Development and Manufacture of Product Clause Samples

The 'Development and Manufacture of Product' clause defines the responsibilities and procedures for creating and producing a specified product under the agreement. It typically outlines which party is responsible for research, design, testing, and scaling up to commercial manufacturing, as well as the standards and timelines that must be met. This clause ensures that both parties have a clear understanding of their roles and expectations, reducing the risk of disputes and delays in bringing the product to market.
Development and Manufacture of Product. 5.1 Resources; Applicable Law. Manufacturer will comply with all Applicable Law in performing Services.
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Development and Manufacture of Product. 5.1 Piramal will perform all Services at the Facility, and will hold at the Facility all Equipment, Bolt Materials and other items used in the Services. Piramal may change the location of the Facility or use any additional facility for the performance of Services by providing Bolt at least [***] prior written notice, and receiving Bolt’s prior written consent, [***]. The Parties agree that [***]. Piramal will maintain the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating ·efficiency consistent with the requirements of cGMP, the applicable Statement of Work and Applicable Law. 5.2 The scope of Services under a Statement of Work may be changed only through a written change order signed by both Parties (“Change Order”) in substantially the form attached hereto as Exhibit 2. If a change to a Statement of Work is identified by a Party, that Party will notify the other Party as soon as is reasonably possible. Piramal will provide Bolt with a Change Order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Statement of Work within approximately [***] of receiving or providing such notice. If the Change Order is not acceptable to Bolt, the Parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Piramal will continue to work under the existing Statement(s) of Work during any such negotiations but will not commence work in accordance with the Change Order until it is authorized in writing by Bolt. Should Bolt request (in writing by Bolt’s primary Technical Contact or its Chief Business Officer) Piramal to perform additional services without there being a valid Change Order in place, Bolt shall be liable for the costs of such additional services at commercial rates consistent with the original Statement of Work. 5.3 Any change or modification to the Manufacturing Process or Specifications for any Product must be approved in writing in advance by Bolt and will be made in accordance with the provisions of the Quality Agreement. 5.4 Piramal will take and retain, for such period and in such quantities as may be required by cGMP and the Quality Agreement, samples of Product produced using the Manufacturing Process developed under this Agreement. 5.5 Piramal will keep complete and accurate original records (or certified copies thereof), including, without limitation, reports, accounts, notes, data, and...
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Development and Manufacture of Product 
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Related to Development and Manufacture of Product

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • 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).

  • 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.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • Manufacture 2.1. The LED(s) on the LED module shall be equipped with suitable fixation elements. 2.2. The fixation elements shall be strong and firmly secured to the LED(s) and the LED module.