definiens: means ( a ) submissions to any Regulatory Authority, including INDs, Drug Approval Applications, Drug Master Files, correspondence with regulatory agencies ( registra tions and licenses, regulatory drug lists, advertising an d promotion documents ), period safety update report s, adverse event files, complaint files and manufacturing reco rds and, if applicable, any updates or supplements to any of the foregoing, ( b ) any minutes or contact logs with respect to any telephone conferences conducted wit h any Regulatory Authority relating to the subject matter described in clause ( a ) of this sentence, and ( c ) materials in the working regulatory and clinical files of [COMPANY] pertaining to the conduct of upcoming annual review s and required reports to the FDA that have yet to be fil ed, in each case ( ( a ), ( b ), and ( c ) ) to the extent relating to the Licensed Compound or Licensed Products and Controll ed by [COMPANY] or its Affiliates as of the Transfer Da te, including those items identified on Schedule 3.1