Common use of Preclinical and Clinical Studies Clause in Contracts

Preclinical and Clinical Studies. The studies, tests and preclinical 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 with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controls; 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 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. 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical and Clinical Studies. The studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and the Prospectus, the preclinical or and clinical trials studies 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 results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the 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 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 “Company Studies results of such studies are accurate and Trials”) were and, if still pending, are being, conducted complete descriptions in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controlsfairly present the data derived therefrom; the descriptions of the results of (iii) the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge does not have any 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 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 operated at all times and are no reasonable grounds for the same. 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated currently in compliance in all material respects with all applicable statutes, rules and regulations of the FDA Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and comparable regulatory agencies outside (v) the Company, to the Company’s knowledge, has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies that are described in the United States Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to which in the Company is subjectRegistration 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, and to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical and Clinical Studies. The studies(i) Except as described in the Registration Statement and the Prospectus, tests the preclinical and preclinical or clinical trials studies 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 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 with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocolsstandard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations of the U.S. Food and Drug Administration, procedures any U.S. state departments of health and controlsboards of pharmacy, and comparable regulatory agencies outside of the United States to which they are subject, including 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 and Trials contained in the General Disclosure Package and Prospectus such studies are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; (iii) the Company has no Knowledge does not have 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 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 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 operated at all times and are no reasonable grounds for the same. 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated currently in compliance in all material respects with all applicable statutes, rules and regulations of the FDA Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and comparable regulatory agencies outside (v) the Company, to the Company’s knowledge, has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies that are described in the United States Registration Statement and the Prospectus or the results of which are referred to which in the Company is subjectRegistration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies, and to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical and Clinical Studies. The studies(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and the Prospectus, the preclinical or and clinical trials studies 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 results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the 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 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 “Company Studies results of such studies are accurate and Trials”) were and, if still pending, are being, conducted complete descriptions in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controlsfairly present the data derived therefrom; the descriptions of the results of (iii) the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge does not have any 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 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 operated at all times and are no reasonable grounds for the same. 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated currently in compliance in all material respects with all applicable statutes, rules and regulations of the FDA Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; and comparable regulatory agencies outside (v) the Company, to the Company’s knowledge, has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any preclinical or clinical studies that are described in the United States Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to which in the Company is subjectRegistration 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, and to the Company’s knowledge, there are no reasonable grounds for the same.

Preclinical and Clinical Studies. The studies, tests and preclinical 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 with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controlscontrols pursuant to, where applicable, accepted professional scientific standards; 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 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 from 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 Knowledgeknowledge, there are no reasonable grounds for the same. In To the extent applicable, in using or disclosing patient information received by the Company in connection with the Company Studies and Trials, during the past six (6) years, the Company has and its subsidiaries have 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 1996, as amended (“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 has been found by the FDA to have engaged in scientific misconductor comparable foreign, state, or local regulatory authority during the past six (6) years. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical and Clinical Studies. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company 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 with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controls; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package Registration Statement and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement, 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 Registration Statement and the Prospectus; and the Company has not received any 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. 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 has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical and Clinical Studies. The studies, tests and preclinical 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 with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controlscontrols pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package Registration Statement and the Prospectus are accurate in all material respects; the Company has and its subsidiaries have no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and Statement or the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package Registration Statement and the Prospectus; and the Company has not received any 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 and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, 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 has been found debarred by the FDA to have engaged in scientific misconductFDA. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Preclinical and Clinical Studies. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package Time of Sale Prospectus and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controlscontrols pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package Time of Sale Prospectus and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package Time of Sale Prospectus and the Prospectus; and the Company has not received any 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 Knowledgeknowledge, 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 has been found debarred by the FDA to have engaged in scientific misconductFDA. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.