Designation application definition
Examples of Designation application in a sentence
Following the earlier of Phase I Completion and Biogen Idec’s assumption of activities under the BT Development Plan pursuant to Section 2.13(a), Sangamo will assign and transfer such IND and any Orphan Drug Designation application to Biogen Idec, who will thereafter be solely responsible for all clinical development, regulatory matters and commercialization of Licensed Products arising from the BT Program.
Promptly following any such submission, Sangamo shall provide to Biogen Idec final copies of all study reports and substantive written correspondence to any regulatory authority involving any such IND submission or Orphan Drug Designation application for a Licensed Product.