Research Administration
For Scientists
COMP 290-083
Tim Quigg
Class 15: April 21
• University/Industry Research
Collaboration Issues
University/Industry Research
Collaboration Issues
1. NDA/CDA/PIA
2. Licensing Agreements
3. Industry-Sponsored Research
4. Conflict of Interest
Non-Disclosure Agreements
One or Two Way
PROPRIETARY INFORMATION EXCHANGE AGREEMENT
This Agreement is entered into by and between Corporation, a corporation organized and existing
under the laws of Delaware, by and through its Electronic Systems, having offices at Baltimore,
Maryland (hereinafter referred to as “Corporation”) and the University of North Carolina, Chapel Hill,
a corporation organized and existing under the laws of
by and through its
Division, having
offices at 245 Sitterson Hall, UNC Chapel Hill, NC 27599 (hereinafter referred to as “UNC ”).
Subject of Corporation information: Strategy and proposal information for DARPA Class Program.
Subject of UNC information: Strategy and proposal information for DARPA Class Program.
Purpose of exchange: To enable teaming discussions for the DARPA Class Program.
The parties hereto desire to exchange the information described above, and considered by them to
be proprietary, for the above-stated purpose. The party furnishing the proprietary information will be
referred to as the “Disclosing Party” and the party receiving the proprietary information will be
referred to as the “Receiving Party”. In order to provide for the protection of such proprietary
information from unauthorized use and disclosure, the parties hereby agree that the disclosure of
such information between them shall be subject to the following terms and conditions:
Non-Disclosure Agreements
Definition of Confidential Information
1.
Only that information disclosed in written form and identified by a marking thereon as
proprietary, or oral information which is identified as proprietary at the time of disclosure and
confirmed in writing within thirty (30) days of its disclosure, shall be considered proprietary
and subject to this Agreement.
2.
The exclusive points of contact with respect to the delivery and control of proprietary
information disclosed hereunder are designated by the parties as follows:
UNC:
Faculty Member name, address and phone
Corporation:
Contact name, address and phone
Either party may change its point of contact by written notice to the other.
Non-Disclosure Agreements
Duration
3.
Information identified and disclosed as provided in this Agreement shall be held by the
Receiving Party in confidence for a period of 5 year(s) from the date of receipt. During such
period, such information shall be used only for the purpose stated above and shall not be
disclosed to any third party. Neither party shall be liable for disclosure pursuant to judicial
action or government regulation or requirement, provided that the originating party is given
prompt notice of such government or judicial action and is afforded an opportunity to respond
prior to disclosure by the Receiving Party.
Non-Disclosure Agreements
Degree of Care
4.
5.
The parties shall have no obligation under this Agreement to hold information in confidence
which, although identified and disclosed as stated herein, has been or is:
a)
developed by the Receiving Party independently and without the benefit of information
disclosed hereunder by the Disclosing Party;
b)
lawfully obtained by the Receiving Party from a third party without restriction;
c)
publicly available without breach of this Agreement;
d)
disclosed without restriction by the Disclosing Party to a third party, including the
United States Government; or
e)
known to the Receiving Party prior to its receipt from the Disclosing Party.
Each party shall use not less than the degree of care used to prevent disclosure of its own
proprietary information to prevent disclosure of information received in accordance with this
Agreement. In no event, however, shall less than a reasonable standard of care be used.
Non-Disclosure Agreements
Export Control
6.
All information received and identified in accordance with this Agreement shall remain the
property of the Disclosing Party and shall be returned upon request. Nothing contained herein
shall be construed as a right or license, express or implied, under any patent copyright, or
application therefore, of either party by or to the other party.
7.
Any U. S. Government classified information disclosed by one party to the other shall be
handled in accordance with the Department of Defense Industrial Security Manual for
Safeguarding Classified Information (DoD 5220.22-M) or the National Industrial Security
Program Operating Manual (NISPOM), their supplements, and other applicable U. S.
Government security regulations.
8.
The Receiving Party represents and warrants that no technical data delivered to it by the
Disclosing Party shall be exported from the United States without first complying with all
requirements of the International Traffic in Arms Regulations and the Export Administration
Act, including the requirement for obtaining any export license, if applicable. The Receiving
Party shall first obtain the written consent of the Disclosing Party prior to submitting any
request for authority to export any such technical data.
Non-Disclosure Agreements
Governing Law – Authorized Signature
9.
The terms and conditions herein constitute the entire agreement and understanding of the
parties and shall supersede all communications, negotiations, arrangements and agreements,
either oral or written, with respect to the subject matter hereof. No amendments to or
modifications of this Agreement shall be effective unless reduced to writing and executed by
the Parties hereto. The failure of either party to enforce any term hereof shall not be deemed a
waiver of any rights contained herein.
10.
The effective date of this Agreement shall be the date of the last signature below. This
Agreement shall expire one (1) year from the effective date hereof unless extended in writing
by the parties hereto. The obligations of the parties contained in paragraph 3 above shall
continue in effect notwithstanding the expiration of this Agreement.
11.
This Agreement shall be governed and interpreted in accordance with the laws of the State of
Maryland except its rules in regard to choice of laws.
CORPORATION
UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL
BY:
BY:
TYPED NAME:
TYPED NAME:
TITLE:
TITLE:
DATE:
DATE:
AGREEMENT NO.:
University/Industry Research
Collaboration Issues
1. NDA/CDA/PIA
2. Licensing Agreements
Licensing Agreement
THIS LICENSE AGREEMENT is made and entered into this ___ day of _______, 199__ between THE
UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL having an address at CB #4105, 308 Bynum Hall, Chapel Hill,
N.C. (hereinafter referred to as University) and _________________ , a corporation organized and existing under the
laws of _________ and having an address at ____________________________________, (hereinafter referred to as
Licensee).
WITNESSETH
WHEREAS, University owns and controls an invention known as " ________"; file #OTD ______ (hereafter,
"Invention"); and
WHEREAS, the Invention was developed by __________ (hereafter, "Inventor"), of the University; and
WHEREAS, Licensee is desirous of producing, using and selling products which include the use of Invention
and is willing to expend its best efforts and resources to do so if it can obtain a license to use the Invention under
the terms and conditions set forth herein; and
WHEREAS, University desires to facilitate a timely transfer of its information and technology concerning the
Invention for the ultimate benefit of the public and this transfer is best accomplished by the grant of this license; and
WHEREAS, in the opinion of the University, this transfer can best be accomplished consistent with its mission
by affiliation with Licensee;
NOW, THEREFORE, for and in consideration of the covenants, conditions, and undertakings hereinafter set
forth, it is agreed by and between the parties as follows:
Licensing Agreement
1.
Definitions
1.1 "University Technology" means any unpublished research and development information, know-how, and
technical data in the possession of the Inventor prior to the effective date of this Agreement which relates to and is
necessary for the practice of the Invention and which University has the right to provide to Licensee.
l.2 "Licensed Products" means any method, procedure, product, or component part thereof whose
manufacture or sale includes any use of University Technology or Patent Rights.
1.3 "Patent Rights" means any U.S. patents and/or patent applications covering the Invention owned or
controlled by University prior to or during the term of this Agreement and which University has the right to provide to
Licensee, as well as any continuations, continuations in part, divisionals, provisionals, continued prosecution
applications, or reissues thereof, and any foreign counterpart of any of the foregoing.
1.4 "Net Sales Price" means the invoiced sales price, less any charges for (a) sales taxes or other taxes
separately stated on the invoice and (b) shipping and insurance charges.
1.5 "Net Sales" means the total Net Sales Price of Licensed Products, after deducting actual allowances for
returned or defective goods, less trade discounts, but before cash discounts. Licensed Products will be considered
sold when billed out, or when delivered or paid for before delivery, whichever first occurs.
1.6 "Licensed Territory" means ___________________.
1.7 "Licensed Field" means, and is limited to, the practice of the Invention for _________________.
Licensing Agreement
2.
Grant of License and Term
2.1 University grants to Licensee to the extent of the Licensed Territory a non-exclusive right and license to
use University Technology in the Licensed Field, subject to all the terms and conditions of this Agreement.
2.2 University grants to Licensee to the extent of the Licensed Territory, an exclusive license under the
Patent Rights and the right to make, use and sell Licensed Products in the Licensed Field, upon the terms and
conditions set forth herein.
2.3 Any license granted herein is exclusive for a term beginning on the date of execution of this Agreement
and, unless terminated sooner as herein provided, ending at the expiration of the last to expire patent included in the
Patent Rights, or if no patents mature from said Patent Rights, such license shall terminate 15 years from the date of
its commencement.
2.4 Licensee shall not disclose any unpublished University Technology furnished by University pursuant to
Paragraph 2.1 above to third parties during the term of this Agreement or any time thereafter, provided, however, that
disclosure may be made of any such University Technology at any time: (1) with the prior written consent of
University, or (2) after the same shall have become public through no fault of Licensee.
2.5 Notwithstanding the foregoing, any and all licenses granted hereunder are subject to the rights of the
United States Government which arise out of its sponsorship of the research which led to the Invention.
Licensing Agreement
3.
License Fee and Royalties
3.1 Licensee shall pay to University a license issue fee in the amount of _______________. Licensee will
pay a further license fee in the form of reimbursement of the costs (including attorney's fees) arising out of the
patenting of the Invention pursuant to Article 9 of this Agreement. Both the license issue fee and the reimbursement
of patenting costs shall be non-refundable and shall not be a credit against any other amounts due hereunder except
as may be provided for elsewhere in this Agreement. Reimbursement of patenting costs shall be due upon monthly
billings from University.
3.2 Beginning on the effective date of this Agreement and continuing for the life of this Agreement, Licensee
will pay University a running royalty of ___________ of all Net Sales of the Licensed Product(s).
3.3 Licensee agrees to make quarterly written reports to University within 30 days after the first days of each
January, April, July, and October during the life of this Agreement and as of such dates, stating in each such report
the number, description, and aggregate Net Selling Prices of Licensed Products sold or otherwise disposed of during
the preceding three calendar months and upon which royalty is payable as provided in Article 3.2 hereof. The first
such report shall include all such Licensed Products so sold or otherwise disposed of prior to the date of such report.
Until Licensee has achieved a first commercial sale of a Licensed Product a report shall be submitted by Licensee at
the end of each January, April, July and October after the effective date of this Agreement and will include a full
written report describing Licensee’s technical and other efforts made towards such first commercial sale for all
Licensed Products under development.
Licensing Agreement
3.
License Fee and Royalties
3.4 Concurrently with the making of each such report, Licensee shall pay to the University royalties at the
rate specified in Article 3.2 of this Agreement on the Licensed Products included therein.
3.5 If in any calendar year during the term of this Agreement, total amounts payable under Paragraph 3.2
hereof are less than the minimum amount indicated in the Schedule below corresponding to such calendar year,
Licensee shall pay the University within thirty (30) days after the end of such calendar year, the difference between the
amounts payable for such calendar year and said minimum amount.
SCHEDULE
Calendar Year
199__
199__
199__
199__ and all
subsequent years
Minimum Amounts
3.6 Should this Agreement become effective or terminate or expire during a calendar year, the minimum
royalty under paragraph 3.5 for such portion of a year shall be determined by multiplying the minimum royalty set
forth in said paragraph for the year in which this Agreement becomes effective, terminates or expires, by a fraction,
the numerator of which shall be the number of days during such calendar year for which this agreement shall be in
effect and the denominator of which shall be 365.
Licensing Agreement
3.
License Fee and Royalties
3.7 In the event of default in payment of any payment owing to University under the terms of this
Agreement, and if it becomes necessary for University to undertake legal action to collect said payment, Licensee
shall pay all legal fees and costs incurred by University in connection therewith.
3.8 University may, by written notice to Licensee, terminate this Agreement during any April subsequent to
the year ______________, if Licensee has not practiced the Invention during each calendar year which precedes each
such April to the extent of generating earned royalties under paragraph 3.2 of this Agreement in the amount of
___________________.
4.
Best Efforts
4.1 Licensee shall use its best efforts to proceed diligently with the manufacture and sale of Licensed
Products and shall earnestly and diligently offer and continue to offer for sale such Licensed Products, both under
reasonable conditions, during the period of this Agreement.
4.2 In particular, Licensee will use its best efforts to meet the performance milestones set forth in Appendix
A, which is attached hereto.
Licensing Agreement
5.
Cancellation by University
5.1 It is expressly agreed that, notwithstanding the provisions of any other paragraph of this contract, if
Licensee should fail to deliver to University any royalty at the time or times that the same should be due to University
or if Licensee should in any material respect violate or fail to keep or perform any covenant, condition, or undertaking
of this Agreement on its part to be kept or performed hereunder, then and in such event University shall have the right
to cancel and terminate this Agreement, and the license herein provided for, by written notice to Licensee if Licensee
has failed to cure any such breach within 30 days of receipt of written notice from University describing such breach.
Licensee's right to cure a breach will apply only to the first two breaches properly noticed under terms of this
Agreement, regardless of the nature of those breaches. Any subsequent breach by Licensee will entitle University to
terminate this Agreement upon proper notice.
5.2 Alternatively, should Licensee be in breach or default as set forth above, and should University be in a
position where it could rightfully terminate this Agreement, then in its sole discretion, University may convert this
exclusive license to a non-exclusive license upon giving notice of such decision to Licensee.
5.3 If Licensee should be adjudged bankrupt or enter into a composition with or assignment for the benefit
of its creditors, then in such event University shall have the right to cancel and terminate this Agreement, and the
license herein provided for, by written notice to Licensee.
5.4 Any termination or cancellation under any provision of this Agreement shall not relieve Licensee of its
obligation to pay any royalty or other fees (including attorney's fees pursuant to Article 3.1 hereof) due or owing at the
time of such cancellation or termination.
Licensing Agreement
6.
Disposition of Licensed Products On Hand Upon Cancellation or Termination
6.1 Upon cancellation of this Agreement or upon termination in whole or in part, Licensee shall provide
University with a written inventory of all University Technology and Licensed Products in process of manufacture, in
use or in stock. Except with respect to termination pursuant to Paragraph 5.1, Licensee shall have the privilege of
disposing of the inventory of such Licensed Products within a period of one hundred and eighty (180) days of such
termination upon conditions most favorable to University that Licensee can reasonably obtain. Licensee will also
have the right to complete performance of all contracts requiring use of the University Technology, Patent Rights
(except in the case of termination pursuant to Paragraph 5.1) or Licensed Products within and beyond said 180-day
period provided that the remaining term of any such contract does not exceed one year. All Licensed Products which
are not disposed of as provided above shall be delivered to University or otherwise disposed of, in University's sole
discretion, and at Licensee's sole expense.
7.
Use of University's Name
7.1 The use of the name of University, or any contraction thereof, in any manner in connection with the
exercise of this license is expressly prohibited except with prior written consent of University.
8.
University Use
8.1 It is expressly agreed that, notwithstanding any provisions herein, University is free to use University
Technology, Patent Rights and Licensed Products for its own research, public service, clinical, teaching and
educational purposes without payment of royalties. Furthermore, University shall be free to publish University
Technology, as it sees fit.
Licensing Agreement
9.
Patents and Infringements
9.1 Licensee shall bear the cost of filing and prosecuting U.S. Patent applications included within the Patent
Rights. Such filings and prosecution shall be by counsel of University's choosing and shall be in the name of
University. University shall keep Licensee advised as to the prosecution of such applications by forwarding to
Licensee copies of all official correspondence, (including, but not limited to, Applications, Office Actions, responses,
etc.) relating thereto. Licensee shall have the right to advise University as to such prosecution, and further, shall have
the right to make reasonable requests as to the conduct of such prosecution.
9.2 As regards filing of foreign patent applications corresponding to the U.S. applications described in
paragraph 9.1 above, Licensee shall designate that country or those countries, if any, in which Licensee desires such
corresponding patent application(s) to be filed. Licensee shall pay all costs and legal fees associated with the
preparation and filing of such designated foreign patent applications and such applications shall be in the
University's name. University may elect to file corresponding patent applications in countries other than those
designated by Licensee, but in that event University shall be responsible for all costs associated with such nondesignated filings. In such event, Licensee shall forfeit its rights under this license in the country(ies) where
University exercises its option to file such corresponding patent applications.
Licensing Agreement
9.
Patents and Infringements
9.3 If the production, sale or use of Licensed Products under this Agreement by Licensee results in any
claim for patent infringement against Licensee, Licensee shall promptly notify the University thereof in writing, setting
forth the facts of such claim in reasonable detail. As between the parties to this Agreement, Licensee shall have the
first and primary right and responsibility at its own expense to defend and control the defense of any such claim
against Licensee, by counsel of its own choice. It is understood that any settlement of such actions must be
approved by University. Such approval shall not be unreasonably withheld. University agrees to cooperate with
Licensee in any reasonable manner deemed by Licensee to be necessary in defending any such action. Licensee
shall reimburse University for any out of pocket expenses incurred in providing such assistance.
9.4 In the event that any Patent Rights licensed to Licensee are infringed by a third party, Licensee shall
have the primary right, but not the obligation, to institute, prosecute and control any action or proceeding with
respect to such infringement, by counsel of its choice, including any declaratory judgment action arising from such
infringement.
9.5 Notwithstanding for foregoing, and in University's sole discretion, University shall be entitled to
participate through counsel of its own choosing in any legal action involving the Invention. Nothing in the foregoing
sections shall be construed in any way which would limit the authority of the Attorney General of North Carolina.
Licensing Agreement
10.
Waiver
10.1 It is agreed that no waiver by either party hereto of any breach or default of any of the covenants or
agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.
11.
License Restrictions
11.1 It is agreed that the rights and privileges granted to Licensee are each and all expressly
conditioned upon the faithful performance on the part of the Licensee of every requirement herein contained, and that
each of such conditions and requirements may be and the same are specific license restrictions.
12.
Assignments
12.1 This Agreement is binding upon and shall inure to the benefit of the University, its successors and
assigns. However, this Agreement shall be personal to Licensee and it is not assignable by Licensee to any other
entity without the written consent of University, which consent shall not be withheld unreasonably.
Licensing Agreement
13.
Indemnity
13.1 Licensee agrees to indemnify, hold harmless and defend University, its officers, employees, and
agents, against any and all claims, suits, losses, damage, costs, fees, and expenses asserted by third parties, both
government and private, resulting from or arising out of the exercise of this license.
14.
Insurance
14.1 Licensee is required to maintain in force at its sole cost and expense, with reputable insurance
companies, general liability insurance and products liability insurance coverage in an amount reasonably sufficient to
protect against liability under paragraph 13, above. The University shall have the right to ascertain from time to time
that such coverage exists, such right to be exercised in a reasonable manner.
15.
Independent Contractor Status.
15.1 Neither party hereto is an agent of the other for any purpose.
16.
Late Payments
16.1 In the event royalty payments or fees are not received by University when due, Licensee shall pay to
University interest and charges at the maximum rate of interest allowed by law on the total royalties or fees due.
Licensing Agreement
17.
Warranties
17.1 University makes no warranties that any patent will issue on University Technology or Invention.
University further makes no warranties, express or implied as to any matter whatsoever, including, without limitation,
the condition of any invention(s) or product(s), that are the subject of this Agreement; or the merchantability or fitness
for a particular purpose of any such invention or product. University shall not be liable for any direct, consequential,
or other damages suffered by Licensee or any others resulting from the use of the Invention or Licensed Products.
18.
Accounting and Records
18.1 Licensee will keep complete, true and accurate books of account and records for the purpose of
showing the derivation of all amounts payable to University under this Agreement. Such books and records will be
kept at Licensee's principal place of business for at least three (3) years following the end of the calendar quarter to
which they pertain, and will be open at all reasonable times for inspection by a representative of University for the
purpose of verifying Licensee's royalty statements, or Licensee's compliance in other respects with this Agreement.
The representative will be obliged to treat as confidential all relevant matters.
18.2 Such inspections shall be at the expense of University, unless a variation or error exceeding U.S.
$1,000, or the equivalent, is discovered in the course of any such inspection, whereupon all costs relating thereto paid
by Licensee.
18.3 Licensee will promptly pay to University the full amount of any underpayment, together with interest
thereon at the maximum rate of interest allowed by law.
Licensing Agreement
19.
Compliance with Laws
19.1 In exercising its rights under this license, Licensee shall fully comply with the requirements of any and
all applicable laws, regulations, rules and orders of any governmental body having jurisdiction over the exercise of
rights under this license. Licensee further agrees to indemnify and hold University harmless from and against any
costs, expenses, attorney's fees, citation, fine, penalty and liability of every kind and nature which might be imposed
by reason of any asserted or established violation of any such laws, order, rules and/or regulations.
20.
U.S. Manufacture
20.1 It is agreed that any Licensed Products sold in the United States shall be substantially manufactured in
the United States.
21.
Notices
21.1 Any notice required or permitted to be given to the parties hereto shall be deemed to have been
properly given if delivered in person or mailed by first-class certified mail to the other party at the appropriate address
as set forth below or to such other addresses as may be designated in writing by the parties from time to time during
the term of this Agreement.
UNIVERSITY
Associate Vice Provost
Office of Technology Development
CB #4105, 308 Bynum Hall
UNC-CH
Chapel Hill, NC 27599-4105
LICENSEE
Licensing Agreement
22.
Governing Laws
22.1 This Agreement shall be interpreted and construed in accordance with the laws of the State of North
Carolina.
23.
Complete Agreement
23.1 It is understood and agreed between University and Licensee that this license constitutes the entire
Agreement, both written and oral, between the parties, and that all prior agreements respecting the subject matter
hereof, either written or oral, expressed or implied, shall be abrogated, canceled, and are null and void and of no
effect.
24.
Severability
24.1 In the event that a court of competent jurisdiction holds any provision of this Agreement to be invalid,
such holding shall have no effect on the remaining provisions of this Agreement, and they shall continue in full force
and effect.
25.
Survival of Terms
25.1 The provisions of Articles 6, 7, 8, 9, 13, 14, 17, 18, 19, 21, 22, and 23 shall survive the expiration or
termination of this Agreement.
Licensing Agreement
IN WITNESS WHEREOF, both University and Licensee have executed this Agreement, in duplicate originals, by their
respective officers hereunto duly authorized, the day and year first above written. Inventors have likewise indicated
their acceptance of the terms hereof by signing below.
THE UNIVERSITY OF NORTH CAROLINA
AT CHAPEL HILL
By:____________________________
By:_____________________
Name:___________________
Associate Vice Provost,
Technology Development
INVENTORS:
__________________________
__________________________
__________________________
Title:__________________
University/Industry Research
Collaboration Issues
1. NDA/CDA/PIA
2. Licensing Agreements
3. Industry-Sponsored Research
•
Unrestricted Gift – Good
•
Sponsored Research Agreement – Be Careful
•
•
IP Clauses
•
Right of First Negotiation/Refusal
•
Publication Clauses
Prime/Sub on Federally Sponsored Research Agreement
•
IP Clauses
•
Appropriate FAR Clauses
•
Cultural Issues
University/Industry Research
Collaboration Issues
1. NDA/CDA/PIA
2. Licensing Agreements
3. Industry-Sponsored Research
4. Conflict of Interest
Conflict of Interest
It’s About Public Trust
• Longstanding interest in objectivity in
research and financial conflict of interest.
• Key Question: “Is the situation likely to
interfere or appear to interfere with the
independent judgment one is supposed to
show as a professional performing official
duties?”
Conflict of Interest
University of Pennsylvania (1999)
• Researchers testing new way to replace
defective genes to treat enzyme disorders. 18
year old Jesse Gelsinger died from the gene
therapy study.
• The university held equity in the company
developing the drug, and the lead doctor held
one-third of its shares of stock.
Conflict of Interest
It’s About Public Trust
• Trust Test
– Would relevant others [employers, clients,
professional colleagues, or the general public]
trust my judgment if they knew I was in this
situation?
Conflict of Interest
• Institutional policy must ensure that investigators
have provided all required financial disclosures at
the time the proposal is submitted to NSF or NIH.
• It must also require that those financial disclosures
are updated during the period of the award, either
on an annual basis, or as new reportable
significant financial interests are obtained.
Conflict of Interest
• NSF requirement – Significant Financial
Interest Disclosure in connection with
research application. Includes faculty
member, spouse or dependent children.
• Management plan required.
• NSF notified only if the institution finds
that it is unable to satisfactorily manage an
actual or potential conflict of interest.
Conflict of Interest
• NIH requirement – Significant Financial
Interest Disclosure in connection with
research application. Includes faculty
member, spouse or dependent children.
• Management plan required.
• Institute Grants Management Officer
notified.
Conflict of Interest
Significant Financial Interest
• PHS Definition (42 CFR 50.603)
– Significant Financial Interest means anything of
monetary value, including but not limited to,
salary or other payments for services; equity
interests; and intellectual property rights.
Conflict of Interest
Significant Financial Interest
• PHS Definition (42 CFR 50.603)
– The term does not include:
• Salary, royalties, or other remuneration from the applicant institution;
• Any ownership interests in the institution, if the institution is an
applicant under the SBIR Program;
• Income from seminars, lectures, or teaching engagements sponsored by
public or nonprofit entities;
• Income from service on advisory committees or review panels for
public or nonprofit entities;
• An equity interest that when aggregated does not exceed $10,000 of
FMV and does not represent more than a 5% ownership interest in any
single entity; or
• Salary, royalties or other payments that when aggregated are not
expected to exceed $10,000.
Conflict of Interest
Significant Financial Interest
• Interest must be either…
– Managed;
– Reduced; or
– Eliminated
• Management Plan
– Include brief, general explanation of actions taken but
• Exclude personal financial data
• Updates
– Conflict of Interest declarations are made annually or as
new SFI’s are obtained
THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
POLICY ON CONFLICTS OF INTEREST AND COMMITMENT
This Policy on Conflicts of Interest and Commitment (hereinafter, the
"Policy") provides guidelines for relationships between the University and its
faculty, staff, and students with private industry, federal and state government,
and the nonprofit sector that will help to assure the primacy of academic
integrity. The University encourages employees to engage in appropriate
outside relationships, but members of the University community are expected
to avoid conflicts of interest that have the potential to directly and significantly
affect the University’s interests, compromise objectivity in carrying out
University responsibilities, or otherwise compromise performance of
University responsibilities, unless such conflicts are disclosed, reviewed, and
managed in accordance with this Policy.
THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
POLICY ON CONFLICTS OF INTEREST AND COMMITMENT
The fact that an individual has a conflict of interest does not imply that the
conflict is unethical or impermissible; it means simply that the relation of the
conflict to the individual’s University responsibilities must be carefully
examined because conflicts of interest - real or perceived - may impair
performance of our missions of teaching, research, and public service, as well
as jeopardize public trust and support.
Examples of Potential Conflicts
CATEGORY I: Activities or relationships that are routinely allowable and are not required to be
disclosed pursuant to the Policy because they do not represent significant potential for
compromising the objectivity of research results, the welfare and rights of human research subjects,
the integrity of faculty-student interactions, or other interests of the University, the sponsor, or the
public*
1.
Receiving royalties for published scholarly works and other materials or for inventions
pursuant to the University's Patent and Copyright Policies.
2.
Membership in and service on professional associations, learned societies, professional
review or advisory panels and accreditation bodies; presentation of lectures, papers,
concerts, or exhibits; participation in seminars and conferences; and reviewing or
editing scholarly publications and books are permitted.
3.
Ownership of or equity in a corporation used solely for one’s consulting activities.
4.
Requiring or recommending one’s own or one’s family member’s textbook or other
teaching aids, materials, software, equipment, or the like to be used in connection with
University instructional programs.
Examples of Potential Conflicts
CATEGORY II: Activities or relationships that may be allowable following disclosure and,
where necessary, the implementation of monitoring procedures or other forms of
management to ensure the integrity of research and other institutional activities.
CATEGORY III: Activities or relationships presenting such serious risks that they will be
presumed to be inappropriate unless it is determined that they can be managed in
accordance with this Policy. In such cases, a heavy burden will rest with the covered
individual to demonstrate to the University’s satisfaction the compatibility of such
relationships with University policy prior to going forward with the proposed activity.
Required and Suggested
Monitoring Activities
1. At the outset, monitors should meet with the affected covered
individual and his or her chair to review the circumstances of
the activities and relationships to be monitored, explain the
monitors’ function and authority, and address questions or
concerns. Monitors must be mindful that conflicts cannot be
managed successfully without cooperation and assistance from
the covered individual being monitored. Monitors should
approach their task in a spirit of collegiality, not adversity, and
such a spirit should inform interactions with the covered
individual to be monitored wherever possible.
Required and Suggested
Monitoring Activities
2. All monitors must meet annually with the covered individual
and regularly (at least once in approximately the middle of
each semester and as appropriate during the summer sessions)
with students and trainees (e.g., post-doctoral fellows,
residents, or in some cases junior faculty) of the covered
individual who has an activity that is being monitored. Because
students or trainees not directly involved in an approved COI
may still be affected by a covered individual’s commitments,
monitors should meet with every member of the covered
individual’s research group.
Required and Suggested
Monitoring Activities
3.
All students and trainees involved in research studies with a covered individual
who has an approved COI must be informed of the COI in writing either at the
beginning of the student’s or trainee’s involvement with the study or upon
approval of a COI and a management plan for the COI, whichever comes later.
The management plan will assign responsibility for sending written notice to the
students and trainees. Such written notice shall inform the students and
trainees: a) that the approved COI exists, and b) that their concerns, if any, can
be discussed with the Chair of the University Committee on Conflicts of
Interest, University’s Research Compliance Coordinator, Department Chair,
Dean, or, if applicable, the monitor or monitoring panel, as appropriate.
Monitors must work with the affected covered individual to introduce
procedures in the covered individual’s research group sufficient to assure that
such information is communicated on a timely basis to current students and
trainees, and to students and trainees who join the project later.
Required and Suggested
Monitoring Activities
4. Monitors should meet individually with student and trainee
members of the covered individual’s research group at least
once each year. The primary purpose of both group and
individual meetings is to ascertain whether students or trainees
perceive any untoward influence on their own or others’
research or education as a result of the conflict being
monitored. Students and trainees should be informed that
under University policy they may not be retaliated against for
good faith disclosures of such concerns.
Required and Suggested
Monitoring Activities
5. Monitors should review any publications made by the covered
individual or members of his or her research group to ensure
that significant financial interests have been reported in
conjunction with the publication and that the publication is
free of any inappropriate influence resulting from such
significant financial interests. Monitors should also look for the
absence of publications by the covered individual or members
of his or her research group, which may indicate inappropriate
withholding of research results.
Required and Suggested
Monitoring Activities
6. Monitors must keep minutes of their meetings and/or activities.
Where a Dean has delegated monitoring responsibilities,
monitors should report on their activities to the Dean or his
designee and to the University Committee and Dean’s
committee, where applicable, not less than annually. In order to
assist the Dean in ongoing evaluation of approved COIs, such
reports should be filed not later than 60 days before the next
due date for submission of Conflicts Evaluation Forms.
Conflict of Interest
Resources
• Conflict of Interest (NIH, OER)
– http://grants1.nih.gov/grants/policy/emprograms/
overview/ep-coi.html
• PHS Policy (42CFR50)
– http://www.access.gpo.gov/nara/cfr/waisidx_01/
42cfr50_01.html