Clinical Studies. To the Company’s knowledge, the preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice 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.
Appears in 29 contracts
Samples: At the Market Offering Agreement (Celsion CORP), Open Market Sale Agreement (Cytosorbents Corp), Capital on Demand Sales Agreement (Celsion CORP)
Clinical Studies. To the Company’s knowledge, the preclinical studies and tests and clinical trials conducted or sponsored by the Company and described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice 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.
Appears in 4 contracts
Samples: Sales Agreement (Cytokinetics Inc), Sales Agreement (Cytokinetics Inc), Sales Agreement (Rigel Pharmaceuticals Inc)
Clinical Studies. To the Company’s knowledge, the preclinical The clinical studies and tests and clinical trials described in conducted by the Prospectus wereCompany, or to the knowledge of the Company or on behalf of the Company, have been and, if still pending, are being, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures pursuant to all Applicable Laws and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the CompanyAuthorizations; the descriptions of such studies, tests and trials, and the results thereof, of such clinical studies and tests contained in the Registration Statement and the Prospectus are accurate and complete in all material respectsrespects and fairly present the data derived from such clinical studies and tests; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is not aware of any tests, clinical studies or trials not described in the Prospectustests, the results of which the Company believes reasonably call into question the research, nonclinical or clinical study or test results of the tests, studies and trials described or referred to in the ProspectusRegistration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notice 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 entity requiring the termination, suspension, clinical hold suspension or material modification of any tests, studies clinical study or trialstest conducted by or on behalf of the Company.
Appears in 3 contracts
Samples: Open Market Sale Agreement (Ardelyx, Inc.), Open Market Sale Agreement (Ardelyx, Inc.), Open Market Sale Agreement (Ardelyx, Inc.)
Clinical Studies. To the Company’s 's knowledge, the preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being, to the Company’s 's knowledge, conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice 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.
Appears in 3 contracts
Samples: At the Market Offering Agreement, At the Market Offering Agreement (India Globalization Capital, Inc.), Sales Agreement (Celsion CORP)
Clinical Studies. To the Company’s knowledge, the preclinical The clinical studies and tests and clinical trials described in conducted by the Prospectus wereCompany or its subsidiaries or on behalf of the Company or it subsidiaries, have been and, if still pending, are being, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures pursuant to all Product Laws and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the CompanyAuthorizations; the descriptions of such studies, tests and trials, and the results thereof, of such clinical studies and tests contained in the Registration Statement and the Prospectus are accurate and complete in all material respectsrespects and fairly present the data derived from such clinical studies and tests; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is not aware of any tests, clinical studies or trials not described in the Prospectustests, the results of which the Company believes reasonably call into question the research, nonclinical or clinical study or test results of the tests, studies and trials described or referred to in the ProspectusRegistration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notice 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 entity requiring the termination, suspension, clinical hold suspension or material modification of any tests, studies clinical study or trialstest conducted by or on behalf of the Company or it subsidiaries.
Appears in 2 contracts
Samples: At the Market Sales Agreement (Aridis Pharmaceuticals, Inc.), Sales Agreement (Aridis Pharmaceuticals, Inc.)
Clinical Studies. To the Company’s knowledge, the preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is has not aware received any written communication that the results of any tests, studies or trials not described in the Prospectus, the results of which Prospectus reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice 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.
Appears in 2 contracts
Samples: Sales Agreement (ProQR Therapeutics N.V.), Sales Agreement (ProQR Therapeutics N.V.)
Clinical Studies. To the Company’s knowledge, the preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, being conducted in all material respects in accordance with the experimental protocols, procedures and controls pursuant tocompliant with, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are are, to the knowledge of the Company, accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body Governmental Authority 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.
Appears in 1 contract
Clinical Studies. To the Company’s knowledge, the preclinical studies and tests and clinical trials described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body Governmental Authority 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.
Appears in 1 contract
Samples: Sales Agreement (Biotime Inc)
Clinical Studies. To the Company’s knowledge, the The preclinical studies and tests and clinical trials conducted by or behalf of the Company and described in the Prospectus were, and, if still pending, are being, to the Company’s knowledge, being conducted in all material respects in accordance with the 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Prospectus; and the Company has not received any written notice or correspondence from the FDA United States Food and Drug Administration (“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.
Appears in 1 contract