Adverse Experiences. Prior to [[Organization A:Organization]] proceeding with the In-Licensing, ​ shall have responsibility (either itself or with the support of Third Party subcontractors) for communications with all Regulatory Authorities regarding the safety of the Lead Compound, including submitting or causing to be submitted to all Regulatory Authorities reports of adverse experiences and other required safety information and reports in accordance with all requirements of Applicable Laws. ​ shall provide a copy of any and all such reports and other required safety information to [[Organization A:Organization]] within […​…] after regulatory submission.

"Adverse Event" means that the Executive has experienced an event that has a material adverse impact on Executive’s job position, responsibilities, duties, authorities, compensation or opportunities within the Company. An Adverse Event shall be considered "material" under this Paragraph I.A when: # the Executive experiences any reduction in base salary; # the Executive experiences a reduction in salary range or opportunity for increases in salary; # the Executive experiences a reduction in incentive compensation range or opportunity; # there is a material reduction in the Executive’s executive benefits or perquisites; # the Executive is reassigned to a position or role with a lower salary range, salary opportunity, incentive range or incentive opportunity; or # the Executive experiences a material reduction in responsibilities.

Adverse Changes. Suffered or experienced any change in, or affecting, its condition (financial or otherwise), properties, assets, liabilities, business, operations, results of operations or prospects which would have a Material Adverse Effect;

Adverse Party. The provisions of this paragraph 9 shall not apply to any litigation or other proceeding in which you are a party adverse to the Company; provided, however, that the Company expressly reserves its rights under paragraph 7 and its attorney-client and other privileges and immunities, including, without limitation, with respect to its documents and Confidential Information, except if expressly waived in writing by Paramount’s General Counsel or his/her designee.

Adverse Claims. If at any time during the Term of this Agreement it appears that one or more private third parties may have a claim of economic interest or ownership in the Properties or the Lease Applications (or Leases acquired thereby), ALY may claim Force Majeure for a period of time equal to the time necessary to resolve such claim(s) of economic interest or ownership in the Properties or the Lease Applications (or Leases acquired thereby).

Global Safety Database. Within […​…] after [[Organization A:Organization]] proceeds with the In-Licensing, [[Organization A:Organization]] shall set up, hold, and maintain (at [[Organization A:Organization]]’s sole cost and expense, but subject to the last sentence of this subsection) the global safety database for Licensed Compounds or Licensed Products. ​ shall provide [[Organization A:Organization]] with all Information necessary or desirable for [[Organization A:Organization]] to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences, from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, Clinical Studies, and commercial experiences with a Licensed Compound or Licensed Product, in each case in the form reasonably requested by [[Organization A:Organization]].

Safety Database. The Parties shall in good faith negotiate and execute a mutually acceptable pharmacovigilance agreement addressing drug safety and adverse event reporting and compliance (the “Pharmacovigilance Agreement”) within ninety (90) days following the Effective Date. Before the execution of such Pharmacovigilance Agreement, the terms of this [Section 3.2.3] apply. Allergan shall establish, hold and maintain (at Allergan’s cost and expense) a safety database for Licensed Products. UroGen shall provide Allergan with all information necessary for Allergan to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. [sections 312.32 or 314.80]0] or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with an RTGel Product or Licensed Product. Allergan shall provide UroGen a copy of all Information maintained by Allergan in the Allergan safety database for Licensed Products or otherwise, to the extent such Information is related to RTGel Products or otherwise as necessary for UroGen to comply with Applicable Law or a request by a Regulatory Authority.

Material Adverse Change. Since September 30, 2018, there has been no change in the business, condition (financial or otherwise), operations, performance or Properties of the Company and its Subsidiaries, as reflected in the audited annual consolidated financial statements of the Company and its Subsidiaries for the fiscal year ended on such date described in [Section 6.4], which has had or could reasonably be expected to have a Material Adverse Effect.

No Adverse Selection. [[Organization C:Organization]] has not selected the Purchased Assets in a manner so as to adversely affect [[Organization B:Organization]]’s interests.

Since December 31, 2017, there shall have been no event or circumstance, either individually or in the aggregate, that has had or could reasonably be expected to have a Material Adverse Effect.