Financial Conflict of Interest (FCOI) Policy

Purpose

This document establishes policies regarding financial conflicts of interest (FCOI) at Everglades Biopharma, LLC, (the "Company"). The aim is to ensure that employees and other personnel avoid situations where personal interests affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research. This policy provides guidance to help personnel manage potential conflicts arising from personal affairs, external employment, and financial activities, ensuring compliance with relevant federal laws when engaged in government-funded research. Personnel are required to promptly disclose any circumstances that may fall under the purview of this policy.

This policy applies to Company members serving as investigators, collaborators, consultants, and subawardees/subrecipients on government-funded research projects. For subawardees/subrecipients engaged in Company’s research projects, compliance with either the Company’s FCOI policy or that of their institution of employment, will be established through research agreements, ensuring compliance with federal regulations.

Implementation of Policy

This policy is designed to comply with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements, and 45 CFR Part 94 for contracts. These standards and procedures aim to guarantee the impartiality of the design, conduct, or reporting of research funded under PHS grants, cooperative agreements, or contracts. The Company’s Conflict of Interest Policy implements the requirements of these federal regulations.

Disclosure Requirements 

PHS-funded investigators must submit a Financial Interest Disclosure Form to the Company Official before submission of a proposal to PHS. Upon completion, the disclosure indicates that the investigators either have no significant financial interests (SFIs) or a listing of known SFIs (and those of the spouse and dependent children). Financial disclosures must be updated annually by all investigators during the award period. After the initial report, any newly identified SFIs must be promptly disclosed to the Company within 30 days of discovering or acquiring a new SFI. If any SFIs constitute a FCOI, the Company will then report it to the PHS Awarding Agency that issued the award within 60 days. Sub-recipients working on PHS-funded projects must complete and submit a sub-recipient FCOI disclosure form to the Company Official within 30 days.

Management of a FCOI

Once SFIs are disclosed, the Company’s designated official(s) will reasonably determine whether any SFIs constitute FCOI that could directly and significantly affect the design, conduct or reporting of the PHS-funded research. If yes, an FCOI management plan must be developed. This plan should encompass details such as the Investigator's role and principal duties related to the FCOI, the strategy employed to uphold objectivity in the PHS research project, confirmation of the Investigator's agreement with the FCOI Management Plan, and the monitoring mechanisms. Components of the management plan may include public disclosure, independent review, adjustments to the Research plan or other measures as determined by the Company and its Policy Coordinator. For instance, if Investigators have ownership interests in external entities that constitute a FCOI, the disclosure of their SFIs is required in publications and presentations.

Training

All investigators and employees of everglades Biopharma are required to complete FCOI training before participating in research related to any PHS-funded grant, or as deemed necessary by the Company due to changes in the FCOI policy, non-compliance by any investigator, or upon joining the Company. At a minimum, the FCOI training shall be taken every three (3) years. Sub-recipient organizations must certify that their investigators have completed the required training.

The NIH Financial Conflict of Interest tutorial is accessible at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. Upon completion of the training, a certificate of completion must be submitted to a Company Official.

Reporting

If an FCOI is identified, it will be documented in the FCOI report through the eRA Commons FCOI module.

FCOI Criteria and Definitions

Financial conflict of interest (FCOI) – A financial conflict of interest exists when the institution's designated official(s) reasonably determines that an investigator’s SFI could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The institution is required to review each Investigator SFI disclosure to determine if a SFI:

1. is related to the NIH-supported research (i.e., could the SFI be affected by the research or is the SFI in an entity whose financial interest could be affected by the research) and

2. could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. For instance, this may include (a) the Investigator (or their spouse/child/dependent) holds a SFI in an entity sponsoring their research project; (b) the Investigator (or their spouse/child/dependent) possesses a SFI in an entity manufacturing products (such as equipment, software, compounds, drugs, devices, etc.) or services utilized in their research project; (c) the Investigator (or their spouse/child/dependent) maintains a SFI in an entity developing products or services that their research project aims to evaluate or advance; or (d) the Investigator (or their spouse/child/dependent) holds a SFI in an entity for which they provide consulting services in an area overlapping with or constituting the primary subject of their research.

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:

a. With regard to any publicly traded entity, a significant financial interest exists 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;

b. With regard to any non-publicly traded entity, a significant financial interest exists 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 the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);

c. Upon receipt of income related to intellectual property rights and interests (e.g., patents, copyrights) that exceeds $5000; or

d. Any reimbursed or sponsored travel related to Investigators' institutional responsibilities, in the twelve months preceding the disclosure, when aggregated, exceeds $5,000. The Institution will require the Investigator to disclose the details of travel disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

e. The above-described interests apply to both domestic and foreign income sources. Investigators are required to disclose all financial interests from foreign sources, including foreign institution of higher education or the government of another country if such income meets the threshold for disclosure (e.g., $5,000).

The term Significant Financial Interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Company to the Investigator if the Investigator is currently employed or otherwise appointed by the Company, including intellectual property rights assigned to the Company and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Company is a commercial or for-profit organization; 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 Federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a Untied States Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States, a United States 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 a United States Institution of higher education. 

Financial Interest – Anything of monetary value, regardless of whether its value is readily ascertainable.

Investigator – The project director (PD) or principal investigator (PI) and any other personnel, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the PHS, which may include, for example, collaborators or consultants.

Violations of Conflict of Interest Policy 

Non-compliance with the Company’s FCOI policy, which includes the failure to disclose financial interests or adhere to the requirements of the management plan, may result in sanctions or disciplinary proceedings imposed by the Company Official against the individual in violation. Non-compliance of the FCOI policy incudes: i) failure by the Investigator to disclose a SFI that is determined by the Institution to constitute a FCOI; ii) failure by the Institution to review or manage such a FCOI; or iii) failure by the Investigator to comply with a FCOI management plan. Retrospective reviews, completed and documented by the Company Official within 120 days of the Institution determining noncompliance, are mandated for SFIs not disclosed in a timely manner or previously reviewed or whenever an FCOI is not identified or managed promptly. The Company Official must document these reviews consistently with the Regulations.

In situations where the Department of Health and Human Services determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with an FCOI that was not compliantly managed or reported, the Investigator involved will be required to: (a) disclose the FCOI in each public presentation of the results of the research, and (b) to request an addendum to previously published presentations.

If bias is found, the Company will notify and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review (discussed above) and a description of the impact of the bias on the research project and the Company’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).

The Institution will document the retrospective review which must include at least the following key elements: 

A. Project number;

B. Project title;

C. PD/PI or contact PD/PI if a multiple PD/PI model is used;

D. Name of the Investigator with the FCOI;

E. Name of the entity with which the Investigator has a financial conflict of interest;

F. Reason(s) for the retrospective review;

G. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);

H. Findings of the review; and

I. Conclusions of the review.

Prompt notification to NIH and corrective action for noncompliance with the Company policy or the management plan, such as the potential removal of the Investigator and/or the Institution from further participation in COMPANY research activities, and other disciplinary actions, up to and including termination, shall be undertaken by the Company Official.

Records Management 

The records of all financial disclosures and all actions taken to manage actual or potential conflicts of interest, shall be maintained by Company Official for three (3) years from the date the final expenditure report is submitted to the NIH, or as required by 45 CFR. 75.361 under specific circumstances.

Subrecipient Requirements

All subrecipients receiving funds under the Company’s PHS-funded research are required to adhere to an FCOI policy that aligns with federal FCOI regulations. Regarding these subrecipients, subcontractors, and collaborators, the Company is mandated to ensure that these entities enter into a written agreement specifying the Investigator will follow the FCOI policy (either that of the awardee Institution or the subrecipient). The agreement must also include requirements for reporting identified FCOIs within a timeframe enabling the Company to report them to NIH as stipulate by the Regulations. Alternatively, the Company may solicit and review subrecipient Investigator disclosures to facilitate the identification, management, and reporting of FCOIs in line with NIH requirements.

If an SFI is identified by the subaward recipient, they are obligated to notify the Company Official of the conflicting interest's existence within 45 days of identification. Additionally, the subaward recipient must certify and assure that any reported conflicting interest has been managed, reduced, or eliminated in accordance with the Regulations.

The Company will promptly report to the PHS funding agency any identified FCOI reported by subrecipients, subcontractors, or collaborators in accordance with federal FCOI regulations. This reporting should occur before the expenditure of funds and within 60 days of any subsequently identified FCOI.

Public Accessibility 

The Company will ensure public access to this policy on the publicly accessible webpage at www.evergladesbiopharma.com. Updated versions of this policy will be promptly posted upon implementation. In response to any requestor, the Company commits to providing a written response within five business days of a request for information pertaining to any SFI disclosed to the Company, meeting the following three criteria: (a) The SFI was disclosed and is still held by the senior/key personnel; (b) The Company determines that the SFI is related to the PHS-funded research; and (c) The Company determines that the SFI is a FCOI. The information will include the minimum elements as provided in the regulation and will remain available for three years from the date of the most recent update.