definiens: means the COSt of lmegrelin ProdUCIS shipped in either bulk or final therapeutic form, as the Panics may tncn agree . As used herein, the COSI of the Integrelin Products means ( i ) in the case of produCIS and services acquired from Third Panies, paymems made 10 such Third PaniCS, and ( Ii ) in the case of manufacturing services perfonncd by the Parties, including manufactUring services in suppon of Third Pany manufacturing, the actual unit costs of manufacture In bulk form or fillli maoufacturiog, 35 the case may be, plus Inc variances and other costs specifically provided for herem [ Actual unit COSIS shall consist of direct materia ! and direct Jabor costs plus manufacturing overhead directly attributable to the Integrciin Products al Slandard, all CJlculaled in accordaoce WIth fUliOlU, bIe cost accounlill8 methods, consistendy applied, of the Party performing the workJ [ Direct material costs shall Include the COSts lI'K : Urred III purt : hlIsmg malCriaJs, tncludmg sales and eltcise taxes Imposed thereon and CUStoms duty and charges levied by govenvnent authormes, and all costs of packagmg components . ] [ Direct Jabor shall include the cost of employees engaged m duect manufactunng actlYltteS and dIrect or Indirect quality control and qUility assufllnce aCllvilies woo are directly employed III Integrelm Product manufactunng and packaging . ] 3 CONFIDENTIAL TREATMENT REQUES~ ' 00