definiens: means, collectively : ( a ) all INDs, Approval Appli cations, establishment license applications, Drug Master Files, applicatio ns 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 Sec tion 505(b)(4)(B ) and ( C ) of the FD&C Act ( 21 U.S.C . § 355(b)(4)(B ) ) and all other similar filings ( includ ing counterparts of any of the foregoing in any cou ntry or region in the Territory ) ; ( b ) any applications for Regulat ory Approval or Price Approval and other applicatio ns, filings, dossiers or similar documents submitted to a Regula tory Authority in any country for the purpose of ob taining Regulatory Approval or Price Approval from that Reg ulatory Authority ; ( c ) any Patent - related filings w ith any Regulatory Authority ; ( d ) all supplements and amend ments to any of the foregoing ; and ( e ) all data and other information contained in, and correspondence with a ny Regulatory Authority relating to, any of the for egoing