Process Specifications Sample Clauses

Process Specifications. With respect to each Process Supplement, Company shall deliver the technical specifications listed and described in the Process Supplement in accordance with the time schedule provided in such Process Supplement. Without limiting the foregoing, both Company and Foundry will contribute necessary technical resources and manpower for successfully establishing the Company Process at TSMC within the schedule set forth in such Process Supplement. The Parties agree to use commercially reasonable efforts to achieve the milestones or execute statements of work that may be identified in Process Supplements or as otherwise mutually agreed. Should there be any delay or delinquency, the Parties agree to negotiate, in good faith, for a commercially reasonable solution.
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Process Specifications. Following the Effective Date, LBIO shall provide the Process Specifications to Company and such Background Intellectual Property of LBIO as may be reasonably required by Company to perform the Services hereunder pursuant to a Statement of Work. For clarity, all right and title to and in such Process Specifications and LBIO’s Background Intellectual Property shall remain solely vested in LBIO.
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Process Specifications. From time to time, Iovance shall provide the Process Specifications to Company and such Background Intellectual Property of Iovance as may be reasonably required by Company to perform the Services hereunder pursuant to a Statement of Work. For clarity, all right and title to and in such Process Specifications and Iovance’s Background Intellectual Property shall remain solely vested in Iovance.
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Process Specifications. With respect to each Process Supplement, Spansion shall deliver the specifications listed and described in the Process Supplement in accordance with the time schedule provided in such Process Supplement. Without limiting the foregoing, SMIC will contribute necessary technical resources and manpower for successfully establishing the Spansion Process at SMIC within the schedule set forth in such Process Supplement. SMIC agrees to use its best efforts to achieve the milestones or execute statements of work that may be identified in Process Supplements or as otherwise mutually agreed. If SMIC fails to meet the scheduled dates or milestones in a Process Supplement, SMIC shall provide Spansion with a recovery plan to meet future scheduled dates or milestones.
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Process Specifications. The Manufacturing process for the Product complies with current specifications on the Effective Date, and has been successfully validated in accordance with GMP (if applicable), and finally approved by Valneva. Valneva and Xxxxxx shall agree in writing to the final Process Specifications for performance of any Services under this Agreement, and written documentation of such Process Specifications shall be attached to or referenced in the Quality Agreement and incorporated therein by reference. Valneva shall ensure that the Process Specifications comply with the Regulatory Approvals, Regulatory Filings and any applicable Legal Requirements. If the Valneva requires Xxxxxx to adhere to any additional good manufacturing practices of countries outside the Territory or any requirements coming from Valneva Legal Requirements, Regulatory Approvals, Regulatory Filings or any Product-specific GMP (either thereof “Additional Requirements”), any such Additional Requirements may be, after Xxxxxx review and by mutual prior written agreement of the Parties (including on regulatory, technical, commercial, quality and/or certain other provisions and documents applicable to such Products) be incorporated into the agreed Process Specifications. Valneva shall provide Xxxxxx Pharma with, included in any such request of Additional Requirements, the country-specific legislation, rules and regulations and practices or requirements of the regulatory authorities and governmental bodies, which may affect the Services (including the set-up, content and use of the CTD), the Manufacture and/or any Assistance, and shall inform Xxxxxx of the effect of any thereof. Valneva shall keep Xxxxxx informed of any changes of any thereof after the Effective Date and shall meet all notice and information requirements as set forth in the Quality Agreement. Valneva shall also provide Xxxxxx with all information reasonably necessary for the performance of the Services and any technical support reasonably requested by Xxxxxx in connection with the same. Xxxxxx shall keep Valneva informed of Xxxxxx’x positive knowledge, if any, of any specific legislation, rules and regulations and practices or requirements of the generally applicable regulatory requirements of German authorities, EMA and FDA, which may affect the set-up, content and use of the CTD, and shall inform Valneva of the effect thereof known to Xxxxxx. CONFIDENTIAL—DISCLOSURE PROHIBITED
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Process Specifications. The design of the Plant and Materials that forms part of the design for the works is required to conform to the following requirements:
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Process Specifications 
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Related to Process Specifications

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • 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.

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

  • Specification Changes Upon any change in the Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications (whether initiated by Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise sanofi-aventis in writing of such changes, and sanofi-aventis shall promptly advise Horizon as to any scheduling and/or price adjustments which may result from such changes. Prior to implementation of such changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Product Price for any Product which embodies such changes, (b) any amounts to be reimbursed by Horizon to sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). Horizon shall reimburse sanofi-aventis for the mutually agreed upon reasonable expenses incurred by sanofi-aventis as a result of such changes, including, but not limited to, reimbursing sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs, costs for any Packaging Components or other materials rendered unusable as a result of such changes, and cost of required stability to support a change. If during the Term Horizon amends the Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete quantities of the Active Ingredient, Excipients and/or Packaging Components for the Product on hand at sanofi-aventis, Horizon shall (i) accept the return of all such obsolete Active Ingredient and (ii) purchase from sanofi-aventis, at sanofi-aventis’ Acquisition Cost, all such obsolete Excipients and Packaging Components obtained by sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Product pursuant to Horizon forecasts under Section 6.1. Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of Excipients and Packaging Components corresponding to the immediately following […***…] months of Horizon’s most recent forecasted Product demand. If a change in Specifications is initiated by sanofi-aventis and approved by Horizon, any cost associated with said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the costs associated with qualification of the change shall be paid by Horizon. The amount of the change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (cGMP) destruction of any materials covered under this Article 5, and sanofi-aventis shall be reimbursed by Horizon at the reasonable and customary approved rate.

  • 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

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