IODINE I 131 TOSITUMOMAB Sample Clauses

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 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. ---------------------------------- * Confidential Treatment requested. Redacted
Sample 1
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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.
Sample 1
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 requisite information from Nordion. Corixa will inform GSK Canada at least [*] prior to the [*] 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 provision (in which case, GSK shall complete such review within [*] of receipt). 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.
Sample 1
IODINE I 131 TOSITUMOMAB 
Sample 1

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