MANUFACTURING PLANS Clause Samples
The Manufacturing Plans clause outlines the requirements and procedures for preparing, submitting, and approving detailed plans related to the production of goods or components under a contract. Typically, this clause specifies the format, timing, and content of the manufacturing plans that the supplier must provide to the buyer, such as production schedules, quality control measures, and resource allocation. By establishing clear expectations and review processes, the clause ensures that both parties are aligned on how manufacturing will proceed, thereby reducing the risk of delays, misunderstandings, or quality issues during production.
MANUFACTURING PLANS. The Supplier is responsible for maintaining documented records of the manufacturing processes, steps, sequences, verifications, and qualifications. ▇▇▇▇▇▇ has the right to request the Supplier to submit evidence of any manufacturing plans or special processes if required.
MANUFACTURING PLANS. (a) Focal represents and warrants that it currently has sufficient capacity to supply all requirements of Ciba and/or Chiron for Products for [*].
(b) As soon as reasonably practicable following commencement of [*], Focal shall prepare a reasonable manufacturing plan for development by Focal of the necessary capacity to supply the reasonable requirements of the Developing Party for the [*].
(c) As soon as is reasonably practicable following commencement of [*], Focal shall present for review and comment in the Manufacturing Committee and approval by the Developing Party, which approval shall not be unreasonably withheld, a process and manufacturing development plan pursuant to which Focal will (i) supply all of the Developing Party's reasonable requirements of such Product for [*];
MANUFACTURING PLANS. The parties acknowledge that, except in the circumstances specified in Section 4.1 of the Supply Agreement, Nucryst will, to the extent Nucryst agrees in writing to do so, acting reasonably in the manner described in Section 3.2.2, be responsible for the manufacture and supply of New Products or Improvements to Products in the Territory, all as specified in the Supply Agreement. Notwithstanding the foregoing and subject to its obligations under the Supply Agreement, Nucryst shall present to the Project Team annually for its review and consultation, beginning a reasonable period of time prior to launch of a particular Product in the Territory, a Commercial Manufacturing Plan, and will not make any material revisions to a previously reviewed Commercial Manufacturing Plan without prior consultation with the Project Team. Nucryst will consider seriously any comments that S&N representatives to the Project Team may have with respect to any such Commercial Manufacturing Plan or material revision thereto, provided, however, that the final decision on any such matter shall be made by Nucryst, acting reasonably in the manner described in Section 3.2.2.
MANUFACTURING PLANS. The Supplier is responsible for maintaining documented records of the manufacturing processes, steps, sequences, verifications, and qualifications. Kampi has the right to request the Supplier to submit evidence of any manufacturing plans or special processes if required. Changes in manufacturing processes must be conveyed to Kampi.
MANUFACTURING PLANS. The Parties, through the Supply Chain Sub-Committee, will agree upon the VEGF Product manufacturing plan (the “Manufacturing Plan”) providing for Regeneron’s manufacture and supply of Clinical Supply Requirements in accordance with Section 8.2 and Aventis’ manufacture and supply in accordance with Section 8.3. In addition, the Manufacturing Plan shall reflect the Parties’ intention to use Commercially Reasonable Efforts to minimize Manufacturing Cost for each VEGF Product. The Supply Chain Sub-Committee will prepare and update the Manufacturing Plan coordinating the entire supply chain to support all VEGF Product needs and coordinate with the Joint Development Committee to prepare associated regulatory strategy and procedures. The initial Manufacturing Plan is annexed hereto as Schedule 7. The Parties shall use Commercially Reasonable Efforts to perform their responsibilities in accordance with the Manufacturing Plans. The Manufacturing Plan shall include plans for appropriate back-up manufacturing facilities and inventory levels typically maintained to prevent any interruption, discontinuity or other impediment to continued supply of VEGF Products.
MANUFACTURING PLANS. BNFL shall prepare manufacturing plans or process outlines which identify the manufacturing sequence, and Quality Control Plans or Inspection Schedules as the case may be in support of the Contract Specification identified in Appendix 3 of this Agreement. These manufacturing plans or process outlines shall be submitted to BEG(UK) for information and the said Quality Control Plans or Inspection Schedules shall be made available to BEG(UK) at Springfields.
MANUFACTURING PLANS. 56 6.3 Designation of Lead Manufacturing Party........................................................56 6.4 Standard Cost of Goods Sold....................................................................58 6.5 Quality Manual.................................................................................58 ARTICLE 7 COMMERCIALIZATION PROGRAM......................................................................59 7.1 Joint Commercialization Committee..............................................................59
MANUFACTURING PLANS. The JMC will develop a manufacturing plan (a) to ensure continuity and adequacy of supply of the active pharmaceutical ingredient and bulk drug product dosage form of each Product Class of Licensed Products for the Profit-Share Territory (and whether such Licensed Product will be supplied by Sage or by Biogen (if both Parties will be Manufacturing)) and, for so long as [**] is the Manufacturing Lead Party, for the [**] and (b) for final packaging and labeling in the Profit-Share Territory, which plan will also include the estimated associated budget of FTE Costs and Out-of-Pocket Costs anticipated to be incurred in the performance of activities under such plan (such included budget, a “Manufacturing Budget”), and the JMC will submit such manufacturing plan to the JSC to
MANUFACTURING PLANS. With respect to all Collaboration Products that Organon or its Affiliated Subcontractor(s) Manufactures pursuant to this Article 7, Organon shall be responsible for implementing all aspects of Manufacturing necessary for Development under the direction and oversight of the Joint Management Committee, as set forth in Section 3.4, and in accordance with a manufacturing plan for the applicable Collaboration Product(s) in the Collaboration Field proposed by Organon and subject to review and approval by the Joint Management Committee, which manufacturing plan shall describe the specific Manufacturing activities to be undertaken by Organon, shall include a general description of the personnel and other resources to be used in the implementation thereof and shall set forth a unanimously agreed budget for such activities (each, as may be modified or amended and approved from time to time in accordance with this Agreement, a "Manufacturing Plan").
MANUFACTURING PLANS. 47 SECTION 9.04.