Review of Correspondence. To the extent practicable, Celgene shall provide Acceleron with drafts of any documents or other correspondence to be submitted (i) to the applicable Regulatory Authorities in North America, (ii) to Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in each case, pertaining to each Licensed Compound or Licensed Product, sufficiently in advance of submission for Acceleron to review any such submission, and Acceleron may comment on such documents to the extent that they are intended to be submitted (i) to the applicable Regulatory Authorities in North America, (ii) to Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in which case Celgene shall consider in good faith all such comments. Celgene shall provide to Acceleron, as soon as reasonably practicable, copies of any documents or other correspondence received (i) from Regulatory Authorities in North America, (ii) from Regulatory Authorities outside North America if for the purpose of obtaining Regulatory Approval in North America, or (iii) in connection with any Acceleron Development Activity, in each case, pertaining to each Licensed Compound or Licensed Product (including any meeting minutes).
Appears in 4 contracts
Samples: License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc), Collaboration, License and Option Agreement (Acceleron Pharma Inc)