definiens: means all ( a ) applications ( including all INDs and Drug Approval Applications and other Co - CommercializationTerritory Regulatory Filings ), registrations, licenses, authorizations and approvals ( including Regulatory Approvals, Reimbursement Approvalsand Product Labeling ) 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 meeting requests, pre - meetingsubmissions and minutes and official contact reports relating to any communications with any Regulatory Authority and reports issued by aRegulatory Authority in connection with any audit conducted by such Regulatory Authority ) and all supporting documents with respect thereto, including all investigator brochures, regulatory drug lists, advertising and promotion documents, drug safety and signaling update reports, adverse event files, complaint files ( including product technical complaints communications and handling ) and other material regulatorysubmissions and ( c ) Clinical Data and data contained or relied upon in any of the foregoing, including core data sheets, in each case ( i.e