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. ENDOCEUTICS warrants that the Manufacturing Process and the Specifications comply with Applicable Law and the Marketing Authorization. No change in the Specifications shall be binding upon ENDOCEUTICS without its prior written consent, not to be unreasonably delayed, withheld or conditioned. AMAG may propose changes to the Specifications by delivering a written notice to ENDOCEUTICS of such proposed changes. ENDOCEUTICS shall promptly notify AMAG in writing of ENDOCEUTICS’ good faith and reasonable determination as to whether: (i) ENDOCEUTICS is technically able to comply with such proposed changes, and (ii) the extent (if any) to which applicable PRODUCT Price would increase or decrease as a result of such proposed changes. ENDOCEUTICS may propose changes to the Specifications and/or the Manufacturing Process by delivering a written notice to AMAG of such proposed changes indicating the extent (if any) to which the PRODUCT Price would increase or decrease as a result of such changes. Promptly following AMAG’s receipt of a notice of any ENDOCEUTICS proposed change, the Parties shall meet and discuss such proposed change(s) in good faith and agree on whether to implement such change and the implementation strategy for such change, provided that in the absence of agreement, [***]. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Notwithstanding the foregoing, if a change to the Specifications is required by a Regulatory Authority for the Territory or for any other country in which the PRODUCT is Manufactured or in order to comply with Applicable Law, the Parties shall cooperate and use commercially reasonable efforts to implement such change as soon as reasonably practicable. If the implementation of any Specification change or Manufacturing Process change requires any submission or communication with any Regulatory Authority, then [***]. For clarity, AMAG shall be the party responsible for submitting any proposed change to the FDA and shall keep ENDOCEUTICS fully informed of Regulatory Authority review, and approval of submissions and any communications with Regulatory Authorities regarding any such change. If AMAG and ENDOCEUTICS agree on any increase or decrease of the PRODUCT Price in connection with any proposed changes, the PRO...
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. 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. 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. 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. 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. 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 []**
Change to Specifications. Sipex has the right to propose to modify, change or alter the Specifications from time-to-time, at its sole discretion and upon reasonable written notice to Silan. Such changes shall not be implemented by Silan unless Silan consents to such changes. Silan shall either accept or reject a proposed change within thirty (30) days of receiving notice of such proposed change. Silan's failure to respond to such proposed change within such period shall be deemed its approval of such change. If the Parties cannot reasonably agree on the proposed changes to the Specifications, Silan shall continue to manufacture Sipex Products in accordance with the existing Specifications. Silan shall not unreasonably withhold its consents to changes to the Specifications proposed by Sipex. In implementing agreed upon such changes, the Parties shall, through good faith negotiations, agree upon any changes to the delivery schedule of the Sipex Products subject to such Specification changes and Sipex's and Silan's respective responsibilities, in accordance with Section 8.3 for the costs incurred by Silan in connection with such changes.
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.
