | — | — | — | — | |||||||||||||||||||||||||||
Exercise of shares option |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $ |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon secondary listing, net of issuance cost of $ |
— | — | — | — | ||||||||||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Foreign currency translation |
— | — | — | — | ( |
) | — | — | ( |
) | ||||||||||||||||||||||
Balance at December 31, 2020 |
( |
) | ( |
) | — | — | ||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares |
— | — | — | — | — | |||||||||||||||||||||||||||
Exercise of shares option |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $ |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance of ordinary shares in connection with collaboration and license arrangement (Note 17) |
— | — | — | — | ||||||||||||||||||||||||||||
Issuance cost adjustment for secondary listing |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation |
— | — | — | — | — | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||
Share-based compensation |
— | — | — | — | — | — | ||||||||||||||||||||||||||
Net loss |
— | — | — | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||||
Foreign currency translation |
— | — | — | — |
( |
) | — | — | ( |
) | ||||||||||||||||||||||
Balance at December 31, 2021 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Operating activities |
||||||||||||
Net loss |
( |
) | ( |
) | ( |
) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Allowance for credit loss |
— | |||||||||||
Inventory write-down |
— | |||||||||||
Depreciation and amortization expenses |
||||||||||||
Amortization of deferred income |
( |
) | ( |
) | ( |
) | ||||||
Share-based compensation |
||||||||||||
Noncash research and development expenses |
— | — | ||||||||||
Share of loss from equity method investment |
||||||||||||
Loss from fair value changes of equity investment with readily determinable fair value |
— | — | ||||||||||
Loss (gain) on disposal of property and equipment |
( |
) | ||||||||||
Noncash lease expenses |
||||||||||||
Changes in operating assets and liabilities: |
||||||||||||
Accounts receivable |
( |
) | ( |
) | ( |
) | ||||||
Notes receivable |
— | — | ( |
) | ||||||||
Inventories |
( |
) | ( |
) | ( |
) | ||||||
Prepayments and other current assets |
( |
) | ( |
) | ( |
) | ||||||
Long-term deposits |
( |
) | ( |
) | ||||||||
Value added tax recoverable |
( |
) | ( |
) | ( |
) | ||||||
Accounts payable |
( |
) | ||||||||||
Other current liabilities |
( |
) | ||||||||||
Operating lease liabilities |
( |
) | ( |
) | ( |
) | ||||||
Deferred income |
||||||||||||
|
|
|
|
|
|
|||||||
Net cash used in operating activities |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Cash flows from investing activities: |
||||||||||||
Purchases of short-term investments |
( |
) | ( |
) | ( |
) | ||||||
Proceeds from maturity of short-term investments |
||||||||||||
Purchase of investment in equity investee |
— | — | ( |
) | ||||||||
Purchase of property and equipment |
( |
) | ( |
) | ( |
) | ||||||
Disposal of property and equipment |
— | — | ||||||||||
Purchase of land use rights |
( |
) | — | — | ||||||||
Purchase of intangible assets |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Net cash provided by ( used in) investing activities |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from short-term borrowings |
— | — | ||||||||||
Repayment of short-term borrowings |
( |
) | ( |
) | — | |||||||
Proceeds from exercises of stock options |
||||||||||||
Proceeds from issuance of ordinary shares upon public offerings |
||||||||||||
Payment of public offering costs |
( |
) | ( |
) | ( |
) | ||||||
Employee taxes paid related to settlement of equity awards |
— | — | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Net cash provided by financing activities |
||||||||||||
|
|
|
|
|
|
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash |
||||||||||||
|
|
|
|
|
|
|||||||
Net increase in cash, cash equivalents and restricted cash |
||||||||||||
Cash, cash equivalents and restricted cash — beginning of the year |
||||||||||||
|
|
|
|
|
|
|||||||
Cash, cash equivalents and restricted cash — end of the year |
||||||||||||
|
|
|
|
|
|
|||||||
Supplemental disclosure on non-cash investing and financing activities: |
||||||||||||
Payables for purchase of property and equipment |
||||||||||||
Payables for intangible assets |
— | |||||||||||
Payables for public offering costs |
— | — | ||||||||||
Payables for treasury stock |
— | — | ||||||||||
Supplemental disclosure of cash flow information: |
||||||||||||
Cash and cash equivalents |
||||||||||||
Restricted cash, non-current |
||||||||||||
|
|
|
|
|
|
|||||||
Total cash and cash equivalents and restricted cash |
||||||||||||
|
|
|
|
|
|
|||||||
Interest paid |
1. |
Organization and principal activities |
Name of company |
Place of incorporation |
Date of incorporation |
Percentage of ownership |
Principal activities | ||||
Zai Lab (Hong Kong) Limited |
||||||||
Zai Lab (Shanghai) Co., Ltd. |
China |
2014 |
||||||
Zai Lab (AUST) Pty., Ltd. |
2014 |
|||||||
Zai Lab (Suzhou) Co., Ltd. |
China |
2015 |
||||||
Zai Biopharmaceutical (Suzhou) Co., Ltd. |
China |
|||||||
Zai Lab (US) LLC |
States |
|||||||
Zai Lab International Trading (Shanghai) Co., Ltd. |
China |
2019 |
||||||
Zai Auto Immune (Hong Kong) Limited |
2020 |
,|||||||
Zai Lab (Taiwan) Limited |
2020 |
2. |
Summary of significant accounting policies |
Useful life | ||
Office equipment |
||
Electronic equipment |
||
Vehicle |
||
Laboratory equipment |
||
Manufacturing equipment |
||
Leasehold improvements |
Description |
Fair Value as of December 31, 2021 |
Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) |
||||||
US$ |
US$ |
|||||||
Equity Investments with Readily Determinable Fair Value |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
A |
* | * | ||||||||||
B |
* | * | ||||||||||
C |
* |
* | Represents less than 10% of revenue for the years ended December 31, 2019, 2020 and 2021. |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
F |
* | * | ||||||||||
G |
* | * | ||||||||||
H |
* | * | ||||||||||
I |
* | * | ||||||||||
J |
* | * | ||||||||||
K |
* | * |
* |
Represents less than 10% of research and development expenses and the inventory purchases for the years ended December 31, 2019, 2020 and 2021. |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
C |
||||||||
D |
* |
|||||||
E |
* |
* |
Represents less than |
3. |
Cash and cash equivalents |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Cash at bank and in hand |
||||||||
Cash equivalents (note (i)) |
||||||||
Denominated in: |
||||||||
US$ |
||||||||
RMB (note (ii)) |
||||||||
Hong Kong dollar (“HK$” ) |
||||||||
Australian dollar (“A$”) |
||||||||
Taiwan dollar (“TW$”) |
||||||||
(i) | Cash equivalents represent short-term and highly liquid investments in a money market fund. |
(ii) | Certain cash and bank balances denominated in RMB were deposited with banks in mainland China. The conversion of these RMB denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the Chi government.nese |
4. |
Restricted cash, non-current |
5. |
Short-term investments |
6. |
Accounts receivable |
Allowance for Credit Losses |
||||
$ |
||||
Balance as of December 31, 2020 |
||||
Current period provision for expected credit losses |
||||
Amounts written-off |
— | |||
Recoveries of amounts previously written-off |
— | |||
Balance as of December 31, 2021 |
||||
7. |
Inventories |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Finished goods |
||||||||
Raw materials |
||||||||
Work in progress |
— | |||||||
Inventories |
||||||||
8. |
Long-term investments |
9. |
Property and equipment, net |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Office equipment |
||||||||
Electronic equipment |
||||||||
Vehicle |
||||||||
Laboratory equipment |
||||||||
Manufacturing equipment |
||||||||
Leasehold improvements |
||||||||
Construction in progress |
||||||||
Less: accumulated depreciation |
( |
) | ( |
) | ||||
Property and equipment, net |
||||||||
10. |
Lease |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Operating fixed lease cost |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Cash paid for amounts included in measurement of lease liabilities |
||||||||||||
Non-cash operating lease liabilities arising from obtaining operating right-of-use |
Year ended December 31 |
||||
$ |
||||
2022 |
||||
2023 |
||||
2024 |
||||
2025 |
||||
2026 |
||||
Thereafter |
||||
|
|
|||
Total lease payments |
||||
Less: imputed interest |
( |
) | ||
|
|
|||
Present value of minimum operating lease payments |
||||
|
|
Year ended December 31, |
||||||||
2020 |
2021 |
|||||||
Weighted-average remaining lease term |
||||||||
Weighted-average discount rate |
% | % |
11. |
Product revenue, net |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Product revenue — gross |
||||||||||||
Less: Rebate and sales return |
— | ( |
) | ( |
) | |||||||
|
|
|
|
|
|
|||||||
Product revenue — net |
||||||||||||
|
|
|
|
|
|
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
ZEJULA |
||||||||||||
Optune |
||||||||||||
QINLOCK |
— | |||||||||||
NUZYRA |
— | — | ||||||||||
|
|
|
|
|
|
|||||||
Total product revenue — net |
||||||||||||
|
|
|
|
|
|
12. |
Income Tax |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Cayman |
( |
) | ||||||||||
BVI |
||||||||||||
Mainland China |
||||||||||||
HK |
||||||||||||
US |
||||||||||||
AUST |
||||||||||||
TW |
— | — | ||||||||||
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Statutory income tax rate |
% | % | % | |||||||||
Share-based compensations |
( |
%) | ( |
%) | ( |
%) | ||||||
Non-deductible expenses |
( |
%) | ( |
%) | ( |
%) | ||||||
Prior year tax filing adjustment |
% | % | % | |||||||||
Effect of different tax rate of subsidiary operation in other jurisdictions |
% | ( |
%) | ( |
%) | |||||||
Preferential tax rate |
( |
%) | ( |
%) | ( |
%) | ||||||
Effect of change in tax rate |
( |
%) | — | — | ||||||||
Changes in valuation allowance |
( |
%) | ( |
%) | ( |
%) | ||||||
Effective income tax rate |
— | — | — | |||||||||
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Deferred tax assets: |
||||||||||||
Depreciation of property and equipment, net |
||||||||||||
Government grants |
||||||||||||
Deferred revenue |
— | |||||||||||
Public welfare donations |
— | |||||||||||
Net operating loss carry forwards |
||||||||||||
Less: valuation allowance |
( |
) | ( |
) | ( |
) | ||||||
Deferred tax assets, net |
— | — | — | |||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Balance as of January 1, |
( |
) | ( |
) | ||||
Additions |
( |
) | ( |
) | ||||
Balance as of December 31, |
( |
) | ( |
) | ||||
13. |
Other current liabilities |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Payroll |
||||||||
Accrued professional service fee |
||||||||
Payables for purchase of property and equipment |
||||||||
Accrued rebate to distributors |
||||||||
Tax payables |
||||||||
Others (note (i)) |
||||||||
Total |
||||||||
(i) | Others are mainly payables to employees for exercising the share-based compensations, payables related to travel and business entertainment expenses. |
14. |
Loss per share |
For the years ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Numerator: |
||||||||||||
Net loss attributable to ordinary shareholders |
( |
) | ( |
) | ( |
) | ||||||
Denominator: |
||||||||||||
Weighted average number of ordinary shares- basic and diluted |
||||||||||||
Net loss per share-basic and diluted |
( |
) | ( |
) | ( |
) | ||||||
As of December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
Share options |
||||||||||||
Non-vested restricted shares |
15. |
Related party transactions |
Company Name |
Relationship with the Company | |
MEDx (Suzhou) Translational Medicine Co., Ltd. |
16. |
Share-based compensation |
2019 |
2020 |
2021 | ||||
Risk-free rate of return |
||||||
Contractual life of option |
||||||
Expected term |
6, 6.25 or 6.5 | |||||
Estimated volatility rate |
||||||
Expected dividend yield |
||||||
Fair value of underlying ordinary shares |
$ |
$ |
$ |
Number of options |
Weighted average exercise price |
Weighted average remaining contractual term |
Aggregate intrinsic value |
|||||||||||||
$ |
Years |
$ |
||||||||||||||
Outstanding at December 31, 2020 |
||||||||||||||||
Granted |
— | — | ||||||||||||||
Exercised |
( |
) | — | — | ||||||||||||
Forfeited |
( |
) | — | — | ||||||||||||
Outstanding at December 31, 2021 |
||||||||||||||||
Vested and exercisable as of December 31, 2021 |
||||||||||||||||
Vested or expected to vest as of December 31, 2021 |
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Selling, general and administrative |
||||||||||||
Research and development |
||||||||||||
Total |
||||||||||||
Numbers of non-vested restricted shares |
Weighted average grant date fair value |
|||||||
$ |
||||||||
Non-vested as of December 31, 2020 |
||||||||
Granted |
||||||||
Vested |
( |
) | ||||||
Forfeited |
( |
) | ||||||
Non-vested as of December 31, 2021 |
||||||||
Year ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Selling, general and administrative |
||||||||||||
Research and development |
||||||||||||
Total |
||||||||||||
17. |
Licenses and collaborative arrangement |
18. |
Restricted net assets |
19. |
Employee defined contribution plan |
20. |
Commitments and Contingencies |
(a) |
Purchase commitments |
(b) |
Contingencies |
21. |
Selected quarterly financial data (unaudited) |
Quarter Ended, |
||||||||||||||||
2021 |
March 31, |
June 30, |
September 30, |
December 31, |
||||||||||||
$ |
$ |
$ |
$ |
|||||||||||||
Product revenue, net |
||||||||||||||||
Collaboration revenue |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Net loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Net loss attributable to ordinary shareholders |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Basic and diluted net loss per share |
( |
) | ( |
) | ( |
) | ( |
) |
Quarter Ended, |
||||||||||||||||
2020 |
March 31, |
June 30, |
September 30, |
December 31, |
||||||||||||
$ |
$ |
$ |
$ |
|||||||||||||
Product revenue, net |
||||||||||||||||
Loss from operations |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Net loss |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Net loss attributable to ordinary shareholders |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Basic and diluted net loss per share |
( |
) | ( |
) | ( |
) | ( |
) |
22. |
Subsequent events |
As of December 31, |
||||||||
2020 |
2021 |
|||||||
$ |
$ |
|||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
||||||||
Short-term investments |
||||||||
Prepayments and other current assets |
||||||||
|
|
|
|
|||||
Total current assets |
||||||||
Investment in subsidiaries |
||||||||
|
|
|
|
|||||
Total assets |
||||||||
|
|
|
|
|||||
Liabilities and shareholders’ equity |
||||||||
Liabilities |
||||||||
Current liabilities: |
||||||||
Other current liabilities |
||||||||
|
|
|
|
|||||
Total current liabilities |
||||||||
Deferred income |
||||||||
|
|
|
|
|||||
Total liabilities |
||||||||
|
|
|
|
|||||
Shareholders’ equity |
||||||||
Ordinary shares (par value of US$ |
||||||||
Additional paid-in capital |
||||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Additional other comprehensive income |
( |
) | ( |
) | ||||
|
|
|
|
|||||
Treasury stock |
— | ( |
) | |||||
|
|
|
|
|||||
Total shareholders’ equity |
||||||||
|
|
|
|
|||||
Total liabilities and shareholders’ equity |
||||||||
|
|
|
|
Year Ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Operating Expenses: |
||||||||||||
Research and development |
( |
) | ( |
) | ( |
) | ||||||
General and administrative |
( |
) | ( |
) | ( |
) | ||||||
|
|
|
|
|
|
|||||||
Loss from operations |
( |
) |
( |
) |
( |
) | ||||||
Interest income |
||||||||||||
Other income (expenses), net |
( |
) | ||||||||||
|
|
|
|
|
|
|||||||
Profit ( Loss) before income tax and equity in loss of subsidiaries |
( |
) |
( |
) | ||||||||
Equity in loss of subsidiaries |
( |
) | ( |
) | ( |
) | ||||||
Income tax expense |
||||||||||||
|
|
|
|
|
|
|||||||
Net loss attributable to Zai Lab Limited |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
|||||||
Net loss |
( |
) | ( |
) | ( |
) | ||||||
Other comprehensive income (loss) , net of tax of nil: |
||||||||||||
Foreign currency translation adjustment |
( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|||||||
Comprehensive loss |
( |
) |
( |
) |
( |
) | ||||||
|
|
|
|
|
|
Year Ended December 31, |
||||||||||||
2019 |
2020 |
2021 |
||||||||||
$ |
$ |
$ |
||||||||||
Cash flows from Operating activities: |
||||||||||||
Net loss |
( |
) | ( |
) | ( |
) | ||||||
Adjustments to reconcile net loss to net cash provided by operating activities: |
||||||||||||
Amortization of deferred income |
( |
) | ( |
) | ( |
) | ||||||
Share based compensation |
||||||||||||
Equity in loss of subsidiaries |
||||||||||||
Loss from fair value changes of equity investment of readily determinable fair value |
— | — | ||||||||||
Changes in operating assets and liabilities: |
||||||||||||
Prepayments and other current assets |
( |
) | ( |
) | ||||||||
Other current liabilities |
( |
) | ||||||||||
Net cash provided by (used in) operating activities |
( |
) | ||||||||||
Cash flows from investing activities: |
||||||||||||
Purchases of short-term investments |
( |
) | ( |
) | ( |
) | ||||||
Proceeds from maturity of short-term investments |
||||||||||||
Purchase of investment in equity investee |
— |
— |
( |
) | ||||||||
Investment in subsidiaries |
( |
) | ( |
) | ( |
) | ||||||
Net cash used in investing activities |
( |
) | ( |
) | ( |
) | ||||||
Cash flows from financing activities: |
||||||||||||
Proceeds from exercises of stock options |
||||||||||||
Proceeds from issuance of ordinary shares upon public offerings |
||||||||||||
Payment of public offering costs |
( |
) | ( |
) | ( |
) | ||||||
Employee taxes paid related to settlement of equity awards |
— | — | ( |
) | ||||||||
Net cash provided by financing activities |
||||||||||||
Effect of foreign exchange rate changes on cash and cash equivalent |
— | ( |
) | |||||||||
Net increase in cash and cash equivalents |
||||||||||||
Cash and cash equivalents-beginning of the year |
||||||||||||
Cash and cash equivalents-end of the year |
||||||||||||
Exhibit 10.6
ZAI LAB LIMITED
NON-EMPLOYEE DIRECTOR COMPENSATION POLICY
As of November 19, 2021, each individual who provides services to Zai Lab Limited (the Company) as a director, other than a director who is employed by the Company or an affiliate, (a Non-Employee Director) shall be entitled to receive the following amounts of compensation:
Type of Compensation |
Amount and Form of Payment | |
Annual cash retainer | $50,000 (payable in cash on a quarterly basis) | |
Equity retainer | Commencing in calendar year 2022, each Non-Employee Director is eligible to receive, effective as of a date designated by the Board of Directors (the Date of Grant), an annual grant of a number of shares of Restricted Stock (as defined in the 2017 Equity Incentive Plan) equal to US$500,000 divided by the closing price of the Companys ADS on NASDAQ on the Date of Grant (or on the next succeeding business day if the NASDAQ stock market is not open for trading on the Date of Grant), rounded down to the nearest whole share. Such shares of Restricted Stock shall vest in full on the first anniversary of the Date of Grant, subject to continued service as a member of our board of directors through such date. | |
New Member Grant | Commencing in calendar year 2021, each Non-Employee Director newly elected to the Board of Directors is eligible to receive, effective as of the date of his or her election to the Board of Directors (the Date of Election), an initial grant of a number of shares of Restricted Stock (as defined in the 2017 Equity Incentive Plan) equal to US$750,000 divided by the closing price of the Companys ADS on NASDAQ on the Date of Election (or on the next succeeding business day if the NASDAQ stock market is not open for trading on the Date of Election), rounded down to the nearest whole share. Such shares of Restricted Stock shall vest with respect to one-third of the initial grant on each of the next three anniversaries of the Date of Election, subject to continued service as a member of our board of directors through such date.
In the event that a newly elected Non-Employee Directors Date of Election is less than 180 days prior to the Date of Grant of the next annual grant to Non-Employee Director, such newly elected Non-Employee Director shall not be eligible to participate in that particular annual grant, but shall participate in all subsequent annual grants. | |
Additional annual cash retainer for Audit Committee chair |
$20,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Audit Committee member | $10,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Compensation Committee chair |
$15,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Compensation Committee member |
$7,500 (payable in cash on a quarterly basis) |
Additional annual cash retainer for Nominating Committee chair |
$10,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Nominating Committee member | $5,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Research and Development Committee chair |
$10,000 (payable in cash on a quarterly basis) | |
Additional annual cash retainer for Research and Development Committee member | $5,000 (payable in cash on a quarterly basis) | |
Annual Limit on Non-Employee Director Compensation | The total compensation of each individual Non-Employee Director (including cash retainers and equity grants) shall not exceed US$750,000 in any calendar year or US$1,000,000 in the initial calendar year of such Non-Employee Directors service, as the case may be. |
Cash retainers shall be pro-rated for service for periods of less than a full calendar quarter. In addition, Non-Employee Directors will be reimbursed by the Company for reasonable and customary expenses incurred in connection with attendance at board of director and committee meetings, in accordance with the Companys policies as in effect from time to time.
For the avoidance of doubt, directors who are (i) employees of the Company, (ii) employees of one of its affiliates or (iii) (a) are affiliated with a shareholder holding more than one percent (1%) of the ordinary shares or ordinary share equivalents of the Company or (b) individually (or through any trust or estate planning entity) hold more than one percent (1%) of the ordinary shares or ordinary share equivalents) of the Company will not receive compensation for their service as a director, other than reimbursement for reasonable and customary expenses incurred in connection with attendance at board of director and committee meetings, in accordance with the Companys policies as in effect from time to time.
Exhibit 10.23
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II)
IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
Confidential
Execution Version
LICENSE AND COLLABORATION AGREEMENT
by and between
Blueprint Medicines Corporation
and
Zai Lab (Shanghai) Co., Ltd
Dated as of November 8, 2021
TABLE OF CONTENTS
Page | ||||||
Article 1 DEFINITIONS |
1 | |||||
Article 2 LICENSES |
21 | |||||
2.1 |
License Grants to Zai | 21 | ||||
2.2 |
Sublicensing and Subcontractors | 22 | ||||
2.3 |
License Grants to Blueprint | 24 | ||||
2.4 |
Retained Rights | 24 | ||||
2.5 |
Combination Products Rights | 25 | ||||
2.6 |
Third Party In-Licenses | 25 | ||||
2.7 |
[****] | 27 | ||||
2.8 |
Exclusivity | 27 | ||||
Article 3 GOVERNANCE |
29 | |||||
3.1 |
Alliance Managers | 29 | ||||
3.2 |
Joint Steering Committee | 29 | ||||
3.3 |
Joint Project Teams | 32 | ||||
3.4 |
Working Groups | 34 | ||||
3.5 |
Non-Member Attendance | 34 | ||||
3.6 |
Decision-Making | 35 | ||||
3.7 |
Resolution of JSC Disputes | 35 | ||||
3.8 |
Discontinuation of JSC | 36 | ||||
Article 4 TECHNOLOGY TRANSFERS |
36 | |||||
4.1 |
Initial Know-How Transfer | 36 | ||||
4.2 |
Manufacturing Technology Transfer | 37 | ||||
4.3 |
Continuing Know-How Transfer | 38 | ||||
4.4 |
Conduct of Technology Transfer | 38 | ||||
4.5 |
Technology Transfer Costs | 38 | ||||
Article 5 DEVELOPMENT PROGRAM |
39 | |||||
5.1 |
Global Development Plan | 39 | ||||
5.2 |
Enrollment in Committed Trials | 39 | ||||
5.3 |
Zai Decision to Use a CRO | 40 | ||||
5.4 |
Territory-Specific Development Plans | 40 | ||||
5.5 |
Development Diligence | 40 | ||||
5.6 |
PRC Submission Estimated Timeline | 40 | ||||
5.7 |
Non-Clinical and Preclinical Studies | 41 |
-i-
5.8 |
Proposed Blueprint/Zai Combination Products | 41 | ||||
5.9 |
New Development Proposed by Zai | 43 | ||||
5.10 |
Standard of Conduct | 43 | ||||
5.11 |
New Development Proposed by Blueprint | 44 | ||||
5.12 |
Development of Co-Formulated Products | 44 | ||||
5.13 |
Responsibility for Development Costs | 45 | ||||
5.14 |
Clinical Trial Audit Rights | 45 | ||||
5.15 |
Development Records | 46 | ||||
5.16 |
Development Reports | 46 | ||||
5.17 |
Data Exchange and Use | 47 | ||||
5.18 |
Development of Companion Diagnostics | 47 | ||||
Article 6 REGULATORY |
48 | |||||
6.1 |
Regulatory Strategy | 48 | ||||
6.2 |
Zais Regulatory Responsibilities | 48 | ||||
6.3 |
Blueprints Regulatory Responsibilities | 50 | ||||
6.4 |
Right of Reference | 50 | ||||
6.5 |
Adverse Events Reporting | 51 | ||||
6.6 |
Regulatory Audits | 52 | ||||
6.7 |
No Harmful Actions | 52 | ||||
6.8 |
Notice of Regulatory Action | 53 | ||||
6.9 |
Notice of Other Actions | 53 | ||||
Article 7 MANUFACTURING |
53 | |||||
7.1 |
Supply by Blueprint | 53 | ||||
7.2 |
Supply by Zai | 54 | ||||
7.3 |
Product Tracking in the Territory | 55 | ||||
Article 8 |
56 | |||||
8.1 |
Medical Affairs Plans | 56 | ||||
8.2 |
Conduct of Medical Affairs Activities | 56 | ||||
8.3 |
Medical Affairs Reports | 56 | ||||
8.4 |
Coordination of Medical Affairs Activities | 56 | ||||
Article 9 COMMERCIALIZATION |
56 | |||||
9.1 |
Commercialization Diligence Obligations | 56 | ||||
9.2 |
Commercialization Plans | 57 | ||||
9.3 |
Conduct of Commercialization Activities | 57 | ||||
9.4 |
Commercialization Reports | 57 | ||||
9.5 |
Coordination of Commercialization Activities | 57 |
-ii-
9.6 |
Pricing; Reimbursement Approvals | 58 | ||||
9.7 |
Diversion | 58 | ||||
Article 10 PAYMENTS |
58 | |||||
10.1 |
Upfront Payment | 58 | ||||
10.2 |
Milestone Payments | 58 | ||||
10.3 |
Royalty Payments to Blueprint | 60 | ||||
10.4 |
Payments to Third Parties Under Existing Agreements | 62 | ||||
10.5 |
Other Amounts Payable | 62 | ||||
10.6 |
No Refunds | 62 | ||||
10.7 |
Accounting Standards | 62 | ||||
10.8 |
Currency; Exchange Rate | 62 | ||||
10.9 |
Blocked Payments | 63 | ||||
10.10 |
Late Payments | 63 | ||||
10.11 |
Financial Records and Audits | 63 | ||||
10.12 |
Taxes | 63 | ||||
10.13 |
VAT Credits | 64 | ||||
Article 11 CONFIDENTIALITY; PUBLICATION |
65 | |||||
11.1 |
Duty of Confidence | 65 | ||||
11.2 |
Confidential Information | 65 | ||||
11.3 |
Authorized Disclosures | 66 | ||||
11.4 |
Tax Treatment | 67 | ||||
11.5 |
Publications | 67 | ||||
11.6 |
Publication and Listing of Clinical Trials | 68 | ||||
11.7 |
Publicity; Use of Names | 68 | ||||
11.8 |
Attorney-Client Privilege | 69 | ||||
Article 12 REPRESENTATIONS, WARRANTIES, AND COVENANTS |
70 | |||||
12.1 |
Representations and Warranties of Each Party | 70 | ||||
12.2 |
Representations and Warranties of Blueprint | 71 | ||||
12.3 |
Representations and Warranties of Zai | 71 | ||||
12.4 |
Covenants of Zai | 72 | ||||
12.5 |
Mutual Covenants | 73 | ||||
12.6 |
Covenants of Blueprint | 74 | ||||
12.7 |
NO OTHER WARRANTIES | 75 | ||||
12.8 |
Time for Claims | 75 |
-iii-
Article 13 |
75 | |||||
INDEMNIFICATION |
75 | |||||
13.1 |
By Zai | 75 | ||||
13.2 |
By Blueprint | 76 | ||||
13.3 |
Indemnification Procedure | 76 | ||||
13.4 |
Insurance | 77 | ||||
Article 14 INTELLECTUAL PROPERTY |
77 | |||||
14.1 |
Inventions | 77 | ||||
14.2 |
Patent Prosecution | 80 | ||||
14.3 |
Patent Enforcement | 83 | ||||
14.4 |
Infringement of Third Party Rights | 84 | ||||
14.5 |
Patents Licensed from Third Parties | 85 | ||||
14.6 |
Patent Listings | 85 | ||||
14.7 |
Patent Term Extensions | 86 | ||||
14.8 |
Filing of Agreement with CNIPA | 87 | ||||
14.9 |
Product Trademarks | 87 | ||||
14.10 |
Patent Marking | 88 | ||||
Article 15 TERM AND TERMINATION |
88 | |||||
15.1 |
Term | 88 | ||||
15.2 |
Termination | 88 | ||||
15.3 |
Effect of Termination | 91 | ||||
15.4 |
Termination Press Releases | 95 | ||||
15.5 |
Survival | 95 | ||||
15.6 |
Termination Not Sole Remedy | 95 | ||||
Article 16 DISPUTE RESOLUTION |
96 | |||||
16.1 |
General | 96 | ||||
16.2 |
Negotiation; Escalation | 96 | ||||
16.3 |
Arbitration | 96 | ||||
Article 17 MISCELLANEOUS |
98 | |||||
17.1 |
Assignment | 98 | ||||
17.2 |
Limitation of Liability | 98 | ||||
17.3 |
Severability | 98 | ||||
17.4 |
Notices | 98 | ||||
17.5 |
Governing Law | 99 | ||||
17.6 |
Force Majeure | 99 | ||||
17.7 |
Entire Agreement; Amendments | 100 | ||||
17.8 |
Headings | 100 | ||||
17.9 |
Independent Contractors | 100 |
-iv-
17.10 |
Performance by Affiliates | 100 | ||||
17.11 |
Waiver | 100 | ||||
17.12 |
Waiver of Rule of Construction | 100 | ||||
17.13 |
Cumulative Remedies | 101 | ||||
17.14 |
Business Day Requirements | 101 | ||||
17.15 |
Further Actions | 101 | ||||
17.16 |
Non-Solicitation of Employees | 101 | ||||
17.17 |
Construction | 101 | ||||
17.18 |
Language; Translations | 102 | ||||
17.19 |
Counterparts | 102 |
Schedules
Schedule 1.17 [****]
Schedule 1.19 [****]
Schedule 1.32 Blueprint Patent Rights
Schedule 1.60 [****]
Schedule 1.197 Shared Services
Schedule 5.1 Global Development Plan
Schedule 7.1.1 Clinical Supply Agreement Terms
Schedule 7.1.2 Commercial Supply Agreement Terms
Schedule 11.7.1 Press Release
-v-
LICENSE AND COLLABORATION AGREEMENT
This LICENSE AND COLLABORATION AGREEMENT (this Agreement) is made as of November 8, 2021 (the Effective Date) by and between Blueprint Medicines Corporation, a Delaware corporation (Blueprint), having a place of business at 45 Sidney Street, Cambridge MA 02139, USA, and Zai Lab (Shanghai) Co., Ltd, an exempted company organized and existing under the laws of P.R. of China (Zai), having a place of business at 4F, Bldg 1, Jinchuang Plaza, 4560 Jinke Rd, Shanghai, China, 201210. Blueprint and Zai are referred to in this Agreement individually as a Party and collectively as the Parties.
RECITALS
WHEREAS, Blueprint is a biopharmaceutical company that is developing (a) a mutant EGFR inhibitor known as BLU-701, and (b) a mutant EGFR inhibitor known as BLU-945, in each case, that are being studied by Blueprint for the treatment of NSCLC and other cancers with certain mutations;
WHEREAS, Blueprint Controls certain Know-How and Patent Rights relating to BLU-945 and BLU-701;
WHEREAS, Zai is a biopharmaceutical company engaged in the research, development, and commercialization of pharmaceutical and biologic products in the Territory;
WHEREAS, Zai wishes to obtain from Blueprint an exclusive license to develop, perform medical affairs for, manufacture (subject to the terms in the Agreement) and commercialize, the Blueprint Compounds and Licensed Products, in each case, in the Territory, and Blueprint is willing to grant such a license to Zai, all in accordance with the terms and conditions set forth herein; and
WHEREAS, Blueprint and Zai both recognize the importance of accelerating Global Clinical Trials to address patient needs and Zai is willing to commit to participation in certain Clinical Trials as agreed to by both Parties for each Licensed Product.
AGREEMENT
NOW, THEREFORE, the Parties hereby agree as follows:
Article 1
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms will have the respective meanings set forth below, whether used in the singular or plural:
1.1 | Accounting Standards means GAAP for both Parties, unless a Party elects to change its general accounting principles to IFRS (or any change thereafter between IFRS and GAAP) and provides notice to the other Party of such change in accordance with Section 10.7 (Accounting Standards). |
1.2 | Acquiree has the meaning set forth in Section 2.8.3(b). |
1.3 | Acquiror has the meaning set forth in Section 2.8.3(a). |
1.4 | Active Ingredient means those clinically active materials that provide pharmacological activity in a pharmaceutical or biologic product (excluding [****]). |
1.5 | Affiliate means, with respect to a Person, any other Person that controls, is controlled by, or is under common control with such Person. For the purpose of this definition only, control (including, with correlative meaning, the terms controlled by and under the common control) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of any Person, whether by the ownership of more than 50% of the voting security of such Person, by contract, or otherwise. |
1.6 | Agreement has the meaning set forth in the Preamble. |
1.7 | Alliance Manager has the meaning set forth in Section 3.1 (Alliance Managers). |
1.8 | Anti-Corruption Laws has the meaning set forth in Section 12.1.5 (Representations and Warranties of Each Party). |
1.9 | Applicable Law means collectively all laws, rules, regulations, ordinances, decrees, judicial and administrative orders (and any license, franchise, permit, or similar right granted under any of the foregoing), and any policies and other requirements of any applicable Governmental Authority that govern or otherwise apply to a Party, including all Anti-Corruption Laws. |
1.10 | Approved Labeling means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product. |
1.11 | Arbitration Notice has the meaning set forth in Section 16.3.1 (Rules). |
1.12 | Arbitrators has the meaning set forth in Section 16.3.2 (Selection of Arbitrator). |
1.13 | Assigned Collaboration Know-How means any Collaboration Know-How that [****]. |
1.14 | Assigned Collaboration Patent Rights means all Collaboration Patent Rights that Cover Assigned Collaboration Know-How. |
1.15 | Assigned Collaboration Technology means the Assigned Collaboration Know-How and the Assigned Collaboration Patent Rights. |
1.16 | Average Patient Cost means with respect to additional patients enrolled in a Global Clinical Trial for a Licensed Product by a Party [****]. |
1.17 | BLU-701 means (a) Blueprints mutant [****] EGFR inhibitor known as BLU-701; (b) its named back-up forms [****] and any other backup form that Blueprint identifies and designates after the Effective Date as a back-up form for BLU-701 in accordance with Blueprints then-current business practices; (c) prodrugs that convert to the compounds in (a) and (b); (d) stereoisomers and isotopic variants of the compounds in (a), (b), and (c); (e) [****]; (f) salt forms of the compounds in (a) through (e); and (g) solvates, hydrates, and solid forms (including crystalline, polymorphic, amorphous and co-crystalline forms) of the compounds in (a) through (f). |
-2-
1.18 | [****] |
1.19 | BLU-945 means (a) Blueprints mutant [****] EGFR inhibitor known as BLU-945; (b) its named back-up forms [****] and any other backup form that Blueprint identifies and designates after the Effective Date as a back-up form for BLU-945 in accordance with Blueprints then-current business practices; (c) prodrugs that convert to the compounds in (a) and (b); (d) stereoisomers and isotopic variants of the compounds in (a), (b), and (c); (e) [****]; (f) salt forms of the compounds in (a) through (e); and (g) solvates, hydrates, and solid forms (including crystalline, polymorphic, amorphous and co-crystalline forms) of the compounds in (a) through (f). |
1.20 | [****] |
1.21 | Blueprint has the meaning set forth in the Preamble. |
1.22 | Blueprint Collaboration Know-How means Collaboration Know-How, other than Blueprint/Zai Combination Know-How, developed or invented solely by Blueprints or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How (or Patent Rights Covering such Know-How) to Blueprint or any Affiliate of Blueprint, in each case, in the performance of activities under this Agreement during the Term. |
1.23 | Blueprint Collaboration Patent Rights means all Collaboration Patent Rights that Cover Blueprint Collaboration Know-How. |
1.24 | Blueprint Compound means BLU-701 or BLU-945 and includes [****]. |
1.25 | Blueprint Identified Rights has the meaning set forth in Section 2.6.1 (Blueprint Identified Rights). |
1.26 | Blueprint Indemnitee(s) has the meaning set forth in Section 13.1 (By Zai). |
1.27 | Blueprint In-Licensed Rights has the meaning set forth in Section 2.6.3 (Third Party IP Agreements). |
1.28 | Blueprint Know-How means, subject to Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), all Know-How (excluding Blueprints interest in the Blueprint/Zai Combination Know-How and other Joint Collaboration Know-How) that is (a) Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term, and (b) necessary or reasonably useful to Develop, perform Medical Affairs for, or Commercialize a Blueprint Compound or a Licensed Product in the Territory, including all Assigned Collaboration Know-How and Blueprint Collaboration Know-How, but expressly excluding Blueprint Manufacturing Know-How. |
1.29 | Blueprint Manufacturing Know-How means all Know-How Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term that is actually used for the Manufacture of each Licensed Product in the Field in the Territory. |
1.30 | Blueprint Manufacturing Patent Rights means all Patent Rights Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term that are actually practiced for the Manufacture of each Licensed Product in the Field in the Territory. |
1.31 | Blueprint Manufacturing Technology means the Blueprint Manufacturing Know-How and the Blueprint Manufacturing Patent Rights. |
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1.32 | Blueprint Patent Rights means, subject to Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), all Patent Rights (excluding Blueprints interest in the Blueprint/Zai Combination Patent Rights and other Joint Collaboration Patent Rights) that are (a) Controlled by Blueprint or any of its Affiliates as of the Effective Date or during the Term, and (b) necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to Develop, perform Medical Affairs for, or Commercialize a Blueprint Compound or a Licensed Product in the Territory, including all Assigned Collaboration Patent Rights and Blueprint Collaboration Patent Rights, but expressly excluding Blueprint Manufacturing Patent Rights. Schedule 1.32 (Blueprint Patent Rights) includes the Blueprint Patent Rights that are owned or exclusively licensed by Blueprint in the Territory and that exist as of the Effective Date. |
1.33 | Blueprint Publication has the meaning set forth in Section 11.5.1. |
1.34 | Blueprint Specifications has the meaning set forth in Section 7.2.3 (Specifications). |
1.35 | Blueprint Technology means Blueprint Know-How, Blueprint Patent Rights, and Blueprints interest in the Joint Collaboration Technology. |
1.36 | Blueprint/Zai Combination means any Combination Product or Combination Regimen that includes a Blueprint Compound together with any Zai Product. |
1.37 | Blueprint/Zai Combination Know-How means any Collaboration Know-How that (a) [****] relates to any Blueprint/Zai Combination (and not to any Zai Product alone or any other Licensed Product that is not a Blueprint/Zai Combination), including any composition, method of use or method of Manufacturing, in each case, that is specific to a Blueprint/Zai Combination (including any composition, method of use, or method of Manufacturing that is [****]), or any Companion Diagnostic [****] for use with a Blueprint/Zai Combination, and (b) is developed or invented during the Term by a Partys or its Affiliates, licensees, Sublicensees, or Sublicensees employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or Patent Rights Covering such Know-How) to a Party or any Affiliate of a Party, either alone or jointly with the other Partys or its Affiliates, licensees, Sublicensees, Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or Patent Rights Covering such Know-How) to the other Party or any Affiliate of the other Party, in each case, in the performance of activities under this Agreement during the Term. |
1.38 | Blueprint/Zai Combination Patent Rights means all Collaboration Patent Rights that Cover Blueprint/Zai Combination Know-How. For clarity, Blueprint/Zai Combination Patent Rights do not include any Patent Rights that Cover (a) a Zai Product alone or (b) any other Licensed Product that is not a Blueprint/Zai Combination or a Companion Diagnostic that is for use with a Zai Product alone or any other Licensed Product that is not a Blueprint/Zai Combination. |
1.39 | Blueprint/Zai Combination Technology means the Blueprint/Zai Combination Know-How and the Blueprint/Zai Combination Patent Rights. |
1.40 | Breach Notification has the meaning set forth in Section 15.2.2(a) (Notice and Cure Period). |
1.41 | Business Day means a day other than a Saturday, Sunday, or a day on which banking institutions in Cambridge, Massachusetts or Shanghai, China are required by Applicable Law to remain closed. |
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1.42 | Buyers has the meaning set forth in Section 1.136 (Net Sales). |
1.43 | Calendar Quarter means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30, and December 31. |
1.44 | Calendar Year means each 12-month period commencing on January 1. |
1.45 | cGMP means all applicable current Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonizations Q7 guidelines, and (d) the equivalent Applicable Law in any relevant country or region, each as may be amended and applicable from time to time. |
1.46 | Change of Control means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing at least 50% of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated that would result in shareholders or equity holders of such Party that owned less than 50% of the outstanding voting securities of such Party immediately prior to such transaction, owning at least 50% of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) there is a sale or transfer to a Third Party of all or substantially all of such Partys consolidated assets taken as a whole, through one or more related transactions. |
1.47 | Clinical Development means, with respect to a pharmaceutical or biologic product, Development activities conducted from and after (and including) the filing of an IND for such pharmaceutical or biologic product specifically in connection with (a) Clinical Trials and (b) regulatory activities related to Clinical Trials, including filing of MAAs and obtaining, supporting, or maintaining Regulatory Approvals for such pharmaceutical or biologic product following completion of a Pivotal Trial for such pharmaceutical or biologic product. |
1.48 | Clinical Supply Agreement has the meaning set forth in Section 7.1.1 (Development Supply). |
1.49 | Clinical Trial means any clinical trial in humans that is conducted in accordance with GCP and is designed to generate data in support or maintenance of an IND or MAA, or other similar marketing application, including any Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, or any post-approval clinical trial in humans. |
1.50 | CMO means a contract manufacturing organization. |
1.51 | Collaboration Know-How means any Know-How developed or invented during the Term by a Partys or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How to a Party or any Affiliate of a Party, either alone or jointly with the other Partys or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Know-How (or patent Rights Covering such Know-How) to the other Party or any Affiliate of the other Party, in each case, in the performance of activities under this Agreement during the Term. |
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1.52 | Collaboration Patent Rights means any Patent Rights that (a) (i) claim any Invention included in the Collaboration Know-How or (ii) disclose any Collaboration Know-How and (b) have a priority date that is after the Effective Date. |
1.53 | Collaboration Technology means Collaboration Know-How and Collaboration Patent Rights. |
1.54 | Combination Product means a Licensed Product that includes (a) BLU-701 or BLU-945, or both, on the one hand; and (b) another Active Ingredient, on the other hand, sold for a single price. |
1.55 | Combination Regimen means any product or treatment regimen that comprises, or is a combination of (a) a Licensed Product containing a Blueprint Compound, and (b) any other product containing an Active Ingredient other than such Blueprint Compound, where (a) and (b) are labeled for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price. |
1.56 | Commercial Supply Agreement has the meaning set forth in Section 7.1.2 (Commercial Supply). |
1.57 | Commercialization means any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of a pharmaceutical or biologic product and interacting with Regulatory Authorities following receipt of Regulatory Approval in the applicable country or region for such pharmaceutical or biologic product regarding the foregoing, including seeking and maintaining any required Reimbursement Approval, but excluding activities directed to Manufacturing, Development, or Medical Affairs. Commercialize, Commercializing, and Commercialized will be construed accordingly. |
1.58 | Commercialization Plan means, with respect to a Licensed Product, the written [****] strategic and tactical plans for the Commercialization activities for such Licensed Product to be conducted in the Territory that will be prepared and updated by Zai as provided in Section 9.2 (Commercialization Plans). |
1.59 | Commercially Reasonable Efforts means, with respect to the Exploitation of a Blueprint Compound or a Licensed Product by a Party, those efforts and resources, including reasonably necessary personnel, equivalent to the efforts that a reasonable international biopharmaceutical company or a pharmaceutical company[****] based on conditions then prevailing and taking into account all relevant factors [****]. Commercially Reasonable Efforts requires, with respect to an obligation, that the Party: (a) promptly assign responsibility for such obligation to specific employees who are held accountable for progress and monitor such progress on an on-going basis, (b) set and seek to achieve specific and meaningful objectives for carrying out such obligation, and (c) make and implement decisions and allocate resources designed to advance progress with respect to such objectives. [****] |
1.60 | [****] |
1.61 | Companion Diagnostics has the meaning set forth in Section 5.18 (Development of Companion Diagnostics). |
1.62 | Competitive Activities has the meaning set forth in Section 2.8.1 (Exclusivity Covenant). |
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1.63 | Competitive Product means [****] other than a Licensed Product, that [****]. |
1.64 | Confidential Information means (a) Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property, and other non-public or proprietary data or information (including unpublished patent applications) that may be disclosed by one Party or its Affiliates to the other Party or its Affiliates pursuant to this Agreement (including information disclosed prior to the Effective Date pursuant to the Confidentiality Agreement), regardless of whether such information is specifically marked or designated as confidential and regardless of whether such information is in written, oral, electronic, or other form, and (b) the terms of this Agreement. Information of a Disclosing Party will not be Confidential Information of such Disclosing Party to the extent that the Receiving Party can demonstrate through competent evidence that such information: |
(a) | is known by the Receiving Party or any of its Affiliates without an obligation of confidentiality at the time of its receipt from the Disclosing Party, and not through a prior disclosure by or on behalf of the Disclosing Party, as documented by the Receiving Partys business records; |
(b) | is generally available to the public before its receipt from the Disclosing Party; |
(c) | became generally available to the public or otherwise part of the public domain after its disclosure by the Disclosing Party and other than through any act or omission of the Receiving Party or any of its Affiliates or discloses in breach of this Agreement; |
(d) | is subsequently disclosed to the Receiving Party or any of its Affiliates without obligation of confidentiality by a Third Party who may rightfully do so and is not under a conflicting obligation of confidentiality to the Disclosing Party; or |
(e) | is developed by the Receiving Party or any of its Affiliates independently and without use of or reference to any Confidential Information received from the Disclosing Party, as documented by the Receiving Partys business records. |
No combination of features or disclosures will be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
1.65 | Confidentiality Agreement means the Confidential Disclosure Agreement dated [****] by and between the Parties. |
1.66 | Continuing Know-How Transfer has the meaning set forth in Section 4.3 (Continuing Know-How Transfer). |
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1.67 | Control or Controlled means the possession by a Party (whether by ownership, license, or otherwise other than pursuant to this Agreement) of, (a) with respect to any tangible Know-How, the legal authority or right to physical possession of such tangible Know-How, with the right to provide such tangible Know-How to the other Party on the terms set forth herein, or (b) with respect to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights, the legal authority or right to grant a license, sublicense, access, or right to reference or use (as applicable) to the other Party under such Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible Know-How, or other intellectual property rights on the terms set forth herein, in each case ((a) and (b)), without breaching or otherwise violating the terms of any arrangement or agreement with a Third Party in existence as of the time such Party or its Affiliates would first be required hereunder to grant the other Party such access, right to use, licenses, or sublicense and without being required to make any payment to any Third Party other than payment obligations related to Blueprint In-Licensed Rights or Zai In-Licensed Rights acquired or licensed in accordance with Section 2.6 (Third Party In-Licenses) under which the other Party elects to take a sublicense and agrees to reimburse the contracting Party as set forth in Section 2.6 (Third Party In-Licenses). Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to Control any Patent Right or Know-How that, prior to the consummation of a Change of Control of such Party, is owned or in-licensed by a Third Party that becomes an Affiliate of such acquired Party after the Effective Date as a result of such Change of Control unless (i) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Patent Right or Know-How, or (ii) after the consummation of such Change of Control, such acquired Party or any of its Affiliates determines to use or uses any such Patent Rights or Know-How in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases ((i) and (ii)), such Patent Rights or Know-How will be Controlled by such Party for purposes of this Agreement. |
1.68 | Controlling Party has the meaning set forth in Section 14.3.2(a)(ii) (Enforcement Rights; Zai First Right). |
1.69 | Cover means, with respect to a particular subject matter at issue and a relevant Patent Right, that the manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of a claim in such Patent Right. |
1.70 | [****] |
1.71 | CRO means a contract research organization. |
1.72 | Data Breach has the meaning set forth in Section 12.5.2. |
1.73 | Debarred/Excluded means any Person becoming debarred or suspended under 21 U.S.C. §335(a) or (b), the subject of a conviction described in Section 306 of the FD&C Act, excluded, or having previously been excluded, from a federal or governmental health care program, debarred from federal contracting, convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud, the subject to OFAC sanctions or on the OFAC list of specially designated nationals, or the subject of any similar sanction of any Governmental Authority in the Territory. |
1.74 | Deficient Site has the meaning set forth in Section 5.14.2 (Deficient Sublicensees or Sites and Replacement). |
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1.75 | Development means all internal and external research, development, and regulatory activities related to pharmaceutical or biologic products, including (a) research, non-clinical testing, toxicology, testing and studies, non-clinical and preclinical activities, and Clinical Trials, (b) preparation, submission, review, and development of data or information (or reports relating thereto and analysis and review of such reports) for the purpose of reviewing the progress and status of the activities under subsection (a) or for the purposes of submission to a Regulatory Authority to obtain authorization to conduct Clinical Trials and to obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic product, but excluding activities directed to Manufacturing, Medical Affairs, or Commercialization, and (c) the design of future studies, non-clinical and preclinical activities, and Clinical Trials. Development will include development and regulatory activities for additional forms, formulations, or indications for a pharmaceutical or biologic product after receipt of Regulatory Approval of such product (including label expansion), including Clinical Trials initiated following receipt of Regulatory Approval or any Clinical Trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval with respect to an approved formulation or Indication (such as post-marketing studies, observational studies, implementation and management of registries and analysis thereof, in each case, if required by any Regulatory Authority in any region in the Territory to support or maintain Regulatory Approval for a pharmaceutical or biologic product in such region). Develop, Developing, and Developed will be construed accordingly. |
1.76 | Development Milestone Events has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments). |
1.77 | Development Milestone Payments has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments). |
1.78 | Development Subcontractor has the meaning set forth in Section 2.2.3 (Right to Subcontract). |
1.79 | Disclosing Party has the meaning set forth in Section 11.1.1 (Duty of Confidence). |
1.80 | Dispute has the meaning set forth in Section 16.1 (General). |
1.81 | Dollar means the U.S. dollar, and $ will be interpreted accordingly. |
1.82 | Effective Date has the meaning set forth in the Preamble. |
1.83 | EGFR means epidermal growth factor receptor. |
1.84 | Examined Party has the meaning set forth in Section 10.11 (Financial Records and Audits). |
1.85 | Excess Enrollment Reimbursement has the meaning set forth in Section 5.2.3 (Enrollment of Additional Patients). |
1.86 | Executive Officers has the meaning set forth in Section 3.6.3 (Decisions of the JSC). |
1.87 | Exploit means to make, have made, use, offer to sell, sell, import, export, Develop, Manufacture, perform Medical Affairs activities, or Commercialize. Exploitation will be construed accordingly. |
1.88 | FD&C Act means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.89 | FDA means the United States Food and Drug Administration or any successor entity thereto having essentially the same function. |
1.90 | Field means the prevention, treatment, and diagnosis of any indications in humans. |
1.91 | First Commercial Sale means, with respect to any Licensed Product in any country or region, the first sale of such Licensed Product to a Third Party for distribution, use, or consumption in such country or region after receiving all necessary Regulatory Approval and Reimbursement Approval (if required) to do so. First Commercial Sale excludes [****]. |
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1.92 | FTE means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [****] per year) carrying out Development, Manufacturing, Medical Affairs activities, or other scientific or technical work under this Agreement. Overtime and work on weekends, holidays, and the like, in each case, will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. The portion of an FTE billable by a Party for one individual during a given accounting period will be determined by dividing the number of hours worked directly by such individual on the work to be conducted under this Agreement during such accounting period and the number of FTE hours applicable for such accounting period based on [****] per Calendar Year. |
1.93 | FTE Rate means the amount for an FTE per Calendar Year, which for the Calendar Year ending on December 31, 2021 will be [****]. |
1.94 | Fully Burdened Manufacturing Cost means, with respect to any Blueprint Compound, Licensed Product, or any Zai Product (or component thereof), in each case, supplied by or on behalf of the applicable Party to the other Party or its Affiliates hereunder: |
(a) | if and to the extent such Blueprint Compound, Licensed Product, or Zai Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Third Party manufacturer, (i) the actual Third Party costs of such Manufacturing incurred by the supplying Party, including the costs [****]; and |
(b) | if and to the extent such Blueprint Compound, Licensed Product, or Zai Product (or any precursor or intermediate thereof), as applicable, is Manufactured by a Party or its Affiliate, the actual, fully burdened costs [****], including the cost of [****] Such fully burdened costs will be calculated in accordance with applicable Accounting Standards, consistently applied. |
1.95 | GAAP means United States generally accepted accounting principles, consistently applied. |
1.96 | GCP means all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) (the ICH Guidelines) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Law in the region in the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects. |
1.97 | [****] |
1.98 | Global Brand Elements has the meaning set forth in Section 14.9.1 (Global Brand Elements). |
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1.99 | Global Brand Strategy has the meaning set forth in Section 9.2 (Commercialization Plan). |
1.100 | Global Clinical Trial means a Clinical Trial for a Licensed Product the data from which, at the time of commencement, is intended to be used to obtain Regulatory Approval both inside the Territory and in any of the following: [****]. |
1.101 | Global Development Plan has the meaning set forth in Section 5.1 (Global Development Plan). |
1.102 | GLP means all applicable good laboratory practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration, as defined in 21 C.F.R. Part 58, and the equivalent Applicable Law in the region in the Territory, each as may be amended and applicable from time to time. |
1.103 | Governmental Authority means any federal, national, state, provincial, or local government, or political subdivision thereof, or any multinational organization or any authority, agency, regulatory body, or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, or any court or tribunal (or any department, bureau or division of any of the foregoing, or any governmental arbitrator or arbitral body). Governmental Authorities include all Regulatory Authorities. |
1.104 | [****] |
1.105 | ICC has the meaning set forth in Section 16.3.1 (Rules). |
1.106 | ICH Guidelines has the meaning set forth in Section 1.96 (GCP). |
1.107 | IDL has the meaning set forth in Section 1.131 (Marketing Authorization Application or MAA). |
1.108 | IFRS means International Financial Reporting Standards, consistently applied. |
1.109 | IND means an Investigational New Drug application required pursuant to 21 C.F.R. Part 312 or any comparable filings outside of the U.S. required to commence human clinical trials in such country or region (such as an application for a Clinical Trial Authorization in the Territory), and all supplements or amendments that may be filed with respect to the foregoing. |
1.110 | Indemnified Party has the meaning set forth in Section 13.3 (Indemnification Procedure). |
1.111 | Indemnifying Party has the meaning set forth in Section 13.3 (Indemnification Procedure). |
1.112 | Indication means [****] that a Licensed Product is [****] in the indication section of the Approved Labeling for such Licensed Product, or that is the subject of a Clinical Trial and where it is [****] |
1.113 | Initial Know-How Transfer has the meaning set forth in Section 4.1 (Initial Know-How Transfer). |
1.114 | Invention means any process, method, composition, article of manufacture, discovery, or finding that is conceived or reduced to practice (whether or not patentable). |
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1.115 | Joint Collaboration Know-How means (a) Blueprint/Zai Combination Know-How, and (b) other Collaboration Know-How, excluding any Assigned Collaboration Know-How, developed or invented jointly by a Partys or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the one hand, and the other Partys or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How to such Party or any Affiliate of such Party, on the other hand, in the performance of activities under this Agreement during the Term. |
1.116 | Joint Collaboration Patent Rights means all Collaboration Patent Rights that Cover Joint Collaboration Know-How, including Blueprint/Zai Combination Patent Rights. |
1.117 | Joint Collaboration Technology means the Joint Collaboration Know-How and the Joint Collaboration Patent Rights. |
1.118 | JPT has the meaning set forth in Section 3.3 (Joint Project Teams). |
1.119 | JPT Chairperson has the meaning set forth in Section 3.3.1 (Formation; Composition; Meetings). |
1.120 | JSC has the meaning set forth in Section 3.2.1 (Formation). |
1.121 | JSC Chairperson has the meaning set forth in Section 3.2.1 (Formation). |
1.122 | Know-How means any information and materials, including records, discoveries, improvements, modifications, processes, techniques, methods, assays, chemical or biological materials, designs, protocols, formulas, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, and analytical and quality control data), dosage regimens, control assays, product specifications, marketing, pricing and distribution costs, Inventions, algorithms, technology, forecasts, profiles, strategies, plans, results in any form whatsoever, know-how and trade secrets (in each case, whether or not patentable, copyrightable or otherwise). |
1.123 | Knowledge means [****] of (a) with respect to Blueprint, [****] and (b) with respect to Zai, [****]. |
1.124 | Licensed Product means any product containing a Blueprint Compound as an Active Ingredient, in any form, formulation, dosage form, or method of delivery[****]. [****] |
1.125 | Listing Patents has the meaning set forth in Section 14.6 (Patent Listings). |
1.126 | Local Manufacturing Approval means receipt of all approvals and authorizations necessary for Zai or its Affiliate or their respective CMOs to Manufacture a particular Licensed Product in a particular region in the Territory (including after validation and qualification of Zais or such Affiliates or CMOs applicable facilities in the Territory). |
1.127 | Losses means damages, debts, obligations, and other liabilities, losses, claims, taxes, interest obligations, deficiencies, judgments, assessments, fines, fees, penalties, or expenses (including amounts paid in settlement, interest, court costs, costs of investigators, reasonable fees and expenses of attorneys, accountants, financial advisors, consultants, and other experts, and other expenses of litigation). |
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1.128 | Manufacture means activities directed to manufacturing, processing, packaging, labeling, filling, finishing, assembly, shipping, storage, or freight of any pharmaceutical or biologic product (or any components or process steps involving any product or any companion diagnostic), placebo, or comparator agent, as the case may be, including quality assurance and stability testing, characterization testing, quality control release testing of drug substance and drug product, quality assurance batch record review and release of product, process development, qualification, and validation, scale-up, pre-clinical, clinical, and commercial manufacture and analytic development, and product characterization, but excluding activities directed to Development, Commercialization, or Medical Affairs. Manufacturing and Manufactured will be construed accordingly. |
1.129 | Manufacturing Technology Transfer means the transfer of the Blueprint Manufacturing Know-How related to a Blueprint Compound and Licensed Products containing such Blueprint Compound in accordance with the Manufacturing Technology Transfer Plan for such Blueprint Compound, which includes the provision of any technical assistance to enable the Manufacture of such Licensed Products [****]. |
1.130 | Manufacturing Technology Transfer Plan means, for each Blueprint Compound, the plan for the transfer to Zai and its designees of Blueprint Manufacturing Know-How for the Licensed Products that include such Blueprint Compound, which plan, among other things, will set forth [****]. |
1.131 | Marketing Authorization Application or MAA means any new drug application, biologics license application, or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction, which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction (and any amendments thereto). In the context of imported drugs, MAA is also known as the Import Drug License (IDL) application. |
1.132 | Medical Affairs means activities conducted by a Partys medical affairs departments (or, if a Party does not have a medical affairs department, the equivalent function thereof), including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), activities performed in connection with patient registries, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Licensed Products and are not conducted by a Partys medical affairs (or equivalent) departments. |
1.133 | Medical Affairs Plan means, with respect to a Licensed Product, [****] for the Medical Affairs activities for such Licensed Product to be conducted in the Territory, which plan will include medical information that Zai will provide in the Territory, including [****] that will be prepared and updated by Zai as provided in Section 8.1 (Medical Affairs Plans). |
1.134 | Milestone Events has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events). |
1.135 | Milestone Payments has the meaning set forth in Section 10.2.3(a) (Notification of Milestone Events). |
1.136 | Net Sales means with respect to a Licensed Product, the gross amount [****] by Zai and its Affiliates and Sublicensees (each of the foregoing, a Seller) to independent, unrelated persons (including Third Party Distributors) (Buyers) in bona fide arms length transactions with respect to such Licensed Product, less the following deductions, in each case, to the extent [****] in connection with such Licensed Product: |
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(a) | [****] |
(b) | [****] |
(c) | [****] |
(d) | [****] |
(e) | [****] |
(f) | [****]. |
If Seller receives non-cash consideration for a Licensed Product sold to a Buyer during the Term, then the Net Sales amount for such Licensed Product will be calculated based on [****].
No deduction will be made for any item of cost incurred by any Seller in Developing or Commercializing Licensed Products except as permitted pursuant to clauses (a) to (f) of the foregoing sentence; provided that Licensed Products transferred to Buyers in reasonable quantities in connection with Clinical Trials, compassionate use or named-patient use, in each case, will give rise to Net Sales only to the extent [****]. If a single item falls into more than one of the categories set forth in clauses (a)-(f) above, then such item may not be deducted more than once.
All deductions in clauses (a) through (f) above will be fairly and equitably allocated between such Licensed Product and other products of Zai and its Affiliates and Sublicensees such that such Licensed Product does not bear a disproportionate portion of such deductions. Calculations of Net Sales will be consistently applied across all products of Seller and will be consistent between periods.
Such amounts will be determined from the books and records of Seller, and will be calculated in accordance with applicable Accounting Standards.
Transfers or sales between Zai and its Affiliates and Sublicensees will be disregarded for purposes of calculating Net Sales, except if such purchaser is an end user.
[****]
If a Licensed Product is a Combination Product, [****].
If a Licensed Product containing the Blueprint Compound as the sole Active Ingredient is sold as part of an Combination Product and is sold separately in finished form, but the other Active Ingredients included in the Combination Product are not sold separately in finished form, [****].
If a Licensed Product containing the Blueprint Compound as the sole Active Ingredient is sold as part of a Combination Product and is not sold separately in finished form, but the other Active Ingredients included in the Combination Product are sold separately in finished form, [****].
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If Net Sales of the Licensed Product when included in an Combination Product cannot be determined using the methods above (as neither the Licensed Product containing the applicable Blueprint Compound as the sole Active Ingredient nor the other Active Ingredients are sold separately), [****]. At least [****] prior to the anticipated First Commercial Sale of any such Combination Product in a region in the Territory, Zai will propose such good faith estimate to Blueprint, and Blueprint will [****] consider such proposal, and the Parties will seek to reach agreement on such allocation. If the Parties are unable to reach such agreement within [****] after Zai provides such proposal, then the issue will be resolved in accordance with Article 16 (Dispute Resolution).
1.137 | New Affiliate has the meaning set forth in Section 2.8.3 (New Affiliate Exception). |
1.138 | New Combination has the meaning set forth in Section 5.9 (New Development Proposed by Zai). |
1.139 | New Development Activities has the meaning set forth in Section 5.9 (New Development Proposed by Zai). |
1.140 | New Development Proposal has the meaning set forth in Section 5.9 (New Development Proposed by Zai). |
1.141 | New Indication has the meaning set forth in Section 5.9 (New Development Proposed by Zai). |
1.142 | [****] |
1.143 | New Territory-Specific Development Activities has the meaning set forth in Section 5.9.1(a) (JSC Approval). |
1.144 | NMPA means the National Medical Products Administration of the PRC, and local counterparts thereto, and any successor agency or authority thereto having substantially the same function. |
1.145 | Non-Clinical Development means all Development excluding Clinical Development. |
1.146 | Non-Funding Party has the meaning set forth in Section 5.8.1(a) (JSC Approval). |
1.147 | NSCLC means non-small cell lung cancer. |
1.148 | OFAC means the Office of Foreign Assets Control of the United States Department of the Treasury or any successor agency thereto. |
1.149 | Other Extensions has the meaning set forth in Section 14.7 (Patent Term Extensions). |
1.150 | Party or Parties has the meaning set forth in the Preamble. |
1.151 | Patent Challenge has the meaning set forth in Section 15.2.3 (Termination for Patent Challenge). |
1.152 | Patent Prosecution means activities directed to (a) preparing, filing, or prosecuting applications (of all types) for any Patent Right, (b) maintaining any Patent Right, or (c) deciding whether to abandon or maintain any Patent Right. |
1.153 | Patent Rights means (a) all patents and patent applications in any country or region, (b) all patent applications filed either from such patents or patent applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications, and (d) any and all substitutions, renewals, registrations, confirmations, extensions, or restorations, including revalidations, reissues, and re-examinations (including any supplementary protection certificates and the like) of the foregoing patents or patent applications. |
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1.154 | Patent Term Adjustment has the meaning set forth in Section 14.7 (Patent Term Extensions). |
1.155 | Patent Term Extension has the meaning set forth in Section 14.7 (Patent Term Extensions). |
1.156 | Patient Commitment has the meaning set forth in Section 5.2.1 (Enrollment in Committed Trials). |
1.157 | Paying Party has the meaning set forth in Section 10.12.2 (Tax Cooperation). |
1.158 | Permitted Zai Non-Clinical Development has the meaning set forth in Section 5.7 (Non-Clinical and Preclinical Studies). |
1.159 | Person means any corporation, limited or general partnership, limited liability company, joint venture, joint stock company, trust, unincorporated association, governmental body, authority, bureau, or agency, or any other entity or body, or an individual. |
1.160 | Personal Information means information related to a reasonably identifiable natural person. |
1.161 | Phase I Clinical Trial means a clinical trial in humans that is generally consistent with 21 C.F.R. § 312.21(a), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region. |
1.162 | Phase II Clinical Trial means a clinical trial in humans that is generally consistent with 21 C.F.R. § 312.21(b), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region. |
1.163 | Phase III Clinical Trial means a clinical trial in humans of a pharmaceutical or biologic product (including any Combination Regimen) that is generally consistent with 21 C.F.R. § 312.21(c), as amended (or its successor regulation), or, with respect to any other country or region, the equivalent of such a clinical trial in such other country or region. |
1.164 | Pivotal Trial means any (a) [****] or (b) [****] in humans of a pharmaceutical or biologic product (including any Combination Regimen), the results of which, together with prior data and information concerning such product, are [****] in any particular jurisdiction and that is intended to support, or otherwise supports, the filing of an MAA in such jurisdiction (including any bridging study). |
1.165 | POC Trial means a clinical trial [****] in humans of a pharmaceutical or biologic product (including any Combination Regimen) performed to [****] of such product and that [****]. |
1.166 | PRC means the Peoples Republic of China, which, for purposes of this Agreement, does not include Hong Kong Special Administrative Region, Macau Special Administrative Region, or Taiwan. |
1.167 | PRC Submission Estimated Timeline means, for each Licensed Product, a written timeline setting forth the estimated dates of achievement of key regulatory milestones and submission to applicable Regulatory Authorities in the PRC of key Regulatory Submissions (including each MAA) for such Licensed Product. |
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1.168 | Preapproved Subcontractor means any Subcontractor that the JSC has approved as a Subcontractor that Zai may engage to perform its obligations or exercise its rights under this Agreement as further described in Section 2.2.3 (Right to Subcontract). |
1.169 | Privacy Laws has the meaning set forth in Section 12.5.2. |
1.170 | Product Infringement has the meaning set forth in Section 14.3.1 (Patent Enforcement; Notice). |
1.171 | Product Marks has the meaning set forth in Section 14.9.1 (Global Brand Elements). |
1.172 | Proposed Blueprint/Zai Combination has the meaning set forth in Section 5.8.1 (Proposed Blueprint/Zai Combinations). |
1.173 | Prosecuting Party has the meaning set forth under Section 14.2.3(a) (Blueprint/Zai Combination Technology). |
1.174 | Public Official means (a) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (b) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary, laboratory or medical facility; (c) any officer, employee or representative of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank; and (d) any person acting in an official capacity for any government or government entity, enterprise, or organization identified above. |
1.175 | Publication has the meaning set forth in Section 11.5 (Publications). |
1.176 | Receiving Party has the meaning set forth in Section 11.1.1 (Duty of Confidence). |
1.177 | Recipient has the meaning set forth in Section 10.12.2 (Tax Cooperation). |
1.178 | Regulatory Approval means, with respect to a particular country or other regulatory jurisdiction, any approval of an MAA or other approval, product, or establishment license, registration, permit, or authorization of any Regulatory Authority necessary for the commercial marketing or sale of a pharmaceutical or biologic product in such country or other regulatory jurisdiction, excluding, in each case, Reimbursement Approval. |
1.179 | Regulatory Authority means any applicable Governmental Authority with jurisdiction or authority over the Development, Manufacture, Commercialization, or other Exploitation (including Regulatory Approval or Reimbursement Approval) of pharmaceutical or biologic products in a particular country or other regulatory jurisdiction, including the NMPA, and any corresponding national or regional regulatory authorities. |
1.180 | Regulatory Exclusivity means any exclusive marketing rights or data protection or other exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical or biologic product in a particular country or other regulatory jurisdiction that prohibits a Person from Commercializing [****]. |
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1.181 | [****] |
1.182 | Regulatory Submissions means any filing, application, or submission with any Regulatory Authority in support of Developing, Manufacturing, or Commercializing a pharmaceutical or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, MAAs, and other applications for Regulatory Approval and their equivalents. |
1.183 | Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory. |
1.184 | Replacement Site has the meaning set forth in Section 5.14.2 (Deficient Sublicensees or Sites and Replacement). |
1.185 | Review Period has the meaning set forth in Section 11.5 (Publications). |
1.186 | Royalty Estimate has the meaning set forth in Section 10.3.4 (Royalty Reports and Payments). |
1.187 | Royalty Patent Rights means the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, and the Joint Collaboration Patent Rights. |
1.188 | Royalty Payments has the meaning set forth in Section 10.3.1 (Royalty Rates). |
1.189 | Royalty Report has the meaning set forth in Section 10.3.4 (Royalty Reports and Payments). |
1.190 | Royalty Term has the meaning set forth in Section 10.3.2 (Royalty Term). |
1.191 | Rules has the meaning set forth in Section 16.3.1 (Arbitration; Rules). |
1.192 | Safety Agreement has the meaning set forth in Section 6.5.1 (Adverse Events Reporting; Safety Agreements). |
1.193 | Sales Milestone Events has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments). |
1.194 | Sales Milestone Payments has the meaning set forth in Section 10.2.2 (Sales Milestone Events and Payments). |
1.195 | Scientific Officers has the meaning set forth in Section 2.8.2 (Competitive Product Disputes). |
1.196 | Seller has the meaning set forth in Section 1.136 (Net Sales). |
1.197 | Shared Services Costs means [****] 1.197 [****]. |
1.198 | [****] has the meaning set forth in Section 5.2.2 [****]. |
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1.199 | Subcontractor means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement on a fee-for-service basis (including CROs and CMOs). |
1.200 | Sublicensee means any Person, excluding any Subcontractor or Third Party Distributor, (a) with respect to Zai, to whom Zai grants a sublicense of, or other authorization or permission granted under, the rights granted to Zai in Section 2.1 (License Grants to Zai), and (b) with respect to Blueprint, to whom Blueprint grants a sublicense of, or other authorization or permission granted under, the rights granted to Blueprint in Section 2.3 (License Grants to Blueprint). |
1.201 | Tax or Taxes means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon), including value add taxes (VAT). |
1.202 | Technology Transfer has the meaning set forth in Section 4.3 (Continuing Know-How Transfer). |
1.203 | Term has the meaning set forth in Section 15.1 (Term). |
1.204 | Territory means the PRC, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan, each of which will be deemed a separate region for purposes of this Agreement. |
1.205 | Territory Sponsor means, with respect to a Territory-Specific Clinical Trial or a Global Clinical Trial for a Licensed Product to be conducted at sites in the Territory, the Party that holds the IND from the applicable Regulatory Authority in the Territory for such Clinical Trial in its name. |
1.206 | Territory-Specific Clinical Trial means a Clinical Trial for a Licensed Product, the data from which at the time of commencement is intended to be used to obtain, support, or maintain Regulatory Approval in the Territory but not to obtain, support, or maintain Regulatory Approval in any of the following: [****]. |
1.207 | Territory-Specific Development Plans has the meaning set forth in Section 5.4 (Territory-Specific Development Plans). |
1.208 | Third Party means any Person other than a Party or an Affiliate of a Party. |
1.209 | Third Party Claims means collectively, any and all Third Party demands, claims, actions, suits, and proceedings (whether criminal or civil, in contract, tort, or otherwise). |
1.210 | Third Party Distributor means any Third Party that purchases Licensed Product from Zai or its Affiliates, or Sublicensees, takes title to such Licensed Product, and distributes such Licensed Product directly to customers, but does not Develop or Manufacture any Blueprint Compound or Licensed Product and does not make any royalty, profit-share, or other payment to Zai or its Affiliates or Sublicensees, other than payment for the purchase of Licensed Products for resale. |
1.211 | Third Party IP Agreement means any agreement with a Third Party entered into by Blueprint or Zai respect to a grant of rights under any Blueprint Identified Rights or Zai Identified Rights. |
1.212 | United States or U.S. means the United States of America and its territories and possessions. |
1.213 | Upfront Payment has the meaning set forth in Section 10.1 (Upfront Payment). |
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1.214 | Valid Claim means with respect to a particular country or region, a claim in any (a) unexpired and issued Patent Right that has not been irretrievably lapsed or been abandoned, disclaimed, permanently revoked, dedicated to the public, or held invalid, unenforceable, or not patentable by a final non-appealable decision of a court of competent jurisdiction or Governmental Authority in such country or region, or (b) pending patent application that has been pending for [****]; provided that, if a claim ceases to be a Valid Claim by reason of foregoing subclause (b), then such claim would again be deemed a Valid Claim in the event such claim subsequently issues prior to the end of the then-current Royalty Term in such country or region. |
1.215 | VAT has the meaning set forth in Section 1.201 (Tax). |
1.216 | VAT Credit has the meaning set forth in Section 10.13 (VAT Credits). |
1.217 | Working Group has the meaning set forth in Section 3.4 (Working Groups). |
1.218 | Zai has the meaning set forth in the Preamble. |
1.219 | Zai Collaboration Know-How means Collaboration Know-How, other than Blueprint/Zai Combination Know-How or Assigned Collaboration Know-How, developed or invented solely by Zais or its Affiliates, licensees, Sublicensees, or Subcontractors employees, agents, or independent contractors, or any Persons that are contractually required to assign or license such Collaboration Know-How (or Patent Rights Covering such Know-How) to Zai or any Affiliate of Zai, in each case, in the performance of activities under this Agreement during the Term. |
1.220 | Zai Collaboration Patent Rights means all Collaboration Patent Rights that Cover Zai Collaboration Know-How. For clarity, Zai Collaboration Patent Rights do not include any Blueprint/Zai Combination Patent Rights or Assigned Collaboration Patent Rights. |
1.221 | Zai Collaboration Technology means Zai Collaboration Know-How and Zai Collaboration Patent Rights. |
1.222 | Zai Identified General Rights has the meaning set forth in Section 2.6.2 (Zai Identified Rights). |
1.223 | Zai Identified Rights has the meaning set forth in Section 2.6.2 (Zai Identified Rights). |
1.224 | Zai Indemnitee(s) has the meaning set forth in Section 13.2 (By Blueprint). |
1.225 | Zai In-Licensed Rights has the meaning set forth in Section 2.6.2 (Zai Identified Rights). |
1.226 | Zai Know-How means, subject to Section 2.6.6 (Right to Decline Zai In-Licensed Rights), all Know-How (excluding Zais interest in Blueprint/Zai Combination Know-How and other Joint Collaboration Know-How) that is (a) Controlled by Zai or any of its Affiliates as of the Effective Date or during the Term, and (b) used by either Party in the Exploitation of a Blueprint Compound or a Licensed Product, including all Zai Collaboration Know-How. |
1.227 | Zai Patent Rights means, subject to Section 2.6.6 (Right to Decline Zai In-Licensed Rights), all Patent Rights (excluding Zais interest in Blueprint/Zai Combination Patent Rights and other Joint Collaboration Patent Rights) that are (a) Controlled by Zai or any of its Affiliates as of the Effective Date or during the Term; and (b) practiced by either Party in the Exploitation of a Blueprint Compound or a Licensed Product, including all Zai Collaboration Patent Rights. |
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1.228 | Zai Product means any pharmaceutical or biologic product with respect to which Zai or any of its Affiliates has exclusive rights to Exploit inside the Territory or outside of the Territory, including all forms, modifications, and variants thereof that are Controlled by Zai, in each case, at the time that the JSC agrees in writing to include a Blueprint/Zai Combination containing such Zai Product under this Agreement pursuant to Section 5.8.1 (Proposed Blueprint/Zai Combinations) or Section 5.9 (New Development Proposed by Zai). |
1.229 | Zai Publication has the meaning set forth in Section 11.5.1. |
1.230 | Zai Specifications has the meaning set forth in Section 7.2.3 (Specifications). |
1.231 | Zai Technology means Zai Know-How, Zai Patent Rights, and Zais interest in the Joint Collaboration Technology. |
1.232 | Zai Third Party IP Agreement has the meaning set forth in Section 2.6.6(b) (Right to Decline Zai In-Licensed Rights). |
Article 2
LICENSES
2.1 | License Grants to Zai. |
2.1.1 | In the Territory. Subject to the terms of this Agreement, Blueprint hereby grants to Zai (a) an exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.2 (Sublicensing and Subcontractors), under the Blueprint Technology to Exploit (other than to conduct or have conducted Non-Clinical Development, or Manufacture or have Manufactured) the Blueprint Compounds and the Licensed Products in the Field in the Territory in accordance with the Territory-Specific Development Plans, Global Development Plans, the Medical Affairs Plans, and the Commercialization Plans or as otherwise expressly permitted by this Agreement and (b) a non-exclusive, royalty-bearing license, with the right to grant sublicenses solely in accordance with Section 2.2 (Sublicensing and Subcontractors), under the Blueprint Technology to [****] in the Field in the Territory. Zai will not practice the Blueprint Technology licensed to Zai under this Section 2.1.1 (In the Territory) except as expressly set forth in the Territory-Specific Development Plans, Global Development Plan, Medical Affairs Plans, and Commercialization Plans or to conduct other activities expressly permitted under this Agreement. Notwithstanding any provision to the contrary set forth in this Agreement, [****]. |
2.1.2 | Manufacturing License. Subject to the terms of this Agreement, effective upon the commencement of the Manufacturing Technology Transfer to Zai for the Manufacture of the Licensed Products in accordance with Section 7.2.2 (Clinical and Commercial Supply), Blueprint hereby grants to Zai [****] in accordance with and subject to the terms of this Agreement, including pursuant to Section 7.2 (Supply by Zai). Zai will not practice the Blueprint Manufacturing Technology licensed to Zai under this Section 2.1.2 (Manufacturing License) until the commencement of the Manufacturing Technology Transfer to Zai for the Manufacture of the Licensed Products in accordance with Section 7.2.2 (Clinical and Commercial Supply). |
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2.2 | Sublicensing and Subcontractors. |
2.2.1 | Right to Sublicense. Subject to the terms of this Agreement, Zai will have the right to grant sublicenses of the rights granted under Section 2.1 (License Grants to Zai) to (a) its Affiliates, provided that any such sublicense will automatically terminate if such Person ceases to be an Affiliate of Zai, (b) Development Subcontractors and Third Party Distributors in accordance with this Section 2.2 (Sublicensing and Subcontractors), and (c) subject to Blueprints prior written approval, not to be unreasonably withheld, conditioned, or delayed, Third Parties (other than Development Subcontractors and Third Party Distributors). Notwithstanding the foregoing, Zai will not grant a sublicense to a Third Party of all or substantially all of Zais rights or obligations under this Agreement with respect to one or more regions within the Territory without Blueprints prior written consent, which consent Blueprint may withhold, condition, or delay in its sole discretion. Each Sublicensee will hold its rights contingent on the rights licensed to Zai under the terms of this Agreement. Any termination of the licenses granted to Zai under Section 2.1 (License Grants to Zai) as a result of a termination of this Agreement with respect to one or more Licensed Products or in its entirety will, subject to Section 15.3.11 (Sublicense Survival), cause the Sublicensees to automatically lose the same rights under any sublicense. |
2.2.2 | Terms of Sublicenses to Third Parties. Zai will provide prior written notice to Blueprint identifying its intention to grant a sublicense under Section 2.2.1 (Right to Sublicense) to any Third Party (other than a sublicense granted by Zai to a Development Subcontractor or Third Party Distributor; provided that such engagement is otherwise in accordance with Section 2.2.3 (Right to Subcontract)), the purpose of such sublicense, and the identity of the Third Party to whom Zai intends to grant such sublicense. Each sublicense to a Third Party will be granted under a written agreement that is consistent with the terms of this Agreement and that (a) requires each such Third Party Sublicensee to which Zai grants a sublicense of the rights granted to Zai under Section 2.1 (License Grants to Zai) to comply with the terms of this Agreement that are applicable to such sublicense (including obligations of confidentiality and non-use at least as stringent as those set forth Article 11 (Confidentiality; Publication), as applicable, the Milestone Event and Royalty Payment reporting obligations set forth under Section 10.2 (Milestone Payments) and Section 10.3 (Royalty Payments to Blueprint), the record keeping and audit requirements set forth under Section 5.14 (Clinical Trial Audit Rights), Section 10.11 (Financial Records and Audits), and the intellectual property provisions set forth in Article 14 (Intellectual Property)), and (b) precludes the granting of further sublicenses in contravention with the terms of this Agreement. Without limiting the generality of the foregoing, each sublicense agreement with such a Third Party entered into after the Effective Date must include (i) [****], (ii) [****], and (iii) [****]. |
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2.2.3 | Right to Subcontract. Zai will not propose the engagement of any Subcontractor that is Debarred/Excluded. Zai may engage (a) Subcontractors solely to perform Zais Development activities with respect to Licensed Products under this Agreement on Zais behalf (each a Development Subcontractor) or (b) Third Party Distributors to distribute Licensed Products in the Territory on behalf of Zai, in either case, without Blueprints prior written consent, but subject to the requirements set forth in the first, the second to last, and the last sentence of this Section 2.2.3 (Right to Subcontract), Section 2.2.4 (Notices of Sublicensing and Subcontractors), Section 2.2.5 (Zai Audits of Sublicensees and Subcontractors), and Section 2.2.6 (Responsibility for Sublicensees and Subcontractors). Prior to Zais engagement of the first Subcontractor (other than a Development Subcontractor or Third Party Distributor), Zai will provide to the JSC to review, discuss, and determine whether to approve as Preapproved Subcontractors a list of Subcontractors that Zai may engage to perform its obligations and exercise its rights under this Agreement. In addition, during the term, Zai may propose additional Subcontractors to be approved by the JSC as Preapproved Subcontractors and following the approval by the JSC of any such additional Subcontractors, such Subcontractors will be Preapproved Subcontractors. Zai may engage any such Preapproved Subcontractor to perform Zais obligations and exercise of Zais rights under this Agreement. In addition, if Zai wishes to engage a Subcontractor (other than a Development Subcontractor or Third Party Distributor) that is not a Preapproved Subcontractor to perform its obligations or exercise its rights under this Agreement related to the (i) Manufacture of a Licensed Product following completion of the Manufacturing Technology Transfer, or (ii) the Commercialization of such Licensed Product in a region in the Territory, then, in each case ((i) and (ii)), Zai will provide written notice to Blueprint at least [****] before engaging any such Subcontractor identifying Zais intention to engage such Subcontractor, the purpose of engaging such Subcontractor, and the identity of such Subcontractor. Within [****] after the receipt of such written notice, Blueprint may provide written notice of its veto of Zais engagement of such proposed Subcontractor and in such case, Zai will not engage such Subcontractor to perform its obligations or exercise its rights under this Agreement, provided that Blueprint will not unreasonably veto such engagement. If Blueprint does not provide written notice to Zai of Blueprints veto of Zais engagement of a particular proposed Subcontractor within [****] after Blueprints receipt of such notice, then Zai may engage such proposed Subcontractor to perform its obligations or exercise its rights under this Agreement (subject to the terms set forth herein). Any agreement pursuant to which Zai engages any Subcontractor (including any Development Subcontractor or Third Party Distributor) must be consistent with the terms of this Agreement, including containing obligations of confidentiality and non-use at least as stringent as those set forth Article 11 (Confidentiality; Publication), and terms that are consistent with the intellectual property provisions set forth in Article 14 (Intellectual Property). Without limiting the generality of the foregoing, unless otherwise agreed by the Parties, each agreement pursuant to which Zai engages a Subcontractor (including any Development Subcontractor or Third Party Distributor) to Exploit Licensed Products hereunder must include [****]. |
2.2.4 | Notice of Sublicenses and Subcontracts. Zai will provide Blueprint with a true and complete copy of each sublicense or subcontracting agreement (including all schedules, exhibits, and appendices thereto) with any Third Party (including any Development Subcontractor or Third Party Distributor) within [****] after it becomes effective[****] Any sublicense granted under this Agreement must either be in English or [****]. |
2.2.5 | Zai Audits of Sublicensees and Subcontractors. Zai will provide Blueprint with copies of all quality oversight or audit reports from audits that Zai (or its agent) has conducted on any Sublicensees or Subcontractors that Zai engages to perform its obligations or exercise its rights under this Agreement with respect to any Licensed Product, as well as all corrective action plans resulting from any such audits, in each case, to the extent such reports and plans are relevant to such Sublicensees or Subcontractors performance of such obligations or exercise of such rights no later than [****]. |
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2.2.6 | Responsibility for Sublicensees and Subcontractors. Zai will require that all Sublicensees and Subcontractors perform the activities that they are sublicensed or engaged to perform (as applicable) in accordance with GLP, cGMP, and GCP, as applicable, and otherwise in compliance with Applicable Law. Notwithstanding any sublicense or subcontracting, Zai will remain primarily liable to Blueprint for the performance of all of its obligations under, and Zais compliance with all provisions of, this Agreement. Zai will be fully responsible and liable for any breach of the terms of this Agreement by any of its Sublicensees or Subcontractors to the same extent as if Zai itself has committed any such breach and will terminate the agreement with any Sublicensee or Subcontractor [****] if such Sublicensee or Subcontractor is in breach of this Agreement and neither Zai nor such Subcontractor cures such breach in a timely manner [****]. |
2.3 | License Grants to Blueprint. |
2.3.1 | Development Activities. Subject to the terms of this Agreement, Zai hereby grants to Blueprint a worldwide, non-exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers, under the Zai Technology to perform the Development activities for the Blueprint Compounds and the Licensed Products in the Field for which it is responsible under a Global Development Plan, including any Global Clinical Trial for a Licensed Product (including a POC Trial or other Development of any Blueprint/Zai Combination approved by the JSC pursuant to Section 5.8.1 (Proposed Combinations)). |
2.3.2 | Outside of the Territory. Subject to the terms of this Agreement, Zai hereby grants to Blueprint a perpetual, irrevocable, royalty-free license, with the right to grant sublicenses through multiple tiers, under the Zai Technology to Exploit the Blueprint Compounds and the Licensed Products in the Field outside of the Territory. Such license under this Section 2.3.2 (Outside of the Territory) will be (a) exclusive under the Zai Collaboration Technology and Zais interest in the Joint Collaboration Technology and (b) non-exclusive under all other Zai Technology. |
2.4 | Retained Rights. Nothing in this Agreement will be interpreted to grant a Party any rights under any intellectual property rights owned or Controlled by the other Party, including Blueprint Technology, Blueprint Manufacturing Technology, Joint Collaboration Technology, or Zai Technology, in each case, that are not expressly granted herein, whether by implication, estoppel, or otherwise. Any rights not expressly granted to Blueprint by Zai under this Agreement are hereby retained by Zai. Any rights not expressly granted to Zai by Blueprint under this Agreement are hereby retained by Blueprint. In addition, Blueprint expressly retains (a) the exclusive right under the Blueprint Technology (on behalf of itself and its licensees and Sublicensees, other than Zai, Zais Affiliates and Zais Sublicensees) to conduct Non-Clinical Development involving Blueprint Compounds or Licensed Products anywhere in the world (including in the Territory[****]), (b) the right under the Blueprint Technology to perform Development activities for the Blueprint Compounds and the Licensed Products in the Territory in accordance with this Agreement, including to conduct Development activities under a Global Development Plan as provided hereunder (including in the event that Zai declines, through the JSC, to participate in a Global Clinical Trial proposed by Blueprint under Section 5.11 (New Development Proposed by Blueprint) or fails to satisfy the Patient Commitment with respect to one or more Committed Trials), (c) the right under the Blueprint Technology (on behalf of itself and its licensees and Sublicensees, other than Zai, Zais Affiliates and Zais Sublicensees) to Manufacture Licensed Products in the Territory itself or through its Affiliates or Third Parties (i) for use by Zai and its authorized Sublicensees in the Territory or (ii) for use by Blueprint, or its licensees, Sublicensees, Affiliates or Third Parties outside of the Territory, (d) the right to perform Blueprints other obligations under this Agreement, (e) in the event that Zai does not participate in a Global Clinical Trial for one or more Licensed Products in one or more Indications or with respect to one or more Combination Products or Combination Regimens, the non-exclusive right to Develop Blueprint Compounds and Licensed Products through the use of clinical trial sites, CROs, and other Third Parties in the Territory in connection with the performance of such Global Clinical Trials, and (f) the exclusive right to Exploit the Blueprint Compounds and Licensed Products outside of the Territory. Zai will not practice the Blueprint Technology and Blueprint will not practice the Zai Technology, in each case, other than as expressly licensed and permitted under this Agreement or otherwise agreed by the Parties in writing. |
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2.5 | Combination Products Rights. Notwithstanding any other provision of this Agreement, for purposes of the license grants under Section 2.1 (License Grants to Zai) or Section 2.3 (License Grants to Blueprint), with respect to any Licensed Product that is a Combination Product or Combination Regimen, such license will only include rights with respect to any Blueprint Compound component of such Combination Product or Combination Regimen and not any other Active Ingredient Controlled by, as applicable, the Party granting such license (e.g., with respect to Zai, any Zai Product or with respect to Blueprint, a compound Controlled by Blueprint other than BLU-701 or BLU-945) or any of its Affiliates except in the event that [****]. |
2.6 | Third Party In-Licenses. |
2.6.1 | Blueprint Identified Rights. Blueprint will remain solely responsible for the payment of all royalties, license fees, milestone payments, and other payment obligations under all agreements entered into by Blueprint prior to the Effective Date. If, after the Effective Date during the Term, Blueprint intends to obtain Control of any Know-How or Patent Rights from a Third Party (whether by acquisition or license) that may be necessary or useful to Exploit one or more Blueprint Compounds or Licensed Products in the Field anywhere in the world (other than a Change of Control of Blueprint or as a result of the acquisition by Blueprint of a Third Party by merger, acquisition, or similar transaction or series of related transactions) (such Know-How and Patent Rights, Blueprint Identified Rights), then Blueprint will notify Zai in writing of such Blueprint Identified Rights and Section 2.6.3 (Third Party IP Agreements) will apply. |
2.6.2 | Zai Identified Rights. If Zai determines that a license under any Know-How or Patent Rights controlled by a Third Party is [****] (Zai Identified Rights), then Zai will [****]. Blueprint will have the first right to acquire rights to any such Zai Identified Rights from such Third Party (whether by acquisition or license)[****]. If [****], then Blueprint will notify Zai of such intention within [****] and the terms of Section 2.6.3 (Third Party IP Agreements) will apply. If (a) Blueprint [****] within such [****] period or otherwise [****], or (b) [****], then Zai will have the right to acquire rights under such Zai Identified Rights from such Third Party solely for the Territory or any region therein and any such right obtained by Zai will be referred to as Zai In-Licensed Rights. |
2.6.3 | Blueprint In-Licensed Rights. Prior to executing a Third Party IP Agreement with a Third Party to acquire or license any Blueprint Identified Rights or Zai Identified Rights (together, Blueprint In-Licensed Rights), Blueprint will (a) provide Zai an opportunity to review and comment on [****], including any [****] (b) take Zais comments into consideration [****] prior to finalizing such Third Party IP Agreement, and (c) ensure that such Third Party IP Agreement includes [****]. Upon execution of such Third Party IP Agreement, Blueprint will notify Zai in writing and will provide [****]. |
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2.6.4 | Responsibility for Costs of Blueprint In-Licensed Rights. Subject to Zais right to decline a license or sublicense of Blueprint In-Licensed Rights within [****] in accordance with the terms of Section 2.6.5 (Right to Decline Blueprint In-Licensed Rights), following Blueprints execution of the applicable Third Party IP Agreement (a) such Blueprint In-Licensed Rights will be included in the Blueprint Know-How or the Blueprint Patent Rights (as applicable) and licensed or sublicensed (as applicable) to Zai under the licenses granted in Section 2.1 (License Grants to Zai), subject to the terms of this Agreement and the applicable Third Party IP Agreement, and (b) Zai will reimburse Blueprint (i) [****] of any such payments under the applicable Third Party IP Agreement that [****] pertain to, or arise [****] as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products in the Territory (for example, [****]) by Zai or its Affiliates or Sublicensees, and (ii) with respect to any [****] payments payable in consideration for any Blueprint In-Licensed Rights that pertain to, or arise as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products both inside and outside of the Territory or are non-Territory-specific (for example, [****]), [****]. Blueprint will bear [****] of amounts payable in consideration for any Blueprint In-Licensed Rights that pertain to any product other than a Blueprint Compound or Licensed Product or that [****] pertain to, or arise [****] as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products outside of the Territory (for example, [****]). |
2.6.5 | Right to Decline Blueprint In-Licensed Rights. Zai will have the right to decline a license or sublicense (as applicable) from Blueprint under Blueprint In-Licensed Rights under a Third Party IP Agreement by providing written notice to Blueprint [****]. Upon Blueprints [****] receipt of such notice declining such a license or sublicense (as applicable) under any Blueprint In-Licensed Rights, Blueprint will not be deemed to Control such Blueprint In-Licensed Rights, the definitions of Blueprint Patent Rights and Blueprint Know-How will exclude such Blueprint In-Licensed Rights, as applicable, and such Blueprint In-Licensed Rights will not be included in the scope of the rights granted to Zai under Section 2.1 (License Grants to Zai). |
2.6.6 | Right to Decline Zai In-Licensed Rights; Responsibility for Costs. |
(a) | Zai In-Licensed Rights. Prior to executing a Third Party IP Agreement with a Third Party to acquire or license any Zai In-Licensed Rights, Zai will (i) provide Blueprint an opportunity to review and comment on [****], including any [****], (ii) take Blueprints comments into consideration [****] prior to finalizing such Third Party IP Agreement, and (iii) ensure that such Third Party IP Agreement includes [****]. Upon execution of such Third Party IP Agreement, Zai will notify Blueprint in writing and will provide [****]. |
(b) | Right to Decline Zai In-Licensed Rights. Blueprint will have the right to decline a license or sublicense (as applicable) from Zai under Zai In-Licensed Rights by providing written notice to Zai [****] (the Zai Third Party IP Agreement) [****]. Upon Zais [****] receipt of such notice declining such a license or sublicense (as applicable) under any Zai In-Licensed Rights, Zai will not be deemed to Control such Zai In-Licensed Rights, the definitions of Zai Patent Rights and Zai Know-How will exclude such Zai In-Licensed Rights, as applicable, and such Zai In-Licensed Rights will not be included in the scope of the rights granted to Blueprint under Section 2.3 (License Grants to Blueprint). |
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(c) | Responsibility for Costs of Zai In-Licensed Rights. Subject to Blueprints right to decline a license or sublicense of Zai In-Licensed Rights in accordance with the terms of Section 2.6.6(b) (Right to Decline Zai In-Licensed Rights), following Zais execution of the applicable Zai Third Party IP Agreement: (i) such Zai In-Licensed Rights will be included in the Zai Know-How or the Zai Patent Rights (as applicable) and licensed or sublicensed (as applicable) to Blueprint under the licenses granted in Section 2.3 (License Grants to Blueprint), subject to the terms of this Agreement and the applicable Zai Third Party IP Agreement, and (ii) Blueprint will reimburse Zai (A) [****] of any such payments under the applicable Zai Third Party IP Agreement that [****]pertain to, or arise [****] as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products outside the Territory (for example, [****] by Blueprint, its Affiliates or (sub)licensees, and (B) with respect to [****] payments payable in consideration for any Zai In-Licensed Rights that pertain to, or arise as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products both inside and outside of the Territory or are non-Territory-specific (for example, [****]), a [****]. Zai will bear [****]of amounts payable in consideration for any Zai In-Licensed Rights that pertain to any product other than a Blueprint Compound or Licensed Product or that [****] pertain to, or arise [****] as a result of, the Exploitation of the Blueprint Compounds or the Licensed Products in the Territory (for example, [****]). |
2.7 | [****] |
2.8 | Exclusivity. |
2.8.1 | Exclusivity Covenant. Subject to Section 2.8.3 (New Affiliate Exception), during the Term neither Party will, and will ensure that its Affiliates and Sublicensees do not, independently or for or with any Third Party, [****] unless agreed in writing by the Parties (the Competitive Activities). |
2.8.2 | Competitive Product Disputes. If a Party disputes whether a pharmaceutical or biologic product is a Competitive Product, then the Parties will refer the matter to the head of Research & Development of Zai and Blueprint (or, if a Party does not have a head of Research & Development, its most senior employee having the equivalent responsibilities) or their designees (the Scientific Officers). The Scientific Officers will meet [****] to discuss and resolve the matter within [****] after referral of such matter to such Scientific Officers. If the Scientific Officers cannot agree on a resolution to the matter within such [****] period, then the Parties will refer such matter for resolution to an independent Third Party expert agreed upon by the Parties within [****] after the Scientific Officers failed to resolve such matter. Such independent Third Party expert will be [****], and unless otherwise agreed in writing by the Parties, must not [****]. Such expert will make its determination as to whether the applicable pharmaceutical or biologic product is a Competitive Product [****]. The Party bringing a dispute pursuant to this Section 2.8.2 (Competitive Product Disputes) will [****] engage such expert and the Parties will share the out-of-pocket costs incurred in connection with the engagement of such expert [****]. Within [****] of the engagement of such expert by the disputing Party, such expert will deliver a written decision to the Parties on the matter as to whether such product is a Competitive Product (including a detailed report as to such experts rationale for such decision), and such decision will be binding on the Parties. |
2.8.3 | New Affiliate Exception. Notwithstanding Section 2.8.1 (Exclusivity Covenant), if (1) a Third Party becomes an Affiliate of a Party during the Term through merger, acquisition, consolidation, Change of Control, or other similar transaction (any such Third Party, a New Affiliate) and (2) such New Affiliate, as of the execution date of the definitive agreement with respect to such transaction, is engaged in Competitive Activities with respect to one or more Competitive Products, then: |
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(a) | If such transaction results in a Change of Control of a Party, then such New Affiliate of such Party (the Acquiror) and such Party and their respective Affiliates may continue to perform such Competitive Activities after such Change of Control and such Party will not be in violation of its exclusivity obligations set forth in Section 2.8.1 (Exclusivity Covenant), as long as (i) no Confidential Information of the other Party or Blueprint Technology (if the acquired Party is Zai) or Zai Technology (if the acquired Party is Blueprint) is used by or on behalf of such Party, its Acquiror and their respective Affiliates in connection with any such Competitive Activities, and (ii) such Party, its Acquiror and their respective Affiliates institute commercially reasonable [****] safeguards to ensure the requirements set forth in the foregoing clause (i) are met, including by creating firewalls between the personnel working on such Competitive Activities and the personnel teams charged with working on the Blueprint Compounds and Licensed Products hereunder or having access to data from activities performed under this Agreement or to the Confidential Information of the other Party. |
(b) | If such transaction does not result in a Change of Control of a Party, then such Party (i) will provide to the other Party [****], (ii) unless the Parties agree otherwise in writing, such Party and its New Affiliate (an Acquiree) will take one of the following actions set forth below in clauses (A) or (B) and (iii) no later than [****] following the date of consummation of the relevant acquisition transaction, such Party will notify the other Party of which of the actions in the following clauses (A) or (B), it will pursue: (A) divest, or cause its Acquiree to divest, whether by license or otherwise, its interest in the program of applicable Competitive Activities; or (B) terminate any further Competitive Activities. If such Party notifies the other Party in writing that it intends to divest the program of applicable Competitive Activities or terminate the performance of the applicable Competitive Activities, then such Party or its Acquiree will effect the consummation of such divestiture within [****] (or such other period as may be required to comply with Applicable Law), or effect such termination of the program of applicable Competitive Activities within [****], in each case, after the closing of the relevant transaction and will confirm to the other Party in writing when it completes such divestiture pursuant to clause (A) or termination pursuant to clause (B). Such Party will keep the other Party reasonably informed of its efforts and progress in effecting such divesture or termination until such Party or its Acquiree completes the same. During such [****] or [****] period, as applicable, such Party and its Acquirees and their respective Affiliates conduct of such Competitive Activities will not constitute a breach by such Party of its exclusivity obligations set forth in Section 2.8.1 (Exclusivity Covenant), as long as during such period, (I) no Confidential Information of the other Party or Blueprint Technology (if the acquiring Party is Zai) or Zai Technology (if the acquiring Party is Blueprint) is used by or on behalf of such acquiring Party, its Acquiree, and their respective Affiliates in connection with any such Competitive Activities, and (II) such acquiring Party, its Acquiree and their respective Affiliates institute commercially reasonable [****] safeguards to ensure the requirements set forth in the foregoing clause (I) are met, including by creating firewalls between the personnel working under such Competitive Activities and the personnel teams charged with working on the Blueprint Compounds and Licensed Products hereunder or having access to data from activities performed under this Agreement or Confidential Information of the other Party. |
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Article 3
GOVERNANCE
3.1 | Alliance Managers. Each Party will appoint an individual to act as its alliance manager under this Agreement as soon as practicable after the Effective Date (each an Alliance Manager). The Alliance Managers will: (a) serve as the primary points of contact between the Parties for the purpose of providing the other Party with information on the progress of a Partys activities under this Agreement; (b) be responsible for facilitating the flow of information and otherwise promoting communication, coordination, and collaboration between the Parties, all of which communications between the Parties will be in English; (c) facilitate the prompt resolution of any disputes; and (d) attend JSC, JPT, and Working Group meetings, in each case, as a non-voting member. An Alliance Manager may also bring any matter to the attention of the JSC, a JPT, or applicable Working Group if such Alliance Manager reasonably believes that such matter warrants such attention. Each Party will use reasonable efforts to keep an appropriate level of continuity but may replace its Alliance Manager at any time upon written notice to the other Party. |
3.2 | Joint Steering Committee. |
3.2.1 | Formation. No later than [****] after the Effective Date, the Parties will establish a joint steering committee (the JSC) to monitor and coordinate the Exploitation of the Blueprint Compounds and the Licensed Products in the Territory. The JSC will be composed of [****] representatives from each Party (unless otherwise agreed by the Parties) who are fluent in English and who have the appropriate and direct knowledge and expertise and requisite decision-making authority. Each Party may replace any of its representatives on the JSC and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a representative will notify the other Party at least [****] prior to the next scheduled meeting of the JSC. Both Parties will use reasonable efforts to keep an appropriate level of continuity in representation. Representatives may be represented at any meeting by another person designated by the absent representative. The JSC will be chaired by one of the representatives (JSC Chairperson) and will rotate between the Parties every 12 months during the Term. The initial JSC Chairperson of the JSC will be a representative of Zai for the period ending [****], and a Blueprint representative will become the JSC Chairperson of the JSC for the next [****] period during the Term. The role of the JSC Chairperson will be to convene and preside at meetings of the JSC and to ensure that the Alliance Managers prepare minutes, but the JSC Chairperson will have no additional powers or rights beyond those held by the other JSC representatives. Each Partys representatives on the JSC will inform and coordinate within their respective organization to enable each Party to fulfill its obligations as agreed upon between the Parties under this Agreement, including within the time frames set forth hereunder. |
3.2.2 | Meeting Agendas. Each Party will disclose to the other Party the proposed agenda items along with appropriate information at least [****] in advance of each meeting of the JSC; provided that under exigent circumstances requiring JSC input, a Party may provide its agenda items to the other Party within a shorter period of time in advance of a meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such JSC meeting. |
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3.2.3 | Meetings. The JSC will hold meetings at such times as it elects to do so, but will meet no less frequently than quarterly, unless otherwise agreed by the Parties. All meetings will be conducted in English. The JSC may meet in person or by means of teleconference, internet teleconference, videoconference, or other similar communication method; provided that, [****] meeting each Calendar Year will be conducted in person at a location selected alternatively by Blueprint and Zai or such other location as the Parties may agree. Each Party will be responsible for all of its own costs and expenses of participating in any JSC meeting. The Alliance Managers will jointly prepare and circulate minutes for each JSC meeting within [****] after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [****] thereafter. |
3.2.4 | JSC Roles and Responsibilities. The responsibilities of the JSC will be to: |
(a) | provide a forum for the discussion of the Parties activities under this Agreement; |
(b) | review, discuss, and determine whether to approve the initial list of Preapproved Subcontractors and any updates thereto, as described in Section 2.2.3 (Right to Subcontract); |
(c) | oversee the JPTs and establish and oversee Working Groups as necessary or advisable to further the purpose of this Agreement and settle any disputes that arise within any JPT or Working Groups, as described in Section 3.6.2 (Resolution of JPT and Working Group Disputes); |
(d) | oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; |
(e) | review, discuss, and determine whether to approve each Manufacturing Technology Transfer Plan, as described in Section 4.2 (Manufacturing Technology Transfer); |
(f) | review, discuss, and determine whether to approve any change in the scope of Manufacturing activities to be transferred to Zai in connection with the Manufacturing Technology Transfer for any Blueprint Compound and any updates or amendments thereto, as described in Section 4.2 (Manufacturing Technology Transfer); |
(g) | review, discuss, and determine whether to approve the [****] PRC Submission Estimated Timeline for each Licensed Product and each update thereto for each Licensed Product, in each case, as described in Section 5.6.2 (Amendments and Obligations); |
(h) | review, discuss, and determine whether to approve the initial Territory-Specific Development Plan for each Licensed Product and each update thereto, in each case, as described in Section 5.4 (Territory-Specific Development Plans); |
(i) | review and discuss the initial Global Development Plan for each Licensed Product and each update thereto for any Licensed Product, in each case, as described in Section 5.1 (Global Development Plan); |
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(j) | review, discuss, and determine whether to approve allocation to Zai of any new or additional activities under the Global Development Plan, including any additional Committed Trials proposed by Blueprint, as described in Section 5.1 (Global Development Plan); |
(k) | review, discuss, and determine whether to approve for Development under this Agreement [****]; |
(l) | review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.9 (New Development Proposed by Zai); |
(m) | review, discuss, and determine whether to approve the regulatory strategy for the Territory with respect to each Licensed Product and each update thereto, as described in Section 6.1 (Regulatory Strategy); |
(n) | review and discuss Zais plan for undertaking additional regulatory activities for any Licensed Product delegated by Blueprint or the JSC to Zai, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); |
(o) | review, discuss, and determine matters that may have a material adverse impact upon the regulatory status of the Licensed Products pursuant to Section 6.7 (No Harmful Actions); |
(p) | discuss and determine whether to approve [****]; |
(q) | review, discuss, and determine whether to approve each Medical Affairs Plan and each update thereto, as described in Section 8.1 (Medical Affairs Plans); |
(r) | review, discuss, and determine whether to approve each Commercialization Plan and each update thereto, as described in Section 9.2 (Commercialization Plans); |
(s) | determine whether a Product Mark is not appropriate for the Territory due to linguistic reasons or market research showing that such Product Mark is not appropriate, and review and comment on any alternative Product Marks selected by Zai, in each case, as described in Section 14.9.2 (Product Marks in the Territory); |
(t) | review, discuss, and determine whether to approve any brand strategy for a Licensed Product that is specific to the Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product, as described in Section 9.2 (Commercialization Plans); |
(u) | review, discuss, and determine whether to approve any alternative Licensed Product-specific trademark selected by Zai in accordance with Section 14.9.2 (Product Marks in the Territory); and |
(v) | perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties written agreement. |
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3.3 | Joint Project Teams. |
3.3.1 | Formation; Composition; Meetings. No later than [****], the Parties will form one or more joint project teams to coordinate and oversee the day-to-day performance of the activities and obligations of the Parties under this Agreement related to the Exploitation of each Blueprint Compound and the corresponding Licensed Products (each, a JPT). Each JPT will be composed of representatives from each Party who have direct knowledge and expertise in each of the following functional areas (as applicable depending on the stage of the applicable Licensed Products): clinical, clinical operations, pharmaceutical and biologic product development (including Companion Diagnostics, to the extent applicable), regulatory, safety, manufacturing, intellectual property, marketing, and commercial, in each case, as such functional areas relate to products similar to the applicable Licensed Product. Initially, only one JPT will be formed for all Licensed Products, but the JPT may during the Term elect to form separate JPTs for one or more Licensed Products. Each Party may replace any of its representatives on a JPT and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a representative will notify the other Party at least [****] prior to the next scheduled meeting of the applicable JPT. An individual may serve on more than one JPT and each Party will use reasonable efforts to keep an appropriate level of continuity in representation. Representatives may be represented at any meeting by another person designated by the absent representative. Each Partys representatives on the JPT will inform and coordinate within their respective organization to enable each Party to fulfill its obligations within the time frames as agreed upon between the Parties under this Agreement. Each JPT will be chaired by one of the representatives (JPT Chairperson) and will rotate between the Parties every [****] during the Term. The initial JPT Chairperson of each JPT will be a representative of Blueprint for the period [****] and a Zai representative will become the JPT Chairperson of each JPT for the next [****] period during the Term. Each JPT will meet as frequently as, and will operate as, the JSC may determine [****]. The role of the JPT Chairperson will be to convene and preside at meetings of the applicable JPT and to ensure that the Alliance Managers prepare minutes, but the JPT Chairperson will have no additional powers or rights beyond those held by the other JPT representatives. The JPTs may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communications method, and the JPT for each Blueprint Compound and corresponding Licensed Products may hold meetings at the same time as one or more other JPTs if agreed by the Parties. All meetings of each JPT will be held in English. Each JPT and its activities will be subject to the oversight of, and will report to, the JSC. In no event will the authority of any JPT exceed the authority of the JSC. Each Party will be responsible for all of its own costs and expenses of participating in the JPTs. The Alliance Managers will jointly prepare and circulate minutes for each JPT meeting within [****] after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [****] thereafter. |
3.3.2 | JPT Roles and Responsibilities. The responsibilities of the JPT will be to: |
(a) | oversee the day-to-day performance of the activities and obligations of each Party under this Agreement related to the Exploitation of each Blueprint Compound and Licensed Product; |
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(b) | discuss and develop the Manufacturing Technology Transfer Plan for each Blueprint Compound, as described in Section 4.2 (Manufacturing Technology Transfer); |
(c) | review and discuss updates of any Blueprint Know-How related to any Blueprint Compound or Licensed Product developed by Blueprint or its Affiliates or licensees since the previous meeting, as described in Section 4.3 (Continuing Know-How Transfer); |
(d) | review, discuss, and submit to the JSC the [****] PRC Submission Estimated Timeline for each Licensed Product and each update thereto for each Licensed Product, as described in Section 5.6.2 (Amendments and Obligations); |
(e) | review, discuss, provide comments on, and submit to the JSC the Territory-Specific Development Plan for each Licensed Product, and each update thereto, as described in Section 5.4 (Territory-Specific Development Plans); |
(f) | review, discuss, and determine whether to approve the inclusion of any Non-Clinical Development in the Territory-Specific Development Plan for a Licensed Product, as described in Section 5.7 (Non-Clinical and Preclinical Studies); |
(g) | review and discuss the Global Development Plan for each Licensed Product, and each update thereto, as described in Section 5.1 (Global Development Plans); |
(h) | discuss, develop, and submit to the JSC the Global Development Plan for any Proposed Blueprint/Zai Combination, as described in Section 5.8.1 (Proposed Blueprint/Zai Combinations); |
(i) | review, discuss, provide comments on, and submit to the JSC any update to the Territory-Specific Development Plan for any Licensed Product that includes any New Territory-Specific Development Activities that have been approved by the JSC, as described in Section 5.9.1(a) (JSC Approval); |
(j) | discuss, develop, and submit to the JSC the regulatory strategy for the Territory for each Licensed Product, as described in Section 6.1 (Regulatory Strategy); |
(k) | review and monitor the Parties compliance with the Safety Agreements, as described in Section 6.5.1 (Safety Agreements); |
(l) | review and monitor the Parties compliance with and performance under the Clinical Supply Agreement, the Commercial Supply Agreement, and any other written agreement between the Parties with respect to the subject matter hereof, and review and discuss Manufacturing of the Licensed Products by each Party for the Territory; |
(m) | review, discuss, and comment on the Medical Affairs Plan for each Licensed Product and each update thereto, as described in Section 8.1 (Medical Affairs Plans); |
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(n) | review and discuss each report provided by Zai of the Medical Affairs activities performed by or on behalf of Zai in the Territory for each Licensed Product, as described in Section 8.3 (Medical Affairs Reports); |
(o) | review, discuss, and comment on the Commercialization Plan for each Licensed Product and each update thereto, as described in Section 9.2 (Commercialization Plans); |
(p) | review and discuss each report provided by Zai of the Commercialization activities performed by or on behalf of Zai in the Territory for each Licensed Product, as described in Section 9.4 (Commercialization Reports); |
(q) | coordinate activities between the Parties with respect to certain Commercialization and Medical Affairs activities for the Licensed Products inside and outside of the Territory, as described in Section 8.4 (Coordination of Medical Affairs Activities) and Section 9.5 (Coordination of Commercialization Activities; Blueprint Support), respectively; |
(r) | raise matters for which the JPT is responsible to the JSC for discussion or resolution as appropriate; and |
(s) | perform such other functions as expressly set forth in this Agreement or allocated to JPT by the Parties written agreement or by the JSC. |
3.4 | Working Groups. From time to time, the JSC may establish joint working groups (each, a Working Group) on an as-needed basis to oversee specific functional areas or activities and coordinate the day-to-day performance of such activities under this Agreement, which establishment of Working Groups will be reflected in the minutes of the meetings of the JSC. Each such Working Group will have at least two representatives of each Party and will be otherwise constituted, will meet as frequently as, and will operate as the JSC may determine. Working Groups may meet in person or by means of teleconference, Internet conference, videoconference, or other similar communications method. Each Working Group and its activities will be subject to the oversight of, and will report to, the JSC. In no event will the authority of any Working Group exceed the authority of the JSC. Each Party will be responsible for all of its own costs and expenses of participating in any Working Group. The Alliance Managers will jointly prepare and circulate minutes for each Working Group meeting within [****] after each such meeting and will ensure that such minutes are reviewed and approved by their respective companies within [****] thereafter. |
3.5 | Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend a meeting of the JSC (in a non-voting capacity), a JPT, or any Working Group if such participants have expertise that is relevant to the planned agenda for such JSC, JPT, or Working Group meeting; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, then such Party will provide prior written notice to the other Party reasonably in advance of such meeting and will ensure that such Third Party is bound by obligations of confidentiality and non-use at least as stringent as those set forth in Article 11 (Confidentiality; Publication). Notwithstanding anything to the contrary set forth in this Agreement, if the other Party objects in good faith to the participation of such Third Party in such meeting due to a bona fide concern regarding competitively sensitive information that is reasonably likely to be discussed at such meeting (i.e., a consultant that also provides services to a Third Party with a Competitive Product), then such Third Party will not be permitted to participate in such meeting (or the portion thereof during which such competitively sensitive information is reasonably likely to be discussed). |
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3.6 | Decision-Making. |
3.6.1 | General Process. The JSC, the JPTs, and any Working Group will only have the powers expressly assigned to it in this Article 3 (Governance) and elsewhere in this Agreement and will not have the authority to: (a) modify or amend the terms of this Agreement; or (b) waive either Partys compliance with the terms of this Agreement. All decisions of the JSC, a JPT, and any Working Group will be made by unanimous vote, with each Partys representatives having one vote (i.e., one vote per Party). No action taken at any meeting of the JSC or any JPT or Working Group will be effective unless there is a quorum at such meeting, and at all such meetings, a quorum will be reached if two voting representatives of each Party are present or participating in such meeting. [****] |
3.6.2 | Resolution of JPT and Working Group Disputes. The JSC will [****] to resolve all disputes that arise within a JPT or any Working Group within [****] after any such matter is brought to the JSC for resolution. |
3.6.3 | Decisions of the JSC. The JSC [****] to promptly resolve any such matter for which it has authority. If [****] the JSC is unable to resolve any such matter referred to it by the JPT or any Working Group or any matter that is within the scope of the JSCs authority or any other disagreement between the Parties that may be referred to the JSC, in each case, within a period of [****], then a Party may refer such matter for resolution in accordance with 3.7.1 (Referral to Executive Officers) to the Chief Executive Officer of Blueprint (or an executive officer of Blueprint designated by the Chief Executive Officer of Blueprint who has the power and authority to resolve such matter) and the Chief Executive Officer of Zai (or an executive officer of Zai designated by the Chief Executive Officer of Zai who has the power and authority to resolve such matter) (collectively, the Executive Officers). |
3.7 | Resolution of JSC Disputes. |
3.7.1 | Referral to Executive Officers. If a Party makes an election under Section 3.6.3 (Decisions of the JSC) to refer a matter on which the JSC cannot reach a consensus decision for resolution by the Executive Officers, then the JSC will submit in writing the respective positions of the Parties to their respective Executive Officers. The Executive Officers will [****] to resolve any such matter so referred to them [****], and any final decision that the Executive Officers agree to in writing will be conclusive and binding on the Parties. |
3.7.2 | Final Decision-Making Authority. If the Executive Officers are unable to reach agreement on any such matter referred to them [****] after such matter is so referred (or such longer period as the Executive Officers may agree upon), then: |
(a) | No Change; Status Quo. Neither Party will have final decision-making authority [****] and all such matters set forth in the foregoing [****] must be decided by unanimous agreement of the Parties in order to take any action or adopt any change from the then-current status quo. |
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(b) | Zai Decisions. Except for any decision listed in Section 3.7.2(a) (No Change; Status Quo), Zai will have final decision-making authority with respect to [****]; provided that: |
(i) | [****]; and |
(ii) | [****]. |
(c) | Blueprint Decisions. Except for any decision listed in Section 3.7.2(a) (No Change; Status Quo), Blueprint will have final decision-making authority with respect to [****] provided that [****]. |
3.7.3 | Limitations on Decision-Making. Notwithstanding any provision to the contrary set forth in this Agreement, without the other Partys prior written consent, no decision of the JSC or a Partys Executive Officer (in the exercise of a Partys final decision-making authority on any such matters), in each case, may make a decision that could reasonably be expected to (a) result in a [****] in the other Partys obligations, costs, or expenses under this Agreement, or any Global Development Plan or Territory-Specific Development Plan, unless, in each case, such actions are necessary for Blueprint to comply with Applicable Law as the Territory Sponsor or as the owner and holder of any Regulatory Submission, Regulatory Approval, or Reimbursement Approval, as applicable, for a Licensed Product in the Territory, (b) require the other Party to take any action that such other Party [****] would (i) require such other Party to violate any Applicable Law, the requirements of any Regulatory Authority, or any agreement with any Third Party entered into by such other Party or (ii) require such other Party to infringe or misappropriate any intellectual property rights of any Third Party, (c) conflict with, amend, interpret, modify, or waive compliance under this Agreement, or (d) impose any obligation on either Party that would be in violation of such Partys written standard operating procedures, written business policies, or written compliance policies or procedures. |
3.8 | Discontinuation of JSC. The JSC will continue to exist until the first to occur of (a) the Parties agreeing to disband the JSC, or (b) Blueprint providing written notice to Zai of its intention to disband and no longer participate in the JSC. Once the JSC is disbanded, the JSC will have no further obligations under this Agreement and, thereafter, the Alliance Managers will be the points of contact for the exchange of information between the Parties under this Agreement and any references in this Agreement to decisions of the JSC will automatically become references to decisions by and between the Parties in writing, subject to the other terms of this Agreement and consistent with the terms of Section 3.7.2 (Final Decision-Making Authority). |
Article 4
TECHNOLOGY TRANSFERS
4.1 | Initial Know-How Transfer. [****] Blueprint will provide and transfer to Zai copies of Blueprint Know-How (other than Blueprint Manufacturing Know-How, the transfer of which will be performed pursuant to Section 4.2 (Manufacturing Technology Transfer)) that exists on the Effective Date to the extent not previously provided to Zai, including data and results required for Zai to file an IND for the Licensed Products, in each case, in the Territory (the Initial Know-How Transfer). Blueprint may make such Blueprint Know-How available in such reasonable form as Blueprint determines, including, if Blueprint so elects, in the form such Blueprint Know-How is maintained by Blueprint. |
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4.2 | Manufacturing Technology Transfer. |
4.2.1 | Initiation of Manufacturing Technology Transfer. In addition to the Blueprint Know-How provided to Zai pursuant to the Initial Know-How Transfer, unless otherwise agreed by the Parties, on a Blueprint Compound-by-Blueprint Compound basis, upon [****] commencing [****] and ending no later than [****], Blueprint and Zai will jointly develop a draft Manufacturing Technology Transfer Plan for such Licensed Products containing such Blueprint Compound. Notwithstanding the foregoing, Blueprint will have the right to elect to initiate a Manufacturing Technology Transfer with respect to a Blueprint Compound at any time during the Term by developing a draft Manufacturing Technology Transfer Plan for Licensed Products containing such Blueprint Compound. |
4.2.2 | Approval of Manufacturing Technology Transfer Plans. Following development thereof, either Party will submit each Manufacturing Technology Transfer Plan to the JPT to review and discuss, and thereafter to the JSC to review, discuss, and determine whether to approve no later than [****] following either Partys submission to the JPT of each such plan. Blueprint or Zai may propose updates or amendments to any Manufacturing Technology Transfer Plan from time to time, and such updates or amendments will become effective upon approval thereof by the JSC. |
4.2.3 | Manufacturing Transfer Plan Requirements. Unless otherwise agreed by the JSC, each initial Manufacturing Technology Transfer Plan will contemplate the transfer to Zai of, at minimum, all Manufacturing steps that are necessary for Zai to obtain all applicable Regulatory Approvals (including Local Manufacturing Approvals) required to market and sell a locally-Manufactured version of such Licensed Product in the PRC in the name of Zai or its Affiliate. If transfer of the Manufacture [****] of a Blueprint Compound is not [****] for Zai to obtain all applicable Regulatory Approvals (including Local Manufacturing Approvals) required to market and sell a locally-Manufactured version of such Licensed Product in the PRC in the name of Zai or its Affiliate, and Manufacture [****] is not otherwise transferred to Zai under the initial Manufacturing Technology Transfer Plan for such Blueprint Compound, then, if requested by Zai and agreed to by Blueprint, Blueprint will prepare and submit to the JSC for approval, a Manufacturing Technology Transfer Plan for the transfer of Manufacture to Zai [****] of such Blueprint Compound. |
4.2.4 | Performance of Manufacturing Technology Transfers. If the Manufacturing Technology Transfer Plan for a Blueprint Compound contemplates the Manufacturing of the applicable Licensed Product from [****], then Blueprint will supply to Zai each of such [****] in accordance with Article 7 (Manufacturing). [****] Blueprint will perform (or cause one or more applicable Third Parties (including any CMO engaged by Blueprint to Manufacture such Licensed Product) to perform) a Manufacturing Technology Transfer for such Licensed Products containing such Blueprint Compound in accordance with such plan. The Parties will [****] complete the Manufacturing Technology Transfer for Licensed Products containing each Blueprint Compound [****] following the approval of the applicable Manufacturing Technology Transfer Plan pursuant to the applicable Manufacturing Technology Transfer Plan, but in any event [****]. Without limiting the foregoing, the Parties will [****] to complete a Manufacturing Technology Transfer with respect to each Licensed Product [****]. Thereafter during the Term, Blueprint (a) will provide Blueprint Manufacturing Know-How as part of the Continuing Know-How Transfer in accordance with Section 4.3 (Continuing Know-How Transfer) and (b) may transfer additional Manufacturing steps with respect to a Blueprint Compound to Zai by proposing another Manufacturing Technology Transfer Plan (or an amendment or update to a prior Manufacturing Technology Transfer Plan) to the JSC. |
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4.3 | Continuing Know-How Transfer. Following the applicable Manufacturing Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound and the Initial Know-How Transfer for each Licensed Product, Blueprint will provide to the JPT in advance of its meeting [****] a summary of any additional Blueprint Manufacturing Know-How and other Blueprint Know-How, in each case, developed by Blueprint or its Affiliates or licensees since the previous quarterly summary that was provided to the JPT. Upon Zais reasonable request during the Term, Blueprint will (a) make available to Zai all Blueprint Manufacturing Know-How and other Blueprint Know-How, in each case, in Blueprints possession and not previously provided to Zai hereunder and that is necessary or reasonably useful for Zais Exploitation of any Blueprint Compound or Licensed Product (as applicable) in accordance with this Agreement, (b) provide a schedule of applicable Blueprint Manufacturing Patent Rights following delivery of a Manufacturing Technology Transfer Plan, (c) transfer any such Blueprint Know-How or Blueprint Manufacturing Know-How, or provide such schedule, to Zai no later than [****] after Zais request therefor, and (d) [****] after the Initial Know-How Transfer or Manufacturing Technology Transfer for a Blueprint Compound or Licensed Product (as applicable), provide Zai with reasonable access to Blueprint personnel involved in the Development or Manufacture of such Blueprint Compound or Licensed Product (as applicable) (and the corresponding Blueprint Compound), either in-person at Blueprints facility or by teleconference (the Continuing Know-How Transfer, and together with the Initial Know-How Transfer and the Manufacturing Technology Transfer, the Technology Transfers). Zai may only use the Blueprint Know-How to perform its obligations or exercise its rights under this Agreement and in accordance with the terms hereof. Notwithstanding anything to the contrary set forth in this Agreement, the terms of this Section 4.3 (Continuing Know-How Transfer) will not apply to any data or results of any Global Clinical Trial (including a Global Clinical Trial for a Licensed Product in a New Indication or for a Combination Product or Combination Regimen) unless [****] |
4.4 | Conduct of Technology Transfer. Blueprint personnel will not be obligated to travel to Zais (or its designees) facilities in connection with the performance of any Technology Transfer. Any materials provided by Blueprint to Zai in connection with the transfer of Blueprint Know-How (including pursuant to any Technology Transfer) will remain the sole property of Blueprint. |
4.5 | Technology Transfer Costs. Blueprint will provide consultation and assistance with qualified personnel in connection with the Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound as reasonably requested by Zai, subject to personnel availability. Blueprint will be responsible for the internal costs of up to [****] of such consultation and assistance for each Blueprint Compound. Zai will reimburse Blueprint for (a) internal costs (at the FTE Rate) in excess of [****] of such consultation and assistance for each Blueprint Compound and (b) all out-of-pocket costs, in each case ((a) and (b)), reasonably incurred by or on behalf of Blueprint in connection with such assistance within [****] after receiving Blueprints invoice therefor. |
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Article 5
DEVELOPMENT PROGRAM
5.1 | Global Development Plan. The global Development of Licensed Products that involves activities both inside and outside of the Territory will be conducted pursuant to a written Development plan (as updated from time to time in accordance with this Section 5.1 (Global Development Plan), the Global Development Plan). The initial Global Development Plan has been agreed by the Parties in writing on or prior to the Effective Date and is attached hereto as Schedule 5.1 (Global Development Plan). [****] With respect to the Licensed Products, the Global Development Plan will be consistent with the overall global development synopsis for each such Licensed Product provided by Blueprint to Zai prior to the Effective Date, and will include, as applicable to each Licensed Product, all Global Clinical Trials (including Clinical Trials that Blueprint has determined will include trial sites both inside and outside of the Territory) for the Licensed Products. Zai will support the global Development of each Licensed Product by conducting certain Development activities in the Territory as set forth in, and in accordance with, the Global Development Plan, including by satisfying the enrollment requirements for the Committed Trials as required under Section 5.2 (Enrollment in Global Clinical Trials). The Global Development Plan will include for each Licensed Product [****]. From time to time, Blueprint (or the JPT, with respect to any Blueprint/Zai Combination) may make and implement updates to the then-current Global Development Plan for one or more Licensed Products, including to contemplate the conduct of the Development of any Licensed Product for a New Indication or a new Combination Product or Combination Regimen. To the extent such amendments (i) are [****], and (ii) include activities to be conducted in the Territory, Blueprint will submit such proposed updates to the JSC for review and discussion before adopting such updates, provided, however, that if the updates to the Global Development Plan include [****] in the Territory, including any additional proposed Committed Trials, then such update must be approved by the JSC. |
5.2 | Enrollment in Committed Trials. |
5.2.1 | Enrollment in Committed Trials. Zai will, in accordance with the Global Development Plan for each Licensed Product, enroll and treat [****]. |
5.2.2 | Failure to Satisfy Patient Commitments. On a Committed Trial-by-Committed Trial basis, unless the Parties otherwise agree in writing, if Zai fails to enroll the Patient Commitment in such Committed Trial, other than due to [****] then Zai will reimburse Blueprint for [****]. Zai will pay each Shortfall Reimbursement to Blueprint within [****] after receiving Blueprints invoice therefor. For example, [****]. |
5.2.3 | Enrollment of Additional Patients in Committed Trials. If requested by Blueprint for one or more Committed Trials and agreed to by Zai, then Zai will enroll and treat additional patients in each such Committed Trial in excess of the Patient Commitment and Blueprint will reimburse Zai for [****]. Blueprint will pay each Excess Enrollment Reimbursement to Zai within [****] after receiving Zais invoice therefor. For example, [****] |
5.2.4 | Data Access Criteria. Subject to the terms of this Agreement, Blueprint and Zai will share in a timely fashion and allow the other Party to utilize data generated from each Partys on-going and future Clinical Trials and Regulatory Submissions for all Indications for the Licensed Products, including as set forth in Section 4.3 (Ongoing Know-How Transfer), Section 5.16 (Development Reports), Section 5.17 (Data Exchange and Use), and Section 6.4 (Right of Reference). [****] If Zai does not satisfy the criteria set forth in the foregoing clause (a) or (b), then Zai will not have any rights with respect to any data or results generated from such Global Clinical Trial for such Licensed Product, including pursuant to Section 4.3 (Ongoing Know-How Transfer), Section 5.17 (Data Exchange and Use) or pursuant to Section 6.4 (Right of Reference), except as necessary for Zai to comply with Applicable Law or safety reporting requirements of the applicable Regulatory Authorities in the Territory [****]. |
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5.3 | Zai Decision to Use a CRO. If Zai decides to engage a Development Subcontractor to perform one or more Clinical Trials with respect to Licensed Products in the Territory assigned to Zai under the Global Development Plan on Zais behalf, then, if applicable, Zai will [****] engaging a local Affiliate of the same contract research organization that Blueprint has engaged or plans to engage, in each case, to perform such Clinical Trials outside of the Territory (including if such Clinical Trial is a Committed Trials). |
5.4 | Territory-Specific Development Plans. Except for the activities allocated to Zai under the Global Development Plan for a Licensed Product pursuant to Section 5.1 (Global Development Plan), all Development of each Licensed Product in the Territory under this Agreement will be conducted pursuant to a written development plan for each such Licensed Product (each, as updated from time to time in accordance with this Section 5.4 (Territory-Specific Development Plans) and Section 3.2 (Joint Steering Committee), a Territory-Specific Development Plan). At least [****] prior to Zais planned initiation of any Development activities for a Licensed Product in the Territory that are not contemplated under the Global Development Plan, Zai will provide the applicable JPT with an initial draft of the Territory-Specific Development Plan for such Licensed Product for the JPTs review and comment. Each such Territory-Specific Development Plan will contain [****] (a) [****], (b) all major Clinical Development activities for such Licensed Product and all Territory-Specific Clinical Trials and the trial design thereof, in each case, to be conducted solely in furtherance of obtaining Regulatory Approval of such Licensed Product in the Territory (and not outside of the Territory) for the upcoming [****] period, (c) [****] timelines for achieving such activities described in (a) and (b), and (d) [****] key elements involved in obtaining Regulatory Approval of such Licensed Product from all applicable Regulatory Authorities throughout the Territory and the regulatory strategy for each Licensed Product for the Territory approved by the JSC pursuant to Section 6.1 (Regulatory Strategy). Each Territory-Specific Development Plan will include all Clinical Development required to obtain and maintain Regulatory Approval for the applicable Licensed Product in each region of the Territory. Zai will take the applicable JPTs comments [****] and incorporate such comments where appropriate prior to finalizing the initial Territory-Specific Development Plan for each Licensed Product. From time to time thereafter, [****] to include any New Territory-Specific Development Activities, Zai will propose updates to each Territory-Specific Development Plan in consultation with Blueprint through the applicable JPT and submit each initial Territory-Specific Development Plan and each such proposed updated Territory-Specific Development Plan to the JSC. The JSC will review, discuss, and determine whether to approve the initial Territory-Specific Development Plan for each Licensed Product and each update thereto. Once approved by the JSC, each update to a Territory-Specific Development Plan for a Licensed Product will become effective and supersede the then-current Territory-Specific Development Plan for such Licensed Product. |
5.5 | Development Diligence. Subject to the terms of this Agreement, Zai will be responsible for and will use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval, and, if applicable, Reimbursement Approval, for [****] each Licensed Product that is the subject of a Territory-Specific Development Plan or Global Development Plan in the Field in the Territory. Without limiting the generality of the foregoing, Zai will use Commercially Reasonable Efforts to [****]. |
5.6 | PRC Submission Estimated Timeline. |
5.6.1 | Other Licensed Products. [****] the Parties have finalized the PRC Submission Estimated Timeline [****], in each case, such PRC Submission Estimated Timeline is included in the initial Global Development Plan. In addition, the JPT will develop a PRC Submission Estimated Timeline for any additional Licensed Products at the appropriate time. The JPT will submit each such PRC Submission Estimated Timeline to the JSC to review, discuss, and determine whether to approve. |
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5.6.2 | Amendments and Obligations. The JPT will update, and will provide to the JSC to review, discuss, and determine whether to approve, the PRC Submission Estimated Timeline for each Licensed Product annually to include in detail the anticipated key regulatory activities for such Licensed Product [****] in the Territory and the dates on which such activities are estimated to occur. Without limiting the obligations set forth in Section 5.5 (Development Diligence), Zai will use Commercially Reasonable Efforts to: (a) make all Regulatory Submissions to the NMPA pursuant to and in accordance with Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals) for each Licensed Product and in accordance with the applicable PRC Submission Estimated Timeline (as may be amended by the JSC from time to time) [****] and (b) promptly obtain all approvals from the applicable Regulatory Authorities required to dose the first patient with each Licensed Product in Clinical Trials in the Territory. |
5.7 | Non-Clinical and Preclinical Studies. Blueprint will be responsible for [****] Non-Clinical Development for all Licensed Products, other than specific Non-Clinical Development for any Licensed Product that (a) is required specifically in support of [****] for such Licensed Product in the Territory, which additional Non-Clinical Development will, subject to approval by the JPT [****] be included under the Territory-Specific Development Plan for such Licensed Product or (b) that the JPT otherwise agrees to include in a Territory-Specific Development Plan, and in each case ((a) or (b)), for which Zai will be responsible (such Non-Clinical Development, Permitted Zai Non-Clinical Development). Notwithstanding any provision to the contrary set forth in this Agreement, in no event will the JPT be permitted to withhold consent to Zais performance of any specific Non-Clinical Development in the Territory that is required specifically in support of [****] for such Licensed Product in the Territory, unless[****]. Blueprint will provide support and cooperation as reasonably requested by Zai in connection with any such Permitted Zai Non-Clinical Development. In addition, Zai will provide support and cooperation as reasonably requested by Blueprint in connection with any Non-Clinical Development for any Blueprint/Zai Combination that is required to support [****] for such product outside of the Territory. The Party generating data and results (or on whose behalf such data and results are generated) in the course of conducting such Non-Clinical Development for any Licensed Product will provide such data and results to the other Party in accordance with Section 5.17 (Data Exchange and Use). |
5.8 | Proposed Blueprint/Zai Combination Products. |
5.8.1 | Proposed Combinations. If the JPT wishes to include, under the Global Development Plan, Development of any Blueprint/Zai Combination (each, a Proposed Blueprint/Zai Combination), then the JPT will develop a Global Development Plan for such Proposed Blueprint/Zai Combination, which plan will include the conduct of a POC Trial for such Proposed Blueprint/Zai Combination and a regulatory strategy for the applicable Proposed Blueprint/Zai Combination and the conduct those Clinical Trials contemplated in such Global Development Plan. Thereafter, the JPT will submit such plans, along with details regarding the scope of intellectual property rights relating to the applicable Active Ingredient Controlled by Zai or its Affiliates that will be licensed or sublicensed (as applicable) to Blueprint (where any license for Blueprint to obtain any right to any Zai Product beyond the conduct of Clinical Trials in accordance with this Section 5.8.1 (Proposed Combinations) will only be as contemplated under an agreement or amendment to this Agreement entered into by the Parties pursuant to Section 5.8.2 (Further Exploitation of Proposed Blueprint/Zai Combinations)), to the JSC for its review, discussion, and approval. |
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(a) | JSC Approval. If the JSC approves the Development under this Agreement of the applicable Proposed Blueprint/Zai Combination under the Global Development Plan, then [****]. |
(b) | No JSC Approval. If the JSC does not approve the Development under this Agreement of a Proposed Blueprint/Zai Combination, then such Proposed Blueprint/Zai Combination will not be a Blueprint/Zai Combination for purposes of this Agreement and the Parties may not Exploit such Proposed Blueprint/Zai Combination under this Agreement unless and until the JSC approves the Development such Proposed Blueprint/Zai Combination hereunder. |
5.8.2 | Further Exploitation of Proposed Blueprint/Zai Combinations. If the JSC determines to approve the conduct of a Pivotal Trial as a Global Clinical Trial for any Blueprint/Zai Combination that was a Proposed Blueprint/Zai Combination approved by the JSC pursuant to Section 5.8.1 (Proposed Blueprint/Zai Combinations), then: |
(a) | the JSC will determine which Party will conduct such Pivotal Trial as a Global Clinical Trial; |
(b) | following completion [****]; |
(c) | (i) Zai will not be required to grant any license to Blueprint to seek Regulatory Approval for, or Commercialize the Zai Product included in such Blueprint/Zai Combination, and (ii) Blueprint will not be required to grant any license to Zai to seek Regulatory Approval for, or Commercialize, the Blueprint Compound included in such Blueprint/Zai Combination, in each case ((i) and (ii)), unless the Parties reach agreement on the terms and conditions for such commercial arrangement under this Section 5.8.2 (Further Exploitation of Proposed Blueprint/Zai Combinations); |
(d) | notwithstanding any provision to the contrary set forth in this Agreement, no license will be deemed to have been granted to Blueprint or its Affiliates or (sub)licensees to Exploit any Zai Product, except that the license grant to Blueprint under Section 2.3 (License Grants to Blueprint) will include the right to Develop Blueprint/Zai Combinations solely through POC Trials if approved by the JSC pursuant to Section 5.8.1 (Proposed Combinations); |
(e) | the Parties will [****] reach agreement on such commercial arrangement prior to commencement of such Pivotal Trial or any further Development of such Blueprint/Zai Combination after completion of the POC Trial for such Blueprint/Zai Combination; and |
(f) | neither Party will conduct further Development or other Exploitation of the applicable Blueprint/Zai Combination inside or outside of the Territory, unless and until the Parties enter into a written agreement setting forth such terms as described above in Section 5.8.2(a) through Section 5.8.2(c). |
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5.9 | New Development Proposed by Zai. Notwithstanding Zais final decision-making authority with respect to Development activities for a Licensed Product that are Territory-specific as set forth in Section 3.7.2(b) (Zai Decisions), if [****], then, in either case ((a) or (b)), Zai will present to the JSC to review, discuss, and determine whether to approve, a proposal to add such Development activities for such New Indication or such New Combination to the Territory-Specific Development Plan for the applicable Licensed Product, including the regions in the Territory in which such activities would be conducted (a New Development Proposal). Each New Development Proposal will describe [****] the applicable Non-Clinical Development and Clinical Trials that Zai desires to conduct with respect to such New Indication or such New Combination, including [****] (the New Development Activities), as well as [****] anticipated to result from such New Development Activities, and [****]. |
5.9.1 | JSC Decision Regarding New Development Activities. The JSC will review, discuss, and determine whether to approve a New Development Proposal within [****] after receipt thereof from Zai. |
(a) | JSC Approval. If the JSC approves a New Development Proposal, then upon such an approval, (i) the New Development Activities set forth in such New Development Proposal will be New Territory-Specific Development Activities for purposes of this Agreement, and (ii) the JPT will update the Territory-Specific Development Plan for such Licensed Product to include such New Territory-Specific Development Activities for those regions in the Territory agreed by the JSC, including the proposed timelines, in each case, for such New Development Activities set forth in such New Development Proposal (as may be amended by the JSC upon such approval). Any New Territory-Specific Development Activities included in a Territory-Specific Development Plan pursuant to this Section 5.9.1(a) (JSC Approval) will be Development activities for all purposes under Section 5.5 (Development Diligence). |
(b) | No JSC Approval. If the JSC fails to approve a New Development Proposal, then upon such a failure, the New Development Activities proposed in the New Development Proposal will not be included in any Territory-Specific Development Plan and Zai will not perform any such New Development Activities. |
5.10 | Standard of Conduct. Each Party will perform, and will cause its Affiliates, sublicensees (or Sublicensees, as applicable), and subcontractors (or Subcontractors, as applicable) to perform, all Development activities for the Licensed Products under this Agreement (including under each Territory-Specific Development Plan and each Global Development Plan and any New Territory-Specific Development Activities) in good scientific manner, in a timely, professional manner, and in compliance with the applicable Territory-Specific Development Plan or Global Development Plan, as applicable, in accordance with GLP, cGMP, and GCP, as applicable, and in compliance with Applicable Law and with applicable FDA and EMA requirements to the extent necessary for the submission of data generated from such activities in Regulatory Submissions in the U.S. and the European Union. In addition, each Party will conduct its obligations with respect to any Global Clinical Trial under a Global Development Plan or (with respect to Zai) Territory-Specific Clinical Trial under a Territory-Specific Development Plan (as applicable) in strict adherence with the study design set forth in the applicable protocol therefor and as set forth in such Global Development Plan or such Territory-Specific Development Plan, each as may be amended from time to time, and will comply with each statistical analysis plan implemented by the other Party (as applicable) in connection therewith. Zai will not perform any Development of Blueprint Compounds or Licensed Products except for those activities set forth in a Territory-Specific Development Plan or set forth in, and allocated to Zai under, a Global Development Plan. |
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5.11 | New Development Proposed by Blueprint. At anytime during the Term, Blueprint may propose additional Committed Trials in addition to those identified on Schedule 1.60 (Committed Trials) by adding additional Global Clinical Trials for Licensed Products in New Indications or as new Combination Products or Combination Regimens (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials) to the Global Development Plan in accordance with Section 5.1 (Global Development Plan). |
5.11.1 | Zai Election Not to Sponsor. If the JSC does not approve the allocation of responsibility to Zai to serve as the Territory Sponsor or regulatory agent in the Territory for, or to otherwise implement in the Territory, such additional Global Clinical Trials added to the Global Development Plan by Blueprint for a Licensed Product for any New Indication or new Combination Product or Combination Regimen (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials), then: |
(a) | Not A Committed Trial. The proposed Global Clinical Trial will not be considered a Committed Trial under this Agreement and Zai will not be obligated to implement such Global Clinical Trials in the Territory; |
(b) | Right to Develop. Notwithstanding any provision to the contrary set forth in this Agreement (including the terms of Section 2.1 (License Grant to Zai)), Blueprint will have the right to implement such Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen globally (including in the Territory) [****]; and |
(c) | Zai Assistance. Zai will provide reasonable assistance to Blueprint to recruit and enroll patients from the Territory for such Global Clinical Trials [****]. |
5.11.2 | Patient Commitment for Data Access. If Zai wishes to be granted rights with respect to any data or results generated in such Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen added to the Global Development Plan by Blueprint (beyond the Indications, Combination Products, and Combination Regimens contemplated by the then-current Committed Trials), including pursuant to Section 4.3 (Continuing Know-How Transfer), Section 5.17 (Data Exchange and Use) or Section 6.4 (Right of Reference), then: (a) each Global Clinical Trial for such Licensed Product for such New Indication or such new Combination Product or Combination Regimen will be considered a Committed Trial for all purposes under this Agreement, (b) Zai will be obligated to satisfy the Patient Commitment with respect to all Global Clinical Trials for such Licensed Product for such New Indication or such new Combination Product or Combination Regimen, and (c) the terms of Section 5.2 (Enrollment in Global Clinical Trials) will apply to all Global Clinical Trials for such Licensed Product for such New Indication or for such new Combination Product or Combination Regimen. |
5.12 | Development of Co-Formulated Products. Unless otherwise agreed by the Parties, in the course of performing their obligations and exercising their rights under this Agreement, neither Party will (independently or for or with any Third Party) Develop any co-formulated pharmaceutical or biologic product that includes a Blueprint Compound together with any Zai Product. |
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5.13 | Responsibility for Development Costs. |
5.13.1 | Territory-Specific Development Costs. Except as otherwise set forth in this Agreement, [****]. |
5.13.2 | Global Development Costs. Except as otherwise set forth in this Agreement, and otherwise subject to Section 5.1 (Global Development Plan), Zai will be responsible for and will pay (a) all Third Party out-of-pocket costs [****] (b) all other costs and expenses [****], (c) costs of [****], and (d) the internal costs (at the FTE Rate) of Blueprint personnel incurred [****]. Blueprint will invoice Zai quarterly for the foregoing costs incurred by or on behalf of Blueprint in such Calendar Quarter, and Zai will pay the undisputed invoiced amounts within [****] after the date of any such invoice. |
5.13.3 | Shared Services. Zai will be responsible for and will pay [****] of the Shared Services Costs incurred by Blueprint in connection with any Committed Trials. Blueprint will invoice Zai quarterly for the foregoing costs incurred by or on behalf of Blueprint in each Calendar Quarter, and Zai will pay the undisputed invoiced amounts within [****] after the date of any such invoice. Blueprint will be responsible for and will pay [****] of the Shared Services Costs incurred by Zai in the performance of any Committed Trials, if any. Zai will invoice Blueprint quarterly for the foregoing costs incurred by or on behalf of Zai in each Calendar Quarter, and Blueprint will pay the undisputed invoiced amounts within [****] after the date of any such invoice. |
5.14 | Clinical Trial Audit Rights. |
5.14.1 | Conduct of Audits. Upon reasonable notification by Blueprint [****], Blueprint or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees, Subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees to perform Zais obligations under any Global Development Plan or Territory-Specific Development Plan, in each case, to ensure that the applicable Global Clinical Trials and Territory-Specific Clinical Trials are conducted in compliance with the applicable Global Development Plan or Territory-Specific Development Plan, GCP, and Applicable Law and meet Blueprints global Clinical Trial standards provided by Blueprint from time to time during the Term. [****] Blueprint will provide Zai with a written summary of Blueprints findings of any deficiencies or other areas of remediation that Blueprint identifies during any such audit. Zai will use Commercially Reasonable Efforts to remediate any such deficiencies within [****] following Zais receipt of such report[****]. Without limiting the foregoing, Zai will have the right to be present at any such audit conducted by Blueprint pursuant to this Section 5.14.1 (Conduct of Audits) of any Sublicensees, Subcontractors, or Clinical Trial sites. |
5.14.2 | Deficient Sites and Replacement. With respect to any Global Clinical Trial or Territory-Specific Clinical Trial, if either Party reasonably determines that any deficiencies with respect to a Clinical Trial site identified pursuant to Section 5.14.1 (Conduct of Audits) (each, a Deficient Site) may cause a Regulatory Authority to reject or otherwise deem deficient the Clinical Trial data from the conduct of any such Global Clinical Trial or Territory-Specific Clinical Trial (as applicable) at such Deficient Site, then such Party will notify the other Party of such Deficient Site and the Parties will discuss and attempt to agree upon a remediation plan for such Deficient Site. If the Parties cannot agree to such a remediation plan for a Deficient Site that is participating in a Global Clinical Trial, then Zai will promptly remove such Deficient Site from the applicable Global Clinical Trial or Territory-Specific Clinical Trial and replace such Deficient Site with a new Clinical Trial site (a Replacement Site) within the Territory[****] (unless not permitted by Applicable Law or for ethical reasons). Any such Replacement Site will be compliant in all respects with Applicable Law and Blueprints global Clinical Trial standards. |
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5.14.3 | Zai Audits. Zai will provide Blueprint with copies of all quality oversight or audit reports prepared in connection with any audit that Zai or its Affiliates or Sublicensees conduct of any Sublicensee, Subcontractor, or Clinical Trial site that Zai or its Affiliates or Sublicensees have engaged or are evaluating to potentially engage to fulfill Zais obligations under a Global Development Plan or a Territory-Specific Development Plan no later than [****] after receiving or preparing any such report (as applicable), including English translations thereof. If Blueprint believes in good faith that any such quality oversight or audit report may be necessary in connection with obtaining, supporting, or maintaining one or more Regulatory Approvals for a Licensed Product or for other communications with Regulatory Authorities outside of the Territory, then upon Blueprints request, Zai will provide a certified translation thereof [****]. |
5.15 | Development Records. Zai will, and will cause its Affiliates, Sublicensees, and Subcontractors to, maintain reasonably complete, current, and accurate records of all Development activities conducted by or on behalf of Zai, and its Affiliates, Sublicensees, and Subcontractors, respectively, pursuant to this Agreement and all data and other information resulting from such activities consistent with its usual practices, in validated computer systems that are compliant with 21 C.F.R. §11 and in accordance with Applicable Law of both the United States and the Territory. [****] Zai will maintain all such records relating to the Development of Licensed Products for a period of [****]. Such records will fully and properly reflect all work done and results achieved in the performance of the Development activities for the Licensed Products in good scientific manner appropriate for regulatory and patent purposes. Zai will document all Non-Clinical Development and Clinical Trials in formal written study reports in accordance with GLP, cGMP, and GCP, as applicable, and in compliance with Applicable Law. Upon Blueprints reasonable request, not more frequently than [****] during which Zai or its Affiliates, Sublicensees, or Subcontractors are performing or having performed Development activities for any Licensed Product, Zai will, and will cause its Affiliates, Sublicensees, and Subcontractors to, allow Blueprint to access, review, and copy such records (including access to relevant databases). Blueprint will have the right to use the data and results generated by or on behalf of Zai and its Affiliates, Sublicensees, and Subcontractors hereunder to Exploit the Blueprint Compounds and Licensed Products outside of the Territory and to perform Development activities under a Global Development Plan that are allocated to Blueprint thereunder. Each Party will ensure that all records or other documents that it transmits to the other Party electronically under this Agreement are transmitted over secure systems that include adequate encryption safeguards to prevent unauthorized access and maintain data security. |
5.16 | Development Reports. No later than [****] during which Zai is performing, or having performed, Development activities for any Licensed Product, Zai will provide Blueprint[****] with [****] written reports [****] the Development activities performed during the period since the preceding report, the Development activities in process, and the future activities that Zai or its Sublicensees or Subcontractors expect to initiate, including a summary of the data, timelines, and results of such Development activities. Such reports will be in English. Zai will also establish a secure link that includes adequate encryption safeguards to provide Blueprint with electronic access to, and secure file transfer of, such information. Without limiting the foregoing, such reports will contain sufficient detail to enable Blueprint to assess Zais compliance with its Development diligence obligations set forth in Section 5.5 (Development Diligence). Zai will [****] respond to Blueprints [****] requests from time to time for additional information regarding significant Development activities for any Licensed Product performed by or on behalf of Zai or its Affiliates, Sublicensees, or Subcontractors. The Parties will discuss the status, progress, and results of all Development activities at each JSC meeting. Such reports will be the Confidential Information of Zai and subject to the terms of Article 11 (Confidentiality; Publication). |
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5.17 | Data Exchange and Use. Subject to Section 5.2.4 (Data Access Criteria) and Section 5.8.1(a) (JSC Approval), in addition to its adverse event and safety data reporting obligations set forth in Section 6.5 (Adverse Events Reporting), each Party will [****] provide the other Party with copies of all data and results and all supporting documentation (e.g., protocols, investigators brochures, case report forms, and analysis plans) Controlled by such Party that are generated by or on behalf of such Party or its Affiliates, Sublicensees, or Subcontractors, if applicable, in the Development of each Licensed Product or any Companion Diagnostic, provided, however, that Blueprint may decline to receive copies of data and results of Development of a Blueprint/Zai Combination Product or other Combination Product or Combination Regimen. Zai will have the right to use and reference such data and results provided by Blueprint for the purpose of obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approval, as applicable, of the Licensed Products and Companion Diagnostics in the Territory, without additional consideration. Blueprint and its designees will have the right to use and reference such data and results provided by Zai for the purpose of obtaining, supporting, or maintaining Regulatory Approval or any Reimbursement Approval, as applicable, of any Licensed Product or Companion Diagnostic (a) outside of the Territory during the Term, or (b) anywhere in the world following termination of this Agreement, in each case ((a) and (b)), without additional consideration. |
5.18 | Development of Companion Diagnostics. In connection with the Development or Commercialization of any Licensed Product for which the JSC has approved a Territory-Specific Development Plan (as applicable) contemplating the Development of one or more companion diagnostic products to be used in connection with such Licensed Product (each a Companion Diagnostic), Zai may elect to Develop one or more Companion Diagnostics solely in the Territory. Unless otherwise allocated to Zai under a Global Development Plan for a Licensed Product, Blueprint will be responsible for Developing Companion Diagnostics for Licensed Products if such Companion Diagnostics are to be used with one or more Licensed Products inside and outside of the Territory. If JSC determines that Zai will Develop a Companion Diagnostic for use with the Commercialization of any Licensed Product in the Territory, then Zai will be responsible [****]. Without limiting Zais reimbursement obligations under Section 5.13 (Responsibility for Development Costs) (which obligations pertain to the Development of each Licensed Product, including the cost to purchase Companion Diagnostics [****] to screen patients in connection with the Development of such Licensed Products), Blueprint will be responsible for [****] Notwithstanding Blueprints responsibility for [****] if Zai wishes to use any Companion Diagnostic Developed by Blueprint in connection with Zais Commercialization of any Licensed Product in the Territory, then Zai will reimburse Blueprint for: (a) [****] that are related to the Development of Companion Diagnostics for use with a Licensed Product solely in the Territory [****] and (b) with respect to [****] that are related to the Development of Companion Diagnostics for use [****] the Territory [****]. |
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Article 6
REGULATORY
6.1 | Regulatory Strategy. [****] the JPT will discuss and develop a regulatory strategy for the Territory for each Licensed Product and will submit the same to the JSC to review, discuss, and determine whether to approve. From time to time the JPT may update the regulatory strategy for the Territory for any Licensed Product and submit the same to the JSC to review, discuss, and determine whether to approve. Once approved by the JSC, each update to a regulatory strategy for such a Licensed Product will become effective and supersede the then-current regulatory strategy for the Territory for such Licensed Product and such approved regulatory strategy will be included in the Territory-Specific Development Plan. The Parties will reasonably coordinate with respect to the implementation of the regulatory strategy for each Licensed Product in the Territory. |
6.2 | Zais Regulatory Responsibilities. |
6.2.1 | Obtaining and Maintaining Regulatory Approvals. Each Party will keep the other Party informed of regulatory developments related to the Licensed Products in each region in the Territory and will promptly notify the other Party in writing of any decision by any Regulatory Authority in the Territory regarding any Licensed Product. |
(a) | In the PRC. Prior to [****], Zai or one of its Affiliates will be responsible for undertaking all regulatory activities and interactions with Regulatory Authorities in the PRC for such Licensed Product in Blueprints name as the express and authorized regulatory agent of record for Blueprint in the Territory and will take such actions on behalf of and for the benefit of Blueprint in the PRC in accordance with the applicable regulatory strategy approved by the JSC (including performing any and all regulatory activities assigned to Zai in this Agreement or by the JSC during the Term in connection with the Development or Commercialization of a Licensed Product in the Territory). Following [****] Zai or one of its Affiliates will be responsible for all regulatory activities and interactions with Regulatory Authorities in the PRC leading up to and including obtaining (to the extent not already obtained) and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for such Licensed Product in the PRC in Zais or its Affiliates own name in accordance with the applicable regulatory strategy approved by the JSC. Prior to undertaking any such activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals, Regulatory Approvals, or Reimbursement Approvals for any Licensed Product in the PRC, whether prior to or after [****] for the applicable Licensed Product, Zai will submit a [****] plan for undertaking the same to the JSC for review and discussion. Following [****] Zai or one of its Affiliates will continue to be responsible for all regulatory activities and interactions with Regulatory Authorities in the PRC with respect to any imported version of such Licensed Product as the express and authorized regulatory agent of record for Blueprint in the PRC and will continue to take such actions with respect to the imported Licensed Product on behalf of and for the benefit of Blueprint in the PRC in accordance with the applicable regulatory strategy approved by the JSC. |
(b) | Obtaining and Maintaining Regulatory Approvals outside the PRC. Zai will be responsible for all regulatory activities with respect to Licensed Products leading up to and including obtaining, and thereafter maintaining, Regulatory Approvals and any Reimbursement Approvals in all regions of the Territory other than the PRC in its own name or in the name of its Affiliate, Sublicensee, or Third Party Distributor, in each case, in accordance with the regulatory strategy approved by the JSC. |
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6.2.2 | Consultation with NMPA. If Blueprint determines in its reasonable discretion that a consultation meeting with the NMPA may be necessary to conduct any Development of Licensed Products in the Territory contemplated under this Agreement, then at Blueprints reasonable request, Zai will request a consultation meeting with the NMPA to discuss such Development in advance of commencing such Development. In such event, the Parties will coordinate with each other regarding the contents of any materials to be shared with the NMPA in connection with such meeting. |
6.2.3 | Review of Regulatory Submissions. Zai will provide to Blueprint for review and comment drafts of all Regulatory Submissions in the Territory for the Licensed Products. Zai will incorporate any [****] comments received from Blueprint on such Regulatory Submissions. In addition, each Party will notify the other Party of any Regulatory Submissions for the Licensed Products and any comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Territory and will provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [****] after submission or receipt thereof (or such longer time period as may be necessary to obtain translations thereof). If any such Regulatory Submission, comment, or correspondence is not in English, then Zai will provide Blueprint with a certified English translation [****] after receipt of such Regulatory Submission, comment, or correspondence[****]. Blueprint will have the right to review and comment on all such Regulatory Submissions, and Zai will [****] and incorporate such comments [****] |
6.2.4 | Notice of Meetings. Each Party will provide the other Party with notice of any meeting or discussion with any Regulatory Authority in the Territory related to any Licensed Product no later than [****] after receiving notice thereof [****] Zai will lead any such meeting or discussion and Blueprint or its designee will have the right, but not the obligation, to attend and participate in any such meeting or discussion unless prohibited or restricted by Applicable Law or Regulatory Authority. At Zais request, Blueprint will reasonably cooperate with Zai in preparing for any such meeting or discussion. If Blueprint elects not to attend such meeting or discussion, then Zai will provide to Blueprint a written summary thereof in English [****] following such meeting or discussion. |
6.2.5 | Zai Responsibility for Costs and Expenses. Zai will be responsible for all costs and expenses incurred in connection with the performance of all regulatory activities leading up to and including obtaining and thereafter maintaining, Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for each Licensed Product from Regulatory Authorities in the Territory. |
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6.3 | Blueprints Regulatory Responsibilities. Other than with respect to a locally-Manufactured version of a Licensed Product following [****] therefor (if applicable), Blueprint will own and hold all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals, as applicable, for all Licensed Products in the PRC, and upon Zais reasonable request Blueprint will provide Zai with access to and copies of the applicable Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for such Licensed Products in the PRC. Following [****] with respect a locally-Manufactured version of a Licensed Product, Zai will own and hold the Local Manufacturing Approvals, Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals, as applicable, for such locally-Manufactured version of such Licensed Product (and any Combination Regimen of which such Licensed Product is a part) in the PRC, and upon Blueprints reasonable request Zai will provide Blueprint with access to and copies of the applicable Local Manufacturing Approvals, Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals for such locally-Manufactured version of such Licensed Product (and each Combination Regimen of which it is a part) in the PRC. For clarity, following [****], Blueprint will continue to own and hold the IDL and other Regulatory Submissions, Regulatory Approvals, and other approvals and authorizations in the PRC, as applicable, with respect to imported Licensed Products. Subject to Section 5.2.4 (Data Access Criteria) and Section 5.8.1(a) (JSC Approval), Blueprint will reasonably cooperate with Zai in obtaining any Regulatory Approvals and any Reimbursement Approvals, as applicable, for each Licensed Product in the Territory by providing access to Regulatory Approvals, Regulatory Submissions, clinical data, and other data, information, and documentation for the Licensed Products, both inside and outside of the Territory, in each case, to the extent Controlled by Blueprint. Zai [****] in connection with providing any such access or further assistance to Zai. |
6.4 | Right of Reference. Subject to Section 5.2.4 (Data Access Criteria) and Section 5.8.1(a) (JSC Approval), each Party will grant, and hereby does grant, to the other Party and its Affiliates, licensees, and Sublicensees a right of reference to all Regulatory Submissions pertaining to the Licensed Products in the Field submitted by or on behalf of such Party or its Affiliates, including any Zai Product as necessary in relation to any Blueprint/Zai Combination. Subject to Section 5.8.1(b) (No JSC Approval), Section 5.8.2 (Further Exploitation of Proposed Additional Blueprint/Zai Combinations that are Blueprint/Zai Combinations), and Section 5.11 (New Development Proposed by Blueprint), Zai and its Affiliates and Sublicensees may use such right of reference to Blueprints Regulatory Submissions solely for the purpose of seeking, obtaining, supporting, and maintaining Local Manufacturing Approvals, Regulatory Approvals, and any Reimbursement Approvals, as applicable, for the applicable Licensed Product in the Field in the Territory, as Blueprints authorized regulatory agent of record, or on its own behalf for a locally-Manufactured version of a Licensed Product following [****] for such Licensed Product. Subject to Section 5.8.1(b) (No JSC Approval) and Section 5.8.2 (Further Exploitation of Proposed Additional Blueprint/Zai Combinations that are Blueprint/Zai Combinations), Blueprint and its Affiliates, licensees, and Sublicensees may use such right of reference to Zais Regulatory Submissions, if any, solely for the purpose of seeking, obtaining, supporting, and maintaining Regulatory Approval and any Reimbursement Approvals of Licensed Products outside of the Territory. Each Party will bear its own costs and expenses associated with providing the other Party with the right of reference pursuant to this Section 6.4 (Right of Reference). Each Party will take such actions as may be reasonably requested by the other Party to give effect to the intent of this Section 6.4 (Right of Reference) and to give the other Party the benefit of the granting Partys Regulatory Submissions in the other Partys territory as provided herein. Such actions may include (a) providing to the other Party copies of correspondence and communications received from the applicable Regulatory Authorities related to such Partys application for Regulatory Approval of the Licensed Products in the Territory or outside of the Territory, as applicable, or (b) providing the other Party with any underlying raw data or information submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Submissions Controlled by such granting Party or its Affiliates that relates to any Licensed Product. |
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6.5 | Adverse Events Reporting. |
6.5.1 | Safety Agreements. [****] the Parties will enter into one or more written agreements setting forth worldwide safety and pharmacovigilance procedures for the Parties with respect to each Licensed Product (each a Safety Agreement). Each Safety Agreement will describe the obligations of both Parties with respect to the coordination of collection, investigation, reporting, and exchange of information between the Parties concerning any adverse event experienced by a subject or, in the case of non-clinical studies, an animal in a toxicology study, and the seriousness thereof, whether or not determined to be attributable to any Blueprint Compound or Licensed Product, including any such information received by either Party from a Third Party (subject to receipt of any required consents from such Third Party) and will be sufficient to permit each Party and its Affiliates, licensees, or Sublicensees (as applicable) to comply with its legal obligations with respect thereto, including each Partys obligations as the owner or holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the Territory or outside the Territory, as applicable. Each Safety Agreement will also detail each Partys responsibilities with respect to recalls and withdrawals of the applicable Licensed Product inside and outside of the Territory. If required by changes in Applicable Law, then the Parties will make appropriate updates to the applicable Safety Agreements. Each Party will comply with its respective obligations under each Safety Agreement and cause its Affiliates, licensees, and Sublicensees to comply with such obligations. Each Party will notify the other Party of any new planned Clinical Trials for any Licensed Product and the Parties will update the Safety Agreement to the extent necessary to comply with any applicable requirements set forth under Applicable Law or of any Regulatory Authorities related to adverse event reporting, drug safety, patient safety, pharmacovigilance, and risk management. Notwithstanding anything to the contrary in this Agreement or the Safety Agreement, each Party and its Affiliates, licensees, and Sublicensees will have the right to disclose information related to the safety of one or more Blueprint Compounds or Licensed Products to the extent that such disclosure is required for such Party to comply with its obligations under Applicable Law or the safety requirements of the applicable Regulatory Authorities. To the extent that there is a conflict between the terms of this Agreement and the terms of any Safety Agreement, the terms of the applicable Safety Agreement will govern with respect to the subject matter set forth therein. |
6.5.2 | Safety Databases. Zai will maintain a safety database in English for Clinical Trials for the Licensed Products conducted in the Territory under a Territory-Specific Development Plan[****]. During such time that Blueprint is the holder of Regulatory Approvals and Regulatory Submissions for a Licensed Product in the Territory, Zai will be responsible for, on Blueprints behalf: (a) reporting to the applicable Regulatory Authorities in the Territory all quality complaints, adverse events, and safety data related to such Licensed Product for all Territory-Specific Clinical Trials or Global Clinical Trials conducted in the Territory; and (b) responding to safety issues and to all requests of Regulatory Authorities related to such Licensed Product in the Territory. Zai will provide Blueprint (i) secure, real-time access to Zais safety database for the Licensed Products in the Territory, and (ii) upon Blueprints request, query results from Zais worldwide safety database for each Zai Product solely for the purpose of Developing Blueprint/Zai Combinations. Blueprint will maintain a global safety database for Global Clinical Trials for the Licensed Products conducted under each Global Development Plan [****]. |
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6.5.3 | Notification Obligations. Without limiting the provisions of Section 6.5.1 (Safety Agreements), Zai will be responsible for complying with all Applicable Law governing adverse events (including the reporting thereof) in the Territory and will comply fully with all applicable adverse event reporting recommendations and requirements in all regions in the Territory where Zai intends to Commercialize the applicable Licensed Product. Zai will notify Blueprint on a timely basis of any adverse events related to one or more Licensed Products occurring in the Territory. Zai will submit copies of reports of adverse events related to the Licensed Products to Blueprint simultaneously with submission thereof to the applicable Regulatory Authorities in the Territory, including any single case reports, together with an appropriate medical evaluation, as well as aggregate data, such as Periodic Safety Update Reports (PSURs) required by authorities. Each Party will notify the other in a timely manner and in any event [****] (or such shorter period as may be required for a Party to comply with its obligations under Applicable Law) of receiving any (a) serious adverse event reports from Clinical Trials for a Licensed Product that the applicable Party is monitoring, (b) notice from a Regulatory Authority, independent review committee, data safety monitoring board, or another similar clinical trial or post-marketing monitoring body alleging significant concern regarding a patient safety issue related to a Licensed Product, or (c) other material information relevant to the safety or efficacy of any Licensed Product. |
6.6 | Regulatory Audits. In addition to its rights to conduct audits pursuant to Section 5.14 (Clinical Trial Audit Rights), upon reasonable notification, Blueprint or its representatives will be entitled to conduct audits of safety and regulatory systems, procedures, or practices of Zai or its Affiliates, Sublicensees, or Subcontractors (including Clinical Trial sites) relating to any Licensed Product. With respect to any inspection of Zai or its Affiliates, Sublicensees or Subcontractors (including Clinical Trial sites) by any Governmental Authority relating to any Licensed Product, Zai will notify Blueprint of such inspection (a) no later than [****] after Zai receives notice of such inspection [****] or (b) within [****] after the completion of any such inspection of which Zai did not receive prior notice. Zai will promptly provide Blueprint with all information related to any such inspection. To the extent permitted by Applicable Law, Zai will also permit Governmental Authorities outside of the Territory to conduct inspections of Zai or its Affiliates, Sublicensees, or Subcontractors (including Clinical Trial sites) relating to any Licensed Product, and will ensure that all such Affiliates, Sublicensees, and Subcontractors permit such inspections. Blueprint will have the right, but not the obligation (unless required by Applicable Law or any Governmental Authority), to be present at any such inspection. Following any such regulatory inspection related to one or more Licensed Products, Zai will provide Blueprint with (i) an unredacted copy of any findings, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to a Licensed Product) within [****] of Zai receiving the same, and (ii) an English translation of any findings, notice, or report of a Governmental Authority related to such inspection (to the extent related to a Licensed Product) within [****] after receiving the same [****]. |
6.7 | No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to a Licensed Product in such other Partys territory that could [****] of any Licensed Product in such Partys territory, then such Party will have the right to bring the matter to the attention of the JSC and the JSC will [****]. Without limiting the foregoing, unless the Parties otherwise agree (or unless otherwise set forth in this Agreement or in the applicable Global Development Plan), neither Party will communicate with any Regulatory Authority having jurisdiction outside of its respective territory with respect to any Licensed Product, unless for the purpose of seeking Regulatory Approval or so ordered by such Regulatory Authority, in which case, such Party will immediately notify the other Party of such order. |
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6.8 | Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai relating to any Licensed Product, then Zai will notify Blueprint of such contact, inspection, notice, or action within [****] after receipt of such notice (or, if action is taken without notice, within [****] of Zai becoming aware of such action). If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Blueprint relating to any Licensed Product that is reasonably likely to have a material adverse impact on Zais activities with respect to the Licensed Product in the Territory, then Blueprint will notify Zai of such contact, inspection, notice, or action within [****] after receipt of such notice (or, if action is taken without notice, within [****] of Blueprint becoming aware of such action), provided that, except to the extent disclosure is required pursuant to Applicable Law, Blueprint will not be required to disclose any information that is subject to a confidentiality restriction and will not be required to delay any response or action as a result of such notification requirement. Blueprint will have the final decision-making authority with respect to [****], but and will consider Zais reasonable comments to such responses. Zai will have the final decision-making authority with respect to [****], but will incorporate Blueprints reasonable comments to any such responses. [****] Upon Zais request, Blueprint will provide an update on material regulatory actions taken with respect to the Licensed Products outside the Territory at regularly scheduled meetings of the JSC. |
6.9 | Notice of Other Actions. In addition, each Party will promptly notify the other of any information that it receives regarding any threatened or pending action, inspection, or communication by or from a Third Party that would reasonably be expected to materially affect the Development of the Licensed Products. |
Article 7
MANUFACTURING
7.1 | Supply by Blueprint. |
7.1.1 | Development Supply. [****] the Parties will enter into a clinical supply agreement for the supply to Zai of Licensed Products containing each Blueprint Compound (together with the corresponding quality agreement, each a Clinical Supply Agreement) pursuant to which Zai will purchase from Blueprint its requirements of each such Licensed Product [****] as necessary for Zai to fulfill its obligations under this Agreement related to the Development of Licensed Products. [****] Pursuant to each Clinical Supply Agreement: |
(a) | Sole Supply. Blueprint will, subject to Section 7.2 (Supply by Zai) and any right for Zai to procure its own supply as set forth in such Clinical Supply Agreement, have the sole right to, either by itself or through a CMO, Manufacture and supply to Zai all Blueprint Compounds and Licensed Products containing such Blueprint Compounds, required by Zai for Development use in the Territory as set forth in a Territory-Specific Development Plan and to perform Zais Development responsibilities under a Global Development Plan [****]. |
(b) | Supply Price. Blueprint will supply the Blueprint Compounds and Licensed Products to Zai pursuant to this Section 7.1.1 (Development Supply) at a transfer price equal to [****], and Zai will pay such invoice, based on a payment schedule to be set forth in the Clinical Supply Agreement and in accordance with Section 7.1.3 (Shipment and Delivery). |
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7.1.2 | Commercial Supply. [****] the Parties will enter into a commercial supply agreement (together with the corresponding quality agreement, the Commercial Supply Agreement), for the supply to Zai of (a) the [****] of each Licensed Product or such other form of such Licensed Product as the JSC may agree, in either case, until [****], and (b) until [****] Licensed Product, pursuant to which Zai will purchase from Blueprint its requirements of the same as necessary for Zai to fulfill its obligations under this Agreement related to the Manufacture and Commercialization of each Licensed Product in the Territory. Notwithstanding the entrance into any Commercial Supply Agreement, [****]. The Parties may also elect to amend the terms of a Commercial Supply Agreement into which the Parties have entered to contemplate the commercial supply to Zai of one or more additional Licensed Products in lieu of entering into a separate Commercial Supply Agreement for such Licensed Product. [****] Pursuant to all Commercial Supply Agreements for Licensed Products in the Territory: |
(a) | Sole Supply. Subject to Section 7.2 (Supply by Zai) and any right for Zai to procure its own supply as set forth in such Commercial Supply Agreement, Blueprint will have the sole right to, either by itself or through an Affiliate, CMO, or licensee, Manufacture and supply to Zai all such Licensed Products as required by Zai for Commercialization in the Territory in accordance with this Agreement. The Commercial Supply Agreement will [****]. |
(b) | Supply Price. Blueprint will supply to Zai pursuant to this Section 7.1.2 (Commercial Supply) each Licensed Product (or Active Ingredient thereof, as applicable) at a transfer price equal to [****]. Blueprint will invoice Zai for such Licensed Products, and Zai will pay such invoice, based on a payment schedule to be set forth in the Commercial Supply Agreement and in accordance with Section 7.1.3 (Shipment and Delivery). |
7.1.3 | Shipment and Delivery. Delivery of all Blueprint Compounds and Licensed Products supplied by Blueprint under any Clinical Supply Agreement or Commercial Supply Agreement will take place [****]. |
7.2 | Supply by Zai. |
7.2.1 | Restriction on Manufacturing by Zai. Zai will not Manufacture or have Manufactured any Blueprint Compound or any Licensed Product that contains such Blueprint Compound until the completion of a Manufacturing Technology Transfer for the applicable Blueprint Compound in accordance with Section 4.2 (Manufacturing Technology Transfer). Notwithstanding any provision to the contrary in this Agreement, unless otherwise subsequently agreed by Blueprint in a Clinical Supply Agreement or Commercial Supply Agreement, or otherwise in writing, in no event will Zai perform any step in the Manufacturing process for any Licensed Product [****]. |
7.2.2 | Clinical and Commercial Supply. Following [****], Zai will Manufacture locally-Manufactured Licensed Products in the Territory for Development purposes or commercial use, as applicable, and will be responsible for all Manufacturing steps transferred to Zai under a Manufacturing Technology Transfer Plan, in each case, in the Territory [****]. Zai agrees that Zais Manufacturing process with respect to each locally-Manufactured Licensed Product will at all times be in accordance with the Zai Specifications for such Licensed Product approved by Blueprint pursuant to Section 7.2.3 (Specifications) and cGMP and ICH Guidelines, and in compliance with Applicable Law. |
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7.2.3 | Specifications. Unless the JSC determines that Zai will be granted rights only to package and label, but not otherwise Manufacture, a particular Licensed Product for Development or Commercialization purposes in the Territory, as part of the Manufacturing Technology Transfer for each Blueprint Compound and the Licensed Products containing such Blueprint Compound, Blueprint will provide Zai with Blueprints written process and quality specifications for the Manufacturing drug product of such Licensed Product (the Blueprint Specifications). Zai will prepare written process and quality specifications for the Manufacture of drug product of such Licensed Products applicable to Zais Manufacturing facilities, systems, processes, and capabilities, including how the foregoing relate to drug substance, drug product, in-process intermediates, raw materials, and reference material (the Zai Specifications), which Zai Specifications will be consistent in all respects with the Blueprint Specifications for such Licensed Product, unless the requirements of any Regulatory Authority or Applicable Law in the Territory necessitate any deviations from such Blueprint Specifications. Zai will provide to Blueprint all such Zai Specifications (and any subsequent changes thereto) for Blueprints review, comment and approval. In addition, Zai will promptly provide to Blueprint for its review and approval any changes to the Zai Specifications for any Licensed Product at any time following Blueprints approval of the Zai Specifications for such Licensed Product, and will provide such proposed amendment to Blueprint for Blueprints review, comment and approval in accordance with the procedure described below. [****] Blueprint will either (a) approve the Zai Specifications for such Licensed Product (or any changes thereto), or (b) provide Zai with a written response to the Zai Specifications for such Licensed Product (or such changes thereto) that includes a description of any deficiencies or limitations that Blueprint has identified with respect thereto, and the Parties will cooperate to develop a plan for remediation with respect to any such deficiencies or limitations within a reasonable period of time thereafter. Following Zais remediation of all deficiencies, Zai will provide Blueprint with a revised draft of the Zai Specifications for the applicable Licensed Product (or any subsequent changes to any Zai Specifications) for Blueprints review and approval. Thereafter, and on a continuing basis for so long as Zai Manufactures a particular Licensed Product, Zai will (i) Manufacture and require its Affiliates and CMOs to Manufacture such Licensed Product is at all times in accordance with the Blueprint-approved Zai Specifications for such Licensed Product and cGMP and ICH Guidelines, and (ii) complete any additional studies or testing required to maintain any qualifications and Regulatory Approvals (including manufacturing licenses) from any Regulatory Authorities or other Governmental Authorities necessary to continue to Manufacture such Licensed Product in the Territory and provide to Blueprint copies of reports from any such additional studies or testing in English[****]. |
7.2.4 | Second Source of Supply. Blueprint will have the right at any time during the Term to request that Zai serve as a back-up supplier of one or more Licensed Products for use by Blueprint inside or outside of the Territory. Upon Blueprints request, and Zais agreement, following completion of the Manufacturing Technology Transfer with respect to a Blueprint Compound and the Licensed Products containing such Blueprint Compound, Zai will supply such Licensed Products to Blueprint for Blueprints Exploitation of such Licensed Products outside of the Territory, as a second source of supply, at a price equal to [****]. |
7.3 | Product Tracking in the Territory. Zai will, and will ensure that its Affiliates and Sublicensees, maintain adequate records to permit the Parties to trace the distribution, sale, and use of all Licensed Products to hospitals and pharmacies in the Territory. |
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Article 8
MEDICAL AFFAIRS
8.1 | Medical Affairs Plans. [****] Zai will develop and provide an initial draft of the Medical Affairs Plan for such Licensed Product to the JPT for its review and discussion. The Medical Affairs Plan for a Licensed Product will contain a [****] of the major Medical Affairs activities to be undertaken for such Licensed Product in the Territory and the estimated timelines for performing such activities, including all key opinion leaders that Zai plans to engage. The JPT will have the right to comment on each such Medical Affairs Plan and each update thereto, and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Medical Affairs Plan (or any update thereto). Thereafter, from time to time, [****] Zai will propose updates to the Medical Affairs Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including to account for relevant factors that may influence such plan and the Medical Affairs activities set forth therein. Zai submit each initial Medical Affairs Plan and each such proposed updated Medical Affairs Plan to the JSC. The JSC will review, discuss, and determine whether to approve each initial Medical Affairs Plan for each Licensed Product and each update thereto. Once approved by the JSC, each update to a Medical Affairs Plan for a Licensed Product will become effective and supersede the then-current Medical Affairs Plan for such Licensed Product. |
8.2 | Conduct of Medical Affairs Activities. Zai will conduct all Medical Affairs activities for Licensed Products in the Territory in accordance with the applicable Medical Affairs Plan. Zai will not conduct any Medical Affairs activities with respect to Licensed Products except for those activities set forth in an applicable Medical Affairs Plan. Zai will, subject to Applicable Laws, conduct such activities in compliance with its internal policies on engaging and sponsoring healthcare providers. |
8.3 | Medical Affairs Reports. For each Calendar Year following the first Regulatory Approval for a Licensed Product in the Territory, [****] Zai will provide to Blueprint a report (by means of a slide presentation or otherwise) summarizing the Medical Affairs activities performed by or on behalf of Zai and its Affiliates and Sublicensees in the Territory for each Licensed Product in each region in the Territory since the prior report provided by Zai. Such reports will be Confidential Information of Zai and subject to the terms of Article 11 (Confidentiality; Publication). Zai will provide [****] updates [****] to any such report at each meeting of the JSC, JPT, and any Working Group established by the JSC to oversee Medical Affairs activities under this Agreement. |
8.4 | Coordination of Medical Affairs Activities. The Parties recognize that each Party may benefit from the coordination of certain Medical Affairs activities for the Licensed Products inside and outside of the Territory. Accordingly, the Parties will coordinate such activities through the JPT where appropriate, including to ensure that medical information provided by each Party in their respective territories is consistent inside and outside of the Territory. Upon Zais request, Blueprint will provide an update on Blueprints material planned key Medical Affairs activities with respect to the Licensed Products outside the Territory at regularly scheduled meetings of the JSC. |
Article 9
COMMERCIALIZATION
9.1 | Commercialization Diligence Obligations. Zai will be solely responsible for and will use Commercially Reasonable Efforts to Commercialize each Licensed Product in each region in the Territory after receiving Regulatory Approval and, if applicable, Reimbursement Approval for such Licensed Product in such region. Zai will conduct all Commercialization of each Licensed Product in the Territory in accordance with the Commercialization Plan for such Licensed Product, at its sole cost and expense. [****] |
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9.2 | Commercialization Plans. [****] Zai will develop and provide an initial draft of the Commercialization Plan for such Licensed Product to the JPT for its review and discussion. The Commercialization Plan for a Licensed Product will contain [****] Commercialization activities to be undertaken (including [****]) for such Licensed Product in the Territory and the estimated timelines for achieving such activities. The JPT will have the right to comment on each such Commercialization Plan and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Commercialization Plan. Thereafter, from time to time, [****] Zai will propose updates to the Commercialization Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including those in response to changes in the marketplace, relative commercial success of the applicable Licensed Product, and other relevant factors that may influence such plan and the Commercialization activities set forth therein. Zai will submit each proposed updated Commercialization Plan for a Licensed Product to the JPT for review and discussion and will consider [****] and incorporate [****] any comments thereon provided by the JPT before finalizing any such update. Zai submit each initial Commercialization Plan and each such proposed updated Commercialization Plan to the JSC. The JSC will review, discuss, and determine whether to approve each initial Commercialization Plan for each Licensed Product and each update thereto. Once approved by the JSC, each update to a Commercialization Plan for a Licensed Product will become effective and supersede the then-current Commercialization Plan for such Licensed Product. Each Commercialization Plan for a Licensed Product (including each update thereto) must be consistent with Blueprints global brand strategy and global key messaging, and Global Brand Elements for such Licensed Product (each, a Global Brand Strategy), if and as provided to Zai by Blueprint from time to time during the Term; provided, however, that if the JSC agrees upon brand strategy for a Licensed Product that is specific to the Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product (including any product positioning or messaging for the Territory or any region therein), then Zai will have the right to implement such Territory-specific brand strategy within the Territory and to incorporate such inconsistent strategies in the Commercialization Plan for such Licensed Product. |
9.3 | Conduct of Commercialization Activities. Zai will conduct all Commercialization of Licensed Products in the Territory in accordance with the applicable Commercialization Plan. Zai will not conduct any Commercialization activities with respect to Licensed Products except for those activities set forth in an applicable Commercialization Plan. |
9.4 | Commercialization Reports. For each Calendar Year following the first Regulatory Approval for a Licensed Product in the Territory, [****] Zai will provide to Blueprint a report [****] summarizing the Commercialization activities performed by or on behalf of Zai and its Affiliates and Sublicensees in the Territory for each Licensed Product in each region in the Territory since the prior report provided by Zai. Each such report will contain sufficient detail to enable Blueprint to assess Zais compliance with its Commercialization diligence obligations set forth in Section 9.1 (Commercialization Diligence Obligations). Such reports will be Confidential Information of Zai and subject to the terms of Article 11 (Confidentiality; Publication). Zai will provide updates to any such report at each meeting of the JSC, JPT, and any Working Group established by the JSC to oversee Commercialization activities under this Agreement. |
9.5 | Coordination of Commercialization Activities. The Parties recognize that each Party may benefit from the coordination of certain Commercialization activities for the Licensed Products inside and outside of the Territory (other than pricing for the Licensed Products inside and outside of the Territory, the responsibilities for which are set forth in Section 9.6 (Pricing; Reimbursement Approvals)). Accordingly, the Parties will coordinate such activities through the JPT where appropriate, which coordination may include communications regarding product positioning. |
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9.6 | Pricing; Reimbursement Approvals. Notwithstanding any provision to the contrary set forth in this Agreement, each Party will have the right to determine the price of the Licensed Products sold in its territory and neither Party will have the right to direct, control, or approve the pricing of the Licensed Products in the other Partys territory. Zai will keep Blueprint timely informed on (a) any [****] changes to the [****] pricing strategies with respect to any Licensed Product in the Territory, and (b) the status of any application for Reimbursement Approval for a Licensed Product in the Territory, including any discussion with any Regulatory Authority with respect thereto. |
9.7 | Diversion. Each Party agrees that it will not, and will ensure that its Affiliates and licensees and subcontractors (or Sublicensees and Subcontractors, as applicable) will not, either directly or indirectly, promote, market, distribute, import, sell, or have sold any Licensed Products to any Third Party or to any address or Internet Protocol address or the like outside of such Partys respective territory, including via the Internet or mail order. Neither Party will engage, and each Party will not permit its Affiliates or Sublicensees to engage, in any advertising or promotional activities relating to any Licensed Products for use directed primarily to customers or other buyers or users of the Licensed Products located in any country or jurisdiction outside of such Partys respective territory, or solicit orders from any prospective purchaser located in any country or jurisdiction outside of such Partys respective territory. If either Party or its respective Affiliates or licensees (or Sublicensees, as applicable) receives any order for any Licensed Products from a prospective purchaser located in a country or jurisdiction outside of such Partys respective territory, then such Party will immediately refer that order to the other Party and will not accept any such orders. Neither Party will, and neither Party will permit its Affiliates, licensees (or Sublicensees, as applicable), or subcontractors (or Subcontractors, as applicable) to, deliver or tender (or cause to be delivered or tendered) any Licensed Products to Third Parties for use outside of such Partys respective territory, except in accordance with a Global Development Plan or Territory-Specific Development Plan, or except in connection with a Manufacturing Technology Transfer pursuant to Section 4.2 (Manufacturing Technology Transfer) and Article 7 (Manufacturing). For purposes of this Section 9.7 (Diversion), (a) Zais territory will be the Territory and (b) Blueprints territory will be worldwide except for the Territory. |
Article 10
PAYMENTS
10.1 | Upfront Payment. Within [****] after the Effective Date, Zai will pay to Blueprint by wire transfer of immediately available funds a non-refundable, non-creditable upfront payment of $25,000,000 in U.S. Dollars (the Upfront Payment). |
10.2 | Milestone Payments. |
10.2.1 | Development Milestone Events and Payments. No later than [****] after the earliest achievement of each development milestone event set forth below [****], Zai will pay to Blueprint the corresponding non-refundable, non-creditable development milestone payment set forth below (the development milestone events set forth in Table 10.2.1 the Development Milestone Events and the development milestone payments set forth in Table 10.2.1 the Development Milestone Payments). |
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Table 10.2.1 LICENSED PRODUCT DEVELOPMENT MILESTONES | ||||
Development Milestone Events For
Licensed |
Development Milestone | |||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] |
[****]
[****]
10.2.2 | Sales Milestone Events and Payments. On a Licensed Product-by-Licensed Product basis, no later than [****] after the end of the first Calendar Quarter in which each sales milestone event set forth below for such Licensed Product is achieved, Zai will pay to Blueprint with respect to each Licensed Product the corresponding non-refundable, non-creditable sales milestone payment set forth below in Table 10.2.2 (the sales milestone events set forth in Table 10.2.2, the Sales Milestone Events and the sales milestone payments set forth in Table 10.2.2, the Sales Milestone Payments). If in a given Calendar Year more than one of the Sales Milestone Events set forth in Table 10.2.2 below is achieved with respect to a particular Licensed Product, then Zai will pay to Blueprint a separate Sales Milestone Payment with respect to each such Sales Milestone Payment that is achieved for the first time in such Calendar Year. For purposes of this Section 10.2.2 (Sales Milestone Events and Payments), (a) Licensed Products containing [****] and (b) Combination Products containing [****]. |
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Table 10.2.2 SALES MILESTONES FOR LICENSED PRODUCTS | ||||
Sales Milestone Event |
Sales Milestone | |||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] | ||
[****] |
[****] |
[****] |
[****]
10.2.3 | Milestone Conditions. |
(a) | Notification of Milestone Events. Zai will promptly notify Blueprint in writing, but in no event later than (i) [****] after the achievement of each Development Milestone Event and (ii) [****]after the end of the Calendar Quarter in which each Sales Milestone Event is achieved (together with the Development Milestone Events, the Milestone Events). However, in no event will a failure by Zai to deliver such notice of achievement of a Milestone Event relieve Zai of its obligation to pay Blueprint the corresponding Development Milestone Payment or Sales Milestone Payment (collectively, the Milestone Payments). |
(b) | Skipped Milestone Events. If Zai achieves any of the Development Milestone Events for a particular Licensed Product [****] but without the prior achievement of any corresponding earlier listed Development Milestone Events for such Licensed Product [****], then Zai will pay to Blueprint the applicable Milestone Payment to be made with respect to such earlier Development Milestone Events for such Licensed Product [****] at the same time as Zai pays the applicable Development Milestone Payment due upon achievement of such Development Milestone Event. For example, [****]. |
(c) | Maximum Milestone Payment Example. For example: [****]. |
10.3 | Royalty Payments to Blueprint. |
10.3.1 | Royalty Rates. Subject to the remainder of this Section 10.3 (Royalty Payments to Blueprint), Zai will make non-refundable royalty payments to Blueprint, on a Licensed Product-by-Licensed Product basis for Licensed Products sold in the Territory during the applicable Royalty Term, calculated by multiplying the applicable royalty rate set forth below in Table 10.3.1 by [****]. The royalty payments due with respect to Net Sales of each Licensed Product pursuant to this Section 10.3 (Royalty Payments to Blueprint), collectively the Royalty Payments. For purposes of this Section 10.3 (Royalty Payments to Blueprint), (a) Licensed Products [****] and (b) Combination Products [****]. |
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Table 10.3.1 LICENSED PRODUCT ROYALTY PAYMENTS | ||
Portion of Aggregate Calendar Year Net Sales of
the same Licensed Product in the Territory |
Royalty Rate | |
[****] | [****] | |
[****] | [****] | |
[****] | [****] | |
[****] | [****] |
[****]
10.3.2 | Royalty Term. Zai will pay to Blueprint the Royalty Payments on a Licensed Product-by-Licensed Product and region-by-region basis beginning on the date of the First Commercial Sale of such Licensed Product in such country or region and lasting until the later of: (a) [****] (b) [****] and (c) [****] (Royalty Term). |
10.3.3 | Royalty Reductions. |
(a) | Expiration of Valid Claims. Subject to Section 10.3.3(c) (Cumulative Reductions Floor), on a Licensed Product-by-Licensed Product and region-by-region basis, if there is no Valid Claim of a Royalty Patent Right that Covers the Licensed Product [****] in such region, then, commencing [****] after the date on which this Section 10.3.3(a) (Expiration of Valid Claims) applies and for all [****] thereafter during which this Section 10.3.3(a) (Expiration of Valid Claims) applies, the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such region under Section 10.3.1 (Royalty Payments to Blueprint) will be [****]; provided that if such Licensed Product [****] subsequently becomes Covered by a Valid Claim within the Royalty Patent Rights in such region prior to [****], then the applicable royalty rate that would otherwise be owed on such Net Sales of such Licensed Product in such region will no longer be subject to the aforementioned reduction beginning at [****]. |
(b) | Offset For Third Party Licensing Payments. Subject to Section 2.6 (Third Party In-Licenses) and Section 10.3.3(c) (Cumulative Reductions Floor), Zai will be entitled to, on a country-by-country basis, credit against the royalties due to Blueprint upon Net Sales of a Licensed Product in such country an amount equal to [****]of the total royalties paid by Zai to Third Parties with respect to license rights to Patent Rights, or Patent Rights together with Know-How, controlled by Third Parties that are necessary to avoid infringement of such Third Party rights in the Territory (i) [****] or (ii) [****]. |
(c) | Cumulative Reductions Floor. In no event will the aggregate amount of Royalty Payments due to Blueprint for a Licensed Product in a region in the Territory in any given [****] during the Royalty Term for such Licensed Product in such region be reduced to less than [****] of the amount that otherwise would have been due and payable to Blueprint in such [****] for such Licensed Product in such region but for the reductions set forth in Section 10.3.3(a) (Expiration of Valid Claims) and Section 10.3.3(b) (Offset For Third Party Licensing Payments). |
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10.3.4 | Royalty Reports and Payments. Commencing with the [****] during which the First Commercial Sale of a Licensed Product is made anywhere in the Territory, [****] Zai will provide Blueprint with [****] the amount of royalties payable by Zai for the applicable [****], on a Licensed Product-by-Licensed Product and region-by-region basis (each, a Royalty Estimate). [****] Zai will provide Blueprint with a detailed report for the applicable [****], on a Licensed Product-by-Licensed Product and region-by-region basis (each, a Royalty Report) containing: (a) the amount of gross sales and Net Sales of each Licensed Product sold by Zai and its Affiliates and Sublicensees in each region and all deductions used to determine such Net Sales of each such Licensed Products for such [****], (b) a calculation of the Royalty Payment due on such Net Sales of each Licensed Product in each region, including any royalty reduction made in accordance with Section 10.3.3(a) (Expiration of Valid Claims) and Section 10.3.3(b) (Offset For Third Party Licensing Payments), (c) the exchange rate used for converting any Net Sales recorded in a currency other than Dollars, (d) any withholding taxes required to be made from such Royalty Payments, and (e) the quantity and description of each Licensed Product sold by Zai or its Affiliate or Sublicensee in each region in the Territory during such [****] comprising such Net Sales, including detailed sales reports for each Licensed Product for [****] in each region in the Territory. Concurrent with the delivery of the applicable Royalty Report, [****], Zai will pay the amount of the Royalty Payments set forth in the applicable Royalty Report to Blueprint in Dollars. If requested by Blueprint, the Parties will seek to resolve any questions or issues related to a Royalty Report within [****] following receipt by Blueprint of each Royalty Report. |
10.4 | Payments to Third Parties Under Existing Agreements. Each Party will be solely responsible for any payments due to Third Parties under any agreement entered into by such Party prior to the Effective Date. |
10.5 | Other Amounts Payable. With respect to any amounts owed under this Agreement by one Party to the other for which no other invoicing and payment procedure is specified hereunder, within [****] after the end of each [****], each Party will provide an invoice, together with reasonable supporting documentation, to the other Party for such amounts owed in respect of such [****]. The owing Party will pay any undisputed amounts within [****] of receipt after the invoice, and any disputed amounts owed by a Party will be paid within [****] after resolution of the dispute. As used throughout this Agreement, a disputed amount owed by one Party to the other Party will be considered undisputed hereunder following a final, unappealable determination in accordance with Article 16 (Dispute Resolution) that such amount is owed. |
10.6 | No Refunds. Except as expressly provided herein or in the case of an overpayment of Royalty Payments [****], all payments under this Agreement will be irrevocable, non-refundable, and non-creditable. |
10.7 | Accounting Standards. If a Party changes its general accounting principles from the then-current standard (e.g., from GAAP to IFRS) at any time during the Term, then at least [****] prior to adopting such change in principles, such Party will provide written notice to the other Party of such change. |
10.8 | Currency; Exchange Rate. All payments to be made by Zai to Blueprint or Blueprint to Zai under this Agreement will be made in Dollars by electronic funds transfer in immediately available funds to a bank account designated in writing by Blueprint or Zai, as applicable. Conversion of Net Sales recorded in local currencies will be converted to Dollars at the exchange rate set forth in Wall Street Journal or any successor thereto for [****]. |
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10.9 | Blocked Payments. If by reason of Applicable Law in any country or region, it becomes impossible or illegal for a Party to transfer, or have transferred on its behalf, payments owed the other Party hereunder, then such Party will promptly notify the other Party of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country or region to the credit of the other Party in a recognized banking institution designated by the other Party or, if none is designated by the other Party within a period of [****], in a recognized banking institution selected by the transferring Party, as the case may be, and identified in a written notice given to the other Party. |
10.10 | Late Payments. Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement will bear interest at a rate equal to the lesser of: (a) [****] as published by The Wall Street Journal or any successor thereto on the [****] in which such payments are overdue; or (b) the maximum rate permitted by Applicable Law; in each case, calculated on the number of days such payment is delinquent, compounded monthly. |
10.11 | Financial Records and Audits. Each Party will maintain complete and accurate records in sufficient detail to permit the other Party to confirm the accuracy of the amount of royalty payments and other amounts payable under this Agreement. Upon reasonable prior notice, such records will be open during regular business hours for a period of [****] from the creation of individual records for examination by an independent certified public accountant selected by the examining Party and reasonably acceptable to the other Party for the sole purpose of verifying for the examining Party the accuracy of the financial reports furnished by the other Party (the Examined Party) pursuant to this Agreement or of any payments made, or required to be made, by such Examined Party pursuant to this Agreement; provided that such independent accounting firm is subject to written obligations of confidentiality and non-use applicable to each Partys Confidential Information that are at least as stringent as those set forth in Article 11 (Confidentiality; Publication). Such audit will not be (a) performed more frequently than [****] during the Term or [****] after the expiration or termination of this Agreement, (b) conducted for any Calendar Year [****] after the end of such year, or (c) repeated for any Calendar Year or with respect to the same set of records (unless a material discrepancy with respect to such records is discovered during a prior audit). Such auditor will not disclose the Examined Partys Confidential Information to the examining Party or to any Third Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by the Examined Party or the amount of payments by the Examined Party under this Agreement. The Examined Party will pay any amounts shown to be owed to the examining Party but unpaid within [****] after the accountants report, plus interest (as set forth in Section 10.10 (Late Payments)) from the original due date. The examining Party will bear the full cost of such audit unless such audit reveals an underpayment by the Examined Party of [****], in which case the Examined Party will reimburse the examining Party for the reasonable audit fees for such examination. |
10.12 | Taxes. |
10.12.1 | Taxes on Income. Except as set forth in this Section 10.12 (Taxes) or Section 10.13 (VAT Credits), each Party will be solely responsible for the payment of any and all Taxes levied on account of all payments it receives under this Agreement. |
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10.12.2 | Tax Cooperation. The Parties agree to cooperate with one another in accordance with Applicable Law and use reasonable efforts to minimize Tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by each Party to the other Party under this Agreement. To the extent either Party (the Paying Party) is required to deduct and withhold Taxes on any payment to the other Party (the Recipient), the Paying Party will (a) pay the amount of such Taxes to the proper Governmental Authority in a timely manner, and (b) promptly transmit to the Recipient an official tax certificate or other evidence of such payment sufficient to enable the Recipient to claim such payment of Taxes on the Recipients applicable tax returns. The Paying Party will provide the Recipient with advance notice prior to withholding any Taxes from payments payable to the Recipient and will, to the extent practicable, provide the Recipient with a commercially reasonable period of time to claim an exemption or reduction in otherwise applicable Taxes. The Recipient will provide the Paying Party any tax forms that may be reasonably necessary in order for the Paying Party to not withhold Tax or to withhold Tax at a reduced rate under an applicable bilateral income tax treaty, to the extent the Paying Party is legally able to do so. The Recipient will use reasonable efforts to provide any such tax forms to the Paying Party in advance of the due date. Each Party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Law, of withholding Taxes or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Paying Party if the Paying Party is the Party bearing such withholding Tax under this Section 10.12 (Taxes). In addition, the Parties will cooperate in accordance with Applicable Law to minimize indirect Taxes (such as VAT, sales tax, consumption tax, and other similar Taxes) in connection with this Agreement. In the event of any inconsistency between this Section 10.12 (Taxes) and Section 10.13 (VAT Credits), Section 10.13 (VAT Credits) will take precedence. |
10.12.3 | Changes in Domicile. Notwithstanding anything to the contrary in this Agreement, if the Paying Party assigns, transfers or otherwise disposes of some or all of its rights and obligations to any Person and if, as a result of such action, the withholding or deduction of Tax required by Applicable Law with respect to payments under this Agreement is increased, then any amount payable to the Recipient under this Agreement will be increased to take into account such withheld Taxes as may be necessary so that, after making all required withholdings (including withholdings on the withheld amounts), the Recipient receives an amount equal to the sum it would have received had no such withholding been made. |
10.12.4 | Returns. All transfer, documentary, sales, use, stamp, registration, and other such Taxes, and any conveyance fees, recording charges, and other fees and charges (including any penalties and interest) incurred in connection with consummation of the transactions contemplated hereby, if any, will be borne and paid by the Paying Party. The Paying Party will prepare and timely file all tax returns required to be filed in respect of any such Taxes. The Parties will reasonably cooperate in accordance with Applicable Law to minimize transfer Taxes in connection with this Agreement. |
10.13 | VAT Credits. All payments due to Blueprint from Zai pursuant to this Agreement will be paid without any deduction for any VAT that Zai may be required to pay to any tax authorities in the Territory. Blueprint will use Commercially Reasonable Efforts to assist Zai to minimize and obtain all available exemptions from such VAT or other taxes, but if applicable, Zai will pay any such VAT to the proper taxing authorities upon receipt of a valid VAT invoice (where such invoice is required under local VAT laws). If Zai is required to pay or Blueprint is required to report, any such VAT, then [****]. Zai will promptly provide to Blueprint applicable receipts evidencing payment of such VAT and other documentation reasonably requested by Blueprint. |
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Article 11
CONFIDENTIALITY; PUBLICATION
11.1 | Duty of Confidence. Subject to the other provisions of this Article 11 (Confidentiality; Publication): |
11.1.1 | except to the extent expressly authorized by this Agreement, all Confidential Information of a Party (the Disclosing Party) will be maintained in confidence and otherwise safeguarded, and not published or otherwise disclosed, by the other Party (the Receiving Party) and its Affiliates for the Term and for [****] thereafter; |
11.1.2 | the Receiving Party will treat all Confidential Information provided by the Disclosing Party with the same degree of care as the Receiving Party uses for its own similar information, but in no event less than a reasonable degree of care; |
11.1.3 | the Receiving Party may only use any Confidential Information of the Disclosing Party for the purposes of performing its obligations or exercising its rights under this Agreement; |
11.1.4 | a Receiving Party may disclose Confidential Information of the Disclosing Party to: (a) such Receiving Partys Affiliates, licensees and Sublicensees; and (b) employees, directors, officers, agents, contractors, consultants, attorneys, accountants, banks, investors, and advisors of the Receiving Party and its Affiliates, licensees, and Sublicensees, in each case ((a) and (b)), to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that such Persons are bound by legally enforceable obligations of confidentiality and non-use with respect to the Disclosing Partys Confidential Information no less stringent than the confidentiality and non-use obligations set forth in this Agreement. Each Party will remain responsible for any failure by its Affiliates, licensees, and Sublicensees, and its and its Affiliates, licensees, and Sublicensees respective employees, directors, officers, agents, consultants, attorneys, accountants, banks, investors, advisors, and contractors, in each case, to treat such Confidential Information as required under this Section 11.1 (Duty of Confidence) (as if such Affiliates, licensees, Sublicensees, employees, directors, officers agents, consultants, advisors, attorneys, accountants, banks, investors, and contractors were Parties directly bound to the requirements of this Section 11.1 (Duty of Confidence)); and |
11.1.5 | each Party will promptly notify the other Party of any misuse or unauthorized disclosure of the other Partys Confidential Information. |
11.2 | Confidential Information. The Blueprint Know-How and Blueprint Manufacturing Know-How will be the Confidential Information of Blueprint notwithstanding the fact that certain of such information may be developed or invented and disclosed to Blueprint by Zai. The Joint Collaboration Know-How and the terms of this Agreement will be the Confidential Information of each Party. The Zai Know-How will be the Confidential Information of Zai. Except as provided in Section 11.3 (Authorized Disclosures) and Section 11.7 (Publicity; Use of Names), neither Party nor its Affiliates may disclose the existence or the terms of this Agreement. |
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11.3 | Authorized Disclosures. |
11.3.1 | Permitted Circumstances. Notwithstanding the obligations set forth in Section 11.1 (Duty of Confidence) and Section 11.6 (Publication and Listing of Clinical Trials), a Party may disclose the other Partys Confidential Information (including this Agreement and the terms herein) to the extent such disclosure is reasonably necessary in the following situations: |
(a) | (i) the Patent Prosecution, enforcement, and defense of Blueprint Patent Rights, Joint Collaboration Patent Rights, or Zai Collaboration Patent Rights, in each case, as contemplated by this Agreement; or (ii) regulatory filings and other filings with Governmental Authorities (including Regulatory Authorities), as necessary or reasonably useful for the Exploitation of a Licensed Product; |
(b) | disclosure of this Agreement, its terms, and the status and results of Exploitation of one or more Licensed Products to actual or bona fide [****] solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, (sub)license, debt transaction, or collaboration; provided that, in each such case, on the condition that such Persons are bound by obligations of confidentiality and non-use at least as stringent as those set forth Article 11 (Confidentiality; Publication) or otherwise customary for such type and scope of disclosure and that any such disclosure is limited to the maximum extent practicable for the particular context in which it is being disclosed; |
(c) | such disclosure is required to comply with Applicable Law (whether generally or in pursuit of an application for listing of securities) including the United States Securities and Exchange Commission, the Stock Exchange of Hong Kong Limited, or equivalent foreign agency or regulatory body, or otherwise required by judicial or administrative process, provided that in each such event, as promptly as reasonably practicable and to the extent not prohibited by Applicable Law or judicial or administrative process, such Party will notify the other Party of such required disclosure and provide a draft of the disclosure to the other Party reasonably in advance of such filing or disclosure for the other Partys review and comment. The non-disclosing Party will provide any comments as soon as practicable, and the disclosing Party will consider [****] comments provided by the non-disclosing Party; provided that [****]. Confidential Information that is disclosed in order to comply with Applicable Law or by judicial or administrative process pursuant to this Section 11.3.1(c), in each case, will remain otherwise subject to the confidentiality and non-use provisions of this Article 11 (Confidentiality; Publication) with respect to the Party disclosing such Confidential Information, and such Party will take all steps reasonably necessary, including seeking of confidential treatment or a protective order for a period of at least [****] (to the extent permitted by Applicable Law or Governmental Authority), to ensure the continued confidential treatment of such Confidential Information, and each Party will be responsible for its own legal and other external costs in connection with any such filing or disclosure pursuant to this Section 11.3.1(c) (Permitted Circumstances); |
(d) | to prosecute or defend litigation [****]; |
(e) | to present, disclose, and discuss general information about the existence of the Agreement and the general progress of the Licensed Products at investor press conferences or similar events; or |
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(f) | disclosure pursuant to Section 11.6 (Publication and Listing of Clinical Trials) and Section 11.7 (Publicity; Use of Name). |
11.3.2 | Confidential Treatment. Notwithstanding anything to the contrary set forth in this Agreement, if a Party is required or permitted to make a disclosure of the other Partys Confidential Information pursuant to Section 11.3.1 (Permitted Circumstances), then it will, to the extent not prohibited by Applicable Law or judicial or administrative process, except where impracticable, give reasonable advance notice to the other Party of such proposed disclosure and use reasonable efforts to secure confidential treatment of such information and will only disclose that portion of Confidential Information that is legally required to be disclosed as advised by its legal counsel. In any event, each Party agrees to take all reasonable action to avoid disclosure of Confidential Information of the other Party hereunder. |
11.4 | Tax Treatment. Nothing in Section 11.1 (Duty of Confidence) or 11.3 (Authorized Disclosures) will limit either Party in any way from disclosing to any Third Party such Partys U.S. or foreign income Tax treatment and the U.S. or foreign income Tax structure of the transactions relating to such Party that are based on or derived from this Agreement, or materials of any kind (including opinions or other Tax analyses) relating to such Tax treatment or Tax structure, except to the extent that nondisclosure of such matters is reasonably necessary in order to comply with applicable securities laws. |
11.5 | Publications. |
11.5.1 | Zai will not publicly present or publish any Clinical Trial data, non-clinical or preclinical data, clinical case study or review article, or any associated results or conclusions generated by or on behalf of Zai with respect to Licensed Products pursuant to this Agreement (each such proposed abstract, presentation or publication, a Zai Publication), except [****] with respect to the applicable Licensed Product as provided to Zai [****] during the Term upon Zais request therefor, and subject to the additional limitations set forth in this Section 11.5 (Publications) and Section 11.6 (Publication and Listing of Clinical Trials). Blueprint will comply with this Section 11.5 (Publications) with respect to any presentation or publication of solely containing Clinical Trial data, non-clinical or preclinical data, clinical case study or review article, or any associated results or conclusions that were generated by or on behalf of Zai with respect to Licensed Products pursuant to this Agreement (each such proposed abstract, presentation or publication, a Blueprint Publication and together with a Zai Publication, a Publication). |
11.5.2 | If Zai desires to publicly present or publish a Zai Publication or Blueprint desires to publicly present or publish a Blueprint Publication, then the publishing Party will provide the other Party (including the Alliance Manager and all of the other Partys members of the JSC) with a copy of such proposed Publication at least [****] prior to the earlier of its presentation or intended submission for publication (such applicable period, the Review Period). The publishing Party agrees that it will not submit or present any Publication until (a) [****]or (b) [****] in which case the publishing Party may proceed and the Publication will be considered approved in its entirety. If the publishing Party receives written comments from the other Party on any Publication during the applicable Review Period, then it will consider the other Partys comments [****] and incorporate such comments [****], but will retain the sole authority to publish the Publication. |
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11.5.3 | Notwithstanding any provision to contrary set forth in this Agreement, each Party will (i) delete any Confidential Information of the other Party that the other Party identifies for deletion in the other Partys written comments, (ii) at the request of Blueprint, delete any Clinical Trial data, results, conclusions, or other related information for a Licensed Product the publication of which Blueprint determines, [****] would conflict with Blueprints global publication strategy with respect to the applicable Licensed Product, except where required by Applicable Law to publicly disclose such information, (iii) at the request of the other Party, delete the structure or generic or internal name of the Licensed Product if such structure or name has not yet been publicly disclosed, and (iv) delay such Publication for a period of up to an additional [****] after the end of the applicable Review Period to enable the other Party, if applicable, to draft and file one or more patent applications with respect to any subject matter to be made public in such Publication. The publishing Party will provide the other Party a copy of the Publication at the time of the submission or presentation thereof. The publishing Party agrees to acknowledge the contributions of the other Party and the employees of the other Party, in each case, in all Publications as scientifically appropriate. Without limiting the foregoing, Blueprint agrees to acknowledge the contributions of Zai and the employees of Zai, in each case, in all presentations and publications as scientifically appropriate to the extent related to any Global Clinical Trials in which Zai assists in the enrollment of patients from the PRC. Each Party will require its Affiliates and licensees and Sublicensees, as applicable, to comply with the obligations of this Section 11.5 (Publications) as if they were such Party, and such Party will be liable for any non-compliance of such Persons. |
11.6 | Publication and Listing of Clinical Trials. With respect to the listing of Clinical Trials or the publication of Clinical Trial results for the Licensed Products and to the extent applicable to a Partys activities conducted under this Agreement, each Party will comply with (a) the Pharmaceutical Research and Manufacturers of America (PhRMA) Guidelines on the listing of Clinical Trials and the Publication of Clinical Trial results, and (b) any Applicable Law or applicable court order, stipulations, consent agreements, and settlements entered into by such Party. The Parties agree that any such listings or publications made pursuant to this Section 11.6 (Publication and Listing of Clinical Trials) will be considered a Publication for purposes of this Agreement and will be subject to Section 11.5 (Publications). |
11.7 | Publicity; Use of Names. |
11.7.1 | Press Release. The Parties have agreed on a joint press release announcing this Agreement, set forth on Schedule 11.7.1 (Press Release), to be issued by the Parties on such date and time as may be agreed by the Parties. Other than the press release set forth on Schedule 11.7.1 (Press Release) and the public disclosures permitted by this Section 11.7 (Publicity; Use of Names), and Section 11.3 (Authorized Disclosures), the Parties agree that [****]. However, the Parties agree that after (a) a disclosure pursuant to Section 11.7 (Publicity; Use of Names) or Section 11.3 (Authorized Disclosures) or (b) the issuance of a press release (including the initial press release) or other public announcement pursuant to this Section 11.7.1 (Press Release) that has been reviewed and approved by the other Party, the disclosing Party may make subsequent public disclosures reiterating such information without having to obtain the other Partys prior consent and approval so long as the information in such press release or other public announcement remains true, correct, and the most current information with respect to the subject matters set forth therein. Similarly, after a Publication has been made available to the public, each Party may post such Publication or a link to it on its corporate web site (or any website managed by such Party in connection with a Clinical Trial for a Licensed Product, as appropriate) without the prior written consent of the other Party, so long as the information in such Publication remains true, correct, and the most current information with respect to the subject matters set forth therein. |
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11.7.2 | Authorized Disclosures. Notwithstanding any provision to the contrary set forth in this Agreement, each Party has the right to publicly disclose (in written, oral, or other form): (a) the achievement of Milestone Events under this Agreement (including the amount, payment, and timing of any such Milestone Event); (b) the commencement, completion, material data, or key results of any Territory-Specific Clinical Trials for the Licensed Products; (c) any information relating to any Global Clinical Trial, including the commencement, completion, material data, or key results of any such Global Clinical Trial; and (d) the achievement of Regulatory Approval for any Licensed Product in the Territory; provided, that, in each case of (a) (d), any such public disclosure will (i) to the extent feasible, be provided to the other Party for review and comment [****] and (ii) in any event, be provided to the other Party for review and comment no later than [****] prior to public disclosure (unless a shorter timeframe is required under Applicable Law). |
11.7.3 | Use of Names. Each Party will have the right to use the other Partys name and logo in presentations, its website, collateral materials, and corporate overviews to describe the collaboration relationship, as well as in taglines of press releases issued pursuant to this Section 11.7 (Publicity; Use of Names); provided that each Party will use the other Partys corporate name in such manner that the distinctiveness, reputation, and validity of any trademarks and corporate or trade names of such other Party will not be impaired, and consistent with best practices used by such other Party for its other collaborators. Except as permitted under this Section 11.7 (Publicity; Use of Names) or with the prior express written permission of the other Party, neither Party will use the name, trademark, trade name, or logo of the other Party or its Affiliates or their respective employees in any publicity, promotion, news release, or disclosure relating to this Agreement or its subject matter except as may be required by Applicable Law. Each Party will use the other Partys corporate name in all publicity relating to this Agreement, including the initial press release and all subsequent press releases issued pursuant to the terms of this Agreement. Zai will, to the extent consistent with Applicable Law, include explanatory text such as (a) Discovered by Blueprint Medicines Corporation in all publicity, promotion, news releases, or similar disclosures relating to the Licensed Products that are not Blueprint/Zai Combinations, and (b) Discovered in Collaboration by Blueprint Medicines Corporation and Zai Pharmaceuticals in all publicity, promotion, news releases, or similar disclosures relating to any Blueprint/Zai Combinations, in each case ((a) and (b)), or such other similar text provided by Blueprint and reasonably acceptable to Zai. |
11.8 | Attorney-Client Privilege. Neither Party is waiving, nor will be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges or the like as a result of disclosing information pursuant to this Agreement, or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the Receiving Party, regardless of whether the Disclosing Party has asserted such privileges and protections. The Parties: (a) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections; (b) are or may become joint defendants in proceedings to which the information covered by such protections and privileges relates; (c) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the Disclosing Partys Confidential Information covered by such protections and privileges relates; and (d) intend that after the Effective Date both the Receiving Party and the Disclosing Party will have the right to assert such protections and privileges. Notwithstanding the foregoing, nothing in this Section 11.8 (Attorney-Client Privilege) will apply with respect to a Dispute between the Parties (including their respective Affiliates). |
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Article 12
REPRESENTATIONS, WARRANTIES, AND COVENANTS
12.1 | Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date as follows: |
12.1.1 | It is a corporation or limited company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and it has the full right, power and authority to enter into this Agreement and to perform its obligations hereunder. |
12.1.2 | It has not been Debarred/Excluded and no proceeding that could result it in being Debarred/Excluded is pending, and neither it nor any of its Affiliates has used, in any capacity in the performance of obligations relating to the Licensed Products, any employee, Subcontractor, consultant, agent, representative, or other Person who has been Debarred/Excluded. |
12.1.3 | All consents, approvals and authorizations from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained. |
12.1.4 | This Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it. |
12.1.5 | To its Knowledge, neither it nor any of its Affiliates, or its or their directors, officers, employees, distributors, agents, representatives, sales intermediaries, or other Third Parties acting on its behalf or any of its Affiliates: |
(a) | has taken any action in violation of any local and other anti-corruption laws (including the provisions of the United States Foreign Corrupt Practices Act, collectively Anti-Corruption Laws); or |
(b) | has corruptly offered, paid, given, promised to pay or give, or authorized the payment or gift of anything of value, directly or indirectly, to any Public Official, for the purposes of: |
(i) | influencing any act or decision of any Public Official in his or her official capacity; |
(ii) | inducing such Public Official to do or omit to do any act in violation of his or her lawful duty; |
(iii) | securing any improper advantage; or |
(iv) | inducing such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary, laboratory or medical facilities) in obtaining or retaining any business whatsoever. |
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12.2 | Representations and Warranties of Blueprint. Blueprint represents and warrants to Zai as of the Effective Date with respect to itself and its Affiliates as follows: |
12.2.1 | It has the right under the Blueprint Technology to grant to Zai the licenses set forth in this Agreement, and it has not granted any license or other right under the Blueprint Technology that is inconsistent with the licenses purported to be granted to Zai hereunder. |
12.2.2 | [****] |
12.2.3 | There is no pending or, to Blueprints Knowledge, threatened (in writing) litigation, nor has Blueprint received any written notice from any Third Party, asserting or alleging that the Exploitation of the Blueprint Compounds or the Licensed Products prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party. |
12.2.4 | There are no legal claims, judgments, or settlements against or owed by Blueprint or any of its Affiliates, or pending or, to Blueprints Knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, or Anti-Corruption Law violations. |
12.2.5 | To Blueprints Knowledge, the Exploitation of the Blueprint Compounds as contemplated under this Agreement does not infringe any issued Patent Right of any Third Party. |
12.2.6 | [****] |
12.2.7 | Each employee of Blueprint and its Affiliates involved in the programs related to the Blueprint Compounds is bound by an agreement or policy requiring such employee to assign Inventions invented by such employee to Blueprint or such Affiliate. |
12.2.8 | Blueprint does not have agreements with any Third Parties under which Blueprint Controls any Blueprint Patent Rights or Blueprint Know-How as of the Effective Date. |
12.2.9 | All information provided by Blueprint to Zai for due diligence purposes in relation to this Agreement, to Blueprints Knowledge, is complete and accurate in all material respects. |
12.3 | Representations and Warranties of Zai. Zai represents and warrants to Blueprint as follows (a) [****], and (b) [****]: |
12.3.1 | It has the right under the Zai Technology to grant to Blueprint the licenses set forth in this Agreement, and it has not granted any license or other right under the Zai Technology that is inconsistent with the licenses purported to be granted to Blueprint hereunder. |
12.3.2 | There is no Zai Technology in existence as of the Effective Date. |
12.3.3 | There is no pending or, to Zais Knowledge, threatened (in writing) litigation, nor has Zai received any written notice from any Third Party, asserting or alleging that the Exploitation of any Zai Product as part of any Blueprint/Zai Combination in the Territory as contemplated under this Agreement will infringe or misappropriate the intellectual property rights of such Third Party. |
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12.3.4 | There are no legal claims, judgments, or settlements against or owed by Zai or any of its Affiliates, or pending or, to Zais Knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, or Anti-Corruption Law violations. |
12.3.5 | Zai has sufficient financial wherewithal to perform all of its obligations set forth under this Agreement as they come due. |
12.3.6 | Each employee of Zai and its Affiliates is bound by an agreement or policy requiring such employee to assign Inventions invented by such employee to Zai or such Affiliate. |
12.3.7 | Zai has, or can readily obtain, sufficient technical, clinical, and regulatory expertise to perform all of its obligations pursuant to this Agreement, including its obligations relating to Development, Manufacturing, Medical Affairs, Commercialization, and obtaining Regulatory Approvals, in each case, of the Blueprint Compounds and Licensed Products as contemplated under this Agreement. |
12.3.8 | None of the officers, directors, or employees of Zai or of any of its Affiliates or agents acting on behalf of Zai or any of its Affiliates, in each case, that are employed or reside outside the United States, is a Public Official. |
12.3.9 | Zai or its Affiliate that will serve as Blueprints regulatory agent (as applicable) in the PRC as contemplated by this Agreement has met all qualification requirements required under Applicable Law to be Blueprints regulatory agent in the PRC as contemplated by this Agreement. |
12.4 | Covenants of Zai. Zai covenants to Blueprint that: |
12.4.1 | In the course of performing its obligations or exercising its rights under this Agreement, it will comply with all Applicable Law, including, as applicable, cGMP, GCP, and GLP standards, and all ethics policies agreed upon by the Parties in good faith, and will not employ or engage, and if so employed and engaged, will thereafter terminate any Person who has been Debarred/Excluded, or is the subject of any proceedings that could result in such Person being Debarred/Excluded. Zai will make all related disclosures with respect to and record all transfers of value to health care providers in the Territory to the extent required by Applicable Laws. Zai will require any Affiliate, Sublicensee, Subcontractor, or other Person that provides services to or on behalf of Zai in connection with this Agreement to comply with Zais obligations under this Section 12.4.1. |
12.4.2 | Zai will perform, and will cause its Affiliates and Sublicensees and their respective Subcontractors to, perform all necessary or required record filings with, and obtain all necessary or required licenses, approvals and permits from, all applicable Governmental Authorities in the Territory [****] for the conduct of activities, including Development activities and data sharing, under this Agreement, and provide Blueprint with copies of such record filings, licenses, approvals, and permits. |
12.4.3 | Throughout the Term, Zai or its Affiliate who will serve as Blueprints regulatory agent in the PRC will at all times meet all qualification requirements required under Applicable Law to be Blueprints regulatory agent in the PRC as contemplated by this Agreement. Zai will promptly notify Blueprint of any significant change to these qualification requirements and upon receiving any notice from any Third Party indicating, or otherwise becoming aware, that Zai or its Affiliate may not meet these requirements. |
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12.5 | Mutual Covenants. Each Party covenants to the other Party that: |
12.5.1 | Notwithstanding any provision to the contrary in this Agreement, each Party agrees as follows: |
(a) | It will not, in the performance of this Agreement, perform any actions that are prohibited by Anti-Corruption Laws that may be applicable to one or both Parties. |
(b) | It will not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party or its business in a manner that would violate Anti-Corruption Laws. |
(c) | At the request of the other Party, not more than [****], it will verify in writing to the requesting Party that to its Knowledge, there have been no violations of Anti-Corruption Laws by it or its Affiliates or Sublicensees, or persons employed by or Subcontractors used by it or its Affiliates or Sublicensees in the performance of this Agreement, or will provide details of any exception to the foregoing. |
(d) | It will maintain records (financial and otherwise) and supporting documentation related to the subject matter of this Section 12.5 (Mutual Covenants) in order to document or verify compliance with the provisions of this Section 12.5 (Mutual Covenants), and upon request of the other Party upon reasonable advance notice, will provide to such requesting Party or its representative with access to such records for purposes of verifying compliance with the provisions of this Section 12.5 (Mutual Covenants). |
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12.5.2 | It and its Affiliates will, and will cause its and their licensees subcontractors (or Sublicensees and Subcontractors, as applicable) to, comply with all Applicable Laws pertaining to Personal Information (the Privacy Laws) to which it is subject in connection with such Partys and its Affiliates, licensees (or Sublicensees, as applicable) or subcontractors (or Subcontractors, as applicable) activities related to this Agreement. To the extent that such Party or its Affiliates, licensees (or Sublicensees, as applicable), or subcontractors (or Subcontractors, as applicable) access or come into possession of Personal Information in connection with activities related to this Agreement, such Party and its Affiliates agree, and will cause its and their licensees (or Sublicensees, as applicable) and subcontractors (or Subcontractors, as applicable), to comply with applicable Privacy Laws to which it may be subject as a result thereof. Any processing (including the collection, storage, use, transfer, provision, publication, and deletion) by such Party or its Affiliates, licensees (or Sublicensees, as applicable), or subcontractors (or Subcontractors, as applicable) of Personal Information obtained in connection with activities under this Agreement will be done solely for the purpose of performing such Partys obligations or exercising such Partys rights in connection with the Development of Licensed Products consistent with the terms of this Agreement, will be in accordance with notices provided to and consents obtained from the data subjects whose Personal Information is being processed, and will be in accordance with all applicable Privacy Laws. From and after the Effective Date, each Party and its Affiliates will take, and ensure that its licensees (or Sublicensees, as applicable) and subcontractors (or Subcontractors, as applicable) take, commercially reasonable and appropriate technical and organizational measures to protect Personal Information (including the results and any clinical data obtained in connection with any Clinical Trials conducted by or on behalf of such Party) in its possession against unauthorized access, accidental loss or damage, and unauthorized destruction. Such Party and its Affiliates will further maintain, and ensure that its licensees (or Sublicensees, as applicable) and subcontractors (or Subcontractors, as applicable) maintain, a commercially reasonable program for protecting against unauthorized access to or loss, misuse, alteration, destruction, damage or disclosure of Personal Information (including the results and any clinical data obtained in connection with Clinical Trials conducted by or on behalf of such Party) in its possession pursuant to its activities under this Agreement (Data Breach). In the event of a Data Breach, such Party will (i) promptly, and in any event so as to allow the other Party to comply with its obligations under Applicable Law, notify the other Party by phone and email after becoming aware of such Data Breach, and (ii) comply with the relevant requirements and procedures of the applicable Privacy Laws in resolving such Data Breach. With respect to all activities performed by such Party and its Affiliates under the Agreement, such Party and its Affiliates will use reasonable efforts to, and to ensure that its subcontractors (or Subcontractors, as applicable), implement multi-factor authentication and encryption promptly following the Effective Date. Prior to transferring any data, files, or results containing any Personal Information to the other Party its Affiliate, subcontractor (or Subcontractor, as applicable) or licensee (or Sublicensee, as applicable) hereunder, the Parties will agree upon the manner and format of such transfer and the transferring Party will provide any required notices to and obtain any necessary consents from Governmental Authorities and data subjects prior to a transfer. With respect to such transferred data, each Party will promptly notify the other Party by phone and email after receiving a data subject request from an individual whose Personal Information was transferred to the other Party or its Affiliate, subcontractor (or Subcontractor, as applicable) or licensee (or Sublicensee, as applicable), and will comply with, and inform its Affiliates, subcontractors (or Subcontractors, as applicable) or licensees (or Sublicensees, as applicable) of the need to comply with, the relevant requirements and procedures of the applicable Privacy Laws in responding to such data subject request. Each Party will have the right, upon reasonable advance notice and at a time agreed by the Parties, to audit the other Partys and its Affiliates compliance with the requirements of this Section 12.5.2. To the extent permitted under Zais agreements with its Sublicensees or Subcontractors, Blueprint will have the right to audit the data privacy and information security measures implemented by Zais Sublicensees and Subcontractors performing activities under this Agreement. If such audit is not permitted under Zais one or more agreements with its Sublicensees or Subcontractors, Zai will use reasonable efforts to obtain the right to conduct such an audit of the data privacy and information security measures of any such Sublicensees and Subcontractors. |
12.6 | Covenants of Blueprint. Blueprint covenants to Zai that: |
12.6.1 | Neither Blueprint nor any of its Affiliates will grant any license, sublicense, or other rights in or to the Blueprint Technology that is inconsistent with the terms and conditions of this Agreement. |
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12.6.2 | During the Term Blueprint will comply with all Applicable Law applicable to its Development and Manufacture of the Blueprint Compounds and the Licensed Products pursuant to this Agreement, including, as applicable, cGMP, GCP, and GLP standards, and all ethics policies agreed upon by the Parties in good faith, and will not employ or engage, and if so employed and engaged, will thereafter terminate any Person who has been Debarred/Excluded, or is the subject of any proceedings that could result in such Person being Debarred/Excluded. |
12.7 | NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS Article 12 (REPRESENTATIONS, WARRANTIES, AND COVENANTS), (A) NO REPRESENTATION, CONDITION, OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF BLUEPRINT OR ZAI; AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT. ANY INFORMATION PROVIDED BY BLUEPRINT OR ITS AFFILIATES IS MADE AVAILABLE ON AN AS IS BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS, OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED. |
12.8 | Time for Claims. Except in the case of any fraud or intentional misrepresentation by a Party: (a) the representations and warranties of the Parties contained in Section 12.1 (Representations and Warranties of Each Party), Section 12.2 (Representations and Warranties of Blueprint), and Section 12.3 (Representations and Warranties of Zai) will survive, with respect to direct claims made by one Party against the other Party, until the date that is [****] and (b) no claim may be made or suit instituted seeking indemnification pursuant to Article 13 (Indemnification) for any breach of, or inaccuracy in, any representation or warranty contained in Section 12.1 (Representations and Warranties of Each Party), Section 12.2 (Representations and Warranties of Blueprint), or Section 12.3 (Representations and Warranties of Zai) unless a written notice is provided to the Indemnifying Party at any time prior to the date that is [****]. |
Article 13
INDEMNIFICATION
13.1 | By Zai. Zai will indemnify, defend, and hold harmless Blueprint and its Affiliates, and their respective directors, officers, employees, successors, heirs and assigns, and agents (individually and collectively, the Blueprint Indemnitee(s)) from and against all Losses incurred in connection with any Third Party Claims to the extent arising from or relating to (a) the Exploitation of the Blueprint Compounds or the Licensed Products by or on behalf of Zai or any of its Affiliates, Sublicensees, or Subcontractors, including product liability claims arising from such Exploitation, (b) Zais actions (or omissions) in the performance of its obligations with respect to Regulatory Submissions or interactions with Regulatory Authorities, in each case, as the authorized regulatory agent of record for Blueprint in the PRC, (c) the negligence or willful misconduct of Zai or any of its Affiliates, Sublicensees, or Subcontractors, (d) Zais or its Affiliates, Sublicensees, or Subcontractors breach of any of its representations, warranties, covenants, or obligations set forth in this Agreement, (e) the failure of Zai or any of its Affiliates, Sublicensees, or Subcontractors to abide by any Applicable Law, or (f) any claim or demand from any employee or contractor of Zai or its Affiliate who is an inventor of any Assigned Collaboration Technology or Joint Collaboration Technology with respect to the ownership thereof, in each case of clauses (a) through (f) above, except to the extent such Third Party Claims arise out of a Blueprint Indemnitees negligence or willful misconduct, breach of its representations, warranties, covenants, or obligations set forth in this Agreement, or failure to abide by any Applicable Law. |
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13.2 | By Blueprint. Blueprint will indemnify, defend, and hold harmless Zai, its Affiliates, and their directors, officers, employees, successors, heirs and assigns, and agents (individually and collectively, the Zai Indemnitee(s)) from and against all Losses incurred in connection with any Third Party Claims to the extent from or relating to (a) the Exploitation of the Blueprint Compounds or the Licensed Products, by or on behalf of Blueprint or any of its Affiliates, licensees (not including Zai or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors, including product liability claims arising from such Exploitation, and including such Exploitation prior to the Effective Date or after the effective date of termination of this Agreement (including when acting as an exclusive distributor pursuant to Section 15.3.2 (Appointment as Exclusive Distributor), if applicable), (b) the negligence or willful misconduct of Blueprint or any of its Affiliates, licensees (not including Zai or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors, (c) Blueprints or its Affiliates, licensees (not including Zai or its Affiliates, Sublicensees, or its Subcontractors), Sublicensees, or Subcontractors breach of any of its representations, warranties, covenants, or obligations set forth in this Agreement, (d) the failure of Blueprint or any of its Affiliates, licensees (not including Zai or its Affiliates, Sublicensees, or Subcontractors), Sublicensees, or Subcontractors to abide by any Applicable Law, or (e) any claim or demand from any employee or contractor of Blueprint or its Affiliate who is an inventor of any Joint Collaboration Technology with respect to the ownership thereof, in each case of clauses (a) through (e) above, except to the extent such Third Party Claims arise out of any of a Zai Indemnitees negligence or willful misconduct, breach of its representations, warranties, covenants, or obligations set forth in this Agreement or failure to abide by any Applicable Law. |
13.3 | Indemnification Procedure. If either Party is seeking indemnification under Section 13.1 (By Zai) or Section 13.2 (By Blueprint) (the Indemnified Party), then it will inform the other Party (the Indemnifying Party) of the Third Party Claim giving rise to such indemnification obligations within [****] after receiving written notice of the Third Party Claim (it being understood and agreed, however, that the failure or delay by an Indemnified Party to give such notice of a Third Party Claim will not affect the Indemnifying Partys indemnification obligations hereunder except to the extent the Indemnifying Party will have been actually and materially prejudiced as a result of such failure or delay to give notice). The Indemnifying Party will have the right to assume the defense of any such Third Party Claim for which it is obligated to indemnify the Indemnified Party. The Indemnified Party will cooperate with the Indemnifying Party and the Indemnifying Partys insurer as the Indemnifying Party may reasonably request, and at the Indemnifying Partys cost and expense. The Indemnified Party will have the right to participate, at its own expense and with counsel of its choice, in the defense of any Third Party that has been assumed by the Indemnifying Party. Neither Party will have the obligation to indemnify the other Party in connection with any settlement made without the Indemnifying Partys written consent, which consent will not be unreasonably withheld, conditioned, or delayed. The Indemnifying Party will not admit liability of the Indemnified Party without the Indemnified Partys prior written consent, which consent will not be unreasonably withheld, conditioned, or delayed. If the Parties cannot agree as to the application of Section 13.1 (By Zai) or Section 13.2 (By Blueprint) as to any Third Party Claim, pending resolution of the Dispute pursuant to Article 16 (Dispute Resolution), the Parties may conduct separate defenses of such Third Party Claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 13.1 (By Zai) or Section 13.2 (By Blueprint), as applicable, upon resolution of the underlying Third Party Claim. |
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13.4 | Insurance. Each Party will procure and maintain during the Term of this Agreement [****], commercial general liability insurance from a minimum of A- AM Bests rated insurance company or insurer reasonably acceptable to Blueprint, including contractual liability and product liability or clinical trials, with coverage in an amount consistent with sound business practice and industry standards, and reasonable in light of the risks involved in its activities hereunder and its obligations under this Agreement. Such policies will name the other Party and its Affiliates as additional insureds and provide a waiver of subrogation in favor of the other Party and its Affiliates. Such insurance policies will be primary and non-contributing with respect to any other similar insurance policies available to the other Party or its Affiliates. Any deductibles for such insurance will be assumed by insured Party. Each Party will provide the other Party with evidence of such insurance upon the other Partys request and prior to expiration of any one coverage. Each Party will provide the other Party with written notice at least [****] prior to the cancellation or non-renewal of, or material adverse changes in, such insurance except for cancellation due to non-payment of premiums, in which case notice will be provided at least [****] prior to such cancellation. Such insurance will not be construed to create a limit of the insured Partys liability with respect to its indemnification obligations under this Article 13 (Indemnification). |
Article 14
INTELLECTUAL PROPERTY
14.1 | Inventions. |
14.1.1 | Ownership. As between the Parties, (a) Blueprint will solely own all Blueprint Technology, including Assigned Collaboration Technology, and Blueprint Manufacturing Technology, (b) Zai will solely own all Zai Technology, and (c) the Parties will jointly own all Blueprint/Zai Combination Technology and other Joint Collaboration Technology. |
14.1.2 | Disclosure. Each Party will promptly disclose to the other Party all Inventions within the Collaboration Know-How that it develops or invents, whether solely or jointly with others (in any event, prior to the filing of any patent application with respect to such Inventions), including all invention disclosures or other similar documents submitted to such Party by its or its Affiliates employees, agents, or independent contractors relating thereto. Each Party will also promptly respond to reasonable requests from the other Party for additional information relating thereto. |
14.1.3 | Inventorship. For purposes of this Agreement, all determinations of inventorship will be in accordance with U.S. patent law. |
14.1.4 | Assignment; Ownership of Joint Collaboration Technology. |
(a) | Assigned Collaboration Technology. Zai will and hereby does assign to Blueprint all of its rights, title, and interests in and to all Assigned Collaboration Technology, and Blueprint hereby accepts such assignment. Zai will take (and cause its Affiliates, Sublicensees, Subcontractors, and their respective employees, agents, and contractors to take) such further actions reasonably requested by Blueprint to evidence such assignment and to assist Blueprint in obtaining patent and other intellectual property rights protection for Inventions within the Assigned Collaboration Know-How including executing further assignments, consents, releases, and other commercially reasonable documentation and providing good faith testimony by affidavit, declaration, in-person, or other proper means in support of any effort by Blueprint to establish, perfect, defend, or enforce its rights in any Assigned Collaboration Technology through prosecution of governmental filings, regulatory proceedings, litigation, and other means, including through the filing, prosecution, maintenance, and enforcement of the Assigned Collaboration Technology. Zai will obligate its Affiliates, Sublicensees, and Subcontractors to assign all Assigned Collaboration Technology to Zai (or directly to Blueprint) so that Zai can comply with its obligations under this Section 14.1 (Inventions), and Zai will promptly obtain such assignment. Without limitation, Zai will cooperate with Blueprint if Blueprint applies for U.S. or foreign patent protection for such Assigned Collaboration Technology and will obtain the cooperation of the individual inventors of any such Assigned Collaboration Technology. If Zai is unable to assign any Assigned Collaboration Technology, then Zai hereby grants and agrees to grant to Blueprint a royalty-free, fully paid-up, exclusive (even as to Zai, subject to the terms of this Agreement, including the licenses granted to Zai pursuant to Section 2.1 (License Grants to Zai)), perpetual, irrevocable license (with the right to grant sublicenses through multiple tiers) under such Assigned Collaboration Technology for any and all purposes. |
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(b) | Ownership of Joint Collaboration Technology. The Parties will jointly own all Blueprint/Zai Combination Technology and all other Joint Collaboration Technology, [****] (subject to the terms of this Agreement, including the licenses granted under Article 2 (Licenses) and the rights retained under such licenses pursuant to Section 2.4 (Retained Rights)). For Blueprint/Zai Combination Technology solely invented by one Party, the inventing Party will and hereby does assign to the other Party a joint interest in and to all Blueprint/Zai Combination Technology, and the other Party hereby accepts such assignment. Each Party will take (and cause its Affiliates and Sublicensees, and their respective employees, agents, and contractors to take) such further actions reasonably requested by the other Party to evidence such assignment and to assist the Parties in obtaining jointly-owned Patent Rights and other intellectual property rights protection for Inventions within the Blueprint/Zai Combination Know-How including executing further assignments, consents, releases, and other commercially reasonable documentation and providing good faith testimony by affidavit, declaration, in-person, or other proper means in support of any effort by the Parties to establish, perfect, defend, or enforce their rights in any Blueprint/Zai Combination Technology through prosecution of governmental filings, regulatory proceedings, litigation, and other means, including through the filing, prosecution, maintenance, and enforcement of the Blueprint/Zai Combination Technology. Each Party will obligate its Affiliates, Sublicensees, and Third Party contractors (including all Subcontractors) to assign all Blueprint/Zai Combination Technology to such Party so that each Party can comply with its obligations under this Section 14.1 (Inventions), and each Party will promptly obtain such assignment. Without limitation, each Party will cooperate with the other Party if the Parties determine to apply for U.S. or foreign patent protection for such Blueprint/Zai Combination Technology in accordance with this Agreement and will obtain the cooperation of the individual inventors of any such Blueprint/Zai Combination Technology. If a solely inventing Party is unable to assign a joint interest in any Blueprint/Zai Combination Technology, then such Party hereby grants and agrees to grant to the other Party a royalty-free, fully paid-up, non-exclusive (subject to the terms of this Agreement, including the licenses granted to Zai pursuant to Section 2.1 (License Grants to Zai)), perpetual, irrevocable license (with the right to grant sublicenses through multiple tiers) under such Blueprint/Zai Combination Technology for any and all purposes. |
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(c) | Practice Under and other Use of Blueprint/Zai Combination Technology and other Joint Collaboration Technology. Subject to the rights granted under and the restrictions set forth in this Agreement (including Section 2.8.1 (Exclusivity Covenant)), neither Party will have any obligation to account to the other Party for profits, or to obtain any approval of the other Party to license, assign, or otherwise exploit any Blueprint/Zai Combination Technology or other Joint Collaboration Technology by reason of joint ownership thereof, and each Party hereby waives any right it may have under the Applicable Law of any jurisdiction to require any such approval or accounting. To the extent any further consent is required to enable a Party to so license or exploit its interest in the Blueprint/Zai Combination Technology or other Joint Collaboration Technology, the other Party hereby grants such consent. |
(d) | Employee Assignment. Each Party and its respective Affiliates performing activities under this Agreement will enter into with each of their respective employees legally binding and sufficient agreements or employment policies providing for the payment by such Party or its Affiliate of any reward or remuneration required under Applicable Law in the applicable country or region in consideration for the development of Inventions by such employees. Without limiting the generality of the foregoing, each Party and its respective Affiliates will, and will cause its applicable licensees and Sublicensees, as applicable, to, enter into an agreement or employment policy with each of its employees performing activities under this Agreement that (a) compels prompt disclosure to such Party (or its licensee or Sublicensee, as applicable) of all Collaboration Technology developed, invented, or filed by such employee during any performance under this Agreement; (b) automatically assigns to such Party (or its licensee or Sublicensee, as applicable) all rights, title, and interests in and to all Collaboration Technology, and requires each employee to execute all documents and take such other actions as may be necessary to effectuate such assignment; (c) includes an invention and patent reward and remuneration policy providing for the payment by such Party of any reward or remuneration required under Applicable Law in such region in consideration for the development of Inventions by such employees that is legally sufficient under Applicable Law; and (d) solely to the extent applicable, includes a waiver of pre-emption rights under any Applicable Law in such region, including in the case of an employee in the PRC, Article 326 of the Contract Law of the PRC to the effect that the employee will confirm that he/she will not have any right or claim with respect to any Collaboration Technology derived from his/her work, except for the reward and remuneration he/she is entitled to under the invention and patent reward and remuneration policy. [****] |
(e) | Payments in Consideration of Assignments of Intellectual Property. |
(i) | Payment by Blueprint. In consideration of the assignment by Zai to Blueprint of all Assigned Collaboration Technology and a joint ownership interest in all Blueprint/Zai Combination Technology, Blueprint will pay to Zai a one-time payment of [****], which payment will be payment in-full for the assignment of all Assigned Collaboration Technology and Blueprint/Zai Combination Technology hereunder regardless of how many patent applications are filed or patents are issued Covering the Assigned Collaboration Know-How or Blueprint/Zai Combination Know-How. Blueprint will notify Zai of Blueprints filing of the first patent application claiming any Assigned Collaboration Know-How or Blueprint/Zai Combination Know-How with respect to which an employee of Zai is an inventor. Promptly thereafter, Zai will invoice Blueprint for the foregoing amount, and Blueprint will pay the undisputed invoiced amounts within [****] after the date of such invoice. The Parties expressly acknowledge that the foregoing amount is [****] and is [****]. |
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(ii) | Reward and Remuneration Payments to Employees. As between the Parties, Zai will be solely responsible for the payment of, and Zai will pay, any rewards and remuneration for inventions and technical achievements required by Applicable Law to be paid to its employees for the development or invention of any Collaboration Technology. As between the Parties, Blueprint will be solely responsible for the payment of, and Blueprint will pay, any rewards and remuneration for inventions and technical achievements required by Applicable Law to be paid to its employees for the development or invention of any Collaboration Technology. |
14.2 | Patent Prosecution. |
14.2.1 | Blueprint Patent Rights. |
(a) | Right to Prosecute. Subject to Section 14.2.3 (Joint Collaboration Technology), as between the Parties, Blueprint will have the right to control the Patent Prosecution of all Blueprint Patent Rights (including any Assigned Collaboration Patent Rights) and Blueprint Manufacturing Patent Rights throughout the world. Zai will obtain any necessary assignment documents for Blueprint with respect to the Patent Prosecution of such Patent Rights, to render all signatures that will be necessary for such patent filings, and to assist Blueprint in all other reasonably ways that are necessary for the issuance of such Patent Rights as well as for the Patent Prosecution of such Patent Rights. Zai will be responsible for [****] of the reasonable out-of-pocket costs incurred by or on behalf of Blueprint after the Effective Date with respect to the Patent Prosecution of such Patent Rights in the Territory, and will reimburse Blueprint for such costs [****] [****] after receiving an invoice with reasonable supporting documentation for such costs. Blueprint will be responsible for [****] of the out-of-pocket costs incurred by or on behalf of Blueprint with respect to the Patent Prosecution of such Patent Rights outside of the Territory. |
(b) | Review and Consult. Blueprint will consult with Zai and keep Zai reasonably informed of the Patent Prosecution of the Blueprint Patent Rights and Blueprint Manufacturing Patent Rights (following the applicable Manufacturing Technology Transfer) in the Territory and will provide Zai with all substantive correspondence received from any patent authority in the Territory in connection therewith. In addition, Blueprint will provide Zai with drafts of all proposed substantive filings in the Territory and correspondence to any patent authority in the Territory in connection with the Patent Prosecution of the Blueprint Patent Rights and Blueprint Manufacturing Patent Rights (following the applicable Manufacturing Technology Transfer) in the Territory for Zais review and comment prior to the submission of such proposed filings and correspondence. Further, Blueprint will notify Zai of any decision to cease Patent Prosecution of any Blueprint Patent Rights or Blueprint Manufacturing Patent Rights (following the applicable Manufacturing Technology Transfer) in the Territory. Blueprint will consider Zais comments on Patent Prosecution [****] and will incorporate such comments [****]. |
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(c) | Abandonment. If Blueprint decides not to continue the Patent Prosecution of a particular Blueprint Patent Right or Blueprint Manufacturing Patent Right (following the applicable Manufacturing Technology Transfer) in any region in the Territory during the Term, then it will promptly [****] provide written notice to Zai of such decision. Zai may, upon written notice to Blueprint, assume the Patent Prosecution of such Patent Right in Blueprints name [****]. In such event, (i) Blueprint will promptly deliver to Zai copies of all necessary files related to such Blueprint Patent Right or Blueprint Manufacturing Patent Right in such region(s) in the Territory and will take all actions and execute all documents reasonably necessary for Zai to assume such responsibility, (ii) Zai will continue to be responsible for [****] of the costs and expenses of the Patent Prosecution of such Patent Right, and (iii) Blueprint will have the rights to review and consult set forth in Section 14.2.1(b) (Review and Consult) mutatis mutandis (including that Zai will have final decision-making authority with respect to such Patent Prosecution activities). |
14.2.2 | Zai Collaboration Patent Rights. |
(a) | Right to Prosecute. As between the Parties, Zai will have the right to control the Patent Prosecution of all Zai Collaboration Patent Rights throughout the world. Zai will be responsible for [****] of the costs and expenses incurred with respect to the Patent Prosecution of such Patent Rights throughout the world. |
(b) | Review and Consult. Zai will consult with Blueprint and keep Blueprint reasonably informed of the Patent Prosecution of the Zai Collaboration Patent Rights inside and outside the Territory and will provide Blueprint with all substantive correspondence received from any patent authority in connection therewith. In addition, Zai will provide Blueprint with drafts of all proposed substantive filings and correspondence to any patent authority in connection with the Patent Prosecution of the Zai Collaboration Patent Rights for Blueprints review and comment prior to the submission of such proposed filings and correspondence, [****]. Further, Zai will notify Blueprint of any decision to cease Patent Prosecution of any Zai Collaboration Patent Rights inside or outside the Territory. Zai will consider Blueprints comments on Patent Prosecution [****] and will incorporate such comments [****]. |
(c) | Abandonment. If Zai decides not to continue the Patent Prosecution of a particular Zai Collaboration Patent Right in any country or region inside or outside the Territory during the Term, then it will promptly [****] provide written notice to Blueprint of such decision. Blueprint may, upon written notice to Zai, assume such Patent Prosecution of such Zai Collaboration Patent Right in Zais name [****]. In such event, (i) Zai will promptly deliver to Blueprint copies of all necessary files related to such Zai Collaboration Patent Right in such country(ies) or region(s) and will take all actions and execute all documents reasonably necessary for Blueprint to assume such responsibility, (ii) Blueprint will then be responsible for [****] of the future costs and expenses of the Patent Prosecution of such Patent Right, and (iii) Zai will have the rights to review and consult set forth in Section 14.2.2(b) (Review and Consult) mutatis mutandis (including that Blueprint will have final decision-making authority with respect to such Patent Prosecution activities). |
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14.2.3 | Joint Collaboration Technology. |
(a) | Joint Collaboration Technology and Blueprint/Zai Combination Technology. Unless otherwise agreed upon by the Parties in connection with the JSCs approval of any Blueprint/Zai Combination, the provisions of this Section 14.2.3(a) (Joint Collaboration Technology and Blueprint/Zai Combination Technology) will apply with respect to the Patent Prosecution of the Blueprint/Zai Combination Patent Rights in addition to the other Joint Collaboration Patent Rights. Blueprint will control the Patent Prosecution of any Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Rights outside of the Territory, and Zai will control the Patent Prosecution of any Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Right inside of the Territory, provided that Blueprint will control [****]. The Parties will use [****] to agree on a mutually acceptable strategy for the Patent Prosecution of the Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Rights and will ensure that the external counsels engaged by each Party for the Patent Prosecution of such Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Rights coordinate with each other with respect to such Patent Prosecution of the Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Rights inside and outside of the Territory (including with respect to the timing of the filing of patent applications inside and outside of the Territory). The Party with the right to control the Patent Prosecution of any Blueprint/Zai Combination Patent Rights and any other Joint Collaboration Patent Right pursuant to this Section 14.2.3(a) (Joint Collaboration Technology and Blueprint/Zai Combination Technology) (the Prosecuting Party) will be responsible for the costs and expenses incurred with respect to the Patent Prosecution of such Patent Rights in their respective territory[****]. |
(b) | Review and Consult. The Prosecuting Party will consult with the other Party and keep the other Party reasonably informed of the Patent Prosecution of the Joint Collaboration Patent Rights in its respective territory and will provide the other Party with all substantive correspondence received from any patent authority in such territory in connection therewith. In addition, the Prosecuting Party will provide the other Party with drafts of all proposed substantive filings and correspondence to any patent authority in its respective territory in connection with the Patent Prosecution of the Joint Collaboration Patent Rights for the other Partys review and comment prior to the submission of such proposed filings and correspondence. Further, the Prosecuting Party will notify the other Party of any decision to cease Patent Prosecution of any of the Joint Collaboration Patent Rights in its respective territory. The Prosecuting Party will consider the other Partys comments on Patent Prosecution but will have final decision-making authority under this Section 14.2.3(b) (Review and Consult). |
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(c) | Abandonment. If the Prosecuting Party decides not to continue the Patent Prosecution of a particular Joint Collaboration Patent Right in its respective territory during the Term, then it will promptly [****] provide written notice to the other Party of such decision. The other Party may, upon written notice to the Prosecuting Party, assume the Patent Prosecution of such Patent Right in the applicable territory. In such event, (i) such Party will [****] deliver to the other Party copies of all necessary files related to such Joint Collaboration Patent Right in such country(ies) or region(s) and will take all actions and execute all documents reasonably necessary for the other Party to assume such responsibility, (ii) the other Party will become the Prosecuting Party with respect to such Joint Collaboration Patent Rights in the applicable territory, (iii) the other Party will be responsible for [****] of the out-of-pocket costs incurred by the Prosecuting Party as set forth under Section 14.2.3(a) (Joint Collaboration Technology and Blueprint/Zai Combination Technology), and (iv) the other Party (that is no longer the Prosecuting Party) will retain the rights to review and consult set forth in Section 14.2.3(b) (Review and Consult). |
14.2.4 | Cooperation. Each Party will provide the other Party all reasonable assistance and cooperation in the Patent Prosecution efforts under this Section 14.2 (Patent Prosecution), including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution. |
14.3 | Patent Enforcement. |
14.3.1 | Notice. Each Party will notify the other within [****] of becoming aware of any alleged or threatened infringement by a Third Party of any of the (a) Blueprint Patent Rights or Blueprint Manufacturing Patent Rights in the Territory, (b) Zai Collaboration Patent Rights in the Territory, or (c) Blueprint/Zai Combination Patent Rights or other Joint Collaboration Patent Rights in the Territory, and, in each case, any related declaratory judgment or equivalent action alleging the invalidity, unenforceability, or non-infringement of such Patent Rights (collectively Product Infringement). For clarity, Product Infringement excludes any adversarial Patent Prosecution proceedings. |
14.3.2 | Enforcement Rights. |
(a) | First Right; Step-In. |
(i) | Blueprint First Right. Unless otherwise agreed by the Parties in writing, Blueprint will have the first right to bring and control any legal action to enforce any Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights other than the Blueprint/Zai Combination Patent Rights against any Product Infringement in the Territory as it reasonably determines appropriate, [****] and Blueprint will consider [****] the interests of Zai in such enforcement. [****] |
(ii) | Zai First Right. Zai will have the first right to bring and control any legal action to enforce the Blueprint/Zai Combination Patent Rights and Zai Collaboration Patent Rights against any Product Infringement in the Territory as it reasonably determines appropriate, [****] and Zai will consider [****] the interests of Blueprint in such enforcement. The Party with the first right to bring and control any legal action to enforce the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, Zai Collaboration Patent Rights, Blueprint/Zai Combination Patent Rights, or other Joint Collaboration Patent Rights, as applicable, will be referred to herein as the Controlling Party. |
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(iii) | Step-In Rights. If the Controlling Party or its designee fails to abate such Product Infringement in the Territory or to file an action to abate such Product Infringement in the Territory related to Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, Zai Collaboration Patent Rights, or Joint Collaboration Patent Rights (including Blueprint/Zai Combination Patent Rights) within [****] after a written request from the other Party to do so, or if the Controlling Party discontinues the prosecution of any such action after filing without abating such infringement, then, in either case, the other Party will have the right, at such other Partys cost and expense, to enforce the applicable Patent Rights against such Product Infringement in the Territory as it reasonably determines appropriate provided that (A) the Controlling Party does not provide reasonable rationale for not doing so or continuing to do so (including a substantive concern regarding counter-claims by the infringing Third Party), and (B) the other Party will not enter into any settlement admitting the invalidity of, or otherwise impairing, any such Patent Rights without the prior written consent of the Controlling Party. |
(iv) | Zais Rights. Zai will have the sole right to bring and control any legal action to enforce Zai Patent Rights (other than Zai Collaboration Patent Rights) against any Product Infringement in the Territory at its own expense as it reasonably determines appropriate. Zai will not have the right to enforce any Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, Zai Collaboration Patent Rights, Blueprint/Zai Combination Patent Rights, or other Joint Collaboration Patent Rights outside of the Territory. |
14.3.3 | Cooperation. At the request of the Party bringing an action related to a Product Infringement, the other Party will provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery, and joining as a party to the action if required by Applicable Law to pursue such action. |
14.3.4 | Recoveries. Any recoveries resulting from an enforcement action relating to a claim of Product Infringement in the Territory will be first applied against payment of each Partys costs and expenses in connection therewith. Any such recoveries relating to a claim of Product Infringement in the Territory in excess of such costs and expenses will be split as follows: [****]. |
14.4 | Infringement of Third Party Rights. |
14.4.1 | Notice. If any Licensed Product used, sold, or manufactured (if applicable) by Zai or its Affiliates or Sublicensees becomes the subject of a Third Partys claim or assertion of infringement of a Patent Right or other rights in the Territory that are owned or controlled by such Third Party, then Zai will promptly notify Blueprint within [****] after receipt of such claim or assertion and will include in such notice a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Thereafter, the Parties will promptly meet to consider the claim or assertion and the appropriate course of action and may, if appropriate, agree on and enter into a common interest agreement wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. The Parties will assert and not waive the joint defense privilege with respect to any communications between the Parties in connection with the defense of such claim or assertion. |
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14.4.2 | Defense. Subject to any indemnification obligations under Section 13.2 (By Blueprint), Zai will be solely responsible for the defense of any such infringement claims brought against Zai[****]; provided that Zai will not agree to any settlement, consent to judgment, or other voluntary final disposition in connection with such defense action, in each case, without Blueprints prior written consent (which consent will not be unreasonably delayed, withheld, or conditioned) if such settlement, consent to judgment, or other voluntary final disposition would (a) result in the admission of any liability or fault on behalf of Blueprint, (b) result in or impose any payment obligations upon Blueprint, or (c) subject Blueprint to an injunction or otherwise limit Blueprints ability to take any actions or refrain from taking any actions under this Agreement or with respect to any Blueprint Compound or Licensed Product. Zai will keep Blueprint informed on the status of such defense action, and Blueprint will have the right, but not the obligation, to participate and be separately represented in such defense action at its sole option and at its own expense. |
14.5 | Patents Licensed from Third Parties. Each Partys rights under this Article 14 (Intellectual Property) with respect to the Patent Prosecution and enforcement of any Patent Right that is in-licensed by Blueprint or Zai from a Third Party will be subject to the rights of such Third Party to prosecute, enforce, and defend such Patent Right. |
14.6 | Patent Listings. With respect to patent listings in any patent listing system established by any applicable Regulatory Authority in a region in the Territory or under Applicable Law, including, (a) in the PRC, under Article 76 of the Patent Law of the PRC and its implementing measures and interpretations promulgated by relevant PRC Governmental Authorities, including the National Medical Products Administration (NMPA), the China National Intellectual Property Administration (CNIPA), and the Supreme Peoples Court, and (b) other equivalents thereof in the Territory, for Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Collaboration Patent Rights Covering any Licensed Product, the Parties will discuss and agree which Patent Rights to list in such patent listing in such region (the Listing Patents) (i) prior to the submission of the first and any subsequent MAA for such Licensed Product in such region to such applicable Regulatory Authority, (ii) within [****], but in any event reasonably in advance of the deadline for listing under Applicable Laws, after the receipt of the first and any subsequent Regulatory Approval in such region for such Licensed Product from such Regulatory Authority, including any additional Indication for such Licensed Product, (iii) within [****], but in any event reasonably in advance of the deadline for listing under Applicable Laws, after the issuance in such region of a patent included in the Listing Patents, and (iv) within [****] following the submission of a new patent application in such region Covering any Licensed Product included in the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Collaboration Patent Rights that has not been previously considered in any prior discussion and agreement of the Parties regarding Listing Patents; provided that, except as otherwise permitted under Applicable Laws, the Party holding the MAA for such Licensed Product in the Territory will not list, and will not be obligated to list, as of the date of listing, (A) any unissued patent, (B) any Patent Right that does not Cover the Licensed Product, (C) any patent that is of a type or that contains patent claims that are of a type not permitted to be listed under Applicable Law, or (D) any patent that such Party knows or has a reasonable basis to know is reasonably likely to be declared invalid by a competent Governmental Authority in such region. In furtherance of the foregoing clause (D), if either Party has such knowledge or reasonable basis, such Party will promptly notify and inform the Party of all facts and circumstances it is aware of underlying such knowledge or reasonable basis. In the event the Parties are unable to agree on which Patent Rights to list by the time required as provided under clause (i) to (iv) above, subject to the above proviso, Blueprint will have the final decision-making right over whether the Party holding the MAA for the applicable Licensed Product in the Territory will list any Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights, and Zai will have the final decision-making right over whether the Party holding the MAA for the applicable Licensed Product in the Territory will list any issued patents included in the Zai Collaboration Patent Rights. The Party holding the MAA for the applicable Licensed Product in the Territory will promptly, and in any event at least [****] prior to the applicable deadline for listing under Applicable Laws, list the Listing Patents in the applicable patent listing system in the applicable regions in the Territory provided, that, without limiting the foregoing, if the Party holding the MAA for the applicable Licensed Product in the Territory has not listed the Listing Patents in the patent listing system of an applicable region before [****] prior to the deadline for listing in the applicable region, then the other Party may list the Listing Patents at anytime when permitted by Applicable Laws by providing prior written notice to the Party holding the MAA for the applicable Licensed Product in the Territory. The Party holding the MAA for the applicable Licensed Product in the Territory will provide copies of all documentation to be filed in connection with any such listing of Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights to the other Party prior to filing thereof and will consider the other Partys comments with respect to such documentation in good faith. The Party holding the MAA for the applicable Licensed Product in the Territory will cooperate with the other Party to the extent reasonably requested by the other Party to effectuate the intent of this Section 14.6 (Patent Listings), including providing all documentation, certifications, and consents necessary to effectuate the foregoing and setting up an account to list patents on the applicable patent listing system, and granting the other Party access to and a right to use such account as reasonably necessary to effectuate the intent of this Section 14.6 (Patent Listings). Neither Party will list any patent in any patent listing system in a region in the Territory for the Licensed Product, except in accordance with this Section 14.6 (Patent Listings). |
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14.7 | Patent Term Extensions. With respect to any system for extending the term of Patent Rights in the Territory due to the time needed to obtain Regulatory Approval of a pharmaceutical product established by any applicable Regulatory Authority in any region in the Territory (a Patent Term Extension), adjusting the term of Patent Rights in the Territory due to the time needed to prosecute and obtain a grant of a Patent Right under Applicable Laws in any region in the Territory (a Patent Term Adjustment), or supplementary protection certificates and any other extensions that are now or become available in the future under Applicable Laws in any region in the Territory (Other Extensions), (a) Blueprint will have the right, but not the obligation, and will be solely responsible for making all decisions regarding Patent Term Extensions, Patent Term Adjustments, or Other Extensions in the Territory that are applicable to Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights and that become available directly as a result of the Regulatory Approval of a Licensed Product in the Territory or following issuance of a patent included in the Blueprint Patent Rights, Blueprint Manufacturing Patent Rights, or Joint Collaboration Patent Rights provided that Blueprint will consult with Zai with respect to such decisions and consider [****] the reasonable comments and concerns raised by Zai; and (b) Zai will have the right, but not the obligation, and will be solely responsible for making all decisions regarding Patent Term Extensions, Patent Term Adjustments, and Other Extensions in the Territory that are applicable to Zai Collaboration Patent Rights and that become available directly as a result of the Regulatory Approval of a Licensed Product in the Territory or following issuance of a patent included in the Zai Collaboration Patent Rights; provided that Zai will consult with Blueprint with respect to such decisions and consider [****] the reasonable comments and concerns raised by Blueprint. The Party holding the MAA for the applicable Licensed Product in the Territory will make the appropriate filings and applications in the Territory in order to effectuate each Partys decisions regarding Patent Term Extensions, Patent Term Adjustments, or Other Extensions in the Territory in accordance with the foregoing sentence. The Party holding the MAA for the applicable Licensed Product in the Territory will cooperate with the other Party to the extent reasonably requested by the other Party to effectuate the intent of this Section 14.7 (Patent Term Extensions), including providing to the other Party all documentation, certifications, and consents necessary to make and prosecute such application and obtain such Patent Term Extension, Patent Term Adjustment, or Other Extension. |
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14.8 | Filing of Agreement with CNIPA. The Parties will file a redacted copy of this Agreement with the CNIPA as required by Applicable Law in the Territory no later than the date required under such Applicable Law. |
14.9 | Product Trademarks. |
14.9.1 | Global Brand Elements. Zai acknowledges that Blueprint may decide to develop and adopt certain distinctive colors, logos, images, symbols, and trademarks to be used in connection with the Commercialization of each Licensed Product on a global basis (such trademarks, the Product Marks and such other branding elements together with the Product Marks, collectively, the Global Brand Elements). Blueprint will and hereby does grant Zai the exclusive right to use such Global Brand Elements in connection with the Commercialization of each Licensed Product in the Field in the Territory in accordance with the applicable Commercialization Plan. |
14.9.2 | Product Marks in the Territory. Zai will brand the Licensed Products in the Territory using Blueprints Global Brand Elements; provided, however, a Product Mark may deviate from Blueprints Global Brand Elements if (a) the JSC determines such Product Mark is not appropriate for the Territory due to linguistic reasons or market research showing that such Product Mark is not appropriate, (b) a Governmental Authority rejects or refuses such Product Mark for use in the Territory or such Product Mark is not registrable in the Territory, or (c) Zai reasonably desires alternative or additional trademarks in the applicable local language in the Territory. In the event of the foregoing (a), (b), or (c), Zai may select an alternative Licensed Product-specific trademark to use in connection with the Commercialization of Licensed Products in the Territory and will provide any such proposed Licensed Product-specific trademark to the JSC for review and comment prior to finally selecting and using any such proposed Licensed Product-specific trademark. Zai will not use any trademarks of Blueprint (including Blueprints corporate name) or any trademark confusingly similar thereto without Blueprints prior written consent. Following review thereof by the JSC, such Licensed Product-specific trademark will become a Product Mark for all purposes under this Agreement. |
14.9.3 | Ownership. Blueprint will be the sole and exclusive owner of all Product Marks and Global Brand Elements, including all trademark registrations and applications therefor and all goodwill associated therewith. To the extent Zai acquires any rights, title, or interests in or to any Product Mark or Global Brand Element (including any trademark registration or application therefore or goodwill associated with any Product Mark), Zai will, and hereby does, assign the same to Blueprint. Blueprint will and hereby does grant Zai the exclusive right to use such Product Marks in connection with the Commercialization of the applicable Licensed Product in the Territory. Upon Zais request, Blueprint will register and maintain the Product Marks in the Territory using counsel of Blueprints choice and [****]. |
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14.9.4 | Use. Zai agrees that it and its Affiliates and Sublicensees will Commercialize each of the Licensed Products in the Territory in a manner consistent with the Global Brand Elements and will: (a) ensure that all Licensed Products that are sold bearing the Product Marks and Global Brand Elements are of a high quality consistent with industry standards for global pharmaceutical and biologic therapeutic products; (b) ensure that each use of the Global Brand Elements and Product Marks by Zai and its Affiliates and Sublicensees is accompanied by an acknowledgement that such Global Brand Elements and Product Marks are owned by Blueprint; (c) not use such Global Brand Elements or Product Marks in a way that might materially prejudice their distinctiveness or validity or the goodwill of Blueprint therein and includes the trademark registration symbol ® or as appropriate; (d) not use any trademarks or trade names so resembling any of such Global Brand Elements or Product Marks as to be likely to cause confusion or deception; and (e) place and display the Global Brand Elements and the Product Marks on and in connection with the Licensed Products in a way that acknowledges Blueprints role in discovering the Licensed Products and that such Licensed Product is under license from Blueprint. To the extent permitted by and consistent with Applicable Law, Zai will include the words (a) Discovered by Blueprint Medicines Corporation (or such other similar text provided by Blueprint and reasonably acceptable to Zai) on all packaging and labeling for any Licensed Product that is not a Blueprint/Zai Combination and in relevant scientific, medical, and other Licensed Product-related communications to the extent such communications address the Development or Commercialization of such a Licensed Product (that is not a Blueprint/Zai Combination), and (b) Discovered in Collaboration by Blueprint Medicines Corporation and Zai Pharmaceuticals (or such other similar text provided by Blueprint and reasonably acceptable to Zai) on all packaging and labeling for any Blueprint/Zai Combination (to the extent feasible, for example, if the Zai Product and the Blueprint Compound are co-packaged) and in relevant scientific, medical, and other Blueprint/Zai Combination-related communications to the extent such communications address the Development or Commercialization of a Blueprint/Zai Combination, in each case ((a) and (b)), in English unless required under Applicable Law to be in another language. |
14.10 | Patent Marking. Zai will mark all Licensed Products in accordance with the applicable patent marking laws, and will require all of its Affiliates and Sublicensees to do the same. To the extent permitted by Applicable Law, Zai will indicate on the product packaging, advertisement and promotional materials that such Licensed Product is in-licensed from Blueprint. |
Article 15
TERM AND TERMINATION
15.1 | Term. This Agreement will be effective as of the Effective Date, and will continue, on a Licensed Product-by-Licensed Product and region-by-region basis, in effect until the expiration of all payment obligations set forth under this Agreement with respect to such Licensed Product in such region (the Term). On a Licensed Product-by-Licensed Product and region-by-region basis, upon the natural expiration of this Agreement as contemplated in this Section 15.1 (Term), so long as at such time Zai has paid to Blueprint all undisputed amounts due under this Agreement and accrued prior to such natural expiration of the Term in accordance with the terms hereof and is not at such time in material breach of any term of this Agreement, the licenses granted to Zai under Section 2.1 (License Grants to Zai) will become non-exclusive, perpetual, and irrevocable. |
15.2 | Termination. |
15.2.1 | Termination by Zai for Convenience. Zai may terminate this Agreement in its entirety by providing a written notice of termination to Blueprint after the [****] anniversary of the Effective Date that includes an effective date of termination [****]. |
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15.2.2 | Termination for Material Breach. |
(a) | Notice and Cure Period. If either Party believes in good faith that the other is in material breach of any term of this Agreement, then the non-breaching Party may deliver notice of such breach to the other Party stating the cause and proposed remedy (Breach Notification). For any breach arising from a failure to make a payment set forth in this Agreement, the allegedly breaching Party will have [****] from the receipt of the applicable Breach Notice to dispute or cure such breach. If the Party receiving notice of breach fails to cure, or fails to dispute, that breach within the applicable period set forth above, then the Party originally delivering the Breach Notification may terminate this Agreement effective on written notice of termination to the other Party. For all breaches other than a failure to make a payment as set forth in this Agreement, the allegedly breaching Party will have [****] from the date of the Breach Notification to dispute or cure such breach, provided that if such breach (other than a payment breach) is not reasonably capable of cure within such [****] period, but is capable of cure within [****] from the date of such Breach Notification, then the breaching Party may submit, within [****] of such Breach Notification, a reasonable cure plan to remedy such breach as soon as possible and in any event prior to the end of such [****] period that is reasonably acceptable to the non-breaching Party, and, upon such submission, the [****] cure period will be automatically extended for so long as the breaching Party continues to use reasonable efforts to cure such breach in accordance with the cure plan, but for no more than [****]. Notwithstanding the foregoing, if the allegedly breaching Party disputes in good faith the existence or materiality of the alleged breach, then the other Party will not have the right to terminate this Agreement unless and until an arbitrator issues a final award pursuant to Section 16.3 (Arbitration) that the allegedly breaching Party has materially breached a term of this Agreement. During the pendency of such a dispute, all of the terms of this Agreement will remain in effect and the Parties will continue to perform all of their respective obligations hereunder. The cure period will be tolled starting as of the date of such notice of a dispute from the allegedly breaching Party and for the remainder of the pendency of any such dispute and such breaching Party will have the time remaining of the applicable cure period to cure the applicable breach after such award finding such breach is issued. |
15.2.3 | Termination for Patent Challenge. Except to the extent unenforceable under the Applicable Law, Blueprint may terminate this Agreement by providing written notice of termination to Zai if Zai or its Affiliates or Sublicensees (individually or in association with any Person) contests or assists a Third Party in contesting the scope, validity, or enforceability of any Blueprint Patent Right, Blueprint Manufacturing Patent Right, or Joint Collaboration Patent Right anywhere in the world in any court, tribunal, arbitration proceeding, or other proceeding, including the U.S. Patent and Trademark Office and the U.S. International Trade Commission (a Patent Challenge) unless Zai or its applicable Affiliate withdraws, cancels, or otherwise terminates such Patent Challenge within [****] following the earlier of (a) Blueprints notice or (b) the date on which Zai or its applicable Affiliate had written notice, or otherwise first became aware (as evidenced by written records), of such Patent Challenge[****] if: (i) [****] or (ii) [****] this Section 15.2.3 [****] As used herein, a Patent Challenge includes: (A) filing an action under 28 U.S.C. §§ 2201-2202 seeking a declaration of invalidity or unenforceability of any such Patent Right; (B) filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter partes review of any such Patent Right; (C) filing, or joining in, a petition under 35 U.S.C. § 321 to institute post-grant review of any such Patent Right or any portion thereof; (D) filing or commencing any opposition, nullity, or similar proceedings challenging the validity of any such Patent Right in any country or region; or (E) any foreign equivalent of clauses (A), (B), (C), or (D) [****]. |
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15.2.4 | Cessation of Development and Commercialization. If Zai and its Affiliates do not conduct any material Development or Commercialization activities with respect to one or more Licensed Products [****], and such suspension of activity is not: [****] then Blueprint may, at its election, terminate this Agreement upon [****] prior written notice to Zai if Zai does not commence material Development or Commercialization activities with respect to one or more Licensed Products before the expiration of such [****] notice period. Notwithstanding the foregoing, if Blueprint gives a notice of termination to Zai pursuant to this Section 15.2.4 (Cessation of Development or Commercialization), and Zai provides notice during such [****] period that it disputes the basis for termination pursuant to this Section 15.2.4 (Cessation of Development or Commercialization), then this Agreement will not terminate unless and until an arbitrator issues a final award pursuant to Section 16.3 (Arbitration) upholding such basis for termination. During the pendency of such a dispute, all of the terms of this Agreement will remain in effect and the Parties will continue to perform all of their respective obligations hereunder. The [****] notice period will be tolled starting as of the date of such notice of a dispute from Zai and for the remainder of the pendency of any such dispute and Zai will have the time remaining of the notice period to commence material Development or Commercialization activities with respect to one or more Licensed Products after the arbitrator has upheld the basis for termination. |
15.2.5 | Termination for Insolvency. Each Party will have the right to terminate this Agreement upon delivery of written notice to the other Party if (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [****] of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors. |
15.2.6 | Full Force and Effect During Notice Period. This Agreement will remain in full force and effect until the expiration of the applicable termination notice period. For clarity, if Zai or any of its Affiliates or Sublicensees achieve any Milestone Event during the termination notice period, then the corresponding Milestone Payment is accrued and Zai will remain responsible for the payment of such Milestone Payment even if the due date of such Milestone Payment occurs after the effective date of the termination. |
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15.3 | Effect of Termination. Upon the termination of this Agreement (but not expiration of this Agreement): |
15.3.1 | Licenses. As of the effective date of termination of this Agreement (but not expiration of this Agreement), all licenses and all other rights granted by Blueprint to Zai under the Blueprint Technology and Blueprint Manufacturing Technology will terminate and all sublicenses granted by Zai pursuant to Section 2.2 (Sublicensing and Subcontractors) will also terminate. Each Party will retain its joint ownership interests in the Joint Collaboration Technology. In addition, upon the termination of this Agreement (but not expiration of this Agreement) Blueprint will have, and Zai hereby grants to Blueprint, effective upon such termination, a worldwide, exclusive, perpetual, royalty-bearing [****] and sublicenseable (through multiple tiers) license under the Zai Technology, Zais interests in the Joint Collaboration Technology and any Zai Identified Rights, in each case, Controlled by Zai as of the effective date of such termination and solely to Exploit the Licensed Products (in the form that such Licensed Products exist as of the effective date of termination). In addition to [****], subject to Blueprints right to decline a license or sublicense of Zai In-Licensed Rights in accordance with the terms of Section 2.6.6(b) (Right to Decline Zai In-Licensed Rights) or by providing written notice to Zai within [****] of the effective date of termination of this Agreement declining such rights, Blueprint will reimburse Zai for amounts owed under such Zai Third Party IP Agreement in accordance with Section 2.6.6(c) (Responsibility for Costs of Zai In-Licensed Rights). In addition, Zai will assign to Blueprint any Third Party IP Agreement pursuant to which Zai then Controls any Zai Identified Rights, if such Third Party IP Agreement is specific to the terminated Licensed Product and if permitted under such Third Party IP Agreement (and will use reasonable efforts to seek any consent required from the applicable Third Party in connection with such an assignment). If such Third Party IP Agreement cannot be assigned to Blueprint, then upon Blueprints reasonable request, Zai will maintain such Third Party IP Agreement and Blueprint will pay to Zai [****] of all payments due to the applicable Third Party under any such Third Party IP Agreement in consideration of the sublicense to Blueprint and Blueprints Exploitation of such Zai Identified Rights. If Zai is unable to sublicense any Zai Identified Rights to Blueprint pursuant to this Section 15.3.1 (Effect of Termination; Licenses) without the consent of the Third Party, then Zai undertakes, on request from Blueprint, to use reasonable efforts to procure such licenses with respect to the applicable Licensed Products on behalf of Blueprint to the extent that it is able to do so, and Blueprint will pay such fees and agree to be bound by the terms agreed between Zai and the Third Party licensor. |
15.3.2 | Appointment as Exclusive Distributor. If Zai is Commercializing any Licensed Product in any region in the Territory as of the effective date of termination of this Agreement (but not expiration of this Agreement), then, at Blueprints election (in its sole discretion) in the event of termination of this Agreement by Blueprint pursuant to Section 15.2.2 (Termination for Material Breach), Section 15.2.5 (Termination for Insolvency), or Section 15.2.4 (Cessation of Development and Commercialization), by Zai pursuant to Section 15.2.1 (Termination by Zai for Convenience), or in all other cases, at Zais election (in its sole discretion), on a region-by-region basis in the Territory, until such time as all Regulatory Approvals with respect to such Licensed Product in such region have been assigned and transferred to Blueprint, either (a) Zai will (with Blueprints consent in the event such election is made by Zai) appoint Blueprint or its designee as its exclusive distributor of such Licensed Product in such region and grant Blueprint or its designee the right to appoint sub-distributors, to the extent not prohibited by any written agreement between Zai or any of its Affiliates and a Third Party; provided that Blueprint will purchase any and all salable inventory of the Licensed Product held by Zai or its Affiliates as of the effective date of termination [****] or (b) Zai will have the continued right to sell the Licensed Product in such region from its inventory; provided, however, that Zais obligations under this Agreement with respect to all such Licensed Product that Zai sells following termination, including the obligation to remit Royalty Payments to Blueprint hereunder, will continue in full force and effect during such period. |
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15.3.3 | Regulatory Submissions and Regulatory Approvals. To the extent requested by Blueprint following the date that a Party provides notice of termination of this Agreement (but not expiration of this Agreement), Zai will and hereby does, and will cause its Affiliates and Sublicensees to, (a) [****] assign and transfer to Blueprint or its designee all of Zais rights, title, and interests in and to all Regulatory Submissions and Regulatory Approvals for Licensed Products then owned or Controlled by Zai or any of its Affiliates or Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Blueprint to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Zai with respect to a Licensed Product. Zai will take all steps necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Blueprint, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Blueprint) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. In addition, upon Blueprints written request, Zai will [****] provide to Blueprint copies of all material related documentation, including material non-clinical, preclinical, and clinical data that are held by or reasonably available to Zai or its Affiliates or Sublicensees. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Blueprint will assume all safety and safety database activities with respect to all Licensed Products no later than [****] after the effective date of termination of this Agreement. |
15.3.4 | Assignment and Disclosure. To the extent requested by Blueprint following the date that a Party provides notice of termination of this Agreement, Zai will promptly upon request (and in any event within [****]): |
(a) | assign and transfer to Blueprint or its designee all of Zais rights, title, and interests in and to all clinical trial agreements, manufacturing and supply agreements, and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, data and other Know-How (including commercial information) in Zais Control, in each case, relating solely to any Licensed Product and that are necessary or useful for the Exploitation of any Licensed Product; |
(b) | disclose to Blueprint or its designee all documents, records, and materials related to Licensed Products that are controlled by Zai or that Zai is able to obtain using reasonable efforts, and that embody the foregoing; and |
(c) | assign and transfer to Blueprint or its designee all of Zais rights, title, and interests in and to any promotional materials, training materials, medical education materials, packaging and labeling, and all other literature or other information solely related to Licensed Products and copyrights and any registrations for the foregoing. |
Unless this Agreement is terminated by Zai pursuant to Section 15.2.2 (Termination for Material Breach) or Section 15.2.5 (Termination for Insolvency), the costs and expenses associated with the assignments set forth in this Section 15.3.4 (Assignment and Disclosure) will be borne by Zai. To the extent that any agreement or other asset described in this Section 15.3.4 (Assignment and Disclosure) is not assignable by Zai, then such agreement or other asset will not be assigned, and upon the request of Blueprint, Zai will take such steps as may be necessary to allow Blueprint to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Zai has the right and ability to do so. For clarity, Blueprint will have the right to request that Zai take any or all of the foregoing actions in whole or in part, or with respect to all or any portion of the assets set forth in this Section 15.3.4 (Assignment and Disclosure).
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15.3.5 | Regulatory Transfer Support. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to Section 15.3.3 (Regulatory Submissions and Regulatory Approvals) and Section 15.3.4 (Assignment and Disclosure), Zai will appoint Blueprint as Zais or its Affiliates agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Blueprints or its Affiliates name have been assigned to Blueprint or its designee. In the event of failure to obtain such assignment, Zai hereby consents and grants to Blueprint the right to access and reference (without any further action required on the part of Zai, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Products. |
15.3.6 | Know-How Transfer Support. In furtherance of the assignment of Know-How pursuant to Section 15.3.4 (Assignment and Disclosure) and in addition to the requirements in Section 15.3.9 (Supply Following Termination), Zai will for a period of [****] from the effective date of termination of this Agreement, provide such consultation or other assistance as Blueprint may reasonably request to assist Blueprint in becoming familiar with such Know-How in order for Blueprint to undertake further Exploitation of the Licensed Products following termination of this Agreement [****]. |
15.3.7 | Inventory. At Blueprints election and request, Zai will transfer to Blueprint or its designee some or all inventory of each Licensed Product (including all final product, bulk drug substance, intermediates, works-in-process, formulation materials, reference standards, drug product clinical reserve samples, packaged retention samples, and the like) then in the possession or Control of Zai, its Affiliates or Sublicensees; provided that Blueprint will [****] and provided further that Zai may retain inventory to the extent retained to exercise its rights under Section 15.3.2 (Appointment of Exclusive Distributor). |
15.3.8 | Wind Down and Transition. Zai will be responsible, [****] for the wind-down of Zais and its Affiliates and its Sublicensees Exploitation of all Licensed Products. Zai will, and will cause its Affiliates and Sublicensees to, reasonably cooperate with Blueprint to facilitate orderly transition of the Exploitation of each Licensed Product to Blueprint or its designee, including (a) assigning or amending as appropriate, upon request of Blueprint, any agreements or arrangements with Third Party vendors (including distributors) solely related to the Exploitation of each Licensed Product or, to the extent any such Third Party agreement or arrangement is not assignable to Blueprint, reasonably cooperating with Blueprint to arrange to continue to provide such services for a reasonable time after termination of this Agreement; and (b) to the extent that Zai or its Affiliate is performing any activities described in the foregoing clause (a), reasonably cooperating with Blueprint to transfer such activities to Blueprint or its designee and continuing to perform such activities on Blueprints behalf for a reasonable time after termination of this Agreement until such transfer is completed. |
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15.3.9 | Supply Following Termination. If, as of the effective date of termination of this Agreement, Blueprint has completed the Manufacturing Technology Transfer for a one or more Licensed Products and Zai is Manufacturing one or more such Licensed Products, then at Blueprints written request, Zai will supply to Blueprint such quantities of such Licensed Product (in bulk drug substance, bulk drug product, or finished drug product form, as requested by Blueprint, to the extent within Zais then current capacity restrictions as of the effective date of termination) as Blueprint indicates in written forecasts and orders therefor from time to time [****] until [****] (a) [****] and (b) [****]. In addition, upon Blueprints request, Zai will (i) provide a [****] technology transfer to Blueprint or its designee of information and materials [****] for Blueprint or its designee to Manufacture such Licensed Product in each formulation of such Licensed Product (as it exists at the time of termination of this Agreement and to the extent such information was not previously transferred by or on behalf of Blueprint to Zai or its Affiliate or designee), including providing reasonable assistance to Blueprint or its designee in connection therewith upon request, and (ii) assign to Blueprint any agreement that [****] relates to the Manufacture or supply of Licensed Products in the Territory, to the extent that such contract is assignable. If any such agreement is not assignable, then Zai will cooperate with Blueprint in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Blueprint on terms substantially similar to those granted to Zai. [****] |
15.3.10 | Ongoing Clinical Trials. |
(a) | Transfer to Blueprint. If, as of the effective date of termination of this Agreement, Zai or its Affiliates are conducting any Clinical Trials for Licensed Products, then, at Blueprints election on a Clinical Trial-by-Clinical Trial basis, Zai will fully cooperate, and will ensure that its Affiliates fully cooperate, with Blueprint to transfer the conduct of such Clinical Trial to Blueprint or its designees. If Blueprint so elects, then Zai will continue to conduct such Clinical Trial [****] to enable such transfer to be completed without interruption of any such Clinical Trial (including the assignment of all related Regulatory Submissions and investigator and other agreements related to such Clinical Trials). [****] Zai will provide such knowledge transfer and other training to Blueprint or its designated Affiliate or Third Party as reasonably necessary for Blueprint or such designated Affiliate or Third Party to continue such Clinical Trial for the applicable Licensed Product. |
(b) | Wind-Down. If Blueprint does not elect to assume control over or have Zai continue to conduct any such Clinical Trials for a Licensed Product, then Zai will, in accordance with accepted pharmaceutical industry norms and ethical practices, wind-down the conduct of any such Clinical Trial in an orderly manner. Zai will be responsible for [****]. |
15.3.11 | Sublicense Survival. Upon termination of this Agreement, upon the request of any Sublicensee of Zai that was granted a sublicense in accordance with the terms of Section 2.2.1 (Right to Sublicense) and that is not then in breach of its sublicense agreement or the terms of this Agreement applicable to such Sublicensee, Blueprint will negotiate [****] with such Sublicensee with respect to the grant of a direct license to such Sublicensee, which license will not be broader in license scope, territory, or duration than such sublicense agreement granted by Zai to such Sublicensee and not more burdensome on Blueprint [****] and no less favorable to Blueprint than the financial terms of Article 10 (Payments) for the scope, territory, and duration of such sublicense and provided that such Sublicensee agrees to comply with all applicable terms of this Agreement. |
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15.3.12 | Return of Confidential Information. At the Disclosing Partys election, the Receiving Party will return (at Disclosing Partys expense) or destroy all tangible materials comprising, bearing, or containing any Confidential Information of the Disclosing Party relating to any Licensed Product that are in the Receiving Partys or its Affiliates or Sublicensees possession or control and provide written certification of such destruction (except to the extent any information is the Confidential Information of both Parties or to the extent that the Receiving Party has the continuing right to use the Confidential Information under this Agreement); provided that the Receiving Party may retain one copy of such Confidential Information for its legal archives. Notwithstanding anything to the contrary set forth in this Agreement, the Receiving Party will not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information. |
15.3.13 | Further Assistance. Zai will provide any other assistance or take any other actions, in each case, reasonably requested by Blueprint as necessary to give effect to this Section 15.3 (Effect of Termination), and will execute all documents as may be reasonably requested by Blueprint in order to give effect to this Section 15.3 (Effect of Termination). |
15.3.14 | [****] |
15.3.15 | Blueprint/Zai Combinations. Notwithstanding any provision to the contrary set forth in this Agreement, the effects of termination as it relates to any Blueprint/Zai Combination will be subject to the applicable terms agreed upon by the Parties for such Blueprint/Zai Combination under Section 5.8 (Proposed Blueprint/Zai Combinations). |
15.4 | Termination Press Releases. In the event of termination of this Agreement for any reason and subject to the terms of Section 11.7.1 (Press Release), the Parties will cooperate in good faith to coordinate public disclosure of such termination and the reasons therefor, and will not, except to the extent required by Applicable Law, disclose such information without the prior approval of the other Party. In any such disclosures, the Parties will observe the principles of accuracy, compliance with Applicable Law, and regulatory guidance documents, and reasonable sensitivity to potential negative investor reaction to such news. |
15.5 | Survival. Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing prior to such expiration or termination. Without limiting the foregoing, the following provisions of this Agreement will survive the expiration or termination of this Agreement: Article 1 (Definitions), Section 2.3.2 (Outside of Territory), Section 5.15 (Development Records), Section 5.17 (Data Exchange and Use) (to the extent set forth therein), Section 10.3.4 (Royalty Reports and Payments) (with respect to payments becoming due during the Term), Section 10.5 (Other Amounts Payable) (with respect to amounts becoming due during the Term), Section 10.11 (Financial Records and Audits) (with respect to payments becoming due during the Term), Section 11.1 (Duty of Confidence), Section 11.2 (Confidential Information), Section 11.3 (Authorized Disclosures), Section 11.4 (Tax Treatment), Section 11.5 (Publications), Section 11.8 (Attorney-Client Privilege), Section 12.8 (Time for Claims), Article 13 (Indemnification), Section 14.1 (Inventions), Section 14.2.3 (Joint Collaboration Technology), Section 14.2.4 (Cooperation), Section 14.9.3 (Ownership), Section 15.1 (Term), Section 15.3 (Effect of Termination), Section 15.4 (Termination Press Releases), Section 15.5 (Survival), Section 15.6 (Termination Not Sole Remedy), Article 16 (Dispute Resolution), and Article 17 (Miscellaneous). |
15.6 | Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything to the contrary set forth in this Agreement, all other remedies will remain available except as expressly set forth herein. |
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Article 16
DISPUTE RESOLUTION
16.1 | General. The Parties recognize that a dispute may arise relating to this Agreement or to the breach, enforcement, interpretation, or validity of this Agreement (a Dispute). Except as otherwise expressly set forth in this Agreement, any Dispute, including Disputes that may involve the Affiliates of any Party, will be resolved in accordance with this Article 16 (Dispute Resolution). |
16.2 | Negotiation; Escalation. The Parties will negotiate [****] to settle any Dispute under this Agreement, other than matters subject to resolution under Article 3 (Governance). Any Dispute relating to this Agreement or the breach, enforcement, interpretation, or validity of this Agreement will be referred to the Executive Officers for attempted resolution. If the Executive Officers are unable to resolve such Dispute within [****] after such Dispute is referred to them, then, upon the written request of either Party to the other Party, other than a Dispute relating to the scope, validity, enforceability, or infringement of any Patent Rights or trademark rights (which will be submitted for resolution to a court of competent jurisdiction in the country or region in which such Patent Rights or trademark rights were granted or arose), the Dispute will be subject to arbitration in accordance with Section 16.3 (Arbitration). |
16.3 | Arbitration. |
16.3.1 | Rules. In the event of a Dispute that cannot be resolved between the Parties or the Executive Officers as set forth in Section 16.2 (Negotiation; Escalation), either Party will be free to institute binding arbitration with respect to such dispute in accordance with this Section 16.3 (Arbitration) upon written notice to the other Party (an Arbitration Notice) and seek remedies as may be available. Any dispute unresolved under this Section 16.3 (Arbitration) will be settled by binding arbitration administered by the International Chamber of Commerce (ICC) (or any successor entity thereto) and in accordance with the ICC Rules of Arbitration then in effect, as modified in this Section 16.3 (Arbitration) (the Rules), except to the extent such rules are inconsistent with this Section 16.3 (Arbitration), in which case this Section 16.3 (Arbitration) will control. |
16.3.2 | Selection of Arbitrators. Upon receipt of an Arbitration Notice by a Party, the applicable dispute will be resolved by final and binding arbitration before a panel of three arbitrators (the Arbitrators), with each arbitrator having [****] of experience in the biotechnology or pharmaceutical industry and subject matter expertise with respect to the matter subject to arbitration [****]. Any Arbitrator chosen hereunder will have educational training and industry experience sufficient to demonstrate a reasonable level of scientific, financial, medical, and industry knowledge relevant to the particular dispute. Each Party will promptly select one Arbitrator, which selections will in no event be made later than [****] after receipt of the Arbitration Notice. The third Arbitrator will be chosen promptly by agreement of the Arbitrators chosen by each Party, but in no event later than [****] after the date on which the last of such Arbitrators was appointed. If the two Party-nominated Arbitrators cannot agree on the third Arbitrator, then the third Arbitrator will be appointed by ICC. |
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16.3.3 | Decisions. The Arbitrators decision and award will be made within [****]of the filing of the arbitration demand and the Arbitrators will agree to comply with this schedule before accepting appointment. However, this time limit may be extended by agreement of the Parties or by the Arbitrators. The Arbitrators will be authorized to award compensatory damages, but will not be authorized to reform, modify, or materially change this Agreement. The Arbitrators will, within [****] after the conclusion of the hearing, issue a written award and statement of decision describing the material facts and the grounds for the conclusions on which the award is based, including the calculation of any damages awarded. The proceedings and decisions of the arbitrator will be confidential, final, and binding on the Parties, and judgment upon the award of such arbitrator may be entered in any court having jurisdiction thereof. |
16.3.4 | Responsibility for Costs. Each Party will bear its own costs and expenses (including legal fees and expenses) relating to the arbitration proceeding, except that the fees of the Arbitrators and other related costs of the arbitration will be shared equally by the Parties, unless the Arbitrators determine that a Party has incurred unreasonable expenses due to vexatious or bad faith positions taken by the other Party, in which event the Arbitrators may make an award of all or any portion of such expenses (including legal fees and expenses) so incurred. |
16.3.5 | Limitations. The Arbitrators will be required to apply the internal laws of the State of New York as the governing law for this Agreement and to render the decision in writing and to comply with, and the award will be limited by, any express provisions of this Agreement relating to damages or the limitation thereof. To the extent punitive or other indirect damages are expressly limited under this Agreement, no Arbitrator will have the power to award punitive damages under this Agreement, regardless of whether any such damages are contained in a proposal. |
16.3.6 | Effectiveness of Agreement. Unless the Parties otherwise agree in writing, during the period of time during which any arbitration proceeding is pending under this Agreement, (a) the Parties will continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding; and (b) in the event that the subject of the Dispute relates to the exercise by a Party of a termination right hereunder, including in the case of a material breach of this Agreement, the effectiveness of such termination will be stayed until the conclusion of the proceedings under this Section 16.3 (Arbitration). |
16.3.7 | Confidential Proceedings. All arbitration proceedings and decisions of the Arbitrators under this Section 16.3 (Arbitration) will be Confidential Information of both Parties and subject to the terms of Article 11 (Confidentiality; Publication). The arbitration proceedings will take place in New York, New York, in the English language. |
16.3.8 | Equitable Relief. Nothing in this Section 16.3 (Arbitration) will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction, or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. |
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Article 17
MISCELLANEOUS
17.1 | Assignment. This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. Notwithstanding the foregoing, Blueprint may assign its rights to receive payments under this Agreement to one or more Persons without consent of Zai [****], and either Party may, without consent of the other Party, assign this Agreement and its rights and obligations hereunder (a) in whole or in part to an Affiliate of such Party, or (b) in whole to its successor-in-interest in connection with the sale of all or substantially all of its assets to which this Agreement relates, whether in a merger, acquisition, or similar transaction or series of related transactions; provided that in the case of the foregoing clause (a) or (b), the assigning Party provides written notice of such assignment to the non-assigning Party within [****] after the effective date of such assignment. Any attempted assignment of this Agreement not in accordance with this Section 17.1 (Assignment) will be null, void, and of no legal effect. Any permitted assignee will assume all assigned obligations of its assignor under this Agreement. The terms of this Agreement will be binding upon, and will inure to the benefit of, the Parties and their respected successors and permitted assigns. |
17.2 | Limitation of Liability. NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, OR DAMAGES FOR LOSS OF PROFIT IN CONNECTION WITH THIS AGREEMENT, IN EACH CASE, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 17.2 (LIMITATION OF LIABILITY) IS INTENDED TO OR WILL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 13.1 (BY ZAI ) OR SECTION 13.2 (BY BLUEPRINT), OR DAMAGES AVAILABLE TO A PARTY FOR THE OTHER PARTYS BREACH OF ITS OBLIGATIONS HEREUNDER RELATING TO Article 10 (CONFIDENTIALITY; PUBLICATION), MISAPPROPRIATION OR INFRINGEMENT OF INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY SUCH PARTY, OR A PARTYS BREACH OF ITS OBLIGATIONS UNDER SECTION 2.8 (EXCLUSIVITY). |
17.3 | Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality, and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provisions adversely affects the substantive rights of the Parties. The Parties will in such an instance use their best efforts to replace the invalid, illegal or unenforceable provisions with valid, legal, and enforceable provisions that, insofar as practical, implement the purposes of this Agreement. |
17.4 | Notices. All notices that are required or permitted hereunder will be in writing and sufficient if delivered by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, and in each case, addressed as follows (with a courtesy copy sent by email, which will not constitute notice): |
If to Blueprint:
Blueprint Medicines Corporation
45 Sidney Street
Cambridge MA 02139 USA
Attention: Chief Executive Officer
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with a copy to:
Blueprint Medicines Corporation
45 Sidney Street
Cambridge MA 02139 USA
Attention: Chief Legal Officer
Email: [****]
If to Zai:
Zai Lab Limited
4F, Bldg 1, Jinchuang Plaza
4560 Jinke Rd
Shanghai, China, 201210
Attention: [****]
With an electronic copy to [****]
with a copy to:
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94303
USA
Attention: [****]
with an electronic copy to [****]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice will be deemed to have been given: (a) [****] after dispatch if sent by internationally-recognized overnight courier; or (b) [****] after dispatch if sent by registered or certified mail, postage prepaid, return receipt requested.
17.5 | Governing Law. This Agreement, and all claims or causes of action (whether in contract, tort or statute) that may be based upon, arise out of or relate to this Agreement, or the negotiation, execution or performance of this Agreement or the breach thereof (including any claim or cause of action based upon, arising out of or related to any representation or warranty made in or in connection with this Agreement or as an inducement to enter into this Agreement), will be governed by, and enforced in accordance with, the internal laws of the State of New York, including its statutes of limitations without giving effect to the conflicts of law provisions thereunder. |
17.6 | Force Majeure. Both Parties will be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse will continue only so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. When the force majeure no longer exists, the affected Party must promptly resume performance. For purposes of this Agreement, force majeure will include conditions beyond the reasonable control of the non-performing Party, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, pandemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, failure of plant or machinery and act (or failure to act) of a government of any country or of any Governmental Authority (other than as a result of the non-performing Partys failure to comply with Applicable Law). The Parties agree the effects of the COVID-19 pandemic that is ongoing as of the Effective Date may be invoked as a force majeure for the purposes of this Agreement even though the pandemic is ongoing to the extent those effects are not reasonably foreseeable by the Parties as of the Effective Date. Notwithstanding the foregoing, a Party will not be excused from making undisputed payments that have accrued and are owed hereunder because of a force majeure affecting such Party. The affected Party will notify the other Party in writing of any force majeure circumstances that may affect its performance under this Agreement as soon as reasonably practical, will provide a good faith estimate of the period for which its failure or delay in performance under the Agreement is expected to continue based on currently available information, and will undertake reasonable efforts necessary to mitigate and overcome such force majeure circumstances and resume normal performance of its obligations hereunder as soon as reasonably practicable under the circumstances. If the force majeure circumstance continues, then the affected Party will update such notice to the other Party on a bi-weekly basis, or more frequently if requested by the other Party, to provide updated summaries of its mitigation efforts and its estimates of when normal performance under the Agreement will be able to resume. |
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17.7 | Entire Agreement; Amendments. This Agreement, together with the Schedules hereto, contains the entire understanding of the Parties with respect to the collaboration and the licenses granted hereunder. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the collaboration and the licenses granted hereunder, including the Confidentiality Agreement, are superseded by the terms of this Agreement. The Schedules to this Agreement are incorporated herein by reference and will be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of each Party. The foregoing will not be interpreted as a waiver of any remedies available to either Party or its Affiliates as a result of any breach, prior to the Effective Date, by the other Party or its Affiliates of such Partys or its Affiliates obligations pursuant to the Confidentiality Agreement. |
17.8 | Headings. The captions to the several Articles, Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections of this Agreement. |
17.9 | Independent Contractors. It is expressly agreed that Blueprint and Zai will be independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture or agency. Neither Blueprint nor Zai will have the authority to make any statements, representations, or commitments of any kind, or to take any action that is binding on the other Party without the prior written consent of the other Party. |
17.10 | Performance by Affiliates. Notwithstanding anything to the contrary set forth in this Agreement, ether Party will have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate. Each Party hereby guarantees the performance by its Affiliates of such Partys obligations under this Agreement and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. |
17.11 | Waiver. Any waiver of any provision of this Agreement will be effective only if in writing and signed by Blueprint and Zai. No express or implied waiver by a Party of any default under this Agreement will be a waiver of a future or subsequent default. The failure or delay of any Party in exercising any rights under this Agreement will not constitute a waiver of any such right, and any single or partial exercise of any particular right by any Party will not exhaust the same or constitute a waiver of any other right provided in this Agreement. |
17.12 | Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting Party will not apply. |
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17.13 | Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each will be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law. |
17.14 | Business Day Requirements. If any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a Business Day, then such notice or other action or omission will be deemed to be required to be taken on the next occurring Business Day. |
17.15 | Further Actions. Each Party agrees to execute, acknowledge, and deliver such further instruments, and to do all such other acts, as necessary or appropriate in order to carry out the purposes and intent of this Agreement. |
17.16 | Non-Solicitation of Employees. [****] each Party agrees that neither it nor any of its Affiliates will recruit, solicit, or induce any employee of the other Party [****] to terminate his or her employment with such other Party and become employed by or consult for such Party, whether or not such employee is a full-time employee of such other Party, and whether or not such employment is pursuant to a written agreement or is at-will. For purposes of the foregoing, recruit, solicit, or induce will not be deemed to mean (a) circumstances where an employee of a Party (i) initiates contact with the other Party or any of its Affiliates with regard to possible employment; or (ii) responds to general solicitations of employment not specifically targeted at employees of a Party or any of its Affiliates, including responses to general advertisements or postings, and (b) discussions, interviews, negotiations, offers, or acceptances of employment or similar activities that arise as a result of circumstances described in the foregoing clause (a). |
17.17 | Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words include, includes, and including will be deemed to be followed by the phrase without limitation, (c) the word will will be construed to have the same meaning and effect as the word shall, (d) any definition of or reference to any agreement, instrument, or other document herein will be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person will be construed to include the persons successors and assigns, (f) the words herein, hereof, and hereunder and words of similar import, will each be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Articles, Sections, Schedules, or Exhibits will be construed to refer to Articles, Sections, Schedules, or Exhibits of this Agreement, and references to this Agreement include all Schedules hereto, (h) the word notice means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder agree, consent, approve, or the like will require that such agreement, consent, or approval be specific and in writing, whether by written agreement, letter, approved minutes, or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term or will be interpreted in the inclusive sense commonly associated with the term and/or. |
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17.18 | Language; Translations. This Agreement is in the English language only, which language will be controlling in all respects, and all versions hereof in any other language will be for accommodation only and will not be binding upon the Parties. All communications and notices to be made or given by one Party to the other pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, will be in the English language. If there is a discrepancy between this Agreement and any non-English translation of this Agreement, this Agreement will prevail. Upon Blueprints request, Zai will provide to Blueprint any documentation in English already in Zais possession. For other material data, information, documents or materials, Zai will provide to Blueprint [****] in English upon Blueprints reasonable request. In addition, at Blueprints request, Zai will provide a full English translation of such material data, information, or materials [****]. Zai will be responsible[****] for the translation to Chinese of any documentation provided by Blueprint. [****] |
17.19 | Counterparts. This Agreement may be executed in counterparts, all of which taken together will be regarded as one and the same instrument. Counterparts may be delivered via electronic mail, including Adobe Portable Document Format (PDF) or any electronic signature complying with the U.S. Federal ESIGN Act of 2000, and any counterpart so delivered will be deemed to be original signatures, will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this Agreement. |
{Signature Page Follows}
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this License and Collaboration Agreement to be executed by their respective duly authorized representatives as of the Effective Date.
BLUEPRINT MEDICINES CORPORATION | ||
By: | /s/ Jeff Albers | |
Name: | Jeff Albers | |
Title: | CEO | |
ZAI LAB (SHANGHAI) CO., LTD | ||
By: | /s/ Samantha Du | |
Name: | Samantha Du | |
Title: | CEO |
[Signature Page to License and Collaboration Agreement]
Exhibit 10.24
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH [***]. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED.
LICENSE AGREEMENT
This License Agreement (this Agreement) is made as of November 8, 2021(the Effective Date), by and between Karuna Therapeutics, Inc., a corporation organized and existing under the laws of Delaware, located at 99 High Street, 26th Floor, Boston, Massachusetts, 02110, United States of America (Karuna), and Zai Lab (Shanghai) Co., Ltd, an exempted company organized and existing under the laws of P.R. of China, having a place of business at 4F, Bldg 1, Jinchuang Plaza, 4560 Jinke Rd, Shanghai, China, 201210 (Zai). Karuna and Zai are referred to in this Agreement individually as a Party and collectively as the Parties.
RECITALS
WHEREAS, Karuna is a biopharmaceutical company specializing in transformative medicines for the treatment of psychiatric and neurological conditions;
WHEREAS, Zai is a pharmaceutical company having experience in the development and commercialization of pharmaceutical products in the Licensed Territory (as defined below); and
WHEREAS, Karuna wishes to grant to Zai, and Zai wishes to be granted, an exclusive license to develop, manufacture and commercialize the Compound (as defined below) and Licensed Product (as defined below) in the Field (as defined below) in the Licensed Territory in accordance with the terms and conditions set forth below.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.1. Adverse Event means any unwanted or harmful medical occurrence in a patient or subject who is administered the Licensed Product, whether or not considered related to the Licensed Product, including any undesirable sign (including abnormal laboratory findings of clinical concern).
1.2. Affiliate means, with respect to a specified Person, any entity that directly or indirectly controls, is controlled by or is under common control with such Person, in each case, for so long as such control exists. As used in this Section 1.2, control (and, with correlative meanings, the terms controlled by and under common control with) means, in the case of a corporation, the ownership of more than fifty percent (50%) of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such entity or the power to appoint more than fifty percent (50%) of the members of the governing body of the entity or, where ownership of more than fifty percent (50%) of such securities or interest is prohibited by law, ownership of the maximum amount legally permitted.
1.3. Agreement has the meaning set forth in the preamble.
1
1.4. Alliance Manager has the meaning set forth in Section 3.2.
1.5. Anti-Corruption Laws has the meaning set forth in Section 10.4(a)(i).
1.6. [***].
1.7. Applicable Laws means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the relevant activities contemplated by this Agreement.
1.8. Authorized Regulatory Agent means a local entity (a) authorized by Karuna or any of its Affiliates, where Karuna, its Affiliate or its Third Party contractor research organization is the license holder of imported drug product, to exclusively (even as to Karuna and its Affiliates, but in accordance with terms and conditions hereunder) manage the work associated with obtaining any Regulatory Approval or product registration in the Licensed Territory, and (b) which possesses and maintains valid licenses or permits in the Licensed Territory if such licenses or permits are required for such local entity to engage in the relevant activities in the Licensed Territory.
1.9. Bankruptcy Code has the meaning set forth in Section 12.7.
1.10. Business Day means a day other than Saturday, Sunday or any day on which banks located in the State of Massachusetts or Shanghai, the PRC are authorized or obligated to close. Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.
1.11. Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31st, June 30th, September 30th and December 31st.
1.12. Calendar Year means each twelve (12) month period commencing on January 1st.
1.13. cGMP means all applicable current Good Manufacturing Practices including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent Applicable Laws in any relevant country or Region, each as may be amended and applicable from time to time.
1.14. Change of Control means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty (50%) of the total voting power of all of the then outstanding voting securities of such Party, (b) a merger, consolidation, recapitalization, or reorganization of such Party is consummated which results in shareholders or equity holders of such Party immediately prior to such transaction, no longer owning at least fifty (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction, or (c) there is a sale or transfer to a Third Party of all or substantially all of such Partys consolidated assets taken as a whole, through one or more related transactions.
1.15. Claims has the meaning set forth in Section 11.1.
1.16. Clinical Trial means any clinical testing of the Licensed Product in human subjects.
1.17. CMOs means Third Party contractor manufacture organizations.
2
[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED
1.18. Commercialization or Commercialize means all activities directed to marketing, distribution, promoting or selling of pharmaceutical products (including importing and exporting activities in connection therewith and securing pricing and reimbursement approvals, as necessary).
1.19. Commercialization Plan means the written plan for the Commercialization of the Licensed Product in the Licensed Territory, as updated in accordance with this Agreement.
1.20. Commercially Reasonable Efforts means with respect to a Party, the use of diligent, good faith efforts and resources, in an active and ongoing program, as normally used by such Party for a product discovered or identified internally or in-licensed from a Third Party that is important to such Partys overall strategy or objectives, which product is at a similar stage in its development or product life and is of similar market potential and intellectual property protection; provided, however, that in no event shall such efforts and resources be less than [***].
1.21. Competing Product means: [***].
1.22. Competing Product Notice has the meaning set forth in Section 2.9(c).
1.23. Compound means Karunas proprietary small molecule muscarinic modulator known as KarXT, which is a combination of xanomeline tartrate and trospium chloride, as developed by or on behalf of Karuna or its Affiliates as of the Effective Date and further described on Schedule 1.23, and [***].
1.24. Confidential Information means all confidential information of the Disclosing Party or its Affiliates, regardless of its form or medium as provided or made available to the Receiving Party or its Affiliates in connection with this Agreement; provided that, Confidential Information shall not include any information that the Receiving Party can show by competent written evidence: (a) was already known to the Receiving Party at the time it was disclosed to the Receiving Party by the Disclosing Party without an obligation of confidentiality and not through a prior disclosure by the Disclosing Party, (b) was or becomes generally known to the public through no act or omission of the Receiving Party in violation of the terms of this Agreement, (c) was lawfully received by the Receiving Party from a Third Party without restriction on its disclosure and without, to the reasonable knowledge of the Receiving Party, a breach by such Third Party of an obligation of confidentiality to the Disclosing Party, or (d) was independently developed by the Receiving Party without use of or reference to the Confidential Information of the Disclosing Party (provided that such exception shall not apply to any Product Invention). All Product Inventions shall be the Confidential Information of Karuna, and Karuna shall be the Disclosing Party and Zai shall be the Receiving Party with respect thereto. All Zai Inventions shall be the Confidential Information of Zai, and Zai shall be the Disclosing Party and Karuna shall be the Receiving Party with respect thereto. The terms of this Agreement that are not publicly disclosed through a press release or by filings to financial regulatory authorities in accordance with the terms of this Agreement shall be the Confidential Information of both Parties. All confidential information disclosed by a Party pursuant to the Confidentiality Agreement shall be deemed to be such Partys Confidential Information.
1.25. Confidentiality Agreement means that Confidential Disclosure Agreement, dated as of [***], by and between Karuna and Zai.
1.26. Control or Controlled means, with respect to any Know-How, Patents or other intellectual property rights, that a Party has the legal authority or right (whether by ownership, license or otherwise, after taking into account the provisions of this Agreement regarding ownership of Inventions, but without taking into account any license granted by one Party to the other Party pursuant to this Agreement) to grant a license, sublicense, access or right to use (as applicable) under such Know-How, Patents, or other intellectual property rights, on the terms and conditions set forth herein, in each case without (a) breaching the terms of any agreement with a Third Party or (b) incurring payments to a Third Party, except with respect to any Know-How and Patents in-licensed by Karuna pursuant to any Existing In-License Agreement or any New Karuna In-Licenses entered into in accordance with Section 2.12.
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1.27. CROs has the meaning set forth in Section 2.4.
1.28. CTA has the meaning set forth in Section 1.64.
1.29. Data means research, pharmacology, toxicological, preclinical, Clinical Trial, technical, chemical, formulation, Manufacturing, analytical and quality control, safety, and scientific data, including raw data, original records, investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases.
1.30. Develop or Development or Developing means preclinical and clinical drug development activities and other development activities with respect to a product, including test method development and stability testing, toxicology, formulation, process development, qualification and validation, quality assurance, quality control, clinical or preclinical trials, statistical analysis and report writing, the preparation and submission of INDs marketing authorization approvals or similar application, regulatory affairs with respect to the foregoing, and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval.
1.31. Development Data has the meaning set forth in Section 4.10(a).
1.32. Development Milestone Event has the meaning set forth in Section 8.2(a).
1.33. Development Milestone Payment has the meaning set forth in Section 8.2(a).
1.34. Development Plan has the meaning set forth in Section 4.1.
1.35. Development Target has the meaning set forth in Section 4.2(c).
1.36. Development Target Deadline has the meaning set forth in Section 4.2(c).
1.37. Disclosing Party has the meaning set forth in Section 9.1(a).
1.38. Dispute has the meaning set forth in Section 14.1.
1.39. Effective Date has the meaning set forth in the preamble in this Agreement.
1.40. Exclusive Negotiation Period has the meaning set forth in Section 2.9(c).
1.41. Executive Officers means, with respect to Karuna, [***] and, with respect to Zai, [***].
1.42. Existing In-License Agreement means the agreement set forth on Schedule 1.42.
1.43. Existing Patent Application means [***].
1.44. Expiration Date has the meaning set forth in Section 13.1(a).
1.45. Exploit or Exploitation means to Develop, Commercialize, register, Manufacture, have manufactured, use, have used, import, have imported, market, have marketed, distribute, have distributed, offer for sale, sell or have sold.
1.46. FDA means the U.S. Food and Drug Administration or its successor.
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1.47. Field means all uses in humans.
1.48. First Commercial Sale means, with respect to any particular country or Region, the first sale of the Licensed Product in such country or Region by any of Zai, an Affiliate, or a Sublicensee, or a distributor of any of them, after all Regulatory Approvals have been granted in such country or Region for the Licensed Product to be marketed and sold legally as a pharmaceutical in such country or Region.
1.49. Force Majeure Event has the meaning set forth in Section 15.2.
1.50. Fully Burdened Manufacturing Costs means the cost of Manufacturing the Licensed Product. Fully Burdened Manufacturing Costs shall be a standard cost per unit (calculated annually), comprised of the following elements calculated in accordance with GAAP or IFRS, as applicable: [***].
1.51. GAAP means the United States generally accepted accounting principles, consistently applied.
1.52. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Licensed Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws in the Region in the Licensed Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
1.53. Generic Launch Quarter has the meaning set forth in Section 8.4(c)(ii).
1.54. Global Development Plan has the meaning set forth in Section 4.4(a).
1.55. Global Study means a clinical study designed to obtain Regulatory Approvals for the Licensed Product in multiple jurisdictions through the conduct of a Clinical Trial in multiple medical institutions, countries, Regions, territories and conducted as part of one (1) unified Clinical Trial or separately but concurrently in accordance with a common Clinical Trial protocol.
1.56. GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Region in the Licensed Territory, each as may be amended and applicable from time to time.
1.57. Governmental Authority means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, Region, state or local authority or any political subdivision thereof, or any association of countries.
1.58. [***].
1.59. [***].
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1.60. GSP means all applicable Good Supply Practice standards, including, as applicable, as set forth in the then current good supply practice standards promulgated or endorsed by the FDA as defined in Good Supply Practice for Pharmaceutical Licensed Products or the equivalent Applicable Laws in the Region in the Licensed Territory, each as may be amended and applicable from time to time.
1.61. HGR Approval means any and all necessary record filings with, and approvals, licenses, and/or permits issued by, the Human Genetics Resources Administration of the PRC or any other Governmental Authorities in the PRC required for Development activities (including Clinical Trials) and data transfer and sharing under this Agreement with respect to the Exploitation of Licensed Product in the Field in the PRC.
1.62. ICC Rules has the meaning set forth in Section 14.4(a).
1.63. IFRS means international financial reporting standards, consistently applied.
1.64. IND means an investigational new drug application, or equivalent application such as a clinical trial applications filed with the applicable Regulatory Authority in a Region in the Licensed Territory (a CTA), which application is required to commence Clinical Trials in the Licensed Territory.
1.65. Indemnifying Party has the meaning set forth in Section 11.3.
1.66. Indemnitee has the meaning set forth in Section 11.3.
1.67. Indication means a separate and distinct disease or condition, or sign or symptom of a disease or medical condition in the Field. For clarity, different lines of treatment or the treatment of separate stages or forms or different population (e.g., adult vs pediatric) of the same disease or medical condition shall not constitute separate Indications.
1.68. Initial MAH has the meaning set forth in Section 5.1(e).
1.69. Invention means any and all inventions, discoveries and developments, whether or not patentable, which are created, conceived, developed or made in the course of performance of this Agreement, whether created, conceived, developed or made solely by, or on behalf of, Karuna, Zai, the Parties jointly or jointly with a Third Party, or any Affiliate of the same.
1.70. Joint Global Study has the meaning set forth in Section 4.4(b).
1.71. JSC has the meaning set forth in Section 3.1(a).
1.72. Karuna has the meaning set forth in the preamble of this Agreement.
1.73. Karuna Indemnitee(s) has the meaning set forth in Section 11.1.
1.74. Karuna Product Marks has the meaning set forth in Section 7.5.
1.75. Karuna Sponsored Regulatory and Commercial Activities has the meaning set forth in Section 5.1(e)(ii).
1.76. Karuna Sponsored Study has the meaning set forth in Section 5.1(d).
1.77. Know-How means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.
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1.78. Licensed Know-How means any and all Know-How Controlled by Karuna or its Affiliates as of the Effective Date or during the Term that is necessary for the Exploitation of the Compound or Licensed Product in the Field in the Licensed Territory, including all Product Inventions and all Development Data Controlled by Karuna and its Affiliates. Notwithstanding the foregoing, in the event a Change of Control of Karuna occurs after the Effective Date, Know-How Controlled by any Affiliate of Karuna that was not an Affiliate of Karuna immediately prior to such Change of Control transaction shall not be Licensed Know-How except to the extent such Know-How falls within the definition of Licensed Know-How in the immediately preceding sentence and (a) is also Controlled by Karuna or its Affiliate existing immediately prior to such transaction or (b) is generated or used by such Affiliate in the Exploitation of the Compound or Licensed Product after such transaction. Additionally, Licensed Know-How shall exclude (x) any Know-How relating to any other active ingredient or product in any combination regimen that includes the Licensed Product; or (y) any Know-How licensed to Karuna or its Affiliates pursuant to a Potential In-License entered into after the Effective Date unless such Potential In-License becomes a New Karuna In-License in accordance with Section 2.12.
1.79. Licensed Patents means the Patents in the Licensed Territory Controlled by Karuna or its Affiliates as of the Effective Date or during the Term that (a) claim or cover the Compound or the Licensed Product (including the composition of matter, method of use, formulation, manufacture, or method of packaging or labelling or use thereof), and (b) are necessary or reasonably useful for the Exploitation of the Compound or Licensed Product in the Field in the Licensed Territory, including all Patents that claim or cover Product Inventions. Schedule 1.79 contains a list of all Licensed Patents as of the Effective Date. Notwithstanding the foregoing, in the event a Change of Control of Karuna occurs after the Effective Date, Patents Controlled by any Affiliate of Karuna that was not an Affiliate of Karuna immediately prior to such Change of Control transaction shall not be Licensed Patents except to the extent any such Patent falls within the definition of Licensed Patents in the immediately preceding sentence and (i) is also Controlled by Karuna or its Affiliate existing immediately prior to such transaction or (ii) claims any Invention generated or used by such Affiliate in the Exploitation of the Licensed Product after such transaction. Additionally, Licensed Patents shall exclude (x) any Patent that claims or covers any other active ingredient or product in any combination regimen that includes the Licensed Product or (y) any Patents licensed to Karuna or its Affiliates pursuant to a Potential In-License entered into after the Effective Date unless such Potential In-License becomes a New Karuna In-License in accordance with Section 2.12.
1.80. Licensed Product means any product that contains the Compound in any forms, presentations, strengths, concentrations, delivery technology, dosages, formulation, package configuration and modalities.
1.81. Licensed Technology means the Licensed Know-How and Licensed Patents.
1.82. Licensed Territory means (a) Mainland China, (b) Macao Special Administration Region, (c) Taiwan and (d) subject to Section 2.5, Hong Kong Special Administration Region (each of (a)-(d), a Region).
1.83. Local Study means any Clinical Trial for the Licensed Product in the Field and which (a) Zai determines to conduct and is conducted by or on behalf of Zai in the Licensed Territory, and (b) does not include clinical sites in any country or jurisdiction outside the Licensed Territory.
1.84. Losses has the meaning set forth in Section 11.1.
1.85. Mainland China or PRC means the Peoples Republic of China, excluding Macau, Hong Kong, and Taiwan.
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1.86. Manufacture or Manufacturing or Manufactured means all operations involved in production, synthesis, manufacturing, processing, filling and finishing, quality assurance and quality control testing (including in-process, release and stability testing, if applicable), storage, releasing, packaging, labeling, shipping and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacturing and analytic development, product characterization, and stability testing.
1.87. Manufacturing Technology means any and all Licensed Know-How and other relevant information relating to the then-current process for the Manufacture of the Compound or Licensed Product.
1.88. Manufacturing Technology Transfer has the meaning set forth in Section 6.2.
1.89. Milestone Events means Development Milestone Events and Net Sales Milestone Events.
1.90. Milestone Payments means Development Milestone Payments and Net Sales Milestone Payments.
1.91. [***].
1.92. NDA has the meaning set forth in Section 1.115.
1.93. Net Sales means the gross amount invoiced by Zai, its Affiliates, or Sublicensees for sales or other transfers of Licensed Product to unrelated Third Parties in the Licensed Territory, in bona-fide arms length transactions, in each case less the following deductions: [***].
Such amounts shall be determined from the books and records of Zai, its Affiliates, or Sublicensees, maintained in accordance with generally accepted accounting principles (in accordance with GAAP or IFRS, as applicable) as consistently applied across its pharmaceutical products generally.
Net Sales on Licensed Product provided as part of a non-cash exchange or other than through an arms-length transaction shall mean [***].
Notwithstanding the foregoing, Net Sales shall not include [***].
In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no double counting of deductions).
The above deductions shall be the only deductions made in Net Sales and only to the extent such deductions are actually taken and documented as attributable to Licensed Product, and in all cases in a manner consistent with generally accepted accounting principles (in accordance with GAAP or IFRS, as applicable) consistently employed with respect to external reporting.
1.94. Net Sales Milestone Event has the meaning set forth in Section 8.3(a).
1.95. Net Sales Milestone Payment has the meaning set forth in Section 8.3(a).
1.96. New Karuna In-License has the meaning set forth in Section 2.12(c).
1.97. NMPA means the National Medical Licensed Product Administration in the PRC, including its subdivisions (including Center for Drug Evaluation), and local or provincial, and any successor agency(ies) or authority thereto having substantially the same function.
1.98. Party or Parties has the meaning set forth in the preamble to this Agreement.
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1.99. Patent Prosecution means the responsibility and authority for (a) preparing, filing and prosecuting applications (of all types) for any Patent (including any decision whether to file a further divisional application), (b) managing any interference, opposition, re-issue, reexamination, invalidation proceedings, revocation, nullification, or cancellation proceeding relating to the foregoing, (c) deciding to abandon Patent(s), (d) listing in regulatory publications (as applicable), (e) patent term extension, and (f) settling any interference, opposition, revocation, nullification or cancellation proceeding.
1.100. Patents means (a) all national, regional and international patents and patent applications, including any provisional patent application, (b) any patent application claiming priority from such patent application or provisional patent applications, including divisions, continuations, continuations-in-part, additions, (c) any patent that has issued or in the future issues from any of the foregoing patent applications, including any utility or design patent or certificate of invention, and (d) re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations and revalidations, and supplementary protection certificates and equivalents to any of the foregoing.
1.101. Person means any individual, sole proprietorship, corporation, joint venture, limited liability company, partnership, limited partnership, limited liability partnership, trust or any other private, public or governmental entity.
1.102. Pharmacovigilance Agreement has the meaning set forth in Section 5.8(a).
1.103. Post-Marketing Study means any study conducted by or for Zai in the Licensed Territory with respect to the Licensed Product after submission of a Regulatory Approval Application for the Licensed Product, whether initiated by a Party or at the request of an applicable Governmental Authority, to delineate additional information about a drugs risks, benefits, and optimal use, including safety surveillance studies, pharmacoeconomic studies, pharmacoepidemiology studies, studies relating to different dosing or schedules of administration, studies of the use of the drug in other patient populations or other stages of the disease, or studies of the use of the drug over a longer period of time, but, in any case, excluding any study that is necessary to be completed in order to obtain Regulatory Approval.
1.104. Potential In-License has the meaning set forth in Section 2.12(a).
1.105. Potential In-License Notice has the meaning set forth in Section 2.12(a).
1.106. Prime Rate means for any day a per annum rate of interest equal to the prime rate, as published in the Money Rates column of The Wall Street Journal, from time to time, or if for any reason such rate is no longer available, a rate equivalent to the base rate on corporate loans posted by at least [***] of the ten largest U.S. banks.
1.107. Product Infringement has the meaning set forth in Section 12.4(a)(i).
1.108. Product Invention means all Inventions other than any Zai Invention.
1.109. Product Marks has the meaning set forth in Section 7.5.
1.110. Public Official has the meaning set forth in Section 10.4(d).
1.111. Receiving Party has the meaning set forth in Section 9.1(a).
1.112. Records has the meaning set forth in Section 4.9.
1.113. Region has the meaning set forth in Section 1.82.
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1.114. Regulatory Approval means, with respect to the Licensed Product in a country, Region or jurisdiction, the approvals from the necessary Governmental Authority to import, market and sell the Licensed Product in such country, Region or jurisdiction (but excluding pricing approvals and reimbursement approvals).
1.115. Regulatory Approval Application means a New Drug Approval Application ( NDA as defined in the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), as amended from time to time) in the U.S., or any corresponding application for approval to import, market or sell a product in any country, Region or jurisdiction in the Licensed Territory (but excluding any application for pricing and reimbursement approvals).
1.116. Regulatory Authority means any applicable Governmental Authority responsible for granting Regulatory Approvals for Licensed Product, including the NMPA, and any corresponding national or regional regulatory authorities.
1.117. Regulatory Exclusivity means with respect to the Licensed Product in a country, Region or jurisdiction, any exclusive marketing rights or data exclusivity rights under Applicable Laws or conferred by any Regulatory Authority in accordance with Applicable Laws with respect to the Licensed Product in such country, Region or jurisdiction.
1.118. Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including INDs, Regulatory Approvals and Regulatory Approval Applications, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to the Licensed Product.
1.119. Remedial Action has the meaning set forth in Section 5.10.
1.120. Retained Rights has the meaning set forth in Section 2.6.
1.121. Royalty Payment has the meaning set forth in Section 8.4(a).
1.122. Royalty Term has the meaning set forth in Section 8.4(b).
1.123. Subcontractor has the meaning set forth in Section 2.4.
1.124. Sublicensee has the meaning set forth in Section 2.3(a)(iii). For clarity, a Third Party who was granted a sublicense by a Sublicensee under the right granted by Karuna hereunder, in whole or in part, shall also be deemed a Sublicensee.
1.125. Tax or Taxes means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon). For the avoidance of doubt, Taxes includes VAT.
1.126. Term has the meaning set forth in Section 13.1(a).
1.127. Third Party means an entity other than (a) Zai and its Affiliates or (b) Karuna and its Affiliates.
1.128. Third Party Product means any pharmaceutical product that (a) is sold or distributed in the Licensed Territory by a Third Party that is not an Affiliate or (sub)licensee (including a Sublicensee) of, or otherwise authorized by, Zai or its Affiliates under a marketing authorization granted by a Regulatory Authority in the Licensed Territory to such Third Party, and (b) contains [***].
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1.129. U.S. Dollars or $ means United States dollars, the lawful currency of the United States.
1.130. Upfront Payment has the meaning set forth in Section 8.1.
1.131. Valid Claim means (a) a claim of an issued and unexpired Patent included within the Licensed Patents (but excluding any Licensed Patent that claims Product Invention solely invented by Zai and assigned by Zai to Karuna pursuant to Section 12.2) that has not been (i) permanently revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or is not appealed within the time allowed for appeal, (ii) abandoned, disclaimed or rendered unenforceable through disclaimer or otherwise, or (iii) abandoned, or (b) a claim of any filed patent application included within the Licensed Patents (but excluding any Licensed Patent that claims Product Invention solely invented by Zai and assigned by Zai to Karuna pursuant to Section 12.2) which has not been held finally revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction and which (i) has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, (ii) has not been withdrawn or abandoned, or (iii) has not been lost through an interference proceeding, or (iv) has not been pending for more than [***] from its earliest priority date (after which time, such claim shall cease to be considered a Valid Claim until it subsequently issues and falls within the description in subclause (a)).
1.132. VAT means value-added taxes or other similar taxes.
1.133. Withholding VAT Taxes has the meaning set forth in Section 8.8(b).
1.134. Zai has the meaning set forth in the preamble of this Agreement.
1.135. Zai Implemented Patents has the meaning set forth in Section 12.3(b).
1.136. Zai Indemnitee(s) has the meaning set forth in Section 11.2.
1.137. Zai Inventions means all Inventions created, conceived, developed or made solely by or on behalf of Zai or its Affiliates under this Agreement other than those that relate specifically to [***]. For clarity, Zai Inventions do not include any Inventions that [***].
1.138. Zai Invention Patents means any Patents that claim or cover Zai Inventions.
1.139. Zai IP means all Zai Know-How and Zai Patents.
1.140. Zai Know-How all Know-How that is Controlled by Zai or its Affiliates as of the Effective Date or during the Term and is actually used by Zai or any of its Affiliates in its Exploitation of the Compound or Licensed Product in the Licensed Territory or in connection with the performance of Zais activities under this Agreement, including all Zai Inventions, but excluding any Know-How relating to any other active ingredient or product in any combination regimen that includes the Licensed Product.
1.141. Zai Patents means any Patents that are Controlled by Zai or its Affiliates as of the Effective Date or during the Term and claim or cover Zai Know-How, including Zai Invention Patents.
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ARTICLE 2
LICENSES
2.1. License Grant and Right of Reference to Zai.
(a) Subject to the terms and conditions of this Agreement, Karuna hereby grants to Zai an exclusive (subject to Section 2.6), royalty-bearing license, with the right to grant sublicenses through multiple tiers (solely in accordance with Section 2.3), under the Licensed Technology, to Exploit the Compound and Licensed Product in the Field in the Licensed Territory.
(b) Subject to the terms and conditions of this Agreement, Karuna hereby grants to Zai the right of reference to all Regulatory Submissions related to the Licensed Product in the Field submitted by or on behalf of Karuna or its Affiliates or (sub)licensees (and all data contained or referenced therein), with the right to grant further rights of reference to Sublicensees to the extent permitted pursuant to Section 2.3. Subject to the terms and conditions of this Agreement (including Section 4.4(b)), Zai and its Affiliates (and any Sublicensee to whom it may grant a further right of reference) may use such right of reference to Karunas Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining the Regulatory Approval of the Licensed Product in the Field in the Licensed Territory. Karuna shall provide to Zai, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the right of reference as contemplated under this Section 2.1(b).
2.2. License Grant and Right of Reference to Karuna.
(a) Subject to the terms and conditions of this Agreement, Zai hereby grants to Karuna an exclusive, fully paid-up and royalty free, and sublicenseable license under Zai IP to (i) exercise its Retained Rights and (ii) perform Karunas obligations under this Agreement, provided that, in each case ((i)-(ii)), such license shall be non-exclusive in the Licensed Territory.
(b) Subject to the terms and conditions of this Agreement, Zai hereby grants to Karuna the right of reference to all Regulatory Submissions related to the Licensed Product in the Field submitted by or on behalf of Zai or its Affiliates or Sublicensees (and all data contained or referenced therein), with the right to grant further rights of reference to Karunas Affiliates and (sub)licensees with respect to Licensed Product. Subject to the terms and conditions of this Agreement, Karuna and its Affiliates (and any licensee to whom it may grant a further right of reference) may use the right of reference to Zais Regulatory Submissions in the Field solely for the purpose of seeking, obtaining and maintaining the Regulatory Approval of the Licensed Product outside the Licensed Territory. Zai shall provide to Karuna, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the right of reference as contemplated under this Section 2.2(b).
2.3. Right to Sublicense.
(a) General. Subject to the remainder of this Section 2.3, Zai shall have the right to grant sublicenses under the license and rights granted in Section 2.1 to:
(i) its Affiliates without Karunas consent,
(ii) any Third Party Subcontractors engaged under Section 2.4, without Karunas consent, and
(iii) any Third Party (other than those described in subclause (ii)) as proposed in writing by Zai, upon Karunas prior written consent, not to be unreasonably withheld, conditioned, or delayed (each such permitted Third Party sublicensee in (ii) and (iii), a Sublicensee).
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(b) Zai shall ensure that each sublicense agreement between Zai and its Affiliate or Sublicensee is consistent with the terms of this Agreement, and specifically contains terms and conditions that: (i) require each such Affiliate or Sublicensee to protect and keep confidential any Confidential Information of the Parties, including in accordance with ARTICLE 9; (ii) provide Karuna with the right to audit (either by itself or through Zai or Zais designee) the books and records of each such Sublicensee in accordance with this Agreement (including pursuant to Sections 4.7, 5.9, 7.7, 8.6(b), 8.6(c), and 10.4(a)(iv)); (iii) do not impose any payment obligations or liability on Karuna; (iv) contain appropriate intellectual property assignment and license provisions to give effect of the IP ownership and license provisions in this Agreement. Zai shall, (A) with respect to any sublicense agreement with a Sublicensee other than those described in Section 2.3(a)(ii), prior to entering into any sublicense agreement, provide Karuna a copy of the draft sublicense agreement that is substantially final, [***], in order for Karuna to confirm compliance with the foregoing requirements and approve such sublicense agreement; and (B) within [***] after execution of each sublicense agreement, provide a copy of the complete executed agreement with each Affiliate or Sublicensee to Karuna, [***], provided that, Zai shall be permitted to redact commercially sensitive terms of any such agreement which terms are not necessary for Karuna to confirm Zais compliance with its obligations hereunder.
(c) Restrictions. Zai shall not grant a sublicense to any Affiliate or Third Party that has been debarred or disqualified by any Governmental Authority or is subject to any proceedings, sanctions or fines under any Anti-Corruption Law. Zai shall remain primarily responsible for all of its obligations under this Agreement that have been delegated or sublicensed to any Affiliate or Sublicensee, and Karuna shall have the right to proceed directly against Zai without any obligation to first proceed against such Affiliate or Sublicensee. Karuna may require that Zai enforce any provisions of any sublicense agreement between Zai (or its Affiliate) and a Sublicensee against the applicable Sublicensee. Without limiting the foregoing, Zai shall be liable for (i) its Affiliates Sublicensees conduct under this Agreement, and (ii) its Affiliates or Sublicensees breach of this Agreement which shall be deemed a breach of this Agreement as if Zai had itself conducted the action or inaction that contributed to the breach of this Agreement.
2.4. Subcontracting. Subject to the terms and conditions of this Agreement, Zai may engage Third Party contract research organizations (CROs), contract manufacturing organization, logistic service providers, sales contract sales, marketing providers or similar independent contractors (each, a Subcontractor) solely for purposes of, as applicable, conducting Development activities in accordance with the Development Plan, Manufacturing or Commercialization activities for the Licensed Product in the Field in the Licensed Territory, in each case, for or on behalf of Zai under this Agreement without Karunas prior written consent, provided that (a) any Subcontractor shall be bound by a written agreement that is consistent with the terms and conditions of this Agreement and shall include confidentiality and non-use of confidential information, and intellectual property assignment and license provisions, in each case, that are consistent with the applicable provisions of this Agreement, (b) Zai shall promptly notify Karuna identity of any such Subcontractor, including any audits Zai performs on such Subcontractor and provide Zai with a copy of any audit responses or audit reports [***]. Notwithstanding the foregoing, Zai shall remain primarily responsible for all of its obligations under this Agreement that have been delegated to or performed by a Subcontractor, and Karuna shall have the right to proceed directly against Zai without any obligation to first proceed against such Subcontractor. Karuna may require that Zai enforce any provisions of any agreement between Zai (or its Affiliate) and a Subcontractor against the applicable Subcontractor. Without limiting the foregoing, Zai shall be liable for (i) its Subcontractors conduct under this Agreement, and (ii) its Subcontractors breach of this Agreement which shall be deemed a breach of this Agreement as if Zai had itself conducted the action or inaction that contributed to the breach of this Agreement.
2.5. Hong Kong License. The Parties agree that the licenses and rights granted to Zai under Section 2.1 shall be extended to Hong Kong on the additional terms and conditions set forth on Schedule 2.5. Unless specifically stated otherwise on Schedule 2.5, all terms and conditions of this Agreement shall apply with respect to the Parties rights and obligations in connection with Exploitation of the Compound and Licensed Product in Hong Kong (mutatis mutandis).
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2.6. Karuna Retained Rights. Notwithstanding anything to the contrary in this Agreement, Karuna hereby expressly retains, on behalf of itself (and its Affiliates, other (sub)licensees, and designees) (a) all rights under the Licensed Technology to fulfill, either itself, its Affiliates or through subcontractors, Karunas obligations under this Agreement, (b) the exclusive rights to Exploit the Compound and Licensed Product outside the Licensed Territory or outside the Field anywhere in the world (but without the right to Commercialize the Compound or the Licensed Product in the Licensed Territory during the Term, except with respect to any right or obligation of Karuna as the Initial MAH in accordance with the terms of this Agreement or otherwise required by Applicable Laws), (c) subject to and in accordance with Section 4.4, the non-exclusive rights under the Licensed Technology to conduct the Global Studies, (d) the non-exclusive rights to Manufacture or have Manufactured the Compound or Licensed Product in the Licensed Territory, solely to support (i) the Exploitation of the Compound and Licensed Product outside of the Licensed Territory, and (ii) the Exploitation of the Licensed Product in the Licensed Territory (including through the conduct of Global Studies by Karuna pursuant to Section 4.4), and (e) the right to exercise its rights and perform obligations as the CTA holder for the Karuna Sponsored Studies and the Initial MAH, as set forth in this Agreement or otherwise required by Applicable Laws (collectively (a)-(e), the Retained Rights). Zai acknowledges and agrees that the Retained Rights include the right for Karuna to grant licenses under clauses (a) through (e) of the Retained Rights to its Affiliates and Third Parties.
2.7. No Other Rights. Except for the licenses and rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by a Party to the other Party. All rights with respect to Know-How, Patents or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof. Further, the licenses and other rights granted to Zai herein are subject to the rights retained by the counterparty to each Existing In-License Agreement and New Karuna In-License, as applicable.
2.8. Covenant Not to Exceed the Scope of the License. Each Party shall not, and shall not permit any of its Affiliates or sublicensees to, practice any Patent or Know-How licensed to it by the other Party outside the scope of the licenses granted to it under this Agreement.
2.9. Exclusivity.
(a) Subject to the remainder of this Section 2.9, unless otherwise agreed by the Parties in writing:
(i) During the period commencing on the Effective Date and ending on [***], neither Party shall, for itself, or with, through or for its Affiliates or any Third Party (including the grant of any license, option or other right to any Third Party), directly or indirectly, seek Regulatory Approval of, or Commercialize any [***] anywhere in the Licensed Territory, other than the Compound or Licensed Product as expressly permitted under this Agreement.
(ii) During the Term, Zai shall not, for itself, or with, through or for its Affiliates or any Third Party (including the grant of any license, option or other right to any Third Party), directly or indirectly, engage in or conduct any clinical Development, seek Regulatory Approval of, or Commercialize any [***] anywhere in the Licensed Territory, other than the Compound or Licensed Product as expressly permitted under this Agreement.
(b) Notwithstanding Section 2.9(a), in the event that a Third Party becomes an Affiliate of a Party after the Effective Date through merger, acquisition, consolidation or other similar transaction, and such Third Party, as of the closing date of such transaction, is engaged in the Exploitation of [***] in the Licensed Territory in a manner that is not permitted under Section 2.9(a), then:
(i) if such transaction results in a Change of Control of such Party, then such new Affiliate shall have the right to continue the Exploitation of [***] in the Licensed Territory and such continuation shall not constitute a breach of such Partys exclusivity obligations set forth above; provided that such Party and its new Affiliate, for the duration of the applicable exclusivity obligation, [***]; and
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(ii) if such transaction does not result in a Change of Control of such Party, then such Party and its new Affiliate shall have [***] from the closing date of such transaction to wind down or divest (including exclusively out-license with no further active Exploitation) such [***], and its new Affiliates Exploitation of such [***] during such [***] period shall not deemed a breach of such Partys exclusivity obligations set forth above; provided that, during such [***], such Party and its new Affiliate [***].
(c) During the Term, if Karuna or any of its Affiliates directly or indirectly, engages in or conducts clinical Development of [***] and desires to, either by itself, or through its Affiliates or any Third Party (including the grant of any license, option or other right to any Third Party), engage in any Commercialization of [***] anywhere in the Licensed Territory, it shall promptly notify Zai in writing of such intention, together with a reasonably detailed summary of any material Development results of [***] (the Competing Product Notice). Zai may, within [***] following receipt of the Competing Product Notice, provide a written notice to Karuna and elect to exclusively negotiate with Karuna a license for the Exploitation of [***] in the Licensed Territory. Thereafter, the Parties shall negotiate in good faith for a period of [***] (the Exclusive Negotiation Period). If Zai fails to provide such notice, or, despite exercising good faith efforts, the Parties cannot reach an agreement with respect to such license for [***] in the Licensed Territory within the Exclusive Negotiation Period, then Karuna shall, have the right, either by itself or with, through or for its Affiliates or any Third Party, to Exploit [***] in the Licensed Territory, without any obligation to Zai, provided that, (i) if despite good faith negotiations, the Parties cannot agree with respect to such license for [***], Karuna agrees not to [***]; and (ii) if Karuna does not enter an agreement with any Third Party with respect to the grant of such rights [***], then Zais first right of negotiation under this Section 2.9(c) with respect to [***] shall again become effective and applicable;
(d) The obligations of Karuna set forth in Section 2.9(c) (x) shall terminate if Karuna undergoes a Change of Control after the Effective Date; except that, upon Change of Control of Karuna during the Term, such obligations set forth in Section 2.9(c) shall continue to apply to [***] prior to such Change of Control by Karuna or any of its Affiliates existing prior to such Change of Control; and (y) shall not apply if a Third Party becomes an Affiliate of Karuna after the Effective Date through merger, acquisition, consolidation or other similar transaction, and such transaction does not result in a Change of Control of Karuna, with respect to [***] Exploited by such new Affiliate or any of its Affiliates with a Third Party as of the closing date of such transaction.
2.10. Access to Licensed Know-How. Within [***] following the Effective Date, Karuna shall provide Zai access to all Licensed Know-How as of the Effective Date, which access shall occur in a manner and following a reasonable schedule mutually agreed by the Parties. During the Term, Karuna shall provide or make available to Zai additional Licensed Know-How, to the extent that such Licensed Know-How comes to Karunas attention (or is reasonably requested by Zai) and has not previously been provided or made available to Zai, to the extent necessary or reasonably useful for Zai to exercise its rights or perform its obligations under this Agreement. In connection with transfer of the Licensed Know-How, Karuna shall also provide Zai with reasonable technical assistance in order for Zai to use and apply the Licensed Know-How in the Exploitation of the Compound and Licensed Product, including reasonable access to its technical personnel involved in the Exploitation of the Compound and Licensed Product. Zai shall reimburse Karuna for the cost incurred by Karuna to provide such technical assistance, [***].
2.11. Existing In-License Agreements. All licenses and other rights granted to Zai under this Agreement (including any sublicense rights) are subject to the rights and obligations of Karuna under the Existing In-License Agreements. Zai acknowledges and agrees that it will comply with all of the obligations under the Existing In-License Agreements to the extent applicable to Zai as a sublicensee thereunder that are set forth on Schedule 2.11 (the Existing In-License Agreement Terms), which shall be incorporated in this Agreement by reference. Karuna shall be solely responsible for the payment of any royalty, milestone and other payments due to Third Parties under any Existing In-License Agreement on account of Zais, its Affiliates and Sublicensees Exploitation of the Compound and Licensed Product in the Field in the Licensed Territory in accordance with this Agreement and the Existing In-License Agreement Terms.
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2.12. New Karuna In-Licenses.
(a) If, during the Term, Karuna enters into any agreement with a Third Party pursuant to which it obtains a licensable or sublicensable (in accordance with the terms of this Agreement) right or license from such Third Party to any Patents or Know-How that would, but for the provisions of this Section 2.12 constitute Licensed Technology (such agreement, a Potential In-License), then Karuna shall promptly notify Zai thereof in writing, including by providing a summary description of: (i) such Patents or Know-How under such Potential In-License; (ii) all payments that Karuna would be obligated to pay to such Third Party in connection with the grant, maintenance, or exercise of a license or sublicense to or by Zai under such Patents or Know-How; and (iii) all obligations with which Zai would be required to comply as a licensee or sublicensee under such Potential In-License (such notice, a Potential In-License Notice).
(b) If, within [***] after the receipt of a Potential In-License Notice, Zai provides Karuna with written notice indicating interest in obtaining a license or sublicense under such Patents or Know-How, then Karuna shall promptly provide Zai with a copy of such Potential In-License, which copy may be redacted to exclude terms not relevant to the rights or obligations that Zai would receive or assume if it were to exercise its rights under this Section 2.12 to include such Patents or Know-How as Licensed Technology.
(c) If, within [***] after receipt of such copy referenced in Section 2.12(b), Zai provides Karuna with written notice in which: (i) Zai consents to including the applicable Patents or Know-How in the Licensed Technology; and (ii) Zai agrees to (A) make all payments when due under such Potential In-License to the extent arising out of the grant, maintenance, or exercise of a license or sublicense to or by Zai under such Patents or Know-How and (B) comply with all obligations under such Potential In-License as required to comply as a licensee or sublicensee under such Potential In-License, then (x) such Potential In-License shall be deemed a New Karuna In-License thereafter, (y) any such Patents or Know-How, to the extent otherwise falling within the definition of Licensed Technology, shall be added to Licensed Technology and licensed or sublicensed to Zai under this Agreement, and (z) Zai shall be obligated to make any payments referenced in the foregoing sub-clause (ii)(A). If Zai does not provide such notices required by this Section 2.12, such Patents and Know-How will be excluded from the Licensed Technology pursuant to this Agreement and such Potential In-License will not become a New Karuna In-License.
ARTICLE 3
GOVERNANCE
3.1. Joint Steering Committee.
(a) Formation. Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the JSC) to cooperate, coordinate, integrate and monitor the Development and Commercialization of the Compound and Licensed Product in the Field in the Licensed Territory under this Agreement. Each Party shall appoint [***] (or such other equal number of representatives as agreed by the Parties in writing) to the JSC, each of whom shall be an officer or employee of the applicable Party having sufficient seniority within such Party to make decisions arising within the scope of the JSCs responsibilities. Each Party may replace its JSC representatives upon written notice to the other Party. Upon the JSCs establishment, a representative from Zai shall act as the chairperson of the JSC. Once a year, the role of chairperson shall rotate between the Parties. The chairperson shall not have any greater authority than any other representative of the JSC.
(b) Role. The JSC shall [***].
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(c) Limitation of Authority. The JSC shall only have the powers expressly assigned to it in this ARTICLE 3 and elsewhere in this Agreement and shall not have the authority to: (i) modify or amend the terms and conditions of this Agreement; (ii) waive either Partys compliance with the terms and conditions of this Agreement; (iii) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement; (iv) make any decisions related to, or determine, approve or oversee the initiation, suspension, cessation, conduct, strategy, implementation of or other matters related to, any Global Study; or (v) impose any other obligations on either Party without the prior written consent of such Party.
(d) Meetings. The JSC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than [***]. Each Party may call additional ad hoc JSC meetings as the needs arise with reasonable advance notice to the other Party. Meetings of the JSC may be held in person, or by audio or video teleconference, unless otherwise agreed by the Parties. In-person JSC meetings shall be held at locations mutually agreed by the Parties. Each Party shall be responsible for such Partys expenses of participating in the JSC meetings. No action taken at any JSC meeting shall be effective unless at least [***] of each Party are participating in such JSC meeting. The Alliance Manager appointed by Zai as set forth in Section 3.2 herein shall prepare the minutes for all JSC meetings, which such minutes shall be approved by the JSC at the subsequent meeting.
(e) Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants relevant to items on the issued agenda, in addition to its representatives, to attend the JSC meetings in a non-voting capacity; provided that if either Party intends to have any Third Party (including any consultant) attend such a meeting, such Party shall provide prior written notice to the other Party, and such Party shall also ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement.
(f) Decision-Making. [***]. If after reasonable discussion and good faith consideration of each Partys view on a particular matter before the JSC, the JSC cannot reach a decision as to such matter within [***] after such matter was brought to the JSC for resolution, such matter shall be referred by a notice sent pursuant to Section 15.5 by the JSC to the Executive Officers of both Parties for resolution. If the Executive Officers cannot resolve such matter within [***] after such matter has been referred to them, then such matter shall be resolved as follows:
(i) Except as otherwise provided in Section 3.1(f)(iii), Zai shall have final decision making authority over such matter to the extent such matter primarily relates to [***]. Notwithstanding the foregoing, if Karuna reasonably believes that any decision made by Zai pursuant to this Section 3.1(f)(i) would be reasonably expected to [***], Karuna shall have the final decision-making authority over such matter. Notwithstanding the foregoing, Zai shall have the final decision-making authority regarding [***].
(ii) Karuna shall have the final decision-making authority over all matters relating to [***], provided that Karuna shall not use its final decision-making authority in a manner that would [***].
(iii) Notwithstanding anything to the contrary, the following matters shall require the Parties mutual agreement, with neither Party having the final decision-making authority with respect thereto: [***].
(g) Exchange of Information. The Parties shall cooperate to exchange information through the JSC and otherwise as reasonably requested by the other Party with respect to Development, Manufacture, Commercialization and medical affairs activities conducted by each Party and their Affiliates, in the case of Zai its Sublicensees, and in the case of Karuna, its (sub)licensees of rights to the Compound or Licensed Product outside the Licensed Territory. Such exchange shall include summaries of information relating to material Development activities of each Party, including all Clinical Trials of the Licensed Product, IND and Regulatory Approval Application filings for all Indications for the Licensed Product. For Clinical Trials of the Licensed Product that may be used to support Regulatory Approval for the Licensed Product in the other Partys territory (including Global Studies), such exchange shall also include all data, results and analyses as reasonably requested by a Party, and the other Party shall have the right to use such data and results for the purpose of obtaining and maintaining Regulatory Approval for the Licensed Product in its territory, subject to Section 4.4(d).
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3.2. Alliance Managers. Within [***] following the Effective Date, each Party shall appoint (and notify the other Party of the identity of) a representative having the appropriate qualifications (including a general understanding of pharmaceutical Development and Commercialization issues) to act as its alliance manager with respect to this Agreement (the Alliance Manager). The Alliance Managers shall serve as the primary contact points between the Parties regarding the activities in the Licensed Territory contemplated under this Agreement. The Alliance Managers shall (a) facilitate the flow of information; (b) otherwise promote communication, coordination and collaboration between the Parties by providing single point communication for seeking consensus both internally within each Partys respective organization, including facilitating review of external corporate communications, and raising cross-Party or cross-functional disputes in a timely manner; and (c) manage the JSC meetings by (i) calling meetings of the JSC; (ii) preparing and issuing minutes of each such meeting within [***] thereafter; and (iii) preparing and circulating an agenda for the upcoming meeting, in each case at the direction of and in consultation with the then-current chairperson, provided that the Alliance Manager of each Party shall not have the authority to vote on behalf of such Party with respect to any matters within the authority of the JSC. Each Party may replace its Alliance Manager by written notice to the other Party.
ARTICLE 4
DEVELOPMENT
4.1. Development Plan. The Parties shall undertake the Development of the Licensed Product in a collaborative and efficient manner in accordance with this ARTICLE 4. The Development and Manufacturing of the Compound and Licensed Product relating to the Licensed Territory under this Agreement shall be governed by a written development plan (the Development Plan), as revised from time to time in accordance with this Section 4.1. The Development Plan shall include [***]. The Development Plan shall contain in reasonable detail the major Development activities and the projected timelines for conducting such activities, including activities designed to achieve Regulatory Approvals for the Licensed Product in the Licensed Territory. An initial Development Plan is attached hereto as Schedule 4.1. From time to time, and subject to Zais diligence obligations set forth in Section 4.2(c) (as may be modified by Section 4.2(d)), Zai may propose certain necessary updates or amendments to the Development Plan in consultation with Karuna and submit such proposed updated or amended plan to the JSC for review, discussion and approval. In accordance with Section 3.1(b), the JSC shall review, discuss and approve any updates or amendments to the Development Plan. For clarity, the Parties acknowledge and agree that Zai will not undertake any activities relating to [***].
4.2. Responsibilities; Diligence.
(a) General. During the Term, subject to the JSCs oversight, and rights of Karuna as the CTA holder for the Karuna Sponsored Studies and the Initial MAH, as set forth in this Agreement or otherwise required by Applicable Laws, Zai shall have the primary responsibility for the Development of the Licensed Product in the Field in the Licensed Territory, in accordance with the Development Plan, at Zais sole cost and expense subject to Section 4.4(b). Zai shall perform such obligations under the Development Plan in a professional and scientific manner, and in compliance with the requirements of Applicable Laws, GCP and cGMP. Changes in the scope or direction of the Development work under this Agreement that would be a material deviation from the Development Plan must be approved by the JSC as set forth in Section 3.1(b); provided that any change with respect to Joint Global Studies shall be consistent with the Joint Global Studies as set forth in the Global Development Plan.
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(b) Diligence. During the Term, Zai, by itself or through its Affiliates and Sublicensees, shall use Commercially Reasonable Efforts to Develop the Licensed Product in the Field in each Region in the Licensed Territory in accordance with the Development Plan.
(c) Development Targets. Without limiting the foregoing, Zai shall achieve the following Development milestones with respect to the Development of the Licensed Product in the PRC (each, a Development Target and the associated deadline, Development Target Deadline). [***].
(d) Extension for Delay. Upon the JSCs approval (not to be unreasonably withheld, conditioned or delayed), the Development Target Deadline for each Development Target above may be extended by the duration of any delays that are encountered during the course of Development and caused by [***]. Notwithstanding the foregoing, if Zai fails to meet any Development Target Deadline that is due, the JSC shall be deemed to have approved an extension to the extent Zai has presented reasonable written documentary evidence demonstrating that, at the time such Development Target Deadline is due: [***].
(e) Failure to Meet Development Target Deadlines. and [***] Karuna shall have the right to terminate this Agreement as provided in Section 13.3, [***] subject to Zais right to dispute the applicability of.
4.3. Local Study.
(a) Subject to rights of Karuna as the CTA holder of the Karuna Sponsored Studies and Initial MAH, as set forth in this Agreement or otherwise required by Applicable Laws, Zai shall be solely responsible for performing any Local Study at its sole cost (including handling relevant Regulatory Submissions for any Local Studies in the Licensed Territory at its own cost, as applicable, in accordance with ARTICLE 5), as set forth in the Development Plan; provided that [***]. Each Local Study conducted in the Licensed Territory shall be conducted in accordance with the Development Plan, including the study protocol set forth therein and approved by any relevant Regulatory Authority, and Applicable Laws in the Licensed Territory.
(b) Without limiting the foregoing, for each Karuna Sponsored Study, [***].
(c) [***].
4.4. Global Study.
(a) General. Karuna may initiate, suspend, or cease a Global Study for the Licensed Product for any Indication. As between the Parties, Karuna shall be responsible for any Global Study of the Licensed Product, subject to this Section 4.4, with respect to participation by Zai in Joint Global Studies. Karuna shall present to the JSC a global development plan for any Global Study that includes clinical sites for Clinical Trials for the Licensed Product in the Licensed Territory (the Global Development Plan). The JSC shall discuss such Global Development Plan for Zais potential participation in such Global Study in the Licensed Territory.
(b) Zai may participate in a Global Study presented by Karuna in a Global Development Plan based upon mutual agreement of the Parties (such agreed Global Study, a Joint Global Study). Unless otherwise agreed between the Parties, Zai shall be responsible for all activities associated with conducting each Joint Global Study in the Licensed Territory set forth in the applicable Global Development Plan, and any additional or modified activities for such Joint Global Study in the Licensed Territory so agreed between the Parties shall be included in an amendment to the Global Development Plan. Zai shall recruit, enroll, treat, and provide follow-up in a timely manner with respect to an agreed number or percentage of the total number of patients to be treated under the protocol set forth in the Regulatory Submission to the FDA and NMPA for the Joint Global Study and in accordance with the Global Development Plan (as may be amended pursuant to the preceding sentence), provided that if the percentage of the total number of patients enrolled in the Licensed Territory exceeds [***] of the total number of patients enrolled in a Joint Global Study, Karuna will be responsible for the costs of such patients enrolled in the Licensed Territory above such [***].
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(c) Zai, itself or with or through any other of its Affiliates or Sublicensees, shall, in accordance with Section 5.1, be the Authorized Regulatory Agent of each Joint Global Study in the Licensed Territory. For any Joint Global Study, Zai shall be responsible for [***], and Karuna shall be responsible for [***].
(d) If Zai elects not to participate in any Global Study presented by Karuna by notifying Karuna in writing of such election not to participate (or by failing to notify Karuna in writing of its election to participate) within [***] after the date of Karunas presentation of such Global Study to the JSC, Karuna may conduct such Global Study in the Licensed Territory [***] but in conducting such Global Study, the Parties shall coordinate the Parties Development activities for the Licensed Product in the Licensed Territory, provided that Zai shall not have access, or any right of reference to, any data (except for safety data) generated from such Global Study, and any Know-How (except for safety data) or Patents resulting from such Global Study shall be excluded from Licensed Technology unless Zai notifies Karuna in writing of Zais intent to have access and right of reference to such data, and to include any such Know-How or Patents in Licensed Technology, in which case, Zai shall pay to Karuna [***].
4.5. Post-Marketing Studies. If the Regulatory Authority requires that a Post-Marketing Study for the Licensed Product be conducted in the Licensed Territory, or if the Parties mutually agree that a Post-Marketing Study for the Licensed Product in the Licensed Territory is necessary (such agreement not to be unreasonably withheld, conditioned, or delayed), Zai shall be responsible for conducting such Post-Marketing Study for the Licensed Product in the Licensed Territory, including [***].
4.6. Development Reports. The status, progress and results of Zais Development activities under this Agreement shall be discussed at meetings of the JSC. At least [***] before each regularly scheduled JSC meeting, Zai shall provide the JSC with a written report in English summarizing its Licensed Product Development activities and the results thereof, covering subject matter at a level of detail reasonably requested by Karuna and sufficient to enable Karuna to determine such Zais compliance with its obligations pursuant to Section 4.1 to Section 4.4. In addition, Zai shall make available to Karuna such additional information about its Development activities with Licensed Product as may be reasonably requested by Karuna from time to time. All updates and reports provided by Zai pursuant to this Section 4.6 shall be the Confidential Information of Zai.
4.7. Clinical Trials Compliance and Registration. Each Party shall conduct all Clinical Trials of the Licensed Product in the Licensed Territory in compliance with all Applicable Laws, including GCP and regulations promulgated by the NMPA. Zai shall be responsible for registering in the appropriate clinical trial registry and posting the results of all studies for the Licensed Product conducted under an IND filed by or on behalf of Zai for the Licensed Product in the Licensed Territory as required by Applicable Law. Zai further agrees to allow Karuna to post the clinical trial results of Zais Clinical Trials for the Licensed Product as required by Applicable Law.
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4.8. Conduct of Audits. Upon [***] prior written notification by Karuna but no more frequent than [***] (except in the event that Karuna has reasonable cause), and based on an audit scope agreed upon by the Parties, Karuna or its representatives may conduct an audit of Zai, its Affiliates, or any Sublicensees or Subcontractors, and all Clinical Trial sites engaged by Zai or its Affiliates, Sublicensees or Subcontractors to perform Zais obligations under any Development Plan, in each case, to ensure that the applicable Clinical Trials are conducted in compliance with the Development Plan, GCP, and Applicable Laws; provided that in the event any such audit of Zais Subcontractors or Clinical Trial sites engaged by Zai or its Affiliates or Sublicensees, in each case, requires Zais assistance, Zai shall provide Karuna or its representatives with such assistance [***], to the extent reasonable, including providing personnel of Zai to be present for such audit and producing any documents or authorizations allowing Karuna or its representatives to conduct such audit, to the extent reasonable. No later than [***] after the completion of such audit, Karuna shall provide Zai with a written summary of Karunas findings of any deficiencies or other areas of remediation that Karuna identifies during any such audit. Zai shall use Commercially Reasonable Efforts to respond or remediate any such deficiencies within [***] following Karunas receipt of such report. Without limiting the foregoing, Zai shall have the right to be present at any such audit conducted by Karuna pursuant to this Section 4.8 of any Sublicensees, Subcontractors, or Clinical Trial sites.
4.9. Records. In conformity with Applicable Law, standard pharmaceutical industry practices and the terms and conditions of this Agreement, each Party shall prepare and maintain, or shall cause to be prepared and maintained, complete and accurate written records, accounts, notes, reports and data (including Development Data) with respect to activities conducted concerning the Licensed Product (Records) in the Licensed Territory; provided, that in no instance shall such Records be maintained for less than the latest of (a) [***] following the end of the Calendar Year to which the records pertain, (b) requirements under Applicable Law or (c) such Partys standard operating practice. Upon a Partys written request and to the extent required by Applicable Law or applicable Regulatory Authorities in the Licensed Territory, the other Party shall make available to the requesting Party electronic copies (unless otherwise required by Applicable Law) of the aforesaid required Records to the requesting Party throughout the Term and thereafter as long as such other Party Controls such Records, which shall be at minimum for the time period set forth above.
4.10. Ownership, Disclosure and Use of Development Data.
(a) Except as otherwise provided by Section 12.1 with respect to Inventions, during the Term, any and all Data and other results generated by a Party, its Affiliate or its respective licensees, sublicensees, collaboration partners, contractors, subcontractors (including Subcontractors) concerning the Licensed Product, including relevant laboratory notebook information, screening data, regulatory data (including all data and results created for or provided to any Regulatory Authority) and data from all pre-clinical studies (including toxicology studies) and Clinical Trials of the Licensed Product (including all data and results created for or provided to any Investigator Review Board or principal investigator of any pre-clinical study or Clinical Trial) (collectively, the Development Data), shall, as between Zai and Karuna, (i) be owned solely and exclusively by Karuna if [***], (ii) be jointly owned by Karuna and Zai if [***]. Each Party shall require that all of its Affiliates, Sublicensees and subcontractors (including Subcontractors) assign any of such Affiliates, Sublicensees and subcontractors(including Subcontractors) right, title and interest in and to such Development Data to such Party in order to comply with this provision.
(b) All material Development Data in Control of Karuna or its Affiliates and existing as of the Effective Date that is necessary for the Development and Commercialization of the Licensed Product in the Licensed Territory shall be made available to Zai (or its designee) as promptly as practicable, in any event within [***] after the Effective Date. Any additional material Development Data generated by or on behalf of a Party or its Affiliates and in its Control after the Effective Date and during the Term of this Agreement that is necessary for the Development and Commercialization of the Licensed Product in the Licensed Territory shall be made available to the other Party (or its designee) within [***] after such Party or its Affiliate distributes copies or summaries of such Development Data internally.
(c) During the Term, each Party shall promptly provide to the JSC (in the case of Zai, together with the Development reports submitted to the JSC pursuant to Section 4.6), or to the other Party upon the other Partys request, any Development Data generated pursuant to the Development Plan by or on behalf of such Party, its Affiliates, licensees or Sublicensees, to the extent not previously provided to the JSC or the other Party.
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(d) Each Party and its Affiliates may only use and disclose the Development Data during the Term for the purposes of exercising its rights and performing its obligations with respect to the Licensed Product in its territory (and with respect to Karuna, for purposes of exercising the Retained Rights) pursuant to this Agreement, including Development and regulatory activities with respect to the Licensed Product under this Agreement or its or their ongoing compliance with record retention requirements with respect to the Licensed Product by any Regulatory Authority in its territory; provided, for clarity, that neither Party nor its Affiliates will have any right to use or disclose any Development Data of the other Party as a comparator with, or in comparison to, any other compound or product without such other Partys prior written consent.
ARTICLE 5
REGULATORY
5.1. Zais Responsibilities.
(a) The regulatory strategy for the Licensed Territory will be consistent with the overall objectives of obtaining and maintaining Regulatory Approval of the Licensed Product in the Licensed Territory in accordance with the Development Plan. During the Term, subject to the oversight of the JSC, Zai shall, at its sole cost and expense, (i) be responsible for all regulatory activities leading up to and including the obtaining of the Regulatory Approval for the Licensed Product from the Regulatory Authority on a Region-by-Region basis in the Field in the Licensed Territory, at its sole cost and expense, except as set forth in the Global Development Plan and Development Plan; and (ii) to the extent permitted by Applicable Law, hold and maintain all Regulatory Approvals, Regulatory Submissions and all pricing and reimbursement approvals, in each case, for the Licensed Product in the Field in the Licensed Territory, in the name of Zai or its Affiliates, provided that, if Applicable Laws in a Region in the Licensed Territory do not allow Zai (or an Affiliate of Zai) to hold Regulatory Approvals or Regulatory Submissions for the Licensed Product in the Field in the Licensed Territory, then during the Term, Karuna will, at Zais costs, (A) hold such Regulatory Approval, Regulatory Submissions and pricing and reimbursement approvals for the Licensed Product in the Field in such Region solely for Zais benefit, (B) appoint Zai (or an Affiliate of Zai) as sole Authorized Regulatory Agent to handle all regulatory activities for the Licensed Product in the Field in such Region, and (C) shall promptly transfer such Regulatory Approval, Regulatory Submissions and pricing and reimbursement approvals to Zai or its designee when allowed by Applicable Laws.
(b) Zai shall use Commercially Reasonable Efforts to obtain and maintain, in its own name (or in the name of its Affiliates, but subject to Section 5.1(a)(ii)), Regulatory Approvals, Regulatory Submissions and pricing and reimbursement approvals (if applicable) for Licensed Product in the Field in each Region in the Licensed Territory in accordance with the Development Plan and Zai shall be [***]. During any period when Karuna holds any Regulatory Approval, Regulatory Submissions or pricing and reimbursement approvals for the Licensed Product in the Field in a Region for Zais benefit pursuant to Section 5.1(a)(ii), (i) Karuna shall not be obligated to [***]; (ii) Karuna shall not assume any liability [***]; (iii) should Karuna or its Affiliates incur any costs or expenses related to holding or transferring any such Regulatory Approval, Regulatory Submissions or pricing and reimbursement approvals, Zai shall [***]; and (iv) Zai shall [***].
(c) Zai shall keep Karuna promptly informed (and in any event within [***] for any significant matter) of regulatory developments related to the Licensed Product in each Region in the Licensed Territory and shall promptly notify Karuna in writing of any decision by any Regulatory Authority in such Region in the Licensed Territory regarding the Licensed Product. Zai shall share with Karuna copies of correspondences or a summary of phone calls received from and sent to any Regulatory Authority in each Region in the Licensed Territory relating to the Licensed Product promptly after (and in any event within [***] for any significant matter) Zai or its Affiliate distributes such copies or summaries internally.
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(d) [***].
(e) [***].
5.2. Review of Regulatory Submissions. Zai shall provide to Karuna for review and comment drafts of all material Regulatory Submissions (including application for HGR Approvals) in Field in the Licensed Territory for the Licensed Product no later than [***] prior to the planned submission, provided that, [***]. Zai shall incorporate any comments received from Karuna on such Regulatory Submissions where required under any Applicable Laws and shall use good faith efforts to incorporate any other comments received from Karuna on such Regulatory Submissions; provided that in the event of any disagreement regarding incorporation of comments made by Karuna with respect to the contents of any substantive proposals or Regulatory Submission for the Licensed Product in the Licensed Territory or any written correspondence with any Regulatory Authority for the Licensed Product in the Licensed Territory, the Parties shall discuss, through the JSC, such disagreements in good faith. In addition, Zai shall notify Karuna of any material Regulatory Submissions for the Licensed Product and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Licensed Territory and shall provide Karuna with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof [***].
5.3. Notice of Meetings. Zai shall provide Karuna with notice of any material meeting or discussion with any Regulatory Authority in the Licensed Territory related to the Licensed Product no later than [***] after receiving notice thereof. Zai shall lead any such meeting or discussion and Karuna or its designee shall have the right, but not the obligation, to attend and participate in any such meeting or discussion unless prohibited or restricted by Applicable Laws or Regulatory Authority. At Zais request, Karuna shall reasonably cooperate with Zai in preparing for any such meeting or discussion. If Karuna elects not to attend such meeting or discussion, then Zai shall provide to Karuna a written summary thereof in English promptly following the issuance or approval of the corresponding official minutes by the applicable Regulatory Authority.
5.4. Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai, its Affiliates, Sublicensees or Subcontractors, in each case, relating to the Licensed Product, then Zai shall notify Karuna of such contact, inspection, or notice or action within [***] after receipt of such notice (or, if action is taken without notice, within [***] of Zai becoming aware of such action). Karuna shall have the right to review and comment on any responses to any Regulatory Authority that pertain to the Licensed Product in the Licensed Territory.
5.5. Karunas Responsibilities. Subject to Section 4.4(d), Karuna shall reasonably cooperate with Zai in obtaining any Regulatory Approvals for the Licensed Product in the Licensed Territory by providing, to the extent reasonably requested by Zai, access to Regulatory Approvals, Regulatory Submissions, Development Data, and other information and documentation for the Licensed Product outside of the Licensed Territory if such information is required by Applicable Laws in the Licensed Territory or requested by a Regulatory Authority in the Licensed Territory in furtherance of such Regulatory Approvals for the Licensed Product in the Licensed Territory. In addition, upon Zais reasonable request, Karuna shall, and shall cause its Affiliates and sublicensees to provide to Zai copies of such records of Development, Manufacturing, and Commercialization activities to the extent required to obtain Regulatory Approval of the Licensed Product in the Licensed Territory. [***].
5.6. No Harmful Actions. If Karuna believes that Zai is taking or intends to take any action with respect to the Licensed Product that could have a material adverse impact upon the regulatory status of the Licensed Product outside the Licensed Territory, Karuna shall have the right to bring the matter to the attention of the JSC and the Parties shall discuss in good faith to resolve such concern. Without limiting the foregoing, unless the Parties otherwise agree: (a) Zai shall not communicate with any Regulatory Authority having jurisdiction outside the Licensed Territory, unless so ordered by such Regulatory Authority, in which case Zai shall immediately notify Karuna of such order; and (b) Zai shall not submit any Regulatory Submissions or seek Regulatory Approvals for the Licensed Product outside the Licensed Territory.
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5.7. Regulatory Authority Communications Received by a Party. Each Party shall keep the other Party informed in a timely manner, and compliant with the reporting requirements of the applicable Regulatory Authorities, of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority (inside or outside of the Licensed Territory as applicable) which: (a) raises any material concerns regarding the safety or efficacy of the Licensed Product; (b) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Licensed Product in the Field in the Licensed Territory; (c) is reasonably likely to lead to a recall or market withdrawal of the Licensed Product; (d) relates to expedited and periodic reports of Adverse Events with respect to the Licensed Product and which may have a material impact on obtaining or maintaining Marketing Approval or the continued commercialization of the Licensed Product in the Licensed Territory, as then conducted; or (e) relates to any dissatisfaction regarding the Licensed Product in the Licensed Territory of such a nature and magnitude that it is required under the Applicable Law to be collected, maintained and reported to a Regulatory Authority, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients. Each Party shall provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above. Karuna shall reasonably cooperate with and assist Zai in complying with regulatory obligations and communications, including by providing to Zai, in a timely manner upon request, such information and documentation in Karunas possession or Control as may be necessary for Zai to prepare a response to an inquiry from any Regulatory Authority regarding the Licensed Product in the Licensed Territory. To the extent there are any inconsistencies or conflicts between this Section 5.7 and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control, unless otherwise agreed to in writing by the Parties.
5.8. Adverse Events Reporting.
(a) Promptly following the Effective Date, but in no event later than [***] thereafter, Zai and Karuna shall develop and agree to the worldwide safety and pharmacovigilance procedures for the Parties with respect to the Licensed Product, such as safety data sharing and exchange, Adverse Events reporting and prescription events monitoring in a written agreement (the Pharmacovigilance Agreement). Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations. The Pharmacovigilance Agreement shall be promptly updated if required by changes in Applicable Law. Each Party hereby agrees to comply with its respective obligations under the Pharmacovigilance Agreement and to cause its Affiliates, licensees and sublicensees to comply with such obligations. To the extent there is any disagreement between this Section 5.8, Section 5.9, or any related definitions and the Pharmacovigilance Agreement, the Pharmacovigilance Agreement shall control with respect to safety matters and this Agreement shall control with respect to all other matters.
(b) Zai shall be responsible for complying with all Applicable Laws governing Adverse Events in the Licensed Territory for all Clinical Trials performed by or on behalf of Zai, its Affiliates, Subcontractors and Sublicensees, including the Local Studies and Joint Global Studies, and Karuna shall be responsible for complying with all Applicable Laws covering Adverse Events (i) in the Licensed Territory for all Clinical Trials performed by or on behalf of Karuna, its Affiliates, Subcontractors and licensees for the Global Studies that Zai does not participate in, and (ii) outside the Licensed Territory for all Clinical Trials.
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(c) Karuna shall hold and control the global safety database for all Licensed Product and for the exchange by the Parties in English of any information which a Party becomes aware of concerning any Adverse Event experienced by a subject or patient being administered the Licensed Product, including any such information received by either Party from any Third Party (subject to receipt of any required consents from such Third Party). It is understood that each Party and its Affiliates, licensees and sublicensees shall have the right to disclose such information if such disclosure is reasonably necessary to comply with Applicable Laws or requirements of any applicable Regulatory Authority.
5.9. Safety and Regulatory Audits. Upon reasonable notification, Karuna shall be entitled to conduct an audit of safety and regulatory systems, procedures and practices of Zai, its Affiliates, and Sublicensees (including Clinical Trial sites), in each case, relating to the Development of the Licensed Product in the Field in the Licensed Territory, including on-site evaluations. Karuna may conduct such audit no more than [***] (unless an additional audit is warranted for cause) upon [***] prior written notice to Zai. With respect to any inspection of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) by any Governmental Authority relating to the Licensed Product, Zai shall notify Karuna of such inspection (a) no later than [***] after Zai receives notice of such inspection or (b) within [***] after the completion of any such inspection of which Zai did not receive prior notice. Zai shall promptly provide Karuna with all information related to any such inspection. Zai shall also permit Governmental Authorities outside of the Licensed Territory to conduct inspections of Zai or its Affiliates or Sublicensees (including Clinical Trial sites) relating to the Licensed Product, and shall ensure that all such Affiliates or Sublicensees permit such inspections. [***]. Following any such regulatory inspection related to the Licensed Product, Zai shall provide Karuna with (i) an unredacted copy of any finding, notice, or report provided by any Governmental Authority related to such inspection (to the extent related to the Licensed Product) within [***] of Zai receiving the same, and (ii) [***]. Zai shall provide Karuna with a copy of any proposed response to such communications and shall consider in good faith Karunas reasonable comments with respect to such proposed response. Further details including notification, timing, response and scope of such audits shall be included in the Pharmacovigilance Agreement.
5.10. Remedial Actions. Each Party shall notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Licensed Product may be subject to any recall, corrective action or other regulatory action by any Governmental Authority or Regulatory Authority (as to Karunas notification obligation, only to the extent it would reasonably be expected to affect the Licensed Territory) (a Remedial Action). The Parties shall assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action with respect to the Licensed Territory. Zai shall have sole discretion with respect to any matters relating to any Remedial Action in the Field in the Licensed Territory (including decision to commence such Remedial Action), provided that, unless required by Regulatory Authorities or Applicable Law, Zai shall not commence such Remedial Action in the Field in the Licensed Territory without prior notice to Karuna, provided further that, Karuna shall have sole discretion with respect to any matters relating to any Remedial Action in the Licensed Territory to the extent related to any Global Study. The reasonable cost and expenses of any Remedial Action in the Licensed Territory shall be borne [***]. Zai shall, and shall ensure that its Affiliates and Sublicensees shall, maintain adequate records to permit the Parties to trace the distribution and use of the Licensed Product in the Licensed Territory.
ARTICLE 6
MANUFACTURING
6.1. Supply. During the Term, subject to the terms and conditions of this Agreement (including Karunas Retained Rights and Karunas obligations under Section 6.3), Zai shall have the sole right (and shall solely control, at its discretion) itself or with or through its Affiliates, Sublicensees, or other Third Parties, to Manufacture or have Manufactured the Compound and Licensed Product for use in Development (including Clinical Trials) in the Licensed Territory and for Commercialization in the Field in the Licensed Territory. Zai shall ensure that all Licensed Products Manufactured by or on behalf of Zai, its Affiliates, Sublicensees or Subcontractors shall comply with this Agreement, the specifications for the Licensed Product, other quality standards as mutually agreed by the Parties for the Licensed Product, and Applicable Laws in the applicable Region in the Licensed Territory (including applicable cGMP).
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6.2. Manufacturing Technology Transfer. At Zais request, the Parties shall (a) cooperate in good faith through the JSC to identify the Manufacturing Technology, and (b) Karuna shall use Commercially Reasonable Efforts to (i) transfer all Know-How within the Manufacturing Technology to Zai or its permitted designee (which designee may be an Affiliate or a Third Party manufacturer, and subject to Section 2.4), and (ii) provide reasonable assistance to Zai or such permitted designee, [***], in order to enable Zai and its designees to obtain the regulatory or governmental approvals necessary to authorize Zai and its designees to Manufacture the Compound or Licensed Product for clinical and commercial supply in the Licensed Territory (clauses (i) and (ii) together, the Manufacturing Technology Transfer). The Parties shall conduct the Manufacturing Technology Transfer in accordance with a mutually agreed transfer plan, including the timelines set forth therein, and Zai shall be fully responsible, at its own costs, for obtaining all licenses, permits and other certifications required by the applicable Regulatory Authorities in order to complete such Manufacturing Technology Transfer.
6.3. Supply by Karuna. Zai shall make a written request to Karuna to commence the Manufacturing Technology Transfer before [***]. Promptly after such request by Zai, and subject to Zai exercising Commercially Reasonable Efforts to conduct and complete the Manufacturing Technology Transfer set forth in Section 6.2, Karuna shall (either by itself or through an Affiliate or CMO) Manufacture and supply the Compound and Licensed Product to Zai for Development and Commercialization use in the Field in the Licensed Territory, until Zai is approved by applicable Regulatory Authorities to manufacture the Compound and Licensed Product (by itself or through an Affiliate or CMO) to support its Development and Commercialization of the Product in the Territory after the completion of the Manufacturing Technology Transfer set forth in Section 6.2. Karuna shall supply the Compound and Licensed Product to Zai at the Fully Burdened Manufacturing Cost plus [***] for Development use or, as the case may be, [***] for Commercialization use. Subject to further agreement by the Parties with respect to compliance with applicable cGMP and additional standards required by Regulatory Authorities or Applicable Laws in any particular Region in the Licensed Territory, all Compound and Licensed Product supplied by Karuna shall comply with applicable specifications, shall be manufactured in compliance with all Applicable Laws (including cGMP) of the country where such Compound and Licensed Product are manufactured, and shall be accompanied by a certificate of analysis and certificate of conformity as required under Applicable Laws. The Parties shall negotiate in good faith and agree on other detailed terms for such supply, including forecast, ordering, delivery, inspection, acceptance and other customary terms, which shall be set forth in one or more separate supply agreement and quality agreement.
ARTICLE 7
COMMERCIALIZATION
7.1. General; Commercialization. During the Term, and subject to the rights of Karuna as the Initial MAH, as set forth in this Agreement or otherwise required by Applicable Laws, Zai shall be solely responsible to Commercialize and obtain pricing and reimbursement approvals for the Licensed Product in the Field in the Licensed Territory in accordance with the Commercialization Plan, at its sole cost and expense. Without limiting the foregoing, for each Region in the Licensed Territory in which the Licensed Product receives Regulatory Approval, Zai shall use Commercially Reasonable Efforts to Commercialize the Licensed Product in the Field in such Region.
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7.2. Commercialization Plan. The Commercialization Plan shall contain in reasonable detail the significant Commercialization activities and the projected timelines for achieving such activities. Zai shall provide an initial Commercialization Plan to the JSC for review and discussion [***] of the first Regulatory Approval Application for the Licensed Product in the Licensed Territory, which shall include general information regarding marketing plans and budget estimates. Thereafter, Zai may propose updates or amendments to the Commercialization Plan to reflect necessary or material changes in such plans, including those in response to changes in the marketplace, relative success of the Licensed Product, and other relevant factors influencing such plan and activities, and submit such proposed updated or amended Commercialization Plan to the JSC. In preparing the initial Commercialization Plan and any updates or amendments thereto, Zai shall provide Karuna with an opportunity to comment and Zai shall consider any Karunas comments in good faith in finalizing the initial Commercialization Plan and any updates or amendments thereto.
7.3. Commercialization Reports. Zai shall update the JSC at each regularly scheduled JSC meeting regarding Commercialization activities conducted by Zai, its Affiliates and Sublicensees, in each case, with respect to the Licensed Product in Field the Licensed Territory. Each such update shall be in a form to be agreed by the JSC and shall summarize Zais, its Affiliates and Sublicensees significant Commercialization activities with respect to the Licensed Product in the Field in the Licensed Territory, covering subject matter at a level of detail reasonably required by Karuna and sufficient to enable Karuna to determine Zais compliance with its diligence obligations pursuant to this Agreement. In addition, Zai shall make available to Karuna such additional information about its Commercialization activities as may be reasonably requested by Karuna from time to time. All updates and reports generated pursuant to this Section 7.3 shall be the Confidential Information of Zai.
7.4. Pricing. Zai shall advise the JSC of its proposed pricing for the Licensed Product in each Region in the Licensed Territory prior to the anticipated filing of Regulatory Approval Application in such Region for the Licensed Product. Zai shall consider in good faith any comments provided by Karuna with respect to pricing of the Licensed Product sold in each Region. Zai shall keep Karuna informed on the status of any application for pricing and reimbursement approval for the Licensed Product in each Region in the Field and in the Licensed Territory, including any discussion with Regulatory Authority with respect thereto. Notwithstanding anything to the contrary in this Agreement (including Section 3.1(f)), Zai shall have the final decision-making authority on [***].
7.5. Product Trademarks. As soon as reasonably practicable following the Effective Date, but no later than [***] prior to the filing of any Regulatory Approval Application for the Licensed Product in each Region in the Licensed Territory, the Parties shall discuss in good faith a branding strategy for Commercialization of the Licensed Product in the Licensed Territory, including selection of any trademarks, logos and trademarks for use in connection with Commercialization of the Licensed Product in each Region in the Licensed Territory, which strategy shall be consistent with and subject to Karunas global branding strategy for the Licensed Product. Zai may use (pursuant to this Section 7.5) the trademarks Controlled by Karuna in the Licensed Territory as Karuna may provide to Zai in writing from time to time (the Karuna Product Marks) and may use the English mark thereof with Chinese phonetic translation below. Karuna hereby grants to Zai, during the Term and subject to the terms and conditions of this Agreement, a royalty-free, exclusive license under Karunas rights to use such Karuna Product Marks in connection with the Commercialization of the Licensed Product in the Field in the Licensed Territory in compliance with Applicable Laws and this Agreement. Zai shall comply with Karunas brand usage guidelines provided to Zai in its use of the Karuna Product Marks. Zai may also (in addition to or in lieu of the Karuna Product Marks) brand the Licensed Product in the Field in the Licensed Territory using its (and its Affiliates and Sublicensees) own corporate name or logo, and other trademarks, logos, and trade names specific for the Licensed Product that differ from the Karuna Product Marks and do not contain the name of Karuna; provided, however, that (a) such trademarks, logos and trade names shall not be confusingly similar to any of the trademarks Controlled by Karuna or any of its Affiliates, (b) prior to such use, Zai shall submit such trademarks, logos and trade names for Karunas prior written approval (not to be unreasonably withheld, delayed or conditioned), and (c) such trademarks, logos and trademarks shall be deemed owned by Zai (the Product Marks). Zai shall own all rights in the Product Marks in the Licensed Territory and shall register and maintain the Product Marks in the Licensed Territory that it determines reasonably necessary.
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7.6. No Diversion. To the extent permitted by Applicable Law, each Party hereby covenants and agrees that, with respect to Commercialization of the Licensed Product in the Field, (a) it shall not, and shall cause its Affiliates and contractually obligate its sublicensees not to, directly or indirectly, including via the Internet or mail order, engage in marketing to any Third Party or to any address or Internet Protocol address or the like, in the other Partys territory for the purposes of Commercializing the Licensed Product in the other Partys territory, (b) neither Party shall engage, nor permit its Affiliates, sublicensees to engage, in any advertising or promotional activities relating to the Licensed Product for use directed primarily to customers or other buyers or users of such product located in any country, Region or jurisdiction in the other Partys territory, or solicit orders from any prospective purchaser located in any country, Region or jurisdiction in the other Partys territory, and (c) if it receives any order or inquiry with respect to the Licensed Product from customers or any Third Party outside its territory, it shall direct such order or inquiry to the other Party. For clarity, Karunas territory means anywhere in the world other than the Licensed Territory.
7.7. Transfer of Compound; Audits. Zai shall not, and shall ensure that its Affiliates and Sublicensees do not, directly or indirectly, sell, resell, donate, assign, hypothecate, export, distribute, transfer or divert the Compound or Licensed Product to an entity other than Zai, or an entity approved by Zai, in each case outside the Licensed Territory or otherwise in a manner that would cause the sale of such Compound or Licensed Product in the chain of distribution (from Zai or its Affiliates or Sublicensees to the end user) to be excluded (except as an exception provided in the Net Sales definition) in the calculation of Net Sales, provided that for each unit of the Compound or Licensed Product, the inclusion of such sales in the calculation of Net Sales shall occur only once. Subject to Applicable Laws, upon Karunas reasonable request and [***], but no more often than once in every [***], Zai (either directly or indirectly through its sublicenses or designees) shall allow Karuna to perform an audit, site visit or similar inspection of any site or facility where Development or Commercialization activities for the Licensed Product are being conducted to ensure (i) compliance with applicable cGMP, GCP, GLP, and GSP standards, and (ii) compliance with this Section 7.7.
7.8. Medical Affairs. Zai shall be solely responsible, at its sole cost and expense, for conducting medical affairs activities with respect to the Licensed Product in the Field in the Licensed Territory, including communications with key opinion leaders, medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), publications, congress presentations and posters, published manuscripts, activities performed in connection with patient registries and post-approval trials, and other medical programs and communications, including educational grants, research grants (including conducting investigator-initiated studies), and charitable donations to the extent related to medical affairs and not to other activities that do not involve the promotion, marketing, sale, or other Commercialization of the Licensed Product, all of which shall be conducted in accordance with Applicable Law. Zai shall update the JSC at each regularly scheduled JSC meeting regarding Zais medical affairs activities. All updates and reports generated pursuant to this Section 7.8 shall be the Confidential Information of Zai.
ARTICLE 8
PAYMENTS AND MILESTONES
8.1. Upfront Payment. Zai shall pay to Karuna an one-time, irrevocable, non-refundable, non-creditable amount of thirty-five million U.S. Dollars ($35,000,000) (the Upfront Payment) within [***] after the Effective Date.
8.2. Development Milestones Payments to Karuna.
(a) Subject to the remainder of this Section 8.2, within [***] after the Licensed Product first achieves each of the Milestone Events set forth below (each such event, a Development Milestone Event), the Party that achieves such Milestone Event shall notify the other Party. Zai shall pay to Karuna the corresponding one-time, irrevocable, non-refundable, non-creditable Development Milestone Payments (each such payment, a Development Milestone Payment) within [***] after the receipt of an invoice for such payment issued pursuant to Section 8.5(c) after the receipt of such notice.
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Development Milestone Event |
Development Milestone Payment |
|||
1) [***] |
$ | [***] | ||
2) [***] |
$ | [***] | ||
3) [***] |
$ | [***] | ||
4) [***] |
$ | [***] | ||
5) [***] |
$ | [***] | ||
6) [***] |
$ | [***] | ||
7) [***] |
$ | [***] | ||
|
|
|||
Total: |
$ | [***] |
(b) For the avoidance of doubt, (i) each Development Milestone Payment shall be payable on the first occurrence of the corresponding Development Milestone Event for the Licensed Product, and (ii) none of the Development Milestone Payments shall be payable more than once.
(c) [***].
(d) [***].
(e) [***].
(f) [***].
(g) [***].
8.3. Sales Milestones.
(a) Zai shall pay to Karuna the following one-time, irrevocable, non-refundable, non-creditable Milestone Payments (each such payment, a Net Sales Milestone Payment) for the achievement of the corresponding Net Sales Milestone Events set forth below (each such event, a Net Sales Milestone Event) within [***] after the receipt of an invoice for such payment issued pursuant to Section 8.5(c) after the end of the Calendar Year in which the Net Sales Milestone Event is achieved.
Net Sales Milestone Event First time annual Net Sales of the Licensed
Product in the Licensed |
Net Sales Milestone Payment |
|||
1) $[***] |
$ | [***] | ||
2) $[***] |
$ | [***] | ||
3) $[***] |
$ | [***] | ||
|
|
|||
Total: |
$ | [***] |
(b) For the avoidance of doubt each Net Sales Milestone Payment shall be payable on the first occurrence of the corresponding Net Sales Milestone Event, and if annual Net Sales in a given Calendar Year exceed more than one (1) applicable threshold, then all corresponding Net Sales Milestone Payments shall be payable. Licensed Products sold after the expiration of the Royalty Term shall not be included in the calculation of annual Net Sales to determine whether any Net Sales threshold has been achieved.
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8.4. Royalties.
(a) Royalty Payment. During the Royalty Term, Zai shall pay to Karuna tiered royalties as calculated by multiplying the applicable royalty rate set forth in the table below by the corresponding amount of incremental, aggregated Net Sales of all Licensed Products in the Licensed Territory (other than Hong Kong) in a Calendar Year (a Royalty Payment). Each Royalty Payment shall be non-creditable, irrevocable, and non-refundable. The tiered royalty rates on Net Sales shall be as set forth below:
For that portion of annual aggregated Net Sales of all Licensed
Products in the Licensed Territory |
Royalty Rate |
|||
1) [***] |
[ | ***]% | ||
2) [***] |
[ | ***]% | ||
3) [***] |
[ | ***]% | ||
4) [***] |
[ | ***]% |
(b) Royalty Term. The Royalty Payments payable under this Section 8.4 shall be payable on the Licensed Product-by-Licensed Product and Region-by-Region basis from the First Commercial Sale of the applicable Licensed Product in such Region until the latest of: (i) the date the last-to-expire Valid Claim in such Region expires; (ii) the close of business of the day that is exactly twelve (12) years after the date of the First Commercial Sale of the Licensed Product in such Region; and (iii) the expiration date of any Regulatory Exclusivity for the Licensed Product in such Region (the Royalty Term). Licensed Products sold after the expiration of the Royalty Term shall not be included in the calculation of annual Net Sales to determine the applicable royalty tiers.
(c) Royalty Reductions.
(i) During the Royalty Term, on the Licensed Product-by-Licensed Product and Region-by-Region basis, subject to Section 8.4(c)(vi), the royalty rate applicable to Net Sales of the Licensed Product in such Region shall be reduced by [***] after the expiration of the last-to-expire Valid Claim in such Region.
(ii) During the Royalty Term, on the Licensed Product-by-Licensed Product and Region-by-Region basis, subject to Section 8.4(c)(vi), if at any time during a Calendar Quarter following receipt of all necessary Regulatory Approvals from the applicable Regulatory Authorities in such Region to market and sell such Third Party Product as a pharmaceutical product for one or more Indications for the corresponding Licensed Product in such Region (the Generic Launch Quarter), the applicable royalty rate for Net Sales, in such Region for such Licensed Product shall be reduced as follows: (A) if for any Calendar Quarter after the Generic Launch Quarter the comparable unit sales of the Third Party Product(s) in such Region is greater than [***] but equal to or less than [***] of the comparable unit sales of such Licensed Product, then the royalty payments owed by the Zai for such Licensed Product in such Region for such Calendar Quarter shall be reduced by [***], and (B) if for any Calendar Quarter after the Generic Launch Quarter the comparable unit sales of the Third Party Product(s) in such Region is greater than [***] of the comparable unit sales of such Licensed Product, then the royalty payments owed by Zai for such Licensed Product in such Region for the remainder of the Royalty Term shall be reduced by [***].
(iii) [***].
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(iv) [***].
(v) If Zai reasonably determines in good faith after advice of counsel that it is [***] and enters into such a license, subject to Section 8.4(c)(vi), on the Licensed Product-by-Licensed Product and Region-by-Region basis, Zai shall have the right to deduct, from the Royalty Payment that would otherwise have been due pursuant to this Section 8.4, an amount equal to [***] of the royalties paid by Zai to such Third Party pursuant to such license on account of the sale of the Licensed Product in such Region the Licensed Territory; provided that (A) prior to entering into such license, Zai shall [***]; and (B) in the event [***]. Within [***] following the execution of any such Third Party license, Zai shall provide Karuna with a true and complete copy of such Third Party license.
(vi) Notwithstanding the foregoing, in no event shall the operation of Section 8.4(c)(i) through 8.4(c)(v), individually or in combination, reduce the royalties payable by Zai to Karuna with respect to the Net Sales of the Licensed Product in any Region in the Licensed Territory in any Calendar Quarter to an amount less than [***] of the amount that would otherwise have been due pursuant to Section 8.4(a) with respect to such Net Sales.
(d) Royalty Reports. Following the First Commercial Sale of the Licensed Product for which royalties are due pursuant to this Section 8.4, and continuing for so long as royalties are due hereunder:
(i) Zai shall, within [***] after the end of each Calendar Quarter, provide Karuna with a royalty report (in a template agreed to by the Parties) showing, on a Region-by-Region basis:
(1) [***];
(2) [***];
(3) [***];
(4) [***];
(5) [***];
(6) [***];
(7) [***].
(e) Royalty Payment. Concurrently with each royalty report provided by Zai under Section 8.4(d) above, Zai shall pay to Karuna applicable royalties for each Calendar Quarter within [***] after the end of such Calendar Quarter. If no royalty is due for any Calendar Quarter following commencement of the reporting obligation, Zai shall so report.
8.5. Payment.
(a) Mode of Payment. All payments to be made under this Agreement shall be made in U.S. Dollars and shall be paid by electronic transfer in immediately available funds to such bank account in the United States as is designated in writing by Karuna. All payments shall be free and clear of any transfer fees or charges.
(b) Currency Exchange Rate. All payments under this Agreement shall be payable in U.S. Dollars. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars for calculating Net Sales in a Calendar Quarter (for purposes of both the royalty calculation and whether a Net Sales milestone has been achieved) shall be made at the average exchange rate as published by the Wall Street Journal for such Calendar Quarter, or such other source as the Parties may agree in writing.
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(c) Payment Timeline. Except as otherwise provided herein, all payments to be made by one Party to the other Party under this Agreement require a corresponding invoice and shall be due within [***] (or such other time period set forth herein) following such Partys receipt of an invoice from the other Party.
8.6. Audits.
(a) Zai shall keep, and shall require its Affiliates and Sublicensees to keep (all in accordance with the GAAP or IFRS), for a period not less than [***] from the end of the Calendar Year to which they pertain, complete and accurate records in sufficient detail to properly reflect Net Sales and to enable any Milestone Payment payable hereunder to be determined.
(b) Upon the written request of Karuna, Zai shall permit, and shall cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of nationally recognized standing selected by Karuna and reasonably acceptable to Zai, at Karunas expense, to have access during normal business hours to such records of Zai or its Affiliates as may be reasonably necessary to verify the accuracy of the payments hereunder for any Calendar Year ending not more than [***]. These rights with respect to any Calendar Year shall [***] the end of any such Calendar Year and shall be limited to once each Calendar Year (provided that the foregoing frequency limit shall not apply if Karuna has reasonable cause). The accounting firm shall provide Karuna and Zai with a written report [***]. If such accounting firm concludes that an underpayment was made, then Zai shall pay the amount due within [***] after receipt of such accounting firms written report so concluding. If such accounting firm concludes that an overpayment was made, then such overpayment shall be credited against any future payment due to Karuna hereunder (if there is no future payment due, then Karuna shall promptly refund such overpayment to Zai). Karuna shall bear the full cost of such audit unless such audit discloses that the additional payment payable by Zai for the audited period is more than [***] of the amount otherwise paid for that audited period, in which case Zai shall pay the reasonable fees and expenses charged by the accounting firm.
(c) Zai shall include in each relevant sublicense granted by it a provision requiring any Sublicensee to maintain records of sales of Licensed Product made pursuant to such sublicense, and to grant access to such records by an accounting firm to the same extent and under the same obligations as required of Zai under this Agreement. Karuna shall advise Zai in advance of each audit of any such Sublicensee with respect to the Net Sales of the Licensed Product either by Karuna or its designated auditor under the terms of such Sublicensee agreement. The accounting firm shall provide Karuna and Zai with a copy of the audit report at the same time. Karuna shall pay the full costs charged by the accounting firm, unless the audit discloses that the additional payments payable to Karuna for the audited period is more than [***] from the amounts otherwise paid for that audited period, in which case Zai shall pay the reasonable fees and expenses charged by the accounting firm.
8.7. Interest. Each Party shall pay interest on any amounts overdue under this Agreement [***] from the day payment was initially due; provided, however, that in no case shall such interest rate exceed the highest rate permitted by Applicable Laws. The payment of such interest shall not foreclose a Party from exercising any other rights it may have because any payment is overdue.
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8.8. Taxes.
(a) Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law (other VAT and Withholding VAT Taxes described in 9.8(c)). The Party that is required to make such withholding shall: (i) timely remit the taxes to the proper taxing authority; and (ii) send evidence of the obligation, together with proof of tax payment, to the other Party on a timely basis following such tax payment. Each Party shall reasonably cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 8.8 are reduced in amount to the fullest extent permitted by Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as VAT, sales tax, consumption tax, and other similar taxes) in connection with this Agreement. In the event of any such any withholding is required to be withheld and deducted from payments by Zai (or its Affiliate paying on behalf of Zai) pursuant to this Agreement under Applicable Laws, notwithstanding anything to the contrary herein, [***].
(b) [***]. If Zai is required to deduct or withhold any VAT on any payments payable by Zai under this Agreement (the Withholding VAT Taxes), Zai will (i) pay such Withholding VAT Tax on behalf of Karuna to the appropriate Governmental Authority, (ii) furnish Karuna with proof of payment of such Withholding VAT Tax within [***] following such payment, and (iii) [***]. Zai will promptly provide to Karuna applicable receipts evidencing payment of such Withholding VAT Taxes and other documentation reasonably requested by Karuna. Upon Zais request, Karuna shall provide reasonable assistance to Zai for Zai to recover any such Withholding VAT Taxes. For clarity, [***].
8.9. Blocked Currency. If by Applicable Laws in a Region in the Licensed Territory, conversion into Dollars or transfer of funds of a convertible currency to the United States becomes materially restricted, forbidden or substantially delayed, then Zai shall promptly notify Karuna and, thereafter, amounts accrued in such country or region under this ARTICLE 8 shall be paid to Karuna (or its designee) in such country or Region in local currency by deposit to an escrow account in a local bank designated by Karuna and to the credit of Karuna, unless the Parties otherwise agree.
ARTICLE 9
CONFIDENTIALITY; PUBLICATION
9.1. Nondisclosure Obligation.
(a) For the Term and [***] thereafter, the Party receiving (the Receiving Party) the Confidential Information of the other Party (the Disclosing Party) shall keep confidential and not publish, make available or otherwise disclose any Confidential Information to any Third Party, without the express prior written consent of the Disclosing Party; provided, however, the Receiving Party may disclose certain Confidential Information to those of its Affiliates, officers, directors, employees, agents, consultants or independent contractors, existing and potential licensees, sublicensees, upstream licensors, and bona-fide purchasers of such Receiving Party who need to know such Confidential Information in connection with exercising rights or performing obligations as contemplated by this Agreement or any other written agreement between the Parties and are bound by confidentiality and non-use obligations with respect to such Confidential Information consistent with those set forth herein; the Receiving Party shall remain responsible for the compliance by its Affiliates, officers, directors, employees, agents, consultants or independent contractors (including licensees and sublicensees) with such confidentiality and non-use obligations. Either Party may disclose the terms and existence of this Agreement to any bona fide existing or potential investors, lenders and acquirers and the accountants and advisors of any of the foregoing who are bound by a written agreement (or in the case of attorneys or other professional advisors, formal ethical duties) requiring such recipients to treat, hold and maintain the terms of this Agreement as confidential information in a manner that is consistent with the terms and conditions of this Agreement. The Receiving Party shall exercise at a minimum the same degree of care it would exercise to protect its own Confidential Information (and in no event less than a reasonable standard of care) to keep confidential the Confidential Information. The Receiving Party shall use the Confidential Information solely in connection with exercising rights or performing obligations as contemplated by this Agreement or any other written agreement between the Parties.
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(b) It shall not be considered a breach of this Agreement if the Receiving Party discloses Confidential Information or either Party discloses the terms and conditions of this Agreement in order to comply with a lawfully issued court or governmental order or with a requirement of Applicable Laws or the rules of any internationally recognized stock exchange; provided that: (i) the Receiving Party gives prompt written notice of such disclosure requirement to the Disclosing Party and cooperates with the Disclosing Partys efforts to oppose such disclosure or obtain a protective order for such Confidential Information, and (ii) if such disclosure requirement is not quashed or a protective order is not obtained, the Receiving Party shall only disclose those portions of the Confidential Information that it is legally required to disclose and shall make a reasonable effort to obtain confidential treatment for the disclosed Confidential Information. To the extent there is any conflict between this ARTICLE 9 and any other agreement related to Confidential Information entered into between the Parties, including the Confidentiality Agreement, the terms of this ARTICLE 9 shall control to the extent of such conflict.
(c) Scientific Publication. The JSC shall discuss the publication strategy for the publication of scientific papers, abstracts, meeting presentations and other disclosure of the results of the Clinical Trials carried out under this Agreement, taking into consideration the Parties interest in publishing the results of the Licensed Product Development work in order to obtain recognition within the scientific community and to advance the state of scientific knowledge, and the need to protect Confidential Information, intellectual property rights and other business interests of the Parties; provided that Zais publication outside the Licensed Territory (including in any form or media that may be distributed outside the Territory) shall require Karunas prior written consent, not to be unreasonably withheld. Zai shall provide Karuna with the opportunity to review and comment on any proposed publication [***] that pertains to the Licensed Product at least [***] prior to its intended submission for publication, which shall be limited to data, results and the like with respect to patients or subjects located in the Licensed Territory. Karuna shall provide Zai with its comments, if any, within [***] after the receipt of such proposed publication. Zai shall consider in good faith the comments provided by Karuna and shall comply with Karunas request to: (a) remove any and all Confidential Information of Karuna from such proposed publication; and (b) if Karuna determines that such publication would entail the disclosure of patentable Inventions upon which patent applications should be filed prior to such publication, delay the submission for a period as may be reasonably necessary for the drafting and filing of a patent application covering such Inventions; provided that such additional period shall not exceed [***] from the proposed date of the intended submission for publication. Zai agrees to acknowledge the contribution of Karuna and its employees in all publications as scientifically appropriate.
9.2. Publication and Listing of Clinical Trials. With respect to the listing of Clinical Trials or the publication of Clinical Trial results for the Licensed Product and to the extent applicable to a Partys activities conducted under this Agreement, each Party shall comply with (a) the Pharmaceutical Research and Manufacturers of America (PhRMA) Guidelines on the listing of Clinical Trials and the Publication of Clinical Trial results, and (b) any Applicable Law or applicable court order, stipulations, consent agreements, and settlements entered into by such Party. The Parties agree that any such listings or publications made pursuant to this Section 9.2 shall be considered a publication for purposes of this Agreement and shall be subject to Section 9.1.
9.3. Publicity; Use of Names.
(a) Subject to permitted disclosures under Section 9.1, each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except to (i) advisors (including consultants, financial advisors, attorneys and accountants), (ii) bona fide potential and existing investors, acquirers, merger partners or other financial or commercial partners on a need to know basis for the sole purpose of evaluating an actual or potential investment, acquisition or other business relationship, in each case under circumstances that reasonably protect the confidentiality thereof, or (iii) to the extent required by Applicable Laws, including securities laws and regulations. Notwithstanding the foregoing, the Parties agree to issue the initial press release(s) to announce the execution of this Agreement as contained in Schedule 9.3(a); thereafter, Karuna and Zai may each disclose to Third Parties the information contained in such press release(s) or in any other press releases or disclosures made in accordance with this Section 9.3, without the need for further approval by the other.
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(b) The Parties acknowledge the importance of supporting each others efforts to publicly disclose results and significant developments regarding the Licensed Product for use in the Field in the Licensed Territory and other activities in connection with this Agreement, beyond what may be strictly required by Applicable Laws and the rules of a recognized stock exchange, and each Party may make such disclosures from time to time with respect to the Licensed Product in each case with the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed. Such disclosures may include achievement of significant events in the Development (including regulatory process) or Commercialization of the Licensed Product for use in the Field in the Licensed Territory. Unless otherwise requested by the applicable Party, Zai shall indicate that Karuna is the licensor of the Licensed Product and Licensed Technology in each public disclosure issued by Zai regarding the Licensed Product. When Zai elects to make any public disclosure under this Section 9.3(b) or Karuna elects to make any public disclosure regarding results and significant developments regarding the Licensed Product for use in the Field in the Licensed Territory under this Section 9.3(b), the disclosing Party shall give the other Party at least [***]prior to its intended disclosure to review and comment on such statement, it being understood that (i) if the other Party does not notify such Party in writing within [***] or such shorter period if required by Applicable Laws of any reasonable objections, as contemplated in this Section 9.3(b), such disclosure shall be deemed approved, and (ii) if the other Party does notify such Party in writing within the time period set forth in clause (i) above, and reasonably determines that such public disclosure would entail the public disclosure of the other Partys Confidential Information or of patentable Inventions upon which patent applications should be filed prior to such public disclosure, such public disclosure shall be delayed for such period as may be reasonably necessary for deleting any such Confidential Information of the other Party, or the drafting and filing of a patent application covering such Inventions; provided that such additional period shall not exceed [***] from the proposed date of the public disclosure, and, in any event, the other Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Laws and regulatory guidance documents, and reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities.
(c) The Parties acknowledge the need to keep investors and others informed regarding such Partys business under this Agreement, including as required by Applicable Laws or the rules of a recognized stock exchange. To the extent a Party is publicly listed or becomes publicly listed, and subject to Section 9.3(b) as applicable, such Party may issue press releases or make disclosures to the SEC or other applicable agency as it determines, based on advice of counsel, as reasonably necessary to comply with Applicable Laws; provided that each Party shall provide the other Party with reasonable advance notice of such legally required disclosures. The Parties shall consult with each other on the provisions of this Agreement to be redacted in any filings made by a Party with the SEC or as otherwise required by Applicable Laws; provided that each Party shall have the right to make any such filing as it reasonably determines necessary under Applicable Laws.
(d) The Parties agree and acknowledge that, upon reasonable request by Zai and subject to mutual agreement by the Parties, Zai may record or file this Agreement (or a summary or translation of this Agreement as is necessary to effect such recordation or filing) with any patent and trademark office or similar authority in the Licensed Territory, if Zai reasonably determines that such recordation or filing is beneficial or required to give effect to or protect its rights under this Agreement. Upon Zais reasonable request, Karuna shall provide such cooperation and reasonable assistance in connection with such recordation or filing.
9.4. Prior Confidentiality Agreement. As of the Effective Date, the terms of this ARTICLE 9 shall supersede any prior non-disclosure, secrecy or confidentiality provisions in any agreement between the Parties (or their Affiliates) relating to the subject of this Agreement, including such provisions in the Confidentiality Agreement.
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ARTICLE 10
REPRESENTATIONS, WARRANTIES, AND COVENANTS
10.1. Representations and Warranties of Each Party. Each Party represents and warrants to the other Party as of the Effective Date that:
(a) it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder;
(b) (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to the general principles of equity and subject to bankruptcy, insolvency, moratorium, judicial principles affecting the availability of specific performance and other similar laws affecting the enforcement of creditors rights generally;
(c) it is not a party to any agreement that would prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement, including any Existing In-License Agreement; and
(d) all consents, approvals and authorization from all Governmental Authorities or other Third Parties required to be obtained by such Party in connection with execution of this Agreement have been obtained.
10.2. Additional Representations, Warranties and Covenants of Karuna. Karuna represents, warrants and covenants to Zai that as the Effective Date with respect to itself and its Affiliates:
(a) Karuna and its Affiliates are the sole owners or exclusive licensees of the Licensed Patents and material Licensed Know-How, and Karuna has the right under the Licensed Technology to grant the licenses to Zai as purported to be granted pursuant to this Agreement;
(b) Schedule 1.79 sets forth a complete and accurate list all Licensed Patents as of the Effective Date;
(c) neither Karuna nor any of its Affiliates is a party to any license or similar agreement under which it has granted or agreed to grant a license to any Third Party to any Licensed Technology that would conflict with the rights or licenses granted to Zai under this Agreement;
(d) neither Karuna nor any of its Affiliates will grant any license, sublicense or other rights in or to the Licensed Technology which is inconsistent with the terms and conditions of this Agreement;
(e) Karuna and its Affiliates and their employees, consultants and contractors involved in the Development of the Compound and Licensed Product are not, and have not been, debarred or disqualified by any Regulatory Authority as of the Effective Date, and have complied in all material respects with all Applicable Laws in connection with the Development of the Compound and Licensed Product;
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(f) no claim or action has been brought against Karuna or, to Karunas knowledge, threatened in writing to Karuna, by any Third Party alleging that (i) the Licensed Patents are invalid or unenforceable, or (ii) the Exploitation of the Compound or Licensed Product infringes the Patents or misappropriates the Know-How of any Third Party;
(g) to its knowledge, the Exploitation of the Compound and Licensed Product does not infringe or misappropriate any Patent or Know-How of any Third Party;
(h) it is not aware of any infringement or misappropriation of any Licensed Technology by any Third Party;
(i) except for the Existing In-License Agreements listed on Schedule 1.42, there is no material in-license agreement between Karuna or its Affiliates with any Third Party pursuant to which Karuna or its Affiliates has obtained Control to any Licensed Technology;
(j) it has provided Zai with true and complete copy of each Existing In-License Agreement, and each Existing In-License Agreement is in full force and effect; no notice of default or termination has been received or given under any Existing In-License Agreement and, to its knowledge, there is no act or omission by Karuna or its Affiliates that would provide a right to terminate any Existing In-License Agreement;
(k) it will not knowingly breach any Existing In-License Agreement (and New Karuna In-License, if any); it will not terminate, modify or amend the Existing In-License Agreement (and New Karuna In-License, if any), or exercise, waive, release, or assign any rights thereunder, in any manner that would limit, restrict or otherwise materially adversely affect the rights of Zai hereunder without obtaining Zais prior written consent;
(l) in the event of any notice of breach of any Existing In-License Agreement (and New Karuna In-License, if any) by Karuna or its Affiliate, Karuna will as promptly as practicable notify Zai in writing, and will use Commercially Reasonable Efforts to cure such breach, or, if Karuna reasonably determines that it has not committed such breach, use Commercially Reasonable Efforts to resolve such dispute;
(m) in the event of any notice of breach of any Existing In-License Agreement (and New Karuna In-License, if any) by the applicable counter party in a manner that will or is likely to materially adversely affect Zais rights or obligations under this Agreement, Karuna will as promptly as practicable notify Zai in writing, and will use Commercially Reasonable Efforts to enforce such Existing In-License Agreement (and New Karuna In-License, if any) or resolve such dispute; and
(n) all information provided by Karuna to Zai for due diligence purposes in relation to this Agreement is complete and accurate in all material respects. Without limiting the foregoing, it has disclosed or made available to Zai for review all material non-clinical and clinical data for the Compound and Licensed Product, and all other material information (including relevant correspondence with Regulatory Authorities) relating to the Compound and Licensed Product, in each case that would be material for Zai to assess the safety and efficacy of the Compound and Licensed Product.
10.3. Additional Representations, Warranties and Covenants of Zai. Zai represents, warrants and covenants to Karuna that as of the Effective Date with respect to itself and its Affiliates:
(a) there are no legal claims, judgments or settlements against or owed by Zai or its Affiliates (nor any of their respective directors, officers, employees, Affiliates, nor any Person authorized to act on behalf of Zai or its Affiliates), or pending or, to Zais or its Affiliates actual knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations, including under any Anti-Corruption Laws; and
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(b) Zai and its Affiliates are not, and have not been, debarred or disqualified by any Regulatory Authority;
(c) Zai has sufficient financial wherewithal (at the time when such financial resources are required) to (i) perform all of its obligations pursuant to this Agreement, and (ii) meet all of its obligations that come due in the ordinary course of business;
(d) Zai shall, in the course of performing its obligations or exercising its rights under this Agreement, and shall cause its Affiliates, Sublicensees and Subcontractors to, in all material aspects comply with the Development Plan, all agreements referenced herein, all Applicable Laws, including as applicable, cGMP, GCP, GLP, and GSP standards, and shall not employ or engage any party who has been debarred by any Regulatory Authority, or, to its knowledge, is the subject of debarment proceedings by a Regulatory Authority;
(e) Zai shall perform, and shall cause its Affiliate and Sublicensees and their respective Subcontractors to perform, all necessary or required record filings with and obtain all necessary or required licenses, approvals and permits from, all applicable Governmental Authorities in the Licensed Territory (including the HGR Approvals) for the conduct of Development activities and sharing of any data or information under this Agreement, and shall provide Karuna with copies of such record filings, licenses, approvals, and permits, [***].
10.4. Compliance with Anti-Corruption Laws.
(a) Notwithstanding anything to the contrary in this Agreement, each Party hereby covenants to each other that:
(i) it shall not, in the performance of this Agreement, perform any actions that are prohibited by local and other anti-corruption laws (collectively Anti-Corruption Laws, including the provisions of the U.S. Foreign Corrupt Practices Act, the U.K. Anti-Bribery Law, and the PRC Anti-Unfair Competition Law and the PRC Criminal Law, in each case, as amended) that may be applicable to either or both Parties to this Agreement;
(ii) it shall not, in the performance of this Agreement, directly or indirectly, make any payment, or offer or transfer anything of value, or agree or promise to make any payment or offer or transfer anything of value, to a government official or government employee, to any political party or any candidate for political office or to any other Third Party with the purpose of influencing decisions related to either Party or its business in a manner that would violate Anti-Corruption Laws;
(iii) it shall, on request by the other Party, conduct reasonable investigation to verify that there has not been any violation of Anti-Corruption Laws by such Party or persons employed by or subcontractors (including, in the case of Zai, any Sublicensees or Subcontractors) used by such Party in the performance of this Agreement;
(iv) it shall maintain records (financial and otherwise) and supporting documentation related to the subject matter of this Agreement in order to document or verify compliance with the provisions of this Section 10.4, and upon request of the other Party, upon reasonable advance notice, shall provide a Third Party auditor mutually acceptable to the Parties with access to such records for purposes of verifying compliance with the provisions of this Section 10.4. Acceptance of a proposed Third Party auditor may not be unreasonably withheld or delayed by either Party. It is expressly agreed that the costs related to the Third Party auditor shall be fully paid by the Party requesting the audit (unless such audit identifies any violation of the obligations under this Section 10.4, in which case the audited Party shall bear all the costs), and that any auditing activities may not unduly interfere with the normal business operations of Party subject to such auditing activities. The audited Party may require the Third Party auditor to enter into a reasonable confidentiality agreement in connection with such an audit.
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(b) To its knowledge as of the Effective Date and during the Term, neither Zai nor any of its subsidiaries nor any of their Affiliates, directors, officers, employees, distributors, agents, representatives, sales intermediaries or other Third Parties acting on behalf of Zai or any of its subsidiaries or any of their Affiliates:
(i) has taken or shall take any action in violation of any applicable anticorruption law, including the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78 dd-1 et seq.); or
(ii) has corruptly, offered, paid, given, promised to pay or give, or authorized or shall corruptly, offer, pay give, promise to pay or give or authorize, the payment or gift of anything of value, directly or indirectly, to any Public Official (as defined in Section 10.4(d) below), for the purposes of:
(iii) has influenced or shall influence any act or decision of any Public Official in his or her official capacity;
(iv) has induced or shall induce such Public Official to do or omit to do any act in violation of his lawful duty;
(v) has secured or shall secure any improper advantage; or
(vi) has induced or shall induce such Public Official to use his or her influence with a government, governmental entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled veterinary or medical facilities) in obtaining or retaining any business whatsoever.
(c) As of the Effective Date, none of the officers, directors, employees of Zai or of any of its Affiliates or agents acting on behalf of Zai or any of its Affiliates, in each case that are employed or reside outside the United States, are themselves Public Officials.
(d) For purposes of this Section 10.4, Public Official means (i) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency or other division; (ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state-owned or controlled veterinary or medical facility; (iii) any officer, employee or representative of any public international organization, such as the International Monetary Fund, the United Nations or the World Bank or similar organizations in each Region in the Licensed Territory; and (iv) any person acting in an official capacity for any government or government entity, enterprise or organization identified above.
10.5. NO OTHER REPRESENTATIONS OR WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
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ARTICLE 11
INDEMNIFICATION
11.1. By Zai. Zai shall indemnify and hold harmless Karuna, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the Karuna Indemnitee(s)) from and against all losses, liabilities, damages and expenses (including reasonable attorneys fees and costs) (individually and collectively, Losses) incurred by them in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, Claims) arising after the Effective Date to the extent arising from (a) the Exploitation of the Licensed Product in the Licensed Territory, including promotion of the Licensed Product and any actions (or omissions) in the performance of its regulatory activities, in each case by Zai or any of its Affiliates, Sublicensees, or Subcontractors, (b) the gross negligence, illegal conduct or willful misconduct of Zai or any of its Affiliates or Sublicensees, (c) Zais breach of any of its representations, warranties or covenants made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement, or (d) Karuna holding any Regulatory Approval, Regulatory Submission or pricing and reimbursement approval for the Licensed Product for Zais benefit in accordance with Section 5.1, in each case of clauses (a) through (d) above except to the extent such Losses arise from, are based on, or result from any activity or occurrence for which Karuna is obligated to indemnify the Zai Indemnitees under Section 11.2.
11.2. By Karuna. Karuna shall indemnify and hold harmless Zai, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the Zai Indemnitee(s)) from and against all Losses incurred by them in connection with any Claims to the extent arising from (a) Exploitation of the Compound and Licensed Product outside the Licensed Territory, including the promotion of the Licensed Product and any actions (or omissions) in the performance of its regulatory activities, in each case by Karuna or any of its Affiliates or licensees (other than Zai or its Affiliates or Sublicensees), or in the Licensed Territory with respect to Global Studies or any Manufacturing activities in the Licensed Territory of the Licensed Product for use outside of the Licensed Territory pursuant to Karunas Retained Rights, in each such case by Karuna or any of its Affiliates or licensees (other than Zai or its Affiliates, Sublicensees or Subcontractors); (b) the gross negligence, illegal conduct or willful misconduct of Karuna or any of its Affiliates or licensees (other than Zai), or (c) Karunas breach of any of its representations, warranties or covenants made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement; in each case of clauses (a) through (c) above, except to the extent Losses arise from, are based on, or result from any activity or occurrence for which Zai is obligated to indemnify the Karuna Indemnitees under Section 11.1.
11.3. Defined Indemnification Terms. Either of the Zai Indemnitee or the Karuna Indemnitee shall be an Indemnitee for the purpose of this ARTICLE 11, and the Party that is obligated to indemnify the Indemnitee under Section 11.1 or Section 11.2 shall be the Indemnifying Party.
11.4. Defense. If any such Claims are made, the Indemnitee shall be defended at the Indemnifying Partys sole expense by counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnitee; provided that the Indemnitee may, at its own expense, also be represented by counsel of its own choosing. The Indemnifying Party shall have the sole right to control the defense of any such Claim, subject to the terms of this ARTICLE 11.
11.5. Settlement. The Indemnifying Party may settle any such Claim or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnitee but without the consent of the Indemnitee where the only liability to the Indemnitee is the payment of money and the Indemnifying Party makes such payment, without admission of any wrongdoing or fault of the Indemnitee, or (b) in all other cases, only with the prior written consent of the Indemnitee, such consent not to be unreasonably withheld or delayed.
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11.6. Notice. The Indemnitee shall notify the Indemnifying Party promptly of any Claim with respect to which it seeks indemnification under Sections 11.1 or 11.2 and shall reasonably cooperate with all reasonable requests of the Indemnifying Party with respect thereto.
11.7. Permission by Indemnifying Party. The Indemnitee may not settle any such Claim or otherwise consent to an adverse judgment in any such Claim or make any admission as to liability or fault without the express written permission of the Indemnifying Party.
11.8. Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least [***] prior to such Partys decision or receipt of notice from the insurance company, as applicable, with respect to the cancellation, non-renewal or material decrease in the coverage level of such insurance. It is understood that such insurance shall not be construed to create a limit of either Partys liability. Zai shall impose substantially identical obligations on its Affiliates (to the extent not named insureds under Zais coverages) and Sublicensees.
11.9. LIMITATION OF LIABILITY. SUBJECT TO AND WITHOUT LIMITING (A) THE INDEMNIFICATION OBLIGATIONS OF EACH PARTY WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTIONS 11.1 OR 11.2, (B) LIABILITY AS A RESULT OF A BREACH OF ARTICLE 9 OR (C) LIABILITY FOR BREACH OF COVENANTS UNDER SECTION 2.9, NEITHER PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, MULTIPLIED OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS (EVEN IF DEEMED DIRECT DAMAGES) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT.
11.10. No Third Party Beneficiary Rights. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights to any Third Party (including any Third Party beneficiary rights).
ARTICLE 12
INTELLECTUAL PROPERTY
12.1. Ownership. Subject to the license grants under this Agreement, as between the Parties, Karuna shall own and retain all right, title and interest in and to all Product Inventions (and any intellectual property associated therewith), and Zai shall own and retain all right, title and interest in and to all Zai Inventions (and any intellectual property associated therewith). Inventorship shall be determined in accordance with U.S. patent laws.
12.2. Disclosure of Inventions. Zai shall promptly disclose to Karuna in writing all Inventions created, conceived, developed or reduced to practice under this Agreement by or on behalf of Zai or its Affiliates. Zai, for itself and on behalf of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign) to Karuna all its right, title and interest in and to any Product Inventions. Zai will cooperate, and will cause the foregoing persons and entities to cooperate, with Karuna to effectuate and perfect the foregoing ownership, including by promptly executing and recording assignments and other documents consistent with such ownership. For clarity, all Product Inventions assigned by Zai to Karuna shall be included in the Licensed Technology and licensed back to Zai under the terms and conditions of this Agreement, but Licensed Patents claiming such Product Inventions shall not be included in Valid Claim to determine Royalty Term.
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12.3. Patent Prosecution.
(a) Licensed Patents in the Licensed Territory. Karuna shall have the first right, but not the obligation, to conduct Patent Prosecution of the Licensed Patents in the Licensed Territory at its sole cost and expense. Karuna shall consult with Zai and keep Zai reasonably informed of the Patent Prosecution of the Licensed Patents in the Licensed Territory and shall provide Zai with all material correspondence received from any patent authority in the Licensed Territory in connection therewith. In addition, Karuna shall provide Zai with drafts of all proposed material filings and correspondence to any patent authority in the Licensed Territory in connection with the Patent Prosecution of the Licensed Patents for Zais review and comment prior to the submission of such proposed filings and correspondence. Karuna shall consider in good faith Zais comments on such Patent Prosecution but shall have final decision-making authority under this Section 12.3(a). Further, Karuna shall notify Zai of any decision to cease Patent Prosecution of any Licensed Patent in the Licensed Territory at least [***] before any due date for filing, payment or other action to avoid loss of rights, in which case Zai shall have the right to continue the Patent Prosecution of such Licensed Patent at Zais discretion and expense. If Zai decides to take over Patent Prosecution of a Licensed Patent in such Region(s) in the Licensed Territory, then Karuna shall promptly deliver to Zai copies of all necessary files related to such Licensed Patent in such Region(s) in the Licensed Territory and shall take all actions and execute all documents reasonably necessary for Zai to assume such responsibility. For the avoidance of doubt, Zais assumption of responsibility for Patent Prosecution of any Licensed Patent in any Region(s) in the Licensed Territory pursuant to this Section 12.3(a) shall not change the Parties respective ownership rights with respect to such Licensed Patent.
(b) Zai Patents. Zai shall, at its sole cost and expense, (i) have the sole right, but not the obligation, in the Licensed Territory to conduct the Patent Prosecution and maintenance of any Zai Patents; and (ii) have the first right, but not the obligation, outside the Licensed Territory, to conduct the Patent Prosecution and maintenance of any Zai Patents that are used by a Party or its Affiliates in the Exploitation of the Licensed Product, if any (Zai Implemented Patents). Zai shall keep Karuna reasonably informed of the status of all actions taken, including its plans to enter into national phase for PCT applications of Zai Implemented Patent in any country outside the Licensed Territory, and shall consider in good faith Karunas recommendations with respect to the Zai Implemented Patents prosecuted by Zai in the PCT stage or outside the Territory. Further, Zai shall notify Karuna of any decision to cease Patent Prosecution or maintenance of any Zai Implemented Patent outside the Licensed Territory (including any decision of not entering into national phase in any country outside the Licensed Territory) at least [***] before any due date for filing, payment or other action to avoid loss of rights, in which case Karuna shall have the right, but not the obligation, to continue the Patent Prosecution or maintenance of such Zai Implemented Patent outside the Licensed Territory (including entering into national phase in any country outside the Licensed Territory that Zai has decided not to enter) at Karunas discretion and expense. If Karuna decides to take over Patent Prosecution or maintenance of a Zai Implemented Patent outside the Licensed Territory, then Zai shall promptly deliver to Karuna copies of all necessary files related to such Zai Implemented Patent outside the Licensed Territory and shall take all actions and execute all documents reasonably necessary for Karuna to assume such responsibility. For the avoidance of doubt, Karunas assumption of responsibility for Patent Prosecution or maintenance of any Zai Implemented Patent outside the Territory pursuant to this Section 12.3(b) shall not change the Parties respective ownership rights with respect to such Zai Implemented Patent.
12.4. Enforcement.
(a) Product Infringement.
(i) Each Party shall notify the other within [***] of becoming aware of any alleged or threatened infringement by a Third Party of any of the Licensed Patents in the Licensed Territory, by commercializing (or seeking Regulatory Approval to commercialize) the Licensed Product or any other product containing the Compound in the Field in the Licensed Territory, and any related declaratory judgment, opposition, or similar action by a Third Party alleging the invalidity, unenforceability or non-infringement of any Licensed Patent in the Licensed Territory, in each case, within the scope of the license grants in Section 2.1 (collectively Product Infringement).
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(ii) Zai shall have the first right to bring and control any legal action in connection with such Product Infringement in the Licensed Territory at its own expense as it reasonably determines appropriate, provided that Karuna may, [***], elect to be represented by its own counsel and participate in such legal action. Notwithstanding the foregoing, Zai shall not settle or consent to entry of any judgment that would have a material adverse effect on the Licensed Product or any Licensed Patent without Karunas prior written consent. If Zai does not bring such legal action prior to the earlier of: (A) [***] following the receipt or delivery of the notice under Section 12.4(a)(i), or (B) [***] before the deadline, if any, set forth in the Applicable Laws for the filing of such actions, or discontinues the prosecution of any such action after filing without abating such infringement, Karuna shall have the right to bring and control any legal action in connection with such Product Infringement at its own expense as it reasonably determines appropriate.
(b) Non-Product Infringement. Karuna shall have the exclusive right, but not the obligation, to bring and control any legal action in connection with any alleged or threatened infringement by a Third Party of any Licensed Patent that is not a Product Infringement, and any related declaratory judgment, opposition, or similar action by a Third Party alleging the invalidity, unenforceability or non-infringement of such Licensed Patent, at its own expense as it reasonably determines appropriate.
(c) Enforcement of Zai Patents. Karuna shall have the first right, but not the obligation, to bring and control any legal action in connection with any alleged or threatened infringement by a Third Party of any of the Zai Implemented Patents, which infringement takes place outside the Licensed Territory by commercializing (or seeking Regulatory Approval to commercialize) the Licensed Product or any other product containing the Compound in the Field outside the Licensed Territory, and any related declaratory judgment, opposition, or similar action by a Third Party alleging the invalidity, unenforceability or non-infringement of any of the Zai Implemented Patents outside the Licensed Territory, at its own expense as it reasonably determines appropriate, in each case within the scope of the license grants in Section 2.2. Notwithstanding the foregoing, Karuna shall not settle or consent to entry of any judgment that would have a material adverse effect on any Zai Implemented Patent without Zais prior written consent. If Karuna does not bring such legal action prior to the earlier of: (i) [***] following receipt or delivery of notice between the Parties regarding such alleged infringement, or (ii) [***] before the deadline, if any, set forth in the Applicable Laws for the filing of such actions, or discontinues the prosecution of any such action after filing without abating such infringement, Zai shall have the right to bring and control any legal action in connection with infringement at its own expense as it reasonably determines appropriate. Except as otherwise provided under this Section 12.4(c), Zai shall have the exclusive right, but not the obligation, to bring and control any legal action in connection with any alleged or threatened infringement by a Third Party of any of the Zai Patents, and any related declaratory judgment, opposition, or similar action by a Third Party alleging the invalidity, unenforceability or non-infringement of any of the Zai Patents anywhere in the world, at its own expense as it reasonably determines appropriate.
(d) Coordination. At the request of the Party bringing an action related to Product Infringement or otherwise as described in this Section 12.4, the other Party shall provide reasonable assistance in connection therewith, including by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required by Applicable Laws to pursue such action, at each such Partys sole cost and expense. In connection with an action related to Product Infringement or otherwise as described in this Section 12.4, the Party bringing the action shall not enter into any settlement admitting the invalidity or non-infringement of, or otherwise impairing the other Partys rights in the Licensed Patents or Zai Patents, as applicable, without the prior written consent of the other Party (which consent shall not be unreasonably delayed, withheld or conditioned). The enforcing Party shall keep the non-enforcing Party reasonably informed of the status of any action it brought in connection with such Product Infringement or otherwise as described in this Section 12.4. The non-enforcing Party shall be entitled to attend any substantive meetings, hearings, or other proceedings related to any such action pursued by the enforcing Party. The enforcing Party shall provide the non-enforcing Party with copies of all pleadings and other documents to be filed with the court reasonably in advance and shall consider in good faith reasonable and timely input from the non-enforcing Party during the course of the action.
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(e) Recoveries. Any recoveries resulting from enforcement action relating to a claim of Product Infringement or otherwise as described in this Section 12.4 shall be first applied against payment of the enforcing Partys costs and expenses in connection therewith and then the non-enforcing Partys costs and expenses in connection therewith. Any such recoveries in excess of such costs and expenses shall [***].
12.5. Defense.
(a) Each Party shall notify the other in writing of any allegations it receives from a Third Party that the Exploitation of the Compound or Licensed Product in the Field in the Licensed Territory or any embodiment of any technology or intellectual property licensed by the other Party under this Agreement infringes the intellectual property rights of such Third Party. Such notice shall be provided promptly, but in no event after more than [***] following receipt of such allegations. Such written notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action and may, if appropriate, agree on and enter into a common interest agreement wherein the Parties agree to their shared, mutual interest in the outcome of such potential dispute. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties.
(b) As between the Parties, Zai shall have the first right, but not the obligation to control and be solely responsible for the defense of any such suit against Zai, at Zais sole cost and expense; provided, however, Zai shall not enter into any compromise or settlement relating to such suit that (i) admits the invalidity or unenforceability of any Licensed Patents; or (ii) requires abandonment of any Licensed Patents; or (iii) contemplates payment or other action by Karuna or has a material adverse effect on Karunas business, in all cases ((i) through (iii)), without obtaining the prior written consent of Karuna (which consent shall not be unreasonably delayed, withheld or conditioned).
(c) If Zai decides not to bring such legal action subject to its first right, it shall so inform Karuna promptly and Karuna shall have the right, but not the obligation, to bring and control any such legal action in connection with such infringement in the Licensed Territory at its own expense as it reasonably determines appropriate; provided, however, Karuna shall not enter into any compromise or settlement relating to such suit that (i) admits the invalidity or unenforceability of any Licensed Patents; or (ii) requires abandonment of any Licensed Patents; or (iii) contemplates payment or other action by Zai or has a material adverse effect on Zais business, in all cases ((i) through (iii)), without obtaining the prior written consent of Zai (which consent shall not be unreasonably delayed, withheld or conditioned).
(d) Upon the defending Partys request and at the defending Partys expense, the non-defending Party shall provide reasonable assistance to the defending Party for such defense and shall join such suit if deemed a necessary party. If the non-defending Party does not join such suit, the defending Party shall keep the non-defending Party reasonably informed of the status of such suit. The non-defending Party shall be entitled to attend any substantive meetings, hearings, or other proceedings related to such suit. The defending Party shall provide the non-defending Party with copies of all pleadings and other documents to be filed with the court reasonably in advance and shall consider in good faith reasonable and timely input from the non-defending Party during the course of the suit.
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12.6. Patent Marking. Zai agrees to mark, and have its Affiliates and Sublicensees mark, all patented Licensed Product they sell or distribute pursuant to this Agreement in accordance with the applicable patent statutes or regulations in the Regions of sale thereof.
12.7. Bankruptcy Protection. All licenses granted by one Party to the other Party under this Agreement are and shall otherwise be deemed to be for purposes of Section 365(n) of Title 11, United States Code or any applicable foreign equivalent laws (the Bankruptcy Code) licenses of rights to intellectual property as defined in Section 101 of the Bankruptcy Code. Each Party, as the licensee, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. To the extent permitted under Applicable Law, upon the bankruptcy of a Party, the other Party shall further be entitled to a complete duplicate of, or complete access to, any such intellectual property, and such, if not already in its possession, shall be promptly delivered to such other Party, unless the bankruptcy Party elects to continue, and continues, to perform all of its obligations under this Agreement.
ARTICLE 13
TERMS AND TERMINATION
13.1. Term and Expiration.
(a) Term. The term of this Agreement shall be effective as of the Effective Date, and shall continue in effect until the expiration of the last Royalty Term with respect to for all Licensed Product in each Region in the Licensed Territory (the Term, and the date of such expiration with respect to such Region, the Expiration Date). Following the Expiration Date, [***].
(b) Expiration of Royalty Term. On a Region-by-Region and Licensed Product-by-Licensed Product basis, upon the expiration of the Royalty Term for a given Licensed Product in a given Region, the licenses granted by Karuna to Zai under Section 2.1 of this Agreement in such Region with respect to the Licensed Product in the Field shall become fully paid-up, non-exclusive, perpetual, irrevocable and sublicenseable in multiple tiers.
13.2. Termination for Convenience. This Agreement may be terminated by Zai at any time for convenience upon [***] advance written notice to Karuna.
13.3. Termination for Material Breach. This Agreement may be terminated in its entirety, at any time during the Term upon [***] (or [***] with respect to any payment breach) written notice by either Party if the other Party is in material breach of this Agreement and, if such breach is curable, such breach has not been cured within [***] (or [***] with respect to any payment breach) of such written notice. Notwithstanding the foregoing, if the alleged breaching Party disputes the existence or materiality of the alleged breach, the other Party shall not have the right to terminate this Agreement unless and until it is determined in accordance with ARTICLE 14 that the alleged breaching Party has materially breached this Agreement and such breaching Party fails to cure such breach within [***] (or [***] with respect to any payment breach) after such determination.
13.4. Termination for Insolvency. Each Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (a) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization under the Chapter 7 of the United States of Bankruptcy Code or other similar Applicable Law or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (b) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within [***] of its filing, or (c) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.
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13.5. Termination for Patent Challenge. Except to the extent the following is unenforceable under the laws of a particular jurisdiction, Karuna may terminate this Agreement in its entirety upon [***] written notice to Zai if Zai or its Affiliates or Sublicensees commences a legal, administrative or other action challenging the validity, enforceability or scope of any Licensed Patent anywhere in the world, unless (a) such action is withdrawn during such [***] period or, (b) if such action is commenced by a Sublicensee, Zai terminates its sublicense during such [***] period; provided however that Karuna shall not have the right to terminate this Agreement under this Section 13.5 if such action (i) is made as a defense against any claim, action or proceeding with respect to infringement of a Licensed Patent asserted against Zai or its Affiliate or Sublicensee; or (ii) is a legal or administrative proceeding derived from a bona fide inventorship dispute or an argument to distinguish the Product Invention from other inventions in the ordinary course of patent prosecution.
13.6. Termination by Mutual Agreement. This Agreement may be terminated by the Parties mutual written agreement.
13.7. Election to Terminate. If either Party has the right to terminate under Sections 13.3 through 13.5, it may at its sole option, elect either to (a) terminate this Agreement and pursue any legal or equitable remedy available to it, or (b) maintain this Agreement in effect and pursue any legal or equitable remedy available to it.
13.8. Effects of Termination.
(a) Upon the termination of this Agreement for any reason, unless otherwise provided in this Section 13.8, all rights and licenses granted to each Party herein shall immediately terminate, and all sublicenses of such rights and licenses shall also terminate. Upon termination of this Agreement, [***].
(b) Upon termination of this Agreement for any reason, the following additional provisions shall apply:
(i) Reversion of Rights to Karuna. Any rights and licenses with respect to the Licensed Product granted to Zai under this Agreement shall immediately terminate, and all such rights shall revert back to Karuna. In addition, the licenses granted by Zai to Karuna pursuant to Section 2.2 shall continue and become exclusive with respect to the Licensed Territory, and shall automatically be extended to include Exploitation of the Licensed Product in the Field in the Licensed Territory, provided that, if this Agreement is terminated by Zai pursuant to Section 13.3, such license shall only be granted by Zai upon agreement by the Parties on a reasonable reversion royalty payment to Zai, in which case, Clauses (ii) through (v) below shall apply only after the Parties agreement on such reversion royalty.
(ii) Regulatory Materials; Data. Zai shall, and shall cause its Affiliates and Sublicensees to, [***], to the maximum extent permitted by Applicable Laws at the time of any such termination to promptly (A) assign all Regulatory Submissions and Regulatory Approvals and pricing and reimbursement approvals of Licensed Product to Karuna, and (B) assign all data generated by or on behalf of Zai or its designee while conducting Development or Commercialization activities under this Agreement to Karuna or its designee, including non-clinical and clinical studies conducted by or on behalf of Zai on Licensed Product and all pharmacovigilance data (including all Adverse Event database information) on Licensed Product.
(iii) Trademarks. Zai shall, and shall cause its Affiliates and Sublicensees, to promptly transfer and assign to Karuna or its designee, [***], all Product Marks (excluding the corporate name and logo of Zai, its Affiliates and Sublicensees).
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(iv) Transition Assistance. Zai shall, and shall cause its Affiliates and Sublicensees, to provide reasonable administrative assistance, [***], as may be reasonably necessary or useful for Karuna or its designee to commence or continue Developing or Commercializing Licensed Product in the Licensed Territory, including transferring or amending as appropriate, upon request of Karuna, any agreements or arrangements with Third Party to Develop, Manufacture and Commercialize the Licensed Product in the Licensed Territory. To the extent that any such contract between Zai and a Third Party is not assignable to Karuna or its designee, then Zai shall reasonably cooperate with Karuna to arrange to continue to and provide such services from such entity (for clarity, Karuna shall be responsible for paying the cost of such services), including, where applicable, continue to supply the Licensed Product in the Field in the Licensed Territory to Karuna or its designee for a reasonable period of time (which period shall not exceed [***]) to ensure a smooth transitioning and continuous operation of any Development, Manufacture and Commercialization activities for the Licensed Product in the Field in the Licensed Territory.
(v) Ongoing Clinical Trial. If at the time of such termination, any Clinical Trials for the Licensed Product are being conducted by or on behalf of Zai, then, at Karunas election on a Clinical Trial-by-Clinical Trial basis: (1) Zai shall, and shall cause its Affiliates and Sublicensees to, (A) fully cooperate with Karuna to transfer the conduct of all such Clinical Trial to Karuna or its designee, or (B) continue to conduct such Clinical Trials for so long as necessary to enable such transfer to be completed without interruption of any such Clinical Trials but no more than [***], and in each case of (A) and (B), [***], unless this Agreement is terminated by Zai pursuant to Section 13.3, in which case Karuna shall be responsible for all such costs; and (2) Zai shall, and shall cause its Affiliates and Sublicensees to, [***], orderly wind down the conduct of any such Clinical Trial which is not assumed by Karuna under clause (1).
(vi) Preclinical Studies. In the event that as of the date a notice of termination has been issued Zai is conducting any ongoing preclinical work with respect to the Licensed Product in support of a current Regulatory Approval or future regulatory filings for an Indication that is the subject of ongoing clinical development, including without limitation ongoing stability or toxicology studies of the Licensed Product, Zai agrees to promptly inform Karuna of the status of each preclinical activity and at Karunas election either: (A) terminate such preclinical activity, (B) continue to conduct any such preclinical studies for a period of no more than [***] after the effective date of such termination, or (C) promptly transition to Karuna or its designee such preclinical studies, in each case, [***], unless this Agreement is terminated by Zai pursuant to Section 13.3, in which case Karuna shall be responsible for all such costs.
(vii) Inventory. At Karunas election and request, Zai shall (A) upon Karunas request, transfer to Karuna or its designee all inventory of the Licensed Product provided by Karuna [***] then in possession or control of Zai, its Affiliates or Sublicensees; provided that Karuna shall pay Zai a price equal to [***] or (B) (x) continue to use Commercially Reasonable Efforts to Commercialize all inventory of the Licensed Product then in possession or control of Zai for a period [***] after the effective date of such termination and make the corresponding payments, including any Milestone Payments or royalties to Karuna under this Agreement as though this Agreement had not been terminated and (y) after such for a period [***] after the effective date of such termination, transfer to Karuna or its designee any remaining inventory of the Licensed Product to Karuna or its designee at a price equal to [***].
(viii) Return of Confidential Information. At the Disclosing Partys election, the Receiving Party shall return (at Disclosing Partys expense) or destroy all tangible materials comprising, bearing, or containing any Confidential Information of the Disclosing Party relating to the Licensed Product that are in the Receiving Partys or its Affiliates or Sublicensees possession or control and provide written certification of such destruction (except to the extent any information is the Confidential Information of both Parties or to the extent that the Receiving Party has the continuing right to use the Confidential Information under this Agreement); provided that the Receiving Party may retain one copy of such Confidential Information for its legal archives. Notwithstanding anything to the contrary set forth in this Agreement, the Receiving Party shall not be required to destroy electronic files containing such Confidential Information that are made in the ordinary course of its business information back-up procedures pursuant to its electronic.
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(c) Other Remedies. Termination or expiration of this Agreement for any reason shall not constitute a waiver or release of, or otherwise be deemed to prejudice or adversely affect, any rights, remedies or claims, whether for damages or otherwise, that a Party may have hereunder or that may arise out of or in connection with such termination or expiration.
(d) Termination by Zai Due to Material Breach. Upon the termination of this Agreement by Zai pursuant to Section 13.3, all of the provisions of Section 13.8(b) shall apply, except that [***].
13.9. Survival. Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration. The following provisions shall survive the termination or expiration of this Agreement for any reason: [***].
ARTICLE 14
DISPUTE RESOLUTION
14.1. General. The Parties recognize that a claim, dispute or controversy may arise relating to this Agreement or to the breach, enforcement, interpretation or validity of this Agreement (a Dispute). Any Dispute, including Disputes that may involve the Affiliates of any Party, shall be resolved in accordance with this ARTICLE 14.
14.2. Continuance of Rights and Obligations during Pendency of Dispute Resolution. If there are any Disputes in connection with this Agreement, including Disputes related to termination of this Agreement under ARTICLE 13, all rights and obligations of the Parties shall continue until such time as any Dispute has been resolved in accordance with the provisions of this ARTICLE 14.
14.3. Escalation. Any Dispute shall be referred to the Executive Officers for attempted resolution by notice served pursuant to Section 15.5. In the event the Executive Officers are unable to resolve such Dispute within [***] of such Dispute being referred to them, then, upon the written request of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 14.4.
14.4. Arbitration.
(a) If the Parties fail to resolve the Dispute through escalation to the Executive Officers under Section 14.3, and a Party desires to pursue resolution of the Dispute, the Dispute shall be submitted by either Party for final resolution by arbitration under the Rules of Arbitration of the International Chamber of Commerce (ICC Rules), excepted as modified herein. Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this agreement to arbitrate shall be finally settled by the arbitral tribunal. The arbitration shall be conducted by a tribunal of [***] arbitrators, each with at least [***] of pharmaceutical industry experience and independent of both Parties. An arbitrator shall be deemed to meet this qualification unless a Party objects within [***] after the arbitrator is nominated. Within [***] after initiation of arbitration, each Party shall nominate one (1) arbitrator and the two (2) Party-nominated arbitrators shall nominate a third arbitrator, who shall serve as the chairperson of the tribunal, [***] of the second arbitrators appointment (if the two Party-nominated arbitrators cannot agree on the third arbitrator, the third arbitrator shall be appointed by ICC). The seat of arbitration shall be [***] and the language of the proceedings, including all communications, shall be English.
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(b) The Parties agree that any award or decision made by the arbitral tribunal shall be final and binding upon them and may be enforced in the same manner as a judgment or order of a court of competent jurisdiction, and the Parties undertake to carry out any award without delay. The arbitral tribunal shall render its final award or decision within [***] from the date on which the request for arbitration by one of the Parties wishing to have recourse to arbitration is received by the ICC Secretariat. The arbitral tribunal shall resolve the Dispute by applying the provisions of this Agreement and the governing law set forth in Section 15.1.
(c) By agreeing to arbitration, the Parties do not intend to deprive any court of its jurisdiction to issue, at the request of a Party, a pre-arbitral injunction, pre-arbitral attachment or other order to avoid irreparable harm, maintain the status quo, preserve the subject matter of the Dispute, or aid the arbitration proceedings and the enforcement of any award. Without prejudice to such provisional or interim remedies in aid of arbitration as may be available under the jurisdiction of a competent court, the arbitral tribunal shall have full authority to grant provisional or interim remedies and to award damages for the failure of any Party to the dispute to respect the arbitral tribunals order to that effect.
(d) EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY.
(e) Each Party shall bear its own attorneys fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the administrator and the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the administrator and the arbitrators.
(f) Notwithstanding anything in this Section 14.4, in the event of a Dispute with respect to (i) the validity, scope, enforceability or ownership of any Patent or other intellectual property rights, (ii) a matter for which this Agreement assigns decision-making to the Parties or to the JSC or requires the consent of one or both of the Parties, or (iii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory, and such Dispute is not resolved in accordance with Section 14.3, such Dispute shall not be submitted to an arbitration proceeding in accordance with this Section 14.4, and instead shall be resolved, (A) in the case of subsections (ii), in accordance with the respective terms of the relevant provisions, or, (B) in the case of subsection (i) and (iii), unless otherwise agreed by the Parties in writing, via litigation initiated by either Party in a court of competent jurisdiction in any country in which such rights apply.
ARTICLE 15
MISCELLANEOUS
15.1. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, U.S. without reference to any rules of conflict of laws. The United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement and is expressly and entirely excluded.
15.2. Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, pandemics, epidemics or other acts of God or any other deity (or orders of any Governmental Authority related to any of the foregoing), or acts, omissions or delays in acting by any Governmental Authority (each, a Force Majeure Event). The affected Party shall notify the other Party of any Force Majeure Event as soon as reasonably practical, the JSC shall review and discuss any such matter to the extent related to any Clinical Trials in the Licensed Territory, including adjustment to any Development Target and the associated Development Target Deadlines affected by such Force Majeure Event, and the affected Party shall promptly undertake all reasonable efforts necessary to mitigate the impact of such Force Majeure Event.
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15.3. Assignment. Neither Party may assign this Agreement to a Third Party without the other Partys prior written consent (such consent not to be unreasonably withheld); except that (a) subject to Section 2.9, either Party may make such an assignment without the other Partys prior written consent to a successor to substantially all of the business of such Party to which this Agreement relates (whether by merger, spinoff, sale of stock, sale of assets, exclusive license or other transaction), provided that such successor shall agree in writing to comply with the terms of this Agreement, including, in the case of Zai, its obligations under Sections 2.9, 4.2, 5.1(b) and 7.1, and (b) either Party may assign this Agreement to an Affiliate without the other Partys prior written consent for so long as such Affiliate remains an Affiliate of the Party making the assignment. For clarity, each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates and each Party hereby guarantees the performance by its Affiliates of such Partys obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. This Agreement shall inure to the benefit of and be binding on the Parties successors and permitted assignees. Any assignment or transfer in violation of this Section 15.3 shall be null and void and wholly invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning non-transferring Party shall not recognize, nor shall it be required to recognize, such assignment or transfer.
15.4. Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
15.5. Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by internationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
If to Karuna:
Karuna Therapeutics, Inc.
Attention: [***]
99 High Street, 26th Floor
Boston, MA 02110, USA
with a copy to (which shall not constitute notice):
Goodwin Procter LLP
Attention: [***]
100 Northern Avenue
Boston, MA 02210
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If to Zai:
Zai Lab
Attention: [***]
314 Main Street, Suite 04-100
Cambridge, MA 02142, USA
with a copy to (which shall not constitute notice):
Cooley LLP
3175 Hanover Street
Palo Alto, CA 94303-1130
USA
Attention: [***] with an electronic copy to [***]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered; (b) if sent by email, upon electronic confirmation of receipt; (c) on [***] after dispatch if sent by internationally-recognized overnight courier; or (d) on [***] following the date of mailing if sent by mail.
15.6. Entire Agreement; Amendments. This Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. Neither Party is relying on any representation, promise, nor warranty not expressly set forth in this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
15.7. Export Control Regulations. The rights and obligations of the Parties under this Agreement shall be subject in all respects to United States laws and regulations as shall from time to time govern the license and delivery of technology and products abroad, including the United States Foreign Assets Control Regulations, Transaction Control Regulations and Export Control Regulations, as amended, and any successor legislation issued by the applicable Governmental Authorities in the United States. Without limiting the provisions of this Agreement, Zai agrees that, unless prior authorization is obtained from the Office of Export Licensing or other applicable Governmental Authority of the United States, it will not export, re-export, or transship, directly or indirectly, via an Affiliate or a Third Party, to any country, any technical data, information or materials provided to it by Karuna hereto if such export would violate the laws of the United States or the regulations of any Governmental Authority of the United States.
15.8. Headings. The captions to the several Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the Sections of this Agreement.
15.9. Independent Contractors. It is expressly agreed that Karuna and Zai shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Karuna nor Zai shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.
15.10. Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.
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15.11. Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
15.12. Construction. Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words include, includes and including shall be deemed to be followed by the phrase without limitation, (c) the word will shall be construed to have the same meaning and effect as the word shall, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the persons successors and assigns, (f) the words herein, hereof and hereunder, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections, Schedules, or Exhibits shall be construed to refer to Sections, Schedules or Exhibits as described in this Agreement, (h) the word notice means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder agree, consent or approve or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or Section, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term or shall be interpreted in the inclusive sense commonly associated with the term and/or where applicable.
15.13. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Each Party shall be entitled to rely on the delivery of executed facsimile copies of counterpart execution pages of this Agreement and such facsimile copies shall be legally effective to create a valid and binding agreement among the Parties.
15.14. Language. This Agreement is in the English language only, which language shall be controlling in all respects, and all versions hereof in any other language shall be for accommodation only and shall not be binding upon the Parties. All communications and notices to be made or given pursuant to this Agreement, and any dispute proceeding related to or arising hereunder, shall be in the English language. If there is a discrepancy between any translation of this Agreement and this Agreement, this Agreement shall prevail.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
Karuna Therapeutics, Inc. | Zai Lab (Shanghai) Co., Ltd | |||||||
By: | /s/ Steven M. Paul, M.D. |
By: | /s/ Samantha Du | |||||
Name: | Steven M. Paul, M.D. |
Name: | Samantha Du | |||||
Title: | CEO, President & Chairman |
Title: | CEO and Chairperson |
Signature Page to the License Agreement
Schedule 1.23
Compound
KarXT is combination of xanomeline tartrate, a muscarinic agonist developed by Lilly, and trospium chloride, a muscarinic agonist, indicated for treating overactive bladder. Xanomeline has the IUPAC name of 3-(hexyloxy)-4-(1-methyl-1,2,5,6-tetrahydropyridin-3-yl)-1,2,5-thiadiazole tartrate and the structure .. Trospium chloride has the IUPAC name of [(1R,5S)-spiro[8-azoniabicyclo[3.2.1]octane-8,1-azolidin-1-ium]-3-yl] 2-hydroxy-2,2-diphenylacetate chloride and the structure of ..
Schedule 1.42
Existing In-License Agreement
[***]
Schedule 1.43
Claims in the Existing Patent Application
[***]
Schedule 1.58
[***]
Schedule 1.59
[***]
Schedule 1.79
Licensed Patents
[***]
Schedule 2.5
Hong Kong License Terms
[***]
Schedule 2.11
Existing In-License Agreement Terms
[***]
Schedule 4.1
Initial Development Plan
[***]
Schedule 9.3(a)
Initial Press Release
Karuna Therapeutics and Zai Lab Announce Strategic Collaboration for Development, Manufacturing, and Commercialization of KarXT in Greater China
Zai Lab obtains exclusive rights to develop and commercialize KarXT in Greater China
Karuna to receive upfront cash payment of $35 million, up to $152 million in potential near- and long-term development and commercial milestones and other payments, and low-double-digit to high-teens tiered royalties
BOSTON, SHANGHAI and SAN FRANCISCO Nov. 9, 2021 Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced their entry into an exclusive license agreement for the development, manufacturing, and commercialization of KarXT (xanomeline-trospium) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
KarXT is an oral, investigational M1/M4-preferring muscarinic agonist that stimulates receptors in the central nervous system implicated in various psychiatric conditions. KarXT was designed to unlock the therapeutic potential of xanomeline, which demonstrated significant benefits in reducing symptoms of psychosis in Phase 2 studies in schizophrenia and Alzheimers disease, while ameliorating side effects seen in earlier studies. In the Phase 2 EMERGENT-1 trial, KarXT demonstrated clinically meaningful and statistically significant improvements in the primary endpoint of Positive and Negative Syndrome Scale (PANSS) total score, and in key secondary endpoints, including PANSS-positive subscore and PANSS-negative subscore, at week 5, and was generally well-tolerated.
Karuna is evaluating KarXT in late-stage clinical trials for the treatment of schizophrenia and psychosis in Alzheimers disease. The EMERGENT program, the clinical program evaluating KarXT for the treatment of schizophrenia, is underway. The EMERGENT program is comprised of the previously completed Phase 2 EMERGENT-1 trial and four ongoing Phase 3 trials, with data from EMERGENT-2 and EMERGENT-3, the two Phase 3 acute efficacy and safety trials, expected in mid-2022 and in the second half of 2022, respectively. Karuna plans to initiate the Phase 3 ARISE trial evaluating KarXT as an adjunctive treatment for schizophrenia in adults who inadequately respond to atypical antipsychotics in the fourth quarter of 2021. Additionally, Karuna also plans to initiate a Phase 3 program evaluating KarXT for the treatment of psychosis in Alzheimers disease in mid-2022 following encouraging results from the completed Phase 1b healthy elderly volunteer trial, which suggest that potentially therapeutic doses of KarXT can be administered to elderly adults while maintaining a favorable tolerability profile. Zai Lab will work with Karuna to design the optimal strategy to accelerate the development and regulatory timeline of KarXT in Greater China.
Under the terms of the agreement, Karuna will receive a $35 million upfront payment and is eligible to receive up to an additional $80 million in development and regulatory milestones. Karuna is also eligible to receive up to $72 million in sales milestones and low-double-digit to high-teens tiered royalties based on annual net sales of KarXT in Greater China. Zai Lab will fund substantially all development, regulatory, and commercialization activities in Greater China.
We are thrilled to collaborate with Zai Lab, who shares our commitment to bringing transformative medicines to people living with psychiatric conditions globally, said Steve Paul, M.D., chief executive officer, president, and chairman of Karuna Therapeutics. With their proven record of successfully developing and commercializing novel therapies in Greater China, we believe that Zai Lab is the ideal partner to expand the global footprint for KarXT alongside our ongoing efforts in the U.S., with the goal of providing meaningful treatments to millions of people living with mental illness globally.
Our collaboration with Karuna is a significant milestone for Zai Lab, marking the expansion and diversification of our development and commercial portfolio into neuroscience, our fourth therapeutic area, said Samantha Du, Ph.D., founder, chairperson and chief executive officer of Zai Lab. KarXT is well positioned to serve as the anchor asset in our new neuroscience franchise. Zai Labs mission is to deliver innovative medicines to address unmet medical needs of patients, and we look forward to working with Karuna to bring KarXT to patients in need in Greater China as soon as possible.
There is a significant need for new and more effective therapies with improved safety to treat serious psychiatric conditions in Greater China, said Gang Wang, M.D., Director of National Clinical Research Center for Mental Disorders, Dean of Beijing Anding Hospital, Capital Medical University. Currently, more than 8 million people in Greater China are living with schizophrenia, yet fewer than half are receiving treatment, and even fewer are obtaining adequate symptom improvement from current treatment. We believe KarXT has the potential to provide a meaningful new treatment option for many patients living with schizophrenia and other conditions with disabling symptoms of psychosis.
Goldman Sachs & Co. LLC is acting as financial advisor to Karuna Therapeutics.
About KarXT
KarXT (xanomeline-trospium) is an oral, investigational M1/M4-preferring muscarinic acetylcholine receptor agonist in development for the treatment of psychiatric and neurological conditions, including schizophrenia and dementia-related psychosis. KarXT preferentially stimulates muscarinic receptors in the central nervous system implicated in these conditions, as opposed to current antipsychotic medicines, which bind to the D2 dopamine receptor. KarXT has the potential to usher in a new class of treatment for schizophrenia and dementia-related psychosis based on its differentiated mechanism of action.
About Karuna Therapeutics
Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples lives. For more information, please visit www.karunatx.com.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused, innovative, commercial-stage, global biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to impact human health worldwide.
For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.
Karuna Therapeutics Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the potential benefits and results that may be achieved through our collaboration with Zai Lab, our ongoing and planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, and other statements identified by words such as could, expects, intends, may, plans, potential, should, will, would, or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2020. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Zai Lab Forward-Looking Statements
This press release contains statements about future expectations, plans and prospects, including, without limitation, statements relating to the potential, benefits, safety and efficacy of KarXT; the clinical development of KarXT; the potential treatment of schizophrenia and dementia-related psychosis; the potential of Zai Labs commercial business and pipeline programs; the anticipated benefits and potential of Zai Labs collaboration arrangement with Karuna Therapeutics, Inc. and other risks and uncertainties associated with drug development and commercialization. These forward-looking statements may contain words such as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, plan, possible, potential, will, would and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to finance our operations and business initiatives and obtain funding for such activities, (3) our results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Karuna Contact
Investor Relations:
Alexis Smith
+1 (518) 338-8990
asmith@karunatx.com
Zai Lab Contacts
Investor Relations:
Ron Aldridge
+1 (781) 434-8465
ronald.aldridge@zailaboratory.com
Lina Zhang
+86 136 8257 6943
lina.zhang@zailaboratory.com
Media:
Danielle Halstrom
+1 (215) 280-3898
danielle.halstrom@zailaboratory.com /
Xiaoyu Chen
+86 185 0015 5011
xiaoyu.chen@zailaboratory.com
Exhibit 21.1
Subsidiaries of Registrant
Name |
Chinese Name (where applicable) |
Jurisdiction of Incorporation of Organization | ||
Zai Lab (Hong Kong) Limited | 再创医药(香港)有限公司 | Hong Kong | ||
Zai Lab (Shanghai) Co., Ltd. | 再鼎医药(上海)有限公司 | Shanghai | ||
Zai Lab International Trading (Shanghai) Co., Ltd. | 再鼎国际贸易(上海)有限公司 | Shanghai | ||
Zai Lab (Suzhou) Co., Ltd. | 再鼎医药(苏州)有限公司 | Suzhou | ||
Zai Lab Trading (Suzhou) Co., Ltd. | 再鼎医药贸易(苏州)有限公司 | Suzhou | ||
Zai Biopharmaceutical (Suzhou) Co., Ltd | 再创生物医药(苏州)有限公司 | Suzhou | ||
Zai Lab (Aust) Pty., Ltd. | N/A | Australia | ||
Zai Lab (US) LLC | N/A | USA | ||
ZLIP Holding Limited | N/A | Cayman | ||
ZL Capital Limited | N/A | BVI | ||
ZL China Holding Two Limited | N/A | Hong Kong | ||
Zai Auto Immune Limited | N/A | Cayman | ||
Zai Auto Immune (Hong Kong) Limited | N/A | Hong Kong | ||
Zai Anti Infectives Limited | N/A | Cayman | ||
Zai Anti Infectives (Hong Kong) Limited | N/A | Hong Kong | ||
Zai Lab (Taiwan) Limited | 再鼎台湾医药有限公司 | Taiwan |
* | All subsidiaries are wholly owned, directly or indirectly, by Zai Lab Limited. |
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements No. 333-221616, No. 333-239223 and No. 333-258630 on Form S-8 of our reports dated March 1, 2022, relating to the financial statements of Zai Lab Limited and the effectiveness of Zai Lab Limiteds internal control over financial reporting, appearing in this Annual Report on Form 10-K for the year ended December 31, 2021.
/s/ Deloitte Touche Tohmatsu Certified Public Accountants LLP
Shanghai, the Peoples Republic of China
March 1, 2022
Exhibit 31.1
Certification by the Principal Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Samantha (Ying) Du, certify that:
1. I have reviewed this annual report on Form 10-K of Zai Lab Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: March 1, 2022 | /s/ Samantha (Ying) Du | |
Samantha (Ying) Du | ||
Chief Executive Officer | ||
(Principal Executive Officer) |
Exhibit 31.2
Certification by the Principal Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Billy Cho, certify that:
1. I have reviewed this annual report on Form 10-K of Zai Lab Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
Date: March 1, 2022 | /s/ Billy Cho | |
Billy Cho | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
Exhibit 32.1
Certification by the Principal Executive Officer
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the annual report on Form 10-K of Zai Lab Limited (the Company) for the year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Samantha (Ying) Du, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: March 1, 2022 | /s/ Samantha (Ying) Du | |||
Samantha (Ying) Du | ||||
Chief Executive Officer | ||||
(Principal Executive Officer) |
This certification accompanies the Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Zai Lab Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Annual Report on Form 10-K), irrespective of any general incorporation language contained in such filing.
Exhibit 32.2
Certification by the Principal Financial Officer
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the annual report on Form 10-K of Zai Lab Limited (the Company) for the year ended December 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Billy Cho, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Chief Financial Officer |
||||
Date: March 1, 2022 | /s/ Billy Cho | |||
Billy Cho | ||||
Chief Financial Officer | ||||
(Principal Financial and Accounting Officer) |
This certification accompanies the Annual Report on Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Zai Lab Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of this Annual Report on Form 10-K), irrespective of any general incorporation language contained in such filing.