Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.
Changes to Specifications. All Specifications and any changes thereto agreed to by the Parties from time to time shall be in writing, dated and signed by the Parties. No change in the Specifications shall be implemented by Cardinal Health, whether requested by Reliant or requested or required by any Regulatory Authority, until the Parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change. Cardinal Health shall respond promptly to any request made by Reliant for a change in the Specifications, and both Parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. If after initial Product qualification, Reliant requests a change in the Specifications for its own benefit or to comply with the requirements of a Regulatory Authority, the Specifications shall be amended as soon as [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. possible after a request is made for any change in Specifications, and Cardinal Health shall notify Reliant of the costs associated with such change and shall provide such supporting documentation as Reliant may reasonably require. Reliant shall pay all costs associated with such Reliant-requested changes or changes required by a Regulatory Authority as may be agreed upon by the Parties. Changes, agreed to between the Parties, for the benefit of Cardinal Health, shall be at the expense of Cardinal Health. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control.
Changes to Specifications. If the Purchaser wishes to change the Specifications, the Purchaser must notify the Supplier of its requested changes. The parties must promptly discuss whether, and any terms and conditions on which, the Supplier is willing (acting reasonably) to agree to the Purchaser’s requested changes to the Specifications. Any changes to the Specifications, and any terms and conditions applying to such changes:
7.2.1 must be mutually agreed by the parties in writing; and
7.2.2 take effect 3 months after they are agreed; unless the changes are business critical, in which case, they take effect as soon as practicable after they are agreed and no later than 3 months after they are agreed.
Changes to Specifications. All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change. Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control.
Changes to Specifications. Any change to Specifications shall require each Party’s mutual agreement, to be negotiated in good faith between the Parties. The Parties will report any change as required by the FDA and/or any applicable Governmental Authority. Aratana shall have at least [***] months from date of the Parties’ agreement to implement such changes to the Specifications. If any such change will result in an increase or decrease in the manufacturing costs, timing, or requirements of the API, the Parties shall negotiate in good faith and agree upon corresponding adjustments this Agreement.
Changes to Specifications. GM and Supplier shall discuss on an annual basis any proposed changes to the Specifications for the following year, in all cases upon at least twelve (12) months' prior written notice. Any changes to the Specifications and timing of implementation of such changes shall be as agreed in writing by the Parties. Any additional processing costs arising from changes to the Specifications requested by GM shall be paid by GM or the Designated Purchaser.
Changes to Specifications. If, subsequent to the Effective Date of this Agreement: 1) the manufacturer of the Apparatus (or a manufacturer of a component therein) makes design and/or production changes, including, but not limited to future drivetrain upgrades (such as engine, transmission or axle upgrades) (“Manufacturer Modifications”); or 2) design or production changes are made to the Apparatus to comply with any applicable government regulation (such as the Federal Motor Vehicle Safety Standards or the Environmental Protection Agency Emissions Standards) or industry standards (such as those adopted by the National Fire Protection Association) (cumulatively referred to hereinafter as “Compliance Modifications”), and if there is an increase in costs to Atlantic as a result of Manufacturer Modifications or Compliance Modifications, the Purchase Price shall be automatically adjusted to reimburse Atlantic for said costs. Atlantic shall make reasonable efforts to advise the Customer of such changes within a reasonable time and provide documentation to support any changes in price to Customer upon request. In addition, Customer and Atlantic may agree to make changes to the Specifications, but any such changes must be by written change order signed by Customer and Atlantic (“Change Order”). However, in the case of Manufacturer Modifications or Compliance Modifications resulting in additional costs to Atlantic, Atlantic may execute Changes Orders without joinder of Customer, and any such Change Orders shall be binding on Customer. Atlantic shall not be liable to Customer for any delay in performance or delivery arising from any Change Order.
Changes to Specifications. (a) Material changes to requirements contained in the Scope of Work that occur during the term of the Scope of Work shall be estimated separately. Any new requirements to specifications and changes to the costs thereof contained in the Scope of Work shall require the signatures of the authorized representative of the parties hereto prior to commencement of services relating thereto.
(b) A separate estimate and approval process shall not be required when SOFTSERVE reasonably determines that new functionality simply replaces previously defined functionality (not yet implemented) and the changes will not adversely impact delivery schedules and/or change costs to be payable by CLIENT for such Services.
(c) Either party may request changes to a Scope of Work by preparing and submitting a written proposal (“Change Authorization”), which sets forth any modifications needed to complete the applicable Scope of Work, including changes to the specifications, charges, assumptions, scope, scheduling or other terms. An executed Change Authorization or other written agreement approved and signed by both parties is the only means of modifying a Scope of Work. When both parties sign the Change Authorization, the change will become a part of the Scope of Work as of the date of the last signature. The most recent Change Authorization will modify and take precedence over any inconsistent terms of either the Scope of Work or any previous Change Authorizations. Neither party is obligated to execute a Change Authorization but both parties agree to use reasonable commercial efforts to address and resolve any requests for Change Authorizations.
(d) In particular, if CLIENT seeks to make a Change Authorization to (i) amend, modify or change the Services and/or Deliverables specified in a Scope of Work or (ii) change the way such Services are billed pursuant to a Scope of Work (i.e. Time and Material, or Fixed Price basis), CLIENT will pursue a Change Authorization subject to compliance with the following procedures:
(i) Submission of Request. CLIENT will submit all Change Authorization Requests in writing to SOFTSERVE (hereinafter “Change Request”).
(ii) SOFTSERVE Response. SOFTSERVE will evaluate each Change Request as soon as possible, but not later than five (5) business days following SOFTSERVE’s receipt of the Change Request. If SOFTSERVE determines in its best business judgment that it cannot accept the Change Request, SOFTSERVE will provide a written response to CLIENT withi...
Changes to Specifications. Orion will not modify any of the Specifications, specifications for any of the raw materials used in producing the Product (including without limitation the Compound), or any process or procedure used to manufacture the same, or change the equipment used in the manufacture of Product (except for repair or replacement of existing equipment), or change any of its suppliers of any raw materials used in producing Product, in each case without obtaining the prior written consent of USL, such consent not to be unreasonably withheld, and any approvals required for purposes of obtaining or maintaining any Regulatory Approval of the Product affected by such modification. Any such change shall be implemented only after all necessary consents and approvals of, and notifications to, the FDA have been obtained or made, and shall be implemented in a manner that does not impact Orion’s ability to supply Product to USL in accordance with the provisions of Section 6. Orion shall be solely responsible for all costs and expenses incurred in making any such changes or modifications, except to the extent such changes or modifications have been requested by USL, in which case such costs shall be borne by USL; provided further that should such changes result in economic benefit for Orion the allocation of such costs and expenses between the Parties shall be separately agreed, as reasonable. The Parties acknowledge that the Specifications for Product attached hereto as Schedule 4 are preliminary and the Parties shall work in good faith to finalize such Specifications at the appropriate time; provided, however, for clarity, such final Specifications shall be subject to FDA approval.
Changes to Specifications. (a) If Connetics desires any material change to the Specifications or manufacturing process, Connetics shall deliver, sixty (60) days prior to the expected date of implementation, written notice to APG specifying such change desired by Connetics, and APG shall acknowledge in writing any such notice within thirty (30) days after APG receives the notice; provided, however, that the Specifications or process shall not be supplemented, modified or amended in any respect without the prior written agreement of the Parties. APG will use Commercially Reasonable Efforts to implement changes within one hundred and twenty (120) days after APG's acknowledgement of such notice. If Connetics requests a change to a Product Specification, including the manufacturing process, and APG agrees that such change is feasible, such change shall be incorporated within the Product Specification pursuant to a written amendment to this Agreement. Connetics shall be responsible for obtaining any required FDA approval prior to implementation of such a change at Connetics' cost.
(b) APG will communicate to Connetics in a timely manner any change in the Product Specification, including the manufacturing process, initiated by APG, and will obtain Connetics' written approval by way of written amendment of this Agreement incorporating such change within the Product Specification prior to implementation of the change. No such change may be instituted except in compliance with this Agreement and the Quality Agreement. Connetics shall have the option of obtaining, or having APG obtain any required FDA approval or other regulatory approval prior to implementation of such a change. APG may provide additional services in conjunction with the manufacture of Products, such as additional formulation, process development or stability testing, at the request of Connetics and pursuant to Connetics' purchase order, and all data and results from such additional services shall be owned by Connetics and protected as confidential under this Agreement.
