Colleen M.Heisey

Partner

Washington + 1.202.879.3449

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With more than 20 years of experience focused on Food and Drug Administration (FDA) regulated products, Colleen Heisey has a strong understanding of the legal, regulatory, and compliance issues facing drug, biologics, medical device/diagnostic, and food/dietary supplement clients. Her practice involves strategic counsel to clients navigating near-market and post-market opportunities and obligations, including matters related to product jurisdiction, pathways to market, regulatory exclusivities, accelerated approvals, orphan drug status, adverse event reporting, recalls, and managing federal agency inquiries and enforcement actions.

A business-oriented problem solver, Colleen evaluates and advises on product advertising and promotion and has helped life sciences companies launch dozens of prescription and over-the-counter (OTC) drug and device products. She has worked with regulated industries to develop and implement right-sized comprehensive compliance programs. Colleen's distinct skills and experiences are deployed to serve clients as they perform due diligence on products and targets and negotiate license, collaboration, acquisition, and other commercial agreements. She also supports robust teams in contract disputes and arbitration arising from commercial agreements involving regulated products and in litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA).

Colleen maintains an active presence in the Food and Drug Law Institute, speaking and writing for the organization, as well as serving on planning and products committees. As a first-generation college graduate, she is a proud member of the Board of Trustees of Lycoming College.

Experience

  • Astellas acquires Iveric bioJones Day is advising Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.
  • Sky Island Capital acquires Kaufhold's KurdsJones Day represented Sky Island Capital in the acquisition and financing of Kaufhold's Kurd's, Inc., a wholesale food manufacturer that primarily sells direct to food service distributors across the United States.
  • UPL sells stake in Advanta Enterprises to KKRJones Day advised UPL Limited in its $300 million sale of a 13.33% stake in its subsidiary, Advanta Enterprises Limited, to KKR.
  • CDPQ leads $125 million Series D financing of Soli OrganicJones Day advised CDPQ as lead investor in the $125 million Series D financing of Soli Organic, the nation's only soil-based, indoor farming company delivering 100% USDA certified organic produce.
  • Riverside portfolio company acquires BloodHubJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company InVita Healthcare Technologies of BloodHub, a leading software provider of blood and biologics supply chain automation solutions.
  • Eurobio Scientific acquires GenDxJones Day advised Eurobio Scientific SA in the acquisition and financing of the Dutch company Genome Diagnostics BV (GenDx) from its founder and its shareholders for €135 million (net of adjusted cash).
  • Labcorp to spin off Clinical Development businessJones Day is advising Labcorp (NYSE: LH), a leading global life sciences company, in its consideration of whether to pursue a spin-off of its Clinical Development business to its shareholders through a tax-free transaction.
  • Patent owner challenges FDA regulatory review determinationJones Day represents a patent owner in challenging the U.S. Food and Drug Administration's (FDA) regulatory review period determination for its drug.
  • STERIS sells renal business to EvoquaJones Day advised STERIS in the $196.3 million sale of its Renal Care business to Evoqua Water Technologies, a leading provider of mission-critical water and wastewater treatment solutions.
  • American Pacific Group acquires Gym Launch and Prestige LabsJones Day advised American Pacific Group, a San-Francisco Bay Area-based private equity firm, in the acquisition of Gym Launch, a provider of coaching programs and business training materials to help gym owners increase revenue and improve profitability, and Prestige Labs, a provider of premium fitness and health supplements.
  • Morgan Stanley Capital Partners portfolio company acquires MacArthur CorporationJones Day advised Morgan Stanley Capital Partners in connection with the acquisition by portfolio company AWT Labels & Packaging, Inc. (AWT) of MacArthur Corporation, a world-class manufacturer of innovative labels, tags, decals, and functional film components for the mobility, electronics, health technology, and industrial sectors.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • Riverside acquires Whittle & Mutch, Inc.Jones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company FlavorSum of Whittle & Mutch, Inc. (W&M), a fourth-generation, family-owned flavor house that manufactures and sells liquid flavors, emulsions, extracts, and other taste-related products primarily to beverage customers.
  • STERIS acquires Cantel Medical for $3.6 billionJones Day advised STERIS plc in its acquisition of Cantel Medical Corp, a global provider of infection prevention products and services primarily to endoscopy and dental customers, for $3.6 billion.
  • Morgan Stanley Capital Partners portfolio company acquires Target Labels & Packaging LLCJones Day represented Morgan Stanley Capital Partners in connection with the acquisition by portfolio company, PPC Flexible Packing LLC, of North Salt Lake, Utah-based Target Labels and Packaging LLC.
  • PWNHealth and Home Access Health Corporation sold to Everlywell, forming Everly HealthJones Day advised PWNHealth LLC and Home Access Health Corporation in its sale to Everlywell, a leading digital health company, and forming Everly Health.
  • Riverside portfolio company acquires iTakeControlJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus, a premier provider of learning, performance, and process solutions for the life sciences industry, of iTakeControl, a leading provider of clinical operations and medical affairs technology and services focused on rare disease and specialty pharma.
  • TD Securities provides $450 million acquisition financing to Whole Earth Brands, Inc.Jones Day advised TD Securities (USA) LLC, as arranger, in connection with the refinancing of a previous credit facility to include a $450 million senior secured credit facility comprised of a $375 million term loan and a $75 million revolving credit facility to Whole Earth Brands, Inc., a leading global manufacturer of natural, plant-based, clean label, and zero or low-calorie sweeteners.
  • Junshi Biosciences collaborates with Coherus Biosciences to co-develop anti-PD-1 antibody and grants options for anti-TIGIT and IL-2 cytokine moleculesJones Day represented Junshi Biosciences in its license out of technology and IP related to an anti-PD-1 antibody known as Toripalimab and options for two other molecules.
  • American Pacific Group portfolio company acquires PenetrexJones Day represented American Pacific Group in connection with the acquisition by portfolio company Wellbeam Consumer Health LLC, formerly Yukon Wellness Holdings LLC, of Penetrex, a leading joint and muscle relief and recovery brand.
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    May 2023 Alert

    FTC Signals Its Intent to Aggressively Combat Deceptive Health Claims Advertising

    March 2023 Alert

    FDA Takes Long-Awaited Action on Labeling Plant-Based Milk Alternatives

    February 2023 Alert

    FDA Announces Overhaul of Human Foods Program

    February 2023 Alert

    USDA Publishes Strengthening Organic Enforcement Final Rule

    February 2023 Alert

    U.S. National Institute of Standards and Technology Releases AI Risk Management Framework

    January 2023 Commentary

    Food, Drugs, Cosmetics, and Devices: Federal Regulatory Focus Areas in 2023

    January 2023 Alert

    The FTC Overhauls and Expands 25-Year-Old Health Products Advertising Compliance Guide

    November 2022 Commentary

    FDA Proposes Updated Definition of "Healthy" Claim for Food; Seeks Comment

    November 2022 Alert

    FDA Submits Final Food Traceability Rule in Effort to Mitigate Foodborne Illness Outbreaks

    November 2022 Alert

    FDA Proposes Updated Definition of "Healthy" Claim for Food

    View All

    Speaking Engagements

    • October 14, 2022
      Recent Trends in Enforcement and Practical Examples to Ensure Compliance (FDLI, Advertising and Promotion for Medical Products Conference)
    • March 16, 2022
      FDLI Careers Over Coffee March: Hiring Process Tips & Tricks (FDLI)
    • October 13, 2021
      Closed Doors Lead to Open Windows: Emerging Trends in Virtual Sales Force Tools (FDLI, Advertising and Promotion for Medical Products Conference)
    • September 29, 2021
      Exploring FDA’s Expedited Programs: Applicability and Eligibility (ACI’s 37th FDA Boot Camp: American Conference Institute)
    • February 4, 2021
      Fundamentals of Vaccine Regulation: Pathways to Market (FDLI)
    • October 28, 2020
      Practical Considerations for Successful Remote-Based Marketing and Compliance Strategies - Health Care Provider Access and Sales Training (FDLI, Advertising and Promotion for Medical Products Conference)
    • August 20, 2020
      How to Introduce Clients to the FDA-Regulated Space: A Sharing Session (FDLI, Law Over Lunch)
    • April 24, 2020
      Face Masks and Their Use in the Workplace (Original Equipment Suppliers Association)
    • January 2019
      Blockchain in Healthcare, New York State Bar Association Annual Meeting
    • December 4, 2018
      Drug Quality and Security Act, Title I – Inspections and Enforcement in the Compounding World (FDLI)
    • October 10, 2018
      Regulation of Medical Products in the EU and Combination Products (Drug Information Association)
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • December 9-10, 2015
      Enforcement, Litigation, & Compliance The Food and Drug Law Institute (FDLI)
    • October 15-16, 2015
      ABA/MDMA/FDLI Medical Device Law 2015
    • October 1-2, 2015
      Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries, The Food and Drug Law Institute
    • July 16, 2015
      ABA's FDA Drug Law Fundamentals, Webinar
    • November 12, 2014
      ABA's Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion webinar
    • September 10, 2014
      Presentation to Mansfield-PhRMA Fellows: How U.S. Law Firms Help Their Clients Bring Pharmaceuticals and Biologics to Market
    • May 18, 2014
      ATA Telemedicine Venture Summit 2014
    • May 6, 2014
      Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication
    • February 20, 2014
      The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society
    • November 13, 2013
      2013-2014 Life Sciences Webinar Series: Intellectual Property, Regulatory, and Antitrust Issues in Life Sciences M&A and Capital Markets Transactions
    • October 24, 2013
      FDA Fundamentals: FDA Drug Approval and Oversight, American Bar Association
    • September 11, 2013
      Healthcare Technology Approvals, Clearances and Commercialization, Angel Venture Forum’s Cyber Security & Healthcare Investment Conference
    • August 1, 2013
      Successfully Navigating FDA Citizen Petitions and Responses

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