Common use of Preclinical Studies and Clinical Trials Clause in Contracts

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would reasonably call into question in any material respect the results of the preclinical studies and clinical trials described in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and or clinical trials conducted by, by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the ProspectusProspectus (the “Company Studies and Trials”) were and, as applicable, were, and if still pending arepending, being are being, conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval submitted to the FDA and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable foreign regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effectauthority; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, the General Disclosure Package or the and Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into in question in any material respect the results of the preclinical studies and clinical trials described in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence with the FDA or any foreign, state or (ii) local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any preclinical studies Company Studies or clinical trials Trials that termination, suspension or material modification would cause them reasonably be expected to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or debarred by the FDA. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical Studies and Clinical Trials. The preclinical studies and or clinical trials conducted by, by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described inin the Prospectus (the “Company Studies and Trials”) were and, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending arepending, being are being, conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval submitted to the FDA and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable foreign regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effectauthority; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies the Company Studies and trials Trials contained in the Prospectus are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would reasonably are inconsistent with or call into in question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Prospectus; and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have has not received any written noticenotices or correspondence with the FDA or any foreign, correspondence state or other communications from local governmental body exercising comparable authority, requiring the Regulatory Authorities requiring or threatening (i) the termination or termination, suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies Company Studies or clinical trials Trials that termination, suspension or material modification would cause them reasonably be expected to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or debarred by the FDA. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, participated that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA Regulatory Authorities and comparable drug regulatory agencies outside of the United States to which they are subject current Good Clinical Practices and Good Laboratory Practices; (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are are, to the knowledge of the Company, accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus the results of which are inconsistent with or which the Company reasonably believes call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, the results modification or suspension of which would reasonably call into question in any material respect the results of the preclinical pre-clinical studies and or clinical trials that are described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The studies, tests and preclinical studies and or clinical trials conducted by, by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the ProspectusProspectus (the “Company Studies and Trials”) were and, as applicable, were, and if still pending arepending, being are being, conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval submitted to the FDA and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable foreign regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effectauthority; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, the General Disclosure Package or the and Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge Knowledge of any other preclinical studies or clinical trials that were conducted by or on behalf of the Company and that were not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into in question in any material respect the results of the preclinical studies and clinical trials described in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence with the FDA or any foreign, state or (ii) local governmental body exercising comparable authority requiring the termination, suspension or material modification of any preclinical studies Company Studies or clinical trials Trials that termination, suspension or material modification would cause them reasonably be expected to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, participated that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are are, to the knowledge of the Company, accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus the results of which are inconsistent with or which the Company reasonably believes call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence from the regulatory authorities or any other governmental agency requiring or threatening the termination, the results modification or suspension of which would reasonably call into question in any material respect the results of the preclinical pre-clinical studies and or clinical trials that are described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries 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 Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, trials and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA FDA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and any and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or and trials in all material respectsand known at the time of disclosure; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of developmentProspectus; neither the Company nor its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other Governmental Agency requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company is taking all reasonable steps necessary to ensure that its clinical trials will be conducted in accordance with any conditions of approval and policies imposed by Regulatory Authorities for such clinical trials.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject subject, including the U.S. Food and Drug Administration and the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe Registration Statement; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries Company, has participated, participated that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Statement and the Prospectus, 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA Regulatory Authorities and comparable drug regulatory agencies outside of the United States to which they are subject current Good Clinical Practices and Good Laboratory Practices; (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, Prospectus the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the current state of developmentProspectus; neither (iv) the Company nor its subsidiaries have 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; (v) the Company has provided the Sales Agent with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) the Company has not received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical pre-clinical studies or and clinical trials that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the SEC Reports, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the SEC Reports, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject subject, including the U.S. Food and Drug Administration and the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus SEC Reports of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe SEC Reports; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, the results of which would reasonably are inconsistent with or call into question in any material respect the results described or referred to in the SEC Reports; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the preclinical studies and clinical trials described Regulatory Authorities, except that where such non-compliance would not, individually or in the Registration Statementaggregate, the General Disclosure Package have a Material Adverse Effect; and the Prospectus when viewed in the context in which such results are described and the current state of development; (v) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the SEC Reports or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject subject, including the U.S. Food and Drug Administration and the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe Registration Statement; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided Guggenheim Securities with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the current state of development; (v) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state and federal lawsstatutes, rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Lawsstatutes, except as would not, singly or in rules and regulations of the aggregate, reasonably be expected to have a Material Adverse EffectRegulatory Authorities and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusIssuer Free Writing Prospectuses, if any, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Prospectus and the Prospectus when viewed Issuer Free Writing Prospectuses, if any; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or planned clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or its subsidiaries any such subsidiary has participated, that are described in, or the results of which are referred to 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 Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) except where the failure to be so in compliance has not resulted and all other applicable Health Care Laws, except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstrials; neither the Company nor any of its subsidiaries has no any knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor any of its subsidiaries have has received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, Prospectus or (ii) the material modification of any preclinical studies or and clinical trials that would cause them to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the SEC Reports, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the SEC Reports, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject subject, including the FDA and the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus SEC Reports of the results of such studies and trials are accurate and not misleading descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe SEC Reports; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, the results of which would reasonably call into question in any material respect are inconsistent with or raise substantial doubt regarding the results described or referred to in the SEC Reports; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the preclinical studies and clinical trials described Regulatory Authorities, except that where such non-compliance would not, individually or in the Registration Statementaggregate, the General Disclosure Package have a Material Adverse Effect; and the Prospectus when viewed in the context in which such results are described and the current state of development; (v) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the SEC Reports or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the SEC Reports, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the SEC Reports, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject (such institutional review boardssubject, ethics review boards, committees, including the FDA, FDA and the EMA or any comparable regulatory agencies, (collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus SEC Reports of the results of such studies and trials are accurate and not misleading descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe SEC Reports; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, the results of which would reasonably call into question in any material respect are inconsistent with the results described or referred to in the SEC Reports; (iv) the Company and its subsidiaries have, since January 1, 2020, operated and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the preclinical studies and clinical trials described Regulatory Authorities, except that where such non-compliance would not, individually or in the Registration Statementaggregate, the General Disclosure Package have a Material Adverse Effect; and the Prospectus when viewed in the context in which such results are described and the current state of development; (v) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the SEC Reports or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by on behalf of, or sponsored by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participatedhave participated with respect to their product candidates, that are described inin the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and or the Prospectus, as applicable, were, and if still pending arepending, are being conducted in accordance with the experimental protocols established for each study or trialall material respects, as well as any conditions of approval and all applicable laws, rules, regulations and policies imposed enforced by the FDA or any comparable Governmental Authority, or by any institutional review board, ethics review board or committee committee, in each case having authority or responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject trials (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect); the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has or its subsidiaries have no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the any Regulatory Authorities Authority requiring or threatening (iA) the termination or termination, suspension or clinical hold of any preclinical studies or clinical trials that are described inbeing conducted by or on behalf of, or the results of which are referred to insponsored by, the Registration Statement, Company or its subsidiaries or in which the General Disclosure Package and the ProspectusCompany or its subsidiaries are participating, or (iiB) the material adverse modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions are described in the Registration Statement, the General Disclosure Package and or the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trialsubmitted to the U.S. Food and Drug Administration (the “FDA”), as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trialsEuropean Medicines Agency (the “EMA”), and all other applicable localregulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject EMA) (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”), the applicable rules and regulations of the Regulatory Authorities, and current Good Clinical Practices and Good Laboratory Practices; (ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of the context in which such results are described Regulatory Authorities; (v) the Company has provided the Agent with all material written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The Except as disclosed in the General Disclosure Package and the Final Prospectus, (i) the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, subsidiaries or in which the Company or its subsidiaries has have participated, that are described inin the General Disclosure Package and the Final Prospectus, or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the Final Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care LawsGood Clinical Practices and Good Laboratory Practices, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effectapplicable; (ii) the descriptions in the Registration Statement, the General Disclosure Package or and the Final Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed Final Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the context in which such results are described Regulatory Authorities; and the current state of development; (v) neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical pre-clinical studies or clinical trials that are described in, in the General Disclosure Package and the Final Prospectus or the results of which are referred to in, the Registration Statement, in the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus, other than ordinary course written communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Offering Materials and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, participated that are described inin the Registration Statement, the Offering Materials and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Offering Materials 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA Regulatory Authorities and comparable drug regulatory agencies outside of the United States to which they are subject current Good Clinical Practices and Good Laboratory Practices; (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or Offering Materials and the Prospectus of the results of such studies and trials are are, to the knowledge of the Company, accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Offering Materials and the Prospectus, Prospectus the results of which would are inconsistent with or which the Company reasonably believes call into question in any material respect the results described or referred to in the Registration Statement, the Offering Materials and the Prospectus; and (iv) the Company has not received any written notices or correspondence from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of the preclinical any pre-clinical studies and or clinical trials that are described in the Registration Statement, the General Disclosure Package Offering Materials and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Offering Materials and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or its subsidiaries any such subsidiary has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Pricing Disclosure Package and the ProspectusProspectus Supplement, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Supplement, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) except where the failure to be so in compliance has not resulted and all other applicable Health Care Laws, except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; the descriptions in the Registration Statement, the General Pricing Disclosure Package or the Prospectus Supplement of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstrials; neither the Company nor any of its subsidiaries has no any knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the ProspectusProspectus Supplement, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus Supplement when viewed in the context in which such results are described and the current state of development; neither the Company nor any of its subsidiaries have has received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus Supplement or (ii) the material modification of any preclinical studies or and clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the ProspectusProspectus Supplement, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or its subsidiaries any such subsidiary has participated, that are described in, or the results of which are referred to in, the Registration StatementStatement and the Prospectus, or the General Disclosure Package 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 with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) except where the failure to be so in compliance has not resulted and all other applicable Health Care Laws, except as would notnot reasonably be expected to, singly or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package Statement or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstrials; neither the Company nor any of its subsidiaries has no any knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor any of its subsidiaries have has received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package Statement and the Prospectus, Prospectus or (ii) the material modification of any preclinical studies or and clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, that are described inin the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and or the Prospectus, as applicable, were, and if still pending arepending, are being conducted in all respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all accepted professional and scientific standards, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA FDA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and do not misleading in all contain any misstatement of a material respects with respect fact or omit to the portions of state a material fact necessary to make such studies and trials being described statements not misleading, and fairly present the data derived from such studies or trials in all material respectstrials; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have has not received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies research studies, clinical trials or clinical trials that are described inregistries conducted by or on behalf of, or the results of which are referred to insponsored by, the Registration Statement, Company or in which the General Disclosure Package and the ProspectusCompany has participated, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development, submissions or reports to any regulatory authority that could be expected to require investigation, corrective action or enforcement action, except for such violation that would not, singly or in the aggregate, result in a Material Adverse Effect.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted byby or on behalf of the Company or its subsidiaries that are described in the Registration Statement and the Prospectus were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations, including foreign laws and regulations, to which such preclinical studies and clinical trials are subject, and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the preclinical studies and clinical trials, if any, conducted by or, to the Company’s knowledge, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or and the results of which are referred to inthereof, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions contained in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such preclinical studies or trials in all material respectsand clinical trials, if any; the Company has no knowledge is not aware of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectustrials, the results of which would reasonably call into question in any material respect the results of the preclinical studies and clinical trials described in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described Prospectus; and the current state of development; neither the Company nor any of its subsidiaries have received any written notice, notices or correspondence or other communications from the Regulatory Authorities FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or Ethics Committee requiring or threatening (i) the termination or suspension termination, suspension, material modification or clinical hold of any preclinical studies or clinical trials that are described inconducted by or on behalf of the Company or its subsidiaries. Neither the Company nor its subsidiaries, nor to the knowledge of the Company any of its or their respective officers, employees or directors, nor any of its or their respective agents or clinical investigators, has been excluded, suspended, disqualified or debarred from participation in any U.S. federal health care program or human clinical research or equivalent foreign program or research, or the results of which are referred is subject to ina governmental inquiry, the Registration Statementinvestigation, the General Disclosure Package and the Prospectusproceeding, or (ii) the material modification other similar action that would reasonably be expected to result in debarment, disqualification, suspension, or exclusion, or convicted of any preclinical studies crime or clinical trials engaged in any conduct that would cause them reasonably be expected to materially differ from their descriptions result in the Registration 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 preclinical studies debarment under 21 U.S.C. § 335a or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the samecomparable foreign law.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Prospectus and the Time of Sale Information, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has 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 Package Prospectus and the ProspectusTime of Sale Information, 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Prospectus and the Prospectus Time of Sale Information of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which would the Company believes are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Prospectus and the Prospectus when viewed Time of Sale Information; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariessubsidiary, or in which the Company or its subsidiaries subsidiary has participated, that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiary have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that were such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; and the current state of development; (v) neither the Company nor its subsidiaries have subsidiary, to the Company’s knowledge, has received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiariesSubsidiaries, or in which the Company or its subsidiaries Subsidiaries has participated, that are described in, in the SEC Reports or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, trials and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA FDA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and any and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus SEC Reports of the results of such studies and trials are accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or and trials in all material respectsand known at the time of disclosure; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectustrials, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of developmentSEC Reports; neither the Company nor its subsidiaries Subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other Governmental Authority requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package and the ProspectusSEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, and to the Company’s knowledge, there are no reasonable grounds for the same. The Company is taking all reasonable steps necessary to ensure that its clinical trials will be conducted in accordance with 16 any conditions of approval and policies imposed by Regulatory Authorities for such clinical trials.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Prospectus and the Time of Sale Information, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has 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 Package Prospectus and the ProspectusTime of Sale Information, 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Prospectus and the Prospectus Time of Sale Information of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which would the Company believes are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Prospectus and the Prospectus when viewed Time of Sale Information; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.. (uu)

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The All preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which that are material to the Company and its Subsidiary, taken as a whole, are or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge of any other preclinical studies or clinical trials not been adequately described in the Registration Statement, the General Disclosure Package and the ProspectusFinal Prospectus in all material respects, except where failure to do so would reasonably be expected to result in a material adverse effect. To the Company’s knowledge, the results of which would reasonably call into question in any material respect the results clinical trials and preclinical studies conducted by or on behalf of the preclinical studies Company and clinical trials its Subsidiary that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and the ProspectusFinal Prospectus were and, or (ii) if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the material modification of any jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical studies or and clinical trials that would cause them from which data will be submitted to materially differ from their support marketing approval. The descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of such trials are accurate and complete in all material respects and fairly present the data derived from such trials, and the Company has no knowledge of any large well-controlled clinical trial the aggregate results of which are inconsistent with or otherwise call into question the results of any clinical trial conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company has not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other than ordinary course communications with respect similar governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any clinical trial or preclinical study that is described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to modifications in connection with the design Registration Statement, the General Disclosure Package and implementation the Final Prospectus. Except as disclosed in the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company has not received any written notices or statements from the EMA, any European country or any other governmental agency, and otherwise has no knowledge or reason to believe, that (i) any clinical trial application for a potential product of such preclinical studies the Company is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, approval, permit or authorization to conduct any clinical trialstrial, and, including an investigational new drug application submitted to the Company’s knowledgeFDA, there are no reasonable grounds for of any potential product of the sameCompany has been, will be or may be suspended, revoked, modified or limited.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Pricing Disclosure Package, the Prospectus, and the French Listing Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries Company, has participated, participated that are described inin the Registration Statement, the Pricing Disclosure Package, the Prospectus, and the French Listing Prospectus or the results of which are referred to in, in the Registration Statement, the General Pricing Disclosure Package and Package, the Prospectus, and the French Listing 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA Regulatory Authorities and comparable drug regulatory agencies outside of the United States to which they are subject current Good Clinical Practices and Good Laboratory Practices; (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Pricing Disclosure Package or Package, the Prospectus, and the French Listing Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and Package, the Prospectus, and the French Listing Prospectus the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package Package, the Prospectus, and the Prospectus when viewed in the context in which such results are described and the current state of developmentFrench Listing Prospectus; neither (iv) the Company nor its subsidiaries have 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; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) the Company has not received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical pre-clinical studies or and clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package, the Prospectus, and the French Listing Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and Package, the Prospectus, and the French Listing Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, that are described inin the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package and or the Prospectus, as applicable, were, and if still pending arepending, are being conducted in all respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all accepted professional and scientific standards, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA FDA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and do not misleading in all contain any misstatement of a material respects with respect fact or omit to the portions of state a material fact necessary to make such studies and trials being described statements not misleading, and fairly present the data derived from such studies or trials in all material respectstrials; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which would are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have has not received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies research studies, clinical trials or clinical trials that are described inregistries conducted by or on behalf of, or the results of which are referred to insponsored by, the Registration Statement, Company or in which the General Disclosure Package and the ProspectusCompany has participated, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration 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 preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. There has not been any violation of applicable law or regulation by the Company in its product development, submissions or reports to any regulatory authority that could be expected to require investigation, corrective action or enforcement action.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Prospectus and the Time of Sale Information, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has 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 Package Prospectus and the ProspectusTime of Sale Information, 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 experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject subject, including the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Prospectus and the Prospectus Time of Sale Information of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which would the Company believes are inconsistent with or reasonably call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Prospectus and the Prospectus when viewed Time of Sale Information; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other 18 governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described inin the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has have participated, that are described inin the Registration Statement and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, all applicable statutes and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug applicable regulatory agencies outside of the United States to which they are subject subject, including the U.S. Food and Drug Administration and the European Medicines Agency (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse EffectGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and not misleading complete descriptions in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from therefrom as of the dates given for such studies or trials data in all material respectsthe Registration Statement; (iii) the Company has no knowledge of any other preclinical studies or clinical trials conducted by or on behalf of the Company not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the context in which such results are described aggregate, have a Material Adverse Effect; (v) the Company has provided Xxxxx with all substantive written notices, correspondence and summaries of all other communications from the current state of developmentRegulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, material modification or suspension or clinical hold of any preclinical studies or clinical trials that are described in, in the Registration Statement and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariesCompany, or in which the Company or its subsidiaries has participated, participated that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all respects in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are are, to the knowledge of the Company, accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus the results of which are inconsistent with or which the Company reasonably believes call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, the results modification or suspension of which would reasonably call into question in any material respect the results of the preclinical pre-clinical studies and or clinical trials that are described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the pre-clinical studies and clinical trials conducted byby or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiariessubsidiary, or in which the Company or its subsidiaries has participated, subsidiary have participated that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, in the Registration Statement, the General 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 for products or product candidates comparable to those being developed by the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, Company and all applicable local, state statutes and federal laws, all applicable rules and regulations of the FDA, the EMA Regulatory Authorities and comparable drug regulatory agencies outside of the United States to which they are subject current Good Clinical Practices and Good Laboratory Practices; (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”ii) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Pricing Disclosure Package or and the Prospectus of the results of such studies and trials are accurate and not misleading complete in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respectstherefrom; (iii) the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus the results of which would reasonably are inconsistent with or call into question in any material respect the results of the preclinical studies and clinical trials described or referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the current state of developmentProspectus; neither (iv) the Company nor 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; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) the Company or its subsidiaries subsidiary have not received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening (i) the termination termination, modification or suspension or clinical hold of any preclinical pre-clinical studies or clinical trials that are described inin the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. No investigational new drug application or comparable submission filed by or on behalf of the Company or its subsidiary with the FDA or any other Applicable Regulatory Authority has been terminated or suspended by the FDA or such other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a company trial. In using or disclosing patient information received by the Company or its subsidiary in connection with a company trial, the Company has complied with all applicable laws and regulatory rules or requirements, including, without limitation, HIPAA and the rules and regulations thereunder. To the Company’s knowledge, none of the Company’s trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or any other Applicable Regulatory Authority to have engaged in scientific misconduct.

Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA, the EMA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws, except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package Statement or the Prospectus of the results of such studies and trials are accurate and not misleading in all material respects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials in all material respects; the Company has no knowledge of any other preclinical studies or clinical trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which would reasonably call into question in any material respect the results of the preclinical studies and clinical trials described in the Registration Statement, the General Disclosure Package Statement and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension or clinical hold of any preclinical studies or clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package Statement and the Prospectus, or (ii) the material modification of any preclinical studies or clinical trials that would cause them to materially differ from their descriptions in the Registration Statement, the General Disclosure Package Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.