Common use of Batch Failure Clause in Contracts

Batch Failure. BioVectra agrees to notify Keryx within [**] of discovery after any Batch failure which could result in BioVectra’s inability to meet the agreed upon delivery dates, or of learning of any failure of any Batch of Product to meet Specifications or the Manufacturing Requirements, or if BioVectra has any other safety or efficacy concerns with respect to a Batch of Product. BioVectra agrees not to Reprocess any Batch of Product, or any intermediate in the Manufacture of Product, without the prior written approval of Keryx in writing (in Keryx’s sole discretion). Should Keryx provide such approval, BioVectra will Reprocess the affected Batch(es) or intermediate(s) in the Manufacture of Product at its own cost. BioVectra will schedule any Reprocess as soon as practicable.

Batch Failure. BioVectra agrees to notify Keryx within [***] of discovery after any Batch failure which could result in BioVectra’s inability to meet the agreed upon delivery dates, or of learning of any failure of any Batch of Product to meet Specifications or the Manufacturing Requirements, Requirements or if BioVectra has any other safety or efficacy concerns with respect to a Batch of Product. BioVectra agrees not to Reprocess or Rework any Batch of Product, or any intermediate in the Manufacture manufacture of Product, without the prior written approval of Keryx in writing (in Keryx’s its sole discretion). Should Keryx provide such approval, BioVectra will Reprocess or Rework the affected Batch(es) or intermediate(s) in the Manufacture manufacture of Product at its own cost. BioVectra will schedule any Reprocess or Rework as soon as practicabledetermined by BioVectra, according to its most efficient manufacturing schedule.