Financial Conflict of Interest Policy

Purpose

This policy promotes objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded by the National Institutes of Health (NIH) at panluminate, Inc. ("panluminate") are not biased by any conflicting financial interest of an Investigator.

Who is an Investigator?

For purposes of this policy, "Investigator" means the Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by NIH. At panluminate, the designated Investigator is:

Ons M'Saad, PhD
Founder & CEO, Principal Investigator

This definition may be expanded as the research team grows. The CEO will notify any newly designated Investigators in writing.

Significant Financial Interest (SFI)

An SFI exists when an Investigator (or their spouse or dependent children) has a financial interest in an entity that reasonably appears related to the Investigator's institutional responsibilities, including:

• Remuneration (salary, consulting fees, honoraria) exceeding $5,000 in the prior 12 months
• Equity interest (stock, stock options, other ownership interest) in a non-publicly traded entity
• Intellectual property rights (patents, royalties) not assigned to panluminate

SFIs do not include salary from panluminate, income from seminars or teaching, equity in publicly traded entities below $5,000, or retirement accounts over which the Investigator has no control.

Disclosure requirements

Annual disclosure. The Investigator must submit a complete disclosure of all SFIs to the CEO at least annually. Disclosures are made on the FCOI Disclosure Form and filed in the company's compliance records.

Onboarding disclosure. Before beginning any NIH-funded research, the Investigator must complete an initial FCOI disclosure.

30-day update requirement. The Investigator must update their disclosure within 30 days of acquiring or discovering any new SFI, for example a new consulting arrangement, receipt of equity, or issuance of a patent.

Review and determination

The CEO, acting as the Authorized Organizational Representative (AOR) and Designated Institutional Official, is responsible for reviewing all FCOI disclosures. The review process is as follows:

1. The CEO reviews the disclosure within 60 days of submission or before NIH funds are spent, whichever is earlier.
2. The CEO determines whether an SFI is related to NIH-funded research.
3. If it is related, the CEO determines whether the SFI constitutes a financial conflict of interest, meaning whether it could directly and significantly affect the design, conduct, or reporting of the research.
4. If a conflict is identified, the CEO implements a management plan, which may include public disclosure, modification of the research plan, monitoring of the research by independent reviewers, or disqualification from participation in relevant research activities.

All determinations and management plans are documented and retained.

Reporting to NIH

panluminate will report any identified FCOI to the NIH Grants Management Specialist within 60 days of identification, and annually thereafter, in the format required by NIH. If an FCOI is not identified or managed in a timely manner, panluminate will take corrective action and report retroactively as required.

Recordkeeping

All FCOI disclosures, review records, determinations, and management plans are retained for at least three years following the submission of the final expenditure report for the relevant award, or longer if required by other applicable regulations.

Contact

Questions about this policy can be sent to info@panluminate.com or by mail to panluminate, Inc., 55 Church Street #100B, New Haven, CT 06510.