Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and 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 in all material respects, and the Company 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 General Disclosure Package or the Prospectus; except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, 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 Governmental Entities.

Clinical Data and Regulatory Compliance. All nonclinical studies and clinical trials conducted by or on behalf of the Company or any company from which the Company acquired the rights to any product that are material to the Company and its Subsidiaries, taken as a whole, are or have been adequately described in the Registration Statement, the Pricing Disclosure Package and the Prospectus in all material respects. The clinical trials, trials and other nonclinical studies (collectively, “studies”) conducted by or on behalf of the Company and its Subsidiaries that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus were and, if still pendingongoing, are being conducted in material compliance with all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description regulations applicable thereto in the jurisdictions in which they were or are being conducted and with all laws and regulations applicable to any such studies or trials from which data will be submitted to support marketing approval. The descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies is and trials are accurate and complete in all material respects and fairly presents present the data derived from such studies in all material respectsand trials, and the Company and its subsidiaries have has no knowledge of, or reason to believe that, any large well-controlled clinical trial the aggregate results of which are inconsistent with or otherwise call into question the results of any other studies clinical trial or post-market study conducted by or on behalf of the Company that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus; except . Except as disclosed in the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid ServicesEuropean Medicines Agency (“EMA”), and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyagency (collectively, or by any Institutional Review Board; neither the “Regulatory Agencies”). Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company nor any of its subsidiaries has not received any written notice ofnotices or or other communication from any Regulatory Agency imposing, requiring, requesting or correspondence fromsuggesting a clinical hold, any Governmental Entity requiring the termination, suspension or material modification for or of any clinical trials or nonclinical studies that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus; and, except . Except as disclosed in the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, the Company has not received any written notices or other communications from any Regulatory Agency, and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rulesotherwise has no knowledge of, regulations and policies or reason to believe that, (i) any product approval application for a potential product of the Governmental EntitiesCompany is or has been rejected or determined to be non-approvable or conditionally approvable; or (ii) any license, approval, permit or authorization for a product of the Company has been, will be or may be suspended, revoked, modified or limited.

Clinical Data and Regulatory Compliance. The clinical trialsCompany and its subsidiaries have operated and currently are in compliance with all applicable rules, regulations and other studies policies of the U.S. Food and Drug Administration and applicable foreign regulatory authorities (collectively, the “studiesRegulatory Authorities”) in all material respects. The studies, tests and preclinical and clinical trials conducted by the Company or its subsidiaries and, to the knowledge of the Company, any studies, tests and preclinical and clinical trials conducted on behalf of the Company or in which the Company has participated, were, and if still pending are, being conducted in all material respects in accordance with all applicable rules and regulations of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such trials and studies contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trials and studies; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from any Regulatory Authority or any other governmental agency requiring or threatening the termination, material modification or suspension of any studies or trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and 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 in all material respects, and the Company 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 General Disclosure Package or the Prospectus; except as disclosed in the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; and, except as disclosed in to the Registration StatementCompany’s knowledge, there are no reasonable grounds for the General Disclosure Package and the Final Prospectus, 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 Governmental Entitiessame.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies conducted by or at the direction or on behalf of the Company (collectively, “studiesCompany Studies”) that are described in, or the results of which are referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) Company Studies and with standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description of the Company Studies that are described in, or the results of such studies is which are referred to in, the Registration Statement, the Pricing Disclosure Package or the Prospectus, is, in all material respects, accurate and complete fairly presents in all material respects and fairly presents the data derived from such studies in all material respects, Company Studies; each description of other preclinical tests and the Company clinical trials and its subsidiaries have no knowledge of any other studies conducted by third parties (collectively, the “Third-party Studies” that are described in, or the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus, accurately and fairly presents in all material respects the published results of such Third-party Studies; except as disclosed in to the Company’s knowledge, the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, as of the Applicable Time, did not, and as of the Closing Date and as of the Additional Closing Date, as the case may be, will not, omit to state a material fact relating to any preclinical tests and clinical trials, and other studies, necessary in order to make the statements relating to the Company Studies and Third-party Studies therein, in the light of the circumstances under which they were made, not misleading; the Company and its subsidiaries have made all such filings and obtained all such authorizations, clearances or approvals as may be have been required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof FDA or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any health care facility Institutional Review BoardBoard (collectively, the “Regulatory Agencies”), with respect to all clinical trials conducted by the Company, except where the failure to make such filings or obtain such authorizations, clearances or approvals would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity Regulatory Agency requiring the termination, suspension or modification, other than any modification in the ordinary course, of any clinical trials that are described or referred to in the Registration Statement, the General Pricing Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, 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 Governmental EntitiesRegulatory Agencies.

Clinical Data and Regulatory Compliance. The studies, tests and preclinical or clinical trials, and other studies (collectively, “studies”) trials conducted by or on behalf of the Company or its subsidiaries that are described in, or the results of which are referred to in the Registration Statement, the General Disclosure Package or Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being conducted in all material respects in accordance with (i) the experimental protocols, procedures and controls designed and approved for such studiesCompany Studies and Trials, pursuant to, where applicable, accepted professional scientific standards and all applicable statutes, rules and regulations of the jurisdictions in which such Company Studies and Trials were or are being conducted, including, but not limited to, requirements of the U.S. Food and Drug Administration (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulationsthe “FDA”); each description the descriptions of the results of such studies is the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly presents the data derived from such studies in all material respects, and ; the Company and its subsidiaries have has no knowledge of any other studies 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, in question the results described or referred to in the Registration StatementStatement and the Prospectus. The Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or ethics committee or similar body requiring or threatening the termination, suspension or material modification of any Company Studies or Trials and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who is participating or has participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the General Disclosure Package Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Prospectus; except Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. Except as disclosed in the Registration Statement, the General Disclosure Package Statement and the Final Prospectus, to the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the knowledge of the Company, the Company and its subsidiaries have made operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the regulatory authorities, except where such filings and obtained all such approvals as may non-compliance would not reasonably be required by any Governmental Entityexpected, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, individually or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statementaggregate, to result in a Material Adverse Change. The Company has provided the General Disclosure Package or Agent with all material written notices, correspondence and summaries of all other communications from the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package regulatory authorities. The manufacturing facilities and the Final Prospectus, operations of the Company and its subsidiaries have each and, to the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated and currently are in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Governmental Entitiesregulatory authorities.

Clinical Data and Regulatory Compliance. The clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description None of the results Company’s or any of such studies is accurate and complete in all material respects and fairly presents the data derived its subsidiaries’ product candidates have received marketing approval from such studies in all material respects, and the Company and its subsidiaries have no knowledge any 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 General Disclosure Package or the Prospectus; except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office or any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”). All clinical trials and preclinical studies conducted by or on behalf of Inspector General, Department of Justiceor sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, with respect to the Company’s or its subsidiaries’ product candidates, including any committee thereof such studies and trials that are described in the Registration Statement and the Prospectus, or from the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and, if still pending are, being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted. The descriptions in the Registration Statement and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom. The Company has no knowledge of any other U.S. studies or foreign government trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or drug call into question the results described or medical device regulatory agencyreferred to in the Registration Statement and the Prospectus. Except as described in the Registration Statement and the Prospectus, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received received, and neither the Company nor any of its subsidiaries has knowledge that any of their respective collaboration partners have received, any written notice ofnotices, correspondence or correspondence from, other communications from the Applicable Regulatory Authorities or any Governmental Entity other governmental entity requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or modification of any clinical trials that trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as described or referred to in the Registration Statement, the General Disclosure Package or Statement and the Prospectus; and, except as disclosed no investigational new drug application or comparable submission filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA or any other Applicable Regulatory Authority. In using or disclosing patient information received by the Company or any of its subsidiaries in the Registration Statement, the General Disclosure Package and the Final Prospectusconnection with a Company Trial, the Company or such subsidiary has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, and since July 1, 2016, the manufacturing facilities and operations of the Company’s and its subsidiaries have each subsidiaries’ suppliers are operated and currently are in compliance in all material respects with all applicable rulesstatutes, binding rules and regulations and policies of the Governmental EntitiesApplicable Regulatory Authorities.

Clinical Data and Regulatory Compliance. The clinical trials, trials and other studies (collectively, “studies”) conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in, or the results of which are referred to in in, the Registration Statement, the General Pricing Disclosure Package or and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) studies and with standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description of the results of such studies is accurate and complete is, in all material respects respects, accurate and fairly presents the data derived from such studies in all material respectsstudies, and the Company 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 General Pricing Disclosure Package or the Prospectus; except as disclosed in to the Registration Statement, knowledge of the General Disclosure Package and the Final ProspectusCompany, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be have been required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid ServicesU.S. Department of Agriculture, and the U.S. Department of Health and Human Services Office of Inspector GeneralServices, Department of Justicethe U.S. Environmental Protection Agency, or any committee thereof the U.S. Drug Enforcement Agency or from any other U.S. or foreign government or drug or medical device regulatory agencyagency (collectively, or by any Institutional Review Boardthe “Regulatory Agencies”); and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity Regulatory Agency requiring the termination, suspension or modification, other than any modification in the ordinary course, of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Pricing Disclosure Package and the Final ProspectusProspectus and, to the Company’s knowledge, 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 Governmental EntitiesRegulatory Agencies.

Clinical Data and Regulatory Compliance. The clinical trials, and other studies (collectively, “studies”) that are Except as described in, or the results of which are referred to in the Registration StatementStatement and the Prospectus, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description none of the results Company’s or any of such studies is accurate and complete in all material respects and fairly presents the data derived its subsidiaries’ product candidates have received marketing approval from such studies in all material respects, and the Company and its subsidiaries have no knowledge any 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 General Disclosure Package or the Prospectus; except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office or any comparable foreign or other regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”). All clinical trials and preclinical studies conducted by or on behalf of Inspector General, Department of Justiceor sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, with respect to the Company’s or its subsidiaries’ product candidates, including any committee thereof such studies and trials that are described in the Registration Statement and the Prospectus, or from the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and, if still pending are, being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) of the Applicable Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted. The descriptions in the Registration Statement and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom. The Company has no knowledge of any other U.S. studies or foreign government trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or drug call into question the results described or medical device regulatory agencyreferred to in the Registration Statement and the Prospectus. Except as described in the Registration Statement and the Prospectus, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received received, and neither the Company nor any of its subsidiaries has knowledge that any of their respective collaboration partners have received, any written notice ofnotices, correspondence or correspondence from, other communications from the Applicable Regulatory Authorities or any Governmental Entity other governmental entity requiring or threatening the termination, modification or suspension of Company Trials in any material respect, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or modification of any clinical trials that trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as described or referred to in the Registration Statement, the General Disclosure Package or Statement and the Prospectus; and, except as disclosed no investigational new drug application or comparable submission filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended in any material respect by the Registration Statement, FDA or any other Applicable Regulatory Authority. In using or disclosing patient information received by the General Disclosure Package and the Final ProspectusCompany or any of its subsidiaries in connection with a Company Trial, the Company or such subsidiary has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, and since April 1, 2020, the manufacturing facilities and operations of the Company’s and its subsidiaries have each subsidiaries’ suppliers are operated and currently are in compliance in all material respects with all applicable rulesstatutes, binding rules and regulations and policies of the Governmental EntitiesApplicable Regulatory Authorities.

Clinical Data and Regulatory Compliance. The preclinical studies and clinical trials, and other studies (collectively, “studies”) that are described intrials conducted by or on behalf of or sponsored by the Company or any of its subsidiaries, or in which the results Company’s or any of which are referred to in the Registration Statementits subsidiaries’ products or product candidates participated, the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in material compliance with all material respects in accordance with (i) applicable Health Care Laws and Permits; the protocols, procedures and controls designed and approved for such studies, (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulations; each description descriptions of the results of such research, studies is and tests contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly presents present the data derived from such studies in all material respectsresearch, studies, and tests; except to the extent disclosed in the Registration Statement and the Prospectus, the Company and its subsidiaries have no knowledge is not aware of any other preclinical studies or clinical trials, the results of which are materially inconsistent with, or otherwise the Company believes reasonably call into question, question the results described or referred to in the Registration Statement, the General Disclosure Package or Statement and the Prospectus; and, except as to the extent disclosed in the Registration Statement, the General Disclosure Package Statement and the Final Prospectus, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any Institutional Review Board; neither the Company nor any of its subsidiaries has received any written notice of, notices or correspondence from, from any Governmental Entity Authority requiring the termination, suspension or material modification of any preclinical study or clinical trials trial conducted by or on behalf of or sponsored by the Company or any of its subsidiaries. Any certificate signed by any officer or representative of the Company or any of its subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; Agent and, except as disclosed in for purposes of the Registration Statementopinions to be delivered pursuant to ‎Section 4(o) hereof, the General Disclosure Package and the Final Prospectus, counsel to the Company and its subsidiaries have each operated counsel to the Agent, will rely upon the accuracy and currently are in compliance in all material respects with all applicable rules, regulations and policies truthfulness of the Governmental Entitiesforegoing representations and hereby consents to such reliance.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies conducted by or at the direction or on behalf of the Company (collectively, “studiesCompany Studies”) that are described in, or the results of which are referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) Company Studies and with standard medical and scientific research procedures, and (iii) applicable laws and regulations; procedures; each description of the Company Studies that are described in, or the results of such studies is which are referred to in, the Registration Statement, the Pricing Disclosure Package or the Prospectus, is, in all material respects, accurate and complete fairly presents in all material respects and fairly presents the data derived from such studies in all material respects, Company Studies; each description of other preclinical tests and the Company clinical trials and its subsidiaries have no knowledge of any other studies conducted by third parties (collectively, the “Third-party Studies”) that are described in, or the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus, accurately and fairly presents in all material respects the published results of such Third-party Studies; except as disclosed in to the Company’s knowledge, the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, as of the Applicable Time, did not, and as of the Closing Date and as of the Additional Closing Date, as the case may be, will not, omit to state a material fact relating to any preclinical tests and clinical trials, and other studies, necessary in order to make the statements relating to the Company Studies and Third-party Studies therein, in the light of the circumstances under which they were made, not misleading; the Company and its subsidiaries have made all such filings and obtained all such authorizations, clearances or approvals as may be have been required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof FDA or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any health care facility Institutional Review Board; Board (collectively, the “Regulatory Agencies”), with respect to all clinical trials conducted by the Company, except where the failure to make such filings or obtain such authorizations, clearances or approvals would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity Regulatory Agency requiring the termination, suspension or modification, other than any modification in the ordinary course, of any clinical trials that are described or referred to in the Registration Statement, the General Pricing Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package Prospectus; and the Final Prospectus, 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 Governmental EntitiesRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies conducted by or at the direction or on behalf of the Company (collectively, “studiesCompany Studies”) that are described in, or the results of which are referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with (i) the protocols, procedures and controls designed and approved for such studies, (ii) Company Studies and with standard medical and scientific research procedures, and (iii) applicable laws and regulations; procedures; each description of the Company Studies that are described in, or the results of such studies is which are referred to in, the Registration Statement, the Pricing Disclosure Package or the Prospectus, is, in all material respects, accurate and complete fairly presents in all material respects and fairly presents the data derived from such studies in all material respects, Company Studies; each description of other preclinical tests and the Company clinical trials and its subsidiaries have no knowledge of any other studies conducted by third parties (collectively, the “Third-party Studies” that are described in, or the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in in, the Registration Statement, the General Pricing Disclosure Package or the Prospectus, accurately and fairly presents in all material respects the published results of such Third-party Studies; except as disclosed in to the Company’s knowledge, the Registration Statement, the General Pricing Disclosure Package and the Final Prospectus, as of the Applicable Time, did not, and as of the Closing Date and as of the Additional Closing Date, as the case may be, will not, omit to state a material fact relating to any preclinical tests and clinical trials, and other studies, necessary in order to make the statements relating to the Company Studies and Third-party Studies therein, in the light of the circumstances under which they were made, not misleading; the Company and its subsidiaries have made all such filings and obtained all such authorizations, clearances or approvals as may be have been required by any Governmental Entity, including the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare & Medicaid Services, and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof FDA or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any health care facility Institutional Review Board; Board (collectively, the “Regulatory Agencies”), with respect to all clinical trials conducted by the Company, except where the failure to make such filings or obtain such authorizations, clearances or approvals would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity Regulatory Agency requiring the termination, suspension or modification, other than any modification in the ordinary course, of any clinical trials that are described or referred to in the Registration Statement, the General Pricing Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package Prospectus; and the Final Prospectus, 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 Governmental EntitiesRegulatory Agencies.

Clinical Data and Regulatory Compliance. The studies, tests and preclinical or clinical trials, and other studies (collectively, “studies”) trials conducted by or on behalf of the Company that are described in, or the results of which are referred to in the Registration Statement, the General Disclosure Package or and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being being, conducted in all material respects in accordance with (i) the experimental protocols, procedures and controls designed pursuant to, where applicable, accepted professional scientific standards and approved for such studiesall applicable statutes, rules and regulations of the U.S. Food and Drug Administration (ii) standard medical and scientific research procedures, and (iii) applicable laws and regulationsthe “FDA”); each description the descriptions of the results of such studies is the Company Studies and Trials contained in the Registration Statement, the General Disclosure Package and Prospectus are accurate and complete in all material respects and fairly presents the data derived from such studies in all material respects, and ; the Company and its subsidiaries have has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are materially inconsistent with, with or otherwise call into question, in question the results described or referred to in the Registration Statement, the General Disclosure Package or and the Prospectus; except and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or ethics committee or similar body requiring or threatening the termination, suspension or material modification of any Company Studies or Trials and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who is participating or has participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. Except as disclosed in the Registration StatementStatement and Prospectus, to the General Disclosure Package Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the Final ProspectusFDA to have engaged in scientific misconduct. To the knowledge of the Company, the Company and its subsidiaries have made operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such filings non-compliance would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect. The Company has provided the Underwriters with all material written notices, correspondence and obtained summaries of all such approvals as may be required by any Governmental Entity, including other communications from the U.S. Food and Drug Administration (“FDA”)Regulatory Authorities. To the Company’s knowledge, the Centers for Medicare & Medicaid Services, manufacturing facilities and the Department of Health and Human Services Office of Inspector General, Department of Justice, or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or by any Institutional Review Board; neither the Company nor any operations of its subsidiaries has received any written notice of, or correspondence from, any Governmental Entity requiring the termination, suspension or modification of any clinical trials that suppliers are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; and, except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Governmental EntitiesRegulatory Authorities. Neither the Company nor its subsidiaries or any of their respective employees, officers, directors, or, except as disclosed in the Registration Statement and Prospectus, their respective agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company and its subsidiaries, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.