Commercial Manufacture definition

Commercial Manufacture means methods and processes used by or on behalf of a Party for producing, processing, extracting or isolating Transgenic Oil for Commercial Sale.

Commercial Manufacture has the meaning set forth in the MDSA.

Commercial Manufacture means Manufacture for commercial sale, including (a) reservation of Manufacturing capacity for use in Manufacture for commercial sale; (b) selection and use of contract manufacturers; (c) selection of the Commercial Facilities; (d) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (e) conduct of process performance qualification batches and other process qualification and validation activities required for Regulatory Approval for Commercial Manufacture of Collaboration Product at the Commercial Facility(ies); and (f) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.

Examples of Commercial Manufacture in a sentence

• Zogenix shall effect the commercial launch of the Product in the Territory within [***] ([***]) days of the Regulatory Approval, provided sufficient quantities of commercial Product are available pursuant to the Commercial Manufacture and Supply Agreement.

• Subject to the terms of this Agreement and the terms of the Commercial Manufacture and Supply Agreement, Elan hereby grants to Zogenix a non-exclusive license under the Elan Intellectual Property to make or have made the Product in the Field in the Territory (the “Manufacturing License”), which Zogenix shall not be entitled to utilize except where there is a Failure to Supply.

• The Parties agree that they, or an Affiliate, will negotiate in good faith a Commercial Manufacture and Supply Agreement for the commercial supply of Product in the Territory.

• Where Elan (or its Affiliate) remedies the cause of the Failure to Supply and is once again able to fulfil its obligations to supply the Product, Elan (or its Affiliate) shall so notify Zogenix and Zogenix shall cease manufacturing the Product and shall resume purchasing the Product exclusively from Elan pursuant to the terms of the Commercial Manufacture and Supply Agreement; provided that [***].

• The Parties further agree that the Commercial Manufacture and Supply Agreement shall incorporate the terms set out in Clause 9 and Schedule 2 of this Agreement, together with other customary terms for commercial supply of pharmaceutical products containing Controlled Substances.

More Definitions of Commercial Manufacture

Commercial Manufacture shall have a correlative meaning.

Commercial Manufacture means all activities relating to supply of Licensed Product for Phase 3b Studies and Phase 4 Studies and for all commercial supply of API Compound and Licensed Product after THERAVANCE’s delivery of the First Commercial Sale Stock. This includes without limitation formulation, fill, finish, QA, QC, and all analytical methods development.

Commercial Manufacture means Manufacture for commercial sale, including use of contract manufacturers for such commercial sale, and the following activities, whenever required during the Term for a given Collaboration Product (a) selection of the facility(ies) for commercial Manufacturing of Collaboration Product (including for pivotal trials) (“Commercial Facilities”); (b) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (c) conduct of process performance qualification (“PPQ”) batches and other process qualification and validation activities required for Regulatory Approval for commercial Manufacturing of Collaboration Product at the Commercial Facility(ies); and (d) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities. “Control” means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, as provided herein, without violating the terms of any agreement or other arrangement with any Third Party, or any applicable law. “Development” means all activities related to research, pre- clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance/quality control, clinical trials, including manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of applications for marketing approval, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a regulatory authority as a condition or in support of obtaining or maintaining a regulatory approval. When used as a verb, “Develop” means to engage in Development.

Commercial Manufacture means the manufacture and production by defendant B-D, in its normal and regular course of business, of hypodermic syringes which it regularly sells or offers for sale. The term “commercial manufacture” as used herein does not include exclusively experimental manufacture;

Commercial Manufacture means Manufacture for commercial sale, including use of contract manufacturers for such commercial sale, and the following activities, whenever required during the Term for a given Collaboration Product (a) selection of the facility(ies) for commercial Manufacturing of Collaboration Product (including for pivotal trials) (“Commercial Facilities”); (b) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (c) conduct of process performance qualification (“PPQ”) batches and other process qualification and validation activities required for Regulatory Approval for commercial Manufacturing of Collaboration Product at the Commercial Facility(ies); and (d) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.

Commercial Manufacture means the Manufacture of a Licensed Product (including Manufacturing the Licensed Compound contained in such Licensed Product) or acquisition of such Licensed Compound and Licensed Product from a CMO, in each case, for Commercialization of such Licensed Product.

Commercial Manufacture means the manufacture of a Lead Candidate for the purpose of commercial sale of such Lead Candidate, whether in its technical form or in a product formulation.