Document:

EX-10.4

 Exhibit 10.4 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN 

THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED 

BECAUSE HORIZON THERAPEUTICS PLC HAS DETERMINED 

THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD 

LIKELY CAUSE COMPETITIVE HARM TO HORIZON 

THERAPEUTICS PLC IF PUBLICLY DISCLOSED. 

COMMERCIAL SUPPLY AGREEMENT 

(DRUG PRODUCT) 
 THIS COMMERCIAL SUPPLY
AGREEMENT (this “Agreement”) is entered into and effective this 18th day of November, 2018 (“Effective Date”) by and between Catalent Indiana, LLC (“Catalent”), an Indiana limited liability
company with offices at 1300 South Patterson Drive, Bloomington, Indiana 47403, and Horizon Pharma Ireland Limited (“Client”), a company incorporated under the laws of Ireland with offices at Connaught House, 1 Burlington
Road, Dublin 4, Ireland. In this Agreement, Catalent and Client each may be referred to individually as a “Party” and together as “Parties.” 

RECITALS 
 WHEREAS, Catalent is a leading
provider of advanced technologies, and development, manufacturing and packaging services, for pharmaceutical, biotechnology and consumer healthcare companies; 

WHEREAS, Client develops, markets and sells pharmaceutical products; 

WHEREAS, Client is the successor-in-interest to River Vision Development Corp.
(“River Vision”) and Catalent is the successor-in-interest to Cook Pharmica LLC (“Cook”) under that certain Commercial Supply Agreement
between River Vision and Cook dated July 7, 2016 (the “Prior CSA”); 
 WHEREAS, Client desires to have Catalent provide the Services
(as defined below) set forth in this Agreement and any Plan (as defined below), and Catalent desires to provide such Services, all pursuant to the terms and conditions in this Agreement; and 

WHEREAS, the Parties intend that this Agreement supersede and replace the Prior CSA as of the Effective Date. 

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, the Parties agree as follows: 

AGREEMENT 
  

	1.	 Definitions. For purposes of this Agreement, the following terms will have the meanings set forth below:

  

	 	1.1	 “Affiliate” means, (a) with respect to Client or any third party, corporation,
firm, partnership or other entity that directly or indirectly controls, is controlled by or is under common control with such entity; and (b) with respect to Catalent, Catalent, Inc. and any corporation, firm, partnership or other entity
controlled by Catalent, Inc. For the purposes of this definition, “control” means the ownership of at least 50% of the voting share capital of an entity or any other comparable equity or ownership interest. 

  

			
		  	
	CONFIDENTIAL	  	Page 1 of 48

	 	1.2	 “Applicable Laws” means, (a) with respect to Client, (i) cGMP and
(ii) all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which Bulk Drug Substance or Product is produced, marketed, distributed,
used or sold; and (b) with respect to Catalent, (i) cGMP and (ii) all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in
which Catalent Produces the Product. 

  

	 	1.3	 “Batch” means a specific quantity of a Product comprising a number of Units
mutually agreed upon between Client and Catalent, and that (a) is intended to have uniform character and quality within specified limits, and (b) is Produced according to a single manufacturing order during the same cycle of Production.

  

	 	1.4	 “Batch Record Package” has the meaning stated in the Quality Agreement.

  

	 	1.5	 “BLA” means a Biologic Licensing Application. 

 

	 	1.6	 “Bulk Certificate of Analysis” means a document certifying that Bulk Drug Substance
meets all Product Specifications and that the Bulk Drug Substance was manufactured in accordance with CGMPs. 

  

	 	1.7	 “Bulk Drug Substance” means the bulk form of the active ingredient identified in
the applicable Plan that is used in the Production of Product. 

  

	 	1.8	 “Business Review Committee” has the meaning set forth in Section 3.15.

  

	 	1.9	 “Catalent Confidential Process Information” means Catalent’s standard operating
procedures, In-Process Data and non-public information relating to Catalent Intellectual Property Rights. 

 

	 	1.10	 “Catalent Improvements” means an Invention that is created or conceived by Horizon
(whether solely or jointly with Catalent) and which is an improvement, enhancement or modification specific to any of Catalent’s proprietary processes, methods, techniques, materials or equipment for formulating, filling, inspecting, labelling
or testing biological products. 

  

	 	1.11	 “Catalent Intellectual Property Rights” means (a) all patent and any other
intellectual property rights owned or controlled by Catalent or its Affiliates as of the Effective Date; (b) those patent and any other intellectual property rights owned or controlled by Catalent or its Affiliates as of the Effective Date that
are further developed or refined in the course of Production; (c) Project Inventions and Catalent Improvements; and (d) those intellectual property rights that are developed by Catalent or its Affiliates outside the performance of the
Production 

  

			
		  	
	CONFIDENTIAL	  	Page 2 of 48

	 	and without the use of Client Confidential Information or Client Intellectual Property Rights and include without limitation, those which claim, cover or relate to any method, process,
know-how, trade secret or other technology owned or controlled by Catalent or its Affiliates that Catalent may incorporate or use in the course of performing the Production under this Agreement or the Prior
Agreement. 

  

	 	1.12	 “Catalent Project Product Code” means the identifying alphanumeric code established by
Catalent to identify the Product as set forth in the applicable Plan. 

  

	 	1.13	 “Certificate of Analysis” means a document, in the form attached to the Commercial
Product Plan, certifying that the Product has met all Product Specifications and the Product was Produced according to CGMPs. 

  

	 	1.14	 “Certificate of Compliance” means a document, in the form attached to the Commercial Product
Plan, certifying that the Product was manufactured and supplied in compliance with CGMP and such other criteria as identified on such document. 

  

	 	1.15	 “CGMP” means those current practices, as amended from time to time, related to the
manufacture of biopharmaceuticals and pharmaceuticals as set forth in the FDCA and its counterparts in the EU and such standards of good manufacturing practice as are required by the FDA, the EMA, and such other Regulatory Authorities (as defined
herein) as agreed in the applicable Plan, including those regulations set forth in the United States Code of Federal Regulations (Title 21, Parts 210-211), as such regulations may be amended or superseded.

  

	 	1.16	 “Client Confidential Information” means Client’s Confidential Information, which
for the avoidance of doubt shall include all information related to the Client Intellectual Property Rights and the Product, including the Bulk Drug Substance, the portions of the Process provided to Catalent by Client, and the Product
Specification, whether such Client Confidential Information is created, conceived, or developed by Client or its Affiliates (or on behalf of Client or its Affiliates by a third party) outside of the scope of the Services or by Catalent for Client in
the performance of the Services under this Agreement or the Prior CSA. 

  

	 	1.17	 “Client Insurance” has the meaning stated in Article 5. 

 

	 	1.18	 “Client Intellectual Property Rights” means (a) all patent and any other
intellectual property rights (including rights in data and other information) owned or controlled by Client or its Affiliates as of the Effective Date, including intellectual property which claim, cover or relate to the (i) Product, (ii) Client
Materials and/or (iii) a method or process relating to the Production of Product; (b) all patent and any other intellectual property rights (including rights in data and other information) created, conceived, developed or acquired by
Client or its Affiliates (or on behalf of Client or its Affiliates by a third party) outside of the scope of the Services, including performance of the Production, including intellectual property which claims, covers or relates directly to the
(i) Product, (ii) Client Materials and/or (iii) a method or process relating directly to the Production of the Product; and (c) all patent and any other intellectual property rights in all Product Inventions.

  

			
		  	
	CONFIDENTIAL	  	Page 3 of 48

	 	1.19	 “Client Materials” means the Bulk Drug Substance and Client-Supplied Components
for use in the Production supplied by Client to Catalent as outlined in the applicable Plan. 

  

	 	1.20	 “Client Trademarks” means the proprietary mark(s) for Product owned or controlled by
Client as stated in the applicable Plan. 

  

	 	1.21	 “Commercial Product Plan” means the document set forth in Exhibit A to this Agreement
setting forth information describing the Product and certain standard annexes that further describe activities and standard terms that apply to the Product (and any other applicable products) Produced for Client under the terms of this Agreement.
Any changes or additions to the Commercial Product Plan shall be made by written agreement of Catalent and Client. The Commercial Product Plan does not contain any commitment for a Batch. The Commercial Product Plan is incorporated into and forms a
part of this Agreement; provided that if there is any conflict between the Commercial Product Plan and the body of this Agreement, the body of this Agreement shall control unless the Commercial Project Plan expressly states the Parties’ intent
to supersede a specific term of the Agreement. 

  

	 	1.22	 “Component Specifications” means the Specifications for the Components set forth in the
applicable Plan including the testing, if any, to be performed for the Components, as set forth in such Plan. 

  

	 	1.23	 “Components” means all primary product-contact components (such as vials, plungers,
stoppers and syringes) or product-delivery devices (such as secondary devices or injectors) of the type required for Production. All Components will be specified and listed in the applicable Plan and may be identified as either Components supplied
by Client (“Client-Supplied Components”) and/or Components supplied by Catalent (“Catalent-Supplied Components”). 

  

	 	1.24	 “Confidential Information” of a Party (the “Disclosing Party”) shall
mean all information disclosed by or on behalf of the Disclosing Party to the other Party (the “Receiving Party”) or its Affiliates or its and their respective employees, subcontractors, suppliers, agents, distributors, licensees or
customers in connection with this Agreement or the Prior CSA or otherwise designated as the Disclosing Party’s Confidential Information hereunder. Confidential Information includes, without limitation, all information concerning the Process,
Product Specifications, Client Intellectual Property Rights, Catalent Intellectual Property Rights, Inventions, Price, and Services. The terms of this Agreement are both Parties’ Confidential Information. 

  

			
		  	
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	 	1.25	 “Damages” means any and all costs, losses, claims, actions, liabilities, fines,
penalties, costs and expenses, court costs, and fees and disbursements of counsel, consultants and expert witnesses incurred by a Party (including interest which may be imposed in connection therewith). 

 

	 	1.26	 “Dedicated Equipment” means the equipment, if any, identified in a Plan that is
purchased or otherwise provided by Catalent or Client and exclusively dedicated to use by Catalent in the provision of the Services. 

  

	 	1.27	 “Deliverables” means the data, results and materials generated from the performance of
the Services under this Agreement, including Batch records, Certificates of Analysis, Certificates of Compliance and drug history records. All Deliverables, excluding Catalent Confidential Process Information, will be deemed to be Customer
Confidential Information. 

  

	 	1.28	 “DMF” means Drug Master File, a confidential, detailed document submitted by Catalent
to the FDA which contains the chemistry, manufacturing, and controls (also known as “CMC”) information for a drug component or product, or similar document submitted to the EMA or other Regulatory Authority. 

 

	 	1.29	 “Effective Date” means the date of this Agreement as set forth above.

  

	 	1.30	 “EMA” mean the European Medicines Agency and any successor agency having substantially
the same functions. 

  

	 	1.31	 “EU” means the European Union and its member states, as constituted from time to time,
and in any event, shall also include the United Kingdom notwithstanding any change to its membership status within the European Union. 

  

	 	1.32	 “Facility” means the Catalent manufacturing facility located at 1300 South Patterson
Drive, Bloomington, Indiana 47403. 

  

	 	1.33	 “FDA” means the United States Food and Drug Administration and any successor agency or
entity that may be established hereafter. 

  

	 	1.34	 “FDCA” means the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), as
may be amended or superseded following the Effective Date. 

  

	 	1.35	 “Firm Order” means any of the following, each of which shall constitute a commitment by
Client to purchase and Catalent to Produce Product: (a) a Rolling Forecast which has been accepted by Catalent in accordance with Section 3.6.1; (b) a Purchase Order that has been confirmed in writing by Catalent and is intended by Client
to place an order for Product; or (c) an order for Product set forth in a Project Plan. For clarity, a Purchase Order that is issued by Client against the portion of a Rolling Forecast that meets the requirements of subclause (a) above or
a Project Plan shall be deemed to be a Firm Order, irrespective of whether Catalent expressly accepts or confirms such Purchase Order. 

  

			
		  	
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	 	1.36	 “Force Majeure” means causes beyond the reasonable control of a Party (or its
Affiliates, suppliers, public utilities, or common carriers) including, without limitation, acts of God (including but not limited to earthquake, tornado or hurricane), a change in laws or regulations, actions of any government or agency thereof
(other than arising from a failure to comply with Applicable Laws), war, terrorism, civil commotion, damage to or destruction of production facilities or materials, scientific or technical events, labor disturbances (where such labor disturbance is
not within the power of the affected Party to settle) and pandemic or epidemic events. 

  

	 	1.37	 “Indemnitee” has the meaning stated in Section 7.3 (“Procedure for
Indemnification”). 

  

	 	1.38	 “Indemnitor” has the meaning stated in Section 7.3 (“Procedure for
Indemnification”). 

  

	 	1.39	 “Initial Term” has the meaning stated in Section 10.1 (“Initial Term”).

  

	 	1.40	 “In-Process Data” means electronic files of IPC
(in-process control) and IPM (in-process monitoring) data. 

  

	 	1.41	 “Inventions” means all innovations, inventions, improvements, original works of
authorship, developments, concepts, know-how, data or trade secrets, whether or not patentable, created or conceived pursuant to the performance the Services conducted under this Agreement or the Prior CSA,
including the performance of the Production pursuant to a Plan. 

  

	 	1.42	 “MAA” means marketing authorization application. 

 

	 	1.43	 “Master Batch Record” means, with respect to each Presentation of Product to be
Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. 

  

	 	1.44	 “Nonconforming Product” has the meaning stated in Section 4.1 (“Product
Conformity”). 

  

	 	1.45	 “Non-Defaulting Party” has the meaning stated
in Article 10. 

  

	 	1.46	 “Party” or “Parties” has the meaning stated in the opening
paragraph. 

  

	 	1.47	 “Person” means a natural person, a corporation, a partnership, a trust, a joint
venture, a limited liability company, any governmental authority or any other entity or organization. 

  

	 	1.48	 “Plan” means a Commercial Product Plan or Project Plan, as applicable.

  

	 	1.49	 “Presentation” means the specific formula and Components used for a Product.

  

			
		  	
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	 	1.50	 “Price” has the meaning stated in Section 5.1 (“Product Price”).

  

	 	1.51	 “Process” means the process for the formulation, filtration, filling, lyophilization,
inspecting, labeling, packaging and testing of the Product using the Product Specifications in accordance with the Master Batch Record, including any improvements thereto from time to time made as a direct result of the Services during the Term of
the Agreement. 

  

	 	1.52	 “Process Consumables” shall mean materials used as an aid in the Production of Product
that do not become part of the finished Product including but not limited to filters, tubing, Product contact disposables, containers, and bags. 

  

	 	1.53	 “Produce” means to perform the Process, and “Production” has the
correlative meaning. 

  

	 	1.54	 “Producer Price Index” means the U.S. Bureau of Labor Statistics Producer Price Index.

  

	 	1.55	 “Product” means formulated Bulk Drug Substance, as listed in Appendix A, in syringes,
cartridges, and/or vials packaged as specified in the applicable Plan. 

  

	 	1.56	 “Product Availability Date” means the date that Product is to be made available by
Catalent to Client or its designated carrier in accordance with the Delivery Terms. 

  

	 	1.57	 “Product Invention” means any Invention that relates directly to the Product and uses
Client Materials. For the avoidance of doubt, a Product Invention shall include Inventions made solely by employees or contractors of Catalent, solely by employees or contractors of Client or its Affiliates, or jointly by employees or contractors of
Catalent and employees or contractors of Client or its Affiliates. All Product Inventions will be deemed to be Client Confidential Information. 

  

	 	1.58	 “Product Requirements” has the meaning stated in Section 4.1 (“Product
Conformity”). 

  

	 	1.59	 “Product Specifications” means, with respect to each Product, the Specifications
for the Product, and/or the stability program that are set forth in the Client-specific standard operating procedures and the Master Batch Records. The Product Specifications include all tests that Catalent is required to conduct or cause to be
conducted as specified in the applicable Product Plan. The Product Specifications may be modified from time to time only by a written agreement signed by Client and Catalent. 

 

	 	1.60	 “Project Invention” means any Invention created or conceived solely by Catalent that
relates to generally applicable methods for the formulation, filling, inspecting, labeling, packaging and testing of biological therapeutics, and that does not by necessity incorporate any Client Confidential Information or Client Intellectual
Property Rights, nor requires the use of Client Confidential Information. Project Inventions exclude all Product Inventions. 

  

			
		  	
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	 	1.61	 “Project Plan” means all document(s) labeled “Project Plan” that refer
to this Agreement, and that are signed by an authorized representative of each Party setting forth the proposed course of action for the Production of Product. A Project Plan may include, without limitation, a description of the Product, Components,
Regulatory Authorities and the countries where such Product will be used or sold, Presentations, Bulk Drug Substance, and pricing for Product(s) Produced and Services provided under this Agreement as set forth in Section 3.4.

  

	 	1.62	 “Purchase Order” means a form or document by which orders for Product, Raw
Materials, or Dedicated Equipment will be placed by Client; provided, however, that the terms and conditions of this Agreement shall be controlling over any terms and conditions included in any Purchase Order, confirmation or other documentation
exchanged by the Parties in connection with such Purchase Order, and any term or condition of such Purchase Order, confirmation or other documentation exchanged by the Parties in connection with such Purchase Order that is different from or contrary
to the terms and conditions of this Agreement shall be void. All Purchase Orders shall at a minimum specify (a) the quantity of Product ordered, and (b) requested Product Availability Dates, related to each Catalent Project Product Code. A
Purchase Order may also be issued in addition to an executed Project Plan (for example, as a means to facilitate Client’s invoicing and payment systems), but in such cases the absence of a Purchase Order shall not limit or be a condition of
either Party’s obligations to fulfill any commitments it has made in the Project Plan. 

  

	 	1.63	 “Quality Agreement” means the Quality Agreement for CGMP Products and Services between
Catalent and Client effective April 5, 2018, as may be amended from time to time. 

  

	 	1.64	 “Quality Disposition” means disposition of Product by Catalent’s Quality Assurance
department following Catalent Quality review of executed Batch documentation. 

  

	 	1.65	 “Raw Materials” means the materials used in the Production of the Product that may
become part of the finished Product such as active pharmaceutical ingredient/Bulk Drug Substance, excipients, media components, and buffer components. 

  

	 	1.66	 “Reckless Breach” means a Party’s failure, through act or omission, to perform a
material obligation specifically set forth in this Agreement or the Quality Agreement, in each case in reckless disregard of the consequences thereof, and such consequences directly affect the safety, identity, strength, purity, or quality of the
Product. 

  

			
		  	
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	 	1.67	 “Regulatory Approval” means all authorizations by the appropriate Regulatory
Authority necessary for commercial sale in a jurisdiction. 

  

	 	1.68	 “Regulatory Authority” means any national, state, provincial, or local or any
foreign or supranational government, governmental, regulatory or administrative authority, agency or commission of any court, tribunal or judicial or arbitral body. “Regulatory Authority” also includes any
non-governmental group licensed by an entity described in the preceding sentence to perform inspections, audits and/or reviews. 

 

	 	1.69	 “Rolling Forecast” has the meaning stated in Article 3. 

 

	 	1.70	 “Safety Data Sheet” or “SDS” is a document that contains information
on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product. It also contains information on the use, storage, handling and emergency procedures all related to the hazards of the material.

  

	 	1.71	 “Services” means all or any part of the activities, including the Production of Product
and/or regulatory services for Client, to be performed by Catalent (or any permitted subcontractor) pursuant to this Agreement as further described in the applicable Plan. 

 

	 	1.72	 “Specification(s)” means the tests, analytical procedures, and appropriate acceptance criteria
that are numerical limits or ranges that establish a set of criteria to which a raw material, component, drug substance or drug product must conform to be acceptable, as set forth in the Commercial Product Plan or, for development services, the
applicable Project Plan. 

  

	 	1.73	 “Supply Deficiency” means failure by Catalent to Produce and deliver the Batch (or
Batches) of Product specified in the relevant Firm Order. 

  

	 	1.74	 “Stock Items” means Raw Materials and Components that are used in the performance of
Services for Client, and services for other clients of Catalent, including without limitation standard vials, stoppers, and caps. For the avoidance of doubt, Stock Items are Catalent-Supplied Components. 

 

	 	1.75	 “Term” has the meaning stated in Section 10.1. 

 

	 	1.76	 “Termination Notice Period” has the meaning stated in Section 10.1.

  

	 	1.77	 “Testing Laboratories” means any third party instructed by Catalent and approved in
writing by Client to carry out tests on the Bulk Drug Substance and/or the Product. 

  

	 	1.78	 “Tests” means the tests to be carried out on the Product (or samples thereof) promptly
following delivery of the Product (or samples thereof) to Client, as stated in the applicable Plan. 

  

			
		  	
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	 	1.79	 “Testing Standards and Procedures” means, with respect to each Product Produced
hereunder, the written standards and procedures for evaluating compliance with the applicable Product Specifications, as mutually agreed upon in writing by Client and Catalent and incorporated in the applicable Plan. 

 

	 	1.80	 “Unit” means an individually packaged dosage form of a Product, including by way
of example only, a vial or prefilled syringe, as specified in the applicable Plan. 

  

	 	1.81	 “United States” means the fifty (50) states, the District of Columbia and all of
the territories of the United States of America. 

  

	2.	 Sourcing of Materials and Components. 

 

	 	2.1	 Delivery of Client Materials. Client, at Client’s sole expense, shall deliver or cause to be
delivered the Client Materials as specified in the applicable Plan, all to be delivered to Catalent at least [***] days in advance of the date set forth in the applicable Plan for Production of such Product. Except as may specifically be set forth
in the applicable Plan or the Quality Agreement, on receipt of the Bulk Drug Substance and Client-Supplied Components as set forth above, Catalent’s sole obligation with respect to evaluation of the Bulk Drug Substance and Client-Supplied
Components shall be to conduct identification testing and to review the accompanying Certificate of Analysis to confirm that the Bulk Drug Substance and Client-Supplied Components (if applicable) conform with the Product Specifications and Component
Specifications, respectively. 

  

	 	2.2	 Safety Data Sheet. Client shall provide Catalent a Safety Data Sheet for all Client-supplied chemicals
(including, if applicable, Bulk Drug Substance) and for each Product. Catalent shall notify Client of any unusual adverse health or environmental occurrence relating to the Product, including, but not limited to any claim or complaint by any
Catalent employee or third party that the operations of Catalent pursuant to this Agreement have resulted in any adverse health or safety effect on an employee or third party. Catalent and Client both agree to advise each other immediately of any
safety or toxicity problems of which it becomes aware regarding the Product. 

  

	 	2.3	 Catalent Obligations Relating to Client Materials. Catalent shall: 

 

	 	2.3.1	 at all times use [***] to keep the Client Materials secure and safe from loss or damage;

  

	 	2.3.2	 at all times store and handle the Client Materials under qualified conditions in a secured storage
location in accordance with Client’s handling and storage instructions and CGMP; 

  

	 	2.3.3	 use the Client Materials solely for the purpose of performing the Services; and 

  

			
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	 	2.3.4	 not transfer to a third party any part of the Client Materials or the Product, except to Affiliates and
permitted subcontractors as may be permitted in the Project Plan. 

  

	 	2.4	 Ownership and Risk of Loss; Client Materials and Product. Client shall own and continue to own all
right, title and interest in and to Client Materials. Except for liability arising from [***] assumes any and all risk of loss, damage, theft or destruction of Client Materials and Product while the Client Materials and Product are in
Catalent’s possession or on Catalent’s premises, and [***] with regard thereto in accordance with Section [***] of this Agreement. Upon termination or expiration of this Agreement, Client shall immediately notify Catalent whether Client
shall either (a) reclaim possession of Client Materials and Product; or (b) request destruction of Client Materials and Product by Catalent, each at Client’s sole expense. In the event Client fails to provide Catalent such notice
within [***] days following termination of this Agreement, Catalent shall notify Client in writing regarding the potential destruction of Client Materials and Product and then may destroy Client Materials and Product at Client’s sole expense if
Client does not within [***] business days following Client’s receipt of such notice request such Client Materials and/or Product be shipped to Client or its designee. Catalent shall invoice Client for all reasonable, documented out of pocket
costs incurred as a result of the return or destruction of the Client Materials and Product. 

  

	 	2.5	 Vendor and Supplier Audit and Certification. Catalent shall certify and audit all Product-related
vendors and suppliers of Catalent-Supplied Components, Raw Materials, and Process Consumables unless the responsibility for such certifications and audits is specifically assumed by Client under the applicable Plan. Client shall certify and audit
all vendors and suppliers of Client-Supplied Materials unless the responsibility for such certification and audits is specifically assumed by Catalent under the applicable Plan and Client shall pay for such audits as set forth therein.

  

	 	2.6	 Client-Supplied Components. Client shall supply to Catalent, or cause to be shipped to Catalent, all
Client-Supplied Components at Client’s expense. 

  

	 	2.7	 Catalent-Supplied Components. Catalent will use [***] to purchase the Catalent-Supplied Components with
sufficient lead times and in sufficient quantities to meet Client’s Firm Orders for Product, including additional quantities as necessary for efficient supply chain management practices. Catalent and Client shall review Catalent’s
inventory management plan as a routine part of joint governance of the Services in accordance with Section 3.15 (“Business Review Committee”). Client shall reimburse Catalent for the Catalent-Supplied Components as set forth in the
applicable Plan. Generation of invoices and payment for Catalent-Supplied Components shall be made in accordance with Section 5.3 (“Payment Terms”) of this Agreement. 

  

			
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	3.	 Purchase and Supply of Product; Performance of Services. 

 

	 	3.1	 Agreement to Purchase and Supply. Pursuant to the terms and conditions of this Agreement and the
applicable Plan, Client shall purchase from Catalent, on a non-exclusive basis, and Catalent shall use [***] to Produce and deliver to Client, the Product. A Firm Order shall constitute a commitment by Client
to purchase and Catalent to Produce Product, in each case subject to the terms and conditions of this Agreement and the applicable Plan. 

  

	 	3.2	 Performance. Catalent shall diligently perform the Production and other Services, including the
delivery of Deliverables and In-Process Data, as provided in the applicable Plan, and shall use [***] to achieve estimated schedules for the performance of Services and amounts of Product. Catalent shall
Produce Product and perform the Services in accordance with CGMP or any other Applicable Laws and in accordance with the Product Requirements, including the requirements set forth in the Quality Agreement with respect to applicable regulatory
requirements for commercial distribution in each of the Territories. Catalent shall not incorporate into any Product any Catalent Intellectual Property Rights or intellectual property rights of a third party. 

 

	 	3.3	 Reproduction, Rework or Reprocessing. If during the Production of any Batch of Product, any
reprocessing, rework, or reproduction is required in order to meet the Product Specifications, Catalent shall, at Catalent’s sole expense, conduct such reprocessing, rework, or reproduction in accordance with CGMPs and the BLA or MAA. Any
reprocessing, rework, reproduction, or change which is not covered by CGMPs and the BLA or MAA must be approved in writing by Client prior to implementation. To the extent such reprocessing, rework, reproduction, or change is required as a result of
the acts or omissions of Client, Client shall be responsible for, and promptly reimburse Catalent for all reasonable, documented costs and expenses incurred in connection with such reprocessing, rework, reproduction, or change.

  

	 	3.4	 Project Plans and Commercial Product Plans. 

 

	 	3.4.1	 Plans. For each Product to be Produced, or other Services to be performed, by Catalent hereunder, the
Parties shall execute one or more written Project Plan(s) and/or Commercial Product Plan(s) prior to commencement of any work or commitment by Catalent to purchase or supply any Services, Raw Materials or equipment, or reservation of production
capacity or schedule slots. Each Plan shall describe the Production and/or other Services with respect to the applicable Product and certain other relevant terms and conditions for performance of the Production and performance of Services by
Catalent under this Agreement. In no event shall Catalent be required to schedule the Production of any Product until a Plan for such Product has been approved in writing by both Catalent and Client. Each agreed upon Plan shall be incorporated
herein by reference. 

  

			
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	 	3.4.2	 Modification and Plan Scope Changes. From time to time, but no less often than [***] per quarter,
the Parties will meet to review and, if necessary, update, by mutual agreement, each Plan. In the event that the Parties agree to update, modify or expand the scope of a Plan, or to formally approve the accumulated minor project changes to a Project
Plan as set forth in the following Section, such amended Plan will become part of this Agreement in the manner stated in Section 3.4.1 upon execution of that Plan by an authorized representative of each Party. 

 

	 	3.4.3	 Minor Project Changes. The Catalent project manager shall maintain an ongoing log tracking all
Client-requested or Catalent-requested minor changes to the activities and items contained in an executed Project Plan. All such minor changes must be approved in writing by the Client and the Catalent project manager. Catalent is authorized to
implement (and invoice Client for) all such approved minor changes, provided that if the estimated total value of such tracked changes exceeds [***] percent ([***]%) of the total price of the Project Plan, then a formal Project Plan amendment must
be prepared, agreed to, and executed as set forth in the previous Section. For clarity, this Section 3.4.3 does not apply to any Commercial Product Plan, and any changes to a Commercial Product Plan must be agreed to in writing by Client.

  

	 	3.5	 No Amendment of Agreement. In the event that the terms of any Plan are inconsistent with the terms of
this Agreement, this Agreement shall control, unless otherwise explicitly agreed to in writing by the Parties. No Plan shall be deemed to amend this Agreement. Upon execution of any Plan, such plan shall be deemed to be incorporated herein and by
reference and made a part of this Agreement (subject to the first sentence of this Section). 

  

	 	3.6	 Forecasts, Orders and Capacity. 

 

	 	3.6.1	 Forecasts. Client may, at Client’s sole discretion, on or about the [***] day of each month,
provide to Catalent a written [***] month rolling forecast of Client’s estimated quantities for each Product (the “Rolling Forecast”), which shall, upon Client’s receipt of written notice of acceptance by Catalent, be
binding upon Catalent and Client, and shall constitute a Firm Order, as follows: 

 Until [***]: 

 

	 	3.6.1.1	 The first [***] months of the Rolling Forecast shall be firm and binding; 

  

			
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	 	3.6.1.2	 the next [***] months (or months [***] shall be partially firm and binding, with Client having the
ability to decrease the quantities therein by up to [***] percent ([***]%) or increase such quantities by up to [***] percent ([***]%); and 

  

	 	3.6.1.3	 the next [***] months (or months [***]) non-binding and solely
informational for Catalent’s planning purposes. 

 Beginning with [***]: 

 

	 	3.6.1.4	 The first [***] months of the Rolling Forecast shall be firm and binding; 

 

	 	3.6.1.5	 the next [***] months (or months [***] shall be partially firm and binding, with Client having the
ability to decrease the quantities therein by up to [***] percent ([***]%) or increase such quantities by up to [***] percent ([***]%); and 

  

	 	3.6.1.6	 the next [***] months (or months [***] non-binding and solely
informational for Catalent’s planning purposes. 

 Any Rolling Forecast that is not rejected in writing by Catalent
within [***] business days shall be deemed to have been accepted by Catalent. 
  

	 	3.6.2	 Purchase Orders. Unless a Purchase Order is submitted with respect to a Firm Order, Client shall not,
without the written consent of Catalent, designate a Product Availability Date in such Purchase Order earlier than [***] calendar days from the date Client submits the Purchase Order. For clarity, the Product Availability Date for Firm Orders as
described in Section 1.34(a) and (c) shall be as set forth in the corresponding Rolling Forecast or Project Plan, respectively. Upon acceptance of such Purchase Order by Catalent as set forth in Section 3.6.3, Catalent shall supply
Client with the quantity of Product ordered by Client by the Product Availability Date. Client will order full Batches based on the expected yield per Batch, as set forth in the applicable Plan. Each Purchase Order must include the requested
quantity, the Bulk Drug Substance availability date, the Catalent Project Product Code, Unit or Batch price, and Purchase Order total dollar amount. No other terms or conditions contained in any Client Purchase Order form(s) shall be binding on
Catalent. Upon Client’s receipt of Catalent’s confirmation in accordance with Section 3.6.3, such Purchase Order shall become a Firm Order. 

  

			
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	 	3.6.3	 Procedure for Acceptance of Purchase Orders. Within [***] business days following its receipt of a
Purchase Order that does not meet the definition of a Firm Order, Catalent shall, if the conditions above are met and Catalent has production capacity available to meet the requested Product Availability Date, provide a written confirmation of
acceptance of such Purchase Order setting forth the Product Availability Date for such order. No other terms or conditions contained in any Catalent confirmation or related documentation shall be binding on Client. With respect to Purchase Orders
that do not meet the definition of a Firm Order, upon Client’s receipt of the confirmation, and provided that such confirmation is issued within such [***] business day period, such Purchase Order shall become a Firm Order. For clarity,
Catalent’s confirmation or other formal acceptance is not required for a Purchase Order submitted with respect to a Firm Order and all such Purchase Orders shall be deemed to be accepted by Catalent. 

 

	 	3.6.4	 Delay. If Catalent is unable to meet the Product Availability Date (except when caused by Client’s
delay in delivery of Client-Supplied Materials or delays caused by a Component or Raw Material supplier) Catalent shall promptly so notify Client and provide to Client an alternative Product Availability Date which shall not be more than [***]
calendar days later than the initial Product Availability Date designated by Client in its Purchase Order. If Catalent does not provide an alternative Product Availability Date that is within that [***] period, Client may cancel, without liability
for any cancellation charges, the portion of the Firm Order that Catalent has indicated will not be delivered by the initial Product Availability Date. 

  

	 	3.6.4.1	 If Client requests a change in the Product Availability Date for a Batch due to forces beyond
Client’s control, such as a delay in the availability of Bulk Drug Substance, Catalent will use [***] to reschedule such Product Availability Date without charge to Client. 

 

	 	3.6.5	 Compensation for Unused Production Slot(s) Subject to Firm Order(s). 

 

	 	3.6.5.1	 If Client cancels any Firm Order (other than as set forth in Sections 3.6.4, 3.8.1.2, 4.5, 6.1.5, 7.5
and 10.2), Catalent will use [***] to fill any of Client’s unused production slots that are subject to such Firm Order with another customer’s product ordered subsequent to Client’s cancellation. If Catalent is unable to so fill such
production slot, then to compensate Catalent for the reserved production capacity and time slot(s) on Catalent’s production schedule, Client shall pay Catalent for all Products that are the subject of such Firm Order (other than Product subject
to Section 3.6.4, 3.8.1.2, 4.5, 6.1.5, 7.5 or 10.2) as set forth below in this Section 3.6.5, which shall be Catalent’s sole remedy and Client’s sole liability with respect to such cancellation. 

  

			
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	 	3.6.5.2	 Commencing [***] Client will pay Catalent for cancelled Batches as follows: 

 

			
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]

  

	 	3.7	 Storage. 

  

	 	3.7.1	 Raw Material and Component Storage. Catalent shall store Raw Materials and Components which are not
Stock Items for [***] full calendar months from receipt date of each item, without charge. On the first day of each calendar month thereafter that the Raw Materials and/or Components are stored by Catalent, Catalent shall invoice Client (and Client
shall pay) for [***] storage. In no event shall Catalent be required to store any Raw Material or Components for more than [***] days without Catalent’s written consent. For the avoidance of doubt, Catalent shall store Stock Items without
charge. 

  

	 	3.7.2	 Product Storage. Catalent shall store Products for the [***] which Catalent Quality Disposition for the
Products takes place, and for the [***], without charge. On the [***] thereafter that the Products are stored by Catalent, Catalent shall invoice Client (and Client shall pay) for [***] storage. In no event shall Catalent be required to store any
Products for more than [***] days without Catalent’s written consent. For purposes of this Section 3.7.2, storage by Catalent of any output from a manufacturing or development activity (such as an engineering batch) shall be subject to
storage fees as set forth herein. 

  

	 	3.7.3	 Storage Pricing and Off-Site Storage. Catalent shall be
permitted to store Product, Raw Materials, and Components in mutually acceptable (as confirmed by the Parties in writing) off-site, third party storage facilities. The applicable Plan may include pricing for
storage, and Client agrees to pay for such storage for as long as Product, Raw Materials or Components remain at Catalent’s facility or at a mutually acceptable off-site storage facility. If the
applicable Plan does not set forth storage charges, storage shall be charged at Catalent’s storage rates that are in effect at the time the storage occurs. 

  

			
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	 	3.8	 Supply Deficiencies. 

 

	 	3.8.1	 Supply Deficiency. If there is a Supply Deficiency, Catalent shall promptly notify Client in writing and
Catalent may, in its sole discretion, take one or more of the following steps: 

  

	 	3.8.1.1	 utilize suitable production capacity of Catalent or one of its Affiliates (provided that such Affiliate
is registered in the applicable BLA or MAA for the Product) not then committed to third party customers; and 

  

	 	3.8.1.2	 coordinate and cooperate with Client to reschedule Batches of Product ordered hereunder in order to
maximize Catalent’s ability to rectify the Supply Deficiency while minimizing the disruption to any Purchase Order and Firm Order then in force and any commitments to third party customers. Catalent shall notify Client in writing within [***]
business days of its initial notice of a Supply Deficiency of Catalent’s new proposed Product Availability Date for each affected order of Product, provided that if such date is not within [***] days of the original Product Availability Date
for such order, then Client may cancel such order by written notice to Catalent and shall no further obligation to Catalent with respect to such order or any unused production slots due to such cancellation. 

 

	 	3.8.2	 Exclusive Remedy. The provisions of this Section 3.8 (“Supply Deficiencies”) shall be the
sole liability of Catalent and sole remedy of Client with respect to any Supply Deficiency, except if the Supply Deficiency is the result of Nonconforming Product(s), in which case Client shall also have the remedies set forth in Article 4. Client
shall [***] the Production and/or Firm Order [***] the Production and/or Firm Order [***]. 

  

	 	3.9	 Changes in Manufacturing. 

 

	 	3.9.1	 Changes to Master Batch Records and Product Specifications. Catalent agrees to inform Client promptly
(but in any case not later than [***] days) of the result of any regulatory development or other required changes to Product Specifications that materially affect the Production of the Product. Catalent shall notify Client of and
require 

  

			
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	 	timely written approval from Client for changes to Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product. Provided that Catalent has provided Client with
at least [***] days prior written notice, failure of Client to respond in a timely manner may result in: (i) delay in the Product Availability Date; or (ii) loss of a Production slot in Catalent’s schedule; but in either case shall
not relieve Client of its obligations to pay Catalent for all activities described in the applicable Project Plan, including any lost Production slot. 

  

	 	3.9.2	 Product-Specific Changes. If facility, equipment, process or system changes are required of Catalent as
a result of requirements set forth by the FDA or any other Regulatory Authority, and such regulatory changes apply solely to the Production and supply of one or more Products, then Client and Catalent will review such requirements and, subject to
the Parties’ mutual agreement in writing to such regulatory changes, Client shall bear one hundred percent of the reasonable, documented costs thereof. 

  

	 	3.9.3	 General Changes. If such regulatory changes apply generally to one or more Products as well as to other
products Produced by Catalent for itself or for third parties, then, subject to the Parties’ mutual agreement in writing to such regulatory changes, Client shall pay a pro rata amount of the reasonable cost of such regulatory changes based upon
the proportion of time that Facility is dedicated to the Production of Products relative to the Production of such other products. 

  

	 	3.10	 Delivery Terms. Product shall be delivered to Client, or to a location designated by Client in the
Purchase Order, [***] designated by Client on the shipment request form or applicable Plan, at Client’s expense. [***] shall procure, at its cost, insurance covering damage or loss to the Product during shipping. Risk of loss and title for
Product shall pass to [***] of Product. 

  

	 	3.11	 Audit; Observation. 

 

	 	3.11.1	 [***] upon [***] days prior written notice, Client shall have the right to conduct an audit of that
portion of the Facility used in the Production during normal business hours. In the event there have been major quality issues with Product or Production, Client may reasonably require more frequent audits of the Facility. In addition, on reasonable
advance notice to Catalent, Client’s employees or representatives may be present at Catalent’s facilities to observe Catalent performing the Services. Notwithstanding the foregoing notice period, for purposes of confidentiality, safety and
to avoid the possibility of contamination, if a third party’s product is being manufactured during the time that Client intends to conduct an audit, 

  

			
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	 	such audit may be reasonably delayed upon prior written notice to Client. The form, participants and procedures of the audit shall be subject to Catalent’s reasonable prior approval. When conducting an audit, each
of Client’s representatives will (a) be subject to a nondisclosure obligation at least as restrictive as the obligations contained in Article 8 (“Confidentiality and Non-Solicitation of
Employees”); (b) follow such security and Facility access procedures as reasonably designated by Catalent; (c) be accompanied by a Catalent representative; (d) not enter areas of the Facility at times when any third party’s
products are being manufactured to assure protection of the Catalent Confidential Information or the confidential information of a third party; and (e) use [***] to avoid disrupting Catalent’s operations. In addition to an audit by Client,
Catalent agrees to reasonably cooperate with applicable Regulatory Authorities and shall permit Product-specific inspections by such Regulatory Authorities. 

  

	 	3.11.2	 On reasonable advance notice to Catalent, up to [***] of Client’s employees or representatives may
be present at Catalent’s facilities to observe Product Production or other performance of Services, subject to Catalent’s reasonable site rules and regulations. 

 

	 	3.12	 Recall. If Client is required to recall any Product because such Product may violate local, state or
federal laws or regulations, the laws or regulations of any applicable foreign government or agency or the Product Specifications, or in the event that Client elects to institute a voluntary recall, Client shall be responsible for coordinating such
recall. Client shall notify Catalent promptly if any Product is the subject of a recall and provide Catalent with a copy of all documents relating to such recall. Catalent shall cooperate with Client in connection with any recall, at Client’s
expense. Client shall be responsible for all of the costs and expenses of such recall. Notwithstanding the foregoing, in the event a recall, product withdrawal or field correction is necessary because [***], Catalent will bear the reasonable costs
associated with such recall, product withdrawal or field correction (including but not limited to costs associated with receiving and administering the recalled Product and notification of the recall to those Persons whom Client deems appropriate.
Catalent’s liability for costs associated with such recall, product withdrawal or field correction shall not exceed the maximum liability as set forth in Section 7.4. 

 

	 	3.13	 Dedicated Equipment. 

 

	 	3.13.1	 Selection and Procurement. Catalent shall select and, with Client’s prior written
approval, procure the Dedicated Equipment at Client’s sole cost[***]. Catalent shall use [***] to determine whether the Dedicated Equipment conforms to the applicable specifications and will work in the Facility for purpose stated in the
Project Plan. 

  

			
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	 	3.13.2	 Use and Storage of Dedicated Equipment. Catalent shall use and store the Dedicated Equipment only
in accordance with any written instructions prescribed by Client or the manufacturer of the Dedicated Equipment, and shall perform such routine maintenance and storage for the Dedicated Equipment as is reasonably required by such written
instructions and be reimbursed by Client for routine maintenance and storage as set forth in the applicable Plan. All costs for any extraordinary or non-routine maintenance that may be required will be
approved in advance by Client, and the applicable Plan will be revised to reflect any additional maintenance costs that may be required during the Term. Except: (i) in connection with such routine maintenance and storage, (ii) as required
by the Services; or (iii) as directed in writing by Client, Catalent shall not make any alterations, additions or improvements to the Dedicated Equipment. All alterations, additions or improvements made to the Dedicated Equipment will be at
Client’s sole cost and expense. 

  

	 	3.13.3	 Ownership and Risk of Loss; Disposition of Equipment. Client shall own and continue to own
all right, title and interest in and to any Dedicated Equipment. Client assumes any risk of loss, damage, theft or destruction of the Dedicated Equipment while that Dedicated Equipment is in Catalent’s possession or on Catalent’s premises.
Notwithstanding the foregoing, Catalent assumes any risk of loss damage, theft or destruction to the extent resulting from [***]. Upon termination or expiration of this Agreement, Client shall have the right and obligation to, upon reasonable
notice, reclaim possession of such Dedicated Equipment at its sole expense (including all costs of disconnection, removal, physical transfer and any subsequent reinstallation and requalification costs). Catalent shall reasonably cooperate with
Client to remove and return such Dedicated Equipment to Client in accordance with Client’s written instructions and shall invoice Client for: (i) direct costs incurred; and (ii) any damage other than reasonable wear and tear to the
Facility incurred as a result of the use and removal of the Dedicated Equipment. Notwithstanding the above, upon termination or expiration of this Agreement, Client may offer to sell to Catalent, or Catalent may offer to purchase from Client.
Neither Catalent nor Client, shall be obligated to make or accept such offers. In the event that Client has not removed the Dedicated Equipment within [***] days after Client’s receipt of Catalent’s written notice that the Dedicated
Equipment may be deemed to be abandoned, the Dedicated Equipment shall be deemed to be abandoned and Catalent may dispose of it or use it as it sees fit. 

  

			
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	 	3.14	 Product Testing and DMF. 

 

	 	3.14.1	 Testing. Catalent shall test, or cause to be tested by third party testing facilities audited by
Catalent and approved by both Parties, in accordance with the Product Specifications, each Batch of Product Produced pursuant to this Agreement before delivery to Client. A Certificate of Analysis for each Batch of Product delivered to Client shall
set forth the items tested by Catalent, specifications, and test results. Catalent shall send, or cause to be sent, such certificates along with one (1) copy of the Batch Record Package to Client prior to or at the same time of shipment of
Product to Client and within [***] calendar days after the date of fill if such Batch requires no investigations and/or additional testing. For the avoidance of doubt, Client is solely responsible for final release of each lot of the Product.

  

	 	3.14.2	 Stability Testing. At Client’s cost and expense, Catalent or a party selected by Client, may
perform all stability testing required to be performed on Production Batches of Product. If performed by Catalent, such testing shall be performed in accordance with the procedures set out in the Client-specific SOPs for the stability protocol and
the applicable Plan. 

  

	 	3.14.3	 Drug Master File. Catalent shall file and maintain the appropriate DMF and related reference
applications (e.g. Facility master file) for its Production of each Product hereunder in accordance with 21 CFR 314.420 and other Applicable Laws, as may be amended from time to time, at Catalent’s expense, and Catalent shall provide all needed
rights of reference to Client and its Affiliates and the FDA and the EMA. Catalent shall provide reasonable advance written notice to Client prior to amending any DMF that is referenced in a Client regulatory filing. 

 

	 	3.15	 Business Review Committee 

 

	 	3.15.1	 Promptly following the Effective Date, the Parties shall establish a business review committee
consisting of at least [***] representatives appointed by Client and at least [***] representatives appointed by Catalent (the “Business Review Committee”). The Parties shall appoint representatives to the Business Review Committee
who have appropriate experience and seniority and are authorized to make decisions on operational matters. A Party may exchange any or all of its representatives, and shall inform the other Party before such exchange by providing the names of its
new representatives on the Business Review Committee. 

  

			
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	 	3.15.2	 The Parties shall have a meeting of the Business Review Committee no less than [***] a year during the
first year after the Effective Date and no less than [***] a year during the following years. Any Party may ask for a meeting of the Business Review Committee if an important issue arises, which meeting shall be scheduled promptly.

  

	 	3.15.3	 The Business Review Committee shall discuss any quality, supply, purchasing, and any other issue arising
between the Parties relating to the performance of Services under Agreement. 

  

	 	3.15.4	 The Business Review Committee is entitled to make final decisions on all operational issues [***]. These
operational decisions are binding for both Parties. [***] 

  

	 	3.15.5	 If the resolution of an issue cannot be agreed upon by the members of the Business Review Committee,
then such issue shall be escalated to the appropriate senior executives of the Parties in accordance with Section 12.7. 

  

	 	3.15.6	 For the avoidance of doubt, the Business Review Committee shall have no authority to amend this
Agreement or to determine or waive compliance with any provision hereof. Any decisions of the Business Review Committee (or the senior executives to which an issue has been escalated) which constitutes a change of this Agreement is subject to
Section 12.6 of this Agreement. Therefore, decided changes cannot become effective before they are properly executed in an amendment pursuant to Section 12.6. 

 

	4.	 Nonconforming Product. 

 

	 	4.1	 Product Conformity. Within [***] calendar days from the date of shipment of both Product and the Batch
Record Package to Client, Client shall determine whether such Product conforms to Product Specifications and the Master Batch Record (collectively the “Product Requirements”). If Client believes any shipment of Product (or samples
thereof) do not conform to the Product Requirements (“Nonconforming Product”), then Client shall give Catalent written notice thereof as soon as practicable but in no event later than [***] calendar days from the date of shipment of
both Product (or samples thereof) and the Batch Record Package and shall, unless otherwise directed by Catalent, return the Product for further testing by Catalent. Failure to provide such written notice and return the Product for further testing by
Catalent shall constitute an irrevocable acceptance by Client of such Product and an admission that the Product meets Product Requirements, except as to any Latent Defect. If, after conducting its own testing, Catalent agrees, or it is determined
pursuant to Section 4.3 (“Disputes”), that the returned Product fails to meet Product Requirements 

  

			
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and, to the extent that such failure is not due (in whole or in part) to acts or omissions of Client before or after delivery of such Product or to a latent defect in a Component that was not
discoverable by the exercise of ordinary diligence and reasonable care, the provisions of Section 4.4 (“Nonconforming Product”) shall apply. 

  

	 	4.2	 Latent Defect. Client shall have [***] calendar days from the date of discovery of a defect in the
Product that could not have reasonably been discovered at the time of Delivery of the Product which the Client believes renders the Product Nonconforming (“Latent Defect”) to reject such delivered Product (in whole or in part) by
written notice thereof to Catalent, indicating the Client’s reason(s) for its belief that Product is Nonconforming Product. Such rejection [***]; provided that in no event shall Client reject any Product following the expiry date thereof. The
remedies for Product deemed to have a Latent Defect shall be as set forth in Section 4.4. For the avoidance of doubt, a defect that is caused by an event occurring after Delivery of the Product by Catalent shall not be deemed a Latent Defect.

  

	 	4.3	 Disputes. If there is any dispute concerning whether a Product (or a sample thereof) meets the Product
Requirements and/or the reasons therefor, the Parties shall designate an independent expert (acting as an expert and not as an arbitrator) to determine whether or not the Product at issue meets the applicable Product Requirements. The decision of
such independent expert shall be in writing and shall be binding on both Catalent and Client. The costs of such independent expert shall be borne by the Parties equally; provided, however that the Party that is determined to be incorrect in the
dispute shall be responsible for all such costs and shall reimburse the prevailing Party for its share of the costs incurred. 

  

	 	4.4	 Nonconforming Product. 

 

	 	4.4.1	 In the event a Product is determined to be Nonconforming Product (whether by agreement of Catalent
pursuant to Section 4.1 (“Product Conformity”) or by an independent expert pursuant to Section 4.3 (“Disputes”)), all such Nonconforming Product shall be either returned to Catalent or destroyed, at Catalent’s
option, and if elected in writing by Client, then Catalent shall replace such Nonconforming Product at its own cost and expense (excluding the cost of Bulk Drug Substance, other Raw Materials, and Components, subject to Section 4.4.3) and shall
use [***] to replace such Nonconforming Product in a reasonable time given any commitments to other Catalent clients or contractually obligated capacity constraints. 

 

	 	4.4.2	 If Client does not elect to have Catalent replace such Nonconforming Product, or if Client elects such
replacement and Catalent cannot replace such Nonconforming Product [***]. 

  

			
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	 	4.4.3	 In the event that such Nonconforming Product arises from [***], Catalent shall also pay, subject to
Section 7.4, the cost of the Bulk Drug Substance used to Produce such Product, irrespective of whether Client requests replacement of such Product and, if Client requests replacement of such Product the costs of the other Raw Materials and
Components required for such replacement. For clarity, nothing in this Section shall relieve Client of its obligation under this Agreement to pay for Product that meets the Product Requirements. 

 

	 	4.5	 Client Termination Right. In the event that Catalent delivers [***] Batches of Nonconforming Product
which nonconformance is not the result of (a) acts or omissions of Client or (b) nonconforming Client Materials or a latent defect in a Component that was not discoverable by the exercise of ordinary diligence and reasonable care, Client
shall have the right to immediately terminate this Agreement by giving notice to Catalent and shall have no liability to Catalent with respect to any Firm Orders cancelled in connection with such termination. 

 

	 	4.6	 Sole Remedy. The provisions of this Article 4 (“Nonconforming Product”) shall be the sole
remedies available to Client with respect to Product that fails to meet Product Requirements. For clarity, Catalent’s indemnification obligations under Section 7.2 shall remain in effect with respect to any such Product.

  

	 	4.7	 Non-Conforming Client Materials or Latent Defect in Components.
If Product does not meet Product Requirements and cannot be released by Catalent, or Product is rejected by Client, and such Product’s failure to meet the Product Requirements is the result of nonconforming Client Materials or a latent defect
in a Component that was not discoverable by the exercise of ordinary diligence and reasonable care, then such non-conformity shall not be deemed the result of the negligence or willful misconduct of Catalent.

  

	5.	 Price and Payment. 

 

	 	5.1	 Product Price. The price to be paid by Client for Product (“Price”) shall be set forth
in the Project Plan, and includes all Process steps and Catalent analytical support set forth in the Commercial Product Plan. No more than [***], Catalent may, at its sole discretion, increase the Price of any Product that is not covered by a Firm
Order as of the effective date of the Price increase. The Price increase shall not exceed [***] successor [***]. The Price shall be on a Batch basis. For clarity, the Price applicable to any Batch shall be the Price existing at the time that Client
places the Purchase Order for such Batch. 

  

			
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	 	5.2	 Cost Reimbursement. For all pass-through and out-of-pocket costs specified in the applicable Plan (which may include but is not limited to Raw Materials procured by Catalent, Catalent-Supplied Components, filters, containers, Product-contact
disposables, and Dedicated Equipment purchased by Catalent) Client shall reimburse Catalent, at Catalent’s cost [***]. 

  

	 	5.3	 Payment Terms. Catalent shall generate invoices for all fees and cost reimbursements. Invoices for
Product will be sent after Catalent’s Quality Disposition of each Batch of Product. Invoices for cost reimbursement will be sent not more than monthly and include reasonable documentation of costs incurred. Client shall pay all invoices (that
are not disputed in good faith) within [***] days of the date received by Client. Invoices not disputed within [***] days of receipt shall be deemed accepted and payment shall be made without deduction, deferment,
set-off, lien or counterclaim of any nature. Accepted invoices that remain unpaid more than [***] days beyond the scheduled payment due date may be subject to an interest charge equal to [***] percent ([***]%)
[***], calculated from the scheduled payment due date forward; provided that in no event shall such annual rate exceed the maximum interest rate permitted by Applicable Law in regard to such payments. Such payments when made shall be accompanied by
all interest so accrued. Payments may either be made by check or wire transfer of immediately available funds to the account as Catalent may designate from time to time. 

 

	 	5.4	 Regulatory Services Price. The price to be paid by Client for regulatory services shall be set forth in
a Project Plan. 

  

	 	5.5	 Default in Payment Obligations. In addition to all other remedies available to Catalent in the event of
a Client default, if Client fails to pay any undisputed invoice as required hereunder, Catalent may refuse all further Purchase Orders, refuse to Produce any Product until Client’s account is paid in full, modify the foregoing terms of payment,
place the account on a letter of credit basis, require full or partial payment in advance, suspend deliveries of Product until Client provides assurance of performance reasonably satisfactory to Catalent, and/or take other reasonable means as
Catalent may determine. The Parties shall seek to resolve any reasonable payment dispute promptly and in good faith. 

  

	 	5.6	 Insurance. 

  

	 	5.6.1	 Client Insurance. (a) Client shall maintain, during Client’s conduct of clinical trials with
respect to the Product, Clinical Trial Liability that shall cover amounts not less than [***] dollars ($[***]) per claim and in the aggregate, and (b) prior to the first commercial sale of the Product, Client shall procure and maintain, during
the Term of this 

  

			
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	 	Agreement and for a period [***], Commercial General Liability Insurance, including without limitation, Product Liability and Contractual Liability coverage (collectively (a) and (b), the “Client
Insurance”). The Product Liability coverage shall cover amounts not less than [***] dollars ($[***]) per claim and in the aggregate and shall be with an insurance carrier reasonably acceptable to Catalent. Catalent shall be named as an
additional insured on the Product Liability coverage and Client promptly shall deliver a certificate of Client Insurance and endorsement of additional insured to Catalent evidencing such coverage. [***] Any deductible and/or self-insurance retention
shall be the sole responsibility of Client. 

  

	 	5.6.2	 Catalent Insurance. Catalent is, and shall remain during the Term of this Agreement insured for the type
of liability that could arise under Section 7.2 (“Catalent Indemnification”) of this Agreement. Such insurance shall include products and completed operations liability insurance with a per occurrence limit of not less than [***]
United States Dollars ($[***]) or equivalent covering Catalent’s operations arising out of or connecting with this Agreement, providing coverage for bodily injury and property damage claims. Catalent shall be obligated to maintain product
liability insurance obtained by it pursuant to this Section during the Term and after expiration or termination of this Agreement for a period of [***]. Catalent shall provide evidence of such insurance to Horizon upon request.

  

	 	5.7	 Taxes. Unless otherwise indicated in writing by Catalent, all prices and charges are exclusive of any
applicable taxes, levies, import duties, Goods and Services Tax (GST), Value Added Tax (VAT), and fees of whatever nature, imposed by or under the authority of any governmental body, all of which shall be paid by Client (other than taxes on
Catalent’s net income). Indiana sales tax shall be charged on all applicable transactions unless Client has provided to Catalent a properly completed Indiana Exemption Certificate (Form ST-105). To the
extent that Client owns any personal property located at the Facility that is subject to property tax, Catalent may be obligated to report such property and Client shall be obligated to file and pay all applicable Monroe County, Indiana property
taxes. 

  

			
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	6.	 Representations and Warranties. 

 

	 	6.1	 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as
follows: 

  

	 	6.1.1	 Such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction
in which it is organized. 

  

	 	6.1.2	 Such Party (i) has the requisite power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. 

 

	 	6.1.3	 This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal,
valid, binding obligation, enforceable against such Party in accordance with its terms. 

  

	 	6.1.4	 All necessary consents, approvals and authorizations of all governmental authorities and other Persons
required to be obtained by such Party in connection with this Agreement have been obtained. 

  

	 	6.1.5	 The execution and delivery of this Agreement and the performance of such Party’s obligations
hereunder (i) do not conflict with or violate any requirement of Applicable Laws or regulations and (ii) do not conflict with, or constitute a default under, any contractual obligation of such Party. Catalent has informed Client, and
Client acknowledges, that Catalent is a US Government contractor and that in an emergency, Catalent may be obligated to give US Government production requirements over other production orders. If this occurs, it shall not be deemed a breach by
Catalent of its representations and warranties under this clause, or under any other section of this Agreement. [***]. 

  

	 	6.2	 Representations and Warranties of Client. Client further represents and warrants that:

  

	 	6.2.1	 [***], Client has lawful access to and the right to license or sublicense the Client Confidential
Information, Client Intellectual Property Rights and Client Materials to Catalent under and in accordance with the terms of this Agreement. 

  

			
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	 	6.2.2	 Client has not received any notice of infringement or misappropriation of any third party intellectual
property rights relating to the Client Confidential Information, Client Intellectual Property Rights and Client Materials used by Catalent under this Agreement and, to Client’s knowledge, Client is not subject to any claim of such infringement
or misappropriation. 

  

	 	6.2.3	 [***] each of the making, having made, use or importation of the Product, the Client Materials and/or
Catalent’s use of the Client Materials in accordance with the applicable Plan do not infringe or misappropriate any third party intellectual property rights. 

 

	 	6.2.4	 [***] the SDSs for the Client Materials are accurate and the Client Materials are free from all
contaminants including, without limitation, virus, bacteria or other vectors. Client will notify Catalent of any new safety or toxicity issues in accordance with Section 2.2. 

 

	 	6.3	 Representations and Warranties of Catalent. Catalent represents, warrants and covenants
that: (a) the Production shall be performed at the Facility in accordance with Section 3.2 (“Performance”); (b) the Product when made available at Catalent’s shipping docks in accordance with this Agreement and Client’s
instructions shall: (i) meet Product Specifications; (ii) be free from defects in material and workmanship; (iii) have been Produced in accordance with the Quality Agreement, CGMP and Applicable Laws; and (iv) shall not be
adulterated or misbranded within the meaning of the FDCA; and (c) [***] Catalent does not and shall not employ, contract with or retain any person directly or indirectly to perform Services under this Agreement if such person is debarred under
21 U.S.C. 335a (a) or (b) or other equivalent laws, rules, regulations or standards of any other relevant jurisdiction, and it will immediately disclose in writing to Client if any employee or agent is debarred, or if any action or
investigation is pending or[***] threatened, relating to the debarment of Catalent or any person performing services related to this Agreement; and (d) [***]. Catalent’s Production process does not infringe or misappropriate any third
party intellectual property rights and Catalent is not subject to any claim or notice of infringement or misappropriation of any third party intellectual property rights relating to its Production process. 

 

	 	6.4	 THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS SECTION 6 (“REPRESENTATIONS AND
WARRANTIES”) ARE EXPRESSLY IN LIEU OF AND EXCLUDE, AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS, ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE OR 

  

			
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ARISING FROM A COURSE OF DEALING OR USAGE OR TRADE PRACTICE, WITH REGARD TO ANY PRODUCT DELIVERED HEREUNDER, WHETHER USED ALONE OR IN COMBINATION WITH OTHER SUBSTANCES OR NON-INFRINGEMENT OF THE PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER PERSON. 

  

	7.	 Indemnification; Limitation of Liability; Waiver of Subrogation. 

 

	 	7.1	 Client Indemnification. Client shall indemnify, defend and hold harmless Catalent, its Affiliates, and
their directors, officers, employees and agents (collectively, “Catalent Indemnitees”) against any Damages, whether or not foreseeable or in the contemplation of Catalent or Client, that Catalent suffers as a result of any third
party claims, third party suits or third party actions arising from: (a) any breach of the representations and warranties set forth in Sections 6.1 (“Mutual Representations and Warranties”) and 6.2 (“Representations and
Warranties of Client”); (b) the distribution or use of the Product (including product liability or bodily injury with respect to the Product), except to the extent such loss, damage, costs and expenses are directly caused by Catalent’s
breach of Section 6.3 of this Agreement; (c) negligence (active, passive or imputed), gross negligence or willful misconduct of any Client Indemnitee in relation to the use, processing, storage or sale of the Product; or (d) any
claims by third parties alleging Catalent’s use of the Client Materials, Client Confidential Information, Client Intellectual Property Rights or the Product Specifications in accordance with this Agreement infringes any rights (including,
without limitation, any intellectual or other proprietary rights) of any third party (whether or not Client knew or should have known about such alleged infringement) except to the extent Catalent infringes any rights of any third parties by
application of Catalent’s Production techniques or any Catalent Intellectual Property Rights while performing the Services; in each case (a) – (d), except to the extent the Damages are a result of any Catalent Indemnitee’s negligence
(active, passive or imputed), gross negligence or willful misconduct or breach of this Agreement. 

  

	 	7.2	 Catalent Indemnification. Subject to the limitations set forth in Section 7.4(b), Catalent shall
indemnify, defend and hold harmless Client, its Affiliates, and their directors, officers, employees, and agents (collectively, “Client Indemnitees”) against any Damages, whether or not foreseeable or in the contemplation of Client
or Catalent, that Client suffers as a result of any third party claims, third party suits or third party actions arising from Catalent’s breach of Section 6.1 (“Mutual Representation and Warranties”) or 6.3 (“Representations
and Warranties of Catalent”); or (b) negligence (active, passive or imputed), gross negligence or willful misconduct of any Catalent Indemnitee, except to the extent the Damages are a result of: (a) any Client Indemnitee’s
negligence (active, passive or imputed), gross negligence or willful misconduct or breach of this Agreement; or (b) any claims by third parties alleging Catalent’s use of the Client Materials, Client Confidential Information, Client
Intellectual Property Rights or the Product Specifications in accordance with this Agreement infringes any rights (including, 

  

			
		  	
	CONFIDENTIAL	  	Page 29 of 48

	 	
without limitation, any intellectual or other proprietary rights) of any third party (whether or not Client knew or should have known about such alleged infringement) except to the extent
Catalent infringes any rights of any third parties by application of Catalent’s Production techniques or any Catalent Intellectual Property Rights while performing the Services. 

 

	 	7.3	 Procedure for Indemnification. A Party (the “Indemnitee”) that intends to claim
indemnification under Sections 7.1 (“Client Indemnification”) or 7.2 (“Catalent Indemnification”) shall promptly notify the other Party (the “Indemnitor”) of any claim, demand, action or other proceeding for
which the Indemnitee intends to claim such indemnification. The Indemnitor shall have the right to participate in, and to the extent the Indemnitor so desires, to assume the defense thereof with counsel selected by the Indemnitor; provided, however,
that the Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor, if representation of the Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between the Indemnitee and any other Party represented by such counsel in such proceeding. The indemnity obligations under Sections 7.1 (“Client Indemnification”) and 7.2 (“Catalent Indemnification”)
shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the prior express written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed.
The failure to deliver notice to the Indemnitor within a reasonable time after notice of any such claim or demand, or the commencement of any such action or other proceeding, to the extent prejudicial to its ability to defend such claim, demand,
action or other proceeding, shall relieve such Indemnitor of any liability to the Indemnitee under Sections 7.1 (“Client Indemnification”) and 7.2 (“Catalent Indemnification”) with respect thereto, and the omission so to deliver
notice to the Indemnitor shall not relieve it of any liability that it may have to the Indemnitee otherwise than under Sections 7.1 (“Client Indemnification”) and 7.2 (“Catalent Indemnification”). The Indemnitor may not settle or
otherwise consent to an adverse judgment in any such claim, demand, action or other proceeding that diminishes the rights or interests of the Indemnitee without the prior express written consent of the Indemnitee, which consent shall not be
unreasonably withheld or delayed. The Indemnitee, its employees and agents shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation and defense of any claim, demand, action or other proceeding covered by this
Section 7.3 (“Procedure for Indemnification”). 

  

	 	7.4	 Limitation of Liability.

 

	 	7.4.1	 IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR TO ANY THIRD PARTY UNDER THIS AGREEMENT
FOR ANY PUNITIVE DAMAGES OR INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS, BUSINESS OR REVENUE) EVEN IF ADVISED OR AWARE OF THE POSSIBILITY OF SUCH DAMAGES. 

  

			
		  	
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	 	7.4.2	 In addition, without prejudice or modification to the terms of Sections 7.1 (“Client
Indemnification”), 7.2 (“Catalent Indemnification”) and 7.3 (“Procedure for Indemnification”), the liability of each Party to the other Party, its permitted assigns and successors in interest, for any loss suffered by such
other Party or its permitted assigns and successors in interest, arising as a direct result of a breach of this Agreement, or of any other liability, including without limitation, misrepresentation and negligence (whether active, passive or
imputed), arising out of this Agreement and Production hereunder, including without limitation the production and/or supply of the Product, each Party’s liability shall be limited to the payment of Damages in an amount which shall not exceed an
amount equal to [***] for the Batch(es) that gave rise to the liability. Notwithstanding the above, in no event shall Catalent’s total aggregate liability per Product (regardless of presentation) in any calendar year for all claims of all types
exceed [***] dollars ($[***]) per Product (regardless of presentation) supplied under this Agreement. 

  

	 	7.4.3	 The limitations of liability set forth in this Section 7.4 will not apply to [***].

  

	 	7.5	 Abatement. Notwithstanding anything to the contrary in this Agreement, in the event that Production is
held, in a suit or proceeding, to infringe any intellectual property rights of a third party (or to constitute the misappropriation of a trade secret of a third party) and Production is enjoined, or Catalent has an objective basis (confirmed by an
opinion of its legal counsel) for believing that it is likely to be found to infringe or constitute a misappropriation, or is likely to be enjoined, then Catalent shall, at its option, either (i) procure the right to continue Production or
(ii) modify the Production so that it becomes non-infringing or no longer constitutes a misappropriation, provided that such modification has no adverse effect on Client hereunder; provided, however, that
if (i) and (ii) are not reasonably practicable, then either Party shall have the right, in its sole discretion, to terminate this Agreement by giving written notice to the other Party. The termination shall be effective [***] months after the
date the notice is given, provided that: (i) Catalent shall not be obligated to continue Production if Production is enjoined; and (ii) if Production is not enjoined and Client requests in writing that Catalent continue Production during
such [***] period, Client shall indemnify Catalent for any damages or expenses (including attorney fees) that Catalent incurs as a result of continuing the Production. In addition, if such infringement relates to the application of Catalent’s
Production techniques or any Catalent Intellectual Property Rights, then Client shall have no liability with respect to any orders cancelled in connection with such termination. 

  

			
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	 	7.6	 Waiver of Subrogation. All Catalent Supplied Components and equipment (other than Dedicated Equipment
owned by Client) used by Catalent in the Production of Product (collectively, “Catalent Property”) shall at all times remain the property of Catalent and Catalent assumes risk of loss for such property until delivery of
Product to a common carrier as specified under Section 3.10 (“Delivery Terms”). Catalent hereby waives any and all rights of recovery against Client, or against its directors, officers, employees, agents or representatives, for any
loss or damage to Catalent Property to the extent the loss of damage is covered by insurance (whether or not such insurance is described in this Agreement). Client assumes all risk of loss for all Client Materials supplied by Client, Dedicated
Equipment owned by Client, and all Product (collectively, “Client Property”), provided that such loss did not arise from [***]. Client hereby waives any and all rights of recovery against Catalent, or against its directors,
officers, employees, agents or representatives, for any loss or damage to the Client Property to the extent the loss of damage is covered by insurance (whether or not such insurance is described in this Agreement). 

 

	 	7.7	 Limitations an Essential Element of the Agreement. The Parties are willing to enter into this Agreement
only in consideration of and in reliance upon the provisions of this Agreement limiting their exposure to loss or liability. Such provisions are an essential part of the bargain underlying this Agreement and have been reflected in the pricing and
other consideration specified in this Agreement. Both Parties understand and agree that the exclusion of warranties, limitation of liability and the limitation of remedies allocate risks between the Parties as authorized under Applicable Laws.

  

	8.	 Confidentiality and Non-Solicitation of Employees.

  

	 	8.1	 Confidential Information. Each Receiving Party agrees that during the Term of this Agreement and
for a period of [***] years thereafter, it will keep the Confidential Information of the Disclosing Party secret and confidential, protect such Confidential Information with at least the same degree of care as it normally exercises to protect is own
Confidential Information of a similar nature, respect the Disclosing Party’s proprietary rights therein and make use of and permit to be made use of such information only as necessary to perform its obligations and exercise its rights under
this Agreement. The Receiving Party may not disclose or permit the Confidential Information of the Disclosing Party to be disclosed to any third party except as expressly provided herein without the Disclosing Party’s prior written consent.

  

	 	8.2	 Disclosure of Confidential Information. The Receiving Party shall grant access to the Confidential
Information of the Disclosing Party only to its Affiliates, subcontractors, suppliers, employees, consultants and contractors and, in the case of Client as the Receiving Party, partners and collaborators, who reasonably need to know such information
for purposes such Party’s exercise of its rights or performance of its obligations under this Agreement and who are subject to the written or otherwise legally enforceable obligations of confidentiality with respect to such Confidential
Information at least as stringent as those set forth herein. 

  

			
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	 	8.3	 Exceptions to Confidentiality. The obligations of Article 8 shall not apply to Confidential Information
to the extent that it: 

  

	 	8.3.1	 is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party in
breach of this Article 8, generally known or available; 

  

	 	8.3.2	 is known by the Receiving Party at the time of receiving such information or the generation of such
information hereunder, as shown by contemporaneous written records; 

  

	 	8.3.3	 is furnished after the Effective Date to the Receiving Party by a third party, without breach of and not
subject to any obligation of confidentiality; or 

  

	 	8.3.4	 is independently developed by the Receiving Party without use of or reference to Confidential
Information of the Disclosing Party, as shown by independent written records, contemporaneous with such development. 

Notwithstanding anything to the contrary in this Article 8, the Receiving Party may disclose the Disclosing Party’s Confidential
Information if it is required to be disclosed under any statutory, regulatory, stock exchange or similar legislative requirement or court order, provided, however, that (a) the Receiving Party gives the Disclosing Party prior written notice of
such required disclosure and assists the Disclosing Party in its [***] to prevent or limit such disclosure; and (b) the Confidential Information so disclosed otherwise remains the Confidential Information of the Disclosing Party for the
purposes of Article 8. 
  

	 	8.4	 Return of Confidential Information. Upon any expiration or termination of this Agreement, each Party
will use diligent efforts (including without limitation a diligent search of files and computer storage devices) to return or destroy all Confidential Information of the other Party and all copies, summaries, compilations, extracts or other
derivatives thereof, except to the extent such Confidential Information is necessary to exercise any right surviving termination of this Agreement. Additionally, each Party will be allowed to keep one archival copy of any Confidential Information of
the other Party solely for record keeping and for the purpose of determining its rights and obligations hereunder and subject to this Article 8. 

  

			
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	 	8.5	 Restrictions on Soliciting or Hiring Employees. During the Term of the Agreement and for [***] months
after the Agreement terminates or expires, neither Party shall knowingly, directly or indirectly, hire or employ any person who is an employee of the other Party during the Term (or was an employee of the other Party during the preceding
[***] months) and directly involved in the Production. Nothing in this Section shall prohibit a Party from hiring or employing candidates that respond to a general advertisement that is not targeted at the other Party’s employees.

  

	 	8.6	 Remedies. Each Party acknowledges and agrees that the other Party may not have an adequate remedy at law
for a violation of this Article 8 and therefore shall be entitled to seek enforcement of this Article 8 by temporary or permanent injunctive or mandatory relief obtained in any court of competent jurisdiction, and without prejudice to any other
rights and/or remedies which may be available to such Party at law or in equity. 

  

	 	8.7	 Use of Name. Except as set forth in Section 9.6 (“Trademarks”), neither Party shall use
the name or trademarks of the other Party, except to the extent that a Party is permitted to use the Confidential Information of the other Party or required to do so pursuant to this Article 8, without the prior written consent of such other Party,
such consent not to be unreasonably withheld. Notwithstanding the foregoing, Client may inform third parties that Catalent is the manufacturer and supplier of Product. Under no circumstances shall either Party state or imply in any promotional
material, publication or other published announcement that the other Party has tested or approved any product. 

  

	9.	 Intellectual Property. 

 

	 	9.1	 Disclosure. Subject to the obligations of confidentiality set forth in Article 8 (“Confidential
Information”), each Party shall disclose to the other Party any and all Inventions made pursuant to the activities undertaken relating to this Agreement at least quarterly or as may otherwise be agreed to in writing by the Parties.

  

	 	9.2	 Catalent Intellectual Property Rights. Catalent shall solely own all right, title and interest in and to
the Catalent Intellectual Property Rights. To the extent that the making, use, sale, or offer for sale, of the Product Produced hereunder or under the Prior CSA by or on behalf of Client or its Affiliates requires a license under the Catalent
Intellectual Property Rights, Catalent hereby grants a nonexclusive, royalty-free license under the Catalent Intellectual Property Rights to Client and its Affiliates to make, use, sell, or offer for sale and have such activities done on its behalf
(but not to have made or import) the Product and with no right to sublicense. Client shall not, without Catalent’s prior written consent, use the Catalent Intellectual Property Rights for any purpose other than as contemplated herein.

  

	 	9.3	 Client Intellectual Property Rights. Client shall solely own all right, title and interest in and
to the Client Intellectual Property Rights. Client hereby grants a nonexclusive, royalty-free, non-sublicenseable license under the Client Intellectual Property Rights (including the Client Confidential
Information and 

  

			
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Client Materials) to Catalent to the extent necessary to perform the Services. The foregoing license grant shall extend beyond termination or expiration of this Agreement solely as necessary for
Catalent to complete the Production of outstanding Purchase Orders and shall otherwise terminate upon termination or expiration of this Agreement. Catalent shall not, without Client’s prior written consent, use the Client Intellectual Property
Rights for any purpose other than the performance of Services as contemplated herein. 

  

	 	9.4	 Inventions. 

  

	 	9.4.1	 All Project Inventions and Catalent Improvements shall be owned by Catalent. To the extent that a
Project Invention or Catalent Improvement is patentable, Catalent shall have the right but not the obligation to file, prosecute and maintain any patents or patent applications claiming or covering any Project Invention. 

 

	 	9.4.2	 Client shall solely own all right, title, and interest in and to all Product Inventions and
Deliverables. Catalent hereby assigns, and to the extent not presently assignable shall assign, all right, title and interest in and to Product Inventions and Deliverables to Client. Client shall have the right but not the obligation to file,
prosecute and maintain any patents or patent applications claiming all Product Inventions. 

  

	 	9.4.3	 Each Party shall bear the expense of activities relating to its own filing, prosecution and maintenance
of any patent or patent applications provided for by this Section 9.4 (“Inventions”). Each Party shall execute all writings or take such acts, at the other Party’s expense, as may be reasonably required for either Party to fully
enjoy the rights and licenses granted pursuant to this Section 9.4 (“Inventions”). 

  

	 	9.4.4	 The Parties do not anticipate the joint conception or creation of any Inventions. In the event of any
jointly conceived or created Invention, other than a Catalent Improvement (which shall be subject to Section 9.4.1), the Parties shall discuss in good faith whether any patent application should be filed with respect to such Invention and the
Parties’ respective rights and responsibilities therefor. 

  

	 	9.5	 No Implied Licenses. Except as expressly set forth in this Agreement, nothing contained in this
Agreement shall be construed as granting, by implication, estoppel or otherwise, any licenses or rights under any patents or other intellectual property rights. Only licenses and rights granted expressly herein shall be of legal force and effect.

  

			
		  	
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	 	9.6	 Trademarks. 

  

	 	9.6.1	 Catalent License. Client grants to Catalent a non-exclusive,
royalty free license to use the Client Trademarks for the sole purpose of allowing Catalent to fulfill its responsibilities under this Agreement. Such license shall not be transferable in whole or in part. 

 

	 	9.6.2	 Client Ownership. Client shall be solely responsible for selecting, registering and enforcing the Client
Trademarks used to identify the Product and except as set forth in Section 9.6.1 (“Catalent License”) and shall have sole and exclusive rights in such Client Trademarks. 

 

	10.	 Term and Termination. 

 

	 	10.1	 Initial Term. This Agreement shall be effective on the Effective Date and shall continue for sixty
(60) months thereafter (the “Initial Term”), unless earlier terminated in accordance with the terms of this Agreement. This Agreement will be renewed automatically for two (2) additional twenty-four (24) month
periods commencing at the expiration of the Initial Term and any extensions thereof unless either the Client or Catalent terminates the Agreement by giving the other party written notice of intent to terminate at least twenty-four (24) months
prior to the expiration of the Initial Term or any extension thereof (the “Termination Notice Period”). The Initial Term as may be extended is referred to herein as the “Term.” 

 

	 	10.2	 Termination for Breach. 

 

	 	10.2.1	 Generally. Except as provided in Section 10.2.2 (“Exhaustion”), the failure by either
Party (the “Defaulting Party”) to comply with any of the Defaulting Party’s material obligations under this Agreement shall entitle the other Party (the “Non-Defaulting
Party”) to give to the Defaulting Party notice specifying the nature of the default and requiring the Defaulting Party to cure such default. If such default is not cured within fifteen (15) days (in the case of a payment default) or
thirty (30) days (in the case of a non-payment default) after the receipt of such notice (or, if such default reasonably cannot be cured within such period or if the Defaulting Party shall not commence
and diligently continue actions to cure such default during such period), the Non-Defaulting Party shall be entitled, without prejudice to any of the other rights conferred on it by this Agreement or available
to it at law, in equity or under this Agreement, to terminate this Agreement (and, if Client is the Non-Defaulting Party, any then-outstanding Firm Orders) by giving further notice to the Defaulting Party, to
take effect immediately upon delivery thereof. The right of either Party to terminate this Agreement, as provided in this Section 10.2.1 (“Generally”), shall not be affected in any way by its waiver or failure to take action with
respect to any previous default. 

  

	 	10.2.2	 Exhaustion. No default based on a claimed failure of any Product to conform to the Product
Specifications shall be the subject of a notice under Section 10.2.1 (“Generally”) until and unless all procedures and remedies specified in Article 4 (“Nonconforming Product”) shall have first been exhausted.
Furthermore, no inability by either Party to perform caused by an event of Force Majeure shall be the subject of a notice under Section 10.2.1 (“Generally”). 

  

			
		  	
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	 	10.3	 Termination for Insolvency. Subject to any limitations imposed by Applicable Laws, either Party shall
have the right to terminate this Agreement by giving notice to the other Party in the event that: 

  

	 	10.3.1	 Such other Party shall have: (i) voluntarily commenced any proceeding or filed any petition seeking
relief under the bankruptcy, insolvency or other similar laws of any jurisdiction, (ii) applied for, or consented to, the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for it or for
all or substantially all of its property, (iii) filed an answer admitting the material allegations of a petition filed against or in respect of it in any such proceeding, (iv) made a general assignment for the benefit of creditors of all
or substantially all of its assets, (v) become unable generally, or admitted in writing its inability, to pay all or substantially all of its debts as they become due, or (vi) taken corporate action for the purpose of effecting any of the
foregoing; or 

  

	 	10.3.2	 An involuntary proceeding shall have been commenced, or any involuntary petition shall have been filed,
in a court of competent jurisdiction seeking: (i) relief in respect of such other Party, or of its property, under the bankruptcy, insolvency or similar laws of any jurisdiction, (ii) the appointment of a receiver, trustee, custodian,
sequestrator, conciliator, administrator or similar official for such other Party or for all or substantially all of its property, or (iii) the winding-up or liquidation of such other Party; and, in each
case, such proceeding or petition shall have continued undismissed for sixty (60) days or an order or decree approving or ordering any of the foregoing shall have continued unstayed, unappealed and in effect for thirty (30) days.

  

	 	10.4	 Consequences of Termination. 

 

	 	10.4.1	 Payments Upon and After Termination. Upon expiration or termination of this Agreement Client shall pay
Catalent for all work completed subject to and in accordance with the terms of this Agreement and, if the Agreement was not terminated by Client pursuant to Section 10.2, all Firm Orders (including all binding Purchase Orders) that are in place
as of the date of termination. All such payments shall be made within [***] days of Client’s receipt of a correct invoice therefor from Catalent. For clarity, if Client terminates this Agreement pursuant to Section 10.2, then Client shall
have no liability to Catalent with respect to any orders cancelled in connection with such termination. Any payments to be made under this Section 10.4.1 shall be offset against any credits in Client’s account, and any amounts remaining
after such offset shall be promptly reimbursed to Client. 

  

			
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	CONFIDENTIAL	  	Page 37 of 48

	 	10.4.2	 Services During Termination Notice Period. Except if Catalent terminates this Agreement pursuant to
Section 10.2 or 10.3, during the Termination Notice Period, Catalent shall Produce all Product that is subject to all Firm Orders in accordance with this Agreement and deliver such Product to Client. For the avoidance of doubt, this Agreement
shall remain in full force and effect during the Termination Notice Period. 

  

	 	10.5	 Accrued Rights; Surviving Obligations. 

 

	 	10.5.1	 Accrued Rights. Termination or expiration of this Agreement for any reason shall be without prejudice to
any rights that shall have accrued to the benefit of either Party prior to such termination or expiration. Such termination or expiration shall not relieve either Party from obligations that are expressly indicated to survive termination or
expiration of this Agreement. 

  

	 	10.5.2	 Surviving Obligations. All of the Parties’ respective rights and obligations under
(a) Sections 1 (“Definitions”), 2.3 (“Catalent Obligations Relating to Client Materials”), 2.4 (“Ownership and Risk of Loss; Client Materials and Product”), 3.12 (“Recall”), 3.14 (“Product Testing
and DMF”), 4 (“Nonconforming Product”), 5.1 (“Product Price”), 5.2 (“Cost Reimbursement”), 5.3 (“Payment Terms”), 5.6 (“Insurance”), 6 (“Representations and Warranties”), 7
(“Indemnification; Limitation of Liability; Waiver of Subrogation”), 8 (“Confidentiality and Non-Solicitation of Employees”), 9 (“Intellectual Property”), 10.4 (“Consequences
of Termination”), 10.5 (“Accrued Rights; Surviving Obligations”), 11.7 (“Records”), 11.9 (“Ownership of Regulatory Filings”), and Article 12 (“Miscellaneous”) (except for Sections 12.12
(“Subcontracting”) through and including 12.16 (“Importer of Record”) of this Agreement, and (b) Sections 2 (“Overall Responsibilities”), 3 (“Definitions”), and Section 5 (“Specific
Responsibilities”) items 4.3, 4.10, 6, 8, 9, 11.2, 11.3, 14, 15 and 16 of the Quality Agreement shall survive termination, relinquishment or expiration of this Agreement. 

 

	 	10.5.3	 On or before the effective date of any termination or expiration, Catalent shall promptly transfer to
Client all compounds or other materials and supplies provided to Catalent by or on behalf of Client, including any Bulk Drug Substance, and all information in its possession and used in connection with the development and manufacture of the
Product.    Notwithstanding the above, Catalent may retain originals or copies (as the case may be) of information related to the manufacture of the Product for quality, regulatory, or record keeping purposes, subject to Article
8. 

  

			
		  	
	CONFIDENTIAL	  	Page 38 of 48

	11.	 Regulatory. 

  

	 	11.1	 Permits. Each Party shall be responsible, at its own expense, to obtain and maintain all permits and
licenses required for it to carry out its obligations hereunder. 

  

	 	11.2	 Regulatory Approvals. Client will advise Catalent of document requirements in support of NDA and/or BLA
and similar applications required of foreign governments and agencies that relate to the Services, including amendments, license applications, supplements and maintenance of such. Catalent will provide documents and assist Client in preparation of
submissions to Regulatory Authorities (both U.S. and foreign) designated by Client in support of Client’s NDAs and/or BLAs, similar applications required of foreign governments and licenses. All regulatory submission preparation and maintenance
performed by Catalent for Client shall be specified in a Project Plan or Commercial Product Plan for regulatory services. 

  

	 	11.3	 Compliance with CGMPs; Monitoring of Records. If and as required by a Project Plan, Catalent shall
monitor and maintain records respecting its compliance with CGMPs in the manner provided by the Quality Agreement, including the process of establishment and implementation of the operating procedures and the training of personnel as are reasonably
necessary to assure such compliance. 

  

	 	11.4	 Regulatory Authority Inspections. At Client’s request, Catalent will authorize Regulatory
Authorities to review related applications on Client’s behalf. Catalent will notify Client within [***] business days of all contacts with Regulatory Authorities (both written and verbal) related to each Product. Catalent shall inform Client of
the result of any regulatory inspection which directly affects the Production of a Product, including any notice of inspection, notice of violation or other similar notice received by Catalent affecting Production, Facility, testing, storage or
handling of a Product. In the event of an FDA inspection which directly involves a Product, Client shall be immediately informed of the issuance of the Notice of Inspection (FDA Form 482). In the event that there are inspectional observations (FDA
Form 483), Client shall be informed immediately and shall have the opportunity to review and provide Catalent with comments to Catalent’s response. Client shall provide its comments to the response of these observations within [***] business
days. The contents of Catalent’s response shall be determined by Catalent in its sole discretion. Catalent shall provide Client with a copy of Catalent’s response as provided to such Regulatory Authority as set forth in the Quality
Agreement. 

  

			
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	CONFIDENTIAL	  	Page 39 of 48

	 	11.5	 Regulatory Communications and Correspondence. Except as provided in Section 11.4 (“Regulatory
Authority Inspections”), any and all other communications from and to the FDA or other Regulatory Authorities related to the Production of the Product at the Facility shall be handled in accordance with the terms and conditions of the Quality
Agreement, or as otherwise agreed in writing by Catalent and Client. 

  

	 	11.6	 Regulatory Filings and Maintenance. Client shall be solely responsible for preparing and submitting to
the FDA all documents necessary for the Regulatory Approval of Product including adverse drug experience reports, field alert reports, periodic reports and applications for renewals, variations, supplements and amendments. Catalent shall prepare and
maintain all manufacturing files, certificates, authorizations, data and other records that directly pertain to the Production of the Product, as further set forth in the Quality Agreement or as otherwise agreed in writing by Catalent and Client.

  

	 	11.7	 Records. Catalent shall maintain the records required by the terms and conditions of the Quality
Agreement, or as otherwise agreed to in writing by Catalent and Client in a Project Plan. Catalent agrees that, in response to any complaint, or in the defense by Client of any litigation, hearing, regulatory proceeding or investigation relating to
the Production of Product, Catalent shall use [***] to make available to Client (during normal business hours and upon reasonable prior written notice) such Catalent employees and records as may be reasonably necessary to permit the effective
response to, defense of, or investigation of such matters, subject to appropriate confidentiality protections. Client shall reimburse Catalent for all reasonable, documented costs and expenses incurred by Catalent in connection with the performance
of Catalent’s obligations under the immediately preceding sentence, except to the extent that such litigation, hearing, regulatory proceeding or investigation arises from Catalent’s breach of this Agreement, gross negligence or willful
misconduct. 

  

	 	11.8	 Notification. Each Party shall promptly notify the other of new regulatory requirements of which it
becomes aware that are relevant to the Production of a Product under this Agreement and that are required by the FDA, any other applicable Regulatory Authority or other Applicable Laws or governmental regulations. The Parties shall confer with each
other with respect to the best means to comply with such requirements. 

  

	 	11.9	 Ownership of Regulatory Filings. Client shall be the sole owner of all regulatory filings and all
governmental approvals obtained by Client from any Regulatory Authority with respect to the Product. Notwithstanding the foregoing, and for the avoidance of doubt, all rights in and to Catalent Intellectual Property Rights and Catalent Confidential
Information shall remain entirely vested in Catalent. 

  

			
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	CONFIDENTIAL	  	Page 40 of 48

	12.	 Miscellaneous. 

 

	 	12.1	 Assignment. Neither Party may assign this Agreement without the prior written consent of the other
Party, which consent will not be unreasonably withheld. Notwithstanding the foregoing, either Party may, without the prior consent of the other Party, assign this Agreement to its Affiliate(s) or to the successor entity in connection with a merger
or acquisition, or to an entity acquiring substantially all of the product line or business operations of the assigning Party to which this Agreement pertains, provided that such Affiliate, successor or acquiring entity will expressly assume in
writing the obligation to perform in accordance with the terms and conditions of this Agreement. Any purported assignment not in compliance with this Section 12.1 (“Assignment”) shall be void. 

 

	 	12.2	 Severability. If any item or provision of this Agreement shall to any extent be invalid or
unenforceable, it shall be severed from this Agreement, and the remainder of the provisions of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and shall be enforced to the fullest extent
permitted by Applicable Law, and the Parties will negotiate in good faith to modify the Agreement to preserve (to the extent possible) their original intent,. 

 

	 	12.3	 Notices. Any consent, notice or report required or permitted to be given or made under this Agreement by
one of the Parties hereto to the other shall be in writing, delivered personally or by internationally recognized express courier, such as Federal Express or DHL, postage prepaid (where applicable), addressed to such other Party at its address
indicated below, or to such other address as the addressee shall have last furnished in writing to the address or in accordance with this Section 12.3 (“Notices”) and (except as otherwise provided in this Agreement) shall be effective
upon receipt by the addressee. 

 If to Catalent: 

Catalent Indiana, LLC 
 1300
South Patterson Drive 
 Bloomington, Indiana 47403 

Attention: [***] 
 E-Mail: [***] 
 With a copy to: 

Catalent Pharma Solutions, LLC 

14 Schoolhouse Road 
 Somerset,
NJ 08873 
 Attention: [***] 

E-Mail: [***] 

  

			
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	CONFIDENTIAL	  	Page 41 of 48

					
	                	  	If to Client:	  	Horizon Pharma Ireland Limited
		  		  	Connaught House
		  		  	1 Burlington Road, Dublin 4
		  		  	Ireland
		  		  	Attention: [***]
		  		  	E-Mail: [***]

 With a copy to: 

Horizon Pharma, Inc. 
 150 S.
Saunders 
 Lake Forest, Illinois 

United States of America 
 Attn:
General Counsel 
 Tel:[***] 

E-Mail: [***] 
  

	 	12.4	 Governing Law. The Agreement shall be governed by and construed in accordance with the laws of the
[***]. 

  

	 	12.5	 Venue, Jurisdiction. Any action or proceeding brought by either Party seeking to enforce any provision
of, or based on any right arising out of, this Agreement must be brought against either Party in the courts of the State of Delaware. Each Party (a) hereby irrevocably submits to the jurisdiction of the state courts of the State of Delaware and
to the jurisdiction of any United States District Court in the State of Delaware, for the purpose of any suit, action, or other proceeding arising out of or based upon this Agreement or the subject matter hereof brought by any Party or its
successors or assigns, (b) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action, or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named
courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action, or proceeding is improper or that this Agreement or the subject
matter hereof may not be enforced in or by such court, and (c) hereby waives and agrees not to seek any review by any court of any other jurisdiction that may be called upon to grant an enforcement of the judgment of any such Delaware state or
federal court. 

  

	 	12.6	 Entire Agreement. This Agreement and the Quality Agreement constitutes the entire and exclusive
agreement between the Parties with respect to the subject matter hereof and supersedes and cancels all previous discussions, agreements, representations, commitments and writing in respect thereof, including the Prior CSA. For clarity, such
termination of the Prior CSA does not release either Party from any liability or obligation, or affect either Party’s rights or remedies, accruing thereunder prior to the Effective Date. No amendment or addition to this

  

			
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	CONFIDENTIAL	  	Page 42 of 48

	 	
Agreement shall be effective unless reduced to writing and executed by an authorized representative of each Party. In the event of a conflict between the provisions of this Agreement and the
provisions of any exhibits or attachments hereto, including any Plan, the provisions of this Agreement shall govern. 

  

	 	12.7	 Attempts to Amicably Resolve Disputes. 

 

	 	12.7.1	 To avoid litigation and to resolve any conflicts that arise during the performance of the Services or
thereafter, Catalent and Client agree that, prior to the commencement of litigation by either Party, the Parties shall engage in executive mediation. Either Party may seek executive mediation by delivering a written request for such mediation to the
other. Delivery of such request may be made by hand or by electronic mail. The request shall be addressed to the following individuals: 

Catalent: [***] 
 Client: [***]

  

	 	12.7.2	 Within [***] business days of the delivery of such request, each Party shall appoint a company executive
who is not directly involved in the dispute to meet with the other Party’s company executive for the purpose of resolving the dispute. No later than [***] business days of their appointment, the two executives shall meet to consider the
dispute. They may request such information as either deems necessary and may meet jointly or separately with party representatives involved in the dispute. The two appointed executives shall use good faith efforts to reach a resolution of the
dispute. 

  

	 	12.7.3	 If a resolution is reached, it shall be reduced to writing and shall be final and binding on the
Parties. 

  

	 	12.7.4	 If the two executives cannot reach agreement within [***] business days of their initial meeting, unless
the two executives agree to additional review time, either Party may thereafter pursue any remedy at law or in equity. 

  

	 	12.7.5	 Notwithstanding anything herein to the contrary, each Party shall have the right at any time to seek
injunctive relief or a temporary restraining order or the like from any court of competent jurisdiction at any time as it may deem prudent to protect its Confidential Information and intellectual property rights. 

 

	 	12.8	 Waiver. No waiver of any rights shall be effective unless consented to in writing by the Party to
be charged and the waiver of any breach or default shall not constitute a waiver of any other right hereunder or any subsequent breach or default. 

  

			
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	CONFIDENTIAL	  	Page 43 of 48

	 	12.9	 Independent Contractors. Catalent and Client each acknowledge that they shall be independent contractors
and that the relationship between the two Parties shall not constitute a partnership, joint venture, agency or any type of fiduciary relationship. Neither Catalent nor Client 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 consent of the other Party to do so. 

  

	 	12.10	 Affiliate(s). Any licenses granted under this Agreement by a Party will be deemed to be granted both to
the other Party and the other Party’s Affiliate(s). Catalent shall cause its Affiliate(s) involved in the provision of the Services to comply fully with the provisions of this Agreement to the extent such provisions specifically relate to, or
are intended to specifically relate to, its Affiliate(s), as though such Affiliate(s) were expressly named as joint obligors hereunder. Each Party will be responsible for all acts and omissions of its Affiliates as if they were such Party hereunder.

  

	 	12.11	 Counterparts/Facsimile. This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures and signatures exchanged electronically or by .pdf shall have the same force and effect as original signatures.

  

	 	12.12	 Subcontracting. Catalent shall not subcontract any of its obligations hereunder except with
Client’s prior written consent. Catalent will ensure that each such subcontractor agrees to be bound by obligations similar to those contained herein, including without limitation the obligations set forth in Sections 8 and 9. Catalent will be
responsible for all acts and omissions of its subcontractors as if they were Catalent hereunder. 

  

	 	12.13	 Force Majeure. Neither Party shall be liable for failure to perform its obligations under this Agreement
(or for a delay in the performance of such obligations), and neither shall be deemed in breach of its obligations, if such failure or delay is due to Force Majeure. In event of Force Majeure, the Party affected thereby shall promptly notify the
other Party and use [***] to cure or overcome the same and resume performance of its obligations hereunder. If an event of Force Majeure continues and causes a Party to delay its performance of its obligations for more than [***] days, then the
other Party shall have the right upon written notice to terminate this Agreement without any liability to the other Party (including for any Firm Orders cancelled in connection with such termination). 

  

			
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	CONFIDENTIAL	  	Page 44 of 48

	 	12.14	 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by one Party to the
other are, for all purposes of Section 365(n) of Title XI of the United States Code (“Title XI”), licenses of rights to “intellectual property” as defined in Title XI. If a Party seeks or involuntarily is placed under
Title XI and the trustee rejects this Agreement as contemplated under 11 U.S.C. 365(n)(1), the other Party hereby elects, pursuant to Section 365(n) of Title XI, to retain all rights granted to it under this Agreement to the extent permitted by
Applicable Law. 

  

	 	12.15	 Exporter of Record. Client shall be the exporter of record for any Product shipped out of the United
States. Client warrants that all shipments of Product exported from the United States will be made in compliance with all export laws and regulations and all applicable import laws and regulations of the country of importation. Client shall be
responsible for obtaining any licenses or government authorization(s) necessary for exportation from the United States, and for ensuring that all domestic and international shipments are made in accordance with all Applicable Laws and regulations,
including but not limited to Department of Transportation and Department of Homeland Security regulations related to transportation of biological agents. Client’s designated carrier and freight forwarder shall solely be Client’s agent.
Client shall select and pay the freight forwarder and such designated freight forwarder shall solely be responsible for preparing and filing any relevant declarations or other documents required for the export. Client shall bear all costs and
expenses associated with this Section 12.15 (“Exporter of Record”). 

  

	 	12.16	 Importer of Record. In the event any material or equipment to be supplied by Client, including without
limitation Client-Supplied Components and Bulk Drug Substance, is imported into the United States for delivery to Catalent (“Imported Goods”), such Imported Goods shall be imported DDP Bloomington, IN (Incoterms 2010). Client
shall be deemed to be the “Importer of Record” of such Imported Goods. As the Importer of Record, Client shall be responsible for all aspects of the Imported Goods including, without limitation (a) payment of all tariffs, duties,
customs, fees, expenses and charges payable in connection with the importation and delivery of the Imported Goods, and (b) keeping all records, documents, correspondence and tracking information required by Applicable Laws, rules and
regulations arising out of or in connection with the importation or delivery of the Imported Goods. 

  

	 	12.17	 Quality Agreement. The safety, quality control, and quality assurance aspects of the Services shall be
pursuant to the Quality Agreement. In the event of a conflict between the provisions of this Agreement and the provisions of the Quality Agreement, the provisions of this Agreement shall govern; provided that in the event of a conflict between this
Agreement and the Quality Agreement with respect to quality-related activities, including compliance with CGMP and all other regulatory obligations as they pertain to the Product, the provisions of the Quality Agreement shall govern. The Quality
Agreement is subject to the terms of this Agreement and, accordingly, any material breach of the Quality Agreement shall be deemed to be a material breach of this Agreement. 

  

			
		  	
	CONFIDENTIAL	  	Page 45 of 48

	 	12.18	 Construction; Captions. Each Party acknowledges that it participated in the negotiation and preparation
of this Agreement and that it had the opportunity to consult with an attorney of its choice in connection therewith. Ambiguities, if any, in this Agreement shall not be construed against either Party, irrespective of which Party may be deemed to
have drafted the Agreement or authorized the ambiguous provision. Capitalized terms defined in the singular shall include the plural and vice versa. The terms “includes” and “including” mean “includes, without
limitation,” and “including, without limitation,” respectively. “Shall” and “will” are synonyms. “Or” is used in the inclusive sense (“and/or”) unless the context clearly requires otherwise.
Titles, headings and other captions are for convenience only and shall not affect the meaning or interpretation of this Agreement. 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be signed by their duly authorized representatives to be effective as of the Effective
Date. 
  

									
	Catalent Indiana, LLC	 		 	Horizon Pharma Ireland Limited
					
	By:	 	 /s/ Authorized Signatory
	 	                        	 	By:	 	 /s/ Alan Mac Neice

	[***]	 		 		 	Name:	 	Alan Mac Neice
		 		 		 	Title:	 	Director

  

			
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	CONFIDENTIAL	  	Page 46 of 48

 APPENDIX A 

(Products) 
  

	 	1)	 Teprotumumab 

  

			
		  	
	CONFIDENTIAL	  	Page 47 of 48

 Exhibit A 

Commercial Product Plan 
 [***]

  

			
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	CONFIDENTIAL	  	Page 48 of 48EX-10.5

 Exhibit 10.5 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE HORIZON THERAPEUTICS PLC HAS
DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO HORIZON THERAPEUTICS PLC IF PUBLICLY DISCLOSED. 

EXECUTION VERSION 

License Agreement 
 by and among

 F. Hoffmann-La Roche Ltd, 

a Swiss corporation; 
 Hoffmann-La Roche Inc. 
 a New Jersey corporation 

and 
 River Vision LLC, a Delaware
limited liability company 

 LICENSE AGREEMENT 

 

							
	 1.
	 	DEFINITIONS	  	 	1	 
	 2.
	 	RIVER VISION LICENSES	  	 	9	 
	 3.
	 	ROCHE’S RIGHT OF FIRST OFFER	  	 	12	 
	 4.
	 	DILIGENCE AND REPORTING	  	 	13	 
	 5.
	 	DEVELOPMENT	  	 	13	 
	 6.
	 	SUPPLY	  	 	14	 
	 7.
	 	REGULATORY	  	 	14	 
	 8.
	 	COMMERCIALIZATION	  	 	15	 
	 9.
	 	RIVER VISION PAYMENT OBLIGATIONS	  	 	15	 
	 10.
	 	GENERAL PAYMENT PROVISIONS	  	 	19	 
	 11.
	 	INTELLECTUAL PROPERTY	  	 	21	 
	 12.
	 	TRADEMARKS AND LABELING	  	 	25	 
	 13.
	 	REPRESENTATIONS AND WARRANTIES	  	 	25	 
	 14.
	 	CONFIDENTIALITY; PUBLICATION	  	 	26	 
	 15.
	 	TERM	  	 	27	 
	 16.
	 	INDEMNIFICATION	  	 	32	 
	 17.
	 	DISPUTE RESOLUTION, GOVERNING LAW AND JURISDICTION	  	 	33	 
	 18.    
	 	GENERAL PROVISIONS	  	 	34	 

 LICENSE AGREEMENT 

License Agreement 
 THIS
LICENSE AGREEMENT (“Agreement”) is entered into as of the Effective Date by and among: 

F. HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. (“Roche
Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 
 and 

RIVER VISION LLC, a limited liability company organized and existing under the laws of Delaware, with its principal
office at One Rockefeller Plaza, New York NY, 10020, U.S.A. (“River Vision”). 
 Recitals 

WHEREAS, Roche has conducted certain research and development related to, and possesses certain
intellectual property rights with respect to teprotumumab, an antibody to IGF-1R (“Compound” as further defined below) ; and 

WHEREAS, River Vision desires to obtain, and Roche is willing to grant to River Vision, an exclusive,
royalty-bearing license, with the right to sublicense, under the Roche Patents and Roche Know-How (as defined below), to develop, have developed, commercialize, have commercialized, make, have made, use, have
used, sell, have sold, offer for sale, have offered for sale, import and have imported Compound and/or Product, as appropriate, in the Field in the Territory, subject to the terms and conditions hereof; and 

WHEREAS, Roche desires to obtain, and River Vision is willing to grant to Roche, certain rights with
respect to Compound and Product, subject to the terms and conditions hereof. 
 Agreement 

NOW, THEREFORE, in consideration of the foregoing premises and mutual promises, terms,
conditions, and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows: 

1. DEFINITIONS 

1.1 “Affiliate” shall mean, with respect to either party: (i) an entity which owns,
directly or indirectly, a controlling interest in such party; (ii) an entity in which such party owns, either directly or indirectly, a controlling interest; or (iii) an entity, in which a controlling ownership, directly or indirectly, is
common to the controlling ownership in such party, whereby “controlling interest” shall mean more than 50% (or if the jurisdiction where such entity is domiciled prohibits majority foreign ownership of such entity, the maximum foreign
ownership interest permitted under such laws, provided that such ownership actually allows control of such entity) of the securities or other ownership interest representing the equity with the rights to vote in the designation of the governing
bodies of such entity, or any other agreement or arrangement allowing the factual or legal control 

  
 1 

 LICENSE AGREEMENT 

 

 
of the decisions of such entity or its governing bodies. Anything to the contrary in this paragraph notwithstanding (i) Chugai Pharmaceutical Co., Ltd,
1-9, Kyobashi 2-chome, Chuo-ku, Tokyo, 104-8301, Japan (“Chugai”)
shall not be deemed an Affiliate of Roche unless Roche notifies River Vision that Roche wishes for Chugai to be deemed an Affiliate of Roche, and (ii) any entities that are Affiliated with River Vision as a result of NRM’s Affiliation with
River Vision, shall not be deemed an Affiliate of River Vision unless River Vision notifies Roche that River Vision wishes for any such entity to be deemed an Affiliate of River Vision. 

1.2 “Alliance Manager” shall have the meaning provided in Section 2.7. 

1.3 “Agreement” shall mean this agreement. 

1.4 “Appendix” shall mean an appendix to this Agreement. 

1.5 “Approval” shall mean the first approval, license, registration, or authorization of any
country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a Product in such jurisdiction. 

1.6 “BLA” shall mean a Biologics License Application, or similar application for marketing
approval of the Product in the Field submitted to the FDA, or a foreign equivalent of the FDA. 
 1.7 “BLA
Filing” shall mean the date on which the first BLA for Product in any country of the Territory has been submitted which BLA has been accepted (but not yet approved) by the applicable Regulatory Authority. 

1.8 “Business Day” shall mean 9.00am to 5.00pm local time on a day other than a Saturday, Sunday
or bank or other public or federal holiday in Switzerland or USA. 
 1.9 “Cabilly License
Agreement” shall mean the agreement entered into between River Vision and Roche on or before the Effective Date, as amended now or in the future. 

1.10 “Calendar Year” shall mean the period of time beginning on January 1 and ending
December 31, except for the first year which shall begin on the Effective Date and end on December 31. 
 1.11
“Calendar Quarter” shall mean the four quarters of a Calendar Year, each Calendar Quarter starting on January 1, April 1, July 1 and October 1. 

1.12 “Change of Control” shall have the meaning provided in Section 18.5. 

1.13 “Chugai Agreement” shall mean the License Agreement relating to the Compound between Chugai
and F. Hoffmann-La Roche Ltd dated March 7, 2008 for the territory of Japan, as amended now or in the future. 

1.14 “Combination Product” shall mean any product that contains, in addition to a Compound, one
or more other pharmaceutically active ingredients. 

  
  

2 

 LICENSE AGREEMENT 

 

 1.15 “Commercially Reasonable Efforts” shall
mean (i) with respect to River Vision’s obligation under this Agreement to develop or commercialize Product, the level of efforts required to carry out such obligation in a sustained manner consistent with the efforts a similarly situated
biopharmaceutical company or pharmaceutical company, as the case may be, devotes to its products of similar market potential, profit potential or strategic value, based on conditions then prevailing and (ii) with respect to Roche, the level of
efforts required to carry out a particular obligation under this Agreement in a sustained manner consistent with the efforts a similarly situated biopharmaceutical company or pharmaceutical company, as the case may be, devotes to its products of
similar market potential, profit potential or strategic value, based on conditions then prevailing. 
 1.16
“Compound” shall mean Roche’s proprietary compound teprotumumab, as specified in Appendix 1 

1.17 “Confidential Information” shall mean any and all information, data or know-how (including but not limited to Know-How), whether technical or non-technical, oral or written (and if disclosed orally,
memorialized in writing within [***] days of such oral disclosure), that is disclosed by one party or its Affiliates (“Disclosing Party”) to the other party or its Affiliates (“Receiving Party”).
Information shall not include any information, data or know-how which: 
 (i) was generally available
to the public at the time of disclosure, or information which becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party, 

(ii) can be shown by cogent written records to have been already known to the Receiving Party prior to its receipt from the Disclosing Party,

 (iii) is obtained at any time lawfully from a Third Party under circumstances permitting its use or disclosure, 

(iv) is developed independently by the Receiving Party as evidenced by written records other than through knowledge of Confidential
Information, 
 (v) is required to be disclosed by the Receiving Party to comply with a court or administrative order providing the Receiving
Party furnishes prompt notice (in no event less than [***] days) to the Disclosing Party to enable it to resist such disclosure, or 
 (vi)
is approved in writing by the Disclosing Party for release by the Receiving Party. 
 The terms of this Agreement shall be considered
Confidential Information of both parties. 
 1.18 “Control” or
“Controlled” shall mean, with respect to Compound, Product or any Know-How, Patents, Confidential Information or other intellectual property rights, possession by a party of the ability
(whether by ownership, license or otherwise) to grant access to, to grant use of, or to grant a license or a sublicense to Compound or Product under such Know-How, Patents or intellectual property rights
without violating the terms of any agreement or other arrangement with any Third Party. 

  
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 1.19 “Data Room” shall mean the due diligence
data room containing all data and information Controlled by River Vision as of the applicable Review Period pertaining to Compound and/or Product, including but not limited to pre-clinical and clinical data,
River Vision Patents, regulatory correspondence, CMC data related to the program River Vision generated since the Effective Date. 

1.20 “Drug Product” shall mean Compound that has undergone all processing stages up to and
including lyophilization but not including the labeling and secondary packaging. 
 1.21 “Effective
Date” shall mean June 15, 2011. 
 1.22 “EU” shall mean the European
Community and all its present and future member countries. 
 1.23 “FDA” shall mean the US
Federal Food and Drug Administration and any successor agency thereof. 
 1.24 “FDCA” shall
mean the Food, Drug and Cosmetics Act of the US. 
 1.25 “Field” shall mean treatment or
prevention of human diseases and conditions, except Oncology. 
 1.26 “First Commercial Sale”
shall mean the first sale of a Product by River Vision or its Affiliates to a Third Party for end use or consumption of such Product in a country after the Regulatory Authority of such country has granted Regulatory Approval or, if no such
Regulatory Approval or similar marketing approval is required, the date upon which such Product first commercially launched in such country. Sale to an Affiliate shall not constitute a First Commercial Sale. 

1.27 “[***] Agreement” shall mean the agreement between [***] and Roche dated
June 6, 2002, as amended now or in the future. 
 1.28 “[***]
Agreement” shall mean the agreement between [***] and Roche dated November 1, 2003, as amended now or in the future. 

1.29 “ICD-Classification” shall mean the then current
International Classifications of Diseases and Related Health Problems of the World Health Organization (WHO). 
 1.30
“Indication” shall mean those indications defined within a block (e.g. block H36 “Retinal disorders in diseases classified elsewhere”) of the ICD Classification. 

1.31 “Initiation” of a clinical trial shall mean the first administration of a Product to a
patient in a clinical trial related to Compound or Product. 

  
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 1.32 “Insolvency Event” shall mean
circumstances under which a party: 
 a) has a receiver, bankruptcy trustee or similar officer appointed over all or a material part of its
assets or undertaking; 
 b) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any
jurisdiction); or 
 c) is subject to voluntary or involuntary bankruptcy or judicial restructuring proceedings. 

1.33 “Invention” shall mean an invention that is conceived or reduced to practice in connection
with any activity carried out pursuant to this Agreement. Under this definition, an Invention may be made by employees, agents or consultants of River Vision solely or jointly with a Third Party (a “River Vision Invention”),
by employees, agents or consultants of the Roche Group solely or jointly with a Third Party (a “Roche Invention”), or jointly by employees, agents or consultants of River Vision and a member of the Roche Group with or without
a Third Party (a “Joint Invention”). 
 1.34 “Joint Intellectual
Property” shall mean the Joint Patents and Joint Know-How. 
 1.35
“Joint Know-How” means Know-How that is developed by one or more employees, agents or consultants of River Vision or any of its Affiliates,
on the one hand, and one or more employees, agents or consultants of Roche or any of its Affiliates, on the other hand, under this Agreement. 

1.36 “Joint Patents” or “Joint Patent Rights” shall mean Patent Rights
that claim Joint Know-How. 
 1.37
“Know-How” shall mean data, knowledge and information, and materials, including but not limited to all tangible and intangible techniques, technology, practices, trade secrets,
inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, analytical and quality control data, results, descriptions and compositions of matter, chemical manufacturing data, data
and results from toxicological, pharmacological, preclinical and clinical testing and studies, assays, platforms, materials, samples, formulations, specifications, quality control testing data, that are necessary or useful for the discovery,
manufacture, development or commercialization of Compound or Product. 
 1.38
“[***] Agreement” shall be the agreement between [***] (along with any successors and assigns, “[***]”) and Roche relating to NMB1 dated December 7,
2009, as amended now or in the future. 
 1.39 “Net Sales” shall mean, with respect to River
Vision the amount of gross sales of a Product in the Territory invoiced by River Vision or its Affiliates or Partners to Third Parties, as reduced by the following deductions to the extent actually allowed or incurred with respect to such sales:
[***] 

  
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 [***]. If Product is sold as part of a Combination Product (as defined below), then the
parties shall meet approximately [***] prior to anticipated First Commercial Sale to negotiate, on a country-by-country basis, in good faith and agree to an appropriate
adjustment to Net Sales, on a country-by-country basis, to reflect the relative significance of the Compound and other pharmaceutically active ingredients contained in
the Combination Product. If the parties cannot reach agreement, then the Net Sales of the Combination Product, for the purposes of determining royalty payments, shall be determined by [***]. 

1.40 “NRM” shall mean Narrow River Management LLC. 

1.41 “Oncology” shall mean any indication defined within Chapter II of the ICD Classification,
or in a chapter that replaces Chapter II in successor versions of the ICD Classification. For the purposes of clarity, in the ICD-10 classification, any block within the range C01 to D48 shall fall within the
definition of Oncology. 
 1.42 “Patent Rights” or “Patents” shall
mean (a) patents, re-examinations, reissues, renewals, extensions, supplementary protection certificates, and term restorations, and (b) pending applications for patents, including, without
limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications, including, without limitation, inventors’
certificates. 
 1.43 “Partner” shall mean an entity with which River Vision will enter or has
entered a Partner Agreement. 
 1.44 “Partner Agreement” shall mean any agreement between
River Vision and a Third Party granting rights to develop and/or commercialise the Compound and/or the Product (including but not limited to a sub-license agreement with a Third Party or an assignment of this
Agreement to a Third Party but not a Change of Control), other than a sub-contract pursuant to Section 2.4. 

1.45 “Pharmacovigilance Agreement” shall mean an agreement entered into by the parties to set
forth the responsibilities and obligations of the parties with respect to the procedures and timeframes for compliance with the applicable laws and regulations pertaining to safety reporting of the Products and related activities. 

  
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 1.46 “Phase 2 Trial” shall mean a human
clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. § 312.21(a), (or its successor regulation), and the foreign equivalent thereof. 

1.47 “Phase 3 Trial” shall mean a human clinical trial that would satisfy the requirements for a
Phase 3 study as defined in 21 CFR § 312.21(c) (or its successor regulation), and the foreign equivalent thereof. 

1.48 “Process Manufacture Transfer” shall mean the actual transfer of the Process Manufacture Know-How listed in Appendix 3, such transfer to occur not earlier than the first anniversary of the Effective Date. 

1.49 “Process Manufacture Know-How” shall mean the part
of the Roche Know-How (described in Appendix 3) that will only be disclosed to River Vision after payment of the Process Manufacture Transfer Payment. 

1.50 “Process Manufacture Transfer Payment” shall have the meaning provided in
Section 9.3(a). 
 1.51 “Product” shall mean any pharmaceutical or therapeutic product
containing the Compound, and includes without limitation Combination Products. If a given Product is commercialized in different formulations or dosage forms, then such formulations and dosage forms shall be considered as one single Product. 

1.52 “Regulatory Approval” shall mean any and all approvals (including price and reimbursement
approvals, if required), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import,
transport and/or sale of a Product in such jurisdiction. 
 1.53 “Regulatory Authority” shall
mean the FDA for the US and any equivalent governmental agency or body competent in a country (or group of countries like the European Union) to grant Regulatory Approval or other authorizations or licenses required for the development,
manufacturing, marketing, reimbursement and/or pricing of pharmaceutical products in such country. 
 1.54
“River Vision Intellectual Property” shall mean the River Vision Patents, River Vision Know-How and River Vision’s interest in the Joint Intellectual Property. 

1.55 “River Vision Know-How” shall mean, to the extent
used for the development, manufacture or commercialization of Compound or Product based thereon, information not included in the River Vision Patents that River Vision, any of its Partners or any of its Affiliates Controls on the Effective Date or
during the Term, provided however that Roche Know-How shall not be deemed River Vision Know-How. 

1.56 “River Vision Patents” shall mean, to the extent used for the development, manufacture or
commercialization of Compound or Product based thereon, all Patents that River Vision, any of its Partners or any of its Affiliates Controls as of the Effective Date or during the Term, provided however that the Roche Patents shall not be deemed
River Vision Patents. 

  
  

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 1.57 “River Vision Studies” shall mean the
studies to be performed by River Vision with Drug Product, as described in Appendix 4. 
 1.58 “Roche
Intellectual Property” shall mean the Roche Patents, the Roche Know-How and Roche’s interest in the Joint Intellectual Property. 

1.59 “Roche Know-How” shall mean the Know-How Controlled by Roche listed in Appendix 3 of this Agreement. The term Roche Know-How shall include Process Manufacture
Know-How. 
 1.60 “Roche Patents” shall mean the
Patents or Patent Rights Controlled by Roche as exhaustively listed in Appendix 2 of this Agreement, along with all Patents and Patent Rights that claim priority to one or more of such Patents or Patent Rights so listed in such Appendix 2. 

1.61 “Royalty Term” shall mean, in the case of any Product in any country of the Territory, the
period of time commencing on the date of First Commercial Sale of such Product in such country and ending upon the later of: 
  

	 	(a)	 the expiration of the
last-to-expire Valid Claim within the Roche Patents and/or Joint Patent Rights covering the composition, use or manufacture of such Product in such country where such
activity occurs, or 

  

	 	(b)	 ten (10) years after the date of First Commercial Sale of such Product in such country.

 1.62 “Section” shall mean a section of this Agreement. 

1.63 “Supported Shelf Age” shall have the meaning provided in Section 6.1(c). 

1.64 “Term” shall have the meaning provided in Section 15.1. 

1.65 “Territory” shall mean all countries and territories of the world, except Japan. 

1.66 “Third Party” shall mean an entity or person other than (a) Roche or its Affiliates
and (b) River Vision or its Affiliates. 
 1.67 “US” or “United
States” means the United States of America and its territories and possessions. 
 1.68 “Valid
Claim” shall mean a claim contained in: 
  

	 	(a)	 an issued and unexpired Roche Patent or Joint Patent Rights which has not been held unenforceable,
unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through
abandonment, reissue, disclaimer or otherwise; or 

  
  

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	 	(b)	 a patent application that is included in the Roche Patents or Joint Patent Rights that has been
prosecuted in good faith and pending for less than [***] years. If a claim or a patent application that ceased to be a Valid Claim under clause (b) of the preceding sentence because of the passage of time later issues as a part of a patent
within clause (a) of the preceding sentence, then it shall again be considered a Valid Claim effective as of the issuance of such patent. 

2. RIVER VISION LICENSES 

2.1 License grants. 

(a) General. Subject to the terms and conditions of this Agreement, Roche hereby grants to River Vision (i) an exclusive (even as
to Roche), royalty-bearing license, under the Roche Intellectual Property to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import and have
imported Compound and/or Product in the Field in the Territory, and (ii) subject to the terms of Section 11, an exclusive license and right to enforce the Roche Patents against anyone making, using, selling, offering for sale or importing
any IGF-1 R antibody (in addition to Compound and Product) in the Field in the Territory, other than for this clause (ii) those IGF-1 R antibodies (but not
including Compound or Product) developed and commercialized by Roche with its Affiliates and licensees. For clarity, River Vision is not granted any license or right to practice the Roche Patents under clause (ii), but rather to enforce the Roche
Patents as provided in such clause (ii). 
 (b) Rights in Japan. If Chugai terminates its agreement with Roche relating to the
Compound to Roche or such agreement otherwise terminates for any reason, then (i) the Territory shall automatically be deemed to include the territory of Japan, (ii) Roche shall automatically license and transfer to River Vision any
Patents, Know-How, Regulatory Approvals, regulatory documentation or filings, and other rights or documentation Controlled by Roche or any of its Affiliates as a result of such termination, and (iii) such
Patents and Know-how (including those within the Territory) shall be deemed Roche Patents and Roche Know-How. Roche hereby grants as of the Effective Date a non-exclusive sub-license to the improvements (as defined in the Chugai Agreement) made by Chugai under the Chugai Agreement to develop, have developed, make, have made, use,
have used, sell, have sold, offer for sale, have offered for sale, import and have imported Compound and/or Product in the Field in the Territory. Such improvements shall be deemed Roche Patents and Roche
Know-How, subject to any third party obligations. 
 (c) Rights in Oncology. If Roche, at its
own discretion, elects to out-license the rights to the Compound in Oncology, then River Vision shall have the exclusive option right to extend the Field to Oncology. Roche will provide written notice to River
Vision of its intent to license its rights with respect to Oncology. River Vision shall have [***] days after receipt of such notice to notify Roche of its intention to exercise its option right. If River Vision elects to exercises its option right,
then the parties shall negotiate and enter into the terms for such extension of the Field in good faith. 

  
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 2.2 Sub-Licenses. 

(a) Under the [***] Agreement. Roche hereby grants an exclusive (even as to Roche) sub-license
of the rights licensed to Roche under the [***] Agreement solely to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import and have imported
Compound and/or Product in the Field in the Territory. The sublicense granted under this Section 2.2 shall be subject to the rights and obligations and undertakings of Roche, as applicable and consistent with the [***] Agreement (a copy of
which is attached hereto as Appendix 5, and incorporated herein by reference). Roche shall act as the sole direct contact with [***] in relation to the sub-license under this Section 2.2. 

(b) Under the [***] Agreement. Roche hereby grants an exclusive (even as to Roche) sub-license
of the rights licensed to Roche under the [***] Agreement solely to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, have imported and import
Compound and/or Product in the Field in the Territory. The sublicense granted under this Section 2.2 shall be subject to the rights and obligations and undertakings of Roche, as applicable and consistent with the [***] Agreement (a copy of
which is attached hereto as Appendix 6, and incorporated herein by reference). Roche shall act as the sole direct contact with [***] in relation to the sublicense under this Section 2.2. 

(c) Under the [***] Agreement. Roche hereby grants an exclusive (even as to Roche) sub-license
of the rights licensed to Roche under the [***] Agreement solely to develop, have developed, commercialize, have commercialized, make, have made, use, have used, sell, have sold, offer for sale, have offered for sale, import and have imported
Compound and/or Product in the Field in the Territory. The sublicense granted under this Section 2.2 shall be subject to the rights and obligations and undertakings of Roche, as applicable and consistent with the [***] Agreement (a copy of
which is attached hereto as Appendix 7, and incorporated herein by reference). Roche shall act as the sole direct contact with [***] in relation to the sublicense under this Section 2.2. 

(d) Compliance with terms. River Vision shall comply with the terms of the [***] Agreement, the [***] License Agreement and the [***]
License Agreement, to the extent such terms are disclosed in the respective Appendices attached hereto. 
 (e) Sub-license agreements. Roche shall not amend the [***] Agreement, the [***] Agreement or the [***] Agreement in a manner that materially affects any such sub-licenses
hereunder, shall perform its obligations under such agreements, shall use Commercially Reasonable Efforts to enforce and maintain such agreements with respect to the Compound and/or the Product, and shall promptly notify River Vision in writing of
any threatened or actual termination or notice regarding same with respect to such agreements with respect to the Compound and/or the Product. Roche shall provide copies of any amendments to such agreements (with reasonable redactions) to River
Vision once executed. If any such agreement terminates or may terminate, Roche shall use Commercially Reasonable Efforts to maintain the applicable sub-license to River Vision; if Roche is not able to maintain
the applicable sub-license, River Vision shall have the right to attempt to cure any breach giving rise to such actual or threatened termination and may credit any amounts paid by River Vision to maintain any
such sub-license against any amounts owed to Roche hereunder, provided that such amounts credited against any amounts owned to Roche hereunder shall not exceed the amount owed by Roche for the respective
license. River Vision shall inform Roche of any intended interactions with [***], [***] or [***], as applicable. 

  
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 2.3 Right to Sublicense to its Affiliates. Subject to Roche’s
rights under Section 3, River Vision shall have the right to grant written sublicenses to its Affiliates under its rights granted under Section 2.1 and Section 2.2. without prior approval of Roche and solely to the extent necessary to
develop, commercialize, make, use, offer for sale, sell or import (and have others do the same) Compound and/or Product in the Field in the Territory. If River Vision grants such a sublicense, River Vision shall ensure that all of the applicable
terms and conditions of this Agreement shall apply to the Affiliate to the same extent as they apply to River Vision for all purposes. River Vision assumes full responsibility for the performance of all obligations and observance of all terms so
imposed on such Affiliate and shall itself account to Roche for all payments due under this Agreement by reason of such sublicense. 

2.4 Sub-Contractors. River Vision has the right to sub-contract the work performed under this Agreement. However, River Vision shall only sub-contract the manufacture of the Compound or Product [***]. Any sub-contract agreement shall include the right to disclose (i) a copy of the Agreement and confidential information to Roche and (ii) the right to assign the agreement to Roche, including the right to
transfer of the ownership of data, information and results arising therefrom to Roche to the same extent as to River Vision. 

2.5 Right to enter into a Partner Agreement with Third Parties. Subject to Roche’s rights under Section 3,
River Vision shall have the right to enter into a Partner Agreement, including but not limited to granting sublicenses to Partners under its rights granted under Section 2.1 and Section 2.2. Any rights granted to a Third Party under this
Agreement shall be solely to the extent necessary to develop, commercialize, make, use, offer for sale, sell or import (and have others do the same) Compound and/or Product in the Field in the Territory. River Vision shall ensure that all of the
applicable terms and conditions of this Agreement, including the obligations under the [***] Agreement, the [***] Agreement and the [***] Agreement, shall apply to the Partner under the Partner Agreement to the same extent as they apply to River
Vision for all purposes. River Vision assumes full responsibility for the performance of all obligations and observance of all terms so imposed to the Partner under such Partner Agreement and shall itself account to Roche for all payments due under
this Agreement. The Partner of River Vision shall have no right to further sub-license rights to develop and commercialise the Compound or Product to a Third Party, with the understanding that co-promotion or distribution or other marketing arrangements are permitted. 
 River Vision shall disclose a copy of the
draft Partner Agreement to Roche, subject to redaction of financial terms. [***]. 
 2.6
Know-How Transfer. 
 (a) Roche Know-How transfer.
Promptly after the Effective Date, Roche will transfer the Roche Know-How listed in Appendix 3 to River Vision, with the exception of the Process Manufacture Know-How.
The Process Manufacture Know-How will be transferred within [***] days after written request from River Vision. 

(b) Technical Support. If River Vision has made the Process Manufacture Transfer Payment, then Roche will provide up to [***] man days
of technical support free of charge in order to assist River Vision with the Process Manufacture Transfer to a CMO agreed between Roche and River Vision. This support shall be used in the [***] month period that starts with the receipt by Roche of
the Process Manufacture Transfer Payment. Further technical support from Roche will be provided at Roche’s discretion and, if such support is provided by Roche, charged at Roche’s standard commercial rate applicable at that time. 

  
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 (c) Follow-up Questions. Roche shall provide
up to [***] hours for general questions and [***] hours for regulatory questions free of charge. 
 (d) No further obligation. Roche
shall have no obligation to transfer any Know-How or to provide technical support other than expressly stated in this Section 2.6. 

2.7 Alliance Manager. To facilitate communication between the parties, each party shall designate an Alliance Manager
within thirty (30) days after the Effective Date. The Roche Alliance Manager and his/her counterpart at River Vision shall be the primary points of contact between the parties with respect to all matters arising under this Agreement. Each party
may change its Alliance Manager from time to time in its sole discretion, effective upon notice to the other party of such change. 

2.8 Freedom-to-Operate. River Vision
hereby grants to Roche a non-exclusive, perpetual, worldwide, royalty-free license, with the right to sublicense, under the River Vision Patents, to operate, utilize or improve those IGF-1 R antibodies (but not including Compound or Product) developed and commercialized by Roche with its Affiliates and licensees, but only in Oncology. 

2.9 Retained Rights. Roche shall retain the right for Roche and its Affiliates and licensees to use the Compound for
internal pre-clinical purposes in and outside of the Field; provided that no studies requiring reporting to Regulatory Authorities in the Territory will be conducted in the Field. Except as permitted by this
Agreement or any other agreement between the parties, Roche and its Affiliates and licensees will not use the Compound or Product for any other purpose, nor will Roche or any of its Affiliates or licensees practice any of the Patents or Know-How (including, without limitation, any Roche Intellectual Property) exclusively licensed or sub-licensed to River Vision hereunder within the scope of those licenses in
the Field in the Territory. 
 3. ROCHE’S RIGHT OF FIRST
OFFER. 
 3.1 Notice to Roche by River Vision. If River Vision, at any time during the Term but not
earlier than availability of the data generated under the first of the River Vision Studies to be completed, intends to (i) enter into a Partner Agreement relating to the Compound and/or the Product or (ii) undergo a Change of Control or
(iii) enter into Phase 3 Trial with the Compound without a Partner, then River Vision shall have the obligation to inform Roche in writing accordingly and give Roche access to the Data Room. 

3.2 Process. Within [***] days following the receipt by Roche of such written notice, Roche shall review the Data Room
(“Review Period”). If Roche is interested in taking the project back, then the parties shall have [***] days from the date of the expiry of the Review Period to exclusively negotiate the terms to regain the rights to the
Compound and/or the Product (i.e. to take the license for the whole program back and ownership under the River Vision Patents and Know-How or, if transfer of ownership is not possible, a perpetual, exclusive
license for the whole program) (the “Negotiation Period”). If (i) the parties, after good faith discussions in the Negotiation Period, cannot agree on the structure and terms of such agreement or (ii) Roche confirms

  
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 in writing to River Vision that it is not interested in regaining the rights to the Compound
and/or the Product, then River Vision shall be free to enter into a Partner Agreement with a Third Party or to undergo a Change of Control and this Section 3 will have no further force or effect, subject to the limitations specified in Sections
2.5 and 18.4 with respect thereto. Notwithstanding the foregoing, if River Vision (1) does not enter into a Partner Agreement or does not undergo a Change of Control but continues the development and/or commercialisation of the Compound and/or
Product and (2) at any time during the Term thereafter there is additional material clinical data available as compared to the clinical data previously reviewed by Roche in the Data Room, and (3) River Vision thereafter intends to enter
into a Partner Agreement relating to the Compound and/or the Product or undergo a Change of Control, then Roche’s Right of First Offer under this Section 3 shall apply one more time again. If (a) Roche does not regain its rights to
the Compound and/or the Product if offered to Roche a second time under this Section 3.2 and (b) River Vision thereafter intends to enter into a Partner Agreement or to undergo a Change of Control, then Roche shall have a non-exclusive right under this Section 3.2 to negotiate the terms to regain the rights to the Compound and/or the Product. 

4. DILIGENCE AND REPORTING 

4.1 Diligence. River Vision shall use Commercially Reasonable Efforts to develop and commercialize the Compound and/or
Product in the Field in the Territory. 
 4.2 Reporting. 

(a) Prior to First Commercial Sale. During the Term up to First Commercial Sale of the Product, River Vision shall have the obligation
to submit detailed annual reports to Roche summarizing development progress of the Product, including the Development Plan, pursuant to Section 5.1. The first such annual report shall be provided on the first anniversary of the Effective Date.
Each subsequent annual report shall be provided on subsequent anniversaries of the Effective Date. 
 (b) After First Commercial Sale.
From the First Commercial Sale of the Product during the Term, River Vision shall inform Roche in a detailed report regarding the commercialization of Products in the Field in the Territory by River Vision, its Affiliates and Partners. The first
such annual report shall be provided on the first anniversary of the First Commercial Sale. Each subsequent annual report shall be provided on subsequent anniversaries of the First Commercial Sale. 

5. DEVELOPMENT 

5.1 Responsibility. River Vision, at its sole cost, shall use Commercially Reasonable Efforts to conduct the development
of Compound and/or Product in the Field in the Territory. 
 5.2 Development Plan. River Vision will conduct (or have
conducted) the development of the Compound and Product in the Field in the Territory in accordance with a written plan (“Development Plan”). River Vision shall send a then current version of the Development Plan to Roche at
each anniversary of the Effective Date. If River Vision wishes to improve the manufacturing process of the Compound or the Product resulting in a change of the cell bank expressing the Compound, then River Vision shall provide written notice to
Roche of the nature of such intended work [***]. 

  
  

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 5.3 Different Product. If, as a result of any permitted work performed
pursuant to Section 5.2, River Vision uses a new master cell line to develop and subsequently commercializes a Compound and/or a Product as a new biological entity (in addition to a first Compound and/or Product), so that such Compound and/or
Product qualifies for an independent period of data exclusivity based on it being a new biological entity under a separate regulatory process, then such Compound and/or Product shall be a separate Product for purposes of Section 9. 

6. SUPPLY 

6.1 Clinical Supply of Product. 

(a) Responsibility. River Vision shall be solely and exclusively responsible at its own expense for the manufacture and supply of
clinical supplies of the Product. River Vision shall supply at its own cost all clinical supply of Product during the Term, either by itself, or through a Third Party. 

(b) Supply. Notwithstanding Section 6.1(a), Roche shall supply to River Vision Drug Product as specified in Appendix 4 purely for
the purposes of conducting the River Vision Studies. Roche shall have no obligation to produce, process or test such Drug Product, except as explicitly stated in this Section 6 or on Appendix 4. The parties shall enter into a Quality Agreement
within ninety (90) days of the Effective Date. 
 (c) Restrictions of Use. River Vision shall not administer to any patient Drug
Product supplied by Roche that has an actual shelf age higher than the shelf age supported by the last real-time stability data within specification (“Supported Shelf Age”). In this context actual shelf age means the period
of time between present date and the manufacturing date of the respective batch. Supported Shelf Age is stated in Appendix 4 and will be revised and communicated to River Vision in written form with each future stability report, and will become
integral part of Appendix 4 together with the supportive stability report. 
 6.2 Commercial Supply of Product. River
Vision shall be solely and exclusively responsible at its own expense for the commercial manufacture and commercial supply of Product for sale in the Territory, either by itself or through Third Parties. 

7. REGULATORY 

7.1 Responsibility. River Vision, at its sole cost, shall pursue all regulatory affairs related to Product in the Field
in the Territory including the preparation and filing of applications for Regulatory Approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, import, have imported sell and have
sold Compound and/or Product. River Vision shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for Compound and Product in all countries in the Territory.
River Vision shall own and file in their discretion all regulatory filings and Regulatory Approvals for the Compound and Product in all countries of the Territory. River Vision shall supply Roche with a copy of all material communications related to
Compound and Product to or from the regulatory agencies. 

  
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 7.2 IND. River Vision shall establish a separate IND or equivalent
under which to conduct their clinical trials of the Compound and Product in the Field in the Territory. River Vision shall submit draft protocols to Roche for review and approval as long as patients are still being treated in Roche trials sponsored
or supported by Roche. River Vision and its Affiliates and Partners shall have the right to cross-reference any IND or other regulatory documentation of Roche or any of its Affiliates regarding Compound or Product. 

7.3 Informed Consent forms. Any Informed Consent forms with patients under any River Vision study shall include the
right to transfer samples, data and information to Roche. 
 7.4 Pharmacovigi lance Agreement. The parties agree that
they shall execute a separate Pharmacovigi lance Agreement if deemed applicable prior to, but no later than, the date on which River Vision establishes either a separate IND or equivalent under which they intend to initiate their first clinical
trial of the Compound or Product in the Field in the Territory. 
 8. COMMERCIALIZATION 

River Vision, at its own expense, shall have sole responsibility and decision making authority for the marketing, commercialization, promotion, sale and
distribution of Products in the Field in the Territory. 
 9. RIVER VISION PAYMENT
OBLIGATIONS 
 9.1 License Fee. River Vision shall pay to Roche a one time, non-refundable, non-creditable payment of [***] CHF ([***] CHF) within [***] days after the Effective Date. Any non-royalty payments
payable to Genentech under the Cabilly License Agreement shall be creditable in full against amounts payable to Roche hereunder. 

9.2 Execution of a Partner Agreement. River Vision shall pay to Roche a one time,
non-refundable, non-creditable payment in the amount of CHF [***] ([***] CHF) within [***] days after the execution of a Partner Agreement or a Change of Control. 

9.3 Process Manufacture Transfer and Other Payments. 

(a) River Vision shall make a one time, non-refundable,
non-creditable payment in the amount of CHF [***] ([***] CHF) within [***] days after the date of the initiation of the Process Manufacture Know-How transfer (the
“Process Manufacture Transfer Payment”). 
 (b) River Vision shall make a one time, non-refundable, non-creditable payment in the amount of [***] ([***] CHF) within [***] days after the date on which [***]. 

  
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 (c) If the payments under Sections 9.3(a) and (b) have not been made when River
Vision enters into a Partner Agreement or undergoes a Change of Control, as applicable, such payments shall be due within [***] days after the effective date of the Partner Agreement or the Change of Control, as applicable. 

9.4 Development Event Payments 

(a) For the first Indication. 
 River
Vision shall pay up to a total of CHF [***] (CHF [***]) in relation to the achievements of events with respect to each Product for the first Indication developed for the applicable Product. The development event payments under this
Section 9.4(a) shall be paid for the first Indication on a Product-by-Product basis as follows: 

 

			
	Development Event	  	Event Payment in [***] CHF
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	 Total
	  	[***]

 Each of the foregoing payments shall be paid no more than once for each Product. 

(b) For the second and each subsequent Indication 

River Vision shall pay up to a total of CHF [***] (CHF [***]) per Indication in relation to the achievements of events with respect to each Product for the
second and each subsequent Indication developed for the applicable Product. The development event payments under this Section 9.4(b) shall be paid for the second and each subsequent Indication on a Product-by-Product basis as follows: 
  

			
	Development Event	  	Event Payment in [***] CHF
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	[***]	  	[***]
	 Total
	  	[***]

  
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 (c) Development Event Payments for the territory of Japan 

In addition to payments due under paragraph (a) and (b) above, River Vision shall pay up to a total of CHF [***] (CHF [***]) in relation to the
achievements of events with respect to each Product for the first Indication developed for the applicable Product. The development event payments under this Section 9.4(c) shall be paid for the first Indication on a Product-by-Product basis as follows: 
  

			
	Development Event	  	Event Payment in [***] CHF
	[***]	  	[***]
	[***]	  	[***]
	 Total
	  	[***]

 Each of the foregoing payments shall be paid no more than once for each Product. 

In addition to payments due under paragraphs (a) and (b) above, River Vision shall pay up to a total of CHF [***] (CHF [***]) per Indication in relation
to the achievements of events with respect to each Product for the second and each subsequent Indication developed for the applicable Product. The development event payments under this Section 9.4(c) shall be paid for the second and each
subsequent Indication on a Product-by-Product basis as follows: 
  

			
	Development Event	  	Event Payment in [***] CHF
	[***]	  	[***]
	[***]	  	[***]
	 Total
	  	[***]

 If Chugai terminates the Chugai Agreement [***], and Japan is within the Territory under this Agreement, then all applicable
payments under this Section 9.4(c) shall be due. 
 (d) Development Event Payments for the second Product and each subsequent Product

 For the second Product and each subsequent Product, the development event payments payable to Roche under Sections 9.4(a), 9.4(b) and 9.4(c) shall be
reduced by [***]%. 

  
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 9.5 Sales Based Events 

River Vision shall pay to Roche up to a total of CHF [***] (CHF [***]) based on aggregate Calendar Year Net Sales of a Product in the
Territory: 
  

			
	Net Sales Threshold	 	Payment [***] CHF
	Total Calendar Year Net Sales in the Territory of a Product exceed CHF [***] CHF	 	[***]
	Total Calendar Year Net Sales in the Territory of a Product exceed CHF [***] CHF	 	[***]
	Total Calendar Year Net Sales in the Territory of a Product exceed CHF [***] CHF	 	[***]
	 TOTAL
	 	[***]

 Each of the sales based event payments shall be paid no more than once, at first occurrence of the event for the Product in
the Territory first reaching the respective Net Sales Threshold, irrespective of whether or not the previous sales based event payment was triggered by the same or by a different Product, and shall be
non-refundable and non-creditable. 
 9.6
Royalties. 
 Royalties shall be payable by River Vision on Net Sales of Products on a
Product-by-Product and country-by-country basis until the expiry of the Royalty Term.
Thereafter, the licenses set forth in Section 2 shall be fully paid up and royalty-free for a Product in a country. 
 The following royalty rates
shall apply to the respective tiers of aggregate Calendar Year Net Sales of a Product in the Territory, on an incremental basis, as follows: 
  

			
	 Tier of Calendar Year

Net Sales in million CHF
	 	Percent (%) of Net Sales
	 [***]
	 	9
	 [***]
	 	[***]
	 [***]
	 	12

 For example, if Net Sales of a Product in the Territory, for a given Calendar Year, are CHF [***], then the royalty rate
applicable on such Net Sales of such Product for that year shall be calculated as follows: 
 [***]. 

9.7 Credit of Royalty Payments 

River Vision may credit [***] of the royalties payable to Genentech under the Cabilly License Agreement against the royalties payable to Roche under
Section 9.6. 
 9.8 Third Party Payments 

Roche shall be responsible at its sole expense for making any payments under the [***] Agreement, the [***] Agreement and the [***] Agreement. 

  
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 River Vision shall be responsible for and pay or have paid any consideration owed to any Third Party in
relation to Third Party intellectual property rights, except with respect to any payments owed under the [***] Agreement, the [***] Agreement and the [***] Agreement in accordance with the terms of such agreements. Such Third Party payments shall
not be deductable against the amounts payable under this Agreement or refundable under this Agreement. [***]. 
 10. GENERAL
PAYMENT PROVISIONS 
 10.1 Accounting and reporting 

(a) Timing of Payments. 

(i) All payments made under Section 9.4 shall be non-refundable and non-creditable. River Vision shall inform Roche by written notice within [***] days after the occurrence of the respective event and the respective payment shall be made within [***] days after the occurrence of the
respective event. 
 (ii) River Vision shall calculate royalties on Net Sales quarterly as of March 31, June 30, September 30
and December 31 (each being the last day of an “Accounting Period”) and shall pay royalties on Net Sales within the [***] days after the end of each Accounting Period in which such Net Sales occur. 

(b) Late Payment. Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to
the extent permitted by applicable law, at [***] percentage points above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days
such payment is overdue. 
 (c) Currency of Payment. Royalties on Net Sales shall be paid by River Vision in Swiss Francs. 

(d) Currency Conversion. When calculating the Sales for countries other than Switzerland, River Vision shall convert the amount of such
sales in currencies other than Swiss Francs into Swiss Francs using for internal foreign currency translation River Vision’s then current standard practices actually used on a consistent basis in preparing its audited financial statements. 

10.2 Reporting. With each payment River Vision shall provide Roche in writing for the relevant Calendar Quarter on a Product-by-Product basis the following information: 
 a) Gross
Sales on a country-by-country basis in local currencies; 

b) Net Sales on a country-by-country basis in local currencies;

 c) Net Sales on a country-by-country basis in Swiss
Francs; 
 d) Total Net Sales in the Territory in Swiss Francs; 

e) Total royalty payable in Swiss Francs; and 

f) Exchange rates used for the conversion to Swiss Francs made under Section 10.1(d) and Section 10.2(c). 

  
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 10.3 Taxes 

Roche shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to Roche under this
Agreement. 
 If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any
royalty or other amounts payable under this Agreement to Roche, then River Vision shall promptly pay such tax, levy or charge for and on behalf of Roche to the proper governmental authority, and shall promptly furnish Roche with receipt of payment.
River Vision shall be entitled to deduct any such tax, levy or charge actually paid from royalty or other payment due to Roche or be promptly reimbursed by Roche if no further payments are due to Roche. Each party agrees to reasonably assist the
other party in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted. 

10.4 Auditing 

(a) Roche’s Right to Audit 

River Vision shall keep, and shall require its Affiliates and Partners to keep, full, true and accurate books of account containing all particulars that may be
necessary for the purpose of calculating all royalties payable under this Agreement. Such books of accounts shall be kept at their principal place of business. At the expense of Roche, Roche has the right to engage Roche’s then current
worldwide independent public accountant to perform, on behalf of Roche an audit of such books and records of River Vision and its Affiliates and Partners, that are deemed necessary by the public accountant to report on Net Sales of Product for the
period or periods requested by Roche and the correctness of any report or payments made under this Agreement. 
 Upon timely request and at least [***]
working days’ prior written notice from Roche, such audit shall be conducted in the countries specifically requested by Roche, during regular business hours in such a manner as to not unnecessarily interfere with River Vision’s normal
business activities, and shall be limited to results in the [***] calendar years prior to audit notification. 
 Such audit shall not be performed more
frequently than once per Calendar Year nor more frequently than once with respect to records covering any specific period of time. 
 All information, data
documents and abstracts herein referred to shall be used only for the purpose of verifying royalty statements, shall be treated as River Vision Confidential Information subject to the obligations of this Agreement and need neither be retained more
than [***] year after completion of an audit hereof, if an audit has been requested; nor more than [***] years from the end of the calendar year to which each shall pertain; nor more than [***] year after the date of termination of this Agreement.

 (b) Sharing of draft reports. The auditors shall share all draft reports with Roche and River Vision before the final document is
issued; the auditors shall not interpret the agreement. The final report shall be shared by Roche and River Vision. 

  
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 (c) Over-or Underpayment. If the audit is
undisputed and reveals an overpayment, Roche shall reimburse River Vision for the amount of the overpayment within [***] days. If the audit is undisputed and reveals an underpayment, River Vision shall make up such underpayment with the next royalty
payment or, if no further royalty payments are owed to Roche, River Vision shall reimburse Roche for the amount of the underpayment within [***] days. River Vision shall pay for the
out-of-pocket audit costs if the underpayment of River Vision exceeds [***]% of the aggregate amount of royalty payments owed with regard to the royalty statements
subject of the audit. Section 10.1(b) shall apply to this Section 10.4(c), interest to run from the date such audit is reported to the parties. 

(d) Duration of Audit Rights. The failure of Roche to request verification of any royalty calculation within the period during which
corresponding records must be maintained under this Section 10.4 will be deemed to be acceptance of the royalty payments and reports. 
 11.
INTELLECTUAL PROPERTY 
 11.1 Ownership of Patent Rights. River Vision shall own all
River Vision Inventions, Roche shall own all Roche Inventions, and River Vision and Roche shall jointly own all Joint Inventions. River Vision and Roche each shall require all of its employees, agents and consultants to assign all inventions related
to Products made by them to Roche and River Vision, as the case may be. The determination of inventorship for Inventions worldwide shall be in accordance with US inventorship laws. 

11.2 Patent prosecution and maintenance. Roche shall have the first right (but not the obligation) to prepare, file,
prosecute and maintain all Roche Patents at Roche’s sole expense. River Vision shall have the first right (but not the obligation) to prepare, file, prosecute and maintain all River Vision Patents at River Vision’s sole expense. The party
responsible for the filing, prosecution and maintenance of any Roche Patents or River Vision Patents (the “Responsible Party”) shall provide the other party with a reasonable opportunity to review drafts of proposed patent
applications with respect to Patents owned solely by the Responsible Party that claim the manufacture, use or sale of Compound or Product being developed or commercialized by either party, if appropriate, depending on the contents of the submission.
The Responsible Party shall consider in good faith the requests and suggestions of the other party with respect to the content and strategies for such patent applications. For clarity, Roche is not obliged to and River Vision has no right request
Roche to prepare, file, prosecute and maintain general claims of the Roche Patents going beyond the Compound and/or Product or any other IGF-1 R antibody. Notwithstanding anything in this Section 11 to
the contrary, Roche’s rights with respect to River Vision Patents for prosecution, defense, enforcement and otherwise under this Section 11 will extend only to Compound and/or Product in the Field, and further Roche will not seek to
enforce any River Vision Patents without the consent of River Vision. 
 11.3 Assignment of Patents. If Roche is no
longer interested in prosecuting or maintaining any of the Roche Patents, then Roche shall notify River Vision thereof and Roche shall assign such Roche Patents to River Vision (or license on an exclusive basis all claim scope to River Vision if any
such assignment is not possible under applicable patent law), provided that River Vision shall bear the costs for such assignments and for all future costs. All Patent Rights so assigned from Roche to River Vision shall remain Roche Patents as
defined in this Agreement. If River Vision is no longer interested inprosecuting or maintaining any of the River Vision Patents, then River Vision shall notify Roche thereof by at least [***] days prior written notice. 

  
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 11.4 Prosecution of Joint Patent Rights. River Vision shall be the
Responsible Party for preparing, filing, prosecuting or maintaining Joint Patents, with the parties’ sharing equally the expense thereof. River Vision shall not discontinue prosecution or maintenance of Joint Patents without at least [***] days
prior written notice to Roche. If River Vision decides to discontinue prosecution or maintenance of any Joint Patents, Roche shall have the option to continue to prosecute or maintain such Joint Patents, at Roche’s sole expense. 

11.5 Cooperation of the Parties. Each party agrees to cooperate in the preparation, filing and prosecution of any
Patents under this Agreement and in the obtaining of any patent extensions, supplementary protection certificates and the like with respect to any such Patent. Such cooperation includes, but is not limited to: (a) executing all papers and
instruments, or requiring its employees, agents or consultants, to execute such papers and instruments and to enable the Responsible Party to apply for and to prosecute and maintain patent applications in any country; and (b) promptly informing
the Responsible Party of any matters coming to such party’s attention that may affect the preparation, filing, prosecution or maintenance of any such patent applications; and (c) the Responsible Party regularly update the other party on
the status of all Patents, including any dates for action required or due dates for payments. River Vision shall have the right using a form mutually agreed to by the parties to record its exclusive license under the Roche Patents in countries in
the Territory. 
 11.6 Infringement by Third Parties. 

(a) Infringement. Each party shall promptly provide written notice to the other party during the Term of any known infringement or
suspected infringement by a Third Party of any Roche Patents, River Vision Patents (if any) or Joint Patents (if any), or of any invalidity or unenforceability assertion or challenge to any such patents, or of any unauthorized use or
misappropriation of Roche Know-How, and shall provide the other party with all evidence in its possession supporting such infringement, assertion or challenge or unauthorized use or misappropriation. For
clarity, any challenge amounting to a reexamination, interference or opposition will be addressed by Sections 11.2 through 11.5. 
 (b)
Defense and Enforcement. Within a period of [***] days after either party provides or receives such written notice with respect to its Patents (“Decision Period”), the party that has the first right to enforce any such
Patents as set forth on Schedule 11.6(b) (the “First Party”) that are allegedly infringed, in its sole discretion, shall decide whether or not to initiate a suit or take other appropriate action with respect to any allegedly
infringing activities in the Field (including without limitation defending any assertion or challenge) and shall notify the other party in writing of its decision in writing (“Suit Notice”). 

If the First Party for its Patents are allegedly infringed decides to bring a suit or take action with respect to any allegedly infringing activities in the
Field and provides a respective Suit Notice, then such party may immediately commence such suit or take such action. If such party (i) does not in writing advise the other party within the Decision Period that it will commence suit or take
action, or (ii) fails to commence suit or take action within a reasonable time after providing Suit Notice, then the other party shall thereafter have the right to commence suit or take action with respect to any allegedly infringing activities
in the Field and shall provide written notice to the party whose Patents are allegedly infringed of any such suit commenced or action taken by the other party. 

  
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 Upon written request, the party bringing suit or taking action (‘Initiating Party’) shall keep the
other party informed of the status of any such suit or action and shall provide the other party with copies of all substantive documents and communications filed in such suit or action. The Initiating Party shall have the sole and exclusive right to
control any such suit or action, including but not limited to selecting counsel for any such suit or action. If each of the parties elects to be an Initiating Party with respect to the same allegedly infringing activities within the Field, then the
parties shall meet and agree on how to manage the resulting suits and actions (including with respect to the process set forth in Section 11.7). If River Vision is the Initiating Party with respect to the Compound Patent, upon Roche request,
River Vision and Roche shall jointly agree in good faith on the strategy on how to bring suit or take action with respect to such Compound Patent, such discussions to be held in good faith, and failure to agree shall not jeopardize timing regarding
any such suit or action. 
 The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including, without limitation, the
Initiating Party’s attorneys’ fees, damages and court costs. 
 If the Initiating Party believes it reasonably necessary, upon written request the
other party shall join as a party to the suit or action, but shall be under no obligation to participate, except to the extent that such participation is required as the result of its being a named party to the suit or action. Alternatively, at the
Initiating Party’s request, the other party will bring the suit or action in the other party’s name, if the Initiating Party reasonably believes that the Initiating Party does not have standing to bring the suit or action, and in such
event, the Initiating Party will still control the suit or action as provided above. At the Initiating Party’s written request, the other party shall offer reasonable assistance to the Initiating Party in connection therewith at no charge to
the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other party in rendering such assistance. The other party shall have
the right to participate and be represented in any such suit or action by its own counsel at its own expense. 
 The Initiating Party shall not settle,
agree to a consent judgment or otherwise voluntarily dispose of the suit or action without the written consent of the other party, which consent shall not be unreasonably withheld or delayed; provided that if River Vision is the Initiating Party,
any such consent from Roche is not required if River Vision grants a permitted sub-license under Sections 2.5 and 3. 

Except as otherwise agreed by the parties in connection with a cost-sharing arrangement, any recovery realized as a result of litigation described in this
Section 11.6 (whether by way of settlement or otherwise) will be first allocated to reimbursement of unreimbursed legal fees and expenses incurred by the Initiating Party(ies), then toward reimbursement of any unreimbursed legal fees and
expenses of the other party if not an Initiating Party, and then the remainder will be shared between the parties by allocating (i) [***]% to River Vision and [***] to Roche for those Patents infringed where River Vision is the Initiating Party,
(ii) [***]% to Roche and [***] to Roche for those Patents infringed where Roche is the Initiating Party, and (iii) if there are Patents infringed for which River Vision is the Initiating Party for one or more of those Patents and Roche is the
Initiating Party for one or more of those Patents, [***]. 

  
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 (c) Exclusion. For clarity, this Section 11.6 shall not apply to the [***]
Agreement, the [***] Agreement and the [***] Agreement. 
 11.7 Hatch-Waxman. Notwithstanding anything herein to the
contrary, should a party receive a certification for a Product pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417, known as the Hatch-Waxman Act), as amended, or
its equivalent in a country other than the US, then such party shall immediately provide the other party with a copy of such certification. The First Party for any such Patent shall have [***] days from date on which it receives or provides a copy
of such certification to provide written notice to the other party (“H-W Suit Notice”) whether the First Party will bring suit at its expense within a [***] day period from the date of
such certification. Should such [***] day period expire without the First Party bringing suit or providing such H-W Suit Notice, then the other party shall be free to immediately bring suit with respect to
such Patent as the Initiating Party. 
 11.8 Biosimilar or interchangeable biological products. Notwithstanding
anything herein to the contrary, within [***] years after the approval of a Product which has been licensed in the US as a biological product under 42 USC 262(a), and as may be needed from time to time thereafter, the parties shall consult as to
potential strategies with respect to unexpired US Patent Rights which cover the Product; such consultation shall occur at least [***] days before such [***] anniversary. Specifically, in anticipation of a receipt by the Product’s reference
product sponsor (“Reference Product Sponsor”) of a biosimilar or interchangeable product application pursuant to the Biologics Price Competition and Innovation Act of 2009 (Public Law
111-148), the parties will discuss the Reference Product Sponsor’s likely course of action with regard to each such US Patent Right in the procedural steps set forth under 42 USC §262(l), including a
general plan for timely communication between the parties in light of the statutory response deadlines. 
 11.9 Patent
Term Extensions. The parties shall use Commercially Reasonable Efforts to obtain all available patent term extensions, adjustments or restorations, or supplementary protection certificates (“SPCs”, and together with
patent term extensions, adjustments and restorations, “Patent Term Extensions”). Roche shall execute such authorizations and other documents and take such other actions as may be reasonably requested by River Vision to obtain
such Patent Term Extensions, including without limitation designating River Vision as its agent for such purpose as provided in 35 U.S.C. Section 156. All filings for such Patent Term Extensions shall be made by Roche; provided, that in
the event that Roche elects not to file for a Patent Term Extension, Roche shall (a) promptly inform River Vision of its intention not to file and (b) grant the right to file for such Patent Term Extension to River Vision as its
agent, such acts to occur well in advance of any deadlines for applying for any such Patent Term Extensions for River Vision to act thereupon. Each party shall execute such authorizations and other documents and take such other actions as may be
reasonably requested by the other party to obtain such extensions. The parties shall cooperate with each other in gaining patent term restorations, extensions and/or SPCs wherever applicable to such Roche Patents. 

  
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 12. TRADEMARKS AND LABELING 

River Vision shall own all trademarks used on or in connection with Product in the Territory, and shall, at its sole cost, be responsible for procurement,
maintenance, enforcement and defense of all trademarks used on or in connection with Product in the Territory. 
 If requested by Roche and to the extent
permitted by applicable law, all packaging and labeling shall display that the Product has been “licensed from Roche”. 
 13.
REPRESENTATIONS AND WARRANTIES 
 13.1 Mutual representations and
warranties. Each party represents and warrants to the other that, as of the Effective Date: (a) it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other
power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this
Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally binding upon it, enforceable in accordance with its terms, and 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 or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. 

13.2 Roche representations and warranties. Roche represents and warrants to River Vision that, as of the Effective Date:
(a) Roche has not received written notice from any Third Party claiming that the manufacture, use or sale of Compound or Product infringes any Patent of any Third Party; (b) Roche is not aware of any Patent that would be infringed by
Compound in the Field in the Territory by River Vision; (c) Roche is not a party to any legal action, suit or proceeding relating to Compound or Product; (d) Roche has the full right, power and authority to grant all of the right, title
and interest in the licenses, sub-licenses and other rights granted to River Vision under this Agreement; (e) the Roche Patents constitute all of the Patents owned or
in-licensed by Roche or any of its Affiliates that are necessary to develop, commercialize, make, use, sell, offer for sale, and import Compound or Product (other than as disclosed by Roche to River Vision
before the Effective Date); (f) Roche has Control of all the Roche Patents; and (g) the [***] Agreement, the [***] License Agreement and the [***] License Agreement are in full force and effect. 

13.3 Limitations. Except as provided in Section 13.2, Roche makes no representation or warranty that all
intellectual property rights necessary for River Vision to make, have made, use, sell, offer for sale and import the Compound or the Product in the Territory have been granted to River Vision under Section 2. Roche did not perform an exhaustive
and final search for Third Party patents or an evaluation thereof for Compound and technologies relevant under this Agreement. Roche will not keep River Vision updated about further searches or analyses of Third Party patents nor will it keep River
Vision updated about any further developments of any Third Party rights or steps taken or intended to be taken by Roche with regard to such Third Party rights. 

  
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 13.4 Disclaimer. Except as expressly set forth herein and elsewhere in
this Agreement, THE INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED “AS IS” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION
THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE
PRACTICES. 
 13.5 Debarment. River Vision represents and warrants that it has never been debarred under 21 U.S.C.
§335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal
Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event River Vision receives notice of debarment, suspension, sanction,
exclusion, ineligibility or disqualification under the above-referenced statutes, River Vision shall immediately notify Roche in writing and Roche shall have the right, but not the obligation, to terminate this Agreement, effective, at Roche’s
option, immediately or at a specified future date, with the consequences set forth in Section 15.4(a). 
 14. CONFIDENTIALITY;
PUBLICATION 
 14.1 Non-Use and
Non-Disclosure. During the Term of this Agreement and for [***] years thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own
information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, and (iii) not use such Confidential
Information other than for fulfilling its obligations under this Agreement. For the purposes of this Section 14, Roche Know-How shall be considered Confidential Information of both parties. 

14.2 Authorized disclosure. Each party may disclose Confidential Information of the other party as expressly permitted
by this Agreement or if and to the extent such disclosure is reasonably necessary in the following instances: 
 (a) filing or
prosecuting Patents as permitted by this Agreement; 
 (b) prosecuting or defending litigation as permitted by this Agreement; 

(c) complying with applicable court orders or governmental regulations; and 

(d) disclosure to (i) Affiliates, (ii) for River Vision, NRM and potential or actual subcontractors, Partners, assignees and Change
of Control counterparties, (iii) Third Parties in connection with due diligence or similar investigations by such Third Parties, and (iv) disclosure to potential Third Party investors or financial institutions or advisors (including,
without limitation, for River Vision, on behalf of NRM), provided, in each case, that any such Third Party agrees to be bound by obligations of confidentiality and non-use, such obligations of confidentiality
to contain a confidentiality period of at least [***] years or [***] but not less than [***] years. 

  
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 LICENSE AGREEMENT 

 

 Notwithstanding the foregoing, in the event a party is required to make a disclosure of the other
party’s Confidential Information pursuant to Sections 14.2(b) or 14.2(c), it will, except where impracticable, give reasonable advance notice to the other party of such disclosure and use efforts to secure confidential treatment of such
information at least as diligently as such party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the parties agree to take all reasonable action to avoid disclosure of Confidential
Information hereunder. The parties will consult with each other on the provisions of this Agreement to be redacted in any filings made by the parties with the Securities and Exchange Commission (or any other relevant agency or body related to a
regulated stock exchange) or as otherwise required by law. 
 14.3 Publications. River Vision shall have the right to
publish any papers regarding results and other information regarding Compound and/or Product, including oral presentations and abstracts. River Vision shall provide Roche with a copy of any proposed papers at least [*** days prior to submission for
publication so as to provide Roche with an opportunity to review drafts of the proposed papers. River Vision shall consider in good faith the requests and suggestions of Roche. 

Roche shall have the right to publish (i) the results of past and ongoing studies and (ii) any particular work that must be disclosed by law. Roche shall
provide River Vision with a copy of any proposed papers at least [***] days prior to submission for publication so as to provide River Vision with an opportunity to review drafts of the proposed papers. Roche shall consider in good faith the
requests and suggestions of River Vision. 
 14.4 Use of name or trademarks. Neither party shall use the other
party’s or its Affiliates’ names, with respect to Roche including but not limited to the compound code name “[***]”,”[***]” or “[***]”, or trademarks for publicity or
advertising purposes, except with the prior written consent of the other party. 
 14.5 Publicity. It is understood
that the parties intend to issue a joint press release announcing the execution of this Agreement at a mutually agreed upon time (the “Initial Press Release”). Thereafter both parties may desire or be required to issue
subsequent press releases relating to the Agreement or activities hereunder. The parties agree to consult with each other reasonably and in good faith with respect to the text and timing of such subsequent press releases prior to the issuance
thereof, provided that a party may not unreasonably withhold or delay consent to such subsequent releases, and that either party may issue such subsequent press releases as it determines, based on advice of counsel, are reasonably necessary to
comply with laws or regulations or for appropriate market disclosure. In addition, following the Initial Press Release announcing this Agreement, either party shall be free to disclose, without the other party’s prior written consent, the
existence of this Agreement, the fact that River Vision has taken a license from Roche to the Compound and Product for development and commercialization in the Field, and those terms of the Agreement which have already been publicly disclosed in
accordance herewith. 
 15. TERM 

15.1 Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated pursuant to Section 15.2,
continue until the expiration of the Royalty Term (the “Term”). 

  
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 15.2 Termination. Subject to Section 15.4: 

(a) Breach. A party (“Non-Breaching Party”) shall have the right to
terminate this Agreement in its entirety in the event the other party (“Breaching Party”) is in breach of any of its obligations under this Agreement. The non-Breaching Party shall
provide written notice to the Breaching Party, which notice shall identify the breach. The Breaching Party shall have a period of ninety (90) days after such written notice is provided to cure such breach (“Peremptory Notice
Period”). If such breach is not cured within the Peremptory Notice Period, this Agreement shall effectively terminate, unless there exists a bona fide dispute as to whether such breach occurred or such breach has been cured, whereupon
such Peremptory Notice Period shall be tolled and shall not expire until such dispute is settled pursuant to Section 17, whereupon thereafter the Breaching Party may attempt to cure such breach if in the wrong.
Non-payment by River Vision is considered a breach under this Agreement. 
 (b) Insolvency. A
party shall have the right to terminate this Agreement, if the other party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the party that
incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof. 

(c) Challenging the Roche Patent Rights. If River Vision is challenging the validity of the Roche Patent Rights, then Roche shall have
the right to terminate this Agreement in its entirety with immediate effect. Section 15.4(a) shall apply mutatis mutandis. 

15.3 Termination by River Vision without a Cause. If River Vision wishes to terminate the Agreement, River Vision shall
notify Roche in writing and Roche and River Vision shall discuss in good faith methods to avoid such termination. If however, the Parties cannot agree on a method to avoid such termination within thirty (30) days of such notice, and River
Vision continues to wish to terminate this Agreement, then the following shall apply: River Vision shall have the right to terminate this Agreement in its entirety within six (6) months of such notice before First Commercial Sale of the Product
or within nine (9) months of such notice after the First Commercial Sale of the Product. The effective date of termination under this Section 15.3 shall be the date six (6) months (or nine (9) months as the case may be) after
River Vision provides such notice to Roche. 
 15.4 Consequences of Breach and Termination 

(a) Breach by River Vision 

(i) Both parties shall discuss in good faith and shall attempt to agree on the extent of damages caused by River Vision’s breach of its obligations under
this Agreement, and appropriate compensation for damages as may be applicable. Roche shall retain all its remedies as against River Vision in addition to those provided in this Agreement (including, without limitation, when clause (ii) below
applies). Notwithstanding anything in this Section 15 to the contrary, if River Vision disputes the breach as specified in Section 15.2(a) and/or any remedy therefor, then in lieu of any of the remedies specified below in clause
(ii) of this Section 15.4(a), the parties agree to have the ICC under Section 17 determine (1) whether any breach has occurred (and if any such breach is found to have occurred, subject to the subsequent cure period provided in
Section 15.2(a)) and (2) an appropriate remedy in proportion to any such uncured breach. For clarity, Roche shall not be required to seek, before the ICC or otherwise, to terminate this Agreement upon any breach by River Vision. 

  
  

28 

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 (ii) If River Vision elects not to dispute the alleged breach and/or the remedy therefor as provided in
clause (i) above, then the following shall apply: 
 (a) Roche shall notify River Vision its decision on whether or not it shall
terminate this Agreement within ninety (90) days after the expiration of the Peremptory Notice Period. Such notice shall contain the information to which extent Roche wishes to continue the development and commercialization of the Compound
and/or Product. 
 (b) Upon any termination by Roche for breach by River Vision, all rights and licenses granted by Roche to River Vision
under this Agreement shall also terminate on the effective date of termination. River Vision shall, upon Roche’s written request, to the extent River Vision has the right to do so, assign and transfer to Roche, [***] all regulatory filings and
approvals, Product specific- trademarks, and all data, including clinical data, samples, materials and information, in River Vision’s possession and Control related to Product necessary for the development and commercialization of the Product.
Upon request of Roche, River Vision shall assign clinical trial agreements to the extent permitted. 
 (c) Roche shall, upon such transfer,
have the right to disclose such filings, approvals and data to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacturing or sale of Product, (ii) Third Parties acting on behalf of
Roche, its Affiliates or licensees, to the extent reasonably necessary solely for the development, manufacture, or sale of Product, and (iii) Third Parties to the extent reasonably necessary to market Product. 

(d) Roche shall have [***] solely for Roche, its Affiliates or licensees to develop, manufacture and have manufactured, use offer to sell,
sell, promote, export and import the applicable Products in the Territory. Upon request of Roche, any license agreements between River Vision and a Third Party relating to Product shall be either assigned to Roche, or if this is not possible, sub-licensed to Roche to the extent permitted under the then prevailing conditions. 

(b) Breach by Roche 
 (i)
Both parties shall discuss in good faith and shall attempt to agree on the extent of damages caused by Roche’s breach of its obligations under this Agreement, and appropriate compensation for damages as may be applicable. River Vision
shall retain all its remedies as against Roche in addition to those provided in this Agreement (including, without limitation, when clause (ii) below applies). Notwithstanding anything in this Section 15 to the contrary, if Roche
disputes the breach as specified in Section 15.2(a) and/or any remedy therefor, then in lieu of any of the remedies specified below in clause (ii) of this Section 15.4(b), the parties agree to have the ICC under Section 17
determine (1) whether any breach has occurred (and if any such breach is found to have occurred, subject to the subsequent cure period provided in Section 15.2(a)) and (2) an appropriate remedy in proportion to any such uncured
breach. For clarity, River Vision shall not be required to seek, before the ICC or otherwise, to terminate this Agreement upon any breach by Roche. 

  
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 (ii) If Roche elects not to dispute the alleged breach or the remedy therefor as provided in clause (i)
above, then the following shall apply: 
 (a) Upon any breach by Roche for which River Vision has the right to terminate this Agreement under
Section 15.2, River Vision shall have the right to terminate this Agreement in accordance with Section 15.2, with the consequences set forth in Section 15.4(c). If River Vision does not practice its aforementioned right to terminate,
then River Vision may retain the rights and licenses granted by Roche under this Agreement after the expiration of the Peremptory Notice Period and this Agreement shall not terminate but rather shall continue in full force and effect. River Vision
shall notify Roche its decision on whether or not it shall terminate this Agreement within ninety (90) days after the expiration of the Peremptory Notice Period. 

(c) Termination by River Vision without Cause 

(i) Roche shall inform River Vision within thirty (30) days after the notice of termination under this Section 15.4(c) whether or not and to which
extent Roche wishes to continue the development and commercialization of the Compound and/or Product. 
 (ii) Upon any termination by River Vision under this
Section 15.4(c), all rights and licenses granted by Roche to River Vision under this Agreement shall terminate in their entirety. 
 (iii) River Vision
shall, upon Roche’s written request, to the extent it has the right to do so, assign to Roche, [***] all Product regulatory filings and approvals and Product-specific trademarks (including but not limited to data, including clinical data,
samples, materials and information) in River Vision’s possession and Control. If requested by Roche, River Vision shall assign clinical trial agreements to the extent permitted. 

Roche shall have [***] solely for Roche, its Affiliates or licensees to develop, have developed, commercialize, have commercialized, make, have made, use,
have used, sell, have sold, offer for sale, have offered for sale, import and have imported the applicable Products in the Territory. 
 Roche shall, upon
such transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of Product; (ii) Third
Parties acting on behalf of Roche, its Affiliates or licensees, to the extent reasonably necessary solely for the development, manufacture, or sale of Product, or (iii) Third Parties to the extent reasonably necessary to market Product. 

Upon request of Roche, any agreements between River Vision and a Third Party relating to Product shall be either assigned to Roche, or if this is not
possible, sub-licensed to Roche to the extent permitted under the then prevailing conditions. 

15.5 Other Obligations 

(a) Obligations Related to Ongoing Activities 

(i) From the date of notice of termination until the effective date of termination, this Agreement shall remain in full force and effect 

(ii) If Roche has provided notice to River Vision pursuant to Section 15.4(c)(i) that it does not wish to continue the development and commercialization
of the Compound and/or Product, then River Vision (A) has the right to cancel all ongoing obligations and (B) shall complete all non-cancellable obligations at its own expense. 

  
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 LICENSE AGREEMENT 

 

 (iii) If Roche has provided notice to River Vision pursuant to Section 15.4(c) that Roche wishes to
continue the development and/or commercialization of the Compound and/or Product, then, at Roche’s request, River Vision shall [***] continue non-clinical activities ongoing as of the date of notice of
termination (for clarity, the treatment of clinical trials is addressed below). 
 (iv) If Roche has provided notice to River Vision pursuant to Section
15.4(c) that Roche wishes to continue the development and/or commercialization of the Product, then, upon the request of Roche, River Vision shall complete [***], any clinical studies related to the Product that are being conducted under its IND (or
equivalent) for the Product and are ongoing as of the notice of termination; provided, however, that Roche agrees [***] in completing such clinical studies and provided further that each of River Vision and Roche in their respective reasonable
judgment has concluded that completing any such clinical studies does not present a unreasonable risk to patient safety. 
 (v) In any case, after the
effective date of termination, River Vision shall not have any obligation to perform and/or complete any new activities or to make any payments for performing or completing any new activities under this Agreement, except as expressly stated in
Section 15.5(a)(iii). 
 (b) Obligations Related to Manufacturing. If (i) Roche has provided notice to River Vision that
Roche wishes to continue the development and/or commercialization of the Product, and (ii) Product is then being manufactured, then, upon the request of Roche, River Vision shall use Commercially Reasonable Efforts to manufacture and supply (or
have manufactured or supplied, as the case may be) Product to Roche for a period which shall not exceed [***] months from the effective date of the termination of this Agreement at a price to be agreed by the parties in good faith. Roche shall use
Commercially Reasonable Efforts to take over the manufacturing as soon as possible after the effective date of termination. 
 (c) Royalty
and Payment Obligations 
 Expiration or termination of this Agreement (or any provision hereof) for any reason shall be without prejudice to any right
that shall have accrued to the benefit of a party prior to such expiration or termination, including without limitation damages arising from any breach under this Agreement. 

Termination of this Agreement by a party, for any reason, shall not release River Vision from any obligation to pay royalties or make any payments to Roche
which are due and payable prior to the effective date of termination. Termination of this Agreement by a party, for any reason, will release River Vision from any obligation to pay royalties or make any payments to Roche which would otherwise become
due or payable on or after the effective date of termination. 
 (d) Survival. Expiration or termination of this Agreement shall not relieve a party
from any obligation that is expressly indicated to survive such expiration or termination. In addition to the termination consequences set forth in Section 15.4, the following provisions shall survive termination or expiration of this
Agreement: 2.8 (Freedom-to-operate); 11. Intellectual Property; 14. Confidentiality/Publication; 16. Indemnification, 17. Dispute Resolution, Governing Law and
Jurisdiction, and the following provisions of 18. General Provisions: 18.2, 18.3, 18.6, 18.7, 18.8, 18.10, 18.11 and 18.12. 

  
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 LICENSE AGREEMENT 

 

 16. INDEMNIFICATION 

16.1 Roche indemnification. Roche hereby agrees to save, defend, indemnify and hold harmless River Vision and its
officers, directors, employees, consultants and agents (“River Vision Indemnitees”) from and against any and all losses, damages, liabilities, expenses and costs, including reasonable legal expense and attorneys’ fees
(“Indemnified Losses”), to which any such River Vision Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party to the extent such Indemnified Losses arise out of the
breach by Roche of any obligation, representation, warranty, covenant or agreement made by it under this Agreement, except to the extent such Indemnified Losses result from the negligence or willful misconduct of any River Vision Indemnitee
(including without limitation any item subject to indemnification by River Vision under Section 16.2). 
 16.2 River
Vision indemnification. River Vision hereby agrees to save, defend, indemnify and hold harmless Roche and its officers, directors, employees, consultants and agents (“Roche Indemnitees”) from and against any and all
Indemnified Losses, to which any such Roche Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party to the extent such Indemnified Losses arise out of (i) the breach by River Vision of any
representation, warranty, covenant or agreement made by it under this Agreement, or (ii) the development, manufacture, use, handling, storage, sale or other disposition of the Compound and/or any Product by River Vision or any of its Affiliates
or Partners (including but not limited to (1) Product liability claims and (2) infringement of Third Party patents, other than those for this clause (2) Patents sub-licensed to River Vision by
Roche under the [***] Agreement, the [***] Agreement or the [***] Agreement or any in-licensed Roche Patents provided that River Vision has complied with the applicable terms of this Agreement), except to the
extent such Indemnified Losses result from the negligence or willful misconduct of any Roche Indemnitee (including without limitation any item subject to indemnification by Roche under Section 16.1). 

16.3 Control of defense. In the event an River Vision Indemnitee or Roche Indemnitee (as the case may be) seeks
indemnification under Section 16.1 or 16.2, it shall inform the other party (the “Indemnifying Party”) of a claim as soon as reasonably practicable after it receives notice of the claim, shall permit the Indemnifying
Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration), and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim,
provided that the Indemnifying Party shall not settle any such claim without the prior written consent of any affected Roche Indemnitee or River Vision Indemnitee (as the case may be), if such settlement contains any admission of fault of such River
Vision Indemnitee or Roche Indemnitee (as the case may be). 

  
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 LICENSE AGREEMENT 

 

 17. DISPUTE RESOLUTION, GOVERNING LAW
AND JURISDICTION 
 17.1 Dispute resolution. Any dispute arising under or relating
to the parties rights and obligations under this Agreement will be referred to the Chief Executive Officer of River Vision or his designee and the Head of Roche Partnering of Roche with authority to resolve such dispute, for resolution. In the event
the two individuals referred to in the preceding sentence are unable to resolve such dispute within [***] days of such dispute being referred to the officers, then, upon the written request of either party to the other party, the dispute shall be
addressed as provided in Section 17.2. 
 17.2 Governing law and jurisdiction. 

This Agreement shall be governed by and construed in accordance with the laws of Switzerland, without reference to its conflict of laws principles and shall
not be governed by the United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention). 
 If a dispute cannot be resolved
in application of Section 17.1, then such dispute shall be finally settled under the rules of arbitration of the International Chamber of Commerce (“ICC”) by three arbitrators. 

Each party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within [***] days of being
requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within [***] days of being requested to do so, the other party shall request the ICC court to make such appointment. 

The arbitrators nominated by the parties shall, within [***] days from the appointment of the arbitrator nominated in the answer to the request for
arbitration, and after consultation with the parties, agree and appoint a third arbitrator, who will act as a chairman of the arbitral tribunal. Should such procedure not result in an appointment within the [***] day time limit, either party shall
be free to request the ICC court to appoint the third arbitrator. 
 Where there is more than one claimant and/or more than one respondent, the multiple
claimants or respondents shall jointly appoint one arbitrator. In other respects the provisions of this Section 17.1 shall apply. 
 If any
party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this Section 17.1. 

Basel, Switzerland, shall be the seat of the arbitration. 
 The
language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation. 

This arbitration agreement does not preclude either party seeking conservatory or interim measures from any court of competent jurisdiction including, without
limitation, the courts having jurisdiction by reason of either party’s domicile. Conservatory or interim measures sought by either party in any one or more jurisdictions shall not preclude the arbitral tribunal granting conservatory or interim
measures. Conservatory or interim measures sought by either party before the arbitral tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures. 

In the event that any issue shall arise which is not clearly provided for in this arbitration agreement the matter shall be resolved in accordance with the
ICC arbitration rules. 

  
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 18. GENERAL PROVISIONS 

18.1 No implied licenses. No right or license under any Patents or Know-How is
granted or shall be granted by implication. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement. Each party hereby expressly reserves the right to practice, and to grant licenses under, the
Patents and Know-How Controlled by such party for any and all purposes other than as expressly provided herein or for the specific purposes for which the other party has been granted an exclusive license under
this Agreement. 
 18.2 Relationship between the parties. The parties’ relationship, as established by this
Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture or similar business relationship between the parties. Neither party is a legal representative of the other party and neither party
can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other party for any purpose whatsoever. 

18.3 Non-waiver. The failure of a party to insist upon strict performance of any
provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any
waiver by a party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such party. 

18.4 Assignment. Neither party shall have the right to assign the present Agreement or any part thereof to any Third
Party other than Affiliates without the prior written approval of the other Party, such approval not to be unreasonably withheld or delayed. 

18.5 Change of Control. River Vision shall not have the right to undergo a Change of Control without the prior written
approval of Roche, such approval not to be unreasonably withheld or delayed. For purposes of this Agreement, “Change of Control” shall mean, with respect to River Vision, (i) a merger, reorganization or consolidation
involving River Vision in which the members of River Vision, immediately prior to the merger, reorganization or consolidation, would not, immediately after the merger, reorganization or consolidation, beneficially own (directly or indirectly)
membership interests representing in the aggregate more than fifty percent (50%) of the combined voting power of the entity issuing cash or securities in the merger, reorganization or consolidation (or of its ultimate parent entity, if any), or
(ii) a person or entity becomes the beneficial owner of more than fifty percent (50%) of the voting securities of River Vision, other than directly from River Vision; however, “Change of Control” will not include any transaction
effected for equity or debt financing purposes pursuant to which River Vision receives cash therefor, provided River Vision does not grant any sublicense of the rights granted to River Vision by Roche in Section 2.1(a) as part of such
transaction. For purposes of this Section 18.4 and the last sentence of Section 2.5, River Vision shall have the right to provide the identity of the counterparty to the proposed Partner Agreement or Change of Control, and Roche shall
indicate within [***] business days if Roche approves such proposed transaction (and if Roche fails to reply in such [***]-day period, then such approval will be deemed given). 

  
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 18.6 No Third Party beneficiaries. This Agreement is neither expressly
nor impliedly made for the benefit of any party other than those executing it. 
 18.7 Severability. If, for any
reason, any part of this Agreement is adjudicated invalid, unenforceable or illegal by a court of competent jurisdiction, then such adjudication shall not, to the extent feasible, affect or impair, in whole or in part, the validity, enforceability
or legality of any remaining portions of this Agreement. All remaining portions shall remain in full force and effect as if the original Agreement had been executed without the invalidated, unenforceable or illegal part. 

18.8 Notices. Any notice to be given under this Agreement must be in writing and delivered either in person, by any
method of mail (postage prepaid) requiring return receipt, or by overnight courier or facsimile confirmed thereafter by any of the foregoing, to the party to be notified at its address(es) given below, or at any address such party has previously
designated by prior written notice to the other. Notice shall be deemed sufficiently given for all purposes upon the earliest of: (a) the date of actual receipt; (b) if mailed, [***] days after the date of postmark; or (c) if
delivered by overnight courier, the next business day the overnight courier regularly makes deliveries. 
 If to River Vision, notices must be addressed to:

 River Vision, LLC 
 Narrow
River Management 
 One Rockefeller Plaza. Ste. 1204 

New York, NY 10020 U.S.A. 

Attention: David Madden, Principal 

Facsimile: [***] 
 If to Roche, notices must be
addressed to: 
 Hoffmann-La Roche Inc. 

340 Kingsland Street 
 Nutley,
NJ 07110, USA 
 Attention: Corporate Secretary 

Facsimile: [***] 
 And: 

F.Hoffmann-La Roche Ltd 

Grenzacherstrasse 124 
 CH-4070 Basel 
 Switzerland 

Attention: Legal Department 

Facsimile: [***] 
 In the event of a change of
notice address, recipient or both, a party shall provide the other party written notice pursuant to this Section 18.8 setting forth the new address and/or recipient, as appropriate. 

  
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 18.9 Force majeure. Except for the obligation to make payment when
due, each party shall be excused from liability for the failure or delay in performance of any obligation under this Agreement by reason of any event beyond such party’s reasonable control including but not limited to Acts of God, fire, flood,
explosion, earthquake, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw materials, any strike or labor
disturbance, or any other event similar to those enumerated above. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the party has not caused
such event(s) to occur. Notice of a party’s failure or delay in performance due to force majeure must be given to the other party within [***] days after its occurrence. All delivery dates under this Agreement that have been affected by force
majeure shall be tolled for the duration of such force majeure. In no event shall any party be required to prevent or settle any labor disturbance or dispute. 

18.10 Interpretation. All references to days in this Agreement shall mean calendar days, unless otherwise specified.
This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral or other communications
between the parties regarding this Agreement shall be in the English language. All headings in this Agreement are for convenience only and shall not affect the meaning of any provision hereof. “Herein,” “hereby,”
“hereunder,” “hereof” and other equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used. All definitions set forth herein shall be deemed
applicable whether the words defined are used herein in the singular or the plural. 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. 
 18.11
Binding Effect. This Agreement shall inure to the benefit of and be binding upon the parties, their Affiliates, and their respective successors and assigns. 

18.12 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an
original document, and all of which, together with this writing, shall be deemed one instrument. 
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 IN WITNESS WHEREOF, the
parties have executed this LICENSE AGREEMENT as of the date first above written. 
  

					
	F. HOFFMANN-LA ROCHE LTD	 		 	
			
	By: /s/ Andrew
Jefferson                                        
                    	 		 	By: /s/ Dr. Melanie Frey
Wick                                         
           
	Name: Andrew Jefferson	 		 	Name: Dr. Melanie Frey Wick
	Title: Global Licensing Director	 		 	Title: Legal Counsel
			
	Date: 23/6/11	 		 	Date: June 23, 2011
			
	F. HOFFMANN-LA ROCHE LTD	 		 	RIVER VISION LLC
			
		 		 	 By: NARROW RIVER MANAGEMENT, LP

 

	By: /s/ Frank J.
D’Angelo                                       
                   	 		 	MANAGING MEMBER
	Name: Frank J. D’Angelo	 		 	
	Title: V.P.	 		 	By: /s/ D.
Madden                                        
                                
		 		 	Name: D. Madden
	Date:	 		 	Title: Principal
			
		 		 	Date:

 LICENSE AGREEMENT 

 

 Appendix 1 

Compound 
 teprotumumab is a human IgG1 antibody binding to
IGFIR [***] 
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 Appendix 2 

Roche Patents 
 [***] 

 

  
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 Appendix 3 

Roche Know-How: 

[***] 
  

  
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 Appendix 4 

River Vision Studies: 
 [***] 

  
  

 LICENSE AGREEMENT 

 

 Supply of Drug Product and Supported Shelf Life under Sections 6.1(b) and 6.1(c): 

River Vision will send a written order to Roche to ship Drug Product with no less than [***] months lead time from the delivery date. 

The order shall contain: (a) the order number, (b) quantity of Drug Product vials, (c) invoicing address and (d) delivery date. Roche shall deliver Drug
Product according to Table I EXW (Incoterms 2000) to the delivery address named by River Vision. The delivery address for the material shall be communicated to Roche no fewer than [***] days prior to the agreed delivery date. 

With each shipment of Drug Product, Roche will send the packing list, the Certificate of Analysis for the batches included in the shipment, the current
Material Safety Data Sheet and a pro forma invoice. In addition, Roche will provide River Vision with the documents listed in Table II. Roche guarantees that it has manufactured Product in conformity with the Product specifications, all applicable
laws and regulations, and in accordance with cGMP. 
 [***] 

  
 ***Certain Confidential
Information Omitted 
  

 LICENSE AGREEMENT 

 

 Appendix 5 

Redacted copy of [***] Agreement 
 See attached. 

[Remainder of this page intentionally left blank.] 
  

  
 ***Certain Confidential
Information Omitted 
  

 LICENSE AGREEMENT 

 

 Appendix 6 

Redacted copy of [***] Agreement 
 See attached. 

[Remainder of this page intentionally left blank.] 
  

  
 ***Certain Confidential
Information Omitted 
  

 LICENSE AGREEMENT 

 

 Appendix 7 

Redacted copy of [***] Agreement 
 See attached. 

[Remainder of this page intentionally left blank.] 
  

  
 ***Certain Confidential
Information Omitted 
  

 LICENSE AGREEMENT 

 

 Schedule 11.6(b) 

Patents and First Parties 
 [***] 

[Remainder of this page intentionally left blank.] 
  

  
 ***Certain Confidential
Information Omitted 
  

 Amendment No 1 to License Agreement 

THIS AMENDMENT NO 1. TO LICENSE AGREEMENT
(“Amendment”) is entered into as of the 19th of November, 2012 (“Effective Date”) by and among: 

F. HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. (“Roche
Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 
 and 

RIVER VISION LLC, a limited liability company organized and existing under the laws of Delaware,
with its principal office at One Rockefeller Plaza, New York NY, 10020, U.S.A. (“River Vision”). 

WHEREAS, River Vision and Roche wish to amend the agreement to as follows: 

 

	I.	 Section 2.4 shall be deleted and replaced by the following 

“2.4. Sub-Contractors. River Vision has the right to
sub-contract the work performed under this Agreement. Any sub-contract agreement shall include the right to disclose (i) a copy of the Agreement and confidential
information to Roche and (ii) the right to assign the agreement to Roche, including the right to transfer of the ownership of data, information and results arising therefrom to Roche to the same extent as to River Vision. 

 

	II.	 Section 2.5 shall be deleted and replace by the following: 

“2.5 Right to enter into a Partner Agreement with Third Parties. Subject to Roche’s rights under Section 3, River Vision
shall have the right to enter into a Partner Agreement, including but not limited to granting sublicenses to Partners under its rights granted under Section 2.1 and Section 2.2. Any rights granted to a Partner under this Agreement shall be
solely to the extent necessary to develop, commercialize, make, use, offer for sale, sell or import (and have others do the same) Compound and/or Product in the Field in the Territory. River Vision shall ensure that all of the applicable terms and
conditions of this Agreement, including the obligations under the [***] Agreement, the [***] Agreement and the [***] Agreement, shall apply to the Partner under the Partner Agreement to the same extent as they apply to River Vision for all purposes.
River Vision assumes full responsibility for the performance of all obligations and observance of all terms so imposed to the Partner under such Partner Agreement and shall itself account to Roche for all payments due under this Agreement. The
Partner of River Vision shall have no right to further sub-license rights to develop and commercialise the Compound or Product to a Third Party, with the understanding that
co-promotion or distribution or other marketing arrangements are permitted. 
 Any sublicenses
granted by River Vision to a Partner under the [***] Agreement, the [***] Agreement and the [***] Agreement shall be subject to prior approval of Roche. For clarity, River Vision is free to sub-contract any rights under such agreements. 

River Vision shall disclose a copy of the draft Partner Agreement to Roche, subject to redaction of financial terms. 

  
 ***Certain Confidential
Information Omitted 

	III.	 Section 18.4 of the Agreement shall be deleted and replaced by the following: 

“Section 18.4. Assignment. Neither party shall have the right to assign the present Agreement or any part thereof to any Third
Party other than (I) Affiliates or (11) in connection with a Change of Control as contemplated by Section 18.5, without the prior written approval of the other Party, such approval not to be unreasonably withheld or delayed.’

  

	IV.	 Section 18. 5 of the Agreement shall be deleted and replaced by the following:

 “Section 18.5. Change of Control. Subject to Roche’s right of first offer under Section 3 hereof,
River Vision shall have the right to undergo a Change of Control. For purposes of this Agreement, “Change of Control shall mean, with respect to River Vision, (i) a merger, reorganization or consolidation involving River Vision in which
the members of River Vision, immediately prior to the merger, reorganization or consolidation, would not, Immediately after the merger, reorganization or consolidation, beneficially own (directly or Indirectly) membership interests representing in
the aggregate more than fifty percent (50%) of the combined voting power of the entity Issuing cash or securities in the merger, reorganization or consolidation (or of Its ultimate parent entity, If any), or (ii) a person or entity
becomes the beneficial owner of more than fifty percent (50%) of the voting securities of River Vision, other than directly from River Vision; however, “Change of Control” will not Include any transaction effected for equity or debt
financing purposes pursuant to which River Vision receives cash therefor, provided River Vision does not grant any sublicense of the rights granted to River Vision by Roche as part of such transaction.’ 

 

	V.	 Capitalized terms shall have the same meaning as defined in the Agreement. 

 

	VI.	 Except as expressly stated herein, no other changes are made to tie Agreement and all other terms and
conditions of the Agreement remain in full force and effect 

  

	VII.	 This Amendment enters into effect on the Effective Date. 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT
BLANK.] 

 IN WITNESS WHEREOF, the parties have
executed this AMENDMENT NO. 1 TO THE LICENSE AGREEMENT as of the date first above written. 

F. HOFFMANN-LA ROCHE LTD 

 

									
	By:	 	 /s/ Christophe Carissimo
	  		  	By:	  	 /s/ Dr. Melanie Frey Wiek

	Name:	 	Christophe Carissimo	  		  	Name:	  	Dr. Melanie Frey Wiek
	Title:	 	Global Licensing Director	  	    	  	Title:	  	Legal Counsel
			
	Date: Nov 19, 2012	  		  	Date: November 19, 2012
			
	HOFFMANN-LA ROCHE INC.	  		  	RIVER VISION LLC
				
		 		  		  	BY: NARROW RIVER MANAGEMENT, LP
				
	By:	 	 /s/ Joseph S. McCracken
	  		  	MANAGING MEMBER
	Name:	 	Joseph S. McCracken	  		  		  	
	Title:	 	Vice President	  		  		  	
				
	Date: November 19, 2012	  		  	By:	  	 /s/ D. Madden

		 		  		  	Name:	  	D. Madden
		 		  		  	Title:	  	Principal
				
		 		  		  	Date: 11/19/2012

 Amendment No 2 to License Agreement 

THIS AMENDMENT NO. 2 TO LICENSE AGREEMENT
(“Amendment”) is entered into as of the 1st of February 2013 (“Effective Date”) by and among: 

F.HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. (“Roche
Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 
 and 

RIVER VISION DEVELOPMENT CORP., a corporation organized and existing under the laws of
Delaware, with its principal office at One Rockefeller Plaza, New York NY, 10020, U.S.A. 
 WHEREAS,
River Vision Development Corp. is successor in interest to River Vision LLC and River Vision Development Corp. and Roche wish to amend the agreement to as follows: 
  

	I.	 The table “II. Material” in Process, Manufacturing Know how on page 61 of Appendix 3 shall be amended
by the addition of the following after the existing table under the titles 

 [***] 

 
  

  
 ***Certain Confidential
Information Omitted 

	II.	 Capitalized terms shall have the same meaning as defined in the Agreement. 

 

	III.	 Except as expressly stated herein, no other changes are made to the Agreement and all other terms and
conditions of the Agreement remain in full force and effect. 

	IV.	 This Amendment enters into effect on the Effective Date. 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT
BLANK.] 

 IN WITNESS WHEREOF, the parties have
executed this AMENDMENT NO. 2 TO THE AGREEMENT as of the date first above written. 

 

									
	F. HOFFMANN-LA ROCHE LTD	 	        	 		 	
					
	By:	 	 /s/ Christoph Sarry
	 		 	By:	 	 /s/ Melanie Frey Wick

	Name:	 	Dr. Christoph Sarry	 		 	Name:	 	Dr. Melanie Frey Wick
	Title:	 	Global Alliance Director	 		 	Title:	 	Legal Counsel
			
	Date: 14/02/2013	 		 	Date: February 14, 2013
			
	HOFFMANN-LA ROCHE INC.	 		 	 RIVER VISION DEVELOPMENT CORP.

					
	By:	 	 /s/ Joseph S. McCracken
	 		 	By:	 	 /s/ D Madden

	Name:	 	Joseph S. McCracken	 		 	Name:	 	D Madden
	Title:	 	Vice President	 		 	Title:	 	Chief Executive Officer
			
	Date: 21-Feb-2013	 		 	Date: 5 February 2013

  

			
	Apprv’d As To Form LAW DEPT.
		
	By	 	 /s/ MDM

 Amendment No 3 to License Agreement 

THIS AMENDMENT NO. 3 TO LICENSE AGREEMENT
(“Amendment”) is entered into as of the 1st of February 2013 (“Effective Date”) by and among: 

F. HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. (“Roche
Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 
 and 

RIVER VISION DEVELOPMENT CORP., a limited liability company organized and existing under
the laws of Delaware, with its principal office at One Rockefeller Plaza, Suite 1204, New York, NY, 10020, U.S.A. (“RV”). 

WHEREAS, River Vision and Roche wish to amend the agreement as follows: 

 

	I.	 The table “II. Material” in Process, Manufacturing Know how on page 61 of Appendix 3 shall be amended
by the addition of the following table after the existing table under the titles 

  

	
	 [***]

  
  

  
 ***Certain Confidential
Information Omitted 

  

	
	 [***]

 IN WITNESS WHEREOF, the parties have executed this
AMENDMENT NO. 3 TO THE AGREEMENT as of the date first above written. 

 

									
	F. HOFFMANN-LA ROCHE LTD	 	                	 		 	
					
	By:	 	 /s/ Christophe Carissimo
	 		 	By:	 	 /s/ Melanie Frey Wick

	Name:	 	Christophe Carissimo	 		 	Name:	 	Dr. Melanie Frey Wick
	Title:	 	Global Head Transaction Excellence	 		 	Title:
                                    
			
	Date: May 31, 2013	 		 	Date: May 31, 2013
			
	HOFFMANN-LA ROCHE INC.	 		 	RIVER VISION DEVELOPMENT CORP.
					
	By:	 	 /s/ John P. Parise
	 		 	By:	 	 /s/ D Madden

	Name:	 	John P. Parise	 		 	Name:	 	D Madden
	Title:	 	Authorized Signatory	 		 	Title:	 	CEO
			
	Date: June 4, 2013	 		 	Date: 6/11/13

  

			
	Apprv’d As To Form LAW DEPT.
		
	By	 	 /s/ MM

  

  
 ***Certain Confidential
Information Omitted 

 Amendment No 4 to License Agreement 

THIS AMENDMENT NO. 4 TO LICENSE AGREEMENT
(“Amendment”) is entered into as of the 21st of October 2013 (“Effective Date”) by and among: 

F. HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley, New Jersey 07110, U.S.A. (“Roche
Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 
 and 

RIVER VISION DEVELOPMENT CORP., a limited liability company organized and existing under
the laws of Delaware, with its principal office at One Rockefeller Plaza, Suite 1204, New York NY, 10020, U.S.A. (“River Vision”). 

WHEREAS, River Vision and Roche wish to amend the agreement as follows: 

 

	I.	 The table “II. Material” in Process, Manufacturing Know how on page 61 of Appendix 3 shall be amended
by the addition of the following after the existing table under the titles 

 [***] 

 
  
  

	II.	 Capitalized terms shall have the same meaning as defined in the Agreement. 

 

	III.	 Except as expressly stated herein, no other changes are made to the Agreement and all other terms and
conditions of the Agreement remain in full force and effect. 

  

	IV.	 This Amendment enters into effect on the Effective Date. 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT
BLANK.] 

  
 ***Certain Confidential
Information Omitted 

 IN WITNESS WHEREOF, the parties have
executed this AMENDMENT NO. 4 TO THE AGREEMENT as of the date first above written. 

 

									
	F. HOFFMANN-LA ROCHE LTD	  	        	  		  	
					
	By:	  	 /s/ Vikas Kabra
	  		  	By:	  	 /s/ Melanie Frey Wick

	Name:	  	Vikas Kabra	  		  	Name:	  	Dr. Melanie Frey Wick
	Title:	  	Head of Transaction Excellence	  		  	Title:	  	Legal Counsel
			
	Date:                                 	  		  	Date: July 16, 2014
			
	HOFFMANN-LA ROCHE INC.	  		  	RIVER VISION DEVELOPMENT CORP.
					
	By:	  	 /s/ John P. Parise
	  		  	By:	  	 /s/ D Madden

	Name:	  	John P. Parise	  		  	Name:	  	D Madden
	Title:	  	Authorized Signatory	  		  	Title:	  	CEO
			
	Date:                                 	  		  	Date: Oct/18/13

  

			
	Apprv’d As To Form LAW DEPT.
		
	By	 	 /s/ GB

 Amendment No 5 to License Agreement 

THIS AMENDMENT No 5. to License Agreement (“Amendment”) is entered into as of the 11th of November 2013
(“Effective Date”) by and among: 
 F. HOFFMANN-LA ROCHE
LTD, a corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland
(“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office at 340 Kingsland Street, Nutley,
New Jersey 07110, U.S.A. (“Roche Nutley”; Roche Basel and Roche Nutley together referred to as “Roche”) 

and 
 RIVER
VISION LLC, a limited liability company organized and existing under the laws of Delaware, with its principal office at One Rockefeller Plaza, New York NY, 10020, U.S.A. (“River
Vision”). 
 WHEREAS, River Vision and Roche wish to amend the agreement to as
follows: 
  

	I.	 The table “II. Material” in Process, Manufacturing Know how on page 61 of Appendix 3 was
amended in Amendment No. 2 and Amendment No. 4 with lines as follows: 

 Amendment No. 2 

[***] 
 Amendment No. 4 

[***] 
 Remarks of the Amendments
No. 2 and No. 4 for the test material as mentioned above will be completely replaced by the following remark: 
  

  
 ***Certain Confidential
Information Omitted 

 [***] 
  

	II.	 Capitalized terms shall have the same meaning as defined in the Agreement. 

 

	III.	 Except as expressly stated herein, no other changes are made to the Agreement and all other terms and
conditions of the Agreement remain in full force and effect. 

  

	IV.	 This Amendment enters into effect on the Effective Date. 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT
BLANK.] 
  

  
 ***Certain Confidential
Information Omitted 

 IN WITNESS WHEREOF, the parties have
executed this AMENDMENT NO. 1 TO THE LICENSE AGREEMENT as of the date first above written. 

 

									
	F. HOFFMANN-LA ROCHE LTD	  	        	  		  	
					
	By:	  	 /s/ Christophe Carissimo
	  		  	By:	  	 /s/ Dr. Melanie Frey Wiek

	Name:	  	Christophe Carissimo	  		  	Name:	  	Dr. Melanie Frey Wiek
	Title:	  	Global Head Transaction Excellence	  		  	Title:	  	Legal Counsel
			
	Date: Nov 14, 2013	  		  	Date: November 14, 2013
			
	HOFFMANN-LA ROCHE INC.	  		  	RIVER VISION LLC
					
	By:	  	 /s/ John Parise
	  		  	By:	  	 /s/ D. Madden

	Name:	  	John Parise	  		  	Name:	  	D. Madden
	Title:	  	Authorized Signatory	  		  	Title:	  	CEO
			
	Date: November 20, 2013	  		  	Date: 12 November 2013

 Amendment No 6 to License Agreement 

THIS AMENDMENT NO. 6 TO LICENSE AGREEMENT
(“Amendment”) is entered into as of the 18th December 2014 (“Effective Date”) by and among: 

F. HOFFMANN-LA ROCHE LTD, a
corporation organized and existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under the laws of New Jersey, with its principle office and place of business at 150 Clove Road, 8th Floor, Little Falls, New Jersey 07424, U.S.A.
(“Roche Little Fall”; Roche Basel and Roche Little Falls together referred to as “Roche”) 
 and 

RIVER VISION DEVELOPMENT CORP., a limited liability company organized and existing under
the laws of Delaware, with its principal office at One Rockefeller Plaza, New York NY, 10020, U.S.A. (“River Vision”). 

WHEREAS, River Vision and Roche wish to amend the agreement as follows: 

 

	I.	 The table “II. Material” in Process, Manufacturing Know how on page 61 of Appendix 3 shall be amended
by the addition of the following after the existing table 

 [***] 

  
 ***Certain Confidential
Information Omitted 

	II.	 Capitalized terms shall have the same meaning as defined in the Agreement. 

 

	III.	 Except as expressly stated herein, no other changes are made to the Agreement and all other terms and
conditions of the Agreement remain in full force and effect. 

  

	IV.	 This Amendment enters into effect on the Effective Date. 

[REMAINDER OF THIS PAGE INTENTIONALLY LEFT
BLANK.] 

 IN WITNESS WHEREOF, the parties have
executed this AMENDMENT NO. 6 TO THE AGREEMENT as of the date first above written. 

 

									
	F. HOFFMANN-LA ROCHE LTD	  	        	  		  	
					
	By:	  	 /s/ Timothy Steven
	  		  	By:	  	 /s/ Melanie Frey Wick

	Name:	  	Timothy Steven	  		  	Name:	  	Dr. Melanie Frey Wick
	Title:	  	Global Alliance Director	  		  	Title:	  	Legal Counsel
			
	Date: 8th Jan 2015	  		  	Date: 8th January 2015
			
	HOFFMANN-LA ROCHE INC.	  		  	RIVER VISION DEVELOPMENT CORP.
					
	By:	  	 /s/ John P. Parise
	  		  	By:	  	 /s/ D Madden

	Name:	  	John P. Parise	  		  	Name:	  	D Madden
	Title:	  	Authorized Signatory	  		  	Title:	  	CEO
			
	Date: Jan 13, 2015	  		  	Date: 12/17/14

  

			
	Apprv’d As To Form LAW DEPT.
		
	By	 	 /s/

 Amendment No. 7 to the License Agreement 

This Amendment No. 7 to the License Agreement (“Amendment”) is entered into as of the 24th
of June 2015 (“Effective Date”) by and among: 
 F. Hoffmann-La Roche Ltd., a corporation organized and
existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche
Inc., a corporation organized and existing under the laws of the State of New Jersey, with its principal office and place of business at 150 Clove Road, 8th Floor, Little Falls, NJ 07424, USA
(“Roche Little Falls”; Roche Little Falls and Roche Basel together referred to as “Roche”). 
 And 

River Vision Development Corp, a corporation organized and existing under the laws of Delaware, with its principal office at One Rockefeller Plaza, Suite
1204, New York, NY 10020, USA (“River Vision”). 
 Whereas, Roche and River Vision wish to amend the agreement as follows: 

I. The Table (II. Material in Process, Manufacturing Know-How on page 61 of Appendix 3 shall be amended as follows:

 [***] 
 II. Capitalized
terms used herein shall have the same meaning as defined in the Agreement. 

  
 ***Certain Confidential
Information Omitted 

 III. Except as previously stated herein, no other changes are made to the Agreement and all other terms and
conditions of the Agreement remain in effect. 
 IV. This Amendment enters into effect on the Effective Date. 

In witness whereof, the parties have executed this Amendment No. 7 to the Agreement as of the date first above written. 

F. Hoffmann-La Roche Ltd 
  

									
	By:	  	 /s/ Tim Steven
	  		  	By:	  	 /s/ Melanie Frey Wick

	Name:	  	Tim Steven	  	                	  	Name:	  	Dr. Melanie Frey Wick
	Title:	  	Alliance Director	  		  	Title:	  	  

			
	Date: 21st July 2015	  		  	Date:
                                    
			
	Hoffmann-La Roche Inc.	  		  	River Vision Development Corp.
					
	By:	  	 /s/ David P. McDede
	  		  	By:	  	 /s/ D Madden

	Name:	  	David P. McDede	  		  	Name:	  	D Madden
	Title:	  	VP Treasurer	  		  	Title:	  	CEO
			
	Date: 21 July 2015	  		  	Date: 6/26/15

  

	
	Apprv’d As To Form LAW DEPT.
	
	By /s/ MM                                   
                                         
            

 Amendment No. 8 to the License Agreement 

This Amendment No. 8 to the License Agreement (“Amendment”) is entered into as of the 13th
of November 2015 (“Effective Date”) by and among: 
 F. Hoffmann-La Roche Ltd., a corporation organized and
existing under the laws of Switzerland, with its principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche
Inc., a corporation organized and existing under the laws of the State of New Jersey, with its principal office and place of business at 150 Clove Road, 8th Floor, Little Falls, NJ 07424, USA
(“Roche Little Falls”; Roche Little Falls and Roche Basel together referred to as “Roche”). 
 And 

River Vision Development Corp, a corporation organized and existing under the laws of Delaware, with its principal office at One Rockefeller Plaza, Suite
1204, New York, NY 10020, USA (“River Vision”). 
 Whereas, Roche and River Vision wish to amend the agreement as follows: 

I. The Table (II. Material in Process, Manufacturing Know-How on page 61 of Appendix 3 shall be amended as follows:

 [***] 
 II. Capitalized
terms used herein shall have the same meaning as defined in the Agreement. 
 III. Except as previously stated herein, no other changes to the Agreement and
all other terms and conditions of the Agreement remain in effect. 

  
 ***Certain Confidential
Information Omitted 

 IV. This Amendment enters into effect on the Effective Date. 

In witness whereof, the parties have executed this Amendment No. 8 to the Agreement as of the date first above written. 

 

									
	F. Hoffmann-La Roche Ltd	 		  		  	
					
	By:	 	              
	 		  	By:	  	
                   

	Name:	 	              
	 		  	Name:	  	  

	Title:	 	  
	 		  	Title:	  	  

				
	Date:                                   
  	 	                	  		  	
			
	Hoffmann-La Roche Inc.	 		  	River Vision Development Corp.
					
	By:	 	              
	 		  	By:	  	  

	Name:	 	  
	 		  	Name:	  	  

	Title:	 	  
	 		  	Title:	  	  

			
	Date:                                   
  	 		  	Date:                                   
  

 Amendment No. 9 to the License Agreement 

This Amendment No. 9 to the License Agreement (“Amendment”) is entered into as of the 21st of October, 2016 (“Effective Date”) by and
among 
 F. Hoffmann-La Roche Ltd, a corporation organized and existing under the laws of Switzerland, with its
principal office at Grenzacherstrasse 124, CH-4070 Basel, Switzerland (“Roche Basel”) and Hoffmann-La Roche Inc., a corporation organized and existing under
the laws of the State of New Jersey, with its principal office and place of business at 150 Clove Road, Suite 8, Little Falls, NJ 07424, USA (“Roche Little Falls”; Roche Little Falls and Roche Basel together referred to as
“Roche”). 
 And 
 River Vision Development Corp, a
corporation organized and existing under the laws of Delaware, with its principal office at One Rockefeller Plaza, Suite 1204, New York, NY 10020, USA (“River Vision”). 

WHEREAS, Roche and River Vision wish to amend the agreement as follows: 

I. Section 11.6 shall be deleted and replaces by the following 

“11.6 Infringement by Third Parties. 
 (a) Infringement. Each
party shall promptly provide written notice to the other party during the Term of any known infringement or suspected infringement by a Third Party of any Roche Patents, River Vision Patents (if any) or Joint Patents (if any), or of any invalidity
or unenforceability assertion or challenge to any such patents, or of any unauthorized use or misappropriation of Roche Know-How, and shall provide the other party with all evidence in its possession
supporting such infringement, assertion or challenge or unauthorized use or misappropriation. For clarity, any challenge amounting to a reexamination, interference or opposition will be addressed by Sections 11.2 through 11.5. 

(b) Defense and Enforcement. Within a period of [***] days (“Decision Period”) after either party (i) provides or receives such written notice
with respect to its Patents and (ii) such notice relates to the (a) Compound and/or Product in the Field or (b) an IGF-1R antibody of a third party in the Field (“Affected Patents”),
the party that has the first right to enforce any such Affected Patents as set forth on Schedule 11.6(b) (the “First Party”) that are allegedly infringed, in its sole discretion, shall decide whether or not to initiate a suit or take other
appropriate action with respect to any allegedly infringing activities in the Field (including without limitation defending any assertion or challenge) and shall notify the other party in writing of its decision in writing (“Suit Notice”).

  
 ***Certain Confidential
Information Omitted 
  
 68 

 If the First Party for its Affected Patents are allegedly infringed decides to bring a suit or take action
with respect to any allegedly infringing activities in the Field and provides a respective Suit Notice, then such party may immediately commence such suit or take such action. If such party (i) does not in writing advise the other party within
the Decision Period that it will commence suit or take action, or (ii) fails to commence suit or take action within a reasonable time after providing Suit Notice, then the other party shall thereafter have the right to commence suit or take
action with respect to any allegedly infringing activities in the Field and shall provide written notice to the party whose Affected Patents are allegedly infringed of any such suit commenced or action taken by the other party. 

Upon written request, the party bringing suit or taking action (“Initiating Party”) shall keep the other party informed of the status of any such
suit or action and shall provide the other party with copies of all substantive documents and communications filed in such suit or action. The Initiating Party shall have the sole and exclusive right to control any such suit or action, including but
not limited to selecting counsel for any such suit or action. If each of the parties elects to be an Initiating Party with respect to the same allegedly infringing activities within the Field, then the parties shall meet and agree on how to manage
the resulting suits and actions (including with respect to the process set forth in Section 11.7). If River Vision is the Initiating Party with respect to the Compound Patent, upon Roche request, River Vision and Roche shall jointly agree in
good faith on the strategy on how to bring suit or take action with respect to such Compound Patent, such discussions to be held in good faith, and failure to agree shall not jeopardize timing regarding any such suit or action. 

The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including, without limitation, the Initiating Party’s
attorneys’ fees, damages and court costs. If the Initiating Party believes it reasonably necessary, upon written request the other party shall join as a party to the suit or action, but shall be under no obligation to participate, except to the
extent that such participation is required as the result of its being a named party to the suit or action. Alternatively, at the Initiating Party’s request, the other party will bring the suit or action in the other party’s name, if the
Initiating Party reasonably believes that the Initiating Party does not have standing to bring the suit or action, and in such event, the Initiating Party will still control the suit or action as provided above. At the Initiating Party’s
written request, the other party shall offer reasonable assistance to the Initiating Party in connection therewith at no charge to the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other party in rendering such assistance. The other party shall have the right to participate and be represented in any such suit or action by its own counsel at its own
expense. 
 The Initiating Party shall not settle, agree to a consent judgment or otherwise voluntarily dispose of the suit or action without the written
consent of the other party, which consent shall not be unreasonably withheld or delayed; provided that if River Vision is the Initiating Party, any such consent from Roche is not required if River Vision grants a permitted sub-license under Sections 2.5 and 3. 
 Except as otherwise agreed by the parties in connection with a cost-sharing
arrangement, any recovery realized as a result of litigation described in this Section 11.6 (whether by way of settlement or otherwise) will be first allocated to reimbursement of unreimbursed legal fees and expenses incurred by the Initiating
Party(ies), then toward reimbursement of any unreimbursed legal fees and expenses of the other party if not an Initiating Party, and then the remainder will be shared between the parties by allocating (i) [***]% to River Vision

  
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and [***] to Roche for those Affected Patents infringed where River Vision is the Initiating Party, (ii) [***]% to Roche and [***] to Roche for those Affected Patents infringed where Roche is the
Initiating Party, and (iii) if there are Affected Patents infringed for which River Vision is the Initiating Party for one or more of those Affected Patents and Roche is the Initiating Party for one or more of those Patents[***]. 

(c) Exclusion. For clarity, this Section 11.6 shall not apply to the [***] Agreement, the [***] Agreement and the [***] Agreement. 

II. Appendix 1 of the Agreement shall be deleted and replaced by Appendix 1 attached to this Amendment No 9. 

III. Appendix 2 of the Agreement shall be deleted and replaced by Appendix 2 attached to this Amendment No. 9. 

IV.In case the validity of any patent family member of the Roche Patents summarized under [***] in Appendix 2 is challenged by a Third Party, Roche shall have
the right to decide at its own discretion how to defend such patent family member or about further steps to be taken with respect to (including the decision to abandon) such patent family member of the Roche Patents summarized under [***]. Roche
shall inform River Vision accordingly. 
 V. Capitalized terms used herein shall have the same meaning as defined in the Agreement. 

VI. Except as previously stated herein, no other changes to the Agreement and all other terms and conditions of the Agreement remain in effect. 

VII. This Amendment No. 9 enters into effect on the Effective Date. 

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 120 

 In witness whereof, the parties have executed this Amendment No. 9 to the Agreement as of the date
first above written. 
  

									
	F. Hoffmann-La Roche Ltd	  		  		  	
					
	By:	  	 /s/ Timothy Steven
	  		  	By:	  	 /s/ Melanie Wick

	Name:	  	Timothy Steven	  		  	Name:	  	Melanie Wick
	Title:	  	Global Alliance Director	  	                	  	Title:	  	Legal Counsel
				
	Date: 9th May 2017	  		  		  	
			
	Hoffmann-La Roche Inc.	  		  	River Vision Development Corp.
					
	By:	  	 /s/ John Parise
	  		  	By:	  	 /s/ D Madden

	Name:	  	John Parise	  		  	Name:	  	D Madden
	Title:	  	Assistant Secretary	  		  	Title:	  	CEO
			
	Date: May 9, 2017	  		  	Date: May / 5 / 2017

  
 121 

 Appendix 1 

Compound 
 teprotumumab is a human IgG1
antibody binding to IGFIR [***] 
  

  
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 1 

 Appendix 2 

Roche Patents 
 [***] 

  
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 2 

	
	[***]

  

  
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 [***] 

  
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 [***] 

  
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 5 

 [***] 
  

 
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intentionally left blank.] 

  
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 [***] 

  
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 [***] 

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