Sarah Cooleybeck

Partner - Boston

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Sarah Cooleybeck, a partner in the firm’s Business Department, has a broad life sciences practice that includes negotiation of complex licensing and collaboration agreements, intellectual property and licensing advice, and Hatch-Waxman and related regulatory strategy.

Sarah drafts and negotiates patent licenses, supply, manufacturing and quality agreements, collaboration and co-development agreements, and other strategic alliances, for both established and emerging companies. Sarah’s licensing work is complemented by her in-depth knowledge of the regulatory environment in which life sciences companies operate, and by her patent litigation experience.

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Education:

  • Harvard Law School, J.D., cum laude, 1995
  • University of Michigan, A.B., high honors, 1990

Representative Experience

  • Represented Intellia Therapeutics, Inc. (Nasdaq: NTLA), in a cross-border collaboration with SparingVision using Intellia’s proprietary CRISPR/Cas9 platform to develop new gene therapies directed to up to three ocular targets, under which Intellia will receive a 10% equity ownership stake in SparingVision, milestone payments of up to approximately $200 million per product, and royalties, as well as an option to US commercialization rights for two of three targets. 
  • Advised Ginkgo Bioworks (Nasdaq: DNA) in various collaboration and license agreements, including:
    • a supply agreement with Twist Bioscience (Nasdaq: TWST) under which Twist will supply high volumes of synthetic DNA to support Ginkgo’s fast-growing cell programming platform, increasing the depth and breadth of the existing collaboration between the two 
    • with Agenus (Nasdaq: AGEN) and its subsidiary SaponiQx to develop saponin molecules for high-efficacy and long-lasting protection for pandemic vaccines
    • with Cambium Biomaterials for the development and commercialization of sustainable biomaterials for use in applications across a range of industries
    • with Givaudan to accelerate development and enhance Givaudan's portfolio of taste and scent ingredients
    • with Sumitomo Chemical Co. to significantly increase the production efficiency and sustainability of a key bio-based commercial product
    • with Biogen (Nasdaq: BIIB) to develop a next-generation recombinant adeno-associated virus (AAV) production platform
  • Represented Dicerna Pharmaceuticals in a global collaboration and license agreement with Roche to develop and commercialize a treatment for chronic Hepatitis B Virus (HBV) infection, for more than $1.67 billion in upfront and milestone payments, plus royalties
  • Represented LG Chem Life Sciences in a $900+ million multi-target, strategic collaboration announced with CUE Biopharma that provides LG Chem with the Asia rights to Cue Biopharma’s lead immuno-oncology CUE-101 program, products in two other programs, and a worldwide option for another antigen-focused biologic
  • Advised Ginkgo Bioworks, Inc. (Nasdaq: DNA) in the launch of Concentric by Ginkgo, the company’s public health and biosecurity initiative, to provide COVID-19 testing solutions to states, cities and school districts
  • Drafted and negotiated a broad range of licensing, collaboration, co-development and option agreements for medical device, pharmaceutical, biotechnology and other clients, including:
    • Represented global biopharmaceutical company Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) in a partnership with Complement Pharma to co-develop a pre-clinical C6 complement inhibitor for neurodegenerative disorders 
    • Represented Homology Medicines to license gene editing platform technology from City of Hope and AAV technology from Caltech
    • Advised medical diagnostics company Alere Inc. on licensing and intellectual property matters associated with potential sale of health care division
    • Negotiated licenses, sponsored research agreements, material transfer agreements, and options with academic institutions including MIT, Stanford, Michigan State, Yale, Columbia and Caltech
  • Drafted and negotiated dozens of U.S. and international manufacturing, supply, quality, and distribution agreements in the life sciences industry, including:
    • Negotiated development, supply and distribution agreements for robotic surgical instruments on behalf of the U.S. subsidiary of a major Japanese conglomerate
    • Advised start-up company regarding agreements for development of device manufacturing processes, and manufacture and optimization of drug-filling equipment and processes
    • Represented drug delivery company on license of drug delivery device technology and related multi-party device and drug product supply agreements
  • Advised and represented life sciences companies on Hatch-Waxman, Paragraph IV, FDA regulatory, and related patent and licensing issues, including:
    • Represented pharmaceutical companies in seeking Hatch-Waxman patent term extension and FDA regulatory exclusivity
    • Represented large biotechnology company in various disputes arising out of complex collaboration and license agreements
    • Advised health care company in connection with Paragraph IV patent infringement litigation against generic drug companies regarding therapeutic drug for end-stage renal disease, and resolved dispute regarding supply agreement for same drug
  • Co-author “Checklist for Life Sciences Licensing and Development Agreements” Drafting & Negotiating Joint Venture, Licensing, Co-Development, Marking & Distribution Agreements (MCLE, Inc. 2014)
  • "Current Issues in Hatch-Waxman Litigation: Moving Beyond the Caraco Dispute to the Question of Induced Patent Infringement in the Marketplace," The IP Legal Browser (Winter 2012)

Honors

  • Harvard Law School, Harvard Law Review, Editor
  • Served as a law clerk to Judge Patti B. Saris of the United States District Court for the District of Massachusetts

Involvement

  • Board Member, Boston IP American Inn of Court 
  • Boston Patent Law Association
  • Boston Bar Association
  • American Intellectual Property Law Association (AIPLA)
  • “Overview of Patent and Trademark Issues:  IP Protection for Drugs and Biologics” at American Conference Institute (ACI) FDA Boot Camp (Sept. 2012)
  • “Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies” at American Conference Institute (ACI) FDA Boot Camp Master Class (Sept. 2012)
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Bar Admissions

  • Massachusetts

Court Admissions

  • U.S. District Court for the District of Massachusetts
  • U.S. Court of Appeals for the First Circuit
  • U.S. Court of Appeals for the Federal Circuit