TOSITUMOMAB. GSK Canada shall provide to McKesson (or another Third Party contract labeler of Corixa) pre-approved labels, cartons and leaflets for Tositumomab that comply with all applicable laws, rules and regulations in the Territory. Neither McKesson nor Corixa shall have any obligation to inspect or approve such labels, except for any obligations imposed by applicable laws, rules or regulations. At least [*] in advance of each labeling run, GSK Canada shall supply McKesson with the labels, cartons and leaflets required for such run and written instructions that specify the appropriate packaging components for each product configuration to be prepared in such run. GSK Canada shall inform Corixa prior to sending labels, cartons or leaflets to McKesson, and Corixa will promptly pass such information along to McKesson. The minimum batch size for vial labeling Tositumomab for provision to GSK Canada shall be [*] Cold Components, with the exception that, in calendar year 2003, [*] run will be performed on behalf of GSK Canada for [*] Cold Components ordered by GSK Canada for such year, even though such number is less than [*]. During the rest of the term of this Agreement, GSK Canada may request that vial labeling be performed upon batches of less than [*] Cold Components. Such reduced batch size vial labeling runs will be performed only if McKesson agrees to perform such runs and if GSK Canada agrees to [*] Labeled, packaged Tositumomab will be delivered to GSK Canada, in accordance with Section 4.5(a), in the shipping container that was validated by McKesson, on behalf of Corixa, prior to the Effective Date or any mutually agreed substitute for such shipping container. A temperature monitoring device shall be placed inside such shipping container.
Appears in 2 contracts
Samples: License and Supply Agreement (Corixa Corp), License and Supply Agreement (Corixa Corp)
TOSITUMOMAB. GSK Canada shall provide to McKesson (or another Third Party contract labeler of Corixa) pre-approved labels, cartons and leaflets for Tositumomab that comply with all applicable laws, rules and regulations in the Territory. Neither McKesson nor Corixa shall have any obligation to inspect or approve such labels, except for any obligations imposed by applicable laws, rules or regulations. At least [*] in advance of each labeling run, GSK Canada shall supply McKesson with the labels, cartons and leaflets required for such run and written instructions that specify the appropriate packaging components for each product configuration to be prepared in such run. GSK Canada shall inform Corixa prior to sending labels, cartons or leaflets to McKesson, and Corixa will promptly pass such information along to McKesson. The minimum batch size for vial labeling Tositumomab for provision to GSK Canada shall be [*] Cold Components, with the exception that, in calendar year 2003, [*] run will be performed on behalf of GSK Canada for [*] Cold Components ordered by GSK Canada for such year, even though such number is less than [*]. During the rest of the term of this Agreement, GSK Canada may request that vial labeling be performed upon batches of less than [*] Cold Components. Such reduced batch size vial labeling runs will be performed only if McKesson agrees to perform such runs and if GSK Canada agrees to [*] Labeled, packaged Tositumomab will be delivered to GSK Canada, in accordance with Section 4.5(a), in the shipping container that was validated by McKesson, on behalf of Corixa, prior to the Effective Date or any mutually agreed substitute for such shipping container. A temperature monitoring device shall be placed inside such shipping container.. (b) IODINE I 131 TOSITUMOMAB. All Iodine I 131 Tositumomab shall be labeled with a primary label on the glass vial and a secondary label on the lead pig. GSK Canada shall provide to Nordion pre-approved secondary labels and leaflets (which leaflets shall be 8.5 x 11 inches in size) for Iodine I 131 Tositumomab that comply with all applicable laws, rules and regulations in the Territory. Neither Nordion nor Corixa shall have any obligation to inspect or approve such labels or leaflets, except for any obligations imposed by applicable laws, rules or regulations. At least [*] in advance of each labeling run, GSK Canada shall supply ---------------------------------- * Confidential Treatment requested. 29. <PAGE> Nordion with the labels and leaflets required for such run and written instructions that specify the appropriate label(s) and leaflets for each product configuration to be prepared in such run. 4.5
Appears in 1 contract
Samples: License and Supply Agreement
TOSITUMOMAB. For all Tositumomab provided to GSK Canada hereunder, Corixa shall provide to McKesson GSK Canada, within fifteen (or another Third Party contract labeler 15) business days of CorixaMcKesson's release, (i) pre-approved labelsBI Pharma's Certificate of Analysis and Batch Certificate, cartons (ii) McKesson's Certificate of Manufacture, and leaflets for Tositumomab that comply with all applicable laws, rules and regulations in the Territory. Neither McKesson nor Corixa shall have any obligation to inspect or approve such labels, except for any obligations imposed by applicable laws, rules or regulations. At least [*] in advance of each labeling run, GSK Canada shall supply McKesson with the labels, cartons and leaflets required for such run and written instructions that specify the appropriate packaging components for each product configuration to be prepared in such run(iii) a label specimen. GSK Canada shall inform Corixa prior to sending labels, cartons or leaflets to McKesson, and Corixa will promptly pass review such information along to McKessonitems within ten (10) business days of receipt. The minimum batch size for vial labeling Any Tositumomab for provision to GSK Canada shall be [*] Cold Components, with the exception that, in calendar year 2003, [*] run will be performed on behalf of GSK Canada for [*] Cold Components ordered by GSK Canada for such year, even though such number is less than [*]. During but rejected by Corixa or its agent on account of failure to comply with the rest of the term of this Agreement, GSK Canada may request that vial labeling be performed upon batches of less than [*] Cold Components. Such reduced batch size vial labeling runs Specifications will be performed only if McKesson agrees to perform such runs and if GSK Canada agrees to [*] Labeled, packaged Tositumomab will not be delivered to GSK Canada. With respect to all Tositumomab not so rejected, GSK Canada shall provide approval to Corixa to ship Tositumomab to GSK Canada unless such analysis certificates provided by Corixa demonstrate that such Tositumomab does not conform with the Specifications. In such case, GSK Canada shall promptly inform Corixa and Corixa will reject such Tositumomab. 32. <PAGE> GSK Canada will perform an identification test upon receipt of Tositumomab in accordance Canada. If the Tositumomab passes the identification test GSK Canada will release the Tositumomab. If the Tositumomab fails the identification test, GSK Canada shall promptly inform Corixa and reject the Tositumomab. In such case, Corixa and GSK Canada will discuss the batch rejection and identify the root cause. If the cause of the rejection was a result of the failure of either BI Pharma or McKesson to comply with Section 4.5(athe specified order and contract terms with Corixa, Corixa shall use commercially reasonable efforts to procure from BI Pharma or McKesson, as applicable, any remedy available to Corixa pursuant to the BI Pharma Agreement or McKesson Agreement, as applicable, for such identification test failure. Corixa shall make available to GSK Canada all remedies so procured by Corixa. GSK Canada shall be responsible for setting up adequate facilities and procedures for handling, storing and disposing of Tositumomab that does not pass the identification test. (b) IODINE I 131 TOSITUMOMAB. (i) For all Iodine I 131 Tositumomab provided to GSK Canada hereunder, Corixa shall provide to GSK Canada (1) a label specimen, (2) Nordion's Certificate of Analysis and Certificate of Manufacture, and (3) BI Pharma's Certificate of Analysis and Batch Certificate for the Packaged Bulk Drug Substance used by Nordion. Corixa shall provide the BI Pharma documentation on a one-time basis following the release of each Packaged Bulk Drug Substance batch, and GSK Canada will be responsible for maintaining archived Packaged Bulk Drug Substance release documents for Packaged Bulk Drug Substance batches used at Nordion. After Corixa has completed its release of the Product, Corixa shall provide the label specimen and Nordion documentation by [*] on the [*], provided that there is not a delay in obtaining the requisite information from Nordion. If such Iodine I 131 Tositumomab is for therapeutic purposes and is manufactured by Nordion in a batch that includes Iodine I 131 Tositumomab intended for use in Europe (a "European Batch"), Corixa shall provide the label specimen and Nordion documentation by [*] on the [*], provided that there is not a delay in obtaining the shipping container that was validated by McKesson, on behalf of Corixa, requisite information from Nordion. Corixa will inform GSK Canada at least [*] prior to the Effective Date or any mutually agreed substitute [*] if the batch being made on such date is a European Batch. (ii) GSK Canada shall review the items provided by Corixa pursuant to Section 4.7(b)(i) within [*] after GSK Canada's receipt of the label specimen and Nordion documentation (but no later than [*] on the [*] or, with respect to each European Batch, no later than [*] on the day after the [*]), unless Corixa provides such label specimen and Nordion documentation more than [*] before the deadline for such shipping containerprovision (in which case, GSK shall complete such review within [*] of receipt). A temperature monitoring device Any Iodine I 131 Tositumomab ordered by GSK Canada but rejected by Corixa or its agent on account of failure to comply with the Specifications will not be delivered to GSK Canada. With respect to all such Iodine I 131 Tositumomab not so rejected, GSK Canada shall send a facsimile to Corixa releasing such Iodine I 131 Tositumomab by the review deadline stated in this Section 4.7(b)(ii) (but not later than [*] on the [*] or, with respect to each European Batch, not ---------------------------------- * Confidential Treatment requested. 33. <PAGE> later than [*] on the day after the [*], unless such Certificates of Analysis provided by Corixa demonstrates that such Iodine I 131 Tositumomab does not conform with the Specifications. In such case, GSK Canada shall promptly inform Corixa by telephone and Corixa will reject such Iodine I 131 Tositumomab, provided that the time for rejection has not passed. GSK Canada shall be placed inside responsible for setting up adequate facilities and procedures for handling, storing and disposing of Iodine I 131 Tositumomab that does not conform with Specifications and that has been shipped from Nordion prior to a determination of failure to comply with Specifications. GSK Canada shall not be responsible for any failure of Nordion to handle, store and dispose of Iodine I 131 Tositumomab that does not conform with Specifications and that has not been shipped from the Nordion facility at the time of determination of failure to comply with Specifications, except that GSK Canada shall pay all costs associated with Nordion's handling, storage and disposal of Iodine I 131 Tositumomab that fails to comply with Specifications on account of GSK Canada's error or omission. GSK Canada understands that [*]. Corixa will use commercially reasonable efforts to ensure that Nordion completes [*] as promptly as possible and within [*] of release. Corixa will forthwith provide GSK Canada with the results of such testing once received by Corixa. (iii) GSK Canada understands that, under the Nordion shipping container.practices in effect on the Effective Date, the Iodine I 131 Tositumomab that GSK Canada releases by the review deadline stated in Section 4.7(b)(ii) are eligible for shipment (1) by Purolator or FedEx, departing on the [*], (2) by Air Canada, departing [*], or (3) by truck, departing [*] and driving to Ottawa or Montreal hospitals. 4.8
Appears in 1 contract
Samples: License and Supply Agreement
