Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The clinical trials and pre-clinical studies conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with all applicable statutes, rules and regulations of the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studies and trials; the Company has no knowledge of any other studies or trials the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement and the Prospectus ; the Company has not received any written notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatened.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to or incorporated by reference in the Registration Statement and Statement, the Time of Sale Prospectus 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”), except where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described or referred to or incorporated by reference in the Registration Statement and Statement, the Time of Sale Prospectus or the results 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 which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable statutesexperimental protocols, rules procedures and regulations of controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory PracticesCompany; the descriptions in the Registration Statement or the Prospectus of the results of such studies do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading, and trials are accurate and complete in all material respects and fairly present the data derived from such studies and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with or otherwise reasonably call into question the results described or referred to in the Registration Statement and or the Prospectus 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”) except where failure to do so would not result in a Material Adverse Change; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension material modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatened.

Clinical Data and Regulatory Compliance. The preclinical tests, clinical trials and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, SEC Reports were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement SEC Reports; the Company has made all such filings and obtained all such approvals as may be required by the Prospectus 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 has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Time of Sale Prospectus or the Prospectus; and the Company has operated and currently in compliance in all material respects with all applicable rules, and, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and any clinical trials trials, and pre-clinical other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus 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 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 nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, andregulations and policies of the Regulatory Agencies, except for such noncompliance that would not reasonably be expected, individually or in the aggregate, to the Company’s knowledge, such termination or suspension has not been threatenedresult in a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesapproved for such studies; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are contained therein is accurate and complete in all material respects and fairly present represents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question in any material respect, the results described or referred to in the Registration Statement and or the Prospectus Prospectus; the Company and its subsidiaries have made all material filings and obtained all material 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”) to conduct the studies that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus; and, except as would not, whether individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatened.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies (collectively, “studies”) conducted by or or, to the Company’s knowledge, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”)approved for such studies, and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and presents fairly present the data derived from such studies studies, and trials; the Company has and its subsidiaries have no actual knowledge of any other studies or trials the results of which are materially inconsistent with or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Time of Sale Prospectus 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 nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesapproved for such studies; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are contained therein is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question in any material respect, the results described or referred to in the Registration Statement and or the Prospectus Prospectus; the Company and its subsidiaries have made all material filings and obtained all material 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”) to conduct the studies that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus; except as would not, whether individually or in the aggregate, reasonably be expected to result in a Material Adverse Change, neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatened.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus or incorporated by reference in, or the results of which are referred to in or incorporated by reference in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United Stateswith standard medical and scientific research procedures, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or described, referred to in the Registration Statement and the Prospectus ; the Company has not received any written notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to incorporated by reference 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, andor health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any ongoing or planned clinical trials that are described, referred to or incorporated by reference in the Company’s knowledgeRegistration 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, such termination or suspension has not been threatenedregulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials and pre-clinical studies being conducted by or on behalf of or sponsored by the Company, or in which and, to the Company has participatedknowledge of the Company, other studies (collectively, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement Statement, the Time of Sale Prospectuses or the Prospectus; the Company has made all such filings and obtained all such approvals as may be required by the Prospectus 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”); the Company has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials being conducted or pre-clinical studies sponsored by the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement 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, and, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus Supplement were and, if still pending, are are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable statutesexperimental protocols, rules procedures and regulations of controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory PracticesCompany; the descriptions in the Registration Statement or the Prospectus of the results of such studies do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading, and trials are accurate and complete in all material respects and fairly present the data derived from such studies and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with or otherwise reasonably call into question the results described or referred to in the Registration Statement and or the Prospectus Supplement; 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”) except where failure to do so would not result in a Material Adverse Change; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension material modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatenedProspectus Supplement.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement Time of Sale Document and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Final Offering Memorandum were and, if still pending, are being conducted (x) in all material respects in accordance with all applicable statuteslaws and regulations, rules including, without limitation, the Federal Food, Drug and Cosmetic Act (“FFDCA”) and its implementing regulations of the United States Food and Drug Administration (the “FDA”)at 21 C.F.R. Parts 50, 54, 56, 58, and comparable drug regulatory agencies outside of 312, and (y) except where the United Statesfailure to comply would not, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practices; the descriptions individually or in the Registration Statement aggregate, reasonably be expected to have a Material Adverse Effect, with the protocols, procedures and controls designed and approved for such studies, with standard medical and scientific research procedures, and (y) where applicable, with accepted professional and scientific standards for products or product candidates comparable to those being developed by the Prospectus Company; each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its Subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement Time of Sale Document and the Prospectus Final Offering Memorandum; 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 nor any of its Subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or Time of Sale Document and the Prospectus, Final Offering Memorandum and, to the Company’s knowledge, such termination or suspension there are no reasonable grounds for the same; 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. Except as disclosed in the Time of Sale Document and the Final Offering Memorandum, the Company has not made any knowingly false statements on, or omissions from, any applications, approvals, reports or other submissions to any Regulatory Agencies, or in or from any other records and documentation prepared or maintained to comply with the requirements of any Regulatory Agencies relating to the Company’s approved products, tentatively approved product, or product candidates. Except as disclosed in the Time of Sale Document and the Final Offering Memorandum, neither the Company nor, to the knowledge of the Company, any officer, key employee or agent of the Company has been threatenedconvicted of any crime or engaged in any conduct that would reasonably be expected to result in (a) debarment under 21 USC Section 335a or any similar state or foreign law or regulation and neither the Company nor any such person has been so debarred or excluded.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement or the Prospectus when viewed in the context in which such results are described and the Prospectus clinical stage of development; 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”), except where the failure to do so would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Change; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension material modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus 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 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 such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiary have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus Time of Sale Prospectuses or the Prospectus; the Company and its subsidiary 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”) except where the failure to make such filing or obtain such approval could not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; neither the Company nor its subsidiary has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension material modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiary have each operated and currently are in compliance in all material respects with all applicable rules, and, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols approved for such studies and in compliance in all material respects with all applicable statutes, rules and regulations of the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory PracticesHealth Care Laws; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies and trialsstudies; the Company has no knowledge made all filings and obtained all Permits 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 studies U.S. or trials foreign government drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the results of which are materially inconsistent with “Regulatory Agencies”), except where the failure to make such filing or otherwise call into question the results described obtain such Permit would not, individually or referred to in the Registration Statement and the Prospectus aggregate, have a Material Adverse Effect; the Company has not received any written notices, correspondence or other communication notice from the any Regulatory Authorities or any other governmental agency Agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or Statement, the Pricing Disclosure Package and the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatened.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, if any, and pre-clinical other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus Pricing Disclosure Package 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 nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension material modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials and pre-clinical studies being conducted by or on behalf of or sponsored by the Company and its subsidiaries, and, to the knowledge of the Company, or in which the Company has participatedother studies (collectively, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and or the Prospectus 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 nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials being conducted or pre-clinical studies sponsored by the Company or any of its subsidiaries that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statuteslaws, rules rules, regulations and regulations policies of the United States Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”)) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesor health care facility Institutional Review Board; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects respects, and fairly present the data derived from such studies and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus ; the Company has not received any written notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency requiring the termination or suspension Time of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement Sale Prospectuses or the Prospectus; for such studies that have been or are being conducted, andthe Company and its subsidiaries have made all such material filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company’s knowledge, such termination threatened to initiate, any action to place a clinical hold order on, or suspension has not been threatenedotherwise terminate or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

Clinical Data and Regulatory Compliance. The studies, tests and preclinical and clinical trials and pre-clinical studies conducted by or or, to the Company’s knowledge, on behalf of or sponsored by the Companyof, or in which the Company has participated, (the “Company Trials”) that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, were and, if still pendingongoing, are being conducted in all material respects in accordance with all applicable statutesthe protocols submitted to the FDA, rules and regulations of the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency or any foreign governmental body exercising comparable authority, and EU Member State Competent Authoritiesprocedures and controls pursuant to, to which they are subject (collectivelywhere applicable, accepted professional and scientific standards, and all Authorizations and Applicable Laws, including, without limitation, the “Regulatory Authorities”)Federal Food, including current Good Clinical Practices Drug, and Good Laboratory PracticesCosmetic Act and the rules and regulations promulgated thereunder; the descriptions of the Company Trials and the results thereof, contained in the Registration Statement or and the Prospectus of Prospectus, are, to the results of such studies and trials are Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies Company Trials; except to the extent disclosed in the Registration Statement and trials; the Prospectus, the Company has no knowledge is not aware of any other studies studies, tests or trials trials, the results of which are materially inconsistent with or otherwise the Company believes reasonably call into question the results of the Company Trials described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement and the Prospectus, the Company has not received any written notices, correspondence or other communication written notice from the Regulatory Authorities FDA, the European Medicines Agency or any other governmental agency Governmental Entity requiring the termination or suspension of any clinical trials or pre-clinical studies that are described Company Trials, other than ordinary course communications with respect to modifications in connection with the Registration Statement design and the Prospectus or the results implementation of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatenedtrials.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the CompanyCompany (collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, SEC Reports were and, if still pending, are being conducted in all material respects in accordance with all applicable statutes, rules and regulations of the United States Food and Drug Administration (the “FDA”), and comparable drug regulatory agencies outside of the United StatesHealth Care Laws, including the European Medicines Agency protocols, procedures and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices controls designed and Good Laboratory Practicesapproved for such studies; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects respects, and fairly present the data derived from such studies and trials; the Company has no knowledge of any other studies or trials studies, the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement SEC Reports; the Company has made all such filings and obtained all such approvals as may be required by the Prospectus 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 having jurisdiction over such studies (collectively, the “Regulatory Agencies”) except where the failure to make such filings or obtain such approvals would not be expected, individually or in the aggregate, to result in a Material Adverse Effect; and the Company has not received any written noticesnotice of, or written correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, such termination or suspension has not been threatenedSEC Reports.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials and pre-clinical studies that are being conducted by or on behalf the Company and, to the knowledge of or sponsored the Company, the preclinical tests and clinical trials that are being conducted by the Company’s strategic collaborators, or and that in which the Company has participated, that each case are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesprotocols, rules procedures and regulations of controls filed with the United States Food and Drug Administration (appropriate regulatory authorities for each such test or trial, as the “FDA”)case may be, and with standard accepted medical and scientific research procedures for products or product candidates comparable drug regulatory agencies outside of to those being developed by the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory PracticesCompany; the descriptions in the Registration Statement or the Prospectus of the results of such studies tests and trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies tests and trials; , and the Company has no knowledge of any other studies or tests or trials not described in the Registration Statement and the Prospectus the results of which are materially inconsistent with with, or otherwise call into question the results described or referred to in the Registration Statement and the Prospectus Prospectus; neither the Company nor any of its subsidiaries has not received any written notices, correspondence notices or other communication correspondence from the Regulatory Authorities Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other governmental U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring the termination termination, suspension or suspension material modification of any clinical tests or trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and or the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations controls designed and approved for such studies and with standard medical and scientific research procedures; provided, that with respect to any studies being conducted on behalf of or sponsored by the United States Food and Drug Administration (Company such representation is to the “FDA”), and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory PracticesCompany’s knowledge; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and or the Prospectus 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”) in connection with the conduct of such studies; neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and pre-clinical other studies conducted by or on behalf of or sponsored by the Company(collectively, or in which the Company has participated, “studies”) that are described in the Registration Statement and the Prospectus in, or the results of which are referred to in in, the Registration Statement and Statement, the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable statutesthe protocols, rules procedures and regulations of the United States Food controls designed and Drug Administration (the “FDA”), approved for such studies and comparable drug regulatory agencies outside of the United States, including the European Medicines Agency with standard medical and EU Member State Competent Authorities, to which they are subject (collectively, the “Regulatory Authorities”), including current Good Clinical Practices and Good Laboratory Practicesscientific research procedures; the descriptions in the Registration Statement or the Prospectus each description of the results of such studies and trials are is accurate and complete in all material respects and fairly present presents the data derived from such studies studies, and trials; the Company has and its subsidiaries have no knowledge of any other studies or trials the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and Statement, the Prospectus General Disclosure Package 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 comparable U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); except as disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any of its subsidiaries has not received any written noticesnotice of, or correspondence or other communication from the from, any Regulatory Authorities or any other governmental agency Agency requiring the termination termination, suspension or suspension modification of any clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package 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, to regulations and policies of the Company’s knowledge, such termination or suspension has not been threatenedRegulatory Agencies.