1Purpose

Cognixion Corporation (“Cognixion” or the “Company”) is committed to maintaining the objectivity and integrity of the research it conducts. As a recipient of research funding from the Public Health Service (PHS), including the National Institutes of Health (NIH), Cognixion must ensure that the design, conduct, and reporting of that research are free from bias caused by any conflicting financial interest of an Investigator.

This Policy establishes the standards and procedures Cognixion uses to identify, evaluate, manage, reduce, or eliminate Financial Conflicts of Interest (FCOIs). It is intended to comply with the U.S. Department of Health and Human Services (HHS) regulation “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought,” 42 CFR Part 50, Subpart F, and the corresponding requirements for contracts at 45 CFR Part 94, as those regulations may be amended.

2Scope and Applicability

This Policy applies to every Investigator (as defined below) who is planning to participate in, or is participating in, research funded or proposed for funding by the PHS or any PHS component, whether through a grant, cooperative agreement, or contract, and whether Cognixion is the direct recipient or a subrecipient.

Consistent with the regulation, this Policy does not apply to Phase I Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications and awards. It does apply to Phase II SBIR/STTR awards (including Fast-Track and Direct-to-Phase II awards such as the R44) and to all other non-exempt PHS awards.

Cognixion may, at its discretion, apply the disclosure and review principles of this Policy to research funded by other sponsors (federal, state, foundation, or industry) as a matter of good scientific governance.

3Regulatory Authority

This Policy implements the requirements of 42 CFR Part 50, Subpart F (“Promoting Objectivity in Research”) and 45 CFR Part 94 (“Responsible Prospective Contractors”). Where any provision of this Policy conflicts with, or is less stringent than, those regulations or the NIH Grants Policy Statement, the regulations and the NIH Grants Policy Statement shall control.

4Definitions

Designated Official

means the individual whom Cognixion has designated to solicit and review disclosures of Significant Financial Interests, to determine whether an FCOI exists, and to implement, monitor, and report management plans. For purposes of this Policy, the Designated Official is Nicholas Behrman, General Counsel. The Designated Official must be a person other than the Investigator whose disclosure is under review; where the Designated Official is also an Investigator on a project, the review of that person’s own disclosures shall be conducted by Andreas Forsland, CEO (the “Alternate Reviewer”).

Financial Conflict of Interest (FCOI)

means a Significant Financial Interest that Cognixion reasonably determines could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest

means anything of monetary value, whether or not the value is readily ascertainable.

HHS

means the U.S. Department of Health and Human Services, and any component or successor.

Institutional Responsibilities

means an Investigator’s professional responsibilities on behalf of Cognixion, including but not limited to research, research consultation, product and technology development, and service on Company or external committees and panels.

Investigator

means the project director or principal investigator and any other person, regardless of title or position (including employees, officers, and, where appropriate, consultants, contractors, and collaborators), who is responsible for the design, conduct, or reporting of PHS-funded research, or of a proposal for such funding. Investigators are not limited to persons listed as “key personnel.”

Investigator’s Family / Immediate Family

means the Investigator’s spouse and dependent children.

Manage

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

NIH

means the National Institutes of Health, a component of the PHS.

PD/PI

means a project director or principal investigator of a PHS-funded research project.

PHS

means the Public Health Service of HHS, and any components to which the authority of the PHS may be delegated, including the NIH, CDC, FDA, HRSA, AHRQ, and others.

PHS Awarding Component

means the organizational unit of the PHS that funds the research (for example, the National Institute on Deafness and Other Communication Disorders, NIDCD).

Research

means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge, including basic and applied research and product development, for which PHS funding is available.

Significant Financial Interest (SFI)

means a Financial Interest of an Investigator (and, when aggregated, those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities and that consists of one or more of the following:

1. Publicly traded entity — remuneration received from the entity in the twelve (12) months preceding the disclosure and the value of any equity interest as of the date of disclosure, where the aggregate value of remuneration plus equity exceeds $5,000. Remuneration includes salary and any payment for services (e.g., consulting fees, honoraria, paid authorship). Equity includes stock, stock options, or other ownership interest.
2. Non-publicly traded entity — (i) remuneration received in the preceding twelve (12) months that exceeds $5,000 in the aggregate; or (ii) any equity interest of any value (e.g., stock, stock option, or other ownership interest).
3. Intellectual property rights — income of any amount received from intellectual property rights and interests (e.g., patents, copyrights) and royalties from such rights, upon receipt of such income, when not paid to the Investigator through Cognixion.
4. Sponsored or reimbursed travel — the occurrence of any reimbursed or sponsored travel undertaken by the Investigator and related to his or her Institutional Responsibilities (see Section 7.4).

An SFI does not include:

• Salary, royalties, or other remuneration paid by Cognixion to the Investigator, if the Investigator is currently employed or otherwise appointed by Cognixion (see Section 4.1 regarding ownership interests in Cognixion itself);
• Income from the authorship of academic or scholarly works;
• 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, or from advisory committees or review panels for, a U.S. federal, state, or local government agency; a U.S. institution of higher education; an academic teaching hospital; a medical center; or a research institute affiliated with an institution of higher education.
• Excluded travel: travel that is reimbursed or sponsored by a U.S. federal, state, or local government agency; a U.S. institution of higher education; an academic teaching hospital; a medical center; or an affiliated research institute.

4.1  Ownership Interests in Cognixion (Small-Business Context)

Because Cognixion is a small business whose Investigators may be founders, officers, employees, or option holders, an Investigator’s equity or ownership interest in Cognixion itself is inherent to participation in the Company. Salary and other remuneration paid by Cognixion are excluded from the definition of SFI above. An Investigator’s ownership or equity interest in Cognixion (including founder shares and stock options) must nonetheless be disclosed under this Policy. The Designated Official (or Alternate Reviewer) will determine whether such an interest is related to the PHS-funded research and constitutes an FCOI and, if so, will implement a management plan. Because equity in a small business ordinarily cannot be divested without defeating the purpose of the SBIR/STTR program, management of such interests will typically emphasize oversight, transparency, and independent review rather than elimination of the interest.

5Roles and Responsibilities

5.1  Designated Official

The Designated Official, or their delegate, is responsible for administering this Policy, including: distributing the Policy and disclosure forms; soliciting, receiving, and reviewing SFI disclosures; determining whether an SFI is related to PHS-funded research and whether it is an FCOI; developing, implementing, and monitoring management plans; making required reports to the PHS Awarding Component; overseeing training; maintaining records; and responding to requests for public accessibility information.

5.2  Investigators

Each Investigator is responsible for reading and complying with this Policy; completing required training; disclosing SFIs completely, accurately, and on time; cooperating with the review process; and complying with any management plan. Investigators must not expend PHS funds on affected research until any required disclosure has been reviewed and any required management plan is in place.

6Investigator Training

Each Investigator must complete training on this Policy, on the Investigator’s disclosure responsibilities, and on the PHS FCOI regulation before engaging in research funded by the PHS, and at least every four (4) years thereafter. Investigators must also complete training within a reasonable period of time as determined by the Designated Official when any of the following occurs:

• This Policy is revised in a manner that affects Investigator requirements;
• An Investigator is new to Cognixion; or
• An Investigator is found not to have complied with this Policy or with a management plan.

Cognixion may satisfy the regulatory training requirement using the NIH FCOI tutorial and will supplement it with training on this Policy and Cognixion’s disclosure procedures. Completion of training will be documented and retained. The NIH FCOI training module is available at grants.nih.gov/grants/policy/coi.

7Disclosure of Significant Financial Interests

Investigators disclose SFIs to Cognixion — not only those that appear related to a specific project. The Designated Official, not the Investigator, determines relatedness and whether an FCOI exists.

7.1  Disclosure at the Time of Application

Each Investigator who is planning to participate in PHS-funded research must submit a completed SFI disclosure, using the form provided by the Designated Official, no later than at the time of application for PHS-funded research.

7.2  Annual Disclosure

Each Investigator must submit an updated SFI disclosure at least annually during the period of any PHS award. The annual disclosure must include any information that was not disclosed initially, or that has changed, and must be current as of the date of submission.

7.3  Ongoing (Ad Hoc) Disclosure

Each Investigator must submit an updated disclosure within thirty (30) days of discovering or acquiring a new SFI (for example, through employment, new equity, new consulting income, or a gift).

7.4  Travel Disclosure

Each Investigator must disclose reimbursed or sponsored travel related to his or her Institutional Responsibilities (subject to the exclusions in Section 4). At a minimum the disclosure must state the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration. The Designated Official will determine whether additional information (including monetary value) is needed and whether the travel constitutes an FCOI.

8Institutional Review and Determination of FCOI

Upon receiving a disclosure, the Designated Official (or Alternate Reviewer, where applicable) will:

1. Determine whether a disclosed SFI is related to the PHS-funded research — that is, whether the research could affect the financial interest, or whether the SFI is in an entity whose financial interest could be affected by the research; and
2. If related, determine whether the SFI is an FCOI — that is, whether it could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

This review will occur, and any management plan will be in place, before Cognixion expends any funds under a PHS award; before a new Investigator participates in ongoing research; and within sixty (60) days of an Investigator’s disclosure of a new or newly identified SFI during an award.

9Management of Financial Conflicts of Interest

If the Designated Official determines that an FCOI exists, Cognixion will develop and implement a written management plan before any related PHS-funded research goes forward. The affected Investigator must review, agree to, and sign the management plan. The plan will specify the conditions or restrictions imposed and how they will be monitored for the duration of the award. Depending on the circumstances, conditions may include one or more of the following:

• Public disclosure of the FCOI (e.g., in presentations and publications of the research);
• For research involving human subjects, disclosure of the FCOI directly to participants;
• Appointment of an independent monitor or reviewer capable of taking measures to protect the design, conduct, and reporting of the research against bias;
• Modification of the research plan;
• Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
• Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
• Severance of relationships that create the conflict.

The Designated Official will monitor Investigator compliance with the management plan on an ongoing basis until completion of the PHS-funded research.

10Reporting to the PHS Awarding Component

Prior to Cognixion’s expenditure of any funds under a PHS award, and consistent with 42 CFR 50.605(b), the Designated Official will provide an FCOI report to the PHS Awarding Component (via the NIH eRA Commons FCOI Module) for each identified FCOI, and will thereafter submit reports as required, including:

• An initial FCOI report before expenditure of funds and, for FCOIs identified during an award, within sixty (60) days of identification;
• An annual FCOI report for the duration of the award, submitted at the same time as the annual progress report or otherwise as required, that addresses the status of the FCOI and any changes to the management plan; and
• Revised or updated reports following any retrospective review that changes a prior report.

Each FCOI report will include the elements required by the regulation, such as: the project number and title; the PD/PI or contact PD/PI; the name of the Investigator with the FCOI; the name of the entity in which the SFI is held; the nature of the SFI; the approximate dollar value of the SFI (in ranges permitted by the regulation, or a statement that the value cannot be readily determined); a description of how the SFI relates to the research; and a description of the key elements of the management plan.

11Subrecipients, Subcontractors, and Consultants

When Cognixion carries out PHS-funded research through a subrecipient, subcontractor, or consultant (including academic collaborators and Investigators who are not Cognixion employees), Cognixion will take reasonable steps to ensure compliance through a written agreement that:

• Specifies whether this Policy or the subrecipient’s own FCOI policy will apply to the subrecipient’s Investigators;
• If the subrecipient’s policy applies, requires the subrecipient to certify that its policy complies with 42 CFR Part 50, Subpart F, and to report identified FCOIs to Cognixion in sufficient time for Cognixion to report them to the PHS Awarding Component;
• If this Policy applies, specifies the time period for the subrecipient’s Investigators to submit disclosures to Cognixion; and
• Establishes time periods that enable Cognixion to meet its own reporting obligations to the PHS Awarding Component.

12Retrospective Review and Mitigation

Whenever an FCOI is not identified or managed in a timely manner — including an Investigator’s failure to disclose an SFI that is determined to be an FCOI, failure to comply with a management plan, or an SFI that is not reviewed or managed in time — the Designated Official will, within one hundred twenty (120) days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research to determine whether the research conducted during the period of noncompliance was biased in its design, conduct, or reporting.

Documentation of the retrospective review will include, at minimum: the project number and title; the PD/PI; the name of the Investigator and of the entity in which the FCOI is held; the reason(s) for the review; the detailed methodology used; and the findings and conclusions. If the retrospective review determines that bias was present, Cognixion will promptly notify the PHS Awarding Component and submit a mitigation report that describes the impact of the bias on the research and the plan of action to eliminate or mitigate its effect.

13Noncompliance and Enforcement

Compliance with this Policy is a condition of participation in PHS-funded research at Cognixion. If an Investigator fails to comply with this Policy or with a management plan, the Designated Official may take remedial or disciplinary action appropriate to the circumstances, which may include additional training, revision or intensification of the management plan, suspension of the Investigator’s participation in the affected research, suspension of expenditures, or other action consistent with Cognixion’s employment policies and applicable law.

Where sanctions are imposed, the Investigator will receive a written explanation and will be informed of any right to respond or appeal. Cognixion will notify the PHS Awarding Component of any action taken or to be taken, as required by the regulation, and will comply with any additional agency requirements, including enforcement or corrective actions specified by the PHS Awarding Component.

14Recordkeeping and Record Retention

Cognixion will maintain records of all Investigator disclosures, of the Designated Official’s determinations, of management plans, of monitoring activities, of training completion, and of all reports to the PHS Awarding Component. These records will be retained for at least three (3) years from the date the final expenditure report is submitted to the PHS (or, for a subrecipient, from the date Cognixion submits the final expenditure report to the prime awardee), or longer if required by 45 CFR Part 75, by other applicable regulation, or by any ongoing litigation, claim, audit, or government action, until its resolution.

15Confidentiality

To the extent permitted by law, Cognixion will treat SFI disclosures, management plans, and related records as confidential. Cognixion may nonetheless disclose such information as required to the PHS Awarding Component or HHS, to a requestor of public-accessibility information as described in Section 16, or to a prime awardee where Cognixion is a subrecipient. Where Cognixion is required to release such information to an external entity, it will inform the affected Investigator.

16Public Accessibility

Cognixion posts this Policy on a publicly accessible website at https://www.cognixion.com/fcoi.

Prior to Cognixion’s expenditure of funds under a PHS award, and consistent with 42 CFR 50.605(a)(5), Cognixion will respond within five (5) business days to any requestor seeking information about an SFI that meets all of the following criteria, and the information provided will remain available for the required period and be updated as required:

1. The SFI was disclosed and is still held by an Investigator who is senior or key personnel on the PHS-funded project;
2. Cognixion has determined that the SFI is related to the PHS-funded research; and
3. Cognixion has determined that the SFI is an FCOI.

The information made available will be limited to that required by the regulation (e.g., the Investigator’s name and title, the nature and approximate dollar-range value of the SFI, and its relationship to the research).

17Effective Date and Revisions

This Policy is effective as of July 13, 2026. Cognixion will review this Policy periodically and revise it as necessary to maintain compliance with 42 CFR Part 50, Subpart F, 45 CFR Part 94, and the NIH Grants Policy Statement. Material revisions may trigger a requirement for Investigators to complete updated training under Section 6.

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