definiens: shall mea n January 1, 2016 . 1.56 shall mean costs incurr ed by a Party in connection with the Development of Licensed Products in the Field in ac cordance with this Agreement and, except as provide d in Sections 6.3(b ) and 6.3(c ), the Development Plan(s ) ( including Development Costs for EYLEA and/or any PDGF Licensed Product for use with or as part of a Licensed Product ( including, for clarity, as a Comb ination ANG2 Product that is a Licensed Product ) ), includin g, without limitation : ( a ) all Out - of - Pocket Costs incurred in connecti on with such Development, including, without limitation, fees and expenses as sociated with obtaining and maintaining Registratio n Filings and Approvals ( including Pricing Approvals, reimbur sement and formulary listings ) necessary for the Development and Commercialization of the Licensed P roducts in the Field under this Agreement ; ( b ) Development FTE Costs ; ( c ) Clinical Supply Costs ; ( d ) the costs and expenses incurred in connectio n with ( i ) activities relating to the Manufacturing process, formulation, cleaning, and s hipping development and validation, ( ii ) Manufactur ing scale - up and improvements, ( iii ) stability testing, ( iv ) quality assurance / quality control development ( including management of Third Party fillers, packagers and la belers ), and ( v ) internal and Out - of - Pocket Costs i ncurred in connection with ( A ) qualification and validation of Third Party contract manufacturers and vendors and ( B ) subject to the terms of this Agreement, establishin g a primary and/or secondary source supplier, inclu ding, without limitation, the transfer of process and Man ufacturing technology and analytical methods, scale -up, process and equipment validation, cleaning validati on and initial Manufacturing licenses, approvals an d Regulatory Authority inspections ( in each case, to the extent not included in Clinical Supply Costs or Commercial Supply Costs ) ; ( e ) any license fees and other payments under Ex isting Licenses and/or New Licenses to the extent attributable to the Manufact ure of Clinical 11 Supply Requirements and/or the Development of Licen sed Products in the Field under the Plans for the T erritory ( which, for the avoidance of doubt, include activit ies in the Excluded Territory performed under the G lobal ANG2 Development Plan, but exclude the Aventis ANG2 Royalties ) ; and ( f ) any other costs and/or expenses specifically identified and included in the applicable Development Plan and/or included as Deve lopment Costs under this Agreement