definiens: means the fee paid by COMPANY to [COMPANY] for services required to manufacture and packageProducts . The Manufacturing Fee is quoted in single final Product unit increments ( i.e. by the bottle or tube ) . TheManufacturing Fee shall include services for incoming inspection of materials, compounding of bulk, packagingProduct, testing Product for release and marketed product annual stability, making Product ready for shipment, andminimum product documentation ( one copy of Certificate of Analysis . ) The Manufacturing Fee does not include, without limitation, any research & development support, package engineering studies, validation support, FDA auditsupport, extensive reporting requirements, or additional laboratory testing performed by an outside testing laboratoryor testing beyond that required in the Specifications . These services are in addition to the Manufacturing Fee and shallbe billed by the hour at [COMPANY] ’s then - prevailing R&D hourly rate in accordance with Section XI contained herein . Inaddition, the Manufacturing Fee does not include warehousing or distribution of Product, any materials costs or costsassociated with establishing or manufacturing new materials such as art charges, die costs, plate costs, and packagingequipment change parts