Inventor Guide 2013

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Inventors Guideto Technology Transfer

University of Nebraska Medical Center
http://www.unemed.com/


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The Inventors Guide to TechnologyTransfer outlines the essentialelements of technology transferat the University of NebraskaMedical Center.

This guide is organized to answerthe most common questions that

UNeMed, the technology transferarm of UNMC, typically fields fromthe UNMC research communityand provides a broad overview ofthe technology transfer process andservices available for researchers.

Useful and new information can befound at www.unemed.com, or,if you have specific questions callUNeMed directly at(402) 559-2468 or email us [email protected].
http://www.unemed.com/http://www.unemed.com/


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TABLE OF

CONTENTS

Technology Transfer Overview 1

Technology Transfer Process 3

10 Steps to Commercialization 5

Research Considerations 8

New Invention Notifications (NINs) 10

Ownership of Intellectual Property 12

Assessment of a NIN 14

Patents and Other Legal Protections 15

Marketing to Find a Licensee 21

Considerations for a Start-up Company 23

License Agreements 25

Commercialization 27

Navigating Conflict of Interest 28

Revenue Distributions 29

Laboratory Notebook Guidelines 30

Notes 32


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PAGE 1

What is technology transfer?

Technology transfer is the transferof knowledge and discoveries tothe public. It can occur throughpublications, educated studentsentering the workforce, exchangesat conferences, and relationshipswith industry, among other things.For the purposes of this guide,technology transfer refers to theformal licensing of technology tothird parties under the guidanceof professionals employed byuniversities, research foundations,and businesses.

What is UNeMed?

UNeMed is a for-profit corporationowned by the Board of Regentsof the University of Nebraskathat is responsible for a spectrumof technology transfer activitiesincluding protecting, marketingand commercializing UNMC

inventions.

Why would a researcher wantto participate in the technologytransfer process?

One main reason is to have thesatisfaction of knowing that their

scientific research can lead tothe development of a commercialproduct that would benefithumankind, other reasons mayinclude:

Making a positive impact onsociety

Feeling a sense of personalfulfillment

Achieving recognition and

financial rewardsGenerating additional lab/departmental fundingMeeting the obligations of aresearch contractAttracting research sponsorsCreating educationalopportunities for studentsLinking students to future jobopportunities

How is technology transferred?

Technology is typically transferredthrough a license agreement, inwhich the University grants its rights

in the defined technology to a thirdparty for a specified period oftime, often limited to a particularfield of use and/or region of theworld. The licensee (the third partylicensing the technology) may bean established company or a newstart-up (that may be founded by

the researcher). Licenses includeterms that require the licenseeto meet certain performancerequirements and to make financialpayments to the University.These payments are sharedwith the inventors and are alsodistributed to the schools/colleges,

departments/units, and centraladministration to provide supportfor further research, education,and participation in the technologytransfer process.

TECHNOLOGY TRANSFER

OVERVIEW


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What is the Bayh-Dole Act?

The United States Bayh-Dole Actof 1980 allows universities andother non-profit institutions to haveownership rights to discoveriesresulting from federally fundedresearch, provided certain obligationsare met. These obligations includemaking efforts to protect (whenappropriate) and commercializethe discoveries, submitting progressreports to the funding agency, givingpreference to small businesses thatdemonstrate sufficient capability, andsharing any resulting revenues withthe inventors. The Bayh-Dole Act is

credited with stimulating interest intechnology transfer activities andgenerating increased research,commercialization, educationalopportunities, and economicdevelopment in the United States.

A critically important

requirement of a world-

class medical center is

our effort to create and

commercialize research that

improves healthcare

-Chancellor Harold M. Maurer, M.D.


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PAGE 3

How do I work with UNeMed?

We encourage you to contactUNeMed during your early researchactivities to be aware of the optionsthat will best leverage the commercialpotential of your research. UNeMedstaff are trained to assist you withquestions related to marketability,

commercial partners, patenting andother protection methods, new start-up considerations, University policiesand procedures, and much more.

Our team approach provides youwith an assigned licensing associatesupported by additional expertisein areas such as contracts andintellectual property (IP).

What are the typical steps in theprocess?

The process of technology transfer issummarized in the steps and diagramthat follow. Note that these steps canvary in sequence and often occursimultaneously.

TECHNOLOGY TRANSFER

PROCESS


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PAGE 4

Reinvest in Research and Education

Marketing to find orform a licensee

Invention Disclosure

Research

TECHNOLOGY TRANSFER PROCESS

Revenue

Commercialization

Licensing

Form Start-up

Existing Business

Pre-Disclosure

Assessment

Protection


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10 STEPS TO

COMMERCIALIZATION

1RESEARCH:Observations andexperiments duringresearch activities oftenlead to discoveries andinventions. An inventionis any useful process,machine, compositionof matter, or any newor useful improvementof the same. Often,multiple researchersmay have contributed tothe invention. (Note: Toprotect new inventionsit is critically importantthat research is properly

documented in alaboratory notebook;following the guidelinesprovided on page 31.)

2PRE-DISCLOSURE:An early contactwith UNeMedpersonnel to discussyour invention andto provide guidancewith respect to thedisclosure, evaluation,and protection,processes described

below.

3NEW INVENTIONNOTIFICATION(NIN):The writtennotice of invention toUNeMed that beginsthe formal technologytransfer process. ANIN is confidential andshould fully documentyour invention sothat the options forcommercializationcan be evaluated andpursued.

4ASSESSMENT:The period in whichyour UNeMed licensingassociate reviews theNIN, conducts patentor other IP searches,

and analyzes themarket and competitivetechnologies todetermine the inventionscommercializationpotential. Thisevaluation process,which may lead to

a broadening orrefinement of theinvention will guide ourstrategy on whether tofocus on licensing toan existing company orcreating a new start-up.

5

PROTECTION:Patent protection,

a common legalprotection method,begins with the filingof a patent applicationwith the U.S. PatentOffice and, whenappropriate, foreignpatent offices. Once

a patent applicationhas been filed, it willtypically require severalyears and tens ofthousands of dollars toobtain issued U.S. andforeign patents. Otherprotection methods

include copyright,trademark, tradesecrets, and contractualuse restrictions (e.g.,for databases andmaterials.)


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9COMMERCIALIZATION:The licensee continuesthe advancement of thetechnology and makesother business investmentsto develop the productor service. This step may

entail further development,regulatory approvals, salesand marketing support,training, and other activities.

10REVENUE:A Portion of revenuesreceived by UNeMed fromlicenses are distributed toinventors according to Boardof Regents Policy, and theremainder is invested to fundadditional research andeducation and to encouragefurther participation in thetechnology transfer process.

6MARKETING:UNeMed staffidentifies candidatecompanies thathave the expertise,resources, andbusiness networks to

bring the technologyto market. This mayinvolve partneringwith an existingcompany or forminga start-up. Your activeinvolvement candramatically shortenthis process.

7aEXISTINGBUSINESS:If one or moreappropriate andinterested existingcompanies are

selected as apotential licensee,UNeMed workswith those potentiallicensees to developthe appropriatefinancial anddiligence terms to

fully commercializethe technology.

7bFORM ASTART-UP:If creation of anew start-up hasbeen chosenas the optimalcommercialization

path, foundersmust provide anacceptable businessplan before a licenseis executed.

8

LICENSING:A license

agreement is acontract between theUniversity, UNeMedand a third party inwhich the Universitysrights to a technologyare licensed (withoutrelinquishing

ownership) forfinancial and otherbenefits. A licenseagreement is usedwith both a newstart-up or with anestablished company.An option agreement

is sometimes usedto enable a thirdparty to evaluatethe technology for alimited time prior tomaking a decisionabout licensing.


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How long does the technologytransfer process take?

The process of protecting thetechnology and finding the rightlicensing partner may take months--- or even years --- to complete. Theamount of time will depend on thedevelopment stage of the technology,the market for the technology,competing technologies, the amountof work needed to bring a newconcept to market-ready status, andthe resources and willingness of thelicensees and the inventors.

How can I help in this process?

Call UNeMed at (402) 559-2468 when you believe youhave created or discoveredsomething unique with potentialcommercial or research value.

Complete and submit the NINform (www.unemed.com)beforepublicly disclosingyour invention or submittinga manuscript for review andpublication.

To avoid risking your patent

rights and possibly hinderingthe opportunity to marketyour invention, contactUNeMed beforeany formof public disclosure (seminars,publications, grants, abstracts,posters, etc.). You must avoid

public disclosures or your patentrights can be lost. Fortunately,simple steps, that typically takeless than a week, can protectyour invention before you publishabstracts, manuscripts, or presentat meetings. Call your licensingspecialist before a publicdisclosure. We will repeat thisadvice again, and again.

On the NIN Form, includecompanies and contracts youbelieve might be interestedin your invention or who mayhave already contacted youabout your invention. Studies

have shown that over 70% ofall licenses are executed withcommercial entities known by theinventor, so your contacts can beextremely useful.

Respond to UNeMed andoutside patent counsel requests.

While some aspects of thepatent and licensing processmay require significantparticipation on your part, wewill strive to make efficient use ofyour valuable time.

Keep UNeMed informed of

upcoming publications orinteractions with companiesrelated to your IP.


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RESEARCH CONSIDERATIONSAND MATERIAL TRANSFER AGREEMENTS

Will I be able to publish the resultsof my research and still protect the

commercial value of my IP?

Yes, but since patent rights areaffected by these activities, it isessential to submit a NIN (discussedin next section) well before a publicdisclosure. There are significantdifferences between the U.S. and

other countries as to how earlypublication affects a potential patent.Once publicly disclosed (published orpresented in some form), an inventionmay have restricted or minimalpotential for patent protection outsideof the United States. Be sure to informyour UNeMed licensing associate of

any imminent or prior presentation,lecture, poster, abstract, websitedescription, research

proposal submission, thesis, grantsubmission, publication, or other

public presentation including theinvention.

May I use materials or IP fromothers in my research?

Yes, but it is important to document

carefully the date and conditions ofuse so that we can determine if thisuse may influence the ownership ofyour subsequent research results. Ifyou wish to obtain materials fromoutside collaborators, an incomingMaterial Transfer Agreement (MTA)should be completed. Contact

UNeMed at (402) 559-2468or [email protected] for moreinformation on incoming MTAs.


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Will I be able to share materials,research tools or intellectual

property with others to further theirresearch?

Yes. However, it is important todocument items that are to be sharedwith others and the conditions ofuse. If you wish to send materials toan outside collaborator, an outgoing

MTA should be completed for thispurpose. It also may be necessaryto have a Confidential DisclosureAgreement (CDA) completed toprotect your research results or IP.Contact UNeMed at (402) 559-2468 or [email protected] tocomplete outgoing MTAs or CDAs.

What rights does a researchsponsor have to any discoveriesassociated with my research?

A Sponsored Research Agreement(SRA) should specify the IP rights ofthe sponsor. The University generallyretains ownership of the patent rightsand other IP resulting from sponsoredresearch. However, the sponsor mayhave rights to obtain a license tothe defined and expected outcomesof the research. Often, sponsoredresearch contracts allow the sponsora limited time to negotiate a license

for any patent or IP rights developedas the result of the research.

Even so, the sponsor generallywill not have contractual rights to

discoveries that are clearly outside ofthe scope of the research. Therefore,it is important to define the scope ofwork within a research agreement.

What about consulting?

When researchers enter intoconsulting agreements, they aredeemed to be acting outside ofthe scope of their employment.Therefore, consulting arrangementsare not negotiated by the Universitynor formally reviewed by UNeMedor UNMC. Researchers who enter

into consulting agreements shouldfamiliarize themselves with the Boardof Regents and UNMC policiesrelevant to consulting activities. Theresearcher is expected to ensurethat the terms of the consultingarrangement are consistent withUniversity policies, includingthose related to IP ownership,employment responsibilities anduse of IP. UNeMed is available toprovide informal advice on howyour consulting agreement relatesto your UNMC IP. Be careful not toadvertently give up your IP rights byoverly broad agreements.


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PAGE 10

What is a NIN?

A NIN is a written description ofyour invention or development thatis provided to UNeMed. The NINshould list all collaborating sourcesof support and include all of theinformation necessary to begin

pursuing protection, marketing, andcommercialization activities.

Based on your NIN, UNeMedmay generate a non-confidentialdescription of your invention toassist in marketing the technology.Once potential partners have beenidentified, and CDAs have beensigned, more detailed exchanges ofinformation can be made.

Why should I submit a NIN?

There are at least three reasonsto submit a NIN. First, if you are

an employee of the University ofNebraska, it is required under theterms of your employment. Second,if theresearch was conducted usingfederal funds, investigators arerequired to report inventions tothe University, and we, in turn,

are required to report to thegovernment (failure to do so canactually jeopardize future federalfunding). Finally, disclosure startsa process that could lead tothe commercialization of yourtechnology. This may involvebeginning the legal protectionprocess and working to identifyoutside development partners.

How do I know if my discovery isan invention?

One good measure is if you havea research finding or development

that you feel may solve a significantproblem. Or, perhaps it is somethingtotally novel and not yet in theliterature. If you are in doubt, contactUNeMed to discuss the inventionand strategies for commercialization.

NEW INVENTION

NOTIFICATIONS


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When should I complete a NIN?You should complete a NINwhenever you feel you havediscovered something unique withpossible commercial value. Thisshould be done well beforepresenting the discovery throughpublications, poster sessions,conferences, press releases, orother communications. Oncepublicly disclosed (i.e., published orpresented in some form), an inventionmay have restricted or minimalpotential for patent protection outsideof the United States. Differences existbetween the United States and other

countries concerning the impact ofearly publications on a potentialpatent. Be sure to inform UNeMed ofany imminent or prior presentation,lecture, poster, abstract, websitedescription, research proposal,thesis, publication, or other publicpresentation including the invention.

Should I report research tools toUNeMed?

Yes, if your new tools would benefitother researchers and you areinterested in providing them to

those researchers and other thirdparties. Typically, research tools arematerials such as antibodies, vectors,plasmids, cell lines, mice, and otherbiological materials used as tools inthe research process. Most researchtools do not necessarily need to be

protected by patents to be licensedto commercial third parties and/orgenerate revenue for your laboratory.If you have research tools that youbelieve to bevaluable or wish to provide to others(including researchcollaborators), UNeMed will workwith you to develop the appropriateprotection, licensing, and distributionstrategy.

How do I submit a NIN?

You can download the NIN formand simple instructions from

www.unemed.com. Submit NINs toUNeMed at zip code 6099 or [email protected]. If you have anyquestions, call UNeMed at(402) 559-2468.


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OWNERSHIPOF INTELLECTUAL PROPERTY

What is Intellectual Property?

IP is inventions and/or material thatmay be protected under the patent,trademark and/or copyright laws.

Who owns what I create?

Ownership depends upon theemployment status of the creatorsof the invention and their use ofUniversity facilities. Considerationsinclude:

What is the source of the fundsor resources used to produce theinvention?

What was the employment statusof the creators at the time the IPwas made?

What are the terms of anyagreement related to the creationof the IP?

As a general rule, the Board ofRegents owns inventions made byUniversity of Nebraska employeesacting within the scope of theiremployment or using Universityresources. In some cases, the termsof a SRA or MTA may impactownership. When in doubt, it is best

to call UNeMed for advice.


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What is the University of Nebras-kas policy on ownership of inven-tions?

The Board of Regents Bylaw 3.10and policies 4.4.1 and 4.4.2address the University of Nebraskaspolicies regarding IP ownership and

technology transfer. These regulationsare available at: http://nebraska.edu/board/bylaws-policies-and-rules.html.

Who owns rights to discoveriesmade while I am consulting?

The ownership of inventions madewhile consulting for an outsidecompany depends on the termsof your consulting contract. It isimportant to clearly define thescope of work within consultingcontracts to minimize any issues withownership of inventions created for

University research. Dont engagein unprotected consulting, and ifyou have questions, UNeMed isavailable for informal advice.

Should I list visiting scientists orscientists at other institutions on my

NIN?

All contributors to the ideas leadingto a discovery should be mentionedin your disclosure, even if theyare not University of Nebraskaemployees. UNeMed, along with

legal counsel, will determine therights of such persons and institutions.It is prudent to discuss with UNeMedall working relationships (preferablybefore they begin) to understandthe implications for any subsequentinventions.

Can a student contribute to aninvention?

Yes, many students work oninventions at UNMC under awide variety of circumstances. TheUniversity of Nebraska promotesstudent entrepreneurism, and students

can be named as inventors under theBoard of Regents Policies. The Boardof Regents policies indicate studentinventors are subject to the samerules and receive the same benefitsas University employee inventors.


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How does UNeMed assess NINs?

UNeMed licensing associatesexamine each NIN to review thenovelty of the invention, protectabilityand marketability of potentialproducts or services, relationship torelated IP, size and growth potentialof the relevant market, amount oftime and money required for further

development, pre-existing rightsassociated with the IP, and potentialcompetition from other products/technologies. This assessment mayalso include consideration of whetherthe IP can be the basis for a newstart-up.

What happens if UNeMed decidesnot to protect an invention?

If UNeMed decides not to pursuepatent protection and/or chooses notto actively market the invention, theinventors may request a license from

UNeMed to protect/commercializethe invention themselves. Sucha license may include favorableterms; however it would be limitedto the current invention (not futureimprovements).

ASSESSMENTOF A NIN


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PATENTSAND OTHER LEGAL PROTECTION

What is a patent?

In the U.S., a patent gives theholder the right to exclude othersfrom making, using, selling,offering to sell, and importing thepatented invention. A patent doesnot necessarily provide the holderany affirmative right to practice aninvention since it may fall under a

broader patent owned by others.Instead, it provides the right toexclude others from practicing theinvention. Patent claims are the legaldefinition of an inventors protectableinvention.

What type of subject matter can bepatented?

Patentable subject matter includesprocesses, machines, compositionsof matter, articles, some computerprograms, and methods (includingmethods of making compositions,methods of making articles, andeven methods of performingbusiness).

Can someone patent a naturallyoccurring substance?

No, unless some underlying utility

has been discovered. A variationof a naturally occurring substancemay be patentable, however, ifan inventor is able to demonstratesubstantial and non-obviousmodifications that offer advantagesof using the variant.

What is the United States Patent

and Trademark Office (USPTO)?

The USPTO is the federal agency,organized under the Department ofCommerce that administers patentson behalf of the government. TheUSPTO employs patent examinersskilled in technical fields to appraise

patent applications. The USPTOalso issues federal trademarkregistrations.

What is the definition of aninventor on a patent and whodetermines this?

Under U.S. law, an inventor isa person who takes part in theconception of the ideas set forthin the claims section of a patentapplication. Thus, inventorshipof a patent application maychange as the patent claims arechanged during prosecution of the

application. An employer or personwho only furnishes money to buildor practice an invention is not aninventor. Inventorship is a legal issueand may require an intricate legaldetermination by the patent attorneyprosecuting the application.


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Who is responsible for patenting?

UNeMed contracts with outsidepatent counsel for IP protection,thus assuring access to patentspecialists in diverse technologyareas. Inventors work with thepatent counsel in drafting the patentapplications and responses to patentoffices in the countries in whichpatents are filed.

What is the patenting process?

Patent applications are drafted bya patent attorney with an advanceddegree in your field of research.UNeMed and the patent attorney

may ask you to review a patentapplication before it is filed. Atthe time an application is filed, theinventor(s) will sign a Declarationindicating that they are an inventorand an Assignment, which formallyassigns the application to theUniversity. Two or three years later,

the USPTO will send the patentattorney written notice as to whetherthe application and its claims havebeen accepted in the form filed.Usually, the USPTO rejects theapplication because either certainformalities need to be cleared up,or the claims are not patentableover the prior art (anything thatworkers in the field have made orpublicly disclosed in the past). Thecommunication sent by the USPTOis referred to as an Office Action. Ifthe application is rejected, the patentattorney must file a written response,

usually within three to six months.Generally, the attorney may amendthe claims and/or point out why theUSPTOsposition is incorrect. This procedureis referred to as patent prosecution.Often it will take two USPTO OfficeActions and two responses by thepatent attorney -- and sometimesmore -- before the application isresolved. During this process, input

from the inventor(s) is often neededto confirm if the patent attorneyunderstands the technical aspectsof the invention and/or the prior artcited against the application. Patentprosecution ends when the USPTOsends notice that the application isallowable or when UNeMed and

the patent attorney determine that theUSPTO will not allow any subjectmatter.


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Is there such a thing as a provi-sional patent?

No. However, there is a provisionalpatent application, which isdescribed below.

What is the difference betweena provisional patent applicationand a regular (or utility) patent

application?

In certain circumstances, U.S.provisional patent applications canprovide a tool for preserving patentrights while temporarily reducingcosts and perhaps providingextra time to prepare a regular

application. This occurs becausethe provisional application doesnot need to include claims and isnot examined during the year inwhich it is pending. A regular U.S.application and related foreignapplications must be filed within oneyear of the provisional application

to receive its early filing date.However, an applicant only receivesthe benefit of the earlier filing datefor material that is adequatelydescribed and enabled in theprovisional application. As a result,the patent attorney may need yourassistance when an application isfiled as a provisional.

Whats different about foreignpatent protection?

Foreign patent protection is subjectto the laws of each individual

country, although in a general sensethe process works much the sameas it does in the United States.In foreign countries, however, aninventor will lose any patent rightsif he or she publicly discloses theinvention anywhere in the worldprior to filing a patent application. Incontrast, the United States has a oneyear grace period.

Is there such a thing as aninternational patent?

Although an international patentdoes not exist, an internationalagreement known as a PatentCooperation Treaty (PCT) providesa streamlined filing procedure for

most industrialized nations. For U.S.applicants, a PCT application isgenerally filed one year after thecorresponding U.S. application(either provisional or regular) hasbeen submitted. The PCT applicationmust be filed in the patent office ofany country in which the applicant

wishes to seek patent protectionwithin 30 months of the earliestclaimed filing date.

What is gained by filing a PCTpatent application?

A PCT patent application delaysthe need to file costly foreignapplications until the 30 monthdate, often after an applicant hasthe opportunity to further develop,evaluate and/or market theinvention for licensing.


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What is the timeline for thepatenting process and resultingprotection?

Currently, the average U.S. utilitypatent application receives its firstOffice Action two or three yearsafter filing and then undergoespatent prosecution for another twoto three years. Once a patent hasissued and all USPTO mandated

maintenance fees are paid, a patentis enforceable for 20 years from itsearliest filing date.

Why does UNeMed protect onlysome IP through patenting?

Potential commercialization partners(licensee) need patent protectionto safeguard the often sizableinvestment required to bring thetechnology to market. Due tothe expense and length of timerequired to obtain a patent, patentapplications are not possible for all

UNMC inventions.

Who decides what gets protected?

UNeMed considers manyrelevant factors when makingrecommendations about filing

patent applications. Based on arecommendation from the licensingassociate, the UNMC patentadministrator ultimately makes thefinal decision whether to file a patentapplication or seek another form ofprotection.

What does it cost to file for andobtain a patent?

Filing a regular U.S. patentapplication may cost between$8,000 and $18,000. To obtainan issued patent may require anadditional $12,000 to $20,000for patent prosecution. Filing andobtaining issued patents in othercountries will cost $25,000 ormore per country. Also, certainmaintenance fees are often requiredto keep the patent alive.


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What if I created the invention withsomeone from another institution orcompany?

Generally, the invention will bejointly owned by the University ofNebraska and the other institutionor company. Each inventor willassign his or her rights to theiremployer. If the co-owner is acompany, UNeMed may license the

Universitys IP rights to the co-owningcompany. If the co-owner is anotherresearch institution, UNeMed andthe institution will decide whichentity will manage and market theinvention.

Will the University initiate orcontinue patenting activity withoutan identified licensee?

Often UNeMed accepts the risk offiling a patent application before alicensee has been identified. Afterthe Universitys IP rights have been

licensed, the licensee usually paysthe patenting expenses. At timesUNeMed must decline further patentprosecution after a reasonableperiod (often a year or two) ofattempting to identify a licensee (orif it is determined that cannot beobtained reasonable claims from theU.S. or foreign patent office).

What is a copyright and how is ituseful?

Copyright is a form of protectionprovided by the laws of the United

States to the creators of originalworks of authorship. This includesliterary, dramatic, musical, artistic,and certain other intellectual works,as well as computer software.This protection is available to bothpublished and unpublished works.The Copyright Act generally givesthe owner of copyright the exclusiveright to conduct and authorizevarious acts, including reproduction,

public performance, and makingderivative works. Copyrightprotection is automatically securedwhen a work is fixed into a tangiblemedium such as a book, softwarecode, video, etc. In some instances,the University registers copyrights,but generally not until a commercial

product is ready for manufacture.

What is a derivative work?

A derivative work is a work basedupon one or more preexistingworks, such as a translation, musical

arrangement, dramatization,fictionalization, motion pictureversion, sound recording, artreproduction, abridgement,condensation, or any other formin which a work may be recast,transformed or adapted. A workconsisting of editorial revisions,annotations, elaborations, or othermodifications, which, as a whole,represent an original work ofauthorship, is a derivative work.The owner of a copyright generallyhas the exclusive right to createderivative work.


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How do I represent a properUniversity copyright notice?

Although copyrightable works donot require a copyright notice, werecommend that you use one. Forworks owned by UNMC, use thefollowing notice: 201X Universityof Nebraska Medical Center. Allright reserved.

What is a trademark or servicemark and how is it useful?

A trademark includes anywork, name, symbol, device,or combination, that is used in

commerce to identify and distinguishthe goods of one manufactureror seller from those manufactured orsold by others. In short, a trademarkis a brand name. A service mark isany work, name, symbol, device, orcombinationthat is used, or intended to beused, in commerce to identify anddistinguish the services of one

provider from those of others, and toindicate the source of the service.

What is a trademark registration?

Trademark registration is a procedurein which the USPTO provides adetermination of rights based uponlegitimate use of the mark. However,

it is not necessary to register atrademark or service mark to preventothers from infringing upon thetrademark. Trademarks generallybecome protected as soon as theyare adopted by an organizationand used in commerce, evenbefore registration. With a federal

trademark registration, the registrantis presumed to be entitled to usethe trademark throughout the UnitedStates for the goods or services forwhich the trademark is registered.State trademark registration is alsoavailable in Nebraska.


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MARKETINGTO FIND A LICENSEE

How does UNeMed market myinventions?

Licensing associates use manysources and strategies to identifypotential licensees and marketinventions. Sometimes existingrelationships of the inventors,UNeMed staff, and other researchersare useful in marketing an invention.Market research can assist inidentifying prospective licensees. Wealso examine other complementarytechnologies and agreements

to assist our efforts. We use ourwebsite to post inventions, leverageconferences and industry events,and make direct contacts. Facultypublications and presentations areoften excellent marketing tools aswell.

How can I assist in marketing myinvention?

First, once patent protection hasbeen sought, publish as many papersand give as many presentationsdescribing your invention as possible.Second, talk with your licensingassociate about your research andconsulting relationships.

These relationships are often helpfulin both identifying potential licenseesand technology champions within

companies. The most successfultechnology transfer results areobtained when the inventor and thelicensing professional work togetheras a team to market and sell thetechnology.


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How are most licensees found?

Studies have shown that 70% oflicensees were already known tothe inventors. Thus research andconsulting relationships are oftena valuable source for licensees.Licensees are also identified throughexisting relationships of UNeMeds

staff. Over time, our licensees oftenlicense more than one UNMCtechnology from UNeMed. Weattempt to broaden these relationshipsthrough contacts obtained fromwebsite posting inquiries, marketresearch, industry events and thecultivation of existing licensingrelationships.

How long does it take to find a

potential licensee?

It can take months and sometimesyears to locate a potentiallicensee, depending on theattractiveness of the invention, itsstage of development, competingtechnologies, and the size and

intensity of the market. Mostuniversity inventions tend to be inthe early stages of the developmentcycle and thus require substantialcommercialization investment, makingit more difficult to attract a licensee.

Can there be more than onelicensee?

Yes, an invention can be licensedto multiple licensees, either non-exclusively to several companies orexclusively to several companies,each for a unique field-of-use(application) or geography.


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CONSIDERATIONS FOR A

START-UP COMPANY

What is a start-up company and

why choose to create one?

A start-up is a new business entityformed to commercialize one or morerelated inventions. Forming a start-upcompany is an alternative to licensingthe IP to an established business.Typically, forming a company is

pursued to attract capital (e.g.Investment, Small Business InnovationResearch (SBIR) grants), aggregatehuman resources toward a commongoal, and create the opportunity ofequity return. A few key factors whenconsidering a start-up company are:

Development risk (oftencompanies in establishedindustries are unwilling to takethe risk)

Development costs versus

investment return (can theinvestors obtain their neededrates of return)

Potential for multiple productsor services from the sametechnology (few companiessurvive on one product alone)

Sufficiently large competitiveadvantage and target market

Potential revenues sufficient tosustain and grow a company

UNeMed staff has experience withstart-up companies and are happyto help you evaluate these and otherfactors.


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What role does a UNMC inventorusually play in a company?

UNMC inventors typically serve astechnology consultants, advisors or insome other technical developmentalcapacity. Rarely do faculty inventorschoose to leave the University andjoin the start-up. In many cases, theinventors role is suggested by thestart-up investors and management

team, who identify the inventorsbest role based on their expertiseand interests. As the companymatures, and additional investmentis required, the inventors role maychange. Faculty involvement of anykind in a start-up is also reviewedby a UNMC Conflict of Interest

Committee. Student inventors andpost-docs may choose to join thestart-up upon graduation but rarelyhave the experience or businessskills to serve as the companys solemanagement.

How much time, money and effort

does it take to form and operate astart-up company?

Starting a company requires aconsiderable amount of time, moneyand effort. Having a managementteam experienced in business is ofcritical importance. Until the start-upteam is identified and engaged,the faculty member will need tochampion the formation effort.After the team is in place, effort isrequired for investor discussions,formal responsibilities in or with thecompany, and University processessuch as conflict of interest reviews.

Can UNeMed accept equity in thestart-up company?

UNeMed can accept equity as partof the financial terms of the license.Equity may be substituted for othercase considerations that are oftendifficult for a start-up. It is also a wayfor UNeMed to share some of therisk associated with the start-up. A

decision to take equity must makesense for both UNeMed and thecompany.

Will the University pay forincorporating a start-up company?

No. As a separate entity, the start-up

should pay for its own legal matters,including all business incorporationmatters and licensing expenses.

What legal assistance is needed increating a start-up?

In addition to corporate counsel, the

start-up may need its own IP counselto assist with corporate patentstrategy, especially if the companywill be involved in a patent-rich area. The start-ups counselmust be separate from Universitycounsel, though it is advisable andrecommended that the corporate IPcounsel and the Universitys patentcounsel coordinate activities. Also,it is wise for investors to haveagreements regarding their roles withthe start-up reviewed by their owncounsel to ensure that all personalramifications -- including taxation andliabilities -- are clearly understood.


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LICENSEAGREEMENTS

What is a license?

A license is a permission that theowner or controller of IP grants toanother party, usually under a licenseagreement.

What is a license agreement?

License agreements describe therights and responsibilities relatedto the use and exploitation of IPdeveloped at the University. Universitylicense agreements usually stipulatethat the licensee should diligentlyseek to bring the IP into commercial

use for the public good and providea reasonable return to the University.

How is a company chosen to be alicensee?

A licensee is chosen based on

its ability to commercialize thetechnology for the benefit of thegeneral public. Sometimes anestablished company with experiencein similar technologies and marketsis the best choice. In other cases,the focus and intensity of a start-upcompany is a better option.

What can I expect to gain if my IPis licensed?

Per University policy, one third ofthe net proceeds from a licenseare provided to the inventor(s). Formore information, review the Boardof Regents policy 4.4.2 at http://nebraska.edu/board/bylaws-policies-and-rules.html or UNMCs

Policy for Royalty and EquityDistribution at http://www.unmc.edu/dept/policy.Most inventors enjoy the satisfactionof knowing their inventions are beingdeveloped for the benefit of thegeneral public. New and enhancedrelationships with businesses are

another outcome that can augmentones teaching, research andconsulting. In some cases, additionalsponsored research may result.


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What is the relationship betweenan inventor and a licensee, and

how much of my time will itrequire?

Many licensees require the activeassistance of the inventor to facilitatetheir commercialization efforts,at least at the early stages ofdevelopment. This can range from

infrequent, informal contacts to amore formal consulting relationship.Working with a new start-up canrequire substantially more time,depending on your role in or with thecompany and your continuing rolewithin UNMC. Your participationwith a start-up is governed by

University conflict of interest policiesand the approval of your supervisor.

What other types of agreementsand considerations apply totechnology?

CDAs and Non-DisclosureAgreements (NDAs) are oftenused to protect the confidentialityof an invention during evaluationby potential licensees. CDAs andNDAs also protect proprietaryinformation of third parties thatUniversity researchers need toreview to conduct research or

evaluate research opportunities.UNeMed enters into CDAs forUNMC proprietary informationshared with someone outsideof the University of Nebraskasystem.

MTAs (Material Transfer

Agreements), used for incomingand outgoing materials at theUniversity. These agreementsdescribe the terms under whichUNMC researchers and outsideresearchers may share materials,typically for research orevaluation purposes. IP rights can

be endangered if materials areused without a proper MTA.

Inter-Institutional Agreementsdescribe the terms underwhich two or more institutions(generally two universities) willcollaborate to assess, protect,

market, license, and share in therevenues received from licensingjointly owned IP.

Option Agreements, or OptionClauses within researchagreements, describe theconditions under which UNeMedpreserves the opportunity for athird party to negotiate a licensefor IP. Option clauses are oftenprovided in a SRA to corporateresearch sponsors or OptionAgreements are entered into withthird parties wishing to evaluatethe technology prior to enteringinto a full license agreement.

SRAs describe the terms underwhich sponsors provide researchsupport to the University.


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COMMERCIALIZATION

What activities occur duringcommercialization?

Most licensees continue todevelop an invention to enhancethe technology, reduce risk,prove reliability, and satisfy themarket requirements for adoptionby customers. This can involveadditional testing, prototyping or

manufacturability, durability andintegrity, and further developmentto improve performance and othercharacteristics. Documentation fortraining, installation and marketingis often created during this phase.Benchmarking tests are often requiredto demonstrate the product/service

advantages and to position theproduct in the market.

What is my role as an inventorduring commercialization?

Your role can vary depending onyour interest and involvement, theinterest of the licensee in utilizingyour services for various assignments,and any contractual obligationsrelated to the license or any personalagreements.

What revenues are generated for

the University if commercializationis successful? If unsuccessful?

Most licenses have licensing feesthat can be very modest (for start-ups or situations in which the valueof the license is deemed to warrant

a modest license fee) or can reachhundreds of thousands of dollars.

Royalties on the eventual sales ofthe licensed products can generaterevenues, although this can takeyears to occur. Equity, if included ina license, can yield returns, but onlyif a successful equity liquidation event(public equity offering or a sale ofthe company) occurs. Most licenses

do not yield substantial revenues.A recent study of licenses at U.S.universities demonstrated that only1% of all licenses yield over $1million. However, the rewards ofan invention reaching the market aremore significant than the financialconsiderations alone.

What will happen to my inventionif the start-up company or licenseeis unsuccessful in commercializingthe technology? Can the inventionbe licensed to another entity?

Licenses typically includeperformance milestones that, ifunmet, can result in termination ofthe license. This termination allowsfor subsequent licensing to anotherbusiness.


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How does the University define aconflict of interest?

A conflict of interest can occur whena University employee, througha relationship with an outsideorganization, is in a position to: 1)influence the Universitys business,

research or other areas that my leadto direct or indirect financial gain, 2)adversely impact or influence onesresearch or teaching responsibilities,or 3) provide improper advantageto others, to the disadvantage of theUniversity.

When should I seek guidance onconflict of interest?

Whenever a question of uncertaintyarises, you should seek guidancefrom your Sponsored ProgramsAdministration (SPA) representativefor research-related issues and/or

your UNeMed licensing associatefor license-related issues. Thereare two times in particular whenguidance is required: when researchproposals are submitted to externalsponsors (SPA) and when a license,option or MTA is being consideredwith a company in which the faculty

member, or any university employee,has an equity or management interest(UNeMed). UNMCs Conflict ofInterest Policy is located athttp://www.unmc.edu/dept/policy.

What kinds of issues concernconflict of interest reviewers?

Examples include the appropriateand objective use of research, thetreatment and roles of students,supervision of individuals working atboth the University and a licensee,

and conflict of commitment (i.e.,your ability to meet your Universityobligations).

What are examples of a conflict ofcommitment?

A conflict of commitment may exist ifduties, assignments or responsibilitiesassociated with a technology licenseor outside business arrangement havea negative impact on your abilityto meet commitments associatedwith your University employment orexceed the amount of time availableto you for these activities. The best

approach is to fully disclose yoursituation to your supervisor anddiscuss the implications for your jobresponsibilities.

NAVIGATING

CONFLICT OF INTEREST


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How are license revenues distrib-uted?

UNeMed is responsible formanaging the expenses andrevenues associated with technologyagreements. Per the University ofNebraska Technology Transfer Policy

(Regents 4.4.2), one third of all netproceeds are shared with inventor(s).

What are the tax implications ofany revenues I receive from theUniversity?

License revenues are typically taxedas income. You should consult a taxadvisor for specific advice.

How are inventor revenuesdistributed if there are multipleinventors and/or multiple inventionsin a license?

After a license agreement is signed,the inventors enter into a RoyaltySharing Agreement (RSA) andfile the original agreement withUNeMed. Once UNeMed receivesnet proceeds, UNeMed followsthe RSA to distribute the inventor

proceeds. If UNeMed does notreceive an RSA from the inventorsbefore net proceeds are received,then UNeMed distributes the inventorproceeds equally amongst theinventor(s).

What is a Royalty SharingAgreement?

A Royalty Sharing Agreement is aformal document signed by eachinventor of one more technologiesincluded in a license. The RSA spellsout how inventor proceeds from

the license will be distributed byUNeMed between the inventors.

REVENUE

DISTRIBUTIONS


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The laboratory notebook is a criticaldocument for both scientific and legalreasons. The proper recording ofyour ideas and accurate dating ofwhen they occurred is the first steptoward ensuring their protection.The notebook provides a permanentrecord detailing what experimentswere conducted during the studyand what inventions were madeand when. The two most importantevents that should be documented inthe notebook are conception andreduction to practice. In general,a sketch and/or a brief writtendescription are enough to establishproof of conception. Reduction to

practice is detailed during the actualexperimental process and successfultesting of a device or idea. Recordsmust be sufficiently detailed andclear to allow someone skilled inthe art to recreate the work and toconduct additional work withoutany assistance from the original

scientist. Vague entries, those entriesthat require interpretation by theoriginal scientist and entries that donot include a date do little to proveconception or reduction to practice.

The annotated notebook page thatfollows shows the main details (listed

below) that should be included in alaboratory notebook to provide thebest documentation for inventions.

Notebook number, page,date and project, signed andwitnessed (1, 14, 17, 18, 19)

Organized and legible entries (in

ink - blue preferred ) (2, 10)

Defined and referencedabbreviations and designations(3)

Detailed methods (4)

Referenced methods (5)

Identified suppliers (6)

Well known abbreviations do notneed to be defined (7, 15, 16)

Single line initialed corrections(8, 9)

Raw data identified and included(11)

Results of the experimentincluded (12)

Blocked out blank regions (13)

Abbreviations not commonshould be defined (15, 16)

LABORATORY NOTEBOOKGUIDELINES


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NOTES


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This booklet is based on the University of MichigansInventors Guide to Technology Transfer, withadaptations for the University of NebraskaMedical Center and UNeMed. We are extremelyappreciative of Ken Nisbet, Robin Rasor, Mark

Maynard, and the rest of the staff of the U-M Officeof Technology Transfer for their kind permission touse their excellent material and to the University ofMichigan for permission to use its copyright. Wewould also like to thank Madison Area TechnicalCollege, Lisa Seidman and Jeanette Mowery, foruse of their Annotated Laboratory Notebook page.


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Telephone: 402-559-2468Fax: 402-559-2182

[email protected] unemed com
http://www.unemed.com/http://www.unemed.com/

Inventor Guide 2013

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