
Life Sciences
Extensive representation of multinational pharmaceutical companies, world-class universities, and dynamic, emerging growth companies has given the multidisciplinary Wiggin and Dana Life Sciences Practice Group robust capabilities and a deep understanding of the unique business objectives and concerns of our clients in the biotechnology, pharmaceutical, and medical device industries. That breadth and depth of experience means greater flexibility, responsiveness, and ability to anticipate your needs.
For more than 30 years, Wiggin and Danaโs lawyers have served a diverse group of life sciences clients, including the worldโs largest health care companies, midsize public and private biotechnology companies, university spinoffs, individual scientists, and entrepreneursโin their most vital matters, including
- Mergers and acquisitions
- Strategic partnerships
- Other collaborative research, development, and licensing arrangements
- Distribution, co-promotion, and marketing agreements
- Investigator-sponsored and industry-sponsored research arrangements
- Manufacturing and distribution agreements
- Clinical trial operations and execution
- Intellectual property matters
- Academic technology transfer
- Privacy and data protection
- Other health and medical industry matters
- Corporate finance (public and private)
- PIPE (Private Investment in Public Equity) financings
- Litigation and dispute resolution
- Export control and sanctions
- Real estate, construction, and facilities matters
- Special issues facing scientists and universities
- Human resource issues
Our clients come from across the United States and around the world. As a life sciences law firm our attorneys have practical experience in the life sciences industries, hold advanced degrees in scientific and technical fields, regularly author articles in industry-related publications, and frequently present before industry-related groups.
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Wiggin and Dana regularly represents biotechnology, pharmaceutical, and medical device clients on matters critical to their industry, including
- Collaborative and strategic alliances. Counseling clients in a variety of collaborative research, development, licensing, and marketing arrangements in diverse medical areas, including
- Oncology
- Metabolic disorders
- Viral diseases
- Cardiovascular disorders
- Neuroscience
- Immunology
- Dermatology
- Orphan drugs
- University licensing, sponsored research, grants, and consulting arrangements, addressing such issues as the ownership of inventions, royalties, support for research, and equity participation by universities. We regularly counsel clients with respect to university and research institution arrangements worldwide.
- Mergers, acquisitions, and divestments of businesses, facilities, and product rights, both domestic and cross-border.
- Financings. Public offerings, venture capital financings, and corporate partner equity investments for our international pharmaceutical and biotechnology clients, including
- Biotechnology and life sciences companies seeking venture capital, seed, or angel financing
- Pharmaceutical companies, venture capital funds, and angels providing strategic financing
- Founders
- Strategic investors
- Intellectual property matters, including worldwide prosecution and litigation of patents, trade secrets, trademarks, domain names, copyrights, and other intellectual property rights. Several of our patent attorneys have practical knowledge in scientific disciplines relevant to the life sciences.
- Health care issues, in areas such as data privacy and protection, bioinformatics, telemedicine, rights in medical data and research protocols, and consent issues.
- Human resources, with significant experience advising our biotechnology and life science clients on immigration, protection of proprietary information, safety and environmental concerns, compensation, stock options plans, and other benefits.
- Products liability litigation and dispute resolution, including assisting our clients in resolving intellectual property, contract, and other commercial disputes with commercial partners, competitors, and others. Our combined patent practice and litigation experience allows us to assist clients in the enforcement and defense of patent infringement proceedings relating to important business and technical assets.
- Real estate, construction, and facilities, assisting large multinational pharmaceutical companies as well as startup biotechnology companies in the leasing, acquisition, construction, financing and development of essential research and manufacturing facilities.
Experience
Wiggin and Dana counsels diverse clients with their collaborative research, discovery, development, licensing, manufacturing and marketing arrangements for products and technologies targeting a broad range of therapeutic and diagnostic areas. Wiggin and Dana also represents life sciences clients on mergers, acquisitions, and divestments of businesses, facilities, and product rights, both domestic and cross-border. Our strong and long-standing record of successfully negotiated agreements with biotechnology, pharmaceutical, medical device and diagnostics industry leaders has received national and international recognition.
Listed below are representative samples of corporate partnering transactions and mergers and acquisitions in which Wiggin and Dana has acted as counsel. Each transaction is described according to its status upon completion of the transaction.
For a list of Representative Corporate Partneringย Transactions, please seeย below or click here to view a PDF.
For a list of Representative Mergers and Acquisitions, please see below orย click here to view a PDF.
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Highlighted Recent Life Sciences Corporate Partnering and Merger and Acquisition Transactionsย
- Represented its client Affibody AB (โAffibodyโ) in its collaboration and license agreement with Chiesi Farmaceutici S.p.A (โChiesi Groupโ) to discover, develop and commercialize innovative treatments for respiratory diseases based on Affibodyยฎ molecules against undisclosed targets for respiratory diseases. Under the terms of the agreement, Affibody is eligible to receive upfront, development, regulatory, and commercial milestone payments up to USD 214 million plus royalties on sales for the first program. Additionally, the agreement may be expanded to a total of three programs, in which case Affibody is eligible to receive upfront, development, regulatory, and commercial milestone payments up to USD 637 million plus royalties on sales. Affibody retained the option to co-promote in the Nordic region.
- Represented Xspray Pharma AB in its Commercialization Agreement with EVERSANA Life Science Services, LLC for the launch and commercialization of Xsprayโs innovative cancer therapy, Dasynoc, for the treatment of chronic myeloid leukemia and acute lymphatic leukemia.
- Represented Pathos AI, Inc. (Pathos) in its license from Forma Therapeutics, Inc., a subsidiary of Novo Nordisk, of all rights, title and interest in Formaโs CBP/p300 inhibitor known as FT-7051 for the treatment of metastatic castration-resistant prostate cancer and other diseases.
- Represented BioInvent International AB in its exclusive option and license agreement with Exelixis, Inc. to develop novel antibody-based immuno-oncology therapies. The collaboration is intended to expand Exelixisโ portfolio of antibody-based therapies and will combine BioInventโs antibody and cancer immunology expertise with Exelixisโ expertise and resources in antibody engineering and antibody-drug conjugate (ADC) technologies.ย ย See additional details below under โDiscovery Technologiesโ.
- Represented Rallybio Corporation in its acquisition of worldwide exclusive rights to Sanofiโs KY1066 (RLYB331 going forward), a preclinical potentially first-in-class antibody. RLYB331 has the potential to address a significant unmet need for patients with severe anemia with ineffective erythropoiesis and iron overload, such as beta thalassemia (BT) and a subset of myelodysplastic syndromes (MDS), amongst others. See additional details below under Products in Development and Approved Products.
Discovery Technologies
- Represented its client Affibody AB (โAffibodyโ) in its collaboration and license agreement with Chiesi Farmaceutici S.p.A (โChiesi Groupโ) to discover, develop and commercialize innovative treatments for respiratory diseases based on Affibodyยฎ molecules against undisclosed targets for respiratory diseases. Under the terms of the agreement, Affibody is eligible to receive upfront, development, regulatory, and commercial milestone payments up to USD 214 million plus royalties on sales for the first program. Additionally, the agreement may be expanded to a total of three programs, in which case Affibody is eligible to receive upfront, development, regulatory, and commercial milestone payments up to USD 637 million plus royalties on sales. Affibody retained the option to co-promote in the Nordic region.
- Representedย Alligator Bioscience ABย in expansion of its research collaboration and license agreement withย Orion Corporation. Following success of the research conducted under the initial agreement signed in 2021, for which Wiggin and Dana also acted as counsel to Alligator, the expanded relationship includes development of a second bispecific antibody using Alligators proprietary RUBYโข platform and includes an additional upfront payment as well as success fees in addition to the milestones and royalties set forth in the initial agreement.
- Represented Rallybio IPF, LLC (Rallybio), a subsidiary of Rallybio Corporation, a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare disorders, in its Research and Development Collaboration Agreement with AbCellera Biologics Inc. (AbCellera) to discover, develop and commercialize antibody-based therapeutics for rare diseases using AbCelleraโs antibody discovery platform to identify product candidates. Under the terms of the agreement, AbCellera and Rallybio will co-develop up to five rare disease therapeutic targets, which will be chosen together by both companies. The collaboration will allow Rallybio to add product candidates to its existing pipeline and also provides the option for AbCellera to conduct process development and clinical manufacturing activities. The partnershipโs first program will focus on addressing the significant unmet therapeutic needs of patients with rare metabolic diseases.
- Represented BioInvent International AB in its exclusive option and license agreement with Exelixis, Inc. to develop novel antibody-based immuno-oncology therapies. The collaboration is intended to expand Exelixisโ portfolio of antibody-based therapies and will combine BioInventโs antibody and cancer immunology expertise with Exelixisโ expertise and resources in antibody engineering and antibody-drug conjugate (ADC) technologies.ย ย BioInvent will be responsible for target and antibody discovery and characterization activities using BioInventโs proprietary n-CoDeRยฎ antibody library and F.I.R.S.Tโข screening platform, which rapidly screens samples from patients with cancer to identify antibodies and targets with promising therapeutic potential. Exelixis will pay BioInvent an upfront fee of $25 million in exchange for rights to select three targets.ย Once Exelixis exercises its option, it will pay BioInvent an option exercise fee and will assume responsibility for all future development and commercialization activities for the associated candidates, including potential ADC and bispecific antibody engineering activities.ย Additionally, BioInvent will be eligible for success-based development and commercialization milestones, as well as tiered royalties on the net sales of any products that are successfully commercialized.
- Represented Revelar Biotherapeutics in its launch as an independently-operated company and its exclusive license from Twist Bioscience to develop a lead antibody to treat SARS-CoV-2 (the coronavirus that causes COVID-19), with the ability to license additional antibodies up to five targets. Twist Bioscience is entitled to milestone payments of more than $100M and eligible for mid-single-digit royalty payments on net product sales in the future. Twist agreed to invest up to $10M of seed funding in Revelar, depending on the advancement of the lead antibody and the licensing of other antibody therapies and also obtained substantial minority ownership in Revelar in return for the antibody, backup compounds and funding.
- Represented Rallybio, LLCย in its collaboration with artificial intelligence (AI) drug discovery companyย Exscientiaย to form a joint venture โ called RE Ventures โ that will use AI to accelerate discovery of small molecule drug candidates for undisclosed rare disease indications.
- Represented Affibody ABย in its strategic collaboration withย GE Healthcare to develop and commercialize Affibodyยฎ-based PET imaging tracers, with initial focus on the targets HER2 and PD-L1. ABY-025, a HER2-detecting Affibodyยฎ-based PET imaging tracer, is currently in clinical development and provides a novel non-invasive and cost-effective approach to diagnose global HER2 expression in metastatic breast cancer patients using PET imaging. The PD-L1-binding Affibodyยฎ molecule is being developed as a diagnostic tool to improve selection and monitoring of patients with immuno-oncology treatments.
- Represented BioInvent International ABย in its collaboration withย Transgene S.A.ย to co-develop next generation oncolytic virus candidates encoding a CTLA-4 antibody sequenceโpotentially with additional transgenesโcapable of treating multiple types of solid tumors. Under the terms of the agreement, Transgene will contribute its virus design and engineering expertise and BioInvent will provide its cancer biology and antibody expertise as well as anti-CTLA-4 monoclonal antibody coding sequences.ย The collaborationโs research and development costs, and revenues and royalties from candidates generated by the collaboration, will be shared 50:50.
- Representedย BioInvent International AB in its collaboration and license agreement withย Pfizer Inc.ย to undertake a research collaboration to discover and develop novel immuno-regulatory antibodies to treat cancer. BioInvent will apply its unbiased translational drug discovery platform (โF.I.R.S.T.โ) to identify novel oncology targets and therapeutic antibodies targeting tumor-associated myeloid cells. BioInvent received approximately $10 million in early payments, including an upfront payment, early research funding and an equity investment, and was eligible for potential future development milestone payments of more than $0.5 billion through the term of the deal, as well as double digit royalties on sales of products that result from the collaboration.
- Represented Nuevolution A/Sย (later acquired by Amgen) in its multiple complex collaborations and license agreements including those with Janssen Biotech, Inc., Novartis Pharma AG, Cancer Research Technology Ltd., Merck Sharp & Dohme Corp., and Amgen, Inc. to develop and commercialize novel therapeutics in the areas of oncology, neuroscience, infectious and inflammatory diseases.
- Represented Alligator Bioscience ABย in its license agreement withย Biotheus Inc. granting rights to Biotheus in Greater China to an antibody from ALLIGATOR-GOLDยฎ for the creation of up to three bispecific molecules, with an option to expand the license to global rights. The agreement includes an upfront payment to Alligator of $1 million, and Alligator is also eligible to receive upfront, milestones and option fees of up to a total of approximately $142 million, plus royalties on future sales and share of sublicense revenue.
- Represented Affibody ABย in its agreements withย Amylin Pharmaceuticalsย (later acquired byย MedImmune/AstraZeneca),ย Biotest AG, Daiichi Sankyo Company Limited, Daewoong Pharmaceutical Co., Ltd.ย andย AbClon, Inc.ย for the use of Affibodyโs proprietary Albumodโข platform, which is designed to enhance the efficacy of biopharmaceuticals by extending their circulatory half-life, with undisclosed molecules from the partnersโ pipelines of proprietary protein therapeutics. Affibody will receive up-front and milestone payments as well as royalties on sales for licensing of the platform technology.
Products in Development and Approved Products
- Represented Xspray Pharma AB in its Commercialization Agreement with EVERSANA Life Science Services, LLC for the launch and commercialization of Xsprayโs innovative cancer therapy, Dasynoc, for the treatment of chronic myeloid leukemia and acute lymphatic leukemia. The deal will help bring innovative therapy to CML and AML patients, entering a $3.5B market for tyrosine kinase inhibitors in the US.
- Represented Pathos AI, Inc. (Pathos) in its license from Forma Therapeutics, Inc., a subsidiary of Novo Nordisk, of all rights, title and interest in Formaโs CBP/p300 inhibitor known as FT-7051 for the treatment of metastatic castration-resistant prostate cancer and other diseases
- Represented Rallybio Corporation in its acquisition of worldwide exclusive rights to Sanofiโs KY1066 (RLYB331 going forward), a preclinical potentially first-in-class antibody. RLYB331 has the potential to address a significant unmet need for patients with severe anemia with ineffective erythropoiesis and iron overload, such as beta thalassemia (BT) and a subset of myelodysplastic syndromes (MDS), amongst others.
- Represented Affibody ABย in its license and collaboration agreements withย ACELYRIN, Inc. and Inmagene Biopharmaceuticals to develop and commercialize Affibodyโs product, izokibep or ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Under the terms of the ACELYRIN agreement, Affibody received a $25 million upfront payment and is eligible to receive up to $280 million in additional regulatory and sales milestones, plus royalties on sales in the markets covered by the agreement. Under the terms of the Inmagene agreement, Affibody received a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in several major Asian markets.
- Represented Notable Labs, Inc. in the acquisition of development and commercialization rights in Volasertib from Oncoheroes Biosciences Inc. for uses that include leukemias and lymphomas, including acute myeloid leukemia (AML). Volasertib is a Polo-like kinase 1 (PLK-1) inhibitor with demonstrated activity in AML and other tumor types with significant unmet medical needs. Notable intends to leverage its proprietary predictive precision medicines platform to accelerate clinical trial timelines and maximize patient outcomes.
- Represented CoRISMA MCS Systems Inc. a medical device company focused on implantable circulation systems for patients with heart conditions, in its transaction with China Grand Pharmaceutical and Healthcare Holdings Limited pursuant to which CoRISMA granted certain development and commercialization rights to China Grand Pharma in Greater China and various regions throughout Asia for undisclosed financial terms and which was accompanied by a $27 million Series A financing round led by China Grand Pharma.
- Representedย Swedish Orphan Biovitrum AB (Sobi)ย in its original and expanded Donation Collaboration Agreement withย Sanofiย and theย World Federation of Hemophilia to bring an unprecedented 1 billion IUs of hemophilia product to patients in need around the world. In addition to donations of product, the companies will continue to provide financial support for initiatives such as treatment, access and education programs.
- Represented Notable Labs, Inc. in its co-development and profit-sharing agreement with CicloMed to use its precision oncology diagnostic test in the research and development of CicloMedโs CicloProx Prodrug in the treatment of AML.
- Represented Photocure ASAย in its agreement withย Ipsen Pharma SAS for the return of Hexvixยฎ sales, marketing and distribution rights in Europe and other markets that had been controlled by Ipsen. Hexvix is Photocureโs optical molecular imaging agent for the diagnosis of bladder cancer. Starting in 2011, Ipsen served as a strategic partner and has built a solid position for the brand in select key European markets. Photocure has now regained the global commercialization of Hexvix.
- Represented Photocure ASAย in its agreements withย Asieris Meditech Co., Ltdย for exclusive rights to register and commercialize Hexvix in Mainland China and Taiwan, and world-wide license rights to develop and commercialize Photocureโs product, Ceviraยฎ. Cevira is a fully integrated drug delivery and light device, for the treatment of HPV-induced cervical precancerous lesions and has the potential to be developed into the standard of care for the treatment of HPV infections and precancerous lesions.
- Representedย Swedish Orphan Biovitrum AB (Sobi)ย in its expanded agreement withย Sanofi for the development and commercialization of BIVV001, an investigational extended half-life factor VIII therapy with the potential to provide once-weekly dosing for people with hemophilia A.ย In connection with Sobiโs rights, Sobi made a $50 million commitment to Sanofi and became a development partner in the program.ย Upon approval in the EU, Sobi will pay the balance of its share of development costs incurred for BIVV001 and royalties on sales in the Sobi territory (Europe, North Africa, certain countries in the Middle East, and Russia) and will receive royalties from Sanofi on sales in North America and other markets.
- Represented Rallybio IPA, LLCย in its acquisition of two orphan drug programs, NAITgam and a follow-on therapy, fromย Prophylix AS. NAITgam is an antibody in early clinical development for the treatment of fetal and neonatal alloimmune thrombocytopenia (FNAIT), a potentially disabling or life-threatening disorder in fetuses and newborns, and has received Orphan Drug Designation from the FDA and EMA for prevention of FNAIT. [Under the terms of the agreement, Prophylix received an upfront payment, and is eligible for development milestones, a percentage of a Priority Review Voucher (if granted), and single to low double-digit tiered royalties on sales of NAITgam and the follow-on therapy.]
- Represented Affibody ABย in its collaboration and license agreement withย Alexion Pharmaceuticals, Inc.ย to co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated autoimmune diseases. Under the terms of the agreement, Affibody was eligible to receive up to $650 million in upfront payments, and development and sales milestones, and tiered low double-digit royalties.
- Represented Swedish Orphan Biovitrum AB (Sobi)ย in its exclusive license and acquisition of global rights for emapalumab fromย Novimmune SA. Emapalumab is an orphan drug that addresses a high unmet medical need in primary haemophagocytic lymphohistiocytosis, a rare and life-threatening syndrome of extreme immune activation. Under the terms of the agreement, Sobi will make an upfront payment of 50 million Swiss francs and additional milestone payments of 400 million Swiss francs.
Representative Mergers and Acquisitions Transactions
The following is a list of representative mergers, acquisitions and divestments in which Wiggin and Dana acted as lead counsel for clients in the biotechnology, pharmaceutical and medical device industries. Each transaction is described according to its status upon completion of the transaction.
- Represented AlloMek Therapeutics, LLC, an innovator in MEK-associated orphan diseases, in its acquisition by Pasithea Therapeutics Corp.
- Acted as United States counsel to Swedencare AB, a veterinary supplies company, in its $447 million acquisition of Naturvet, a leading supplier of pet supplements, and its earlier acquisition of Vetio Animal Health Group.
- Represented Ximedica, LLC, a medical device development company, in its sale to Veralent, Inc., an affiliate of Summit Partners.
- Represented AptarGroup, Inc. in its acquisition of substantially all of the operating assets and proprietary portfolio of Cohero Health, Inc., a digital respiratory health company.
- Represented CAS Medical Systems, Inc. in its sale, via cash-out merger, to a subsidiary of Edwards Lifesciences Corporation.
- Representedย Olink Proteomics Holding AB in the sale ofย Olink Proteomicsย toย Summa Equity, a Swedish-based private equity firm that focuses on investments in companies that help solve global challenges.ย Olink Proteomics is a life science company that has developed a unique technology for human biomarker discovery.
- Representedย Cormorant Pharmaceuticals AB in its stock purchase agreement in connection with the sale toย Bristol-Myers Squibb Companyย (BMS)ย of all of Cormorantโs outstanding capital stock and in which BMS obtained full rights to Cormorantโs lead antibody candidate, HuMax-IL8. HuMax-IL8 is a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules. Payments by BMS to the Cormorant equity holders could reach a total of $520 million if all clinical and regulatory milestones are achieved.
- Representedย Probi AB, a Swedish publicly traded bioengineering company that develops probiotics, in its $105 million acquisition of the assets and operations ofย TNTGamble, Inc.d/b/aย Nutraceutix, a Washington State-based manufacturer and supplier of probiotics.
- Representedย Gyros AB, a pioneer in automated nanoliter-scale immunoassays, in its merger withย Protein Technologies AB, a leading provider of peptide synthesis instrumentation and reagents.
- Representedย Galecto Biotech AB in its agreement withย Bristol-Myers Squibb Company (BMS)ย for the exclusive option to acquire Galecto and gain worldwide rights to its lead asset, TD139, a novel inhaled inhibitor of galectin-3, a product in Phase 1 development for the treatment of idiopathic pulmonary fibrosis and other pulmonary fibrotic conditions. Under the agreement, Galecto will receive up to US$444 million if BMS exercises its option and all contingent payments are made.
- Representedย Premacure Holding AB in the sale toย Shire plcย of Premacure AB, a company that is developing a protein replacement therapy for the prevention of retinopathy of prematurity (ROP), a rare and potentially blinding disorder that inflicts primarily premature infants. Shire purchased Premacure AB for an upfront payment and certain contingent payments based on the achievement of pre-specified development and commercial milestones.
- Representedย CGI Pharmaceuticals, Inc.in connection with its merger into a wholly-owned subsidiary ofย Gilead Sciences, Inc.ย in exchange for cash consideration of up to US$120 million.