Equipment Validation Sample Clauses

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.
Sample 1
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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.
Sample 1
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. Exhibit 2.1-D
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1

Related to Equipment Validation

  • Equipment, Etc Each Grantor shall, (i) within ten (10) days after a written request by the Administrative Agent, in the case of Equipment now owned, and (ii) following a request by the Administrative Agent pursuant to subclause (i) above, within ten (10) days after acquiring any other Equipment, deliver to the Administrative Agent, any and all certificates of title, and applications therefor, if any, of such Equipment and shall cause the Administrative Agent to be named as lienholder on any such certificate of title and applications. No Grantor shall permit any such items to become a fixture to real estate or an accession to other personal property unless such real estate or personal property is the subject of a fixture filing (as defined in the UCC) creating a first priority perfected Lien in favor of the Administrative Agent.

  • Maintenance of Equipment The Equipment shall be maintained in good operating condition and repair (reasonable wear and tear excepted) and all necessary replacements of and repairs thereto shall be made so that the value and operating efficiency of the Equipment shall be maintained and preserved. No Borrower shall use or operate the Equipment in violation of any law, statute, ordinance, code, rule or regulation. Each Borrower shall have the right to sell Equipment to the extent set forth in Section 4.3 hereof.

  • Installation Tenant may install and use Tenant's Lines and make connections and disconnections at the terminal blocks as described above, provided Tenant shall: (i) obtain Landlord's prior written approval of all aspects thereof, (ii) use an experienced and qualified contractor designated or approved in writing in advance by Landlord (whom Landlord may require to enter an access and indemnity agreement on Landlord's then standard form of agreement therefor), (iii) comply with such inside wire standards as Landlord may adopt from time to time, and all other provisions of this Lease, including Paragraph 8 respecting alterations, and the Building rules respecting access to the wire closets, (iv) not install Lines in the same sleeve, chaseway or other enclosure in close proximity with electrical wire, and not install PVC-coated Lines under any circumstances, (v) thoroughly test any riser Lines to which Tenant intends to connect any Lines to ensure that such riser Lines are available and are not then connected to or used for telephone, data transmission or any other purpose by any other party (whether or not Landlord has previously approved such connections), and not connect to any such unavailable or connected riser Lines, and (vi) not connect any equipment to the Lines which may create an electromagnetic field exceeding the normal insulation ratings of ordinary twisted pair riser cable or cause radiation higher than normal background radiation, unless the Lines therefor (including riser Lines) are appropriately insulated to prevent such excessive electromagnetic fields or radiation (and such insulation shall not be provided by the use of additional unused twisted pair Lines). As a condition to permitting installation of new Lines, Landlord may require that Tenant remove any existing Lines located in or serving the Premises.

  • Spares Boeing will revise, as applicable, the customized Recommended Spares Parts List (RSPL) and Illustrated Parts Catalog (IPC).

  • Heating, Ventilation and Air Conditioning Landlord shall furnish to the Premises heating, ventilation and air-conditioning (“HVAC”) in accordance with the Design Standards set forth in Exhibit D during Ordinary Business Hours. Landlord shall have access to all air-cooling, fan, ventilating and machine rooms and electrical closets and all other mechanical installations of Landlord (collectively, “Mechanical Installations”), and Tenant shall not construct partitions or other obstructions which may interfere with Landlord’s access thereto or the moving of Landlord’s equipment to and from the Mechanical Installations. No Tenant Party shall at any time enter the Mechanical Installations or tamper with, adjust, or otherwise affect such Mechanical Installations. Landlord shall not be responsible if the HVAC System fails to provide cooled or heated air, as the case may be, to the Premises in accordance with the Design Standards by reason of (i) any equipment installed by, for or on behalf of Tenant, which has an electrical load in excess of the average electrical load and human occupancy factors for the HVAC System as designed, or (ii) any rearrangement of partitioning or other Alterations made or performed by, for or on behalf of Tenant. Tenant shall install, if missing, blinds or shades on all windows, which blinds and shades shall be subject to Landlord’s approval, and shall keep operable windows in the Premises closed, and lower the blinds when necessary because of the sun’s position, whenever the HVAC System is in operation or as and when required by any Requirement. Tenant shall cooperate with Landlord and shall abide by the rules and regulations which Landlord may reasonably prescribe for the proper functioning and protection of the HVAC System. Tenant acknowledges that the server room in the Premises currently has three heat pumps installed, being two 4-ton units, and one 2.5-ton unit (the “Existing Heat Pumps”). The 2.5-ton unit is currently connected and operational. Tenant shall determine whether it is satisfied with the condition of the Existing Heat Pumps and Landlord shall not have any responsibility or liability for the condition, operation, maintenance, repair or replacement of the Existing Heat Pumps. Tenant may operate the Existing Heat Pumps. Tenant shall be responsible for, and pay directly for, all necessary maintenance and repairs to the Existing Heat Pumps. Tenant shall reimburse Landlord monthly for the cost of all utility services used to operate the Existing Heat Pumps within 10 Business Days after receipt of Landlord’s invoice for such amount. Landlord may measure Tenant’s usage of such utility services by either a sub-meter or by other reasonable methods such as by temporary check meters or by survey. Tenant, at its cost, may replace the Existing Heat Pumps with one or more new heat pumps, provided, however, that the capacity of such replacement heat pump(s) shall not exceed the 10.5-ton capacity cooling capacity of the Existing Heat Pumps.

  • Commencement of Work Upon Contractor’s receipt from Owner of the limited notice to proceed (“Limited Notice to Proceed” or “LNTP”), Contractor shall promptly commence with the performance of the portion of the Work specified in such LNTP; provided that the Parties have executed a Change Order defining the LNTP Work. The LNTP shall be issued in the form attached hereto as Attachment H, Schedule H-1. Contractor shall not, and shall not be obligated to, commence performance of such Work until receipt from Owner of such LNTP.

  • Tooling Inventory that consists of tooling or replacement parts;

  • Maintenance of Aircraft Lessor shall be solely responsible for securing maintenance, preventive maintenance and inspections of the Aircraft (utilizing an inspection program listed in FAR Section 91.409(f)), and shall take such requirements into account in scheduling the Aircraft hereunder.

  • Maintenance of Licenses The Owner Trustee will obtain and maintain any licenses that the Administrator informs the Owner Trustee are required to be obtained or maintained by the Owner Trustee under the laws of any State in connection with the Owner Trustee’s duties and obligations under the Transaction Documents.

  • Equipment and Supplies Independent Contractor, at Independent Contractor's sole expense, shall provide all equipment, tools and supplies necessary to perform the Service.

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