Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical 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 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 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, the Time of Sale Prospectuses or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any 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 has operated and currently is 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, and other studies (collectively, “studies”) 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 are, to the Company’s knowledge, 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 proceduresstudies; each description of the results of such studies is is, to the Company’s knowledge, accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company 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, the Time of Sale Prospectuses or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would as could not be reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any 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 has operated and currently is 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, 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 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 has 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the such failure to make such filing or obtain such approval non-compliance would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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 Company’s clinical and non-clinical 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 study protocols submitted to the U.S. Food and controls designed and approved for such studies and Drug Administration (“FDA”) and/or with standard medical and scientific research proceduresapplicable FDA 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 has 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, the Time of Sale Prospectuses or the Prospectus; the Company has and its Subsidiaries have made all such 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 FDA or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) or any health care facility Institutional Review Board (“IRB”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its Subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency or IRB requiring the termination, termination or suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Preliminary Prospectus or the Prospectus; and the Company has and its Subsidiaries have each operated and currently is 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 conducted or being conducted by or at the direction of the Company (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 designed and approved for such studies and with standard medical all applicable local, state and scientific research proceduresfederal laws, rules and regulations, including the Federal Food, Drug, and Cosmetic Act and its implementing regulations; each description in the Registration Statement, the Time of Sale Prospectus and the Prospectus of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studiesstudies in all material respects, and to the Company has Company’s knowledge, there are no knowledge of any other studies the results of which are materially inconsistent with, with or otherwise call into question, question in any material respect the results described or referred to in the Registration Statement, the Time of Sale Prospectuses Prospectuses, or the Prospectus; the Company has made all such filings and obtained all such approvals or authorizations Permits as may be required to be made or obtained by the Company by the Food and Drug Administration of the U.S. Department of Health and Human Services or from by any other applicable U.S. or foreign government or governmental drug or medical device regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”), except where the failure to make any such filing or obtain any such approval Permit would not reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except other than as described in the Registration Statement, the Time of Sale Prospectus and or the Prospectus, the Company has not received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any clinical trials conducted or being conducted by or at the direction of the Company that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has operated and currently is 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, 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 Pricing Disclosure Package 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 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, the Time of Sale Prospectuses Pricing Disclosure Package or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package and the Prospectus, the Company has not received any 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 Pricing Disclosure Package or the Prospectus; and the Company has operated and currently is 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 studies and clinical 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 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 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, the Time of Sale Prospectuses or the Prospectus; where required, the Company has made all such filings and obtained all such approvals or authorizations as may be required by the Food and Drug Administration (the “FDA”) 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or 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 ProspectusProspectus that has not been remediated; and the Company has operated and currently is 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, 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 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 has 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectuses Prospectus or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the such failure to make such filing or obtain such approval non-compliance would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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, 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 Statement or the Prospectus were and, if still pending, are are, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures and controls designed and approved for such studies and with standard medical pursuant to, where applicable, accepted professional and scientific research proceduresstandards for products or product candidates comparable to those being developed by the Company; each description the descriptions of the results of such studies is accurate and complete in all do not contain any misstatement of a material respects and fairly presents the data derived from fact or omit to state a material fact necessary to make such studiesstatements not misleading, and the Company has and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, the Time of Sale Prospectuses Statement or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), ) except where the failure to make such filing or obtain such approval do so would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 Statement or the Prospectus; and the Company has operated and currently is 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, 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 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 has 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectuses Statement or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the such failure to make such filing or obtain such approval non-compliance would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 or incorporated by reference in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus were and, if still pending, are are, to the Company’s knowledge, 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 proceduresstudies; each description of the results of such studies is to the Company’s knowledge accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company 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, the Time of Sale Prospectuses Prospectuses, the Prospectus or the Canadian Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would as could not be reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any 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, the Prospectus or the Canadian Prospectus; and the Company has operated and currently is 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, and other studies (collectively, “studies”) 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 are, to the Company’s knowledge, 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 proceduresstudies; each description of the results of such studies is is, to the Company’s knowledge, accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has 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, the Time of Sale Prospectuses or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the failure to make such filing or obtain such approval would as could not be reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 has and its subsidiaries have operated and currently is 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, and other studies trials (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Pricing 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 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 has no knowledge as of the date hereof 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, the Time of Sale Pricing Prospectuses or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would could not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except such as are described in the Registration Statement, the Time of Sale Pricing Prospectus and the Prospectus, the Company has not received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus; and the Company has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as otherwise disclosed in the Disclosure Documents, the preclinical tests and clinical trials, and other studies conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws, including the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studiesrespects, and the Company has no knowledge of any other studies studies, 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 Statement or the Prospectus; the Company has made all such 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 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 having jurisdiction over such studies (collectively, the “Regulatory Agencies”), ) except where the failure to make such filing filings or obtain such approval approvals would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any written notice of, or written correspondence from, any Regulatory Agency requiring the termination, termination or suspension or material modification of any clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company has operated and currently is 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, and other studies trials (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 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 has no knowledge as of the date hereof 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, the Time of Sale Prospectuses or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would could not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except such as are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or 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 has operated and currently is 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, and other studies (collectively, “studies”) 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 are, to the Company’s knowledge, 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 proceduresstudies; each description of the results of such studies is is, to the Company’s knowledge, accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has 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, the Time of Sale Prospectuses Prospectus or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the failure to make such filing or obtain such approval would as could not be reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 has and its subsidiaries have operated and currently is 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 studies and clinical 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 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 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, the Time of Sale Prospectuses or the Prospectus; where required, the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or 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 ProspectusProspectus that has not been remediated; and the Company has operated and currently is 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, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus were and, if still pending, are are, to the Company’s knowledge, 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 proceduresstudies; each description of the results of such studies is is, to the Company’s knowledge, accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company 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, the Time of Sale Prospectuses Prospectuses, the Prospectus or the Canadian Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would as could not be reasonably be expected toexpected, individually or in the aggregate, result in to have a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any 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, the Prospectus or the Canadian Prospectus; and the Company has operated and currently is 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, 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 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 has and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration Statement, the Time of Sale Prospectuses Statement or the Prospectus; the Company has and its subsidiaries have made all such 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 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”)) , except where the failure to make such filing or obtain such approval do so would not reasonably be expected tonot, individually singly or in the aggregate, reasonably be expected to result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 Statement or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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, 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 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 has 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, the Time of Sale Prospectuses Statement or the ProspectusProspectus when viewed in the context in which such results are described and the clinical stage of development; the Company has and its subsidiaries have made all such 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 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”), except where the failure to make such filing or obtain such approval do so would not reasonably be expected tonot, individually singly or in the aggregate, reasonably be expected to result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 Statement or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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, and other studies conducted or sponsored by the Company (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 all applicable Health Care Laws, including the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studiesrespects, and the Company has no knowledge of any other studies studies, 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; the Company has made all such 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 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 having jurisdiction over such studies (collectively, the “Regulatory Agencies”), ) except where the failure to make such filing filings or obtain such approval approvals would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse EffectChange; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any written notice of, or written correspondence from, any Regulatory Agency requiring the termination, termination or suspension or material modification of any clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has operated and currently is 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 studies and clinical trials, and other studies (collectively, “studies”) 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 the protocols, procedures and controls designed and approved for such clinical trials and studies and with standard medical and scientific research procedures; each description of the results of such clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such clinical trials and studies, and the Company has and its subsidiaries have no knowledge of any other clinical trials or studies 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; the Company has and its subsidiaries have made all such filings and obtained all such approvals or authorizations as may be required by the U.S. 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 or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the types of products being developed by the Company (collectively, the “Regulatory Agencies”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not 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 has and its subsidiaries have each operated and currently is 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 studies and clinical 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 designed and approved for such clinical trials and studies and with standard medical and scientific research procedures; each description of the results of such clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such clinical trials and studies, and the Company has and its subsidiaries have no knowledge of any other clinical trials or studies 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; the Company has and its subsidiaries have made all such filings and obtained all such approvals or authorizations as may be required by the U.S. 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 or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the types of products being developed by the Company (collectively, the “Regulatory Agencies”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not 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 has and its subsidiaries have each operated and currently is 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, 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 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 has and its subsidiaries have 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, the Time of Sale Prospectuses Statement or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the failure to make have made such a filing or obtain such approval would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse EffectChange; except as described disclosed in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, within the last five years, neither the Company nor any of its subsidiaries has not received any 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 Statement or the Prospectus; and the Company has and its subsidiaries have each operated and currently is 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, 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 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 has 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, the Time of Sale Prospectuses or the Prospectus; the Company has and its subsidiaries have made all such 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 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”), except where the such failure to make such filing or obtain such approval non-compliance would not reasonably be expected toexpected, individually or in the aggregate, to result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has not received any 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 has and its subsidiaries have each operated and currently is 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, and other studies (collectively, “studies”) that are described or incorporated in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus 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 has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or incorporated in or referred to in the Registration Statement, the Time of Sale Prospectuses Statement or the Prospectus; the Company has and its Subsidiaries have made all such 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 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, neither the Company nor any of its Subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or incorporated in or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and each of its Subsidiaries has operated and currently is 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 trialstrials being conducted or sponsored by the Company, and and, to the knowledge of the Company, 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 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 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, the Time of Sale Prospectuses or the Prospectus; the Company has made all such 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 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”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials being conducted or sponsored by the Company that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.