Changes in Production Sample Clauses

The "Changes in Production" clause defines the procedures and rights related to modifying the scope, process, or specifications of a production project after an agreement has been made. Typically, this clause outlines how either party can propose changes, the process for evaluating and approving such changes, and any adjustments to timelines, costs, or deliverables that may result. For example, if a client requests additional scenes or alterations to the original plan, this clause would govern how those requests are handled and how compensation or deadlines might be adjusted. Its core function is to provide a structured method for managing and documenting changes, thereby reducing disputes and ensuring both parties understand the implications of any modifications.
Changes in Production. Nephron shall inform RevitaLid within fifteen (15) days of the result of any development that directly affects Production or changes to the Product- specific Nephron SOPs. Nephron shall give written notice to RevitaLid of any such changes, and RevitaLid and Nephron will review such development or changes in accordance with the Quality Agreement. Nephron shall assure that all such changes to the Product-specific Nephron SOPs are consistent with the Product Master Plan unless the Parties otherwise expressly agree in writing. Nephron shall only make changes to the Product Master Plan that are in accordance with Section 4.2.
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Changes in Production. AVID shall inform HALOZYME within fifteen (15) calendar days of the result of any development that directly affects the Production of the Bulk Drug Substance or changes to Bulk Drug Substance-specific AVID SOPs. AVID shall give written notice to HALOZYME of any such changes, and HALOZYME and AVID will review such development or changes in accordance with the Quality Agreement. AVID shall assure that all such changes to the Bulk Drug Substance-specific AVID SOPs are consistent with the Bulk Drug Substance Master Plan unless the parties otherwise expressly agree in writing. AVID shall only make changes to the Bulk Drug Substance Master Plan that are in accordance with Section 2.2.
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Changes in Production. If Supplier determines it necessary, prudent or desirable to make any change to materials, processes, sources or equipment, and if such change is material to the API and/or the DMF, Supplier will notify Customer of such change [***] prior to making such change. In such cases, Customer reserves the right to increase Forecasts (including Firm Periods) and issue additional or revise Purchase Orders reflecting such updated Forecasts in order to increase ordered quantities of API in order to obtain safety stock; provided that Supplier shall use commercially reasonable efforts to satisfy but shall have no obligation to fulfill any orders for quantities in excess of [***] of the amount forecasted in the original Forecast.
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Changes in Production. 8.1 Changes to Master Batch Records and Specifications: ▇▇▇▇▇▇ agrees to inform Client within [***] of the result of any regulatory development or changes to Client Product-specific ▇▇▇▇▇▇ SOPs that materially affect the Production of Client Product. ▇▇▇▇▇▇ shall notify Client of and require written approval from Client for changes to Master Batch Records and Client Product Specifications prior to the Production of subsequent Batches of Client Product. 8.2 Product-Specific Changes: If facility, equipment, process or system changes are required of ▇▇▇▇▇▇ as a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply only to the Production and supply of one or more Client Products, then Client and ▇▇▇▇▇▇ will review such requirements and agree in writing to such regulatory changes, [***]. ▇▇▇▇▇▇ & ALDER CONFIDENTIAL 14 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 8.3 General Changes: If such regulatory changes apply generally to the Client Product as well as to other products produced by ▇▇▇▇▇▇ for itself or for third parties, then [***]. If the regulatory change is of such a nature that it applies to contract manufacturers providing services of the type provided generally by ▇▇▇▇▇▇ and ▇▇▇▇▇▇ may not offer certain services to Client under this Agreement as a result, [***].
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Changes in Production 
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Related to Changes in Production

  • Changes in Business Neither the Borrower nor any of its Subsidiaries will engage in any business if, as a result, the general nature of the business, taken on a consolidated basis, which would then be engaged in by the Borrower and its Subsidiaries, would be substantially changed from the general nature of the business engaged in by the Borrower and its Subsidiaries on the Closing Date.

  • Changes in GAAP If at any time any change in GAAP would affect the computation of any financial ratio or requirement set forth in any Loan Document, and either the Borrower or the Required Lenders shall so request, the Administrative Agent, the Lenders and the Borrower shall negotiate in good faith to amend such ratio or requirement to preserve the original intent thereof in light of such change in GAAP (subject to the approval of the Required Lenders); provided that, until so amended, (i) such ratio or requirement shall continue to be computed in accordance with GAAP prior to such change therein and (ii) the Borrower shall provide to the Administrative Agent and the Lenders financial statements and other documents required under this Agreement or as reasonably requested hereunder setting forth a reconciliation between calculations of such ratio or requirement made before and after giving effect to such change in GAAP.

  • MINOR CHANGES IN THE WORK If permitted in the agreement between Owner and Architect, the Architect has authority to order minor changes in the Work not involving adjustment in the Contract Sum or extension of the Contract Time and not inconsistent with the intent of the Contract Documents.

  • Changes in the Work The Department may order changes in the work, the Contract Amount being adjusted accordingly. Any monetary adjustment or any substantive change in the work shall be in the form of an amendment, signed by both parties and approved by the State Purchases Review Committee. Said amendment must be effective prior to execution of the work.

  • Changes in Work The Contractor shall not commence any additional work or change the scope of the work until authorized in writing by the State. The Contractor shall make no claim for additional compensation in the absence of a prior written approval and amendment executed by all signatories hereto. This Contract may only be amended, supplemented or modified by a written document executed in the same manner as this Contract.