Common use of Trials Clause in Contracts

Trials. The clinical, pre-clinical and other trials, studies and tests conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the General Disclosure Package and the Prospectuses or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectuses were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package and the Prospectuses of the preliminary or interim results of such studies and tests received by the Company to date are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectuses, the Company has no knowledge of any other trials, studies or tests the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectuses; the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; and the Company has not received any notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical or pre-clinical trials, studies or tests that are described in the Registration Statement, the General Disclosure Package and the Prospectuses or the results of which are referred to in the Registration Statement, General Disclosure Package and the Prospectuses and, to the Company’s knowledge, there is no reasonable basis for the same.

Trials. The clinical(i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the pre-clinical and other trials, studies and tests clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, Company or its subsidiaries or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the General Pricing Disclosure Package and the Prospectuses Prospectus, or the results of which are referred to in the Registration Statement, the General Pricing Disclosure Package and the Prospectuses were andProspectus, as applicable, were, and if still pendingpending are, 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, rules, statutes and all applicable rules and regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which it is subject they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, ) and 312, and current Good Clinical Practices and Good Laboratory Practices, except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; (ii) the descriptions in the Registration Statement, the General Pricing Disclosure Package and the Prospectuses Prospectus of the preliminary or interim results of such studies and tests received by the Company to date trials are accurate and complete descriptions in all material respects and fairly present the data derived from such trials, studies and tests, and except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectuses, therefrom; (iii) the Company has no knowledge of any other trials, studies or tests trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the General Pricing Disclosure Package and the ProspectusesProspectus; and (iv) except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies nor any of the Regulatory Authorities; and the Company has not its subsidiaries have received any written notices, correspondence or other communication communications from the Regulatory Authorities or any other governmental agency which could lead to requiring or threatening the termination termination, material modification or suspension of any clinical or pre-clinical trials, studies or tests clinical trials that are described in the Registration Statement, the General Pricing Disclosure Package and the Prospectuses Prospectus or the results of which are referred to in the Registration Statement, General the Pricing Disclosure Package and the Prospectuses 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 best knowledge, there is are no reasonable basis grounds for the same.

Trials. The clinical, pre-clinical and other trials, studies and tests conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the General Disclosure Package Time of Sale Information and the Prospectuses Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package Time of Sale Information and the Prospectuses Prospectus were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package Time of Sale Information and the Prospectuses Prospectus of the preliminary or interim results of such studies and tests received by the Company to date are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectuses, the Company has no knowledge of any other trials, studies or tests the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the General Disclosure Package Time of Sale Information and the ProspectusesProspectus; the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; and the Company has not received any notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical or pre-clinical trials, studies or tests that are described in the Registration Statement, the General Disclosure Package Time of Sale Information and the Prospectuses Prospectus or the results of which are referred to in the Registration Statement, General Disclosure Package Time or Sale Information and the Prospectuses Prospectus and, to the Company’s knowledge, there is no reasonable basis for the same.

Trials. The clinical, pre-clinical and other trials, studies and tests conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the General Disclosure Package and the Prospectuses or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectuses were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules, regulations and policies of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package and the Prospectuses of the preliminary or interim results of such studies and tests received by the Company to date are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectuses, the Company has no knowledge of any other trials, studies or tests the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectuses; the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; and the Company has not received any notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical or pre-clinical trials, studies or tests that are described in the Registration Statement, the General Disclosure Package and the Prospectuses or the results of which are referred to in the Registration Statement, General Disclosure Package and the Prospectuses and, to the Company’s knowledge, there is no reasonable basis for the same.