definiens: means the fee paid by SIRIUS to HARMONY for services requiredto manufacture andpack ageProducts . The Manufacturing Feeisquoted insingle final Product unit increments ( i.e.by the bottle or tube . ) TheManufacturin gFeeshall include services forincoming inspection ofraw material, compounding of bulk, packaging Product, testing Product forrelease, making Product ready for shipment, and minimum product documentation ( one copy ofCertificate ofAnalysis . ) 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, oradditional laboratory testing beyond that required in the Specifications unless the provision ofsome or allof such services at no additional charge .Except as noted above, these services areinaddition to the Manufacturing Feeand shall bebilled by thehour at HARMONY 's then - prevailing R&D hourly rate inaccordance with Section XIcontained herein . Inaddition, theManufacturing Feedoes notinclude any material costs or costs associated with establishing or manufacturing new material such asartcharges, diecosts, plate costs, andpackaging equipment change parts .These items are billed separately in accordance with paragraph 2.8and 2.2 below . II PRODUCT MANUFACTURE AND SUPPLY 2.1 Manufacture and Purchase