definiens: or means ( a ) any BLA ﬁled with the FDA to gain approval to market abiopharmaceutical product in the U.S., ( b ) a marketing authorization application ﬁled with ( i ) the EMA under the centralizedEMA ﬁling procedure to gain approval to market a biopharmaceutical or diagnostic product in the EU, or ( ii ) a RegulatoryAuthority in any EU country if the centralized EMA ﬁling procedure is not used to gain approval to market a biopharmaceuticalor diagnostic product in the EU, or ( c ) any other equivalent or related Regulatory Authorization ﬁled in support of approval tomarket a biopharmaceutical or diagnostic product in any country outside the U.S. or EU, and, in each case ( ( a ) through ( c)),including any amendments thereto, and supplements, variations, extensions and renewals thereof, but excluding PricingApproval applications