Common use of Technology Transfer to Contract Manufacturing Organization Clause in Contracts

Technology Transfer to Contract Manufacturing Organization. Prior to Verve’s exercise of an Option for a Licensed Product, Acuitas will be responsible for the RNA-LNP formulation, including analytical testing and documentation for all Licensed Products directed to Reserved Targets. Following the execution of a Non-Exclusive License Agreement, Acuitas will transfer all Know-How relating to the then-current formulation process for the manufacture of such Licensed Product to Verve or to a single contract manufacturing organization (a “CMO”) which will be determined by Verve (and reasonably acceptable to Acuitas). In the event the transfer of such Know-How is to a CMO the information will also be copied to Verve. For clarity, to be reasonably acceptable to Acuitas such proposed CMO must not be subject to a Deficiency. Acuitas will provide reasonable assistance to enable Verve or such CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by Verve and will be for the then current formulation of the Licensed Product. Specifically, in the event that Additional Development Studies for a Licensed Product are undertaken, Verve will notify Acuitas once a formulation is selected for technology transfer. Acuitas will be reimbursed for such activities by Verve on an FTE basis and Verve will also be responsible for all external costs incurred by Acuitas relating to transfer of the Licensed Product formulation to Verve or a GMP manufacturer provided such costs have been approved by Verve in advance. Once the Licensed Product formulation is transferred to Verve or the CMO, Verve will assume responsibilities for future manufacturing of Licensed Product. Acuitas will provide ongoing technical support if requested by Verve with such support reimbursed on a time, materials and FTE basis.

Appears in 2 contracts

Samples: Development and Option Agreement (Verve Therapeutics, Inc.), Development and Option Agreement (Verve Therapeutics, Inc.)

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Technology Transfer to Contract Manufacturing Organization. Prior to VerveOmega’s exercise of an Option for a Licensed Product, Acuitas will be responsible for the RNAGenome Modulating Construct-LNP formulation, including analytical testing and documentation for all Licensed Products directed to Reserved Targets. Following the completion of the Workplan for a Licensed Product and execution of a Non-Exclusive License Agreementagreement, Acuitas will promptly (and in any event within [***] ([***]) days following designation by Omega of the applicable GMP contract manufacturing organization (a “CMO”), provided such CMO is able to support this timeline) transfer all Know-How relating to the then-current formulation process process, raw materials supply, and analytical characterization for the manufacture of CERTAIN CONFIDENTIAL INFORMATION IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED such Licensed Product to Verve or to a single contract manufacturing organization (a “CMO”) which will be CMO determined by Verve (Omega and reasonably acceptable to Acuitas). In the event the transfer of such Know-How is to a CMO the information will also be copied to Verve. For clarity, to be reasonably acceptable to Acuitas such proposed CMO must not be subject to a Deficiency[***]. Acuitas will provide reasonable assistance to enable Verve or such the CMO to manufacture such Licensed Product. Initiation of such technology transfer will be determined by Verve Omega and will be for the then current formulation of the Licensed Product. SpecificallyFor clarity, in the event that Additional Development Studies for a Licensed Product are undertaken, Verve will notify Acuitas once a then current formulation is selected for technology transfer. Acuitas will be reimbursed for such activities by Verve on an FTE basis and Verve will also be responsible for all external costs incurred by Acuitas relating to transfer of the Licensed Product shall mean a single LNP formulation to Verve or a GMP manufacturer provided such costs have been approved previously tested by Verve Omega in advanceaccordance with the Workplan. Once the Licensed Product formulation is transferred to Verve or the CMO, Verve will assume responsibilities for future manufacturing of Licensed Product. Acuitas will provide ongoing technical support if requested by Verve with such support reimbursed on a time, materials and FTE basis[***].

Appears in 2 contracts

Samples: Development and Option Agreement (Omega Therapeutics, Inc.), Development and Option Agreement (Omega Therapeutics, Inc.)

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