definiens: means the variable costs and fixed costs properly incurred with respect to the work performed in connection with the development of any Co - Development Product, including, without limitation ( a ) costs of studies conducted and services provided by contract research organisations and individuals, consultants, toxicology contractors, ( b ) any costs associated with securing the right to use any intellectual property rights owned by a Third Party, ( c ) costs relating to data management, ( d ) costs for preparing, submitting and reviewing or developing data or information for the purpose of an IND, IDE or other regulatory filing, and ( e ) any other direct costs including out of pocket external costs . For the purpose of this definition, shall be deemed to be the cost of labor, raw materials, supplies and other resources directly consumed in the development of the Co - Development Product, and shall be deemed to be the costs of facilities, utilities, insurance, facility and equipment depreciation and other fixed costs directly related to the development of the Co - Development Product allocated based upon the proportion of such costs directly attributable to support the development of the Co - Development Product . All cost determinations shall be made in accordance with GAAP