Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain insights on navigating FDA regulations, understanding the M&A Safe Harbor, cybersecurity risks, and the impact of recent legal decisions on FDA-regulated transactions. This concise session will end with an engaging Q&A session with industry leaders.

Program Schedule:

10:00 – 10:30am Smart Due Diligence: Navigating FDA Regulations with Confidence

Nate Downing will offer regulatory insights for due diligence on both sides of an acquisition. He will discuss how to issue spot concerns that can make or break your deal.

10:30 – 11:00am Is Honesty the Best Policy? Exploring the M&A Safe Harbor

Amanda Johnston will discuss the DOJ’s Mergers & Acquisitions Safe Harbor Policy, which aims to incentivize acquiring companies to disclose misconduct uncovered during the M&A process. This new Safe Harbor emphasizes the critical role of healthcare compliance in due diligence activities. The session will detail the policy's requirements and explore potential downstream effects on M&A activity and due diligence strategy in the FDA-regulated industry.

11:00 – 11:30am Revealing Risk: Cybersecurity Due Diligence

Paul Rothermel will explore key cybersecurity issues that can come to light during M&A transactions, from data breaches to weak cybersecurity controls, and discuss ways to identify these risks (and common pitfalls to avoid) during due diligence.

11:30 – 11:45am BREAK - LUNCH for in person

11:45 – 12:15am Exploring the Loper Decision: Impacts on FDA-regulated Transactions

David Graham will discuss the Supreme Court's Loper decision and its impact on M&A due diligence, particularly for interpreting statutes relevant to technology involved in the transaction. He'll also explore how early planning for potential FDA disagreements can benefit product approval and outline the limitations of the decision as it relates to challenges to FDA authority.

12:15 - 1:00pm Panel Discussion: In-House Counsel Perspectives

Mark Gardner will moderate a panel of in-house attorneys to discuss the topics of the day.