Kevin assists clients with creating and building businesses with the goal of bringing advanced technologies to market. His clients successfully market high technology products throughout the world.
He consults on developing and implementing technology commercialization plans, as well as intellectual property life-cycle strategies. He is also often asked to consult on negotiations related to technology licenses, company formation, corporate transactions, investment funding, regulatory compliance, and product marketing transactions. Kevin's experience with drafting and negotiating agreements includes CRADAs, collaboration agreements, IIAs, MTAs, CDAs, and DUAs as well as more general agreements related to purchases, sales, loans, leases, real estate, employment, insurance, mergers, acquisitions and related agreements.
From a regulatory perspective, his work involves freedom-to-operate, competitive intelligence, market exclusivity, and data exclusivity issues. He has experience with IND/510K/PMA, Hatch-Waxman (NDA/ANDA), OTC, combination products, FDA safe harbor, Patent Term Extension, Orange Book listings, and exploiting scientific data evolving from clinical trials, among other complex issues.
His involvement with investment and grant funding has included performing IP due diligence in seed, angel, and venture capital investments, international mergers/acquisitions, and initial public offerings (S-1 and IPO) for biotechnology and pharmaceutical (branded/generic) companies.
Kevin Buckley is an experienced legal advisor to Fortune 500® and other entrepreneurial biotechnology, pharmaceutical, medical device, and digital health companies. His experience includes complex intellectual property, transactional, and regulatory counseling; patent preparation and prosecution; corporate transactions; licensing; due diligence; opinion drafting; and IP infringement litigation. He has also assisted clients with private investments totaling nearly $100 Million and has represented clients in transactions totaling over $1 Billion.
Prior to founding Torrey Pines Consulting, Kevin was partner in a large US law firm, and also an attorney for the international law firm now known as Dentons -- one of the largest law firms in the world. In addition, he was chief legal counsel to the Research Foundation of a major university. For many years, he was recognized nationally for his biotechnology law practice by The Best Lawyers in America®.
Before becoming a lawyer, Kevin was a biochemist in both academics and industry. He grew up just down the street from the University of California, San Diego where he eventually became an undergraduate Research Scholar and received a B.S. in Biochemistry/Chemistry with a minor degree in Economics. While a Research Associate in the laboratory of Dr. Dennis Carson, founder of the UC San Diego Moores Cancer Center, he investigated the role of novel purine nucleoside analogs in autoimmune diseases and cytokine mediated cell responses including apoptosis, rheumatoid arthritis, AIDS and cancers. He then pursued his interests in the biotech industry where he investigated ribonucleic acid (RNA)-based therapeutics for treating viral infections.
Kevin received a Juris Doctorate from the University of Pittsburgh where he was Editor-in-Chief of the Pittsburgh Journal of Technology Law and Policy. He has also been an academic advisor to entrepreneurship centers at the University of Pennsylvania and Washington University in St. Louis. Recently, he was an adjunct professor at Washington University School of Law where he taught a Biotechnology Law intersession course.
Innovations he has worked with include small molecule pharmaceuticals and biopharmaceuticals (e.g., central and peripheral pain therapeutics, formulations, and delivery; enzyme mimetics; therapeutic polypeptides and polynucleotides including vaccines, monoclonal antibodies, antibody fragments, siRNA, shRNA, miRNA, ribozymes, antisense DNA, and enzymes); medical devices (e.g., stents, heart valves, catheter systems, magnetic nanoparticle delivery and hydrodynamic systems, fully implantable stimulators, and in vitro diagnostics); "wearable" monitors and sensors; prosthetics; structural proteomics; three-dimensional molecular modeling and drug design; stem cells (somatic and iPSCs), cardiovascular therapy, and therapeutic cloning methods; transgenic plants and animals; and cell culture equipment and methods.