LIFE SCIENCES LAW
We advise on legal issues relating to the Pharmaceuticals, Biotechnology and Biopharmaceuticals industries, Clinical Research Organisations and the specialist wholesale distribution of medicines.
Our Specialisms Include:
Employment Contract Support
- Intellectual Property licensing of pharmaceuticals, including in-licences from, and out-licences to, third parties.
- Distribution agreements for pharmaceutical products in the UK, EU and globally.
- Terms and conditions of purchase and sale of medical products and items used for manufacturing and research purposes.
- Clinical Trial Agreements between pharmaceutical companies and Clinical Research Organisations.
- ABPI Code of Practice for the promotion of medicines; making claims against, and defending claims from, other pharmaceutical companies alleging breach of the ABPI Code which is administered by the Prescription Medicines Code of Practice Authority.
- Data privacy and GDPR including the anonymisation/pseudonymisation of patient personal data in clinical trials, the holding of personal data on medical practitioners and also the transfer of personal data outside the UK/EEA, and to the US in particular, following the Clarifying Lawful Overseas Act 2018 (CLOUD Act) and the foreign Intelligence Surveillance Act (FISA) in the US, the Schrems II case in the ECJ, the EU’s Standard Contractual Clauses, and the ICO’s UK addendum to the SCCs.
- Contract-manufacturing agreements and templates
- Regulatory matters involving the MHRA in respect of medicines and medical devices.
- Research and collaboration agreements with third parties, including universities and other research organisations.
Advisory Services
- Company start-up, acquisition, restructuring, and due diligence obligations
- Change of management, including the planning and implementation of collective redundancies
- Redundancies, disciplinary and grievance matters
- Training, and updates on employment rights
- Flexible working
- Creation and drafting of bonus schemes, pension obligations and share incentives
- Employment issues relating to corporate acquisitions and disposals
- Changing terms and conditions
- Negotiation of collective agreements
- Corporate compliance issues regarding data protection legislation, and
- Other data protection issues including the monitoring of company e-mails and internet usage, and subject access requests.
Dispute Resolution
- Discrimination and whistleblowing claims
- Actions for breach of contract
- Boardroom disputes
- Enforcement of restraints and confidentiality protection
- Whole team moves, and
- Collective disputes
