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.
Changes to the Specifications. Any changes to the Specifications will be made in accordance with the Quality Agreement.
Changes to the Specifications. 4.1 The Buyer may request a change to the Specifications by submitting a request to SBT.
Changes to the Specifications. If the Client desires to change the Specifications, the Client shall immediately 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. The 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. As provided in Section 5(a) (Compound Changes) of the Agreement. * * * * * SUPPLY AGREEMENT *** Confidential Treatment Requested EXHIBIT C Pharmion Receiving Requirements * * * * * BEN VENUE REQUIREMENTS For Customers Supplying Material 11/02N 4/03R 10/03R PRIOR TO SHIPPING MATERIAL TO BVL, THE CUSTOMER IS REQUIRED TO:
Changes to the Specifications. As provided in Section 5(a) (Compound Changes) of the Agreement. * * * * * SUPPLY AGREEMENT *** Confidential Treatment Requested
Changes to the Specifications. As between the Parties, Purchaser shall have the sole right to modify the Specifications with respect to the Product. All modifications shall be provided to Supplier in writing at least [***] prior to the effective date of such changes, shall be signed by an authorized representative of Purchaser and Supplier, 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 Supplier’s manufacturing costs, the Parties shall negotiate in good faith to agree upon an appropriate adjustment to the price of the Product under this Agreement commensurate with the change in Supplier’s manufacturing costs. If the modifications result in a delay in delivery, the Parties will negotiate a reasonable extension of the affected lead times.
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 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.
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.
