Draxis Changes Clause Samples

Draxis Changes. With the exception of compendial changes (i.e., USP/EP/BP). Draxis shall not make any revisions to the Specifications without prior written consent of GSK in accordance with the Change Control Operating Procedure. GSK retains the right and responsibility for final approval of the Specifications for Products. All requests by Draxis for such revisions shall be submitted in writing to GSK on the forms included in the Change Control Operating Procedure. Draxis shall notify GSK, in writing and in reasonable detail, of (i) Draxis’ suggested change; (ii) the reasons for the suggested change; (iii) the perceived benefits of the suggested change to Draxis and GSK, respectively; and (iv) the estimated costs and timing of implementing such change. If the Parties implement a change in the Specifications hereunder, they shall negotiate any changes in any affected Purchase Order to provide reasonable accommodation for changed circumstances. Draxis shall be responsible for documenting all revisions to the Specifications, subject to GSK’s approval, in accordance with the Change Control Operating Procedure, as applicable.