Changes or Modifications in Scope of Work Sample Clauses

Changes or Modifications in Scope of Work. (a) Sponsor will have the right from time to time to review or request changes to the Scope of Work pertaining to a particular Clinical Trial and/or Protocol, including but not limited to changes related to: • The Protocol • Case Report Forms (CRFs) • Safety reporting • Monitoring guidelines • Quality assurance guidelines • Data validation guidelines • Final study report format Any material alteration, modification or amendment to the Clinical Trial requested by Sponsor or TKL shall be made in a written notice to the other party as a “Change Order” to the Scope of Work. Each Change Order shall explain in detail the specific changes to the Clinical Trial, Protocol, Services, task, responsibility, duty, and/or timeline, as requested by Sponsor. Any Change Order submitted by Sponsor shall be approved in writing by TKL within 30 days. Sponsor shall have the right to approve or reject, within 30 days, a Change Order submitted to Sponsor by TKL. Sponsor reserves the right to remove services from the Services by notifying TKL, in writing, prior to TKL’s initiation of such services, subject to Sponsor’s payment obligations performed by TKL up to the date of notice and any other payment obligations as contemplated by Section 3 generally. In no event will Sponsor be obligated to pay for such removed services. An alteration, modification or amendment to a Clinical Trial shall be deemed to be “material” 1) by mutual agreement between Sponsor and TKL; or, 2) if such alteration, modification or amendment would, either individually or in the aggregate (taking into account any prior alterations, modifications or amendments in connection with such Clinical Trial not previously included in a Change Order), result in a greater than ten thousand dollar ($10,000.00) increase in a line item to the Budget Summary, attached hereto as Exhibit B. Changes in the Budget Agreement in amounts up to but not exceeding ten thousand dollars ($10,000.00) can occur with prior written approval by the Sponsor (e.g., approval by electronic mail) but without the requirement for amendment to the Scope of Work, provided that specific details for Internal Costs (as set forth in Exhibit B) and documentation for Pass Through Expenses are presented to the SPONSOR prior to TKL’s commencement of such services and TKL provides to Sponsor with itemized invoices for such expenses. Specific details for changes to Internal Costs include TKL’s timesheet system which may be audited at the Sponsor’s discretion ...
Sample 1
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Related to Changes or Modifications in Scope of Work

  • Amendments, Changes and Modifications This Agreement may be amended, changed, modified, altered or terminated only by written instrument or written instruments signed by all of the parties hereto.

  • Material Changes or Material Transactions Since the respective dates as of which information is given in the Registration Statement and the Prospectus, except as may otherwise be stated therein or contemplated thereby, there has been no material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business.

  • No Material Changes, Etc Since the Balance Sheet Date, there has occurred no material adverse change in the financial condition or assets or business of the Borrower as shown on or reflected in the balance sheet of the Borrower as of the Balance Sheet Date, or the statement of income for the fiscal year then ended, other than changes in the ordinary course of business that have not had any Material Adverse Effect either individually or in the aggregate.

  • Changes and Modifications (i) DST shall have the right, at any time, to modify any systems, programs, procedures or facilities used in performing its obligations hereunder; provided that the Fund will be notified as promptly as possible prior to implementation of such modifications and that no such modification or deletion shall materially adversely change or affect the operations and procedures of the Fund in using the TA2000 System hereunder, the Services or the quality thereof, or the reports to be generated by such system and facilities hereunder, unless the Fund is given thirty (30) days’ prior notice to allow the Fund to change its procedures and DST provides the Fund with revised operating procedures and controls.

  • Changes, etc This instrument and the provisions hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party against which enforcement of the change, waiver, discharge or termination is sought.

  • Material Changes; Undisclosed Events, Liabilities or Developments Since the date of the latest audited financial statements included within the SEC Reports, except as set forth on Schedule 3.1(i), (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. Except for the issuance of the Securities contemplated by this Agreement or as set forth on Schedule 3.1(i), no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is made.

  • Waiver or Modification Any waiver, modification, or amendment of any provision of this Agreement shall be effective only if in writing in a document that specifically refers to this Agreement and such document is signed by the parties hereto.

  • Software Modifications Company may request that BNYM, at Company’s expense, develop modifications to the software constituting a part of the Licensed System that BNYM generally makes available to customers for modification (“Software”) that are required to adapt the Software for Company’s unique business requirements. Such requests, containing the material features and functionalities of all such modifications in reasonable detail, will be submitted by Company in writing to BNYM in accordance with the applicable, commercially reasonable procedures maintained by BNYM at the time of the request. Company shall be solely responsible for preparing, reviewing and verifying the accuracy and completeness of the business specifications and requirements relied upon by BNYM to estimate, design and develop such modifications to the Software. BNYM shall have no obligation to develop modifications to the Licensed System requested by Company, but may in its discretion agree to develop requested modifications which it, in its sole discretion, reasonably determines it can accomplish with existing resources or with readily obtainable resources without disruption of normal business operations provided Company agrees at such time in writing to pay all costs and expenses, including out-of-pocket expenses, associated with the customized modification. BNYM shall be obligated to develop modifications under this Section 2.16 only upon the execution of and in accordance with a writing containing, to BNYM’s reasonable satisfaction, all necessary business and technical terms, specifications and requirements for the modification as determined by BNYM in its sole judgment (“Customization Order”) and Company’s agreement to pay all costs and expenses, including out-of-pocket expenses, associated with the customized modification (“Customization Fee Agreement”). All modifications developed and incorporated into the Licensed System pursuant to a Customization Order are referred to herein as “Company Modifications”. BNYM may make Company Modifications available to all users of the Licensed System, including BNYM, at any time after implementation of the particular Company Modification and any entitlement of Company to reimbursement on account of such action must be contained in the Customization Fee Agreement.

  • Absence of Changes or Events Except as set forth in Section 3.7 of the Company Disclosure Letter, since December 31, 2000 through the date of this Agreement, the Company and its Subsidiaries have not incurred any liability or obligation that has resulted or would reasonably be expected to result in a Company Material Adverse Effect, and there has not been any change in the business, financial condition or results of operations of the Company or any of its Subsidiaries which has had, or would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, and the Company and its Subsidiaries have conducted their respective businesses in the ordinary course consistent with their past practices.

  • Amendments; Modifications Neither this Agreement nor any term or provision in it may be changed, waived, discharged, rescinded or terminated orally, but only by an agreement in writing signed by the party against whom or which the enforcement of the change, waiver, discharge, rescission or termination is sought.

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