Notice of Failure to Meet Specifications. Each Party shall notify the other Party immediately after the discovery that any lot of Product sold to Purchaser failed to comply with its applicable Specifications at the time of delivery or was not manufactured in accordance with Applicable Laws, including without limitation cGMP. VIVUS will immediately make, at its sole expense, such further internal investigation of any failure to meet these requirements as is reasonable under the circumstances and otherwise consistent with its obligations hereunder and shall use its best efforts to remediate such failure, which shall include the replacement of the quantity of non-conforming Product at no cost to Purchaser, as promptly as reasonably practicable.
Notice of Failure to Meet Specifications. Upon Aventis’ discovery that any batch or lot of Product fails to conform to the applicable Specifications, Aventis will notify Purchaser in writing within five (5) Business Days of such failure to meet the applicable Specifications and of the nature thereof Aventis shall investigate all such failures promptly and determine the cause for the failure and a corrective action to prevent future failures.
Notice of Failure to Meet Specifications. If Supplier discovers that there is a potential that any batch or lot of the Products already delivered to Lannett may fail to conform to the Specifications, then Supplier shall notify Lannett within three (3) Business Day of such determination of failure to meet the Specifications and of the nature thereof in detail, including, but not limited to, supplying Lannett with all investigatory reports, data and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. Supplier shall investigate all such failures promptly, and at its sole expense, cooperate with Lannett in determining the cause for the failure and a corrective action to prevent future failures.
Notice of Failure to Meet Specifications a) PBM shall promptly notify NANOGEN, at least within 72 hours, of the discovery of any batch or lot of Development Products, which has previously been approved in accordance with the procedures set forth herein, which does not meet the Development Product Specifications. PBM shall provide in such notice details concerning the nature of any such failure to meet the Development Product Specifications. PBM shall make, at its sole expense, such further internal investigations of any failure to meet the Development Product Specifications as is appropriate under the circumstances and otherwise consistent with its obligations hereunder. The liability for costs associated with any such batch or lot of Development Product shall be determined in accordance with Section 8.1 below (Claims).
Notice of Failure to Meet Specifications. If ELITE discovers that there is a potential that any batch or lot of the Products already delivered to LANNETT may fail to conform to the Specifications, then ELITE shall notify LANNETT within twenty-four (24) hours (or one (1) business day), of such determination of failure to meet the Specifications and of the nature thereof in detail, including, but not limited to, supplying LANNETT with all investigatory reports, data and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. ELITE shall investigate all such failures promptly, and at its sole expense, cooperate with LANNETT in determining the cause for the failure and a corrective action to prevent future failures.
Notice of Failure to Meet Specifications. Upon Helsinn’s discovery that any batch or lot of API fails to conform to the Specifications, Helsinn will notify Indevus within three (3) Business Days of such failure to meet the Specifications and of the nature thereof in detail, and will supply to Indevus such information related thereto as Indevus may reasonably request, including, but not limited to, all investigatory reports, data, and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. At its expense, Helsinn shall investigate all such failures promptly, and cooperate with Indevus in determining the cause for the failure and a corrective action to prevent future failures.
Notice of Failure to Meet Specifications. If ELITE discovers that there is a potential that any batch or lot of the Products already delivered to LANNETT may fail to conform to the Specifications, then ELITE shall notify LANNETT within twenty-four (24) hours (or one (1) business day), of such determination of failure to meet the Specifications and of the nature thereof in detail, including, but not limited to, supplying LANNETT with all investigatory reports, data and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. ELITE shall investigate all such failures promptly, and at its sole expense, cooperate with LXXXXXX in determining the cause for the failure and a corrective action to prevent future failures. EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Notice of Failure to Meet Specifications. SWI shall notify Purchaser promptly after the discovery that any lot of Product shipped to Purchaser, which had previously been approved in accordance with procedures set forth herein, fails to comply with its applicable Specifications. SWI will make, at its expense, such further internal investigation of any failure to meet the Specifications SWI deems appropriate under the circumstances and otherwise consistent with its obligations hereunder. Should such failure is determined to be a result of a defect in the Compound supplied by Purchaser from MTPC, then Purchaser shall (i) reimburse SWI the costs of such investigation, and the costs of destruction of the Product, if any, (ii) pay the Price of the Product which failed to meet the Specifications due to a defect in the Compound, and (iii) replace the quantity of Compound necessary to manufacture the replacement batch(es) of Product. In the event of a dispute in regards to a defect in the Compound, then Section 6.2(b) shall apply. In the event of a dispute in regards to a defect in the Compound manufactured by Sanofi Chimie under the Commercial Supply Agreement signed on July 24th, 2013, then such agreement shall apply. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Notice of Failure to Meet Specifications. Upon Selamine's or any Selamine Designee's discovery that any batch or lot of [***] fails to conform to the applicable Specifications, Selamine will notify King within [***] of discovery of such failure to meet the applicable Specifications and of the nature thereof in detail, including, but not limited to, supplying King with all investigatory reports, data, and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. Selamine shall investigate all such failures promptly, and at its expense, cooperate with King in determining the cause for the failure and a corrective action to prevent future failures.
Notice of Failure to Meet Specifications. Upon Inyx’s discovery that any batch or lot of Product fails to conform to the applicable Specifications, Inyx will notify King within forty-eight hours of such failure to meet the applicable Specifications and of the nature thereof in detail, including, but not limited to, supplying King with all investigatory reports, data, and communications, out-of-specification reports and data and the results of all outside laboratory testing and conclusions, if any. Inyx shall investigate all such failures promptly, and at its expense, cooperate with King in determining the cause for the failure and a corrective action to prevent future failures.
