Phase 3 Clinical Supply Clause Samples

Phase 3 Clinical Supply. Celgene shall Manufacture and supply all Clinical Supplies for Phase 3 Clinical Trials and Post-Approval Clinical Trials; provided that (a) Celgene may request of Acceleron (or Acceleron may request of Celgene), at least one (1) year prior to the anticipated initiation of the first Phase 3 Clinical Trial for a Licensed Compound or Licensed Product, that Acceleron Manufacture and supply Clinical Supplies of such Licensed Compound or Licensed Product on terms to be agreed, which may include provisions related to the use of such material for launch and a portion of Commercial Supplies for a period thereafter on financial terms to be mutually agreed upon by the Parties. Acceleron shall not unreasonably refuse such request; provided that, notwithstanding any other provision of this Agreement, Celgene shall fully reimburse Acceleron for agreed upon capital expenditures reasonably required for Acceleron to Manufacture and supply such Clinical Supplies for Phase 3 Clinical Trials, and otherwise the Costs of Clinical Supplies shall be allocated in accordance with Article 5, including Section 5.5. (b) Within [* * *] of (i) a consummated Change of Control of Acceleron or (ii) the occurrence of any Triggering Event, Celgene, may, by written notice to Acceleron, assume responsibility for Manufacture and supply of all Clinical Supplies for all Clinical Trials (including all Phase 1 Clinical Trials and Phase 2 Clinical Trials) and upon such request, Celgene shall be responsible for the Manufacture and supply of such Clinical Supplies; provided that, if Acceleron fails to provide Celgene with written notice of such Change of Control or Triggering Event, such [* * *] period shall not commence until Acceleron provides such notice. Notwithstanding any other provision of this Agreement, Acceleron shall not be obligated to reimburse or share with Celgene any capital expenditures costs required for Celgene to Manufacture and supply Clinical Supplies for Phase 3 Clinical Trials or Post-Approval Clinical Trials. For purposes of clarification, upon transition of Manufacturing and supply obligations to Celgene pursuant to this Section 2.4.2 for a particular Licensed Compound or related Licensed Product, if any Clinical Supplies are needed for additional Phase 1 Clinical Trials or Phase 2 Clinical Trials for the same Licensed Compound or Licensed Product, such Manufacturing and supply responsibilities will be undertaken by Celgene in the same manner as set forth in this Section 2.4....