definiens: means ( a ) registrations and applications for, or other filings orsubmissions with respect to, the Regulatory Approvals, including reports, data and other written materials filedby the Seller or its agent as part of or referenced in, the Regulatory Approvals, and the Seller 's riskmanagement plan ( or any other risk management plan owned by the Seller ) with respect to the Products, ( b)any other filings or submissions with respect to the Products made with any Governmental Entity orRegulatory Authority, ( c ) compliance documentation, including complaint history, compliance history(including any field alerts, market withdrawals and recalls ), pharmacovigilance, requests for additionalscientific information with respect to the Products, manufacturing change controls, process / lab investigations, stability protocols and test data and product development packages, ( d ) all annual reports delivered by theSeller to the applicable Regulatory Authority(ies ) in respect of the Products, ( e ) all Registration Dossiers and(f ) written communications, and written summaries and minutes of other communications, with the FDA orother Governmental Entities or Regulatory Authorities to the extent relating to the Products, in each caseowned or controlled by the Seller