PROCESS VALIDATIONS Sample Clauses

PROCESS VALIDATIONS. Meridian shall perform process validations of the manufacturing processes in accordance with the Specifications and all applicable laws in the Territory and shall make records of such validations. All costs and expenses necessary for such process validations which are required by the cGMPs shall be paid by Meridian. All costs and expenses necessary for such process validations which are not required by the cGMPs, but are requested by Dey xx required by any country in the Territory other than the United States in which Dey (xx a sub-distributor) is marketing, distributing or selling the Products or proposes to market, distribute or sell the Products, shall be paid by Dey. Xxridian shall make such validation records available to Dey xxx review at Meridian's manufacturing facility in accordance with Section 15a.
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PROCESS VALIDATIONS. Process Validations, e.g., Operational Qualification-Process (“OQ-P”) and PQ shall have approved protocols and test reports which include test data, results, date and signature of the individual(s) approving the validation and where appropriate the major equipment validated.

Related to PROCESS VALIDATIONS

  • Specifications That part of the Contract Documents consisting of written requirements for materials, equipment, systems, standards, and workmanship as applied to the Work, and certain administrative requirements and procedural matters applicable thereto. The term "Specifications" shall also include all written matter in the Project Manual or on the drawings and any Addenda or Change Orders thereto.

  • Inspection and Tests 3.8.1 The Procuring entity or its representative shall have the right to inspect and/or to test the goods to confirm their conformity to the Contract specifications. The Procuring entity shall notify the tenderer in writing in a timely manner, of the identity of any representatives retained for these purposes.

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Processes Any employer, employee, trade union or employer’s association may at any point in time apply for an exemption from any of the provisions of this Collective Agreement. The applicant is required to complete and submit in writing with the relevant office of the Council, a fully and properly completed prescribed application for exemption form, accompanied by all relevant supporting documentation.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • License Types The following License Types may be offered with respect to individual Software products or product families. Additional license types may be specified with respect to certain products or product groups as set forth in the Product Specific Terms. The License Type will be specified in an LSDA.

  • Solicitations for Subcontracts, Including Procurement of Materials and Equipment In all solicitation, either by competitive bidding or negotiation, made by the Contractor for work to be performed under a subcontract, including procurement of materials or leases of equipment, each potential Subcontractor or supplier shall be notified by the Contractor of the Contractor’s obligations under this Agreement and the Regulations relative to non-discrimination on the grounds of race, color, or national origin.

  • Third Party Components The Products and Services may contain third party components (including open source software) subject to separate license agreements. To the limited extent a third party license expressly supersedes this XXXX, such third party license governs Customer’s use of that third party component.

  • Solicitations for Subcontracts, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Engineer for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the Engineer of the Engineer's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin.

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