definiens: means, collectively : ( a ) all INDs, NDAs, BLAs, establishment licenseapplications, drug master files, applications for designation as an under the Orphan Drug Act, for status under Section 506 of the FDCA ( 21 U.S.C. § 356 ) or for a Special Protocol Assessment underSection 505(b)(5)(B ) and ( C ) of the FDCA ( 21 U.S.C. § 355(b)(5)(B ) and ( C ) ) or all other similar filings ( including MAAsand counterparts to any of the foregoing in any country or region in the Territory ) as may be required by anyRegulatory Authority for the Development, manufacture, use or Commercialization of a Licensed Product in theTerritory ; ( b ) all supplements and amendments to any of the foregoing ; and ( c ) all data and other information containedin, and correspondence relating to, any of the foregoing