definiens: shall mean original documents in any format in thepossession or control of the Seller and/or its Subsidiaries as of the Closing, of all RegulatoryApprovals, dossiers, quality specifications for the manufacture, import, release and testing of theProduct and its components and all correspondence with, or reports or other materials submittedto, any Governmental Authority related to the Exploitation of the Product, including all U.S. and 13 Exhibit 2.1non - U.S. regulatory applications, filings, submissions and approvals ( including all InvestigationalNew Drug Applications and New Drug Applications with the FDA, and foreign counterpartsthereof, all Regulatory Approvals and all complaint files, periodic safety reports and adverse drugexperience reports ) for the Product, the Exploitation of the Product or use of any Purchased Assetor related to the Plazomicin Business, and all technical and other information contained therein, and all correspondence with the FDA and other Governmental Authorities relating to any of theforegoing, including correspondence related to any serious adverse events associated with theProduct