Life Sciences companies frequently fail to enter formal contractual agreements with their suppliers, and instead rely on insufficient purchase orders or contracts that don’t provide enough detail.
Here are some pitfalls:
i) Purchase orders are one-sided and typically don’t require the supplier to indemnify or carry appropriate insurance.
ii) Is recall addressed?
iii) Who really designed your product? Is this properly documented in your contract? In other words, whose product is it and who could be liable in the event of an injury?
iv) Is your foreign supplier required to purchase a US based Products Liability insurance policy, i.e. defensible and collectible in the USA?
v) Does your contract spell out how you will audit your supplier?
vi) Does your contract spell out who is responsible for fulfilling FDA regulatory requirements?
Contact us here for more information.
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