Common use of FDA and Other Regulatory Authorities Clause in Contracts

FDA and Other Regulatory Authorities. (i) The Company holds all licenses, certificates, approvals and permits from all Israeli and United States federal and state and foreign and other regulatory authorities, including but not limited to the United States Food and Drug Administration (the “FDA”), and any foreign regulatory authorities performing functions similar to those performed by the FDA, and HC that are material to the conduct of the business of the Company or its subsidiaries as such business is now conducted as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, all of which are valid and in full force and effect and there is no proceeding pending or, to the knowledge of the Company, threatened which may cause any such license, certificate, approval or permit to be withdrawn, cancelled, suspended or not renewed. (ii) Nothing has come to the attention of the Company that has caused the Company to believe that the completed studies, tests and preclinical studies conducted by or on behalf of the Company and its subsidiaries that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus were not conducted, in all material respects, in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; or that the products used in the clinical trials have not been manufactured, in all material respects, under “current good manufacturing practices”, when required, in the United States, Israel and other jurisdictions in which such clinical trials have been and are being conducted. (iii) No filing or submission to the FDA or any other regulatory body, that was or is intended to be the basis for any approval of the Company’s products or product candidates, to the knowledge of the Company, contains any material omission or material false information. (iv) The Company is not in violation in any material respect, of any material law, order, rule, regulation, writ, injunction or decree of any court or governmental agency or body, applicable to the investigation of new drugs in humans and animals, including, but not limited to, those promulgated by the FDA.