Required Changes. (a) The LFC may propose a Required Change by notice to the Service Provider, being a change to:
Required Changes. For changes to the Product Specifications or Manufacturing relating solely to the Products that are required by Laws and other Regulatory Requirements (including, without limitation, cGMP), or by medical or scientific concerns as to the toxicity, safety and/or efficacy of the Products (collectively, “Required Changes”), the Parties shall cooperate in making such changes promptly.
Required Changes. Licensee may amend previously Approved Plans if required to obtain or comply with other Regulatory Approvals necessary for installation of Equipment, including construction or installation-related temporary street occupancy permits, traffic control permits, and building permits, as may be required by City codes. Amendment of Approved Plans will require the City’s approval. Licensee acknowledges that as of the Effective Date of this Master License, the City has not approved or promised to approve any plans, specifications, or permits necessary for Licensee to install Equipment on any City Poles. The City will provide notice of its decision in accordance with Section 28.1 (Notices).
Required Changes. Should the Federal, State or local government require any changes in construction regarding insulation standards other than those standards in effect at the time of the execution of this Contract, Purchaser agrees to pay for any additional cost in connection therewith. As per FTC Trade Regulation Rule, Seller has provided to Purchaser the insulation standards that will be used in the construction of the Residence and the Purchaser hereby expressly acknowledges receipt of same.
Required Changes. If Customer’s site rules or any engineering standards, codes of practice, laws, or decisions or guidance issued by courts or public authorities are enacted or amended after the effective date of the Order, Siemens will be entitled to an adjustment of the Order, including an adjustment of the fees to reflect any additional costs to be incurred by Siemens, the time schedules, and scope of Offerings, as necessary to compensate for any adverse effects or additional requirements deriving from such changes.
Required Changes. With respect to any changes to the Specifications or to any process involved in the manufacture, Packaging, Labeling, storage, transportation, delivery or testing of the Product that are required by Applicable Laws or by mandate of an applicable government authority (including the FDA), the parties shall reasonably cooperate in making such changes promptly, and Seller shall, subject to Section 4.1 and unless otherwise mutually agreed to in writing by the parties, bear the costs of implementing such changes, including the cost of scrapping materials (including raw materials, in-process materials, inventory and packaging material) associated with such changes.
Required Changes. If the FDA or any other Regulatory Authority requests or requires, or takes any action that requires, any change in the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the source of Materials or Methods of Analysis with respect to the Product, the Parties shall meet and discuss an implementation plan for such change and use commercially reasonable efforts to accommodate as soon as practicable such change to meet the FDA’s or such other Regulatory Authority’s requirements. ULURU will bear its respective costs associated with, or incurred as a result of, such change. Each Party agrees to promptly forward to the other copies of any written communication received by such Party from the FDA or any other Regulatory Authority that may affect the Manufacture, supply, or distribution of the Product as contemplated herein.
Required Changes. If, at any time, a Manufacturing Change is required by a Governmental Authority in a country in which Regulatory Approval for a given Product has been granted, a Governmental Authority in a country in which Customer seeks to obtain Regulatory Approval for a given Product, or a Governmental Authority in the country in which the Facility that manufactures a given Product is located, then the Party that first has knowledge of the required Manufacturing Change shall notify the other Party in writing of such required Manufacturing Change, and Manufacturer will review such Manufacturing Change with Customer. Manufacturer will bear all costs and expenses associated with implementing the Manufacturing Change, unless such Manufacturing Change relates solely to a Product or Products manufactured for Customer (including any required labeling changes), in which case Customer will bear all costs and expenses associated with implementing such Manufacturing Change for such Product, including any changes to labeling or packaging, but only to the extent such costs are reasonable and documented.
Required Changes. Subject to the Customer’s written permission, not be unreasonably withheld or delayed, the Company reserves the right to make any reasonable changes in the specification of the Services as required to comply with any applicable health and safety or statutory requirements or which do not materially affect the nature, quality or performance of the Services.
Required Changes. ActaMed shall be required to develop and implement, at its expense except to the extent hereinafter provided, as promptly as practicable and in no event later than thirty (30) days prior to the effective date of the applicable Regulatory Change, any Changes which (i) ActaMed determines are required for the Network Software to remain in compliance with all applicable Regulations, or (ii) SBCL requests in writing to ActaMed for compliance with Regulations of the Network Software.
