definiens: shall mean, [ * * * * * * * * * * ], costs and expenses incurred by a Party or its Affiliates for the Product, from and after t he Effective Date directly in connection with the D evelopment of the Product in the Field in accordance with this Ag reement and the applicable Development Plan, includ ing : ( a ) all Out - of - Pocket Costs, including fees and expenses associated with preparing and submitting Registration Filings ( other than for Pricing Approvals ) and obtaining Marketing Approva ls necessary for the Development and Commercialization of the Product in the Field under this Agreement i n accordance with such Development Plan, but excludin g amounts captured under Section 7.1(d ) as Other Sh ared Expenses ; ( b ) Development FTE Costs ; ( c ) Development Supply Costs ; ( d ) Commercial Supply Costs for any Product Manu factured prior to the First Commercial Sale in the United States to meet the Co mmercial Supply Requirements for the United States ; ( e ) the costs and expenses incurred in connectio n with ( i ) Manufacturing process, formulation, cleaning, and shipping development and validation [ * * * * * * * * * * ], ( ii ) Manufacturing scale- up and improvements ( including Manufacturing Process Impro vements ), ( iii ) stability testing, ( iv ) quality assurance / quality control development ( including ma nagement of Third Party fillers, packagers and labe lers ), ( v ) the development of any device or delivery system fo r use with, or that otherwise is included in, the F inished Product, and ( vi ) internal and Third Party costs 8 and expenses incurred in connection with ( A ) qualif ication and validation of Third Party contract manu facturers and vendors and ( B ) establishing a primary or secon dary source supplier, which, for clarity, may be an Affiliate of Regeneron or a Third Party contract manufacturing o rganization, including, the transfer of process and Manufacturing technology and analytical methods ( wh ether such transfer occurs before or after the Firs t Commercial Sale ), scale - up, process and equipment v alidation, cleaning validation, capital expenditure s, and initial Manufacturing licenses, approvals and Regul atory Authority inspections ( in each case, to the e xtent not included in Development Supply Costs or Commercial Supply Costs ) ; ( f ) any other costs or expenses specifically ide ntified and included in such Development Plan or expressly included as Developme nt Costs under this Agreement