Jason Johnson

Jason helps clients with the full range of regulatory, transactional, compliance, and intellectual property issues that arise in the research, development, and regulatory approval process, including:

• Drafting, reviewing, negotiating, and interpreting a broad range of strategic business agreements, including collaboration, confidentiality, services, consulting, manufacturing, distribution, clinical trial, and licensing agreements;
• Developing and implementing policies on privacy and data protection requirements, and supporting the acquisition and transfer of data, including data transfer arrangements and data use agreements for research and development activities, such as patient registries and bio-repositories;
• Creating and implementing policies and procedures governing clinical research;
• Advising on commercial, brand, and medical initiatives, ensuring compliance with key health care laws, regulations, and guidance, including reviewing promotional, educational, and training materials related to the company’s products;
• Counseling clients on state and federal fraud and abuse issues, including the False Claims Act, the Stark Law, and the Anti-Kickback Statute; and
• Advising clients on state and federal legal and regulatory issues in mergers and acquisitions and related transactions, including due diligence support.

Jason is well-versed in the most complicated federal and state regulatory challenges that his clients face. Before becoming an attorney, he worked as a bench-top scientist in academic and pharmaceutical settings, as well as a clinical research monitor for a clinical research organization. He has firsthand knowledge of clinical research rules and regulations set forth by the Food and Drug Administration, the National Institutes of Health, and institutional review boards. He employs this knowledge to assist clients with the full range of issues that arise in the research and development process.

Finally, Jason has extensive experience as a patent litigator—he has represented pharmaceutical and biotechnology companies in patent litigations for more than 11 years, giving him a unique cross-functional perspective that he uses to support his client’s business needs.