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

Governmental Approvals. No authorization, consent, approval, license, exemption or other action by, and no registration, qualification, designation, declaration or filing with, any Governmental Authority (other than filings under the Securities Exchange Act of 1934, as amended, and the rules and regulations of the SEC promulgated thereunder) is necessary in connection with Howmet’s execution and delivery of this Amendment, the consummation by Howmet of the transactions contemplated hereby or Howmet’s performance of or compliance with the terms and conditions hereof or of the Credit Agreement as modified hereby.

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

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.

Award payment 10

Governmental Approvals. No authorization or approval or other action by, and no notice to or filing with, any Governmental Authority is required in connection with the due execution, delivery and performance by any Loan Party of any Loan Document to which it is or will be a party.

Governmental Approvals. Any material Governmental Approval shall have been # revoked, rescinded, suspended, modified in an adverse manner or not renewed in the ordinary course for a full term or # subject to any decision by a Governmental Authority that designates a hearing with respect to any applications for renewal of any of such material Governmental Approval or that could result in the Governmental Authority taking any of the actions described in [clause (a) above], and such decision or such revocation, rescission, suspension, modification or non-renewal # cause, or could reasonably be expected to cause, a Material Adverse Change, or # adversely affects the legal qualifications of a Co-Borrower or any of its Subsidiaries to hold such material Governmental Approval in any applicable jurisdiction and such revocation, rescission, suspension, modification or non-renewal could reasonably be expected to affect the status of or legal qualifications of a Co-Borrower or any of its Subsidiaries to hold any material Governmental Approval in any other jurisdiction.

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. 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.