9:00AM-10:00AM

Life Sciences IP Update

William Gaede & Bhanu Sadasivan

McDermott Will & Emery

This year-in-review segment will discuss: The narrowing scope of patent-eligible subject matter; How commercial manufacturing method patents may be exempt from infringement under Section 271; Indirect infringement, even where no one directly infringes; Liability for selling a method in the United States even if performance of the method is off shore; Settlements and Hatch-Waxman suits (the FTC Is watching).

10:30AM-11:15AM

FDA Update: Drugs, Biologics, Medical Devices

Elaine Tseng & Michael Petty

King & Spalding LLP

Recent months have brought substantial changes in law and regulation affecting life sciences companies. This session will identify and discuss practical implications for pharmaceutical, biotechnology, and medical device companies of key provisions of new laws, including the Food and Drug Administration Safety and Innovation Act, and current trends in regulation and enforcement, including in the areas of cGMP and quality systems. We will also draw on our experience working with various types of companies, as well as our recent experience in-house, to provide tips to aid in-house counsel in communicating and working collaboratively with internal business clients.

11:15AM-12:00PM

FDA and Off-Label Extensions

Karl Nobert

Squire Sanders

1:30PM-2:15PM

Inbound Development and Licensing issues for Medical Device and Biotechnology Companies

E.A. Lisa Kenkel & Jake Handy

Fenwick & West LLP

Successful development and in-licensing relationships are critical to building value in a medical device or biotechnology company. Understanding and avoiding common pitfalls is key to an effective strategy for development and in-license agreements. A discussion of practical tips to securing solid, lasting rights which can be exploited by the company, its collaboration partners and acquirers.

2:20PM-3:05PM

Congratulations, You Have Marketing Approval! Now What? How to Manage Risk and Extract Value Through Your Commercial Agreements

Tom Duley

DLA Piper

Commercial distribution and sale of drugs, diagnostics and medical devices presents a special set of challenges that are different from those that arise during product development. This presentation will explore the range of agreements that govern the commercialization phase in the life sciences industry, including agreements for co-promotion, supply, distribution (domestic and ex-U.S.), services (e.g., billing) and pharmacovigilance. We will focus on key take-aways and best practices to help you manage the complex and often overlooked issues that arise from the distribution and sale of your drug, diagnostic and medical device products around the world, with an emphasis on real-world examples.

3:25PM-4:10PM

Understanding Privacy and FTC Enforcement in the Life Sciences Sector

Andrew Serwin

Foley & Lardner LLP

A discussion of privacy, FTC enforcement issues, behavioral advertising, cyber-security, and many other topics related to information, and its emerging role in today's economy.

4:15PM-5:00PM

FCPA Update 2012 for Life Science Companies

Lee Rubin

Mayer Brown LLP

This presentation will discuss: Key elements of FCPA; Enforcement of FCPA in the healthcare industry; How to avoid or minimize liability; Impact of Dodd-Frank; The future of FCPA.