Common use of Clinical Trials Clause in Contracts

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (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 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 trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement 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 Regulatory Authorities; and 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 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, and, to the knowledge of the Company, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement Statement, and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (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 tests are accurate and complete in all material respects and fairly present the data derived from such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 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, and, to the knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company 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 in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and or the Prospectus 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 trialstrials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or and the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not 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 knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus 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; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement Statement, the Pricing Disclosure Package or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 or pre-clinical trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, and, to the best knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company 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 in the Registration Statement Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and Statement, the General Disclosure Package or the Prospectus 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 trialstrials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or Statement, the General Disclosure Package and the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not 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 Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package 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 knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The research, non-clinical and pre-clinical studies and clinical trials and tests conducted or being conducted by or on behalf of the Company or sponsored by the Company, any of its Subsidiaries or in which any of their respective product candidates have participated (collectively, the Company has participated, “Studies”) that are described in the Registration Statement and the Prospectusin, or the results of which are referred to in in, the Registration Statement and the ProspectusProspectus were and, as applicable, were, and if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and the protocols, procedures and controls pursuant to all applicable statutes, including the Federal Food, Drug, laws and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesAuthorizations; the descriptions in the Registration Statement and the Prospectus each description of the results of such studies and tests are Studies is accurate and complete in all material respects and fairly present presents the data derived from such trials; Studies, and the Company has and its Subsidiaries have no knowledge of any other trialsresearch, non-clinical studies or tests the results of which are inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement or and the Prospectus except as otherwise disclosed in the Registration Statement and the Prospectus; the Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the types of products being developed by the Company except as would not reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its Subsidiaries has received any written notice of, or correspondence from, any Governmental Authority requiring the termination, suspension or material modification of any Study; and the Company and its Subsidiaries have each operated at all times and is currently are in compliance in all material respects with all applicable statutesrules, rules regulations and regulations policies of the Regulatory all Governmental Authorities; and 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 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, and, to the knowledge of . To the Company’s knowledge, there the manufacturing facilities and operations of its suppliers are no reasonable grounds for the sameoperated in compliance in all material respects with all applicable laws and Authorizations.

Clinical Trials. The clinical and pre-clinical trials conducted by 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 the Registration Statement Statement, the General Disclosure Package and the Prospectus, Final Prospectus or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package and the Final Prospectus, as applicable, wereand are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, and were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 and Statement, the General Disclosure Package or the Final Prospectus 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 trials, trials the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or Statement, the General Disclosure Package and the Final Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not nor any of its subsidiaries have received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification termination or suspension or material modification, other than modifications customarily implemented during the drug development process, of any clinical or pre-clinical trials that are described in the Registration Statement Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement and Statement, General Disclosure Package or the Final Prospectus, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, wereand are intended to be submitted to Regulatory Authorities as a basis for product approval, and were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which it is subject (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 and or the Prospectus of the results of such studies and tests trials 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 trials, trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement or and the Prospectus; the Company has and its Subsidiaries have each operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company Company, nor any of its Subsidiaries, has not received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening authority which could lead to the termination, material modification 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 and the Prospectus, and, to the knowledge of the Company, and there are no reasonable grounds for the same.

Clinical Trials. The clinical studies, tests and pre-preclinical and clinical trials conducted by or on behalf of of, or sponsored by by, the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement and Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement and Statement, the Time of Sale Disclosure Package or the Prospectus, as applicablewere and, were, and if still pending arepending, are being conducted in all material respects in accordance with standard all applicable medical and scientific research standards and protocols, procedures and controls and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (Regulatory Agencies, including, without limitation, any foreign21 C.F.R. Parts 26, federal50, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively54, the “Regulatory Authorities”) 56, 58, 99 and Subchapter H and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of such studies studies, tests and tests are accurate trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of material fact or omit a material fact necessary to make such statements not misleading, and complete fairly present in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trialsstudies, tests or trials not described in the Disclosure Package and the Prospectus the results of which are inconsistent with or reasonably call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement Statement, the Time of Sale Disclosure Package or the Prospectus; and neither the Company nor any subsidiary has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and the Company has not received any written notices, correspondence notices or other communications correspondence from the any Regulatory Authorities Agency or any other governmental agency Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification or suspension of any clinical studies, tests or pre-preclinical or clinical trials that are described conducted by or on behalf of, or sponsored by, the Company or any of its subsidiaries or in which the Registration Statement Company or any of its subsidiaries has participated, other than ordinary course communications with respect to modifications in connection with the design and the Prospectus implementation of such studies or the results of which are referred to in the Registration Statement and the Prospectustrials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical preclinical tests and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectusin, or the results of which are referred to in in, the Registration Statement Statement, the Pricing Disclosure Package and the ProspectusProspectus were and, as applicable, were, and if still pending arepending, are being conducted in all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such test or trial, as the case may be, and with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practicesprocedures; the descriptions in the Registration Statement and the Prospectus each description of the results of such studies tests and tests are trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus is accurate and complete in all material respects and fairly present presents in all material respects the data derived from such tests and trials; , and the Company has and its subsidiary have no knowledge of any other trials, studies or tests the results of which are inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement or Statement, the Pricing Disclosure Package and the Prospectus; neither the Company nor its subsidiary has received any notices or other correspondence from 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 (collectively, the “Regulatory Agencies”) requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and the Company and its subsidiary have each operated at all times and is currently are in compliance in all material respects with all applicable statutesrules, rules regulations and regulations policies of the Regulatory Authorities; and 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 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, and, to the knowledge of the Company, there are no reasonable grounds for the sameAgencies.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, 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 the Registration Statement and the Prospectusin, or the results of which are referred to in in, the Registration Statement and or the ProspectusProspectus were and, as applicable, were, and if still pending arepending, 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, and with standard medical and scientific research standards and procedures and procedures, all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA United States Food and other applicable regulatory authorities Drug Administration (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the “FDA) (collectively”), the European Medicines Agency (the “Regulatory AuthoritiesEMA”), the Israel Ministry of Health (the “IMH”) and current other comparable regulatory agencies to which they are subject and Good Clinical Practices and Good Laboratory Practices; , except to the descriptions extent where failure to conduct in the Registration Statement and the Prospectus such manner would not result in a Material Adverse Change. Each description of the results of such studies and tests are trials contained in the Registration Statement or the Prospectus is accurate and complete in all material respects and fairly present presents the data derived from such studies and trials; , and the Company has or its subsidiaries have no knowledge of any other trials, 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 or and the Prospectus; the . 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 Regulatory Authorities; and the Company has its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities FDA, the EMA, the IMH or any committee thereof or from any other governmental U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or or, to the Company’s knowledge, threatening the termination, material suspension or 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 or the Prospectus. The Company and its subsidiaries have operated at all times and currently are in compliance in all material respects with all applicable statutes, andrules, to the knowledge regulations and policies of the Company, there are no reasonable grounds for the sameRegulatory Agencies.

Clinical Trials. The Except as described in the Registration Statement and the Prospectus, the clinical and pre-clinical trials conducted by or 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 in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable comparable regulatory authorities (includingagencies outside of the United States to which they are subject, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by including the FDA) 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 tests are accurate and complete descriptions in all material respects and fairly present the data derived from such trialstherefrom; the Company has no knowledge of any other trialstrials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement or and the Prospectus; the Company has and its Subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not 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 knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (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 tests are accurate and complete in all material respects and fairly present the data derived from such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 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, and, to the knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical studies, tests and pre-preclinical and clinical trials conducted by or on behalf of of, or sponsored by by, the CompanyCompany or its subsidiary, or in which the Company has or its subsidiary have participated, that are described in the Registration Statement and Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement and Statement, the Time of Sale Disclosure Package or the Prospectus, as applicablewere and, were, and if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) Agencies and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Time of Sale Disclosure Statement and the Prospectus 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 trialsstudies, tests or trials not described in the Time of Sale Disclosure Package and the Prospectus the results of which are inconsistent with or reasonably call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement Statement, the Time of Sale Disclosure Package or the Prospectus; and neither the Company nor its subsidiary has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and the Company has not received any written notices, correspondence or other communications notices from the any Regulatory Authorities Agency or any other governmental agency institutional review board requiring or threatening the termination, suspension or material modification or suspension of any clinical studies, tests or pre-preclinical or clinical trials that are described conducted by or on behalf of, or sponsored by, the Company or in which the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the ProspectusCompany has participated, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, wereand are intended to be submitted to Regulatory Authorities as a basis for product approval, and were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which it is subject (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 and Statement, the Disclosure Package or the Prospectus of the results of such studies and tests trials 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 trials, trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement or Statement, Disclosure Package and the Prospectus; the Company has and its subsidiaries have each operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company Company, nor any of its subsidiaries, has not received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening authority which could lead to the termination, material modification 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 and the Prospectus, and, to the knowledge of the Company, and there are no reasonable grounds for the same.

Clinical Trials. The clinical clinical, preclinical and pre-clinical nonclinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus 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; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement Statement, the Pricing Disclosure Package or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 clinical, preclinical or pre-clinical nonclinical trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, and, to the best knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company 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 in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the ProspectusProspects, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable comparable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and or the Prospectus of the results of such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived from such trialstherefrom; the Company has no knowledge of any other trialstrials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or and the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not 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 knowledge of the Company’s best knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, Company or in which the Company has participated, that are described in the Registration Statement and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, wereand are intended to be submitted to Regulatory Authorities and in certain cases serve as a basis for product approval, and were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which it is subject (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 and or the Prospectus of the results of such studies and tests trials 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 trials, trials the results of which are inconsistent with or otherwise reasonably call into question the results described or referred to in the Registration Statement or Statement, and the Prospectus; the Company has and its Subsidiaries have each operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company Company, nor any of its Subsidiaries, has not received any written notices, correspondence or other communications written communication from the Regulatory Authorities or any other governmental agency requiring or threatening authority which could reasonably be expected to lead to the termination, material modification 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 and the Prospectus, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, werewere and, and if still pending arepending, are being conducted in all material respects US-DOCS\95271282.8 in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 and the Prospectus of the results of such studies and tests trials 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 trials, trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement or and the Prospectus; the Company has and its subsidiaries have each operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries has not received any written noticesnotice, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening authority which could lead to the termination, material modification 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 and the Prospectus, and, to the knowledge of the Company, and there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by 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 the Registration Statement and the Prospectus, Offering Memorandum or the results of which are referred to in the Registration Statement Offering Memorandum and the Prospectuswhich were submitted to Regulatory Authorities as a basis for product approval, as applicable, were, and if still pending are, being were conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which it is subject (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 and the Prospectus Offering Memorandum 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 trials, trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement or the ProspectusOffering Memorandum; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not nor any of its subsidiaries have received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening which could lead to the termination, material modification termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus Offering Memorandum or the results of which are referred to in the Registration Statement and the ProspectusOffering Memorandum, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus 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; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement Statement, the Pricing Disclosure Package or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 or pre-clinical trials that are described in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the Pricing Disclosure Package and the Prospectus, and, to the knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical trials and pre-clinical trials preclinical studies conducted by or or, to the knowledge of the Company 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 in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA U.S. Food and other applicable Drug Administration and comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 the clinical trials and preclinical studies and tests conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries contained in the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trialstrials and studies; the Company has no knowledge of any other trialstrials not described in the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations laws of the Regulatory Authorities; and except as disclosed in the Prospectus, neither the Company has not 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 trials or pre-clinical trials preclinical studies 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, and, other than ordinary course communications with respect to modifications in connection with the knowledge design and implementation of the Company, there are no reasonable grounds for the samesuch trials.

Clinical Trials. The clinical trials and pre-clinical trials preclinical studies conducted by or or, to the knowledge of the Company 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 in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA U.S. Food and other applicable Drug Administration and comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 the clinical trials and preclinical studies and tests conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries contained in the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trialstrials and studies; the Company has no knowledge of any other trialstrials not described in the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations laws of the Regulatory Authorities; and neither the Company has not 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 trials or pre-clinical trials preclinical studies 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, and, other than ordinary course communications with respect to modifications in connection with the knowledge design and implementation of the Company, there are no reasonable grounds for the samesuch trials.

Clinical Trials. The clinical trials and pre-clinical trials preclinical studies conducted by or or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical industry practice and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all any applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 trials and studies and tests contained in the Registration Statement or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trialstrials and studies; the Company has no knowledge of any other trialstrials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement or and 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 Applicable Laws of the Regulatory Authorities; and the Company has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency with jurisdiction over it requiring or threatening the termination, material modification or suspension of any clinical trials or pre-clinical trials preclinical studies 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 knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (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 tests are accurate and complete in all material respects and fairly present the data derived from such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 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, and, to the knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.. ​ ​

Clinical Trials. The (1) the clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (2) the descriptions in the Registration Statement and the Prospectus of the results of such studies and tests are accurate and complete and fairly present in all material respects and fairly present the data derived from such trials; (3) neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; (4) the Company has operated at all times and is each of its subsidiaries are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (5) neither the Company nor any of its subsidiaries 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 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, and, to the knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical clinical, preclinical and pre-clinical nonclinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (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 tests are accurate and complete in all material respects and fairly present the data derived from such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has and each of its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company nor any of its subsidiaries 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 clinical, preclinical or pre-clinical nonclinical 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, and, to the best knowledge of the CompanyCompany and its subsidiaries, there are no reasonable grounds for the same.

Clinical Trials. The clinical clinical, preclinical and pre-clinical nonclinical trials and studies conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards their protocols and procedures and in material compliance with all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory PracticesPractices (as defined by the FDA), as applicable; the descriptions in the Registration Statement and the Prospectus of the results of such studies and tests are accurate and complete in all material respects and fairly materially present the data derived from such trialstrials or studies; the Company has no knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement 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 Regulatory Authorities; and the Company has not received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical, clinical or pre-clinical nonclinical 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, and, to the knowledge of the Company, there are no reasonable grounds for the same.. (ss)

Clinical Trials. The clinical trials and pre-clinical trials preclinical studies conducted by or or, to the knowledge of the Company 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 in the Registration Statement Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which they are subject (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 the clinical trials and preclinical studies and tests conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trialstrials and studies; the Company has no knowledge of any other trialstrials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or Statement, the General Disclosure Package and the Prospectus; the Company has and its subsidiaries have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules and regulations Applicable Laws of the Regulatory Authorities; and neither the Company has not 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 trials or pre-clinical trials preclinical studies that are described in the Registration Statement Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement Statement, the General Disclosure Package 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 knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. (i) The clinical and pre-clinical trials conducted by or 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 the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, including the Federal Food, Drug, and Cosmetic Act, statutes and all applicable rules and regulations of the FDA and other applicable comparable regulatory authorities (includingagencies outside of the United States to which they are subject, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by including the FDA) 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 and tests are accurate and complete descriptions in all material respects and fairly present the data derived from such trialstherefrom; (iii) the Company has no knowledge of any other trialstrials not described in the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement or and the Prospectus; (iv) 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 Regulatory Authorities; 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 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 Prospectus, other than ordinary course communications with respect to modifications in connection with the design and the Prospectusimplementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or its subsidiary, or in which the Company has or its subsidiary have participated, that are described in the Registration Statement and the Prospectus, SEC Reports or the results of which are referred to in the Registration Statement and the ProspectusSEC Reports were and, as applicable, were, and if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all applicable statutes, including the Federal Foodrules, Drug, regulations and Cosmetic Act, and all applicable rules and regulations policies of the FDA U.S. Food and other applicable Drug Administration (the “FDA”) and comparable drug regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar agencies outside of the United States to those performed by the FDA) which it is subject (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 and the Prospectus SEC Reports 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; trials and the Company has no knowledge of any other trials, trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement or the ProspectusSEC Reports; the Company has and its subsidiary have operated at all times and is are currently in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations policies of the Regulatory Authorities; and neither the Company has not nor its subsidiary have received any written notices, correspondence or other communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening which could lead to the termination, material modification termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus SEC Reports or the results of which are referred to in the Registration Statement and the Prospectus, SEC Reports and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same.