Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or trial, as the case may be, and with standard medical and scientific research procedures; each description of the results of such tests and trials contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus is accurate and complete in all material respects and fairly presents in all material respects the data derived from such tests and trials, and the Company and its subsidiaries have no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; neither the Company nor any of its subsidiaries has received any notices or other correspondence from the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials that are conducted by the Company, and to the knowledge of the Company the clinical trials conducted by third parties, in each case described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, protocols and procedures and controls filed with the appropriate regulatory authorities for each such test or trial, as the case may be, and with standard medical and scientific research procedures; each description of the results of such preclinical tests and clinical trials contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus is accurate and complete in all material respects and fairly presents in all material respects the data derived from such preclinical tests and clinical trials, and the Company and its subsidiaries have no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; neither the Company nor any of its subsidiaries has received any notices or other correspondence from the United States Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency with jurisdiction over the products being developed by the Company (collectively, the “Regulatory Agencies”) requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, rules and regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls filed with the appropriate regulatory authorities designed and approved for each such test or trial, as the case may be, studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such tests and trials contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus studies is accurate and complete in all material respects and fairly presents in all material respects the data derived from such tests and trialsstudies, and the Company and its subsidiaries have no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses Prospectus or the Prospectus; neither the Company nor any of and its subsidiaries has received any notices or other correspondence from have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) ); neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, rules and regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies (collectively, “studies”) being conducted by the Company, that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls filed with the appropriate regulatory authorities designed and approved for each such test or trial, as the case may be, studies and with standard medical and scientific research proceduresprocedures and the applicable laws, rules and regulations of the Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”); each description of the results of such tests and trials contained in the Registration Statement, the Time of Sale Prospectus or the Prospectus studies is accurate and complete in all material respects and fairly presents in all material respects the data derived from such tests and trialsstudies, and the Company and its subsidiaries have has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses Prospectus or the Prospectus; neither the Company nor any and its Subsidiary have made all such filings and obtained all such approvals as may be required by the Israeli Ministry of its subsidiaries has received any notices or other correspondence from Health, the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof or from any other U.S. U.S., Israeli or foreign government or drug or medical device regulatory agency agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) ); neither the Company nor its Subsidiary has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries Subsidiary have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.