Fix the commercial terms that break once the product reaches the market.

Who this is for

Pharmaceutical, biotechnology, medical-device and health-product companies

Typically instructed by: Regional and country legal counsel · legal business partners · market access · commercial

Scope

What can be instructed

Distribution and supply

Distribution, supply, agency and wholesale arrangements, including territory, exclusivity, forecasting and termination.

Licensing

In-licensing and out-licensing, field and territory definition, sublicensing and royalty mechanics.

Quality and pharmacovigilance

Quality agreements and pharmacovigilance agreements, and their alignment with the underlying commercial contract.

Product liability and recalls

Liability allocation, recall responsibility and cost-bearing, and the interaction with insurance.

Local representation structures

The South African contracting entity, the party holding the marketing authorisation, and the documented allocation of regulatory responsibility.

Commercial effect of regulatory requirements

How registration, licensing and labelling requirements bear on pricing, supply commitments and launch sequencing in the contract.

Before you instruct

What helps the firm assess the matter

• The counterparties and any related entities, for the conflicts check.
• The product or portfolio, and its South African registration status if relevant.
• Whether a global template governs, and which terms are negotiable.
• The commercial deadline the arrangement is working to.