David M. McIntosh
David McIntosh is head of Ropes & Gray’s intellectual property transactions practice group. He advises a wide range of companies, investors, and institutions primarily in the life sciences industry in all manner of transactions involving intellectual property, including technology licensing, strategic collaborations, mergers and acquisitions, joint ventures, supply and distribution arrangements, co-promotion agreements, outsourcing transactions, and other strategic commercial agreements.
David’s practice focuses on the life sciences industry, but he also has had extensive experience advising companies and investors in the technology and branded product industries with respect to strategic transactions involving intellectual property as well as day-to-day commercial and corporate matters. David also provides guidance on integrating advice from other legal experts, such as patent specialists, litigators and regulatory advisors, so that it aligns with companies’ corporate strategy and practices.
- Represented biopharmaceutical company Sarepta Therapeutics in a strategic investment and licensing transaction with Lacerta Therapeutics, a gene therapy company, in which Sarepta entered into a license and option agreement for up to three new CNS-targeted gene therapy programs, including exclusive rights to Lacerta’s gene therapy candidate for Pompe Disease and options to two additional candidates, and made an equity investment of $30 million in Lacerta.
- Represented Sarepta Therapeutics in the negotiation of an exclusive license agreement with Lysogene, a gene therapy company targeting the treatment of orphan diseases of the central nervous system, to develop LYS-SAF302, a gene therapy directed towards the treatment of Mucopolysaccharidosis type IIIA (MPS IIIA), a rare and fatal neurodegenerative disorder for which there are currently no treatment options.
- Represented Takeda Pharmaceutical Company Limited in a partnership with Ambys Medicines, a company launched by Takeda and Third Rock Ventures, to discover and develop novel cell and gene therapies for liver disease. Takeda has committed $100 million and retains options to develop and commercialize products in certain geographies, including participation in the Series A financing.
- Represented Arbor Biotechnologies in a strategic research collaboration with Vertex Pharmaceuticals concentrated on the discovery of novel proteins including DNA endonucleases with the goal of furthering the development of new gene-editing therapies for cystic fibrosis and four other diseases to be determined at a later point.
- Represented Sana Biotechnology, Inc. in a licensing agreement with the University of California San Francisco related to the launch of Sana, a new biotechnology company focused on engineering cells to create novel medicines for various diseases.
- Advised a global pharmaceutical company in a research collaboration and option agreement to discover, develop and commercialize integrin compounds for the treatment of kidney disease.
- Advised Blueprint Medicines Corporation in connection with an exclusive collaboration and license agreement with CStone Pharmaceuticals, a China-based clinical stage biopharmaceutical company, concerning the development and commercialization of three investigational cancer therapies in mainland China, Hong Kong, Macau and Taiwan. At the time of its completion, this transaction was the largest investigational cancer therapeutic licensing deal ever done in China.
- Advised The Independent Transactions Committee of the Board of Directors of Akcea Therapeutics in connection with the negotiation of an exclusive, worldwide licensing deal with affiliate Ionis Pharmaceuticals related to the commercialization of two of Ionis’ drugs for the treatment of hereditary transthyretin amyloidosis, a progressive and fatal disease resulting from abnormal protein deposits in the peripheral nervous system. This transaction is potentially worth up to $1.7 billion plus profit sharing payments.
- Advised Shire Plc in a collaboration with Rani Therapeutics to exclusively conduct research on the use of Rani’s Pill(TM) technology for the oral delivery of factor VIII (FVIII) therapy for patents with hemophilia A. As part of the collaboration agreement, Shire was allowed an exclusive licensing option to develop and commercialize the Pill(TM) technology following the completion of feasibility studies.
- Advised Takeda Pharmaceutical Company Limited in a $230 million research, development and commercial collaboration and multi-program option and license agreement with Wave Life Sciences Ltd. focused on central nervous system (CNS) disorders, including Huntington’s and Alzheimer’s diseases, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), and dementia. Depending on the success of licensed programs, Wave may be eligible to receive over $2 billion in cash milestone payments.
- Advised a major pharmaceutical company in a joint venture and strategic collaboration with a venture capital firm to create a NewCo dedicated to the treatment of certain rare liver diseases. In connection with this joint venture, the pharmaceutical company entered into a license and collaboration agreement with NewCo, under which the company will receive four exclusive options to receive exclusive licenses for lead candidates (and their back-ups) developed by NewCo outside of the United States.
- Represented Akebia Therapeutics, Inc. in the $865 million global expansion of its collaboration and license agreement with Otsuka Pharmaceutical Co. to develop and commercialize vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in Phase 3 development, in Europe, China and other territories.
- Represented Akebia Therapeutics, Inc. in its exclusive license agreement with Vifor Pharma Group, pursuant to which Vifor is granted the exclusive right to distribute Akebia’s Phase 3 oral anemia drug vadadustat through its network of U.S. dialysis centers. Vifor is also making a $50 million investment in Akebia at $14 a share.
- Represented Homology Medicines in its research and development collaboration with Novartis to use Homology’s gene editing technology to develop new treatments for select ophthalmic targets and hemoglobin blood disease.
- Represented Juno Therapeutics in connection with its in-license of a small molecule drug candidate from Eli Lilly and Company to be used in combination with Juno’s proprietary cellular immunotherapies for the treatment of cancer as well as its in-license of related patents from Fred Hutchinson Cancer Research Center.
- Represented a clinical-stage biotechnology company in connection with a strategic license and supply arrangement, pursuant to which the client received a patent license and long-term supply arrangement for proprietary technology for use in the manufacture of immunotherapy products intended for the treatment of certain cancers.
- Represented Lantheus Medical Imaging, Inc. in its license and collaboration agreement with GE Healthcare related to the development and worldwide commercialization of flurpiridaz F 18, a positron emission tomography (PET) myocardial perfusion imaging (MPI) agent in phase 3 development for the diagnosis of coronary artery disease (CAD).
- Represented Akebia Therapeutics, Inc. in an exclusive licensing agreement with Janssen Pharmaceutical under which Akebia in-licensed a portfolio of well-characterized HIF pathway compounds with potential applications across multiple therapeutics areas.
- Represented The Broad Institute in connection with various research and license transactions, including its collaboration agreement with Intel Corporation to scale researchers’ ability to analyze massive amounts of genomic data from diverse sources worldwide.
- Represented Akebia Therapeutics, Inc. in its $1 billion collaboration and license agreement with Otsuka Pharmaceutical Co. for the worldwide development and U.S. co-commercialization of vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer currently in phase 3 development for the treatment of anemia associated with chronic kidney disease.
- Represented Takeda Pharmaceuticals in connection with the spin-out of Cerevance, a neuroscience company focused on discovering and developing novel therapeutics for neurological and psychiatric disorders.
- Represented Selecta Biosciences in connection with the license of its synthetic vaccine particles technology to Spark Therapeutics for co-administration with certain gene therapy products, as well as in connection with the negotiation of a number of sponsored research and license agreements.
- Represented Sarepta Therapeutics in connection with an exclusive license and collaboration agreement with Summit Therapeutics pipeline for Duchenne muscular dystrophy, as well as in connection with the negotiation of a number of sponsored research and license agreements with U.S. and international academic institutions.
- Represented Takeda Pharmaceuticals in its collaboration with Roivant Sciences to launch Myovant Sciences Ltd.
- Represented Boehringer Ingelheim in connection with the negotiation of a global collaboration with AbbVie to develop and commercialize a Phase 3 anti-IL-23 monoclonal biologic antibody in development for psoriasis, Crohn's disease, psoriatic arthritis and asthma, as well as an anti-CD-40 antibody in Phase 1 development.
- Represented Genzyme Corporation in connection with the acquisition of Caprelsa®, a rare disease therapy to treat symptomatic or progressive medullary thyroid carcinoma, from AstraZeneca.
- Represented Shire in connection with the negotiation of an amended and restated collaboration and license agreement with Sangamo.
- Represented Takeda in connection with the negotiation of a license and option transaction with Natrogen Therapeutics.
- Represented Becton Dickinson in connection with various acquisitions, dispositions and license and development transactions.
- Represented CANbridge Life Sciences, a Chinese life sciences company, in connection with the negotiation of a license and collaboration agreement with AVEO Pharmaceuticals.
- Represented Genzyme Corporation in connection with a collaboration agreement and $700 million equity investment in Alnylam Pharmaceuticals, Inc. related to rare disease siRNA drug candidates.
- Represented Synageva BioPharma in connection with various licensing transactions, including transactions with Shire and the University of Georgia.
- Represented Proteostasis Therapeutics in connection with licensing transactions, including a collaboration agreement with Astellas Pharmaceuticals to research and develop therapeutic candidates that modulate the Unfolded Protein Response (UPR).
- Represented Wright Medical in connection with its sale of its knee replacement business to MicroPort Scientific Corporation and its settlement and patent license agreement with ConforMIS, Inc.
- Represented Genzyme Corporation in connection with a disposition of Genzyme’s genetics testing and diagnostics business units to Laboratory Corporation of America and Sekisui Chemical Co., Ltd, respectively.
- Represented Genzyme Corporation in a license and acquisition agreement under which Genzyme acquired from Bayer Schering Pharma AG two oncology drugs (Fludara® and Leukine®) then being marketed worldwide as well as worldwide distribution rights with respect to Lemtrada®, then in clinical development for the treatment of MS.
- Represented Genzyme Corporation in a license and collaboration agreement under which Genzyme acquired rights with respect to the development and commercialization of the drug Kynamro® from Isis Pharmaceuticals, Inc.
- Represented Skillsoft Corporation in connection with various commercial, intellectual property, and privacy-related matters.
- Advised NXP Semiconductor with respect to a settlement and patent cross license agreement with Broadcom.
- Represented Pfizer in connection with the outsourcing of its post-proof of concept clinical trial management function to Parexel International, Inc. and Icon Clinical Research Limited as well as other IT, licensing and privacy-related matters.
- Advised TSG Consumer Partners, Kohlberg & Co LLC, Berkshire Partners, Audax Group, TPG Capital, L.P., Gridiron Capital, General Catalyst Partners, LLC, Bain Capital LLC and other private equity firms with respect to intellectual property matters in connection with their investments in the consumer product, technology, life sciences and industrial sectors.
- Co-author, “Federal Circuit Reaffirms Its Longstanding Patent Exhaustion Rules,” IP Litigator (May-June 2016)
- Quoted, “GCs Name Best Of The Best Attorneys,” Law360 (February 10, 2015)
- Co-author, “Meso Scale V. Roche Rethinks Reverse Triangular Mergers,” Law360 (March 21, 2013)
- Moderator, “So, You’re About to be Acquired: Survival Tips for Biopharma Business Development/Financial Professions” Massachusetts Biotechnology Council (July 26, 2018)