Common use of Disclosures and Submissions to Regulatory Authorities Clause in Contracts

Disclosures and Submissions to Regulatory Authorities. As of the Effective Date, Ambit has prepared, maintained and retained all Regulatory Materials that are required to be maintained or reported pursuant to and in accordance with Applicable Law, and to Ambit’s Knowledge all such information is true, complete and correct and what it purports to be. Neither Ambit nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the development of AC220 or the Lead Product, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the development of AC220 or the Lead Product, or committed an act, made a statement, or failed to make a statement to the FDA or any other Regulatory Authority with respect to the development of AC220 or the Lead Product that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Ambit is not aware of any facts or other information that is likely to adversely affect the acceptance, or the subsequent approval, by any Regulatory Authority of any filing, application or request for Regulatory Approval, or that would otherwise materially adversely affect the scientific or therapeutic potential of AC220 or the Lead Product, provided that the representation and warranty contained in this sentence is not intended and shall not be construed to cover facts and information that Ambit can demonstrate were disclosed to Astellas in writing prior to the Effective Date.