definiens: shall mean costs incurred by a Party in connection with the Development of LicensedProducts in the Field in accordance with this Agreement and the Development Plan(s ) ( or prior to the first Development Plan, the Initial Development Plan ), including without limitation:6 ( a ) all Out - of - Pocket Costs, including, without limitation, fees and expenses associated with obtaining and maintainingRegistration Filings and Approvals ( including Pricing Approvals ) necessary for the Development andCommercialization of the Licensed Products in the Field under this Agreement;(b ) Development FTE Costs;(c ) Clinical Supply Costs;(d ) the costs and expenses incurred in connection with ( i ) Manufacturing process, formulation, cleaning, and shippingdevelopment and validation, ( ii ), Manufacturing scale - up and improvements, ( iii ) stability testing, ( iv ) qualityassurance / quality control development ( including management of Third Party fillers, packagers and labelers ), and(v ) internal and Third Party costs and expenses incurred in connection with ( A ) qualification and validation of ThirdParty contract manufacturers and vendors and ( B ) subject to the terms of this Agreement, establishing a primary orsecondary source supplier, including, without limitation, the transfer of process and Manufacturing technology andanalytical methods, scale - up, process and equipment validation, cleaning validation and initial Manufacturing licenses, approvals and Regulatory Authority inspections ( in each case, to the extent not included in Clinical Supply Costs orCommercial Supply Costs);(e ) Pre - Launch Marketing Expenses;(f ) any license fees and other payments under Existing Licenses and New Licenses to the extent attributable to theManufacture of Clinical Supply Requirements and/or the Development of Licensed Products in the Field under thePlans for the Territory ( which, for the avoidance of doubt, include activities in the Excluded Territory performed underthe Global Development Plan ) ; and(g ) any other costs or expenses specifically identified and included in the applicable Development Plan or included asDevelopment Costs under this Agreement