2014 Healthcare Congress June 2014 Sara Nakashima Stanford University Office of Technology Licensing

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1 Transfer of Early Stage Medical Technologies 2014 Healthcare Congress June 2014 Sara Nakashima Stanford University Office of Technology Licensing

2 Starting Material: R&D Funding Science Vol 342, Nov 2013

3 U.S. Research Funding at Research Institutions AUTM U.S. Licensing Activity Survey FY2012

4 Stanford s Entrepreneurial Environment Federal government funding of research $664M = 76% of research funding at Stanford (FY13) Students key to technology transfer Largest grantor of graduate engineering degrees in US. Graduates come from all over the world and many stay. Entrepreneurship encouraged Clear conflict of interest policy, but faculty can start companies and consulting is allowed 1 day/week Positive feedback loop Lots of expertise, lessons and successes based on presentation from Stanford President John Hennessey

5 Stanford Biodesign biodesign.stanford.edu

6 Biodesign Process: Identify Invent Implement

7 Stanford Biodesign Entering the program and leaving it. Annals of Biomedical Engineering, Vol 41, No 9, Sept 2013

8 Stanford OTL s Mission To promote the transfer of Stanford technology for society s use and benefit while generating unrestricted income to support research and education.

9 Stanford OTL s Approach Do what s best for the technology. Plant a lot of seeds. Be flexible and creative.

10 Stanford OTL s Process

11 Tech Transfer: Invention Disclosure Who are the inventors and owners? What is the purpose of the technology? Is there ongoing research? Are there any third party rights? Upcoming public disclosures?

12 Tech Transfer: Assesment Is the market big enough? Is the invention evolutionary or revolutionary? What is the stage of development? What are the current and competing technologies? Is it a product or a company? What are the risks? 2006 cardiac rhythm monitor What is the inventor s track record?

13 Tech Transfer: Intellectual Property Can it be licensed without a patent? Is it patentable? Is it enforceable? How easy is it to invent around the patent? US or worldwide rights?

14 Tech Transfer: Marketing Reasons to market: Find a licensee Get feedback on a technology Mitigate possible conflict of interest issues

15 Tech Transfer: Selecting a Licensee Will this company make a good home for the technology? What is their plan for developing the technology? Uday Kumar irhythm Founder

16 Tech Transfer: License Terms Non-Financial Field of Use Exclusivity Territory Diligence Financial Issue Fee Equity Annual maintenance fees Earned Royalties Sublicensing Income Patent Reimbursement Milestones License Assignment Fee Stanford s sample agreements:

17 Tech Transfer: Commercialization Diligence with specific dates. Annual progress reports. Ability to terminate if licensee isn t being diligent. Audit rights.

18 Tech Transfer: Royalties AUTM U.S. Licensing Activity Survey FY2012

19 Stanford OTL s Process

20 Other Approaches Sponsored Research Minnesota: sponsored research agreement with preset licensing terms (one time fee of >10% of research funding or $15K, 1% ER after $20M sales) Auctions USC: $7.7M one time upfront fee for 11 digital multimedia patents Penn State: no broker, ~60 portfolios in acoustic, fuel cells and sensors, 2 sales and more pending, lots of publicity and input on older patents Express Licenses Univ of North Carolina: for UNC start ups favorable terms of 1% ER on FDA approved products, otherwise 2%. 0.75% at liquidation.

21 Thank You Sara Nakashima 1705 El Camino Real Palo Alto, California United States Come Visit!

22 Resources nts/otlstartupguide.pdf otl.stanford.edu Biodesign book

23 Stanford Resources ifarm

24 Stanford Inventions 1970 OTL Established 1971 FM Sound Synthesis ($22.9M) 1974 Recombinant DNA ($255M) 1981 Phycobiliproteins ($46.4M), Fiber Optic Amplifier ($48.4M), MINOS ($4.2M) 1984 Functional Antibodies ($425.7M) 1987 Selective Amplification of Polynucleotides ($28.1M) Discrete Multi-tone technologies for DSL ($29.7M) 1993 Microarrays ($2.1M), MIMO for Wireless Broadcast ($1.6M) 1994 In vivo Bioluminescent Imaging ($9.4M) 1996 Improved Hypertext Searching - Google TM ($339.2M) Data Visualization Software 2004 Refocus Photography ($324.6K) 2014 the next big thing??? *over 40+ years and 10,000 invention disclosures

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