Established in 2002, the Research Triangle Park office of K&L Gates was formed to respond to the unique profile and legal needs of businesses located in the largest research park in the United States. The Research Triangle Park is a globally prominent 7,000 acre high-technology research and development center that is home to more than 200 companies– from Fortune 100 multinational research and development operations, to university spin-outs and start-up operations. The success of the Research Triangle Park reflects its close, strategic proximity to three world-class research universities located in nearby Durham, Raleigh and Chapel Hill, North Carolina.
The principal areas of practice in the Research Triangle Park office include health care, life sciences, FDA, corporate transactions, public finance, and litigation. Our health care practice and members of the team in the Research Triangle Park office have consistently been awarded a Band 1 ranking by Chambers USA Healthcare. We are listed in Modern Healthcare as one of the 20 largest dedicated health care practices in the U.S., and our health care practice is recognized with a national first-tier ranking in the 2018 edition of the U.S. News-Best Lawyers rankings of “Best Law Firms”.
A focal practice of the Research Triangle Park office is health care, with one of the largest health care advisory teams in the Southeast serving a national client base. Our health care practice is consistently ranked as a leading health care law provider by U.S. News-Best Lawyers. Our team provides legal and professional consulting services to a wide spectrum of clients, including academic medical centers and research institutions, hospitals and health systems, pharmaceutical companies, long term care facilities, physician groups, and numerous specialty providers. Our health care team assists clients on the full array of legal issues facing health care providers in an ever-changing and highly complex, regulated industry. We are also available to clients who only require selective support or particular specialty experience. Our services include representation in certain core service lines: regulatory, transactional, operational/risk management, and litigation. Our regulatory know-how in the areas of fraud and abuse, false claims, Stark, and related reimbursement matters is nationally recognized. These offerings are augmented by the availability of in-house resources for public-to-private conversions, multi-provider system development, mergers, acquisitions, scope of assistance on patient care, medical staff, The Emergency Medical Treatment and Labor Act (EMTALA) and other operational concerns. Litigators within our health care practice also represent clients on a wide range of matters at all state and federal levels, including certificate of need, licensure and certification, reimbursement, medical staff, and managed care disputes.
In 2018, our national lawyers were recognized by U.S. News-Best Lawyers for their work in Biotechnology Law. In the area of life sciences, our corporate and health care lawyers serve a diverse client base, encompassing clinical research organizations, biotechnology, pharmaceuticals, diagnostics, health care, biomanufacturing, agricultural sciences, medical devices, and information technology. Our clients range from multinational biotechnology enterprises to mid-market U.S. and foreign publicly traded pharmacogenomics companies to local emerging growth drug discovery companies. Our legal services run the gamut of issues affecting this industry segment, including assistance on mergers and acquisitions, joint ventures, corporate finance, development and research agreements, compliance audits, and privacy matters.
Our Food, Drugs, Medical Devices and Cosmetics (FDA) practice focuses on counseling corporations and individuals on all aspects of Food and Drug Administration (FDA) regulatory and corporate matters, primarily in the area of pharmaceutical, medical device, and food regulation, as well as related corporate transactional activities. One of our lawyers previously served as in-house General Counsel for an international pharmaceutical company, with responsibilities for all legal activities, regulatory affairs, quality assurance, corporate compliance, and litigation oversight. We have represented clients before the FDA, Drug Enforcement Administration (DEA), North Carolina Department of Agriculture, and various State Boards of Pharmacy, supervised the filing of numerous Abbreviated New Drug Applications (ANDAs), 505(b)(2) non-disclosure agreements (NDAs), Citizen Petitions, and other regulatory filings, and our corporate transactional experience includes negotiation and drafting of licensing, supply, distribution, and asset purchase agreements related to FDA-regulated products and pricing. Additionally, we represent pharmaceutical manufacturers on government price reporting, compliance, and contracting matters related to the Medicaid Drug Rebate Program, 340B, and Veterans Affairs (VA) regulatory programs.
Lawyers in our Research Triangle Park office also counsel clients with respect to public finance transactions. Our lawyers have extensive experience in guiding nonprofit hospital and continuing care retirement community clients through the tax-exempt bond issue process. In addition to serving as borrower’s counsel, we also have served as underwriter’s counsel and special disclosure counsel. Our lawyers have worked on public finance transactions that, in the aggregate, total over several billion dollars.