definiens: means ( a ) applications for marketing approvals ( i ncluding all investigational applications, Emergency Use Authori zation applications, premarket notification submiss ions, premarket approval submissions, material labeling s upplements, Regulatory Authority meeting requests, and core data sheets ), registrations, licenses, authorizatio ns, and approvals ( including Regulatory Approvals ), ( b ) orrespondence and reports submitted to or received from Regulatory Authorities ( including minutes and official contact reports relating to any communications with any Regulatory Authority ) and all supporting docum ents with respect thereto, including all regulatory lists, ad vertising and promotion documents, adverse event fi les, and complaint files, and ( c ) data contained or relied u pon in any of the foregoing, in each case ( ( a ), ( b ), and ( c ) ) relating to a Product in order to Develop, manufacture, mark et, sell or otherwise Commercialize a Product in a particular country or jurisdiction . inc ludes any MAA, Emergency Use Authorization, or Regu latory Approval