definiens: means, with respect to the Products, in any written or electronicform, all ( a ) documentation comprising the Regulatory Approvals or Orphan Designations, ( b ) dossiers, reports, supplements, records, data and other materials or correspondence filed with or received from any GovernmentalBody, including the EMA, relating to the Regulatory Approvals or application or submission for obtaining a RegulatoryApproval or Orphan Designations, ( c ) reports, supplements, records, data and other materials and correspondencerelated to the Products and reasonably necessary to, or otherwise limiting the ability to, manufacture, commerciallydistribute, sell, market or otherwise Exploit the Product, including minutes and official contact reports relating to anycommunications with any Governmental Body, and relevant supporting documents with respect thereto, including allregulatory drug lists, currently used final advertising and promotion documents, Adverse Event files and complaintfiles, pharmacovigilance records and studies, ( d ) clinical data, results ( including all tables, listings and graphs ) andreports, case report forms, and other materials or correspondence filed with or received from Governmental Bodies tothe extent relating to any clinical trial related to the Products, and ( e ) other data ( including clinical and pre - clinicaldata ) contained or relied upon in any of the foregoing, in each case ( ( a ), ( b ), ( c ), ( d ) and ( e ) ), to the extent in thepossession or control ( whether by ownership or other rights ) of Merck Serono or any of its Affiliates and, in each casereasonably necessary to, or otherwise limiting the ability to, manufacture, commercially distribute, sell, market orotherwise Exploit the Products