Privacy and FCOI Policy

PRIVACY POLICY

Effective Date: 07-01-2020

VitaKey is committed to protecting your privacy. This Privacy Policy (“Privacy Policy”) discloses the privacy practices of VitaKey (“VitaKey,” “we”, “us” or “our”) with respect to our data collection practices, including on our website at https://vitakey.com/ and mobile website, linked or otherwise connected thereto (collectively, the “Site”).

Please read this privacy policy carefully as it constitutes a legally binding agreement between you and VitaKey that conditions your use of the Site. By using, accessing, or downloading a site, you signify your acceptance of this Privacy Policy.

What Information Do We Collect and How Do We Use It?

We do not collect any Personal Information other than as described below. For the purposes of this Privacy Policy, “Personal Information” means information that identifies, relates to, describes, is reasonably capable of being associated with, or could be reasonably linked, directly or indirectly, with a particular consumer, device or household. It does not include de-identified or aggregate information, or public information lawfully available from governmental records.

Information Automatically Collected

When you visit our Site, we automatically collect your IP address, browser, and device characteristics, operating system, language preferences, referring URLs, device name, country, location, information about how and when you use the Site and other technical information. However, this information does not reveal your specific identity, but is needed to operate and maintain the security of the Site, and for our internal analytics and reporting purposes.

How Do We Share Information?

We do not share Personal Information with anyone, except to comply with the law, develop our products, and protect our rights.

Third Party Vendors

We enter into contractual arrangements with affiliates, services providers, partners, and other third parties. We and our affiliates, services providers, partners, and other third parties may use your information to operate our Site.

Legal Process, Security, Defense, Protection

Occasionally, we may be required to share information with third parties for legitimate business purposes, or to comply with legal obligations. For example, we may share information when we believe in good faith that an applicable law requires it; at the request of law enforcement, judicial authorities (e.g. upon receipt of a court order or subpoena), appropriate governmental authorities; to detect and protect against fraud, or any technical or security vulnerabilities; to respond to an emergency; or otherwise to protect the rights, property, safety or security of third parties, visitors to our Site, our businesses, or the public.

Change in Control or Sale

If VitaKey sells all or part of its business or the equity ownership thereof, makes a sale or transfer of all or a material part of its assets, or is otherwise involved in a merger, reverse merger, or transfer of all or a material part of its business, VitaKey may disclose and transfer your information to the party or parties involved in the transaction as part of that transaction.

Changes

We reserve the right to revise this Privacy Policy at any time by amending this page and changes will be effective upon being posted unless we advise otherwise. If we make any material changes to this Privacy Policy we will notify you by means of a notice on our Site prior to the change becoming effective. By continuing to use the Site after changes are made to this Privacy Policy, you agree to such changes. If you do not accept the terms of this Privacy Policy, we ask that you exit our Site immediately.

Contact and Exercising Your Privacy Rights

If you have questions on the processing of your Personal Information, would like to exercise any of your rights, or have a complaint, please contact us here: info@vitakey.com or +1 -833-VITAKEY.

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FCOI POLICY

Effective Date: 09-05-2025

Document #: CP0020

Revision #: D

1.0 Purpose and Scope

The purpose of this policy is to ensure that research funded by the National Institutes of Health (NIH) is designed, conducted, and reported objectively and without bias resulting from Investigator ﬁnancial conﬂicts of interest (FCOI). The regulations are 42 CFR Part 50 Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective Contractors”, which set requirements for promoting objectivity in Public Health Service (PHS)–funded research for grants, cooperative agreements, and research contracts. The regulations do not apply to SBIR or STTR Phase I applications or awards. This policy implements the regulatory requirements for PHS/NIH grants and cooperative agreements.

VitaKey, Inc. adopts this policy for all Investigators (as deﬁned below) engaged in PHS/NIH-funded research. It establishes processes to identify, disclose, and manage Investigator ﬁnancial conﬂicts of interest to protect research integrity, ensure the safety of human and animal subjects, and maintain public trust in PHS/NIH-supported research.

2.0 Applicability

This policy implements the regulatory requirements provided in 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the NIH. This policy applies to all Investigators who are responsible for the design, conduct, or reporting of NIH-funded research at VitaKey. It also applies to “Investigators” who participate as employees, subcontractors, or collaborators on NIH-funded projects.

3.0 Definitions

Financial conflict of interest (FCOI): A signiﬁcant ﬁnancial interest that is related to the PHS/NIH- funded research (i.e., the SFI could be affected by the research or the SFI is in an entity whose ﬁnancial interest could be affected by the research) and could directly and signiﬁcantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest: Anything of monetary value, whether or not its value is readily ascertainable.

Institutional Responsibilities: The professional activities an Investigator performs on behalf of VitaKey including research, product development and testing, publication and communication of research, consulting, operations management, administration, fundraising, and institutional committee memberships or panels.

Investigator: The Project Director (PD) or Principal Investigator (PI), and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS/NIH or proposed for such funding. This may include, for example, collaborators or consultants. VitaKey determines who is responsible for the design, conduct, or reporting of PHS/NIH-funded research based on an individual’s role and level of independence, not their title.

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.

Research: A systematic investigation, study, or experiment designed to develop or contribute to general knowledge relating broadly to public health, including biomedical research. This term includes both basic and applied research (e.g., published articles, books, or book chapters) and product development (e.g., diagnostic devices or analytical instruments).

PHS-Funded Research: Any activity supported by a Public Health Service (PHS) Awarding Component through a grant, cooperative agreement, or contract, whether funded under the PHS Act or other statutory authority.

PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

NIH: The biomedical research agency within the Public Health Service (PHS) that funds and conducts research to improve health and advance scientiﬁc knowledge.

Senior/Key Personnel: The PD/PI and any other individual identiﬁed as senior/key personnel by VitaKey in a grant application, progress report, or other submission to PHS/NIH. For this policy, the term applies speciﬁcally to the public accessibility requirement, which mandates disclosure only of ﬁnancial conﬂicts of interest held by these senior/key personnel, as described in Section 9.

Significant Financial Interest (SFI):
1. A domestic or foreign ﬁnancial interest consisting of one or more of the following interests of the of the Investigator, and those of the Investigator’s spouse, and dependent children, that reasonably appears to be related to the Investigator’s institutional responsibilities (e.g., research, product development and testing, publication and communication of research, consulting, operations management, administration, fundraising, and institutional committee memberships or panels) performed on behalf of VitaKey, and that consists of one or more of the following:
a. Publicly traded entity: An SFI exists if the total of remuneration received from the entity in the previous 12 months and the value of any equity interest in the entity on the disclosure date exceeds $5,000. Remuneration includes salary and payments for services (e.g., consulting fees, honoraria, paid authorship). Equity interest includes stock, stock options, or other ownership interests measured by public prices or other reasonable market value.
b. Non-publicly traded entity: An SFI exists if the aggregated value of remuneration received from the entity in the 12 months preceding the disclosure exceeds $5,000, or if the Investigator (or their spouse or dependent children) holds any equity interest in the entity (e.g., stock, stock options, or other ownership interest).
c. Intellectual property: An SFI exists if receipt of income related to intellectual property rights or interests (e.g., patents, copyrights), exceeds $5,000 during the 12 months preceding the disclosure, related to such rights and interests.
2. Investigators must disclose any reimbursed or sponsored travel related to their institutional responsibilities with a value exceeding $5,000. Such travel includes trips paid on behalf of the Investigator rather than reimbursed directly, where the exact cost may not be known. The disclosure must cover the previous 12 months and include, at minimum, the purpose, sponsor or organizer, destination, and duration of each trip.

The disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
• 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 affiliated with a United States Institution of Higher Education
3. The term “signiﬁcant ﬁnancial interest” does not include, and therefore investigators are not required to disclose, the following types of ﬁnancial interests:
• Salary, royalties, or other remuneration paid by VitaKey to the Investigator if the Investigator is currently employed or otherwise appointed by VitaKey, including intellectual property rights assigned to VitaKey and any agreements to share royalties related to those rights.
• Any ownership interest in VitaKey held by the Investigator.
• Income from investment vehicles such as mutual funds and retirement accounts, provided the Investigator does not directly control the investment decisions for those vehicles.
• Income from seminars, lectures, or teaching engagements 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 a research institute affiliated with a U.S. institution of higher education.
• Income from service on 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 a U.S. institution of higher education.
Foreign Financial Interests: Investigators must disclose all ﬁnancial interests originating outside the United States, including income from seminars, lectures, teaching engagements, service on advisory committees or review panels, and reimbursed or sponsored travel, received from any foreign entity. This includes foreign institutions of higher education and foreign governments (including local or provincial governments). Disclosure is required when the aggregated amount of such income exceeds $5,000.

4.0 Investigator Disclosure Requirements

Investigators will disclose their SFIs that are related to the their “institutional responsibilities” and not their research responsibilities.
The Investigator SFI Disclosures will be retained by the Institution as part of the record maintenance requirements.
Investigators are required to disclose their Signiﬁcant Financial Interests (SFIs) at the following times:
1. At the time of application: The PI and all other individuals who meet the deﬁnition of “Investigator” must disclose their SFIs to the Controller with a copy to the EVP, Science and the Chief Strategy Officer. Any new Investigator who joins the project after the NIH application has been submitted or during the course of the research must also disclose their SFI(s) to the Controller with a copy to the EVP, Science and the Chief Strategy Officer promptly and before participating in the project, using the SFI Disclosure Form, CP0020-F001.
2. Annual Disclosure: Each Investigator participating in research under an NIH award must submit an updated SFI disclosure at least annually (on or before September 1) during the award period. The annual disclosure must include: (a) any new information that was not previously disclosed to VitaKey under this policy, including SFIs associated with NIH-funded projects transferred from another institution; and (b) updated details for any previously disclosed SFI, such as changes in the value of an equity interest.
3. New SFIs during the award: Each Investigator participating in PHS/NIH-funded research must submit an updated SFI disclosure within 30 days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Updated disclosure of reimbursed or sponsored travel must also be submitted within 30 days of each occurrence.

5.0 Review of SFI Disclosures

The Controller will review all SFI disclosures. Each SFI will be evaluated in relation to every PHS/NIH research application or award on which the Investigator is responsible for the design, conduct, or reporting of research, to determine whether the SFI is related to the funded research and, if so, whether it constitutes a Financial Conﬂict of Interest (FCOI).
The Institution’s review of and response to such disclosures (whether or not a disclosure resulted in the Instittution’s determination of a FCOI) will be retained as part of Instiution’s records per Sections 15 below.
The SFI disclosures will be reviewed as described below:
1. Prior to the issuance of a new award (e.g., during Just-in-Time stage): The Controller will review the Investigator’s SFIs before NIH issues a new award. If an FCOI is identiﬁed, an FCOI report will be submitted to NIH via the eRA Commons FCOI Module prior to any expenditure of funds.
2. Annual SFI disclosure: As part of the annual disclosure process, Investigators must provide updated information on any previously disclosed SFIs (e.g., revised value of an equity interest). The Controller will review these updates to determine whether changes to an existing management plan are needed. Any modiﬁcations will be reﬂected in the next Annual FCOI report submitted to NIH, if applicable.
3. Ad hoc basis during the award period: If a new Investigator joins a project or an existing Investigator acquires or discovers a new SFI during the project, the Controller will, within 60 days:
(a) review the disclosure;
(b) determine whether the SFI is related to the PHS/NIH-funded research;
(c) determine whether an FCOI exists; and, if so,
(d) implement, on at least an interim basis, a management plan.
An FCOI report will be submitted to NIH within 60 days of identifying the FCOI.

6.0 Relatedness of SFI to PHS/NIH-Funded Research and FCOI

The Controller is responsible for assessing the relatedness of SFIs to NIH-funded research and determining when they constitute a FCOI.

Relatedness Test: The Controller determines whether an Investigator’s SFI is related to research under an NIH award. An SFI is considered “related” when the Controller reasonably determines that:
• The SFI could be affected by the PHS/NIH-funded research, or
• The SFI is in an entity whose ﬁnancial interests could be affected by the PHS/NIH-funded research.
The Controller may consult with the Investigator when assessing whether an SFI is related to the research.

Designated Official FCOI Determination: An FCOI exists when the Controller reasonably determines that the SFI could directly and signiﬁcantly affect the design, conduct, or reporting of the PHS/NIH- funded research (“signiﬁcantly” meaning that the ﬁnancial interest would have a material effect on the research).

7.0 Management of Identified FCOIs

When an FCOI is identiﬁed, the Controller will determine and implement management strategies to ensure the research is conducted objectively. Examples of management strategies include:
1. Public disclosure of the FCOI (e.g., in publications or presentations, to study personnel, to the IRB, IACUC, or Data Safety Monitoring Board). While public posting of FCOIs is required only for senior/key personnel, the Controller may require disclosure of any Investigator’s FCOI as a condition of a management plan.
2. For human subjects research, disclosure of the FCOI to participants in the informed consent document
3. Appointment of an independent monitor to protect against bias in the design, conduct, and reporting of the research
4. Modiﬁcation of the research plan
5. Change of personnel roles or removal from portions of the research.
6. Reduction or elimination of the ﬁnancial interest (e.g., divesting equity)
7. Severance of relationships creating the conﬂict

The Controller will communicate the determination and the management plan in writing to the Investigator, the PI/PD, the appropriate supervisor, and the Chief Strategy Officer.
No expenditures on an NIH award may occur until the Investigator has met all disclosure requirements and agreed in writing to comply with the management plan. The Chief Strategy Officer will submit an FCOI report to NIH via the eRA Commons FCOI Module.

8.0 Monitoring Investigator Compliance

The Controller will monitor Investigator compliance with the management plan for the duration of the NIH award or until the FCOI no longer exists. Monitoring includes verifying that required public disclosures of FCOIs are made in publications, presentations, and other communications. Investigators must also disclose the FCOI in writing to study personnel and provide a copy of this disclosure to the Controller for recordkeeping.

9.0 Public Accessibility of the FCOI Policy and FCOIs Held by Senior/Key Personnel

FCOI Policy: A copy of this FCOI policy is available on VitaKey’s public website.

Identiﬁed FCOIs held by Senior/key Personnel: Before any funds are spent under an NIH award, VitaKey will ensure public accessibility by providing a written response, within ﬁve (5) business days to requests for information about any SFI that meets all three of the following criteria:

1. The SFI was disclosed, is still held by Senior/Key Personnel (the PD/PI and any other individual identiﬁed by VitaKey as senior/key personnel in the application, progress report, or other NIH submission).
2. VitaKey has determined that the SFI is related to the NIH-funded research.
3. VitaKey has determined that the SFI constitutes an FCOI.

When applicable, VitaKey will make available at least the following information:
1. Investigator’s name
2. Investigator’s title and role with respect to the research project
3. Name of the entity in which the SFI is held
4. Nature of the SFI
5. Approximate dollar value of the SFI in the following ranges: $0–$4,999; $5,000–$9,999; $10,000–$19,999; amounts between $20,000 and $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000; or a statement that the value cannot be readily determined by public prices or reasonable fair market value measures

The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of VitaKey’s identiﬁcation of a new FCOI, which should be requested subsequently by the requestor.

Information on SFIs subject to public accessibility will remain available for at least three years from the most recent update.

10.0 Reporting Identified Financial Conflicts of Interest

Prior to spending any funds under an NIH-funded award, the Chief Strategy Officer will submit an identified FCOI report to NIH, in accordance with NIH regulations, for any Investigator’s SFI determined to be an FCOI. The Controller will ensure that the Investigator has agreed to and begun implementing the associated management plan.

The Chief Strategy Officer is authorized to submit FCOI reports to NIH. FCOI reports are submitted only when an award is active and an FCOI has been identiﬁed (i.e., no award means no FCOI report, and no FCOI means no FCOI report).

Initial (Original) FCOI Reports
1. Prior to the expenditure of funds: If an FCOI is identiﬁed at the time a new NIH award is issued, the Chief Strategy Officer will submit an “Original” FCOI report through the eRA Commons FCOI Module before any funds are spent. The report must include all information required under 42 CFR 50.605(b)(3) or as outlined in NIH FAQ H.5 https://grants.nih.gov/faqs#/ﬁnancialconﬂict-of-interest.htm?anchor=52888.
2. Within 60 days during the award: If an FCOI is identiﬁed during the award period (e.g., a new SFI is disclosed or a new Investigator joins the project), the Chief Strategy Officer must submit an Original FCOI report within 60 days of identifying the FCOI.

Annual FCOI Reports: For the duration of an award, including any extensions with or without funds, VitaKey must submit an annual FCOI report to NIH. This report will indicate whether each previously reported FCOI is still being managed or no longer exists and describe any changes to the management plan, if applicable.
1. The annual report must be submitted at the same time as the Research Performance Progress Report (RPPR) or multi-year progress report, and at the time of any grant extension, following NIH guidance (see NIH FAQ H.2: https://grants.nih.gov/faqs#/financial-conflict-of- interest.htm?anchor=52885). NIH creates the opportunity for the submission of the Annual report 75 days prior to the next budget period start date for continuation awards. NIH will notify VitaKey by an email when an annual report is due.
2. Annual FCOI reports are not required at grant closeout.

Note Related to Reporting a New SFI to an Already Reported FCOI per NIH Guidance: If a new SFI is obtained for an already reported FCOI, the Institution will submit a new Original Report to include all related SFIs for the entirety into a newly submitted Original report. When the next Annual FCOI report is due on the first FCOI report that was submitted, the Institution will mark the initially reported SFI(s) as “No Longer Exist” with an explanation that the FCOI is being reported under a new Original Report and FCOI ID# due to the addition of a new SFI(s). This action will avoid duplicate reporting of the FCOI under two different FCOI ID#s for the same entity while maintaining continuity in reporting to NIH.

Revision (or Mitigation) FCOI Reports: After completing a retrospective review, VitaKey will submit a Revision report to NIH if new information about the FCOI is discovered, or a Mitigation report if the review ﬁnds that bias has occurred.

Types of FCOI Reports Summary Chart for NIH:

Required FCOI Reports to NIH via eRA Commons FCOI Module
REPORT	CONTENT	REQUIRED WHEN
New FCOI Report (Initial submission)	Grant number; PI; name of entity with FCOI; nature of FCOI; value of the ﬁnancial interest (in required increments); description of how the ﬁnancial interest relates to the research; key elements of the management plan.	Prior to the expenditure of funds on a new award or within 60 days of identifying any new FCOI during the award period.
Annual FCOI Report	Status of the FCOI (whether it is still being managed or no longer exists) and any changes to the management plan, if applicable.	Submitted annually at the same time as the annual progress report, multi-year progress report, or at the time of a grant extension.
Revised FCOI Report	If applicable, updates to a previously submitted FCOI report to describe actions that will be taken to manage the FCOI going forward or to revise the original report.	Following a retrospective review when noncompliance with the regulation is identiﬁed, if applicable.
Mitigation Report	Project number; project title; contact PI/PD; name of Investigator with FCOI; name of entity with FCOI; reason for review; detailed methodology, ﬁndings, and conclusions.	After a retrospective review when bias is found.

11.0 Training Requirements

Each Investigator will be informed of VitaKey’s FCOI Policy and trained on their responsibility to disclose foreign and domestic SFIs under this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. Training must be completed before an Investigator engages in PHS/NIH-funded research, at least once every four years, and promptly (as described below) when any of the following occur:
1. VitaKey revises this policy or related procedures in a way that affects Investigator requirements.
2. An Investigator is new to VitaKey research under an NIH award (training must be completed before participating in the research).
3. VitaKey determines that an Investigator has not complied with this policy or with a management plan issued under it (training must be completed within 30 days as directed by the Controller).

To meet the NIH training requirements of the FCOI regulation, VitaKey requires Investigators to complete the NIH FCOI tutorial from the following location, print and retain the completion certiﬁcate for audit purposes. https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html.

VitaKey also requires Investigators to review the NIH Virtual Seminar presentation on FCOI compliance from the following location: https://www.youtube.com/watch?v=D292YZ6BX24.

12.0 Noncompliance with FCOI Policy and Corrective Actions

If VitaKey identiﬁes an SFI that was not disclosed, reviewed, or managed in a timely manner, the Controller will, within 60 days: review the SFI; determine whether it is related to NIH-funded research; determine whether it constitutes an FCOI; and, if so, implement an interim management plan describing actions that have been and will be taken to manage the FCOI going forward. The Chief Strategy Officer will also submit an FCOI report to NIH via the eRA Commons FCOI Module.

In cases of noncompliance, including:
1. Failure by the Investigator to disclose an SFI that is later determined to constitute an FCOI
2. Failure by VitaKey to review or manage an FCOI
3. Failure by the Investigator to comply with an established management plan

VitaKey will, within 120 days of identifying noncompliance:
1. Conduct a retrospective review of the Investigator’s activities and the NIH-funded research to determine whether the research, or any part of it, was biased in the design, conduct, or reporting.
2. Document the retrospective review in accordance with 42 CFR 50.605(a)(3)(ii)(B) or NIH FAQ I.2 (https://grants.nih.gov/faqs#/ﬁnancial-conﬂict-of-interest.htm?anchor=52888).

If bias is found, VitaKey will promptly notify NIH and submit a mitigation report as required by 42 CFR 50.605(a)(3)(iii) or NIH FAQ I.3 (https://grants.nih.gov/faqs#/financial-conflict-of- interest.htm?anchor=52896).
The report will include:
1. The impact of the bias on the research project, and
2. The plan of action or corrective steps taken to eliminate or mitigate the effect of the bias.

VitaKey will thereafter submit FCOI reports annually to the NIH as required by the regulations and the terms and conditions of the award. Depending on the circumstances, VitaKey may implement additional interim measures regarding the Investigator’s participation in the research until the retrospective review is complete. If no bias is found, no further action is required.

13.0 Clinical Research Requirements

If HHS determines that a PHS-funded clinical research project evaluating the safety or effectiveness of a drug, medical device, or treatment was designed, conducted, or reported by an Investigator with an unmanaged or unreported FCOI, VitaKey will require the Investigator to disclose the conﬂict in every public presentation of the research results and to request an addendum to previously published presentations.

14.0 Subrecipient Requirements

A subrecipient relationship exists when federal funds ﬂow from or through VitaKey to another individual or entity that will carry out a substantive portion of a PHS-funded research project and is accountable to VitaKey for programmatic outcomes and compliance. Subrecipients (e.g. collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees) are subject to VitaKey’s terms and conditions. VitaKey will take reasonable steps to ensure that all subrecipient Investigators comply with the federal FCOI regulations at 42 CFR Part 50 Subpart F. VitaKey will include in each written agreement with a subrecipient terms specifying whether VitaKey’s FCOI Policy or the subrecipient’s own FCOI policy will apply to subrecipient Investigators (see NIH Grants Policy Statement Section 15.2.1 on Written Agreements: https://grants.nih.gov/grants/policy/nihgps/html5/section_15/15.2_administrative_and_other_requir ements.htm#Written).

· If the subrecipient’s FCOI policy applies:

The subrecipient institution must certify in the agreement that its policy complies with federal FCOI regulations. The agreement will specify the timeframe for the subrecipient to report identiﬁed FCOIs to VitaKey in time for VitaKey to meet NIH reporting deadlines (i.e., before funds are spent and within 60 days of the subrecipient identifying an FCOI).

Typically, this means requiring subrecipients to report FCOIs to VitaKey within 50–55 days of identiﬁcation. The Chief Strategy Officer will then submit the subrecipient FCOI report to NIH through the eRA Commons FCOI Module.

· If the subrecipient cannot certify compliance:

The agreement will specify that VitaKey’s FCOI Policy applies. In this case, subrecipient Investigators must disclose their SFIs to VitaKey. The SFI disclosure must include SFIs that are directly related to the subrecipient’s work for VitaKey. The agreement will allow sufficient time for VitaKey to review, manage, and report any resulting FCOIs. When an FCOI is identiﬁed, VitaKey will implement a management plan, monitor compliance by the subrecipient Investigator, and submit the required FCOI report to NIH via the eRA Commons FCOI Module.

15.0 Maintenance of Records

VitaKey will maintain records of all Investigator ﬁnancial interest disclosures, VitaKey’s review and response to those disclosures (whether or not they resulted in a determination of an FCOI), and any actions taken under this policy or through retrospective review. These records will be retained for at least three years from the date of submission of the ﬁnal expenditures report, or for longer periods such as:
1) Until all litigation, claims or audit findings, if applicable, have been resolved or
2) Until the expiry of all PHS requests for record retention extension
VitaKey will retain these records for each competitive segment as required by regulation.

16.0 Enforcement Actions for Investigator Noncompliance

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Investigators who fail to comply may be subject to disciplinary action, which can include termination of employment or contract, formal warning letter or official notice of disciplinary action, restrictions on the use of research funds, and/or disqualiﬁcation from further participation in any PHS/NIH-funded research, as deemed appropriate.

17.0 Revision History

Rev.	Effective Date	Author	Revision Comments
B	9/3/25	Andrea Stamp	Team Update
C	9/4/25	Andrea Stamp	NIH suggested revisions
D	9/5/25	Andrea Stamp	NIH suggested revisions