definiens: means any and all applietttions ( including for ~orphan drug " .status ), registrations, licenses . alllhorizatioos and approvals ( including ull Regula!ory Approvals ), and noo--<:Iinical and clin;';al study authori7J1tion applkations or lIQ!ifica!io ns ( including all supponing fites . writings . data . studies and repons ) prepan.-d for submission 10 R GovernmenIQI Au!itori!y or researt : h ethics commitl~ .., wilh B view!o tile gl'lU1ting of any Regula!ory Approval . arK ! any correspondcllce to or with the I'DA or " ny other Governme ntal A utt.orilY with respect ! o the Compounds, tllC Seller Compouad Activities ( inclllding minutes and official contact reports relating ! o any communications with uny Governmental Au!itori!y ), and all dahl contained in any of!1le foregoing, including all INI > s, MAAs . regulatory drug liSlS, advertising and promotion documents