definiens: means, collectively : ( a ) all INDs, NDAs, BLAs, est ablishment license applications, drug master files, applicatio ns 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 Pro tocol Assessment under Section 505(b)(4)(B ) and ( C ) of th e FDCA ( 21 U.S.C. § 355(b)(4)(B ) ) or all other simi lar filings ( including MAAs and counterparts to any of the foregoing in any country or region in the Terri tory ) as may be required by any Regulatory Authority for the Development or Commercialization of a Licensed Pro duct in the Territory ; ( b ) all supplements and amendment s to any of the foregoing ; and ( c ) all data and oth er information contained in, and correspondence relati ng to, any of the foregoing