Sarepta Requested Changes Sample Clauses

Sarepta Requested Changes. Sarepta shall have the right to request reasonable modifications to the Scope of Work by providing notice thereof to Catalent. Upon receipt of such notice, Catalent shall generate a Change Order in accordance with the process described in Section 4.8(a) and submit such Change Order to the Sarepta authorized representative for review and approval. If the Sarepta authorized Representative approves the Change Order notwithstanding Catalent’s notice of any resulting cost increase, Sarepta shall reimburse Catalent for the cost of such changes as detailed in the Change Order. Upon approval of such Change Order by the authorized Representative of each Party, the Change Order will be implemented [**] in a good faith effort to meet the development and manufacturing timelines as set forth in the Scope of Work or as described in the Change Order.
Sample 1
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Sarepta Requested Changes. Sarepta shall be entitled to change Manufacturing parameters and release for Bulk Drug Substance or Drug Product from time to time in its discretion, or to change any Specifications at the request, or as required, by any Governmental Authority and, provided that the Sarepta Requested Change(s) does not [**], Catalent shall make all revisions to the Specifications requested by Sarepta as described in the Quality Agreement and develop, support and submit any Catalent Facility-related regulatory submissions in a timely fashion to support Sarepta’s effecting that change. Sarepta retains the right and responsibility for final approval of Specifications for Bulk Drug Substance and Drug Product. Sarepta shall pay Catalent the documented amounts incurred in implementing a change to the Specifications requested by Sarepta under this Section 5.12(b). [**]
Sample 1

Related to Sarepta Requested Changes

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

  • Product Changes IDSI reserves the right to make design and other modifications in the Equipment at any time but shall not be obligated to implement such modifications in Equipment that has previously been delivered.

  • Interim Changes Except as set forth on Schedule 3.29, since December 31, 2006, there has been no:

  • Notification of Changes Subscriber agrees and covenants to notify the Company immediately upon the occurrence of any event prior to the consummation of this Offering that would cause any representation, warranty, covenant or other statement contained in this Agreement to be false or incorrect or of any change in any statement made herein occurring prior to the consummation of this Offering.

  • Notice of Changes At any time during the term of this Agreement, as supplemented from time to time, the Company shall advise the Agent immediately after it shall have received notice or obtain knowledge thereof, of any information or fact that would alter or affect any opinion, certificate, letter and other document provided to the Agent pursuant to this Section 3.

  • Business Changes Change in any material respect the nature of the business of the Borrower or its Subsidiaries as conducted on the Effective Date.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Ownership Changes Without regard to this Agreement, neither the Company nor any of its Subsidiaries has undergone an “ownership change” within the meaning of Section 382 of the Code.

  • Term SOFR Conforming Changes In connection with the use or administration of Term SOFR, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document. The Administrative Agent will promptly notify the Borrower and the Lenders of the effectiveness of any Conforming Changes in connection with the use or administration of Term SOFR.

  • Approval Process Tenant shall notify Landlord whether it approves of the submitted working drawings within three business days after Landlord’s submission thereof. If Tenant disapproves of such working drawings, then Tenant shall notify Landlord thereof specifying in reasonable detail the reasons for such disapproval, in which case Landlord shall, within five business days after such notice, revise such working drawings in accordance with Tenant’s objections and submit the revised working drawings to Tenant for its review and approval. Tenant shall notify Landlord in writing whether it approves of the resubmitted working drawings within one business day after its receipt thereof. This process shall be repeated until the working drawings have been finally approved by Landlord and Tenant. If Tenant fails to notify Landlord that it disapproves of the initial working drawings within three business days (or, in the case of resubmitted working drawings, within one business day) after the submission thereof, then Tenant shall be deemed to have approved the working drawings in question. Any delay caused by Tenant’s unreasonable withholding of its consent or delay in giving its written approval as to such working drawings shall constitute a Tenant Delay Day (defined below). If the working drawings are not fully approved (or deemed approved) by both Landlord and Tenant by the 15th business day after the delivery of the initial draft thereof to Tenant, then each day after such time period that such working drawings are not fully approved (or deemed approved) by both Landlord and Tenant shall constitute a Tenant Delay Day.

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