ClearNano Inc

Financial Conflict of Interest (FCOI) Policy

9/15/2021

1. Introduction

(a) ClearNano has established the following Financial Conflict of Interest Policy to maintain compliance with federal laws and regulations governing financial conflicts of interest for publicly funded research and ensure public trust in the integrity of our research activities conducted by ClearNano and its employees, contractors and consultants.

(b) ClearNano will comply with the regulations implemented by the Public Health Services (PHS) (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) (“FCOI Regulations”) to maintain public trust in the integrity of our research activities.

(c) All the investigators ClearNano who are working on Public Health Services (“PHS”), National Institutes of Health (“NIH”), or National Science Foundation (“NSF”) funded research must disclose significant financial interests (SFIs) that are related to the Investigator’s institutional responsibilities. This policy describes certain legal framework to identify, evaluate and correct or remove real, apparent and potential conflicts of interest.

(d) If a project is involved with Subrecipients, ClearNano shall have a written agreement that ensure a Subrecipient will follow the FCOI policy of ClearNanno s or the FCOI policy of the Subrecipient. ClearNano shall obtain a certification from a subawardee that its FCOI policy complies with FCOI Regulations of PHS (Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought) (“FCOI Regulations”).

2. Definitions (42 CFR § 50.603)

(a) Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to ClearNano Inc.

(b) Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

(c) Financial interest means anything of monetary value, whether or not the value is readily ascertainable.

(d) FCOI report means ClearNano Inc 's report of a financial conflict of interest to a PHS Awarding Component.

(e) HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

(f) Institution means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.

(g) ClearNano Inc responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

(h) Investigator means 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 the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

(i) 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.

(j) PD/PI means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.

(k) 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 involved may be delegated, including the National Institutes of Health (NIH).

(l) PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart. Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.

(m) Research means 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 drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

(n) Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.

(o) Significant financial interest 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: With regard to any 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. For purposes of this definition, 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; With regard to any 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); or Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

(p) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is 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 their institutional responsibilities; provided, however, that 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 Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

(q) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by ClearNano to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; 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 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; or income from service on advisory committees or review panels for 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.

(r) Small Business Innovation Research (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.

(s) Signaling Official(s): means a person designated by ClearNano to determine whether an Investigator’s Significant Financial Interest is related to PHS-funded research, and if related, whether the Significant Financial Interest is a Financial Conflict of Interest.

(t) Subrecipient: means an individual or entity receiving federal funds that have come from or through ClearNano to conduct a substantive portion of the PHS-funded research and is accountable to ClearNano for programmatic outcomes and compliance matters.

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3. Investigator Training Requirements

(a) All the ClearNano’s employees, or consultant engaged by ClearNano, who will be responsible for the design, conduct or reporting of PHS funded research, will be trained prior to engaging in any PHS-funded Research and then periodically, but no less than once every four years and immediately under the designated circumstances: (1) ClearNano FCOI policies change in a manner that affects investigator requirements, (2) an investigator is new to ClearNano, or (3) ClearNano finds an investigator noncompliant with ClearNano’s FCOI policy. “Immediately” shall mean the training is provided or made accessible and the investigators participate in the training expeditiously following the event that triggers the training requirement

(b) All PHS-funded “investigators” must complete online FCOI training prior to the expenditure of funds on any newly-funded projects, including noncompeting continuation awards. Each such Investigator is required to provide documentation that they have completed the NIH FCOI tutorial available at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html ·

(c)The Signaling Official is responsible for ensuring that each investigator is informed about (i) this FCOI Policy, (ii) the investigator’s responsibilities regarding disclosure of significant financial interests relating to the investigator’s institutional responsibilities and (iii) the FCOI Regulations.

4. Disclosure, Review, Monitor and Manage Requirements

4.1. Disclosure:

(a) Each Investigator who is planning to participate in the PHS-funded research disclose to the ClearNano’s designated official(s) the Investigator’s significant financial interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS funded research;

(b) Each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the ClearNano, during the period of the award. Such disclosure shall include any information that was not disclosed initially to ClearNano pursuant to paragraph of this section, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest);

(c) Each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

4.2. Review:

Prior to the expenditure of funds or, with respect to an ongoing PHS-funded project, within 60 days of the disclosure or discovery of a significant financial interest,

(a) The Designed Official at ClearNano will determine whether an Investigator’s significant financial interest is related to PHS-funded research according to this policy, and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to PHS-funded research when ClearNano, through its designated official(s), reasonably determines that the significant financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research.

(b) ClearNano may involve the Investigator in the designated official( s)’s determination of whether a significant financial interest is related to the PHS-funded research. A financial conflict of interest exists when ClearNano, through its designated official( s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS funded research.

(c) In the case of a FCOI, the Designed Official at ClearNano will develop and implement a management plan specifying actions that have been and shall be taken to manage the FCOI; and submit initial and ongoing FCOI reports to the PHS Awarding Component as required under the FCOI Regulations [§50.605(b)(3), (4)].

4.3 Monitor and Manage:

(a) Prior to ClearNano’s expenditure of any funds under a PHS-funded research project, the designated official( s) of ClearNano shall, consistent with § 50.604(f): review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest.

(b) Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to: (i) Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research); (ii) For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants; (iii) 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;

(c) Whenever Clearnano implements a management plan pursuant to this subpart, ClearNano shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research

(d) Additional Examples of conditions or restrictions that might be imposed to manage an FCOI include, but are not limited to:

1. Modification of the research plan;

2. Change of personnel or personnel responsibilities or disqualification from participation in all or a portion of the research;

3. Reduction or elimination of the financial interest; and/or

4. Severance of relationships that create such conflicts.

For all management plans, the Signing Official shall (1) monitor ongoing investigator compliance and (2) submit annual updates to the PHS Awarding Component at the time and in the manner specified by the PHS Awarding Component, both until the completion of the PHS-funded research project to which the FCOI relates.

If the FCOI is identified and eliminated prior to the expenditure of any PHS-awarded funds, no FCOI report need be submitted.

5. Reporting Requirements to NIH

(a) Prior to ClearNano’s expenditure of any funds under a PHS-funded research project, ClearNano shall provide to the PHS Awarding Component an FCOI report regarding any Investigator’s significant financial interest found by ClearNano to be conflicting and ensure that ClearNano has implemented a management plan. In cases in which ClearNano identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the ClearNano shall not submit an FCOI report to the PHS Awarding Component.

(b) For any significant financial interest that ClearNano identifies as conflicting subsequent to ClearNano’s initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), ClearNano shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that ClearNano has implemented a management plan in accordance with this subpart.

(c) When FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by ClearNano (e.g., was not timely reviewed or reported by a subrecipient), the Institution also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, ClearNano is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

(d) Any FCOI report prepared by ClearNano shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of ClearNano’s management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following: (i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the Investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) Value of the financial interest (dollar ranges are permissible), 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; (vii) A description of how the financial interest relates to the PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research; and (viii) A description of the key elements of the ClearNano’s management plan, including: (A) Role and principal duties of the conflicted Investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the Investigator’s agreement to the management plan; (E) How the management plan will be monitored to ensure Investigator compliance; and (F) Other information as needed.

(e) For any financial conflict of interest previously reported by ClearNano with regard to an ongoing PHS-funded research project, ClearNano shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. ClearNano shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

(f) ClearNano may also report other financial conflicts of interest in its policy on financial conflicts of interest, as the Institution deems appropriate.

(g) Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, i.e., prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.

6. Maintenance of Records

Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under the Institution’s policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

7.Enforcement Mechanisms and Remedies and Noncompliance

7.1 Noncompliance and Remedies

(a) Whenever ClearNano identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days: review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so: (i) 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 financial conflict of interest going forward; (ii)(A) In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by ClearNano to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the ClearNano shall, within 120 days of the Institution’s determination of noncompliance, complete 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 time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

(b) The review shall be documented consistent with the FCOI Regulations [§60.605(a)(3)(ii)(B)]. If bias is found during the course of the review, the Signing Official will promptly notify the PHS Awarding Component (which may take its own action and/or require further action by ClearNano and/or the investigator, as it deems appropriate) and submit a mitigation report consistent with the FCOI Regulations [§60.605(a)(3)(iii)]. If appropriate, the Signing Official will update the previously submitted FCOI report. In any event, the Signing Official shall submit FCOI reports annually thereafter.

(c) For clinical research projects supported by the PHS, if the Department of Health and Human Services determines that a PHS- funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment was designed, conducted, or reported by an investigator with an FCOI that was not properly disclosed or managed as required under the FCOI Regulations, the investigator shall disclose the FCOI in each public presentation of the results of the research (such as articles, manuscripts and oral presentations) and ClearNano shall request an addendum to previously published presentations.

7.2. Enforcement Mechanism and Sanctions

All researchers to whom this FCOI Policy applies are expected to fully and promptly comply with it. The Signing Official may impose sanctions for noncompliance which may include, but is not limited to, the following:

• Failure to make timely, full or accurate disclosures;

• Failure to provide information requested;

• Failure to update a disclosure form as necessary; or

• Failure to comply with a management plan.

For ClearNano employees, sanctions may include suspension or dismissal, denial of eligibility to engage in the research at issue or other appropriate penalties. Such sanctions may require giving notice of relevant information to funding agencies, professional bodies or journals, or the public. The Signing Official will determine what sanctions, if any, are to be applied.

8. Retrospective Review Requirements

(a) Maintain records relating to all Investigator disclosures of financial interests and ClearNano’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of a financial conflict of interest) and all actions under ClearNano’s policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in 45 CFR 75.361 for different situations.

(b) Whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by ClearNano to constitute a financial conflict of interest; failure by ClearNano to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, ClearNano shall, within 120 days of the Institution’s determination of noncompliance, complete 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 time period of the noncompliance, was biased in the design, conduct, or reporting of such research.

(c) ClearNano is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the Investigator with the FCOI; (5) Name of the entity with which the Investigator has a financial conflict of interest; (6) Reason(s) for the retrospective review; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review. (iii) Based on the results of the retrospective review, if appropriate, ClearNano shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and ClearNano’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., 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, ClearNano will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator’s noncompliance is determined and the completion of ClearNano’s retrospective review.

9. Subrecipient Requirements

(a) If ClearNano carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), ClearNano will take the following steps to ensure that any subrecipient Investigator complies with this subpart by: (1) Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient’s Investigators.

(b) If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of ClearNano for disclosing significant financial interests that are directly related to the subrecipient’s work for ClearNano;

(c) If the subrecipient’s Investigators must comply with the subrecipient’s financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to ClearNano. Such time period( s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;

(d) If the subrecipient’s Investigators must comply with the awardee Institution’s financial conflicts of interest policy, the agreement referenced above shall specify time period( s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart.

10. Public Accessibility Requirements

ClearNano shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this subpart, and make such policy available via a publicly accessible Web site. If ClearNano does not have any current presence on a publicly accessible Web site (and only in those cases), ClearNano will make its written policy available to any requestor within five business days of a request. If, however, ClearNano acquires a presence on a publicly accessible Web site during the time of the PHS award, ClearNano will post the information on that Web site within 30 calendar days. Such information shall consist of that required to be provided under the FCOI Regulations [§50.605(a)(5)(ii), (iii)], shall be updated at least annually and within 60 days of the receipt or identification of information concerning an additional significant financial interest, and shall remain available for three years from the date the information was most recently updated.

11. Clinical Research

(a) In any case in which the HHS determines that a PHS-funded 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 a financial conflict of interest that was not managed or reported by ClearNano as required by this subpart, ClearNano 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.

12.Additional Information

ClearNano may be asked to provide records related to this FCOI Policy, including disclosure forms, to the Department of Health and Human Services or other federal agencies or entities. ClearNano will provide the requested information and make any other disclosures necessary to comply with this FCOI Policy or as required by law. Such records may be requested and provided whether or not the disclosure resulted in a determination that an FCOI existed.