definiens: mean s, collectively : ( a ) all INDs, Approval Applications, establishment license applications, Drug Master Files, applications for designation as an under the Orphan Drug Act, for status under Section 506 of the FD&C Act ( 21 U.S.C. § 356 ) or for a Special Protocol Assessment under Section 505(b)(4)(B ) and ( C ) of the FD&C Act ( 21 U.S.C. § 355(b)(4)(B ) ) and all other similar filings ( including counterparts of any of the foregoing in any country or region in the Territory ) ; ( b ) any applications for Regulatory Approval or Price Approval and other applications, filings, dossiers or similar documents submitted to a Regulatory Authority in any country for the purpose of obtaining Regulatory Approval or Price Approval from that R egulatory Authority ; ( c ) all supplements and amendments to any of the foregoing ; and ( d ) any correspondence with Regulatory Authorities in connection with any of the foregoing