この研究協力およびライセンス契約(以下「本契約」といいます。合意)は2024年9月28日(以下「効力発生日」といいます。有効日)と、Bristol-Myers Squibb社の完全子会社であり、事業所を[***]に置くデラウェア州法人であるJuno Therapeutics, Inc.(以下「貴社」といいます。BMS)と、マサチューセッツ州ケンブリッジ市ファースト・ストリート60番地に事業所を置くデラウェア州法人であるPrime Medicine, Inc.(以下「当社」といいます。プライム”). BMS and Prime are referred to individually as a “当事者当事者当事者”.
前文
以下の通り, Prime has proprietary technologies for the development and production of Prime Reagents (as defined below);
1.27“バイオシミラール製品” means, with respect to a Licensed Product, on a country-by-country basis, a biologic product (a) whose licensing, approval, or marketing authorization relies in whole or in part on (i) a Regulatory Approval granted for such Licensed Product or (ii) any data generated in support of a Regulatory Approval granted for such Licensed Product or (b) that is determined by the applicable Regulatory Authority in or for such country to be biosimilar to or interchangeable with such Licensed Product, including as set forth at 42 USC §262(k) in the United States or other Applicable Law. For purposes of Section 6.5.3(b), a Licensed Product distributed by or on behalf of BMS, its Affiliates or Sublicensees as a “biosimilar” (例えば, without use of the applicable Product Trademarks) under the same Regulatory Approval as a Licensed Product (つまり, an authorized biosimilar) will not constitute a Biosimilar Product, except for any such “biosimilar” sold on behalf of BMS by a
2
Third Party to which BMS grants authorized biosimilar rights to settle or avoid litigation related to (x) the alleged infringement by a Licensed Reagent or Licensed Product or the Exploitation thereof of any Patents or other intellectual property of a Third Party or (y) the alleged non-infringement, invalidity, or unenforceability of any Patents claiming a Licensed Reagent or Licensed Product or Exploitation thereof.
1.28“BMS” has the meaning set forth in the preamble of this Agreement.
1.53“Chief Executive Officer” means each period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall begin on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.55“支配権変更” means, with respect to a Party, any of the following, in a single transaction or a series of related transactions: (a) the sale, lease, exchange, contribution, or other transfer to a Third Party of all or substantially all of the assets of such Party (or, if applicable, any Affiliate(s) controlling such Party) to which this Agreement relates; (b) the direct or indirect acquisition by a Third Party of beneficial ownership of more than fifty percent (50%) of the then-outstanding securities or other voting interests of such Party (or, if applicable, any Affiliate(s) controlling such Party) unless such securities or other voting interests is acquired (i) by an employee benefit plan (or related trust) sponsored or maintained by such Party or any of its Affiliates or (ii) in a transaction or series of related transactions the primary purpose of which is a 善意の equity financing of such Party, excluding any equity financing that results in a Life Sciences Entity Controlling such Party (or, if applicable, any Affiliate(s) controlling such Party); or (c) the merger, reorganization, consolidation, or business combination involving such Party (or, if applicable, any Affiliate(s) controlling such Party) with a Third Party that results in the holders of the beneficial ownership of the voting securities or other voting interests of such Party (or, if applicable, any Affiliate(s) controlling such Party) immediately prior to such merger, reorganization, consolidation, or business combination
1.99“First European Target Product「” has the meaning set forth in Section 6.4.2.」
1.100“First Milestone Sale「” means, with respect to a Licensed Product, an Indication, and a country, [***]. For clarity, [***] shall not constitute a First Milestone Sale.」
1.101“First US Target Product「」は第6.4.2項に規定されている意味を持ちます。
1.116“適応症” means, with respect to a Licensed Product, a separate and distinct disease or medical condition for which a separate Registrational Trial is required for Regulatory Approval and is reflected in the “Indications and Usage” section of labeling pursuant to 21 C.F.R. §201.57(c)(2) or, to the extent applicable, any comparable labeling section outside the U.S.; 提供 that: (a) different symptom domains or domains of impairment of the same disease or condition are not additional Indications for such Licensed Product; (b) the approved use of such Licensed Product for a disease in different combinations or co-therapies of treatments are not additional Indications for such Licensed Product (例えば, monotherapy vs. add-on or combination therapy with another agent in the same disease); (c) treatment, prevention, and cure of the same disease or disease subtype with such Licensed Product are not additional Indications for such Licensed Product; (d) the approved use of such Licensed Product for such disease in a different line of treatment or a different temporal position in a treatment algorithm for the same disease or condition are not additional Indications for such Licensed Product (e.g., first line vs. second line therapy in the same disease or condition); and (e) treatment of the same disease or condition with such Licensed Product in an expanded, modified or additional patient population are not additional Indications for such Licensed Product.
1.163“当事者”または“当事者” has the meaning set forth in the preamble of this Agreement.
1.164“PASSIGE Reagent” means [***].
1.165“特許” means: (a) all patents and patent applications, including provisional patent applications; (b) all patent applications filed from or claiming priority to such patents or patent applications, including divisionals, continuations, continuations-in-part, converted provisionals, and continued prosecution applications; (c) all patent applications claiming priority to the same application as the foregoing patents and patent applications in (a) or (b); (d) all patents that have issued or in the future issue from the foregoing patent applications in (a), (b), and (c), including utility models, petty patents and design patents and certificates of invention; (e) all extensions or
11
restorations by existing or future extension or restoration mechanisms, including adjustments, revalidations, reissues, re-examinations, and extensions (including any patent term restorations/extensions, supplementary protection certificates and the like) of the foregoing patents or patent applications in (a), (b), (c), and (d); and (f) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patents of addition to any of such foregoing patent applications and patents, and any equivalents of the foregoing.
2.2.4決定JSCは、コーラムが存在する会議に出席する代表者の合意によって行動を採ります。各当事者は、出席した当事者の数に関係なく1つの投票権を有します。または、各当事者が任命した代表者によって署名された書面決議によって行動を採ることもあります。JSCが問題について合意に達しない場合、または達しない場合、その紛争は解決されます。そのような最終的な意思決定が書面でなければならない場合があります。[***]; except that (a)[***] and (b) the following disputes shall [***].
For clarity, the JSC shall have no right to resolve Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith and that are outside of the jurisdiction of the JSC, which shall be resolved pursuant to Section 12.8.
2.2.5Working Groups. From time to time, the JSC may establish working groups (each, a “Working Group”), and shall establish the Patent Working Group and the Safety Working Group pursuant to Section 8.2.1 and Section 5.6.4(a), respectively, to oversee particular projects or activities within the scope of the JSC’s responsibilities, and each such Working Group shall be constituted and shall operate as the JSC determines; provided 各作業班には各当事者からの代表が配置されること。 さらに、前述の第(i)項から第(iii)項に係るものについては、過去3年間に作成または取得された文書に限り提供されます。各当事者の代表者間での紛争は、セクション2.2.4および本契約のその他の条件に従ってJSCに提出され、解決されること。作業班は、特定のプロジェクトのためにアドホックな基準で、JSCの任期中、またはJSCが決定するその他の基準で設立される場合がある。各作業班およびその活動は、JSCの監督を受け、JSCに報告しなければならない。いかなる場合でも、作業班の権限はJSCに指定された権限を超えてはならない。
3.5研究計画. 初期の研究計画はここに添付されています スケジュール3.5. The desirable attributes and other required criteria for each Prime Reagent (the “受け入れ基準”) shall be set forth in the Research Plan. The Research Plan shall reflect activities aimed at Researching Prime Reagents that satisfy the Acceptance Criteria. [***] Without limiting the foregoing, the JSC shall review the Research Plan annually for the purpose of considering appropriate amendments thereto, and either Party may propose amendments to the Research Plan at any time by submitting such proposed amendment in writing to the JSC for review and approval.
3.6Conduct of the Research Plan.
3.6.1取り組み. With respect to each Selected Reagent Target, Prime will identify, generate and further Research Prime Reagents with respect thereto in accordance with the applicable Reagent Characteristics and as further set forth in the Research Plan and will use [***] to Develop Prime Reagents for such Selected Reagent Target that achieve the applicable Acceptance Criteria. Prime shall commit sufficient staffing, equipment, facilities, materials, and other resources to timely perform all the activities allocated to it under the Research Plan.
3.6.2Compliance; Oversight. During the Research Term, Prime shall conduct Research in accordance with the Research Plan and Applicable Law and in good scientific manner and consistent with good business ethics and data integrity, subject to the oversight, direction, and supervision of the JSC, including that [***].
3.6.3サブコントラクティング. Prime [***].
3.6.42023年第4四半期において、MPLXの総費用および費用は16億ドルからわずかに減少しています。総費用および費用の減少は、営業費用(仕入品の費用を含む)の低下に帰することができます。. Except as otherwise provided in this Agreement, including Section 6.6, or the Research Plan or as otherwise mutually agreed by the Parties in writing, Prime shall be solely responsible for its costs and expenses for the conduct of the Research Plan. For the avoidance of doubt, subject to Section 6.6.1, BMS agrees to reimburse Prime for costs and expenses for the conduct of any activities in the Research Plan that are labeled as requiring reimbursement by BMS.
3.6.5Additional Optimization Activities. With respect to each Prime Editing Reagent for each Other Reagent Target, [***].
21
3.7Delivery of Prime Reagents; Acceptance.
3.7.1Notice of Prime Reagentsリサーチ期間中、各選択された試薬ターゲットに関して、Primeは、そのリサーチの過程で該当選択された試薬ターゲットの適用受入基準を満たすとPrimeが判断するものを生成した際、速やかにBMSに通知し、該当するAcceptance Criteriaを満たすとPrimeが判断したPrime試薬の説明およびそのPrime試薬が適用受入基準を満たすという判断を支持する一切の結果をJSCに速やかに提出する。
(a)if [***] (such date, with respect to [***] the “Acceptance Date。
(b)if [***].
3.8資材の移転.
3.8.1Prior to any (a) supply to BMS of any [***]Transferred Prime Materials or other materials to conduct the BMS Evaluation Activities pursuant to Section 3.7.2 [***] the Parties shall enter into a material transfer agreement, in the form attached hereto as Schedule 3.8, pursuant to which Prime shall supply to BMS, or BMS shall supply to Prime, as applicable, the applicable materials in accordance with the terms and conditions of this Agreement and as set forth in the Research Plan, as applicable.
6.4.3売上段階マイルストーン. Subject to the terms and conditions of this Agreement (including the last sentence of Section 6.5.2, Section 6.10, Section 11.7(b), and Section 11.8.1), with respect to each milestone event set forth in the table immediately below (each, a “売上マイルストーンイベント”), on a Licensed Product-by-Licensed Product basis, BMS shall pay Prime a non-creditable, non-refundable payment of the corresponding milestone payment set forth in such table (each, a “売上マイルストーン支払い”) within [***] after the end of the Calendar Year in which BMS or any of its Affiliates or its or their Sublicensees first achieves such Sales Milestone Event for such Licensed Product.
#
Sales Milestone Event
Sales Milestone Payment
1.
[***]
[***]
2.
[***]
[***]
3.
[***]
[***]
4.
[***]
[***]
5.
[***]
[***]
If in a given Calendar Year (a) more than [***] Sales Milestone Event is achieved for a particular Licensed Product, BMS shall pay Prime a separate Sales Milestone Payment with respect to each Sales Milestone Event that is achieved by such Licensed Product in such Calendar Year or (b) the same Sales Milestone Event is achieved by more than one (1) Licensed Product, BMS shall pay Prime a separate Sales Milestone Payment with respect to each
6.9遅滞金. Any amount (or portion thereof) required to be paid by a Party hereunder that is not paid within [***] of the date such amount is due will accrue interest at an annual rate of [***] above the prime rate as published by Citibank, N.A., New York, New York, or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue (or the maximum legal interest rate allowed by Applicable Law, if less) from and after such date, calculated based on the number of days such payment is late, and the late Party will be responsible for reasonable legal fees and expenses incurred by the other Party in connection with the collection thereof.
6.10Right to Offset. Each Party shall have the right to offset any amount owed by the other Party to such first Party under or in connection with this Agreement against any payments owed by such first Party to such other Party under this Agreement. Such offsets shall be in addition to any other rights or remedies available under this Agreement and Applicable Law.
6.11財務記録. (a) BMS shall, and shall cause its Affiliates to, keep complete and accurate financial books and records pertaining to Net Sales and (b) Prime shall, and shall cause its Affiliates to, keep complete and accurate financial books and records pertaining to Optimization Costs for Additional Optimization Activities, in each case ((a) and (b)), to the extent required to calculate and verify all amounts payable hereunder. Each Party shall, and shall cause its Affiliates to, retain such books and records until the later of (x) [***] after the
34
end of the period to which such books and records pertain and (y) the expiration of the applicable tax statute of limitations (or any extensions thereof) or for such longer period as may be required by Applicable Law.
6.12 .
6.12.1At the request of the other Party, each Party shall, and shall cause its Affiliates (and in the case of BMS, shall use commercially reasonable efforts to cause its and their Sublicensees) to, permit an independent public accounting firm of nationally recognized standing designated by the other Party and reasonably acceptable to the audited Party (or its Affiliate or, in the case of BMS, its or its Affiliate’s Sublicensee, as applicable), at reasonable times during normal business hours and upon reasonable notice, to audit the books and records maintained pursuant to Section 6.11 to ensure the accuracy of all reports and payments made hereunder. Such audits may not (a) be conducted for any Calendar Quarter more than [***] after the end of such Calendar Quarter, (b) be conducted more than once in any [***], or (c) be repeated for any Calendar Quarter. The accounting firm shall disclose only whether the reports are correct or not, and the specific details concerning any discrepancies. No other information shall be shared. The cost of each audit shall be borne by the auditing Party unless an audit reveals a variance of more than the greater of [***] from the reported amounts and [***], in which case the audited Party shall bear the cost of such audit. Unless disputed pursuant to Section 6.12.2, if such audit concludes that (x) additional amounts were owed by one Party to the other Party, the owing Party shall pay the additional amounts (and, if such additional amounts are owed due to an error in an invoice or report provided by such owing Party, with interest thereon as provided in Section 6.9) or (y) excess payments were made by one Party to the other Party, the overpaid Party shall reimburse such excess payments (and, if such excess payments were made due to an error in an invoice or report provided by such overpaid Party, with interest thereon as provided in Section 6.9), in either case ((x) or (y)), within [***] after the date on which such audit is completed by the auditing Party.
6.12.2In the event of a dispute with respect to any audit under Section 6.12.1, Prime and BMS shall work in good faith to resolve such dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [***], the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party’s certified public accountants or to such other Person as the Parties shall mutually agree (the “Audit Expert”). The decision of the Audit Expert shall be final and the costs of such resolution as well as the initial audit shall be borne between the Parties in such manner as the Audit Expert shall determine. If such decision concludes that (a) additional amounts were owed by one Party to the other Party, the owing Party shall pay the additional amounts (and, if such additional amounts are owed due to an error in an invoice or report provided by such owing Party, with interest thereon as provided in Section 6.9) or (b) excess payments were made by one Party to the other Party, the overpaid Party shall reimburse such excess payments (and, if such excess payments were made due to an error in an invoice or report provided by such overpaid Party, with interest thereon as provided in Section 6.9), in either case ((a) or (b)), within [***] after such decision and in accordance with such decision.
6.13機密保持. The Receiving Party shall treat all information subject to review under this Article 6 in accordance with the confidentiality provisions of Article 7, and the Parties shall cause the accounting firm or the Audit Expert, as applicable, to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such accounting firm or Audit Expert, as applicable, to retain all such financial information in confidence pursuant to such confidentiality agreement.
6.14税金.
6.14.1当社の取締役および幹部は、2020年プランの修正と改訂に関するこの提案に関心を持つと見なされる可能性があります。そうした取締役および幹部は、2020年プランの下での受賞資格があります。. The receiving Party will pay any and all taxes levied on account of all payments it receives under this Agreement. The paying Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law. The paying Party shall: (a) deduct those taxes from such payment; (b) timely remit the taxes to the proper taxing authority; and (c) send evidence of the obligation, together with proof of tax payment, to the receiving Party on a timely basis following that tax payment. Notwithstanding the foregoing sentence, if the paying Party takes any action of its own discretion that is not required by the terms of this Agreement or a Regulatory Authority, including any assignment, sublicense, change of place of incorporation, or failure to comply with Applicable Laws or filing or record retention requirements, and such action results in an additional or increased
7.1“機密情報”とは、 Companyの事業、または実際のまたは明らかに予想される研究または開発に関連する、すべての機密的な知識、データ、または情報を意味します。
. “機密情報” means any technical, business, or other information provided by or on behalf of one Party or any of its Affiliates (the “情報開示側”) to the other Party or any of its Affiliates (the “受領側”) in connection with this Agreement, whether prior to, on or after the Effective Date, including: the terms of this Agreement (subject to Section 7.6); Know-How relating to the Selected Reagent Targets, Licensed Reagents, Product Targets, or Licensed Products; any Development, Manufacturing, or Commercialization of any Licensed Product; or the scientific, regulatory, or business affairs or other activities of either Party. Notwithstanding the foregoing, [***] Confidential Information constituting the terms of this Agreement and any other Joint Know-How shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the Receiving Party and the Disclosing Party with respect thereto).
7.2Nondisclosure and Non-Use Obligation. Subject to Section 7.3, at all times during the Term and for a period of [***] after termination or expiration of this Agreement in its entirety, and thereafter with respect to any Confidential Information that either Party specifically identifies to the other Party in writing that constitutes a trade secret under Applicable Law, for so long as such Confidential Information constitutes a trade secret under Applicable Law, each Party shall, and shall cause its Affiliates, its and their Sublicensees, and its and their
36
Distributors, officers, directors, employees, contractors, and agents (“代表者この契約の条件によって明示的に許可されている場合を除き、秘密情報を第三者に漏洩したり、公開したり、その他の方法で利用してはならず、また、他の当事者の機密情報を直接または間接的にいかなる目的でも使用してはならない。
8.1.1概要第8.1.2条に基づいて、(a) Primeは、本契約の下で単独でまたはPrimeまたはその関連会社によって開発されたすべてのノウハウ、特許およびその他の知的財産権について、全ての権利、所有権、および利益を所有し続けることができます。 Know-How、特許およびその他の知的財産権について(c)各当事者は、本契約の下で、BMS材料/ターゲットノウハウまたはPrimeプラットフォーム改善ノウハウ以外の未分割の権利、所有権、および利益全ての同等かつ不可分の権利を保有し続けることができます。知識が共同で考案され、発見され、開発され、またはその他作成された場合、一方においてはBMSまたはその関連会社、「他方の当事者」であるPrimeまたはその関連会社によって。本契約に基づいて共同ノウハウ”) and any and all Patents other than BMS Materials/Target Patents or Prime Platform Improvement Patents (“Joint Patents”), and other intellectual property rights with respect to the Joint Know-How other than BMS Materials/Target IP or Prime Platform Improvement IP (collectively, together with the Joint Know-How and Joint Patents, “共同知的財産”). Each Party shall promptly disclose to the other Party in writing and shall cause its Affiliates to so disclose, the discovery, generation, creation, or conception of any Joint IP. Subject to the licenses granted under Section 4.1, each Party’s confidentiality obligations under Article 7, and, in the case of Prime, its exclusivity obligations under Section 4.6, each Party shall have the right to Exploit the Joint IP without a duty of seeking consent or accounting to the other Party. For clarity, for the purpose of Article 8, neither Party or its Affiliates, or its or their (sub)licensees/Sublicensees, shall be considered a (sub)licensee (or, with respect to BMS, a Sublicensee) of the other Party or its Affiliates.
8.1.2Exceptions.
(a)BMS Materials/Target IP. Notwithstanding Section 8.1.1, subject to the license grants and other rights herein, as between the Parties, BMS shall exclusively own all right, title, and interest in and to any and all BMS Materials/Target IP, regardless of which Party or any of its Affiliates or (sub)licensees/Sublicensees conceived, discovered, developed, or otherwise made such BMS Materials/Target IP or whether such BMS Materials/Target IP was jointly conceived, discovered, developed, or otherwise made by or on behalf of the Parties or their Affiliates or (sub)licensees/Sublicensees. Prime shall, and does hereby assign, and shall cause its Affiliates and (sub)licensees to so assign, all right, title, and interest in any and all BMS Materials/Target IP, including all BMS Target IP, to BMS. For clarity, with respect to a Select BMS Proprietary Reagent Target, the foregoing assignment shall only apply with respect to the Select BMS Use, not to the general application of such Select BMS Proprietary Reagent Target.
(i)合意8.4.2(d)に従い、当事者間で、PrimeはReagent Specific PatentsではないPrime特許のDefendおよびEnforce、および(A)Product Infringementに関するものを除くReagent Specific PatentsのDefendおよびEnforce、各場合において(A)と(B)を、独自の費用と負担、自ら選択した法律顧問を使用して行う権利を有します。
(ii)当事者間で、BMSはReagent Specific Patentsに関するProduct Infringementに対するDefendおよびEnforceの先行権を有しますが、その義務はありません。
9.2.4有効日時点で存在するすべての主要特許(以下総称して、「既存特許」が列挙されています スケジュール9.2.4, Part A(以下総称して、「所有特許」)または Part B(以下総称して、「In-Licensed Patents”). All Owned Patents and, to Prime’s Knowledge, all In-Licensed Patents, are subsisting. To Prime’s Knowledge, no Existing Patent is invalid or unenforceable, in whole or in part. All Owned Patents are solely and exclusively owned by Prime or its Affiliates, free of any encumbrance, lien, or claim of ownership by any Third Party. All In-Licensed Patents are solely and exclusively in-licensed by Prime or its Affiliates in accordance with the terms of the applicable Existing In-License Agreements and, to Prime’s Knowledge, are free of any encumbrance in the Field, lien in the Field, or claim of ownership by any Third Party (other than the counterparty to the applicable Existing In-License Agreement or co-owner(s)). All Owned Patents and, to Prime’s Knowledge, all In-Licensed Patents have been filed and maintained properly and correctly and all applicable fees have been paid on or before any final due date for payment. The pending applications included in the Owned Patents and, to Prime’s Knowledge, the In-
46
Licensed Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law. With respect to each pending application in the Owned Patents, Prime and its Affiliates have presented all relevant references, documents and information of which it and the inventors are aware to the relevant patent offices. With respect to each pending application in the In-Licensed Patents, to Prime’s Knowledge, all relevant references, documents, and information of which Prime or the counterparty to the applicable Existing In-License Agreement and the inventors are aware have been presented to the relevant patent office;
9.2.5Prime has provided to BMS complete and correct copies of all material documents and files from the image file wrappers, as that term is understood under Applicable Law in the United States, solely to the extent that such image file wrappers are not publicly available, for the Owned Patents and, to the extent in Prime’s or any of its Affiliates’ possession, the In-Licensed Patents and all such materials are true, complete, and correct;
10.1BMSによる賠償BMSは、Prime、その関連会社、およびそれぞれの取締役、役員、従業員、代理人(以下「Prime保証者)を、合理的な弁護士費用および経費を含むすべての損失、損害、責任、罰金、費用、および費用(以下、「損失」)に関連するすべての訴訟、調査、請求、または第三者の要求(以下、「第三者請求”) arising from or occurring as a result of:
(a)the breach by BMS of this Agreement;
(b)the Exploitation of a Licensed Product by or on behalf of BMS or any of its Affiliates, its or their Sublicensees, or its or their Distributors in the Territory; or
(c)the gross negligence or willful misconduct on the part of any BMS Indemnitee under this Agreement;
except, in each case ((a) – (c)), to the extent such Losses arise from or occur as a result of (x) any matter described in Section 10.2 (whether or not the applicable Third Party Claim was incurred by any BMS Indemnitee) for which Prime would have an obligation to indemnify any BMS Indemnitee or (y) the negligence on the part of any Prime Indemnitee under this Agreement, in either case ((x) or (y)), as to which Losses each Party shall indemnify the BMS Indemnitees or Prime Indemnitees, as applicable, to the extent of its respective liability for such Losses.
10.2Indemnification by Prime. Prime shall indemnify BMS, its Affiliates, its and their Sublicensees and Distributors and its and their respective directors, officers, employees, and agents (the “BMS Indemnitees”) and defend and hold each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims arising from or occurring as a result of:
(a)the breach by Prime of this Agreement;
(b)the performance by or on behalf of Prime of its activities under the Research Plan or Manufacturing under this Agreement;
(c)[***]; or
(d)the gross negligence or willful misconduct on the part of any Prime Indemnitee under this Agreement;
except, in each case ((a) – (d)), to the extent such Losses arise from or occur as a result of (x) any matter described in Section 10.1(a) or Section 10.1(c) (whether or not the applicable Third Party Claim was incurred
51
by any Prime Indemnitee) for which BMS would have an obligation to indemnify any Prime Indemnitee or (y) the negligence on the part of any BMS Indemnitee under this Agreement, in either case ((x) or (y)), as to which Losses each Party shall indemnify the BMS Indemnitees or Prime Indemnitees, as applicable, to the extent of its respective liability for such Losses.
11.1Term and Expiration. The term of this Agreement (the “期間”) shall commence on the Effective Date and, unless terminated earlier pursuant to this Article 11, shall continue in force and effect on a Licensed Product-by-Licensed Product and country-by-country basis until the date of expiration of the last Royalty Term for the applicable Licensed Product in the applicable country. After the expiration of the Royalty Term for a Licensed Product in a country, the grants in Section 4.1 shall become fully-paid, royalty-free, perpetual, and irrevocable for such Licensed Product in such country. For clarity, upon the expiration of the Term, the grants in Section 4.1 shall become fully-paid, royalty-free, perpetual, and irrevocable in their entirety.
11.2都合による終了. BMS may, in its sole discretion, terminate (a) this Agreement in its entirety at any time during the Term or (b) this Agreement on a country-by-country or Product Target-by-Product Target basis, in each case ((a) and (b)), without cause, by giving Prime [***] prior written notice.
11.3違反による解除.
11.3.1両当事者(以下「違反当事者」)のいずれかがこの契約の重要な義務のいずれかを実質的に違反した場合、他の当事者(以下「非違反当事者」)が持つその他の権利および救済の追加に加えて、傀儡党は[***] (以下、「通知期間」)この事前書面による通知(以下「終了通知”) to the Breaching Party and specifying the breach and its claim of right to terminate; provided that (a) subject to Section 4.6.2(e) and Section 4.6.3(e), the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the breach specified in the Termination Notice during the Notice Period (or, with respect to curable breaches other than the breach of an undisputed payment obligation, if such breach cannot be cured within the Notice Period, if the Breaching Party commences actions to cure such breach within the Notice Period and, thereafter diligently continues such actions), (b) with respect to any alleged breach by BMS of its diligence obligations set forth in Section 5.3, Prime shall first provide written notice thereof to BMS and the Parties shall meet within [***] after delivery of such notice to BMS to discuss in good faith such alleged breach, which [***] must expire before Prime may issue any Termination Notice with respect to such alleged breach (for clarity, the Notice Period shall not commence prior to the conclusion of such [***] and the subsequent issuance of a Termination Notice by Prime), and (c) if the Breaching Party initiates a dispute resolution procedure under Section 12.8 during the Notice Period to dispute the existence of the breach for which termination is being sought, or whether such breach has been cured, and is pursuing such procedure in good faith, the cure period set forth in this Section 11.3.1 shall be tolled and the termination shall become effective only if the final resolution of the dispute through such dispute resolution procedure determines that the Breaching Party is in material breach of one (1) or more of its material obligations under this Agreement and such breach remains uncured for [***] after such determination; provided that if the breach cannot be cured within such [***] the termination shall not become effective at the end of such [***] if the Breaching Party commences actions to cure such breach within such [***] and thereafter diligently continues such actions.
11.5倒産に対する終了当事者のいずれか(または該当する場合、その当事者の親)が破産事由イベントを経験した場合、他方の当事者は、その第一当事者に書面で即座に通知することにより、直ちにこの契約を全面的に終了することができます。 provided that in the case of any involuntary bankruptcy proceeding, such right to terminate will only become effective if the Party (or, if applicable, the parent of such Party) consents to the involuntary bankruptcy or such proceeding is not dismissed within [***] after the filing thereof.
11.6終了の結果.
11.6.1一般的に. In the event of termination of this Agreement with respect to one (1) or more Product Targets (each, a “Terminated Target”) or one (1) or more country(ies) (each, a “Terminated Territory本契約に別段の定めがない限り(セクション11.8に規定された存続規定を含む)、本契約に基づく当事者の権利および義務、セクション4.1のBMSへのライセンス付与(終了対象又は終了領域に関して)(セクション4.1.2に基づいて付与されたサブライセンスを含む)、は、その終了日をもって、該当終了対象又は終了領域に関して終了します。 提供された ただし、本契約が1つ以上の終了対象又は1つ以上の終了領域に対して終了されるが、全領域に対しては終了されない場合、本契約に基づくBMSへの権利とライセンスは、終了対象又は終了領域に関して非独占となり、終了領域において終了対象に向けられたライセンス製品の開発および製造の権利のみを含み、終了対象に向けられたライセンス製品の規制承認又は商業化を支援するためにのみ、存続する国々において終了対象に向けられたライセンス製品を製造します。
11.6.2在庫本契約が(全体として又はいかなる終了対象又は終了領域に関しても)終了された場合、BMS(又はその関連会社又はそのサブライセンシー)が、その終了対象の終了日時点で使用可能なライセンス製品の在庫を有している場合、BMS(およびその関連会社及びそのサブライセンシー)は、そのライセンス製品をその国々において使用目的に応じて販売し続けることができます(そして顧客の注文に応じてそのための製造を含み、終了日の前に行われた顧客注文のために当該ライセンス製品を製造することができます)(a)終了日の[***]後又は(b)BMS(又はその関連会社又はそのサブライセンシー)がそのようなライセンス製品の在庫を保有していなくなる日の早い方まで。 提供された BMSは、第6.5項に基づくその販売に基づく Prime に支払われるべきロイヤルティを支払うものとする。
12.7適用法本契約およびその履行、強制、違反、または終了は、米国ニューヨーク州の法律に従って解釈され、管理され、および解釈されるものとし、本契約の解釈もしくは構築を他の管轄権の担当法に他のいかなる法律の解決法も参照しないことを除く 提供 that (a) all questions concerning inventorship and ownership of Patents under this Agreement shall be determined in accordance with Section 8.1 and (b) all questions concerning the construction or effect of Patents shall be determined in accordance with the laws of the country or other jurisdiction in which the particular Patent has been filed or granted, as the case may be. The Parties agree to exclude the application of the United Nations Convention on Contracts for the International Sale of Goods to this Agreement.
58
12.8紛争解決.
12.8.1紛争. Except for disputes resolved by the procedures set forth in Section 2.2.4 or Section 6.12.2, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “紛争”), it shall be resolved pursuant to this Section 12.8. Any Dispute shall first be referred to the Senior Executives of the Parties, who shall confer in good faith on the resolution of the issue. Any final decision mutually agreed to by the Senior Executives in writing shall be conclusive and binding on the Parties. If the Senior Executives are not able to agree on the resolution of any such issue within [***] (or such other period of time as mutually agreed by the Senior Executives) after such issue was first referred to them, then, except as otherwise set forth in Section 12.8.2, either Party may, by written notice to the other Party, elect to initiate an alternative dispute resolution (“ADRは、2023年12月31日までの年間において、前年度の2022年12月31日までの124ドルに対し、5.6%増の131ドルに上昇しました。”) proceeding pursuant to the procedures set forth in Section 12.8.3 for purposes of having the matter settled.
12.10英語の言語. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into
59
any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
12.11公正な救済. Each Party acknowledges and agrees that the restrictions and obligations set forth in Section 4.6, Article 7, and Article 8 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Section or Articles shall result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Section or Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits, and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Each Party hereby waives any requirement that the other Party (a) post a bond or other security as a condition for obtaining any such relief or (b) show irreparable harm, balancing of harms, consideration of the public interest, or inadequacy of monetary damages as a remedy. Nothing in this Section 12.11 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
12.12免責および救済措置の除外. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. Except as set forth in Section 11.7, the rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.