Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The nonclinical tests, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries 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 from any other U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); the Company and its subsidiaries have not received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical tests, Company’s clinical trials and other non-clinical studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement 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 designed and approved for such studies and with standard medical and scientific research proceduresRegulatory Agencies’ (as defined below) regulations; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries 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 FDA or from any other U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) or any health care facility Institutional Review Board (“IRB”); neither the Company and nor any of its subsidiaries have not has received any notice of, or correspondence from, any Regulatory Agency or IRB requiring the termination or suspension of any clinical trials that are described or referred to in the Registration Statement 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 and regulations of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries does not have no any knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; SEC Reports. Each of the Company and its subsidiaries have has 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”)) based on the location and nature of the relevant study; the Company and its subsidiaries have has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement or the ProspectusSEC Reports; and each of the Company and its subsidiaries have has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical preclinical tests, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each . Each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the SEC Reports. The Company and its subsidiaries Subsidiaries 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 non-U.S. government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); . Neither the Company and nor any of its subsidiaries have not Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; SEC Reports and the are currently being conducted. The Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus SEC Documents were and, if still pending, are being conducted in all material respects in accordance with the applicable protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, would reasonably contradict the results described or referred to in the Registration Statement or the ProspectusSEC Documents; the Company and its subsidiaries have made all such required filings and obtained all such necessary approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any regulatory authority thereof or from any other U.S. or foreign government or drug regulatory agency, or health care facility authority, including Institutional Review Board Board, (collectively, the “Regulatory Agencies”); neither the Company and nor any of its subsidiaries have not has received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension material restriction of any clinical trials that are described or referred to in the Registration Statement or the ProspectusSEC Documents; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the ProspectusSEC Reports; the Company and its subsidiaries 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 non-U.S. government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company and nor any of its subsidiaries have not has received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement or the ProspectusSEC Reports; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, contradict the clinical results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company and nor any of its subsidiaries have not has received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement 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, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical preclinical tests, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus SEC Reports were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the ProspectusSEC Reports; the Company and its subsidiaries have has 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 regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”)) except where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Event; the Company and its subsidiaries have has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have has operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for that apply to such studies and with standard customary medical and scientific research procedurespractices; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such necessary filings and obtained all such approvals or authorizations as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or from by any other analogous U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”)) to conduct such studies; neither the Company and nor its subsidiaries have not received any written notice of, or correspondence from, from any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement 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 and regulations of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The nonclinical testspreclinical tests and clinical trials, clinical trials and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have has 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”)) based on the location and nature of the relevant study; the Company and its subsidiaries have has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies.