definiens: means ( a ) any BLA filed with the FDA to gain appr oval to market a biopharmaceutical product in the U.S., ( b ) a marketing authorization applicat ion filed with ( i ) the EMA under the centralized EM A filing procedure to gain approval to market a bioph armaceutical or diagnostic product in the E.U., or ( ii ) a Regulatory Authority in any E.U. country if the centralized EMA filing procedure is not used to gain approval to market a biopharmaceutical or diag nostic product in the E.U., or ( c ) any other equivalent or related Regulatory Submission filed i n support of approval to market a biopharmaceutical or diagnostic product in any country outside the U. S. or E.U., and, in each case ( ( a ) through ( c ) ), including any amendments thereto, and supplemental applications, but excluding Pricing Approval applications