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Partnering with the NIH: Technology Transfer

Jennifer Wong, M.S.Technology Development Coordinator

National Institute of Mental Health

Why partner?

• Enhance company’s portfolio

• “De-risks” developing a technology

• Collaborate with top scientists

• Conduct clinical trials at the world’s largest research hospital

• Dept. Health and Human Services is the world’s most innovative publicly funded research organization in 2017*

• Share information and materials

• License option for CRADA partners

• “Supermarket” for biological materials

* Ewalt, David. “The World’s Most Innovative Research Institutions – 2017” Reuters, published online March 1, 2017.

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Technology Transfer Goals

Movement of information, materials, and technologies from the research laboratories to commercial enterprises

To support further research and develop new products to improve public health

Technology Transfer Mechanisms

• Confidential Disclosure Agreement (CDA)• Cooperative Research and Development Agreement

(CRADA)• Research Collaboration Agreement (RCA)• Clinical Trial Agreement (CTA)• Patenting and Licensing• SBIR-Technology Transfer (SBIR-TT)

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Co-Development AgreementsResearch CollaborationAgreement

CRADA Clinical Trial Agreement

License Option No Yes No

AddressesProspective Intellectual Property

No Yes No

Funds to NIH No Yes No

Coversinvestigational data, drug, or device

No Maybe Yes

Addresses regulatory issues

No Maybe Yes

How to start a collaboration with NIH?

1. Find common research interest• NIH investigator

• Journal articles or conferences

• NIH websites• Institute or Center

• Technology Transfer

2. Negotiate an agreement with the technology transfer office

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Confidential Disclosure Agreements

• Specifies treatment of proprietary information• Term of confidentiality obligation

• Information clearly marked “Confidential”

• No license option

• Often first step in collaboration

CRADA

• Collaboration between Government and industry or academics/non-profits

• Government and CRADA partner(s) provide expertise, equipment or materials

• Company may provide money• Two unique advantages of a CRADA

– Company receives license option – NIH may receive funding

• CRADA and collaborations are independent of a SBIR/STTR

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Clinical Trial Agreements

• Specifies transfer and use of materials in research involving human subjects under a clinical protocol

• Investigational drug, biologic or device • Assigns responsibilities for addressing regulatory

requirements– Drug supply– IND filing and adverse events reporting to FDA– Study monitoring

• Data rights• Publications• No license option

Commercial Material Transfer Agreement

Distribution of materials to companies is under a royalty-bearing license unless…

– SBIR/STTR recipient

– Collaboration with NIH

– Replicate investigators’ findings in a published paper

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SBIR-Technology Transfer

• Contract or grant based on NIH inventions (varies by IC)

• Out-license of NIH inventions with SBIR funding

• Royalty-free internal use license for the SBIR-TT’s scope and term

• SBIR recipient works closely with the NIH inventor during the award period

• Commercial license is independent of SBIR-TT

SBIR-TT Collaborations

NIH labs can collaborate under many different formats

Company can exchange knowledge with the NIH researcher

Company can utilize fixed asset resources at NIH

Company cannot rely on the NIH lab to perform the majority of the effort being proposed for the SBIR contract

Company cannot fund work in NIH lab using SBIR money under a CRADA

Company cannot contact NIH researchers prior to SBIR contract award

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Contractual transfer of rights and associated conditions to a technology

Governed by federal statutes and regulations

License

Why License?

• Academic/Gov’t institutions typically don’t commercialize technology

• License provides permission to use IP, materials or other assets

• Companies may need it to attract other partners

• Financial consideration received for such grant of rights

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FAQs• Can I use a NIH developed technology

without taking a license?

• Do I need a license to a NIH developed technology before applying for a SBIR/STTR?

• Will a license increase my chances of getting a SBIR/STTR?

• What type of license do I need and how much does it cost?

Licensing Implications for SBIR/STTR applicant or awardee

• Potential to be “scooped” by competitors if technology is not licensed

• SBIR/STTR funds cannot be used to pay licensing royalties or CRADAs

• SBIR/STTR award is independent from commercialization license

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Which License?

Business Decision of Licensee

Types of Licenses

• Patent License Agreements• Exclusive or non-exclusive

• Start-up*

• Biological Materials• Commercial

• Internal Use

• Commercial Evaluation

• Software

* Participation varies by IC

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Typical Factors Influencing Royalty Negotiations

• Field of Use

• Stage of Development

• Type of Product

• Market Value of Product

• Uniqueness of Materials

• Scope of Patent Coverage

• Patent Term

• Market Timing

• “Content” in Final Product

• Public Health

NIH Licensing Principles

Grant only the appropriate scope of rights Fields of use and territory

Permit research uses

Preference for non or partial exclusivity

Global accessibility requirements

Statutes and Gov. regulations 35 U.S.C. 207-209 37 C.F.R. 404

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Exclusive Licensing Process

License application received

-Evaluation of applicant and requested license

Send draft license to applicant

Consensus or Counteroffer

Revised draft to applicant

Execution(license agreement)

Days/weeks/months

Applicant review of draft

Steps repeat until consensus reached

Publication of Federal Register Notice and public comment period

Remember CRADAs?• License option only applies to CRADA subject inventions

• CRADA partners can start license negotiations immediately

• Avoid Federal Register comment period

– Competitor’s objections

– Lengthy delays

• Separate license is required for non-CRADA subject inventions

• CRADA funds cannot be used to pay license royalties

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NIH Startup Licenses

1. Exclusive Evaluation License Agreement (EELA)

2. Exclusive Commercialization License Agreement (ECLA)

https://www.ott.nih.gov/nih-start-exclusive-license-agreements

Startup Exclusive Licenses• Prenegotiated, Government-

compliant licenses reflective of typical startup company situations

• Designed to reduce the time to execute agreement

• Drugs, vaccines, therapeutics, and certain devices

• Eligibility based on“5:5: 50 rule”< 5 years old< $5M in capital raised< 50 employees

*Startup licenses’ availability varies by IC*

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NIH Startup Licenses

EELA• $2,000 execution royalty

• 1 year term

• May convert to an ECLA at end of 1 year term (not automatic)

ECLA• No execution royalty

• Last to expire of patent rights

• Heavily deferred financial terms

• SBIR/STTR awardees and CRADA partners can have some financial terms waived

• Licensees are involved in patent prosecution

• Does not require 2nd public notice if converted from EELA in same FOU

How To Collaborate with NIH or License NIH Technologies

Collaboration– Search by scientific focus or investigator

https://irp.nih.gov/our-research/principal-investigators

– Contact Technology Transfer Officehttps://www.ott.nih.gov/tdcs

Licensing Opportunities– Searchable database

https://www.ott.nih.gov/opportunities

– Technologies RSS Feedhttp://www.ott.nih.gov/rss

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Thank you for your kind attention