Common use of Research and Development Efforts Clause in Contracts

Research and Development Efforts. 7.4.1 Company shall use its commercially reasonable efforts to conduct such research, development and preclinical and human clinical trials as Company reasonably determines are necessary or desirable to obtain regulatory approval to manufacture and market such Products as Company reasonably determines are commercially feasible in the Field, and shall use its commercially reasonable efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Product in such countries in the Territory as Company reasonably determines are commercially feasible. The parties acknowledge that the Development Plan attached hereto as Exhibit B represents the optimal and mutually desired timeline for development of the Technology and Products and is subject to change following the Effective Date. 7.4.2 Without limiting the generality of Section 7.4.1, Company, its Affiliate or its Sublicensee shall satisfy each of the following development milestones (each a “Development Milestone”): (a) Onset of a Phase II Clinical Trial for the Oral Formulation Product within nine (9) months of Effective Date; (b) [*]; (c) [*]; (d) [*]; 7.4.3 Without prejudice to any remedies as provided in this Agreement and appropriate laws, in the event Company, its Sublicensee or their respective Affiliates fails to achieve a Development Milestone, and such failure was not due to reason(s) beyond their reasonable control, Licensor shall have the right to terminate this Agreement. For the avoidance of doubt and without prejudice to other reasons that may be deemed beyond the reasonable control of Company, its Sublicensee or their respective Affiliates, should the failure to achieve a Development Milestone be caused by (a) a requirement by the FDA or other Competent Authority that Company, its Sublicensee or their respective Affiliates perform additional studies or trials, that Company, its Sublicensee or their respective Affiliates reformulate or alter the manufacturing process of any Product, that Company, its Sublicensee or their respective Affiliates cease any clinical trial or redesign any clinical trial, or that Company, its Sublicensee or their respective Affiliates perform any other action or cease to perform any action that otherwise delays the clinical development of any Product; or (b) the inability to procure, manufacture or have manufactured GMP-grade clinical or commercial supplies due to factors beyond the reasonable control of Company, its Sublicensee or their respective Affiliates, then such evidence presented to Licensor by Company, its Sublicensee or their respective Affiliates shall be deemed by Licensor to be beyond the reasonable control of Company, its Sublicensee or their respective Affiliates, and Company, its Sublicensee or their respective Affiliates automatically shall be granted reasonable time extensions or milestone adjustments to the extent of any such delay (the “Excused Delay”). 7.4.4 If Company, its Sublicensee or their respective Affiliates fails to achieve a Development Milestone, taking into account any Excused Delay to which Company, its Sublicensee or their respective Affiliates may be entitled, then Licensor shall grant to Company, its Sublicensee or their respective Affiliates additional time in which to achieve such Development Milestone subject to the payment to Licensor of [*] Dollars ($[*]) for each of the first two three (3) month extension periods (“Extension Periods”), and subject to the payment to Licensor of [*] Dollars ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates, and subject to the payment to Licensor of [*] ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates. Licensor shall have no obligation to grant more than [*] ([*]) Extension Periods.

Research and Development Efforts. 7.4.1 Company 7.1.1 Licensee shall use its commercially reasonable efforts to conduct such research, development and preclinical and human clinical trials as Company Licensee reasonably determines are necessary or desirable to obtain regulatory approval to manufacture and market such Products as Company reasonably Licensee determines are commercially feasible in the Field, and shall use its commercially reasonable efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Product in such countries in the Territory as Company Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. Licensee reasonably determines are commercially feasible. The parties acknowledge that the Development Plan attached hereto as Exhibit B D (the "Development Plan") represents the optimal and mutually desired timeline for development of the Technology and Products and is subject to change following the Effective Date, including following Licensee's initial meeting with the FDA regarding development of Product. 7.4.2 7.1.2 Without limiting the generality of Section 7.4.17.1.1, CompanyLicensee, its Affiliate or its Sublicensee shall satisfy each of the following development milestones (each a “"Development Milestone”"): (a) Onset of a Phase II Clinical Trial for the Oral Formulation Product within nine (9) months of Effective Date[***]; (b) [***]; (c) [***];; and (d) [***];. 7.4.3 Without prejudice to any remedies as provided in this Agreement and appropriate laws, in 7.1.3 In the event CompanyLicensee, its Sublicensee or their respective Affiliates fails to achieve a Development Milestone, and such failure was not due to reason(s) beyond their reasonable control, Licensor shall have the right to terminate this AgreementAgreement (except that Licensor may not terminate this Agreement for failure to meet the milestone set forth in sub­ Section 7.1.2 (a) if Licensee has made the specified milestone payment and is continuing to use its commercially reasonable efforts to complete [***] as soon thereafter as practicable). For the avoidance of doubt and without prejudice to other reasons that may be deemed beyond the reasonable control of CompanyLicensee, its Sublicensee Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission. or their respective Affiliates, should the failure to achieve a Development Milestone be caused by (a) a requirement by the FDA or other Competent Authority that Company, its Sublicensee or their respective Affiliates perform additional studies or trials, that Company, its Sublicensee or their respective Affiliates reformulate or alter the manufacturing process of any Product, that Company, its Sublicensee or their respective Affiliates cease any clinical trial or redesign any clinical trial, or that Company, its Sublicensee or their respective Affiliates perform any other action or cease to perform any action that otherwise delays the clinical development of any Product; or (b) the inability to procure, manufacture or have manufactured GMP-grade clinical or commercial supplies due to factors beyond the reasonable control of Company, its Sublicensee or their respective Affiliates[***], then Licensee shall present such evidence presented to Licensor by Company, its Sublicensee or their respective Affiliates and the delay shall be deemed by Licensor to be beyond the reasonable control of CompanyLicensee, its Sublicensee or their respective Affiliates, and CompanyLicensee, its Sublicensee or their respective Affiliates automatically shall be granted reasonable time extensions or milestone adjustments to the extent of any such delay (the “"Excused Delay”"). 7.4.4 If Company, its Sublicensee or their respective Affiliates fails to achieve a Development Milestone, taking into account any Excused Delay to which Company, its Sublicensee or their respective Affiliates may be entitled, then Licensor shall grant to Company, its Sublicensee or their respective Affiliates additional time in which to achieve such Development Milestone subject to the payment to Licensor of [*] Dollars ($[*]) for each of the first two three (3) month extension periods (“Extension Periods”), and subject to the payment to Licensor of [*] Dollars ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates, and subject to the payment to Licensor of [*] ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates. Licensor shall have no obligation to grant more than [*] ([*]) Extension Periods.

Research and Development Efforts. 7.4.1 Company 7.1.1 UroGen shall use its commercially reasonable efforts (a) to conduct such research, development and preclinical and human clinical trials as Company reasonably determines are necessary or desirable to obtain all regulatory approval approvals to manufacture and market Licensed Products and practice Licensed Methods for use in the Field, (b) to obtain necessary approval to market Licensed Products and practice Licensed Methods for use in the Field in the United States and in such other countries as UroGen determines to be commercially feasible, (c) to commence marketing as soon as reasonably practicable after approval, and market, Licensed Products as Company reasonably determines are commercially feasible for use in the Field, and shall use its commercially reasonable efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Product in such countries in the Territory as Company reasonably determines are commercially feasible. The parties acknowledge that the Development Plan attached hereto as Exhibit B represents the optimal and mutually desired timeline for development of the Technology and Products and is subject to change following the Effective Date. 7.4.2 Without limiting the generality of Section 7.4.1, Company, its Affiliate or its Sublicensee shall satisfy each of the following development milestones (each a “Development Milestone”): (a) Onset of a Phase II Clinical Trial for the Oral Formulation Product within nine (9) months of Effective Date; (b) [*]; (c) [*]; (d) [*];to market such Licensed Products and practice Licensed Methods in sufficient quantities to meet the reasonably foreseeable market demands therefor. 7.4.3 Without prejudice 7.1.2 On or before ▇▇▇▇▇ ▇▇, ▇▇▇▇, ▇▇▇▇▇▇ shall submit to any remedies as provided in this Agreement IRC a research and appropriate lawsdevelopment plan with diligence milestones, in form and content reasonably acceptable to IRC, for the commercialization of Licensed Products. IRC shall not unreasonably withhold such approval. Upon receiving the approval of IRC, the diligence milestones pertaining to the Field will be automatically incorporated into this Section 7.1.2 by this reference. In the event Company, its Sublicensee or their respective Affiliates UroGen fails to achieve a Development Milestonematerially perform its obligations under this Section 7.1, and such failure was not due to reason(s) beyond their reasonable control, Licensor shall have IRC has the right and option to terminate this Agreement. For To exercise this right to terminate the avoidance Agreement, IRC must give UroGen written notice of doubt UroGen's deficiency in achieving the diligence milestones. UroGen thereafter has ninety (90) days to cure the deficiency, or to submit for approval by IRC, which approval will not be unreasonably withheld, a plan to cure such deficiency as soon as is feasible (if such deficiency cannot be cured within ninety (90) days). If IRC does not receive within the ninety (90) days either satisfactory tangible evidence that UroGen has cured the deficiency or a written plan for curing the deficiency, then IRC may, at its option, terminate this Agreement by giving written notice to UroGen. 7.1.3 Within ninety (90) days after the date of the Agreement, UroGen shall enter into an agreement with ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Cancer Center ("SKCC") to conduct certain research and without prejudice clinical development in the field of prostate cancer (pursuant to other reasons that may be deemed beyond the reasonable control of Company, its Sublicensee or their respective Affiliates, should the failure to achieve a Development Milestone be caused by (a) a requirement by the FDA or other Competent Authority that Company, its Sublicensee or their respective Affiliates perform additional studies or trials, that Company, its Sublicensee or their respective Affiliates reformulate or alter the manufacturing process of any Product, that Company, its Sublicensee or their respective Affiliates cease any research plan and clinical trial or redesign any clinical trial, or protocol reasonably acceptable to both parties. The parties each acknowledge that Company, its Sublicensee or their respective Affiliates perform any other action or cease to perform any action that otherwise delays the clinical development of any Product; or (b) the inability to procure, manufacture or have manufactured GMP-grade clinical or commercial supplies due to factors beyond the reasonable control of Company, its Sublicensee or their respective Affiliates, then such evidence presented to Licensor by Company, its Sublicensee or their respective Affiliates shall be deemed by Licensor plan will allow for certain activities to be beyond the reasonable control performed outside of Company, its Sublicensee or their respective Affiliates, and Company, its Sublicensee or their respective Affiliates automatically SKCC. UroGen shall be granted reasonable time extensions or milestone adjustments to the extent of any such delay (the “Excused Delay”). 7.4.4 If Company, its Sublicensee or their respective Affiliates fails to achieve a Development Milestone, taking into account any Excused Delay to which Company, its Sublicensee or their respective Affiliates may be entitled, then Licensor shall grant to Company, its Sublicensee or their respective Affiliates additional time in which to achieve such Development Milestone subject to the payment to Licensor of [*] Dollars expend not less than one hundred thirty thousand dollars ($[*]130,000) for each of funding the first two three (3) month extension periods (“Extension Periods”)work described in the plan, and subject including but not limited to the payment funds paid to Licensor of [*] Dollars ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates, and subject to the payment to Licensor of [*] ($[*]) for each of the next two Extension Periods that is requested by Company, its Sublicensee or their respective Affiliates. Licensor shall have no obligation to grant more than [*] ([*]) Extension PeriodsSKCC.