definiens: means anyone of them ; means the following ( including both hard copies and electronic copies ), with respect to each of the Products : ( a ) all NDS set forth on Schedule 4.1.22 and any and all supplements, amendments, annual reports and regulatory files relating thereto, including any and all regulatory filings ( including any registrations and licenses, all DINs, regulatory drug lists and correspondence, and Governmental Authority and the Vendor 's minutes of meetings and telephone conferences ), Licences and supporting documents, annual reports, validation data, pre - clinical and clinical studies and tests related to the Products and any Improvements thereto, and all audit reports of clinical studies, all investigational new drug applications and amendments, supplements, annual reports and safety reports associated therewith, any ANDS, all drug master files, Health Canada approvals for export, all documents relating to any clinical studies for indications whether or not approval has been granted to such indications by Health Canada ; ( b ) all other regulatory information, including records maintained under current good manufacturing practices or other record keeping or reporting requirements of Health Canada or any other Governmental Authority, including all submissions, correspondence and communications with Governmental Authorities in connection with the Products ( including any advertising and promotion documents and similar forms ), all documents relating to recalls or market withdrawals of any of the Products, copies of all promotional materials distributed, copies of all scientific or technical materials regarding any of the Products, and similar files, health hazard evaluations, complaint files, manufacturing records ( including standard operating procedures ), laboratory notebooks, and manufacturing audit reports of the Vendor and third party manufacturers ; as well as any foreign ( non - Canadian ) equivalents of any of the foregoing and any internal memoranda and documents relating to any of the above to the extent to which the Vendor has the right to such information pursuant to the provisions ofthe applicable Contracts related to the Products ; means the price payable by the Purchaser to the Vendor for the Purchased Assets provided for in Section 3.1 ; has the meaning ascribed thereto in Section 2.1 ; CH02/22304967.3 12