Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 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 hold all such 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”); and the Company and its subsidiaries have fulfilled and 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 any other material impairment of the rights of the holder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 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 hold all such 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”); and the Company and its subsidiaries have fulfilled and 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 any other material impairment of the rights of the holder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by that are described in, or on behalf the results of which are referred to in, the Registration Statement or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and all applicable laws with standard medical and regulationsscientific research procedures, includingexcept where the failure to do so has not resulted and would not reasonably be expected to, without limitationsingly or in the aggregate, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812result in a Material Adverse Effect; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 Prospectuses Statement 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 hold obtained all such Permits 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 as would not, singly or in the aggregate, have or 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 or the Prospectus; and the Company and its subsidiaries have fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permitsall applicable rules, regulations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment policies of the rights of the holder of any such PermitRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by or on behalf of or sponsored by the Company or any of its subsidiaries that are described in, or in the results of which are referred to in, the Company Registration Statement, the Time of Sale Prospectus or any of its subsidiaries or their products or product candidates have participated 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 all applicable laws and regulationsHealth Care Laws (as defined below), including, without limitationbut not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 58 and 812312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 Prospectuses 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; 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”) FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign governmental or regulatory authority or 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 clinical investigation 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 hold all such 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”); and the Company and its subsidiaries have fulfilled and 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 any other material impairment of the rights of the holder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by that are described in, or on behalf the results of which are referred to in, the Registration Statement or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the protocolsFood and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, procedures and controls designed and approved for such studies and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studiesrespects, 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 Prospectuses Statement or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such material filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and 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”) 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 hold all such 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”); and the Company and its subsidiaries have fulfilled and 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 any other material impairment of the rights of the holder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted that are described in, or the results of which are referred to in, the Company’s periodic reports on Forms 10-K and 10-Q and current reports of Form 8-K filed by or on behalf of or sponsored by it with the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated were andSEC, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and all applicable laws with standard medical and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 Company’s periodic reports on Forms 10-K and 10-Q and current reports of Sale Prospectuses or the Prospectus; no investigational new drug application Form 8-K filed by or on behalf of the Company or any of its subsidiaries it 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 subsidiariesSEC; the Company and its subsidiaries Subsidiaries have made all such filings and hold obtained all such Permits approvals certificates, authorizations and 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 or other regulatory authority having jurisdiction over the conduct of their business (collectively, the “Regulatory Agencies”); 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 Company’s periodic reports on Forms 10-K and 10-Q and current reports of Form 8-K filed by it with the SEC; and the Company and its subsidiaries Subsidiaries have fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permitsall applicable rules, regulations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment policies of the rights of the holder of any such PermitRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by or or, to the Company’s knowledge, on behalf of or sponsored by the Company that are described in, or any the results of its subsidiaries which are referred to in, the Registration Statement, the Time of Sale Prospectus or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies studies, and all applicable laws with standard medical and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and presents fairly presents the data derived from such studies, and the Company and its subsidiaries have no actual 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 Prospectus 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 hold obtained all such Permits 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”); 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 fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permitsall applicable rules, regulations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment policies of the rights of the holder of any such PermitRegulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) conducted by that are described in, or on behalf the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and all applicable laws with standard medical and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 Prospectuses Prospectus 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 hold obtained all such Permits 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”); 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 fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permitsall applicable rules, regulations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment policies of the rights Regulatory Agencies. For purposes of this paragraph (except the final clause of the holder of any such Permitimmediately preceding sentence), the Company and its subsidiaries shall be deemed to refer to (1) Legacy Tourmaline and its subsidiaries as they existed prior to the Merger 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, and other studies (collectively, “studies”) conducted by that are described in, or on behalf the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the protocolsFood and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, procedures and controls designed and approved for such studies and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studiesrespects, 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 Prospectuses or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such material filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and 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”) 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 terminate 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 hold all such 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”); and the Company and its subsidiaries have fulfilled and 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 any other material impairment of the rights of the holder of any such Permit.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”) trials conducted by or on behalf of or sponsored by the Company or any of its subsidiaries that are described in, or in the results of which are referred to in, the Company Registration Statement, the Time of Sale Prospectus or any of its subsidiaries or their products or product candidates have participated the Prospectus (collectively, “Studies”), were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Studies and all applicable laws and regulations, including, without limitationlimitation the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812312; each such description of the results of such studies Studies is accurate and complete in all material respects and fairly presents the data derived from such studiesStudies, 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 Prospectuses Prospectus 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 hold obtained, and are operating in material compliance with, all such 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”)) in connection with the Studies; and no investigational new drug application filed by or on behalf of the Company and or its subsidiaries have fulfilled with the Food and performed all of their material obligations with respect to such PermitsDrug Administration has been terminated or suspended by the Food and Drug Exhibit 1.1 Administration, and no event neither the Food and Drug Administration nor any other Regulatory Agency has occurred which allowscommenced, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment to the knowledge of the rights Company, threatened to initiate any action to place a clinical hold order on, or otherwise require the termination, suspension or modification of any Studies conducted, proposed to be conducted, or currently being conducted, by or on behalf of the holder of any such PermitCompany or its subsidiaries.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies (collectively, “studies”) conducted or being conducted by or on behalf of the Company or any subsidiary of the Company (collectively, “Company Studies”) and, to the Company’s knowledge, the preclinical studies and clinical trials, and other studies directed or sponsored by the Company Company’s collaborators (collectively, “Collaborator Studies”) that are described in, or any the results of its subsidiaries which are referred to in, the Registration Statement, the Time of Sale Prospectus or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Company Studies and all applicable laws Collaborator Studies and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 with standard medical and 812scientific research procedures; each description of the results of such studies Company Studies and, to the Company’s knowledge, such Collaborator Studies is accurate and complete in all material respects and fairly presents the data derived from such studiesCompany Studies and Collaborator Studies, and the Company and its subsidiaries have no knowledge of any other studies Company Studies and Collaborator 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 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 hold obtained all such Permits approvals as may be required by the United States Food and Drug Administration of and the U.S. Department of Health and Human Services or any committee thereof European Medicines Agency or from any other U.S. similar United States or foreign government governmental authority having jurisdiction over the Company, its business or drug or medical device regulatory agency, or health care facility Institutional Review Board its activities (collectively, the “Regulatory Agencies”); except as described in the Registration Statement, the 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 Company Study and Collaborator Study; and the Company and its subsidiaries have fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permits, all applicable rules and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment regulations of the rights Regulatory Agencies (it being understood that the Company has no control over the design, progress, timing, resources or conduct of the holder of any such PermitCollaborator Studies).

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by or on behalf of or sponsored by the Company or any of and its subsidiaries that are described in, or in the results of which are referred to in, the Company or any of its subsidiaries or their products or product candidates have participated 2023 Form 10-K were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures approved protocols and controls designed and approved for such studies and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, 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 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 2023 Form 10-K. The Company and its subsidiaries have made all such filings and hold obtained all such Permits 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 conduct of its business as described in the 2023 Form 10-K, except where the failure to do so would not 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 or suspension of any clinical trials that are described or referred to in the 2023 Form 10-K, and the Company and its subsidiaries have fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permits, all applicable rules and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment regulations of the rights of Regulatory Agencies, except where any noncompliance with such rules and regulations would not reasonably be expected, individually or in the holder of any such Permitaggregate, to have a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies (collectively, “studies”) conducted or being conducted by or on behalf of the Company or any subsidiary of the Company (collectively, “Company Studies”) and, to the Company’s knowledge, the preclinical studies and clinical trials, and other studies directed or sponsored by the Company Company’s collaborators (collectively, “Collaborator Studies”) that are described in, or any the results of its subsidiaries which are referred to in, the Registration Statement, the Time of Sale Prospectus or in which the Company or any of its subsidiaries or their products or product candidates have participated Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies Company Studies and all applicable laws Collaborator Studies and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312 with standard medical and 812scientific research procedures; each description of the results of such studies Company Studies and, to the Company’s knowledge, such Collaborator Studies is accurate and complete in all material respects and fairly presents the data derived from such studiesCompany Studies and Collaborator Studies, and the Company and its subsidiaries have no knowledge of any other studies Company Studies and Collaborator 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 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 hold obtained all such Permits approvals as may be required by the European Medicines Agency, the Food and Drug Administration of the U.S. United States Department of Health and Human Services or any committee thereof or from any other U.S. United States or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); except as described in the Registration Statement, the 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 Company Study and Collaborator Study; and the Company and its subsidiaries have fulfilled each operated and performed currently are in compliance in all of their material obligations respects with respect to such Permitsall applicable rules, regulations and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment policies of the rights Regulatory Agencies (it being understood that the Company has no control over the design, progress, timing, resources or conduct of the holder of any such PermitCollaborator Studies).

Clinical Data and Regulatory Compliance. The preclinical studies and tests and clinical trials, investigations and other studies (collectively, “studies”) that have been or are being conducted or sponsored by or on behalf of or sponsored by the Company or any of its subsidiaries or in which the Company or any of its subsidiaries or their Company’s products or product candidates have participated (collectively, “Studies”) were and, if still pending, are being conducted in all material respects in accordance with all Health Care Laws (defined below) and Authorizations (defined below), and the protocols, procedures and controls designed and approved for such studies and all applicable laws with standard medical and regulationsscientific research procedures, including, without limitation, limitation 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812; each description . The descriptions of the Studies, and the results thereof, contained in the Registration Statement, the Time of such studies is Sale Prospectuses and the Prospectus are accurate and complete in all material respects and fairly presents present the data derived from such studies, 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 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 hold obtained all such approvals and 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 or ethics committee (collectively, the “Regulatory Agencies”); and neither the Company and nor any of its subsidiaries have fulfilled and performed all of their material obligations with respect to such Permits, and no event has occurred which allowsreceived any notice of, or after notice correspondence from, any Regulatory Agency or lapse of time would allow, revocation or termination thereof or results in any other material impairment of federal, state, local or foreign or governmental regulatory authority requiring the rights of the holder termination, suspension or modification of any such PermitStudies.