CMC Working Group Sample Clauses

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.
Sample 1
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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.
Sample 1
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.
Sample 1
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. [***]
Sample 1
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:
Sample 1

Related to CMC Working Group

  • 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.

  • Joint Manufacturing Committee Promptly after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to oversee Manufacturing activities related to the Territory, subject to the terms of this Agreement and the oversight of the JSC. The JMC shall be responsible, without limitation, for the following:

  • 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 Concession Area, including its abandonment.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Project Leaders Within [**] Business Days after the Effective Date, each Party will appoint (and provide written notice to the other Party of the identity of) a senior representative having a general understanding of biopharmaceutical discovery and development issues to act as its project leader under this Agreement (each, a “Project Leader”). The Project Leaders will serve as the contact point between the Parties with respect to the Research Program, and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination of the day-to-day work and collaboration between the Parties; (b) providing single point communication for seeking consensus internally within the respective Party’s organization; and (c) raising cross-Party or cross-functional disputes in a timely manner. The Project Leaders shall conduct regular telephone conferences as deemed necessary or appropriate, to exchange informal information regarding the progress of the Research Program. Each Party may change its designated Project Leader from time to time upon prior written notice to the other Party. Each Project Leader may designate a substitute to temporarily perform the functions of that Project Leader by prior written notice to the other Party.

  • Joint Project Team As soon as possible after the Effective Date, the Parties shall establish a joint project team (the “JPT”) which shall be initially responsible for the day-to-day operations of the Initial Target Program. The JPT shall also be responsible for the day-to-day operations of all other Collaboration Programs when they become ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. effective; provided, that if multiple JPTs are needed due to different Targets or disease areas, then the Parties may establish separate JPTs for different Collaboration Programs. The JPT shall be comprised of representatives from each of GSK and Adaptimmune with the appropriate scientific expertise with respect to the conduct of the Development Plans (and such representatives may vary depending on the relevant Project Phase) and 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. The JPT will report to the JSC and will be responsible for the day-to-day management of the conduct of the Development Plans including any non-material changes to the Development Plans, overseeing the conduct of experiments and reviewing data resulting from such experiments as set forth in the Development Plans, proposing amendments to the Development Plans, proposing new Development Plans to the JSC for new Collaboration Programs for JSC approval, discussing potential Lead Candidates and Development Candidates for proposal to the JSC. All decisions of the JPT on matters for which it has responsibility shall be made unanimously. In the event that the JPT 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 JPT, including all travel and living expenses. Each JPT shall automatically cease to exist on completion of the relevant Collaboration Programs that it supports and exercise or expiry of all Collaboration Program Options applicable to such Collaboration Programs.

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