definiens: means, as applicablc to Dcvice, Fonnulated Amikacin, or Product manufactured by [COMPANY] or its Third Party supplier, [COMPANY] 's or its Affiliate 's cost of manufacturing such Device, Fonnulated Amikacin, or Product for Development or Commercial purposes, which is equal to the sum of ( a ) for the Device, Fonnulated Amikacin or Product ( or components thereof ) made by [COMPANY], the costs of all direct material, direct labor, and allocable manufacturing overhead consumed, provided or procured by [COMPANY], in each case for the manufacture of the Device, Fonnulated Amikacin, or Product, and ( b ) for Device, Fonnulated Amikacin, or Product ( or components thereof ) made by [COMPANY] 's Third Party supplier, the out - of - pocket costs paid to such Third Party supplier by [COMPANY], to the extent such costs in ( a ) and ( b ) are incurred by [COMPANY] or its Affiliates and to the extent they are reasonably allocable to the manufacture of such Device, Fonnulated Amikacin, or Product . For clarity, Fully Burdened Manufacturing Cost shall not include any costs of scaling up Manufacturing for the Device or Fonnulated Amikacin, Development Costs, or capital expenses ( but shall include depreciation on capital expenses incurred for the Manufacture of Device, Fonnulated Amikacin, or Product ) . Fully Burdened Manufacturing Cost shall be calculated in a manner consistent with GAAP, consistently applied