definiens: means all Out - of - Pocket Costs and FTE Costs incur red by or on behalf of a Party or its Affiliates in connection with the research and Deve lopment of the Product in accordance with the appli cable approved Development Plan and Budget, in accordance with the expense recognition provisions of the GAAP, includ ing, without limitation, the costs of preclinical testing, toxic ology, formulation, clinical trials, the preparatio n, collection and/or validation of Data from such clinical trials and the preparati on of medical writing and publishing on the Data an d results obtained from such clinical trials, market research with respect to Development, in each case to the extent that suc h activities, Out - of - Pocket Costs and FTE Costs are within the scope of the Dev elopment Plan and Budget . For purposes of the prece ding sentence, costs shall be deemed to be incurred in accordance with a n applicable approved Development Plan and Budget i f they were incurred in the performance of the activities specified in t he Development Plan and Budget and do not exceed by more than ten percent ( 10 % ) the amount budgeted in the Development Plan a nd Budget for such activities ( unless such overage has been approved by the other Party, which approval shall not be unreas onably withheld to the extent the incurrence of suc h excess costs was not within the reasonable control of the Party who incu rred such excess costs ) . Development Costs shall no t include any ( i ) costs incurred by [COMPANY] prior to the Effective Date, or ( ii ) Out - of - Pocket Costs committed to by [COMPANY] prior to the Effective Date ; provided, however, that notwithstanding the foregoi ng, ( a ) the amounts to be paid to [COMPANY] as set fort h in Section 9.1.2 representing 100 % of the Fully Burdened Manufacturi ng Cost for Existing Quantities of Product shall be included within the POC Development Costs, and ( b ) Out - of - Pocket Paymen ts for the manufacture or supply of Products from a nd after the Effective Date, or for the conduct of data analysis or sample analysis in connection with Development activities conducted after the Effective Date, in each case that are oth erwise within the definition of Development Costs, shall be included within Development Costs regardless of whether such Out - of -Pocket Payments are made pursuant to an agreement in effect prior to the Effective Date . Payments to support investigato r - sponsored trials of the Product at the 5 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omit ted and filed separately with the Securities and Exchange Commiss ion pursuant to Rule 24b-2 of the Securities Exchan ge Act of 1934, as amended