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

  • If required, the Parties shall negotiate in good faith the terms and conditions of a Supply and Quality Agreement.

  • 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 Commercial Supply and Quality Agreement shall include the binding terms detailed in Schedule 4.2. Within twenty (20) calendar days after the Effective Date and during the Term Acer shall promptly share with Relief a copy of the agreements in force with any Third Party CDMC and any amendment thereof.

  • 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.

  • The terms of any such Supply and Quality Agreement, including the Manufacturing Party’s and the Non-Manufacturing Party’s respective rights and obligations under such Supply and Quality Agreement, shall be consistent with, and limited by, rights and obligations of the Manufacturing Party under any applicable CMO Supply Agreements.

  • 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 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.

  • Such supply will be subject to a separate Clinical Supply and Quality Agreement (the “Clinical Supply and Quality Agreement”) to be negotiated in good faith (based on Acer’s agreements with Third Party CDMCs for the manufacture and supply of Acer Product) promptly following the Effective Date.

  • With respect to any transition of the manufacturing of Amgen Products (the “Transitioned Manufacturing”) to an alternate source pursuant to Section 5.1 (Supply and Quality Agreement) or Section 5.1.1 (Kite or Kite CMO Manufactures), Amgen and Kite shall cooperate to transition the Transitioned Manufacturing to Amgen (or to a mutually selected contract manufacturing organization the “Approved CMO”).

  • The Supply and Quality Agreement will concern supply by Emisphere of Program Carriers to Novo Nordisk to be used by Novo Nordisk in the continued toxicology studies and with an option for Novo Nordisk to have Emisphere supply Program Carriers for Novo Nordisk’s Phase 1 Clinical Trial.