Common use of Manufacturing and Supply Clause in Contracts

Manufacturing and Supply. (a) For a period to be established by the JSC and agreed to by Ambit, such agreement not to be unreasonably withheld, which period is intended to support the orderly completion of the manufacturing technology transfer to Astellas to enable the First Commercial Sale in the Territory, Ambit shall continue to have primary operational responsibility for manufacturing and supply to Astellas of Clinical Trial supplies of the Lead Product (including manufacturing any intermediary or any Licensed Compound or other material contained therein for purpose of such supply), and all other activities in support of preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval necessary to support receipt of Regulatory Approval of the Lead Product in the Joint Development Territory. At and after the end of the foregoing period, Astellas shall have sole responsibility and decision making authority on (i) all manufacturing activities and regulatory activities designed to support preparation of the Chemistry, Manufacturing and Controls sections of any Regulatory Materials or Regulatory Approval, pharmaceutical process development (provided that such process development activities shall be overseen by the JSC), and (ii) manufacturing of Clinical Trial supplies and commercial manufacturing for the Lead Product and each other Product developed or commercialized under this Agreement (including any intermediate of any Licensed Compound or other material contained therein) in the Territory. For clarity, nothing in this Section 3.6.2 or any other term or condition of this Agreement is intended to or shall be construed to limit Astellas’s right and license, as provided in Section 3.1, to make and have made any Product (including any intermediary or any Licensed Compound or other material contained therein) at any time during the Term.