Common use of Changes / Variations Clause in Contracts

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 will not provide to STADA re-published e-CTD sequences.

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 [***] months 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 [***] weeks 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 [***] week 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 will not provide to STADA re-published e-CTD sequences.

Changes / Variations. 8.1 6.1 In case of intended variations to the Dossier initiated by ALVOTECH after grant of the MAs, ALVOTECH will inform STADA at least [***] months 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 [***] weeks 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 which shall not unreasonably withhold or delay such its 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 6.2 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 6.3 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 6.4 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 6.5 Irrespective as to who will benefit from of 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 [***] week 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 will not provide to STADA re-published e-CTD sequences.