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 "Royalty" means the royalty on Net Sales of Product in the Indication, as set forth in Article Three below. 3 Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020 1.23 "TARA-002" means the ArTara pharmaceutical product intended to be similar to or biosimilar to OK-432. 1.24 "Territory" means worldwide. ARTICLE TWO PROJECT 2.1 Performance of Project. The University and/or Principal Investigator together with ArTara and the CRO will conduct the Project in accordance with the Project Plan and will use all reasonable endeavors consistent with their expertise to successfully complete the Project. It is the goal of the Project to use the Program Data as clinical support for Product Regulatory Filings and to gain approval to commercialize the Product for the Indication in the Territory. 2.2 Project Plan. The Project Plan as approved by each of the Parties may be modified or amended only upon mutual agreement of each of the Parties. The Project will consist of three phases: (a) Phase I: University and/or Principal Investigator will provide access to the Program Data to ArTara and the CRO at the University's facilities. ArTara and the CRO will be allowed to make complete copies of the original Program Data for the purposes of off-site data entry and storage, all as and only to the extent needed to support ArTara's efforts to accomplish the Project. University will provide ArTara and CRO the opportunity to examine the originals of medical records and supporting records for the Program Data at the University during normal business hours and