Counsel to Life Sciences Companies Worldwide

Overview

Our Life Sciences industry team works with companies throughout the world, focusing on solutions for innovative life sciences companies at all stages—from startups to established companies, pre-clinical through commercialization. We are nationally recognized in the Licensing & Collaboration category of the LMG Life Sciences rankings, the only law firm based in North Carolina to receive this honor, among other accolades. Smith Anderson's Life Sciences practice has led transactions that have received premier awards such as the Life Science sector Deals of Distinction™ award by the Licensing Executives Society, and multiple LMG Life Sciences Collaboration Impact Deal of the Year awards.

Our clients include publicly-traded companies, privately held multi-nationals, private equity and venture capital-backed companies, alongside start-up companies and university spin-outs. These companies span the life sciences industry, including biotechnology, pharmaceuticals, medical devices, medical technology, diagnostics, manufacturers, and contract research organizations. We also advise life sciences-focused investors, including venture capital and private equity firms, as well as corporate investors.

We have decades of experience providing a broad range of services, including structuring and negotiating mission critical licensing, collaboration, and corporate partnering transactions, mergers and acquisitions, manufacturing, supply and distribution agreements, research and development agreements, clinical trial and CRO agreements, and a variety of other strategic and complex transactions. These matters involve transactions across a range of stages of product development. Among other areas of deep experience, our firm is internationally known for its extensive experience in representing companies in licensing and collaboration transactions related to genome editing technology in both the human health and the agricultural technology sectors, covering all major gene editing technologies.

As a full-service law firm, we also support our life sciences clients in achieving their business objectives by advising on intellectual property protection, strategic alliances and joint ventures, venture capital and other private and public financings and fundraising, corporate governance, securities law compliance, labor and employment matters, employee compensation and benefits, tax strategies, real estate and facility leasing, buildouts, and acquisitions, government relations, and litigation and dispute resolution.

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Services

Research, development and commercialization collaborations
Partnering, strategic alliance and joint venture arrangements
Mergers and acquisitions
Product and asset acquisitions and divestitures
Intellectual property and technology licensing and transfer
Early stage financing, venture capital, initial public offerings and other equity and debt financings
Clinical trial and CRO agreements
Manufacturing, supply and distribution agreements
Vendor contracting
Company formation, structuring and governance
Dispute resolution

Experience

Corporate Partnering and Licensing, Including R&D, Manufacturing and Commercialization

Counseled a publicly traded biopharmaceutical company in a research and collaboration agreement for drug candidates identified using proprietary platform, with total transaction value in excess of $545 million plus royalties.
Represented a global company headquartered in South Korea in a global exclusive licensing agreement to allow a US-based pharmaceutical company to further develop and market a small molecule genetic obesity drug.
An early stage, venture-backed company developing treatments for inherited retinal diseases, acquired the rights to two preclinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from a publicly-traded biotechnology company.
Advised an international research-focused healthcare group/the global rare diseases division of an international research-focused healthcare group in an in-license of pharmaceutical delivery technology for up to $141 million in upfront and milestone payments plus royalties.
Represented a publicly traded biopharmaceutical company in a license agreement to develop drug products using a proprietary platform, with total transaction value in excess of $615 million plus royalties.
Represented startup gene therapy company in university in-license transaction.
Represented a Nasdaq-listed specialty pharmaceutical company in the out-license of pharmaceutical product IP rights in Japan for upfront and milestone payments, plus royalties.
Advised a leading genome editing company in an approximately $1.5 billion collaboration and licensing agreement with one of the largest pharmaceutical companies worldwide.
Represented an international health care group in an exclusive license and collaboration agreement with a venture-backed biotechnology company to develop innovative monoclonal antibodies to treat cardiopulmonary diseases.
Represented publicly-traded Japanese biotechnology company in collaboration and license agreement for development of peptide-based pharmaceuticals.
Advised a leading genome editing company in an approximately $180 million collaboration to acquire rights to a tolerizing and lymphodepleting agent.
Represented a biomedical startup in a patent license agreement with a leading research university that has potential milestone payments exceeding $2,500,000.
Advised a global pharmaceutical company in a development and commercialization license for development of a small molecule pharmaceutical product for orphan disease, with total transaction value of $350 million plus royalties.
Advised a China-based biopharmaceutical company on its world-wide Intellectual Property License and Collaboration Agreement with a U.S. publicly-traded, clinical-stage biotechnology company.
Represented leading cell therapy investor in acquiring rights to immuno-ongology technology from a leading university.
Represented a leading genome editing company in its approximately $2.7 billion research collaboration, including an upfront payment of $135 million, with a global, publicly-traded pharmaceutical company to develop and commercialize gene editing-based gene therapies for up to six targets. This agreement won a 2021 "Impact Deal of the Year" award from LMG Life Sciences.
Worldwide partnership, worth up to $1.6 billion, including an upfront payment of $105 million, with a global, publicly-traded pharmaceutical company to develop and commercialize allogeneic chimeric antigen receptor (CAR) T cell therapies for multiple cancers. The transaction was awarded the 2016 Life Science sector Deals of Distinction™ award by the Licensing Executives Society.
Licensing transaction for an international health care group and its U.S. specialty pharmaceutical company subsidiary in obtaining multinational rights to three cardiovascular drugs from a large public pharmaceutical company for $264 million in cash at closing, up to $480 million in milestone and royalty payments, and the assumption of up to $50 million in milestone payment obligations.
Licensing counsel to a leader in developing innovative products from the Earth’s microbial communities in a transaction under which one of its subsidiaries joined the portfolio of a Cambridge-based cell and gene therapy holding company.
Development agreement for a clinical stage biopharmaceutical company developing inhaled therapies to treat severe respiratory and chronic diseases in its global license with a British pharmaceuticals business to commercialize inhaled imatinib for the treatment of Pulmonary Arterial Hypertension (PAH).
Collaboration between clinical stage pharmaceutical company with the Biomedical Advanced Research and Development Authority (BARDA) to co-fund development of LBP-EC01, a CRISPR Cas3-enhanced bacteriophage (crPhage™) product that will target Escherichia coli (E. coli) bacteria causing recurrent urinary tract infections (UTIs).
Lead counsel to a clinical stage pharmaceutical company in its contract with a global non-profit to fund a program for development of LBP-KP01, a CRISPR Cas3-enhanced bacteriophage (crPhage™) product targeting the bacterial pathogen Klebsiella pneumoniae (K. pneumoniae).
Research and commercial collaboration between plant sciences company with one of the three largest banana producers in the world, to develop genome-edited varieties of bananas resistant to a new strain of “Panama disease” (fusarium wilt).
Formation and funding of pharmaceutical company by our clients, a group of venture capital investors, and the related in-license of pharmaceutical product rights from a global pharmaceutical company.
Collaboration/strategic alliance between our client, a leading pharmaceutical development company, and a global, Japanese-based pharmaceutical company for the development of pharmaceutical products on a risk-sharing basis.
Worldwide exclusive license of genome engineering technology by our client, a charitable organization that supports development of agricultural disease resistance technologies, to a global biotechnology tools company.
Worldwide exclusive license and research collaboration between our client, a biotechnology company and a leading global animal health company, to develop and commercialize animal vaccines.

Mergers & Acquisitions

Represented a publicly traded biotechnology company in the sale of certain assets and license of certain rights related to certain cell therapy platforms, in the amount of up to $227 million of upfront cash and equity plus milestone payments.
Advised a contract development and manufacturing organization (CDMO) and its private equity parent in the purchase of substantially all of the assets of a growing CDMO specializing in certain R&D partnerships and product development.
Represented a leading clinical research organization in its divestiture of two lines of business to a leading private equity firm specializing in building market-leading, technology-rich healthcare companies, in the amount of $340,000,000.
Advised a publicly-traded specialty pharmaceutical company in a sale of substantially all of its assets to a U.S.-based biopharma financing company and to an Australia-based pharmaceutical company, under Section 363 of the U.S. Bankruptcy Code.
Represented an international contract research organization in its acquisition of a medical device development company.
Advised a London-based private equity firm and a global medical technology contract research organization on the sale of the contract research organization and its subsidiaries for approximately €250,000,000 in cash and equity.
Advised a clinical-stage biotech company and its founder in a definitive agreement to be acquired by a private biotech company, in exchange for equity ownership in the buyer.
Advised a life sciences company on its acquisition of a clinical manufacturing facility for an undisclosed amount.
Advised an oncology-focused clinical research organization on the acquisition of an India-based clinical research organization developing an AI-driven clinical research software solution.
Represented a private-equity owned, industry leading contract development and manufacturing organization (CDMO) in its acquisition of a Nasdaq- listed contract development and manufacturing organization with a deal value of approximately $183 million.
Represented a biotechnology company in its acquisition via merger of an early-stage company focused on developing manufactured kidney products, for a purchase price of approximately $50 million.
Represented a publicly traded biotechnology company in the sale of certain assets and license of certain rights related to certain cell therapy platforms, in the amount of up to $227 million of upfront cash and equity plus milestone payments.
Advised a Nasdaq-listed medical device company in the acquisition of a global leader in neuromodulation and rehabilitation medical devices for up to $110 million in up-front and contingent consideration.
Advised a Nasdaq-listed pharmaceutical development company in the acquisition of a specialty dermatology company for up to $51 million in up-front and contingent consideration.
Advised a clinical-stage biotech company and its founder in a definitive agreement to be acquired by a private biotech company, in exchange for equity ownership in the buyer.
Advised a provider of identity verification data in its acquisition by a global financial information company.
Advised a provider of clinical trial contracting and payment services, and its investors, in its merger with a provider of complementary services.
Represented a global pharmaceutical company in a divestment of pharmaceutical product rights to a specialty pharmaceutical company.
Represented a specialty pharmaceutical company in a license and acquisition of pharmaceutical intellectual property from a global pharmaceutical company and related sub-licenses from other global pharmaceutical companies.
Advised a venture-backed agricultural biotechnology company in its $400 million acquisition by a global pharmaceutical and agricultural company.
Advised a biotechnology company on its $155 million acquisition by a global pharmaceutical and animal health company.
Represented a publicly-traded specialty pharmaceutical company in its $150 million acquisition of a private specialty pharmaceutical company.
Represented a middle market private equity fund in its acquisition of a single-source regulatory, compliance, pharmacovigilance and medical information service provider.
Advised a private equity fund in its acquisition of a leading contract development and manufacturing organization (CDMO).
Represented a global contract research organization and drug development services company on its acquisition of a mobile-connected self-service platform solutions for decentralized clinical trials.
Execution of an option agreement by our client with a private biotechnology company to acquire rights in a proprietary recombinant therapeutic.

Capital Markets and Financing

Represented a Nasdaq-listed pharmaceutical development company in establishing a $50 million at-the-market facility.
Represented company in raising up to $60 million in a Series B financing and related secondary financing.
Assisted client with the sale of up to $7,000,000 of Series A-4 Preferred Stock.
Represented medical device company, in its sale of up to $8.5 million of shares of Series B Preferred Stock to investors.
Represented a gene therapy company in its sale of $19 million of Series Seed Preferred Stock to various investors.
Represented a Nasdaq-listed global medical device company in its minority investment in a developer of an innovative wound healing therapy.
Represented a private investment firm in the formation of a life sciences-focused venture capital fund and in the private placement of $55,200,000 of limited partnership interests in such fund.
Represented a Nasdaq-listed pharmaceutical development company in a $40 million public offering of common stock.
$145.4 million initial public offering by our client, a genome editing company.
Represented a global biopharmaceutical services company in its $525 million notes offering.
Advised a biotechnology company on its $60 million venture capital financing.
Advised a university spin-out on its private placement offering of securities to accredited investors.