Change to Specifications Clause Samples

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. 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. 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. 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. 6.1 MSK may notify the Supplier in writing of any change in the desired specification (including as to the quality and time frame). 6.2 If the change would reduce the Supplier’s costs, the contract price will reduce to fairly reflect that saving. 6.3 If the change would increase the Supplier’s costs, the Supplier will notify MSK within two (2) working days, in writing, whether it proposes a revision of the Contract price and of the amount of this revision. 6.4 The Supplier and MSK will then use their reasonable efforts to agree the revised terms in full, including as to price, pending which the contract variation will not take effect. 6.5 If the change would for any reason be unachievable, the Supplier will notify MSK within one (1) working day in writing with reasons. 6.6 Both parties will use reasonable efforts to reach a mutually acceptable contract variation. If such mutually acceptable variation cannot be agreed, MSK may revert to the original specification or cancel the Purchase Order, in which case it will reimburse the Supplier for any direct costs reasonably incurred by the Supplier prior to cancellation, which costs the Supplier will take all reasonable steps to minimise.

Change to Specifications. No changes can be made without Seller’s approval once the Buyer’s order has been accepted.

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.