Discretionary Changes. 10.3.1 Where a Change Control Request submitted by a Party is in respect of a Discretionary Change, the Parties shall, as soon as reasonably practicable thereafter, meet to discuss the terms of the Discretionary Change, including the payment of costs incurred by the Provider associated with the proposed Discretionary Change. For the avoidance of doubt, the Party being requested to implement a Discretionary Change may refuse to implement any Discretionary Change.
Discretionary Changes. Seller shall consider in good faith any request by Buyer to make changes to the Product Specifications or Manufacturing that are not Required Changes, including, but not limited to, changes to the existing Product, Product line extensions, or changes to the existing or additional packaging (collectively, “Discretionary Changes”). Any analytical improvements shall be considered Discretionary Changes unless requested or required by Regulatory Authorities in which case such improvements shall be considered a Required Change. Any change requested by Seller which is not a Required Change shall be made only with the written consent of the Buyer, which consent shall not be unreasonably withheld.
Discretionary Changes. With respect to changes to the Specifications or to any process involved in the manufacture, Packaging, Labeling, storage, transportation, delivery or testing of the Product that are not required by Applicable Laws or by mandate of an applicable government authority (including the FDA), the parties shall cooperate in good faith to reach a mutually agreeable solution with regard to such changes, but Seller shall not be obligated to make any such changes requested by Purchaser except as expressly provided in Section 6.2.3. Seller reserves the right to make such changes unilaterally; provided, however, that Seller will consult with Purchaser prior to making such changes; and provided further that, Seller shall obtain Purchaser’s prior written consent (which will not be unreasonably withheld or delayed) for any changes that would materially affect storage or transportation of the Product after delivery to Purchaser. The cost of making a discretionary change shall be borne solely by the party initiating the change or as otherwise mutually agreed to in writing by the parties. In the event any such changes initiated by Purchaser increase Seller’s costs of manufacturing and supplying the Product to Purchaser, at Seller’s request, the parties shall discuss and agree in good faith to an equitable adjustment of the Unit Price to account for such increase in costs.
Discretionary Changes. 7.1.1.Either Party may propose a discretionary change.
Discretionary Changes. Subject to Section 4.3(b), in the event that either Party desires to change, revise, modify or otherwise alter the Specifications, manufacturing processes, Product Materials, Buy-Sell Materials, Customer-Supplied Materials, or Facilities with respect to a given Product in any manner (each, a “Manufacturing Change”), the Party desiring the Manufacturing Change shall notify the other Party in writing of the proposed Manufacturing Change and the Parties will promptly meet to discuss, in good faith, the feasibility of implementing such Manufacturing Change and the allocation of costs between the Parties for such Manufacturing Change; provided that the requested Manufacturing Change will not be implemented unless and until the Parties mutually agree in writing to implement such Manufacturing Change. Unless otherwise agreed upon by the Parties, the Party requesting the Manufacturing Change will be responsible for, and will bear the costs of, any filings or other actions that either Party must take with the applicable Governmental Authority as a result of such Manufacturing Change.
Discretionary Changes. Either Party may from time to time request a change to the Specifications or Manufacturing Process that does not constitute a Required Change, including, but not limited to, changes to the existing Products, Product line extensions, changes in Product labeling or changes to the existing or additional packaging (each, a “Discretionary Change”). In the event that a Party requests a Discretionary Change, the Parties shall meet and discuss the proposed Discretionary Change in accordance with Section 4.5(a) or at such other times as the Parties reasonably agree. Any analytical improvements shall be considered Discretionary Changes unless requested or required by any Governmental Authority in which case such improvements shall be considered a Required Change. In the event that the Parties agree to a Discretionary Change, the Party requesting such Discretionary Change shall be responsible for all incremental costs incurred to implement such Discretionary Change and which costs may include, costs of capital equipment and process upgrades and of obsolescence of Materials, goods-in-process, and finished goods not suitable for use in the business or operations of Manufacturer or any of its Affiliates; provided, however, that Purchaser’s liability for such reimbursement shall be limited to levels of inventory that are consistent with the most recent Rolling Forecast. Any costs subject to reimbursement pursuant to this Section 4.4(c) shall be paid in accordance with the provisions of Section 4.4(d).
Discretionary Changes. If Tenant desires to change or revise the --------------------- Tenant Improvements specified by the approved TI Working Drawings, then Tenant shall submit such change in writing for Landlord's approval, which shall not be unreasonably withheld, conditioned or delayed and such request shall be accompanied by plans, specifications and details as may be required to fully identify and quantify such changes. Landlord shall not be required to approve any modifications if, in Landlord's judgment such modification would delay completion of the Base Building Improvements or have an adverse impact on the mechanical, electrical, life safety or HVAC systems in the Building. Landlord shall notify Tenant in writing (an "Approval Notice") whether it will approve the requested change within ten (10) Business Days after the date Landlord receives Tenant's request; provided, however, that Xxxxxxxx's response time will -------- ------- be extended by any need to obtain information or estimates from the TI Contractor or any subcontractor as to time or cost of the proposed changes. If the change is requested less than ten (10) Business Days before that portion of Landlord's Work is scheduled to begin, Landlord shall make a reasonable effort to expedite its response. If Landlord approves such changes, then Tenant will provide Landlord with revised Working Drawings incorporating the changes. If Xxxxxx's request will increase the cost of construction or will cause a delay in completing the construction, Landlord's Approval Notice shall include Landlord's good faith estimate of the amount of delay it will cause and/or the increased costs associated with the change. Upon receipt of an Approval Notice, if Tenant still wishes the change to be made, Tenant shall so notify Landlord in writing within three (3) Business Days thereafter and shall pay Landlord any sum necessary to pay for such change whereupon Landlord shall execute a change order directing the TI Contractor to make the approved changes. If Tenant does not respond and increase the Construction Payment within three (3) Business Days then it shall be deemed to have withdrawn its request. Landlord shall be entitled to its administrative fee for overseeing the change order. If, incident to a requested change to the Working Drawings or Landlord's Work, Landlord stops work pending resolution of whether Tenant finally approves or disapproves the additional costs or delay of a proposed change, then whether or not Tenant ultimatel...
Discretionary Changes. Either Party may submit to the other Party written proposals of changes to the manufacturing and production process for the Products other than Mandatory Changes (collectively, “Discretionary Changes”). Manufacturer shall implement Discretionary Changes upon the written consent of the non-requesting Party, which consent shall not be unreasonably withheld, conditioned or delayed.
Discretionary Changes. In the event that either Party desires to propose any Technical Change not required by cGMPs or other Applicable Laws during the Term (a “Discretionary Manufacturing Change”), the Parties shall discuss such Discretionary Manufacturing Change and any Manufacturing issues identified by either Party in connection with implementing such change. In all cases, such Discretionary Manufacturing Change shall be made in accordance with the change control provisions set forth in the Quality Agreement. Notwithstanding the foregoing, in all cases, the Specifications may be amended or supplemented from time to time by Client, at Client’s cost, upon written notice to WuXi Biologics in accordance with any change control procedures in the Quality Agreement and at Client’s costs.
Discretionary Changes. (a) From time to time during the Manufacturing Term, either Party may submit to the other Party written proposals for Discretionary Changes. The proposed Discretionary Change shall be implemented only with the written consent of the other Party. For the avoidance of doubt, J&J shall agree to and implement a Discretionary Change proposed by Kenvue if such change solely relates to the company information on the Product packages or labels and would not reasonably be expected to delay the timeline, as set forth in the Tech Transfer Plan, for the transfer of Manufacture of the applicable Product to Kenvue’s own manufacturing facilities or to an applicable qualified alternative third party Supplier. Any Discretionary Changes shall be made in accordance with the Quality Agreement, including any applicable Change Control process, and Kenvue shall provide J&J with any information needed to duly implement any Discretionary Change approved by Kenvue. J&J and Kenvue shall use commercially reasonable efforts and cooperate in good faith to resolve any Product supply issues that may result from a Discretionary Change and minimize any delays in Manufacturing Services or delivery of Product resulting therefrom; provided that, if J&J is in compliance with its obligations pursuant to this sentence, J&J and its Affiliates shall have no liability for any delays in Manufacturing Services or delivery of Product attributable to supply issues that result from a Discretionary Change.
