Manufacturing Plan. The Contractor shall produce and deliver a Manufacturing Plan, fourteen (14) calendar days prior to the first PRR. The Manufacturing Plan (CDRL A028) shall show major milestones, including the planned schedule for conducting Production Acceptance Test in order to provide the opportunity for Government personnel to observe; and other major activities and milestones to facilitate Government monitoring of progress. The Government will either accept the Manufacturing Plan, or within seven (7) calendar days of plan receipt, request to engage in discussions regarding desired changes. The Monthly Status Report (CDRL A002) shall document performance and successful completion of all necessary testing including Production Acceptance Test (PAT)) and evaluation of systems/equipment/components or other contract production items to demonstrate that the procured items fulfill the requirements and specifications of the contract. Deliverable Data Item (See DD-1423): CDRL A002: “Contractor’s Progress, Status and Management Report” Deliverable Data Item (See DD-1423): CDRL A028: “Manufacturing Plan”
Manufacturing Plan. Except as otherwise provided in this Agreement, ViaCell shall be responsible for preparing and submitting the Manufacturing Plan section of the Program Plan with respect to Cell Therapy Products and Collaboration Products to and for approval by the JSC, and shall update the Manufacturing Plan on an [**] basis, [**]; provided however, it is acknowledged and agreed that the Manufacturing Plan may need to be modified from time to time based upon commercial considerations including unanticipated events. [**].
Manufacturing Plan. The Project Team shall prepare and oversee the implementation of a detailed, overall manufacturing plan, which shall address fully the key elements necessary for the clinical and commercial manufacture of the Bulk Drug Substance and the Drug Product and the roles of each party in the Manufacturing Program (the "MANUFACTURING PLAN").
Manufacturing Plan. The Manufacture of each Joint Product in the New Collaboration Field in the Territory to support ongoing or anticipated Commercialization of such Joint Product shall be conducted pursuant to a comprehensive manufacturing plan for such Joint Product (the “Manufacturing Plan”) that sets forth: (i) all significant work necessary to establish capacity for and to support ongoing or anticipated Commercialization of such Joint Product in the Territory, including the timeline therefor; (ii) the anticipated tasks and responsibilities and resource allocation of each Party both prior to and after launch; (iii) the annual projected Joint Product volume to be Manufactured both prior to and after launch; (iv) any backup plan for Manufacturing and supply in the event of a shortfall or non-performance of the primary Manufacturing arrangement; and (iv) a corresponding budget for such activities.
Manufacturing Plan. The Contractor shall submit to the COR a comprehensive manufacturing plan for review and approval no later than 60 days from the date of award. * Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.
Manufacturing Plan. The establishment of all facilities for the Manufacture of Product [***] and the Manufacture of Product in connection with the GDP and for commercial sale worldwide shall be conducted in accordance with a plan and budget established by the JMC (the “Manufacturing Plan”). The Manufacturing Plan shall (i) outline in reasonable detail the activities to be so conducted, (ii) reflect and be consistent with the provisions of this ARTICLE VI (and the other applicable terms of this Agreement), (iii) include such other matters as the JMC determines appropriate for the establishment and operation of such facilities and the Manufacture and supply of Product in the United States, the Xxxxxxx Territory and Greater China, including the site selection (as determined in accordance with this ARTICLE VI) and design of such facilities and (iv) include a budget for the FTE Costs, Out-of-Pocket Costs and Third Party Expenditures (collectively, the “Manufacturing Plan Costs”) [***]. Each Party shall use Diligent Efforts to conduct in accordance with the then-current Manufacturing Plan all activities assigned to it in accordance with such Plan. The Manufacturing Plan Costs incurred by the Parties in accordance with the Manufacturing Plan: (a) with respect to the United States and the Xxxxxxx Territory shall be shared equally by the Parties; and (b) with respect to Greater China shall be shared as follows: seventy percent (70%) shall be borne by Legend and thirty percent (30%) shall be borne by Xxxxxxx. Such Manufacturing Plan Costs shall be shared and reconciled in the same manner and at the same time as Development Costs (i.e., in the same manner as provided under Section 7.3 above).
Manufacturing Plan. The MT shall prepare a Manufacturing Plan for the Product for approval by the JSC, which shall [***]. The JSC shall review and approve such Manufacturing Plan, subject to Clause 25.3. The MT may amend the Manufacturing Plan from time to time, as appropriate, subject to the approval of any Substantive Amendments by the JSC.
Manufacturing Plan. Following the Effective Date, the JMC shall prepare, for approval by the CGB, a plan for the Manufacturing of API, Finished Manufacturing of Drug Product, and Packaging of Drug Product into Finished Product in the Territory consistent with the provisions of this Article 7 (the “Manufacturing Plan”). Following its approval by the CGB, on at least [*] (but in any event, no later than [*]), the JMC shall update and amend, as appropriate, the then-current Manufacturing Plan and shall submit such updates and/or amendments for review, comment and approval by the CGB. The Manufacturing Plan shall set forth (a) strategies for (i) Manufacturing activities necessary to supply the Parties’ needs for ongoing or anticipated Clinical Trials that are designed to support receipt of Regulatory Approval of the Product in the Territory; (ii) Manufacturing activities designed to explore alternative formulations of Products; and (iii) Manufacturing activities necessary to establish capacity for and to support ongoing or anticipated Commercialization of such Products in each of the Ovid Territory and the Takeda Territory; (b) the respective roles and responsibilities of the Parties in the conduct of such tasks (consistent with this Article 7); and (c) the agreed-upon budget for such tasks.
Manufacturing Plan. XOMA shall prepare and propose to the JMC for discussion purposes a detailed plan for CMC Activities, including process development and scale-up, Manufacture of Bulk Drug Substance, Manufacture of finished Product from Bulk Drug Substance, and any other matters related to the Manufacture of the Product, as well as a quarter-by-quarter budget for such activities (including direct costs, external costs, costs of raw materials, capital improvements required in connection therewith, and the like), such a detailed plan will be submitted for approval to the JSC (the “Manufacturing Plan”). The Manufacturing Plan will include only those capital expenditures by XOMA that are fully dedicated to the production of Bulk Drug Substance, and will provide allocations of costs for those costs that are shared between Bulk Drug Substance and other products of XOMA. An initial Manufacturing Plan for Development of the Product for Behçet’s Uveitis for calendar year 2011 is attached to this Agreement as Exhibit 6.2. The Parties, through the JMC, shall make good faith efforts to review such initial Manufacturing Plan and agree upon any revisions, amendments or additions thereto, for the Product for Behçet’s Uveitis and the Lead Cardiometabolic Indications for the subsequent [*] years, and have it approved by the JSC within [*] days after the Effective Date. On an annual basis, the JMC shall have prepared by XOMA and shall propose any amended or revised Manufacturing Plan for approval by the JSC by no later than [*] of each year, the budget for which shall govern the activities to be conducted during the following calendar year to enable appropriate scale up activity and financial planning.
Manufacturing Plan. The JV Parties shall use best efforts to cause the Joint Venture Company to prepare an annual manufacturing plan (the “Manufacturing Plan”) under the direction of the President, with input from the Executive Vice President, the JV Parties and the Manufacturing Committee (or such other persons or committees charged with such responsibility from time to time by the JV Parties). The Manufacturing Plan shall be updated quarterly by the Joint Venture Company and the Manufacturing Committee in accordance with the procedures set forth in the Supply Agreement. The Manufacturing Plan shall address various manufacturing issues, including without limitation, the DRAM Products to be manufactured, priority of wafer starts and weekly output.
