Common use of Preclinical Studies and Clinical Trials Clause in Contracts

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. 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 Statement and the Prospectus are accurate and complete in all material respects and the Company and its subsidiariesSubsidiaries, 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 Statement 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 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 Lawslaws, 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 Statement and the Prospectus, no investigational new drug application submitted by or on behalf of the Company or its subsidiaries 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 subsidiariesSubsidiaries.

Preclinical Studies and Clinical Trials. To the Company’s knowledge, the descriptions of and information regarding the The preclinical studies tests and clinical trials, and other studies conducted by or on behalf of the data and Company or its subsidiaries or in which the Company or its subsidiaries’ products were evaluated (collectively, “studies”) that are described in, or the results derived therefromof which are referred to in, contained in the Registration Statement, the General Disclosure Package and or 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 respects in accordance with standard medical the experimental protocols established for each test, study or trial, as well as any conditions of approval and scientific research procedures policies imposed by any institutional review board, ethics review board or committee responsible for the oversight of such studies and trials, and all applicable Lawslaws, including, but not limited towithout limitation, the Federal Food, Drug Drug, and Cosmetic Act (the “FDCA”) and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 58, and 312. Except ; each description of the results of such studies is accurate and complete in all material respects, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise materially call into question, the results described or referred to the extent disclosed in the Registration Statement, the General Disclosure Package and or 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 Company nor any applicable foreign regulatory agency of its subsidiaries has commenced, or, to the knowledge of the Company, threatened to initiate, received any action to place a clinical hold order onwritten notice of, or otherwise terminatewritten correspondence from, delay the U.S. Food and Drug Administration or suspendinstitutional review board requiring the termination, suspension or material adverse modification of any proposed clinical trials that are described or ongoing clinical investigation conducted referred to in the Registration Statement, the General Disclosure Package or proposed to be conducted the Prospectus. There has not been any violation of applicable law or regulation by or on behalf of the Company in its product development, submissions or its subsidiariesreports to any regulatory authority that could be expected to require investigation, corrective action or enforcement action.

Preclinical Studies and Clinical Trials. To The clinical trials and pre-clinical studies conducted by or, to the knowledge of the Company’s knowledge, after due inquiry, on behalf of or sponsored by the descriptions Company or in which the Company or its products or product candidates have participated that are described in, or the results of and information regarding the preclinical studies and clinical trialswhich are referred to in, 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 respects in accordance with standard medical and scientific research procedures for products or product candidates comparable to those being developed by the Company and all applicable Lawslocal, state and federal laws, rules, regulations to which they are subject, 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 ; each description of such tests and trials, and the results thereof, contained in the General Disclosure Package is accurate and complete in all material respects and fairly presents the data about and derived from such tests and trials, 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 the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, no . No investigational new drug application submitted filed by or on behalf of the Company or its subsidiaries with the FDA U.S. Food and Drug Administration (“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 trial conducted or proposed to be conducted by or on behalf of the Company or its subsidiariesCompany.

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 (i) Except as 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 Statement and the Prospectus, no investigational new drug application submitted the pre-clinical studies and clinical trials conducted 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 or sponsored by the Company, or in which the Company has participated that are described in the Registration Statement and the Prospectus or its subsidiariesthe 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 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 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.