Transferred Clinical Trials. Without limiting its obligations under Section 3.2.1, Licensee shall be solely responsible, at its own cost and expense, for conducting and completing all Transferred Clinical Trials and any other trial to satisfy post-marketing commitments necessary or desirable to obtain or maintain Regulatory Approval of and enable and support the Manufacture and Commercialization of Licensed Products in the Territory. Axsome and Licensee shall undertake all actions reasonably necessary to transfer Axsome’s responsibilities and obligations under the Transferred Clinical Trials to Licensee and to assign to Licensee those clinical trial agreements listed in [Schedule 3.3.1], which are in existence as of the Effective Date and under which such Transferred Clinical Trials are being conducted.

Ongoing Clinical Trials. If at the time Allergan provides notice of termination pursuant to Section 11.2.2 or upon UroGen’s termination pursuant to Section 11.2.1, Section 11.2.3, or Section 11.2.5, there are ongoing Clinical Trials being conducted by or on behalf of Allergan (or its Affiliate or Sublicensee), then Allergan shall terminate such Clinical Trial as permitted by Applicable Law and shall be responsible for the diligent, ethical and orderly wind-down of the Clinical Trials in accordance with Applicable Law and the instructions of any applicable Regulatory Authority. Allergan shall endeavor to complete any such termination within ​ days of the relevant notice of termination and shall provide to UroGen a final clinical study report for any such terminated Clinical Trial no later than ​ months following the date of such Clinical Trial’s termination.

Maximum Payment for Clinical Trials. For the milestone events of [Sections 4.3.2] (a) and (b), regardless of the number of Clinical Trials conducted, the maximum payment due for each Milestone Event shall not exceed the amount due for the ​. For clarity, the maximum amount due under [Section 4.3.2(a)] is ​; the maximum amount due under [Section 4.3.2(b)] is ​. Amounts paid under [Section 4.3.2(a)] are not creditable against amounts due under [Section 4.3.2(b)] and vice versa.

“Clinical Trials” means a clinical trial in human subjects designed to measure the safety and/or efficacy of a Licensed Product. Clinical Trials shall include Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials and any pre-clinical or post-Regulatory Approval studies undertaken in relation to any Licensed Product.

create, implement and review the overall strategy for Research and Development, including the design of all Clinical Trials, conducted under all Research Plans, Early Clinical Development Plans and Late Clinical Development Plans, including Required Phase 4 Clinical Trials, but for clarity no Voluntary Phase 4 Clinical Trials or Supplemental Trials;

Phase 1 ACTR+rituximab Clinical Trials. Unum will promptly provide SGI with all safety data generated with respect to # the product candidate in the Existing Phase 1 Clinical Trial and all correspondence to and from any Regulatory Authority regarding such product candidate, and # the product candidate in the First Viral Phase 1 Clinical Trial and all correspondence to and from any Regulatory Authority regarding such product candidate, in each case, for clauses (a) and (b), if and to the extent # Unum has access to such data and correspondence and # Unum has the right to use, and disclose such data and correspondence to SGI. All such data and related information will be the Confidential Information of Unum. The Alliance Managers will then [schedule a] meeting of the JSC as soon as reasonably practicable after completion of the Existing Phase 1 Clinical Trial or earlier, if requested by a Party. SGI will have the right to terminate this Agreement within ​ days after the date of such JSC meeting if, in the reasonable option of SGI’s senior management, the Research, Development or Commercialization of all Development Candidates and associated Products must be terminated for Safety Reasons. If SGI terminates this Agreement pursuant to this Section 16.4, then any obligation of SGI to continue to supply SGI Antibodies or of Unum to supply ACTR T-cells, or for either Party to otherwise facilitate the continued Research, Development and Commercialization of Development Candidates and associated Products, under Section 16.6(a) will be of no force or effect. For clarity, Unum may challenge any such termination as an Arbitral Matter under Article 17.

Monitoring the clinical trials and remain as key contact with the sites for the clinical trials;

“Transferred Clinical Trials” means those clinical trials of the Licensed Product which are listed in [Schedule 1.83].

recommend to the JSC whether to include any Supplemental Trials in the Late Clinical Development Plan;

Claims made in connection with any clinical trials conducted by ACADIA in relation to any Product;