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. The permits, approvals and consents of all Governmental Entities described in [Schedule 4.4] that are required for the execution, delivery or performance of this Agreement by ​.

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;