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 used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols approved for such studies and with applicable statutes and regulations promulgated by the U.S. Food and Drug Administration (“FDA”); 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (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 or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) conducted by or on behalf of or sponsored 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies, except for such noncompliance that would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Change.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical trials, trials and other studies used to support regulatory approval (collectively, “studiesStudies”) 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 SEC Reports were (and, if still pending, are being being) conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies Studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) each 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 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 ProspectusSEC Reports; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the SEC Reports; (iv) neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any of the Regulatory Agency Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusSEC Reports; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, if any, and other studies used to support regulatory approval (collectively, “studies”) conducted by or on behalf of or sponsored 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical 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 or the Prospectus 2024 SEC Reports were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 of Sale Prospectuses or the Prospectus2024 SEC Reports; (iii) the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the 2024 SEC Reports; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2024 SEC Reports; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with all applicable study protocols 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 applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals or exemptions as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof Food and Drug Administration of the U.S. Department of Health and Human Services or from any other applicable U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products governmental agency (collectively, the “Regulatory Agencies”), except where the failure to obtain such approval would not reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. (i) The preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) being conducted by the Company or any Subsidiary that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus a 2023 SEC Report were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 of Sale Prospectuses or the Prospectusa 2023 SEC Reports; (iii) the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Boardinstitutional review board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of their respective businesses as described in the 2023 SEC Reports; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2023 SEC Reports; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical 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 or the Prospectus 2024 SEC Reports were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 of Sale Prospectuses or the Prospectus2024 SEC Reports; (iii) the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the 2024 SEC Reports; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2024 SEC Reports; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) conducted by or, to the Company’s knowledge, on behalf of 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies studies, and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, if any, and other studies used to support regulatory approval (collectively, “studies”) conducted by or on behalf of or sponsored by the Company 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 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 FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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 operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) that are described or incorporated by reference in, or the results of which are referred to or incorporated by reference in, the Registration Statement, the Time of Sale Prospectus Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food scientific research procedures, including Good Clinical Practices and Drug Administration (“FDA”)Good Laboratory Practices; 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 described, referred to or incorporated by reference in the Registration Statement, the Time of Sale Prospectuses 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 FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension modification of any ongoing or planned clinical trials that are described or described, 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies used to support regulatory approval (collectively, “studies”) trials 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such clinical trials and studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific research procedures; each description of the results of such clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such clinical trials and studies, and the Company and its subsidiaries have no knowledge of any other clinical trials or 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof U.S. Food and Drug Administration or from any other U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board, each having authority with jurisdiction over biopharmaceutical the types of products being developed by the Company (collectively, the “Regulatory Agencies”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated scientific research procedures; provided, that with respect to any studies being conducted on behalf of or sponsored by the U.S. Food and Drug Administration (“FDA”)Company such representation is to the Company’s knowledge; 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products Board (collectively, the “Regulatory Agencies”)) in connection with the conduct of such studies; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents in all material respects the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise reasonably call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses 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 FDA 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, each having jurisdiction over biopharmaceutical products Board (collectively, the “Regulatory Agencies”)) to conduct its business as currently conducted and as described in the Registration Statement or the Prospectus; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension 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 and regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical 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 or the Prospectus Company Presentation were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 of Sale Prospectuses or the ProspectusCompany Presentation; (iii) the Company and its subsidiaries Subsidiaries have made or will make all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the Company Presentation; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the ProspectusCompany Presentation; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical 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 or the Prospectus 2023 SEC Reports were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 of Sale Prospectuses or the Prospectus2023 SEC Reports; (iii) the Company and its subsidiaries Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the 2023 SEC Reports; (iv) neither the Company nor any of its subsidiaries 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 Registration Statement, the Time of Sale Prospectus or the Prospectus2023 SEC Reports; and (v) the Company and its subsidiaries Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such clinical trials and studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific research procedures; each description of the results of such clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such clinical trials and studies, and the Company and its subsidiaries have no knowledge of any other clinical trials or 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof U.S. Food and Drug Administration or from any other U.S. or foreign government or drug regulatory agency, or health care facility Institutional Review Board, each having authority with jurisdiction over biopharmaceutical the types of products being developed by the Company (collectively, the “Regulatory Agencies”), except where the failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the aggregate, result in a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and any clinical trials, and other studies used to support regulatory approval (collectively, “studies”) conducted by or on behalf of or sponsored 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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies, except for such noncompliance that would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect.

Clinical Data and Regulatory Compliance. The preclinical tests studies and clinical trials, and other studies used to support regulatory approval (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 Information or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific 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 Information or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof Food and Drug Administration of the U.S. Department of Health and Human Services or from any other applicable U.S. or foreign government governmental agency engaged in the regulation of drugs or drug regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products medical devices (including diagnostics) (collectively, the “Regulatory Agencies”), except where the failure to obtain such approval would not reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any Regulatory Agency requiring the termination termination, suspension or suspension modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus Information or the Prospectus, except those which have been removed or are no longer applicable or in effect or are disclosed in the Registration Statement, the Time of Sale Information 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, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and clinical 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 or the Prospectus 2024 SEC Reports were and, if still pending, are being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration scientific research procedures; (“FDA”); ii) 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 Significant 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 Prospectus2024 SEC Reports; (iii) the Company and its subsidiaries Significant Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or any committee thereof or from any other U.S. federal, state or local government or foreign government or drug regulatory agencyDrug Regulatory Agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”)) for the conduct of its business as described in the 2024 SEC Reports; (iv) neither the Company nor any of its subsidiaries Significant Subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus2024 SEC Reports; and (v) the Company and its subsidiaries Significant Subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies used to support regulatory approval (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 being conducted in all material respects in accordance with applicable study protocols the protocols, procedures and controls designed and approved for such studies and with applicable statutes standard medical and regulations promulgated by the U.S. Food and Drug Administration (“FDA”)scientific research procedures, as applicable; each description of the results of such studies is accurate and complete and fairly presents, in all material respects and fairly presents respects, 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; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA 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, each having jurisdiction over biopharmaceutical products Board (collectively, the “Regulatory Agencies”), as applicable, except as could not reasonably 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 termination, suspension or suspension 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, regulations and policies of the Regulatory Agencies.