definiens: means the fee paid, by [COMPANY] to OPT for sel1lices required to manufacture and package Products . The Manufacturing ' Fee ' is quoted in single final Product unit increments ( i.e " by the bottle, can or,, tube ) . The Manufacturing, Fee . shall include services for incoming inspection of materials ( including ' costs associated with establishing, testing and storing Raw Materials or Components ) ; compounding of bulk, packaging Product, testing Product for release, making Product ready for shipment, and minimum product documentation ( one copy of Certificate of, Analysis, batch records ) . The Manufacturing Fee does not include, without limitation, any research & deve.lopment support, package engineering studies, validation support, FDA audit support, extensive reporting requirements, or additional laboratory testing performed by an outside, testing laboratory or testing beyond that required ' in the Specifications, warehousing or distribution of Product, any materials costs or costs associated with establishing or manufacturing ne " ", materials such as art charges, die costs, plate costs, or packaging equipment change parts