definiens: means, collectively : ( a ) all INDs, NDAs, MAAs, JNDAs, BLAs, establishment licenseapplications, Drug Master Files, applications for designation as an under the OrphanDrug Act, for status under Section 506 of the FDCA ( 21 U.S.C. § 356 ), for a Special ProtocolAssessment under Section 505(b)(4)(B ) and ( C ) of the FDCA ( 21 U.S.C. § 355(b)(4)(B ) ), or for Breakthrough Therapydesignation under Section 902 of the FDASIA and all other similar filings ( including, without limitation, counterparts ofany of the foregoing in any country or region in the Territory ) ; ( b ) all supplements and amendments to any of theforegoing ; and ( c ) all data and other information contained in, and correspondence relating to, any of the foregoing