Maintenance; Validation Sample Clauses

Maintenance; Validation. NASTECH agrees, at its expense, to operate and maintain the FACILITY and all equipment used, directly or indirectly, to MANUFACTURE PRODUCT in accordance with cGMPs and all applicable laws and regulations and REGULATORY AUTHORITY requirements and to maintain said FACILITY and equipment in an acceptable state of repair and operating efficiency so as to meet the SPECIFICATIONS and comply with the NASTECH KNOW-HOW. NASTECH shall be responsible for 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 in accordance with the NASTECH KNOW-HOW. Validation procedures presently used by NASTECH may be used; provided, such procedures (i) are found acceptable to MERCK, (ii) meet applicable regulatory requirements, and (iii) are found acceptable by REGULATORY AUTHORITY inspectors, if applicable. If MERCK or any REGULATORY AUTHORITY finds NASTECH's validation procedures to be unacceptable, then all [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] validation must be repeated to meet all applicable regulatory requirements and guidelines and to receive all REGULATORY AUTHORITY approvals.
Sample 1
AutoNDA by SimpleDocs
Maintenance; Validation. MERCK agrees to operate and maintain (and cause its Affiliates and Approved Manufacturers to operate and maintain) the MERCK Manufacturing Facilities and all equipment used, directly or indirectly, to Manufacture Clinical Product, Marketed Product or MERCK Product in accordance with the Specified Regulatory Requirements, and to maintain (and cause its Affiliates and Approved Manufacturers to maintain) said Facilities and equipment in an acceptable state of repair and operating efficiency so as to meet the applicable Specifications and comply with the Specified Regulatory Requirements. MERCK shall validate and maintain the validation of (or cause its Affiliates and Approved Manufacturers to validate and maintain) the Facilities, the equipment (including without limitation conducting installation, operational and performance qualification), production, cleaning, packaging, process and any other appropriate steps performed at the MERCK Manufacturing Facilities.
Sample 1
Maintenance; Validation. ARIAD agrees to operate and maintain (or cause its Affiliates and Approved Manufacturers to operate and maintain) the ARIAD Manufacturing Facilities and all equipment used, directly or indirectly, to Manufacture API and Clinical Product in accordance with the Specified Regulatory Requirements, and to maintain (and cause its Affiliates and Approved Manufacturers to maintain) said Facilities and equipment in an acceptable state of repair and operating efficiency so as to meet the applicable Specifications and comply with the Specified Regulatory Requirements. ARIAD shall validate and maintain the validation of (or cause its Affiliates and Approved Manufacturers to validate and maintain) the Facilities, the equipment (including, without limitation, conducting installation, operational and performance qualification), production, cleaning, packaging, process and any other appropriate steps performed at the ARIAD Manufacturing Facilities.
Sample 1
Maintenance; Validation. NASTECH agrees, at its expense, to operate and maintain the FACILITY and all equipment used, directly or indirectly, to MANUFACTURE PRODUCT in accordance with cGMPs and all applicable LAWS and regulations and REGULATORY AUTHORITY requirements and to maintain said FACILITY and equipment in an acceptable state of repair and operating efficiency so as to meet the SPECIFICATIONS and comply with the PRODUCT KNOW-HOW. NASTECH shall be responsible for 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 in accordance with the PRODUCT KNOW-HOW. Validation procedures presently used by NASTECH may be used; provided, such procedures (i) are found acceptable to P&GP, (ii) meet applicable regulatory requirements, and (iii) are found acceptable by REGULATORY AUTHORITY inspectors, if applicable. If P&GP or any REGULATORY AUTHORITY finds NASTECH's validation procedures to be unacceptable, then all validation must be repeated in a timely manner to meet all applicable regulatory requirements and guidelines and to receive all REGULATORY AUTHORITY approvals.
Sample 1
Maintenance; Validation. SURMODICS agrees, at its expense, to operate and maintain (or to cause its applicable Contract Manufacturer to operate and maintain) the Facilities and all equipment used, directly or indirectly, to Manufacture Product in accordance with cGMPs and all applicable laws and regulations and Regulatory Authority requirements and to maintain (or cause to be maintained) said Facilities and equipment in an acceptable state of repair and operating efficiency so as to meet the Specifications and comply with the SURMODICS Know-How. SURMODICS shall be responsible for validating (or causing its Contract Manufacturer to validate) the equipment (including without limitation conducting installation, operational and performance qualification), production, cleaning, packaging, processing and any other appropriate steps performed at the Facilities. Validation procedures used by SURMODICS (or its Contract Manufacturers) as of the Effective Date may continue to be used by SURMODICS (or its Contract Manufacturers); [*]
Sample 1

Related to Maintenance; Validation

  • Maintenance of Status The Borrower will maintain its separate corporate existence and remain in good standing under the laws of the Xxxxxxxx Islands.

  • Maintenance All costs for maintaining, operating, replacing, repairing, white-washing, painting, decorating, re-decorating, re-building, re-constructing, lighting and renovating the Common Areas [including the exterior or interior (but not inside any apartment) walls of the Said Block/Building] and the road network, STP etc.

  • MAINTENANCE AND INSPECTION OF COLLATERAL Grantor shall maintain all tangible Collateral in good condition and repair. Grantor will not commit or permit damage to or destruction of the Collateral or any part of the Collateral. Lender and its designated representatives and agents shall have the right at all reasonable times to examine, inspect, and audit the Collateral wherever located. Grantor shall immediately notify Lender of all cases involving the return, rejection, repossession, loss or damage of or to any Collateral; of any request for credit or adjustment or of any other dispute arising with respect to the Collateral; and generally of all happenings and events affecting the Collateral or the value or the amount of the Collateral.

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • 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.

  • Maintenance of Liens Each Borrower shall perform all such acts and execute all such documents as Administrative Agent may reasonably request in order to enable Administrative Agent and the Lenders to file and record every instrument that Administrative Agent may reasonably deem necessary in order to perfect and maintain Administrative Agent’s first priority Liens on the Collateral (subject to Permitted Liens).

  • Maintenance of Agencies (a) With respect to each series of Certificates, there shall at all times be maintained an office or agency in the location set forth in Section 12.04 where Certificates of such series may be presented or surrendered for registration of transfer or for exchange, and for payment thereof, and where notices and demands, to or upon the Trustee in respect of such Certificates or this Agreement may be served; provided, however, that, if it shall be necessary that the Trustee maintain an office or agency in another location with respect to the Certificates of any series (e.g., the Certificates of such series shall be represented by Definitive Certificates and shall be listed on a national securities exchange), the Trustee will make all reasonable efforts to establish such an office or agency. Written notice of the location of each such other office or agency and of any change of location thereof shall be given by the Trustee to the Company, any Owner Trustees, the Loan Trustees (in the case of any Owner Trustee or Loan Trustee, at its address specified in the Note Documents or such other address as may be notified to the Trustee) and the Certificateholders of such series. In the event that no such office or agency shall be maintained or no such notice of location or of change of location shall be given, presentations and demands may be made and notices may be served at the Corporate Trust Office of the Trustee.

  • Maintenance and Support For so long as you timely pay your SaaS Fees according to the Invoicing and Payment Policy, then in addition to the terms set forth in the SLA and the Support Call Process, we will:

  • Property Maintenance Maintain all of its property that is necessary to or useful in the proper conduct of its business in good working condition, ordinary wear and tear excepted.

Time is Money Join Law Insider Premium to draft better contracts faster.