Amended and Restated Collaboration and License Agreement by and among Vir Biotechnology, Inc. and Alnylam Pharmaceuticals, Inc. dated as of March 7, 2025

EX-10.2 2 a20250331-q1ex102amendedan.htm EX-10.2 Document
Exhibit 10.2


CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.







AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT
by and among
VIR BIOTECHNOLOGY, INC.
and
ALNYLAM PHARMACEUTICALS, INC.
dated as of March 7, 2025


Execution Version
AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT
THIS AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of March 7, 2025 (the “Restatement Effective Date”), by and among Vir Biotechnology, Inc., a Delaware corporation, having a place of business at 1800 Owens Street, San Francisco, CA 94158 (“Vir Bio”), and Alnylam Pharmaceuticals, Inc., a Delaware corporation, having a place of business at 675 West Kendall Street, Cambridge, Massachusetts 02142, USA (“Alnylam”).
INTRODUCTION
1.Vir Bio and Alnylam entered into that certain Collaboration and License Agreement, effective as of October 16, 2017, as amended by Letter Agreement dated November 13, 2018 and by Amendment No. 1 to the Collaboration and License Agreement effective December 17, 2019, Amendment No. 2 to the Collaboration and License Agreement effective March 3, 2020, Amendment No. 3 to the Collaboration and License Agreement effective April 1, 2020, and Letter Agreement dated December 23, 2020 (collectively, the “Original Agreement”) pursuant to which Alnylam granted Vir Bio licenses to research, develop and commercialize RNAi products for certain infectious disease targets;
2.Alnylam and Vir Bio hereby agree to restate the Original Agreement in order for Vir Bio to further research, develop and commercialize only HBV Licensed Products (as defined below);
3.Alnylam desires to grant licenses to such technology to Vir Bio, and the Parties desire to collaborate on certain development activities, in each case upon the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the respective representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which are hereby acknowledged, Alnylam and Vir Bio agree as follows:
1.DEFINITIONS. For the purpose of this Agreement, the following terms, whether used in singular or plural form, shall have the respective meanings set forth below:
1.1Accounting Period” shall have the meaning set forth in Section 4.8.
1.2Acquired Party” shall have the meaning set forth in Section 3.7.
1.3Acquirer” shall have the meaning set forth in Section 3.7.
1.4Achievement of Human POC” shall mean that the Parties reasonably determine that the results from such POC Study support the continuation of preparation and conduct of a Phase II Study and that [***] based on the results of such POC Study.
1.5Additional Alnylam In-Licenses” shall have the meaning set forth in the Original Agreement.
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1.6Affiliate” shall mean any Person who directly or indirectly controls or is controlled by or is under common control with another Person. For purposes of this definition, “control” or “controlled” shall mean, with respect to a Person, (a) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by such Person; (b) any corporation or business entity which, directly or indirectly, owns, controls or holds fifty percent (50%) (or the maximum ownership interest permitted by Law) or more of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of such Person; or (c) any corporation or business entity, of which fifty percent (50%) or more of the securities or other ownership interests representing the equity of such corporation or business entity is directly or indirectly owned, controlled or held by the same corporation, business entity or security holders, or holders of ownership interests, that own, control or hold fifty percent (50%) or more of the securities or other ownership interests representing the equity or the voting stock of such Person.
1.7Agreement” shall have the meaning set forth in the Preamble, and shall include, for the avoidance of doubt, all Exhibits and Schedules attached hereto.
1.8ALN-HBV” shall mean an siRNA Controlled by Alnylam, comprising the siRNA [***], as further described on Schedule B.
1.9ALN-HBV02” shall mean an siRNA Controlled by Alnylam, comprising the siRNA [***], as further described on Schedule B.
1.10Alnylam” shall have the meaning set forth in the Preamble.
1.11Alnylam Collaboration IP” shall mean (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Alnylam or its Affiliates and Controlled by Alnylam at any time during the Term, in each case in the conduct of the Collaboration or otherwise under this Agreement, and (b) any Patent Rights that claim such improvements, discoveries or Know-How. Alnylam Collaboration IP excludes Alnylam’s interest in Joint Collaboration IP. Patent Rights constituting Alnylam Collaboration IP are either Alnylam Core Technology Patent Rights or Alnylam Product-Specific Patent Rights, as the case may be.
1.12Alnylam Core Technology Patent Rights” shall mean Patent Rights Controlled by Alnylam at any time during the Term that are reasonably necessary or useful to Develop, Manufacture or Commercialize HBV Licensed Products, in each case other than Alnylam Product-Specific Patent Rights and Patent Rights comprising Joint Collaboration IP. Alnylam Core Technology Patent Rights includes the Patent Rights set forth on Schedule C-1 (as of the Restatement Effective Date) and may include Patent Rights that constitute Alnylam Collaboration IP.
1.13Alnylam In-Licenses” shall mean (a) the Existing Alnylam In-Licenses and (b) any agreement between Alnylam (or its Affiliates) and a Third Party entered into after the Effective Date pursuant to which Alnylam acquires Control of Know-How or Patent Rights that are reasonably necessary or useful to Develop, Manufacture or Commercialize HBV Licensed Products in the Field in the Territory (excluding any Unlicensed Component of a Combination Product), but in the case of any such agreement described in clause (b), solely to the extent that such agreement is designated as an Alnylam In-License pursuant to Section 3.6(b).
1.14Alnylam Indemnitees” shall have the meaning set forth in Section 9.1(a).
1.15Alnylam Intellectual Property” shall mean collectively, Alnylam Know-How, Alnylam Patent Rights, Alnylam Collaboration IP and Alnylam’s interest in Joint Collaboration IP.
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1.16Alnylam Know-How” shall mean Know-How Controlled by Alnylam at any time during the Term that is reasonably necessary or useful to Develop, Manufacture and/or Commercialize HBV Licensed Products in the Field in the Territory.
1.17Alnylam Patent Rights” shall mean Alnylam Core Technology Patent Rights and Alnylam Product-Specific Patent Rights.
1.18Alnylam Product-Specific Patent Rights” shall mean, with respect to an HBV Licensed Product, Patent Rights Controlled by Alnylam at any time during the Term that solely claim (a) (i) an siRNA contained in such HBV Licensed Product, which siRNA is Directed to the Collaboration Target, and pharmaceutical compositions thereof; (ii) such HBV Licensed Product or specific components thereof to the extent such components are unique to such HBV Licensed Product; (iii) methods of using the compositions described in clause (i) or (ii) above in the Field, or to be Directed to the Collaboration Target of such HBV Licensed Product, or to inhibit expression of such Collaboration Target, and foreign equivalents of such method claims; (iv) methods and compositions directed to the synthesis or analysis of the compositions described in clause (i) or (ii); or (b) Alnylam Collaboration IP that is applicable solely to such HBV Licensed Product; provided, however, that any such Patent Rights that include claims that are directed to subject matter applicable to siRNA or siRNA delivery in general will not be considered Alnylam Product-Specific Patent Rights but will be considered Alnylam Core Technology Patent Rights. Alnylam Product-Specific Patent Rights excludes Joint Collaboration IP, includes the Patent Rights set forth on Schedule C-2 (as of the Restatement Effective Date) and may include Patent Rights that constitute Alnylam Collaboration IP.
1.19Alnylam Product-Specific Collaboration IP” shall mean Alnylam Collaboration IP that relates to an HBV Licensed Product or the Collaboration Target and does not (a) have general applicability to RNAi Products, (b) relate to RNAi Products other than an HBV Licensed Product, or (c) relate to targets other than the Collaboration Target; excluding in each case any Alnylam Collaboration IP to the extent such Alnylam Collaboration IP specifically relates to or discloses any HBV Licensed Product or the Collaboration Target.
1.20Applicable Accounting Standards” shall mean then current United States generally accepted accounting principles, consistently applied.
1.21Approved Product” shall have the meaning set forth in Section 4.3.
1.22Back-Up Product” shall have the meaning set forth in Section 4.3.
1.23Bankrupt Party” shall have the meaning set forth in Section 3.4.
1.24Business Day” shall mean a day on which banking institutions in both Boston, Massachusetts and San Francisco, California are open for business.
1.25Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 of each Calendar Year; provided, that (a) the first Calendar Quarter of the Term shall begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of the Term shall end on the last day of the Term, and (b) the first Calendar Quarter of a Royalty Term for a HBV Licensed Product in a country shall begin on the First Commercial Sale of such HBV Licensed Product in such country and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of a Royalty Term shall end on the last day of such Royalty Term.
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1.26Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of the Term, and (b) the first Calendar Year of a Royalty Term for a HBV Licensed Product in a country shall begin on the First Commercial Sale of such HBV Licensed Product in such country and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of such Royalty Term.
1.27Challenge” shall have the meaning set forth in Section 8.2(d).
1.28Challenging Party” shall have the meaning set forth in Section 8.2(d).
1.29Change of Control” shall mean with respect to a Person, any of the following: (a) the sale or disposition of all or substantially all of the assets of such Person or its direct or indirect controlling Affiliate to a Third Party, other than to an entity of which more than fifty percent (50%) of the voting capital stock are owned after such sale or disposition by shareholders of such Person or its direct or indirect controlling Affiliate (in either case, whether directly or indirectly through any parent entity); or (b)(i) the acquisition by a Third Party, alone or together with any of its Affiliates, other than an employee benefit plan (or related trust) sponsored or maintained by such Person or any of its Affiliates, of more than fifty percent (50%) of the outstanding shares of voting capital stock of such Person or its direct or indirect controlling Affiliate, or (ii) the acquisition, merger or consolidation of such Person or its direct or indirect controlling Affiliate with or into another Person, other than, in the case of this clause (b), an acquisition or a merger or consolidation of such Person or its controlling Affiliate in which the holders of shares of voting capital stock of such Person or its controlling Affiliate, as the case may be, immediately prior to such acquisition, merger or consolidation will beneficially own, directly or indirectly, at least fifty percent (50%) of the shares of voting capital stock of the acquiring Third Party or the surviving corporation in such acquisition, merger or consolidation, as the case may be, immediately after such acquisition, merger or consolidation.
1.30Clinical Study” shall mean any clinical study of an HBV Licensed Product in humans.
1.31Collaboration” shall mean the collaboration between the Parties regarding the Development of potential RNAi Products Directed to the Collaboration Target during the Term of this Agreement prior to the Restatement Effective Date.
1.32Collaboration IP” shall mean the collective reference to the Alnylam Collaboration IP, the Vir Bio Collaboration IP and the Joint Collaboration IP.
1.33Collaboration Target” shall mean HBV.
1.34Combination Product” shall mean an HBV Licensed Product and any other clinically active therapeutic or prophylactic ingredient, mechanism or device.
1.35Commercialization” or “Commercialize” shall mean, with respect to a product, activities directed to marketing, promoting, detailing, distributing, importing, having imported, exporting, having exported, selling or offering to sell, or seeking to obtain reimbursement for, such product, whether before or after Regulatory Approval for such product has been obtained.
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1.36Commercially Reasonable Efforts” shall mean (a) with respect to the obligations of a Party under this Agreement that relate to the Development, Manufacture or Commercialization of an HBV Licensed Product, the carrying out of such obligations in [***], taking into account the following factors to the extent reasonable and relevant: [***] in the marketplace, the patent or other proprietary position of such HBV Licensed Product, the regulatory structure involved and the potential profitability of such HBV Licensed Product marketed [***]; and (b) with respect to other obligations under this Agreement, the carrying out of such obligations in a diligent, expeditious and sustained manner using efforts and resources, including reasonably necessary personnel and financial resources, that biopharmaceutical companies of comparable size and resources typically devote to similar obligations.
1.37Commitment Letter Date” shall mean July 28, 2017.
1.38Competing Program” shall have the meaning set forth in Section 7.5(a).
1.39Competitive Infringement” shall have the meaning set forth in Section 5.7(a).
1.40Completion” shall mean, with respect to each Clinical Study, database lock for such Clinical Study.
1.41Compulsory License” shall mean, with respect to an HBV Licensed Product in a country, a compulsory sublicense under the Alnylam Intellectual Property obtained by a Third Party (the “Compulsory Licensee”) through the order, decree, or grant of a Governmental Authority in such country, authorizing such Compulsory Licensee to Develop, Manufacture, or Commercialize such HBV Licensed Product in the Field in such country. A Compulsory Licensee shall not be deemed to be a Sublicensee.
1.42Compulsory License Compensation” shall mean, for a given HBV Licensed Product and a given country in the Territory, the compensation received from a Compulsory Licensee by Vir Bio or any of its Related Parties under a Compulsory License.
1.43Compulsory License Royalty Rate” has the meaning set forth in Section 4.5(e)(ii).
1.44Confidential Disclosure Agreement” shall mean that certain Confidential Disclosure Agreement by and between the Parties effective as of February 23, 2017.
1.45Confidential Information” of a Party shall mean the terms of this Agreement and all Know-How and other information that is of a confidential and proprietary nature to such Party (including Know-How and information of Third Parties) and that is disclosed to the other Party under this Agreement. Confidential Information includes Know-How or other information (whether or not patentable) regarding a Party’s technology, products, business information or objectives and reports and audits under Sections 4.9 and 4.10, and all proprietary biological materials (and data and information associated therewith) of a Party. Alnylam Intellectual Property (other than Joint Collaboration IP) is Confidential Information of Alnylam, except that Alnylam Product-Specific Collaboration IP is the Confidential Information of both Parties. Vir Bio Intellectual Property (other than Joint Collaboration IP) is Confidential Information of Vir Bio. Joint Collaboration IP is the Confidential Information of both Parties, with each Party being considered both the Disclosing Party and the Receiving Party. Confidential Information shall include: (a) the terms and conditions of this Agreement, which shall be the Confidential Information of both Parties; and (b) Confidential Information disclosed by either Party pursuant to the Confidential Disclosure Agreement.
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1.46Control” or “Controlled” shall mean, with respect to any Know-How, Patent Right or other intellectual property right and a Party, the ability of such Party or its Affiliates (whether by ownership or license, other than pursuant to a license granted under this Agreement) to assign, transfer, or grant access to, or a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party; provided, that, with respect to rights to any Third Party Know-How, Patent Rights or other intellectual property right that are licensed to, or otherwise obtained by, Alnylam or its Affiliates pursuant to an agreement entered into by Alnylam or any of its Affiliates after the Effective Date, such Third Party Know-How, Patent Rights or other intellectual property right shall be deemed not to be under the Control of such Party or its Affiliates, or Alnylam or its Affiliates, respectively, unless and until the agreement pursuant to which such rights are obtained becomes an Alnylam In-License pursuant to Section 3.6(b) or (c), as the case may be.
1.47Cover”, “Covered” or “Covering” shall mean, as to a product and Patent Rights, that, in the absence of a license granted under, or ownership of, such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights or, as to a pending claim included in such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights if such pending claim were to issue in an issued patent.
1.48Debar”, “Debarred” or “Debarment” shall mean (a) being debarred, or being subject to a pending debarment, pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, (b) being listed by any federal and/or state agencies, excluded, debarred, suspended or otherwise made ineligible to participate in federal or state healthcare programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. § 1320a-7b(f), or being subject to any pending process by which any such listing, exclusion, debarment, suspension or other ineligibility could occur, (c) being disqualified by any government or regulatory agency from performing specific services, or being subject to a pending disqualification proceeding, or (d) being convicted of a criminal offense related to the provision of healthcare items or services or being subject to any pending criminal action related to the provision of healthcare items or services.
1.49Develop” or “Development” shall mean, with respect to a product, discovery, research, preclinical development, clinical development, and regulatory activities with respect to such product, including test method development and stability testing, design, compatibility testing, toxicology, animal efficacy studies, formulation, quality assurance/quality control development, statistical analysis, clinical studies (including Clinical Studies), regulatory affairs, product approval and registration, chemical development and Manufacturing development, packaging development and Manufacturing and development documentation efforts in support of development activities anywhere in the world, whether before or after Regulatory Approval for such product has been obtained.
1.50Directed to” shall mean, with respect to an siRNA and a Target, that such siRNA [***] of the messenger RNA of such Target, and with respect to a product and a Target, that such product contains an siRNA that [***] of the messenger RNA of such Target.
1.51Disclosing Party” shall have the meaning set forth in Section 6.1(a).
1.52Divest”, “Divesting” and “Divestiture” shall have the meaning set forth in Section 7.5(a).
1.53Dollars” and “$” shall mean United States dollars.
1.54Effective Date” shall mean October 16, 2017.
1.55EMA” shall mean the European Medicines Agency and any successor Governmental Authority having substantially the same function.
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1.56Executive Officer” shall mean, with respect to Vir Bio, Vir Bio’s Chief Executive Officer (or his or her designee), and, with respect to Alnylam, Alnylam’s Chief Executive Officer (or his or her designee).
1.57Existing Alnylam In-Licenses” shall mean the Third Party agreements identified as such in Section 1 of Schedule A.
1.58Existing Alnylam Third Party Agreements” shall mean the Third Party agreements identified as such in Section 3 of Schedule A of the Original Agreement.
1.59Failed Product” shall have the meaning set forth in Section 4.3.
1.60FDA” shall mean the United States Food and Drug Administration or any successor Governmental Authority having substantially the same function.
1.61Field” shall mean all uses and purposes, including the treatment, palliation, diagnosis or prevention of any human disease, disorder or condition, but excluding applications in agriculture, horticulture, forestry, aquaculture, and/or residential markets relating to plants, fish, arthropods and/or pests and pathogens thereof (e.g., home, lawn and/or garden).
1.62First Commercial Sale” shall mean the first commercial sale of an HBV Licensed Product by Vir Bio or its Related Parties in a country following Regulatory Approval of such HBV Licensed Product in that country or, if no such Regulatory Approval or similar marketing approval is required, the date upon which such HBV Licensed Product is first commercially sold in such country to end users. Sales for compassionate use, test marketing or clinical trial purposes shall not constitute a First Commercial Sale.
1.63Follow-On Product” shall have the meaning set forth in Section 4.3.
1.64FTE” shall mean the number of full-time-equivalent person-years (each consisting of a total of [***] hours) of scientific, technical, regulatory, marketing or managerial work by each Party’s personnel on or directly related to the applicable activity conducted hereunder.
1.65Generic Product” shall mean, with respect to an HBV Licensed Product in a country in the Territory, any product sold by a Third Party approved in such country by way of an abbreviated regulatory mechanism by the Regulatory Authority in such country that, in each case, meets the equivalency determination by the applicable Regulatory Authority (including a determination that the product is “comparable”, “interchangeable”, “bioequivalent”, “biosimilar” or other term of similar meaning, with respect to such HBV Licensed Product). A product shall not be considered to be a Generic Product if (a) Vir Bio or any of its Related Parties was involved in or authorized the Development or Commercialization of such product, (b) Vir Bio or any of its Related Parties has granted a license to such Third Party in respect of such product, or (c) such product is Commercialized by any Person who obtained such product in a chain of distribution that included Vir Bio or any of its Related Parties.
1.66Global Access Program” shall mean a program intended to make therapeutic, prophylactic, or diagnostic products available to a developing geographic area or neglected patient population outside of the Major Markets and China, at a reasonable cost for such area or population.
1.67Governmental Authority” shall mean any applicable government authority, court, tribunal, arbitrator, agency, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any state, province, county, city or other political subdivision thereof or (c) any supranational body.
1.68HBV” shall mean human hepatitis B virus.
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1.69HBV Licensed Product” shall mean each of (i) ALN-HBV and (ii) ALN- HBV02, and (iii) any other RNAi Product Directed to HBV that was Controlled by Alnylam (x) on the Effective Date or, subject to Section 7.5(a)(ii), during the Term, and/or (y) was Developed in the HBV Program, in each case, in all dosage forms, formulations and modes/methods of administration, alone or as Combination Products. For clarity, the inclusion of Combination Products in HBV Licensed Products shall not be read to provide a license under this Agreement for any Unlicensed Component under independent intellectual property of Alnylam or its Affiliates covering such Unlicensed Component on a stand-alone basis apart from its inclusion in a Combination Product.
1.70HBV Program” shall mean the Collaboration activities for the Collaboration Target.
1.71ICC Rules” shall have the meaning set forth in Section 10.2(a).
1.72IND” shall mean an application submitted to a Regulatory Authority to initiate human clinical trials, including (a) an Investigational New Drug application or any successor application or procedure filed with the FDA, (b) any equivalent of a U.S. Investigational New Drug application in any country outside the United States, and (c) all supplements and amendments that may be filed with respect to the foregoing.
1.73Initiation” shall mean the first dosing of a human subject participating in a Clinical Study.
1.74Joint Collaboration IP” shall mean collectively, (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, jointly by individuals who are employee(s), agent(s) or consultant(s) of Alnylam or its Affiliates, on the one hand, and individuals who are employee(s), agent(s) or consultant(s) of Vir Bio or its Affiliates, on the other hand, in the conduct of the Collaboration or otherwise under this Agreement, and (b) any Patent Rights that claim such improvements, discoveries or Know-How during the Term.
1.75Know-How” shall mean any biological materials and other tangible materials or intangible information, including data, inventions, practices, methods, protocols, formulas, knowledge, know-how, trade secrets, processes, assays, skills, experience, techniques, governmental or regulatory correspondence (including conversation logs), and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical data and analytical and quality control data, patentable or otherwise.
1.76Knowledge” of a Party shall mean (a) the actual knowledge of any “executive officer” (as defined in Rule 3b-7 promulgated under the Securities Exchange Act of 1934) of such Party or (b) with respect to Alnylam, Alnylam’s Vice President, Intellectual Property and any other Alnylam employee with direct operational responsibility for filing and maintaining the Alnylam Patent Rights who is a Senior Director or above.
1.77Law” shall mean any applicable law, statute, rule, regulation, ordinance or other pronouncement having the effect of law of any Governmental Authority.
1.78Licensor Party” shall have the meaning set forth in Section 8.2(d).
1.79Losses” shall have the meaning set forth in Section 9.1(a).
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1.80Major Market” shall mean each of the [***].
1.81Manufacture” or “Manufacturing” shall mean, with respect to a product and as applicable, all activities associated with the production, manufacture, supply, processing, filling, packaging, labeling, shipping, and storage of such product and/or any components thereof, including process and formulation development, process validation, stability testing, manufacturing scale-up, preclinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.
1.82Manufacturing Costs” shall mean, with respect to the manufacture of HBV Licensed Product by a Party or its Affiliate, to the extent (a) such Party or its Affiliates Manufactures such HBV Licensed Product, the reasonable internal and external costs incurred by such Party and its Affiliates in Manufacturing such HBV Licensed Product, including the fully allocated cost of Manufacture of such HBV Licensed Product, consisting of direct material and direct labor costs (including direct material and labor costs incurred for HBV Licensed Product manufacturing process start-up and validation), plus overhead directly attributable to the Manufacture of such HBV Licensed Product (including all directly incurred Manufacturing variances and a reasonable allocation of Manufacturing administrative and facilities operations and facilities depreciation costs for such HBV Licensed Product, but in all cases excluding corporate administrative overhead), all calculated strictly in accordance with Applicable Accounting Standards, and (b) such HBV Licensed Product is Manufactured by a Third Party manufacturer, the actual fees paid by such Party to the Third Party for the Manufacture and supply of such HBV Licensed Product, including any prepayments, reservation, and cancellation fees, costs of failed batches and any value-added tax or similar tax due for amounts paid to such Third Party directly attributable to such HBV Licensed Product; provided that any such Manufacturing Costs [***]. Any Development or Manufacturing costs that can be classified under costs of goods pursuant to Applicable Accounting Standards will be classified as such for the purposes of calculating Manufacturing Costs, and such calculation shall be made in accordance with Applicable Accounting Standards.
1.83MicroRNA” or “miRNA” shall mean a structurally defined functional RNA molecule usually between [***] nucleotides in length, which is derived from an endogenous, genetically-encoded non-coding RNA which is predicted to be processed into a hairpin RNA structure that is a substrate for the double-stranded RNA-specific ribonuclease Drosha and subsequently is predicted to serve as a substrate for the enzyme Dicer, a member of the RNase III enzyme family.
1.84MicroRNA Mimic” shall mean a single-stranded or double-stranded oligonucleotide with the same or substantially similar-base composition and sequence (including chemically modified bases) as a particular natural miRNA and which is designed to mimic the activity of such miRNA. For clarity, MicroRNA Mimic excludes a double-stranded oligonucleotide which functions or is designed to function as an siRNA.
1.85Milestone Payment” shall have the meaning set forth in Section 4.3.
1.86NDA” shall mean a New Drug Application, Biologics License Application, Marketing Authorization Application or similar application or submission filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological, pharmaceutical or other therapeutic or prophylactic product in that country or in that group of countries, and all supplements and amendments that may be filed with respect to the foregoing.
1.87Net Sales” shall mean for any period and for any country in the Territory, the total aggregate amount billed during such period in such country by Vir Bio or its Related Parties in such country for all sales of the HBV Licensed Products to Third Parties (other than to a Sublicensee of Vir Bio or its Affiliates) after deducting, if not previously deducted, from the amount invoiced or received, the following deductions to the extent actually applied or taken with respect to such sales of HBV Licensed Products: [***]. Such amounts shall be determined from the books and records of Vir Bio and its Related Parties, maintained in accordance with Applicable Accounting Standards, consistently applied.
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If any HBV Licensed Product is sold as a Combination Product, the Net Sales from the Combination Product, for the purposes of determining milestones and royalties, shall be determined by multiplying the Net Sales of the Combination Product during the applicable Calendar Quarter, by the fraction, A/(A+B), where A is the average sale price of a Sole Compound Product (as defined below) when sold separately in finished form and B is the average sale price of the other active compounds or active ingredients included in the Combination Product when sold separately in finished form, in each case during the applicable Calendar Quarter or, if sales of both the Sole Compound Product and the other active compounds or active ingredients did not occur in such period, then in the most recent Calendar Quarter in which sales of both occurred. If such average sale price cannot be determined for both the Sole Compound Product and all other active compounds or active ingredients included in the Combination Product, Net Sales for the purposes of determining milestones and royalties shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of C/(C+D) where C is the fair market value of the Sole Compound Product and D is the fair market value of all other active compounds or active ingredients included in the Combination Product. In such event, Vir Bio shall in good faith make a determination of the respective fair market values of the Sole Compound Product and all other active compounds or active ingredients included in the Combination Product, and shall notify Alnylam of such determination and provide Alnylam with Vir Bio’s basis for such determination. If Alnylam in good faith does not agree with such determination, Alnylam shall give Vir Bio written notice of its disagreement within [***] after receiving the relevant report pursuant to Section 4.9, and the matter shall be submitted for final and binding resolution pursuant to the baseball arbitration provisions in Section 10.3. “Sole Compound Product” shall mean a product containing no active compounds or active ingredients other than an siRNA.
In the case of any sale or other disposal for value, such as barter or counter-trade, of HBV Licensed Product, or part thereof, other than in an arm’s length transaction exclusively for cash, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the HBV Licensed Product in the country of sale or disposal, as determined in accordance with Applicable Accounting Standards.
Sales between or among Vir Bio and its Related Parties shall be excluded from the computation of Net Sales, but Net Sales shall include sales to the first Third Party (other than a Sublicensee of Vir Bio or its Affiliate) thereafter by Vir Bio or its Related Parties.
1.88Neutral Expert” shall have the meaning set forth in Section 10.3(a).
1.89Non-Acquired Party” shall have the meaning set forth in Section 3.7.
1.90Non-Bankrupt Party” shall have the meaning set forth in Section 3.4.
1.91Notice Date” shall have the meaning set forth in Section 10.3(a).
1.92Original Agreement” shall have the meaning set forth in the Preamble.
1.93Party” shall mean Alnylam or Vir Bio and “Parties” shall mean Alnylam and Vir Bio collectively.
1.94Patent Rights” shall mean patents, patent applications and/or provisional patent applications, utility models and utility model applications, design patents or registered industrial designs and design applications or applications for registration of industrial designs, and all substitutions, divisionals, continuations, continuation-in-part applications, continued prosecution applications, requests for continued examinations, reissues, reexaminations and extensions thereof, in any country of the world. For clarity, any Patent Rights shall include any future Patent Rights that claim priority to or common priority with such Patent Rights.
1.95Person” shall mean any corporation, limited or general partnership, limited liability company, joint venture, trust, unincorporated association, governmental body, authority, bureau or agency, any other entity or body, or an individual.
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1.96Pharmacovigilance Agreement” shall mean that certain Clinical Safety Data Exchange Agreement between Vir Bio and Alnylam dated as of August 30, 2024, as amended by time to time.
1.97Phase I Study” shall mean a study of an HBV Licensed Product in human volunteers or patients the purpose of which is preliminary determination of safety and tolerability of a dosing regime and for which there are no primary endpoints (as recognized by the FDA or other Regulatory Authorities) in the protocol relating to efficacy.
1.98Phase II Study” shall mean a study of an HBV Licensed Product to evaluate preliminary efficacy and establish safety, appropriate dosage and pharmacological activity in the target patient population.
1.99Phase III Study” shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain Regulatory Approval to market such product in patients having the disease or condition being studied as described in U.S. 21 C.F.R. § 312.21(c), or a similar clinical study in a country other than the United States.
1.100Pivotal Study” shall mean a Phase III Study and any other Clinical Study in humans prospectively designed as a pivotal study to demonstrate whether the product is safe and effective for use in the indication under investigation in a manner sufficient to file a drug approval application for such indication in a Major Market, whether or not such trial is called a “Phase III” Study. Without limiting the generality of the foregoing, a clinical study will be deemed to be a Pivotal Study if such study has been designated by the sponsor as a Phase III clinical trial on www.clinicaltrials.gov (or any successor website maintained by the U.S. National Institutes of Health or any successor agency of the U.S. government) or any analogous website in a Major Market.
1.101POC Study” shall mean a Clinical Study of an HBV Licensed Product that is designed to demonstrate human safety and [***].
1.102Pre-Existing Affiliates” shall have the meaning set forth in Section 3.7.
1.103Product Trademark(s)” shall mean the trademark(s) and service mark(s) for use in connection with the distribution, marketing, promotion and sale of HBV Licensed Products, and/or accompanying logos, trade dress and/or indicia of origin. Product Trademarks specifically excludes the corporate names and logos of the Parties and their Related Parties.
1.104Program Transaction” shall mean (a) a sublicense by Vir Bio or its Affiliate of any rights to any Alnylam Intellectual Property (or sale of a covenant not to sue), (b) a license by Vir Bio or its Affiliate of any rights to any Vir Bio Collaboration IP (or sale of a covenant not to sue) to the extent in connection with an HBV Licensed Product, (c) an assignment by Vir Bio or its Affiliate (other than in connection with a Change of Control of Vir Bio) of any rights to any Alnylam Intellectual Property, (d) the grant by Vir Bio or its Affiliates of an option to acquire any of the foregoing, in each case with respect to an HBV Licensed Product. Notwithstanding the foregoing, Program Transactions exclude agreements with Third Parties for any Change of Control of Vir Bio, distributors of HBV Licensed Product in the ordinary course of trade, contract manufacturing organizations (CMOs), contract research organizations (CROs), academic research organizations (AROs) and other contractors, or academic, non-profit or governmental entities, in each case where (i) the agreement counterparty is performing services for or collaborating with Vir Bio or its Affiliates and the counterparty and its Affiliates are not granted any Commercialization rights of any kind with respect to any Alnylam Intellectual Property or HBV Licensed Product(s) (including options for commercial rights and whether pursuant to the same or under a different agreement) and (ii) no revenue will be received by Vir Bio or any of its Affiliates.
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1.105Program Transaction Revenue” shall mean all consideration actually received by Vir Bio or its Affiliate from any Person from or pursuant to a Program Transaction, excluding only: (a) [***]; (b) research and development reimbursement for research and development prior to or to be performed after the date of the Program Transaction, accounted for at reasonable and customary rates, on a full time equivalent basis (any excess over a reasonable and customary FTE rate is included in Program Transaction Revenue) or in the form of external costs billed through on a pass-through basis [***]; (c) reimbursement of patent or other intellectual property expenses on a pass-through basis [***]; (d) payments for equity of Vir Bio to the extent at fair market value (the amount of any premium is included in Program Transaction Revenue); (e) proceeds of repayable loans that are not forgiven (if later forgiven, the amount of the forgiven debt is included in Program Transaction Revenue); (f) payments for supply of HBV Licensed Product to the extent of Vir Bio’s (or its Affiliate’s) fully burdened manufacturing cost [***]; and (g) research and development funding from governmental or non-profit entities to the extent required to be spent on research and development occurring after the date the Program Transaction is signed. (h) If Vir Bio or its Affiliate receives consideration from any Person from or pursuant to a Program Transaction in respect of HBV Licensed Product(s) on the one hand, and rights to exploit any other compound(s) or product(s) on the other hand, then (i) such consideration shall be reasonably allocated by Vir Bio between, as applicable, the HBV Licensed Product(s) and such other compound(s) or product(s), and the portion allocated to HBV Licensed Product(s) will be the Program Transaction Revenue for such Program Transaction, and (ii) Vir Bio shall promptly notify Alnylam of, and provide Alnylam with a copy of all relevant Program Transaction agreements, along with an explanation of any allocation with respect to the consideration under such agreements in accordance with the immediately preceding sentence. If Alnylam does not agree with Vir Bio’s allocation of such consideration, Alnylam shall provide written notice of such disagreement (“Allocation Dispute Notice”) within [***] after receipt of such allocation and Vir Bio and Alnylam will negotiate and endeavor to agree in good faith on an allocation within [***] after the receipt of the Allocation Dispute Notice. If the Parties agree within such [***] period, the Parties will use such agreed-upon allocation to determine the Program Transaction Revenue. If despite such good faith efforts, the Parties are unable to agree upon such allocation within such [***] period, then the matter shall be submitted for final and binding resolution pursuant to the baseball arbitration provisions in Section 10.3.
1.106Receiving Party” shall have the meaning set forth in Section 6.1(a).
1.107Regulatory Approval” shall mean the approval of the applicable Regulatory Authority necessary for the marketing and sale of an HBV Licensed Product for a particular indication in a country, including separate pricing and/or reimbursement approvals that may be required.
1.108Regulatory Authority” shall mean the federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, manufacture, use, storage, import, promotion, marketing or sale of an HBV Licensed Product in a country or territory.
1.109Related Party” shall mean, with respect to a Party, such Party’s Affiliates and permitted Sublicensees.
1.110Representative Expert” shall have the meaning set forth in Section 10.3(b).
1.111Restatement Effective Date” shall have the meaning set forth in the Preamble.
1.112RNAi Product” shall mean any product that contains or is comprised of one or more siRNAs as an active ingredient.
1.113Royalty Patent” shall have the meaning set forth in Section 4.5(c).
1.114Royalty Term” shall have the meaning set forth in Section 4.5(c).
1.115Sales Milestone” shall have the meaning set forth in Section 4.4.
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1.116siRNA” shall mean an oligonucleotide composition of native or chemically modified RNA that targets a gene through activation of the RNA interference pathway, and that is not a MicroRNA, MicroRNA antagonist or MicroRNA Mimic.
1.117Stock Purchase Agreement” shall mean that certain Common Stock Issuance Agreement between the Parties dated as of the Effective Date, as such agreement is amended from time to time.
1.118Sublicensee” shall mean, with respect to Vir Bio or Alnylam, as the case may be, a Third Party to whom such Party grants a sublicense under any Alnylam Intellectual Property or Vir Bio Intellectual Property, respectively (or a license, in the case of Joint Collaboration IP) to Develop, Manufacture or Commercialize an HBV Licensed Product in the Field pursuant to Section 3.1 or Section 3.2, as applicable.
1.119Target” shall mean (a) a polypeptide that is a site or potential site of therapeutic intervention by a therapeutic agent, or a nucleic acid which is required for expression of such polypeptide; (b) variants of a polypeptide (including any splice variant thereof), cellular entity or nucleic acid described in the foregoing clause (a); or (c) a defined non-peptide entity, including a microorganism, virus, bacterium, fungus, or single-cell parasite; provided, that the entire genome of a virus shall be regarded as a single Target.
1.120Term” shall have the meaning set forth in Section 8.1.
1.121Terminated Product” shall have the meaning set forth in Section 8.3.
1.122Territory” shall mean all countries of the world.
1.123Third Party” shall mean any Person other than Alnylam or Vir Bio and their respective Affiliates.
1.124Third Party License Payment” shall mean royalties, upfront fees, milestones or other amounts payable under an Alnylam In-License.
1.125Transaction Agreements” shall mean, collectively, this Agreement and the Pharmacovigilance Agreement.
1.126United States” or “U.S.” shall mean the United States of America and its territories and possessions.
1.127Unlicensed Component” shall mean any clinically active therapeutic or prophylactic ingredient, mechanism or device component of a Combination Product that is not an HBV Licensed Product.
1.128Valid Claim” shall mean a claim of: (a) an issued and unexpired Patent Right, which claim has not been (i) 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, or (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise, or (b) a patent application that has been pending less than [***], which claim has not been cancelled, withdrawn or abandoned, or finally rejected by an administrative agency action from which no appeal can be taken.
1.129VAT” shall have the meaning set forth in Section 4.14.
1.130Vir Bio” shall have the meaning set forth in the Preamble.
1.131Vir Bio-Alnylam Letter Agreement” shall mean that certain letter agreement between Alnylam and Vir Bio dated November 13, 2018 with respect to the Brii Bio License.
1.132Vir Bio-Brii Bio Agreement” shall mean [***].
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1.133Vir Bio Collaboration IP” shall mean (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Vir Bio or its Affiliates and Controlled by Vir Bio at any time during the Term, in each case in the conduct of the Collaboration or otherwise under this Agreement, and (b) any Patent Rights which claim such improvements, discoveries or Know-How. Vir Bio Collaboration IP excludes Vir Bio’s interest in Joint Collaboration IP.
1.134Vir Bio Improvements” means any patented improvement, discovery or Know-How that (a) is first conceived or reduced to practice, or with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Vir Bio or its Affiliates in the course of conducting Development, Manufacturing or Commercialization activities with respect to HBV Licensed Products under this Agreement, (b) is Controlled by Vir Bio or its Affiliates, and (c) constitutes an improvement that would otherwise be dominated by Alnylam Core Technology Patent Rights, including, as applicable, formulation technology.
1.135Vir Bio Indemnitees” shall have the meaning set forth in Section 9.1(b).
1.136Vir Bio Intellectual Property” shall mean collectively, Vir Bio Know-How, Vir Bio Patent Rights, Vir Bio Collaboration IP and Vir Bio’s interest in Joint Collaboration IP.
1.137Vir Bio Know-How” shall mean Know-How Controlled by Vir Bio at any time during the Term that is reasonably necessary or useful to Develop, Manufacture or Commercialize HBV Licensed Products, other than Alnylam Know-How and Patent Rights comprising Vir Bio Collaboration IP or Joint Collaboration IP.
1.138Vir Bio Patent Rights” shall mean Patent Rights Controlled by Vir Bio at any time during the Term that are reasonably necessary or useful to Develop, Manufacture or Commercialize HBV Licensed Products, other than Alnylam Patent Rights and Patent Rights comprising Vir Bio Collaboration IP or Joint Collaboration IP.
1.139Withholding Amount” has the meaning set forth in Section 4.13.
2HBV LICENSED PRODUCT DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION.
2.1HBV Program. Prior to the Restatement Effective Date, the Parties engaged in the Development of ALN-HBV and ALN-HBV02, each an RNAi Product Directed to HBV and Vir Bio assumed all responsibility for the Development of HBV Licensed Products. After the Restatement Effective Date, at Vir Bio’s sole expense, Vir Bio shall be responsible for the further Development, Manufacture and Commercialization of HBV Licensed Products. For clarity, Alnylam did not and is not exercising the Profit- Sharing Option (as defined in the Original Agreement) for the HBV Licensed Product and the Profit-Sharing Option (as defined in the Original Agreement) for the HBV Licensed Product is hereby terminated.
2.2Diligence. Vir Bio shall use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval and following Regulatory Approval, Commercialize [***] HBV Licensed Product in the Field in [***] Major Markets.
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2.3Reports. Vir Bio shall prepare and deliver to Alnylam, by no later than each February 28 (for the period ending December 31 of the prior Calendar Year), written reports summarizing Development and Commercialization activities for all HBV Licensed Products performed to date (or updating such report for activities performed since the last such report submitted hereunder, as applicable). In addition, with respect to each such HBV Licensed Product, Vir Bio shall provide Alnylam with written notice of the achievement of each applicable milestone event in Section 4.3 or 4.4, the First Commercial Sale in the Territory, and receipt of any Program Transaction Revenue within [***] after such event; provided, however, that to the extent reasonably practicable and except as required by Law, Vir Bio shall inform Alnylam of such event prior to public disclosure of such event by Vir Bio. To the extent such information is available, Vir Bio shall also provide such other information to Alnylam as Alnylam may reasonably request from time to time but not more than [***], with respect to Vir Bio’s Development and Commercialization activities for HBV Licensed Products in order for Alnylam to monitor Vir Bio’s compliance with its obligations under this Agreement. [***]
2.4Records. Vir Bio will maintain scientific records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which will fully and properly reflect all work done and results achieved in the performance of the Development activities with respect to each HBV Licensed Product by such Party.
2.5Regulatory Matters. Vir Bio shall be the party responsible for obtaining Regulatory Approval of the HBV Licensed Products. Vir Bio will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it with respect to HBV Licensed Products. Vir Bio will, as to such HBV Licensed Products, (a) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (b) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (c) be responsible for maintaining all regulatory filings. Alnylam shall not communicate with any Regulatory Authority regarding any HBV Licensed Product, without Vir Bio’s prior written consent, except as required by Law or as requested or required by a Regulatory Authority; provided, however, that to the extent reasonably practical Alnylam will consult with Vir Bio in advance of such communication. With respect to each HBV Licensed Product, Vir Bio shall provide Alnylam with written notice of all Regulatory Approvals obtained or denied and the filing of any IND for such HBV Licensed Product within [***] after such event; provided, however, that to the extent reasonably practicable and except as required by Law, Vir Bio shall inform Alnylam of such event prior to public disclosure of such event by Vir Bio. Vir Bio will have the right to reference Alnylam’s INDs and other filings with and submissions to Regulatory Authorities with respect to an HBV Licensed Product to obtain Regulatory Approval in the Territory for such HBV Licensed Product.
2.6Pharmacovigilance. The Parties will follow the safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, and any product quality and product complaints involving adverse experiences, related to HBV Licensed Products in accordance with the Pharmacovigilance Agreement. Alnylam shall notify Vir Bio of any regulatory matters, safety concerns or product quality issues relating generally to RNAi Products of which Alnylam has Knowledge, and that, in Alnylam’s reasonable judgment, may have a material effect on the Development, Regulatory Approval or Commercialization (including patient safety or product quality) of HBV Licensed Products; provided, however, that the foregoing shall not require Alnylam to violate any agreements with or confidentiality obligations owed to any Third Party.
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2.7Third Parties. Vir Bio shall be entitled to utilize the services of Third Party contract research and contract manufacturing organizations to perform its Development and Manufacturing activities under this Agreement; provided, that (a) Vir Bio shall ensure that any such Third Party it utilizes operates in a manner consistent with the terms of this Agreement and (b) Vir Bio shall remain at all times fully liable for its responsibilities under this Agreement. Vir Bio shall ensure that any agreement with any such Third Party shall include confidentiality and non-use provisions that are no less stringent than those set forth in Section 6.1 of this Agreement and shall use Commercially Reasonable Efforts to obtain ownership of, and/or a fully sublicenseable license under and to, any Know- How and Patent Rights that are developed or used by such Third Party in the performance of such agreement and are reasonably necessary or useful to Develop, Manufacture and/or Commercialize the applicable HBV Licensed Products in the Field.
2.8Collaborations. The Parties agree that it may be necessary or useful for Vir Bio to enter into Third Party collaborations that provide intellectual property that is necessary or useful for the Development or Commercialization of HBV Licensed Products under this Agreement, including Combination Products. Such Third Party collaborations shall not conflict with the terms and conditions of this Agreement. Vir Bio shall use Commercially Reasonable Efforts to ensure that, to the extent possible, that such Third Party collaboration provides that any and all data and results, discoveries and inventions, whether patentable or not, arising out of the Third Party collaboration may be used by the Parties and their Related Parties and shall include confidentiality and non-use provisions that are no less stringent than those set forth in Article 6 of this Agreement. In addition, Vir Bio shall use Commercially Reasonable Efforts to obtain a right to sublicense to Alnylam and its Related Parties any intellectual property arising out of the Third Party collaboration. For clarity, such Third Party collaboration shall not include agreements with any contract research or contract manufacturing organization entered into in accordance with the provisions set forth in Section 2.8, or with a Sublicensee of the HBV Licensed Product.
3GRANT OF LICENSE RIGHTS.
3.1License Grants to Vir Bio.
(a)Development and Commercialization License. Subject to the terms and conditions of this Agreement, including those set forth in Section 3.1(d), Alnylam hereby grants Vir Bio a non-transferable (except as provided in Section 11.3), sublicenseable (through multiple tiers and subject to Section 3.1(c)), exclusive license under the Alnylam Intellectual Property to Develop, use, sell, have sold, import, and otherwise Commercialize HBV Licensed Products in the Field in the Territory. Such license shall be royalty-bearing for the Royalty Term applicable to each such HBV Licensed Product in each country in the Territory, and, after the expiration of the Royalty Term applicable to such HBV Licensed Product in such country, shall convert to a [***] fully paid-up, irrevocable and perpetual license for such HBV Licensed Product in the Field in such country.
(b)Manufacturing License. Subject to the terms and conditions of this Agreement, including those set forth in 3.1(d), Alnylam hereby grants Vir Bio a non-transferable (except as provided in Section 11.3), sublicenseable (through multiple tiers and subject to Section 3.1(c)), worldwide, royalty-bearing, exclusive license under Alnylam Intellectual Property to Manufacture HBV Licensed Products for Development of HBV Licensed Products and for Commercialization in the Field in the Territory. Such license shall be royalty-bearing for the Royalty Term applicable to each HBV Licensed Product in each country in the Territory, and, after the expiration of the Royalty Term applicable to such HBV Licensed Product in such country, shall convert to a [***] fully paid-up, irrevocable, and perpetual license for such HBV Licensed Product in the Field in such country.
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(c)Sublicensing Terms.
(i)Vir Bio shall have the right to sublicense (through multiple tiers) any of its rights under Sections 3.1(a) and 3.1(b) to any Affiliate of Vir Bio so long as it remains an Affiliate of Vir Bio, and to any Third Party if such Third Party [***]. Any such sublicense shall comply with the applicable terms of this Agreement, including the requirements of this Section 3.1(c) and payment to Alnylam of its share of any Program Transaction Revenue pursuant to Section 4.6.
(ii)Each sublicense granted by Vir Bio pursuant to this Section 3.1(c) shall be subject to the terms and conditions of this Agreement, and shall contain terms and conditions consistent with the relevant terms in this Agreement. Vir Bio shall promptly provide Alnylam with a copy of the fully executed sublicense agreement covering any Development or Commercialization sublicense granted hereunder, provided that Vir Bio shall have the right to redact commercially sensitive terms in such sublicense to the extent that such redacted terms are not necessary for Alnylam to confirm its rights under this Agreement, and each such sublicense agreement shall contain the following provisions: [***].
(iii)Vir Bio shall use Commercially Reasonable Efforts to ensure that, to the extent possible, each such sublicense agreement provides that any and all data and results, discoveries, and inventions, whether patentable or not, arising out of the sublicense and in connection with the HBV Licensed Products may be used by each Party and its Related Parties to perform such Party’s obligations and to exploit such Party’s rights under the relevant Transaction Agreements. In addition, Vir Bio shall [***].
(iv)Notwithstanding any sublicense, Vir Bio shall remain primarily liable to Alnylam for the performance of all of Vir Bio’s obligations under, and Vir Bio’s compliance with all terms and conditions of, this Agreement, including all obligations delegated to its Sublicensees.
(d)Retained Rights. Notwithstanding the license grants in Sections 3.1(a) and 3.1(b), Alnylam retains the rights under Alnylam Intellectual Property, subject to Alnylam’s obligations under Section 7.5(a), for [***].
3.2License Grants to Alnylam.
(a)Vir Bio Improvements License. Subject to the terms and conditions of this Agreement, Vir Bio hereby grants Alnylam a non-transferable (except as provided in Section 11.3), sublicenseable (subject to Section 3.2(c)), worldwide, non-exclusive, royalty-free license under any Vir Bio Improvements solely for research use in connection with [***]. Such license is subject to the exclusive license grants to Vir Bio under Section 3.1 and the terms of [***].
(b)Sublicensing Terms.
(i)Alnylam shall have the right to sublicense any of its rights under Section 3.2(a) or Section 8.3(b) to any of its Affiliates or to any Third Party [***], subject to the requirements of this Section 3.2(c).
(ii)Each sublicense granted by Alnylam pursuant to this Section 3.2(c) shall be subject to the terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement. Alnylam shall promptly provide Vir Bio with a copy of the fully executed sublicense agreement covering any Commercialization sublicense granted hereunder, provided that Alnylam shall have the right to redact commercially sensitive terms in such sublicense to the extent that such redacted terms are not necessary for Vir Bio to confirm its rights under this Agreement, and each such sublicense agreement shall contain a requirement that the Sublicensee comply with confidentiality and non- use provisions that are no less stringent than Section 6.1 with respect to Vir Bio’s Confidential Information.
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(iii)Notwithstanding any sublicense, Alnylam shall remain primarily liable to Vir Bio for the performance of all of Alnylam’s obligations under, and Alnylam’s compliance with all terms and conditions of, this Agreement, including any obligations delegated to its Sublicensees.
3.3Joint Collaboration IP. Subject to the rights and licenses granted to, and the obligations of, each Party under this Agreement, including each Party’s obligations under Section 7.5(a), each Party shall have the right to exploit its interest in Joint Collaboration IP without the consent of and without accounting to the other Party.
3.4Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by a Party to the other, including those set forth in Sections 3.1 and 3.2, are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties and their respective Related Parties, as sublicensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code and any foreign counterpart thereto. The Parties further agree that that upon commencement of a bankruptcy proceeding by or against a Party (the “Bankrupt Party”) under the U.S. Bankruptcy Code, the other Party (the “Non-Bankrupt Party”) will be entitled to a complete duplicate of, or complete access to (as the Non- Bankrupt Party deems appropriate), all such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments of such intellectual property will be promptly delivered to the Non-Bankrupt Party (a) upon any such commencement of a bankruptcy proceeding and upon written request by the Non-Bankrupt Party, unless the Bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the Bankrupt Party and upon written request by the Non-Bankrupt Party. The Bankrupt Party (in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) agrees not to interfere with the exercise by the Non-Bankrupt Party or its Related Parties of its rights and licenses to such intellectual property and such embodiments of intellectual property in accordance with this Agreement, and agrees to assist the Non-Bankrupt Party and its Related Parties in obtaining such intellectual property and such embodiments of intellectual property in the possession or control of Third Parties as reasonably necessary or desirable for the Non-Bankrupt Party to exercise such rights and licenses in accordance with this Agreement. The foregoing provisions are without prejudice to any rights the Non-Bankrupt Party may have arising under the U.S. Bankruptcy Code or other Laws.
3.5No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest or other right in any Know-How, Patent Rights or other intellectual property rights of the other Party, including items owned, controlled or developed by the other Party, or provided by the other Party to the receiving Party at any time pursuant to this Agreement.
3.6Alnylam In-Licenses and Existing Alnylam Third Party Agreements.
(a)Compliance with Alnylam In-Licenses. All licenses and other rights granted to Vir Bio under this Article 3 (including any sublicense rights) are subject to the applicable rights and obligations of Alnylam and its Affiliates under the Existing Alnylam In-Licenses set forth in Schedule A-1, any Alnylam In-Licenses designated as such pursuant to Section 3.6(b) and the Existing Alnylam Third Party Agreements. Vir Bio shall comply with all applicable terms and conditions of the Alnylam In-Licenses and [***]. Without limiting the foregoing, Vir Bio [***].
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(b)Acceptance of Future Alnylam In-Licenses. In the event that Alnylam or its Affiliate enters into an agreement with a Third Party after the Effective Date that meets the criteria set forth in clause (b) of the definition of Alnylam In-License, then Alnylam will promptly provide Vir Bio with notice and a copy of the applicable Third Party agreement. Within [***] following receipt of such notice, Vir Bio will decide, [***]. In the event that Vir Bio declines to accept such agreement as an Alnylam In-License, any rights granted to Vir Bio thereunder will not be deemed to be “Controlled” by Alnylam or licensed to Vir Bio under this Agreement, and will not be subject to the payment provisions under this Agreement relating to In-Licenses. In the event that Vir Bio accepts such Third Party agreement as an Alnylam In-License, such agreement will thereafter be included within the definition of Alnylam In-License and the Parties will update Schedule A-1 accordingly, and any rights granted to Alnylam thereunder will be deemed to be “Controlled” by Alnylam and sublicensed to Vir Bio pursuant to the terms of this Agreement.
(c)Payments Under Alnylam In-Licenses. Vir Bio shall bear and reimburse Alnylam for [***] of any Third Party License Payments under the Alnylam In-Licenses that become payable based on the Development, Manufacturing or Commercialization of any HBV Licensed Product.
3.7No Reach Through to Acquirer IP. Notwithstanding anything in this Agreement to the contrary, following the closing of a Change of Control of a Party (the “Acquired Party”), the Parties agree that the other Party (the “Non-Acquired Party”) shall not obtain rights or access to the Patent Rights or Know- How controlled by the Acquirer (as defined below) or any of the Affiliates of such Acquirer (other than the Acquired Party and its Affiliates that exist immediately prior to the closing of such Change of Control (such Affiliates, the “Pre-Existing Affiliates”)); and the Acquirer and its Affiliates (other than the Acquired Party and its Pre-Existing Affiliates) shall not obtain rights or access to the Patent Rights or Know-How controlled by the Non-Acquired Party or any of its Affiliates pursuant to this Agreement, or be bound by the restrictions set forth in Section 7.5(a)(i), subject to Section 7.5(a)(ii). For clarity but without limitation, the Non- Acquired Party’s rights in all Patent Rights and Know-How Controlled by the Acquired Party or any of its Pre-Existing Affiliates, which Patent Rights and Know-How exist as of the date of the closing of such Change of Control and are then licensed hereunder to the Non-Acquired Party, shall remain licensed to such Non-Acquired Party after the date of the closing of such Change of Control in accordance with and subject to the terms and conditions of this Agreement and shall not be affected in any manner by virtue of such Change of Control. “Acquirer” shall mean, with respect to the Acquired Party, the Third Party that acquires such Acquired Party or its direct or indirect controlling Affiliate, or that acquires all or substantially all of the assets of the Acquired Party or its direct or indirect controlling Affiliate.
4FINANCIAL PROVISIONS.
4.1Upfront Fee. As partial consideration for the licenses and other rights granted by Alnylam to Vir Bio under this Agreement on the Restatement Effective Date, within [***] after the Restatement Effective Date, Vir Bio shall pay Alnylam a total of Thirty Million Dollars ($30,000,000) [***].
4.2License Grant Equity Consideration. Prior to the Restatement Effective Date, in partial consideration for the licenses and other rights granted by Alnylam to Vir Bio under this Agreement, Vir Bio issued to Alnylam, or caused to be issued to Alnylam, 10,000,000 shares of fully paid, non-assessable common stock, par value $0.0001 per share, of Vir Bio in accordance with the Stock Purchase Agreement.
4.3Development and Regulatory Milestone Fees. As partial consideration for the licenses and other rights granted by Alnylam to Vir Bio in this Agreement, Vir Bio shall make the non-refundable, non- creditable milestone payments (“Milestone Payment”) to Alnylam set forth below no later [***] after the earliest date on which Vir Bio becomes aware that the corresponding milestone event has first been achieved with respect to an HBV Licensed Product. [***]
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Milestone Payments Payable Only Once; Follow-On Product. Each Milestone Payment with respect to an HBV Licensed Product under Section 4.3 shall be payable only once, irrespective of dosage, formulation forms, route of administration or indications for a particular HBV Licensed Product. For purposes of clarity, [***]. However, once Regulatory Approval of an NDA for a HBV Licensed Product has occurred (“Approved Product”) and Development of an HBV Licensed Product that is not solely a variation of dosage, formulation form, or route of administration of such Approved Product, or for a new indication for such Approved Product (“Follow-On Product”), commences or continues, then (i) Milestone Payments shall be due and payable with respect to the Development and Regulatory Approval of the Follow-On Product, and [***].
4.4Sales Milestone Fees. As partial consideration for the licenses and other rights granted by Alnylam to Vir Bio in this Agreement, Vir Bio shall make the non-refundable, non-creditable milestone payments to Alnylam set forth below no later than [***] after the end of the Calendar Year in which the corresponding milestone event (a “Sales Milestone”) has first been achieved with respect to the HBV Licensed Products: [***]
With respect to the foregoing Sales Milestones, payment shall be made only once for each milestone regardless of the number of times aggregate Calendar Year Net Sales for all HBV Licensed Products in the Territory reach a particular dollar threshold. In no event shall the total milestone payments under this Section 4.4 exceed Two Hundred Fifty Million Dollars ($250,000,000) for HBV Licensed Products. If HBV Licensed Products achieve a higher Sales Milestone in a Calendar Year without having first achieved a lower Sales Milestone in any previous Calendar Year, then the milestone payment(s) for the lower Sales Milestone(s) shall be due and payable to Alnylam concurrently with the milestone payment for the higher Sales Milestone that has been achieved.
4.5Royalties Payable on HBV Licensed Products.
(a)Subject to the terms and conditions of this Agreement, as partial consideration for the licenses and other rights granted by Alnylam to Vir Bio in this Agreement, Vir Bio shall pay to Alnylam royalties on Net Sales by Vir Bio and its Related Parties of HBV Licensed Products calculated using the following royalty rate based on the aggregate Calendar Year Net Sales of all HBV Licensed Products in the Territory: [***]
(b)For the avoidance of doubt, Vir Bio’s obligation to pay royalties under this Section 4.5 is imposed only once with respect to the same unit of HBV Licensed Product, including by reason of such HBV Licensed Product being Covered by more than one Valid Claim of Alnylam Patent Rights.
(c)Royalty Term. The period during which the royalties set forth in this Section 4.5 shall be payable, on a HBV Licensed Product-by-HBV Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of such HBV Licensed Product in such country and continue until the later of (i) the expiration of the last Valid Claim of any Alnylam Patent Right or any Patent Right included in the Collaboration IP (“Royalty Patent”) that Covers [***] the HBV Licensed Product in such country of sale, and (ii) the tenth (10th) anniversary of the First Commercial Sale of the HBV Licensed Product in such country (each such period, a “Royalty Term”).
(d)Royalty Reductions.
(i)Know-How Royalty. If the Royalty Term for a given HBV Licensed Product in a country extends beyond the last to expire Valid Claim of a Royalty Patent in such country, then the royalty rate applicable to such HBV Licensed Product in such country shall be reduced [***] of the rate set forth in Section 4.5(a) above for any remaining portion of the Royalty Term that applies to such HBV Licensed Product in such country.
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(ii)Generic Entry. If one or more Generic Products is sold in a country in the Territory during the Royalty Term for an HBV Licensed Product in such country, the royalty rates provided in Section 4.5(a) for such HBV Licensed Product shall be reduced in such country by [***] for such Calendar Quarter if the unit volume sales of all Generic Products in such country as a percentage of the total unit volume sales of such HBV Licensed Product (other than Generic Products) and all such Generic Products in such Calendar Quarter in such country is [***] as a percentage of the total unit volume sales of such HBV Licensed Product (other than Generic Products) and all such Generic Products in such Calendar Quarter in such country [***]. Percentage of unit sales of HBV Licensed Product and Generic Products shall be based on data provided by IMS Health Incorporated, Fairfield, Connecticut (or, with respect to any region, such other independent data provider as the Parties determine, in good faith, provides more accurate data than IMS Health Incorporated, Fairfield, Connecticut) or if such data is not available, the Parties shall agree upon a methodology for estimating the percentage of unit sales based on market share of such Generic Product(s) in such region.
(iii)Third Party Licenses. If Vir Bio or its Related Parties is required to obtain a license from a Third Party under any Patent Rights of such Third Party that [***] (excluding any Patent Rights Covering any Unlicensed Component of a Combination Product), then Vir Bio shall have the right to credit [***] of the amount of the payments actually paid by it or its Related Parties to such Third Party pursuant to such license only to the extent such payments are reasonably attributable or allocable to the Development, Manufacture, use or Commercialization of such HBV Licensed Product (excluding any Unlicensed Component of a Combination Product) in the Field and the Territory, against [***] owed to Alnylam hereunder with respect to such HBV Licensed Product.
(iv)Royalty Floor. Notwithstanding the foregoing clauses (i)-(iii), with respect to any HBV Licensed Product in any Calendar Quarter, the operation of clause (i), (ii), and (iii) above, individually or in combination, shall not reduce by more than [***] the royalties that would otherwise have been due under Section 4.5(a) (for clarity, in each case without giving effect to any royalty or royalty rate reduction provided in clause (i), (ii) and (iii) above) with respect to Net Sales of such HBV Licensed Product during such Calendar Quarter. Vir Bio may carry forward to subsequent Calendar Quarters any amounts that it was not able to credit under Section 4.5(d)(iii) on account of such royalty floor, subject to the royalty floor for all subsequent Calendar Quarters.
(e)Royalty Payments for Compulsory Licenses and Global Access Programs.
(i)Sales of HBV Licensed Products pursuant to a Compulsory License or Global Access Program shall not be included in any Net Sales calculation for purposes of Section 4.5(a) and no royalties or milestones shall be payable on such Net Sales.
(ii)With respect to each HBV Licensed Product, for each Calendar Year commencing with the Calendar Year in which the First Commercial Sale of such HBV Licensed Product occurs, Vir Bio shall pay to Alnylam a royalty on all Compulsory License Compensation received by Vir Bio or its Related Parties from a Compulsory Licensee during the Royalty Term (the “Compulsory License Royalty Rate”) calculated for the respective Calendar Year as follows: [***]
At the end of the Calendar Year, Vir Bio shall pay to Alnylam the Compulsory License Compensation received for an HBV Licensed Product for a given country in the Territory multiplied by the applicable Compulsory License Royalty Rate.
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(iii)With respect to Net Sales of an HBV Licensed Product in a country pursuant to a Global Access Program in a given Calendar Year, if the aggregate such Net Sales of such HBV Licensed Product in such country during such Calendar Year are [***], then Vir Bio shall pay Alnylam a [***] royalty on such Net Sales. Such royalty shall not be subject to adjustment pursuant to Section 4.5(d).

4.6Program Transaction Revenue. Subject to the terms and conditions of this Agreement, as partial consideration for the licenses and other rights granted by Alnylam to Vir Bio in this Agreement, Vir Bio shall pay to Alnylam a percentage of all Program Transaction Revenue, which percentage shall be determined based on the date of the Program Transaction generating such Program Transaction Revenue with respect to an HBV Licensed Product as follows: [***]
Such payment is due within [***] after receipt of the applicable Program Transaction Revenue by Vir Bio or its Affiliate; provided, that payment is not due immediately if the Person receiving the sublicense, assignment or grant constituting the Program Transaction is a wholly-owned subsidiary of Vir Bio, but is due if and when such Person ceases to be a wholly-owned subsidiary of Vir Bio.
4.7Vir Bio-Brii Bio Agreement. Vir Bio and Alnylam agree that in lieu of receiving a royalty on Net Sales of HBV Licensed Products by Brii Bio pursuant to Section 4.5 of this Agreement and as agreed in the Vir Bio-Alnylam Letter Agreement, and notwithstanding Section 4.6 above, Alnylam will receive [***] of all Program Transaction Revenue received by Vir Bio or its Affiliates in connection with the Brii Bio-Vir Bio Agreement. For clarity, such Program Transaction Revenue will include any payments based on Net Sales, notwithstanding clause (a) of the Program Transaction Revenue definition, including, but not limited to, any royalty payments or sales-based milestone payments received by Vir Bio pursuant to Section 10.4 or Section 10.5 of the Vir Bio-Brii Bio Agreement. As between the Parties, Vir Bio is responsible for all payments to Brii under the Vir Bio-Brii Bio Agreement.
4.8Payments. Vir Bio shall calculate royalties on Net Sales quarterly as of March 31, June 30, September 30 and December 31 (each being the last day of an “Accounting Period”) and shall pay royalties on Net Sales of HBV Licensed Products within [***] after the end of each Accounting Period in which such Net Sales occur. Royalties on applicable Net Sales shall be paid by Vir Bio in Dollars. All calculations of payments under this Agreement shall be made in accordance with the Applicable Accounting Standards.
4.9Reporting. Within thirty (30) days following the end of each Accounting Period, Vir Bio shall provide in writing for the relevant Accounting Period the following information on an HBV Licensed Product-by-HBV Licensed Product, and country-by-country basis: (a) Net Sales, (b) any deductions from gross amounts received to determine Net Sales, (c) calculation of any applicable royalty or royalty rate reduction pursuant to Section 4.5(d), [***] (d) calculation of any royalty payment pursuant to Section 4.5(e), [***], (e) the applicable royalty rates for such HBV Licensed Product, (f) the exchange rates used in calculating any of the foregoing, and (g) the total royalties payable for the applicable period, in each case in reasonable detail to enable Alnylam to confirm the accuracy of the royalty calculation and as existing and not unduly burdensome to Vir Bio. In addition, within three (3) Business Days following the end of each Accounting Period beginning with the Accounting Period in which the First Commercial Sale of the HBV Licensed Product occurs in the Territory, Vir Bio will provide a preliminary report of a good faith estimate of the Net Sales and total royalties payable to Alnylam.
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4.10Audits. Each Party shall keep, and shall require its Affiliates and sublicensees to keep, complete and accurate records of the latest [***] relating to Net Sales sufficient to allow amounts payable under this Agreement to be determined, and each Party shall keep and require its Affiliates to keep complete and accurate records of the latest [***] relating to Net Sales and all information relevant to calculating the foregoing. For the sole purpose of verifying amounts payable hereunder or for calculating Net Sales, as applicable, each Party shall have the right, no more than [***] per Calendar Year (absent evidence of breach or fraud), at such Party’s expense, to retain an independent certified public accountant selected by the auditing Party and reasonably acceptable to the audited Party, to review such records in the location(s) where such records are maintained by the audited Party, its Affiliates and sublicensees upon [***] prior written notice and during regular business hours. Any such auditor shall execute a confidentiality agreement with the audited Party in customary form and shall not disclose the audited Party’s Confidential Information to the auditing Party, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished the audited Party or the amount of payments by the audited Party under this Agreement. The right to audit any royalty report or payment shall extend for [***] from the end of the Accounting Period to which such royalty report or such payment relates, provided that absent evidence of breach or fraud, any Accounting Period may be audited no more than [***]. All records made available for audit shall be deemed to be Confidential Information of the audited Party. The results of each audit, if any, shall be binding on both Parties. The audited Party shall promptly pay the auditing Party the amount of any underpayment revealed by such audit together with interest calculated in the manner provided in Section 4.15. If the underpayment is equal to or greater than [***] of the amount that was otherwise due, the auditing Party shall be entitled to have the audited Party reimburse the auditing Party’s reasonable out-of-pocket costs of such review. The auditing Party shall promptly return to the audited Party any overpayment revealed by such audit.
4.11Currency Exchange. With respect to sales of HBV Licensed Products invoiced in Dollars, the sales and royalties payable shall be expressed in Dollars. With respect to sales of HBV Licensed Products invoiced in a currency other than Dollars, the sales and any amounts payable hereunder on such sales shall be expressed in their Dollar equivalent calculated using a Party’s own standard currency translation methodology for the conversion of foreign sales currencies into Dollars, which methodology shall be in accordance with the Applicable Accounting Standards and shall be the methodology generally used by a Party for currency conversions in such Party’s audited financial statements.
4.12Manner of Payment. Any payment to be made by one Party to the other under this Agreement shall be payable in Dollars and shall be paid by wire transfer in immediately available funds to the bank account designated by the relevant Party. Either Party shall have the right to change such information at any time by providing written notice to the other Party; provided, that such new bank information shall not be deemed effective until the date that is [***] after the receipt of such new information.
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4.13Tax Withholding. Each Party shall use reasonable efforts to minimize tax withholding, including any interest and penalties that may be imposed thereon (together with the tax paid, the “Withholding Amount”), on payments made to the other Party and whenever possible to make such payments from a United States Person if Party is a United States Person. If such Party concludes that the Withholding Amount under the Laws of any country are required with respect to payments to the other Party, such Party shall use reasonable efforts to notify the other Party and provide such Party the opportunity to determine whether there are actions such receiving Party can undertake to avoid such withholding before the paying Party makes such payment. Any amount so withheld shall be treated as paid to the other Party in accordance with the terms of this Agreement. The paying Party shall make such payment and withhold the required amount and pay it to the appropriate Governmental Authority in a timely manner in compliance with applicable Law. In such case, the withholding Party shall promptly provide the other Party with copies of receipts or other evidence available to the withholding Party that are reasonably required and sufficient to allow the other Party to document such Withholding Amounts adequately for purposes of claiming foreign tax credits and similar benefits. At the receiving Party’s expense and reasonable request, the Parties will use reasonable efforts to cooperate in completing and filing documents required under the provisions of any applicable tax laws or under any other applicable Law, in connection with any claim to a refund of or credit for any such payment. The Parties will cooperate in completing and filing documents required under the provisions of any applicable tax laws in connection with the making of any required Withholding Amounts. In the event that a Governmental Authority retroactively determines that a payment made pursuant to this Agreement should have been subject to Withholding Amounts, and the payor remits such Withholding Amounts, if the payor has been compliant with applicable Law in a timely manner, then the payor will have the right: (a) to offset the Withholding Amount against future payment obligations of the payor under this Agreement; (b) to invoice the payee for the Withholding Amount (which will be payable by the payee within [***] of its receipt of such invoice); or (c) to pursue reimbursement of the Withholding Amount by any other available remedy. Notwithstanding the foregoing, if, as a result of (i) the assignment of this Agreement by the paying Party to an Affiliate or a Third Party outside of the United States or (ii) the exercise by the paying Party of its rights under this Agreement through an Affiliate or Third Party outside of the United States, foreign withholding tax in excess of the foreign withholding tax amount that would have been payable in the absence of such assignment or exercise of rights becomes payable with respect to amounts due to the payee hereunder, such amount due to the payee will be increased so that the amount actually paid to the payee (after withholding of the excess withholding tax) equals the amount that would have been payable to the payee in the absence of such excess withholding.
4.14Other Tax Liability. In the case of value added or similar taxes incurred by a Party with respect to payments made to a Party hereunder or the activities underlying such payments (the “VAT”), each Party and its Affiliates will use reasonable efforts to secure available exemption(s) from VAT and/or to cooperate with the other Party’s efforts to obtain maximum recovery of VAT paid or incurred by such Party or any Affiliate, to the extent permitted by applicable Law.
4.15Late Payments. The paying Party shall pay interest to the other Party on the aggregate amount of any payments (except for those payments which are the subject of a reasonable, good faith dispute) that are not paid on or before the date such payments are due under this Agreement at a rate of [***] from the due date until paid in full or the highest rate permitted by applicable Law, calculated on the number of days such payments are paid after the date such payments are due. In the event that the paying Party in reasonable good faith disputes any amounts due under this Agreement, the interest rate in the preceding sentence shall not apply to the amounts so disputed during the period of time that the Parties are resolving such dispute.
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4.16Blocked Payments. If, by reason of Laws in any jurisdiction in the Territory, it becomes impossible or illegal for a Party to transfer milestone payments, royalties or other payments under this Agreement to the other Party, the payor shall promptly notify the payee. During any such period described above, the payor shall deposit such payments in local currency in the relevant jurisdiction to the credit of the payee in a recognized banking institution designated by the payee or, if none is designated by the payee within a period of [***], in a recognized banking institution selected by the payor and identified in a written notice given to the payee.
5INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS.
5.1Inventorship. Inventorship for patentable inventions conceived or reduced to practice during the course of the performance of activities pursuant to this Agreement shall be determined in accordance with United States patent laws for determining inventorship.
5.2Ownership. Alnylam shall own the entire right, title and interest in and to all inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, solely by employees or consultants of Alnylam or acquired solely by Alnylam in the course of conducting the Collaboration. Vir Bio shall own the entire right, title and interest in and to all inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, solely by employees or consultants of Vir Bio or acquired solely by Vir Bio in the course of conducting the Collaboration. The Parties shall jointly own any inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, jointly in the course of conducting the Collaboration.
5.3Prosecution and Maintenance of Patent Rights.
(a)Vir Bio Intellectual Property. Vir Bio has the sole right and responsibility to, at Vir Bio’s discretion, file, conduct prosecution, and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising Vir Bio Intellectual Property (other than Joint Collaboration IP), in Vir Bio’s name.
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(b)Alnylam Intellectual Property.
(i)Subject to Sections 5.3(b)(ii) and 5.3(b)(iii), (A) [***] has the sole right and responsibility to, at [***] discretion, file, conduct prosecution, and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising Alnylam Intellectual Property (other than (1) Joint Collaboration IP, (2) any Alnylam Product-Specific Patent Rights, or (3) Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP), in [***] name, (B) [***] shall have the first right (but not the obligation) and responsibility to, at [***] discretion, to file, conduct prosecution, maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges) any Alnylam Product-Specific Patent Rights, and (C) [***] shall have the sole right and responsibility to, at [***] discretion, file, conduct prosecution, and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges) any Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP. [***] agrees to [***] prosecute and maintain such Alnylam Patent Rights in subsection (A) above in the Major Markets, and Vir Bio will prosecute and maintain Alnylam Product-Specific Patent Rights and Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP in [***] all other countries [***]. Notwithstanding the foregoing, Alnylam and Vir Bio shall jointly agree (not to be unreasonably withheld) on the preparation and filing of any Alnylam Product-Specific Patent Rights and Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP with the objective of maximizing patent protection and commercial value for the HBV Licensed Products in the Field in the Territory.
(ii)[***] shall provide [***], sufficiently in advance for [***] to comment, with copies of all patent applications and other material submissions and correspondence intended to be filed with any patent counsel or patent authorities pertaining to Patent Rights comprising Alnylam Product-Specific Patent Rights and Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP, and Vir Bio shall consider in good faith and reasonably incorporate [***] reasonable and promptly provided comments and advice with respect to the prosecution or maintenance strategy with respect to such Patent Rights; provided, however, that if [***] determines in good faith that [***] comments or advice are not reasonable, [***] shall promptly notify [***] thereof and the Parties shall promptly use good faith efforts to resolve any such determination. [***] shall promptly provide [***] with copies of all material correspondence received from any patent counsel or patent authorities pertaining to Patent Rights comprising Alnylam Product-Specific Patent Rights. In addition, [***] shall promptly notify [***] in writing of any interference, opposition or any other pre- or post-grant proceeding or challenge for any Alnylam Core Technology Patent Right included in Alnylam Collaboration IP and any Alnylam Product-Specific Patent Right.
(iii)In the event that [***] elects not to seek or continue to seek or maintain patent protection on, or defend any Alnylam Product-Specific Patent Rights, [***], [***] shall notify [***] of such decision in [***] so as to permit [***] to decide whether to seek, prosecute, maintain, or defend such Patent Right [***], and [***] shall have the right (but not the obligation), at its expense, to seek, prosecute, maintain or defend in any country patent protection on such Alnylam Product-Specific Patent Rights [***]. [***] shall make available to [***] its documentation, and use Commercially Reasonable Efforts to make available its authorized attorneys, agents or representatives, and such of its employees, as are reasonably necessary to assist [***] in obtaining and maintaining or defending the patent protection described under this Section 5.3(b)(iii). [***] shall sign, or use Commercially Reasonable Efforts to have signed, all legal documents necessary to file and prosecute such patent applications or to obtain or maintain such patents.
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(c)Joint Collaboration IP.
(i)[***] shall have the first right to, at [***] discretion, file, prosecute and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising Joint Collaboration IP, in the names of both Alnylam and Vir Bio. [***] shall provide [***], sufficiently in advance for [***] to comment, with copies of all patent applications and other material submissions and correspondence intended to be filed with any patent counsel or patent authorities pertaining to Patent Rights comprising Joint Collaboration IP, and [***] shall consider in good faith [***] reasonable and promptly provided comments and advice with respect to the prosecution or maintenance strategy with respect to such Patent Rights; provided, however, that if [***] determines that [***] comments or advice are not reasonable, [***] shall promptly notify [***] thereof and the Parties shall promptly discuss such determination. [***] shall promptly provide [***] with copies of all material correspondence received from any patent counsel or patent authorities pertaining to Patent Rights comprising Joint Collaboration IP. Each Party shall sign, or use Commercially Reasonable Efforts to have signed, all legal documents necessary to file and prosecute patent applications or to obtain or maintain patents in respect of such Joint Collaboration IP, at its own cost.
(ii)In the event that [***] elects not to file or continue to prosecute or maintain patent protection on any Joint Collaboration IP in the Territory, [***] shall notify [***] of such decision in sufficient time so as to permit [***] to decide whether to seek, prosecute and maintain such Patent Right and to take any necessary actions without losing patent protection, and [***] shall have the right (but not the obligation), to file, prosecute and maintain in any country Patent Rights comprising Joint Collaboration IP in the names of both Alnylam and Vir Bio. [***] shall make available to [***] its documentation, and its authorized attorneys, agents or representatives, and such of its employees, as are reasonably necessary to assist [***] in obtaining and maintaining the patent protection described under this Section 5.3(c)(ii). [***] shall sign, or use Commercially Reasonable Efforts to have signed, all legal documents necessary to file and prosecute such patent applications or to obtain or maintain such patents.
5.4Cooperation. With respect to the rights granted to a Party under Sections 5.3(b) or 5.3(c), each Party hereby agrees: (a) to make its employees, agents and consultants reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable such Party to undertake patent prosecution; (b) to provide the other Party with copies of all material correspondence pertaining to prosecution with the patent offices; (c) to cooperate, if necessary and appropriate, with the other Party in gaining patent term extensions wherever applicable to Patent Rights licensed under this Agreement; and (d) to endeavor in good faith to coordinate its efforts with the other Party to minimize or avoid interference with the prosecution and maintenance of the other Party’s patent applications.
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5.5Patent Expenses. Except as provided below with respect to Alnylam Product-Specific Patent Rights and Patent Rights comprising Joint Collaboration IP in the Territory, the patent filing, prosecution and maintenance expenses incurred after the Effective Date with respect to Patent Rights comprised of Alnylam Intellectual Property and Vir Bio Intellectual Property shall be borne by each Party having the right to file, prosecute and maintain such Patent Rights under Section 5.3. The Parties shall agree on the selection of any outside counsel used to prepare and prosecute any new Alnylam Product-Specific Patent Rights not in existence as of the Restatement Effective Date, along with an anticipated budget [***]. If during the Term a bona fide conflict arises between [***], then the Parties shall use good faith efforts to resolve any such conflict and [***]. The Parties shall share [***] the out-of-pocket patent filing, prosecution and maintenance expenses incurred with respect to Patent Rights comprising Joint Collaboration IP and [***] shall reimburse [***] on a Calendar Quarter basis (and within [***] after receipt of an invoice) with respect to [***] of all of the reasonable and documented out- of-pocket Third Party patent filing, prosecution, and maintenance expenses incurred by [***] with respect thereto. Each Party shall keep complete and accurate records with respect to such amount required to be paid by the other Party, and such other Party shall have the right to audit such records in accordance with Section 4.10.
5.6Patent Term Extension. [***] comprising Joint Collaboration IP, to the extent applicable, that will be designed to maximize patent protection and commercial value for the HBV Licensed Products in the Field in the Territory, and the Parties, subject to the provisions of any Alnylam In-License, will seek patent term extensions, restorations, supplementary protection certificates and other extensions in all relevant countries in the Territory for such Patent Rights as selected by [***] in accordance with that strategy. If [***] determines not to so file for any extension, restoration or supplementary protection certificates for any of such Patent Rights in any relevant country of the Territory, it will give notice of such determination to Alnylam at least [***] prior to the date on which such a filing must be made or the right to do so is lost, and [***] will have the right to make such filing. Where required under national law, [***] will make the filings for such extensions, restorations and supplementary protection certificates for Alnylam Product-Specific Patent Rights and, as applicable, will make, or cooperate with [***] to make, the filing for Patent Rights comprising Joint Collaboration IP in the Territory, in each case as directed by [***]. Each Party will execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain any such extensions, restorations and supplementary protection certificates in the Territory.
5.7Third Party Infringement.
(a)Notices. Each Party shall promptly report in writing to the other Party any (a) known or suspected infringement of any Alnylam Intellectual Property or Vir Bio Intellectual Property, or (b) unauthorized use or misappropriation of any Confidential Information or Know-How of a Party by a Third Party of which it becomes aware, in each case to the extent such infringing, unauthorized or misappropriating activities involve, as to an HBV Licensed Product, a competing product in the Field (“Competitive Infringement”), and shall provide the other Party with all available evidence of such infringement, unauthorized use or misappropriation.
(b)Rights to Enforce.
(i)Vir Bio Intellectual Property. Vir Bio shall have the sole and exclusive right to initiate an infringement or other appropriate suit anywhere in the world against any Third Party as to any infringement, or suspected infringement of, any Patent Rights, or of any use or suspected use without proper authorization of any Know-How, comprising Vir Bio Intellectual Property (other than Vir Bio’s interest in Joint Collaboration IP). Vir Bio will consider in good faith any request from Alnylam to initiate an infringement or other appropriate suit against any Third Party with respect to a Competitive Infringement in the Territory of Vir Bio Intellectual Property (other than Vir Bio’s interest in Joint Collaboration IP); provided, however, that Vir Bio shall not be required to initiate any such suit or permit Alnylam to initiate any such suit.
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(ii)Alnylam Intellectual Property and Joint Collaboration IP. Subject to the provisions of any Existing Alnylam In-License set forth in Schedule A-1, any Alnylam In-Licenses designated as such pursuant to Section 3.6(b) and any Existing Alnylam Third Party Agreement: [***], or, (y) in each case with Alnylam’s prior written consent, any (A) Alnylam Core Technology Patent Rights (other than Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP), or (B) Alnylam Know-How (other than Alnylam’s interest in Joint Collaboration IP). With respect to the Alnylam Core Technology Patent Rights (other than Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP) and Alnylam Know-How (other than Alnylam’s interest in Joint Collaboration IP), [***] with respect to a Competitive Infringement in the Territory of any Alnylam Core Technology Patent Right (other than Alnylam Core Technology Patent Rights included in Alnylam Collaboration IP) or such Alnylam Know-How (other than Alnylam’s interest in Joint Collaboration IP); provided, however, that Alnylam shall not be required to initiate any such suit or permit Vir Bio to initiate any such suit unless, [***]. In such case, Alnylam will use reasonable and good faith efforts, subject to the applicable provisions of any Existing Alnylam In-License set forth in Schedule A-1, any Alnylam In-Licenses designated as such pursuant to Section 3.6(b) or any Existing Alnylam Third Party Agreement, to cooperate with Vir Bio to assert such Alnylam Core Technology Patent Rights or such Alnylam Know-How, as the case may be, in a manner that does not materially and adversely affect the scope of such Alnylam Core Technology Patent Rights or such Alnylam Know-How in such country.
(iii)Step-In Right. If within [***] after Vir Bio’s receipt of a notice of a Competitive Infringement with respect to any Alnylam Product-Specific Patent Right or Joint Collaboration IP (or at least [***] before the loss of the right to take an action as described in Section 5.7(b)(ii) and permitted hereunder with respect to such Competitive Infringement, except if Vir Bio has notified Alnylam in writing that it intends to, and actually does within a commercially reasonable time period, take action as described in Section 5.7(b)(ii) and permitted hereunder against such Competitive Infringement), Vir Bio does not take any action as described in Section 5.7(b)(ii) and permitted hereunder against such Competitive Infringement in the relevant country in the Territory, Alnylam may in its sole discretion, bring and control any legal action in connection therewith at its sole expense.
(c)Procedures; Expenses and Recoveries. The Party having the right to initiate any infringement suit under Section 5.7(b) above shall have the sole and exclusive right to select counsel for any such suit and shall pay all expenses of the suit, including attorneys’ fees and court costs and reimbursement of the other Party’s reasonable out-of-pocket expense in rendering assistance requested by the initiating Party. If required under applicable Law in order for the initiating Party to initiate and/or maintain such suit, or if either Party is unable to initiate or prosecute such suit solely in its own name or it is otherwise advisable to obtain an effective legal remedy, in each case, the other Party shall join as a party to the suit and will execute and cause its Affiliates to execute all documents, and take all actions, reasonably necessary for the initiating Party to initiate litigation and maintain such action. In addition, at the initiating Party’s request, the other Party shall provide other reasonable assistance to the initiating Party in connection with an infringement suit at no charge to the initiating Party except for reimbursement by the initiating Party of reasonable out-of-pocket expenses incurred in rendering such assistance. The non-initiating Party shall have the right to participate and be represented in any such suit under Section 5.7(b)(ii) or 5.7(b)(iii) by its own counsel at its own expense. If the Parties obtain from a Third Party, in connection with any such suit under Section 5.7(b)(ii) or 5.7(b)(iii), any damages, license fees, royalties or other compensation (including any amount received in settlement of such litigation), such amounts shall be allocated in all cases as follows:
(i)first, [***]; and
(ii)second, the balance shall be paid as follows: [***].
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5.8Trademarks. Vir Bio and its Related Parties have the sole right to use any trademark it owns or controls for HBV Licensed Products in the Territory at its sole discretion, and each Party and its Related Parties shall retain all right, title and interest in and to its and their respective corporate names and logos. Vir Bio will develop one or more Product Trademark(s) for use by Vir Bio and its Related Parties in the Territory to Commercialize HBV Licensed Products which have received Regulatory Approval in the Field in the Territory. Vir Bio (or its Related Parties, as appropriate) shall own all rights to such Product Trademarks and all goodwill associated therewith, throughout the Territory, and the rights to any Internet domain names incorporating the applicable Product Trademarks or any variation or part of such Product Trademarks used as its URL address or any part of such address. For the avoidance of doubt, neither Party shall have any right to use the other Party’s or the other Party’s Related Parties’ corporate names or logos in connection with Commercialization of HBV Licensed Products without the prior written consent of the other Party.
6CONFIDENTIAL INFORMATION.
6.1Nondisclosure Obligation.
(a)All Confidential Information disclosed by one Party (“Disclosing Party”) to the other Party (“Receiving Party”) hereunder shall be maintained in confidence by the Receiving Party and shall not be published or otherwise disclosed to a Third Party or used for any purpose except as expressly set forth herein without the prior written consent of the Disclosing Party. Each Party may use the other Party’s Confidential Information solely to the extent required to perform its obligations or exercise any rights under this Agreement. The confidentiality and non-use provisions of this Article 6 shall not apply to the extent that such Confidential Information:
(i)is known by the Receiving Party at the time of its receipt, and not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records;
(ii)is in the public domain or publicly known by use and/or publication before its receipt from the Disclosing Party (or, with respect to Joint Collaboration IP, before its development hereunder), or thereafter enters the public domain or becomes publicly known through no fault of the Receiving Party;
(iii)is subsequently disclosed to the Receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the Disclosing Party; or
(iv)is developed by the Receiving Party independently of Confidential Information received from the Disclosing Party (including any Joint Collaboration IP), as documented by the Receiving Party’s business records.
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(b)Notwithstanding the obligations of confidentiality and non-use set forth above and in Section 6.2 below, a Receiving Party may disclose Confidential Information disclosed to it, and disclose the existence and terms of this Agreement, to the extent such disclosure is reasonably required to (i) Related Parties, and its and their employees, directors, agents, consultants, advisors, and Third Party contractors who have a need to know such Confidential Information for the performance of its obligations in the Transaction Agreements (or for such entities to determine their interest in performing such activities) in accordance with this Agreement, in each case who are obligated to keep such Confidential Information confidential on terms no less stringent than those in this Section 6.1; (ii) Governmental Authorities or other Regulatory Authorities in order to obtain and maintain patents and regulatory approvals in accordance with this Agreement, or otherwise perform its obligations or exploit its rights under this Agreement; provided, that such Confidential Information shall be disclosed only to the extent reasonably necessary to do so; (iii) prosecuting or defending litigation, including responding to a subpoena in a Third Party litigation; (iv) the extent required by a court or administrative order or Law, including by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity; (v) any bona fide actual or prospective underwriters, investors, lenders, other financing sources, acquirers, permitted sublicensees, collaborators or strategic partners and to consultants and advisors of such Party, in each case who are obligated to keep such Confidential Information confidential on terms no less stringent than those in this Section 6.1; and (vi) Third Parties solely to the extent a Receiving Party is required to do so pursuant to the terms of an Alnylam In-License and subject to the terms of such Alnylam In-License.
If a Receiving Party is required by Law (including regulations promulgated by securities exchanges or listing entities) to disclose Confidential Information of the Disclosing Party pursuant to Sections 6.1(b)(ii), 9.1(b)(iii), or 9.1(b)(iv), such Party shall, to the extent permitted by Law, promptly inform the Disclosing Party of the disclosure that is being sought in order to provide the Disclosing Party an opportunity to challenge or limit the disclosure obligations and the Receiving Party shall endeavor in good faith, at the Disclosing Party’s expense, to secure confidential treatment of such Confidential Information and/or reasonably assist the Disclosing Party in seeking a protective order or other confidential treatment. Confidential Information that is required to be disclosed by Law shall remain otherwise subject to the confidentiality and non-use provisions of this Section 6.1 and Section 6.2. If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States, at least [***] in advance of any such filing such Party will provide the other Party with a copy of this Agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with a reasonable opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party’s reasonable and timely comments into consideration before so filing the Agreement.
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6.2Publication and Publicity.
(a)Publication. Vir Bio and Alnylam each acknowledge the other Party’s interest in publishing the results of the Collaboration. Except to the extent required by Law or Alnylam’s obligations to Third Parties under its clinical trial agreements existing as of the Effective Date, (i) [***], however, [***], and (ii) neither Party shall publish Development results relating to ALN-HBV without the prior written consent of the other Party. Each Party also recognizes the mutual interest in obtaining valid patent protection and in protecting trade secret information. Consequently, except for disclosures permitted pursuant to Section 6.1, 6.2(b)(i), 6.2(b)(iii) or 6.2(b)(iv), either Party wishing to make a publication or public presentation of Development results that contains the Confidential Information of the Disclosing Party shall deliver to the Disclosing Party a copy of any proposed written publication or presentation of Development results at least [***] prior to submission for publication or presentation. The Disclosing Party shall have the right (i) to propose modifications to the publication or presentation for patent reasons, trade secret reasons or business reasons, which proposals the publishing Party shall consider in good faith, and (ii) to request a reasonable delay in publication or presentation in order to protect patentable information in accordance with Article 5. Following the expiration of the applicable time period for review, the publishing Party shall be free to submit for publication or otherwise disclose to the public such results, subject to the procedures set forth in the remainder of this Section 6.2(a). If the Disclosing Party provides written notice to the publishing Party requesting a delay pursuant to clause (ii) in this Section 6.2(a), the publishing Party shall delay such submission or presentation for a period of an additional [***] to enable Alnylam to file patent applications on the disclosed subject matter. The publishing Party shall thereafter be free to publish or disclose such information, except that the publishing Party may not disclose any Confidential Information of the Disclosing Party in violation of Section 6.1. With respect to any proposed publications or disclosures by clinical investigators or academic or non-profit collaborators, such materials shall be subject to review under this Section 6.2 to the extent that Vir Bio or Alnylam, as the case may be, has the right and ability (after using Commercially Reasonable Efforts to obtain such right and ability) to do so.
(b)Publicity.
(i)Except as set forth in Section 6.1 above and clause (ii) below or expressly permitted by the terms of this Agreement, the terms of this Agreement may not be disclosed by either Party, and no Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Law.
(ii)Except as provided in Sections 6.1, 6.2(b)(i), 6.2(b)(iii) or 6.2(b)(iv), neither Party shall issue a press release or public announcement relating to this Agreement without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed, except that a Party may (A) once a press release or other public statement is approved in writing by both Parties, make subsequent public disclosure of the information contained in such press release or other written statement without the further approval of the other Party, and (B) issue a press release or public announcement as required, in the reasonable judgment of such Party, by Law, including by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity.
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(iii)Vir Bio may issue a press release or make a public disclosure relating to this Agreement or the Parties’ activities under this Agreement to the extent, in each case, that such disclosure describes the commencement and/or “top-line” results of Clinical Studies of an HBV Licensed Product, the achievement of any material Development events with respect to an HBV Licensed Product or the filing for or receipt of Regulatory Approval with respect to the HBV Licensed Product in the Territory, or amounts paid to Alnylam in respect of the achievement of any milestone events; provided that Vir Bio shall not disclose in any such press release or public disclosure any Confidential Information of Alnylam and provided further that, prior to issuing the press release or making the public disclosure, Vir Bio shall provide Alnylam with a copy of the press release or public disclosure.
(iv)Subject to Sections 6.2(b)(ii) and 6.2(b)(iii), Vir Bio and its Related Parties may make public announcements or disclosures reasonably necessary or useful to Develop or Commercialize the HBV Licensed Products in the Field in the Territory, including disclosures necessary to recruit subjects to clinical trials and disclosures to advertise, promote and otherwise Commercialize the HBV Licensed Products.
7.REPRESENTATIONS, WARRANTIES AND COVENANTS.
7.1Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Commitment Letter Date and also as of the Restatement Effective Date:
(a)Representations of Authority. It is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate right, power and authority to enter into this Agreement and to perform its obligations under this Agreement.
(b)Consents. All necessary consents, approvals and authorizations of all government authorities and other Persons required to be obtained by it as of the Commitment Letter Date and Restatement Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained.
(c)No Conflict. The execution and delivery of this Agreement and the performance of its obligations hereunder (i) do not violate or conflict with the provisions of its certificate of incorporation or by-laws, (ii) do not conflict with or violate any requirement of applicable Law effective as of the Commitment Letter Date, and (iii) do not and will not conflict with, violate, breach or constitute a default under any contractual obligations of it or any of its Affiliates existing as of the Commitment Letter Date and as of the Restatement Effective Date.
(d)Authorization and Binding Nature. The execution, delivery and performance of this Agreement and the performance of all obligations hereunder have been duly authorized by all requisite corporate action on the part of such Party and this Agreement constitutes valid and legally binding obligations of such Party, limited by applicable bankruptcy, insolvency, reorganization, moratorium and other Laws of general application affecting the enforcement of creditors’ rights generally and as may be limited by Laws relating to the availability of specific performance, injunctive relief or other equitable remedies.
(e)Employee Obligations. All of its employees, officers and consultants have executed agreements or have existing obligations under Law requiring assignment to such Party of all intellectual property and proprietary rights made during the course of and as the result of their association with such Party, and obligating such individuals to maintain as confidential the Confidential Information of such Party, of a Disclosing Party under this Agreement, and of a Third Party which such Party may receive.
(f)No Debarment. Neither it nor any of its Affiliates, nor its or their respective employees, have been Debarred or are subject to Debarment.

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7.2Representations, Warranties and Covenants of Alnylam. Except as provided in Schedule D, Alnylam represents and warrants to Vir Bio that, as of the Commitment Letter Date, and solely with respect to (i) Alnylam Intellectual Property existing as of the Commitment Letter Date; (ii) the HBV Licensed Products as such products are formulated and manufactured as of the Commitment Letter Date; and (iii) covenants during the Term as to the matters set forth in subsection (j):
(a)Ownership. (i) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to Vir Bio as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 3.6(c)) of the Original Agreement, the Alnylam Intellectual Property. (ii) Alnylam has the right to grant the licenses hereunder. (iii) The Alnylam Intellectual Property and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the HBV Licensed Products.
(b)Alnylam Patent Rights. (i) To Alnylam’s Knowledge as of the Commitment Letter Date, Schedule C-1 (as attached to the Original Agreement on the Effective Date) sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights. (ii) To Alnylam’s Knowledge as of the Commitment Letter Date, Schedule C-2 (as attached to the Original Agreement on the Effective Date) sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights. (iii) Schedules C-1 and C-2 (as attached to the Original Agreement on the Effective Date) collectively set forth a complete and accurate list of the Alnylam Patent Rights owned or Controlled by Alnylam or its Affiliates. Upon Vir Bio’s request, [***], Alnylam shall update Schedules C-1 and C-2. (iv) To Alnylam’s Knowledge as of the Commitment Letter Date, each issued Alnylam Patent Right remains in full force and effect. (v) Alnylam or its Affiliates (or, to Alnylam’s Knowledge as of the Commitment Effective Date), the applicable Third Party in the case of Existing Alnylam In-Licenses, Additional Alnylam In-License, and Existing Alnylam Third Party Agreements) have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights.
(c)Validity. (i) To Alnylam’s Knowledge as of the Commitment Letter Date, the Alnylam Patent Rights, are, or, upon issuance will be, valid and enforceable patents. (ii) Alnylam has not been served with or received any other written notice that a Third Party has challenged or threatened in writing to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right. (iii) Alnylam (or, to Alnylam’s Knowledge as of the Commitment Letter Date, the applicable Third Party in the case of Existing Alnylam In-Licenses, Additional Alnylam In-License, and Existing Alnylam Third Party Agreements) has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights.
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(d)(i) Section 1 and Section 2 of Schedule A (as attached to the Original Agreement on the Effective Date) set forth a complete and accurate list of all agreements that Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, have entered into on or prior to the Commitment Letter Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires (or may have licensed or acquired) any intellectual property rights owned or Controlled by Alnylam or its Affiliates that are reasonably necessary or useful to Develop, Manufacture or Commercialize HBV Licensed Products in the Field. (ii) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize HBV Licensed Products in the Field in the Territory, except for the non-exclusive licenses (or rights to obtain non-exclusive licenses) granted to Third Parties pursuant to the Existing Alnylam Third Party Agreements; (iii) In the two (2) year period immediately prior to the Commitment Letter Date, Alnylam and its Affiliates have not received any written notice from a Third Party pursuant to the terms of any Existing Alnylam Third Party Agreement to expand the field of use within such Third Party’s Existing Alnylam Third Party Agreement to include any Infectious Disease(s). (iv) Alnylam Controls all Know-How and Patent Rights licensed to Alnylam under the Existing Alnylam In-Licenses that are necessary or useful for Vir Bio to Develop, Manufacture and/or Commercialize HBV Licensed Products in the Field in the Territory.
(e)Alnylam has provided Vir Bio with true and complete copies of all Existing Alnylam In- Licenses, Additional Alnylam In-Licenses and Existing Alnylam Third Party Agreements; provided, however, that, (i) to the extent that the terms of any such agreements require Alnylam to redact any provisions thereof before providing such agreements, or relevant portion thereof, to Vir Bio, Alnylam has provided Vir Bio with copies of such agreements, that are true and complete to the fullest extent possible under such agreements and that any provisions or portions which have not been provided to Vir Bio are not relevant to any obligations owed by Vir Bio, or rights granted to Vir Bio, under such agreement or this Agreement; and (ii) Alnylam is not required by this Section 7.2(e) to provide to Vir Bio copies of any amendment or side letter to any Existing Alnylam In-License, Additional Alnylam In-License or Existing Alnylam Third Party Agreement that is not relevant to the rights granted to, and the obligations imposed on, Vir Bio under this Agreement.
(f)To Alnylam’s Knowledge as of the Commitment Letter Date, the research, Development, Manufacture, and Commercialization of HBV Licensed Products, as contemplated under this Agreement will not infringe any Patent Rights of any Third Party or misappropriate any Know-How of a Third Party, in each case in existence as of the Commitment Letter Date.
(g)There is no (i) claim, demand, suit, proceeding, arbitration, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, to Alnylam’s Knowledge as of the Commitment Letter Date, threatened against Alnylam or any of its Affiliates or (ii) judgment or settlement against or owed by Alnylam or any of its Affiliates, in each case in connection with the Alnylam Intellectual Property or any HBV Licensed Product. Alnylam shall not resolve any such claim, demand, suit, proceeding, arbitration, inquiry, investigation, or other legal action in any manner that would materially adversely impact the rights granted to Vir Bio hereunder, and shall be solely responsible for any amounts owed to a Third Party as a result thereof.
(h)The Development of HBV Licensed Products in the Territory to date by Alnylam has been conducted by Alnylam and its Affiliates and its subcontractors, in compliance (in all material respects) with all applicable Laws.
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(i)Alnylam shall use Commercially Reasonable Efforts to maintain each Existing Alnylam In-License in full force and effect to the extent such agreement relates to the rights granted to Vir Bio hereunder. If Alnylam receives any notice of material breach under an Existing Alnylam In-License such that it would materially adversely affect the rights of Vir Bio under this Agreement, and if Alnylam reasonably determines in good faith that it cannot or chooses not to cure or otherwise resolve any such alleged breach or default, then Alnylam shall notify Vir Bio of such determination; provided that Alnylam shall not make any such determination with respect to any alleged breach or default of a payment obligation for which Vir Bio is obligated to pay [***] pursuant to Section 3.6(d). [***]
7.3Additional Representations, Warranties and Covenants of Vir Bio. Vir Bio represents, warrants and covenants to Alnylam, as of the Restatement Effective Date, that (a) the Brii-Bio License is the only sublicense granted by Vir Bio and the sublicense rights are limited to the HBV Licensed Products, (b) Vir Bio will not amend or modify the Vir Bio-Brii Bio Agreement in any manner, or enter into any other agreement with Brii Bio, that would adversely affect any rights of Alnylam or its Affiliates with respect to the Vir Bio-Brii Bio Agreement, any HBV Licensed Product or to Program Transaction Revenue arising therefrom, except with Alnylam’s prior written consent, and (c) Vir Bio is not in breach of the Vir Bio-Brii Bio Agreement and Brii-Bio, to Vir Bio’s Knowledge, is not in material breach of the Brii Bio License
7.4No Warranties. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY, HBV LICENSED PRODUCT, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON- INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE HBV LICENSED PRODUCTS PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO THE HBV LICENSED PRODUCTS WILL BE ACHIEVED.
7.5Additional Covenants.
(a)Exclusivity.
(i)During the Term, but subject to this Agreement including Sections 3.1(d) and 3.7, neither Party nor its Affiliates will, without the prior written agreement of the other Party, alone or with or for an Affiliate or Third Party, develop or commercialize in any country of the Territory any [***] Directed to the Collaboration Target, other than an HBV Licensed Product pursuant to this Agreement (a “Competing Program”).
(ii)Notwithstanding the foregoing, in the event that after the Effective Date:
(A)a Change of Control of a Party is consummated and as a result of such Change of Control (x) a Third Party becomes an assignee of this Agreement or an Affiliate of such Party, and (y) such Third Party, as of the closing date of such Change of Control transaction, is engaged in the development or commercialization of a Competing Program, [***]; or
(B)a Party becomes an Affiliate of a Third Party as a result of a Change of Control of such Third Party, and as of the closing date of such Change of Control transaction such Third Party is engaged in the development or commercialization of a Competing Program, [***]. As used in this Section 7.4(a)(ii), [***].
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(b)Compliance. Vir Bio and its Related Parties shall conduct the Development, Manufacture and Commercialization of the HBV Licensed Products in material accordance with all Laws and industry standards, including, to the extent applicable, current governmental regulations concerning good laboratory practices, good clinical practices and good manufacturing practices. Neither Party shall export any technology licensed to it by the other Party under this Agreement except in compliance with U.S. export laws and regulations.
(c)Debarment. Neither Party nor any of its Affiliates will use in any capacity, in connection with the Development, Manufacture and Commercialization of the HBV Licensed Products or the performance of its obligations under this Agreement, any Person that has been Debarred. Each Party agrees to inform the other Party in writing promptly if it learns that it or any Person that is performing activities under this Agreement is Debarred or is subject to Debarment, or, to the notifying Party’s Knowledge, if Debarment of the notifying Party or any Person used in any capacity by such Party or any of its Affiliates in connection with the performance of its other obligations under this Agreement, is threatened.
8.TERM AND TERMINATION.
8.1Term. This Agreement shall be effective as of the Effective Date and, unless terminated earlier pursuant to Section 8.2, this Agreement shall continue in effect on an HBV Licensed Product-by-HBV Licensed Product and country-by-country basis until expiration of the last Royalty Term to expire under this Agreement (“Term”).
8.2Termination Rights.
(a)Termination for Convenience. Vir Bio shall have the right to terminate this Agreement in its entirety at any time after the one (1) year anniversary of the Effective Date on ninety (90) days’ prior written notice to Alnylam.
(b)Termination for Cause. This Agreement may be terminated at any time during the Term upon written notice by either Party (the “Non-Breaching Party”) if the other Party (the “Breaching Party”) is in material breach of its obligations hereunder and has not cured such breach within thirty (30) days in the case of a payment breach, or within sixty (60) days in the case of all other breaches, after notice requesting cure of the breach, or, if cure of such breach other than non-payment cannot reasonably be effected within such sixty (60) day period, to deliver to the Non-Breaching Party a plan reasonably calculated to cure such breach within a timeframe that is reasonably prompt in light of the circumstances then prevailing, but in no event more than [***]. Following delivery of such a plan, the Breaching Party will carry out the plan and cure the breach. If the Breaching Party fails to cure a material breach of this Agreement as provided above, then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party; provided that if the Breaching Party is Vir Bio and such material breach relates solely to one or more Programs under the Agreement (but not to all Programs), then Alnylam shall have the right to terminate this Agreement pursuant to this Section 8.2(b) solely with respect to such Program(s).
(c)Disputed Breach. If the alleged Breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the other Party in accordance with Section 8.2(b), or disputes that it has not timely cured such breach, and such alleged Breaching Party provides the other Party notice of such dispute within such sixty (60)-day period, then the Non-Breaching Party shall not have the right to terminate this Agreement under Section 8.2(b) unless and until such dispute is resolved in accordance with Article 10. It is understood and agreed that during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
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(d)Challenges of Patent Rights. In the event that a Party (the “Challenging Party”) or any of its Related Parties (i) commences or participates in any action or proceeding (including any patent opposition, re-examination or any other pre- or post-grant challenge or proceeding), or otherwise asserts any claim, challenging or denying the validity or enforceability (such an action or proceeding, a “Challenge”) of any of the Patent Rights licensed to such Challenging Party by the other Party (the “Licensor Party”) under this Agreement or any claim thereof or (ii) actively assists any other Person in bringing or prosecuting any action or proceeding (including any patent opposition, re-examination or any other pre- or post-grant challenge or proceeding) challenging or denying the validity or enforceability of any of such Patent Rights or any claim thereof, then (A) such Challenging Party shall give notice thereof to such Licensor Party within [***] of taking such action or of learning that its Related Party has taken such action, and (B) such Licensor Party will have the right, in its sole discretion, to give notice to such Challenging Party that this Agreement will terminate thirty (30) days following such notice (or such longer period as such Licensor Party may designate in such notice), and, unless, with respect to a Challenge brought by such Challenging Party, such Challenging Party withdraws, or, with respect to a Challenge brought by its Affiliates, causes, or, with respect to a Challenge brought by its Sublicensee, [***] within such thirty (30)-day (or longer) period, this Agreement will so terminate. In the event that such Licensor Party is not permitted under Law to terminate this Agreement as contemplated in this Section 8.2(d), then the Parties agree to construe this provision to permit such Licensor Party to terminate only the licenses to that portion of such Patent Rights with respect to which such Licensor Party may terminate consistent with Law.
8.3Effect of Termination. Without limiting any other legal or equitable remedies that either Party may have, if this Agreement is terminated by Alnylam or by Vir Bio in accordance with Section 8.2(a) then, with respect to the HBV Licensed Products Directed to the Collaboration Target that were Developed or Commercialized under this Agreement (the “Terminated Products”):
(a)If this Agreement is terminated by Alnylam, Vir Bio’s obligations under Section 7.5(a) shall survive for a period of [***] after the effective date of termination. If this Agreement is terminated by Vir Bio, Vir Bio’s obligations under Section 7.5(a) shall survive for a period of [***] after the effective date of termination;
(b)Subject to the terms and conditions of this Agreement and the agreement on financial terms as provided below in this subsection (a), Vir Bio shall and hereby does grant to Alnylam a transferable, sublicenseable (subject to Section 3.2(c)), worldwide, exclusive, royalty-bearing license, under any Vir Bio Collaboration IP solely to Develop, Manufacture, use, sell, have sold, import, and otherwise Commercialize the Terminated Products in the Field in the Territory. The licenses and other rights conveyed under this Section 8.3 shall be granted on commercially reasonable terms negotiated in good faith by the Parties, including commercially reasonable milestone and royalty payments. In connection with such grant, Alnylam shall be responsible for all payments owed to Third Parties in connection with any of the grant of rights described in this Section 8.3 for Alnylam’s Development, Manufacture, use, sale, import and other Commercialization of such Terminated Products. In the event that the Parties cannot mutually agree upon such terms within [***] following the effective date of termination, either Party may seek a final and binding resolution regarding the commercially reasonable terms of such definitive agreement pursuant to the baseball arbitration provisions in Section 10.3;
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(c)Vir Bio shall wind down or complete (whether to wind down or complete being in Vir Bio’s sole discretion subject to patient safety and well-being), at Vir Bio’s expense, all Clinical Studies ongoing at the effective date of termination and shall use Commercially Reasonable Efforts to [***] transfer to Alnylam or Alnylam’s designee (i) possession and ownership of all governmental or regulatory correspondence, conversation logs, filings and approvals (including all Regulatory Approvals and pricing and reimbursement approvals) in Vir Bio’s or its Affiliates’ possession and Control relating to the Development, Manufacture or Commercialization of the Terminated Products and all Product Trademarks, (ii) copies of all data, reports, records and materials, and other sales and marketing related information in Vir Bio’s or its Affiliates’ possession and Control to the extent that such data, reports, records, materials or other information relate to the Development, Manufacture or Commercialization of Terminated Products, including all non-clinical and clinical data relating to Terminated Products, and customer lists and customer contact information and all adverse event data in Vir Bio’s possession and Control, and (iii) all records and materials in Vir Bio’s possession and Control containing Confidential Information of Alnylam. Vir Bio shall further appoint Alnylam as Vir Bio’s and/or Vir Bio’s Affiliates’ agent for all Terminated Product-related matters involving Regulatory Authorities in the Territory until all such Regulatory Approvals and other regulatory filings have been transferred to Alnylam or its designee. To the extent that any of the foregoing items cover Terminated Products and other products, then Vir Bio shall exclusively license (not assign) such items to Alnylam for the Terminated Products and grant rights sufficient to give effect to Alnylam’s continued Development, Manufacture or Commercialization of such Terminated Products;
(d)If the effective date of termination is after First Commercial Sale, then Vir Bio shall appoint Alnylam as its exclusive distributor of the Terminated Product in the Territory and grant Alnylam the right to appoint sub-distributors, until the earlier of (i) [***] after the effective date of termination, or (ii) such time as all such Regulatory Approvals in the Territory have been transferred to Alnylam or its designee; provided, that Alnylam shall [***] complete such transfer as promptly as practicable;
(e)If Vir Bio or its Affiliates are Manufacturing or having Manufactured on its or their behalf the Terminated Product, then at Alnylam’s option, Vir Bio shall use Commercially Reasonable Efforts to supply the Terminated Product to Alnylam in the Territory at a supply price equal to [***], for a period of up to [***] after the effective date of termination provided, that Alnylam shall use Commercially Reasonable Efforts to obtain alternative supply of such Terminated Product as promptly as practicable. [***];
(f)If Alnylam so requests, Vir Bio shall use Commercially Reasonable Efforts to assign to Alnylam any Third Party agreements solely relating to the Development, Manufacture or Commercialization of the Terminated Product to which Vir Bio is a party, subject to any required consents of such Third Party, which Vir Bio shall use Commercially Reasonable Efforts to obtain promptly. Such assignment shall be subject to the terms of such agreement and Alnylam’s written agreement to assume all the obligations of Vir Bio under such agreement to be undertaken after such assignment, but Vir Bio shall remain solely responsible for its obligations under such agreement arising prior to such assignment;
(g)Vir Bio shall promptly transfer and assign to Alnylam all of Vir Bio’s and its Affiliates’ rights, title and interests in and to the Product Trademark(s) owned by Vir Bio or its Affiliates and solely used for the Terminated Products in the Field in the Territory;
(h)Vir Bio shall transfer to Alnylam any inventory of Terminated Products Controlled by Vir Bio or its Affiliates as of the termination date, at a price equal to [***]; and
(i)For the [***] immediately following the effective date of termination, Vir Bio shall use [***]; provided, that that Alnylam shall use Commercially Reasonable Efforts to so proceed as expeditiously as practicable.

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(j)Vir Bio shall, [***], execute all documents and use Commercially Reasonable Efforts to take all such further actions as may be reasonably requested by Alnylam in order to give effect to the foregoing clauses.
(k)Notwithstanding the foregoing, in the event of the termination of this Agreement by Alnylam pursuant to Section 8.2(b) or Section 8.2(d), any sublicense granted by Vir Bio or its Affiliates to a Sublicensee shall survive the termination of this Agreement and Alnylam and such Sublicensee shall enter into a direct license, taking into account any difference in license scope, territory and duration of sublicense grant; provided that (i) such Sublicensee did not cause such uncured material breach of this Agreement or Challenge, as applicable, and is not otherwise then in uncured material breach of the applicable sublicense or the terms of this Agreement applicable to such Sublicensee, (ii) Alnylam shall have no obligations under such direct license to the Sublicensee beyond the obligations of Alnylam expressly set forth in this Agreement, and (iii) such Sublicensee will be required to pay to Alnylam the same amounts in Milestone Payments, Sales Milestones, royalties, and Program Transaction Revenue for such direct grant as Alnylam would have otherwise received from Vir Bio for the Development, Manufacture, or Commercialization of HBV Licensed Products had this Agreement not been terminated.
8.4Effect of Expiration or Termination; Survival. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued under this Agreement prior to expiration or termination, including the obligation to pay royalties for any HBV Licensed Product sold prior to such expiration or termination. The following provisions shall survive any expiration or termination of this Agreement: Articles 1 (Definitions), 9 (Indemnification), 10 (Dispute Resolution), and 11 (Miscellaneous) and Sections 2.4, 3.2(a), 3.2(b) (to the extent applicable), 3.3, 3.4 (to the extent applicable), 3.5, 3.6(d) (to the extent reimbursement obligations are incurred prior to the effective date of termination), 3.7, 4.8 (to the extent payment obligations are incurred prior to the effective date of termination), 4.9, 4.10, 4.11, 4.12, 4.13, 4.14, 4.15, 4.16, 5.1, 5.2, 5.7(c), 6.1, 7.4 and 8.3 (solely to the extent applicable), and this 8.4 shall survive any expiration or termination of this Agreement. Except as set forth in this Article 8, upon termination or expiration of this Agreement all other rights and obligations of the Parties under this Agreement cease.
9.INDEMNIFICATION.
9.1General Indemnification.
(a)By Vir Bio. Except as expressly otherwise set forth in a Transaction Agreement, Vir Bio shall indemnify, hold harmless, and defend Alnylam, its Affiliates, and their respective directors, officers, employees and agents (“Alnylam Indemnitees”) from and against any and all Third Party claims, suits, losses, liabilities, damages, costs, fees and expenses (including reasonable attorneys’ fees) (collectively, “Losses”) to the extent such Losses arise out of or result from, directly or indirectly, (i) any breach of any representation or warranty made by Vir Bio in the Transaction Agreements or any breach of any covenant or agreement of Vir Bio in the Transaction Agreements, (ii) the negligence or willful misconduct of Vir Bio and its Related Parties, and their respective directors, officers, employees and agents, in the performance of Vir Bio’s obligations under the Transaction Agreements, or (iii) the Development, Manufacture or Commercialization of HBV Licensed Products by Vir Bio or its Related Parties, contractors, or distributors. Notwithstanding the foregoing, Vir Bio shall have no obligation to indemnify the Alnylam Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, (1) any breach of any representation or warranty made by Alnylam in the Transaction Agreements, (2) any breach of any covenant or agreement of Alnylam in the Transaction Agreements, (3) the negligence or willful misconduct of any of the Alnylam Indemnitees or any other Alnylam Related Parties and their respective directors, officers, employees and agents, or (4) or the Development, Manufacture, or Commercialization of HBV Licensed Products by Alnylam or its Related Parties, contractors, or distributors.
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(b)By Alnylam. Except as expressly otherwise set forth in a Transaction Agreement, Alnylam shall indemnify, hold harmless, and defend Vir Bio, its Affiliates and their respective directors, officers, employees and agents (“Vir Bio Indemnitees”) from and against any and all Losses to the extent such Losses arise out of or result from, directly or indirectly, (i) any breach of any representation or warranty made by Alnylam in the Transaction Agreements or any breach of any covenant or agreement of Alnylam in the Transaction Agreements, (ii) the negligence or willful misconduct of Alnylam and its Affiliates, and their respective directors, officers, employees and agents, in the performance of Alnylam’s obligations under the Transaction Agreements, (iii) the Development or Manufacture of HBV Licensed Products by Alnylam or its Related Parties, contractors, or distributors, (iv) the exercise by Alnylam or its Related Parties of its rights in Section 3.2(a), or (v) the Development, Manufacture, or Commercialization of Terminated Products by Alnylam or its Related Parties, contractors, or distributors. Notwithstanding the foregoing, Alnylam shall have no obligation to indemnify the Vir Bio Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, (1) any breach of any representation or warranty made by Vir Bio in the Transaction Agreements, (2) any breach of any covenant or agreement of Vir Bio in the Transaction Agreements, (3) the negligence or willful misconduct of any of the Vir Bio Indemnitees or any other Vir Bio Related Parties and their respective directors, officers, employees and agents, or (4) the Development, Manufacture or Commercialization of HBV Licensed Products by Vir Bio or its Related Parties, contractors, or distributors.
9.2Indemnification Procedure. In the event of any such claim against any Vir Bio Indemnitee or Alnylam Indemnitee, the indemnified Party shall promptly notify the other Party in writing of the claim once the indemnified Party learns of it, and the indemnifying Party shall manage and control, at its sole expense, the defense of the claim and its settlement. The indemnified Party shall cooperate with the indemnifying Party, at the indemnifying Party’s reasonable request and expense, in the preparation and defense of the claim, and may, at the indemnified Party’s option and expense, be represented by counsel of its own choosing in any such action or proceeding. The indemnifying Party shall not be liable for any settlements, litigation costs or expenses incurred by any the indemnified Party without the indemnifying Party’s prior written authorization. The indemnifying Party shall not settle any such claim without the indemnified Party’s consent, not to be unreasonably withheld, conditioned, or delayed, unless such settlement requires only payments by the indemnifying Party and no admission of wrong-doing or fault by the indemnified Party. Notwithstanding the foregoing, if the indemnifying Party reasonably believes that any of the exceptions to its obligation of indemnification of the indemnified Party set forth in Section 9.1 may apply, the indemnifying Party shall promptly notify the indemnified Party, which shall then have the right to be represented in any such action or proceeding by separate counsel at its own expense; provided, that the indemnifying Party shall be responsible for payment of such expenses if the indemnified Party is ultimately determined to be entitled to indemnification from the indemnifying Party for the matters to which the indemnifying Party notified the indemnified Party that such exception(s) may apply.
9.3General Limitation of Liability. NEITHER PARTY HERETO WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF A PARTY’S WILLFUL MISCONDUCT, A MATERIAL BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN ARTICLE 6. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.3 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 9.1.
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9.4Insurance. Each Party shall maintain insurance during the Term and for a period of at least [***] after the last commercial sale of any HBV Licensed Product under this Agreement by such Party or its Related Parties, with a reputable, solvent insurer in an amount appropriate for its business and products of the type that are the subject of this Agreement, and for its obligations under this Agreement. Specifically, Vir Bio shall maintain product liability insurance of at least [***] per occurrence prior to the Initiation of Clinical Studies by Vir Bio, and at least [***] per occurrence thereafter. Upon reasonable request, each Party shall provide the other Party with evidence of the existence and maintenance of such insurance coverage.
10.DISPUTE RESOLUTION.
10.1Dispute Resolution. Should a dispute arise under this Agreement or any other Transaction Agreement that the Parties are not initially able to resolve, such dispute shall be referred to the Executive Officers (or their designees), who shall promptly initiate discussions in good faith to resolve such dispute. If such dispute is not resolved by the Executive Officers within ninety (90) days after the date the Executive Officers first met to consider such dispute, and a Party wishes to pursue the matter, then except as otherwise expressly provided for in this Agreement or any other Transaction Agreement, such Party may file suit to have such dispute adjudicated in a court of competent jurisdiction or the Parties may mutually agree to resolve such dispute in accordance with Section 10.2.
10.2Arbitration.
(a)If the Parties do not resolve a dispute as provided in Section 10.1 and mutually agree to resolve such dispute through binding arbitration, then unless such dispute is an Excluded Claim, such dispute shall be resolved by binding arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce as then in effect (the “ICC Rules”), which ICC Rules are deemed to be incorporated by reference into this clause and judgment on the arbitration award may be entered in any court having jurisdiction thereof. The decision rendered in any such arbitration will be final and not appealable.
(b)The arbitration shall be conducted by a panel of three (3) arbitrators appointed in accordance with the ICC Rules, none of whom shall be a current or former employee or director, or a then- current stockholder, of either Party, their respective Affiliates, or any Sublicensee. The place of arbitration shall be [***], and all proceedings and communications shall be in English.
(c)It is the intention of the Parties that discovery, although permitted as described herein, will be limited except in exceptional circumstances. The arbitrators will permit such limited discovery necessary for an understanding of any legitimate issue raised in the arbitration, including the production of documents. No later than [***] after selection of the arbitrators, the Parties and their representatives shall hold a preliminary meeting with the arbitrators, to mutually agree upon and thereafter follow procedures seeking to assure that the arbitration will be concluded within [***] from such meeting. Failing any such mutual agreement, the arbitrators will design and the Parties shall follow procedures to such effect.
(d)Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. The arbitrators shall [***]. The arbitrators shall have the power to order that all or part of the legal or other costs incurred by a Party in connection with the arbitration be paid by the other Party. Any determination pursuant to this Section 10.2 that a Party is in material breach of its material obligations hereunder shall [***]. Each Party shall bear an equal share of the arbitrators’ and any administrative fees of arbitration.

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(e)Except to the extent necessary to confirm or enforce an award or as may be required by applicable Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy, or claim would be barred by the applicable New York statute of limitations.
(f)As used in this Section, the term “Excluded Claim” shall mean a dispute, controversy, or claim that concerns [***]. Disputes regarding Excluded Claims shall be brought in a court of competent jurisdiction in which such patent or trademark rights or copyright was granted or arose or in which such law or regulation applies.
10.3Baseball Arbitration. Notwithstanding the provisions of Section 10.1, any dispute for which arbitration pursuant to this Section 10.3 is specifically provided for in this Agreement shall be finally decided by expedited arbitration in accordance with the following abbreviated dispute resolution procedures:
(a)If the dispute is not resolved within [***] after referral to the Party’s respective Executive Officers, then either Party may send the other Party a written notice that it wishes to resolve the dispute by using a neutral Third Party who is an expert with at least [***] of experience in area of the dispute (the “Neutral Expert”). The date of the other Party’s receipt of such written notices shall be the “Notice Date.”
(b)Within [***] of the Notice Date, each Party shall notify the other Party in writing of its appointed Expert (each, a “Representative Expert”). The Representative Experts for each Party shall jointly appoint the Neutral Expert within [***].
(c)Within [***] after the appointment of the Neutral Expert, each Party shall submit to the other Party and the Neutral Expert a written summary regarding its position with respect to the dispute. Contemporaneously with the submission of its written summary regarding its position, each Party shall provide the other Party and the Neutral Expert with copies of all documents it relied upon in its written summary; provided that each Party may redact any portion of such documents which are covered by an applicable privilege or do not relate to the subject matter of this Agreement. Within [***] of receipt of the other Party’s written summary regarding its position, each Party may submit an opposition statement of no more than [***] in length (excluding exhibits and declarations). Neither Party will be allowed to conduct any discovery. Neither Party may have any communications (either written or oral) with the other Party’s Representative Experts or the Neutral Expert other than for the sole purpose of engaging the expert panel or as expressly permitted in this Section 10.3; provided, that oral presentations and follow-up written submissions may be made to the Neutral Expert at such Neutral Expert’s request. The Neutral Expert may consult in writing with the Representative Experts regarding the submissions made by either Party; provided that both Representative Experts are aware of such consultation and provided an opportunity to respond. Evaluating each Party’s written submissions, the Neutral Expert shall, within [***] of receipt of the written opposition statement, select in total, either Vir Bio’s submission or Alnylam’s submission. Such decision shall be final, binding, and not appealable.
(d)[***]
11.MISCELLANEOUS.
11.1Governing Law. This Agreement shall be construed and the respective rights of the Parties determined according to the substantive laws of the State of New York, U.S.A., excluding (a) any of its conflicts of laws principles to the contrary; (b) the United Nations Conventions on Contracts for the International Sale of Goods; (c) the 1974 Convention on the Limitation Period in the International Sale of Goods; and (d) the Protocol amending the 1974 Convention on the Limitation Period in the International Sale of Goods, done at Vienna, April 11, 1980.
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11.2Waiver of Jury Trial. The Parties hereby (a) irrevocably submit to the jurisdiction of the state and federal courts in the State of New York and agree that all claims shall be heard and determined in any such court; (b) waive any defense of inconvenient forum to the maintenance of any such claims and further agree not to bring any such claims in any other court; (c) irrevocably consent to service of process by certified mailing, postage prepaid, or delivering such service to the Party at its respective notice address set forth in Section 11.5; (d) waive any right to a trial by jury in any action or proceeding to enforce or defend any rights under this Agreement or under any amendment, instrument, document or agreement delivered in connection herewith or hereafter and agree that any such action or proceeding shall be tried before a court and not before a jury; and (e) agree that a final judgment shall be conclusive and may be enforced by suit on the judgment or in any other manner provided by law or at equity. Notwithstanding anything to the contrary in this Section 11.2, either Party may seek injunctive relief in any court in any jurisdiction where appropriate.
11.3Assignment. Except as provided in this Section 11.3, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. However, either Party may, without the other Party’s consent, assign or otherwise transfer this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate or to a Person that acquires, by merger, sale of assets or otherwise, all or substantially all of the business of the assigning Party to which the subject matter of this Agreement relates; provided, however, [***].
11.4Entire Agreement; Amendments. This Agreement, together with that certain Commitment Letter entered into by and between the Parties on the Commitment Letter Date and the Stock Purchase Agreement, contain the entire understanding of the Parties with respect to the subject matter hereof, and supersede all previous arrangements with respect to the subject matter hereof, whether written or oral, including the Confidential Disclosure Agreement. The Parties hereby agree and acknowledge that this Agreement amends and restates the Original Agreement in its entirety and the Original Agreement is replaced with, and superseded by, this Agreement, and any activities conducted under the Original Agreement shall be deemed to have been conducted under this Agreement (including that any claims for breach of, or indemnification under, the Original Agreement may be brought under this Agreement). This Agreement (including the Schedules hereto) may be amended, or any term hereof modified, only by a written instrument duly- executed by authorized representatives of both Parties.
11.5Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
Notices to Alnylam shall be addressed to: [***]
with a copy that shall not constitute notice to: [***]
Notices to Vir Bio shall be addressed to: [***]
with a copy that shall not constitute notice to: [***]
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) on receipt if sent by overnight courier; and/or (c) on receipt if sent by mail.
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11.6Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any Governmental Authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.
11.7No Strict Construction. This Agreement has been prepared jointly and shall not be strictly construed against any Party.
11.8Headings. The captions or headings of the Sections or other subdivisions hereof are inserted only as a matter of convenience or for reference and shall have no effect on the meaning of the provisions hereof.
11.9No Implied Waivers; Rights Cumulative. No failure on the part of Alnylam or Vir Bio to exercise, and no delay in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.
11.10Severability. If any provision hereof should be held invalid, illegal or unenforceable in any respect in any jurisdiction, the Parties shall substitute, by mutual consent, valid provisions for such invalid, illegal or unenforceable provisions, which valid provisions best reflect the original intent of the Parties and in their economic effect are sufficiently similar to the invalid, illegal or unenforceable provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions. In case such valid provisions cannot be agreed upon, the invalid, illegal or unenforceable of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid, illegal or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid, illegal or unenforceable provisions.
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11.11Interpretation. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” The word “will” shall be construed to have the same meaning and effect as the word “shall.” Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Laws herein shall be construed as referring to such Laws as they from time to time may be enacted, repealed or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns, (d) the words “herein”, “hereof’ and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) any reference herein to the words “mutually agree” or “mutual written agreement” shall not impose any obligation on either Party to agree to any terms relating thereto or to engage in discussions relating to such terms except as such Party may determine in such Party’s sole discretion, (f) all references herein to Articles, Sections, Exhibits or Schedules shall be construed to refer to Articles, Sections, Exhibits and Schedules of this Agreement, (g) the word “or” shall be construed to have the same meaning and effect as “and/or” unless the context dictates otherwise because the subjects of the conjunction are mutually exclusive, and (h) a term not defined herein but reflecting a different part of speech than a term which is defined herein shall be interpreted in a correlative manner.
11.12Actions of Affiliates. Each Party shall be liable for any failure by its Affiliates to comply with the restrictions, limitations and obligations set forth in this Agreement. Neither Party shall permit any of its Affiliates to commit any act (including any act of omission) that such Party is prohibited hereunder from committing directly. To the extent that the rights granted to a Party hereunder may be and are exercised by an Affiliate of such Party, such Affiliate shall be bound by the corresponding obligations of such Party.
11.13Relationship of the Parties. It is expressly agreed that Alnylam and Vir Bio are independent contractors and that the relationship between the two Parties will not constitute a partnership, joint venture, or agency. Neither Alnylam nor Vir Bio will have the authority to make any statements, representations, or commitments of any kind, or to take any action, which will be binding on the other Party, without the prior written consent of the other Party. Nothing contained in this Agreement shall be deemed to make a Party a partner, agent, or legal representative of the other Party, or to create any fiduciary relationship for any purpose whatsoever. Except as may be explicitly provided in this Agreement, neither Party will have any authority to act for, or to assume any obligation or responsibility on behalf of, the other Party.
11.14Binding Effect; No Third Party Beneficiaries. As of the Effective Date, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Except as expressly set forth in this Agreement, no Person other than the Parties and their respective Affiliates and permitted assignees hereunder shall be deemed an intended third party beneficiary hereunder or have any right to enforce any obligation of this Agreement.
11.15Further Assurances. Each Party agrees to duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including, without limitation, the filing of such additional assignments, agreements, documents and instruments, as the other Party may at any time and from time to time reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes of, or to better assure of and confirm unto such other Party its rights and remedies under, this Agreement.
11.16Counterparts. The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures and signatures transmitted via PDF shall be treated as original signatures.
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IN WITNESS WHEREOF, Alnylam and Vir Bio have caused this Agreement to be duly executed by their authorized representatives, as of the Restatement Effective Date.
ALNYLAM PHARMACEUTICALS, INC.    VIR BIOTECHNOLOGY, INC.


By:     /s/ Jeff PoultonBy:     /s/ Marianne De Backer
Name:     Jeff PoultonName:     Marianne De Backer, Ph.D., B.Sc., MBA
Title:    CFOTitle:    CEO
Date:     March 7, 2025Date:     March 6, 2025
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SCHEDULE A
ALNYLAM IN-LICENSES AND EXISTING ALNYLAM THIRD PARTY AGREEMENTS
[***]


SCHEDULE A-1
CERTAIN EXISTING ALNYLAM IN-LICENSES
[***]


SCHEDULE B
ALN- HBV AND ALN-HBV02
[***]


SCHEDULE C-1
ALNYLAM CORE TECHNOLOGY PATENT RIGHTS
[***]


SCHEDULE C-2
ALNYLAM PRODUCT-SPECIFIC PATENT RIGHTS
[***]



SCHEDULE D
ALNYLAM DISCLOSURE SCHEDULE
[***]

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