Life Sciences


PRACTICE AREA ATTORNEYS
DENNIS J. ALESSI
WILLIAM S. BARRETT
GORDON C. DUUS
ARTHUR D. GROSSMAN
STEVEN A. HOLT
MICHAEL A. SAFFER
PETER H. TANELLA
The attorneys in the Life Sciences Practice Group have experience in:
  • Product development and manufacturing and marketing of new products, including investigational and marketed product applications, labeling development, risk management and related FDA dialogue.
  • Product and technology licensing transactions.
  • Joint-Development, Collaboration, Cost Sharing and Risk Allocation agreements.
  • Product supply, manufacturing and distribution arrangements.
  • Product and business unit acquisition and divestiture.
  • Domestic and International commercial contract negotiation.
  • Defending companies in criminal and civil investigations and enforcement actions.
  • Litigating complex multijurisdictional tort and contract disputes involving pharmaceutical, medical device and biologic products.
  • Creation and preservation of intellectual property and the related challenges of life sciences businesses.
  • Compliance with state, federal and international laws that affect life sciences, such as the Federal Food, Drug, and Cosmetic Act; the Prescription Drug Marketing Act; the Food and Drug Administration Modernization Act; the Prescription Drug User Fee Act; the Medical Device User Fee and Modernization Act; the Controlled Substances Act; the Controlled Substances Import and Export Act; the Medicare Modernization Act; the Health Insurance Portability and Accountability Act of 1996 (HIPAA); the False Claims Act; Hatch-Waxman and the Anti-Kickback Act.
  • Development of compliance training sessions on life sciences compliance matters and legal and government enforcement trends.
  • Drug labeling, promotion, packaging, and cGMP issues.
  • Development of standard operating procedures and compliance policies.
  • Entity formation and start-up financing.
  • Corporate governance and compliance issues.
  • Venture capital and other financing structures.
  • Employment and union labor issues.
  • Manufacturing facility real estate, tax and environmental issues.
  • Tax planning and litigation.

Our Life Sciences Practice Group represents clients in the life sciencesindustry on a broad range of complex business, legal and regulatory issues including technology development and commercialization, technology licensing, manufacturing and distribution arrangements, research collaborations, technology transfers, product and business unit acquisitions and divestitures, regulatory compliance and domestic and international protection of their intellectual property rights (including preparation and prosecution of patent applications and registration of trademarks).  We also help clients protect and enforce their intellectual property rights in court and defend our clients when intellectual property claims are raised against them.  Our corporate attorneys also provide assistance with entity formation, corporate governance matters, funding and capital investment issues, corporate mergers and acquisitions, and related general business matters.

Lawyers in our Life Sciences group are experienced in counseling clients on the complex legal and regulatory issues which govern their business.  We understand how critical it is to know a client’s business and the unique pressures impacting it.  Our life sciences attorneys work with clients to understand their businesses and employ our experience to help implement practical solutions that contribute to the bottom line and allow them to focus on the business of developing and delivering innovative products and services that improve people’s health and well-being around the globe.