Common use of Clinical Trials Clause in Contracts

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of 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 Time of Sale Prospectus or the Prospectus of the results of such studies and trials are accurate and complete and fairly present the data derived from such trials; the Company has no knowledge of any other trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of its Subsidiaries, has not received any written notices, correspondence or other communication from the Regulatory Authorities or any governmental authority which could lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Prospectus or the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus, and there are no reasonable grounds for same.

Appears in 3 contracts

Samples: Underwriting Agreement (Aptose Biosciences Inc.), Underwriting Agreement (Aptose Biosciences Inc.), Underwriting Agreement (Aptose Biosciences Inc.)

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Clinical Trials. The clinical and pre-clinical studies 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 Registration Statementin, the Time of Sale Prospectus and the Prospectus or the results of which are referred to in in, the Registration Statement, the Time of Sale General Disclosure Package, the Prospectus and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, or any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, all applicable statutes, and all rules and regulations of the FDA United States Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which it is they are subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Time of Sale Prospectus applicable to pre-clinical or the Prospectus clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description of the results of such studies and trials are contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is accurate and complete in all material respects, and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials the results of which are inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement, the Time of Sale General Disclosure Package, the Prospectus and the Prospectus; the or any Written Testing-the-Waters Communication. The Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of its Subsidiaries, has not received any written notices, correspondence or other communication communications from the Regulatory Authorities FDA or any governmental authority which could lead to committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the termination “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Prospectus or the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Prospectus, and there are no reasonable grounds for sameRegulatory Agencies.

Appears in 3 contracts

Samples: Underwriting Agreement (Benitec Biopharma LTD/ADR), Underwriting Agreement (Benitec Biopharma LTD/ADR), Underwriting Agreement (Benitec Biopharma LTD/ADR)

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf of or sponsored by the CompanyCompany or its subsidiaries, or (y) in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Prospectus, and the Time of Sale Prospectus and the Prospectus Information, or the results of which are referred to in the Registration Statement, the Prospectus, and the Time of Sale Prospectus and the ProspectusInformation, as applicable, were, and are intended to be submitted to Regulatory Authorities as a basis for product approval, 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 or its subsidiaries and all applicable statutes, statutes and all rules and regulations of the FDA and other comparable drug regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which it is they are subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, ) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Prospectus or the Prospectus Information of the results of such studies and trials tests are accurate and complete descriptions in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trials trials, the results of which the Company believes are inconsistent with or otherwise reasonably call into question the results described or referred to in the Registration Statement, the Prospectus or the Time of Sale Prospectus and the ProspectusInformation; the Company and its Subsidiaries subsidiaries have each operated at all times and are is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of Company and its Subsidiaries, has subsidiaries have not received any written notices, correspondence or other communication communications from the Regulatory Authorities or any other governmental authority which could lead to agency requiring or threatening the termination termination, modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Prospectus or the Prospectus Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Prospectus or Information, and, to the ProspectusCompany’s knowledge, and there are no reasonable grounds for the same.

Appears in 2 contracts

Samples: Sales Agreement (Kala Pharmaceuticals, Inc.), Sales Agreement (Kala Pharmaceuticals, Inc.)

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities regulatory authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures their protocols and all applicable statutes, rules and regulations of the FDA United States 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 Time of Sale Prospectus Statement or the Prospectus of the results of such studies clinical and preclinical trials are accurate and complete in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement and the Prospectus; the Company and its Subsidiaries subsidiaries have each operated and are currently in compliance in all material respects with all applicable statutes, rules and regulations Applicable Laws of the Regulatory Authorities; neither the Company, Company nor any of its Subsidiaries, has not subsidiaries have received any written notices, correspondence or other written communication from the Regulatory Authorities or any other governmental authority agency which could lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus, and and, to the Company’s knowledge, there are no reasonable grounds for same.

Appears in 2 contracts

Samples: Sales Agreement (Dermira, Inc.), Sales Agreement (Dermira, Inc.)

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf of or sponsored by the CompanyCompany or its subsidiaries, or (y) in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Prospectus, and the Time of Sale Prospectus and the Prospectus Information, or the results of which are referred to in the Registration Statement, the Prospectus, and the Time of Sale Prospectus and the ProspectusInformation, as applicable, were, and are intended to be submitted to Regulatory Authorities as a basis for product approval, 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 or its subsidiaries and all applicable statutes, statutes and all rules and regulations of the FDA and other comparable drug regulatory agencies outside of authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the United States FDA) to which it is they are subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, ) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Prospectus or the Prospectus Information of the results of such studies and trials tests are accurate and complete descriptions in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trials trials, the results of which the Company believes are inconsistent with or otherwise reasonably call into question the results described or referred to in the Registration Statement, the Prospectus or the Time of Sale Prospectus and the ProspectusInformation; the Company and its Subsidiaries subsidiaries have each operated at all times and are is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of Company and its Subsidiaries, has subsidiaries have not received any written notices, correspondence or other communication communications from the Regulatory Authorities or any other governmental authority which could lead to agency requiring or threatening the termination termination, modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Prospectus and the Time of Sale Prospectus or the Prospectus Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Prospectus or Information, and, to the ProspectusCompany’s knowledge, and there are no reasonable grounds for the same.. ​ ​

Appears in 1 contract

Samples: Kala Pharmaceuticals, Inc.

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Clinical Trials. The clinical and pre-material human clinical trials conducted by or on behalf of or sponsored by the Company, Company or in which the Company has participated, participated relating to ranolazine and regadenoson and that are described in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus, as applicableif any, are the only material human clinical trials currently being conducted by or on behalf of the Company, and, to the best of the Company’s knowledge, such studies and are intended to be submitted to Regulatory Authorities as a basis for product approval, tests were and, if still pending, are being being, conducted in accordance with standard medical and scientific research experimental protocols, procedures and all applicable statutes, rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States controls pursuant 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 Practicesaccepted professional scientific standards; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Prospectus or General Disclosure Package and the Prospectus of the results of such studies and trials Prospectus, if any, are accurate and complete and fairly present the data derived from such trials; the in all material respects. 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 of the clinical trials described or referred to in the Registration Statement, the Time of Sale Prospectus General Disclosure Package and the Prospectus; the . The Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of its Subsidiaries, has not received any written notices, notices or correspondence or other communication from the Regulatory Authorities FDA or any other governmental authority which could lead to agency requiring the termination termination, suspension or suspension modification of any clinical trials conducted by, or pre-clinical trials on behalf of, the Company or in which the Company has participated that are described in the Registration Statement, the Time of Sale Prospectus or General Disclosure Package and the Prospectus Prospectus, if any, or the results of which are referred to in the Registration Statement, the Time General Disclosure Package and the Prospectus. All human clinical trials previously conducted by or on behalf of Sale Prospectus the Company while conducted by or on behalf of the Company, were conducted in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus, if any, are accurate and there are no reasonable grounds for same.complete in all material respects

Appears in 1 contract

Samples: Purchase Agreement (Cv Therapeutics Inc)

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

Appears in 1 contract

Samples: Underwriting Agreement (Cynapsus Therapeutics Inc.)

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