Batch Failure. Supplier agrees to notify Customer as soon as reasonably possible, but in any event within five (5) business days of discovery of any batch failure that could result in Supplier’s inability to meet Customer’s requested delivery dates, or of learning of any failure of any batch of API manufactured for delivery to Customer to meet standards set forth in the Specifications or warranties herein.
Batch Failure. Impax agrees to notify Schering within thirty-six (36) hours of discovery after any batch failure which could result in Impax's inability to meet Schering's requested delivery dates, or of learning of any failure of any batch of Product to meet standards set forth in the Impax Know-How. Impax shall notify Schering within thirty-six (36) hours after any failure of a released batch during stability testing. Impax shall complete out-of-specification investigations within thirty (30) calendar days from date of discovery.
Batch Failure. If Precision is unable to achieve Phase II Ready Batch Success within [***] after the date of the Commercial Option Exercise Notice with respect to a Licensed Product Candidate, then the JSC shall meet to consider (a) whether Phase II Ready Batch Success can be achieved, (b) whether it is commercially reasonable to continue to seek to achieve Phase II Ready Batch Success and, (c) upon positive determination of (a) and (b), to develop a plan for such achievement (the “Batch Success Achievement Plan”). Following receipt of the Batch Success Achievement Plan from the JSC, Precision will use Commercially Reasonable Efforts to perform the activities set forth in such plan as promptly as practicable. If, subsequent to the performance of the activities set forth in the Batch Success Achievement Plan, Phase II Ready Batch Success has not been achieved, the JSC shall meet to discuss the considerations set forth in clauses (a) through (c) above, and any further obligations of Precision in relation to manufacturing and quality testing of the Phase II Ready Batch shall be subject to the JSC’s approval of an additional Batch Success Achievement Plan.
Batch Failure. Pursuant to Section 5.8.3 of the MSA, the Parties shall be responsible for costs related to Batch Failure as follows:
Batch Failure. 14 7.8 Notification of Inspections................................. 15 7.9
Batch Failure. Genchem Pharma agrees to cause Sicor to notify Anthra within two (2) working days of discovery of any batch failure which could result in Sicor's inability to meet Anthra's requested delivery dates, or of learning of any failure of any batch of AD32 manufactured by Sicor for delivery to Anthra to meet standards set forth in the Manufacturing Know-how or the Specifications.
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. 6.1.12
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. After completion of the ***subject to Section 7.4, if during a calendar year Bacthera fails to deliver more than [***] if the cause of the defect was that (i) the SRM contained latent defects that were not reasonably detectable by Bacthera upon receipt thereof or (ii) the root cause of the failure is deemed to be the analytical method itself, which was executed by Seres. [***].
Batch Failure. GalaGen agrees to notify Wyeth-Ayerst within one (1) working days of discovery of any Batch failure which could result in GalaGen's inability to meet Wyeth-Ayerst's requested delivery dates.
