Document:

First Amendment to Agreement for the Provision of a Loan Facility

 Exhibit 10.7 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 

Confidential Treatment Requested 

Under 17 C.F.R. Sections 200.80(b)(4) 

and 230.406. 
 FIRST
AMENDMENT TO AGREEMENT FOR THE PROVISION 
 OF A LOAN FACILITY OF UP TO EURO 7,500,000 

This First Amendment To Agreement For The Provision Of A Loan Facility Of Up To Euro 7,500,000
(“Amendment”) is made and entered into as of April 1, 2010, by and between Nitec Pharma AG, a company incorporated in Switzerland with number CH-280.3.007.771-0/ (“Borrower”), and
Kreos Capital III (UK) Limited, a company incorporated in England and Wales whose company number is 05981165 (“Lender”). 

Recitals 
 A.
Borrower and Lender have entered into that certain Agreement for the Provision of a Loan Facility of up to Euro 7,500,000 dated August 15, 2008 (the “Loan Agreement”) pursuant to which Lender has agreed to extend and
make available to Borrower certain advances of money. 
 B. Borrower desires that Lender amend the Loan Agreement and the
Security Documents (as defined therein) upon the terms and conditions more fully set forth herein. 
 C. Subject to the
representations and warranties of Borrower herein and upon the terms and conditions set forth in this Amendment, Lender is willing to so amend the Loan Agreement and the Security Documents. 

Agreement 
 Now,
Therefore, in consideration of the foregoing recitals and the mutual covenants herein set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound,
Borrower and Lender hereby agree to amend the Loan Agreement and the Security Documents as follows: 
  

	1.	Definitions. Unless otherwise defined herein, all terms defined in the Loan Agreement have the same meaning when used herein. 

 

	2.	Consent to Acquisition of Borrower by Horizon Pharma, Inc. Lender hereby consents to the transactions contemplated under that Share Exchange Agreement dated on
or about the date hereof by and among Borrower, Horizon Therapeutics, Inc., a Delaware corporation, Horizon Pharma, Inc., the shareholders of Borrower, certain stockholders of Horizon Therapeutics, Inc., and a representative of the stockholders of
Horizon Therapeutics, Inc. pursuant to which immediately following the consummation of such transactions, the existing stockholders of Horizon Therapeutics, Inc. will own approximately 51% of Horizon Pharma, Inc. on a fully-diluted basis and the
existing shareholders of Borrower will own approximately 49% of Horizon Pharma, Inc. on a fully-diluted basis, and Horizon Pharma, Inc. will own 100% of the capital stock of Horizon Therapeutics, Inc. and 100% of the capital stock of Borrower.
Lender further acknowledges and agrees that such transaction is permitted notwithstanding that it constitutes a “change of control” as defined in Clause 9.1.12 of the Loan Agreement. Without limiting the foregoing, Lender agrees that the
completion of such transaction shall not constitute an Event of Default under the Loan Agreement or give rise to the consequences set forth in Clauses 9.2.1 and 9.2.2 of the Loan Agreement. 

 

	3.	Amendments to Loan Agreement. 

 3.1 Clause 3.7.3 of the Loan Agreement is hereby amended and restated
in its entirety to read as follows: 
 “Upon the loan being discharged in full and the Lender under no further obligation to make any
financial accommodation or loan facility to the Borrower under this Loan Agreement or upon the closing of a firmly underwritten public offering pursuant to an effective registration statement under the United States Securities Act of 1933, as
amended, covering the offer and sale of common stock of the holding company of the Borrower, for at least [...***...] before deducting underwriting discounts and commissions and other offering expenses (the “Qualified IPO”), the
Pledged Assets (as defined in the Pledge Agreement) shall be released to the Borrower or such other Party as designated by the Borrower.” 

3.2 Clause 5.2 of the Loan Agreement is hereby amended and restated in its entirety to read as follows: 

“The Borrower shall pay accrued interest only on the outstanding principal balance of the Loan on the first Business Day of each calendar month
amounting to €50,000 per calendar month, commencing on May 1, 2010 and ending on December 1, 2010. Thereafter, the Borrower shall repay the outstanding principal balance of the Loan in 35 equal monthly payments of principal, each
such payment in the amount shown on Schedule 5.2 attached hereto at Exhibit A, together with accrued and unpaid interest thereon, amounting to €184,000 per month to be paid to the Lender on the first Business Day of the 35 calendar
months, commencing on January 1, 2011. Any amount repaid or prepaid may not be redrawn.” 
 3.3
Clause 7.1.12 of the Loan Agreement is hereby amended by deleting the phrase “and each date of repayment” contained therein. 

3.4 Clause 8.1.6 of the Loan Agreement is amended (i) by deleting “Company” in the eighth line
thereof and substituting “Borrower” therefor and (ii) by deleting “proposed to be” in the fourteenth line thereof. 

3.5 Clause 8.1.7 of the Loan Agreement is amended by deleting “each Group Company” in the third line
thereof and substituting “its parent holding company on a consolidated basis” therefor. 
 3.6
Clause 8.1.9 of the Loan Agreement is amended by adding the following language to the end thereof: 
 “subject to exclusion of access
to proprietary information, confidential information relating to employees (including compensation), and other information as reasonably necessary to preserve the attorney-client privilege.” 

3.7 Clause 8.1.11 of the Loan Agreement is amended by deleting the second sentence thereof that begins “In
addition, upon the occurrence of a default...” and substituting the following therefor: 
 “In addition, upon the occurrence of an
Event of Default and during the continuance thereof, the Lender shall be entitled to have a representative to attend all meetings of the Borrower’s board of directors in a non-voting observer capacity, subject to exclusion of access to
proprietary information, confidential information relating to employees (including compensation), and other information as reasonably necessary to preserve the attorney-client privilege.” 

***Confidential Treatment Requested 
  

 2 

 3.8 Clause 8.1.15 of the Loan Agreement is hereby amended (i) by
deleting “or” at the end of clause 8.1.15.2 and (ii) by adding the following new clauses 8.1.15.4 and 8.1.15.5 to read as follows: 

“8.1.15.4 under the Loan and Security Agreement dated as of April 1, 2010 by and among Horizon Pharma, Inc., Lender, and Silicon Valley
Bank, as the same may be amended or amended and restated from time to time; or 
 8.1.15.5 those certain subordinated convertible
promissory notes, in an aggregate principal amount of up to US $10,000,000 (the “Subordinated Notes”), as may be issued by Horizon Pharma, Inc. from time to time pursuant to the terms of that certain Series B Preferred Stock and
Subordinated Convertible Note Purchase Agreement dated on or about April 1, 2010 by and among Horizon Pharma, Inc. and the Purchasers listed on the Schedule of Purchasers thereto (the “Purchase Agreement”), as the Subordinated Notes
and Purchase Agreement may be amended from time to time;” 
 3.9 Clause 8.1.19 of the Loan
Agreement is hereby amended and restated in its entirety to read as follows: 
 “8.1.19 Clauses 8.1.3, 8.1.4, 8.1.17 and 8.1.18 do
not apply to: 
 8.1.19.1 Security provided to the Lender under the Loan Agreement or any Security Document; 

8.1.19.2 Security provided to Lender and Silicon Valley Bank under the Loan and Security Agreement referred to in clause 8.1.15.4; 

8.1.19.3 any netting or set-off arrangement entered into by any Group Company in the ordinary course of its banking arrangements for the purpose of
netting debit and credit balances; 
 8.1.19.4 any lien arising by operation of law and in the ordinary course of trading, including liens of
carriers, warehousemen, suppliers, or other persons that are possessory in nature and liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations; 

8.1.19.5 any lien for taxes, fees, assessments or other government charges or levies, either not due and payable or being contested in good faith and for
which the Borrower or other Group Company (as the case may be) maintains adequate reserves on its books; provided that no notice of any such lien has been filed or recorded by any government authority; and 

8.1.19.6 liens arising solely by virtue of any statutory or common law provision relating to banker’s liens, rights of setoff or similar rights and
remedies as to deposit accounts or other funds maintained with a creditor depository institution; 
 8.1.19.7 Clauses 8.1.3, 8.1.4, 8.1.17,
8.1.18, and 8.1.22 do not apply to non-exclusive or exclusive licenses granted by the Borrower or any Group Company to Borrower or a Group Company or a third party over any of its Intellectual Property rights provided that (i) such licenses are
granted for full market value and (ii) such licenses are granted in arms’ length transactions in the ordinary course of business for the development, manufacture, marketing, distribution and/or commercialization of DUEXA and/or LODOTRA. In
addition, clauses 8.1.3, 8.1.4, 8.1.17, 8.1.18, and 8.1.22, insofar as they apply to the Pledged Assets (as such term is defined in the Pledge Agreement), shall no longer have any force and effect, and shall be deemed to be automatically deleted
from this Loan Agreement, upon the later of the completion by the holding company of the 
  

 3 

 
Borrower of a Qualified IPO or the issuance by the FDA of marketing approval for either DUEXA or LODOTRA. 

3.10 Clause 9.1.12 of the Loan Agreement is hereby amended (i) until the later of the completion by the
holding company of the Borrower of a Qualified IPO or the issuance by the FDA of marketing approval for either DUEXA or LODOTRA, by inserting the phrase “except for exclusive licenses permitted by the first sentence of clause 8.1.19.7”
immediately before the words “the exclusive license” in the thirteenth line thereof and (ii) upon the later of the completion by the holding company of the Borrower of a Qualified IPO or the issuance by the FDA of marketing approval
for either DUEXA or LODOTRA, by deleting the phrase “or the exclusive license of all or a material portion of the Borrower’s intellectual property, to any other entity or person, other than a wholly-owned subsidiary of the Borrower”.

  

	4.	Amendment to Pledge Agreement. 

4.1 Clause 3.2 of the Pledge Agreement is hereby amended by adding the following language to the end thereof:

 “or such licenses are granted in arms’ length transactions in the ordinary course of business for the development, manufacture,
marketing, distribution and/or commercialization of DUEXA and/or LODOTRA. In addition, this clause 3.2 shall no longer have any force and effect, and shall be deemed to be automatically deleted from this Agreement, upon the later of the completion
by the holding company of the Borrower of a Qualified IPO or the issuance by the FDA of marketing approval for either DUEXA or LODOTRA” 

4.2 Clause 3.3 of the Pledge Agreement is hereby amended by adding the following language to the end thereof:

 “or such licenses are granted in arms’ length transactions in the ordinary course of business for the development, manufacture,
marketing, distribution and/or commercialization of DUEXA and/or LODOTRA. In addition, this clause 3.3 shall no longer have any force and effect, and shall be deemed to be automatically deleted from this Agreement, upon the later of the completion
by the holding company of the Borrower of a Qualified IPO or the issuance by the FDA of marketing approval for either DUEXA or LODOTRA” 

4.3 Clause 5.1 of the Pledge Agreement is hereby amended and restated in its entirety to read as follows:

 “Upon the Secured Liabilities being discharged in full and the Pledgee being under no further actual or contingent obligation to make
any financial accommodation or loan facility to the Pledgor under the Loan Agreement, or upon the closing of a firmly underwritten public offering pursuant to an effective registration statement under the United States Securities Act of 1933, as
amended, covering the offer and sale of common stock of the holding company of the Pledgor, for at least [...***...] before deducting underwriting discounts and commissions and other offering expenses, the Pledged Assets or any
remainder thereof shall be released at the request of the Pledgor, to the Pledgor or such other party as designated by the Pledgor.” 
  

	5.	Amendment to Receivables Assignment Agreement. 

5.1 Clause 5.1 of the Receivables Assignment Agreement is hereby amended and restated in its entirety to read as
follows: 
 ***Confidential Treatment Requested 

 

 4 

 “Upon the Secured Liabilities being discharged in full and the Assignee being under no further
obligation to make any financial accommodation or loan facility to the Assignor under the Loan Agreement, the assigned Receivables shall be released and re-assigned at the request of the Assignor, to the Assignor or such other party as designated by
the Assignor.” 
  

	6.	Ratification and Reaffirmation of Liens. Borrower hereby ratifies and reaffirms the validity and enforceability of all of the liens and security interests
heretofore granted pursuant to the Security Documents, as collateral security for the Secured Liabilities (as defined therein), and acknowledges that all of such liens and security interests, and all Charged Assets heretofore pledged as security for
the Secured Liabilities continue to be and remain subject to the Security Documents from and after the date hereof until released as provided in the Loan Agreement and the Security Documents. 

 

	7.	Representations And Warranties. Borrower represents and warrants that its representations and warranties in the Loan Agreement and the Security Documents
continue to be true and complete in all material respects as of the date hereof after giving effect to this Amendment and that the execution, delivery and performance of this Amendment are duly authorized, do not require the consent or approval of
any governmental body or regulatory authority and are not in contravention of or in conflict with any law or regulation or any term or provision of any other agreement entered into by Borrower. 

 

	8.	Full Force And Effect; Entire Agreement. Except to the extent expressly provided in this Amendment, the terms and conditions of the Loan Agreement and the
Security Documents shall remain in full force and effect. This Amendment, the Security Documents, and the Option Agreement among Borrower, Lender, and Kreos Capital III Limited executed on or about September 9, 2008 constitute and contain the
entire agreement of the parties hereto and supersede any and all prior agreements, negotiations, correspondence, understandings and communications between the parties, whether written or oral, respecting the subject matter hereof. The parties hereto
further agree that the Loan Agreement, the Security Documents, and said Option Agreement comprise the entire agreement of the parties thereto and supersede any and all prior agreements, negotiations, correspondence, understandings and other
communications between the parties thereto, whether written or oral respecting the extension of credit by Lender to Borrower. 

  

	9.	Counterparts; Effectiveness. This Amendment may be executed in any number of counterparts, each of which when so delivered shall be deemed an original, but all
such counterparts taken together shall constitute but one and the same instrument. This Amendment shall be deemed effective as of the date first written above 

 

	10.	 Option Agreement and Warrant. In consideration of this Amendment and in connection with the acquisition of the Borrower referenced in
Section 2 of this Amendment (the “Acquisition”), Borrower, Lender and Kreos Capital III Limited agree that certain Option Agreement dated September 10, 2008 issued by Borrower to Lender and Kreos Capital III Limited (as may have
been amended from time to time, the “Existing Option”) shall, as of the date of this Amendment, 

  

 5 

	 	 
be exchanged for a warrant to purchase Series A Preferred Stock of Horizon Pharma, Inc., the parent of Borrower, in the form attached hereto as Exhibit B (the “Warrant”). Upon the
execution and delivery of the Warrant to Lender and to Kreos Capital III Limited, the Existing Option shall be deemed cancelled and terminated effective as of the closing of the Acquisition. Each of Lender and Kreos Capital III Limited hereby waives
any right to notice it may have under the Existing Option with respect to the Acquisition and each of Lender and Kreos Capital III Limited hereby releases and forever discharges Borrower, its parent, subsidiaries, affiliates and agents from any and
all claims, demands, liabilities and obligations of any kind, known or unknown, arising under or related to the Existing Option. 

11. Governing Law. This Amendment shall be governed by the laws of England and the parties accept the non-exclusive jurisdiction of the courts of
England 
 [signature page to follow] 
  

 6 

 IN WITNESS WHEREOF, each
of the parties hereto has caused this Amendment to be executed and delivered by its duly authorized officer as of the date first written above. 
  

			
	BORROWER:
	
	NITEC PHARMA AG
		
	By:	 	 /s/ Anders Härfstrand

			
	Name:	 	Anders Härfstrand
	Title:	 	CEO                            
EVP
	
	LENDER:
	
	KREOS CAPITAL III (UK) LIMITED

			
		
	By:	 	  

			
	Name:
	Title:
	
	(solely for purposes of Clause 10 of the Amendment:)
	
	KREOS CAPITAL III LIMITED
		
	By:	 	  

			
	Name:	 	
	Title:	 	

 IN WITNESS WHEREOF, each
of the parties hereto has caused this Amendment to be executed and delivered by its duly authorized officer as of the date first written above. 
  

			
	BORROWER:
	
	NITEC PHARMA AG
		
	By:	 	  

			
	Name:	 	
	Title:	 	
	
	LENDER:
	
	KREOS CAPITAL III (UK) LIMITED

			
		
	By:	 	 /s/ Maurizio Petit Bon

			
	Name:	 	 Maurizio Petit Bon

	Title:	 	Director
	
	(solely for purposes of Clause 10 of the Amendment:)
	
	KREOS CAPITAL III LIMITED

			
		
	By:	 	  

			
	Name:	 	
	Title:	 	

 IN WITNESS WHEREOF, each
of the parties hereto has caused this Amendment to be executed and delivered by its duly authorized officer as of the date first written above. 
  

			
	BORROWER:
	
	NITEC PHARMA AG

			
		
	By:	 	  

			
	Name:	 	
	Title:	 	
	
	LENDER:
	
	KREOS CAPITAL III (UK) LIMITED

			
		
	By:	 	  

			
	Name:	 	
	Title:	 	
	
	(solely for purposes of Clause 10 of the Amendment:)
	
	KREOS CAPITAL III LIMITED

			
		
	By:	 	 /s/ Ross Ahlgren

			
	Name:	 	 Ross Ahlgren

	Title:	 	

 EXHIBIT A 

SCHEDULE 5.2 
 All amounts stated are
in Euros 
  

			
	 Due Date
	  	Repayment
Amount
	 01-May-10
	  	50,000.00
	 01-Jun-10
	  	50,000.00
	 01-Jul-10
	  	50,000.00
	 01-Aug-10
	  	50,000.00
	 01-Sep-10
	  	50,000.00
	 01-Oct-10
	  	50,000.00
	 01-Nov-10
	  	50,000.00
	 01-Dec-10
	  	50,000.00
	 01-Jan-11
	  	184,000.00
	 01-Feb-11
	  	184,000.00
	 01-Mar-11
	  	184,000.00
	 01-Apr-11
	  	184,000.00
	 01-May-11
	  	184,000.00
	 01-Jun-11
	  	184,000.00
	 01-Jul-11
	  	184,000.00
	 01-Aug-11
	  	184,000.00
	 01-Sep-11
	  	184,000.00
	 01-Oct-11
	  	184,000.00
	 01-Nov-11
	  	184,000.00

  

 10 

			
	 01-Dec-11
	  	184,000.00
	 01-Jan-12
	  	184,000.00
	 01-Feb-12
	  	184,000.00
	 01-Mar-12
	  	184,000.00
	 01-Apr-12
	  	184,000.00
	 01-May-12
	  	184,000.00
	 01-Jun-12
	  	184,000.00
	 01-Jul-12
	  	184,000.00
	 01-Aug-12
	  	184,000.00
	 01-Sep-12
	  	184,000.00
	 01-Oct-12
	  	184,000.00
	 01-Nov-12
	  	184,000.00
	 01-Dec-12
	  	184,000.00
	 01-Jan-13
	  	184,000.00
	 01-Feb-13
	  	184,000.00
	 01-Mar-13
	  	184,000.00
	 01-Apr-13
	  	184,000.00
	 01-May-13
	  	184,000.00
	 01-Jun-13
	  	184,000.00
	 01-Jul-13
	  	184,000.00
	 01-Aug-13
	  	184,000.00
	 01-Sep-13
	  	184,000.00
	 01-Oct-13
	  	184,000.00

  

 11 

			
	 01-Nov-13
	  	184,000.00

  

 12 

 EXHIBIT B 

FORM OF WARRANT AGREEMENT 
  

 13 

 THE SECURITIES REPRESENTED HEREBY HAVE BEEN ACQUIRED PURSUANT TO REGULATION S OF THE SECURITIES ACT OF
1933, AS AMENDED (THE “ACT”), AND MAY NOT BE SOLD, MORTGAGED, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED EXCEPT IN ACCORDANCE THEREWITH, PURSUANT TO A REGISTRATION UNDER THE ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION.
THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT ANY PROPOSED TRANSFER OR RESALE IS IN COMPLIANCE WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS. IN ADDITION,
NO HEDGING TRANSACTION MAY BE CONDUCTED WITH RESPECT TO THESE SECURITIES UNLESS SUCH TRANSACTIONS ARE IN COMPLIANCE WITH THE ACT. 

HORIZON PHARMA, INC. 

WARRANT TO PURCHASE SERIES A PREFERRED STOCK [SERIES A FOR THE 

REPLACEMENT WARRANT; SERIES B FOR THE NEW
KREOS AND SVB WARRANTS UNDER THE 

NEW LOAN] 
  

			
	 No. PAW-    
	 	April     , 2010

Void After April     , 2020 

[NOTE: THIS FORM OF WARRANT IS
INTENDED TO SERVE TWO PURPOSES: (1) TO BE THE REPLACEMENT WARRANT FOR
THE EXISTING KREOS OPTION, FOR WHICH IT WILL BE A SERIES A PREFERRED
WARRANT, AND (2) TO BE THE FORM OF SERIES B WARRANT FOR BOTH KREOS
AND SVB] 
 THIS CERTIFIES THAT, for value
received, Kreos Capital III Limited, with its principal office at 47 Esplanade, St-Helier, Jersey or assigns (the “Holder”), is entitled to subscribe for and purchase at the Exercise Price (defined below) from
HORIZON PHARMA, INC., a Delaware corporation, with its principal office at 1033 Skokie Boulevard, Suite 355, Northbrook, Illinois 60062 (the “Company”) up to
[                     (            )] shares of the Series A
Preferred Stock of the Company (the “Series A Stock”) or if the outstanding Series A Preferred Stock is converted into Common Stock of the Company, then the number of shares of Common Stock of the Company (the
“Common Stock”) into which such Series A Stock would have been converted had the Warrant been exercised immediately prior to the conversion of the outstanding Series A Preferred Stock into Common Stock. 

1. DEFINITIONS. As used herein, the following terms shall have the following respective meanings:

 (a) “Current Market Price” as of a specified date shall mean: (i) if the Warrant is
exercisable for Common Stock and the Common Stock is publicly traded on such date, the average closing price per share over the preceding five trading days (or, if less than five days, the average closing price per share of all trading days since
the stock became publicly traded) as reported on the principal stock exchange or quotation system on which the stock is listed or quoted; or (ii) if the Series A Stock (as adjusted herein) is not publicly traded on such

  

 1. 

 
date, the Board of Directors of the Company shall determine Current Market Price in its reasonable good faith judgment. 

(b) “Exercise Period” means the period commencing with the date hereof and ending on April
    , 2020, unless sooner terminated as provided below. 
 (c) “Exercise
Price” means U.S.$0.01 per share, subject to adjustment pursuant to Section 6 below. If the outstanding Series A Stock converts into Common Stock at a conversion rate that is more or less than one share for one share, then the per
share Exercise Price shall be adjusted by dividing the aggregate Exercise Price of all of the Exercise Shares immediately prior to the conversion by the number of Exercise Shares immediately following the conversion. 

(d) “Exercise Shares” means as applicable the shares of the Series A Stock or shares of Common Stock
issuable upon exercise of this Warrant, subject to adjustment pursuant to the terms herein, including but not limited to adjustment pursuant to Section 6 below. 

(e) “United States” means the United States of America, its territories and possessions, any State
of the United States, and the District of Columbia. 
 (f) “U.S. Person” means (i) any
natural person resident in the United States, (ii) any partnership or corporation organized or incorporated under the laws of the United States (iii) any estate of which any executor or administrator is a U.S. Person, (iv) any trust
of which any trustee is a U.S. Person, (v) any agency or branch of a foreign entity located in the United States, (vi) any non-discretionary account or similar account (other than an estate or trust) held by a dealer or other fiduciary for
the benefit or account of a U.S. Person, (vii) any discretionary account or similar account (other than an estate or trust) held by a dealer or other fiduciary organized, incorporated, or (if an individual) resident in the United States, and
(viii) any partnership or corporation if: (1) organized or incorporated under the laws of any foreign jurisdiction; and (2) formed by a U.S. Person principally for the purpose of investing in securities not registered under the Act
(as defined below), unless it is organized or incorporated, and owned, by accredited investors (as defined in Regulation D under the Act) who are not natural persons, estates or trusts, provided, however, the following are not “U.S.
Persons”: (i) any discretionary account or similar account (other than an estate or trust) held for the benefit or account of a non-U.S. Person by a dealer or other professional fiduciary organized, incorporated, or (if an individual)
resident in the United States, (ii) any estate of which any professional fiduciary acting as executor or administrator is a U.S. Person if: (1) an executor or administrator of the estate who is not a U.S. Person has sole or shared
investment discretion with respect to the assets of the estate; and (2) the estate is governed by foreign law, (iii) any trust of which any professional fiduciary acting as trustee is a U.S. Person, if a trustee who is not a U.S. Person
has sole or shared investment discretion with respect to the trust assets, and no beneficiary of the trust (and no settler if the trust is revocable) is a U.S. Person, (iv) an employee benefit plan established and administered in accordance
with the law of a country other than the United States and customary practices and documentation of such country, (v) any agency or branch of a U.S. Person located outside the United States if: (1) the agency or branch operates for valid
business reasons; and (2) the agency or branch is engaged in the business of insurance or banking and is subject to substantive insurance or banking regulation, respectively, in the jurisdiction where

  

 2. 

 
located; and (vi) the International Monetary Fund, the International Bank for Reconstruction and Development, the Inter-American Development Bank, the Asian Development Bank, the African
Development Bank, the United Nations, and their agencies, affiliates and pension plans, and any other similar international organizations, their agencies, affiliates and pension plans. 

2. EXERCISE OF WARRANT. The rights represented by this Warrant may be exercised in
whole or in part at any time during the Exercise Period, by delivery of the following to the Company at its address set forth above (or at such other address as it may designate by notice in writing to the Holder): 

(a) An executed Notice of Exercise in the form attached hereto; 

(b) Payment of the Exercise Price either (i) in cash or by check, (ii) by cancellation of indebtedness, or (iii) as
provided in Section 2.1; and 
 (c) This Warrant. 

Upon the exercise of the rights represented by this Warrant, a certificate or certificates for the Exercise Shares so purchased,
registered in the name of the Holder or persons affiliated with the Holder, if the Holder so designates, shall be issued and delivered to the Holder within a reasonable time after the rights represented by this Warrant shall have been so exercised.

 The person in whose name any certificate or certificates for Exercise Shares are to be issued upon exercise of this Warrant
shall be deemed to have become the holder of record of such shares on the date on which this Warrant was surrendered and payment of the Exercise Price was made, irrespective of the date of delivery of such certificate or certificates, except that,
if the date of such surrender and payment is a date when the stock transfer books of the Company are closed, such person shall be deemed to have become the holder of such shares at the close of business on the next succeeding date on which the stock
transfer books are open. 
 2.1 Net Exercise. Notwithstanding any provisions herein to the contrary, if the fair market
value of one share of the Series A Stock (or as applicable one share of Common Stock) is greater than the Exercise Price (at the date of calculation as set forth below), in lieu of exercising this Warrant by payment of cash, the Holder may elect to
receive shares equal to the value (as determined below) of this Warrant (or the portion thereof being canceled) by surrender of this Warrant at the principal office of the Company together with the properly endorsed Notice of Exercise in which event
the Company shall issue to the Holder a number of shares of Series A Stock or Common Stock computed using the following formula: 
  

							
		 		 		  	X = Y (A-B)
		 		 		  	          A
				
		 	Where	 	X =	  	the number of shares of Series A Stock to be issued to the Holder
				
		 		 	Y =	  	the number of shares of Series A Stock purchasable under the Warrant or, if only a portion of the Warrant is being exercised, the portion of the Warrant being canceled (at the date
of such calculation)

  

 3. 

							
		 	A	 	=	  	Current Market Price (at the date of such calculation)
				
		 	B	 	=	  	Exercise Price (as adjusted to the date of such calculation)

2.2 Automatic Exercise. Notwithstanding any provisions herein to the contrary, if the Holder of this Warrant has not
elected to exercise this Warrant prior to expiration of this Warrant pursuant to Section 8, then this Warrant shall automatically (without any act on the part of the Holder) be exercised pursuant to Section 2.1 effective immediately prior
to the expiration of the Warrant to the extent such net issue exercise would result in the issuance of Exercise Shares unless Holder shall earlier provide written notice to the Company that the Holder desires that this Warrant expire unexercised. If
this Warrant is automatically exercised, the Company shall notify the Holder of the automatic exercise as soon as reasonably practicable, and the Holder shall surrender the Warrant to the Company in accordance with the terms hereof. 

3. COVENANTS OF THE COMPANY. 

3.1 Covenants as to Exercise Shares. The Company covenants and agrees that all Exercise Shares that may be issued upon the
exercise of the rights represented by this Warrant will, upon issuance, be validly issued and outstanding, fully paid and nonassessable, and free from all taxes, liens and charges with respect to the issuance thereof. The Company further covenants
and agrees that the Company will at all times during the Exercise Period, have authorized and reserved, free from preemptive rights, a sufficient number of shares of its Series A Stock and Common Stock to provide for the exercise of the rights
represented by this Warrant and the conversion of the Series A Stock into Common Stock. If at any time during the Exercise Period the number of authorized but unissued shares of Series A Stock or Common Stock, as applicable, shall not be sufficient
to permit exercise of this Warrant, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Series A Stock or Common Stock to such number of shares as shall be
sufficient for such purposes. 
 3.2 Rights under the Investor Rights Agreement. The Holder shall be entitled to
registration rights with respect to the Exercise Shares, or the Common Stock issuable upon conversion thereof, as set forth in that certain Investors’ Rights Agreement, dated as of April 1, 2010, a true and complete copy of which is
attached hereto as Appendix I (the “Investor Rights Agreement”), as such may from time to time be amended, for purposes of Sections 1 (with the exception of Section 1.2) and 3 only. The Exercise Shares shall also be
deemed “Registrable Securities” as that term is defined in the Investor Rights Agreement, and the Holder shall be deemed a “Holder,” subject to all of the rights and obligations thereunder, in each case only for the purposes of
those sections listed above. The Holder shall perform such steps as are required by the Company to make it a party to the Investor Rights Agreement as described in this Section 3.2. The Company agrees that no amendments will be made to the
Investor Rights Agreement which would have an adverse impact on Holder’s registration rights thereunder different from the impact on the rights of other Holders (as defined in the Rights Agreement) of the Company’s stock without the
consent of Holder. By acceptance of this Warrant, Holder shall be deemed to be a party to the Investor Rights Agreement solely for the purposes of the above-mentioned registration rights. 

 

 4. 

 4. REPRESENTATIONS OF HOLDER.

 4.1 Acquisition of Warrant for Personal Account. 

(a) The Holder represents and warrants that it is acquiring the Warrant and the Exercise Shares solely for its account for
investment, not as a nominee or agent, and not for the account or benefit of, a U.S. Person, and not with a view to or for sale or distribution of said Warrant or Exercise Shares or any part thereof in the United States or to a U.S.
Person. The Holder also represents that the entire legal and beneficial interests of the Warrant and Exercise Shares the Holder is acquiring is being acquired for, and will be held for, its account only. 

(b) The Holder represents and warrants that it does not have any contract, undertaking, agreement or arrangement with any person
to sell, transfer or grant participations to such person or to any third person in the United States or to a U.S. Person, or any hedging transaction with any third person in the United States or to a United States resident, with respect to the
Warrant or any of the Exercise Shares. 
 (c) The Holder is a person or entity that is not a U.S. Person. 

(d) The Holder understands that it could lose its entire investment in the Company. 

4.2 Securities Are Not Registered. 

(a) The Holder understands that the Warrant and the Exercise Shares have not been registered under the Securities Act of 1933, as
amended (the “Act”), on the basis that the issuance of the Warrant and the Exercise Shares are exempt from registration under the Act pursuant to Regulation S thereof. The Holder realizes that the basis for the exemption may not be present
if, notwithstanding its representations, the Holder has a present intention of acquiring the securities for a fixed or determinable period in the future, selling (in connection with a distribution or otherwise), granting any participation in, or
otherwise distributing the securities. The Holder has no such present intention. 
 (b) The Holder recognizes that the
Warrant and the Exercise Shares must be held indefinitely unless they are subsequently registered under the Act in accordance with the provisions of Regulations S, or an exemption from such registration is available. The Holder recognizes that the
Company has no obligation to register the Warrant or the Exercise Shares of the Company, or to comply with any exemption from such registration. 

(c) The Holder is aware that neither the Warrant nor the Exercise Shares may be sold pursuant to Rule 144 adopted under the Act
unless certain conditions are met, including, among other things, the existence of a public market for the shares, the availability of certain current public information about the Company, the resale following the required holding period under Rule
144 and the number of shares being sold during any three month period not exceeding specified limitations. Holder is aware that the conditions for resale set forth in Rule 144 have not been satisfied and that the Company presently has no plans to
satisfy these conditions in the foreseeable future. 
  

 5. 

 4.3 Disposition of Warrant and Exercise Shares. 

(a) The Holder will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to
buy, purchase or otherwise acquire or take a pledge of) this Warrant or any of the Exercise Shares except in compliance with the Act, applicable blue sky laws, and the rules and regulations promulgated thereunder. The Holder further agrees not to
engage in hedging transactions with regard to such securities unless in compliance with the Act. 
 (b) The Holder
further agrees not to make any disposition of all or any part of the Warrant or Exercise Shares in any event unless and until: 

(i) The Company shall have received a letter secured by the Holder from the Securities and Exchange Commission stating that no
action will be recommended to the Commission with respect to the proposed disposition; 
 (ii) There is then in effect a
registration statement under the Act covering such proposed disposition and such disposition is made in accordance with said registration statement, or pursuant to an exemption from registration; or 

(iii) The Holder shall have notified the Company of the proposed disposition and shall have furnished the Company with a detailed
statement of the circumstances surrounding the proposed disposition, and if reasonably requested by the Company, the Holder shall have furnished the Company with an opinion of counsel, reasonably satisfactory to the Company, for the Holder to the
effect that such disposition will not require registration of such Warrant or Exercise Shares under the Act or any applicable state securities laws. 

(c) The Holder understands and agrees that all certificates evidencing the shares to be issued to the Holder may bear the
following legend (in addition to any legend required under applicable state or foreign securities laws): 
 THE SHARES
REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED PURSUANT TO REGULATION S OF THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”), AND MAY NOT BE OFFERED, SOLD, MORTGAGED OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED EXCEPT IN
ACCORDANCE WITH REGULATION S, PURSUANT TO A REGISTRATION UNDER THE ACT, OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL IN FORM AND SUBSTANCE REASONABLY SATISFACTORY TO THE
ISSUER TO THE EFFECT THAT ANY PROPOSED TRANSFER OR RESALE IS IN COMPLIANCE WITH THE ACT AND ANY APPLICABLE SECURITIES LAWS. 

5. REPRESENTATIONS OF COMPANY. The Company represents and warrants to the Holder
that: 
  

 6. 

 5.1 Authorization. All corporate action on the part of the Company, its officers,
directors and stockholders necessary for the authorization, execution and delivery of this Warrant, the performance of all obligations of the Company hereunder and the authorization, issuance (or reservation for issuance), sale and delivery of the
Exercise Shares has been taken, and this Warrant, when executed and delivered by the Company, shall constitute valid and legally binding obligations of the Company, enforceable against the Company in accordance with its terms except (i) as
limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, or other laws of general application relating to or affecting the enforcement of creditors’ rights generally or (ii) as limited by laws
relating to the availability of specific performance, injunctive relief, or other equitable remedies. 
 5.2 Organization.
The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to own its properties and assets, to carry on its business as
presently conducted or as proposed to be conducted. 
 6. ADJUSTMENT OF EXERCISE
PRICE, ETC. 
 6.1 Adjustments for Reclassification, Exchange or Substitution,
etc. In the event of changes in the outstanding Series A Stock or as applicable the outstanding Common Stock of the Company by reason of stock dividends, split-ups, recapitalizations, reclassifications, combinations or exchanges of
shares, separations, reorganizations, liquidations, or the like, the number and class of shares available under the Warrant in the aggregate and the Exercise Price shall be correspondingly adjusted to give the Holder of the Warrant, on exercise for
the same aggregate Exercise Price, the total number, class, and kind of shares as the Holder would have owned had the Warrant been exercised prior to the event and had the Holder continued to hold such shares until after the event requiring
adjustment; provided, however, that such adjustment shall not be made with respect to, and, except as otherwise provided in Section 2.2 above, this Warrant shall terminate if not exercised prior to, the events set forth in Section 8 below.
The form of this Warrant need not be changed because of any adjustment in the number of Exercise Shares subject to this Warrant. 

7. FRACTIONAL SHARES. No fractional shares shall be issued upon the exercise of this Warrant
as a consequence of any adjustment pursuant hereto. All Exercise Shares (including fractions) issuable upon exercise of this Warrant may be aggregated for purposes of determining whether the exercise would result in the issuance of any fractional
share. If, after aggregation, the exercise would result in the issuance of a fractional share, the Company shall, in lieu of issuance of any fractional share, pay the Holder otherwise entitled to such fraction a sum in cash equal to the product
resulting from multiplying the then current fair market value of an Exercise Share by such fraction. 
 8.
EARLY TERMINATION. If after the date hereof the Company shall enter into any Reorganization (as hereinafter defined), then, as a condition of such Reorganization, lawful provisions shall be made, and duly
executed documents evidencing the same from the Company or its successor shall be delivered to the Holder, so that the Holder shall thereafter have the right to purchase, at a total price not to exceed that payable upon the exercise of this Warrant
in full, the kind and amount of shares of stock and other securities and property receivable upon such 
  

 7. 

 
Reorganization by a holder of the number of shares of Series A Stock which might have been purchased by the Holder immediately prior to such Reorganization, and in any such case appropriate
provisions shall be made with respect to the rights and interest of the Holder to the end that the provisions hereof (including without limitation, provisions for the adjustment of the Exercise Price and the number of shares issuable hereunder and
the provisions relating to the net issue election) shall thereafter be applicable in relation to any shares of stock or other securities and property thereafter deliverable upon exercise hereof. For the purposes of this Section 8, the term
"Reorganization" shall include without limitation any reclassification, capital reorganization or change of the Series A Stock (other than by reason of stock dividends, split-ups, recapitalizations, reclassifications, combinations or exchanges of
shares, separations, reorganizations, liquidations, or the like provided for in Section 6 hereof), or any consolidation of the Company with, or merger of the Company into, another corporation or other business organization (other than a merger
in which the Company is the surviving corporation and which does not result in any reclassification or change of the outstanding Series A Stock), or any sale or conveyance to another corporation or other business organization of all or substantially
all of the assets of the Company. 
 9. MARKET STANDOFF. [FOR KREOS’ SERIES
A REPLACEMENT WARRANT AND KREOS’ SERIES B WARRANT: Holder agrees, in connection with the Company’s sale of its Common Stock in a firm underwritten public offering pursuant to a registration statement under the Act, Holder agrees to
consider a request by the Company and its underwriters that (i) the Holder enter into an agreement that it shall not sell, make any short sale of, loan, grant any option for the purchase of, enter into any hedging or similar transaction with
the same economic effect as a sale, or otherwise dispose of any of the Company’s capital stock (or any securities convertible into the Company’s capital stock) held by Holder, however or whenever acquired (other than those included in the
registration or purchased subsequent to the initial public offering) without the prior written consent of Company or such underwriters, as the case may be, for such period of time (not to exceed one hundred and eighty (180) days, but subject to
such extension or extensions as may be required by the underwriters in order to publish research reports while complying with the Rule 2711 of the National Association of Securities Dealers, Inc., such extension or extensions not to exceed
thirty-four (34) days after the expiration of such 180-day period) from the effective date of such registration statement as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as
may be requested by the underwriters at the time of the Company’s initial public offering and (ii) that Holder provide such information as may be required by the Company or such representative in connection with the completion of any
public offering of the Company’s securities pursuant to a registration statement filed under the Act.] 
 [FOR THE
SVB SERIES B WARRANT: Holder shall not sell, make any short sale of, loan, grant any option for the purchase of, enter into any hedging or similar transaction with the same economic effect as a sale, or otherwise dispose of any of the
Company’s capital stock (or any securities convertible into the Company’s capital stock) held by Holder, however or whenever acquired (other than those included in the registration or purchased subsequent to the initial public offering)
without the prior written consent of Company or such underwriters, as the case may be, for such period of time (not to exceed one hundred and eighty (180) days, but subject to such extension or extensions as may be required by the underwriters
in order to publish research reports while complying with the Rule 2711 of the National Association of 
  

 8. 

 
Securities Dealers, Inc., such extension or extensions not to exceed thirty-four (34) days after the expiration of such 180-day period) from the effective date of such registration statement
as may be requested by the Company or such managing underwriters and to execute an agreement reflecting the foregoing as may be requested by the underwriters at the time of the Company’s initial public offering. Holder agrees to execute and
deliver such other agreements as may be reasonably requested by the Company or the underwriter that are consistent with the Holder’s obligations under this Section 9 or that are necessary to give further effect thereto. In addition, if
requested by the Company or the representative of the underwriters of the Company’s capital stock (or other securities) of the Company, Holder shall provide, within ten (10) days of such request, such information as may be required by the
Company or such representative in connection with the completion of any public offering of the Company’s securities pursuant to a registration statement filed under the Securities Act. In order to enforce the foregoing covenants, the Company
may impose stop-transfer instructions with respect to such capital stock (or other securities) until the end of such period. The underwriters of the Company’s stock are intended third party beneficiaries of this Section 9 and shall have
the right, power and authority to enforce the provisions hereof as though they were a party hereto.] 
 10.
NOTIFICATION OF CERTAIN EVENTS. Prior to the expiration of this Warrant pursuant to Section 8, in the event that the Company shall authorize: 

(a) the issuance of any dividend or other distribution on the capital stock of the Company (other than (i) dividends or
distributions otherwise provided for in Section 6, (ii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries upon termination of their employment or services
pursuant to agreements providing for the right of said repurchase; (iii) repurchases of common stock issued to or held by employees, officers, directors or consultants of the Company or its subsidiaries pursuant to rights of first refusal or
first offer contained in agreements providing for such rights; or (iv) repurchases of capital stock of the Company in connection with the settlement of disputes with any stockholder), whether in cash, property, stock or other securities;

 (b) the voluntary liquidation, dissolution or winding up of the Company; 

(c) any transaction resulting in the expiration of this Warrant pursuant to Section 8; or 

(d) receipt by the Company of any request for registration made pursuant to Section 1.2 or 1.4 of the Investor Rights
Agreement; 
 the Company shall send to the Holder of this Warrant at least ten (10) days prior written notice of the date on which a
record shall be taken for any such dividend or distribution specified in clause (a) or the expected effective date of any such other event specified in clause (b), (c) or (d), as applicable. The notice provisions set forth in this section
may be shortened or waived prospectively or retrospectively with the consent of the Holder. In addition, the Company shall deliver to the Holder copies of any proxy or information statements or other communications delivered to shareholders
generally. 
  

 9. 

 11. NO STOCKHOLDER RIGHTS. This Warrant
in and of itself shall not entitle the Holder to any voting rights or other rights as a stockholder of the Company. 
 12.
TRANSFER OF WARRANT. Subject to applicable laws and the restriction on transfer set forth on the first page of this Warrant, this Warrant and all rights hereunder are transferable, by the Holder in
person or by duly authorized attorney, upon delivery of this Warrant and the form of assignment attached hereto to any transferee designated by Holder. The transferee shall sign an investment letter in form and substance satisfactory to the Company.

 13. LOST, STOLEN, MUTILATED OR DESTROYED
WARRANT. If this Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender
thereof), issue a new Warrant of like denomination and tenor as the Warrant so lost, stolen, mutilated or destroyed. Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen,
mutilated or destroyed Warrant shall be at any time enforceable by anyone. 
 14. NOTICES, ETC.
All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed telex or facsimile if sent during normal business
hours of the recipient, if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a
nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the Company at the address listed on the signature page and to Holder at the addresses listed for Holder
above or at such other address as the Company or Holder may designate by ten (10) days advance written notice to the other parties hereto. 

15. ACCEPTANCE. Receipt of this Warrant by the Holder shall constitute acceptance of and agreement to all of the
terms and conditions contained herein. 
 16. GOVERNING LAW. This Warrant and all rights,
obligations and liabilities hereunder shall be governed by the laws of the State of Delaware. 
  

 10. 

 IN WITNESS WHEREOF, the
Company has caused this Warrant to be executed by its duly authorized officer as of             , 2010. 

 

			
	HORIZON PHARMA, INC.

			
		
	By:	 	  

			
		
	Name:	 	  

			
		
	Title:	 	  

			
		
	Address:	 	  

 

 11. 

 NOTICE OF EXERCISE 

TO: HORIZON PHARMA, INC. 

(1)  ̈ The undersigned hereby elects to purchase
             shares of the Series A Preferred Stock of Horizon Pharma, Inc. (the “Company”) pursuant to the terms of the attached Warrant, and tenders herewith payment of
the exercise price in full, together with all applicable transfer taxes, if any. 
  ̈
 The undersigned hereby elects to purchase              shares of the Series A Preferred Stock of the Company pursuant to the terms of the net exercise provisions set forth in
Section 2.1 of the attached Warrant, and shall tender payment of all applicable transfer taxes, if any. 
 (2)
Please issue a certificate or certificates representing said shares of Series A Preferred Stock in the name of the undersigned or in such other name as is specified below: 

 
  

(Name) 
  

 
  

 
 (Address)

 (3) The undersigned hereby restates and reaffirms the representations and covenants in Section 4 of the Warrant
with respect to the Exercise Shares to be received pursuant to this Notice of Exercise. 
  

					
	  
	 		 	  

	(Date)	 		 	(Signature)
			
		 		 	  

		 		 	(Print name)
			
	  
	 		 	  

	(Date)	 		 	(Signature)
			
		 		 	  

		 		 	(Print name)

  

 ASSIGNMENT FORM 

(To assign the foregoing Warrant, execute this form 

and supply required information. Do not use this 

form to purchase shares.) 

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced
thereby are hereby assigned to 
  

			
	Name:	 	  

	(Please Print)
		
	 Address:
	 	  

	 (Please Print)

 

					
	 Dated:             ,
20    
	  	
			
	Holder’s Signature:	 	  
	  	
			
	Holder’s Address:	 	  
	  	
			
	Holder’s Signature:	 	  
	  	
			
	Holder’s Address:	 	  
	  	

 NOTE: The signature to this Assignment Form must correspond with the name as it appears on the face of the
Warrant, without alteration or enlargement or any change whatever. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Warrant.Development and License Agreement

 Exhibit 10.8 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 

Confidential Treatment Requested 

Under 17 C.F.R. Sections 200.80(b)(4) 

and 230.406. 

EXECUTION COPY 

DATED 20 AUGUST 2004 

JAGOTEC AG 

and 

SKYEPHARMA AG 

and 

NITEC PHARMA AG 
  

 
 DEVELOPMENT & LICENCE
AGREEMENT 
  
  

 EXECUTION COPY 

THIS DEVELOPMENT and LICENCE AGREEMENT (this “Agreement”) is made on 20 August 2004 by and between: 

 

	(1)	JAGOTEC AG, a Swiss corporation having its place of business at Eptingerstrasse 5 1, CH-4 132 Muttenz, Switzerland (hereinafter referred to as
“Jagotec”); 

  

	(2)	SKYEPHARMA AG, a Swiss corporation having its place of business at Eptingersttasse 5 1, CH-4 132 Muttenz, Switzerland (hereinafter referred to as
“SkyePharma”; and SkyePharma and Jagotec hereinafter sometimes collectively referred to as “Skye”), and 

  

	(3)	NITEC PHARMA AG, a Swiss corporation, having a place of business at Röschenzerstrasse 9, CH-4153 Reinach, Switzerland (hereinafter referred to as
“Nitec”). 

 WITNESSES AS FOLLOWS: 
  

	A.	 By an agreement effective as of 18th day of August 1998, Skye and Merck KGaA, a German corporation, having a place of business Frankfurterstrasse 250,
D-64271 Darmstadt, Germany (hereinafter referred to as “Merck) entered into an agreement relating to the development of the product, Prednisone using certain proprietary technology and know-how owned by Jagotec relating to pharmaceutical
systems for the controlled and/or modified release of active substances, including but not limited to, Jagotec’s patented
GEOMATRIX® Technology (as defined below) (hereinafter called the “Merck Agreement”).

  

	B.	By an agreement between Merck and Nitec signed by Merck on 14 July 2004 and by Nitec on 2 August 2004 (the “Technology Transfer Agreement”), Merck
assigned the Merck Agreement to Nitec, effective as of the Effective Date of this Agreement. 

  

	C.	Skye has consented to the assignment of the Merck Agreement pursuant to the Technology Transfer Agreement, provided that certain modifications agreed between the
Parties (as defined below) are made to the contractual arrangements under the Merck Agreement. 

  

 1. 

 EXECUTION COPY 

 

	D.	On signature of this Agreement, the provisions of the Merck Agreement shall be terminated and replaced in their entirety with the terms and conditions set out below.

 NOW, THEREFORE, in consideration of the premises, mutual covenants and agreements contained in this Agreement and intending to
be legally bound by it, the Parties hereby agree as follows: 
  

	1	Definitions 

 For purposes of this
Agreement, the terms defined in this Section 1 shall have the following meanings: 
  

	1.1	“Active Drug” shall mean each of the substances Prednisone, Prednisolone and Methylprednisolone of a quality suitable for the manufacture of Product
meeting the Specifications; 

  

	1.2	“Affiliate” shall mean, any corporation, partnership or other entity controlled by, controlling or under common control with, either Party, with
“control” meaning (i) with respect to either Party direct or indirect beneficial ownership of more than 50% of the voting power of, or more than 50% of ownership interest in, such corporation, partnership or other entity and for the
avoidance of doubt, Jagotec and SkyePharma shall be regarded as Affiliates; 

  

	1.3	“Background IP” shall mean any intellectual property owned by the respective Parties on the Effective Date of this Agreement in respect of the Nitec
Know-How or the Skye Know-How which is or may be used under this Agreement and in the case of Nitec shall include all relevant rights intellectual property owned or used by Merck under the Merck Agreement necessary or desirable for use under this
Agreement; 

  

	1.4	 “Commercially Reasonable Efforts” means those efforts and resources that would be used by an established pharmaceutical company were
it developing, manufacturing, promoting and detailing its own pharmaceutical products which are of similar market potential as the Product, taking into account product labelling, market potential, past performance, economic return, the regulatory

  

 2. 

 EXECUTION COPY 

 

	 	 
environment and competitive market conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due. 

 

	1.5	“Confidential Information” shall mean any and all of the Skye Know-How and the Nitec Know-How, as well as any and all information developed during the
course of this Agreement, including, but not limited to, materials and techniques, analytical and testing methods, chemical formulae and specifications, product design criteria and test data, and technical information relating to product production
and commercial plans; 

  

	1.6	“Development Costs” shall mean all reasonable out-of-pocket costs (except those resulting from any breach by Skye hereunder) of the Development
Programme performed by Jagotec hereunder; 

  

	1.7	“Development Programme” shall mean the programme of work to be carried out by the Parties attached hereto as Exhibit C as may be amended by the Parties
in writing acting in good faith within thirty (30) days of the signature of this Agreement and thereafter as may be amended in writing by the Parties from time to time and “Development” shall be construed accordingly;

  

	1.8	“Dose Strength” shall mean with respect to Product each of the formulations containing 1, 2, 5 and 10 mg of Active Drug, respectively;

  

	1.9	“Effective Date” shall mean the date of signature of this Agreement; 

 

	1.10	“FDA” shall mean the U.S. Federal Food and Drug Administration and any successor agency thereof; 

 

	1.11	“First Launch” shall mean the first commercial sale of the Product in any country of the Territory to any unaffiliated third party in commercial
quantities following receipt of all applicable pricing and reimbursement approvals; 

  

	1.12	“Foreground IP” shall mean any intellectual property that arises or is developed by either party arising out of this Agreement;

  

	1.13	 “GEOMATRIX®
 Technology” shall mean all of Skye’s oral controlled and/or modified drug release delivery and related technologies together with all improvements thereon and thereto; 

 

	1.14	 “Intellectual Property” shall mean any patent, including patent applications, divisional, continuation or continuation-in-part
applications, re-issues, registered 

  

 3. 

 EXECUTION COPY 

 

	 	 
design copyright, database right, design right, topography right, trademark, service mark application to register any of such rights, trade secret, right in unpatented know-how and any other
intellectual or industrial property right of any nature whatsoever in any part of the world; 

  

	1.15	“Jagotec Manufacturing Agreement” shall mean the Manufacturing and Supply Agreement to be negotiated in good faith at the appropriate time by and
between Jagotec or any of its Affiliates and Nitec or any of its Affiliates on the manufacturing and supply of Product; 

  

	1.16	“Licence” shall mean the licence granted to Nitec as set out in Section 5.1; 

 

	1.17	“Mutual Recognition Procedure” shall mean the decentralized procedure to obtain a marketing authorisation for prescription drugs in EU countries;

  

	1.18	“Net Sales” shall mean, with respect to any Product, the invoiced sales price of such Product in finished package form invoiced by Nitec and/or its
Affiliates and/or its sub-licensee(s) to any independent customer other than Nitec Affiliates or sub-licensee(s), less only (a) sales, use, value added and other direct taxes (but excluding any income tax) actually incurred and paid by Nitec
and/or its Affiliates and/or its sub-licensee(s); and (b) customs duties, surcharges and other governmental charges incurred by Nitec and/or its Affiliates and/or its sublicensee(s) in connection with the exportation or importation of such
Product in final form, and (c) a lump sum deduction of [...***...] for all trade discounts, rebates, commissions, retroactive price reductions, amounts repaid or credited by reason of rejections, returns, and the like;

  

	1.19	“Nitec Know-How” shall mean all of Nitec’s and/or its Affiliates’ information and data (including, without limitation, information and data
of Merck under the Merck Agreement), which are not generally known including, but not limited to, patent claims and related information not yet disclosed to the public, formulae, procedures, protocols, techniques and results of experimentation and
testing which relate to Active Drug, and/or are useful and/or necessary to develop, make, use or sell any product containing Active Drug; 

  

	1.20	“Nitec Manufacturing Licence” shall mean the licence to Nitec granted pursuant to the option set out in Section 5.2; 

 

	1.21	“Party” or “Parties” shall mean SkyePharma, Jagotec and Nitec or any of them; 

 

 ***Confidential Treatment Requested 

 4. 

 EXECUTION COPY 

 

	1.22	 “Patents” shall mean all patents and patent applications heretofore or hereafter filed or having legal force in any country owned by
or licensed to Skye and/or its Affiliates relating to the Product, which claim the GEOMATRIX® Technology or the
process of manufacture by use of, or the use of, the GEOMATRIX® Technology and are set out in the attached
Exhibit A. Exhibit A is hereby deemed to be amended to include any and all patent applications relating to the subject matter of this Agreement eventually to be filed by or owned by or licensed to Skye or its Affiliates after the Effective Date,
together with any and all corresponding foreign patents and patent applications which issue therefrom, and all divisionals, continuations, continuations-in-part, reissues, renewals, extensions, substitutions, confirmations or additions to any such
patents or patent applications; 

  

	1.23	“Phase III Clinical Study” shall mean a large scale clinical trial in patients suffering from rheumatoid arthritis, the primary goal of which is to
establish Product efficacy (and chronic safety) according to Regulatory Authority registration rules or regulations; 

  

	1.24	 “Product” shall mean the pharmaceutical orally-administered controlled-release formulation (intended to exhibit a lag phase of at
least one hour, with substantially all of the drug release immediately thereafter) containing Prednisone, Prednisolone and/or Methylprednisolone, presented as a compressed tablet developed pursuant to this Agreement and using the
GEOMATRIX® Technology, and shall include all Dose Strengths unless otherwise explicitly stated;

  

	1.25	“Registration” shall mean the granting of any and all approvals and registrations of Product by any Regulatory Authority, including without limitation
price approval, which are required and/or necessary under any applicable law, rule, regulation or other governmental order to manufacture, market, distribute and sell Product in any country of the Territory; 

 

	1.26	“Regulatory Authority” shall mean the FDA and any equivalent competent regulatory authority in the other countries of the Territory;

  

	1.27	 “Skye Know-How” shall mean all of Skye’s and/or its Affiliates’ information and data, which are not generally known
including, but not limited to, patent 

  

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claims and related information not yet disclosed to the public, formulae, procedures, protocols, techniques and results of experimentation and testing, which relate to the
GEOMATRIX® Technology and/or are useful and/or necessary to develop, make, use or sell Products using the
GEOMATRIX® Technology; 

 

	1.28	“Specifications” shall mean the preliminary specifications of the Product set forth in Exhibit B attached hereto to be updated from time to time by
mutual agreement of the Parties; 

  

	1.29	“Technical Agreement” shall mean the additional contract to be entered into by Nitec as contract giver and Jagotec as contract acceptor, allocating the
respective pharmaceutical responsibilities relating to the manufacture and control of Products; 

  

	1.30	“Territory” shall mean all countries and territories in the world. 

 

	2	Development Preamble and further Development Programme 

  

	2.1	Jagotec has, prior to the execution of this Agreement, developed the Product under the Development and Licence Agreement with Merck, which shows some promising results.
In particular, the Parties have agreed to use the results as the basis of further development under this Agreement, the terms of which are hereby incorporated into this Agreement as set out below. 

 

	2.2	 Jagotec and Nitec undertake to conduct the further development of the Product in rheumatoid arthritis (and such other indications (e.g. asthma, IBD) as
may be agreed between the Parties in writing from time to time) in accordance with the Development Programme in an efficient and professional manner, and shall apply generally accepted Good Laboratory, Good Clinical and Good Manufacturing Practices
(each as applicable to pharmaceutical products for human use in the European Union and similar regulations applicable in other territories),. The Development shall also comply with the current guidelines of the European Union (e.g. Note for guidance
on quality of modified release products). Nitec shall actively support Jagotec regarding the development and studies to be executed by Jagotec under this Agreement as may be reasonably required by Jagotec from time to time. In particular, Nitec
shall provide information 

  

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reasonably requested by Jagotec relating to the Active Drug for the purposes of carrying out this development, including, but not limited to physico-chemical characteristics, safe-handling
instructions, in-vitro analytical methods, degradation products and standards and analytical methods therefore, all to the extent that any such information has not been delivered to Jagotec under the development and Licence Agreement with Merck. Any
costs and expenses incurred by Nitec in connection with such support shall be borne by Nitec. 

  

	2.3	Jagotec shall use all Active Drug supplied to it by Nitec hereunder solely and exclusively in connection with the Development. 

 

	2.4	Due to the nature and complexity of the development and the respective studies as set forth in this Agreement, the Parties recognize and acknowledge that problems and
delays might render the timeframe of the development difficult or impossible to accomplish. The Parties agree that they shall immediately inform each other in writing in the event that significant problems or delays are encountered or envisaged
during the course of the development and shall discuss such problems and delays in order to mutually agree on Commercially Reasonable Efforts to resolve such problems or delays. Nothing under this Section 2.4 shall affect the timelines set out
in Section 3 except to the extent of delays resulting directly from the breach of its obligations under this Agreement by Jagotec. 

  

	2.5	Nitec acknowledges and agrees that Jagotec’s obligations under this Agreement shall be strictly limited to the development steps and tasks explicitly listed and
described in the Development Programme, and that any amendment, change and alteration to, or extension of, any such development steps and tasks shall require the mutual agreement by the Parties. 

 

	2.6	Nitec shall bear all Development Costs. Nitec and Jagotec shall have the right to approve any additional activities not listed in Exhibit C which are proposed by
Jagotec or Nitec. 

  

	2.7	Nitec shall reimburse Jagotec on a quarterly basis any and all Development Cost incurred by Jagotec hereunder upon receipt of the respective invoices pursuant to
Section 2.9 below. 

  

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	2.8	During the term of this Agreement, Jagotec shall provide Nitec on a quarterly basis with an overview of the work intended by Jagotec to be performed according to the
Development Programme during the following three (3) months (hereinafter the “Quarterly Workplan”). Each such Quarterly Workplan shall contain information regarding the steps to be performed by Jagotec hereunder together with an
estimate of the man-hours expected to be spent on such steps and the anticipated Development Costs. Upon receipt of any such Quarterly Workplan, Nitec may comment thereon or disapprove certain steps included therein by written notice within five
(5) business day after receipt of each such Quarterly Workplan, provided that each Quarterly Workplan shall be deemed approved by Nitec if no such written notice is received by Jagotec within such five (5) business days, and provided
further that Jagotec shall have no responsibility for any delay in the Development Programme caused by or resulting from any such notice from Nitec. 

  

	2.9	Jagotec shall issue quarterly a report (“Quarterly Report”) reasonably detailing all development steps performed during the preceding three (3) month
period, and Jagotec shall, simultaneously with each such Quarterly Report, issue an invoice covering all cost and expenses incurred by Jagotec hereunder in accordance with the terms of this Agreement including any Development Costs over the period
covered by such Quarterly Report applying a rate of [...***...] per man-hour spent. Any excess of the aggregate amount of development fees paid by Nitec over the aggregate amount(s) invoiced by Jagotec shall be credited by Jagotec
against future invoices hereunder. 

  

	2.10	Nitec undertakes to settle each invoice so issued, which shows a balance in favour of Jagotec, within [...***...] as of the respective invoice date.

  

	3	Responsibilities 

  

	3.1	Nitec will use all Commercially Reasonable Efforts to perform at its sole cost and expense, the following: 

 

	(a)	all clinical studies, including without limitation: 

  

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	 	(i)	 commence the Phase III Clinical Study in Rheumatoid Arthritis as agreed with the German authority February,
17th 2004 within [...***...] of the Effective Date;

  

	 	(ii)	complete the above mentioned (3.1(a)(i) Phase III Clinical Study within [...***...] of commencing the Phase III Clinical Study, and;

  

	 	(iii)	other development steps and tasks (other than those which are assigned to Jagotec as may be agreed between the parties from time to time) which are required and/or
necessary and/or deemed reasonable to be performed pursuant to all applicable law, statute or regulation, in order to apply for, and subsequently receive, Registrations for Product in at least one major European market and eventually other countries
of the Territory; 

  

	(b)	apply for and diligently pursue, in Nitec’s (or its Affiliates’) own name; Registrations for Product in Rheumatoid Arthritis with the Regulatory Authorities
in at least one major European market within [...***...] of the completion of the Phase III clinical studies, and eventually other countries of the Territory; 

 

	(c)	apply for and diligently pursue (except where the primary obligation for doing so is placed on Jagotec under relevant legislation) any and all approvals required by any
applicable law, statute or regulation to manufacture Product at the manufacturing site as set forth in the Jagotec Manufacturing Agreement or any other facility to subsequently manufacture Product; 

 

	(d)	within [...***...] of the receipt of first Registration for Product in the reference member state, being such country referred to in Section 3.1(b), to start
and thereafter diligently pursue the Mutual Recognition Procedure or other procedure to obtain Registration in at least three other countries of the Territory; and 

 

	(e)	launch or have launched the Product in at least three European Union countries within [...***...] following receipt of Registration in those countries of the
European Union. 

  

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	3.2	Nitec may decide at its own discretion and according to its business strategy, in which country of the Territory to first apply for Registration of Product and initiate
and pursue the steps required to be performed for successful Registration of Product. 

  

	3.3	In the event that Nitec does not in any material respect meet any of its obligations pursuant to Section 3.1 above, Skye may thereafter call a meeting with Nitec
at which Skye will determine, at Jago’s sole option, either to (i) allow Nitec a further [...***...] to complete such obligation, or (ii) Skye to terminate the Agreement in which case the terms of Section 10.4
(c) shall apply. 

  

	3.4	Jagotec agrees to provide such technical assistance and consultation in addition to the tasks assigned to Jagotec pursuant to this Agreement as may be reasonably
required by Nitec in connection with the development, testing, performance of clinical studies, applications for Registrations or similar services, provided that Nitec shall pay to Jagotec an amount of [...***...] spent by Jagotec personnel in
providing such additional assistance and consultation. In addition to such fee, Nitec undertakes to reimburse Jagotec for all cost and expenses incurred in connection with travel and accommodation of Jagotec personnel providing upon specific request
by Nitec any such assistance and consultation at locations remote from their usual working location to the extent separately agreed upon. 

  

	3.5	Jagotec shall have no responsibility whatsoever in respect of the availability or quality of the results of the development steps to be performed by Nitec pursuant to
Section 3.1 above, unless otherwise agreed upon by the Parties in writing with respect to any specified development step or part thereof to be performed by Jagotec in accordance with Section 3.4 above. 

 

	3.6	 Nitec undertakes to provide to Jagotec upon availability with all information on any of the development steps performed by Nitec under Section 2.1
above in reasonable detail or as reasonably required by Jagotec to perform its obligation under this Agreement. In particular, but without limitation, Nitec shall provide Jagotec upon availability with results, data, reports and similar information
obtained by any of the studies, testing, Registration procedures or the like performed by Nitec under this Agreement. Any and all such information provided by Nitec to Jagotec shall be treated by Jagotec as Confidential Information and

  

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remain subject to the confidentiality and non-use obligations contained in Section 8 below. 

  

	3.7	In the event that the Parties shall deem the results of any of the development steps to be performed by Nitec under this Section 3, including without limitation,
the results of any clinical study (including Phase III Clinical Study) performed hereunder, to be unsatisfactory for any reason, the Parties may mutually agree to abandon the development of the Product under this Agreement and terminate this
Agreement with immediate effect. 

  

	3.8	The allocation of all technical and pharmaceutical responsibilities shall be included in the Technical Agreement which the Parties shall negotiate in good faith within
thirty (30) days of the Effective Date. 

  

	4	Proprietary Rights and Patents 

  

	4.1	Rights to Foreground IP 

  

	(a)	 Any Foreground IP relating specifically and exclusively to the
GEOMATRIX® Technology or the process of manufacture by use of, or the use of the
GEOMATRIX® Technology, including the formulation of any compound (including Active Drug) with
GEOMATRIX® Technology shall vest in and be owned absolutely by Jagotec, irrespective which party has created or
developed such Foreground IP or its contribution to it (hereinafter referred to as “Skye IPR”). 

  

	(b)	Any Foreground IP relating specifically and exclusively to the Product containing Active Drug, any use of the Active Drug, or any attribute or property of the Active
Drug, shall vest in and be owned absolutely by Nitec, irrespective which party has created or developed such Foreground IP or its contribution to it (hereinafter referred to as “Nitec IPR”). 

 

	(c)	All Foreground IP other than that set out in Section 4.1(a) and (b) will be owned (i) by the Party developing or discovering it; or (ii) if jointly
developed or discovered, shall be owned jointly (together, “Other IP”) all as determined in accordance with the legislation applying in the country or jurisdiction where such development or discovery shall take place.

  

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	4.2	Rights to Background IP 

  

	(a)	All Background IP is and shall remain the exclusive property of the party owning it (or if applicable from the third party from whom its rights to use the Background IP
has derived). 

  

	(b)	In case the Foreground IP of either party is dependent on any or all Background IP of the other party, the parties agree to the following: 

 

	 	(i)	in case Skye IPR or Other IP is dependent on any or all Background IP of Nitec (hereinafter referred to as “Dependent Skye IPR”), Nitec shall grant to Jagotec
a non-exclusive, perpetual, royalty-free right to use such Background IP with a right to grant sublicenses to the extent necessary for Jagotec and its licensees and sublicensees to make unrestricted use of its Foreground IP;

  

	 	(ii)	in case Nitec IPR or Other IP is dependent on any or all Background IP of Jagotec (hereinafter referred to as “Dependent Nitec IPR”), Jagotec shall grant to
Nitec a non-exclusive, perpetual, royalty-free right to use such Background IP with a right to grant sublicenses to the extent necessary for Nitec and its licensees and sublicensees to make unrestricted use of its Foreground IP.

  

	4.3	Confirmation by Jagotec 

 Jagotec
hereby confirms that neither it nor any of its Affiliates currently own any patent or patent application not included in the term “Patents”, which is reasonably necessary or useful to develop, manufacture, sell or otherwise dispose of a
Product under this Agreement. Future Skye IPR which may be necessary to develop, manufacture, sell or otherwise dispose of a Product under this Agreement will be deemed added to Exhibit A on filing. 

 

	4.4	Prosecution of Patent Applications 

  

	(a)	 During the term of this Agreement, Jagotec shall use all Commercially Reasonable Efforts, at its own cost, to prepare, prosecute and maintain all
patent applications and patents constituting Patents, and shall keep Nitec fully and promptly informed on any developments or changes relating thereto. If Jagotec decides not to further prosecute or not to maintain any patent application
constituting Patents, Jagotec shall promptly inform Nitec of such decision in writing, and the Parties shall, upon Nitec’s written request, meet to discuss any 

 

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appropriate action taking into due consideration Nitec’s interests under this Agreement. 

  

	(b)	Nitec shall be responsible for and shall use all Commercially Reasonable Efforts to control, at its own cost, the preparation, prosecution and maintenance of all Nitec
IPR and shall keep Jagotec fully and promptly informed on any developments or changes relating thereto. During the term of this Agreement, Nitec shall, at its sole cost, take all steps necessary to prosecute and maintain all Nitec IPR to the extent
Nitec deems commercially reasonable. If Nitec intends not to further prosecute and/or maintain any of the Nitec IPR, Nitec shall promptly inform Jagotec of such intention in writing, and Jagotec shall meet with Nitec to discuss any appropriate
action taking into due consideration Jagotec’s interests under this Agreement. 

  

	4.5	Notification of Infringement 

  

	(a)	If Nitec becomes aware of (i) any product or activity of any kind that involves or may involve an infringement or violation of Skye IPR, or (ii) any
third-party action, claim or dispute (including, but not limited to, actions for declaratory judgment alleging the invalidity or non-infringement) based upon or arising out of Skye IPR, then Nitec shall promptly notify Jagotec in writing of any such
infringement, violation, action, claim or dispute. 

  

	(b)	If Jagotec becomes aware of (i) any product or activity of any kind that involves or may involve an infringement or violation of Skye IPR with respect to Product
or of Nitec IPR, or (ii) any third-party action, claim or dispute (including, but not limited to, actions for declaratory judgment alleging the invalidity or non-infringement) based upon or arising out of Skye IPR with respect to Product or of
Nitec IPR, then Jagotec shall promptly notify Nitec in writing of any such infringement, violation, action, claim or dispute. 

  

	4.6	Enforcement of Skye IPR 

  

	(a)	 Jagotec, at its sole expense, shall have the right, but not the obligation, (1) to determine the appropriate course of action to enforce, or
otherwise abate the infringement of, or defend third-party actions regarding, Skye IPR and its Background IP to the extent necessary for the Dependent Nitec IPR (hereinafter referred to as “Skye IPR plus Background”), (ii) to take, or
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appropriate action to enforce, or defend third-party actions regarding, Skye IPR plus Background, (iii) to control any litigation or other enforcement action regarding Skye IPR plus
Background, and (iv) to enter into, or permit, the settlement of any such litigation or other enforcement action regarding Skye IPR plus Background. Notwithstanding anything contained in the preceding sentence, Jagotec shall not settle any suit
or action or otherwise consent to an adverse judgement in such suit or action without Nitec’s prior written consent, which consent shall not be withheld unreasonably. Jagotec shall keep Nitec informed on a regular basis on its taking or
refraining from taking, and the development of, any of the foregoing actions, and shall consider, in good faith, the interests of Nitec under this Agreement when taking any of the foregoing actions. Nitec shall, at its own cost, fully cooperate with
Jagotec in the planning and execution of any suit or other action to enforce, or defend third-party actions regarding, Skye IPR plus Background to the extent affecting Product and as reasonably required by Jagotec. 

 

	(b)	If Jagotec does not within [...***...], or any shorter delay imposed by any applicable law or regulation or court or authority having jurisdiction, after
receiving notice of any infringement or violation of Skye IPR plus Background which may adversely affect Product, or of any third-party action, claim or dispute based upon or arising out of Skye IPR plus Background which may adversely affect
Product, commence or take an action to enforce, or otherwise abate such infringement, or defend against such third-party action, then the Parties shall, upon Nitec’s written request, promptly meet to discuss any appropriate action with regard
to such enforcement of Skye IPR plus Background which may adversely affect Product. 

  

	(c)	Nitec, upon its written request and at its sole expense, shall be made an additional, not controlling party in any such suit or other action where necessary to obtain
complete relief regarding the subject infringement or violation. 

  

	4.7	Enforcement of Nitec IPR 

  

	(a)	 Nitec, at its sole expense, shall have the right, but not the obligation, (i) to determine the appropriate course of action to enforce, or
otherwise abate the infringement of, or defend third-party actions regarding, Nitec IPR and its 

  

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Background IP to the extent necessary for the Dependent Skye IPR (hereinafter referred to as “Nitec IPR plus Background”), (ii) to take, or refrain from taking, appropriate action
to enforce, or defend third-party actions regarding, Nitec IPR plus Background, (iii) to control any litigation or other enforcement action regarding Nitec IPR plus Background, and (iv) to enter into, or permit, the settlement of any such
litigation or other enforcement action regarding Nitec IPR plus Background. Notwithstanding anything contained in the preceding sentence, Nitec shall not settle any suit or action or otherwise consent to an adverse judgment in such suit or action
without the prior written consent of Jagotec, which consent shall not be withheld unreasonably. Nitec shall keep Jagotec informed on a regular basis on its taking or refraining from taking, and the development of, any of the foregoing actions, and
shall consider, in good faith, the interests of Jagotec under this Agreement and in Skye IPR, when taking any of the foregoing actions. Jagotec shall, at its own cost, fully cooperate with Nitec in the planning and execution of any suit or other
action to enforce, or defend third-party actions regarding, Nitec IPR plus Background to the extent affecting Product and as reasonably required by Nitec. 

 

	(b)	If Nitec does not, within [...***...], or any shorter delay imposed by any applicable law or regulation or court or authority having jurisdiction, after
receiving notice of any infringement or violation of Nitec IPR plus Background, or of any third-party action, claim or dispute based upon or arising out of Nitec IPR plus Background, commence or take an action to enforce, or otherwise abate such
infringement, or defend against such third-party action, then the Parties shall, upon Jagotec’s written request, promptly meet to discuss any appropriate action with regard to such enforcement of Nitec IPR plus Background which may adversely
affect Product 

  

	(c)	Jagotec, upon its written request and at its sole expense, shall be made an additional, not controlling party in any such suit or other action where necessary to obtain
complete relief regarding the subject infringement or violation. 

  

	4.8	Application of Monies Recovered 

All monies recovered upon the final judgment or settlement of any suit or other action under these Sections 3.6 or 3.7 above shall be
applied as follows: 
  

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	 	(i)	firstly, to cover any and all costs and expenses (including attorney’s fees) incurred by the Party controlling such suit or other action; 

 

	 	(ii)	secondly, to cover any and all costs and expenses (including attorney’s fees) reasonably, or upon request of the controlling Party, incurred by the other Party in
connection with such suit or other action, if any; 

  

	 	(iii)	finally, the remainder, if any, to the Party controlling any such suit or other action. 

 

	5	Licence Grant 

  

	5.1	 Jagotec hereby grants to Nitec the royalty bearing exclusive and sub-licensable right and licence to market, distribute, sell, offer for sale and use
the Product in the Territory and to use the Patents, GEOMATRIX® Technology and Skye Know How exclusively for
that purpose. 

  

	5.2	 Furthermore, subject to the provisions of Section 6.2, Jagotec hereby grants to Nitec the option (the “Option”) to acquire the exclusive
and sublicenseable right and licence (hereinafter referred to as the “Nitec Manufacturing Licence “) to make or have made Product in the Territory and to use the Patents,
GEOMATRIX® Technology and Skye Know How exclusively for that purpose at any time on twenty four month notice to
expire no earlier than five years after the First Launch of the Product in the Territory. The Option may be exercised in accordance with Section 6.2 below. For the avoidance of doubt, no royalty in addition to that set out in Section 7
shall be payable by Nitec to Jagotec in respect of the Nitec Manufacturing Licence. The Nitec Manufacturing Licence shall be co-terminus with the licence granted under Section 5.1. 

 

	5.3	Subject to the provisions of Section 5.5, the rights of Nitec to grant any sub-license under the Licence and/or the Nitec Manufacturing Licence, as the case may
be, in any part of the Territory shall not require Nitec to receive the written approval of Jagotec. 

  

	5.4	 In any event, Nitec shall be responsible for any and all acts, deeds and undertakings of its sub-licensee(s) and shall continue to be bound by all
terms and provisions under this Agreement throughout its term. In case that Nitec sub-

  

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licenses rights and/or the Licence and/or the Nitec Manufacturing Licence, as the case may be, to any sub-licensee(s), such sub-licensee(s) shall agree in writing to any and all of Nitec’s
obligations and undertakings under this Agreement, including but not limited to its confidentiality obligations set out below. Furthermore, Nitec undertakes that any and all sub-licence agreements shall provide for inspection and audit provisions
identical to the provisions set forth below in order to enable Jagotec to control and audit and receive any and all Royalties due as provided in this Agreement. Nitec shall provide Jagotec promptly with appropriate information on its sub-licensee(s)
and, subject to applicable confidentiality restrictions, copies of all agreements with such sub-licensee(s). 

  

	6	Manufacturing and Product Liability 

  

	6.1	 Subject to the exercise by Nitec of its rights under Section 6.2, Jagotec shall exclusively manufacture, package and supply, or have manufactured,
packaged and supplied by an Affiliate, Product in bulk in accordance with the terms and conditions to be agreed upon in the Jagotec Manufacturing Agreement, which Jagotec Manufacturing Agreement shall contain provisions (i) that Nitec shall
supply to Jagotec or its Affiliate free of charge all Active Drug in quantities required for such manufacturing of Product, and (ii) on manufacture and packaging of Product in bulk and reimbursement of cost at [...***...] of
Jago’s fully allocated manufacturing cost therefore (calculated in substantially the same manner as Jago’s other manufactured products of similar production process, run and complexity) as required by the Parties. If Jagotec wants to have
the product manufactured, packed and supplied by an affiliate other than SkyePharma SAS, the costs of the manufacturing site change to such an affiliate (including but not limited to technical transfer, process validation, bioequivalence study and
regulatory expenses) shall be borne by Skye. Furthermore, the Jagotec Manufacturing Agreement shall contain provisions on lead times, order quantity and supply and purchase obligations of such quantities ordered (or part thereof), as may be mutually
agreed upon by the Parties and in the event of a failure by the Parties to agree by 31 March, 2005, each Party shall submit the matter to be resolved by an expert, to be appointed by

  

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a single arbitrator appointed under ICC Rules. With the exception of the principles applied in calculating the fully allocated manufacturing cost referred to above, in relation to any particular
proposed clause of the Jagotec Manufacturing Agreement on which the Parties are unable to agree, each Party shall propose terms, only one of which, subject to such amendments specified by the expert as shall be required to ensure that the Jagotec
Manufacturing Agreement operates as a whole, shall be selected by the expert as the relevant clause of the Jagotec Manufacturing Agreement binding on the Parties. In the case of the principles applied in calculating the fully allocated manufacturing
cost referred to above, the expert shall not be bound only to select terms proposed by one Party or the other as described above but shall be free to make such amendments to proposed terms as the expert shall think fit. 

 

	6.2	In the event that Nitec wishes to manufacture the Product under the Nitec Manufacturing Licence rather then having Jagotec manufacture the Product under the Jagotec
Manufacturing Agreement, then Nitec shall exercise its Option under Section 5.2 above by serving notice on Jagotec to that effect in writing. Subject to the proviso to this sentence, the right of Nitec under Section 5.2 shall not take
effect for a period of [...***...] from the date of notice and during such period, (i) all pending orders for Product shall be satisfied by Jagotec in accordance with the Jagotec Manufacturing Agreement, and (ii) the Parties will
agree the terms of the royalty free Manufacturing Licence to include such provisions as are customary in the circumstances, failing which either Party may refer the matter to an expert for determination. Jagotec agrees that it shall provide
technical assistance in connection with such transfer to a third party manufacturer as set out in Section 3.4. The costs of the manufacturing site change (including but not limited to technical transfer, process validation, bioequivalence study
and regulatory expenses) shall be born by Nitec. Notwithstanding anything to the contrary contained herein, following exercise of the Option, the Manufacturing License shall be an irrevocable worldwide, fully paid-up, royalty-free license, pursuant
to which Nitec and its licensees shall have a right of sublicense. 

  

	6.3	 Nitec shall indemnify, defend and hold Jagotec and its Affiliates, directors, officers and shareholders harmless from and against any losses, claims,
liabilities, 

  

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costs and expenses (including reasonable attorney’s fees) that may be imposed upon or asserted against Jagotec and/or its Affiliates, directors, officers and shareholders as a result of the
manufacture of Product under the Manufacturing License, or the marketing, distribution, use or sale of Product under the License by or on behalf of Nitec, its Affiliates, agents or sub-licensee(s), except for those claims, liabilities, costs and
expenses arising from negligence or intentional misconduct on the part of Jagotec or its Affiliates and except for claims to the extent any relate to the Patents,
GEOMATRIX® Technology and Skye Know How. 

 

	6.4	In the event that Jagotec wishes to cease to manufacture the Product under the Jagotec Manufacturing Agreement, Jagotec shall be permitted to do so by serving notice on
Nitec to that effect in writing. The termination under this Section 6.4 shall not take effect for a period of [...***...] from the date of notice and in any event no earlier than five years after the First Launch of the Product in
the Territory and during such period all pending orders for Product shall be satisfied by Jagotec in accordance with the Jagotec Manufacturing Agreement. Jagotec agrees that it shall provide technical assistance in connection with transfer of
manufacturing rights to a third party manufacturer as set out in Section 3.4. The costs of the manufacturing site change (including but not limited to technical transfer, process validation, bioequivalence study and regulatory expenses) shall
be born by Nitec. 

  

	7	Royalties 

  

	7.1	In consideration of the License granted by Jagotec to Nitec hereunder, the royalty (the “Royalty”) payable by Nitec to Jagotec shall be:

  

	 	7.1.1	in the case of all countries of the Territory (other than North America): 

  

	 	(a)	[...***...] of Net Sales of Product in the Territory (other than North America), and 

 

	 	(b)	[...***...] of sublicensing income in the Territory (other than North America) being any payment not calculated based on Net Sales (to include, without
limitation, licence fees, lump sums and milestone payments.). 

  

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	 	7.1.2	in the case of North America: 

  

	 	(a)	[...***...] of Net Sales of Product in North America, and 

  

	 	(b)	[...***...] of sublicensing income in North America being any payment not calculated based on Net Sales (to include, without limitation, licence fees, lump sums
and milestone payments.). 

  

	7.2	All Royalties shall be payable on a quarterly basis. Nitec shall remit to Jagotec within [...***...] days after the end of each calendar quarter the amount of
Royalties, if any, due in respect of the preceding quarter, beginning with the calendar quarter in which the First Launch takes place. Nitec shall deliver to Jagotec, along with such remittance of Royalty payments a detailed statement (hereinafter
referred to as the “Royalty Report’) of Net Sales of Product and sublicensing income received on a country-by-country basis to which the Royalty payment relates. 

 

	7.3	All Royalty Reports shall be prepared in accordance with generally accepted accounting principles consistently applied from applicable period to period and shall be
certified by an officer of Nitec as being so prepared, true, accurate and correct. 

  

	7.4	Unless otherwise agreed by the Parties in writing, all payments of Royalties shall be made in EURO and to such place or account as Jagotec reasonably requests from time
to time in writing. Any conversions into EURO from the currency in which the corresponding Net Sales for such Royalties and sublicensing income were made, are to be calculated by using the average closing buying rate for such currency quoted in the
continental terms method of quoting exchange rates (local currency per EURO 1) published by the Financial Times on the last business day of the applicable reporting period covered by such Royalty Report. 

 

	7.5	 In the event that Nitec is required to withhold any tax to the tax or revenue authorities in the Territory regarding any payment to Jagotec, such
amount shall be deducted from the payment to be made by Nitec, and Nitec shall promptly notify Jagotec of such withholding and, within a reasonable amount of time after making such deduction, furnish Jagotec with copies of any tax certificate or
other documentation evidencing such withholding. Each Party agrees to cooperate 

  

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with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect. 

 

	8	Inspection and Audit 

  

	8.1	During the term of this Agreement and during a period of twelve (12) months after its expiration or termination for any reason, upon the written request of Jagotec
and not more than once each calendar year, Nitec shall permit an independent certified public accountant of internationally recognized standing selected by Jagotec, to have access during regular business hours to such of the records of Nitec and its
Affiliates and sub-licensee(s), if any, as may be reasonably necessary to verify the accuracy of the Royalty Reports for any year ending not more than twenty-four (24) months prior to the date of such request. The accounting firm shall disclose
to Jagotec only whether the Royalty Reports and records of Nitec and its Affiliates and sub-licensee(s), if any, and the amount of Royalties, if any, actually paid are correct or not and the specific details concerning any discrepancies; no other
information shall be shared. The Parties agree to accept such written audit report as final and binding upon them. 

  

	8.2	If such independent accounting firm correctly concludes that additional Royalties were owed during any such period audited, Nitec shall pay such additional Royalties
within thirty (30) days of the date Jagotec delivers to Nitec such accounting firm’s written report so concluding. The fees and expenses charged by such accounting firm with respect to such audit shall be paid by Jagotec, provided however,
if any such audit discloses that Royalties payable by Nitec for the audited period are more than [...***...] of the Royalties actually paid for such period, then Nitec shall pay all reasonable fees and expenses charged by such
accounting firm with respect to such audit. 

  

	8.3	Jagotec shall treat all financial information subject to review under this Section 7 as confidential and subject to the confidentiality obligations in Article 8
below. 

  

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	9	Confidentiality 

  

	9.1	During the term of this Agreement and in the course of the development work by Jagotec, it may be necessary for each Party to disclose to the other Party, orally or in
writing, certain of its Confidential Information, which each Party considers to be confidential and proprietary. Each Party agrees to hold in strict confidence and not to use, except for purposes of this Agreement, all Confidential Information
obtained from the other Party during the term of this Agreement. 

  

	9.2	The obligations of confidentiality and non-use contained in this Section 8 shall not extend and apply to Confidential Information that: 

 

	(i)	is in or enters the public domain without breach of this Agreement; or 

  

	(ii)	can be shown to have been known to the receiving Party prior to disclosure under this Agreement; or 

 

	(iii)	is disclosed to the receiving Party, without restriction, by a third party having the right to disclose the same; or 

 

	(iv)	is required to be disclosed by a judicial or administrative authority of competent jurisdiction or by law after maximum practical notice to the originally disclosing
Party. 

  

	9.3	Confidential Information of the other Party shall be disclosed or made available by the receiving Party only to those employees of the receiving Party who have a need
to know such Confidential Information for the purposes of this Agreement. Furthermore, the Parties may also disclose Confidential Information to consultants hired by one or both of the Parties, provided the receiving Party’s consultant has a
need to know such Confidential Information for purposes of this Agreement and has previously signed a written confidentiality agreement or has otherwise agreed to such confidentiality obligation with the receiving Party which contains substantially
the same obligations of confidentiality and non-use as set forth in this Section 8, and which is broad enough to cover disclosures of Confidential Information from the originally disclosing Party. 

 

	9.4	 In the event of termination or expiration of this Agreement for whatsoever reason, each Party shall immediately return to the other all of the other
Party’s Confidential Information furnished in connection with this Agreement, including 

  

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every and all copies made thereof save for one copy of each item of Confidential Information, which may be retained in the legal department or lodged with the legal advisers of the receiving
Party exclusively in order to provide a record of Confidential Information disclosed and to so determine each receiving Party’s continuing obligations hereunder. 

 

	9.5	The obligations of confidentiality and non-use contained in this Section 8 shall survive the expiration or termination of this Agreement for any reason for a
period of five (5) years commencing upon the effective date of such termination or expiration. 

  

	10	Term and Termination 

  

	10.1	Term and Expiration 

  

	(a)	This Agreement shall terminate on the later of ten (10) years from the Effective Date or on the expiry on a country-by-country basis upon the expiration of the
last to expire of the Patents in each country of the Territory, unless earlier terminated in accordance with Sections 10.2 and 10.3 below. 

  

	(b)	Upon the expiration of this Agreement in each country of the Territory pursuant to Section 10.1 (a) above and payment of all Royalties and Manufacturing
Royalties, if any, due under this Agreement, the License and the Manufacturing License, if applicable, shall be deemed to be a perpetual, fully paid-up and royalty-free license for Product in each such country of the Territory.

  

	10.2	Termination for Cause 

 During the entire term of
this Agreement either Party may terminate this Agreement by giving to the other Party written notice to that effect, if any of the following events occur: 
  

	(a)	the other Party is in default or in breach of a term or provision hereof and such default or breach is material and continues and is not remedied within
[...***...] upon the other Party’s written request to remedy such default or breach; 

  

	(b)	the other Party shall commit a material breach of any of the confidentiality provisions of Section 9 above; or 

 

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	(c)	the other Party goes into liquidation, voluntarily or otherwise, other than for the sole purpose of reorganization, or goes into bankruptcy or makes an assignment for
the benefit of creditors, or in the event of a receiver being appointed of the other Party’s property or parts thereof). 

  

	10.3	Termination prior to Registration 

In addition and not in limitation to Section 3.7 above, as from the Effective Date throughout the term until the first Registration
for Product is granted by any Regulatory Authority in any country of the Territory, this Agreement may be terminated as follows: 
  

	(a)	by either Party, if such Party reasonably considers based on a determination, in accordance with sound scientific, pharmaceutical and medical judgment, of the results
achieved with respect to the Product during the development phase, and that Party can demonstrate that there is a technical, pharmaceutical or medical problem regarding the Product, which would make the Product unapprovable in all of the following
countries, USA, UK and Germany, with [...***...] prior notice, provided that such terminating Party, prior to having the right to terminate this Agreement in accordance herewith, has in all detail disclosed such determination and the
underlying reasons to the other Party and has taken in due consideration any comments of the other Party on such determination; and 

  

	(b)	by Nitec, if the first application for Registration of Product or any material part thereof is finally rejected or denied, or if any Regulatory Authority in the
country, where the first Registration of Product is applied for, imposes restrictions on or conditions for the commercialization of the Product which have a material negative impact on the marketability of the Product, or if all Registrations of
Product in all countries are withdrawn or cancelled by the competent Regulatory Authorities, with [...***...] prior written notice. 

  

	10.4	Effect of Termination 

  

	(a)	 The termination of this Agreement shall be without prejudice to any rights and obligations of either Party accrued prior to the effective date of such
termination. Nitec shall forthwith make all payments due and outstanding to Jagotec at the date of termination. Except as explicitly otherwise stated in this Agreement, 

 

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Jagotec shall not be obliged to refund upon termination of this Agreement to Nitec any payments made by Nitec to Jagotec prior to such termination pursuant to the provisions of this Agreement.

  

	(b)	 In the event of termination of this Agreement pursuant to Sections 10.2 and 10.3 above, then this Agreement (and any agreements entered into in
connection with it) shall immediately be terminated and, except as provided herein, Nitec shall immediately refrain from using directly or indirectly in any way the Patents,
GEOMATRIX® Technology and Skye Know-How. Upon termination of this Agreement, except as provided herein, Jagotec
shall immediately refrain from using directly or indirectly in any way all Nitec IPR as well as Nitec Know-How. Furthermore, each Party shall return to the other Party all Confidential Information (other than that relating to the Foreground IP of
the other) received from or belonging to the other Party, together with all copies thereof in such other Party’s possession or under its control, all free of any charge. Either Party shall have the right, but not the obligation, to use, at its
sole discretion, any and all such material for its own purposes. 

  

	(c)	 Subject to any rights of Merck under the Technology Transfer Agreement, in the event of termination by Jagotec under the terms of Section 3.3, the
terms of Section 10.4 (b) shall not apply and the Agreement (and any agreements entered into in connection with it) shall immediately be terminated and Nitec shall immediately refrain from using directly or indirectly in any way the
Patents, GEOMATRIX® Technology and Skye Know-How. At the same time, subject to any rights of Merck under the
Technology Transfer Agreement, Nitec shall grant to Jagotec the exclusive royalty free and, sublicenseable right and license to the Nitec IPR and the Nitec Know-How and any confidential information necessary or desirable for use with the Product in
the Territory and shall provide at no additional cost to Jagotec such information and documentation as shall be reasonably requested by Jagotec in that regard. 

 

	(d)	The termination for cause of this Agreement pursuant to Section 10.2 above by either Party shall not limit remedies which are or may be otherwise available in law
or equity to either Party. 

  

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	11	Representations and Warranties 

  

	11.1	 Jagotec represents and warrants that it shall carry out and undertake the development work until approval of the Product in the Territory in a careful
and diligent manner. Jagotec agrees to carefully choose, instruct and supervise any employees, officers, Affiliates or third parties to be chosen by it pursuant to this Agreement, who are involved in the Development of the Product. Nothing in this
Agreement shall be construed as a representation made, or warranty given, by Jagotec that any development performed by or for Jagotec under this Agreement will be successful in whole or in part, or that any product, including Product, which may be
developed, will be successful in the commercial marketplace. Furthermore, except as provided herein, Jagotec makes no representation or warranty, express or implied, with respect to
GEOMATRIX® Technology and/or Skye Know-How, including without limitation, any warranty of completeness,
accuracy, merchantability or fitness for a particular purpose. 

  

	11.2	 Jagotec represents and warrants that it has all rights regarding Patents,
GEOMATRIX® Technology and Skye Know-How necessary to grant the Licence and the Option and the Nitec
Manufacturing Licence hereunder. Notwithstanding the preceding sentence but subject to the following sentence, Jagotec does not assume any responsibility and makes no warranty that the performance of this Agreement and any product developed
hereunder, including the Product, do not infringe any third party’s patents, patent applications or other intellectual property rights. Notwithstanding the preceding sentence, Jagotec represents and warrants that, as of the Effective Date, it
is not aware and has no knowledge of any such infringement of any third party rights. If however, during the course of this Agreement either Party discovers that the Product infringes or may infringe any third party’s intellectual property
rights, it shall promptly inform the other Party thereof and the Parties shall meet to discuss the course of action to be taken with regard thereto. 

  

	11.3	Nothing in this Agreement shall be construed as a representation made, or warranty given by Jagotec that any patent will issue based upon any pending patent application
encompassed by the term Patents, and that any patent encompassed by the term Patents which issues will be valid or enforceable. 

  

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	11.4	Except as provided for in the Jagotec Manufacturing Agreement to be agreed upon in due time as referred to in Section 5.1 above, Jagotec assumes no liability or
responsibility for any damages caused to Nitec, third parties, and/or the environment by the manufacturing, marketing, distribution, sale or use of the Product or the Active Drug contained therein, except to the extent that any of the above are
attributable to the negligence or wilful misconduct of Jagotec in performing its obligations hereunder. 

  

	11.5	Nitec represents and warrants to strictly adhere at all times in all material respects to any and all laws, rules, regulations and conditions imposed by any competent
authority on the marketing, distribution and sale of Product, and Nitec shall during the entire term of this Agreement be solely and fully responsible for the compliance with all such laws, rules, regulations and conditions when marketing,
distributing and selling Product under the Licence. 

  

	11.6	Subject to the specific representations and warranties given and specific disclaimers of representations and warranties included in this Article 10, and further subject
to anything to the contrary contained in this Agreement, either Party shall, as to third parties, be indemnified and held harmless by the other Party from and against any and all losses, liabilities and damages arising from any claim, action or
other proceeding by any third party relating to any acts or omissions of the other Party, its directors, officers, employees or agents, or the gross negligence or wilful misconduct of such other Party, its directors, officers, employees or agents in
performing any of its obligations under this Agreement. 

  

	11.7	Any liability, warranty and undertaking contained herein shall be limited to the payment by either Party for direct damages to the other Party and in any event, neither
Party shall be liable to the other Party for any special, indirect, punitive or consequential damages and/or loss of profits or anticipated profits, respectively. 

 

	11.8	 Nitec shall, at its own expense, purchase from an insurance company of its choice and shall maintain during the entire term of this Agreement and
during [...***...] after its expiration or termination an appropriate and customary policy of general liability and product liability insurance covering its responsibilities, including in particular but without any limitation,
Nitec’s development responsibilities under Section 2 above, regarding Product developed, 

 

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manufactured, marketed, sold and used under this Agreement and the Active Drug contained therein and the use thereof. Upon request, Nitec shall provide Jagotec with evidence that such insurances
are existing and are maintained. 

  

	11.9	Nitec represents and warrants that, to the best of its knowledge and belief, having made due and careful investigation, it has acquired from Merck all relevant rights,
including but not limited to all relevant intellectual property rights of Merck in connection with the Merck Agreement to allow Nitec to carry out its obligations hereunder. Nitec shall indemnify Jagotec in respect of any breach thereof.

  

	11.10	Without prejudice and subject to the other terms of this Agreement, if Nitec determines that it requires a licence from a third party in order to manufacture, use,
sell, offer for sale or import the Product, including, without limitation, avoid infringement of any third party patent or in connection with settlement of any actual or threatened patent infringement claim, or if Nitec shall be subject to an order
or ruling of any court of competent jurisdiction requiring the payment of a royalty or other payment to a third party patent holder in respect of the manufacture, use, sale, offer for sale or import of the Product, then all such payments shall be
made at Nitec’s sole cost and expense. 

  

	12	Miscellaneous Provisions 

  

	12.1	Waivers: A waiver of a breach or default under this Agreement shall not be a waiver of any other or subsequent breach or default. The failure or delay by either Party
in enforcing compliance with any term or condition of this Agreement shall not constitute waiver of such term or condition, unless such term or condition is expressly waived in writing. 

 

	12.2	Headings: The titles and headings used in this Agreement are intended for convenience only and shall not in any way affect the meaning or construction of any provision
of this Agreement. 

  

	12.3	 Force Majeure: Neither Party shall be held in breach of this Agreement by any reason of acts or omissions caused by any Act of God or other causes
beyond the reasonable control of the affected Party. The affected Party shall use due 

  

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diligence to remove any such causes and to resume performance under this Agreement as soon as it is reasonably feasible. 

 

	12.4	Assignment: Except as otherwise expressly stated herein, this Agreement and the rights and obligations hereunder shall not be assignable by either Party without the
prior written consent of the other Party, provided however, that either Party may, without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate of such Party, and in connection with the transfer or sale of all
or substantially all of its business, or in the event of its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement so long as such assignee remains
liable on a joint and several basis for its obligations. 

  

	12.5	Separate Entities: Nothing in this Agreement shall constitute or be deemed to constitute a partnership between the Parties hereto or constitute or be deemed to
constitute either Party as an agent of the other for any purpose whatsoever, and neither Party shall have the authority or power to bind the other Party, or to contract in the name of and create a liability against the other Party in any way or for
any purpose, unless explicitly instructed in writing to do so. 

  

	12.6	Notices: All notices, reports and other writings which are required to be given or submitted pursuant to this Agreement shall be in writing and delivered personally or
sent by international courier service, or by confirmed facsimile transmission, to the addresses set forth below or to such other address as Jagotec or Nitec may from time to time notify to the other Party. Any and all notices sent to the other Party
in accordance with this Section 11.6 shall become effective as of receipt thereof by the other Party. 

 If to Skye,
SkyePharma or Jagotec: 
 Jagotec AG 

Eptingerstrasse 51 
 CH-4132 Muttenz, Switzerland

 Attn.: CEO 
 Fax: ++41-61-467-5574

  

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 with copy to: 

SkyePharma PLC 
 105 Piccadilly 

London W1J 7NJ 
 United Kingdom 

Attn.: General Counsel 
 Tel.:
+44-(0)20-7491-1777 
 Fax: +44-(0)20-7491-3338 

If to Nitec: 
 Nitec Pharma AG 

Röschenzerstrasse 9 
 CH-4153 Reinach,
Switzerland 
 Attn.:Verwaltungsrat 

Fax: +41 61 711 46 39 
  

	12.7	 Severability: Each Party hereby acknowledges that it does not intend to violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or community or association of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual consent,
valid provisions for such invalid provisions which valid provisions in their economic effect are sufficiently similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such
provisions. In case such provisions cannot be agreed upon, the invalidity of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid provisions are of such essential importance to
this Agreement that it is to be reasonably assumed that 

  

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the Parties would not have entered into this Agreement without the invalid provisions. 

  

	12.8	Interest: In the event any amount due and payable under this Agreement is not paid by the due date, then the Party owing such amount shall pay to the creditor, without
being requested by the other Party, interest on the total outstanding amount at the rate equal to the London Interbank Offered Rate (LIBOR), as published by the Financial Times on the date that such payment falls due, increased by
[...***...] in EURO and adjusted on the first day of every calendar quarter. 

  

	12.9	Entire Agreement: This Agreement, together with the Exhibits referred to herein and attached hereto, represents the entire understanding of the Parties with respect to
the subject matter hereof; and supersede all proposals or agreements, oral or written, and all other communications between the Parties related to the subject matter of this Agreement, including without limitation any representations or warranties
made by either Party hereto or its representatives. This Agreement may not be amended or modified except in a writing duly executed by the Parties. 

  

	13	Governing Law and Jurisdiction 

  

	13.1	The Parties hereto agree that this Agreement, including without limitation, all transactions affected hereunder, its validity and enforceability and all relationships
between the Parties in this connection shall be construed under and be governed in all respects by the laws of Switzerland without reference to the principles of conflicts of laws thereof and shall not be governed by the United Nations Convention on
Contracts for the International Sale of Goods (the Vienna Convention of April 11, 1980). 

  

	13.2	The Parties hereby agree that any and all disputes arising out of or in connection with this Agreement shall exclusively be submitted to and settled by the courts in
Zurich, Switzerland and the Parties hereby submit to such exclusive jurisdiction. 

  

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 This Agreement has been executed by Nitec and by Skye, by their duly authorized representatives, in
three (3) originals effective as of the Effective Date. 
  

									
	SKYEPHARMA AG	 		 		 	
					
	By:	 	/s/ Francesco Patalano	 		 	By:	 	/s/ Tessa Chapman
					
	Name:	 	Francesco Patalano	 		 	Name:	 	Tessa Chapman
					
	Title:	 	Director	 		 	Title:	 	Director
				
	JAGOTEC AG	 		 		 	
					
	By:	 	/s/ Francesco Patalano	 		 	By:	 	/s/ Tessa Chapman
					
	Name:	 	Francesco Patalano	 		 	Name:	 	Tessa Chapman
					
	Title:	 	Director	 		 	Title:	 	Director
				
	NITEC PHARMA AG:	 		 		 	
					
	By:	 	/s/ Dr. Hubertus Ludwig	 		 		 	
					
	Name:	 	Dr. Hubertus Ludwig	 		 		 	
					
	Title:	 	Verwaltungsrat	 		 		 	

  

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 Exhibit A 

Patents 
 [...***...] 

 

													
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
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	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
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	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]

 [...***...]

  

													
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]

***Confidential Treatment Requested 
  

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	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
	 [...***...]
	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]
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	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]	 	[...***...]

 [...***...]

 [...***...] 
  

													
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 ***Confidential Treatment Requested 

 34. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 35. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 36. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 37. 

 EXECUTION COPY 

 

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 ***Confidential Treatment Requested 

 38. 

 EXECUTION COPY 

 

													
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 ***Confidential Treatment Requested 

 39. 

 EXECUTION COPY 

 

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 ***Confidential Treatment Requested 

 40. 

 EXECUTION COPY 

 

 Exhibit B 

Preliminary Specifications for Product 

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 Exhibit C 

Development Programme 
  

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 ***Confidential Treatment Requested 

 41. 

 EXECUTION COPY 

 

 Exhibit D 

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 ***Confidential Treatment Requested 

 42.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00176-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00176-of-00352.parquet"}]]