Supply and Quality Agreement definition

Supply and Quality Agreement has the meaning set forth in Section 6.5.
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Examples of Supply and Quality Agreement in a sentence

  • Under the Supply and Quality Agreement, the obligation to supply drug product shall have a term of five (5) years, which will automatically renew for succeeding five (5)-year terms and will include the price applicable pursuant to Section 6.5. In the event of any inconsistency between the Supply and Quality Agreement and Article 6 of this Agreement with regard to matters relating to supply, quality control and quality assurance, the terms of the Supply and Quality Agreement shall prevail.

  • The Supply and Quality Agreement will include the terms and conditions set forth on Exhibit K and contain such further customary and commercially reasonable terms governing similar supply arrangements and other terms as the Parties may agree, including appropriate forecasting and firm purchase order lead times, taking into consideration the reasonable notice requirements of FibroGen as well as any other terms set forth in this Article 6.

  • The initial Supply and Quality Agreement shall have a term of [ * ]) years for the supply of drug substance, after which AstraZeneca would have the right to extend the term for an additional [ * ] years or to assume responsibility for drug substance manufacture upon agreement of terms mutually agreed by the Parties, including [ * ] in the form of drug substance.

  • The initial Supply and Quality Agreement shall have a term of [*] years for the supply of drug substance, after which AstraZeneca would have the right to extend the term for an additional [*] years or to assume responsibility for drug substance manufacture upon agreement of terms mutually agreed by the Parties, including [*] in the form of drug substance.

  • If at any time FibroGen’s net margin percentage on any Product supplied to AstraZeneca falls below [ * ]) after a Generic Product is sold in any country in the Territory, FibroGen shall have the right to renegotiate the manufacturing and supply payment terms under the Supply and Quality Agreement.

  • If, after Option Exercise, Novartis notifies Akcea that Novartis wishes to acquire additional API, the Parties will discuss in good faith and endeavor to mutually agree through the JDCC on the quantity and timelines for the supply of any such additional API on terms and conditions as set forth in Schedule 1.3.1. If required, the Parties shall negotiate in good faith the terms and conditions of a Supply and Quality Agreement.

Related to Supply and Quality Agreement

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Xxxxxx Agreement means that certain Contingent Stock Agreement, effective as of January 1, 1996, by The Xxxxx Company in favor of and for the benefit of the Holders (named in Schedule I thereto) and the Representatives (therein defined), as amended.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • the first supplementary agreement means the agreement of which a copy is set out in the Second Schedule;

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • Omnibus Agreement means that certain Omnibus Agreement, dated as of the Closing Date, among the General Partner, the Partnership, the Operating Company and certain other parties thereto, as such may be amended, supplemented or restated from time to time.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Commercial Supply Agreement has the meaning set forth in Section 4.1 (Supply Agreement).

  • Acquisition Agreement Representations means the representations and warranties with respect to the Companies made by the Seller in the Acquisition Agreement to the extent a breach of such representations and warranties is material to the interests of the Lenders, but only to the extent that the Borrower or its Affiliates have the right to terminate its or their obligations under the Acquisition Agreement (or decline to consummate the Rockwood Acquisition) as a result of a breach of such representations in the Acquisition Agreement.

  • Transportation Agreement means an agreement pursuant to the Tariff under which Transporter provides Transportation or other contract services to a Shipper.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Technology License Agreement means the Technology License Agreement dated as of the date hereof between Allergan and ASTI.

  • SCM Agreement means the Agreement on Subsidies and Countervailing Measures in Annex 1A to the WTO Agreement;

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Original Agreement has the meaning set forth in the recitals.

  • License Agreement means the agreement between SAP (or an SAP SE Affiliate, or an authorized reseller) under which Customer procured the rights to use SAP Software or a Cloud Service.

  • Services Agreement means an agreement entered into between a Utility and one or more Affiliates for the provision of Shared Services or For Profit Affiliate Services and shall provide for the following matters as appropriate in the circumstances:

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Commercial Agreement means an agreement, other than an agency agreement, made between carriers and relating to the provision of their joint services for carriage of passengers by air;

  • High Quality Waters means all state waters, except:

  • Basic gas supply service means gas supply service that is

  • Cross License Agreement means that certain Cross License Agreement between and among Medarex, Cell Genesys, Inc., Abgenix, Inc., Xenotech, L.P. and Japan Tobacco Inc., dated March 26, 1997.

  • Compliance agreement means a written agreement between a person and the Commissioner to achieve compliance with this quarantine.

  • Transportation Service Agreement means the contract between KUB and the Customer whereby KUB agrees to provide transportation gas service to the Customer.

  • Assistance Agreement means a for- mal, written agreement between the CDFI Fund and an Awardee which specifies the terms and conditions of assistance under this part;