LICENSE AGREEMENT
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. OMITTED INFORMATION HAS BEEN REPLACED WITH ASTERISKS [***]
This LICENSE AGREEMENT (the “Agreement”) is made effective on June 13, 2025 (the “Effective Date”), by and between NextCure, Inc., a Delaware corporation, having a place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇., ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ U.S.A. (“NextCure”) and Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (in Chinese, 海南先声再明医药股份有限公司), a Chinese corporation, having a place of business at ▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇. ▇. China (“Zaiming”).
RECITALS
(A)Zaiming is a biopharmaceutical company based in the People’s Republic of China dedicated to the discovery, development, manufacturing, and commercialization of world-class innovative biotherapeutics for cancer treatment.
(B)NextCure is a biotechnology company based in the United States dedicated to advancing novel therapies for cancer patients.
(C)Zaiming has developed certain proprietary antibody drug conjugate candidates and technologies.
(D)NextCure wishes to obtain a license to Zaiming’s intellectual property directed to such antibody drug conjugates to develop, manufacture, and commercialize therapeutic products as further set forth in this Agreement.
NOW IT IS HEREBY AGREED as follows:
| 1.1 | In this Agreement, the following words and expressions have the following meanings: |
| (a) | “Accounting Standards” means the IFRS (International Financial Reporting Standards) or GAAP or, if not applicable, any similar accounting standard, in each case, as generally and consistently applied throughout the relevant organization. |
| (b) | “ADC” means an antibody drug conjugate chemical entity intended as a human therapeutic and comprising antibody conjugated via a linker to a cytotoxic payload. |
| (c) | “Affiliate” means with respect to a legal entity, any other legal entity that directly or indirectly controls, is controlled by or is under common control with such legal entity; where “control”, and with correlative meanings, “controlled by” and “under common control with”, shall mean: (i) the possession, directly or indirectly, of the power to direct the management or policies of a company or person, whether through the ownership of voting securities, by contract or otherwise; or (ii) the ownership, directly or indirectly, of over 50% of the outstanding voting securities or other ownership interest of a legal entity. |
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| (d) | “Annual Net Sales” means, on a Licensed Product-by-Licensed Product basis, the Net Sales of such Licensed Product in the NextCure Territory calculated on an aggregate basis for a given Calendar Year during the Royalty Term for such Licensed Product. |
| (e) | “Arising IP” means Intellectual Property Rights generated by or on behalf of NextCure or Zaiming or their respective Affiliates or Sublicensees, in each case, in the performance of any activities under this Agreement during the Term. |
| (g) | “Biosimilar Entry” means, with respect to a Licensed Product in a country in the NextCure Territory, the sale of one or more Biosimilar(s) for any of the Indications included in the approved labeling of such Licensed Product in such country in a given Calendar Quarter. |
| (h) | “BLA” means a Biologics License Application submitted to the FDA pursuant to 42 U.S.C. § 262 and 21 C.F.R. Part 601 for purposes of obtaining Regulatory Approval for a new biologic in the United States, or, as context so indicates, any equivalent filing in a country or regulatory jurisdiction other than the United States. |
| (i) | “Business Day” means Monday to Friday (inclusive) except bank or public holidays in Washington, DC, U.S.A. or Beijing, China. |
| (j) | “Calendar Quarter” means the three-month period ending on March 31, June 30, September 30 and December 31 of each Calendar Year, except the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
| (k) | “Calendar Year” means four (4) consecutive Calendar Quarters beginning with the three-month period ending on March 31, except the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs, and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term. |
| (l) | “CDA” means that certain Confidentiality Agreement dated August 30, 2024 by and between Zaiming and NextCure. |
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| (m) | “CDR” means complementarity-determining region defined under the ▇▇▇▇▇ numbering convention described in ▇▇▇▇▇ et al., J. Biol. Chem. 252, 6609-6616 (1977) and ▇▇▇▇▇ et al. Sequences of protein of immunological interest. (1991). |
| (o) | “CMC” means the Chemistry, Manufacturing and Controls portion of the IND or BLA for a biologic product in the United States, Europe, China or equivalent or similar portion of an IND, BLA or Marketing Authorization Application in another regulatory jurisdiction. |
| (p) | “CMO” means a contract manufacturing organization. |
| (q) | “Combination Product” means a Licensed Product whether combined in a single formulation or package with any Other Components, or formulated or packaged separately but required pursuant to approved product labelling to be used with any Other Component and sold together with such Other Component for a single price. |
| (r) | “Commercialization” means any and all activities directed toward obtaining pricing and reimbursement approvals, marketing, promoting, distributing, importing, exporting, selling or offering to sell a pharmaceutical or biologic product, excluding activities directed to Development, Manufacturing, or Medical Affairs, and “Commercialize” and “Commercializing” shall have a corresponding meaning. |
| (s) | “Commercially Reasonable Efforts” means, the efforts and resources that are consistent with the efforts and resources that a reasonable Third Party biopharmaceutical company of the size of, and with the resources available to the relevant Party would typically devote to a pharmaceutical or biologic product of similar market potential at a similar stage in Development or Commercialization, taking into account all relevant factors, including technical, medical, efficacy, safety, manufacturing, and the patent and other proprietary position of the pharmaceutical or biologic product, the competitiveness of the marketplace and the market potential of such products, and the regulatory environment. |
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| (t) | “Common Stock” means the common stock of NextCure which is publicly traded on the Nasdaq stock exchange under the stock symbol NXTC. |
| (v) | “Competing Product” means, (i) with respect to Zaiming Product, any monospecific ADC product, other than the Zaiming Product, that comprises (x) a monospecific antibody targeting CDH6 and (y) any topoisomerase inhibitor as the payload, or (ii) with respect to NextCure Product, any monospecific ADC product, other than the NextCure Product, that comprises a monospecific antibody targeting [***] which antibody has a Composite CDR with at least [***] homology to the Composite CDR of the NextCure Antibody contained in such NextCure Product. |
| (y) | “Control” or “Controlled” means, (i) with respect to any Intellectual Property Right of a Party, that the Party owns or has a license to such Intellectual Property Right (other than pursuant to this Agreement) and has the ability to grant access, a license, or a sublicense to such Intellectual Property Right to any other Party as provided in this Agreement without violating an agreement with or other rights of any Third Party; or (ii) with respect to any materials or other tangible Know-How, the legal authority or right to physical possession of such materials or tangible Know-How, with the right to provide or license such materials or tangible Know-How to the other Party on the terms set forth herein. Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to “Control” any of the foregoing (i)-(ii) that, (x) 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 (or that |
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| merges or consolidates with such Party) after the Effective Date as a result of such Change of Control, unless (A) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Intellectual Property Rights or proprietary rights towards a product, or (B) after the consummation of such Change of Control, such acquired Party or any of its Affiliates uses any such Intellectual Property Rights or proprietary rights towards a product in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases ((A) and (B)), such Intellectual Property Rights or proprietary rights towards a product will be deemed to be “Controlled” by such Party for purposes of this Agreement; or (y) is obtained by a Party from a Third Party after the Effective Date, unless such Party possesses the right to grant such license, sublicense, or other right to such Intellectual Property Rights, or the right to provide or license such materials or tangible Know-How to the other Party on the terms set forth herein, in each case, without being obligated to pay any royalties or other consideration therefor, or the other Party agrees in advance of any grant of rights thereto to pay such royalties or other consideration arising as a result such Party’s or its Affiliate’s or Sublicensee’s use or practice of such Intellectual Property Right or materials or tangible Know-How under this Agreement. |
| (z) | “Cover”, “Covering” or “Covered” means, with respect to a product, technology, process or method, that, in the absence of ownership of, or a license granted under, a Valid Claim, the practice or Exploitation of such product, technology, process or method would infringe such Valid Claim (or, in the case of a Valid Claim that has not yet issued, would infringe such Valid Claim if it were to issue). |
| (aa) | “Data” means any and all scientific, technical and test data pertaining to any Licensed Compound or Licensed Product, including research data, safety data, tolerability data, clinical pharmacology data, CMC data (including analytical and quality control data and stability data), non-clinical data, clinical trial data or submissions made in association with an IND or Marketing Authorization Application with respect to any Licensed Compound or Licensed Product, in each case that is Controlled by a Party. |
| (bb) | “Day” means any period of 24 consecutive hours commencing at 12:01 a.m. Eastern time and concluding at midnight including Business Days, weekends and bank or public holidays. |
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| Territory. The Development Plan shall also set forth in reasonable details any Manufacturing or clinical development of the Zaiming Compound and Zaiming Products, including clinical supply and technology transfer activities, reasonably required of Zaiming that are consistent with the terms of this Agreement. The Development Plan may be updated from time to time through the JSC in accordance with the terms hereof. An initial Development Plan mutually agreed by the Parties is attached to this Agreement as Schedule 1.1(dd). |
| (ee) | “Equity Agreement” means the Common Stock issuance agreement as may be executed by and between the Parties after the Effective Date. |
| (ff) | “Europe” means the countries and territories in Europe, including the United Kingdom, Switzerland, and members of the European Union. |
| (hh) | “FDA” means the United States Food and Drug Administration or any successor agency(ies) or authority thereto having substantially the same function. |
| (ii) | “Field” means all uses in humans. |
| (jj) | “First Commercial Sale” means, with respect to a Licensed Product in a country or region in the NextCure Territory, the first sale to a Third Party of such Licensed Product in such country or region after all Regulatory Approvals required to market and sell the Licensed Product in such country or region have been obtained. |
| (kk) | “GMP” means the current good manufacturing practice requirements and standards for the production of drug and biological products, including, as applicable, FDA regulations as set forth in 21 C.F.R. Parts 210, 211, 600, and 610, and related guidance documents, and as interpreted by relevant ICH guidelines, and the applicable laws in any other jurisdiction corresponding to the foregoing; in each case, as amended from time to time. |
| (ll) | “ICH” means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. |
| (mm) | “IND Application” means an application submitted to a Competent Authority for authorization by the applicable Competent Authority to initiate human clinical trials, including an (i) Investigational New Drug application filed with the US Food and Drug Administration in the United States, (ii) a clinical trial application submitted to the European Medicines Agency of the European Union, (iii) a clinical trial application submitted to the National Medical Products Administration (NMPA) of China, and (iv) any equivalent filing in any other jurisdiction. |
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| particular disease, condition or disorder shall not be a separate Indication; (ii) moving from one line of therapy to another for a particular disease, condition or disorder shall not be considered to be a new Indication (e.g., moving from second line therapy to first line therapy); (iii) an Indication for a product includes all uses (e.g., prophylactic and therapeutic uses) for the relevant disease, condition or disorder for all patient populations (e.g., pediatric and adult uses) irrespective of different formulation(s), dosage forms, dosage strengths, or delivery system(s) used; and (iv) obtaining a label expansion for use of a product in combination with another product in the same disease, condition or disorder, in each case, shall not be considered to be a new Indication. |
| (oo) | “Initiation” means for a clinical trial the first dosing of the first patient (or subject in the case of a Phase 1 Clinical Trial) for such trial. |
| (pp) | “Intellectual Property Rights” means all Patent Rights, rights to inventions, utility models, copyright and related rights, trademarks, trade names and domain names, rights in goodwill or to sue for passing off, rights in designs, rights in computer software, database rights, rights in confidential information (including Know-How, unpatented technical information, and trade secrets) and any other intellectual property rights, in each case, whether registered or unregistered and including all applications (or rights to apply) for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection that may now or in the future subsist in any part of the world. |
| (qq) | “Know-How” means any data, results, and information of any type whatsoever, in any tangible or intangible form, including trade secrets, practices, techniques, methods, processes, inventions, discoveries, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, clinical and non-clinical study reports, clinical and non-clinical data, regulatory filings and regulatory submission documents and summaries, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures and any other know-how, and any physical embodiments of any of the foregoing. |
| (rr) | “Knowledge” means, with respect to a Party, the actual knowledge of such Party’s executive officers and their direct reports, after due inquiry, as applicable. |
| (ss) | “Licensed Compound” means any Zaiming Compound or any NextCure Compound. |
| (tt) | “Licensed Product” means any Zaiming Product or NextCure Product. |
| (uu) | “MAA” means a Marketing Authorization Application submitted to EMA under centralized procedure or other Competent Authority in any country in Europe for the purpose of obtaining approval for the marketing of a Licensed Product for the countries in Europe or the country in Europe where such Competent Authority is located, as applicable. |
| (vv) | “Major Market Country” means the United States, United Kingdom, France, Germany, Spain, Italy and Japan. |
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| (ww) | “Manufacture” means activities directed to manufacturing, processing, packaging, labelling, filling, finishing, assembly, shipping, storage, or freight of any pharmaceutical or biologic product (or any components or process steps involving such 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 such 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, Medical Affairs, or Commercialization, and “Manufacturing” shall have a corresponding meaning. |
| (yy) | “Medical Affairs” means activities conducted by a Party’s 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 Party’s medical affairs (or equivalent) departments. |
| (zz) | “Net Sales” means the gross amounts invoiced and received by or on behalf of a Selling Entity for the sale of Licensed Products to a Third Party in bona fide arm’s length transactions during the relevant Royalty Term less the following specified deductions (which amounts shall only be deducted once without duplication), in each case, to the extent actually allowed, applied, or taken with respect to sales of such Licensed Product and not otherwise recovered by or reimbursed to the Selling Entity, including estimated amounts periodically reconciled to actual charges for the applicable period, in each case consistently applied on a country-by-country basis in accordance with the Selling Party’s Accounting Standards: |
| (i) | normal cash, quantity and trade discounts actually granted in relation to such Licensed Products; |
| (ii) | rebates, chargebacks, and discounts (or equivalent thereof) managed health care organizations, group purchasing organizations, insurers, pharmacy benefit managers (or equivalent thereof), specialty pharmacy providers, governmental authorities, or their agencies or purchasers, reimbursers, or trade customers, as well as amounts owed to patients through co-pay assistance cards or similar forms of rebate, in each case, to the extent directly related to the purchase or prescription of such Licensed Products; |
| (iii) | compulsory or negotiated payments and cash rebates or other expenditures to governmental authorities (or designated beneficiaries |
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| thereof) in the context of any national or local health insurance programs or similar programs; including, but not limited to, pay-for-performance agreements, risk sharing agreements as well as government levied fees as a result of the U.S. Patient Protection and Affordable Care Act; |
| (iv) | any credits or refunds actually given or amounts actually repaid by a Selling Entity for actual rejected, recalled or returned Licensed Products or because of retroactive price reductions; |
| (v) | actual and reasonable freight, transportation, postage, insurance and handling expenses for the Licensed Products in the NextCure Territory in connection with the sale, transportation, delivery or return of such Licensed Products; |
| (vi) | any tax, duties, levies, and other compulsory governmental charges imposed by applicable law on the Selling Entity on the sale to a Third Party of the Licensed Products (including VAT or excise duties, tariffs, but not including income or franchise taxes of any kind whatsoever); and |
| (vii) | amounts written off by reason of uncollectible debt if and when actually written off or allowed; provided, however, that the Selling Entity will use Commercially Reasonable Efforts to collect any such amount and any such amount subsequently collected will be included in Net Sales. |
All of the above deductions shall be determined from the books and records of NextCure, its Affiliates or Sublicensees maintained in accordance with such party’s Accounting Standards. For purposes of determining Net Sales, a Licensed Product shall be deemed to be sold when invoiced.
With respect to the calculation of Net Sales:
| (A) | sales between or among NextCure or its Affiliates or Sublicensees for resale shall be disregarded for purposes of calculating Net Sales, but the subsequent resale of such Licensed Product to a Third Party shall be included within the computation of Net Sales; and |
| (B) | transfer or supply of the Licensed Products in reasonable quantities in connection with clinical trials, compassionate use or expanded or early access programs, indigent programs, promotional sampling or technology transfer activities shall be disregarded for purposes of calculating Net Sales. |
In the case of any Combination Product sold in a given country in the NextCure Territory, Net Sales for the purpose of determining royalties and sales milestones of the Combination Product in such country will be calculated by multiplying the actual Net Sales of such Combination Product by the fraction A/(A+B), where A is the invoice price of the Licensed Product if sold separately in the same Indication in such country, and B is the total invoice price of the Other Components in the Combination Product, if sold separately in the same Indication in such country.
If, on a country-by-country basis, the Licensed Product is sold separately in the same Indication in a country, but the Other Components in the Combination Product are not
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sold separately in the same Indication in such country, then Net Sales for the purpose of determining royalties and sales milestones of the Combination Product for such country will be calculated by multiplying the actual Net Sales of the Combination Product by the fraction A/C, where A is the invoice price of the Licensed Product if sold separately in the same Indication in such country, and C is the invoice price of the Combination Product in such country; provided that the maximum value of the fraction A/C is one (1). As an example, for illustrative purposes, if NextCure is required, whether by a Competent Authority or for other commercial reasons, to sell the Combination Product below fair market value such that the invoice price of the Licensed Product is greater than the price of the Combination Product, the Net Sales on such Combination Product will be treated as if the invoice price of the Licensed Product is equal to the invoice price of the Combination Product and Net Sales of such Combination Product will be treated the same as the Net Sales for the Licensed Product sold separately.
If, on a country-by-country basis, the Licensed Product in the Combination Product is not sold separately in the same Indication in such country, but the Other Components included in the Combination Product are sold separately in the same Indication in such country, then Net Sales for the purpose of determining royalties and sales milestones of the Combination Product for such country will be calculated by multiplying the actual Net Sales of the Combination Product by the fraction (C-B)/C, where B is the invoice price of the Other Components included in such Combination Product if sold separately in the same Indication in such country, and C is the invoice price of the Combination Product in such country; provided that the maximum value of the fraction (C-B)/C is one (1).
In the case where no clause above is applicable, the Parties shall determine Net Sales for such Combination Product in such country by reasonable mutual agreement based on the relative contribution of the single active ingredient in the original Licensed Product and the Other Component in the combination Licensed Product.
In any event, NextCure, its Affiliates and Sublicensees shall not sell any Combination Product in such a manner as to disproportionately discount the selling price of the Licensed Product as compared with the weighted-average discount applied to the Other Component(s) in the Combination Product, as a percent of the respective list prices (or if not available, a good faith estimate thereof) of such Other Component and the Licensed Product prior to applying the discount.
| (aaa) | “NextCure Antibody” means one or more humanized monospecific antibodies Controlled by NextCure that target [***] (also commonly known as “[***]”). For clarity, NextCure Antibodies do not include any monospecific antibody Controlled by Zaiming or its Affiliate that targets [***]. |
| (bbb) | “NextCure Compound” means (i) any monospecific ADC compound comprising a NextCure Antibody combined with the Zaiming ADC Platform Technology and Developed under the NextCure Program pursuant to this Agreement, and (ii) any modification and improvement of such ADC compound in (i) generated under this Agreement. |
| (ccc) | “NextCure IP” means, (i) with respect to the Zaiming Compound and Zaiming Products, all NextCure Arising IP and NextCure’s interests in the Joint Arising IP that are (x) owned or Controlled by NextCure or any of its Affiliates as of the Effective Date or during the Term, and (y) necessary or reasonably useful to Exploit the Zaiming Compound and Zaiming Products in the Field in the |
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| Zaiming Territory (or with respect to non-clinical Development and Manufacturing, worldwide); and (ii) with respect to the NextCure Compounds and NextCure Products, all Patent Rights and Know-How, that are owned or Controlled by NextCure or its Affiliate as of the Effective Date or during the Term that are necessary or reasonably useful to Exploit the NextCure Compounds and NextCure Products in the Field in the Zaiming Territory (or with respect to non-clinical Development and Manufacturing, worldwide). All Patent Rights and Know-How within NextCure Arising IP and its interest in the Joint Arising IP, in each case, that satisfy the foregoing criteria, shall be included as NextCure IP. |
| (ddd) | “NextCure Patent Rights” means any Patent Rights within NextCure IP. All NextCure Patent Rights as of the Effective Date are set forth on Schedule 1.1(ddd). |
| (eee) | “NextCure Product” means any therapeutic product containing a NextCure Compound, whether alone or in combination with one or more Other Components, in any formulation or dosage form. |
| (ggg) | “NextCure Territory” means worldwide other than the Zaiming Territory. |
| (hhh) | “Other Component” means any therapeutically active drug or biologic that is not a Zaiming Compound or a NextCure Compound. |
| (iii) | “Parties” means ▇▇▇▇▇▇▇ and NextCure and “Party” means either of them. |
| (jjj) | “Patent Rights” means (i) any national, regional or international patent or patent application, including any provisional patent application, (ii) any patent application filed either from such a patent, patent application or provisional application or from an application claiming priority from any of these, including any divisional, continuation, continuation-in-part, provisional, converted provisional, and continued prosecution application, (iii) any patent that has issued or in the future issues from any of the foregoing patent applications ((i) and (ii)), including any utility model, ▇▇▇▇▇ patent, design patent and certificate of invention, (iv) any extension or restoration by existing or future extension or restoration mechanisms, including any revalidation, reissue, re-examination and extension (including any supplementary protection certificate and the like) of any of the foregoing patents or patent applications ((i), (ii) and (iii)), and (v) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent application or patent. |
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| other country or region, the equivalent of such a clinical trial in such other country or region. |
| (lll) | “Phase 2 Clinical Trial” means a clinical trial in which a Licensed Product is administered to human subjects, the principal purpose of which is to identify any common short-term side effects and risks associated with the Licensed Product and to evaluate Licensed Product’s safety and efficacy in the proposed therapeutic indication, in a manner 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. |
| (mmm) | “Phase 3 Clinical Trial” means a clinical trial in which a Licensed Product is administered to human subjects, that is (i) designated to produce statistically meaningful data to establish the safety and effectiveness of the Licensed Product for its intended use under specified conditions of use; in a manner sufficient to support a Marketing Authorization Application without any Phase 1 or Phase 2 clinical trials; and (ii) in a manner 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. |
| (ppp) | “Regulatory Approval” means, with respect to a country or other jurisdiction, all registrations, authorization or approval by any Competent Authority, necessary for a Licensed Product to be sold in such country or jurisdiction. For clarity, Regulatory Approval may, in a particular country, include pricing approval. |
| (qqq) | “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights conferred by any Competent Authority with respect to a Licensed Product in a country, other than a Patent Right but including patent term extension based on FDA or other Competent Authority review times and |
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| research times, in each case, that confers exclusive rights to NextCure, its Affiliates or Sublicensees, as applicable to market such Licensed Product in such country. As an example, and not a limitation of the foregoing definition, as of the Effective Date, Regulatory Exclusivity includes in the U.S., the applicable period of exclusivity for an initial reference product granted under the U.S. Biologics Price Competition and Innovation Act of 2009. |
| (rrr) | “Representatives” means, with respect to a Party, the directors, officers, employees, consultants, advisors and permitted contractors of such Party. |
| (ttt) | “Respective Territory” means with respect to Zaiming, the Zaiming Territory, and with respect to NextCure, the NextCure Territory. |
| (uuu) | “Results” means all data, information, or materials identified, developed, generated, created, or conceived in the exercise of this Agreement, including all tangible records of such data and information. |
| (vvv) | “Royalty Term” means, on a country-by-country basis and Licensed Product-by-Licensed Product basis, the period commencing on the date of the First Commercial Sale of such Licensed Product in such country and ending on the latest of: |
| (i) | the date of expiry of the last Valid Claim of a Patent Right included in the Zaiming Patent Rights Covering such Licensed Product in such country; |
| (ii) | ten (10) years from the First Commercial Sale of such Licensed Product in such country; or |
| (iii) | the expiration of all Regulatory Exclusivity for such Licensed Product in such country. |
| (www) | “Selling Entity” means NextCure, or its Affiliates, or Sublicensees. |
| (xxx) | “Senior Officers” means for ▇▇▇▇▇▇▇, the Chief Executive Officer of Zaiming or his/her designee, and for NextCure, the Chief Executive Officer of NextCure or his/her designee. |
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| (zzz) | “Sublicensee” means (i) a Third Party to which a Party or its Affiliate grants a Sublicense, and (ii) a Third Party to whom such Third Party defined in the foregoing clause (i) grants a license or sublicense (through multiple tiers) in the Field under any of the Zaiming IP or NextCure IP, as applicable. |
| (aaaa) | “Third Party” means a person other than ▇▇▇▇▇▇▇, NextCure or each of their Affiliates. |
| (bbbb) | “United States” or “US” means the United State of America and its territories and possessions. |
| (eeee) | “Valid Claim” means a claim of: |
| (ii) | a pending patent application that has not been pending for more than seven (7) years from its initial filing date and has not been finally rejected by a patent office or other governmental agency of competent jurisdiction in an unappealable decision or a decision that is un-appealed within the time allowed for appeal. Notwithstanding the foregoing, if a claim of a patent application that ceased to be a Valid |
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| Claim under the foregoing later issues or is granted as a patent within the scope of the above subclause (i), then such claim will be considered a Valid Claim from the date of such issuance or grant. |
| (hhhh) | “Zaiming IP” means Zaiming Know-How, Zaiming Patent Rights. |
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| shall be included as Zaiming Patent Rights. All Zaiming Patent Rights as of the Effective Date are set forth on Schedule 1.1(jjjj). |
(mmmm)“Zaiming Territory” means the mainland China, Hong Kong, Macau and Taiwan.
| 1.2 | Other Defined Terms. The following terms shall have the meanings defined for such terms in the Sections set forth below: |
Term | Section |
“Acquirer” | 4.6(b) |
4.2 | |
“Anti-Corruption Laws” | 9.7(a) |
“Arbitration Rules” | 12.3(b) |
“Claims” | 10.3(a) |
“Competing Activities” | 4.6(b) |
“Code” | 11.3(a) |
“Cure Period” | 11.2(a) |
“Cessation Period” | 11.2(d)(iii) |
“Development Milestone Event” | 6.2 |
“Development Milestone Payment” | 6.2 |
“Disclosing Party” | 1.1(x) |
“Dispute” | 12.1 |
“EMA” | 1.1(u) |
“Enforcing Party” | 7.4(d) |
“Expediated Arbitration” | 12.4 |
“First Payment” | 6.1(a) |
“Force Majeure” | 13.8 |
“Indemnifying Party” | 10.3(c) |
“Indemnitee” | 10.3(c) |
“Infringement Claim” | 7.5(a) |
“Initial Supply” | 4.8(a) |
“Joint Arising IP” | 7.1(a) |
“Joint Steering Committee” or “JSC” | 5.1 |
“Losses” | 10.3(a) |
“Manufacturing Technology Transfer by NextCure” | 4.8(c) |
“Manufacturing Technology Transfer by Zaiming” | 4.8(b) |
“Material Matters” | 5.7(b) |
“NextCure Arising IP” | 7.1(a) |
“NextCure CMO” | 4.8(b) |
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“NextCure-Developed Materials” | 11.5(c)(i) |
“NextCure Exclusive License Grant” | 11.5(c)(ii) |
“NextCure Indemnitees” | 10.3(b) |
“NextCure Program” | 4.1(c) |
“NextCure Prosecuted Patents” | 7.3(a) |
“Opening Brief” | 12.4(b) |
“Patent Challenge” | 11.2(d)(ii) |
“Pharmacovigilance Agreement” | 4.3(d) |
“PMDA” | 1.1(u) |
“Product Marks” | 7.7 |
“Receiving Party” | 1.1(x) |
“Response Brief” | 12.4(b) |
“Royalty Report” | 6.5 |
“Sales Milestone Event” | 6.3 |
“Sales Milestone Payment” | 6.3 |
“SIM0505” | 1.1(gggg) |
“Supply Agreement” | 4.8(a) |
“Term” | 11.1 |
“Terminated Compound” | 11.5(a) |
“Terminated Product” | 11.5(a) |
“Third Party Infringement” | 7.4(a) |
“Upstream Licensor of NextCure” | 1.1(cccc) |
“Upstream Licensor of Zaiming” | 1.1(dddd) |
“Zaiming Arising IP” | 7.1(a) |
“Zaiming CMO” | 4.8(c) |
“Zaiming Indemnitees” | 10.3(a) |
“Zaiming Platform Improvement” | 7.1(a) |
“Zaiming Platform Patents” | 7.3(c) |
“Zaiming Prosecuted Patents” | 7.3(b) |
| 1.3 | In this Agreement: |
| (a) | references to Parties, Sections and Schedules are to the Parties, Sections and Schedules of this Agreement; |
| (b) | references to persons include all forms of legal entity including an individual, company, body corporate, unincorporated association and partnership, and such persons’ successors and assigns; |
| (c) | the words “include,” “including,” and “in particular” are to be construed as being by way of illustration or emphasis only and are not to be construed so as to limit the generality of any words preceding them; |
| (d) | the words “other” and “otherwise” are not to be construed as being limited by any words preceding them; |
| (e) | the headings are used for convenience only and do not affect its interpretation; |
| (f) | any financial sums are expressed in US Dollars unless otherwise specified; |
| (g) | the term “or” means “and/or” hereunder; |
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| (h) | the word “will” shall be construed to have the same meaning and effect as the word “shall”; |
| (i) | “herein,” “hereby,” “hereunder,” “hereof” and other equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used; |
| (j) | 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); |
| (k) | 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; |
| (l) | 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 |
| (m) | a reference to the singular includes a reference to the plural and vice versa and a reference to any gender includes a reference to all other genders. |
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.
| 2.1 | License Grants to NextCure. Subject to the terms of this Agreement, Zaiming hereby grants to NextCure, on behalf of itself and its Affiliates: |
| (b) | a non-exclusive, transferable (solely as permitted in accordance with Section 13.3 (Assignment)) license under the Zaiming IP for the NextCure Compounds and NextCure Products with the right to sublicense through multiple tiers, to Develop NextCure Compounds, including as NextCure Products, using the Zaiming ADC Platform Technology, and to Exploit the NextCure Compounds and NextCure Products, in the Field in the NextCure Territory; and |
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| NextCure any right or license to Commercialize any Licensed Compounds or Licensed Products in the Zaiming Territory); provided that prior to each instance of exercising the foregoing non-exclusive license with respect to a particular Third Party service provider and a particular set of (sub)contracted activities, NextCure shall provide Zaiming with written notice setting forth the name of such Third Party service provider, the activities to be performed by such Third Party service provider and the geographical location where such activities will be performed (it being understood and agreed that the requirement to provide the foregoing notice does not limit or negate the requirements of Section 3.3 (Subcontracting), which are independent requirements). |
| 2.2 | License Grants to Zaiming. Subject to the terms of this Agreement, NextCure hereby grants to Zaiming and its Affiliates: |
| (a) | an exclusive (even as to NextCure and its Affiliates), fully-paid up, royalty-free, transferable (solely as permitted in accordance with Section 13.3 (Assignment)) license under the NextCure IP for the NextCure Compounds and NextCure Products, with the right to sublicense through multiple tiers, to Exploit the NextCure Compounds and NextCure Products in the Field in the Zaiming Territory; |
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| 2.3 | No Other License and Retained Rights. No rights, other than those expressly set forth in this Agreement, are granted to either Party hereunder, and no additional rights shall be deemed granted to either Party by implication, estoppel or otherwise. All rights not expressly granted by either Party to the other hereunder are reserved. Notwithstanding the exclusive licenses granted under Section 2.1 (License Grants to NextCure) or Section 2.2 (License Grants to Zaiming), (a) each Party retains the right to practice the Zaiming IP (in case of Zaiming) or NextCure IP (in case of NextCure) to fulfil its obligations under this Agreement, (b) NextCure retains the right to conduct non-clinical Development activities or, solely to the extent permitted under Section 4.1(d) (NextCure Proposed MRCT), conduct clinical Development activities, Manufacture or have Manufactured Licensed Compounds and Licensed Products outside the NextCure Territory, solely for the Exploitation of Licensed Compounds and Licensed Products in the NextCure Territory, and (c) Zaiming retains the right to conduct non-clinical Development activities, Manufacture or have Manufactured Licensed Compounds and Licensed Products outside the Zaiming Territory, solely for the Exploitation of Licensed Compounds and Licensed Products in the Zaiming Territory. |
| 2.4 | Technology Transfer. |
| (c) | Costs of Technology Transfer. Each Party will be responsible for its costs incurred in connection with the technology transfer set forth under this Section 2.4 (Technology Transfer). |
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| (d) | For clarity, the technology transfer conducted under this Section 2.4 (Technology Transfer) shall not include the transfer of manufacturing technology, which shall be conducted pursuant to Section 4.8(b) (Manufacturing Technology Transfer by Zaiming) or Section 4.8(c) (Manufacturing Technology Transfer by NextCure), as applicable. |
| (b) | NextCure shall within fifteen (15) Business Days after the effective date of each Sublicense, provide a complete copy of each executed sublicense agreement to Zaiming (provided that in the case of amendments to such sublicense agreement, a copy of such amendment shall be provided to Zaiming after the execution of such amendment). NextCure may make reasonable redactions where the redactions do not adversely impact the rights of ▇▇▇▇▇▇▇ hereunder, provided the redacted copy enables ▇▇▇▇▇▇▇ to determine the scope of the rights granted, the financial terms thereunder to the extent applicable to Zaiming and confirm compliance with obligations under this Agreement; |
| (c) | Such Sublicense shall not be solely under the Zaiming ADC Platform Technology as standalone components independent of the Licensed Product; and |
| (d) | NextCure shall remain directly responsible for all of its obligations under this Agreement. |
| (a) | Such Sublicense shall be subject to and consistent with the terms of this Agreement, and shall be granted pursuant to a written agreement, where the applicable Sublicensee agrees to be bound by the obligations of the following provisions of this Agreement to the extent applicable to Sublicensee’s activities in the same manner in which Zaiming is obligated, including but not limited to: this Section 3.2 (Sublicenses by ▇▇▇▇▇▇▇), Section 4.6 (Non-Competition), Article 7 (Intellectual Property) and Article 8 (Confidential Information) with respect to NextCure’s Confidential Information; |
| (b) | Zaiming shall within fifteen (15) Business Days after the effective date of each Sublicense, provide a complete copy of each executed sublicense agreement to NextCure (provided that in the case of amendments to such sublicense |
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| agreement, a copy of such amendment shall be provided to NextCure after the execution of such amendment), including a translation into English (if applicable). Zaiming may make reasonable redactions where the redactions do not adversely impact the rights of NextCure hereunder, provided the redacted copy enables NextCure to determine the scope of the rights granted and confirm compliance with obligations under this Agreement; and |
| (c) | Zaiming shall remain directly responsible for all of its obligations under this Agreement. |
| 4.1 | Development Responsibilities. |
| (b) | Of Zaiming Products by Zaiming. Subject to Article 5 (Governance) below regarding the oversight by the JSC, ▇▇▇▇▇▇▇ will lead and have sole control and decision-making authority with respect to the Development of Zaiming Products in the Zaiming Territory at its own cost and expense. Notwithstanding the foregoing, following the Effective Date Zaiming shall use Commercially Reasonable Efforts to continue to advance the current Phase 1 Clinical Trial of SIM0505 (registration no. NCT06792552) in the Zaiming Territory in accordance with the current protocol. |
| (c) | NextCure Program. NextCure will after the Effective Date, directly or through its Affiliates or one or more Sublicensees or subcontractors as |
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| permitted under this Agreement, commence a research program for the pre-clinical Development (including conducting research and pre-clinical design work with the assistance of ▇▇▇▇▇▇▇ as set forth in the Research Plan) of the NextCure Compounds, including NextCure Products containing such compounds (the “NextCure Program”). NextCure shall not modify or improve the structure of the payload or linker portion of the Zaiming ADC Platform Technology for the Development of NextCure Compounds. Zaiming will provide technology transfer and materials as set forth in the Research Plan to enable manufacturing of non-GMP research grade batches of the NextCure Compounds. Except as set forth in the Research Plan, each Party shall be responsible for its own costs and expenses in conducting the Research Plan with the proviso that following the conjugation of NextCure Compounds, NextCure thereafter will carry out at NextCure’s cost and expenses any reasonably necessary preclinical research to generate NextCure Compounds activity and safety data with the goal of supporting potential regulatory filings (including an IND Application) in accordance with the Research Plan. If and when NextCure has selected in its discretion a NextCure Compound as a clinical candidate that NextCure wishes to advance as a NextCure Product to clinical trials, it will prepare and submit to the JSC an amendment to the Development Plan to include Development activities relating to such NextCure Compound, thereby expanding the NextCure Program into clinical stage activities, and NextCure shall use Commercially Reasonable Efforts to Develop and obtain the Regulatory Approval for at least one NextCure Product for at least one Indication in the U.S. and at least one other Major Market Country, with the proviso that NextCure may in its discretion elect to pursue Regulatory Approvals, and conduct Development in support of such Regulatory Approvals, serially instead of for multiple countries in parallel. |
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| (f) | MRCT Conduct. In the event that the Parties agree to participate jointly in a multi-center clinical trial for any Licensed Product that includes clinical sites in both the Zaiming Territory and the NextCure Territory, the Parties will modify the Development Plan to include activities and deliverables agreed to be performed by each respective Party. Each Party will diligently perform its respective responsibilities set forth in the Development Plan for any such multi-center clinical trial. |
| (a) | the progress of Development for the Licensed Compounds and Licensed Products in such each Party’s Respective Territory, and with respect to NextCure, measured against the Development Plan; |
| (b) | solely in the case of NextCure, for each Major Market Country where all required Regulatory Approvals have been obtained for the Licensed Products, at least ninety (90) Days prior to launch of a Licensed Product in such country or region, a summary of the Commercialization strategy and plan of NextCure in respect of the Licensed Product in such Major Market Country; |
| (c) | the Parties shall discuss the Annual Report and the progress of Commercialization activities in the NextCure Territory as measured against the Commercialization strategy and plan; and |
| (d) | each Party shall have the opportunity to ask questions about the other Party’s Annual Report and the other Party shall be reasonably available and, in any event, respond to such first Party’s questions within thirty (30) Days. |
| 4.3 | Regulatory Matters. |
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| regard to Licensed Products in its Respective Territory. Each Party shall have the right to review and provide comments on material regulatory materials related to the Licensed Products in the other Party’s Respective Territory unless prohibited by applicable law. Each Party will own any and all Regulatory Approvals and regulatory submissions for each Licensed Product in its Respective Territory, which will be held in the name of such Party or its designees. To the extent there are any Regulatory Approvals, regulatory submissions or the like for any Licensed Product in the NextCure Territory Controlled by Zaiming, Zaiming shall promptly and diligently convey or assign them to NextCure or its designees after NextCure initiates preparation for clinical activities for the respective Licensed Product in the NextCure Territory and after Zaiming’s receipt of the First Payment. |
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| Regulatory Approvals and related regulatory materials in the other Party’s Respective Territory as provided herein. |
| 4.5 | Medical Affairs. Each Party shall lead and have sole control over and decision-making authority with respect to all aspects of Medical Affairs of the Licensed Products in its Respective Territory, subject to the terms and conditions of this Agreement. |
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| 4.6 | Non-Competition. |
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| 4.8 | Manufacturing and Supply. |
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| Party CMOs, to the extent NextCure has the right to assign, transfer or sublicense such materials under its agreements with such Third Party CMOs; provided that NextCure shall use good faith efforts to obtain such right), necessary or reasonably useful for Zaiming or the Zaiming CMO to Manufacture the NextCure Compounds and NextCure Products (the “Manufacturing Technology Transfer by NextCure”) in accordance with a Manufacturing technology transfer plan to be agreed by the Parties. At the reasonable request of ▇▇▇▇▇▇▇ from time to time, NextCure shall make its employees and consultants (including personnel of its Affiliates and Third Party CMOs) available to Zaiming and the Zaiming CMO to provide reasonable consultation and technical assistance in order to ensure an orderly transfer of such materials and technology to Zaiming and the Zaiming CMO and to assist Zaiming and the Zaiming CMO in the Manufacture of the NextCure Compounds or NextCure Products. Zaiming shall reimburse any reasonable, documented NextCure’s Third Party expenses and FTE costs exceeding one hundred (100) hours at NextCure’s FTE rate pre-approved by Zaiming for conducting activities under this Section 4.8(c) (Manufacturing Technology Transfer by NextCure), within thirty (30) Days after receipt of each invoice therefor from NextCure. The Parties shall start the Manufacturing Technology Transfer by NextCure in accordance with the timelines set forth in the Manufacturing technology transfer plan, and each Party shall use Commercially Reasonable Efforts to achieve complete the Manufacturing Technology Transfer by NextCure within the timelines set forth in the manufacturing technology transfer plan. For clarity, the Manufacturing Technology Transfer by NextCure will be conducted once only with respect to a NextCure Compound and NextCure Product, regardless of whether to Zaiming or the Zaiming CMO, except in the case of material revisions to the NextCure Product and/or process by NextCure after the completion of the Manufacturing Technology Transfer by NextCure in which case NextCure shall provide Zaiming with reasonable assistance as requested by Zaiming at Zaiming’s cost. Following the completion of the Manufacturing Technology Transfer by NextCure, Zaiming shall be solely responsible to Manufacture or have Manufactured such NextCure Compound and NextCure Product for Development and Commercialization use by Zaiming in the Field in the Zaiming Territory. Zaiming may Manufacture the Licensed Compounds and Licensed Products on its own or have one or more Third Parties designated by Zaiming and reasonably acceptable to NextCure, or with respect to a Third Party located in the NextCure Territory, reasonably approved by NextCure (each a “Zaiming CMO”) to Manufacture the Licensed Compounds and Licensed Products solely to Exploit the Licensed Compounds and Licensed Products in the Field in the Zaiming Territory (for clarity, including to conduct non-clinical Development activities in the NextCure Territory). |
| (d) | Without limiting Section 4.8(b) (Manufacturing Technology Transfer by Zaiming) or Section 4.8(c) (Manufacturing Technology Transfer by NextCure), at the request of a Party, the other Party shall, and shall cause its Affiliates or CMOs to transfer stable cell lines it uses to the requesting Party or its CMO, and supply culture medium and other raw materials to the requesting Party or its CMO on terms and conditions agreed upon by the Parties. Notwithstanding the foregoing, each Party shall be responsible for obtaining the licenses of all cell lines or other biological materials in connection with its and its Affiliates’ and Sublicensees’ Exploitation of the Licensed Product, and shall be solely responsible for all such fees and costs arising from such use of the cell line after the Effective Date; provided that NextCure shall be entitled to deduct the payments with respect to the licenses |
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| of all cell lines (including the proprietary materials for gene editing for cell lines) for the Licensed Products pursuant to Section 6.4(b) and Section 6.4(e). |
| (e) | Prior to the completion of Manufacturing Technology Transfer by NextCure pursuant to Section 4.8(c) (Manufacturing Technology Transfer by NextCure), with regard to the supply of any NextCure Products for Zaiming’s and its Affiliates’ and Sublicensees’ Development activities in the Zaiming Territory, within ninety (90) Days following Zaiming’s request, the Parties shall negotiate in good faith and enter into a clinical supply agreement and related quality agreement on commercially reasonable terms pursuant to which Zaiming may obtain clinical supply of the respective NextCure Product from NextCure or a NextCure CMO under FOB terms (Incoterms 2020) with the supply prices being NextCure’s cost of goods plus a ten percent (10%) mark-up, subject to annual adjustment at a rate no less than the inflation rate in the twelve (12) months immediately preceding the adjustment, for which Zaiming shall be responsible for arranging shipping and insurance thereof, all at Zaiming’s own cost and expense. |
| 5.2 | JSC Membership. Within forty-five (45) Days after the Effective Date, each Party shall designate two (2) representatives for the JSC and be responsible for its representatives’ compliance with the terms of this Agreement and that each representative has agreed in advance to confidentiality, intellectual property ownership and assignment and non-use obligations at least as restrictive as those set forth herein. Each representative shall have the appropriate level of experience in the subject area of the JSC, and at least one representative shall have sufficient seniority within the applicable Party’s organization to have the necessary decision-making authority in order for the JSC to fulfil its responsibilities. Either Party may designate a substitute for its JSC representatives if one of such Party’s designated representatives is unable to be present at a meeting so long as such substitutes are subject to the same obligations of confidentiality, intellectual property ownership and assignment and non-use as the formal representative. From time to time, each Party may replace its JSC representatives by written notice to the other Party specifying the prior representative(s) and their replacement(s). |
| 5.3 | JSC Chairperson. Each Party shall designate one (1) of its representatives on the JSC to act as the co-chairperson. The co-chairperson shall be responsible for calling and convening meetings. The co-chairperson (or its designate) shall: (i) prepare and circulate an agenda reasonably in advance of each upcoming meeting; and (ii) prepare and issue minutes of the JSC meeting within thirty (30) Days thereafter. Such minutes shall not be finalized until each JSC representative reviews and approves such minutes in writing; provided that any minutes shall be deemed approved unless a JSC representative objects to the accuracy of such minutes within fifteen (15) Days after the circulation of the minutes. |
| 5.4 | Meetings. |
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| (a) | Timing and Frequency. Unless otherwise agreed by the Parties, the JSC shall meet at least once each Calendar Quarter until such time as each Licensed Product currently being advanced by either Party has reached First Commercial Sale in one country in each of the NextCure Territory and the Zaiming Territory (applied mutandis mutatis). Additional meetings of the JSC may be held with the consent of each Party (such consent not to be unreasonably withheld, delayed or conditioned), and as required under this Agreement. The JSC shall disband when both Parties (and their Affiliates and Sublicensees) cease all Development activities of the Licensed Compounds and Licensed Products under this Agreement. |
| (b) | Meeting Procedures. The JSC may meet either (i) in person at either Party’s facilities or at such locations as the Parties may otherwise agree; or (ii) by audio or video teleconference. Each Party shall be responsible for all of its own expenses incurred in connection with participating in the JSC, including all travel and lodging. |
| 5.5 | Non-Member Participation. Additional non-members of the JSC having relevant experience may from time to time be invited to participate in a JSC meeting, provided that such participants shall have no voting rights or powers. Non-member participants who are not employees of a Party or its Affiliates shall only be allowed to attend if (a) such Party gives the other Party at least five (5) Days’ advance written notice of the identity of such non-member participant, and (b) such non-member participant is subject to and has agreed in advance to confidentiality, intellectual property ownership and assignment and non-use obligations at least as restrictive as those set forth in this Agreement. |
| 5.6 | JSC Responsibilities. The JSC’s responsibilities shall be to: |
| (a) | Discuss the Development Plan, Research Plan and discuss and approve all proposed material amendments and updates thereto; |
| (b) | Coordinate the technology transfer activities pursuant to Section 2.4 (Technology Transfer) or as otherwise set forth in the Research Plan or the Development Plan; |
| (c) | Discuss each proposed NextCure Program and any multi-center clinical trials for any Licensed Product and the other Party’s participation pursuant to Section 4.1(d) (NextCure Proposed MRCT) or Section 4.1(e) (Zaiming Proposed MRCT), as applicable; |
| (d) | Facilitate the exchange of Data and other information between the Parties related to the Development of the Licensed Products in their Respective Territory, including under the Development Plan or described in their Annual Reports; |
| (e) | Review, discuss, and coordinate the overall progress and timelines of the Development activities and regulatory activities for the Licensed Compounds and Licensed Products conducted by or on behalf of each Party, their Affiliates and their Sublicensees; |
| (f) | Review and discuss each Party’s clinical strategies and clinical plans of the Licensed Product; |
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| (g) | Serve as the first forum to hear and resolve disputes in respect of Development matters; |
| (h) | Perform such other functions as appropriate to further the Development of the Licensed Compounds or Licensed Products, as determined by the Parties in writing; and |
| (i) | Convene and empower, and appoint representatives to, any subcommittee or working group of the JSC to address specific items of interest (e.g., clinical trial design, technology transfer and CMC activities, etc.). |
| 5.7 | JSC Decisions and Actions. |
| (a) | The Parties shall use good faith efforts to achieve consensus regarding any actions. If the JSC fails to reach agreement on a matter for which it has the authority to determine under Section 5.6 (JSC Responsibilities) within fifteen (15) Days after such matter was brought to the JSC for resolution, such disagreement shall be referred to the Senior Officers of the Parties for resolution, who shall use good faith efforts to meet and resolve such matter within thirty (30) Days after it is referred to them. |
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| products (or such other similar credentials as mutually agreed by the Parties). Within ten (10) Days after the expert panel has been selected, each Party will provide to the expert panel and the other Party a written report setting forth its position on the dispute. Each Party may update its own report within ten (10) Days after receiving the other Party’s report. If requested by the expert panel, each Party will make oral submissions based on its written report and each Party will have the right to be present during any such oral submissions. Within thirty (30) Days after receiving the last report or, if requested by the expert panel, the oral submissions, the expert panel will select one Party’s position on the referred dispute as its final decision. The expert panel will not have the authority to modify either Party’s position or to render any substantive decision other than to select one Party’s position on the dispute as set forth in such Party’s written report most recently submitted to the expert panel. The decision of the expert panel will be the Parties’ sole, exclusive and binding resolution of the referred dispute, and the expert panel’s decision will be deemed to be the mutual agreement by the Parties on the matter. The costs and fees of the expert panel will be shared equally by the Parties. Each Party will bear its own costs of participating in the proceeding. The Parties will use, and will direct the expert panel to use, Commercially Reasonable Efforts to resolve the referred dispute within sixty (60) Days after either Party requests such resolution. The status quo of such matter shall persist until the matter is resolved by such Third Party expert panel. For clarity, any dispute subject to this Section 5.7(c) (Expert Panel) shall not be eligible for resolution pursuant to Article 12 (Dispute Resolution). |
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| average price per share of Common Stock for each of the thirty (30) trading days prior to and ending on the date of Initiation of the first Phase 2 Clinical Trial, as reported by the Nasdaq Stock Market, which shall be issued pursuant to the terms and conditions of the Equity Agreement. If in both Parties’ reasonable determination either (i) Zaiming is unable to lawfully receive such Common Stock, or (ii) NextCure cannot lawfully issue such Common Stock (including without first obtaining any required shareholder or regulator approvals), then in lieu of issuing such Common Stock, NextCure shall pay to Zaiming a one-time, non-refundable, non-creditable and non-cancellable cash payment of one million US Dollars ($1,000,000) within thirty (30) Days after such determination or, alternatively, shall issue such shares of Common Stock up to amount mutually agreed by the Parties as being a lawful amount for both Zaiming to receive and NextCure to issue and pay the balance as a one-time, non-refundable, non-creditable, and non-cancellable cash payment in US Dollars. Further, if NextCure assigns this Agreement in its entirety to a Third Party pursuant to Section 13.3(b) or partially to a Third Party acquirer with respect to the Zaiming Product pursuant to Section 13.3(c) before NextCure’s obligation under this Section 6.1(c) becomes due, then in lieu of NextCure issuing such Common Stock under this Section 6.1(c), the assignee of NextCure shall pay to Zaiming a one-time, non-refundable, non-creditable and non-cancellable cash payment of one million US Dollars ($1,000,000) no later than thirty (30) Days after Initiation of such first Phase 2 Clinical Trial for any Zaiming Product. |
Development Milestone Event | Payment (US Dollars, “M” = millions) | |
|---|---|---|
Zaiming Product | NextCure Product | |
Initiation of the first Phase 1 Clinical Trial for any Indication | [***] | [***] |
Initiation of the first Phase 2 Clinical Trial for any Indication | [***] | [***] |
Initiation of the first Registrational Trial for the Indication of [***] * | [***] | [***] |
Initiation of the first Phase 3 Clinical Trial for any Indication | [***] | [***] |
Submission of the first BLA to any Competent Authority for the Indication of [***] | [***] | [***] |
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Development Milestone Event | Payment (US Dollars, “M” = millions) | |
|---|---|---|
Zaiming Product | NextCure Product | |
BLA approval by the FDA | [***] | [***] |
MAA approval by the EMA or a Competent Authority in any Major Market Country in Europe | [***] | [***] |
Regulatory Approval in Japan by the PMDA | [***] | [***] |
* For clarity, when the Development Milestone Event “Initiation of the first Registrational Trial for the Indication of [***]” is first achieved for a Zaiming Product, if any of the Development Milestone Events “Initiation of the first Phase 1 Clinical Trial for any Indication”, “Initiation of the first Phase 2 Clinical Trial for any Indication” or “Initiation of the first Phase 3 Clinical Trial for any Indication” has not previously been achieved for the same Zaiming Product, such Development Milestone Event shall be deemed to have been achieved for such Zaiming Product, and the corresponding Development Milestone Payments shall become payable.
| (a) | A re-labelling or reformulation (including co-formulation with Other Components) of the same Licensed Compound present in a first Licensed Product into a second Licensed Product, where NextCure has already paid the respective Development Milestone Payment for such first Licensed Product, is not achievement of that respective milestone by a “different” Licensed Product for purposes of this Section 6.2 (Development Milestones), and therefore shall not trigger a second Development Milestone Payment due to the second Licensed Product. Further, for clarity no payment set forth in this Section 6.2 (Development Milestones) shall be payable more than once no matter how many times an applicable Licensed Product achieves the same Development Milestone Event. |
| (b) | NextCure shall notify ▇▇▇▇▇▇▇ in writing upon the first achievement, in respect of a Licensed Product, by or on behalf of NextCure or its Affiliate or Sublicensee, of each of the Development Milestone Events no later than thirty (30) Days of NextCure’s knowledge of achievement thereof; provided that in any event, such notice must be provided with forty-five (45) Days following achievement of each Development Milestone Event. Within thirty (30) Days of receipt of an appropriate invoice from Zaiming, NextCure shall pay the applicable Development Milestone Payment due because of such achievement of the corresponding Development Milestone Event. |
| (c) | In the event that the Development Milestone Event regarding a Phase 1 Clinical Trial, Phase 2 Clinical Trial or Phase 3 Clinical Trial is skipped but the subsequent Development Milestone Event is achieved, the Development Milestone Payment for the Development Milestone Event that was skipped shall be paid concurrently with and in addition to the Development Milestone Payment for the subsequent Development Milestone Event. |
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| Compound and NextCure Product, as applicable, in the event that the Annual Net Sales made by or on behalf of a Selling Entity for a respective Licensed Product in the NextCure Territory in a given Calendar Year first exceeds a threshold as set forth in the table immediately below (each a “Sales Milestone Event”), NextCure shall pay to Zaiming the following one-time, non-refundable, non-creditable and non-cancellable milestone payments (each a “Sales Milestone Payment”). |
Sales Milestone Event | Payment (US Dollars, M = millions) | |
Zaiming Product | NextCure Product | |
Annual Net Sales of Licensed Product exceeds [***] | [***] | [***] |
Annual Net Sales of Licensed Product exceeds [***] | [***] | [***] |
Annual Net Sales of all Licensed Product exceeds [***] | [***] | [***] |
Annual Net Sales of all Licensed Product exceeds [***] | [***] | [***] |
| (a) | No payment set forth in this Section 6.3 (Sales Milestones) shall be payable more than once no matter how many times an applicable Licensed Product achieves the same Sales Milestone Event. Sales of all Licensed Products containing the same Licensed Compound (including re-labelling or reformulations thereof, including co-formulations with Other Components) shall be counted together for purposes of determining the applicable Annual Net Sales for any Sales Milestone Event thresholds in this Section 6.3 (Sales Milestones). For clarity, the total maximum potential amount payable to Zaiming under this Section 6.3 (Sales Milestones) is five hundred thirty-five million US Dollars ($535,000,000). |
| (b) | In the event that in a given Calendar Year more than one Sales Milestone Event is achieved, NextCure shall pay to Zaiming each separate Sales Milestone Payment with respect to each Sales Milestone Event that is achieved in such Calendar Year. |
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| of such Licensed Product that occur during the Royalty Term for such Licensed Product at the royalty rate set forth in the chart below. |
Annual Net Sales Threshold | Royalty Rate | |
Zaiming Product | NextCure Product | |
Portion of Annual Net Sales that is less than or equal to [***] | [***] | [***] |
Portion of Annual Net Sales that is greater than [***] but less than or equal to [***] | [***] | [***] |
Portion of Annual Net Sales that is greater than [***] but less than or equal to [***] | [***] | [***] |
Portion of Annual Net Sales that is greater than [***] | [***] | [***] |
| (a) | Concurrent with the Royalty Report pursuant to Section 6.5 (Royalty Reports), NextCure shall pay to Zaiming royalties calculated pursuant to this Section 6.4 (Royalty Payments). Sales of all Licensed Products containing the same Licensed Compound (including re-labelling or reformulations thereof, including co-formulations with Other Components) shall be counted together for purposes of determining the applicable Annual Net Sales for any royalty rate thresholds in this Section 6.4 (Royalty Payments). |
| (c) | Subject to Section 6.4(e), on a Licensed Product-by-Licensed Product and country-by-country basis in the NextCure Territory, if during any Calendar Quarter in the applicable Royalty Term for a Licensed Product, such Licensed Product is not Covered by any Valid Claim of any Patent Rights in the Zaiming Patent Rights in such country in the NextCure Territory at the time of such sale, then the royalties due for the Net Sales of such Licensed Product in such country for such Calendar Quarter hereunder shall be reduced by [***] percent [***]. |
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| respect to a Licensed Product, and (y) the unit volume of all Biosimilars to such Licensed Product that are sold by Third Parties in such country is equal to or exceeds [***] percent [***] of the combined unit volume of such Licensed Product and such Biosimilar sold in such country during such Calendar Quarter, then, the royalties due for the Net Sales of such Licensed Product in such country for such Calendar Quarter hereunder shall be reduced by [***] percent [***] for such Calendar Quarter. |
| 6.6 | Payments and Taxes. All sums due under this Agreement: |
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| to obtain a refund of such withheld taxes and any appropriate relief from double taxation of the payment in question. The Parties agree to cooperate in good faith with one another and use reasonable efforts to eliminate or reduce any VAT in respect of any payments made by a Party to the other Party under this Agreement, to the extent permitted by applicable law. All payments under this Agreement are exclusive of VAT other than any VAT imposed by the tax authority in the country where the payee locates, if any, which shall be borne by the payee. If any VAT is required in respect of any payments under applicable law (other than as imposed by the tax authority in the country where the payee locates), the payor will pay VAT at the applicable rate in respect of any such payments following the receipt of a valid VAT invoice in the appropriate form issued by the payee in respect of those payments, such VAT to be payable on the later of the due date of the payments to which such VAT relates and thirty (30) Days after the receipt by the payor of the applicable valid invoice relating to that VAT payment. The payor will not be responsible for any penalties and interest resulting from the failure by the payee to collect (if not included on a valid VAT invoice) or remit any such VAT. Notwithstanding anything to the contrary, if as a result of any action by a Party, including assignment, any change in such Party’s tax residency, or any failure on the part of such Party to comply with applicable laws (including filing or record retention requirements), incremental taxes are imposed that were not otherwise applicable, then such Party shall be solely responsible for the amount of such incremental taxes. |
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| 6.7 | No Third Party Payments. As between the Parties, Zaiming shall be fully and solely responsible for any and all payments to any Upstream Licensors of Zaiming under the Upstream Licenses of Zaiming applicable to the Zaiming Compound or the Zaiming ADC Platform Technology incorporated into any NextCure Compounds to the extent such Upstream Licenses of Zaiming exist as of the Effective Date, including Manufacturing costs, milestone payments and royalty payments payable thereof. |
| 6.8 | Blocked Payments. If, by reason of applicable law or other Force Majeure in any country or region, it becomes impossible or illegal for NextCure to transfer, or have transferred on its behalf, any payments to Zaiming, then NextCure will promptly notify Zaiming of the conditions preventing such transfer and, per the request of Zaiming, such payments shall be deposited (in the relevant local currency) to the credit of Zaiming in a recognized banking institution that is designated by Zaiming; provided that such arrangements do not violate applicable law. |
| 7.1 | Ownership of Arising IP. |
| (b) | Each Party will promptly disclose to the other Party any Arising IP solely or jointly owned by the other Party that is developed, created, conceived, or reduced to practice by or on behalf of such Party or any of its Affiliates or Sublicensees during the Term, in any event within thirty (30) Days, after becoming aware of such Arising IP. Each Party will obligate any employees, Sublicensees, and Third Party contractors to assign all Arising IP to such Party so that each Party can comply with its obligations under this Section 7.1 (Ownership of Arising IP), and each Party will promptly obtain such assignment. |
| (c) | Each Party will have an undivided one-half (1/2) interest in and to the Joint Arising IP. Each Party, for itself and on behalf of any of its Affiliates, licensees and Sublicensees, and employees, subcontractors, consultants and agents of any of the foregoing, hereby assigns (and to the extent such assignment can |
41
| only be made in the future hereby agrees to assign), to the other Party a joint and undivided interest in and to all Joint Arising IP. Subject to Section 2.1 (License Grants to NextCure) and Section 2.2 (License Grants to Zaiming), each Party is entitled to practice the Joint Arising IP for all purposes on a worldwide basis and to license such Joint Arising IP on a non-exclusive basis through multiple tiers without consent of the other Party (where consent is required by applicable law, such consent is deemed hereby granted) and without accounting to the other Party. |
| 7.3 | Prosecution and Maintenance. |
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| shall permit Zaiming, at its discretion and expense, to continue prosecution or maintenance of such NextCure Prosecuted Patent in such country. |
| (d) | Cooperation. Each Party will provide the other Party, at the other Party’s request and expense, all reasonable assistance and cooperation in the patent prosecution and maintenance efforts under this Section 7.3 (Prosecution and Maintenance), including providing any necessary powers of attorney and access to relevant persons and executing all required documentation for such prosecution. |
| 7.4 | Patent Enforcement. |
| (a) | Notification. Each Party will promptly notify the other Party of (i) any infringement, misappropriation, or other violation by a Third Party of any of |
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| the Zaiming IP or NextCure IP in the Field in the NextCure Territory or Zaiming Territory of which it becomes aware, including any “patent certification” filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions in other jurisdictions of any of the Zaiming Patent Rights or NextCure Patent Rights (collectively, “Third Party Infringement”); and (ii) any request for declaratory judgment, opposition, nullity action, interference, inter-partes reexamination, inter-partes review, post-grant review, derivation proceeding, or similar action alleging the invalidity, unenforceability or non-infringement or any request for declaratory judgment, or similar action alleging non-infringement of any of the Zaiming Patent Rights or NextCure Patent Rights. |
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| material papers to the competent court. The other Party shall be entitled to separate representation in such matter by counsel of its own choice and at its expense, but such Party shall at all times cooperate reasonably with the Enforcing Party. The Enforcing Party shall not enter into any settlement admitting the invalidity of the applicable Patent Rights that it brought under Section 7.4(b) (NextCure Prosecuted Patents) or Section 7.4(c) (Zaiming Prosecuted Patents), or otherwise altering, diminishing, or in derogation of the other Party’s rights under this Agreement, without the prior written consent of the other Party, not to be unreasonably withheld, conditioned or delayed. |
| (e) | Expenses and Recoveries. Any recoveries resulting from such an action relating to a claim of Third Party Infringement brought under Section 7.4(b) (NextCure Prosecuted Patents) or Section 7.4(c) (Zaiming Prosecuted Patents) shall be first applied proportionally against payment of each Party’s costs and expenses in connection therewith. If NextCure brought such action, any remainder will be retained by (or if received by ▇▇▇▇▇▇▇, paid to) NextCure; provided, however, that any portion of such remainder that is attributable to lost profits with respect to a Licensed Product shall be subject to a royalty payment to Zaiming as if such portion was Net Sales under this Agreement; and if Zaiming brought such action, any remainder shall be retained by (or if received by NextCure, paid to) Zaiming. |
| (f) | Enforcement of Zaiming Platform Patents. As between the Parties, ▇▇▇▇▇▇▇ will have the sole right, but not the obligation, to bring and control any legal action in connection with any infringement with respect to any Zaiming Platform Patents anywhere in the world at its expense as it reasonably determines appropriate (including deciding on any litigation strategy), and any recoveries or monetary awards resulting from such enforcement shall belong solely to Zaiming. For clarity, NextCure shall have no right to review, comment on, or otherwise influence the enforcement of any Zaiming Platform Patents, but Zaiming shall keep NextCure reasonably informed of Zaiming’s status in the enforcement of any Zaiming Platform Patents to the extent applicable to the Licensed Products. |
| 7.5 | Defense. |
| (b) | As between the Parties, each Party shall have the sole right, but not the obligation, to defend, settle, or otherwise take actions with respect to, any Infringement Claim arising from such Party’s, its Affiliates’ or Sublicensees’ activities; provided that, neither Party shall agree to any settlement, consent to judgment or other voluntary final disposition in connection with such defense action without the other Party’s consent (such consent not to be unreasonably withheld, conditioned or delayed) if such settlement, consent to judgment or other voluntary final disposition would diminish in any material respect the |
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| rights or interests of the other Party under this Agreement. The defending Party shall keep the other Party reasonably informed on the status of such defense action, and the other Party shall, at defending Party’s expense, (i) provide reasonable support to defending Party upon the defending Party’s reasonable request; and (ii) have the right, but not the obligation, to participate or be separately represented in such defense action at its sole option and expense. |
| 8.1 | Confidentiality Obligations. Except as provided in this Article 8 (Confidential Information), each Receiving Party shall: |
| (a) | keep the Confidential Information of the Disclosing Party secret and confidential at all times; |
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| (b) | not disclose or permit the disclosure of any Confidential Information of the Disclosing Party, in whole, in part, or in summary, to any person, except as expressly permitted by this Agreement; |
| (c) | take reasonable steps necessary to prevent the unauthorized disclosure or use of any of the Confidential Information of the Disclosing Party; |
| (d) | not use the Confidential Information of the Disclosing Party or permit it to be used, in whole or in part, for any purpose other than performance of the obligations and enjoyment of the rights granted under this Agreement; and |
| (e) | inform the Disclosing Party immediately if it becomes aware of the possession, use or knowledge of any of the Confidential Information of the Disclosing Party by a Third Party, and to provide any assistance in relation to such unauthorised possession, use or knowledge that the Disclosing Party may reasonably require. |
| 8.2 | Exceptions. Information of a Disclosing Party will not be considered Confidential Information to the extent that the Receiving Party can prove by means of reasonable written evidence: |
| (a) | was known to the Receiving Party prior to disclosure by the Disclosing Party and at its free disposal; |
| (b) | is or becomes publicly known other than as a result of breach of this Agreement by the Receiving Party or by anyone to whom the Receiving Party disclosed the Confidential Information of the Disclosing Party; |
| (c) | is received by the Receiving Party from a Third Party lawfully entitled to make the disclosure without restrictions on the Receiving Party’s rights to disclose or use; or |
| (d) | is developed by any of the Receiving Party’s Representatives without use of or knowledge of, the Confidential Information of the Disclosing Party; |
except that the above exceptions do not extend to circumstances where the Confidential Information is specific, does not fall within the above exceptions, and is embraced by more general information which does fall within the above exceptions.
| (a) | inform the Disclosing Party of the proposed disclosure as soon as possible, and if possible before the court or other public body orders the disclosure; |
| (b) | take into account reasonable requests of the Disclosing Party in relation to such disclosure; |
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| (c) | ask (or permit the Disclosing Party to ask as appropriate) the court or other public body to treat such Confidential Information as confidential; and |
| (d) | permit the Disclosing Party to make representations to the court or other public body in respect of the disclosure or confidential treatment of such Confidential Information. |
| (b) | For disclosure of the Confidential Information of the Disclosing Party to (i) those of its Representatives who reasonably require such access in connection with the performance of the obligations and enjoyment of the rights granted under this Agreement, and (ii) to actual or potential (sub)licensees, acquirers or assignees, collaborators, investment bankers, investors, or lenders (including in connection with any royalty factoring transaction), in both cases (i) and (ii), (A) have been informed of the confidential nature of such Confidential Information, the Disclosing Party’s interest in such Confidential Information, and the provisions of this Agreement, and have been instructed to comply with the applicable provision of Article 8 (Confidential Information) of this Agreement; and (B) are bound by legally binding confidentiality obligations to the Receiving Party on terms that are no less onerous than those set out in this Agreement, and which extend to such Confidential Information. The Receiving Party shall ensure that all those Representatives or other recipients who have access to the Confidential Information of the Disclosing Party comply with the provisions of this Agreement, and the Receiving Party shall be liable to the Disclosing Party for any acts or omissions of any such Representative or other recipients, that would, if effected by the Receiving Party, constitute a breach of this Agreement. |
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| 8.8 | Use of Name. Neither Party shall use the name of the other Party in any public disclosure, publicity or advertising involving the existence of this Agreement or its subject matter without the prior written approval of the other Party, unless otherwise permitted under this Article 8 (Confidential Information). |
| 8.10 | Subsequent Disclosures. Once information under this Agreement has been disclosed in accordance with this Article 8 (Confidential Information), subsequent disclosures of the same or similar information shall not require the notification or consent of the other Party. |
| 9.1 | Mutual Representations and Warranties. NextCure and Zaiming each represents and warrants to the other, as of the Effective Date, as follows: |
| (a) | Organization. It is duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement. |
| (b) | Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (i) in any material respect, any agreement to which such Party is bound, (ii) any requirement of any applicable law, or (iii) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party. |
| (c) | Binding Agreement. The Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles |
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| affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or in equity). |
| (d) | No Conflicts. It is not under any obligation, contractual or otherwise, to any person that conflicts with the terms of this Agreement. |
| (e) | Necessary Rights. Each Party has all the necessary rights, title and interest to grant the licenses hereunder. |
| (f) | No Debarment. Neither Party nor any of its Affiliates (i) has ever been debarred or subject to debarment or has received notice from the FDA of an intent to debar or has been convicted of a crime for which an entity or person could be debarred under 21 U.S.C. §335a; (ii) has ever been under indictment for a crime for which a person or entity could be debarred under 21 U.S.C. §335a; or (iii) or any of its personnel has been disqualified or is subject of a notice to disqualify as an investigator. |
| 9.2 | Additional Representations and Warranties of Zaiming. Zaiming further represents and warrants to NextCure, as of the Effective Date, as follows: |
| (a) | Zaiming Patent Rights. (i) All Zaiming Patent Rights in existence as of the Effective Date are listed in Schedule 1.1(jjjj), (ii) all such listed Zaiming Patent Rights have been and are being prosecuted and maintained diligently in the respective patent offices or other applicable governmental authorities in accordance with applicable law and Zaiming or its Affiliates are not in arrears with respect to any applicable fees in connection therewith, (iii) all inventor assignments with respect to inventions claimed or described in the Zaiming Patent Rights have been executed as necessary at each respective patent offices or applicable governmental authorities in accordance with applicable laws, and (iv) all issued Zaiming Patent Rights as of the Effective Date are, to ▇▇▇▇▇▇▇’s Knowledge, valid and enforceable. |
| (b) | No Claims. There are no claims, judgments or settlements against Zaiming pending, or to Zaiming’s Knowledge, threatened that invalidate or seek to invalidate any Zaiming Patent Rights. To Zaiming’s Knowledge, use of the Zaiming Know-How and Zaiming Patent Rights by NextCure in accordance with the terms of this Agreement, including NextCure’s further research, Development, Manufacturing or Commercialization or other Exploitation of Licensed Compounds and Licensed Products does not infringe on, misappropriate or violate the rights of any Third Party, including any Third Party Intellectual Property Rights. |
| (c) | No Conflict. Zaiming has not granted any right, license or interest in or to the Zaiming IP that is inconsistent with the licenses and rights granted to NextCure under this Agreement. |
| (d) | Ownership. Zaiming or its Affiliate, as applicable, is the sole and exclusive owner or otherwise Controls the Zaiming IP, and, in each case, has the ability to grant to NextCure the licenses and rights granted to NextCure under this Agreement, and such ownership is free and clear of all encumbrances, security interests, options and licenses. To ▇▇▇▇▇▇▇’s Knowledge, NextCure shall not be obligated to pay any payments to any Third Party to receive and exercise the licenses granted by ▇▇▇▇▇▇▇ under the Zaiming IP hereunder. |
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| (e) | Completeness. The Zaiming IP hereunder represents all of the Intellectual Property Rights that are Controlled by Zaiming or its Affiliates and are necessary or useful (i) for the research, Development, Manufacture and Commercialization or other Exploitation of the Zaiming Compounds or Zaiming Products in the Field in the NextCure Territory (or with respect to Development and Manufacturing, worldwide); or (ii) to use Zaiming ADC Platform Technology for the research, Development, Manufacture and Commercialization or other Exploitation of the NextCure Compounds or NextCure Products in the Field in the NextCure Territory (or with respect to Development and Manufacturing, worldwide). |
| (f) | No Litigation. There is no claim, action, suit, proceeding, complaint or investigation pending before any court or administrative office or agency or, currently threatened against Zaiming or any of its Affiliates, with respect to any of the Zaiming IP. |
| (g) | No Third Party Infringement. ▇▇▇▇▇▇▇ has not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any Zaiming IP nor have any such proceedings been threatened by ▇▇▇▇▇▇▇. To Zaiming’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate any of the Zaiming IP. |
| (h) | Assignment by Employees, Agents and Consultants. All employees and agents of, and consultants to, ▇▇▇▇▇▇▇ who have been involved in the creation or development of Zaiming IP are obligated to assign to Zaiming or its Affiliate, as applicable, their rights in and to any inventions arising out of their work at Zaiming with respect to Zaiming IP, either pursuant to written agreement or by operation of law. |
| (i) | Public or Philanthropic Funding. None of the Zaiming IP were supported in whole or in part by funding or grants by any governmental agency or philanthropic or charitable organization in any manner that would impose an obligation on NextCure, its Affiliates or any Sublicensee hereunder. |
| (j) | Disclosure. All information Zaiming has made available to NextCure relating to the Licensed Compounds is true and correct. ▇▇▇▇▇▇▇ has not disclosed, failed to disclose, or caused to be disclosed, any materials or other information that would reasonably be expected to cause the information that has been disclosed to be misleading. |
| (k) | Confidentiality. Zaiming has used Commercially Reasonable Efforts to protect the confidentiality of those parts of the Zaiming IP that constitute confidential or proprietary information of Zaiming. |
| (l) | Upstream Licenses. As of the Effective Date, there is no Upstream License of Zaiming. |
| 9.3 | Zaiming Covenant. |
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| generates any new payment or other obligation under any Upstream License of Zaiming that would apply to NextCure, except with NextCure’s prior consent (not to be unreasonably withheld, delayed or conditioned). If ▇▇▇▇▇▇▇ receives notification of any alleged breach of any Upstream License of Zaiming that, if an uncured actual breach, would give rise to the right of the relevant Upstream Licensor of Zaiming to terminate the relevant Upstream License of Zaiming, then Zaiming will promptly notify NextCure in writing of such alleged breach. If Zaiming or its Affiliate is the cause of the breach, then Zaiming shall use all reasonable efforts to cure such breach during the relevant cure period under the applicable Upstream License of Zaiming. |
| (b) | It will not, and will cause its Affiliates not to, incur or permit to exist any lien, encumbrance, charge, security interest, mortgage, liability, assignment, grant of license or other obligation with respect to the Zaiming IP which is or would be inconsistent with the terms and conditions of, including the grant of rights to NextCure under this Agreement, nor shall Zaiming assign its right, title or interest in or to any of Zaiming IP to any Third Party, unless assignment is subject to the licenses and other rights granted to NextCure under this Agreement. |
| 9.4 | Additional Representations and Warranties of NextCure. NextCure further represents and warrants to Zaiming, as of the Effective Date, as follows: |
| (a) | NextCure Patent Rights. (i) All NextCure Patent Rights in existence as of the Effective Date are listed in Schedule 1.1(ddd), (ii) all such listed NextCure Patent Rights have been and are being prosecuted and maintained diligently in the respective patent offices or other applicable governmental authorities in accordance with applicable law and NextCure or its Affiliates are not in arrears with respect to any applicable fees in connection therewith, (iii) all inventor assignments with respect to inventions claimed or described in the NextCure Patent Rights have been executed as necessary at each respective patent offices or applicable governmental authorities in accordance with applicable laws, and (iv) all issued NextCure Patent Rights as of the Effective Date are, to NextCure’s Knowledge, valid and enforceable. |
| (b) | No Claims. There are no claims, judgments or settlements against NextCure pending, or to NextCure’s Knowledge, threatened that invalidate or seek to invalidate any NextCure Patent Rights. To NextCure’s Knowledge, use of the NextCure Know-How and NextCure Patent Rights by Zaiming in accordance with the terms of this Agreement with respect to NextCure Antibody intended to be comprised in NextCure Compounds and NextCure Products, including Zaiming’s further research, Development, Manufacturing or Commercialization or other Exploitation of NextCure Compounds and NextCure Products does not infringe on, misappropriate or violate the rights of any Third Party with respect to NextCure Antibody intended to be comprised in NextCure Compounds and NextCure Products, including any Third Party Intellectual Property Rights. |
| (c) | No Conflict. NextCure has not granted any right, license or interest in or to the NextCure IP that is inconsistent with the licenses and rights granted to Zaiming under this Agreement. |
| (d) | Ownership. NextCure or its Affiliate, as applicable, is the sole and exclusive owner or otherwise Controls the NextCure IP, and, in each case, has the ability to grant to Zaiming the licenses and rights granted to Zaiming under this |
52
| Agreement, and such ownership is free and clear of all encumbrances, security interests, options and licenses. |
| (e) | No Litigation. There is no claim, action, suit, proceeding, complaint or investigation pending before any court or administrative office or agency or, currently threatened against NextCure or any of its Affiliates, with respect to any of the NextCure IP. |
| (f) | No Third Party Infringement. NextCure has not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any NextCure IP nor have any such proceedings been threatened by NextCure. To NextCure’s Knowledge, no person or entity is infringing or threatening to infringe or misappropriating or threatening to misappropriate any of the NextCure IP. |
| (g) | Assignment by Employees, Agents and Consultants. All employees and agents of, and consultants to, NextCure who have been involved in the creation or development of NextCure IP are obligated to assign to NextCure or its Affiliate, as applicable, their rights in and to any inventions arising out of their work at NextCure with respect to NextCure IP, either pursuant to written agreement or by operation of law. |
| (h) | Public or Philanthropic Funding. None of the NextCure IP were supported in whole or in part by funding or grants by any governmental agency or philanthropic or charitable organization in any manner that would impose an obligation on Zaiming, its Affiliates or any Sublicensee hereunder. |
| (i) | Disclosure. All information NextCure has made available to Zaiming relating to the NextCure Antibodies is true and correct. NextCure has not disclosed, failed to disclose, or caused to be disclosed, any materials or other information with respect to the NextCure Antibodies that would reasonably be expected to cause the information that has been disclosed to be misleading. |
| (j) | Confidentiality. NextCure has used Commercially Reasonable Efforts to protect the confidentiality of those parts of the NextCure IP that constitute confidential or proprietary information of NextCure. |
| (k) | Upstream Licenses. All Upstream License of NextCure existing as of the Effective Date are set forth in Schedule 1.1(cccc). No written notice of default or termination has been received or given by NextCure or its Affiliates under any Upstream License of NextCure, and to its Knowledge, there is no act or omission by NextCure or its Affiliates that would provide a right to terminate any Upstream License. |
| 9.5 | NextCure Covenant. |
| (a) | During the Term, NextCure shall remain in compliance in all material respects with each Upstream License of NextCure and shall not amend, modify, terminate, or waive compliance with (or consent to any of the foregoing) any material provision of any Upstream License of NextCure in a manner that would adversely affect Zaiming’s rights under this Agreement or increases or generates any new payment or other obligation under any Upstream License of NextCure that would apply to Zaiming, except with ▇▇▇▇▇▇▇’s prior consent (not to be unreasonably withheld, delayed or conditioned). If NextCure receives notification of any alleged breach of any Upstream License of |
53
| NextCure that, if an uncured actual breach, would give rise to the right of the relevant Upstream Licensor of NextCure to terminate the relevant Upstream License of NextCure, then NextCure will promptly notify Zaiming in writing of such alleged breach. If NextCure or its Affiliate is the cause of the breach, then NextCure shall use all reasonable efforts to cure such breach during the relevant cure period under the applicable Upstream License of NextCure. |
| (b) | It will not, and will cause its Affiliates not to, incur or permit to exist any lien, encumbrance, charge, security interest, mortgage, liability, assignment, grant of license or other obligation with respect to the NextCure IP which is or would be inconsistent with the terms and conditions of, including the grant of rights to Zaiming under this Agreement, nor shall NextCure assign its right, title or interest in or to any of NextCure IP to any Third Party, unless assignment is subject to the licenses and other rights granted to Zaiming under this Agreement. |
| 9.6 | Debarment. If, during the Term, a Party has reason to believe that it or any of its employees, officers, independent contractors, consultants or agents rendering services relating to the Licensed Compounds and Licensed Products: (i) is or will be debarred or convicted of a crime for which a person could be debarred under 21 U.S.C. §335a; (ii) is or will be under indictment for a crime for which a person could be debarred under 21 U.S.C. §335a; or (iii) has committed a wrongful act for which FDA would have grounds for invoking the Application Integrity Policy (AIP), then such Party shall immediately notify the other Party of same in writing. |
| 9.7 | Compliance with Anti-Corruption Laws. Notwithstanding anything to the contrary in the Agreement, each Party hereby covenants to each other that: |
| (b) | 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; |
| (c) | it shall, on request by the other Party, verify in writing that to the best of such Party’s knowledge, there have been no violations of Anti-Corruption Laws by such Party or persons employed by or subcontractors used by such Party in the performance of the Agreement, or shall provide details of any exception to the foregoing; and |
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| (d) | it shall maintain records (financial and otherwise) and supporting documentation related to the subject matter of the Agreement in order to document or verify compliance with the provisions of this Section 9.5 (Compliance with Anti-Corruption Laws), 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 9.5 (Compliance with Anti-Corruption Laws). 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, 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. |
| 9.8 | EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE 9 (REPRESENTATIONS AND WARRANTIES) OR ELSEWHERE IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EXCEPT AS SPECIFICALLY SET FORTH IN ARTICLE 9 (REPRESENTATIONS AND WARRANTIES), EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENT OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. THE PARTIES UNDERSTAND THAT THE LICENSED COMPOUNDS AND LICENSED PRODUCTS ARE THE SUBJECT OF ONGOING RESEARCH AND DEVELOPMENT AND NEITHER PARTY CAN ASSURE THAT ANY LICENSED COMPOUND OR LICENSED PRODUCT CAN BE SUCCESSFULLY DEVELOPED AND COMMERCIALIZED. |
| 10.1 | No Limitation on Certain Liabilities. Nothing in this Agreement shall exclude or limit, or purport to exclude or limit, a Party’s liability in the case of: |
| (a) | breach of Section 4.6 (Non-Competition) or Article 8 (Confidential Information); |
| (b) | fraud or fraudulent misrepresentation; |
| (c) | death or personal injury resulting from its gross negligence; or |
| (d) | any other matter in respect of which it would be unlawful to exclude or restrict liability. |
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| 10.3 | Indemnification. |
| (a) | not make any admission of liability, conclude any agreement in relation to such liability or make any compromise with any person, body or authority in relation to such liability without the prior written consent of the Indemnifying Party; and |
| (b) | have the right to participate in (but not control) the defence of a claim and to retain its own counsel in connection with such claim at its own expense. |
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| 10.5 | Insurance. Each Party shall obtain and maintain such types and amounts of insurance as is normal and customary for it to cover its activities under this Agreement, and will upon request by the other Party, provide the other Party with a certificate of insurance in that regard, along with any amendments and revisions thereto. |
| 11.2 | Termination. |
| (b) | Termination for Insolvency or Cessation of Business. To the extent permitted by applicable law, either Party may terminate this Agreement in its entirety if: |
| (i) | the other Party becomes insolvent, or is unable to pay its debts as they mature; |
| (ii) | an order is made, or a resolution is passed for the winding up of such other Party (other than voluntarily for the purpose of solvent amalgamation or reconstruction); |
| (iii) | a liquidator, administrator, administrative receiver, receiver, or trustee is appointed in respect of the whole or any part of such other Party’s assets or business; or |
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| (iv) | the other Party seeks relief or if proceedings are commenced against the other Party, or on its behalf, under any bankruptcy, insolvency or debtors’ relief law and those proceedings have not been vacated or set aside within thirty (30) Days after the commencement of those proceedings. |
| (d) | Termination by ▇▇▇▇▇▇▇. |
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| Sublicense. Furthermore, (x) any Patent Challenge asserted as a defence or counterclaim to an action first brought by Zaiming or any of its Affiliates or Sublicensees against NextCure or any of its Affiliates or Sublicensees, (y) a request for re-examination filed by NextCure of such Zaiming Patent Right or re-issuance of such Zaiming Patent Right after giving prior notice to Zaiming, to the extent that such actions are reasonably necessary or desirable to ensure adequate protection for Licensed Products; or (z) a Patent Challenge necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order, in each case, will not give rise to a right to terminate this Agreement by Zaiming under this Section 11.2(d)(ii) (Termination for Patent Challenge). |
| 11.3 | Rights in Bankruptcy. |
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| (b) | All rights, powers, and remedies of a licensee Party provided for in this Article 11 (Term and Termination) are in addition to and not in substitution for any and all other rights, powers, and remedies now or hereafter existing at law or in equity (including under the Code and any similar applicable laws in any other country). The Parties agree that they intend the following rights of a licensee Party to extend to the maximum extent permitted by law, including, for purposes of the Code in the event of a bankruptcy case of the licensor Party under the Code or any similar insolvency proceeding under any similar applicable laws, in each case subject to the licensee Party’s election to retain its rights as a licensee under Section 365(n) of the Code (or such similar applicable laws) and this Agreement, including continuing payments as provided thereby or hereunder: (i) the right of a complete duplicate or access to, as appropriate, any Zaiming IP or NextCure IP, as applicable (including all embodiments thereof), or, if any such Zaiming IP or NextCure IP, as applicable (or embodiments thereof) are not already in the licensor Party’s possession, any Third Party with whom the licensor Party contracts to perform an obligation of the licensor Party under this Agreement which is necessary for the Exploitation of the Licensed Compounds or Licensed Products in the Field; (ii) the right to contract directly with any Third Party described in paragraph (i) to complete the contracted work; and (iii) the right to cure any breach of the licensor Party under any such agreement with a Third Party if the licensor Party becomes incapable of curing, or refuses in writing to cure any such breach and the right to set off or recoup the costs thereof against amounts payable to the licensor Party under this Agreement. |
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| 11.5 | Effect of Termination. Upon termination of this Agreement, the following terms and conditions shall apply: |
| (b) | Sublicenses. |
| (i) | Solely in the event that this Agreement is terminated by Zaiming pursuant to Section 11.2(a) (Termination for Material Breach) for NextCure’s material breach, Section 11.2(b) (Termination for Insolvency or Cessation of Business) or Section 11.2(d) (Termination by Zaiming) or by NextCure pursuant to Section 11.2(a) (Termination for Material Breach) for Zaiming’s material breach or Section 11.2(b) (Termination for Insolvency or Cessation of Business), all Sublicenses of the Zaiming IP granted by NextCure prior to the effective date of termination of this Agreement shall, upon reasonable written request by the Sublicensee to Zaiming within thirty (30) Days after the effective date of termination of this Agreement, survive any such termination for a reasonable period of time during which Zaiming will enter into a new agreement with such Sublicensee for a direct license to the Terminated Products of substantially identical scope as the Sublicense granted by NextCure or its Affiliate on financial and other terms substantially identical to the corresponding terms in this Agreement (taking into consideration any differences in scope or territory between this Agreement and the applicable sublicense agreement), and such Sublicense shall terminate with respect to the Terminated Products upon the effective date of the direct license between Zaiming and the Sublicensee, provided that (x) such Sublicensee is then in material compliance with the applicable provisions of this Agreement and the terms and conditions of the applicable sublicense agreement, and (y) such Sublicensee agrees in writing to assume all applicable obligations of the NextCure under this Agreement, taking into consideration any differences in scope or territory between this Agreement and the applicable Sublicense agreement; and provided further that in no event will Zaiming be obligated to fulfill any of the NextCure’s obligations under such sublicense agreement other than those obligations of Zaiming contained in this Agreement. |
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| (ii) | Solely in the event that this Agreement is terminated by NextCure pursuant to Section 11.2(a) (Termination for Material Breach) for Zaiming’s material breach, Section 11.2(b) (Termination for Insolvency or Cessation of Business) or Section 11.2(c) (Termination for Convenience by NextCure) or by Zaiming pursuant to Section 11.2(a) (Termination for Material Breach) for NextCure’s material breach or Section 11.2(b) (Termination for Insolvency or Cessation of Business), all Sublicenses of the NextCure IP granted by Zaiming prior to the effective date of termination of this Agreement shall, upon reasonable written request by the relevant Sublicensee within thirty (30) Days after the effective date of termination of this Agreement, survive any such termination for a reasonable period of time during which NextCure will enter into a new agreement with such Sublicensee for a direct license to the Terminated Products of substantially identical scope as the Sublicense granted by Zaiming or its Affiliate on financial and other terms substantially identical to the corresponding terms in this Agreement (taking into consideration any differences in scope or territory between this Agreement and the applicable sublicense agreement), and such Sublicense shall terminate with respect to the Terminated Products upon the effective date of the direct license between NextCure and the Sublicensee, provided that (x) such Sublicensee is then in material compliance with the applicable provisions of this Agreement and the terms and conditions of the applicable sublicense agreement, and (y) such Sublicensee agrees in writing to assume all applicable obligations of the Zaiming under this Agreement, taking into consideration any differences in scope or territory between this Agreement and the applicable sublicense agreement; and provided further that in no event will NextCure be obligated to fulfil any of Zaiming’s obligations under such sublicense agreement other than those obligations of NextCure contained in this Agreement. |
| (c) | Assignment of Materials and License under NextCure IP. Unless this Agreement is partially terminated by Zaiming pursuant to Section 11.2(d)(i) (Termination for Convenience by Zaiming): |
| (ii) | Upon termination, NextCure shall, at Zaiming’s request, grant to Zaiming an exclusive license (with the right to sublicense in multiple |
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| (iii) | Consideration. The Parties agree that: |
| (A) | with respect to the NextCure Exclusive License Grant for the purpose of the Exploitation in Zaiming Territory of a Terminated Product that is a Zaiming Product, the license shall be royalty-free and no consideration for such NextCure Exclusive License Grant shall be required, unless this Agreement is terminated by NextCure for Zaiming’s material breach pursuant to Section 11.2(a) (Termination for Material Breach), in which case the license shall be royalty-bearing and the Parties will negotiate reasonable consideration for such NextCure Exclusive License Grant; |
| (B) | with respect to the NextCure Exclusive License Grant for the purpose of the Exploitation in NextCure Territory of a Terminated Product that is a Zaiming Product, the license shall be royalty-bearing and the Parties will negotiate reasonable consideration for such NextCure Exclusive License Grant, unless this Agreement is terminated by Zaiming for NextCure’s material breach pursuant to Section 11.2(a) (Termination for Material Breach), pursuant to Section 11.2(b) (Termination for Insolvency or Cessation of Business), pursuant to Section 11.2(d)(ii) (Termination for Patent Challenge), pursuant to 11.2(d)(iii) (Termination for Cessation of Development), or terminated by NextCure pursuant to Section 11.2(c) (Termination for Convenience by NextCure), in which cases the license shall be royalty-free and no consideration for such NextCure Exclusive License Grant shall be required; |
| (C) | with respect to the NextCure Exclusive License Grant for the purpose of the Exploitation in Zaiming Territory of a Terminated Product that is a NextCure Product, the license shall be royalty-free and no consideration for such NextCure Exclusive License Grant shall be required, unless this Agreement is terminated by NextCure for ▇▇▇▇▇▇▇’s material breach pursuant to Section 11.2(a) (Termination for Material Breach), by NextCure pursuant to Section 11.2(b) (Termination for Insolvency or Cessation of Business) or by Zaiming pursuant to Section 11.2(b) (Termination for Insolvency or Cessation of Business), in which cases the license shall be royalty-bearing and the Parties will negotiate reasonable consideration for such NextCure Exclusive License Grant; |
| (D) | with respect to the NextCure Exclusive License Grant for the purpose of the Exploitation in NextCure Territory of a Terminated Product that is a NextCure Product, the license shall be royalty-bearing and the Parties will negotiate reasonable consideration for such NextCure Exclusive License Grant, unless this Agreement is terminated by Zaiming for NextCure’s material breach pursuant to Section 11.2(a) (Termination for Material Breach), pursuant to |
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| Section 11.2(d)(ii) (Termination for Patent Challenge), or pursuant to Section 11.2(d)(iii) (Termination for Cessation of Development), in which cases the license shall be royalty-free and no consideration for such NextCure Exclusive License Grant shall be required; and |
| (E) | in the cases where the Parties shall negotiate the reasonable consideration under this Section 11.5(c)(iii) (Consideration), if after sixty (60) Days the Parties fail to agree on the amount of any consideration, either Party may submit such dispute for resolution in accordance with Section 12.4 (Expediated Arbitration). |
| (d) | Assignment of Materials and License under Zaiming IP. If this Agreement is terminated by Zaiming pursuant to Section 11.2(d)(i) (Termination for Convenience by Zaiming): |
| (i) | Section 11.5(c)(i) and 11.5(c)(ii) shall apply, mutatis mutandis so that NextCure may Exploit in Zaiming Territory a Terminated Product that is a NextCure Product, and the license granted by Zaiming to NextCure for such Exploitation shall be royalty-free and no consideration for such license shall be required. |
| (e) | Transfer of Inventory. Upon Zaiming’s request, Zaiming may procure any unsold or unused stocks of the Licensed Compounds or Licensed Products from NextCure. Such stocks shall be provided at a transfer price that equals NextCure’s cost of such stocks (as reflected on NextCure’s books and records used to prepare its financial statements). With respect to NextCure Products as Terminated Products, upon NextCure’s request, NextCure may procure any unsold or unused stocks of the NextCure Compounds or NextCure Products from Zaiming. Such stocks shall be provided at a transfer price that equals ▇▇▇▇▇▇▇’s cost of such stocks (as reflected on Zaiming’s books and records used to prepare its financial statements). All stocks shall be transferred to the possession of the procuring Party at FOB terms (Incoterms 2020). |
| 11.6 | Effect of Expiration or Termination for any Reason. |
| (a) | Accrued Rights. Expiry or termination of this Agreement will not affect any accrued rights or liabilities that either Party may have by the time expiration or termination takes effect. |
| (b) | Return of Confidential Information. Upon any termination of this Agreement pursuant to Section 11.2 (Termination), the Receiving Party shall return to the Disclosing Party any documents or other materials that contain the Disclosing Party’s Confidential Information in relation to the Terminated Compounds and Terminated Products, including all copies made, and make no further use or disclosure thereof. The Receiving Party may, however, keep copies of the Confidential Information of the Disclosing Party in its legal adviser’s files solely for the purpose of enabling it to comply with the provisions of this Agreement. For clarity, upon the termination of this Agreement, solely for the purpose of determining the confidentiality obligation under Article 8 (Confidential Information), all Confidential Information related to the Zaiming Products, to the extent they are Terminated Products, shall constitute Confidential Information of Zaiming, and all Confidential Information related to the NextCure Products, to the extent they are Terminated |
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| Products, shall constitute Confidential Information of the Party having the right to Exploit such Terminated Products after termination. |
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| serve as chair of the arbitration tribunal, such nomination to be made within thirty (30) Days after the selection of the second arbitrator. The arbitrators will be neutral and independent of both Parties and all of their respective Affiliates, will have significant experience and expertise in licensing and partnering agreements in the pharmaceutical industries, will have appropriate experience with respect to the matter(s) to be arbitrated, and will have some experience in mediating or arbitrating issues relating to such agreements. In the case of any dispute involving an alleged failure to use Commercially Reasonable Efforts, each arbitrator will in addition be an individual with experience and expertise in the worldwide Development and Commercialization of pharmaceuticals and the business, legal and scientific considerations related thereto. In the case of a dispute involving a scientific or accounting matter or determination, an expert having applicable expertise and experience will be selected by the Parties to assist the arbitrators in such scientific or accounting matter or determination (and the arbitrators will select such expert if the Parties cannot agree on such expert within thirty (30) Days following the selection of the arbitrators). |
| (c) | The arbitrators’ decision and award will be made and delivered within forty-five (45) Days after completion of the hearing described in Section 12.3(b). The determination of the arbitrators as to the resolution of any dispute will be binding and conclusive upon the Parties. All rulings of the arbitrators will be in writing and will be delivered to the Parties as soon as is reasonably possible. Nothing contained herein will be construed to permit the arbitrators to award punitive, exemplary or any similar damages. Any arbitration award may be entered in and enforced by a court in accordance with Section 12.5 (Award). |
| (a) | In any proceeding under this Section 12.4 (Expediated Arbitration), there will be one arbitrator selected by mutual agreement or, if the Parties are unable to agree on an arbitrator within five (5) Business Days after such matter is referred to Expedited Arbitration, the Parties will request that SIAC select the arbitrator, in each case satisfying the criteria set forth in Section 12.3(a) to the maximum extent possible. |
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| to the other Party’s Opening Brief (each, a “Response Brief”) which will not exceed ten (10) pages in total. The arbitrator will provide each Party’s Response Brief to the other Party after he or she receives a Response Brief from both Parties (or at the expiration of such ten (10) Business Day period if any Party fails to submit a Response Brief). |
| (c) | There will be no discovery in the Expedited Arbitration (e.g., document requests, interrogatories, depositions, etc.). The arbitrator will, however, have the right to perform independent research and analysis and to request any Party provide additional documentary evidence that was Controlled by such Party prior to the arbitrator making such request. |
| (d) | The arbitrator will be instructed to select one Party’s proposal no later than fifteen (15) Business Days following the receipt of both Parties’ Response Briefs (or expiration of the aforementioned 10 Business Day period if any Party fails to submit a Response Brief) and to select the proposal that he or she determines is the most commercially reasonable under the circumstances and best gives effect to the intent of the Parties under this Agreement. The arbitrator will accept only one of the proposals submitted by the Parties (without making any changes to such proposal) and will render such proposal as the arbitrator’s final decision. Notwithstanding anything to the contrary in this Agreement, the arbitrator will not have the authority to render any decision other than selecting one proposal submitted by a Party pursuant to this Section 12.4 (Expediated Arbitration). The arbitrator’s decision will be final and binding on the Parties. |
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| cure a material breach as permitted in accordance with Section 11.2(a) (Termination for Material Breach). |
| 12.9 | Survivability. Any duty to arbitrate under this Agreement will remain in effect and be enforceable after termination of this Agreement for any reason. |
| 13.1 | Governing Law. This Agreement shall be governed by and construed under the laws of New York, without giving effect to the conflicts of laws provision thereof. The United Nations Convention on Contracts for the International Sale of Goods (1980) shall not apply to the interpretation of this Agreement. |
| 13.2 | Amendment. The Agreement may only be amended in writing signed by duly authorized representatives of NextCure and Zaiming. |
| 13.3 | Assignment. |
| (a) | Subject to Section 13.3(b) and Section 13.3(c), neither Party may assign, mortgage, charge, or otherwise transfer any rights or obligations under this Agreement without the prior written consent of the other Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 13.3 (Assignment) will be null, void and of no legal effect. |
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| (d) | Subject to the exceptions expressly set forth in Section 6.1(c), NextCure’s obligation under Section 6.1(c) shall not be assigned to any person without the prior written consent of ▇▇▇▇▇▇▇. |
| 13.4 | Waiver. No failure or delay on the part of either Party to exercise any right or remedy under this Agreement shall be construed or operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude the further exercise of such right or remedy. |
| 13.5 | Invalid Clauses. If any provision or part of this Agreement is held to be invalid, amendments to this Agreement may be made by the addition or deletion of wording as appropriate to remove the invalid part or provision but otherwise retain the provision and the other provisions of this Agreement to the maximum extent permissible under applicable law such that the objectives contemplated by the Parties when entering into this Agreement may be realized. |
| 13.6 | No agency. Neither Party shall act or describe itself as the agent of the other, nor shall it make or represent that it has authority to make any commitments on the other’s behalf. Each Party will act solely as an independent contractor, and nothing in this Agreement will be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein will be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties. |
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| insurrections, riots, civil commotions, government actions, unavailability of supplies, materials or transportation, fire, earthquakes, floods, epidemics, pandemics, the spread of infectious diseases, and quarantines (“Force Majeure”). The affected Party will notify the other Party in writing of any Force Majeure circumstances as soon as reasonably practical, will provide a good faith estimate of the period for which its failure or delay in performance under this Agreement is expected to continue based on currently available information and shall use best efforts to mitigate the effects such Force Majeure and promptly resume performance upon the cessation thereof. |
For Zaiming: | [***] |
With copies, which shall not constitute notice to: | [***] |
For NextCure: | [***] |
With copies, which shall not constitute notice to: | [***] |
| 13.10 | Further Action. Each Party agrees to execute, acknowledge and deliver such further instruments, and do all reasonable further similar acts, as may be necessary or appropriate to carry out the purposes and intent of this Agreement. |
| 13.12 | Third Parties. The Agreement does not create any right enforceable by any person who is not a party to it except as otherwise expressly provided in Sections 10.3 (Indemnification) and 10.4 (Indemnification Procedure). Except as expressly provided in Sections 10.3 (Indemnification) and 10.4 (Indemnification Procedure), no person who is not a Party to this Agreement shall have the right to enforce any term of this Agreement. |
| 13.13 | Counterparts; Electronic Signatures. The Agreement may be executed in any number of counterparts, each of which is an original but all of which together will constitute one document. Each Party acknowledges and agrees that this Agreement and all schedules, related documents, amendments and modifications thereof, may be executed by electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature. Without limitation, “electronic signature” shall include faxed versions of an original signature |
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| or electronically scanned and transmitted versions (e.g., via pdf) of an original signature. |
---Signature Page Follows---
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The Agreement has been entered into on the Effective Date.
For and on behalf of | For and on behalf of |
Hainan Simcere Zaiming Pharmaceutical Co., Ltd. | |
/s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Signed | /s/ ▇▇▇▇▇▇▇ ▇▇▇▇ Signed |
Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ | Name: ▇▇▇▇▇▇▇ ▇▇▇▇ |
Title: President and Chief Executive Officer | Title: Chief Executive Officer |
Schedule 1.1(dd)
Development Plan for SIM0505
[***]
Schedule 1.1(ddd)
NextCure Patent Rights
[***]
Schedule 1.1(fff)
NextCure Product-Specific Patent Rights
[***]
Schedule 1.1(sss)
Research Plan for New ADC Targeting [***]
[***]
Schedule 1.1(cccc)
Upstream Licenses of NextCure
[***]
Schedule 1.1(ffff)
Description of Zaiming ADC Platform Technology
[***]
Schedule 1.1(gggg)
Description of SIM0505 (aka SCR-9359)
[***]
Schedule 1.1(jjjj)
Zaiming Patent Rights
[***]
Schedule 1.1(llll)
Zaiming Product-Specific Patent Rights
[***]
Schedule 2.4(a)
Technology Transfer Due by Zaiming
[***]
Schedule 8.9
Press Release
[***]