definiens: means the expenses incurred in connection with the Development of Licensed ProductL ~ velo ~ ment Expenses shall i ~ cl ~ E~~2_~ are not limited ~f studies - onthe toxicological, -pre - cHnical, pharmacokmetic, metahoTlc - or~-------'---\ clinical aspects of Licensed Products conducted internally or by individual investigators, of design and manufacture of any required prototype devices, of consultants necessary for the I purpose of obtaining and/or maintaining Regulatory Approval of Licensed Products in the Territory, and costs ( and related fees ) for preparing, submitting, reviewing or developing I data or information for the purpose of submission to a governmental authority to obtain I and/or maintain Regulatory Approval of Licensed Products in the Territory . I _ _ _ ~'·Drug Approval Application " means an application for Regulatory Approval required to be approved before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction, including, for the purposes of Regulatory Approval in the United States, a New Drug Application and all supplements filed pursuant to the requirements of the FDA ( including all documents, data and other information concerning Licensed Products which are necessary for, or included in, FDA approval to market the Licensed Products, as more fully defined in 21 c. F.R. § § 314.1 et seq . )