Charles D. Smith, Ph.D.
President and CEO
Apogee Biotechnology Corporation
1214 Research Blvd, Suite 2015
Hershey Center for Applied Research
Hummelstown, PA 17036
Email: cdsmith@apogee-biotech.com
Lynn W. Maines, Ph.D., M.B.A.
Vice President, Research and Business Affairs
Apogee Biotechnology Corporation
1214 Research Blvd, Suite 2015
Hershey Center for Applied Research
Hummelstown, PA 17036
Email: lwmaines@apogee-biotech.com
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Silvan Lutkewitte
Director, Business Development
Apogee Biotechnology Corporation
1214 Research Blvd, Suite 2015
Hershey Center for Applied Research
Hummelstown, PA 17036
Phone: (717) 571-2402
Email: sil_lutkewitte@apogee-biotech.com
Policies
POLICY ON FINANCIAL CONFLICTS OF INTEREST IN PUBLIC HEALTH SERVICE FUNDED
RESEARCH
1. PURPOSE
1.1. This Policy entitled “Policy on Financial Conflicts of Interest in Public Health Service Funded
Research” implements Financial Conflicts of Interest (FCOI) disclosure requirements found in 42 CFR
Part 50, Subpart F, “Promoting Objectivity in Research” and 45 CFR Part 94, “Responsible Prospective
Contractors” which are applicable to Research funded by the U.S. Public Health Service (PHS). These
requirements are applicable to all Research projects for which Apogee Biotechnology Corporation
(“Apogee”) applies for, or receives, Research funding from PHS, except for Phase I SBIR or STTR
Research projects.
1.2. This Policy is intended to ensure objectivity in which Research projects are designed, conducted,
or reported by managing any FCOI that occurs between an Investigator’s personal financial interests
and their professional interests with respect to Research conducted with PHS funding. This Policy
establishes a process of disclosure and independent review when an Investigator has a FCOI. If
Apogee determines that such an FCOI might reasonably appear to affect the Research directly and/or
significantly, Apogee will develop a mitigation plan to manage or eliminate the conflict in accordance
with this Policy.
2. SCOPE
2.1. Each Investigator, as defined in the Policy, who will participate, or is participating, in such
Research, must follow this Policy and complete the required training. Subcontractors and consultants
who perform services within the definition of an Investigator must either maintain a policy that complies
with the requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94 or comply with this Policy.
Questions and concerns regarding this Policy should be directed to the Apogee IO.
3. DEFINITIONS
3.1. Apogee’s Institutional Official (“Apogee IO”) is an official designated by Apogee to solicit and
review completed Disclosure Forms from each Investigator who is planning to participate in, or who is
participating in, PHS funded Research and to determine whether any reported SFI is a FCOI.
References to the Apogee IO in this document include their delegate. The current Apogee IO is Dr.
Charles D. Smith.
3.2. Financial Conflict of Interest (“FCOI”) is a Significant Financial Interest (SFI) that could directly
and significantly affect the design, conduct or reporting of PHS funded Research.
3.3. “Financial interest” means anything of monetary value, whether or not the value is readily
ascertainable.
3.4. “Institutional Responsibilities” means an Investigator’s professional responsibilities performed
on behalf of Apogee, and as defined by Apogee in this Policy, which may include for example: activities
such as research, research consultation, teaching, professional practice, committee memberships, and
service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
3.5. “Investigator” is any individual, regardless of title or position, who is responsible for the design,
conduct, or reporting of Research funded by the PHS, or proposed such funding, including
investigators, consultants, and subcontractors.
3.6. “PD/Pl” means a project director or principal investigator of a PHS-funded Research project; the
PD/Pl is included in the definitions of Senior/Key Personnel and Investigator.
3.7. “PHS Awarding Component” means the organizational unit of the PHS that funds the Research.
3.8. “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 as well as product development
(e.g., a diagnostic test or drug) and 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.
3.9. “Senior/Key Personnel” means the PD/PI and any other person identified as senior or key
personnel staff by Apogee in the grant application, proposal or any other report submitted to the PHS
Awarding Component.
3.10. Significant Financial Interest (“SFI”) means the following:
3.10.1. 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 appears to be related to the
Investigator’s Institutional Responsibilities:
3.10.1.1. With regard to any publicly traded entity, a SFI exists if the value of any remuneration
received from the entity in the twelve (12) 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, warrant, or other ownership interest, as determined through reference to public prices or other
reasonable measures of fair market value;
3.10.1.2. With regard to any non-publicly traded entity, a 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 (e.g., stock, stock option, warrant, or other ownership interest); or,
3.10.1.3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income
related to such rights and interests.
3.10.2. 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.
3.10.3. The term SFI does not include the following types of financial interests: salary, royalties, or
other remuneration paid by Apogee to the Investigator if the Investigator is currently employed by
Apogee, including intellectual property rights assigned to Apogee and agreements to share in royalties
related to such rights; any ownership interest in Apogee held by the Investigator; 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.
3.11. 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.
4. TRAINING REQUIREMENTS
4.1. Each Investigator must complete training prior to engaging in PHS funded research. Acceptable
forms of training include, but are not limited to, the NIH Office of Extramural Research FCOI online
tutorial (located at: grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.html) or other training courses
approved by Apogee.
4.2. Investigators must complete training at least every four years and must immediately complete
training under the following circumstances:
4.2.1. Apogee’s FCOI policy changes in a manner that affects the requirements of Investigators;
4.2.2. An Investigator is new to Apogee; or,
4.2.3. Apogee determines that an Investigator is not in compliance with Apogee’s FCOI policy or
management plan.
5. DISCLOSURE REQUIREMENTS
5.1. Each Investigator who is planning to participate in PHS funded Research is required to disclose to
Apogee any SFIs, including any SFI of their spouse or dependent children, no later than the time of
application for PHS funded Research.
5.2. Each Investigator who is participating in the PHS-funded Research is required to submit an
updated disclosure of SFIs (including any SFI of their spouse or dependent children): (1) at least
annually, in accordance with the specific time period prescribed by Apogee, during the period of the
award; and, (2) within thirty (30) days of discovering or acquiring (e.g., through purchase, marriage, or
inheritance) a new SFI.
5.3. If an Investigator does not have any SFIs to report, the Investigator must still complete the
Disclosure Form both initially and annually. Each Investigator must do so by completing the Disclosure
Form provided by Apogee to the Apogee IO. The Apogee IO shall solicit and review all required
Disclosure Forms and determine whether any reported SFI is a FCOI.
5.4. Apogee shall ensure applicable staff comply with these disclosure obligations. Failure to comply
with these disclosure obligations may result in disciplinary action by Apogee.
6. REVIEW AND MANAGEMENT REQUIREMENTS
6.1. An Investigator’s SFI is related to PHS-funded Research when Apogee, through the Apogee IO,
reasonably determines that the SFI: could be affected by the PHS-funded Research; or is in an entity
whose financial interest could be affected by the Research. Apogee may involve the Investigator in the
Apogee IO’s determination of whether a SFI is related to the PHS-funded Research. A FCOI exists
when Apogee, through the Apogee IO, reasonably determines that the SFI could directly and
significantly affect the design, conduct, or reporting of the PHS-funded Research.
6.2. The Apogee IO will take actions as necessary to manage FCOIs, including any financial conflicts of
a subrecipient Investigator pursuant to this Policy. Management of an identified FCOI requires
development and implementation of a management plan and, if necessary, a retrospective review and
a mitigation report pursuant to this Policy.
6.3. Review Requirement: Prior to Apogee’s expenditure of any funds under a PHS funded Research
project, the Apogee IO will review all Disclosure Forms with SFIs to determine whether the SFIs relate
to the PHS funded Research and whether a FCOI exists. If a FCOI exists, the Apogee IO will develop
and implement a management plan that specifies the actions that have been, and will be, taken to
manage such FCOI. Examples of conditions or restrictions that may be imposed to manage a FCOI
include, but are not limited to the follow actions:
6.3.1. Public disclosure of the FCOI (e.g., when presenting or publishing research);
6.3.2. For Research projects involving human subjects, disclosure of the FCOI directly to participants;
6.3.3. 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;
6.3.4. Modification of the research plan;
6.3.5. Change of personnel or personnel responsibilities, or disqualification of personnel from
participation in all or a portion of the Research;
6.3.6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or,
6.3.7. Severance of relationships that create financial conflicts.
6.4. Disclosure and Identification of SFI: Whenever, in the course of an ongoing PHS funded
Research project: (1) an Investigator who is new to participating in the Research project discloses a
SFI; (2) an existing Investigator discloses a new SFI; or (3) Apogee identifies a SFI that was not
disclosed timely by an Investigator or was not previously reviewed by Apogee during an ongoing PHS
funded Research project, the Apogee IO within sixty (60) days of the disclosure will review the SFI to
determine whether it is related to PHS funded Research and whether a FCOI exists. If a FCOI exists,
the Apogee IO will develop and implement, on at least an interim basis, a management plan that
specifies the actions that have been, and will be, taken to manage such FCOI. Depending on the nature
of the SFI, Apogee may determine that additional interim measures are necessary with regard to the
Investigator’s participation in the PHS funded Research project between the date of disclosure and the
completion of Apogee’s review.
6.5. Retrospective Reviews:
6.5.1. Whenever Apogee identifies a SFI that was not disclosed timely by an Investigator or, for
whatever reason, was not previously reviewed by Apogee during an ongoing PHS-funded research
project (e.g., was not timely reviewed or reported by a subrecipient), the Apogee IO shall, within sixty
(60) days: review the SFI; determine whether it is related to PHS-funded research; determine whether a
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.
6.5.2. In addition, whenever a FCOI is not identified or managed in a timely manner including failure by
the Investigator to disclose a SFI that is determined by the Apogee IO to constitute a FCOI; failure by
the Apogee IO to review or manage such a FCOI; or failure by the Investigator to comply with a FCOI
management plan, Apogee shall, within one hundred twenty (120) days of its determination of
noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded
Research 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.
Apogee is required to document the retrospective review. Documentation shall include all of the
following key elements:
6.5.2.1. Project number;
6.5.2.2. Project title;
6.5.2.3. PD/PI or contact PD/PI if a multiple PD/PI model is used;
6.5.2.4. Name of the Investigator with the FCOI;
6.5.2.5. Name of the entity with which the Investigator has a FCOI;
6.5.2.6. Reason(s) for the retrospective review;
6.5.2.7. Detailed methodology used for the retrospective review (e.g., methodology of the review
process, composition of the review panel, documents reviewed);
6.5.2.8. Findings of the review; and,
6.5.2.9. Conclusions of the review.
6.5.3. Based on the results of the retrospective review, Apogee will update the previously submitted
FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is
found, Apogee will notify the PHS Awarding Component promptly and submit a mitigation report to the
PHS Awarding Component. Minimally, the mitigation report must include the key elements documented
in the retrospective review, a description of the impact of the bias on the Research project, and
Apogee’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,
Apogee will submit FCOI reports annually. Depending on the nature of the FCOI, Apogee 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 FCOI or the Investigator’s
noncompliance is determined and the completion of Apogee’s retrospective review.
6.6. Monitoring: Whenever Apogee implements a management plan, Apogee will monitor Investigator
compliance with the management plan on an ongoing basis until the completion of the PHS funded
Research project.
7. REPORTING OF FINANCIAL CONFLICTS OF INTEREST
7.1. Initial FCOI Report: Prior to Apogee’s expenditure of any funds under a PHS funded Research
project, Apogee will provide to the PHS Awarding Component a FCOI report regarding any
Investigator’s SFI found by Apogee to be a FCOI. Additionally, Apogee will ensure that it has
implemented a management plan in accordance with this Policy. In cases in which Apogee identifies a
FCOI and eliminates it prior to the expenditure of PHS awarded funds, Apogee is not required to submit
a FCOI report to the PHS Awarding Component.
7.2. Subsequent FCOI Reports: For any SFI that Apogee identifies as a FCOI subsequent to
Apogee’s initial report during an ongoing PHS funded Research project, Apogee will provide to the PHS
Awarding Component a FCOI report regarding the FCOI within sixty (60) days of identification of the
FCOI. Additionally, Apogee will ensure that it has implemented a management plan in accordance with
this Policy and, if required, complete a retrospective review and a mitigation report according to this
Policy.
7.3. Contents of a FCOI Report: Any FCOI report required under this Policy will include sufficient
information to enable the PHS Awarding Component to understand the nature and extent of the FCOI
and to assess the appropriateness of Apogee’s management plan. The FCOI report will include the
following minimum information:
7.3.1. Project number;
7.3.2. PD/PI or Contact PD/PI if a multiple PD/PI model is used;
7.3.3. Name of the Investigator with the FCOI;
7.3.4. Name of the entity with which the Investigator has a FCOI;
7.3.5. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
7.3.6. Value of the financial interest (dollar ranges are permissible: $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 readily
be determined through reference to public prices or other reasonable measures of fair market value;
7.3.7. A description of how the financial interest relates to the PHS funded Research and the basis for
Apogee’s determination that the financial interest conflicts with such Research; and,
7.3.8. A description of the key elements of Apogee’s management plan including the following minimum
information:
7.3.8.1. Role and principal duties of the conflicted Investigator in the Research project;
7.3.8.2. Conditions of the management plan;
7.3.8.3. Explanation of how the management plan is designed to safeguard objectivity in the Research
project;
7.3.8.4. Confirmation of the Investigator’s agreement to the management plan; and,
7.3.8.5. Explanation of how the management plan will be monitored to ensure Investigator compliance.
7.4. Annual FCOI Report: For any FCOI previously reported by Apogee regarding an ongoing PHS
funded Research project, Apogee will provide to the PHS Awarding Component an annual FCOI report
that addresses the status of the FCOI and any changes to the management plan for the duration of the
PHS funded Research project. The annual FCOI report will specify whether the FCOI is still being
managed or explain why the FCOI no longer exists. Apogee will 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.
8. ENFORCEMENT
8.1. If the failure of an Investigator to comply with this Policy or a FCOI management plan appears to
have biased the design, conduct, or reporting of the PHS funded Research, Apogee is required to
promptly notify the PHS Awarding Component of the corrective action taken or to be taken by Apogee.
The PHS Awarding Component will consider the situation and, as necessary, take appropriate action,
or refer the matter to Apogee for further action, which may include directions to Apogee on how to
maintain appropriate objectivity in the PHS funded Research project.
8.2. Failure by Apogee staff to comply with this Policy may be grounds for disciplinary action up to and
including termination.
8.3. 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 FCOI that was not managed or reported by
Apogee as required by this subpart, Apogee shall 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.
9. RECORD RETENTION
9.1. Records regarding Disclosure Forms, determinations made by the Apogee IO, and Apogee’s
actions regarding management of a FCOI will be retained by Apogee for three years beyond the date of
the final expenditure report submitted to the PHS Awarding Component under an award or, where
applicable, from other dates specified in 45 CFR 75.361, where applicable.
10. SUBCONTRACTORS AND CONSULTANTS
10.1. Subcontractors/consultants who perform services within the definition of an Investigator must
maintain a policy that complies with the aforementioned regulatory requirements or comply with this
Policy. All applicable subcontract/consulting agreements must contain a clause that requires
compliance with the applicable federal regulations either through a policy maintained by the
subcontractor/consultant or this Policy. Examples of appropriate clauses are shown below:
Financial Conflicts of interest – Compliance with Subcontractor’s Policy
Subcontractor agrees to comply with any and all requirements relating to Public Health Service funded
projects. Without limiting the generality of the foregoing, Subcontractor, its employees and agents
agree to comply with the applicable requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94.
Subcontractor certifies that it maintains a policy that requires compliance with these requirements.
Subcontractor shall report all identified financial conflicts of interests to Apogee immediately and submit
a mitigation plan for Apogee’s review and approval. Apogee is under no obligation to approve a
mitigation plan. Apogee reserves the right to terminate this Agreement or request removal of
Subcontractor’s employee or lower tier subcontractor as a result of Subcontractor, its employee, or
lower tier subcontractor’s financial conflict of interest. Subcontractor must include this clause in its
agreements with any applicable lower tier subcontractors or consultants. Failure to comply with these
requirements is a material breach of this Agreement.
Financial Conflicts of interest – Compliance with Apogee’s Policy
Subcontractor agrees to comply with any and all requirements relating to Public Health Service funded
projects. Without limiting the generality of the foregoing, Subcontractor, its employees and agents
agree to comply with the applicable requirements of 42 CFR Part 50, Subpart F and 45 CFR Part 94.
Subcontractor agrees to comply with Apogee’s Policy on Financial Conflicts of Interest in Public Health
Service Funded Research. Subcontractor shall report all identified financial conflicts of interests to
Apogee immediately and submit a mitigation plan for Apogee’s review and approval. Apogee is under
no obligation to approve a mitigation plan. Apogee reserves the right to terminate this Agreement or
request removal of Subcontractor’s employee or lower tier subcontractor as a result of Subcontractor,
its employee, or lower tier subcontractor’s financial conflict of interest. Subcontractor must include this
clause in its agreements with any applicable lower tier subcontractors or consultants. Failure to comply
with these requirements is a material breach of this Agreement.
11. PUBLIC ACCESSIBILITY
11.1. Prior to Apogee’s expenditure of any funds under a PHS funded Research project, Apogee shall
ensure public accessibility by posting to a publicly accessible website information, or written response
to any requestor within five (5) business days of a request, concerning any SFI disclosed to Apogee
that is: (a) held by Senior/Key Personnel performing services for the Research, (b) related to the PHS
funded research, and (c) determined by Apogee to be a FCOI.
The following information regarding the FCOI must be posted to the website:
11.1.1. Project number;
11.1.2. Name of the Investigator with the FCOI, title, and role with respect to the Research project;
11.1.3. Name of the entity with which the Investigator has a FCOI;
11.1.4. Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
11.1.5. Value of the financial interest (dollar ranges are permissible: $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 readily
be determined through reference to public prices or other reasonable measures of fair market value;
11.2. This information must be updated at least annually as well as within sixty (60) days of either: (a)
Apogee’s receipt or identification of information concerning any additional SFI of the Senior/Key
Personnel for the PHS funded Research project that was not previously disclosed; or, (b) upon
disclosure of any SFI of Senior/Key Personnel new to the PHS funded Research project and meeting
the disclosure criteria. The website shall note that the information is current as of the date shown and is
subject to the required updates. Any SFI posted to the Website shall remain available for at least three
years from the date that the information was most recently updated by Apogee. If Apogee responds to
written requests for the purposes of this subsection, Apogee will note in its written response that the
information provided is current as of the date of the correspondence and is subject to updates, on at
least an annual basis and within sixty (60) days of the Apogee IO’s identification of a new FCOI, which
should be requested subsequently by the requestor. All disclosures or information obtained in reviewing
a potential FCOI is kept confidential, except where disclosure is required by federal regulations.