Phase 1 Data Package. If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program. If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***]. If [***], the Phase 1 Option Term with respect to such Program shall [***]. For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
Appears in 2 contracts
Sources: Master Collaboration Agreement (Prothena Corp PLC), Master Collaboration Agreement (Prothena Corp PLC)
Phase 1 Data Package. If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program. If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***]. If [***], the Phase 1 Option Term with respect to such Program shall [***]. For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
Appears in 1 contract
Sources: Master Collaboration Agreement