Pharmaceuticals and Biologics

Representative Experience

  • Represented a manufacturer and packager of pharmaceuticals, over-the-counter drugs and dietary supplements in the negotiation of a supply agreement valued in excess of $100 million with a large, independent provider of over-the-counter products
  • Developed the cross-border distribution platform for a U.S health pharmaceutical company by crafting client’s international distribution, quality, and pharmacovigilance agreements as well as agreements for obtaining marketing authorization approvals in foreign jurisdictions
  • Counseled Canadian specialty pharmaceutical company in connection with U.S. Customs importer of record issues
  • Represented U.S. affiliate of Israeli biopharmaceutical company in connection with successful release from U.S. Customs hold of active pharmaceutical ingredient imported to the U.S. for finishing and export purposes
  • Represented pharmacy health information provider in successfully defeating emergency TRO proceedings brought by competitor in federal court for alleged trade secret misappropriation, which result was followed by prompt dismissal of all claims in suit.
  • Advised U.S. clinical stage biopharmaceutical company on cross-border distribution, quality, and pharmacovigilance agreements
  • Represented U.S. health pharmaceutical company in negotiation and execution of global supply agreement with medical device manufacturer and related global safety data exchange agreement
  • Advised U.S. life sciences company on agreements with third-party logistics providers for transport and storage of biopharmaceuticals across United States
  • Advised U.S. manufacturer of private brand OTC drugs and nutritionals on U.S. Customs rules of origin for active pharmaceutical ingredients sourced from around the world
  • Represented U.S. biopharmaceutical company in connection with supply and distribution agreements with specialty pharmacies
  • Represented U.S. specialty pharmaceutical company with the formation of its distribution platform in Mexico and Central America, including drafting of related distribution, quality, and pharmacovigilance agreements
  • Advised U.S. specialty pharmaceutical company with restructuring of its international operations through a Luxembourg holding company and drafted related interservices agreement between U.S. parent and Luxembourg affiliate
  • Assisted a Belgian biotech company to prepare submission to FDA for GRAS status of new enzyme food ingredient system.
  • Advised a European pharmaceutical company on potential regulatory approval pathways, including 505(b)(2) new drug applications, that competitor products might use for U.S. market entry. Provided ongoing research on legal strategies to maintain market share against competitor products.
  • Serves on multiple client promotional review boards for pharmaceutical and medical device companies as the legal representative to ensure  regulatory compliance of FDA's labeling and promotional requirements.
  • Counseling an Alabama-based manufacturing company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Counseling pharmaceutical companies on regulatory issues relating to 505(b)(2) new drug applications and orphan drug issues.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Serving on client review board for a North Carolina-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.
  • Counseling a California-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a Pennsylvania-based pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a New York-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Counseling a Georgia-based medical services manufacturer on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Counseling a pharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Worked with the FDA’s Office of the Ombudsman to help facilitate meetings or discussions between a pharmaceutical company sponsor and the FDA on a stalled clinical development program and when communications broke down.
  • Counseling a California-based biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Counseling a biopharmaceutical company on regulatory issues such as 505(b)(2) new drug applications and orphan drug issues.
  • Serving on client review board for a Montreal-based pharmaceutical company as the legal representative on the company’s internal committee that reviews advertising and promotional materials.
  • Counseling a Montreal-based pharmaceutical company on FDA regulation in the social media area, product promotion and clinical area, trial recruitment.
  • Assisted with due diligence for the acquisition of a pharmaceutical company.
  • Supported successful settlement of claims of trade dress infringement and unfair competition under the Lanham Act brought against a pharmaceutical company by a competitor. This case involved the unique and rarely litigated issue of whether the appearance of pharmaceutical pills and capsules are protectable as trade dress.
  • Counseled a European pharmaceutical client on market exclusivity strategies under U.S. law and FDA regulations.
  • Obtained plaintiff’s verdict on claims of misappropriation of trade secrets and breach of contract following two-week jury trial and recovered client’s property against former partner of highly specialized biotechnology company.
  • Served as counsel to a specialty pharmaceutical company in connection with the formation of a strategic alliance with a medical device development company to develop, market and sell obstetric products.
  • Served as counsel to Glades Pharmaceuticals, LLC, the generic products subsidiary of Stiefel Laboratories, in the sale of substantially all of its assets to Perrigo Company for approximately $60 million in cash.
  • Advised on takeover response strategies, including adoption of poison pills and employment agreements with parachutes for Microtek Medical Holdings, Inc., First Horizon Pharmaceutical Corporation and Profit Recovery Group International, Inc.
  • Served as counsel for First Horizon Pharmaceutical Corporation, a specialty pharmaceutical company, in its initial and follow on public offerings totaling approximately $245 million.
  • Reviewed product labeling and product claims for a pharmaceutical company manufacturing and distributing dietary supplements and over-the-counter drug products.
  • Advised start-up company in the area of hair restoration research regarding most advantageous regulatory pathway for development and marketing of biological-device combination product.
  • Advised multinational manufacturer of human biological and device products regarding approval strategies, advertising and promotional activities, and compliance issues.
  • Helped prepare a Citizen Petition, submitted by King Pharmaceuticals, a publicly traded company subsequently acquired by Pfizer, defending a challenge to the company’s sale of an approved drug product; the product remains on the market to date.
  • Represented a number of pharmaceutical clients before local FDA district offices and the FDA’s Office of Compliance to develop proactively a phase-out program of Drug Efficacy Study Implementation (DESI) products before the FDA took enforcement action against the companies.
  • Advised a pharmaceutical company on product listing and registration with the Medicaid Drug Database.