Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls, including all applicable laws and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company 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 or call in question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notices from or had any other correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any 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 no reasonable grounds for the same. In using or disclosing patient information received by the Company, if any, in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder (“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 suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Clinical Data and Regulatory Compliance. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement Time of Sale Prospectus and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls, including all applicable laws and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement Time of Sale Prospectus and Prospectus are accurate in all material respects; the Company has no knowledge Knowledge of any other studies or trials not described in the Registration Statement Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement Time of Sale Prospectus and the Prospectus; and the Company has not received any written notices from or had any other correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials for which termination, suspension or material modification would reasonably be expected to result in have a Material Adverse Change and, to the Company’s knowledgeKnowledge, there are no reasonable grounds for the same. In using or disclosing patient information received by the Company, if any, in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder (“HIPAA”)thereunder. To the Company’s knowledgeKnowledge, 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 knowledgeKnowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Clinical Data and Regulatory Compliance. The Any studies, tests and preclinical and clinical trials conducted by the Company and, to the knowledge of the Company, any studies, tests and preclinical and clinical trials conducted on behalf of the Company or in which the Company has participated, were, and if still pending are, being conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable rules and regulations, including those of the #95429626v5 #95429626v9 FDA and comparable regulatory agencies outside of the United States, to which the Company is subject and, for studies submitted to regulatory authorities as a basis for regulatory approval and preclinical and clinical trials, current Good Clinical Practices and Good Laboratory Practices, except where the failure to be so conducted would not reasonably be expected to have a Material Adverse Effect; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the Disclosure Package or the Prospectus, the Company has not received any notices or correspondence from the FDA or any other comparable federal, state, local or foreign governmental or regulatory authority requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls, including all applicable laws and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company 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 or call in question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notices from or had any other correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any 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 no reasonable grounds for the same. In using or disclosing patient information received by the Company, if any, in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder (“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 suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Clinical Data and Regulatory Compliance. The studies, preclinical tests and preclinical or clinical trials conducted by or on behalf of the Company and other studies (collectively, “studies”) that are described in in, or the results of which are referred to in, the Registration Statement and Statement, the Time of Sale Prospectus or the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, being conducted in all material respects in accordance with experimental the protocols, procedures and controlscontrols designed and approved for such studies and all applicable local, state and federal laws, rules and regulations, including all applicable laws the Federal Food, Drug, and regulationsCosmetic Act; each description in the descriptions Registration Statement, the Time of Sale Prospectus and the Prospectus of the results of such studies is accurate and complete in all material respects and fairly presents the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate data derived from such studies in all material respects; , and to the Company has Company’s knowledge, there are no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are materially inconsistent with or otherwise call in into question the results described or referred to in the Registration Statement and Statement, the Time of Sale Prospectuses, or the Prospectus; the Company has made all such filings and obtained all such 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 by any other applicable U.S. or foreign governmental drug or medical device regulatory agency (collectively, the “Regulatory Agencies”), except 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; other than as described in the Registration Statement, the Time of Sale Prospectus or the Prospectus, the Company has not received any written notices from notice of, or had correspondence from, any other correspondence with Regulatory Agency requiring, and, to the FDA or any foreignknowledge of the Company, state or local governmental body exercising comparable authority requiring no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any Company Studies clinical trials that are described or Trials for which termination, suspension or material modification would reasonably be expected referred to result in a Material Adverse Change and, to the Company’s knowledge, there are no reasonable grounds for the same. In using or disclosing patient information received by the Company, if any, in connection with the Company Studies and TrialsRegistration Statement, the Company has complied in all material respects with all applicable laws and regulatory rules Time of Sale Prospectus or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 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 suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subjectProspectus.

Clinical Data and Regulatory Compliance. The studies, preclinical tests and preclinical or clinical trials trials, and other studies (collectively, “studies”) conducted by or 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 in, or the results of which are referred to in, the Registration Statement Statement, the Time of Sale Information and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, being conducted in all material respects in accordance with experimental the protocols, procedures and controls, including all applicable laws controls designed and regulationsapproved for such studies and with standard medical and scientific research procedures; the descriptions each description of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate such studies is, in all material respects; , accurate and fairly presents the data derived from such studies, and the Company has and its subsidiaries have 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 in question into question, the results described or referred to in the Registration Statement Statement, the Time of Sale Information and the Prospectus; and the Company and its subsidiaries have made all such filings and obtained all such approvals as have been required by the Food and Drug Administration of the U.S. Department of Health and Human Services or from any other U.S. or foreign government medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”), except where 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 its subsidiaries has not received any written notices from notice of, or had correspondence from, any other correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority Regulatory Agency requiring the termination, suspension or material modification, other than any modification in the ordinary course, of any Company Studies clinical trials that are described or Trials for which terminationreferred to in the Registration Statement, suspension or material modification would reasonably be expected to result in a Material Adverse Change the Time of Sale Information and the Prospectus and, to the Company’s knowledge, there are no reasonable grounds for the same. In using or disclosing patient information received by the Company, if any, in connection with ; and the Company Studies and Trials, the Company has complied in all material respects with all applicable laws its subsidiaries have each operated and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 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 suppliers currently are operated in compliance in all material respects with all applicable statutes, rules, regulations and regulations policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subjectRegulatory Agencies.

Clinical Data and Regulatory Compliance. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement Statement, the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controlscontrols pursuant to, including where applicable, accepted professional scientific standards and all applicable laws statutes, rules and regulationsregulations of the U.S. Food and Drug Administration (the “FDA”); the descriptions of the results of the Company Studies and Trials contained in the Registration Statement Statement, the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement Statement, the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence from or had any other correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or ethics committee or similar body requiring or threatening the termination, suspension or material modification of any Company Studies or Trials 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 no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who is participating or has participated in the Company Studies and Trials. In using or disclosing patient information received by the Company, if any, Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder (“HIPAA”)thereunder. To Except as disclosed in the Registration Statement and Prospectus, to the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or a comparable foreign regulatory authority to have engaged in scientific misconduct misconduct. To the knowledge of the Company, the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not reasonably be expected, individually or violations in the aggregate, to result in a Material Adverse Effect. The Company has provided the Underwriters with all material written notices, correspondence and summaries of good clinical practicesall other communications from the Regulatory Authorities. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and regulations policies of the FDA Regulatory Authorities. Neither the Company nor its subsidiaries or any of their respective employees, officers, directors, or, except as disclosed in the Registration Statement and comparable regulatory agencies outside Prospectus, their respective agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the United States Company and its subsidiaries, is subject to which the Company is subjecta governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension or exclusion.