Senior Legal Counsel with over 20 years of broad-based experience supporting business operations at medical device, biotech and consumer health and well being companies. Technology/Commercial Transactions: Extensive transactional background, including negotiation and drafting of numerous technology and strategic investment transactions (including patent license, supply and collaborative research agreements as well as milestone-based equity investment agreements), clinical trial and material transfer agreements, cross-license and settlement agreements of high-stakes patent litigation, software licensing, OEM and software distribution agreements, supply contracts, sales/pricing contracts (and other customer contracts) and federal, state and local government contracts.Advertising and Marketing: advertising and marketing, connected products and digital advertising, marketing transactions, and privacy for both consumer products as well as Class II and Class III medical devices and combo devices and biologics; pre-litigation dispute management for competitors as well as consumers. FTC and FDA compliance. Health Care Fraud and Abuse Compliance: Experienced at identifying and addressing health care industry compliance risks, including fraud and abuse/anti-kickback issues, OIG anti-kickback safe harbors and off-label promotion/False Claims Act issues. Experienced at designing and implementing processes to ensure business is in compliance with Advamed and PhRMA Code as well as ACCME guidelines and HIPAA privacy rule requirements. FDA Regulatory Compliance: FDA promotional and labeling matters; experienced at identifying and addressing FDA regulatory and quality system regulation compliance issues, including adverse event reporting. Specialties: Legal Counsel, Corporate Counsel, Compliance, FDA Regulatory, Technology Transactions, Commercial Transactions, Medical Devices, Biotech, Fraud and Abuse/Anti-kickback, Patent Licensing