definiens: means, with respect to an Optioned Product, the fu lly - burdened cost, including FTE costs at the FTE Rate and out - of - pocket costs incur red by Sanofi or its Affiliate in connection with manufacturing or purchasing from a Third Party, as applicable, Compounds and Products, in each case, o nly to the extent allocable to such manufacture, including ( x ) the costs associated with inventory build - up i n advance of the launch of Products in the United States, but on ly until technical feasibility is determined and su ch inventory can be capitalized, and thereafter such inventory s hall be charged as a cost only at the time such inv entory is sold, and ( y ) the cost to manufacture samples of Pr oducts distributed for use in the United States, ca lculated as follows : ( a ) with respect to purchases of Compounds or Produ cts from a Third Party, ( i ) those amounts that are actually paid to a Third Party by Sanofi or its Affiliates o r Sublicensees in connection with the manufacture o f the Product, including for storage, manufacturing site qualification, QA and QC ( including testing ), capit al equipment depreciation, customs duties or excise ta xes, plus ( ii ) Sanofi ’s FTE costs in connection wit h supply chain management of such purchased Compounds and Pr oducts . To the extent any non - refundable or non - creditable value added or similar tax is due with r espect to amounts paid to such Third Party for manu facture of any portion of a Product, such amounts will be cons idered Manufacturing Costs under this clause ( a )