definiens: means the fee paid by COMP ANY to [COMPANY] for services required to manufacture and package Products . The Manufacturing Fee is quoted in single final Product unit increments ( i.e. by the bottle or tube . ) The Manufacturing Fee shall include services for incoming inspection of raw material, compounding of bulk, packaging Product, testing Product for release, making Product ready for shipment, and minimum product documentation ( five ( 5 ) copies of Certificate of Analysis . ) The Manufacturing Fee does not include, without limitation, any Research & Development support, Package Engineering studies, Validation support, Warehousing or Distribution of Product, FDA audit support, extensive reporting requirements, or additionallaboratoty testing beyond that required in the Specifications . These services are in addition to the Manufacturing Fee and shall be billed by the hour at [COMPANY] 's then - prevailing R&D hourly rate . In addition, the Manufacturing Fee does not include any material costs or costs associated with establishing or manufacturing new material such as art charges, die costs, plate costs, and packaging equipment change parts . These items are billed separately in accordance with paragraph 2.8 below