definiens: means, collectively, ( a ) all INDs, NDAs, establishment license applications, drug master files, applications fordesignation of a Licensed Product 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 under Section 505(b)(4)(B ) and ( C ) of the FDCA ( 21 U.S.C. § 355(b)(4)(B ) ) or all other similar filings ( including, without limitation, any counterparts of any of the foregoing in any country region in the Territory, e.g. a CTN ) as may be required by any Regulatory Authorityfor the Development or Commercialization of a Licensed Product ; ( b ) all supplements and amendments to any of the foregoing ; and ( c ) all data contained in, and correspondence relating to, any of the foregoing