definiens: means ( i ) a Biologics License Application submitt ed to the FDA pursuant to Section 351(a ) of the Public Health Service Act and the regulations promulgated thereu nder, including all amendments and Supplemental Applicati ons with respect thereto ( ) ; ( ii ) an application for authorization to market and/or sell a biological pr oduct submitted to a Regulatory Authority in any co untry or jurisdiction other than the U.S., including all ame ndments with respect thereto, including, with respe ct to the European Union, a marketing authorization applicati on filed with the EMA pursuant to the Centralized A pproval Procedure or with the applicable Regulatory Authori ty of a country in the European Economic Area with respect to the decentralized procedure, mutual recognition or any national approval procedure ( ) ; or ( iii ) with respect to any biological product for which a BLA o r MAA has been approved by the applicable Regulator y Authority, an application to supplement or amend su ch BLA or MAA to expand the approved label for such biological product to include use of such biologica l product for an additional indication ( )