definiens: shall mean costs incurred by a Party in connectionwith the Development of Licensed Products in the Field in accordance with this Agreement and, except as provided in Sections 6.3(b ) and 6.3(c ), the Development Plan(s ) ( or prior to the firstDevelopment Plan, the Initial Development Plan ) ( including Development Costs for EYLEA aspart of a Combination PDGF Product that is a Licensed Product ), including, without limitation:(a ) all Out - of - Pocket Costs incurred in connection with such Development, including, without limitation, fees and expenses associated with obtaining and maintainingRegistration Filings and Approvals ( including Pricing Approvals, reimbursement and formularylistings ) necessary for the Development and Commercialization of the Licensed Products in theField under this Agreement;(b ) Development FTE Costs;(c ) Clinical Supply Costs;10 ( d ) the costs and expenses incurred in connection with ( i ) activities relatingto the Manufacturing process, formulation, cleaning, and shipping development and validation,(ii ) Manufacturing scale - up and improvements, ( iii ) stability testing, ( iv ) quality assurance / qualitycontrol development ( including management of Third Party fillers, packagers and labelers ), and(v ) internal and Out - of - Pocket Costs incurred in connection with ( A ) qualification and validation ofThird Party contract manufacturers and vendors and ( B ) subject to the terms of this Agreement, establishing a primary or secondary source supplier, including, without limitation, the transfer ofprocess and Manufacturing technology and analytical methods, scale - up, process andequipment validation, cleaning validation and initial Manufacturing licenses, approvals andRegulatory Authority inspections ( in each case, to the extent not included in Clinical SupplyCosts or Commercial Supply Costs);(e ) any license fees and other payments under Existing Licenses or NewLicenses to the extent attributable to the Manufacture of Clinical Supply Requirements and/or theDevelopment of Licensed Products in the Field under the Plans for the Territory ( which, for theavoidance of doubt, include activities in the Excluded Territory performed under the GlobalPDGF Development Plan, but exclude the Aventis Development Milestone Payments andAventis Royalties ) ; and(f ) any other costs or expenses specifically identified and included in theapplicable Development Plan or included as Development Costs under this Agreement