definiens: shall mean, with respect to a Co -Funded Product, those costs incurred by [COMPANY] for the Development of such Co -Funded Product in accordance with this Agreeme nt and the applicable Development Plan ( and in accordance with the Co -Funding Materials prior to approval of the Development Plans ) including : ( a ) Out -of - Pocket Costs ( including fees and expenses ) for obtaining Marketing Approvals for such Co - Funded Produ ct under this Agreement ; ( b ) Development FTE Costs ; ( c ) Clinical Supply Costs ; ( d ) Out -of - Pocket Costs incurred for ( i ) Manufacturing process, formulation, cleaning, and shipping development and validation, ( ii ), Manufacturing scale -up and improvements, ( iii ) stability testing, ( iv ) quality assurance / quality control development ( incl uding 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 Third Party contract manufacturers and vendors and ( B ) subject to the term s of this Agreement, establishing a primary or secondary source supplier, including, the transfer of process and Manufacturing technology and analytical methods, scale -up up to First Commercial Sale, process and equipment validation, cleaning validation an d initial Manufacturing licenses, approvals and Regulatory Authority inspections ( in each case, to the extent not included in Clinical Supply Costs or Commercial Supply Costs ) ; in each case for such Co -Funded Product under this Agreement ; 9 ( e ) any T hird Party License Payments under a Third Party License entered into in accordance with Section 16.7 below to the extent attributable to the Development of such Co -Funded Product ( to the extent not otherwise included in Development Costs ) ; and ( f ) any oth er costs or expenses for such Co -Funded Product specifically identified and included in the applicable Development Plan or included as Development Costs under this Agreement