Preclinical and Clinical Studies and Tests. The preclinical and clinical studies and tests conducted by, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with the experimental protocols established for each study or trial, as well as any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical and clinical studies and tests, and all applicable local, state and federal laws, rules and regulations of the FDA, the EMA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”) except where the failure to be so in compliance has not resulted and would not reasonably be expected to, singly or in the aggregate, result in a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and tests are accurate and not misleading in all material respects with respect to the portions of such studies being described and fairly present the data derived from such studies or tests; the Company has no knowledge of any other studies or tests not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the 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 the current state of development; neither the Company nor its subsidiaries have received any written notice, correspondence or other communications from the Regulatory Authorities requiring or threatening (i) the termination or suspension of any preclinical and clinical studies or tests that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, or (ii) the material modification of any preclinical and clinical studies or tests that would cause them to differ from their descriptions in the Registration Statement, the General Disclosure Package and the Prospectus, other than ordinary ...
Preclinical and Clinical Studies and Tests. The preclinical tests and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, were and, if still pending, are being conducted in all material respects in accordance with protocols filed with the appropriate Regulatory Agencies for each such test or trial, as the case may be, and with standard medical and scientific research procedures and all applicable statutes, directives, rules and regulations of the Regulatory Agencies, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder; each description of such tests and trials, and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus, as applicable, is accurate and complete in all material respects and fairly presents the data about and derived from such tests and trials, and the Company has no knowledge of any other studies or tests or modifications, 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 Prospectus, as applicable; neither the Company nor its subsidiaries has received any notices or other correspondence from any Regulatory Agency requiring the termination, suspension or modification of any clinical trials; and each of the Company and its subsidiaries has operated and currently is in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies.
Preclinical and Clinical Studies and Tests. (i) The preclinical studies, clinical studies, and clinical trials conducted by or on behalf of or sponsored by the Company and its subsidiaries (“Studies”) were and, if still ongoing, are being conducted in all material respects in accordance with Applicable Laws, Authorizations, and Health Care Laws, as applicable, including 21 C.F.R. Parts 11 and 58; (ii) the Company and its subsidiaries and, to the knowledge of the Company, its agents, are not aware of any Studies not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are materially inconsistent with or materially call into question the results of Studies described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and (iii) the Company and its subsidiaries and, to the knowledge of the Company, its agents, have not received any written notices, correspondence or other communications from the FDA, HHS or any governmental or regulatory authority requiring or threatening the termination, suspension or material modification of any Studies.
Preclinical and Clinical Studies and Tests. The preclinical and clinical studies and tests (collectively, “Studies”) conducted by, on behalf of or sponsored by the Company, or in which the Company has participated, were, and if still pending are being, conducted in accordance in all material respects with all applicable local, state and federal laws, rules and regulations of the FDA, the European Union or EEA Member States and EEA Member State Competent Authorities, and comparable Governmental Entities, including without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812 and Directive 93/42/EEC concerning medical devices and the EEA Member State laws implementing its provisions; except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus and to the knowledge of the Company, there are no Studies the results of which reasonably call into question in any material respect the results described or referred to in the Registration Statement, General Disclosure Package or the Prospectus; and no investigational new drug application or investigational device exemption application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing Studies conducted or proposed to be conducted by or on behalf of the Company.
