Counseling clients ranging from biotech startups 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 co-leader of the firm’s life sciences interdisciplinary group and leader of the life sciences transactions practice.
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.
Shire in its agreement with Mirum Pharmaceuticals pursuant to which Mirum has obtained exclusive global rights to develop and market maralixibat, an oral inhibitor of the apical sodium dependent bile acid transporter, and Shire has received undisclosed financial consideration and an equity position in Mirum
Incyte in its agreement with Foundation Medicine for the development, regulatory support and commercialization of companion diagnostics, with an initial focus on CDx development for Incyte’s selective FGFR1/2/3 inhibitor in patients with cholangiocarcinoma
Amarin in its collaboration agreement with Mochida Pharmaceutical for the development and commercialization of drug products based on the omega-3 acid, EPA, to treat patients at risk of cardiovascular disease.
Merck KGaA in its novel risk-sharing collaboratioin agreement with SFJ Pharmaceuticals for development of Merck’s abituzumab as a first-line treatment for metastatic colorectal cancer in combination with Erbitux® and chemotherapy
AstraZeneca in the co-development agreement between its subsidiary, Pearl Therapeutics, and Avillion for the global advancement of Pearl Therapeutics’ PT027, a treatment for asthma
Radius Health in its license and development agreement with Teijin relating to abaloparatide-SC in Japan
Shire in its agreement with Novimmune granting Shire exclusive worldwide rights to develop, manufacture and commercialize novel bispecific antibodies for the treatment of hemophilia A
Takeda in its collaboration agreement with Cardurion Pharma
Shire in its worldwide development and commercialization collaboration with Parion Sciences relating to ENaC inhibitors for dry eye disease and other ophthalmic indications
Merck KGaA in its clinical co-development agreement with Avillion to develop through Phase III Merck’s bi-specific anti IL-17 A/F Nanobody® for plaque psoriasis
Incyte in its global collaboration with Calithera Biosciences to develop and commercialize arginase inhibitors in hematology and oncology, and related equity investment
Incyte in its global strategic collaboration with Merus for the research, discovery, development and commercialization of bispecific antibodies with a focus on immuno-oncology
Teva in connection with its $40.5 billion acquisition of Allergan’s worldwide generic pharmaceutical business
Shire in its license agreement with Pfizer for global rights in all indications for PF-00547659, an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease
Takeda in its collaboration with Ultragenyx to develop and commercialize therapies for rare genetic diseases
Incyte in the acquisition of Ariad’s European operations and in-license of Iclusig® in Europe
Novo Nordisk in licensing and intellectual property matters related to the acquisition of Calibrium LLC and MB2 LLC
Incyte in its license and collaboration agreement with Jiangsu Hengrui Medicine for the development and commercialization of SHR-1210, an investigational anti-PD-1 monoclonal antibody, worldwide except mainland China, Hong Kong, Macau, and Taiwan
GSK in the formation of the Altius Institute for Biomedical Sciences, an independent, non-profit research institute, in Seattle, Washington, to be led by Dr. John A. Stamatoyannopoulos
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
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
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
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
GSK in its co-development and co-commercialization agreement with Janssen Biologics for sirukumab
Eli Lilly in its transfer of US 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 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
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
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.
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
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
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
Schering-Plough in its global collaboration with Novartis to develop and commercialize a once-daily inhaled fixed-dose combination therapy for asthma and COPD
Shire in its up to $500 million collaboration with New River Pharmaceuticals for the development and commercialization of a late-stage ADHD compound
Paul Royalty Fund in its revenue monetization and equity investment in Verus Pharmaceuticals
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
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
Band 1, Corporate/M&A, New Jersey, Chambers USA (2018)
Ranked, Life Sciences: Corporate/Commercial, Nationwide, Chambers USA (2018)
Member, American Bar Association, Business Law Section
Ranked, Chambers USA: America's Leading Lawyers for Business (2006, 2008–2017)
Recommended, Healthcare: Life Sciences, The Legal 500 US (2013–2017)
Recommended in Life Sciences Commercial and Partnering, PLC Which Lawyer? Yearbook 2008
Recommended in Life Sciences Commercial and Partnering by PLCCross-border Life Sciences Handbook (2007/2008)
Recommended, Industry focus: Healthcare: life sciences; Recommended, Intellectual property: Patents: licensing, The Legal 500 US (2018)
Listed, New Jersey Super Lawyers (2005–2009)
Recipient, Philadelphia Business Journal Inaugural Life Sciences Award for Best Consultant (Later Stage) (2010)
Life Sciences Star, Financial and Corporate, LMG Life Sciences (2012–2018)
Listed, Law360 Life Sciences MVP (2014)
Listed, Law360 Healthcare MVP (2012)
Recognized, Life Sciences, Who’s Who Legal (2016, 2018)