Common use of Specific Responsibilities of the JMC Clause in Contracts

Specific Responsibilities of the JMC. In support of its responsibility for overseeing the Manufacturing of Product on a worldwide basis the JMC shall meet at least quarterly or with such higher frequency, and at such time and location as may be established by the JMC, and the JMC shall perform the following activities: (i) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Product and for supply of Product in the Auxilium Territory; (ii) together with the Joint Development Committee, develop a manufacturing strategy to enable development and licensure of manufacturing processes and facilities for Product in the Auxilium Territory that includes all aspects of manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, stability studies and manufacturing plans and forecasts; (iii) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Product in the Auxilium Territory; (iv) together with the Joint Development Committee review and comment on the process for Product Development and the drafting and contents of the CMC section of a Drug Approval Application for Product in the Auxilium Territory; (v) review technology transfer plans for any changes in manufacturing sites, testing sites, and responsibilities in the supply chain for Product for the Auxilium Territory, it being understood that decisions regarding the selection of which of a Party’s own manufacturing and testing sites shall be used to manufacture any component of a Product, if a Party manufactures any component of a Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; (vi) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Product; and (vii) review quality compliance and manufacturing related regulatory issues concerning the Product in the Auxilium Territory or any component thereof as important issues arise through meetings and review of relevant written material produced by Auxilium, BTC or any Regulatory Authority.

Specific Responsibilities of the JMC. In support of its responsibility for overseeing the Manufacturing of Product on a worldwide basis the JMC shall meet at least quarterly or with such higher frequency, and at such time and location as may be established by the JMC, and the JMC shall perform the following activities: (i) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Product and for supply of Product in the Auxilium Territory; (ii) together with the Joint Development Committee, develop a manufacturing strategy to enable development and licensure of manufacturing processes and facilities for Product in the Auxilium Territory that includes all aspects of manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, stability studies and manufacturing plans and forecasts; (iii) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Product in the Auxilium TerritoryProduct; (iv) together with the Joint Development Committee review and comment on the process for Product Development and the drafting and contents of the CMC section of a Drug Approval Application for Product in the Auxilium TerritoryProduct; (v) review technology transfer plans for any changes in manufacturing sites, testing sites, and responsibilities in the supply chain for Product for the Auxilium TerritoryProduct, it being understood that decisions regarding the selection of which of a Party’s own manufacturing and testing sites shall be used to manufacture any component of a Product, if a Party manufactures any component of a Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; (vi) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Product; and (vii) review quality compliance and manufacturing related regulatory issues concerning the Product in the Auxilium Territory or any component thereof as important issues arise through meetings and review of relevant written material produced by Auxilium, BTC or any Regulatory Authority.

Specific Responsibilities of the JMC. In support of its responsibility for overseeing the Manufacturing manufacturing of Licensed Product on a worldwide basis the JMC shall meet at least quarterly or with such higher frequencybasis, and at such time and location as may be established by the JMC, and the JMC shall perform the following activities: (i) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Licensed Product and for supply of Licensed Product in the Auxilium Territory; (ii) together with the Joint Development Committee, jointly develop a manufacturing strategy for the Development Plan and Annual Plan and Budget to enable development and licensure of manufacturing processes and facilities for Licensed Product in the Auxilium Territory that includes all aspects of manufacture and release, including but not limited to formulations, intermediateIntermediate, dosage form, devices, product characterization studies, stability studies and manufacturing plans and forecasts; (iii) determine Manufacturing Plans and Budgets, and allocate responsibilities for and oversee the implementation of such plans in accordance with this Agreement; (iv) oversee and approve process development plans prior to the manufacture of registration batches of Licensed Product; (v) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications Specifications and quality standards for Product in the Auxilium TerritoryLicensed Product; (ivvi) together subject to Section 2.5(b)(xiv), approve the terms of any supply agreement involving either Party that affects the supply of Intermediate, E2F Decoy, Vialed Product, Licensed Device or Final Product that will be used to develop or Commercialize Licensed Product; (vii) coordinate with the Joint Development Committee review and comment on the process for Product Development and RWG the drafting and contents of the CMC Chemistry, Manufacturing and Controls section of a Drug Approval Application for Product in the Auxilium TerritoryLicensed Product; (vviii) review and approve technology transfer plans for any changes in manufacturing sites, testing sites, and responsibilities in the supply chain for Product for the Auxilium TerritoryLicensed Product, it being understood that decisions regarding the selection of which of a Party’s 's own manufacturing and testing sites shall be used to manufacture any component of a Licensed Product, if a Party manufactures any component of a Licensed Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party; (viix) prepare for regulatory inspections and ensure adherence to compliance standards with respect to Licensed Product; (x) ensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Pre-Launch Marketing Plan and Budget and each Marketing Plan and Budget, as well as inventory levels for Licensed Product; (xi) review quality-related issues concerning the Licensed Product or any component thereof; (xii) coordinate with the JCC, JDC and JFC as appropriate; (xiii) provide updates on the JMC's activities and achievements to the JSC, as appropriate; and (viixiv) review quality compliance and manufacturing related regulatory issues concerning approve any significant agreements, purchase orders or amendments (generally involving an expense of more than [*]) with Third Parties to be entered into by either or both Parties that cover the manufacture of Intermediate, E2F Decoy, Vialed Product, Licensed Device or Final Product for sale and use in the Auxilium Territory or any component thereof as important issues arise through meetings and review of relevant written material produced by Auxilium, BTC or any Regulatory AuthorityTerritory.