Inventor's Guide To Technology Transfer

The Inventor’s Guide to Technology
Transfer outlines the essential

elements of technology transfer at
UNeMed—the publisher of this
guide and the technology and
commercialization office for the
University of Nebraska Medical
Center and the University of Nebraska
at Omaha.
This guide is organized to answer
the most common questions that
UNeMed typically fields from
Nebraska researchers, clinicians,
faculty, staff and students. This guide
provides a broad overview of the
technology transfer process and
services.
Useful and new information can
be found at www.unemed.com.
Specific questions should be directed
to UNeMed at 402-559-2468 or
unemed@unmc.edu.
This guide is based in part on a similar
guide produced by the University of
Michigan, and combined with the
expertise of UNeMed's experienced
staff.
Some definitions were provided
by various governmental sources
and Webster's New World College
Dictionary.
Credits: Graphic design by UNeMed. Photography by
UNeMed, unless noted; icons courtesy FontAwesome.
TABLE OF
CONTENTS
Tech Transfer Overview . . . . . . . . . . . . . . . . . . . . 1
Bayh-Dole Act . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Tech Transfer Process . . . . . . . . . . . . . . . . . . . . . 5
Innovation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Marketing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Commercialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Other Agreements . . . . . . . . . . . . . . . . . . . . . . 30
Other Considerations . . . . . . . . . . . . . . . . . . . . 33
Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Outside employment/VA appointments . . . . . . 34
International research . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Export controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
International travel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Startups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Appendix I: Policies . . . . . . . . . . . . . . . . . . . . . . 44
Board of Regents Bylaw 3.10 . . . . . . . . . . . . . . . . . . . . 44
Board of Regents Policy 4.4.1 . . . . . . . . . . . . . . . . . . . . 44
Board of Regents Policy 4.4.2 . . . . . . . . . . . . . . . . . . . . 53
UNMC Policy 7000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
UNMC Policy 7001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
UNMC Policy 8005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
UNMC Policy 8010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
UNMC Policy 8014 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Appendix II: Glossary . . . . . . . . . . . . . . . . . . . . 69

INVENTOR’S GUIDE TECHNOLOGY TRANSFER
TECHNOLOGY TRANSFER
OVERVIEW
About UNeMed
The University of Nebraska Board of Regents created
UNeMed in 1991. UNeMed is a not-for-profit entity
responsible for all technology transfer activities at
the University of Nebraska Medical Center and the
University of Nebraska at Omaha.
Mission
UNeMed primarily builds and develops partnerships UNeMed improves
with industrial leaders who can help push healthcare by fostering
innovations beyond the laboratory and into the innovation, advancing
marketplace. biomedical research and
engaging entrepreneurs
Advancing and commercializing University and industry to commer-
technology can take many forms, whether it’s cialize novel technologies.
creating a new startup company, licensing with a
massive multinational corporation or helping secure
sponsored research support. UNeMed uses every
tool available and continues to seek—or even create
new tools—to help innovations and discoveries
reach their highest potential.
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BACK TO TABLE OF CONTENTS 1
TECHNOLOGY TRANSFER OVERVIEW

In the most basic terms, technology Technology transfer for a reason:
transfer is the act of moving Positive impact on society
innovation and discoveries into the
Personal fulfillment
world for the benefit of all. At the
Recognition, financial rewards
University of Nebraska, technology
transfer refers to the efforts of creating Attract additional funding
partnerships as a way to help finance Contractual obligation
and support further development Create educational opportunities
of inventions, discoveries and Link students to future job
innovations at the University of opportunities
Nebraska.
Protect first, then publish

Of course inventors and researchers may still publish, but publishing
can affect an inventor's patent rights. It is therefore essential to
submit a "New Invention Notification" form well before any public
disclosure. There are significant differences between how early
publication affects a potential U.S. or foreign patent. A public
disclosure may significantly restrict or minimize the potential for
patent protection outside of the United States. It's best to inform
UNeMed of any previous or planned public presentations or
disclosures of the invention. The disclosure could be a lecture,
poster, abstract, website description, research proposal submission,
thesis, grant submission, publication, or something similar. UNeMed
has a few ways to quickly and easily protect an idea before a public
disclosure can spoil an invention's chance at further development.
What is the Bayh-Dole Act?

The Bayh-Dole Act of 1980 provides ownership rights to
universities and other non-profit institutions for discoveries
resulting from federally funded research, as long as certain
obligations are met. Obligations include:
efforts to protect and commercialize the discoveries
submitting progress reports to the funding agency
giving preference to small businesses that
demonstrate sufficient capability
sharing any resulting revenues with the inventors
The Bayh-Dole Act is credited with stimulating technology
transfer activities and generating increased research,
commercialization, educational opportunities, and economic
development in the United States.
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Tech transfer timeline with any degree of confidence
The process of protecting a is UNeMed will evaluate each
technology—and finding the invention and recommend
right commerical partner—may the next steps within 30 days.
take months, even years. The Following that, there might
amount of time will depend on be a need for further research,
the unique circumstances of the which may take months, or
invention itself. Critical factors even years, to complete. Some
include the development stage inventions can be immediately
of the technology; the market; marketed to commercial entities
competing technologies; the or private equity groups, but
amount of work needed to even then, that process could
bring a new concept to market- be as quick as a single email
ready status; and the available exchange or it could take
resources and willingness of the years of back-and-forth with
licensees and inventors. interested parties. Even when a
The actual timing of the license agreement is in place, the
process will vary because, by commercialization process could
definition, no two inventions still take years to complete.
are alike. All that can be said Often, additional development is
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required to refine an invention
into a market-ready product.
Commercialization is most
often a slow, methodical process How inventors help UNeMed
that moves at seemingly glacial When something new is
speeds. It will require patience created, discovered or
and perseverance. conceptualized, call UNeMed
at 402-559-2468.
Submit a completed and signed
How UNeMed helps inventors "New Invention Notification"
The best time to contact form before publicly disclosing
UNeMed is during the earliest your invention or submitting
stages of innovation. That a manuscript for review and
applies to all potential inventors, publication.
whether it’s a laboratory To avoid losing patent rights,
researcher planning experiments and possibly harming the
or a clinician sketching a opportunity to market
concept or new device on the an invention, contact
back of a napkin. Bringing UNeMed before any form
UNeMed into the process early of public disclosure such as
presentations, publishing
gives inventors the fullest range
papers, grant submissions,
of options for the innovation, writing abstracts, or presenting
and the best possible steps for posters, to name a few.
moving forward. UNeMed Fortunately, simple steps can
staff are trained experts, ready quickly protect an invention
to help with questions about before publishing or presenting.
marketability, commercial On the new invention
partners, intellectual property, notification form, include
patents, new startups, companies and contacts
institutional policies and that might be interested in
procedures and much more. licensing. Such information
When an inventor works with will help UNeMed develop
UNeMed, they don't just get new leads, and perhaps create
a licensing manager: They get relationships that will prove
fruitful for years to come.
all of UNeMed, and the wide
range of profound expertise and Respond to requests from
experience that comes with it. UNeMed and outside patent
counsel.
Keep UNeMed informed of
upcoming publications and
interactions with companies.
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TECHNOLOGY TRANSFER
PROCESS
INNOVATION
INNOVATION:
An invention is any new and
useful process, machine,
composition of matter, or
any improvement of those COMMERCIALIZATION
DISCLOSURE
things. Contact UNeMed
in the earliest stages of
development for guidance
on all phases of the
process.
DISCLOSURE: Tech Transfer
The process formally
LICENSING
Process
begins with the
submission of a written EVALUATION
New Invention Notification
form, or NIN for short.
The New Invention
Notification paperwork is
strictly confidential, and
should fully document the
MARKETING
invention so that all options PROTECTION
for commercialization can be
evaluated.
EVALUATION:
UNeMed reviews the
technology as disclosed in the MARKETING:
New Invention Notification, UNeMed staff identify potential commercial partners who
and searches publication and have the necessary expertise, resources and business networks
patent databases for similar to bring the technology to market. This may involve an
innovations. UNeMed also existing company or forming a startup. UNeMed works with
analyzes potential markets and potential licensees to fully commercialize the technology.
competitive technologies to
determine commercialization LICENSING:
possibilities. A license agreement is a contract in which UNeMed grants
limited rights to a technology without giving up ownership.
PROTECTION: Most often those rights allow a licensee to use their resources
When appropriate, UNeMed to further develop a technology. An "option agreement"
will protect inventions by is sometimes used to enable a third party to evaluate a
filing applications for United technology for a limited time before committing to a licensing
States and foreign patents. contract.
Other protection methods
include copyright, trademark, COMMERCIALIZATION:
trade secrets and contractual The licensee advances a technology, and makes it publicly
use restrictions. Once basic available on the open market. This final step may require
protections are in place, regulatory approval, sales and marketing support, training,
UNeMed can begin marketing product testing, and other activities appropriate to the
the technology to potential technology and its market. A portion of any revenue is then
commercial partners. distributed to inventors in accordance to institutional policy.
The remainder of any revenue feeds additional research and
more innovation.
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TECHNOLOGY TRANSFER PROCESS

INNOVATION
What is an invention?
An invention is any new and useful process, machine,
composition of matter, or any improvement of those
things. Typical inventions include therapeutics,
diagnostics, drug delivery platforms, medical devices,
research tools, educational materials, apps and software.
Inventions also include new uses of existing products
and devices.
Inventions are important, but not everything important
is an invention. What sets apart an invention from an
idea is that an invention:
1. Is different from what's already out there
2. Has product value
3. Has a good intellectual property position
4. Has good commercial potential
When research becomes an invention

One good indicator that research qualifies as an
invention is when a finding or development appears
to solve a significant problem. Or, perhaps the
research reveals something totally new and not yet
published in any literature. When in doubt, contact
UNeMed to discuss the invention and strategies for
commercialization.
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TECHNOLOGY TRANSFER PROCESS: INNOVATION
Research tools Student inventors

Any new research tool that could The University of Nebraska
benefit others is definitely worth promotes student
pursuing as a new invention. entrepreneurism, and students
Typically, research tools are can be named as inventors under
materials such as antibodies, the Board of Regents’ policies.
vectors, plasmids, cell lines, The Board of Regents’ policies
mice, and other biological indicate that student inventors
materials used in the research are subject to the same rules
process. Most research tools do and receive the same benefits as
not necessarily need patents to University employee inventors.
be licensed to commercial third The University does draw a
parties and generate revenue. distinction between graduate
UNeMed commonly works with and undergraduate students,
inventors to develop appropriate and under what function the
protection, licensing, and students are performing the
distribution strategies for work. UNeMed would be
research tools that have happy to help student inventors
commercial or scientific value. navigate these gray areas.
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DISCLOSURE
New Invention Notifications

A New Invention Notification, or NIN, is a
written description of an invention. NINs create a
written, dated record of an invention, and provides
information from which the patent and commercial
potential can be evaluated. NINs also ensure
compliance with U.S. federal laws, University policy
and the policies of several research-funding agencies.
The New Invention Notification should list all
collaborating sources of support, and include
the information necessary to pursue protection,
marketing and commercialization activities.
UNeMed uses the new invention disclosure to
generate a non-confidential description to assist
marketing efforts. More detailed exchanges of
information are possible once potential partners have
been identified, and basic protections are in place.
Submitting a new invention

Download the New Invention Notification form and
simple instructions at https://www.unemed.com/
services/inventions. Submit completed notification of
new invention forms directly to UNeMed.
Contact UNeMed with any questions.
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TECHNOLOGY TRANSFER PROCESS: DISCLOSURE

When to submit a NIN
Submit ideas to UNeMed well Why? Three good reasons
before publicly disclosing the There are at least three good
discovery or idea through reasons to submit a new
publications, poster sessions, invention notification.
conferences, press releases, First, it is likely a condition
grant applications, dissertation of University employment to
defenses, seminars or other report inventions and new
communications. We cannot discoveries that are related to
stress enough that inventions the work or that were developed
must be safely and confidentially with University or hospital
disclosed to UNeMed before any resources.
public disclosure.
Second, reporting new
Be sure to inform UNeMed inventions is a requirement
of any previous or planned for federally funded research.
presentations, lectures, posters, Failure to report a new invention
abstracts, website descriptions, puts future federal funding at
research proposals, theses, serious risk.
publications, or other public
disclosures that mention or Finally, disclosure starts a
in some way describe the process that brings to bear
invention. UNeMed's full toolkit of options
and resources, giving the
A public disclosure results in innovation its best chance to
the loss of foreign patent rights, reach the market where it can
and leaves one year (from the actually help people.
date of the public disclosure) to
secure U.S. patent rights. Loss
of foreign patent rights can Listing co-inventors
decrease the value and overall from other institutions
appeal of a technology. All contributors to the ideas
leading to an invention should
Working with UNeMed—early be mentioned in the disclosure,
and often—is the easiest way to even if they are not University of
protect the rights of both the Nebraska employees. UNeMed,
inventor AND the University. along with legal counsel, will
If a researcher believes their determine the rights of such
work may contain patentable persons and institutions.
subject-matter, they should It is prudent to discuss
contact UNeMed. Inventors with UNeMed all working
should submit a new invention relationships (preferably before
notification as soon as they have they begin) to understand the
something unique. implications for any subsequent
inventions.
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EVALUATION
After submitting a NIN...

A member of UNeMed's licensing team
examines each submission to review an
invention for its novelty, protectability,
marketability, market size and growth
potential, resources required for further
development, and potential competition
from other products or technologies. This
assessment may also examine whether the
technology has potential as the foundation of
a new startup company.
UNeMed does not evaluate the scientific
merits or rigor of an invention. However, in
the course of the evaluation process, UNeMed
staff may learn things that could help inform
researchers and inventors as they continue
their work.
Once an invention's licensing manager
completes their initial review of the invention,
it is presented to UNeMed's Science and
Technology Advisory Committee. The
outcome depends on the marketability and
patentability of the invention.
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TECHNOLOGY TRANSFER PROCESS: EVALUATION

UNeMed may choose to immediately protect the invention, or
request additional research to further strengthen an invention. Or,
UNeMed may find that someone else has already patented the idea
or discovery. In that case, UNeMed might be able to suggest a new
line of approach for a different or related project where an inventor
can break new ground.
More specifically, possible outcomes of the evaluation process
usually include one of the following:
More research needed: When an invention needs

further refining or development before it can be
protected or marketed.
Protect and market: When an invention appears
to have a solid market, a clear patent position and
supporting data, it is ready for an active marketing
campaign seeking commercial partners and
investment,
Close: For any number of reasons, UNeMed may
recommend closing or abandoning an invention.
Common reasons for closing an invention include
lack of patentability and little or no market
potential. Recommendations like this can be
disappointing, or even painful. In our experience
this kind of negative feedback more often
provides an inventor or researcher a new path of
discovery that can lead to more successful routes
of innovation with even more potential to help
people.
The licensing manager assigned to the technology will
meet with the inventor to discuss the evaluation and
the committee's recommendation, and determine
how to best most forward.
Unprotected inventions
If UNeMed decides not to pursue patent protection or chooses
not to actively market an invention, the inventors may request a
license from UNeMed to protect and commercialize the invention
themselves. Such a license would be limited to the current invention
and not future improvements.
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PROTECTION
Intellectual property
Once a decision is made to move forward
with an invention, UNeMed may seek
intellectual property protection, which might
include patents, trademarks or copyrights, to
name a few.
UNeMed most often protects University
inventions with patents for things like
devices, compounds or drug formulations.
The life-span of a patent is about 20 years,
and allows UNeMed to seek industrial
partners who can fund the development of
the invention into a product.
Expressions of creative works are protected
by copyrights. Common examples of
copyrights include books, music, movies,
photos and artworks. Most copyrighted
works at UNeMed are things like software
applications or educational materials.
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TECHNOLOGY TRANSFER PROCESS: PROTECTION

Ownership Regents Policy 4.4.2 (See page
Ownership depends upon 53). Therefore, researchers
the employment status of the must pay special attention when
inventors and their use of signing consulting agreements
facilities. As a general rule, that they do not assign rights to
the Board of Regents owns any inventions that Policy 4.4.2
inventions made by University covers. If the innovation was
of Nebraska employees who performed outside the scope
are acting within the scope of employment duties and not
of their employment or using using University resources, then
University resources. In some the University does not own
cases, the terms of a sponsored the invention and it could be
research agreement or material assigned.
transfer agreement may impact A researcher engaging a
ownership. When in doubt, consulting opportunity is acting
it is best to call UNeMed for independent of the University.
guidance. Therefore, UNeMed and
University attorneys are unable
Inventions resulting to offer legal advice to the
from consulting work researcher. However, they could
The University encourages review a consulting agreement
researchers to engage in external and warn if any provisions
professional activities in order appear to potentially impinge
to broaden experience, increase the rights of the University.
exposure to new research, and Plus, they have seen many
develop strategic relationships. agreements and can generally
Policies establish the parameters educate a researcher on common
and procedures for engaging in contract issues.
such consulting work, and for
new inventions a researcher’s Authors vs. inventors
obligations to the University There is a profound difference
must be the superior right in between the legal definition of
any consulting agreement. As an inventor and who may be
an employee of the University, listed as an author on something
the researcher has a first like an academic paper. Under
obligation to the University to U.S. law, an inventor is a
assign rights to any patentable person who takes part in the
inventions that result from the conception of the ideas set forth
performance of duties within the in the claims section of a patent
scope of University employment application.
or resulting from the use of To be listed as an inventor on a
University resources. Such patent, the individual must have
inventions “shall be solely owned contributed something in the
by the University” per Board of way of an idea, concept or feature
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on the invention. Even if a friend, a legal issue and may require an
colleague or associate contributed intricate legal determination by the
large amounts of time and energy in patent attorney who prosecutes the
support of the work, if they didn’t application.
conceive of the idea or contribute No detail is too small when
some small intellectual part of it, then determining who should—or should
they cannot be listed as an inventor. not—be listed among a patent’s
No matter the size of the intellectual inventors. An error at this stage can
contribution, all contributions are later invalidate an issued patent.
viewed as equal in the eyes of the UNeMed exerts a lot of time and
U.S. Patent and Trademark Office. energy to ensure this doesn't
There is no special importance happen, but if it’s determined that an
attached to who is listed first or last. inventor should be added to a non-
In contrast, authorship carries a provisional patent application, that
much lower standard, and a co- person may be added at the time the
author credit might be afforded provisional application is converted
anyone who contributed in any into a non-provisional application.
capacity to a paper's creation. In If an inventor is identified after filing
a similar fashion, an employer or the non-provisional application,
person who only furnishes money we can petition a change be made
to build or practice an invention in inventorship but the process is
is not an inventor. Inventorship is costly.
14 UNEMED.COM

Patents want to demystify the unknown.
A patent gives an invention A patent, it would seem, flies
its best chance to reach the in the face of those noble aims.
most people. That might sound Biomedical discovery and
counterintuitive because a patent innovations should be shared
is, in essence, a legal monopoly with the world, should they not?
to restrict others. A United Yes, in a perfect world.
States patent gives the holder
the right to exclude others But in our less-than-perfect
from making, using, selling, world, it can take more than
offering to sell, and importing a billion dollars to develop
the patented invention. A patent a new discovery into a new
does not necessarily provide the treatment. That development
holder any affirmative right to only happens if the technology
practice an invention. is properly protected, giving the
developer the opportunity to
The founders built the patent at least recover such significant
system into the U.S. Constitution expenses.
for good reasons, not the least
of which is allowing an inventor What that usually means for
enough opportunity to recover UNeMed and its inventors is
costs, and perhaps even profit finding an industrial partner
from the fruits of their labor and who can pay for the needed
ingenuity. After about 20 years, development in exchange
a patent’s legal protection goes for certain rights to use the
away. The invention—requisitely patented invention. Without a
described in mundane detail patent, it’s exceedingly rare to
in the publicly accessible see a novel technology go much
patent—becomes the property further than the pages of an
of anyone who has the means or academic journal. The patent,
inclination to build it. however, encourages industrial
partnerships that finance
Even if imperfect, it’s a clever additional development and
system that all at once protects, discovery.
encourages and disseminates
innovation.
Patentable subject matter
The notion of ownership in At the earliest stages, UNeMed
academic biomedical research is must determine if a new
a thorny one. Presumably, most technology meets the United
researchers pursue future cures, States Patent and Trademark
treatments and medical devices Office's criteria for a patent.
for nothing less than noble It must also be noted that
purposes. They want to help patentability has nothing to
those who need it most. They do with the scientific value of
want to cure the incurable. They any invention. An invention
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may still represent a significant example, an inventor may be
contribution to science, even unable to patent a piece of
if the invention does not meet genetic code, but an inventor
established patent criteria. can patent a way to use that strip
Patentable subject matter of DNA for some previously
includes processes, machines, unknown purpose. A variation
compositions of matter, articles, of a naturally occurring
some computer programs, substance may be patentable,
and methods. Methods can however, if an inventor can
include methods for making demonstrate substantial and
compositions, methods for "non-obvious" modifications
making articles, and even that offer advantages over the
methods for performing original substance.
business. Determining the criteria
Naturally occurring for patentability can be
substances—such as DNA accomplished by asking three
sequences—are not patentable, questions:
unless some underlying utility 1. Is it new?
has also been discovered. For 2. Is it useful?
3. Is it non-obvious?
A new, or novel, invention
must be different in some way
from all other ideas that have
already been publicly disclosed
in any form. The invention must
perform a useful function and
somehow benefit society. And
the invention can't be merely
an obvious improvement to an
existing technology in the eyes of
those knowledgeable in the area.
Though these may seem like
simple questions, they are
serious and require extensive
research. A lack of thoroughness
at this point could amount to
a costly mistake. If the USPTO
rejects a patent application
because it did not meet one or
more of those three criteria,
UNeMed will have squandered
somewhere between $12,000
and $22,000.
16 UNEMED.COM

Publications greatly impact the to seven years. After a patent
novelty and non-obviousness application has been filed, it
factors of patentability. It might be 2-4 years before the
may be impossible to patent USPTO reviews the application.
an invention if different It will take another 1-3 years of
publications so much as mention back-and-forth with the USPTO
each of the separate elements of before a patent will be issued.
an invention. It doesn't matter Once issued, a U.S. utility patent
if the mention appeared in expires 20 years after its earliest,
the most widely read journals non-provisional priority date,
or the most obscure of niche but there are extensions available
publications. to offset any USPTO delays.
Even an earlier public disclosure However, the patent holder must
from the inventor can prohibit pay maintenance fees, 3.5, 7.5
a patent. U.S. law allows for and 11.5 years after the patent
patenting an invention up to issues to keep the patent alive for
one year after disclosure, but its full term.
nearly all foreign countries Here is a more detailed,
prohibit patenting once a although dramatically simplified
public disclosure has occurred. version of the process:
Losing the ability to protect an
invention overseas can make First, patent attorneys—usually
an invention less attractive to with advanced degrees and
potential industrial partners. expertise in at least one scientific
field—are best suited to draft
most patent applications.
Patent applications Inventors are asked to review
UNeMed uses expert patent patent applications before
attorneys in diverse technology they are filed. At the time an
areas to help draft and prosecute application is filed, inventors
patent applications. Inventors sign documents that officially
work with the patent attorneys declare themselves inventors and
to draft patent applications assigns the application to the
and respond to U.S. and University.
international patent offices.
Two or three years later, the
USPTO will accept or reject
Patent process the application in writing.
The process for securing a The patent office usually
United States patent is long rejects applications for two
and winding, and not without common reasons: Either certain
its fair share of nuance and formalities need to be cleared
complications. Start to finish, it up, or "prior art" invalidates
can take anywhere from three the listed claims. Prior art
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could include previous patent fees are paid, a patent is
applications, older patents, or enforceable for 20 years from its
any other published material earliest filing date.
that has been publicly disclosed.
The communication sent by the Provisional patent applications
patent office is referred to as an In certain circumstances, U.S.
"office action." If the application provisional patent applications
is rejected, the patent attorney can preserve patent rights while
must file a written response, temporarily reducing costs, and
usually within three to six perhaps provide extra time to
months. The attorney may prepare a regular application.
amend the claims or dispute Provisional patent applications
the patent office’s position. are less costly, but they only have
This procedure is referred to a one-year lifespan and are never
as "patent prosecution." Often, prosecuted or issued as full
it will take at least two office patents. Provisional applications
actions before the application is do not need to include claims
resolved. and are not examined during the
During this process, input year in which it is pending.
from the inventor is crucial to They essentially act as a
confirm technical aspects of the protective placeholder while
invention. Patent prosecution notifying the patent office of
ends when the patent office an invention. The provisional
notifies UNeMed that the application also allows inventors
application is allowable or when more time to gather important
it becomes clear that the patent data, if needed, and build a
office will not allow any subject more robust patent application.
matter. The protection a provisional
When the claims are allowed, provides also allows UNeMed to
the patent can be issued. But, open discussions with potential
it is also possible to reject the partners without risking an
patent office's allowed claims, invention's patentability.
and restart the entire process. These early discussions play
a crucial role in gaining a
Patent timeline better understanding on the
Currently, the average U.S. utility marketability and patentability
patent application receives its of a new invention.
first office action two or three A regular U.S. application—and
years after filing, and then related foreign applications—
undergoes patent prosecution must be filed within one year
for another two to three years. of the provisional application
Once a patent has issued, and all to receive its early filing date.
USPTO mandated maintenance However, an applicant only
18 UNEMED.COM
receives the benefit of the would have to secure a patent in

earlier filing date for material every country in the world.
that is adequately described An international agreement
and enabled in the provisional known as the Patent
application. As a result, the Cooperation Treaty, or
patent attorney will need the PCT, provides a streamlined
inventor's assistance when filing procedure for most
an application is filed as a industrialized nations. For U.S.
provisional. applicants, a PCT application is
generally filed one year after the
Foreign patents corresponding U.S. application
Patents are territorial, meaning has been submitted. The PCT
a U.S. patent only provides application must be filed in the
rights in the U.S. and a Chinese patent office of any country in
patent only provides rights in which the applicant wishes to
China. Foreign patent protection seek patent protection, and it
is subject to the laws of each must be filed within 30 months
individual country, although the of the earliest claimed filing date.
process works much the same as The biggest difference in
it does in the United States. For foreign countries is an inventor
world-wide patent coverage, one immediately loses patent rights
UNEMED.COM

when they publicly disclose an published and unpublished
invention anywhere in the world works. The Copyright Act
before filing a patent application. generally gives the owner of a
In stark contrast, the United copyright the exclusive right to
States grants a one year grace conduct and authorize various
period for inventors who acts, including reproduction,
publicly disclose their inventions public performance, and making
before filing for a U.S. patent. derivative works. Copyright
protection is automatically
The cost of patents secured when a work is fixed
Filing a regular U.S. patent into a tangible medium such
application may cost between as a book, software code,
$8,000 and $18,000, plus an video, etc. In some instances,
additional $12,000 to $20,000 in UNeMed registers copyrights,
patent prosecution. Filing and but generally not until a
obtaining issued patents in other commercial product is ready for
countries could cost $25,000 or manufacture.
more per country. Also, periodic
maintenance fees are often Derivative works
required to keep the patent alive. A derivative work is a work
based upon one or more
Copyrights preexisting works, such
Copyright is a form of as a translation, musical
protection provided to the arrangement, dramatization,
creators of “original works fictionalization, motion picture
of authorship.” This includes version, sound recording, art
literary, dramatic, musical, reproduction, abridgement,
artistic, and certain other condensation, or any other form
intellectual works, as well in which a work may be recast,
as computer software. This transformed or adapted. A work
protection is available to both consisting of editorial revisions,
Proper copyright notices

Although copyrightable works do not require a copyright notice, we
recommend that you use one. Use the following notices for works
owned by...
UNMC:
© 20XX University of Nebraska Medical Center. All rights reserved.
UNO:
© 20XX University of Nebraska at Omaha. All rights reserved.
Nebraska Medicine:
© 20XX Nebraska Medicine. All rights reserved.
20 UNEMED.COM

annotations, elaborations, or the source of the service.
other modifications, which, It is not necessary to register a
as a whole, represent an trademark or service mark with
original work of authorship, is the United States Patent and
a derivative work. The owner Trademark Office. Trademarks
of a copyright generally has generally become protected
the exclusive right to create as soon as they are adopted
derivative works. by an organization and used
in commerce, even before
Trademarks and service marks registration. With a federal
A trademark includes any trademark registration, the
work, name, symbol, device, registrant is presumed to be
or combination that is used entitled to use the trademark
in commerce to identify and throughout the United States for
distinguish the goods of one the goods or services for which
manufacturer or seller from those the trademark is registered. State
manufactured or sold by others. trademark registration is also
In short, a trademark is a brand available in Nebraska.
name.
A service mark is any work, Trade secrets
name, symbol, device, or Trade secrets are confidential
combination that is used, or strategies or information that
intended to be used, in commerce give their users a competitive
to identify and distinguish the advantage. The best examples
services of one provider from of trade secrets are the recipes
those of others, and to indicate for Coca-Cola and Kentucky
An example of trade
secret protection for
a UNMC innovation
is NeuroFreeze, a
proprietary blend
of four components
that enable
researchers to freeze
brain cells with
a remarkable 90
percent viability.
UNEMED.COM
Fried Chicken. Trade secrets high cost of patent fees into

have limited legal protection. license agreements as a part of
The best protection for a trade the investment contribution
secret is limiting the number corporate partners make in
of people who can access the developing a technology.
information while installing The decision on which
security measures and using inventions receive intellectual
confidentiality agreements. property protection is not
taken lightly. Significant factors
What UNeMed include the recommendation
protects, what it doesn't from UNeMed's Science
Inventions at UNeMed are and Technology Advisory
almost always early-stage Committee, and feedback from
innovations, the development industrial and commercial
of which require significant contacts.
investments in time and money. Often UNeMed accepts the risk
The only way a commercial of filing a patent application
partner can recover that before a licensee has been
investment is with clear identified. But eventually
intellectual property protection UNeMed must decline
in place. An invention further patent prosecution if a
that cannot be protected, commercial partner cannot be
often cannot be marketed found after a reasonable amount
or developed successfully. of time.
UNeMed prefers to include the
University of Nebraska policy

The Board of Regents’ Bylaw 3.10
and Policies 4.4.1 and 4.4.2 address
the University of Nebraska’s policies
regarding intellectual property
ownership and technology transfer.
These regulations are available in the
appendix on page 44 or online at
http://nebraska.edu/regents/bylaws-
policies-and-rules.
22 UNEMED.COM

MARKETING
Marketing an invention
UNeMed employs several strategies to
identify potential commercial partners and
licensees. Sometimes existing relationships
of the inventors, UNeMed staff, and other
researchers are useful in marketing an
invention. UNeMed conducts extensive
market research to identify prospective
licensees. UNeMed also examines
complementary technologies and agreements
for more leads. UNeMed also uses its website
to promote inventions, host conferences and
industry events and makes direct contacts.
Faculty publications and presentations, news
reports, social media campaigns are often
excellent marketing tools as well.
How inventors can help
Once patent protection has been sought,
inventors can publish as many papers and
give as many presentations describing the
invention as possible. Inventors are also
encouraged to talk with their licensing
manager about the invention and any
consulting relationships they might have.
These relationships are often helpful
in identifying potential licensees and
UNEMED.COM
TECHNOLOGY TRANSFER PROCESS: MARKETING
technology champions within

companies. The most successful Sharing data
technology transfer results are It's common for inventors
obtained when the inventor and to express discomfort about
the licensing manager work sharing the technical details of a
together to market and sell a new invention with third parties.
technology. It is an understandable concern
Finally, and perhaps most that a commercial enterprise
importantly, inventors give might steal a proposed invention
themselves the best chance rather than enter a license
just by being accessible and agreement.
responsive. The truth: It is exceedingly
rare for a potential licensee to
Finding a licensee simply steal an invention. But
It can take months and it's not unheard of, and that's
sometimes years of marketing why UNeMed takes every
to locate a potential licensee. reasonable precaution to protect
Success depends on the inventions before sharing
attractiveness of the invention, details with anyone. The most
its stage of development, common precautionary step
competing technologies, and UNeMed takes is some form of
the size and intensity of the intellectual property protection,
market. Most inventions tend such as a patent applications
to be in the early stages of the and confidential disclosure
development cycle and thus agreements.
require substantial investment, The technology manager will
making it more difficult to prepare non-confidential
attract a licensee. material that will be distributed
to targeted industry personnel.
Selecting a licensee Technical and confidential
A licensee is selected on their details of the invention will
ability to commercialize the only be disclosed to a potential
technology for the benefit of partner under a confidential
the general public. Sometimes disclosure agreement. Also
an established company known as a non-disclosure
with experience in similar agreement (see page 31), such
technologies and markets is arrangements allow UNeMed
the best choice. In other cases, to seek potential development
forming a startup company may partners while protecting an
be the better option. invention's ownership.
24 UNEMED.COM

LICENSING
License agreements
If a company remains interested in developing
and commercializing an invention, the
technology's licensing manager will negotiate
terms. A licensing agreement is a contract
obligating the licensee to help develop the
technology and ultimately bring it to market.
License agreements describe the rights
and responsibilities related to the use and
exploitation of an inventor's intellectual
property. UNeMed's license agreements usually
stipulate that the licensee should diligently
seek to bring the intellectual property into
commercial use for the public good and provide
a reasonable return.
Typically, UNeMed also requires that the
licensee make financial payments, and meet
certain performance goals for developing
an invention. The licensee is most often an
established company, but it’s not uncommon to
license a technology to a new startup, which are
sometimes founded by the inventors themselves.
Any revenue from licensing agreements are
shared with the inventors and other stakeholders,
in accordance with institutional policy.
UNEMED.COM
TECHNOLOGY TRANSFER PROCESS: LICENSING

Option license information, review the Board
A company might initially of Regents policy 4.4.2 in the
prefer a lower risk, option appendix on page 53 or online
agreement. Option agreements at http://nebraska.edu/regents/
allow commerical partners an bylaws-policies-and-rules.
extra amount of time to further UNMC Policy 7001 for Royalty
evaluate the technology for a and Equity Distribution can also
limited period of exclusivity. The be found in the appendix on
terms of an option agreement page 56 or online at https://
are most commonly about six wiki.unmc.edu/index.php/
months long. Royalty/Equity_Distribution.
Specific policies for the
Multiple licensees University of Nebraska at
An invention can be licensed Omaha were not available at
to multiple licensees, either time of publication.
non-exclusively to several
companies; or exclusively to Potential financial rewards
several companies, each for a aside, most inventors enjoy the
unique field-of-use (application) satisfaction of knowing their
or geography. inventions are being developed
for the benefit of the general
public. New and enhanced
Inventors benefit from licenses relationships with businesses
For UNMC inventors, one are another outcome that can
third of the net proceeds augment one’s professional
from a license are divided life. In some cases, additional
among inventors. For more sponsored research may result.
One example of a licensed

UNMC invention is the
LeVeen Electrode Needle.
Initially licensed in 1995 to
RadioTherapeutics for further
development, the device
used radio frequencies to
destroy tumors with greater
precision. RadioTherapeutics
was eventually acquired by
Boston Scientific, and the
LeVeen Electrode Needle
went on to become the most
widely used tumor ablation
tool in the United States.
26 UNEMED.COM
TECHNOLOGY TRANSFER PROCESS: LICENSING

Inventor-licensee relationships
In the early stages of
development, many licensees
require an inventor's active
assistance to facilitate
commercialization efforts.
The type of arrangement
can vary from infrequent,
informal contacts to a more
formal consulting relationship.
Working with a new startup
can require substantially
more time, depending on the
inventor's role.
UNeMed license agreements generally include:

Development plan—Milestones for commercialization, in
accordance with a developmental and commercialization plan,
are required at the time of license execution. Milestones may
include regulatory filings, initiation and completion of clinical
studies, or achievement of other research and development
goals. The licensee must also submit annual development
reports throughout the term of the license agreement.
Development reports ensure that the licensee is actively
developing the technology, which is also a requirement for
licensing federally-funded research.
Financial obligations—May include up-front license fees, equity (in
the case of a startup), milestone payments, royalty payments,
minimum royalties, and maintenance fees. These fees will be
determined based on the licensed technology. The licensee will
be responsible for paying patent expenses, incurred and future.
Earned royalties—Licensee pays a percentage of net sales to
UNeMed.
Milestone fees—In addition to royalties, milestone payments may be
required as the technology is successfully developed.
Minimum royalty—In royalty-bearing licenses, UNeMed might
require payment of a certain minimum dollar amount, which
generally reflects the minimum amount of expected sales.
UNEMED.COM

COMMERCIALIZATION
The commercialization process

Most licensees continue developing an
invention after signing a license to enhance
the technology, reduce risk, improve
reliability, meet regulatory requirements,
and satisfy the market. This can involve
additional testing, prototyping, and further
development to improve performance and
other characteristics.
Inventor's role
The inventor's role varies, depending on
their interest and involvement. The role also
depends on the licensee's interest level in
involving the inventor, and any contractual
obligations related to the license or any
personal agreements.
Commercialization revenues
Licensing fees can be modest or can reach
millions of dollars. Royalties on the eventual
sales of the licensed products can generate
revenues, although this can take years.
Equity, if included in a license, can yield
returns when a successful equity liquidation
event occurs, such as a public equity offering
28 UNEMED.COM
TECHNOLOGY TRANSFER PROCESS: COMMERCIALIZATION

or selling the company. Most UNeMed for the administration of
licenses do not yield substantial technology transfer. The remaining
revenues. A recent study of licenses 90 percent is distributed according
at U.S. universities demonstrated to UNMC’s Royalty Distribution
that only 1 percent of all licenses Policy which requires that one-third
yield more than $1 million in total be distributed among the inventors
revenue. and the remaining two-thirds are
Commercialization can fail at any used to promote innovation on
time, for any reason. campus.
Licenses typically include Specific distribution arrangements
performance milestones that, if for UNO were not available at time
unmet, can result in the termination of publication.
of the license. This termination
allows for subsequent licensing to Distributions for multiple inventors
other businesses. After a license agreement is
Failure does not necessarily negate signed, inventors enter into a
the value of an invention, and might royalty sharing agreement, and
even help increase the odds of later file the original agreement with
success. UNeMed. Once UNeMed receives
net proceeds, UNeMed follows
the royalty sharing agreement to
Distributing revenue distribute the money. If UNeMed
UNeMed is responsible for does not receive a royalty sharing
managing the expenses and agreement from the inventors
revenues associated with technology before net proceeds are received,
agreements. then UNeMed distributes them
All revenue received from a licensed equally among inventors.
technology follows parameters
set by Board of Regents policy Tax implications
4.4.2. First, all costs from patent License revenues are typically taxed
expenditures are reimbursed prior as income. Inventors should consult
to distribution. Then, 10 percent a tax adviser for specific guidance.
of the revenue is returned to
UNEMED.COM
OTHER
AGREEMENTS
Sponsored Research Agreements: Partners help development

Sponsored research agreements describe the terms under which
sponsors—such as a pharmaceutical firm or a medical device
manufacturer—provide support for additional research at the
University. Often these type of agreements are in support of an
early stage technology that needs additional testing, or to develop a
working prototype of a medical device.
The University generally retains ownership of patent rights and other
intellectual property resulting from sponsored research. However,
the sponsor may have rights to license new intellectual property
developed as a result of the sponsored research. Often, sponsored
research contracts allow the sponsor a limited time to negotiate a
license for any intellectual property that results from the research.
Even so, the sponsor generally will not have contractual rights to
discoveries that are clearly outside of the scope of the research.
Therefore, it is important to define the scope of work within a
research agreement.
Material Transfer Agreements: Sharing intellectual property & tools

These agreements describe the terms under which faculty, students
and staff at the University of Nebraska may share materials with
outside entities, such as research collaborators. Intellectual property
rights can be endangered if materials are used without a proper
agreement.
30 UNEMED.COM
OTHER AGREEMENTS
It is important to document carefully the date and conditions of use.
These details are necessary to determine if the use influenced the
ownership of any subsequent research or innovations. UNeMed can
help draft a material transfer agreement to obtain materials from
outside collaborators, or to send materials to an external collaborator.
Material transfer agreements attach certain terms to the use of
tangible research materials allowing other researchers to use them
while protecting rights associated with the materials and retaining the
ability to commercialize.
A simple university-university MTA can generally be handled in a
day or two. More complex MTAs—which might deal with foreign
companies or proprietary materials from industry—can take longer to
negotiate.
At UNMC, tangible materials can include molecular biology reagents,
cell lines, recombinant mice, devices or even software.
Those interested in transferring materials should contact UNeMed's
Contracts Manager at unemed@unmc.edu or (402) 559-2468.
To expedite the process you will need:
1. Information related to the source of funding.
2. Original source of the materials, or any portion of the material.
3. A description of the intended research making use of the materials.
4. Information on the receiver or sender of the materials.
Confidential Disclosure Agreements: An added layer of protection

Confidential disclosure agreements or nondisclosure agreements
further enable discussion of business development opportunities or
early-stage scientific collaboration. For protection of patent rights,
CDAs are critical because premature public disclosure can limit or
even preclude patent rights.
CDAs are used to protect the confidentiality of an invention during
evaluation by a potential licensee. UNeMed uses these type of
agreements to protect proprietary information shared with someone
UNEMED.COM
OTHER AGREEMENTS
outside of the University of Nebraska system. These type of
agreements also protect proprietary information of third parties
when, for example, University researchers perform consulting
work or sponsored research with a commercial partner or other
collaborative entity.
Inter-Institutional Agreements: Set ground rules for collaborations

Inter-institutional agreements describe the terms under which
two or more institutions will collaborate to assess, protect, market,
license, and share in the revenues received from licensing jointly-
owned intellectual property.
Option Agreements: Industrial test drive

Option agreements, or option clauses within research agreements,
describe the conditions under which UNeMed preserves the
opportunity for a third party to negotiate a license for intellectual
property. Option clauses are often provided in a sponsored research
agreement with corporate partners. Option agreements are also
entered into with third parties who wish to evaluate a technology
before entering a full license agreement.
Royalty Sharing Agreements: Splitting proceeds

A royalty sharing agreement is a formal document signed by each
inventor of one or more technologies included in a license. The
agreement spells out exactly how inventor proceeds from the license
will be distributed between the inventors.
Consulting Agreements: To each their own

When personnel enter into consulting agreements, they are deemed
to be acting outside of the scope of their employment. Therefore,
UNeMed does not formally review or negotiate consulting
arrangements. Personnel who enter into consulting agreements
should familiarize themselves with the appropriate institutional
policies related to consulting activities. The employee is expected to
ensure that the terms of the consulting arrangement are consistent
with policy, including those related to intellectual property
ownership and use, and employment responsibilities. UNeMed
can, and often does, provide informal advice on how consulting
agreements relate to an inventor's intellectual property. Inventors
are strongly advised to be careful not to enter into an overly broad
agreement that surrenders their intellectual property rights.
32 UNEMED.COM
OTHER
CONSIDERATIONS
Conflict of Interest seek guidance from the Sponsored

A conflict of interest can occur when Programs Administration for
an employee, through a relationship research-related issues. For license-
with an outside organization, is in a related issues contact UNeMed for
position to: guidance.
1. Influence the University’s business, There are two times in particular when
research or other areas that may guidance is required: When research
lead to direct or indirect financial
gain. proposals are submitted to external
2. Adversely impact or influence sponsors; and when a faculty member,
one’s research or teaching or any university employee, has an
responsibilities. equity or management interest in a
3. Provide improper advantage to company that is considering entering
others, to the disadvantage of the into a license, option or material
University. transfer agreement with the University.
The specific conflict of interest policy
for the University of Nebraska Medical Issues of concern
Center is listed on page 61 in the The main things reviewers look for when
appendix or can be found online at examining potential conflicts of interest
https://wiki.unmc.edu/index.php/ are if the work is an appropriate use
Conflict_of_Interest. of research; the treatment and roles of
Policies specific to the University of students; the supervision of individuals
Nebraska at Omaha were not available working at both the University and
at time of publication. at the licensee; and the conflict of
commitment or the employee's ability to
meet University obligations.
Guidance
When in doubt, inventors should
UNEMED.COM
OTHER CONSIDERATIONS
Outside employment or of the UNMC employment agreement
Veterans Affairs appointment and policies.
Undisputable ownership of the
intellectual property rights is
an essential requirement for the International Research
University to be able to move All UNMC research conducted at
forward in licensing a technology to a another site, including in another
commercial partner. country, must comply with all
applicable federal and state laws and
In essence, before licensing, the University of Nebraska policies. A
intellectual property needs to have questionnaire will help prepare for
a clear title record, in the same way performing research while abroad or
that it is necessary before transfering for performing collaborative research
ownership for a car or home. with researchers who are in another
The common problem for intellectual country. Submit the questionnaire
property rights is when an inventor to the Sponsored Programs
has multiple employers, each with Administration as part of the planning
a contract or policy dictating it process.
has ownership to the rights of the Important considerations include:
invention. The result is that two
Human subjects research must still be
entities own an invention and may performed to the same standards as
have different plans for it. This can be required at UNMC, including approval
problematic at times, especially if it is by the UNMC IRB committee in
not immediately known and disclosed addition to the collaborating institution
in the NIN. But UNeMed has a solid or local review board.
track record of being able to consolidate Animal research must be performed in
the rights for each co-owned invention an approved facility and the project
through inter-institutional agreements. approved by the UNMC IACUC as well
Those agreements clear any title as by the collaborating institution.
disputes and enable UNeMed to move Intellectual property or research that
forward with licensing the invention to may result in new intellectual property
commercial partners. may require a separate New Invention
For example, UNMC physicians Notification for the country in question.
with appointments with the U.S. The Department of Transportation has
Department of Veterans Affairs need developed specific rules for the
to disclose their appointment in any transportation of biological materials,
NIN so that UNeMed can work with including infectious disease specimens.
the VA to account for any rights the The U.S. government has established
VA may have to the invention. controls on the export of strategic goods
and technologies.
In other situations, an inventor that
has entered into a consulting or other Additional information for
contract that may usurp the rights of international projects can be found at:
UNMC, leaving the inventor in breach unmc.edu/academicaffairs/compliance/
areas/export
34 UNEMED.COM
Getting started hardware, software, materials, and
An international project questionnaire data, as well as the provision of
is available to prepare researchers technical assistance to foreign persons
for international projects and travel. inside or outside the United States. See
Anyone preparing an international UNMC export control policy 8005 on
project or grant must complete the page 58.
questionnaire, which might also be Export controls apply to, but are not
requested for international travel. limited to, the following activities:
The International Projects Research activities conducted in the
Questionnaire addresses these areas: United States involving equipment,
General Project Information materials, or data subject to export
controls, including nuclear, biological,
Human Subjects or chemical materials, radionuclides,
Animal Use human and animal pathogens, and
Materials and Equipment novel compounds
Personnel Research activities conducted outside
the United States
Logistics
Research where the sponsor prohibits or
Travel restricts participation by foreign
Conflict of Interest nationals
Intellectual Property Research where the sponsor prohibits or
restricts publishing the results
Shipping or hand-carrying equipment,
Submit completed questionnaires to: materials, software, or data to a foreign
SPAdmin with the application, if country
applying for external funding Electronically transferring data or
Export Control Office, exportcontrol@ software to a recipient in a foreign
unmc.edu country, or to a foreign national or
entity, regardless of location
Travel to an embargoed country for any
Export Controls purpose, including conducting research,
Export controls are U.S. government attending a conference, or participating
regulations that govern the export of in clinical activities.
strategic technologies, equipment,
UNEMED.COM
Plans to discuss unpublished research Shipping infectious substances that can
or other intellectual property with an affect humans or animals (Category
external sponsor, vendor, collaborator, A), biological substances (Category B),
or other third party under a non- or exempt human or animal specimens
disclosure or other confidentiality and dry ice also requires a Training
agreement. and Certification of International
Shippers by the Environmental Health
& Safety department.
Shipping or carrying Any exports totaling $2,500 or more
items abroad for research must be filed with Customs and Border
Exports of physical items, including Protection.
by shipping, hand-carrying, or
Contact the Export Control Office
checked luggage, are subject to
prior to international shipping or
federal regulations and University of
traveling with research items, for more
Nebraska policy. A Request for Export
information or for assistance with
Controls Review Application form
export license applications and other
must be completed prior to shipping
required filings.
or traveling to another country with
research items. The form must provide
specific information about the items Required budget authorizations
to be exported, the intended recipient All sponsored project budgets with
and destination, and the intended international components are to apply
end-use. the appropriate UNMC federally
An export license may be required negotiated F&A rate. Authorizations
depending on the item and destination for contracts unrelated to research
36 UNEMED.COM
should be submitted to the Associate

Vice Chancellor for Business and
Finance or the Director of Business
Services at 402-559-5200.
International activities unrelated
to research may still be subject
to export controls. Please contact International research
the Export Control Office with programs and resources at UNMC
any questions about international Asia Pacific Rim Development
activities. Program, for questions regarding travel
to and within China.
International Travel Pediatric International Research, for
pediatric investigators interested in
All travel outside of the United States
international research collaborations,
for UNMC business, education, or Program Coordinator 402-559-8845
research purposes must be submitted
to the Vice Chancellor for Business International Health and Medical
Education, for general information
and Finance for authorization. regarding international travel,
International travel will be evaluated education, and resources.
by the Compliance Office and/or the Center for Global Health and
Export Control Office. International Development, a College of Public
travelers may be asked to provide Health resource focused on
additional information regarding international public health education,
the scope of activities while traveling research, and practice.
abroad.
Contacts for international
Carrying a computer or other research requirements:
devices outside the U.S. International Research Projects:
Departmental IT workstation SPAdmin, 402-559-7456
specialists will help determine Export Controls: Export Control Office,
if any restrictions may prevent 402-559-4518
bringing an electronic device to a
foreign country. They can also help
determine how best to access email
or other databases off site.
UNEMED.COM
CONSIDERATIONS FOR
STARTUPS
It doesn’t happen often, but innovations. But those same

there are certain technologies industrial partners might be
and inventions where it makes willing to acquire a startup
the most sense to start a new company that has worked out a
company. The reasons for lot of those questions and "de-
starting a technology-based risked" the technology.
company are varied and depend There are also times when an
on a number of factors that inventor has the right kind of
include the particular industrial entrepreneurial spirit that can
sector, the stage of research or make a new company work.
innovation, and the very nature
of the related technology. In any case, UNeMed will
always prefer the route that
Most often, UNeMed helps an gives a technology and its
inventor build a startup when inventor their best chance for
it appears unlikely that further ultimate success—whether
development is possible with an that’s negotiating a licensing
established company. Potential deal with a large multinational
industrial partners—those with corporation, working out a
the resources to finance such sponsored research agreement
costly development—hesitate to with a small niche-market
invest in something surrounded biotech firm, or launching a new
by the level of uncertainty startup.
often found with early-stage
38 UNEMED.COM
STARTUPS
A few key factors when considering a startup company:
n Development risk: Early-stage technologies are risky and
require a significant investment of time and money.
n Development costs versus investment return: Investors do not
merely want to break even. Can the invention and its startup
company meet those expectations?
n Potential for multiple products or services from the same
technology: Few companies survive on one product alone.
n Market position: Would a startup possess a sufficiently large
competitive advantage and target market?
n Sustainability: Are potential revenues sufficient to sustain and
grow a company?
n Business-sense: It's critically important to have someone run
the new company who has startup experience and investor
contacts.
UNeMed staff has significant involvement of any kind is also

experience with start-up reviewed by a UNMC Conflict
companies, has deep ties within of Interest Committee (See
the local entrepreneurial page 65). Typically, startup
ecosystem, and would be happy companies with the most success
to help inventors evaluate these are those that bring in or are led
and other factors. by a person with sound business
training. Usually, the inventor is
The inventor's role in a startup best left to focus on developing
Inventors typically serve as the technology or serving in a
technology consultants, advisers scientific advisory role.
or in some other technical
developmental capacity. Rarely Commitment
do inventors choose to join the Starting a company requires a
startup full-time. In many cases, considerable amount of time,
the inventor’s role is suggested money and effort: More than
by the startup's investors and most realize. It's often been
management team, who identify compared to having a child.
the inventor’s best role based on That level of commitment and
expertise and interests. resources makes it essential to
As a company matures, and have in place a management
additional investment is team experienced in business.
required, an inventor’s role The inventor will need to
may change. At UNMC, faculty champion the formation effort
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STARTUPS
until the management team expected to pay for its own legal
is in place. After the team is matters, including all business
in place, effort is required for incorporation matters and
investor discussions, formal licensing expenses.
responsibilities in or with the
company, and institutional Legal issues
processes such as conflict of In addition to corporate
interest reviews. counsel, the startup may need
its own intellectual property
Startup equity as terms counsel to assist with corporate
UNeMed can accept equity patent strategy, especially if the
as part of the financial terms company will be involved in a
of a license. Equity may patent-rich area. The startup’s
be substituted for other counsel must be separate from
considerations that are often UNeMed's counsel, though it
difficult for a startup. It is also is advisable and recommended
a way for UNeMed to share that the startup counsel and
some of the risk associated with the UNeMed patent counsel
the startup. UNeMed is always coordinate activities. Also, it is
interested in helping a startup wise for investors' counsel to
succeed, and will take any review agreements regarding
reasonable measures to help in roles within the startup to
that end. ensure that all personal
ramifications—including
Lonely startups taxation and liabilities—are
As a separate entity, a startup is clearly understood.
One example of a successful

University startup is Virtual
Incision, the result of a
collaboration between a surgeon
and a robotics engineer. Virtual
Incision builds small robots
(right) in an attempt to redefine
minimally invasive surgery.
Photo: Virtual Incision
40 UNEMED.COM
STARTUPS
So, you want to startup…
University faculty, staff and students thinking of starting a company
with their own technology should evaluate whether it makes good
business sense. Biotechnology companies typically require years of
research and development before generating revenue. The need for
capital investment and development financing is a constant pursuit.
To start a company with a University technology, a founder should
first be able to answer these questions:
1. What is the first product, and how much work is needed before
it can be sold?
2. Who are the customers, and how does the product address their
needs?
3. What is the product development plan, and how much money
will be needed to complete it?
4. Will there be a sole founder of the company or will there be
others?
5. What personnel will help the company overcome obstacles, and
how can they be attracted to the company?
6. How will the company be funded in the beginning?
7. What incentives can be offered to potential investors?
8. What obstacles are anticipated, and how will they be overcome?
Complete a business plan or the innovation. That is an

Inventors who wish to build a important distinction.
startup company with UNeMed's The scientific merits of an
support, will first need to write invention might be intellectually
and submit a full business plan. interesting, but investors
Then, the inventor can license want one thing: a return on
their technology from UNeMed. investment. Experiments
(Yes, an inventor will have to must work, the data must be
sign a licensing agreement, published, and the intellectual
even for a technology they property must be protected. But
invented because, technically, that is still not enough.
the invention is actually owned
by the Board of Regents of the Investors fund companies that
University of Nebraska.) can demonstrate how good
science, published results and
There are many online guides strong patents will eventually
on how to write a good business turn into a massive profit.
plan, but a founder must make a
compelling case for their startup Make that case to UNeMed
company, not just the research first. UNeMed will help refine
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STARTUPS
the message before meeting limited liability companies.
potential investors. As an UNeMed can help explain those
aspiring entrepreneur, founders options, and what might be
will need to draft a business plan best. But the final decision is
that communicates the financial between the inventor/founder,
plans, market opportunity and any co-founders, investors and
vision of the company. the startup's lawyers.
Decisions, decisions Second, who makes the
The company needs to be ultimate decisions about the
registered and incorporated to company? It doesn’t matter if
become a legal entity. Then a it’s a shareholder agreement, a
CEO must be selected to run management agreement or even
the company. The CEO and a handshake with a co-founder.
founder/inventor will negotiate In any case, UNeMed will need
a license for the technology with to know how the company is
UNeMed. going to make decisions and
First, hire a lawyer and consult what rules will govern disputes.
with co-founders about whether A CEO will need to be selected
it’s a good idea to create a new to run the company. The CEO
company. Review with them should be someone other than
the business plan, and discuss the inventor. Researchers are
options and best ways to set up a great at what they do and
new business. There are a variety while some may be good
of legal structures for businesses: with business, the job of a
partnerships, corporations and CEO includes things that
Radux is another
example of a
successful University
of Nebraska startup.
Radux is built on the
"Stand Tall" device
(left), which is a
disposable mounting
bracket that allows
interventional
radiologists to
work more safely
and comfortably
in flouroscopic
and radiological
procedures.
Photo: Radux
42 UNEMED.COM
STARTUPS
can’t be delegated. The CEO milestones are met.
is responsible for setting the UNeMed can provide guidance
company strategy and direction, for registering for federal grant
modeling and creating the programs and several state-level
company’s culture, building and grant programs that might help
leading the executive team, as the company get started.
well as raising and allocating
company funds. A well- UNeMed’s recent successes
seasoned CEO is the best bet for in startup formation can be
commercial success. partially attributed to a more
concentrated effort in the area,
Third, is there intellectual but Nebraska has also become
property? The University will a more fertile entrepreneurial
treat an inventor like any environment in recent years.
other company that licenses Government incentives, local
its intellectual property, even directives and several mentoring
its own inventors. The newly- and funding programs all
formed company will need to helped cultivate the burgeoning
pay royalties for future products, startup scene in Omaha and
commit to a developmental plan, surrounding areas.
reimburse the University for
intellectual property costs, and UNeMed plays an active role
pay additional costs of renewing in this ecosystem, participating
or continuing that protection. in local entrepreneurial
organizations such as UNeTech,
Fourth, know there are options The Startup Collaborative,
when licensing a technology Pipeline, StraightShot and
from UNeMed. Perhaps the NMotion. We can serve as
company would like to raise a concierge to make the
a small amount of capital to introductions and help any
determine the technology’s entrepreneurial inventor make
feasibility. Before signing a the most of that ecosystem.
license agreement, the company
may be able to negotiate a short- Always remember: UNeMed
term option agreement that has been a party to more than
allows the company to further 60 startups over the years,
evaluate the technology and and UNeMed wants each and
begin fundraising. every one of them to succeed.
UNeMed has a vested interest—
in time, treasure and a desire
Mentoring to bring biomedical innovation
Once a license is executed, the to market—in helping a new
company will have an ongoing University-based startup achieve
relationship with UNeMed for its goals. UNeMed will be an
support and assurance that inventor-founder's greatest asset
contractual obligations and and ally.
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APPENDIX I
POLICIES
University of Nebraska Board of Regents Policies
Board of Regents Bylaws 4.4 Intellectual Property
3.10 Ownership and Commercialization of 4.4.1 Ownership of Intellectual Property
Inventions and Discoveries. Central to the University of Nebraska’s
mission is the creation, preservation, and
The Board encourages the dissemination of knowledge.
commercialization of inventions and
discoveries arising from research activities The University of Nebraska is committed
of the University, and when appropriate, to providing an environment that supports
the pursuit of patents or other intellectual the research, teaching, and service
property protection, as a method of activities of its faculty, students, and staff.
bringing recognition and remuneration As a matter of principle and practice, the
to the University's inventors and to University encourages all members of the
the University itself. Every invention or University community to publish their
discovery by members of the faculty and articles, books, and other forms of scholarly
staff that results from the performance of communication in order to share openly
duties within the scope of their University and fully their findings and knowledge
employment, or from the use of University with colleagues and the public. This Policy
personnel, property, facilities, or other is intended to promote and encourage
resources, except where such use is excellence and innovation in scholarly
minimal, shall be solely owned by the research and teaching by identifying and
University provided that the inventor or protecting the rights of the University, its
inventors shall have a share of no less faculty, staff, and students.
than one-third (1/3) of the net proceeds Patent and copyright ownership and their
received by the University resulting from associated rights are concepts that are
licensing or sale of University owned defined by federal law. This Policy and the
intellectual property rights associated with University’s patent policies are structured
such invention or discovery. Further, and within the context of those federal laws.
unless otherwise explicitly and specifically The University’s patent policies have been
agreed to in writing, should by operation in operation within the University for many
of law or otherwise it is determined that years and are hereby incorporated into this
the inventor or inventors own any rights in Policy.
the University's inventions and discoveries The long standing academic tradition that
beyond that described in this section of faculty own the copyright to academic,
these Bylaws, then it shall be a condition of scholarly and educational works resulting
employment at the University of Nebraska from their research, teaching, and writing
that any such rights shall be assigned to the is the foundation of the copyright policy
University. The Board shall adopt a formal described in this document. Exceptions
Patent and Technology Transfer Policy which to this rule may result from contractual
shall govern the disclosure of inventions obligations, from employment obligations,
and discoveries resulting from performance from certain uses of University facilities, or
of duties by faculty or staff within the by agreement governing access to certain
scope of their employment, or from the University resources. This Policy is intended
use of University personnel, property, to clarify many of these situations.
facilities, or resources. The President, or any As used in this Policy, “University” shall
administrative officers designated by the refer to the University of Nebraska or
President, shall have authority to act for one of its campuses and shall include
the University with respect to inventions any organization of the University
or discoveries owned by the University as whose primary purpose is to facilitate
required by this section and the Board's technology transfer and commercialization
Patent and Technology Transfer Policy. of the University’s Intellectual Property.
“Intellectual Property” shall include, but
44 UNEMED.COM
APPENDIX I: POLICIES
is not limited to patentable inventions, and those persons engaged in creative
mask works, tangible research property, efforts at the University. In some
trademarks, and copyrightable works, instances, the result of the creative
including software. effort will be the property of the
This Policy is included in the terms of University, while in others some or all of
employment of all University employees. these rights of ownership shall belong
Admission as a student at the University to the Author or Inventor. Where
constitutes an agreement to abide by the ownership rests with the University, the
terms of this Policy. University will seek to recognize and
provide incentives for those persons
1. General Policy Statement
who make significant contributions to
The prompt and open dissemination the University’s mission.
of the results of research undertaken
In some instances it may be difficult
at the University of Nebraska and the
to foresee with certainty whether
free exchange of information among
Intellectual Property created in a
scholars are essential to the fulfillment
particular context is the property of
of the University's obligations as an
the University or the employee. In such
institution committed to excellence
instances, the employee is encouraged
in research, education, and service.
to disclose in writing the nature of any
Matters of ownership, distribution, and
creative endeavor that has potential
commercial development nonetheless
commercial applications as soon as
arise in the context of technology transfer,
possible to the employee’s immediate
which is also an important aspect of the
administrative supervisor. This
University's commitment to public service.
disclosure will provide an opportunity
The University of Nebraska as a public
to discuss incentives, seek any
institution has a responsibility to recognize
necessary interpretation of this Policy,
the State’s contribution of tax support for
and secure the University’s support for
research and creative activity by devoting
the creative endeavor.
an appropriate share of the products of
that research to the further benefit of the b. Use of University’s name
University as a whole. The University must The University has an interest in how
also recognize the intellectual contribution its name is used and an interest in
of Authors and Inventors, the need to protecting the value of that name.
provide incentives for enhanced intellectual Individual Authors or Inventors
activity, and the role such incentives play in cannot alone decide whether a
recruiting and retaining creative individuals project should be associated with
at the University. the University’s name. An employee
“Author(s)” and/or “Inventor(s)” are defined of the University may identify his or
herein as faculty, staff, and other persons her affiliation with the University, but
employed by the University of Nebraska, without prior written approval, may
whether full or part-time; visiting faculty not otherwise suggest the University’s
and researchers; and any other persons, participation or endorsement of the
including students, who create or discover conclusions of any study or research.
Intellectual Property using University Similarly, the University’s name may
resources, as those terms are subsequently not be used, without prior written
defined. permission, in association with the sale
or commercialization of the products
2. Early Disclosure and Incentives for
of research by University employees.
Creative Effort; Use of the University’s
Again, early written disclosure
Name
will facilitate agreement between
a. Early disclosure and incentives to create interested parties.
This Policy is a framework to provide 3. Ownership of Intellectual Property;
guidance in understanding the General Provisions
relationship between the University
a. Applicable to all technologies and
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media to continue the creative process.
The issue of ownership of Intellectual Therefore, except in such instances
Property resulting from activities where the University can show that
of University employees arises in a its interests will be significantly
number of different contexts involving compromised, an Author or Inventor,
a variety of creative works. Increasingly, while still in the employ of the
University employees utilize new University, shall be permitted to make
technologies and media to create new revisions to and develop new works
inventions, to improve the educational based upon the original creation.
process, and to enhance the delivery Except to the extent that an Author or
and exchange of information. This Inventor may have a right to receive
Policy is intended to apply to all income based upon royalties or other
creative works, except patentable fees generated from a work, this Policy
subject matter, regardless of the provides no portability of other rights
media in which they are distributed to University-owned Intellectual
or the nature of their technological Property should the employment
manifestation, now known or later relationship between the University
developed. and the Author or Inventor terminate.
However, in many cases it may prove
b. Patent policies not affected
possible for the University to grant a
Notwithstanding anything otherwise royalty-free license or an appropriate
stated in this Policy, ownership royalty-bearing license to the Author
of patents shall be determined in or Inventor to continue to use the
accordance with University patent techniques or other aspects of a
policies in Section 3.10 of the Bylaws of creative work, even when the Author or
the Board of Regents of the University Inventor is no longer employed by the
of Nebraska and Regents Policy 4.4.2, or University.
as those patent policies may from time
Comment
to time be amended.
When a faculty member leaves the
It is essential, however, that Authors employment of the University, the
and/or Inventors understand that University will continue to honor the
early publication of their patentable terms of any agreement it has with the
research results without notification faculty member regarding University-
to the University can compromise owned Intellectual Property. For
the University’s patent rights in the example, the University may agree to
research, and by implication, the pay a faculty member a royalty for the
Authors ’ and/or Inventors’ royalty development of a University-owned
interest therein. Therefore, if an Author distance learning program. If the
or Inventor wishes to publish research faculty member leaves, the University
results which involve patentable will continue to pay in accordance
subject matter, the Author or Inventor with the agreement with the faculty
should first submit a patent disclosure member. The faculty member may
to the University patent administrator not, however, take other rights of
and also disclose the existence of the ownership in the Intellectual Property,
pending publication so as to allow for unlessit is agreed to by separate written
the appropriate filings to preserve the license agreement between the faculty
University’s patent rights. member and the University.
c. Residual Authors’ or Inventors’ Rights d. Classification of creative works
Notwithstanding the University's The ownership of Intellectual Property
ownership of any particular created by a University employee
Intellectual Property, the University is determined by the nature of the
shall not engage in any activity activity resulting in the Intellectual
which unreasonably interferes with Property. Under this Policy, Intellectual
an Author’s or Inventor’s ability
46 UNEMED.COM
Property not governed by Section 3.b developed at their own initiative,
(Patent Policy) is classified as either: without the use of any University
1) an Independent Work governed resources, and not pursuant to an
by Section 4; approved agreement. The University
does not claim ownership of
2) a University Supported Work
books, articles and other scholarly
governed by Section 5;
publications, or to popular novels,
3) an Institutional Work governed by poems, musical compositions, or other
Section 6; or works of artistic imagination that
4) a Contractual Work governed by are created by the personal effort of
Section 7. faculty, staff and students and which do
The ownership of Intellectual Property not make use of University resources.
produced by non-employees, including 5. University Supported Works
students, arising out of activities a. University Supported Work defined
associated with the University is
A University Supported Work is a
governed by Sections 8 and 9 of this
creative work developed in whole
Policy.
or in part with the customary use
Comment of University resources. "University
The intent of this section is to resources" means all tangible resources
categorize all works which may contain provided by the University of Nebraska
Intellectual Property rights into one of to Authors or Inventors, including
the listed categories and to allocate the salary, office, lab, studio space and
Intellectual Property rights accordingly. equipment; computer hardware,
Thus any work must be in only one software, and support; secretarial
category. It should be understood that service; research, teaching, and lab
the determination of whether a work assistants; supplies; utilities; funding for
is an Independent Work, a University research and teaching activities; travel;
Supported Work, or an Institutional and other funding or reimbursement.
Work depends on the context in which
b. Ownership of University Supported
the work is created. Any of these works
Works that do not involve use of
may be transformed into a Contractual
substantial University resources
Work by an agreement between the
University and the Author or Inventor. By long-standing tradition and
the contemporary need to remain
4. Independent Works
competitive in recruiting and retaining
a. Independent Works Defined; a creative faculty, the faculty own the
Ownership copyright and other rights associated
An Independent Work is a work that is with Traditional Works of Scholarship.
not: "Traditional Works of Scholarship"
1) a University Supported Work, are defined as works reflecting
pursuant to Section 5; research or creativity which, within
2) an Institutional Work, pursuant to the University, are considered as
Section 6; or evidence of professional advancement
or accomplishment. Such works result
3) a Contractual Work, pursuant to from scholarly endeavors, and include
Section 7. instructional materials, journal articles,
A University employee as the Author or research bulletins, monographs, books,
Inventor of an Independent Work owns plays, poems, and artistic works, and do
the Intellectual Property rights in that not involve substantial use of University
work. resources as described in Section 5.c of
Comment this Policy. Accordingly, except for (1)
It is the policy of the University of University Supported Works involving
Nebraska that faculty shall own all use of substantial University resources,
rights to materials prepared and and (2) patents, patentable subject
UNEMED.COM
matter, trade secrets and commercially the process of delivering a course
viable discoveries and inventions of instruction to students shall
governed by the patent policies be the property of the faculty
described in Section 3.b of this Policy, member. However, in the absence
the faculty member shall own the of a specific written agreement,
copyright and have the right to register and with the exception of books or
the same and to receive royalties other educational materials covered
or other income from a University by Section 3.11 of the Bylaws of
Supported Work, including books, the Board of Regents, no royalty,
films, cassettes, CDs, software, works rent or other consideration shall
of art, or other material. However, such be paid to a faculty member when
ownership and rights are subject to Instructional Materials are used at
the requirements of Section 3.11 of the the University. Should the Author
Bylaws of the Board of Regents of the of Instructional Materials depart
University of Nebraska prohibiting a the employ of the University, he
faculty member from having a financial or she will provide the University
interest in or receiving compensation with copies of the Instructional
from the sale of educational materials Materials (not including lecture
used by students of the University, notes) and shall grant the University
except royalties on books or other a non-exclusive, royalty free license
educational material from publishing thereto, when it is determined by
houses of standing. In addition, the University that such Instructional
the following specific rules apply Materials are necessary to carry out
to University Supported Works for the educational programs of the
which the faculty member owns the University. Recordings of lectures
copyright: shall be the property of the faculty
1) Research Materials. Materials lecturer, unless the recording is an
such as lab notebooks and research Institutional Work or a University
files shall remain the property Supported Work Involving use of
of the individual responsible for substantial University resources.
directing the project, except when c. Ownership of University Supported
agreements governing Contractual Works involving use of substantial
Works described in Section 7 require University resources
otherwise. However, should such 1) Notwithstanding Section 5.b,
an individual depart the employ in circumstances in which use of
of the University or otherwise substantial University resources is
terminate responsibility for directing involved in the creation of a work,
the project, he or she shall provide the University shall own the work,
the University with such copies including the right to obtain a
of the research material as may copyright and the right to royalties
be reasonable in order that the or other income. Circumstances
University may protect its rights in involving use of substantial
any Intellectual Property as well as University resources include:
that of the departing Author’s or
a) substantial University financial,
Inventor’s colleagues.
staff, or other assistance;
2) Instructional Materials.
b) extensive use of special or
"Instructional Materials" are
rare University holdings, such as
other than Institutional Works,
museum collections;
the primary use of which is for
the instruction of students. Such c) significant use of voice or
works include textbooks, syllabi, image of students or staff in a
lectures, lecture notes, and study product (other than the author or
guides. Instructional Materials inventor), or substantial creative
developed by a faculty member in contribution by staff or students
48 UNEMED.COM
to the preparation of a work or 2) When the responsible Dean or
product; or Director determines that any of
d) use of the name or insignia of the the circumstances involving use
University or any of its units (other of substantial University resources
than for purposes of identification described above in subparagraph 1) of
of individual faculty members) this Section 5.cobtain, the University
to identify or to promote the will accord to the Author a non-
distribution of a work or product, or exclusive, royalty free license to use the
other identification or promotion work for non-commercial purposes.
that implies the approval or Further, and in keeping with the
endorsement by the University or University’s strong desire to promote
one of its units. creative efforts, the University will
negotiate in good faith with the Author
Comment
to determine the extent to which the
The references in subparagraph a)
Author should share in the rights to
to “substantial University financial
royalties or other “ownership” rights to
staff or other assistance” and in
such work.
subparagraph b) to “special or
rare University holdings, such as Comment
museum collections” mean the The allocation of rights for
use of University funds, facilities, University Supported Works in
equipment, or other resources Section 5 is modeled after the
significantly in excess of the norm policy of Harvard University. It
for educational and research attempts to distinguish between
purposes in the department or unit traditional works of scholarship
in which the creator holds his or her for which faculty members hold
primary appointment. The University the copyright and those works
does not regard the provision of created with substantial University
an employee’s salary, office, usual involvement. Where the University
library resources, usual facilities is involved to a greater extent than
and equipment, and office staff, or ordinarily prevails, the University
personal computers as constituting should be entitled to share in the
“substantial use of University economic returns of resulting works
resources” unless such resources and to receive reimbursement for
were made available specifically its additional costs. It is recognized
to support the development of a that the determination of whether
work to be owned or acquired by a particular project involved
the University or was previously substantial university involvement
designated by the University as may not always be clear. In such
a substantial University resource. circumstances it is important that
The reference in subparagraph the faculty member make early
to c) to “substantial creative disclosure to the Dean or Director
contribution by staff and students” and that, if an interpretation of this
means providingoriginal ideas or policy is required, the procedures
new techniques that are essential adopted in Section 13 be initiated.
to the creation of the product or 6. Institutional Works
significantly improve its value. For a. Institutional Works defined
example, devising a new way to
An Institutional Work is a work created at
test one of the major hypotheses
the specific instigation of the University
in a study would normally count as
and under the specific direction of the
such a contribution, but providing
University, by a person acting within
ordinary research assistance or
the scope of his or her University
conducting standard data analysis
employment. Institutional Works are
would not.
often referred to in copyright law as
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works-made-for-hire. A creative work entitled to share in any financial returns
produced on the initiative of a faculty from the work.
member pursuant only to the general 7. Contractual Works (Sponsored
obligation of faculty members to Research)
engage in research or creative activity
Ownership of the Intellectual Property
is not an Institutional Work, but may be
rights in creative works developed in the
a University Supported Work involving
course of or pursuant to a sponsored
use of substantial University resources
research program or other contractual
as described in Section 5.cof this Policy
arrangement will be determined
or a Contractual Work as defined and
according to the terms of such program
described in Section 7 of this Policy.
or contract, provided that the program or
However, Institutional Works may
contract was approved by the University.
include creative works generated
If the program or contract does not
within a specific project initiated by
provide for the allocation of Intellectual
the University. Institutional Works also
Property rights, such rights will be
include committee minutes, internal
determined by the other provisions of this
memoranda, business files, personnel
Policy. Notwithstanding other provisions
files and other business records created
of this policy, the University may elect to
in the ordinary course of the general
enter into a contract with an individual
administration of the University.
employee regarding the creation of
Comment specific intellectual property.
Institutional Works are works that
Comment
are created at the initiative of the
University personnel and visitors
University. In addition to works
should contact the office on their
related to the general administration
campus responsible for sponsored
of the University, such as committee
programs for information or assistance
reports, minutes, and business
regarding drafting or interpretation of
files, an Institutional Work may
research contract terms. The terms of
include more traditional creative
such sponsored research agreements
works. For example, the products
apply not only to inventions made
of a University initiated program
by faculty and staff, but also to those
in distance learning where an
made by students and visitors, whether
employee or numerous employees
or not paid by the University, who
are assigned the specific task of
participate in performing research
creating instructional content would
supported by such agreements. Care
be Institutional Works.
should be taken to assure that any
b. Ownership of Institutional Works contract for sponsored research is
The University owns all rights to approved and signed by a University
Institutional Works. However, in administrative officer having proper
keeping with the University’s strong Authority to approve and sign such a
desire to promote creative efforts, the contract on behalf of the University.
University may determine that the Patents: Research contracts sponsored
Author or Inventor should share in the by the Federal Government are subject
rights to royalties and other rights in to statutes and regulations under
Institutional Works discussed in this which the University acquires title to
Policy. The Author or Inventor should inventions conceived or first reduced
engage in early written disclosure to to practice in the performance of the
the University of the potential for any research. The University's ownership
valuable Intellectual Property rights is often subject to a non-exclusive
associated with Institutional Works in license or grant of other rights to the
order to facilitate agreement regarding government and the requirement that
such shared rights. Failure to do so will the University retains title and take
be an important factor in assessing effective steps to develop the practical
whether the Author or Inventor is
50 UNEMED.COM
applications of the invention by degree award, grant royalty-free
licensing and other means. non-exclusive permission to the
Contracts with outside research University to store copies of such
sponsors are negotiated on a case- works for archival purposes and to
by-case basis with ownership and reproduce and publicly distribute
other rights to the discovery of any copies of his or her thesis or
patentable invention determined in the dissertation within the University
course of the negotiations. education and research missions;
provided however, that should the
Copyright: Normally, research contracts
student identify any legitimate
sponsored by the Federal Government
proprietary interest the student
provide the government with specified
may have in the work, or should the
rights in copyrightable material
University determine that it has an
developed in the performance of the
ownership interest in any patentable
research. These rights may sometimes
or otherwise protectable Intellectual
place title to such material exclusively
Property interest in the work, the
in the government, but more often
University shall then delay any public
consist of a royalty-free license to the
access to the work for up to one
government with title vesting in the
year following the presentation of
University.
the work, in order for the student to
When a work is created under the terms consult with the University regarding
of a sponsored research agreement, the protection of the proprietary
Authors of copyrightable works should interest. Copyright ownership of
be aware that there may be contractual theses or dissertations generated by
terms relating to the form of the research that is performed in whole
research report, advance notice to the or in part by a student with the
sponsor before publication, and other support of a sponsor or grant shall
limitations or obligations. be determined in accordance with
8. Ownership of Works Produced by Non- the terms of the sponsored research
employees or grant agreement, or in the
According to federal law, copyright of absence of such terms, the copyright
commissioned works of non-employees shall be owned by the University.
is owned by the Author and not by the b. Software, Patentable Subject
commissioning party, unless there is a Matter and Non-Copyright Intellectual
written agreement to the contrary. All Property
University personnel are cautioned to Software, patentable subject matter,
ensure that independent contractors and other Intellectual Property
agree in writing that ownership of (other than copyright as described
commissioned work is assigned to in Section 9.aand Section 9.cof
the University, except where special the Policy) contained or disclosed
circumstances apply and it is mutually in theses, dissertations and other
agreed that the Author will retain student works shall be subject to
ownership. and governed by the policies that
9. Ownership of Copyrights in Theses, apply to University employees.
Dissertations and Other Student Works c. Student Writings Other Than Theses
The ownership of copyrights in student or Dissertations
works is governed as follows: Students shall own the copyrights to
a. Theses, Dissertations and Other all student writings not commonly
Student Works referred to as theses or dissertations
Students will own the copyrights and to other creative expressions
to their theses, dissertations, and required in the course of class
other student works; however, a assignments. The University shall
student must, as a condition to a retain the right to keep original
examination scripts and to possess
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a copy or record of other student Institutional Works will be owned by
works for purposes of assigning the University; ownership of trademarks
grades, maintaining archival that are University Supported Works
materials, and record keeping. will be determined by the provisions of
Comment Section 5 of this Policy; and ownership
In cases where a dissertation or of trademarks that are Contractual Works
thesis contains patentable or will be determined by the provisions of
otherwise protectable subject Section 7 of this Policy. Note however,
matter belonging to the University, that the University owns many valuable
the students and faculty involved trade and service marks, most of which
with the project have a duty to are registered with the appropriate state
disclose the existence of the thesis or federal agencies. Any trade or service
or dissertation to the University marks derived from or based upon
office responsible for patent University-owned marks shall belong to
matters. The students and/or faculty the University.
members should also contact the 12. Assignment of Property Rights by the
campus Dean for Graduate Studies University
regarding the shelving of the thesis The University may assign to the Author
or dissertation with the University’s or Inventor any rights of ownership it may
Library. The campus Dean can acquire pursuant to this Policy.
provide for the secured storage of
13. Resolution of Ambiguities and Policy
the thesis or dissertation for up to
Interpretation
one year so as to preserve the patent
or other rights of the University in Should any issue arise regarding
the subject matter of the thesis or interpretation of this Policy, for example,
dissertation. whether Use of Substantial University
resources has occurred or will occur, the
10. Intellectual Property Rights for
issue shall be referred to the Author’s
Multiple Creating Parties
or Inventor’s Dean, Director, or similarly
Due to the nature of current research situated administrator. After reviewing
practices and multi-media creations, it is the relevant facts, such administrator
common for more than one individual to shall recommend a resolution to the
claim part of the recognition as Author Vice Chancellor responsible for research,
or Inventor for a particular creation. In sponsored programs and technology
such instances, participating Authors transfer (e.g. Vice Chancellor for Research
or Inventors are strongly encouraged or Vice Chancellor for Academic
to define their respective rights to Affairs). Any campus may establish a
the creation in a written agreement, committee of peers to review the facts
signed by all of the contributing parties. and circumstances surrounding any
Misunderstandings between the particular interpretation of this Policy
contributing parties can be avoided if and make recommendations to the Vice
such agreements are entered into as early Chancellor. The Chancellor will make the
as is practicably possible. Should the co- final decision on all interpretations under
Authors or co-Inventors fail to so agree in this Policy, based on the recommendation
writing, it is presumed that any benefits of the Vice Chancellor. The Chancellor’s
to be shared by them shall be shared decision will be final with respect to the
equally. University.
11. Ownership of Trade and Service 14. Supplemental Income from
Marks Commercial Applications
Ownership of trademarks shall be This Policy on ownership rights in no way
governed by the provisions of this alters the ability of an Author or Inventor
Policy. Thus, trademarks that are to receive supplementary income from
Independent Works will be owned the University under any separate policy,
by the Author; trademarks that are as a result of the commercial application
52 UNEMED.COM
of Intellectual Property created by the concerning whether a use of University
Author or Inventor. resources is minimal shall be resolved
15. Review of Policy in accordance with the process set forth
in Section 9 of this Policy. Each such
This policy will be reviewed periodically
invention and any improvement(s) made
and revised as deemed necessary to
thereto while under the employment
accommodate new technologies and
of the University shall be promptly
to incorporate changes warranted by
disclosed in writing to the designated
experience with its administration.
campus patent and technology transfer
administrator (the “Administrator”).3
4.4.2 Patent and Technology Transfer A disclosure of an invention shall be
Policy properly made when it is submitted
Section 3.10 of the Bylaws of the to the campus Administrator in such
Board of Regents provides that it is the manner and form as may be determined
policy of the Regents to encourage the by the Administrator. Any disclosure of
commercialization of inventions and an invention shall contain information in
discoveries arising from research activities such detail as is deemed necessary by the
of the University, and when appropriate, Administrator to allow for a review of its
the pursuit of patents or other intellectual patentability and commercial potential,
property protection, as a method of and shall detail the specific utility or
bringing recognition and remuneration application of the invention.
to the University’s inventors and to the 2. The Campus Administrator
University itself. This Patent and Technology
The Chancellor of each campus and/or
Transfer Policy is adopted for the purpose
the Chancellor’s designee shall designate
of providing general policy regulations to
a campus patent and technology transfer
implement Section 3.10 of the Bylaws of the
administrator who shall be responsible
Board of Regents:
for the administration of all campus
1. Ownership of Inventions Resulting From patent and technology transfer activities,
Performance of Duties of Employment; and who will provide a central source
Prompt Disclosure to University of information and help in handling
Each invention1 by a member or the different aspects of patents and
members of the faculty or staff of the technology transfer.
University resulting from performance 3. Patent and Technology Transfer
of duties within the scope of University Advisory Committee
employment, or resulting from the use of
The Administrator in consultation with
University personnel, property, facilities,
the Chancellor and/or the Chancellor’s
or other University resources, except
designee shall establish an advisory
where such use is minimal,2 shall be
committee on technology transfer (the
solely owned by the University. Questions
1. For purposes of this policy, the term “invention” shall mean patent able inventions or discoveries, computer software, trade
secrets and all other intellectual property not addressed under Regents Policy 4.4.1.
2. The determination as to whether any use of University personnel, property or facilities is or was “minimal” under this policy
shall be made based on the following considerations:
a) Whether the invention was conceived of or reduced to practice pursuant to an employee or faculty member’s job duties;
b) Whether any funding for the work leading to the conception or reduction to practice of the invention was provided by or
facilitated through the University;
c) Whether any University facilities were utilized in the conception or reduction to practice of the invention, and if so, the
extent of such use; and
d) Whether any University students or staff were utilized in or contributed to the conception or reduction to practice of the
invention.
3. The Bayh-Dole Act of 1980, 35 U.S.C. §§ 200-212, allows Universities and other non-profit organizations to retain title to
federally-funded inventions and requires that strict reporting requirements be met. It is therefore critical that inventors provide
a prompt and thorough disclosure to the University so that the University can properly evaluate the disclosure and elect to
either retain or decline title to such inventions in a timely manner.
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“Committee”). The Committee will be any reason which in its sole discretion it
available to assist the Administrator in the determines is in the best interests of the
review of disclosures of inventions, and University, assign title to the invention to
provide advice and peer group scientific the inventor(s). In such cases, however,
review on issues relating to (i) intellectual the University may retain a non-exclusive,
property development and licensing or paid-up, royalty-free license to the
other technology transfer issues, and (ii) invention, if it so desires.
other related assistance as requested. Although the University may assign
4. Review of Invention Disclosures; title to an invention to the inventor(s),
Acceptance for Technology Transfer by any improvement or modification to or
University or Transfer to Inventor separate invention derived from or based
The Administrator, the Committee, and/ on such invention that results from the
or the Administrator’s designees (one or use of University personnel, property
more of which are referred to herein as or facilities, except where such use is
the “Reviewers”) shall aim to evaluate all minimal, shall be owned by the University
disclosures of inventions on behalf of the subject to this Policy. The inventor(s) shall
University within six (6) months from the promptly disclose such improvement,
date the disclosure is formally submitted modification or separate invention to the
to the Administrator. The disclosure shall Administrator in the same manner as is
be evaluated by the Reviewers for the described in Section 1 of this Policy.
ability to obtain effective intellectual Should an inventor leave the University
property protection on the invention, and wish to continue research on
and the potential of the invention to an invention which the inventor has
stimulate business interest and contribute disclosed to the University, the University
to economic development. Upon the shall provide an appropriate royalty-free,
conclusion of the Reviewers’ evaluation non-commercial, research only license to
of an invention, the Administrator shall allow the inventor to continue his or her
communicate to the inventor(s) any intent research.
on behalf of the University to pursue 5. Division of Net Royalties and Proceeds
protection of the invention. The University
With respect to any invention subject
shall proceed, in its sole discretion, to
to this Policy, the University shall first
seek appropriate intellectual property
be reimbursed for any and all expenses
protection on the invention, and/or
incurred by it that are associated with
market the invention to interested parties.
evaluation of the technology, obtaining
The terms of any license or agreements
of patent or other intellectual property
related to an invention, and the manner
protection, and licensing or other
in which they may be enforced, litigated
technology transfer activity, including
or settled shall be at the sole discretion of
legal expenses related thereto.4 In the
the University.
event of any infringement action or
The inventor or inventors of a disclosed other legal action involving technology
invention shall assist the University and disclosed under this Policy, the University
any counsel retained by the University in shall also be reimbursed for any and
the preparation, filing and prosecution all expenses borne by the University
of any patent applications based on associated with such action. After such
inventions disclosed to the University, expenses are reimbursed, royalties and
and shall sign any and all necessary other proceeds from licenses or other
documents, including assignments, technology transfer activities related to an
declarations, oaths and affidavits related invention, or patent or other intellectual
thereto. property protection based thereon, shall
At any time during the technology be distributed as follows:
transfer process, the University may, for (a) One-third to the inventor or
4. The University shall make every effort to recover all or part of these expenses from any licensee of
University-owned intellectual property upon the execution of the license agreement.
54 UNEMED.COM
inventors; and University personnel and the University
(b) Two-thirds in accordance with as an entity in the context of intellectual
a separate distribution policy to be property licenses or other contracts
established and implemented by each related to technology transfer activities.
University campus, such policy to take As such it is of utmost importance that
effect following approval by the Board in addition to any compliance required
of Regents upon recommendation of under this Policy, that all involved in
the relevant campus’ Chancellor. technology transfer also comply with any
conflict of interest policies as required by
6. Distribution of Equity to Inventors
law, Section 3.8 of the Bylaws of the Board
In the event that the University receives of Regents or Regents Policy 3.2.8, as
equity or an option to acquire equity those requirements may exist or as they
in exchange for any license or other may be amended in the future.
intellectual property, the share of such
9. Resolution of Issues Concerning
equity due to the inventor(s) shall be
Administration or Interpretation of this
based upon the distribution of royalties
Policy
and proceeds provided in Section 5 of
this Policy. Such equity will be distributed Should any issue arise regarding
directly to the inventor(s) once such administration or interpretation of this
equity is transferable. The University Policy or Section 3.10 of the Bylaws of
shall make every effort to distribute the Board of Regents, the issue shall be
such equity in a timely manner, but the referred to the campus vice chancellor
University shall not be responsible for responsible for research, sponsored
changes in value which might occur programs and/or technology transfer
before receipt of equity by an inventor. activities (e.g. Vice Chancellor for Research
or Vice Chancellor for Academic Affairs).
In the event the University or an affiliated
The campus patent and technology
entity of the University receives equity or
transfer advisory committee may
an option to acquire equity in exchange
review the facts and circumstances
for something other than a license or
surrounding any such issue and make
other intellectual property right (e.g.
recommendations to the Vice Chancellor.
performance of a service or clinical trial),
The Vice Chancellor shall then make
the equity interest shall not be subject to
a report and recommendation for
distribution under Sections 5 or 6 of this
resolution of the issue to the Chancellor,
Policy.
who will make the final decision on all
7. Division of Inventor’s Share Among issues concerning administration or
Co-Inventors interpretation of this Policy or Section
Should there be more than one inventor 3.10 of the Bylaws of the Board of
per license or other source of royalties Regents. The Chancellor’s decision will be
and other proceeds under Sections final with respect to the University.
5(a) and 6 of this Policy, the inventors' 10. Survival of Policy
shares shall be divided and distributed
The provisions of this Policy and
among themselves in accordance with
Section 3.10 of the Bylaws of the Board
an agreement to be signed by the
of Regents shall survive the death or
inventors and filed with the Administrator.
termination of employment of any
Should the inventors fail to sign such
inventor of intellectual property owned
an agreement governing distribution
by the University. The provisions of this
among them, then the proceeds shall be
Policy shall inure to the benefit of and
distributed equally among the sum of
be binding upon the heirs and assigns of
inventors per license or other source of
(1) any inventor of intellectual property
royalties.
owned by the University, and (2) all others
8. Conflicts of Interest who agree to be bound by it.
Conflicts of interest are more likely 11. Campus Patent and Technology
to present themselves to inventors, Transfer Policies and Procedures
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The Chancellor of each campus, or the individuals will be under confidentiality
Chancellor’s designee, is authorized to agreements.
adopt and implement more detailed • The Patent Administrator in consultation
campus patent and technology transfer with the Vice Chancellor for Research may
policies and procedures that are invite other participants with applicable
consistent with and supplemental to expertise to specific meetings as needed.
Section 3.10 of the Bylaws of the Board of
Responsibilities
Regents and this Policy.
• Inventions will be evaluated by STAC
for their potential to obtain effective
UNMC Policy 7000 intellectual property protection; to
Science and Technology Advisory stimulate business interest; and to
Committee Policy contribute to economic development.
Purpose • STAC members are expected to put aside
According to the University of Nebraska individual agendas and seek to work
Board of Regents Patent and Technology for the common good, as they evaluate
Transfer Policy RP-4.4.2 approved in inventions using these criteria.
November 2003, UNMC is required to
establish a Science and Technology • STAC members should attend every
Advisory Committee (STAC) for the review meeting. The date, time and location
of new inventions. Each new invention of meetings will be determined by
is evaluated for the potential to obtain the Patent Administrator. An agenda
effective intellectual property protection, and minutes will be prepared for each
stimulate business interest, and meeting. Written descriptions of the
contribute to economic development. inventions to be discussed will be
STAC makes recommendations based provided to members at least three (3)
upon these criteria to the UNMC days in advance of meetings so that
Patent Administrator and the Vice members of STAC may be prepared for
Chancellor for Research, who have the discussions.
authority for decisions regarding • Information about inventions and
intellectual property development, about discussions at the meeting are
licensing and other technology transfer confidential and not to be shared with
issues. STAC also may be called upon persons outside of STAC. All members and
to make recommendations to the Vice attendees shall execute confidentiality
Chancellor for Research concerning the agreements with the Board of Regents
administration of RP-4.4.2 "Patent and before receiving confidential information.
Technology Transfer Policy" or Section • Any written descriptions of inventions
3.10 of the Bylaws of the Board of distributed outside UNeMed are to be
Regents. returned to UNeMed without having been
Membership copied. Outcomes of the meeting will be
• Members of STAC are selected by relayed to inventors by a representative
the UNMC Patent Administrator in of UNeMed.
consultation with the Vice Chancellor for
Research. UNMC Policy 7001
• Qualifications to be considered for Policy for Royalty and Equity Distribution
appointing members include knowledge, Basis for Policy
experience, enthusiasm and ability. As per RP-4.4.2 Board of Regents Patent
• STAC will be composed of UNeMed and Technology Transfer Policy, the
personnel. Additionally, STAC has within University of Nebraska Medical Center
its purview the ability to utilize the (UNMC) is responsible for allocating
expertise of UNMC faculty and outside non-inventor technology transfer
consultants as ad hoc members of STAC proceeds according to its individual
to review specific technologies. All campus policy. These non-inventor
proceeds consist of two thirds of the
56 UNEMED.COM
royalties and equity received in return University is distributed to University of
for use of University owned intellectual Nebraska inventors.
property rights. Furthermore, Regents When a single source of proceeds
Policy no longer requires that a share of involves multiple University of
proceeds be distributed to the academic/ Nebraska inventors, inventors should
administrative units of inventors. In coordinate with UNeMed to file a
order to best utilize non-inventor written agreement delineating the
proceeds and to serve the objectives of division of proceeds between all
the Regents Policy, UNMC shall allocate inventors. Multiple inventor proceeds
non-inventor proceeds on a case by case received but not adequately covered
basis as determined by the Committee by a written inventor agreement will
for Proceed Distribution. Those academic/ be distributed equally between all
administrative units having a connection University of Nebraska inventors.
to proceeds at issue shall participate to
In some highly meritorious cases a
provide the Committee with information
given inventor may be found to have
addressing their support of the
earned a share of the proceeds that
underlying technology.
exceeds the general recommendation
Membership of one-third; however in no case will
Members of the Committee for a distribution be made to an inventor
Proceed Distribution shall be the Vice that exceeds the recommended
Chancellor for Business and Finance, one-third until the university has
the Vice Chancellor for Research, the recovered 100 percent of its costs, and
Vice Chancellor of Academic Affairs, an appropriate continuing share has
the President of UNeMed, the Patent been determined for the university.
Administrator and one member at large Such decisions are to be considered
to be selected annually by a majority vote highly exceptional and will require
of the other members. The Committee the approval of the President upon
shall meet at least annually to carry out recommendation of the Chancellor. The
the function of RP- 4.4.2, Section 5(b). President shall report such exceptions
Responsibilities to the Board of Regents.
Expenses and Net Proceeds Distribution of Net Proceeds to Non-
inventors
Reviewing the legal fees and other
technology transfer expenses Examining sources of net non-inventor
associated with each source of proceeds covered by the Regents’
proceeds. Regents’ Policy requires that intellectual property policies and
such expenses be reimbursed before determining what proportion, if any,
any proceed distributions are made. should be distributed to inventors’
academic/administrative units. This
To meet this requirement 10% of all
determination shall be in keeping
proceeds received will be set aside
with each unit’s level of support
for the administration of technology
and commitment to technology
transfer. In addition, patent expenses
development. Academic/administrative
and other legal and professional
units found to be without significant
expenses will first be reimbursed from
contribution to technology
gross proceeds.
development may be excluded from
Reviewing general proceed allocations receiving proceeds.
with other organizations and non-
Deans or Directors of the academic/
inventor proceed allocations between
administrative units employing faculty
campuses.
or other persons responsible for
Distribution of Net Proceeds to Inventors creating intellectual property from
Ensuring that with respect to proceeds which net proceeds are generated shall
covered by Regents’ Policies, one third be given notice of Committee meetings
of all net proceeds received by the and provided the opportunity to
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present information representing and regulations while teaching, conducting
significant support of UNMC research or providing service activities
technology development. Ordinary at or on behalf of the university. As such,
support consisting of only the usual personnel are required to comply with the
salary, space, and equipment afforded U.S. laws that regulate the transfer of items,
to faculty shall not be considered information, technology, software, and
significant. Information intended to be funds to destinations and persons outside
representative of significant support of the U.S., as well as in some cases, to non-
to technology development shall be U.S. citizens at the university.
substantiated through documentation, Export controls, set forth in regulations
interviews with inventors, or other administered by several federal agencies,
appropriate means. The Committee impose access, dissemination, and
shall refrain from deciding non- participation restrictions on the transfer
inventor proceed allocations until all and retransfer of "controlled" information
interested principals have been given and on the export and reexport of tangible
reasonable opportunity to participate. items. The United States Department of
Earmarking net proceeds as may be Commerce must issue an export license
distributed to academic/administrative or there must exist an exception to or
units to be used for research beneficial exclusion from license requirements before
to technology development. any controlled tangible item, software or
Allocating any net non-inventor information on the U.S. Commerce Control
proceeds to UNMC accounts for use List (CCL) of the Export Administration
in furthering translational research or Regulations (EAR) may be exported or
otherwise furthering the objectives reexported. Likewise, if a tangible item,
of technology and economic software or information is on the U.S.
development. This includes those net Munitions List (USML), the U.S. State
non-inventor proceeds not distributed Department must issue an export license
to academic/administrative units. or provide for an exception to or exclusion
from licensing requirements.
The allocation and/or earmarking
of net non-inventor proceeds not Export controls restricting a foreign
to be distributed to any academic/ national's participation in university
administrative units shall take the form research within the United States, i.e.,
of a recommendation made to the "deemed export" restrictions, generally do
UNMC Research Resources Board or not apply to the results of fundamental
its functional equivalent. The Research research. Fundamental research conducted
Resources Board shall then confirm outside of the U.S., or subject to specific
or redirect the non-unit distribution U.S. Government access and dissemination
and report the final recommendation controls however, remains subject to export
to UNMC’s Chancellor before such controls.
proceeds are made available. In the case of shipments of certain tangible
Other Responsibilities items, software or information outside the
U.S., UNMC has the responsibility to either:
Performing other responsibilities within
the scope of RP- 4.4.2, Section 5(b). Obtain an export license;
Document an express determination
that an exception to export licensing
UNMC Policy 8005 requirements applies; or
Export Control Policy Document an express determination
All personnel, including faculty, staff, that no license is needed.
research associates and fellows, visiting Definitions
scholars, students, and all other persons
retained by or working at the University of EXPORT: Means to send or take controlled
Nebraska Medical Center and its affiliates tangible items, software or information
will comply with all applicable U.S. laws out of the United States in any manner,
58 UNEMED.COM
to transfer ownership or control of U.S. as well as international organizations,
controlled tangible items, software or foreign governments and any agency
information to a foreign person, or to or subdivision of foreign governments
disclose information about controlled (e.g. diplomatic mission). In determining
items, software or information to a nationality for International Traffic in
foreign government or foreign person. Arms Regulations (ITAR) purposes, the
The controlled tangible item, software or U.S. Department of State, Directorate
information being sent or taken out of of Defense Trade Controls (DDTC) will
the United States is also referred to as an consider country of birth as well as any
"export." country where the person is or was a
REEXPORT: Means an actual shipment or citizen. The U.S. Department of Commerce
transmission of controlled tangible items, considers only the most recent country
software or information from one foreign of citizenship for the purposes of its
country to another foreign country. The “deemed export rule”.
export or reexport of controlled tangible FUNDAMENTAL RESEARCH: The concept of
items, software or information that will "fundamental research" was established
transit through a country or countries, or by National Security Decision Directive
will be unloaded in a country or countries 189. NSDD 189 defines fundamental
for reloading and shipment to a new research as:
country, or are intended for reexport basic and applied research in science
to the new country, are deemed to be and engineering, the results of which
exports to the new country. ordinarily are published and shared
DEEMED EXPORT: Is a term used by the broadly within the scientific community
U.S. Commerce Department to describe as distinguished from proprietary
the situation where a foreign national research and from industrial
on U.S. soil may be exposed through development, design, production, and
visual inspection or oral transmission product utilization, the results of which
of information relating to an export- ordinarily are restricted for proprietary
controlled item or export-controlled or national security reasons.
software or information. NSDD 189 provides that the products
U.S. PERSON/FOREIGN PERSON: A "U.S. and results of fundamental research are
person" is a citizen of United States, a to proceed largely unfettered by deemed
lawful permanent resident alien of the export restrictions. It also states that the
U.S., (a "Green Card" holder), a refugee government must determine - before
or someone here as a protected political releasing a research opportunity -
asylee or under amnesty. U.S. persons whether the research should be classified
also include organizations and entities, or otherwise kept secret. Research
such as universities, incorporated in the that carries access, participation, or
U.S. The general rule is that only U.S. dissemination restrictions will not qualify
persons are eligible to receive controlled as fundamental research for purposes of
items, software or information without the export control regulations.
first obtaining an export license from Applicable Federal Regulations
the appropriate agency unless a license
The export control regulations
exception or exclusion is available.
summarized here each impose severe
A "foreign person" is any natural person monetary and criminal penalties for
who is not a U.S. citizen, lawful permanent failure to comply with their requirements.
resident or who is not a protected
U.S. Department of State - International
individual as defined by 8 USC section
Traffic in Arms Regulations (ITAR) 22
1324b(a)(3). A foreign person also means
CFR 120-130
any corporation, business association,
partnership, trust, society or any other The U.S. Department of State,
entity or group that is not incorporated in Directorate of Defense Trade Controls
the U.S. or organized to do business in the (DDTC), is responsible for items and
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information inherently military in the United States, unless some other
design, purpose, or use. Referred to as agency has expressly been given such
"defense articles," such items are found authority. However, this does not mean
on the U.S. Munitions List (USML), 22 that a license must be obtained before
CFR 121. Spacecraft and satellites, any item or piece of information can be
even if not for military use, are on the shipped. An Export Control Decision Tree
USML, along with their associated is available to assist in determining the
systems and related equipment. applicability of export control regulations
Information related to defense articles in the case of shipments of tangible items
is referred to as "technical data." or transfers or transmission of software
U.S. Department of Commerce - Export code or information outside U.S. borders.
Administration Regulations (EAR) 15 In order to determine whether it is
CFR 730-774 necessary to obtain an export license
The U.S. Department of Commerce, from the relevant federal agency to send
Bureau of Industry and Security (BIS), tangible items or to transfer or transmit
has export jurisdiction over everything software code or information outside the
in the United States, although BIS does United States, the researcher preparing
not require a license for every export. the shipment or transfer needs to
BIS controls goods and information consider:
having both civilian and military • whether the software code or
uses by including them on the Export information is proprietary or disclosure-
Administration Regulations (EAR) restricted and thus possibly export
Commerce Control List (CCL), 15 CFR controlled, or whether it resulted from
774, also known as the "Dual Use List." fundamental research to which export
BIS uses the term "technology" when controls do not apply,
referring to information about the • the description of the tangible item,
goods on the CCL. software or information,
U.S. Department of the Treasury - Office • the technical characteristics and
of Foreign Assets Control (OFAC) 31 CFR specifications of the item, software or
500-599 information,
The U.S. Department of the Treasury • its intended end-use and end-user,
oversees U.S. economic sanctions and
and embargoes through its Office
• its destination.
of Foreign Assets Control (OFAC).
Empowered by the Trading with the All tangible items, software code and
Enemy Act and the International information not on a U.S. export control
Emergency Economic Powers Act, list may be shipped or transmitted to
OFAC enforces trade, anti-terrorism, any country, individual or entity that is
narcotics, human rights and other not sanctioned, embargoed or otherwise
national security and foreign policy restricted for export. Such items, code and
based sanctions prohibiting the information may be exported as EAR99
provision of anything of value, either or as "No License Required" (NLR), with
tangible or intangible, to sanctioned identified Export Control Classification
countries, organizations or individuals. Number (ECCN) and exception.
The pertinent regulations provide Certain overseas shipments or
OFAC with broad authority to block or transmissions being handled on a "No
interdict vaguely defined "prohibited License Required" basis will require an
transactions" involving restricted explanation and justification (ECCN and
destinations or parties. License Exception) for that classification.
Export Licenses for Overseas Shipments For international shipments involving
shipping chemicals, biologicals or other
The U.S. Department of Commerce
dangerous materials, contact UNMC’s
has export jurisdiction over all goods
Chemical Safety Officer and Biosafety
and all "technology" or information in
60 UNEMED.COM
Officer as applicable. • Export Control Decision Tree
Accepting a Third Party's Controlled Items • ITAR Website
or Data • EAR Website
Export-controlled items, software code or • OFAC Website
information provided by a third party may
not be openly shared with certain foreign
nationals, even though those individuals UNMC Policy 8010
may be important contributors to the Conflict of Interest Policy
performance of research. For example, a Basis for Policy
corporate vendor or a research partner Statutes, regulations, University policies
may have to disclose the proprietary and accreditation standards related to
information on a piece of export- conflict of interest identification and
controlled hardware being provided management are:
for use in carrying out a fundamental 1. "Responsibility of Applicants for
research experiment. Proprietary or Promoting Objectivity in Research for
restricted information that is required which Public Health Service Funding is
for the development, production or Sought and Responsible Prospective
use of export-controlled equipment is Contractors" regulations at 42 CFR Part
itself export-controlled. It carries with it 50 and 45 CFR Part 94
export control requirements that must be 2. "Financial Disclosure by Clinical
honored by the researcher who agrees to Investigators" Food & Drug
be a recipient of such information. Administration regulations at 21 CFR
Generally, federal regulations require that Part 54
only U.S. persons may be provided with 3. Nebraska Conflict of Interest Statute
export-controlled items, software code at Neb. Rev. Stat. §49-1493 et. seq.
or information without having to obtain
4. Bylaws of the Board of Regents of the
an export license. Nonetheless, there
University of Nebraska Sections 3.10,
are some specific exemptions (ITAR) and
3.4.5 and 3.8
license exceptions (EAR) available to those
within the University community that 5. Board of Regents Conflict of Interest
may be useful. It is extremely important Policy, RP-3.2.8
to keep them in mind should it become 6. Board of Regents Patent &
necessary to share any export-controlled Technology Policy, RP-4.4.2
items, software code or information 7. UNMC Human Research Protections
beyond the original recipient. Policy #3.12, "Identification and
Additional Information and Resources Management of Potential Financial
• For questions regarding the use of "No Conflicts of Interest of Research
License Required” or license exceptions Personnel"
and exemptions, please contact the 8. UNMC Policy No. 1049, Outside
UNMC Export Control Officer (402-559- Employment
9328)/ITAR Empowered Official (402-559- 9. UNMC Policy No. 8015, Health Care
4518) Vendor Interactions
• For additional information concerning Policy
the applicability of the export control
Potential conflicts of interest arise in a
regulations to any specific set of facts,
variety of circumstances in the academic
questions should be directed to the
health sciences center environment
UNMC Export Control Officer (402-559-
when an individual's private financial
9328)/ITAR Empowered Official (402-559-
interests either conflict with or create
4518)
the appearance of conflicting with
• Inquiries may also be addressed to the UNMC's public interests. This policy
Chief Compliance Officer (402-559-9576 applies to potential conflict of interest
or 402-559-6767). arising in any UNMC activity, including
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but not limited to research, teaching, the University of Nebraska. This includes
patient care, outreach to underserved indirect personal financial interests of a
populations and the associated business Covered Person that may be obtained
activities in support of them. Covered through third parties such as a Covered
Persons shall disclose all financial Person's immediate family, business
interests related to their University of relationships, fiduciary relationships, or
Nebraska responsibilities so that an investments.
analysis of potential conflict of interest Equity includes any stock, stock option, or
may be conducted. When a conflict other ownership interest, as determined
of interest is identified, the conflict through reference to public prices or
will either be managed or eliminated other reasonable measures of fair market
to reduce the appearance of bias and value.
maintain responsible stewardship of
Financial Conflict of Interest (FCOI) under
public resources. This policy shall be
PHS regulations means a Significant
publicly posted in the UNMC Policies and
Financial Interest that the COI Officer or
Procedures manual on the UNMC internet
COI committee reasonably determines
site.
could directly and significantly affect the
Definitions design, conduct or reporting of research.
Covered Person under Regents Policy 3.2.8 Immediate Family under Regents Policy
shall mean: 3.2.8 shall mean an individual who is a
1. University administrative officers and spouse, child, brother, sister, grandchild,
employees, specifically including any or grandparent, by blood, marriage, or
University employees with delegated adoption of the Covered Person.
signature, purchasing or contracting Institutional Conflict of Interest (ICOI) may
authority on behalf of the university; occur when the University or a Covered
2. University employees and faculty Person in a senior administrative position
engaged in outside employment or has a financial interest in a commercial
other activities specified in this policy entity that itself has an interest in a
(tech transfer/use of University facilities University research project, including
or equipment) that may create a potential conflicts with equity/ownership
Conflict of Interest; and interests or royalty arrangements.
3. Sponsored research investigators Institutional Responsibilities means
who participate in sponsored professional responsibilities on behalf
research; and non-sponsored research of the University of Nebraska which may
investigators participating in human include activities such as professional
subjects or animal subjects research. service including patient care, teaching,
Investigator under PHS regulations shall research & research consultation,
mean the project director or principal outreach, administrative, institutional
investigator and any other person, committee membership including service
regardless of title or position, who is on panels such as the Institutional Review
responsible for the design, conduct or Board or Data and Safety Monitoring
reporting of research which may include Boards, and other duties as specified in
graduate students, post-docs, residents, the Covered Person's job description and/
collaborators or consultants. or employment agreement.
Conflict of Interest (COI) under Regents Remuneration includes salary and any
Policy 3.2.8 shall mean situations when payment for services not otherwise
a Covered Person's direct or indirect identified as salary including but not
personal financial interest, (whether or limited to consulting fees, honoraria, and
not the value is readily ascertainable) may paid authorship.
compromise, or have the appearance Senior/Key Personnel means the Project
of compromising, the Covered Person's Director (PD)/Principal Investigator
professional judgment or behavior in (PI) and any other person identified as
carrying out his or her obligations to senior/key personnel in the UNMC grant
62 UNEMED.COM
application, progress report, or any other of Regents policy and state and
report submitted to the PHS by UNMC. federal regulatory requirements;
Significant Financial Interest means a 2. Implement annual disclosure
financial interest of the Investigator requirements for Covered Persons
or his/her Immediate Family Member and monitor to ensure compliance.
that reasonably appears to be related The UNMC electronic Annual
to the Investigator's Institutional Disclosure of Financial Interest form
Responsibilities, and: is incorporated into this policy by
1. If with a publicly traded entity, the reference. The Annual Disclosure
value of any remuneration received of Interest and Application for
from the entity in the twelve months Authorization to Engage in Outside
preceding the disclosure and the value Professional Activity forms are
of any equity interest in the entity as located at: https://unmc.coi-smart.
of the date of the disclosure, when com .
aggregated, exceeds $5,000; 3. Coordinate identified conflict of
2. If with a non-publicly traded entity, interest matters with Sponsored
the value of any remuneration received Programs Administration, UNeMED,
exceeds $5,000 or when a research the Institutional Review Board
Investigator or Immediate Family holds (IRB), the Institutional Animal Care
any equity interest; and Use (IACUC) committee, the
Associate Vice Chancellor, Business
3. Intellectual property rights and
and Finance (for business COI), and
interests upon receipt of income
the Continuing Medical and Nursing
related to such rights and interests,
Education offices as relevant.
excluding income paid by the
Whenever a potential COI involving
University of Nebraska.;
activities with another University
4. For PHS-funded research of Nebraska campus or university
investigators, includes reimbursed affiliated entity is disclosed or
or sponsored travel, excluding travel identified, notify the other campus
that is reimbursed or sponsored by or university affiliated entity COI
a Federal, state, or local government contact and collaboratively review
agency, an Institution of higher and manage the potential COI.
education, an academic teaching
4. COI Education. Provide COI
hospital, a medical center, or a research
education to Covered Persons at
institute affiliated with an Institution of
time of hire, and every four (4)
higher education.
years thereafter, and immediate
Conflict of Interest Management Roles and re-education when there are policy
Responsibilities changes or when investigators fail
COI Officer to comply with the COI policy. For
The UNMC Conflict of Interest Officer investigators conducting Public
shall be responsible for implementing Health Service (PHS) sponsored
the UNMC COI management program. research, education shall be
The COI management program shall completed prior to the expenditure
also include review and approval of of any PHS funds.
the "Application for Authorization to 5. When Covered Persons have
Engage in Outside Professional Activity" significant financial interests related
forms as delegated by the Chancellor to their institutional responsibilities,
with associated management of present information to the COI
conflict of commitment under Regents committee for potential COI
Policy 3.8. and UNMC Policy 1049, management plan creation.
Outside Employment. The COI Officer
6. Report FCOI to PHS. When the
shall:
COI committee has implemented a
1. Ensure UNMC policy meets Board COI management plan for PHS-
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funded research, update the PHS such research. The documented
e-Commons with the FCOI report review shall contain all of the
provided by the COI committee. elements required by the PHS
Provide initial, annual and revised regulations.
FCOI reports, if applicable for both 8. Reporting Bias & Mitigation
UNMC and its subrecipients. Revised Report. If bias is found with the
FCOI reports shall be submitted design, conduct or reporting of PHS-
within 60 days of identification for funded research, the COI Officer shall
new Investigators added to a grant, notify the PHS awarding component
or newly identified FCOIs for existing promptly and submit a Mitigation
investigators. The FCOI report shall Report containing the retrospective
contain the following elements: review information and a description
1. The role and principal duties of of the impact of the bias on the
the conflicted Investigator in the research project and UNMC's plan of
research project; action taken to eliminate or mitigate
2. Conditions of the management the effect of the bias.
plan; 9. If the research is clinical research
3. How the management plan is whose purpose is to evaluate the
designed to safeguard objectivity safety or effectiveness of a drug,
in the research project; medical device, or treatment, the
COI committee shall require the
4. Confirmation of the
Investigator to disclose the FCOI
Investigator's agreement to the
in each public presentation of
management plan;
the results of the research, and
5. How the management plan request an addendum to previously
will be monitored to ensure published presentations, in addition
Investigator compliance; and to any applicable disclosure listed
6. Other information as needed. below in Disclosure of Financial
7. Conduct retrospective Interest.
review. If UNMC identifies a 10. Public Disclosure. Disclose
significant financial interest Financial Conflicts of Interest (FCOI)
that was not disclosed by a of senior/key personnel involved
research Investigator in a timely in Public Health Service funded
manner, or was not reviewed research only as determined by the
by UNMC, the COI officer shall, COI Committee in response to public
within sixty (60) days: review requests within five (5) business days
the significant financial interest of the request as required by PHS
and determine whether it is regulations. These requests shall
related to PHS-funded research. be coordinated with the University
The COI committee shall of Nebraska Records Management
determine whether a financial Officer.
conflict of interest exists, and, 11. Board of Regents Annual
if so, implement an interim Report. Submit the annual Conflict
COI management plan. Within of Interest and Outside Activities
120 days, the COI committee report to the University of Nebraska
shall complete a documented Director of Internal Audit and
retrospective review of the Advisory Services for review by the
research Investigator's activities Board of Regents Audit Committee.
and the PHS-funded research
Covered Persons
project to determine whether any
PHS-funded research conducted 1. Annual Disclosure of Financial
during the period of non- Interest. Individuals covered under
compliance was biased in the this COI policy shall complete a UNMC
design, conduct or reporting of Annual Disclosure of Financial Interest
64 UNEMED.COM
Questionnaire through the UNMC appeal adverse decisions made under

electronic e-Disclosure system annually. this policy to the Vice Chancellor for
Covered Persons shall receive an e-mail Academic Affairs. The appeal shall be in
notification from the Compliance writing and contain a description of the
Department to complete the form. The adverse decision, justification for why
UNMC Disclosure of Financial Interest the decision should be changed, and the
form contains all elements required under change desired. The appeal request shall
Board of Regents policy and federal be submitted to the COI Officer. The VCAA
regulations (including PHS regulations) shall respond in writing to the Covered
and is incorporated into this policy by Person with his/her decision within thirty
reference. The electronic system may (30) days of receipt. The VCAA's decision
be accessed at: https://unmc.coi-smart. is final.
com. Individuals shall disclose all financial COI Committee
interests related to their University of
The UNMC COI Committee composition
Nebraska (institutional) responsibilities.
and operating procedures are contained
2. Research Investigators shall review in Appendix A. The COI Officer shall be a
and update their Annual Disclosure of member of the COI committee and shall
Financial Interest when sponsored grants provide administrative support for the
and contracts are submitted, including committee. The COI committee shall:
PHS-funded research. Investigators
1. Provide oversight over the UNMC COI
shall update their Annual Disclosure
program, advise the COI officer, and
of Financial Interest form within thirty
provide guidance on UNMC COI policy
(30) days of discovering or acquiring a
matters.
Significant Financial Interest and on an
annual basis thereafter during the period 2. Review Significant Financial Interests.
of the award. Review Disclosures of Financial Interest
in the amount of $5,000 and above for
3. Education. Covered Persons shall
research Investigators and determine
complete education on Board of
if these Significant Financial Interests
Regents COI policy, UNMC COI policy,
are related to the research, and, if
and PHS COI regulations, and their
so related, whether the Significant
disclosure responsibilities prior to initially
Financial Interest constitutes a Financial
completing the Annual UNMC Disclosure
Conflict of Interest. A Significant
of Financial Interest, and every four (4)
Financial Interest is a Financial Conflict
years thereafter. Covered Persons shall
of Interest if it could directly and
not spend any PHS research funds until
significantly affect the design, conduct ,
education has been completed.
or reporting of research, including PHS-
4. Disclosure of Financial Interest. Covered funded research.
Persons who are research Investigators
3. Create COI Management Plans for
shall disclose the nature of all financial
Financial Conflicts of Interest.
interests related to their research (e.g.
consulting advisory board, intellectual 4. Conduct retrospective reviews of
property) in all publications and newly identified Significant Financial
presentations and to all UNMC personnel Interests as described in Conduct
involved in the research project, including Retrospective Review above.
students. In human subjects research, 5. Review COI Policy violations and
Investigators shall disclose their financial recommend sanctions, if appropriate,
interests related to the research in the to the Vice Chancellor Academic
informed consent, as required by UNMC Affairs and to the appropriate
HRPP Policy 1.22. UNMC administrator responsible
5. Appeal Rights. Covered Persons may for supervision of the individual(s)
violating the policy.
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Sponsored Programs Administration No employee, officer, or agent may
Sponsored Programs Administration shall: participate in the selection, award, or
administration of a contract supported
1. Notify all research Investigators
by a Federal award or non-federal entity
submitting sponsored grant/contract
if he or she has a real or apparent conflict
proposals to review their Annual
of interest. Such a conflict of interest
Disclosure of Financial Interest form
would arise when the employee, officer,
and update the information as needed.
or agent, any member of his or her
2. Coordinate with the COI Officer immediate family, his or her partner, or an
when Investigators disclose significant organization which employs or is about
financial interests related to the to employ any of the parties indicated
sponsored project to determine if a COI herein, has a financial or other interest in
management plan is required. or a tangible personal benefit from a firm
Subrecipients. Include provisions in PHS- considered for a contract.
funded subrecipient agreements that: Institutional Review Board (IRB)
1. the subrecipient certifies that its FCOI The IRB shall require all Covered Persons
policy complies with PHS regulations listed on the IRB application who have a
or that the subrecipient will follow the financial interest to update their Annual
UNMC COI policy; and Disclosure of Financial Interest form
2. the subrecipient shall report pursuant to UNMC HRPP Policy 1.22. The
identified FCOIs for its Investigators in IRB shall review and approve proposed
a timely manner so UNMC can report COI management plans as described in
identified FCOIs to the PHS in the time HRPP Policy 1.22.
frames in Report FCOI to PHS and UNeMED
Conduct retrospective review above.
The President of UNeMED or designee
Assistant Vice Chancellor, Business and shall coordinate with the COI officer on
Finance UNeMED activities where it appears that
The Assistant Vice Chancellor for Business a Covered Person's or UNMC's financial
and Finance shall manage business interest may be a potential individual or
conflict of interest by reviewing all institutional conflict of interest, including
Annual Disclosure of Financial Interest intellectual property interests and equity
questionnaires completed by Covered interests involving technology transfer
Persons with contract signature authority companies.
under Executive Memorandum 13 and Continuing Education Offices
14; Covered Persons with purchasing
UNMC is accredited by the Accreditation
authority; Covered Persons who identify
Council for Continuing Medical Education
family member(s) with a financial interest
(ACCME). The Continuing Medical
with the University of Nebraska; and
Education (CME) office shall review
any other potential business-related
disclosures of financial interest for UNMC
financial interest identified by the COI
employees who are serving as course
Officer through the annual COI disclosure
directors, faculty or peer reviewers for
process or by any other person at UNMC.
UNMC CME courses, as required by
Business COI management plans shall be
the ACCME Standards for Commercial
created to minimize the appearance of
Support.
bias in decision-making and ensure state
and federal regulations and University Institutional Conflict of Interest
of Nebraska business-related policies Management
are followed. Business COI management In order to avoid real or perceived
plans shall be reported through the favoritism in relationships with
UNMC COI committee and reported on research sponsors, each/every potential
the Annual COI report to the Board of Institutional COI shall be reported. Any
Regents Audit committee. Covered Person who has knowledge of
potential Institutional COI shall report the
66 UNEMED.COM
information to the COI Officer. Potential enumerated."

Institutional COI may be identified Sanctions
through the Annual Disclosure of
Covered Persons who violate this policy
Financial Interest questionnaire for senior
may receive corrective action under
administrative personnel. The COI Officer
UNMC Policy No. 1098, Corrective and
shall convene a group of senior UNMC
Disciplinary Action Policy. The COI
officials appointed by the Chancellor
Committee may also recommend other
to review the disclosure and propose
corrective action such as additional
a management plan for Chancellor
training, or for serious violations,
approval if appropriate. It is important
recommend that research funding
to note that PHS COI regulations do not
be withheld or recommend other
cover institutional conflict of interest.
appropriate sanctions to maintain
Records Retention the integrity of the research. The Vice
All Disclosure of Financial Interest Chancellor of Academic Affairs shall
information, COI management plans and review and approve all proposed
all Public Health Service-funded Financial sanctions. The sanctions shall be
Conflict of Interest-related records shall coordinated with the respective
be retained for the fiscal year in which Dean, Director or Vice Chancellor for
the grant or contract is closed plus enforcement.
seven (7) years as required by Board of
Regents Records Retention Schedule Policy 8010 Appendix A
170-8, "Sponsored Projects (Grants)". No Conflict of Interest Committee (COIC)
destruction of records shall take place if Governance
there is a Preservation Hold in effect, or if
COI Committee Composition. The
any litigation, claim, negotiation, audit or
COI Committee shall have at least 16
other actions involving the records have
members representing the following
been started before the expiration of the
areas:
retention period. The records must be
retained until completion of the action • College of Medicine
and resolution of all issues which arise • Vice Chancellor for Business, Finance
from it, or the seven year retention period, and Business Development
whichever is later, as required under 45 • College of Dentistry
CFR 74.53 and 92.42. • Vice Chancellor for Research
Public Accessibility of PHS-funded Senior/ • College of Pharmacy
Key Personnel FCOI
• Compliance/Conflict of Interest Officer
Upon request, the COI Officer shall make
available to the public information • College of Nursing
concerning identified FCOIs held by • Sponsored Programs Administration
Senior/Key personnel receiving PHS • College of Public Health
research funding as required by PHS • Institutional Review Board
regulations. Information shall be provided
in writing within five (5) business days • Eppley Cancer Institute
of the request. The COI officer shall • Associate General Counsel
coordinate these public requests with • Munroe Meyer Institute
the University of Nebraska Records • Center for Continuing Medical
Management Officer. All other financial Education
interest disclosure information and
conflict of interest determinations • Senior Vice Chancellor for Academic
shall remain confidential and may be Affairs
withheld from the public as permitted • College of Allied Health Professions
under Neb. Rev. Stat. 84-712.05, "Records • Community Member
which may be withheld from the public; Membership Term. COI Committee
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members shall serve for a term of three scheduled COI Committee meeting.
years, which may be automatically Additional Information
renewed upon mutual agreement of
• Contact the Chief Compliance Officer
the member and the Chancellor or his/
her designee. New members shall be • Contact the Assistant Vice Chancellor
nominated by the department/unit for Business and Finance
and approved by the Vice Chancellor of • Conflict of Interest Procedures
Academic Affairs or his/her designee. • Research Conflict of Interest
The Chancellor or his/her designee Procedures
shall appoint a faculty chair of the COI • UNMC Policy No. 1049, Outside
Committee. The Vice Chancellor of Employment
Academic Affairs or his/her designee
shall select the community member. • UNMC Policy No. 8015, Health Care
The Chancellor or his designee can Vendor Interactions
appoint additional voting and non-voting • Application for Authorization to
members. Engage in Outside Professional Activity
Quorum. A quorum is required for • Annual Disclosure of Financial Interest
meetings to be conducted. More than half Questionnaire
of the membership present will constitute • UNMC Statement of Understanding
a quorum. Training Information document
Voting. All committee members are
eligible to vote. No regular motion UNMC Policy 8014
shall pass unless a majority of the COI Disclosing Foreign Support and
Committee members present vote in International Activities
favor of the motion. Definitions
COIC Member Conflicts. If a COIC Foreign Entities include, by way of
member has a conflict of interest with example: foreign governments and
a specific matter being discussed, the agents thereof; foreign colleges,
member shall declare that he/she has a universities, and research institutions;
potential conflict and shall not vote on business associations organized under
the matter. Such conflicts may arise when: or otherwise subject to the laws of
1. the member is participating in the foreign jurisdictions; foreign journals
research under review; and professional organizations.
2. the member has a financial Foreign Individuals include individuals,
relationship with a research sponsor regardless of citizenship, employed
under review; or by or otherwise acting on behalf of a
3. the member has a personal Foreign Entity.
relationship or conflict with the Support(ed) includes any financial or
individual under review that could non-financial support for any aspect of
potentially cause the member to be any activity. Non-financial support may
perceived as less than objective in his/ include exchanges of data or materials;
her review. donations of equipment, software, or
Committee Review by Telephone/ other materials; or payment of travel
Electronically. While face-to-face and related expenses, including meals
meetings will normally be held, and lodging.
committee review of potential conflicts Activities Supported by Foreign Entities
may be conducted by telephone or or Individuals are any activity for which
electronically at the discretion of the COI a Foreign Entity or Foreign Individual
Committee chair. provides financial or non-financial
Meeting Minutes. The Compliance Support, including without limitation:
Manager shall prepare meeting minutes a. Serving as an employee or agent
and present them for approval at the next of a Foreign Entity or Foreign
68 UNEMED.COM
Individual; Establish requirements for disclosing
b. Collaborating in research Support
with a Foreign Entity or Foreign UNMC is committed to building
Individual, including designing partnerships on a global scale. At
experiments, collecting and the same time, federal and state
analyzing data, preparing law and University of Nebraska
manuscripts for presentation or policy require transparency with
other publication, and presenting respect to certain activities and
or otherwise publishing the results relationships involving Foreign
of research; Entities or Foreign Individuals.
c. Providing consulting services The purpose of this policy is
to a Foreign Entity or Foreign to establish requirements for
Individual, whether or not such disclosing Support received
services are compensated; from Foreign Entities or Foreign
Individuals by UNMC personnel.
d. Developing partnerships or
other business relationships Supplement and clarify existing policy
with a Foreign Entity or Foreign This policy is designed to
Individual; supplement and clarify existing
e. Accepting gifts, including University of Nebraska and UNMC
donations of funding, policies on reporting conflicts
accommodations, travel-related of interest and commitment
expenses, equipment, software, involving Foreign Entities or Foreign
or any materials to be used in Individuals, and does not replace or
support of research or clinical supersede disclosure requirements
activities, from a Foreign Entity or imposed by federal or state law
Foreign Individual; and or other University of Nebraska or
UNMC policies, including those listed
f. Any other activity or relationship
above.
subject to a disclosure
requirement under University of Statement of Policy
Nebraska policy or state or federal Disclose nature of Support
law that involves a Foreign Entity All UNMC personnel who receive
or Foreign Individual. Support from a Foreign Entity or
UNMC Personnel include, for the Foreign Individual must disclose the
purposes of this policy: nature of the Support in accordance
a. Faculty; with RP 3.2.8 and UNMC Policy No.
8010. Additionally, UNMC personnel
b. Staff;
engaging in research must make
c. Students; such disclosures prior to or while
d. Volunteers; applying for federal research funding
e. Visitors; and or participating in federally funded
f. Any other individuals who research. In no event will any federal
participate in any activity on funds be spent or committed until
behalf of UNMC, irrespective of all disclosure requirements related
appointment, compensation, or to Support from a Foreign Entity
the location of the activity. or Foreign Individual have been
fulfilled.
Scope
Obtain permission from Vice Chancellor
This policy applies to all UNMC for Business and Finance
Personnel, irrespective of appointment,
compensation, or the location of the All UNMC Personnel who wish
activity. to establish a clinical practice or
for-profit or non-profit business
Purpose outside the United States must
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obtain permission from UNMC’s Vice Additional Information
Chancellor for Business and Finance • Contact the Chief Compliance Officer
prior to establishing the practice or
• Contact the Export Control Director
business.
• Department of Energy Order 486.1,
Obtain permission from Vice Chancellor
Department of Energy Foreign
for Research
Government Talent Recruitment
All UNMC Personnel who wish to Programs
establish a research laboratory outside
• NIH Notice No. NOT-OD-19-114
the United States, or to engage in
research physically located at a foreign • White House Office of Science and
institution, must obtain permission Technology Policy Letter to the United
from UNMC’s Vice Chancellor for States Research Community (Sept. 16,
Research prior to commencing the 2019) (“Policy Letter”)
conduct of such research. • NSF Letter 19-200
Disclosure Requirements
Comply with UNMC Policy No. 8010
Activities Supported by Foreign Entities
or Individuals must be disclosed using
the mechanisms for conflict of interest
assessment prescribed in UNMC Policy
No. 8010. Disclosures of Activities
Supported by Foreign Entities or
Individuals are subject to review by the
relevant academic program leader, the
Chief Compliance Officer, the Export
Control Director, and other UNMC
officials as appropriate.
Comply with any funding organization
disclosure requirements
When applying for external research
funding, UNMC personnel must
also comply with any disclosure
requirements imposed by the funding
organization. In many cases, this may
require making separate disclosures to
UNMC in addition to any disclosures
required by the external funding
organization.
Violations
Failure to comply with this policy will
result in corrective or disciplinary
action as provided under UNMC
Policy No. 1098, Corrective/
Disciplinary Action, including
termination, dismissal, or exclusion
from participation in federally funded
activities.
70 UNEMED.COM
APPENDIX II
GLOSSARY OF TERMS
article of manufacture One of four any resulting revenues with the
principal categories of things that inventors.
may be patented in United States
patent law. The other three are a commercialization The application
process (or method), a machine, of business methods as a way
and a composition of matter. to advance a new technology to
The Supreme Court has defined market.
"manufacture" as "the production
of articles for use from raw or composition of matter One of four
prepared materials by giving to principal categories of things that
these materials new forms, qualities, may be patented in United States
properties, or combinations, patent law. The other three are a
whether by hand-labor or by process (or method), a machine,
machinery." Examples of articles and an article of manufacture.
of manufacture are ceramics, cast The Supreme Court has defined
metal articles, hammers, crowbars, "composition of matter" to mean
chairs, shovels, gloves, shoes, "all compositions of two or more
envelopes and mouse-pads. Articles substances and all composite
of manufacture may have parts, but articles, whether they be the results
any interaction among the parts of chemical union, or of mechanical
is usually static. A natural article, mixture, or whether they be gases,
even if subjected to a process, is not fluids, powders or solids." (Source:
an article of manufacture. (Source: Wikipedia)
Wikipedia) confidential disclosure
assignment Legal transfer of a agreement (CDA) A legal contract
claim, right or property. between at least two parties that
outlines confidential material,
AUTM Association of University knowledge, or information that
Technology Managers was founded the parties wish to share with
in 1974 as the Society of University one another for certain purposes,
Patent Administrators to address but wish to restrict access to or
a concern that inventions funded by third parties. Also known as a
by the U.S. government were not nondisclosure agreement (NDA),
being commercialized effectively. it is a contract through which
AUTM now provides professional the parties agree not to disclose
development and networking information covered by the
opportunities for technology agreement. The contract creates a
transfer professionals and from confidential relationship between
similar organizations worldwide. the parties, typically to protect any
type of confidential and proprietary
Bayh-Dole Act Passed in1980, information or trade secrets.
provides ownership rights to
universities and other non-profit continuation A patent application
institutions for discoveries resulting that allows an inventor to expand
from federally funded research, the claims or scope of a previous
provided certain obligations are met. or "parent" patent application
Obligations include efforts to protect while using the same description
and commercialize the discoveries; and priority date of the orginal.
submitting progress reports to the Continuations are sometimes used
funding agency; giving preference to to expand the coverage of patent
small businesses that demonstrate claims, reduce overall costs or buy
sufficient capability; and sharing more time for additional research.
UNEMED.COM
APPENDIX II: GLOSSARY

copyright A form of intellectual on the market, resources required for
property protection for expressions further development, and potential
of creative works. Common competition from other products or
examples of copyrights include technologies.
books, music, movies, photos and
artworks. inventor A person who contributed
something in the way of an idea,
declarations The part of a U.S. concept or feature on an invention
patent application where the that is included in a patent
inventor asserts that they are the application.
original inventor, that they've read
and understand the application and license agreement A contract
promise to disclose any relevant describing the rights and
information to the Patent Office. responsibilities related to the use
and exploitation of intellectual
disclosure Any description of an property. Usually, a UNeMed licensee
invention that that would sufficiently is obligated to develop a technology
enable the audience to recreate the and ultimately bring it to market in
invention. An enabling disclosure return for a royalty on net sales.
could be conversation at a dinner
party, publishling a paper or poster, machine One of four principal
a grant application or delivering an categories of things that may be
open seminar or even an email. patented in United States patent
law. The other three are a process (or
discovery The act of being the method), an article of manufacture,
first to find, know about or see and a composition of matter. The
something. Discoveries of laws of Supreme Court has defined the
nature are not patentable and do term "machine" as "a concrete thing,
not have intellectual property rights. consisting of parts, or of certain
devices and combination of devices."
innovation The creation of This "includes every mechanical
something new that improves an device or combination of mechanical
existing process, product or service. powers and devices to perform
some function and produce a certain
intellectual property Inventions effect or result." The parts must
or material that may be protected interact (usually dynamically) with
under patent, trademark, trade one another, otherwise they might
secret or copyright laws. be parts of an article of manufacture.
inter-institutional agreement Examples of machines are steam
Terms under which two or more engines, sewing machines, and TV
institutions will collaborate to assess, sets. Electronic circuits have usually
protect, market, license, and share in been considered machines, although
the revenues received from licensing they may lack moving parts. (Source:
jointly owned intellectual property. Wikipedia)
invention Any new and useful material transfer agreement

process, machine, composition of (MTA) Terms under which faculty,
matter, article of manufacture, or any students and staff at the University
improvement of those things. of Nebraska may share materials
with outside entities, such as
invention evaluation An research collaborators.
examination of an invention's
novelty, protectability, marketability, method See "process"
market size and growth potential,
related intellectual property already
72 UNEMED.COM

milestone A target of achievment patent attorney A lawyer who
set forth in a license agreement that has passed the U.S. Patent and
creates incentives to meet timelines Trademark Office patent bar exam,
and performace goals while also and is legally qualified to represent
setting conditions for penalties upon clients in court regarding intellectual
failure to meet those goals. property. Patent attorneys can also
draft contracts as well as perform the
new invention notification (NIN) same functions as patent agents.
A written description of an invention
that creates a dated record and patent claims Describe specifically
provides information from which the the "metes and bounds" of a
patent and commercial potential can patented invention. The full scope
be evaluated. of the invention is limited to what is
covered in the claims.
nondisclosure agreement See
"confidential disclosure agreement" Patent Cooperation Treaty (PCT)
An international treaty that makes it
non-obvious One of five possible to file for patent protection
requirements for patentability of in more than 150 foreign patent
an invention under U.S. patent law. offices with a single application.
Non-obviousness is the subjective
determination that an invention patent examiner A federal
was an unpredictable and unique employee at the USPTO who
combination of existing inventions, if determines whether or not a patent
any such combining elements exist. can be granted.
The other four patent requirements
are that an invention be comprised patent prosecution The patent
of eligble subject matter, be useful, application process of drafting,
be novel, and be adequately filing and negotiating with the U.S.
described. Patent and Trademark Office. This
does not include litigation, which is
office action A patent examiner's only possible after a patent has been
summary of findings regarding the issued.
allowability of the inventor's claims
in a patent application. prior art Any evidence that an
invention is already known.
option agreement A description of
the conditions under which UNeMed process One of four principal
preserves the opportunity for a categories of things that may be
company to negotiate a license for patented in United States patent
intellectual property. Options are law. The other three are an article
often used with companies who of manufacture, a machine, and a
wish to evaluate a technology before composition of matter. A process
entering a full license agreement. is a series of steps for performing
a function or accomplishing a
patent agent A person who has result. While the terms "method"
passed the rigorous U.S. Patent and and "process" are largely
Trademark Office patent bar exam, interchangeable, "method" usually
and can legally work on, file and refers to a way to use a product
initiate patent applications. Unlike a to accomplish a given result, and
patent attorney, however, a patent "process" usually refers to a series
agent may not draft contracts of steps in manufacture. Thus, one
or advise clients about potential might speak about a method for
courtroom proceedings. curing headaches that comprises the
UNEMED.COM

administration of a therapeutically SPA also reviews and approves
effective dose of aspirin or speak budgets and applications to external
about a process for making soap or sponsors, and tracks pending and
candles. (Source: Wikipedia) future funded projects.
protection Tools used to guard an sponsored research agreement

invention or intellectual property The terms under which sponsors—
from theft or appropriation. such as a pharmaceutical firm or
Tools include patents, copyright, a medical device manufacturer—
trademark, trade secrets and provide support for additional
contractual use restrictions. research at the University.
provisional patent application A startup A newly established

simplified patent application that business.
preserves patent rights, without the
need of listing claims. Provisional technology transfer The process
application are not examined during of protecting and moving an
the one-year they are pending, invention as a concept or early-
which allows inventors to do stage technology in academia to a
things like collect more data, refine tangible product or process that is
a prototype or produce a more available on the open market.
complete patent application.
trade secret Confidential strategies
rights, exclusive Grants only the or information that give their users
licensee, and no one else, the right a competitive advantage. Examples
to use, make or sell a protected of trade secrets are the recipes
intellectual property. for Coca-Cola and Kentucky Fried
Chicken.
rights, non-exclusive Grants the
licensee the right to use, make or sell trademark Any work, name,
a protected intellectual property, but symbol, device, or combination
UNeMed may still grant similar rights that is used in commerce to identify
for the same intellectual property to and distinguish the goods of one
any number of other entities. manufacturer or seller from those
manufactured or sold by others.
royalty sharing agreement
A formal document signed by USPTO United States Patent &
each inventor of one or more Trademark Office.
technologies included in a license.
The agreement spells out exactly utility patent One of three patent
how inventor proceeds from the types available through the U.S.
license will be distributed between Patent and Trademark Office. Utility
the inventors. patents are the most common type,
conferred to inventions that are
royalty Payment made for the right machines, articles of manufacture,
to use an intellectual property. compositions of matter or processes
that are novel, non-obvious, and
Sponsored Program useful. The other patent types are
Administration (SPA) Assists UNMC design patents, which protect the
faculty and administration with way things look, and plant patents,
negotiating terms for governemnt which protect new varieties of
and non-profit grants and contracts. asexually produced plants.
74 UNEMED.COM
NOTES:
UNEMED.COM
NOTES:
76 UNEMED.COM
NOTES:
UNEMED.COM
NOTES:
78 UNEMED.COM
986099 Nebraska Medical Center
Omaha, NE 68198-6099
Telephone: 402-559-2468
unemed@unmc.edu
www.unemed.com
(November 2020)

Inventor's Guide To Technology Transfer

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Inventor's Guide To Technology Transfer

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The Inventor’s Guide to Technology

Transfer outlines the essential

Appendix II: Glossary . . . . . . . . . . . . . . . . . . . . 69

TECHNOLOGY TRANSFER OVERVIEW

Protect first, then publish

What is the Bayh-Dole Act?

TECHNOLOGY TRANSFER OVERVIEW

TECHNOLOGY TRANSFER OVERVIEW

TECHNOLOGY TRANSFER PROCESS

When research becomes an invention

TECHNOLOGY TRANSFER PROCESS: INNOVATION

Research tools Student inventors

TECHNOLOGY TRANSFER PROCESS

New Invention Notifications

Submitting a new invention

TECHNOLOGY TRANSFER PROCESS: DISCLOSURE

TECHNOLOGY TRANSFER PROCESS

After submitting a NIN...

TECHNOLOGY TRANSFER PROCESS: EVALUATION

More research needed: When an invention needs

TECHNOLOGY TRANSFER PROCESS

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

receives the benefit of the would have to secure a patent in

TECHNOLOGY TRANSFER PROCESS: PROTECTION

Proper copyright notices

TECHNOLOGY TRANSFER PROCESS: PROTECTION

TECHNOLOGY TRANSFER PROCESS: PROTECTION

Fried Chicken. Trade secrets high cost of patent fees into

University of Nebraska policy

TECHNOLOGY TRANSFER PROCESS

TECHNOLOGY TRANSFER PROCESS: MARKETING

technology champions within

TECHNOLOGY TRANSFER PROCESS

TECHNOLOGY TRANSFER PROCESS: LICENSING

One example of a licensed

TECHNOLOGY TRANSFER PROCESS: LICENSING

UNeMed license agreements generally include:

TECHNOLOGY TRANSFER PROCESS

The commercialization process

TECHNOLOGY TRANSFER PROCESS: COMMERCIALIZATION

Sponsored Research Agreements: Partners help development

Material Transfer Agreements: Sharing intellectual property & tools

Confidential Disclosure Agreements: An added layer of protection

Inter-Institutional Agreements: Set ground rules for collaborations

Option Agreements: Industrial test drive

Royalty Sharing Agreements: Splitting proceeds

Consulting Agreements: To each their own

Conflict of Interest seek guidance from the Sponsored

should be submitted to the Associate

It doesn’t happen often, but innovations. But those same

UNeMed staff has significant involvement of any kind is also

One example of a successful

Complete a business plan or the innovation. That is an

Questionnaire through the UNMC appeal adverse decisions made under

information to the COI Officer. Potential enumerated."

APPENDIX II: GLOSSARY

invention Any new and useful material transfer agreement