With an office based in Somerset County, New Jersey, the center of one of the nation’s largest concentrations of pharmaceutical companies, the attorneys in the Health Care & Life Sciences Law Practice Group have decades of experience working with pharmaceutical companies, pharma service providers and medical device companies at varying stages of growth – from start-ups to emerging life science companies to the world’s largest and most recognized pharmaceutical companies.
Our clients include drug and medical device developers, manufacturers and distributors as well as companies that service the pharmaceutical industry. Pharma companies and Pharma service providers operate in a highly-competitive and heavily-regulated industry often facing unique challenges. Understanding and navigating the morass of state and federal laws and regulations, the critical import of healthcare compliance, the protection of personal health information and the impact these issues have on small and large companies, are all critical to understanding and overcoming of these challenges.
Our years of experience representing pharma companies, pharma service providers and medical device companies in connection with a wide range of legal needs have given us an understanding of these issues from unique and different perspectives.
The services provided by NM to the pharma, pharma services and medical device industries include:
- General contract preparation including service, master service, project, sales, distribution and licensing agreements
- Regulatory and compliance guidance including assistance with complying with federal laws, rules and regulations such as FDA, the Sunshine Act, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Health Care Professionals, the Federal Food, Drug and Cosmetic Act, the Medicare/Medicaid Anti-Kickback Statute, the Prescription Drug Marketing Act, the Health Insurance Portability and Accountability Act and similar state laws, rules and regulations
- Representation in mergers, acquisitions, reorganizations and divestitures
- Structuring of joint ventures, collaboration relationships and similar strategic alliances
- Work with contract sales organizations that provide sale teams, detailing services, sales force recruitment and training
- Assist companies to respond efficiently and effectively to subpoenas from the Federal government and third parties
- Representation of pharma service providers in matters related to Clinical Nurse Educator and Medical Science Liaison teams, sample accountability; warehousing and fulfillment, market research and data analytics
- Prepare and review clinical trial agreements (for sponsors, investigators and monitors)
- Prepare software license agreements
- Negotiate with pharmacy benefit managers, data providers, and electronic record providers to assist with commercialization and product reimbursement
- Patent, trademark and copyright counseling; patent and trademark clearance, opinions, filing, maintenance, prosecution; worldwide IP portfolio management; oppositions and enforcement; licensing negotiations and drafting in the pharmaceutical and healthcare industries
- Defense of products liability claims
- Labor and human resources guidance and employment counsel services