Financial Conflict of Interest (FCOI) Policy

Purpose

The purpose of this policy is to establish Protego Biopharma, Inc. (the Company) requirements for identifying, disclosing, reviewing, reporting, and managing financial conflicts of interest in research in order to safeguard research integrity and comply with applicable federal requirements.

This policy is intended to comply with the 2011 revised Public Health Service financial conflict of interest regulations, Promoting Objectivity in Research (42 CFR Part 50, Subpart F), and related NIH requirements applicable to research funded under NIH grants or cooperative agreements.

Summary of Process

Each Investigator must disclose any Significant Financial Interest (SFI), as defined in this policy, on the Company’s Significant Financial Interest Disclosure Form (Exhibit 1) before submission of a proposal for government-sponsored or Company-sponsored research, before engaging in funded research, and within 30 days of discovering or acquiring a new SFI during the course of research.

Regardless of whether an SFI exists, all Investigators and key personnel must submit an SFI Disclosure Form at least annually.

The Principal Investigator is responsible for identifying all Investigators on a project who are required to disclose under this policy and for ensuring required disclosures are submitted in connection with proposal submission, award set-up, and any human subjects or other compliance review, as applicable.

The Chief Executive Officer (CEO), with support from designated finance, legal, and other advisors as appropriate, is responsible for reviewing disclosures, determining whether an SFI is related to research and whether it constitutes a financial conflict of interest (FCOI), implementing and monitoring management plans when required, and ensuring required sponsor and governmental reporting.

No expenditure of funds under an NIH-funded award may occur until all required disclosures have been reviewed and any identified FCOI has been managed and reported as required.

All Investigators and key personnel participating in research must provide annual updates and must promptly report newly acquired or increased financial interests using the SFI Disclosure Form.

Training

FCOI training is required for each Investigator, consultant, and employee who is responsible for the design, conduct, or reporting of NIH-funded research, or who administers or supports compliance with this policy for NIH-funded research.

Training must be completed prior to engaging in NIH-funded research and at least once every four (4) years thereafter, and immediately when any of the following occurs:

• The Company revises this policy or its procedures in a manner that affects Investigator requirements.
• An Investigator is new to the Company.
• The Company finds that an Investigator is not in compliance with this policy or an applicable management plan.

The NIH FCOI training resources may be accessed through NIH training materials made available by the agency. Evidence of completion must be provided to the CEO or the CEO’s designee, and each individual should retain a copy for their records.

Key Definitions

Institution – Any domestic or foreign, public or private, entity or organization (excluding a federal agency) applying for, or receiving, NIH research funding.

Investigator – The project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, including, for example, collaborators or consultants.

Institutional responsibilities – An Investigator’s professional responsibilities on behalf of the Institution, as defined by the Institution, including research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Financial interest – Anything of monetary value, whether or not the value is readily ascertainable.

Financial conflict of interest (FCOI) – A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.

Manage – Taking action to address an FCOI, which can include reducing or eliminating the conflict, to ensure to the extent possible that the design, conduct, and reporting of research will be free from bias.

Senior/Key Personnel – The PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH under the regulation.

Significant Financial Interest (SFI)

For purposes of this policy, a Significant Financial Interest means one or more of the following interests of the Investigator, and those of the Investigator’s spouse and dependent children, if the interest reasonably appears to be related to the Investigator’s institutional responsibilities:

1. With regard to a publicly traded entity, remuneration received from the entity in the 12 months preceding the disclosure, when aggregated with the value of any equity interest in the entity as of the date of disclosure, exceeds $5,000.
2. With regard to a non-publicly traded entity, remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or the Investigator or the Investigator’s spouse or dependent children hold any equity interest in the entity, such as stock, stock options, or another ownership interest.
3. Income related to intellectual property rights and interests, such as patents and copyrights, upon receipt of that income.
4. Any reimbursed or sponsored travel related to the Investigator’s institutional responsibilities, except travel that is reimbursed or sponsored by excluded sources under applicable regulations. At a minimum, the disclosure must include the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration. The Company may request additional details, including monetary value, as needed to determine whether the travel constitutes an FCOI.

The term Significant Financial Interest does not include:

• Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution.
• Intellectual property rights assigned to the Institution and agreements to share in royalties related to those rights.
• Any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization, to the extent excluded by applicable regulation.
• Income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in those vehicles.
• Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
• Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

Procedures

A. Identification of Persons Required to Disclose an SFI

The Principal Investigator is responsible for identifying all Investigators on a research project who are subject to this policy and for ensuring that each such individual submits an SFI Disclosure Form before proposal submission, before expenditure of funds when required, annually thereafter, and within 30 days of discovering or acquiring a new or increased SFI.

B. Submission and Review of SFI Disclosure Form

Each individual with an SFI requiring disclosure under this policy must submit a complete SFI Disclosure Form to the CEO or the CEO’s designee. The Company will review each disclosure to determine whether an SFI exists, whether the SFI is related to the research, and whether the SFI constitutes an FCOI. When needed, the Company will implement a written management plan that specifies the actions required to manage, reduce, or eliminate the conflict and to ensure compliance with this policy.

Management actions may include, as appropriate:

• Public disclosure of significant financial interests;
• Review of research protocols by independent reviewers;
• Monitoring of research by independent reviewers;
• Modification of the research plan;
• Disqualification from participation in all or a portion of the funded research;
• Divestiture of significant financial interests; and
• Severance of relationships that create actual or potential conflicts.

All management plans must be acknowledged by the Investigator and approved by the CEO or the CEO’s designee. Compliance with each management plan must be monitored by the Company.

C. Annual Reporting and After-Acquired SFI

All Investigators must submit annual SFI Disclosure Forms and any additional updates required under an applicable management plan. Any Investigator who acquires or discovers a new or increased SFI must submit an updated disclosure within 30 days. The Principal Investigator is responsible for ensuring that any newly added Investigator on a project submits the required disclosure promptly.

D. Violations of This Policy

Investigators are expected to comply fully and promptly with this policy. If an individual fails to make a required disclosure, fails to comply with a management plan, or otherwise violates this policy, the CEO will evaluate the matter and may recommend corrective actions, sanctions, or disciplinary measures as appropriate. The Company will also comply with applicable federal requirements for retrospective review, mitigation, and sponsor notification when noncompliance is identified.

E. Record Retention

Records relating to Investigator disclosures and to the Company’s review and management of actual or potential conflicts of interest must be retained for at least three (3) years from the date of submission of the final expenditures report to the NIH, or for any longer period required under applicable law, regulation, award terms, or record-retention requirements.

F. Subrecipient Requirements

Any subrecipient under an NIH-funded project must either comply with this policy or certify that it maintains a compliant financial conflict of interest policy consistent with applicable federal requirements. The written agreement with the subrecipient must specify whether this policy or the subrecipient’s policy applies, the time frame for disclosure reporting, and the information needed by the Company to satisfy its reporting obligations to the NIH. If a subrecipient identifies an FCOI related to work under the subaward, it must provide the required information to the Company in sufficient time for the Company to meet its reporting obligations.

G. Federal Reporting

The Company is responsible for submitting all required FCOI reports to the NIH or other applicable sponsor, including initial, updated, annual, and retrospective reports, within the time frames required by applicable regulations and award terms. No NIH funds may be expended until any required initial FCOI report has been submitted. If a new FCOI is identified during an ongoing project, the Company will report it within 60 days, and when required by regulation, will conduct and document a retrospective review and implement mitigation measures.

H. Public Accessibility

For NIH-funded research, the Company will make information concerning identified FCOIs held by senior/key personnel publicly accessible as required by applicable law and regulation.

Responsible Office

The CEO, or a designated Company official acting on the CEO’s behalf, is responsible for administration of this policy, including review of disclosures, determinations, management plans, training oversight, record retention coordination, and required sponsor reporting.

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Exhibit I – Significant Financial Interest Disclosure Form (PDF)