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Financial Conflict of Interest Policy

1. PURPOSE

This Financial Conflict of Interest Policy (this “Policy”) is put into effect as of July 31, 2022, to protect the integrity and objectivity of the research conducted by Excitant Therapeutics, by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest (“FCOI”). The procedures described in this Policy were designed to comply with the requirements of 42 CFR Part 50 Subpart F federal regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS funding is Sought and Responsible Prospective Contractors, also known as FCOI regulations (the “Regulations”). Excitant Therapeutics shall update this Policy periodically as needed to comply with changes in the Regulations.

2. DEFINITIONS

Financial Conflict of Interest (FCOI): Any significant financial interests that could directly affect the design, conduct or reporting of Research.

Investigator: Project Director (PD), Principal Investigator (PI), and any other person (including subgrantee, subcontractor, and collaborator), regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded Research.

Management: Action taken to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to preserve the integrity and objectivity of Research by ensuring that the design, conduct, and reporting of Research will be free from bias.

PHS Awarding Component: The organizational unit of the U.S. Public Health Service (“PHS”) that funds the research that is subject to 42 CFR Part 50, Subpart F (and 45 CFR Part 94 for contracts).

PHS-funded Research: Research funded under PHS grants, cooperative agreements, or contracts.

Research:  A systemic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). For PHS-Funded Research, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority.

Significant Financial Interest (SFI): A financial interest of the Investigator consisting of one or more of the interests described under section 3.1. of this Policy (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities.

SFI Disclosure: A report that each Investigator shall submit to the Policy Coordinator: (a) at the time of application for Funded Research and prior to the expenditure of any Funding Agency funds therefor; (b) annually thereafter; (b) in the event of certain sponsored travel, as set forth below; and (c) within thirty (30) days of the discovery or acquisition by an Investigator of any SFI.

3. PROCEDURES

3.1 Determination of a Significant Financial Interest (SFI)
 

SFI shall mean a financial interest consisting of one or more of the following interests of the Investigator and his/her immediate family that reasonably appear to be related to the Investigator’s research at Excitant Therapeutics, including:
 

  • With regard to any publicly traded entity, an SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity, subject to the Exemptions defined below, as of the date of disclosure, when aggregated, exceeds $5,000;

  • With regard to any privately held company, a SFI exists if the value of any remuneration received by the Investigator (or the Investigator’s spouse or dependent children) from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest); or

  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or

  • Any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to the Investigator’s research at Excitant Therapeutics, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
     

Exemptions to SFI include:

  • Salaries, royalties, or other remuneration paid by Excitant Therapeutics to the Investigator if the Investigator is currently employed or otherwise appointed by Excitant Therapeutics, including with respect to intellectual property rights assigned to Excitant Therapeutics and agreements to share in royalties related to such rights;

  • Any ownership interest in Excitant Therapeutics held by the Investigator;

  • Income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made by these vehicles;

  • Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local government agency, an institution of higher education as defined at 20 USC 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

  • Income from service on advisory committees or review panels for a federal, state or local government agency, an institution of higher education as defined at 20 USC001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

 

3.2 Responsibilities
 

Investigator is responsible for ensuring that SFI’s of all key personnel are identified and disclosed. Excitant Therapeutics will provide within 5 days a response to a written request for information on any SFI that meets the following conditions:
 

  • The SFI was disclosed and is still held by the PD/PI or any other person identified as senior/ key personnel by Excitant Therapeutics in the award (or subaward) application for PHS funding or listed in a progress report; AND

  • Excitant Therapeutics has determined that the SFI is related to conduct of the research funded.
     

Information made available will include, at a minimum, the following:
 

  • The Investigator’s name;

  • The Investigator’s title and role with respect to the research project;

  • The name of the entity in which the Significant Financial Interest is held;

  • The nature of the Significant Financial Interest; and

  • The approximate dollar value of the Significant Financial Interest in the following ranges: $0-$4,999; $5,000-9,999; $10,000 - $19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000, OR:

  • A statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.


If a significant FCOI is determined, a management plan is defined and implemented to mitigate the FCOI effect on the project.

3.3 Reporting requirements to NIH
 

Routine FCOI Reports are submitted to NIH:
 

  • Prior to expenditure of funds on an approved project (this may be done as a Just In Time (JIT) submission for project approval)

  • Within 60 days of FCOI identification for a new participant or change in FCOI situation for existing investigators

  • Annually, with the required annual progress report.

  • As needed for changes in previous reports for finding of:

    • Bias in conduct or reporting of funded research

    • Failure of an investigator to comply with this company procedure

    • Failure to comply with a FCOI management plan are to be reported promptly with a mitigation report detailing actions taken

Reports are submitted via the eRA Commons FCOI Module. Demonstration and Instructions are provided at: http://grants.nih.gov/grants/policy/coi/fcoi_webinar_2012/FCOI%208-14-2012_WEBINAR.pptx and further information at http://grants.nih.gov/grants/policy/coi/index.htm

3.4 Records

Excitant Therapeutics will maintain records of all SFI disclosures, and records of resulting company management or other action with respect to the respective FCOI, for at least three years from the date of submission of the final expenditures report for the applicable PHS-funded Research.

 

3.5 Compliance

 

Within 120 days of any determination by Excitant Therapeutics that an Investigator has failed to comply with this Policy, Excitant Therapeutics shall complete a retrospective review of such Investigator’s activities to determine the possibility of any bias in such Investigator’s research activities. If Excitant Therapeutics determines that there has been any such bias, Excitant Therapeutics shall submit a mitigation report to the applicable Funding Agency, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the PHS-funded research and the actions Excitant Therapeutics has taken to mitigate the bias and manage the FCOI.  Excitant Therapeutics will work with the Investigator to establish an FCOI management plan, and the Investigator shall disclose the FCOI in each public presentation related to the results of the applicable PHS-funded Research if not previously disclosed. In certain instances, the Investigator may be prohibited from continuing to work on the project or receiving any NIH funding in the future.

3.6 Training

 

3.6.1. All Investigators are required to complete NIH Office of Extramural Research FCOI online tutorial (https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html) prior to engaging in PHS-funded research, and provide the Company with proof of completion.

3.6.2. Investigators are required to complete training at least every four years and must immediately complete training when:

  • Excitant revises this Policy that affects requirements of Investigators;

  • An Investigator is new to Excitant; or

  • Excitant determines that an Investigator is not in compliance with this Policy.

3.7 Public Access

 

This policy will be publicly available on the Company’s website at www.excithera.com, and certain information regarding FCOIs will be available within five days of a qualified written request therefor.