Rebecca H. Williams

Advertising and Promotion

• Assess regulatory compliance of advertising and promotional materials for pharmaceutical, biotech, medical device, cosmetic, and food companies.
• Develop policies and procedures governing the processes and standards for review, approval, and use of promotional and non-promotional materials.
• Counsel biopharmaceutical and medical device companies on a wide variety of product communications issues, including consistent with the label and off-label communications, social media activities, and scientific exchange.
• Represent life sciences manufacturers in competitive disputes involving false or misleading product communications.
• Advise pharmaceutical clients in responding to OPDP untitled letters.
• Conducted several compliance assessments for pharmaceutical clients’ promotional review committees, which involved employee interviews, reviewing SOPs and other internal documents, evaluating a sampling of promotional materials used by the company, and providing recommendations for improvement.
• Serve as the legal and compliance reviewer on pharmaceutical and biotech clients’ promotional and medical review committees, advising on product launch, marketing strategy, digital and print promotional materials, training materials for sales representatives, medical conference presentations and materials, and social media strategy.
• Seconded for four months to global biopharmaceutical company as an associate general counsel responsible for endocrinology and fertility therapeutic areas, leading legal issues relating to advertising and promotional review committees, as well as supporting and advising brand teams and senior leadership and drafting commercial agreements, among other corporate responsibilities.

Transactions and Offerings

• Provide regulatory counsel for corporate transactions involving drug, medical device, cosmetic, food, and dietary supplement companies. Representative transactions:
  
  • Represented Blackstone and TPG in an agreement to acquire Hologic, Inc., a developer, manufacturer and supplier of premium diagnostics products, medical imaging systems, and surgical products, in a transaction valued at up to $79 per share, representing an enterprise value of up to $18.3 billion.
  • Represented Gilead in an agreement to acquire Arcellx, a biotechnology company developing immunotherapies for patients with cancer and other incurable diseases, for implied equity value of $7.8 billion.
  • Represented Novo Nordisk in its acquisition of Akero Therapeutics, Inc., a clinical-stage company developing treatments for patients with serious metabolic diseases marked by high unmet medical need, for up to $5.2 billion.
  • Represented Novo Nordisk in an asset purchase and license agreement with Omeros Corporation for Omeros’ drug candidate zaltenibart in a deal worth up to $2.1 billion.
  • Represented Eli Lilly in its acquisition of Ventyx Biosciences, a clinical-stage biopharmaceutical company focused on developing innovative oral therapies for patients with inflammatory-mediated diseases for $1.2 billion.
  • Represented Immunogen, a biotechnology company focused on the development of antibody-drug conjugate technology to treat cancer, in its sale to AbbVie for approximately $10.1 billion.
  • Represented Elliott Investment Management, Patient Square Capital, and Veritas Capital in the acquisition of Syneos Health, a fully integrated biopharmaceutical solutions organization offering clinical research and commercialization services, for $7.1 billion.
  • Represented Becton, Dickinson and Company, a leading global medical technology company, in its $4.2 billion acquisition of Edwards Lifesciences’ Critical Care business.
  • Represented Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, in its sale to Sanofi for approximately $2.9 billion.
  • Represented Pfizer in its $6.7 billion acquisition of Arena Pharmaceuticals, a biotechnology company developing potential therapies for the treatment of several immuno-inflammatory diseases.
  • Represented Sarepta Therapeutics in global licensing and collaboration agreement with Arrowhead Pharmaceuticals for multiple siRNA programs worth up to $11.35 billion.
  • Represented Advent in its acquisition of a majority stake in Salt & Stone, a premium body-care brand.
  • Represented TSG Consumer Partners in its investment in Summer Fridays, a clean, premium skincare and hybrid makeup brand.
  • Represented Berkshire Partners in its strategic investment alongside Leonard Green & Partners in Vital Care, a leading franchisor of infusion therapy pharmacies.
  • Represented TPG Capital and Clayton, Dubilier & Rice on regulatory matters in their acquisition of Covetrus, a global leader in animal health technology and services.
  • Represented Audax Private Equity in its acquisition of the clinical services business of Avantor.
  • Represented Blackstone Life Sciences in its $2 billion strategic collaboration to support Alnylam’s advancement of innovative RNA interference (RNAi) medicines.
  • Represented GHO Capital Partners LLP in its investment in Biocare, a leading developer of world-class immunohistochemistry and in situ hybridization reagents for cancer diagnosis and chromosomal profiling.
  • Represented Prevail Therapeutics in its sale to Eli Lilly and Company to establish a gene therapy program at Lilly anchored by Prevail’s portfolio of neuroscience therapeutics to address fatal genetic forms of neurodegenerative diseases including Parkinson’s disease and neuronopathic Gaucher disease, among other disorders.
  • Represented Avista Capital Partners in its acquisition of Cossette Pharmaceuticals, a U.S.-based specialty pharmaceutical company, and its subsequent sale of a significant equity interest to Hamilton Lane.
  • Represented Blackstone Life Sciences in its acquisition of Clarus, a leading global life sciences investment firm that closed its inaugural fund with $4.6 billion in capital commitments.
• Provide FDA regulatory advice for IPOs and follow-on offerings of early and late-stage pharmaceutical and biotech companies. Representative matters:
  
  • Represented Zenas BioPharma in its $225 million initial public offering.
  • Represented Sigilon Therapeutics, Inc. in its $145 million initial public offering.
  • Represented Sprye Therapeutics, in a $275 million public offering.
  • Represented ImmunoGen, Inc. in multiple follow-on offerings.
  • Represented RVL Pharmaceuticals plc, a portfolio company of Avista Capital Partners, in its $68 million initial public offering and private placement and multiple follow-on offerings.
  • Represented lead underwriters in the $6.7 billion secondary offering of Regeneron common stock.
  • Represented underwriters in connection with the $1.34 billion registered follow-on offering of common stock of Moderna, Inc.
  • Represented underwriters in connection with the $315 million initial public offering of Bicara Therapeutics.
  • Represented lead underwriters in the $91 million initial public offering of Vigil Neuroscience.
  • Represented lead underwriters in the $72 million initial public offering of Fulcrum Therapeutics, Inc.
  • Represented underwriters in the $82.5 million initial public offering of Codiak BioSciences, Inc.
  • Represented underwriters in several debt and equity offerings for Rhythm Pharmaceuticals, 2Seventy Bio, Provention Bio, Organogenesis Holdings, Inc., and Seres Therapeutics.
• Advise pharmaceutical and medical device clients in connection with collaboration, licensing, manufacturing, and quality agreements.

Regulatory Strategy

• Advise on policies and procedures for pharmaceutical, medical device, cosmetic, and food clients, including policies governing GxP and quality activities, internal and third party audits, vendor selection, qualification and management, complaint handling, recalls and adverse event reporting.
• Advise pharmaceutical clients regarding compliance with cGMP requirements and responding to Form FDA-483 inspection observations and FDA warning letters.
• Advise pharmaceutical clients on issues related to Hatch-Waxman, orphan drug exclusivity, and new chemical entity exclusivity.
• Advise clients seeking expedited development and approval incentives.
• Conducted an internal investigation of a pharmaceutical manufacturer related to alleged noncompliance with FDA data integrity and cGMP requirements.
• Co-authored amicus brief on behalf of the Association of American Medical Colleges in support of the petitioners in the consolidated appeals U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine before the U.S. Supreme Court.
• Drafted a successful request for a priority review voucher on behalf of a biotechnology firm.
• Advised a pharmaceutical client regarding recall strategy and related regulatory and customer communications.
• Advised a medical device client regarding issues related to recall and regulatory reporting decisions.
• Advised a compounding pharmacy on compliance matters associated with the Drug Quality and Security Act and implementing FDA regulations and guidance.