Download - 72090 Federal Register /Vol. 64, No. 246/Thursday ... · 72090 Federal Register/Vol. 64, No. 246/Thursday, December 23, 1999/Notices ... May 25, 1999, in the Federal Register,

72090 Federal Register / Vol. 64, No. 246 / Thursday, December 23, 1999 / Notices

The meeting is closed to the public.Dated: December 16, 1999.

LaVerne Y. Stringfield,Director, Office of Federal AdvisoryCommittee Policy.[FR Doc. 99–33295 Filed 12–22–99; 8:45 am]BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

National Institutes of Health

Principles and Guidelines forRecipients of NIH Research Grants andContracts on Obtaining andDisseminating Biomedical ResearchResources: Final Notice

AGENCY: National Institutes of Health(NIH), Public Health Service, DHHS.SUMMARY: On May 25, 1999 the NationalInstitutes of Health (NIH) published forpublic comment in the Federal Registera proposed policy entitled SHARINGBIOMEDICAL RESEARCH RESOURCES:Principles and Guideline for Recipientsof NIH Research Grants and Contracts[64 FR 28205]. This policy is designedto provide recipients of NIH fundingwith guidance concerning appropriateterms for disseminating and acquiringunique research resources developedwith federal funds and is intended toassist recipients in complying with theirobligations under the Bayh-Dole Actand NIH funding policy. Comments onthe Principles and Guidelines wererequested by August 23, 1999. ThisNotice presents the final Principles andGuidelines together with NIH’s responseto the public comments received.

BackgroundThe Present policy represents part of

the overall implementation ofrecommendations made by the AdvisoryCommittee to the Director (ACD) to Dr.Harlod Varmus, Director, NIH. Dr.Varmus requested that a Working Groupof the ACD look into problemsencountered in the dissemination anduse of proprietary research tools, thecompeting interests of intellectualproperty owners and research usersunderlying these problems, and possibleNIH responses. One of therecommendations in the Report was thatNIH issue guidance to the recipients ofNIH funding.

PurposeThe present policy is a two-part

document, consisting of Principlessetting forth the fundamental conceptsand Guidelines providing specificinformation to patent and licenseprofessionals and sponsored researchadministrators for implementation. The

purpose of these Principles andGuidelines is to assist NIH fundingrecipients in determining. (1)Reasonable terms and conditions formaking NIH-funded research resourcesavailable to scientists in otherinstitutions in the public and privatesectors (disseminating research tools):and (2) restrictions to accept as acondition of receiving access to researchtools for use in NIH-funded research(acquiring research tools). The intent isto help Recipients ensure that theconditions they impose and accept onthe transfer of research tools willfacilitate further biomedical research,consistent with the requirements of theBayh-Dole Act and NIH fundingagreements. It is also hoped that thesePrinciples and Guidelines will beadopted by the wider researchcommunity so that all biomedicalresearch and development can besynergistic and accelerated.

Comments and Agency Response

The National Institutes of Health(NIH) recognizes the importance ofpublic involvement in the developmentof policy and sought widespreadcomment and participation by thevarious stakeholders in the biomedicalresearch and development communitiesregarding the proposed policy. To thisend, NIH sought comment not only fromNIH grantees, but also from academic,not-for-profit, government, and privatesector participants in biomedicalresearch and development. In order toinvolve as many stakeholders aspossible in the comment process, theproposed policy was advertised andcomments solicited in a wide variety ofvenues. In addition to its publication onMay 25, 1999, in the Federal Register,the proposed policy was made availableon several different websites includingthe Federal Register Online, numerousNIH websites (Edison, NIH Office ofTechnology Transfer, NIH Office ofExtramural Research and the NIHDirector’s Policy Forum), theAssociation of University TechnologyManagers (AUTM) website andRecombinant Capital’s SignalsMagazine. The proposed policy was alsoadvertised on a variety of e-mail lists(including Techno-L) as well as in directletters and e-mail to variousstakeholders. In addition, the proposedpolicy was profiled in articles appearingin a variety of journals and magazines,including Science, Nature and NatureBiotechnology.

In response to the May 25 proposal,NIH received 45 letters, each of whichcontained one or more comments.Comments were received from academicinstitutions, scientific foundations,

pharmaceutical companies,biotechnology companies (includingproviders of research instruments,biological reagents and genomic data),an industry trade association,professional societies, individualresearchers and other individualcommenters. Below is NIH’s response tocomments offered, organized by thesection of the proposed policy to whichthey pertain.

Introduction

Several commenters suggested thatsponsored research administrators beincluded within the target audience towhich this policy is addressed. Thissuggestion has been adopted in the finalpolicy.

Several commenters suggested thatthe policy is a de facto regulation andshould either be promulgated inaccordance with regulatory process orwithdrawn. Several other commenterssuggested that as a policy thePrinciples/Guidelines are notenforceable as law and that NIH shouldissue them as a regulation to ensurecompliance. The NIH does not believethat a regulation, enforceable as law, isrequired at this time to facilitate sharingand access to research tools for itsRecipients. Although the final policy isissued as a grants policy, to beincorporated into the NIH Grants PolicyStatement, the NIH has not precludedthe possibility of engaging in theregulatory process if widespreadproblems continue in access to NIH-funded research tools by NIHRecipients. In addition, on a case-by-case basis, the expectations set forth inthe Principles and Guidelines may beimposed as specific requirements of NIHfunding awards where the Recipient hasfailed to demonstrate sufficient progressin implementing the Principles andGuidelines.

Some commenters suggested that thepolicy should not be applicable to allprojects that include NIH grant funds,but that NIH should set a minimumlevel of NIH funding that would triggerapplication of the policy. NIH hasdetermined that the establishment ofsuch a threshold would not beconsistent with NIH’s objective ofensuring that broad availability ofresearch tools.

One commenter expressed concernthat the proposed policy, if applied torecipients of Small Business InnovationResearch (SBIR) grants, would placeSBIR recipients under conflictingdirectives. The commenter suggests thatbecause SBIR recipients are required, asa condition of their grant, to focus onthe commercialization of technology,they would be unable to disseminate

VerDate 15-DEC-99 15:24 Dec 22, 1999 Jkt 190000 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\23DEN1.XXX pfrm02 PsN: 23DEN1

72091Federal Register / Vol. 64, No. 246 / Thursday, December 23, 1999 / Notices

research tools with the minimalintellectual property encumbrancesadvocated by the proposed policy. SBIRRecipients, like other NIH grantees, aresubject to the dual obligations ofdisseminating unique research resourceswhile promoting utilization,commercialization and publicavailability of their inventions. The NIHdoes not see a conflict between theseobligations. The NIH invites its SBIRgrantees to consult with their projectofficer in the event they encounterdifficulty in the interpretation orimplementation of this policy, either ingeneral or with respect to particularunique research resources developedunder their grant.

Principles

1. Ensure Academic Freedom andPublication

Several commenters suggested thatlanguage be added to the guidelines toprohibit recipients from makingcoauthorship a condition of providingresearch tools. There appears to begeneral consensus within the researchcommunity that authorship is properlybased upon significant intellectualcontribution to the published paper. Inmost cases, simply making availableresearch materials will not, in theabsence of other contributions, justifycoauthorship. (See e.g., ResponsibleScience, Volume I: Ensuring theIntegrity of the Research Process, Panelon Scientific Responsibility and theConduct of Research, National AcademyPress, 1992, p. 52). The final policy hasbeen amended to reflect this view.

Several commenters expressedconcern that the definition of‘‘Recipient’’ in the proposed policymight not include individuals or entitiesreceiving NIH funds through‘‘cooperative agreements.’’ The policy isapplicable to cooperative agreementsand this has been clarified in thePrinciples and Guidelines.

2. Ensure Appropriate Implementationof the Bayh-Dole Act

Virtually all commenters requestedclarification on how this policy wouldpreserve incentives for the developmentand production of research tools that areultimately sold as products to theresearch community. The policy hasbeen clarified to ensure that wherepatent protection is necessary fordevelopment of a research tool as apotential product for sale anddistribution to the research community.Recipients are not discouraged fromseeking such protection, but shouldlicense the intellectual property in amanner that maximizes the potential for

broad distribution of the research tool.The policy is not intended to requireRecipient scientists to develop ofmaintain tools for widespreaddistribution, to discourage developmentof research tool products, nor to set orinfluence the price for research toolsthat are commercial products.

3. Minimize AdministrativeImpediments to Academic Research

One commenter suggested that reach-through rights should not bediscouraged because they are sometimeshelpful to Recipients by allowing themto obtain materials and equipment atreduced or nominal upfront cost. NIH isaware of this rationale for a Recipientagreeing to reach-through but finds thatsuch practices contribute not only tospecific restriction of access tosubsequent tools arising out of the NIH-funded work, but also to the generalproliferation of multiple ties andcompeting interests that is the source ofthe current access problems. NIH doesnot support the coupling ofprocurement with intellectual propertyrights and restrictions and expectsRecipients to ensure that NIH-fundedtools are not restricted as a result ofsuch agreements. Therefore, Recipientsshould engage in such interactions onan infrequent, case-by-case, and highlycontrolled and monitored basis.

4. Ensure Dissemination of ResearchResources Developed with NIH Funds

Numerous comments were receivedconcerning the conditions under whichresearch tools developed by recipientsof NIH funds are to be transferred to for-profit entities. The comments receivedreflected the wide range of opinionspresent within the life sciencescommunity on this point. On the onehand, some commenters urged thattransfer of research tools to for-profitentities be carried out under the sameterms as transfers to nonprofits/academic institutions. Thesecommenters argue that because of theincreasingly important role researchtools play in the discovery anddevelopment of new therapeuticcompounds, it is critical that these toolsbe made available to for-profit entitiesfree of onerous contractual provisions.They argue that by adopting a transferpolicy similar to that proposed fortransfers to academic laboratories, NIHwill ensure that the public will reap thebenefit of its investment in governmentresearch in the form of new andimproved pharmaceuticals. Othercommenters opposed the general ideathat the terms for transferring tools tofor-profit entities should be identical tothose for transfers of tools to academic

and non-profit organizations. Theyargue that the fundamental differencesin mission between for-profit entitiesand academic institutions justifydifferent treatment with respect to theterms under which each obtains anduses tools.

In the final policy, the NIH has leftconsiderable discretion to Recipients indetermining how to achieve theprinciple of ensuring appropriatedistribution of NIH-funded tools. Asarticulated by the policy, imposingreach-through royalty terms as acondition of use of a research tool isinconsistent with this principle. Whentransferring an NIH-funded research toolto a for-profit entity that intends to usethe tool for its own internal purposes,Recipients are entitled to capture thevalue of their invention. Arrangementssuch as execution or annual fees are anappropriate way for Recipients to do so.Royalties on the sale of a final productthat does not embody the tool, or otherreach-through rights directed to a finalproduct that does not embody the tool,discourage use of tools and are notappropriate in these circumstances.Royalties on the sale of final productsare more appropriate to situations wherea for-profit entity seeks tocommercialize the tool, e.g., bydeveloping a marketable product orservice, or incorporating the tool into amarketable product or service.

Appendix A Guidelines forImplementation

The final policy has been clarifiedwith regard to NIH intent in attachingthe more specific Guidelines to thegeneral Principles. The Principles setforth the policy that NIH is issuing to itsfunding Recipients to assist them infulfilling the dual obligations imposedby NIH grants policy with respect to thedissemination of unique researchresources, and the Bayh-Dole Act withrespect to utilization, commercializationand public availability of governmentfunded inventions. These dualobligations must be thoughtfullymanaged. The Guidelines providefurther information, model language,and suggested strategies forimplementing the principles. The modellanguage and strategies provided by theGuidelines are not intended as the solemeans by which Recipients mayimplement the articulated Principles. Itis the nature of advancing science andtechnology to present unique factualcircumstances, and NIH expects thatRecipients will determine the mostappropriate means to achieve thePrinciples for unique technologies whenthe Guidelines do not provide aworkable strategy.

VerDate 10-DEC-99 10:32 Dec 22, 1999 Jkt 190000 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\A23DE3.091 pfrm07 PsN: 23DEN1


1 The term ‘‘unique research resource’’ is used inits broadest sense to embrace the full range of toolsthat scientists use in the laboratory, including celllines, monoclonal antibodies, reagents, animalmodels, growth factors, combinatorial chemistryand DNA libraries, clones and cloning tools (suchas PCR), methods, laboratory equipment andmachines. The terms ‘‘research tools’’ and‘‘materials’’ are used throughout this documentinterchangeably with ‘‘unique research resources.’’Databases and materials subject to copyright, suchas software, are also research tools in manycontexts. Although the information provided heremay be applicable to such resources, the NIHrecognizes that databases and software presentunique questions which cannot be fully explored inthis document.

Several commenters suggested thatresearch tools be better defined and thatmore examples be used to assist indetermining whether the policy shouldbe applied and if so, what licensingstrategy is appropriate. For example,one commenter suggested that thepolicy draw a distinction between‘‘broad platform technologies’’ and‘‘product-specific technologies’’ whendetermining whether an exclusivelicense is appropriate. The final policyprovides clarification of the criteria thatRecipients might apply in determininghow to handle a particular technology.

One commenter requested that thedefinition of research tools be expandedto include diagnostic genetic testsperformed with ‘‘home-brew’’ reagents.The commenter suggested that thepatenting and exclusive licensing ofsuch tests is having a deleterious effecton clinical education, clinical research,and patient care. NIH declines toexpand the definition of research toolsto include diagnostic genetic tests.Where such tests are patented andlicensed to for-profit entities, academicmedical centers wishing to use suchlicensed tests in their clinical programsshould negotiate terms of use with thecommercial licensee.

Many commenters were of theopinion that the thirty-day time limit fordisclosure of research findings was tooshort. The final policy has beenamended to state that a delay of 30–60days is generally viewed as reasonable.This amendment is in accord withprevious NIH guidance on sponsoredresearch agreements, DevelopingSponsored Research Agreements:Considerations for Recipients of NIHResearch Grants and Contracts, 59 FR55674.

Comments were received in favor ofadopting the Simple Letter Agreementas a free-standing, one page, uniformmaterial transfer agreement. If used bythe NIH intramural program and NIHgrantees, commenters believe that themajority of transfers among and betweennot-for-profits and governmentlaboratories would be greatly simplified.In response to specific comments, theSimple Letter Agreement has beensignificantly edited and updated.Recipients are encouraged to adopt theSimple Letter Agreement as theirinstitution’s model Material TransferAgreement (MTA), and are expected touse the terms of the Simple LetterAgreement, or no more restrictive terms,for transfers of unpatented materialsdeveloped with NIH funding to otherNIH grantees.FOR FURTHER INFORMATION CONTACT: Ms.Barbara McGarey, J.D., NIH Office of

Technology Transfer, 6011 ExecutiveBoulevard, Suite 325, Rockville, MD20852–3804; Fax: (301) 402–3257; E-mail: [email protected].

Dated: December 14, 1999.Maria C. Freire,Director, Office of Technology Transfer,National Institutes of Health.

Sharing Biomedical ResearchResources: Principles and Guidelinesfor Recipients of NIH Research Grantsand Contracts

IntroductionThe National Institutes of Health is

dedicated to the advancement of healththrough science. As a public sponsor ofbiomedical research, NIH has a dualinterest in accelerating scientificdiscovery and facilitating productdevelopment. In 1997, Dr. HaroldVarmus, Director, NIH requested that aWorking Group of the AdvisoryCommittee to the Director look intoproblems encountered in thedissemination and use of uniqueresearch resources, the competinginterests of intellectual property ownersand research tool users, and possibleNIH responses.1 The Working Groupfound that intellectual propertyrestrictions can stifle the broaddissemination of new discoveries andlimit future avenues of research andproduct development. At the same time,reasonable restrictions on thedissemination of research tools aresometimes necessary to protectlegitimate proprietary interests and topreserve incentives for commercialdevelopment. One of therecommendations of the Working Groupwas that NIH issue guidance to itsfunding recipients to help them achievethe appropriate balance. That guidanceis provided in this two-part document,consisting of Principles setting forth thefundamental concepts and Guidelinesthat provide specific information topatent and license professionals andsponsored research administrators forimplementation. A copy of the fullReport of the Working Group, with more

detailed background information, isavailable at the NIH web site,www.nih.gov/welcome/forum, or fromthe NIH Office of the Director.

Principles

1. Ensure Academic Freedom andPublication

Academic research freedom basedupon collaboration, and the scrutiny ofresearch findings within the scientificcommunity, are at the heart of thescientific enterprise. Institutions thatreceive NIH research funding throughgrants, cooperative agreements orcontracts (‘‘Recipients’’) have anobligation to preserve research freedom,safeguard appropriate authorship, andensure timely disclosure of theirscientists’ research findings through, forexample, publications and presentationsat scientific meetings. Recipients areexpected to avoid signing agreementsthat unduly limit the freedom ofinvestigators to collaborate and publish,or that automatically grant co-authorship or copyright to the providerof a material.

Reasonable restrictions oncollaboration by academic researchersinvolved in sponsored researchagreements with an industrial partnerthat avoid conflicting obligations toother industrial partners, are understoodand accepted. Similarly, brief delays inpublication may be appropriate topermit the filing of patent applicationsand to ensure that confidentialinformation obtained from a sponsor orthe provider of a research tool is notinadvertently disclosed. However,excessive publication delays orrequirements for editorial control,approval of publications, or withholdingof data all undermine the credibility ofresearch results and are unacceptable.

2. Ensure Appropriate Implementationof the Bayh-Dole Act

When a Recipient’s research work isfunded by NIH, the activity is subject tovarious laws and regulations, includingthe Bayh-Dole Act (35 U.S.C. 200 etseq.). Generally, Recipients are expectedto maximize the use of their researchfindings by making them available tothe research community and the public,and through their timely transfer toindustry for commercialization.

The right of Recipients to retain titleto inventions made with NIH fundscomes with the correspondingobligations to promote utilization,commercialization, and publicavailability of these inventions. TheBayh-Dole Act encourages Recipients topatent and license subject inventions asone means of fulfilling these obligations.



2 Research tools obtained or derived from humantissues constitute a special case. Certain restrictionson the use and further dissemination of such toolsmay be appropriate to ensure consistency withdonor consent and human subjects protection. See45 CFR Part 46.

However, the use of patents andexclusive licenses is not the only, nor insome cases the most appropriate, meansof implementing the Act. Where thesubject invention is useful primarily asa research tool, inappropriate licensingpractices are likely to thwart rather thanpromote utilization, commercializationand public availability of the invention.

In determining an intellectualproperty strategy for an NIH-fundedinvention useful primarily as a researchtool, Recipients should analyze whetherfurther research, development andprivate investment are needed to realizethis primary usefulness. If it is not, thegoals of the Act can be met throughpublication, deposit in an appropriatedatabank or repository, widespread non-exclusive licensing or any other numberof dissemination techniques. Restrictivelicensing of such an invention, such asto a for-profit sponsor for exclusiveinternal use, is antithetical to the goalsof the Bayh-Dole Act.

Where private sector involvement isdesirable to assist with maintenance,reproduction, and/or distribution of thetool, or because further research anddevelopment are needed to realize theinvention’s usefulness as a researchtool, licenses should be crafted to fit thecircumstances, with the goal of ensuringwidespread and appropriate distributionof the final tool product. Exclusivelicensing of such an invention, such asto a distributor that will sell the tool orto a company that will invest in thedevelopment of a tool from the nascentinvention, can be consistent with thegoals of the Bayh-Dole Act.

3. Minimize AdministrativeImpediments to Academic Research

Each iteration in a negotiation overthe terms of a license agreement ormaterials transfer agreement delays themoment when a research tool may beput to use in the laboratory. Recipientsshould take every reasonable step tostreamline the process of transferringtheir own research tools freely to otheracademic research institutions usingeither no formal agreement, a coverletter, the Simple Letter Agreement ofthe Uniform Biological MaterialsTransfer Agreement (UBMTA), or theUBMTA itself. The Appendix containsan updated free-standing version of theSimple Letter Agreement that is stronglyencouraged for transfers of unpatentedresearch materials among Recipients.

Where they have not already done so,Recipients should develop andimplement clear policies whicharticulate acceptable conditions foracquiring resources, and refuse to yieldon unacceptable conditions. NIHacknowledges the concern of some for-

profit organizations that the concept ofpurely academic research may bediluted by the close ties of some not-for-profit organizations with for-profitentities, such as research sponsors andspin-off companies in which suchorganizations take equity. Of concern towould-be providers is the loss of controlover a proprietary research tool that,once shared with a not-for-profitRecipient for academic research, resultsin commercialization gains to theproviders’ for-profit competitors.Recipients must be sensitive to thislegitimate concern if for-profitorganizations are expected to share toolsfreely.

For-profit organizations, in turn, mustminimize the encumbrances they seekto impose upon not-for-profitorganizations for the academic use oftheir tools. Reach-through royalty orproduct rights, unreasonable restraintson publication and academic freedom,and improper valuation of tools impedethe scientific process whether imposedby a not-for-profit or for-profit providerof research tools. While these Principlesare directly applicable only to recipientsof NIH funding, it is hoped that othernot-for-profit and for-profitorganizations will adopt similar policiesand refrain from seeking unreasonablerestrictions or conditions when sharingmaterials.

4. Ensure Dissemination of ResearchResources Developed With NIH Funds

Progress in science depends uponprompt access to the unique researchresources that arise from biomedicalresearch laboratories throughoutgovernment, academia, and industry.Ideally, these new resources flow toothers who advance science byconducting further research. Promptaccess can be accomplished in a numberof ways, depending on the type ofresource that has been developed,whether it has broad or specific uses,and whether it is immediately useful orprivate sector investment is needed torealize its usefulness. The goal iswidespread, timely distribution of toolsfor further discovery. When researchtools are used only within one or asmall number of institutions, there is agreat risk that fruitful avenues ofresearch will be neglected.

Unique research resources arisingfrom NIH-funded research are to bemade available to the scientific researchcommunity. Recipients are expected tomanage interactions with third partiesthat have the potential to restrictRecipients’ ability to disseminateresearch tools developed with NIH

funds.2 For example, a Recipient mightuse NIH funds with funds from one ormore third party sponsors, or acquire aresearch tool from a third party providerfor use in an NIH-funded researchproject. Either situation may result in aRecipient incurring obligations to athird party that conflict with Recipient’sobligations to the NIH. To avoidinconsistent obligations, Recipients areencouraged to share these Principleswith potential co-sponsors of researchprojects and third party providers ofmaterials.

Recipients should also examine and,where appropriate, simplify the transferof materials developed with NIH fundsto for-profit institutions for internal useby those institutions. NIH endorsesdistinguishing internal use by for-profitinstitutions from the right tocommercial development and sale orprovision of services. In instances wherethe for-profit institution is seekingaccess for internal use purposes,Recipients are encouraged to transferresearch tools developed with NIHfunding to such institutions withoutseeking option rights or royalties on thefinal product.

Summary

Access to research tools is aprerequisite to continuing scientificadvancement. Ensuring broad accesswhile preserving opportunities forproduct development requiresthoughtful, strategic implementation ofthe Bayh-Dole act. The NIH urgesRecipients to develop patent, license,and material sharing policies with thisgoal in mind, realizing both productdevelopment as well as the continuingavailability of new research tools to thescientific community.

Appendix—Guidelines forImplementation

The following Guidelines providespecific information, strategies, andmodel language for patent and licenseprofessionals and sponsored researchadministrators at Recipient institutionsto assist in implementing the Principleson Obtaining and DisseminatingBiomedical Resources. Recipients areencouraged to use the strategies below,other strategies developed at their owninstitutions, or any other appropriatemeans of achieving the Principles.



Guidelines for Disseminating ResearchResources Arising Out of NIH-FundedResearch

Definition of Research ToolsThe definition of research tools is

necessarily broad, and it isacknowledged that the same materialcan have different uses, being a researchtool in some contexts and a product inothers. In determining how an NIH-funded resource that falls within thedefinition should be handled,Recipients should determine whether:(1) The Primary usefulness of theresource is as a tool for discovery ratherthan an FDA-approved product orintegral component of such a product;(2) the resource is a broad, enablinginvention that will be useful to manyscientists (or multiple companies indeveloping multiple products), ratherthan a project or product-specificresource; and (3) the resource is readilyuseable or distributable as a tool ratherthan the situation where private sectorinvolvement is necessary or the mostexpedient means for developing ordistributing the resource. Recipientsshould ensure that their intellectualproperty strategy for resources fittingone or more of the above criteriaenhances rather than restricts theultimate availability of the resource. IfRecipient believes private sectorinvolvement is desirable to achieve thisgoal, Recipient should strategicallylicense the invention under termscommensurate with the goal.

Use of Simple Letter AgreementRecipients are expected to ensure that

unique research resources arising fromNIH-funded research are made availableto the scientific research community.The majority of transfers to not-for-profit entities should be implementedunder terms no more restrictive than theUBMTA. In particular, Recipients areexpected to use the Simple LetterAgreement provided below, or anotherdocument with no more restrictiveterms, to readily transfer unpatentedtools developed with NIH funds to otherRecipients for use in NIH-fundedprojects. If the materials are patented orlicensed to an exclusive provider, otherarrangements may be used, butcommercialization option rights, royaltyreach-through, or product reach-throughrights back to the provider areinappropriate.

Similarly, when for-profit entities areseeking access to NIH-funded tools forinternal use purposes, Recipientsshould ensure that the tools aretransferred with the fewestencumbrances possible. The SimpleLetter Agreement may be expanded for

use in transferring tools to for-profitentities, or simple internal use licenseagreements with execution or annualuse fees may be appropriate.

Simple Letter Agreement for theTransfer of Materials

In response to RECIPIENT’s requestfor the MATERIAL [insert description]lllll the PROVIDER asks that theRECIPIENT and the RECIPIENTSCIENTIST agree to the following beforethe RECIPIENT receives the MATERIAL:

1. The above MATERIAL is theproperty of the PROVIDER and is madeavailable as a service to the researchcommunity.

2. THIS MATERIAL IS NOT FOR USEIN HUMAN SUBJECTS.

3. The MATERIAL will be used forteaching or not-for-profit researchpurposes only.

4. The MATERIAL will not be furtherdistributed to others without thePROVIDER’s written consent. TheRECIPIENT shall refer any request forthe MATERIAL to the PROVIDER. Tothe extent supplies are available, thePROVIDER or the PROVIDERSCIENTIST agree to make theMATERIAL available, under a separateSimple Letter Agreement to otherscientists for teaching or not-for-profitresearch purposes only.

5. The RECIPIENT agrees toacknowledge the source of theMATERIAL in any publicationsreporting use of it.

6. Any MATERIAL deliveredpursuant to this Agreement isunderstood to be experimental in natureand may have hazardous properties.THE PROVIDER MAKES NOREPRESENTATIONS AND EXTENDSNO WARRANTIES OF ANY KIND,EITHER EXPRESSED OR IMPLIED.THERE ARE NO EXPRESS OR IMPLIEDWARRANTIES OFMERCHANTABILITY OR FITNESS FORA PARTICULAR PURPOSE, OR THATTHE USE OF THE MATERIAL WILLNOT INFRINGE ANY PATENT,COPYRIGHT, TRADEMARK, OROTHER PROPRIETARY RIGHTS. Unlessprohibited by law, Recipient assumes allliability for claims for damages againstit by third parties which may arise fromthe use, storage or disposal of theMaterial except that, to the extentpermitted by law, the Provider shall beliable to the Recipient when the damageis caused by the gross negligence orwillful misconduct of the Provider.

7. The RECIPIENT agrees to use theMATERIAL in compliance with allapplicable statutes and regulations.

8. The MATERIAL is provided at nocost, or with an optional transmittal feesolely to reimburse the PROVIDER for

its preparation and distribution costs. Ifa fee is requested, the amount will beindicated here: lllll

The PROVIDER, RECIPIENT andRECIPIENT SCIENTIST must sign bothcopies of this letter and return onesigned copy to the PROVIDER. ThePROVIDER will then send theMATERIAL.

Provider Information and AuthorizedSignature

Provider Scientist: llllllllllllProvider Organization: llllllllllAddress: llllllllllllllllName of Authorized Official: lllllllTitle of Authorized Official: lllllllCertification of Authorized Official: ThisSimple Letter Agreement ll has ll hasnot [check one] been modified. If modified,the modification are attached.lllllllllllllllllllll(Signature of Authorized Official) (Date)

Recipient Information and AuthorizedSignature

Recipient Scientist: lllllllllllRecipient Organization: lllllllllAddress: llllllllllllllllName of Authorized Official: llllllTitle of Authorized Official: lllllllSignature of Authorized Official: lllllDate: llllllllllllllllllCertification of Recipient Scientist: I haveread and understood the conditions outlinedin this Agreement and I agree to abide bythem in the receipt and use of theMATERIAL.lllllllllllllllllllll(Recipient Scientist) (Date)

Ensuring Consistent Obligations

Recipients must ensure thatobligations to other sources of fundingof projects in which NIH funds are usedare consistent with the Bayh-Dole Actand NIH funding requirements. Uniqueresearch resources generated under suchprojects are expected to be madeavailable to the research community.Recipients are encouraged to share theseGuidelines with potential co-sponsors.Any agreements covering projects inwhich NIH funds will be used alongwith other funds are expected to containlanguage to address the issue ofdissemination of unique researchresources. Examples of possiblelanguage follow. The paragraphs arepresented in a ‘‘mix and match’’ format:

‘‘The project covered by this agreement issupported with funding from the NationalInstitutes of Health. Provider agrees thatupon publication, unpatented uniqueresearch resources arising out of this projectmay be freely distributed.’’

‘‘In the event an invention is primarilyuseful as a research tool, any option grantedshall either be limited to a non-exclusivelicense or the terms of any resultingexclusive license shall include provisionsthat ensure that the research tool will be



available to the academic researchcommunity on reasonable terms.’’

‘‘Provider agrees that Recipient shall havethe right to make any materials andinventions developed by Recipient in thecourse of the collaboration (includingmaterials and inventions developed jointlywith Provider, but not including anyProvider materials (or parts thereof) orProvider sole inventions available to otherscientists at not-for-profit organizations foruse in research, subject to Provider’sindependent intellectual property rights.’’

‘‘Subject to Recipient’s obligations to theU.S. government, including 37 CFR Part 401,the NIH Grants Policy Statement, and theNIH Guidelines for Obtaining andDisseminating Biomedical ResearchResources, Recipient grants to Sponsor thefollowing rights: * * *’’

Limiting Exclusive Licenses toAppropriate Field of Use

Exclusive licenses for research tools(where no further research anddevelopment is needed to realize theinvention’s usefulness as a tool) shouldgenerally be avoided except in caseswhere the licensee undertakes to makethe research tool widely available toresearchers through unrestricted sale, orthe licensor retains rights to make theresearch tool widely available. When anexclusive license is necessary topromote investment in commercialapplications of a subject invention thatis also a research tool, the Recipientshould ordinarily limit the exclusivelicense to the commercial field of use,retaining rights regarding use anddistribution as a research tool. Examplesof possible language include:

‘‘Research License’’ means anontransferable, nonexclusive license tomake and to use the Licensed Products orLicensed Processes as defined by theLicensed Patent Rights for purposes ofresearch and not for purposes of commercialmanufacture, distribution, or provision ofservices, or in lieu of purchase, or fordeveloping a directly related secondaryproduct that can be sold. Licensor reservesthe right to grant such nonexclusive ResearchLicenses directly or to require Licenses onreasonable terms. The purpose of thisResearch License is to encourage basicresearch, whether conducted at an academicor corporate facility. In order to safeguard theLicensed Patent Rights, however, Licensorshall consult with Licensee before granting tocommercial entities a Research License orproviding to them research samples of thematerials.’’

‘‘Licensor reserves the right to provide theBiological Materials and to grant licensesunder Patent Rights to not-for-profit andgovernmental institutions for their internalresearch and scholarly use.’’

‘‘Notwithstanding anything to the contraryin this agreement, Licensor shall retain apaid-up, nonexclusive, irrevocable license topractice, and to sublicense other not-for-profit research organizations to practice, thePatent Rights for internal research use.’’

‘‘The grant of rights provided herein issubject to the rights of the United Statesgovernment pursuant to the Bayh-Dole Actand is limited by the right of the Licensor touse Patent Rights for its own research andeducational purposes and to freely distributeMaterials to not-for-profit entities for internalresearch purposes.’’

‘‘Licensor reserves the right to supply anyor all of the Biological materials to academicresearch scientists, subject to limitation ofuse by such scientists for research purposesand restriction from further distribution.’’

‘‘Licensor reserves the right to practiceunder the Patent Rights and to use anddistribute to third parties the TangibleProperty for Licensor’s own internal researchpurposes.’’

Guidelines for Acquiring ResearchResources for Use in NIH-FundedResearch

Prompt PublicationAgreements to acquire materials for

use in NIH-funded research areexpected to address the timelydissemination of research results.Recipients should not agree tosignificant publication delays, anyinterference with the full disclosure ofresearch findings, or any undueinfluence on the objective reporting ofresearch results. A delay of 30–60 daysto allow for patent filing or review forconfidential proprietary information isgenerally viewed as reasonable.

Definition of MaterialsUnder the Bayh-Dole Act and its

implementing regulations, agreementsto acquire materials for use in NIH-funded projects cannot require that titleto resulting inventions be assigned tothe provider. For this reason, definitionsof ‘‘materials’’ that include allderivatives or modifications areunacceptable. Other unacceptablevariations include definitions of‘‘materials’’ that include anyimprovements, or any other materialsthat could not have been made withoutthe provided material. Conversely, it isimportant for providers of materials tobe aware that a Recipient does not gainany ownership or interest in aprovider’s material by virtue of theRecipient using the material in an NIH-funded activity. Examples of acceptabledefinitions for ‘‘materials’’ include:

‘‘ ‘Materials’ means the materials providedas specified in this document.’’

‘‘ ‘Materials’ means the materials providedas specified in this document. Materials mayalso include Unmodified Derivatives of thematerials provided, defined as substancescreated by the Recipient which constitute anunmodified functional subunit or productexpressed by the original material, such assubclones of unmodified cell lines, purifiedor fractionated subsets of the originalmaterials, proteins expressed by DNA/RNA

supplied by the Provider, or monoclonalantibodies secreted by a hybridoma cellline.’’

‘‘ ‘Materials’ means the materials providedas specified in this document. Materials mayalso include Progeny and UnmodifiedDerivatives of the materials provided.Progeny is an unmodified descendant fromthe original material, such as virus fromvirus, cell from cell, or organism fromorganism. Unmodified Derivatives aresubstances created by the Recipient whichconstitute an unmodified functional subunitor product expressed by the original material,such as subclones of unmodified cell lines,purified or fractionated subsets of theoriginal material, proteins expressed byDNA/RNA supplied by the Provider, ormonoclonal antibodies secreted by ahybridoma cell line.’’

‘‘ ‘Materials’ means the materials beingtransferred as specified in this document.Materials shall not include: (a) Modifications,or (b) other substances created by therecipient through the use of the Materialwhich are not Modifications, Progeny, orUnmodified Derivatives. Progeny is anunmodified descendant from the Material,such as virus from virus, cell from cell, ororganism from organism. UnmodifiedDerivatives are substances created by theRecipient which constitute an unmodifiedfunctional subunit or product expressed bythe original Material, such as subclones ofunmodified cell lines, purified orfractionated subsets of the original Material,proteins expressed by DNA/RNA supplied bythe Provider, or monoclonal antibodiessecreted by a hybridoma cell line.’’ [Source:Uniform Biological Materials TransferAgreement; terms defined therein]

Ensuring Consistent Obligations

Recipients are expected to avoidsigning agreements to acquire researchtools that are likely to restrictRecipients’ ability to promote broaddissemination of additional tools thatmay arise from the research. This mightoccur when an agreement gives aprovider an exclusive license option toany new intellectual property arisingout of the project. A new transgenicmouse developed during the projectcould fall under this license option andbecome unavailable to third partyscientists as a result. Examples ofagreements to examine include materialtransfer agreements (MTAs),memoranda of understanding (MOU),research or collaboration agreements,and sponsored research agreements.Recipients should consider adoptingstandard language to place in suchagreements to address this issue. Thefollowing are examples of possiblelanguage to include in MTAs, sponsoredresearch agreements, and otheragreements that either acquire materialsfrom or co-mingle funds with non-government sources. The paragraphs arepresented in a ‘‘mix and match’’ format:



‘‘The project covered by this agreement issupported with funding from the NationalInstitutes of Health. Provider agrees that afterpublication, unpatented unique researchresources arising out of this project may befreely distributed.’’

‘‘In the event an invention is primarilyuseful as a research tool, any option grantedshall either be limited to a non-exclusivelicense or the terms of any resultingexclusive license shall include provisionswhich insure that the research tool will beavailable to the academic researchcommunity on reasonable terms.’’

‘‘Provider agrees that Recipient shall havethe right to make any materials andinventions developed by Recipient in thecourse of the collaboration (includingmaterials and inventions developed jointlywith Provider, but not including anyProvider materials (or parts thereof) orProvider sole inventions available to otherscientists at not-for-profit organizations foruse in research, subject to Provider’sindependent intellectual property rights.’’

‘‘Subject to Recipient’s obligations to theU.S. government, including 37 CFR Part 401,the NIH Grants Policy Statement, and theNIH Guidelines for Obtaining andDisseminating Biomedical ResearchResources, Recipient grants to Sponsor thefollowing rights: * * *’’

Grantbacks and Option Rights• Agreements to acquire materials

from for-profit entities for use in NIH-funded research may provide a grantback of non-exclusive, royalty-freerights to the provider to useimprovements and new uses of thematerial that, if patented, wouldinfringe any patent claims held by theprovider. They may also provide anoption for an exclusive or non-exclusivecommercialization license to newinventions arising directly from use ofthe material. These should be limited tocircumstances where the materialsought to be acquired is unique, such asa patented proprietary material, and notreasonably available from any othersource. A non-exclusive ‘‘grant-back’’might be used, for example, to protecta for-profit entity that provides aproprietary compound from beingblocked from using new uses orimprovements of that compounddiscovered during the NIH-fundedproject. In providing license options,Recipients must ensure that licensesgranted to providers under such optionsare consistent with Bayh-Dolerequirements, including the preferencefor U.S. industry requirements andreservation of government rights under47 CFR part 401.

• In determining the scope of licenseor option rights that are granted inadvance to a provider of materials,Recipient should balance the relativevalue of the provider’s contributionsagainst the value of the rights granted,

cost of the research, and importance ofthe research results. The rights grantedto providers should be limited toinventions that have been made directlythrough the use of the materialsprovided. In addition, Recipients shouldreserve the right to negotiate licenseterms that will ensure: (1) continuingavailability to the research community ifthe new invention is a unique researchresource; (2) that the provider has thetechnical and financial capability andcommitment to bring all potentialapplications to the marketplace in atimely manner; and (3) that if anexclusive license is granted, theprovider will provide a commercialdevelopment plan and agree tobenchmarks and milestones for anyfields of use granted.

• It is expected that agreements toacquire NIH-funded materials from not-for-profit entities for use in NIH-fundedresearch will not includecommercialization option rights, royaltyreach-through, or product reach-throughrights back to the provider. Suchmaterials should be acquired under theSimple Letter Agreement or UBMTA, or,if the materials are patented,a simplelicense agreement that does not requestreach-through to either future productsor royalties. If the providing not-for-profit organization is constrained insharing the material due to a pre-existing sponsored research agreementor license, NIH expects that not-for-profit provider to negotiate a suitableresolution with the private researchsponsor or licensee. The co-mingling ofNIH and sponsored research funds isallowed, however, Recipient isresponsible for ensuring that conditionson the use of the sponsored funds donot interfere with the opendissemination of research tools.[FR Doc. 99–33292 Filed12–22–99; 8:45 am]BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Substance Abuse and Mental HealthServices Administration

Center for Substance AbusePrevention; Notice of Meeting

Pursuant to Public Law 92–463,notice is hereby given of the meeting ofthe Center for Substance AbusePrevention (CSAP) National AdvisoryCouncil in January 2000.

The meeting will be open. The agendawill include presentations and updateson CSAP’s programs, the SAMHSAAdministrator’s Report, a CSAP budgetupdate, and discussions of

administrative matters andannouncements. If anyone needs specialaccommodations for persons withdisabilities, please notify the contactlisted below.

A summary of this meeting, a rosterof committee members, and substantiveprogram information may be obtainedfrom the contact listed below.

Committee Name: Center for SubstanceAbuse Prevention National Advisory Council

Meeting Dates: January 10, 2000, 9 a.m.–5p.m. (Open)

Place: Bethesda Marriott Hotel, 5151 PooksHill Road, Bethesda, Maryland 20841.

Contact: Yuth Nimit, Ph.D., 5600 FishersLane, Rockwall II Building, Suite 901,Rockville, Maryland 20857, Telephone: (301)443–8455.

Dated: December 17, 1999.Sandra Stephens,Acting Committee Management Officer,Substance Abuse and Mental Health ServicesAdministration.[FR Doc. 99–33306 Filed 12–22–99; 8:45 am]BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING ANDURBAN DEVELOPMENT

[Docket No. FR–4432–N–51]

Federal Property Suitable as Facilitiesto Assist the Homeless

AGENCY: Office of the AssistantSecretary for Community Planning andDevelopment, HUD.ACTION: Notice.

SUMMARY: This Notice identifiesunutilized, underutilized, excess, andsurplus Federal property reviewed byHUD for suitability for possible use toassist the homeless.FOR FURTHER INFORMATION CONTACT:Clifford Taffet, room 7266, Departmentof Housing and Urban Development,451 Seventh Street SW, Washington, DC20410; telephone (202) 708–1234; TTYnumber for the hearing- and speech-impaired (202) 708–2565 (thesetelephone numbers are not toll-free), orcall the toll-free Title V information lineat 1–800–927–7588.SUPPLEMENTARY INFORMATION: Inaccordance with 24 CFR Part 581 andsection 501 of the Stewart B. McKinneyHomeless Assistance Act (42 U.S.C.11411), as amended, HUD is publishingthis Notice to identify Federal buildingsand other real property that HUD hasreviewed for suitability for use to assistthe homeless. The properties werereviewed using information provided toHUD by Federal landholding agenciesregarding unutilized and underutilizedbuildings and real property controlled


Download - 72090 Federal Register /Vol. 64, No. 246/Thursday ... · 72090 Federal Register/Vol. 64, No. 246/Thursday, December 23, 1999/Notices ... May 25, 1999, in the Federal Register,

Top Related