Governmental Approvals. All the Consents of the Governmental Authorities set forth on Section 8.1(b) of the Permal Disclosure Schedule and Section 8.1(b) of the EnTrust Disclosure Schedule shall have been obtained.

Regulatory Approvals. As between the Parties, except as expressly set forth herein, Allergan shall have the sole right to prepare, obtain, and maintain Drug Approval Applications and BLAs, as applicable (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, and other submissions to Regulatory Authorities, and to conduct communications with the Regulatory Authorities, for Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities with respect to Development activities). Allergan shall provide UroGen with copies of relevant draft modules (or their equivalent) of original marketing applications (for clarity, excluding amendments to marketing applications) for any Licensed Product in the Territory reasonably in advance of such application’s submission. UroGen may provide comments on such application’s content within ​ Business Days of receipt, and Allergan shall consider UroGen’s comments in good faith to the extent applicable to the RTGel Component. UroGen shall support Allergan, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents and other materials in the possession or control of UroGen or any of its Affiliates, and attending any meeting or discussion with any Regulatory Authority, in either case, as may be necessary or useful for Allergan or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products. In addition, ​ and ​. Allergan shall provide UroGen with minutes of any meeting with a Regulatory Authority relating to the RTGel Component; provided, that Allergan may redact from such minutes any Information that pertains to products other than a Licensed Product. For purposes of this Section 3.2.1, “Notified Body”, means the certification organization designated by the relevant member state of the European Union, authorized to conduct conformity assessments in accordance with the procedures listed in the European Union Directive, 93/42/EEC (OJ No L 169/1, 12 July 1993), as amended. Upon UroGen’s request, Allergan shall promptly provide UroGen with all documents ​ in accordance with this Section 3.2.1.

Governmental Approvals. The execution, delivery and performance of each Loan Document do not require any consent or approval of, registration or filing with, or other action by, any Governmental Authority, except for # such as have been obtained or made and are in full force and effect, # as may be required to perfect the Collateral Agent’s security interests granted pursuant to the Collateral Documents, # such consents, approvals, registrations, filings or actions the failure of which to obtain or make would not reasonably be expected to have a Material Adverse Effect and # as disclosed in the Preliminary Offering Memorandum.

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 the Company’s General Counsel or his/her designee.

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 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).

Except as set forth in [Schedule 5.6], # no consent, approval or authorization of, or declaration, filing or registration with, any governmental body is required for the execution, delivery and performance by the Company of this Agreement and the Transaction Documents to which it is a party or for the consummation by the Company of the transactions contemplated hereby and thereby and # no consent, approval or authorization of any third party is required for the execution, delivery and performance by the Company of this Agreement and the Transaction Documents to which it is a party and the consummation by the Company of the transactions contemplated hereby and thereby.

Authorization, Compliance, Approvals. The execution and delivery of, and the performance by [[Organization C:Organization]] of its obligations under, the Program Documents to which it is a party # are within [[Organization C:Organization]]’s powers, # have been duly authorized by all requisite action, # do not violate any provision of applicable law, rule or regulation, or any order, writ, injunction or decree of any court or other Governmental Authority, or its organizational documents, # do not violate any indenture, agreement, document or instrument to which [[Organization C:Organization]] or any of its Subsidiaries is a party, or by which [[Organization C:Organization]] or any of [[Organization C:Organization]]’s properties, any of the Repurchase Assets is bound or to which any of them is subject and # are not in conflict with, do not result in a breach of, or constitute (with due notice or lapse of time or both) a default under, or except as may be provided by any Program Document, result in the creation or imposition of any Lien upon any of the property or assets of [[Organization C:Organization]] or any of its Subsidiaries pursuant to, any such indenture, agreement, document or instrument. [[Organization C:Organization]] is not required to obtain any consent, approval or authorization from, or to file any declaration or statement with, any Governmental Authority in connection with or as a condition to the consummation of the Transactions contemplated herein and the execution, delivery or performance of the Program Documents to which it is a party.

Consents and Approvals. Each EnTrust Entity # shall have made all filings or declarations, provided all notices, obtained all authorizations, consents, waivers, approvals or exemptions, and taken all other actions required to be made, provided, obtained or taken by such EnTrust Entity to consummate the Transactions, in each case, as set forth on Section 8.2(e) of the EnTrust Disclosure Schedule and # shall have delivered true, complete and correct copies of such filings, declarations, notices, authorizations, consents, waivers, approvals, exemptions and evidence of such other actions to the Permal Contributor.