Common use of North American Responsibility Clause in Contracts

North American Responsibility. Celgene shall oversee, monitor, coordinate, file, and hold in its name all North American NDAs, all communications with and submissions to North American Regulatory Authorities and all North American Regulatory Approvals with respect to Licensed Compounds and Licensed Products. All costs associated with such activities will be shared by the Parties in accordance with Article 5, including Section 5.5. The Parties acknowledge that IND No. [* * *] has already been submitted to the FDA in Acceleron’s name. Upon completion of the Phase 2A Clinical Trials or earlier if necessary for a smooth transition to Celgene of Development responsibilities or otherwise requested by Celgene, Acceleron shall assign such IND to Celgene. If any INDs are filed in Acceleron’s name in connection with any Option Compound, such IND will be assigned to Celgene at such time, if any, as the Option Compound is deemed a “Licensed Compound” pursuant to Section 7.2. In addition, upon Celgene’s request, prior to completion of the Phase 2A Clinical Trials, Acceleron will be primarily responsible for all communications with and submissions to North American Regulatory Authorities and all North American Regulatory Approvals with respect to Licensed Compounds and Licensed Products, subject to Celgene’s review and approval.