Changes / Variations Sample Clauses

Changes / Variations. 8.1 In case of intended variations to the Dossier initiated by ALVOTECH after grant of the MAs, ALVOTECH will inform STADA at least [***] in advance before the intended date of those changes coming into effect. ALVOTECH will provide STADA with sufficient details to start internal change control procedures at least [***] before submission of the variation and will provide STADA in time for submission with the necessary complete documentation for the variation procedure. However, every variation has first to be approved by STADA, and STADA shall not unreasonably withhold or delay such approval in writing. The changes to the Product notified to the Health Authorities shall only be implemented after successful completion of the variation procedures in the Territory or after written approval of STADA’s QC department. 8.2 In case of STADA-requested variations, which require additional work, like, but not limited to, development work, at ALVOTECH, such work shall be on behalf and for the account of STADA. The regulatory fees for such STADA-requested variations will be completely borne by STADA. 8.3 In case of ALVOTECH-requested variations, the work required shall be for the account of ALVOTECH, and the regulatory fees will be borne by ALVOTECH except that STADA shall bear the regulatory fees where STADA will have a direct benefit (e.g. lower Supply Price, longer shelf-life, or shorter lead times), which benefit must be of a reasonable and material value relative to the cost of such regulatory fees. 8.4 In case of all other variations, STADA shall bear all fees due to the Health Authority as a consequence of any change, variation or any modification that may be introduced in the Dossier and/or in the Marketing Authorisation. 8.5 Irrespective as to who will benefit from the changes, any changes to the Dossier by ALVOTECH will be communicated without delay and any additional appropriate regulatory documentation will be provided by ALVOTECH to STADA free of charge including but not limited to the preparation of relevant Dossier replacement pages which must comply with e-CTD-requirements. Additionally, ALVOTECH will provide to STADA (a) the updated, consolidated Dossier in e-CTD format within [***] after closure of the respective variation procedure in case such procedure was conducted by ALVOTECH on behalf of STADA and (b) after finalization of the registration procedure, copies of the e-CTD sequences that have been submitted to the Health Authority/-ies. ALVOTECH wi...
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Changes / Variations. 7.1 The Company may, by notice, change the scope of the Work to the extent it does not materially alter the original scope of the Work. If the change would affect the Work Price or any delivery date(s), the Contractor shall, within five (5) days after receipt of the requested change, so notify the Company and shall present adequate supporting documentation, and the Contractor shall not act on such change unless the Company so expressly directs, and the Parties shall meet and discuss a reasonable adjustment to the Work Price (based on agreed unit rates) or the delivery date(s) to reflect the impact of such change. If the Contractor does not request an adjustment within such five (5) days of receipt of direction to make changes, it shall not be entitled to any adjustment. 7.2 Unless the Company specifically instructs otherwise, Contractor shall not suspend performance of (the portion of) the Work not affected by a change directed under this Paragraph.
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Changes / Variations. 1. If a change is requested, the Client is responsible for submitting a written variation request instruction to Stormport Professional Services Limited Representative setting out the proposed change to the Works. The Client’s variation request instruction must specify the additional Works to be carried out by Stormport Professional Services Limited. Stormport Professional Services Limited will then provide a quotation for the variation works detailing the additional charge payable by the Client. If the Client’s instruction fails to properly specify the additional work, then the Client agrees to reimburse Stormport Professional Services Limited costs on a fair and reasonable basis. 2. The Client agrees that it is responsible for, and shall reimburse Stormport Professional Services Limited, any costs which arise as a consequence of the following (1) Client’s instruction to carry out additional work not specified in Stormport Professional Services Limited ’s Quotation; (2) Ground or physical conditions which were not reasonably foreseeable from the documents supplied by the Client to Stormport Professional Services Limited when Stormport Professional Services Limited submitted its Quotation; and (3) Unforeseen apparatus or cable configurations/joints are revealed when uncovered upon excavation.
Sample 1
Changes / Variations. Should the Client require any additional services, the Company will be pleased to discuss any request with the Client in order to meet the Client’s requirements. Details of the Contract Variation may include the effect upon the Fees, Disbursements etc. and upon the estimated Completion Date; where practical, then such details shall be agreed in writing prior to the Contract variation being carried out; where prior agreement is not practical then the Contract variation may be executed subsequently on reasonable terms. The Company shall be entitled to refuse to provide the additional services for its own reasons which might include lack of time or lack of competence in a particular area. Such refusal shall have no effect on the original engagement.
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Changes / Variations. 12.1 Customer shall have the right by written order to suspend work, to make changes from time to time in the services to be rendered or the materials to be furnished by Supplier hereunder or to change the delivery date. If any such change causes an increase or decrease in the cost of, or the time required for the performance of any work under this PO, an equitable adjustment shall be negotiated promptly and this PO shall be modified in writing accordingly. Any claim by the Supplier for adjustment under this section must be asserted within fourteen (14) days from the date of receipt by the Supplier of the notification of change; provided, however, that the Customer, if it so chooses, may receive and act upon any such claim asserted at any time prior to final payment hereunder. 12.2 Information, advice, or instructions given by Customer's technical personnel or other representatives shall be deemed expressions of personal opinion only, and shall not affect Customer's and Supplier's rights and obligations hereunder, unless set forth in a writing that is signed by Customer's purchasing representative and that states that it constitutes an amendment or change to this PO.
Sample 1
Changes / Variations. 7.1 Unless otherwise agreed in writing, the Contractor shall not deviate from quoted prices. 7.2 The Company may, by notice, change the scope of the Work to the extent it does not materially alter the original scope of the Work. If the change would affect the Work Price or any delivery date(s), the Contractor shall, within five (5) days after receipt of the requested change, so notify the Company and shall present adequate supporting documentation, and the Contractor shall not act on such change unless the Company so expressly directs, and the Parties shall meet and discuss a reasonable adjustment to the Work Price (based on agreed unit rates) or the delivery date(s) to reflect the impact of such change. If the Contractor does not request an adjustment within such five (5) days of receipt of direction to make changes, it shall not be entitled to any adjustment. 7.3 Unless the Company specifically instructs otherwise, Contractor shall not suspend performance of (the portion of) the Work not affected by a change directed under this Paragraph.
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Changes / Variations 
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Related to Changes / Variations

  • 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.

  • Amendments, Changes and Modifications Except as to the termination rights of both Parties as indicated in the Facilities Lease, this Site Lease may not be amended, changed, modified, altered or terminated without the written agreement of both Parties hereto.

  • F3 Variation The Authority may from time to time during the Contract Period, by written notice to the Contractor, request a variation of the Contract provided that such variation does not amount to a material change to it. Such a change is hereinafter called a “Variation”.

  • Amendments - Changes/Extra Work The Subrecipient shall make no changes to this Contract without the County’s written consent. In the event that there are new or unforeseen requirements, the County has the discretion with the Subrecipient’s concurrence, to make changes at any time without changing the scope or price of the Contract.‌ If County-initiated changes or changes in laws or government regulations affect price, the Subrecipient’s ability to deliver services, or the project schedule, the Subrecipient will give County written notice no later ten (10) days from the date the law or regulation went into effect or the date the change was proposed and Subrecipient was notified of the change. Such changes shall be agreed to in writing and incorporated into a Contract amendment. Said amendment shall be issued by the County-assigned Contract Administrator, shall require the mutual consent of all Parties, and may be subject to approval by the County Board of Supervisors. Nothing herein shall prohibit the Subrecipient from proceeding with the work as originally set forth or as previously amended in this Contract.

  • 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. (ii) All enhancements, improvements, changes, modifications or new features added to the TA2000 System however developed or paid for, including, without limitation, Client Requested Software (collectively, “Deliverables”), shall be, and shall remain, the confidential and exclusive property of, and proprietary to, DST. The parties recognize that during the Term of this Agreement the Fund will disclose to DST Confidential Information and DST may partly rely on such Confidential Information to design, structure or develop one or more Deliverables. Provided that, as developed, such Deliverable(s) contain no Confidential Information that identifies the Fund or any of its investors or which could reasonably be expected to be used to readily determine such identity, (i) the Fund hereby consents to DST’s use of such Confidential Information to design, to structure or to determine the scope of such Deliverable(s) or to incorporate into such Deliverable(s) and that any such Deliverable(s), regardless of who paid for it, shall be, and shall remain, the sole and exclusive property of DST and (ii) the Fund hereby grants DST a perpetual, nonexclusive license to incorporate and retain in such Deliverable(s)

  • Changes; Amendments This Agreement may be changed or amended only by written instrument signed by both parties.

  • Changes by us 2.1 We may vary any details of this agreement or a direct debit request at any time by giving you at least fourteen (14) days’ written notice.

  • Deletions During the Contract Term, the Department reserves the right to delete Commodities, including but not limited to, Groups, Manufacturers or brand names, Representative Models, from this agreement by removing them from Exhibit B, Price Sheet(s) (C.1 – C.6). Commodities may be removed at the sole discretion of the Department.

  • CHANGES AND AMENDMENTS A. Any alterations, additions, or deletions to the terms of this Agreement, which are required by changes in federal or state law or by regulations, are automatically incorporated without written amendment hereto, and shall become effective on the date designated by such law or by regulation. B. To ensure the legal and effective performance of this Agreement, both parties agree that any amendment that affects the performance under this Agreement must be mutually agreed upon and that all such amendments must be in writing. After a period of no less than 30 days subsequent to written notice, unless sooner implementation is required by law, such amendments shall have the effect of qualifying the terms of this Agreement and shall be binding upon the parties as if written herein.

  • CHANGES TO THESE TERMS We may need to change these terms to reflect changes in law or best practice or to deal with additional features which we introduce or to meet specific requests from our Customers. We will give you at least ten (10) days notice of any change by sending you an SMS or email with details of the change or notifying you of a change when you next start the App. If you do not accept the notified changes you will not be permitted to continue to use the App and the Service.

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