definiens: shall mean : ( a ) all applications for Regulatory Approva l ( including MarketingApproval Applications ) ; ( b ) all Regulatory Approvals, includi ng INDs and Marketing Approvals ; ( c ) all supporting documen tscreated for, referenced in, submitted to or received fro m an applicable Regulatory Authority relating to any of theapplications or Regulatory Approvals described in clauses ( a ) and ( b ), including drug master ﬁles ( or any equivalent th ereofoutside the U.S. ), annual reports, regulatory drug lists, advertising and promotion documents shared with Regulat oryAuthorities, adverse event ﬁles, complaint ﬁles and Manufactur ing records ; and ( d ) all correspondence made to, made wi thor received from any Regulatory Authority ( including writt en and electronic mail correspondence and minutes from me etings, discussions or conferences ( whether in person or by audio conf erence or videoconference ) )