Common use of IND Data Package Clause in Contracts

IND Data Package. Within [***] ([***]) days after Filing of the first IND with the FDA for a Lead Candidate from a given Program ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the IND Data Package for such Program (which, for clarity, shall specify all then-existing Lead Candidates from such Program). If Celgene designates a Third Party advisor to receive the IND Data Package, such Third Party advisor shall, prior to receiving such IND Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete IND Data Package, Celgene (or its designee) shall review such IND Data Package, and Celgene (or its designee) shall notify Prothena, no later than [***] ([***]) days after receiving such IND Data Package, of [***]. If [***], the IND Option Term with respect to such Program shall [***].

Appears in 2 contracts

Sources: Master Collaboration Agreement (Prothena Corp PLC), Master Collaboration Agreement (Prothena Corp PLC)