definiens: means, with respect to the Product or any Other Product, all(a ) documentation comprising the Regulatory Approvals, including all submissions, reports and correspondencerelating thereto, ( b ) correspondence and reports necessary to, or otherwise describing the ability to, commerciallydistribute, sell or market the Product or such Other Product, as applicable, submitted to or received fromGovernmental Authorities ( including minutes and official contact reports relating to any communications with anyGovernmental Authority ) and relevant supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, annual and periodic reports, adverse event files and complaint files and(c ) data ( including clinical and pre - clinical data and CMC data ) contained in any of the foregoing . RegulatoryDocumentation excludes the Product core data sheet, which shall be retained by [COMPANY] or an Affiliate ofAstraZeneca commensurate with continuing safety responsibilities for the Product