Non-Regulatory Changes Sample Clauses

Non-Regulatory Changes. All non-regulatory required modifications, changes, additions or deletions to the (1) MBRs or Specifications; (2) the Client Product-specific Xxxxxx SOPs; (3) storage or distribution Specifications of the Client Product; (4) composition, source, or manufacturing of any raw material for Client Product; (5) method of producing, processing or testing Client Product; (6) subcontractors (other than independent contractor providing ancillary services in the ordinary course of Althea’s operations) used for producing, processing or testing Client Product; or (7) the Facility which Xxxxxx intends to carry out must be evaluated and documented by Xxxxxx. Prior to implementation of any such change, Xxxxxx agrees to obtain Client’s prior written consent to do so, which consent shall not be unreasonably withheld or delayed.
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Non-Regulatory Changes. In the event either Company or Provider requests a change (other than a Regulatory Change) [***]. Provider shall have no obligation to perform, and Company shall have no obligation to pay for, any additional or modified Services absent written agreement with respect thereto in a Work Order or one or more Change Orders agreed to and executed by Company, Legend and Provider as set forth in this Agreement.

Related to Non-Regulatory Changes

  • Regulatory Changes If any legislative, regulatory, judicial or other legal action (other than an Amendment to the Act, which is provided for in Section 29.3) materially affects the ability of a Party to perform any material obligation under this Agreement, a Party may, on thirty (30) days written notice to the other Party (delivered not later than thirty (30) days following the date on which such action has become legally binding), require that the affected provision(s) be renegotiated, and the Parties shall renegotiate in good faith such mutually acceptable new provision(s) as may be required; provided that such affected provisions shall not affect the validity of the remainder of this Agreement.

  • Regulatory Change Without limiting the effect of the provisions of Section 5.01(a), in the event that at any time (by reason of any Regulatory Change or any other circumstances arising after the Closing Date affecting (A) any Lender, (B) the London interbank market or (C) such Lender’s position in such market), the Adjusted LIBOR, as determined in good faith by such Lender, will not adequately and fairly reflect the cost to such Lender of funding its LIBOR Loans, then, if such Lender so elects, by notice to the Borrower and the Administrative Agent, the obligation of such Lender to make additional LIBOR Loans shall be suspended until such Regulatory Change or other circumstances ceases to be in effect (in which case the provisions of Section 5.04 shall be applicable).

  • STATUTORY CHANGES All references to sections of the Exchange Act or the Code shall be deemed also to refer to any successor provisions to such sections.

  • 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.

  • Project Changes 1.8.1. All changes shall be administered per the UGC. 1.8.2. Upon authorization by the Owner, the Owner or Architect/Engineer will prepare and issue all changes to the Contract affecting cost, scope and/or time as a formal Change Order to the Contract on the standard University of Texas MD Xxxxxxxx Cancer Center Change Order form. The Change Order may include separate change issues, identified as Change Proposals and field orders. 1.8.3. Upon authorization by the Owner, Change Proposals may be issued to the Architect/Engineer for pricing by the Contractor. Contractor shall submit pricing to the Owner within twenty-one (21) days and pricing shall be indicated on the standard Owner "Change in Work Cost Analysis" ("Cost Analysis") form provided in the Pre-Construction Conference Brochure. Contractor may not include a Change Proposal within a Change Order unless the Owner has accepted the Change Proposal. 1.8.3.1. The Contractor shall summarize all costs for each change at each level of subcontractor and supplier by preparing the "Cost Analysis" form, and shall provide each subcontractor's cost summary on separate "Cost Analysis" forms as backup. Additional support documentation from both the Contractor and Contractor’s subcontractors is encouraged, but such will not replace use of the standard form. 1.8.3.2. When the Contractor believes it is entitled to a time extension, Contractor shall so state as part of Contractor’s response to the Change Proposal, including a justifica- tion for a time extension. Owner may grant time extensions only if a Change Proposal affects the activities on the Longest Path of an Owner approved Work Progress Schedule; i.e., when the Work impacts the "Contract Substantial Completion Date". 1.8.3.3. If the Owner’s Project Manager and Contractor cannot mutually agree upon a fair and reasonable cost and time settlement, the Owner’s Project Manager may: 1) Reject the quotation and void the Change Proposal, 2) Issue instructions to the Contractor to proceed on a time and material basis for a price to be determined later not to exceed a fixed maximum dollar and time, or 3) Issue a Unilateral Change Order. 1.8.3.4. The Owner’s Construction Inspector and/or Owner’s Project Manager may issue field orders directly to the Contractor for minor changes to the Contract, which can be negotiated in the field. Pricing backup is at the discretion of the Owner’s Construction Inspector, but pricing backup is required for any field order, the pricing backup is to be outlined on the "Cost Analysis" form. When the Owner and Contractor have signed the field order, the Work is authorized and the field order may be included in the next Change Order. 1.8.4. Request for payment for Change Order work may be submitted only after the Change Order has been fully executed.

  • Service Changes PBI may modify its Service by giving written notice to you (a “Service Change Notice”), which will state whether the change is material. After receiving a Service Change Notice, if the change is material, you may terminate Service by giving us a termination notice at the address indicated in Section 21 or you may create a case at xxxxxxxxxxx.xxx/xx/xxxxxxx-xx.xxxx (follow the instructions under “how to create a case”).

  • Economic Uniformity; Changes in Law (A) At the election of the General Partner with respect to any taxable period ending upon, or after, the termination of the Subordination Period, all or a portion of the remaining items of Partnership gross income or gain for such taxable period, after taking into account allocations pursuant to Section 6.1(d)(iii), shall be allocated 100% to each Partner holding Subordinated Units that are Outstanding as of the termination of the Subordination Period (“Final Subordinated Units”) in the proportion of the number of Final Subordinated Units held by such Partner to the total number of Final Subordinated Units then Outstanding, until each such Partner has been allocated an amount of gross income or gain that increases the Capital Account maintained with respect to such Final Subordinated Units to an amount that after taking into account the other allocations of income, gain, loss and deduction to be made with respect to such taxable period will equal the product of (1) the number of Final Subordinated Units held by such Partner and (2) the Per Unit Capital Amount for a Common Unit. The purpose of this allocation is to establish uniformity between the Capital Accounts underlying Final Subordinated Units and the Capital Accounts underlying Common Units held by Persons other than the General Partner and its Affiliates immediately prior to the conversion of such Final Subordinated Units into Common Units. This allocation method for establishing such economic uniformity will be available to the General Partner only if the method for allocating the Capital Account maintained with respect to the Subordinated Units between the transferred and retained Subordinated Units pursuant to Section 5.5(c)(ii) does not otherwise provide such economic uniformity to the Final Subordinated Units. (B) With respect to an event triggering an adjustment to the Carrying Value of Partnership property pursuant to Section 5.5(d) during any taxable period of the Partnership ending upon, or after, the issuance of IDR Reset Common Units pursuant to Section 5.11, after the application of Section 6.1(d)(x)(A), any Unrealized Gains and Unrealized Losses shall be allocated among the Partners in a manner that to the nearest extent possible results in the Capital Accounts maintained with respect to such IDR Reset Common Units issued pursuant to Section 5.11 equaling the product of (1) the Aggregate Quantity of IDR Reset Common Units and (2) the Per Unit Capital Amount for an Initial Common Unit. (C) With respect to any taxable period during which an IDR Reset Common Unit is transferred to any Person who is not an Affiliate of the transferor, all or a portion of the remaining items of Partnership gross income or gain for such taxable period shall be allocated 100% to the transferor Partner of such transferred IDR Reset Common Unit until such transferor Partner has been allocated an amount of gross income or gain that increases the Capital Account maintained with respect to such transferred IDR Reset Common Unit to an amount equal to the Per Unit Capital Amount for an Initial Common Unit. (D) For the proper administration of the Partnership and for the preservation of uniformity of the Limited Partner Interests (or any class or classes thereof), the General Partner shall (1) adopt such conventions as it deems appropriate in determining the amount of depreciation, amortization and cost recovery deductions; (2) make special allocations of income, gain, loss, deduction, Unrealized Gain or Unrealized Loss; and (3) amend the provisions of this Agreement as appropriate (x) to reflect the proposal or promulgation of Treasury Regulations under Section 704(b) or Section 704(c) of the Code or (y) otherwise to preserve or achieve uniformity of the Limited Partner Interests (or any class or classes thereof). The General Partner may adopt such conventions, make such allocations and make such amendments to this Agreement as provided in this Section 6.1(d)(x)(D) only if such conventions, allocations or amendments would not have a material adverse effect on the Partners, the holders of any class or classes of Limited Partner Interests issued and Outstanding or the Partnership, and if such allocations are consistent with the principles of Section 704 of the Code.

  • Policy Changes 9 a. NOTICE...............................................................9 b. INCREASES............................................................9 c.

  • Contract Changes Changes may not be made in the terms and conditions of this contract without the agreement and written permission of the Director of Residence Life or the Director’s designee.

  • 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.

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