definiens: means, with respect to the Product and the Authorized GenericProduct, all ( a ) documentation comprising the Purchased Regulatory Approvals and associated RegulatorySubmissions, ( b ) correspondence and reports primarily related to the Product or the Authorized Generic Product in theTerritory and necessary to, or otherwise limiting the ability to, commercially distribute, sell or market the Product inthe Territory as of the Closing Date submitted to or received from Governmental Authorities ( including minutes andofficial contact reports relating to any communications with any Governmental Authority ) and, to the extent relatedprimarily to the Territory, relevant supporting documents with respect thereto, including all regulatory drug lists, materials submitted to FDA under FDA Form 2253, final versions of advertising and promotion materials, and adversedrug experience reports ( periodic and expedited ) and Adverse Event files and ( c ) data ( including clinical and pre - clinical data ) referenced in any of the foregoing that relates primarily to the Territory, in each case ( ( a ), ( b ) and ( c)),(x ) to the extent in the possession or Control of Seller or any of its Affiliates and ( y ) excluding the Excluded Items