Exhibit 10.2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE AND CONFIDENTIAL.
NONEXCLUSIVE LICENSE AND DEVELOPMENT AGREEMENT
by and between GRITSTONE ONCOLOGY, INC.
on the one hand, and
GENEVANT SCIENCES GMBH
on the other hand
Dated as of January 15, 2021
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NONEXCLUSIVE LICENSE AGREEMENT
This NONEXCLUSIVE LICENSE AND DEVELOPMENT AGREEMENT (this
“Agreement”) is entered into as of January 15, 2021 (the “Effective Date”), by and between (a) Gritstone Oncology, Inc., a Delaware corporation having a place of business at 5959 Horton Street, Suite 300, Emeryville, California 94608, USA (“Gritstone”), on the one hand, and (b) Genevant Sciences GmbH, a limited liability company organized and existing under the laws of Switzerland, having an address of Viaduktstrasse 8, 4051 Basel, Switzerland (“Genevant”), on the other hand. Capitalized terms when used in this Agreement have the meanings set forth in Article I.
WHEREAS Genevant has expertise and intellectual property relating to, among other things, LNP (as defined below) formulations for delivery of nucleic acid (such as ribonucleic acid) and methods for manufacturing LNPs;
WHEREAS Gritstone has expertise and intellectual property relating to developing pharmaceutical products and methods based on the (i) identification and selection of disease- associated antigens to induce T cells or B cells by vaccination, (ii) therapeutic vaccine platforms including [***] (as defined below) and [***] (as defined below), (iii) research and GMP (as defined below) biomanufacturing capabilities and (iv) related technology;
WHEREAS Gritstone wishes to apply Genevant’s intellectual property to Develop and Commercialize Licensed Products in the Field in the Territory (each such term as defined below); and
WHEREAS Genevant desires to grant Gritstone certain nonexclusive (sub)licenses to its intellectual property upon the terms and subject to the conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt of which is hereby acknowledged, Gritstone and Genevant enter into this Agreement effective as of the Effective Date:
ARTICLE I – DEFINITIONS
“Affiliate” means, with respect to: (a) a Person (other than Genevant), any corporation, company, partnership, joint venture or firm that controls, is controlled by, or is under common control with such Person; or (b) Genevant, each of Genevant Sciences Ltd. And each of its direct and indirect wholly owned subsidiaries. For purposes of the foregoing sentence, “control” means
(a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, or (b) in the case of noncorporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such noncorporate entities.
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“Agreement” has the meaning set forth in the introductory paragraph.
“Agreement Activities” has the meaning set forth in Section 6.1(a)(iv).
“Alliance Manager” has the meaning set forth in Section 3.1(f).
“Applicable Laws” means all applicable laws, statutes, rules, regulations, guidelines, guidances, ordinances, orders, decrees, writs, judicial or administrative decisions and the like of any nation or government, any state or other political subdivision thereof, any entity exercising executive, judicial, regulatory or administrative functions of or pertaining to government (including any Governmental Authority), any tribunal or arbitrator of competent jurisdiction, and any trade organization whose regulations have the force of law.
“Boost” means a vaccine administered subsequent to administration of Prime vaccine. “Business Day” means any day that is not a Saturday, a Sunday, or other day that is a public
holiday in Basel, Switzerland, a provincial or national holiday in Vancouver, British Columbia, or a state or federal holiday in the State of New York.
“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
“Calendar Year” means a period of twelve (12) consecutive calendar months ending on December 31.
“[***]” means [***].
“Challenge” has the meaning set forth in Section 9.6.
“Challenge Notice” has the meaning set forth in Section 9.6.
“Change of Control” means, with respect to: (a) Gritstone, the occurrence of any of the following: (i) Gritstone consummates a merger, consolidation, stock sale or other similar transaction or series of transactions with anotherPerson pursuant to which: (A) the individuals and entities that were the beneficial owners of the outstanding voting securities of Gritstone immediately prior to such transaction do not beneficially own, directly or indirectly, more than fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the corporation or other entity resulting from such transaction(“Successor”) in substantially the same proportions as their ownership immediately prior to such transaction of such outstanding voting securities, or (B) less than fifty percent (50%) of the members of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of Gritstone at the time of the execution of the initial agreement for such transaction; provided, however, that a stock sale to underwriters of a public offering of Gritstone’s capital stock shall not constitute a Change of Control; or (ii) Gritstone enters into a sale or transfer of all or substantially all of its assets relating to this Agreement, other than to a Person that is an Affiliate of Gritstone prior to such transaction or series of transactions; and (b) Genevant, the occurrence of any of the following: (i) Genevant Parent consummates a merger, consolidation, stock sale or other similar transaction or series of transactions with another Person pursuant to which: (A) the individuals and entities that were the
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beneficial owners of the outstanding voting securities of Genevant Parent immediately prior to such transaction do not beneficially own, directly or indirectly, more than fifty percent (50%) of the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the Successor in substantially the same proportions as their ownership immediately prior to such transaction of such outstanding voting securities, or (B) less than fifty percent (50%) of themembers of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of Genevant Parent at the time of the execution of the initial agreement for such transaction; provided, however, that in no event shall the issuance of equity (or securities exchangeable or exercisable for or convertible into equity) ofGenevant Parent constitute a Change of Control; or (ii) Genevant enters into a sale or transfer of all or substantially allof its assets relating to this Agreement, other than to a Person that is an Affiliate of Genevant prior to such transaction or series of transactions.
“CMC” means chemistry, manufacturing, and controls, or Pharmaceutical Quality/CMC, as such terms are defined by the regulations of the applicable Regulatory Authority, including as required for Module 3 per International Conference on Harmonisation M4Q.
“CMO” means a Third Party contract manufacturing organization. “Collaboration Infringement” has the meaning set forth in Section 6.3(a).
“Commercialize” or “Commercialization” means any and all activities directed to marketing, promoting, distributing, importing, having imported, exporting, having exported, selling and having sold biologic or pharmaceutical products, including, subject to the terms of this Agreement, having Third Parties conduct such activities on behalf of the Person receiving the rights to Commercialize; provided that Manufacturing is not Commercializing.
“Commercial Milestone” has the meaning set forth in Section 4.4(a). “Commercial Milestone Payment” has the meaning set forth in Section 4.4(a).
“Commercially Reasonable Efforts” means, with respect to any particular activity or activities, the efforts and resources that would reasonably be used (including the promptness with which such efforts and resources would be applied) by a similarly situated company within the biopharmaceutical industry to execute such activity or activities in respect of a biologic or pharmaceutical product of similar market and profit potential and at a similar stage in development or product life as compared to the Product to which such activity or activities applies, taking into account, as applicable, its present and future market and commercial potential (including competitive market conditions, patent coverage, regulatory exclusivity, the size of the particular market in the applicable country for the relevant indication, actual and projected Development, Manufacturing and Commercialization costs, any issues regarding the ability to Manufacture or have Manufactured the Product; the likelihood of obtaining regulatory approvals and timing thereof; and the profitability of the relevant product or service in light of existing and anticipated competitive products and services, as well as pricing and reimbursement considerations) and all other relevant factors, including commercial, technical, legal, scientific, regulatory, or medical factors, including such Product’s efficacy, safety, stability, existing and anticipated approved labeling, and post-approval requirements, in each case in the applicable country, [***]. To the extent that the performance of a Party’s obligations hereunder is adversely affected by the other
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Party’s failure to perform its obligations hereunder, the impact of such other Party’s performance failure will be taken into account in determining whether such first Party has used its Commercially Reasonable Efforts to perform the affected obligations.
“Confidential Information” means all confidential information and confidential materials, patentable or otherwise, of a Party disclosed by or on behalf of such Party to the other Party before, on or after the Effective Date in connection with the discussions and negotiations pertaining to, or in the course of performing, this Agreement, including chemical composition of a formulation in LNPs, chemical substances, equipment, data, reports, Know-How, sources of supply, patent positioning, business plans, and also the proprietary and confidential information of Third Parties in possession of such Party under an obligation of confidentiality, whether or not related to making, using or selling a Product.
“Control,” “Controls” or “Controlled by” means, with respect to intellectual property, the possession of (whether by ownership or license, other than pursuant to this Agreement) the ability to grant access to, or a license or sublicense of, such intellectual property.
“Cover,” “Covers” or “Covered by” means, with respect to a product, that the making, using, selling, offering for sale or importing of such product, or the practice of a method with respect to the Manufacture or use of such product, would, but for (a) the licenses granted under this Agreement or (b) any statutory or common law research exemption, infringe a Valid Claim or a patent application (considering claims of patent applications to be issued) in the country in which such activity occurs.
“COVID mRNA Vaccine” means a product that both (a) contains an RNA that codes for one or more antigens of SARS-CoV-2 and (b) acts to stimulate the human immune system [***].
“Develop,” “Developing” or “Development” means any and all activities and studies required to develop biologic or pharmaceutical products for Marketing Authorization Approval or for Commercialization, including, subject to the terms of this Agreement, having Third Parties conduct such activities and studies on behalf of the Person receiving the rights to Develop; provided that Manufacturing is not Developing.
“Development Milestone” has the meaning set forth in Section 4.3. “Development Milestone Payment” has the meaning set forth in Section 4.3. “Development Milestone Table” has the meaning set forth in Section 4.3. “Disclosing Party” means the Party that discloses its Confidential Information. “Effective Date” has the meaning set forth in the introductory paragraph. “Efficacy Failure” has the meaning set forth in Section 9.4.
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“EMA” means the European Medicines Agency, a body of the European Union, or any successor agency(ies) thereof performing similar functions.
“EU” means (a) any country that is a member of the European Union as of the Effective Date and (b) the United Kingdom.
“EUA” means any form of “emergency use authorization” granted by the FDA in the United States, whether pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act or otherwise.
“EUA Achievement” means, with respect to a Product, that prior to receipt of U.S. MAA for such Product for the Field, Gritstone or any of its Affiliates or Sublicensees receives EUA for such Product for the Field; provided that, with respect to any Product for which there is EUA Achievement or U.S. MAA, no Improved Product with respect to such Product shall be deemed to have EUA Achievement unless prior thereto such Improved Product has been administered in a human clinical trial, whether alone or with any other product.
“EUA Sublicense Payment” has the meaning set forth in Section 4.3(c)(ii). “Evaluation License” has the meaning set forth in Section 2.1(b).
“Excluded Claim” means a dispute, controversy or claim that concerns (a) the construction, scope, validity, enforceability, inventorship or infringement of a patent, patent application, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
“Executive Officer” means, with respect to (a) Gritstone, Gritstone’s Chief Executive Officer or a substitute or replacement executive officer of Gritstone as to which Gritstone provides written notice to Genevant or (b) Genevant, the Chief Executive Officer of Genevant Sciences Corporation or a substitute or replacement executive officer of Genevant or an Affiliate thereof as to which Genevant provides written notice to Gritstone.
“Existing Third Party Agreements” means the [***].
“Extended Cure Period” has the meaning set forth in Section 9.2(a).
“FDA” means the Food and Drug Administration of the United States Department of Health and Human Services, or any successor agency(ies) thereof performing similar functions.
“[***]” means [***].
“Field” means the cure, treatment or prevention of the disease caused by SARS-CoV-2 and commonly referred to as COVID-19.
“First Commercial Sale” means, on a Product-by-Product and country-by-country basis, the first bona fide sale of such Product in such country to a nonSublicensee Third Party in an arm’s
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length transaction after Marketing Authorization Approval, or EUA, to market such Product in such country. Sales of a Product for registration samples, compassionate use sales, named patient use, intercompany transfers to Affiliates of a Party and the like shall not constitute a First Commercial Sale.
“FTE” means [***] hours of services per year by an employee or consultant.
“FTE Rate” means the fully burdened annualized rate established by the Parties for the services of an FTE, which, for the period beginning on the Effective Date and ending [***], is [***], subject to an annual increase beginning [***] by a percentage equal to the percentage increase in the Consumer Price Index for Canada (all items ) for the [***] month period ending with [***].
“GAAP” means U.S. generally accepted accounting principles as in effect from time to time, consistently applied.
“Generic Competition” means, on a Product-by-Product and country-by-country basis, that, in a given Calendar Quarter, (a) one or more Third Parties is selling a Generic Product with respect to such Product in such country and (b) Net Sales of such Product during [***] are less than [***] of the average Net Sales of such Product in such country during [***] immediately preceding [***] in which the first Generic Product is launched in such country.
“Generic Product” means, with respect to a Product and country, any product sold in such country by a Third Party (which may be called, for example and as applicable, a “biogeneric,” “follow-on biologic,” “follow-on biological product,” “follow-on protein product,” “interchangeable product,” “similar biological medicinal product,” or “biosimilar product”) that relied in whole or in part on the Marketing Authorization Approval for such Product as a basis for approval (or on any data submitted to the applicable Regulatory Authority in connection with the process to obtain such Marketing Authorization Approval), but excluding products licensed (or products with respect to which intellectual property is or has been licensed) by Gritstone or any of its Affiliates to such Third Party in such country.
“Genevant” has the meaning set forth in the introductory paragraph.
“[***]” means [***].
“Genevant Background IP” means any and all Genevant Know-How or Genevant Patents Controlled by Genevant or its Affiliates as of the Effective Date.
“Genevant Indemnitees” has the meaning set forth in Section 8.2. “Genevant IP” has the meaning set forth in Section 6.1(a)(iv).
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“Genevant Know-How” means any Know-How Controlled by Genevant or any of its Affiliates at the Effective Date or from time to time during the Term to the extent that it relates to LNPs, including: (a) the composition of matter of LNPs; (b) the method of use of LNPs; (c) LNP formulations for delivery of RNA; (d) the method of manufacturing LNPs, including the sourcing of components, assembly, or operation of LNP formulation instrumentation and reagents; or (e) the physical characteristics of LNPs, including the lipid or nonlipid components of LNPs (e.g., cationic lipid, PEG lipids, neutral lipids), particle morphology (e.g., electron dense or nonlamellar structure), and lipid ratios (e.g., molar ratios of the components). For clarity, no Genevant Patent is Genevant Know-How.
“Genevant LNP” means an LNP that is Covered by at least one (1) Genevant Patent or incorporates Genevant Know-How.
“Genevant Outside Foreground IP” means any and all Genevant Know-How or Genevant Patents created by Genevant or its Affiliates after the Effective Date other than in the performance of Agreement Activities.
“Genevant Parent” means Genevant Sciences Ltd., a Bermuda limited company. “Genevant Patent” means any Patent Controlled by Genevant or any of its Affiliates as of
the Effective Date or at any time during the Term to the extent that it includes one or more claims that Cover LNPs, including: [***].
“Genevant Patent Infringement” has the meaning set forth in Section 6.3(b). “Genevant Sole IP” has the meaning set forth in Section 6.1(e)(ii).
“Good Laboratory Practices” or “GLP” means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the International Conference on Harmonization.
“Good Manufacturing Practices” or “GMP” means the regulations set forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C (Drugs), Quality System Regulations and the requirements thereunder imposed by the FDA, and any comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the International Conference on Harmonization.
“Governmental Authority” means any United States or supra-national, foreign, federal, state, local, provincial, or municipal government, governmental, regulatory or administrative authority, agency, body, branch, bureau, instrumentality or commission or any court, tribunal, or judicial or arbitral body having relevant jurisdiction over a subject matter, including any Regulatory Authority.
“Gritstone” has the meaning set forth in the introductory paragraph.
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“Gritstone-Arbutus Agreement” means the License Agreement by and between Gritstone, on the one hand, and Arbutus Biopharma Corporation and Protiva Biotherapeutics Inc., on the other hand, dated as of October 16, 2017, as amended on July 20, 2018.
“Gritstone Background IP” means any and all Intellectual Property (including Payload IP) Controlled by Gritstone or any of its Affiliates as of the Effective Date that relates to any vaccination, [***], epitope prediction or identification, or vectors used in connection with the foregoing.
“Gritstone Indemnitees” has the meaning set forth in Section 8.1. “Gritstone IP” has the meaning set forth in Section 6.1(c).
“Gritstone Outside Foreground IP” means any and all Intellectual Property created by Gritstone or any of its Affiliates after the Effective Date other than in the performance of Agreement Activities.
“[***]” means [***].
“Gritstone Sole IP” has the meaning set forth in Section 6.1(e)(iii).
“Heterologous System” means [***].
“Homologous System” means [***]. For example, [***].
“Improved Product” means, [***].
“IND” or “Investigational New Drug Application” shall mean an investigational new drug application, or an analogous application required by a Governmental Authority anywhere in the world, required in order to conduct an initial clinical trial for the experimental form of a pharmaceutical product. For clarity, for purposes of this Agreement, a single IND encompasses both: (a) multiple IND numbers issued by the Governmental Authority when the subsequent IND numbers are issued for administrative convenience or other administrative purposes, and (b) all applications in jurisdictions outside the United States that involve substantially similar information as typically submitted in an IND submitted to the FDA.
“Indemnified Party” has the meaning set forth in Section 8.3. “Indemnifying Party” has the meaning set forth in Section 8.3. “Infringement Action” has the meaning set forth in Section 6.3(c).
“[***]” means [***].
“[***]” means [***].
“[***]” means [***].
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“Insolvent Party” has the meaning set forth in Section 9.7(a). “Intellectual Property” means Patents and Know-How. “JAMS Rules” has the meaning set forth in Section 10.7(c). “Joint IP” has the meaning set forth in Section 6.1(e)(iv). “Joint Patent” means any Patent that Covers Joint IP.
“JSC” has the meaning set forth in Section 3.1(a).
“Know-How” means biological materials and other tangible materials, information, data, inventions, practices, methods, methodologies, protocols, formulas, formulations, oligonucleotide sequences, knowledge, trade secrets, processes, assays, skills, techniques and results of experimentation and testing, patentable or otherwise.
“Knowledge Parties” means [***].
“Licensed Intellectual Property” means any and all Genevant Patents and Genevant Know-
How.
“LNP” means lipid nanoparticle (excluding encapsulated drug, such as Payload(s)), components of lipid nanoparticles, and methods of manufacturing lipid nanoparticles, including (i) the composition of matter of lipid nanoparticle(s), (ii) the physical characteristics of lipid nanoparticle(s), including the lipid or nonlipid components of lipid nanoparticle(s) or (iii) lipid ratios (i.e., ratios of the lipid components within a formulation). For clarity, “LNPs” means one or more LNP, and “LNP” does not include Payload(s).
“[***]” means [***].
“Losses” has the meaning set forth in Section 8.1.
“Major Markets” means [***].
“Manufacture” or “Manufacturing” means, with respect to a Product or its components (including LNPs), all activities associated with the production, manufacture and processing of such Product, and the filling, finishing, packaging, labeling, shipping, and storage of such product, including formulation process scale-up for GLP toxicology and clinical study use, aseptic fill and finish, stability testing, analytical development, quality assurance and quality control, and the production of the bulk finished dosage form of such Product in compliance with GMP. For clarity, Manufacture includes the manufacture of LNPs for the sole purpose of the formulation and manufacture of Products.
“Manufacturing Know-How” means, with respect to a Product or its components (including LNPs) (a) all Know-How used by Genevant and its Affiliates (or their respective
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contractors) necessary to Manufacture such Product (including manufacturing, process engineering, SOPs, documents relating to the production process, data, information and results (e.g., batch records, deviation reports, in process tracking and trending data, analytical testing, development and validation reports, vendor audits, etc.) relating to the production process); and
(b) any other Know-How that is necessary to Manufacture such Product in compliance with GMP, including the identity, amounts and assurance quality of ingredients, the manufacturing processes and controls, specifications, technology, inventions, assays, quality control and testing procedures, and batch records.
“Manufacturing Facility” has the meaning set forth in Section 3.4(a).
“Marketing Authorization Approval” or “MAA” means, with respect to any country or region, any registration, license, approval or authorization from any Regulatory Authority required to market a Product in such country or region, including any pricing or reimbursement approval required by Applicable Laws to obtain such registration, license, approval or authorization, excluding any EUA.
“Necessary Third-Party IP” means with respect to any country in the Territory and any Product, on a country-by-country basis, any issued Patent owned or controlled by a Third Party in such country that would be infringed [***] by the exploitation of Licensed Intellectual Property to Develop, Manufacture or Commercialize such Product in such country in the absence of a license. For clarity, “Necessary Third-Party IP” excludes [***].
“Net Sales” means the gross amount [***] on sales or other dispositions in the Territory of a Product during a Royalty Payment Term to Third Parties [***], less:
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x
Net Sales shall be determined from books and records maintained in accordance with GAAP or other applicable accounting standards. Nothing herein shall prevent [***] from selling, distributing or invoicing any Product at a discounted price to Third Parties in connection with clinical studies, compassionate or named patient sales, or an indigent program or similar bona fide arrangements in which such party agrees to forego a normal profit margin for good faith business reasons. To the extent that [***] receives any consideration other than monies for the sale of Products, Net Sales shall include the fair market value of such consideration. For the avoidance of doubt, neither (i) the supply of a Product free of charge nor (ii) the transfer of a Product between [***] for resale shall be included in the computation of Net Sales, but, in the case of clause (ii), the subsequent resale of such Product by [***] to a Third Party shall be included within the computation of Net Sales.
If a Product is formulated, packaged or sold with one or more other active ingredients or products for a single price (a “Combination Product”), the Net Sales of the Product shall be calculated for each applicable [***] by multiplying the Net Sales (as determined without reference to this paragraph) of the Combination Product by the fraction A/(A+B), where A is the average gross selling price in the applicable country of the Product(s) when sold separately in finished form, and B is the average gross selling price in the applicable country of the other active ingredient(s) or product(s) included in the Combination Product when sold separately in finished form, in each case for the most recent period in which sales of both occurred. If the Product(s) is/are sold as part
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of a Combination Product and is/are sold separately in finished form, but the other product(s) included in the Combination Product are not sold separately in finished form, the Net Sales of the Product shall be determined by multiplying the Net Sales of the Combination Product by the fraction A/C, where: A is the average gross selling price in the applicable country of the Product(s) contained in such Combination Product when sold separately, and C is the average gross selling price in the applicable country of the Combination Product. If the Product(s) is/are sold as part of a Combination Product and is/are not sold separately in finished form, but the other product(s) included in the Combination Product are sold separately in finished form, the Net Sales of the Product shall be determined by multiplying the Net Sales of the Combination Product by the fraction C-B/C, where: B is the average sale price of the other product(s) included in such Combination Product when sold separately, and C is the average sale price of the Combination Product. If, on a country-by-country basis, the Product component is not sold separately in that country, Net Sales for the Combination Product shall be calculated by multiplying actual Net Sales of the Combination Product by the fraction D/(D+E), where D is the fair market value of the portion of the Combination Product that contains the Product and E is the fair market value of the portion of the Combination Product containing the other active ingredient(s) included in such Combination Product, as such fair market values are determined by [***].
The foregoing analysis shall be conducted on a country-by-country basis as reasonably required to determine relative fair market values of the relevant Combination Product components.
“Notice of Dispute(s)” has the meaning set forth in Section 10.7(b).
“[***]” means any and all viruses constituting [***], including, for clarity, the following [***] and any and all species of [***] constituting any of the foregoing.
“Party” means Genevant or Gritstone, and “Parties” means Genevant and Gritstone. “Patent” means any patent (including any reissue, extension, substitution, confirmation, re-
registrations, re-examination, revival, supplementary protection certificate, patents of addition, continuation, continuation-in-part, or divisional) or patent application (including any provisional application, nonprovisional patent application, continuation, continuation-in-part, divisional, PCT international applications or national phase applications), in each case whether in the United States or any foreign country.
“Payload(s)” means one or more RNA contained in a Product that is proprietary to Gritstone or its licensees or sublicensees (including any Sublicensees) and encodes [***].
“Payload IP” means Intellectual Property [***].
“Payload Material” has the meaning set forth in Section 3.3(a).
“Permitted Contractor” means a Third Party (e.g., a contractor or consultant) that performs activities for which Gritstone is responsible under this Agreement under a bona fide contract services arrangement; provided, however, that Gritstone shall not appoint any [***] as a Permitted Contractor without Genevant’s prior written consent (which consent may be granted or withheld in Genevant’s sole discretion).
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“Person” means an individual, corporation, limited liability company, syndicate, association, trust, partnership, joint venture, unincorporated organization, government agency or any agency, instrumentality or political subdivision thereof, or other entity.
“Phase I Study” means a human clinical study of a Product conducted in healthy volunteers or patients under the same or substantially similar protocol or IND, as each may be amended or supplemented, in any country, that generally provides for the first introduction into humans of such Product and the primary purpose of which is obtaining data regarding any or all of safety, metabolism, pharmacokinetic properties and clinical pharmacology and, potentially, to gain early evidence on effectiveness, as described in or contemplated by U.S. 21 C.F.R. 312.21(a).
“Phase II Study” means a human clinical study (including any safety run-in to such clinical study, which for clarity shall be considered part of the same clinical study and not a separate clinical study) of a Product conducted in healthy volunteers or patients with a particular disease or condition under the same or substantially similar protocol or IND, as each may be amended or supplemented, in any country, following completion of one or more Phase I Studies of such Product and with a principal purpose of evaluating the effectiveness, safety, or acceptable dose range for such Product for a particular use, as described or contemplated by 21 C.F.R. §312.21(b).
“Phase III Study” means a human clinical study (including any safety run-in to such clinical study, which for clarity shall be considered part of the same clinical study and not a separate clinical study) of a Product that: (a) is (i) conducted in patients with a particular disease or condition in any country, (ii) conducted under the same or substantially similar protocol or IND, as each may be amended or supplemented, in any country that would satisfy the requirements of
U.S. 21 C.F.R. Part 312.21(c) and (iii) intended to evaluate the benefit-risk relationship of such Product in a defined patient population that provides, alone or together with other clinical studies, an adequate basis of data to support a Marketing Authorization Approval (or EUA); or (b) is a human clinical study that (i) Gritstone or any of its Affiliates refers to publicly in a press release issued, or a filing with the Securities and Exchange Commission, by Gritstone or any of its Affiliates or Sublicensees, as a (or as a potential) “Phase III,” “pivotal” or “registration” study or
(ii) supports a Marketing Authorization Approval (or EUA), in each case (clauses (a) and (b)) even if denominated as a Phase II study.
“Prime” means the initial vaccine that precedes the Boost vaccine. “Proceeds” has the meaning set forth in Section 6.3(h).
“Product” means a COVID mRNA Vaccine (a) containing [***] and (b) where [***]; provided that Product does not include any product that can be used for treatment or prevention of a [***] in a human.
“Product IP” means (a) all Product Patents and (b) all Product-specific Know-How, including for clarity nonclinical and clinical data.
“Product Patents” means all Patents that [***].
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“R&D Budget” has the meaning set forth in Section 3.2. “R&D Support Plan” has the meaning set forth in Section 3.2.
“Receiving Party” means the Party that receives Confidential Information of the other
Party.
“Record Retention Period” has the meaning set forth in Section 4.7(b).
“Regulatory Authority” means any federal, national, multinational, state, provincial or
local regulatory agency, department, bureau or other governmental entity anywhere in the world with authority over the Development, Manufacture or Commercialization of a Product under this Agreement. The term “Regulatory Authority” includes the FDA, the EMA, the European Commission and relevant national competent authorities in the EU member states.
“Research” or “Researching” means identifying, evaluating, validating and optimizing products prior to readiness to conduct pre-IND GLP toxicology studies thereon.
“RNA” means ribonucleic acid, and includes, for clarity, mRNA. “Royalty” has the meaning set forth in Section 4.5.
“Royalty Payment Term” means, on a Product-by-Product and a country-by-country basis, the term beginning on the First Commercial Sale of such Product in such country and ending on the later of (a) the date of the last to expire Valid Claim that exists in such country that would be infringed by the commercial making, using, offering for sale or selling of such Product in such country absent the license grants in this Agreement; and (b) [***] from the date of First Commercial Sale of such Product in such country.
“Safety Failure” has the meaning set forth in Section 9.4.
“SARS-CoV-2” means the coronavirus (severe acute respiratory syndrome coronavirus 2 of the genus Betacoronavirus) that is the causative agent of the disease commonly referred to as COVID-19.
“[***]” means [***].
“Specified Licenseholder” means, [***].
“Solvent Party” has the meaning set forth in Section 9.7(a). “Sublicense” has the meaning set forth in Section 2.2.
“Sublicense Event” means [***].
“Sublicense Revenue” means [***].
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“Sublicensee” means a Third Party to whom Gritstone has granted a Sublicense under Section 2.2, but excluding any wholesaler or distributor based on a wholesaler or distributor arrangement for the sale of Product, or any contract research organization or manufacturer providing research, development or manufacturing services to Gritstone or any of its Affiliates or Sublicensees (even if such entity is granted a right or license to make (but not to sell) Product).
“Term” means the term described in Section 9.1. “Territory” means worldwide.
“Third Party” means any Person other than Genevant, Gritstone and their respective Affiliates.
“Third-Party Claim” has the meaning set forth in Section 8.3.
“Third-Party Financial Terms” has the meaning set forth in Section 4.9. “Third-Party License” has the meaning set forth in Section 4.9. “Upfront Payment” has the meaning set forth in Section 4.1.
“U.S. Approval Date” means, with respect to each Product, the date that U.S. Marketing Application Approval for such Product occurs.
“U.S. Bankruptcy Code” has the meaning set forth in Section 9.7(b).
“U.S. Marketing Application” means, with respect to any product, an application to commercially distribute, sell or market such product in the United States, including any of: a new drug application, supplemental new drug application, biologics license application, or supplemental biologics license application; a successor application to any of the foregoing in the United States; or a supplement or amendment to any of the foregoing. For clarity, U.S. Marketing Application expressly excludes a request or application for EUA.
“U.S. Marketing Application Approval” or “U.S. MAA” means, with respect to any product, the granting or approval by the FDA of a U.S. Marketing Application for such product. For clarity, (a) a U.S. Marketing Application Approval is also a Marketing Authorization Approval and (b) U.S. Marketing Application Approval expressly excludes EUA.
“Valid Claim” means a claim of an issued and unexpired Genevant Patent or Joint Patent, which claim has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which is not appealable or has not been appealed within the time allowed for appeal, and which has not been abandoned, disclaimed, denied, or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.
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ARTICLE II - LICENSE GRANTS
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ARTICLE III - SCOPE OF COLLABORATION
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ARTICLE IV - FINANCIAL PROVISIONS
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Development Milestone | Development Milestone Payment | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
[***] | [***] | |||
|
| |||
| [***] | |||
| [***] | [***] | [***] | [***] |
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[***] | [***] | [***] | [***] | [***] |
For clarity: [***]. Gritstone shall provide written notice to Genevant of the occurrence of each Development Milestone within [***] of its occurrence and pay the corresponding Development Milestone Payment to Genevant within [***] after delivery of an invoice from Genevant therefor.
Notwithstanding the foregoing:
For clarity, [***].
*the [***] to achieve this Development Milestone shall [***], but [***]”
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Commercial Milestone | Commercial Milestone Payment |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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[***] | [***] |
[***]
provided that, notwithstanding the foregoing, with respect to any Product:
Following expiry of the Royalty Payment Term in respect of any Product or country (x) the licenses granted by Genevant to Gritstone with respect to such Product and country become fully paid-up, sublicensable (subject to Section 2.2), royalty-free, exclusive, transferable, perpetual and irrevocable licenses, and (y) the obligation of Gritstone to pay any Royalty or Commercial Milestones with respect to sales of such Product in such country shall terminate.
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ARTICLE V - ADDITIONAL OBLIGATIONS
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(a) all Product-specific nonclinical and clinical data and reports, including those arising from clinical trials conducted for any Product, and (b) all Marketing Authorization Approvals and applications therefor, including INDs, biologics license applications and other regulatory filings, related thereto.
(b) Genevant shall (i) cooperate in reasonable respects with such Regulatory Authority during such inspection or audit, (ii) reasonably update Gritstone during (in the case of multi-day inspections or audits) and following such inspection or audit of any information relating to Products, (iii) promptly provide to Gritstone the inspection or audit observations of such Regulatory Authority relating to such activities or data; provided that Genevant shall have the right to redact any material from such inspection or audit observations that do not relate to the Products, (iv) prepare the response to any such observations, (v) provide a copy of such planned response to Gritstone to the extent it relates to a Product, shall consult with Gritstone concerning the response of Genevant to each such communication and, if such response affects the Product specifications or any Marketing
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Authorization Approval (or Gritstone’s obligations to comply with any legal requirements), such response shall be subject to Gritstone’s approval, and (vi) conform its activities under this Agreement to any commitments made in such response. To the extent reasonably practicable and not otherwise prohibited by Applicable Laws or any contractual obligation to a Third Party, Genevant shall permit Gritstone the opportunity to be present on site during (but not directly participate in) any such inspection.
ARTICLE VI - INTELLECTUAL PROPERTY
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(y) Genevant or its Affiliates alone or (z) Gritstone jointly with Genevant or its Affiliates, and (B) constitute an improvement, enhancement or derivative of Gritstone Background IP, Payload IP or, solely in the case of clause (A)(x) above, Gritstone Outside Foreground IP and neither (x) also constitute an improvement, enhancement or derivative of any Genevant Background IP or, except in the case of clause (A)(x) above, Genevant Outside Foreground IP nor (y) are otherwise directed to LNPs; and
“Gritstone IP”).
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(ii) Gritstone shall not file a Patent that includes any claims directed to any Genevant IP or Genevant Sole IP, in each case without the other Party’s prior written consent.
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(ii) then, if the Infringement Action is initiated and maintained by: (A) Gritstone, [***]; or (B) Genevant, [***].
(i) For clarity, [***].
ARTICLE VII - CONFIDENTIAL INFORMATION AND PUBLICITY
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(b) is subsequently disclosed to the Receiving Party or its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
(c) is or otherwise becomes generally available to the public or enters the public domain, either before or after it is disclosed to the Receiving Party, and such public availability is not the result, directly or indirectly, of any fault of, or improper taking, use or disclosure by, the Receiving Party or its Affiliates or anyone working in concert or participation with the Receiving Party or its Affiliates; or (d) except for Product IP, has been independently developed by employees or contractors of the Receiving Party or its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party. Notwithstanding the foregoing, (i) specific Confidential Information disclosed by a Disclosing Party shall not be deemed to be within any exceptions set forth in (a), (b), or (c) above merely because it is embraced by more general information to which one or more of those exceptions may apply, (ii) no combination of information shall be deemed to be within any such exceptions unless the combination itself and its principle of operation are within the public domain and (iii) disclosure of Confidential Information to Regulatory Authorities shall not constitute a public disclosure (i.e., it shall remain Confidential Information after such disclosure), unless such information is made available to the public by the Regulatory Authority. Even though Confidential Information may be within one of the exceptions described in the preceding sentence, the Receiving Party shall not disclose to Third Parties that the excepted Confidential Information was received from the Disclosing Party.
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ARTICLE VIII - INDEMNIFICATION
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ARTICLE IX - TERM AND TERMINATION
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In addition, with respect to any Product for which Gritstone has obtained a Marketing
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Authorization Approval in any country prior to Genevant’s receipt of notice of termination, Gritstone shall be allowed to continue to commercialize such Product in such country, whether on its own or through Third Parties, to the extent manufactured prior to the effective date of such termination, for up to [***] from such date, subject to payment to Genevant of the Royalty and any and all other amounts hereunder payable with respect to sales of such Product.
ARTICLE X - MISCELLANEOUS
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(i) such assignment to an Affiliate shall not relieve such Party of its obligations herein, and (ii) in each case, the assigning Party shall provide the other Party with written notice of such assignment or transfer within [***] after such assignment or transfer. Any purported transfer or assignment in contravention of this Section 10.4.1 shall, at the option of the nonassigning Party, be null and void and of no effect. This Agreement shall be binding upon and inure to the benefit of the Parties and their permitted successors and assigns.
Notices to Gritstone shall be addressed to:
[***]
Notices to Genevant shall be addressed to:
[***]
With a copy to (which shall not constitute notice):
[***]
Either Party may change its address by giving notice to the other Party in the manner provided in this Section 10.5. Any notice required or provided for by the terms of this Agreement shall be in writing and shall be (a) sent by certified mail, return receipt requested, postage prepaid, (b) sent via a reputable international express courier service, or (c) sent by electronic transmission, with a copy by regular mail. The effective date of the notice shall be the actual date of receipt by the
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receiving party.
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(c) Gritstone shall promptly provide to Genevant a copy of the filing receipt or other written confirmation of such filing.
[Signature Page Follows]
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IN WITNESS WHEREOF, authorized representatives of Gritstone and Genevant have executed and delivered this Agreement effective as of the Effective Date.
GRITSTONE ONCOLOGY, INC.
By: /s/ Andrew R. Allen
Name: Andrew R. Allen
Title: President & CEO
GENEVANT SCIENCES GMBH
By:
Name:
Title:
IN WITNESS WHEREOF, authorized representatives of Gritstone and Genevant have executed and delivered this Agreement effective as of the Effective Date.
GRITSTONE ONCOLOGY, INC.
By: Name:
Title:
GENEVANT SCIENCES GMBH
By: /s/ Dr. Markus Rohrwild
Name: Dr. Markus Rohrwild
Title: Managing Director
Exhibit A
[***]
A-1
Exhibit B
[***]
B-1
Exhibit C
[***]
C-54
Exhibit D Genevant Patents
[***]
D-1
[[[[[***]
January 5, 2021
CONFIDENTIAL
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