TOSITUMOMAB Sample Clauses

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.
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TOSITUMOMAB. Any orders placed with BI Pharma shall be a "Vested Order" for purposes of this Section 4.16(b), if it is a firm order which has been accepted by BI Pharma and is scheduled for delivery within [*] after the date of such order. (i) If Corixa seeks to place a proposed Vested Order for Tositumomab and is advised by BI Pharma that it will not accept the full amount of such order (in which case such order does not become a Vested Order), whether such order is for purposes of supply in the Territory or the Corixa Territory, then Corixa shall consult with GSK Canada regarding the allocation of available supply. Unless the Parties otherwise agree, all future Vested Orders shall be allocated [*] to the Territory and [*] to the Corixa Territory so long as such conditions of supply shortage prevail, with each lot being allocated in such pro rata manner. In the event that, over the course of the 12-month period following BI Pharma's refusal to accept the full amount of such order, BI Pharma also refuses to accept the full amount of each and every subsequent order which Corixa attempts to place as a Vested Order, the Parties shall meet to discuss a plan for remedying such shortage of Tositumomab. (ii) If BI Pharma is unable to deliver the full amount of a Vested Order, either because the amount delivered is less than the amount ordered or because some or all of the delivery is not accepted for any reason, including, without limitation, non-compliance with Specifications, then the available Tositumomab in each calendar year in which a shortage of supply prevails shall be allocated as between the Territory and the Corixa Territory [*]. If the shortfall or failure occurs in a batch which is part of a manufacturing campaign, then the acceptable material manufactured as part of that campaign, and all future deliveries in that calendar year, shall be allocated between the Territory and the Corixa Territory so as to [*]. (Such allocation on a campaign basis could require that material already received as part of the same campaign for use in one territory be redesignated for use in a different territory, if such redesignation is necessary in order to achieve the [*]. However, material received as part of previous campaigns shall not be redesignated except by mutual consent.) As used herein, a "manufacturing campaign" shall refer to two or more batches manufactured in the same ---------------------------------- * Confidential Treatment requested.
Sample 1
TOSITUMOMAB. (a) OVERVIEW. Except as set forth in Sections 3.1(e) and 3.11, and subject to availability of Tositumomab and Amersham's compliance with the terms and conditions of this Agreement and the License Agreement, Corixa shall use commercially reasonable efforts to have manufactured and supply to Amersham all of its requirements in the Territory for Tositumomab in accordance with the BI Pharma Agreements and the volume allocation methodology set forth in Section 3.11. Amersham shall pay for such Tositumomab as set forth in Article 4. Except as set forth in Section 3.1(e), Amersham shall obtain from Corixa all of Amersham's requirements for Tositumomab in the Territory, whether for development or commercial sale.
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TOSITUMOMAB. For all Tositumomab provided to GSK Canada hereunder, Corixa shall provide to GSK Canada, within [*]days of McKesson's release, (i) BI Pharma's Certificate of Analysis and Batch Certificate, (ii) McKesson's Certificate of Manufacture, and (iii) a label specimen. GSK Canada shall review such items within [*] days of receipt. Any 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 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. GSK Canada will perform an identification test upon receipt of Tositumomab in 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 ------------------------------ * Confidential Treatment requested. Redacted
Sample 1
TOSITUMOMAB. For all Tositumomab provided to GSK Canada hereunder, Corixa shall provide to GSK Canada, within fifteen (15) business days of McKesson's release, (i) BI Pharma's Certificate of Analysis and Batch Certificate, (ii) McKesson's Certificate of Manufacture, and (iii) a label specimen. GSK Canada shall review such items within ten (10) business days of receipt. Any 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 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.
Sample 1

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