Financial Conflict of Interest (FCOI) Policy

Effective Date: July 21, 2025

1. Scope and Purpose

This Financial Conflict of Interest (FCOI) Policy applies to all research funded by the U.S. Public Health Service (PHS), including the National Institutes of Health (NIH), conducted at or on behalf of Vivid Bioinnovations, PBC (the “Company”). It is applicable to all employees, subrecipients, consultants, and any other persons defined as “Investigators” who are involved in the design, conduct, or reporting of PHS-funded research.

The purpose of this Policy is to ensure the objectivity and integrity of PHS-funded research by establishing standards and procedures to identify, manage, and report financial conflicts of interest in accordance with federal regulations, specifically 42 C.F.R. Part 50, Subpart F (“Promoting Objectivity in Research”).

2. Key Definitions

  • Investigator: Any person, regardless of title or position, who is responsible for the design, conduct, or reporting of PHS-funded research. This includes the Principal Investigator, co-investigators, and any other key personnel identified as such in a grant application, progress report, or other submission to the PHS.
  • Significant Financial Interest (SFI): A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities on behalf of the Company:
    • Publicly Traded Entity: If the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship). Equity interest includes any stock, stock option, or other ownership interest.
    • Non-Publicly Traded Entity: If the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
    • Intellectual Property Rights: Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
    • Sponsored Travel: Investigators must also disclose the occurrence of any reimbursed or sponsored travel related to their institutional responsibilities. This does not apply to travel sponsored or reimbursed by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, or a medical center.
  • SFI Exclusions: The term Significant Financial Interest does not include:
    • Salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company.
    • Intellectual property rights assigned to the Company and agreements to share in royalties related to such rights.
    • Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.
    • Income from seminars, lectures, or teaching engagements sponsored by a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, or a medical center.
    • Income from service on advisory committees or review panels for a U.S. federal, state, or local government agency, a U.S. institution of higher education, an academic teaching hospital, or a medical center.
  • Financial Conflict of Interest (FCOI): A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

3. Policy Administration

  • FCOI Officer: The Company shall designate an FCOI Officer (who may be the Chief Executive Officer or another designated official) who is responsible for the administration of this Policy, including the solicitation and review of SFI disclosures.
  • Training: Each Investigator must complete FCOI training prior to engaging in PHS-funded research, at least every four years, and immediately if the Company revises this Policy, an Investigator is new to the Company, or an Investigator is found to be non-compliant with this Policy or a management plan.
  • Public Accessibility: This Policy shall be made publicly accessible on the Company’s website.

4. Disclosure, Review, and Reporting

  • Disclosure: Each Investigator is required to disclose all of their SFIs (and those of their spouse and dependent children) to the FCOI Officer:
    • At the time of applying for PHS funding;
    • At least annually during the period of any award; and
    • Within 30 days of discovering or acquiring a new SFI.
  • Review: The FCOI Officer will review each disclosure to determine if an SFI relates to PHS-funded research and, if so, whether it constitutes an FCOI. An FCOI exists when the FCOI Officer determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
  • Management: If an FCOI is identified, the FCOI Officer will develop and implement a written management plan to manage, reduce, or eliminate the conflict. Examples of conditions that might be imposed include:
    • Public disclosure of the FCOI (e.g., when presenting or publishing the research);
    • Monitoring of research by independent reviewers;
    • Modification of the research plan;
    • Disqualification from participation in all or a portion of the research;
    • Divestiture of the SFI; or
    • Severance of the relationship that creates the financial conflict.
  • Reporting: The Company, through its FCOI Officer, will report all identified FCOIs to the relevant PHS awarding component:
    • Prior to the expenditure of any funds under a PHS-funded award;
    • Within 60 days of identifying a new FCOI for an existing Investigator;
    • Within 60 days of identifying an FCOI for a new Investigator; and
    • Annually for the duration of the award. Information concerning FCOIs held by senior/key personnel will be made publicly available by written response within five business days of a request.

5. Subrecipients

The Company will enter into a written agreement with any subrecipient to ensure that the subrecipient is compliant with all applicable PHS FCOI regulations. The agreement will specify whether the subrecipient will follow this Policy or its own compliant FCOI policy and will establish timeframes for the subrecipient to report any identified FCOIs to the Company to ensure timely reporting to the PHS.

6. Non-Compliance

Failure to comply with this Policy may result in disciplinary action. If an FCOI is not timely identified or managed, or if an Investigator fails to comply with a management plan, the FCOI Officer will, within 120 days of determining non-compliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any research conducted during the period of non-compliance was biased in the design, conduct, or reporting of such research.

If bias is found, the Company will promptly notify the PHS awarding component and submit a mitigation report. The Company will work with the Investigator to implement any necessary corrective actions.

7. Records Management

The Company will maintain all records relating to FCOI disclosures, reviews, and management plans for at least three (3) years from the date the final expenditures report is submitted to the PHS for the relevant grant.