Life Sciences

Our Life Sciences industry team focuses on solutions for innovative life sciences companies at all stages—from startups to established companies, pre-clinical through commercialization. Our lawyers combine comprehensive legal expertise with deep industry knowledge to provide our clients with effective, timely solutions to meet their business objectives. We are nationally recognized in the Licensing & Collaboration category of the 2022 LMG Life Sciences rankings, the only law firm headquartered in North Carolina to receive this honor. Additionally, Smith Anderson's Life Sciences practice is routinely across the table from the largest law firms in the world, leading transactions that have received premiere awards such as the Life Science sector Deals of Distinction™ award by the Licensing Executives Society, and the LMG Life Sciences Collaboration Impact Deal of the Year award.

Our clients include start-up companies and university spin-outs, venture capital-backed companies and publicly-traded companies. These companies span the life sciences industry, such as biotechnology, biopharmaceuticals, pharmaceuticals, medical devices, medical technology, tools and diagnostics, and contract research and marketing organizations. We also advise life sciences-focused investors including venture capital and private equity firms as well as corporate investors (including fund formation). Our team works with companies with global footprints, whether based in the Research Triangle region or based outside of the region, nationally and internationally.

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We have decades of experience providing a broad range of services for our life sciences clients, including mission critical licensing and collaboration transactions and corporate partnering, mergers and acquisitions, venture capital and other private and public financings, manufacturing, supply and distribution agreements, and a variety of other financing, commercial and corporate matters. 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 pharmaceutical and the agricultural technology sectors, covering all major gene editing technologies from CRISPR to TALEN and other nucleases.

As a full-service law firm, we also help our life sciences clients achieve their goals through our litigation and dispute resolution practice and by advising on labor and employment matters, employee compensation and benefits, tax strategies, real estate and facilities leasing and acquisition, government relations, and other key matters.

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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

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

• Development and license agreement, valued at approximately $2.7 billion, between venture capital-funded genome editing company and a global pharmaceuticals company to develop and commercialize in vivo gene editing therapies for treatment of various genetic disorders, including Duchenne muscular dystrophy. 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

• 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.
• Divestment by our client, a global pharmaceutical company, of pharmaceutical product rights to a specialty pharmaceutical company.
• License and acquisition by our client, a specialty pharmaceutical company, of pharmaceutical intellectual property from a global pharmaceutical company and related sub-licenses from other global pharmaceutical companies.
• $400 million acquisition of our client, a venture-backed agricultural biotechnology company, by a global pharmaceutical and agricultural company.
• $155 million acquisition of our client, a biotechnology company, by a global pharmaceutical and animal health company.
• $150 million acquisition by our client, a public specialty pharmaceutical company, of a private specialty pharmaceutical company.
• Acquisition by our client, a middle market private equity fund, of a single-source regulatory, compliance, pharmacovigilance and medical information service provider.
• Acquisition by our client, a private equity fund, of a leading contract development and manufacturing organization (CDMO).
• Acquisition by our client, a global contract research organization and drug development services company, 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

• $145.4 million initial public offering by our client, a genome editing company.
• $525 million notes offering by our client, a global biopharmaceutical services company.
• $60 million venture capital financing by our client, a biotechnology company.
• Private placement offering of securities by our client, a university spin-out, to accredited investors.