Joint Manufacturing Working Group Sample Clauses

Joint Manufacturing Working Group. Within [***] of the formation of the JSC, the Parties shall establish a working group that will be responsible for Manufacturing and supply matters delegated to it by the JDC, including preparing and approving the Manufacturing Technology Transfer Plan (the “Joint Manufacturing Working Group”). The Joint Manufacturing Working Group shall consist of an equal (and agreed upon) number of representatives from each of the Parties, each being an employee of such Party and having appropriate technical credentials, experience, knowledge, and authority within such Party’s organization for service on the Joint Manufacturing Working Group to oversee and make decisions regarding CMC Development activities and other Manufacturing matters under this Agreement. The Joint Manufacturing Working Group shall meet as frequently as necessary to carry out its duties under this Section ‎3.1(e). Each Party may designate a substitute employee for one or more of its Joint Manufacturing Working Group representatives if one or more of such Party’s designated representatives is unable to be present at a meeting. From time to time, each Party may replace a representative by written notice to the other Party specifying the prior representative and his or her employee replacement. The Joint Manufacturing Working Group shall be subject to the oversight, review and approval of, and shall report to, the JSC.
Sample 1
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Joint Manufacturing Working Group. As soon as reasonably possible and in any event within [***] after the Effective Date, the Parties shall establish a joint manufacturing working group (“JMWG”), which shall consist of at least [***] of each Party, unless otherwise agreed by the Parties. The JMWG shall provide a forum for the exchange of information between the Parties with respect to the CMC matters, including visit of Kissei’s experts to CMO’s site during manufacturing the Collaboration Compound and Product, securing close communication among CG, its CMOs and Kissei, discussing the CMC regulatory strategies in and outside the Territory, and other CMC matters agreed by the JMWG.
Sample 1
Joint Manufacturing Working Group 
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Related to Joint Manufacturing Working Group

  • 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:

  • 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 [***].

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

  • 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 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.

  • 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.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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