Manufacturing Activities definition
Manufacturing Activities means those activities performed by a party relating to the manufacture and supply of Alnylam Royalty Products.
Manufacturing Activities means those activities associated with the production, manufacture or processing of Licensed Vaccines and/or Licensed Products, and the filling, finishing, packaging, labeling, shipping and storage of such Licensed Products, including without limitation quality assurance and quality control, that are performed by GlobeImmune, its Affiliates or contractors under this Agreement, the Supply Agreement or any quality agreement relating to the manufacture or supply of Licensed Vaccines and/or Licensed Products.
Manufacturing Activities means the manufacturing, processing, testing, analytical, packaging, transport, handling, use, storage and other activities undertaken or required to be undertaken by Supplier or its suppliers or subcontractors in order to manufacture and supply Buyer with the Product meeting the Product Specifications.
Examples of Manufacturing Activities in a sentence
In the event that the results of such audit reveal any deficiencies or other areas of remediation pursuant to GxP and Applicable Law with respect to Viridian’s Manufacturing Activities for Licensed Product to be used for Clinical Development or Commercialization in the Territory, then Kissei will notify Viridian in writing of the foregoing, [***].
In the event that the results of such audit reveal any deficiencies or other areas of remediation pursuant to GxP and Applicable Law with respect to Kissei’s (or its Affiliate’s, Subcontractor’s, or Sublicensee’s, as applicable) Manufacturing Activities, then Viridian will notify Kissei in writing of the foregoing, and [***].
More Definitions of Manufacturing Activities
Manufacturing Activities means, with respect to a Product, all activities involved in the production, storing, handling, packaging, labeling and distribution of Product to be Developed or Commercialized under this Agreement. Such Manufacturing Activities may include: (a) creation and design of the Product packaging; (b) the creation and implementation of a commercial inventory and Product supply chain distribution strategy; (c) the manufacture of clinical and commercial inventory for the Product; (d) the manufacture of a delivery device for the Product; (e) the manufacture of the packaging for the Product; (f) quality control and quality assurance of the Product; (g) release of the Product; and (h) the distribution, delivery and storage of the Product. For avoidance of doubt, (a) through (h) above sets forth examples of activities that would constitute “Manufacturing Activities” rather than a list of activities required to be performed by a Party. The Manufacturing Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Product Work Plan.
Manufacturing Activities means the development of manufacturing processes for, and the manufacture and supply (including formulation, filling, finishing, packaging, labeling, quality control, quality assurance testing and release, shipping, handling, storing and warehousing, as applicable) of, active pharmaceutical ingredient, bulk drug substance, drug product or placebos to support Development or Commercialization of the Licensed Compound or Licensed Product, as the case may be, including such manufacturing activities conducted for purposes of producing clinical supplies (or materials used in preclinical testing or research), manufacturing process development, scale-up and validation of manufacturing prior to Regulatory Approval, and manufacture and supply of commercial quantities of Licensed Product.
Manufacturing Activities of a Party means those activities performed by such Party under the Manufacturing Plan, the Supply Agreement, and/or the Quality Agreements relating to the Manufacture and supply of Alnylam Royalty Products.
Manufacturing Activities means production by FRESENIUS of Product for regular sale by COMPANY.
Manufacturing Activities. “Manufacture”, “Manufactured”, or “Manufacturing” means any steps, processes and activities necessary for production by FRESENIUS of Product including the manufacturing, processing, packaging, labelling, quality control testing, stability testing, release, storage or supply of Product as required by the applicable Product Schedule, this Agreement, the MBR, and the applicable Quality Agreement.
Manufacturing Activities means: the manufacturing activities to be provided by SYNCO in the Manufacturing Phase in accordance with this Agreement, and as described in the applicable Service Specific Addendum.
Manufacturing Activities means the activities and operations to be undertaken by each Party depending on the context (or its respective designees, including third party manufacturers and subcontractors), in the manufacture (including embryonation), quality control testing (including in-process, release and stability testing when applicable), and release of Product to meet the Specifications, and supply of clinical and commercial quantities of Product in accordance with Regulatory Standards.