Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials being conducted or sponsored by the Company Company, and, to the knowledge of the Company, other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, areare being conducted, to the Company’s knowledge, being conducted in all material respects respects, in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete complete, in all material respects in the context of the experimental set-up respects, and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required for the conduct of the studies by the Israeli Ministry of Health, 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. U.S., Israeli or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance compliance, in all material respects respects, with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the trade, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals or authorizations as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus SEC Documents were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies studies, and with standard medical all applicable Health Care Laws (as defined below), including, but not limited to, the Federal Food, Drug and scientific research proceduresCosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectivelyBoard; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the “Regulatory Agencies”) for FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the operation knowledge of the Company’s business as currently conducted, except as could not threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be expected, individually conducted by or in the aggregate, to have a Material Adverse Effect; neither on behalf of the Company nor or any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectus and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies studies, and with standard medical all applicable Health Care Laws (as defined below), including, but not limited to, the Federal Food, Drug and scientific research proceduresCosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectivelyBoard; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the “Regulatory Agencies”) for FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the operation knowledge of the Company’s business as currently conducted, except as could not threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be expected, individually conducted by or in the aggregate, to have a Material Adverse Effect; neither on behalf of the Company nor or any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company (collectively, “Company studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Company studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such Company studies within the limits of interpretation by people trained and, except as disclosed in the tradeRegistration Statement, the Time of Sale Prospectus and the Prospectus, the Company and its subsidiaries have no knowledge of any other Company studies or third-party studies the results of which are inconsistent in any material respect with, or otherwise call into questionquestion in any material respect, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Prospectuses and the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for in order to conduct the operation business of the Company’s business Company and its subsidiaries as currently presently conducted, except as could not be expected, individually or described in the aggregateRegistration Statement, to have a Material Adverse Effectthe Time of Sale Prospectus or the Prospectus; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, conducted by or on behalf of or sponsored by the results Company or any of its subsidiaries or in which are referred to in, the Registration Statement, the Time Company or any of Sale Prospectus its subsidiaries or the Prospectus their products or product candidates have participated were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable laws and scientific research proceduresregulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the U.S. Food and Drug Administration (“FDA”) has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries; the Company and its subsidiaries have made all such filings and obtained hold all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus); and the Company and its subsidiaries have each operated fulfilled and currently are performed all of their material obligations with respect to such Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in compliance in all any other material respects with all applicable rules and regulations impairment of the Regulatory Agencies, except as could not be expected, individually or in rights of the aggregate, to have a Material Adverse Effectholder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company (collectively, “studiesStudies”) being conducted by or, to the knowledge of the Company for the Company or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pendingbeing conducted, are, to the Company’s knowledge, are being or were conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act, 21 U.S.C. (the “FDCA”) and the regulations promulgated thereunder, the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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. federal, state or local, or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials Studies currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable local, state, and scientific research proceduresfederal laws, rules, and regulations, including, without limitation, the Federal Food, Drug, and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws including, without limitation, the Federal Food, Drug, and Cosmetic Act and the implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals approvals, permits, licenses, exemptions, clearances or authorizations (“Regulatory Permits”) as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such Regulatory Permit would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; except as described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by the Company or its subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, and with respect to those studies not conducted by the Company or its subsidiaries are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies studies, and with standard medical all applicable Health Care Laws (as defined below), including, but not limited to, the Federal Food, Drug and scientific research proceduresCosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration (the “FDA”) 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, or health care facility Institutional Review Board (collectivelyinstitutional review board; no investigational new drug application filed by or on behalf of the Company or its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the “Regulatory Agencies”) for FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the operation knowledge of the Company’s business as currently conducted, except as could not threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be expected, individually conducted by or in the aggregate, to have a Material Adverse Effect; neither on behalf of the Company nor or any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to or incorporated by reference in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to or incorporated by reference in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for except where the operation of the Company’s business as currently conducted, except as failure to make such filing or obtain such approval could not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, conducted by or on behalf of or sponsored by the results Company or any of its subsidiaries or in which are referred to in, the Registration Statement, the Time Company or any of Sale Prospectus its subsidiaries or the Prospectus their products or product candidates have participated were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable laws and scientific research proceduresregulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the U.S. Food and Drug Administration (“FDA”) has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries; the Company and its subsidiaries have made all such filings and obtained hold all such approvals Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus); and the Company and its subsidiaries have each operated fulfilled and currently are performed all of their material obligations with respect to such Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in compliance in all any other material respects with all applicable rules and regulations impairment of the Regulatory Agencies, except as could not be expected, individually or in rights of the aggregate, to have a Material Adverse Effectholder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials being conducted or sponsored by the Company and its subsidiaries, and, to the knowledge of the Company, other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus SEC Documents were and, if still pending, areare being conducted, to the Company’s knowledge, being conducted in all material respects respects, in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete complete, in all material respects in the context of the experimental set-up respects, and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required for the conduct of the studies by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Documents; and the Company and its subsidiaries have each operated and currently are in compliance compliance, in all material respects respects, with all applicable rules laws, rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, and with respect to those studies not conducted by the Company are to the Company’s knowledge, being conducted in all material respects in accordance with standard medical and scientific research procedures, the protocols, procedures and controls designed and approved for such studies studies, and with standard medical all applicable Health Care Laws (as defined below), including, but not limited to, the Federal Food, Drug and scientific research proceduresCosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration (the “FDA”) 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, or health care facility Institutional Review Board (collectivelyBoard; no investigational new drug application filed by or on behalf of the Company with the FDA has been terminated or suspended by the FDA, and neither the “Regulatory Agencies”) for FDA nor any applicable foreign governmental or regulatory authority or agency has commenced, or, to the operation knowledge of the Company’s business as currently conducted, except as could not threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be expected, individually conducted by or in the aggregate, to have a Material Adverse Effect; neither on behalf of the Company nor or any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable Health Care Laws, except where the protocolsfailure to be so conducted would not be expected, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresindividually or in the aggregate, to result in a Material Adverse Change; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the traderespects, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise materially call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the ProspectusProspectus when viewed in the context in which such results are described and the clinical state of development; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for except where the operation of the Company’s business as currently conducted, except as could failure to make such filings or obtain such approvals would not be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange; and neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not Prospectus which would be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. (i) The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; (ii) each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect; (iv) neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The research, preclinical tests and clinical trials, and tests conducted or being conducted by or on behalf of the Company or any of its Subsidiaries or in which any of their respective product candidates have participated and, to the Company’s knowledge, the preclinical studies and clinical trials conducted directed or sponsored by the Company Company’s collaborators (collectively, “studiesStudies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) except for the operation of the Company’s business as currently conducted, except as could not be expectedsuch failures that, individually or in the aggregate, would not reasonably be expected to have result in a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. There have been no material serious adverse events resulting from any Study. To the Company’s knowledge, except as could not be expected, individually or the manufacturing facilities and operations of its suppliers are operated in the aggregate, to have a Material Adverse Effectcompliance in all material respects with all applicable laws and governmental permits.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, to conduct such studies; except as could not be expected, individually or disclosed in the aggregateRegistration Statement, to have a Material Adverse Effect; the Pricing Disclosure Package or the Prospectus, neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for except where the operation of the Company’s business as currently conducted, except as failure to make such filing or obtain such approval could not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals or authorizations as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Disclosure Package or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials and other studies conducted or sponsored being conducted by or at the direction of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical all applicable local, state and scientific research proceduresfederal laws, rules and regulations, including the Federal Food, Drug, and Cosmetic Act and its implementing regulations; each description in the Registration Statement, the Time of Sale Prospectus and the Prospectus of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeall material respects, and to the Company and its subsidiaries have Company’s knowledge, there are no knowledge of any other studies the results of which are materially inconsistent with, with or otherwise call into question, question in any material respect the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses, or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals Permits as may be required to be made or obtained by the Company by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from by any other applicable U.S. or foreign government or governmental drug or medical device regulatory agency, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make any such filing or obtain any such Permit would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect; neither other than as described in the Registration Statement, the Time of Sale Prospectus or the Prospectus, the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring requiring, and, to the knowledge of the Company, no Regulatory Agency has threatened to initiate, the termination, suspension or material modification of any clinical trials conducted or being conducted by or at the direction of the Company that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, to the knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries subsidiary have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries subsidiary have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries subsidiary has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries subsidiary have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by or sponsored by on behalf of the Company (collectively, “studies”) or its subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus (collectively, “Studies”), were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical all applicable laws and scientific research proceduresregulations, including, without limitation the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312; each such description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies with respect to the Company’s product candidates not described in the Registration Statement, the Time of Sale Prospectus or the Prospectus the results of which are inconsistent with, or otherwise reasonably call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained obtained, and are operating in material compliance with, all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for in connection with the operation Studies; no investigational new drug application filed by or on behalf of the Company or its subsidiaries with the Food and Drug Administration has been terminated or suspended by the Food and Drug Exhibit 1.1 Administration, and neither the Food and Drug Administration nor any other Regulatory Agency has commenced, or to the knowledge of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, threatened to have initiate any action to place a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice ofclinical hold order on, or correspondence from, any Regulatory Agency requiring otherwise require the termination, suspension or modification of any clinical trials that are described Studies conducted, proposed to be conducted, or referred to in the Registration Statementcurrently being conducted, the Time by or on behalf of Sale Prospectus or the Prospectus; and the Company and or its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effectsubsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted or sponsored by that are described in the Company Registration Statement and Prospectus (collectively, “studiesStudies”) that are described inwere conducted by or, to the knowledge of the Company, on behalf of the Company or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus its subsidiaries were and, if still pendingongoing, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and pursuant to, where applicable, accepted professional scientific research proceduresstandards; each description the descriptions of the results of such studies is reasonably contained in the Registration Statement and Prospectus are accurate and complete in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained Studies, in the tradeeach case in all material respects, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Statement and Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has have received any notice offrom, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described Studies conducted by or referred to on behalf of the Company or its subsidiaries, except as disclosed in the Registration Statement, the Time of Sale Prospectus or Statement and the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company (collectivelyCompany, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus Supplement were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusProspectus Supplement; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusProspectus Supplement; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, Agencies except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company and its Subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus 2024 Q2 Form 10-Q were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the 2023 Form 10-K and 2024 Q2 Form 10-Q. The Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by 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 agencyDrug Regulatory Agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the 2023 Form 10-K and 2024 Q2 Form 10-Q, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither . Neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement2023 Form 10-K and 2024 Q2 Form 10-Q, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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 agencyagency (including any U.S. state departments of health and boards of pharmacy), or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement, the Time of Sale Prospectuses and the Prospectus, except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company trials, (collectively, “studiesStudies”) that are described in, or the results of which are described or referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries Subsidiaries are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its Subsidiaries including, but not limited to those for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., and the amendments thereto (the “Applicable Laws”). The Company and its Subsidiaries have made all such filings and obtained all such approvals as may be required by the U.S. Food and Drug Administration of the U.S. Department of Health (“FDA”) and Human Services or any committee thereof or from any other U.S. federal, state, local or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board authority with jurisdiction over the products being developed by the Company and its Subsidiaries (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules Applicable laws, rules, and regulations of the Regulatory Agencies. The Company and its Subsidiaries, except as could are and have been in compliance with all statutes, laws, ordinances, rules and regulations applicable to the operation and business of the Company and its Subsidiaries including, but not be expectedlimited to those for the ownership, individually testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the amendments thereto and the regulations promulgated thereunder, in all material respects. Neither the aggregateCompany nor its Subsidiaries have received any written notice of adverse finding, warning letter or other written correspondence or notice from the FDA or any other governmental entity alleging or asserting noncompliance with any Applicable Laws; the Company has not received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any product, operation or activity is in violation of any Applicable Laws or has any knowledge that any such governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, nor, to the best of the Company’s knowledge, has there been any noncompliance with or violation of any Applicable Laws by the Company or its Subsidiaries that could reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity; neither the Company nor its Subsidiaries has received written notice that any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits or has any knowledge that any such governmental entity has threatened or is considering such action; and the Company and its Subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable laws and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a Material Adverse Effectsubsequent submission), in all material respects. Neither the Company, its Subsidiaries and, to the Company’s knowledge, any of its directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company and other studies (collectively, “studiesStudies”) conducted by or on behalf of the Company or its subsidiaries, or in which the Company’s product candidates have participated, including those that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects with applicable laws, including, without limitation, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) and the rules and regulations promulgated thereunder and any applicable statutes, rules, regulations and policies of the jurisdictions in accordance with the protocols, procedures and controls designed and approved for which such studies and with standard medical and scientific research proceduresStudies are being conducted; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals or authorizations as may be required by the Food and Drug Administration (the “FDA”) 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, or health care facility Institutional Review Board agency (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filing or obtain such approval would not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effectmaterial adverse effect on the Company and its subsidiaries, taken as a whole; and except as described in the Registration Statement and the Prospectus, neither the Company nor any of its subsidiaries has have received any notice of, or correspondence from, any Regulatory Agency or health care facility Institutional Review Board requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and , nor is the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations aware of the Regulatory Agencies, except as could not be expected, individually any reasonable grounds for such notice or in the aggregate, to have a Material Adverse Effectcorrespondence.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company and its subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus 2022 SEC Reports were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the 2022 SEC Reports. The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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 agencyDrug Regulatory Agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the 2022 SEC Reports, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither . Neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement2022 SEC Reports, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Israeli Ministry of Health, 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. U.S., Israeli or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where the failure to make such filings or obtain such approvals would not be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests nonclinical studies and clinical trials conducted or sponsored by the Company (collectively, “studiesStudies”) being conducted by or, to the knowledge of the Company for the Company or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pendingbeing conducted, are, to the Company’s knowledge, are being or were conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act, 21 U.S.C. (the “FDCA”), the Public Health Service Act, 42 U.S.C. Section 262 (the “PHSA”) and the regulations promulgated thereunder, the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and scientific research procedures; each description of the results of such studies Studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents presents, in all material respects, the data derived from such studies within the limits of interpretation by people trained in the tradeStudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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. federal, state or local, or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the Registration Statement and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials Studies currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is reasonably is, to the Company’s knowledge, accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed and approved for such studies and with standard medical and scientific research proceduresapplicable laws; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the Company would reasonably expect to contradict the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its current business as currently conducteddescribed in the Registration Statement and the Prospectus, except as could where the failure to do so would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations laws of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or Document and the Prospectus Final Offering Memorandum were and, if still pending, are, to the Company’s knowledge, are being conducted (x) in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act (“FFDCA”) and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, and (y) except where the failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, with the protocols, procedures and controls designed and approved for such studies and studies, with standard medical and scientific research procedures, and (y) where applicable, with accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries Subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or Document and the ProspectusFinal Offering Memorandum; the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials studies that are described or referred to in the Registration Statement, the Time of Sale Prospectus or Document and the ProspectusFinal Offering Memorandum and, to the Company’s knowledge, there are no reasonable grounds for the same; and the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. Except as disclosed in the Time of Sale Document and the Final Offering Memorandum, except as could the Company has not be expectedmade any knowingly false statements on, individually or omissions from, any applications, approvals, reports or other submissions to any Regulatory Agencies, or in or from any other records and documentation prepared or maintained to comply with the aggregaterequirements of any Regulatory Agencies relating to the Company’s approved products, tentatively approved product, or product candidates. Except as disclosed in the Time of Sale Document and the Final Offering Memorandum, neither the Company nor, to have a Material Adverse Effectthe knowledge of the Company, any officer, key employee or agent of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (a) debarment under 21 USC Section 335a or any similar state or foreign law or regulation and neither the Company nor any such person has been so debarred or excluded.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is reasonably is, to the Company’s knowledge, accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses, the Prospectus or the Canadian Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to or incorporated by reference in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could where such failure or non-compliance would not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to or incorporated by reference in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, ); except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect, for the conduct of its business as described in the Registration Statement, the Pricing Prospectuses and the Prospectus; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in 218136659 v11 compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is reasonably is, to the Company’s knowledge, accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the ProspectusProspectus when viewed in the context in which such results are described and the clinical stage of development; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be expectedwhere the failure to do so would not, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse EffectChange; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials conducted that are described in the Registration Statement or sponsored by the Company Prospectus (collectively, “studiesStudies”) that are described inwere conducted by or, to the knowledge of the Company, on behalf of the Company or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus its subsidiaries were and, if still pendingongoing, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and with standard medical and pursuant to, where applicable, accepted professional scientific research proceduresstandards; each description the descriptions of the results of such studies is reasonably contained in the Registration Statement or the Prospectus are accurate and complete descriptions in all material respects in the context of the experimental set-up and fairly presents present the data derived from such studies within the limits of interpretation by people trained Studies, in the tradeeach case in all material respects, and the Company and its subsidiaries have no knowledge of any other studies Studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services FDA or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be expectedwould not, individually or in the aggregate, reasonably be expected to have result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has have received any notice offrom, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described Studies conducted by or referred to in on behalf of the Registration Statement, the Time of Sale Prospectus Company or the Prospectusits subsidiaries; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) being conducted by or, for the Company, or that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, ); except as could not be reasonably expected, individually or in the aggregate, aggregate to have a Material Adverse Effect, for the conduct of its business as described in the Registration Statement, the Time of Sale Prospectuses and the Prospectus; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials currently being conducted or proposed to be conducted by or for the Company, that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company and its subsidiaries that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus 2023 Form 10-K were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed applicable laws and approved for such studies and with standard medical and scientific research proceduresregulations; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which the Company reasonably believes are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the 2023 Form 10-K. The Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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 agencyDrug Regulatory Agency, or health care facility Institutional Review Board Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the operation conduct of the Company’s its business as currently conducteddescribed in the 2023 Form 10-K, except as could where the failure to do so would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect; neither . Neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement2023 Form 10-K, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies. For purposes of this paragraph (except the final clause of the immediately preceding sentence), except the Company and its subsidiaries shall be deemed to refer to (1) Legacy Tourmaline and its subsidiaries as could not be expected, individually or in they existed prior to the aggregate, to have a Material Adverse EffectMerger Closing Date and (2) the Company and its subsidiaries solely from and after the Merger Closing Date.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus were and, if still pending, are, to the Company’s knowledge, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresstudies; each description of the results of such studies is reasonably to the Company’s knowledge accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses, the Prospectus or the Canadian Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as could not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus, the Prospectus or the Canadian Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge as of the date hereof of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Pricing Prospectuses or the Prospectus; the Company and its subsidiaries have has made all such filings and obtained all such approvals as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted), except as where the failure to make such filing or obtain such approval could not reasonably be expectedexpected to, individually or in the aggregate, to have result in a Material Adverse Effect; neither except such as are described in the Registration Statement, the Pricing Prospectus and the Prospectus, the Company nor any of its subsidiaries has not received any written notice of, or correspondence from, any Regulatory Agency requiring the termination, termination or suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Pricing Prospectus or the Prospectus; and the Company and its subsidiaries have each has operated and currently are is in compliance in all material respects with all applicable rules rules, regulations and regulations policies of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials trials, and other studies conducted by or sponsored by on behalf of the Company (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus General Disclosure Package or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and and, where applicable, with standard medical and scientific research proceduresprocedures and all applicable laws including, without limitation, the Federal Food, Drug, and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have has no knowledge of any other studies studies, the results of which are inconsistent with, or otherwise call into question, would cause the results described or referred to in the Registration Statement, the Time of Sale Prospectus General Disclosure Package or the ProspectusProspectus to be misleading; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, with respect to have a Material Adverse Effectsuch studies; neither the Company nor any of and its subsidiaries has have not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials conducted by or on behalf of the Company that are described or referred to in the Registration Statement, the Time of Sale Prospectus General Disclosure Package or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all Prospectus which termination, suspension or material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not modification would reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials conducted or sponsored by or on behalf of the Company Company, and, to the knowledge of the Company, other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are, to the Company’s knowledge, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research proceduresprocedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is reasonably accurate and complete in all material respects in the context of the experimental set-up and fairly presents the data derived from such studies within the limits of interpretation by people trained in the tradestudies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectus Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals Permits as may be required by 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, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect); and neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies, except as could not be expected, individually or in the aggregate, to have a Material Adverse Effect.