Development and Manufacture Clause Samples

The 'Development and Manufacture' clause outlines the responsibilities and procedures related to the creation and production of a product or technology under an agreement. It typically specifies which party is responsible for research, design, prototyping, and scaling up to full manufacturing, as well as any quality standards or regulatory requirements that must be met. This clause ensures that both parties have a clear understanding of their roles and expectations in bringing a product from concept to market, thereby reducing misunderstandings and facilitating efficient collaboration.
Development and Manufacture. Cordis will perform Development Services, manufacture, and sell the Product to SRM in conformance with the Specifications, QS, Applicable Laws and otherwise in accordance with the terms and conditions of this Agreement and the License Agreement,
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Development and Manufacture. Subject to the terms and conditions of this Agreement, Siemens hereby grants to UBI a non-exclusive, worldwide, royalty-free license, without the right to sublicense, under the Siemens Background IP and the Siemens Collaboration IP, solely (i) to perform the Development Work, and (ii) to make and have made Strip Products on Siemens’ behalf pursuant to the Supply Agreements.
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Development and Manufacture. Upon exercise of the Option by Company in accordance with Sections 3.1.2 and 5.2, Company shall use the Licensed IP solely for the purpose of researching, Developing, manufacturing and Commercializing the Products in the Field in accordance with this Agreement, and Company, its Affiliates and Sublicensees, as applicable, shall bear all costs and expenses for the foregoing. Company shall determine the pricing for all Products at its sole discretion, provided, however, that Company shall not sell any Product as a loss leader (i.e., at a price below its market cost to stimulate other sales of more profitable products or services). Company covenants that it shall not use any of the Licensed IP to carry out any activity or exercise any right other than those expressly licensed by to Company pursuant to this Agreement. Company shall have the right and responsibility, at its sole expense, to conduct and control the filing of any applications for Regulatory Approval for Products in the Field in the Territory, consistent with its obligations under this Agreement, and shall have sole responsibility for communicating with the Regulatory Authority in the Territory regarding any such Regulatory Approval. Notwithstanding the foregoing, the Company’s failure, at any time during the Term, to use Commercially Reasonable Efforts to Develop and Commercialize Products for a period continuing for at least [***], or abandonment of Development and Commercialization of Products, shall constitute a material breach of this Agreement. If Company is unable to cure such material breach pursuant to Section 9.2.1, the Commercial License provided in Section 3.1.3 shall be forfeited and revoked, and Company agrees to assign and hereby assigns as of the date of such failure or abandonment (as applicable) all of its rights, title and interest in and to the Licensed IP to Twist.
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Development and Manufacture. 3.1 Intellect shall be solely responsible for all development of the Antibodies, including all pre-clinical and clinical development activities. Intellect (and its Affiliates where appropriate) shall retain authority and responsibility for ensuring and maintaining compliance with applicable Laws. IBL and its Affiliates shall co-operate and provide to Intellect any assistance reasonably required by Intellect for the purposes of obtaining Regulatory Approvals for the Antibodies without further compensation, but with the understanding that reasonable expenses incurred by IBL and as are previously agreed to in writing by IBL and Intellect in connection therewith will be reimbursed by Intellect. IBL will make fully available to Intellect such of the IBL Technology as is necessary for Intellect to fully exploit the Antibodies consistent with this Agreement. 3.2 The Antibodies will be manufactured by Intellect or a Third Party manufacturer of Intellect’s sole choice.
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Development and Manufacture. (a) Samsung shall have sole responsibility for the Development of Compounds and Products, the Manufacturing of Compounds and Products, and all regulatory activities relating to the Development or Manufacturing of Compounds and Products, throughout the Territory. Samsung shall use Commercially Reasonable Efforts, at its own expense, to Develop and Manufacture each Product. As reasonably requested by Samsung, Merck shall provide clinical and/or regulatory input to Samsung with respect to Compound(s) or Product(s). Throughout the Territory, Samsung shall be the holder of the Marketing Authorizations for the Products; provided, however, that Merck shall be the holder of a Clone of Samsung’s Marketing Authorizations for the Products in the European Union (where applicable). (b) Notwithstanding anything to the contrary herein, [* * *]. [* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.]
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Development and Manufacture. After Aerin LLC approves a Licensed Product under Section 5.2, EL shall make commercially reasonable efforts to proceed with the completion of the development and commercial production of such Licensed Product and shall show, offer for sale, sell and ship such Licensed Product in a timely manner in accordance with industry standards. EL shall be responsible for designing and developing all Licensed Products, making samples and overseeing the production of Licensed Products, and EL shall bear all costs thereof.
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Development and Manufacture. As at the Effective Date, since the adoption of the Specification in Schedule 13.2(m), all Current IPH2201 produced by, to Innate’s knowledge, on behalf of Innate, has been, Manufactured, packaged, stored and labelled (as applicable) in accordance with all Applicable Laws and the Specification in Schedule 13.2(m).
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Development and Manufacture. Samsung shall have sole responsibility for the Development of Compounds and Products, the Manufacturing of Compounds and Products, and all regulatory activities relating to the Development or Manufacturing of Compounds and Products, throughout the Territory. Samsung shall use Commercially Reasonable Efforts, at its own expense, to Develop and Manufacture each Product. As reasonably requested by Samsung, Merck shall provide clinical and/or regulatory input to Samsung with respect to Compound(s) or Product(s). Throughout the Territory, Samsung shall be the holder of the Marketing Authorizations for the Products; provided, however, that Merck shall be the holder of a Clone of Samsung’s Marketing Authorizations for the Products in the European Union (where applicable).
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Development and Manufacture 
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Related to Development and Manufacture

  • 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).

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection ▇▇▇▇▇; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • 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.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • 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.