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Introduction to the Introduction to the Offices of Biotechnology & Offices of Biotechnology & Business Development Business Development John L. Harb John L. Harb Director, Office of Biotechnology Director, Office of Biotechnology __________________________________ __________________________________ October 30, 2008 October 30, 2008
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Page 1: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Introduction to the Introduction to the Offices of Biotechnology & Offices of Biotechnology &

Business DevelopmentBusiness DevelopmentJohn L. HarbJohn L. Harb

Director, Office of BiotechnologyDirector, Office of Biotechnology____________________________________________________________________

October 30, 2008October 30, 2008

Page 2: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Our OfficesOur Offices

The The Office of BiotechnologyOffice of Biotechnology serves as the serves as the

technology transfer officetechnology transfer office

of the College.  The office facilitates of the College.  The office facilitates licensing of College technology to licensing of College technology to

industry and research collaborations industry and research collaborations between industry and faculty. between industry and faculty.

The The Office of Business DevelopmentOffice of Business Development is is focused on capturing and/or developing focused on capturing and/or developing novel or more aggressive novel or more aggressive technology technology

transfertransfer opportunities. opportunities.

Page 3: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

““Technology Transfer”Technology Transfer” DefinitionDefinition

““Technology transfer is the process of transferring Technology transfer is the process of transferring scientific findings from one organization to another scientific findings from one organization to another for the purpose of further development and for the purpose of further development and commercialization.” commercialization.”

– – Association of University Technology ManagersAssociation of University Technology Managers

Origin of FieldOrigin of Field Bayh-Dole Act 1980Bayh-Dole Act 1980

Encourages universities to patent and license the Encourages universities to patent and license the results of federally-funded research results of federally-funded research

Universities have rights in intellectual Universities have rights in intellectual property that resulted from federal research property that resulted from federal research fundingfunding

Commercialization of inventions benefit the Commercialization of inventions benefit the public good public good

Royalties are distributed to inventor and Royalties are distributed to inventor and reinvested for education and research reinvested for education and research purposespurposes

Page 4: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

University Technology University Technology TransferTransfer

Knowledge TransferKnowledge Transfer Publications & PresentationsPublications & Presentations CollaborationsCollaborations Material TransfersMaterial Transfers Sponsored ResearchSponsored Research ConsultingConsulting InventionsInventions LicensingLicensing

Page 5: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Your ResponsibilitiesYour Responsibilities

Acceptance Agreement Acceptance Agreement Abide by Einstein’s Patent PolicyAbide by Einstein’s Patent Policy Promptly disclose inventionsPromptly disclose inventions Assign ownership rights Assign ownership rights

Third-Party Agreement ObligationsThird-Party Agreement Obligations PublicationsPublications Use of MaterialUse of Material ConfidentialityConfidentiality ReportingReporting

Page 6: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Our ResponsibilitiesOur Responsibilities

Support Einstein faculty Support Einstein faculty researchersresearchers Facilitate technology transfer Facilitate technology transfer

relationshipsrelationships Protect the school and its faculty Protect the school and its faculty

membersmembers

Comply with obligations to Comply with obligations to sponsors and licensing partners sponsors and licensing partners

Page 7: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

ServicesServices

Invention DisclosuresInvention Disclosures Patent ManagementPatent Management

LicensingLicensing Material Transfer AgreementsMaterial Transfer Agreements

Agent Reagent ProgramAgent Reagent Program Industry-Sponsored Research Industry-Sponsored Research

AgreementsAgreements Grant required IP management languageGrant required IP management language

Resources and data sharing plansResources and data sharing plans Consulting AgreementsConsulting Agreements

Page 8: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Services (cont’d)Services (cont’d)

Confidentiality AgreementsConfidentiality Agreements Inter-Institutional AgreementsInter-Institutional Agreements Review IP languageReview IP language

Clinical Trial AgreementsClinical Trial Agreements Foundation/Non-Profit GrantsFoundation/Non-Profit Grants

Page 9: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Invention ProcessInvention Process

Invention Disclosure FormInvention Disclosure Form Details of invention and its Details of invention and its

reduction to practicereduction to practice Funding & material sourcesFunding & material sources Upcoming publicationsUpcoming publications Commercial contactsCommercial contacts

Patent CommitteePatent Committee Intellectual Property ProtectionIntellectual Property Protection

Page 10: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Licensing ProcessLicensing Process

Market, market, marketMarket, market, market Business discussions with Business discussions with

commercialization partnerscommercialization partners Confidentiality AgreementConfidentiality Agreement TermsTerms

License AgreementLicense Agreement Royalty is distributed in accordance Royalty is distributed in accordance

with Einstein’s Official Policy on Patents with Einstein’s Official Policy on Patents and Licensing Agreements (“Patent and Licensing Agreements (“Patent Policy”)Policy”)

Page 11: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Patent Policy Patent Policy DistributionDistribution

Net Royalty is distributed as Net Royalty is distributed as follows:follows: 1/3 – Inventors (personally)1/3 – Inventors (personally) 1/3 – Laboratory Research1/3 – Laboratory Research 1/3 – College1/3 – College

Page 12: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Material Transfer Material Transfer ProcessProcess

Various forms Various forms Incoming vs. OutgoingIncoming vs. Outgoing Academic vs. Industry PartnersAcademic vs. Industry Partners Human material?Human material? Hazardous material?Hazardous material?

[email protected] &[email protected] &

[email protected] [email protected]

Page 13: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Research ToolsResearch Tools

Disclose!Disclose! Online, interactive formOnline, interactive form

Review for commercial valueReview for commercial value Market to companies (“Agent Market to companies (“Agent

Reagent”)Reagent”)

High volume transfers High volume transfers repositories (mice, plasmids, etc.)repositories (mice, plasmids, etc.)

Page 14: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Industry-Sponsored Industry-Sponsored ResearchResearch

PI RolePI Role Develop Develop

Research PlanResearch Plan Develop BudgetDevelop Budget

Office RoleOffice Role Review BudgetReview Budget Negotiate Negotiate

AgreementAgreement

Points to remember:Points to remember: Overhead policy is consistent with NIH Overhead policy is consistent with NIH

raterate Involve us in the process early onInvolve us in the process early on Keep science and business separateKeep science and business separate

Page 15: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Hot Topics in Hot Topics in AgreementsAgreements

Publication RightsPublication Rights LiabilityLiability Intellectual Property RightsIntellectual Property Rights ConfidentialityConfidentiality

Page 16: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

ConsultingConsulting

PrivatePrivate Agreements Agreements MustMust be approved by: be approved by:

Department Chair Department Chair Dean (Office of Biotechnology)Dean (Office of Biotechnology)

Proposed guidelines and Proposed guidelines and suggestedsuggested languagelanguage Not in place of outside counselNot in place of outside counsel

Clauses of concernClauses of concern ConflictsConflicts

Prior rights & Einstein rightsPrior rights & Einstein rights Time commitmentsTime commitments

LiabilityLiability Distinction from research activitiesDistinction from research activities Student involvementStudent involvement

Page 17: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Office of Biotechnology Office of Biotechnology StaffStaff

John Harb, M.S.P.H.John Harb, M.S.P.H. DirectorDirector Assistant Dean, Scientific OperationsAssistant Dean, Scientific Operations

David Schoenhaut, Ph.D. David Schoenhaut, Ph.D. Assistant DirectorAssistant Director

Benjamin Neymotin, M.A.Benjamin Neymotin, M.A. Contracts and Licensing AssociateContracts and Licensing Associate

Page 18: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Office of Business Office of Business Development StaffDevelopment Staff

Richard Kosman, Sc.M.M. Richard Kosman, Sc.M.M. DirectorDirector

David Silva, Ph.D. David Silva, Ph.D. Senior Business Development Senior Business Development

AnalystAnalyst  

Janis Peck, M.B.A. Janis Peck, M.B.A. Business Development AnalystBusiness Development Analyst

Page 19: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Contact UsContact Us

Website: Website: www.aecom.yu.edu/biotechnologwww.aecom.yu.edu/biotechnologyy Forms & PoliciesForms & Policies News & PublicationsNews & Publications Contact InformationContact Information

Phone: 718-430-3357Phone: 718-430-3357 Office: Belfer Building, Office: Belfer Building, 99thth Floor Floor

Page 20: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Want to learn more about Want to learn more about IP?IP?

Join us…Join us…Tuesday, Tuesday, December 9December 9thth

Same RoomSame RoomDifferent time - Different time - NoonNoon

Guest Speaker - Guest Speaker - Kenneth P. George, PartnerKenneth P. George, Partner

Amster, Rothstein & Ebenstein LLP Amster, Rothstein & Ebenstein LLP (intellectual property law firm) (intellectual property law firm)

““Intellectual Property Overview Intellectual Property Overview for the Academic Researcher”for the Academic Researcher”

Page 21: Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October.

Thank YouThank You

Any Questions?Any Questions?


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