definiens: means ( i ) all periodic safety reports or beneﬁt risk evaluation reports, ( ii ) all materialcorrespondence between Seller or any of Seller ’s Aﬃliates, on the one hand, and any Governmental Entity, on the otherhand, including any safety reports or updates, complaint ﬁles and product quality reviews, ( iii ) all other governmental reports, inspectional notices, Form 483 observations and customs notices, ( iv ) all medical inquiries, standard response or non - standard letters or talking points, ( v ) all complaints, investigations and corrective and preventive actions, ( vi ) all documents, reports, records, information and materials relating to any post - marketing requirements and post - marketing commitments, and ( vii ) any outstanding or ongoing regulatory item, in each case ( ( i ) through ( vii ) ), solely relating to the Speciﬁed Productsand to the extent owned and maintained by Seller or its Affiliates as of the Closing Date