MaureenBennett

Partner

波士顿 + 1.617.449.6884 旧金山 + 1.415.875.5772

Maureen Bennett represents life sciences and health care clients conducting global clinical trials and research collaborations. For almost 20 years, Maureen has advised clients on the contractual, regulatory, and ethical issues associated with clinical research. She negotiates clinical trial agreements, reviews informed consents, provides advice regarding novel patient recruitment strategies, and assists with interactions with regulatory agencies, including the U.S. Food & Drug Administration (FDA).

She has advised health care systems and life sciences companies regarding the conduct of global trials for therapeutics and vaccines to address COVID-19.

Maureen advises clients on emerging regulatory issues affecting clinical research, including the utilization of social media in patient and physician recruitment, the development of virtual clinical trial and telemedicine networks, and personalized medicine strategies implementing the use of biomarkers and companion diagnostics.

Maureen also represents clients in the structuring of complex outsourcing arrangements between life sciences companies and contract research organizations (CROs). She has advised entities in the establishment of compliant decentralized clinical trials.

She also represents clients in the assessment and mitigation of regulatory risks and the negotiation of liability allocation arrangements in M&A, licensing, and other commercial transactions.

Maureen is the life sciences co-leader for the Firm's Health Care & Life Sciences Practice and formerly served as co-chair of the Boston Bar Association's Health Care Section. She was honorary co-chair for the 8th Annual Boston-Northwest Ireland Golden Bridges Giant Step Conference 2020 and is a regular speaker at industry conferences. Maureen is co-chair of the Firm's LGBTQ affinity group.

经验

  • Astellas acquires Iveric bioJones Day is advising Astellas Pharma Inc. in the $5.9 billion cash acquisition of Iveric bio, Inc., a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.
  • KKR acquires IVI-RMA GlobalJones Day acted as U.S. counsel in the €3 billion acquisition of IVI-RMA, a group specialized in assisted reproduction techniques.
  • Parker Hannifin sells Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc.Jones Day represented Parker Hannifin Corporation in the sale of its Human Motion and Control Business Unit to Ekso Bionics Holdings, Inc. for an aggregate purchase price of $10 million.
  • EDAP completes follow-on public offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on public offering of 3,066,667 American Depositary Shares (ADSs) on the Nasdaq Global Market.
  • Riverside portfolio company acquires Jupiter Life Science Consulting (Jupiter)Jones Day advised The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of Jupiter Life Science Consulting (Jupiter), a leading provider of commercial and market access strategies for global pharma, biotech, and medical device companies with its primary focus in rare disease, hematology/oncology, metabolic, and neurology therapeutic areas.
  • Cardinal Health acquires the Bendcare CPO-GPO entity and makes a minority investment in the Bendcare MSOJones Day advised Cardinal Health, Inc. in the acquisition of the Bendcare group purchasing organization (CPO-GPO) entity and a minority investment in the Bendcare management services organization (MSO).
  • Riverside portfolio company acquires Medical Marketing Solutions GroupJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company Medical Marketing Solutions Group (MMSG), a leading medical education company that provides strategic services, scientific and medical communications, and operational and event management services to global biopharmaceutical companies.
  • City of Hope acquires Cancer Treatment Centers of AmericaJones Day advised City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, in connection with its acquisition of Cancer Treatment Centers of America, a network of oncology hospitals and outpatient care centers across the United States.
  • Sotera Health acquires Regulatory Compliance AssociatesJones Day advised Sotera Health in the acquisition of Wisconsin-based Regulatory Compliance Associates, Inc.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • Bridge to Life announces first close of $56 million growth financingJones Day advised Bridge to Life, Ltd. in its $56 million capital raise consisting of a secured credit facility and a Series A preferred equity investment.
  • EDAP completes follow-on offering of American Depositary SharesJones Day represented EDAP TMS, a global leader in robotic energy-based therapies, in connection with its follow-on offering of 4,150,000 American Depositary Shares (ADSs) on the Nasdaq Global Market.
  • MedShape acquired by DJOJones Day advised MedShape, Inc., a privately held orthopedic medical device company founded in 2005, in connection with its acquisition by DJO, a subsidiary of Colfax Corporation.
  • Riverside portfolio company acquires PPM Advisory Group and OrtleyBioJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus of PPM Advisory Group and OrtleyBio, leading providers of scientific operations and communications services to global biopharmaceutical companies and brands, with a primary focus on oncology and hematology therapeutic areas.
  • Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.
  • AbbVie acquires Mitokinin, Inc.Jones Day advised AbbVie Inc. in its exclusive right to acquire Mitokinin, Inc., a biotechnology company developing PINK1-targeted therapeutics for the treatment of neurodegenerative diseases, following completion of IND enabling studies on Mitokinin's lead PINK1 compound.
  • Riverside portfolio company acquires iTakeControlJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus, a premier provider of learning, performance, and process solutions for the life sciences industry, of iTakeControl, a leading provider of clinical operations and medical affairs technology and services focused on rare disease and specialty pharma.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • H.C. Wainwright underwrites Nasdaq IPO by Biophytis, including issuance of 1.2 million American Depositary SharesJones Day advised H.C. Wainwright, as underwriter, in connection with the Nasdaq IPO by Biophytis S.A., a French Euronext Growth-listed biotech company, including the issuance of 1.2 million American Depositary Shares (ADSs).
  • STERIS acquires Key Surgical for approximately $850 millionJones Day advised STERIS plc (NYSE: STE) in the $850 million acquisition of Key Surgical, a leading global provider of sterile processing, operating room, and endoscopy products, and a portfolio company of Water Street Healthcare Partners, LLC.
  • The following represents experience acquired prior to joining Jones Day.

    Advised a Japanese life sciences company with its proposed acquisition of a U.S. contract manufacturing organization.

    Advised a U.S. health care system with its expansion of a unique, personalized medicine-based clinical research study to sites in the Middle East and Europe and advised on related U.S. IDE regulatory issues.

    Advised a U.S.-based biotech company with a multicountry analysis of statutory and ethical committee requirements to provide access to study a drug after completion of a clinical trial and assisted the company with development of clinical trial agreements, informed consent, and related regulatory issues in several South American jurisdictions.

    Advised a U.S.-based genetics company with laboratory testing agreements, data protection, and other regulatory issues in connection with genetics testing arrangements in the U.K. and Russia.

    Advised a U.S.-based biotech company with the development of informed consent and data privacy authorizations for use in the U.S., Australia, and multiple European jurisdictions.

    Assisted a Japanese life sciences company with several confidential buy- and sell-side transactions.

    Assisted a U.K.-based specialty pharmaceutical company in connection with the development of policies regarding the payment of health care professionals and anticorruption issues in Hong Kong, Taiwan, and Singapore and with the development of compliant centers of excellence product training programs in Hong Kong and Japan.

    Assisted a specialty patient recruitment firm with analysis of subject recruitment and advertising regulations in multiple ex-U.S. jurisdictions.

    Assisted a top three pharmaceutical company, on an outsourced basis, with the negotiation of more than 150 clinical trial agreements in nine South and Central American jurisdictions.

    Assisted a clinical data management provider in establishing a commercial agreement with a top three global pharmaceutical company, including providing legal analysis of pharmacovigilance transactions in a number of jurisdictions, including Japan, China, India, multiple EU jurisdictions, and the U.S.

    Drafted and negotiated pharmaceutical product distribution agreements on behalf of California-based company for Australia and New Zealand markets.

    Drafted and negotiated collaboration agreement between a top three pharmaceutical company and National Comprehensive Cancer Network regarding grant arrangements and a series of investigator-initiated trials in the oncology space.

    演讲

    • October 5, 2017
      Belfast UK International Homecoming-Legal Symposium, "Marriage Equality and the Courts in the U.S."
    • November 9, 2016
      Jones Day Global Life Sciences Conference – 2016 Issues & Trends
    • October 21, 2016
      ABA Life Sciences Legal Summit
    • May 4, 2016
      Compliance in the Precision Medicine Era: Legal Considerations for the Contemporary Life Sciences Industry
    • March 7, 2016
      Boston Bar Association - Are You Ready? The Frontiers of Clinical Research and the Evolving Common Rule
    • December 2, 2015
      Boston Bar Association CLE - Medical Tourism: Legal Issues and Ethical Implications
    • October 23, 2015
      Treating the Medical Tourist: Issues for Healthcare Providers and Their Counsel, ABA Section of International Law 2015 Fall Meeting
    • October 21-22, 2015
      8th Annual Boston-Northwest Ireland Golden Bridges Giant Steps Conference - Honorary Co-Chair and Shark Tank Judge
    • October 2015
      The Legal and Ethical Implications of Medical Tourism, panel discussion
    • March 4, 2015
      Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker