Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.
Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.
API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.
Defective Product If Client rejects Products under Section 6.1 and the deviation is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Products. If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Products; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2.
Purchase Orders Contemporaneously with its delivery of a Forecast, Prometheus shall deliver to GSK a purchase order (each, a "Purchase Order") for any Product volumes in such Firm Zone for which Purchase Orders have not already been submitted in prior months, and such Product volumes shall be equivalent to full increments of GSK's standard batch size for each Product as per Schedule 3.1. Each Purchase Order shall specify the volumes of Products ordered, and the Delivery Date the Product is to be made available to Prometheus for pick-up by Prometheus' designated carrier or freight forwarder. Purchase Orders may be delivered electronically or by other means to such location as GSK shall reasonably designate. Prometheus shall issue each Purchase Order to GSK not less than one hundred twenty (120) days prior to (i) the Delivery Date on which Prometheus has requested GSK to deliver Product pursuant to each such Purchase Order, and (ii) the termination of this Agreement pursuant to Section 14.2(a) or the expiration of the Term. Provided that the Product volumes conform to the Firm Zone volumes under Section 2.2 and requested Delivery Dates on any Purchase Order conform to the requirements of the immediately preceding sentence, GSK will review and accept such Purchase Order within five (5) Business Days after receipt thereof. If Product volumes or requested Delivery Dates on any Purchase Order do not so conform in any respect, then such Purchase Order shall be reviewed and handled by the parties in accordance with Section 2.4. In the absence of the receipt by GSK of a Purchase Order for any volumes in the Firm Zone, the volumes forecast in such Firm Zone shall constitute a binding Prometheus Purchase Order. Purchase Order quantities Delivered by GSK may vary by ± [***] percent ([***]%) from the quantities ordered. Such variances shall not constitute a breach of contract by GSK, provided that Prometheus shall only be obligated to pay for the amount of invoiced Product actually received, subject to Sections 6.2 and 6.3. Notwithstanding anything to the contrary herein, following the date on which Prometheus has received the required Regulatory Authority Consents to manufacture the Products at its own facility, or at a Third Party facility as described in Section 4.6, Prometheus may elect to no longer submit Forecasts or Purchase Orders under Sections 2.2 and 2.3 provided that Prometheus shall notify GSK in writing that it will no longer submit Forecasts and/or Purchase Orders. If Prometheus provides such notice, then GSK shall only be obligated to accept any Purchase Orders that conform with the last monthly Forecast and such corresponding Firm Zone submitted by Prometheus prior to such notice. For the avoidance of doubt, Prometheus may continue to submit monthly Forecasts per Section 2.2 (even if Prometheus already has received the required Regulatory Authority Consents for manufacture as described in Section 4.6) and the Parties' obligations to submit and accept Purchase Orders shall continue to be governed by Sections 2.3 and 2.4 during the Term and subject to conditions per Section 4.4(a) and 14.2(b). *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.
Product Returns Client will have the responsibility for handling customer returns of the Products. Patheon will give Client any assistance that Client may reasonably require to handle the returns.
Supplier Selection If Customer selects a seat or galley supplier that is not on the Boeing recommended list, such seat or galley will become BFE and the provisions of Exhibit A, Buyer Furnished Equipment Provisions Document, of the AGTA will apply.
Defective Products None of the Group Companies has manufactured, sold or supplied products which are, or were, in any material respect, faulty or defective, or which do not comply in any material respect with any representations or warranties expressly made by such Group Company, or with all applicable regulations, standards and requirements.
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