definiens: means with respect to any Transferred Products, the regulatory documentation, or portion thereof, related to each such product, including ( as applicable ) all applications for Transferred Registrations and renewals thereof ( including investigational new drug applications, orphan designations, new drug applications, abbreviated new drug applications and marketing authorization appli cations ), and the safety reports, information on adverse events, and copies of all correspondence, reports, or minutes with any Governmental Entity, and all data submitted to Governmental Entities in connection with Transferred Registrations, pricing studi es, and documents ( including, without limitation, laboratory, clinical and pre -clinical animal study data ) relating to the Transferred Registrations or to the subject matter of the Transferred Registrations to the extent relating to the Transferred Product s. For the avoidance of doubt, Regulatory Documentation shall not include laboratory notebooks, internal audit reports or batch records ( other than those batch records contained in Transferred Registrations )