Document:

EX-10.3

 Exhibit 10.3 

MERCK TO ORGANON TRANSITION SERVICES AGREEMENT 

This Transition Services Agreement (this “Agreement”), dated as of [____], 2021 (the “Effective Date”) is
entered into by and between Organon LLC, a Delaware limited liability company (“Organon”), and MSD International GmbH, a limited liability company organized under the laws of Switzerland (“Merck” and together with
Organon, each a “Party” and collectively, the “Parties”). 
 RECITALS 

WHEREAS, Merck & Co., Inc. (“Merck Parent”), an Affiliate of Merck, has announced that it will be entering into a
separation transaction (the “Separation”, and the separation and distribution agreement pursuant to which the Separation will be effected, the “Separation and Distribution Agreement”, and the date of consummation of
the Separation, the “Separation Date”) pursuant to which, among other things, Merck Parent will transfer to Organon & Co., a Delaware corporation, an Affiliate of Organon (“Organon Parent”), the business of
developing, manufacturing, commercializing, distributing and selling Organon Products and ancillary and related operations with respect to the Organon Business; and 

WHEREAS, in connection with the Separation, Merck and Organon desire to enter into this Agreement pursuant to which Merck will provide certain
transitional services to Organon on the terms, and subject to the conditions, set forth herein. 
 NOW, THEREFORE, for good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereby agree as follows: 

1. Definitions. For the purpose of this Agreement, the following capitalized terms have the meaning set forth in this
Section 1. Capitalized terms used but not defined herein shall have the meaning given to them in the applicable Transaction Document. 

1.1 “Additional Services” has the meaning set forth in Section 2.2.1(i). 

1.2 “Ad Hoc Services” has the meaning set forth in Section 2.2.2(i). 

1.3 “Affiliate” means any Person which, directly or indirectly through one or more intermediaries, controls, is controlled by
or is under common control with a Party, for so long as such Person controls, is controlled by or is under common control with a Party, and regardless of whether such Affiliate is or becomes an Affiliate on or after the Effective Date. For purposes
of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (i) direct or indirect ownership of
more than fifty percent (50%) of the voting securities or other voting interest of any Person (including attribution from related parties), or (ii) the possession, directly or indirectly, of the power to direct or cause the direction of the
management and policies of such Person, whether through ownership of voting securities, by contract, as a general partner, as a 

 manager, or otherwise. Notwithstanding the foregoing, the Parties agree that from and after the Separation
Date, neither Organon Parent nor any Organon Subsidiary shall be deemed to be an Affiliate of Merck Parent or any Merck Subsidiary and neither Merck Parent nor any Merck Subsidiary shall be deemed to be an Affiliate of Organon Parent or any Organon
Subsidiary. 
 1.4 “Agreement” has the meaning set forth in the Preamble. 

1.5 “Applicable Law” means applicable laws, rules, regulations, guidelines or other requirements of a Governmental Authority
that may be in effect from time to time. 
 1.6 “Calendar Month” means a period commencing at the beginning of a day of one
of the twelve (12) months of the year and ending immediately before the beginning of the corresponding day of the next month, provided, however, that (i) the first Calendar Month of this Agreement shall commence on the Effective Date and
end on the last day of the Calendar Month in which the Effective Date occurs and (ii) the last Calendar Month of this Agreement shall commence on the commencement of such Calendar Month and end on the date of expiration or termination of this
Agreement. 
 1.7 “Calendar Quarter” means each period of three (3) consecutive calendar months ending March 31,
June 30, September 30, and December 31; provided, however, that (i) the first Calendar Quarter of this Agreement shall commence on the Effective Date and end on the last day of the Calendar Quarter in which the Effective Date occurs
and (ii) the last Calendar Quarter of this Agreement shall commence on the commencement of such Calendar Quarter and end on the date of expiration or termination of this Agreement. 

1.8 “Calendar Year” means each period during the Term commencing on January 1 and ending on December 31 of such
calendar year; provided, however, that (i) the first Calendar Year of this Agreement shall commence on the Effective Date and end on December 31 of the same calendar year and (ii) the last Calendar Year of this Agreement shall
commence on January 1 of the calendar year in which this Agreement terminates or expires and end on the date of expiration or termination of this Agreement. 

1.9 “Commercially Reasonable Efforts” means with respect to the efforts to be expended by a Party with respect to any
objective, the reasonable, diligent, good faith efforts to accomplish such objective as a reasonable global pharmaceutical company would normally use to accomplish a similar objective under similar circumstances, it being understood that, unless
otherwise set forth in the Transition Services Schedule or elsewhere in this Agreement, as related to the performance of Services, as applicable, Merck’s level of efforts shall be measured against and be no greater than and shall be in
accordance with the efforts expended by Merck to accomplish such particular Service as Merck used during the twelve (12) month period prior to the commencement of such Service. 

1.10 “Confidential Information” means all confidential information and data relating to a Party (including information
regarding such Party’s and its Affiliates’ business, employees, development plans, programs, documentation, techniques, trade secrets, systems, and know-how) disclosed or provided by or on behalf of
such Party to the other Party pursuant to, or in connection with, this Agreement. “Confidential Information” does not include any information 

  
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 or data: (i) rightfully previously known by a Party hereto, or acquired from a Third Party without a
continuing restriction on use (for clarity, excluding any such information or data possessed by Merck (or its Affiliate) prior to the Separation and assigned to Organon as part of the Separation, which shall be considered Confidential Information of
Organon for purposes of this clause (i), as applicable); (ii) which is or becomes publicly known without breach of this Agreement; or (iii) which is independently developed without violating any obligations under this Agreement and without
reference to the Confidential Information of the other Party. Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public
or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party. 

1.11 “Covered Personal Data” has the meaning set forth in Section 7.5.1. 

1.12 “Cutover Plan” has the meaning set forth in the applicable Interim Operating Agreement or NEB Settlement Agreement for
Deferred Markets. 
 1.13 “Data Protection Law” has the meaning set forth in Section 7.5.1. 

1.14 “Data Subject” has the meaning set forth in Section 7.5.1. 

1.15 “Deferred Market” has the meaning set forth in the Separation and Distribution Agreement. 

1.16 “De Minimis Services” has the meaning set forth in Section 2.2.4. 

1.17 “Dependent Service Element” has the meaning set forth in Section 2.8.2(i). 

1.18 “Discards” means, with respect to any Organon Product (including any Samples (as defined in the Regulatory Agreement)),
any and all discards (including write-offs) of such Organon Product that may arise as a result of, or otherwise in connection with the performance of activities by any Party under this Agreement or the Regulatory Agreement including any discards
that arise as a result of expiration or otherwise. For the avoidance of doubt, “Discards” shall not include any discards to the extent expressly provided for pursuant to any supply, manufacturing or similar agreement between the Parties
and/or their respective Affiliates. 
 1.19 “Dollars or $” means the lawful currency of the United States. 

1.20 “Effective Date” has the meaning set forth in the Preamble. 

1.21 “Exit Date” has the meaning set forth in the applicable Interim Operating Agreement or NEB Settlement Agreement for
Deferred Markets. 
 1.22 “Expense” has the meaning set forth in Section 3.2.1. 

1.23 “Expense Activity” means any activity, support or work provided by Merck pursuant to Section 3.2. 

  
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 1.24 “Force Majeure Event” has the meaning set forth in Section 12.2.

 1.25 “Governmental Authority” means any United States (federal, state or local), or any other foreign, government or
political subdivision thereof, or any multinational governmental organization or authority, or any authority, agency or commission, in each case, entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing
authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body. 

1.26 “Grace Period” means, with respect to each Organon Product, the six (6) month period following the Marketing
Authorization Transfer Date (as defined in the Regulatory Agreement). 
 1.27 “Industry Code” means those codes adopted by
industry associations which govern Merck’s business as of the Effective Date, including PhRMA, IFPMA, and corresponding national codes of other countries. 

1.28 “Information” means information in written, oral, electronic or other tangible or intangible forms, including studies,
reports, records, books, subledgers, instruments, surveys, specifications, drawings, blueprints, diagrams, models, prototypes, samples, flow charts, marketing plans, customer names, and other technical, financial, employee or business information or
data, including cost information, sales and pricing data, customer prospect lists, supplier records, customer and supplier lists, customer and vendor data, correspondence and lists, product data and literature, artwork, design, and quality records
and reports; provided that “Information” does not include Merck Intellectual Property. 
 1.29 “In-Licensed IP” has the meaning set forth in Section 2.9.3. 
 1.30 “Interim Services
Agreement” means an agreement entered into between an Affiliate of Merck and an Affiliate of Organon with respect to the provision of Services and payment of Expenses in a specific country. 

1.31 “International Transfer” has the meaning set forth in Section 7.5.5. 

1.32 “IOM Market” means an Interim Operating Model Market as defined in the Separation and Distribution Agreement. 

1.33 “IP License Agreement” means any agreement entered into between Merck or an Affiliate of Merck, on the one hand, and
Organon or an Affiliate of Organon, on the other hand, with respect to the license of any intellectual property in connection with the Separation. 

1.34 “Local Services Agreement” has the meaning set forth in Section 12.9.4. 

1.35 “Longstop Date” means the date that is twelve (12) months after the Effective Date, except for Russia for which it
shall mean the date that is twelve (12) months after the Russia Exit Date (as defined in the NEB Settlement Agreement for Deferred Markets). 

  
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 1.36 “Merck” has the meaning set forth in the Preamble. 

1.37 “Merck Branded Organon Product” means Organon Product labeled with branding of Merck Parent or an Affiliate of Merck.

 1.38 “Merck Indemnitees” has the meaning set forth in Section 9.1. 

1.39 “Merck Intellectual Property” means proprietary information, patents,
know-how, data and other intellectual property, in any form, owned or otherwise controlled by Merck (or its Affiliate) and that either: (i) was used as of the Effective Date to provide any Service to
Organon under this Agreement; or (ii) Merck or its Affiliate has determined to be reasonably necessary for Organon to receive any Service or Expense Activity hereunder. 

1.40 “Merck Parent” has the meaning set forth in the Recitals. 

1.41 “Merck Subsidiary” means any subsidiary of Merck Parent post-Separation (including Merck). 

1.42 “Merck Transition Manager” means the “General Manager” designated by Merck to have general management
responsibility for the provision of Services. The initial Transition Manager shall be designated on or prior to the Effective Date. 
 1.43
“Organon” has the meaning set forth in the Preamble. 
 1.44 “Organon Branded Product” means Organon
Product labeled with branding of Organon Parent or an Affiliate of Organon. 
 1.45 “Organon Business” has the meaning set
forth in the Separation and Distribution Agreement. 
 1.46 “Organon Improvements” has the meaning set forth in
Section 2.9.2. 
 1.47 “Organon Parent” has the meaning set forth in the Recitals. 

1.48 “Organon Products” has the meaning set forth in the Separation and Distribution Agreement. 

1.49 “Organon Subsidiary” means any subsidiary of Organon Parent post-Separation (including Organon). 

1.50 “Organon Transition Manager” means the “General Manager” designated by Organon to have general management
responsibility for the receipt of Services. The initial Transition Manager shall be designated on or prior to the Effective Date. 
 1.51
“Party” or “Parties” has the meaning set forth in the Preamble. 
 1.52 “Payment Claims”
means any rebates, prompt payment discounts, chargebacks, shortage claims, retrospective pricing adjustments, reimbursements and similar items related to the prior sale of an Organon Product; provided that “Payment Claims” do not include
payments in respect of returned products. 

  
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 1.53 “Person” means any individual, corporation, general or limited
partnership, trust, joint venture, unincorporated organization, limited liability entity or other entity or Governmental Authority, including any successor or permitted assignee, by merger or otherwise, of any of the foregoing. 

1.54 “Personal Data” has the meaning set forth in Section 7.5.1. 

1.55 “Personal Data Breach” has the meaning set forth in Section 7.5.1. 

1.56 “Processing” has the meaning set forth in Section 7.5.1. 

1.57 “Records” means Merck’s (or its Affiliate’s or Subcontractor’s, as applicable) records related to
the provision of Services to be provided under this Agreement; provided, however, that with respect to records of existing Subcontractors as of the Effective Date, the term “Records” shall only include the records of a given existing
Subcontractor to the extent that the agreement between Merck (or its Affiliate, as applicable) and such Subcontractor requires such Subcontractor to maintain such records and provide access to such records as set forth in this Agreement (provided,
however, that this shall not relieve Merck or its Subcontractor, as applicable, of its obligations to comply with all Applicable Laws). 

1.58 “Regulatory Agreement” means the Regulatory Agreement for Organon Products entered into between Merck Parent (or one of
its Affiliates) and Organon Parent (or one of its Affiliates). 
 1.59 “Security Regulations” has the meaning set forth in
Section 6.5.1. 
 1.60 “Separation” has the meaning set forth in the Recitals. 

1.61 “Separation and Distribution Agreement” has the meaning set forth in the Recitals. 

1.62 “Separation Date” has the meaning set forth in the Recitals. 

1.63 “Service Fee” means with respect to each Service set forth in the Transition Services Schedule, the agreed quarterly
service fee set forth opposite such Service in the Transition Services Schedule (as it may be amended, restated, modified or supplemented from time to time in accordance with the terms of this Agreement, and if so amended, restated modified or
supplemented, as may be calculated and adjusted in accordance with the principles set forth on Schedule 2 ). 
 1.64 “Service
Fees Schedule” has the meaning set forth in Section 3.1. 
 1.65 “Service Termination Date” has the meaning
set forth in Section 4.2.1. 
 1.66 “Service Termination Notice” has the meaning set forth in Section 4.3.3. 

  
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 1.67 “Services” has the meaning set forth in Section 2.1. 

1.68 “STAIRS Plan” means the plan, as mutually agreed by Organon and Merck (or their respective Affiliates, as applicable),
that details the transfer of Marketing Authorizations, the name change of the holder of the Marketing Authorizations, site name changes, legal entity name and address changes, and artwork changes in connection with the Separation (as such plan may
be amended, restated, modified or supplemented from time to time in accordance with the Regulatory Agreement). 
 1.69
“Subcontractor” means any Person (other than a Party or an Affiliate of a Party) engaged by a Party (or its Affiliate) to perform any Service obligation or Expense Activity of such Party hereunder. 

1.70 “Systems” has the meaning set forth in Section 6.5.1. 

1.71 “Tangible Information” means Information that is contained in written, electronic or other tangible forms. 

1.72 “Term” has the meaning set forth in Section 4.1. 

1.73 “Third Party” means any Person other than Organon or Merck or any of their respective Affiliates. 

1.74 “Third Party Agreement” means any agreement with a Third Party for the provision of goods, a service, lease or license
relating to, or necessary for, the provision of the Services or Expense Activities whether entered into before or after the date of this Agreement. 

1.75 “Third Party Claim” means any and all suits, claims, actions, proceedings or demands brought by a Third Party against
Merck (or the Merck Indemnitees). 
 1.76 “Third Party Consent” means any permission, consent, agreement or authorization
required from a Third Party, whether under a Third Party Agreement or otherwise, for the provision of the Services or Expense Activities by Merck, or the receipt of such Services or Expense Activities by Organon. 

1.77 “Third Party Costs” means any payment or reimbursement made to a Subcontractor or other Third Party for services and/or
goods provided in connection with the activities contemplated under this Agreement. 
 1.78 “Third Party Damages” means all
losses, costs, claims, damages, judgments, liabilities and expenses payable to a Third Party by Merck (or the Merck Indemnitees) under a Third Party Claim (including reasonable attorneys’ fees and other reasonable
out-of-pocket costs of litigation in connection therewith). 

1.79 “Third Party Supplier” means any Third Party providing goods, a service, lease or license under a Third Party Agreement,
including any Subcontractor. 
 1.80 “Third Party In-License” has the meaning set
forth in Section 2.9.3. 

  
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 1.81 “Transaction Documents” means the Separation and Distribution
Agreement and any other agreements entered into between Merck Parent (or any of its Affiliates) and Organon (or any of its Affiliates) in connection with the Separation. 

1.82 “Transition Managers” means the Organon Transition Manager and the Merck Transition Manager. 

1.83 “Transition Services Schedule” has the meaning set forth in Section 2.1. 

1.84 “TSA Exit” means the transition or migration from the provision of a particular Service by Merck to Organon under this
Agreement to performance of such Service by Organon or a Third Party designated by Organon or the end of a Service for which no such transition or migration is required. 

1.85 “VAT” has the meaning set forth in Section 3.6.1. 

2. Services. 
 2.1
Provision of Services. Subject to Section 2.2, commencing on the Effective Date, Merck agrees to use Commercially Reasonable Efforts to provide (itself or through one or more of its Affiliates or Subcontractors) to Organon or its
applicable Affiliates the services described in Schedule 1 (as such schedule may be amended, restated, modified or supplemented from time to time in accordance with the terms of this Agreement, the “Transition Services
Schedule”) for the respective periods and upon the terms and subject to the conditions set forth in this Agreement and the applicable section of the Transition Services Schedule (the “Services”). 

2.2 Additional Services. 

2.2.1 Additional Services. 

(i) Merck shall consider in good faith any reasonable written request by Organon or any of its Affiliates for new services that are not
reflected in the Transition Services Schedule at the time of such request (the “Additional Services”). If Organon desires to request an Additional Service to be provided hereunder by Merck, the Organon Transition Manager shall, no
later than sixty (60) days prior to the requested commencement date of such Additional Service, provide a written request thereof to the Merck Transition Manager describing such Additional Service and the anticipated commencement date thereof.
For example, if an Additional Service is being requested to begin on June 1, 2022, then Organon must request the Additional Service no later than April 2, 2022 (sixty (60) days prior to June 1, 2022). If an Additional Service is
requested that needs to commence within less than sixty (60) days from Organon’s request for such Additional Service, including to comply with a request from a Governmental Authority or any Applicable Law, the Parties will use Commercially
Reasonable Efforts to assess and make final determination pursuant to this Section 2.2.1 on whether such Additional Service will be provided and the terms and conditions and Service Fee for such Additional Service added, notwithstanding the
sixty (60) day and thirty (30) day references in Sections 2.2.1(i) and 2.2.1(ii), respectively. 

  
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 (ii) Within thirty (30) days following the receipt of such request for Additional
Services, the Merck Transition Manager shall provide the Organon Transition Manager with a written response to such request setting forth the applicable Service Fee for such Additional Services (which Service Fee shall be calculated in accordance
with the principles set forth on Schedule 2) and an assessment as to whether the requested commencement date can be achieved. Following receipt by the Organon Transition Manager of the Merck Transition Manager’s response to the
request for Additional Services, the terms and conditions, including the applicable commencement date and the Service Fee (which shall be calculated in accordance with the principles set forth on Schedule 2) on which such Additional Services,
if any, shall be provided by Merck, shall be as mutually agreed upon in writing by the Transition Managers in accordance with Section 5. 

(iii) Upon agreement of the Transition Managers in accordance with this Section 2.2.1 and Section 5, the Transition Services
Schedule and the Service Fees Schedule shall be amended or updated by the Transition Managers to add any such Additional Services and to reflect the Service Fee applicable to such Additional Services. Any agreed Additional Services so provided by
Merck shall constitute Services under this Agreement and be subject in all respects to the provisions of this Agreement as if fully set forth in the Transition Services Schedule as of the date hereof. It is understood that Merck may in its sole and
absolute discretion decline to provide any such Additional Service and Organon acknowledges that Merck shall be under no obligation to provide, and may not have the resources, capabilities or capacity to provide, any Additional Service, and may
determine not to do so for any reason or no reason. 
 (iv) If, after the Effective Date Merck discovers that it, or its Affiliates, is
performing any service for Organon that is not a Service in the Transition Services Schedule and is not a De Minimis Service as determined by Merck, and is not otherwise agreed to pursuant to Section 3.2, Merck shall inform Organon in writing
and Organon may request Merck to add this service as an Additional Service pursuant to this Section 2.2.1. For clarity, if such service is not requested by Organon to be an Additional Service or the terms and conditions and applicable Service
Fee are not mutually agreed to, Merck may stop performing such service. 
 2.2.2 Ad Hoc Services. 

(i) The Transition Services Schedule contains a description of certain services that do not have an applicable Service Fee (“Ad Hoc
Services”). Such Ad Hoc Services shall be provided by Merck upon the mutual agreement of the Parties pursuant to the provisions of this Section 2.2.2 and in accordance with Section 5. If Organon desires that Merck provide an Ad
Hoc Service hereunder, the Organon Transition Manager shall, no later than sixty (60) days prior to the anticipated commencement date of such Ad Hoc Service, provide a written request thereof to the Merck Transition Manager. For example, if an
Ad Hoc Service is being requested to begin on June 1, 2022, then Organon must request such Ad Hoc Service no later than April 2, 2022 (sixty (60) days prior to June 1, 2022). If an Ad Hoc Service is requested that needs to
commence within less than sixty (60) days from Organon’s request for such Ad Hoc Service, including to comply with a request from a Governmental Authority or any Applicable Law, the Parties will use Commercially Reasonable Efforts to
assess and make final determination pursuant to this Section 2.2.2 on whether such Ad Hoc Service will be provided and the terms and conditions and Service Fee for such Ad Hoc Service to be implemented, notwithstanding the sixty (60) day
and thirty (30) day references in Sections 2.2.2(i) and 2.2.2(ii), respectively. 

  
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 (ii) Within thirty (30) days following the receipt of such request for Ad Hoc
Services, the Merck Transition Manager shall provide the Organon Transition Manager with a written response to such request setting forth the applicable Service Fee for such Ad Hoc Services (which Service Fee shall be calculated in accordance with
the principles set forth on Schedule 2). Following receipt by the Organon Transition Manager of the Merck Transition Manager’s response to the request for Ad Hoc Services, the additional terms and conditions, including the
applicable Service Fee (which shall be calculated in accordance with the principles set forth on Schedule 2) on which such Ad Hoc Services, if any, shall be provided, shall be as mutually agreed upon in writing by the Transition Managers in
accordance with Section 5; provided that if the Transition Managers do not mutually agree upon such additional terms and conditions, such Ad Hoc Services shall not be provided hereunder; provided further that any such agreed Ad Hoc Services
shall only be provided by Merck until no later than the applicable Service Termination Date set forth in the Transition Services Schedule and if a longer period is requested by Organon, such Ad Hoc Services shall be treated as Additional Services in
accordance with Section 2.2.1. 
 (iii) Upon agreement of the Transition Managers in accordance with this Section 2.2.2 and
Section 5, the Transition Services Schedule and the Service Fees Schedule shall be updated to reflect the Service Fee and any additional agreed upon terms and conditions applicable to such Ad Hoc Services. Any agreed Ad Hoc Services so
provided by Merck shall constitute Services under this Agreement and be subject in all respects to the provisions of this Agreement as if fully set forth in the Transition Services Schedule as of the date hereof. For the avoidance of doubt, there
may be more than one request for the same Ad Hoc Service that is listed in the Transition Services Schedule, and each such request will be managed pursuant to this Section 2.2.2 and the same line item in the Transition Services Schedule. 

2.2.3 Change in Scope of Service and Increase in Service Fee. 

(i) The Parties agree and acknowledge that Merck may make changes from time to time in the manner of performing the applicable Services if
Merck is making similar changes in performing similar services for itself, its Affiliates or other Third Parties, if any; provided that if any such changes adversely affect the benefits to Organon of Merck’s provision or quality of such Service
in any material respect or increase the Service Fee for such Service, Merck shall provide a written description thereof to Organon and the Transition Managers shall mutually agree (unless such change is required by Applicable Law or a Governmental
Authority, in which case such mutual agreement shall not be required) in writing in accordance with Section 5 to amend the Transition Services Schedule and the Service Fees Schedule to reflect such change and any corresponding increase, if
applicable, in the applicable Service Fee (which increase in the Service Fee shall be calculated in accordance with the principles set forth on Schedule 2). 

  
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 (ii) Organon may request changes to the scope of Services being provided by Merck pursuant
to the Transition Services Schedule. For example, an increase in the volume of activity related to a specific Service due to an acquisition of a company by Organon, would be a change in the scope of such Service. If Organon desires to request a
change in the nature or manner of performing a particular Service or the level at which such Service is to be provided hereunder by Merck, the Organon Transition Manager shall, no later than sixty (60) days prior to the anticipated commencement
date of such change in the scope of such Service, provide a written request thereof to the Merck Transition Manager describing such change. For example, if a change in scope of a Service is being requested to begin on June 1, 2022, then Organon
must request the change in scope of such Service no later than April 2, 2022 (sixty (60) days prior to June 1, 2022). If a change in scope of a Service is requested that needs to commence within less than sixty (60) days from
Organon’s request for such change in scope of a Service, including to comply with a request from a Governmental Authority or any Applicable Law, the Parties will use Commercially Reasonable Efforts to assess and make final determination
pursuant to this Section 2.2.3 on whether such change in scope of a Service will be provided and the terms and conditions and revised Service Fee, for any increase in scope, for such Service, notwithstanding the sixty (60) day and thirty
(30) day references in Sections 2.2.3(ii) and 2.2.3(iii), respectively.     
 (iii) Within thirty (30) days
following the receipt of such request from the Organon Transition Manager, the Merck Transition Manager shall provide the Organon Transition Manager with a written response to such request setting forth any applicable increase in the Service Fee
(which increase in the Service Fee shall be calculated in accordance with the principles set forth on Schedule 2). Following receipt by the Organon Transition Manager of the Merck Transition Manager’s response to the request for a change
in the scope of a particular Service, the new terms and conditions, including any applicable increase in the Service Fee (which increase in the Service Fee shall be calculated in accordance with the principles set forth on Schedule 2) on
which such Service shall be provided shall be as mutually agreed upon in writing by the Transition Managers in accordance with Section 5; provided that if the Transition Managers do not mutually agree upon such new terms and conditions, the
scope of such Service and the Service Fee shall not be amended hereunder. 
 (iv) Upon agreement of the Transition Managers in accordance
with this Section 2.2.3 and Section 5, the Transition Services Schedule and the Service Fees Schedule shall be amended or updated by the Transition Managers to reflect any changes to the scope of any such Services and any increase in the
Service Fee applicable to such Services (which increase in the Service Fee shall be calculated in accordance with the principles set forth on Schedule 2). Any reduction to the scope of a Service shall not reduce or otherwise change the
applicable Service Fee and the Service Fee in effect prior to any such reduction shall remain in effect through the applicable Service Termination Date (unless otherwise subsequently modified in accordance with this Agreement) and Organon shall
continue to be liable for paying the Service Fee related to any such reduced Service until the applicable Service Termination Date (unless otherwise subsequently modified in accordance with this Agreement). 

2.2.4 De Minimis Services. Without limiting any other provisions of this Section 2.2, Merck may, in its sole discretion, perform
certain additional de minimis services that are incidental to the Services conducted hereunder and that are not material in nature (and Merck shall consider any reasonable request by Organon or any of its Affiliates for such de minimis services)
(the “De Minimis Services”); provided, however, that whether Merck will provide such De Minimis Services shall be in Merck’s sole discretion. The De Minimis Services, if any, shall constitute Services under this Agreement and
shall be subject in all respects to the provisions of this Agreement; provided, however, that (i) the De Minimis Services will not be reflected in the Transition Services Schedule and (ii) the De Minimis Services shall be provided at
Merck’s sole cost and expense (i.e. there shall be no Service Fee with respect to any De Minimis Services). For the avoidance of doubt, any support provided by Merck to Organon pursuant to Section 3.2 shall not be considered De Minimis
Services. 

  
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 2.3 Information. 

2.3.1 All Tangible Information supplied to Organon by Merck pursuant to this Agreement shall be provided in Merck’s standard format as in
existence on the Effective Date. All Information will be supplied in its existing language without any translation required by Merck. Merck reserves the right to redact such Information where required. Merck reserves the right to change the format
of the Information supplied to Organon to accommodate any upgrades or improvements in Merck’s existing systems, software or hardware or for other reasonable business reasons. Organon can request that Information be supplied in a format that is
different from Merck’s standard format in existence on the Effective Date or the format as subsequently changed by Merck pursuant to the preceding sentence by providing a written request thereof to Merck, which written request shall contain
Organon’s rationale for the requested change in format to a non-standard format. If Merck, in its sole discretion and upon the request of Organon, accommodates such request to provide Information in a non-standard format requested by Organon, the Expenses of any such provision of Information, calculated in accordance with the principles set forth on Schedule 2, shall be the responsibility of Organon and
Merck shall be reimbursed for any such Expenses incurred in connection with accommodating Organon’s request. Merck shall not be required to make any upgrade or improvements to its existing systems, software or hardware on behalf of Organon in
order to provide any Services, Expense Activities or Information in any different format. 
 2.3.2 In connection with a TSA Exit, in
accordance with the TSA Exit plan, Merck will use Commercially Reasonable Efforts and will cause its Affiliates to use Commercially Reasonable Efforts to support any transfer of Records concerning the Organon Products and related to such Service to
Organon in accordance with the applicable TSA Exit plan. If requested by Organon in connection with the prior sentence during the Term, Merck will deliver and will cause its Affiliates to deliver to Organon, within such time periods as the Parties
may reasonably agree, all Records received or computed for the benefit of Organon related to such Service prior to the applicable Service Termination Date, the scope of such Records as mutually agreed, in electronic and/or hard copy form; provided,
however, that (i) Merck will not have any obligation to provide or cause to provide Records in any format other than the current format Merck maintains, and (ii) the Expenses of any such provisions of Records, calculated in accordance with
the principles set forth on Schedule 2, shall be the responsibility of Organon and Merck shall be reimbursed for such Expenses incurred in connection with accommodating Organon’s request. 

2.3.3 Upon the request of Organon, Merck shall provide any Tangible Information specifically related to the Organon Products or the Organon
Business that is not being provided under a Service with an associated Service Fee in the Transition Services Schedule; provided that the scope, timing, and cost for providing such Tangible Information shall be mutually agreed upon and the costs for
providing such Tangible Information charged to Organon as Expenses, which shall be calculated in accordance with the principles set forth on Schedule 2 including any applicable mark up. Notwithstanding the rest of this Section 2.3.3,
requests for provision of Tangible Information specifically related to the Organon Products or the Organon Business that is contained within structured data in Merck Systems will be managed pursuant to Section 3.2.8. 

  
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 2.3.4 Any Expenses incurred by Merck pursuant to this Section 2.3 for which Organon is
responsible shall be invoiced by Merck to Organon in accordance with Section 3.3. For avoidance of doubt, such Expenses may include the reasonable costs of gathering, redacting where required, copying, transporting and otherwise complying with
the request with respect to such Information. 
 2.3.5 Any requests for Records concerning the Services, or Tangible Information
specifically related to the Organon Products or the Organon Business after the Term shall be handled pursuant to, and in accordance with, the applicable provisions of the Separation and Distribution Agreement. 

2.4 Limitation on Service Obligations. Without limiting its obligations pursuant to Section 6.1, Merck shall be entitled to
determine the manner in which it performs the Services and Expense Activities. Without limiting the generality of the foregoing, Merck will in no case be obligated to (i) hire any additional employees or increase the scope of responsibilities
of its existing employees, (ii) maintain the employment of any specific employee, (iii) purchase, lease or license any additional equipment or software, or (iv) expand its facilities, incur capital expenses or develop new business
processes. In addition, Merck shall have no obligation to (i) upgrade, enhance or otherwise modify any computer hardware, software or network environment currently used by Organon or otherwise, or to provide any support or maintenance services
for any computer hardware, software or network environment that has been upgraded, enhanced or otherwise modified by or on behalf of Organon, or (ii) provide to Organon any legal or tax advice or any assistance in negotiating any contracts or
agreements that Organon will enter into. 
 2.5 Provision of Services. Organon acknowledges that Merck may be performing or providing
services similar to the Services or Expense Activities (and/or services that involve the same resources as those used to provide the Services or Expense Activities) to its internal organizations, Affiliates and Third Parties. Merck reserves the
right to modify the Services and Expense Activities to the extent the same changes are made to such similar services that it uses or provides to its internal organizations, Affiliates and Third Parties in the ordinary course of business. In no event
shall Merck be required to make any customization to the Services or Expense Activity (or Merck’s Systems or processes) that is unique to Organon. Organon acknowledges that Merck is not in the business of providing services to Third Parties and
that Merck is entering into this Agreement only in connection with the Separation and Distribution Agreement. 
 2.6 Necessary
Suspension. Merck will use Commercially Reasonable Efforts to provide the applicable Services and Expense Activities during the applicable periods during the Term. In the event, however, that Merck, in the normal course of the operations in
accordance with the historical practice of the past twelve (12) months prior to commencement of a Service or Expense Activity, determines to suspend delivery of a Service or Expense Activity hereunder for purposes of computer system backups,
inspections, maintenance, software patches, repair, replacement of equipment parts or structures, security, or other similar activities, Merck shall not 

  
 13 

 be obligated to deliver such Services or Expense Activities during such periods; provided that
(i) Merck shall use Commercially Reasonable Efforts to inform Organon in writing prior to any scheduled interruption; and (ii) Merck will use Commercially Reasonable Efforts to limit the disruption of Organon’s business caused by such
suspension. Without limiting the generality of the foregoing, Merck may, from time to time and in its sole discretion, also perform additional information technology upgrades that may result in Service or Expense Activity outages or undertake other
activities that may result in Service or Expense Activity outages (in each case, even if not in the normal course of the operations in accordance with the historical practice of the past twelve (12) months prior to commencement of a Service)
and Merck may make such upgrades regardless of whether any such upgrade results in such an outage; provided that such information technology upgrades or other activities, as applicable, do not negatively affect Merck’s provision of the Services
or Expense Activities in any material respect. 
 2.7 Subcontractors. Merck may subcontract or otherwise delegate the performance of
all or any of its obligations under this Agreement (including, for the avoidance of doubt, any of the Schedules attached hereto) to any of Merck’s Affiliates or any Subcontractor solely to the extent such subcontract or delegation does not
conflict with Applicable Law. If, in accordance with the foregoing, Merck exercises its rights or performs its obligations under this Agreement through an Affiliate or Subcontractor, then Merck shall remain solely responsible for the acts, omissions
and performance of such Affiliate or Subcontractor as if such acts, omissions and performance had been provided by Merck itself under this Agreement. In addition, in each case where a Merck Affiliate has an obligation pursuant to this Agreement or
performs an obligation pursuant to this Agreement: (i) Merck shall cause and compel such Affiliate to perform such obligation and comply with the terms of this Agreement; and (ii) any breach of the terms or conditions of this Agreement by
such Affiliate shall be deemed a breach by Merck of such terms or conditions. Organon shall be responsible for any additional costs or expenses arising under this Section 2.7 in connection with the addition or use of any such Subcontractor to
perform Services or Expense Activities hereunder or the change of any Subcontractor previously performing Services or Expense Activities hereunder and Merck shall have the right to pass-through such additional fees to Organon (and, for the avoidance
of doubt, any applicable Service Fee(s) set forth on the Transition Services Schedule and incorporated in the Service Fees Schedule shall be revised to include such fees, and the amount of any applicable Expenses to be reimbursed pursuant to
Section 3.2 shall be adjusted); provided, however, (x) to the extent that a Subcontractor is changed solely due to Merck’s preference (and, for clarity, not due to the previous Subcontractor’s inability to adequately provide a
Service or Expense Activity) or (y) a new Subcontractor is utilized by Merck to provide a Service or Expense Activity that was previously provided to Organon using Merck’s internal resources, then, in each case, any additional fees shall
not be Expenses for which Organon shall be responsible and Merck shall bear any such additional fees (and, for the avoidance of doubt, there shall be no change in the applicable Service Fee(s) set forth on the Transition Services Schedule). 

2.8 Third Party Suppliers. 

2.8.1 Third Party Consents. 

(i) Merck shall use its Commercially Reasonable Efforts to obtain and maintain for the Term any Third Party Consents that are necessary for
Merck’s provision to, and Organon’s receipt of, the Services and Expense Activities, except that Merck shall have no obligation to obtain any Third Party Consents in respect of any Covered Personal Data. 

  
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 (ii) Organon shall provide Merck with such assistance as Merck may reasonably request to
obtain Third Party Consents, including assistance with negotiating the terms of Third Party Consents with Third Party Suppliers. 
 (iii)
Any Expenses imposed by a Third Party for the provision of any Third Party Consent that is required in respect of the Services or Expense Activities shall be borne by Organon and Merck shall have the right to pass-through such additional Expenses to
Organon or, if applicable, adjust the applicable Service Fee(s) set forth on the Transition Services Schedule and incorporated in the Service Fees Schedule; provided that Merck shall use its Commercially Reasonable Efforts to seek to minimize the
Expenses imposed by a Third Party for the provision of such Third Party Consents that are required in respect of the Services or Expense Activity. 

2.8.2 Dependence on Third Parties. 

(i) Where a Third Party Consent or Third Party Agreement is required in order for Merck to provide, or procure the provision of, any element
of a Service or Expense Activity (a “Dependent Service Element”) but: 
 (a) such Third Party Consent either: 

(1) has not been obtained; or 

(2) has expired or been terminated or been revoked by the Third Party Supplier; or 

(b) the obtaining of that Third Party Consent requires the payment of an Expense to the relevant Third Party Supplier that: 

(1) is not expressly itemized in the Service Fee set forth on the Transition Services Schedule or the Service Fees Schedule; and 

(2) Organon does not pay (without limiting Organon’s obligations under Section 2.8.1(iii)); or 

(c) such Third Party Agreement either has been terminated or not extended or not renegotiated following expiration on substantially similar
terms (including pricing terms and any terms related to performance thereunder), 
 then Merck shall not be obliged to provide, or procure the provision of,
the Dependent Service Element. 

  
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 (ii) Notwithstanding anything to the contrary set forth herein, the ability of Merck to
provide each Service or Expense Activity hereunder shall be subject to the performance of any applicable Third Party Supplier and the terms, conditions and other provisions of any applicable Third Party Agreement. Merck shall use Commercially
Reasonable Efforts to enforce its rights under any applicable Third Party Agreement. Merck shall notify Organon in writing, as soon as reasonably practicable, upon it becoming aware of any threatened or actual failure to obtain revocation,
termination or expiry of the relevant Third Party Consent or Third Party Agreement if it will adversely impact the ability of Merck to provide the applicable Service to Organon or Expense Activity. Upon receiving such notification, Organon and Merck
shall cooperate in good faith to obtain or renew any such Third Party Consent or Third Party Agreement. Any increased cost associated with such new Third Party Consent or renewal, that is applicable or allocable to a Service or Expense Activity,
shall be borne by Organon and Merck shall have the right to pass-through any such increased Expenses to Organon. 
 (iii) Upon
Organon’s request, Merck shall use its Commercially Reasonable Efforts to implement alternative arrangements providing substantially similar services in place of the Dependent Service Element. The cost of putting alternative arrangements in
place under this Section 2.8.2(ii) shall be borne by Organon and Merck shall have the right to pass-through such additional Expenses to Organon. The Parties shall use Commercially Reasonable Efforts to seek to minimize the cost of putting
alternative arrangements in place under this Section 2.8.2(ii). Notwithstanding the foregoing, Merck shall not be required to put alternative arrangements in place under this Section 2.8.2(ii) if Organon itself is able to perform the
service or services comprising the Dependent Service Element or if Organon can procure the Dependent Service Element from a Third Party at a reasonable cost. 

2.9 Intellectual Property. 

2.9.1 Merck Intellectual Property. As between the Parties, Merck (or its Affiliate) shall own all right, title and interest in
and to the Merck Intellectual Property (including any and all information contained therein), and Organon is not acquiring any ownership interest in any Merck Intellectual Property (including any and all information contained therein) under this
Agreement. 
 2.9.2 IP Generated from the Provision of Services. Unless otherwise agreed in writing by the Parties or as otherwise
set forth in any Transaction Document, all discoveries, improvements or inventions by Merck or any of its Affiliates, whether or not patentable, solely relating to an Organon Product and that directly result and arise from Merck’s or its
Affiliates’ performance of the Services hereunder (“Organon Improvements”), shall be the sole and exclusive property of Organon and shall be deemed to be Confidential Information of Organon for purposes of this
Agreement. Within thirty (30) days of becoming aware of any such Organon Improvement, Merck shall notify Organon, in writing, of the event and, upon Organon’s written request and at Organon’s sole expense, shall reasonably assist
Organon in protecting Organon’s proprietary rights to such Organon Improvement. Merck and its Affiliates shall assign, and hereby does assign, its entire right, title and interest in and to the Organon Improvements to Organon. 

  
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 2.9.3 In-Licensed IP; Third-Party In-Licensed IP. To the extent any software or intellectual property is provided as part of, or used to perform, any Service or Expense Activity and is licensed to Merck or any of its Affiliates by a Third Party
(“In-Licensed IP”) pursuant to a contract to which such Third Party and Merck (or its Affiliate) are parties (a “Third Party
In-License”), then: (i) to the extent the terms of such Third Party In-License are provided to or communicated to Organon or its Affiliates, Organon shall,
and shall ensure its Affiliates, comply with the applicable obligations and other terms and restrictions of such Third Party In-License, (ii) Organon and its Affiliates shall only use the In-Licensed IP to the extent necessary in accordance with this Agreement, and (iii) Merck makes no representations or warranties of any kind with respect to the
In-Licensed IP and shall have no liability with respect to such In-Licensed IP other than to use Commercially Reasonable Efforts to pass through to Organon and its
Affiliates any rights and benefits under the Third Party In-License. Except as otherwise set out in this Agreement, Merck does not (and does not purport to) assign or grant any rights or licenses in the In-Licensed IP to Organon or its Affiliates and any proprietary rights vesting in the same shall continue to be held by the applicable Third Party or its licensors. If Organon or any of its Affiliates materially
breaches the terms of a Third Party In-License, then Merck may, upon written notice to Organon and without liability to Merck or any of its Affiliates, suspend or terminate Organon’s or its
Affiliates’ access to the applicable In-Licensed IP that is the subject of such Third Party In-License. 

2.9.4 Licenses. Each Party shall grant to the other Party such rights and licenses to such intellectual property, documentation and
Information as shall be necessary for the other Party to perform its respective obligations and to exercise its respective rights under this Agreement. 

2.9.5 IP License Agreements. This Section 2.9 and the terms hereof shall be subject to the terms and conditions of any IP License
Agreement and in the event of a conflict between this Section 2.9 and any IP License Agreement, such IP License Agreement shall control. 

2.10 Services Recipient. Notwithstanding anything to the contrary herein, unless otherwise mutually agreed in writing, (i) only
Organon and its Affiliates shall be entitled to have access to the Services and Expense Activities under this Agreement, (ii) Organon shall not, directly or indirectly, resell or permit the use of any of the Services or Expense Activities to or
by any other person or entity, and (iii) in no event shall Organon, its Affiliates or their respective employees, third-party technology consultants or other personnel be entitled to modify any Merck System or the Services or Expense
Activities. 
 3. Payment. 

3.1 Service Fees. In consideration for the provision of Services specified in the Transition Services Schedule by Merck, Organon will
pay the applicable Service Fees to Merck pursuant to Schedule 3 (as amended or modified from time to time, including to add Service Fees for Calendar Quarters not included in the initial version of Schedule 3, the “Service Fees
Schedule”). The Service Fees may be adjusted pursuant to the provisions of this Agreement. 
 3.1.1 Service Fees for Certain
Quality-Related Services. For certain product quality-related Services that could have a duration of up to five (5) years, and are indicated as such in the Transition Services Schedule, the related Service Fees indicated in the Transition
Services Schedule will be adjusted as follows beginning January 1, 2024. 

  
 17 

	 	•	 	 For Calendar Year 2024, the monthly Service Fee, effective starting January 1, 2024, will be reduced
twenty-five percent (25%) from the monthly Service Fee in effect for December 2023. 

  

	 	•	 	 For Calendar Year 2025, the monthly Service Fee, effective starting January 1, 2025, will be reduced by
thirty-three percent (33%) from the monthly Service Fee in effect for December 2024. 

  

	 	•	 	 For the first half of Calendar Year 2026, the monthly Service Fee, effective starting January 1, 2026, will
be reduced by fifty percent (50%) from the monthly Service Fee in effect for December 2025. 

 If either Party believes that any of the
above adjustments results in an aggregate of Service Fees for the total of all such Services pursuant to this Section 3.1.1 that is not representative of the costs associated with the total volume of activity associated with such Services in
aggregate for a given Calendar Year, such Party may, prior to November 1st of the preceding Calendar Year, request discussion and review by the Transition Managers to determine if a different adjustment should be applied. Such determination shall be
mutually agreed upon in writing by the Transition Managers in accordance with Section 5; provided that if the Transition Managers do not mutually agree, the Service Fees for such Services shall be adjusted in accordance with the adjustments
noted in this Section 3.1.1. 
 3.1.2 Reconciliation of Certain Service Fees. With respect to certain Services that are
specifically designated as being subject to this Section 3.1.2 in the Transition Service Schedule as of the Effective Date, the actual expense of providing such Services will be reconciled at the end of each Calendar Year versus the Service
Fees charged and any difference invoiced (or credited) to Organon in accordance with Section 3.3. 
 3.2 Expenses. 

3.2.1 Additional Expenses. Subject to this Section 3, to the extent that Merck or its Affiliates incurs any internal or Third
Party costs, fees, charges or expenses (each, an “Expense”) specifically related to the Organon Products or Organon Business that are not related to a Service (including pursuant to Sections 2.3, 2.7, 2.8, 3.1.2, 3.2.1, 3.2.2,
3.2.3, 3.2.4, 3.2.5, 3.2.6, 3.2.7, 3.2.8, 3.2.9, 3.6 and 3.8) or otherwise reimbursed pursuant to any other Transaction Document, Merck shall: (i) invoice such Expenses quarterly, including any applicable markup in accordance with Schedule
2, in the next relevant invoice issued to Organon; and (ii) upon the reasonable request of Organon, provide reasonable substantiation of all such Expenses to Organon. Invoicing and payment of such Expenses shall be in accordance with
Section 3.3. Each such invoice shall set forth a reasonable description of such Expenses in the general format of Schedule 4 hereto and the amount of such Expenses payable for such Calendar Quarter. 

3.2.2 Third Party Fees. Organon shall be financially responsible for any Expenses, including filing fees, payable to any Governmental
Authority or other Third Parties related to the Organon Products. If Merck or any of its Affiliates makes any payment of any such Expenses to a Governmental Authority or other Third Party on behalf of Organon, Organon shall reimburse Merck the
amount of such Expenses paid. 

  
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 3.2.3 STAIRS Plan Expenses Pursuant to Regulatory Agreement. Organon shall be
financially responsible for any Expenses related to the STAIRS Plan for Organon Products. In addition to the payment of any applicable Service Fee hereunder, any Expenses incurred with respect to the planning and execution, including the costs
associated with artwork and any resulting Discards related to Organon Products, of the STAIRS Plan pursuant to the Regulatory Agreement shall be borne by Organon and Merck shall have the right to charge such Expenses to Organon (such Expenses as
calculated in accordance with the principles set forth on Schedule 2). 
 3.2.4 Recalls Expenses Pursuant to Regulatory
Agreement. In addition to the payment of any applicable Service Fee hereunder, any Expenses incurred with respect to recalls or market withdrawal of Organon Products pursuant to the Regulatory Agreement shall be borne by Organon and Merck shall
have the right to charge such Expenses to Organon (such Expenses as calculated in accordance with the principles set forth on Schedule 2).

3.2.5 Product Returns and Discards. Unless otherwise agreed in writing by the Parties or as otherwise set forth in any Transaction
Document and subject to Applicable Law: 
 (i) From the Effective Date and all times thereafter, Merck shall be responsible for handling,
processing, providing refunds or replacements for, destroying, and otherwise administering all returns of Merck Branded Organon Product sold by Merck. In each case, such returns shall be handled in accordance with Merck’s then-current returned
goods policy. Returns of Organon Product where the original selling entity is unknown shall not be accepted and credit will not be provided by Merck. In no event shall Merck process returns for Organon Branded Product. In no event shall Merck
process returns for Merck Branded Organon Product sold by Organon. 
 (ii) From the Effective Date and at all times thereafter, Organon, to
the extent legally authorized to do so, shall be responsible for handling, processing, providing refunds or replacements for, destroying and otherwise administering all returns of Organon Branded Product, Merck Branded Organon Product sold by
Organon, and all cases where the original selling entity is unknown. In each case, such returns shall be handled in accordance with Organon’s then-current returned goods policy. Organon shall not be responsible for processing of returns of
Merck Branded Organon Products that were sold by Merck. 
 (iii) From the Effective Date until the Longstop Date, Organon shall be
financially responsible for all costs (including the costs of credits and replacements provided in connection with such returns) associated with Merck Branded Organon Product returns sold by Merck. From the Effective Date and all times thereafter,
Organon shall be financially responsible for all costs (including the costs of credits and replacements provided in connection with such returns) associated with returns of Organon Branded Product and Merck Branded Organon Product sold by Organon
and for any Organon Product where the original selling entity is unknown. 
 (iv) From the Effective Date until the Longstop Date each
Party: (a) shall promptly notify the other Party of receipt of any Organon Product incorrectly returned to that Party (with reference to the terms of this Agreement or pursuant to Applicable Law) and shall keep adequate records regarding such
returned Organon Products; and (b) shall send back to the relevant customer any Organon Product that is returned to the incorrect entity, and direct such customer to return the Organon Product to the correct Party. 

  
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 (v) If a Third Party contacts Organon regarding the return of any Merck Branded Organon
Product that was sold by Merck, Organon shall refer such Third Party to Merck. If a Third Party contacts Merck regarding the return of any Merck Branded Organon Product that was sold by Organon, Merck shall refer such Third Party to Organon. If a
Third Party contacts Merck regarding return of any Organon Branded Product, Merck shall refer such Third Party to Organon. 
 (vi) From the
Effective Date until the Longstop Date, neither Organon nor Merck shall instruct, recommend or attempt to induce customers who have previously purchased Organon Product to return such Organon Product when that would not otherwise have been the case
but for such Party’s instructions, recommendations or inducement, except in the event of recall, as required by Applicable Law. 

(vii) For clarity, Third Parties that have purchased Merck Branded Organon Product on or prior to the Effective Date may continue to sell such
Organon Product to customers in the ordinary course of business. Following the expiration of any Grace Period, Organon shall discard and destroy any remaining Merck Branded Organon Product and provide certificates of destruction, which shall, upon
Merck’s request, be made available for inspection. 
 (viii) From the Effective Date and at all times thereafter, Organon shall be
financially responsible for all costs and expenses associated with Discards of returned Organon Product sold by Organon, whether Merck Branded Organon Product or Organon Branded Product (including the supply price for the underlying Organon
Products). From the Effective Date until the Longstop Date, Organon shall be financially responsible for all costs and expenses associated with Discards of returned Merck Branded Organon Product sold by Merck. For the avoidance of doubt, Organon
shall at all times be financially responsible for all costs and expenses associated with Discards (including the supply price for the underlying Organon Products) of Organon Branded Product. 

(ix) For the avoidance of doubt, the costs and expenses included in this Section 3.2.5 that are incurred by one Party but the
responsibility of the other Party, shall be Expenses and reimbursed in accordance with Section 3.3. 
 3.2.6 Payment Claims.
Unless otherwise agreed in writing by the Parties or as otherwise set forth in any Transaction Document and subject to Applicable Law: 

(i) With respect to processing transactional data and government pricing data related to the sale of Organon Products, Merck and Organon agree
to work in good faith to ensure compliance with commercial contracts, government programs and the related price reporting requirements in an accurate and timely manner. 

(ii) From the Effective Date and at all times thereafter, Organon shall be operationally responsible for processing and financially
responsible for paying all Payment Claims that are associated with all Organon Branded Product and Merck Branded Organon Product sold by Organon, and with all Merck Branded Organon Product for which it is not possible to identify whether the
original selling entity was Merck or Organon. 

  
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 (iii) For the avoidance of doubt, from the Effective Date and at all times thereafter,
Merck shall be operationally responsible for processing and financially responsible for paying all Payment Claims that are associated with Merck Branded Organon Product sold by Merck. 

(iv) For the avoidance of doubt, the costs and expenses included in this Section 3.2.6 that are incurred by one Party but the
responsibility of the other Party, shall be Expenses and reimbursed in accordance with Section 3.3. 
 3.2.7 Reimbursement of
Expenses Related to IOM Market and Deferred Market Cutover Plans. For any support, with the exception of that for a COMET ERP Transition (as defined in Schedule 5), by Merck for Cutover Plans associated with IOM Markets and Deferred
Markets (which support shall be consistent with the applicable agreed Cutover Plan (or completed after the Effective Date in preparation for such Cutover Plan), including an estimate of the Third Party related Expenses, for any such IOM Market or
Deferred Market), Organon shall reimburse Merck for all related Third Party related Expenses, calculated in accordance with the principles set forth on Schedule 2. Invoicing and payments for such Third Party related Expenses to be reimbursed
pursuant to this Section 3.2.7 for each such IOM Market Cutover Plan and Deferred Market Cutover Plan shall be included in the invoices and payments to be made in accordance with Section 3.3. Expenses associated with the COMET ERP
Transition for each IOM Market and Deferred Market will be fixed in advance for each such country as indicated in Schedule 5, and Organon’s reimbursement obligation related to the COMET ERP Transition of each such IOM Market and Deferred
Market shall be limited to such quarterly amounts and durations (which may be extended by Merck if the Exit Date is delayed for such IOM Market or Deferred Market; provided that during such extension the quarterly amounts will be adjusted to include
only Third Party related Expenses that are Third Party related Expenses applicable to the extension that were not included in the fixed quarterly amounts charged prior to such extension) indicated on Schedule 5 for each such country, and
invoicing and payments of such Expense in accordance with Section 3.3 will initiate following the Effective Date, as applicable for a specific IOM Market or Deferred Market. 

3.2.8 Reimbursement of Expenses Related to IT Projects. For any IT project support by Merck that is requested by Organon that is
not included in any Service listed in the Transition Services Schedule, not related to a Cutover Plan for an IOM Market or a Deferred Market, and not related to a TSA Exit pursuant to Section 3.2.9, if Merck agrees to provide the requested
support (which agreement shall not be required in the case of a request for Tangible Information specifically related to the Organon Products or the Organon Business that is contained within structured data in Merck Systems) then Merck shall provide
an estimate of the Expenses for such support and the scope of work to be completed by Merck and the estimated duration for the completion of the support. If Organon agrees to proceed with such IT project, Merck shall complete the project work and be
reimbursed for all related Expenses, calculated in accordance with the principles set forth on Schedule 2. If, at any time, Merck determines that the actual Expenses for any such support provided under this Section 3.2.8 will exceed the
estimated Expenses by greater than ten percent (10%), Merck shall inform Organon who may decide for Merck to continue such support or cease such support. If Organon decides to cease such support, Merck shall invoice, and Organon shall pay, for any
Expenses incurred prior to the cessation of support and any related non-cancelable Expenses. 

  
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 3.2.9 Reimbursement of Expenses Related to TSA Exits. For any support by Merck for
TSA Exits (which support shall be consistent with the applicable agreed TSA Exit plan (or completed after the Effective Date in preparation for such TSA Exit plan), including an estimate of the Expenses, for such TSA Exit support), Organon shall
reimburse Merck for all related Expenses, calculated in accordance with the principles set forth on Schedule 2. Invoicing and payments for such Expenses to be reimbursed pursuant to this Section 3.2.9 for each such TSA Exit shall be
included in the invoices and payments to be made in accordance with Section 3.3. If, at any time, Merck determines that the actual Expenses for any such support provided under this Section 3.2.9 will exceed the estimated Expenses by
greater than ten percent (10%), Merck shall inform Organon who may decide for Merck to continue such support or cease such support. If Organon decides to cease such support, Merck shall invoice, and Organon shall pay, for any Expenses incurred prior
to the cessation of support and any related non-cancelable Expenses. 
 3.3 Payment Timing.

 3.3.1 Within thirty (30) days following the end of the Calendar Month that includes the Effective Date, and within thirty
(30) days following each Calendar Month thereafter, Merck (or Merck’s Affiliate, as applicable) will deliver to Organon (or Organon’s Affiliate, as applicable) an invoice pursuant to the Service Fees Schedule for the global Services
on the Transition Services Schedule and invoices for local Services on the Transition Services Schedule with such invoices for global and local Services being in accordance with the Service Fees Schedule during such Calendar Month. Each such invoice
shall set forth a description of such Services in the general format of Schedule 4 hereto and the Service Fees payable in accordance with the Service Fees Schedule. For the avoidance of doubt, such invoices shall not be limited to Service
Fees related to the Calendar Month covered by such monthly invoice but may include Service Fees from Calendar Months prior to such Calendar Month. 

3.3.2 Within thirty (30) days following the end of the Calendar Quarter that includes the Effective Date, and within thirty
(30) days following each Calendar Quarter thereafter, Merck (or Merck’s Affiliate, as applicable) will deliver to Organon (or Organon’s Affiliate, as applicable) an invoice for global Expenses that are to be charged through to Organon
in accordance with the terms of this Agreement and invoices for local Expenses that are to be charged through to Organon in accordance with the terms of this Agreement incurred during such Calendar Quarter. Each such invoice shall set forth a
break-down of the applicable Expenses to be charged to Organon. For the avoidance of doubt, such invoices shall not be limited to Expenses related to the Calendar Months in the Calendar Quarter covered by such quarterly invoice but may include
Expenses from Calendar Months prior to such Calendar Quarter. 
 3.3.3 Organon will pay to Merck, by wire transfer to an account specified
in the invoice, such Service Fees and Expense amounts within thirty (30) days after Organon receives such invoice pursuant to Section 3.3.1 or Section 3.3.2, as applicable. All invoices issued by Merck under this Agreement and all
payments to be made by Organon under this Agreement, with respect to Services, shall be made in accordance with the Service Fees Schedule. 

  
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 3.4 Currency Conversion. The rate of exchange to be used in computing the currency
equivalent in Dollars of any payment (including, for the avoidance of doubt, any adjustment to a Service Fee, the determination of a Service Fee for a new Service, or any Expense) due hereunder shall be made at the monthly rate of exchange utilized
by Merck and its Affiliates in their worldwide accounting system. 
 3.5 Disputed Amounts. Any good faith dispute over an amount due
pursuant to this Article 3 will be subject to the provisions of Section 12.3. Except as the Parties may expressly agree in writing, amounts due under this Agreement may not be offset by amounts due under any other agreement. 

3.6 Taxes. 
 3.6.1
VAT; Similar Taxes. The Service Fees and Expenses shall be exclusive of any value added tax, sales tax or any other similar type of turnover tax (collectively, “VAT”) which may be due and payable by Merck or any of its
Affiliates to a Governmental Authority and Organon shall pay any such VAT in addition to the sums otherwise payable, at the rate in force at the due time for payment or such other time as is stipulated under the relevant VAT legislation; provided,
however, that Organon shall not pay any such VAT unless and until Merck provides a correct invoice in accordance with the relevant VAT legislation. Merck shall be liable for other taxes such as rent, use, and personal property taxes and for taxes on
any and all income or revenues received from Organon under this Agreement. 
 3.6.2 Withholding Taxes. In the event any payments made
pursuant to this Agreement are or become subject to withholding taxes under the laws or regulations of any jurisdiction, the Party making such payment shall be entitled to deduct and withhold the amount of such taxes for the account of the payee to
the extent required by Applicable Laws and such amounts payable to the payee shall be reduced by the amount of taxes deducted and withheld. Any such withholding taxes required under Applicable Laws to be paid or withheld shall be an expense of, and
borne solely by, the payee. If the Party making payment pursuant to this Agreement fails to deduct and withhold all or a portion of the amount of tax required by Applicable Law to be deducted and withheld and such Party is required by Applicable Law
to pay all or a portion of such tax to a Governmental Authority for the account of the payee, payee shall, upon request from the other Party, immediately pay to the other Party an amount equal to the amount paid to such Governmental Authority for
the account of the payee. 
 3.6.3 Tax Cooperation. To the extent that the Party making a payment is required to deduct and withhold
taxes on any payments under this Agreement, the Party making such payment shall pay the amounts of such taxes to the proper Governmental Authority in accordance with Applicable Laws and in a timely manner transmit to the payee an official tax
certificate or other evidence of such withholding as required by Applicable Law. It is the responsibility of the payee to provide any tax forms to the Party making such payment that may be reasonably necessary in order for such Party not to withhold
tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. The payee shall use reasonable efforts to provide any such tax forms to the Party making the payment at least thirty (30) days prior to the due date for
any payments for which the payee desires that the Party making the payment apply a reduced withholding rate. Each Party shall provide the other with reasonable assistance to enable the recovery and reduction, as permitted by Applicable Laws, of
withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party (or Affiliate thereof) bearing such withholding tax or VAT. 

  
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 3.7 Other Rights. Payment of an invoice or any other amounts hereunder shall not
preclude Organon from exercising its audit rights under the terms of Section 10 of this Agreement, shall not be deemed a release of any potential claims against Merck, and shall not limit Organon from pursuing any other remedy available to
Organon under this Agreement or under Applicable Laws. 
 3.8 Interest. Any payments under this Agreement that are not made on or
before the thirty (30) days following the applicable due date shall bear interest at a rate equal to the lesser of (i) two percent (2%) per annum above the Prime Rate, as reported in the print edition of The Wall Street Journal, Eastern
Edition, on the date such payment was due or, if unavailable, on the latest date prior to the payment due date on which such rate is available, and (ii) the maximum rate permitted under Applicable Law, calculated on a daily basis, based on the
actual number of days elapsed from the payment due date to the date of actual payment. 
 3.9 Submission of Invoices. Merck shall
submit all invoices electronically to Organon. Notwithstanding the foregoing, Organon and Merck may mutually agree: (i) to change the vehicle for electronic submission; or (ii) that Merck submit a hard copy of such invoices. 

3.10 Interim Services Agreement. To the extent any Service or Expense Activity is provided hereunder by an Affiliate of Merck to an
Affiliate of Organon within the same country, any applicable Service Fee or Expenses will be invoiced and payable in accordance with the applicable local Interim Services Agreement. Following the Effective Date, local Interim Services Agreements
will remain effective only for invoicing such Service Fees or Expenses and any other terms and conditions in this Agreement supersede those in any local Interim Services Agreement. 

3.11 No Double Counting. Notwithstanding anything in this Agreement to the contrary, the Parties acknowledge and agree that Organon will
not be charged more than once for the same service, activity, function or Expense that is performed or incurred by Merck or its Affiliates or Third Parties pursuant to this Agreement to the extent that Organon or its Affiliates are bearing the
charges for such service, activity, function or Expense pursuant to another Transaction Document. 
 4. Term and Termination. 

4.1 Term. This Agreement will commence on the Effective Date and end on the earlier of (i) the date on which Merck’s
obligation to perform any Services under this Agreement ceases due to their expiration or termination in full in accordance with Section 4.2 or Section 4.3.3 or (ii) the date on which this Agreement is terminated pursuant to
Section 4.3.1 or 4.3.2 (the “Term”). 

  
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 4.2 Duration of Services. 

4.2.1 General Duration. Each Service to be provided by Merck under this Agreement shall (i) commence to be provided from and after
the Effective Date, unless a different commencement date is specified in the applicable section of the Transition Services Schedule, and (ii) terminate (a) on the end date specified with respect to such Service in the applicable section of the
Transition Services Schedule or the end date of any extension of such specified end date agreed to by the Parties in accordance with Section 4.2.2, or (b) on the date such Service is terminated in accordance with Section 4.3.1 or on
the date such Service is terminated by the Transition Managers in accordance with Section 4.3.3, (such end date, the “Service Termination Date”). The commencement date of any Service (and the corresponding Service Fee for such)
that is tied to the Exit Date for an IOM Market or Deferred Market will be adjusted accordingly if such applicable Exit Date is changed. 

4.2.2 Extension. 
 (i)
The Service Termination Date specified with respect to a Service or Ad Hoc Service in the applicable section of the Transition Services Schedule can be extended by the mutual written agreement of the Transition Managers in accordance with this
Section 4.2.2 (including the markups noted for extended durations in Schedule 2) and Section 5. If Organon desires to request the extension of a Service Termination Date, the Organon Transition Manager shall, no later than ninety
(90) days prior to the Service Termination Date (or such greater period as set forth in the applicable Section of the Transition Services Schedule or as necessary to comply with any Applicable Law before implementation of an extension, while
providing for the thirty (30) day period for response from Merck subsequent to such a request being made, and time to reach agreement on extending the Service), provide a written request thereof to the Merck Transition Manager setting forth the
desired extended Service Termination Date. Notwithstanding the ninety (90) day and thirty (30) day references in Sections 4.2.2(i) and 4.2.2(ii), respectively, if a Service with a Service Termination Date tied to a Marketing Authorization
Transfer Date (as defined in the Regulatory Agreement) needs to be extended due to a change in such Marketing Authorization Transfer Date due to an action or inaction by a Governmental Authority, and not as a result of the action or inaction of
Organon, the Parties will use Commercially Reasonable Efforts to assess and make final determination pursuant to this Section 4.2.2 on whether the duration of such Service shall be extended, the new Service Termination Date, and the applicable
Service Fee; provided that such new Service Termination Date shall not fall after Merck’s obligation to support transfer of such Transferred Marketing Authorization (as defined in the Regulatory Agreement) ceases in accordance with the
Regulatory Agreement. 
 (ii) Within thirty (30) days following the receipt of such extension request, the Merck Transition Manager
shall provide the Organon Transition Manager with a written response to such request setting forth the applicable Service Fee for such extended Services (which Service Fee shall be calculated in accordance with the principles set forth on
Schedule 2) and an assessment as to whether the requested Service Termination Date can be achieved. Following receipt by the Organon Transition Manager of the Merck Transition Manager’s response to the extension request, the
applicable Service Termination Date and the Service Fee (which shall be calculated in accordance with the principles set forth on Schedule 2) shall be as mutually agreed upon in writing by the Transition Managers in accordance with
Section 5. Upon agreement of the Transition Managers in accordance with this Section 4.2.2 and Section 5, the Transition Services Schedule and the Service Fees Schedule shall be amended or updated by the Transition Managers to change
the applicable Service Termination Date and to reflect the Service Fee applicable to such extended Services. 

  
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 4.3 Termination. 

4.3.1 Material Breach. If either Party materially breaches this Agreement (or a given Schedule to the extent that the material breach
relates solely to such Schedule), the non-breaching Party may give written notice to the other Party, specifying the nature of the material breach and, if such material breach is not remedied within thirty
(30) calendar days of receipt of such written notice (provided, however, that the cure period shall be suspended during any time that a Party seeks resolution of a dispute as to whether an alleged material breach occurred pursuant to any
dispute resolution mechanisms under this Agreement), then the non-breaching Party shall have the right, in its sole discretion, to immediately terminate this Agreement upon written notice to the breaching
Party. Notwithstanding the foregoing, if such material breach relates only to a given Service, then the non-breaching Party shall only have the right to terminate the applicable Service to which such material
breach relates and this Agreement, and all other Services shall not be affected by such termination. 
 4.3.2 Bankruptcy. This
Agreement may be terminated by written notice given by a Party upon the occurrence of any of the following with respect the other Party: (i) such other Party becomes insolvent, or (ii) voluntary or involuntary proceedings by or against
such other Party are instituted in bankruptcy or under any insolvency law, which proceedings, if involuntary, shall not have been dismissed within ninety (90) days after the date of filing, or (iii) a receiver or custodian is appointed for
such other Party, or proceedings are instituted by or against such other Party for corporate reorganization or the dissolution of such other Party, which proceedings, if involuntary, shall not have been dismissed within ninety (90) days after
the date of filing, or (iv) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors, or substantially all of the assets of such other Party are seized or attached and not released within ninety
(90) days thereafter. 
 4.3.3 Early Termination. Notwithstanding anything in this Agreement to the contrary, Organon shall be
entitled to request the termination of any Service at its convenience, in whole or in part (but only to the extent that such termination in part would not jeopardize the provision of any remaining parts of such Service), at any time (without
terminating any other Service) prior to the applicable Service Termination Date, by the Organon Transition Manager giving the Merck Transition Manager ninety (90) days (or such greater period as set forth in the applicable Section of the
Transition Services Schedule or as necessary to comply with any Applicable Law, while providing for the thirty (30) day period for response from Merck subsequent to such a request being made, and time to reach agreement on terminating the
Service) prior written request (the “Service Termination Notice”), and upon receipt by the Merck Transition Manager of the Service Termination Notice from the Organon Transition Manager, the Merck Transition Manager shall provide a
written response to such Service Termination Notice within thirty (30) days of receipt thereof, including any additional Expenses associated with such early termination, and, if the Merck Transition Manager accepts the request for termination
set forth therein, the Transition Managers may mutually agree in writing to terminate such Service, including the new Service Termination Date and any additional Expenses to be charged to Organon, in accordance with Section 5; provided that
(i) in the event of any such termination of a Service in whole, Organon shall continue to be liable for paying the Service Fee related to any such terminated Service until the end of the applicable Calendar Quarter in which the newly agreed
upon end date of such Service falls (and such Service Fee shall no longer be payable in the subsequent Calendar Quarter), as well 

  
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 as all other non-cancelable Expenses (including any costs or
penalties related to Third Party Agreements, wind-down costs, minimum volume make-up fees and any other costs associated with the Service that Merck cannot eliminate prior to the previously planned Service
Termination Date, including unamortized costs that Merck previously incurred or is required to pay) incurred by Merck or any of its Affiliates in connection with any early terminated Service, and (ii) in the event of any such termination of a
Service in part, Organon shall continue to be liable for paying the entire Service Fee related to such Service, as well as all other Expenses incurred by Merck or any of its Affiliates in connection with such Service, until such Service is fully
terminated or expired hereunder. 
 4.4 Effect of Termination of Services; Survival. In the event of any termination with respect to
one or more, but less than all, of the Services, this Agreement will continue in full force and effect with respect to any Services not so terminated and, as applicable, any Expenses payable pursuant to Section 3.2. Upon the termination of any
or all of the Services, Merck will cease, or cause its applicable Affiliates or Subcontractors to cease, providing the terminated Services. Upon each such termination, Organon will pay to Merck all Service Fees and Expenses accrued and incurred
through the applicable Service Termination Date related to such terminated Service included in the subsequent quarterly invoice provided by Merck to Organon with respect to such Service and Expenses in accordance with Section 3.3 and
Section 4.3. The terms, provisions, representations and warranties contained in this Agreement that by their sense and context are intended to survive the performance thereof by either Party or both Parties hereunder (including in Sections
2.3.3, 3, 7, 8, 9, 11 and 12, shall so survive the completion of performance, expiration or termination of this Agreement (or a given Service, as applicable). Upon the expiration of the Term or if this Agreement is terminated with respect to all of
the Services pursuant to Section 4.3, Merck shall provide Organon a final invoice setting forth any and all accrued and unpaid Service Fees and Expenses related to the Services, including in accordance with Section 4.3, and Organon shall
promptly pay such amounts set forth on such invoice. 
 5. Governance. 

5.1 Designation of Transition Managers. Merck and Organon will each assign one person to act as that Party’s Transition Manager for
the Services and Expenses. The Transition Managers will (i) represent and act for their respective Party for matters related to the Services and Expenses, and (ii) meet and/or confer on a regular basis (at mutually agreed times and
locations) to review the activities under this Agreement (including progress with respect to the TSA Exits) and to discuss the status and progress of such activities. Either party may change its Transition Manager whenever it considers it
appropriate and, in any such case, shall advise the other Party of such changes accordingly. In addition to the Transition Managers, each Party shall designate a functional representative for each function that is providing or receiving, as the case
may be, a Service hereunder while such applicable Service is being provided and received. 

  
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 5.2 Responsibilities of Transition Managers. Without limiting the generality of
Section 5.1, during the Term, the Transition Managers shall serve as their respective Party’s primary contact for the other Party to manage and coordinate the provision of the Services and Expense Activities and payment of Service Fees and
Expenses provided hereunder and the performance of the Parties’ other obligations hereunder, including any associated exchange of Information and transition of responsibilities related to the Services and Expense Activities. The Transition
Managers shall be responsible for ensuring that, during the Term, both Parties appropriately prepare for the transition of responsibilities associated with the TSA Exits and that the Parties understand the tasks necessary to accomplish a smooth
transition. 
 5.3 Decisions of Transition Managers. The Transition Managers shall promptly meet to discuss such matters submitted or
communicated to them by the executives responsible for the transition management, including the completion of any TSA Exit and any amendment, supplement or modification of or to the Transition Services Schedule or the Service Fees Schedule, and
reasonably and in good faith cooperate to reach agreement on mutually acceptable terms. All changes to the Transition Services Schedule or the Service Fees Schedule shall be documented in writing in either a document, amendment or other instrument
or in meeting minutes and mutually agreed upon by the Transition Managers. Notwithstanding anything to the contrary set forth herein, each Transition Manager can only make decisions and agreements under this Agreement upon approval of, and receipt
of the requisite authority to make such decision or enter into such agreement from, such Party’s established processes for such approval or authorization. 

5.4 Issues Resolution. The Transition Managers and/or functional representatives will work together to resolve issues or potential
disputes relating to this Agreement, with the intent of averting the escalation of such issues or potential disputes. Should escalation be required, the Transition Managers shall meet first with the Transition Management Office (TMO) Leads (as
defined in the Separation and Distribution Agreement). If not resolved the TMO Leads will meet with executives from each Party to resolve the escalation issue.

6. Transition Service Responsibilities. 

6.1 Responsibilities of Merck. Subject to Sections 6.2 and 6.3 and the applicable section of the Transition Services Schedule, Merck
shall use Commercially Reasonable Efforts to provide the Services, or cause the Services to be provided. 
 6.2 Responsibilities of
Organon. 
 6.2.1 Organon will provide Merck with (i) such access to Organon’s facilities as is, in Merck’s reasonable
good faith judgment, necessary for Merck or any of its Affiliates to perform the Services or Expense Activities required hereunder; (ii) such Information as is, in Merck’s reasonable good faith judgment, necessary for Merck or any of its
Affiliates to perform the Services or Expense Activities required hereunder; and (iii) such reasonable access to resources and timely decisions, as reasonably requested by Merck in good faith from time to time, in order to permit Merck or any
of its Affiliates to perform the Services and or Expense Activities required hereunder. 
 6.2.2 If Organon fails to perform, or procure the
performance of, any of its obligations under this Section 6.2 and such failure impairs the provision of such element of the Services or Expense Activities, Merck shall not be obliged to provide, or procure the provision of, such element of the
Services or Expense Activities; provided that Merck shall notify Organon as soon as reasonably practicable upon the occurrence of such failure. 

  
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 6.3 Mutual Responsibilities. The Parties will use Commercially Reasonable Efforts to
cooperate with each other in all matters relating to the provision and receipt of Services and to Expenses. Such cooperation will include (i) Merck designating a Merck Transition Manager for purposes of this Agreement, and Organon designating
an Organon Transition Manager for purposes of this Agreement; (ii) exchanging information relevant to the performance of the Services to be provided hereunder and to Expenses; and (iii) good faith efforts to mitigate problems with the work
environment interfering with the performance of the Services and or Expense Activities required hereunder. 
 6.4 Compliance. Each
Party shall observe and comply with, and give all notices required by, Applicable Law and Industry Codes. Each Party shall promptly notify the other Party if it becomes aware of any noncompliance with Applicable Law or Industry Codes in connection
with its activities under this Agreement, and shall take all appropriate action necessary to ensure compliance with Applicable Law and Industry Codes in connection with its activities under this Agreement. All activities performed and Services
provided hereunder shall be performed in accordance with the relevant provisions of the other Transaction Documents, including the Regulatory Agreement, governing compliance. Notwithstanding the foregoing, nothing in this Agreement shall be
construed as a representation or warranty by Merck that any Service, Expense Activity or other items provided in connection therewith is sufficient to satisfy Organon’s obligations under Applicable Laws or Industry Codes. 

6.5 Security. 
 6.5.1 If
either Party is given access to the other Party’s (or its Affiliate’s) computer systems or software (collectively, the “Systems”) or physical facilities in connection with the performance or receipt of the Services or
Expense Activities, such Party shall comply with all of the other Party’s reasonable policies, procedures and requirements in relation to Systems or physical facilities (collectively, “Security Regulations”) and will not tamper
with, compromise, attempt to circumvent or circumvent any security or audit measures employed by such other Party. In the event of any conflict between this Agreement and any Security Regulations, this Agreement will govern. Each Party shall access
and use only those Systems of the other Party for which it has been granted the right to access and use, and only to the extent reasonably necessary in connection with the provision or receipt, as applicable, of the Services and Expense Activities.
Each Party shall be responsible for its employees’ compliance with the confidentiality provisions of this Agreement in connection with such access, including access to comingled or sensitive Information. 

6.5.2 Each Party will ensure that only those of its personnel who are specifically authorized to have access to the Systems or physical
facilities of the other Party (or its Affiliates) gain such access, and to prevent unauthorized access, use, destruction, alteration or loss of Information or other property contained therein, including notifying its personnel of the restrictions
set forth in this Agreement and of the Security Regulations. 

  
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 6.5.3 If, at any time, either Party determines that (i) any of its personnel has
sought to circumvent, or has circumvented, the Security Regulations of the other Party, (ii) any unauthorized personnel of such Party has accessed the Systems or physical facilities of the other Party, or (iii) any of the personnel of such
Party has engaged in activities that may lead or leads to the unauthorized access, use, destruction, alteration or loss of Information or software, such Party shall immediately terminate any such personnel’s access to the Systems or physical
facilities of the other Party and immediately notify the other Party. In addition, each Party shall have the right to deny the personnel of the other Party access to any Systems or physical facilities upon written notice to the other Party in the
event that such Party reasonably believes that such personnel have engaged in any of the activities set forth above in this Section 6.5 or otherwise pose a security concern. Each Party will cooperate with the other Party in investigating any
apparent unauthorized access to the Systems or facilities of the other Party. 
 6.6 TSA Exit. 

6.6.1 The Parties acknowledge and agree that the Services to be provided hereunder are transitional in nature and are intended to provide
Organon with reasonable time to develop the internal resources and capacities (or to arrange for Third Parties) to provide such Services. Accordingly, at all times from and after the Effective Date, Organon shall use Commercially Reasonable Efforts
to make or obtain approvals, permits or licenses, implement any necessary systems, hire and train required employees or contractors, put in place agreements with Third Parties, and take, or cause to be taken, any and all other actions necessary or
advisable so as to render receipt of the Services from Merck no longer necessary. 
 6.6.2 In the event and to the extent a plan for each
TSA Exit has not been developed or finalized by Organon prior to the Effective Date, then, unless the timing is otherwise set forth in the applicable section of the Transition Services Schedule, no later than six (6) months prior to each
planned Service Termination Date in the Transition Services Schedule, Organon shall prepare a plan for the TSA Exit, which plan shall be provided to Merck for its review and, for any TSA Exit plan that includes requested support from Merck, its
consent. Organon will have the sole, full responsibility for planning and, unless otherwise agreed to by the Parties in accordance with Section 3.2.9, carrying out the TSA Exits prior to the expiration of the applicable Service Termination Date
specified in the applicable section of the Transition Services Schedule, and in no event will Merck be required to transfer or assign any contracts or agreements to Organon in connection with the expiration or termination of any Service or
otherwise. 
 6.6.3 Organon functional representatives shall periodically and on a regularly scheduled basis, at minimum quarterly unless
otherwise agreed by the Parties, deliver to Merck functional representatives a detailed written work plan describing its progress with respect to the TSA Exits and such plan and the progress against such plan shall be discussed by the functional
representatives and/or Transition Managers in accordance with Section 5. Such written work plan shall address the following with respect to each of the Services: (i) phases of implementation, if applicable; (ii) any applicable
milestones and expected Service Termination Date for a Service; and (iii) expected Merck involvement, as applicable and subject to Section 3.2.9. 

  
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 7. Confidentiality; Data Privacy. 

7.1 Disclosure of Confidential Information. Each Party hereto: (i) will retain in strict confidence the terms and conditions of
this Agreement (including the nature of the services provided) and the Confidential Information of the other Party; and (ii) will not disclose the terms and conditions of this Agreement or the Confidential Information of the other Party to any
other Third Party, unless otherwise required by Applicable Law or judicial or administrative process (in which case the provisions of Section 7.2.2 shall apply), without the other Party’s prior written consent. Notwithstanding the
foregoing, each Party (and its respective Affiliates) shall be permitted to disclose any terms of this Agreement to the extent required in connection with its filings with the Securities and Exchange Commission or in compliance with the rules of any
securities or listing requirement. 
 7.2 Permitted Disclosures. 

7.2.1 Notwithstanding Section 7.1, each Party shall be permitted to disclose Confidential Information of the other Party, if such
Confidential Information: 
 (i) is disclosed by a Party (or its Affiliates) to a Governmental Authority in order to maintain or obtain
regulatory approval to manufacture and/or market Organon Product, but such disclosure may be only to the extent reasonably necessary to obtain such approvals; 

(ii) is disclosed by the receiving Party (or its Affiliates) to agent(s), consultant(s), and/or other Third Parties who are performing
obligations of the receiving Party or exercising rights granted to the receiving Party under this Agreement on the condition that such Third Parties agree to be bound by confidentiality and non-use obligations
that substantially are no less stringent than those confidentiality and non-use provisions contained in this Agreement; 

(iii) is deemed necessary by counsel to the receiving Party to be disclosed to such Party’s attorneys, independent accountants or
financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the receiving Party, on the condition that such attorneys, independent accountants and financial advisors agree to
be bound by confidentiality and non-use obligations that substantially are no less stringent than those confidentiality and non-use provisions contained in this
Agreement; or 
 (iv) is disclosed in connection with a merger or acquisition of a given Party (or its Affiliate) or a divestiture of a
portion of such Party’s business related to this Agreement (or a given Organon Product, as applicable), such Party shall have the further right to disclose the material financial terms of this Agreement (or such Organon Product, as applicable,
to Third Parties involved in such merger or acquisition provided that such Third Parties agree to be bound by confidentiality and non-use obligations that substantially are no less stringent than those
confidentiality and non-use provisions contained in this Agreement. 
 7.2.2 In addition, if a Party
is required by judicial or administrative process or Applicable Law to disclose Confidential Information that is subject to the non-disclosure provisions of Section 7.1, such Party shall promptly inform
the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process or as
required by Applicable Law shall remain otherwise subject to the confidentiality and non-use provisions of Section 7.1, and the Party disclosing Confidential Information pursuant to law or court order or
as required by Applicable Law shall take all steps reasonably necessary, including obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information. 

  
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 7.3 Equitable Relief with respect to Disclosure of Confidential Information. The
Parties hereto acknowledge that: (i) it would be impossible to measure the damages that would be suffered by the other Party if a Party failed to comply with this Section 7; and (ii) in the event of any such failure, there might not
be adequate remedy at law. Therefore, each Party hereto shall be entitled, in addition to any other rights or remedies that it may have, to obtain specific performance by the other Party of the obligations of this Section 7, to obtain immediate
injunctive relief without having to post a bond. Neither Party hereto will urge, as a defense to any proceeding for such specific performance or injunctive relief, that the other Party has an adequate remedy at law. 

7.4 Return of Confidential Information. Upon the written request of the disclosing Party, the receiving Party shall immediately either
return to the disclosing Party, or destroy, all Confidential Information of the disclosing Party, in accordance with the instructions of the disclosing Party, including all notes, summaries, and translations that have been made regarding such
Confidential Information, and all copies of the foregoing. In the event destruction is requested by the disclosing Party, the receiving Party shall certify such destruction in writing. Notwithstanding the foregoing, the receiving Party may retain a
copy for purposes of exercising any licenses under this Agreement (including any licenses that survive the termination or expiration of this Agreement) and may archive one (1) copy of Confidential Information for purposes of demonstrating its
compliance with this Agreement, subject to confidentiality requirements of this Agreement. 
 7.5 Data Privacy. 

7.5.1 Interpretation. In this Section 7.5, (i) “Data Protection Law” means, all applicable laws, rules and
regulations (ii) “Data Subject”, “Personal Data”, “Personal Data Breach” and “Processing” will be construed in accordance with the EU General Data Protection Regulation 2016/679,
and (iii) “Covered Personal Data” means Personal Data provided to or made available by Organon to Merck in order for Organon to receive the Services and Expense Activities. 

7.5.2 Description of Processing. The Processing of Covered Personal Data shall be for the duration of this Agreement, for the purpose
of providing the Services and or Expense Activities, and include the following categories of Personal Data of current and former employees (including dependents), customers, suppliers, healthcare professionals, researchers, and business partners of
Organon: (i) name and contact information; (ii) personal characteristics (e.g., gender, marital status, citizenship, passport number); (iii) financial data (including compensation details for employees, and transfers of value to healthcare
professionals); (iv) employment history and status, including job applications and resumes of unsuccessful candidates; (v) information relating to family members and dependents; (vi) information related to benefits administration;
(vii) information related to performing a clinical trial shared with regulatory authorities; and (viii) special categories of data such as health and disability details, religion/ethnicity details, criminal allegation/defense details. 

  
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 7.5.3 Organon’s Obligations. Organon shall ensure that at all times,
(i) Organon has a lawful basis to provide or make available Covered Personal Data to Merck, and (ii) Organon’s instructions to Merck in respect of Covered Personal Data comply with Applicable Law. 

7.5.4 Additional Processing Terms. When Processing Covered Personal Data on behalf of Organon, Merck shall use Commercially Reasonable
Efforts to: (i) only process Covered Personal Data on Organon’s written instructions unless required otherwise by Applicable Law; (ii) ensure that Merck personnel who have access to Covered Personal Data are subject to confidentiality
obligations; (iii) implement and maintain technical and organizational measures designed to prevent a Personal Data Breach, and upon becoming aware of substantiated Personal Data Breach, Merck shall notify Organon without undue delay;
(iv) taking into account the nature of the processing, at Organon’s cost and expense, assist Organon insofar as this is possible, to meet its obligations under Data Protection Law; and (v) upon request and at Organon’s cost and
expense, make available information reasonably requested by Organon to demonstrate compliance with this Section 7.5, and allow for Organon to request an audit or inspection. 

7.5.5 Cross-border Transfers. To the extent required by Applicable Law, the Standard Contractual Clauses in Schedule 6 shall
apply to any transfer between Organon and Merck of Covered Personal Data from one jurisdiction to another (“International Transfer”). Without limiting Organon’s obligations under this Agreement, Organon shall, and shall procure
that each Organon Affiliate shall, do all things reasonably necessary to ensure that any International Transfer complies with Applicable Law, including entering into any subsequent agreement(s) with Merck or a Merck Affiliate. In the event of any
conflict or inconsistency between the Standard Contractual Clauses in Schedule 6, if applicable, and this Agreement, the Standard Contractual Clauses shall prevail. 

8. General Representations and Warranties; Disclaimer. 

8.1 General Representations and Warranties. Each of Organon and Merck represents, warrants, covenants and agrees that, at all times
during the Term, (i) it is a limited liability company duly organized and validly existing and in good standing under the laws of its jurisdiction of organization, (ii) it is qualified or licensed to do business and in good standing in
every jurisdiction where such qualification or licensing is required, (iii) it has the corporate power and authority to execute, deliver and perform its obligations under this Agreement, and the execution, delivery and performance of this
Agreement by it has been duly authorized by all necessary corporate action, (iv) this Agreement has been duly executed and delivered by it, and (v) this Agreement constitutes the valid and binding obligations of it, enforceable against it
in accordance with its terms except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting creditor’s rights generally, or general principles of equity. 

8.2 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES IN CONNECTION
WITH THE SERVICES OR OTHERWISE, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT, ALL OF WHICH ARE HEREBY SPECIFICALLY AND EXPRESSLY EXCLUDED AND

  
 33 

 DISCLAIMED. FOR THE AVOIDANCE OF DOUBT, NOTHING CONTAINED IN THIS SECTION 8.2 SHALL OPERATE TO LIMIT OR
INVALIDATE ANY REPRESENTATION OR WARRANTY CONTAINED IN THE SEPARATION AND DISTRIBUTION AGREEMENT. NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, ALL THIRD PARTY SOFTWARE, SERVICES AND EXPENSE ACTIVITIES ARE PROVIDED BY MERCK “AS IS”
WITHOUT ANY WARRANTY OF ANY KIND OTHER THAN THAT WHICH CAN BE PASSED THROUGH FROM THE APPLICABLE THIRD PARTY LICENSOR. 
 9.
Indemnification.  
 9.1 By Organon. In addition to any other available remedies, Organon hereby agrees to indemnify,
defend and hold harmless Merck and its Affiliates, and their respective officers, directors, employees, shareholders, members, partners, agents, representatives, successors and assigns (collectively, “Merck Indemnitees”) from and
against all Third Party Damages based on a Third Party Claim imposed on, incurred by or asserted against any of Merck Indemnitees arising out of or relating to (i) Merck’s provision of Services or Expense Activities to Organon in
accordance with the terms of this Agreement and that are not proximately caused by the gross negligence, fraud or willful misconduct of Merck or its Affiliates or Subcontractors, or (ii) failure by Organon to comply with its obligations under
this Agreement. 
 9.2 Procedure. Merck will notify Organon of any demand by Merck for indemnification from Organon that is based on
any Third Party Claim and provide Organon with copies of any papers served on Merck relating to that Third Party Claim, but Merck’s failure to provide or delay in providing that notice or those copies will not release Organon from its
obligations under Section 9.1, except to the extent that the failure or delay materially prejudices Organon. Organon has the exclusive right to conduct the defense of any such Third Party Claim and any negotiations for its settlement, except
that (i) Organon may not enter into any compromise or settlement unless Merck consents to such compromise or settlement, which consent shall not be unreasonably withheld or delayed, and which consent shall be deemed given with respect to any
compromise or settlement relating solely to the payment of money damages if such compromise or settlement includes as an unconditional term thereof, the giving by each claimant or plaintiff to the Merck Indemnitees of a release from all liability in
respect of such claim, (ii) Merck may participate at its expense in Organon’s defense of or settlement negotiations for any Third Party Claim with counsel of Merck’s own selection, and (iii) Merck may, at its option and
Organon’s expense, and on prior written notice to Organon, conduct the defense of and any settlement negotiations for any Third Party Claim in place of Organon if Organon fails to promptly defend the Third Party Claim as required in this
Article 9. At Merck’s request and Organon’s expense, and in addition to Organon’s other obligations under this Agreement, Organon shall assist Merck with the defense of any Third Party Claim for which Merck conducts the defense under
this Article 9. 
 9.3 Damages. EXCEPT FOR A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 7, IN NO EVENT SHALL
EITHER PARTY OR ITS AFFILIATES OR ITS OR THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES OR ITS OR THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS FOR ANY INDIRECT OR CONSEQUENTIAL
DAMAGES OR INDIRECT OR CONSEQUENTIAL 

  
 34 

 
LOSSES, OR FOR ANY LOSS OF REVENUES OR LOST PROFITS (WHETHER DIRECT OR INDIRECT), IN EACH CASE OF ANY KIND, NATURE OR DESCRIPTION WHATSOEVER SUFFERED OR INCURRED BY SUCH PARTY ARISING UNDER OR IN
CONNECTION WITH THIS AGREEMENT OR AS A RESULT OF ANY ACTIVITIES HEREUNDER, REGARDLESS OF WHETHER ARISING FROM BREACH OF CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, EVEN IF SUCH PARTY IS ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE
OR IF SUCH LOSS OR DAMAGE COULD HAVE BEEN REASONABLY FORESEEN. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.3 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OF MERCK OR OBLIGATIONS OF ORGANON WITH RESPECT TO ANY
THIRD PARTY CLAIMS UNDER SECTION 9.1. 
 9.4 Liability Cap. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, THE TOTAL AND
AGGREGATE LIABILITY OF MERCK (AND ITS AFFILIATES) ARISING OUT OF, OR OTHERWISE IN CONNECTION WITH, THIS AGREEMENT (INCLUDING BREACH OF CONTRACT, TORT, INDEMNITY, OR OTHERWISE) SHALL NOT EXCEED SIX MILLION DOLLARS ($6,000,000). 

10. Audit Rights. 

10.1 Merck shall, and shall cause its Affiliates to, prepare and maintain the Records and any records relating to the payment of Expenses
pursuant to Section 3, which shall be open to inspection and subject to audit and/or reproduction, during normal working hours, by an independent accounting firm or other appropriate Third Party representative selected by Organon, and
reasonably acceptable to Merck (including entering into a reasonably acceptable confidentiality agreement), for evaluation and verification of the provision of each Service, but, for the avoidance of doubt, not the Service Fee or associated cost of
each Service, hereunder by Merck in accordance with the applicable section of the Transition Services Schedule (excluding the Service Fee) with respect to the Records and evaluation and verification of the accuracy of any Expenses paid pursuant to
Section 3; provided, however, that such right to conduct such audits and inspections and/or reproduction shall not occur (i) more frequently than one (1) time per Calendar Year, and (ii) with respect to such audits and
inspections relating to any Expenses paid pursuant to Section 3, no later than the Calendar Year following the Calendar Year in which such Expense was paid, unless Organon has reasonable cause to believe that Merck is not complying with this
Agreement. 
 10.2 The accounting firm or other Third Party representative shall have access to Merck’s facilities and shall be provided
adequate and appropriate work space, in order to conduct audits in compliance with this Section 10.1. Organon shall give Merck at least forty-five (45) days’ prior notice of intent to audit. The accounting firm or other Third Party
representative shall have access to the Records and any records relating to the payment of Expenses pursuant to Section 3 and Merck shall preserve the Records and any records relating to the payment of Expenses pursuant to Section 3 for a
period of two (2) years following the date the Records and any records relating to the payment of Expenses pursuant to Section 3 were created, or for such longer period as may be required by Applicable Laws.

  
 35 

 10.3 The right to audit and/or inspect the Records pursuant to this Section 10 shall
terminate with respect to each Service to be provided by Merck under this Agreement on the applicable Service Termination Date. The right to audit and/or inspect any records relating to the payment of Expenses pursuant to Section 3 pursuant to
this Section 10 shall terminate with respect to each such Expense at the end of the Calendar Year following the Calendar Year in which such Expense was paid by Organon to Merck. 

10.4 If an audit, inspection or examination of any records relating to the payment of Expenses pursuant to Section 3 conducted in
accordance with this Section 10 discloses overcharges (of any nature) by Merck to Organon or undercharges (of any nature), any undisputed adjustments and/or payments to Organon shall be made by Merck or Organon, as applicable, within a
reasonable amount of time not to exceed ninety (90) days from presentation of Organon’s findings to Merck. 
 10.5 Organon shall
bear all costs and expenses incurred by Organon in connection with any such audit or inspection; provided, however, that if any such audit or inspection correctly identifies any overcharges (of any nature) that are the fault of Merck in excess of
the greater of (i) five percent (5%) of the amount actually payable by Organon and (ii) $500,000, then in such case Merck shall reimburse Organon for all reasonable
out-of-pocket costs incurred by Organon in connection with such audit or inspection. 

11. Financial Controls. 

11.1 During the Term, and until financial statements have been filed for the fiscal year following the end of the Term, Organon shall have the
right once (and only once) per each fiscal quarter of Merck, subject to mutual agreement of an annual audit calendar, agreement by either party not to be unreasonably withheld at its own cost and expense, itself and/or through a designated third
party auditor(s) selected by Organon, and reasonably acceptable to Merck, upon at least thirty (30) days advance written notice to Merck or any of its Affiliates and during Merck’s regular business hours and subject to Merck’s
reasonable policies and procedures, to audit and inspect Information and processes and information technology systems, including internal audit reports and the audit reports of Merck’s accounting firm, solely as such Information and reports
relate to the Services and Expense Activities hereunder, solely (i) as necessary for Organon and its Affiliates to verify the accuracy of internal controls over information technology, reporting of financial data and related processes employed
in connection with verifying compliance with Section 404 of the Sarbanes-Oxley Act of 2002, or (ii) as required to enable Organon and its Affiliates and their respective accounting firm to complete an audit or review of their respective
financial records and data; provided that, in each case, (x) such access shall not unreasonably interfere with any of the business or operations of Merck or any of its Affiliates or any audit or review of the consolidated financial statements
of Merck or any of its Affiliates for any fiscal year or fiscal quarter and (y) in the event that Merck determines that providing such access would violate any Applicable Law or agreement or waive any attorney-client or similar privilege, then
Merck and Organon shall use commercially reasonable efforts to permit such access in a manner that avoids any such consequence. 

  
 36 

 11.2 Organon shall be responsible for its employees’ and representatives’
compliance with the confidentiality and Security provisions of this Agreement in connection with any such access to such Information. Any control remediations resulting from Organon’s audit of such Information pursuant to this
Section 11 that are applicable to Merck shall not be charged to Organon; provided, however, that if there are differences in materiality that require additional work for Merck to maintain controls for Organon at a lower level of precision, any
costs incurred by Merck in connection with such maintenance shall be charged to Organon as Expenses, which shall be calculated in accordance with the principles set forth on Schedule 2, or, if applicable, such additional work will treated as an
Additional Service or a change in scope to an existing Service. 
 12. Miscellaneous. 

12.1 Independent Contractor. 

12.1.1 In the performance of Merck’s obligations under this Agreement, Merck shall at all times act as and be deemed an independent
contractor. Nothing in this Agreement shall be construed to render Merck or any of its employees, agents, or officers, as an employee, joint venture, agent, or partner of Organon. Merck is not authorized to assume or create any obligations or
responsibilities, express or implied, on behalf of or in the name of Organon. It is understood that the employees, methods, facilities, and equipment of Merck shall at all times be under Merck’s exclusive direction and control. 

12.1.2 In the performance of Organon’s obligations under this Agreement, Organon shall at all times act as and be deemed an independent
contractor. Nothing in this Agreement shall be construed to render Organon or any of its employees, agents, or officers, as an employee, joint venture, agent, or partner of Merck. Organon is not authorized to assume or create any obligations or
responsibilities, express or implied, on behalf of or in the name of Merck. It is understood that the employees, methods, facilities, and equipment of Organon shall at all times be under Organon’s exclusive direction and control. 

12.2 Force Majeure. No Party shall be liable for a failure or delay in performing any of its obligations under this Agreement (except
for the payment of money) if, but only to the extent that, such failure or delay is due to causes beyond the reasonable control of the affected Party, including: (i) acts of God; (ii) fire or explosion (except to the extent caused by the
negligence or willful misconduct of the affected Party); (iii) unusually severe weather; (iv) war, invasion, riot or other civil unrest; (v) governmental laws, orders, restrictions, actions, embargoes, or blockages; (vi) national or
regional emergency; (vii) injunctions, strikes, lockouts, labor trouble, or other industrial disturbances; and (viii) shortage of supply of commodity materials on a global basis (each, a “Force Majeure Event”); provided
that the Party affected shall promptly notify the other of the Force Majeure Event and shall exert reasonable efforts to eliminate, cure, or overcome any such causes and to resume performance of its obligations as soon as practicable. 

12.3 Governing Law; Dispute Resolution. 

12.3.1 This Agreement shall be construed and governed under and in accordance with the laws of the State of New York, without giving effect to
the principle of conflict of laws thereof. 

  
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 12.3.2 All disputes between the Parties that may arise under this Agreement shall be
resolved in accordance with the dispute resolution process applicable to such disputes set forth in the Separation and Distribution Agreement. 

12.4 No Waiver. Any Party’s failure to enforce any of the terms or conditions herein or to exercise any right or privilege pursuant
hereto, or any Party’s waiver of any breach under this Agreement, shall not be construed to be a waiver of any other terms, conditions, or privileges, whether of a similar or different type. 

12.5 Assignment. 
 12.5.1
Neither this Agreement nor any of the Services or Expense Activities hereunder may be assigned, in whole or in part, whether by operation of law or otherwise (however structured), without the prior written consent of the other Party; provided,
however, that 
 (i) a Party shall have the right, without the prior consent of the other Party, to assign this Agreement, in whole or in
part, to any Affiliate of such Party; and 
 (ii) a Party shall have the right, without the prior consent of the other Party, to assign this
Agreement, in whole, to any Third Party in connection with a sale of all or substantially all of the assets of such Party to which this Agreement relates whether by merger, sale of stock, sale of assets or other similar transaction (including by
operation of Applicable Law), in each case upon prior written notice to the other Party. 
 12.5.2 Any permitted assignee shall assume all
obligations of its assignor under this Agreement; provided, however, that in the event of an assignment to an Affiliate, the assignor Party shall remain as principal obligor for all or any obligations and liabilities assigned to such Affiliate under
the terms of this Agreement. No assignment shall relieve any Party of responsibility for the performance of any accrued obligation which such Party has hereunder as of the time of such assignment. Any other attempted assignment of this Agreement in
violation of this Section 12.5 shall be null and void. 
 12.5.3 The terms and conditions of this Agreement shall be binding upon, and
shall inure to the benefit of, the Parties hereto and their respective successors and permitted assigns. 
 12.6 Severability. If any
provision of this Agreement is found invalid or unenforceable by a court of competent jurisdiction, the remainder of this Agreement shall continue in full force and effect. The Parties shall negotiate in good faith to substitute a valid, legal, and
enforceable provision that reflects the intent of such invalid or unenforceable provision. 
 12.7 Notices. 

12.7.1 The term “notice” as used throughout this Agreement, shall mean written notice, except where specifically provided herein to
the contrary. Notice shall be delivered by (i) certified mail, return receipt requested (or the equivalent); (ii) hand delivery with receipt acknowledged; or (iii) overnight courier service that provides a delivery receipt. Notices shall
be delivered to the following addresses or to such other address or person as a Party may specify by notice given in accordance with this Section 12.7.1. 

  
 38 

 If to Merck: 

[_______________] 

[_______________] 

[_______________] 
 Attention:
[_______________] 
 With a copy to: 

[_______________] 

[_______________] 

[_______________] 
 Attention:
[_______________] 
 If to Organon: 

[_______________] 

[_______________] 

[_______________] 
 Attention:
[_______________] 
 With a copy to: 

[_______________] 

[_______________] 

[_______________] 
 Attention:
[_______________] 
 12.7.2 Notice given in accordance with Section 12.7.1 shall be deemed delivered when received, or upon refusal of
receipt. 
 12.8 Cumulative Remedies. Except as otherwise expressly set forth herein, no remedy referred to in this Agreement is
intended to be exclusive, but each shall be cumulative and in addition to any other remedy available under the terms of this Agreement or otherwise available at law or in equity. 

12.9 Entire Agreement/Amendments; Conflicts. 

12.9.1 This Agreement, together with all Schedules and attachments hereto, and the other Transaction Documents, constitutes the entire
agreement between the Parties hereto and shall supersede and take the place of any and all agreements, documents, minutes of meetings, or letters concerning the subject matter hereof that may, prior to the Effective Date, be in existence. This
Agreement may only be amended by a statement in writing to that effect signed by duly authorized representatives of Organon and Merck. 

  
 39 

 12.9.2 The intent of this Agreement is to include items necessary for the proper execution
and completion of the performance under this Agreement. The documents comprised by this Agreement are complementary, and what is required by any one shall be as binding as if required by all. 

12.9.3 In the event of any conflict or inconsistency between the terms of the Separation and Distribution Agreement (or any other agreements
entered into between Merck Parent (or any of its Affiliates) and Organon (or any of its Affiliates) in connection with the Separation) and the terms of this Agreement, the terms of this Agreement shall govern with respect to the subject matter
hereof. 
 12.9.4 Except as set forth in Section 3.10 or as expressly set forth in any local country agreement entered into prior to
the Effective Date between the Parties or any of their respective Affiliates with respect to the provision of Services in anticipation of the Separation (each, a “Local Services Agreement”), this Agreement shall supersede each Local
Services Agreement with respect to the provision of such Services. To the extent there are any inconsistencies between this Agreement and any Local Services Agreement relating to such Services, this Agreement shall control. Notwithstanding the
foregoing, the appointment of a Party or its Affiliate as agent of the other Party or its Affiliate pursuant to an Interim Operating Agreement shall not be superseded by Section 12.1 of this Agreement and any provision of an Interim Operating
Agreement relating to Returns, Discards or Payment Claims shall not be superseded by Section 3.2.5 or 3.2.6 of this Agreement. 
 12.10
Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall for all purposes be deemed an original and all of which together shall constitute one and the same instrument. In addition, this Agreement
may be executed by facsimile or “PDF” and such facsimile or “PDF” signature shall be deemed to be an original. 
 12.11
Headings. The headings assigned to the Articles and Sections of this Agreement are for convenience only and shall not limit the scope and applicability of the Articles and Sections. 

12.12 Further Assurances. Each Party agrees to execute such further papers, agreements, documents, instruments and the like as may be
necessary or desirable to effect the purpose of this Agreement and to carry out its provisions. 
 12.13 English Language. If there
exist versions of this Agreement, or any Schedules, attachments or any amendments hereto or thereto, in any language other than English, the binding version of all of the foregoing shall be the English version, except as otherwise required by the
Laws. All notices and other written documentation provided by a Party to the other Party under this Agreement shall be in English, unless otherwise agreed to by the parties. 

12.14 Third Party Beneficiaries. Nothing in this Agreement, express or implied, is intended to confer upon any Third Party, any rights,
remedies, obligations or liabilities. 

  
 40 

 12.15 Interpretation. In this Agreement, unless otherwise specified, (i)
“includes” and “including” and words of similar import shall mean includes and including without limitation; (ii) words denoting any gender shall include all genders; (iii) words denoting the singular shall include the
plural and vice versa; (iv) the Exhibits, Schedules, Addenda and other attachments form part of the operative provision of this Agreement and references to this Agreement shall, unless the context otherwise requires, include references to the
Exhibits, Schedules, Addenda and attachments; (v) the word “or” is disjunctive but not necessarily exclusive; (vi) references to “Articles”, “Sections” and “subsections” in this Agreement shall be to
Articles, Sections and subsections respectively, of this Agreement unless otherwise specifically provided; (vii) references to any Articles or Sections include Sections and subsections that are part of the reference Article or Section
(e.g., a section numbered “Section 2.2(a)” would be part of “Section 2.2”, and references to “Article 2” or “Section 2.2” would refer to material contained in the subsection described as
“Section 2.2(a)”); and (viii) “herein,” hereby,” “hereunder,” “hereof,” “hereto” and other equivalent words shall refer to this Agreement as an entirety and not solely to the particular
portion of this Agreement in which any such word is used. Words and abbreviations that have known or technical trade meanings are used in this Agreement in accordance with such recognized meanings. 

12.16 Use of Affiliates. Either Party shall have the right to exercise its rights and perform its obligations under this Agreement
either itself or through any of its Affiliates, provided that such Party shall remain solely responsible for the acts, omissions and performance of such Affiliate as if such acts, omissions and performance had been provided by such Party itself
under this Agreement. In addition, in each case where a Party’s Affiliate has an obligation pursuant to this Agreement or performs an obligation pursuant to this Agreement: (i) such Party shall cause and compel such Affiliate to perform
such obligation and comply with the terms of this Agreement; and (ii) any breach of the terms or conditions of this Agreement by such Affiliate shall be deemed a breach by such Party of such terms or conditions. 

[Remainder of Page Intentionally Left Blank] 

  
 41 

 IN WITNESS WHEREOF, each of the Parties hereto has caused this Agreement to be duly executed
and delivered in its name and on its behalf, all as of the day and year first above written. 
  

			
	ORGANON:
	
	ORGANON LLC

 
			
		
	By:	 	  

	Name:	 	  

	Title:	 	  

 
			
	
	MERCK:
	
	MSD INTERNATIONAL GMBH

 
			
		
	By:	 	  

	Name:	 	  

	Title:EX-10.4

 
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 10.4 

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

by and between 
 SAMSUNG
BIOEPIS CO., LTD. 
 and 

MERCK SHARP & DOHME CORP. 

 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 

This Development and Commercialization Agreement (this “Agreement”) is effective as of February 18, 2013 (the “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 (“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 is developing the Compounds and the Products (each as hereinafter defined); and 

WHEREAS, Samsung is seeking a commercialization partner for the Compounds, and Merck desires to be such commercialization partner, upon the terms and
conditions set forth herein; 
 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 

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth
below. 
  

	1.1	 “Act” shall mean the Public Health Service Act, 42 U.S.C. §§ 262 et seq., as amended
from time to time. 

  

	1.2	 “Affiliate” shall mean (i) any corporation or business entity (A) of which, now or
hereafter, fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by Merck or Samsung or
(B) which, now or hereafter, is controlled directly or indirectly by Merck or Samsung; or (ii) any corporation or business entity (A) which, now or hereafter, directly or indirectly, owns, controls or holds fifty percent (50%) (or the
maximum ownership interest permitted by law) or more of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of Merck or Samsung or (B) which, now or
hereafter, directly or indirectly controls Merck or Samsung; or (iii) any corporation or business entity (A) of which, now or hereafter, fifty percent (50%) or more of the securities or other ownership interests representing the equity,
the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a corporation or business entity described in (i) or (ii) or (B) which, now or hereafter, is controlled directly or indirectly by a
corporation or business entity described in (i) or (ii). For the purpose of this Section 1.2 and Section 1.13, the term “control” shall mean the power and ability to direct the management and policies of the controlled
corporation or business entity, whether directly or indirectly through one or more intermediaries, through ownership of voting securities or other ownership interests of the controlled corporation or business entity or by contract or otherwise, and
the terms “controlled” and “controlling” shall be construed accordingly. Notwithstanding anything to the contrary contained in this Agreement, neither Biogen Idec Therapeutics Inc. nor any of its Affiliates (as defined in the
Joint Venture Agreement dated December 6, 2011 between Samsung BioLogics 

  
 1 

	 	
Co., Ltd. and Biogen Idec Therapeutics Inc.) shall be deemed to be an Affiliate of Samsung unless and until Biogen Idec Therapeutics Inc. and/or any of its Affiliates (as defined in the Joint
Venture Agreement referred to above), directly or indirectly, collectively own, control or hold fifty percent (50%) or more of the total issued and outstanding voting securities or other ownership interests of Samsung, in which event whether Biogen
Idec Therapeutics Inc. or any of its Affiliates (as defined in the Joint Venture Agreement referred to above) is an Affiliate of Samsung for purposes of this Agreement shall be determined in accordance with the foregoing definition of
“Affiliate.” 

  

	1.3	 “Agreement” shall have the meaning given such term in the preamble to this document.

  

	1.4	 “Biosimilar” shall mean any biological product: (i) characterized by the same amino acid
sequence and similar post-translational modifications as an approved reference product; (ii) for which any differences between it and its reference product do not result in any clinically meaningful differences in its safety, purity or potency
as compared to such reference product; and (iii) for which regulatory approval is expected to be sought or obtained based on the prior knowledge of such reference product under an abbreviated regulatory testing and/or filing scheme in the
United States or the European Union. 

  

	1.5	 “BLA” shall mean a Biologics License Application, Worldwide Marketing Application, Marketing
Authorization Application, filing pursuant to Section 351 of the Act, or similar application or submission for Marketing Authorization of a Product filed with a Regulatory Authority to obtain marketing approval for a biological product in that
country or in that group of countries. 

  

	1.6	 “Business Day” means a day other than a Saturday, Sunday, or a bank or
other public holiday in New York, New York or Seoul, Korea. 

  

	1.7	 “Calendar Quarter” shall mean the respective periods of three
(3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. 

  

	1.8	 “Calendar Year” shall mean each successive period of twelve (12) months commencing on
January 1 and ending on December 31. 

  

	1.9	 “Change of Control” shall mean with respect to a Party: (i) the sale of all or
substantially all of such Party’s assets or business relating to this Agreement; or (ii) a merger, reorganization or consolidation involving such Party in which the voting securities of such Party outstanding immediately prior thereto
cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation. 

 

	1.10	 “Clone” shall mean either (as the context requires): (i) a BLA for a Product submitted to a
Regulatory Authority in the European Union by Merck which is a duplicate of the BLA for such Product submitted to such Regulatory Authority by Samsung; or (ii) the Marketing Authorization received by Merck in the European Union in connection
with such a duplicate BLA. 

  

	1.11	 “Commercialize” shall mean to promote, market, distribute, sell and provide product support
for a Product, and “Commercializing” and “Commercialization” shall have correlative meanings. 

  
 2 

	1.12	 “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a
Party with respect to any objective, such reasonable, diligent, good faith efforts to accomplish such objective as a similarly situated (with respect to size, stage of development of products, and assets) pharmaceutical company would normally use to
accomplish a similar objective under similar circumstances. It is understood and agreed that with respect to the Development and Commercialization of a Compound and/or a Product by a Party, such efforts shall be substantially equivalent to the level
of efforts and resources normally devoted by a similarly situated (with respect to size, stage of development of products, and assets) pharmaceutical company to a product or compound which is owned by it or to which it has rights, which is of
similar market potential, profit potential or strategic value and at a similar stage in its development or product life, taking into account, without limitation, issues of safety and efficacy, approved labeling, product profile, proprietary
position, then-current competitive environment for such product or compound and likely timing of the product’s entry into the market, regulatory environment and status of the product, profitability of the product, and other relevant scientific,
technical and commercial factors. Commercially Reasonable Efforts shall be determined on a market-by-market and Indication-by-Indication basis for a particular product, and it is anticipated that the level of effort will be different for different markets, and will change over time, reflecting changes in the status of
the product and the market(s) involved. 

  

	1.13	 “Competing Pharma Change of Control” shall mean a Change of Control in which a company or
group of companies acting in concert (other than the Parties and their respective Affiliates) (a) for which the collective worldwide sales of ethical pharmaceutical products in the Calendar Year that preceded the Change of Control were [* * *]
United States dollars (US$[* * *]) or more, or (b) which has a research, development or commercialization program for a product which would compete with a Product, is the acquirer (by asset or business purchase) or becomes the controlling
equity holder of the surviving entity (as a result of a merger, consolidation or reorganization), as the case may be, as part of or as a result of such Change of Control. Notwithstanding anything to the contrary in this Agreement, in the event that
Biogen Idec Therapeutics Inc. or any of its Affiliates (as defined in the Joint Venture Agreement dated December 6, 2011 between Samsung BioLogics Co., Ltd. and Biogen Idec Therapeutics Inc.) comes to collectively own, control or hold fifty
percent (50%) or more of the total issued and outstanding voting securities or other ownership interests of Samsung, whether directly or indirectly (the “Biogen Change of Control of Samsung”), and at such time Biogen Idec
Therapeutics Inc. and/or any of such Affiliates (individually or collectively) meet the criteria set forth in (a) or (b) hereinabove, the Biogen Change of Control of Samsung shall constitute a Competing Pharma Change of Control.

  

	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; and 

 

	 	1.14.5	 Trastuzumab/Herceptin Biosimilar. 

 

	1.15	 “Control”, “Controls” or “Controlled by” shall
mean, with respect to any item of or right under Merck Know-How, Merck Patent Rights, Samsung Know-How or Samsung Patent Rights, the possession by a Party (whether by
ownership or license, other than pursuant to this Agreement) of the ability to grant access to, or a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement or other arrangement with any Third
Party. 

  
 3 

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

	1.16	 “current Good Manufacturing Practices” or “cGMPs” shall mean the applicable
then-current standards for conducting manufacturing activities for pharmaceutical or biological products (and/or active pharmaceutical ingredients) as are required by any applicable Regulatory Authority in the Territory. 

 

	1.17	 “Develop” shall mean to research, develop, analyze, test and conduct preclinical, clinical and
all other regulatory trials for a Compound and/or a Product, as well as any and all activities pertaining to analytical development, manufacturing process development and formulation development and all other activities related to securing or
maintaining Marketing Authorization for a Product. “Developing” and “Development” shall have correlative meanings. 

  

	1.18	 “EMA” shall mean the European Medicines Agency and any successor Regulatory Authority having
substantially the same function. 

  

	1.19	 “FDA” shall mean the United States Food and Drug Administration and any successor Regulatory
Authority having substantially the same function. 

  

	1.20	 “Filing” of a BLA shall mean the acceptance by a Regulatory Authority of a BLA for filing.

  

	1.21	 “Good Clinical Practices” or “GCPs” shall mean the applicable then-current
standards for clinical trials for pharmaceuticals or biologicals, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good clinical practice
as are required by any Regulatory Authority in the Territory. 

  

	1.22	 “Good Laboratory Practices” or “GLPs” shall mean the applicable then-current
standards for laboratory activities for pharmaceuticals or biologicals, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory
practice as are required by any Regulatory Authority in the Territory. 

  

	1.23	 “Indication” shall mean a separate and distinct disease or medical condition in humans which a
Product that is in clinical trials is intended to treat, prevent and/or diagnose and/or for which a Product has received Marketing Authorization. 

  

	1.24	 “Information” shall mean any and all Development, scientific,
pre-clinical, clinical, regulatory, Manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by one Party to
the other Party in connection with this Agreement. 

  

	1.25	 “Invention” shall mean any process, method, composition of matter, article of
manufacture, discovery or finding that is conceived and/or reduced to practice as a result of activities under this Agreement. 

  

	1.26	 “JSC” shall mean the joint steering committee established to oversee and review
the Development and Commercialization of Products, as more fully described in Section 3.4. 

  

	1.27	 “Launch” shall mean, with respect to a Product in a Region, the first sale in such Region by
Merck or its Related Parties to a Third Party for end use or consumption of such Product after receipt of the applicable Marketing Authorization for such Product in such Region, excluding, however, any sale or other distribution (in each case,
without receipt of any consideration for the Product sold or distributed, other than nominal consideration received in accordance with prevailing market practice) for test marketing, sampling or promotional uses, use in a clinical trial or
compassionate or similar uses. 

  
 4 

	1.28	 “Liability” shall mean any and all claims, suits, losses, liabilities, damages, costs, fees
and expenses, including reasonable attorneys’ fees and expenses of litigation incurred in connection therewith. 

  

	1.29	 “Manufacture” or “Manufacturing” shall
mean, with respect to a Compound or Product, the receipt, handling and storage of active pharmaceutical ingredients and other materials, the manufacturing, processing, packaging and labeling (excluding the development of packaging and labeling
components for Marketing Authorization), holding (including storage), quality assurance and quality control testing (including release) of such Compound or Product. 

 

	1.30	 “Marketing Authorization” shall mean all approvals from the relevant Regulatory Authority
necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals needed to obtain reimbursement in connection with the sale of Product, even if not legally required
to sell Product in a country). 

  

	1.31	 “Merck” shall have the meaning given such term in the preamble to this Agreement.

  

	1.32	 “Merck Information and Inventions” shall mean all protocols, formulas, data, Inventions, know-how and trade secrets, patentable or otherwise, developed or invented in connection with activities under this Agreement solely by employee(s) of Merck and/or its Affiliates and/or a Third Party acting on
behalf of Merck and/or its Affiliates. 

  

	1.33	 “Merck Know-How” shall mean all information and
materials, including but not limited to discoveries, improvements, processes, methods, protocols, formulas, data, inventions (including without limitation Merck Information and Inventions), know-how and trade
secrets, patentable or otherwise, which during the Term: (i) are owned or Controlled by Merck or any of its Affiliates; (ii) are not generally known; and (iii) are reasonably necessary to Samsung in the Development or Manufacturing of
any Compound or Product; excluding, however, any Samsung Information and Inventions and other Samsung Know-How. For the avoidance of doubt, such information and materials shall be Merck Know-How only for so long as they meet all of the requirements set forth in clauses (i), (ii) and (iii) above. 

  

	1.34	 “Merck Patent Rights” shall mean Patent Rights which during the Term are owned or
Controlled by Merck or any of its Affiliates, which (i) claim or cover any Compound and/or Product or (ii) claim or cover Merck Information and Inventions. For the avoidance of doubt, such Patent Rights shall be Merck Patent Rights only
for so long as they are owned or Controlled by Merck or any of its Affiliates and claim or cover any Compound and/or Product or claim or cover Merck Information and Inventions. 

 

	1.35	 “Net Sales” shall mean the gross invoice price (not including value added
taxes, sales taxes, or similar taxes) of Product sold by Merck or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received: 

 

	 	1.35.1	 trade and quantity discounts other than early payment cash discounts, which are actually made or
granted; 

  
 5 

	 	1.35.2	 returns, rebates, chargebacks and other allowances, which are actually made or granted;

  

	 	1.35.3	 retroactive price reductions that are actually made or granted; 

 

	 	1.35.4	 deductions to gross invoice price of Product imposed by Regulatory Authorities or other governmental
entities, which are actually made or granted; and 

  

	 	1.35.5	 a fixed amount equal to [* * *] of the amount invoiced (not including value added taxes, sales taxes, or
similar taxes) to cover bad debt, early payment cash discounts, transportation and insurance and custom duties. 

  

	1.36	 “Party” shall mean Merck or Samsung, individually, and
“Parties” shall mean Merck and Samsung, collectively. 

  

	1.37	 “Patent Rights” shall mean any and all patents and patent applications in
the Territory (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including divisionals, continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, pediatric
exclusivity periods and the like of any such patents and patent applications, and foreign equivalents of the foregoing. 

  

	1.38	 “Phase I Clinical Trial” shall mean a human clinical trial of Product conducted in accordance
with Good Clinical Practices in healthy volunteers and/or patients in any country, including the evaluation of similarity in pharmacokinetic profile of the Product versus the approved reference product in a head-to-head comparison. 

  

	1.39	 “Presentation” shall mean the particular filled and finished form of a Product (e.g.,
single use vial, syringe, autoinjector). 

  

	1.40	 “Product” shall mean any pharmaceutical preparation in final form that is comprised of,
incorporates or contains any Compound (i) for sale by prescription, over-the-counter or any other method; or (ii) for administration to human patients in a
clinical trial. 

  

	1.41	 “Product Criteria” shall mean the criteria with respect to Indications,
Presentations, dosage strengths and timing for receipt of Marketing Authorization set forth with respect to each Product on Schedule 1.41. 

  

	1.42	 “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”). 

 

	1.43	 “Regulatory Authority” shall mean any applicable government regulatory authority involved in
granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Product in the Territory. 

  

	1.44	 “Related Party” shall mean each of Merck, its Affiliates, and their respective sublicensees
(which term does not include distributors), as applicable. 

  
 6 

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

	1.45	 “Required M.A. Timing in EU” shall mean, with respect to each Product,
the timing set forth with respect to such Product in the column headed “Required Marketing Authorization Timing in EU” on Schedule 1.41. 

  

	1.46	 “Required M.A. Timing in USA” shall mean, with respect to each Product,
the timing set forth with respect to such Product in the column headed “Required Marketing Authorization Timing in USA” on Schedule 1.41. 

  

	1.47	 “Requirements” means all quantities of the Product that shall be required by Merck for
distribution, marketing and sale of the Product in the Territory. 

  

	1.48	 “Samsung” shall have the meaning given such term in the preamble to this Agreement.

  

	1.49	 “Samsung Information and Inventions” shall mean all protocols, formulas, data, Inventions, know-how and trade secrets, patentable or otherwise, developed or invented in connection with activities under this Agreement solely by employee(s) of Samsung and/or its Affiliates and/or a Third Party acting on
behalf of Samsung and/or its Affiliates. 

  

	1.50	 “Samsung Know-How” shall mean all information and
materials, including but not limited to, discoveries, improvements, processes, methods, protocols, formulas, data, inventions (including without limitation Samsung Information and Inventions), know-how and
trade secrets, patentable or otherwise, which during the Term: (i) are owned or Controlled by Samsung or any of its Affiliates; (ii) are not generally known; and (iii) are reasonably necessary or useful to Merck in connection with the
Commercialization of any Compound or Product in the Territory; excluding, however, any Merck Information and Inventions and other Merck Know-How. For the avoidance of doubt, such information and materials
shall be Samsung Know-How only for so long as they meet all of the requirements set forth in clauses (i), (ii) and (iii) above. 

 

	1.51	 “Samsung Patent Rights” shall mean Patent Rights which
during the Term are owned or Controlled by Samsung or any of its Affiliates, including, but not limited to, those listed on Schedule 1.51, which: (i) claim or cover any Compound and/or Product; or (ii) claim or cover Samsung Information
and Inventions. For the avoidance of doubt, such Patent Rights shall be Samsung Patent Rights only for so long as they are owned or Controlled by Samsung or any of its Affiliates and claim or cover any Compound and/or Product or claim or cover
Samsung Information and Inventions. 

  

	1.52	 “Specifications” shall mean the specifications for Compound(s) and Product(s) agreed between
the Parties. 

  

	1.53	 “Supply Price” of each unit of a Product in a particular
Presentation supplied by Samsung to Merck for sale in a Region shall mean the Target Supply Price determined under the Supply Price True-up Mechanism for such Product in such Presentation in such Region.

  

	1.54	 “Supply Price True-up
Mechanism” shall mean the mechanism set forth in Schedule 1.54 for the setting of the Supply Price for each Product in each of its Presentations in each Region, and the adjustment of the Supply Price for each Product in each
of its Presentations in each Region, on a Calendar Year basis. 

  
 7 

	1.55	 “Term” shall mean the period commencing upon the Effective Date and continuing until the
expiration and/or termination of this Agreement with respect to all of the Products in all Regions pursuant to Section 10.1, 10.2, 10.3, 10.4 and/or 10.5. 

 

	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; and 

  

	 	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. 

  

	1.57	 “Third Party” shall mean an entity other than Merck and its Related Parties, and Samsung and
its Affiliates. 

  

	1.58	 “Trademarks” shall mean any trademark (including but not limited to word marks, logos,
slogans, domain names, and the like) under which Compounds or Products are Commercialized under this Agreement. 

 ARTICLE 2
DEVELOPMENT OF COMPOUNDS AND PRODUCTS 
  

	2.1	 General. Samsung shall use Commercially Reasonable Efforts to carry out the Development of
Compounds and Products. Samsung shall be entitled to utilize the services of Third Parties to perform its Development activities; however, Samsung shall remain at all times fully liable for its responsibilities under this Agreement.

  

	2.2	 Records and Reports. 

 

	 	2.2.1	 Records. Samsung shall maintain records, in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the Development of Compounds and Products by Samsung. 

 

	 	2.2.2	 Semi-Annual Reports. No later than two (2) weeks prior to each regular
semi-annual meeting of the JSC held during the Term pursuant to Section 3.4.2, Samsung shall provide to Merck a written progress report in English which shall describe the work performed to date on the Development and Manufacturing of Compounds
and Products and provide such other information as may be reasonably requested by Merck relating to the Development and Manufacturing of Compounds and Products. 

 

	2.3	 Information and Inventions. The entire right, title and interest in:

  

	 	2.3.1	 Samsung Information and Inventions shall be owned solely by Samsung; and 

 

	 	2.3.2	 Merck Information and Inventions shall be owned solely by Merck. 

  
 8 

	2.4	 Exclusive Efforts. Throughout the Term, except for (i) the existing licensing, technical
development services and manufacturing arrangements (as amended by the parties to such arrangements in good faith from time to time, with any significant amendments to be notified to Merck) under (A) the License Agreement dated
February 29, 2012 between Biogen Idec Therapeutics Inc. and Samsung (the “Biogen License Agreement”), (B) the Technical Development Services Agreement dated February 29, 2012 between Samsung and Biogen Idec Therapeutics
Inc., (C) the Manufacturing Agreement dated February 29, 2012 between Samsung and Biogen Idec MA Inc. (and any quality agreement, quality control testing services agreement and/or similar agreement entered into or to be entered into in relation
thereto; collectively, the “Biogen Manufacturing Agreement”) and (D) the Manufacturing Agreement dated February 29, 2012 between Samsung and Samsung BioLogics Co., Ltd. (and any quality agreement, quality control testing
services agreement and/or similar agreement entered into or to be entered into in relation thereto; collectively, the “Samsung Manufacturing Agreement”) and (ii) other contract manufacturing activities of Samsung
BioLogics Co., Ltd. involving one or more Compounds and/or Products, Samsung shall not, and shall cause each of its Affiliates not to, Develop or Manufacture any Compound or Product for the Territory for or with any party other than Merck, or
Commercialize any Compound or Product in the Territory for itself or for or with any party other than Merck. Likewise, throughout the Term, Merck shall not, and shall cause each of its Affiliates not to, Develop or Manufacture any
Compound or Product for the Territory for itself or for or with any party other than Samsung, or Commercialize any Compound or Product in the Territory for or with any party other than Samsung. 

 

	2.5	 Compliance with Law and Ethical Business Practices. 

 

	 	2.5.1	 Samsung shall conduct its Development and Manufacturing activities in accordance with all applicable
laws, rules and regulations, including, without limitation, all current governmental regulatory requirements concerning Good Laboratory Practices, Good Clinical Practices and current Good Manufacturing Practices. Samsung shall notify Merck in
writing of any material deviations from applicable regulatory or legal requirements that could reasonably be expected to impact Merck. Samsung hereby certifies that it has not and will not employ or otherwise use in any capacity the services of any
person or entity debarred under Section 21 USC 335a in performing any activities under this Agreement. Samsung shall promptly notify Merck in writing if any such debarment comes to its attention, and shall promptly remove any person or entity
so debarred from performing any Development or Manufacturing activity. 

  

	 	2.5.2	 Samsung acknowledges that Merck’s corporate policy requires that Merck’s business must be
conducted within the letter and spirit of the law, and that Merck endeavors to hold itself and its business partners to the highest ethical and compliance standards, including basic human rights, encouraging fair and equal treatment for all persons,
the provision of safe and healthy working conditions, respect for the environment, the adoption of appropriate management systems and the conduct of business in an ethical manner. By signing this Agreement, Samsung agrees to conduct its Development
and Manufacturing activities hereunder in a manner which is consistent with both applicable law (including without limitation the U.S. Foreign Corrupt Practices Act, to the extent applicable to such activities) and good business ethics and generally
in accordance with Merck’s Code of Conduct (the current version of which is set forth at
http://www.merck.com/about/how-we-operate/code-of-conduct/values.html).

  
 9 

	 	2.5.3	 Samsung acknowledges that no employee of Merck or its Affiliates shall have authority to give any
direction, either written or oral, relating to the making of any commitment by Samsung or its agents to any Third Party in violation of the terms of this Section 2.5 or any other provisions of this Agreement. 

 

	 	2.5.4	 Samsung shall indemnify and hold Merck and its Affiliates harmless from and against any and all
Liabilities that may arise by reason of the acts or omissions of Samsung or its agents or other Third Parties acting on Samsung’s behalf which would constitute a violation of this Section 2.5. 

 

	2.6	 Animal Research. If animals are used in research hereunder, Samsung shall comply with the Animal Welfare
Act (to the extent applicable to such research by Samsung) or any other applicable local, state, national and international laws and regulations relating to the care and use of laboratory animals. Merck encourages Samsung to use the highest
standards, such as those set forth in the Guide for the Care and Use of Laboratory Animals (NRC, 1996), for the humane handling, care and treatment of such research animals. Any animals which are used in the course of the Development, or products
derived from those animals, such as eggs or milk, will not be used for food purposes, nor will these animals be used for commercial breeding purposes. 

ARTICLE 2A COMMERCIALIZATION OF COMPOUNDS AND PRODUCTS 
  

	2A.1	 General. Merck shall use Commercially Reasonable Efforts to carry out the Commercialization of Compounds
and Products in the Territory in accordance with an initial Commercialization plan to be prepared by Merck and provided to the JSC within [* * *] months after the Effective Date, as updated, supplemented and amended by Merck from time to time and
notified to the JSC (the “Commercialization Plan”). Merck shall be entitled to utilize the services of Third Parties to perform its Commercialization activities; however, Merck shall remain at all times fully liable for its
responsibilities under this Agreement. 

  

	2A.2	 Annual Reports. Within sixty (60) calendar days following the end of each Calendar Year
during the Term, Merck shall provide to Samsung a written progress report in English which shall describe the work performed to date on the Commercialization of Compounds and Products and provide such other information as may be reasonably requested
by Samsung relating to the Commercialization of Compounds or Products, including, without limitation, information on prices charged by Merck and/or its Related Parties to Third Parties, and other material pricing terms, for each Product in each of
its Presentations on a country-by-country basis. 

  

	2A.3	 Compliance with Law and Ethical Business Practices. 

 

	 	2A.3.1	 Merck shall conduct its Commercialization activities (including, without limitation, the preparation of any
promotional materials for Product) in accordance with (i) all applicable laws, rules and regulations, (ii) all applicable industry codes and standards and (iii) the Commercialization Plan in effect from time to time. Merck shall
notify Samsung in writing of any material deviations from applicable regulatory or legal requirements that could reasonably be expected to impact Samsung. Merck hereby certifies that it has not and will not employ or otherwise use in any capacity
the services of any person or entity debarred under Section 21 USC 335a in performing any activities under this Agreement. Merck shall promptly notify Samsung in writing if any such debarment comes to its attention, and shall promptly remove
any person or entity so debarred from performing any Commercialization activity. 

  
 10 

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

	 	2A.3.2	 By signing this Agreement, Merck agrees to conduct its Commercialization activities hereunder in a manner that
is consistent with both applicable law (including, without limitation, the U.S. Foreign Corrupt Practices Act, to the extent applicable to such activities) and good business ethics and in accordance with Merck’s Code of Conduct (the current
version of which is set forth at
http://www.merck.com/about/how-we-operate/code-of-conduct/values.html).

  

	 	2A.3.3	 Merck acknowledges that no employee of Samsung or its Affiliates shall have authority to give any
direction, either written or oral, relating to the making of any commitment by Merck or its agents to any Third Party in violation of the terms of this Section 2A.3 or any other provisions of this Agreement. 

 

	 	2A.3.4	 Merck shall indemnify and hold Samsung and its Affiliates harmless from and against any and all Liabilities
that may arise by reason of the acts or omissions of Merck or its agents or other Third Parties acting on Merck’s behalf which would constitute a violation of this Section 2A.3. 

ARTICLE 3 LICENSE; JOINT STEERING COMMITTEE; DEVELOPMENT; COMMERCIALIZATION 
  

	3.1	 License Grant. 

 

	 	3.1.1	 Samsung hereby grants to Merck an exclusive (even as to Samsung),
non-transferable license in the Territory under Samsung Patent Rights and Samsung Know-How, with the right to grant and authorize sublicenses, solely
(a) to Commercialize any and all Compounds and Products in the Territory, and (b) to use, import and export any and all Compounds and Products for purposes of Commercialization in the Territory; provided, however, that with
respect to Samsung Patent Rights and Samsung Know-How Controlled by Samsung or any of its Affiliates by way of a license or sublicense from a third party, the foregoing license granted to Merck pursuant to
this Section 3.1.1 shall be subject to the terms of such license or sublicense. 

  

	 	3.1.2	 Samsung shall retain the exclusive right to Develop and (subject to Section 6.1) Manufacture any
and all Compounds and Products. 

  

	 	3.1.3	 Merck hereby grants to Samsung an exclusive (even as to Merck),
non-transferable, royalty-free license in the Territory under Merck Patent Rights and Merck Know-How, with the right to grant and authorize sublicenses to
any of its Affiliates and/or to Biogen Idec MA Inc. and/or any of its Affiliates (as defined in the Biogen Manufacturing Agreement) that Manufacture any Compound or Product for or on behalf of Samsung pursuant to the Biogen Manufacturing Agreement
and/or, with Merck’s written consent (which consent shall not be unreasonably withheld or delayed), to Third Parties that Manufacture any Compound or Product for or on behalf of Samsung, solely to Develop and Manufacture any and all Compounds
and Products for Commercialization by Merck in the Territory; provided, however, that with respect to Merck Patent Rights and Merck Know-How Controlled by Merck or any of its Affiliates by way of
a license or sublicense from a third party, the foregoing license granted to Samsung pursuant to this Section 3.1.3 shall be subject to the terms of such license or sublicense. For the avoidance of doubt, notwithstanding the royalty-free
license granted to Samsung pursuant to this Section 3.1.3, royalties, license fees and other similar fees incurred or paid by Merck to any Third Party that constitute an element of “Merck Costs” under Schedule 1.54 shall be shared and
borne by Merck and Samsung through the Supply Price True-up Mechanism as set forth in Schedule 1.54. 

  
 11 

	 	3.1.4	 Merck shall retain the exclusive right to Commercialize any and all Compounds and Products in the
Territory. The Parties acknowledge that Merck and its Affiliates may authorize sublicensees, and shall engage distributors, in each case in accordance with Merck’s and its Affiliates’ general practice, to Commercialize the Products in the
Territory. Merck shall not, either itself or through or together with any of its Related Parties, engage in or carry out any Commercialization activities outside of the Territory with respect to any Compound or Product Developed and/or Manufactured
by, for or on behalf of Samsung. 

  

	 	3.1.5	 If and only if the Parties mutually agree to Develop a Compound originating from Merck, Merck shall
grant to Samsung an exclusive (even as to Merck), non-transferable license in the Territory under Merck Patent Rights and Merck Know-How, with the right to
grant and authorize sublicenses, to Develop such Compound and Product containing such Compound, and to Manufacture such Compound and Product containing such Compound to the extent mutually agreed by the Parties and upon the terms and conditions set
forth in a separate supply agreement entered into by the Parties. In such event, the Parties shall negotiate in good faith to enter into, concurrently with the execution of such supply agreement, an addendum to this Agreement that addresses the
rights and obligations of the Parties in respect of any Information, Inventions or Patent Rights that may be developed, conceived, made, reduced to practice or obtained from or based on such Compound or any Product containing such Compound.

  

	 	3.1.6	 It is understood and agreed by the Parties that, notwithstanding any other provision of this Agreement,
no licenses or rights will be granted and no Information or assistance will be provided by Merck to Samsung inside or outside of the Territory, or by Samsung to Merck for or in respect of any country or region outside of the Territory, with respect
to Adalimumab/Humira Biosimilar or Infliximab/Remicade Biosimilar; provided, however, that with respect to Adalimumab/Humira Biosimilar and Infliximab/Remicade Biosimilar, Merck shall (i) provide Information and assistance to
Samsung for or in respect of the Territory in accordance with Article 4, Sections 2A.1, 2A.2, 2A.3.1, 3.4.2, 3.9, 5.4, 6.3, 6.4, 6.9, 6.12, 6.14, 7.3, 8.7, 9.1, 9.2, 9.3 and 11.1 and Schedule 1.54, (ii) grant licenses to Samsung in respect of, and
assign to Samsung all rights, title and interests in and to, relevant Trademarks, promotional materials and other works in accordance with Section 3.7, and (iii) provide Information and assistance to an independent certified public
accounting firm selected by Samsung for audit and verification purposes in accordance with Section 7.2. 

  

	3.2	 Non-Exclusive License Grant. 

 

	 	3.2.1	 In the event that the Commercialization of a Compound or Product in the Territory, or the use, import or
export of a Compound or Product for purposes of Commercialization in the Territory, by Merck or its Related Parties would infringe during the Term a claim of issued letters patent which Samsung or any of its Affiliates owns or has the right to
license and which patents are not covered by the grant in Section 3.1, Samsung hereby grants to Merck, to the extent Samsung or such Affiliate is legally able to do so, a non-exclusive, non-transferable, sublicensable license under such issued letters patent solely for Merck and its Related Parties to Commercialize any and all Compounds and Products in the Territory, and to use, import and export
any and all Compounds and Products for purposes of Commercialization in the Territory. 

  

  
 12 

	 	3.2.2	 In the event that the Development or Manufacture of a Compound or Product for the Territory by Samsung
or any of its Affiliates and/or Third Parties that Manufacture any Compound or Product for or on behalf of Samsung would infringe during the Term a claim of issued letters patent which Merck or any of its Affiliates owns or has the right to license
and which patents are not covered by the grant in Section 3.1, Merck hereby grants to Samsung, to the extent Merck or such Affiliate is legally able to do so, a non-exclusive, non-transferable, sublicensable (only to the Affiliates of Samsung and/or to Biogen Idec MA Inc. and/or any of its Affiliates (as defined in the Biogen Manufacturing Agreement) that Manufacture any Compound or
Product for or on behalf of Samsung pursuant to the Biogen Manufacturing Agreement and, with Merck’s written consent (which consent shall not be unreasonably withheld or delayed), to Third Parties that Manufacture any Compound or Product for or
on behalf of Samsung), royalty-free license under such issued letters patent solely for Samsung and its Affiliates to Develop and Manufacture any and all Compounds and Products for the Territory; provided, however, that (i) if any
new or incremental royalty, license fee or similar fee would become payable to a Third Party as a result of a license granted to Samsung under this Section 3.2.2 or (ii) if (A) Merck or any of its Affiliates has an obligation to pay a
royalty, license fee or similar fee under an existing license agreement with a Third Party licensor with respect to such issued letters patent but neither Merck nor any of its Affiliates actually uses such license to engage in the licensed
activities and (B) Merck or such Affiliate grants a sublicense to Samsung under such Third Party license pursuant to this Section 3.2.2, such new or incremental royalty, license fee or similar fee (in the case of clause (i) above) or
such royalty, license fee or similar fee that is payable by Merck or such Affiliate to the Third Party licensor in respect of the period after such sublicense is granted to Samsung (in the case of clause (ii) above) shall be borne by Samsung;
provided further that in the case of clause (ii) above, if Merck or any of its Affiliates engages in any of the licensed activities after such sublicense is granted to Samsung, the foregoing royalty, license fee or similar fee
payable to the Third Party licensor shall be allocated and shared between Merck and Samsung based on the method of calculating such royalty, license fee or similar fee specified in the underlying license agreement with the Third Party licensor, or
in the absence of such contractual calculation method, on an equitable basis. For the avoidance of doubt, notwithstanding the royalty-free license granted to Samsung pursuant to this Section 3.2.2, royalties, license fees and other similar fees
incurred or paid by Merck to any Third Party that constitute an element of “Merck Costs” under Schedule 1.54 shall be shared and borne by Merck and Samsung through the Supply Price True-up Mechanism
as set forth in Schedule 1.54. 

  

	3.3	 No Implied Licenses. Except as specifically set forth in this Agreement, neither Party shall acquire any
license or other intellectual property interest, by implication or otherwise, in any Information disclosed to it under this Agreement or under any patents or patent applications owned or Controlled by the other Party or its Affiliates.

  

	3.4	 Joint Steering Committee. As soon as reasonably practicable following the Effective Date,
the Parties shall establish a committee to facilitate communications between the Parties and oversee and review the Development, Manufacturing and Commercialization of Compounds and Products, as follows: 

  
 13 

	 	3.4.1	 Composition of the Joint Steering Committee. The Development, Manufacturing and
Commercialization of Compounds and Products shall be overseen by a joint steering committee (the “JSC”) comprised of three (3) representatives of Merck and three (3) representatives of Samsung. Each Party may
change its representatives to the JSC from time to time in its sole discretion, effective upon notice to the other Party of such change. These representatives shall have appropriate technical credentials, experience and knowledge and ongoing
familiarity with the Products. Additional representative(s) or consultant(s) may from time to time, by mutual consent of the Parties, be invited to attend JSC meetings, subject to such representative’s or consultant’s written agreement to
comply with the requirements of Section 4.1. The position of chair of the JSC shall alternate each Calendar Year between a representative of Merck and a representative of Samsung. For the first Calendar Year during the Term, the JSC shall be
chaired by a representative of Samsung. The JSC shall not have decision-making authority, and shall act only as a consultative body. Each Party shall bear its own expenses related to the attendance of such meetings by its representatives.

  

	 	3.4.2	 Meetings. The JSC shall have two (2) regular semi-annual meetings in each Calendar
Year, unless otherwise mutually agreed by the Parties in writing, with the location for such meetings alternating between Samsung and Merck facilities (or such other location as may be determined by the JSC). Alternatively, the JSC may meet by means
of teleconference, videoconference or other similar communications equipment. The JSC shall confer regarding the status of the Development, Manufacturing and Commercialization of Compounds and Products and shall review and advise on any issues
relating to the Development, Manufacturing or Commercialization of Compounds or Products or this Agreement which may be referred to the JSC. In particular, the JSC shall confer regarding the progress and details of the device development program for
the Adalimumab/Humira Biosimilar and discuss potential benefits to be achieved over the devices for the reference product. In addition to the semi-annual meetings referred to above, the JSC shall meet to review the results of any Phase I Clinical
Trial of Product. The JSC shall also review and discuss any updates, supplements or amendments to the Commercialization Plan. Samsung shall submit to the JSC for review and discussion such information, data and materials relating to the Development
or Manufacturing of Compounds or Products hereunder as may be reasonably requested by any Merck representative to the JSC, and Merck shall submit to the JSC for review and discussion such information, data and materials relating to the
Commercialization of Compounds or Products hereunder as may be reasonably requested by any Samsung representative to the JSC. 

  

	3.5	 Development and Manufacture. 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). 

  

	3.6	 Commercialization. Merck shall have sole responsibility for the Commercialization of Compounds
and Products, and all regulatory activities relating to the Commercialization of Compounds and Products, throughout the Territory. Merck shall use Commercially Reasonable Efforts, at its own expense, to Commercialize each Product throughout the
Territory. In connection with the Commercialization of Compounds and Products hereunder, Merck hereby undertakes to perform and comply with the following: 

  
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	 	3.6.1	 Ensure that each Product is sold by Merck and its Related Parties to a Third Party at a reasonable
arm’s length price in each Region, and without limiting the generality of the foregoing, that the sale of a Product to a Third Party is not made by Merck or any of its Related Parties at a lower than arm’s length price for the purpose of
obtaining a more favorable price or more favorable terms for another product sold by Merck or any of its Related Parties to a Third Party; 

  

	 	3.6.2	 Maintain records and establish procedures necessary to ensure compliance with Section 2A.3.1
hereof; 

  

	 	3.6.3	 Direct the sublicensees, distributors and sales representatives of Merck and its Affiliates and those
Commercializing Product on Merck’s or its Affiliate’s behalf (collectively, “Sales Representatives”) to conduct their activities regarding the Products in a manner that is consistent with the applicable Product labeling
and accompanying inserts, the applicable promotional materials and all applicable laws, rules and regulations; 

  

	 	3.6.4	 Ensure that the Sales Representatives in each country or Region (as applicable) in the Territory are
properly trained with respect to any applicable: (a) regulatory guidance for industry-supported scientific and educational activities; (b) professional code on interactions with healthcare professionals; (c) standards for commercial
support of continuing medical education; (d) industry guidelines on gifts to physicians; and (e) federal, state and local laws, rules and regulations governing their Commercialization activities regarding the Products; and

  

	 	3.6.5	 Establish appropriate internal systems, policies and procedures for the monitoring of the Sales
Representatives with the goal of ensuring that the Sales Representatives conduct their Commercialization activities regarding the Products in compliance with all applicable laws, rules and regulations, all industry codes and standards applicable to
such Sales Representatives, and Merck’s Code of Conduct. 

  

	3.7	 Trademarks. The Trademarks under which the Products are Commercialized shall be created,
developed, selected and approved by Merck. Merck shall be responsible for filing, prosecuting, registering, maintaining and protecting the Trademarks in all countries in the Territory at its own expense. Samsung recognizes that the Trademarks are
trademarks of Merck and that Samsung has no right or interest in the Trademarks other than those rights explicitly granted in this Agreement. Merck shall own all copyright in any promotional materials or other works created in support of the
Commercialization of the Products. Notwithstanding the foregoing, (i) upon the expiration or termination of this Agreement with respect to a Product in less than all of its Presentations and/or in less than all Regions, Merck shall promptly
grant to Samsung an exclusive (even as to Merck), non-transferable, royalty-free license, with the right to grant and authorize sublicenses, to use, solely for and in support of the Commercialization of such
Product in such Presentation(s) and in such Region(s) for which this Agreement has expired or been terminated, (a) the Trademarks for such Product registered or used in such Region(s) and (b) all promotional materials and other works
created by, for or on behalf of, or used by, Merck or its Related Parties in support of the Commercialization of such Product in such Region(s) (which license shall remain in effect until all of Merck’s rights, title and interests in and to
such Trademarks, promotional materials and other works are assigned to Samsung pursuant to clause 

  
 15 

	 	
(ii) below); and (ii) upon the expiration or termination of this Agreement with respect to a Product in all of its Presentations and in all Regions, Merck shall promptly assign to Samsung
for no consideration all of its rights, title and interests in and to all such Trademarks, promotional materials and other works; provided, however, that Samsung shall bear all recordation costs and other incidental expenses associated
with such license or assignment. No license or assignment granted under this Section 3.7 shall include the right to use any Merck corporate name, corporate logo or other indicia of Merck’s corporate identity. 

 

	3.8	 Excused Performance. The obligations of the Parties with respect to a Product under Sections 3.5
and 3.6 are expressly conditioned upon the continuing absence of any material adverse condition or event affecting the safety or efficacy of such Product, and the obligation of Samsung to Develop and Manufacture or of Merck to Commercialize such
Product shall be delayed or suspended so long as in such Party’s reasonable opinion any such material adverse condition or event exists. For the purpose of this Section 3.8, a “material adverse condition or event” shall mean,
with respect to a particular Product in a particular Region, a condition or event implicating the safety or efficacy of such Product that is serious or unexpected to such a degree as to prevent Samsung from obtaining the necessary Marketing
Authorization(s) for such Product in such Region, or after obtaining such Marketing Authorization(s), to prevent Samsung from maintaining the continuing validity of such Marketing Authorization(s), or with the passage of time, to require a material
change in or to such Marketing Authorization(s). 

  

	3.9	 Adverse Experience Reporting. 

 

	 	3.9.1	 Within one hundred eighty (180) days 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, 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. 

 

	 	3.9.2	 Samsung shall establish and maintain all necessary pharmacovigilance requirements for the Products in
full compliance with all applicable laws and requirements of the Regulatory Authorities in the Territory. Merck shall establish and maintain appropriate pharmacovigilance systems to fulfill its responsibilities under the Pharmacovigilance Agreement.
For the European Union, where Merck shall be the holder of a Clone of Samsung’s Marketing Authorizations for the Products, the Parties shall outline in the Pharmacovigilance Agreement their respective responsibilities for reporting in
accordance with all applicable laws and requirements of the EMA. 

  

	 	3.9.3	 Throughout the Term, Merck shall notify Samsung in English within the timelines set forth in the
Pharmacovigilance Agreement 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. Merck and Samsung agree that the timelines set forth in the Pharmacovigilance Agreement for the reporting of adverse experiences by Merck and Samsung shall be in
accordance with all applicable regulatory requirements, which in the USA as of the Effective Date include a requirement that adverse experiences be reported within a maximum of five (5) calendar days. 

  
 16 

	 	3.9.4	 Merck’s responsibilities for the Products shall include: (i) notifying Samsung in writing by
secure e-mail or facsimile of any information concerning safety data within the timelines set forth in the Pharmacovigilance Agreement; (ii) with respect to any adverse experience report that is initially
made to or received by Merck, obtaining follow-up information thereon and forwarding same to Samsung in writing by secure e-mail or facsimile within the same timelines
as for the initial information; (iii) executing risk management plans established by Samsung in the Territory; (iv) executing safety signal communication activities to healthcare practitioners in the Territory; and (v) providing
reasonable assistance to Samsung in making regulatory and safety contacts with, and producing and submitting post-marketing periodic safety update reports to, the Regulatory Authorities in the Territory. 

 

	 	3.9.5	 Samsung’s responsibilities for the Products shall include: (i) receiving and processing all
post-marketing spontaneous adverse experience reports that originate in the Territory with respect to the Products, which reports shall be processed in accordance with Samsung’s Standard Operating Procedures for adverse experience reporting;
(ii) with respect to any adverse experience (as defined in the Pharmacovigilance Agreement) report that is initially made to or received by Samsung, obtaining follow-up information thereon (with the
understanding that if any follow-up information is received by Merck, it shall be forwarded to Samsung within the same timelines as for the initial information); (iii) making regulatory and safety contacts
with the Regulatory Authorities in the Territory as the holder of the relevant Marketing Authorization; (iv) producing and submitting post-marketing periodic safety update reports to the Regulatory Authorities in the Territory 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 Products. 

 

	 	3.9.6	 Samsung’s responsibilities for the Products 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; and (iv) establishing Territory-named pharmacovigilance contacts as required by
applicable laws and regulations. Samsung shall have the right, upon reasonable (at least thirty (30) days) prior written notice, to periodically audit Merck’s relevant Product-related pharmacovigilance activities to monitor compliance with
Merck’s obligations as set forth in this Section 3.9. Merck shall, within a reasonable time, reply to Samsung’s request for such audit. Such audit shall be reasonable in scope and take place during normal business hours. Samsung shall
not routinely request an audit more than once every two (2) years, except where there is a reasonable basis for Samsung to suspect that Merck has failed or is failing to comply with its obligations under this Section 3.9.

  

	 	3.9.7	 The Parties shall notify each other in writing promptly following the Effective Date of the names and
contact information of their respective employees or agents who are responsible for adverse experience reporting. 

  

	3.10	 Alliance Managers. 

 

	 	3.10.1	 Appointment. Each Party shall appoint an employee who shall oversee interactions between
the Parties for all matters related to this Agreement (each an “Alliance Manager”). Such persons shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and may
serve as a single point of contact for any matters arising under this Agreement. The Alliance Managers 

  
 17 

	 	
shall have the right to attend all JSC meetings as non-voting participants and may bring to the attention of the JSC any matters or issues either of them
reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. Each Party may change its Alliance Manager by notice in writing to the other Party. 

 

	 	3.10.2	 Responsibilities of the Alliance Managers. The Alliance Managers shall have the
responsibility of creating and maintaining a constructive work environment between the Parties. Without limiting the generality of the foregoing, each Alliance Manager shall: 

 

	 	(a)	 identify and bring disputes and issues that may result in disputes (including without limitation any asserted
occurrence of a material breach by a Party) to the attention of the JSC in a timely manner, and function as the point of first referral in all matters of conflict resolution; 

 

	 	(b)	 provide a single point of communication for seeking consensus both internally within the Parties’
respective organizations and between the Parties; 

  

	 	(c)	 plan and coordinate cooperative efforts, internal communications and external communications between the
Parties with respect to this Agreement; and 

  

	 	(d)	 take responsibility for ensuring that meetings and the production of meeting agendas and minutes occur as set
forth in this Agreement, and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed. 

ARTICLE 4 CONFIDENTIALITY AND PUBLICATION 
  

	4.1	 Nondisclosure Obligation. All Information disclosed or made available by one Party to the
other Party hereunder (including, for the avoidance of doubt, (i) all Information disclosed or made available by Samsung to Merck to enable Merck to obtain and maintain a Clone, (ii) all Information disclosed or made available by Samsung
to Merck or otherwise acquired by Merck in connection with the inspection and audit of any Manufacturing facility pursuant to Section 6.10, (iii) all Information provided or made available by Samsung to Merck pursuant to Section 8.3, and
(iv) all Information provided or made available by a Party to the other or exchanged between the Parties pursuant to Section 9.1, 9.2 or 9.3) shall be maintained in confidence by the receiving Party and shall not be disclosed to any of its
Affiliates or any Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party, except to the extent that such Information: 

 

	 	4.1.1	 is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the
disclosing Party, as documented by the receiving Party’s business records; 

  

	 	4.1.2	 is in the public domain by use and/or publication before its receipt from the disclosing Party, or
thereafter enters the public domain through no fault of the receiving Party; 

  

	 	4.1.3	 is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not
under an obligation of confidentiality to the disclosing Party; 

  
 18 

	 	4.1.4	 is developed by the receiving Party independently of Information received from the disclosing Party, as
documented by the receiving Party’s business records; 

  

	 	4.1.5	 is disclosed to governmental or other regulatory agencies in order to obtain patents or to gain or
maintain approval to conduct clinical trials or to market Product, but such disclosure may be only to the extent reasonably necessary to obtain patents or authorizations; 

 

	 	4.1.6	 is reasonably deemed necessary by Samsung to be disclosed to its Affiliates, its and such
Affiliates’ respective directors, officers and employees, and any agent(s), consultant(s) and/or other Third Parties for any and all purposes Samsung deems necessary or advisable in connection with the Development or Manufacture of any Compound
or Product, on the condition that each such Affiliate, director, officer, employee and Third Party agrees to be bound by confidentiality and non-use obligations that substantially are no less stringent than
those confidentiality and non-use provisions contained in this Agreement; provided, however, that the term of confidentiality for such Affiliates, directors, officers, employees and Third Parties
shall be no less than ten (10) years; 

  

	 	4.1.7	 is reasonably deemed necessary by Merck to be disclosed to its Related Parties, its and such Related
Parties’ respective directors, officers and employees, and any agent(s), consultant(s) and/or other Third Parties for any and all purposes Merck deems necessary or advisable in connection with the Commercialization of any Compound or Product,
on the condition that each such Related Party, director, officer, employee and Third Party agrees to be bound by confidentiality and non-use obligations that substantially are no less stringent than those
confidentiality and non-use provisions contained in this Agreement; provided, however, that the term of confidentiality for such Related Parties, directors, officers, employees and Third Parties
shall be no less than ten (10) years; 

  

	 	4.1.8	 is reasonably deemed necessary by counsel to the receiving Party to be disclosed to such Party’s
attorneys, independent accountants or financial advisors for the sole purpose of enabling such attorneys, independent accountants or financial advisors to provide advice to the receiving Party, on the condition that such attorneys, independent
accountants and financial advisors agree to be bound by the confidentiality and non-use obligations contained in this Agreement; provided, however, that the term of confidentiality for such
attorneys, independent accountants and financial advisors shall be no less than [* * *] years; or 

  

	 	4.1.9	 is required to be disclosed in order for the receiving Party to exercise or enforce its rights under
this Agreement. 

 Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions
merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in
the rightful possession of the receiving Party. 
 If a Party is required by law, court order or judgment or judicial or administrative
process to disclose Information that is subject to the non-disclosure provisions of this Section 4.1 or Section 4.3, such Party shall promptly inform the other Party of the disclosure that is being
sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Information that is disclosed pursuant to law, court order or judgment or judicial or administrative

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

 
process shall remain otherwise subject to the confidentiality and non-use provisions of this Section 4.1 and Section 4.3, and the Party
disclosing Information pursuant to law, court order or judgment or judicial or administrative process shall take all steps reasonably necessary, including without limitation obtaining an order of confidentiality (if available), to ensure the
continued confidential treatment of such Information. 
  

	4.2	 Publication. Merck acknowledges Samsung’s interest in publishing the results of its
research and development in order to obtain recognition within the scientific community and to advance the state of scientific knowledge. Each Party also recognizes the mutual interest in obtaining valid patent protection and in protecting business
interests and trade secret information. Consequently, except for disclosures permitted pursuant to Section 4.1, either Party, its Affiliates, or their respective employee(s) or consultant(s) wishing to make a publication relating to a Compound
or Product shall deliver to the other Party a copy of the proposed written publication or an outline of an oral disclosure at least sixty (60) calendar days prior to submission for publication or presentation. The reviewing Party shall have the
right (a) to propose modifications to the publication or presentation for patent reasons, trade secret reasons or business reasons or (b) to request a reasonable delay in publication or presentation in order to protect patentable
information. If the reviewing Party requests a delay, the publishing Party shall delay submission or presentation for a period of up to ninety (90) calendar days as necessary to enable patent applications to be filed in accordance with Article
9, if applicable. Upon expiration of such ninety (90) calendar days, the publishing Party shall be free to proceed with the publication or presentation. If the reviewing Party requests modifications to the publication or presentation, the
publishing Party shall edit such publication or presentation by reflecting such requested modifications to the extent reasonably necessary to prevent disclosure of trade secret or proprietary business information prior to submission for publication
or presentation. 

  

	4.3	 Publicity/Use of Names. No disclosure of the existence, or the terms, of this Agreement may be
made by either Party, and no Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject
matter, without the prior express written permission of the other Party, except as may be required by law, court order or judgment or judicial or administrative process, or except to the extent reasonably necessary for a Party to exercise or enforce
its rights under this Agreement. In the event a Party is required to file a copy of this Agreement with a Regulatory Authority or any other governmental authority or agency, (i) such Party shall redact the list of Biosimilars set forth in
Section 1.14 (definition of “Compound”) 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 Agreement that the disclosing Party proposes to file, with not less than thirty (30) 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. 

 ARTICLE 5 PAYMENTS FOR LICENSES GRANTED TO MERCK; TAX 

 

	5.1	 Payments for Licenses Granted to Merck. In consideration for the exclusive license granted to Merck
under Section 3.1.1 and any non-exclusive license that may be granted to Merck under Section 3.2.1, upon the terms and conditions contained herein, Merck shall pay to Samsung the milestone license
fees set forth in Section 5.2 below. 

  
 20 

	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 payment pursuant to Section 5.2.1, which payment shall be made only once in respect of all Products); provided, however, that
(i) the payments pursuant to Sections 5.2.1 and 5.2.2 shall be made regardless of whether any Product Criteria are met, (ii) the payment pursuant to Section 5.2.3 shall be made regardless of whether the relevant Product meets the
Required M.A. Timing in EU, and (iii) the payment pursuant to Section 5.2.4 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 thirty (30) calendar days after the first successful completion in the USA or EU of a
Phase I Clinical Trial of such Product 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 above 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: [* * *]; 

  

	 	5.2.3	 Within thirty (30) calendar days after the receipt of the first Marketing Authorization from
the FDA for such Product: [* * *]; 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 

  

	 	5.2.4	 Within thirty (30) calendar days after the receipt of the first Marketing Authorization from
the EMA for such Product (excluding Adalimumab/Humira Biosimilar and Infliximab/Remicade Biosimilar): [* * *]; 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). 

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

 Each of the above milestone license fees (other than the amount set forth in
Section 5.2.1) 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. 
  

	5.3	 Payments. All payments to be made by Merck to Samsung under this Agreement shall be
made in United States dollars and shall be paid by bank wire transfer in immediately available funds to a bank account designated in writing by Samsung from time to time. 

 

	5.4	 Income Tax Withholding. Samsung shall be liable for all income and other taxes
(“Taxes”) imposed upon the milestone license fees paid by Merck to Samsung under this Article 5. If applicable laws, rules or regulations require the withholding of taxes, Merck shall make such withholding and subtract
the amount thereof from the milestone license fees. Merck shall submit to Samsung appropriate proof of payment of the withheld Taxes as well as the official receipts within a reasonable period of time. Merck shall provide Samsung reasonable
assistance in order to allow Samsung to obtain the benefit of any present or future treaty against double taxation which may apply to the milestone license fees. 

ARTICLE 6 MANUFACTURE AND SUPPLY; QUALITY 
  

	6.1	 Manufacture and Supply of Compounds and Products. Except to the extent otherwise expressly agreed
by the Parties in writing, Samsung shall be responsible for the Manufacture (itself or through one or more Affiliates or Third Parties) and supply of Merck’s Requirements of Products for Commercialization in the Territory. Such Products shall,
in each case, meet the Specifications, cGMPs and all applicable laws and regulations in the Territory. 

  

	6.2	 Supply of Merck’s Requirements. Subject to the terms and conditions hereof, Samsung shall supply to
Merck, and Merck shall purchase from Samsung, Merck’s Requirements of Product. The Parties acknowledge that Merck intends to build and maintain for Launch an inventory of [* * *] of the expected Requirements of each Product, as estimated
in good faith to be needed at the time of Launch of such Product. 

  

	6.3	 Forecasts. 

 

	 	6.3.1	 No later than thirty (30) days after submission of the first application for Marketing
Authorization for any Product, Merck shall provide Samsung with an initial forecast of Merck’s Requirements of Products for Commercialization in the Territory for each of the succeeding [* * *] Calendar Quarters. Thereafter, on or before the
tenth day of January, April, July and October of each year during the Term, Merck shall provide Samsung with a rolling forecast of Merck’s Requirements of Products for each of the succeeding [* * *] (each such initial and subsequent forecast
being referred to herein as a “Rolling Forecast”). 

  
 22 

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

	 	6.3.2	 The first [* * *] Calendar Quarters of each Rolling Forecast shall include a binding forecast of the
total quantity of bulk drug substance (“Bulk Drug Substance”) for each Product (in kilograms or other relevant measure) that will be required for such [* * *] Calendar Quarters (each, a “Binding Forecast for Bulk Drug
Substance”). The Parties agree that, subject to Sections 6.3.5 and 6.3.6, such Binding Forecast for Bulk Drug Substance shall be binding on the Parties in each of the four (4) Calendar Quarters and shall represent a binding commitment
for Samsung to supply to Merck, and for Merck to pay for, the corresponding quantities of Products (that can be Manufactured using the forecasted quantities of Bulk Drug Substances) in each such Calendar Quarter. The forecast for the last [* * *]
Calendar Quarters of each Rolling Forecast (the first of such four Calendar Quarters being referred to herein as the “Semi-Binding Calendar Quarter”), which constitutes a non-binding forecast,
shall include Merck’s good faith estimates of its Requirements of Bulk Drug Substances for Products (by Product) for each of such [* * *] Calendar Quarters; provided, however, that in the next Rolling Forecast provided by Merck,
the quantity of Bulk Drug Substance for each Product forecasted for the Semi-Binding Calendar Quarter, which as of such next Rolling Forecast shall become part of a Binding Forecast for Bulk Drug Substance (i.e., as the fourth Calendar
Quarter of such Binding Forecast for Bulk Drug Substance), shall not exceed [* * *] or be less than [* * *] of the quantity of Bulk Drug Substance for such Product forecasted for such Semi-Binding Calendar Quarter in the immediately preceding
Rolling Forecast for Bulk Drug Substance (i.e., as the fifth Calendar Quarter of such preceding Rolling Forecast). 

  

	 	6.3.3	 Likewise, each Rolling Forecast shall include a binding forecast of the total quantity of each of the
Required Presentations (as defined in the Product Criteria and as set forth in more detail in Section 6.3.3(a) below) for each Product and a binding forecast of the total quantity of each specific-market-labeled stock keeping unit of each of
the Required Presentations for each Product as follows: 

  

	 	(a)	 The first [* * *] of each Rolling Forecast shall include a binding forecast of the total quantity of each of
the Required Presentations for each Product (in units) that will be required for such [* * *] (each, a “Binding Forecast for Primary-Packaged Presentations”): 

 

	 	(i)	 [* * *]; 

  

	 	(ii)	 [* * *]; 

  

	 	(iii)	 [* * *]; 

  

	 	(iv)	 [* * *]; 

  

	 	(v)	 [* * *]; 

  

	 	(vi)	 [* * *]; 

  
 23 

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

	 	(vii)	 [* * *]; 

  

	 	(viii)	 [* * *]; 

  

	 	(ix)	 [* * *]; 

  

	 	(x)	 [* * *]; and 

  

	 	(xi)	 [* * *]. 

  

	 	(b)	 Moreover, the [* * *] of each Rolling Forecast shall include a binding forecast of the total quantity of each
specific-market-labeled stock keeping unit (SKU) of each of the Required Presentations for each Product (in units) that will be required for such Calendar Quarter (each, a “Binding Forecast for Secondary-Packaged Presentations,” and
together with Binding Forecasts for Bulk Drug Substance and Binding Forecasts for Primary-Packaged Presentations, each referred to herein as a “Binding Forecast”). 

 

	 	(c)	 Each Binding Forecast for Primary-Packaged Presentations for each Calendar Quarter shall be based on and
consistent, in terms of Manufacture and release cycle times (as communicated by Samsung through the D&OP Team), with the Binding Forecast for Bulk Drug Substance for the applicable Calendar Quarter. Each Binding Forecast for Secondary-Packaged
Presentations for each Calendar Quarter shall be based on and similarly consistent with the Binding Forecast for Bulk Drug Substance for the applicable Calendar Quarter and the Binding Forecast for Primary-Packaged Presentations for the applicable
Calendar Quarter. 

  

	 	(d)	 The Parties agree that, subject to Sections 6.3.5 and 6.3.6, each such Binding Forecast for Primary-Packaged
Presentations and Binding Forecast for Secondary-Packaged Presentations shall be binding on the Parties and shall represent a binding commitment for Samsung to supply to Merck, and for Merck to pay for, the corresponding forecasted
quantities of Products in the applicable Calendar Quarter. 

  

	 	6.3.4	 Samsung shall promptly, but in no event later than fourteen (14) calendar days from receipt of each
Rolling Forecast, notify Merck if it anticipates that it will be unable to meet any portion of any of the forecasted Requirements, in which case the Parties shall negotiate in good faith to make necessary adjustments to the forecasted Requirements
in order to accommodate Samsung’s concerns or requests to the extent reasonably possible, while still meeting Merck’s Requirements specified in the relevant Binding Forecast (except to the extent adjusted by mutual agreement of the
Parties). 

  

	 	6.3.5	 Should Merck need to cancel or defer the Manufacturing of any quantity of Bulk Drug Substance or Product
(the “Cancelled or Deferred Quantity”) covered by a Binding Forecast for Bulk Drug Substance, a Binding Forecast for Primary-Packaged Presentations or a Binding Forecast for Secondary-Packaged Presentations (the “Affected
Binding Forecast”) for any reason, Merck shall promptly notify Samsung in writing (each, a “Cancellation or Deferral Notice”). In such event, the Parties shall exercise Commercially Reasonable Efforts to mitigate any
Operational Costs (as defined below) associated with such cancellation or deferral. “Operational Costs” shall include (i) the 

  
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costs of any raw materials, resins or other consumables which Samsung is not able to use for scheduled Manufacturing, whether for Merck, for Samsung or for any Third Party, as well as
(ii) the other costs included in “Samsung Costs” as defined in Schedule 1.54 (excluding, however, royalties and license fees and personnel-related expenses of Commercialization support departments) that Samsung is unable to mitigate
or avoid through the exercise of Commercially Reasonable Efforts. To the extent Samsung is able to utilize its own Manufacturing facility either for itself or its Affiliate or for any Third Party in the timeframe in which such facility would have
been used to Manufacture the Cancelled or Deferred Quantity for Merck, Merck shall not be liable for Operational Costs related to such Cancelled or Deferred Quantity. If the Manufacturing of the Cancelled or Deferred Quantity was to be performed by
a Third Party Manufacturer, and Samsung is able to cancel or defer the Manufacturing of such Cancelled or Deferred Quantity without paying for such Cancelled or Deferred Quantity and without paying any cancellation, deferral or similar fees, Merck
shall not be liable to Samsung for any Operational Costs with respect thereto. If Merck pays for raw materials, resins or other consumables as part of Operational Costs, Merck may elect to have such materials sent to a Merck facility at Merck’s
expense. 

  

	 	6.3.6	 If the Manufacturing of the Cancelled or Deferred Quantity has already taken place (as further described
in the third sentence of this Section 6.3.6) when the relevant Cancellation or Deferral Notice is given to Samsung or is to take place (as further described in the third sentence of this Section 6.3.6) within the next twelve
(12) months after such notice is given to Samsung, Merck shall pay to Samsung [* * *] of Samsung’s Operational Costs associated with such cancellation or deferral. If the Manufacturing of the Cancelled or Deferred Quantity is to take place
(as further described in the third sentence of this Section 6.3.6) more than twelve (12) months after the relevant Cancellation or Deferral Notice is given to Samsung, Merck shall not be liable to Samsung for any Operational Costs with
respect to such cancellation or deferral. For the purpose of this Section 6.3.6, the Manufacturing of the Cancelled or Deferred Quantity shall be deemed to have taken place or to take place (as the case may be) at the following point in time:
(a) if such Cancelled or Deferred Quantity is of Bulk Drug Substance, four (4) months before the last day of the Calendar Quarter for which such Cancelled or Deferred Quantity of Bulk Drug Substance was originally forecasted in the
Affected Binding Forecast; and (b) if such Cancelled or Deferred Quantity is of a Product (whether in Primary-Packaged Presentations or in Secondary-Packaged Presentations), six (6) months before the last day of the Calendar Quarter for
which such Cancelled or Deferred Quantity of Product was originally forecasted in the Affected Binding Forecast. Notwithstanding the foregoing, if Merck does not cancel the Manufacturing of a Bulk Drug Substance batch covered by a Binding Forecast
for Bulk Drug Substance, but merely defers the Manufacturing of such Bulk Drug Substance batch to the Calendar Quarter immediately following the Calendar Quarter for which such Bulk Drug Substance batch was originally forecasted in such Binding
Forecast for Bulk Drug Substance, Merck shall not be liable to Samsung for any Operational Costs with respect to such deferral; provided, however, that if such deferral is made more than twice in any Calendar Year, the foregoing
sentence shall apply only to the first two (2) deferrals, and not to any additional deferral(s) that may be made in such Calendar Year. For the avoidance of doubt, under and for the purpose of the Supply Price
True-up Mechanism, (i) no Cancelled or Deferred Quantity shall be included in determining “Supply Volume” and (ii) no Operational Costs paid by Merck to Samsung pursuant to
Section 6.3.5 and this Section 6.3.6 shall be reflected or taken into account in determining “Samsung Costs” or “Merck Costs.” 

  
 25 

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	 	6.3.7	 On or before the end of the [* * *] of each Calendar Year during the Term, Merck shall provide Samsung
with a written forecast (each, a “Long Range Forecast”) of its estimated annual Requirements for the Products for the next succeeding [* * *] Calendar Years (covering the Calendar Year in which the forecast is delivered and the next
succeeding [* * *] Calendar Years), which forecast, to the extent reasonably practicable, shall be broken down by Product. The Long Range Forecast shall be non-binding. If at any time the Long Range Forecast
reasonably suggests any problems in relation to Samsung’s Manufacturing capacity, the Parties shall discuss in good faith how to address the potential shortage. 

 

	 	6.3.8	 The Parties shall establish a Demand and Operations Planning Team (the “D&OP
Team”). The D&OP Team shall act in a review capacity only, with no separate approval rights, and shall advise the Parties and the JSC on the management and resolution of commercial supply issues between the Parties. The D&OP Team
shall be comprised of the same number of representatives from each Party, as determined by the JSC. No later than thirty (30) days after the Filing of the first BLA for the first Product, each Party shall identify a team coordinator from such
Party to co-lead the D&OP Team. Such team coordinators shall mutually determine when the first meeting of the D&OP Team will occur, and thereafter, the D&OP Team shall meet on a periodic basis as
determined by the D&OP Team coordinators, along with other appropriate members designated by the Parties, by videoconference or teleconference. The D&OP Team shall meet to review the following topics: (i) demand forecasting, supply plan
and Product ordering (including supply collars) and quality obligations; (ii) specific delivery dates with respect to Products and the quality of Bulk Drug Substance and Products; (iii) Manufacturing capacity and Manufacture and release
cycle times for Bulk Drug Substance and Products, along with any identified or projected shortages of Bulk Drug Substance or Product; (iv) applicable timelines with respect to regulatory requirements and dating for Products; and
(v) establishment of joint key performance indicators to measure the effectiveness of forecasts and delivery performance. The D&OP Team shall review annually the Long Range Forecast, report to the JSC any projected capacity shortages that
could impact supply and engage in pre-planning activities to mitigate the impact of possible supply failure as described in Section 6.6. The D&OP Team shall also undertake capacity assessments and
other actions to review supply, demand and production as assigned by the JSC and notify the JSC of any material issues impacting supply. 

  

	6.4	 Purchase Orders. At the time the initial Binding Forecast for Secondary-Packaged
Presentations is provided to Samsung pursuant to Section 6.3, Merck shall issue to Samsung a written binding purchase order for the quantity of each SKU of each Product indicated in such initial Binding Forecast for Secondary-Packaged
Presentations. With each subsequent Binding Forecast for Secondary-Packaged Presentations, Merck shall issue to Samsung a written binding purchase order for the quantity of each SKU of each Product indicated for the new Calendar Quarter covered by
such Binding Forecast for Secondary-Packaged Presentations that was not covered by the previous Binding Forecast for Secondary-Packaged Presentations. The requested dates of delivery of the Products specified in each purchase order shall be at least
[* * *] calendar days after the date of issuance of such purchase order to Samsung. Within fourteen (14) calendar days of receipt of a purchase order, Samsung shall deliver to Merck a written confirmation of such order. Upon receipt by
Merck of Samsung’s confirmation, Merck shall be obligated to buy, and Samsung shall be obligated to sell, the quantities of the Products set forth in the purchase order by the requested delivery dates set forth in such purchase order. If Merck
fails to buy any quantity of Product set forth in a purchase order by the requested delivery date set forth in such purchase order, (i) Merck shall pay to Samsung one hundred percent (100%) of Samsung’s

  
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Operational Costs associated with such quantity of Product, and (ii) under and for the purpose of the Supply Price True-up Mechanism, (A) such
quantity of Product shall not be included in determining “Supply Volume” and (B) no Operational Costs paid by Merck to Samsung pursuant to this Section 6.4 shall be reflected or taken into account in determining “Samsung
Costs” or “Merck Costs.” 

  

	6.5	 Expiration Dating at Time of Shipment. The Parties agree that it is in their mutual interest to achieve
the same shelf life for each Product as its respective reference product may have. In any event, the Parties shall achieve [* * *] shelf life for each Product at the time of Launch and shall use Commercially Reasonable Efforts to extend the
shelf life to the same shelf life as its reference product as soon thereafter as possible; provided that a failure to extend such shelf life for one or more Products, standing alone, shall not constitute a material breach by either Party of
its obligations hereunder for the purpose of Section 10.3.1. Unless the Parties agree otherwise in writing, the shelf life of each Product shall be determined from the date of final sterile filtration of the formulated Compound and shall be
based on the approved shelf life of the Product. 

  

	 	6.5.1	 If a Product is approved with a [* * *] month shelf life, Samsung shall be obligated to deliver the
Product to Merck within [* * *] calendar days of completion of filling such Product. 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 [* * *] calendar day period despite the exercise of Commercially Reasonable Efforts to do so, in which case such inability shall not, standing alone, constitute a breach of this Agreement. 

 

	 	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 [* * *] months, Samsung shall use Commercially Reasonable Efforts to deliver the Product to Merck within [* * *] calendar days from the completion of the final sterile filtration. Merck may, in its sole discretion, accept such
Product after the [* * *]-day deadline on a case-by-case basis. A failure to comply with the [* * *]-day deadline shall not, standing alone, constitute a breach of this
Agreement. 

  

	 	6.5.3	 Upon request from Merck, Samsung shall deliver a Product to Merck which has not been released, subject
to such Product being held under quarantine in accordance with procedures which have been mutually agreed upon by the Parties in advance of the first such delivery. Merck shall indemnify, defend and hold Samsung, its Affiliates and its and such
Affiliates’ respective directors, officers, employees and agents harmless from and against any and all Liabilities that may arise from or by reason of the sale, distribution or use of such Product outside of the agreed procedures by Merck, any
of its Related Parties or any Third Party. 

  

	6.6	 Inability to Supply. 

 

	 	6.6.1	 In the event that Samsung indicates in either its notice pursuant to Section 6.3.4, or its
confirmation pursuant to Section 6.4, that it has reason to believe that it will be unable to supply Merck, by the delivery dates on the purchase order, with the full quantity of a Product forecasted to be ordered or actually ordered by Merck,
as the case may be (an “Anticipated Supply Shortfall”), then the Parties shall promptly establish a Joint Manufacturing Committee to consider solutions, including without limitation the following: (i) increasing the
length/frequency of the Manufacturing campaign at the facility where the relevant Compound or Product is Manufactured; (ii) utilizing any capacity at the facility where the relevant Compound or Product is Manufactured which

  
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is then committed to the Manufacture of other products during the applicable period to Manufacture an additional quantity of such Compound or Product, as applicable, to remedy the Anticipated
Supply Shortfall; and/or (iii) dedicating or acquiring additional capacity, at Samsung’s sole expense, for the Manufacture of the relevant Compound or Product, as applicable, until the Anticipated Supply Shortfall has been remedied.

  

	 	6.6.2	 If the Anticipated Supply Shortfall is for a Product that is distributed by both Merck and Samsung
(directly or through Third Parties), Samsung’s available supplies of such Product shall be allocated proportionately between Samsung and Merck in accordance with Samsung’s forecasted demand for countries outside the Territory and
Merck’s forecasted demand for the Territory. Samsung shall prepare its forecasts in good faith. Such forecasts shall cover at least the same time periods as the Rolling Forecasts Merck is required to provide under Section 6.3 and shall be
prepared on a comparable schedule as Merck’s. Samsung shall keep a record of its forecasts for purposes of any audit which may be required. In the event a shortfall occurs and Merck disputes the allocation between Samsung and Merck, the Parties
shall appoint an independent Third Party to audit the forecasts and to make a determination as to an appropriate allocation of the Product between the Parties based on their respective forecasts. The selection of the Third Party to perform the audit
and the terms pursuant to which it shall be carried out, including confidentiality restrictions, shall be mutually agreed to by the Parties if the need arises. The determination of such independent Third Party as to an appropriate allocation of the
Product shall be binding on the Parties absent manifest error. 

  

	 	6.6.3	 Samsung shall notify Merck promptly of any batch failure that is reasonably expected to result in
Samsung’s inability to meet the requested delivery dates in any purchase order from Merck. 

  

	6.7	 Quality Control Program. Samsung shall maintain a quality control program consistent with cGMPs, as
required by the applicable Regulatory Authorities in the Territory and, if different, the country in which the Product is Manufactured. If, in accordance with Section 6.1, Merck undertakes any aspect of Manufacturing of the Product, as to those
Manufacturing functions Merck shall maintain a quality control program consistent with cGMPs, as required by the applicable Regulatory Authorities in the Territory and, if different, the country in which such Manufacturing functions are performed.

  

	6.8	 Quality Agreement. The Parties agree that they shall, prior to delivery of any Product by Samsung to
Merck, execute a quality agreement which shall set forth the tasks to be performed by each Party with respect to the Manufacture, transportation, sampling, testing, retaining of samples, release, and stability testing of Product, as well as tasks
related to regulatory reporting, complaint handling, investigations, recalls, inspections and audits (the “Quality Agreement”). In the event of any discrepancy or inconsistency between the tasks provided in the Quality Agreement and
the terms of this Agreement, the terms of this Agreement shall govern. The Quality Agreement may not be interpreted or construed by either Party as amending or modifying in any way any terms of this Agreement. The Quality Agreement may be modified
or amended by the Parties in writing, providing that such modification or amendment shall not, and shall not be deemed or construed to, modify or amend the terms of this Agreement. 

 

	6.9	 Notification of Regulatory Inspections. Each Party shall provide a reasonable description to the other
Party of any inquiries, notifications or inspections by any Regulatory Authority with respect to any Product as set forth in the Quality Agreement. To the extent Merck responds to any such inquiries, notifications or inspections relating to the
Manufacture of any Product, Merck shall obtain Samsung’s written approval (not to be unreasonably withheld or delayed by Samsung) of Merck’s responses before submission of such responses. 

  
 28 

	6.10	 Inspections and Audits. Merck shall have the right to visit any Manufacturing facility for a Product for
the purpose of observing the Manufacturing, packaging, testing and storage of the Product, and to inspect for compliance with cGMPs and other applicable regulatory requirements (including environmental, health and safety requirements) as set forth
in the Quality Agreement; provided that with respect to visitation and inspection of any Third Party Manufacturing facility, Merck shall be entitled to participate in inspections and audits of such Third Party (a) only along with Samsung
and (b) only to the extent permitted under the applicable manufacturing contract between Samsung or its Affiliate and such Third Party manufacturer, and such right shall be subject to (i) the same requirements and/or limitations governing
such right in the applicable manufacturing contract between Samsung or its Affiliate and such Third Party manufacturer and (ii) the execution by Merck of any relevant confidentiality agreement required by the Third Party; provided
further that if such Third Party manufacturer is engaged after the Effective Date, Samsung shall ensure that Merck has the same rights to inspect and audit the Manufacturing facility of such Third Party manufacturer as Merck has with respect
to Samsung’s Manufacturing facilities under this Agreement. Merck’s right of inspection and audit under this Section 6.10 shall be limited to once in each Calendar Year during the Term with respect to each Manufacturing facility that
Manufactures one or more Products to be supplied to Merck; provided, however, that Merck may also inspect and audit the Manufacturing facility “for cause” (i) as needed for Merck to respond to a Regulatory Authority notice or
inquiry regarding Product or (ii) as set forth in the Quality Agreement. Each such inspection and audit by Merck shall (a) be carried out by a reasonable and limited number of employees of Merck who are bound by confidentiality and non-use obligations as provided in Section 4.1.7 and (b) last for a reasonable period of time, and generally no more than [* * *] Business Days. 

 

	6.11	 Shipment and Handling of Labeled and Packaged Product. Samsung shall ship each Product to Merck
accompanied by the documentation set forth in the Quality Agreement by physically delivering the Product FCA Manufacturing facility (Incoterms 2010). Samsung shall schedule shipping with a carrier designated and paid for by Merck and furnish a bill
of lading to Merck with respect to each shipment. For the purposes of this Agreement, “delivery” of a Product to Merck shall be deemed to occur, and title and risk of loss with respect to the Product shall pass to Merck, upon delivery of
the Product to such carrier FCA Manufacturing facility. 

  

	6.12	 Inspection and Storage of Products Delivered. Merck shall perform a label and identity check upon
receipt of Product at its facility and shall store the Product in accordance with the product Specifications. In addition, Merck shall inspect each shipment of Product as soon as practicable after receipt, and in any case within [* * *]
Business Days of its receipt of such shipment, for any loss or damage, and shall notify Samsung in writing within such time if it discovers that any loss or damage has occurred to the Product prior to receipt. Such loss or damage shall not be
Samsung’s responsibility, except to the extent such loss or damage has resulted from the failure of Samsung at the time of delivery to the carrier designated by Merck to have complied with applicable Specifications regarding packaging. If Merck
does not notify Samsung of a claim under this Section 6.12 within the [* * *] Business Day period referred to above, then the Product received by Merck shall be deemed to be free from any loss or damage (except any latent loss or damage
that was not, and could not have been, discovered by Merck within the above [* * *] Business Day period by the exercise of the degree of care then prevailing in the pharmaceutical industry, of which latent loss or damage Merck shall notify
Samsung in writing promptly upon discovery). 

  
 29 

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	6.13	 Failure of Product to Meet Specifications. If a Product delivered to Merck is determined not to meet the
applicable Specifications, then Samsung shall, at the election of Merck, either (i) replace such non-conforming Product as soon as reasonably practicable at no additional cost to Merck, or
(ii) refund or credit to Merck the Supply Price paid or payable for such non-conforming Product, together with any direct
out-of-pocket costs reasonably incurred by Merck in connection with the rejection of such non-conforming Product, including, but
not limited to, applicable shipping and return costs, or reasonable costs of destruction. Notwithstanding anything to the contrary contained in this Agreement, the remedies set forth in this Section 6.13 shall be the sole and exclusive remedies
for the failure of any Product supplied by Samsung to Merck hereunder to conform to the applicable Specifications, (a) except to the extent Samsung is required under Section 8.5 to indemnify Merck, its Affiliates and its or such
Affiliates’ respective directors, officers, employees and agents from and against any Liability to one or more Third Parties arising out of such failure, and (b) except that Merck may exercise its right of termination in accordance with
Section 10.3.1 if such failure constitutes a material breach by Samsung under Section 10.3.1(a). 

  

	6.14	 Complaints. Samsung and Merck shall give each other prompt notice of any complaints regarding the
Products as set forth in the Quality Agreement. This information shall be given to each Party’s Authorized Quality Representative. Subject to the indemnification provisions of Article 8, the Parties shall cooperate with each other to the extent
necessary by providing assistance with complaint investigation and written notification of its findings when complaints are received. 

ARTICLE 7 PAYMENT OF SUPPLY PRICE 
  

	7.1	 Booking of Revenue; Records; Payment of Supply Price. Merck shall book revenue for sales of the Products
throughout the Territory. Merck shall maintain records, in sufficient detail for accounting purposes and for the purposes of this Agreement (including, without limitation, the Supply Price True-up Mechanism),
which shall fully and properly reflect all work done and results achieved in the Commercialization of Compounds and Products by Merck. The Supply Price for each 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. Within the later of (i) sixty (60) days following the delivery of Product to a carrier designated by Merck and (ii) thirty (30) days
following the delivery of the invoice for such Product to Merck, Merck shall pay Samsung the Supply Price for such Product. 

  

	7.2	 Audits. 

 

	 	7.2.1	 Upon the written request of a Party (the “Requesting Party”) and not more than once in
each Calendar Year, the other Party (the “Audited Party”) shall permit an independent certified public accounting firm of nationally recognized standing selected by the Requesting Party and reasonably acceptable to the Audited
Party, at the Requesting Party’s expense, to have access during normal business hours to such of the records of the Audited Party as may be reasonably necessary to verify the accuracy of the Supply Price calculations, annual true-up adjustments and payments made pursuant thereto for any Calendar Year ending not more than [* * *] years prior to the date of such request. The accounting firm shall disclose to the Requesting Party only
(i) whether the Supply Price calculations, annual true-up adjustments and payments made pursuant thereto are correct or incorrect, (ii) the amount of any resulting discrepancy and (iii) the
basis for calculating such amount of discrepancy. No other information shall be provided to the Requesting Party. 

  
 30 

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	 	7.2.2	 If such accounting firm identifies a discrepancy made during the period audited, the appropriate Party
shall pay the other Party the amount of the discrepancy, together with interest thereon at the rate of [* * *] per annum for the period from the date such discrepancy became due (in the case of underpayment) or was paid (in the case of overpayment)
until the date of payment pursuant to this Section 7.2.2, within thirty (30) calendar days of the date the Requesting Party delivers to the Audited Party such accounting firm’s written report so concluding, or as otherwise
agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the Requesting Party; provided, however, that if such audit uncovers an underpayment by the Audited Party that exceeds [* * *], then the fees
of such accounting firm shall be paid by the Audited Party. The findings of such accounting firm shall be binding on the Parties absent manifest error. 

  

	 	7.2.3	 Each Party (the “Sublicensing Party”) shall include in each sublicense granted by it
pursuant to this Agreement a provision requiring the sublicensee to make reports to the Sublicensing Party, to keep and maintain records and to grant access to such records to the other Party’s independent accountant to the same extent required
of the Sublicensing Party under this Agreement. 

  

	 	7.2.4	 Upon the expiration of [* * *] months following the end of any Calendar Year, the Supply Price
calculations, annual true-up adjustments and payments made pursuant thereto for such Calendar Year shall be binding and conclusive upon both Parties, and both Parties and their Related Parties, Affiliates and
sublicensees (as applicable) shall be released from any liability or accountability with respect to the Supply Price calculations, annual true-up adjustments and payments made pursuant thereto for such
Calendar Year. 

  

	 	7.2.5	 The Requesting Party shall treat all financial information of the Audited Party and its Related Parties
or Affiliates and sublicensees (as applicable) subject to review under this Section 7.2 or under any sublicense agreement in accordance with the confidentiality and non-use provisions of Article 4 of this
Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the Audited Party and/or its Related Parties, Affiliates and/or sublicensees obligating the accounting firm to retain all such information in
confidence pursuant to such confidentiality agreement. 

  

	7.3	 Provision of Information by Merck. Upon Samsung’s written request, but no more than once per
Calendar Quarter, Merck shall provide such financial information and data relating to the Commercialization of the Products in the Territory (including reasonable details regarding the composition and categories of such financial information and
data) as Merck keeps in the ordinary course of business and as are reasonably necessary for Samsung to calculate royalties, including, without limitation, the Commercial Contribution-Based Royalty (as defined in the Biogen License Agreement),
payable to the licensor under the Biogen License Agreement and/or to verify such calculation to the licensor. 

  

	7.4	 Default Interest. Any amount that is not paid by a Party to the other when due under this Agreement
shall bear default interest at the rate of [* * *] per annum from the day following the due date until paid in full. 

  
 31 

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

 ARTICLE 8 REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION 

 

	8.1	 Representations and Warranties of each Party. Each Party represents and warrants to the other
Party that as of the Effective Date: 

  

	 	8.1.1	 it has the full right, power and authority to enter into this Agreement and to perform its obligations
hereunder; 

  

	 	8.1.2	 this Agreement 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 

  

	 	8.1.3	 this Agreement 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. 

 

	8.2	 Samsung Representations and Warranties. Samsung represents and warrants to Merck that as of the
Effective Date: 

  

	 	8.2.1	 it has the full right, power and authority to Develop the Products and to grant the licenses granted
under Article 3; 

  

	 	8.2.2	 it has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and
interest in the Samsung Patent Rights or Samsung Know-How, other than (i) a non-exclusive, royalty-free, fully paid-up
license granted to Biogen Idec Therapeutics Inc. under certain Samsung Patent Rights and Samsung Know-How pursuant to the Biogen License Agreement, (ii) a
non-exclusive, non-transferable, royalty-free, fully-paid-up license granted to Biogen Idec MA Inc. under certain Samsung Patent
Rights and Samsung Know-How pursuant to the Biogen Manufacturing Agreement for the purpose of enabling the licensee to fulfill its contract manufacturing obligations thereunder and (iii) a non-exclusive, non-transferable, royalty-free, fully-paid-up license granted to Samsung BioLogics Co., Ltd. under certain Samsung
Patent Rights and Samsung Know-How pursuant to the Samsung Manufacturing Agreement for the purpose of enabling the licensee to fulfill its contract manufacturing obligations thereunder; 

 

	 	8.2.3	 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; 

  

	 	8.2.4	 Samsung has disclosed to Merck all reasonably relevant information regarding the Samsung Patent Rights
and Samsung Know-How licensed under this Agreement, and the existence of any patent opinions relating thereto, which, in each case, Samsung actually possesses or knows as of the Effective Date; and

  

	 	8.2.5	 EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN SECTION 8.1, THIS SECTION 8.2 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 MERCK. 

  
 32 

	8.3	 Samsung Covenant. Samsung shall use Commercially Reasonable Efforts throughout the Term to identify any
Third Party Patent Rights claiming or covering any of the Compounds or Products, or the Development, Manufacture or Commercialization thereof, that may potentially hinder or restrict the Development, Manufacture or Commercialization of any Compound
or Product pursuant to this Agreement, and shall update Merck twice per Calendar Year (at regular intervals) with respect to the results of such activities, and if any such Third Party Patent Rights are found, its strategy for achieving freedom of
operation with respect to the Development, Manufacture and Commercialization of the Compounds and Products throughout the Territory pursuant to this Agreement. 

 

	8.4	 Merck Representations and Warranties. Merck represents and warrants to Samsung that as of the
Effective Date: 

  

	 	8.4.1	 it has the full right, power and authority to Commercialize the Products throughout the Territory and to grant
the licenses granted under Article 3; 

  

	 	8.4.2	 it has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in
the Merck Patent Rights or Merck Know-How; 

  

	 	8.4.3	 there are no claims, judgments or settlements against or owed by Merck, and no pending or threatened claims or
litigation against Merck, relating to the Merck Patent Rights or Merck Know-How; 

  

	 	8.4.4	 Merck has disclosed to Samsung all reasonably relevant information regarding the Merck Patent Rights and
Merck Know-How licensed under this Agreement, and the existence of any patent opinions relating thereto, which, in each case, Merck actually possesses or knows as of the Effective Date; and

  

	 	8.4.5	 EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN SECTION 8.1, THIS SECTION 8.4 AND
ELSEWHERE IN THIS AGREEMENT, NEITHER MERCK NOR ANY OTHER PERSON ACTING ON BEHALF OF MERCK 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. 

  

	8.5	 Indemnification by Samsung. Samsung shall indemnify and defend Merck, its Affiliates and its and
such Affiliates’ respective directors, officers, employees and agents from and against any Liabilities arising out of or relating to (i) Samsung’s breach of any of its representations, warranties, covenants and obligations in this
Agreement (including those relating to the Development and Manufacturing of the Products), (ii) Samsung’s or its Affiliate’s failure to comply with any applicable laws, rules or regulations, or (iii) Samsung’s or its
Affiliate’s willful misconduct or negligence. 

  

	8.6	 Indemnification by Merck. Merck shall indemnify and defend Samsung, its Affiliates and its and
such Affiliates’ respective directors, officers, employees and agents from and against any Liabilities arising out of or relating to (i) Merck’s breach of any of its representations, warranties, covenants and obligations in this
Agreement (including those relating to the Commercialization of the Products), (ii) Merck’s or its Related Party’s failure to comply with any applicable laws, rules or regulations, or (iii) Merck’s or its Related Party’s
willful misconduct or negligence. 

  
 33 

	8.7	 Indemnification Procedure. 

 

	 	8.7.1	 A Party entitled to indemnification under Section 2.5.4, 2A.3.4, 6.5.3, 8.5 or 8.6 (an
“Indemnified Party”) shall give prompt written notification to the Party from whom indemnification is sought (the “Indemnifying Party”) of the assertion by a Third Party of any Liabilities for
which indemnification may be sought (it being understood and agreed, however, that the failure by an Indemnified Party to give such notification shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except
and only to the extent that such Indemnifying Party is actually prejudiced as a result of such failure to give such notification). 

  

	 	8.7.2	 Within thirty (30) days after delivery of such notification, the Indemnifying Party may, upon
written notice thereof to the Indemnified Party, assume control of the defense of such Liabilities using counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not assume control of such defense, the Indemnified
Party shall control such defense at the expense of the Indemnifying Party. 

  

	 	8.7.3	 The Party not controlling such defense may participate therein at its own expense; provided that
if the Indemnifying Party assumes control of such defense and the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to the action,
suit, proceeding or claim constituting or giving rise to such Liabilities, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith; provided,
however, that in no event shall the Indemnifying Party be responsible for the fees and expenses of more than one counsel in any one jurisdiction for all Indemnified Parties. 

 

	 	8.7.4	 The Party controlling such defense shall keep the other Party advised of the status of such action,
suit, proceeding or claim and the defense thereof and shall consider in good faith recommendations made by the other Party with respect thereto. Such other Party shall provide such cooperation as may be reasonably requested by the Party controlling
such defense in connection with or in furtherance of such defense. 

  

	 	8.7.5	 The Indemnified Party shall not agree to any settlement of such action, suit, proceeding or claim
without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld or delayed. The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or claim or consent to any judgment in
respect thereof that does not include a complete and unconditional release of the Indemnified Party from all Liability with respect thereto or that imposes any Liability or obligation on the Indemnified Party without the prior written consent of the
Indemnified Party, which shall not be unreasonably withheld or delayed. 

  

	8.8	 No Consequential Damages; Damages Cap. Notwithstanding anything to the contrary contained in this
Agreement, except to the extent a Party is required to indemnify the other Party, any of its Affiliates or any of its or such Affiliates’ respective directors, officers, employees or agents from and against any Liability to one or more Third
Parties under Section 2.5.4, 2A.3.4, 6.5.3, 8.5 or 8.6, (a) in no event shall either Party, any of its Affiliates or any of its or such Affiliates’ respective directors, officers, employees or agents be liable under this Agreement for any
special, indirect, incidental, consequential, punitive or exemplary damages, whether in contract, warranty, tort, negligence, strict liability or otherwise, including loss of profits or revenue suffered by either Party, any of its Affiliates or any
of its or such Affiliates’ respective 

  
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directors, officers, employees or agents, and (b) in no event shall Samsung’s aggregate liability to Merck (whether in contract, warranty, tort, negligence, strict liability or
otherwise) for any claim in any manner related to this Agreement exceed the total amount paid to Samsung by Merck under this Agreement within the twelve (12) months prior to the time such claim is first asserted by Merck or such liability
arises (whichever occurs earlier). If such preceding twelve-month period for a claim overlaps with such preceding twelve-month period for another claim, Samsung’s aggregate liability to Merck for the latter of such claims shall not exceed
(x) the total amount paid to Samsung by Merck under this Agreement within the twelve months prior to the time such latter claim is first asserted by Merck or such liability arises (whichever occurs earlier) less (y) the smaller of
(A) the amount paid by Samsung to discharge its liability to Merck in respect of the former claim, multiplied by the ratio of the number of days in the above period of overlap over 365, and (B) the amount paid to Samsung by Merck under
this Agreement during the period of overlap between such two (2) twelve-month periods. 

  

	8.9	 Indemnification Payments and Supply Price True-up Mechanism. For the avoidance of doubt, no
indemnification payment made by a Party to the other pursuant to this Article 8 shall be reflected or taken into account in determining “Samsung Costs” or “Merck Costs” under and for the purpose of the Supply Price True-up Mechanism. 

 ARTICLE 9 INFRINGEMENT CLAIMS; THIRD PARTY PATENTS 

 

	9.1	 Infringement Claims Against Either Party. Each Party shall give the other Party written notice of
any claim or threatened claim by a Third Party for infringement of such Third Party’s Patent Rights, know-how, trade secrets or other intellectual property rights by the Manufacture, use, import, export
or sale of Compounds or Products (an “Infringement Claim”) within five (5) Business Days of its first knowledge of the claim or threatened claim (whether or not such Party seeks indemnification from the other
Party under Article 8 in respect of such Infringement Claim). Subject to, and except as otherwise provided in, the indemnification provisions of Article 8, each Party shall (i) be responsible for conducting, managing and controlling the defense
of any Infringement Claim brought against it using counsel of its choice and (ii) cooperate fully with the other Party, at the expense of the Party against which the relevant Infringement Claim has been brought, in an effort to defend against
any Infringement Claim, including pursuing an appeal. To the extent that the Infringement Claim relates solely to a manufacturing process employed by Samsung or any of its contract manufacturers in Manufacturing any Compound or Product, Samsung
shall be responsible for [* * *] of all Liabilities associated with such Infringement Claim and Merck shall be responsible for [* * *] of such Liabilities. For all other Infringement Claims, the Parties shall [* * *] Liabilities
associated with such Infringement Claim. Notwithstanding the foregoing, if (a) an Infringement Claim is brought against either Party or both Parties, (b) Merck desires to litigate such Infringement Claim but Samsung opposes such litigation
and desires to compromise or settle such Infringement Claim, and (c) Merck proceeds to litigate such Infringement Claim despite Samsung’s opposition, the Parties shall share equally all Liabilities associated with such Infringement Claim
even if it relates solely to a manufacturing process employed by Samsung or any of its contract manufacturers in Manufacturing any Compound or Product. For the purpose of this Article 9, the term “Liabilities” shall mean
(i) all fees and expenses of attorneys and other professional advisors, court costs and assessments, arbitration costs (including arbitrator fees and expenses), service and delivery charges, deposition costs, expert, witness, interpreter and
stenographer fees and related expenses, and other fees, costs and expenses incurred to defend (including filing one or more counterclaims or actions), compromise and/or settle the relevant Infringement Claim, (ii) all royalties, license fees
and similar fees payable pursuant to one or more license agreements entered into with a Third Party in settlement of or as a result of the relevant Infringement Claim, and (iii) all monetary damages and

  
 35 

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

	 	
losses and other liabilities for payment of money (other than those falling under clauses (i) and (ii) above) incurred as a result of or in connection with the relevant Infringement Claim.
Notwithstanding anything to the contrary contained in this Agreement, in the event that (a) an Infringement Claim is brought against either Party or both Parties, (b) Samsung desires to litigate such Infringement Claim but Merck opposes
such litigation and desires to compromise or settle such Infringement Claim, and (c) Samsung proceeds to litigate such Infringement Claim despite Merck’s opposition, Merck shall have the right, at its sole discretion, to terminate this
Agreement with respect to the Product involved in such Infringement Claim and with respect to the Region in which such Infringement Claim is brought, upon sixty (60) days’ written notice to Samsung. Such right of termination may be
exercised by Merck at any time within sixty (60) days (not thereafter) following receipt of written notice from Samsung that it intends to litigate the Infringement Claim despite Merck’s opposition. 

 

	9.2	 Third Party License. In the event that a Third Party approaches either Party with a
request or demand that such Party obtain a license under any Patent Rights or know-how owned or Controlled by such Third Party for purposes of the Development, Manufacture and/or Commercialization of any
Compound or Product, such Party shall notify the other Party in writing of such request or demand and the Parties shall discuss whether one or both of the Parties shall obtain such a license. In the event that either or both Parties obtain such a
license, all royalties, license fees and other similar fees incurred or paid for or in connection with such license, and all fees and expenses of attorneys and other professional advisors incurred or paid in relation thereto, shall be included in
“Samsung Costs” and/or “Merck Costs,” as applicable, under and for the purpose of the Supply Price True-up Mechanism (and thereby shall be borne by the Parties as set forth in Schedule
1.54). For the avoidance of doubt, nothing contained in this Section 9.2 shall, or shall be construed to, limit in any way the scope of royalties, fees and expenses covered by subpart (G) of “Samsung Costs” or by subpart
(C) of “Merck Costs” under and for the purpose of the Supply Price True-up Mechanism. 

  

	9.3	 Newly Issued Third Party Patent. In the event that a Party becomes aware of the issuance of a Third
Party patent (a “New Third Party Patent”) that is newly issued in a Region after the Effective Date and that, in the reasonable judgment of such Party’s legal counsel, may hinder or restrict the Development, Manufacture or
Commercialization of any Product (the “Affected Product”) pursuant to this Agreement, such Party shall promptly notify the other Party in writing of the issuance of such New Third Party Patent (the “Patent Issuance
Notification”). Upon receipt of the Patent Issuance Notification by such other Party, the Parties shall discuss in good faith their strategy regarding such New Third Party Patent. Notwithstanding anything to the contrary contained in
this Agreement, if the Parties fail to agree upon a strategy regarding such New Third Party Patent within [* * *] months following the receipt of the Patent Issuance Notification by such other Party, then either Party shall have the right to
terminate this Agreement with respect to the Affected Product in the Region in which such New Third Party Patent was issued, upon thirty (30) days’ prior written notice to the other Party. Such right of termination may be exercised by
either Party at any time within thirty (30) days following the expiration of the above [* * *] month period (and not thereafter). 

  

	9.4	 Sharing of Liabilities and Supply Price True-up Mechanism. For
the avoidance of doubt, no Liabilities incurred or paid by either Party in respect of an Infringement Claim pursuant to Section 9.1 shall be reflected or taken into account in determining “Samsung Costs” or “Merck Costs”
under and for the purpose of the Supply Price True-up Mechanism. 

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

 ARTICLE 10 TERM AND TERMINATION 

 

	10.1	 Term and Expiration. This Agreement shall be effective as of the Effective Date and, unless
terminated earlier pursuant to Section 10.2, 10.3, 10.4 or 10.5 or by mutual written agreement of the Parties, shall continue in full force and effect with respect to each Product in each Region for ten (10) years following the Launch of
such Product in such Region or such longer period of time as may be mutually agreed by the Parties in writing. This Agreement shall expire in its entirety upon its expiration with respect to all of the Products in all Regions. 

 

	10.2	 Termination by Merck on
Product-by-Product and Region-by-Region Basis. Notwithstanding anything
contained herein to the contrary, in the event that a particular 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, (a) 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 (b) 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.

  

	10.3	 Termination for Cause. 

 

	 	10.3.1	 Cause for Termination. This Agreement may be terminated at any time during the term of
this Agreement: 

  

	 	(a)	 upon written notice by a Party if the other Party commits a material breach of its obligations hereunder by
causes and reasons within its reasonable control and has not cured such breach within ninety (90) calendar days after notice requesting cure of the breach; provided, however, that in the event of a good faith dispute with
respect to the existence of a material breach, the ninety (90) day cure period shall begin from the time the dispute is finally resolved pursuant to Section 11.7; provided further that Samsung’s failure to supply or
deliver any Product meeting the requirements set forth in Section 6.1 to Merck in accordance with the terms of this Agreement shall be deemed to constitute a material breach only if Samsung, by causes and reasons within its reasonable control,
fails to deliver at least [* * *] of the quantity of such Product actually ordered by Merck pursuant to Sections 6.3 and 6.4 in each of any [* * *] consecutive Calendar Quarters and fails to deliver the applicable shortage to Merck within [* * *]
months after the end of such two (2) Calendar Quarter period; or 

  

	 	(b)	 upon written notice by a Party upon the filing or institution of any bankruptcy, reorganization, liquidation or
receivership proceedings in respect of the other Party, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, that in the case of any involuntary bankruptcy,
reorganization, liquidation or receivership proceeding such right to terminate shall only become effective if such other Party consents to the involuntary bankruptcy, reorganization, liquidation or receivership or such proceeding is not dismissed
within ninety (90) calendar days after the filing thereof. 

  
 37 

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

 In the case of termination of this Agreement under Section 10.3.1(a), the terminating
Party may terminate this Agreement in its entirety or, at the terminating Party’s sole discretion, if the material breach giving rise to its right of termination relates to a particular Product in a particular Region or in all Regions, only
with respect to such Product in such Region or in all Regions (as the case may be). 
  

	 	10.3.2	 Effect of Termination for Cause on License. If Samsung or Merck terminates this Agreement
in its entirety or only with respect to a particular Product in a particular Region or in all Regions under Section 10.3.1(a) or 10.3.1(b), the Parties’ licenses granted under Article 3 shall terminate with immediate effect with respect to
all of the Products in all Regions or only with respect to such particular Product in such particular Region or in all Regions, as the case may be, but without prejudice to any rights of the terminating Party to claim and recover from the other
Party monetary damages suffered in connection with or arising out of such termination (or the underlying material breach that is the cause of such termination). 

 

	10.4	 Termination Due to Infringement Claim or Newly Issued Third Party Patent. Merck shall have the
right to terminate this Agreement with respect to a particular Product in a particular Region in accordance with the terms of Section 9.1, and each Party shall have the right to terminate this Agreement with respect to a particular Product in a
particular Region in accordance with the terms of Section 9.3. 

  

	10.5	 Termination by Merck Based on the Result of Annual True-up.
Merck shall have the right to terminate this Agreement with respect to a particular Product in a particular Presentation on a Region-by-Region basis in accordance with
the terms of Section (c) of Schedule 1.54. 

  

	10.6	 Effect of Expiration or Termination; Survival. 

 

	 	10.6.1	 Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing
prior to such expiration or termination. Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination,
including without limitation the obligations to pay the Supply Price and make Merck’s True-up Payment or Samsung’s True-up Payment (each as defined in Schedule
1.54) with respect to all Products supplied by Samsung to Merck prior to such expiration or termination. 

  

	 	10.6.2	 Without limiting the generality of the foregoing sentences, in the event of termination of this
Agreement pursuant to Section 10.2, 10.3, 10.4 or 10.5 (whether in its entirety or only with respect to a particular Product in a particular Region or in all Regions), those portions of the Binding Forecast for Primary-Packaged Presentations
and the Binding Forecast for Secondary-Packaged Presentations that are outstanding as of the effective date of such termination, which are for the Product(s), Presentation(s) and Region(s) for which this Agreement has been so terminated (such
portions of such outstanding Binding Forecasts referred to herein collectively as the “Remaining Binding Forecasts” and individually a “Remaining Binding Forecast”), shall be treated as follows:

  
 38 

	 	(a)	 In the event that this Agreement is terminated by Merck under Section 10.2 or 10.3, Merck 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 Merck’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 Merck shall be entitled to retain any
Post-Termination Delivery Products of which Merck 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 “Merck Profit” and “Samsung Profit” for the purpose of calculating “Profit Differential” for the Final True-up Period under Schedule 1.54); 

  

	 	(b)	 In the event that this Agreement is terminated by Merck under Section 10.5 (i.e., pursuant to
Section (c) of Schedule 1.54), 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 Merck in accordance with the terms of this
Agreement, and Merck shall perform its obligations relating to the Remaining Binding Forecasts and such Post-Termination Delivery Products accordingly; provided that Merck shall return to Samsung (as soon as reasonably practicable after the
expiration of the three (3) month period referred to below) any Post-Termination Delivery Products of which Merck took delivery pursuant to this Section 10.6.2(b) and which have not been sold to a Third Party by three (3) months after
the end of the last Calendar Quarter covered by the 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 Merck (except that such Supply Price, and the Post-Termination Delivery Products for which such Supply Price is payable, shall be reflected and taken into account in determining “Merck
Profit” and “Samsung Profit” for the purpose of calculating “Profit Differential” for the Final True-up Period under Schedule 1.54); 

 

	 	(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 Merck in accordance with the terms of this Agreement, and Merck shall perform its obligations relating to
the Remaining Binding Forecasts and such Post-Termination Delivery Products accordingly; provided that Merck shall return to Samsung (as soon as reasonably practicable after the expiration of the three (3) month period referred to below)
any Post-Termination Delivery Products of which Merck took delivery pursuant to this Section 10.6.2(c) and which have not been sold to a Third Party by three (3) months after the end of the last Calendar Quarter covered by the 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

  
 39 

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

	 	
any accounting or payment obligations to Merck (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 “Merck Profit” or “Samsung Profit” for the purpose of calculating “Profit Differential” for the Final True-up Period under
Schedule 1.54); 

  

	 	(d)	 In the event that Merck chooses (under Section 10.6.2(a) above), or is required (under
Section 10.6.2(b) or 10.6.2(c) above), to receive delivery of any Post-Termination Delivery Products, Merck shall retain the right to Commercialize such Post-Termination Delivery Products and the obligation to take delivery of and pay for such
Post-Termination Delivery Products in accordance with the terms of this Agreement as if, solely for the purpose of and with respect to such Post-Termination Delivery Products (and not for any other purposes), this Agreement had not been so
terminated; provided, however, that for the purpose of the preceding sentence, immediately upon termination of this Agreement pursuant to Section 10.2, 10.3, 10.4 or 10.5, all of the licenses and Commercialization rights granted
by Samsung to Merck under Article 3 shall become non-exclusive with respect to the Post-Termination Delivery Products; and 

 

	 	(e)	 In the event that this Agreement is terminated by either Party under Section 10.4, (i) the Remaining
Binding Forecasts shall be automatically cancelled, and (ii) the Operational Costs associated with all Post-Termination Delivery Products covered by the Remaining Binding Forecasts shall be: (A) borne by Merck and paid to Samsung within
thirty (30) days following such termination if this Agreement is so terminated by Merck under Section 9.1 or 9.3 or (B) borne by Samsung if this Agreement is so terminated by Samsung under Section 9.3. For the avoidance of doubt,
in the event of termination by either Party under Section 10.4, under and for the purpose of the Supply Price True-up Mechanism, (i) no Post-Termination Delivery Products covered by the Remaining
Binding Forecasts so cancelled shall be included in determining “Supply Volume” and (ii) no Operational Costs paid by Merck to Samsung or borne by Samsung pursuant to this Section 10.6.2(e) shall be reflected or taken into
account in determining “Samsung Costs” or “Merck Costs.” 

  

	 	10.6.3	 In any event of termination of this Agreement (whether in its entirety or only with respect to a
particular Product in a particular Region or in all Regions), the Parties shall, without prejudice to their respective rights and obligations expressly set forth in this Agreement, exercise Commercially Reasonable Efforts to mitigate any costs and
expenses associated with such termination. 

  

	 	10.6.4	 In the event of (a) expiration of this Agreement with respect to a particular Product in a
particular Presentation in a particular Region or in all Regions under Section 10.1 or (b) termination of this Agreement with respect to a particular Product in a particular Presentation in a particular Region or in all Regions under
Section 10.5: (i) subject to Section 10.6.2, the Parties’ licenses granted under Article 3 with respect to such Product in such Presentation shall terminate as of such expiration or termination date solely in such Region or in all
Regions (as the case may be); (ii) each Party shall pay all amounts with respect to such Product in such Presentation and/or the Compound contained in such Product in such Presentation due and owing in such Region or in all Regions (as the case may
be) as of such expiration or termination date in accordance with the terms of this 

  
 40 

	 	
Agreement; and (iii) this Agreement shall remain in full force and effect with respect to all other Compounds, Products, Presentations and Regions for which this Agreement has not expired
pursuant to Section 10.1 or has not terminated pursuant to Section 10.5 (as the case may be). In the event of termination of this Agreement with respect to a particular Product in a particular Region or in all Regions under
Section 10.2, 10.3.1(a) or 10.4: (i) subject to Section 10.6.2, the Parties’ licenses granted under Article 3 with respect to such Product shall terminate as of such termination date solely in such Region or in all Regions (as the
case may be); (ii) each Party shall pay all amounts with respect to such Product and/or the Compound contained in such Product due and owing in such Region or in all Regions (as the case may be) as of such termination date in accordance with the
terms of this Agreement; and (iii) this Agreement shall remain in full force and effect with respect to all other Compounds, Products and Regions for which this Agreement has not terminated pursuant to Section 10.2, 10.3.1(a) or 10.4 (as
the case may be). Following the expiration and/or termination of this Agreement with respect to a Product in all of its Presentations and in all Regions, such Product shall cease to be a Product for purposes of this Agreement (including
Section 2.4). In the event that this Agreement has expired and/or terminated with respect to all of the Products in all Regions under this Article 10, this Agreement shall terminate in its entirety as of the expiration or termination date (as
the case may be) with respect to the last Product in the last Region. Upon such termination of this Agreement in its entirety, subject to Section 10.6.2, the Parties’ licenses granted under Article 3 shall terminate with respect to all of
the Products in all of their respective Presentations and in all Regions. 

  

	 	10.6.5	 The provisions of Article 4 shall survive the expiration or termination of this Agreement and shall
continue in effect for ten (10) years thereafter. In addition, any other provisions that, by nature, are intended to survive the expiration or termination of this Agreement, including, without limitation, the provisions of Article 1, Article 8
(except Section 8.3), this Article 10, Article 11 (except Section 11.2) and Sections 2.3, 2.5.4, 2A.3.4, 3.3, 3.7 (last two sentences only), 5.2 (only to the extent related to milestone license fees that have been paid or have accrued or
become payable prior to the expiration or termination of this Agreement), 5.3, 5.4, 6.3.6 (last sentence only), 6.4 (last sentence only), 6.5.3 (last sentence only), 6.9 (only to the extent related to inquiries, notifications or inspections made by
any Regulatory Authority prior to the expiration or termination of this Agreement), 6.11 (last sentence only), 6.12 (last two sentences only), 6.13, 6.14 (only to the extent related to complaints received by either Party prior to the expiration or
termination of this Agreement), 7.1 (second and fourth sentences only), 7.2 (except Section 7.2.3), 7.3, 7.4, 9.1, 9.2 (except the first sentence) and 9.4, shall survive any expiration or termination of this Agreement in accordance with their
respective terms. 

 ARTICLE 11 MISCELLANEOUS 
  

	11.1	 Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party,
potentially including, but not limited to, embargoes, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, unavailability or failure of public
utilities or common carriers, fire, floods, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party, provided that such act, event or condition was not the result of the fault or
negligence of the affected Party and that such Party has been unable to overcome such act, event or condition with the exercise of due diligence (including the expenditure of reasonable sums). The affected Party shall notify the other Party of such
force majeure circumstances as soon as reasonably practical, and shall promptly undertake all Commercially Reasonable Efforts necessary to cure such force majeure circumstances. 

  
 41 

	11.2	 Assignment; Change of Control. 

 

	 	11.2.1	 Except as provided in this Section 11.2, this Agreement may not be assigned or otherwise
transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the prior written consent of the other Party. 

  

	 	11.2.2	 Merck may, without Samsung’s consent, assign this Agreement and its rights and obligations
hereunder in whole or in part to an Affiliate of Merck (provided that Merck shall guarantee all monetary obligations of such assignee under or arising out of this Agreement, including, without limitation, any indemnification obligations of
such assignee under Article 8) or in connection with a Change of Control. Samsung may, without Merck’s consent, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate of Samsung (provided that
(i) if such assignee is an entity engaged primarily in contract-manufacturing of biopharmaceutical products, Samsung shall remain liable, on a joint and several basis with such assignee, for full performance of all of its obligations under this
Agreement, and (ii) in all other cases, Samsung shall guarantee all monetary obligations of such assignee under or arising out of this Agreement, including, without limitation, any indemnification obligations of such assignee under Article 8)
or in connection with a Change of Control. Each Party shall ensure that prior to any assignment permitted under this Section 11.2.2 the assignee agrees in writing, in form and substance reasonably satisfactory to the other Party, to perform and
comply with all obligations of the assigning Party under, and to be bound by the terms and conditions of, this Agreement as if such assignee were a direct party (i.e., the assigning Party) hereto. Notwithstanding the foregoing, in the event
that a Party (the “Change of Control Party”) undergoes a Competing Pharma Change of Control, this Agreement shall automatically be amended as follows, unless the other Party (the “Remaining Party”), at its sole
discretion, agrees otherwise in writing: 

  

	 	(a)	 The JSC shall be discontinued effective upon such Competing Pharma Change of Control; and

  

	 	(b)	 The Remaining Party shall have the right to require the Change of Control Party and the other party to such
Competing Pharma Change of Control to adopt reasonable procedures to be agreed upon in writing with the Remaining Party to prevent the disclosure of the Remaining Party’s Information beyond the Change of Control Party’s personnel having
access to and knowledge of the Remaining Party’s Information prior to the Competing Pharma Change of Control and to control the dissemination of the Remaining Party’s Information disclosed after the Competing Pharma Change of Control. The
purposes of such procedures shall be to strictly limit such disclosures to only those personnel having a need to know the Remaining Party’s Information in order for the Change of Control Party to exercise its rights and perform its obligations
under this Agreement and to prohibit the use of the Remaining Party’s Information for competitive reasons against the Remaining Party and/or its Affiliates or Related Parties (as applicable) or any Compounds or Products, including, without
limitation, the use of the Remaining Party’s Information for the development, manufacture or commercialization of any competing products. 

  
 42 

	 	11.2.3	 Any attempted assignment not in accordance with this Section 11.2 shall be void.

  

	11.3	 Use of Affiliates. Each Party shall have the right to exercise its rights and perform its obligations
under this Agreement either itself or through any of its Affiliates; provided that even if a Party performs its obligations under this Agreement through one or more of its Affiliates, such Party shall at all times remain liable for the full
and complete performance of such obligations. In addition, in each case where an Affiliate of a Party has an obligation pursuant to this Agreement or performs an obligation pursuant to this Agreement, such Party shall cause and compel its Affiliate
to perform such obligation and comply with the terms of this Agreement. 

  

	11.4	 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal
or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby unless the absence of such invalidated, illegal or unenforceable
provision(s) frustrates, or makes it commercially impractical to achieve, the purposes of this Agreement despite the replacement of such provision(s) with valid, legal and enforceable provision(s) pursuant to the last sentence of this
Section 11.4. The Parties shall in such an instance replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement and the original
intent of the Parties as expressed herein as closely as possible. 

  

	11.5	 Notices. All notices which are required or permitted hereunder shall be in writing and sufficient
if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified airmail or internationally-recognized express courier), sent by internationally-recognized express courier or sent by registered or
certified airmail, postage prepaid, return receipt requested, addressed as follows: 

  

			
	if to Samsung, to:	  	 Samsung Bioepis Co., Ltd.
 Chomdandaero 107

Yeonsu-gu, Incheon

Republic of Korea (Postal Code: 406-840)
  

Attention: Representative Director
 Facsimile No.: 82-32-455-6000

		
	and:	  	 Attention: Chief Financial Officer
 Facsimile
No.: 82-32-455-6100

		
	if to Merck, to:	  	 Merck Sharp & Dohme Corp.
 One Merck
Drive
 P.O. Box 100
 Whitehouse Station, NJ 08889-0100

USA
  

Attention: Chief Licensing Officer, WS2A-30

Facsimile No.: (908) 735-1214

		
	and:	  	 Attention: Office of Secretary, WS3A-65

Facsimile No.: (908) 735-1246

  
 43 

 or to such other address(es) as the Party to whom notice is to be given may have furnished
to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given on the day on which such notice is delivered to the recipient Party (or if so delivered on a
non-Business Day, then on the next Business Day). 
  

	11.6	 Applicable Law. This Agreement shall be governed by and construed in accordance with the laws of
the State of New York and the patent laws of the United States without reference to any rules of conflict of laws or renvoi. 

  

	11.7	 Dispute Resolution. 

 

	 	11.7.1	 The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy
or claim arising from or related to this Agreement or the breach thereof. If the Parties do not fully settle, and a Party wishes to pursue the matter, each such dispute, controversy or claim shall be finally resolved by binding arbitration in
accordance with the Arbitration Rules of the International Chamber of Commerce (“ICC”) in effect as of the date of commencement of the arbitration proceeding, and judgment on the arbitration award may be entered in any court having
jurisdiction thereof. 

  

	 	11.7.2	 The arbitration shall be conducted by a panel of three persons experienced in the pharmaceutical
business: within thirty (30) calendar days after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within thirty
(30) calendar days of their appointment. If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator within such thirty (30) calendar day period, the third arbitrator shall be appointed by the
ICC within ten (10) Business Days thereafter. The place of arbitration shall be London, England, and all proceedings and communications shall be in English. 

 

	 	11.7.3	 Either Party may apply to the arbitrators for any interim injunctive or provisional relief until the
arbitration award is rendered or the controversy is otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any interim injunctive or provisional relief necessary to protect
the rights or property of that Party prior to the commencement of the arbitration or pending the arbitration award. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory
damages. Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and any administrative fees of arbitration. 

 

	 	11.7.4	 Except to the extent necessary to confirm or enforce an award or as may be required by law, neither a
Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable
proceeding based on the dispute, controversy or claim would be barred by the applicable statute of limitations under the law governing this Agreement. 

  

	 	11.7.5	 The Parties agree that, in the event of a good faith dispute over the nature or quality of performance
under this Agreement, neither Party may terminate this Agreement until final resolution of the dispute through arbitration. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be
refunded if the arbitrators determine that such payments are not due. 

  
 44 

	11.8	 Entire Agreement; Amendments. This Agreement, together with the Schedules hereto, contains the
entire understanding of the Parties with respect to the Compounds and Products. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, with respect to the subject matter hereof are
superseded by the terms of this Agreement. The Schedules to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument
duly executed by authorized representative(s) of both Parties. 

  

	11.9	 Headings. The captions to the several Articles, Sections and subsections hereof are not a part of
this Agreement, but are merely for convenience to assist in locating and reading the several Articles, Sections and subsections hereof. 

  

	11.10	 Independent Contractors. It is expressly agreed that Samsung and Merck shall be independent
contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Samsung nor Merck shall have the authority to make any statements, representations or commitments of any kind, or to
take any action, which shall be binding on the other Party, without the prior written consent of the other Party. 

  

	11.11	 Waiver. The waiver by either Party of any right hereunder, or of any failure of the other Party
to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether of a similar nature or otherwise. 

 

	11.12	 Cumulative Remedies. Except as expressly provided in this Agreement, no remedy referred to in
this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under applicable law. 

 

	11.13	 Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in
connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply. 

 

	11.14	 Certain Conventions. Any reference in this Agreement to an Article, Section, subsection,
paragraph, clause or Schedule shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause or Schedule of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement
otherwise requires, (a) words of any gender include the other gender, (b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in
which such words appear, (c) words using the singular shall include the plural, and vice versa. 

  

	11.15	 Business Day Requirements. In the event that any notice or other action is required to be taken by a
Party under this Agreement on a day that is not a Business Day, then such notice or other action shall be deemed to be required to be taken on the next occurring Business Day. 

 

	11.16	 Further Actions. Each Party agrees to execute, acknowledge and deliver such further documents and
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 

  
 45 

	11.17	 Counterparts. This Agreement 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. After facsimile or electronic
transmission, the Parties agree to execute and exchange documents with original signatures. 

 [Signatures on the
Following Page] 

  
 46 

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

 

									
	SAMSUNG BIOEPIS CO., LTD.	 		  	MERCK SHARP & DOHME CORP.
					
	BY:	 	/s/ Christopher Ko                        	 		  	BY:	  	/s/ Kenneth C. Frazier                        
	NAME: Christopher Ko	 	                    	  	NAME: Kenneth C. Frazier
	TITLE: Representative Director	 		  	TITLE: Chairman, Chief Executive Officer & President

 SCHEDULE 1.41 

[* * *] 

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

 SCHEDULE 1.51 

[* * *] 

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

 SCHEDULE 1.54 

[* * *] 

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

 APPENDIX I TO SCHEDULE 1.54 

[* * *] 

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

 SCHEDULE 1.56A 

[* * *] 

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

 SCHEDULE 1.56B 

[* * *] 

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

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