definiens: means the transfer, scale - up, testing, qualificat ion, and licensure of a Facility necessary to Manufacture a Product, including : ( a ) transfer of the Manufacturing Process to the Facili ty, including the Process description, technical inform ation, Manufacturing documentation, analytical meth ods, reference standards, materials, including, if state d in an applicable SOW, a portion of the master cel l bank and/or working cell bank ; ( b ) implementation of the Manufa cturing Process at such Facility, including technic al assistance and cooperation by appropriate employees of [COMPANY] [ * * * ] ; ( c ) all Manufacturing Process fit activities to the extent mutually agreed in the applicable SOW, including required process development and valida tion work and process engineering required to modify / equ ip and qualify such Facility for commercial Manufac turing ; and ( d ) regulatory support for all required Regulat ory Approvals of the Facility for commercial Manufa cturing, each as relevant for the Facility in question and a s further described in the applicable SOW(s )