Manufacture definition
Examples of Manufacture in a sentence
At any time following completion of an Initial Study but prior to ninety (90) days before ▇▇▇▇’s first patient dosed in a subsequent Clinical Trial with respect to a Collaboration Product, Entera may upon written notice to OPKO (an “Opt-Out Notice”) elect to no longer participate in the sharing of costs with respect to further Development, Commercialization, and Manufacture of such Collaboration Product (such election, an “Opt-Out”).
Subject to the terms of this Agreement, with respect to each Licensed Program and corresponding Licensed Compounds and Licensed Products, Novartis will, at its cost and expense, have the exclusive right to Manufacture (including having a Third Party Manufacture on its behalf) such Licensed Compounds and Licensed Products (including all such Manufacturing for use in Clinical Trials and for Commercialization).
Amgen will, and will require its Affiliates and Sublicensees to, comply with all Applicable Law in its and their Research, Development, Manufacture and Commercialization of Collaboration Proteins and Licensed Products, including where appropriate GMP, GCP and GLP (or similar standards).
Unless otherwise agreed by the Parties (e.g., as set forth in the applicable Development Plan), for any quantities of Collaboration Product to be used for subsequent Development Activities under an Oral Product Research and Development Plan or for Commercialization, and subject to the successful completion of the Manufacturing technology transfer described below, OPKO will be responsible for the Manufacture of Collaboration Product (in both drug substance and drug product form).
In addition, OPKO may subcontract to Third Parties the performance of tasks and obligations with respect to the Development, Manufacture and Commercialization of a Collaboration Product in the Field as OPKO deems appropriate, subject to Section 4.5 in relation to Development Activities.