Common use of TOSITUMOMAB Clause in Contracts

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.

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(a)the specified order and contract terms with Corixa, in the shipping container that was validated by Corixa shall use commercially reasonable efforts to procure from BI Pharma or McKesson, on behalf of Corixaas applicable, prior any remedy available to Corixa pursuant to the Effective Date BI Pharma Agreement or any mutually agreed substitute McKesson Agreement, as applicable, for such shipping containeridentification test failure. A temperature monitoring device Corixa shall make available to GSK Canada all remedies so procured by Corixa. GSK Canada shall be placed inside such shipping containerresponsible for setting up adequate facilities and procedures for handling, storing and disposing of Tositumomab that does not pass the identification test.