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430 Davis Drive, Suite 400
Morrisville, NC 27560
United States of America
P: +1.919.466.1190
F: +1.919.831.7040

Current Local Time

11:28:07 PM

Established in 2002, our Research Triangle Park office was formed to respond to the unique profile and legal needs of businesses located in the largest high technology research and development park in the United States. Home to more than 200 companies, Research Triangle Park’s success reflects its strategic proximity to three world-class research universities located in nearby Durham, Raleigh, and Chapel Hill, North Carolina.

Our Research Triangle Park office features one of the largest health care advisory teams in the Southeast serving a national client base. Our team provides legal and professional consulting services to a wide range of clients, including academic medical centers and research institutions, hospitals and health systems, pharmaceutical companies, long-term care facilities, accountable care organizations, clinically integrated networks, 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. 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 include 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. 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.

Rankings and Awards
  • 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 United States, 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.”
  • In 2018, our national lawyers were recognized by U.S. News-Best Lawyers for their work in Biotechnology Law.

Contact
Health Care Consultant
P +1.919.466.1185
Partner
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Associate
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Partner
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Associate
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Managing Partner, Research Triangle Park Office
P +1.919.466.1181
Associate
P +1.919.314.5630
Associate
P +1.919.466.1112
Of Counsel
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Of Counsel
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Associate
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