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Lauren Pignataro Rakitin

Partner

Washington +1 202 662 5657

  • About
  • Representative Matters
  • Credentials
  • About

    Lauren Pignataro Rakitin specializes in transactional matters in the life sciences industry, with a particular focus on complex strategic collaborations and licensing arrangements. Lauren advises a broad range of clients, from start-up and biotech companies to global pharmaceutical companies. By focusing exclusively in the life sciences industry, Lauren has established a deep understanding of the complex needs of pharmaceutical and biotechnology companies as they navigate the life cycle of their products, from discovery and development to commercialization and generic/biosimilar entry.

    Lauren routinely advises on:

    • strategic licensing and collaboration agreements for the discovery, development and/or commercialization of life sciences products;
    • in-licensing of foundational IP and out-licensing of IP that is no longer core to the portfolio to unlock further value; and
    • commercial agreements, including CRO, clinical trial, manufacturing, co-promotion and distribution agreements.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • AstraZeneca in its collaboration with Akcea/Ionis to develop and commercialize eplontersen, Ionis' investigational antisense medicine designed to reduce the production of transthyretin, or TTR protein, to treat transthyretin amyloidosis (ATTR), a systemic, progressive and fatal disease, which involved an upfront payment of $200M, up to $485 million in development and approval milestones, up to $2.9 billion in sales-related milestone payments, and royalties.
    • AbbVie in its global collaboration agreement with I-Mab for the development and commercialization of lemzoparlimab (also known as TJC4), an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers, which involved a $180M upfront payment, $20 million in a milestone payment based on the Phase 1 results, and $1.74B in success-based milestone payments.
    • Takeda Pharmaceutical Company Limited in its research collaboration and license agreements with Memorial Sloan Kettering Cancer Center to discover and develop novel chimeric antigen receptor T-cell (CAR-T) products for the treatment of multiple myeloma, acute myeloid leukemia and additional solid tumor indications.
    • Regeneron Pharmaceuticals in a strategic collaboration with Zai Lab Limited for the development and commercialization of REGN1979 (CD20xCD3 bispecific antibody) in mainland China, Hong Kong, Taiwan and Macau, which involved global development cost-sharing, a $30 million upfront payment and up to $160 million in regulatory and sales milestones.
    • Merck in an amendment to its existing collaboration agreement with NGM Biopharmaceuticals, which extended the collaboration and provided an additional $120M in R&D funding but narrowed the focus to primarily retinal and cardiovascular and metabolic (CVM) targets of interest to Merck.

    • Aegle Therapeutics in connection with a license agreement with University of Miami, pursuant to which Aegle received rights to intellectual property concerning its technology platform for isolating extracellular vesicles including exosomes secreted by allogeneic bone marrow-derived mesenchymal stem cells.
    • Allergan in its out-license to Allgenesis Biotherapeutics of exclusive global rights to Allergan's formyl peptide receptor (FPR) program for ophthalmology.
    • Humacyte, Inc. in support of all aspects of its Phase 2 and Phase 3 clinical studies, including CRO arrangements, services agreements and clinical trial agreements.
    • Multiple innovator pharmaceutical companies in license agreements to settle Hatch-Waxman patent litigation.
    • AbbVie in its exclusive strategic collaboration and option agreement with Voyager Therapeutics to develop and commercialize vectorized antibodies directed against tau for the treatment of Alzheimer's disease and other neurodegenerative diseases. Under the terms of the agreement, Voyager is entitled to an upfront cash payment of $69 million as well as up to $155 million in potential preclinical and Phase 1 option payments, as well as up to $895 million in development and regulatory milestones for each vectorized tau antibody compound and tiered royalties on the global net sales of the vectorized antibodies for tauopathies.

    Areas of Expertise

  • Credentials
    Education
    • New York University, LL.M., 2017
    • New York University School of Law, J.D., 2014
        • Honors
        • magna cum laude
        • Order of the Coif
        • NYU Review of Law and Social Change
    • Cornell University, B.S., 2011
        • Honors and Distinction
    Bar Admissions
    • District of Columbia
    • New York
    Judicial Clerkship
    • Hon. Nelson S. Román, U.S. District Court, Southern District of New York, 2015 - 2016
    Pro Bono
    • Represented World Central Kitchen in connection with various contracts required to provide meals in response to humanitarian, climate, and community crises, including in connection with the Ukraine refugee crisis.
    • Represented Michael Mosier Defeat DIPG Foundation in connection with a grant agreement to support an expanded access program for ONC201, an experimental drug currently being tested to treat DIPG (an aggressive brain tumor that largely affects children).
    • Advised a District of Columbia nonprofit organization in its dissolution, including sales of major assets, real estate dispositions, debt settlements, and filings for dissolution.
    • Advised a District of Columbia nonprofit organization in its restructuring, including the transfer of membership interests in a related Maryland limited liability company.
    • Advised a New York nonprofit organization regarding maintaining 501(c)(3) status and receiving charitable contributions. 
    Memberships and Affiliations
    • AnBryce Foundation, Board Member

    Areas of Expertise

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