Common use of Clinical Studies Clause in Contracts

Clinical Studies. Except to the extent disclosed in the Registration Statement and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical studies and tests conducted by or on behalf of or sponsored by the Company are, and at all times have been, conducted in all material respects in accordance with the FD&C Act and the regulations promulgated thereunder, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugs. The descriptions of the results of such trials, studies and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement and the Prospectus. Except to the extent disclosed in the Registration Statement and the Prospectus, the Company has not received any written notices or other correspondence from the FDA or any other federal, state, local or foreign governmental agency with respect to any clinical trials or pre-clinical studies or tests that are described in the Registration Statement and the Prospectus or the results of which are described in the Registration Statement and the Prospectus that require the termination, suspension, delay or modification of such trials, studies or tests, or otherwise require the Company to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected to have a Material Adverse Effect.

Clinical Studies. Except to the extent disclosed in the Registration Statement The preclinical studies, tests and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies preclinical or tests conducted by third parties), the clinical trials and pre-clinical studies and tests conducted by or on behalf of or sponsored by the Company arethat are described in the Registration Statement, the Time of Sale Prospectus and at all times have beenthe Prospectus (the “Company Studies and Trials”) were, and, if still pending, are being conducted in all material respects in accordance with the FD&C Act and the regulations promulgated thereunderexperimental protocols, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by qualified experts in the pre-clinical and clinical development of drugs. The Company; the descriptions of the Company Studies and Trials, and the results thereof, contained in the Registration Statement, the Time of such trials, studies Sale Prospectus and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit Prospectus are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and respects; the Company does is not have any knowledge aware of any other trialstests, studies or tests trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which reasonably call into question the results of the Company Studies and Trials described in the Registration Statement Statement, the Time of Sale Prospectus and the Prospectus. Except to the extent disclosed in the Registration Statement ; and the Prospectus, the Company has not received any written notices notice or other correspondence from the FDA or any other federalforeign, state, state or local Governmental Authority exercising comparable authority or foreign governmental agency with respect to any clinical trials institutional review board or pre-clinical studies or tests that are described in the Registration Statement and the Prospectus or the results of which are described in the Registration Statement and the Prospectus that require comparable authority requiring the termination, suspension, delay clinical hold or material modification of such trials, studies or tests, or otherwise require any of the Company Studies and Trials. The Company has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA (or any foreign, federal, state or local governmental or regulatory authority performing functions similar to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected those performed by the FDA) to have a Material Adverse Effectengaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject.

Clinical Studies. Except to the extent disclosed set forth in the Registration Statement and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies or tests conducted by third parties)Statement, the clinical trials and pre-clinical studies and tests conducted by or on behalf Time of or sponsored by the Company are, and at all times have been, conducted in all material respects in accordance with the FD&C Act and the regulations promulgated thereunder, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugs. The descriptions of the results of such trials, studies and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement and the Prospectus. Except to the extent disclosed in the Registration Statement Sale Disclosure Package and the Prospectus, there is no legal or governmental proceeding to which the Company has not received or any written notices of its Subsidiaries is a party or other correspondence from of which any property or assets of the Company or any of its subsidiaries is the subject, including any proceeding before the FDA or any other comparable federal, state, local or foreign governmental agency with respect bodies (it being understood that the interactions between the Company and the FDA and such comparable governmental bodies relating to any the testing, clinical trials or pre-clinical studies or tests that are development, manufacture and product approval process for its products shall not be deemed proceedings for purposes of this representation), which is required to be described in the Registration Statement and or the Prospectus or the results of which are a document incorporated by reference therein and is not described therein, or which, singularly or in the Registration Statement and the Prospectus that require the terminationaggregate, suspension, delay or modification of such trials, studies or tests, or otherwise require if determined adversely to the Company to engage in any remedial activities with respect to such trialsor its Subsidiaries, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected to have a Material Adverse Effect; and to the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities or threatened by others. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business as currently conducted, or any other federal, state or foreign agencies or bodies engaged in the regulation of medical devices, except where noncompliance would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. All preclinical and clinical studies conducted by or on behalf of the Company and submitted to regulatory authorities to support approval for commercialization of the Company’s products have been conducted by the Company, or to the Company’s knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as would not reasonably be expected to have, singly or in the aggregate, a Material Adverse Effect.

Clinical Studies. Except to the extent disclosed in the Registration Statement Statements, the General Disclosure Package and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical studies and tests conducted by or on behalf of or sponsored by the Company are, and at all times have been, conducted in all material respects in accordance with the FD&C Act and the regulations promulgated thereunder, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugs. The descriptions of the results of such trials, studies and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement Statements, the General Disclosure Package and the Prospectus. Except to the extent disclosed in the Registration Statement Statements, the General Disclosure Package and the Prospectus, the Company has not received any written notices or other correspondence from the FDA or any other federal, state, local or foreign governmental agency with respect to any clinical trials or pre-clinical studies or tests that are described in the Registration Statement Statements, the General Disclosure Package and the Prospectus or the results of which are described in the Registration Statement Statements and the Prospectus that require the termination, suspension, delay or modification of such trials, studies or tests, or otherwise require the Company to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected to have a Material Adverse Effect.

Clinical Studies. Except to the extent disclosed in the Registration Statement Statements, the General Disclosure Package and the Prospectus (and to the Company’s knowledge, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical studies and tests conducted by or on behalf of or sponsored by the Company are, and at all times have been, conducted in all material respects in accordance with the FD&C Act and the regulations promulgated thereunder, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugs. The descriptions of the results of such trials, studies and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit are accurate and complete in all material respects and fairly present the data derived from such trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement Statements, the General Disclosure Package and the Prospectus. Except to the extent disclosed in the Registration Statement Statements, the General Disclosure Package and the Prospectus, the Company has not received any written notices or other correspondence from the FDA or any other federal, state, local or foreign governmental agency with respect to any clinical trials or pre-clinical studies or tests that are described in the Registration Statement Statements, the General Disclosure Package and the Prospectus or the results of which are described in the Registration Statement and the Prospectus that require the termination, suspension, delay or modification of such trials, studies or tests, or otherwise require the Company to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions would not reasonably be expected to have a Material Adverse Effect.

Clinical Studies. Except to the extent disclosed in the Registration Statement and the Prospectus (and to the Company’s knowledgeThe clinical, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company areor in which the Company or products or product candidates have participated that are described in the Registration Statement, the Disclosure Package and at all times have beenthe Prospectus were and, if still pending, are being conducted in accordance in all material respects with all applicable federal, state or foreign statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA and current Good Laboratory and Good Clinical Practices) and in accordance with the FD&C Act and the regulations promulgated thereunderexperimental protocols, including all U.S. Food and Drug Administration (“FDA”) regulations governing clinical trials, as well as other applicable federal, state, local and foreign Laws, and consistent with the protocols submitted to the FDA and procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugspursuant to, where applicable, accepted professional scientific methods. The descriptions in the Registration Statement, the Prospectus and the Disclosure Package of the results of such trialsstudies, studies tests and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit trials are accurate and complete in all material respects and fairly present the published data derived from such studies, tests and trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement and the Prospectus. Except to the extent disclosed in the Registration Statement and the Prospectus, the The Company has not received any written notices or other correspondence from the FDA or any other foreign, federal, state, state or local governmental or foreign governmental agency regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical trials or pre-clinical studies or tests that are described in the Registration Statement and the Prospectus or the results of which are described in the Registration Statement and the Prospectus that require requiring the termination, suspension, delay suspension or material modification of such studies, tests or preclinical or clinical trials, studies which termination, suspension or tests, or otherwise require the Company to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions material modification would not reasonably be expected to have result in a Material Adverse Effect. No filing or submission to the FDA or any other federal, state or foreign regulatory body, that is intended to be the basis for any approval, contains any material statement or material false information. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing their business as prescribed by the FDA, or any other federal, state or foreign agencies or bodies, including those bodies and agencies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, result in a Material Adverse Effect. Any certificate signed by any officer of the Company and delivered to the Placement Agent or to counsel for the Placement Agent in connection with the offering of the Securities shall be deemed a representation and warranty by the Company to the Placement Agent and the Investors as to the matters covered thereby.

Clinical Studies. Except to the extent disclosed in the Registration Statement and the Prospectus (and to the Company’s knowledgeThe clinical, after due inquiry, with respect to such trials, studies or tests conducted by third parties), the clinical trials and pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company areor in which the Company or products or product candidates have participated that are described in the Registration Statement, and at all times have beenthe SEC Reports were and, if still pending, are being conducted in accordance in all material respects in accordance with all applicable federal, state or foreign statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FD&C Act and the regulations promulgated thereunder, including all U.S. Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) regulations governing clinical trialsor by any foreign, as well as other applicable federal, state, state or local and foreign Laws, and consistent with the protocols submitted governmental or regulatory authority performing functions similar to those performed by the FDA and current Good Laboratory and Good Clinical Practices) and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the pre-clinical and clinical development of drugspursuant to, where applicable, accepted professional scientific methods. The descriptions in the SEC Reports of the results of such trialsstudies, studies tests and tests that have been submitted to the FDA or other governmental authority as the basis for a Permit trials are accurate and complete in all material respects and fairly present the published data derived from such studies, tests and trials, studies and tests, and the Company does not have any knowledge of any other trials, studies or tests the results of which reasonably call into question the results described in the Registration Statement and the Prospectus. Except to the extent disclosed in the Registration Statement and the Prospectus, the The Company has not received any written notices or other correspondence from the FDA or any other foreign, federal, state, state or local governmental or foreign governmental agency regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical trials or pre-clinical studies or tests that are described in the Registration Statement and the Prospectus or the results of which are described in the Registration Statement and the Prospectus that require requiring the termination, suspension, delay suspension or material modification of such studies, tests or preclinical or clinical trials, studies which termination, suspension or tests, or otherwise require the Company to engage in any remedial activities with respect to such trials, studies or tests or threaten to impose or actually impose any fines or other disciplinary actions, except where such remedial activities or disciplinary actions material modification would not reasonably be expected to have result in a Material Adverse Effect. No filing or submission to the FDA or any other federal, state or foreign regulatory body, that is intended to be the basis for any approval, contains any material statement or material false information. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing their business as prescribed by the FDA, or any other federal, state or foreign agencies or bodies, including those bodies and agencies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, result in a Material Adverse Effect.