Process Modifications Sample Clauses

The Process Modifications clause defines the procedures and conditions under which changes to established processes or workflows may be made during the course of an agreement. Typically, this clause outlines who has the authority to propose or approve modifications, the required notice period, and any documentation or approval steps necessary before changes take effect. By establishing a clear framework for altering processes, the clause helps ensure that all parties are informed and in agreement about operational changes, thereby reducing confusion and minimizing disputes related to unexpected or unilateral modifications.
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Process Modifications. BioGeneriX will not modify any process or procedure used in the manufacture of a Product without obtaining the prior consent of Neose, which shall not be unreasonably withheld or delayed.
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Process Modifications. Spark shall not be entitled to modify the process employed in the manufacture of the Product as set out in the DMF without first having consulted with Genable and then only with Genable’s prior written agreement and also in compliance with all applicable regulatory requirements in the United States and EU with respect to such modification.
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Process Modifications. JBI may make Process Modifications to any 214 Immunotherapeutic or Permitted Derivative Immunotherapeutic independently of Aduro, and without Aduro’s consent. Any Process Modifications developed independently by Aduro shall constitute Aduro Intellectual Property and will be disclosed to JBI by Aduro.
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Process Modifications. JBI may make Process Modifications to GVAX Licensed Therapeutic independently of Aduro, and without Aduro’s consent. Any Process Modifications developed independently by Aduro shall constitute Aduro Intellectual Property and will be disclosed to JBI by Aduro.
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Process Modifications. 14.1 Purepac shall not make any modifications to any of its manufacturing operations relating to the Product or to raw material sources that would require a modification to any Regulatory Document without the prior written consent of Alpharma which shall not be unreasonably withheld. Once a Regulatory Document has been filed with a Governmental Agency, Purepac agrees to take no action that would invalidate or otherwise jeopardize the information included in such Regulatory Document. 14.2 The Parties have agreed to a document (attached hereto as Appendix 6) which describes the necessary change control procedure and change control specifications to be followed, which cannot be changed unless both parties agree in writing.
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Related to Process Modifications

  • Cost Modifications The parties may agree to a reduction in the cost of the Contract at any time during which the Contract is in effect. Without intending to impose a limitation on the nature of the reduction, the reduction may be to hourly, staffing or unit costs, the total cost of the Contract or the reduction may take such other form as the State deems to be necessary or appropriate.

  • Contract Modifications It is understood that changes are inherent in operations of the type covered by this contract. The number of changes, the scope of those changes, and the impact they have on the progress of the original operations cannot be defined at this time. The PURCHASER is notified that changes are anticipated and that there will be no compensation made to the PURCHASER directly related to the number of changes made. Each change will be evaluated for extension of contract time and increase or decrease in compensation based on its own merit. STATE reserves the right to make, at any time during the contract, such modifications as are necessary or desirable; provided such modifications shall not change the character of the operations to be done nor increase the cost, unless such operations or cost increase is approved in writing by PURCHASER. Any modifications so made shall not invalidate this contract nor release PURCHASER of obligations under the performance bond. PURCHASER agrees to do the modified operations as if it had been a part of the original contract. If any change under this section causes an increase or decrease in the PURCHASER's cost of, or the time required for the performance of any part of the operations, the PURCHASER must submit a written statement setting forth the nature and specific extent of the claim. Such claim shall include all time and cost impacts against the contract and be submitted as soon as possible, but no later than 30 days after receipt of any written notice of modification of the contract. If the PURCHASER discovers site conditions which differ materially from what was represented in the contract or from conditions that would normally be expected to exist and be inherent to the activities defined in the contract, the PURCHASER shall notify the STATE's Authorized Representative immediately and before the area has been disturbed. The STATE's Authorized Representative will investigate the area and make a determination as to whether or not the conditions differ materially from either the conditions stated in the contract or those which could reasonably be expected in execution of this particular contract. If it is determined that a differing site condition exists, any compensation or credit will be determined based on an analysis by STATE's Authorized Representative. If the PURCHASER does not concur with the decision of the STATE's Authorized Representative and/or believes that it is entitled to additional compensation, the PURCHASER may proceed to file a claim. All claims shall be submitted in writing and shall include a detailed, factual statement of the basis of the claim, pertinent dates, contract provisions which support or allow the claim, reference to or copies of any documents which support the claim, the exact dollar value of the claim, and specific time extension requested for the claim. If the claim involves operations to be completed by subcontractors, the PURCHASER will analyze and evaluate the merits of the subcontractor's claim. PURCHASER shall forward the subcontractor's claim and PURCHASER's evaluation of such claim to STATE's Authorized Representative. The STATE's Authorized Representative will not consider direct claims from subcontractors, suppliers, manufacturers, or others not a party to this contract. The decision of the STATE shall be final and binding unless the PURCHASER requests mediation.

  • Custom Modifications In the event the Fund desires custom modifications in connection with its use of the System, the Fund shall make a written request to State Street providing specifications for the desired modification. Any custom modifications may be undertaken by State Street in its sole discretion in accordance with the Fee Schedule.

  • CONTRACT MODIFICATION The following is adopted as the new CTC for the Contract effective December 29, 2022:

  • Agreement Modifications No waiver, alteration or modification of any of the provisions of this Construction Services Agreement shall be binding upon either District or Contractor unless the same shall be in writing and signed by both District and Contractor.