definiens: means any new drug application or other marketing authorization application, in each case, filed with the applicable Regulatory Authority in a country or other regulatory jurisdiction ( and all supplements and amendments thereto ), which application is required to commercially market or sell a pharmaceutical or biologic product in such country or jurisdiction, including ( a ) all New Drug Applications and Biologics License Applications submitted to the FDA in the U.S. in accordance with the FD&C Act with respect to a biologic or pharmaceutical product, ( b ) all MAAs submitted to ( i ) the EMA under the centralized EMA filing procedure in the E.U. or ( ii ) a Regulatory Authority in any country in the E.U. if the centralized EMA filing procedure is not used to gain Regulatory Approval in such country, ( c ) Japanese New Drug Application submitted t o the PMDA in Japan, ( d ) application to commercially market or sell a pharmaceutical or biologic product submitted to the National Medical Products Administration in China, or ( e ) any analogous application or submission to any Regulatory Authority in any o ther country or regulatory jurisdiction, and in each case ( ( a ) – ( e ) ), all supplements or amendments that may be filed with respect to any of the foregoing