Common use of Clinical Trials Clause in Contracts

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. (i) The studiesfeasibility, tests and preclinical and pre-clinical or clinical trials and other studies or tests (x) conducted by or on behalf ofof or sponsored by the Company or any of its subsidiaries, or sponsored by, the Company, or (y) in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were andas applicable, were, and if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company or any of its subsidiaries and all applicable statutesstatutes and all applicable rules, rules regulations and regulations guidance documents of the U.S. Food and Drug Administration (“FDA, the EMEA, Health Canada ”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including the European Commission and the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) the descriptions in the Prospectus of the results of such studiestrials, studies and tests are, in all material respects, accurate and trials contained in complete descriptions and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; (iii) the Company has no knowledge of any studiesother trials, studies or tests (x) conducted by or trials on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company or any of its subsidiaries has participated, not described in the Disclosure Package and the Prospectus Prospectus, the results of which reasonably call into question in any material respect are materially inconsistent with or raise questions concerning the validity of the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules, regulations, standards, guidelines and orders administered or issued by any Regulatory Authority; and (v) neither the Company nor any of its subsidiaries has not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Regulatory Authorities or any court or arbitrator or other foreigngovernmental or regulatory body, state agency or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, modification or suspension or material modification of any studiesfeasibility, tests clinical or preclinical or pre-clinical trials conducted by or on behalf ofother studies or tests that are described in the Prospectus or the results of which are referred to in the Prospectus, or sponsored byother than ordinary course communications with respect to modifications in connection with the design and implementation of such trials and tests, the Company or in which the Company has participated, and, to the Company’s knowledge, and there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, and reasonably be expected to result in a Material Adverse Effect. The studies, tests and preclinical and clinical trials 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, the Time of Sale General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated and not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale General Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific standards for products or product candidates comparable to those being developed by the Company research procedures and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectsubject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Pricing Disclosure Package or the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly present the data derived from such statements not misleadingtrials; the Company has no knowledge of any studies, tests other trials the results of which are inconsistent with or trials not call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus; the results of which reasonably call into question Company and its subsidiaries have operated and are currently in any compliance in all material respect the results respects with all applicable statutes, rules and regulations of the studiesRegulatory Authorities; neither the Company nor any of its subsidiaries have received any written notices, tests and correspondence or other communication from the Regulatory Authorities or any other governmental agency requiring or threatening the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time Pricing Disclosure Package and the Prospectus or the results of Sale which are referred to in the Registration Statement, Pricing Disclosure Package or the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, were andas applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols, standard medical and scientific research standards and procedures and controls pursuant toall applicable statutes, where applicableincluding the Federal Food, accepted professional Drug, and scientific standards for products Cosmetic Act, and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or product candidates comparable local governmental or regulatory authority performing functions similar to those being developed performed by the FDA) (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trials, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or ProspectusRegulatory Authorities; and the Company has not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studies, tests clinical or preclinical or pre-clinical trials conducted by or on behalf of, or sponsored bythat are described in the Registration Statement, the Company Pricing Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the Pricing Disclosure Package and the Prospectus, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesNone of the Company’s product candidates has received marketing approval from the FDA, tests and preclinical the Israeli Ministry of Health or any comparable drug regulatory agency outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To the Company’s knowledge, all nonclinical studies and clinical trials conducted by or on behalf of, of or sponsored by, by the Company, or in which with respect to the Company has participatedCompany’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were andas applicable (collectively, “Company Trials”), were, and if still pendingpending are, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectApplicable Laws; the descriptions in the Prospectus of the results of such studies, tests any Company Trials are accurate and trials contained complete descriptions in all material respects and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; the Company has no knowledge of any studies, tests other studies or trials not described in the Disclosure Package and the Prospectus Prospectus, the results of which reasonably are materially inconsistent with or call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or other correspondence written communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studiesCompany Trials, tests other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the trials. The Company has participated, and, obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, there are no reasonable grounds for none of the sameCompany Trials involved any investigator who has been disqualified as a clinical investigator. Except as disclosed The Company has established and administers a compliance program applicable to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees of the Company and its Subsidiaries in the Registration Statementcomplying with applicable regulatory guidelines (including, the Time of Sale Disclosure Package and the Prospectuswithout limitation, there has not been any violation of law or regulation those administered by the Company in its respective product development effortsFDA and any other foreign, submissions federal, state or reports to any local governmental or regulatory authority that could reasonably be expected performing functions similar to require investigation, corrective action or enforcement actionthose performed by the FDA to the extent applicable).

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted by the Company or, to the knowledge of the Company on behalf of the Company, in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional the medical and scientific standards for products or product candidates comparable to those being developed by research procedures described in the Company applicable trial protocols and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada United States Food and other Drug Administration and comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312. The descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Pricing Disclosure Package or the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly present the data derived from such statements not misleading; the trials. The Company has no knowledge of any studies, tests or other clinical trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. The Company and its subsidiaries have operated and are currently in compliance with all applicable statutes, rules and regulations of the studiesRegulatory Authorities, tests and except as would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received any written notices, correspondence or other written communication from the Regulatory Authorities or any other governmental agency requiring or threatening the premature termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time Pricing Disclosure Package and the Prospectus or the results of Sale which are referred to in the Registration Statement, Pricing Disclosure Package or the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Pricing Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or the Prospectus, as applicable, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada EMEA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Pricing Disclosure Package or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEA, Health Canada EMEA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, premature termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participatedparticipated that are described in the Registration Statement, the Pricing Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Prospectus, there has not been any violation of applicable law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionaction which would reasonably, in the aggregate, be expected to have a Material Adverse Effect.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiary, or in which the Company has or the Subsidiary have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiary and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including without limitation the Health Care Laws, including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus SEC Reports do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus SEC Reports the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or ProspectusSEC Reports; and neither the Company nor the Subsidiary has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledgeKnowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the ProspectusSEC Reports, there has not been any violation of law or regulation by the Company or the Subsidiary in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany and its subsidiaries, or in which the Company has and its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and its subsidiaries and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company and its subsidiaries or in which the Company has and its subsidiaries have participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company and its subsidiaries in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and All preclinical and clinical trials studies conducted by or on behalf ofof the Company that are material to the Company and the Subsidiaries, taken as a whole, are or sponsored byhave been adequately described in the Registration Statement, the Prospectus Supplement and the Prospectus in all material respects. To the Company's knowledge, after reasonable inquiry, the clinical and preclinical studies conducted by or in which on behalf of the Company has participated, and its Subsidiaries that are described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus Supplement and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus Supplement and the Prospectus, Prospectus were and, if still pendingongoing, are being conducted in material compliance with all material respects in accordance with 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 and all applicable statutes, rules laws and regulations of applicable thereto in the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to jurisdictions in which they are subject; the being conducted and with all laws and regulations applicable to preclinical and clinical studies from which data will be submitted to support marketing approval. The descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or Prospectus Supplement and the Prospectus do not contain any misstatement of a the results of such studies are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly present the data derived from such statements not misleading; studies, and the Company has no knowledge of any studies, tests large well-controlled clinical study the aggregate results of which are inconsistent with or trials not described in the Disclosure Package and the Prospectus otherwise call into question the results of which reasonably call into question in any material respect the results clinical study conducted by or on behalf of the studies, tests and trials Company that are described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; Prospectus Supplement and the Company has not received any notices Prospectus or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening results of which are referred to in the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored byRegistration Statement, the Company or in which Prospectus Supplement and the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the sameProspectus. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus Supplement and the Prospectus, there the Company has not been received any violation written notices or statements from the FDA, the European Medicines Agency ("EMEA") or any other governmental agency or authority imposing, requiring, requesting or suggesting a clinical hold, termination, suspension or material modification for or of law any clinical or regulation by preclinical studies that are described in the Company Registration Statement, the Prospectus Supplement and the Prospectus or the results of which are referred to in its respective product development effortsthe Registration Statement, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionthe Prospectus Supplement and the Prospectus and the Prospectus.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusProspectus and are intended to be submitted to any Governmental Authority or Regulatory Agency, were and, if still pending, (i) are being conducted in material compliance with applicable requirements of Good Clinical Practice and Good Laboratory Practice (“GLP”) regulations and all material respects applicable statutes, rules, and regulations, including without limitation, those contained in accordance 21 C.F.R. Parts 50, 54, 56, 58, 99 and 312 and any comparable state and foreign applicable laws or (ii) involved experimental research techniques that could not be performed by a registered GLP testing laboratory and, with protocolsappropriate notice being given to the FDA or applicable Governmental Authority or Regulatory Agency, the performance of which employed procedures and controls pursuant to, where applicable, accepted professional and scientific standards for generally used by qualified experts in animal or preclinical studies of products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectCompany; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading, and fairly present in all material respects data derived from such trials; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority Regulatory Agency or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company Company, or in which the Company has participated, 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. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials and investigations 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocolsall applicable Health Care Laws, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional regulations and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations policies of the FDAjurisdiction in which such trials, the EMEA, Health Canada studies and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they investigations are subjectbeing conducted; the descriptions of the results of such studies, tests tests, trials and trials investigations contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a are accurate and complete descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data therefrom; the Company has no knowledge of any studies, tests tests, trials or trials investigations not described in the Disclosure Package and the Prospectus Prospectus, the results of which are inconsistent with or reasonably call into question in any material respect the results of the studies, tests tests, trials and trials investigations described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAthe European Union NCAs, Health Canada or any other applicable foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or ethics committee or comparable authority or designated organization requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials or investigations conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in ; and no investigational device exemption or comparable submission filed by or on behalf of the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there Company has not been any violation of law terminated or regulation suspended by the Company in its respective product development efforts, submissions FDA or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionother applicable Governmental Authority.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Prospectus or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement, the Time of Sale Prospectus or Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiaries, or in which the Company has or the Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiaries and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States Regulatory Agencies to which they are subject, including without limitation the Health Care Laws (as defined below), including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package Registration Statement and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, Statement or the Time of Sale Disclosure Package or Prospectus; and neither the Company nor any of the Subsidiaries has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company or the Subsidiaries in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiaries, or in which the Company has or the Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiaries and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States Regulatory Agencies to which they are subject, including without limitation the Health Care Laws, including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and neither the Company nor any of the Subsidiaries has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company or the Subsidiaries in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiaries, or in which the Company has or the Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiaries and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including without limitation the Health Care Laws, including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus SEC Reports do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus SEC Reports the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or ProspectusSEC Reports; and neither the Company nor any of the Subsidiaries has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the ProspectusSEC Reports, there has not been any violation of law or regulation by the Company or the Subsidiaries in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participatedall material respects, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, such studies and clinical trials are being conducted in all material respects in accordance with (i) the clinical protocols, procedures and controls pursuant toand, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company with respect thereto and all (ii) applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject; , and the descriptions of the results of such studies, tests and clinical trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the . The Company has no knowledge of any studiesstudies or clinical trials conducted by or on behalf of Company or sponsored by Company, tests or trials which are not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and clinical trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any written notices or other written correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, and except as would not, individually or in the aggregate, have a Material Adverse Effect, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, the EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesExcept as described in the Registration Statement and the Prospectus, tests the clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of, of or sponsored by, by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, were andas applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, statutes and all applicable rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”), and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of such studies, studies and tests are accurate and trials contained complete descriptions in all material respects and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; the Company has no knowledge of any studies, tests or other trials not described in the Disclosure Package Registration Statement and the Prospectus Prospectus, the results of which reasonably are inconsistent with or call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, Statement and the Time of Sale Disclosure Package or Prospectus; and the Company has not and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company nor any of its subsidiaries have received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studies, tests clinical or preclinical or pre-clinical trials conducted by that are described in the Registration Statement and the Prospectus or on behalf ofthe results of which are referred to in the Registration Statement and the Prospectus, or sponsored by, other than ordinary course communications with respect to modifications in connection with the Company or in which the Company has participateddesign and implementation of such trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesNone of the Company’s product candidates has received marketing approval from the FDA, tests and preclinical the Israeli Ministry of Health or any comparable drug regulatory agency outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To the Company’s knowledge, all nonclinical studies and clinical trials conducted by or on behalf of, of or sponsored by, by the Company, or in which with respect to the Company has participatedCompany’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were andas applicable (collectively, “Company Trials”), were, and if still pendingpending are, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device Applicable Laws (including diagnostic product) regulatory agencies outside of the United States to which they are subjectas defined below); the descriptions in the Prospectus of the results of such studies, tests any Company Trials are accurate and trials contained complete descriptions in all material respects and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; the Company has no knowledge of any studies, tests other studies or trials not described in the Disclosure Package and the Prospectus Prospectus, the results of which reasonably are materially inconsistent with or call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company is currently in compliance in all material respects with all Applicable Laws (as defined below); the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or other correspondence written communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studiesCompany Trials, tests other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or preclinical or clinical trials conducted trials. To the extent required by or on behalf of, or sponsored byApplicable Law (as defined below), the Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in which the a Company has participated, and, to Trial. To the Company’s knowledge, there are no reasonable grounds for none of the sameCompany Trials involved any investigator who has been disqualified as a clinical investigator. Except as disclosed The Company has established and administers a compliance program currently applicable to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees of the Company and its Subsidiaries in the Registration Statementcomplying with applicable regulatory guidelines (including, the Time of Sale Disclosure Package and the Prospectuswithout limitation, there has not been any violation of law or regulation those administered by the Company in its respective product development effortsFDA and any other foreign, submissions federal, state or reports to any local governmental or regulatory authority that could reasonably be expected performing functions similar to require investigation, corrective action or enforcement actionthose performed by the FDA to the extent applicable).

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific standards for products or product candidates comparable to those being developed by the Company research procedures and all applicable statutes, rules rules, regulations and regulations policies of the U.S. Food and Drug Administration (the “FDA, the EMEA, Health Canada ”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectit is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly present the data derived from such statements not misleading; trials and the Company has no knowledge of any studies, tests other trials the results of which are inconsistent with or trials not otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus; the results of which reasonably call into question Company and its subsidiaries have operated and are currently in any compliance in all material respect the results respects with all applicable statutes, rules, regulations and policies of the studiesRegulatory Authorities; and neither the Company nor any of its subsidiaries have received any notices, tests and correspondence or other communication from the Regulatory Authorities or any other governmental agency which could reasonably lead to the early termination or suspension of any ongoing clinical trials or pre-clinical studies that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or Prospectus; and the Company has not received any notices Prospectus or other correspondence from the FDAresults of which are referred to in the Registration Statement, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening Pricing Disclosure Package and the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, Prospectus and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates devices comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEAEuropean Union and European Union Member States, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which would reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring requiring, or threatening the a clinical hold, termination, suspension or material modification of any studies, tests or preclinical studies or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the ProspectusProspectus or as would not reasonably be expected to result in a Material Adverse Effect, there has not been any violation of law or regulation by the Company in its respective product device development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or its subsidiaries, or in which the Company has or its subsidiaries have participated, that are described in the Registration Statement, Statement and the Time of Sale Disclosure Package or the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, as applicable, and are intended to be submitted to regulatory authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with 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 their protocols and all applicable statutes, rules and regulations of the United States Food and Drug Administration (the “FDA, the EMEA, Health Canada ”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectit is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or the Prospectus of the results of clinical and preclinical trials are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingtrials; the Company has no knowledge of any studies, tests or other trials not described in the Disclosure Package and the Prospectus the results of which reasonably are inconsistent with or otherwise call into question in any material respect the results described or referred to in the Registration Statement and the Prospectus; the Company and its subsidiaries have operated and are currently in compliance in all material respects with all Applicable Laws of the studiesRegulatory Authorities; neither the Company nor its subsidiaries have received any written notices, tests and correspondence or other written communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; Statement and the Company has not received any notices Prospectus or other correspondence from the FDA, EMEA, Health Canada results of which are referred to in the Registration Statement or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participatedProspectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package Registration Statement and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the ProspectusProspectus and are intended to be submitted to any Governmental Authority or Regulatory Agency, were and, if still pending, (i) are being conducted in material compliance with applicable requirements of Good Clinical Practice and Good Laboratory Practice (“GLP”) regulations and all material respects applicable statutes, rules, and regulations, including without limitation, those contained in accordance 21 C.F.R. Parts 50, 54, 56, 58, 99 and 312 and any comparable state and foreign applicable laws or (ii) involved experimental research techniques that could not be performed by a registered GLP testing laboratory and, with protocolsappropriate notice being given to the FDA or applicable Governmental Authority or Regulatory Agency, the performance of which employed procedures and controls pursuant to, where applicable, accepted professional and scientific standards for generally used by qualified experts in animal or preclinical studies of products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectCompany; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading, and fairly present in all material respects data derived from such trials; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority Regulatory Agency or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company Company, or in which the Company has participated, 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. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable Health Care Laws and other statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board institutional review board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, which violation would individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, the TGA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, the Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement, the Time of Sale Disclosure Package and or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale General Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated and not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale General Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale General Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, and reasonably be expected to result in a Material Adverse Effect.

Clinical Trials. The studies, tests Except as disclosed in the Disclosure Documents: the clinical and preclinical and clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or any of its subsidiaries, or in which the Company or any of its subsidiaries has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, were andas applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols, standard medical and scientific research standards and procedures and controls pursuant toall applicable statutes and all applicable rules and regulations of the FDA and other applicable regulatory authorities (including, where applicablewithout limitation, accepted professional and scientific standards for products any foreign, federal, state or product candidates comparable local governmental or regulatory authority performing functions similar to those being developed performed by the FDA having jurisdiction over such trials) (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement and the Prospectus of the results of such studies and tests are accurate and complete in all material respects and fairly present the data derived from such trials; neither the Company nor any of its subsidiaries has any knowledge of any other trials, the results of which are materially inconsistent with or reasonably call into question the results described or referred to in the Registration Statement or the Prospectus; the Company and each of its subsidiaries have operated at all times during the last three years and are currently in compliance with all applicable statutes, rules and regulations of the FDARegulatory Authorities except where failures to so comply would not, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained individually or in the Registration Statementaggregate, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of have a material fact or omit a material fact necessary to make such statements not misleadingMaterial Adverse Effect; neither the Company nor any of its subsidiaries has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEA, Health Canada applicable Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, material adverse modification or suspension or material modification of any studies, tests clinical or preclinical trials that are described in the Registration Statement and the Prospectus or clinical trials conducted by or on behalf of, or sponsored by, the Company or results of which are referred to in which the Company has participatedRegistration Statement and the Prospectus, and, to the Company’s knowledgebest knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, All nonclinical tests and preclinical and all clinical trials (“Studies, Trials and Tests”) 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, the Time of Sale Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or and the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with with: (1) 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 Company, and (2) all such Permits required by the United States Food and Drug Administration (the “FDA”) or any other state, local, federal or comparable foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous materials and applicable federal statutes, rules and regulations of the FDA, the EMEA, Health Canada European Medicines Agency (“EMA”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; . The descriptions in the Prospectus of the results of such Studies, Tests and Trials are accurate and complete in all material respects and fairly present the published data derived from such Studies, Tests and Trials. The descriptions of the results of such studiesStudies, tests Tests and trials Trials contained in the Registration Statement, the Time of Sale Disclosure Package or and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading; the Company has no knowledge of any studiesStudies, tests Tests or trials Trials not described in the Registration Statement, the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studiesStudies, tests Tests and trials Trials described in the Registration Statement, the Time of Sale Disclosure Package or and the Prospectus; and except as set forth in the Registration Statement, the Disclosure Package and the Prospectus, the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada EMA or any other comparable foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable ethical and scientific review authority requiring or threatening the termination, suspension or material modification of any studiesStudies, tests or preclinical or clinical trials Tests and Trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesclinical, pre-clinical and other studies and tests and preclinical and clinical trials conducted by or on behalf of, of or sponsored by, the Company, or in which by the Company has participated, or its subsidiaries that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, SEC Reports were and, if still pending, are being conducted in accordance in all material respects with all 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). The descriptions of the results of such studies and tests that are described or referred to in the SEC Reports are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no Knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the SEC Reports. Except as described in the SEC Reports, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority. The studies, tests and preclinical and clinical investigations conducted by or on behalf of the Company and its Subsidiaries were and, if still pending, are, in all material respects, being conducted in accordance with established protocols, procedures and controls pursuant to, where applicable, to accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutesHealth Care Laws and Regulatory Permits, rules and regulations of the FDAincluding, without limitation, the EMEAFDCA and its implementing regulations set forth at 21 C.F.R. Parts 50, Health Canada 54, 56, 58, and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject312; the descriptions of the results of such studies, tests and trials contained in the Registration StatementSEC Reports are accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the SEC Reports, the Time of Sale Disclosure Package or the Prospectus do Company is not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge aware of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which the Company believes reasonably call into question in any material respect respect, the study, test, or trial results of the studies, tests and trials described or referred to in the Registration Statement, SEC Reports when viewed in the Time context in which such results are described and the clinical state of Sale Disclosure Package or Prospectusdevelopment; and neither the Company has not nor any of its Subsidiaries have received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials investigations conducted by or on behalf of, or sponsored by, of the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time any of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionSubsidiaries.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, the Federal Food, Drug and Cosmetic Act; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable Health Care Laws and other statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, which violation would individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, in the Time of Sale Disclosure Package or in the Prospectus, or the results of which are referred to in the Registration Statement, in the Time of Sale Disclosure Package or in the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, in the Time of Sale Disclosure Package or in the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, in the Time of Sale Disclosure Package or in the Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada FDA or any other foreign, state or local governmental body Governmental Authority exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, in the Time of Sale Disclosure Package and in the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiaries, or in which the Company has or the Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiaries and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States Regulatory Agencies to which they are subject, including without limitation the Health Care Laws (as defined below), including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and neither the Company nor any of the Subsidiaries has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company or the Subsidiaries in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the CDHS, the EMEA, the Competent Authorities, Health Canada Canada, the MHLW, the PMDA, the CFDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, the CDHS, the EMEA, the Competent Authorities, Health Canada Canada, the MHLW, the PMDA, the CFDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any material violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials and pre-clinical studies conducted by or on behalf of, of or sponsored by, by the Company, or in which the Company has participated, that are described in the Registration Statement, Statement and the Time of Sale Disclosure Package or the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific standards for products or product candidates comparable to those being developed by the Company research procedures and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectit is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement or the Prospectus of the results of such studies, tests studies and trials contained are accurate and complete in all material respects and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; the Company has no knowledge of any studies, tests or other trials not described in the Disclosure Package and the Prospectus the results of which reasonably are inconsistent with or otherwise call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, Statement and the Time of Sale Disclosure Package or Prospectus; the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; the Company has not received any notices written notices, correspondence or other correspondence communication from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state governmental agency which could lead to the termination or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, pre-clinical studies that are described in the Registration Statement and the Prospectus or sponsored by, the Company results of which are referred to in the Registration Statement or in which the Company has participatedProspectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable Health Care Laws and other statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) 16 regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board institutional review board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action, which violation would individually or in the aggregate, reasonably be expected to result in a Material Adverse Change.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any currently conducted studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s 's knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration StatementStatements, the Time of Sale Disclosure Package or the ProspectusProspectuses, or the results of which are referred to in the Registration StatementStatements, the Time of Sale Disclosure Package or the ProspectusProspectuses, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration StatementStatements, the Time of Sale Disclosure Package or the Prospectus Prospectuses do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Time of Sale Disclosure Package and the Prospectus Prospectuses the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration StatementStatements, the Time of Sale Disclosure Package or Prospectusthe Prospectuses; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body Governmental Authority exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration StatementStatements, the Time of Sale Disclosure Package and the ProspectusProspectuses, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and or clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which of the Company has participated, that are described in the Registration Statement, Statement and the Time of Sale Disclosure Package or Prospectus (the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, “Company Studies and Trials”) were and, if still pending, are being being, conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectstandards; the descriptions of the results of such studies, tests the Company Studies and trials Trials contained in the Registration Statement, the Time of Sale Disclosure Package or Statement and the Prospectus do not contain any misstatement of a are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly presents the data derived from such statements not misleadingCompany Studies and Trials; the Company has no knowledge of any studies, tests other studies or trials not described in the Disclosure Package Registration Statement and the Prospectus Prospectus, the results of which reasonably are inconsistent with or call into in question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, Statement and the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from with the FDA, EMEA, Health Canada FDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studiesCompany Studies and Trials which termination, tests suspension or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or material modification would reasonably be expected to result in which the Company has participated, a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Registration Statement, the Time of Sale Disclosure Package Company Studies and the Prospectus, there has not been any violation of law Trials. In using or regulation disclosing patient information received by the Company in connection with 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 to have engaged in scientific misconduct. To the Company’s knowledge, the manufacturing facilities and operations of its respective product development effortssuppliers are operated in compliance in all material respects with all applicable statutes, submissions or reports rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionwhich the Company is subject.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Prospectus or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus, were and, if still pending, are are, to the Company’s knowledge, being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”), the EMEAEuropean Medicines Agency (the “EMA”), Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading, except where the failure to be in such accordance would not reasonably be expected to have a Material Adverse Effect; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Registration Statement, Time of Sale Prospectus or Prospectus the results of which the Company believes reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Prospectus or Prospectus, when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The (i) Except as would not reasonably be expected to have a Material Adverse Effect on the Company and its Subsidiaries, taken as a whole, the studies, tests and preclinical and clinical trials conducted by or or, to the Company’s knowledge, on behalf of, of or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, were, and if still pending are being conducted in accordance with standard medical and experimental protocols, procedures and controls pursuant to accepted professional scientific research standards and procedures, and all applicable Health Care Laws, the rules and regulations of the Regulatory Authorities and, to the Company’s knowledgeextent required, there are no reasonable grounds for current Good Clinical Practices and Good Laboratory Practices; (ii) the same. Except as disclosed descriptions of the results of such studies and trials contained in each of the Registration Statement, the Time Prospectus or the Prospectus Supplement are accurate and complete in all material respects and fairly present the data derived from such trials and studies; (iii) the Company has no knowledge of Sale Disclosure Package any other studies or trials not described in each of the Registration Statement, the Prospectus and the ProspectusProspectus Supplement, there the results of which are materially inconsistent with or call into question the results described or referred to in each of the Registration Statement, the Prospectus and the Prospectus Supplement; and (iv) the Company has not been received any violation written notices or correspondence from any Regulatory Authority or any other governmental entity requiring the termination, material modification or suspension of law any studies or regulation trials that are described in each of the Registration Statement, the Prospectus and the Prospectus Supplement or the results of which are referred to in each of the Registration Statement, the Prospectus and the Prospectus Supplement. The Company’s clinical laboratory tests are conducted in material compliance with all applicable Health Care Laws, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. The Company in its respective product development effortshas not received written notice from any Regulatory Authority alleging or asserting noncompliance with any applicable Health Care Law. To the Company’s Knowledge, submissions or reports to neither the FDA nor any regulatory other governmental authority that could reasonably be expected to require investigation, corrective action or enforcement is considering such action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any written notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any material violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests None of the Company’s product candidates has received marketing approval from any Applicable Regulatory Authority. All clinical and preclinical pre-clinical studies and clinical trials conducted by or on behalf of, of or sponsored by, by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Documents, or the results of which are referred to in the Registration StatementSEC Documents, the Time of Sale Disclosure Package or the Prospectusas applicable (collectively, were and“Company Trials”), were, and if still pendingpending are, are to the Company’s knowledge, being conducted in all material respects in accordance with protocolsall applicable Health Care Laws of the Applicable Regulatory Authorities, including the FDA’s current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional regulations and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations policies of the FDA, jurisdiction in which such trials and studies are being conducted. The descriptions in the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions SEC Documents of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom as of the date of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the SEC Documents. The Company has no knowledge of any studies, tests other studies or trials not described in the Disclosure Package and the Prospectus SEC Documents, the results of which reasonably are inconsistent with or call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the SEC Documents. The Company has not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Applicable Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority entity or any Institutional Review Board institutional review board (“IRB”) or comparable authority independent ethics committee (“IEC”) requiring or threatening the termination, suspension or material modification or suspension of any studiesCompany Trials, tests other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participatedtrials, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed No investigational new drug application or comparable submission filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA or any 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 the Registration Statementa Company Trial, the Time of Sale Disclosure Package and the ProspectusCompany has obtained (or caused to be obtained) applicable IRB or IEC approvals for each Company Trial. To the Company’s knowledge, there none of the Company Trials involved any investigator who has not been any violation of law disqualified as a clinical investigator or regulation has been found by the Company FDA to have engaged in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionscientific misconduct.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 601; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada EMA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Time of Sale Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada EMA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there There has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studiesExcept as disclosed in the Registration Statement and the Prospectus, tests and preclinical none of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any comparable drug regulatory agency outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To the Company’s knowledge, all nonclinical studies and clinical trials conducted by or on behalf of, of or sponsored by, by the Company, or in which with respect to the Company has participatedCompany’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were andas applicable (collectively, “Company Trials”), were, and if still pendingpending are, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectApplicable Laws; the descriptions in the Prospectus of the results of such studies, tests any Company Trials are accurate and trials contained complete descriptions in all material respects and fairly present the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleadingdata derived therefrom; the Company has no knowledge of any studies, tests other studies or trials not described in the Disclosure Package and the Prospectus Prospectus, the results of which reasonably are materially inconsistent with or call into question in any material respect the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or other correspondence written communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studiesCompany Trials, tests other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the trials. The Company has participated, and, obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, there are no reasonable grounds for none of the sameCompany Trials involved any investigator who has been disqualified as a clinical investigator. Except as disclosed The Company has established and administers a compliance program applicable to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees of the Company and its Subsidiaries in the Registration Statementcomplying with applicable regulatory guidelines (including, the Time of Sale Disclosure Package and the Prospectuswithout limitation, there has not been any violation of law or regulation those administered by the Company in its respective product development effortsFDA and any other foreign, submissions federal, state or reports to any local governmental or regulatory authority that could reasonably be expected performing functions similar to require investigation, corrective action or enforcement actionthose performed by the FDA to the extent applicable).

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials and investigations 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocolsall applicable Health Care Laws, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional regulations and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations policies of the FDAjurisdiction in which such trials, the EMEA, Health Canada studies and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they investigations are subjectbeing conducted; the descriptions of the results of such studies, tests tests, trials and trials investigations contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a are accurate and complete descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data therefrom; the Company has no knowledge of any studies, tests tests, trials or trials investigations not described in the Disclosure Package and the Prospectus Prospectus, the results of which are inconsistent with or reasonably call into question in any material respect the results of the studies, tests tests, trials and trials investigations described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAthe European Union NCAs, Health Canada or any other applicable foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority or designated organization requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials or investigations conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in ; and no investigational device exemption or comparable submission filed by or on behalf of the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there Company has not been any violation of law terminated or regulation suspended by the Company in its respective product development efforts, submissions FDA or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionother applicable Governmental Authority.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or a Subsidiary, or in which the Company or a Subsidiary has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, Prospectus and any Permitted Free Writing Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus and any Permitted Free Writing Prospectus, as applicable, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific standards for products or product candidates comparable to those being developed by the Company research procedures and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectit is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time Prospectus and any Permitted Free Writing Prospectus of Sale Disclosure Package or the Prospectus do not contain any misstatement results of a such studies and tests are accurate and complete in all material fact or omit a material fact necessary to make respects and fairly present the data derived from such statements not misleadingtrials; the Company has no knowledge of any studies, tests or other trials not described in the Disclosure Package and the Prospectus the results of which reasonably are inconsistent with or otherwise call into question in any material respect the results described or referred to in the Registration Statement, the Prospectus and any Permitted Free Writing Prospectus; the Company and each Subsidiary has operated and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the studiesRegulatory Authorities; neither the Company nor any Subsidiary has received any written notices, tests and correspondence or other communication from the Regulatory Authorities or any other governmental agency which would lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada Prospectus or any other foreignPermitted Free Writing Prospectus or the results of which are referred to in the Registration Statement, state or local governmental body exercising comparable authority the Prospectus or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participatedPermitted Free Writing Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Information or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Information or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Information or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package Time of Sale Information and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Information or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Information and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 study protocols and all applicable statutes, rules and regulations of promulgated by the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjecthaving jurisdiction over medical devices; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or and the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other written correspondence from the FDA, EMEA, Health Canada FDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, termination or suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could would reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the CompanyCompany or the Subsidiary, or in which the Company has or the Subsidiary have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusSEC Reports, were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls established for each such study, test or preclinical or clinical trial and pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company or the Subsidiary and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject, including without limitation the Health Care Laws, including 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus SEC Reports do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus SEC Reports the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or ProspectusSEC Reports; and neither the Company nor the Subsidiary has not received any notices or other correspondence from the FDA, EMEAthe EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledgeKnowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the ProspectusSEC Reports or on Schedule 3.1(nn), there has not been any violation of law or regulation by the Company or the Subsidiary in its their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials and investigations 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, the Time of Sale Disclosure Package Statement or the ProspectusProspectus or the documents incorporated by reference therein, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the ProspectusProspectus or the documents incorporated by reference therein, were and, if still pending, are being conducted in all material respects in accordance with protocolsall applicable Health Care Laws (as defined below), standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional regulations and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations policies of the FDAjurisdiction in which such trials, the EMEA, Health Canada studies and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they investigations are subjectbeing conducted; the descriptions of the results of such studies, tests tests, trials and trials investigations contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a or the documents incorporated by reference therein, are accurate and complete descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data therefrom; the Company has no knowledge of any studies, tests tests, trials or trials investigations not described in the Disclosure Package and Registration Statement or the Prospectus or the documents incorporated by reference therein, the results of which are inconsistent with or reasonably call into question in any material respect the results of the studies, tests tests, trials and trials investigations described in the Registration Statement, Statement or the Time of Sale Disclosure Package Prospectus or Prospectusthe documents incorporated by reference therein; and the Company has not received any notices or other correspondence from the FDA, EMEAthe European Union NCAs, Health Canada or any other applicable foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority or designated organization requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials or investigations conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in ; and no investigational device exemption or comparable submission filed by or on behalf of the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there Company has not been any violation of law terminated or regulation suspended by the Company in its respective product development efforts, submissions FDA or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionother applicable Governmental Authority.

Clinical Trials. The studies, tests and preclinical nonclinical and clinical trials 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, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject, including, without limitation, as applicable, 21 C.F.R. Parts 50, 54, 56, 58, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada FDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical nonclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionresult in a Material Adverse Effect.

Clinical Trials. The studies, tests clinical and preclinical and pre-clinical trials conducted by or on behalf of, of or sponsored by, by the CompanyCompany or its Subsidiaries, or in which the Company has or its Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Pricing Disclosure Package or and the Prospectus, were andas applicable, were, and if still pendingpending are, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, statutes and all applicable rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectsubject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Pricing Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make the results of such statements not misleadingstudies and tests are accurate and complete descriptions and fairly present the data derived therefrom; the Company has no knowledge of any studies, tests or other trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and the Company has not and its subsidiaries have operated at all times and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company nor any of its subsidiaries have received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Regulatory Authorities or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority agency requiring or threatening the termination, suspension or material modification or suspension of any studies, tests clinical or preclinical or pre-clinical trials conducted by or on behalf of, or sponsored bythat are described in the Registration Statement, the Company Pricing Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, and, to the Company’s best knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

Clinical Trials. The studies, tests and preclinical and clinical trials 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, the Time of Sale Disclosure Package Statement or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, were and, if still pending, are are, to the Company’s knowledge, being conducted in all material respects in accordance with 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 and all applicable statutes, rules and regulations of the FDA, the EMEAEMA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States U.S. to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading, except where the failure to be in such accordance would not reasonably be expected to have a Material Adverse Effect; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and Registration Statement or the Prospectus the results of which the Company believes reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package Statement or Prospectus, when viewed in the context in which such results are described and the clinical state of development; and the Company has not received any notices or other correspondence from the FDA, EMEAEMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.