CASE STUDIES

I support clients with a wide range of matters, ranging from high-value and high-impact transactions to day-to-day transactional legal support. 

Some examples include:

• Negotiation of a research collaboration with the option to licence with a value of $350 million between a Biotherapeutic company (my client) and a global Pharmaceutical Company.

• Advised stealth-mode Biotechnology companies on academic collaborations with focus on IP protection.

• Created and implemented a global outsourcing template suite for a Japanese Pharmaceutical Company, including a  global use Clinical Master Services Agreement (inclusive of CMC and Phase I provisions) with a top-5 Clinical Research Organisation, subsequently negotiated face-to-face in an auditorium setting in Tokyo. Delivered internal contractual training to Japanese colleagues and introduced 'rough-guides' to support project teams.

• Global research and development programmes, including development and negotiation of global clinical trial agreement suites, including data privacy, regulatory and ancillary agreements. Site-level reviews and negotiations for both Clinical Research Organisations and multiple sponsor Pharmaceutical companies.

• Establishment of a global healthcare engagement & transparency programme for a Japanese Pharmaceutical Company at the time of the introduction of transparency requirements by EFPIA & IFPMA. 

• Creation of central template suites, policies, SOPs, workflows and guidance for use by scale-up and mid-size Pharmaceutical companies to compliantly engage Healthcare Professionals (HCPs, HCO, POs, MoPs), including legal review of promotional materials and negotiation of individual agreements. Advice on SharePoint design to assist with collation and reporting of annual transfers of value on a global basis.

• Drafting and negotiation of high-value GMP/regulated Manufacturing and Supply Agreements (including templates) across multiple life sciences organisations, including Pharmaceutical, FSMP and FMCG.

• Advised Medical Devices company on Wholesale Distribution Agreements and App development collaboration with NHS, including data privacy advice.

• Legacy data privacy compliance deep-dives and corrective action plans, including mapping, policies, procedures, infrastructure and templates for multiple start-ups and scale-up Pharmaceutical Companies, a Clinical Research Organisation and a global GMP cosmetics manufacturer.

• Selection, onboarding and management of IT Service Provider for start-up Pharmaceutical Company and design/implementation of SharePoint infrastructure in a global environment.

• Led internal investigations and managed external counsel in contractual disputes, including settlement with substantial damages in a claim resulting from a GMP breach by a manufacturer and minimisation of financial exposure in conflict relating to failure to meet timelines and escalating third-party costs.

• Led internal in-depth investigation and management of external counsel in defence of strict liability corporate criminal offence resulting in a minimal fine.

• Establishment of first in-house legal functions in multiple organisations, ranging from start-ups to global companies with turnover of approximately CHF 650 million.