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.
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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). [**]

Related to Sarepta Requested Changes

  • DATA REQUESTS Upon the written request of the District, the State Auditor’s Office, the Appraisal District, or the Comptroller during the term of this Agreement, the Applicant, the District or any other entity on behalf of the District shall provide the requesting party with all information reasonably necessary for the requesting party to determine whether the Applicant is in compliance with its rights, obligations or responsibilities, including, but not limited to, any employment obligations which may arise under this Agreement.

  • Employee-Requested Schedule Changes Overtime-eligible employees’ workweeks and work schedules may be changed at the employee’s request and with the Employer’s approval, provided the Employer’s business and customer service needs are met and no overtime expense is incurred.

  • Requested                           Attachments Pricing Form 1 (Part 1) 230104 Pricing Form 1 (Part 1).xlsx Pricing Form 2 (Part 1) 230104 Pricing Form 2 (Part 1).xlsx

  • Minor Administrative Changes System Agency is authorized to provide written approval of mutually agreed upon Minor Administrative Changes to the Project or the Contract that do not increase the fees or term. Upon approval of a Minor Administrative Change, HHSC and Grantee will maintain written notice that the change has been accepted in their Contract files.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Interim Changes Since the date of its balance sheets, except as set forth in Exhibit C, there have been no (1) changes in financial condition, assets, liabilities or business of Amalgamated which, in the aggregate, have been materially adverse; (2) damages, destruction or losses of or to property of Amalgamated, payments of any dividend or other distribution in respect of any class of stock of Amalgamated, or any direct or indirect redemption, purchase or other acquisition of any class of any such stock; or (3) increases paid or agreed to in the compensation, retirement benefits or other commitments to its employees.

  • Program Changes Contractor agrees to inform the County of any alteration in program or service delivery at least thirty (30) days prior to the implementation of the change, or as soon as reasonably feasible.

  • Execution of Change Orders Change Orders shall be signed by the Contractor, ordinarily certified by the Design Professional, and approved by the Owner in accordance with the form of Change Order prescribed by the Owner. No request for payment by the Contractor for a Change Order shall be due, nor shall any such request appear on an Application for Payment, until the Change Order is executed by the Owner. In the event of emergency (see Article

  • CONTRACTOR NAME CHANGE An amendment is required to change the Contractor's name as listed on this Agreement. Upon receipt of legal documentation of the name change the State will process the amendment. Payment of invoices presented with a new name cannot be paid prior to approval of said amendment.

  • 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.

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