Financial Conflict of Interest (FCOI) Policy

I. PURPOSE

The purpose of this policy is to establish guidelines within ClinArk Inc. to prevent bias in Public Health Service (PHS)-funded research due to financial conflict of interest (FCOI). This policy complies with the relevant regulations (42 CFR Part 50 Subpart F) to ensure the integrity of our research.

II. TRAINING REQUIREMENTS (42 CFR 50.604(b))

Every ClinArk Inc. investigator involved in PHS-funded research must complete FCOI training:

• Prior to engaging in research related to any PHS-funded grant.

• At least once every four years.

• Immediately when:

  • ClinArk Inc. revises its FCOI policy in a way that affects the Investigator's requirements.

  • An Investigator is new to ClinArk Inc.

  • An Investigator is found non-compliant with the FCOI policy or management plan.

III. DISCLOSURE, REVIEW, AND MONITORING REQUIREMENTS

ClinArk Inc. investigators must disclose their Significant Financial Interests (SFIs) and those of their spouse and dependent children as outlined in 42 CFR 50.603 and 50.604(e)(1)-(3). The disclosure must occur:

• No later than at the time of application for PHS-funded research.

• At least annually during the period of the award.

• Within 30 days of discovering or acquiring a new SFI.

• ClinArk Inc. will designate an official(s) to review all SFIs, determine if any SFI is related to PHS-funded research, and if so, whether it is an FCOI (42 CFR 50.604(d), 50.604(f)). The designated official(s) will review all SFI disclosures prior to the institution's expenditure of funds (42 CFR 50.605(a)(1)).

IV. REPORTING REQUIREMENTS TO NIH (42 CFR 50.604(h), 50.605(b))

ClinArk Inc. will send FCOI reports to the NIH:

• Prior to the expenditure of funds.

• Within 60 days of identifying an FCOI for an Investigator who is newly participating in the project.

• At least annually, to provide the status of the FCOI and any changes to the management plan.

• Following a retrospective review, update a previously submitted report, if appropriate.

• If an Investigator fails to comply with ClinArk Inc.'s FCOI policy, or if a FCOI management plan appears to have biased the design, conduct, or reporting of NIH-funded research, ClinArk Inc. will notify NIH promptly (42 CFR 50.606(a)).

V. MAINTENANCE OF RECORDS (42 CFR 50.604(i))

All FCOI-related records will be maintained by ClinArk Inc. for at least three years from the date the final expenditures report is submitted to the NIH, or from other dates specified in 45 CFR 75.361, where applicable.

VI. ENFORCEMENT MECHANISMS AND REMEDIES (42 CFR 50.604(j), 50.605(a)(3), 50.606(c))

ClinArk Inc. will enforce this policy through mechanisms such as employee sanctions or other administrative actions. In case of non-compliance, ClinArk Inc. will complete and document retrospective reviews within 120 days and establish procedures to manage non-compliance.

VII. SUBRECIPIENT REQUIREMENTS (42 CFR 50.604(c))

If applicable, ClinArk Inc. will establish written agreements with sub-recipients regarding FCOI policies and procedures, following the requirements outlined in 42 CFR 50.604(c)(1)(i)-(iii).

VIII. PUBLIC ACCESSIBILITY REQUIREMENTS (42 CFR 50.604(a), 50.605(a)(5)(i)-(iv))

ClinArk Inc.'s FCOI policy will be publicly accessible through ClinArk Inc.'s website. Identified FCOIs held by senior/key personnel will also be made available prior to the expenditure of funds.

IX. POLICY REVIEW

This policy will be reviewed at least once every four years or whenever necessary to ensure it remains updated, compliant, and relevant within ClinArk Inc.

This policy is effective as of June 10, 2023.