CMC Working Group Sample Clauses

The CMC Working Group clause establishes a designated group responsible for overseeing and coordinating activities related to the Contract Management Committee (CMC). This group typically consists of representatives from the parties involved and meets regularly to discuss project progress, resolve issues, and make recommendations on contract administration. By formalizing the structure and responsibilities of the working group, the clause ensures effective communication, collaborative problem-solving, and streamlined decision-making throughout the contract's duration.
CMC Working Group. Without limiting Section ‎2.3.1, within [***] after its formation, the JDT shall establish a CMC working group (the “CMC Working Group”) to coordinate the CMC Development and Manufacturing activities performed by or on behalf of the Parties in accordance with this Agreement. The CMC Working Group shall meet at least [***] or as otherwise determined by the JDT; provided that the CMC Working Group, in its reasonable discretion, may decide to cancel or reschedule meetings. The CMC Working Group may meet in person, by videoconference or by teleconference as determined by the JDT. Subject to Section ‎2.3.1 and Section ‎3.3, the CMC Working Group shall (a) serve as a forum for discussing and coordinating the CMC Development and Manufacturing activities, including with respect to [***] (b) encourage and facilitate ongoing communication and cooperation between the Parties with respect to the CMC Development and Manufacturing activities and the progress thereof; (c) seek to resolve any issues or delays with respect to the development of the Phase 3 Process and the Commercial Process; (d) periodically discuss the Parties’ respective supply chains, plans and process development activities and coordinate to identify any efficiencies with respect thereto; and (e) perform such other functions as determined by the JDT.
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CMC Working Group. The JDC will establish a chemistry, manufacturing and controls working group (“CMC Working Group”) to coordinate the transfer of Manufacturing activities to Biogen and to assist the JDC in its responsibility with respect to the review and resolution of Manufacturing matters.
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CMC Working Group. Within [***] after the Effective Date, the Parties shall establish a CMC working group (the “CMC Working Group”). The CMC Working Group shall consist of two (2) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the CMC Working Group. From time to time, each Party may substitute one (1) or more of its representatives to the CMC Working Group on written notice to the other Party. In particular, the CMC Working Group shall: (a) review and approve [***] with respect thereto, and review and approve amendments thereto; and (b) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
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CMC Working Group. The JDC shall establish a chemistry, manufacturing and controls Working Group (“CMC Working Group”) to coordinate the Manufacturing Transfer activities by the Parties as set forth in Section 4.2 (Manufacturing Transfer) and to assist the JDC in its responsibility with respect to the review and resolution of Manufacturing matters. The CMC Working Group shall meet at least once per Calendar Quarter, or as otherwise agreed to by the CMC Working Group. Each Party may refer disagreements between the representatives of Biogen and Denali on the CMC Working Group with respect to substantial matters ([***]) to the JDC or JCC, as applicable, for resolution in accordance with Section 2.4.5 (Joint Committee Decision-Making), provided that, in any event, the Manufacturing Party shall lead day-to-day implementation and operational management of its performance of the Manufacturing activities under this Definitive LRRK2 Agreement. [***]
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CMC Working Group. Subject to Section 3.1.9(a) (Working Groups), the JGC shall establish a CMC Working Group (the “CMC Working Group”) promptly after the JGC’s formation that shall be responsible for Manufacturing and supply matters delegated to it by the JGC. The CMC Working Group shall consist of an equal (and agreed upon) number of representatives from each of the Parties, each with the requisite experience and seniority to enable such person to oversee and make decisions regarding CMC activities and matters under this Agreement. From time to time, each Party may substitute one (1) or more of its representatives to the CMC Working Group on written notice to the other Party. The CMC Working Group shall meet [†], or as otherwise mutually agreed to by the Parties, with the location of such meetings to be mutually agreed by the Parties. The CMC Working Group shall be subject to the oversight, review and approval of, and shall report to, the JGC. All decisions of the CMC Working Group shall be by consensus and any disagreements among the representatives of the CMC Working Group shall be referred to the JGC for resolution.
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Related to CMC Working Group

  • Working Group 1. The Parties hereby establish a Working Group on Temporary Entry for Business Persons, which shall meet at least once every 3 years or on request of the Free Trade Commission to consider any matter arising under this Chapter. 2. The Working Group's functions shall include: (a) to review the implementation and operation of this Chapter; (b) to consider the development of measures to further facilitate temporary entry of business persons on a reciprocal basis; (c) the identification of measures that affect the temporary entry of business persons under this Chapter; and (d) the observance of the issues established under Article 121 (Cooperation).

  • Working Groups From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a “Working Group”) on an “as-needed” basis to oversee particular projects or activities (e.g., joint project team, joint finance group, or joint intellectual property group). Each such Working Group shall be constituted and shall operate as the Joint Committee determines; provided, that each Working Group shall have equal representation from each Party, unless otherwise mutually agreed. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the Joint Committee may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the Joint Committee that formed said Working Group. In no event shall the authority of the Working Group exceed that specified for the Joint Committee that formed the Working Group. All decisions of a Working Group shall be by unanimous agreement. Any disagreement between the designees of AbbVie and Ablynx on a Working Group shall be referred to the Joint Committee that formed the Working Group for resolution.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Supplier Development lf the Buyer identifies problems in supplier performance based on supplier monitoring, he shall initiate improvement measures at the Supplier. The Buyer shall pursue the possibilities of continuous improvement of the Supplier. The supplier audit is a form of supplier development; the exchange of information and experience between the Buyer and the Supplier also serves this purpose.