Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the protocolsFood 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, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresor health care facility Institutional Review Board; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, 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 Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, 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 agencyagencies, or foreign health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation Boards; and no investigational new drug application filed by or on behalf of the Company’s business as currently conducted, except as could not be expected, individually Company or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries with the FDA has received been terminated or suspended by the FDA, and neither the FDA nor any notice ofapplicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or correspondence fromotherwise terminate, delay or suspend, any Regulatory Agency requiring the termination, suspension proposed or modification ongoing studies conducted or proposed to be conducted by or on behalf of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and or any of its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by at the direction or on behalf of the Company, or in which the Company or its subsidiaries have participated (collectively, “studiesCompany Studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Company Studies and with standard medical and scientific research proceduresprocedures and all applicable statutes and all applicable rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); each description of the Company Studies that are described in, or the results of such studies is reasonably 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 in the context of the experimental set-up and fairly presents the data derived from such studies within the limits Company Studies; each description of interpretation by people trained in the trade, 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 inconsistent with, or otherwise call into question, the results described or referred to in in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus, accurately and fairly presents in all material respects the published results of such Third-Party Studies; to the knowledge of the Company, the Registration Statement, the Pricing Disclosure Package and the 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 described 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 the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof FDA 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”) for the operation of ), with respect to all clinical trials conducted by the Company’s business as currently conducted, except as could not be expectedwhere 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 have received any written notice of, or correspondence from, any 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 Time of Sale Prospectus Pricing Disclosure Package or the Prospectus, and, to the knowledge of the Company, 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 and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials being conducted or sponsored by the Company Company, and, to the knowledge of the Company, other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, areare being conducted, to the Company’s knowledge, being conducted in all material respects respects, in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete complete, in all material respects in the context of the experimental set-up respects, and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required for the conduct of the studies by the Israeli Ministry of Health, 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. U.S., Israeli or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance compliance, in all material respects respects, with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus SEC Documents were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical studies, tests and preclinical or clinical trials conducted by or sponsored by on behalf of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, areare being, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures and controls designed controls, including all applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description the descriptions of the results of such studies is reasonably the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and respects; 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 inconsistent with, with or otherwise call into question, in question the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus; and the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by has not received any written notices from or had any other correspondence with the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof foreign, state 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency local governmental body exercising comparable authority requiring the termination, suspension or material modification of any clinical trials that Company Studies or Trials for which termination, suspension or material modification would reasonably be expected to result in a Material Adverse Change and, to the Company’s knowledge, there are described no reasonable grounds for the same. In using or referred to disclosing patient information received by the Company, if any, in connection with the Registration StatementCompany Studies and Trials, the Time 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 Sale Prospectus or the Prospectus; 1996 and the rules and regulations thereunder (“HIPAA”). 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 or a comparable foreign regulatory authority to have engaged in scientific misconduct or violations of good clinical practices. To the Company’s knowledge, the manufacturing facilities and operations of its subsidiaries have each suppliers are operated and currently are in compliance in all material respects with all applicable rules statutes, rules, and regulations of the Regulatory Agencies, except as could not be expected, individually or in FDA and comparable regulatory agencies outside of the aggregate, United States to have a Material Adverse Effectwhich the Company is subject.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 applicable U.S. or foreign government or drug governmental agency engaged in the regulation of drugs or medical device regulatory agency, or health care facility Institutional Review Board devices (including diagnostics) (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to obtain such approval would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus, except those which have been removed or are no longer applicable or in effect or are disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company (collectively, “studiesStudies”) being conducted by or, to the knowledge of the Company for the Company or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pendingbeing conducted, are, to the Company’s knowledge, are being or were conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act, 21 U.S.C. (the “FDCA”) and the regulations promulgated thereunder, the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. federal, state or local, or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials Studies currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or sponsored by the Company that are described or disclosed in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the experimental protocols, procedures and controls designed and approved for such studies and with accepted standard medical and scientific research procedures; each description or disclosure of the results of such studies contained in the Registration Statement and the Prospectus is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, Statement and the Time Prospectus when viewed in the context in which such results are described and the state of Sale Prospectus or the Prospectusdevelopment; 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 agencyagency (including the Agence Nationale de Sécurité du Médicament et des Produits), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business to conduct their respective businesses as currently conducted, conducted and as described in the Registration Statement or the Prospectus; except as could not be expected, individually or disclosed in the aggregateRegistration Statement or the Prospectus, to have a Material Adverse Effect; 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 clinical trials that are described conducted by or referred on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the Registration Statement, the Time design and implementation of Sale Prospectus or the Prospectussuch trials; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and applicable study protocols approved for such studies and with standard medical applicable statutes and scientific research proceduresregulations promulgated by the U.S. Food and Drug Administration (“FDA”); each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or 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 Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical studies, tests and preclinical or clinical trials conducted by or sponsored by on behalf of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, in the Time of Sale Prospectus or and the Prospectus (the “Company Studies and Trials”) were and, if still pending, areare being, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures and controls designed controls, including all applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description the descriptions of the results of such studies is reasonably the Company Studies and Trials contained in the Time of Sale Prospectus and Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and respects; the Company and its subsidiaries have has no knowledge Knowledge of any other studies or trials not described in the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with, with or otherwise call into question, in question the results described or referred to in the Registration Statement, the Time of Sale Prospectus or and the Prospectus; and the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by has not received any written notices from or had any other correspondence with the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof foreign, state 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency local governmental body exercising comparable authority requiring the termination, suspension or material modification of any clinical trials that Company Studies or Trials for which termination, suspension or material modification would reasonably be expected to have a Material Adverse Change and, to the Company’s Knowledge, there are described no reasonable grounds for the same. In using or referred to disclosing patient information received by the Company, if any, in connection with the Registration StatementCompany Studies and Trials, the Time 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 Sale Prospectus or the Prospectus; 1996 and the rules and regulations thereunder. 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 or a comparable foreign regulatory authority to have engaged in scientific misconduct or violations of good clinical practices. To the Company’s Knowledge, the manufacturing facilities and operations of its subsidiaries have each suppliers are operated and currently are in compliance in all material respects with all applicable rules statutes, rules, and regulations of the Regulatory Agencies, except as could not be expected, individually or in FDA and comparable regulatory agencies outside of the aggregate, United States to have a Material Adverse Effectwhich the Company is subject.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable local, state, and scientific research proceduresfederal laws, rules, and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 (the “FDA”) 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”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted or sponsored being conducted by or on behalf of the Company or any subsidiary of the Company (collectively, “studiesCompany Studies”) and, to the Company’s knowledge, the preclinical tests and clinical trials, and other studies directed or sponsored by the Company’s collaborators (collectively, “Collaborator Studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Company Studies and Collaborator Studies and with standard medical and scientific research procedures; each description of the results of such studies Company Studies and, to the Company’s knowledge, such Collaborator Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeCompany Studies and Collaborator Studies, and the Company and its subsidiaries have no knowledge of any other studies Company Studies and Collaborator Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 European Medicines Agency, the Food and Drug Administration of the U.S. United States Department of Health and Human Services or any committee thereof or from any other U.S. United States or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, ); except as could not be expected, individually or described in the aggregateRegistration Statement, to have a Material Adverse Effect; the Time of Sale Prospectus or the Prospectus, 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusCompany Study and Collaborator Study; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory AgenciesAgencies (it being understood that the Company has no control over the design, except as could not be expectedprogress, individually timing, resources or in conduct of the aggregate, to have a Material Adverse EffectCollaborator Studies).

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company (collectively, “Company studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Company studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such Company studies within the limits of interpretation by people trained and, except as disclosed in the tradeRegistration Statement, the Time of Sale Prospectus and the Prospectus, the Company and its subsidiaries have no knowledge of any other Company studies or third-party studies the results of which are inconsistent in any material respect with, or otherwise call into questionquestion in any material respect, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Prospectuses and 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”) for in order to conduct the operation business of the Company’s business Company and its subsidiaries as currently presently conducted, except as could not be expected, individually or described in the aggregateRegistration Statement, to have a Material Adverse Effectthe Time of Sale Prospectus or the Prospectus; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The To the Company’s knowledge, (i) the preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; (ii) each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and studies; (iii) the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 (the “FDA”) 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”); (iv) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or described in the aggregateRegistration Statement, to have a Material Adverse Effect; the Time of Sale Prospectus or the Prospectus, 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, 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 Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could for such noncompliance that would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocolsapplicable Health Care Laws, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise materially call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedfor such failure which would not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse EffectChange; and neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material adverse modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expectedother than any suspension that was subsequently lifted prior to January 1, individually or in the aggregate, to have a Material Adverse Effect2018.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved protocols for such studies and in a manner consistent with standard medical and scientific research proceduresGood Clinical Practice; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge knowledge, as of the date hereof, of any other studies the results of which are inconsistent with, or otherwise call into question, conflict with the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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”) for ), in order to market the operation of Company’s products, to undertake clinical trials and otherwise conduct the Company’s business as currently conducteddisclosed in the Registration Statement, the Time of Sale Prospectuses or the Prospectus, except as where failure to make such filing or obtain such approval could not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable Health Care Laws, except where the protocolsfailure to be so conducted would not be expected, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresindividually or in the aggregate, to result in a Material Adverse Change; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the traderespects, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise materially call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the ProspectusProspectus when viewed in the context in which such results are described and the clinical state 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”) for except where the operation of the Company’s business as currently conducted, except as could failure to make such filings or obtain such approvals would not be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange; and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not Prospectus which would be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials being conducted or sponsored by the Company and its subsidiaries, and, to the knowledge of the Company, other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus SEC Documents were and, if still pending, areare being conducted, to the Company’s knowledge, being conducted in all material respects respects, in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete complete, in all material respects in the context of the experimental set-up respects, and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required for the conduct of the studies 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”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; and the Company and its subsidiaries have each operated and currently are in compliance compliance, in all material respects respects, with all applicable rules laws, rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws including, without limitation, the Federal Food, Drug, and Cosmetic Act and the implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals approvals, permits, licenses, exemptions, clearances or authorizations (“Regulatory 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such Regulatory Permit would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company or its subsidiaries (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents in all material respects the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise reasonably call into questionquestion in any material respect, the results described or referred to in the Registration 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 Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The Company and its subsidiaries have operated and currently are in compliance with all applicable rules, regulations and policies of the U.S. Food and Drug Administration and applicable foreign regulatory authorities (collectively, the “Regulatory Authorities”) in all material respects. The studies, tests and preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were its subsidiaries and, if still pending, are, to the knowledge of the Company’s knowledge, 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 protocols, procedures Regulatory Authorities and controls designed current Good Clinical Practices and approved for such studies and with standard medical and scientific research proceduresGood Laboratory Practices; each description the descriptions of the results of such trials and studies is reasonably contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained in the trade, trials and studies; the Company and its subsidiaries have 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, with or otherwise call into question, question the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Pricing Disclosure Package and 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has have received any notice ofwritten notices, correspondence or correspondence from, other communications from any Regulatory Agency Authority or any other governmental agency requiring or threatening the termination, material modification or suspension or modification of any clinical studies or trials 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 Time of Sale Prospectus or Pricing Disclosure Package and the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregateand, to have a Material Adverse Effectthe Company’s knowledge, there are no reasonable grounds for the same.

Clinical Data and Regulatory Compliance. The The-preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or, to the knowledge of the Company after due inquiry, 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, the Registration Statement, the Time of Sale Prospectus or Information and the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete is, in all material respects in the context of the experimental set-up respects, accurate and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Information and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be have been 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedwhere the failure to make such filings or obtain such 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 Regulatory Agency requiring or threatening 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 Time of Sale Information and the Prospectus or and, to the ProspectusCompany’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 rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for except where the operation of the Company’s business as currently conducted, except as failure to make such filing or obtain such approval could not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable local, state and scientific research proceduresfederal laws, rules and regulations, including the Federal Food, Drug, and Cosmetic Act; each description in the Registration Statement, the Time of Sale Prospectus and the Prospectus of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeall material respects, and to the Company and its subsidiaries have Company’s knowledge, there are no knowledge of any other studies the results of which are materially inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses, or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals Permits as may be required to be made or obtained by the Company by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from by any other applicable U.S. or foreign government or governmental drug or medical device regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make any such filing or obtain any such Permit would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect; neither other than as described in the Registration Statement, the Time of Sale Prospectus or the Prospectus, the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 applicable U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board governmental agency (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to obtain such approval would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and tests, clinical trials conducted or sponsored by the Company and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectEvent; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or, to the knowledge of the Company after due inquiry, 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, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete is, in all material respects in the context of the experimental set-up respects, accurate and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale 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 have been 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedwhere the failure to make such filings or obtain such 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 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 Time of Sale Prospectus Pricing Disclosure Package or the 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 rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls applicable study protocols designed and approved for such studies and with standard medical applicable statutes and scientific research proceduresregulations promulgated by the U.S. Food and Drug Administration (“FDA”); each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or 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 Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s their business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company (collectively, “studiesStudies”) that are described in, or the results of which are described or referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not limited to those for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and the amendments thereto (the “Applicable Laws”). The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the U.S. Food and Drug Administration of the U.S. Department of Health (“FDA”) and Human Services or any committee thereof or from any other U.S. federal, state, local or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the products being developed by the Company and its subsidiaries (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules Applicable laws, rules, and regulations of the Regulatory Agencies. The Company and its subsidiaries, except as could are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not be expectedlimited to those for the ownership, individually testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the amendments thereto and the regulations promulgated thereunder, in all material respects. Neither the aggregateCompany nor its subsidiaries have received any written notice of adverse finding, warning letter or other written correspondence or notice from the FDA or any other governmental entity alleging or asserting noncompliance with any Applicable Laws; the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company or its subsidiaries that could reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity; neither the Company nor its subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits or has any knowledge that any such governmental entity has threatened or is considering such action; and the Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a Material Adverse Effectsubsequent submission), in all material respects. Neither the Company, its subsidiaries and, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity.

Clinical Data and Regulatory Compliance. The Company and its subsidiaries have each operated in, and currently are, in compliance in all material respects with all applicable rules and regulations of any Drug Regulatory Agency or other federal, state or local governmental entity, or any Institutional Review Board (collectively, the “Regulatory Agencies” and each individually a “Regulatory Agency”) having jurisdiction over drugs or biological products as those terms are defined by the FDCA and the PHSA. Without limiting the generality of the foregoing, the preclinical tests and clinical trials trials, and any other studies being conducted or sponsored by the Company and its subsidiaries with respect to any pharmaceutical or biopharmaceutical product (collectively, “studiesStudies” and each individually a “Study”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the applicable protocols, procedures laws and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the traderegulations, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, 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 any Regulatory Agency for the Food and Drug Administration conduct 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 agencyStudies described in, or health care facility Institutional Review Board (collectivelythe results of which are referred to in, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither 2023 SEC Reports. Neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the terminationtermination or suspension, suspension or modification any adverse modification, of any clinical trials that are described or referred to in the Registration Statement2023 SEC Reports and, to the Time knowledge of Sale Prospectus the Company and its subsidiaries, no such action by a Regulatory Agency is being considered. All reports of results from any Study that is described or referred to in the Prospectus; 2023 SEC Reports are accurate and complete in all material respects and fairly present the data derived from the relevant Study, and the Company and its subsidiaries have each operated and currently no knowledge of any other Studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in compliance in all material respects with all applicable rules and regulations the 2023 SEC Reports. To the knowledge of the Regulatory AgenciesCompany, except as could not be expectedno event has occurred that has materially and adversely affected the integrity, individually or in the aggregate, of data or other results collected or otherwise obtained in connection with clinical trials, nonclinical research or manufacturing activities conducted by or on behalf of the Company, on the overall conclusions in any such trial or research with respect to have the Company’s product candidates. Additionally, neither the Company nor, to the Company's knowledge, any officer, employee, or agent of the Company, has (a) failed to disclose a material fact required to be disclosed to any Regulatory Agency, (b) made an untrue statement of a material fact or fraudulent statement to any Regulatory Agency, or (c) has committed any act, made any statement or failed to make any statement that would provide a basis for the FDA or any other Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Adverse EffectFacts, Bribery, and Illegal Gratuities,” or other similar policies or Laws.

Clinical Data and Regulatory Compliance. The preclinical tests and tests, clinical trials conducted or sponsored by the Company and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Disclosure Package or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from by 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”) for the operation of the Company’s business as currently conducted, except as could where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring which would reasonably be expected to lead to the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Disclosure Package or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted or sponsored by that are described in the Company Registration Statement and Prospectus (collectively, “studiesStudies”) that are described inwere conducted by or, to the knowledge of the Company, on behalf of the Company or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus its subsidiaries were and, if still pendingongoing, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and pursuant to, where applicable, accepted professional scientific research proceduresstandards; each description the descriptions of the results of such studies is reasonably contained in the Registration Statement and Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained Studies, in the tradeeach case in all material respects, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Statement and Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has have received any notice offrom, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described Studies conducted by or referred to on behalf of the Company or its subsidiaries, except as disclosed in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus 2023 SEC Reports were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; (ii) each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2023 SEC Reports; (iii) the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof FDA or from any other U.S. federal, state or local government or foreign government or drug or medical device regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducted, except as could not be expected, individually or described in the aggregate, to have a Material Adverse Effect2023 SEC Reports; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2023 SEC Reports; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) conducted by the Company 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 Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical studies, which represent, to the extent applicable, accepted professional and scientific research proceduresstandards for products or product candidates comparable to those being developed by the Company and its subsidiaries; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies with respect to the Company's product candidates not described in the Registration Statement, the Time of Sale Prospectuses or the Prospectus the results of which are inconsistent with, or otherwise reasonably call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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”) for in connection with the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectstudies; 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 clinical trials of the Company or on behalf of the Company that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Prospectus Information Documents were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies, as amended from time to time; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents in all material respects the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies studies, other than as may be addressed in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Information Documents, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the ProspectusInformation Documents when viewed in the context in which such results are described and the state 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 agencyagency (including the Agence Nationale de Sécurité du Médicament et des Produits de Santé (“ANSM”)), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business to conduct their respective businesses as currently conductedconducted and as described in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Information Documents; except as could not be expected, individually or disclosed in the aggregateRegistration Statement, to have a Material Adverse Effect; the Time of Sale Prospectus, the Prospectus or the Information Documents, 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 before proceeding of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the ProspectusInformation Documents; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and any clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, 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 Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could for such noncompliance that would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Information or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Information 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 applicable U.S. or foreign government or drug governmental agency engaged in the regulation of drugs or medical device regulatory agency, or health care facility Institutional Review Board devices (including diagnostics) (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to obtain such approval would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Information or the Prospectus, except those which have been removed or are no longer applicable or in effect or are disclosed in the Registration Statement, the Time of Sale Information and the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, ); except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect, for the conduct of its business as described in the Registration Statement, the Time of Sale Prospectuses and the Prospectus; 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 clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, the “studiesStudies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have has no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the . The Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by the Food and Drug Administration (the “FDA”) of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither . Except such as are described in the Registration Statement and the Prospectus, the Company nor any of its subsidiaries has not received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical studies and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and clinical trials and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, applicable regulations and other requirements of the United States Food and Drug Administration (the “FDA”), the European Medicines Agency (“EMA”), and other U.S. or foreign government or drug or medical device regulatory agencies, or any committee thereof, or health care facility Institutional Review Board having jurisdiction over the nonclinical studies, clinical trials and marketing applications that the Company or its Subsidiaries intend to submit (collectively with the FDA and EMA, the “Regulatory Agencies”); each description of the results of such studies and clinical trials is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeand clinical trials, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies or clinical trials the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) Agencies for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any of the Regulatory Agency Agencies requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules regulations and regulations other requirements of each of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or, to the knowledge of the Company after due inquiry, 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, the Registration Statement, the Time of Sale Prospectus or Information and the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete is, in all material respects in the context of the experimental set-up respects, accurate and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Information and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be have been 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedwhere the failure to make such filings or obtain such 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 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 Time of Sale Information and the Prospectus or and, to the ProspectusCompany’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 rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The research, preclinical tests and clinical trials, and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical trials conducted directed or sponsored by the Company Company’s collaborators (collectively, “studiesStudies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) except for the operation of the Company’s business as currently conducted, except as could not be expectedsuch failures that, individually or in the aggregate, would not reasonably be expected to have result in a Material Adverse EffectChange; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, except as could not be expected, individually or the manufacturing facilities and operations of its suppliers are operated in the aggregate, to have a Material Adverse Effectcompliance in all material respects with all applicable laws and governmental permits.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company trials, (collectively, “studiesStudies”) that are described in, or the results of which are described or referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not limited to those for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and the amendments thereto (the “Applicable Laws”). The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the U.S. Food and Drug Administration of the U.S. Department of Health (“FDA”) and Human Services or any committee thereof or from any other U.S. federal, state, local or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the products being developed by the Company and its subsidiaries (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules Applicable laws, rules, and regulations of the Regulatory Agencies. The Company and its subsidiaries, except as could are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not be expectedlimited to those for the ownership, individually testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the amendments thereto and the regulations promulgated thereunder, in all material respects. Neither the aggregateCompany nor its subsidiaries have received any written notice of adverse finding, warning letter or other written correspondence or notice from the FDA or any other governmental entity alleging or asserting noncompliance with any Applicable Laws; the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company or its subsidiaries that could reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity; neither the Company nor its subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits or has any knowledge that any such governmental entity has threatened or is considering such action; and the Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a Material Adverse Effectsubsequent submission), in all material respects. Neither the Company, its subsidiaries and, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company (collectively, “studiesStudies”) that are described in, or the results of which are described or referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not limited to those for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and the amendments thereto (the “Applicable Laws”). The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the U.S. Food and Drug Administration of the U.S. Department of Health (“FDA”) and Human Services or any committee thereof or from any other U.S. federal, state, local or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the products being developed by the Company and its subsidiaries (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules laws, rules, and regulations of the Regulatory Agencies. The Company and its subsidiaries, except as could are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its subsidiaries including, but not be expectedlimited to those for the ownership, individually testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the amendments thereto and the regulations promulgated thereunder, in all material respects. Neither the aggregateCompany nor its subsidiaries have received any written notice of adverse finding, warning letter or other written correspondence or notice from the FDA or any other governmental entity alleging or asserting noncompliance with any Applicable Laws; the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company or its subsidiaries that could reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity; neither the Company nor its subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits or has any knowledge that any such governmental entity has threatened or is considering such action; and the Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a Material Adverse Effectsubsequent submission), in all material respects. Neither the Company, its subsidiaries and, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity.

Clinical Data and Regulatory Compliance. The preclinical tests Except as described in the Registration Statement and the Prospectus, none of the Company’s or any of its subsidiaries’ product candidates have received marketing approval from any of the U.S. Food and Drug Administration (“FDA”), the U.S. Department of Health and Human Services 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 or sponsored by the Company (collectivelyor its subsidiaries, “studies”) or in which the Company or its subsidiaries have participated, with respect to the Company’s or its subsidiaries’ product candidates, including any such studies and trials that are described inin the Registration Statement and the Prospectus, or the results of which are referred to in, in the Registration StatementStatement and the Prospectus, the Time of Sale Prospectus or the Prospectus were as applicable (collectively, “Company Trials”), were, and, if still pending, pending are, to the Company’s knowledge, being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) of the protocols, procedures Applicable Regulatory Authorities and controls designed current Good Clinical Practices and approved for 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 with standard medical and scientific research procedures; each description the Prospectus of the results of such studies is reasonably any Company Trials are accurate and complete descriptions in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained in the trade, and the therefrom. 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 inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals . Except 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or described in the aggregateRegistration Statement and the Prospectus, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received received, and neither the Company nor any notice of, or correspondence fromof its subsidiaries has knowledge that any of their respective collaboration partners have received, any written notices, correspondence or other communications from the Applicable Regulatory Agency Authorities or any 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 StatementStatement and the Prospectus, 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 FDA or any other Applicable Regulatory Authority. In using or disclosing patient information received by the Company or any of its subsidiaries in connection with a Company Trial, the Time 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 Sale Prospectus or 1996, as amended by the Prospectus; 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 statutes, binding rules and regulations of the Applicable Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse EffectAuthorities.

Clinical Data and Regulatory Compliance. The Except as otherwise disclosed in the Registration Statement or the Prospectus, and except as would not, individually or in the aggregate, result in a Material Adverse Change, the studies, tests and preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, areor, to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of or sponsored by the Company or in which the Company has participated, were, and if still pending are being conducted in all material respects in accordance with the standard medical and experimental protocols, procedures and controls designed and approved for such studies and with standard medical and pursuant to accepted professional scientific research standards and procedures, and all applicable Health Care Laws, the rules and regulations of the Regulatory Authorities and, to the extent required, current Good Clinical Practices and Good Laboratory Practices; each description (ii) the descriptions of the results of such studies is reasonably and trials contained in the Registration Statement or the Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained in the trade, trials and studies; (iii) the Company and its subsidiaries have has no knowledge of any other studies or trials not described in the Registration Statement or the Prospectus, the results of which are materially inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration StatementStatement or the Prospectus, and has provided Wedbush with all substantive written notices, correspondence and summaries of all other communications provided to the Time Company from the Regulatory Authorities; and (iv) the Company has not received any written notices or correspondence from any Regulatory Authority or any other governmental entity requiring the termination, material modification or suspension of Sale any studies or trials that are described in the Registration Statement or the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus; . Except as otherwise disclosed in the Company Registration Statement or the Prospectus, 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”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, to have result in a Material Adverse EffectChange, (i) the Company has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and, all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were timely, complete, accurate and not misleading in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); (ii) the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or Regulatory Authority, other governmental entity or third party alleging that any Company or product operation or activity is in violation of any Health Care Laws, including, without limitation, any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other Regulatory Authority or governmental entity, nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (iii) the Company is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Regulatory Authority or other governmental entity; and (iv) neither the Company nor its employees, officers or directors 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 its subsidiaries has received any notice ofthe Company, is subject to an inquiry, investigation, proceeding or other similar action by a Regulatory Authority or other governmental entity that could reasonably be expected to result in debarment, suspension, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any exclusion. The Company’s clinical trials that laboratory tests are described or referred to conducted in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in material compliance in all material respects with all applicable rules and regulations of the Regulatory AgenciesHealth Care Laws, except as could not be expected, individually or in the aggregateand, to have a Material Adverse Effectthe extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. The Company has not received written notice from any Regulatory Authority alleging or asserting noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company trials, (collectively, “studiesStudies”) that are described in, or the results of which are described or referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries Subsidiaries are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its Subsidiaries including, but not limited to those for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and the amendments thereto (the “Applicable Laws”). The Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the U.S. Food and Drug Administration of the U.S. Department of Health (“FDA”) and Human Services or any committee thereof or from any other U.S. federal, state, local or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the products being developed by the Company and its Subsidiaries (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules Applicable laws, rules, and regulations of the Regulatory Agencies. The Company and its Subsidiaries, except as could are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its Subsidiaries including, but not be expectedlimited to those for the ownership, individually testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the amendments thereto and the regulations promulgated thereunder, in all material respects. Neither the aggregateCompany nor its Subsidiaries have received any written notice of adverse finding, warning letter or other written correspondence or notice from the FDA or any other governmental entity alleging or asserting noncompliance with any Applicable Laws; the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company or its Subsidiaries that could reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity; neither the Company nor its Subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits or has any knowledge that any such governmental entity has threatened or is considering such action; and the Company and its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a Material Adverse Effectsubsequent submission), in all material respects. Neither the Company, its Subsidiaries and, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted that are described in the Registration Statement or sponsored by the Company Prospectus (collectively, “studiesStudies”) that are described inwere conducted by or, to the knowledge of the Company, on behalf of the Company or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus its subsidiaries were and, if still pendingongoing, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and pursuant to, where applicable, accepted professional scientific research proceduresstandards; each description the descriptions of the results of such studies is reasonably contained in the Registration Statement or the Prospectus are accurate and complete descriptions in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained Studies, in the tradeeach case in all material respects, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 FDA 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”) for the operation of the Company’s business as currently conducted), except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has have received any notice offrom, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described Studies conducted by or referred to in on behalf of the Registration Statement, the Time of Sale Prospectus Company or the Prospectusits subsidiaries; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus Supplement were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusProspectus Supplement; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusProspectus Supplement; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, 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 Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus General Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls applicable study protocols designed and approved for such studies and with standard medical applicable statutes and scientific research proceduresregulations promulgated by the U.S. Food and Drug Administration (“FDA”); each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, one would reasonably believe to materially contradict the results described or referred to in the Registration Statement, the Time of Sale 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 FDA 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 Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s their business as currently conducteddescribed in the Registration Statement, General Disclosure Package and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus 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 rules, regulations and regulations policies of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or Document and the Prospectus Final Offering Memorandum were and, if still pending, are, to the Company’s knowledge, are being conducted (x) in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act (“FFDCA”) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, and (y) except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, with the protocols, procedures and controls designed and approved for such studies and 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 Company; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Document and the ProspectusFinal Offering Memorandum; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus or Document and the ProspectusFinal Offering Memorandum and, to the Company’s knowledge, there are no reasonable grounds for the same; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. Except as disclosed in the Time of Sale Document and the Final Offering Memorandum, except as could the Company has not be expectedmade any knowingly false statements on, individually 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 aggregaterequirements 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 have a Material Adverse Effectthe knowledge of the Company, any officer, key employee or agent of the Company has been convicted 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 research, preclinical tests and clinical trials, and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical trials conducted directed or sponsored by the Company Company’s collaborators (collectively, “studiesStudies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) except for the operation of the Company’s business as currently conducted, except as could not be expectedsuch failures that, individually or in the aggregate, would not reasonably be expected to have result in a Material Adverse EffectChange; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, except as could not be expected, individually or the manufacturing facilities and operations of its suppliers are operated in the aggregate, to have a Material Adverse Effect.compliance in all material respects with all applicable laws and governmental permits

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies studies, as amended, and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such material filings and obtained all such 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and and, with respect to such studies, the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The research, preclinical tests and clinical trials, and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical trials conducted directed or sponsored by the Company Company’s collaborators (collectively, “studiesStudies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale 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”) except for the operation of the Company’s business as currently conducted, except as could not be expectedsuch failures that, individually or in the aggregate, would not reasonably be expected to have result in a Material Adverse EffectChange; 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, except as could not be expected, individually or the manufacturing facilities and operations of its suppliers are operated in the aggregate, to have a Material Adverse Effectcompliance in all material respects with all applicable laws and governmental permits.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company and its subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus 2022 SEC Reports were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the 2022 SEC Reports. The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the 2022 SEC Reports, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither . Neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement2022 SEC Reports, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The Except as described in the Registration Statement and the Prospectus, as applicable, the tests, preclinical tests studies and clinical trials conducted that are described in the Registration Statement or sponsored by the Company Prospectus (collectively, “studiesStudies”) that are described inconducted by or, to the knowledge of the Company, on behalf of the Company or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus its subsidiaries were and, if still pendingongoing, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and and, if applicable, approved for such studies Studies and with standard medical pursuant to all applicable laws and any applicable rules and regulations of the jurisdictions in which such Studies are being conducted, and where applicable, accepted professional scientific research proceduresstandards; each description the descriptions of the results of such studies is reasonably Studies contained in the Registration Statement or the Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained Studies, in the tradeeach case in all material respects, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made operated at all such filings times and obtained are currently in compliance in all such approvals as may be required by material respects with all applicable statutes, rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside 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 United States to which they are subject (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be expectedwhere such non-compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has subsidiaries, to the Company’s knowledge, have received any notice ofor correspondence from the Regulatory Agencies, institutional review board, ethics committee, or correspondence fromsimilar body, or any Regulatory Agency other governmental agency requiring or threatening the termination, suspension or material modification of any clinical trials that are described or referred Studies, other than ordinary course communications with respect to modifications in connection with the Registration Statement, the Time design and implementation of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsuch Studies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, ); except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect, for the conduct of its business as described in the Registration Statement, the Pricing Prospectuses and the Prospectus; 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 clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in 218136659 v11 compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries subsidiary have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries subsidiary have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries subsidiary has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries subsidiary have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the all applicable protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other Company studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; . Except where such failure that could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither ). 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 clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the . The Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed and approved for such studies and with standard medical and scientific research proceduresapplicable laws; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the Company would reasonably expect to contradict the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its current business as currently conducteddescribed in the Registration Statement and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations laws of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, 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 Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. Any certificate signed by any officer of the Company or any of its subsidiaries and delivered to any Underwriter or to counsel for the Underwriters in connection with the offering, except or the purchase and sale, of the Offered Shares shall be deemed a representation and warranty by the Company to each Underwriter as could not to the matters covered thereby. The Company acknowledges that the Underwriters and, for purposes of the opinions to be expecteddelivered pursuant to ‎Section 6 hereof, individually or in counsel to the aggregateCompany and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to have a Material Adverse Effectsuch reliance.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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 U.S. or foreign government or drug or medical device regulatory agencyagency (including any U.S. state departments of health and boards of pharmacy), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect; 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 clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company and other studies (collectively, “studiesStudies”) conducted by or on behalf of the Company or its subsidiaries, or in which the Company’s product candidates have participated, including those that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects with applicable laws, including, without limitation, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the rules and regulations promulgated thereunder and any applicable statutes, rules, regulations and policies of the jurisdictions in accordance with the protocols, procedures and controls designed and approved for which such studies and with standard medical and scientific research proceduresStudies are being conducted; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals or authorizations as may be required by the Food and Drug Administration (the “FDA”) of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effectmaterial adverse effect on the Company and its subsidiaries, taken as a whole; and except as described in the Registration Statement and the Prospectus, neither the Company nor any of its subsidiaries has have received any notice of, or correspondence from, any Regulatory Agency or health care facility Institutional Review Board requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and , nor is the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations aware of the Regulatory Agencies, except as could not be expected, individually any reasonable grounds for such notice or in the aggregate, to have a Material Adverse Effectcorrespondence.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and studies, with standard medical and scientific research proceduresprocedures and where applicable, with accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus 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 state, U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the 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 rules, regulations and regulations policies of the Regulatory Agencies. Except as disclosed in the Registration Statement, except as could the Time of Sale Prospectus or the Prospectus, the Company has not be expectedmade any knowingly false statements on, individually 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 aggregaterequirements of any Regulatory Agencies relating to the Company’s approved product, tentatively approved product, or product candidates. Except as disclosed in the Registration Statement, the Time of Sale Prospectus or the Prospectus, neither the Company nor, to have a Material Adverse Effectthe knowledge of the Company, any officer, key employee or agent of the Company has been convicted 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 or (b) exclusion under 42 USC Section 1320a-7 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 conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus, the Prospectus or the French Listing Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies, as amended from time to time; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents in all material respects the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies studies, other than as may be addressed in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the French Listing Prospectus, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the ProspectusFrench Listing Prospectus when viewed in the context in which such results are described and the state 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 agencyagency (including the Agence Nationale de Sécurité du Médicament et des Produits (“ANSM”)), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business to conduct their respective businesses as currently conductedconducted and as described in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the French Listing Prospectus; except as could not be expected, individually or disclosed in the aggregateRegistration Statement, to have a Material Adverse Effect; the Time of Sale Prospectus, the Prospectus or the French Listing Prospectus, 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 before proceeding of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the French Listing Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The Company and its subsidiaries have each operated in, and currently are, in compliance in all material respects with all applicable rules and regulations of any Drug Regulatory Agency or other federal, state or local governmental entity, or any Institutional Review Board (collectively, the “Regulatory Agencies” and each individually a “Regulatory Agency”) having jurisdiction over drugs or biological products as those terms are defined by the FDCA and the PHSA. Without limiting the generality of the foregoing, the preclinical tests and clinical trials trials, and any other studies being conducted or sponsored by the Company and its subsidiaries with respect to any pharmaceutical or biopharmaceutical product (collectively, “studiesStudies” and each individually a “Study”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the applicable protocols, procedures laws and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the traderegulations, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, 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 any Regulatory Agency for the Food and Drug Administration conduct 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 agencyStudies described in, or health care facility Institutional Review Board (collectivelythe results of which are referred to in, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither 2022 SEC Reports. Neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement2022 SEC Reports and, to the Time knowledge of Sale Prospectus the Company and its subsidiaries, no such action by a Regulatory Agency is being considered. All reports of results from any Study that is described or referred to in the Prospectus; 2022 SEC Reports are accurate and complete in all material respects and fairly present the data derived from the relevant Study, and the Company and its subsidiaries have each operated and currently no knowledge of any other Studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in compliance in all material respects with all applicable rules and regulations the 2022 SEC Reports. To the knowledge of the Regulatory AgenciesCompany, except as could not be expectedno event has occurred that has materially and adversely affected the integrity, individually or in the aggregate, of data or other results collected or otherwise obtained in connection with clinical trials, nonclinical research or manufacturing activities conducted by or on behalf of the Company, on the overall conclusions in any such trial or research with respect to have the Company’s product candidates. Additionally, neither the Company nor, to the Company’s knowledge, any officer, employee, or agent of the Company, has (a) failed to disclose a material fact required to be disclosed to any Regulatory Agency, (b) made an untrue statement of a material fact or fraudulent statement to any Regulatory Agency, or (c) has committed any act, made any statement or failed to make any statement that would provide a basis for the FDA or any other Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Adverse EffectFacts, Bribery, and Illegal Gratuities,” or other similar policies or Laws.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, 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 Time of Sale Prospectus 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”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); 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 clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could for such noncompliance that would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or sponsored by the Company that are described or disclosed in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the experimental protocols, procedures and controls designed and approved for such studies and with accepted standard medical and scientific research procedures; each description or disclosure of the results of such studies contained in the Registration Statement or the Prospectus is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the ProspectusProspectus when viewed in the context in which such results are described and the state 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 agencyagency (including the Agence Nationale de Sécurité du Médicament et des Produits), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business to conduct their respective businesses as currently conducted, conducted and as described in the Registration Statement or the Prospectus; except as could not be expected, individually or disclosed in the aggregateRegistration Statement or the Prospectus, to have a Material Adverse Effect; 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 clinical trials that are described conducted by or referred on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the Registration Statement, the Time design and implementation of Sale Prospectus or the Prospectussuch trials; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.