resources required during Phase II. The goal of Phase II will be to compile the Project Documentation. (c) Phase III: CRO will convert Program Data to eCTD format for submission to Regulatory Authorities. University recognizes that ArTara may receive specific data requests from Regulatory Authorities in connection with ArTara's presentations of Program Data to support Regulatory Filings. University will assist ArTara in responding to such requests for data or access to source data from Regulatory Authorities. ArTara agrees to notify University of such requests as soon as is practicable. The goal of Phase III will be filing of a BLA based on Project Documentation and response to Regulatory Authorities. 4 Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020 (d) Phase IV Optional: Upon mutual written agreement of University and ArTara, ArTara may sponsor, and University may conduct, new Product or Product-related clinical studies (for example, follow-up studies) to support the goal of the Project or as may be useful for gaining or maintaining Regulatory Approvals for the Product for the Indication. Any such studies will be at the sole discretion of each Party subject to terms and conditions to be mutually agreed upon in agreements separate from this Agreement. Richard Smith, MD will be given first consideration as a principal investigator for all new Product or Product- related clinical studies, in addition to other sites provided final site selection will be based on the best interest of the Project. (e) Phase V: Publication: Collected data from the Project will be used to write a paper by the University and/or Principal Investigator (the "Publication") as a follow up to the publication in 2009 (Smith MC, Zimmerman MB, Burke DK, Bauman NM, Sato Y, Smith RJ; OK-432 Collaborative Study Group. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations. Laryngoscope. 2009Jan;119(1):107-15. doi: 10.1002/lary.20041. PubMed