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. 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. 7.1.1. Either Party may propose a discretionary change.
0.0.0. Xx the first instance, the Party proposing the discretionary change will discuss the proposal with the other Party.
7.1.3. If they wish to proceed, the Party proposing the discretionary change will then prepare a Notice of Change (NoC) accompanied, where appropriate, by a business case (a NoC template and business case template/checklist are provided at Annex E) for the consideration by the Parties and any relevant internal and external stakeholders .
0.0.0. Xx considering the proposed NoC, the Commissioner and/or HMPS and any relevant internal and external stakeholders may request further details or clarification to enable them to consider the proposed change.
7.1.5. The Party receiving the proposed NoC will respond to the Party proposing the change in an appropriate and timely way.
7.1.6. Having considered the responses the Commissioner will decide to: amend the SLA to include the proposed change, or; modify the proposed NoC, or; let the proposal lapse and take no further action.
7.1.7. The Commissioner will inform HMPS and any relevant internal and external stakeholders of the decision taken.
7.1.8. Where, after consultation, HMPS believes that a change will have a detrimental effect upon its delivery of the SLA and/or will result in additional costs above and beyond those provided for by NOMS, it may use the issue resolution process set out in Section
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. 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.
10.3.2 To the extent that a Discretionary Change requested by a Party increases the cost to the other Party or any of its Affiliates in providing or receiving the relevant Service (including, for the avoidance of doubt, the costs and appropriate margin of implementing the Discretionary Change and incremental running costs and appropriate margin arising as a result of that Discretionary Change), then:
(i) if the Party that requested the Discretionary Change or any Affiliate is the Recipient of the applicable Service, the increased cost and margin to the Provider of the Service will be added to the Charges paid by the Party for the relevant Service; or
(ii) if the Party that requested the Discretionary Change or any Affiliate is the Provider of the applicable Service, the increased cost to the Recipient of the Service will be deducted from the Charges paid by the Recipient for the relevant Service.
10.3.3 For the avoidance of doubt, the Party being requested to implement a Discretionary Change may refuse to implement any Discretionary Change.
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. 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 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 have an adverse impact on the Base Building Improvements, including the structural, 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 five (5) Business Days after the date Landlord receives Tenant’s request; provided, however, that Landlord’s response time will be extended by any need to obtain information or estimates from the Premises Contractor or any subcontractor as to time or cost for the proposed changes. If the change is requested less than five (5) Business Days before that portion of TI Work is scheduled to begin, Landlord shall make a reasonable effort to expedite its response but in no event shall Landlord be liable for failure to expedite its response. If Landlord approves such changes, then Tenant will provide Landlord with revised Working Drawings incorporating the changes within three (3) Business Days. If Tenant‘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, included Landlord’s lost rent attributable to such delay. Upon receipt of an Approval Notice, if Tenant still wishes the change to be made, Tenant shall so notify Landlord in writing within five (5) Business Days thereafter and if the reasonably estimated cost of such change exceeds Fifty Thousand Dollars ($50,000), shall deposit with Landlord any sum necessary to pay for such change whereupon Landlord shall execute a change order directing the Premises Contractor to make the approved changes. If the reasonably estimated cost of a change is less than or equal to Fifty Thousand Dollars ($50,000), the cost of such change shall be deposited with Landlord promptly after Tenant‘s receipt of its monthly statement of progress payments. If Tenant does not respon...
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.
