Key Factors to Consider When Commercializing Technology Commercializing Commercializin Arizona Life Sciences Forum

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1 Key Factors to Consider When Commercializing Technology Commercializing Arizona Life Sciences Forum October 18, 2007 Phoenix, Arizona

2 Presenters Frank X. Curci, Partner Technology, Intellectual Property and Biotechnology Practice Areas Ron King, Ph.D., MBA Vice President Strategic & Business Partnerships Jennings, Strouss & Salmon Promenade Corporate Center N. Scottsdale Road, Suite 300 Scottsdale, AZ Tel: Translational Genomics Research Institute 445 North 5 th Street, Suite 600 Phoenix, AZ Tel: rking@tgen.org

3 Part I Introduction

4 Introduction Challenges faced by Research Institutions in commercializing i their inventions/technology Issues associated with licensing technology from a Research Institution to private sector life sciences/biotechnology companies.

5 Part II Managing The Gaps To Commercialization

6 A Non-Profit Research Institute Managing the Gaps to Commercialization Earlier Diagnoses, Smarter Treatments.

7 Discovery to Commercialization

8 Death Valley

9 Bridging the Financing Gap in Drug Development Basic Research Target/Lead Pre-Clinical Discovery Validation Development Clinical Development Approval and Marketing Traditional Philanthropy/ Government Venture Philanthropy Gap Funding Initiatives Venture Capital Big Pharma Private Equity/Public Markets FINANCING GAP High Risk Low

10 Challenges to Academic Technology Licensing Challenges to Academic Technology Licensing Too New Lack of Validation and Commercial Acceptance Too Early in Stage of Development Drug Target Patents Have Little Value to Industry Assays/Screens impossible to enforce New Chemical Entities Phase I data? How about toxicity and PD/PK profiles? ADME Package? Animal Models? SAR or Med Chem? Goal: To find creative ways to address these questions, add value to the IP and improve the chance of commercialization of our technologies

11 Requirements Needed to Accomplish the Goal of Technology Commercialization Applied Research on Basic Research Discoveries Proof-of-concept f tstudy and dprototype t Creation Translational Development of Asset Return on Investment Sound IP and Licensing Strategies

12 How are others bridging the GAP? The Florida High Tech Corridor Council office offers an Industry Matching Research Grant program - The program gives between 10 and 25 awards annually - Amounts are between $20 and 100K - Companies must match 3:2 for field-specific competition and 2:1 in open competition Three independent nonprofits formerly funded by the state as Innovation and Commercialization Centers 1. Enterprise North Florida Corporation 2. Enterprise Development Corporation of South Florida 3. Central Florida Innovation Corporation Three venture firms are certified under a $150M, 10 year Certified Company (CAPCO) program As a part of a $1 billion allocation to venture capital, the state pension fund has announced its intention to place up to $350M with funds that will include venture partnerships operating in Florida

13 How are others bridging i the GAP? Maryland is bridging the gap with its Technology Development Corporation(TEDCO) - State funded - Largest early-stage investor in country - Ranked first on the 2006 Entrepreneur Magazine s VC 100 list of most active early-and-seed stage investors in the nation 71 companies have received funding from TEDCO s Maryland s Technology Transfer Fund - Awards are typically a few hundred thousand

14 How are others bridging the GAP? Harvard s Technology Accelerator Fund Internal Fund-Philanthropic Evergreen Fund vs.classic VC-type Fund To bridge the gap between the academic lab and the clinic/market Create/purchase animal models of disease Toxicity/Pharmacodynamic & kinetic profiling Intermediate and Analog Manufacturing Proto-typing Draft Proposals and commercial development plans External review board (VCs, industry BD and scientists) $50k - 250k grants 1.5M a year CSO coordinating the Technology Development Projects Senior person for publicly traded pharma Detailed R&D plans with milestones Negotiates and executes contracts with CROs QuickTime and a TIFF (Uncompressed) decompressor are needed to see this picture.

15 With research and translational funding tight we need to be creative...

16 Part III Introduction to Technology Licensing

17 Introduction to Technology Licensing What is the Licensed Technology? Who is the Licensee? What is the Field of Use? How does Licensee plan to use the Licensed Technology? Exclusive versus Non-Exclusive Licensee s Milestones

18 Introduction to Technology Licensing, cont. Royalties and other consideration Improvements IP Representations and Warranties

19 Introduction to Technology Licensing, cont. Licensor = research institute, research university, it research hospital Licenseeee = private-sector life sciences/biotechnology company

20 Part IV What is the Licensed Technology?

21 What is the Licensed Technology? Intellectual Property that can be licensed includes: Patents Copyrights Trademarks Trade Secrets/ Know How

22 What is the Licensed Technology? Should precisely identify exact components of Licensed Technology that will be licensed to Licensee For patents: Make Invention Use Invention Sell Invention For copyrights: Copy/reproduce Work Distribute Work Make derivatives of Work

23 What is the Licensed Technology? In addition to a patented invention, may include: Licensor s Technology in pending patent applications Other Licensor know how that Licensee needs in order to properly use the patented Technology Software programs Databases Written materials, such as manuals Other confidential info of Licensor

24 Part V Who is the Licensee?

25 Who is the Licensee? Licensor s Viewpoint: Wants to precisely identify entities that t will be Licensee Licensor has right to limit the use of its Licensed Technology to known entities that will be bound by terms of the License Agreement This issue is important to Licensor because: Some Licensees mistakenly assume they can share license rights with the Licensee s subsidiaries/affiliates or even third party contractors

26 Who is the Licensee, cont. Licensee s Viewpoint: Particularly with worldwide exclusive license rights: need greater flexibility to create subsidiaries and other affiliates overseas to effectively commercialize the Licensed Technology. Not realistic to get Licensor s s prior written consent before using every affiliate entity

27 Part VI What is the Field of Use?

28 What is the Field of Use, cont. Will Licensee be permitted to use the Licensed Technology for all possible uses? Or, will Licensee be limited to a certain field of use? Licensor s Viewpoint: This is an important t issue since Licensor may want to license the Licensed Technology to another licensee in other fields of use Or Licensor may want to reserve certain uses for itself.

29 What is the Field of Use, cont. Licensee s Viewpoint: Broader field of use gives Licensee greater freedom to operate Broader field of use avoids potential confusion in future Any prohibitions on Licensee s use of the Licensed Technology even within the field of use? For example: Only for internal research by Licensee Only specific Licensee sites at which Licensed Technology can be practiced Only specific employees of Licensee can use the Licensed Technology

30 Part VII How Does Licensee Plan to Use the Licensed Technology?

31 How Does Licensee Plan to Use the Licensed Technology? Licensor s Viewpoint: Licensee must clarify how it will use Licensed Technology Will Licensee only use Licensed Technology internally to make a final product for use by end users? Or, will end users need access to Licensed Technology? Licensees often assume they can automatically sublicense their rights to a third party Licensor s attitude the terms and conditions of License were negotiated based on the financial and commercial status of Licensee and not upon an unknown sub-licensee Licensee should disclose to Licensor any intent by Licensee to engage g a third party to manufacture, distribute or sell products containing the Licensed Technology Thus, Licensor wants to know scope of any sub-licensee s rights (i.e., simply to manufacture, simply to distribute, etc.)

32 How Does Licensee Plan to Use the Licensed Technology?, cont. Licensee s Viewpoint: Research Institution i is only licensing i early stage discoveries that still require: Substantial additional R&D Extensive and expensive clinical trials Regulatory approvals in USA and overseas. Thus, difficult at this early stage to expect Licensee to precisely know: Full commercial utility and potential of Licensed Technology What other partners (i.e., subcontractors, t manufacturers, distributors, etc ) will be needed to effectively commercialize the Licensed Technology

33 Part VIII Exclusive Versus Non-Exclusive License and Territory

34 Exclusive/Non-Exclusive License and Territory Issue: Does Licensee want exclusive License to make, sell or otherwise use the Licensed Technology in specific territories? Licensor s Viewpoint: i Generally, Licensor should not grant exclusive rights (i.e. a worldwide de License ) unless Licensee can demonstrate it has capacity to maximize the commercialization of the Licensed Technology in that territory Otherwise, Licensor will not achieve maximum potential royalties

35 Exclusive/Non-Exclusive License and Territory, cont. Thus, Licensor should require Licensee to explain its business plan for maximizing commercialization of the Licensed Technology in order to justify an exclusive license Also, Licensor should reserve rights if it needs to use Licensed Technology in the exclusive territory

36 Exclusive/Non-Exclusive License and Territory, cont. Licensee s Viewpoint: Licensee deserves exclusivity because Licensee will be required to expend substantial money, time and resources for: Substantial additional R & D Extensive and expensive clinical trials Regulatory approvals in USA and overseas Anything less than exclusivity takes away Licensee s incentive to spend such money, time and resources Assuming the Research Institution and Licensee have an ongoing collaborative research relationship, it is unlikely Research Institution will license the Licensed Technology to any one other than Licensee.

37 Part IX Licensee s Milestones

38 Licensee s Milestones Licensor s Viewpoint: Minimum levels of performance should be established for exclusive and non-exclusive Licensees (often called Milestones ) An exclusive Licensee should have particularly strict Milestones since it is granted significant rights Licensor must understand Licensee s business plan for commercializing Licensed Technology to establish reasonable performance standards for Licensee Milestones may be in terms of: minimum Sales capturing a percentage of market share minimum Royalties

39 Licensee s Milestones, cont. Licensor usually wants Licensee, at a minimum, to use best efforts to commercialize Licensed Technology If a Licensee cannot meet the Milestones, Licensor often wants right to: Terminate the License With regard to exclusive Licensees, either termination or convert into nonexclusive License

40 Licensee s Milestones, cont. Licensee s Viewpoint: Because Research Institution tut is only licensing early stage discoveries that still require substantial R & D clinical trials regulatory approval in USA and overseas, it is premature to formulate meaningful monetary or market share Milestones Licensee may be agreeable to Milestones that address: dates for regulatory approval dates for first commercial product

41 Licensee s Milestones, cont. Licensee may also be agreeable to general duty to use: good faith efforts or commercially reasonable efforts

42 Part X Royalties and Other Consideration

43 Royalties and Other Consideration The Royalties that Licensee will pay Licensor can be structured in many ways: Upfront Royalties (similar to a down payment ) Ongoing Royalties that often are a percentage of net sales of products containing the Licensed Technology Could require Licensee to pay minimum ongoing g royalties regardless of the level of sales Licensor could obtain an equity interest in the Licensee

44 Royalties and Other Considerations, cont. Particularly if Royalties are based on sales of products by Licensee: Licensor usually requires auditing rights to allow Licensor to monitor Licensee s compliance with terms of License Agreement

45 Part XI Improvements

46 Improvements Issue: Does Licensee have right to develop improvements, or derivatives of, or other enhancements to, the Licensed Technology (collectively Improvements )? Who owns Improvements? Licensor s Viewpoint: i Improvements to Licensed Technology made by Licensee: Licensor should own these because Licensee would not have access or right to use the Licensed Technology but for the License Agreement What about Licensee s s right to use these Improvements? Licensor often agrees to incorporate these into the License Agreement

47 Improvements, cont. Licensor s Viewpoint (cont.) Improvements to Licensed Technology made by Research Institution/Licensor: these should be OUTSIDE scope of Licensed Technology Licensee needs separate license to use these types of Improvements Otherwise patent creep

48 Improvements, cont. Licensee s Viewpoint: Improvements to Licensed Technology made by Licensee: Licensee should retain ownership due to substantial money, time and resources it has spent on additional R & D What about Licensor s right to use these Improvements? Licensee often resists granting Licensor many rights other than giving the Research Institution a noncommercial internal research license Why? Licensee does not want Improvements to get to its competitors

49 Improvements, cont. Licensee s Viewpoint (cont.) Improvements to Licensed Technology made by Research Institution/Licensor: Licensee usually wants some right of first refusal to gain licensing rights to use these Improvements Why: These Improvements will enhance Licensee s ability to maximize the commercialization of the core Licensed Technology

50 Part XII Intellectual Property Representations and Warranties

51 Intellectual Property Representations and Warranties Licensee s s Viewpoint: Licensee needs some assurances that Licensor either owns or controls all IP rights in the Licensed Technology Licensee also wants assurances it will not be sued for patent, trademark or copyright infringement as a result of using the Licensed Technology

52 Intellectual Property Representations and Warranties, cont. Licensee s Viewpoint, cont. Licensee s s main concern relates to who owns the patent rights General rule under US Patent Law: Inventor (i.e., researcher) is deemed Owner Thus, as general rule, Inventor(s) must assign to employer, in writing, the invention to transfer ownership to employer Signed writing Need specifically to identify the invention Without a signed written assignment of patentable invention: Employee retains ownership of invention Employer may only get shop rights (royalty-free license)

53 Intellectual Property Representations and Warranties, cont. Licensee s Viewpoint, cont. If inventor is not employee but third party contractor Absent a signed written agreement to the contrary, third party retains ownership of invention No Shop Rights In the context of a Research Institution and its researcher, courts typically look at these factors: Did a contract exist? Fact specific General employment agreement plus notification or awareness of Research Institution s IPR Policy will be evaluated by court Was sufficient consideration given for assignment of invention?

54 Intellectual Property Representations and Warranties, cont. Licensor s Viewpoint: Research Institutions (as Licensor) are typically reluctant to give private-sector licensee broad IP representations and warranties (and the supporting indemnification) such as: patent resulting from Research Institution s discovery will not infringe IP of third parties validity of patent Research Institution s theory: Not in the business of commercialization After license is granted, Research Institution cannot sustain long term risks associated with these representations, warranties and indemnifications Thus, Research Institution (as Licensor) usually wants to give minimal reps/warranties related to IP

55 Compromise IP Representations/Warranties Reasonable Compromise: Due diligence by Research Institution Research Institution can demonstrate its researchers have assigned the IP to the Research Institution Research Institution can demonstrate other internal processes as part of invention disclosure Research Institutions i often consider simpler representations and warranties: best of knowledge qualifiers Research Institution tion has right to enter into Agreement Research Institution has right to grant the License

56 Ron King, Ph.D. MBA Dr. King is currently the Vice President of Business and Strategic Partnerships at The Translational Genomics Research Institute (TGen). His primary responsibilities include alliance management, business development, and technology commercialization. Prior to joining TGen, Dr. King was the Deputy Scientific Director and Director of Technology Transfer at the National Human Genome Research Institute of the National Institutes of Health. Dr. King was responsible for managing multiple technology programs associated with the Human Genome Project and over 300 research scientists. Dr. King has extensive public and private sector experience in academia, government, and industry. Dr. King holds a Ph.D. in Biochemistry and Pharmacology from the University of California, Los Angeles, and an MBA from Arizona State University.

57 Frank X. Curci, Esq. i t Mr. Curci is a Member (Partner) of Jennings, Strouss & Salmon in the Intellectual Property, Technology and Biotechnology Practice Groups. Frank represents clients in domestic and international intellectual property and technology matters. He advises entities in many technology sectors, including biotechnology, life sciences, medical device, semiconductor, software, and other technology companies, and universities/research institutes. Frank counsels universities/research institutes and private sector technology companies concerning research collaborations, sponsored research, material transfers, and other technology transfer matters. He also represents technology companies in their participation in technology standards-setting organizations and other multi-party technology collaborations and consortia. Since January 1996 he has been an Adjunct Professor of Law teaching intellectual property courses at Arizona, California and Oregon Law Schools. He is currently an Adjunct Professor at the Sandra Day O Connor School of Law at Arizona State University, teaching High Technology Licensing. He previously taught at the University of the Pacific, McGeorge School of Law in Sacramento, California, and at Lewis & Clark Law School in Portland, Oregon where he taught International Intellectual Property Law and other intellectual property courses. Frank was a visiting attorney at a Tokyo, Japan law If you would like more information or assistance, please contact Frank X. Curci at or him at fcurci@jsslaw.com Admitted to practice in Arizona, New York and Oregon. firm in the early 1990s and his practice has had an international focus since that time. Frank writes and lectures on domestic and international intellectual property and technology issues. This information is intended for general information purposes only and not as specific legal advice. You are urged to consult an attorney concerning your situation and any specific legal l questions you may have All Rights Reserved.

58 Key Factors to Consider When Commercializing Technology

59 Presenters Carlos Encinas, MBA, PhD Director of Technology Transfer Office Ron King, Ph.D., MBA Vice President Strategic & Business Partnerships Cedars-Sinai i Medical Center Translational Genomics Research Institute Manoja Ratnayake Lecamwasam, Ph.D, Director of the Office of Intellectual Innovation Network Catholic Healthcare West St. Joseph s Hospital & Medical Center Romy Schlecht, Esq. General Counsel Arizona Technology Enterprises

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