Common use of Preclinical Studies and Clinical Trials Clause in Contracts

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 (i) Except as described in the Registration Statement and the Prospectus, the preclinical studies and clinical trials conducted by on behalf ofor, or sponsored by, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries or in which the Company has participated with respect to or its product candidatessubsidiaries have participated, that are described in the Registration Statement, the General Disclosure Package or Statement and the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package or Statement and the Prospectus, as applicable, were, and if still pendingpending are, are being conducted in all material respects, 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 and all applicable lawsstatutes and all applicable rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, rules, regulations and policies enforced by including 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 European Medicines Agency (collectively, the “Regulatory Authorities”)) and Good Laboratory Practices and Good Clinical Practices, as applicable, except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Change; (ii) the descriptions in the Registration Statement, the General Disclosure Package or Statement and the Prospectus of the results of such studies and trials are accurate and complete descriptions in all material respectsrespects 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 General Disclosure Package Statement 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 Statement and the Prospectus when viewed Prospectus; and (iv) except as described in the context in which such results are described Registration Statement and the current state of development; Prospectus, neither the Company has not nor any of its subsidiaries have received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any Regulatory Authority other governmental agency requiring or threatening (i) the termination, material modification or 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, Statement and the General Disclosure Package 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. The preclinical studies and tests 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 Prospectusin, or the results of which are referred to in the Registration Statement, the General Disclosure Package or Time of Sale Prospectus and the Prospectus, as applicable, Prospectus were, and and, if still pending, are being conducted in all material respectsrespects in accordance with the experimental protocols, procedures and all applicable lawscontrols pursuant to, ruleswhere applicable, regulations accepted professional and policies enforced scientific standards for products or product candidates comparable to those being developed by the FDA or any comparable Governmental AuthorityCompany, or by any institutional review board, ethics review board or committee, except in each case having authority or responsible for the oversight of such studies and trials (collectively, the “Regulatory Authorities”)where failure to comply would not be reasonably expected to have a Material Adverse Effect; the descriptions of such studies, tests and trials, and the results thereof, contained in the Registration Statement, the General Disclosure Package or Time of Sale Prospectus and the Prospectus of the results of such studies and trials are accurate and complete in all material respects; the Company has no knowledge is not aware of any other tests, studies or trials not described in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or reasonably call into question in any material respect the results of the tests, studies and trials described or referred to in the Registration Statement, the General Disclosure Package Time of Sale Prospectus and the Prospectus when viewed in the context in which such results are described Prospectus; and the current state of development; the Company has not received any written noticenotice or correspondence from the FDA or any foreign, correspondence state or other communications from local Governmental Authority exercising comparable authority or any Regulatory Authority institutional review board or comparable authority requiring or threatening (i) the termination, suspension or suspension, 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 Statementtests, 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 preclinical studies tests and clinical trials trials, and other studies conducted by or on behalf of, of the Company or sponsored by, the Company, its subsidiaries or in which the Company has participated with respect to or its product candidatessubsidiaries’ products were evaluated (collectively, “studies”) that are described in the Registration Statement, the General Disclosure Package or the Prospectusin, or the results of which are referred to in the Registration Statementin, 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 were and, if still pending, are being conducted in all material respects in accordance with the experimental protocols established for each test, 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 studies and trials, and all applicable laws, including, without limitation, the Federal Food, Drug, and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and trials are accurate complete in all material respects; , and the Company has and its subsidiaries have 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 materially inconsistent with with, or reasonably otherwise materially call into question in any material respect question, the results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus; and the Prospectus when viewed in the context in which such results are described and the current state of development; neither the Company nor any of its subsidiaries has not received any written noticenotice of, or written correspondence from, the U.S. Food and Drug Administration or other communications from any Regulatory Authority institutional review board 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 or referred to in the Registration Statement, the General Disclosure Package or the Prospectus. There has not been any violation of applicable law or regulation by the Company in its product development, other than ordinary course communications with respect submissions or reports to modifications in connection with the design and implementation of such studies any regulatory authority that could be expected to require investigation, corrective action or trials, and, to the Company’s knowledge, there are no reasonable grounds for the sameenforcement action.

Preclinical Studies and Clinical Trials. The preclinical (i) Except as described in the Registration Statement or the Prospectus, the pre-clinical studies and clinical trials conducted by or, to the knowledge of the Company, on behalf of, of or sponsored by, by the CompanyCompany or its subsidiary, or in which the Company has or its subsidiary have participated with respect to its product candidates, that are described in the Registration Statement, the General Disclosure Package Statement or the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package Statement or the Prospectus, as applicable, were, and if still pendingpending are, are being conducted in all material respects, 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 and all applicable laws, rules, statutes and all applicable rules and regulations of the Regulatory Authorities 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 current Good Clinical Practices and trials Good Laboratory Practices; (collectively, the “Regulatory Authorities”); ii) the descriptions in the Registration Statement, the General Disclosure Package Statement or the Prospectus of the results of such studies and trials are accurate and complete in all material respectsrespects 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, Statement or the General Disclosure Package and the Prospectus, Prospectus the results of which are materially 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 Statement and the Prospectus when viewed in the context in which such results are described Prospectus; and the current state of development; (iv) the Company has or its subsidiary have not received any written noticenotices, correspondence or other communications from the Regulatory Authorities or any Regulatory Authority other governmental agency requiring or threatening (i) the termination, modification or suspension or clinical hold of any preclinical studies or pre-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 Statement or the Prospectus, Prospectus or the results of which are referred to in the Registration Statement or the Prospectus other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. No investigational new drug application or comparable submission filed by or on behalf of the Company or its subsidiary with the FDA or any other Applicable Regulatory Authority has been terminated or suspended by the FDA or such other Applicable Regulatory Authority. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a company trial. In using or disclosing patient information received by the Company or its subsidiary in connection with a company trial, andthe Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, if applicable, HIPAA and the rules and regulations thereunder and any comparable foreign regulatory authority to which they are subject. To the Company’s knowledge, there are no reasonable grounds for none of the sameCompany’s trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or any other Applicable Regulatory Authority to have engaged in scientific misconduct.