Process for Changes to Plan Sample Clauses

Process for Changes to Plan. (1) Changes with respect to the Initial Indication. Either party may propose changes with respect to the Initial Indication to the Joint Development Plan (which may include changes to the Shared Cost Budget) from time to time, via the JDC. The JDC shall discuss such changes to the Joint Development Plan (which may include changes to the Shared Cost Budget requested by either party). The JDC shall also review the Joint Development Plan (including such budgets) annually. Any changes to the Joint Development Plan with respect to the clinical protocol or territorial distribution of subjects for any clinical trial for the Initial Indication shall be made only by the mutual written approval of the parties. Any changes to the to the Shared Cost Budget, which increase such budget by [***], individually or aggregated together with other Shared Cost Budget changes that were not made by consensus, shall be made only by the mutual written approval of the parties. Any such mutual written approval may be either in the form of a JDC action unanimously approved by the parties, or in the form of a written amendment signed by authorized officers of both parties. If one party wishes to make a change to any element of the Joint Development Plan with respect to the Initial Indication, that is described above to require consensus between the parties, then the change shall not be made and the matter shall not be referred to arbitration in accordance with Article 15 nor shall it be justiciable. If one party wishes to make a change to any element of the Joint Development Plan for the Initial Indication other than in a way that require consensus between the parties as described above in this Section, the matter shall be resolved in accordance with Section 3.1(f). Each Party hereby acknowledges that amendments to clinical protocols that require submission to a Regulatory Authority or material changes in the territorial distribution of patients, even when not having a budgetary impact, can have a material impact on the utility of the resulting data to each Party in its respective territory, and therefore such changes in clinical protocols and territorial distributions in trials for the Initial Indication shall be made only by consensus. *** Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (2) [***] .
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Related to Process for Changes to Plan

  • Changes to Service We may, from time to time, modify the Service to reflect improvements and other changes and modifications to our network. In addition, we reserve the right to discontinue or limit Service as required to comply with or satisfy our obligations under applicable laws or regulations, including when changes to or interpretations of such laws and regulations have a material, adverse effect on the business, technical or economic feasibility of providing Service, as determined by us in our reasonable judgment.

  • Changes to Services The Parties acknowledge and agree that there will be changes to the scope of the Services during the Contract Period. The Customer may amend the Stories that are comprised within the Minimum Marketable Features of a Release at any time during the Release at no additional charge and without adopting the Change Control Procedure set out in Clause 28 above provided that: the Customer shall not be entitled to make any changes to the Stories that form the subject of a Sprint following the mutual agreement by the Parties of the Sprint Plan for that Sprint; new Stories and/or changes to existing Stories may only be introduced if: existing Stories with an equivalent number of Story Points are removed; or existing Stories are reduced in size by the equivalent number of Story Points, such that the total number of Story Points for the Release remains constant throughout the Release. The Supplier shall consider any request by the Customer to increase the number of Story Points for a Release, and may, subject to the Change Control Procedure set out at Clause 28, agree to such request.

  • Changes to Agreement We reserve the right to change any of the terms of this Agreement or any Specifications or Guidelines governing the Service at any time in our sole discretion. All changes will be effective upon posting to the Service. However, for all changes to this Agreement, excluding Specifications and Guidelines, we will post a notice of change for thirty (30) days. You are responsible for reviewing the notice and any applicable changes. YOUR CONTINUED USE OF THIS SERVICE FOLLOWING OUR POSTING OF ANY CHANGES WILL CONSTITUTE YOUR ACCEPTANCE OF SUCH CHANGES. 11) Prime Publishing Intellectual Property. Without our prior written consent, you may not use our intellectual property, including, without limitation, our trademarks, trade names, trade dress, or copyrighted material, in any manner. 12) Communications. Prime Publishing and its Affiliates may communicate with you in connection with the Service, electronically and in other Media, and you consent to such communications regardless of any "Customer Communication Preferences" (or similar preferences or requests) you may have indicated on the web sites of Prime Publishing or its Affiliates or by any other means. 13) Waiver. PRIME PUBLISHING AND ITS AFFILIATES WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO SUCH DAMAGES ARISING FROM BREACH OF CONTRACT OR WARRANTY OR FROM NEGLIGENCE OR STRICT LIABILITY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF WE HAVE BEEN ADVISED OF (OR KNEW OR SHOULD KNOWN OF) THE POSSIBILITY OF SUCH DAMAGES. 14) Disclaimer. PRIME PUBLISHING PROVIDES THE SERVICE "AS IS" WITHOUT WARRANTY OF ANY KIND. 15)

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • Changes to Fee Structure In the event of Listing, the Company and the Advisor shall negotiate in good faith to establish a fee structure appropriate for a perpetual-life entity.

  • Payment for Change of Scope Payment for Change of Scope shall be made in accordance with the payment schedule specified in the Change of Scope Order.

  • Procedure for Change of Scope 16.2.1 In the event of the Authority determining that a Change of Scope is necessary, it shall issue to the Concessionaire a notice specifying in reasonable detail the works and services contemplated thereunder (the “Change of Scope Notice”). 16.2.2 Upon receipt of a Change of Scope Notice, the Concessionaire shall, with due diligence, provide to the Authority such information as is necessary, together with preliminary Documentation in support of: (a) the impact, if any, which the Change of Scope is likely to have on the Project Completion Schedule if the works or services are required to be carried out during the Construction Period; and (b) the options for implementing the proposed Change of Scope and the effect, if any, each such option would have on the costs and time thereof, including a detailed breakdown by work classifications specifying the material and labour costs calculated in accordance with the schedule of rates applicable to the works assigned by the Authority to its contractors, along with the proposed premium/discount on such rates; provided that the cost incurred by the Concessionaire in providing such information shall be reimbursed by the Authority to the extent such cost is certified by the Independent Engineer as reasonable. 16.2.3 Upon receipt of information set forth in Clause 16.2.2, if the Authority decides to proceed with the Change of Scope, it shall convey its preferred option to the Concessionaire, and the Parties shall, with assistance of the Independent Engineer, thereupon make good faith efforts to agree upon the time and costs for implementation thereof. Upon reaching an agreement, the Authority shall issue an order (the “Change of Scope Order”) requiring the Concessionaire to proceed with the performance thereof. In the event that the Parties are unable to agree, the Authority may, by issuing a Change of Scope Order, require the Concessionaire to proceed with the performance thereof pending resolution of the Dispute, or carry out the works in accordance with Clause 16.5. 16.2.4 The provisions of this Agreement, insofar as they relate to Construction Works and Tests, shall apply mutatis mutandis to the works undertaken by the Concessionaire under this Article 16.

  • Attachment A, Scope of Services The scope of services is amended as follows:

  • Changes to the Services We provide Services in a multi- user environment and must therefore reserve the right to modify and discontinue Services. We may modify a Service at any time without degrading its functionality or security features For current subscriptions, we may degrade the functionality of a Service or discontinue a Service only in case of (i) legal requirements; (ii) changes in the Services imposed by Siemens’ subcontractors; (iii) the termination of our relationship with a provider of software and/or services used by us which are material for the provision of such Service; (iv) lack of customer acceptance; and/or (v) security risks. We will notify you of any material degradation of functionality or the discontinuation of a Service and the effective date at least 80 days prior to such change, and you may terminate the modified Service 30 days prior to the change effective date. In the event of such termination or discontinuation of a Service, we will refund any prepaid amounts for the applicable Service on a pro-rata basis for the remaining Subscription Term. We do not maintain prior versions of a Service.

  • CHANGES TO CONTRACT No amendment to the provisions of this Contract, other than a change to the Services in accordance with the procedure and provisions set out at Clause 29, shall be effective unless made in accordance with the procedures set out in this Clause 28 (“Change Control Procedure”). Subject to Clause 29.1, either Party may request a contract change by completing and sending a draft Contract Change Note in the form set out at Schedule 1 (“the Contract Change Note”) to the other Party giving sufficient information to enable the other Party to assess the extent of the change and any additional cost that may be incurred. The Party requesting the contract change shall bear the costs of preparation of the Contract Change Note. The Party receiving the request for a contract change shall respond to the request within five (5) Working Days (or such other period as may be agreed by the Parties) and if applicable, the Parties shall enter into discussions to discuss the proposed change and neither Party shall unreasonably withhold or delay consent to the other Party’s proposed changes to this Contract. Where the Customer has proposed a contract change and the Supplier is unable to provide the change, including where the Parties are unable to agree a change to the Contract Charges, the Customer may terminate this Contract with immediate effect. Following execution of the final Contract Change Note, the Supplier shall implement such change and be bound by the same provisions so far as is applicable, as though such change was stated in this Contract.

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