Counseling clients ranging from biotech start-ups to multinational pharmaceutical companies, Randall B. Sunberg structures and negotiates complex collaborations, mergers and acquisitions, divestitures, joint ventures, and corporate partnering and licensing transactions, as well as equity investments and royalty monetization transactions. In addition to pharma, biotech, medical device, diagnostics, and technology companies, Randy advises private equity, venture capital, and investment banking firms. He is vice chair of the firm’s Life Sciences Interdisciplinary group, co-chair of the Life Sciences Transactions Practice, and Managing Partner of the Princeton office.
Randy counsels on alternative financing arrangements such as royalty monetizations. He also handles technical contractual arrangements for drug discovery, development, manufacturing and supply, marketing and co-promotion, and outsourcing in the life sciences industry.
Additionally, he advises boards of directors and significant shareholders on disclosure issues, corporate communications policies, and fiduciary duty matters. He serves clients throughout Europe and Asia, and across the United States.
Because of his global life sciences work, Randy is often asked to speak at industry events worldwide. He has spoken on such topics as mergers and acquisitions, strategic alliances, and licensing and collaboration transactions in the United States at Allicense, BIO and LES annual meetings; in Canada at BIOMedex; and in China at BIOForum; as well as at other life sciences–related conferences. He has also been a guest lecturer at the Rutgers Business School MBA Biotechnology Commercialization Concentration.
Brickell Biotech in its license, development and commercialization agreement with Kaken Pharmaceutical for the development and commercialization of Brickell Biotech’s BBI-4000, a novel dermatological drug for hyperhidrosis, in Japan and certain other Asian countries.
Amarin in its development and commercialization collaboration with Eddingpharm for Vascepa® in China, Hong Kong, Macao and Taiwan.
Ono Pharmaceuticals in its exclusive license agreement with Gilead Sciences for the global development and commercialization of Ono’s oral BTK inhibitor for the treatment of B-cell malignancies and other diseases as a monotherapy and in combination with kinase inhibitors in Gilead’s portfolio, and under which Ono will retain Asian rights.
Merck KGaA in its $850 million up-front and up to $2 billion in milestone payments agreement to co-develop and co-commercialize its anti-PD-L1 antibody with Pfizer as a potential treatment for multiple tumor types
Emergent BioSolutions in its collaboration with MorphoSys to co-develop and commercialize ES414, a bi-specific antibody, for prostate cancer
Brickell Biotech in a license agreement with Merz Pharmaceuticals to develop and commercialize a novel retinoid compound for the treatment of skin conditions
Shire in its expanded R&D collaboration with arGEN-X for antibody discovery against targets focused on rare diseases
Merck in its $14.2 billion agreement to sell its consumer care business to Bayer
Eli Lilly in its license agreement with Sanofi for the potential Rx-to-OTC switch of Cialis®
Amarin in its co-promotion agreement with Kowa Pharmaceuticals for Amarin’s flagship product, Vascepa®, in the United States
CoLucid Pharmaceuticals in its collaboration with IlDong Pharmaceutical relating to the development and commercialization of Lasmiditan in South Korea and southeast Asia
Lundbeck in its up to €100 million collaboration (plus royalties) with Otsuka Pharmaceutical to develop and commercialize nalmefene (a unique dual-acting opioid system modulator, and sold under the brand name Selincro in Europe) in Japan for the reduction of alcohol consumption in adult patients with alcohol dependence.
Eli Lilly in its negotiation of a co-development and co-commercialization agreement with Pfizer relating to tanezumab and other hNGF antibodies for the treatment of pain
Enzon Pharmaceuticals in the asset sale of its PEGylation Linker Technology platform and related assets to Belrose Pharma
Lundbeck in its up to $825 million collaboration with Otsuka Pharmaceutical to develop an experimental Alzheimer's treatment
NPS Pharmaceuticals in its termination and transition services agreement with Takeda to re-acquire certain rights to develop and sell Revestive and Preotact
Takeda in its collaboration with Resolve Therapeutics to develop compounds for the treatment of lupus (also known as Systemic Lupus Erythematosus, or SLE) and other autoimmune diseases
Lundbeck in its agreement with Otsuka Pharmaceutical to promote the drug Abilify in 14 European countries
Merck Serono in its option and license agreement valued up to $225 million with Opexa Therapeutics for the development and commercialization of TcelnaTM, a T-cell therapy for those suffering from multiple sclerosis
GSK in its up to $335 million research collaboration and license agreement with MD Anderson Cancer Center through its new Institute for Applied Cancer Science (IACS) to develop new therapeutic antibodies that promote an immune system attack against cancer
Merck Serono in its development, manufacturing and commercialization collaboration with Dr. Reddy's Laboratories for a portfolio of biosimilar compounds in oncology primarily focused on monoclonal antibodies
Enzon Pharmaceuticals in its research, development, and licensing collaboration with Zhejiang Hisun Pharmaceuticals focused on therapeutics using Enzon's PEGylation linker technology, and Hisun's acquisition of development and commercialization rights in China to PEG-SN38, a PEGylated anti-cancer drug
Auxilium Pharmaceuticals in its collaboration with Actelion for the development and commercialization of Xiaflex® in Canada, Mexico, Brazil, and Australia
Concordia Pharmaceuticals in its asset sale transaction with Kadmon including rights to salirasib, a Phase 2, novel, orally available, small molecule therapeutic in development for the treatment of solid tumors
Shire in its co-development and co-commercialization agreement with Shionogi for certain of Shire's ADHD medicines in Japan
GSK in its co-development and co-commercialization agreement with Janssen Biologics for sirukumab
Lundbeck in its up to $1.8 billion co-development and co-commercialization global alliance with Otsuka Pharmaceutical for up to five innovative psychiatric and neuroscience products worldwide
Eli Lilly in its transfer of U.S. rights to sepsis drug Xigris® to BioCritica, a newly created biotech company jointly owned by Lilly, Care Capital, and NovaQuest Capital
ViroPharma in its global collaboration and licensing agreement for the subcutaneous combination of Cinryze® (C1 esterase inhibitor [human]) with Halozyme Therapeutics' recombinant human hyaluronidase enzyme (rHuPH20) EnhanzeTM technology
Takeda in its up to $750 million development and commercialization collaboration with Intra-Cellular Therapies on selective PDE1 inhibitors for cognitive impairment associated with schizophrenia
Lundbeck in its donation together with Novartis of their rights to compound Lu AE58479 for SSADH deficiency to the National Institutes of Health
Auxilium Pharmaceuticals in its up to $262 million development, commercialization, and supply collaboration with Asahi Kasei for Xiaflex® in Japan
Lundbeck in its drug discovery collaborations with Zenobia Therapeutics and Vernalis plc for inhibitors for LRRK2
Invida Group in its exclusive licensing and distribution collaboration with Orexo AB covering the Pacific region for Abstral™
Lundbeck in its development and commercialization collaboration agreement with Kyowa Hakko Kirin relating to adenosine A2A antagonist products outside of Japan and the Asia region for all fields, including Parkinson's disease
Onyx Pharmaceuticals in its more than $300 million development and commercialization collaboration with Ono Pharmaceutical for Carfilzomib and ONX-0912 in oncology indications in Japan
Concordia Pharmaceuticals in its licensing agreement with Ono Pharmaceutical to develop and commercialize salirasib, an agent for the treatment of pancreatic, non-small cell lung and colorectal cancers, in Japan
Diamyd Medical AB in its up to $625 million license, development, and commercialization agreement with Ortho-McNeil-Janssen Pharmaceuticals focused on GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions
GlaxoSmithKline in its up to $1.58 billion antisense drug collaboration with Isis Pharmaceuticals for the development and commercialization of therapeutics for rare and infectious diseases
Biovail in its acquisition of certain AMPAKINE® compounds and associated intellectual property from Cortex Pharmaceuticals
Smiths Detection in its collaboration with Novartis Diagnostics relating to Smiths' Bio-Seeq platform and LATE-PCR technology for use in a range of point-of-care diagnostic tests
NPS Pharmaceuticals in the sale of its royalty rights from sales in Asia of REGPARA to a fund managed by DRI Capital for $38.4 million
Auxilium Pharmaceuticals in its up to $485 million development, commercialization, and supply collaboration with Pfizer for Xiaflex® in Europe and Eurasia.
Profectus BioSciences in the worldwide transfer of Wyeth's therapeutic and prophylactic DNA and vectored vaccine programs for HIV, including NIH contracts providing multimillion dollar funding, as well as HCV, HPV, HSV, and Malaria.
Immunomedics in its up to $620 million development and commercialization collaboration with Nycomed for the subcutaneous formulation of its humanized anti-CD20 antibody in non-cancer
Takeda in its $100 million up-front and up to $1 billion development and commercialization collaboration and technology transfer transaction with Alnylam relating to RNAi therapeutics
Lundbeck in its $100 million up-front and up to $250 million in connection with regulatory approvals, development and commercialization collaboration with Myriad for the Alzheimer's disease drug Flurizan
Shire in its up to $325 million development and commercialization collaboration with Alba Therapeutics for gastrointestinal permeability inhibitor AT-1001
Adolor in its up to $265 million development and commercialization collaboration with Pfizer for delta opioid agonists
Acura Pharmaceuticals in its development and commercialization collaboration with King Pharmaceuticals for opioid analgesic products
Shire in its up to $440 million genetic disorders development and commercialization collaboration with Amicus Therapeutics
NPS Pharmaceuticals in its licensing collaboration with Nycomed for Gattex
Cardiokine in its up to $220 million development and commercialization collaboration with Biogen Idec for lixivaptan, a selective V2 vasopressin receptor agonist
Shire in its up to $825 million development and commercialization collaboration with Renovo for Juvista (human TGFß3)
Merck in its divestiture of several marketed products to Iroko Pharmaceuticals
Lundbeck in its acquisition of Saegis Pharmaceuticals
Ambrilia Biopharma in its up to $232 million worldwide licensing agreement with Merck relating to its HIV/AIDS protease inhibitor program
Cytogen in the sale of its 50% joint venture interest in the conjugated antibody development and commercialization collaboration, PSMA Development Company LLC, to Progenics
Schering-Plough in its global collaboration with Novartis to develop and commercialize a once-daily inhaled fixed-dose combination therapy for asthma and COPD
Pharmasset in its development and commercialization collaboration with Bukwang Pharmaceuticals of Korea for the treatment of chronic hepatitis B virus
BiovailPharmaceuticals in its more than $100 million product divestiture, strategic collaboration and research and development alliance with Kos Pharmaceuticals in the area of cardiovascular disease
Shire in its up to $500 million collaboration with New River Pharmaceuticals for the development and commercialization of a late-stage ADHD compound
Schering-Plough in its acquisition of Bayer AG's primary care pharmaceutical product business in the United States and related strategic alliances on oncology products and on Zetia® in Japan
Paul Royalty Fund in its revenue monetization and equity investment in Verus Pharmaceuticals
Sanofi-Aventis in the restructuring of its Actonel® collaboration with Procter & Gamble
Sanofi-Aventis in its up to $115 million royalty monetization transaction with Paul Royalty Fund relating to sales of Lunesta® by Sepracor
Pharmasset in its $300 million collaboration with Roche to develop and commercialize nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus infections
Sanofi-Aventis in its up to $485 million collaboration with Regeneron to develop and commercialize VEGF-Trap products, and related equity investment
Quintiles in its co-development and co-promotion collaboration with Eli Lilly for Cymbalta®
Cephalon in its $444 million stock-for-stock acquisition of Anesta
Sanofi-Aventis in its collaboration with ImmunoGen to discover, develop and commercialize novel antibody-based oncology products
Adolor in its worldwide development and commercialization collaboration for Entereg® with GlaxoSmithKline
Arena Pharmaceuticals in its drug discovery collaboration with Merck
Sanofi-Aventis in its inhaled insulin strategic alliance with Pfizer and related collaboration and licensing arrangements with Nektar Therapeutics
New York University School of Law, 1982, J.D.
Yale University, 1977, B.A.
Awards and Affiliations
Member, American Bar Association, Business Law Section
Listed as Recommended in Life Sciences Commercial and Partnering by PLC Cross-border Life Sciences Handbook (2007/2008)
Listed, Chambers USA: America's Leading Lawyers for Business (2006, 2008–2014)
Listed, Elite Leading Lawyers List for Healthcare: Life Sciences, Legal 500 United States (2013–2014)
Listed as Recommended in Life Sciences Commercial and Partnering, PLC Which Lawyer? Yearbook 2008
Listed, New Jersey Super Lawyers (2005–2009)
Recipient, Philadelphia Business Journal Inaugural Life Sciences Award for Best Consultant (Later Stage) (2010)
Listed, Legal Media Group's Life Sciences "Life Sciences Star" – Transactional (2012–2014)