Changes to the Specifications. (i) Additional Specifications for the API may be agreed upon by the parties until Media 100's final acceptance of the Supplier Product. Media 100 acknowledges that significant changes to the Specifications may result in a change in the delivery time table.
(ii) If any such modification of the Specifications by Media 100 does require Supplier's expenditure of significantly more time and effort, additional fees must be agreed upon in writing by the parties prior to implementation of modifications.
Changes to the Specifications. Any changes to the Specifications will be made in accordance with the Quality Agreement.
Changes to the Specifications. If Client desires to change the Specifications, Client shall notify OpenSite. All such changes to the Specifications shall be made by OpenSite pursuant to the terms and conditions of a separate Consulting Services Agreement and not pursuant to the terms and conditions of this Agreement. Client hereby acknowledges and agrees that such changes to the Specifications may result in one or more of the following: (i) changes to the Schedule; (ii) delays in the development of the Auction Site; or (iii) custom development work.
Changes to the Specifications. 4.1 The Buyer may request a change to the Specifications by submitting a request to SBT.
4.2 SBT will review the request and, if approved, will inform the Buyer of any changes to the Purchase Price, Delivery Date and/or Specifications of the Goods.
Changes to the Specifications. Each Party shall be available to consult, and shall cooperate with the other Party with respect to any changes to the Specifications NeurogesX requires to facilitate obtaining Marketing Approval for the Patches in the Territory. Without limiting the foregoing, neither Party shall unreasonably withhold its approval for any changes to the Specifications that (a) NeurogesX reasonably determines are necessary for its efforts to obtain such Marketing Approval for the Patches in the Territory or (b) LTS reasonably determines are necessary to meet the CMC section of any HMD or NDA for the Patch (or the equivalents thereof outside the United States). The Party requesting such change shall be fully responsible for any reasonable delay, complications and/or cost increases connected to such change. Changes to the Specification which are mutually agreed upon in writing shall apply to all Patches and/or Clinical Samples ordered after the date of such change, unless otherwise agreed upon by the Parties.
Changes to the Specifications. NeurogesX shall have the sole right to modify the Specifications with respect to all Bulk Products and Finished Products. All modifications shall be in writing and shall be signed by an authorized representative of NeurogesX and CPL, and shall be effective for purchase orders for Product placed after the effective date of the changes. If the modifications result in a change in CPL’s manufacturing costs, the Parties shall agree upon an appropriate adjustment to the price of the Product under this Agreement. If the modifications result in a delay in delivery, there shall be a reasonable extension of the affected lead times. If residual inventory of a raw material or packaging component results from a change to Specifications, NeurogesX shall reimburse CPL at cost plus 15% (to cover CPL’s administrative, finance, and warehousing) for all residual inventory or restocking charges at suppliers, for materials that CPL cannot use elsewhere or returned without charge.
Changes to the Specifications. As between the parties, Transcept shall have the sole right to modify the Product Specifications. All modifications shall be in writing and shall be signed by an authorized representative of Transcept and Mikart, and shall be effective for Purchase Orders for Product placed after the effective date of the changes. If the modifications result in a material change in Mikart’s manufacturing costs, the parties shall agree upon an appropriate adjustment to the price of the Product under this Agreement. If the modifications result in a delay in delivery, the parties will negotiate a reasonable extension of the affected lead times, provided that Mikart shall use diligent efforts to mitigate such delay. Notwithstanding anything to the contrary set forth in this Section 2.5, changes to material and component Specifications and/or procedures that are required to comply with official or compendial revisions or directives of any Regulatory Agency will be made and implemented by Mikart on or before the published or stated effective date for such changes, and will require neither advance notice to nor approval by Transcept; provided, however, that Mikart will notify Transcept in writing of any changes related to the Active Materials (as defined in Section 2.11 hereof), and Mikart will include all changes described in this Section 2.5 in the documentation provided to Transcept for inclusion in the annual report for the Product. Should such changes require advance notice to or approval by any Regulatory Agency, Mikart shall also notify Transcept promptly in writing after identification of such changes, and Mikart will provide support to Transcept in order to effect such changes by the published or stated effective date therefor.
Changes to the Specifications. As provided in Section 5(a) (Compound Changes) of the Agreement. * * * * * BEN VENUE REQUIREMENTS For Customers Supplying Material PRIOR TO SHIPPING MATERIAL TO BVL, THE CUSTOMER IS REQUIRED TO:
1. Contact BVL Materials Management to obtain a PO number to aid in proper receipt of your materials at each of our warehouse locations (See proper address’s below)
2. Each shipment must contain a packing slip that includes: In addition to the packing slip, the following should be included with the shipment: BVL Materials Management contacts;
Changes to the Specifications. As provided in Section 5(a) (Compound Changes) of the Agreement.
Changes to the Specifications or to the Manufacturing Process. Kureha shall obtain the prior written consent of Ocera, which shall not be unreasonably withheld, with respect to any proposed revision to the Specifications, and any change in the Raw Materials, equipment, process or procedures used to manufacture the Compound (the “Manufacturing Process”) that would require pre-approval of the FDA or other applicable regulatory authority of any country of the Licensed Territory in which the Compound is then being sold or developed (the “Pre-Approved Changes”). Except as may be required by Section 6.7(b), Kureha is not required to disclose any confidential information related to the Manufacturing Process to Ocera. Kureha is not required to obtain the consent of Ocera for any revisions to the Specifications or the Manufacturing Process that would not require pre-approval of the FDA or other applicable regulatory authority of any country of the Licensed Territory (“Other Changes”), provided that Kureha shall notify Ocera of such Other Changes and shall provide all information required by the FDA or equivalent foreign regulatory agency. Any changes to the Specifications or to the Manufacturing Process shall be in compliance with the NDA for the Compound. The corresponding costs of implementing any changes to the Specifications or to the Manufacturing Process will be borne by Kureha.
