Financial Conflict of Interest Policy

Effective September 23, 2026

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Bold Type LLC maintains this Financial Conflict of Interest (FCOI) policy in accordance with 42 CFR Part 50, Subpart F, which applies to research funded by the U.S. Public Health Service, including the National Institutes of Health. The signed policy is available as a PDF.

Download the signed policy (PDF)

Policy Owner: President and CEO
Effective Date: September 23, 2026
Regulatory Basis: 42 CFR Part 50, Subpart F, "Promoting Objectivity in Research"; NIH Grants Policy Statement Section 4.1.10

1. Purpose and Scope

Bold Type LLC (“Bold Type” or the “Company”) is committed to ensuring that the design, conduct, and reporting of research funded by the U.S. Public Health Service (PHS), including the National Institutes of Health (NIH), is free from bias resulting from Investigator financial conflicts of interest.

This policy applies to every Investigator who plans to participate in, or is participating in, PHS-funded research for which Bold Type is the applicant or recipient, including SBIR and STTR Phase II awards and any other PHS grant or cooperative agreement. The FCOI Regulation does not apply to SBIR/STTR Phase I awards; however, Bold Type applies this policy to all PHS-funded research as a matter of practice.

This policy applies to subrecipient Investigators as described in Section 10.

2. Definitions

Investigator means 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 PHS-funded research, including persons who are subrecipients, consultants, or collaborators.

Institutional Responsibilities means an Investigator’s professional responsibilities on behalf of Bold Type, including research, product development, consulting, and service on committees or boards.

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

Significant Financial Interest (SFI) means 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 Responsibilities:

  1. With regard to any publicly traded entity, an SFI 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 (for example, 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.

  2. With regard to any non-publicly traded entity, an SFI 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 (for example, stock, stock option, or other ownership interest).

  3. Intellectual property rights and interests (for example, patents, copyrights) upon receipt of income related to such rights and interests.

  4. Reimbursed or sponsored travel (that is, travel 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. This disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

The term SFI does not include: salary, royalties, or other remuneration paid by Bold Type to the Investigator if the Investigator is currently employed or otherwise appointed by Bold Type, including intellectual property rights assigned to Bold Type and agreements to share in royalties related to such rights; 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, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or income from service on advisory committees or review panels for such entities.

Financial Conflict of Interest (FCOI) means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Designated Official means the individual designated by Bold Type to solicit and review SFI disclosures and to make FCOI determinations, as described in Section 4.

PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated, including NIH.

Senior/Key Personnel means the PD/PI and any other person identified as senior/key personnel by Bold Type in the grant application, progress report, or any other report submitted to the PHS.

3. Training

Each Investigator must complete FCOI training before engaging in research related to any PHS-funded grant, and at least every four years thereafter. Training must also be completed immediately when:

  • Bold Type revises this policy in a manner that affects Investigator requirements;
  • an Investigator is new to Bold Type; or
  • Bold Type finds that an Investigator is not in compliance with this policy or with an FCOI management plan.

Bold Type will inform each Investigator of this policy, the Investigator’s disclosure responsibilities, and the FCOI Regulation. Training is satisfied by completion of the NIH FCOI tutorial or an equivalent course (for example, the CITI “Conflicts of Interest” course). The Designated Official maintains a record of each Investigator’s training completion date.

4. Designated Official

The President and CEO of Bold Type serves as the Designated Official. The Designated Official solicits and reviews SFI disclosures, determines whether an SFI relates to PHS-funded research and whether an FCOI exists, develops and monitors management plans, and submits FCOI reports to NIH.

When the Designated Official is also an Investigator on the PHS-funded research being reviewed, or otherwise has a personal interest in the outcome, the Designated Official’s own disclosure will be reviewed by an alternate reviewer who is not an Investigator on that project. The alternate reviewer is the Company’s outside legal counsel or an independent member of Bold Type’s management designated in writing by the Company. The alternate reviewer applies the same standards described in this policy.

5. Disclosure of Significant Financial Interests

Each Investigator must disclose to the Designated Official all SFIs (including those of the Investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities:

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

  2. At least annually during the period of the award, with the annual disclosure updated to include any information not previously disclosed and any updated information regarding previously disclosed SFIs (for example, the updated value of an equity interest); and

  3. Within 30 days of discovering or acquiring a new SFI (for example, through purchase, marriage, or inheritance).

Disclosures are made on the Bold Type Significant Financial Interest Disclosure Form and are retained by the Designated Official. For reimbursed or sponsored travel, the disclosure must include at least the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration. The Designated Official will determine whether further information is needed, including a determination or disclosure of the monetary value, to decide whether the travel constitutes an FCOI.

6. Review of Disclosures and Determination of FCOI

Before Bold Type expends any funds under a PHS-funded research project, the Designated Official will:

  1. review all Investigator SFI disclosures;

  2. determine whether any SFI is related to the PHS-funded research, meaning that the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research;

  3. determine whether any related SFI is an FCOI, meaning that the SFI could directly and significantly affect the design, conduct, or reporting of the research; and

  4. where an FCOI exists, develop and implement a management plan that specifies the actions that have been, and will be, taken to manage the FCOI.

The Designated Official will also complete steps (a) through (d) within 60 days whenever an Investigator who is new to participating in the research project discloses an SFI, or whenever an existing Investigator discloses a new SFI.

Examples of conditions or restrictions that may be imposed to manage an FCOI include: public disclosure of the FCOI (for example, when presenting or publishing the research); disclosure of the FCOI directly to research participants, for research involving human subjects; appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; 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 (for example, sale of an equity interest); or severance of relationships that create the FCOI.

Bold Type’s ownership structure is disclosed and reviewed under this policy. Where an Investigator holds an equity interest in Bold Type itself, or in an affiliated entity that holds rights to technology being developed under a PHS-funded project, the Designated Official (or alternate reviewer under Section 4) will evaluate whether that interest constitutes an FCOI and, if so, will implement a management plan. In the case of clinical research evaluating the safety or effectiveness of a device developed by the Company, management plans will typically include disclosure of the interest to the IRB of record and in the informed consent, disclosure in publications and presentations, and use of independent clinical sites and investigators for enrollment, data collection, and outcome assessment.

7. Monitoring

The Designated Official monitors Investigator compliance with each management plan on an ongoing basis until the completion of the PHS-funded research project. Monitoring may include periodic written confirmation from the Investigator, review of study documents and publications, and consultation with independent monitors where appointed.

8. Reporting to NIH

Bold Type will submit FCOI reports to NIH through the eRA Commons FCOI Module as follows:

  1. Initial report. Before expenditure of any funds under a PHS-funded research project, Bold Type will report any Investigator FCOI and ensure that a management plan has been implemented.

  2. New Investigators or new SFIs. Within 60 days of identifying an FCOI for an Investigator who is newly participating in the project, or for a newly identified FCOI of an existing Investigator, Bold Type will submit an FCOI report and ensure that a management plan has been implemented. Where an FCOI is identified after expenditure of funds, Bold Type will also conduct the retrospective review described in Section 9.

  3. Annual report. For any FCOI previously reported, Bold Type will submit an annual FCOI report at the same time it submits the annual progress report (RPPR), multi-year progress report, or request for an extension. The annual report will specify whether the FCOI is still being managed or explain why it no longer exists.

  4. Revised reports. Bold Type will update a previously submitted FCOI report following a retrospective review, where appropriate.

Each FCOI report will include, at minimum: the project number; the PD/PI or contact PD/PI; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has the FCOI; the nature of the financial interest (for example, equity, consulting fee, travel reimbursement, honorarium); the value of the financial interest, in the ranges specified by the FCOI Regulation, or a statement that the interest is one whose value cannot be readily determined; a description of how the financial interest relates to the PHS-funded research and the basis for the determination that the financial interest conflicts with the research; and a description of the key elements of the management plan, including the role and principal duties of the conflicted Investigator in the research project, the conditions of the management plan, how the management plan is designed to safeguard objectivity in the research project, confirmation of the Investigator’s agreement to the management plan, how the management plan will be monitored to ensure Investigator compliance, and other information as needed.

9. Noncompliance, Retrospective Review, and Mitigation Reports

Whenever an SFI is not disclosed timely by an Investigator, or is not reviewed timely by Bold Type, or whenever an FCOI is not identified or managed in a timely manner (including failure by the Investigator to disclose an SFI that is determined to be an FCOI, failure by Bold Type to review or manage such an FCOI, or failure by the Investigator to comply with a management plan), the Designated Official will:

  1. within 60 days, review the SFI, determine whether it is related to the PHS-funded research, determine whether an FCOI exists, and, if so, implement a management plan on at least an interim basis; and

  2. within 120 days of the determination of noncompliance, complete and document a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the period of noncompliance was biased in the design, conduct, or reporting of such research.

The retrospective review will be documented and will include, at minimum: the project number; the project title; the PD/PI or contact PD/PI; the name of the Investigator with the FCOI; the name of the entity with which the Investigator has the FCOI; the reason(s) for the retrospective review; a detailed methodology used for the review (for example, the methodology of the review process, composition of the review panel, documents reviewed); findings of the review; and conclusions of the review.

If bias is found, Bold Type will promptly notify NIH and submit a Mitigation Report. The Mitigation Report will include, at minimum, the key elements documented in the retrospective review, a description of the impact of the bias on the research project, and Bold Type’s plan of action to eliminate or mitigate the effect of the bias (for example, impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, Bold Type will submit FCOI reports annually in accordance with Section 8.

Bold Type will also promptly notify NIH whenever an Investigator fails to comply with this policy or with an FCOI management plan and that failure appears to have biased the design, conduct, or reporting of the PHS-funded research, and will take corrective action.

10. Subrecipients

When Bold Type carries out PHS-funded research through a subrecipient (for example, a subaward to a university), Bold Type will take reasonable steps to ensure that each subrecipient Investigator complies with the FCOI Regulation by incorporating into the written subaward agreement terms that establish whether the FCOI policy of Bold Type or that of the subrecipient will apply to the subrecipient’s Investigators.

  1. If the subrecipient’s Investigators will comply with the subrecipient’s FCOI policy, the subrecipient must certify as part of the agreement that its policy complies with the FCOI Regulation. If the subrecipient cannot provide such certification, the agreement will state that subrecipient Investigators are subject to this policy for disclosing SFIs that are directly related to the subrecipient’s work for Bold Type. The agreement will also specify time periods for the subrecipient to report all identified FCOIs to Bold Type sufficient to enable Bold Type to provide timely FCOI reports to NIH.

  2. If the subrecipient’s Investigators will comply with this policy, the agreement will specify time periods for the subrecipient to submit all Investigator SFI disclosures to Bold Type sufficient to enable Bold Type to review, manage, and report identified FCOIs to NIH within the required time frames.

Bold Type will report identified FCOIs of subrecipient Investigators to NIH in the same manner and time frames as for its own Investigators.

11. Public Accessibility

This policy is posted on Bold Type’s publicly accessible website.

Before expenditure of funds under a PHS-funded research project, Bold Type will make available, in response to any written request within five business days, information concerning any SFI disclosed to Bold Type that meets the following criteria: (a) the SFI was disclosed and is still held by a Senior/Key Person; (b) Bold Type determines that the SFI is related to the PHS-funded research; and (c) Bold Type determines that the SFI is an FCOI. The information made available will include, at 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 SFI is held; the nature of the SFI; and the approximate dollar value of the SFI (in the ranges specified by the FCOI Regulation), or a statement that the interest is one whose value cannot be readily determined. The written response will note that the information is current as of the date of the response and is subject to updates on at least an annual basis and within 60 days of Bold Type’s identification of a new FCOI, which will be made available in any subsequent written response. Bold Type will make the information available for at least three years from the date the information was most recently updated.

Written requests should be directed to the Designated Official at the Company’s business address or at finance@boldtype.com.

12. Clinical Research

In any case in which HHS determines that a PHS-funded research project of clinical research 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 an FCOI that was not managed or reported by Bold Type as required by the FCOI Regulation, Bold Type will require the Investigator involved to disclose the FCOI in each public presentation of the results of the research and to request an addendum to previously published presentations.

13. Enforcement and Sanctions

Failure by an Investigator to comply with this policy, including failure to disclose an SFI, failure to complete required training, or failure to comply with a management plan, may result in disciplinary action up to and including removal from the research project, termination of employment or engagement, and referral to NIH as required by the FCOI Regulation. Bold Type will take corrective action for any noncompliance and will promptly notify NIH where required by Section 9.

14. Record Retention

Bold Type will maintain records relating to all Investigator SFI disclosures, Bold Type’s review of and response to such disclosures (whether or not a disclosure resulted in a determination of an FCOI), and all actions under this policy or under any management plan, for at least three years from the date the final expenditures report is submitted to the PHS, or from other dates specified in 2 CFR 200.334 (formerly 45 CFR 75.361) where applicable, including the resolution of any litigation, claim, or audit.

15. Cooperation with HHS

Bold Type will make FCOI-related information, including SFI disclosures and related institutional reviews and determinations, available to HHS promptly upon request. Bold Type acknowledges that HHS may inquire at any time into any Investigator disclosure of financial interests and Bold Type’s review of, and response to, such disclosure, and that HHS may require Bold Type to submit or make available information on all SFIs, whether or not an FCOI was determined.

16. Certification

By signature of the Authorized Organizational Representative on each application for PHS funding, Bold Type certifies that it has in effect an up-to-date, written, enforced administrative process to identify and manage FCOI with respect to all research projects for which PHS funding is sought or received; that it will promote and enforce Investigator compliance with the FCOI Regulation, including those pertaining to disclosure of SFIs; that it will manage FCOIs and provide initial and ongoing FCOI reports to NIH; that it agrees to make information available promptly on request to HHS relating to any Investigator disclosure of financial interests and Bold Type’s review of, and response to, such disclosure, whether or not the disclosure resulted in an FCOI determination; and that it will fully comply with the requirements of the FCOI Regulation.

Approved:

Approval

Approved and signed by Jose L. Bohorquez, PhD, President and CEO, Bold Type LLC, on September 23, 2026.

Requests for Information

Written requests for information about financial conflicts of interest held by senior/key personnel on PHS-funded research, as described in Section 11, may be sent to finance@boldtype.com. Bold Type responds within five business days.