Clinical Supply definition

Clinical Supply. Agreements shall have the meaning set forth in Section 8.1.

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Clinical Supply has the meaning set forth in Section 5.1.

Clinical Supply or “Clinical Supplies” means finished Drug Product for use in Clinical Trials.

Examples of Clinical Supply in a sentence

• Nothing in the foregoing sentence shall be deemed to affect the definition of Manufacturing Cost and/or any right that Ipsen specifically is provided or granted under this Agreement to charge and collect from the other Party the Manufacturing Cost incurred by Ipsen in connection with Licensed Product supplied by such Party to the other Party under the terms and conditions of the Clinical Supply Agreements.

• Such Clinical Supply Agreement and quality agreement shall be entered into no later than [***] after the Effective Date (or such longer period of time as the Parties may agree), but in any event prior to the commencement of any activities relating to such supply, and the Parties will enter into specific statements of work for each Product Candidate and Elected Candidate, as additional Product Candidates and Elected Candidates are identified under this Agreement.

• The Clinical Supply Agreements will provide for the terms and conditions of the transfer of ▇▇▇▇▇’▇ manufacturing technology at the end of [ ]*, provided, however, that the Parties agree that such transfer will be made at Licensee’s cost and expense, less an amount equal to the ▇▇▇▇▇ Manufacturing Transfer Cost, to be estimated and agreed by the parties in good faith.

• The Clinical Supply Agreement will contemplate a price of API and/or tablets which shall be no greater than Licensor’s cost of manufacturing such API or tablets.

• Regeneron shall provide the Regeneron Product to Sponsor in the form of unlabeled vials, and Sponsor shall be responsible for labeling, packaging and leafleting such Regeneron Product in accordance with the terms and conditions of the applicable Clinical Supply Quality Agreement and otherwise in accordance with all Applicable Law, including applicable cGMP, GCP, and health, safety and environmental protections.

More Definitions of Clinical Supply

Clinical Supply means the supply of requirements of Licensed Product and/or Compound for Clinical Trials under this Agreement.

Clinical Supply means the supply of “Product” by medac to ERYtech Pharma for the purpose of setting up clinical trials with GRASPA® anywhere in the world and sponsored by ERYtech Pharma in GRASPA® Indications as specified and agreed in Exhibit 3 to this Agreement.

Clinical Supply means, with respect to a Product, Product Manufactured for use in Development of such Product under this Agreement.

Clinical Supply means cGMP compliant Drug Product specifically produced and packaged for Clinical Studies for indications that are the subject of Regulatory Filings within the SPA Territory.

Clinical Supply means the quantities of Bulk Product that are required for Clinical Trials by a party or the parties to conduct preclinical studies and Clinical Trials Phase I-III in connection with the terms of the Development License and Commercialization Agreement.

Clinical Supply means, with respect to a Clinical IRD Product or ▇▇▇▇▇▇▇ Research IRD Product, such Product Manufactured for use in a Clinical Study of such Product under this Agreement.

Clinical Supply means Licensed Product for use in performing Development in the Field in the Territory pursuant to this Agreement, including for performing Phase IV Studies in the Field in the Territory.