Document:

EX-10.5

 
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 10.5 

EXECUTION COPY 

AMENDMENT NO. 1 
 TO

 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

This Amendment No. 1 to Development and Commercialization Agreement (this “Amendment”) is effective as of July 21, 2014 (the
“Amendment 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 (“Samsung”) and MERCK SHARP & DOHME CORP., a
corporation organized and existing under the laws of the State of New Jersey, USA (“Merck”). 
 RECITALS: 

WHEREAS, Samsung and Merck entered into a Development and Commercialization Agreement dated February 18, 2013 (the “Agreement”)
whereby Merck became Samsung’s commercialization partner with respect to certain Biosimilars being developed by Samsung, upon the terms and conditions set forth therein; and 

WHEREAS, Samsung and Merck now desire to amend the Agreement upon the terms and conditions set forth herein, in order to add another Biosimilar being
developed by Samsung to the Agreement. 
 NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the
receipt and sufficiency of which are hereby acknowledged, Samsung and Merck hereby agree as follows: 
 ARTICLE 1 DEFINITIONS 

Capitalized terms used but not otherwise defined in this Amendment shall have the meanings ascribed to them in the Agreement. 

ARTICLE 2 AMENDMENT OF THE AGREEMENT 
  

	2.1	 Article 1 of the Agreement is hereby amended as follows: 

 

	 	2.1.1	 Section 1.3A is hereby added to Article 1 as follows: 

 

	 	“1.3A	 “Amendment Date” shall mean July 21, 2014, the date on which Amendment No. 1
to this Agreement is entered into by the Parties and becomes effective.” 

  

	 	2.1.2	 Section 1.14 is hereby amended to read in its entirety as follows: 

 

	 	“1.14	 “Compound” shall mean any and all of the following, as well as such other Biosimilars as the
Parties mutually agree in writing to add to this Agreement: 

  

	 	1.14.1	 Adalimumab/Humira Biosimilar; 

 

	 	1.14.2	 Bevacizumab/Avastin Biosimilar; 

 

	 	1.14.3	 Cetuximab/Erbitux Biosimilar; 

 

	 	1.14.4	 Infliximab/Remicade Biosimilar; 

 

	 	1.14.5	 Trastuzumab/Herceptin Biosimilar; and 

 

	 	1.14.6	 Etanercept/Enbrel Biosimilar” 

 

	 	2.1.3	 New Section 1.28A is hereby added to Article 1 as follows: 

 

	 	1.28A	 “Major Markets” shall mean Australia, Canada, Republic of Korea and Turkey.”

  

	 	2.1.4	 Section 1.41 is hereby amended to read in its entirety as follows: 

 

	 	“1.41	 “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 [* * *], timing for filing applications for Marketing Authorization) set forth with respect to each Product on Schedule 1.41.” 

 

	 	2.1.5	 Section 1.56 is hereby amended to read in its entirety as follows: 

 

	 	“1.56	 “Territory” shall mean the following: 

 

	 	1.56.1	 With respect to (i) Bevacizumab/Avastin Biosimilar, (ii) Cetuximab/Erbitux Biosimilar and
(iii) Trastuzumab/Herceptin Biosimilar, all of the countries in the world, and their territories and possessions; 

  

	 	1.56.2	 With respect to (i) Adalimumab/Humira Biosimilar and (ii) Infliximab/Remicade Biosimilar, all
of the countries in the world, and their territories and possessions, excluding, however, the countries, territories and possessions set forth on Schedule 1.56A; provided that the countries, territories and possessions set forth on Schedule
1.56B shall be part of the Territory with respect to Adalimumab/Humira Biosimilar and Infliximab/Remicade Biosimilar commencing on July 1, 2014; and 

  

	 	1.56.3	 With respect to Etanercept/Enbrel Biosimilar, all of the countries in the world, and their territories
and possessions, excluding, however, the countries, territories and possessions set forth on Schedule 1.56C.” 

  

	2.2	 Article 2 of the Agreement is hereby amended by adding the following as a new Section 2.7:

  

	 	“2.7	 Right of First Negotiation. During the Term, if Samsung desires to enter into negotiations with a Third
Party to grant such Third Party any right to Commercialize the [* * *] in [* * *] and its territories and possessions (collectively, the “United States”), then, prior to entering into such negotiations, Samsung shall inform Merck in
writing (a “ROFN Notice”) and, within forty-five (45) days after receipt of such ROFN Notice, Merck shall notify Samsung in writing as to whether it wishes to add [* * *] to the Territory for the Etanercept/Enbrel Biosimilar
under this Agreement. If Merck gives Samsung written 

  
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notice within such 45-day period that it wishes to make [* * *] part of the Territory for the [* * *], the Parties shall enter into good-faith negotiations
to amend this Agreement with respect to the Territory for the [* * *], additional payments to be made by Merck to Samsung and other provisions reasonably related to the expansion of the Territory for [* * *]. If, in response to the ROFN Notice,
(i) Merck notifies Samsung that it does not wish to make [* * *] part of the Territory for the Etanercept/Enbrel Biosimilar or (ii) Merck does not respond in writing within the above 45-day period,
or if the Parties fail to agree on appropriate amendments to this Agreement pursuant to this Section 2.7 within ninety (90) days after delivery of Merck’s written notice indicating that it wishes to add [* * *] to the Territory for
the Etanercept/Enbrel Biosimilar, Samsung shall be free to negotiate and/or enter into any agreement related to the Commercialization of the [* * *] in [* * *] with a Third Party; provided that (a) in the event Merck exercises its right
of first negotiation pursuant to this Section 2.7 but the Parties fail to agree on appropriate amendments to this Agreement within the above 90-day period to add [* * *] to the Territory for the
Etanercept/Enbrel Biosimilar, Samsung shall not enter into any agreement with a Third Party for the Commercialization of the Etanercept/Enbrel Biosimilar in the United States on terms that, as a whole, are materially more favorable to such Third
Party than the terms last offered by Samsung to Merck during the negotiations described above; and (b) in the event Samsung does not enter into such an agreement with a Third Party within one (1) year after delivery of the ROFN Notice to
Merck, Samsung shall, prior to entering into negotiations with a Third Party for the grant of any right to Commercialize the Etanercept/Enbrel Biosimilar in [* * *] (following the expiration of such one-year
period), submit another ROFN Notice to and enter into good-faith negotiations with Merck regarding such Commercialization right in accordance with the above provisions of this Section 2.7.” 

 

	2.3	 Section 3.5 of the Agreement is hereby amended to read in its entirety as follows: 

 

	 	“3.5	 Development and Manufacture. 

 

	 	(a)	 Samsung shall have sole responsibility for the Development of Compounds and Products, the Manufacturing of
Compounds and Products, and all regulatory activities relating to the Development or Manufacturing of Compounds and Products, throughout the Territory. Samsung shall use Commercially Reasonable Efforts, at its own expense, to Develop and Manufacture
each Product. As reasonably requested by Samsung, Merck shall provide clinical and/or regulatory input to Samsung with respect to Compound(s) or Product(s). Throughout the Territory, Samsung shall be the holder of the Marketing Authorizations for
the Products; provided, however, that Merck shall be the holder of a Clone of Samsung’s Marketing Authorizations for the Products in the European Union (where applicable). 

 

	 	(b)	 Notwithstanding anything to the contrary herein, [* * *]. 

  
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	2.4	 Section 3.9 of the Agreement is hereby amended as follows: 

 

	 	2.4.1	 Section 3.9.1 is hereby amended to read in its entirety as follows: 

 

	 	“3.9.1	 As soon as reasonably practicable after the Effective Date, the Parties shall discuss and execute a
pharmacovigilance agreement (the “Pharmacovigilance Agreement”), which shall set forth the responsibilities of each Party with respect to pharmacovigilance matters relating to the Products (including the Etanercept/Enbrel Biosimilar
Product), and which shall be amended from time to time to properly reflect the status of the marketing and sale of the Products and the relevant pharmacovigilance regulations of each Region and/or country in the Territory.”

  

	 	2.4.2	 Solely with respect to the Etanercept/Enbrel Biosimilar Product, Sections 3.9.2 through 3.9.7 are hereby
amended to read in their entirety as follows: 

  

	 	“3.9.2	 Samsung shall establish and maintain all necessary pharmacovigilance requirements for the
Etanercept/Enbrel Biosimilar Product in full compliance with all applicable laws and requirements of the Regulatory Authorities in the Territory for the Etanercept/Enbrel Biosimilar Product. 

 

	 	3.9.3	 Throughout the Term, Merck shall notify Samsung via source documents within one (1) business day
but not longer than three (3) calendar days of receipt by Merck of all relevant safety data, including, without limitation, any adverse experience (which term, as used in this Agreement, shall have the meaning ascribed to it in the
Pharmacovigilance Agreement) which it obtains during or in connection with the performance of its obligations under this Agreement. 

  

	 	3.9.4	 Samsung’s responsibilities for the Etanercept/Enbrel Biosimilar Product shall also include:
(i) owning and holding the global safety database; (ii) performing ongoing safety signal detection; (iii) establishing and maintaining risk management plans, if applicable; (iv) producing post-marketing periodic safety update
reports as required by applicable laws and regulations; and (v) contacting Merck in the Territory, including prompt communication to Merck of a significant new safety signal with respect to the Etanercept/Enbrel Biosimilar Product.

  

	 	3.9.5	 Merck’s responsibilities for the Etanercept/Enbrel Biosimilar Product shall include:
(i) executing risk management plans established by Samsung in the Territory if required; (ii) executing safety signal communication activities to healthcare practitioners in the Territory if required; and (iii) providing reasonable
assistance to Samsung in providing data as needed for the production of post-marketing periodic safety update reports. 

  

	 	3.9.6	 Samsung and Merck shall have the right, upon reasonable (at least thirty (30) days) prior written
notice, to periodically audit each other’s relevant Etanercept/Enbrel Biosimilar Product-related pharmacovigilance activities to monitor compliance with the obligations as set forth in this Section 3.9. Each Party shall, within a
reasonable time, reply to the other Party’s request for such audit. Such audit shall be reasonable in scope and take place during normal business hours. Each Party shall not routinely request an audit more than once every two (2) years,
except where there is a reasonable basis for such Party to suspect that the other Party has failed or is failing to comply with its obligations under this Section 3.9.” 

  
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	2.5	 Section 5.2 of the Agreement is hereby amended to read in its entirety as follows: 

 

	 	“5.2	 Payment Schedule. Subject to the terms and conditions of this Agreement, Merck shall pay to Samsung the
following milestone license fees for each Product meeting the applicable Product Criteria (except the payments pursuant to Sections 5.2.1 and 5.2.2, each of which payments shall be made only once, and except for the Products expressly excluded in
Sections 5.2.3, 5.2.4, 5.2.5 and 5.2.6); provided, however, that (i) the payments pursuant to Sections 5.2.1, 5.2.2 and 5.2.3 shall be made regardless of whether any Product Criteria are met, (ii) the payment pursuant to
Section 5.2.4 shall be made regardless of whether the relevant Product meets the Required M.A. Timing in EU, and (iii) the payment pursuant to Section 5.2.5 shall be made regardless of whether the relevant Product meets the Required
M.A. Timing in USA: 

  

	 	5.2.1	 Within ten (10) Business Days after the Effective Date: [* * *]; 

 

	 	5.2.2	 Within ten (10) Business Days after the Amendment Date: [* * *]; 

 

	 	5.2.3	 Within thirty (30) calendar days after the first successful completion in the USA or EU of a Phase
I Clinical Trial of such Product (which term, when used in this Section 5.2.3, does not include [* * *]) that demonstrates the required similarity in pharmacokinetic profile of such Product to the approved reference product with respect to all
primary endpoint(s) accepted by the applicable Regulatory Authority, where “successful completion” referred to in this Section 5.2.3 shall mean the receipt by Samsung of written communication (including by facsimile or electronic
transmission) from the applicable Regulatory Authority, following a meeting between Samsung and such Regulatory Authority to review the results of such Phase I Clinical Trial, which written communication does not require or request that Samsung
either repeat its Phase I Clinical Trial of such Product or halt its clinical trials of such Product: [* * *]; 

  

	 	5.2.4	 Within thirty (30) calendar days after the receipt of the first Marketing Authorization from the
FDA for such Product (which term, when used in this Section 5.2.4, does not include [* * *]): [* * *]; provided that Merck may delay making this milestone payment until Samsung has supplied to Merck all quantities of such Product,
meeting all of the requirements set forth in Section 6.1, which (i) are required under the terms of Article 6 to be supplied to Merck prior to the date of receipt of such Marketing Authorization and (ii) may be supplied by Samsung to
Merck prior to the date of receipt of such Marketing Authorization without infringing any Third Party Patent Rights relating to the relevant reference product (provided that to the extent such Product was not supplied to Merck by the date of
receipt of such Marketing Authorization due to the existence of such Third Party Patent Rights, Samsung shall use Commercially Reasonable Efforts to supply to Merck as soon as practicable following the expiration of such Third Party Patent Rights
all quantities of such Product that were required under the terms of Article 6 to be supplied to Merck prior to the date of receipt of such Marketing Authorization); and 

 

	 	5.2.5	 Within thirty (30) calendar days after the receipt of the first Marketing Authorization from the
EMA for such Product (which term, when used in this Section 5.2.5, does not include [* * *]; provided that Merck may delay making this milestone payment until Samsung has supplied to Merck all quantities of such Product, meeting all of
the requirements set forth in Section 6.1, which (i) are required under the terms of Article 6 to be supplied to Merck prior to the date of receipt of such Marketing Authorization and (ii) may be supplied by Samsung to Merck prior to
the date of receipt of such Marketing Authorization without infringing any Third Party Patent Rights relating to the relevant reference product 

  
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(provided that to the extent such Product was not supplied to Merck by the date of receipt of such Marketing Authorization due to the existence of such Third Party Patent Rights, Samsung
shall use Commercially Reasonable Efforts to supply to Merck as soon as practicable following the expiration of such Third Party Patent Rights all quantities of such Product that were required under the terms of Article 6 to be supplied to Merck
prior to the date of receipt of such Marketing Authorization). 

  

	 	5.2.6	 Within thirty (30) calendar days after the receipt of Marketing Authorizations in any three (each,
a “MA Major Market Country”) of the four Major Markets for such Product (which term, when used in this Section 5.2.6, does not include [* * *]): [* * *]; provided that Merck may delay making this milestone payment until
Samsung has supplied to Merck all quantities of such Product, meeting all of the requirements set forth in Section 6.1, which, with respect to each MA Major Market Country, (i) are required under the terms of Article 6 to be supplied to
Merck for sale in such MA Major Market Country prior to the date of receipt of the Marketing Authorization in such MA Major Market Country and (ii) may be supplied by Samsung to Merck prior to the date of receipt of the Marketing Authorization
in such MA Major Market Country without infringing any Third Party Patent Rights relating to the relevant reference product (provided that to the extent such Product was not supplied to Merck by the date of receipt of the Marketing
Authorization in a MA Major Market Country due to the existence of such Third Party Patent Rights, Samsung shall use Commercially Reasonable Efforts to supply to Merck as soon as practicable following the expiration of such Third Party Patent Rights
all quantities of such Product that were required under the terms of Article 6 to be supplied to Merck for sale in such MA Major Market Country prior to the date of receipt of the Marketing Authorization in such MA Major Market Country).

 Each of the above milestone license fees (other than the amounts set forth in Sections 5.2.1 and 5.2.2) shall be
payable only once under this Agreement for each Compound upon the Product incorporating or containing such Compound first achieving the relevant milestone. No amounts shall be due under this Agreement for subsequent or repeated achievements of any
milestone by a Product incorporating or containing the same Compound for which the relevant milestone license fee has already been paid. Each of the milestone license fees due under this Section 5.2 shall be
non-refundable, regardless of whether and to what extent the Parties are successful in Developing, Manufacturing and Commercializing the applicable Compound or Product. 

In the event that a Product does not meet all of the applicable Product Criteria, Merck may, at its sole discretion, choose nonetheless to pay
the applicable milestone license fee. Such waiver by Merck of the requirement to meet all of the Product Criteria in connection with such milestone license fee shall not constitute a waiver of the requirement to meet all of the Product Criteria in
connection with a subsequent milestone license fee payable for such Product.” 
  

	2.6	 Section 6.3.3(a) of the Agreement is hereby amended by adding the following at the end thereof:

  

	 	“(xii)	 [* * *]; and 

  

	 	(xiii)	 [* * *].” 

  
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	2.7	 Section 10.2 of the Agreement is hereby amended to read in its entirety as follows: 

 

	 	“10.2	 Termination by Merck on
Product-by-Product and Region-by-Region Basis. Notwithstanding anything contained
herein to the contrary, (a) in the event that a particular Product (other than the Etanercept/Enbrel Biosimilar Product) fails to achieve all of the applicable Product Criteria in a particular Region (i.e., the USA (and its territories
and possessions) or the European Union) by the Required M.A. Timing in USA for such Product or the Required M.A. Timing in EU for such Product, as applicable, Merck shall have the right, at its sole discretion, to terminate this Agreement with
respect to such Product solely in such Region (and, at Merck’s sole discretion, also in the ROW Region); provided that Merck may exercise such right of termination at any time within thirty (30) days after the Required M.A. Timing
in USA for such Product or the Required M.A. Timing in EU for such Product, as applicable; provided further that if Merck does not exercise such right of termination within the foregoing thirty (30) day period for any reason,
(i) Merck shall be deemed to have waived its right of termination under this Section 10.2 based on or on account of such non-achievement and (ii) all of the applicable Product Criteria for such
Product shall be deemed to have been met and achieved in such Region (for all purposes of this Agreement, including Section 5.2) upon receipt of the first Marketing Authorization from the FDA for such Product or the first Marketing
Authorization from the EMA for such Product, as applicable; and (b) in the event that the Etanercept/Enbrel Biosimilar Product fails to achieve all of the applicable Product Criteria by the date on which Marketing Authorizations have been
received in any three of the four Major Markets, Merck shall have the right, at its sole discretion, to terminate this Agreement with respect to the Etanercept/Enbrel Biosimilar Product for the entire Territory (but not part of the Territory)
therefor; provided that Merck may exercise such right of termination at any time within thirty (30) days after the date on which Marketing Authorizations have been received in any three of the four Major Markets; provided
further that if Merck does not exercise such right of termination within the foregoing thirty (30) day period for any reason, (i) Merck shall be deemed to have waived its right of termination under this Section 10.2 based on or
on account of such non-achievement and (ii) all of the applicable Product Criteria for the Etanercept/Enbrel Biosimilar Product shall be deemed to have been met and achieved in the entire Territory
therefor (for all purposes of this Agreement, including Section 5.2) upon the expiration of such thirty (30) day period.” 

  

	2.8	 Schedule 1.41 to the Agreement is hereby amended to read in its entirety as set forth in Attachment A
hereto. 

  

	2.9	 Schedule 1.54 to the Agreement is hereby amended as follows: 

 

	 	2.9.1	 [* * *] 

  

	 	2.9.2	 [* * *]: 

  

	 	“(l)	 [* * *]; and 

  

	 	(m)	 [* * *].” 

  

	2.10	 Attachment B hereto is hereby added to the Agreement as a new Schedule 1.56C. 

 

	2.11	 Except as expressly amended by this Amendment, the Agreement shall remain in full force and effect in
accordance with its terms. 

  
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 ARTICLE 3 MISCELLANEOUS 
  

	3.1	 In the event a Party is required to file a copy of this Amendment with a Regulatory Authority or any other
governmental authority or agency, (i) such Party shall redact the list of Biosimilars (and references to all or part of them) set forth in Section 2.1.2 and other provisions of this Amendment and other 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 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 afforded confidential treatment, under applicable law and such authority or agency’s then-current practice. 

 

	3.2	 Sections 11.4, 11.5, 11.6, 11.7, 11.9, 11.11, 11.13, 11.14 and 11.17 of the Agreement shall apply to this
Amendment, mutatis mutandis. 

  

	3.3	 The Agreement, together with the Schedules thereto, as amended by this Amendment, 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. 

 [Signatures on the Following Page] 

  
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 IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Date. 

 

									
	SAMSUNG BIOEPIS CO., LTD.	 		 	MERCK SHARP & DOHME CORP.
					
	BY:	 	 /s/ Christopher Ko
	 		 	BY:	 	 /s/ Roger M. Perlmutter

	NAME: Christopher Ko	 		 	NAME: Roger M. Perlmutter, M.D., Ph.D.
	TITLE: Representative Director	 		 	TITLE: EVP and President, MRL

  
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 ATTACHMENT A 

SCHEDULE 1.41 
 [* * *]

  
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 ATTACHMENT B 

SCHEDULE 1.56C 
 [* * *]

  
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[* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.]EX-10.6

 
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 10.6 

AMENDMENT NO. 2 
 TO

 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

This Amendment No. 2 to Development and Commercialization Agreement (this “Amendment No. 2”) is effective as of Aug
2, 2017 (the “Amendment 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 (“Samsung”) and MERCK SHARP & DOHME
CORP., a corporation organized and existing under the laws of the State of New Jersey, USA (“Merck”). 
 RECITALS:

 WHEREAS, Samsung and Merck entered into a Development and Commercialization Agreement dated February 18, 2013 (the
“Agreement”) whereby Merck became Samsung’s commercialization partner with respect to certain Biosimilars being developed by Samsung, upon the terms and conditions set forth therein; 

WHEREAS, Samsung and Merck entered into an amendment dated July 21, 2014 to add another Biosimilar being developed by Samsung to the Agreement
(“Amendment No. 1”); and 
 WHEREAS, Samsung and Merck now desire to further amend the Agreement upon the terms
and conditions set forth herein, in order to (i) clarify risk sharing by the Parties with respect to Base Case Requirements and Upside Requirements (as those terms are defined below) of quantities of Products to be supplied by Samsung to Merck
and Products discarded due to insufficient shelf-life, (ii) change the true-up period from annual to quarterly for purposes of true-up calculation; and
(iii) expand the definition of Merck Costs; 
 NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained
herein, the receipt and sufficiency of which are hereby acknowledged, Samsung and Merck hereby agree as follows: 
 ARTICLE 1 DEFINITIONS 

Capitalized terms used but not otherwise defined in this Amendment No. 2 shall have the meanings ascribed to them in the Agreement or Amendment
No. 1. 
  

 ARTICLE 2 SECOND AMENDMENT OF THE AGREEMENT 

 

	2.1	 Article 1 of the Agreement is hereby amended as follows: 

 

	 	2.1.1	 Section 1.47a is hereby added to Article 1 as follows: 

1.47a “Base Case Requirements” means the Binding Forecast quantities of the Product, as determined by Merck, required by
Merck for distribution, marketing and sale of the Product in the Territory. 
  

	 	2.1.2	 Section 1.47b is hereby added to Article 1 as follows: 

1.47b “Strategic Stock” means additional quantities of the Product to be Manufactured by Samsung in response to the Upside
Requirements requested by Merck, as determined by the D&OP Team and confirmed by the JSC, based on Samsung’s ability to supply these requirements and associated costs of Manufacture and discard risks due to insufficient remaining shelf-life
of unsold Products. 
  

	 	2.1.3	 Section 1.47c is hereby added to Article 1 as follows: 

1.47c “Safety Stock” means additional quantities of the Product to be Manufactured by Samsung, as determined by the D&OP
Team and confirmed by the JSC, as extra stock for the mitigation of potential supply disruptions within the supply chain in order to be assured of meeting the Base Case Requirements of such Product. 

 

	 	2.1.4	 Section 1.47d is hereby added to Article 1 as follows: 

1.47d “Upside Requirements” means additional quantities of the Product beyond the Base Case Requirements requested by Merck
to be supplied by Samsung in order to meet additional demand due to significantly uncertain events, including but not limited to early regulatory approval, sudden increase in market demand such as winning a government tender, and earlier market
launch than expected due to earlier favorable outcome of patent litigation. 
  

	 	2.1.5	 Section 1.47e is hereby added to Article 1 as follows: 

1.47e “Remaining Inventory” means additional quantities of the Product, other than the Base Case Requirements, the Safety
Stock, and the Strategic Stock, which Samsung elects, in its sole discretion, to Manufacture. 
  

	2.2	 Article 6 of the Agreement is hereby amended as follows: 

 

	 	2.2.1	 Section 6.3.1 is hereby amended to read in its entirety as follows: 

 

	 	6.3.1	 Rolling Forecast and Discard Liability 

(A) No later than [* * *] days after submission of the first application for Marketing Authorization for any Product, Merck
shall provide Samsung with an initial forecast of Merck’s Base Case Requirements and any Upside Requirements of Products for Commercialization in the Territory for each of the succeeding [* * *] Calendar Quarters. Thereafter, on or before the
tenth (10th) day of January, April, July and October of each year during the Term, Merck shall provide Samsung with a rolling forecast of Merck’s Base Case Requirements and Upside Requirements of Products for Commercialization in the Territory
for each of the succeeding [* * *] Calendar Quarters (each such initial and subsequent forecast being referred to herein as a “Rolling Forecast”). 

  
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 (B) Merck’s forecasts of Upside Requirements will be communicated by
Merck in the Rolling Forecasts of the Product separately from the Base Case Requirements and will further include the underlying assumptions and estimated probability that the unanticipated event which justifies the additional quantities to be
Manufactured will occur, as well as the probability that Merck may be able to timely Commercialize all or some of the quantities included in the Upside Requirements. 

(C) Within [* * *] days following Samsung’s receipt of Merck’s quarterly Rolling Forecast, the D&OP Team shall
agree on (i) the quantity of Strategic Stock of the Products necessary to meet the Upside Requirements, and (ii) the quantity of Safety Stock of the Products required to mitigate supply interruptions of Base Case Requirements of such
Products. Final Strategic Stock and Safety Stock supply quantities will require mutual agreement by both Parties. 
 (D)
Within [* * *] days after the D&OP Team agrees on the Strategic Stock quantity and the Safety Stock quantity, the D&OP will submit to the JSC members by email, for concurrence by email, a written supply plan indicating the monthly supply
requirements to meet the Base Case Requirements, the Strategic Stock and the Safety Stock, and SB’s Remaining Inventory (if any) planned for production. 
  

	 	2.2.2	 Section 6.5.1 is hereby amended to read in its entirety as follows: 

6.5.1 If a Product is approved with a [* * *] or greater shelf life, Samsung shall be obligated to deliver the Product to Merck
within [* * *] of the completion of the final sterile filtration of such Product and with at least [* * *] of the approved shelf life remaining. Notwithstanding the foregoing, the Parties acknowledge that, due to processing, quality testing and/or
release timing requirements for the Product, Samsung may, on occasion, be unable to deliver the Product within such [* * *] period and/or with at least [* * *] of the approved shelf life remaining, despite the exercise of Commercially Reasonable
Efforts to do so; in such case, such inability shall not, standing alone, constitute a breach of this Agreement. Should Samsung have any inventory of Product that does not meet both of the above criteria, the D&OP Team shall review such
inventory, and Merck may, in its sole discretion, accept such Product after the [* * *] deadline and/or with less than [* * *] of the approved shelf life remaining, on a
case-by-case basis. If the Product is rejected by Merck due to insufficient shelf-life, Samsung may not incorporate in Samsung Costs any Operational Costs and other
costs associated with the resulting discarded Product. 

  
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[* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.] 

	 	2.2.3	 Section 6.5.2 is hereby amended to read in its entirety as follows: 

6.5.2 During any period when a Product is approved by the Regulatory Authorities to be labeled with a shelf life of less than
[* * *], Samsung shall use Commercially Reasonable Efforts to deliver the Product to Merck within [* * *] of the completion of the final sterile filtration of such Product. Notwithstanding the foregoing, the Parties acknowledge that, due to
processing, quality testing and/or release timing requirements for the Product, Samsung may, on occasion, be unable to deliver the Product within such [* * *] period despite the exercise of Commercially Reasonable Efforts to do so; in such case, a
failure to comply with the [* * *] deadline shall not, standing alone, constitute a breach of this Agreement. Merck and Samsung will discuss in good faith on a
case-by-case basis how best to address any Product with insufficient remaining shelf-life. 
  

	2.3	 New Section 6.15 is added as follows. 

6.15 Responsibility for Losses. The Parties agree to allocate losses or damage to Products or destruction of Products due to
expiration of the shelf-life as described in new Schedule 6.15 as set forth in Attachment B hereto. 
  

	2.4	 Schedule 1.54 of the Agreement is hereby amended to read in its entirety as set forth in Attachment A hereto.

 ARTICLE 3 MISCELLANEOUS 
  

	3.1	 In the event a Party is required to file a copy of this Amendment No. 2 with a Regulatory Authority or any
other governmental authority or agency, (i) such Party shall redact (A) the list of Biosimilars (and references to all or part of them) set forth in Section 2.1.2 and in other provisions of this Amendment No. 2 and (B) other
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. 2 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 afforded confidential treatment, under applicable law and such authority or agency’s then-current practice. 

 

	3.2	 Sections 11.4, 11.5, 11.6, 11.7, 11.9, 11.11, 11.13, 11.14, 11.15, 11.16 and 11.17 of the Agreement shall apply
to this Amendment No. 2, mutatis mutandis. 

  

	3.3	 The Schedules attached to this Amendment No. 2 are incorporated herein by reference and
shall be deemed a part of the Agreement, as amended by this Amendment No. 2. The Agreement, as amended by Amendment No. 1 and this Amendment No. 2, may be amended, or any term hereof modified,
only by a written instrument duly executed by authorized representative(s) of both Parties.[Signatures on the Following Page] 

  
 4 

[* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.] 

 IN WITNESS WHEREOF, the Parties have executed this Amendment No. 2 as of the Amendment Date.

  

									
	SAMSUNG BIOEPIS CO., LTD.	 		 	MERCK SHARP & DOHME CORP.
					
	BY:	 	 /s/ Christopher Ko
	 		 	BY:	 	 /s/ Joseph B. Promo

	NAME: Christopher Ko	 		 	NAME: Joseph B. Promo
	TITLE: Representative Director	 		 	TITLE: Assistant Treasurer

  
 5 

 ATTACHMENT A 

SCHEDULE 1.54 
 [* * *]

  
 6 

[* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.] 

 ATTACHMENT B 

SCHEDULE 6.15 
 [* * *]

  
 7 

[* * *]=[CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.]

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