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...
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.
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.
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.
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.
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.
Changes / Variations
