V 1.0

20251020

Priogen Corp.

Financial Conflict of Interest Policy

1. Purpose

Priogen Corp. (herein “Priogen) is committed to promoting objectivity in research by establishing policies and procedures that identify, manage, reduce or eliminate financial conflicts of interest (FCOIs) whenever the Institution applies for or receives funding from the PHS (or a PHS‐funding component). The design, conduct and reporting of PHS‑funded research must be free from bias resulting from an Investigator’s (as defined below) Significant Financial Interests (SFIs).

2. Applicability

This policy applies to:

• All investigators (as defined in Section 4) participating in research projects where Priogen is applying for or has received a PHS grant or cooperative agreement.

• The Institution itself, in so far as it is required to maintain the written policy, review disclosures, and make required reports to the PHS Awarding Component.

• Subrecipients (e.g., subcontractors, consortium members) engaged by Priogen under a PHS award (see Section 12).

• This policy does not apply to Phase I SBIR/STTR applications (unless PHS indicates otherwise) as permitted by the regulation.

3. Definitions

For the purposes of this policy:

• Institution means Priogen Corp.

• Investigator means the principal investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the PHS‐funded research or proposed research. For SFI disclosure purposes, “Investigator” also includes the individual’s spouse and dependent children.

• Significant Financial Interest (SFI) means a financial interest of the Investigator (or spouse/dependent children) that meets the Institution’s disclosure threshold (see Section 5). In general, SFI includes anything of monetary value, such as salary, consulting fees, honoraria, equity interests (stocks, stock options, ownership interests), intellectual property rights (e.g., patents, royalties) from outside the Institution.

• Financial Conflict of Interest (FCOI) exists when Priogen’s designated official(s) reasonably determine that the SFI:

  1. is related to PHS‐funded research (i.e., the SFI could be affected by the research or is 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 PHS‐funded research.

4. Roles and Responsibilities

• The Institution designates a FCOI Officer (or appropriate office, e.g., Office of Research Compliance) responsible for overseeing the FCOI process, including collecting disclosures, reviewing SFIs, determining FCOIs, implementing management plans, monitoring and reporting to PHS.

• Investigators are responsible for completing required disclosures and cooperating with any review, management, monitoring and reporting procedures under this policy.

• Department heads, PIs and research leadership shall support and enforce the policy, including applying any necessary enforcement actions for noncompliance.

• For subrecipients, Priogen will include appropriate terms in subaward agreements to ensure compliance (see Section 12).

5. Disclosure of Significant Financial Interests

5.1 Timing of Disclosure

• Prior to an application for PHS funding (or a revision/renewal) each Investigator must submit a written disclosure of all SFIs (investigator + spouse/dependents) that are related to the Investigator’s institutional responsibilities.

• At least annually during the period of the PHS award, each Investigator must submit an updated disclosure.

• Within 30 days of an Investigator acquiring a new SFI (e.g., through purchase, marriage, inheritance, new consulting arrangement) that meets the disclosure threshold, the Investigator must submit a supplemental disclosure.

5.2 Scope of Disclosure

• Investigators must report SFIs from both domestic and foreign entities (including income from seminars, lectures, teaching engagements, advisory committees, travel reimbursed or sponsored by foreign entities) if they meet the threshold.

• Investigators must report SFIs that are related to the Investigator’s institutional responsibilities (which include research, consultation, teaching, professional practice, institutional committees) and from entities outside Priogen (unless otherwise exempt).

5.3 Disclosure Form & Procedures

• Priogen will maintain a standardized Disclosure Form for SFIs (Appendix 1); each Investigator must complete it and submit to the FCOI Officer.

• The form will ask for: name of entity, nature of interest (e.g., equity, consulting, royalty, travel), approximate value (or dollar range), whether the entity is publicly traded, relationship to the research.

• Investigators must certify that the information is complete and accurate.

5.4 Thresholds and Exclusions

• SFIs with a minimum disclosure threshold (interests > $5,000 or ownership > 5%), consistent with the regulation’s safe‐harbor language, and all foreign SFIs and those that could reasonably appear to be related to PHS‐funded research must be reported.

• The following are not SFIs under the regulation: salary, royalties or other remuneration from Priogen; any ownership interest in Priogen if Priogen is a SBIR applicant; income from seminars/lectures or teaching engagements sponsored by a public or nonprofit entity; income from service on advisory committees or review panels for public or nonprofit entities; equity interest that meets certain value/percentage caps (though Priogen’s thresholds may be more stringent).

6. Review, Determination of FCOI and Management

6.1 Review and Determination

• Upon receipt of a disclosure, the FCOI Officer (or designated review committee) will:

  1. Determine whether the SFI is related to the PHS‐funded research (i.e., could be affected by the research or is in an entity whose financial interest could be affected by the research).

  2. If related, determine whether the SFI is a FCOI (i.e., could directly and significantly affect the design, conduct or reporting of the research).

• If a determination is made that a FCOI exists, then a management plan must be developed and implemented prior to the Institution’s expenditure of any PHS award funds for that research.

• If a new SFI is disclosed during an ongoing project, or was not timely disclosed, the review and management plan must occur within 60 days and interim measures may be required.

6.2 Management Plan

• The management plan shall specify the actions that have been, and will be, taken to manage the FCOI. Examples include:

  • Public disclosure of the FCOI (e.g., when presenting or publishing the research).

  • Disclosure of the FCOI directly to human subjects participants (if applicable).

  • Appointment of an independent monitor to oversee the project.

  • Modification of the research plan (e.g., change protocols

  • Change of personnel or responsibilities, or disqualification of the Investigator from part/all of the research.

  • Reduction or elimination of the financial interest (e.g., divestiture).

  • Severance of relationships that create the FCOI.

• The management plan must include:

  • Role and principal duties of the conflicted Investigator in the project;

  • Conditions of the management plan;

  • How the plan is designed to safeguard objectivity;

  • A statement of the Investigator’s agreement to the plan;

  • How compliance with the plan will be monitored.

• Monitoring must be ongoing for the duration of the PHS‐funded project, including extensions.

6.3 Retrospective Review & Corrective Action

• If Priogen identifies a SFI that was not disclosed timely or not managed timely, a retrospective review must be completed within 120 days of the determination of noncompliance. The review must include project number, title, Investigator name, entity, reason for review, methodology, findings, conclusions.

• If bias is found, Priogen must promptly notify the PHS Awarding Component and submit a mitigation report. The mitigation report must include the elements of the retrospective review and describe impact of bias and actions taken.

7. Public Disclosure & Recordkeeping

7.1 Public Accessibility

• Prior to the Institution’s expenditure of PHS funds for the research, Priogen must ensure public accessibility of information about any SFI held by senior/key personnel that (i) meets the disclosure threshold, (ii) is related to the PHS‐funded research, and (iii) the Institution determined to be a FCOI. That information must include: Investigator’s name; title and role in the project; entity name; nature of the SFI; approximate dollar value (via ranges) or statement that value cannot be readily determined. It must be updated at least annually and within 60 days of new FCOI identification.

• The information shall remain available for at least three years from the date the information was most recently updated.

• Priogen’s FCOI Policy shall also be posted on a publicly accessible website (www.priogen.bio, or made available upon request within five business days).

7.2 Recordkeeping

• Priogen shall maintain records of: all SFI disclosures; the Institution’s review, determination, and response to the disclosures (whether or not they resulted in FCOIs); all actions taken under this policy (including retrospective reviews). These records must be retained for at least three years from the date the final expenditures report is submitted to PHS (or longer if required by 45 CFR 75.361 or other applicable regulation).

8. Training

• Prior to engaging in PHS‐funded research, each Investigator must complete training on Priogen’s FCOI policy and on the requirements of the FCOI Regulation.

• Training must be renewed at least every four years, and immediately if: (i) the Institution revises its FCOI policy in a way that affects Investigator requirements; (ii) the Investigator is new to Priogen; or (iii) Priogen finds the Investigator to be noncompliant with the policy or a management plan.

• Priogen may use or require completion of the NIH FCOI tutorial or other approved training modules.

9. Enforcement and Sanctions

• Compliance with this policy is a condition of employment or participation in research at Priogen. Failure to comply with disclosure requirements, to cooperate with review or monitoring, or to adhere to a management plan may result in disciplinary action (up to and including removal from the project, reassignment, termination, or other appropriate institutional sanctions).

• In cases where noncompliance has biased the design, conduct, or reporting of research, Priogen will take appropriate corrective action and notify the PHS Awarding Component as required under § 50.606.

10. Reporting to the PHS Awarding Component

• Prior to the Institution’s expenditure of any funds under a PHS‐funded research project, Priogen shall provide a report to the PHS Awarding Component if it identifies a FCOI. The report must include sufficient information to allow the Awarding Component to understand the nature and extent of the FCOI and assess management plan appropriateness. Elements of the report include: project number, PI name, investigator name with FCOI, entity, nature of interest, value (via ranges), relation to the research, basis for determination, key elements of management plan (role, conditions, protections, monitoring).

• For any subsequently identified FCOIs during an ongoing project, Priogen must submit an updated FCOI report within 60 days of that determination.

• For each FCOI previously reported, Priogen must submit annual reports for the duration of the project (including extensions) to the PHS Awarding Component addressing status of the FCOI and any changes to the management plan.

11. Subrecipient Compliance

• When Priogen carries out PHS‐funded research through a subrecipient (e.g., subcontractor or consortium member), Priogen must take reasonable steps to ensure that subrecipient Investigators comply with the FCOI Regulation. This includes incorporating terms in the written agreement that specify whether the subrecipient’s own FCOI policy or Priogen’s policy applies, require certification of compliance, and allow sufficient time for disclosure, review, management and reporting to Priogen to meet the 60‑day reporting requirement.

• If the subrecipient cannot certify compliance with the subrecipient’s policy, the agreement must state that subrecipient Investigators are subject to Priogen’s FCOI policy and must make disclosures to Priogen so that Priogen may fulfill its obligations to the PHS.

12. Policy Publication & Availability

• Priogen shall maintain and enforce an up‑to‑date, written FCOI policy consistent with this Subpart and shall either post it on a publicly accessible website or, in the event the Institution does not maintain a website, make it available to any requestor within five business days.

• Priogen will provide the FCOI policy to the NIH (or other PHS Awarding Component) via the eRA Commons Institution Profile (IPF) Module, as required.

13. Policy Review and Updates

• This policy shall be reviewed at least annually by the FCOI Officer (or designee) to ensure compliance with changes in law, regulation or institutional practice. Any revisions to this policy will trigger updated Investigator training.

• Investigators will be notified when the policy is revised and may be required to complete refresher training.

14. Effective Date

This policy is effective as of 10 October 2025. It applies to all PHS‐funded research proposals submitted on or after this date and to all PHS awards currently active or future, unless otherwise required by the awarding agency.

15. Contact Information

For questions about this policy, disclosures, management plans or training, please contact:
FCOI Officer, Office of Research Compliance
Priogen Corp.
1000 Westgate Dr. Suite 9150C
612-200-2643
support@priogen.bio

Certification by Institution
By submitting any application to a PHS Awarding Component, Priogen certifies that it:

• Has in effect an up‑to‑date, written and enforced administrative process to identify and manage FCOIs with respect to all research projects for which PHS funding is sought or received.

• Will promote and enforce Investigator compliance with the requirements of the FCOI Regulation.

• Will manage FCOIs and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with the regulation.

• Will make information available promptly to HHS relating to any Investigator disclosure of financial interests and the Institution’s review and response, whether or not the disclosure resulted in a determination of FCOI.

• Will fully comply with the requirements of the regulation.

Appendix 1

Priogen Corp.

Financial Conflict of Interest (FCOI) Disclosure Policy
Required under 42 CFR Part 50, Subpart F – Promoting Objectivity in Research

SECTION 1 – Investigator Information

Field Response

Investigator Full Name

Title/Position

Department/Lab

Email Address

Phone Number

Role in PHS-funded project

☐ PI ☐ Co-Investigator ☐ Other: ___________

Project Title

PHS Awarding Component

☐ NIH ☐ CDC ☐ FDA ☐ Other: ___________

SECTION 2 – Significant Financial Interest (SFI) Disclosure

Please disclose all Significant Financial Interests (SFI) that are related to your institutional responsibilities and/or could be affected by your PHS-funded research. Provide separate entries for each entity.

SFI means:

·         Remuneration or equity interest in a publicly traded entity exceeding $5,000 in the past 12 months.

·         Any equity interest (regardless of amount) in a non-publicly traded entity.

·         Any income from intellectual property rights (e.g., patents, royalties).

·         Sponsored or reimbursed travel from foreign or for-profit entities.

·         Interests held by your spouse or dependent children.

Use additional pages if needed.

Name of External Entity

Nature of Interest (e.g., equity, consulting, royalties, travel)

Approximate Dollar Value (check one)

☐ < $5,000 ☐ $5K–$9.9K
☐ $10K–$19.9K
☐ $20K–$49.9K
☐ $50K–$99.9K
☐ $100K+
☐ Cannot determine

Publicly Traded?

☐ Yes ☐ No

Describe Relationship to PHS-Funded Research

SECTION 3 – Additional Information

If applicable, describe how the financial interest might relate to or affect the design, conduct, or reporting of the PHS-funded research:

 SECTION 4 – Investigator Certification

By signing below, I certify that:

• The information I have provided is true, complete, and accurate to the best of my knowledge.

• I have read and understand Priogen Corp.’s Financial Conflict of Interest Policy.

• I agree to comply with any requirements to manage, reduce, or eliminate any FCOI identified.

• I will submit an updated disclosure:
  ☐ At least annually,
  ☐ Within 30 days of discovering or acquiring a new SFI, and
  ☐ As otherwise required by Priogen Corp. or the PHS Awarding Component.

Investigator Signature Date

 SECTION 5 – Review by FCOI Official (Internal Use Only)

Date Received

Reviewed By

FCOI Determination

☐ Yes ☐ No

If FCOI Determined:

·         ☐ Management Plan Required

·         Date Management Plan Implemented: ___________

·         Public Disclosure Required? ☐ Yes ☐ No

·         Reported to PHS? ☐ Yes ☐ No ☐ N/A