information it considers to be its Confidential Information, ArTara may require redaction of that Confidential Information; provided, however, that ArTara shall not require removal of information necessary for complete and accurate presentation and interpretation of the Program Data and results. The Publication shall occur within […***…] of the date the Project is closed or terminated, or University and/or Principal Investigator shall be free to publish Program Data and results at that time. 8 Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020 ARTICLE SIX REPRESENTATIONS; INDEMNIFICATION 6.1 Representations. University represents: (a) The Program is being, and has been, conducted in accordance with all applicable local, state and federal laws, and regulations, including, but not limited to, the Federal Food, Drug and Cosmetic Act and the regulations of the FDA, International Conference on Harmonization Good Clinical Practices as adopted in the applicable FDA regulations ("GCP's"), and the Form FDA 1572 Statements of Investigators. (b) The Program is being and has been conducted in accordance with all applicable medical privacy laws or regulations, including without limitation, by obtaining any required subject informed consent to allow ArTara and ArTara's authorized representatives, FDA and other Regulatory Authorities access to and use of enrolled subjects' medical information as may be necessary for ArTara to receive and use Program Data under this Agreement. (c) The clinical studies included in the Program are and have been conducted in accordance with the applicable protocol associated with the BB-IND#5266 held by the Principal Investigator. (d) University represents that informed consent was required from all individual subjects prior to enrollment in the Program, and that the Program was approved by the Institutional Review Board of the University. (e) University represents that it is authorized to enter into this Agreement and that the terms of this Agreement are consistent with the rules, regulations, policies