Day One: Monday February 27, 2012
7:45 Registration and Continental Breakfast
8:45 Co-Chairs’ Opening Remarks
William F. MonganExecutive Director, US Business Development
AstraZeneca Pharmaceuticals (Wilmington, DE)
John A. HurvitzPartner,
Covington & Burling LLP (Washington, DC)
IP Strategies and Considerations
9:00 What the America Invents Act Means for Deal Makers and Business Development Strategies
Peter Cicala
Vice President of Intellectual Property,
Shire (Wayne, PA)
Matthew J. Golden
Legal Director,
Patents,
Merck & Co., Inc. (Kenilworth, NJ)
Jennifer A. Camacho
Shareholder,
Greenberg Traurig LLP (Boston, MA)
This session will provide essential insights into how the recently enacted Patent Reform legislation will impact pharmaceutical and biotech pipelines and reshape future business analyses.
Points of discussion will include:
- Dissecting which provisions were included in the fi nal passage of the America Invents Act (and what was left out)
- Assessing how the Act will impact on the level of new patenting activity going forward
- Drilling down into what has been changed and the potential impact on licensing and the performance of due diligence
- treatment of joint research agreements under the Act
- departure from first to invent system
- personal grace period
- broadened scope of patent-defeating prior art
- broad prior user rights provisions
- diminished role of the inventor in patent filing
- treatment of academic institutions and inventions generated by or with them
- Understanding the practical takeaways impacting on strategies for business development
- incorporating a transactional perspective into updated approaches to patenting
- M&A considerations
- Impact of the Act on value and viability of trade secrets
10:00 Morning Coffee Break
10:15 Identifying IP Red Flags that Impact the Value and Success of a Life Sciences Transaction
Shane R. Albright
Partner,
Hogan Lovells US LLP (Palo Alto, CA)
Seth Jacobs
Senior Patent Counsel,
Pfizer, Inc. (New York, NY)
Experienced members of IP due diligence teams see certain issues arise time and again which significantly derail a potential partnership or acquisition. In this session, panel members will share their “top ten lists” of challenges unearthed in the course a deal that have led to significant consequences. Points of discussion include:
- Overstatement of IP rights held by the target or partner company
- Previous out-licensing activity
- Pending litigation risks
- Use restrictions that would impact on the business reasons for the partnership
- Rights retained by inventors
- Restrictions contained in settlement agreements
- Failure to protect trade secrets
11:15 Deciphering Alterna ve Business Models to Select the Best Deal Structure in a Time of Changing Industry Dynamics
Erika Geimonem
Licensing and Business Development
Luitpold Pharmaceuticals (Norristown, PA)
Jim Neal
Vice President, Business Development,
XOMA (Berkeley, CA)
Laura Ripin
Director, Business Development & Licensing,
Novartis (Cambridge, MA)
Daniel Ilan
Counsel,
Cleary Gottlieb Steen & Hamilton LLP (New York, NY)
Moderator: John Hurvitz
Partner,
Covington & Burling LLP (Washington, DC)
- Analyzing current market information and deal drivers
- the patent cliff is NOW
- are patents the “new currency”? relating the growing strategic role of patents in other industries to life sciences
- examining the externalization of R&D
- complexities in pipeline valuations that can derail deals
- dissecting recent upfront and milestone payments
- royalties negotiated for different therapeutic categories
- impact of IP protections overseas on deal-making
- Understanding how the pendulum swings between partnering and M&A
- have the year’s mergers and acquisitions impacted negotiating agreements?
- financing landscape and relative bargaining strengths
- how much cash is still available?
- are assets overvalued?
- Assessing recent trends in deal structuring
- how companies have been acting to better hedge their development risks
- risk sharing being incorporated in transactions
- option-based licensing
- use of CVRs (contingent value rights)
- how deal strategies are being adjusted to account for:
- great focus on niche “non-blockbuster” products
- recent activity by generic manufacturers
- heightened interest in OTC, nutritional, drug delivery and veterinary products
- Comparing asset purchases vs. stock purchases vs. joint ventures
- understanding the different IP ownership and licensing traps
- considering whether to make equity purchases part of the agreement
- possible models for equity investment
- complexities in negotiating timings and share prices of equity purchases
- Determining what structure may yield the greatest potential return on investments
- weighing whether to negotiate provisions for:
- straight licensing
- co-promotion
- co-commercialization
- co-development
- cross-licensing
- investment, profit-sharing and co-funding
- out-licensing
12:30 Networking Luncheon for Speakers and Delegates
Buyer and Seller Strategies
1:45 Preparing Your IP for M&A or Product License: What Savvy Buyers Look For
Robert Hrubiec
Vice President, Intellectual Property,
Cephalon (West Chester, PA)
Kim Parker
Vice President, Corporate Counsel and Legal Site Head
Novartis Vaccines and Diagnostics (Cambridge, MA)
Fahd M.T. Riaz
Partner,
Morgan Lewis (Philadelphia, PA)
Timothy H. Ehrlich
Partner,
Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP
(Waltham, MA)
- Performing a proactive audit in advance of various types of negotiations
- assessing the strength of your patents
- uncovering where you may have patented too broadly or too narrowly
- Looking at the current market and what types of deals are on the horizon
- why dealmakers are expecting the climate to be active in 2012
- valuation trends and the prices being paid
- Identifying different terms in your previous transactions that may serve to facilitate or hinder future M&A and licensing
- rights to co-developed intellectual property
- termination provisions
- right of first refusal
- right of first offer
- right to participate in future financing activity
- change of control provisions
- potential exposure in government inquiries
- Tips for effectively positioning your assets
- how to account for different clinical results
- addressing potential regulatory hurdles or triggers
- techniques for generating interest without overstatements
- identifying potential synergies for respective parties
2:30 Afternoon Refreshment Break
2:45 Partner Selection for Facilitating Product Development and Maximizing Commercial Returns
Pavan Handa
Senior Vice President, Business Development,
Antares Pharma, Inc.
Gilbert R. Mintz, Ph.D.
Managing Director,
Fast Forward, LLC (San Francisco, CA)
Patricia Vaughan
General Counsel, The Population Council (New York, NY)
Moderator: Tom Duley
Of Counsel,
DLA Piper (San Francisco, CA)
- Weighing the benefits and potential synergies that you will seek in a business partner
- considering what they might bring to the alliance
- determining what you want to leverage and take out of the agreement
- Sourcing for a good fit
- knowing what practical information will help with your analysis
- evaluating when your business models can be fully incorporated into dealings with another company
- considering what may present obstacles to growth
- concerns relating to freedom to operate
- Identifying foundations and therapeutic areas with compatible goals
- Determining whether you can strategically align with a non-profit
- how the unique focus of a philanthropic foundation may impact on any agreement
- Performing effective business due diligence
- taking into account business concerns that may necessitate increased scrutiny
- financial stability
- confidentiality concerns
- compliance records
- supply arrangements
- Avoiding common partnering selection pitfalls
- dissecting whether the alliance can really be mutually beneficial
- determining whether it will be difficult to monitor/audit performance
- anticipating potential difficulties in effectively setting forth and documenting who owns what and what entities are involved
4:15 Opening Doors to New Markets and Products with Strategic Alliances
Brian Adams
Corporate Counsel,
AVEO Pharmaceuticals (Cambridge, MA)
Tong Zhang
Pan Regional Lead, Emerging Markets Business Development
Merck (Whitehouse Station, NJ)
James Zhu
Partner,
Jun He Law Offices (Palo Alto, CA)
- Evaluating which emerging countries to look to for international deals:
- pros and cons of current hot spots for partnerships outside of the U.S.
- uncovering their unique legal, regulatory and cultural challenges
- developing strategies for gaining access to:
- new patient populations
- low-cost manufacturing
- research and development
- Assessing the potential for negotiating a successful joint venture for commercializing non-prescription or generic products
- evaluating whether the companies can work together effectively
- devising a strategy for leveraging your partner’s local strengths
- determining how local distribution channels will be shared
- anticipating what obstacles will have to be faced and the potential deal-breakers
- determining risks to IP and trade secrets
- Setting terms for profitable co-promotions
- negotiating provisions for sharing local sales
- Avoiding common pitfalls associated with international agreements
- steering clear of contract terms that violate the legal requirements of foreign jurisdictions and may risk invalidation
- Employing a practical IP strategy within the agreement
- ensuring that foreign patent laws are considered before marketing your products in new markets
- Protecting your trade secrets
5:15 Conference Adjourns to Day 2
Day 2: Tuesday February 28, 2012
7:30 Continental Breakfast
8:30 Chairs’ Welcome and Summary of Day 1
8:45 Bayh-Dole after Stanford: Revising Research Agreements with Academic Institutions
Rachel Cassidy
Associate Director, Licensing,
Johns Hopkins University (Baltimore, MD)
Robin Rasor
President, AUTM, Director of Licensing
University of Michigan (Ann Arbor, MI)
John Ritter
Senior V.P. Corporate Development and Strategy
Princeton University (Princeton, NJ)
Christopher Verni
Senior Patent Counsel,
ARIAD Pharmaceuticals (Cambridge, MA)
Moderator: Eldora L. Ellison
Director,
Sterne Kessler Goldstein Fox (Washington, DC)
- Understanding the current Bayh-Dole landscape for tech transfer agreements
- impact of the Supreme Court’s decision in −Stanford v. Roche
- why the court sided with Roche while the Obama Administration took Stanford’s side
- analyzing Judge Breyer’s dissent
- practical consequences for interpreting assignments
- Pinpointing recent points of contention between industry and academia in collaborative research
- Identifying and overcoming the most common frustrations in negotiating agreements with universities
- knowing who has authority to negotiate
- successful tactics for negotiating unique terms
- Current synergies, cultural differences and common objectives between industry and academia
- differences between different universities
- public vs. private universities and state statutes governing IP transactions
- Crafting agreements with individual scientists or academic departments
- addressing challenges of communicating with and managing faculty
- Contrasting the three main types of agreements with universities
- material transfer agreements
- licensing
- research collaborations
- Balancing interests in confidentiality v. publication rights
- why this can be a deal-breaker
- Demystifying the legal, regulatory and tax restrictions unique to academia that impact the contract terms
- Effectively negotiating contested issues with academic institutions:
- ownership of IP
- responsibility for patent costs covering joint inventions
- rights to improvements
- exclusive commercialization rights
- sublicensing provisions
- pricing issues
- indirect costs for sponsored research
- allocation of risk
- Setting royalty terms
10:15 Morning Coffee Break
10:30 Exploring Perspectives of Innovative Small Companies on the Industry’s Prospects for 2012 and Beyond
Gregory Miller
Head, Business & Corporate Development
CoNCERT Pharmaceuticals (Lexington, MA)
Julia C. Owens
Senior V.P. Corporate Development and Strategy,
Lycera (Plymouth, MI)
Wendy Tsai
Founder and VP Alliances,
Cellona Therapeutics (Highland, MD)
Moderator: Hemmie Chang
Partner,
Foley Hoag LLP (Boston, MA)
Small companies with limited assets operate in a different world from their larger brethren in the life sciences. In this session, you will hear executives from growing young biotech and pharma companies share first-hand industry insights and outline their current outlook and strategies.
- Addressing how small companies are coping with the current financial markets
- Illuminating the specific concerns and pressures they face from investors
- protecting the company’s credibility and stock price
- dilution issues for early providers of capital
- Assessing how small companies weigh potential partnerships
- evaluating potential partners
- looking beyond big pharma for other funding sources
- preferences for deal structuring
- straight licensing or equity investment
- timing of payments
- Granting rights and powers to new business partners vs. maintaining control
- Negotiating with larger companies interested in ultimate M&A
11:45 Bridging Gaps Between Buyers and Sellers: Finding the Right Valua on and Closing the Deal
Bradley Prosek
Senior Director,
Cubist Pharmaceuticals (Lexington, MA)
York M. Faulkner
Partner,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Reston, VA)
- Identifying the core deal asset
- determining what you are essentially trying to acquire
- Factoring industry trends into the analysis
- current environment for early stage programs
- R&D cutbacks
- growth of middle-class consumer markets in emerging nations
- anticipated market forces
- Ensuring that expectations about a deal are driven by realistic valuations based on applicable models
- devising appropriate and useful models for establishing valuation:
- for early-stage v. late-stage compounds
- distinguishing between buyer and seller valuation
- using comparables as a basis for value
- establishing what to do if there are no comparables
- Understanding the different components that contribute to valuation and ensuring that there are no disconnects
- providing for sufficient consideration of:
- primary patents
- regulatory approvals
- manufacturing rights and know-how
- other ancillary IP
- looking at assets of public companies vs. private
- Negotiating the gap between buyer and seller
12:30 Networking Luncheon for Speakers and Delegates
1:45 Overcoming Nego a ng Hurdles in Developing Profi table Public-Private Deals
Peter Weinstein
Corporate Counsel, Intellectual Property,
Baxter Healthcare (San Diego, CA)
Karin K. Rivard
Partner, G
oulston Storrs (Boston, MA)
- Understanding the underlying drivers for more deals involving public entities
- Examining differing negotiating methods and how the culture clash will impact on negotiations
- Assessing the government’s complete agenda and motivation in attracting investment
- anticipating forthcoming issues relating to drug pricing
- concealed drug development goals that could create problems
- Comparing partnering approaches taken with government institutions in different countries
- analyzing different respective attitudes towards PPPs in key emerging regions
- where the governments are offering incentives to spur investment
- attitudes relating to licensing
- Overcoming deal hurdles where there are public goals that may not align with strategic interests of the private sector
- key licensing issues that may arise
- exclusivity
- dealing with IP owned by the foreign government
- concerns relating to data sharing and protections
- Techniques for dealing with bureaucracy in the initial negotiating phase
- Strategies for resolving conflicts of interest and negotiating mutually beneficial agreements
- methods for building trust early in the negotiation phase
- facilitating open communication
- tools for fostering a sense of common purpose
- agreeing on what expertise will be contributed by the private sector
- managing IP protection issues
- addressing sub-licensing in the agreement
- setting mutually agreeable terms for risk allocation
2:45 A ernoon Refreshment Break Advanced Dra ing Strategies
3:00 “No Regrets” Dra ing: Terms to Include at the Onset that Facilitate Product Commercializa on and Profitable Coopera on between Partners
Mr. Jeffrey D. Osterman
Partner
Weil, Gotshal & Manges LLP
Charan J. Sandhu
Partner,
Weil, Gotshal & Manges (New York, NY)
- Considering a partner’s strengths and weaknesses and determining what unique clauses may help counter the likelihood of any missteps
- Creating terms to help ensure your collaborative product is developed and/or effectively marketed
- tailoring effective deal-specific terms for incentivizing the other party
- setting benchmarks and the methods for resolving changing circumstances identifying the right people to move the deal forward
- incorporating provisions for overcoming anticipated regulatory hurdles
- including compliance with recordkeeping and reporting requirements
- Using best practices for establishing clear milestones, deliverables and financial obligations
- cost/profit sharing
- co-development and co-promotion allocation
- equity/loans
- royalties
- novel structures that work
- leveraging risk by incorporating performance-based payment dates
- Providing for how the parties will defend against lawsuits and complaints
- Avoiding terms in agreements that can be potential product killers
- drilling down to what the respective parties are being permitted to do in terms of product development and marketing and anticipating where things can go wrong
- Helping to ensure that the parties can get along by:
- assigning parties’ roles to ensure a clear decision making process
- territorial vs. functional allocations
- assigning the right tasks to the right people in the right organization
- determining when it makes sense to have joint control
- assessing risks and benefits of giving control to one party
- implementing a dispute resolution mechanism
4:00 Building Strategic End Value into Your Agreement
Jerry Cohen
Partner,
Cohen Tauber Spieveck & Wagner P.C. (New York, NY)
Timothy X. Witkowski, M.S., J.D.
Executive Director & Executive Counsel, Intellectual Property
Boehringer Ingelheim (Ridgefi eld, CT)
- Positioning transactions as part of a process that can lead to a positive exit for key stakeholders
- understanding expectations of investors
- Assessing potential deal timeframes and each party’s short vs. long-term goals
- is one of the parties seeking to be acquired?
- are options to acquire equity part of the deal structure?
- Predicting how long it will take to accomplish your strategic goals
- Factoring in potential changes in strategy necessitated by market conditions
- product approval setbacks
- length of product cycles
- regulatory changes
- competition
- Clearly defining circumstances that warrant termination
- at-will
- convenience
- for breach - curable and non curable
- change of control
- under what circumstances can you terminate without a breach?
- Drafting unwind provisions to ensure a smooth transition
- reversion rights
- related compensation considerations
- ownership of IP rights – who retains them in the event of termination?
- partial termination issues
- obligations to transfer programs
- Understanding what safeguards must be included in the agreement in regards to the current economic environment
- Retaining value to the product at the end of the day
- Determining the effects of termination on existing sublicenses
- Strategies for enforcing cooperation in the event of termination
- Areas of conflict that can lead to litigation and how the right termination provisions impact relative positions in lawsuits
4:45 Conference Ends
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