Sharmela Kalmer Partner

Sharmela Kalmer

Sharmela is a trusted advisor to a number of emerging and established innovative technology and life sciences companies operating in a range of sectors, including biotech, medtech, foodtech and agritech. She has healthcare industry experience having worked in-house at Sanofi, Virgin Care Limited and Takeda Pharmaceuticals. Sharmela is also a member of the West London & GTAC (Gene Therapy Advisory Committee) NHS Research Ethics Committee and is involved in the ethical review of research involving cutting-edge technologies.

Clients in the technology and life sciences sectors have varied needs and face an ever-changing legal landscape. Sharmela's sector knowledge and insight has given her a solid understanding of the opportunities and issues faced by clients shaping the future and how to navigate these issues to access new market opportunities. She provides strategic and pragmatic advice across a company's lifecycle, from early development of technologies or medicines through to commercialisation of approved products or services. She has experience negotiating a variety of commercial and IP related contracts from licence, technology transfer and R&D agreements to manufacture and distribution agreements. Sharmela also provides advice on clinical trial-related agreements, interactions with regulatory authorities and compliance with ABPI Code of Conduct and industry best practices.

Experience

• Negotiated an exclusive licence to gene expression technology for a Dutch-based start-up producing lab-based clean meat from a renowned UK university.
• Advised and drafted an exclusive distribution agreement for a UK medical device company for the distribution of an anaesthesia device in North America.
• Negotiated and drafted clinical trial agreements and documents for a UK-based oncology company undertaking trials in 13 countries across Europe and Asia, including investigator agreements, pharmacy agreements, patient consent forms, information sheets and indemnity letters.
• Advised a biotech which focuses on cancer gene therapy on manufacturing agreements, master services agreements, clinical research agreements and data protection.
• Advised a spin-out from a renowned university focused on treatments for auto-immune mediated, inflammatory disease on its patent licence and know-how agreements, material transfer agreements and secondment agreements during its spin-out.
• Advised a leading developer of lateral flow and rapid diagnostic technologies on a distribution agreement of COVID-19 test kits for certain territories in Africa.
• Advised a company providing robotic arm lab automation technology with its collaboration agreement with a NHS university trust.
• Advised a biotech on a co-development agreement with a US multinational pharmaceutical company for the development and approval of a Leukaemia drug. Advice included drafting of development cost, earn-out and net sales milestone provisions.
• Advised a spin-out from a renowned university which develops nanotechnology-based solutions for sustainable agriculture on its foundational licence agreement.