definiens: means all files of the Companies or their respective Affiliates with respect to ( a ) all adverse event reports and otherdata, information and materials relating to adverse experiences and other safety issues with respect to the Products, ( b ) all materialcorrespondence between the Companies or their respective Affiliates, on the one hand, and any Regulatory Authority, on the other hand, relating to the Products, including any safety reports or updates, complaint files and product quality reviews, all clinical or pre - clinical dataderived from clinical studies conducted or sponsored by, or on behalf of the Companies or their respective Affiliates, 15and ( c ) all other documents, reports, records, dossiers, files and other data, information and materials relevant to compliance with theapplicable Law relating to the Products, product safety related information ( including periodic safety update reports and adverse eventdatabase information ), regulatory submissions, expiration dating, federal health care program price reporting information and informationrequired by Law or Regulatory Authority to be retained related to such price reporting, and written correspondence with any RegulatoryAuthority pertaining to Regulatory Approvals for Products