Modifications in API. Customer shall notify Encap of any change related to the API that would affect the validated process including but not limited to supplier changes, process change, regulatory change, and environment health safety characteristics. To the extent practicable, Customer should provide to Encap a written notification of such change at least [***] days before implementation of the change. In the case that the change warrants validation batches, the costs associated will be borne by the Customer.
Appears in 2 contracts
Sources: Commercial Manufacturing Services and Supply Agreement, Commercial Manufacturing Services and Supply Agreement (Lipocine Inc.)