Joint Manufacturing Committee. The Parties shall establish a joint manufacturing committee (“Joint Manufacturing Committee” or “JMC”).
Joint Manufacturing Committee. Promptly after the Effective Date, the JSC shall establish a joint manufacturing committee (“JMC”). The JMC shall have the primary responsibility for the matters set forth in 3.1.2(g).
Joint Manufacturing Committee. The Parties shall form a Joint Manufacturing Committee (“JMC”) as a Sub-committee to the JSC. The JMC shall be formed within thirty (30) days after the Effective Date and shall include three (3) representatives from each Party (or such other number as mutually agreed by the Parties), in each case suitably qualified to assist in the development and co-ordination of the manufacturing process development forming part of the Initial Target Program, including process, analytical, quality and supply expertise. The JMC shall meet on a monthly basis (or more or less frequently as agreed by the Parties) at Adaptimmune’s facilities, GSK’s facilities or via teleconference at such times as may be agreed by the Parties during the term of the applicable Collaboration Program. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party to attend meetings of the JMC as non-voting participants, subject to the confidentiality obligations of Article 10, as may be required by the agenda for such meetings. The JMC will coordinate with the JPT assigned to the Initial Target Program as required or useful, will report to the JSC and will be responsible for the day-to-day management of the manufacturing process development activity within the Initial Target Program including proposing amendments to the Development Plan regarding such manufacturing processes for review by JSC. The JMC shall also identify any manufacturing process decisions which will result in any CMO or other Third Party capital expenditure to be approved and reimbursed by GSK as set forth in Section 3.10 and will be the forum at which Adaptimmune shall keep GSK informed of any quality or compliance issues or financial issues with Adaptimmune’s CMOs of which Adaptimmune becomes aware. For clarity any such expenditure shall need to be prior approved by GSK in writing before being incurred. All decisions of the JMC on matters for which it has responsibility shall be made unanimously. In the event that the JMC is unable to reach a unanimous decision within ten (10) Business Days after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have such issue submitted to the JSC for resolution in accordance with Section 4.5. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JMC, including all travel and living expenses. The JMC shall automatically cease to exist on completion of th...
Joint Manufacturing Committee. Within [***] after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (or “JMC”) as a subcommittee of the JSC. The JMC shall have an initial term of [***] and shall [***] for successive [***]. The JMC shall have only the powers assigned expressly to it in this Section 3.13 and elsewhere in this Agreement, and the JMC shall not have any power to amend, modify or waive compliance with this Agreement. The JMC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Manufacture, Development and Commercialization of Licensed Products. The role of the JMC shall be to:
(a) oversee the conduct of the Manufacturing of the Licensed Product by or on behalf of SGI and MPI under this Agreement, the Non-Commercial Supply Agreement and the Commercial Supply Agreement;
(b) develop, update and annually approve a global plan for Manufacturing the Licensed Product, which plan shall include the strategy for the Manufacturing of the Licensed Product on a worldwide basis, and may include certain shared global Manufacturing activities (i.e., activities that benefit the Licensed Product in both the SGI Territory and the Licensed Territory, including such activities that relate to further process development, quality control release testing and quality assurance disposition, and inventory management, and, subject to mutual written agreement of the Parties, the appropriate allocation of responsibilities and, if applicable, [***]);
(c) facilitate the sharing of information between the Parties as necessary to support the Manufacturing of the Licensed Product;
(d) oversee the implementation of the global plans for the Manufacturing of the Licensed Product and the introduction of second sourcing and/or Manufacturing process improvements for the Licensed Product; and
(e) perform such other functions as appropriate to further the purposes of this Agreement, as mutually determined by the Parties.
Joint Manufacturing Committee. The Parties shall establish a joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”), composed of up to [*] of each Party that have [*] in the manufacture of compounds and products similar to the Compounds and Collaboration Products, to monitor and oversee the CMC Activities and other activities related to the Manufacture of the Compounds and Collaboration Products for use under the Collaboration. All JMC representatives will have sufficient authority within the applicable Party to make decisions [*] arising within the scope of the JMC’s responsibilities. The JMC shall in particular:
(a) discuss, approve and oversee implementation of and progress against the Development Plan and Commercialization Plan as they relate to CMC Activities;
(b) coordinate and facilitate cooperation and flow of information between the Parties with respect to the Manufacture and supply of the Compounds and Collaboration Products for Development and Commercialization use in accordance with Article 8;
(c) coordinate and facilitate the transfer of Manufacturing Know-How as and to the extent provided in Article 8;
(d) establish joint subcommittees, as appropriate, to carry out its functions; and
(e) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Manufacture of Compounds and Collaboration Products, as directed by the JDC or JCC (as applicable).
Joint Manufacturing Committee. Within [...***...] after the Effective Date, argenx and Xxxxxxx shall establish a joint Manufacturing committee (the “JMC”). The JMC shall: (i) oversee and coordinate CMC development and manufacturing matters with respect to the Lead Anti-CD70 Antibody and the Licensed Product containing the Lead Anti-CD70 Antibody, including technology transfer; (ii) promptly after the Effective Date, mutually agree and update the draft CMC Plan attached hereto as Exhibit F; and (iii) perform the other functions that are expressly delegated to the JMC in this Agreement. The JMC shall include individuals from each Party with reasonable expertise in the area of Manufacturing of biological products.
Joint Manufacturing Committee. Within thirty (30) calendar days following the Effective Date, the Parties shall establish a Joint Manufacturing Committee to oversee the manufacturing and Delivery of Product under this Agreement (the “JMC”). The JMC shall be composed of five (5) Representatives from each Party or its Affiliates (each Representative as selected by such Party in its sole discretion), and shall meet (whether in person or by teleconference) twice per calendar year starting from the Effective Date to ensure the orderly fulfillment of both Parties’ obligations under this Agreement.
Joint Manufacturing Committee. Working with the JDC and JCC, as appropriate, the Joint Manufacturing Committee shall be responsible for overseeing process development and Manufacturing activities, including preparing and updating the Manufacturing Plan for approval by the JSC and carrying out such other responsibilities set forth in Article VIII, process and technology selection, process improvements and related intellectual property filing strategy and obtaining a common process for manufacturing, recalls, market withdrawals, and any other corrective actions related to any Licensed Product in the Territory, and for any other matters specifically assigned to the JMC by the JSC. For process development activities, the Joint Manufacturing Committee shall consult the appropriate expert functions within both Parties or their Affiliates as appropriate.
Joint Manufacturing Committee. (a) BTC and Auxilium will establish a Joint Manufacturing Committee (the “JMC”) made up of two (2) representatives designated by each Party hereto which shall oversee the scale-up and manufacturing of Product on a worldwide basis, including the planning, manufacturing and supply (including supply chain management). Each of BTC and Auxilium shall have one vote on the JMC. The objective of the JMC shall be to reach agreement by consensus on all matters falling within its authority hereunder. In the event of a deadlock with respect to any action involving or related to the manufacture of clinical supplies of Product, the vote of Auxilium, after reasonable opportunity for open discussion among the members of the JMC, shall control. In the event of a deadlock with respect to any action involving or related to the manufacture of commercial supplies of Product in the Auxilium Territory, the vote of Auxilium after reasonable opportunity for open discussion among the members of the JMC shall control until such time as BTC is providing Auxilium with fifty percent (50%) of its commercial supplies in the Auxilium Territory pursuant to the terms of this Agreement. At that point, in the event of a deadlock with respect to any action involving or related to the manufacture of commercial supplies of Product for the Auxilium Territory, the vote of BTC after reasonable opportunity for open discussion among the members of the JMC shall control.
Joint Manufacturing Committee. Within [**] following the Effective Date, the Parties shall establish the JMC and the JMC shall hold its first meeting. The JMC shall:
(a) oversee and coordinate the clinical supply of Licensed Products to Hutchmed for Hutchmed’s Development activities in the Territory;
(b) oversee and coordinate the Manufacturing Technology Transfer (including determining the activities and budget required for the Manufacturing Technology Transfer and timing thereof, and oversee implementation of the Manufacturing Technology Transfer) to Hutchmed for the Manufacture of Drug Product in the Territory by Hutchmed for Development and Commercialization in the Territory;
(c) oversee and coordinate the Manufacturing Technology Transfer (including determining the activities and budget required for the Manufacturing Technology Transfer and timing thereof, and oversee implementation of the Manufacturing Technology Transfer) to Hutchmed or its Permitted Subcontractor CMO (if such Permitted Subcontractor CMO has been approved by the JMC) for the Manufacture of Drug Substance in the Territory by Hutchmed or such Permitted Subcontractor CMO for Development and Commercialization in the Territory;
(d) with respect to any quantities of Drug Product, if any, to be supplied by Epizyme for Commercialization by Hutchmed in the Territory prior to Manufacturing Technology Transfer Completion, oversee and coordinate the commercial supply of Drug Product to Hutchmed for Hutchmed’s Commercialization of Licensed Products in the Territory;
(e) oversee and coordinate proposed and planned Manufacturing Activities, including approving the budget for Manufacturing Activity Costs to be incurred and monitor the Parties’ activities and expenses against such budget;
(f) subject to Section 1.145(b), approve a Permitted Subcontractor CMO, if any, for the Manufacture of Drug Substance on behalf of Hutchmed in the Territory following the Manufacturing Technology Transfer;
(g) discuss and approve the content of CMC module (Module 3 or its equivalent) of any IND and Drug Approval Application filing for the Licensed Product in the Territory, and approve the regulatory strategy for the CMC meetings with the Regulatory Authorities;
(h) discuss any updates regarding the development or implementation of any Manufacturing Activity under Section 7.4; and
(i) determine whether to create any Subcommittee, and perform such other duties as are specifically assigned to the JMC under this Agreement or under the Clinical Suppl...
