definiens: means the fee paid by [COMPANY] to OPT for services 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 & development support, package engineering studies, validation support, FOA 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 new materials such as art charges, die costs, plate costs, or packaging equipment change parts