Authority in such country or jurisdiction, including by referencing or relying on Regulatory Approvals (or Data therein) of such Licensed Product or Vir Program Product.
1.AK“共享獨佔” means, with respect to the license granted by Sanofi pursuant to Section 2.1.3 (Co-Exclusive License to Vir Program Co-Exclusive Compounds and the Vir Program Co-Exclusive Products), that Vir, its Affiliates, and its Sublicensees shall be the only Persons who may practice the Licensed IP to Exploit a Co-Exclusive Compound or Co-Exclusive Product arising from use of the Amunix Platform in the Territory in the Platform License Field other than: (a) Sanofi and its Affiliates and their respective
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subcontractors in connection with Exploiting Co-Exclusive Compounds and Co-Exclusive Products, (b) any Third Party or its subcontractors in connection with a collaboration, partnership, or joint-venture transaction with Sanofi or its Affiliates for the purpose of Exploiting such Co-Exclusive Compounds or Co-Exclusive Products, and (c) subject to Section 2.12 (Vir First Right of Negotiation), any Third Party (or its subcontractors) to which Sanofi or its Affiliates licenses or otherwise transfers Exploitation rights for any such Co-Exclusive Compound or Co-Exclusive Product in any country or territory after Sanofi and its Affiliates has discontinued or has decided to discontinue all or substantially all Research, Development, and Commercialization activities with respect to such Co-Exclusive Compound or Co-Exclusive Product in such country or territory (such license or other transfer referenced in this clause (c), a “Co-Exclusive ROFN Transaction”).
1.AL“Co-Exclusive Compound” means any compound that (a) includes at least one Co-Exclusive Platform Component, and (b) does not include a Licensed XTEN.
1.AM“Co-Exclusive Platform Component” means (i) a Protease-Cleavable Linker that is at least [***] amino acids long, (ii) a Barcode, (iii) an anti-EGFR Binding Domain having an amino acid sequence that is identical to the amino acid sequence of the anti-EGFR Binding Domain in AMX-525, (iv) an anti-PSMA Binding Domain created by or on behalf of Sanofi prior to the Acquisition Date, or (v) an anti-CD3 Binding Domain having an amino acid sequence that is identical to the amino acid sequence of the anti-CD3 Binding Domain in a Named Compound.
1.AN“Co-Exclusive Product” means any pharmaceutical preparation containing a Co-Exclusive Compound alone or in combination with one or more additional active ingredients.
1.AX“Compound Blocking IP「」指有效日期或涵蓋期間由賽諾菲或其關聯公司控制的任何專利,不包括已許可專利,涵蓋(i)已命名化合物的組成;(ii)賽諾菲在有效日期使用的含有該已命名化合物的已許可產品的組成或配方;(iii)賽諾菲在有效日期用於生產已命名化合物或含有該已命名化合物的已許可產品的實際臨床供應的製造方法;(iv)賽諾菲在有效日期使用的已命名化合物使用方法;或(v)賽諾菲在有效日期使用的用於研究已命名化合物或含有該已命名化合物的已許可產品的研究工具。 ,爲抑鬱症、焦慮症和其他沉思性障礙提供了有前景的新療法。 used by Sanofi as of the Effective Date; or (v) a Research Tool used by Sanofi as of the Effective Date to Research a Named Compound or a Licensed Product containing such Named Compound.
polypeptide chain of such Named Compound and, in each case ((a) and (b)), containing the same number of XTENs as such Named Compound.
1.BE“Derived Patent” means any Patent filed by or on behalf of Vir, its Affiliates, or its or their Sublicensees after the Effective Date but before the First Commercial Sale of the first Licensed Product or Vir Program Product, the claims of which are supported by any Licensed Know-How, excluding (i) Patents directed to any compound or uses thereof arising from the Exploitation by or on behalf of Sanofi, its Affiliates, or licensees of the Amunix Platform other than a Licensed Compound and (ii) with respect to Licensed Know-How created after the Acquisition Date, Patents directed to the production, manufacture, processing, formulating (excluding pharmaceutical formulations for ,爲抑鬱症、焦慮症和其他沉思性障礙提供了有前景的新療法。 administration), filling, finishing, packaging, labeling, shipping, holding, manufacture process development, stability testing, quality assurance, or quality control of a compound or product or any intermediate thereof.
1.BN“生效日期。” means (a) if a determination is made pursuant to Section 13.2 (Filings) that no HSR/Antitrust Filing is required to be made under any Antitrust Law for this Agreement, the date that is three (3) Business Days after the date of such determination; and (b) if a determination is made pursuant to Section 13.2 (Filings) that an HSR/Antitrust Filing is required to be made under any Antitrust Law for this Agreement, date that is three (3) Business Days after the Antitrust Clearance Date.
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1.BO“Equipment Bill of Sale” means that certain bill of sale with respect to the Purchased Equipment attached hereto as Exhibit 1.67 (Equipment Bill of Sale).
1.BU“執行日期” has the meaning set forth in the preamble hereto.
1.BV“高管” means a senior executive of a Party having corporate authority to make decisions regarding this Agreement.
1.BW“利用” means Research, Develop, Manufacture, perform medical affairs activities for, Commercialize, or otherwise use or exploit. 「Exploitation」 will be construed accordingly.
1.CI“HSR法案” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. § 18a).
1.CJ“HSR/Antitrust Filing” means: (a) a filing by Vir and a filing by Sanofi with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act), together with all required documentary attachments thereto; or (b) any comparable filing by Vir or Sanofi required under any other Antitrust Law, in each case ((a) or (b)), with respect to the transactions contemplated by this Agreement.
1.CK“IND” means an investigational new drug application (including any addition, extension, modification, amendment, or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312. References herein to IND will include, to the extent applicable, any non-US counterpart of the foregoing filed with a Regulatory Authority for the investigation of a product in any country or group of countries (such as a Clinical Trial Application in the EU) outside the U.S. in conformance with the requirements of such Regulatory Authority.
1.CL“賠償請求通知「」指11.3節(索賠通知)中規定的含義。
1.CM“受保護方” 指11.3節(索賠通知)中規定的含義。
1.CN“賠償方「」在第11.3節(索賠通知)中的含義。
1.公司“傳染病領域”指所有(a)治療、預防、減輕和診斷用途,以 (i) 使用特異性結合到病原體的化合物減少或阻止病原體的傳播、殺傷病原體或以其他方式抑制病原體的複製,或 (ii) 使用特異性結合到毒素的化合物抑制病原體產生的毒素,以及/或 (b) 用於治療活躍病原體感染的治療用途,通過向患有活躍病原體感染的患者施用一種將患者的免疫系統引導到減少或阻止病原體的傳播、殺傷病原體或以其他方式抑制病原體複製的化合物,但排除主要獲益和目標不是清除活躍病原體感染的應用程序,在(a)和(b)的情況下,其中病原體是病毒、原核生物、原生動物、朊病毒或真菌。爲明確起見,傳染病領域不包括(x)所有被動和主動免疫用途和 (y) 所有與免疫學相關的用途,除了(b)。
1.CS“已開具銷售發票” has the meaning set forth in Section 1.127 (Net Sales)
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1.CT“Joint Platform Improvement IP” means any intellectual property developed or invented jointly by or on behalf of the Parties between the Effective Date and [***] that is directed to Protease-Cleavable Linkers having improvements and modifications that have been made in whole or in part using experiments in which such Protease-Cleavable Linkers were conjugated to Licensed XTENs.
1.CU“知識產權” means non-public technical or scientific information, including Data, amino acid sequences, nucleotide sequences, chemical structures, chemical sequences, formulas, methods, processes, procedures, practices, protocols, techniques, discoveries, inventions (whether patentable or not), specifications, designs, trade secrets, and supply chain sources, as well as any of the foregoing included or referenced in Regulatory Documentation.
1.DK“製造” 和 “製造業-半導體” means, with respect to a product, all activities related to the production, manufacture, processing, formulating, filling, finishing, packaging, labeling, shipping, holding, manufacture process development, stability testing, quality assurance, or quality control of such product or any intermediate thereof.
1.DL“Manufacturing Documentation” means, with respect to any Licensed Materials, the certificates of analysis and similar documentation in Sanofi’s possession and Control, as agreed to by the Parties in the Transition Plan.
1.DX“非XTEN Activatable t Cell Engager Technology” [***].
1.DY“受邀員工” means each individual listed on Schedule 1.130 to whom an offer of employment is or was made by Vir.
1.DZ“Oncology Field” means all therapeutic, prophylactic, palliative, and diagnostic uses to treat any indication characterized by malignant cellular proliferation, including solid or liquid malignancies (including primary and metastatic tumors), and lymphoid and myeloid neoplasms.
1. EE“專利” means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed from any of the foregoing provisional patent applications in clause (a), (c) all patent applications that claim priority to any patent or patent applications in clause (a) or clause (b), including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (d) any and all patents that have issued or in the future issue from any of foregoing patent applications in clause (a), clause (b) or clause (c), including utility models, petty patents and design patents and certificates of invention, and (e) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of any of the foregoing patents or patent applications in clause (a), clause (b), clause (c) or clause (d).
1.EF“付款” has the meaning set forth in Section 6.8 (Taxes).
1.EG“Pending Review Know-How” means the Know-How set forth in Schedule 1.138.
1.FM“專利權期限” means for each of the Licensed Products and the Vir Program Products, on a product-by-product and country-by-country basis, the period commencing upon First Commercial Sale of a Licensed Product or Vir Program Product in a country until the latest of (a) twelve (12) years after the First Commercial Sale of such Licensed Product or Vir Program Product in such country, (b) the expiration of the last to expire Valid Claim of a Patent within the Licensed Patents or Derived Patents that Covers such Licensed Product or Vir Program Product in such country, and (c) expiration of any Regulatory Exclusivity for such Licensed Product or Vir Program Product in such country.
1.GS“Vir計劃共享獨佔產品” means any pharmaceutical preparation containing a Vir Program Co-Exclusive Compound, alone or in combination with one or more additional active ingredients.
1.GT“Vir Program Compound” means each Vir Program XTEN Compound, Vir Program Co-Exclusive Compound, or Vir Program Other Compound.
1.GU“Vir Program Know-How” means any Know-How first Controlled by Vir after the Effective Date (for clarity, excluding Licensed Know-How) that constitutes an improvement to any Licensed Platform Patents or Licensed Know-How directed to the Amunix Platform.
conduct a [***]. Upon conclusion of the audit, the independent auditor will issue a determination to both Parties indicating whether Vir has breached Section 2.6.3(i) (Exclusion Period Restrictions). Sanofi shall cause such auditor to enter into a confidentiality agreement with the Parties that includes an obligation of such auditor to retain all information it receives during such audit in confidence.
(iii)Effects of Auditor’s Determination. In the event that the auditor determines Vir has not breached Section 2.6.3(i) (Exclusion Period Restrictions), the auditor shall not disclose any information it receives during such audit to Sanofi. In the event that the auditor determines Vir has breached Section 2.6.3(i) (Exclusion Period Restrictions), [***].
(iv)成本. The cost of any such audit shall be borne by Sanofi, unless the auditor determines Vir has breached Section 2.6.3(i) (Exclusion Period Restrictions), in which case Vir shall reimburse Sanofi for the documented out-of-pocket costs incurred by Sanofi in such audit within [***] of receipt of Sanofi’s corresponding invoice.
2.GRetention of Rights除Vir根據第2.1節(授予Vir的許可)獲得的許可外,作爲雙方之間,Sanofi保留對許可知識產權的所有權利、所有權和利益。 [***].
以Territory爲界限,Vir將獨立控制及擁有決策權,關於(a)利用自身費用在Territory內開發此類Licensed Product在Compound License Field中的利用的Licensed Compounds和Licensed Products;以及(b)Vir將依自身費用爲Platform License Field中的Vir Program Product開發Vir Program Compounds和Vir Program Products。
4.B製造合規。 Vir應確保自身及其關聯方、再許可方和第三方分包商嚴格遵守適用法律,以保證以符合要求的方式製造Licensed Compounds、Licensed Products、Vir Program Compounds和Vir Program Products。
6.A預付款項。 作爲在此授予的權利和許可的部分考慮,在生效日期,Vir應支付一次性預付款如下:(i)一億美元($100,000,000),按照Sanofi在生效日期之前提供給Vir的電匯指示的要求轉賬給Sanofi。Sanofi預付款”) and (ii) Seventy Five million Dollars ($75,000,000) payable to the escrow account established pursuant to the Escrow Agreement, by wire transfer of immediately available funds, which amount shall be held and distributed in accordance with Section 6.2.1 (Escrow Mechanics) and the Escrow Agreement (“Escrowed Payment,” and together with the Sanofi Upfront Payment, the “預付款”). [***].
6.BEscrow Mechanics; Other Merger Agreement Milestone Payments.
6.B.1Escrow Mechanics. In the event that [***], Sanofi and Vir will, on or promptly after the Effective Date, issue to the Escrow Agent a Joint Written Instruction (as such term is defined in the Escrow Agreement) to release the Escrowed Payment to Sanofi. In the event that [***]賽諾菲和威爾將立即向託管代理發出聯合書面指示(如託管協議中所定義),根據併購協議要求,將託管支付釋放給付款代理(如併購協議中所定義)。如果 [***]賽諾菲和威爾將立即向託管代理發出聯合書面指示(如託管協議中所定義),根據威爾提供的電匯指示,將託管支付釋放給威爾。
6.C.1Development and Regulatory Milestones. Vir shall notify Sanofi of achievement by Vir, its Affiliates or Sublicensees of the development and regulatory milestone events described in the table below (each a “Development and Regulatory Milestone Event”) within [***] after the corresponding Development and Regulatory Milestone Event is achieved. Upon such achievement of a Development and Regulatory Milestone Event, Vir shall pay Sanofi the non-refundable, non-creditable development and regulatory milestone payment described in the table below for the applicable Development and Regulatory Milestone Event (each a “Development and Regulatory Milestone Payment”) within [***] after Vir’s receipt of an invoice with respect to such achievement of a Development and Regulatory Milestone Event. Each Development and Regulatory Milestone Payment shall be payable only upon the first achievement of such Development and Regulatory Milestone Event for Licensed Product containing the applicable Named Compound
Licensed Products containing AMX-525 or Derivative Compound
Licensed Products containing AMX-912 or Derivative Compound
Each Vir Program Product
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[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
6.D.2Payment Dates and Reports. During the Royalty Term, Vir shall deliver to Sanofi a detailed royalty payment report within [***] after the end of each Calendar Quarter which shall include: (a) the Net Sales of the Licensed Products and Vir Program Products by country in the Territory; (b) the applicable royalty rates for the Licensed Products and Vir Program Products; (c) the exchange rates used in calculating any of the foregoing; and (d) a calculation of the amount of royalty due to Sanofi. Vir shall pay all royalties due in any Calendar Quarter within [***] after receipt of an invoice therefor from Sanofi, which invoice Sanofi shall provide to Vir following Sanofi’s receipt of the applicable royalty payment report, commencing with the Calendar Quarter in which the first day of the first Royalty Term for the first Licensed Product or first and Vir Program Product occurs.
6.IInterest Rate for Late Payment. Any payment under this Agreement that is not paid on or before the date such payment is due will bear interest, to the extent permitted by Applicable Law, at [***] above the rate for deposits in Dollars for a period of three-months as published by the Federal Funds Effective Rate (or any successor to such rate); measured at 14:00 GMt on the date payment is due, as reported by the Federal Reserve of New York (for example via https://apps.newyorkfed.org/markets/autorates/fed%20funds). Interest shall be calculated on the number of days such payment is overdue, compounded annually and computed on the basis of a three hundred and sixty-five (365)-day year.
6.J財務記錄. Vir shall, and shall require its Affiliates and Sublicensees to, keep complete and accurate books and records pertaining to the sale of the Licensed Products, including books and records of Invoiced Sales, the calculation of Net Sales of the Licensed Products and Vir Program Products in the
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Territory (including the deductions taken to derive Net Sales) and complete copies of each Sublicense Agreement. Vir shall, and shall require its Affiliates and Sublicensees to, retain such books and records and other information referred to in the preceding sentence that are relevant to determine compliance with this Agreement, until the latest of (a) three (3) years after the end of the period to which such books and records (and other information) pertain, (b) the expiration of the applicable tax statute of limitations (or any extensions thereof), or (c) for such period which is longer than either (a) or (b) as may be required by Applicable Law.
6.K審計. At the request of Sanofi, Vir shall, and shall require its Affiliates and Sublicensees to, permit an independent certified public accountant retained by Sanofi and reasonably acceptable to Vir, at reasonable times during regular business hours and upon at least [***] 書面通知,以審計根據第6.10條(財務記錄)維護的賬簿、記錄和其他信息,僅評估Vir是否遵守本協議的條款和條件。此類審計不得(a)在任何一個財政季度之後進行 [***] 一個財政季度結束之後,(b)進行多於 [***],或者(c) [***]。獨立的註冊會計師應當同時向雙方出具報告,闡明本協議項下任何支付是否存在差錯(如果存在,差錯金額及任何超額支付或不足支付的金額),以及該會計師是如何得出此結論的合理信息。除非下文規定,任何審計的成本應由Sanofi承擔,除非審計發現對所審計期間的報告金額存在不足支付超過 [***] ,在這種情況下,Vir應在收到Sanofi對此類審計實際支出費用的發票後 [***] 內償還Sanofi。除非根據第6.12條(審計爭議)進行爭議處理,(i)如果會計師在其報告中得出結論認爲Vir未按時支付應付款項,Vir應在收到Sanofi相應發票後,支付此類金額及利息 [***] ,此發票的日期不得早於會計師將其審計報告交付各方的日期;(ii)如果會計師在其報告中得出結論認爲Vir多付了任何本協議項下應付款項,Vir可以將此類金額抵充未來支付(或者如果根據本協議Sanofi不再有進一步支付,則Sanofi應向Vir返還此類超額付款),在 [***] 收到Vir相應發票後,此發票的日期不得早於會計師將其審計報告交付各方的日期。根據Vir的要求,所指定的會計師應簽署一份協議,內容應得到雙方合理接受,以保護向該會計師提供的信息的保密性,以及保護該會計師的調查結果和報告的保密性。
7.B.2許可產品專利根據第7.2.3節(最低訴訟和維護義務),Vir應有第一權,但非義務,以其自費、自選由Sanofi合理接受的律師控制,準備、申請、進行訴訟和維護,包括任何干擾、再授權程序、複審、專利期延長、補充保護證書申請及反對(作動詞時)領域內所有許可產品專利的處理。雙方應誠信合作,完成將許可產品專利的訴訟轉移給Vir或其指定法律顧問,需要在生效日期前合理提前每次提交前(不少於審查”和“起訴” 作動詞時 [***] 之前。在每次遞交前合理提前(不少於 [***], Vir will provide Sanofi with a reasonable opportunity to review and comment on the proposed submission to any patent office and to provide input on Prosecution strategy, which Vir will consider in good faith. Vir will keep Sanofi reasonably informed of the status of the applicable Patents by timely providing Sanofi with copies of any papers and all material communications relating to such Patents that are received from any patent office or patent counsel of record or foreign associate. In the event that Vir desires to abandon or cease Prosecution of any Licensed Product Patents in the Territory, Vir shall provide reasonable prior written notice to Sanofi of such intention to abandon at least [***] in advance of the due date of any payment or other action that is required to
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Prosecute such Licensed Product Patent and Sanofi shall thereafter have the sole right, but not the obligation, to Prosecute such Licensed Product Patent, at its sole cost and expense and by counsel of its own choice. Further, if Vir decides to close prosecution of a Licensed Product Patent family in any country or jurisdiction (such as before the European Patent Office) by not filing a subsequent divisional or continuation application before a grant of a Licensed Product Patent in that country or jurisdiction, Vir shall provide reasonable prior written notice to Sanofi of such intention to not file a subsequent divisional or continuation application at least [***] in advance of the deadline and seek Sanofi’s written consent, which will not be unreasonably withheld or conditioned, and which consent shall be deemed to have been granted if Sanofi does not respond within [***] following receipt of such notice from Vir. Sanofi shall have the sole right, but not the obligation, to Prosecute such divisional or continuation in such country or jurisdiction, at its sole cost and expense and by counsel of its own choice.
7.B.3Minimum Prosecution Obligations. Notwithstanding Section 7.2.2 (Licensed Product Patents), Vir shall, unless Sanofi has exercised its step-in right to Prosecute a Licensed Product Patent pursuant to Section 7.2.2 (Licensed Product Patents), Prosecute, and shall not abandon or cease Prosecuting, the Licensed Product Patents in the countries and regions set forth on Schedule 7.2.3 (Minimum Prosecution Countries and Regions) (including that Vir shall comply with the obligations specified therein for Prosecution via the European Patent Organisation), [***].
7.B.4Licensed Platform Patents.
(i)Licensed Amunix Sub-Platform Patents. Vir shall have the first right, but not the obligation, to control the Prosecution of all Licensed Amunix Sub-Platform Patents at its sole cost and expense and by counsel of its choosing that is reasonably acceptable to Sanofi. The Parties shall cooperate in good faith to complete the transfer of Prosecution of Licensed Amunix Sub-Platform Patents to Vir or its designated legal counsel within [***] of the Effective Date. Reasonably in advance of each substantive submission to be filed (and no less than [***], Vir will provide Sanofi with a reasonable opportunity to review and comment on the proposed submission to any patent office and to provide input on Prosecution strategy, which Vir will consider in good faith. Vir will keep Sanofi reasonably informed of the status of the applicable Patents by timely providing Sanofi with copies of any papers and all material communications relating to such Patents that are received from any patent office or patent counsel of record or foreign associate. In the event that Vir desires to abandon or cease Prosecution of any such Licensed Amunix Sub-Platform Patent, Vir shall provide reasonable prior written notice to Sanofi of such intention to abandon at least [***] in advance of the due date of any payment or other action that is required to Prosecute such Licensed Amunix Sub-Platform Patent and Sanofi shall thereafter have the sole right, but not the obligation, to prosecute and maintain such Licensed Amunix Sub-Platform Patent, at its sole cost and expense and by counsel of its own choice. Further, if Vir decides to close prosecution of a Licensed Amunix Sub-Platform Patent family in any country or jurisdiction (such as before the European Patent Office) by not filing a subsequent divisional or continuation application before a grant of a Licensed Amunix Sub-Platform Patent in that country or jurisdiction, Vir shall provide reasonable prior written notice to Sanofi of such intention to not file a subsequent divisional or continuation application at least [***] 在最後期限之前並尋求零售凱素的書面同意,該同意不得被不合理地拒絕或附加條件,並且如果零售凱素在收到來自Vir的通知後不回覆[***],則應視爲已授予同意。零售凱素應有單獨的權利,但非義務,以其自行選擇的代理律師以其單獨的費用和支出在相應國家或管轄區立案或續展。
7.C.1侵權索賠通知。 如果任何一方發現(a)在平台許可領域涉及任何已許可專利、平台改進知識產權、派生專利或Vir計劃專利的任何懷疑侵權情況,(b)根據BPCIA提起的任何程序聲稱任何已許可專利、平台改進知識產權、派生專利或Vir計劃專利無效或不可執行,或聲稱根據BPCIA提起的程序對於在平台許可領域內生產、使用、銷售或進口相應產品的專利、平台改進知識產權、派生專利或Vir計劃專利不會構成侵權,或在任何其他轄區根據該領域發起的等效或類似程序,或(c)任何第三方聲稱,無論是作爲辯護、索賠或作爲反訴的內容,以在平台許可領域內進行的任何活動有關方面提起的申訴,聲稱任何已許可專利、平台改進知識產權、派生專利或Vir計劃專利無效或不可執行,以上每一款(a)、(b)和(c)均稱爲“侵權”), or would not be infringed, such Party shall promptly notify the other Party and provide it with all details of such Infringement of which it is aware (each, an “Infringement Notice”).
7.C.2Licensed Product Patents and Licensed Amunix Sub-Platform Patents. With respect to any Infringement, Vir shall have the first right, but not the obligation, through counsel of its choosing that is reasonably acceptable to Sanofi, to control enforcement of (a) Licensed Product Patents and (b) the Licensed Amunix Sub-Platform Patents against such Infringement at Vir’s sole cost and expense, or to grant the infringing Third Party adequate rights and licenses necessary for continuing such activities in accordance with Section 7.3.6; provided that Vir shall keep Sanofi informed reasonably in advance of all material steps to be taken in the preparation and conduct of such enforcement and shall furnish Sanofi with copies of all pleadings and other documents filed with the court, and all material documents and communications exchanged with the infringing Third Party, and shall consider reasonable input from Sanofi during the course of the conduct of such
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enforcement. If Vir does not (a) initiate such enforcement (where 「initiate」 includes making contact with the infringing Third Party) within [***] of learning of such Infringement and (b) diligently pursue such enforcement, including (if appropriate, consistent with such diligent pursuit of enforcement) filing an action within [***] before the time limit, if any, set forth in the Applicable Laws governing the filing of an enforcement action (subject to extension of such period by mutual agreement of the Parties, not to be unreasonably withheld, conditioned or delayed), or earlier notifies Sanofi in writing of its intent not to so initiate or diligently pursue enforcement, and Vir has not granted such infringing Third Party rights and licenses to continue its otherwise infringing activities, then Sanofi shall have the right, but not the obligation, to control such enforcement at Sanofi’s sole cost and expense.
Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except in connection with exercising its rights and performing its obligations under this Agreement. “保密信息” means any information provided by or on behalf of one Party or its Affiliates (the “披露方”) to the other Party or its Affiliates (the “Receiving Party”) under or in connection with this Agreement, including the terms of this Agreement or any information relating to the Licensed Products, any information relating to any Exploitation of the Licensed Products or Vir Program Products in the Territory, or the scientific, regulatory or business affairs or other activities of either Party or its Affiliates. The terms of this Agreement and any Know-How included within the Joint Platform Improvement IP will be deemed the Confidential Information of both Parties, with each Party as a Receiving Party. The Licensed Know-How (other than Licensed Know-How that is solely related to a Named Compound as set forth below) and the Know-How within the Sanofi Platform Improvement IP will be treated as the Confidential Information of Sanofi, with Vir as the Receiving Party, for the purposes of this Agreement. From and after the Effective Date, the Vir Program Know-How, Vir Platform Improvement IP, the reports and records delivered by or on behalf of Vir under Section 3.2.2 (Reports) and Section 3.4 (Records), and Licensed Know-How that is solely related to the Named Compounds will be treated as the Confidential Information of Vir, with Sanofi as the Receiving Party, for the purposes of this Agreement. Notwithstanding the foregoing, Confidential Information shall not include any information that:
9.A.1is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act or omission on the part of the Receiving Party;
10.C.1不得停工無論 Vir 或其關聯公司,或在過渡計劃履行期間與此協議項下的活動有關的 Sanofi 或其關聯公司,均不得使用在本協議項下執行的活動中已被暫停、被建議停工或被列入 21 U.S.C. §335a 停工名單或被聯邦醫療保健計劃(如 42 U.S.C. Sec. 1320 a-7b(f) 中定義)制裁的任何個人,其中包括但不限於聯邦醫療保險或州醫療補助計劃,或被聯邦機構或計劃停工、暫停、排除或以其他方式被宣佈不合格。 該方應及時以書面形式通知對方,如果在此處執行活動的任何個人或其本人被停工、暫停、排除、制裁或以其他方式被宣佈不合格,或者收到有關任何此類停工、暫停、排除、制裁或不合格的行動或威脅的通知。
10.DSanofi的契約.
10.D.1在生效日期之前。
(i)從簽署日期至生效日期, 除非(1)本協議另有規定,(2)根據適用法律或簽署日期存有的並向 Vir 披露的任何合同所要求,(3)爲完成本協議所涉交易所採取的任何由 Sanofi 進行的行動,或(4)經 Vir 書面同意,該同意不得被不合理地拒絕、附加條件或延遲,Sanofi 不得,也應確保其關聯公司不得:
(a)銷售、轉讓、過戶或以其他方式處置(除授權的任何有關已在附表 1.111(已許可專利產品專利)、附表 1.102(已許可的Amunix 子平台專利)、或附表 1.103(已許可的Amunix XTEN 平台專利)中被確定爲關閉的任何許可知識產權)許可知識產權中的任何部分,除非與根據第14.4條款(轉讓)允許的轉讓相關,授予任何可能與生效日期前已授予 Vir 的排他許可和共同獨佔許可權衝突的許可權。
10.F額外豁免。 VIR HEREBY ACKNOWLEDGES AND AGREES THAT: (A) EXCEPt FOR THE BREACH OF SECTION 10.2 (REPRESENTATIONS AND WARRANTIES OF SANOFI), SANOFI WILL HAVE NO LIABILITY TO VIR FOR ANY ACt OR OMISSION IN THE PREPARATION, FILING, PROSECUTION, MAINTENANCE, ENFORCEMENt, DEFENCE OR OTHER HANDLING OF THE LICENSED PATENTS; (B) VIR IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED PATENTS HAVE APPLICABILITY OR UTILITY IN VIR’S CONTEMPLATED EXPLOITATION OF LICENSED PRODUCTS, AND VIR ASSUMES ALL RISk AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION; (C) SANOFI MAKES NO REPRESENTATION OR WARRANTY AS TO THE COMPLETENESS OF THE LICENSED KNOW-HOW; (D) VIR IS SOLELY RESPONSIBLE FOR DETERMINING WHETHER THE LICENSED KNOW-HOW HAS APPLICABILITY OR UTILITY IN VIR’S CONTEMPLATED EXPLOITATION OF LICENSED PRODUCTS, AND VIR ASSUMES ALL RISk AND LIABILITY IN CONNECTION WITH SUCH DETERMINATION.
11.AIndemnification of Sanofi. Vir shall indemnify Sanofi, its Affiliates and its and their respective directors, officers, employees, and agents (collectively, “Sanofi Indemnitees”), and defend and hold each of them harmless, from and against [***].
11.BIndemnification of Vir. Sanofi應當對Vir及其附屬機構以及各自的董事、高管、員工和代理人(統稱爲「Vir」)進行賠償,並保護他們免受任何和所有與第三方索賠有關的損失。Vir 受賠償人,並對所有由此產生或引起的第三方索賠的任何和所有損失提出訴訟並使其免受損害。
11.C索賠通知。 所有關於Sanofi受益方或Vir受益方的賠償請求應僅由Sanofi或Vir提出,視情況而定(Sanofi或Vir中的每一個在此能力下,爲“被賠償方 方”; and the Party owing the indemnification obligation under this Agreement, the “賠償方”). The Indemnified Party shall give the Indemnifying Party prompt written notice (an “賠償 開空 提供姓名全稱、身份證號或公司註冊號、地址、白天的電話號碼以及代表、代理人和助手的信息。 助手的數量不得超過兩個。爲便於進入年度股東大會,通知應在適當的情況下附有授權書、註冊證書和其他授權文件。”) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Section 11.1 (Indemnification of Sanofi), or Section 11.2 (Indemnification of Vir), but in no event shall the Indemnifying Party be liable for any Losses that result from any delay in providing such notice other than in the event such delay materially prejudices the Indemnifying Party’s ability to defend the applicable claim. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such
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time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.
12.B因重大違約而終止本協議。 如果任何一方嚴重違反本協議(該方爲“違約方”),此外,對於違約的一方(“Complaining Party”) may have, the Complaining Party may terminate this Agreement in its entirety upon [***] prior written notice (the “Termination Notice Period”) to the Breaching Party, specifying the material breach and its claim of right to terminate; provided however that (a) the termination shall not become effective at the end of the Termination Notice Period if the Breaching Party cures the material breach complained of during the Termination Notice Period, except in the case of a payment breach, as to which the Breaching Party shall have only a [***] cure period; (b) if such breach is not reasonably capable of cure within the Termination Notice Period, the Breaching Party may submit a cure plan reasonably acceptable to the Complaining Party prior to the end of the Termination Notice Period, in which case the Termination Notice Period shall be extended for so long as the Breaching Party is using reasonable efforts to implement such cure plan; and (c) if the Breaching Party disputes in good faith (i) whether it has materially breached this Agreement, (ii) whether such material breach is reasonably curable within the cure period, (iii) whether it has cured such material breach within the cure period, or (iv) whether the relevant breach primarily relates to one or more (but not all) Licensed Products or Vir Program Products, then (y) the dispute will be resolved pursuant to Section 14.6 (Dispute Resolution) and, during the pendency of such dispute resolution procedure, this Agreement may not be
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terminated and the Parties shall continue to perform all of their respective obligations that are not in dispute, and (z) the Complaining Party shall not have the right to terminate this Agreement under this Section 12.2 (Termination of this Agreement for Material Breach) unless and until (1) a final decision under Section 14.6 (Dispute Resolution) determines that such breach exists and such breach then remains uncured and (2) such Breaching Party fails to cure such breach within [***] (or, with respect to a payment breach, [***] following such decision. Notwithstanding the foregoing, if the material breach and failure to cure contemplated by this Section 12.2 (Termination of this Agreement for Material Breach) is with respect to Vir’s Development diligence obligations under Section 3.2.2 (Developmental Diligence) or Vir’s Commercialization diligence obligations under Section 5.2 (Commercialization Diligence), with respect to any Licensed Product or Vir Program Product, but not all Licensed Products or Vir Program Products, as applicable, Sanofi shall not have the right to terminate this Agreement in its entirety, but shall have the right to terminate this Agreement solely with respect to the applicable Licensed Product or Vir Program Product unless one or more other Licensed Products have previously been terminated pursuant to this Section 12.2 (Material Breach), in which case, Sanofi may terminate this Agreement and with respect to all Licensed Products upon having the right to terminate this Agreement with respect to a second Licensed Product.
13.B申報儘快在執行日期之後(但不遲於【***】之後的執行日期,除非經各方書面同意),Vir和Sanofi將準備並提交給美國聯邦貿易委員會(聯邦貿易委員會”) and the Antitrust Division of the United States Department of Justice (the “司法部”) any HSR/Antitrust Filing required of it under the HSR Act and, as soon as practicable, file with the appropriate Governmental Authority any other HSR/Antitrust Filing required of it under any other Antitrust Law as determined in the reasonable opinion of either Party with respect to the transactions contemplated by this Agreement. The Parties will cooperate with one another to the extent necessary in the preparation of any such HSR/Antitrust Filing. Each Party will be responsible for its own costs and expenses associated with any HSR/Antitrust Filing; provided, however, that the Parties will share equally all fees (other than penalties that may be incurred as a result of actions or omissions on the part of a Party, which penalties will be the sole financial responsibility of such Party) required to be paid to any Governmental Authority in connection with making any such HSR/Antitrust Filing. In the event that the Parties make an HSR/Antitrust Filing under this Section 13.2 (Filings) and such HSR/Antitrust Filing has not been approved by the applicable Governmental Authority, this Agreement may terminate at the election of either Party, immediately upon notice to the other Party, upon the occurrence of the Outside Date. Notwithstanding any provision to the contrary in this Agreement, except for the terms and conditions of this Article 13 (Government Approvals), none of the terms and conditions contained in this Agreement will be effective until the Effective Date.
13.CInformation Exchange. Each of Vir and Sanofi will, in connection with any HSR/Antitrust Filing: (a) reasonably cooperate with each other in connection with any communication, filing or submission and in connection with any investigation or other inquiry, including any proceeding initiated by a private party; (b) keep the other Party or its counsel informed of any communication received by such Party from, or given by such Party to, the FTC, the DOJ or any other U.S. or other Governmental Authority and of any communication received or given in connection with any proceeding by a private party, in each case, regarding the transactions contemplated by this Agreement; (c) consult with each other in advance of any meeting or conference with the FTC, the DOJ or any other Governmental Authority or, in connection with any proceeding by a private party, with any other Person, and to the extent permitted by the FTC, the DOJ or such other Governmental Authority or other Person, give the Parties or their counsel the opportunity to attend and participate in such meetings and conferences; and (d) to the extent practicable, permit the other Party or its counsel to review in advance any submission, filing, or communication (and documents submitted therewith) intended to be given by it to the FTC, the DOJ or any other Governmental Authority; 在每種情況下,該B類股東和/或該B類股東的家庭成員需獨立控制在此類帳戶、計劃或信託中持有的B類普通股實時; 材料可能會被編輯刪除披露方業務估值或其他敏感信息的參考,披露方在判斷時認爲需要。Vir和Sanofi各自視爲必要和明智,可以合理指定任何有競爭敏感性的材料,以便在本第13條下提供給對方。