Naomi Leach

Partner

Naomi is a highly regarded partner in our life sciences team with a transactional IP, data protection and commercial practice.  Her work focuses on life sciences transactions that span the lifecycle of a pharmaceutical product.

Her experience ranges from negotiating early-stage research, collaboration and licensing agreements through to those agreements required following the commercialisation and launch of a pharmaceutical product, such as complex distribution and manufacturing arrangements.  Her experience also includes providing intellectual property, IT and data protection input into M&A transactions within the life sciences industry.

Naomi’s life sciences experience includes advising:

  • BTG plc in relation to its exclusive out-licensing agreement with Carrick Therapeutics Ltd for the development and commercialisation of “BTG945” a targeted ovarian cancer drug; and its compliance with the General Data Protection Regulation (GDPR) including its internal and external policy documents and advice in relation to managing compliance with the GDPR in the context of Clinical Trials and informed consent forms.
  • An international pharmaceutical company on a strategically important collaboration agreement with Verily LLC (the life sciences arm of Alphabet) in relation to the use of a wearable technology in the context of a Phase 2 clinical trial.
  • Shield Therapeutics plc in relation to its strategically important exclusive licensing agreement with Norgine B.V for the rights to commercialise Shield's "Ferracru" product across Europe and follow up manufacturing arrangements.
  • Kymab Limited in relation to a number of research and licensing collaborations with respect to its "Kymouse" human antibody model.
  • Gilead Sciences Europe Limited in relation to a Talent Acquisition Outsourcing Agreement and in relation to its Clinical Trial Agreements and the impact of Brexit on the appointment of a UK Legal Representative under the Clinical Trials Directive.
  • Otsuka Pharmaceuticals Europe Limited in relation to a suite of documents including a Master Services Agreement (including Market Research), Sponsorship Agreement, and HCO/HCP Agreements.
  • Astellas Pharma Europe Limited on a wide range of matters including in relation to IT infrastructure, distribution agreements, master agreements for the provision of marketing and regulatory affairs services and data protection.  Naomi also spent time on secondment at Astellas.
  • Piramal Enterprises Limited, in relation to IP matters, on the sale of Piramal Imaging SA to UK based medical imaging services provider Alliance Medical Group, part of the Life Healthcare Group.

Expertise