Partnering with the NIH: Technology Transfer. Why partner?

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1 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,

2 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) 2

3 Co-Development Agreements Research Collaboration Agreement CRADA License Option No Yes No Addresses Prospective Intellectual Property No Yes No Funds to NIH No Yes No Covers investigational data, drug, or device No Maybe Yes Addresses regulatory issues No Maybe Yes Clinical Trial Agreement 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 3

4 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/nonprofits 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 4

5 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 5

6 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 6

7 License Contractual transfer of rights and associated conditions to a technology Governed by federal statutes and regulations 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 7

8 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 8

9 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 9

10 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 C.F.R

11 Exclusive Licensing Process Applicant review of draft Execution (license agreement) Days/weeks/months Send draft license to applicant Consensus or Counteroffer Revised draft to applicant License application received -Evaluation of applicant and requested license 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 11

12 NIH Startup Licenses 1. Exclusive Evaluation License Agreement (EELA) 2. Exclusive Commercialization License Agreement (ECLA) Startup Exclusive Licenses Prenegotiated, Governmentcompliant 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* 12

13 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 2 nd 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 Contact Technology Transfer Office Licensing Opportunities Searchable database Technologies RSS Feed 13

14 Thank you for your kind attention 14