definiens: means all : ( a ) applications ( including all INDs and Drug Approval Applications and other Major Market Regulatory Filings ), registrations, licenses, authorizations, and approvals ( including Regulatory Approvals ) and designations ( including designations of a product as an drug or its equivalent outside of the United States ) ; ( b ) correspondence, materials and reports submitted to or received from Regulatory Authorities ( including pre -meeting submissions, minutes and official contact reports relating to any communications with any Regulatory Authority and reports issued by a Regulatory Authority in connection with any audit conducted by such Regulatory Authority ) and all supporting documents with respect thereto, including all regulatory drug lists, ad vertising and promotion documents, adverse event files, and complaint files ( including product technical complaints communications and handling ) ; and ( c ) Clinical Data and data contained or relied upon in any of the foregoing, in each case ( i.e., clauses ( a ), ( b ), and ( c ) above ), to the extent pertaining to a Compound or Product