Regulations in life sciences
Mercure Avocats has developed expertise in regulations in life sciences, in the health, cosmetics, food products and associated technology sectors, and in particular with respect to the following aspects:
- Research and development of health products, clinical trials and other types of studies
- Placing them on the market, including obtaining regulatory approvals and other obligations to be satisfied with regard to the authorities
- Product manufacture and distribution
- Advertising
- Relationships with healthcare professionals
- Online health initiatives (“e-health”)
- Data protection in the healthcare field
- Transparency / compliance
Complex / strategic contracts
We assist our clients in preparing and negotiating all types of contracts specific to the healthcare sector:
- R&D agreements, license agreements / license options, partnerships, sponsorships
- Service agreements
CRO, clinical trials, other types of studies - Manufacturing agreements
- Distribution contracts
- Commercial agreements
e.g., communication agencies, marketing - Contracts with healthcare professionals
Private equity and M&A
We also support our clients in implementing their most complex / strategic projects regarding their financing and external growth operations:
- Venture capital
- Capital investment
- Incentive schemes / management package
- Mergers and acquisitions
Work on innovative projects
We have a strong expertise in supporting structuring of the most innovative projects, taking heed of both the regulatory and business requirements:
- Innovative projects’ structuration
e.g. medical centres, healthcare institutions - Health products / innovative manufacturing process of products
Examples of projects on which we have worked on
Regulations in life sciences
- Support of legal departments of several reputed pharmaceutical companies and medical device manufacturers, both for the day-to-day operations (contracts review, analyses related to regulatory aspects of the health sector and issues concerning pharmaceutical law and healthcare products and medical devices : clinical studies, « anti-gifts » regulations, transparency obligations, data protection, advertising, etc.) and specific operations (e.g. negotiating complex / strategic contracts, such as partnerships / license agreements, etc.)
- Support of several companies in the field of data protection and data transfer
- Support of a French pharmaceutical company within the scope of its external growth project in Europe and in the United States
- Realization, for a medical device manufacturer, of multi-country information sheets regarding the « anti-gift » regulations and transparency obligations applying abroad, in several jurisdictions
Complex / strategic contracts
- Negotiation of an exclusive license agreement and an exclusive distribution contract between two pharmaceutical companies (a French and an American)
- Negotiation of a partnership between a French biotech and an American pharmaceutical company
- Support of a listed biotech within the scope of the implementation of a clinical study abroad (negotiation of contractual arrangements with the CRO (contract research organization) and with the local partners)
- Support of a medical device manufacturer within the scope of the negotiation of a development and manufacturing contract of its innovative medical device
Private equity / M&A
- Assistance of an investment fund in the context of the acquisition of a firm specialized in animal food products
- Support of several start-ups in the biotech / medtech sectors, in the context of fund raising operations
- Implementation of incentive schemes for directors of start-ups in biotech / medtech sectors
- Acquisition, by an Indian pharmaceutical group, of a French pharmaceutical company
- Intervention, in partnership with leading law firms, on the regulatory aspects of M&A, IPO, structuration of complex projects.
Structuration of innovative projects
- Support of investors in the structuration and creation of innovative healthcare dedicated centres
- Realization of a legal and regulatory feasibility analysis, for a project manager, relating to an innovative manufacturing process of medical devices
- Realization of a feasibility analysis relating to the creation of a healthcare centre dedicated to language disorders
- Realization of a structuration analysis in connexion with the implementation of a e-heath platform