definiens: or means any biologics license application or other marketing authorization application, in each case, filed with the applica ble Regulatory Authority in a country or other regulatory jurisdiction, which app lication is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction ( and any amendments thereto ), including ( i ) any market ing authorization application filed with the EMA un der the centralized EMA filing procedure to gain approval to market a pharm aceutical or biologic product in the E.U. or a Regulatory Authority in any E.U. country if the cen tralized EMA filing procedure is not used to gain approval to market a pharmaceutical or biologic pro duct in the E.U. and ( ii ) all Biologics License Applications ( ) or equivalent submitted to the FDA in the United States in accordance with 42 U.S.C. § 262 and, in each case, any ame ndments thereto and supplemental applications, but excluding Reimbursement Approval applications