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 within 90 days of contract award.
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. Biotest shall be solely responsible for the manufacture of Biotest Products in the Territory and Co-Developed Products in the Biotest Territory. The Parties shall prepare and provide to the JDC for its review and approval a Manufacturing Plan that specifies which manufacturer of MAY Compounds and Anti-[***] Antibody-MAY Conjugates are to be used for Biotest Products and/or Co-Developed Products and/or Preclinical Materials and/or Clinical Materials, which Manufacturing Plan shall be updated by the Parties and reviewed and approved by the JDC each Contract Year during the Term following the JDC’s approval of the initial Manufacturing Plan. Each update to the Manufacturing Plan shall: (a) set forth (i) the manufacturing scale-up, formulation and filling requirements for each Biotest Product and/or Co-Developed Product to be performed for the Contract Year covered by the Manufacturing Plan with reasonable specificity, (ii) a timeline and budget for such activities, (iii) the objectives and activities to be performed for each Contract Year period covered by the Manufacturing Plan with reasonable specificity, (iv) the Party that shall be responsible for performing such activities, (v) the estimated expenses covering the activities associated with the Manufacturing Plan; and (b) be consistent with the other terms of this Agreement. The JDC members shall use reasonable efforts to reach agreement on manufacturing issues. In the event that, despite such reasonable efforts, agreement on a particular matter cannot be reached by the JDC, the judgment of the Biotest Chairman shall be determinative. If the JDC requests that ImmunoGen manufacture Preclinical Materials and/or Clinical Materials, then the judgment of the ImmunoGen representatives on the JDC shall be determinative.
Manufacturing Plan. Within * (*) days of the Effective Date, DS will prepare and approve a plan for establishing manufacturing capabilities necessary for DS to manufacture the Licensed Product for use in the Territory (the “Manufacturing Plan”). Following review of the Manufacturing Plan at the JEC, DS will use Commercially Reasonable Efforts to complete the activities and establish manufacturing capabilities in accordance with such Manufacturing Plan. ARQULE will assist with such activities by providing DS with technical documentation as may be reasonably requested to inform DS about the Manufacturing process. Notwithstanding the foregoing, DS will (a) retain sole responsibility for the implementation and progress of the Manufacturing Plan and (b) provide ARQULE and the JEC with written notice upon its completion of the activities contemplated by the Manufacturing Plan (the “Manufacturing Plan Completion Notice”).
