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
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