Examples of Supply and Quality Agreement in a sentence
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.
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.
If required, the Parties shall negotiate in good faith the terms and conditions of a Supply and Quality Agreement.
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.
Any Product recall to be executed during the Term of this Agreement shall be managed by the Parties in accordance with the terms of the Clinical Supply and Quality Agreement and the Commercial Supply and Quality Agreement, as the case may be.
To the extent Amgen seeks to have a Third Party contract manufacturing organization perform manufacture of any Amgen Product after the period of Kite’s manufacture (itself or through the Kite CMO) of such Amgen Product under Section 5.1 (Supply and Quality Agreement) or Section 5.1.1 (Kite or Kite CMO Manufactures), it shall first inform Kite of such intent.
The Supply and Quality Agreement will contain terms and conditions that are reasonable and customary for agreements of such nature, including a right of the Non-Manufacturing Lead to include its Manufacturing Costs as Development Costs or Allowable Expenses, as applicable.
Thereafter, COGS will be calculated based on [*] as set forth in the Supply and Quality Agreement.