Life sciences & healthcare legal cluster: Hub · Dawn raid · VBP · Hospital AR · Exclusive agency · HGR · Trial injury · CRO/CDMO · Device liability · Labeling · SaMD · Patent linkage · License · FDA WL · MDR/IVDR · Internet hospital · Trade secrets · Pharma ads · Device distribution · Sources · Checklist
Audit the grant of exclusivity
- Territory (geographic, hospital tier, online channel) and product SKU list.
- Performance quotas and whether they survive policy price cuts.
- Sole vs exclusive language; reserved house accounts.
- Registration holder / MAH vs distributor roles — distribution guide.
Termination grounds
For cause
Typical: chronic underperformance, diversion, counterfeit adjacency, bribery red flags, insolvency, IP misuse. Build a contemporaneous file—post-hoc justifications look pretextual in arbitration.
For convenience / change-in-law / VBP shock
Many agreements under-specify what happens when tender economics destroy the deal. Negotiate repurchase formulas and transition service before the award letter lands — VBP disputes.
Inventory, tools & installed base
- Count protocol with dual seals; quarantine near-expiry and open boxes.
- Repurchase price: cost, net realisable value, or formula—state tax/fapiao treatment.
- Demo equipment, consignment stock, and hospital loaners.
- Service obligations for already implanted or installed devices (patient safety first).
Non-compete, non-solicit & data
Post-termination non-competes need reasonable scope/time and, where employment-like, compensation logic. Customer data and hospital relationship maps may be trade secrets—see trade secrets & non-compete. Cut system access the day notice is effective.
Damages themes
- Unpaid goods vs lost exclusive profits (harder—needs credible projections).
- Investment reliance: marketing spend, specialised staff, registration support costs.
- Wrongful dual appointment during exclusive term.
- Defamation / unfair competition if parties trash each other in hospital channels.
Anti-corruption off-ramp
If termination follows a compliance investigation, coordinate messaging so “channel cleanup” does not become obstruction or retaliation narratives — dawn raid playbook.
Related
Hospital AR · Disposable device licensing · Hub