Regulatory Due Diligence: Ensuring Full Term Investment Success

Transactions involving the acquisition of FDA-regulated firms and/or the licensing of products present unique challenges during the due diligence process. This session focuses on best practices and real-life examples of pitfalls that make or break the deal as they relate to intellectual property issues, clinical research, and regulatory requirements including:

• Projecting the scope of exclusionary rights on the product
  
• How the “useful” life cycle of a patent impacts transaction value and associated risks
  
• Evaluating the risks associated with patent litigation with respect to small molecules and follow-on biologics
  
• Understanding the clinical research and development program – how to maximize potential for success
  
• What can go wrong with clinical trials and practical suggestions to ensure compliance
  
• Identifying critical aspects of FDA regulatory authority relative to a diligence review
  
• Determining regulatory pathways towards product approval
  
• Prospecting opportunities to increase product life cycles

Presenters included:

• Ken Appleby, Of Counsel, Tax & Individual Planning Practice, Foley
  
• Gretchen Brodnicki, Dean for Faculty and Research Integrity, Harvard Medical School
  
• David Rosen, Co-Chair, Life Sciences Industry Team, Foley
  
• Larry Vernaglia, Partner, Regulated Industries Practice, Foley