Workplan Contents. The goal of the Workplan and the Program will be to evaluate and produce LNP formulations that are safe and efficacious for delivery of Verve’s Genome Editing Constructs and to advance the development of such RNA-LNP formulations as therapeutic drug candidates. All activities using Acuitas LNP Technology will be limited to Reserved Targets and will be only as set forth in the Workplan. The Workplan will include (i) all activities to be undertaken by each Party with respect to the Program, including Acuitas’ manufacture and supply of Formulated Product at scales and quality sufficient for preclinical non-human primate testing and pilot scale manufacturing, (ii) a detailed budget of the FTE activities, FTE Costs and out-of-pocket costs to be incurred by Acuitas for which Verve will reimburse Acuitas in connection with the performance of the Works and Services, (iii) the Materials to be provided by one Party to the other Party, (iv) the specifications, quantity and delivery date for the Formulated Product to be manufactured and supplied by Acuitas, and (v) the projected timelines for completion of all activities set forth therein. The Workplan will be comprehensive and include all activities using the Acuitas LNP Technology by both Parties commencing after the Effective Date, including any preclinical or other activities outsourced to Third Parties, to be undertaken prior to Verve exercising an Option for a Non-Exclusive License Agreement. No Acuitas LNP Technology or Formulated Product will be used by Verve outside of the Workplan prior to Verve exercising an Option for a Non-Exclusive License Agreement and then only to the extent permitted under the Non-Exclusive License Agreement.
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Sources: Development and Option Agreement (Verve Therapeutics, Inc.), Development and Option Agreement (Verve Therapeutics, Inc.)