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

For the purpose of these policies and procedures, the following definitions apply:

• Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly a=ect the design, conduct, or reporting of PHS-funded research.
• Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.
• Institutional Responsibilities: Professional activities an Investigator performs on behalf of Matregenix (e.g., research, development, publication, consulting, administration, public relations, committee memberships, or any other duties defined by their role at the company).
• Designated Official (DO): The individual(s) designated by Matregenix as an O=icer to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests, identification of FCOIs per the regulatory criteria provided in 42 CFR 50.604(f), and monitoring sta= FCOI training requirements. Dr. Sherif Soliman is the designated o=icial in charge.
• Investigator: The Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by an award or proposed for funding, which may include collaborators or consultants. Matregenix will consider the individual’s role, rather than the title, and the degree of independence with which the individual works when determining who is responsible for the design, conduct, or reporting of
  the PHS-funded research.
• Research: A systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or therapeutic drug).
• PHS-Funded Research: Any activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized 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 of the PHS.
• Senior/Key Personnel: The PD/PI and any other person identified as senior/key personnel by Matregenix in the grant application, progress report, or any other report submitted to the PHS/NIH by Matregenix. This term is defined only as it relates to the public accessibility requirements described under Section 8.

• Significant Financial Interest (SFI):

  • A domestic or foreign 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 appear to be related to the Investigator’s institutional responsibilities performed on behalf of Matregenix:
    • 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. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
    • 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).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).
    • Intellectual Property Rights and Interests: A significant financial interest exists upon receipt of income greater than $5,000 related to such rights and interests (e.g., patents, copyrights).
  • Investigators must disclose the occurrence of any reimbursed or sponsored travel that exceeds $5,000 (i.e., paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be
    readily available) related to the Investigator’s institutional responsibilities. The initial disclosure of reimbursed or sponsored travel should include income received over the previous twelve months. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The disclosure requirement does not apply to travel reimbursed or 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 affiliated with a United States Institution of Higher
      Education.
  • 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 Matregenix to the Investigator if the Investigator is currently employed or otherwise appointed by Matregenix, including intellectual property rights assigned to Matregenix and agreements to share in royalties related to such rights.
    • Any ownership interest in Matregenix held by the Investigator, as Matregenix is a commercial or for-profit organization and such interest is excluded from the SFI definition per regulation.
    • 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.
    • Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States, 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 federal, state, or local government agency located in the United States, a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute a=iliated with a U.S. Institution of higher education.
  • Foreign Financial Interests: Investigators must disclose all foreign financial interests (including income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or a foreign government (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000)
    

Significant Financial Interest Disclosure Requirements

• At the time of application: The Principal Investigator and all other individuals who meet the definition of ‘Investigator’ must disclose their SFIs to Matregenix’s Designated Official(s). Any new Investigator who, after applying for NIH funding or during the course of the research project, plans to participate in the project must similarly disclose their SFI(s) to the Designated Official(s) promptly and prior to participation in the project.
• Annually: Each Investigator participating in research under an NIH award must submit an updated disclosure of SFI at least annually (on or before June 19), during the period of the award. Such disclosure must include any information not
  disclosed initially to Matregenix pursuant to this Policy or in a subsequent disclosure of SFI (e.g., any financial conflict of interest identified on an NIH-funded project directly as an NIH Grantee and/or indirectly through a sub-award) that was transferred from another Institution, and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest).

• Any New SFI: Each Investigator participating in PHS/NIH-funded research must submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Investigators must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

Review of SFI Disclosures by Matregenix Designated Official(s)

The Designated Offical(s) will conduct reviews of SFI disclosures. The Designated Offical(s)will review any SFI identified in a disclosure and compare these interests to each PHS/NIH research application and/or award on which the Investigator is identified as  responsible for the design, conduct, or reporting of the research to determine if the SFI is related to the PHS/NIH-funded research and, if so, whether the SFI creates a Financial Conflict of Interest (FCOI) related to that research award as explained in Section 5.

• Prior to Award: The Designated Offical(s) will review the Investigator’s SFI(s) prior to the NIH issuing a new award. If an FCOI is identified, Matregenix will submit an FCOI report to the NIH via the eRA Commons FCOI Module prior to the expenditure of funds under the new award.
• Annual Disclosure: The annual disclosure will require the Investigator to disclose updated values of any previously disclosed SFIs (e.g., the updated value of a previously disclosed equity interest). The Designated Offical(s) will review the Investigator’s annual disclosure and use the updated information to determine if any changes are needed to an existing management plan. Any changes to an existing management plan will be reported to the NIH when the next Annual FCOI report is due, if applicable.
• During Award Period: Whenever, in the course of an ongoing NIH-funded research project, an Investigator who is new to participating in the research project discloses a SFI or an existing Investigator discloses a new SFI, the Designated O=icial(s) will,within 60 days: review the disclosure of SFI, determine whether the SFI is related to the NIH-funded research, determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage the FCOI. Matregenix will submit the FCOI report to the NIH within 60 days of identifying the FCOI.
  

Guidelines for Determining ‘Relatedness’ of SFI to PHS/NIH-Funded Research and a Financial Conflict of Interest

The Designated Official(s) will determine whether an Investigator’s SFI is related to the research under an NIH award and, if so, whether the SFI is a financial conflict of interest.

• Relatedness Test: An Investigator’s SFI is related to the research when the Designated Official(s) reasonably determines the SFI
  • Could be affected by the PHS/NIH-funded research; or

  • Is in an entity whose financial interest could be affected by the PHS/NIH-funded research

• FCOI Determination: A financial conflict of interest exists when the Designated Official(s) reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. ‘Significantly’ means that the financial interest would have a material effect on the research.
  

The Designated Official(s) may involve the Investigator in determining whether a significant financial interest is related to the PHS-funded research.

Management of Significant Financial Interests that Pose Financial Conflict of Interest

If a financial conflict of interest exists, the Designated Official(s) will determine what management conditions and/or strategies will be put in place to manage the FCOI.Examples of conditions that might be imposed to manage a financial conflict of interest include, but are not limited to: 

• Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel working on the study, to the Institution’s Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.);
• For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants in the informed consent document;

• Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;

• 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);
• Severance of relationships that create financial conflicts.
  
  

f the Designated Official(s) determines that a conflict exists, it will communicate its determination and the means developed for managing the FCOI in writing to the individual,the relevant Principal Investigator/Project Director, and the appropriate direct supervisor. No expenditures on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the Designated Official(s) necessary to manage the Financial Conflict of Interest. The FCOI Designated Official(s) of Matregenix will submit the FCOI report to NIH via the eRA Commons FCOI Module

Monitoring Investigator Compliance

Matregenix will monitor Investigator compliance with the management plan for the duration of the NIH award or until the FCOI no longer exists. Monitoring of public disclosure requirements will include reviewing publications and presentations to confirm that the Investigator disclosed the FCOI in such communications. To facilitate additional monitoring, Investigators will be required to disclose the FCOI in writing to research personnel in the study and send a copy of the communication to the Designated Official(s).

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under an NIH award, Matregenix will ensure public accessibility by posting the FCOI policy on its publicly accessible website (www.matregenix.com/fcoi-policy) (www.matregenix.com/fcoi-policy) and by providing written response to any requestor within five business days of a request for information concerning any SFI disclosed that meets the following three criteria:

• The SFI was disclosed and is still held by the senior/key personnel (PD/PI and any other person identified as senior/key personnel by Matregenix in the award application, progress report, or any other report submitted to the NIH);

• Matregenix has determined that the SFI is related to the research funded through an award; and

• Matregenix has determined that the SFI is a financial conflict of interest
  

The information made available via the public website or in a written response will include,at a minimum:

• The Investigator’s name;
• The Investigator’s title and role with respect to the research project;
• The name of the entity in which the Significant Financial Interest is held;
• The nature of the Significant Financial Interest; and
• The approximate dollar value of the Significant Financial Interest in the following

ranges: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000- $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

The information posted on the public website will be updated at least annually and within sixty days of receipt or identification of information concerning any additional Significant Financial Interest of the senior/key personnel for the NIH-funded research project that had not been previously disclosed, or upon the disclosure of a Significant Financial Interest of senior/key personnel new to the NIH-funded research project, if it is determined by the Designated Official(s) that the Significant Financial Interest is related to the research and is a financial conflict of interest. Information concerning an individual’s SFI will remain available for at least three years from the date that the information was most recently updated.

Reporting of Financial Conflicts of Interest

Matregenix will assign an institutional o=icial to serve as the FCOI Signing O=icial (SO) within the eRA Commons FCOI Module. The FCOI SO has the authority to submit FCO reports to the NIH. FCOI reports are submitted to the NIH only when a grant or cooperative agreement is active and an FCOI is identified (i.e., no award – no FCOI and no FCOI – no FCOI report). The FCOI Module User Guide is available at

https://www.era.nih.gov/files/fcoi_user_guide.pdf to assist in submitting reports to the

NIH.

INITIAL OR ORIGINAL (Original) FCOI REPORTS:

• Prior to the Expenditure of Funds: When an FCOI is identified upon the issuance of a new NIH award, the FCOI SO will submit a NIH “2011 FCOI” Original report prior to the expenditure of any funds under an NIH award. The Original FCOI report will include the information required in the regulation at 42 CFR Part 50.605(b)(3) or as outlined in NIH's FAQ H.5. at https://grants.nih.gov/faqs#/financial-conflict-ofinterest.htm?anchor=52888.
• Within 60 days of Identifying a new FCOI During Award Period: When an FCOI isidentified during the period of an NIH-funded award (e.g., a new SFI is identified foran Investigator, or upon the participation of a new Investigator), Matregenix willprovide to NIH within 60 days of identifying the FCOI, an Original FCOI report regarding the financial conflict of interest.

ANNUAL FCOI REPORTS: While the award is ongoing (including any extensions with or without funds), Matregenix will provide NIH with an annual FCOI report that addresses the status of the previously reported FCOI (i.e., whether the FCOI is still being managed or if it no longer exists) and any changes in the management plan, if applicable. The Annual FCOI report will be submitted at the same time as when the Research Performance Progress Report or multi-year progress report is due and at the time of grant extension, if applicable, per the NIH guidance (see NIH’s FAQ H.2. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52860). The NIH will send an annual report email notification to the Institution when an annual report is due.

Annual FCOI reports are not submitted as part of grant closeout.

REVISION (or Mitigation) FCOI REPORTS: Following the completion of a retrospective review, the Institution will provide NIH with a Revision if new information is discovered or a Mitigation Report if bias is found.

The types of FCOI reports and their requirements are summarized below:

Training Requirements

Each Investigator will be informed about Matregenix’s Financial Conflict of Interest Policy and trained on the Investigator’s responsibility to disclose foreign and domestic SFIs per this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur prior to an Investigator engaging in PHS/NIH-funded research, at least every four years, and Immediately (as defined below) when any of the following circumstances apply:

• Matregenix revises this Policy, or procedures related to this Policy, in any manner
• that affects the requirements of Investigators;
• An Investigator is new to Matregenix research under an NIH award (training is to be completed prior to his/her participation in the research); or
• Matregenix finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the Designated Official(s)).

To fulfill the FCOI training requirement, Matregenix requires its Investigators to complete the National Institutes of Health’s Financial Conflict of Interest tutorial located at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html in accordance with the requirements and expectations of this Policy. All Investigators must print a certification of completion at the end of training and retain it for audit purposes. Additionally, Matregenix requires its Investigators to review the NIH Virtual Seminar presentation on developing or refining institutional FCOI policies at https://www.youtube.com/watch?v=D292Y26BX24

Failure to Comply with Matregenix Financial Conflict of Interest Policy Applicable to Public Health Service Funded Award

Whenever the Institution identifies an SFI that was not disclosed, identified, reviewed or managed in a timely manner, the designated o=icial(s) will within 60 days: review the SFI, determine whether the SFI is related to research; determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward. The Institution will also submit an FCOI report to the PHS/NIH via the eRA Commons FCOI Module. In addition, whenever an FCOI is not identified or managed in a timely manner, including:

• Failure by the Investigator to disclose a significant financial interest that is determined by Matregenix to constitute a FCOI;
• Failure by Matregenix to review or manage such an FCOI;
• Failure by the Investigator to comply with a management plan;

Matregenix will, within 120 days of determining non-compliance:

• Complete a retrospective review of the Investigator’s activities and the PHS/NIH-funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research;
• Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B) or as described in NIH’s FAQ I.2. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52895

If bias is found, Matregenix shall notify NIH promptly and submit a mitigation report per the regulation at 42 CFR 50.605(a)(3)(iii) or as described in NIH’s FAQ I.3. at https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=52896 to NIH via the eRA Commons FCOI Module that shall address:

• Impact of the bias on the research project, and
• Matregenix’s plan of action or actions taken to eliminate or mitigate the eFFect of the bias.

Thereafter, Matregenix will submit FCOI reports annually to NIH in accordance with the NIH guidance as provided in the summary chart above. Depending on the nature of the Financial Conflict of Interest, Matregenix may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the Financial Conflict of Interest is identified and the completion of Matregenix’s independent retrospective review.

If bias is not found, no further action will be taken unless new information is discovered that needs to be reported to the NIH. If applicable, update existing FCOI report to specify the actions that have been, and will be, taken to manage the FCOI going forward or update previously submitted report information (e.g., increase in value of the SFI or add any newly identified SFIs) following the completion of the retrospective review

Clinical Research Requirements

If the Department of Health and Human Services determines that one of its funded clinical research projects, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a Financial Conflict of Interest that was not managed or reported by Matregenix, Matregenix shall require the Investigator involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Subrecipient Requirements

subrecipient relationship is established when federal funds flow down from or through Matregenix to another individual or entity, and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to Matregenix for programmatic outcomes and compliance matters. Subrecipients, including but not limited to collaborators, consortium members, consultants, contractors, subcontractors, and sub-awardees, are subject to Matregenix’s terms and conditions. Matregenix will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation at 42 CFR Part 50 Subpart F.

Matregenix will incorporate, as part of a written agreement with the subrecipient, terms that establish whether Matregenix’s FCOI Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator(s). See the NIH Grants Policy Statement Section 15.2.1 Written Agreement at https://grants.nih.gov/grants/policy/nihgps/html5/section_15/15.2_administrative_and_oth er_requirements.htm.

• If the subrecipient’s FCOI policy applies: The subrecipient institution will certify as part of the agreement with Matregenix that its policy is in compliance with the federal FCOI regulation. The agreement shall specify the time period for the subrecipient to report all identified FCOIs to Matregenix (e.g., within 55 days of identification to allow Matregenix to report within 60 days) to enable Matregenix to provide timely FCOI reports to the PHS/NIH as required by the regulation. The Matregenix assigned FCOI SO will submit the FCOI report (subrecipient report) to the NIH via the eRA Commons FCOI Module.
• If the subrecipient cannot provide certification: The agreement shall state that the subrecipient Investigator is subject to Matregenix’s FCOI Policy for disclosing SFI(s)that are directly related to the subrecipient’s work for Matregenix. Matregenix will require the submission of all Investigator disclosures of SFIs to Matregenix. The agreement will include sufficient time period(s) to enable Matregenix to comply timely with its review, management, and reporting obligations under the regulation. When an FCOI is identified, Matregenix will develop a management plan, monitor subrecipient Investigator compliance with the plan, and submit an FCOI report(subrecipient report) to the NIH through the eRA Commons FCOI Module

Maintenance of Records

Matregenix will keep all records of all Investigator disclosures of financial interests and Matregenix’s review of, or response to, such disclosures (whether or not a disclosure resulted in the determination of a Financial Conflict of Interest), and all actions under this policy or retrospective review, if applicable. Records of financial disclosures and any resulting action will be maintained for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 75.361 for di=erent situations. Matregenix will retain records for each competitive segment as provided in the regulation.

Enforcement Actions When an Investigator Fails to Comply with This Policy

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators. Investigators who fail to comply with this policy are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment, or disqualification from further participation in any PHS/NIH-funded research, as deemed appropriate

Useful FCOI and NIH Resources

• FCOI Regulation 42 CFR Part 50 Subpart F: https://www.ecfr.gov/current/title- 42/chapter-I/subchapter-D/part-50/subpart-F
• Financial Conflict of Interest: https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi
• FCOI Training: https://grants.nih.gov/policy-and-compliance/policy-topics/fcoi/fcoi-training
• FCOI Frequently Asked Questions (FAQs): https://grants.nih.gov/faqs#/financial-conflict-of-interest.htm?anchor=3875
• Information for Foreign Grants: https://grants.nih.gov/new-to-nih/information-for/foreign-grants
• NIH’s Welcome Wagon Letter: https://grants.nih.gov/policy-and-compliance/welcome-wagon
•  NIH Grants Policy Statement: https://grants.nih.gov/policy/nihgps/index.htm
• NIH Guide for Grants and Contracts: https://grants.nih.gov/funding/guide.html
• NIH Extramural Nexus:https://public.govdelivery.com/accounts/USNIHOER/subscriber/new?qsp=CODE_RED
  
  

Point of Contact

For questions related to Matregenix’s Financial Conflict of Interest Policy or to disclose an SFI or potential FCOI, contact: soliman@matregenix.com