• Purpose
• Definitions
• Disclosure
• Review by Human Cell Co. COIC
• Guidelines for Determining "Relatedness" and Financial Conflict of Interest
• Management of SIGNIFICANT FINANCIAL INTRESTS That Pose Financial Conflict(s) of interest
• Public Accessibility to Information Related to Financial Conflicts of Interest
• Reporting of Financial Conflicts of Interest
• Training Requirements
• Failure to Comply with Human Cell Co. Conflict of Interest Subaward
• Clinical Research
• Failure to Comply with this POLICY

Purpose

Human Cell Co. is committed to objectivity in research by establishing a Financial Conflict of Interest ("FCOI") policy ("POLICY") with standards that provide a reasonable expectation that the design, conduct, and reporting of research funded or performed under Public Health Service (PHS) grants or cooperative agreements or elsewhere will be free from bias resulting from INVESTIGATOR financial conflicts of interest. This policy is designed to meet the requirements of Federal regulations covering conflicts of interest (42 CFR Part 50 Subpart F for grants and cooperative agreements and 45 CFR Part 94 for contracts).

Definitions

"COMPANY RESPONSIBILITIES" means an INVESTIGATOR's professional activities on behalf of Human Cell Co.. Specifically, these include at least:

Externally sponsored research or scholarly activities (includes activities such as proposing, conducting, and analyzing research and disseminating results); and

Other research (includes participation in study sections, peer review of manuscripts, or effort on non-sponsored research). 

"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 a subaward, or proposed for such funding, which may include, for example, collaborators or consultants. Human Cell Co.' CEO or Scientific Board of Advisors, upon consideration of the individual's role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research and is deemed an INVESTIGATOR. 

"SIGNIFICANT FINANCIAL INTEREST" ["SFI"] means: 

(1) 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 appear to be related to the INVESTIGATOR's COMPANY RESPONSIBILITIES on behalf of Human Cell Co., irrespective of whether the SFI is related to PHS-funded research. 

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 for the investigator, investigator's spouse and dependent children, 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 

With regard to intellectual property rights and interests (e.g., patents, copyrights), a SIGNIFICANT FINANCIAL INTEREST exists upon receipt of income of greater than $5,000 related to such rights and interests. 

(2) In addition, for the INVESTIGATOR only, any reimbursed or SPONSORED TRAVEL (i.e., that which is paid on behalf of the INVESTIGATOR), related to his/her COMPANY RESPONSIBILITIES, must be disclosed to Human Cell Co. 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. This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an U.S. 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. 

(3) The term "SIGNIFICANT FINANCIAL INTEREST" does not include the following types of financial interests: 

Salary, royalties, or other remuneration paid by Human Cell Co. to the INVESTIGATOR if the INVESTIGATOR is currently employed or otherwise appointed by Human Cell Co., including intellectual property rights assigned to the Human Cell Co. 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 an U.S. 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 an U.S. 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. 

"SPONSORED TRAVEL" means any reimbursed or sponsored travel, (i.e. travel that is paid on behalf of the INVESTIGATOR), and that relates to the INVESTIGATOR's COMPANY RESPONSIBILITIES. This definition does not include travel that is paid for or reimbursed 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.

Disclosure

All INVESTIGATORS must disclose their SIGNIFICANT FINANCIAL INTERESTS utilizing the attached form and attaching all required supporting documentation. The completed form and attachments must be submitted to the Human Cell Co.'s Conflict of Interest Committee ("COIC"). The disclosure shall be updated annually, within thirty days of when a SIGNIFICANT FINANCIAL INTEREST or SPONSORED TRAVEL occurs or is discovered, and with the submission of a new application to the PHS Grantee for funding from the PHS Grantee.

Review by Human Cell Co. COIC

The COIC will conduct reviews of disclosures. The COIC will review any SFI that has been identified in a disclosure; these interests will be compared to each research subaward funded under a PHS prime 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 award and, if so, whether the SFI creates a Financial Conflict of Interest ("FCOI") related to that research subaward. 

Guidelines for Determining “Relatedness” and Financial Conflict of Interest

The COIC will determine whether an INVESTIGATOR's SFI is related to the research under a subaward supported by a PHS prime award and, if so, whether the SFI is a financial conflict of interest. An INVESTIGATOR's SFI is related to the research under the subaward when the COIC reasonably determines that the SFI: could be affected by the research conducted under the subaward; or is in an entity whose financial interest could be affected by the research. The COIC may involve the INVESTIGATOR in the determination of whether a SFI is related to the research supported by the subaward. 

A financial conflict of interest exists when the COIC reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. 

In determining if an INVESTIGATOR's SFI is related to the research under a subaward supported by a PHS prime award, and if so, whether the relationship creates a FCOI, the COIC considers the role of the INVESTIGATOR and the opportunity (if any), to bias the results, the nature of the research being proposed, and the value of the SFI in relation to the size and value of the entity. In addition, the COIC may also consider the following factors: 

Whether the research is of a basic or fundamental nature directed at understanding basic scientific processes; or

Whether the degree of replication and verification of research results is such that immediate commercialization or clinical application is not likely; or

Whether the goal of the research is to evaluate an invention linked to the SFI (such as where the SFI is a patent, or an interest in a company that has licensed the invention); or

Where the research involves human subjects, whether there are double blind conditions or the involvement of a data and safety monitoring board; or

Where the SFI is in a privately held company, whether the researcher's SFI could result in the researcher having influence over company decisions, or whether the research could have a significant impact on the company's business or financial outlook (excluding Phase I SBIRs and STTRs); or 

The magnitude of the SFIs (e.g., the amount of consulting, or the percentage or value of equity); or

Where the SFI is in the sponsor of the research, and the sponsor is a licensee of the Discloser's technology, the amount of commercialization payments received by the INVESTIGATOR from that technology, both currently or in the future; or

The number and nature of relationships an INVESTIGATOR has with an entity. Multiple entanglements can create a relationship with an outside entity that is stronger than the sum of the parts; or

Whether the goal of the research is to validate or invalidate a particular approach or methodology that could affect the value of the SFI; or

Whether other scientific groups are independently pursuing similar questions; or

Whether sufficient external review of the research conducted, and the reporting of research results exist to mitigate undue bias; or

Whether the goal of the project is a comparative evaluation of a technology in which an INVESTIGATOR has a SFI; or

Whether the project involves a subaward to an entity in which the INVESTIGATOR has a SFI.

Management of SIGNIFICANT FINANCIAL INTERESTS that Pose Financial Conflict(s) of Interest

If a conflict of interest exists, the COIC will determine by what means – such as the individual's recusal from decisions affecting the conflicting entity, abstention from the external activity, modification of the activity, and/or monitoring of the activity by a subcommittee – the conflict should be avoided or managed in order to mitigate undue bias. In making those determinations, the COIC will be guided by the principles discussed in this POLICY the COIC will also take into consideration whether the INVESTIGATOR's ongoing role is necessary to continue advancing the research, based upon the factors such as the uniqueness of his or her expertise and qualifications.

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); 

For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants; 

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;

For research projects involving human subjects research, use of a data and safety monitoring board; 

Double-blind conditions;

Provisions to conduct the work simultaneously at multiple sites;

Written disclosure of the conflict to all individuals working on the research project;

Annual reports on the research progress to the COIC. 

If the COIC determines that a conflict exists, it will communicate its determination and the means it has identified for eliminating or managing the conflict, in writing, to the individual, to the relevant INVESTIGATOR, and the appropriate direct supervisor. The COIC will keep a record of the disclosure and other relevant information for at least three years. If the COIC prescribes monitoring of the activity, it will describe what monitoring shall be performed and what records are to be kept.

No expenditures on a subaward supported by a PHS prime 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 COIC necessary to manage the Conflict of Interest. The COIC will communicate, in writing, with the PHS Grantee to notify it of the existence and the nature of a Financial Conflict of Interest and whether the conflict has been managed, reduced, or eliminated. No expenditures can be incurred until the PHS Grantee has reported the FCOI to PHS. The PHS Grantee will notify Human Cell Co. when it may incur expenditures.

The COIC will keep a record of INVESTIGATOR disclosures of financial interests and the COIC's review of, and response to, such disclosure and all actions under this POLICY. Such records will be maintained and kept for at least three years from the date the final expenditures report is submitted and in accordance with the terms and conditions of the subaward and relevant PHS Regulations.

Public Accessibility to Information Related to Financial Conflicts of Interest

Prior to the expenditure of any funds under a subaward funded by a PHS prime award, Human Cell Co. will ensure public accessibility, via a publicly accessible Web site or by written response to any requestor within five business days of a request of information concerning any SFI disclosed that meets the following three criteria: 

The SIGNIFICANT FINANCIAL INTEREST was disclosed and is still held by the senior/key personnel. Senior/key personnel are the PD/PI and any other person identified as senior key personnel by Human Cell Co. in the subaward application to the PHS Grantee, progress report or any other report submitted to the PHS Grantee; 

Human Cell Co. has determined that the SIGNIFICANT FINANCIAL INTEREST is related to the research funded through a subaward; and 

Human Cell Co. has determined that the SIGNIFICANT FINANCIAL INTEREST is a financial conflict of interest. 

The information that Human Cell Co. will make available via a publicly accessible Web site or in a written response to any requestor within five days of request will include, at a minimum, the following: 

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 Human Cell Co. publicly accessible Web site 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 PHS-funded research project that had not been previously disclosed, or upon the disclosure of a SIGNIFICANT FINANCIAL INTEREST of a new INVESTIGATOR senior/key personnel, if it is determined by the COIC that the SIGNIFICANT FINANCIAL INTEREST is related to the research and is a financial conflict of interest. 

If Human Cell Co. responds to written requests for the purposes of public accessibility, it will ascertain from the INVESTIGATOR that the information provided is current as of the date of the correspondence, and will note in its written response that the information is subject to updates, on at least an annual basis and within 60 days of the Human Cell Co.' identification of a new financial conflict of interest, which should be requested subsequently by the requestor. 

Information concerning the SIGNIFICANT FINANCIAL INTERESTs of an individual, as limited by this POLICY, will remain available, for responses to written requests or for posting via Human Cell Co.' publicly accessible Web site for at least three years from the date that the information was most recently updated. 

Reporting of Financial Conflicts of Interest

Prior to the expenditure of any funds under a subaward funded by a PHS prime award, Human Cell Co. will provide to the PHS Grantee a FCOI report compliant with PHS regulations regarding any INVESTIGATOR's SIGNIFICANT FINANCIAL INTEREST found to be conflicting and will ensure that the INVESTIGATOR has agreed to and implemented the corresponding management plan. Human Cell Co. cannot incur expenditures until it has received notification to do so from the PHS Grantee.

While the subaward is ongoing (including any extensions with or without funds), Human Cell Co. will provide to the PHS Grantee an annual FCOI report that addresses the status of the FCOI and any changes in the management plan.

For any SIGNIFICANT FINANCIAL INTEREST that is identified as conflicting subsequent to an 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), Human Cell Co. will provide to the PHS Grantee, within forty five days, an FCOI report regarding the financial conflict of interest and ensure that Human Cell Co. has implemented a management plan and the INVESTIGATOR has agreed to the relevant management plan. 

Training Requirements

Each INVESTIGATOR must complete training on Human Cell Co. Conflict of Interest Policy Applicable to A Subaward Issued Under A Public Health Services Prime Award prior to engaging in research related to any PHS-funded subaward and at least every four years, and immediately (as defined below) when any of the following circumstances apply: 

Human Cell Co. revises this POLICY, or procedures related to this POLICY, in any manner that affects the requirements of INVESTIGATORS (training is to be completed within the timeframe specified in communications announcing such changes); 

An INVESTIGATOR is new to Human Cell Co. research under a subaward issued under a PHS prime award (training is to be completed prior to his/her participation in the research); or 

Human Cell Co. 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 COIC). 

In fulfillment of the training requirement, Human Cell Co. requires its investigators to complete the National Institutes of Health's Financial Conflict of Interest tutorial located at: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm 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. 

Failure to Comply with Human Cell Co.' Conflict of Interest Policy Applicable to Public Health Service Funded Subaward 

When a FCOI is not identified or managed in a timely manner, including, for example, because the underlying SIGNIFICANT FINANCIAL INTEREST is not disclosed timely by an INVESTIGATOR or, because a FCOI was not timely reviewed or reported by a second tier subrecipient or by Human Cell Co.; or because an investigator failed to comply with a management plan; then Human Cell Co. will within 120 days: 

Complete a retrospective review of the INVESTIGATOR's activities and the research project to determine any bias in the design, conduct or reporting of research;

Document the retrospective review consistent with the regulation;

Document Human Cell Co.' determination as to whether any research, or portion thereof, conducted during the period of time of the INVESTIGATOR's non-compliance with this POLICY or a Financial Conflict of Interest management plan, was biased in the design, conduct, or reporting of such research; and Notify the PHS Grantee in writing. 

The Institution shall document the retrospective review which must include at least the following key elements: 

Project number;

Project title;

PD/PI or contact PD/PI if a multiple PD/PI model is used;

Name of the Investigator with the FCOI;

Name of the entity with which the Investigator has a financial conflict of interest

Reason(s) for the retrospective review;

Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);

Findings of the review; and

Conclusions of the review.

If bias is found, Human Cell Co. shall notify the PHS Grantee promptly and submit a mitigation report to the PHS Grantee that shall address the following:

Impact of the bias on the research project and 

Human Cell Co.' plan of action or actions taken to eliminate or mitigate the effect of the bias. 

Thereafter, Human Cell Co. shall submit FCOI reports annually to the PHS Grantee, in accordance with the regulation and terms and conditions of the subaward agreement. Depending on the nature of the Financial Conflict of Interest, Human Cell Co. 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 Human Cell Co.' independent retrospective review. 

Clinical Research

If the PHS Grantee 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 Human Cell Co., 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. 

Failure to Comply with This POLICY

No expenditure of funds on a subaward supported by a PHS prime award will be permitted unless the INVESTIGATOR has complied with the Disclosure requirements of this POLICY and has agreed, in writing, to comply with any COIC-approved FCOI management plan.

Any failure by an individual to adhere to this POLICY may be cause for disciplinary action, including, in severe cases, termination. Human Cell Co. shall follow Federal regulations regarding the notification of the sponsoring agency in the event an INVESTIGATOR has failed to comply with this POLICY. Any questions regarding this policy should be addressed to one or all of the following: 

Dr. Soon Seog Jeong

President, Human Cell Co.

sjeong@humancellinc.com