| Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. |
Exhibit 10.3
Execution Version
AMENDMENT NO. 10 TO
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Amendment No. 10 to Development and Commercialization Agreement (this “Amendment No. 10”) is effective as of June 01, 2026, (the “Amendment No. 10 Effective Date”) and is entered into by and between SAMSUNG BIOEPIS CO., LTD.,a corporation organized and existing under the laws of the Republic of Korea with a place of business at 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea (hereinafter referred to as “Samsung”) and ORGANON LLC,a limited liability company organized and existing under the laws of the State of Delaware, USA, with a place of business at 30 Hudson Street, Jersey City, NJ 07302 (hereinafter referred to as “Organon”).
Samsung and Organon are hereinafter referred to jointly as the “Parties” and individually as a “Party”.
RECITALS
WHEREAS
(i) On February 18, 2013, Samsung and Merck Sharp & Dohme Corporation (“Merck”) executed the Development and Commercialization Agreement, as amended on July 21, 2014, July 11, 2017, October 1, 2017, September 1, 2018, October 15, 2018, December 19, 2018, May 15, 2020, May 22, 2026, and May 26, 2026 (“DCA” or“Agreement”), for the purpose of, among other things, granting Merck an exclusive license (even as to Samsung) to Commercialize any and all Compounds and Products in the Territory.
(ii) Pursuant to Amendment No. 7 to Development and Commercialization Agreement effective May 15, 2020, Merck assigned all of its rights and obligations under the DCA to Organon.
(iii) The Parties now wish to amend the DCA to grant to Organon the right to commercialize SB17 Product in Australia.
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
I.DEFINITIONS
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The Parties agree that capitalized terms used but not otherwise defined in this Amendment No. 10 shall have the meanings ascribed thereto in the DCA.
II.AMENDMENT
2.1Section 1.41 is deleted in its entirety and replaced with the following:
2.2“Product Criteria” shall mean the criteria with respect to Indications, Presentations, dosage strengths and timing for receipt of Marketing Authorization (or in the case of the [* * *], and timing for filing applications for Marketing Authorization), set forth with respect to each Product on Schedule 1.41, Schedule 1.41A and Schedule 1.41B.
2.3Section 1.42 is deleted in its entirety and replaced with the following:
“Region” shall mean each of (i) the European Union, as a whole, (ii) the USA and its territories and possessions, as a whole, and (iii) the remainder of the Territory excluding the European Union and the USA and its territories and possessions (collectively, the “ROW Region”). However, (a) for Bevacizumab/Avastin Biosimilar only, “Region” shall mean (1) United Kingdom, France, Italy, Germany and Spain, as a whole until [* * *], (2) the USA (including its territories and possessions), until [* * *], (3) Canada, until [* * *] and (4) the respective territories and possessions of United Kingdom, France, Italy, Germany, Spain and Canada that are set forth on Schedule 1.56D, until [* * *](with respect to territories and possessions of United Kingdom, France, Italy, Germany, and Spain) or until [* * *](with respect to territories and possessions of Canada), and (b) for SB17 Product only, “Region” shall mean Canada and Australia.
For purposes of this Agreement, “European Union” or “E.U.” means, collectively, (a) the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto, and (b) the United Kingdom.
2.4Section 1.53 is deleted in its entirety and replaced with the following:
2.5“Supply Price” of each unit of a Product in a particular Presentation supplied by Samsung to Organon for sale in a Region shall mean (i) with respect to Products other than SB17 Product, the Target Supply Price determined under the Supply Price
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True-up Mechanism for such Product in such Presentation in such Region and (ii) with respect to SB17 Product, the Actual Supply Price determined in accordance with Schedule 1.54A for Canada and in accordance with Schedule 1.54B for Australia.
2.6In Section 1.54, the following sentence is added at the end:
2.7For clarity, notwithstanding the foregoing, the Supply Price True-up Mechanism is not applicable to SB17 Product. With respect to SB17 Product, the Actual Supply Price will be determined in accordance with Schedule 1.54A for Canada and in accordance with Schedule 1.54B for Australia.
2.8Section 1.56.5 is deleted in its entirety and replaced by the following:
2.9 1.56.5 With respect to Ustekinumab/Stelara Biosimilar, Canada and Australia.
2.10Section 3.7.2 is deleted in its entirety and replaced with the following:
3.7.2. Trademarks for SB17 Product.
(a) The Trademarks for the SB17 Product are set forth on Schedule 3.7.2.
(b) Samsung shall own and upon registration maintain the Trademarks for the SB17 Product. Subject to Section 9.7 and Section 9.8, Samsung shall be responsible for filing, prosecuting, registering, maintaining, enforcing and protecting the Trademarks for the SB17 Product, at Samsung’s own expense. Organon recognizes that the Trademarks for the SB17 Product are trademarks of Samsung and that Organon has no right or interest in the Trademarks for the SB17 Product other than those rights explicitly granted in this Agreement. Samsung will inform Organon of any action it may take with respect to the Trademarks for the SB17 Product to the extent such action may impact Organon’s rights, benefits and obligations hereunder. Samsung hereby grants to Organon an exclusive (even as to Samsung), non-transferable, royalty-free license to reproduce and use the Trademarks for the SB17 Product solely to Commercialize the SB17 Product in Canada and Australia during the applicable Term. Organon shall not contest or aid others in contesting the validity of the Trademarks for the SB17 Product or Samsung’s ownership of the Trademarks for the SB17 Product. Organon shall not apply for, or aid or cause others to apply for, any registration of the Trademarks for the SB17 Product or other trademarks similar to the Trademarks for the SB17 Product. Organon shall not take any other action
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inconsistent with Samsung’s ownership of the Trademarks for the SB17 Product. Organon shall not use the Trademarks for the SB17 Product in any way that might prejudice their distinctiveness or validity in Canada and Australia. As between the Parties, any benefits (including, without limitation, goodwill) accruing from Organon’s use of the Trademarks for the SB17 Product shall automatically vest in Samsung. Organon shall furnish to Samsung a sample of each use of the Trademarks for the SB17 Product by Organon for Samsung’s approval prior to use, provided that any subsequent uses of the sample previously approved by Samsung are permitted without an additional approval. Organon shall cooperate with Samsung in facilitating inspection and quality control over Organon’s use of the Trademarks for the SB17 Product. Organon shall not use the Trademarks for the SB17 Product, except as permitted under this Agreement in Canada and Australia. Organon’s use of the Trademarks for the SB17 Product shall not tarnish, blur, or dilute the quality associated with the Trademarks for the SB17 Product or the associated goodwill in Canada or Australia. Organon shall not use any other trademarks that are confusingly similar to the Trademarks for the SB17 Product in Canada and Australia, as applicable. Organon shall ensure that its permitted Affiliates and sublicensees also comply with the requirements provided in this Section 3.7.2. For clarity, subject to Section 10.6.2, in the event this Agreement expires or terminates with respect to the SB17 Product in Canada or Australia, as applicable, the license to use the applicable Trademarks for the SB17 Product in Canada or Australia, as applicable, will terminate automatically.
(c) Samsung shall not use, or license any Third Party to use, any other Trademarks that are confusingly similar to the Trademarks for the SB17 Product in Canada or Australia.
2.11In Section 6.2, the final sentence is deleted in its entirety and replaced with the following:
2.12For Launch of the SB17 Product in Canada, Organon will order those quantities of SB17 set forth on Schedule 6.2. For Launch of the SB17 Product in Australia, Organon will order those quantities of SB17 set forth on Schedule 6.2A.
2.13In Section 6.11, the final sentence is deleted in its entirety and replaced with the following:
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2.14For the purposes of this Agreement, “delivery” of a Product to Organon shall be deemed to occur, and title and risk of loss with respect to the Product shall pass to Organon, upon delivery of the Product to such carrier [* * *]; provided that, notwithstanding the foregoing, the Parties agree that title with respect to SB17 shall pass to Organon in international waters.
2.15Section 6.15 is deleted in its entirety and replaced with the following:
2.16Responsibility for Losses. The Parties agree to allocate losses or damages to Products (other than SB17 Product) or destruction of Products (other than SB17 Product) due to expiration of the shelf-life as described in Schedule 6.15. If Samsung deems necessary and should Organon accept SB17 Product which is delivered with less shelf life than the required remaining shelf life pursuant to Section 6.5, the Parties agree to discuss in good faith the sharing of the Supply Price for any SB17 Product supplied with such lesser shelf life which cannot be sold in the Territory and Samsung shall credit such amount against the next purchase order. Notwithstanding the foregoing, if Samsung deems necessary and should Organon accept SB17 Product for the Launch quantities as per Schedule 6.2 or Schedule 6.2A, as applicable, which is delivered with less shelf life than the required remaining shelf life pursuant to Section 6.5, then Samsung shall reimburse Organon for the Supply Price paid by Organon to Samsung for all remaining quantities of such SB17 Product that are no longer accepted for purchase by wholesalers due to the remaining shelf life.
2.17Section 7.1 is deleted in its entirety and replaced with the following:
2.187.1 Booking of Revenue; Records; Payment of Supply Price. Organon shall book revenue for sales of the Products throughout the Territory. Organon shall maintain records, in sufficient detail for accounting purposes and for purposes of this Agreement (including, without limitation, the Supply Price True-up Mechanism and the Net Sales Share Mechanism) which shall fully and properly reflect all work done and results achieved in the Commercialization of the Compounds and Products by Organon. The Supply Price for each Product (other than SB17 Product) shall be set, and adjusted, on a Calendar Year basis in accordance with the Supply Price True-up Mechanism attached hereto as Schedule 1.54. The Supply Price for SB17 Product shall be set and adjusted in accordance with Schedule 1.54A for Canada and Schedule 1.54B for Australia (“Net Sales Share Mechanism”). Within the later of (i) [* * *] following the delivery of Product to a carrier designated by Organon and (ii) [* * *] following the delivery of the invoice for such Product to Organon, Organon shall pay Samsung the Supply Price for such Product.
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2.19The Parties agree to provide the following additional representations and warranties solely with respect to this Amendment No. 10 and for the SB17 Product.
2.19.1New Section 8.1B is added to the DCA as follows:
8.1B. Representations and Warranties Each Party. Solely with respect to this Amendment No. 10, and with respect to the SB17 Product, each of Samsung and Organon hereby represents and warrants to the other Party as of the Amendment No. 10 Effective Date:
(a)it has the full right, power and authority to enter into this Amendment No. 10 and to perform its obligations hereunder;
(b)this Amendment No. 10 has been duly authorized by all necessary corporate action on its part, has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms; and
(c)this Amendment No. 10 does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law, rule, regulation, judgment, decree or order of any court, governmental body or administrative or other agency having jurisdiction over it.
2.19.2New Section 8.2C is added to the DCA as follows:
2.19.38.2C. Samsung Representations and Warranties. Solely with respect to this Amendment No. 10 and with respect to the SB17 Product, Samsung hereby represents and warrants to Organon as of the Amendment No. 10 Effective Date that:
(a)it has the full right, power and authority to Develop the SB17 Product and to grant the licenses granted under Article 3;
(b)it has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Samsung Patent Rights or Samsung Know-How, in each case, related to the SB17 Product other than a non-exclusive, non-transferable, royalty-free, fully-paid-up license granted to CMOs under certain Samsung Patent Rights and
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Samsung Know-How for the purpose of enabling the CMOs to fulfill their contract manufacturing obligations thereunder;
(c)there are no claims, judgments or settlements against or owed by Samsung, and no pending or threatened claims or litigation against Samsung, relating to the Samsung Patent Rights or Samsung Know-How, in each case, related to the SB17 Product;
(d)there are no actions or lawsuits pending or to Samsung’s knowledge threatened, against Samsung, its Affiliates or its CMOs alleging infringement of a Third Party’s intellectual property rights based on the Commercialization of the SB17 Product in Australia or the Manufacture of the SB17 Product for Commercialization in Australia as contemplated by this Amendment No. 10 and, to the knowledge of Samsung as of the Amendment No. 10 Effective Date, the Commercialization of the SB17 Product in Australia and the Manufacture of the SB17 Product for Commercialization of the SB17 Product in Australia as contemplated by this Amendment No. 10, in each case, do not and will not infringe any intellectual property rights of any Third Party; and
(e)Samsung has disclosed to Organon all reasonably relevant information regarding the SB17 Product Licensed IP and the existence of any patent opinions relating thereto, which, in each case, Samsung actually possesses or knows as of the Amendment No. 10 Effective Date.
2.19.4New Section 8.2D is added to the DCA as follows:
8.2D. Additional Representations, Warranties and Covenants of Samsung. Samsung hereby represents, warrants and covenants, as applicable, to Organon that:
(a)it shall at all times during the Term retain (but only for so long as the intellectual property licenses granted to Organon under the Samsung Know-How, Samsung Patent Rights and Trademarks for the SB17 Product for the Development, Manufacturing and Commercialization of the SB17 Product remain in effect) the full right, power, and authority to Commercialize the SB17 Product in Australia and to
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Manufacture the SB17 Product and to grant and maintain in effect all of the licenses and sublicenses granted to Organon with respect to SB17 Product Licensed IP, provided that for clarity, the foregoing representation and warranty shall not be construed to be a representation or warranty as to non-infringement of a third party’s intellectual property rights. For further clarity, Samsung is the sole and exclusive legal and beneficial owner of, or otherwise has the full right, power, and authority to grant the rights and licenses granted under this Agreement with respect to, the SB17 Product Licensed IP;
(b)[* * *];
(c)[* * *];
(d)neither it nor any of its Affiliates or, to its knowledge as of the Amendment No. 10 Effective Date, any of its licensors has, as of the Amendment No. 10 Effective Date, assigned, transferred, conveyed or otherwise encumbered any right, title and interest in the SB17 Product Licensed IP, or will make or permit such an assignment, transfer, conveyance or encumbrance during the Term, in each case to the extent such assignment, transfer, conveyance or encumbrance would conflict with any of the terms of this Agreement;
(e)no Third Party or any individual, whether an employee, officer, consultant or other Person who participated in any respect in the invention or authorship of any SB17 Product Licensed IP owned by Samsung, or with respect to the SB17 Product Licensed IP licensed by Samsung, to Samsung’s knowledge as of the Amendment No. 10 Effective Date, has any right, claim, title or interest in or to such SB17 Product Licensed IP and the SB17 Product Licensed IP owned by Samsung, or the SB17 Product Licensed IP licensed by Samsung, to Samsung’s knowledge, is free and clear of any liens, encumbrances, security interests, licenses, or other restrictions which would conflict with any of the terms of this Agreement; and
(f)except as disclosed as of the Effective Date, each of the Trademarks for the SB17 Product is valid, subsisting, and enforceable in Australia
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and is not subject to any pending or threatened opposition, cancellation, invalidity, or similar proceedings.
2.19.5Section 8.2.9 is deleted in its entirety and replaced with the following:
EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN SECTION 8.1, THIS SECTION 8.2, SECTION 8.1A, SECTION 8.1B, SECTION 8.2A, SECTION 8.2B, SECTION 8.2C, SECTION 8.2D AND ELSEWHERE IN THIS AGREEMENT, NEITHER SAMSUNG NOR ANY OTHER PERSON ACTING ON BEHALF OF SAMSUNG MAKES ANY REPRESENTATION OR WARRANTY (INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS), EXPRESS OR IMPLIED, TO ORGANON.
2.20New Section 8.4B is added to the DCA as follows:
8.4B Additional Representations and Warranties of Organon. Solely with respect to Amendment No. 10 and the SB17 Product, Organon hereby represents and warrants to Samsung as of the Amendment No. 10 Effective Date that it has the full right, power and authority to Commercialize the SB17 Product in Australia and to grant the licenses granted under Article 3.
2.21Section 8.4.5 is deleted in its entirety and replaced with the following:
EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN SECTION 8.1, THIS SECTION 8.4, SECTION 8.1A, SECTION 8.2B, SECTION 8.4A, SECTION 8.4B AND ELSEWHERE IN THIS AGREEMENT, NEITHER ORGANON NOR ANY OTHER PERSON ACTING ON BEHALF OF ORGANON MAKES ANY REPRESENTATION OR WARRANTY (INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS), EXPRESS OR IMPLIED, TO SAMSUNG.
2.22Section 8.5(v) is deleted in its entirety and replaced with the following:
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2.23(v) any claim, demand, action, or proceeding by a Third Party alleging that Organon’s use of any of the SB17 Product Licensed IP or importation or Commercialization of the SB17 Product in accordance with this Agreement infringes, misappropriates, or otherwise violates any intellectual property or proprietary rights of such Third Party. For the sake of clarity, any Liability, penalty, fine, interest, responsibility or obligation for which Samsung is obligated to indemnify Organon under Section 8.5(iv) or (v), or Section 8.5.1 below shall not be subject to the damages cap in Section 8.8. In addition, notwithstanding Section 9.3(C) of the PDP Program Supply Agreement which requires Organon and Samsung to share [* * *] of all Cancellation Costs (as defined in the PDP Program Supply Agreement) incurred in connection with the cancellation of the Binding Forecasts (as defined in the PDP Program Supply Agreement), if the cancellation of the Binding Forecasts is due to termination of the PDP Program Supply Agreement based on the breach of the Technology Transfer Agreements by [* * *], then Organon shall have no obligation to pay any portion of the Cancellation Fee and Samsung shall indemnify and hold Organon harmless from any Liability that is based on such obligation to pay the Cancellation Fee.
2.24Section 9.7 is deleted in its entirety and replaced with the following:
9.7 Treatment of Patent Rights and Trademarks for SB17 Product.
Notwithstanding the foregoing Sections of this Article 9, the Parties agree that with respect to the Commercialization of the SB17 Product in Canada and Australia, including the Manufacture of the SB17 Product outside of Canada or Australia, as applicable, for Commercialization in Canada and Australia, as applicable, the following Sections 9.7 and 9.8 replace and supersede the foregoing Sections of this Article 9.
9.7.1 Patent Rights for SB17 Product. Samsung shall, at its own expense and discretion, use Commercially Reasonable Efforts to maintain Samsung Patent Rights for the SB17 Product owned by Samsung. Samsung shall consult with Organon and keep Organon reasonably informed of the status of such Samsung Patents for the SB17 Product and shall provide Organon with all material correspondence received from the Canada Intellectual Property Office (“CIPO”) or IP Australia in connection therewith. Samsung may abandon or cease prosecution or maintenance of any Samsung Patent Right for the SB17 Product in Canada or Australia (or any other jurisdiction) in its sole discretion, provided that, if Samsung determines to abandon or
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cease prosecution or maintenance of Samsung Patent Right for the SB17 Product in or for Canada or Australia, Samsung shall provide reasonable prior written notice to Organon of such intention to abandon (which notice shall, to the extent possible, be given no later than [* * *] prior to the final deadline for any action that must be taken with respect to any such Samsung Patent Right for the SB17 Product with respect to the relevant patent authority). In such case, upon Organon’s written election provided no later than [* * *] after such notice from Samsung, Organon may assume prosecution and maintenance of such Samsung Patent Right for the SB17 Product at Organon’s sole cost and expense in the name of Samsung. If Organon does not provide such election within [* * *] after such notice from Samsung, Samsung may, in its sole discretion, discontinue prosecution and maintenance of such Samsung Patent Right for the SB17 Product in such country.
9.7.2. Trademarks for SB17 Product. Samsung shall, at its own expense and discretion, prepare, file, prosecute and maintain the Trademarks for the SB17 Product. Samsung shall, and shall require its licensor to, consult with Organon and keep Organon reasonably informed of the status of such Trademarks for the SB17 Product and shall, provide Organon with all material correspondence received from the CIPO in connection therewith. Samsung may abandon or cease prosecution or maintenance of any Trademarks for the SB17 Product in Canada or Australia (or any other jurisdiction) in its sole discretion, provided that, if Samsung determines to abandon or cease prosecution or maintenance of any Trademarks for the SB17 Product in or for Canada or Australia, Samsung shall provide reasonable prior written notice to Organon of such intention to abandon (which notice shall, to the extent possible, be given no later than [* * *] prior to the final deadline for any action that must be taken with respect to any such Trademarks for the SB17 Product with respect to the relevant trademark authority). In such case, upon Organon’s written election provided no later than [* * *] after such notice from Samsung, Samsung shall assign the applicable Trademarks for the SB17 Product to Organon and Organon may assume prosecution and maintenance of such Trademarks for the SB17 Product at Organon’s sole cost and expense in the name of Organon. If Organon does not provide such election within [* * *] after such notice from Samsung, Samsung may, in its sole discretion, discontinue prosecution and maintenance of such Trademarks for the SB17 Product in such country.
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2.25Section 9.8 is deleted in its entirety and replaced with the following:
2.269.8 Infringement of Intellectual Property Rights relating to SB17 Product.Each Party will promptly inform the other Party of any actual, alleged, or suspected infringement of any Samsung Patent Rights owned by Samsung or Trademarks for the SB17 Product by a Third Party, as well as any actual, alleged or suspected claims by Third Parties of infringement of such Third Party’s intellectual property right by the Development, Manufacture or Commercialization of SB17 Product in or for Canada or Australia, of which it becomes aware.
(a)Administrative and litigation proceedings, including but not limited to infringement action, declaratory judgment action, inter partesreview, opposition proceeding, post grant review, interference, or other equivalent action (“Proceedings”) alleging infringement of or challenging (including any claims within the Samsung Patent Rights) SB17 Product Licensed IP relating to SB17 Product or its exploitation in Canada or Australia will be conducted and controlled by Samsung (or Samsung’s licensor), in Samsung’s (or Samsung’s licensor’s) sole discretion. Samsung (or Samsung’s licensor) will have sole control of such Proceedings, and Samsung shall keep Organon regularly informed of the progress of such Proceedings. Samsung (or Samsung’s licensor) will bear all costs of conducting such Proceedings, including any payment of Third Party costs or damages that may be agreed to or awarded by the Courts. If Organon’s and/or its Affiliate’s joinder is necessary for Samsung (or Samsung’s licensor) to establish standing in such Proceedings, Organon will, at the request of Samsung, join such Proceedings, cooperate and provide reasonable assistance in any such Proceedings, all at Samsung’s costs. If Samsung fails to bring a Proceeding with respect to any actual, alleged, or suspected infringement of any SB17 Product Licensed IP owned by Samsung within [* * *] (or such shorter period in the event of a relevant deadline) following notice of such actual, alleged, or suspected infringement (or such shorter period as required by a relevant deadline), Organon shall have the right, but not the obligation, to bring and control any such Proceeding. If Organon initiates such Proceeding, Organon shall keep Samsung regularly informed of the progress of such Proceedings. If Samsung’s and/or its Affiliate’s joinder is necessary for Organon to establish standing in such Proceedings, Samsung and/or its Affiliate will join, such Proceedings. If Organon commences such a Proceeding, Samsung will, at the request of Organon, cooperate and provide reasonable assistance in any such Proceedings at its own cost. If such Proceedings are the subject of a settlement, the controlling Party will consider the
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non-controlling Party’s suggestions in good faith. All costs of any Proceeding commenced or defended solely by the controlling party will be borne by the controlling Party. Any recovery or damages derived or realized as a result of any Proceeding will be retained by the controlling Party.
(b)Proceedings involving any claim by a Third Party for infringement of such Third Party’s Patent Rights, know-how, trade secrets, trademarks or other intellectual property rights, by the Manufacture, use, import, export, offer for sale, or sale of the SB17 Product in Canada or Australia, or the Manufacture, use, import or export of the SB17 Product outside of Canada or Australia, as applicable, for purposes of Commercialization in Canada or Australia, as applicable, or any claim challenging or related to the use of the SB17 Product Licensed IP (but only to the extent such use is pursuant to any license and/or sublicense hereunder or as otherwise directed or authorized by Samsung in writing) will be conducted and controlled by Samsung (or Samsung’s licensor), including any settlement of such claims, using Commercially Reasonable Efforts, in Samsung’s (or Samsung’s licensor) sole discretion. Samsung (or Samsung’s licensor) will have sole control of such Proceedings, while keeping Organon regularly informed (including Samsung’s response to Organon’s request for a status update) of the progress of such Proceedings. If Organon’s and/or its Affiliate’s joinder is necessary for Samsung (or Samsung’s licensor) to establish standing in such Proceedings, Organon and/or its such Affiliate will join such Proceedings. Organon will, at the request of Samsung, cooperate and provide reasonable assistance in any such Proceedings at Samsung’s costs. If such Proceedings are the subject of a settlement, Samsung will discuss with Organon in reasonable detail the proposed settlement terms (unless confidentiality obligations to a third party prohibits such disclosure) that could materially impact Commercialization of the SB17 Product in Canada or Australia, and consider Organon’s suggestions in good faith and will not agree to any settlement that could adversely impact Organon’s right to Commercialize SB17 Product in Canada or Australia. All costs of any Proceedings conducted and controlled solely by Samsung (or Samsung’s licensor), regardless of whether Organon assists or joins such Proceedings, and all royalties payable to any Third Party related to a settlement of, or Court order arising from, any such Proceeding will be borne by Samsung (or Samsung’s licensor); provided that Organon may elect to participate in any such Proceedings at its own expense and Samsung will not be obligated to bear any such expenses of Organon if it is not otherwise required or requested to join or assist as provided hereunder. Any recovery or
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damages derived or realized as a result of any Proceeding, except as otherwise provided in this Section 9.8, will be retained by Samsung (or Samsung’s licensor). Notwithstanding the foregoing or any other provision of this Agreement to the contrary, Samsung shall have no obligation to control, conduct, defend or pay for any damages, costs, fees, or expenses in connection with any Proceedings, or any claims involved in any Proceedings, arising from Organon’s use of the SB17 Product Licensed IP outside the scope of any license or sublicense hereunder or for which Samsung has otherwise authorized Organon in writing to use such SB17 Product Licensed IP.
(c)Proceedings involving any claim by a Third Party for infringement of such Third Party’s Patent Rights, know-how, trade secrets, trademarks or other intellectual property rights related to the use of the Other Brand Elements in Canada or Australia (but only to the extent such use is as directed or authorized by Organon in writing), including but not limited to Organon’s logos, Organon’s name on packaging, Organon’s campaigns (concepts and other elements such as: visuals, photos, graphs, fonts and tables), promotional and non-promotional messages and claims, will be conducted and controlled by Organon, including any settlement of such claims, in Organon’s sole discretion. Organon will have sole control of such Proceedings, while keeping Samsung regularly informed of the progress of such Proceedings. If Samsung’s and/or its Affiliate’s joinder is necessary for Organon to establish standing in such Proceedings, Samsung and/or its such Affiliate will join such Proceedings at Organon’s costs. Samsung will, at the request of Organon, cooperate and provide reasonable assistance in any such Proceedings at Organon’s costs. Organon will bear all costs of conducting Proceedings conducted and controlled solely by Organon, regardless of whether Samsung assists or joins such Proceedings, including payment of Third Party costs or damages agreed to or awarded by the Courts; provided that Samsung may elect to participate in any such Proceedings at its own expense and Organon will not be obligated to bear any such expenses of Samsung if it is not otherwise required or requested to join or assist as provided hereunder. Any recovery or damages derived or realized as a result of any Proceeding will be retained by Organon. Notwithstanding the foregoing or any other provision of this Agreement to the contrary, Organon shall have no obligation to control, conduct, defend or pay for any damages, costs, fees, or expenses in connection with any Proceedings, or any claims involved in any Proceedings, arising from Samsung’s use of Other Brand Elements outside the scope for which Organon has authorized Samsung in writing to use such Other Brand Elements.
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(d)For the purposes of this Section 9.8, “Other Brand Elements” shall mean any Trademarks in the Territory (a) that are Controlled by Organon or any of its Affiliates and (b) that are held for use (i.e., subject to a pending trademark application or a trademark registration in jurisdictions where use is not required to register) or are used to Develop, Manufacture, perform medical affairs, or Commercialize the Product in the Territory, but excluding Trademarks included within the SB17 Product Licensed IP.
(e)Notwithstanding any other provision in the DCA, including Sections 2.4, 9.3 and 10.3, if (i) the Commercialization of the SB17 Product in Canada or Australia is prevented or enjoined for a period of [* * *] or more by Proceedings challenging or responding to any claims with respect to a Third Party’s patent rights, including a settlement arising from such Proceedings, or (ii) any challenge, opposition, cancellation, infringement claim, or other legal or regulatory issue, including any Proceedings, which results in any settlement or any unfavorable court decision (whether it is unfavorable in whole or in part, or whether the decision is an interim or final decision, or could be subject to appeal), that prevents, hinders or delays Organon from being able to use the Trademarks for SB17 Product, then, in each case of (i) and (ii), Organon shall have the right to terminate this Agreement as it relates to SB17 Product in Canada or Australia, as applicable, upon providing [* * *] notice to Samsung of such termination.
(f)In the event of a conflict between this Section 9.8 and any other Section in Article 9 with respect to the SB17 Product, this Section 9.8 controls.
2.27Section 10.2A is deleted in its entirety and replaced with the following:
10.2A. Termination for Convenience. Organon shallhave the right to terminate this Agreement with respect to SB17 (a) in Canada at any time following the [* * *] of the Launch of SB17 in Canada and (b) in Australia at any time following the [* * *] of the Launch of SB17 in Australia, in each case of (a) and (b), upon providing [* * *] written notice of its decision to exercise such termination right with respect to SB17.
2.28Section 10.4 is deleted in its entirety and replaced with the following:
2.2910.4 Termination Due to Infringement Claim, or Newly Issued Third Party Patent. Organon shall have the right to terminate this Agreement with respect to a particular Product (other than SB17 Product) in a particular Region in accordance
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with the terms of Section 9.1 and have the right to terminate this Agreement with respect to SB17 Product in Australia and Canada, as applicable, in accordance with the terms of Section 9.8. Each Party shall have the right to terminate this Agreement with respect to a particular Product (other than SB17 Product) in a particular Region in accordance with the terms of Section 9.3
2.30Section 10.6.2(a) is deleted in its entirety and replaced with the following:
2.31(a) In the event that this Agreement is terminated by Organon under Section 10.2 or 10.3, Organon shall have the right, but not the obligation, to take delivery of the Product(s) to be supplied pursuant to the Remaining Binding Forecasts (collectively, the “Post-Termination Delivery Products”), in whole or in part (at Organon’s election), in accordance with the terms of this Agreement, and Samsung shall perform its obligations relating to such Remaining Binding Forecasts and Post-Termination Delivery Products accordingly; provided that, Organon shall be entitled to retain any Post-Termination Delivery Products of which Organon took delivery pursuant to this Section 10.6.2(a) and which have not been sold to a Third Party by [* * *] after the end of the last Calendar Quarter covered by the Remaining Binding Forecast for Primary-Packaged Presentations, without any accounting or payment obligations to Samsung other than the payment of the Supply Price for such Post-Termination Delivery Products (which Supply Price, and the Post-Termination Delivery Products for which such Supply Price is payable, shall be reflected and taken into account in determining (i) “Organon Profit” and “Samsung Profit” for the purpose of calculating “Profit Differential” for the Final True-up Period under Schedule 1.54 for Products other than SB17 Product and (ii) the Quarterly True-Up Amount under Schedule 1.54A and Schedule 1.54B for SB17 Product);
2.32Section 10.6.2(c) is deleted in its entirety and replaced with the following:
2.33(c) In the event that this Agreement is terminated by Samsung under Section 10.3, Samsung shall have the right, but not the obligation, to sell and deliver the Post-Termination Delivery Products, in whole or in part (at Samsung’s election), to Organon in accordance with the terms of this Agreement, and Organon shall perform its obligations relating to the Remaining Binding Forecasts and such Post-Termination Delivery Products accordingly; providedthat with respect to Products, Organon shall return to Samsung (as soon as reasonably practicable after the expiration of the [* * *] period referred to below) any Post-Termination Delivery Products of which Organon took delivery pursuant to this Section 10.6.2(c) and which have not been sold to a Third Party by [* * *] after the end of the last Calendar Quarter covered by the
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Remaining Binding Forecast for Primary-Packaged Presentations, and Samsung shall be entitled to retain such Post-Termination Delivery Products, as well as the Supply Price paid or payable therefor, without any accounting or payment obligations to Organon (it being understood and agreed that neither such Supply Price nor the Post-Termination Delivery Products for which such Supply Price is payable shall be reflected or taken into account in determining (i) “Organon Profit” or “Samsung Profit” for the purpose of calculating “Profit Differential” for the Final True-up Period under Schedule 1.54 for Products other than SB17 Product and (ii) the Quarterly True-Up Amount under Schedule 1.54A and Schedule 1.54B for SB17 Product);
2.34Section 10.6.4A is deleted in its entirety and replaced with the following:
2.35If Organon is unable to Launch SB17 Product in Canada or Australia, as applicable, and terminates this Agreement with respect to SB17 Product in Canada or Australia, as applicable, in accordance with Section 10.2 or Section 10.4, as applicable, Samsung shall reimburse Organon for the Supply Price paid for SB17 Product within [* * *] of the effective date of termination of this Agreement with respect to SB17 Product in Canada or Australia, as applicable.
2.36New Schedule 1.41B (Product Criteria) to the DCA is attached hereto.
2.37New Schedule 1.54B (Net Sales Share Mechanism for SB17 Product in Australia) to the DCA is attached hereto.
2.38Schedule 3.7.2 (Trademarks for SB17 Product) attached hereto replaces the existing Schedule 3.7.2 (Trademarks for SB17 Product) attached to the DCA.
III.MISCELLANEOUS
3.1In the event a Party is required to file a copy of this Amendment No. 10 with a Regulatory Authority or any other governmental authority or agency, (i) such Party shall redact commercially sensitive information from such copy to the extent permitted under applicable law and (ii) such Party shall provide the other Party with an advance draft of the redacted form of this Amendment No. 10 that the disclosing Party proposes to file, with not less than ten (10) Business Days for review, and shall incorporate the non-disclosing Party’s comments to the extent additional or other redactions requested by the non-disclosing Party are permitted, and may reasonably be
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afforded confidential treatment, under applicable law and such authority or agency’s then-current practice.
3.2Sections 11.4, 11.6, 11.7, 11.9, and 11.11 through 11.17 of the Agreement shall apply to this Amendment No. 10, mutatis mutandis.
3.3The Agreement, as amended by this Amendment No. 10, together with the Schedules to the Agreement and any other agreements executed by authorized representatives of the Parties that make reference to the Agreement, contains the entire understanding of the Parties with respect to the Compounds and Products. Any other express or implied agreements, understandings, negotiations, writings and commitments, either oral or written, with respect to the subject matter of the Agreement are superseded by the terms of the Agreement as amended by this Amendment No. 10.
[Signatures on the Following Page]
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IN WITNESS WHEREOF, the Parties, intending to be legally bound, have caused this Amendment No. 10 to be executed by their duly authorized representatives as of the Amendment No. 10 Effective Date.
ORGANON LLC SAMSUNG BIOEPIS CO., LTD.
By: /s/ Matthew Walsh By: /s/ Kwang Yong Ryu
Name: Mathew Walsh Name: Kwang Yong Ryu
Title: Chief Financial Officer (CFO) Title: VP, Business Development
Date: 6/02/2026 Date: 6/2/2026
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SCHEDULE 1.41B - PRODUCT CRITERIA
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Schedule 1.54B
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3.7.2
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Schedule 6.2A
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