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 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 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. [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 8.8.1 After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Rexahn, Merck shall provide Rexahn with such certificates and documentation as are described in the Clinical Quality Agreement. Rexahn 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. Subject to Section 2.3.2, Rexahn shall be responsible for taking all steps necessary to determine that Merck Compound or Rexahn Compound, as applicable, is suitable for release before making such Merck Compound or Rexahn Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Rexahn in connection with such determination with respect to the Merck Compound. Rexahn 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 written specific storage and maintenance requirements as may be provided by Merck from time to time. Rexahn 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 Rexahn 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 Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement.
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 PDS, Merck shall provide PDS with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). PDS 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. PDS shall be solely responsible for taking all steps necessary to determine that Merck Compound or PDS Compound, as applicable, is suitable for release before making such Merck Compound or PDS Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by PDS in connection with such determination with respect to the Merck Compound. PDS 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. PDS 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 PDS hereunder. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filled separately with the Commission.
Product Testing; Noncompliance. The process for activities regarding product testing and noncompliance will be handled in accordance with the provisions set forth in the Clinical Quality Agreement.
