definiens: means, collectively : ( a ) all INDs, Approval Appli cations, establishment license applications, Drug Master Files, applicatio ns for designation ( including as an under the Orphan Drug Act, for status under Section 506 of the FD&C Act ( 21 U.S.C. § 356 ) or fo r 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 counterpar ts of any of the foregoing in any country or region in the Territory ) ; ( b ) any applications for Marketing Appr oval or Price Approval and other applications, fili ngs, dossiers or similar documents submitted to a Regula tory Authority in any country for the purpose of ob taining Marketing Approval or Price Approval from that Regu latory Authority ; ( c ) any Patent - related filings wi th any Regulatory Authority ; ( d ) all supplements and amend ments to any of the foregoing and submissions made related to any of the foregoing ; ( e ) all documents referenced in the complete regulatory chronology fo r each Marketing Approval ; ( f ) confirmed meeting requests and meeting minutes ; ( g ) foreign equivalents of any of the foregoing ; and ( h ) all data and other information c ontained in, and correspondence with any Regulatory Authority relating to, any of the foregoing