Meetings

LES 2008 Annual Meeting Global Excellence in Licensing and Acquisition Through Certification October 19-23, 2008 Gaylord Palms Resort and Convention Center Orlando, FL

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Info: Weather and Dress Transportation Discount Disney Tickets Speakers Only: Information Workshops MONDAY, OCTOBER 20, 2008 • 2:00 p.m. - 3:15 p.m. WORKSHOP SESSION 1 1-CEM-1: Perspectives, Issues and Options for Dealing with Patent Litigation All Levels This session deals with the reality that commercialization of R&D can lead to patent infringement and ultimately to litigation. Licensing professionals are likely to encounter situations of patent litigation. The session will focus on educating the attendees through real life experiences and is meant to reduce or avoid the burden, costs, and stress associated with patent litigation. The session begins with a patent attorney describing some historical aspects to patent litigation – providing the attendees with the recent trends in patent litigation, as well as the most recent key changes in laws and approaches. From there the attendees will hear a first person business case on a patent litigation case – topics here are the pitfalls and lessons learned with a special focus on a collaborative or non-litigious outcome. The third speaker will discuss using third party experimentation and expert witnesses to prepare for, or prevent litigation. It will end with Q&A. William Fuller, Director, Business Development, Akron Polymer Systems, Inc. Michael Marcin, Partner, Fay Kaplun & Marcin, LLP 1-HEA-1: Performing Great Music in Pharma Corporate Development Intermediate Just as extraordinary symphony music can only occur if all sections of the orchestra are outstanding, pharmaceutical company growth can best occur if all corporate development activities are synchronized and optimized – licensing at all stages of development, co-promotion, product acquisition, company acquisition, alliances, etc. This workshop explores two case studies, Abbott and Eisai, which are amongst the companies that used most or all forms of corporate development. Both companies prospered, even through the last difficult decade, as a result of bold deal-making. Abbott acquired Knoll and KOS, while at the same time it continued to in-license and/or co-promote important products across several therapeutic areas. Eisai expanded outside its home market through a combination of successful co-promotion of its lead products in the USA and Europe (Aricept and Aciphex), product acquisitions (Ligand) plus its recent blockbuster acquisition (MGI Pharma). These success stories and several others will be reviewed in this workshop, which is designed as a macro view of the use of many, if not all corporate development activities, instead of an in-depth analysis of individual deals. William Mattson, Chairman Emeritus, The Mattson Jack Group John Poulos, Group Vice President, Licensing and New Business Development, Abbott Laboratories Alexander Scott, Vice President, Global Pharma Business Development, U.S., Eisai Corporation of North America 1-HEA-3: Negotiating for Alliance Success All Levels A workshop on negotiating from the alliance management perspective. The key issue is how to get the best deal for your company and ensure that the negotiations jointly support alliance success. The session will discuss successful strategies for deal negotiators and deal implementers to help go beyond "Yes" to implementing the deal. Illustrative examples of behaviors and tactics used in negotiating for implementation will be discussed. Jeffrey Brennan, Vice President, Business & Commercial Development, Targacept Mark Gordon, Partner, Vantage Partners John Reid, Director, Global Alliance Management & CNS/Pain, AstraZeneca 1-HEA-4: Strategic Bio-Pharma Deal Making: Has Alternative Financing Come of Age? Deal flow is a vital component in all companies both large and small. Business strategy drives the need for select deals but access to appropriate financing can often derail the effort before it can gain traction. Companies have always looked to the debt and equity markets to satisfy their need for capital but in recent years an alternative source of financing is getting attention. Interestingly, this is capital is derived from the company' s existing or projected assets in the form of royalty monetization and product revenue interest. Given the complexity and nuances of today' s capital markets and the varying risk tolerance of its multiple players, the use of alternative financing should be an option worthy of consideration by any company facing the need for additional capital. The structuring flexibility afforded by non-dilutive financing may even make deals happen that otherwise would not. This workshop will feature two healthcare deal case studies that exemplify the creativity and value creation made possible through the use of both revenue and royalty interest structures. Featuring recent transactions that bring both the company and financial decision makers to the podium, you will have the opportunity to hear first hand what was done, why it worked and whether you can apply it to your next transaction. John R. Leone, Partner, Paul Capital Partners Mark Nawacki, Vice President, Business and Corporate Development, Paladin Labs Inc. Joshua Salisbury, Managing Director, Healthcare Funds, DRI Capital 1-HTS-1: Should We Sell, License or Spin Off? Intermediate/Advanced Multiple tools are available to corporations seeking to monetize intellectual property. In this session we will explore four main approaches for monetizing intellectual property: intellectual property sales, mergers & acquisitions, licensing, and spin-offs. We will take a practical approach to discus the structure and benefits of each approach and its application, as well as the interplay between the approaches. We will also examine real-world examples to understand how a corporation can choose the best tools to monetizing its intellectual property. Brian Sagi, President & Chief Executive Officer, Cerian Technology Ventures, LLC 1-HTS-2: Issues In Open Source Licensing Implications of GPLVersion 3 Intermediate The Open Source movement is designed to promote innovation by allowing the sharing and use of source code. GPL Version 2.0 however contains no explicit patent license—meaning that a software developer can release software under GPL 2.0 for which it held a patent, and there was no requirement that a license to those patents be granted to the recipient of the software. § 11 of GPLv3, however, grants an explicit patent license to the recipients of all GPLv3 works. Further, the license commits patent owners to granting licenses to both current and future patents—and, GPLv3 provides a " patent retaliation clause" in § 10 such that if any licensee tries to use a patent suit to stop another user from exercising those rights, their license will be terminated. GPL 3.0 also attempts to prevent cross-licensing agreements like the recent Microsoft-Novell deal by granting third-party rights under the license. Previously, GPL 2.0 did not deal with such third-party beneficiaries to software licenses. Now, GPL 3.0 extends rights to third-parties under such blanket licensing agreements in § 11. Moderator: Jon Grossman, Partner, Dickstein Shapiro LLP Doug Copland, Partner, BLG Canada Hon. Suzanne Nussbaum, Barrister and Solicitor, Impartia Brad Olson, Patent Attorney, Dickstein Shapiro LLP 1-HTS-3: Best Practices: Alliances in the Semiconductor Industry Intermediate This session will highlight the importance and the need for alliances and joint ventures in the semiconductor industry. So the question is why alliances? For years many companies in the semiconductor industry have been involved in setting up these partnerships; some successful, some not so successful. The importance for companies to focus on their core competencies is more noticeable today than several years ago and thus the need for alliances is growing as the industry continues to change. Companies like IBM, Infineon, Sony, Freescale have all been and continue to be involved in alliances. So what have they learned? With years of experience and first hand knowledge our guest speakers will highlight the benefits of alliances, share how to find the right partner(s), discuss how to structure such agreements to ensure all conditions are covered, identify potential pitfalls/common mistakes people have made in the past and share lessons learned. Kevin Hutchings, Vice President, Alliances, IBM Technology and Intellectual Property Abdullah Rahal, Senior Consultant Profesional Services, Semiconductor Insights 1-HTS-4: Global IP Transactions Case Studies Novice/Intermediate Global IP Transactions Case Studies This session will include an in-depth review of 3 recently completed, global IP-based transactions by experienced IP professionals. The case studies will include the following: 1) Technology Licensing to Mobile Phone Industry Case Study (Microsoft) 2) IP Licensing in Technology deals (Intel Corporation) 3) Patent Acquisition Case Study (IPotential). Each speaker will provide an overview of the transaction and then discuss their experience on the deal including lessons learned from an IP perspective. Joe Chernesky, President & Chief Operating Officer, IPotential Pamela Hayes, Director, IP Licensing, Intel Corporation Joy Murray, Microsoft Corporation 1-IUGI-1: Evaluating and Valuing Inventions: What is the Difference? Novice/Intermediate Some of the gating techniques that businesses use in their research management are the same gating techniques that universities use when they have an invention disclosure show up on their doorstep. Remember, the TTO has a few licensing professionals that must deal with a breath of inventions across all scientific disciplines. Early stage invention evaluation is usually more qualitative than quantitative. In evaluating a university invention, companies need to understand that these are the 5 factors that are evaluated by the TTO: Invention Novelty Risk Analysis; Technology Risk Analysis; Market Risk Analysis; Competitive Risk Analysis and University Inventor(s)' s attitude. Valuation Standard valuation techniques for intellectual property assets (IP) are Cost Approach, Market Approach, Relief from Royalty Approach, and Income Approach. They must take into account the early stage of discoveries from universities. Moderator: Michael Martin, President, TechTransfer Associates, Inc. Richard Sheehan, President, Technology Resource of the South East Joe Walker, President, eZassi Medical Innovations 1-IUGI-2: The Patent Reform Storm: Lessons Learned One Year Later Intermediate The past year has seen considerable change in the patent landscape, with the U.S. Supreme Court issuing far-reaching opinions impacting patenting and licensing practices, and Congress proposing patent reform legislation to overhaul the patent system. In addition, the USPTO has also tried to enact major patent rule changes to address the ongoing problems of patent pendency and patent quality. The USPTO' s new rules are so controversial that their implementation was stopped by a Federal Court lawsuit in October 2007, and the status of these new rules remains in limbo. This perfect storm of patent reform affects academia/government labs and industry differently. Savvy licensors and licensees must understand the changing patent landscape to ensure optimal patent coverage for effective licensing transactions. A panel of patent and licensing experts will examine the effects patent reform has had thus far on patenting and licensing practices from the perspectives of small and large corporations and academia/not-for-profits. Speakers will discuss lessons learned by industry and academia as well as strategies to ensure successful patenting and licensing going forward in view of the still-evolving patent landscape. David Dykeman, Shareholder & Patent Attorney, Greenberg Traurig LLP Elaine White, Vice President, Business Development, Foresight Science & Technology 1-LGL-1: Top 10 Court Decisions of 2008 Affecting Licensing Intermediate This workshop will identify and discuss the top ten court decisions issued since the last annual meeting affecting licensing. The workshop will summarize the facts of each case, explain the legal holding/ruling, and discussthe implications for licensing. Russell Levine, Partner, Kirkland & Ellis LLP 1-BMD-1: Securing Patent Protection in the Biomedical Device Field – Best Practices Intermediate This workshop will discuss what it takes to secure patent protection in the biomedical device field. The session is directed towards innovators and business professionals and will provide practical strategies designed to increase the prospect of obtaining patent protection for biomedical device innovation. Best practices from the laboratory to the boardroom will be discussed in the context of recent developments in patent law and in the United States patent office. Roger Hahn, Patent Attorney, Hahn & Voight Law Offices PLLC Timothy Squire, Intellectual Property Lawyer, Lang Michener LLP Stacy Taylor, Partner, DLA Piper US LLP 1-VAL-1: Licensing in the Presence of Technological Standards All Levels This workshop will discuss issues arising from licensing in the presence of technological standards. In particular, it will discuss the impact of RAND/FRAND commitments on license terms. It will also include a discussion of the use of mechanisms such as patent pools to address licensing issues arising in a standards context. Finally, it will provide a description of publiclyavailable information regarding royalty rates for technology incorporated in standards. John Browning, Analysis Group, Inc. Mark Ford, Wilmer Cutler, Pickering, Hale & Dorr Carla Mulhern, Managing Principal, Analysis Group, Inc. Cynthia Vreeland, Vice Chair, Intellectual Property Litigation Practice Group, WilmerHale LLP 1-STR-1: Private Equity Firms: Friends or Foes? Private equity firms have competed with strategic buyers for several specialty pharmaceutical companies. This panel updates us on the state of the private equity industry and its evolving investment criteria. As debt becomes less available, will the private equity industry gain an appetite for higher risk investments in the biopharmaceutical industry? Moderator: Mark Speers, Partner and Managing Director, Health Advances LLC Geoff Lieberthal, Texas Pacific Group MONDAY, OCTOBER 20, 2008 • 3:45 p.m. – 5:00 p.m. WORKSHOP SESSION 2 2-CP-1: Cargill' s Successful Customer Partnership Efforts All Levels Learn how to deliver successful solutions to multiple same industry customers while maintaining, growing, and leveraging an intellectual asset portfolio. Cargill has been able to successfully leverage its intellectual assets with customer partnership while satisfying the customer' s concerns for maintaining a competitive advantage over their rivals who are also customer partners of Cargill. Sue Jacobson, Sr. Intellectual Property Manager, General Mills Technology Center Edward Levine, Senior IP Attorney, Cargill Inc. Gordon Petrash, Director, IAM Center of Expertice, Cargill 2-HEA-5: The Art of Keeping it Together: Problem Solving during Organon' s Asset Acquisition of Kadmus Pharma Intermediate This workshop will focus on the solutions to specific problems encountered by Organon and Kadmus Pharmaceuticals relating to Organon' s acquisition of Kadmus Pharmaceuticals' FAAH (Fatty Acid Amide Hydrolase) assets. In what has been come a more common type of transaction, the acquisition of the assets was structured with an upfront payment along with down-stream success-based payments to Kadmus. Not quite as common, however, the transaction also entailed the effective dissolution of Kadmus. Some of the specific problems encountered in the transaction that will be presented and discussed with focus on (1) Organon' s desire not to acquire intangible assets within the U.S.; (2) ensuring effective technology transfer by a short-term acquisition of tangible assets (the facility, equipment, and personnel); and, (3) Protecting the value of reps and warranties when the acquired company no longer exists post-transaction. In addition, while finalizing contract discussions, Organon was itself acquired by Schering-Plough. Jeff Parrott, Former Vice President, Business Development, Kadmus Pharmaceuticals Fernando Salles, Senior Director, Global Strategy & Portfolio Management, Organon International, a part of Schering-Plough Patrick Walsh, Former Chief Executive Officer, Kadmus Pharmaceuticals 2-HEA-6: Non-verbal Communication during Negotiations -What Might I BeMissing or Telegraphing? Intermediate The percentage of face-to-face interactions during any typical licensing transaction has decreased substantially over the years; this makes the few instances where it does occur that much more important. A tremendous amount of research over the last thirty years has proven that people' s gestures often give away their true intentions. Yet most of us don' t know how to read body language–and don' t realize how our own physical movements speak to others. Today' s successful licensing professional needs more than just communication skills; he or she also needs the ability to interpret nonverbal signals that we all display. In negotiating a deal, one makes calculated risks and decisions based on the best information available. It would be helpful to know what the other person is thinking. Are they telling the truth? Are they bluffing or holding back? Licensing professionals who understand the basics of body language and how it exposes and influences attitudes, actions, and outcomes can have an edge during a negotiation. Anjan Aralihalli, Director, U.S. Business Development, Sanofi-Aventis Pharmaceuticals Christine Mayer, Senior Vice President, Business Development Services, Biovail Pharmaceuticals, Inc. 2-HEA-7: All these Deal Tools and Comparables, but All We Need is a Napkin! Novice/Intermediate Licensing and M&A deals become more sophisticated and more rapid with every year that passes. Despite the sophisticated tools and metrics intended to maximize licensing and M&A value creation, is the process ultimately more art than science? How much of true success is the result of inspiration versus perspiration? And to what extent do all of these tools and metrics create noise and intellectual clutter that overcomplicates the deal process and hinders the transaction? Or is one person' s tool is another person' s weapon? Consider the " war stories" regarding the best deal ever put together by two CEOs late at night over a cocktail napkin. Is this fact or fiction? Our experienced panel of deal makers will explore this theme and share insights and conclusions based on their diverse transactional experiences. Marcus Brady, Partner, IBIS Biotech Benedict Monachino, Of Counsel, Lahive and Cockfield Kim Rosenfield, General Counsel, StereoTaxis Torben Skarsfeldt, Project Director, H. Lundbeck A/S 2-HEA-8: Route-Splitting, Not Indication- Splitting: A Superior Partnering Strategy to Maximize Your Molecule All Levels Molecules with certain important mechanisms of action may have many potential therapeutic uses, yet companies with limited resources often cannot explore a broad range of uses and hence miss opportunities to take multiple " shots on goal" . To solve this problem, companies naturally turn to partnering to obtain additional resources in exchange for sharing future upside. Historically, indication splitting (i.e. licensing the rights to a compound for use in alternative disease indications) has sometimes been used to explore multiple uses, but suffers from several pitfalls, such as requiring tight coordination of intellectual property prosecution and enforcement, pricing, manufacturing, and other dimensions of channel management and marketing to avoid substitution and brand confusion risks. Route-splitting, on the other hand, in which the licensed field of use is constrained to specific routes of administration and/or local interventions, may offer a superior strategy - providing the desired diversification of shots on goal without the undesired pitfalls of indication splitting. In this workshop, we examine how route-splitting partnerships can be used to maximize the potential of a molecule and recent examples of deals in which this has been done effectively. Pierre Belichard, Co-founder and Chief Operating Officer, Fovea Daniel Grau, Chief Operating Officer, CombinatoRx 2-HTS-5: Hot Topics in Licensing Digital Content in the Sports & Entertainment Industries Intermediate The explosion in the dissemination of digital content over the past decade has forced many industries to develop new and malleable licensing strategies to keep pace. The sports and entertainment industries are in many ways leading this digital content licensing revolution. As the technology used to disseminate digital content rapidly evolves, digital content licensing professionals must proactively develop and modify their licensing strategies. For example, as new media players arise, content providers must examine the impacts such media players have on the rights they grant and the restrictions they include to protect their disseminated content. Also, sports organizations have developed divergent strategies on licensing digital content. Some sports organizations have strategically chosen to aggressively out-license game footage through Internet websites to increase interest in their games. Conversely, the NFL has given very restrictive limitations on showing its game footage to promote NFL.com as the premier game footage source. These issues and other hot topics in licensing content in the sports and entertainment industry will be addressed in this session. Scott Bearby, Managing Director of Legal Affairs & Associate General Counsel, The National Collegiate Athletic Association Steven Smith, Member, McKee Voorhees & Sease PLC 2-HTS-6: The Intellectual Property Growth Cycle of Early-Stage Companies Intermediate Licensing of intellectual property (IP) allows early-stage companies to acquire proven technology and develop go-to-market plans quickly and, often, cheaply. However, the use of licensed IP to launch a business may impact the company' s exit strategies and options. In addition, many executives may not be fully aware of all the strategic uses of IP in support of the business. Investors in and acquirers of early-stage companies view IP as an important asset – many times the ONLY asset. Creative IP strategies, portfolio development, intellectual asset management practices, and effective communication can improve an early-stage company' s prospects of attracting investors or acquirers and enhancing the valuation of the firm. Case studies, presented by the principals involved, will highlight the lessons learned from several successful examples where early-stage companies licensed or acquired IP as the " seed" for its launch, developed a strategic IP portfolio, and exited becoming the " seed" for a much larger company. This workshop will share many lessons learned that companies can use to grow, leverage, and monetize their own IP portfolios. Jon Huard, Memory Link Douglas Roth, Senior Manager, ipCapital Group, Inc. Martin Suter, Cohda Wireless Limited 2-HTS-7: Best Practices in Licensing: Intellectual Property Policy Advanced The cornerstone of a world class licensing department is a well reasoned Intellectual Property Policy. The policy sets the context upon which the IP department functions, and defines its relationship to the overall corporate entity, and to the rest of the business community. The IP Policy is also an excellent foundation for the evaluation of the success of the IP department. This seminar will assist senior IP executives in the creation and critical evaluation of IP policies in the university, government, and industry sectors. The seminar will consist of lectures and case study analysis/discussion. Richard Baker, Director of Intellectual Property Licensing, 3Com Corporation Michael Femal, McDonald Hopkins, LLC 2-IUGI-3: Tools and Solutions for Successful Licensing Arrangements between Universities and Industry Intermediate The workshop explores solutions for addressing the many misunderstandings associated with licensing arrangements between universities and industry. Universities have different priorities than corporations associated with licensing technology. Universities may see the exploitation of the technology as the most important goal, with financial incentives as secondary. Corporations focus on the bottom line and how the scope of the license affects their ability to profit from the arrangement. These and other misaligned interests of the parties differentiate university/industry licensing from intercompany licensing. The workshop provides tools and solutions to address the unique challenges associated with negotiating and maintaining agreements between university and industry. Specific topics include resolving negotiation issues on the subjects of financial terms, rights granted, reserved rights, fields of use, sponsored research and performance diligence. The workshop examines the differences negotiating these issues from both a high-tech and biotech perspective, and offers a university and industry perspective for both areas. Solutions to overcoming impasses and providing for long-term successful relationships will be offered. Susan A. Capello, Sr. Intellectual Property Attorney, Intel Corporation Linda Chao, Senior Associate, Stanford University Patrick Gattari, Partner, McDonnell Boehnen Hulbert & Berghoff David Gulley, Associate Vice President, University of Illinois at Chicago 2-IUGI-4: Adding Value to Technology through Proactive OTT Business Development Intermediate The typical non-profit OTT takes the technologies (often in the form of ideas) disclosed to them, protects the intellectual property as best they can, and seeks a partner to commercialize the concept. Mayo Clinic has shifted that model. We work actively with inventors to develop their ideas into more mature, market-ready technologies. We do this primarily in two ways; refining the original idea to a more patentable state and constructing prototypes to generate preliminary data on the efficacy of the approach. The results have been impressive. Beginning only with an interesting idea, we have developed much broader, more robust, and well protected technology portfolios, sufficient to start several companies. This workshop will discuss our experience and methods, what works, what doesn' t and a couple of success stories. Tim Argo, Technology Licensing Manager II, Mayo Clinic Andy Danielson, Mayo Clinic 2-LGL-2: Corporate Tourniquets: The Need and Reasonableness of Obligation to Mitigate in IP Disputes All Levels In today' s corporate environment, severe damage can be done to the largest of business with great ease. Thumb drives, customer lists, patents and an assortment of other intellectual property can be stolen and inflict great economic damage. However, the economic compensation a business can recover from these acts is often limited by a failure to " mitigate" or by actions unreasonably considered " mitigation." This workshop explores the economic realities behind current mitigation and intellectual property law, and addresses what business executives and licensors can do to mitigate after sustaining a serious theft. It will address businesses' current mitigation obligations, at what point those obligations become too great, and at what point the methods of mitigation become unreasonable. These questions and more will be explored! David Cavallaro, Manager, Stout Risius Ross, Inc. Jeffrey Mordaunt, Managing Director, Stout Risius Ross, Inc. William Schaller, Partner, Baker & McKenzie LLP 2-LGL-3: Licensing after Quanta v. LG Intermediate Earlier this year the Supreme Court agreed to the hear the case of Quanta v. LG in order to address the issue of patent exhaustion and what rights are granted to a purchaser of a patented product from a patent owner or its licensee. This case has the potential to significantly impact what restrictions, if any, a patent owner can place on the use of a patented product. It also may impact whether a patentee can license multiple entities in the stream of commerce (for example, a codec designer, a chip maker, and a computer seller). Thus, in the spirit of e-Bay, Medimmune, and KSR, this Supreme Court could once again drastically alter the patent and licensing landscape. A decision is expected in this case sometime in early to mid 2008. This workshop will discuss the decision and its ramifications for licensing executives. It will also provide practical suggestions for achieving licensing goals in light of the decision. D. Brian Kacedon, Attorney, Finnegan Henderson Farabow Garrett & Dunner, LLP 2-BMD-2: Creative Deals – Model Agreements for University/Industry Collaboration in the Biomedical Device Field Intermediate This workshop will examine the structure and content of a model agreement for university and industry collaboration in the biomedical device field. While institutional research has formed the basis of many biomedical device innovations, the divergence in mandate between academia and private industry has prevented collaborations between the two from reaching their full potential. This session will consider the issues of innovation and commercialization in the biomedical device field from both an institutional and industry perspective, and in the process, present a model collaboration agreement which values the interests of both parties. The workshop will focus on creative ways to resolve the traditional areas of conflict. Teresa Colella, Technology Manager, Johns Hopkins University Jeff Franco, Principal, JD Franco & Company, LLC Jennifer MacInnis, Director, Intellectual Property & Contracts, University of Toronto 2-VAL-2: Something' s Wrong - Valuation, Licensing and Jury Awards in the Application Software Industry Intermediate/Advanced Since 2001,there have been a number of very large jury awards related to software and business method patents. These awards are not consistent with actual licensing transactions and the values of acquired intangbiles. This workshop will explore licensing terms and practices in the software industry. It will also cover a proprietary study of purchase price allocation trends and valuation methodologies used in the valuation of application software intangibles. Lastly, we will compare these ordinary course business activities with jury awards for software and business method patents. Philip Green, Principal, Hoffman Alvary & Co. 2-STR-2: Alliances and Partnerships as an Alternative to Licensing Novice In order to be competitive, more and more companies are moving towards alliance and/or partnerships rather than strict licensing arrangements. This workshop will focus on the differences between the various types of collaboration arrangements and the benefits of one type of business relationship over another. The workshop will include representatives of the financial and legal services arena, as well as corporate representatives to share their experience and lessons learned in structuring these business relationships. Jill Rusk, Associate Director, Navigant Consulting, Inc. 2-LOSM-1: Marketing Inventions: Leveraging Resouces in a Small Office Novice One of the toughest challenges facing most tech transfer professionals is the marketing of inventions, especially with limited resources and experience. Most tech transfer professionals have little or no marketing background or experience. Most tech transfer organizations deal with inventions at the earliest stage, where there is no identifiable product. The workshop will help the TTO to understand how to: 1) Identify opportunities for licensing 2) Describe the invention to attract licensees 3) Expand contacts to create licensing opportunities 4) How to use limited resources to accomplish all of the above. Experts will share their marketing tips, successes, failures, and best ideas. Michael Martin, President, TechTransfer Associates Imelda Oropeza, Marketing Specialist, Stanford University TUESDAY, OCTOBER 21, 2008 • 2:00 p.m. – 3:15 p.m. WORKSHOP SESSION 3 3-CEM-2: Licensing and Partnering Strategy for the Emerging Biofuels Industry Intermediate Climate change, energy security, and feeding the world' s poor are the most critical global societal problems we face today. The financial markets, politicians, and industry are responding to these problems with a number of proposed solutions. One with great technical and economic promise on a large scale is the development and commercialization of liquid transportation fuels form renewable sources. The emerging biofuels market is creating an unprecedented convergence of three industries: 1) agriculture, 2) energy, and 3) biotechnology. To competitively participate in the new industry will require thoughtful planning, analysis, and execution of a broad partnering strategy. Thought leaders from the lignocellulosic biofuels industry will provide an update on current state of the industry and possible scenarios for the future. For each scenario, the critical alliances and partnerships for success will be discussed. Strategic considerations driving the desired deal structure and transaction type will be analyzed for different components of the future biofuels value chain. Aaron Schuchart, Vice President, Corporate Development and Strategy, Mendel Biotechnology, Inc. 3-HEA-9: The Interface, or Lack Thereof, between Corporate Venture Capital and Corporate Business Development Intermediate This workshop will educate the audience on the difference structures employed at various pharmaceutical corporations, such as MedImmune/ AstraZeneca, Pfizer and Novartis, for the interactions between corporate venture capital and corporate business development. Eva Jack, Managing Director, MedImmune Ventures Debbie Yu, Pfizer Ventures 3-HEA-10: Acquisition Driven Business Growth Intermediate Increasingly, small companies are looking for exits through acquisition rather than IPO. Concurrently, perhaps more than ever before, larger companies are open to acquiring assets rather than licensing them. Hear from four pharmaceutical companies which have acquired companies as part of their growth strategy. Pamela Demain, Executive Director, Corporate Licensing, Merck & Co., Inc. Gaynor Fryers, Vice President, Strategic Planning & Business Development - Oncology & Infection, AstraZeneca Mark Nuttall, Executive Director, Licensing and New Business Development, Johnson & Johnson 3-HEA-11: BIG versus Small: What Can Be Learned from Switching Sides All Levels In a panel format, licensing professionals who have worked in both big and small healthcare companies talk about the changes in perspectives and lessons learned by switching sides. This would include discussions of what the licensing process looks like from the other side, what is valued in the process by each side, what is frustrating, what matters most., what they miss, and why they chose to make the switch. This could be lively, candid and useful. Jennifer Griffiths, Director, Search & Evaluation, Novartis Jit Patel, Director, Strategic Planning & Business Development, AstraZeneca Linda Pullan, President, Pullan Consulting Lesley Stolz, Vice President, Business Development & Corporate Development, Sunesis Pharmaceuticals 3-HEA-12: Choosing Where to Focus: How to Identify and Prioritize the Right Therapeutic Areas of Opportunity Intermediate Until recently, large pharmaceutical companies focused on developing primary care products with blockbuster potential. But leading companies are now moving in a new direction, placing their bets on specialty therapeutic areas that were once more commonly pursued by growth-oriented biotech or specialty pharmaceutical companies. This shift in strategy was driven by several factors, including the realization that primary care blockbusters are less common than in previous years, the proportionally greater number of specialty compounds (out of the overall number of compounds) available for licensing from smaller companies, and the need to fill pipeline gaps. Regardless of their rationale, the initial step in—and a significant hurdle to— pursuing this specialty model is selecting therapeutic areas or disease states on which to focus. Ben Bonifant, Vice President, Business Development Practice, Campbell Alliance Paul Biondi, Vice President, R&D Operations, Bristol-Myers Squibb 3-HTS-8: From Amazon to Watermarking: The Year' s Most Important Developments in DRM and Their Implications Intermediate Digtal Rights Mangaement (DRM) is a topic of great interest to LES members, but new developments in this area seem to be happening daily. New DRMs are introduced, leading edge content is introduced incorporating specific DRMs for the first time, previous DRM implementations are dropped, attempts are made to circumvent or compromise DRM schemes, court cases are filed and/or decided. It has been difficult to follow all the myriad developments and dynamics in this area. In this workshop, we will present our take on the 10 most significant developments related to DRM over the past year. Although much of the focus will be on court actions, other developments will also be covered. Don Drinkwater, Bose Corporation 3-HTS-9: Patent Quality and Subsequent Valuations Intermediate " What gets measured gets managed" says management pioneer Peter Drucker and if applied to Intellectual Property means that IP such as a patent must somehow be measured in order to increase the overall market value of an enterprise. This workshop takes a closer look at Dieter F. Reinhardt and Alexander J. Wurzer article in the December 2007 les Nouvelles on portfolio management and embraces the concept that quality plays a significant part in calculating IP value. In their article they discuss that value and quality should play a more significant part in patent portfolio analysis. This workshop will examine the assessment processes; quality evaluation and economic patent value appraisal. Dwight Olson, Founder, V3Data David Drews, CONSOR 3-IUGI-5: Development Collaboration and License / Option Agreements: A Case from Sustainable Energy Technology Development All Levels Co-sponsored with Chemicals, Energy and Materials. The roundtable will focus on the challenges faced in successfully negotiating a development collaboration agreement between two businesses or between a business and a research institution. A form agreement will be used to focus the discussion and will be distributed to the audience. There will be three parts to the roundable. First, the moderator will display key clauses from a sample development agreement and each panelist will comment on the challenges posed in a negotiation and constructive solutions. Second, small groups will discuss and comment, each joined by a panel member. Third, the panelists will complete the discussion with suggestions for achieving agreement in negotiating agreements. The field of sustainable energy and environmental technologies will be featured, and the unique challenges it presents will be highlighted, but the lessons drawn from the development contract should be generalized to all technology development contexts. Moderator: Cynthia Cannady, Attorney at Law, IPSEVA Speakers: Walter Copan, Executive Vice President and Chief Technology Officer, Clean Diesel Technologies Inc. Craig Smith, Technology Licensing Manager, Sandia National Laboratories 3-IUGI-6: Key Issues in Sublicensing Intermediate The expectation for university licensees used to be that the licensee would bring licensed products directly to market. Now more and more university licensees have a new(er) business model: sublicensing. Such licensees intend to develop the licensed technology up to a key development point and then sublicense to a larger company. This workshop will provide licensing executives will an opportunity to discuss adaptations of the legal and financial provisions of licensing agreements to the scenario where sublicensing will the key commercialization strategy of the licensee. The session will provide perspectives from university technology transfer, industry and legal. Moderator: Steven M. Ferguson, Deputy Director, Licensing & Entrepreneurship, Office of Technology Transfer, National Institutes of Health Speakers: Sarah Shoaf Cabot, Principal, Faber Daeufer & Rosenberg PC John Cosmopoulos, Senior Manager, Business Development, Tufts University Thomas Richardson, Manager, Business Development, Medarex, Inc 3-LGL-4: Antirust Aspects of Patent Licensing - Recent Developments All Levels The Department of Justice and the Federal Trade Commission released guidelines on licensing of patents and other intellectual property in 2007. These guidelines discuss how these two agencies will evaluate whether the terms in a patent license constitute an antitrust violation or not. The guidleines discuss which licensing terms would be subject to a more strict scrutiny versus others in terms of their antitrust implicaitons. The guidelines go into detail of strategic use of licensing, collaborative standard setting and other licesning arrangements. Krista Holt, Director, Ocean Tomo Dina Kallay, Counsel for Intellectual Property & International Antitrust, Federal Trade Commission Bill Latham, Department of Economics, University of Delaware Gauri Prakash-Canjels, Vice President, ARPC 3-LGL-5: The Nitty-Gritty of Working Strategies in Globalized Patent Litigation Advanced Operating in a global environment means that patent enforcement issues have to be dealt with on a multi-jursidictional basis. Each jurisdiction will have its own substantive and procedural rules for determing infringement and validity issues. The courts of the US, UK, and Australia, for example, differ markedly on some of the most fundamental matters including construction of patent claims, and the principles by which novelty and obviousness are tested. In the circumstances, developing a strategy for a commercially successful outcome in multi-jurisdictional patent litigation will require navigation of the many local substantive and procedural rules with an eye to their impact in other jurisdictions. How does one plan an effective strategy for securing the best outcome in the most cost-effective way? Are some jurisdictions speedier than others? Can experience / knowledge gained in one jurisdiction assist in others? What are the rules for engagement of experts? How will the local court determine the substantive legal issues? This session will analyse the issues which must be considered in developing a strategy for multi-jurisdictional patent litigation by providing a panel of three experts (US, Australia, UK ) who will speak knowledeably on the above issues. Ian Karet, Partner, Linklaters London Anthony Muratore, Partner, Gilbert + Tobin Rory Radding, Partner, Morrison Foerster BIOMEDICAL DEVICES SPECIAL SYMPOSIUM, PART 1 3-BMD-3: Commercialization and Growth by Acquisition in the Biomedical Device Industry, Part 1 This special symposium will examine merger and acquisition as a means to achieving commercialization of biomedical device technology. The topic will be presented from the perspective of (1) small device makers who have been acquired or have merged in an effort to bring their technology to market; (2) companies who have acquired other device makers as a strategy for growth; (3) device makers who are determined to " go it alone" ; and (4) VC' s who view acquisition as an optimal exit. The panel will draw on direct experience from recent transactions, and the presentations will be practical in nature with a focus on issues particular to the biomedical device industry. Ken Baker, Associate, Emergent Medical Ventures David Cassak, Managing Partner, Windhover Information Inc. Frank DiCosmo, President & Chief Executive Officer, Covalon Technologies Inc. Michael Greenberg, Chief Executive Officer, Fio Corporation Dave Meibos, Director of Intellectual Property, MedicineLodge Inc. Allan May, Managing Director, Emergent Medical Ventures 3-VAL-3: Patent Rating Systems:What are They, Really? Part 1 Intermediate The session, will be a roundtable discussion with three commercially practicing providers of patent ratings and one client user of patent rating systems. They will discuss rating systems in general and the differences between their systems. The selected providers have significant enough differences in their approaches to provide an interesting and educational discussion about the strengths and weaknesses of each approach. The participants would include at a minimum, discussion of claims, citations, linguistic, and human based systems. (Continued on Tuesday at 3:45 p.m. see 4-VAL-5) Andy Gibbs, Chairman and Chief Executive Officer, PatentCafe Michael Lasinski, Managing Director, Ocean Tomo Robert Lopes, Chief Technology Officer, ThinkFire Services USA, Ltd. Hoo-Min Toong, President & Chief Executive Officer, IPvision Inc. Matthew Troyer, Marketing Director, TAEUS International Corp. Stephen Weeks, First Principals Inc. 3-VAL-4: Royalty Monetization Advanced Companies, research institutions and inventors are increasingly, and wisely, monetizing existing and projected future royalty streams to provide cash and mitigate risk. In the brave new world of a knowledge economy, the value of intellectual property has risen dramatically, and financiers have developed a variety of new methods to capture and extract value from patents. Royalty monetization is one of these new methods, and it' s a sellers' market – high valuations, flexible deal structures, available capital, experts to help, and best practices to guide. Licensing executives, university technology managers, inventors, and professional service providers need to understand the benefits, risks, valuation methods, and deal structures of royalty monetization. These are high stakes transactions involving numerous parties with vast cultural differences. This interactive workshop will provide a how to guide to consider, plan, structure, coordinate and conclude successful monetizations. Moderator: Louis P. Berneman, Principal, Texelerate Speakers: Joseph Fondacaro, Executive Director, Cincinnati Children’s Hospital Medical Center John Gourary, Partner, Covington & Burling LLP John Leone, Paul Capital Healthcare Michael Weinmann, Executive Director, Morgan Stanley 3-LOSM-2: Going Beyond Search: Correlating Multiple Data Sources for Licensing Analysis All Levels Patent licensing analysis requires more than creative keyword strings across multiple databases as valuable opportunities can be lost in the noise using standard keyword search strategies. A wealth of information is available to Licensing Professionals, and capitalizing on it requires knowing where to find it and how to leverage it to your advantage. Targeted search goes beyond keyword strings by correlating patent information with other public data such as the market, financial and litigation history. These targeted searches allow you to quickly identify key intellectual property, find licensing prospects, and get a 360 degree view of the world from any company' s perspective. As a result, companies that leverage these public data sources in their search methodologies can easily double their licensing pipelines. This session will focus on new strategies for licensing analysis based on the wealth of public information on IP, market and litigation data so you can find hidden information to increase your overall licensing effectiveness. Doug Miller, Chief Marketing Officer, Innography Ryan Rozich, Consulting Engineer, Innography Tyron Stading, Innography TUESDAY, OCTOBER 21, 2008 • 3:45 p.m. – 5:00 p.m. WORKSHOP SESSION 4 4-CP-2: Organizational Models for Brand and Technology Licensing Intermediate/Advanced The licensing of brands and technology assets is vital to creating growth opportunities and generating profits that are additive to product sales and services. However, the objectives, processes, cycle time, and participants can vary quite significantly for closing deals for brands vs. technologies. The brand and technology licensing functions within a corporation can either be centralized or held separate. Each organizational model has its advantages and disadvantages, such as: Improved coordination of licensing efforts or greater likelihood of creating licensing packages that include both brands and technologies via a centralized approach, or Greater specialization of skills and focus in a brand-only or technology-only program. The industry experts on the panel will each detail their company' s organizational model for brand and technology licensing, what lead them to this model, and also share key learnings. The Question & Answer session will enable the further dissemination of know-how and will address issues brought up by attendees. Participants will gain a better understanding of different successful models for organizing licensing programs, hear from experts who work within these models, and have an opportunity to ask questions of the expert panel. Nat Milburn, Vice President, Global Marketing, Newell Rubbermaid Rachael Schwartz, IP Strategy Consultant, ipCapital Group, Inc. Kate Shore, Consulting Manager, ipCapital Group, Inc. Robin Sitver, Johnson & Johnson 4-HEA-13: M&A Amongst Smaller Companies Intermediate M&A amongst smaller and mid-size biopharmaceutical companies are increasing and providing another sustainable avenue for growth. Multiple M&A deals will be featured, with participation from an investor, acquirer and acquiree. M&A among small companies are used for a variety of purposes: to increase number of marketed products to offset R&D costs, to gain WW access for regional US or European company, and to sustain funding if unexpected bad clinical news develops. In addition, some new trends in M&A will be covered including selling earlier before making significant investments in product development. Jonathan Fleming, Managing General Partner, Oxford BioScience Partners Marie Schiller, Partner, Health Advances Michael Webb, Chief Executive Officer, Ascent Therapeutics 4-HEA-14: What Buyers Want: Understanding What Big Pharma In-Licensors Expect to See in Out-Licensing Documents Intermediate While the number varies depending on the size of a given therapeutic area, business development professionals at most of the top 10 pharmaceutical and biotech companies review hundreds of non-confidential documents each year to evaluate compounds' in-licensing potential. Out-licensors invest a significant amount of time and resources developing non-confidential documents to help elucidate their products' attributes in the hope of landing that much-needed deal, but what are the key characteristics of a product or company that lead licensing reviewers to move to confidential discussions? Ben Bonifant, Vice President, Business Development Practice, Campbell Alliance Adele Gulfo, Vice President, Business Development, Healthcare Innovation & Strategy, AstraZeneca Joanne Smith-Farrell, Senior Director, Worldwide Business Development & Licensing, Pfizer Carole Wilmot, Senior Director, U.S. Licensing, Sanofi Aventis 4-HEA-15: Getting a Deal Done with J&J: What You Need to Know Intermediate Dealing with Big Pharma can sometimes be overwhelming to small companies or those companies striking out with their first deal. Particularly, with a company like J&J with many divisions and management levels involved, the process can be daunting. In this workshop you will hear directly from a J&J Licensing Director who is responsible at the operating level for getting deals done. You will also hear from someone on the other side of the table who will share her insights on negotiating with J&J, things to avoid and how to keep the process on track. Workshop participants will share how you can indeed get a deal done successfully with J&J. This workshop will include: how to best be prepared with your approach; what are key trigger factors; what personnel you can expect will be involved; the timing of the deal process; and most importantly the success factors that will lead to deal closure. The workshop will also cover specifics on some recent deals that will help to understand J&J' s approach. The analytics involve with deals and negotiating points will also be explored. This workshop will be very interactive with participation from the audience. Mary Beth Cicero, President, MarketSense Ltd. Daniel Guido, Ortho McNeil Scott Lundeen, J&J Pharmaceutical Services 4-HEA-16: Negotiating the Floor: Connecting through " Push-Pull" in Partnership Negotiations All Levels Ever been stepped on while dancing? Or at the negotiation table? Then this is the workshop for you. This interactive ballroom dance workshop will explore the concept of push-pull during licensing and partnership negotiations through its parallelisms with partner dancing. Like in business negotiations, the key to leading and following on the dance floor is not about a one-sided endeavor of power vs. submission. Rather, it is about exercising the appropriate level of either resistance or rendition to ensure a graceful and spectacular outcome, where both parties are complemented and pleased. " Push-pull" negotiation will be explored through actual audience ballroom dance instruction and participation. No special equipment or sequins required. Fernando Salles, Sr. Director, Global Reserach Alliances, Organon, a part of Schering-Plough 4-HTS-10: Source Code Escrow: Optimal Value and Minimal Pain All Levels Source Code Escrow can be a critical enabler of deals that otherwise could not be done. But too often the initial discussion gets off track, lost in abstractions, and the objectives turn into a battle of wills with no meeting of the minds. This discussion will begin with framing the right objectives, informing and leveling expectations, structuring the important operational elements, and getting the right language in place. This workshop will focus on the practical and legal issues surrounding software source code escrow clauses and agreements. The analysis and conversation that precedes both parties thinking about the escrow will be the starting focus. The program will then explore effective drafting for escrow agreements, escrow licenses and escrow trigger provisions and how to avoid many of the pitfalls that occur when escrow events and conditions are triggered The legal part of the program will also provide insight into how courts deal with escrow provisions including bankruptcy court rulings (including how to deal with trustees) and state and federal courts. Jon Grossman, Partner, Dickstein Shapiro Don Jarrell, President, Digital Thinking, Inc. Dwight Olson, Founder, V3Data 4-HTS-11: Global Technology Licensing: Protecting IP Value in a Converging, Digital, Wireless World Intermediate As the convergence of voice, video, data and wireless continues, enabling providers to offer an ever wider array of products and services, opportunities for strategic alliances are increasing at a rapid pace. But as the related financial provisions of these alliances become more complex, it may be difficult to monitor partner compliance. In this session, two leading technology companies will describe the steps they take to insure the contracts they negotiate protect their royalty revenue and the processes and controls they have created to improve license compliance and cash flow. Donald Boles, Senior Vice President, Chief Patent Strategist, InterDigital Corporation David Marston, Advisory Partner & Leader, US Licensing and Contract Compliance Group, PricewaterhouseCoopers Eric Stein, Manager, Licensing Governance, NAVTEQ 4-IUGI-7: Successful Ventures with the Federal Technology Process All Levels Approximately 40 billion dollars is being spent annully by the U.S. Government to fund reasearch and development in this country. The research and development is taking pace at over 600 federeal laboratories and research centers in virtually all areas of technology. This workshop will provide an understanding of how to access and use technologies emanaitng from these laboratories. In addition, this session will provide experts from important government labs such as the Department of Defense Labs and NIH to explain how your company can access these laboratories. Further, the workshop will provide leaders from companies who have been successful in utilizing the federal laboratory stucture to enhance their business development. These leaders will explain the benefits and pitfalls of dealing with the government. Rochelle Blauwsteen, National Institute of Health Jacob Erlich, Partner/Patent Attorney, Burns & Levinson LLP Paul Mela, US Army Medical Research and Materials Command 4-IUGI-8: IP Ownership in Industry Collaborations Intermediate/Advanced The typical IP ownership language in industry sponsored research agreements between US research institutions and companies state that inventorship governs ownership. Institutions will typically negotiate this type of language regardless of the probability that any IP will result from the project. Industry typically argues that this complicates negotiations needlessly because it doesn' t take into account the realities that any given project will lead to IP and a company' s need to completely avoid any risk that any aspect of its valuable IP may be owned by a third party following a sponsored research project. There has also been anecdotal reporting that US companies have moved some sponsored research offshore to countries where the sponsor owns the IP that results from the sponsored project. The workshop would examine the question of whether this model needs any re-thinking and whether there are scenarios in which a US research institution could be more flexible with its IP language in industry sponsored research agreements. The workshop will also provide an opportunity to the audience to participate and discuss examples and issues. John Cosmopoulos, Senior Manager, Business Development, Tufts University 4-INTL-1: What Type of Clauses Should You Be Careful of in a Licensing Agreement: Review of the Law and Practice Intermediate On many occasions, Latin American attorneys are asked by U.S. and European clients to review license agreements in order to know if they conform to local law and practice, even if such contract will be governed by US or European laws. When conducting this work local counsel finds that clauses contained in them may be grouped in different categories, some of which are the following: clauses that are superfluous and that may be kept in the agreement since they do not cause any harm; clauses that are unnecessary and here also, they do not need to be removed; clauses that are null and clauses that are unforceable. During the workshop, speakers from various Latin American countries will make a review of such clauses explaining why they fall in some of the listed categories, with practical examples. Speakers from the US and eventually from a European country will give their views and recommendations when dealing with agreements which involve some or all the Latin American markets and which include some of the clauses that are considered null or unforceable in those countries. Gustavo Giay, Partner, Marval, O' Farrell & Mairal Fernando Noetinger, Senior Partner, Noetinger & Armando 4-LGL-6: Biotechnology Licensing Issues In View of MedImmune, Quanta Computer, and Merck KGaA Intermediate This workshop will include an overview of these challenges and opportunities presented by these doctrines, actual case studies and examples that involved the two workshop presenters, and how licensing professionals in biotechnology can anticipate and maximize value. (1) MedImmune topics will include how to draft clauses to capitalize or minimize on the dramatic shift in the balance of power towards the patent licensee, and how entering into a license can be considered a nimble pre-litigation tactic, and address unique situations involving biotechnology end-products and laboratory tools. (2) Quanta Computer topics include how patent exhaustion restricts the licensor' s ability to limit patent usage post-first sale. Topics will include using " notice" to trigger the remaining permissible limitations on patent goods, as well as strategies for system, apparatus or process patents. (3) Merck KGaA topics will include providing insight how to decrease the likelihood that biotechnology " research tools" will fall into the " safe harbor" after Merck KGaA v. Integra Lifesciences I, Ltd. This workshop will provide novel approaches to protecting " research tools," e.g., that the tool is authorized only for " commercial activity," as well as other techniques to protect such tools from the " safe harbor" exemption. J. Dana Hubbard, Chief Patent Counsel, Millipore Corporation Bradley Olson, Counsel/Attorney, Dickstein Shapiro LLP 4-LGL-7: Managing the Gladiators - Surviving Patent Litigation Intermediate/Advanced Managing the Gladiators - Surviving Patent Litigation Patent litigation is both an increasingly necessary evil and one of the most stressful event that a company or tech transfer office can endure. This workshop will comprise an experienced patent litigator, a representative of a university tech transfer office that has managed patent litigation and a patent prosecutor/opinion expert who has seen a patent through litigation. They will discuss how to prepare for litigation, and present tips for surviving (and winning) it. Robert MacWright, Executive Director, University of Virginia Patent Foundation Ronald Schutz, Partner/Attorney, Robins Kaplan Miller & Ciresis Robert Sloss, Farella Braun + Martell Warren Woessner, Shareholder, Schwegman Lundberg & Woessner. PA BIOMEDICAL DEVICES SPECIAL SYMPOSIUM, PART 2 4-BMD-4: Commercialization and Growth by Acquisition in the Biomedical Device Industry, Part 2 Intermediate This special symposium will examine merger and acquisition as a means to achieving commercialization of biomedical device technology. The topic will be presented from the perspective of (1) small device makers who have been acquired or have merged in an effort to bring their technology to market; (2) companies who have acquired other device makers as a strategy for growth; (3) device makers who are determined to " go it alone" ; and (4) VC' s who view acquisition as an optimal exit. The panel will draw on direct experience from recent transactions, and the presentations will be practical in nature with a focus on issues particular to the biomedical device industry. Ken Baker, Associate, Emergent Medical Ventures David Cassak, Managing Partner, Windhover Information Inc. Frank DiCosmo, President & Chief Executive Officer, Covalon Technologies Inc. Michael Greenberg, Chief Executive Officer, Fio Corporation Dave Meibos, Director of Intellectual Property, MedicineLodge Inc. Allan May, Managing Director, Emergent Medical Ventures 4-VAL-5: Patent Rating Systems: What are They, Really? Part 2 The session, will be a roundtable discussion with three commercially practicing providers of patent ratings and one client user of patent rating systems. They will discuss rating systems in general and the differences between their systems. The selected providers have significant enough differences in their approaches to provide an interesting and educational discussion about the strengths and weaknesses of each approach. The participants would include at a minimum, discussion of claims, citations, linguistic, and human based systems. Andy Gibbs, Chairman and Chief Executive Officer, PatentCafe Michael Lasinski, Managing Director, Ocean Tomo Robert Lopes, Chief Technology Officer, ThinkFire Services USA, Ltd. Hoo-Min Toong, President & Chief Executive Officer, IPvision Inc. Matthew Troyer, Marketing Director, TAEUS International Corp. Stephen Weeks, First Principals Inc. 4-CLP-1: Certified Licensing Professional and You: Q&A Workshop The Certified Licensing Professional (CLP) program, an initiative of LES USA Canada, Inc., is the right program at the right time for individuals pursuing a career in licensing. The workshop will discuss the value to your career and professional development of becoming a CLPTM, as evidenced by the advantages provided by certification programs in other professional fields. To become a CLP, a candidate needs to have a bachelor' s degree, 3 years of professional licensing experience (and work in the licensing field at the time of application), and pass the CLP examination. The workshop will also address what' s covered in the CLP exam, including review of a few sample test questions. NOTE: CONSIDER TAKING THE 3-HOUR CLP EXAMINATION AT TEST LOCATIONS IN ORLANDO BEFORE OR AFTER THE LES MEETING. FOR MORE INFORMATION, VISIT www.LICENSINGCERTIFICATION.org. DON'T WAIT—AVAILABILITY IS LIMITED. 4-OTH-1: Licensing Patents after " Patent Reform" Advanced Recently, there has been a palpable change in how patents are being treated by our government. Some argue that all branches of the government have taken steps to actively limit patent rights: Congress is considering sweeping patent reform making it easier to challenge the validity of a patent and more difficult to obtain damages; The USPTO' s proposed rules packages make broad patent protection more difficult and costly to obtain; The Supreme Court recently has decided an unprecedented number of patent cases and, in each case, reeled back patent rights; the Federal Circuit has followed the Supreme Court' s lead. The speed at which the pendulum has swung away from governmental support of strong patent rights has been alarming to many patent proprietors. We will discuss the impact these changes are having or are expected to have on future licensing transactions. Is the value of patents being intentionally limited by the government, or is the government merely addressing true excesses? How will the relative ease at challenging the validity of patents and difficulty in obtaining damages and/or injunctions impact future licenses? What impact will the administrative difficulties of the USPTO have on future licensing considerations? Will these trends continue? Moderator: Michael Dunnam, Partner, Woodcock Washburn LLP Bruce Bernstein, Coller Capital John Whealan, Senate Judiciary Committee WEDNESDAY, OCTOBER 22, 2008 • 2:00 p.m. – 3:15 p.m. WORKSHOP SESSION 5 5-CEM-3: Trade Secret Best Practices Intermediate A considerable portion of a business' value can often be attributed to its intellectual assets, i.e. patents trademarks copyrights and trade secrets. While the patent, trademark and copyright elements of intellectual assets are generally clearly identified and well managed; trade secrets, despite being a significant business asset that provide a competitive business advantage, are often not effectively identified, adequately safeguarded nor fully exploited. This intermediate session will discuss potential business, university and government lab protocols, tactics and best practices to address safeguarding of trade secrets; including protecting trade secrets through contracts with consultants, current and former employees, suppliers and customers. In addition, suggestions for policing trade secret agreements will be discussed. Mitch Charness, Lawyer, Ridout & Maybee David Tyrrell, Vertex Intellectual Property Strategies Inc. Anthony Venturino, Patent Attorney, Novac Druce & Quigg 5-CP-3: Top Ten Black Holes in Brand Licensing The description will be posted as soon as it is available. Barry Brager, Managing Partner, Perception Partners 5-HEA-2: Deal or No Deal?: How to Take the Right Risks to Get the Greatest Rewards in Biotech Dealmaking Intermediate Imagine this scene: you are an biotech executive responsible for maximizing corporate value while driving company growth. In front of you are several desirable partners, each holding a briefcase that represents a different deal with a distinct level of risk—from an early-stage license to a POC-stage risk-sharing deal to an acquisition. The final briefcase represents a decision to forego any deal and drive the product to market alone. So, deal or no deal? Deals are a great source of non-dilutive cash and should provide validation and fuel growth. The right deal leverages a company' s past successes and propels it to the next level, but doesn' t require it to grow too much too soon. This session will discuss how to identify and secure the right deal at the right time and maximize reward without exceeding one' s grasp. Targacept, AZ and GSK representatives will discuss how to identify, structure and secure the right deal at the right time. Case studies of the Targacept/AZ POC-stage deal in Alzheimer' s/schizophrenia and the Targacept/GSK risk-reward sharing deal in pain, smoking cessation, obesity and Parkinson' s will be presented. Jeffrey Brennan, Vice President Business & Commercial Development, Targacept John Cantello, Director, Business Development - Drug Discovery, GlaxoSmithKline CEEDD John Reid, Director, Global Alliance Management - CNS/Pain, AstraZeneca 5-HEA-17: Building Franchises through Licensing and M&A Intermediate/Advanced Building a franchise requires more than a single product. While a Lipitor or a Rituxin may be a franchise all to itself, most companies have a more modest set of assets that might provide an interesting foundation but limited long term growth potential. Internal pipeline development may be too thin or immature to drive towards the multi-billion dollar potential necessary to be a sector leader. Dynamic franchise growth demands an aggressive in-licensing and M&A plan. This session will bring together strategic, M&A and licensing professionals to discuss how to develop a transaction-driven path to assembling a sector leading presence. Matching franchise objectives with the realities of asset availability and price/value considerations can lead to a clearer vision of the opportunities and priorities, a more robust context for valuation of deals and streamlined implementation following the deal. We will discuss how specific franchise strengths are used to guide the search for intriguing assets and, conversely, how a transaction can invigorate a franchise. Finally, we will explore how the ability to leverage franchise-driven R&D and commercial capabilities can influence the valuation of a particular asset. Michael Broxson, Director, Global Licensing and Business Development, Takeda Pharmaceuticals North America, Inc. Mason Irving, Partner and Managing Director, Health Advances LLC 5-HEA-18: Licensing Assets to Repurpose in New Indications Intermediate As companies struggle to find new " blockbusters" , a burgeoning interest has developed in repurposing assets in a new indication when they have failed in their initial indication. Several companies have built entire business models on licensing these failed assets from their original company. Learn how to find value from your " failed" assets from experts in the field. Alex Chausovsky, Vice President, Business Development, Optimata Ltd. R. Douglas Hulse, Executive Director, The Sage Group William Peters, Chairman & Chief Executive Officer, Adherex Inc 5-HEA-19: Business Development under Pressure – Getting it Done, Right, Fast! Intermediate/Advanced While your BD&L team has been " re-engineered" to half its size, you still need to in-license 3 new winners by year' s end. Your most recent deal is facing serious problems as both parties are already out of alignment and your BD&L counterpart is not returning your calls. The Board is breathing down your neck and your admin assistant just quit. What do you do? You attend this session! The panel will present their own changing reality where BD&L teams are faced with increased pressure to perform in a context of heightened competition, soaring deal prices, personnel attrition and stakeholder pressures are all affecting BD&L team performance. This session is about best practices and real life applications of project management principles to BD&L activities, relationship management and execution. Benoît Hébert, President, BioConsult Hébert Rousseau, Inc. Susan Koppy, Vice President, Corporate Development, Transcept Pharmaceuticals, Inc. Mark Nawacki, Vice President, Business and Corporate Development, Paladin Labs, Inc. Ed Schutter, President and COO, Sciele Pharma, Inc. 5-HTS-12: You Want to License? To THEM??? Intermediate Licensing Trends in Transportation & Aerospace (T/A) Industries: The Transportation & Aerospace Committee of the High Tech Sector is committed to providing education on peculiarities of Licensing within these industries. A prior workshop examined the complexities of Licensing in the ITAR environment; this workshop continues the theme, featuring Licensing of non-core technologies and outside the T/A sphere. In T/A, companies have historically confined their out-licensing to their core technologies; generally only licensing within the industry. Some are reluctant to license at all. Whether due to habit, lack of knowledge of opportunities in other industries or simply corporate reluctance to " color outside the lines" , out-licensing non-core technologies and licensing beyond the T/A community has been rare. These self-imposed restrictions have somewhat loosened in recent years, and a number of successful deals across industry lines have been consummated. This workshop will present some of the success stories, examine the historical reluctance to do deals and highlight some of the lessons learned through these recent deals. The panel will look at deals emanating from both large and small companies and from a cross-section ranging from highly conservative corporations to smaller, more nimble and entrepreneurial organizations. Robert Held, Director, Intellectual Property & Strategic Technology Agreements, Northrop Grumman Corporation George Park, IPVALUE Management, Inc. Joel Parker, Manager, Licensing, Pratt & Whitney James Runstadler, Textron Innovations, Inc. 5-HTS-13: Dissolving the Myths of Licensing Outside the U.S. and Europe Intermediate Articulate experts behind the global licensing programs of the Chinese-based telecommunications firm, UTStarcom, will discuss current realities – and myths – underlying licensing relationships in emerging economies. The panelists will discuss national and local governmental policies, cultural requirements and local business laws relevant to ongoing contractual arrangements with firms outside the US and Europe. The panelists will describe, in particular, the current state of the evolving contractual environment in the PRC and India and give examples of their experiences to underscore key points. Questions will be welcomed. Russell Boltwood, Vice President, Licensing & Intellectual Property, UTStarcom, Inc. Bradley Hulbert, Founding Partner, McDonnell Boehnen Hulbert & Berghoff LLP Gong Jun, Vice President, Licensing & Intellectual Property, Jun He Law Offices 5-IUGI-9: Large Company-Small Company Collaborations: Overcoming Commitment Issues All Levels Traditional licensing arrangements have evolved into joint collaborative efforts, but both sides face relationship issues. Large companies are seeking new technologies but don' t always get a warm reception from start-ups and researchers who fear losing control of their technology. How to facilitate those conversations and safely share enough information to decide if both sides want to take the next step will be discussed. A representative from a large corporation will provide their viewpoint, and lawyers for start-ups and researchers will share their concerns and needs. At this session, we will present solutions and strategies faced by both sides of the potential collaboration: how to find potential partners and how both sides can have comfortable but in-depth preliminary conversations to see if they are ready to move to the next level. Special attention will be given to in-house commercialization personnel seeking to find and learn about start-up and university-level technologies, and to university technology transfer professionals who want to get the message out but are rebuffed by overly timid inventors. Ways in which researchers and inventors can share information will also be discussed. Mary Ann Capria, Corporate Counsel, DuPont Legal Pradeep Haldar, Head, NanoEngineering Constellation, Professor, College of Nanoscale Science and Engineering, Director, E2TAC Richard Honen, Partner, Phillips Lytle LLP Kelly Mooney Lester, Partner, Phillips Lytle LLP 5-IUGI-10: Non-U.S. Patent Protection: Factors in Decision Making Intermediate When patenting decisions are " on your nickel," how do you decide, as an academic or federal lab technology transfer professional, where to spend your scarce financial resources? The purpose of this audience-interactive workshop is to explore the decision making process that precedes the quest (or foregoing) for non-U.S. patent protection. The practicing technology transfer professional is faced with making such decisions on a daily basis and often very early in the process of patent protection. How do practitioners in differing settings, including universities, government labs and industry go about making such decisions? What are some of the current global issues and trends that impact such decisions? The questions will be explored from various angles such as cost, markets, jurisdictions and enforceability. The impact of such decisions, often made early in the lifecycle of a technology, on future licensees and licensing returns will be explored. The workshop will be led by a trio whose extensive experience base covers government lab, university and a patent attorney. Ashok Choudhury, Senior Technology Commercialization Associate, Vanderbilt University Gregory Nelson, Shareholder, Akerman Senterfitt Christopher McKinney, Director, Office of Technology Transfer and Enterprise Development, Vanderbilt University 5-INTL-2: Rules and Pitfalls of Access to Natural Genetic Resources in Latin America Intermediate Sponsorsed by the LESI AMERICAS COMMITTEE Access to biodiversity and to associated traditional knowledge is being discussed in many forums, such as WTO and WIPO, since a relevant number of countries understand that they should create rules in order to guarantee a fair share of the benefits derived from the exploitation of genetic/biologic material accessed in their - and sometimes foreign – territories. Access is controlled by many forms, but in general the prior grant of some sort of governmental authorization and the indication of origin in patent applications are required. These rules have a profound impact in intellectual property and licensing, especially in areas such as cosmetics, pharmaceuticals, biotechnology, agricultural and foods. Many observers understand that these rules end up creating additional patentability criteria, not provided for in TRIPS. Companies and academia alike complain that, in some cases, research of biodiversity is curbed in view of the bureaucracy, uncertainty and delay involved in the process. The strength of future patents could be at stake due to several reasons, such as uncertainty of what activities need official authorization and the sheer impossibility of determining the very first origin of a given component of the biodiversity or of associated traditional knowledge. Héctor Chagoya, Technical Analysis & Technology Marketing, Manager, Becerril, Coca & Becerril, S.C. Gustavo de Freitas Morais, Dannemann, Siemsen, Bigler & Ipanema Moreira Juan Pablo Egaña, Partner, Sargent & Krahn Raul Hey, Partner, Dannemann, Siemsen, Bigler & Ipanema Moreira 5-INTL-3: Public Health and Compulsory Licensing Issues: Global Issues Intermediate Member countries of the WTO agreed in 2003 to allow certain flexibilities for countries to issue compulsory licenses for patents, in order to provide for export of products, to allow access to pharmaceuticals in countries which do not have manufacturing facilities. Canada adopted legislation in 2005; the E.U. in 2006, and the U.S. has considered draft legislation implementing compulsory licensing. However, some other countries have proceeded to use compulsory licences within their own countries, for public health purposes, leading to some uncertainty as to the strength of IP rights particularly in developing and least developed countries. Legislation under the 2003 WTO Doha Decision is but one sign of the changing tide as governments attempt to address budgetary and access issues relating to pharmaceuticals for public health purposes. In Canada, for example, consultations are underway to address access to unmarketed drugs in situations of public health emergencies or biodefence situations. The session will inform participants as to the developments in the law relating to compulsory licensing and public health initiatives in various countries. Adrienne Blanchard, Partner, Gowling Lafleur Henderson LLP Ian Dodds-Smith, Arnold and Porter LLP Eric Noehrenberg, International Federation of Pharmaceutical Manufacturers Jon Santamauro, Counsel, Sidley Austin 5-LGL-8: Effective Selection, Preparation, and Use of Expert Witnesses in High Technology Patent Litigation Advanced Whether you are facing sophisticated technology or complex damage calculations, sometimes an expert is just what the doctor ordered. So, do you call a " Doctor" or will a hands-on industry veteran do a better job? What recent case law might affect how you define your expert screening criteria and exactly what are the rules when it comes to using experts? This workshop answers these questions and more. Technical and accounting consultants and F.R.E. 702 experts will be defined along with practical steps for finding, selecting, hiring, and working effectively with a winning expert. From search tips and interview strategies all the way to preparing your expert for trial, the panel will update you on the latest thinking and approaches to getting the most from consultants and testifying experts. Scott Bechtel, President, AmiCOUR International LLC Hon. Joseph J. Farnan, Jr., US District Court, District of Deleware Ray Throckmorton, AmiCOUR International LLC Michael Warnecke, Partner, Perkins Coie LLP 5-LGL-9: The Legal Framework for Federal Patent Licensing Advanced The presentation s structured as an overview of the legal framework that governs federal patent licensing. It addresses the public policy rationale, steps through the applicable statutory and regulatory structures, highlights the contrast between CRADA (Cooperative Research And Development Agreements) and non-CRADA licenses, and offers recommendations for implementation of the workshop lessons in the workplace. Mark Thomas, Managing Attorney, Reid Law Group LLC 5-BMD-5: A Global Approach to Licensing Strategy and Valuation for Devices All Levels As the medical device industry has become increasingly global, product licensing and product development decisions need to reflect a global perspective. However, leading companies have been challenged to adapt to this new reality. One of the most important gaps has been the ability to effectively identify and evaluate market opportunities on a global basis. Outside of their core US and western European markets, most companies don' t have the infrastructure to identify unmet need or develop realistic forecasts. Market research and analysis tend to be pursued on a local or regional basis based on inconsistent and often flawed methodologies, so the global roll-ups are suspect. At the same time, the increasing influence of government and private payers around the world on market adoption and pricing of new products have challenged companies to understand, address, and shape their approaches to establishing clinical and health economic value. This workshop will bring together global marketing and business development leaders from major medical device companies who have led the transition to more effective approaches to global market analysis. The panel members will discuss the challenges they encountered and the approaches they adopted to establish a robust analytical foundation for licensing and business development. Timothy Bedard, Director, Intellectual Property Strategy, Ethicon Endo- Surgery, a J&J Company Jack Nightingale, Consultant, Numerof & Associates, Inc. 5-CLP-2: Certified Licensing Professional and You: Q&A Workshop The Certified Licensing Professional program, an initiative of