definiens: means, with respect to any API, Clinical Product, Marketed Product or any intennediate of any of them, Manufactured by or on behalf of the Party responsible for Manufacturing such item as set forth herein ( the " Manuf ~ tgring Party ! ! ), the Manufacturing Party 's costs ( including the costs associated with product testing and release activities ) of Manufacturing such API, Clinical Product, Marketed Product ( in Standard Delivered Fonn in the case of Clinical Product or Marketed Product ) or intetmediate of any of them in accordance with the terms of this Agreement, including the following components : 7 CONFIDENTIAL TREATMENT REQUESTED Rfo"trictad R + ) Confid4fltild Smlted acceu I. For API, Clinical Product, Marketed Product or any intermediate of any of them Manufactured at a Manufacturing Facility owned and operated by the Manufacturing Party or its Affiliates : A. Direct Manufacturing Costs ( i ) Raw materials Oi ) Directlabor ( iii ) Factory overhead costs that can be directly attributed to the product, such as equipment maintenance and repair, . ongoing stability program costs, other plant services ( e.g., waste treatment, waste incineration ), supplies, and depreciation on direct, capital assets ( capital assets that can be directly attributed to the product )