Karen Spindler is a corporate partner in the San Francisco office of Gibson, Dunn & Crutcher where her practice focuses on advising life sciences companies and investors on a variety of intellectual property transactions. Ms. Spindler represents the full spectrum of companies in the life sciences sector, including companies operating in the areas of pharmaceuticals, biologics, diagnostics and medical devices.
Ms. Spindler has considerable experience structuring complex strategic collaboration and partnering transactions, including co-development, co-commercialization and joint venture arrangements, and advising on manufacturing and supply agreements, services arrangements and academic licenses.
In addition, Ms. Spindler regularly counsels investors and operating companies on complex IP issues arising in the context of corporate transactions (including mergers, product acquisitions, product spin-outs and other structured M&A transactions), and financial investors and company sellers in royalty monetizations.
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Strategic Collaborations, M&A and Royalty Monetizations*
- Sage Therapeutics in (i) its collaboration with Biogen for zuranolone (SAGE-217) and SAGE-324 in psychiatric and neurological disorders, valued in excess of $1.525 billion, and (ii) its collaboration with Shionogi to accelerate development of SAGE-217 in key Asian markets for major depressive disorder and other indications, valued at in excess of $575 million
- Selecta Biosciences in (i) a strategic global agreement with Swedish Orphan Biovitrum AB for SEL-212 for the treatment of chronic refractory gout, with a $100 million upfront and potential milestone and royalty payments in excess of $630 million, and (ii) an option & license agreement with Sarepta Therapeutics to develop and commercialize Selecta’s ImmTOR™ platform with gene therapy candidates for Duchenne muscular dystrophy and certain limb-girdle muscular dystrophies
- Arrowhead Pharmaceuticals in its global collaboration with Takeda to develop ARO-AAT investigational RNA interference therapy to treat alpha-1 antitrypsin-associated liver disease, with a $300 million upfront and potential milestone and royalty payments in excess of $740 million
- Roivant Sciences in its strategic collaboration with Affimed to in-license AFM32 and access Affimed’s Redirected Optimized Cell Killing (ROCK®) platform to develop and commercialize novel ICE® molecules for oncology uses, with Affimed receiving $60 million upfront and potential milestone and royalty payments in excess of $2 billion
- Arvelle Therapeutics in its licensing agreement with SK Biopharmaceuticals obtaining exclusive rights to develop and commercialize Cenobamate® in Europe valued up to $530 million
- Arvinas in agreements with Bayer to jointly launch a company to leverage Arvinas’ PROTAC® technology for agricultural applications and to leverage Arvinas’ novel PROTAC® protein degrader technology to develop human therapeutics in certain indications, for a value of over $110 million in cash and committed funding for the human disease collaboration, the agricultural JV, and an equity investment in Arvinas
- Corbus Pharmaceuticals in its strategic collaboration with Kaken Pharmaceutical granting exclusive rights to commercialize Lenabasum® in Japan for systemic sclerosis and dermatomyositis valued up to $200 million
- Ambys Medicines in its global strategic partnership with Takeda Pharmaceutical under which Takeda commits $100 million to pioneer development of first in class liver therapies, including participation in Ambys’ Series A financing
- Ginkgo Bioworks in (i) its joint venture with Bayer to create Joyn Bio, focused on plant microbiome, with an initial investment of $100 million, (ii) its alliance with Genomatica for bio-based production of intermediate chemicals, (iii) its collaboration with Glycosyn to optimize and scale production of human milk oligosaccharides (hMOS), (iv) its spin-off Motif Ingredients to develop proteins to serve as meat and dairy replacements, and (v) its collaboration with Synlogic to accelerate its pipeline of Synthetic Biotic medicines using Ginkgo’s cell programming platform providing an $80 million equity investment in Synlogic and a $30 million payment to Ginkgo for research and development
- Royalty Pharma in its purchases of royalties in transactions valued at more than $10 billion, including (i) its $3.3 billion purchase of Ivacaftor® royalty rights from the Cystic Fibrosis Foundation, (ii) synthetic royalty financings totaling more than $2 billion with BioHaven, Immunomedics, Sanofi and other confidential counterparties, (iii) its $827 million acquisition of the worldwide royalties to Promacta® (eltrombopag) from Ligand Pharmaceuticals, (iv) its $320 million acquisition of the EU, UK and Swiss royalties for Crysvita® (burosumab) from Ultragenyx, and (v) its up to $270 million upfront, equity and loan arrangement with Epizyme and $330 million agreement with Eisai, for the worldwide royalties to tazemetostat
- Assertio Therapeutics in a stock-for-stock merger to acquire Zyla Life Sciences
- SentreHeart in its sale to AtriCure for up a $300 million in upfront and earnout payments
- Ocera Therapeutics in its sale to Mallinckrodt in a cash tender offer, plus contingent value right
- Teva Pharmaceutical Industries in its $3.2 billion acquisition of Auspex Pharmaceuticals
- Other biotech clients on strategic licensing transactions involving early stage products
- Other biotech clients on licensing foundational IP assets from universities and other academic entities
*Includes matters prior to joining Gibson Dunn.
- Recognized by Best Lawyers in America® 2022 in Biotechnology and Life Sciences
- “Life Sciences Star” by Euromoney Legal Media Group for licensing and collaboration expertise in the life sciences industry (every year since 2012)
- One of the world’s leading 1000 patent practitioners by Intellectual Asset Management (IAM) (every year since 2012)
Before joining the firm, Ms. Spindler was a partner at Goodwin Proctor for several years in its San Francisco office. Prior, she was a partner at Kirkland & Ellis in its San Francisco and Palo Alto offices.
Ms. Spindler received her law degree, magna cum laude, from Santa Clara University School of Law, where she was a member of the Order of the Coif and Senior Production editor of the Computer & High Technology Law Journal. She received her B.S. in biology with honors from Stanford University.