definiens: means all books, records, ﬁles and documents related to the Business or the Product or other Purchased Asset ( includingsales, pricing, promotional, research and development, data ( including Data ), customer and supplier lists, marketing studies, consultant reports, physician databases and correspondence ( excluding invoices ), complaint ﬁles and adverse drug experience ﬁles, correspondence with GovernmentalAuthorities, manufacturing ﬁles, registrations and commercial ﬁles and materials ( including packaging and graphics ﬁles ) and, to the extent notoriginals, true and complete copies of all ﬁles primarily relating to the ﬁling, prosecution, issuance, maintenance, enforcement or defense of anyBusiness Intellectual Property, including written Third Party correspondence, records and documents related to research and non- clinical and clinicaltesting and studies for the Product conducted by or on behalf of Sellers, including laboratory and engineering notebooks, procedures, tests, dosage, criteria for patient selection, safety and eﬃcacy and study protocols, investigators brochures and all vigilance and other safety records ) in all forms, including electronic, in which they are stored or maintained, and all data and information included or referenced therein, in each case that arelicensed, owned or controlled by or otherwise in the possession of Sellers in respect of the Product . Books and Records shall include the documentsdelivered to or received by the FDA that are described on Schedule 2.3(a)(iii ) ( the )