Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date. 17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate. 17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice: (a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party; (b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee; (c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product; (d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party; (e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 2025 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion); (f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date. 17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA: (a) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; (b) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; (c) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; (d) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; (e) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded. 17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights. 17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement. 17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if: (a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or (b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or (c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries. 17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded. 17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis). 17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination). 17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date.
17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] months at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 31 December 2025 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] days after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] weeks after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] For these purposes, the sales shall be determined according to data provided by XXXXX IQXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date.
17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June April 2025 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] days after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date.
17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 2025 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within within[***] after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] ]. For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidentiality Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 17.1. This Agreement shall become effective upon may be terminated forthwith by either party by notice in writing from the Effective Date.
17.2 Upon expiration party not at fault if any of the Exclusivity Period, in respect following events shall occur:
a) if there shall be an assignment for the benefit of creditors of the Territoryother party, except as otherwise stated in this Article 17or any insolvency, (a) STADA will keep bankruptcy or receivership proceeding on the Dossier (and part of the other party, or it shall be unable to pay its rights debts, or shall cease to use the Dossier), (carry on business;
b) if the rights granted to STADA other party shall be in material breach under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject and shall fail to written notice:
remedy such breach within thirty (a30) by days from receipt of notice in writing from the non-defaulting Party party specifying such default;
c) if either party is for any reason (other than one directly attributable to the other Party commits party), whether due to a material breach force majeure event under Section 14 or otherwise, prevented from performing its obligations hereunder for a period of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 2025 (date of positive EC decision) (which date shall be extended by up to three (3) consecutive months if it is likely that such extension or for a total period of time has a reasonable prospect six (6) months in any period of resulting in a positive opinion);
twelve (f12) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Dateconsecutive months.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in Reseller does not meet the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country agreed upon sales volumes consecutively for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appealyears, or if the Health Authority or Reseller does not comply with the agreed upon personnel and financial requirements during any other responsible authority declines to grant reimbursement status. two consecutive calendar fiscal year.
e) In the case of termination the Supplier, if all or substantially all of Reseller’s assets or capital stock is acquired by STADA under Article 17.7(aa developer, licensor or provider of software or services that directly competes with the Xxxxxx Software and/or related services (a “Xxxxxx Competitor”).
f) In the case of the Supplier, if the Reseller has not fully complied with its obligations according to Section 11.1 e), p), q) or (cs) and/or 11.2).
g) If either party violates section 26 or 27.
17.2. This Agreement shall automatically terminate if, for non-EU countrieswhatever reason, ALVOTECH shall refund the Supplier’s rights to STADA an amount calculated according license, market, distribute and support the Software are terminated, or if, and to the following scheme: refund amount = [***] For these purposesextent, the sales shall Xxxxxx Group should be determined according prohibited from conducting business with the Reseller due to data provided by XXXXX Xxxxxxxxxx XxxX & Xxany applicable export restrictions or trade embargo. XXXIf however such rights to license, Xxxxxxxxx/Xxxxmarket, Xxxxxxx. In all cases of termination under this Article 17.7distribute and support are terminated only as concern certain sub-licensed Third Party Software, the effects set out in Article 17.5 shall apply, but termination will only for apply to the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countriesResellers right to continue to distribute such third party software.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination 17.3. For purposes of this Agreement, non-payment beyond the stipulated date and any extensions thereof shall always be deemed a material breach.
17.4. However, any reimbursements made in accordance with the terms The expiration or termination of this Agreement shall be deducted from without prejudice to the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one rights of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts parties accrued but unpaid hereunder prior up to the date of such expiration or termination).
17.11 In 17.5. Upon expiration or termination (for whatever reason) of this Agreement, the Reseller shall immediately cease all marketing activities with respect to the Software and discontinue any case Maintenance services to customers except to the extent required by the Supplier. The Supplier shall fulfill all orders accepted prior to termination and shall assume or cause a third party to assume support obligations to customers not retained by the Reseller. The Reseller shall also return or destroy (as the Supplier shall instruct) no later than fourteen (14) days thereafter, all Software, documentation, technical information and any other data supplied to the Reseller during the term of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADAand any copies made of the whole or any part of the same and the Reseller shall furnish the Supplier with a Certification, STADAcertifying that the same has been done. The Reseller shall also cease all usage of or reference to the Xxxxxx Group’s, Xxxxxx’x customers’ or its third parties’ name(s) or trademark(s) (or any name under which the Xxxxxx Group, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECHcustomers or third parties do business) for any purpose including but not limited to, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted hereinany marketing, STADA is entitled to use and keep the Dossier and the relevant MAspublic relations, advertising, display or other business purpose.
Appears in 1 contract
Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date.
17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June November 2025 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] ]. For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 15.1 This Agreement shall become effective upon the Effective Date.
17.2 15.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 1715, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 15.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] months at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 13 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 2025 31.12.2021 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by either Party if the milestone as described in Article 7.1 is not reached, i.e. that the defined end points as per the clinical trial protocol are not met and considered negative by ALVOTECH and STADA; or
(g) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date31 March 2020 or, if later, by such later date (up to a maximum of a further six (6) months) as is necessary to accommodate the demands of the Development Plan.
17.4 15.4 The effects of termination by STADA according to Article 17.3(a15.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 8 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a15.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 7 reduced by any reimbursements in accordance with Article 11.15 9.13 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 7 reduced by any reimbursements in accordance with Article 11.15 9.13 (if any) ), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 7 reduced by any reimbursements in accordance with Article 11.15 9.13 (if any), if the termination takes place during the [***] ([***]) marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 7 reduced by any reimbursements in accordance with Article 11.15 9.13 (if any), if the termination takes place during the [***] ([***]) marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 7 reduced by any reimbursements in accordance with Article 11.15 9.13 (if any), if the termination takes place during the [***] ([***]) marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made paid in accordance with Article 9.4, 7 shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 15.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a15.3 (a) or (b) or (d) (provided that, in case of termination under Article 17.3(a15.3 (a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement), or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c15.3 (c), (e) or (fg), or (iii) either Party according to Article 15.3(f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b15.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a15.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c15.3(c), (e) or (fg), or if either Party terminates according to Article 15.3(f). In case the Parties cannot agree on such standard royalties for said trademark within [***] days after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] weeks after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 15.6 In addition to the effects set out in Article 17.515.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c15.3(c), (e) or (fg) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 7 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 15.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 14.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a15.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] ]. For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.715.7, the effects set out in Article 17.5 15.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 15.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 15.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 15.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 15.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidentiality Agreement (Alvotech Lux Holdings S.A.S.)
Termination and Expiration. 17.1 This Agreement shall become effective upon the Effective Date.
17.2 Upon expiration of the Exclusivity Period, in respect of the Territory, except as otherwise stated in this Article 17, (a) STADA will keep the Dossier (and its rights to use the Dossier), (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become non-exclusive, fully paid-up and continue in force on a perpetual basis (but remain subject to the restrictions contained therein), and (c) the Exclusive Purchase Obligation shall terminate.
17.3 Except as otherwise provided in this Agreement, this Agreement can be terminated with immediate effect subject to written notice:
(a) by the non-defaulting Party if the other Party commits a material breach of this Agreement and, in the case of a breach capable of remedy, does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(b) by the non-defaulting Party if the other Party states or admits in writing that it is unable to pay its current obligations in the ordinary course of business as they generally become due, declares bankruptcy, assigns all its assets for the benefit of creditors, undergoes a corporate reorganization prompted by insolvency or appoints receiver or trustee;
(c) by STADA in case the Products will not benefit from a registered shelf life of at least [***] months at the date of grant of the first MA on behalf of STADA or its Affiliate and/or the ongoing-stability program in accordance with GMP does not confirm such stability of the Product;
(d) by the Party to whom a warranty according to Article 15 is given and such warranty turns out to be incorrect and the breaching Party does not remedy the situation within sixty (60) calendar days of receiving written notice of default from the other Party;
(e) by STADA if an EU-wide Marketing Authorisation by way of the CP is not granted by 30 June 2025 31 August 2024 (date of positive EC decision) (which date shall be extended by up to three (3) months if it is likely that such extension of time has a reasonable prospect of resulting in a positive opinion);
(f) by STADA if the Dossier is not delivered to STADA by Target Dossier Delivery Date.
17.4 The effects of termination by STADA according to Article 17.3(a) or (b) or (d) shall be that (a) STADA will keep the Dossier (and its rights to use the Dossier), and upcoming and granted MAs, (b) the rights granted to STADA under Articles 2.1 through 2.3 shall become [***] (but remain subject to restrictions contained therein) and STADA shall not be required to make any further payments to ALVOTECH under this Agreement (other than pursuant to Article 10 if the Supply Agreement remains in place), and (c) STADA shall be [***]. Further, in case of termination by STADA according to Article 17.3(a) or (d), provided that the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of STADA to exploit or exercise its rights under this Agreement, then ALVOTECH shall reimburse to STADA:
(a) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place prior to or during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(b) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any) if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(c) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(d) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany;
(e) [***] percent ([***]%) of the payments paid in accordance with Article 9.4 reduced by any reimbursements in accordance with Article 11.15 (if any), if the termination takes place during the [***] marketing year of the Product in the initial Exclusivity Period for Germany; and after expiration of the initial Exclusivity Period for Germany, the effects mentioned above shall remain, but no reimbursement of the payments made in accordance with Article 9.4, shall become due. Any reimbursement shall be fully credited against any damages claims awarded.
17.5 The effects of termination by (i) ALVOTECH as terminating Party according to Article 17.3(a) or (b) or (d) (provided that, in case of termination under Article 17.3(a) or (d), the relevant breach of this Agreement including any warranty is of a material nature and has an adverse effect on the ability of ALVOTECH to benefit from the rights granted under this Agreement, or (ii) STADA as terminating Party according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that STADA shall return to ALVOTECH, without retaining any copy, the Dossier (if any), together with any other documentation delivered by ALVOTECH in connection with the Products, except for copies which are required to be retained subject to law. In addition upon written request by ALVOTECH, STADA shall immediately assign and transfer any and all rights to the MAs (or to any MA applications, as the case may be) to ALVOTECH or ALVOTECH’s designee, at no cost for ALVOTECH whatsoever and STADA shall have no further rights under this Agreement or in any other way with respect to the Dossier, any IP Rights under this Agreement, including any Created Product IP Rights, Owned Created IP Rights, Product IP Licensed Rights, and Manufacturing Product ex-Territory IP Rights, the Products and/or the MAs for the Products. In addition, STADA, on behalf of itself and its Affiliates, (a) hereby assigns to ALVOTECH, all of STADA’s right, title, and interest in and to all Product IP Owned Rights and Created Product IP Rights, and (b) STADA hereby grants to ALVOTECH, a non-exclusive, royalty-free (except for any royalties for the product trademarks as set out herein), fully-paid up and sublicensable right (through multiple tiers), to freely exploit any other IP Rights owned by STADA or its Affiliates relating to the Product solely to the extent necessary for the manufacture, marketing, use and sale of the Product in the Territory in a form substantially similar to the commercialisation as performed or envisaged by STADA, and agrees to introduce ALVOTECH and its designees with the aim to obtain any such licenses from any sublicenses or subcontractors of STADA or its Affiliates to the extent necessary for the manufacture, marketing, use, or sale of the Products in the Territory. Such license granted under this Article 17.5(b) shall exclude rights to any trademarks, trade dress of use of the company names of STADA or its Affiliates; provided that in the event termination occurs after launch of the Product in a country in the Territory, then STADA hereby grants ALVOTECH an exclusive and sublicensable right (through multiple tiers), to use the product trademark under which the Product was being commercialized in such country for the sole purpose of manufacturing, marketing, using, or selling the Products in the Territory, and the Parties will negotiate in good faith a trademark license agreement with standard royalties customary in the pharmaceutical industry for a deal of this size and commercial potential of the Product, addressing the enforcement and protection of such trademark for the benefit of ALVOTECH, or if mutually agreed to, an assignment of such trademark to ALVOTECH. The product trademark license shall be royalty-free and fully paid up, if ALVOTECH is the terminating Party according to Article 17.3(a) or (b) or (d), and shall bear said standard royalties as set out herein, if STADA is the terminating Party according to Article 17.3(c), (e) or (f). In case the Parties cannot agree on such standard royalties for said trademark within [***] days after start of the negotiation, either Party may request that the president of the International Chamber of Commerce in Frankfurt, Germany, as arbitrator (or any other person nominated by said president and acting as arbitrator) determines the same in good faith taking into consideration the nature of the license in the pharmaceutical industry, the size and commercial potential of the Product. For this purpose, both Parties may submit a confidential proposal to the arbitrator setting out the amount of such royalty rate within the time period set by the arbitrator which shall not exceed [***] weeks after the arbitrator has been appointed or invoked. The arbitrator shall only be entitled to choose between one of the two proposals and shall select only such proposal which he considers in good faith the most appropriate one in light of the criteria set out herein. The determination of the arbitrator of the royalty rate shall be binding in any court of competent jurisdiction. The total expense including reasonable attorney fees of such arbitration shall be paid by the unsuccessful Party. STADA will cooperate with ALVOTECH and its representatives to effectuate the transfer, vesting, and recordal of ALVOTECH’s rights in and to such transferred IP Rights.
17.6 In addition to the effects set out in Article 17.5, the effects of termination by STADA according to Article 9.7(b) or Article 17.3(c), (e) or (f) shall be that ALVOTECH shall reimburse STADA all payments already made under Article 9.4 and all regulatory fees and any other costs related to such MAs or application already paid under this Agreement.
17.7 This Agreement can be terminated by STADA on a country-by-country basis for any country of the Territory with immediate effect by giving written notice to ALVOTECH if:
(a) ALVOTECH fails to assist STADA in answering adequately any deficiency letter issued by any relevant Health Authority so that a MA for at least one strength (pack size) of the Product cannot be obtained in such country; or
(b) Article 16.3 applies in the country concerned, and the prospects of the Third Party lawsuit are that, on the balance of probabilities, such lawsuit will succeed; or
(c) the Health Authorities of the respective country decline to successfully conclude a registration procedure in a national procedure and to grant a MA for the Product on the basis of the Dossier, or the performance of ALVOTECH is not in line with the European state of the art in regulatory affairs in running/or supporting the application procedures, independent of any possibility of appeal, or if the Health Authority or any other responsible authority declines to grant reimbursement status. In case of termination by STADA under Article 17.7(a) or (c) for non-EU countries, ALVOTECH shall refund to STADA an amount calculated according to the following scheme: refund amount = [***] For these purposes, the sales shall be determined according to data provided by XXXXX Xxxxxxxxxx XxxX & Xx. XXX, Xxxxxxxxx/Xxxx, Xxxxxxx. In all cases of termination under this Article 17.7, the effects set out in Article 17.5 shall apply, but only for the country(ies) concerned, and the Exclusive Purchase Obligation shall terminate automatically for the specific terminated country/countries.
17.8 The terms and conditions of this Article shall not limit any rights for damages of either Party subject to a breach of contract by the other Party in case of termination of this Agreement. However, any reimbursements made in accordance with the terms of this Agreement shall be deducted from the amount of any damage claim awarded.
17.9 For clarification: in all events of termination the non-compete obligation shall also terminate (for the respective country, if termination occurs on a country-by-country basis).
17.10 Upon termination of this Agreement for any reason, nothing shall be construed to release one of the Parties from any of its obligations or liabilities hereunder arisen until the date of termination (including without limitations its obligations to pay any and all fees or other amounts accrued but unpaid hereunder prior to the date of such termination).
17.11 In any case of termination, except in the event that ALVOTECH terminates this Agreement for material breach by STADA, STADA, its Affiliates and/or its Distributors are entitled to sell their remaining stock of the Product purchased from ALVOTECH, provided that all outstanding invoices of ALVOTECH for the Product supply have been paid by STADA. As long as necessary for the sell-out of the remaining stock as permitted herein, STADA is entitled to use and keep the Dossier and the relevant MAs.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)