Studies and Trials Sample Clauses
The "Studies and Trials" clause defines the rules and requirements for conducting research, clinical studies, or trials under the agreement. It typically outlines the responsibilities of the parties regarding the design, approval, conduct, and reporting of such studies, and may specify standards for data collection, ethical compliance, and regulatory approvals. This clause ensures that all research activities are carried out in a controlled and compliant manner, minimizing legal and ethical risks while clarifying expectations for both parties.
Studies and Trials. The animal and other preclinical and nonclinical studies and the clinical trials for Epidiolex, Sativex and all of the Company’s product candidates as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, conducted by the Company or any subsidiary or on behalf of the Company or any subsidiary, or, to the Company’s knowledge, by any individual physician under a treatment investigational new drug application, were, and if still pending are, being conducted in all material respects in compliance with all Applicable Laws and in accordance with their protocols, procedures and controls; the descriptions of the results of such preclinical and other nonclinical studies and clinical trials contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus are accurate in all material respects, and, except as set forth in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company has no knowledge of any other clinical trials or nonclinical studies, the results of which reasonably call into question the clinical trial or nonclinical study results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described, except as would not reasonably be expected to result in a material adverse effect on the Company and its subsidiaries, taken as a whole; and the Company has not received any written notices or correspondence or other communications from the FDA, the DEA, the EMA, the MHRA or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company or any subsidiary 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, which termination, suspension or modification would reasonably be expected to result in a material adverse effect on the Company and its subsidiaries, taken as a whole.
Studies and Trials. All studies and trials conducted by or on behalf of the Company and its Subsidiaries on all products, compounds or study drugs of the Company or its Subsidiaries have been made available to Parent, and the Company has otherwise provided for review all material preclinical and clinical studies and trials regarding the efficacy and safety of all products, compounds or study drugs of the Company or its Subsidiaries. The Company has heretofore made available to Parent all material written correspondence between the Company and its Subsidiaries with the FDA and any other applicable Governmental Body regarding any products, compounds or study drugs of the Company or its Subsidiaries.
Studies and Trials. The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any studies or trials not described in the Prospectus, the results of which are inconsistent with or call into question any results described or referred to in the Prospectus; and the Company has not received any notices or correspondence 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 and Trials where such termination, suspension or material modification could 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 HIPAA (as defined below) and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved or, if still pending, involve any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. All studies, tests and preclinical or clinical trials other than the Company Studies and Trials that are described in the Prospectus (the “Other Studies and Trials”), to the Company’s Knowledge, were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the descriptions of the results of the Other Studies and Trials contained in the Prospectus are accurate in all material respects. To the Company’s Knowledge, the manufac...
Studies and Trials. (i) The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of or sponsored by the Company or in which the Company has participated, were, and if still pending are being conducted in all material respects in accordance with standard medical and experimental protocols, procedures and controls pursuant to accepted professional scientific research standards and procedures, and all applicable Health Care Laws, the rules and regulations of the Regulatory Authorities and, to the extent required, current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions of the results of such studies and trials contained in the Registration Statement or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such trials and studies; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; has provided ▇▇ ▇▇▇▇▇ with all substantive written notices, correspondence and summaries of all other communications provided to the Company from the Regulatory Authorities; and (iv) the Company has not received any written notices or correspondence from any Regulatory Authority or any other governmental entity requiring the termination, material modification or suspension of any studies or 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.
Studies and Trials. All studies and trials conducted by or on behalf of Parent and its Subsidiaries on all products, compounds or study drugs of Parent or its Subsidiaries have been made available to the Company, and Parent has otherwise provided for review all material preclinical and clinical studies and trials regarding the efficacy and safety of all products, compounds or study drugs of Parent or its Subsidiaries. Parent has heretofore made available to the Company all material written correspondence between Parent and its Subsidiaries with the FDA and any other applicable Governmental Body regarding any products, compounds or study drugs of Parent or its Subsidiaries.