Financial Conflict of Interest Policy

Effective Date: January 1, 2026

1. Purpose

Armor Medical, Inc. ("Armor Medical" or "the Company") is committed to ensuring that the design, conduct, and reporting of its research are objective and free from bias resulting from investigator financial conflicts of interest.

This policy establishes Armor Medical's requirements for identifying, disclosing, reviewing, managing, and reporting investigator financial conflicts of interest in research. It implements the requirements of the U.S. Public Health Service (PHS) regulation, Promoting Objectivity in Research (42 CFR Part 50, Subpart F), which applies to research funded by PHS agencies, including the National Institutes of Health (NIH). As a matter of Company policy, these requirements also apply to other sponsored research unless the applicable sponsor's terms specify different conflict of interest requirements.

2. Scope

This policy applies to all Investigators participating in research conducted by or on behalf of Armor Medical. “Investigator” means the project director or principal investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research — including employees, officers, consultants, contractors, interns, and collaborators. It also applies to subrecipients as described in Section 10.

The provisions of this policy apply to all PHS-funded research subject to 42 CFR Part 50, Subpart F. As a matter of Company policy, these requirements also apply to other sponsored research unless the applicable sponsor's terms specify different conflict of interest requirements.

3. Definitions

Significant Financial Interest (SFI). A financial interest of the Investigator (including those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities, consisting of one or more of the following:

Remuneration from a publicly traded entity in the 12 months preceding disclosure, plus the value of any equity in that entity, that in aggregate exceeds $5,000;
Remuneration from a non-publicly traded entity in the 12 months preceding disclosure that exceeds $5,000, or any equity interest in a non-publicly traded entity (e.g., stock, stock options, or other ownership interest, regardless of value);
Intellectual property rights and interests (e.g., patents, copyrights) and royalties from such rights, upon receipt of income related to those rights exceeding $5,000;
Reimbursed or sponsored travel related to institutional responsibilities (disclosure of purpose, sponsor, destination, and duration; excludes travel sponsored by federal, state, or local government agencies, U.S. institutions of higher education, academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education).

SFI does not include: salary or other remuneration paid by Armor Medical to the Investigator; income from investment vehicles (mutual funds, retirement accounts) where the Investigator does not directly control investment decisions; income from seminars, lectures, teaching, or service on advisory or review panels sponsored by government agencies, institutions of higher education, academic teaching hospitals, medical centers, or affiliated research institutes.

Financial Conflict of Interest (FCOI). An SFI that the Designated Official determines could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Designated Official (DO). The Company official responsible for overseeing Armor Medical's Financial Conflict of Interest (FCOI) program. The DO is responsible for reviewing Significant Financial Interest (SFI) disclosures, determining whether disclosed SFIs are related to Company-sponsored research and constitute FCOIs, approving and overseeing management plans, ensuring compliance with applicable regulations, and submitting required FCOI reports to sponsors. The Chief Executive Officer serves as the Designated Official unless another qualified individual is designated by the Company. If the DO has a disclosed SFI under review or is otherwise conflicted with respect to a particular disclosure, the review will be conducted by an alternate non-conflicted Company officer or an independent external reviewer, and that substitution will be documented.

Institutional Responsibilities. An Investigator’s professional responsibilities on behalf of Armor Medical, including research, product development, consultation, and service activities.

4. Company Responsibilities

Under 42 CFR Part 50, Subpart F, Armor Medical must, and hereby commits to:

Maintain this written, enforced FCOI policy and make it publicly accessible via the Company website (Section 11);
Inform each Investigator of this policy, the Investigator’s disclosure responsibilities, and the applicable federal regulations;
Require and track completion of FCOI training as described in Section 5;
Solicit and review SFI disclosures, determine whether any SFI constitutes an FCOI, and implement management plans where required;
Provide initial and annual FCOI reports to NIH through the eRA Commons FCOI Module (or to other sponsors as their terms require) prior to the expenditure of funds and as required throughout the period of award;
Maintain enforcement mechanisms and employee sanctions to ensure Investigator compliance (Section 13);
Upon request, make information promptly available to the sponsoring agency relating to any Investigator disclosure and the Company’s review of and response to it, whether or not the disclosure resulted in a determination of FCOI;
Complete retrospective reviews and, where bias is found, mitigation reports (Section 12); and
Maintain records as described in Section 14.

5. FCOI Training

Each Investigator must complete FCOI training before engaging in research funded by PHS/NIH, and at least every four years thereafter. Training must be repeated immediately if: (a) this policy is revised in a way that materially affects Investigator requirements; (b) an Investigator is new to the Company; or (c) the Company finds an Investigator noncompliant with this policy or a management plan.

Approved training: NIH Financial Conflict of Interest Tutorial or another Company-approved equivalent.
Upon completion, the Investigator must save the completion certificate as a PDF and submit the completion certificate to the Company-designated compliance administrator.
The Designated Official (or delegate) maintains records of Investigator training completion and renewal dates.

6. Disclosure of Significant Financial Interests

Each Investigator must disclose SFIs — including those of a spouse and dependent children — that reasonably appear related to the Investigator’s institutional responsibilities, using Company-designated disclosure forms. Disclosures are required:

Initially: no later than the time of application for PHS/NIH funding, and before beginning work on an awarded project;
Annually: at least once every 12 months during the period of award, updating any previously disclosed SFI and adding any information not previously disclosed;
Within 30 days: of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance).

7. Review of Disclosures and FCOI Determination

The Designated Official reviews each disclosure within 30 days of receipt and applies the following two-step analysis, documenting the basis for each determination:

Relatedness: Is the SFI related to PHS-funded research — i.e., could the SFI be affected by the research, or is it in an entity whose financial interest could be affected by the research? The DO may involve the Investigator in this determination.
Conflict: If related, could the SFI directly and significantly affect the design, conduct, or reporting of the research? If yes, the SFI is an FCOI and a management plan is required before expenditure of funds (or within 60 days for interests identified mid-award).

In evaluating whether an SFI constitutes an FCOI, the Designated Official considers factors including: the nature and magnitude of the interest; the Investigator’s role in the research; whether the entity’s products or IP are being evaluated in the research; the stage of the research; and whether outcomes could affect the value of the interest.

8. Management Plans

Where an FCOI is identified, the Designated Official develops a written management plan with conditions to safeguard objectivity, and the Investigator must agree in writing to comply. Depending on the circumstances, management plan elements may include:

Public disclosure of the financial interest in all publications, presentations, and press releases resulting from the research, and written disclosure to all individuals involved in the design, conduct, or reporting of the research;
Independent review of data and analysis by a non-conflicted individual who does not report to the conflicted Investigator, with findings reported at least annually to the Designated Official;
Restrictions on the involvement of students, trainees, or interns in the affected research;
A mechanism for research team members to report concerns regarding actions of the conflicted Investigator;
Modification of the research plan, change of personnel or responsibilities, reduction or elimination of the financial interest, or severance of the relationship, where required.

Each management plan documents: the role and principal duties of the conflicted Investigator; the conditions of the plan; how the plan safeguards objectivity; confirmation of the Investigator’s agreement; and how compliance will be monitored (e.g., periodic lists of publications and presentations with disclosure language confirmed, annual reports from independent reviewers). Management plans and monitoring records are maintained in secure Company records in accordance with applicable record retention requirements.

9. Reporting to Sponsors

For NIH awards, the Designated Official submits FCOI reports through the eRA Commons FCOI Module: an initial report prior to the expenditure of funds; within 60 days for FCOIs identified during an award; and annually thereafter for the duration of the award, including status and any changes to the management plan.

For other federal awards (e.g., CDC SBIR awards), the Designated Official complies with sponsor-specific reporting requirements as specified in the Notice of Award or other sponsor guidance.

10. Subrecipients

When Armor Medical carries out PHS-funded research through a subrecipient (e.g., a collaborating health system, university, or contract research organization), the written subaward agreement must establish whether the subrecipient’s FCOI policy or Armor Medical’s policy applies to the subrecipient’s Investigators.

If the subrecipient’s policy applies, the subrecipient must certify that its policy complies with 42 CFR Part 50, Subpart F, and must report identified FCOIs to Armor Medical in time for Armor Medical to meet its reporting obligations to the sponsor.
If Armor Medical’s policy applies, the agreement must specify the time period for subrecipient Investigators to submit disclosures to Armor Medical for review.

11. Public Accessibility

This policy is posted on the Company’s public website [armormedical.us/fcoi-policy]. In addition, prior to the expenditure of funds under a PHS/NIH award, Armor Medical will make information available concerning any identified FCOI held by senior/key personnel on the project. The Company will respond to any written request for such information within five business days, providing: the Investigator’s name, title, and role in the research; the nature of the SFI; and its approximate dollar value by range (or a statement that the value cannot be readily determined). This information is updated at least annually, and within 60 days of any newly identified FCOI, and remains available for three years from the date the information was most recently updated. Written requests should be directed to compliance@armormedical.us.

12. Noncompliance, Retrospective Review, and Mitigation

Whenever an FCOI is not identified or managed in a timely manner — for example, an Investigator fails to disclose an SFI, the Company fails to review or manage a disclosed SFI, or an Investigator fails to comply with a management plan — the Designated Official will, within 60 days, implement (or update) a management plan and, within 120 days of determining noncompliance, complete and document a retrospective review of the Investigator’s activities and the research to determine whether any portion of the research was biased in its design, conduct, or reporting.

If bias is found, Armor Medical will promptly notify the sponsoring agency and submit a mitigation report describing the impact of the bias and the Company’s plan to eliminate or mitigate it. In any case involving a PHS-funded clinical project in which an Investigator with an unmanaged or unreported FCOI failed to comply with this policy, the Company will require the Investigator to disclose the FCOI in each public presentation of the research results and to request an addendum to previously published presentations.

13. Enforcement and Sanctions

Compliance with this policy is a condition of participation in Armor Medical research and, for employees, a condition of employment. The Company maintains adequate enforcement mechanisms, and violations may result in sanctions proportionate to the severity of the noncompliance, including one or more of the following:

Required immediate retraining;
Increased disclosure and monitoring requirements;
Suspension from participation in the affected research project until compliance is restored;
Removal from the project or reassignment of responsibilities;
Formal disciplinary action consistent with Company policies;
Reporting to the sponsoring agency where required by regulation or award terms.

14. Recordkeeping

Armor Medical retains all records relating to Investigator disclosures of financial interests, the Company’s review of and response to those disclosures (whether or not an FCOI was found), management plans, training certificates, and all actions under this policy or a retrospective review, for at least three years from the date the final expenditure report for the relevant award is submitted to the sponsor — or longer where required by the award terms or applicable law. Records are maintained in secure Company records in accordance with applicable record retention requirements.

15. Policy Administration

This policy is reviewed at least annually by the Designated Official and updated as needed to reflect regulatory changes or changes in Company operations. Material revisions trigger immediate Investigator retraining under Section 5. Questions regarding this policy, disclosures, or training should be directed to compliance@armormedical.us.