Disposition Package definition

Disposition Package has the meaning set forth in Section 8.8.1.

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Disposition Package means the compilation of data, records and documentation for a GMP Batch, including but not limited to, executed batch manufacturing records, genealogy, certificate of analysis (“COA”) and associated Quality Control data, and any other data, records or documentation required under the Quality Agreement.

Examples of Disposition Package in a sentence

Documents comprising the Disposition Package are provided in Exhibit B.
Disposition Package Documentation set provided to COMPANY representing AMGEN batch Disposition disposition of the Product.
Disposition Package Documentation set provided to COMPANY representing AMGEN batch disposition of the Product.
The documents to be included in the Disposition Package are provided in Exhibit B.
Disposition Package Documentation set provided that represents the joint batch disposition of the Product.
The Disposition Package will be prepared and reviewed by a Disposition Manager to confirm completeness of the package and determine the batch disposition based on a comprehensive quality assessment of the batch.
The documents to be included in each Disposition Package are provided in Attachment B.
Documents comprising the Disposition Package are provided ‘in Exhibit B.
A certificate of analysis shall accompany each shipment of the Merck Compound to Syndax, as part of the Disposition Package described in Section 8.7.
Within [***] after Alder’s receipt of the Disposition Package together with any requested samples, Alder shall review the Disposition Package in order to determine, to the extent reasonably ascertainable therefrom and subject to Alder’s rights below, whether it agrees with Fujifilm’s findings in the Disposition Package, and, in particular, with Fujifilm’s determination of conformity or non-conformity.

More Definitions of Disposition Package

Disposition Package has the meaning set forth in Section 8.7.1 (After Manufacturer’s Release).

Disposition Package has the meaning set forth in Section 8.8.1. 1.22. “Effective Date” has the meaning set forth in the preamble. 1.23. “EMA” has the meaning set forth in the definition of Applicable Law. 1.24. “Exclusions List” has the meaning set forth in the definition of Violation. 1.25. “FDA” has the meaning set forth in the definition of Applicable Law. 1.26. “Filing Party” has the meaning set forth in Section 10.1.1(c). 1.27. “Final Study Report” has the meaning set forth in Section 3.11. 1.28. “Force Majeure” has the meaning set forth Article 16.

Disposition Package means, with respect to any shipment of Drug Product, the documentation and records defined pursuant to the relevant Quality Agreement (as defined in Section 2.8), which may include copies of the Certificate of Analysis, Certificate of Compliance, quality control documentation and manufacturing batch records for such shipment; written confirmation that such batch records have been reviewed and approved by Patheon quality assurance unit; and any other documentation required by law that is in Patheon’s possession and required by Gilead for the release of the batch or batches of Drug Product in such shipment.

Disposition Package means a written proposal submitted to USTK by the Servicer which shall identify the Timberland Investment that the Servicer believes should be disposed of, the reasons for the disposition recommendation (including the risks and opportunities of the disposition), potential purchasers/bidders, assessment of the risks and opportunities of continuing to hold the Timberland Investment, expected disposition expenses, the Servicer's proposed strategy for marketing and effectuating the disposition, the recommended sales price (including appraisals or other data, calculations and assumptions supporting such recommendation) and any other matter reasonably requested by USTK.

Disposition Package shall have the meaning specified in Section 5.03.