definiens: means, collectively : ( a ) any IND, NDA, MAA, establishment license application, drug master file, application for designation as an under the Orphan Drug Act, for status under Section506 of the FDCA ( 21 U.S.C. § 356 ), for status under Section506 of the FDCA ( 21 U.S.C. § 356 ), or for a Special Protocol Assessment underSection 505(b)(4)(B ) and ( C ) of the FDCA ( 21 U.S.C. § 355(b)(4)(B ) ) and all othersimilar filings ( including counterparts of any of the foregoing in any country or regionin 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 theforegoing