Equipment Validation. Patheon shall perform qualification and validation activities for any Equipment used to Manufacture the Product. Preparations and review of protocols and reports associated with all the planned qualification/validation activities are included. Patheon shall perform Equipment trial to confirm compliance of the Equipment with GMP. The trial would follow the Patheon standard approach. Patheon shall perform Container Closer Integrity testing; vials will be tested using media filled units. Patheon shall perform qualification and validation of the following processes to ensure sterility assurance with protocols and reports prepared: • Stopper sterilization • Vial washing machine and depyrogenation tunnel • Environmental control Cleaning Process Verification/Validation All Equipment will be dedicated and the current cleaning procedures employed by Pacira will meet the regulatory and internal requirements of the Patheon Swindon facility. It is assumed that a validated cleaning test method is available and will be transferred into Patheon laboratories and also that full cleaning occurs after each campaign (where applicable). [**] - Indicates certain information has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the redacted portions.
Equipment Validation. (a) [*****] and [*****] Services. The Parties acknowledge and agree that: (i) the [*****] services contemplated by Section 3.3 of the Agreement are complete and have been approved and accepted by Altus, for a total value of services performed equal to [*****]; and (ii) the [*****] services contemplated by Section 3.3 of the Agreement are ongoing as of the Second Amendment Date, for a total value of services performed (when such [*****] services are completed) equal to [*****]. Axxxxx acknowledges receipt of payment in full (i.e., [*****]) for the [*****] services contemplated by Section 3.3 of the Agreement.
(b) [*****] Services. The Parties hereby agree that the payment previously made by Altus pursuant to Section 5.2 of the Agreement for [*****] services that were to be provided by Axxxxx, in the amount of [*****], shall be [*****], to [*****] that may be payable by Altus under the Agreement after the Second Amendment Date. The Parties further agree that Axxxxx shall have no further obligation to perform [*****] services as contemplated by Section 3.3 of the Agreement, and Altus shall have no further obligation to pay for such [*****] services, except as expressly agreed by the Parties in a change order entered into after the Second Amendment Date.
Equipment Validation. CYTOVANCE shall qualify equipment according to CYTOVANCE procedures, CYTOVANCE shall notify CLIENT QA of any proposed changes to process equipment used in production of CLIENT product to assure appropriate impact assessment on CLIENT Product. Copies of validation/qualification reports will be made available for CLIENT review during site audit or upon request.
Equipment Validation. Xxxxxx shall conduct the manufacturing equipment acceptance and preliminary validation processes (IQ, OQ, PQ and Cleaning Validation), all as provided in the Project Plan. Such work shall commence as promptly as practicable following the completion of the installation of the Equipment (as below). Altus shall provide to Xxxxxx (on loan) the equipment specified in Schedule 2 hereto (the "Equipment") for crystallization and formulation of Drug Product and shall provide support to Xxxxxx for validation of the Equipment. The Equipment shall remain the property of Altus and shall be returned to Altus at the end of this Agreement or upon early termination of this Agreement. Following written notice by Altus to Xxxxxx that the Equipment is subject to a third party lien or other encumbrance resulting from a financing arrangement, Xxxxxx agrees to provide such third party with access to the Equipment as necessary for such third party to exercise its rights under such financing arrangement. Altus shall be responsible for insuring the equipment against loss or damage. Xxxxxx shall use commercially reasonable efforts to maintain the Equipment in good working order and to avoid damage or harm to the Equipment. If Altus or a third party is required to visit the Facility to perform service, repair or maintenance of the Equipment, or if such service, repair or maintenance requires the purchase of spare parts, Altus shall be responsible for the cost thereof (which shall be in addition to the payment amounts set forth in this Agreement), PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934. except to the extent that Althea's negligence or willful misconduct or other failure to comply with its obligations under this Agreement result in the need for such service, repair, maintenance or parts, in which case Xxxxxx shall bear full responsibility for all such costs and expenses.
Equipment Validation. Supplier will be responsible for completing/managing the installation and validation of the Equipment, including the computerized system validation, as applicable, according to the Target Completion Date(s) covered in Section 11.1. All validation activities will be completed prior to cGMP manufacturing.
Equipment Validation. Dynavax shall be responsible for operating and maintaining the Facility, the Pilot Facility and equipment, validating the equipment (including without limitation conducting installation, operational and performance qualification), production, cleaning, packaging, process and any other appropriate steps performed at the Facility or Pilot Facility in accordance with (a) cGMPs and (b) Dynavax’s standard operating procedures.
