MANUFACTURING PLANS. The Supplier is responsible for maintaining documented records of the manufacturing processes, steps, sequences, verifications, and qualifications. Xxxxxx 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 [*].
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. 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 for information and the said Quality Control Plans or Inspection Schedules shall be made available to BEG at Springfields.
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. 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. 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 review, discuss and determine whether to approve (each, a “Manufacturing Plan”). The initial Manufacturing Plans for the Licensed 217 Products and the Licensed 324 Products will be approved by the JSC no later than [**] after the Effective Date. On an annual basis no later than [**] of each Calendar Year, or more often as the Parties deem appropriate, the Parties, through the JMC, may prepare and approve amendments to the then-current Manufacturing Plans for each Product Class and will submit such amendments to the JSC to review, discuss and determine whether to approve. Each such amended Manufacturing Plan will specify the information described in this Section 7.2 (Manufacturing Plans) for the next Calendar Year (and additional periods as reasonably determined by the Parties) and the Manufacturing Budget included therein will appropriately itemize the costs and expenses for the activities undertaken pursuant to such Manufacturing Plan. Once approved by the JSC, an amended Manufacturing Plan (including its corresponding Manufacturing Budget) will become effective and supersede the previous Manufacturing Plan (including its corresponding Manufacturing Budget). In the event of any inconsistency between the Manufacturing Plan and this Agreement, the terms of this Agreement will prevail.
MANUFACTURING PLANS. The Parties, through the JSC, will develop and update as necessary, the Licensed Product Manufacturing plan (the “Manufacturing Plan”) providing for the Manufacturing (including testing and specifications), distribution, and forecasting of Clinical Supply Requirements under the Development Plans and Commercial Supply Requirements under the Territory Commercialization Plan, including, if applicable, the choice of Third Party manufacturers, fillers, packagers, and labelers. However, Regeneron will have the right to make all decisions with respect to Manufacturing Formulated Bulk Product for Regeneron Products, subject to Company’s prior written approval, such approval not to be unreasonably withheld or delayed. Each Manufacturing Plan shall set forth the Licensed Product requirements over an ensuing period of at least three (3) Contract Years. The Manufacturing Plan will include [******************************************]. The Manufacturing Plan (including each annual update thereto) shall be approved by the JSC at least two (2) months prior to the end of the then current Contract Year, except that the initial Manufacturing Plan shall be approved by the JSC within four (4) months after the Effective Date. The Parties shall design Manufacturing Plans to ensure an adequate supply of Licensed Product and shall use Commercially Reasonable Efforts to perform their responsibilities in accordance with the approved Manufacturing Plans.
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
