Case 1:22-cv-02229-MKV Document 45-1 Filed 10/04/22 Page 1 of 65
`Case 1:22-cv-02229-MKV Document 45-1 Filed 10/04/22 Page 1 of 65
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`EXHIBIT A
`EXHIBIT A
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`EX-10.17
`EX-10.17 19 d635330dex1017.htm EX-10.17
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`Exhibit 10.17
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`THE SYMBOL “[***]” DENOTES PLACES WHERE CERTAIN IDENTIFIED
`INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i)
`NOT MATERIAL, AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE
`COMPANY IF PUBLICLY DISCLOSED
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`LICENSE AND CO-DEVELOPMENT AGREEMENT
`
`THIS LICENSE AGREEMENT (“Agreement”) is made as of July 4, 2018 (“Effective Date”), by and between BioNTech RNA
`Pharmaceuticals GmbH, a corporation organized and existing under the laws of Germany (“BioNTech”), having its principal place of business at An
`der Goldgrube 12, 55131 Mainz, Germany, and Genevant Sciences GmbH, a corporation organized and existing under the laws of Switzerland
`(“Genevant”), having an address of Viaduktstrasse 8, 4051 Basel, Switzerland. BioNTech and Genevant are referred to individually as a “Party” and
`collectively as the “Parties.”
`
`RECITALS
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`WHEREAS, Genevant has an exclusive license to certain intellectual property rights relating to RNA-based therapeutics enabled by lipid
`nanoparticle delivery technologies;
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`WHEREAS, BioNTech is developing certain mRNA payloads for treatment in the field of oncology and infectious diseases and is also
`developing alone and in collaboration with third parties certain formulations useful for the delivery of mRNA payloads;
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`WHEREAS, the Parties wish to jointly develop pharmaceutical products that combine the best mRNA payloads with the best lipid nanoparticle
`technology in the fields of rare diseases and liver diseases, under the terms and conditions set forth herein; and
`
`WHEREAS, BioNTech wishes to obtain from Genevant a license to utilize the lipid nanoparticle delivery technologies in conjunction with its
`development of mRNA payloads and delivery technologies in the oncology field, and Genevant is willing to grant such license to BioNTech, all under
`the terms and conditions set forth herein.
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`NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the receipt and sufficiency which
`are hereby acknowledged, BioNTech and Genevant hereby agree as follows.
`
`ARTICLE 1
`DEFINITIONS
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`Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized, shall have the meanings set forth below, or the
`meaning as designated in the indicated places throughout this Agreement.
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`1.1 “Accounting Standards” means internationally recognized accounting principles (including IFRS, US GAAP, and the like), in each case, as
`then in effect and as consistently applied by the applicable Party or its Affiliate or Sublicensee.
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`1.2 “Affiliate” means, (a) with respect to Genevant, any Person that, directly or indirectly through one or more intermediaries is controlled by
`Genevant Sciences Ltd., but for only so long as such control exists; and (b) with respect to BioNTech, any Person that, directly or indirectly through one
`or more intermediaries, controls, is controlled by, or is under common control with BioNTech, but for only so long as such control exists. For the
`purpose of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under common control”) means (a) to possess,
`directly or indirectly, the power to direct the management
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`or policies of an entity, whether through ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or
`(b) direct or indirect beneficial ownership of more than fifty percent (50%) of the voting share capital or other equity interest in such entity.
`Notwithstanding the above, for purposes of this Agreement, [***] and its Affiliates will not be deemed to be Affiliates of Genevant, and AT Impf
`GmbH, having its place of business at Rosenheimer Platz 6, 81669 Munich, Germany, and any person or entity that, during the Term, directly or
`indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with AT Impf GmbH (other than BioNTech AG or
`any person or entity that is directly or indirectly controlled by BioNTech AG) shall not be considered an Affiliate of BioNTech.
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`1.3 “Alliance Manager” has the meaning set forth in Section 3.5 (Alliance Managers).
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`1.4 “Allowable Expenses” has the meaning set forth in Exhibit F.
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`1.5 “Applicable Laws” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes,
`rules, regulations, administrative codes, guidances, ordinances, judgments, decrees, directives, injunctions, orders, permits (including MAAs) of or from
`any court, arbitrator, Regulatory Authority or Governmental Authority having jurisdiction over or related to the subject item.
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`1.6 [***] means [***].
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`1.7 “[***] Agreement” means the April 11, 2018, Cross License Agreement by and between Genevant Sciences Ltd. and [***].
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`1.8 “Auditor” has the meaning set forth in Section 8.8 (Audit Dispute).
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`1.9 “BioNTech Development Milestone Plan” has the meaning set forth in Section 4.2.
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`1.10 “BioNTech Field” means the treatment, prevention and diagnosis of illnesses in the field of oncology.
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`1.11 “BioNTech Indemnitees” has the meaning set forth in Section 15.1 (Indemnification by Genevant).
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`1.12 “BioNTech Joint Inventions” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
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`1.13 “BioNTech Joint Patents” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
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`1.14 “BioNTech Know-How” means all Know-How that BioNTech Controls as of the Effective Date or during the Term that is necessary or
`reasonably useful for the Development, Manufacture or Commercialization of: (a) any BioNTech Product in the BioNTech Field; and/or (b) any
`Co-Development Product in the Co-Development Field. BioNTech Know-How includes BioNTech Joint Inventions, BioNTech Sole Inventions and
`BioNTech’s interest in Co-Owned Joint Inventions.
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`1.15 “BioNTech mRNA Payloads” means the five (5) mRNA payloads created by BioNTech and the [***] identified in Exhibit A. The Parties
`agree that Exhibit A will include [***] mRNA payloads at the time of execution of this Agreement. Within twelve (12) months from execution of this
`Agreement, BioNTech may propose [***] additional mRNA payloads to be included in the BioNTech mRNA Payloads and [***] the proposal made by
`BioNTech, [***]. Upon written agreement by the Parties to such final mRNA payload, Exhibit A will be updated to include such mRNA payload.
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`1.16 “BioNTech Patents” means all Patents that BioNTech Controls as of the Effective Date or during the Term that are necessary or reasonably
`useful for the Development, Manufacture or Commercialization of: (a) any BioNTech Product in the BioNTech Field; and/or (b) any Co-Development
`Product in the Co-Development Field. BioNTech Patents includes BioNTech Joint Patents BioNTech’s interest in Co-Owned Joint Patents. A list of
`BioNTech Patents existing as of the Effective Date is attached as Exhibit H. While the Parties intend Exhibit H to be exhaustive, the failure to list a
`Patent on Exhibit H will not exclude it from the definition of BioNTech Patents if it otherwise meets the definition provided herein.
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`1.17 “BioNTech Product” means any pharmaceutical product that contains a BioNTech mRNA Payload encapsulated within a LNP (irrespective
`of whether such LNP is Contolled by Genevant or BioNTech).
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`1.18 “BioNTech Product Infringement” has the meaning set forth in Section 11.4(a) (Notice).
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`1.19 “BioNTech Product Manufacturing Know-How” means Genevant Know-How that is necessary or reasonably useful to Manufacture any
`BioNTech Product in the BioNTech Field.
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`1.20 “BioNTech Product Pharmacovigilance Agreement” has the meaning set forth in Section 5.4 (Pharmacovigilance).
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`1.21 “BioNTech Product Supply Agreement” has the meaning set forth in Section 6.1 (Manufacture of BioNTech Products).
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`1.22 “BioNTech Products Collaboration Plan” has the meaning set forth in Section 4.4 (Conduct of Development Activities by Genevant).
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`1.23 “BioNTech Sole Inventions” means any Inventions made solely by BioNTech’s or its Affiliates’ employees, agents or independent
`contractors.
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`1.24 “BioNTech Technology” means the BioNTech Know-How and the BioNTech Patents.
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`1.25 “Blocker Entity” has the meaning set forth in Section 16.5(b) (Taxes of Co-Entrepreneurship).
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`1.26 “Board of Directors” has the meaning set forth in Section 1.49(a) (Competitor Change of Control).
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`1.27 “Business Day” means a day other than a Saturday, Sunday or a bank or other public holiday in Mainz, Basel or New York.
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`1.28 “Calendar Quarter” means each respective period of three (3) consecutive months ending on March 31, June 30, September 30, and
`December 31.
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`1.29 “Calendar Year” means each respective period of twelve (12) consecutive months ending on December 31.
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`1.30 “CFR” means the U.S. Code of Federal Regulations.
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`1.31 “Claims” means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise)
`for losses, damages, legal costs and other expenses of any nature.
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`1.32 “CMC” means chemistry, Manufacturing, and controls.
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`1.33 “CMO” means contract Manufacturing organization.
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`1.34 “Code” has the meaning set forth in Section 3.3 (JSC Decision-Making).
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`1.35 “Co-Development Field” means the treatment, prevention and diagnosis of liver diseases (as defined by the FDA and/or the EMA),
`excluding any oncology diseases.
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`1.36 “Co-Development Joint Inventions” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
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`1.37 “Co-Development Joint Patents” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
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`1.38 “Co-Development mRNA Payloads” means the six (6) mRNA payloads to be created by BioNTech in the Co-Development Field and the
`[***] identified in Exhibit B of which five (5) will be selected for Development as part of Co-Development Products.
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`1.39 Co-Development Product” means any pharmaceutical product that contains a Co-Development mRNA Payload encapsulated within a
`Genevant LNP and/or, if agreed between the Parties in the JSC, within another LNP.
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`1.40 “Co-Development Product Development Plan” has the meaning set forth in Section 9.2.
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`1.41 “Co-Development Product Commercialization Plan” has the meaning set forth in Section 10.2 (Commercialization Plan and Report).
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`1.42 “Co-Development Product Infringement” has the meaning set forth in Section 11.4(a) (Notice).
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`1.43 “Co-Development Product Pharmacovigilance Agreement” has the meaning set forth in Section 9.10 (Co-Development Product
`Pharmacovigilance).
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`1.44 “Co-Development Product Supply Agreement” has the meaning set forth in Section 9.11 (Manufacturing Responsibilities).
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`1.45 “Combination Product” means any product containing (i) at least one Product and (ii) at least one additional active ingredient that is not a
`Product.
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`1.46 “Commercialization” means the conduct of all activities undertaken before and after Regulatory Approval relating to the promotion,
`marketing, sale and distribution (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling and delivering
`products to customers) of products, including: (a) sales force efforts, detailing, advertising, medical education, planning, marketing, sales force training,
`and sales and distribution; and (b) scientific and medical affairs. For clarity, Commercialization does not include any Development activities, whether
`conducted before or after Regulatory Approval. “Commercialize” and “Commercializing” have correlative meanings.
`
`1.47 “Commercially Reasonable Efforts” means, with respect to an entity’s obligations under this Agreement relating to BioNTech Products or
`Co-Development Products, those efforts and resources that are consistent with the exercise of customary scientific and business practices as applied in
`the pharmaceutical industry for a company of a similar stage and size as the entity and having similar resources (viewed in relation to such Party and all
`of its Affiliates plus, in the case of Genevant, [***] (applying that term to [***] mutatis mutandis as with respect to Genevant)) for Development,
`regulatory, Manufacturing and Commercialization activities conducted with respect to products at a similar stage of Development or Commercialization
`and having similar commercial potential, taking into account relative safety and efficacy, product profile, the regulatory environment, payors’ policies
`and regulations, competitiveness of the marketplace and the market potential of such products, the nature and extent of market exclusivity, including
`patent coverage and regulatory data protection, price and reimbursement status, and all other relevant commercial, technical, legal, scientific, regulatory,
`or medical factors.
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`1.48 “Competitor” means any of the competitive entities identified and separately agreed to in writing by the Parties or their Affiliates (applying
`that term mutatis mutandis to such entity).
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`1.49 “Competitor Change of Control” shall be deemed to have occurred if any of the following occurs after the Effective Date:
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`(a) any Competitor (i) becomes the beneficial owner, directly or indirectly, of shares of capital stock or other interests (including
`partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election
`of the directors, managers or similar supervisory positions (“Voting Stock”) of such Party representing more than fifty percent (50%) of the total voting
`power of all outstanding classes of Voting Stock of such Party or (ii) has the power, directly or indirectly, to appoint a majority of the Party’s managing
`directors or to elect a majority of the members of the Party’s board of directors, supervisory board or similar governing body (“Board of Directors”); or
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`(b) such Party enters into a merger, consolidation or similar transaction with a Competitor (whether or not such Party is the surviving
`entity) and as a result of such merger, consolidation or similar transaction (i) the managing directors or the members of the Board of Directors of such
`Party immediately prior to such transaction constitute less than a majority of the
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`managing directors or the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (ii) the
`Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to
`beneficially own, directly or indirectly, shares of Voting Stock of such Party representing a majority of the total voting power of all outstanding classes
`of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such
`transaction; or
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`(c) such Party sells or transfers to a Competitor, in one or more related transactions, properties or assets representing all or substantially all
`of such Party’s consolidated total assets to which this Agreement relates.
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`Notwithstanding the foregoing, the occurrence of neither of the following shall, by itself, be considered a Change in Control, the sale of capital
`stock of a Party in an initial public offering on an internationally recognized securities exchange, including the NYSE, NASDAQ, London Stock
`Exchange, Frankfurt Stock Exchange, and Hong Kong Stock Exchange shall not constitute a Competitor Change of Control if entered into in the
`ordinary course of business and not for the purpose or effect of circumventing any other Party’s rights hereunder.
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`1.50 “Confidential Information” of a Party means all Know-How, unpublished patent applications and other information and data of a financial,
`commercial, business, operational or technical nature of such Party that is disclosed or made available by or on behalf of such Party or any of its
`Affiliates to the other Party or any of its Affiliates, whether made available orally, in writing or in electronic or other form. The terms of this Agreement
`are the Confidential Information of both Parties. All Inventions made under this Agreement will constitute the Confidential Information of the party that
`owns such Inventions as set forth in Section 11.1 (Ownership). All other data and results generated under this Agreement in relation to BioNTech
`Products shall constitute Confidential Information of BioNTech, and all other data and results generated under this Agreement in relation to
`Co-Development Products shall constitute Confidential Information of both Parties.
`
`1.51 “Control” or “Controlled” means, with respect to any Know-How, Patent or other intellectual property rights, that a Party has the legal
`authority or right (whether by ownership, license or otherwise, other than by virtue of any license granted to such Party by the other Party pursuant to
`this Agreement) to grant a license, sublicense, access or other right (as applicable) under such Know-How, Patent, or other intellectual property rights to
`the other Party on the terms and conditions set forth herein, in each case without breaching the terms of any agreement with a Third Party.
`
`1.52 “Develop” or “Development” means to develop (including clinical, non-clinical and CMC development), analyze, test and conduct
`preclinical, clinical and all other regulatory trials for a product, including all post-approval clinical trials, as well as all related regulatory activities and
`any and all activities pertaining to new indications, pharmacokinetic studies and all related activities including work on new formulations, new methods
`of treatment, and CMC activities including new Manufacturing methods. “Developing” and “Development” have correlative meanings.
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`1.53 “Development Costs” means FTE Costs and Out-of-Pocket Costs incurred by the Parties and their Affiliates in Developing the
`Co-Development Products in the Co-Development Field, in each case to the extent incurred in accordance with this Agreement and the budget approved
`by the JSC as follows:
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`(a) all Out-of-Pocket Costs and FTE Costs incurred for activities specified in the Co-Development Product Development Plan including
`the FTE Costs of scientific, medical, technical and other personnel directly engaged in performing Development activities under the Co-Development
`Product Development Plan, which costs shall be determined based on time actually spent performing the applicable activities, unless another basis is
`otherwise agreed in advance by the Parties in writing;
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`(b) all Out-of-Pocket Costs and FTE Costs in connection with any Manufacturing activities for pre-clinical or clinical supplies as set forth
`in the Co-Development Product Development Plan, including (i) the Manufacturing Expenses for the Co-Development mRNA Payloads, Genevant
`LNPs, and Co-Development Products; (ii) costs and expenses incurred to purchase or package Third Party comparator or Third Party combination drugs
`or devices; and (iii) costs and expenses of disposal of clinical samples;
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`(c) all Out-of-Pocket Costs and FTE Costs incurred in connection with Regulatory Filings with respect to Co-Development Products in the
`Co-Development Field;
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`(d) all Out-of-Pocket Costs and FTE Costs associated with [***] commitments mandated by Governmental Authorities, to the extent
`incurred with respect to Co-Development Products;
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`(e) all Out-of-Pocket Costs and FTE Costs identifiable to establishing, updating and maintaining a global safety database for
`Co-Development Products;
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`(f) all Out-of-Pocket Costs and FTE Costs associated with companion and in vitro diagnostics, if applicable to the Development of a
`Co-Development Product; and
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`(g) any other Out-of-Pocket Costs and FTE Costs incurred that are explicitly included in the budget under the Co-Development Product
`Development Plan approved by the JSC.
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`Development Costs shall exclude all Allowable Expenses, capital expenditures not previously agreed to by the Parties as part of the Co-Development
`Product Development Plan, and any other cost not included in Development Costs, including by way of example, costs attributable to general corporate
`activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial
`reporting and other overhead unless otherwise agreed to in writing by the Parties. For the avoidance of doubt, Development Costs do not include
`Out-of-Pocket Costs, FTE Costs, or other amounts that are attributable and allocable to post-approval commercialization studies other than as specified
`in (d) above.
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`1.54 “Development Reconciliation Procedures” has the meaning set forth in Section 9.12(b) (Development Costs Reports).
`
`1.55 “Direct Expenses” means, with respect to Co-Development mRNA Payload, Genevant LNP, BioNTech Products or Co-Development
`Products, those material and services expenses captured in invoices and the like which are specifically attributable to Manufacture of the
`Co-Development mRNA Payload, Genevant LNP, BioNTech Product or Co-Development Product, including expenses of raw materials, Manufacturing
`supplies, solvents, containers, container components, packaging, labels and other printed materials used in production.
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`1.56 “Disclosing Party” has the meaning set forth in Section 12.1(a) (Duty of Confidence - subsection (a)).
`
`1.57 “Dollar” means U.S. dollars, and “$” shall be interpreted accordingly.
`
`1.58 “EMA” means the European Medicines Agency or any successor entity thereto.
`
`1.59 “Excluded Claim” has the meaning set forth in Section 16.10(f) (Dispute Resolution - subsection (f)).
`
`1.60 “Executive Officers” has the meaning set forth in Section 3.3 (JSC Decision-Making).
`
`1.61 “FDA” means the United States Food and Drug Administration or any successor entity thereto.
`
`1.62 “First Commercial Sale” means, (a) with respect to any BioNTech Product in any country or jurisdiction in the Territory, the first arm’s
`length sale of such BioNTech Product by BioNTech, its Affiliates or Sublicensees to a Third Party for distribution, use or consumption in such country
`or jurisdiction after Regulatory Approval has been obtained for such BioNTech Product in such country or jurisdiction; and (b) with respect to any
`Co-Development Product in any country or jurisdiction in the Territory, the first arm’s length sale of such Co-Development Product by a Party, its
`Affiliates or Sublicensees to a Third Party for distribution, use or consumption in such country or jurisdiction after Regulatory Approval has been
`obtained for such Co-Development Product in such country or jurisdiction.
`
`1.63 “FTE” means a full day of work by one employee recorded in the conduct of the specified activities.
`
`1.64 “FTE Costs” means the product of: (a) that number of FTEs (proportionately, on a per-FTE basis) used by a Party or its Affiliates in directly
`performing activities assigned to such Party under and in accordance with the Co-Development Product Development Plan or the BioNTech Products
`Collaboration Plan, multiplied by (b) the applicable FTE Rate.
`
`1.65 “FTE Rate” means [***].
`
`1.66 “Genevant Indemnitees” has the meaning set forth in Section 15.2 (Indemnification by BioNTech).
`
`1.67 “Genevant Joint Inventions” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
`
`1.68 “Genevant Joint Patents” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
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`1.69 “Genevant Know-How” means all Know-How that Genevant Controls as of the Effective Date or during the Term that is necessary or
`reasonably useful for the Development,
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`Manufacture or Commercialization of: (a) any BioNTech Product in the BioNTech Field; or (b) any Co-Development Product in the Co-Development
`Field. Genevant Know-How includes Genevant Sole Inventions, Genevant Joint Inventions, and Genevant’s interest in Co-Owned Joint Inventions.
`
`1.70 “Genevant LNP” means the LNP delivery platform Controlled by Genevant. The Parties will identify during Development of the BioNTech
`Products and/or Co-Development Products which part(s) of the Genevant LNP will be used in the BioNTech Products and/or Co-Development Products
`in accordance with the terms of this Agreement.
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`1.71 “Genevant Patents” means all Patents in the Territory that Genevant Controls as of the Effective Date or during the Term that are necessary
`or reasonably useful for the Development, Manufacture or Commercialization of: (a) any BioNTech Product in the BioNTech Field; or (b) any
`Co-Development Product in the Co-Development Field. Genevant Patents include Genevant Joint Patents, and Genevant’s interest in Co-Owned Joint
`Patents. A list of Genevant Patents existing as of the Effective Date is attached as Exhibit G. While the Parties intend Exhibit G to be exhaustive, the
`failure to list a Patent on Exhibit G will not exclude it from the definition of Genevant Patents if it otherwise meets the definition provided herein.
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`1.72 “Genevant Sole Inventions” means any Inventions made solely by Genevant’s or its Affiliates’ employees, agents or independent
`contractors.
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`1.73 “Genevant Technology” means the Genevant Know-How and Genevant Patents.
`
`1.74 “Government Authority” means any federal, state, national, state, provincial or local government, or political subdivision thereof, or any
`multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police,
`regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral
`body).
`
`1.75 “Incremental Withholding Taxes” has the meaning set forth in Section 16.5(b) (Tax Cooperation).
`
`1.76 “IND” means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application
`or submission for approval to conduct human clinical investigation filed with or submitted to a Regulatory Authority in conformance with the
`requirements of such Regulatory Authority.
`
`1.77 “Indemnified Party” has the meaning set forth in Section 15.3 (Indemnification Procedure).
`
`1.78 “Indemnifying Party” has the meaning set forth in Section 15.3 (Indemnification Procedure).
`
`1.79 “Indirect Expenses” means, with respect to either a BioNTech Product or Co-Development Product, labor expenses, including allocated
`FTE expenses for personnel directly involved in the Manufacturing the Co-Development mRNA Payload, Genevant LNP, BioNTech Products or
`Co-Development Products in accordance with GMP requirements such as production, quality control, quality assurance, microbiology, and other similar
`departments as needed and to the extent such personnel participate directly in the production of the Co-Development mRNA
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`Case 1:22-cv-02229-MKV Document 45-1 Filed 10/04/22 Page 11 of 65
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`EX-10.17
`Payload, Genevant LNP, BioNTech Product or Co-Development Product and components thereof, and other indirect production expenses such as a
`reasonable allocation of expenses associated with a either Party’s Manufacturing of Co-Development mRNA Payload, Genevant LNP, BioNTech
`Product or Co-Development Product, including facility costs and personnel costs directly supporting the Manufacturing of the Co-Development mRNA
`Payload, Genevant LNP, BioNTech Product or Co-Development Product in accordance with GMP requirements, including labor for and indirect
`expenses of quality control, quality assurance, raw material acquisition and acceptance, microbiology, document control, calibration/validation, and
`expenses for process development and analytical methods development, but excluding, in each case, any Direct Expenses.
`
`1.80 “Initiation” means, with respect to a clinical trial, the first dosing (whether with investigational drug, comparator drug or placebo) of the
`third subject in such clinical trial.
`
`1.81 “Initial BioNTech Product Manufacturing Know-How” has the meaning set forth in Section 6.3(a) (BioNTech Product Initial
`Manufacturing Know-How).
`
`1.82 “Invention” shall mean any process, method, composition of matter, article of Manufacture, discovery or finding, patentable or otherwise,
`that is made, generated, conceived or otherwise invented as a result of a Party exercising its rights or carrying out its obligations under this Agreement,
`whether directly or via its Affiliates, agents or independent contractors, including all rights, title and interest in and to the intellectual property rights
`therein.
`
`1.83 “Joint Inventions” means any Inventions that are made jointly by one or more employees, agents or independent contractors of one Party or
`its Affiliates and one or more employees, agents or independent contractors of the other Party or its Affiliates.
`
`1.84 “Joint Patent Committee” or “JPC” has the meaning set forth in Section 11.1(c) (Joint Patent Committee).
`
`1.85 “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.1 (Joint Steering Committee).
`
`1.86 “Know-How” means any information, including discoveries, improvements, modifications, processes, methods, techniques, protocols,
`formulas, data, inventions, know-how, trade secrets and results, patentable or otherwise, including physical, chemical, biological, toxicological,
`pharmacological, safety, and pre-clinical and clinical data, dosage regimens, control assays, and product specifications, but excluding any Patents.
`
`1.87 “Lead Commercialization Party” has the meaning set forth in Section 10.1.
`
`1.88 “LNP” means lipid nanoparticle.
`
`1.89 “Manufacture” or “Manufacturing” means performing all steps of the manufacturing of any BioNTech mRNA Payload, Co-Development
`mRNA Payload, Genevant LNP, BioNTech Products or Co-Development Products, including: (a) acquisition, testing and release of raw materials,
`excipients or active pharmaceutical ingredients and stability testing; (b) manufacturing and filling; (c) in-process quality control testing; (d) labeling and
`packaging; (e) final quality release; and (f) storage prior to shipping and the related controls.
`
`
`10
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`https://www.sec.gov/Archives/edgar/data/1776985/000119312519241112/d635330dex1017.htm
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`10/102
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`Case 1:22-cv-02229-MKV Document 45-1 Filed 10/04/22 Page 12 of 65
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`EX-10.17
`1.90 “Manufacturing Transfer” has the meaning set forth in Section 6.4 (Manufacturing Transfer).
`
`1.91 “MAA” or “Marketing Authorization Application” means an application to the appropriate Regulatory Authority for approval to market a
`product (but excluding Pricing Approval) in any particular jurisdiction and all amendments and supplements thereto, including an NDA filed with the
`FDA in the U.S.
`
`1.92 “Manufacturing Expenses” means (a) with respect to a Co-Development mRNA Payload, BioNTech P