Practice Areas & Industries: Greenberg Traurig, LLP

 




Life Sciences & Medical Technology Return to Practice Areas & Industries

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Practice/Industry Group Overview

The United States has historically been the global leader in life sciences and medical technology by developing life-saving and life-enhancing drugs, products and medical devices, information technology and services. The life sciences and medical technology industries are experiencing dynamic technical leaps forward, such as the sequencing of the human genome, advances in stem cell research, electronic medical records (EMR), disease management and outcomes assessment, all of which are advancing at a very rapid pace. And the future looks even brighter, with breakthroughs on the way in nanotechnology, gene-based diagnostics, a wide variety of medical devices and surgical products, management information systems, and many other developments.

Equally fundamental and rapid changes also characterize the business side of the industry. Life sciences companies face significant challenges from regulatory changes, pricing pressures and fluctuations in funding to patent protection, competition and products liability. Developments in medical technology and information systems, including rapid advances in EMR, disease and outcomes management, and systems for compiling, disseminating and organizing clinical information, are providing clinicians with the information needed to improve patient outcomes, while also containing costs without sacrificing quality care. GTs Life Sciences & Medical Technology Group provides the strategic and legal guidance to help our clients address these challenges as they continue to develop, fund and bring to market both today's innovations and those just around the corner. In conjunction with our overseas offices and strategic alliances, we are able to assist our clients in their strategic goals both domestically and around the world.

Our Life Sciences & Medical Technology Group supports clients ranging from start-ups to large multinational public companies and not-for-profit care providers, as well as investors, venture capital and private equity funds, investment banks and public agencies. Our wide-ranging work encompasses numerous industry sectors, including biomedical engineering, biotechnology, chemistry, cosmetics, dietary supplements, disease management, drug delivery, EMR, billing and coding, immunology, medical devices, microbiology, nanotechnology, pharmaceuticals, stem cells and vaccines.

We bring to our life sciences and medical technology clients a variety of services to serve their most important needs, including:

Corporate and Securities

  • Start-up and organizational matters, including corporate formation, stockholder, governance, licensing and tax matters
     
  • Assistance with many forms and varieties of capital raising, including private placements and public offerings of equity and debt securities, including venture capital and private equity transactions
     
  • Joint ventures and strategic alliances
     
  • Mergers, acquisitions and dispositions of stock and assets, leveraged buy-outs, employee stock ownership plans (ESOPs) and assistance with other exits and liquidity events
     
  • Corporate restructurings and bank financings

Intellectual Property & Technology

  • A wide range of IP services including preparing and prosecuting U.S. and foreign patent applications; copyrights and trademark matters; infringement; interference and other IP litigation
     
  • Confidentiality and non-disclosure agreements, invention assignment, and proprietary rights agreements
     
  • Strategic evaluation for maximizing value derived from IP portfolios
     
  • Licensing, collaboration, and technology transfer agreements with private industry, as well as universities, medical schools and research centers
     
  • Distribution, manufacturing and sales agreements

Health Care

  • Health Insurance Portability and Accountability Act (HIPAA) compliance including privacy, security and Electronic Data Interchange matters
     
  • Health facility licensure, accreditation, certification, survey, disciplinary, and enforcement actions and appeals
     
  • Health care provider licensure and disciplinary actions and appeals
     
  • Compliance plan development, implementation and maintenance Managed care plan licensure, accreditation and certification

Litigation

  • Patent litigation, including ANDAs and related matters
     
  • Products liability and warranty cases
     
  • Trademark enforcement
     
  • International Trade Commission (ITC) Section 337 Actions
     
  • Business disputes
     
  • Antitrust defense
     
  • Insurance recovery and counseling

Regulatory and Governmental Affairs

  • Applications for FDA approval, including new drug and Section 510(k) device approvals, and FDA compliance issues
     
  • Government contracts, grants and research agreements
     
  • Clinical research issues, including contract, consent and reimbursement
     
  • Federal and state legislative matters
     
  • Export control and technology transfer issues

Executive Compensation and Employee Benefits

  • Employment agreements and employee benefit plans
     
  • Stock option and restricted stock grant plans
     
  • Confidentiality, non-competition and assignment of inventions agreements
     
  • Consulting arrangements
     
  • Discrimination and wrongful termination litigation

Global Trade

  • Trade policies, remedies, negotiations, disputes and other commercial issues
     
  • Competition law, including antitrust, price discrimination and unfair competition
     
  • Regulatory proceedings before the International Trade Commission, the International Trade Administration of the Department of Commerce, and the office of the U.S. Trade Representative
     
  • Appeals before the U.S. Court of International Trade and the U.S. Court of Appeals

Immigration

  • Foreign highly skilled workers (H-1B special visas)
     
  • Intra-company transfers

International

  • Cross-border investment, distribution and licensing agreements
     
  • Foreign and domestic acquisitions and dispositions, leasing and management of foreign subsidiaries and assets
     
  • International tax and IP counseling

Real Estate and Land Development

  • Building financing and development
     
  • Office and facility leasing
     
  • Environmental compliance
     
  • Tax and other governmental incentives
     
  • Equipment purchases and leasing

 

Services Available

 
Past Seminar Materials
  ACI Medical Device Agreements Conference, November 19, 2013
OneMedForumConference 2013: Emerging Company Finance Conference, January 7, 2013