Common use of Clinical Trials Clause in Contracts

Clinical Trials. The preclinical and clinical studies conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the General Disclosure Package and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or study, as the case may be, and with standard medical and scientific research procedures, except in each case where failure to so conduct would not reasonably be expected to have a Material Adverse Effect; each description of the results of such studies contained in the General Disclosure Package and the Final Prospectus is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the General Disclosure Package and the Final Prospectus; the Company has not received any notices or other correspondence from the FDA or any committee thereof or from any other U.S. or foreign government or regulatory authority (collectively, the “Regulatory Authorities”) requiring the termination, suspension or material modification of any preclinical or clinical studies that are described or referred to in the General Disclosure Package and the Final Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies of the Regulatory Authorities except as would not reasonably be expected to have a Material Adverse Effect.

Appears in 4 contracts

Samples: Underwriting Agreement (AC Immune SA), Underwriting Agreement (AC Immune SA), Underwriting Agreement (AC Immune SA)

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Clinical Trials. The preclinical and clinical studies conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted on behalf of or sponsored by the Company, that are described in, or the results of which are were referred to in, the General Subscription Agreement regarding AC Immune SA as of 16 October 2015 Disclosure Package and the Final Prospectus Documents were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or studytrial, as the case may be, and with standard medical and scientific research procedures, except in each case where failure to so conduct would not reasonably be expected to have a Material Adverse Effect; each description of the results of such studies contained in the General Disclosure Package and the Final Prospectus Documents is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the General Disclosure Package and the Final ProspectusDocuments; the Company has not received any notices or other correspondence from the FDA from the U.S. Food and Drug Administration (“FDA”) or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory authority agency (collectively, the “Regulatory AuthoritiesAgencies”) requiring the termination, suspension or material modification of any preclinical or clinical studies trials that are described or referred to in the General Disclosure Package and the Final Prospectusmaterials made available to such Investor, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studiestrials; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies of the Regulatory Authorities Agencies except as would not reasonably be expected to have a Material Adverse Effect.

Appears in 3 contracts

Samples: Subscription Agreement, Subscription Agreement (AC Immune SA), Subscription Agreement (AC Immune SA)

Clinical Trials. The preclinical and clinical studies conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the General Disclosure Package and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or study, as the case may be, and with standard medical and scientific research procedures, except in each case where failure to so conduct would not reasonably be expected to have a Material Adverse Effect; each description of the results of such studies contained in the General Disclosure Package and the Final Prospectus is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the General Disclosure Package and the Final Prospectus; the Company has not received any notices or other correspondence from the FDA or any committee thereof or from any other U.S. or foreign government or regulatory authority (collectively, the “Regulatory Authorities”) requiring the termination, suspension or material modification of any preclinical or clinical studies that are described or referred to in the General Disclosure Package and the Final Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies of the Regulatory Authorities except as would not reasonably be expected to have a Material Adverse Effect.

Appears in 2 contracts

Samples: Open Market Sale (AC Immune SA), Open Market Sale (AC Immune SA)

Clinical Trials. The preclinical studies and clinical studies trials conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted or on behalf of or sponsored by the Company, that are described inin the Prospectus and Preliminary Prospectus, or the results of which are referred to in, the General Disclosure Package and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities experimental protocols established for each such test study or studytrial and all Licenses and Health Care Laws, as including, without limitation, the case may beFederal Food, Drug and with standard medical Cosmetic Act and scientific research proceduresits applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, except in each case where the failure to be so conduct in compliance has not resulted and would not reasonably be expected to have result in a Material Adverse Effect; each description the descriptions of the results of such studies and trials contained in the General Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus is are accurate and complete in all material respects and fairly presents present the data derived from such studiesstudies and trials; except to the extent disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Company has Prospectus, to the Company’s knowledge, there are no knowledge of any other studies or tests trials, the results of which are materially inconsistent with, with or otherwise materially call into question, question the study and trial results described or referred to in the General Registration Statement, the Time of Sale Disclosure Package and the Final Prospectus; no investigational new drug application filed by or on behalf of the Company has not received any notices or other correspondence from with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any committee thereof or from any other U.S. or applicable foreign government or regulatory authority (collectivelyagency has commenced, or, to the “Regulatory Authorities”) requiring the termination, suspension or material modification of any preclinical or clinical studies that are described or referred to in the General Disclosure Package and the Final Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies knowledge of the Regulatory Authorities except as would not reasonably 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 expected to have a Material Adverse Effectconducted by or on behalf of the Company.

Appears in 2 contracts

Samples: Purchase Agreement (CoLucid Pharmaceuticals, Inc.), Purchase Agreement (CoLucid Pharmaceuticals, Inc.)

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Clinical Trials. The preclinical and clinical studies conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the General Disclosure Package Time of Sale Prospectus and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or study, as the case may be, and with standard medical and scientific research procedures, except in each case where failure to so conduct would not reasonably be expected to have a Material Adverse Effect; each description of the results of such studies contained in the General Disclosure Package Time of Sale Prospectus and the Final Prospectus is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the General Disclosure Package Time of Sale Prospectus and the Final Prospectus; the Company has not received any notices or other correspondence from the FDA or any committee thereof or from any other U.S. or foreign government or regulatory authority (collectively, the “Regulatory Authorities”) requiring the termination, suspension or material modification of any preclinical or clinical studies that are described or referred to in the General Disclosure Package and Time of Sale Prospectus or the Final Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies of the Regulatory Authorities except as would not reasonably be expected to have a Material Adverse Effect.

Appears in 1 contract

Samples: Underwriting Agreement (AC Immune SA)

Clinical Trials. The preclinical and clinical studies conducted by the Company, and to the knowledge of the Company, the preclinical and clinical studies conducted on behalf of of, or sponsored by by, the Company, that are described in, or the results of which are referred to in, the General Disclosure Package Time of Sale Prospectus and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls filed with the appropriate regulatory authorities for each such test or study, as the case may be, and with standard medical and scientific research procedures, except in each case where failure to so conduct would not reasonably be expected to have a Material Adverse Effect; each description of the results of such studies contained in the General Disclosure Package Time of Sale Prospectus and the Final Prospectus is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the General Disclosure Package Time of Sale Prospectus and the Final Prospectus; the Company has not received any notices or other correspondence from the FDA or any committee thereof or from any other U.S. or foreign government or regulatory authority (collectively, the “Regulatory Authorities”) requiring the termination, suspension or material modification of any preclinical or clinical studies that are described or referred to in the General Disclosure Package and Time of Sale Prospectus or the Final Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies; and the Company has operated and currently is in compliance in all respects with all applicable rules, regulations and policies of the Regulatory Authorities except as would not reasonably be expected to have a Material Adverse Effect.

Appears in 1 contract

Samples: Underwriting Agreement (AC Immune SA)

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