Common use of Clinical Trials Clause in Contracts

Clinical Trials. The pre-clinical studies and clinical trials conducted by 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, or the results of which are referred to in, the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with 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 United States Food and Drug Administration (the “FDA”) and comparable regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or 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 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 the Company has no knowledge of any other studies or trials 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, the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the 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 Regulatory Agencies.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company, or in which the Company has participated, that are described inin the Registration Statement, the Time of Sale Prospectus and the Prospectus or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageTime of Sale Prospectus and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication 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 all material respects in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, standard medical and scientific research procedures and all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) FDA and comparable drug regulatory agencies outside of the United States to which they are it is subject applicable to pre-clinical (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 clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description the Prospectus of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is 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 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 General Disclosure PackageTime 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 Prospectus or Regulatory Authorities; neither the Company, nor any Written Testing-the-Waters Communication. The Company of its Subsidiaries, has not received any written notices, correspondence or other communications communication from the FDA Regulatory Authorities or any committee thereof governmental authority which could lead to the termination or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “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 General Disclosure Package, the Time of Sale Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times the Prospectus, and currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Agenciesthere are no reasonable grounds for same.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, 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, in the Registration Statement and the Prospectus or the results of which are referred to in, in the Registration StatementStatement and the Prospectus, the General Disclosure Packageas applicable, the Prospectus or any Written Testing-the-Waters Communication and are intended to be submitted to regulatory authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with their protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, and all applicable statutes, and all rules and regulations of the United States Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which they are it is subject applicable to pre-clinical (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 or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description the Prospectus of the results of such studies clinical and preclinical trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is are accurate and complete in all material respects, 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, Statement and the General Disclosure Package, Prospectus; the Prospectus or any Written Testing-the-Waters Communication. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that and its subsidiaries have operated and are described or referred to in the Registration Statement, the 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 Applicable Laws of the Regulatory AgenciesAuthorities; neither the Company nor its subsidiaries have received any written notices, correspondence or other written 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 that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for same.

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of 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 inin the Registration Statement, the Prospectus, and the Time of Sale Information, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageProspectus, and the Prospectus or any Written Testing-the-Waters Communication were andTime of Sale Information, as applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study Company or trial, as the case may be, its subsidiaries and all applicable statutes, statutes and all rules and regulations of the United States Food FDA and Drug Administration (the “FDA”) and other comparable 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 they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Information of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is tests are accurate and complete descriptions in all material respects, respects and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials trials, the results of which the Company believes are inconsistent with, with or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The the Time of Sale Information; the Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has and its subsidiaries have operated at all times and is currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory AgenciesAuthorities; the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the 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 Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, and, to the Company’s knowledge, there are no reasonable grounds for the same.

Clinical Trials. The clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, or on behalf of or sponsored by the Company, or in which the Company has participated, that are described inin the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication were andas applicable, were, and if still pendingpending are, are being conducted conducted, in all material respects respects, in accordance with protocols filed with the appropriate regulatory authorities for each such study or trial, as the case may be, standard medical and scientific research standards and procedures and all applicable statutes, statutes and all rules and regulations of the United States U.S. Food and Drug Administration (the “FDA”) and comparable 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 they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description of FDA) (collectively, the results of such studies “Regulatory Authorities”) and trials contained current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package, Package and the Prospectus or any Written Testing-the-Waters Communication is of the results of such studies and tests 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 studies or trials 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 General Disclosure PackagePackage or the Prospectus; 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 Prospectus or any Written Testing-the-Waters Communication. The Regulatory Authorities; the Company has not received any written notices, correspondence or other communications from the FDA Regulatory Authorities or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory governmental agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, modification or suspension or modification of any clinical or pre-clinical trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, and, to 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 statutesCompany’s knowledge, rules, regulations and policies of there are no reasonable grounds for the Regulatory Agenciessame.

Clinical Trials. The pre-clinical studies and material human clinical trials conducted by or, to the knowledge of the Company, 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 inin the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, if any, are the Prospectus only material human clinical trials currently being conducted by or any Written Testing-the-Waters Communication on behalf of the Company, and, to the best of the Company’s knowledge, such studies and tests were and, if still pending, are being being, conducted in all material respects in accordance with protocols filed with experimental protocols, procedures and controls pursuant to accepted professional scientific standards; 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 United States Food and Drug Administration (the “FDA”) and comparable regulatory agencies outside of the United States to which they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description descriptions of the results of such studies studies, tests and trials contained in the Registration Statement, the General Disclosure PackagePackage and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication is if any, are accurate and complete in all material respects, and the . The Company has no knowledge of any other studies or tests, the results of which call into question the results of the clinical trials described in the Registration Statement, the General Disclosure Package and the Prospectus. The Company has not received any notices or correspondence from the FDA or any other governmental agency requiring the termination, suspension or modification of any clinical trials conducted by, or on behalf of, the Company or in which the Company has participated that are described in the Registration Statement, the General Disclosure Package and the Prospectus, if any, or 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, Package and the Prospectus or any Written Testing-the-Waters CommunicationProspectus. The Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any All human clinical trials that are described previously conducted by or referred on behalf of 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 PackagePackage and the Prospectus, the Prospectus or any Written Testing-the-Waters Communication. The Company has operated at all times if any, are accurate and currently is in compliance complete in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Agencies.respects

Clinical Trials. The Except as described in the Registration Statement, the Prospectus, and the Time of Sale Information, the clinical and pre-clinical studies and clinical trials conducted by or, to the knowledge of 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 inin the Registration Statement, the Prospectus, and the Time of Sale Information, or the results of which are referred to in, in the Registration Statement, the General Disclosure PackageProspectus, and the Prospectus or any Written Testing-the-Waters Communication were andTime of Sale Information, as applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols filed with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the appropriate regulatory authorities for each such study Company or trial, as the case may be, its subsidiaries and all applicable statutes, statutes and all rules and regulations of the United States Food FDA and Drug Administration (the “FDA”) and other comparable 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 they are subject applicable to pre-clinical or clinical studies from which data will be submitted to support further pre-clinical or clinical trials or marketing approval. Each description (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Prospectus, and the Time of Sale Information of the results of such studies and trials contained in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication is tests are accurate and complete descriptions in all material respects, respects and fairly present the data derived from such trials; the Company has no knowledge of any other studies or trials trials, the results of which the Company believes are inconsistent with, with or otherwise reasonably call into question, question the results described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The the Time of Sale Information; the Company has not received any notices, correspondence or other communications from the FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company has and its subsidiaries have operated at all times and is currently is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the Regulatory Agencies.Authorities; the Company and its subsidiaries have not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the 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 Information or the results of which are referred to in the Registration Statement, the Prospectus and the Time of Sale Information, and, to the Company’s knowledge, there are no reasonable grounds for the same. ​ ​