Common use of Preclinical Studies and Clinical Trials Clause in Contracts

Preclinical Studies and Clinical Trials. The preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the 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 local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to 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 or and clinical trials conducted by or 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 in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus 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 “Company Studies and TrialsRegulatory Authorities”) were andand all other applicable Health Care Laws, if still pendingexcept 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 being, conducted accurate and not misleading in all material respects in accordance with the protocols submitted respect to the FDA portions of such studies and any comparable foreign regulatory authority; trials being described and fairly present the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate 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 are inconsistent with or would reasonably call into question in question 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 in, the Registration Statement, the General Disclosure Package and the Prospectus; and , or (ii) the Company has not received any written notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies preclinical studies or Trials clinical trials that terminationwould cause them to materially differ from their descriptions in the Registration Statement, suspension 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 material modification would reasonably be expected to have a Material Adverse Effect clinical trials, 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 or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted to Company and all applicable statutes and all applicable rules and regulations of the FDA Regulatory Authorities and any comparable foreign regulatory authoritycurrent Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and trials are, to the Company Studies knowledge of the Company, accurate and Trials contained in the General Disclosure Package and Prospectus are accurate complete in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus the results of which are inconsistent with or which the Company reasonably believes call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence with from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, modification or suspension or material modification of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the Pricing Disclosure Package and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Pricing Disclosure Package and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to 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 local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to 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 studies, tests and preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge Knowledge of any other studies or 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 are inconsistent with or call in question the results described or referred to 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 local governmental body exercising comparable authority, authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to 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 knowledgeKnowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or debarred has been found by the FDAFDA 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 or and clinical trials conducted by or 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 have participated, that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (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) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authorityall applicable Health Care Laws; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and trials are, to the Company Studies knowledge of the Company, accurate and Trials contained in the General Disclosure Package and Prospectus are accurate complete in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus the results of which are inconsistent with or which the Company reasonably believes call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence with from the FDA regulatory authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, modification or suspension or material modification of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the Pricing Disclosure Package and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Pricing Disclosure Package and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 and the Prospectus, the pre-clinical studies or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company Company, or in which the Company, has participated that are described in the General Disclosure Package Registration Statement and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement and Trials”) were andthe Prospectus as applicable, were, and if still pendingpending are, are being, 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 protocols submitted to Company and all applicable statutes and all applicable rules and regulations of the FDA Regulatory Authorities and any comparable foreign regulatory authoritycurrent Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, Prospectus the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; (iv) the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; (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 notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, suspension or material modification or suspension of any Company Studies pre-clinical studies and clinical trials that are described in the Registration Statement and the Prospectus or Trials that terminationthe results of which are referred to in the Registration Statement and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, suspension or material modification would reasonably be expected to 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 (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA U.S. Food and any comparable foreign regulatory authorityDrug Administration and the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the Registration Statement; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (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) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or 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 the Registration Statement, the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were andProspectus, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of or the results of which are referred to in the Company Studies and Trials contained in 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 rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA or any comparable regulatory agencies, collectively, the “Regulatory Authorities”) and any and all applicable Health Care Laws; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate and complete in all material respectsrespects and fairly present the data derived from such studies and trials and 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 are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and neither the Company has not nor its subsidiaries have received any written notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other Governmental Agency requiring or local governmental body exercising comparable authority, requiring threatening (i) the termination, 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 Company Studies preclinical studies or Trials clinical trials that terminationwould cause them to materially differ from their descriptions in the Registration Statement, suspension 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 material modification would reasonably be expected to have a Material Adverse Effect clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused is taking all reasonable steps necessary to ensure that its clinical trials will be obtained) informed consent conducted in accordance with any conditions of approval and policies imposed 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 Regulatory Authorities for such 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 subjecttrials.

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 or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement, the Prospectus and the Time of Sale Information, or the results of which are referred to in the Registration Statement, the Prospectus (and the “Company Studies Time of Sale Information, as applicable, were, and Trials”) were and, if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Prospectus and the Time of Sale Information of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which the Company believes are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package Registration Statement, the Prospectus and the ProspectusTime of Sale Information; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other 18 governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA U.S. Food and any comparable foreign regulatory authorityDrug Administration and the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the Registration Statement; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in into question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided Xxxxx with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 (i) Except as described in the Registration Statement, the Prospectus and the Time of Sale Information, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement, the Prospectus and the Time of Sale Information, or the results of which are referred to in the Registration Statement, the Prospectus (and the “Company Studies Time of Sale Information, as applicable, were, and Trials”) were and, if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Prospectus and the Time of Sale Information of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which the Company believes are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package Registration Statement, the Prospectus and the ProspectusTime of Sale Information; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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.uu)

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 or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company Company, or in which the Company, has participated that are described in the General Registration Statement, the Pricing Disclosure Package Package, the Prospectus, and the French Listing Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package, the Prospectus, and Trials”) were andthe French Listing Prospectus as applicable, were, and if still pendingpending are, are being, 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 protocols submitted to Company and all applicable statutes and all applicable rules and regulations of the FDA Regulatory Authorities and any comparable foreign regulatory authoritycurrent Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package, the Prospectus, and the French Listing Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package Package, the Prospectus, and the French Listing Prospectus; (iv) the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; (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 notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, suspension or material modification or suspension of any Company Studies pre-clinical studies and clinical trials that are described in the Registration Statement, the Pricing Disclosure Package, the Prospectus, and the French Listing Prospectus or Trials that terminationthe results of which are referred to in the Registration Statement, suspension the Pricing Disclosure 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 studies or material modification would reasonably be expected to have a Material Adverse Effect trials, 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 or and clinical trials conducted by or by, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, being conducted in all material respects in accordance with the experimental protocols submitted to 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 studies and trials, all accepted professional and scientific standards, and all applicable local, state and federal laws, rules and regulations of the 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 or any comparable foreign regulatory authorityagencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading, and fairly present the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respectsdata derived from such studies or trials; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the ProspectusProspectus when viewed in the context in which such results are described and the current state of development; and the Company has not received any written notices notice, correspondence or correspondence with other communications from the FDA Regulatory Authorities requiring or any foreign, state threatening (i) the termination or local governmental body exercising comparable authority, requiring the termination, suspension or clinical hold of any research studies, clinical trials or clinical registries conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, or (ii) the material modification of any Company Studies studies or Trials trials that terminationwould cause them to differ from their descriptions in the Registration Statement, suspension 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 studies or material modification would reasonably be expected to have a Material Adverse Effect trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company There has obtained (not been any violation of applicable law 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 regulation by the Company in connection with the Company Studies and Trialsits product development, the Company has complied in all material respects with all applicable laws and submissions or reports to any regulatory rules authority that could be expected to require investigation, corrective action 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 subjectenforcement action.

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 or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authorityall applicable Health Care Laws, ; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and trials are, to the Company Studies knowledge of the Company, accurate and Trials contained in the General Disclosure Package and Prospectus are accurate complete in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus the results of which are inconsistent with or which the Company reasonably believes call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices or correspondence with from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, modification or suspension or material modification of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the Pricing Disclosure Package and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Pricing Disclosure Package and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or by, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, being conducted in all material respects in accordance with the experimental protocols submitted to 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 studies and trials, all accepted professional and scientific standards, and all applicable local, state and federal laws, rules and regulations of the 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 or any comparable foreign regulatory authorityagencies, collectively, the “Regulatory Authorities”) and all other applicable Health Care Laws; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading, and fairly present the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respectsdata derived from such studies or trials; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the ProspectusProspectus when viewed in the context in which such results are described and the current state of development; and the Company has not received any written notices notice, correspondence or correspondence with other communications from the FDA Regulatory Authorities requiring or any foreign, state threatening (i) the termination or local governmental body exercising comparable authority, requiring the termination, suspension or clinical hold of any research studies, clinical trials or clinical registries conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, or (ii) the material modification of any Company Studies studies or Trials trials that terminationwould cause them to differ from their descriptions in the Registration Statement, suspension 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 studies or material modification would reasonably be expected to have a Material Adverse Effect trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company There has obtained (not been any violation of applicable law 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 regulation by the Company in connection with 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 Company Studies and Trialsaggregate, the Company has complied result 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 subjectMaterial Adverse Effect.

Preclinical Studies and Clinical Trials. The All preclinical studies or and clinical trials conducted by or, to the knowledge of the Company, on behalf of the Company that are material to the Company and its Subsidiary, taken as a whole, are or have been adequately described in the Registration Statement, the General Disclosure Package and the Final 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 clinical trials and preclinical studies conducted by or on behalf of the Company and its Subsidiary 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 were and, if still ongoing, are being conducted in material compliance with all laws and regulations applicable thereto in the jurisdictions in which they are being conducted and with all laws and regulations applicable to preclinical studies and clinical trials from which data will be submitted to 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 (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of or the results of which are referred to in the Company Studies and Trials contained in Registration Statement, the General Disclosure Package and Prospectus are accurate the Final Prospectus. Except as disclosed in all material respects; the Registration Statement, the General Disclosure Package and the Final Prospectus, the Company has no knowledge not received any written notices or statements from the FDA, the European Medicines Agency (“EMA”) or any other similar governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of any other studies clinical trial or trials not preclinical study that is described in the Registration Statement, the General Disclosure Package and the Prospectus, Final Prospectus or the results of which are inconsistent with or call in question the results described or 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 correspondence with statements from the FDA EMA, any European country or any foreignother governmental agency, state and otherwise has no knowledge or local governmental body exercising comparable authorityreason to believe, requiring that (i) any clinical trial application for a potential product of the terminationCompany is or has been rejected or determined to be non-approvable or conditionally approvable; and (ii) any license, suspension approval, permit or material modification authorization to conduct any clinical trial, including an investigational new drug application submitted to the FDA, of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to 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 potential product 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 been, will be or requirementsmay be suspended, includingrevoked, 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 modified 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 subjectlimited.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (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) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or 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 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 General Disclosure Package and aggregate, reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement or the Prospectus (of the “Company Studies results of such studies and Trials”) were and, if still pending, trials are being, conducted accurate and not misleading in all material respects in accordance with the protocols submitted respect to the FDA portions of such studies and any comparable foreign regulatory authority; trials being described and fairly present the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate 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 are inconsistent with or would reasonably call into question in question any material respect the results of the preclinical studies and clinical trials described in the Registration 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 in, the General Disclosure Package Registration Statement and the Prospectus; and , or (ii) the Company has not received any written notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies preclinical studies or Trials clinical trials that terminationwould cause them to materially differ from their descriptions in the Registration Statement and the Prospectus, suspension other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or material modification would reasonably be expected to have a Material Adverse Effect clinical trials, 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 or and clinical trials conducted by or by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or any such subsidiary has participated, that are described in in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were andProspectus, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of or the results of which are referred to in the Company Studies and Trials contained in 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 (collectively, the “Regulatory Authorities”) except where the failure to be so in compliance has not resulted and would not reasonably be expected to, singly or in the aggregate, 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 respectsrespects with respect to the portions of such studies and trials being described and fairly present the data derived from such studies or trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results 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 has received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension of any preclinical studies 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 or (ii) the material modification of any preclinical studies and clinical trials that would cause them to differ from their descriptions in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence , other than ordinary course communications with respect to modifications in connection with the FDA design and implementation of such studies or any foreigntrials, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to 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 (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement and Trials”) were andthe Prospectus, as applicable, were, and if still pending, are beingare, 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 protocols submitted Company and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityall applicable statutes, rules and regulations of the Regulatory Authorities and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusIssuer Free Writing Prospectuses, if any, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package Registration Statement, the Prospectus and the ProspectusIssuer Free Writing Prospectuses, if any; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or planned clinical trials, 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 (i) Except as described in the SEC Reports, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package SEC Reports, or the results of which are referred to in the SEC Reports, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA U.S. Food and any comparable foreign regulatory authorityDrug Administration and the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Reports of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the SEC Reports; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the ProspectusSEC Reports; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; and (v) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the SEC Reports or the results of which are referred to in the SEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or any such subsidiary has participated, that are described in in, or the General results of which are referred to in, the Registration Statement, the Pricing Disclosure Package and the Prospectus 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 (collectively, the “Company Studies and TrialsRegulatory Authorities”) were andexcept where the failure to be so in compliance has not resulted and would not reasonably be expected to, if still pendingsingly or in the aggregate, result in a Material Adverse Effect; the descriptions in the Registration Statement, the Pricing Disclosure Package or the Prospectus Supplement of the results of such studies and trials are being, conducted accurate and not misleading in all material respects in accordance with the protocols submitted respect to the FDA portions of such studies and any comparable foreign regulatory authoritytrials being described and fairly present the data derived from such studies or trials; the descriptions of the results of neither the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the ProspectusProspectus Supplement, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; 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 has not received any written notices notice, correspondence or correspondence with other communications from the FDA Regulatory Authorities requiring or threatening (i) the termination or suspension of any foreignpreclinical studies and clinical trials that are described in, state or local governmental body exercising comparable authoritythe results of which are referred to in, requiring the terminationRegistration Statement, suspension the Pricing Disclosure Package and the Prospectus Supplement or (ii) the material modification of any Company Studies preclinical studies and clinical trials that would cause them to differ from their descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus Supplement, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to 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 (i) Except as described in the Registration Statement, the Prospectus and the Time of Sale Information, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement, the Prospectus and the Time of Sale Information, or the results of which are referred to in the Registration Statement, the Prospectus (and the “Company Studies Time of Sale Information, as applicable, were, and Trials”) were and, if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Prospectus and the Time of Sale Information of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Prospectus and the ProspectusTime of Sale Information, the results of which the Company believes are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package Registration Statement, the Prospectus and the ProspectusTime of Sale Information; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided the Agent with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 Offering Materials and the Prospectus, the pre-clinical studies or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, or in which the Company has participated that are described in the General Disclosure Package Registration Statement, the Offering Materials and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Offering Materials and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted to Company and all applicable statutes and all applicable rules and regulations of the FDA Regulatory Authorities and any comparable foreign regulatory authoritycurrent Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Offering Materials and the Prospectus of the results of such studies and trials are, to the Company Studies knowledge of the Company, accurate and Trials contained in the General Disclosure Package and Prospectus are accurate complete in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Offering Materials and the Prospectus, Prospectus the results of which are inconsistent with or which the Company reasonably believes call in into question the results described or referred to in the General Disclosure Package Registration Statement, the Offering Materials and the Prospectus; and (iv) the Company has not received any written notices or correspondence with from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, modification or suspension or material modification of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the Offering Materials and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Offering Materials and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 or and clinical trials conducted by or on behalf of the Company or its subsidiaries that are described in the General Disclosure Package Registration Statement and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA or any foreign governmental body exercising comparable authority, procedures and any comparable controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations, including foreign regulatory authoritylaws 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 results preclinical studies and clinical trials, if any, conducted by or, to the Company’s knowledge, on behalf of the Company Studies or its subsidiaries, and Trials the results thereof, contained in the General Disclosure Package Registration Statement and the Prospectus are accurate and complete in all material respectsrespects and fairly present the data derived from such preclinical studies and clinical trials, if any; the Company has no knowledge is not aware of any other preclinical studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectusclinical trials, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; and neither the Company has not nor any of its subsidiaries have received any written notices or correspondence with from the FDA or FDA, any foreign, state or local governmental body exercising comparable authority, authority or any Institutional Review Board or Ethics Committee requiring the termination, suspension or suspension, material modification or clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Company Studies or Trials 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 is subject to a governmental inquiry, investigation, proceeding, or other similar action that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect andresult in debarment, disqualification, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (result in debarment under 21 U.S.C. § 335a 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 subjectforeign law.

Preclinical Studies and Clinical Trials. The preclinical studies or and clinical trials conducted by or on behalf of of, or sponsored by, the Company or its subsidiaries, or in which the Company or its subsidiaries have participated with respect to their product candidates, that are described in the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, being conducted in all material respects in accordance with the protocols submitted to respects, and all applicable laws, rules, regulations and policies enforced by the FDA and or any comparable foreign regulatory authorityGovernmental Authority, or by any institutional review board, ethics review board or committee, in each case having authority or responsible for the oversight of such studies and trials (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate in all material respects; the Company has or its subsidiaries have no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question in question any material respect the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company has not nor its subsidiaries have received any written notices notice, correspondence or correspondence with the FDA other communications from any Regulatory Authority requiring or any foreign, state or local governmental body exercising comparable authority, requiring threatening (A) the termination, suspension or clinical hold of any preclinical studies or clinical trials being conducted by or on behalf of, or sponsored by, the Company or its subsidiaries or in which the Company or its subsidiaries are participating, or (B) the material adverse modification of any Company Studies preclinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the General Disclosure Package or material modification would reasonably be expected the Prospectus, other than ordinary course communications with respect to have a Material Adverse Effect modifications in connection with the design and implementation of such studies or trials, 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 Except as disclosed in the General Disclosure Package and the Final Prospectus, (i) the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package and the Prospectus (Final Prospectus, or the “Company Studies results of which are referred to in the General Disclosure Package and Trials”) were andthe Final Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject (collectively, the FDA “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practices and Good Laboratory Practices, as applicable; (ii) the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and the Final Prospectus of the results of such studies and trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Final Prospectus; and (iv) the Company has not 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 Regulatory Authorities; and (v) neither the Company nor its subsidiaries have received any written notices or correspondence with communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, suspension or material modification or suspension of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the General Disclosure Package and the Final Prospectus or the results of which are referred to in the General Disclosure Package and the Final Prospectus, suspension other than ordinary course written communications with respect to modifications in connection with the design and implementation of such studies or material modification would reasonably be expected to have a Material Adverse Effect trials, 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 or and clinical trials conducted by or 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 the General Disclosure Package SEC Reports or the results of which are referred to in the SEC Reports, as applicable, were, and if still pending are, being conducted in accordance with the Prospectus 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 rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which they are subject (such institutional review boards, ethics review boards, committees, the FDA or any comparable regulatory agencies, collectively, the “Company Studies and TrialsRegulatory Authorities”) were and, if still pending, and any and all applicable Health Care Laws; the descriptions in the SEC Reports of the results of such studies and trials are being, conducted accurate and complete in all material respects in accordance with and fairly present the protocols submitted to data derived from such studies and trials and known at the FDA and any comparable foreign regulatory authority; the descriptions time of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respectsdisclosure; the Company has no knowledge of any other preclinical studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectusclinical trials, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package and the ProspectusSEC Reports; and neither the Company has not nor its Subsidiaries have received any written notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other Governmental Authority requiring or local governmental body exercising comparable authority, requiring threatening (i) the termination, 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 SEC Reports, or (ii) the material modification of any Company Studies preclinical studies or Trials clinical trials that terminationwould cause them to materially differ from their descriptions in the SEC Reports, suspension other than ordinary course communications with respect to modifications in connection with the design and implementation of such preclinical studies or material modification would reasonably be expected to have a Material Adverse Effect andclinical trials, and to the Company’s knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused is taking all reasonable steps necessary to ensure that its clinical trials will be obtained) informed consent conducted in accordance with 16 any conditions of approval and policies imposed 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 Regulatory Authorities for such 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 subjecttrials.

Preclinical Studies and Clinical Trials. The (i) Except as described in the SEC Reports, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package SEC Reports, or the results of which are referred to in the SEC Reports, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA and any comparable foreign regulatory authoritythe EMA (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Reports of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the SEC Reports; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the ProspectusSEC Reports; and (iv) the Company has not received any written notices or correspondence with the FDA or any foreignand its subsidiaries have, state or local governmental body exercising comparable authoritysince January 1, requiring the termination2020, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there operated and 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 currently in compliance in all material respects with all applicable statutes, rules, rules and regulations of the FDA Regulatory Authorities, except that where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and comparable regulatory agencies outside of the United States to which (v) neither the Company is subjectnor any of its subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the SEC Reports or the results of which are referred to in the SEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials.

Preclinical Studies and Clinical Trials. The preclinical studies or and clinical trials conducted by or by, on behalf of or sponsored by the Company or any of its subsidiaries, or in which the Company or any such subsidiary has participated, that are described in, or the results of which are referred to in, the Registration Statement and the Prospectus, or the results of which are referred to in the General Disclosure Package Registration Statement and the Prospectus 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 (collectively, the “Company Studies and TrialsRegulatory Authorities”) were andexcept where the failure to be so in compliance has not resulted and would not reasonably be expected to, if still pendingsingly or in the aggregate, result in a Material Adverse Effect; the descriptions in the Registration Statement or the Prospectus of the results of such studies and trials are being, conducted accurate and not misleading in all material respects in accordance with the protocols submitted respect to the FDA portions of such studies and any comparable foreign regulatory authoritytrials being described and fairly present the data derived from such studies or trials; the descriptions of the results of neither the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; 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 has not received any written notices notice, correspondence or correspondence with other communications from the FDA Regulatory Authorities requiring or threatening (i) the termination or suspension of any foreignpreclinical studies and clinical trials that are described in, state or local governmental body exercising comparable authoritythe results of which are referred to in, requiring the termination, suspension Registration Statement and the Prospectus or (ii) the material modification of any Company Studies preclinical studies and clinical trials that would cause them to differ from their descriptions in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to 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 (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA U.S. Food and any comparable foreign regulatory authorityDrug Administration and the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the Registration Statement; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in into question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; (v) the Company has provided Guggenheim Securities with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiary, or in which the Company or its subsidiary has participated, that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the FDA European Medicines Agency (collectively, the “Regulatory Authorities”) and any comparable foreign regulatory authorityGood Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has not received any written notices 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 correspondence with in the FDA or any foreignaggregate, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect; and (v) neither the Company nor its subsidiary, to the Company’s knowledge, has received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, 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 (i) Except as described in the SEC Reports, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package SEC Reports, or the results of which are referred to in the SEC Reports, as applicable, were, and the Prospectus (the “Company Studies and Trials”) were and, if still pendingpending are, are being, being conducted in all material respects in accordance with all applicable statutes and all applicable rules and regulations of the protocols submitted applicable regulatory agencies to which they are subject, including the FDA and any comparable foreign regulatory authoritythe European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the SEC Reports of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate descriptions in all material respectsrespects and fairly present the data derived therefrom as of the dates given for such data in the SEC Reports; (iii) the Company has no knowledge of any other studies or 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 are inconsistent with or call in question raise substantial doubt regarding the results described or referred to in the General Disclosure Package and the ProspectusSEC Reports; and (iv) the Company has not received any written notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to and its subsidiaries have a Material Adverse Effect and, to the Company’s knowledge, there operated at all times and 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 currently in compliance in all material respects with all applicable statutes, rules, rules and regulations of the FDA Regulatory Authorities, except that where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and comparable regulatory agencies outside of the United States to which (v) neither the Company is subjectnor any of its subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical studies or clinical trials that are described in the SEC Reports or the results of which are referred to in the SEC Reports, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials.

Preclinical Studies and Clinical Trials. The (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies or and clinical trials conducted by or 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 have participated, that are described in the General Disclosure Package Registration Statement and the Prospectus (Prospectus, or the “Company Studies results of which are referred to in the Registration Statement and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, being conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”), and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA and any comparable foreign regulatory authorityEMA) (collectively, the “Regulatory Authorities”), the applicable rules and regulations of the Regulatory Authorities, and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate in all material respectsand fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package Registration Statement and the 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 Regulatory Authorities; (v) the Company has not provided the Agent with all material written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, suspension or material modification or suspension of any Company Studies preclinical studies or Trials clinical trials that terminationare described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, suspension other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or material modification would reasonably be expected to have a Material Adverse Effect trials, 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 or and clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiary, or in which the Company or its subsidiary have participated that are described in the General Registration Statement, the Pricing Disclosure Package and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Pricing Disclosure Package and Trials”) were andthe Prospectus, as applicable, were, and if still pendingpending are, are being, 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 protocols submitted to Company and all applicable statutes and all applicable rules and regulations of the FDA Regulatory Authorities and any comparable foreign regulatory authoritycurrent Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies such studies and Trials contained in the General Disclosure Package and Prospectus trials are accurate and complete in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Pricing Disclosure Package and the Prospectus, Prospectus the results of which are inconsistent with or call in into question the results described or referred to in the General Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iv) the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; (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 subsidiary have not received any written notices notices, correspondence or correspondence with other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority, requiring threatening the termination, modification or suspension or material modification of any Company Studies pre-clinical studies or Trials clinical trials that terminationare described in the Registration Statement, suspension the Pricing Disclosure Package and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Pricing Disclosure Package and the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or 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 the Company Studies and Trialsa company trial. In using or disclosing patient information received by the Company or its subsidiary in connection with the Company Studies and Trialsa company trial, 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”) HIPAA and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials Company’s trials involved any investigator who has been disqualified as a clinical investigator or debarred has been found by the FDA. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated FDA or any other Applicable Regulatory Authority to have engaged 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 subjectscientific misconduct.