Preclinical Studies and Clinical Trials. The preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the FDA and any comparable foreign regulatory authority; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence with the FDA or any foreign, state or local governmental body exercising comparable authority, requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would 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 Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or debarred by the FDA. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.
Preclinical Studies and Clinical Trials. To the Company’s knowledge, the descriptions of and information regarding the preclinical studies and clinical trials, and the data and results derived therefrom, contained in the Registration Statement, the General Disclosure Package and the Prospectus are accurate and complete in all material respects and the Company and its subsidiaries, after due inquiry, are not aware of any nonclinical studies, clinical trials, or other information that would reasonably call into question the validity, completeness, or accuracy of any study, trial, results or data described in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such studies, trials, results, or data are described therein. The studies and trials conducted by or on behalf of or sponsored by the Company and its subsidiaries were and, if still pending, are being conducted in all material respect in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act (the “FDCA”) and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. Except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, no investigational new drug application submitted by or on behalf of the Company or its subsidiaries 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 clinical investigation conducted or proposed to be conducted by or on behalf of the Company or its subsidiaries.
Preclinical Studies and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”) and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, General Disclosure Package and Prospectus are accurate in all material respects; the Company is not aware of any studies, tests or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, General Disclosure Package and Prospectus; and, except as disclosed in the Registration Statement, General Disclosure Package and Prospectus, the Company has not received any written notice from the FDA or any comparable governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials. (y)
Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by on behalf of, or sponsored by, the Company, or in which the Company has participated with respect to its product candidates, that are described in the Registration Statement, the General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package or the Prospectus, as applicable, were, and if still pending, are being conducted in all material respects, and all applicable laws, rules, regulations and policies enforced by the FDA or any comparable Governmental Authority, or by any institutional review board, ethics review board or committee, in each case having authority or responsible for the oversight of such studies and trials (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies and trials are accurate in all material respects; the Company has no knowledge of any other studies or trials 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 in any material respect 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; the Company has not received any written notice, correspondence or other communications from any Regulatory Authority requiring or threatening (i) the termination, suspension or clinical hold of any preclinical studies or clinical trials being conducted by or on behalf of, or sponsored by, the Company or in which the Company is participating, or (ii) the material adverse modification of any preclinical studies or clinical trials that are described in the Registration Statement, the General Disclosure Package or the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.
Preclinical Studies and Clinical Trials. The research, preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by, on behalf of, sponsored by or being relied upon by the Company or any of its subsidiaries, including those described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package or the Prospectus, were conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies, all Permits, all Healthcare Product Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, all applicable professional and scientific standards, and all applicable requirements of the FDA, the EMA and other Regulatory Agencies, including any applicable institutional review board. Each description of such studies and the results therefrom in the Registration Statement, the General Disclosure Package or the Prospectus is accurate and complete in all material respects and fairly presents in all material respects the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies 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 or the Prospectus.
Preclinical Studies and Clinical Trials. The preclinical studies and clinical trials conducted by, on behalf of, or sponsored by the Company or its Subsidiary that are described in, or the results of which are referred to in, the SEC Filings were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the “FDA”) or any foreign governmental body exercising comparable authority (together with the FDA, the “Regulatory Authorities”), any conditions of approval and policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such preclinical studies and clinical trials, standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes and all applicable rules and regulations enforced by the FDA or other Regulatory Authorities and applicable Good Clinical Practice and Good Laboratory Practice requirements; the descriptions of the preclinical studies and clinical trials conducted by or, to the Company’s Knowledge, on behalf of the Company or its Subsidiary, contained in the SEC Filings are accurate and not misleading in all material respects; the Company has no Knowledge of any other preclinical studies and clinical trials, the results of which are inconsistent with or would call into question the results described in the SEC Filings; and neither the Company nor its Subsidiary have received any written notices or correspondence from any Regulatory Authorities or any Institutional Review Board requiring or threatening the termination, suspension, material modification or clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Company and, to the Company’s Knowledge, there are no reasonable grounds for the same.
Preclinical Studies and Clinical Trials. All studies, tests and clinical and non-clinical studies conducted by or, to the knowledge of the Company, on behalf of the Company or its affiliates have been and, if still pending, are being conducted in material compliance with research protocols and all applicable laws, including, but not limited to, the FD&C Act, its implementing regulations set forth at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and FDA guidance on the conduct of pre-clinical and clinical trials during the SARS-CoV-2 public health emergency. Except as otherwise disclosed in the Registration Statement and the Prospectus, neither the Company nor its affiliates has received any written notice that any regulatory authority, investigator, or any relevant institutional review board, independent ethics committee or any other similar body has (i) refused to approve any clinical study, or any substantial amendment to a protocol for any clinical study, conducted or proposed to be conducted by or on behalf of the Company or any of its affiliates, or (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of the Company or any of its affiliates, or suspend or terminate any investigational new drug sponsored by the Company or any of its affiliates.
Preclinical Studies and Clinical Trials. All studies, tests and clinical and non-clinical studies conducted by or, to the knowledge of the Company, on behalf of the Company or its affiliates have been and, if still pending, are being conducted in material compliance with research protocols and all applicable laws, including, but not limited to, the FD&C Act, its implementing regulations set forth at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and FDA guidance on the conduct of pre-clinical and clinical trials during the SARS-CoV-2 public health emergency. Neither the Company nor its affiliates has received any written notice that any regulatory authority, investigator, or any relevant institutional review board, independent ethics committee or any other similar body has (i) refused to approve any clinical study, or any substantial amendment to a protocol for any clinical study, conducted or proposed to be conducted by or on behalf of the Company or any of its affiliates, or (ii) initiated, or threatened to initiate, any action to suspend any clinical study conducted by or on behalf of the Company or any of its affiliates, or suspend or terminate any investigational new drug sponsored by the Company or any of its affiliates.
Preclinical Studies and Clinical Trials. (i) Except as described in the Registration Statement and the Prospectus, 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 the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with all applicable Health Care Laws; (ii) the descriptions in the Registration Statement and the Prospectus of the results of such studies and trials are, to the knowledge of the Company, accurate and complete in all material respects and fairly present the data derived therefrom; (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 inconsistent with or which the Company reasonably believes call into question the results described or referred to in the Registration Statement and the Prospectus; and (iv) the Company has not received any written notices or correspondence from the regulatory authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any pre-clinical studies or clinical 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 other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same.
Preclinical Studies and Clinical Trials. (i) The preclinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending 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, including those reflected in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Guideline for Good Clinical Practice, and all applicable statutes and all applicable Good Clinical Practice and Good Laboratory Practice rules and regulations of the U.S. Food and Drug Administration, including those at 21 C.F.R. parts 50, 56, 58, and 312, and of comparable international, country or regional regulatory agencies outside of the United States to which they are subject, including, for example, the European Medicines Agency (collectively, the “Regulatory Authorities”); (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies or trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which, in any material respect, are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities, except where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other substantive communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have ...
