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 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 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 subject, including the European Medicines Agency (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 and the Prospectus do not contain any misstatement of a the results of such studies and tests 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 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 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 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 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(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical 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 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 U.S. 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, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data derived therefrom; (iii) 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 (iv) 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; and (v) 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 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. 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. (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. 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 pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, 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 the Prospectusin, or the results of which are referred to in in, the Registration Statement, the Time of Sale General Disclosure Package Package, the Prospectus or the Prospectus, any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with protocolsprotocols filed with the appropriate regulatory authorities for each such study or trial, procedures as the case may be, and controls pursuant to, where applicable, accepted professional with standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and procedures, all applicable statutes, all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”), the EMEAEuropean Medicines Agency (the “EMA”), the Israel Ministry of Health Canada (the “IMH”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; subject and Good Clinical Practices and Good Laboratory Practices, except to the descriptions extent where failure to conduct in such manner would not have a Material Adverse Effect. Each description of the results of such studies, tests studies and trials contained in the Registration Statement, the Time of Sale General Disclosure Package or Package, the Prospectus do not contain or any misstatement of a Written Testing-the-Waters Communication is 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 misleading; studies and trials, and the Company has or its subsidiaries have no knowledge of any studies, tests other studies or 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 question, the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale General Disclosure Package Package, the Prospectus or Prospectus; any Written Testing-the-Waters Communication. The Company and the Company has its subsidiaries have not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEAthe EMA, Health Canada the IMH or any committee thereof or from any other foreign, state U.S. or local governmental body exercising comparable authority foreign government or any Institutional Review Board drug 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 bymedical device regulatory agency (collectively, the Company or in which the Company has participated, and“Regulatory Agencies”) requiring or, to the Company’s knowledge, there threatening the termination, suspension or modification of any clinical trials that are no reasonable grounds for the same. Except as disclosed described or referred to in the Registration Statement, the Time General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company and its subsidiaries have operated at all times and currently are in compliance in all material respects with all applicable statutes, rules, regulations and policies 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 actionRegulatory Agencies.

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 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 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 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 clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, 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 ProspectusProspects, 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 the results of such studies and tests 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 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 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 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 clinical and preclinical and clinical nonclinical trials conducted by or or, to the knowledge of the Company, 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 andwere, 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 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 descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects 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 when viewed in the context in which such results are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and 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 Regulatory Authorities; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, 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 clinical nonclinical 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, andthe Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the Company’s knowledgedesign and implementation of such trials, 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. 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 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. 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 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 studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical 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 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 subject, including the European Medicines Agency (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 and the Prospectus do not contain any misstatement of a the results of such studies and tests 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 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 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 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 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(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and the Prospectus, the clinical and preclinical studies and clinical trials conducted by or or, to the knowledge of the Company, (x) on behalf of, of or sponsored by, by the Company, or (y) 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, 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, including the Federal Food, Drug, and Cosmetic Act, 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 Good Clinical Practices and Good Laboratory Practices; (ii) 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 trials 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 derived therefrom; (iii) the Company has no knowledge of any studies, tests other studies 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 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; (iv) 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 Regulatory Authorities; and (v) 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 studies or 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 studies and 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(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of, of or sponsored byby the Company or its subsidiaries, the Companytaken as a whole, or in which the Company has participatedor its subsidiaries, taken as a whole, have participated and 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 and all applicable rules and regulations of the SDA, NMPA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the 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; (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 and regulations of the FDA, the EMEA, Health Canada Regulatory Authorities; and other comparable drug and medical device (including diagnostic productv) 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; neither the Company has no knowledge nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in which connection with 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 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 General Disclosure Package or and the Prospectus, Final Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale General Disclosure Package or and the Final 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 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 General Disclosure Package or the Final 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 General Disclosure Package and the Prospectus Final 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 or material modification, other than modifications customarily implemented during the drug development process, of any clinical or pre-clinical trials that are described in the Registration Statement, the Time General Disclosure Package and the Final Prospectus or the results of Sale which are referred to in the Registration Statement, General Disclosure Package or the Final 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 General Disclosure Package or and the Prospectus, Prospectus or the results of which are referred to in the Registration Statement, the Time of Sale General 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 applicable 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 General 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 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 call into question in any material respect the trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company has operated and is currently in compliance in all material respects with all applicable statutes, rules and regulations of the studiesRegulatory Authorities; the Company has not 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 of Sale General Disclosure Package or Prospectus; 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 General Disclosure Package and the Company has participatedProspectus, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed The Company is not aware of any studies, tests or trials the results of which reasonably call into question in any material respect the clinical trial results described or referred to in the Registration Statement, the Time of Sale General Disclosure Package and or the Prospectus, there . The Company has not been received any violation written notices or other correspondence from the FDA, an Institutional Review Board or other governmental agency requiring or recommending the termination, suspension or material modification of law any clinical trials conducted or regulation by intended to be conducted by, or on behalf of, the Company or 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 actionwhich the Company has participated.

Clinical Trials. The studiesExcept as would not, tests individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the clinical and preclinical and clinical nonclinical 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 or its subsidiaries 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 andwere, 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 or its subsidiaries, 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, without limitation, the China Food and Drug Administration, the Pharmaceuticals and Medical Devices Agency of Japan, and the European Medicines Agency (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 and the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete descriptions in all material fact or omit a respects and fairly present in all material fact necessary to make such statements not misleadingrespects 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 when viewed in the context in which such results are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; the Company and its subsidiaries have operated at all times and are currently in compliance, in each case in all material respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, 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 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 clinical nonclinical 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 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 trials and preclinical and clinical trials studies conducted by or or, to the knowledge of the Company after due inquiry, 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 General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 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 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 trials and trials studies contained in the Registration Statement, the Time of Sale General Disclosure Package or 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 present the data derived from such statements not misleadingtrials and studies; 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 General 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 General Disclosure Package and the 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 Laws 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 trials or preclinical or clinical trials conducted by or on behalf of, or sponsored bystudies that are described in the Registration Statement, the Company General Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the General 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 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(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or on behalf ofor, or sponsored by, to the knowledge of the Company, (x) on behalf of or sponsored by the Company or any of its subsidiaries, or (y) in which the Company has or any of 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 or any of its subsidiaries and all applicable statutes, statutes and all applicable rules and regulations of the FDA, the EMEA, Health Canada U.S. 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, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data derived therefrom; (iii) 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 (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 and regulations of the Regulatory Authorities; 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 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 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 clinical trials conducted by or by, on behalf of, of or sponsored by, by the CompanyCompany or its Subsidiary, or in which the Company or its Subsidiary has participated, that are described in the Registration Statement, the Time of Sale General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 standards for products or product candidates comparable to those being developed by the Company research procedures, standard industry practice, current Good Clinical Practices and Good Laboratory Practices 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”); 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 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 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 General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company has not and its Subsidiary 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 its Subsidiary 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 clinical trials conducted by or on behalf of, or sponsored bythat are described in the Registration Statement, the Company General Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the General 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 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, tests and preclinical and clinical nonclinical 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 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 and all 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) (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; neither the Company nor any of its subsidiaries has any 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 and each of 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 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 subjectRegulatory Authorities; 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; neither the Company nor any of its subsidiaries has no knowledge received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any studiesclinical, tests preclinical or nonclinical 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 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 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 Pricing Disclosure Package and the Company has participatedProspectus, 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, tests clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, 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 General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 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”) 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 General 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 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 General 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 General Disclosure Package and the 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 or on behalf of, or sponsored bythat are described in the Registration Statement, the Company General Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the General 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 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 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 clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, 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 General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 General Disclosure Package or the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects of data derived therefrom; the Company has no knowledge of any studies, tests or other trials not described in the Registration Statement, the General Disclosure Package and the Prospectus Prospectus, the results of which reasonably call into question in any material respect the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company and its subsidiaries have 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 of its subsidiaries have received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials that are described in the Registration Statement, the Time of Sale General Disclosure Package or Prospectus; 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 General Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in which connection with the Company has participateddesign and implementation of such trials, and, to the knowledge of the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statementsuch termination, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law material modification 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 actionsuspension.

Clinical Trials. The studies(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, (x) on behalf of, of or sponsored by, by the Company, or (y) 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, 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 U.S. 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, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material fact or omit a material fact necessary to make such statements not misleadingrespects and fairly present the data derived therefrom; (iii) 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; (iv) the Company has operated at all times and are currently in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities; and (v) 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, other than ordinary course communications with respect to modifications in connection with the design 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 studies, tests and preclinical pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, 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 the Prospectusin, or the results of which are referred to in in, the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus, Prospectus were and, if still pending, are being conducted in all material respects in accordance with protocolsprotocols filed with the appropriate regulatory authorities for each such study or trial, procedures as the case may be, and controls pursuant to, where applicable, accepted professional with standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and procedures, all applicable statutes, all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”), the EMEAEuropean Medicines Agency (the “EMA”), the Israel Ministry of Health Canada (the “IMH”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; subject and Good Clinical Practices and Good Laboratory Practices, except to the descriptions extent where failure to conduct in such manner would not result in a Material Adverse Change. Each description of the results of such studies, tests studies and trials contained in the Registration Statement, the Time of Sale Disclosure Package Statement or the Prospectus do not contain any misstatement of a is 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 misleading; studies and trials, and the Company has or its subsidiaries have no knowledge of any studies, tests other studies or 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 question, the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; Statement and the Prospectus. The Company has and its subsidiaries have not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEAthe EMA, Health Canada the IMH or any committee thereof or from any other foreign, state U.S. or local governmental body exercising comparable authority foreign government or any Institutional Review Board drug 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 bymedical device regulatory agency (collectively, the Company or in which the Company has participated, and“Regulatory Agencies”) requiring or, to the Company’s knowledge, there threatening the termination, suspension or modification of any clinical trials that are no reasonable grounds for the same. Except as disclosed described or referred to in the Registration Statement, the Time of Sale Disclosure Package and Statement or the Prospectus. The Company and its subsidiaries have operated at all times and currently are in compliance in all material respects with all applicable statutes, there has not been any violation rules, regulations and policies 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 actionRegulatory Agencies.

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 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 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 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 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 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 which could lead to 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 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 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 studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf ofof or sponsored by the Company or its subsidiaries, or sponsored by, the Company, or (y) in which the Company or its subsidiaries 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, 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 its subsidiaries and all applicable statutes and all rules and regulations of the FDA and other comparable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (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 descriptions 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 the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; the Company and its subsidiaries have 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 subjectRegulatory Authorities; 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; neither the Company has no knowledge nor its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and 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 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 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 studies, tests clinical and preclinical and pre-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 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 for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDAFDA and other applicable regulatory authorities (collectively, the EMEA, Health Canada “Regulatory Authorities”) and other comparable drug current Good Clinical Practices and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectGood Laboratory Practices; 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 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; neither the Company nor any of its subsidiaries has any knowledge of any other trials, the results of which reasonably are inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; the Company and each of 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 studiesRegulatory Authorities; neither the Company nor any of its subsidiaries has received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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 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 Pricing Disclosure Package and the Company has participatedProspectus, 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, 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 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 studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf ofof or sponsored by the Company or its subsidiary, or sponsored by, the Company, or (y) in which the Company or its subsidiary 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, 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 its subsidiary and in material compliance with all applicable statutes and all rules and regulations of the FDA and other comparable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (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 descriptions in all material respects and fairly present the data derived from such trials; the Company does not have any knowledge of any other studies or trials, the results of which the Company believes are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; the Company and its subsidiary have operated at all times and are 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 subjectRegulatory Authorities; 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; neither the Company has no knowledge nor its subsidiary have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and 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 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 clinical and preclinical and pre-clinical trials conducted by or or, to the Knowledge of Borrower, on behalf of, of or sponsored by, the Companyby Borrower or its Subsidiaries, or in which the Company has Borrower or its Subsidiaries have participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the ProspectusExchange Act Documents, or the results of which are referred to in the Registration StatementExchange Act Documents, the Time of Sale Disclosure Package or the Prospectusas applicable, were andwere, 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 Borrower and all applicable statutes, rules and regulations Requirements of Laws 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; subject (each, a “Regulatory Agency”) and current Good Clinical Practices and Good Laboratory Practices. The descriptions in the descriptions Exchange Act Documents of the results of such studiesstudies and tests, tests when they were filed with the SEC, were accurate and trials contained complete descriptions in all material respects and fairly presented 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 data derived therefrom. Borrower has no knowledge Knowledge of any studies, tests or other trials not described in the Disclosure Package and the Prospectus Exchange Act Documents, the results of which reasonably are inconsistent with or call into question in any material respect the results described or referred to in the Exchange Act Documents. Borrower and its Subsidiaries have operated at all times and are currently in compliance in all material respects with all Requirements of Laws of the studies, tests and trials described in the Registration Statement, the Time Regulatory Agencies. Neither Borrower nor any of Sale Disclosure Package or Prospectus; and the Company has not its Subsidiaries have received any notices written notices, correspondence or other correspondence communications from the FDA, EMEA, Health Canada Regulatory Agencies or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority Governmental Authority 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 Exchange Act Documents or on behalf ofthe results of which are referred to in the Exchange Act Documents, 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 CompanyBorrower’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 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 pre-clinical trials studies conducted by or or, to the knowledge of the Company after due inquiry, 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, procedures and controls pursuant to, where applicable, accepted professional and standard scientific research standards 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 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 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 such studies are accurate and complete descriptions in all material respects and fairly present the data derived therefrom. The Company has not conducted or sponsored any human clinical studies, except for certain human clinical studies that were conducted or sponsored in conjunction with a collaboration with Shionogi Co., Ltd. (“Shionogi”), which reasonably call into question studies ended on April 8, 2010. The clinical studies with Shionogi were conducted in any all material respect the results respects in accordance with standard medical and scientific research standards and all applicable statutes and all applicable rules and regulations of the studiesRegulatory Authorities and current Good Clinical Practices. To the Company’s knowledge, tests and trials based solely on information provided by its collaboration partners after due inquiry, the clinical studies 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, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and all applicable statutes and all applicable rules and regulations of the Regulatory Authorities and current Good Clinical Practices and the descriptions in the Registration Statement, the Pricing Disclosure Package or the Prospectus of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived therefrom. The Company has no knowledge of any other studies or trials not described in the Registration Statement, the 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; 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 Regulatory Authorities; the Company has not received received, nor does it have knowledge after due inquiry that any notices of its collaboration partners has received, any 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 pre-clinical studies or 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 studies or 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 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(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of, of or sponsored byby the Company or its subsidiaries, the Companytaken as a whole, or in which the Company has participatedor its subsidiaries, taken as a whole, have participated and 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 and all applicable rules and regulations of the SDA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the 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; (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 and regulations of the FDA, the EMEA, Health Canada Regulatory Authorities; and other comparable drug and medical device (including diagnostic productv) 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; neither the Company has no knowledge nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in which connection with 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 studies, tests None of the Company’s Product Candidates have received marketing approval from any Regulatory Authority. All clinical trials and preclinical and clinical trials studies 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, the Time of Sale Disclosure Package or Prospectus and the Prospectus, or (collectively, “Company Trials”), were and, if still pending are being, conducted in all material respects in accordance with all Applicable Laws, and accepted professional scientific standards, except where the results of which are referred failure to so conduct would not be reasonably expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the Time of Sale Disclosure Package or Prospectus and 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 Prospectus of the results of such studies, tests any Company Trials are accurate and trials contained non-misleading descriptions in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a all material fact or omit a material fact necessary to make such statements not misleadingrespects; the Company has no knowledge of any studies, tests other studies 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; 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 byProspectus, the Company or results of which reasonably contradict in which any material respect the results of the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed Trials described in the Registration Statement, the Time of Sale Disclosure Package Prospectus and the Prospectus, there ; the Company has not been received any violation written notices, correspondence, or other communication from the FDA or any other Governmental Agency requiring the termination, material modification or suspension of law Company Trials, which termination, material modification or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could suspension would reasonably be expected to require investigationhave a Material Adverse Effect. To the Company’s knowledge, corrective action none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or enforcement actionhas been found by the FDA to have engaged in scientific misconduct.

Clinical Trials. The studies(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of, of or sponsored byby the Company or its subsidiaries, the Companytaken as a whole, or in which the Company has participatedor its subsidiaries, taken as a whole, 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 and all applicable rules and regulations of the CFDA and comparable regulatory agencies outside of China to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (ii) 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 descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other trials not described in the Registration Statement, the 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; (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 and regulations of the FDA, the EMEA, Health Canada Regulatory Authorities; and other comparable drug and medical device (including diagnostic productv) 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; neither the Company has no knowledge nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in which connection with 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 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 studiesExcept in each case as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus: (1) the clinical and pre-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 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 accordance in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDAFDA and other applicable regulatory authorities (collectively, the EMEA, Health Canada “Regulatory Authorities”) and other comparable drug current Good Clinical Practices and medical device Good Laboratory Practices; (including diagnostic product2) 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 Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete and fairly present in all material respects the data derived from such trials; (3) neither the Company nor any of its subsidiaries has any knowledge of any other trials, the results of which reasonably are inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; (4) the Company and each of 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 studiesRegulatory Authorities; and (5) neither the Company nor any of its subsidiaries has received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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 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 Pricing Disclosure Package and the Company has participatedProspectus, 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, tests clinical and preclinical and clinical trials conducted by or by, 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 General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 standards for products or product candidates comparable to those being developed by the Company research procedures, standard industry practice, current Good Clinical Practices and Good Laboratory Practices 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”); 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 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 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 General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the 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 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 clinical trials conducted by or on behalf of, or sponsored bythat are described in the Registration Statement, the Company General Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the General 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 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. (a) The studies, tests clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, 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, 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 all applicable statutes 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”) 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 fairly present in all material fact or omit a material fact necessary to make such statements not misleadingrespects 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; the Company has operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities except for non-compliance which would not reasonably be expected to have a Material Adverse Effect; the Company has not received any notices written notices, correspondence or other correspondence communications 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 Regulatory Authorities 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 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 or, to the Company’s knowledge, 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, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and procedures and all applicable statutes, statutes and all rules and regulations of the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) (collectively, the EMEA, Health Canada “Regulatory Authorities”) and other comparable drug current Good Clinical Practices and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectGood 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 misleadingtrials; the Company has no knowledge of any studiesother trials, tests the results of which the Company believes are inconsistent with or trials not reasonably call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus Prospectus, the results Company has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of which reasonably call into question in any material respect the results clinical or pre-clinical trials conducted by or on behalf of the studies, tests and trials Company 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 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 Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in which connection with the Company has participateddesign and implementation of such trials, and, 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 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 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 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 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 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 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. (i) The studies, tests clinical and preclinical and 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, 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 Practice requirements; (ii) 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 trials 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 derived therefrom; (iii) 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; (iv) 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 Regulatory Authorities; and (v) 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 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 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 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 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, 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; 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, the Pricing Disclosure Package or the Prospectus; the Company and each of its subsidiaries have operated at all times since January 1, 2019 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 received any written notices or correspondence from the applicable Regulatory Authorities or any other governmental agency requiring or threatening the termination, material adverse modification or suspension of any studies, tests clinical or preclinical 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 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 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 Pricing Disclosure Package and the Company has participatedProspectus, 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, tests clinical trials and preclinical and clinical trials studies conducted by or or, to the knowledge of the Company after due inquiry, 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 General Disclosure Package or and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale General 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 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 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 studiesthe clinical trials and preclinical studies conducted on the Company’s product candidates or conducted by or, tests and trials to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries contained in the Registration Statement, the Time of Sale General Disclosure Package or 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 present the data derived from such statements not misleadingtrials and studies; 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 General 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 General Disclosure Package and the 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 Laws 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 trials or preclinical or clinical trials conducted by or on behalf of, or sponsored bystudies that are described in the Registration Statement, the Company General Disclosure Package and the Prospectus or the results of which are referred to in which the Company has participatedRegistration Statement, the General 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 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 ofor, or sponsored by, to the knowledge of the Company, after due inquiry, on behalf of or in which sponsored by the Company has participatedor its subsidiaries, (the “Clinical Studies”) that are described in, or the results of which are referred to in the Registration StatementStatement and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance and in compliance with the protocols, procedures and controls designed and approved for such Clinical Studies, with standard medical and scientific research procedures, including applicable statutes, rules and regulations of the European Medicines Agency, the Time U.S. Food and Drug Administration and other comparable regulatory agencies outside of Sale Disclosure Package the United States and the European Union to which they are subject (collectively, the “Regulatory Authorities”) and with current Good Clinical Practices and Good Laboratory Practices, except where the failure to be in compliance has not resulted and would not reasonably be expected to result in a Material Adverse Effect. The descriptions of the Clinical Studies in the Registration Statement and the Prospectus, or the results of the Clinical Studies which are referred to in the Registration Statement and the Prospectus, are accurate and complete descriptions in all material respects and present fairly the data derived therefrom. The Company has no knowledge of any other Clinical Study not disclosed in the Registration 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 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 are materially 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, the Time of Sale Disclosure Package or Prospectus; Statement and the Company has not Prospectus. Except as disclosed in the Registration Statement and the Prospectus, neither it nor any of its subsidiaries have received any notices written notices, correspondence or other correspondence written communications 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 Regulatory Authorities 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 ofthat are disclosed in the Registration Statement and the Prospectus, or sponsored bythe results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the 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 studies, preclinical 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 Prospectusin, or the results of which are referred to in in, the Registration Statement, a Preliminary Prospectus, the Time of Sale Disclosure Package Pricing Prospectus, the Prospectus or the a Permitted Free Writing Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocolsprotocols filed with the appropriate regulatory authorities for each such test or trial, procedures as the case may be, and controls pursuant to, where applicable, accepted professional with standard clinical 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 subjectresearch procedures; the descriptions description of the results of such studies, tests and trials contained in the Registration Statement, a Preliminary Prospectus, the Time of Sale Disclosure Package or Pricing Prospectus, the Prospectus do not contain any misstatement of or a Permitted Free Writing Prospectus, 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; tests and trials, and the Company has and each of its subsidiaries have no knowledge of any studies, other studies or tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect dispute, contradict or show to be untrue the results of the studies, tests and trials described or referred to in the Registration Statement, a Preliminary Prospectus, the Time of Sale Disclosure Package Pricing Prospectus, the Prospectus or a Permitted Free Writing Prospectus; and except as previously disclosed to the Underwriters, neither the Company nor any subsidiary has not received any notices or other correspondence from the United States Food and Drug Administration (the “FDA, EMEA, Health Canada ”) or from any other foreign, state U.S. or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority foreign government agency requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by that are described or on behalf of, or sponsored by, the Company or in which the Company has participated, and, referred to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, a Preliminary Prospectus, the Time of Sale Disclosure Package Pricing Prospectus, the Prospectus or a Permitted Free Writing Prospectus; and the ProspectusCompany and each subsidiary have each operated and currently are in compliance in all material respects with all applicable rules, there has not been any violation regulations and policies 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 actionFDA.

Clinical Trials. The studiesclinical, tests and preclinical and clinical nonclinical trials and 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, 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 Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending are, being conducted in accordance with standard medical and scientific research standards and procedures and in material compliance with all applicable statutes and all rules and regulations of Sale the FDA and other applicable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those 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 and fairly present the data derived from such trials or studies; 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, were and, if still pending, are being conducted ; the Company has operated at all times and is currently in compliance 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 misleadingRegulatory Authorities; the Company has no knowledge not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any studiesclinical, tests preclinical or nonclinical 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 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 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 Pricing Disclosure Package and the Company has participatedProspectus, and, to the best 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 studies, tests clinical and preclinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, 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 StatementStatement and the Prospects, the Time of Sale Disclosure Package or the Prospectusas applicable, were andwere, 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 in the Registration Statement or 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 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 studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf of, of or sponsored by, by the Company, or (y) 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, 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 rules and regulations of the FDA, the EMEA, Health Canada FDA and other comparable drug and medical device regulatory authorities (including diagnostic productincluding, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) 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 and the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete descriptions 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 studiesother trials, tests or trials not described in the Disclosure Package and the Prospectus the results of which the Company believes are inconsistent with or reasonably call into question in any material respect 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 studiesRegulatory Authorities; the Company has not received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials 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 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 Pricing Disclosure Package and 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 studiesNone of the Company’s product candidates have received marketing approval or licensure from any Applicable Regulatory Authority. Except as described in the SEC Documents, tests all clinical and preclinical pre-clinical studies and clinical trials sponsored or conducted by or on behalf of, of the Company or sponsored by, the Companyits Subsidiaries, or in which the Company or its Subsidiaries has participatedparticipated with respect to the Company’s product candidates, including without limitation, 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 protocolsthe Health Care Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices, and in keeping with 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, the EMEA, Health Canada jurisdiction in which such trials and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they studies are subjectbeing conducted; the descriptions in the SEC Documents of the structure and 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 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 ProspectusSEC Documents; and the Company has and each of its Subsidiaries have not received 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 or any Institutional Review Board or comparable authority entity requiring or threatening the termination, suspension or material modification or suspension of any studiesCompany Trials that are described in the SEC Documents or the results of which are referred to in the SEC Documents, 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 or any of its Subsidiaries 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 Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law a Company Trial. In using or regulation disclosing patient information received by the Company or any of its Subsidiaries in its respective product development effortsconnection with a Company Trial, submissions the Company or reports such subsidiary has complied in all material respects with all applicable laws and regulatory rules or requirements, including, without limitation, HIPAA and the rules and regulations thereunder and any similar foreign laws and regulations in Europe or elsewhere. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or any other Applicable Regulatory Authority to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement actionhave engaged in scientific misconduct.

Clinical Trials. The studies(i) Except as described in the Registration Statement, tests the Pricing Disclosure Package and the Prospectus, the clinical and preclinical studies and clinical trials conducted by or or, to the knowledge of the Company, (x) on behalf of, of or sponsored by, by the Company, or (y) 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, 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 U.S. 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, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and Good Clinical Practices and Good Laboratory Practices; (ii) 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 trials 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 derived therefrom; (iii) the Company has no knowledge of any studies, tests other studies 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 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; (iv) 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 Regulatory Authorities; and (v) 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 studies or 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 studies and 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 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 pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, 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 the Prospectusin, or the results of which are referred to in in, the Registration Statement, the Time of Sale Disclosure Package Prospectus or the Prospectus, any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with protocolsprotocols filed with the appropriate regulatory authorities for each such study or trial, procedures as the case may be, and controls pursuant to, where applicable, accepted professional with standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and procedures, all applicable statutes, all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”), the EMEAEuropean Medicines Agency (the “EMA”), the Israel Ministry of Health Canada (the “IMH”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; subject and Good Clinical Practices and Good Laboratory Practices, except to the descriptions extent where failure to conduct in such manner would not have a Material Adverse Effect. Each description of the results of such studies, tests studies and trials contained in the Registration Statement, the Time of Sale Disclosure Package Prospectus or any Written Testing-the-Waters Communication is accurate and complete in all material respects and fairly presents the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make data derived from such statements not misleading; studies and trials, and the Company has or its subsidiaries have no knowledge of any studies, tests other studies or 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 question, the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale Disclosure Package Prospectus or Prospectus; any Written Testing-the-Waters Communication. The Company and the Company has its subsidiaries have not received any notices written notices, correspondence or other correspondence communications from the FDA, EMEAthe EMA, Health Canada the IMH or any committee thereof or from any other foreign, state U.S. or local governmental body exercising comparable authority foreign government or any Institutional Review Board drug 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 bymedical device regulatory agency (collectively, the Company or in which the Company has participated, and“Regulatory Agencies”) requiring or, to the Company’s knowledge, there threatening the termination, suspension or modification of any clinical trials that are no reasonable grounds for the same. Except as disclosed described or referred to in the Registration Statement, the Time Prospectus or any Written Testing-the-Waters Communication. The Company and its subsidiaries have operated at all times and currently are in compliance in all material respects with all applicable statutes, rules, regulations and policies 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 actionRegulatory Agencies.

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 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 studiesExcept as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus, the clinical and pre-clinical trials conducted by or or, to the Company’s knowledge, (x) on behalf of, of or sponsored by, by the Company, or (y) 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, 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 in material compliance with all applicable statutes and all rules and regulations of the FDA and other comparable regulatory authorities (including, without limitation, any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) to which they are subject (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 descriptions in all material respects and fairly present the data derived from such trials; the Company does not have any knowledge of any other studies or trials, the results of which the Company believes are inconsistent with or reasonably 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 misleadingRegulatory Authorities; the Company has no knowledge not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any studies, tests clinical or pre-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 of the studies, tests and trials 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 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 Pricing Disclosure Package and 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 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 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 the results of such studies and tests 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 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 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 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, 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 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 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 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.

Clinical Trials. The studiesExcept as would not, tests individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the clinical and preclinical and clinical nonclinical 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 or its subsidiaries 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 andwere, 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 or its subsidiaries, 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, without limitation, the National Medical Products Administration (formerly known as the China Food and Drug Administration), the Pharmaceuticals and Medical Devices Agency of Japan, and the European Medicines Agency (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 and the Prospectus do not contain any misstatement of a the results of such studies and tests are accurate and complete descriptions in all material fact or omit a respects and fairly present in all material fact necessary to make such statements not misleadingrespects 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 when viewed in the context in which such results are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus; the Company and its subsidiaries have operated at all times and are currently in compliance, in each case in all material respects, with all applicable statutes, rules and regulations of the Regulatory Authorities; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, 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 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 clinical nonclinical 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 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 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 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 for products or product candidates comparable to those being developed by the Company and procedures and all applicable statutes, rules and regulations of the FDAFDA and other applicable regulatory authorities (collectively, the EMEA, Health Canada “Regulatory Authorities”) and other comparable drug current Good Clinical Practices and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subjectGood Laboratory Practices; 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 Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete 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 reasonably are inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; the Company and each of 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 studiesRegulatory Authorities; neither the Company nor any of its subsidiaries has received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, modification or suspension of any clinical or pre-clinical trials 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 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 Pricing Disclosure Package and the Company has participatedProspectus, and, to the Company’s knowledgeknowledge 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, 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 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 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 studiesExcept for sotrovimab, tests none of Vir’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, the Companyby Vir, or in which the Company Vir has participated, with respect to Vir’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 Vir’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 Company SEC Documents. Vir 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 Company SEC Documents. Vir 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 CompanyVir’s knowledge, there are no reasonable grounds for the same. Except as disclosed in No investigational new drug application or comparable submission filed by or on behalf of Vir with the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there FDA has not been any violation of law terminated or regulation suspended by the FDA or any other Applicable Regulatory Authority. Vir has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in a Company Trial, and Vir has obtained (or caused to be obtained) applicable IRB or IEC approvals for each Company Trial. To Vir’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the 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 studiesExcept in each case as described in the Registration Statement, tests the Pricing Disclosure Package and preclinical the Prospectus: (1) the clinical and pre-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 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 accordance in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDAFDA and other applicable regulatory authorities (collectively, the EMEA, Health Canada “Regulatory Authorities”) and other comparable drug current Good Clinical Practices and medical device Good Laboratory Practices; (including diagnostic product2) 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 Pricing Disclosure Package and the Prospectus of the results of such studies and tests are accurate and complete and fairly present in all material respects the data derived from such trials; (3) neither the Company nor any of its subsidiaries has any knowledge of any other trials, the results of which reasonably are inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; (4) the Company and each of its subsidiaries are currently in compliance in all material respects with all applicable statutes, rules and regulations of the studiesRegulatory Authorities; and (5) neither the Company nor any of its subsidiaries has received any written notices, tests and correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of any clinical or pre-clinical trials 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 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 Pricing Disclosure Package and the Company has participatedProspectus, 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, 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 and preclinical pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, 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 the Prospectusin, or the results of which are referred to in in, the Registration Statement, the Time of Sale General Disclosure Package Package, the Prospectus or the Prospectus, any Written Testing-the-Waters Communication were and, if still pending, are being conducted in all material respects in accordance with protocolsprotocols filed with the appropriate regulatory authorities for each such study or trial, procedures as the case may be, and controls pursuant to, where applicable, accepted professional with standard medical and scientific research standards for products or product candidates comparable to those being developed by the Company and procedures, all applicable statutes, all applicable rules and regulations of the United States Food and Drug Administration (the “FDA”), the EMEAEuropean Medicines Agency (the “EMA”), the Israel Ministry of Health Canada (the “IMH”) and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; subject and Good Clinical Practices and Good Laboratory Practices, except to the descriptions extent where failure to conduct in such manner would not have a Material Adverse Effect. Each description of the results of such studies, tests studies and trials contained in the Registration Statement, the Time of Sale General Disclosure Package or Package, the Prospectus do not contain or any misstatement of a Written Testing-the-Waters Communication is 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 misleading; studies and trials, and the Company has or its subsidiaries have no knowledge of any studies, tests other studies or 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 question, the results of the studies, tests and trials described or referred to in the Registration Statement, the Time of Sale General Disclosure Package or Prospectus; and Package, the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada Prospectus 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 sameWritten Testing-the-Waters Communication. 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 and its subsidiaries have not received any written notices, correspondence or other communications from the FDA, the EMA, the IMH or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the “Regulatory Agencies”) requiring or, to the Company’s knowledge, threatening the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package, the Prospectus or any Written Testing-the-Waters Communication. The Company and its respective product development effortssubsidiaries have operated at all times and currently are in compliance in all material respects with all applicable statutes, submissions or reports to any regulatory authority that could reasonably be expected to require investigationrules, corrective action or enforcement actionregulations and policies of the Regulatory Agencies.