definiens: means ( i ) with respect to Product sold in Calendar Year 2008 or 2009, that certain amount to be used as the cost of goods for purposes of this Agreement for such period per one ( 1 ) gram vial of Product or per five hundred ( 500 ) milligram vial, as applicable, as such amount was specified in that certain letter dated as of June 30,2008 provided by [COMPANY] to [COMPANY] on the Effective Date, or ( ii ) with respect to each Calendar Year commencing with Calendar Year 2010, the standard cost of goods for the Product for such Calendar Year, as such standard cost of goods is established by [COMPANY] in accordance with its standard operating procedures, which standard cost shall be [COMPANY] 's good faith estimateof(A ) [COMPANY] 's and its Affiliates ' direct cost of transport, labor, services and materials relating to such supply, ( B ) all of [COMPANY] 's and its Affiliates ' properly allocable overhead relating to such supply ( but excluding corporate, administrative and all other overhead not relating to the Product in the Territory ), and ( C ) payments by [COMPANY] 9 ' Confidential Treatment Requested . Omitted portions filed separately with the Commission . Execution Copy and its Affiliates to any Third Party manufacturer for manufacture, filling, finishing, packaging, labeling, testing, storage and distribution of the Product, as all of the foregoing are determined and allocated in accordance with International Accounting Standards ] *