Release Testing. IceCure shall test each applicable batch or serial of Product in accordance with the Specification Agreement (as defined in Exhibit 1.37) and the Quality Agreement. Prior to the Delivery, IceCure shall conduct inspection of the Product in accordance with IceCure’s standard lot release testing methods approved by Terumo in writing. The Parties shall agree in good faith upon such standard lot release-testing methods prior to the Xxxxxx. IceCure shall send to Terumo a written certification of the results for each shipment. At Terumo costs and expenses, Terumo or its Affiliates shall conduct the incoming inspections and testing of the Product as set forth in the Specification Agreement or the Quality Agreement and as required by Applicable Laws and applicable Regulatory Authorities in the Territory and the Limited Territory. Terumo shall be responsible for final Product release testing for the Product in the Territory.
Release Testing. Pacira shall undertake, or have undertaken by the Third Party Manufacturer, Quality Control and Release of each Batch of the Finished Product using the analytical testing methodologies which are set forth in the Specifications and any Marketing Authorization and as required by cGMP and any other Applicable Laws.
Release Testing. Any Patches, Updates, Upgrades or other software developed as part of the Support and Maintenance Services will be tested to Cabot’s normal standards of software testing and will not undergo formal [Validation Testing]. If the Licensee requests that Cabot carry out Validation Testing of any released software then Cabot may do so at its sole discretion provided that the Licensee agrees to pay for this additional service at the rate set out in section 1.7. 26/06/2006 Page 41 of 47
Release Testing. If required, all Products supplied by Auxilium shall be tested and released by Auxilium in the EU until such time as Transfer of the Marketing Authorization occurs in at least one EU country and such Marketing Authorization is amended to identify Ipsen as the importer of the Product. Thereafter, if required, all Products supplied by Auxilium shall be tested and released in the EU by Ipsen, provided, ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. however, that Auxilium shall reimburse Ipsen for laboratory fees for such release testing not to exceed four hundred twenty-five pounds (£ 425) for the first batch of Product and three hundred fifty-five pounds (£ 355) for subsequent batches received in the same shipment. Testing and release of Product in non-EU countries, if required, shall be performed by Ipsen at its sole cost and expense.
Release Testing. Supplier shall perform release testing of all batches of Product in accordance with the Product Specifications and the Master Batch Record, to determine whether such batches of Product meet the requirements set out in the Product Specifications. Supplier shall ensure that:
Release Testing. Prior to release of the Products to finished goods inventory, WuXi Biologics shall test the Products in accordance with the testing procedures described in the Specifications.
Release Testing. The QLT will establish procedures for release testing EQW Product Manufactured for Lilly to ensure that EQW Product conforms to Applicable Laws.
Release Testing. The DWT will establish procedures for release testing of Devices Manufactured by Lilly to ensure that such Devices conform to Applicable Laws. *Confidential Treatment Request(ed)
Release Testing. Prior to release of the 89bio Products to finished goods inventory, Provider shall test the 89bio Products in accordance with the testing procedures described in the Specifications.
Release Testing. CBSH shall, from time to time as requested by SERAGEN, perform analytical release testing using validated procedures for First Gen FDP and Second Gen FDP according to SOPs. CBSH shall perform the work detailed in all SOPs under cGMP conditions, and shall perform the work as detailed in the SOPs within the time defined in the SOP, including laboratory testing, QA review of data and final report. In the event that SERAGEN requests a repeat of a test, and the request is in accordance with CBSH's retest policy, CBSH shall begin the work within one (1) week of the request, and complete the work within the time specified in the SOPs. In the event that analytical results fail to meet Specifications or acceptance criteria as defined in the SOPs or Manufacturing and Release Requirements, CBSH will undertake any resulting investigations and other action required as per cGMP and CBSH internal standard operating procedures or protocols. Any investigations other than those required by cGMP and/or CBSH internal standard operating procedures or protocols and if requested by SERAGEN will be performed in accordance with the Additional Services rates set forth in "Exhibit B." Although CBSH will be performing First Gen FDP and Second Gen FDP release testing, SERAGEN is, and at all times will remain, responsible for final release of the First Gen FDP and Second Gen FDP for sale and/or use. CBSH assumes no responsibility or liability whatsoever related to final release of First Gen FDP and Second Gen FDP for sale and/or use.
