definiens: means all ( a ) applications ( including all INDs, cli nical trial applications and drug approval applications ), regis trations, licenses, authorizations and approvals ( i ncluding Regulatory Approvals ) ; ( b ) correspondence and repor ts submitted to or received from Regulatory Authori ties ( including minutes and official contact reports rel ating to any communications with any Regulatory Aut hority ) and all supporting documents with respect thereto, including all regulatory drug lists, advertising an d promotion documents, adverse event files and complaint files ; and ( c ) preclinical, clinical and other data resul ts, analyses, publications, and reports contained or referred to in any of the foregoing ; in each case ( ( a ), ( b ) and ( c ) ) relating to the Licensed Compound or a Licensed Product . For th e avoidance of doubt, Regulatory Documents include Regulatory Approvals and Regulatory Filings