Provision Language
<p><em><strong>Definitionsstrong>em>p>
<p>“<b>Dynavax Manufacturing Informationb>” <span style=”font–weight: 400;”>means information or documentation in the possession or under the control of Dynavax relating to the development or manufacture of the Dynavax Adjuvant, that, in each case: (a) is contained in any Dynavax <a href=”#kt“>Regulatory Filinga> that Dynavax authorizes Customer or any <a href=”#kt“>Regulatory Authoritya> to reference or use in connection with Customer or any of its affiliates, Licensees or Authorized Third Party, applying for, obtaining or maintaining Regulatory Approval for any Customer Product; or (b) is submitted by or on behalf of Dynavax to any Regulatory Authority for use or reference in connection with Customer or any of its affiliates, their Licensees or any Authorized Third Party, applying for, obtaining or maintaining <a href=”#kt“>Regulatory Approvala> for any Customer Product; or (c) is disclosed or provided by or on behalf of Dynavax to Customer or any of its affiliates for submission to any Regulatory Authority in connection with Customer or any of its affiliates, or their Licensees or any Authorized Third Party, applying for, obtaining or maintaining Regulatory Approval for any Customer Product. Without limiting the generality of the foregoing, Dynavax Manufacturing Information includes the Specifications. In addition, the identity and concentration tests for Dynavax Adjuvant to transferred to Customer pursuant to Section 3.8 shall constitute Dynavax Manufacturing Information.span>p>
<p>“<b>Remaining Stockb>” <span style=”font–weight: 400;”>means any Dynavax Adjuvant supplied by Dynavax to Customer or any of its affiliates pursuant to the Supply Agreement that (a) remain in the possession or control of Customer or any of its affiliates or their Licensees (including any such Dynavax Adjuvant in the physical possession of a third party contractor that is being held on behalf of Customer, its affiliate or a Licensee) as of the expiry or termination of the Supply Agreement or (b) are delivered by Dynavax to Customer or any of its affiliates after the expiry or termination of this Agreement in accordance with Section 15.span>p>
<p><span style=”text–decoration: underline;”><strong>3. <b>Supply of Dynavax Adjuvant b>strong>span>p>
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<p><span style=”font–weight: 400;”><strong>3.6strong> Customer hereby covenants on behalf of itself and its affiliated entities not to, and not to permit or cause any of its affiliated entities, any of its permitted manufacturers or distributors, or any other third party to, directly or indirectly: (a) except as permitted by Section 3.7, modify or create derivatives from the Dynavax Adjuvant or attempt to reverse engineer, deconstruct or in any way determine the structure or composition of the Dynavax Adjuvant; (b) use the Dynavax Adjuvant for any product other than the Customer Product(s); (c) use the Dynavax Adjuvant to develop, use or seek regulatory approval for the Dynavax Adjuvant except for the Dynavax Adjuvant as incorporated in Customer Product(s); (d) sell, resell, transfer, convey, dispose of, or otherwise provide access to the Dynavax Adjuvant except (i) for transfer of the Dynavax Adjuvant to Licensees and Customer’s or its affiliate’s or their Licensees’ contract research organization / contract manufacturer of Customer Product(s) for the sole purpose of developing / manufacturing Customer Product(s) on behalf of Customer or any of its affiliates or their Licensees, or (ii) as incorporated in Customer Product(s); or (e) use the Dynavax Adjuvant for any purpose other than the research, development, manufacture, use, sale, offer for sale, importation, export or other commercialization of Customer Vaccine or Customer Product(s). span>p>
<p><span style=”font–weight: 400;”><strong>3.7strong> Customer, its affiliates or their Licensees, or third party contractors acting on behalf of any of them, may (i) perform identity test(s) and to test the concentration of Dynavax Adjuvant in the Dynavax Adjuvant supplied hereunder, and (ii) use Dynavax’s tests for identity and concentration for the purpose set out in (i) above, and Customer, its affiliates and their Licensees may develop/have developed, manufacture/have manufactured, sell, and have sold on their behalf, Customer Product(s) including Dynavax Adjuvant (whether formulated with the Customer Vaccine in the same vial or separately in an accompanying vial).span>p>
<p><span style=”text–decoration: underline;”><b>5. Intellectual Propertyb>span>p>
<p><strong>5.1 strong><span style=”font–weight: 400;”>Customer acknowledges that the Dynavax Adjuvant is proprietary to Dynavax, that Dynavax shall at all times remain the sole and exclusive owner of all <a href=”#kt“>Intellectual Property Rightsa> in and to the Dynavax Adjuvant, and that Customer shall not obtain any right, ownership interest, or, except as expressly set forth in the Supply Agreement, license, in or to such Intellectual Property Rights in the Dynavax Adjuvant as a result of its purchase, receipt or use of the Dynavax Adjuvant. Customer shall not file (or cause to be filed) any patent application claiming or disclosing any Dynavax Manufacturing Information disclosed or made available to Customer hereunder. span>p>
<p><span style=”font–weight: 400;”><strong>5.2strong> Subject to the terms and conditions of the Supply Agreement, Dynavax hereby grants to Customer during the Term, and, with respect to any Remaining Stock, for so long after expiry or termination of the Supply Agreement as such Remaining Stock remains in the possession or control of Customer or its affiliate or their Licensees (including any such Remaining Stock in the physical possession of a third party contractor that is being held on behalf of Customer, its affiliate or a Licensee), a limited non exclusive, non transferable (except as otherwise expressly set forth in the Supply Agreement), royalty–free (except to the extent expressly set forth in Section 6.4) license, which Customer, in its sole discretion, may extend to its affiliates, under Dynavax’s Intellectual Property Rights in and to the Dynavax Adjuvant, solely to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import, export or otherwise commercialize span><span style=”font–weight: 400;”>Customer Product(s); span><i><span style=”font–weight: 400;”>provided, however, span>i><span style=”font–weight: 400;”>that the license to make and have made Customer Product(s) is limited to the right to make or have made Customer Product(s) using the Dynavax Adjuvant supplied by Dynavax pursuant to the Supply Agreement, and [***]. The license granted to Customer under this Section 5.2, including as extended by Customer to its affiliates, includes the right to sublicense solely to: (i) Customer’s or any of its affiliates’ Licensees span><i><span style=”font–weight: 400;”>provided that span>i><span style=”font–weight: 400;”>any such Licensee that will develop and/or make Customer Product(s) shall first have entered into a written sublicense agreement with Customer or its affiliate obligating such Licensee to be bound by all applicable provisions of this Agreement. However, (a) Customer or its affiliate(s) or their Licensees may contract with third party contract manufacturers for the manufacture on behalf of Customer or its affiliate(s) or their Licensees, as applicable, of Customer Product(s) using the Dynavax Adjuvant supplied hereunder, (b) Customer or its affiliate(s) or their Licensees may contract with third party contract research organizations for the development on behalf of Customer or its affiliate(s) or their Licensees, as applicable, of Customer Product(s) using the Dynavax Adjuvant supplied hereunder, (c) Customer or its affiliate(s) or their Licensees may contract with third parties including distributors, wholesalers, retailers, GPOs, and purchasing organizations (such as COVAX, GAVI) for warehousing, distribution and/or sale whether independently or on behalf of Customer or its affiliate(s) or their Licensees, as applicable, of Customer Product(s), and (d) Customer or its affiliate(s) may contract with any third party for that third party to apply for, obtain, update and maintain Regulatory Approval(s) for the Customer Product(s) on behalf of Customer and/or its affiliate, or on such third party’s own behalf if it is also a Licensee, in each case, in accordance with Section 10.5, and such contracting in each case (clauses (a), (b), (c) and (d)) shall not be considered a sublicense. The foregoing license shall not be construed to obligate Dynavax to disclose or transfer to Customer any such Intellectual Property Rights [***]. Customer shall be responsible and liable for the compliance of its affiliates, their Licensees, and third party contractors with the terms and conditions of this Agreement. span>p>
<p><strong>5.3strong><span style=”font–weight: 400;”> Dynavax acknowledges that (a) the Customer Vaccine and Customer Product(s) (excluding the Dynavax Adjuvant incorporated or included in or with Customer Product(s), which is proprietary to Dynavax) are proprietary to Customer, and that Customer shall at all times remain the sole and exclusive owner of all Intellectual Property Rights in and to the Customer Vaccine and Customer Product(s) (excluding the Dynavax Adjuvant incorporated or included in or with Customer Product(s), which is proprietary to Dynavax), and (b) any other rights including Intellectual Property Rights in and to the Customer Vaccine and Customer Product(s) (excluding the Dynavax Adjuvant incorporated or included in or with Customer Product(s), which is proprietary to Dynavax) (i) owned or controlled by Customer, its affiliates and their licensor(s) and Licensee(s) as of the Effective Date, or (ii) created, licensed or otherwise acquired independently of this Supply Agreement by Customer, its affiliates and their licensor(s) and Licensee(s) shall remain their respective, sole and absolute property, and that Dynavax shall not obtain any right or ownership interest thereto. For clarity, nothing in the Supply Agreement, including this Section 5.3 is intended to or will be construed to imply that Dynavax Adjuvant is proprietary to Customer. span>p>
<p><span style=”font–weight: 400;”><strong>5.4strong> The Parties hereby agree that all rights to any invention, whether or not patentable, that is generated by or on behalf of Customer in the course of using any of the Dynavax Adjuvant supplied hereunder or developing, using, manufacturing or having manufactured Customer Product(s), that, in each case, [***] shall be [***] and [***]. span>p>
<p><span style=”font–weight: 400;”>The Parties hereby agree that [***]. The Parties agree that [***]. span>p>
<p><strong>5.5 strong><span style=”font–weight: 400;”>Dynavax and Customer shall [***]. The Parties agree that [***]. Customer hereby grants Dynavax (a) [***], and (b) [***]. Dynavax hereby grants Customer (a) [***]; and (b) [***]. . span>p>
<p><span style=”font–weight: 400;”><strong>5.6strong> In the event a [***]Invention is created by a Party, such Party shall notify the other Party without delay including provision of details of such [***]Invention. [***]. span>p>
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<p><span style=”font–weight: 400;”><strong>5.8strong> No right or license under any Intellectual Property Rights of a Party is granted or shall be granted to the other Party by implication, estoppel or otherwise. Any such rights or licenses are or shall be granted only as expressly provided in the Supply Agreement.span>p>
<p><span style=”font–weight: 400;”><strong>5.9strong> The Parties acknowledge and agree that the Supply Agreement is not a “joint research agreement” as defined in 35 U.S.C. § 100(h), and neither Party shall invoke the America Invents Act Joint Research Agreement exception codified at 35 U.S.C. § 102(c) (or any equivalent law outside the United States) in exercising any of its rights under the Supply Agreement without the prior written consent of the other Party. span>p>
