Change to Specifications. Salix in its sole discretion shall have the right to change the Specifications and the process of Manufacturing Generic Product from time to time; provided that Salix shall give Xxxxxx reasonable (under the circumstances) advance notice of any such change. Salix shall not be required to make any change to the Specifications or the process of Manufacturing Generic Product requested by Xxxxxx. The costs associated with all changes to the Specifications or the process of Manufacturing Generic Product shall be borne by Salix unless such change was requested by Xxxxxx and approved by Salix, in which event Xxxxxx shall bear all of such costs.
Change to Specifications. TI has the right to modify, change or alter the Specifications from time-to-time, at its sole discretion and upon reasonable written notice to Anam. In the event TI makes a change to the Specifications, the Parties, through good faith negotiations, shall agree upon the delivery schedule of the TI Products resulting from said change and TI's and Anam's respective responsibilities, in accordance with Section 3.02 for the costs incurred by Anam in connection with such changes, within thirty (30) days following any such notice. All Specification changes shall be consistent with TI's own Specification changes and shall not require Anam to perform changes not otherwise generally performed by TI with respect to comparable process flows under comparable circumstances.
Change to Specifications. In its sole discretion, AstraZeneca shall have the right, at its cost and expense, to make modifications to the specifications or Manufacturing processes employed with regard to the Manufacture of the Supplied Products from time to time, subject to such modifications being approved by the FDA to the extent required by Applicable Law. For clarity, Impax shall have no right to change specifications or Manufacturing process for any Supplied Product that is supplied by AstraZeneca, its Affiliates or a Third Party Manufacturer.
Change to Specifications. In the event of a proposed change by either party in the Specifications during the Term, the proposing party shall promptly notify the other party of the proposed change, and shall provide the other party with documentation in support of such proposed change and within a period of ten (10) business days from receipt of such notice, the parties shall initiate review and comment on such proposed change. MSD IRELAND and GUILFORD shall cooperate in good faith to design a plan to resolve any Supplied Product supply issues that may result from changes in the Specifications, and while MSD *The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission. IRELAND is Manufacturing the Supplied Product hereunder, no change will be made without the written mutual agreement of both parties, such agreement not to be unreasonably withheld, except as required by Applicable Laws. Beginning on the Effective Date, GUILFORD shall obtain all necessary and appropriate regulatory approvals prior to making any agreed upon change or any change required by Applicable Law or regulatory action. MSD IRELAND shall provide GUILFORD with necessary revisions to the Specifications (as well as supporting data) as so changed prior to shipment of any Supplied Product Manufactured using such revised Specifications. Subject to the foregoing, if MSD IRELAND makes a change to the Manufacturing process or Specifications and both parties agree the change can be filed in the Annual Report, MSD IRELAND shall provide the data to GUILFORD prior to submission of the Annual Report. All costs associated with any such change shall be borne as agreed by the parties.
Change to Specifications. Buyer may, effective upon notice to Seller, make changes to Buyer’s designs, drawings or specifications at any time prior to shipment of corresponding Products covered by this Order. If any such change directly results in an increase or decrease in prices or delivery schedules of Products, then an equitable adjustment shall be made, provided that Seller makes and Buyer accepts a written claim for an adjustment prior to shipment of Products. If the parties are unable to agree upon the amount of the adjustment, Buyer may, without any liability to Seller, terminate this Order as to all Products affected. Seller shall not, without the prior written consent of Buyer, make any changes to: (a) the process, materials, procedures or equipment related to manufacture or supply of the Products; or (b) the designs, drawings or specifications affecting Products.
Change to Specifications. Teligent Estonia shall have the right, at its cost and expense, to modify the specifications, labeling, Manufacturing and testing processes employed with regard to the Manufacture of the Product from time to time, subject to such modifications being approved by the Regulatory Authorities to the extent required by Law.
Change to Specifications. ELAN shall be entitled to request a change to the Specifications from time to time (which change is not the result of a requirement or mandate of a Regulatory Authority) and BI Pharma shall make and implement all such changes in accordance with the applicable Quality Agreement, ELAN’s change control procedures, and a written implementation plan (including tasks, time and cost) agreed to by the Project Team. ELAN shall retain the right and responsibility for final approval of the Specifications and any changes made thereto.
Change to Specifications. 6.1 MSK may notify the Supplier in writing of any change in the desired specification (including as to the quality and time frame).
Change to Specifications. The Parties acknowledge and agree that the Product Specifications and Fulfillment Specifications are subject to change by mutual agreement of FreshRealm and Blue Apron. If either Party desires to change the Product Specifications or Fulfillment Specifications (“Specification Change”), it will communicate the same to the other Party (“Specification Change Request”). Shortly after receipt or delivery of the Specification Change Request, FreshRealm will communicate the impact to the Product price (“Price Impact”). After FreshRealm has communicated any Price Impact, Blue Apron may approve such Price Impact or the Parties may negotiate in good faith in respect thereof, prior to the Specification Change Request being put into place. Upon mutual agreement, which neither Party will unreasonably withhold, condition or delay, FreshRealm will implement the Specification Change in a commercially reasonable matter and timeline and will prepare any samples necessary for Blue Apron to approve Product made with such Specification Change. FreshRealm will not implement any Specification Change until Blue Apron has approved Products made with the Specification Change and the Parties have agreed on any Price Impact.
Change to Specifications. If a Competent Authority requires any change to the Specifications or Atrix's quality assurance procedures that would render Atrix unable to supply the Product or Professional Samples in accordance with the terms of this Agreement, Atrix shall promptly (but in no event more than five Business Days after receipt of notice whether verbal or written) notify Fujisawa in writing of any changes required. Any such notice to Fujisawa shall be accompanied by any relevant supporting -------- ** Confidential Treatment Requested 24 documentation and copies of reports, communications and correspondence from or to any such Competent Authority. The Parties agree to develop and execute an appropriate action plan in such situation. Any additional costs or expenses in connection with a required change (i) to Atrix's quality assurance procedures, shall be borne []** and (ii) to the Specifications for Packaging or Labeling, shall be borne []** Any other changes to Specifications not required by a Competent Authority shall be mutually agreed to by the Parties and any costs in connection with any such change shall be borne []**
