Practice Areas
Licensing & IP
In-licensing and out-licensing are the primary vehicles for portfolio building in biotech. The deal structure (exclusivity, field of use, royalty benchmarks, option timing) depends on the stage of development, the patent landscape, and the anticipated commercial pathway. License structures that don't anticipate timeline shifts create disputes years later, when commercialization pathways diverge from initial assumptions.
- Exclusive and non-exclusive license agreements
- Option agreements with milestone gates
- Royalty structures and benchmarking
- Field-of-use and territorial restrictions
Research Collaborations
Sponsored research, CRO partnerships, and academic collaborations require careful IP allocation and publication frameworks. Research assets created upstream (compounds, data, know-how) must flow downstream to commercial development without encumbrance.
- Collaboration agreements with milestone structures
- Sponsored research agreements
- Material transfer agreements
- Consortium agreements with multi-party governance
Clinical Development
Clinical contracts span multiple jurisdictions and regulatory systems, from the EU CTR and ICH-GCP to Swiss KlinV. Each agreement (with CROs, investigators, and trial sites) must support both the regulatory submission strategy and the broader commercial development timeline.
- Clinical trial agreements
- CRO master services agreements
- Investigator and site contracts
- Manufacturing and supply agreements (CMO/CDMO)
Getting Started
Most engagements begin with a scoping call to define the matter, regulatory context, and timeline. From there, the engagement is structured (hourly, project-based, or retainer) to fit the scope and existing internal processes.
For companies needing ongoing support without a full-time hire, fractional counsel arrangements provide continuity across the contract portfolio and regulatory landscape.
Biotech and pharma matters are handled through these engagement formats: