POST-CONFERENCE MASTER CLASS Wednesday, Feb. 29, 2012
9:00 a.m. to 3:30 p.m. (Registration at 8:15 a.m.) Continental breakfast will be served
Life Sciences M&A/Strategic Alliances Due Diligence Boot Camp
When negotiating an acquisition or significant alliance, the diligence review team must be confident that there will be no impediments to commercializing the IP that is being gained as part of the deal. This in-depth session will help ensure that you make informed decisions regarding how the IP at issue will increase the company’s overall value, either by expanding product lines or entering new markets. Special attention will also be paid to antitrust and other legal risks that may occur when the diligence process fails to sufficiently identify areas of current government concern and inquiries.
9:00 Understanding and Contrasting the Different and Changing Metrics for M&A
Timothy R. Howe, Ph.D., JD, CLP
Vice President, Legal Affairs
General Counsel and Head, Aquisitions and Licensing Transactions
Sanofi Pasteur Inc.
- Examining the multiple ways companies are structuring current M&A deals
- straight-forward asset purchases
- staged acquisitions
- hybrid transactions
- options built into partnerships
- Drilling down into how deals are being uniquely tailored to meet both parties’ objectives
- pros and cons of two-step vs. one-step vs. multi-step stages acquisitions
- milestone-based M&A
- partnering with equity investment
- spin-offs
- reverse spin-outs
- Navigating challenges raised by the increasing incorporation of options into deals
- understanding different option structures and timelines
- dissecting the complexities of how asset shares are valued in cases of stock purchases
- Identifying when change of control provisions are often used or appropriate for nontraditional M&A
- Contrasting what risk protections can be included in different types of deal structures
- Viewing different M&A templates from an IP buyer and seller perspective
9:45 Morning Coffee Break
10:00 Mitigating Global Antitrust and other Legal Risks Presented in Life Sciences M&A
Christine L. White
Staff Attorney, Federal Trade Commission,
Northeast Regional Office (New York, NY)
Jeffery D. Williams
Vice President,
Pfizer Inc. (New York, NY)
Adam Siegel
Partner,
Freshfields Bruckhaus Deringer LLP (New York, NY)
Eric J. Stock
Partner,
Hogan Lovells (New York, NY)
- Conducting a baseline legal risk assessment
- finding and utilizing appropriate resources for your inquiry into:
- FCPA/anti-corruption/anti-kickback
- labeling/marketing violations
- products liability
- manufacturing/employment
- Identifying potential antitrust risks
- deciphering the criteria the FTC uses in their analysis
- how to verify the deal early on in order to save time
- presenting complete information to aid in the FTC’s review
- determining what assets need to be disclosed
- understanding what factors the Commission looks at
- surveying recent enforcement initiatives in the EU and Asia
- Tips for the legal diligence team:
- assembling the right people on the team
- identifying wants/needs/must-haves and deal-breakers
- determining level of exposure
- What to do if legal issues are uncovered
- taking remedial action
- knowing when to walk away
- Protecting yourself in the definitive agreements
- reps and warranties
- indemnification
- Incorporating lessons from the diligence process to facilitate ultimate integration
11:15 Creating a Practical and Useful Checklist that Incorporates Both the Business Objectives of the Deal and a Comprehensive IP Assessment
Nicholas M. Boivin
Director, Intellectual Property Counsel
Cubist Pharmaceuticals (Lexington, MA)
Mary Catherine Di Nunzio
Head of Global Patent Alliances,
H. Lundbeck A/S (Copenhagen, Denmark)
- Ensuring that the driving force behind the deal and the objectives of the diligence review are properly aligned
- knowing what the deal makers are looking for and what “IP due diligence” means to the parties
- avoiding runaway patent diligence disconnected from the strategy of the deal
- Determining the appropriate scope and depth of IP due diligence necessary for:
- large scale mergers and acquisitions
- purchase of a division or product
- co-promotion or co-development alliance with purchase options
- Ensuring that non-patent IP is not overlooked
- properly valuing trade secrets
- assessing corporate security issues
- knowing what you must look for relating to key employees
- Updating the checklist based on the type of the transaction
- adjusting to the size of the deal
- scope of the patent portfolio
- challenges in examining enforceability of international IP components
- documents to request and review with respect to early stage research progress and clinical trials
- Including an analysis of competition in the patent review
12:15 Networking Luncheon for Speakers and Delegates
1:30 Resolving Ownership Rights and Inventorship Issues Arising Under the Target’s Prior Contractual, Third Party and Licensing Obligations Which Could Impact Your Deal
Richard W. Bork
Corporate Patent Counsel,
Novo Nordisk (Princeton, NJ)
Stephen B. Maebius
Partner,
Foley & Lardner LLP (Washington, DC)
- Surveying relevant current legal standards of inventorship
- new definition of “joint inventor” under AIA and impact on ownership
- relaxation of inventorship correction procedures under AIA
- Bayh-Dole requirements in light of −Stanford v. Roche
- Identifying the IP and patents at issue and projecting how the target’s prior agreements can affect the value and terms of the transaction
- verifying right of target to sublicense IP acquired from target’s prior agreements
- determining who invented what and what rights have been granted to third parties
- addressing concerns related to collaborative, contract, and sponsored
- research agreements special issues arising under consultancy and employee agreements
- Determining whether or not the target owns or has adequate rights in the patent estate and proprietary technology
- who is the owner of record?
- doing a title search are there any existing liens on the target’s IP and how can they be cleared pre-closing?
- making certain that the target company can convey clear title −and what to do when they can’t to keep the deal on track
- Uncovering whether the target’s patents have been properly maintained in compliance with statutory requirements
- Employing techniques for clearly documenting what entities are involved and who owns what
2:30 Ethical Considerations in Protecting Privileged Documents and Confidential Information
John Garde
Partner,
McCarter & English, LLP (Newark, NJ)
- Identifying potential sources of privileged information
- attorney
- client privilege
- under direction of counsel
- anticipation of litigation
- attorney
- client communications
- opinions
- Avoiding breaches of privilege
- minimizing risks of inadvertent disclosure
- responding to requests during due diligence
- employing effective techniques for labeling of documents
- determining what information is appropriate to communicate
- Understanding the potential contractual and legal remedies when breaches occur
- Implementing best practices for protection of valuable IP assets during negotiations
- making appropriate use of confidentiality agreements
- techniques for effective document control and other security measures
- Use of non-competes
- defining what constitute competing products
3:30 Master Class Concludes
Conference Details