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 applicat ion 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 sub mitted to the FDA in the United States in accordance with the FD&C Act with respect to a biol ogic or pharmaceutical product, ( b ) all MAAs submitted to ( i ) the EMA under the centralized EMA filing procedure in the EU or ( ii ) a Regulatory Authority in any EU country if the centralized EMA filing procedure is not used to gain Regulatory Approval in such country, ( c ) Japanese New Drug App lication submitted to the Ministry of Health, Labor and Welfare in Japan or ( d ) any analogous app lication or submission with any Regulatory Authority in any other country or regulatory jurisd iction