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. The responsibilities of the JMC will be to:
(a) generally facilitate flow of information between the Parties with respect to technical development and Manufacturing clinical supply of Candidates and Products to NVS, and, if applicable, commercial supply;
(b) coordinate and oversee the complete Manufacturing Know-How transfer related to each Candidate and Product to the NVS CMC Sub-Team, including with respect to host cell line history, raw materials used for cultivation, available licenses for commercial use, details about vectors, and process and analytical methods applied to Candidates and Products;
(c) coordinate, oversee, and approve the type and amount of assistance to be provided by or on behalf of HMI to NVS for any HMI Manufacturing Know-How transfer support requested by NVS pursuant to Section 8.6.2 (Manufacturing Technology Transfer to NVS) to permit NVS to Manufacture such Candidate(s) and Product(s);
(d) update NVS about the progress of the HMI facility build-up, or the need to engage Designated CMOs, as appropriate;
(e) provide transparency on planning and budget requirements with respect to preclinical and clinical supplies of Candidates and Products to permit each Party to meet its internal budget and planning processes;
(f) facilitate and align the Parties’ activities related to any NVS quality assurance audits of HMI’s and Designated CMOs’ facilities, including following up on critical audit findings and supporting the identification and implementations of potential solutions;
(g) select and approve the list of Designated CMOs;
(h) advise on the material terms of agreements entered into between HMI and Designated CMOs;
(i) oversee negotiation of the Development Supply Agreement, Commercial Supply Agreement, In-Vivo [***] Commercial Supply Agreement, and Quality Agreements, as appropriate; and
(j) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
Specific Responsibilities of the JMC. In addition to its overall responsibilities described in Section 2.3.1, subject to Section 2.7.2, the JMC shall, in particular:
(a) prepare, approve and amend the Marketing Plan for Collaboration Products in the US Territory;
(b) monitor the progress of the activities undertaken by the Parties pursuant to the Marketing Plan for the US Territory;
(c) manage the flow of information with respect to Commercialization activities in the US Territory for each Collaboration Product;
(d) coordinate and oversee the Parties’ plans for labeling and selecting trademarks for Collaboration Products in the US Territory;
(e) approve packaging designs, and plan and oversee non-independent educational and professional symposia, and speaker and peer-to-peer activity programs, for the Collaboration Products in the US Territory;
(f) discuss and suggest a range of suggested prices at which Collaboration Products will be sold to unaffiliated Third Parties in the US Territory and any discount strategies for Collaboration Products in the US Territory; provided that nothing contained herein, except as set forth in Section 4.2.2, shall limit or in any way restrict Shire from having the final decision on setting the price at which a Collaboration Product is sold; and
(g) recommend whether to seek new indications, formulations or uses for Collaboration Products in the US Territory, such as for Collaboration Product life cycle management, including the Development and Commercialization of an authorized generic of any Collaboration Product, for approval by the JDC.
Specific Responsibilities of the JMC. In addition to its general responsibility to oversee, monitor, review, coordinate and provide strategic direction to the commercialization of the Product for and in the Territory, the JMC shall in particular: (i) review, coordinate and approve all plans for marketing activities with respect to the Product in or for the Territory; ---------------------------------- * Confidential Treatment requested. 15. <PAGE> (ii) facilitate the flow of information between the Parties with respect to such activities for the Product in the Territory; (iii) oversee the activities of GSK Canada in marketing, selling and distributing the Product in the Territory, including pre-launch and post-launch activities; (iv) review and comment on the Marketing Plan and all updates thereto, as provided in Section 3.5; (v) monitor GSK Canada's compliance with the Marketing Plan; and (vi) perform any other functions set forth for the JMC in this Agreement.
Specific Responsibilities of the JMC. The JMC shall in particular, in accordance with the decision-making principles set forth in Section 2.9:
(i) discuss, approve and oversee implementation of and progress against the Global Research and Development Plans as they relate to CMC Activities;
(ii) review the Manufacturing Plan and associated budget and propose updates and amendments thereto to the JSC, for approval;
(iii) coordinate and facilitate cooperation and flow of Information between the Parties with respect to the Manufacture and supply of Bulk Drug Substance and the Product for clinical and commercial use in accordance with Article 6;
(iv) coordinate and facilitate the transfer from XOMA to Servier of the XOMA Know-How as and to the extent provided in Article 6; and
(v) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Manufacture of Bulk Drug Substance or the Product, as directed by the JSC or the JEC.
Specific Responsibilities of the JMC. The responsibilities of the JMC will be to:
Specific Responsibilities of the JMC. The JMC shall in particular, in accordance with the decision-making principles set forth in Section 2.4(c):
(i) coordinate and facilitate the transfer from Alder to BMS of the manufacturing technology and transition of manufacturing responsibilities from Alder to BMS in accordance with Article 6;
(ii) coordinate and facilitate cooperation between the Parties with respect to the manufacture by Alder and supply to BMS of Licensed Compound for use in Clinical Trials in accordance with Article 6;
(iii) in the case where the Joint Manufacturing Plan is prepared in accordance with Section 6.7, discuss and prepare the Joint Manufacturing Plan and amendments thereto and oversee implementation of the Joint Manufacturing Plan;
(iv) provide updates on the JMC’s activities to the JEC, JDC or JCC, as applicable; and
(v) perform such other duties as are expressly assigned to the JMC in this Agreement or as may be properly assigned to it by the JEC.
Specific Responsibilities of the JMC. In addition to its general responsibilities, the JMC shall, subject to the terms of this Agreement, in particular:
(a) coordinate the manufacturing activities of Beam and Verve under any Supply Agreement with respect to applicable Products in the Territory;
(b) for Collaboration Products, coordinate with the JDC to allocate appropriate amounts from the Development Budget to Manufacturing activities;
(c) facilitate the flow of information between the Parties with respect to the Manufacture of Collaboration Products and Opt-In Products;
(d) discuss, coordinate with the JDC and refer to the JSC for approval a clinical supply plan for Opt-In Products and Collaboration Products under Section 8.1;
(e) discuss, coordinate with the JDC and refer to the JSC for approval a commercial supply plan for Collaboration Products under Section 8.2;
(f) discuss and plan for manufacturing technology transfers as may be contemplated by this Agreement or a Supply Agreement, including on termination pursuant to Section 15.5.2(g); and
(g) perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC or as specified in this Agreement.
Specific Responsibilities of the JMC. Subject to any limitations under applicable Law, the respective applicable JMC will have the following responsibilities:
2.6.2.1 in consultation with the Finance Working Group, as part of the Manufacturing Plan, allocating responsibilities as between the Parties with respect to the right to [**], as described in Section 7.1 (Manufacturing Responsibilities);
2.6.2.2 preparing and approving Manufacturing Plans and amendments to then-current Manufacturing Plans for each Product Class and submit such amendments to the JSC to
Specific Responsibilities of the JMC. With respect to each Eisai Collaboration Product, the JMC shall have the following responsibilities subject to oversight of the JSC and in accordance with Section 3.1:
(A) managing the supply chain for such Eisai Collaboration Product;
(B) monitoring logistical strategies, capacity planning and inventory levels for (1) Clinical Studies and (2) Commercialization in the Field in the Territory for such Eisai Collaboration Product; and
(C) providing a forum for the Parties to discuss any material quality-related issues concerning such Eisai Collaboration Product.
