definiens: with respect to Product means the costs incurred or accrued by the Parties with respect to work performed by the Parties or their respective Affiliates in accordance with the Development Plan in connection with the conduct of process and manufacturing development, development of Product and Regulatory Approvals and related activities including, but not limited to, data management, statistical designs and studies, document preparation and other expenses associated with the clinical testing program for Product, clinical grants, clinical laboratory fees, positive controls and the cost of studies conducted and services provided by contract research organizations and individuals, consultants, toxicology contractors, and manufacturers necessary or useful for the purpose of obtaining Regulatory Approvals for Product, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission of applications to obtain Regulatory Approvals for Product which costs are limited to, ( a ) direct, out - of - pocket external costs, ( b ) the Fully Absorbed Cost of Goods for batches of Product manufactured and supplied for use in pre - clinical and clinical trials and pre - commercialization activities and ( c ) work performed by [COMPANY] and [COMPANY] FfEs charged at the FfE Rate . All cost determinations made hereunder shall be made in accordance with GAAP