Common use of Clinical Trials Clause in Contracts

Clinical Trials. 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 or sponsored by the Company, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable).

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research procedures and all Applicable Lawsapplicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, with respect to or in which the Company’s product candidatesCompany has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable statutes, including the Federal Food, Drug, and Cosmetic Act, and all applicable 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 “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company has operated at all times and is currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; and the Company has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeand, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable to the Company and its Subsidiaries, to assist knowledge of the Company, its Subsidiaries and their directors, officers and employees of there are no reasonable grounds for the Company and its Subsidiaries in complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement, and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)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 Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeand, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”)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 Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially 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 is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement, other than ordinary course communications with respect the Pricing Disclosure Package and the Prospectus or the results of which are referred to modifications in connection with the design Registration Statement, the Pricing Disclosure Package and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeProspectus, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable and, to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees best knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeand, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe research, 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 non-clinical and pre-clinical studies and clinical trials and tests conducted or being conducted by or on behalf of the Company or sponsored by any of its Subsidiaries or in which any of their respective product candidates have participated (collectively, the Company, with respect to the Company’s product candidates, including any such studies and trials “Studies”) that are described in the Prospectusin, or the results of which are referred to in in, the ProspectusRegistration Statement and the Prospectus were and, as applicable (collectively, “Company Trials”), were, and if still pending arepending, are being conducted in all material respects in accordance with the protocols, procedures and controls pursuant to all Applicable Lawsapplicable laws and Authorizations; the descriptions in the Prospectus each description of the results of any Company Trials are such Studies is accurate and complete descriptions in all material respects and fairly present presents the data derived therefrom; from such Studies, and the Company has and its Subsidiaries have no knowledge of any other research, non-clinical studies or trials not described in the Prospectus, tests the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and the Prospectus except as otherwise disclosed in the Registration Statement and the Prospectus; the Company is and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other United States or foreign government agency with jurisdiction over the types of products being developed by the Company 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 notice of, or correspondence from, any Governmental Authority requiring the termination, suspension or material modification of any Study; and the Company and its Subsidiaries have each operated and currently are in compliance in all material respects with all Applicable Laws; the Company has not receivedapplicable rules, nor does it have knowledge that any regulations and policies of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trialall Governmental Authorities. To the Company’s knowledge, none the manufacturing facilities and operations of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established its suppliers are operated in compliance in all material respects with all applicable laws 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)Authorizations.

Clinical Trials. 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 The preclinical tests and clinical trials conducted by or on behalf of or sponsored by the Company, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectusin, or the results of which are referred to in in, the ProspectusRegistration Statement, as applicable (collectivelythe Pricing Disclosure Package and the Prospectus were and, “Company Trials”), were, and if still pending arepending, are being conducted in all material respects in accordance with all Applicable Lawsprotocols filed with the appropriate regulatory authorities for each such test or trial, as the case may be, and with standard medical and scientific research procedures; the descriptions in the Prospectus each description of the results of any Company Trials are such tests and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus is accurate and complete descriptions in all material respects and fairly present presents in all material respects the data derived therefrom; from such tests and trials, and the Company has and its subsidiary have no knowledge of any other studies or trials not described in the Prospectus, tests the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; neither the Company is nor its subsidiary has received any notices or other correspondence from the Food and Drug Administration of the U.S. Department of Health and Human Services 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 the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and the Company and its subsidiary have each operated and currently are in compliance in all material respects with all Applicable Laws; the Company has not receivedapplicable rules, nor does it have knowledge that any regulations and policies of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)Agencies.

Clinical Trials. None The clinical and pre-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 Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the Company’s knowledge, all nonclinical descriptions in the Registration Statement or the Prospectus of the results of such studies and clinical trials conducted by are accurate and complete 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 on behalf otherwise call into question the results described or referred to in the Registration Statement and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; neither the Company, with respect nor any of its Subsidiaries, has not received any written notices, correspondence or other communication from the Regulatory Authorities or any governmental authority which could lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials there 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)reasonable grounds for same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe studies, 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 tests and preclinical and clinical trials conducted by or on behalf of of, or sponsored by by, the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, 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, as applicable (collectivelywere and, “Company Trials”), were, and if still pending arepending, are being conducted in all material respects in accordance with all Applicable Lawsapplicable medical and scientific research standards and protocols, procedures and controls and all applicable statutes, rules and regulations of the Regulatory Agencies, including, without limitation, 21 C.F.R. Parts 26, 50, 54, 56, 58, 99 and Subchapter H and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus 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 Company Trials are accurate misstatement of material fact or omit a material fact necessary to make such statements not misleading, and complete descriptions fairly present in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies studies, tests or trials not described in the Prospectus, Disclosure Package and the Prospectus the results of which are materially inconsistent with or reasonably 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 neither the Company is currently in compliance in all material respects with all Applicable Laws; the Company nor any subsidiary has not received, nor does it have knowledge that received any of its collaboration partners has received, any written notices, correspondence notices or other written communications correspondence from the any Regulatory Authorities Agency or any other governmental agency Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or suspension preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or any of its subsidiaries or in which the Company Trialsor any of its subsidiaries has participated, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical and pre-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 Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the Company’s knowledgedescriptions in the Registration Statement, all nonclinical the Disclosure Package or the Prospectus of the results of such studies and clinical trials conducted by are accurate and complete 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 on behalf otherwise call into question the results described or referred to in the Registration Statement, Disclosure Package and the Prospectus; the Company and its subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; neither the Company, with respect nor any of its subsidiaries, has not received any written notices, correspondence or other communication from the Regulatory Authorities or any governmental authority which could lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials there 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)reasonable grounds for same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the ProspectusRegistration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, as applicable (collectively, “Company Trials”), wereapplicable, and are intended to be submitted to Regulatory Authorities (as defined below) as a basis for product approval, were and, if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all Applicable Lawsapplicable statutes, rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the General Disclosure Package or the Final Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; the Company is and its subsidiaries have operated and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification termination or suspension of Company Trialsor material modification, other than ordinary course communications with respect modifications customarily implemented during the drug development process, of any clinical or pre-clinical trials that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus or the results of which are referred to modifications in connection with the design and implementation of such studies Registration Statement, General Disclosure Package or trials. The Company has obtained (or caused the Final Prospectus, and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)there are no reasonable grounds for same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe studies, 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 tests and preclinical and clinical trials conducted by or on behalf of of, or sponsored by by, the CompanyCompany or its subsidiary, with respect to or in which the Company’s product candidatesCompany or its subsidiary have participated, 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, as applicable (collectivelywere and, “Company Trials”), were, and if still pending arepending, are being conducted in all material respects in accordance with standard medical and scientific research standards and all Applicable Lawsapplicable statutes, rules and regulations of the applicable Regulatory Agencies and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Time of Sale Disclosure Statement and the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies studies, tests or trials not described in the Prospectus, Time of Sale Disclosure Package and the Prospectus the results of which are materially inconsistent with or reasonably 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 neither the Company is currently in compliance in all material respects with all Applicable Laws; the Company nor its subsidiary has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications notices from the any Regulatory Authorities Agency or any other governmental agency institutional review board requiring or threatening the termination, suspension or material modification of any studies, tests or suspension of preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company Trials, other than ordinary course communications with respect to modifications or in connection with which the design and implementation of such studies or trials. The Company has obtained (or caused participated, and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe clinical, 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 preclinical and nonclinical studies and clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable 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 “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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially 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 is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical, other than ordinary course communications with respect preclinical or nonclinical trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus or the results of which are referred to modifications in connection with the design Registration Statement, the Pricing Disclosure Package and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeProspectus, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable and, to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees best knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research procedures and all Applicable Lawsapplicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States 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 General Disclosure Package or the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration 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 studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The pre-clinical studies and clinical trials conducted by or or, to the knowledge of the Company and its subsidiaries, on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Prospectusin, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in accordance with protocols filed with the Prospectusappropriate regulatory authorities for each such study or trial, as the case may be, and with standard medical and scientific research standards and procedures, all applicable statutes, all applicable rules and regulations of the United States Food and Drug Administration (collectively, the “Company TrialsFDA”), werethe European Medicines Agency (the “EMA”), the Israel Ministry of Health (the “IMH”) and if still pending areother comparable regulatory agencies to which they are subject and Good Clinical Practices and Good Laboratory Practices, being conducted except to the extent where failure to conduct in all material respects such manner would not result in accordance with all Applicable Laws; the descriptions in the Prospectus a Material Adverse Change. Each description of the results of any Company Trials are such studies and trials contained in the Registration Statement or the Prospectus is accurate and complete descriptions in all material respects and fairly present presents the data derived therefrom; from such studies and trials, and the Company has or its subsidiaries have no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with with, or otherwise call into question question, the results described or referred to in the Registration Statement and the Prospectus; . 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 or the Prospectus. The Company is and its subsidiaries have operated at all times and currently are in compliance in all material respects with all Applicable Laws; the Company has not receivedapplicable statutes, nor does it have knowledge that any rules, regulations and policies of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)Agencies.

Clinical Trials. None of Except as described in the Company’s product candidates has received marketing approval from Registration Statement and the FDAProspectus, 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 clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the CompanyCompany or its Subsidiaries, with respect to or in which the Company’s product candidatesCompany or its Subsidiaries have participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Applicable Lawsapplicable statutes and all applicable rules and regulations of the FDA and comparable 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 any Company Trials such studies and tests 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 and the Prospectus, the results of which are materially inconsistent with or call into question in any material respect the results described or referred to in the Registration Statement and the Prospectus; the Company is and its Subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, Subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical trials and preclinical studies conducted by or, to the knowledge of the Company’s product candidates has received marketing approval from the FDACompany after due inquiry, 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 or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with all Applicable Lawsapplicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus of the results of any the clinical trials and preclinical studies conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company Trials or its subsidiaries contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials and studies; the Company has no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable LawsLaws of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical trials or preclinical studies that are described in the Registration Statement, the General Disclosure Package and the Prospectus or the results of which are referred to in the Registration 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 studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical trials and preclinical studies conducted by or, to the knowledge of the Company’s product candidates has received marketing approval from the FDACompany after due inquiry, 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 or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Lawsapplicable rules and regulations of the U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus of the results of any the clinical trials and preclinical studies conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company Trials or its subsidiaries contained in the Prospectus are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials and studies; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable laws of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical trials or preclinical studies that are described in the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable).

Clinical Trials. 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 i) The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company, with respect to or in which the Company’s product candidatesCompany has participated, including any such studies and trials that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Applicable Lawsapplicable statutes and all applicable rules and regulations of the FDA and comparable 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, as applicable; (ii) the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials 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 studies or trials not described in the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; (iv) the Company has operated at all times and is currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical and pre-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 Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the Company’s knowledgedescriptions in the Registration Statement, all nonclinical the Disclosure Package or the Prospectus of the results of such studies and clinical trials conducted by are accurate and complete 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 on behalf otherwise call into question the results described or referred to in the Registration Statement, Disclosure Package and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; neither the Company, with respect nor any of its Subsidiaries, has not received any written notices, correspondence or other communication from the Regulatory Authorities or any governmental authority which could lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials there 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)reasonable grounds for same.

Clinical Trials. None The clinical and pre-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 Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities and in certain cases serve as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the Company’s knowledge, all nonclinical descriptions in the Registration Statement or the Prospectus of the results of such studies and clinical trials conducted by 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 on behalf otherwise reasonably call into question the results described or referred to in the Registration Statement, and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance in all material respects with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; neither the Company, with respect nor any of its Subsidiaries, has received any written notices, correspondence or other written communication from the Regulatory Authorities or any governmental authority which could reasonably be expected to lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectivelyand, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)there are no reasonable grounds for same.

Clinical Trials. None The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company or its subsidiary, or in which the Company or its subsidiary have participated, that are described in the SEC Reports or the results of which are referred to in the SEC Reports were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules, regulations and policies of the Company’s product candidates has received marketing approval from U.S. Food and Drug Administration (the “FDA, the Israeli Ministry of Health or any ”) and comparable drug regulatory agency agencies 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 or sponsored by the Companyincluding, with respect to the Company’s product candidateswithout limitation, including any such studies and trials that are described in the Prospectus21 C.F.R. Parts 50, or the results of which are referred to in the Prospectus54, as applicable (collectively56, “Company Trials”), were58, and if still pending are312, being conducted in all material respects in accordance with all Applicable Lawsand current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus SEC Reports of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; from such trials and the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the ProspectusSEC Reports; the Company is and its subsidiary have operated and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules, regulations and policies of the Regulatory Authorities; and neither the Company has not received, nor does it its subsidiary have knowledge that received any of its collaboration partners has received, any written notices, correspondence or other written communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening which could lead to the termination, material modification termination or suspension of Company Trialsany clinical or pre-clinical trials that are described in the SEC Reports or the results of which are referred to in the SEC Reports and, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe clinical, 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 preclinical and nonclinical trials and studies and clinical trials conducted by or on behalf of or sponsored by the Company, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with their protocols and procedures and in material compliance with all Applicable Lawsapplicable 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 “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices (as defined by the FDA), as applicable; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly materially present the data derived therefromfrom such trials or studies; the Company has no knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany preclinical, other than ordinary course communications with respect clinical or nonclinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to modifications in connection with the design Registration Statement and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeProspectus, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable and, to the Company and its Subsidiaries, to assist knowledge of the Company, its Subsidiaries and their directors, officers and employees of there are no reasonable grounds for the Company and its Subsidiaries in complying with applicable regulatory guidelines same. (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicabless).

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the ProspectusRegistration Statement and the Prospects, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Applicable Lawsapplicable statutes and all applicable rules and regulations of the FDA and comparable regulatory agencies outside of the United States to which they are subject (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 any Company Trials such studies and tests 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 and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s best knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None of the Company’s product candidates has received marketing approval from the FDAThe clinical, 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 preclinical and nonclinical studies and clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable 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 “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical, other than ordinary course communications with respect preclinical or nonclinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to modifications in connection with the design Registration Statement and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeProspectus, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable and, to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees best knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, with respect to or in which the Company’s product candidatesCompany has participated, including any such studies and trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, were and, if still pending, are being conducted US-DOCS\95271282.8 in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Company TrialsRegulatory Authorities”), wereincluding, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312, and if still pending are, being conducted in all material respects in accordance with all Applicable Lawscurrent Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such studies and trials are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement and the Prospectus; the Company is and its subsidiaries have each operated and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; and neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written noticesnotice, correspondence or other written communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening authority which could lead to the termination, material modification termination or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)there are no reasonable grounds for same.

Clinical Trials. None The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Offering Memorandum or the results of which are referred to in the Offering Memorandum and which were submitted to Regulatory Authorities as a basis for product approval, were conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies 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 or sponsored by the Companyincluding, with respect to the Company’s product candidateswithout limitation, including any such studies and trials that are described in the Prospectus21 C.F.R. Parts 50, or the results of which are referred to in the Prospectus54, as applicable (collectively56, “Company Trials”), were58, and if still pending are312, being conducted in all material respects in accordance with all Applicable Lawsand current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus Offering Memorandum of the results of any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the ProspectusOffering Memorandum; the Company is and its subsidiaries have operated and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications communication from the Regulatory Authorities or any other governmental agency requiring or threatening which could lead to the termination, material modification termination or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Offering Memorandum or the results of which are referred to in the Offering Memorandum, other than ordinary course communications with respect and, to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)there are no reasonable grounds for same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for its investigational products or product candidates comparable to those being developed by the Company and all Applicable Lawsapplicable statutes and all applicable rules and regulations of the FDA and comparable 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 any Company Trials such studies and tests 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 and the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. 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 The preclinical tests and clinical trials conducted by or on behalf of or sponsored by the Company, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectusin, or the results of which are referred to in in, the Registration Statement, a Preliminary Prospectus, as applicable (collectivelythe Pricing Prospectus, “Company Trials”)the Prospectus or a Permitted Free Writing Prospectus, werewere and, and if still pending arepending, are being conducted in all material respects in accordance with all Applicable Lawsprotocols filed with the appropriate regulatory authorities for each such test or trial, as the case may be, and with standard clinical and scientific research procedures; the descriptions in the Prospectus description of the results of any Company Trials such tests and trials contained in the Registration Statement, a Preliminary Prospectus, the Pricing Prospectus, the Prospectus or a Permitted Free Writing Prospectus, are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; from such tests and trials, and the Company has and each of its subsidiaries have no knowledge of any other studies or trials not described in the Prospectus, tests the results of which are materially inconsistent with dispute, contradict or call into question show to be untrue the results described or referred to in the Registration Statement, a Preliminary Prospectus, the Pricing Prospectus, the Prospectus or a Permitted Free Writing Prospectus; except as previously disclosed to the Underwriters, neither the Company is nor any subsidiary has received any notices or other correspondence from the United States Food and Drug Administration (the “FDA”) or from any other U.S. or foreign government agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, a Preliminary Prospectus, the Pricing Prospectus, the Prospectus or a Permitted Free Writing Prospectus; and the Company and each subsidiary have each operated and currently are in compliance in all material respects with all Applicable Laws; the Company has not receivedapplicable rules, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design regulations and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none policies of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)FDA.

Clinical Trials. None The clinical trials and preclinical studies conducted by or, to the knowledge of the Company’s product candidates has received marketing approval from the FDACompany after due inquiry, 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 or sponsored by the Company, with respect to or in which the Company’s product candidatesCompany has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with all Applicable Lawsstandard industry practice and any applicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus of the results of any Company Trials such trials and studies contained in the Registration Statement or the Prospectus are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials and studies; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are materially inconsistent with or reasonably call into question the results described or referred to in the Registration Statement and the Prospectus; the Company has operated at all times and is currently in compliance in all material respects with all Applicable LawsLaws of the Regulatory Authorities; and the Company has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency with jurisdiction over it requiring or threatening the termination, material modification or suspension of Company Trialsany clinical trials or preclinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical trials and preclinical studies conducted by or, to the knowledge of the Company’s product candidates has received marketing approval from the FDACompany after due inquiry, 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 or sponsored by the CompanyCompany or its subsidiaries, with respect to or in which the Company’s product candidatesCompany or its subsidiaries have participated, including any such studies and trials that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Lawsapplicable rules and regulations of the U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus of the results of any the clinical trials and preclinical studies conducted on the Company’s product candidates or conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company Trials or its subsidiaries contained in the Prospectus are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials and studies; the Company has no knowledge of any other studies or trials not described in the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is and its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable laws of the Regulatory Authorities; except as disclosed in the Prospectus, neither the Company has not received, nor does it have knowledge that any of its collaboration partners has received, subsidiaries have received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical trials or preclinical studies that are described in the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable).

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; the Company is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeand, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable).same. ​ ​

Clinical Trials. None The clinical and pre-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 Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are, except as would not individually or in the aggregate have a Material Adverse Effect, being conducted in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the Company’s product candidates has received marketing approval from the FDA, the Israeli Ministry of Health or any FDA and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the Company’s knowledge, all nonclinical descriptions in the Registration Statement or the Prospectus of the results of such studies and clinical trials conducted by are accurate and, in all material respects, complete 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 on behalf otherwise call into question the results described or referred to in the Registration Statement and the Prospectus; the Company and its Subsidiaries have each operated and are currently in compliance, in all material respects, with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; and neither the Company, with respect nor any of its Subsidiaries, has not received any written notices, correspondence or other communication from the Regulatory Authorities or any governmental authority which could lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials there 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)reasonable grounds for same.

Clinical Trials. 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 The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures and all Applicable Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (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 any Company Trials such studies and tests are accurate and complete descriptions in all material respects and fairly present the data derived therefromfrom such trials; neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially 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 is and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement, other than ordinary course communications with respect the Pricing Disclosure Package and the Prospectus or the results of which are referred to modifications in connection with the design Registration Statement, the Pricing Disclosure Package and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeProspectus, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. The Company has established and administers a compliance program applicable and, to the Company and its Subsidiaries, to assist the Company, its Subsidiaries and their directors, officers and employees knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or, to the Company’s knowledge, in which the Company has participated, that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined herein) as a basis for product candidates has received marketing approval from approval, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the FDA, the Israeli Ministry of Health or any United States Food and Drug Administration and comparable drug regulatory agency agencies outside of the United States or Israel to which it is subject (collectively, the “Regulatory Authorities”). To , including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the Company’s knowledgedescriptions in the Registration Statement, all nonclinical or the Prospectus of the results of such studies and clinical trials conducted by 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 in any material respect with or on behalf otherwise call into question the results described or referred to in the Registration Statement, and the Prospectus; the Company and its subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of or sponsored by the Regulatory Authorities; neither the Company, with respect nor any of its subsidiaries, has received any written notices, correspondence or other written communication from the Regulatory Authorities or any governmental authority which could lead to the Company’s product candidates, including termination or suspension of any such studies and clinical or pre-clinical trials that are described in the Prospectus, Prospectus or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with all Applicable Laws; the descriptions in the Prospectus of the results of any Company Trials there 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 Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Prospectus; the Company is currently in compliance in all material respects with all Applicable Laws; the Company has not received, nor does it have knowledge that any of its collaboration partners has received, any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)reasonable grounds for same.

Clinical Trials. None of (1) 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 clinical and pre-clinical trials conducted by or on behalf of or sponsored by the CompanyCompany or any of its subsidiaries, with respect to or in which the Company’s product candidatesCompany or any of its subsidiaries has participated, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in accordance in all material respects in accordance with standard medical and scientific research standards and all Applicable Lawsapplicable statutes, rules and regulations of the FDA and other applicable regulatory authorities (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices; (2) the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such studies and tests are accurate and complete descriptions and fairly present in all material respects and fairly present the data derived therefromfrom such trials; (3) neither the Company nor any of its subsidiaries has no any knowledge of any other studies or trials not described in the Prospectustrials, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement or the Prospectus; (4) the Company is and each of its subsidiaries are currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; and (5) neither the Company has not received, nor does it have knowledge that any of its collaboration partners subsidiaries has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical or pre-clinical trials that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledgeand, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 knowledge of the Company and its Subsidiaries in complying with applicable regulatory guidelines (includingsubsidiaries, without limitation, those administered by there are no reasonable grounds for the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.

Clinical Trials. None (i) The clinical trials and pre-clinical research and development activities conducted by or, to the knowledge 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 or sponsored by the Company, with respect to or in which the Company’s product candidatesCompany has participated, including any such studies and trials that are described in the Prospectus, or the results of which are referred to in the Prospectus, as applicable (collectively, “Company Trials”)applicable, were, and if still pending are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all Applicable Lawsapplicable statutes and all applicable rules and regulations of the FDA and comparable 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, as applicable; (ii) the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials such trials and pre-clinical research and development activities 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 studies or Company-sponsored trials and research and development activities not described in the Prospectus, the results of which are materially inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; (iv) the Company has operated at all times and is currently in compliance in all material respects with all Applicable Lawsapplicable statutes, rules and regulations of the Regulatory Authorities; and (v) except as described in the Prospectus, the Company has not received, nor does it have knowledge that any of its collaboration partners has received, received any written notices, correspondence or other written communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trialsany clinical trials or pre-clinical research and development activities that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials. The Company has obtained (or caused , and, to be obtained) the informed consent of each human subject who participated in a Company Trial. To the Company’s knowledge, none of there are no reasonable grounds for the Company Trials involved any investigator who has been disqualified as a clinical investigator. 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 complying with applicable regulatory guidelines (including, without limitation, those administered by the FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA to the extent applicable)same.