diagnosis and treatment of the Indication using OK-432. 1.14 "Program Data" means the data set forth on Exhibit A including all case reports forms, source data, and safety data in the possession of or available to University arising from the Program and any other data and information included in the IND. 1.15 "Project" shall mean the compilation and available statistical analyses of the Program Data as described in the Project Plan, which is summarized in Section 2.2. 1.16 "Project Documentation" shall mean the documentation created and generated by ArTara and CRO in the conduct of the Project that incorporates or is based upon Program Data. 1.17 "Project Plan" means the plan for the Project mutually agreed upon by the Parties as summarized in Section 2.2. 1.18 "Right of Reference" means the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining Regulatory Approvals, including the ability to make available the underlying raw (source) data from the investigation for audit, if necessary. 1.19 "Regulatory Approvals" means the medical, technical and scientific licenses, registrations, authorizations and approvals (including without limitation, approvals of IND's, New Drug Applications ("NDA's") and equivalents, supplements and amendments, pre- and post- approvals, pricing and third-party reimbursements approvals and labeling approvals) for the development and commercialization of pharmaceutical products. 1.20 "Regulatory Authorities" means any applicable national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of a pharmaceutical product in a regulatory jurisdiction. 1.21 "Regulatory Filings" means collectively, IND's, Product License Applications, Drug Master Files, NDA's, Biological License Applications ("BLAs") including supportive and annual filings and/or any other equivalent or comparable filings as may be required by Regulatory Authorities to obtain Regulatory Approvals. 1.22