Julea Lipiz

JULEA LIPIZ advises clients in the pharmaceutical, medical device, and life sciences industries on FDA regulatory, compliance, and enforcement matters. Drawing on her scientific background, she consults with clients across the full product lifecycle — from clinical development through postmarket compliance.

FDA Regulatory Counseling
Julea advises clients on FDA regulatory issues involving drugs, biologics, medical devices, OTC drugs, radiopharmaceuticals, cosmetics, animal drugs and biologics, and current Good Manufacturing Practice (cGMP) compliance. She also counsels clients on FDA engagement strategies.

Life Sciences Transactions
Julea provides regulatory support on transactions and corporate matters, including merger and acquisition due diligence, regulatory assessments, drafting and negotiating transactional documents, analysis of securities disclosures, and reviewing credit, licensing, quality, and loan agreements, for companies across the pharmaceutical, medical device, OTC drug, radiopharmaceutical, and cosmetic sectors. 

FDA Enforcement and Investigations
Julea represents companies in compliance and enforcement matters, including responses to Warning Letters and Form FDA 483 observations, responses to FDA information requests, and internal investigations.

Julea earned her J.D. from the University of California, Berkeley, School of Law, where she served as a senior editor of the Berkeley Technology Law Journal and an associate editor of the Berkeley Journal of Employment and Labor Law. She earned a B.S. in molecular and cellular biology and a B.A. in political science, both summa cum laude, from the University of Arizona, where she conducted research on glycoprotein trafficking at the blood-brain barrier and worked at Tech Launch Arizona on technology commercialization initiatives.

Julea’s recent matters include:

• GE HealthCare in its US$945 million acquisition of SOFIE Biosciences, a radiopharmaceutical company with 15 Contract Manufacturing Organization sites and a Contract Development and Manufacturing Organization site.
• Telix Pharmaceuticals Limited in its US$1.65 billion merger with ITM Isotope Technologies Munich SE, a radioisotope production and radiopharmaceutical development company.
• Bolt Biotherapeutics, Inc. in its acquisition of Prana Therapies, Inc., a clinical-stage biotechnology company, and a concurrent private placement financing providing US$120 million in upfront gross proceeds for the purchase of shares of Series D non-voting convertible preferred stock and up to an additional US$60 million upon exercise of accompanying warrants with a syndicate of new and existing leading healthcare institutional investors.
• Werewolf Therapeutics in its merger with Ambros Therapeutics and concurrent US$150 million private placement.
• MacroGenics, Inc. a biopharmaceutical company focused on developing antibody-based cancer therapeutics, in its US$122.5 million sale of its good manufacturing practice drug substance operations to Bora Pharmaceuticals Co., Ltd.
• AIP in its US$1.272 billion acquisition of Avanos Medical, a medical device company with products focused on Specialty Nutrition Systems and Pain Management and Recovery.
• ARCHIMED in its US$1.1 billion acquisition of Esperion Therapeutics, a commercial-stage biopharmaceutical company focused on cardiometabolic and rare/orphan disease therapies.
• GE HealthCare in its US$2.3 billion acquisition of Intelerad, a medical imaging software company specializing in enterprise workflow solutions.
• Astria Therapeutics in its US$920 million acquisition agreement with BioCryst Pharmaceuticals, expanding Astria's portfolio of therapies for allergic and immunologic diseases.
• Sagard Healthcare Partners in providing up to US$250 million in non-dilutive financing to Nuvation Bio, a global biopharmaceutical company focused on oncology.
• RoundTable Healthcare Partners in its investment in Colorescience, a skincare brand specializing in sun protection products.
• Verdane in its partnership with Smartbox, a leading provider of augmentative and alternative communication (AAC) technology.

Julea maintains an active pro bono practice. She has represented a veteran in a request for Combat Related Special Compensation (CRSC), assisted a family with custodial and financial power of attorney matters, and represented a parent in special education proceedings. She also regularly volunteers at the District of Columbia Bar's Landlord Tenant Resource Center, providing free legal information to unrepresented landlords and tenants.