Changes Required by Applicable Law. VIVUS will promptly, at its own expense, implement any changes to any procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product required by Applicable Law or the NDA (collectively, “Required Manufacturing Changes”); provided that Purchaser shall be responsible for any and all expenses arising from any such changes required by any changes to the NDA submitted to any Regulatory Authority by the Purchaser without VIVUS’ prior written consent.
Changes Required by Applicable Law. Notwithstanding Section 3.5(a), XXXX shall not unreasonably refuse any written request from CLIENT to make changes to the Process, Product Specifications or Project Plan that are required by changes in an applicable Regulatory Authority or Applicable Laws, provided that it is feasible for XXXX to effect such improvement without requiring any capital investment or major process changes on the part of XXXX. Notwithstanding the provisions of this Section 3.5(b), no change to Services, Process, Product Specifications or any Project Plan shall be made except by a Change Order signed by the authorized representatives of the Parties. CLIENT agrees to pay XXXX any commercially reasonable increase in cost for Services, materials or equipment associated with a change in Services under this Section 3.5(b).
Changes Required by Applicable Law. If Supplier is required to change the Specifications in order to comply with Applicable Law, Supplier will promptly notify Zogenix of such changes and the cost of such changes. If Zogenix is unable to accept or unwilling to have such changes made, Zogenix will have the option of terminating this Agreement immediately upon notice to Supplier.
Changes Required by Applicable Law. If Supplier is required to change any Raw Material, Manufacturing Process or the Specification for a Product in order to comply with Applicable Law, Supplier will promptly notify Company of such change and the cost of such change. The costs of any such change shall be equitably allocated by Supplier amongst its then existing customer base.
Changes Required by Applicable Law. If changes to the Services are necessary in order to comply with applicable Laws, or changes to Service Provider’s third party contracts, Service Provider will make such changes unless such changes are not practicable given the Service Provider Systems. Any changes will be documented either in Supplements or by an amendment to this Agreement, or both; and in any case, shall reflect the Parties’ joint agreement on the applicable charges for any necessary changes to Services. If providing such changed Services is not practicable given the Service Provider Systems, Customer may purchase such services from a third party, provided that the Parties must agree on, and shall not unreasonably withhold their consent with respect to, (i) the activities required to transition the affected Services from Service Provider to such third party, (ii) the impact on the remaining Services, (iii) the charges associated with removing such Services, and (iv) the charges for the remaining Services as determined by the Price Adjustment Process in Schedule C.
Changes Required by Applicable Law. We may vary this Agreement (including changing or introducing new charges or changing or withdrawing Services) where required to comply with Applicable Law. We will notify you of such change as is reasonably practicable. ASSIGNMENT AND SUBCONTRACTING
Changes Required by Applicable Law. If Customized Services are necessary in order to comply with applicable Laws or changes to Supplier’s third party contracts, Supplier will provide such Customized Services unless (i) such Customized Services require a material change to a Supplier System, or the implementation of a new Supplier System, or (ii) providing such Customized Services is not practicable given the then-current characteristics of the Supplier Systems, and the use thereof for Supplier and its Affiliates, and subject to the Parties jointly agreeing on the applicable Charges for such Customized Services. Any such Customized Services will be provided under Supplements to Schedule A-1 or Schedule A-2, as applicable. The Parties will negotiate in good faith in order to promptly agree on the applicable charges for any such necessary Customized Services. If providing such Customized Services is not practicable given the Supplier Systems, Recipient may purchase such services from a third party, provided that the Parties must agree on (A) the activities required to transition the affected Services from Supplier to such third party, (B) the impact on the remaining Services, and (C) the Charges associated with removing such Services and (D) the Charges for the remaining Services.
Changes Required by Applicable Law. If Supplier is required to change the Specifications in order to comply with Applicable Law or Governmental Agency, Supplier will promptly notify Endo of such changes and the cost of such changes. If either Party is unable or unwilling to make such changes, Endo will have the option of terminating the Product PSS with *** notice to Supplier and Supplier will have the option of terminating this Agreement with *** notice to Endo
Changes Required by Applicable Law. If Fxxxxx is required to change the specifications in order to comply with the requirements of the FDA or any other Governmental Authority, Fxxxxx will promptly notify the Company of such changes and the cost of such changes shall be borne by Fxxxxx unless the mentioned variation, in the opinion of the JSC, entails a benefit to the Company, in which case the costs arising from the changes and its implementation shall be borne by the Company.
Changes Required by Applicable Law. If Customized Services are necessary in order to comply with applicable Laws or changes to any Contracts or Permits to which Seller or any Seller Affiliate is party, Seller shall promptly notify Buyer in writing of any impairment on Seller’s ability to provide any Services and provide such Customized Services unless (i) such Customized Services require a material change to a System or the implementation of a new System, or (ii) providing such Customized Services is not practicable for Seller given the then-current characteristics of the Systems. In such case that Seller is required to provide such Customized Services, Buyer and Seller shall negotiate in good faith to amend Exhibit A to revise the Service Fees applicable to such Customized Services; provided, that, Seller shall be obligated to provide the Customized Services during such negotiation period, subject to the Parties equitably reimbursing the applicable Party for any under- or over-payment of Services Fees during such negotiation period as compared to the amended Service Fees, if any, agreed to in such amendment to Exhibit A. If providing such Customized Services is not required under clause (i) or (ii) above, the applicable Acquired Entity or Buyer may purchase, at Buyer’s cost and expense, such services from a third party. Upon such an event, Buyer and Seller shall negotiate in good faith to agree upon (A) the activities required to transition the affected Services from Seller (or a Seller Affiliate or Subcontractor, as applicable) to such third party, (B) the impact on the remaining Services, (C) the decrease in Service Fees associated with removing such Services and (D) the Service Fees for the remaining Services; provided, that, upon termination of such Services, Buyer shall have no further obligation to pay the Service Fees for such Services.
