Eric F. Wagner Associate Director - Legal. Duke University Office of Licensing & Ventures eric.f.wagner@duke.edu

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1 Eric F. Wagner Associate Director - Legal Duke University Office of Licensing & Ventures eric.f.wagner@duke.edu

2 Some Quick Facts about Duke 6,526 undergraduates 8,220 graduate and professional students 1,779 faculty members, 1,116 in medicine 33,705 DU Health system employees $386M / year NIH research funding Duke Clinical Research Institute (DCRI) is the largest academic clinical institute in the world >$2B operating budget

3 Office of Licensing & Ventures Responsible for Patents Technology Licensing New Venture Development For all of Duke Medicine Nursing Engineering Arts & Sciences School of Environment

4 Office of Licensing & Ventures Who We Are: Rose Ritts Executive Director Licensing: 6 Associate Directors and 1 Licensing Analyst Patents: 1 Associate Director (Legal) and 2 Full Time Staff Agreements Manager Information Technology 3 Full Time Staff Finance/Administration 1 Director and 6 full time staff

5 Office of Licensing & Ventures Licensing Directors: Market Assessment of Invention Disclosures License/Option negotiations Pro-active Marketing Innovation Mining VC-funded Start-Ups Intellectual Property Assessment of Invention Disclosures** Legal: Intellectual Property Assessment of Invention Disclosures** Patent Filing & Management Government Compliance Finance: Invoicing Royalty Distribution

6 Mission: to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; Approved by the Duke University Board or Trustees October 1, 1994, and revised February 23, 2001 OLV Goal: to translate academic discoveries into commercial products that benefit society, impact public health, and improve the quality of life.

7 Typical Provisions Exclusive vs. Non-exclusive Fees: Cash or equity? Upfront Annual Milestone Recover of patent expenses Royalties Sublicensing Commercialization Patent Right Enforcement Retention rights Insurance/Government approval requirements Warranties Confidentiality Governing law Publications Export Control Indemnities Termination Compliance

8 Everything is negotiable.. except things that aren t Negotiable: Exclusive vs. Non-exclusive Fees: Cash or equity? Upfront Annual Milestone Royalties Sublicensing [Not-so] Negotiable: Retention rights Recovery of Patent Costs Commercialization Patent right enforcement Indemnities Termination Compliance Insurance/Government approval requirements Warranties Confidentiality Governing law Use of name Export Control

9 Retention of Rights: Duke maintains ownership of the patents/control prosecution Duke retains right to: practice IP for own educational, research, publication and clinical purposes right to publish (e.g., cannot do contract research) right to share with non-profit 3 rd parties and governmental agencies Compliance: For those patents covered by government funding, must comply with Bayh-Dole Act. Use of Name: Limited use Use approved in advance by Duke, must be factual and can not promote or endorse products/services

10 Commercialization: Duke requires that the Licensee use reasonable efforts to promote the commercialization of the IP No licenses for solely defensive purposes Enforce by requiring diligence requirements Automatic termination clause if cease/fail to commercialize Governing Law: North Carolina Export Control: Expect that Licensee will adhere to Export Control Act

11 Patent Enforcement/Indemnity: Require that Licensee must defend and/or settle at Licensee s expense any Third Party challenges Require that Licensee hold Duke harmless and indemnify from and against any and all damages, losses, liability and costs For infringement Licensee has the right to fight at own expense; if Licensee declines, Duke reserves right to sue at own expense Termination: Typically day termination notice Limited ability to cure License Agreement breaches Automatic termination for: failure to commercialize bankruptcy/insolvency Duke reserves right to terminate if Licensee commences a declaratory judgment action

12 Warranties: No warranties Confidentiality: Reasonable efforts No Trade Secrets

13 Fees: Upfront Milestone Back patent costs Royalties Minimum annual royalty Sublicenses: All sublicenses be at least as favorable to and protective of Duke as original license

14 Other Notes Do not offer preset terms for things that have not yet been invented (e.g., improvements are not automatically given to the original licensee) Typically hold the line on publication of information up to 90 days to allow for patenting, etc.

15 Contact Information for Office of Licensing and Ventures (919) Eric Wagner (919)

16 Thank You