Development and Approval Milestones. Subject to the terms of this Agreement (including Section 5.1.3), within ​ days after the first achievement by Allergan, its Affiliates or Sublicensees of a Milestone Event set forth below for Licensed Products, Allergan shall make a one-time, non-creditable, non-refundable Milestone Payment to UroGen in the amount below corresponding to such Milestone Event:

Status as Business Development Company. The Borrower is a company that has elected to be regulated as a “business development company” within the meaning of the Investment Company Act and qualifies as a RIC.

Amendments to the Development Plans. On an annual basis, or more often as the Parties deem appropriate, the JDC will prepare amendments to each then-current Early Clinical Development Plan or Late Clinical Development Plan for each Development Candidate for approval of the JSC. Each such amended Early Clinical Development Plan or Late Clinical Development Plan will specify the items described in Section 6.2(a)(i) or [Section 6.2(a)(iii)] as appropriate. Such amended Early Clinical Development Plan or Late Clinical Development Plan will cover the next calendar year (and additional periods as reasonably determined by the Parties). Such updated and amended Early Clinical Development Plan or Late Clinical Development Plan will reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to, respectively, the then-current Early Clinical Development Plan or Late Clinical Development Plan. In addition, the JDC may prepare amendments for approval by the JSC to the Early Clinical Development Plan or Late Clinical Development Plan, as appropriate, from time to time during the calendar year in order to reflect changes in such plans or budget for such calendar year, in each case, in accordance with the foregoing. Once approved by the JSC, the amended annual Early Clinical Development Plan or Late Clinical Development Plan will become effective for the applicable period on the date approved by the JSC (or such other date as the JSC will specify). Any JSC-approved amended Early Clinical Development Plan or Late Clinical Development Plan will supersede, respectively, the previous Early Clinical Development Plan or Late Clinical Development Plan for the Development Candidate for the applicable period.

Within ​ days after the end of each calendar quarter prior to the calendar quarter in which the First Commercial Sale of each Product occurs in the Shared Territory, Unum and SGI will submit to a finance officer designated by Unum and a finance officer designated by SGI (the “Finance Officers”) a report setting forth the Research Costs, Development Costs and Joint Commercialization Costs it incurred in such calendar quarter with respect to each Research Candidate, Development Candidate and Product. Each such report will specify in reasonable detail all such costs, and, if requested by Unum or SGI, any invoices or other supporting documentation for any payments to a Third Party that individually exceed ​ or with respect to which documentation is otherwise reasonably requested will be promptly provided. Within ​ Business Days after receipt of such reports, the Finance Officers will confer and agree in writing on whether a reconciliation payment is due from Unum to SGI or SGI to Unum, and if so, the amount of such reconciliation payment, so that Unum and SGI share Research Costs, Development Costs and Joint Commercialization Costs in accordance with this Agreement. Unum or SGI, as applicable, if required to pay such reconciliation payment, will submit such payment to SGI or Unum, respectively, as applicable, within ​ days of receipt of the other Party’s invoice for such amount; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within ​ Business Days after the date on which Unum and SGI, using good faith efforts, resolve the dispute. In addition, each Party will consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit each Party to close its books periodically in a timely manner. For the avoidance of doubt, no cost or expense will be counted more than once in calculating Research Costs, Development Costs and Joint Commercialization Costs, even if such cost or expense falls into more than one of the cost categories that comprise Research Costs, Development Costs and Joint Commercialization Costs.

On a Product-by-Product basis, SGI will make one-time only milestone payments to Unum based on the first achievement of the development and regulatory milestone events as set forth in this Section 11.7 for each Product.

Role of Development Project Team. The Development Project Team is intended to serve in an advisory capacity only and will not have any power to # amend, modify, interpret or waive the terms of this Agreement, including any Work Order, or # alter, increase, expand or waive compliance by a Party with a Party’s obligations, costs or expenses under this Agreement or any Work Order.

Preliminary Total Development Cost Estimate. Based upon the [[Landlord:Organization]]’s Work described in [Schedule 1] and the [[Tenant:Organization]] Improvement Allowance (defined below) for the [[Tenant:Organization]] Improvements, [[Landlord:Organization]] has prepared an estimate of the Total Development Costs (as defined in Exhibit J) for the Premises (the “Preliminary Total Development Cost Estimate”), which is set forth on [Schedule 3] attached hereto and includes detailed hard and soft cost budgets for the [[Landlord:Organization]]’s Work and the [[Tenant:Organization]] Improvement Allowance.

Initial Development Plan and Budget. Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan and Budget from time to time. Any and all such amendments shall be subject to approval by the JDC as set forth in Section 2.2.2, subject to the dispute resolution procedures set forth in Section 2.4.3.

Development Plan for Initial Indications. Prior to completion of the Initial Development Activities, the JDC shall jointly develop the Development Plan for further Development (other than Development covered by the Initial Development Plan and Budget), which will occur after [[Organization A:Organization]] proceeds with the In-Licensing, with respect to the Lead Compound for the Initial Indications. All Development activities, including any Clinical Studies, shall be designed and implemented so as to support the filing of Drug Approval Applications and the obtaining of Regulatory Approvals for the Licensed Product for the Initial Indications. Notwithstanding anything in Section 2.4 to the contrary, any disputes in the JDC regarding the details of the Development Plan will be finally determined by [[Organization A:Organization]] at its sole discretion; provided, that the inclusion of any Development activities to be performed by [[Party:Organization]] set forth in a Development Plan will require the prior written approval of [[Party:Organization]].

Unum will be primarily responsible for Development of each Development Candidate in accordance with this Agreement and the Early Clinical Development Plan for such Development Candidate during the Early Clinical Development Term.