CristianaSpontoni

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Cristiana Spontoni is internationally recognized as a leader in life sciences, including biotechnology, pharmaceuticals, medical devices, food and cosmetics, as well as in general EU product and industries regulation. She is also actively involved in the shaping and interpretation of EU legislation affecting many different regulated industries and has successfully represented clients in legislative challenges based on EU law. Cristiana frequently coordinates large international assignments and provides comprehensive one-stop-shop solutions for cross-border regulatory issues affecting clients' operations. She has coordinated projects in more than 80 countries worldwide.

Cristiana advises clients from the pre-market phase, including clinical trials and pre-market authorizations, to post-market issues, including product liability, marketing/advertising, distribution, and compliance (including sector-specific antibribery and data privacy).

Cristiana handles safety and compliance issues for a large variety of clients both in the life sciences and consumer products sectors, including in regards to product regulation, crisis management (e.g., recalls), regulatory enforcement and media attacks, as well as in marketing/advertising/claims and associated substantiation matters.

Cristiana frequently speaks at and chairs major international conferences. She is recognized in the leading lawyer directories including Chambers, Legal 500, Best Lawyers, and International Who's Who and has received several important awards, including "Life Sciences Lawyer of the Year"(Corporate LiveWire 2018 Global Awards) and the ILO Client Choice Award for EU-wide Healthcare & Life Sciences. She has been named a "Star" by LMG Life Sciences and Acritas.

Experience

  • Inmarsat and Ofcom prevail in appeal regarding Inmarsat's European Aviation NetworkJones Day represented Inmarsat Ventures Limited as intervener in a UK appeal by Viasat UK Ltd of The Office of Communication's ("Ofcom") decision to authorize Inmarsat to use complementary ground components as part of its European Aviation Network providing in-flight mobile communication services.
  • Sumitomo Dainippon Pharma acquires late stage biopharma companies and forms alliance with Roivant Sciences Ltd. worth $3 billionJones Day advised Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo") in an acquisition of late stage biopharma companies and formation of alliance with Roivant Sciences Ltd.
  • Shiseido acquires Drunk Elephant™ for $845 millionJones Day advised Shiseido Americas Corporation in its $845 million acquisition of Drunk Elephant™.
  • ICON acquires Symphony Clinical ResearchJones Day advised ICON plc as health care, clinical trial regulatory, and data privacy diligence counsel in its acquisition of Symphony Clinical Research, a leading provider of at-home patient and site support services.
  • Arsenal Capital Partners acquires HistoGeneX and Caprion BiosciencesJones Day advised Arsenal Capital Partners on major investments in HistoGeneX and Caprion Biosciences and the subsequent combination of the two businesses.
  • Evidera acquires MedimixJones Day advised Evidera, a business unit of Pharmaceutical Product Development, LLC, in its acquisition of Medimix International, a global technology company providing real-world evidence (RWE) insights and information to the pharmaceutical, diagnostic, and medical device industries.
  • UPL acquires Arysta LifeScience from Platform Specialty Products Corporation for $4.2 billionJones Day advised UPL Limited ("UPL"), a leading global generic agrochemical company based in India, in connection with its subsidiary, UPL Corporation Limited’s, US$4.2 billion acquisition and related $3 billion term financing of Arysta Lifescience Inc. (“Arysta”), a global provider of crop protection solutions, including bio-solutions and seed treatment, from NYSE listed Platform Specialty Products Corporation (“Platform”).
  • International pharmaceutical company builds anti-corruption compliance programJones Day has been retained by an international pharmaceutical company to conduct anti-corruption and anti-bribery risk assessments for over 35 countries.
  • Major manufacturer of fashion glasses responds to regulatory investigations and negotiates fine reductionJones Day successfully assisted a major international manufacturer of fashion glasses in responding to regulatory investigations and negotiating undertakings and fine reduction with the competent Italian authority.
  • CVC Capital Partners acquires Teva's International Women's Health assets for $703 millionJones Day advised CVC Capital Partners in its $703 million acquisition of Teva Pharmaceutical Industries Ltd's International (non-US), Women's Health assets.
  • Koch Disruptive Technologies leads $150 million investment in INSIGHTECJones Day advised Koch Disruptive Technologies, a subsidiary of Koch Industries, Inc. focused on finding and funding innovative and emerging companies, as the lead investor in a $150 million Series E funding round for INSIGHTEC, a commercial stage medical device company.
  • Pharmaceutical company seeks advice on regulatory reporting obligationsJones Day counsels a major pharmaceutical company in connection with regulatory reporting obligations in more than 40 countries regarding diverted, counterfeited, tampered with, or lost or stolen pharmaceutical product.
  • Athersys completes $23 million public offering of Common StockJones Day represented Athersys, Inc., an international biotechnology company developing novel and proprietary best-in-class therapies designed to extend and enhance the quality of human life, in connection with its public offering of 22,772,300 shares of Common Stock.
  • GE Healthcare acquires RapidscanJones Day advised GE Healthcare in connection with its acquisition of Rapidscan Pharma Solutions, Inc., which is a single product pharmaceutical company with the exclusive rights to produce and sell the pharmacological stress agent Rapiscan® (regadenoson) in territories outside of North America.
  • Shiseido Americas acquires Gurwitch ProductsJones Day advised Shiseido Americas Corporation ("Shiseido Americas"), a subsidiary of Shiseido Co., Ltd. (Tokyo Stock Exchange, First Section: 4911), a leading global cosmetics company, in connection with the acquisition of Gurwitch Products, LLC ("Gurwitch") from Alticor, Inc.
  • BioMarin acquires global rights to Phenylketonuria (PKU) franchise from Merck Serono for $588.8 millionJones Day advised BioMarin Pharmaceutical Inc. in connection with its €525 million ($588.8 million) acquisition of the global rights to Kuvan® (sapropterin dihydrochloride) and pegvaliase from Merck Serono.
  • XIO acquires Lumenis for approximately $510 million, $14 per share, in cashJones Day advised XIO Group in its acquisition of Lumenis Ltd., the world's largest energy-based medical company for surgical, ophthalmology, and aesthetic applications, for $14 per share in cash, for an aggregate purchase price of approximately $510 million.
  • Abbott purchases option to acquire Cephea Valve TechnologiesJones Day advised Abbott Laboratories in the providing of capital and securing of an option to purchase Cephea Valve Technologies, a private company developing a catheter-based mitral valve replacement therapy.
  • Cellectis completes $228 million IPOJones Day represented Cellectis SA, a French biotechnology company that develops novel cancer treatments, in connection with its $228 million initial public offering in the United States and Nasdaq listing.

    • The following represents experience acquired prior to joining Jones Day.

    Advised a pharma and medical device manufacturer in connection with product liability claims associated with participation in a clinical trial in Europe.

    Coauthored a report, on behalf of the Kuwaiti government, on the legal implications of the creation of a high-technology hub, addressing issues such as cybersecurity laws and biotechnology regulation.

    Advised a fashion giant in the sale and marketing of cosmeto-textile products on a pan-European basis.

    Led a global due diligence exercise in connection with the successful US$800 million sale of the diagnostic business of a major Japan-based medical device manufacturer.

    Advised a major satellite operator in the successful bid to obtain frequencies for the operation of mobile satellite services in the first ever EU-wide award procedure launched by the European Commission.

    Acted as strategic and regulatory counsel to one of the world's leading clinics in connection with the internationalization of its activities in Europe.

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    October 2020 Newsletters

    Vital Signs: Digital Health Law Update | Fall 2020

    October 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 25

    October 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 24

    October 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 23

    September 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 22

    September 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 21

    September 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 20

    August 2020 Alerts

    New French Anti-Gift Regime Finally Adopted for the Health Sector

    July 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 19

    July 2020 Newsletters

    COVID-19 Key EU Developments, Policy & Regulatory Update No. 18
    View All

    Speaking Engagements

    • September 15-17 & 23-24 2020
      13th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker, Cambridge United Kingdom
    • September 9-12, 2019
      12th Annual European Pharma Law Academy, Pharmaceutical Law, Downing College, Cambridge University, Speaker, Cambridge United Kingdom
    • June 18, 2019
      Annual Life Sciences Seminar, Speaker, EU Regulations
    • September 26, 2018
      Annual Congress of the Dutch Clinical Research Foundation (keynote speaker)
    • September 10-13, 2018
      11th Annual European Pharma Law Academy – Pharmaceutical Law Downing College, Cambridge University
    • June 19-20, 2018
      Women Leaders in Life Sciences Law "Recognizing Your Own Leadership Style and Learning How to Be Perceived as a Leader"
    • March 6-7, 2018
      CBI’s EU Clinical Trial Regulation Summit: CTR, MTR and GDPR – The Big Bang of New EU Regulations Impacting The EU Clinical Regulatory Landscape
    • November 28-29, 2017
      EU Clinical Trial Regulation, speaker, Informa's Clinical Trial Supply
    • March 14-15, 2017
      New personal data protection regulation in the EU and potential applications to the plasma collection, speaker, International Plasma Protein Congress 2017
    • November 9, 2016
      Jones Day Global Life Sciences Conference – 2016 Issues & Trends
    • June 9, 2016
      Transparency in the Pharmaceutical Sector, Pharmaceutical Contract Management Group Annual Conference, Speaker
    • March 30, 2016
      Pharmacon China, "Driving Resilient Partnerships for Growth", Speaker
    • March 22-23, 2016
      International Plasma Protein Congress, speaker
    • February 2, 2016
      "Conflict resolution", Pharmaceutical Contract Management Group, Speaker
    • September 17, 2015
      “Sunshine Act”, “Doctor-Initiated Clinical Study” and“Off-label Promotion and FCA claims”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Speaker
    • September 9, 2015
      “M&A in Life Sciences”, Annual Conference of China’s Private Equity Association, Speaker
    • June 15, 2015
      Plasma Protein Forum, Speaker
    • June 10, 2015
      Advertising and Food Products - Which Rules and Which Trends in Europe? - The European Rules of Food Communication, Speaker
    • April 22, 2015
      Pharmaceuticals Regulatory Developments Including New Clinical Trials Legislation, Women Leaders in EU Life Sciences Law, Speaker
    • March 4, 2015
      Negotiating an Effective Clinical Trial Agreement and Limiting Litigation Exposure, ABA Life Sciences Legal Summit, Speaker
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