Common use of Joint Manufacturing Committee Clause in Contracts

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 the Initial Target Program and the Second Target Program (if Adaptimmune conducts manufacturing activities under the Second Target Program), as the case may be, and completion of the technology transfer requirements set forth in Section 6.11 and Schedule 7 as they relate to the Initial Target Program and Second Target Program, respectively.

Appears in 3 contracts

Samples: Collaboration and Licence Agreement (Adaptimmune Therapeutics PLC), Collaboration and Licence Agreement (Adaptimmune Therapeutics PLC), Collaboration and Licence Agreement (Adaptimmune LTD)

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Joint Manufacturing Committee. (a) The Parties shall form establish a Joint Manufacturing Committee joint manufacturing committee (“JMC”) as a Sub-committee to oversee the JSCsupply of Product to Licensee in accordance with this Agreement. The JMC shall be formed within consist of three (3) representatives designated by each Party. One (1) representative from each Party shall alternate in acting as the chairperson of the JMC for one Calendar Year term, with Acorda’s representative chairing the JMC for the first Calendar Year. The chairperson shall not have any greater authority than any other representative on the JMC. As soon as practicable following the Effective Date (but in no event more than thirty (30) days after following the Effective Date and shall include three (3) representatives from Date), each Party (shall designate its initial representatives on the JMC. Each Party shall be free to change its representatives on notice to the other or such other number as mutually agreed by to send a substitute representative to any JMC meeting; provided, however, that each Party shall ensure that at all times during the Parties), in each case suitably qualified to assist in the development and co-ordination existence of the JMC, its representatives on such committee are appropriate in terms of seniority and expertise with respect to the manufacturing process development forming part of pharmaceutical products and have the authority to bind such Party with respect to matters within the purview of the Initial Target ProgramJMC. Except as expressly provided in this Agreement, including processthe JMC shall have no authority to bind the Parties hereunder and the JMC shall report to the JSC, analytical, quality and supply expertisesubject to Section 2.4 of this Agreement. (b) The JMC shall meet on be responsible for (i) managing the supply chain for Product in the Territory; (ii) monitoring logistical strategies, capacity planning and inventory levels for the Product for Commercialization in the Field in the Territory; and (iii) providing 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 forum for the Parties during to discuss any material quality-related issues concerning the term Product. 5 Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Securities and Exchange Commission. (c) The appointment of members of the applicable Collaboration ProgramJMC is a right of each Party and not an obligation and shall not be a “deliverable” as referenced in any existing authoritative accounting literature. Each Party may, subject shall be free to determine not to appoint members to the other Party’s prior approval, invite non-member representatives of such JMC. If a Party to attend meetings does not appoint members of the JMC as non-voting participantsJMC, subject to the confidentiality obligations it shall not be a breach of Article 10this Agreement, as may nor shall any consideration be required by to be returned, and unless and until such persons are appointed, all decisions and obligations within 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 purview of the manufacturing process development activity within committee shall henceforth be handled directly between the Initial Target Program including proposing amendments to Parties; provided, that in the Development Plan regarding such manufacturing processes for review by JSC. The JMC shall also identify event of any manufacturing process decisions which will result in any CMO or other Third Party capital expenditure to be approved and reimbursed by GSK as disputes between the Parties, the dispute resolution procedures set forth in Section 3.10 and will be 2.4(a) shall continue to apply (substituting in such provision references to “the forum at which Adaptimmune shall keep GSK informed Parties” instead 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 the Initial Target Program and the Second Target Program (if Adaptimmune conducts manufacturing activities under the Second Target Program), as the case may be, and completion of the technology transfer requirements set forth in Section 6.11 and Schedule 7 as they relate to the Initial Target Program and Second Target Program, respectively.2.3

Appears in 1 contract

Samples: Collaboration and License Agreement and Supply Agreement

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