definiens: means the fee paid by Company t o [COMPANY] for services required to manufacture, test, release, and package and label Product . The Manufac turing Fee is quoted in single final Product unit i ncrements ( e.g., by the bottle or tube ) . The Manufacturing Fe e shall cover all services for incoming inspection of Components, materials and API, compounding of bulk Product, packaging Product, testing Product for rel ease, making Product ready for shipment, and minimum Prod uct documentation ( one copy of Certificate of Analy sis, executed Batch records, Certificate of Compliance, BSE / TSE and any other documentation as specified in the QA Agreement ) and are stated in Schedule A. The Man ufacturing Fee does not include, without limitation, any Technical and Development Services support, package engineering studies, validation support, FDA audit support, extraordinary reporting requirements, or a dditional laboratory testing performed by an outsid e testing laboratory or testing beyond that required in the S pecifications . These services are in addition to th e Manufacturing Fee and shall be billed by the hour a t [COMPANY] ’s then - prevailing Technical and Development H ourly Rate in accordance with Section X. In addition, the Manufacturing Fee does not include warehousing of Product except as otherwise specifically provided in this A greement, any materials costs or costs associated w ith establishing or manufacturing new materials such as art charges, die costs, plate costs, and packaging equipment change parts