Common use of Separate Programs Clause in Contracts

Separate Programs. Prior to the earlier of (i) [***] or (ii) [***], if Vividion reasonably believes that [***] Program Compounds in such Program would be approved under different product labels for distinct Indications if such Program Compounds were to receive Regulatory Approval in the United States (based upon distinct substantiating evidence obtained from Functional Phenotypic Assay Similarity Criteria results for each such Program Compound demonstrating utility in distinct Indications where one Program Compound could not be substituted by another Program Compound for such distinct Indication(s)), then Vividion may deliver written notice thereof to Celgene and thereafter the Parties shall discuss in good faith for a period of [***] days whether or not such Program should be split into [***] separate Programs (with each such Program Compound assigned to a distinct separate Program) (each, a “Separate Program”). If Celgene does not agree in writing within such [***] day period that such Program should be split into [***] Separate Programs, then Vividion shall have the right to submit such Program Compounds to the independent evaluation described in Section 2.3.4(c) to determine or confirm based upon then-current good scientific practice and understanding, data generated, and the proposed discovery and development research plan with respect to the applicable Program, whether or not each such Program Compound in such Program would be approved under different product labels with distinct Indications if such Program Compounds were to receive Regulatory Approval in the United States. If so agreed upon by Celgene or determined or confirmed under Section 2.3.4(c), then such Program shall be split into [***] Separate Programs (with each applicable Program Compound assigned to a distinct Separate Program), notwithstanding that each such Program Compound is Directed against the same Program Target. After the earlier of (i) [***] or (ii) [***], where Vividion reasonably believes [***] Products were Developed under such Program, such determination shall no longer be subject to the “Separate Program” determination set forth in this Section 2.3.4(b) and will instead be subject solely to the “Distinct Product” determination mechanism provided in Section 2.3.4(a).

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.), Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.)