Storage and Shipping. Following release, each Order shall be held for -------------------- AASTROM by IMMUNEX in secure storage for use by or shipment to AASTROM or to such other recipient as instructed by AASTROM. All Orders shall be shipped FOB IMMUNEX's United States facility to a location in the Territory as designated by AASTROM with the insurance paid by IMMUNEX. AASTROM shall be responsible for all shipping charges, which shall be itemized on each invoice by IMMUNEX. Title to and risk of loss for each Order shall transfer to AASTROM upon delivery to AASTROM's designated delivery location. AASTROM shall provide IMMUNEX with a specific list of approved carriers that meet AASTROM's specifications for handling during shipment. AASTROM shall be solely responsible for any reshipments of Supplied Products or any shipments of Supplied Products outside the Territory.
Storage and Shipping. 4.1 Up to the delivery of Product to GSK's carrier, ALLERGAN will ensure Materials and Product are shipped and stored such that the environmental conditions are maintained, monitored and recorded as appropriate to meet the conditions specified on the label, cGMP and any other regulatory requirements.
4.2 From and after the delivery of Product to GSK's carrier, GSK will ensure Product is shipped and stored such that the environmental conditions are maintained, monitored and recorded as appropriate to meet the conditions specified on the label, cGMP and any other regulatory requirements.
Storage and Shipping. 34 8. Stability Testing and Sample Retention................... 35 9. Lot Recall............................................... 36 10.
Storage and Shipping. All materials, components, Products, work in progress and related items shall be stored and shipped per environmental requirements specified in Product Specifications or raw material and component specifications.
Storage and Shipping. Seller will ensure that during packaging, storage and shipment of the Products that there is no possibility of deterioration, contamination or admixture with any other materials. Seller will only ship goods to Purchaser’s designated locations.
Storage and Shipping. “Buyer shall provide purchase orders setting forth a quantity of Products which Buyer requires from Seller and Buyer’s delivery requirements. Buyer shall issue purchase orders for delivery of Products at its discretion. In order to assist Buyer in controlling its inventory, Seller shall provide suitable storage and warehousing space for all Products for the time and to the extent required by Buyer, including storage of all Products for up to thirty (30) days after the originally scheduled shipping date set forth in the applicable purchase order. No additional charges for such storage and warehousing of Products will be paid charged to Buyer. If Buyer requires Seller to provide storage for any Products for a period longer than thirty (30) days after the originally scheduled shipping date set forth in the applicable purchase order for the Products, then Buyer shall in addition pay Seller a reasonable charge for such longer storage requirements. All Products will be stored in clean space suitable for storage of food and protection of its contents with respect to integrity and quality, in compliance with good commercial practice and all applicable laws, rules and regulations, including, without limitation, FDCA regulations.
Storage and Shipping. MPL final product is filled and lyophilized in 1 L screw top bottles composed of USP Type 1 borosilicate uncolored glass. The fill quantity is 2 g per bottle and the bottles are stoppered under a nitrogen gas overlay. The bottles are closed with 43 mm lyophilization stoppers made of gray butyl rubber (4416/60 gray formulation). Bottles plus stoppers are capped with plastic screw caps and are sealed with tamper-proof seals. MPL is also provided in 10 mL vials with 5 mg per vial for Quality Control testing at Corixa and GSKBio. The vials are made of USP Type 1 borosilicate uncolored glass and are closed with 20 mm lyophilization stoppers consisting of gray butyl rubber (formulation 850). Vials plus stoppers are capped with 20 mm aluminum tear-off seals. A shipment of MPL is initiated with receipt of a purchase order from GSKBio and is based upon availability of inventory as well as prior agreements between GSKBio and Corixa. MPL is delivered to GSKBio FOB from the Corixa facility in Hamilton, MT, or at other locations as Corixa may specify. Title to and risk for the MPL shipment passes to GSKBio upon delivery to the freight carrier. Shipments of MPL are handled by Federal Express International carrier or equivalent and will be designated as "international priority" mail. All shipping procedures for MPL are described and controlled in SOPs (see Section 3). The specified shipping containers hold up to 6 x 2 g bottles of MPL,. The bottles are wrapped individually with protective packing material prior to placement in the container. Frozen ice packs are included with each shipping container to maintain a specified temperature range throughout the course of the shipment. Corixa will use validated shipping configurations to guarantee the temperature and seal of the materials during their transfer to GSK-premises. Depending on the quantity of MPL that has been ordered, a shipment may comprise more than one shipping container and more than one lot of MPL. The container designated as "#1 of N" will contain the following items:
1. For each lot of MPL in the shipment, a Release Protocol that provides testing results and release authorization by the Quality Assurance Manager (Appendix 2);
2. For each lot of MPL in the shipment, a Tracking Transfer Document that contains a deviation summary, as well as a summary of any manufacturing changes, information on lot numbers, yields, and test results for the in-process intermediates used in manufacture of the lot, along with pr...
Storage and Shipping. 1Halo must ensure that during manufacturing, packaging, processing, and storage of the Product there is little possibility of deterioration, contamination or mixing with any other materials and must comply with all applicable GMP requirements in relation to required temperatures and conditions for storage.
Storage and Shipping. 13.1 Storage JB Labs will ensure that during storage of the Product(s) that there is no possibility of deterioration, interference, theft, Product contamination or admixture with any other materials. Xanodyne Corporate Quality Assurance will provide details of any labeling requirements and container sealing and integrity requirements.
Storage and Shipping. (a) During the Transitional Products Shipment Period, Supplier will store Products at existing Supplier plants and distribution centers. Supplier will be responsible for all damages to or loss of Products that take place while Products are stored in Supplier controlled distribution centers.
(b) After the Transitional Products Shipment Period, Supplier will ship, or arrange for a Contract Manufacturer to ship, Products in full truckload quantities (on common carriers selected by Buyer) at Buyer's expense (including without limitation any duties payable in respect of any shipment) and risk of loss from the Plant or Contract Manufacturer's facility (i.e., F.O.B. Supplier Plant or F.O.B. Contract Manufacturer's facility) to 5 locations specified by Buyer in writing at least 15 calendar days prior to Supplier's first shipment. Upon 30 calendar days prior notice to Supplier, Buyer may change any destination for shipment of Products from the Plant or any Contract Manufacturer's facility. Neither Supplier nor any Contract Manufacturer will be responsible for month-month storage of finished product inventory, it being anticipated that all Product Manufactured will be shipped pursuant to Buyer's Forecast for each month.
