Document:

EX-10.7

 Exhibit 10.7 

EXECUTION COPY 

AMENDMENT NO. 3 TO 

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

This Amendment No. 3 to Development and Commercialization Agreement (this “Amendment No. 3) is effective as of
October 1, 2017 (the “Amendment 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 Cheomdan-daero 107, Yeonsu-gu, Incheon, 21987, Republic of Korea (hereinafter referred to as
“Samsung”); and 
 MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of the
State of New Jersey, USA, with a place of business at One Merck Drive, Whitehouse Station, NJ 08889, USA (hereinafter referred to as “Merck”). 

Samsung and Merck are hereinafter referred to jointly as the “Parties” and individually as a “Party”. 

RECITALS 
 WHEREAS 

(i) On February 18, 2013, Samsung and Merck executed the Development and Commercialization Agreement, as amended on July 21, 2014 and July 11,
2017 (“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) The Parties have agreed to exclude the Republic of Korea from the Territory as of the Amendment Effective Date and to specify the rights and obligations
of the Parties with respect to the transition to Samsung of the Commercialization of the Compounds and Products in the Republic of Korea. For clarity, such agreement by Merck shall not be used in support or furtherance of any argument, claim or
contention that Merck has breached any of its obligations under the DCA with respect to the Commercialization of Products in Korea. 
 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 
 The Parties agree that
capitalized terms used but not otherwise defined in this Amendment No. 3 shall have the meanings ascribed thereto in the DCA. 
 II. AMENDMENT

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

“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, excluding, however, the Republic of Korea; 

	 	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 Republic of Korea and 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 Republic of Korea and the countries, territories and possessions set forth on Schedule 1.56C. 

III. MISCELLANEOUS 
  

	3.1	 In the event a Party is required to file a copy of this Amendment No. 3 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. 3 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, and 11.11 through 11.17 of the Agreement shall apply to this Amendment
No. 3, mutatis mutandis. 

  

	3.3	 The Agreement, as amended by this Amendment No. 3, 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. 3. 

 IN WITNESS WHEREOF, the Parties, intending to be legally bound, have caused this Amendment No. 3
to be executed by their duly authorized representatives as of the Amendment Date. 
  

 
  

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

	Name: Joseph B. Promo	 		 	Name: Christopher Hansung Ko
	Title: Assistant Treasurer	 		 	Title: Chief Executive Officer
			
	Date: October 6, 2017	 		 	Date: October 10, 2017EX-10.8

 Exhibit 10.8 

EXECUTION COPY 
 AMENDMENT NO. 4
TO 
 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

This Amendment No. 4 to Development and Commercialization Agreement (this “Amendment No. 4”) is effective as of
September 1, 2018 (the “Amendment 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 Cheomdan-daero 107, Yeonsu-gu, Incheon, 21987, Republic of Korea (hereinafter referred to as
“Samsung”); and 
 MERCK SHARP & DOHME CORP., a corporation organized and existing under the laws of the
State of New Jersey, USA, with a place of business at One Merck Drive, Whitehouse Station, NJ 08889, USA (hereinafter referred to as “Merck”). 

Samsung and Merck are hereinafter referred to jointly as the “Parties” and individually as a “Party.” 

RECITALS 
 WHEREAS 

 

	 	(i)	 On February 18, 2013, Samsung and Merck executed the Development and Commercialization Agreement, as
amended on July 21, 2014, July 11, 2017, and October 1, 2017 (“DCA or Agreement”), for the purpose of, among other things, granting Merck the sole responsibility for the Commercialization of Compounds and Products
throughout the Territory. 

  

	 	(ii)	 In exercising its Commercialization responsibility, on August 2, 2018, Merck was informed that it was
awarded the U.S. Department of Veterans Affairs National Contract (“National Contract”) for infliximab (Renflexis®), contract no. 36E79718D0033, pursuant to which Renflexis® will be placed on a one-year U.S. federal nation-wide contract with an effective date of September 1, 2018, with an option of four subsequent one-year renewal periods. 

  

	 	(iii)	 As a condition of being awarded the National Contract, certain Federal Acquisition Regulation
(“FAR”) clauses were incorporated by reference into the National Contract that, by their terms, must be made part of 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, the Parties agree as follows: 
 I. DEFINITIONS 

The Parties agree that capitalized terms used but not otherwise defined in this Amendment No. 4 shall have the meanings ascribed thereto
in the Agreement. 

 II. AMENDMENT 
  

	 	2.1	 Section 2.5 is hereby amended to add the following subsection: 

 

	 	2.5.5	 In recognition of Merck having been awarded the U.S. Department of Veterans Affairs National Contract for
infliximab (Renflexis®), contract no. 36E79718D0033, with an effective date of September 1, 2018, Samsung represents and warrants that it will comply with the Federal Acquisition
Regulations (“FARs”) listed in the attached Schedule 2, which are hereby incorporated into the Agreement. 

  

	 	2.2	 Section 2A.3 is hereby amended to add the following subsection: 

 

	 	2A.3.5	 In recognition of Merck having been awarded the U.S. Department of Veterans Affairs National Contract for
infliximab (Renflexis®), contract no. 36E79718D0033, with an effective date of September 1, 2018, Merck represents and warrants that it will comply with the Federal Acquisition
Regulations (“FARs”) listed in the attached Schedule 2, which are hereby incorporated into the Agreement. 

 III.
MISCELLANEOUS 
  

	 	3.1	 In the event a Party is required to file a copy of this Amendment No. 4 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. 4 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, and 11.11 through 11.17 of the Agreement shall apply to this Amendment
No. 4, mutatis mutandis. 

  

	 	3.3	 The Agreement, as amended by this Amendment No. 4, 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. 4. 

 

	 	3.4	 This Amendment No. 4 may be signed in any number of counterparts (including by facsimile or electronic
transmission), each of which shall be deemed an original, but all of which shall constitute one and the same instrument, it being understood and agreed that the Parties need not sign the same counterpart. 

 IN WITNESS WHEREOF, the Parties, intending to be legally bound, have caused this Amendment No. 4
to be executed by their duly authorized representatives as of the Amendment Date. 
  

									
	MERCK SHARP & DOHME CORP.	 		 	SAMSUNG BIOEPIS CO., LTD
					
	By:	 	 /s/ Michael Schwartz
	 		 	By:	 	 /s/ Klaus Falk

	Name:	 	Michael Schwartz	 		 	Name:	 	Klaus Falk
	Title:	 	Assistant Treasurer	 		 	Title:	 	Vice President
					
	Date:	 	August 27, 2018	 		 	Date:	 	August 30, 2018

 SCHEDULE 2 

The Federal Acquisition Regulation (“FAR”) clauses set forth below are incorporated by reference into the Agreement to which this
Schedule relates, with the force and effect as though set forth in full text herein. The full text of FAR clauses may be accessed electronically at http://www.acquisition.gov. The provisions included in this Schedule are required by
Merck’s National Contract with the U.S. Department of Veterans Affairs. 
  

			
	 FAR CLAUSE
	  	 TITLE

	52.203-13	  	Contractor Code of Business Ethics and Conduct (Oct 2015)
		
	52.203-19	  	Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)
		
	52.219-8	  	Utilization of Small Business Concerns (Nov 2016)
		
	52.222-50	  	Combating Trafficking in Persons (Mar 2015)

 Additional FAR-Related Clauses 

The following additional clauses, which reference applicable FARs, are included in the Agreement as set forth below: 

 

	1.	 Payments to Influence Certain Federal Transactions. Pursuant to FAR 52.203-11 and FAR 52.203-12, Samsung and Merck hereby certify to the best of their knowledge and belief that no Federal appropriated funds have been or will be paid to any
person influencing or attempting to influence an officer or employee of any U.S. agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress on its behalf in connection with the awarding of the National
Contract. 

  

	2.	 Reporting Executive Compensation and Award. If applicable, Samsung and Merck will each provide
the other Party with any information necessary to satisfy the obligations under FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016), including the information specified in FAR
52.204-10(d)(2) and the information set forth in FAR 52.204-10(d)(3). Any information provided pursuant to this provision will be publicly disclosed.

  

	3.	 Non-Discrimination and Other Labor Requirements. Samsung
and Merck will, if applicable, abide by the requirements of 41 C.F.R. §§ 60-1.4, 60-1.7, 60-1.35(c), 60-300.5(a), 60-741.5(a), and 29 C.F.R. part 471, Appendix A to Subpart A, as updated from time to time. Among other requirements, these regulations prohibit discrimination
against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity, or
national origin. Moreover, when applicable, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, disability, or veteran status. 

	4.	 U.S. Government Reporting. No confidentiality provision included in the Agreement may be
construed to prohibit or otherwise restrict Samsung or Merck from lawfully reporting waste, fraud, or abuse to a designated investigative or law enforcement representative of the federal department or agency authorized to receive such information
under the procurement. 

  

	5.	 No Support of Terrorism. Samsung and Merck acknowledge that U.S. executive orders and laws,
including but not limited to Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It
is the legal responsibility of Samsung and Merck to ensure compliance with these executive orders and laws. This clause must be included in all subcontracts under this Agreement.

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