Financial Conflict of Interest Policy

Immersive Tech Inc.

Last Updated: November 7, 2024

Purpose:

This FCOI policy documents the process for identifying and managing financial conflicts of interest, ensuring the integrity of NIH-funded research at Immersive Tech Inc. It aligns with the Regulations (42 CFR Part 50 Subpart F) and adheres to the 2011 Revised Financial Conflict of Interest Regulation, which mandates standards for unbiased research design, conduct, and reporting under NIH grants or agreements. Immersive Tech Inc. must enforce an FCOI policy that meets regulatory requirements to be eligible for NIH funding. The regulation is available at http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf.

Definitions:

These definitions are essential for understanding FCOI federal regulations. For official definitions, refer to 42 CFR 50.603.

Investigator – means the project director or principal investigator and any other person, regardless of title or position, who is or will be responsible for the design, conduct, or reporting of research funded by the NIH, which may include, for example, collaborators or consultants.

Institution – means any domestic or foreign, public, or private, entity or organization (excluding a federal agency) applying for or receiving NIH research funding.

Financial conflict of interest (FCOI) – means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of NIH-funded research.

Significant Financial Interest (SFI) – means:

1. 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 (company) responsibilities:
   1. 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
   2. 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); or
   3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests in excess of $5,000.
2. Investigators also must disclose the occurrence of any reimbursed or sponsored travel in excess of $5,000 related to their company responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by Federal, state, or local government agency located in the United States, an United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an United States institution of higher education.

Note: Reimbursed or sponsored travel from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income is more than $5,000. The details of the disclosure will include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

1. The term significant financial interest does not include the following types of financial interests:
   1. salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution
   2. intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights
   3. any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization
   4. 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
   5. 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 United States institution of higher education
   6. income from any 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.

Note: Income from seminars, lectures, or teaching engagements and from service on advisory committees or review panels received from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income meets the threshold for disclosure.

Responsibilities – means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution, including but not limited to, activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

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

Manage – means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

Senior/Key Personnel – means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the NIH by the Institution under the regulation.

Procedure:

1. Training Requirements
   1. Investigators involved in NIH-funded research must know Immersive Tech Inc.'s FCOI policy, the relevant federal regulations (42 CFR Part 50 Subpart F), and their disclosure obligations. The Principal Investigator must identify all Investigators with disclosable SFIs and ensure the submission of an SFI Disclosure Form.
   2. Investigators must complete training on 42 CFR Part 50 Subpart F and Immersive Tech Inc.'s FCOI policy before starting NIH-funded research, every four years, and immediately if the company's FCOI policy changes, if they are new to the company, or if they breach the FCOI policy or management plan.
   3. Training requires Investigators to acknowledge they've read:
      1. Immersive Tech Inc.'s FCOI Policy.
      2. NIH's FCOI tutorial on 42 CFR Part 50 Subpart F, necessary for all involved in NIH-funded projects. Certificates of completion should be filed in the company's records. Training is mandated before any NIH-funded research begins, after FCOI policy updates, upon non-compliance, or when joining the company, and must be repeated every three years. The course can be accessed online at any time by visiting:http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
   4. The FCOI Policy implementation includes:
      1. Providing a written copy to each Investigator.
      2. Adding the policy to the company's secure shared drive and a public website.
2. Disclosure, Review, and Monitoring Requirements
   1. Investigators must report SFIs (including those of their spouses and dependent children) that are pertinent to their institutional duties and meet or surpass the SFI criteria established by this policy, through the company's Significant Financial Interest Form:
      1. At the NIH-funded research application stage
      2. Annually throughout the award duration

• Within 30 days of identifying or obtaining a new SFI.

1. The CEO of Immersive Tech Inc., serving as the designated institutional official, is tasked with eliciting and evaluating SFI disclosures from Investigators (and those of the Investigator's family) connected to their institutional duties to ascertain any FCOIs.
   1. An SFI Is related to NIH-funded research if the CEO deems that it:
      1. Might be influenced by the NIH-funded research; or
      2. Belongs to an entity that could be impacted financially by the research.
   2. Investigators may participate in determining the relevance of the SFI to NIH-funded research.

• An FCOI is present if the CEO believes that the SFI could notably sway the NIH-funded research's design, conduct, or reporting. In such cases, appropriate actions will be considered based on the SFI Disclosure Form, potentially necessitating a management plan that specifies the terms and conditions to adhere to this policy (refer to Enforcement Mechanisms).

1. Should an SFI be identified as an FCOI, the company will manage it at its discretion, which might include public disclosure, the appointment of an independent monitor, modifications to the research plan, or the Investigator's removal from the NIH-funded research.
2. Before utilizing any NIH funds, the CEO is required to:
   1. Assess all SFI disclosures from Investigators
   2. Decide whether any SFIs relate to the NIH-funded research

• Ascertain the existence of any FCOIs and, if they exist,

1. Formulate and enforce a management plan to address the FCOIs.
2. Should a new Investigator join, or an existing Investigator report a new SFI in an NIH-funded research project, the CEO must, within 60 days, evaluate the SFI disclosures, ascertain the presence of an FCOI, and if one is found, initiate a management plan outlining the measures taken and to be taken to address the FCOI.
3. If the company discovers an SFI that an Investigator did not disclose in a timely manner or that the company has not previously assessed during an ongoing NIH-funded research project, the CEO is required to, within 60 days, review the SFI disclosures, decide if an FCOI is present, and if affirmative, implement a management plan detailing the actions undertaken and those planned for future management of the FCOI.
4. The company is tasked with overseeing FCOIs for all Investigators, including those of a subrecipient Investigator, ensuring adherence to management plans until the research project is concluded.
5. Reporting Requirements to NIH
   1. Immersive Tech Inc. is required to submit initial, yearly, and updated FCOI reports containing all details mandated by 42 CFR Part 50 Subpart F to the NIH through the eRA Commons FCOI Module for both the Institution and its subrecipients, where relevant, as outlined below:
      1. Before using any funds
      2. Within 60 days of discovering an FCOI for an Investigator who is new to the project

• Within 60 days upon finding new or previously unidentified FCOIs for current Investigators

1. Annually, concurrent with the submission of the annual progress report, detailing the FCOI's status and any modifications to the management plan until the project's conclusion
2. Following a retrospective review to amend an earlier report if additional information comes to light after the review is completed.
3. Immersive Tech Inc. is obligated to immediately inform NIH if any bias is detected in the design, execution, or reporting of NIH-funded research. A Mitigation Report will be provided to outline steps taken to counteract the impact of the bias in line with 42 CFR Part 50 Subpart F. The report will include all required components such as the entity name, the Investigator with the FCOI, the nature and value of the SFI(s), among others, as specified by 42 CFR Part 50 Subpart F.
4. Immersive Tech Inc. must immediately inform NIH if an Investigator breaches Immersive Tech Inc.'s FCOI policy or if there's evidence suggesting that an FCOI management plan may have skewed the design, execution, or reporting of NIH-funded research. The company is responsible for implementing necessary corrective measures in response to any such noncompliance or influence on research outcomes.
5. Maintenance of Records
   1. Immersive Tech Inc. shall preserve all records pertaining to Investigator financial interest disclosures, and the company's examination and response to these disclosures—irrespective of whether a disclosure led to an FCOI determination—along with all proceedings in accordance with the company's policy or retrospective analysis, as applicable:
      1. For a minimum of 3 years following the submission date of the final expenditure report to the NIH.
      2. Or, if relevant, from dates delineated in 45 CFR 75.361.
6. Enforcement Mechanisms and Remedies and Noncompliance
   1. To manage, mitigate, or eradicate actual or potential conflicts of interest, the management plan might necessitate various actions, including but not limited to:
      1. Making significant financial interests known to the public.
      2. Independent evaluation of research protocols.

• Independent oversight of the research.

1. Altering the research strategy.
2. Prohibiting participation in part or all of the funded research.
3. Selling off significant financial interests.

• Cutting ties that pose actual or potential conflicts.

All management strategies must be endorsed by both the Investigator and Immersive Tech Inc.'s CEO.

Should an Investigator fail to adhere to the FCOI policy or management plan of Immersive Tech Inc., disciplinary or administrative measures will be enforced, which could include a formal reprimand, restrictions on fund usage, forfeiture of compensation, or dismissal.

1. If there is noncompliance due to untimely disclosure or management of an SFI or an FCOI, Immersive Tech Inc. will conduct a retrospective assessment within 120 days to address:
   1. Non-disclosure of a significant financial interest by the Investigator which the company deems to be an FCOI.
   2. The company's failure to evaluate or manage an FCOI.

• The Investigator's non-compliance with the FCOI management plan.

1. The retrospective review will be documented and will include, at minimum, the following:
   1. Project number
   2. Project title

• PD/PI and contact information

1. Name of Investigator with the FCOI
2. Name of the entity with which the Investigator has an FCOI
3. Reasons for the retrospective review

• Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed)
• Findings of the review

1. Conclusions of the review.
2. If a project funded by NIH involves clinical research evaluating the safety or effectiveness of technology from Immersive Tech Inc. and is designed, conducted, or reported by an Investigator with an FCOI not managed or reported as mandated by 42 CFR Part 50 Subpart F, Immersive Tech Inc. will mandate that the Investigator:
   1. Reveal the FCOI in all public disclosures of the research findings.
   2. Seek an amendment to any previously published presentations of the research.
3. Subrecipient Requirements
   1. When applicable, Immersive Tech Inc. will comply with all subrecipient requirements according to 42 CFR 50.604(c) and NIH Grants Policy Statement 15.2.1.
   2. Immersive Tech Inc. will determine through a formal agreement if the subrecipient will adopt Immersive Tech Inc.'s FCOI policy or their own. If the subrecipient's policy is adopted:
      1. Immersive Tech Inc. will acquire confirmation that the subrecipient's FCOI policy is consistent with 42 CFR Part 50 Subpart F
      2. Immersive Tech Inc. will mandate in the subrecipient contract that the subrecipient must promptly report any FCOIs of its Investigators to enable the company to fulfill reporting obligations to the NIH as dictated by 42 CFR Part 50 Subpart F

• As an alternative, Immersive Tech Inc. will include a provision in the subrecipient contract obligating the subrecipient to submit and allow review of Investigator disclosures, assisting the company in identifying, managing, and reporting FCOIs to the NIH.

1. Public Accessibility Requirements

Immersive Tech Inc.'s will store the FCOI Policy on a publicly available website. The policy will:

1. Include 42 CFR Part 50 Subpart F's minimum elements.
2. Be accessible within 5 business days upon request
3. Be updated annually, with current information provided upon request
4. Be revised within 60 days following the identification of a new FCOI, with current information provided upon request
5. Remain available for 3 years after the latest update.