CBSB Initiated Changes Sample Clauses

CBSB Initiated Changes. Before CBSB may amend or modify the scope or performance of this Agreement, the Project, the Master Production Record, the Project Scope, the Project Schedule and Budget or any other services provided in accordance with this Agreement, CBSB shall prepare a Change Order describing in reasonable detail the nature of such change(s), and propose such Change Order to Tercica for Tercica’s review and written approval. All approved Change Orders shall be signed by the Project Manager of each Party or by such other authorized representatives of CBSB and Tercica that the Project Managers may designate. If any changes contemplated by a Change Order will impact the estimated timing, estimated cost or scope of the Project, CBSB shall provide Tercica with a written description of such impacts in the Change Order. If Tercica approves the Change Order notwithstanding CBSB’s notice of any resulting cost increase, Tercica shall reimburse CBSB for the cost of such changes as detailed in the Change Order. Upon CBSB and Tercica’s approval of the Change Order, the Change Order will be implemented as soon as it is commercially practical to do so. For the avoidance of doubt, any changes to the parts of the CBSB Facility, utilities, equipment or processes used by CBSB in its performance of the Project, including those relating to the manufacturing, storage, testing, shipping and cleaning procedures that are used by CBSB in the manufacture of Drug Substance under this Agreement, shall require a Change Order prior to implementation of such change(s). For the further avoidance of doubt, [*] Project Rates during the Term of this Agreement.
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Related to CBSB Initiated Changes

  • 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.

  • Implementation of Changes If Tenant: (i) approves in writing the cost or savings and the estimated extension in the time for completion of Landlord’s Work, if any, and (ii) deposits with Landlord any Excess TI Costs required in connection with such Change, Landlord shall cause the approved Change to be instituted. Notwithstanding any approval or disapproval by Tenant of any estimate of the delay caused by such proposed Change, the TI Architect’s determination of the amount of Tenant Delay in connection with such Change shall be final and binding on Landlord and Tenant.

  • Material Changes Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall not have been any material adverse change in the authorized capital stock of the Company or any Material Adverse Effect or any development that would reasonably be expected to cause a Material Adverse Effect, or a downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities) by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating of any of the Company’s securities (other than asset backed securities), the effect of which, in the case of any such action by a rating organization described above, in the reasonable judgment of the Agent (without relieving the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of the Placement Shares on the terms and in the manner contemplated in the Prospectus.

  • 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.

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

  • 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.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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

  • Notification of Material Changes The Advisor also agrees to give the Company prior written notice of any proposed material change in its Trading Approach and agrees not to make any material change in such Trading Approach (as applied to the Company) over the objection of the Company, it being understood that the Advisor shall be free to institute non-material changes in its Trading Approach (as applied to the Company) without prior written notification. Without limiting the generality of the foregoing, refinements to the Advisor’s Trading Approach and the deletion (but not the addition) of Commodities (other than the addition of Commodities then being traded (i) on organized domestic commodities exchanges, (ii) on foreign commodities exchanges recognized by the Commodity Futures Trading Commission (the “CFTC”) as providing customer protections comparable to those provided on domestic exchanges or (iii) in the interbank foreign currency market) to or from the Advisor’s Trading Approach, shall not be deemed a material change in the Advisor’s Trading Approach, and prior approval of the Company shall not be required therefor. The utilization of forward markets in addition to those enumerated in the Advisor’s Disclosure Document attached hereto as Exhibit C would be deemed a material change to the Advisor’s Trading Approach and prior approval shall be required therefor. Subject to adequate assurances of confidentiality, the Advisor agrees that it will discuss with the Company upon request any trading methods, programs, systems or strategies used by it for trading customer accounts which differ from the Trading Approach used for the Company, provided that nothing contained in this Agreement shall require the Advisor to disclose what it deems to be proprietary or confidential information.

  • PLAN CHANGES If a reinsured policy is changed to another plan of insurance that is not currently reinsured under this Agreement as defined in Schedule A, then the reinsurance, with respect to the reinsured policy, under this Agreement will cease as of the effective date of the change. If a policy that is not reinsured under this Agreement is changed to a plan that is reinsured under this Agreement as defined in Schedule A and the insured has met THE COMPANY’s underwriting requirements for the plan change, then reinsurance will commence as of the policy date of the new plan.

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