Lot Documentation Package definition

Lot Documentation Package has the meaning given in Section 2.1(c)(ii).
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Lot Documentation Package means all of the following related to a given Lot: (a) with respect to API, Certificates of Analysis and Compliance, a summary list of Discrepancy Reports, and the actual Discrepancy Reports upon request by Chiron where required to release Filled Product in the Territory and (b) with respect to Filled Product, Certificates of Analysis and Compliance, batch production records, Discrepancy Reports, lot disposition form(s) signed by Cubist and customs related documentation required to export from the country of manufacture. In any event, Cubist shall provide Chiron all documentation required by the Regulatory Authorities. If actual Discrepancy Reports are necessary for Chiron to comply with the requirements of the Regulatory Authorities in the Territory and Chiron has submitted such request to Cubist, thereafter, Cubist shall provide with each Lot the actual Discrepancy Reports (not merely the summaries thereof). 1.31 "MANUFACTURING COST" shall have the meaning assigned to such term in Section 7.1(b). 1.32 "MANUFACTURING INFORMATION" shall have the meaning assigned to such term in Section 5.3(d) of the License Agreement. 1.33 "MAXIMUM QUANTITIES" shall have the meaning assigned to such term in Section 4.2. 1.34 "NON-BREACHING PARTY" shall have the meaning assigned to such term in Section 11.4(a). 1.35 "NON-CONFORMING PRODUCT," or "NON-CONFORMING," with respect to Filled Product, shall mean any Filled Product that is not Conforming Product. 1.36 "NOTIFIED PARTY" shall have the meaning assigned to such term in Section 11.4(a). 1.37 "PACKAGING SPECIFICATIONS" shall mean those specifications for the packaging and shipment of Filled Product agreed upon in writing by the Parties pursuant to Section 3.1. * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION 4 <Page> 1.38 "PRODUCT SHORTAGE" shall have the meaning assigned to such term in Section 8.2. 1.39 "PURCHASE ORDER" shall have the meaning assigned to such term in Section 4.3. 1.40 "QC" shall mean quality control. 1.41 "QUALITY AGREEMENT" shall have the meaning assigned to such term in Section 3.10. 1.42 "REGULATORY APPROVAL" shall mean (i) in the United States, approval by the FDA of an NDA or equivalent and satisfaction of any related applicable FDA registration and notification requirements, and (ii) any equivalent approval in any country other than the United States. 1.43 "REGULATORY AUTHORITIES" shall mean foreign counterparts of the FDA in the Territory, and other gove...
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Lot Documentation Package means all of the following related to a given Lot: (a) with respect to API, Certificates of Analysis and Compliance, a summary list of Discrepancy Reports, and the actual Discrepancy Reports upon request by Chiron where required to release Filled Product in the Territory and (b) with respect to Filled Product, Certificates of Analysis and Compliance, batch production records, Discrepancy Reports, lot disposition form(s) signed by Cubist and customs related documentation required to export from the country of manufacture. In any event, Cubist shall provide Chiron all documentation required by the Regulatory Authorities. If actual Discrepancy Reports are necessary for Chiron to comply with the requirements of the Regulatory Authorities in the Territory and Chiron has submitted such request to Cubist, thereafter, Cubist shall provide with each Lot the actual Discrepancy Reports (not merely the summaries thereof).
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Examples of Lot Documentation Package in a sentence

  • Chiron may reject any Non-Conforming Product by delivering written notice thereof to Cubist within [*] of Chiron's receipt of (a) pre-shipment samples and the related Lot Documentation Package, in cases in which Chiron has requested and received pre-shipment samples pursuant to Section 5.1, or (b) ordered Filled Product and related Lot Documentation Package, in cases in which Chiron has not requested and received pre-shipment samples of ordered Filled Product.

  • Cubist shall be responsible for releasing each lot of API and Filled Product and shall certify that each such released lot was manufactured and tested in accordance with applicable cGMPs, manufacturing procedures, Specifications and Applicable Laws and providing Lot Documentation Package confirming same.

  • Upon written request by Chiron made upon or after placement of any Purchase Order, Cubist shall (a) provide to the Carrier, on a mutually agreed date in advance of the Delivery Date specified in such Purchase Order, pre-shipment samples from Lots manufactured for an order of Filled Product, and (b) as soon thereafter as reasonably practicable, provide Chiron with the associated Lot Documentation Package.

  • For the avoidance of any doubt, Viking may inspect and test and reject by sample and on a batch-by-batch basis, may inspect by inspection of the Final Lot Release Testing Results and otherwise the Lot Documentation Package and, without limitation of any of Corden’s testing obligations or other obligations under this Agreement, may inspect and/or test by conducting or having a Third Party conduct additional testing at [...***...]’s cost and expense.

  • Unless otherwise requested by Viking in writing, Corden shall provide the Lot Documentation Package (including, for the avoidance of any doubt, the Final Lot Release Testing Results) to Viking for any API transferred to storage upon transfer to storage under this Section 2.4.1.

  • If any Iron Products supplied to FUSA by or on behalf of Luitpold/AR fail to conform to the applicable Product Specifications based on an inspection by FUSA of such Iron Product and packaging and shipping materials and components, including results of the applicable quality review and approval, including review of the batch record, Lot Documentation Package and other manufacturing documentation, then FUSA shall have the right to reject such non-conforming Iron Products.

  • Luitpold/AR shall conduct quality assurance tests on the Iron Products prior to shipment to in accordance with FDA requirements, shall furnish upon FUSA’s request and at FUSA’s cost samples to FUSA, and shall maintain appropriate documentation of each Lot included in the shipment in accordance with all applicable U.S. laws and regulations, including without limitation, the Lot Documentation Package.


More Definitions of Lot Documentation Package

Lot Documentation Package means all of the following related to a given Lot: (a) with respect to API, a Certificate of Analysis and Compliance, a summary list of Discrepancy Reports, and the actual Discrepancy Reports upon request by FUSA where required to release any Iron Product in the Territory and (b) with respect to Iron Products, a Certificate of Analysis and Compliance, batch production records, Discrepancy Reports and lot disposition form(s) signed by Luitpold/AR. In any event, Luitpold/AR shall provide FUSA all documentation required by the FDA or any Governmental Authority. If actual Discrepancy Reports are necessary for FUSA to comply with the requirements of the FDA or any Governmental Authority in the Territory and FUSA has submitted such request to Luitpold/AR, thereafter, the Lot Documentation Package shall include for each Lot the actual Discrepancy Reports (not merely the summaries thereof).
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