Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company and 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 professional and scientific standards for products or product candidates comparable to those being developed by the Company and its subsidiaries; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company and its subsidiaries have not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (Aegerion Pharmaceuticals, Inc.), Underwriting Agreement (Aegerion Pharmaceuticals, Inc.)
Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company and 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 professional and scientific standards for products or product candidates comparable to those being developed by the Company and its subsidiariesCompany; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company and its subsidiaries have has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.
Appears in 2 contracts
Samples: Underwriting Agreement (Aegerion Pharmaceuticals, Inc.), Underwriting Agreement (Aegerion Pharmaceuticals, Inc.)
Preclinical Studies and Tests and Clinical Trials. The testsCompany and each of its subsidiaries has operated and currently is in compliance in all material respects with the United States Federal Food, nonclinical Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other applicable federal, state, local and foreign governmental bodies exercising comparable authority. The preclinical studies and tests and clinical trials conducted by or on behalf of the Company and or any of its subsidiaries that are described in the General Disclosure Package or the Prospectus were were, and, if still pending, are being being, conducted in all material respects in accordance with experimental protocols, procedures applicable law and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and its subsidiariesregulations; the descriptions of such studies, tests and trials, and the results thereof, conducted by or on behalf of such tests, studies and trials the Company contained in the General Disclosure Package or the Prospectus do are accurate and complete in all material respects; the Company is not contain aware of any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described or referred to in the General Disclosure Package and the Prospectus Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described or referred to in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company and its subsidiaries have has not received any notices notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority authority, or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, suspension or clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: Underwriting Agreement (Cyclacel Pharmaceuticals, Inc.)
Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company and its subsidiaries that are described in the General Disclosure Package or Time of Sale Document and the Prospectus Final Offering Memorandum 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 and scientific standards for products or product candidates comparable to those being developed by the Company and its subsidiaries; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or Time of Sale Document and the Prospectus Final Offering Memorandum do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package Time of Sale Document and the Prospectus Final Offering Memorandum the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package Time of Sale Document and the ProspectusFinal Offering Memorandum; and, except as disclosed in the General Disclosure Package Time of Sale Document and the ProspectusFinal Offering Memorandum, the Company and its subsidiaries have not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.
Appears in 1 contract
Samples: Purchase Agreement (Aegerion Pharmaceuticals, Inc.)