Manufacturing Subcommittee Sample Clauses

Manufacturing Subcommittee. (a) The MSC shall consist of members from each of Eyetech and Pfizer, each of which shall confirm to the other its designees. The MSC shall be responsible for:
Sample 1Sample 2Sample 3
AutoNDA by SimpleDocs
Manufacturing Subcommittee. Within [**] days after the Effective Date, the Parties will establish a Subcommittee under the JDC for Manufacturing (including CMC) related matters, which shall initially be with respect to DOT1L (and thereafter, with respect to each Selected Target at the time a Compound Directed to such Selected Target meets the Development Candidate Selection Criteria pursuant to Section 2.2.5) (the “Manufacturing Subcommittee”). Notwithstanding anything to the contrary in this Agreement, on a Licensed Compound-by-Licensed Compound basis, (i) prior to Achievement of Proof of Concept, EPIZYME shall have final decision-making authority with respect to all Manufacturing matters in such CMC Subcommittee and (ii) after Achievement of Proof of Concept, [**] shall have final decision-making authority with respect to all such matters; provided that, nothing in this Section 4.4.3(a) shall [**]. Prior to Achievement of Proof of Concept with respect to the applicable Licensed Compound, in the event CELGENE desires to use or transfer to a Third Party any Manufacturing process selected by EPIZYME on behalf of the Collaboration in connection with an applicable Licensed Compound, Licensed Product or related Diagnostic Product and EPIZYME does not desire to move the related Manufacturing activities, upon CELGENE’s written request, EPIZYME shall provide a technology transfer of the relevant Know-How to a Third Party designated by CELGENE, at CELGENE’s cost and expense, in order to enable CELGENE to establish an alternative Manufacturing capability.
Sample 1Sample 2
Manufacturing Subcommittee. Promptly after the Amgen Option Effective Date, the Parties shall establish a manufacturing subcommittee to manage, oversee, facilitate and coordinate the transfer of manufacturing information and protocols by, and transition manufacturing from, CK to Amgen. Each Party will have representation on the Manufacturing Subcommittee throughout the Development Program, and the Manufacturing Subcommittee shall be subordinate to and governed by the JDC.
Sample 1
Manufacturing Subcommittee. 2.5.1 Within [***] calendar days following the Effective Date, each Party shall appoint [***] representative as its chair-person for the manufacturing and may appoint additional non-voting representatives (the “Manufacturing Subcommittee” or “MSC”) and give notice of the name and contact information of its respective subcommittee representative(s) to the other Party.
Sample 1
Manufacturing Subcommittee. (a) In accordance with the Settlement and Termination Agreement, the OUSOC shall establish a manufacturing subcommittee (the “Manufacturing Subcommittee”), which shall (i) coordinate and oversee supply chain activities for the EQW Product, including Components, (ii) coordinate and oversee Manufacturing Transition Activities with respect to the EQW Product, and (iii) serve as a forum for communication with respect to any supply chain issues and the Manufacturing Transition Activities relating to the EQW Product. The Manufacturing Subcommittee shall meet as frequently as reasonably necessary to perform their obligations as described herein.
Sample 1
Manufacturing Subcommittee. (a) In accordance with the Settlement and Termination Agreement, the OUSOC shall establish a manufacturing subcommittee (the “Manufacturing Subcommittee”), which shall (i) coordinate and oversee supply chain activities for the Products and (ii) serve as a forum for communication with respect to any supply chain issues and the Manufacturing Transition Activities relating to the Products. The Manufacturing Subcommittee shall meet as frequently as reasonably necessary to perform their obligations as described herein.
Sample 1

Related to Manufacturing Subcommittee

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Steering Committee Each Party shall name a mutually agreed upon equal number of representatives for the Steering Committee, which shall meet twice per calendar year, or as otherwise mutually agreed by the Parties. In the event that a Steering Committee dispute cannot be resolved, such dispute shall be escalated to a senior executive of each of Customer and Lonza. The primary function of the Steering Committee is to ensure the ongoing communication between the Parties and discuss and resolve any issues arising under this Agreement. In addition to the primary function described above, the Steering Committee shall also take on the following responsibilities:

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Research Committee 2.2.1 Establishment and Functions of the RC. -------------------------------------

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Development Plan As defined in Section 3.2(a).

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

Time is Money Join Law Insider Premium to draft better contracts faster.