In compliance with 42 CFR Part 50 Subpart F and NIH Guide Notice NOT-OD-21-002, Matregenix publicly discloses its Financial Conflict of Interest (FCOI) policy applicable to all NIH-funded research (excluding Phase I SBIR/STTR). This policy is intended to promote objectivity in research by establishing standards to ensure that the design, conduct, and reporting of NIH-supported projects are free from bias.

Questions may be directed to Sherif Soliman, CEO and designated Institutional Official for FCOI compliance at: [soliman@matregenix.com]

Purpose and Scope 

Matregenix is committed to promoting objectivity in research by complying with the Public Health Service (PHS) regulations on financial conflicts of interest (FCOI), specifically the NIH requirements at 42 CFR Part 50, Subpart F (Promoting Objectivity in Research) and NIH guidance. This policy applies to all research projects at Matregenix that are funded by the National Institutes of Health (NIH) or other PHS agencies. (Note: The NIH FCOI regulation covers all NIH grants and cooperative agreements, including Phase II SBIR/STTR awards, while Phase I SBIR/STTR awards are exempt. Matregenix will adhere to this policy for all applicable awards.) Although Matregenix currently has no external private investors and actual financial conflicts are unlikely, this policy provides a comprehensive framework to identify and manage any potential conflicts, thereby safeguarding the integrity of our NIH-funded research.

Definitions

• Investigator – The project director or principal investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (including NIH), or proposed for such funding. This definition may include collaborators or consultants as appropriate.
• Institutional Responsibilities – An Investigator’s professional responsibilities on behalf of Matregenix. These can include activities such as research, research consultation, teaching, professional practice, institutional committee service, and service on review panels (e.g. IRBs or Data Safety Monitoring Boards)
• Senior/Key Personnel – The PD/PI and any other individuals identified as senior or key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS.
• Significant Financial Interest (SFI) – A financial interest of the Investigator (and their spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities, and that meets one or more of the following criteria:
  
  • Equity/Remuneration in a Public Company: Remuneration plus equity interest in any publicly traded entity exceeds $5,000 in aggregate over the preceding 12 months.
    
  • Equity/Remuneration in a Private Company: Any remuneration received from a nonpublicly traded entity in the past 12 months that exceeds $5,000, or any equity interest in such an entity.
  • Intellectual Property (IP) Rights and Interests: Rights in intellectual property (e.g. patents, copyrights) upon receipt of income related to such rights and interests.
  • Reimbursed or Sponsored Travel: Any reimbursed or sponsored travel related to the Investigator’s institutional duties, except if the travel is sponsored by a U.S. government agency or U.S. academic institution.

Certain financial interests are excluded from the definition of SFI, such as salary or royalties from Matregenix, ownership interests in Matregenix, or income from mutual funds not controlled directly by the Investigator.

• Financial Conflict of Interest (FCOI) – A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
• Institutional Official (FCOI Officer) – The official designated by Matregenix to solicit disclosures of SFIs from Investigators, review those disclosures, and determine whether an SFI is related to PHS-funded research and if it constitutes an FCOI. Matregenix designates Sherif Soliman, CEO, as the Institutional Official responsible for FCOI oversight and decisions.
  
  

Investigator Disclosure of Significant Financial Interests 

Disclosure Requirement: All Investigators participating in NIH-funded research at Matregenix are required to disclose any Significant Financial Interests (SFIs) (including those of their spouse and dependent children) that are related to their institutional responsibilities. This includes SFIs held or received from foreign entities as well as domestic ones.

Timing of Disclosures: 

• Initial Disclosure: No later than the time of application for NIH-funded research.
• Annual Updates: At least annually during the period of the award.
  
• New Acquisitions: Within 30 days of discovering or acquiring a new SFI.

All disclosures should be made in writing using Matregenix’s Significant Financial Interest Disclosure Form. 

Foreign Financial Interests: Investigators must disclose all financial interests from foreign entities.Income or travel reimbursement from foreign universities or governments must be disclosed if it meets the SFI threshold.
Subrecipient Investigators: If Matregenix is the prime awardee and engages subrecipients, subrecipient Investigators must also disclose SFIs to either their own institution or Matregenix, depending on the agreement.

Investigator Training Requirements

All Investigators must complete FCOI training: 

• Before engaging in NIH-funded research.
• At least every four years.
• Immediately if policy is revised, new to the institution, or noncompliant

Training includes NIH online resources and in-house materials. Completion will be documented.

Review of Disclosures and FCOI Determination

Designation of Official: Sherif Soliman, CEO, serves as the Institutional Official to review SFI disclosures.
Determination of Relatedness and FCOI: The official will assess whether an SFI is related to NIHfunded research and whether it constitutes an FCOI.

Timing of Review: 

• Prior to expenditure of funds.
  
• Within 60 days of new disclosures.
  
• Ad hoc as needed.
  

Management of Financial Conflicts of Interest

When an FCOI is identified, Matregenix will develop a written Management Plan including: 

• Public disclosure.
• Disclosure to research participants.
• Appointment of an independent monitor.
• Modification of the research plan.
• Change of personnel or responsibilities.
• Elimination of the financial interest.
• Severance of relationships.

Plans must be acknowledged by the Investigator. Compliance will be monitored.

NIH Reporting of FCOIs 

FCOIs will be reported via the eRA Commons FCOI Module: 

• Initial Report: Prior to expenditure of funds.
  
• Update Report: Within 60 days of discovering new FCOIs.
  
• Annual Report: At the time of the progress report.
  

Reports will include project information, Investigator and entity name, nature and value of SFI, relation to NIH research, and management plan summary.

Public Accessibility 

• The FCOI policy is posted on Matregenix’s website.
  
• Information concerning FCOIs held by senior/key personnel will be made available by written
  request within 5 business days.
  
• Information is updated annually and within 60 days of any new FCOI.
  
• Records are retained for at least three years from the most recent update.
  

Record Retention 

All records of SFI disclosures, reviews, determinations, and management plans are retained for at least three years from the date of the final expenditure report or longer if required

Noncompliance, Retrospective Review, and Mitigation  

• Retrospective review must occur within 120 days of discovering noncompliance.
  
• If bias is found, a mitigation report will be submitted to NIH.
  
• In clinical research, the Investigator must disclose unreported FCOIs in all public presentations and request an addendum to published materials
  

Subrecipient Compliance  

• Subrecipients must comply with FCOI regulations:
  
• Subrecipients may follow their own FCOI policy if NIH-compliant or Matregenix’s policy.
  
• Subrecipient agreements will include certification, disclosure obligations, and reporting timelines.
  
• Matregenix is responsible for reporting subrecipient FCOIs to NIH.

Approval and Revision History: Approved by Sherif Soliman, CEO. This policy is reviewed periodically and updated as needed to comply with NIH regulations. The current version is posted on the Matregenix website.