Common use of Batch Failure Clause in Contracts

Batch Failure. Vendor agrees to notify Keryx promptly (but in no event more than [***]) of discovery after any Batch failure which could result in Vendor’s inability to meet Keryx’s requested delivery dates, or of learning of any failure of any Batch of Product to meet Specifications or the manufacturing requirements or if Vendor has any other safety or efficacy concerns with respect to a Batch of Product. Vendor agrees not to reprocess or rework any Batch of Product, or any intermediate in the manufacture of Product, without the prior written approval of Keryx in writing (in its sole discretion). Vendor shall notify Keryx promptly (but in no event more than [***]) after any failure of a released Batch during stability testing.

Appears in 2 contracts

Sources: Master Manufacturing Services and Supply Agreement, Master Manufacturing Services and Supply Agreement (Keryx Biopharmaceuticals Inc)