1 technology transfer transactions: implications to supporting policy, statutes, and enhanced...

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Technology Transfer Transactions: Technology Transfer Transactions: Implications to supporting policy, Implications to supporting policy,

statutes, and enhanced statutes, and enhanced partnership opportunitiespartnership opportunities

Richard J. Brenner, Ph.D.Richard J. Brenner, Ph.D.Assistant Administrator of ARSAssistant Administrator of ARSOffice of Technology TransferOffice of Technology Transfer

Panelists: June Blalock, Gail Poulos, Panelists: June Blalock, Gail Poulos, Rob Griesbach, Tom MorelandRob Griesbach, Tom Moreland

Enhancing & Documenting the Impact of Research OutcomesEnhancing & Documenting the Impact of Research Outcomes

APHIS Annual Agreements ConferenceApril 7, 2009

Riverdale, MD

Why Do We Do Technology Why Do We Do Technology Transfer at ARS?Transfer at ARS?

Required by law (15 USC 3710a)

Helps fulfill our mission to serve the public good

Documents impact of scientists’ research outcomes

Enhances the public’s perception of ARS

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Goals of Technology Goals of Technology TransferTransfer Transfer of technology is primary

objective, not income.

Facilitate research partnerships & adoption of federal research outcomes for broad U.S. public benefit.

Protect intellectual property primarily if it enhances technology transfer, using the patent system that provides incentives for scientists and protection for U.S. industry.

Enhance U.S. economic development, global competition, and sustainable economic security.

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IntramuralIntramural research by federal employees, federally research by federal employees, federally funded funded Special Cooperative Research And Development Special Cooperative Research And Development

Agreement (CRADA) authority with private sector Agreement (CRADA) authority with private sector companiescompaniesright to negotiate exclusive license without Federal Register right to negotiate exclusive license without Federal Register

notice; confidentiality of data up to 5 yearsnotice; confidentiality of data up to 5 years Technology transfer becomes an obligation “…of Technology transfer becomes an obligation “…of

each laboratory science & engineering professional;” each laboratory science & engineering professional;” royalties capped at $150K / inventor / year royalties capped at $150K / inventor / year

Extends licensing to “protectable” inventionExtends licensing to “protectable” invention

Stevenson-Wydler Act, 1980Stevenson-Wydler Act, 1980Federal Technology Transfer Act, 1986 (FTTA)Federal Technology Transfer Act, 1986 (FTTA)National Technology Transfer and National Technology Transfer and

Advancement Act, 1995Advancement Act, 1995Technology Transfer Commercialization Act, Technology Transfer Commercialization Act,

20002000

U.S. Technology Transfer U.S. Technology Transfer LegislationLegislation

-- public sector, -- public sector, federalfederal researchers researchers ----

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“Technology transfer, consistent with mission responsibilities, is a responsibility of each laboratory science and engineering professional.”

15USC§3710(a)(2)

Federal LawFederal Law

“Each laboratory director shall ensure that efforts to transfer technology are considered positively in laboratory job descriptions, employee promotion policies, and evaluation of the job performance of scientists and engineers in the laboratory.”

15USC§3710(a)(3)

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-- public sector, -- public sector, non-federalnon-federal researchers --researchers --

Bayh-Dole Act, Bayh-Dole Act, 19801980

ExtramuralExtramural research with federal funds research with federal funds (university, private research firms, etc.) (university, private research firms, etc.)

Right to take title to invention and Right to take title to invention and license according to license according to institution policies & institution policies & practices practices

Rights “flow with the funds”Rights “flow with the funds” If elect If elect notnot to take title, or if patent to take title, or if patent

prosecution / patent maintenance is prosecution / patent maintenance is abandoned, abandoned, rights must be returned to rights must be returned to federal governmentfederal government

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Why has Congress spent so much time Why has Congress spent so much time on this issue over the past 25 years?on this issue over the past 25 years?

To help translate research results To help translate research results into practical productsinto practical products

To give taxpayers a return on their To give taxpayers a return on their investment in researchinvestment in research

To promote economic To promote economic competitiveness and job creationcompetitiveness and job creation

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Our Current Our Current Environment…Environment…

Economic crisis ( National, Economic crisis ( National, states, local), energy crisis, states, local), energy crisis, global warming, food shortages, global warming, food shortages, water issues, land management, water issues, land management, unemployment rising, global unemployment rising, global competition, emerging plant, competition, emerging plant, animal and human diseases, animal and human diseases, natural disasters …natural disasters …

There is an urgent need for innovation and There is an urgent need for innovation and creative partnering to develop creative partnering to develop technology to meet these multiple technology to meet these multiple challengeschallenges

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Technology Transfer: Technology Transfer: the adoption the adoption of research outcomes for public of research outcomes for public

benefitbenefit

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and Technology Transferand Technology TransferThe Changing Landscape of The Changing Landscape of Technology …Technology …

Office of Technology Office of Technology TransferTransfer

Coordinates Tech Transfer activities in ARSCoordinates Tech Transfer activities in ARS Has authority to develop and sign Has authority to develop and sign

Cooperative Research And Development Cooperative Research And Development Agreements (CRADAs) for ARS and to Agreements (CRADAs) for ARS and to review those of other USDA agenciesreview those of other USDA agencies

Has sole authority, delegated by the Has sole authority, delegated by the Secretary of Agriculture for licensing any Secretary of Agriculture for licensing any inventions developed from intramural inventions developed from intramural research within any of the USDA agencies research within any of the USDA agencies (including Forest Service (FS), Food (including Forest Service (FS), Food Safety Inspection Service (FSIS), Animal & Safety Inspection Service (FSIS), Animal & Plant Health Inspection Service (APHIS))Plant Health Inspection Service (APHIS))Facilitating partnerships to adopt

research outcomes for broad public availability

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Office of Technology Transfer

Office of Technology Transfer

Patenting

• 8 registered patent agents (1 Ph.D, 4 w/ law degrees; 1 MBA)

• Located in Beltsville, MD; Peoria, IL; Albany, CA

Licensing

• 4 senior licensing specialists (2 w / law degrees; 2 MBA)

• HQ based

Tech Transfer Coordinators

• 8 specialists with life science / ag background (4 Ph.D, 1 law degree)

• Distributed across geographic Areas of ARS

Marketing

• Targeted marketing (staff of 3)

• Web subscribe Tech Alerts

• Partnering opportunities

Centralized in policy and approvals, licensing, marketing; decentralized in negotiation and implementation of CRADAs

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David Nicholson – [email protected]

Rob Griesbach [email protected]

Don Nordlund – SAA/ [email protected]

Renee Wagner – [email protected]

Thomas ValcoCotton Tech Tran & Education [email protected]

Bryan Kaphammer – NPA / [email protected]

Vic [email protected]

Joe Lipovsky – SRRC Assoc. [email protected]

Technology Transfer Coordinators

Office of Technology TransferOffice of Technology TransferOffice of Technology TransferOffice of Technology Transfer

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Office of Technology TransferOffice of Technology TransferOffice of Technology TransferOffice of Technology TransferPatent Advisors

Beth Sampson / Howard Owens – PWA510-559-6067 / [email protected]@ars.usda.gov

Byron Stover - [email protected]

Gail Poulos – SAA Robert [email protected]

Albert Tsui – MWA & [email protected]

Evelyn Rabin - MSA301 [email protected]

Albert Tsui – NPA309-681-6512 [email protected]

Byron Stover –[email protected] Rabin -- NAA301 [email protected]

Randy Deck – MWA & [email protected]

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Richard BrennerAssistant Administrator (AA)

Martha SteinbockDeputy Assistant Administrator (DAA)

June Blalock June Blalock AAAA

Tech Licensing CoordinatorTech Licensing CoordinatorJune Blalock June Blalock AAAA

Tech Licensing CoordinatorTech Licensing Coordinator

Licensing StaffLicensing StaffLicensing StaffLicensing Staff

Brian NakanishiBrian NakanishiLicensing Specialist Licensing Specialist Brian NakanishiBrian NakanishiLicensing Specialist Licensing Specialist

Diana TuckerDiana TuckerLicensing Specialist Licensing Specialist Diana TuckerDiana TuckerLicensing Specialist Licensing Specialist

Kalpana ReddyKalpana ReddyLicensing Specialist Licensing Specialist Kalpana ReddyKalpana ReddyLicensing Specialist Licensing Specialist

Carla Boettinger Carla Boettinger Program AnalystProgram AnalystCarla Boettinger Carla Boettinger Program AnalystProgram Analyst

Deborah Penot Deborah Penot Foreign Patent SpecialistForeign Patent SpecialistDeborah Penot Deborah Penot Foreign Patent SpecialistForeign Patent Specialist

Dianne HoffmannDianne HoffmannLegal Instruments Legal Instruments ExaminerExaminer

Dianne HoffmannDianne HoffmannLegal Instruments Legal Instruments ExaminerExaminer

Kim MeltonKim MeltonLicensing AssistantLicensing AssistantKim MeltonKim MeltonLicensing AssistantLicensing Assistant

Beltsville, MDBeltsville, MDBeltsville, MDBeltsville, MD

Byron StoverByron StoverPatent Advisor Patent Advisor (BA, ERRC & Chemical)(BA, ERRC & Chemical)

Byron StoverByron StoverPatent Advisor Patent Advisor (BA, ERRC & Chemical)(BA, ERRC & Chemical)

VacantVacant AAAA

Marketing Specialist Marketing Specialist VacantVacant AAAA

Marketing Specialist Marketing Specialist

Natasha SnuggsNatasha SnuggsMarketing AssistantMarketing AssistantNatasha SnuggsNatasha SnuggsMarketing AssistantMarketing Assistant

Marketing Marketing Marketing Marketing

Chulee “Pin” HarrisChulee “Pin” HarrisMarketing TechnicianMarketing TechnicianChulee “Pin” HarrisChulee “Pin” HarrisMarketing TechnicianMarketing Technician

CRADACRADACRADACRADAThomas Moreland Thomas Moreland DAADAA

Program AnalystProgram AnalystThomas Moreland Thomas Moreland DAADAA

Program AnalystProgram Analyst

Paula ReedPaula ReedExecutive AsstExecutive AsstPaula ReedPaula ReedExecutive AsstExecutive Asst

ExecutiveExecutive Support StaffSupport Staff ExecutiveExecutive Support StaffSupport Staff

Kim GarnerKim GarnerProgram Support Asst.Program Support Asst.

Kim GarnerKim GarnerProgram Support Asst.Program Support Asst.

Kate Baker Kate Baker DAADAA

Management AnalystManagement AnalystKate Baker Kate Baker DAADAA

Management AnalystManagement Analyst

Howard OwensHoward OwensPatent Advisor (PWA)Patent Advisor (PWA)Howard OwensHoward OwensPatent Advisor (PWA)Patent Advisor (PWA)

Sonya DomingoSonya DomingoLegal Instruments ExaminerLegal Instruments Examiner Sonya DomingoSonya DomingoLegal Instruments ExaminerLegal Instruments Examiner

Elizabeth SampsonElizabeth SampsonPatent Advisor (PWA)Patent Advisor (PWA)Elizabeth SampsonElizabeth SampsonPatent Advisor (PWA)Patent Advisor (PWA)

Albany, CAAlbany, CAAlbany, CAAlbany, CA Robin McCormick Robin McCormick Legal Instruments ExaminerLegal Instruments ExaminerRobin McCormick Robin McCormick Legal Instruments ExaminerLegal Instruments Examiner

Gernard LittleGernard LittlePatent AssistantPatent AssistantGernard LittleGernard LittlePatent AssistantPatent Assistant

Evelyn RabinEvelyn RabinPatent AdvisorPatent Advisor(NAA, MSA, & Biotech)(NAA, MSA, & Biotech)

Evelyn RabinEvelyn RabinPatent AdvisorPatent Advisor(NAA, MSA, & Biotech)(NAA, MSA, & Biotech)

Gail Poulos Gail Poulos AAAA

Supervisory Patent Advisor (SAA)Supervisory Patent Advisor (SAA)Gail Poulos Gail Poulos AAAA

Supervisory Patent Advisor (SAA)Supervisory Patent Advisor (SAA)

Kelli GanttKelli GanttPatent AssistantPatent AssistantKelli GanttKelli GanttPatent AssistantPatent Assistant

vacantvacantPatent AssistantPatent AssistantvacantvacantPatent AssistantPatent Assistant

Patent StaffPatent StaffPatent StaffPatent Staff

Peoria, ILPeoria, ILPeoria, ILPeoria, IL

Albert TsuiAlbert TsuiPatent Advisor (MWA & NPA)Patent Advisor (MWA & NPA)Albert TsuiAlbert TsuiPatent Advisor (MWA & NPA)Patent Advisor (MWA & NPA)

Randy Deck Randy Deck Patent Advisor (SPA & MWA) Patent Advisor (SPA & MWA) Randy Deck Randy Deck Patent Advisor (SPA & MWA) Patent Advisor (SPA & MWA)

Sheri WhitehurstSheri WhitehurstLegal Instruments ExaminerLegal Instruments Examiner Sheri WhitehurstSheri WhitehurstLegal Instruments ExaminerLegal Instruments Examiner

Robert JonesRobert JonesPatent AdvisorPatent Advisor(SAA)(SAA)

Robert JonesRobert JonesPatent AdvisorPatent Advisor(SAA)(SAA)

TTC StaffTTC StaffTTC StaffTTC Staff

Marcie Currie-GrossExtramural Agrmnts. Asst.Marcie Currie-GrossExtramural Agrmnts. Asst.

Annetta EbelharSecretaryAnnetta EbelharSecretary

Rob Griesbach DAA

BA, Tech Tran CoordinatorRob Griesbach DAA

BA, Tech Tran Coordinator

Dolores ShilkitusTech Tran Assistant Dolores ShilkitusTech Tran Assistant

Bryan Kaphammer DAA

NPA/SPA, Tech Tran CoordinatorBryan Kaphammer DAA

NPA/SPA, Tech Tran Coordinator

Don Nordlund DAA

SAA/MSA, Tech Tran CoordinatorDon Nordlund DAA

SAA/MSA, Tech Tran Coordinator

David Nicholson DAA

PWA, Tech Tran CoordinatorDavid Nicholson DAA

PWA, Tech Tran Coordinator

Jason BrayTech Tran AssistantJason BrayTech Tran Assistant

Vic Chavez DAA

NAA, Tech Tran CoordinatorVic Chavez DAA

NAA, Tech Tran Coordinator

Kristin KimballTech Tran Assistant Kristin KimballTech Tran Assistant

Thomas Valco DAA

Cotton Tech Tran & Education CoordThomas Valco DAA

Cotton Tech Tran & Education Coord

Renee Wagner DAA

MWA, Tech Tran CoordinatorRenee Wagner DAA

MWA, Tech Tran Coordinator

vacant vacant Tech Tran Assistantvacant vacant Tech Tran Assistant

Babette DavisSecretaryBabette DavisSecretary

Joe LipovskySRRC, Assoc. Tech Tran Coord.Joe LipovskySRRC, Assoc. Tech Tran Coord.

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ARS Decision-Making ARS Decision-Making PrinciplesPrinciples ARS conducts research to develop and ARS conducts research to develop and

transfertransfer solutions to agricultural solutions to agricultural problems of high national priority.problems of high national priority. Licensing policies are mission Licensing policies are mission driven.driven.

Research programs are designed with Research programs are designed with stakeholder input, and outcomes are stakeholder input, and outcomes are measured by positive impacts.measured by positive impacts. ARS ARS has a “market pull” orientation.has a “market pull” orientation.

A variety of tools are available for A variety of tools are available for partnering and technology transfer.partnering and technology transfer. Select the right tool for the job.Select the right tool for the job.

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ARS Policies and ProceduresARS Policies and ProceduresDocumented in P & P 141.2 (revision in Documented in P & P 141.2 (revision in

draft)draft)

Policy / Procedural Issues for Policy / Procedural Issues for APHISAPHIS

Need to develop generic documentsNeed to develop generic documents CRADAs, MTAs, CAsCRADAs, MTAs, CAs

Properly delegate signature Properly delegate signature authorityauthority CRADAs, MTAs, CACRADAs, MTAs, CA

Establish review & approval Establish review & approval processesprocesses Ethics clearanceEthics clearance Program alignmentProgram alignment Line management issuesLine management issues

Develop and deliver training --Develop and deliver training -- a a critically important processcritically important process

Policy / Procedural Issues for Policy / Procedural Issues for APHISAPHIS

Invention Disclosure Review Invention Disclosure Review Committee (?)Committee (?)

Define agency policy on Define agency policy on partnershipspartnerships Regulatory agency?Regulatory agency? Cooperators can pay travel?Cooperators can pay travel? Cooperators in APHIS labs?Cooperators in APHIS labs? No money CRADAs?No money CRADAs? Use of other cooperative research Use of other cooperative research

instruments?instruments? (e.g., 7 U.S.C. 3318(b)(e.g., 7 U.S.C. 3318(b)

Policy / Procedures Developed Policy / Procedures Developed by OTT for APHIS WSby OTT for APHIS WS

Resulted from joint Resulted from joint meetings with OTT meetings with OTT staff, WS management, staff, WS management, WS scientistsWS scientists

Provided some hard Provided some hard copies (administrative)copies (administrative)

Provided to scientists Provided to scientists on CDs with on CDs with hyperlinked hyperlinked documents & formsdocuments & forms

Provides basis for Provides basis for trainingtraining

Could be modified to Could be modified to serve all APHISserve all APHIS

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Mechanisms of Technology Mechanisms of Technology TransferTransfer

Publication Trade Publication Seminars / Workshops Field Days Release of Public Plant

Varieties Management of Intellectual

Property Rights (IPR) Research Partnerships

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Types of Tools Used in Types of Tools Used in Technology Transfer Technology Transfer

TransactionsTransactions Confidentiality Agreement (CA) Material Transfer Agreement (MTA) Cooperative Research and Development

Agreement (CRADA) Patent, PVPC License Agreement Trust Fund Cooperative Agreement Memorandum of Understanding (MOU) Non Funded Cooperative Agreement Partnership Intermediary Agreement

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Professional Services of ARS Professional Services of ARS OTT – Tech Transfer OTT – Tech Transfer

CoordinatorsCoordinators Training to all ARS scientists and Research Training to all ARS scientists and Research Leaders (w/ patent, licensing, marketing Leaders (w/ patent, licensing, marketing staff)staff)

Negotiation, review, approval, and Negotiation, review, approval, and management of CRADAs, Material Transfer management of CRADAs, Material Transfer Agreements, and Confidentiality Agreements, and Confidentiality AgreementsAgreements

Review of other partnership instruments for Review of other partnership instruments for implications to management of intellectual implications to management of intellectual propertyproperty

Assist in scheduling cooperator meetings; Assist in scheduling cooperator meetings; help develop Statements of Work (CRADA)help develop Statements of Work (CRADA)

Service to ARS Scientists, Customers, Stakeholders …

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Professional Services of ARS Professional Services of ARS OTT – Patent SectionOTT – Patent Section

Create, manage & convene Patent Review Create, manage & convene Patent Review Committees (e.g., Invention Disclosure)Committees (e.g., Invention Disclosure)

Advises scientists on strategy (often with Advises scientists on strategy (often with TTC, licensing, marketing)TTC, licensing, marketing)

Prepare, file, and prosecute U.S. patent Prepare, file, and prosecute U.S. patent applications, & process Plant Variety applications, & process Plant Variety Protection Certificate applicationsProtection Certificate applications

Coordinate cooperator-filed PVP and U.S. Coordinate cooperator-filed PVP and U.S. patent applicationspatent applications

Facilitate and direct foreign filings with Facilitate and direct foreign filings with contractorcontractor


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Professional Services of ARS Professional Services of ARS OTT -- LicensingOTT -- Licensing

Advises on intellectual asset Advises on intellectual asset management strategymanagement strategy

Negotiates licensesNegotiates licenses Files appropriate Federal Register Files appropriate Federal Register

notices of intent to license notices of intent to license Monitors for license complianceMonitors for license compliance Distributes royalties for the Distributes royalties for the

duration of the license (up to 20 duration of the license (up to 20 years)years)


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Professional Services of ARS Professional Services of ARS OTTOTT

-- Marketing-- Marketing Conduct targeted Conduct targeted marketing to marketing to private sector private sector companies by companies by technology categorytechnology category

““Tech Alerts”:Tech Alerts”: over over 3,000 subscribers 3,000 subscribers (large and small (large and small businesses, businesses, university university researchers, state researchers, state extension and extension and economic agencies)economic agencies)


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Professional Services of ARS Professional Services of ARS OTTOTT-- HQ-- HQ Coordination and monitoring of iEdison Coordination and monitoring of iEdison

database on invention disclosures made database on invention disclosures made by ARS (and CSREES) cooperators (Bayh-by ARS (and CSREES) cooperators (Bayh-Dole Act of 1980; provides additional Dole Act of 1980; provides additional metrics for GPRA, PART, BPI) metrics for GPRA, PART, BPI)

Annual Report to Congress through OMB Annual Report to Congress through OMB and Appropriations committees (metrics, and Appropriations committees (metrics, downstream outcomes & success stories)downstream outcomes & success stories)

Technology Transfer recognition through Technology Transfer recognition through the Federal Laboratory Consortium the Federal Laboratory Consortium (leadership; T2 award nominations)(leadership; T2 award nominations)


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Professional Services of ARS Professional Services of ARS OTTOTT-- HQ-- HQ Consultation with Office of National Consultation with Office of National

Programs on intellectual property issues Programs on intellectual property issues related to research program managementrelated to research program management

Provide guidance and consultation to Provide guidance and consultation to Secretary of Agriculture and Executive Secretary of Agriculture and Executive Branch on policies regarding intellectual Branch on policies regarding intellectual property management in agricultureproperty management in agriculture

Assist in negotiation with foreign Assist in negotiation with foreign governments and international NGO entitiesgovernments and international NGO entities

Coordinate interactions & activities of Coordinate interactions & activities of Partnership Intermediaries (econom. Partnership Intermediaries (econom. develop.)develop.)


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Models for Developing and Models for Developing and Transferring Technologies to the Transferring Technologies to the

Private SectorPrivate Sector

Background Invention(developed in USDA)

Seek PrivateSector Interest

For Commercialization

Marketing Section•Creates summary•Places on OTT website

LicensingSectionCorporate

response

Federal Register Notice

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The CRADA Model for Developing and The CRADA Model for Developing and Transferring Technologies to the Transferring Technologies to the

Private SectorPrivate Sector

Subject Invention(developed under CRADA)

CorporateResearch Need

ARS Scientist

Technology Transfer

Coordinator

Patent

Corporation negotiates license (no FR notice)

Cooperative Research & Development

Agreement (CRADA)

Manufacture &Market

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Avoiding “Nightmare” CRADAsAvoiding “Nightmare” CRADAs

CorporateResearch Need

ARS Scientist

Technology Transfer

Coordinator

DRAFT Cooperative Research

& Development Agreement (CRADA)

Review by Deputy Asst.

Admin.

• Careful review of Statement of Work (SOW) to ensure precise scope

• Check with Extramural Agreements Division to ensure that scientist does not have similar SOW in other Agreements, or other Bayh-Dole rights

• Consult with Office of National Programs

• Obtain Ethics clearance

CRADA Development and CRADA Development and Approval Process at ARSApproval Process at ARS

Scientist, Cooperator, & TTC* discuss potential CRADA & draft Statement of

Work and budget

Scientist immediately processes 425, 416/417

for Area / ONP approval

Approved Approved (see next slide)(see next slide)

Disapproved

Negotiation and CRADA development

ends*Technology Transfer Coordinator


TTC finishes negotiation with partner, prepares and submits final draft

CRADA to Deputy**, OTT through Area line management

Approved Approved (from previous slide)(from previous slide)

If Cooperator is a non-US institution, TTC* submits a

CRADA Opportunity announcement to Marketing and

sends a U.S. Trade Rep. notice to HQ; also review process for

compliance with Export Administration Regulations.

Scientist files ADODR Certification (ethics)

DisapprovedApprovedApproved

Identify suitable alternate ADODR or

PI (NPS, Area Office)

*Technology Transfer Coordinator** Deputy Assistant Administrator3


TTC* finishes negotiation with partner, prepares and submits final

draft CRADA to Deputy, OTT through Area line management

OTT (DAA**) creates final CRADA document; sends

Statement of Work and budget to NPL for approval

OTT-DAA (ADO) signs & forwards to

Cooperator *Technology Transfer Coordinator** Deputy Assistant Administrator

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Annual Report to Congress on Annual Report to Congress on Technology Transfer --- “Downstream Technology Transfer --- “Downstream

Outcomes”Outcomes”

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Our Newest Tool for Partnerships

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15 USC 371515 USC 3715 Partnership Intermediaries Partnership Intermediaries

Partnership Intermediary: An agency of a State or local government,

or a nonprofit entity that assists, counsels, advises, evaluates, or otherwise cooperates with small business firms or institutions of higher education, that need or can make demonstrably productive use of technology-related assistance from a Federal laboratory.

To provide services for the Federal laboratory that increase the likelihood of success in the conduct of cooperative or joint activities of such Federal laboratory.

Model of a Public/Private Partnership Model of a Public/Private Partnership for Commercialization of Research for Commercialization of Research

OutcomesOutcomes

Structural Assets and Financial Resources

T2

Intellectual Capital

IntellectualAssets

IntellectualProperty

HumanCapital

Complementary Assets

Dis

trib

uti

on

Cap

ab

ilit

ies

Pro

du

ct

Reg

istr

ati

on

Man

ufa

ctu

rin

g F

acilit

ies

Tech

nic

al Exp

ert

ise—

Pro

du

ct

Dev,

Scale

-up

, Q

C

Mark

eti

ng

an

d D

istr

ibu

tion

Cap

ab

ilit

ies

Pro

du

ct

Reg

istr

ati

on

Exp

ert

ise

Investm

en

t C

ap

ital

These can be facilitated by Partnership Intermediaries of ARS OTT (Technology-Based Economic Development entities)

CRADA

Adapted from Sullivan, P.H., Profiting From Intellectual Capital, John Wiley & Sons, New York, 2000.

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Summary of IssuesSummary of Issues Management of intellectual assets is Management of intellectual assets is

increasingly important to USDA customers and increasingly important to USDA customers and stakeholders, especially small U.S. businesses.stakeholders, especially small U.S. businesses.

For most of the transactions,T2 requires a long For most of the transactions,T2 requires a long view and a team approach with seasoned view and a team approach with seasoned professionals.professionals.

Signing a CRADA is an obligation to a future Signing a CRADA is an obligation to a future licensing negotiation by USDA, and the licensing negotiation by USDA, and the relationship will last long beyond the CRADA. relationship will last long beyond the CRADA.

Licenses and CRADAs (and the rights to IP) will Licenses and CRADAs (and the rights to IP) will make or break a public / private partnership; make or break a public / private partnership; thus, forming such relationship must be thus, forming such relationship must be deliberate, strategic, well planned, and nurtured.deliberate, strategic, well planned, and nurtured.

Attention to detail, processes, and training are Attention to detail, processes, and training are prerequisites for success.prerequisites for success.

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Richard J. Brenner, Ph.D.Assistant Administrator

Office of Technology Transfer5601 Sunnyside AveBeltsville, MD 20705

(301) 504-6905

Photo: Quiet Waters Park, Annapolis, MD (Joann Perkins)

The Office of Technology The Office of Technology Transfer is at your service….Transfer is at your service….

http://www.ars.usda.gov/Business/Business.htm

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Supplemental Information…Supplemental Information… Agreement types: Confidentiality, Material Agreement types: Confidentiality, Material

Transfer Agreement, CRADAsTransfer Agreement, CRADAs CRADA requirements & negotiationsCRADA requirements & negotiations Precautions against mixing IP rights and Precautions against mixing IP rights and

federal obligationsfederal obligations The Patenting Process, inventorship, and role The Patenting Process, inventorship, and role

of laboratory notebooksof laboratory notebooks Public / Private Partnerships: The Public / Private Partnerships: The

Agricultural Technology Innovation Agricultural Technology Innovation Partnership program (with Partnership Partnership program (with Partnership Intermediary Agreements (PIA))Intermediary Agreements (PIA))

ARS Technology Transfer: ERS Analysis of ARS Technology Transfer: ERS Analysis of ARS P&P.ARS P&P.

Examples of success storiesExamples of success stories

The following slides are provided as The following slides are provided as background information that may background information that may

stimulate questions, or may be stimulate questions, or may be referenced in support of answering referenced in support of answering

questions.questions.

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Confidentiality AgreementConfidentiality Agreement Used Used onlyonly when contemplating entering into when contemplating entering into

a partnership. Otherwise we do not disclose a partnership. Otherwise we do not disclose or receive confidential information.or receive confidential information.

Material Transfer AgreementMaterial Transfer Agreement Used when transferring Used when transferring ARS ARS

materials to outside partiesmaterials to outside parties which may be, will be, or are which may be, will be, or are patentedpatented

Used when transferring Used when transferring materials from outside materials from outside parties into ARSparties into ARS when when required by providerrequired by provider

TTC must be consulted for such TTC must be consulted for such servicesservices

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Confidentiality AgreementConfidentiality Agreement

Used Used onlyonly when contemplating when contemplating entering into a partnership. entering into a partnership. Otherwise we do not disclose or Otherwise we do not disclose or receive confidential information.receive confidential information.

Can be one way or two wayCan be one way or two way Protects patent rightsProtects patent rights ARS standard format may be ARS standard format may be

downloaded from the OTT websitedownloaded from the OTT website Handled at scientist levelHandled at scientist level Reported monthly by OTT to Area, Reported monthly by OTT to Area,

ONPONP

Guidance to scientists on use of agreements

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Material Transfer AgreementMaterial Transfer Agreement Used when transferring materials Used when transferring materials

which may be, which may be, or or will be, will be, oror are are patented, or when required by providerpatented, or when required by provider

ARS standard format may be ARS standard format may be downloaded from the OTT websitedownloaded from the OTT website

Reviewed to prevent “reach through” Reviewed to prevent “reach through” and other clauses that are contrary to and other clauses that are contrary to ARS policy; MUST adhere to Export / ARS policy; MUST adhere to Export / Deemed Export regulationsDeemed Export regulations

Handled by TTCHandled by TTC Reported monthly by OTT to Area, Reported monthly by OTT to Area,

ONPONP


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Cooperative Research and Cooperative Research and Development Agreement Development Agreement

(CRADA)(CRADA)A joint research and development A joint research and development

effort with at least one non-Federal, effort with at least one non-Federal, U.S. partner that has the possibility U.S. partner that has the possibility of developing to a commercial of developing to a commercial productproduct

A cooperative partnership that may A cooperative partnership that may lead to the development of lead to the development of intellectual property intellectual property


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Cooperative Research and Cooperative Research and Development Agreement (CRADA)Development Agreement (CRADA)

Benefits to Firms:Benefits to Firms: Access to ARS research capacityAccess to ARS research capacity First right to negotiate Exclusive License First right to negotiate Exclusive License

for Subject Inventions without FR noticefor Subject Inventions without FR notice Confidentiality (competitive advantage)Confidentiality (competitive advantage) Opportunity to compete in global marketsOpportunity to compete in global markets

Benefits to ARS:Results-Oriented Research/Impact

Market informationIdentification of LicenseeResources (For the Project)


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CRADA NegotiationsCRADA Negotiations

USDA May Provide Any of the Above Except Money

Firms May Provide:ExpertiseMaterialsEquipment

EmployeesMoneyFacilities


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CRADA PartnersCRADA Partners May be an individual company, group of May be an individual company, group of

firms, association, university or firms, association, university or combination of abovecombination of above

May include, but not be limited to, May include, but not be limited to, cooperation with another Federal agencycooperation with another Federal agency

ARS actively seeks CRADAs with small ARS actively seeks CRADAs with small and/or minority-owned businessesand/or minority-owned businesses

No need to “compete” for CRADAs, we No need to “compete” for CRADAs, we are free to choose the best partnerare free to choose the best partner

Developed by TTCsDeveloped by TTCs Cleared through line management and Cleared through line management and

ONPONP Reported monthly by OTT to Area, NPSReported monthly by OTT to Area, NPS


50

Rights to IP Depend On Source Rights to IP Depend On Source of Fundingof Funding

Intellectual Property (IP) issues

OwnershipOwnership results from results from inventorshipinventorshipEmploymentEmployment of inventors and/or source of inventors and/or source

of salary determine of salary determine rights ofrights of ownershipownershipCongressionally appropriated $$ Congressionally appropriated $$

disbursed outside USDA through disbursed outside USDA through extramural agreementsextramural agreements (Bayh-Dole Act)(Bayh-Dole Act)

Congressionally appropriated $$ for Congressionally appropriated $$ for intramural federal research intramural federal research (Fed. Tech. (Fed. Tech. Trans. Act)Trans. Act)

51

Rights to IP Depend On Source Rights to IP Depend On Source of Fundingof Funding

Intellectual Property (IP) issues

Mechanisms for ARS to offer IP to private sectorMechanisms for ARS to offer IP to private sector Background inventions (made by federal researchers Background inventions (made by federal researchers

under normal research authority)under normal research authority)If exclusive license is requested, ARS must publish If exclusive license is requested, ARS must publish

notice ofnotice of intentionintention of licensing in Federal Register and of licensing in Federal Register and address all objections.address all objections.

CRADA subject inventionsCRADA subject inventionsExclusivity allowed Exclusivity allowed without publishing notice of without publishing notice of

intent.intent.Up to 5 years confidentiality from FOIA (we rarely Up to 5 years confidentiality from FOIA (we rarely

grant more than 1). grant more than 1). NOTE: NOTE: do not hire univ. personnel to work on a do not hire univ. personnel to work on a

CRADA! This mixes Bayh-Dole IP rights with FTTA IP CRADA! This mixes Bayh-Dole IP rights with FTTA IP rights.rights.

52

Three Three “Subject Matter” “Subject Matter” CommitteesCommittees

Life SciencesLife SciencesChemical Chemical Mechanical and MeasurementMechanical and Measurement

New ARS National Patent New ARS National Patent Committees (Oct. 2007)Committees (Oct. 2007)

Each cover Each cover allall geographic Areas of geographic Areas of ARSARSEach Area will have at least 2 Each Area will have at least 2 members on each Committee, members on each Committee, rotate at 5 years.rotate at 5 years.

53

Advantages of ARS Advantages of ARS National Committees to National Committees to

AgencyAgencyUniform committee Uniform committee recommendations across the recommendations across the AgencyAgency

Committee recommendation Committee recommendation within three months of filing an within three months of filing an Invention Disclosure (meet Invention Disclosure (meet quarterly)quarterly)

Scientists and management Scientists and management notified of annual schedule at the notified of annual schedule at the beginning of each fiscal yearbeginning of each fiscal year

54

Patent Committee CriteriaPatent Committee Criteria

Q1: Is there current commercial interest in the invention or a high probability of commercialization in the future?

Q2: Is the magnitude of the market relative to the cost of commercialization sufficiently large to warrant a patent?

Q3: Would the patent likely play a significant role in transferring the technology to the user?

Q4: Would a patent be enforceable, i.e., is the invention drawn to, or does it employ a unique and readily identifiable material or device which could be bought or sold?

Q5: Is the invention of sufficient scope to justify patenting?

55

InventionDisclosureSubmitted

Approval

2 Weeks

Committee

2-3 Months

Application Preparation

1 Year

Prosecution

2-3 Years

Issue

2-3 Months

Appeals

3-5 Years

The Patenting ProcessThe Patenting Process

Years 1 2 3 4

56

PrecautionsPrecautions

Know the technology you are using:• If you use patented genes or patented

tools to insert genes, royalties to patent holders may result.

• In other words, your new “cheap and better” technology just got expensive for a commercial producer!

• But may help identify licensee of your invention.

ARS generally does not patent ‘research tools,’ but others do!

57

Due Diligence in Protecting Intellectual Due Diligence in Protecting Intellectual Property: Property: Inventorship & Laboratory Inventorship & Laboratory

NotebooksNotebooksOwnership of intellectual Ownership of intellectual

property is determined by property is determined by inventorship inventorship

An inventor must be able to An inventor must be able to documentdocument theirtheir contribution to contribution to “conception & reduction to “conception & reduction to practice” for at least one claim practice” for at least one claim in an allowed patentin an allowed patent

DocumentationDocumentation has strict legal has strict legal requirementsrequirementsSigned & witnessed lab notebook Signed & witnessed lab notebook

pagespagesConsecutive numbered bound Consecutive numbered bound

pages, single line through errors pages, single line through errors (deletions) in data(deletions) in data

58

Good Laboratory Good Laboratory Notebook PracticesNotebook Practices

ARS ARS Laboratory Laboratory Notebooks Notebooks are are bound bound notebooksnotebooks

AlwaysAlways

Use Official ARS Use Official ARS Laboratory Laboratory NotebookNotebook

(ARS FORM 1)(ARS FORM 1)

59

CRADAs: CRADAs: Active: 230Active: 230New: 69 New: 69 (record!)(record!)Amended: 76Amended: 76

Material Transfer Agreements: 884 Material Transfer Agreements: 884 (648 outgoing) (648 outgoing) (record!)(record!)

Invention Disclosures: 133Invention Disclosures: 133Patent Applications Filed: 114 Patent Applications Filed: 114

(record!)(record!)Patents Issued: 27Patents Issued: 27

Annual Report to Congress on Annual Report to Congress on Technology Transfer --- FY 2008 Technology Transfer --- FY 2008

MetricsMetrics

60

Annual Report to Congress on Annual Report to Congress on Technology Transfer --- FY 2008 Technology Transfer --- FY 2008

MetricsMetricsLicenses: Licenses:

Active: 315 ( ~130 with universities)Active: 315 ( ~130 with universities)New: 27New: 27Biological Materials: 24 (4 new)Biological Materials: 24 (4 new)

Licenses with products on market: Licenses with products on market: 112 112 (record!)(record!)(28 from university co-owned)(28 from university co-owned)~30 are plant materials (plant patent or ~30 are plant materials (plant patent or

Plant Variety Protection Certificate)Plant Variety Protection Certificate)Total Income: $3,953,415 Total Income: $3,953,415 (record!)(record!)

To Inventors: $756,458To Inventors: $756,458

61

Goals of Agricultural Technology Innovation Partnership Program (through PIAs)

To partner with selected economic To partner with selected economic development agencies to enhance development agencies to enhance the effectiveness of the ARS the effectiveness of the ARS technology transfer program and to technology transfer program and to expand its impactexpand its impact

To enhance the flow of ARS To enhance the flow of ARS technologies to small and expanding technologies to small and expanding businesses and to encourage businesses and to encourage technology-based economic technology-based economic developmentdevelopment

62

Goals of ARS Partnership Intermediaries

Provide complementary assets Provide complementary assets to ARS Office to ARS Office of Technology Transferof Technology Transfer Guide local / regional business with research needs to Guide local / regional business with research needs to

the appropriate ARS scientist across ARS (CRADA the appropriate ARS scientist across ARS (CRADA opportunities)opportunities)

Triage business plans of private sector to seek Triage business plans of private sector to seek “winners” as candidates for licensing / research “winners” as candidates for licensing / research partnerships with ARS partnerships with ARS

Acquire marketing assessments on ARS technologies Acquire marketing assessments on ARS technologies from 3from 3rdrd party sources (business schools, entrepreneur party sources (business schools, entrepreneur programs, angel investors, etc.) for targeted marketingprograms, angel investors, etc.) for targeted marketing

Coordinate “Technology Showcase” events to facilitate Coordinate “Technology Showcase” events to facilitate partnerships with private sector companies (TEDCO, partnerships with private sector companies (TEDCO, October 30, 2008 – Four Points Sheraton at BWI)October 30, 2008 – Four Points Sheraton at BWI)

63

Goals of ARS Partnership Intermediaries

Provide complementary assets Provide complementary assets needed by needed by private sector to succeed in private sector to succeed in commercializing federal inventionscommercializing federal inventionsAssist in accessing public / private fundsAssist in accessing public / private funds

SBIR proposalsSBIR proposalsAngel investors / state fundsAngel investors / state fundsManufacturing capacityManufacturing capacity

Manage their own seed/venture funds to Manage their own seed/venture funds to support CRADA and license partners of ARSsupport CRADA and license partners of ARS

Assist private sector in preparing license Assist private sector in preparing license applicationsapplications

64

Role of PIA PartnerRole of PIA Partner

Learn about ARS technologies available for Learn about ARS technologies available for partneringpartnering

Introduce businesses to ARSIntroduce businesses to ARS Point companies interesting in partnering with Point companies interesting in partnering with

ARS to complementary assets: VC, grant ARS to complementary assets: VC, grant opportunities, etc.)opportunities, etc.)

Provide services such as market analyses to ARSProvide services such as market analyses to ARS Work with ARS to host events to assist the Work with ARS to host events to assist the

business communitybusiness community Provide services to ARS partners such as help Provide services to ARS partners such as help

with business plans, licensing, etc.with business plans, licensing, etc.

65

Our Newest Tool for Partnerships

ARS signed its first formal ARS signed its first formal Partnership Partnership Intermediary Agreement (PIA)Intermediary Agreement (PIA) with the with the Maryland Technology Development Maryland Technology Development Corporation (TEDCO) to promote joint Corporation (TEDCO) to promote joint public/private research & technology-based public/private research & technology-based economic development with businesses in economic development with businesses in Maryland (September 28, 2007)Maryland (September 28, 2007) SRRC technology licensed to Maryland Co.SRRC technology licensed to Maryland Co. 3 CRADAs funded by TEDCO3 CRADAs funded by TEDCO ““Green Technologies” showcase (Oct. 30, 2008)Green Technologies” showcase (Oct. 30, 2008)

ARS has now established a second PIA with ARS has now established a second PIA with the Mississippi Technology Alliance (Dec. the Mississippi Technology Alliance (Dec. 15, 2008)15, 2008)

66

Culture of USDA: “Culture of USDA: “The The People’s Department”People’s Department”

Integration of T2 with research mission and priorities Integration of T2 with research mission and priorities ARS protects intellectual property ARS protects intellectual property principally when principally when

necessarynecessary to transfer technology (e.g., necessary for to transfer technology (e.g., necessary for further research investments)further research investments) Prefer public release of plant varieties for broad Prefer public release of plant varieties for broad

availability – examined on case-by-case basis (meets availability – examined on case-by-case basis (meets needs of a changing industry)needs of a changing industry)

Do not patent animals, nor research tools (could Do not patent animals, nor research tools (could change)change)

Goal of licensing is to facilitate technology transferGoal of licensing is to facilitate technology transfer Permit license-free research with any ARS technology Permit license-free research with any ARS technology

to promote further researchto promote further research

ARS Policy …ARS Policy …

67

Does ARS IP Management Promote Does ARS IP Management Promote or Inhibit Technology Transfer?or Inhibit Technology Transfer?

Intellectual property rights, such as patents, protect new inventions from imitation and competition. A patent’s major objective is to provide incentives for invention, sacrificing short-term market efficiency for long-term economic gains.

Conclusions …

The Question Posed by USDA’s Economic Research Service

68

More widespread use of patenting and licensing by ARS has not reduced the use of traditional instruments of technology transfer such as scientific publication

Conclusions …



69

As commercial partners gain experience with the technology and learn more about the market, mutually advantageous revisions to license terms can maintain the incentives through which private companies distribute the benefits of public research.

Conclusions …



70

Current Technologies In Successful Current Technologies In Successful Commercialization …Commercialization …

Preserving Preserving color, color, crispness, and crispness, and flavor of fresh flavor of fresh cut apples --- cut apples --- “Apple “Apple Dippers”® Dippers”® (Attila (Attila Pavlath / Pavlath / Dominic Wong, Dominic Wong, PWA; PWA; Mantrose-Mantrose-Hauser) Hauser) (license, (license, CRADA, CRADA, infringement)infringement)

71

100% natural 100% natural fruit bars fruit bars from fruit from fruit puree (Tara puree (Tara McHugh, McHugh, PWA; HR PWA; HR Mountain Mountain Sun; “Gorge Sun; “Gorge Delights”) Delights”) (license, (license, CRADA)CRADA)

Current Technologies In Current Technologies In Successful Successful

Commercialization …Commercialization …

72

Helping people Helping people with peanut with peanut allergies: allergies: “Sunbutter”“Sunbutter”® (Harmeet ® (Harmeet Guraya / Guraya / Isabel Lima, Isabel Lima, MSA; Red MSA; Red River River CommoditiesCommodities) (CRADA)) (CRADA)



73

Table grape Table grape varieties --varieties --(David (David Ramming, Ramming, PWA; PWA; California California Table Grape Table Grape CommissionCommission))

(license & (license & infringemeninfringement)t)



74

Human Human nutrition / nutrition / food food allergies / allergies / obesityobesity

Humane mouse Humane mouse bleeding bleeding lancet: lancet: “Goldenrod”® “Goldenrod”® (W. Golde / P. (W. Golde / P. Gollibin / L. Gollibin / L. Rodriquez, Rodriquez, NAA; NAA; MEDipoint, MEDipoint, Inc.)Inc.)

(CRADA)(CRADA)



75

George Inglett, George Inglett, MWAMWA(Oatrim, Z-trim, (Oatrim, Z-trim, Nutrim, Calorie-Nutrim, Calorie-

trim)trim)



76

Tom Casey, Mark RasmussenTom Casey, Mark RasmussenJacob Petrich (Iowa State U.), MWAJacob Petrich (Iowa State U.), MWA

(CRADA)(CRADA)



77

Biodegradable soy-Biodegradable soy-based hydraulic fluid based hydraulic fluid (Sevim Erhan, MWA; (Sevim Erhan, MWA; test with National Park test with National Park Service)Service)

Licensed Licensed exclusively exclusively to to Agrilube / Agrilube / Bunge (Feb Bunge (Feb 2006)2006)

First sale in First sale in March, March, 2006.2006.



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