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.

Award payment 10

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.

The implementation of the Plan and the issuance of any shares of common stock under the Stock Issuance Program shall be subject to the Corporation's obtaining all approvals and permits required by regulatory authorities having jurisdiction over the Plan, and the shares of common stock issued pursuant to it.

Necessary Approvals. All foreign, federal, state and local governmental laws, rules and regulations applicable to the transactions contemplated by this Agreement and the Warrant and necessary for the execution, delivery and performance of this Agreement and the Warrant and the consummation of the transactions contemplated hereby and thereby in accordance with the terms hereof and thereof shall have been complied with, and all consents, authorizations and orders of, and all filings and registrations with, all foreign, federal, state and local courts or governmental agencies and all foreign, federal, state and local regulatory or self-regulatory agencies necessary for the execution, delivery and performance of this Agreement and the Warrant and the consummation of the transactions contemplated hereby and thereby in accordance with the terms thereof shall have been obtained or made, including, without limitation, in each case those required under the 1933 Act, the 1934 Act, applicable state securities or “Blue Sky” laws or applicable rules and regulations of the Trading Market, or otherwise required by the Commission, the Trading Market or any state or foreign securities regulators.

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.

SECTION # Governmental Approvals; No Conflicts 6759

Governmental Notices. The Ceding Company shall provide the Reinsurer, within five (5) Business Days after receipt thereof, copies of any written notice or report from any Governmental Entity directly relating to the reinsurance hereunder, other than any routine correspondence or complaints.

[[Organization B:Organization]] has made available to Cosmos a copy of each material written inspection report, questionnaire, inquiry, demand or request for information received by [[Organization B:Organization]] from (and the response of [[Organization B:Organization]] thereto), and each material written statement, report or other document filed by [[Organization B:Organization]] with, any Governmental Body since January 1, 2016.

Governmental Consent. No governmental orders, permissions, consents, approvals or authorizations are required to be obtained by the Company that have not been obtained, and no registrations or declarations are required to be filed by the Company that have not been filed in connection with, or, in contemplation of, the execution and delivery of, and performance under, the Transaction Documents, except for applicable requirements, if any, of the Securities Act, the Exchange Act or state securities laws or “blue sky” laws of the various states and any applicable federal or state banking laws and regulations.