Grant of Rights Ownership. 2.1 Subject to the terms and conditions set forth in this Agreement, including without limitation, Article 2.2, Article 2.3, Article 2.4, Article 2.5, Article 16 and Article 17, ALVOTECH hereby grants to STADA: (a) the right to own an equal and undivided joint ownership interest (with ALVOTECH or its applicable Affiliate(s)) in the Territory in and to (i) the Product IP Owned Rights and (ii) the Created Product IP Rights; (b) the sub-licensable right (through multiple tiers) to the Product IP Licensed Rights; (c) the right under Manufacturing Product ex-Territory IP Rights; and (d) the right to sublicense or subcontract any or all of the rights granted in accordance with Article 2.1(a), (b) and (c) to any Distributors and/or any other Third Party in the Territory, provided further that: (i) STADA remains liable at all times towards ALVOTECH for the performance and any act or omission of any such permitted sublicensee or subcontractor; (ii) STADA secures all appropriate covenants, obligations and rights from any such permitted sublicensee or subcontractor to ensure that it will comply with all of STADA’s covenants and obligations to ALVOTECH under this Agreement to the extent that the sublicensee or subcontractor performs such covenants and obligations (including without limitation Article 12); (iii) any rights licensed by a Third Party and sublicensed hereunder shall be subject to the terms and conditions of such Third Party agreement; and (iv) with respect to the manufacturing rights granted under Article 2.1(a), (b) or (c), STADA may only engage any Third Party toll manufacturer in the ordinary and usual course of STADA’s business. 2.2 Subject to all other applicable terms and conditions of this Agreement, and provided STADA is not in an uncured material breach of this Agreement and/or the Supply Agreement, STADA’s rights under Article 2.1 with respect to the Products in the Territory shall at all times be: (a) in the case of any manufacturing related rights, non-exclusive; and (b) in the case of using, marketing, promoting, selling, offering, importing, and/or distributing the Products: (i) Semi-Exclusive Rights during the Exclusivity Period in the Semi-Exclusive Countries; (ii) Exclusive Rights during the Exclusivity Period in all other countries of the Territory, and (iii) non-exclusive in all countries of the Territory following the expiration or early termination of the Exclusivity Period. 2.3 The rights under Article 2.1 shall at all times be used (and only used) for the purpose of: (a) obtaining and using one MA for the Product(s) per country of the Territory; and (b) using, clinically testing and/or having clinically tested (as described in Article 4.4), marketing and/or having marketed, promoting or having promoted, selling and/or having sold, offering and/or having offered for sale, importing and/or having imported, and/or distributing and/or having distributed the Products under any trademarks of STADA and/or its Affiliates and/or its Distributors in the Territory; and (c) manufacturing Products inside and/or outside the Territory solely for use in the Territory, [***] prior to the expiry of the Exclusivity Period subject to prior notification to ALVOTECH. 2.4 STADA hereby grants to ALVOTECH: (a) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, for: (i) all purposes outside of the Territory; and (ii) all purposes inside the Territory other than with respect to the Products; (b) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, to Develop the Products inside and outside the Territory and carry out its obligations under this Agreement in the Territory in accordance with this Agreement, including submitting to EMA a CP for the Products in the Territory; (c) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, the Product IP Licensed Rights, and the Manufacturing Product ex-Territory IP Rights to manufacture the Products, provided that: (i) [***] prior to the expiry of the Exclusivity Period, STADA shall, subject to prior notification to ALVOTECH, be entitled to manufacture validation batches of the Products inside or outside the Territory for the sole purpose of using such Products in the Territory after expiry of the Exclusivity Period; and (ii) after expiry of the Exclusivity Period, STADA shall have the non-exclusive right to manufacture the Products inside or outside the Territory for the sole purpose of marketing, promoting, selling and distributing the Products in the Territory; and (d) the perpetual, fully-paid up, royalty-free, Semi-Exclusive (ALVOTECH or [***] designated by it, but not more, in addition to STADA and its Affiliates or Distributors) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, and the Product IP Licensed Rights for using, marketing, promoting, selling, offering, importing, and/or distributing the Products in the Semi-Exclusive Countries. (a) Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates and Third Parties working on their behalf, to so disclose, the invention, discovery, development or other making of any Created Product IP Rights by such Party or any of its Affiliates or Third Parties acting on their behalf. Each Party assigns, and shall cause its Affiliates and Third Parties acting on behalf of such Party and such Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Created Product IP Rights as is necessary to fully effect the joint ownership provided for in Article 2.1(a), including all rights of action and claims for damages and benefits arising due to past and present infringement of such rights. (b) Alvotech assigns, and shall cause its Affiliates to so assign, one-half of its right, title and interest in and to any Product IP Owned Rights to STADA to effect the joint ownership provided for in Article 2.1(a). Each Party will cooperate with the other Party and its representatives to effectuate such joint ownership rights in and to the Product IP Owned Rights and Created Product IP Rights, including without limitation, executing any documents in connection therewith. For clarity, all IP Rights created by a Party other than Created Product IP Rights (which shall be jointly owned pursuant to Article 2.1(a)), shall be owned by the Party creating such IP Rights. 2.6 Subject to all other applicable terms and conditions of this Agreement, STADA will become the owner of all Marketing Authorisations obtained by direct application of STADA, its Affiliates or by applications on behalf of STADA or its Affiliates submitted by ALVOTECH or a regulatory consultant chosen by STADA or its Affiliates. For the avoidance of doubt, this will not apply to MAs which ALVOTECH, its Affiliates or their distributors or agents may apply for when exercising ALVOTECH’s rights in the Semi-Exclusive Countries. In case of sublicensing according to Article 2.1(d) above STADA shall be entitled to transfer a further copy of the Dossier to the respective sublicensee for the relevant country of the Territory. 2.7 STADA is entitled to use and retain the copy of the Dossier (including all variations) it receives pursuant to this Agreement in accordance with all rights granted under (and subject to all terms of) this Agreement and the Supply Agreement. 2.8 For the avoidance of doubt, and without prejudice to the licences to STADA as set out in Articles 2.1 through 2.3 and to ALVOTECH as set out in Article 2.4, it is acknowledged that, as between the Parties, ALVOTECH retains full ownership or rights of all and any Product IP Licensed Rights and Manufacturing Product ex-Territory IP Rights licensed to STADA under this Agreement, and use of any Product IP Licensed Rights or Manufacturing Product ex-Territory IP Rights are subject to the terms and conditions of the applicable Third Party agreement. Except where Product IP Owned Rights and Created Product IP Rights are exclusively and/ or Semi-Exclusively licensed to the other Party under this Agreement, each Party may exploit, license, or sublicense (through multiple tiers) Product IP Owned Rights and Created Product IP Rights without the consent of, or a duty of accounting to, the other Party.
Appears in 3 contracts
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.), Confidential Agreement (Alvotech Lux Holdings S.A.S.), Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Grant of Rights Ownership. 2.1 Subject to the terms and conditions set forth in this Agreement, including without limitation, Article 2.2, Article 2.3, Article 2.4, Article 2.5, Article 16 and Article 17, ALVOTECH hereby grants to STADA:
(a) the right to own an equal and undivided joint ownership interest (with ALVOTECH or its applicable Affiliate(s)) in the Territory in and to (i) the Product IP Owned Rights and (ii) the Created Product IP Rights;
(b) the sub-licensable right (through multiple tiers) to the Product IP Licensed Rights;
(c) the right under Manufacturing Product ex-Territory IP Rights; and
(d) the right to sublicense or subcontract any or all of the rights granted in accordance with Article 2.1(a), (b) and (c) to any Distributors and/or any other Third Party in the Territory, provided further that:
(i) STADA remains liable at all times towards ALVOTECH for the performance and any act or omission of any such permitted sublicensee or subcontractor;
(ii) STADA secures all appropriate covenants, obligations and rights from any such permitted sublicensee or subcontractor to ensure that it will comply with all of STADA’s covenants and obligations to ALVOTECH under this Agreement to the extent that the sublicensee or subcontractor performs such covenants and obligations (including without limitation Article 12);
(iii) any rights licensed by a Third Party and sublicensed hereunder shall be subject to the terms and conditions of such Third Party agreement; and
(iv) with respect to the manufacturing rights granted under Article 2.1(a), (b) or (c), STADA may only engage any Third Party toll manufacturer in the ordinary and usual course of STADA’s business.
2.2 Subject to all other applicable terms and conditions of this Agreement, and provided STADA is not in an uncured material breach of this Agreement and/or the Supply Agreement, STADA’s rights under Article 2.1 with respect to the Products in the Territory shall at all times be:
(a) in the case of any manufacturing related rights, non-exclusive; and
(b) in the case of using, marketing, promoting, selling, offering, importing, and/or distributing the Products:
(i) Semi-Exclusive Rights during the Exclusivity Period in the Semi-Exclusive Countries;
(ii) Exclusive Rights during the Exclusivity Period in all other countries of the Territory, and
(iii) non-exclusive in all countries of the Territory following the expiration or early termination of the Exclusivity Period.
2.3 The rights under Article 2.1 shall at all times be used (and only used) for the purpose of:
(a) obtaining and using one MA for the Product(s) per country of the Territory; and
(b) using, clinically testing and/or having clinically tested (as described in Article 4.4), marketing and/or having marketed, promoting or having promoted, selling and/or having sold, offering and/or having offered for sale, importing and/or having imported, and/or distributing and/or having distributed the Products under any trademarks of STADA and/or its Affiliates and/or its Distributors in the Territory; and
(c) manufacturing Products inside and/or outside the Territory solely for use in the Territory, [***] months prior to the expiry of the Exclusivity Period subject to prior notification to ALVOTECH.
2.4 STADA hereby grants to ALVOTECH:
(a) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, for:
(i) all purposes outside of the Territory; and
(ii) all purposes inside the Territory other than with respect to the Products;
(b) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, to Develop the Products inside and outside the Territory and carry out its obligations under this Agreement in the Territory in accordance with this Agreement, including submitting to EMA a CP for the Products in the Territory;
(c) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, the Product IP Licensed Rights, and the Manufacturing Product ex-Territory IP Rights to manufacture the Products, provided that:
(i) [***] months prior to the expiry of the Exclusivity Period, STADA shall, subject to prior notification to ALVOTECH, be entitled to manufacture validation batches of the Products inside or outside the Territory for the sole purpose of using such Products in the Territory after expiry of the Exclusivity Period; and
(ii) after expiry of the Exclusivity Period, STADA shall have the non-exclusive right to manufacture the Products inside or outside the Territory for the sole purpose of marketing, promoting, selling and distributing the Products in the Territory; and
(d) the perpetual, fully-paid up, royalty-free, Semi-Exclusive (ALVOTECH or [***] designated by it, but not more, in addition to STADA and its Affiliates or Distributors) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, and the Product IP Licensed Rights for using, marketing, promoting, selling, offering, importing, and/or distributing the Products in the Semi-Exclusive Countries.
(a) Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates and Third Parties working on their behalf, to so disclose, the invention, discovery, development or other making of any Created Product IP Rights by such Party or any of its Affiliates or Third Parties acting on their behalf. Each Party assigns, and shall cause its Affiliates and Third Parties acting on behalf of such Party and such Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Created Product IP Rights as is necessary to fully effect the joint ownership provided for in Article 2.1(a), including all rights of action and claims for damages and benefits arising due to past and present infringement of such rights.
(b) Alvotech assigns, and shall cause its Affiliates to so assign, one-half of its right, title and interest in and to any Product IP Owned Rights to STADA to effect the joint ownership provided for in Article 2.1(a). Each Party will cooperate with the other Party and its representatives to effectuate such joint ownership rights in and to the Product IP Owned Rights and Created Product IP Rights, including without limitation, executing any documents in connection therewith. For clarity, all IP Rights created by a Party other than Created Product IP Rights (which shall be jointly owned pursuant to Article 2.1(a)), shall be owned by the Party creating such IP Rights.
2.6 Subject to all other applicable terms and conditions of this Agreement, STADA will become the owner of all Marketing Authorisations obtained by direct application of STADA, its Affiliates or by applications on behalf of STADA or its Affiliates submitted by ALVOTECH or a regulatory consultant chosen by STADA or its Affiliates. For the avoidance of doubt, this will not apply to MAs which ALVOTECH, its Affiliates or their distributors or agents may apply for when exercising ALVOTECH’s rights in the Semi-Exclusive Countries. In case of sublicensing according to Article 2.1(d) above STADA shall be entitled to transfer a further copy of the Dossier to the respective sublicensee for the relevant country of the Territory.
2.7 STADA is entitled to use and retain the copy of the Dossier (including all variations) it receives pursuant to this Agreement in accordance with all rights granted under (and subject to all terms of) this Agreement and the Supply Agreement.
2.8 For the avoidance of doubt, and without prejudice to the licences to STADA as set out in Articles 2.1 through 2.3 and to ALVOTECH as set out in Article 2.4, it is acknowledged that, as between the Parties, ALVOTECH retains full ownership or rights of all and any Product IP Licensed Rights and Manufacturing Product ex-Territory IP Rights licensed to STADA under this Agreement, and use of any Product IP Licensed Rights or Manufacturing Product ex-Territory IP Rights are subject to the terms and conditions of the applicable Third Party agreement. Except where Product IP Owned Rights and Created Product IP Rights are exclusively and/ or Semi-Exclusively licensed to the other Party under this Agreement, each Party may exploit, license, or sublicense (through multiple tiers) Product IP Owned Rights and Created Product IP Rights without the consent of, or a duty of accounting to, the other Party.
Appears in 2 contracts
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.), Confidentiality Agreement (Alvotech Lux Holdings S.A.S.)
Grant of Rights Ownership. 2.1 Subject to the terms and conditions set forth in this Agreement, including without limitation, Article 2.2, Article 2.3, Article 2.4, Article 2.5, Article 16 and Article 17, ALVOTECH hereby grants to STADA:
(a) the right to own an equal and undivided joint ownership interest (with ALVOTECH or its applicable Affiliate(s)) in the Territory in and to (i) the Product IP Owned Rights and (ii) the Created Product IP Rights;
(b) the sub-licensable right (through multiple tiers) to the Product IP Licensed Rights;
(c) the right under Manufacturing Product ex-Territory IP Rights; and
(d) the right to sublicense or subcontract any or all of the rights granted in accordance with Article 2.1(a), (b) and (c) to any Distributors and/or any other Third Party in the Territory, provided further that:
(i) STADA remains liable at all times towards ALVOTECH for the performance and any act or omission of any such permitted sublicensee or subcontractor;
(ii) STADA secures all appropriate covenants, obligations and rights from any such permitted sublicensee or subcontractor to ensure that it will comply with all of STADA’s covenants and obligations to ALVOTECH under this Agreement to the extent that the sublicensee or subcontractor performs such covenants and obligations (including without limitation Article 12);
(iii) any rights licensed by a Third Party and sublicensed hereunder shall be subject to the terms and conditions of such Third Party agreement; and
(iv) with respect to the manufacturing rights granted under Article 2.1(a), (b) or (c), STADA may only engage any Third Party toll manufacturer in the ordinary and usual course of STADA’s business.
2.2 Subject to all other applicable terms and conditions of this Agreement, and provided STADA is not in an uncured material breach of this Agreement and/or the Supply Agreement, STADA’s rights under Article 2.1 with respect to the Products in the Territory shall at all times be:
(a) in the case of any manufacturing related rights, non-exclusive; and
(b) in the case of using, marketing, promoting, selling, offering, importing, and/or distributing the Products:
(i) Semi-Exclusive Rights during the Exclusivity Period in the Semi-Exclusive Countries;
(ii) Exclusive Rights during the Exclusivity Period in all other countries of the Territory, and
(iii) non-exclusive in all countries of the Territory following the expiration or early termination of the Exclusivity Period.
2.3 The rights under Article 2.1 shall at all times be used (and only used) for the purpose of:
(a) obtaining and using one MA for the Product(s) per country of the Territory; and
(b) using, clinically testing and/or having clinically tested (as described in Article 4.4), marketing and/or having marketed, promoting or having promoted, selling and/or having sold, offering and/or having offered for sale, importing and/or having imported, and/or distributing and/or having distributed the Products under any trademarks of STADA and/or its Affiliates and/or its Distributors in the Territory; and
(c) manufacturing Products inside and/or outside the Territory solely for use in the Territory, [***] months prior to the expiry of the Exclusivity Period subject to prior notification to ALVOTECH.
2.4 STADA hereby grants to ALVOTECH:
(a) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, for:
(i) all purposes outside of the Territory; and
(ii) all purposes inside the Territory other than with respect to the Products;
(b) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, to Develop the Products inside and outside the Territory and carry out its obligations under this Agreement in the Territory in accordance with this Agreement, including submitting to EMA a CP for the Products in the Territory;
(c) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, the Product IP Licensed Rights, and the Manufacturing Product ex-Territory IP Rights to manufacture the Products, provided that:
(i) [***] months prior to the expiry of the Exclusivity Period, STADA shall, subject to prior notification to ALVOTECH, be entitled to manufacture validation batches of the Products inside or outside the Territory for the sole purpose of using such Products in the Territory after expiry of the Exclusivity Period; and
(ii) after expiry of the Exclusivity Period, STADA shall have the non-exclusive right to manufacture the Products inside or outside the Territory for the sole purpose of marketing, promoting, selling and distributing the Products in the Territory; and
(d) the perpetual, fully-paid up, royalty-free, Semi-Exclusive (ALVOTECH or [***] designated by it, but not more, in addition to STADA and its Affiliates or Distributors) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, and the Product IP Licensed Rights for using, marketing, promoting, selling, offering, importing, and/or distributing the Products in the Semi-Exclusive Countries.
(a) Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates and Third Parties working on their behalf, to so disclose, the invention, discovery, development or other making of any Created Product IP Rights by such Party or any of its Affiliates or Third Parties acting on their behalf. Each Party assigns, and shall cause its Affiliates and Third Parties acting on behalf of such Party and such Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Created Product IP Rights as is necessary to fully effect the joint ownership provided for in Article 2.1(a), including all rights of action and claims for damages and benefits arising due to past and present infringement of such rights.
(b) Alvotech assigns, and shall cause its Affiliates to so assign, one-half of its right, title and interest in and to any Product IP Owned Rights to STADA to effect the joint ownership provided for in Article 2.1(a). Each Party will cooperate with the other Party and its representatives to effectuate such joint ownership rights in and to the Product IP Owned Rights and Created Product IP Rights, including without limitation, executing any documents in connection therewith. For clarity, all IP Rights created by a Party other than Created Product IP Rights (which shall be jointly owned pursuant to Article 2.1(a)), shall be owned by the Party creating such IP Rights.
2.6 Subject to all other applicable terms and conditions of this Agreement, STADA will become the owner of all Marketing Authorisations obtained by direct application of STADA, its Affiliates or by applications on behalf of STADA or its Affiliates submitted by ALVOTECH or a regulatory consultant chosen by STADA or its Affiliates. For the avoidance of doubt, this will not apply to MAs which ALVOTECH, its Affiliates or their distributors or agents may apply for when exercising ALVOTECH’s rights in the Semi-Exclusive Countries. In case of sublicensing according to Article 2.1(d) above 2.1(d)above STADA shall be entitled to transfer a further copy of the Dossier to the respective sublicensee for the relevant country of the Territory.
2.7 STADA is entitled to use and retain the copy of the Dossier (including all variations) it receives pursuant to this Agreement in accordance with all rights granted under (and subject to all terms of) this Agreement and the Supply Agreement.
2.8 For the avoidance of doubt, and without prejudice to the licences to STADA as set out in Articles 2.1 through 2.3 and to ALVOTECH as set out in Article 2.4, it is acknowledged that, as between the Parties, ALVOTECH retains full ownership or rights of all and any Product IP Licensed Rights and Manufacturing Product ex-Territory IP Rights licensed to STADA under this Agreement, and use of any Product IP Licensed Rights or Manufacturing Product ex-Territory IP Rights are subject to the terms and conditions of the applicable Third Party agreement. Except where Product IP Owned Rights and Created Product IP Rights are exclusively and/ or Semi-Exclusively licensed to the other Party under this Agreement, each Party may exploit, license, or sublicense (through multiple tiers) Product IP Owned Rights and Created Product IP Rights without the consent of, or a duty of accounting to, the other Party.
Appears in 1 contract
Samples: Confidential Agreement (Alvotech Lux Holdings S.A.S.)
Grant of Rights Ownership. 2.1 Subject to the terms and conditions set forth in this Agreement, including without limitation, Article 2.2, Article 2.3, Article 2.4, Article 2.5, Article 16 14 and Article 1715, ALVOTECH hereby grants to STADA:
(a) the right to own an equal and undivided joint ownership interest (with ALVOTECH or its applicable Affiliate(s)) in the Territory in and to (i) the Product IP Owned Rights and (ii) the Created Product IP Rights;
(b) the sub-licensable right (through multiple tiers) to the Product IP Licensed Rights;
(c) the right under Manufacturing Product ex-Territory IP Rights; and
(d) the right to sublicense or subcontract any or all of the rights granted in accordance with Article 2.1(a), (b) and (c) to any Distributors and/or any other Third Party in the Territory, provided further that:
(i) STADA remains liable at all times towards ALVOTECH for the performance and any act or omission of any such permitted sublicensee or subcontractor;
(ii) STADA secures all appropriate covenants, obligations and rights from any such permitted sublicensee or subcontractor to ensure that it will comply with all of STADA’s covenants and obligations to ALVOTECH under this Agreement to the extent that the sublicensee or subcontractor performs such covenants and obligations (including without limitation Article 1210);
(iii) any rights licensed by a Third Party and sublicensed hereunder shall be subject to the terms and conditions of such Third Party agreement; and
(iv) with respect to the manufacturing rights granted under Article 2.1(a), (b) or (c), STADA may only engage any Third Party toll manufacturer in the ordinary and usual course of STADA’s business.
2.2 Subject to all other applicable terms and conditions of this Agreement, and provided STADA is not in an uncured material breach of this Agreement and/or the Supply Agreement, STADA’s rights under Article 2.1 with respect to the Products in the Territory shall at all times be:
(a) in the case of any manufacturing related rights, non-exclusive; and
(b) in the case of using, marketing, promoting, selling, offering, importing, and/or distributing the Products:
(i) Semi-Exclusive Rights during the Exclusivity Period in the Semi-Exclusive Countries;,
(ii) Exclusive Rights during the Exclusivity Period in all other countries of the Territory, and
(iii) non-exclusive in all countries of the Territory following the expiration or early termination of the Exclusivity Period.
2.3 The rights under Article 2.1 shall at all times be used (and only used) for the purpose of:
(a) obtaining and using one MA for the Product(s) per country of the Territory; and
(b) using, clinically testing and/or having clinically tested (as described in Article 4.43.4), marketing and/or having marketed, promoting or having promoted, selling and/or having sold, offering and/or having offered for sale, importing and/or having imported, and/or distributing and/or having distributed the Products under any trademarks of STADA and/or its Affiliates and/or its Distributors in the Territory; and
(c) manufacturing Products inside and/or outside the Territory solely for use in the Territory, [***] months prior to the expiry of the Exclusivity Period subject to prior notification to ALVOTECH.
2.4 STADA hereby grants to ALVOTECH:
(a) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, for:
(i) all purposes outside of the Territory; and
(ii) all purposes inside the Territory other than with respect to the Products;
(b) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights and the Created Product IP Rights, to Develop the Products inside and outside the Territory and carry out its obligations under this Agreement in the Territory in accordance with this Agreement, including submitting to EMA a CP for the Products in the Territory;
(c) the perpetual, fully-paid up, royalty-free, exclusive (even as to STADA and its Affiliates) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, the Product IP Licensed Rights, and the Manufacturing Product ex-Territory IP Rights to manufacture the Products, provided that:
(i) [***] months prior to the expiry of the Exclusivity Period, STADA shall, subject to prior notification to ALVOTECH, be entitled to manufacture validation batches of the Products inside or outside the Territory for the sole purpose of using such Products in the Territory after expiry of the Exclusivity Period; and
(ii) after expiry of the Exclusivity Period, STADA shall have the non-exclusive right to manufacture the Products inside or outside the Territory for the sole purpose of marketing, promoting, selling and distributing the Products in the Territory; and
(d) the perpetual, fully-paid up, royalty-free, Semi-Exclusive (ALVOTECH or [***] designated by it, but not more, in addition to STADA and its Affiliates or Distributors) and sub-licensable right (through multiple tiers) to freely exploit the Product IP Owned Rights, the Created Product IP Rights, and the Product IP Licensed Rights for using, marketing, promoting, selling, offering, importing, and/or distributing the Products in the Semi-Exclusive Countries.
(a) Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates and Third Parties working on their behalf, to so disclose, the invention, discovery, development or other making of any Created Product IP Rights by such Party or any of its Affiliates or Third Parties acting on their behalf. Each Party assigns, and shall cause its Affiliates and Third Parties acting on behalf of such Party and such Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Created Product IP Rights as is necessary to fully effect the joint ownership provided for in Article 2.1(a), including all rights of action and claims for damages and benefits arising due to past and present infringement of such rights.
(b) Alvotech assigns, and shall cause its Affiliates to so assign, one-half of its right, title and interest in and to any Product IP Owned Rights to STADA to effect the joint ownership provided for in Article 2.1(a). Each Party will cooperate with the other Party and its representatives to effectuate such joint ownership rights in and to the Product IP Owned Rights and Created Product IP Rights, including without limitation, executing any documents in connection therewith. For clarity, all IP Rights created by a Party other than Created Product IP Rights (which shall be jointly owned pursuant to Article 2.1(a)), shall be owned by the Party creating such IP Rights.
2.6 Subject to all other applicable terms and conditions of this Agreement, STADA will become the owner of all Marketing Authorisations obtained by direct application of STADA, its Affiliates or by applications on behalf of STADA or its Affiliates submitted by ALVOTECH or a regulatory consultant chosen by STADA or its Affiliates. For the avoidance of doubt, this will not apply to MAs which ALVOTECH, its Affiliates or their distributors or agents may apply for when exercising ALVOTECH’s rights in the Semi-Exclusive Countries. In case of sublicensing according to Article 2.1(d) above above, STADA shall be entitled to transfer a further copy of the Dossier to the respective sublicensee for the relevant country of the Territory.
2.7 STADA is entitled to use and retain the copy of the Dossier (including all variations) it receives pursuant to this Agreement in accordance with all rights granted under (and subject to all terms of) this Agreement and the Supply Agreement.
2.8 For the avoidance of doubt, and without prejudice to the licences to STADA as set out in Articles 2.1 through 2.3 and to ALVOTECH Alvotech as set out in Article 2.4, it is acknowledged that, as between the Parties, ALVOTECH retains full ownership or rights of all and any Product IP Licensed Rights and Manufacturing Product ex-Territory IP Rights licensed to STADA under this Agreement, and use of any Product IP Licensed Rights or Manufacturing Product ex-Territory IP Rights are subject to the terms and conditions of the applicable Third Party agreement. Except where Product IP Owned Rights and Created Product IP Rights are exclusively and/ or Semi-Exclusively licensed to the other Party under this Agreement, each Party may exploit, license, or sublicense (through multiple tiers) Product IP Owned Rights and Created Product IP Rights without the consent of, or a duty of accounting to, the other Party.
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Samples: Confidentiality Agreement (Alvotech Lux Holdings S.A.S.)