Governmental Approvals. All requisite consents, authorizations, licenses, permits, orders, certificates and approvals of all third parties and/or governmental agencies, including without limitation any governmental agency or authority of the United States, or other

Governmental Approvals............................................................................................................ 59

Section # Governmental Approvals 11693

SECTION # Governmental Approvals 8380

SECTION # Organization; Powers; Governmental Approvals.

Agency Approvals. With respect to each Agency Approval, [[Organization C:Organization]] is in good standing, with no event having occurred or [[Organization C:Organization]] having any reason whatsoever to believe or suspect will occur, including, without limitation, a change in insurance coverage which would either make [[Organization C:Organization]] unable to comply with the eligibility requirements for maintaining all such Agency Approvals or require notification to the relevant Agency.

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.

Regulatory Approvals. Notwithstanding anything to the contrary in this Warrant Agreement, no Partnership Units will be issued or delivered upon Exercise of any Warrant unless all filings, notifications, expirations of waiting periods, waivers and approvals necessary under Antitrust Laws have been satisfied, as contemplated by Section 8(a).

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.