Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Company, Merck shall provide Company with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Company shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company shall be solely responsible for taking all steps necessary to determine that Merck Compound or Company Compound, as applicable, is suitable for release before making such Merck Compound or Company Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the Merck Compound. Company shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Company shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Company hereunder.
Product Testing; Noncompliance. 8.8.1 After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to BioLineRx, Merck shall provide BioLineRx with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). BioLineRx shall, within the time defined in the Clinical Quality Agreement, perform (i) with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the BioLineRx Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement. BioLineRx shall be solely responsible for taking all steps necessary to determine that Merck Compound or BioLineRx Compound, as applicable, is suitable for release before making such Merck Compound or BioLineRx Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by BioLineRx in connection with such determination with respect to the Merck Compound. BioLineRx shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law, and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. BioLineRx shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to BioLineRx hereunder.
Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Adaptimmune, Merck shall provide Adaptimmune with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Adaptimmune shall, within the time defined in the Clinical Quality Agreement, perform with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Adaptimmune shall be solely responsible for taking all steps necessary to determine that Merck Compound or Adaptimmune Compound, as applicable, is suitable for release before making such Merck Compound or Adaptimmune Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Adaptimmune in connection with such determination with respect to the Merck Compound. Adaptimmune shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Adaptimmune shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Adaptimmune hereunder.
Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Antigen Express, Merck shall provide Antigen Express with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Antigen Express shall, within the time defined in the Clinical Quality Agreement, perform with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Antigen Express shall be solely responsible for taking all steps necessary to determine that Merck Compound or Antigen Express Compound, as applicable, is suitable for release before making such Merck Compound or Antigen Express Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Antigen Express in connection with such determination with respect to the Merck Compound. Antigen Express shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Antigen Express shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Antigen Express hereunder.
Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to FLX, Merck shall provide FLX with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). FLX shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. FLX shall be solely responsible for taking all steps necessary to determine that Merck Compound or FLX Compound, as applicable, is suitable for release before making such Merck Compound or FLX Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by FLX in connection with such determination with respect to the Merck Compound. FLX shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. FLX shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to FLX hereunder.
Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the MSD Compound and concurrently with Delivery of such MSD Compound to Novocure, MSD shall provide Novocure with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Novocure shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the MSD Compound, the acceptance procedures allocated to it under the Clinical Quality Agreement. Novocure shall be solely responsible for taking all steps necessary to determine that MSD Compound is suitable for release before making such MSD Compound available for human use, and MSD shall provide cooperation or assistance as reasonably requested by Novocure in connection with such determination with respect to the MSD Compound. Novocure shall be responsible for storage and maintenance of the MSD Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the MSD Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by MSD from time to time. Novocure shall be responsible for any failure of the MSD Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Novocure hereunder. Novocure shall be solely responsible for taking all steps necessary to determine the suitability of the Novocure Device for human use. 8.8.2.
Product Testing; Noncompliance. After Manufacturer’s Release of the SpringWorks Compound but prior to shipment to GSK, SpringWorks shall provide GSK with such certificates and documentation as described in the Clinical Quality Agreement. GSK shall, within the time defined in the Clinical Quality Agreement, perform (a) with respect to the SpringWorks Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement, and (b) with respect to the GSK BCMA Product, the testing and release procedures allocated to it under the Clinical Quality Agreement. 12.12
Product Testing; Noncompliance. Purchaser shall have [*] days from the date of delivery of Drug Product to Purchaser’s premises in which to test, at Purchaser’s cost, a shipment for compliance with the Specifications and notify Amgen of any non-compliance. Purchaser shall use its reasonably diligent efforts to obtain and test the Drug Product as soon as reasonably practicable. Amgen and Purchaser shall agree on the testing procedures to be employed and the Third Parties to be contracted to conduct testing hereunder. Purchaser shall be responsible for storage and maintenance of the Drug Product until it is tested and released. In the event Purchaser determines that a shipment of Drug Product (or portion thereof) did not, upon delivery, meet the Specifications, Purchaser shall notify Amgen in writing (within the [*] day period set forth above) and provide Amgen with complete copies of all testing data and a reasonably detailed explanation of the reasons for such suspected non-compliance. If Amgen disagrees with such initial determination of non-compliance and the Parties can not come to agreement, Amgen and Purchaser shall elect an independent Third Party to review the data and/or repeat the testing and make a final determination, which shall be binding upon both Purchaser and Amgen. If the shipment is determined by the independent Third Party to have been, upon delivery, in compliance with the Specifications, Purchaser shall pay the costs of such testing; if the shipment is found not to have been in compliance with the Specifications upon delivery, Amgen shall pay the costs of such testing. In the event any shipment (or portion thereof) shall be agreed or determined pursuant to this Section 2.7 (Product Testing; Noncompliance) to have failed to comply with the Specifications upon delivery, Purchaser shall, at Amgen’s election and expense, either destroy the shipment or return the shipment to Amgen. Amgen shall replace the Available SKUs found to have been not in compliance with the Specifications upon delivery, as Purchaser’s sole remedy (other than indemnity under Section 6.2.2 (Amgen Obligation)) with respect to such non-complying Drug Product. Purchaser shall be responsible for, and Amgen shall have no obligation to provide replacement Drug Product for, any Available SKUs supplied hereunder other than the Available SKUs agreed or determined to be not in compliance with the Specifications upon delivery. Purchaser shall be solely responsible for taking all steps necessary to determine th...
Product Testing; Noncompliance. 8.5.1 After Manufacturer's Release. After manufacturer's release of the Lilly Compound and concurrently with Delivery of the Compound to Sponsor, Lilly shall provide Sponsor with such certificates and documentation as are described in the Quality Agreement. Sponsor shall, within the time defined in the Quality CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 16 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.
Product Testing; Noncompliance. 8.7.1 After Manufacturer's Release. After Manufacturer's Release of Menarini Compound and concurrently with Delivery of the Compound to Context, Menarini shall provide Context with such certificates and documentation as are described in the Quality Agreement (“Disposition Package”). Context shall take all steps necessary to determine that the Context Compound or Menarini Compound, as applicable, is suitable for release before making such Context Compound or Menarini Compound, as applicable, available for human use, and Menarini shall provide cooperation or assistance as reasonably requested by Context in connection with such determination with respect to the Menarini Compound. Context shall be responsible for storage and maintenance of Menarini Compound until it is tested and/or released, which storage and maintenance shall be in compliance with the Specifications for the applicable Menarini Compound, and Applicable Law, and shall be responsible for any failure of the Menarini Compound to meet the Specifications to the extent caused by shipping, storage, or handling conditions after Delivery to Context hereunder.
