definiens: means, collectively : ( a ) all INDs, NDAs, establishment license applications, drugmaster files, applications for designation as an under the Orphan Drug Act, for status underSection 506 of the FDCA ( 21 U.S.C. § 356 ) or for a Special Protocol Assessment under Section 505(b)(4)(B ) and ( C ) of theFDCA ( 21 U.S.C. § 355(b)(4)(B ) ) or all other similar filings ( including MAAs and counterparts to any of the foregoing in anycountry or region in the Territory ) as may be required by any Regulatory Authority for the Development orCommercialization of a Licensed Product in the Territory ; ( b ) all supplements and amendments to any of the foregoing ; and(c ) all data and other information contained in, and correspondence relating to, any of the foregoing