After Manufacturer’s Release. After Manufacturer’s Release of the MSD Compound and concurrently with Delivery of the Compound to Collaborator, MSD shall provide Collaborator with the documentation described in the Clinical Quality Agreement. Collaborator shall conduct the acceptance procedures under the Clinical Quality Agreement within the time frames set forth therein. Collaborator shall be solely responsible for taking all steps necessary to determine that MSD Compound or Collaborator Compound, as applicable, is suitable for release before making such Compounds available for human use, and MSD shall assist Collaborator as Collaborator reasonably requests in making such determination for the MSD Compound. Collaborator shall be responsible for storage and maintenance of the MSD Compound until it is tested and released, which storage and maintenance shall be in compliance with: (i) the Specifications for the MSD Compound, (ii) the Clinical Quality Agreement, (iii) Applicable Law, and (iv) any specific storage and maintenance requirements as may be provided by MSD from time to time. Collaborator shall be responsible for any failure of the MSD Compound to meet the Specifications to the extent caused after Delivery to Collaborator hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of Pfizer Compound and concurrently with Delivery of the Compound to Ideaya, Pfizer shall provide Ideaya with such certificates and documentation as are described in the Quality Agreement (“Disposition Package”). Ideaya shall, within the time defined in the Quality Agreement, perform (i) with respect to such Pfizer Compound, the acceptance procedures allocated to it under the Quality Agreement, and (ii) with respect to the Ideaya Compound, the testing [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. and release procedures allocated to it under the Quality Agreement. Ideaya shall take all steps reasonably necessary to determine that the Ideaya Compound or Pfizer Compound, as applicable, is suitable for release before making such Ideaya Compound or Pfizer Compound, as applicable, available for human use, and Pfizer shall provide cooperation or assistance as reasonably requested by Ideaya in connection with such determination with respect to a Pfizer Compound. Ideaya shall be responsible for storage and maintenance of Pfizer Compound until it is tested and/or released, which storage and maintenance shall be in compliance with the Specifications for the applicable Pfizer Compound, the Quality Agreement and Applicable Law, and shall be responsible for any failure of the Pfizer Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Ideaya hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Syndax, Merck shall provide Syndax with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Syndax shall, within the time defined in the Clinical Quality Agreement, perform (i) with respect to the Merck Compound, the acceptance procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the Syndax Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement. Syndax shall take all steps necessary to determine that the Syndax Compound or Merck Compound, as applicable, is suitable for release before making such Syndax Compound or Merck Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Syndax in connection with such determination with respect to the Merck Compound. Syndax 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 the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law, and 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 Syndax hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of the ImmunoGen Compound and concurrently with Delivery of the Compound to Xxxxxxxx, ImmunoGen shall provide Xxxxxxxx with such certificates and documentation as are described in the Clinical Quality Agreement. Xxxxxxxx shall, within the time defined in the Clinical Quality Agreement, perform (i) with respect to the ImmunoGen Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the Xxxxxxxx Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement. Xxxxxxxx shall be solely responsible for taking all steps necessary to determine that ImmunoGen Compound or Xxxxxxxx Compound, as applicable, is suitable for release before making such ImmunoGen Compound or Xxxxxxxx Compound, as applicable, available for human use, and ImmunoGen shall provide cooperation or assistance as reasonably requested by Xxxxxxxx in connection with such determination with respect to the ImmunoGen Compound. Upon Delivery, Xxxxxxxx shall be responsible for storage and maintenance of the ImmunoGen Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the ImmunoGen Compound, the Clinical Quality Agreement and Applicable Law, and (b) any specific storage and maintenance requirements as may be provided in writing by ImmunoGen from time to time that do not conflict with Applicable Law or the Clinical Quality Agreement. Xxxxxxxx shall be responsible for any failure of the ImmunoGen Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Xxxxxxxx hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of Merck Compound and concurrently with Delivery of the Compound to Vaccinex, Merck shall provide Vaccinex with such certificates and documentation as are described in the Clinical Quality Agreements (“Disposition Package”). Vaccinex shall, within the time defined in the Clinical Quality Agreements, perform (i) with respect to Merck Compound, the acceptance procedures [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. allocated to it under the Clinical Quality Agreements, and (ii) with respect to the Vaccinex Compound, the testing and release procedures allocated to it under the Clinical Quality Agreements. Vaccinex shall take all steps necessary in its reasonable discretion to determine that Vaccinex Compound is suitable for release from its manufacturing site and that Merck Compound and Vaccinex Compound are suitable for release from Vaccinex Packaging and Labeling Contractor Site before making such Merck Compound or Vaccinex Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Vaccinex in connection with such determination with respect to Merck Compound. Vaccinex shall be responsible for (a) storage and maintenance of Merck Compound until it is released from Vaccinex Packaging and Labeling Contractor Site, which storage and maintenance shall be in compliance with the Specifications for Merck Compound, the Clinical Quality Agreements and Applicable Law; and (b) any failure of Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Vaccinex hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of the MSD Compound and concurrently with Delivery of the MSD Compound to Company, MSD and/or its Affiliate(s) 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 MSD 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 MSD Compound or Company Compounds, as applicable, is suitable for release before making such MSD Compound or Company Compounds, as applicable, available for human use, and MSD and/or its Affiliate(s) shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the MSD Compound. For clarity, Company’s obligations under the immediately preceding sentence with respect to the MSD Compound shall consist of the performance of acceptance testing procedures and review of the certificates of analysis and other documentation that Company is required to review pursuant to the Clinical Quality Agreement. Company 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. Company 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 Company hereunder.
After Manufacturer’s Release. After manufacturer’s release of the Xxxxx Xxxxxxxx and concurrently with Delivery of the Compound to Sponsor, Xxxxx shall provide Sponsor with such certificates and documentation as are described in the Quality Agreement. Sponsor shall, within the time defined in the Quality Agreement, perform with respect to the Lilly Compound, the acceptance procedures allocated to it under the Quality Agreement. Further, with respect to the Sponsor Compound, Sponsor shall perform acceptance procedures consistent with its internal testing and release procedures. Sponsor shall take all steps necessary to determine that the Sponsor Compound is suitable for release before making such Sponsor Compound available for human use, and Xxxxx shall provide reasonable cooperation or assistance as reasonably requested by Sponsor in connection with such determination with respect to the Lilly Compound. After Delivery by Xxxxx of the Lilly Compound, Sponsor shall be responsible for storage and maintenance of the Lilly Compound, which storage and maintenance shall be in compliance with the Specifications for the Lilly Compound, the Quality Agreement and Applicable Law, and shall be responsible for any failure of the Lilly Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Sponsor hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of the Advaxis Compound but prior to shipment to Incyte, Advaxis shall provide Incyte with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Incyte shall, upon receipt of the Advaxis Compound and within the time defined in the Clinical Quality Agreement, perform (i) with respect to the Advaxis Compound, the acceptance (including applicable testing) procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the Incyte Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement. Once Incyte has received and performed the acceptance procedures on the Advaxis Compound, Incyte shall be solely responsible for taking all steps necessary to determine that the Advaxis Compound or Incyte Compound, as applicable, is suitable for release before making such Advaxis Compound or Incyte Compound, as applicable, available for human use. For clarity, Incyte shall store and maintain the Advaxis Compound until it is released, which storage and maintenance shall be in compliance with (a) the Specifications for the Advaxis Compound, the Clinical Quality Agreement and Applicable Law, and (b) any specific storage and maintenance requirements as may be provided by Advaxis from time to time.
After Manufacturer’s Release. After Manufacturer’s Release of the Alliance Compound and Checkmate Compound, as applicable, and concurrently with Delivery of the Compound to Pfizer, the Alliance and Checkmate shall provide Pfizer with such certificates and documentation as are described in the Quality Agreements (“Disposition Package”). Pfizer shall, within the time defined in the Quality Agreements, perform (i) with respect to the Alliance Compound and Checkmate Compound, as applicable, the acceptance procedures allocated to it under the Quality Agreements, and (ii) with respect to the Alliance Compound and Checkmate Compound, as applicable, the testing and release procedures allocated to it under the Quality Agreements. Pfizer shall take all steps necessary in its reasonable discretion to determine that the Alliance Compound, Checkmate Compound or Pfizer Compound, as applicable, is suitable for distribution before making such Alliance Compound, Checkmate Compound or Pfizer Compound, as applicable, available for human use, and the Alliance and Checkmate, as applicable, shall provide cooperation or assistance as reasonably requested by Pfizer in connection with such determination with respect to the Alliance Compound and Checkmate Compound, as applicable. Pfizer shall be responsible for (a) storage and maintenance of the Alliance Compound and Checkmate Compound until it is tested and/or released, which storage and maintenance shall be in compliance with the Specifications for the Alliance Compound or Checkmate Compound, as applicable, the Quality Agreements and Applicable Law; and (b) any failure of the Alliance Compound or Checkmate Compound, as applicable, to meet the applicable Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Pfizer hereunder.
After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound but prior to or at the time of shipment to Advaxis, Merck shall provide Advaxis with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Advaxis shall, within the time defined in the Clinical Quality Agreement, perform (i) with respect to the Merck Compound, the acceptance procedures allocated to it under the Clinical Quality Agreement, and (ii) with respect to the Advaxis Compound, the testing and release procedures allocated to it under the Clinical Quality Agreement. Advaxis shall be solely responsible for taking all steps necessary to determine that the Merck Compound or the Advaxis Compound, as applicable, is suitable for release before making such Merck Compound or Advaxis Compound, as applicable, available for human use. For clarity, Advaxis 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.
