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.

Material Adverse Change. A material adverse change occurs, or is reasonably likely to occur, in [[Organization A:Organization]]’s (or any guarantor’s) business condition (financial or otherwise), operations, properties or prospects, or ability to repay the credit.

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 Change. There have been no material adverse changes to the financial condition, results of operations, business or prospects of the Company.

Material Adverse Change. A Material Adverse Change occurs;

Material Adverse Change. There shall have been no Material Adverse Change. The income and expenses of each Property, the occupancy thereof, and all other features of the transaction shall be as represented to the Agent without material adverse change. Neither the Borrowers nor any of their constituent Persons shall be the subject of any bankruptcy, reorganization, or insolvency proceeding.

No Material Adverse Change. There shall not have been any occurrence, event, incident, action, failure to act, or transaction since August 31, 2018 which has had or is reasonably likely to cause a ​ Material Adverse Effect.

No Material Adverse Change. None of the following shall have occurred and be continuing:

Required Approvals. All terminations or expirations of waiting periods imposed (and any extension thereof) by any Governmental Authority under the Competition Laws shall have expired or been terminated and all required Permits under the Competition Laws shall have been made and obtained.

Regulatory Approvals. Graphite will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Graphite's use of any Product Developed and/or Manufactured under this Agreement, including investigational new drug application, biologics license application, new drug application, and abbreviated new drug application submissions in the United States and any analogous submissions filed with the appropriate authority of a country other than the United States. In accordance with the scope and terms of the applicable Work Order, WuXi ATU will provide Graphite or the Regulatory Authority either directly or through access to WuXi ATU’s applicable drug master file(s) (DMFs) with appropriate supporting chemistry, manufacturing, and control (CMC) data and information relating to the Development and/or Manufacture of Product by WuXi ATU to the extent required for such approvals

Market Approvals. TLC Hong Kong shall be responsible for obtaining all relevant Market Approvals at its cost in the China Territory for the TLC Products. TLC Hong Kong will, at its expense, maintain the Market Approvals in the China Territory, TLC shall have the right of reference to such Market Approvals for the purpose of seeking, obtaining and maintaining regulatory approvals for the TLC Product in and outside the China Territory or for Commercialization of the TLC Product outside the China Territory.

Governmental Approvals. The Parties acknowledge that if TLC’s performance of any obligations under this Agreement requires any applicable governmental approval, TLC will not be deemed in breach for failure to perform that obligation until receipt of the necessary governmental approvals. TLC will use its best efforts to obtain such approvals when required.

Governmental Approvals. No authorization or approval or other action by, and no notice to or filing with, any Governmental Authority is required for the due

Governmental Approvals. No authorization or approval or other action by, and no notice to or filing with, any Governmental Authority or regulatory body is required for the due execution, delivery and performance by Borrower of any Loan Documents, except for such approvals and consents which have been made or obtained.

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Regulatory Approvals. The Required Regulatory Approvals shall have been duly obtained, and such approvals shall have become Final Orders or, if applicable, any mandatory waiting period prescribed by Law before the transactions contemplated hereby may be consummated shall have expired or been terminated.

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, ​), as amended. Upon UroGen’s request, Allergan shall promptly provide UroGen with all documents ​ in accordance with this [Section 3.2.1].