Nathan A. Beaton

Regulatory

Nate regularly counsels at all stages of the product life cycle, including on:

• Pre-market regulatory interactions and product submissions
• Clinical trials and pre-clinical testing
• Non-patent exclusivity
• Good manufacturing practice
• Promotion and labeling
• Inspections and recalls
• Post-market regulatory interactions and appeals
• Enforcement actions

Transactional

Nate’s recent transactional experience includes representing:

• Momenta Pharmaceuticals in its US$6.5 billion acquisition by Johnson & Johnson
• The Carlyle Group and Ortho Clinical Diagnostics, a UK-organized, Nasdaq-listed global leader in in vitro diagnostics, in Ortho’s merger with Quidel, valuing Ortho at approximately US$6 billion
• Nordic Capital in its investment in Equashield, an Israeli-based, leading global provider of closed-system transfer devices
• Goldman Sachs in Lyell Immunopharma’s US$425 million initial public offering (IPO)
• Sight Sciences in its US$240 million IPO
• Revolution Medicines in its US$300 million and US$230 million public offerings

Litigation and Investigations

Nate’s recent litigation and investigations experience includes representing:

• Fontem in litigation concerning a denial of its marketing application, in which the US Court of Appeals for the District of Columbia Circuit vacated the denial as unlawful under the Federal Food, Drug, and Cosmetic Act and arbitrary and capricious under the APA
• Catalyst Pharmaceuticals in litigation concerning approval of a competitor’s drug due to Catalyst’s orphan drug exclusivity, in which the US Court of Appeals for the Eleventh Circuit reversed the district court and directed judgment in Catalyst’s favor
• Genus Lifesciences in litigation regarding an FDA patent certification, in which the US District Court for the District of Columbia concluded that the FDA erred during its approval of a competitor’s product and granted partial summary judgment in favor of Genus
• An international biopharmaceutical company in a review of whistleblower allegations regarding the company's public disclosures of clinical data and FDA interactions
• A pharmaceutical company in an internal investigation of alleged misconduct by a principal investigator during a clinical trial