Specifications; Changes. In the event that RELYPSA wishes to change the Specifications, or in the event that RELYPSA is required to change the Specification pursuant to Laws or in response to the order or request of an Authority:
(i) RELYPSA shall promptly advise PATHEON in writing of any such change(s) to such Specifications, and PATHEON shall promptly advise RELYPSA as to any scheduling and/or Price adjustments which may result from any such change(s), if any. The notification and approval procedure shall be in accordance with Quality Agreement, as well as any additional standard operating procedures (i.e., change control procedures) agreed by RELYPSA and PATHEON in writing from time to time.
(ii) Prior to implementing change(s) to the Specifications, RELYPSA and PATHEON shall negotiate in good faith in an attempt to reach agreement on (i) the new Price, if any, for Bulk or Finished Product which embodies such change(s) to the Specifications, giving due consideration to the effect of such change(s) on PATHEON’s costs for Bulk and Finished Product as well as any other relevant factors, (ii) the costs, if any, to PATHEON of implementing such changes, and (iii) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the lead time for Firm Orders). Implementation of such change(s) to the Specifications shall be as set forth in the Quality Agreement.
(iii) RELYPSA will reimburse PATHEON for the reasonable and necessary expenses incurred by PATHEON as a result of any such change(s) to the Specifications, including, but not limited to, reimbursing PATHEON for [***].
(iv) Upon PATHEON’s receipt of a written notice from RELYPSA regarding any change in Specifications, PATHEON shall not commence or continue to manufacture and RELYPSA shall have no obligation to accept or pay for Bulk or Finished Product after receipt of such notice without RELYPSA’s prior written consent in its sole discretion, and RELYPSA shall only be required to accept Bulk and Finished Product that conforms to amended Specifications incorporating such change in Specifications. Any Bulk or Finished Product as to which manufacturing has commenced or is completed by PATHEON prior to receipt of such written request for a change in Specifications and which is Released by PATHEON and otherwise conforms to this Agreement under the prior Specifications shall be paid for by RELYPSA.
Specifications; Changes. (a) Supplier will manufacture Product in accordance with the Specifications.
(b) Supplier will notify Google in writing ninety (90) days in advance of implementing any change to a Product, including, without limitation, any change to the: form, fit, function, design, appearance, location of manufacture, components, component vendor, or manufacturing process of any Product.
(c) Any change to the form, fit, or function of a Product that makes the Product no longer meet its Specification will be deemed a discontinuation of that Product and Supplier will give Google notice of such discontinuation pursuant to Section 4.9 above.
Specifications; Changes. (a) The Commercial Products shall conform to the Product Specifications, including labeling and packaging requirements, as set forth in Attachment A attached hereto, as may be revised and further defined by written agreement of the Parties in the course of the Development Work or thereafter. During the Supply Period, proposed changes to the Product Specifications must be communicated at least ninety (90) days in advance of the proposed effective date of such changes unless specific circumstances make a more timely action necessary; provided that the Product Specifications may be modified only with the written approval of duly authorized representatives of both SurgiQuest and WOM, who initially shall be:
(i) For SurgiQuest: Xxxxxx Xxxxxxx, Senior Director of Operations
(ii) For WOM: Xxxxxx Xxxxxx
(b) At the request of SurgiQuest, WOM agrees to use Commercially Reasonable efforts to make changes to the Commercial Products to the extent possible and as soon as practicable after receiving a written change request from SurgiQuest, provided SurgiQuest agrees to reimburse WOM for all reasonable costs and expenses incurred by WOM in making the requested change, including the cost of parts and components made obsolete by the change, which costs and expenses shall be approved in writing by SurgiQuest prior to any work in connection with such change.
Specifications; Changes. Buyer may at any time propose a change in the Specifications by submitting written notice to Seller detailing the nature, extent and proposed manner of performance of the proposed change, and estimated scheduling, pricing and cost information relating thereto. Seller shall evaluate each such request, and submit to Buyer a written response to each such request within thirty (30) business days following receipt thereof, unless otherwise agreed by the Parties. Seller’s written response shall address any impact the proposed changes will have on the Initial Purchase Order or any pending Additional Purchase Orders and on manufacture of the Products. The Parties shall negotiate the desired changes in good faith. If the Parties mutually agree to the changes, Buyer shall prepare a written description of the agreed changes (a “Specifications Change”), which will become effective when it is signed by both Parties. The Specifications Change will be incorporated into this Agreement and as part of any relevant Initial Purchase Order or pending Additional Purchase Orders and will prevail over any inconsistent terms of thereof. Seller shall implement such mutually agreed changes in an expeditious and commercially prudent manner.
Specifications; Changes. The Boat will materially conform to the specifications expressly set forth in the attached SPECIFICATIONS (Exhibit A.). All changes to the Specifications must be in a writing signed by Seller and Buyer (a “Change Order”). Buyer acknowledges and agrees that any Change Order may result in an increase of the Purchase Price, and that any such increase will be set forth expressly in such Change Order.
Specifications; Changes. Either Party may request a Specifications change intended to maintain high standards or compliance with Laws or to bring the Specifications into compliance with high standards or Laws.
(a) XenoPort Requested Changes. XenoPort will be entitled to change the Specifications for a Product from time to time, and Patheon will make all revisions to the Specifications requested by XenoPort, in accordance with the Change Control Operating Procedures as per Section 4.4 below. XenoPort retains the right and responsibility for final approval of the Specifications for the Products. For all changes to the Specifications requested by XenoPort pursuant to this Section 4.3(a), XenoPort will, in its discretion, either (i) perform, or arrange for the performance of, all development work in connection therewith or (ii) have Patheon perform the development work at the Facility upon written acceptance by XenoPort of Patheon’s estimated costs and timelines.
