Common use of Clinical Trials Clause in Contracts

Clinical Trials. The pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) and comparable regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is accurate and complete in all material respects, and the Company has no knowledge of any other studies or trials the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Agencies.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company, or in which the Company has participated, that are described inin the Registration Statement, the Time of Sale Prospectus and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageTime of Sale Prospectus and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, standard medical and scientific research procedures and all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable drug regulatory agencies outside of the United States to which they are it is subject applicable to pre-clinical (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Time of Sale Prospectus or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description the Prospectus of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is are accurate and complete in all material respects, and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials 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 General Disclosure PackageTime of Sale Prospectus and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of the Prospectus or Regulatory Authorities; neither the Company, nor any Written Testing-the-Waters Communication. The Company of its Subsidiaries, has not received any written notices, correspondence or other communications communication from the FDA Regulatory Authorities or any committee thereof governmental authority which could lead to the termination or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Prospectus or the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package, the Time of Sale Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times the Prospectus, and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Agenciesthere are no reasonable grounds for same.

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company’s knowledge, (x) on behalf of or sponsored by the CompanyCompany or its subsidiaries, or (y) in which the Company has or its subsidiaries have participated, that are described inin the Registration Statement, the Prospectus, and the Time of Sale Information, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageProspectus, and the Prospectus or any Written Testing-the-Waters Communication were andTime of Sale Information, as applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study Company or trial, as the case may be, its subsidiaries and all applicable statutes, statutes and all rules and regulations of the United States Food FDA and Drug Administration (the “FDA”) and other comparable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Information of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is tests are accurate and complete descriptions in all material respects, respects and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials trials, the results of which the Company believes are inconsistent with, with or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The the Time of Sale Information; the Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has and its subsidiaries have operated at all times and is currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory AgenciesAuthorities; the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, in the Registration StatementStatement and the Prospectus, the General Disclosure Packageas applicable, the Prospectus or any Written Testing-the-Waters Communication and are intended to be submitted to regulatory authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with their protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, and all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which they are it is subject applicable to pre-clinical (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description the Prospectus of the results of such studies clinical and preclinical trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is are accurate and complete in all material respects, respects and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials the results of which are inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration Statement, Statement and the General Disclosure Package, Prospectus; the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that and its subsidiaries have operated and are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies Applicable Laws of the Regulatory AgenciesAuthorities; neither the Company nor its subsidiaries have received any written notices, correspondence or other written communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for same.

Clinical Trials. The pre-clinical studies and clinical trials and preclinical studies conducted by or, to the knowledge of the CompanyCompany after due inquiry, on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described inin the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication were andas applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable drug regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such trials and studies and trials contained in the Registration Statement, the General Disclosure Package, Package or the Prospectus or any Written Testing-the-Waters Communication is are accurate and complete in all material respects, respects and fairly present the data derived from such trials and studies; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General 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 General Disclosure Package, Package and the Prospectus or Prospectus; the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Laws of the Regulatory Authorities; neither the Company nor any Written Testing-the-Waters Communication. The Company has not of its subsidiaries have received any written notices, correspondence or other communications from the FDA Regulatory Authorities or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory governmental agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, material modification or suspension or modification of any clinical trials or preclinical studies that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, other than ordinary course communications with respect to modifications in connection with the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times design and currently is in compliance in all material respects with all applicable statutesimplementation of such trials, rulesand, regulations and policies of to the Regulatory AgenciesCompany’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company’s knowledge, (x) on behalf of or sponsored by the CompanyCompany or its subsidiaries, or (y) in which the Company has or its subsidiaries have participated, that are described inin the Registration Statement, the Prospectus, and the Time of Sale Information, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageProspectus, and the Prospectus or any Written Testing-the-Waters Communication were andTime of Sale Information, as applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study Company or trial, as the case may be, its subsidiaries and all applicable statutes, statutes and all rules and regulations of the United States Food FDA and Drug Administration (the “FDA”) and other comparable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Information of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is tests are accurate and complete descriptions in all material respects, respects and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials trials, the results of which the Company believes are inconsistent with, with or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The the Time of Sale Information; the Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has and its subsidiaries have operated at all times and is currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory Agencies.Authorities; the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, and, to the Company’s knowledge, there are no reasonable grounds for the same. ​ ​

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company, or in which the Company has participated, that are described inin the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication were andas applicable, were, and if still pendingpending are, are being conducted conducted, in all material respects respects, in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, standard medical and scientific research standards and procedures and all applicable statutes, statutes and all rules and regulations of the United States U.S. Food and Drug Administration (the “FDA”) and comparable other applicable regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state, provincial or local governmental or regulatory authority performing functions similar to those performed by the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description of FDA) (collectively, the results of such studies “Regulatory Authorities”) and trials contained current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package, Package and the Prospectus or any Written Testing-the-Waters Communication is of the results of such studies and tests are accurate and complete in all material respects, and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials trials, 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 General Disclosure PackagePackage or the Prospectus; the Company has operated at all times and is currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the Prospectus or any Written Testing-the-Waters Communication. The Regulatory Authorities; the Company has not received any written notices, correspondence or other communications from the FDA Regulatory Authorities or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory governmental agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, modification or suspension or modification of any clinical or pre-clinical trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, and, to the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutesCompany’s knowledge, rules, regulations and policies of there are no reasonable grounds for the Regulatory Agenciessame.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, 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 General Disclosure Packageas applicable, the Prospectus or any Written Testing-the-Waters Communication were andwere, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for its investigational products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study or trial, as the case may be, Company and all applicable statutes, statutes and all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is tests are accurate and complete descriptions in all material respects, respects and fairly present the data derived therefrom; 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, with or otherwise call into question, question the results described or referred to in the Registration Statement, Statement and the General Disclosure Package, Prospectus; the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has and its subsidiaries have operated at all times and are currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory AgenciesAuthorities; neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in, in the Prospectus or the results of which are referred to in, in the Registration StatementStatement and the Prospectus, the General Disclosure Packageas applicable, the Prospectus or any Written Testing-the-Waters Communication and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are are, except as would not individually or in the aggregate have a Material Adverse Effect, being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, standard medical and scientific research procedures and all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable drug regulatory agencies outside of the United States to which they are it is subject applicable to pre-clinical (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description the Prospectus of the results of such studies and trials contained in the Registration Statementare accurate and, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is accurate and complete in all material respects, complete and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials the results of which are inconsistent with, with or otherwise call into question, question the results described or referred to in the Registration StatementStatement and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the General Disclosure PackageRegulatory Authorities; and neither the Company, the Prospectus or nor any Written Testing-the-Waters Communication. The Company of its Subsidiaries, has not received any written notices, correspondence or other communications communication from the FDA Regulatory Authorities or any committee thereof governmental authority which could lead to the termination or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical or pre-clinical trials that are described in the Prospectus or the results of which are referred to in the Registration StatementProspectus, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Agenciesthere are no reasonable grounds for same.

Clinical Trials. (i) The clinical trials and pre-clinical studies research and clinical trials development activities conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated, that are described inin the Prospectus, or the results of which are referred to inin the Prospectus, the Registration Statementas applicable, the General Disclosure Packagewere, the Prospectus or any Written Testing-the-Waters Communication were and, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study or trial, as the case may be, Company and all applicable statutes, statutes and all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), and current Good Clinical Practices and Good Laboratory Practices, as applicable; (ii) the descriptions in the Registration Statement and the Prospectus of the results of such studies trials and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testingpre-the-Waters Communication is clinical research and development activities are accurate and complete descriptions in all material respects, respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or Company-sponsored trials and research and development activities not described in 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, Statement and the General Disclosure Package, Prospectus; (iv) the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and is currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory AgenciesAuthorities; and (v) except as described in the Prospectus, the Company has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical trials or pre-clinical research and development activities that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The pre-clinical studies and clinical trials and preclinical studies conducted by or, to the knowledge of the CompanyCompany after due inquiry, on behalf of or sponsored by the Company, or in which the Company has participated, 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 General Disclosure Packageas applicable, the Prospectus or any Written Testing-the-Waters Communication were andwere, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, all standard industry practice and any applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable drug regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such trials and studies and trials contained in the Registration Statement, the General Disclosure Package, Statement or the Prospectus or any Written Testing-the-Waters Communication is are accurate and complete in all material respects, respects and fairly present the data derived from such trials and studies; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with, or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, Statement and the General Disclosure Package, Prospectus; the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and is currently in compliance in all material respects with all Applicable Laws of the Regulatory Authorities; and the Company has not received any written notices, correspondence or other communications from the FDA Regulatory Authorities or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory governmental agency (collectively, the “Regulatory Agencies”) with jurisdiction over it requiring or threatening the termination, material modification or suspension or modification of any clinical trials or preclinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration StatementStatement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the General Disclosure Packagedesign and implementation of such trials, and, to the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutesCompany’s knowledge, rules, regulations and policies of there are no reasonable grounds for the Regulatory Agenciessame.