Common use of Clinical Data and Regulatory Compliance Clause in Contracts

Clinical Data and Regulatory Compliance. 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 SEC Reports 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 with standard medical and scientific research procedures; (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 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 SEC 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC 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. 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 or on behalf of, or sponsored by, the Company or its subsidiaries that are described in, or the results of which are referred to in, the SEC Reports were (and, if still pending, are being) conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies is 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 SEC 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and clinical trials trials, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 materially inconsistent with, or otherwise call into question, the results described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and applicable study protocols approved for such Studies studies and with standard medical applicable statutes and scientific research proceduresregulations promulgated by the U.S. Food and Drug Administration (“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 SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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 Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. 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 2024 SEC Reports were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 2024 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2024 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and clinical trials trials, if any, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension material modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

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

Clinical Data and Regulatory Compliance. 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 2024 SEC Reports were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 2024 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2024 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the 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 SEC Reports Registration Statement or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with all applicable laws and regulations, including, without limitation, the Federal Food, Drug and Cosmetic Act and its implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312, with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 SEC ReportsRegistration Statement or the Prospectus; (iii) 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and clinical trials trials, if any, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being 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 SEC Reports Registration Statement, the Pricing Disclosure Package or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 SEC ReportsRegistration Statement, the Pricing Disclosure Package or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension material modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Pricing Disclosure Package or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. 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 or on behalf of, or sponsored by, the Company or its Subsidiaries that are described in, or the results of which are referred to in, the SEC Reports were (and, if still pending, are being) conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies is 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 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 Subsidiaries has received any notice of, or correspondence from, any of the Regulatory Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 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. 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 2023 SEC Reports were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2023 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests studies 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies clinical trials and studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such Studiesclinical 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 SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA U.S. Food and Drug Administration or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Board, each having regulatory authority with jurisdiction over biopharmaceutical the types of products being developed by the Company (collectively, the “Regulatory Agencies”) for ), except where the conduct of its business as described failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the SEC Reportsaggregate, result in a Material Adverse Effect; (iv) neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any of the Regulatory Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the 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 SEC Reports Registration Statement or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (ii) provided, that with respect to any studies being conducted on behalf of or sponsored by the Company such representation is to the Company’s knowledge; 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 SEC ReportsRegistration Statement or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (collectively, the “Regulatory Agencies”) for in connection with the conduct of its business as described in the SEC Reportssuch studies; (iv) neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any of the Regulatory Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. 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 2024 SEC Reports were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 2024 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2024 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and any clinical trials trials, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 materially inconsistent with, or otherwise call into question, the results described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests studies and clinical trials trials, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being conducted by or, to the Company knowledge of the Company, for the Company, or that are described in, or the results of which are referred to in, the SEC Reports Registration Statement, the Time of Sale Information or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 SEC ReportsRegistration Statement, the Time of Sale Information or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA Food and Drug Administration of the U.S. Department of Health and Human Services or from any other applicable U.S. federal, state or local government or foreign government governmental agency engaged in the regulation of drugs or Drug Regulatory Agency, or Institutional Review Board, each having jurisdiction over biopharmaceutical products medical devices (including diagnostics) (collectively, the “Regulatory Agencies”) for ), except where the conduct of its business as described in the SEC Reportsfailure to obtain such approval would not reasonably be expected to have a Material Adverse Effect; (iv) neither the Company nor any of its subsidiaries has received any written notice of, or other correspondence from, any of the Regulatory Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale 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 (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. 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 SEC Reports Company Presentation were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 SEC ReportsCompany 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the conduct of its business as described in the SEC ReportsCompany Presentation; (iv) neither the Company nor any of its subsidiaries Subsidiaries has received any notice of, or correspondence from, any of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsCompany 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and clinical trials trials, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being conducted by the Company or any Subsidiary that are described in, or the results of which are referred to in, the a 2023 SEC Reports Report were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 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 a 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Boardinstitutional review board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the conduct of its business 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2023 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the 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 or incorporated by reference in, or the results of which are referred to or incorporated by reference in, the SEC Reports Registration Statement or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures, including Good Clinical Practices and Good Laboratory Practices; (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 described, referred to or incorporated by reference in the SEC ReportsRegistration Statement or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension modification of any ongoing or imposing any clinical hold on any planned clinical trials that are described or described, referred to or incorporated by reference in the SEC ReportsRegistration Statement or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests studies and clinical trials and other studies used to support regulatory approval (collectivelytrials, “Studies”) being conducted by the Company that are described in, or the results of which are referred to in, the SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies clinical trials and studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies clinical trials and studies is accurate and complete in all material respects and fairly presents the data derived from such Studiesclinical 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 SEC ReportsRegistration Statement, the Time of Sale Prospectuses or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA U.S. Food and Drug Administration or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Board, each having regulatory authority with jurisdiction over biopharmaceutical the types of products being developed by the Company (collectively, the “Regulatory Agencies”) for ), except where the conduct of its business as described failure to make such filing or obtain such approval would not reasonably be expected to, individually or in the SEC Reportsaggregate, result in a Material Adverse Effect; (iv) neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any of the Regulatory Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the preclinical tests and The 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 SEC Reports Registration Statement or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies studies is accurate and complete in all material respects and fairly presents in all material respects the data derived from such Studiesstudies, 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 SEC ReportsRegistration Statement or the Prospectus when viewed in the context in which such results are described and the clinical state of development; (iii) 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (collectively, the “Regulatory Agencies”) for the to conduct of its business as currently conducted and as described in the SEC ReportsRegistration Statement or the Prospectus; (iv) neither the Company nor any of its subsidiaries has received any written notice of, or correspondence from, any of the Regulatory Agencies Agency requiring the termination termination, suspension or suspension material modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, rules and regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. 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 2024 SEC Reports were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies and with standard medical and scientific research procedures; (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 Subsidiaries have no knowledge of any other studies the results of which are required to be disclosed in accordance with the Exchange Act and are inconsistent with, or otherwise call into question, the results described or referred to in the 2024 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 of the Regulatory Agencies Agency requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the 2024 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. 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 SEC Reports 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 with standard medical and scientific research procedures; (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 subsidiary have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Reports; (iii) the Company and its subsidiaries subsidiary have made all such filings and obtained all such approvals as may be required by the FDA or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 subsidiary has received any notice of, or correspondence from, any of the Regulatory Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC Reports; and (v) the Company and its subsidiaries subsidiary 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. Except as would not reasonably be expected to result in a Material Adverse Effect: (i) the The preclinical tests and clinical trials trials, and other studies used to support regulatory approval (collectively, “Studiesstudies”) being 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 SEC Reports Registration Statement, the Time of Sale Prospectus or the Prospectus were (and, if still pending, are being) being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies studies, and with standard medical and scientific research procedures; (ii) each description of the results of such Studies studies is accurate and complete in all material respects and presents fairly presents the data derived from such Studiesstudies, 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 SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; (iii) the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the 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. federal, state or local government or foreign government or Drug Regulatory Agencydrug or medical device regulatory agency, or health care facility Institutional Review Board, each having jurisdiction over biopharmaceutical products Board (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 Agencies Agency requiring the termination termination, suspension or suspension modification of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC ReportsRegistration Statement, the Time of Sale Prospectus or the Prospectus; and (v) the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

Clinical Data and Regulatory Compliance. 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 SEC Reports 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 with standard medical and scientific research procedures; (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 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 SEC 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 from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or Institutional Review Board, each having jurisdiction over biopharmaceutical products (collectively, the “Regulatory Agencies”) for the conduct of its current 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 Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC 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. 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 SEC Reports 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 with standard medical and scientific research procedures; (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 the 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 SEC Reports; (iii) the Company and its subsidiaries the Subsidiaries have made all such filings and obtained all such approvals as may be required by the FDA or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 Subsidiary has received any notice of, or correspondence from, any of the Regulatory Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC Reports; and (v) the Company and its subsidiaries the 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. 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 or on behalf of, or sponsored by, the Company or its subsidiary that are described in, or the results of which are referred to in, the SEC Reports were (and, if still pending, are being) conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such Studies and with standard medical and scientific research procedures; (ii) each description of the results of such Studies is accurate and complete in all material respects and fairly presents the data derived from such Studies, and the Company and its subsidiaries subsidiary have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Reports; (iii) the Company and its subsidiaries subsidiary have made all such filings and obtained all such approvals as may be required by the FDA or from any other U.S. federal, state or local government or foreign government or Drug Regulatory Agency, or 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 subsidiary has received any notice of, or correspondence from, any of the Regulatory Agencies requiring the termination or suspension of or imposing any clinical hold on any clinical trials that are described or referred to in the SEC Reports; and (v) the Company and its subsidiaries subsidiary have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.