Clinical Matters. The preclinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of the Company, since January 1, 2016 have been and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Health Care Laws and applicable Governmental Licenses; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such preclinical studies and clinical trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any preclinical studies or clinical trials, the results of which the Company believes reasonably call into question the preclinical study or clinical trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described; and neither the Company nor any of the subsidiaries has received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any preclinical study or clinical trial conducted by or on behalf of the Company.
Clinical Matters. The preclinical and clinical studies and tests described in the Registration Statement, the Time of Sale Prospectus and the Prospectus conducted by or, to the knowledge of the Company, on behalf of the Company, have been and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Health Care Laws and applicable Governmental Licenses; the descriptions of the results of such preclinical and clinical studies and tests contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such preclinical and clinical studies and tests; except to the extent disclosed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company is not aware of any preclinical or clinical studies or tests, the results of which the Company believes reasonably call into question the preclinical or clinical study or test 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; and neither the Company nor any of the Subsidiaries has received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any preclinical or clinical study or test conducted by or on behalf of the Company.
Clinical Matters a) any scientific and medical matters
Clinical Matters. (i) Each Investigational New Drug application (“IND”) submitted by the Company or any of its subsidiaries to the FDA or equivalent application submitted by the Company to foreign regulatory bodies, and related documents and written information, has been submitted and maintained in compliance in all material respects with applicable statutes, rules and regulations administered or promulgated by the FDA or other regulatory body (“FDA Laws”), or was corrected or supplemented by a subsequent document or written information in compliance in all material respects with FDA Laws, except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; (ii) to the Company’s knowledge, the studies, tests and preclinical and clinical trials conducted by or on behalf of the Company or its subsidiaries that are described in the General Disclosure Package or the Prospectus 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 medical and scientific standards; and the drug substances used in the clinical trials have been manufactured in all material respects under applicable current Good Manufacturing Practice requirements, except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; and (iii) the descriptions of the results of the studies, tests and preclinical and clinical trials that are described in the General Disclosure Package and the Prospectus are accurate and complete in all material respects. Neither the Company nor any of its subsidiaries has received any written notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries. To the Company’s knowledge, no filing or submission made by the Company to the FDA or any other regulatory body, that is intended to be the basis for any approval of the Company’s or any of its subsidiaries’ product candidates, contained any material omission or, materially false information as of the date of submission, and any necessary or required updates, changes, corrections or modifications have been submitted to the relevant regulatory body.
Clinical Matters. Any dispute in connection with a Nominated Medical Practitioner’s Clinical Privileges or clinical conduct cannot be dealt with under this Clause 9, but will be subject to and dealt with in accordance with the procedures in respect to clinical privileges, conduct and governance referred to in the MOU.
Clinical Matters. After the Funding Date of the Third Tranche Term Loan, Borrowers shall maintain two distinct programs in Borrower sponsored active human clinical trials under a Borrower owned IND at all times (excluding the CD73 Program).
Clinical Matters. The preclinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of the Company, since January 1, 2016 have been and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to all Health Care Laws and applicable Governmental Licenses; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly present the data derived from such preclinical studies and clinical trials; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is not aware of any preclinical studies or clinical trials, the results of which the Company believes reasonably call into question the preclinical study or clinical trial results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and neither the Company nor any of the subsidiaries has received any written notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any preclinical study or clinical trial conducted by or on behalf of the Company.
Clinical Matters. (i) The studies, tests and preclinical and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package or the Prospectus 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 medical and scientific standards; and the drug substances used in the clinical trials have been manufactured in all material respects under applicable current Good Manufacturing Practice requirements, except as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Change; and (ii) the descriptions of the results of the studies, tests and preclinical and clinical trials that are described in the General Disclosure Package and the Prospectus are accurate and complete in all material respects. The Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company.
Clinical Matters. It is acknowledged by the parties that Cyberonics shall have primary responsibility and decision-making powers regarding any clinical matters relating to the “Products” including, but not limited to, the drafting of any study protocols involving the “Products.”
Clinical Matters. Notwithstanding the parties’ general and specific rights and responsibilities set forth in this Agreement, neither NTN nor American Well shall be required to, and shall not engage in any activity which constitutes the practice of medicine. Neither party shall direct, control, attempt to control, influence, restrict or interfere with PC’s or any of its qualified professionals’ exercise of independent clinical, medical or professional judgment in providing healthcare or medical-related services. PC shall have and retain full authority and control with respect to all medical and ethical professional determinations and shall be solely responsible for the provision of clinical services, including the approval of all practice guidelines.
