Common use of Xxxxx 0 and Post-Approval Clinical Supply Clause in Contracts

Xxxxx 0 and Post-Approval Clinical Supply. Celgene shall Manufacture and supply all Clinical Supplies for Phase 3 Clinical Trials and Post-Approval Clinical Trials; provided, however, that the Joint Development Committee may request, at least one (1) year prior to the anticipated launch of the first Phase 3 Clinical Trial or Post-Approval Clinical Trials, as applicable, that Acceleron Manufacture and supply such Clinical Supplies on terms to be agreed. 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 or Post-Approval Clinical Trials, and otherwise the Costs of Clinical Supplies shall be allocated in accordance with Article 5, including Section 5.5. 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 Xxxxx 0 Clinical Trials, Phase 2A Clinical Trials, or Phase 2B 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 2.4.2.