Deviation Request. During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines. This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.
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Sources: Contract (Gritstone Bio, Inc.), Contract (Spero Therapeutics, Inc.)
Deviation Request. During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBRactivities, the Contractor contractor shall submit a Deviation Report. This report shall request a change in the agreed-agreed upon IMS and timelines. This report shall include: (i) discussion of the justificationrationale/rationale justification for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-cost- benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.
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