Overview
Kate Hardey is a corporate partner in the Washington, D.C., office of Kirkland & Ellis LLP. Kate is an experienced attorney with a focus in a broad range of healthcare transactions and regulatory matters. With her extensive law firm, in-house and healthcare industry experience, Kate has a deep understanding of the complex regulatory landscape affecting companies in the healthcare provider and life science space including pharmaceutical and medical device manufacturers, laboratories, pharmacies, physician groups and hospital systems.
Kate has extensive experience providing transaction and regulatory compliance advice to companies with FDA-regulated products including, human and animal pharmaceutical products, medical and digital health devices, cosmetics, over-the counter (OTC) and dietary supplement products, and food and beverage products. Kate routinely evaluates FDA compliance requirements for all aspects of drug and device product life cycle including product development and clinical trials, product classification, product sales and marketing, manufacturing and product recalls. Kate also routinely advises clients on a broad range of healthcare-related issues including pharmacy compliance, corporate practice of medicine and dentistry and general fraud and abuse matters, such as the Anti-Kickback Statute and the Stark Law and other related regulatory matters.
Kate's in-house experience includes serving as Senior Regulatory Counsel at a leading middle-market healthcare lender where she advised on healthcare regulatory risks for a wide range of pharmaceutical, medical device, technology and provider transactions. Kate also served as in-house legal counsel in a large health system, where she served on hospital boards and leadership teams. In this role, Kate counseled hospital clients on a wide range of legal issues including physician contracting, medical staff compliance, pharmacy compliance, patient privacy and patient care matters.
Kate's healthcare industry experience includes managing physician practices where she oversaw all aspects of the practice's billing and coding compliance and managed care contracting. In addition to her physician practice management experience, Kate served as the emergency department administrator at a major academic medical center where she was responsible for the department's EMTALA compliance, physician contracting, financial and strategic planning and hospital emergency preparedness.
Kate was recognized in the 2023 Southeastern Legal Awards as one of the Most-Effective Deal-Makers. In September 2022, she received the M&A Advisor award for Healthcare/Life Sciences Deal of the Year. Kate is regularly called upon to advise on large corporate transactions in connection with major acquisitions and mergers undertaken by private equity and strategic acquirers in the healthcare provider, healthcare services and life sciences platforms.
Experience
Representative Matters
Life Sciences
- Vyaire Medical in the sale of the Vyaire Respiratory Diagnostics (RDx) business unit, a manufacturer of respiratory diagnostic products, to Trudell Medical Limited
- Eli Lilly and Company (NYSE: LLY) in its $3.2 billion acquisition of Morphic (NASDAQ: MORF), a biotechnology company
- Ingersoll Rand Inc., a global provider of mission-critical flow creation and industrial solutions, on the $2.325 billion acquisition of ILC Dover from New Mountain Capital
- Dechra Pharmaceuticals in its $520 million acquisition of Invetx, a provider of protein-based animal health therapeutics, from Novo Holdings
- CapVest Partners-backed Calyx in its $115 million acquisition of Invicro, a provider of imaging biomarker services, from REALM IDx
- Phibro Animal Health Corporation (NASDAQ: PAHC) in its pending $350 million acquisition of medicated feed additive and water soluble product portfolios from Zoetis (NYSE: ZTS)
- CapVest Partners-backed Calyx in its $115 million acquisition of Invicro, a provider of imaging biomarker services, from REALM IDx
- Montagu Private Equity in its $700 million acquisition of the Medical Device Components business from Johnson Matthey (LSE: JMAT)
- Carlisle Companies (NYSE: CSL) in its $2.025 billion sale of Carlisle Interconnect Technologies to Amphenol (NYSE: APH)
- AbbVie (NYSE: ABBV) in its $8.7 billion acquisition of Cerevel Therapeutics (NASDAQ: CERE), a neuroscience drug company
- Nordic Capital in its acquisition of IntegriChain, a platform for pharma commercialization and market access, from Accel-KKR
- KKR- and Everstone Capital-backed Slayback Pharma, a provider of generic and specialty pharmaceutical products, in its sale to Azurity Pharmaceuticals.
- Eli Lilly and Company (NYSE: LLY) in its $1.4 billion acquisition of POINT Biopharma (NASDAQ: PNT), a radiopharmaceutical company
- FFL Partners in its investment in Johnson County Clin-Trials, a clinical research site platform serving pharmaceutical and biotechnology companies and contract research organizations
- THL Partners in its investment in Red Nucleus, a provider of strategic services across the entire life sciences product cycle
- GTCR in its pending $627 million acquisition of Surmodics (NASDAQ: SRDX), a provider of medical device and in vitro diagnostic technologies
- Avista Healthcare Partners in its acquisition of Trillium Health Care Products, a contract development and manufacturing organization of branded over-the-counter products, from New Water Capital
- Aterian Investment Partners in the recapitalization of CPL, a contract development manufacturing organization (CDMO) of non-sterile liquid and semi-solid dosage forms
Healthcare Technology
- Bansk Group in its acquisition of Foundation Wellness, a provider a consumer health & wellness platform for orthotics and other footcare-focused solutions, from Gridiron Capital
- GTCR-backed Cloudbreak Health in its acquisition of Voyce, a provider of language interpretation services
- GTCR on the proposed $180 million acquisition of Cloudbreak Health, LLC, a leading provider of tech-enabled, healthcare-focused language interpretation services
- L Catterton in its $680 million acquisition of Thorne HealthTech (NASDAQ: THRN), a provider of health and wellness solutions
Food & Beverage
- Wind Point Partners in the sale of Handgards, a provider of disposable food safety and hygiene-oriented products for the foodservice industry, to Wynnchurch Capital
- SKKY Partners in its investment in TRUFF, a brand of premium condiments and truffle infused products
- Clayton, Dubilier & Rice in its pending EUR 16 billion acquisition of Opella, a provider of over-the-counter drugs and vitamins, minerals and supplements, from Sanofi (XPAR: SAN; NASDAQ: SNY)
- Sycamore Partners in its acquisition of Playa Bowls, a super fruit bowl franchise restaurant, from Tamarix Equity Partners and Pacific General
Prior Experience
Partner, McGuireWoods LLP
Senior Counsel – Healthcare Regulatory, GE Capital Healthcare Financial Services
Hospital Counsel, MedStar Health
Pro Bono
More
Thought Leadership
Press Mentions
Quoted, “Healthcare Policies to Watch in the New Trump Administration,” The Wall Street Journal, November 14, 2024
Recognition
Recognized in American Lawyer Media as a “Most Effective Deal-Maker,” June 2023
Received the M&A Advisor’s Healthcare/Life Sciences Deal of the Year Award 2022 for advising Canadian cannabinoid investment company Cronos Group on its strategic investment in PharmaCann Inc., one of the largest privately held and vertically integrated cannabis multistate operators in the United States
Recognized in North Carolina Lawyers Weekly as “Leaders in the Law,” November 2020
Recognized in The National Law Journal as a “Cannabis Law Trailblazer,” September 2020
Credentials
Admissions & Qualifications
- 2004District of Columbia
- 2018North Carolina
- 2003Virginia
Education
- Catholic University of AmericaJ.D.cum laude
- Marymount UniversityM.S., Healthcare Administration
- George Mason UniversityB.A., English