EX-10.5



 Exhibit 10.5 

Standard Form (PPI, April 2, 2010) 

 
  

			
		 	 ***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 240.24b-2.


 Manufacturing Services Agreement 

November 15, 2010 







 Standard Form (PPI, April 2, 2010) 

 
  

Table of Contents 
  

							
	 ARTICLE 1
	  	 	1	 
		
	 INTERPRETATION
	  	 	1	 
			
	     1.1
	  	 DEFINITIONS
	  	 	1	 
	     1.2
	  	 CURRENCY
	  	 	5	 
	     1.3
	  	 SECTIONS AND HEADINGS
	  	 	5	 
	     1.4
	  	 SINGULAR TERMS
	  	 	5	 
	     1.5
	  	 SCHEDULES
	  	 	6	 
		
	 ARTICLE 2
	  	 	7	 
		
	 PATHEON’S MANUFACTURING SERVICES
	  	 	7	 
			
	     2.1
	  	 MANUFACTURING SERVICES
	  	 	7	 
	     2.2
	  	 ACTIVE MATERIAL YIELD
	  	 	8	 
		
	 ARTICLE 3
	  	 	10	 
		
	 CLIENT’S OBLIGATIONS
	  	 	10	 
			
	     3.1
	  	 PAYMENT
	  	 	10	 
	     3.2
	  	 ACTIVE MATERIALS
	  	 	10	 
		
	 ARTICLE 4
	  	 	11	 
		
	 CONVERSION FEES AND COMPONENT COSTS
	  	 	11	 
			
	     4.1
	  	 FIRST YEAR PRICING
	  	 	11	 
	     4.2
	  	 PRICE ADJUSTMENTS — SUBSEQUENT
YEARS’ PRICING
	  	 	11	 
	     4.3
	  	 PRICE ADJUSTMENTS CURRENT YEAR
PRICING
	  	 	12	 
	     4.4
	  	 ADJUSTMENTS DUE TO TECHNICAL
CHANGES
	  	 	13	 
	     4.5
	  	 MULTI-COUNTRY PACKAGING
REQUIREMENTS
	  	 	13	 
		
	 ARTICLE 5
	  	 	13	 
		
	 ORDERS, SHIPMENT, INVOICING, PAYMENT
	  	 	13	 
			
	     5.1
	  	 ORDERS AND FORECASTS
	  	 	13	 
	     5.2
	  	 RELIANCE BY PATHEON
	  	 	14	 
	     5.3
	  	 MINIMUM ORDERS
	  	 	15	 
	     5.4
	  	 SHIPMENTS
	  	 	15	 
	     5.5
	  	 ON TIME DELIVERY 
	  	 	15	 
	     5.6
	  	 INVOICES AND PAYMENT
	  	 	16	 
		
	 ARTICLE 6
	  	 	16	 
		
	 PRODUCT CLAIMS AND RECALLS
	  	 	16	 
			
	     6.1
	  	 PRODUCT CLAIMS
	  	 	16	 
	     6.2
	  	 PRODUCT RECALLS AND
RETURNS
	  	 	17	 
	     6.3
	  	 PATHEON’S RESPONSIBILITY
FOR DEFECTIVE AND RECALLED PRODUCTS.
	  	 	18	 


  
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 Standard Form (PPI, April 2, 2010) 

 
  

							
	     6.4
	  	 DISPOSITION OF DEFECTIVE OR
RECALLED PRODUCTS
	  	 	19	 
	     6.5
	  	 HEALTHCARE PROVIDER OR PATIENT
QUESTIONS AND COMPLAINTS
	  	 	19	 
	     6.6
	  	 [...***...]
	  	 	19	 
		
	 ARTICLE 7
	  	 	19	 
		
	 CO-OPERATION
	  	 	19	 
			
	     7.1
	  	 [...***...] REVIEW
	  	 	19	 
	     7.2
	  	 GOVERNMENTAL AGENCIES
	  	 	19	 
	     7.3
	  	 RECORDS AND ACCOUNTING BY
PATHEON
	  	 	20	 
	     7.4
	  	 INSPECTION
	  	 	20	 
	     7.5
	  	 ACCESS
	  	 	20	 
	     7.6
	  	 NOTIFICATION OF REGULATORY
INSPECTIONS
	  	 	20	 
	     7.7
	  	 REPORTS
	  	 	20	 
	     7.8
	  	 FDA FILINGS
	  	 	21	 
		
	 ARTICLE 8
	  	 	22	 
		
	 TERM AND TERMINATION
	  	 	22	 
			
	     8.1
	  	 INITIAL TERM
	  	 	22	 
	     8.2
	  	 TERMINATION FOR CAUSE
	  	 	22	 
	     8.3
	  	 PRODUCT DISCONTINUATION
	  	 	22	 
	     8.4
	  	 OBLIGATIONS ON TERMINATION
	  	 	23	 
		
	 ARTICLE 9
	  	 	24	 
		
	 REPRESENTATIONS, WARRANTIES AND COVENANTS
	  	 	24	 
			
	     9.1
	  	 AUTHORITY
	  	 	24	 
	     9.2
	  	 CLIENT WARRANTIES
	  	 	24	 
	     9.3
	  	 PATHEON WARRANTIES
	  	 	25	 
	     9.4
	  	 DEBARRED PERSONS
	  	 	25	 
	     9.5
	  	 PERMITS
	  	 	25	 
	     9.6
	  	 NO WARRANTY
	  	 	25	 
		
	 ARTICLE 10
	  	 	26	 
		
	 REMEDIES AND INDEMNITIES
	  	 	26	 
			
	     10.1
	  	 CONSEQUENTIAL DAMAGES
	  	 	26	 
	     10.2
	  	 LIMITATION OF LIABILITY
	  	 	26	 
	     10.3
	  	 PATHEON
	  	 	26	 
	     10.4
	  	 CLIENT
	  	 	26	 
	     10.5
	  	 REASONABLE ALLOCATION OF
RISK
	  	 	27	 
		
	 ARTICLE 11
	  	 	27	 
		
	 CONFIDENTIALITY
	  	 	27	 
			
	     11.1
	  	 CONFIDENTIALITY
	  	 	27	 

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 Standard Form (PPI, April 2, 2010) 

 
  

							
	 ARTICLE 12
	  	 	27	 
		
	 DISPUTE RESOLUTION
	  	 	27	 
			
	     12.1
	  	 COMMERCIAL DISPUTES
	  	 	27	 
	     12.2
	  	 TECHNICAL DISPUTE RESOLUTION
	  	 	28	 
		
	 ARTICLE 13
	  	 	28	 
		
	 MISCELLANEOUS
	  	 	28	 
			
	     13.1
	  	 INVENTIONS
	  	 	28	 
	     13.2
	  	 INTELLECTUAL PROPERTY
	  	 	29	 
	     13.3
	  	 INSURANCE
	  	 	29	 
	     13.4
	  	 INDEPENDENT CONTRACTORS
	  	 	29	 
	     13.5
	  	 NO WAIVER
	  	 	29	 
	     13.6
	  	 ASSIGNMENT
	  	 	29	 
	     13.7
	  	 FORCE MAJEURE
	  	 	30	 
	     13.8
	  	 ADDITIONAL PRODUCT
	  	 	30	 
	     13.9
	  	 NOTICES
	  	 	30	 
	     13.10
	  	 SEVERABILITY
	  	 	31	 
	     13.11
	  	 ENTIRE AGREEMENT
	  	 	31	 
	     13.12
	  	 OTHER TERMS
	  	 	32	 
	     13.13
	  	 NO THIRD PARTY BENEFIT
OR RIGHT
	  	 	32	 
	     13.14
	  	 EXECUTION IN COUNTERPARTS
	  	 	32	 
	     13.15
	  	 USE OF CLIENT NAME
	  	 	32	 
	     13.16
	  	 GOVERNING LAW
	  	 	32	 


  
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 Standard Form (PPI, April 2, 2010) 

 
  

MANUFACTURING SERVICES AGREEMENT 

THIS MANUFACTURING SERVICES AGREEMENT (the “Agreement”) is made as of November 15, 2010 (the
“Effective Date”) 
 BETWEEN: 

PATHEON PHARMACEUTICALS INC., 

a corporation existing under the laws of the State of Delaware 

(“Patheon”), 

- and - 

RAPTOR THERAPEUTICS, INC., 

a corporation existing under the laws of the State of Delaware 

(“Client”) 

THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and
valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound the parties agree as follows: 

ARTICLE 1 
 INTERPRETATION 

 

	 1.1
	 Definitions. 



The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations
of these terms will have corresponding meanings: 
 “Active Materials”, “Active Pharmaceutical
Ingredients” or “API” means the materials listed on Schedule D; 
 “Active Materials Credit
Value” means the value of the Active Materials for certain purposes of this Agreement, as set forth on Schedule D; 

“Actual Annual Yield” or “AAY” has the meaning specified in Section 2.2(a); 

“Affiliate” means 
  

	 	 (a)
	 a business entity which owns, directly or indirectly, a controlling interest in a party to this Agreement, by stock
ownership or otherwise; or 


  

	 	 (b)
	 a business entity which is controlled by a party to this Agreement, either directly or indirectly, by stock ownership or
otherwise; or 


  

	 	 (c)
	 a business entity. the controlling interest of which is directly or indirectly common to the majority ownership of a
party to this Agreement; 



  
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 Standard Form (PPI, April 2, 2010) 

 
  

For this definition, “control” means the ownership of shares carrying at least a majority of the votes for the election
of the directors of a corporation. 
 “Annual Product Review Report” means the annual product review report prepared
by Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e); 
 “Annual
Report” means the annual report to the FDA prepared by Client regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2); 

“Annual Volume” means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in
Schedule B; 
 “Applicable Laws” means (i) for Patheon, all the Laws of State of Ohio and all other state and
federal laws applicable to the manufacture of the Products; and (ii) for Client and the Products. the Laws of all jurisdictions where the Products are manufactured, distributed, and marketed as these are agreed and understood by the parties in
this Agreement; 
 “Authority” means any governmental or regulatory authority, department, body or agency or any
court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal; 

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

“Breach Notice” will have the meaning specified in Section 8.2(a); 

“Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the State of Ohio or
the State of California; 
 “cGMPs” means current good manufacturing practices as described in Parts 210 and 211 of
Title 21 of the United States’ Code of Federal Regulations together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time; 

“Client Intellectual Property” means Intellectual Property generated or derived by Client before entering into this
Agreement, or by Patheon while performing any Manufacturing Services or otherwise generated or derived by Patheon in its business which Intellectual Property is specific to, or dependent upon, Client’s Active Material or Product; 

“Client Property” will have the meaning specified in Section 8.4(f); 

“CMC” has the meaning specified in Section 7.8(c); 

“Components” means, collectively, all packaging components, raw materials, and ingredients (including labels, product
inserts and other labelling for the Products), 
  
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 Standard Form (PPI, April 2, 2010) 

 
  

required to manufacture the Products in accordance with the Specifications, other than the Active Materials; 

“Confidentiality Agreement” means the agreement about the non-disclosure of
confidential information between Patheon and Client (formerly know as Bennu Pharmaceuticals, Inc.) [...***...]; 

“Deficiency” has the meaning specified in Section 7.8(d); 

“Deficiency Notice” has the meaning specified in Section 6.1(a); 

“Delivery Date” means the date scheduled for shipment of Product under a Firm Order as set forth in Section 5.1(e);

 [“Equipment” will have the meaning ascribed to it in {the Capital Equipment Agreement related to this MSA if any}]

 “FDA” means the United States Food and Drug Administration; 

“Firm Orders” has the meaning specified in Section 5.1(c); 

“First Firm Order” has the meaning specified in Section 5.1(b); 

“Force Majeure” will have the meaning specified in Section 13.7; 

“Initial Manufacturing Month” has the meaning specified in Section 5.1(b); 

“Initial Manufacturing Period” has the meaning specified in Section 5.1(b); 

“Initial Term” has the meaning specified in Section 8.1; 

“Intellectual Property” includes, without limitation, rights in patents, patent applications, formulae: trade-marks,
trade-mark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and know how; 

“Invention” means information about any innovation, improvement, development, discovery, computer program, device.
trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable
or copyrightable; 
 “Inventory” means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials; 

“Late Delivery” has the meaning specified in Section 5.5: 

“Laws” means all laws, statutes, ordinances, regulations, rules, by-laws,
judgments, decrees or orders of any Authority; 
  
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 Standard Form (PPI, April 2, 2010) 

 
  

“Manufacturing Services” means the manufacturing, quality control, quality assurance, stability testing, packaging, and
related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components; 

“Manufacturing Site” means the facility owned and operated by Patheon that is located at 2110 East Galbraith Road,
Cincinnati, OH 45237-1625; 
 “Materials” means all Components, [...***...], and other materials used to
manufacture the Product other than Active Materials; 
 [...***...]; 

“Minimum Run Quantity” means the minimum number of batches of a Product to be produced during the same cycle of
manufacturing as set forth in Schedule B; 
 “Patheon Intellectual Property” means Intellectual Property generated or
derived by Patheon before performing any Manufacturing Services, Intellectual Property developed by Patheon while performing the Manufacturing Services, or otherwise generated or derived by Patheon in its business which Intellectual Property is not
specific to, or dependent upon. Client’s Active Material or Product including, without limitation, Inventions and Intellectual Property which may apply to manufacturing processes or the formulation or development of drug products, drug product
dosage forms or drug delivery systems unrelated to the specific requirements of the Product(s); 
 “Price” means the
price measured in US Dollars to be charged by Patheon for performing the Manufacturing Services, and includes the cost of Components. certain cost items as set forth in Schedule B, and annual stability testing costs as set forth in Schedule C. 

“Product(s)” means the product(s) listed on Schedule A; 

“Quality Agreement” means the agreement (the form of which is set forth in Schedule F) between the parties setting out
the quality assurance standards for the Manufacturing Services to be performed by Patheon for Client; 
 “Recall” has
the meaning specified in Section 6.2(a); 
 “Regulatory Authority” means the FDA and any other foreign regulatory
agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory; 

“RFID” means Radio Frequency Identification Devices which (at present or in the future) may be affixed to Products or
Materials to assist in inventory control, tracking, and identification; 
 “Remediation Period” has the meaning
specified in Section 8.2(a); 
 “Shortfall” has the meaning specified in Section 2.2(b); 

 
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 Standard Form (PPI, April 2, 2010) 

 
  

“Specifications” means the file, for each Product, which is given by Client to Patheon in accordance with the procedures
listed in Schedule A and which contains documents relating to each Product, including, without limitation: 
  

	 	 (a)
	 specifications for Active Materials and Components; 



 

	 	 (b)
	 manufacturing specifications, directions, and processes; 



 

	 	 (c)
	 storage requirements; 


  

	 	 (d)
	 all environmental, health and safety information for each the Product including material safety data sheets; and



  

	 	 (e)
	 the finished Product specifications, packaging specifications and shipping requirements for each Product;



 all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement;

 “Target Yield” has the meaning specified in Section 2 2(a); 

“Target Yield Determination Batches” has the meaning specified in Section 2.2(a); 

“Technical Dispute” has the meaning specified in Section 12.2; 

“Territory” means [...***...]; 

“Third Party Rights” means the Intellectual Property of any third party; 

“Year” means in the first year of this Agreement the period from the Effective Date up to and including
December 31 of the same calendar year, and thereafter will mean a calendar year. 
  

	 1.2
	 Currency. 



Unless otherwise indicated. all monetary amounts are expressed in this Agreement in the lawful currency of the United States of America.

  

	 1.3
	 Sections and Headings. 



The division of this Agreement into Articles, Sections, Subsections, and Schedules and the insertion of headings are for convenience of
reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement. In this Agreement, the terms
‘‘this Agreement”, “hereof’, “herein”, “hereunder” and similar expressions refer to this Agreement and not to any particular part, Section or Schedule of this
Agreement. 
  

	 1.4
	 Singular Terms. 



Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural
and vice versa. 
  
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 Standard Form (PPI, April 2, 2010) 

 
  
  

	 1.5
	 Schedules. 



The following Schedules are attached to, incorporated in, and form part of this Agreement: 

 

			
	 Schedule A -
	  	 Product List and Specifications

	 Schedule B -
	  	 Minimum Run Quantity, Annual Volume, and Price

	 Schedule C -
	  	 Annual Stability Testing

	 Schedule D -
	  	 Active Materials, Active Materials Credit Value, and [...***...]

	 Schedule E -
	  	 Technical Dispute Resolution

	 Schedule F -
	  	 Commercial Quality Agreement

	 Schedule G -
	  	 (Reserved)

	 Schedule H -
	  	 Quarterly Active Materials Inventory Report

	 Schedule I -
	  	 Report of Annual Active Materials inventory Reconciliation and Calculation of Actual Annual Yield

	 Schedule J -
	  	 (Reserved)

	 [Schedule K -
	  	 Capital Equipment Agreement]


  
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 Standard Form (PPI, April 2, 2010) 

 
  

ARTICLE 2 
 PATHEON’S MANUFACTURING
SERVICES 
  

	 2.1
	 Manufacturing Services. 



Patheon will perform the Manufacturing Services for the Territory for the fees specified in Schedules B and C to manufacture Products
for Client in accordance with Specifications and requirements in the Quality Agreement agreed to by the parties. Unless specifically agreed to by Client, Price for Products will include costs items. Schedule B sets forth a list of cost items that
are included in the Price for Products. If any cost items are to be excluded from the Price, Patheon will provide a list of the excluded items to Client in advance for approval. Client agrees to pay additional fees for the excluded items approved in
advance by Client. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld. If Manufacturing Services have not started within [...***...] of the
date of execution of this Agreement, Patheon may amend the fees set out in Schedules B and C. As long as Patheon is in compliance with the terms and conditions of this Agreement, Client will utilize Patheon to manufacture [...***...]. 

 

	 	 (a)
	 Conversion of Active Materials and Components. Patheon will convert Active Materials and Components into
Products. 


  

	 	 (b)
	 Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing
specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s
standard operating procedures. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with
Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up
control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is Client property. 



 

	 	 (c)
	 Components. Patheon will purchase and test all Components (with the exception of those that are supplied by
Client) at Patheon’s expense and as required by the Specifications. 


  

	 	 (d)
	 Stability Testing. Patheon will conduct stability testing on the Products in accordance with the protocols set
out in the Specifications for the separate fees and during the time periods set out in Schedule C. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs.
Patheon will notify Client within one Business Day, after which Patheon and Client will jointly determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the
investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing 


  

***Confidential Treatment Requested 

  
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 Standard Form (PPI, April 2, 2010) 

 
  

	 	Services in accordance with the Specifications, cGMPs, and Applicable Laws. Patheon will give Client all stability test data and results at Client’s request. 


 

	 	 (e)
	 Packaging. Patheon will package the Products as set out in the Specifications. Client will be responsible for the
cost of artwork development. Patheon will determine and imprint the batch numbers and expiration dates for each Product shipped. The batch numbers and expiration dates will be affixed on the Products and on the shipping carton of each Product as
outlined in the Specifications and as required by cGMPs. Client may, in its sole discretion, make changes to labels, product inserts, and other packaging for the Products. Client will be responsible for the cost of labelling obsolescence when
changes occur, as contemplated in Section 4.4. Patheon’s name will not appear on the label or anywhere else on the Products unless: (i) required by any Laws; or (ii) Patheon consents in writing to the use of its name.



  

	 	 (f)
	 Active Materials and Client Supplied Components Importing. At least [...***...] before the scheduled
production date, Client will deliver the Active Materials to the Manufacturing Site [...***...] sufficient for Patheon to manufacture the desired quantities of Product and to ship Product on the Delivery Date. If the Active Materials are not
received [...***...] before the scheduled production date, the Firm Order may not be cancelled but Patheon may delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials. There will be no penalty
to Client under these circumstances. But if Patheon is unable to manufacture Product to meet this new shipment date due to prior third party production commitments, Patheon may delay the shipment until a later date as agreed to by the parties. All
shipments of Active Material will be accompanied by certificate(s) of analysis from the Active Material manufacturer and the Client, confirming the identity and purity of the Active Materials and its compliance with the Active Material
specifications. 


  

	 	 (g)
	 [...***...] 


  

	 	 (h)
	 Product Rejection for Finished Product Specification Failure. Internal process specifications will be
defined and mutually agreed upon. If Patheon manufactures Product in accordance with the agreed upon process specifications and a batch or portion of batch of Product does not meet a Finished Product Specification, [...***...]. If Client
previously paid for the non-conforming Product, Patheon will promptly, at Clients election, either: (i) refund the labor and overhead costs associated with such
non-conforming Product; or (ii) offset such costs against other amounts due to Patheon hereunder. 


  

	 	 2.2
	 Active Material Yield. 



 

	 	 (a)
	 Reporting. Patheon will give Client a [...***...] inventory report of the Active Materials held by Patheon
using the inventory report form set out in Schedule H, which will contain the following information for the quarter: 


  

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 Standard Form (PPI, April 2, 2010) 

 
  

Quantity Received: The total quantity of Active Materials that complies with the Specifications and is received at the
Manufacturing Site during the applicable period. 
 Quantity Dispensed: The total quantity of Active Materials dispensed at
the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less
the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products and, for certainty, will
not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and
(iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured during the
applicable period. 
 Quantity Converted: The total amount of Active Materials contained in the Products manufactured with the
Quantity Dispensed (including any additional Products produced in accordance with Section 6.1 or 6_2), delivered by Patheon, and not rejected, recalled or returned in accordance with Section 6.1 or 6.2 because of Patheon’s failure to
perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws. 
 Within [...***...] after
the end of each Year, Patheon will prepare an annual reconciliation of Active Materials on the reconciliation report form set forth in Schedule I including the calculation of the “Actual Annual Yield” or “AAY” for
the Product at the Manufacturing Site during the Year AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows: 

Quantity Converted during the Year    x    100% 

Quantity Dispensed during the Year 

After Patheon has produced a minimum of [...***...] successful commercial production batches of Product or has produced
commercial production batches for at least [...***...] at the Manufacturing Site (collectively, the “Target Yield Determination Batches”), the Parties will mutually agree on the target yield for the Product at the
Manufacturing Site (each, a “Target Yield”); The Target Yield will be revised [...***...] to reflect the actual manufacturing experience as agreed to by the parties. 

 

	 	 (b)
	 Shortfall Calculation. If the Actual Annual Yield falls more than [...***...] below the respective Target
Yield in a [...***...], then the shortfall for the [...***...] (the “Shortfall”) will be calculated as follows. 



[...***...] 
  

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 Standard Form (PPI, April 2, 2010) 

 
  
  

	 	 (c)
	 Credit for Shortfall. If there is a Shortfall for a Product in a Year, then Patheon will credit Client’s
account for the amount of the Shortfall not later than [...***...] after the end of the Year 


  

	 	     
	 Each credit under this Section 2.2(c) will be summarized on the reconciliation report form set forth in Schedule I. Upon
expiration or termination of this Agreement, any remaining credit owing under this Section 2.2 will be paid to Client. The Annual Shortfall, if any, will be disclosed by Patheon on the reconciliation report form. 



 

	 	 (d)
	 [...***...] 


  

	 	 (e)
	 No Material Breach. It will not be a material breach of this Agreement by Patheon under Section 8.2(a) if
the Actual Annual Yield is less than the Target Yield. 


 ARTICLE 3 

CLIENT’S OBLIGATIONS 
  

	 	 3.1
	 Payment. 



Client will pay Patheon for performing the Manufacturing Services according to the Prices specified in Schedules B and C. These prices
may be subject to adjustment under other parts of this Agreement. [...***...] Notwithstanding anything to the contrary, Patheon will not purchase nor will Client be obligated to reimburse Patheon for any cost items not included in Schedule B,
[...***...], without the prior written approval of Client. 
  

	 	 3.2
	 Active Materials. 



Client will [...***...], deliver the Active Materials to Patheon (in accordance with Section 2.1(f)) sufficient for Patheon to
manufacture the desired quantities of Product and to ship Product on the Delivery Date. If applicable, Patheon and the Client will reasonably cooperate to permit the import of the Active Materials into the United States. Client’s obligation
will include obtaining the proper release of the Active Materials from U.S. Customs and the FDA. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported into the United States. The Active
Materials will be held by Patheon on behalf of Client as set forth in this Agreement. Title to the Active Materials will at all times remain the property of Client. Any Active Materials received by Patheon will only be used by Patheon to perform the
Manufacturing Services. 
  
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ARTICLE 4 
 CONVERSION FEES AND COMPONENT
COSTS 
  

	 4.1
	 First Year Pricing. 



The [...***...] Price and annual stability Price for the Products for the first Year are listed in Schedules B and C and are
subject to the adjustments set forth in Sections 4.2 and 4.3. 
  

	 4.2
	 Price Adjustments — Subsequent Years’ Pricing. 



[...***...], Patheon may adjust the Price effective [...***...] as follows: 

 

	 	 (a)
	 Manufacturing Costs. Patheon may adjust the Price [...***...]. On or about [...***...], Patheon will
give Client a statement setting forth the [...***...] in calculating the Price [...***...] provided that no Prices may be increased until at least [...***...] after completion of all validation and test batches of the Products.



  

	 	 (b)
	 Component Costs. If Patheon incurs an increase in Component costs [...***...], it may increase the Price
for the next [...***...] to pass through the additional Component costs. On or about [...***...], Patheon will give Client information about the increase in Component costs which will be applied to the calculation of the Price for the
next Year to demonstrate that the Price increase is justified. Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers, provided that Patheon demonstrates using non-confidential means that the Price increase is justified. 


  

	 	 (c)
	 [...***...] 


  

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[...***...] 
  

	 	 (d)
	 [...***...] 



[...***...] 
  

	 4.3
	 Price Adjustments — Current Year Pricing 



During any Year of this Agreement, the Prices set out in Schedule B will be adjusted as follows: 

Extraordinary Increases in Component Costs. If, at any time, market conditions result in Patheon’s cost of Components being
materially greater than normal forecasted increases, then Patheon will be entitled to an adjustment to the Price for any affected Product to compensate it for the increased Component costs. Changes materially greater than normal forecasted increases
will have occurred if: [...***...]. If Component costs have been previously adjusted to reflect an increase in the cost of one or more Components, the adjustments set out in (i) and (ii) above will operate based on the last cost
adjustment for the Components. Notwithstanding the foregoing, no Prices may be increased until [...***...]. 
 For a Price adjustment
under this Section 4.3, Patheon will deliver to Client a revised Schedule B and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price adjustment is justified. Patheon will
have no obligation to deliver any supporting documents that are subject to obligations of confidentiality between Patheon and its suppliers. The revised Price will be effective for any Product delivered on or after the [...***...] following
Client’s receipt of the revised Schedule B. 
  
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 Standard Form (PPI, April 2, 2010) 

 
  
  

	 4.4
	 Adjustments Due to Technical Changes 



Amendments to the Specifications or the Quality Agreement requested by Client will only be implemented following a technical and cost
review by Patheon and are subject to Client and Patheon reaching agreement on Price changes required because of the amendment. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be
implemented following the written approval of Client, the approval not to be unreasonably withheld. If Client accepts a proposed Price change, the proposed change in the Specifications will be implemented. and the Price change will become effective,
only for those orders of Products that are manufactured under the revised Specifications. [...***...] Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order
to fill Firm Orders or under Section 5.2 will be cancelled where possible and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client if the Components cannot be used by other Patheon customers. 

 

	 4.5
	 Multi-Country Packaging Requirements. 



If Client decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will
inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional Component costs and the change over fees for the Product destined for each new country. The agreed
additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to this Agreement. 

ARTICLE 5 
 ORDERS, SHIPMENT, INVOICING,
PAYMENT 
  

	 5.1
	 Orders and Forecasts. 



 

	 	 (a)
	 Rolling [...***...] Forecast. When this Agreement is executed, Client will give
Patheon a non-binding [...***...] forecast of the volume of Product that Client expects to order in the first [...***...] of commercial manufacture of the Product. This forecast will then be updated by
Client on or before the [...***...] on a rolling forward basis. Client will update the forecast forthwith if it determines that the volumes estimated in the most recent forecast have changed by more than [...***...]. The most recent
[...***...] forecast will prevail. 


  

	 	 (b)
	 Firm Orders for Initial Manufacturing [...***...]. At least [...***...]
before the start of commercial manufacture of the Product, Client will update the rolling forecast for the first [...***...] of manufacture of the Product (the “Initial Manufacturing Period”). The [...***...] of this
updated forecast (“Initial Manufacturing Month”) will constitute a firm written order in the form of a purchase order or otherwise (“First Firm Order”) by Client to purchase and, 



 
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	 when accepted by Patheon, for Patheon to manufacture the quantity of the Product. If manufacturing has not started,
Client may cancel any Batches from the First Firm Order at no cost if notice of cancellation is received by Patheon [...***...] or more before the scheduled Delivery Date under the First Firm Order. If manufacturing has not started, Client may
cancel any Batches from the First Firm Order if notice of cancellation is received by Patheon [...***...] before the scheduled Delivery Date under the First Firm Order, [...***...]. The parties agree that this payment will be considered
liquidated damages for Patheon’s loss of manufacturing capacity due to the Client’s cancellation of manufacturing and will not be considered a penalty. If the First Firm Order is changed or adjusted as described above then the initial
rolling [...***...] forecast will also be adjusted as necessary. 


  

	 	 (c)
	 Firm Orders Thereafter. Before and during the Initial Manufacturing Period, and on a rolling basis during the
term of this Agreement, Client will issue an updated [...***...] forecast on or before [...***...]. The first [...***...] of this updated forecast will be a firm order in the form of a purchase order or otherwise (“Firm
Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of the Products on a date not less than [...***...] from the [...***...] immediately following the date that
the Firm Order is submitted. Firm Orders submitted to Patheon will specify Client’s Manufacturing Services purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely
manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm and binding on Client and may not be reduced by Client unless otherwise provided in this Agreement. 



 

	 	 (d)
	 [...***...] Forecast. On or before the [...***...], Client will give
Patheon a written non-binding [...***...] forecast, broken down by [...***...] for the [...***...] of the forecast, of the volume of each Product Client then anticipates will be required to be
manufactured and delivered to Client during the [...***...]. 


  

	 	 (e)
	 Acceptance of Firm Order. Patheon will accept Firm Orders by sending an acknowledgement to Client within
[...***...] of its receipt of the Firm Order. The acknowledgement will include, subject to confirmation from the Client, the Delivery Date for the Product ordered. The Delivery Date may be amended by agreement of the Parties or as set forth in
Sections 2.1(f) or 5.1(b). Patheon will accept all Firm Orders submitted by Client up to [...***...] of the quantities specified in the most recent forecast submitted by Client for the applicable period subject to the availability of Materials
and API. 


  

	 5.2
	 Reliance by Patheon. 



(a)    Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted
under Sections 5.1(a), (b), and (c) in ordering the Components required to meet the Firm Orders. In addition, Client understands that to ensure an orderly supply of the Components, Patheon may want to purchase the Components in sufficient
volumes to meet the production requirements for Products during part or all of the forecasted 
  

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periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Client. Accordingly, Client
authorizes Patheon to purchase Components to satisfy the Manufacturing Services requirements for Products for the first [...***...] contemplated in the most recent forecast given by Client under Section 5.1(a). Patheon may make other purchases
of Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the parties The Client will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which
will be considered a Firm Order when accepted by Patheon. If Components ordered by Patheon under Firm Orders or this Section 5.2 are not included in finished Products manufactured for Client, or in any third party products manufactured by
Patheon, [...***...] after the forecasted month for which the purchases have been made (or for a longer period as the parties may agree) or if the Components have expired during the period, then Client will pay to Patheon its costs therefor
(including all costs incurred by Patheon for the purchase and handling of the Components) But if these Components are used in Products subsequently manufactured for Client or in third party products manufactured by Patheon, Client will receive
credit for any costs of those Components previously paid to Patheon by Client. 
 (b)    If Client fails to take
possession or arrange for the destruction of Components within [...***...] of purchase or, in the case of finished Product, within [...***...] of manufacture, Client will pay Patheon $[...***...] thereafter for storing the
Components or finished Product. Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at $[...***...]. Storage fees are subject to a [...***...] minimum charge
[...***...]. Patheon may ship finished Product held by it longer than [...***...] to the Client at Client’s expense on [...***...] written notice to the Client. 

 

	 5.3
	 Minimum Orders. 



Client may only order Manufacturing Services for batches of Products in multiples of the Minimum Run Quantities as set out in Schedule
B. 
  

	 5.4
	 Shipments. 



Shipments of Products will be made [...***...] Patheon’s shipping point unless otherwise mutually agreed. Risk of loss or of
damage to Products will remain with Patheon until [...***...]. Patheon will, in accordance with Client’s instructions and as agent for Client, (i) arrange for shipping to be paid by Client and (ii) at Client’s risk and
expense, obtain any export licence or other official authorization necessary to export the Products. Client will arrange for insurance and will select the freight carrier used by Patheon to ship Products and may monitor Patheon’s shipping and
freight practices as they pertain to this Agreement. Products will be transported in accordance with the Specifications. 
  

	 5.5
	 On Time Delivery. 



 

	 (a)
	 Patheon and the Client understand that there may be uncertainties and necessary adjustments in production schedules
during the initial Manufacturing Period. The parties agree that they will work together closely to expedite deliveries and manage the scheduling of the initial Product launch. 



 
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	 (b)
	 If after the Initial Manufacturing Period, Patheon is unable to deliver the quantity of Product ordered under a Firm
Order on the Delivery Date due to an act or omission by Patheon (a “Late Delivery”), Client will receive a credit from Patheon for the Late Delivery that will be applied against the purchase price under the next Firm Order The
credit will be [...***...]. 


  

	 (c)
	 A Late Delivery will not be a material breach of this Agreement by Patheon for the purposes of Section 8.2 unless
the Products are delivered more than [...***...] after the Delivery Date. 


  

	 (d)
	 For clarity, a Late Delivery will not include any delay in shipment of Product caused by events outside of
Patheon’s reasonable control, such as [...***...]. 


  

	 (e)
	 Patheon will not ship Products to Client or its agents in advance of a scheduled delivery date, without Client’s
prior approval. 


  

	 (f)
	 No shipment will be deemed complete until all ordered Product SKUs have been delivered in accordance with Client’s
instructions and a certificate of compliance has been issued by Patheon Partial shipment must be authorized by Client. 


  

	 5.6
	 Invoices and Payment. 



Invoices will be sent by fax or email to the fax number or email address given by Client to Patheon in writing. Invoices will be sent
when the Product is manufactured and released by Patheon to the Client. Patheon will also submit to Client, with each shipment of Products, a duplicate copy of the invoice covering the shipment. Patheon will also give Client an invoice covering any
Inventory or Components which are to be purchased by Client under Section 5.2 of this Agreement Each invoice will, to the extent applicable, identify Client’s Manufacturing Services purchase order number, Product numbers, names and
quantities, unit price, freight charges, and the total amount to be paid by Client. Client will pay all undisputed invoices for accepted Products within [...***...] of the date thereof. No payment or other obligations of Client will accrue on
partial or incomplete shipments. Interest on past due accounts will accrue at [...***...]. The Late Delivery credits set forth in this Section 5 are only available to Client if all outstanding undisputed invoices have been paid in full or
are within [...***...] outstanding from the invoice date when the Late Delivery arose. 
 ARTICLE 6 

PRODUCT CLAIMS AND RECALLS 
  

	 6.1
	 Product Claims. 



(a)    Product Claims. Client has the right to reject any portion of any shipment of Products that deviates
from the Specifications, cGMPs, or Applicable Laws without invalidating any remainder of the shipment. Client will inspect the Products manufactured by Patheon upon receipt and will give Patheon written notice (a “Deficiency
Notice”) of all claims for Products that deviate from the Specifications, cGMPs, or Applicable Laws within [...***...] after Clients 
  

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receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within [...***...] after
discovery by Client, [...***...]). Should Client fail to give Patheon the Deficiency Notice within the applicable [...***...], then the delivery will be deemed to have been accepted by Client on the [...***...] after delivery or
discovery, as applicable. Except as set out in Section 6.3, Patheon will have no liability for any deviations for which it has not received notice within the applicable [...***...] period. 

(b)    Determination of Deficiency. Upon receipt of a Deficiency Notice, Patheon will have [...***...]
to advise Client by notice in writing that it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within [...***...] after Patheon’s notice to Client as to whether any Products identified in the
Deficiency Notice deviate from the Specifications, cGMPs, or Applicable Laws, then the parties will mutually select an independent laboratory to evaluate if the Products deviate from the Specifications, cGMPs, or Applicable Laws. This evaluation
will be binding on the parties. If the evaluation certifies that any Products deviate from the Specifications, cGMPs, or Applicable Laws, Client may reject those Products in the manner contemplated in this Section 6.1 and Patheon will be
responsible for the cost of the evaluation. If the evaluation does not so certify for any of the Products, then Client will be deemed to have accepted delivery of the Products on the [...***...] after delivery (or, in the case of any defects
not reasonably susceptible to discovery upon receipt of the Product, on the [...***...] after discovery thereof by Client, but not after the expiration date of the Product) and Client will be responsible for the cost of the evaluation. 

(c)    Shortages. Claims for shortages in the amount of Products shipped by Patheon will be dealt with by
reasonable agreement of the parties. 
  

	 6.2
	 Product Recalls and Returns. 



(a)    Records and Notice. Patheon and Client will each maintain records necessary to permit a Recall of any
Products delivered to Client or customers of Client. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Products or which might result in the Recall or seizure of the
Products. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Products in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary.
The decision to initiate a Recall or to take some other corrective action, if any, will be made and implemented by Client. “Recall” will mean any action (i) by Client to recover title to or possession of quantities of the
Products sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Products from the market); or (ii) by any regulatory authorities to detain or destroy any of the Products. Recall will also include any action
by either Party to refrain from selling or shipping quantities of the Products to third parties which would have been subject to a Recall if sold or shipped. 

(b)    Recalls. If (i) any governmental or regulatory authority issues a directive, order or, following
the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a
“Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.

  
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(c)    Product Returns. Client will have the responsibility for handling customer returns of the Products.
Patheon will give Client any assistance that Client may reasonably require to handle the returns. 
  

	 6.3
	 Patheon’s Responsibility for Defective and Recalled Products. 



(a)    Defective Product. If Client rejects Products under Section 6.1 and the deviation is determined
to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws. Patheon will credit Client’s account for Patheon’s invoice price for the defective Products.
If Client previously paid for the defective Products, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Products; (ii) offset the amount paid against other amounts due to Patheon
hereunder; or (iii) replace the Products with conforming Products without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials required for the manufacture of the
replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.2. 

(b)    Recalled Product. If a Recall or return results from, or arises out of, a failure by Patheon to
perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket
expenses of the Recall or return and will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products as soon as possible, contingent upon the receipt from Client of all Active Materials required for the
manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.2. If Patheon is
unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials), then Client may request Patheon to reimburse Client for the price that Client paid to Patheon for
Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client’s cost and expense. 

(c)    Except as set forth in Sections 6.3(a) and (b) above, Patheon will not be liable to Client nor have any
responsibility to Client for any deficiencies in, or other liabilities associated with, any Product manufactured by it, (collectively, “Product Claims”). For greater certainty, Patheon will have no obligation for any Product Claims
to the extent the Product Claim [...***...]. 
  
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	 6.4
	 Disposition of Defective or Recalled Products. 



Client will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon
without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct Client to return the Products to Patheon. Patheon will bear the cost of disposition for any damaged, defective, returned or Recalled Products for which
it bears responsibility under Section 6.3. [...***...] 
  

	 6.5
	 Healthcare Provider or Patient Questions and Complaints. 



Client will have the sole responsibility for responding to questions and complaints from its customers Questions or complaints received
by Patheon from Clients customer’s, healthcare providers or patients will be promptly referred to Client. Patheon will co-operate as reasonably required to allow Client to determine the cause of and
resolve any questions and complaints. This assistance will include follow-up investigations. including testing. In addition, Patheon will give Client all mutually agreed upon information that will enable
Client to respond properly to questions or complaints about the Products as set forth in the Quality Agreement. Unless it is determined that the cause of the complaint resulted from a failure by Patheon to perform the Manufacturing Services in
accordance with the Specifications, cGMPs, and Applicable Laws, all costs incurred under this Section 6.5 will be borne by Client. 
  

	 6.6
	 [...***...] 



[...***...] 
 ARTICLE 7

 CO-OPERATION 
  

	 7.1
	 [...***...] Review. 



Each party will forthwith upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for
liaison between the parties. The relationship managers will meet not less than [...***...] to review the current status of the business relationship and manage any issues that have arisen. 

 

	 7.2
	 Governmental Agencies. 



Subject to Section 7.8, each party may communicate with any governmental agency, including but not limited to governmental agencies
responsible for granting regulatory approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law,
governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive
copies of all communications from the agency. 
  
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	 7.3
	 Records and Accounting by Patheon. 



Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary
to comply with manufacturing regulatory requirements applicable to Patheon, as well as to assist with resolving Product complaints and other similar investigations. Copies of the records and samples will be retained for a period of one year
following the date of Product expiry, or longer if required by law or the Quality Agreement, at which time Client will be contacted concerning the delivery and destruction of the documents and/or samples of Products. Client is responsible for
retaining samples of the Products necessary to comply with the legal/regulatory requirements applicable to Client. 
  

	 7.4
	 Inspection. 



Client may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance
notice. but a Patheon representative must be present during the inspection. 
  

	 7.5
	 Access. 



Patheon will give Client reasonable access at mutually agreeable times to the areas of the Manufacturing Site in which the Products are
manufactured, stored, handled, or shipped to permit Client to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. But, with the exception of
“for-cause” audits, Client will be limited each Year to [...***...], lasting no more than [...***...], and involving no more than [...***...] auditors. Client may request additional
cGMP-type audits, additional audit days, or the participation of additional auditors subject to payment to Patheon of a fee of [...***...]. The right of access set forth in this Section 7.5 will not include a right to access or inspect
Patheon’s financial records. 
  

	 7.6
	 Notification of Regulatory Inspections. 



Patheon will notify Client within one Business Day of any inspections by any governmental agency specifically involving the Products.
Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products. 

 

	 7.7
	 Reports. 



Patheon will supply on an annual basis all Product data in its control, including release test results, complaint test results, and all
investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA. At the
Client’s request, Patheon will provide a copy of the Annual Product Review Report to the Client at no additional cost. Any additional report requested by Client beyond the scope of cGMPs and customary FDA requirements will be subject to an
additional fee to be agreed upon between Patheon and the Client. 
  

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	 7.8
	 FDA Filings. 



(a)    Regulatory Authority. Client will have the sole responsibility for filing all documents with all
Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture of the Products. Patheon will assist Client, to the extent consistent with
Patheon’s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture of all Products as quickly as reasonably possible. 

(b)    Verification of Data. At least [...***...] prior to filing any documents with any Regulatory
Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to
Patheon generated data 
 (c)    Verification of CMC. At least [...***...] prior to filing with any
Regulatory Authority any documentation which is or is equivalent to the FDA’s Chemistry and Manufacturing Controls (“CMC”) related to any Marketing Authorization, such as a New Drug Application or Abbreviated New Drug
Application, Client will give Patheon a copy of the CMC as well as all supporting documents which have been relied upon to prepare the CMC This disclosure will permit Patheon to verify that the CMC accurately describes the work that Patheon has
performed and the manufacturing processes that Patheon will perform under this Agreement. Client will give Patheon copies of all FDA filings at the time of submission which contain CMC information regarding the Product 

(d)    Deficiencies. lf, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of
the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the “Deficiencies”), Patheon will notify Client in writing of the Deficiencies. The parties will work together
to have the Deficiencies resolved prior to any pre-approval inspection. 

(e)    Client Responsibility. For clarity, the parties agree that in reviewing the documents referred to in
clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of
any application for receipt of an approval by a regulatory authority. The Client is solely responsibility for the preparation and filing of the application for approval by the regulatory authorities and any relevant costs will be borne by the
Client. 
 (f)     Inspection by Regulatory Authorities. If Client does not give Patheon the documents
requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a regulatory authority may be jeopardized, Patheon may, in its sole discretion. delay or postpone any inspection by
the regulatory authority until Patheon has reviewed the requested documents and is satisfied with their contents. 
  

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ARTICLE 8 
 TERM AND TERMINATION

  

	 8.1
	 Initial Term 



This Agreement will become effective as of the Effective Date and will continue until December 31, 2017 (the “Initial
Term”), unless terminated earlier by one of the parties in accordance herewith This Agreement will automatically continue after the Initial Term for successive terms of two years each unless either party gives written notice to the other
party of its intention to terminate this Agreement at least 18 months prior to the end of the then current term. 
  

	 8.2
	 Termination for Cause; Client Termination. 



(a)    Either party at its sole option may terminate this Agreement upon written notice where the other party has
failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement within [...***...] following receipt of a written notice (the “Remediation Period”) of the breach that
expressly states that it is a notice under this Section 8.2(a) (a “Breach Notice”). 

(b)    Either party at its sole option may immediately terminate this Agreement upon written notice, but without
prior advance notice. to the other party if: (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction: (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other
party; or (iii) this Agreement is assigned by the other party for the benefit of creditors. 
 (c)    Client
may terminate this Agreement as to any Product upon [...***...] prior written notice if any Authority takes any action, or raises any objection, that prevents Client from importing, exporting, purchasing, or selling the Product or if Client is
unable to secure a license for Patheon to manufacture the Product without infringing third party rights in the Product. But if this occurs, Client will still fulfill all of its obligations under Section 8.4 below [and under any Capital
Equipment Agreement regarding this Product]. 
 (d)    Patheon may terminate this Agreement upon [...***...]
prior written notice if Client assigns under Section 13.6 any of its rights under this Agreement to an assignee that, in the opinion of Patheon acting reasonably, is: (i) not a credit worthy substitute for Client; or (ii) a competitor
of Patheon; or (iii) an entity with whom Patheon has had prior unsatisfactory business relations. 

(e)    Client may terminate this Agreement upon [...***...] prior written notice to Patheon if Client enters
into a strategic arrangement with a third party that does not compete with Patheon by principally providing contract manufacturing services to third parties, and if the written notice of termination to Patheon is made within [...***...] after
the Effective Date of this Agreement. 
  

	 8.3
	 Product Discontinuation. 



Client may terminate this agreement with at least [...***...] advance notice to Patheon if it intends to no longer order
Manufacturing Services for a Product due to (i) Client’s 
  

***Confidential Treatment Requested 

  
 - 22 - 








 Standard Form (PPI, April 2, 2010) 

 
  

termination of sales of the Product in the Territory, or (ii) termination of clinical trials for the Product. 

 

	 8.4
	 Obligations on Termination. 



If this Agreement is completed, expires, or is terminated in whole or in part for any reason, then: 

 

	 	 (a)
	 Client will take delivery of and pay for all undelivered Products that are manufactured and/or packaged under a Firm
Order according to the terms of this Agreement, at the price in effect at the time the Firm Order was placed; 


  

	 	 (b)
	 Client will purchase, at Patheon’s cost (including all costs incurred by Patheon for the purchase and handling of
the Inventory). the Inventory applicable to the Products which was purchased, produced or maintained by Patheon in contemplation of filling Firm Orders; 


  

	 	 (c)
	 Client will satisfy the purchase price payable under Patheon’s orders with suppliers of Components, if the orders
were made by Patheon in reliance on Firm Orders; 


  

	 	 (d)
	 Patheon will return to Client all unused Active Materials (with shipping and related expenses, if any, to be borne by
Client); and 


  

	 	 (e)
	 Client acknowledges that no competitor of Patheon will be permitted access to the Manufacturing Site.



  

	 	 (f)
	 Patheon will, at its own expense. remove from Patheon site(s) and deliver to Client, within [...***...], all of
Client’s Components, Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, [E]equipment or other moveable property owned by Client, related to the Agreement and located at a Patheon site or that is
otherwise under Patheon’s care and control (“Client Property”). If Client requests that the Client Property be stored at Patheon, following the completion, termination, or expiration of the Agreement Client will pay Patheon
[...***...] thereafter for storing the Client Property and will assume any third party storage charges invoiced to Patheon regarding the Client Property. Patheon will invoice Client for the storage charges as set forth in Section 5.6 of
this Agreement. 


 Any termination or expiration of this Agreement will not affect any outstanding obligations or payments due
hereunder prior to the termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement [or any related Capital Equipment Agreement]. For greater certainty, termination of this Agreement for any
reason will not affect the obligations and responsibilities of the parties under Articles 10 and 11 and Sections 5.4, 5.6, 8.4, 13.1, 13.2, 13.3, and 13.15, all of which survive any termination. 

 
 ***Confidential Treatment Requested 

  
 - 23 - 








 Standard Form (PPI, April 2, 2010) 

 
  

ARTICLE 9 
 REPRESENTATIONS, WARRANTIES
AND COVENANTS 
  

	 9.1
	 Authority. 



Each party covenants, represents, and warrants that it has the full right and authority to enter into this Agreement and that it is not
aware of any impediment that would inhibit its ability to perform its obligations hereunder. 
  

	 9.2
	 Client Warranties. 



Client covenants, represents, and warrants that: 
  

	 	 (a)
	 Non-Infringement. 



 

	 	 (i)
	 the Specifications for each of the Products are its or its Affiliate’s property and that Client may lawfully
disclose the Specifications to Patheon; 


  

	 	 (ii)
	 any Client Intellectual Property, used by Patheon in performing the Manufacturing Services according to the
Specifications (A) is Clients or its Affiliates unencumbered property, (B) may be lawfully used as directed by Client, and (C) to the knowledge of Client, does not infringe and will not infringe any Third Party Rights;



  

	 	 (iii)
	 to the knowledge of Client, the performance of the Manufacturing Services by Patheon for any Product under this
Agreement or the use or other disposition of any Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights; 



 

	 	 (iv)
	 there are no actions or other legal proceedings, concerning the infringement of Third Party Rights related to any of the
Specifications, or any of the Active Materials and the Components, or the sale, use, or other disposition of any Product made in accordance with the Specifications; 



 

	 	 (b)
	 Quality and Compliance. 



 

	 	 (i)
	 the Specifications for all Products conform to all applicable cGMPs and Applicable Laws; 



 

	 	 (ii)
	 on the date of shipment, the API will conform to the specifications for the API that Client has given to Patheon and
that the API will be adequately contained, packaged, and labelled and will conform to the affirmations of fact on the container; 


  

	 	 (iii)
	 the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs
and Applicable Laws (i) may be lawfully sold and distributed in every jurisdiction in which Client markets the Products after separate approval, and (ii) to the knowledge of Client, will be safe for human consumption.




  
 - 24 - 








 Standard Form (PPI, April 2, 2010) 

 
  
  

	 9.3
	 Patheon Warranties. 



Patheon covenants, represents, and warrants that: 
  

	 	 (a)
	 it will perform the Manufacturing Services in a professional and workmanlike manner and in accordance with the
Specifications, cGMPs, and Applicable Laws, 


  

	 	 (b)
	 Patheon and its personnel performing the Manufacturing Services have the requisite experience, skills, knowledge, and
expertise necessary to perform the Manufacturing Services in a competent manner; 


  

	 	 (c)
	 any Patheon Intellectual Property used by Patheon to perform the Manufacturing Services (i) is Patheon’s or
its Affiliates unencumbered property, (ii) may be lawfully used by Patheon, and (iii) to the knowledge of Patheon, does not infringe and will not infringe any Third Party Rights; and 



 

	 	 (d)
	 the Products will be delivered free of all liens and encumbrances 



 

	 9.4
	 Debarred Persons. 



Patheon represents and warrants that it will not in the performance of its obligations under this Agreement use the services of any
person debarred or suspended under 21 U.S.C. §335(a) or (b), Patheon represents that it does not currently have, and covenants that it will not hire. as an officer or an employee any person who has been convicted of a felony under the laws of
the United States for conduct relating to the regulation of any drug product under the Federal Food, Drug, and Cosmetic Act (United States). 
  

	 9.5
	 Permits. 



Client will be solely responsible for obtaining or maintaining, on a timely basis, any permits or other regulatory approvals for the
Products or the Specifications, including, without limitation, all marketing and post-marketing approvals. 
 Patheon will maintain at
all relevant times all governmental permits, licenses, approval, and authorities required to enable it to lawfully and properly perform the Manufacturing Services. 
  

	 9.6
	 No Warranty. 



NEITHER PATHEON NOR CLIENT MAKE ANY WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET
FORTH IN THIS AGREEMENT. NEITHER PATHEON NOR CLIENT MAKES ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY FOR THE PRODUCTS. 

  
 - 25 - 








 Standard Form (PPI, April 2, 2010) 

 
  

ARTICLE 10 
 REMEDIES AND INDEMNITIES

  

	 10.1
	 Consequential Damages. 



Except for a party’s indemnification obligations under this Agreement, or due to a breach of Article 11, under no
circumstances whatsoever will either party be liable to the other in contract, tort, negligence, breach of statutory duty, or otherwise for (i) any (direct or indirect) loss of profits, of production, of anticipated savings, of business, or
goodwill or (ii) for any other liability, damage, costs, or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of these damages. 

 

	 10.2
	 Limitation of Liability. 



(a)    Active Materials. Except as expressly set forth in Section 2 2, under no circumstances will
Patheon be responsible for any loss or damage to the Active Materials. [...***...] 

(b)    [...***...] 
  

	 10.3
	 Patheon. 



Patheon agrees to defend, indemnify, and hold Client, its officers, employees, and agents harmless against any and all losses, damages,
costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting from, or relating to [...***...]. 

If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) use commercially reasonable efforts to mitigate
the effects of the claim, (c) reasonably cooperate with Patheon in the defense of the claim: and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon’s cost and expense. 

 

	 10.4
	 Client. 



Client agrees to defend, indemnify, and hold Patheon, its officers, employees, and agents harmless against any and all losses, damages,
costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting from, or relating to any [...***...] 
  

***Confidential Treatment Requested 

  
 - 26 - 








 Standard Form (PPI, April 2, 2010) 

 
  

[...***...]. 
 If a claim
occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client
to control the defense and settlement of the claim, all at Client’s cost and expense. 
  

	 10.5
	 Reasonable Allocation of Risk. 



This Agreement (including, without limitation, this Article 10) is reasonable and creates a reasonable allocation of risk for the
relative profits the parties each expect to derive from the Products. Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Client has developed and holds the marketing approval for
the Products, Client requires Patheon to manufacture and label the Products strictly in accordance with the Specifications, and Client, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of
the Products. 
 ARTICLE 11 

CONFIDENTIALITY 
  

	 11.1
	 Confidentiality. 



The Confidentiality Agreement will apply to all confidential information disclosed by the parties under this Agreement. If the
Confidentiality Agreement expires or is terminated prior to the expiration or termination of this Agreement, the terms of the Confidentiality Agreement will continue to govern the parties’ obligations of confidentiality for any confidential or
proprietary information disclosed by the parties hereunder, for the term of this Agreement, as though the Confidentiality Agreement remained in full force and effect. 

ARTICLE 12 
 DISPUTE RESOLUTION

  

	 12.1
	 Commercial Disputes. 



If any dispute arises out of this Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the
parties will first try to resolve it amicably In that regard, any party may send a notice of dispute to the other, and each party will appoint, within [...***...] from receipt of the notice of dispute, a single representative having full power
and authority to solve the dispute. The representatives will meet as necessary in order to resolve the dispute. If the representatives fail to resolve the matter within one month from their appointment, or if a party fails to appoint a
representative within the [...***...] period set forth above, the dispute will immediately be referred to the Chief Operating Officer (or another officer as he/she may designate) of each party who will meet and discuss as necessary to try to
resolve the dispute amicably. Should the parties fail to reach a resolution 
  

***Confidential Treatment Requested 

  
 - 27 - 








 Standard Form (PPI, April 2, 2010) 

 
  

under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.15. 

 

	 12.2
	 Technical Dispute Resolution. 



If a dispute arises (other than disputes under Sections 6.1(b) or 12.1) between the parties that is exclusively related to technical
aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage. or other activities under this Agreement (a “Technical Dispute”), the parties will make all reasonable efforts to resolve the dispute by
amicable negotiations. In that regard, senior representatives of each party will, as soon as practicable and in any event no later than [...***...] after a written request from either party to the other, meet in good faith to resolve any
Technical Dispute. If, despite this meeting, the parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within [...***...] of the written request, the Technical Dispute will, at the request of either
party, be referred for determination to an expert in accordance with Schedule E. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, the parties agree that the release of the
Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including
Schedule E) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution. 

ARTICLE 13 
 MISCELLANEOUS 

 

	 13.1
	 Inventions. 



(a)    For the term of this Agreement, Client hereby grants to Patheon a limited,
non-exclusive, paid-up, royalty-free, non-transferable, non-sublicensable license of
Client’s Intellectual Property which Patheon must use in order to perform the Manufacturing Services solely for use by Patheon in performing the Manufacturing Services. 

(b)    All Intellectual Property generated or derived by Patheon while performing the Manufacturing Services, to the
extent it is specific to the development, manufacture, use, and sale of Client’s Product that is the subject of the Manufacturing Services, will be the exclusive property of Client, and Patheon hereby assigns all of its right, title, and
interest in and to such Intellectual Property to Client. 
 (c)    All Patheon Intellectual Property will be the
exclusive property of Patheon. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive, paid-up, royalty-free, sublicensable, transferable license to use
the Patheon Intellectual Property used by Patheon to perform the Manufacturing Services or otherwise incorporated into the Products to make, use, sell, offer for sale, import, export, distribute, create derivative works of, and otherwise use the
Product(s) in any manner as contemplated under this Agreement. 
 (d)    Each party will be solely responsible for
the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions. 
  

***Confidential Treatment Requested 

  
 - 28 - 








 Standard Form (PPI, April 2, 2010) 

 
  

(e)    Either party will give the other party written notice, as promptly as practicable, of all Inventions which can
reasonably be deemed to constitute improvements or other modifications of the Products or processes or technology owned or otherwise controlled by the party. 
  

	 13.2
	 Intellectual Property. 



Subject to Section 13.1, all Client Intellectual Property will be owned by Client and all Patheon Intellectual Property will be
owned by Patheon. Neither party has, nor will it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing. Neither party will use any Intellectual Property of the other party,
except as specifically authorized by the other party or as required for the performance of its obligations under this Agreement. 
  

	 13.3
	 Insurance. 



Each party will maintain [...***...] insurance, including blanket contractual liability insurance covering the obligations of that
party under this Agreement through the term of this Agreement and for a period of [...***...] thereafter. This insurance will have policy limits of not less than [...***...]. If requested each party will give the other a certificate of
insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. The insurance certificate will further provide for a minimum of [...***...]
written notice to the insured of a cancellation of, or material change in, the insurance. If a party is unable to maintain the insurance policies required under this Agreement through no fault of its own, then the party will forthwith notify the
other party in writing and the parties will in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances. 

 

	 13.4
	 Independent Contractors. 



The parties are independent contractors and this Agreement will not be construed to create between Patheon and Client any other
relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the parties.

  

	 13.5
	 No Waiver. 



Either party’s failure to require the other party to comply with any provision of this Agreement will not be deemed a waiver of the
provision or any other provision of this Agreement, with the exception of Sections 6.1 and 8.2. 
  

	 13.6
	 Assignment. 


  

	 	 (a)
	 Patheon may not assign this Agreement or any of its rights or obligations hereunder without the written consent of
Client, this consent not to be unreasonably withheld. But Patheon may arrange for subcontractors to perform specific testing services arising under this Agreement without the consent of Client. 



 
 ***Confidential Treatment Requested 

  
 - 29 - 








 Standard Form (PPI, April 2, 2010) 

 
  
  

	 	 (b)
	 Subject to Section 8.2(d), Client may assign this Agreement or any of its rights or obligations hereunder without
approval from Patheon. But Client will give Patheon prior written notice of any assignment, any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement, and Client will remain liable hereunder. Any partial
assignment will be subject to Patheon’s cost review of the assigned Products and Patheon may terminate this Agreement or any assigned part thereof, on [...***...] written notice to Client and the assignee if good faith discussions do not
lead to agreement on amended Manufacturing Service fees within a reasonable time. 


  

	 	 (c)
	 Despite the foregoing provisions of this Section 13.6, and notwithstanding Section 8.2(d), either party may assign
this Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, but the assignee must execute an agreement with the non-assigning party whereby it agrees
to be bound hereunder. 


  

	 13.7
	 Force Majeure. 



Neither party will be liable for the failure to perform its obligations under this Agreement if the failure is caused by an event beyond
that party’s reasonable control, including, but not limited to, strikes or other labor disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in
transportation, defective equipment, lack of or inability to obtain fuel, power or components, or compliance with any order or regulation of any government entity acting within colour of right (a “Force Majeure Event”) A party
claiming a right to excused performance under this Section 13.7 will immediately notify the other party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the
performance. Neither party will be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement. 

 

	 13.8
	 Additional Product. 



Additional products may be added to this Agreement and the additional products will be governed by the general conditions hereof with
any special terms (including, without limitation, price) governed by amendments to Schedules A, B, and C as applicable. 
  

	 13.9
	 Notices. 



Any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to
the other party by personal delivery, by telecopy, facsimile communication, or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses, telecopy or facsimile numbers or electronic mail
addresses set forth below: 
  
 ***Confidential Treatment Requested 

  
 - 30 - 








 Standard Form (PPI, April 2, 2010) 

 
  

If to Client: 
  

● 

Attention:  ● 

Telecopier No.:  ● 

Email address: 

If to Patheon: 

Patheon Pharmaceuticals Inc. 

2110 East Galbraith Road 

Cincinnati, OH 45237-1625 

Attention. Director of Legal Services 

Telecopier No 513-948-6927 

Email address: [Frank.McCune@patheon.com] 

With a copy to: 

Patheon Inc. 
 4721
Emperor Boulevard 
 Research Triangle Park, 

NC 27703 

Attention: General Counsel 

Telecopier No.: 919-474-2269 

Email address: [Doaa.Fathallah@patheon.com] 

or to any other addresses, telecopy or facsimile numbers or electronic mail addresses given to the other party in accordance with the terms of this
Section 13.9. Notices or written communications made or given by personal delivery, telecopy, facsimile, or electronic mail will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after
being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner. 
  

	 13.10
	 Severability. 



If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any
respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions hereof, because each provision is separate, severable, and distinct. 

 

	 13.11
	 Entire Agreement. 



This Agreement, together with the Quality Agreement and the Confidentiality Agreement, constitutes the full, complete, final and
integrated agreement between the parties 

  
 - 31 - 








 Standard Form (PPI, April 2, 2010) 

 
  

relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings
concerning the subject matter hereof. Any modification, amendment, or supplement to this Agreement must be in writing and signed by authorized representatives of both parties. In case of conflict, the prevailing order of documents will be this
Agreement, the Quality Agreement, and the Confidentiality Agreement. 
  

	 13.12
	 Other Terms. 



No terms, provisions or conditions of any purchase order or other business form or written authorization used by Client or Patheon will
have any effect on the rights, duties, or obligations of the parties under or otherwise modify this Agreement, regardless of any failure of Client or Patheon to object to the terms, provisions, or conditions unless the document specifically refers
to this Agreement and is signed by both parties. 
  

	 13.13
	 No Third Party Benefit or Right. 



For greater certainty, nothing in this Agreement will confer or be construed as conferring on any third party any benefit or the right
to enforce any express or implied term of this Agreement. 
  

	 13.14
	 Execution in Counterparts. 



This Agreement may be executed in two or more counterparts, by original or facsimile signature, each of which will be deemed an
original, but all of which together will constitute one and the same instrument. 
  

	 13.15
	 Use of Client Name. 



Patheon will not make any use of Client’s name, trademarks or logo or any variations thereof, alone or with any other word or
words, without the prior written consent of Client, which consent will not be unreasonably withheld. Despite this, Client agrees that Patheon may include Client’s name and logo in customer lists or related marketing and promotional material for
the purpose of identifying users of Patheon’s Manufacturing Services. 
  

	 13.16
	 Governing Law. 



This Agreement will be construed and enforced in accordance with the laws of the State of Ohio and the laws of the United States of
America applicable therein and subject to the exclusive jurisdiction of the courts thereof. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement. 

  
 - 32 - 








 Standard Form (PPI, April 2, 2010) 

 
  

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the date first written above.

  

			
	 PATHEON PHARMACEUTICALS INC.

 

	 By:
	 	 /s/ Eric Evans

	 Name:
	 	 Eric Evans

	 Title:
	 	 Chief Financial Officer




 

			
	 RAPTOR THERAPEUTICS, INC.

 

	 By:
	 	 /s/ Thomas E. Daley

	 Name:
	 	 Thomas E. Daley

	 Title:
	 	 President




  
 - 33 - 








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE A 
 PRODUCT LIST AND
SPECIFICATIONS 
 [...***...] 
  

***Confidential Treatment Requested 

  








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE B 
 MINIMUM RUN QUANTITY,
ANNUAL VOLUME, AND PRICE 
 [...***...] 
  

***Confidential Treatment Requested 

  








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE C 
 ANNUAL STABILITY
TESTING 
 [...***...] 
  

***Confidential Treatment Requested 

  








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE D 
 [...***...] 

 
 ***Confidential Treatment Requested 

  








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE E 
 TECHNICAL DISPUTE
RESOLUTION 
 Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in
the following manner 
 1.        Appointment of Expert. Within [...***...] after a party
requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the parties are unable
to so agree within the [...***...] period, or in the event of disclosure of a conflict by an expert under Paragraph 2 hereof which results in the parties not confirming the appointment of the expert, then an expert (willing to act in that
capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association 

2.        Conflicts of Interest. Any person appointed as an expert will be entitled to act and
continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment
(or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the parties will, after the disclosure, have confirmed his appointment. 

3.        Not Arbitrator. No expert will be deemed to be an arbitrator and the provisions of the
American Arbitration Act or of any other applicable statute (foreign or domestic) and the law relating to arbitration will not apply to the expert or the expert’s determination or the procedure by which the expert reaches his determination
under this Schedule E. 
 4.        Procedure. Where an expert is appointed 

 

	 	 (a)
	 Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place
for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his
decision (with full reasons) within [...***...] (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof. 



 

	 	 (b)
	 Disclosure of Evidence. The parties undertake one to the other to give to any expert all the evidence and
information within their respective possession or control as the expert may reasonably consider necessary for determining the matter before him which they will disclose promptly and in any event within [...***...] of a written request from the
relevant expert to do so. 


  

	 	 (c)
	 Advisors. Each party may appoint any counsel, consultants and advisors as it feels appropriate to assist the
expert in his determination and so as to present their respective cases so that at all times the parties will co-operate and seek to narrow and limit the issues to be determined. 



 

	 	 (d)
	 Appointment of New Expert. If within the time specified in Paragraph 4(a) above the expert will not have rendered
a decision in accordance with his appointment, 



  
 ***Confidential Treatment
Requested 








 Standard Form (PPI, April 2, 2010) 

 
  

	 	a new expert may (at the request of either party) be appointed and the appointment of the existing expert will thereupon cease for the purposes of determining the matter at issue between the parties save this if the
existing expert renders his decision with full reasons prior to the appointment of the new expert, then this decision will have effect and the proposed appointment of the new expert will be withdrawn. 


 

	 	 (e)
	 Final and Binding. The determination of the expert will, except for fraud or manifest error be final and binding
upon the parties. 


  

	 	 (f)
	 Costs. Each party will bear its own costs for any matter referred to an expert hereunder and, in the absence of
express provision in the Agreement to the contrary, the costs and expenses of the expert will be shared equally by the parties. 



For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself
indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including this Schedule E) will remove or limit the authority of the relevant qualified person (as specified by the
Quality Agreement) to determine whether the Products are to be released for sale or distribution. 

  
 - 2 - 








 Standard Form (PPI, April 2, 2010) 

 
  

SCHEDULE F 
 COMMERCIAL QUALITY
AGREEMENT 
  

  









			
	 




	 	 
	 	

  
 QUALITY
AGREEMENT 
 Commercial Product 

Between 
 Raptor Therapeutics Inc. 

9 Commercial Blvd., Suite 200 Novato, CA 94949 
 a
corporation existing under the laws of Delaware(“Client”) 
 -and- 

PATHEON PHARMACEUTICALS INC., 

a corporation existing under the laws of Delaware, 

Specific sites covered by this Agreement: 
 2110 E.
Galbraith Rd. Cincinnati OH 45237-1625 
 (“Patheon”) 

Effective Date: 
 Version: QG01-05-T001-01 

  
 - 2 - 









			
	 




	 	 
	 	

  
 TABLE OF CONTENTS 

 

							
	 Section 1:
	  	 BACKGROUND AND AGREEMENT
	  	 	3	 
			
	 Section 2:
	  	 RESPONSIBILITIES TABLE
	  	 	4	 
			
	 Section 3:
	  	 GENERAL
	  	 	6	 
			
	 Section 4:
	  	 DESCRIPTION OF RESPONSIBILITIES
	  	 	7	 
			
	 Section 5:
	  	 APPENDICES
	  	 	18	 

  

			
	 APPENDIX A:
	  	 PRODUCT(S)

		
	 APPENDIX B:
	  	 QUALITY CONTACTS

		
	 APPENDIX C:
	  	 PATHEON APPROVED VENDOR LIST

		
	 APPENDIX D:
	  	 CLIENT APPROVED VENDOR LIST

		
	 APPENDIX E:
	  	 PATHEON APPROVED CONTRACT LABORATORIES LIST

		  	


  
  

					
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 SECTION 1: BACKGROUND AND
AGREEMENT 
 BACKGROUND. Under a manufacturing services agreement (“MSA”) that will be effective
November 15, 2010 between Patheon and the Client, Patheon agreed to perform pharmaceutical manufacturing services (“Manufacturing Services”) for certain Products (as described in Appendix A hereto) and the Client is required to
give certain information (“Specifications”) to Patheon in order for Patheon to perform the Manufacturing Services. Under the MSA, Patheon is required to operate within the Specifications. The parties desire to allocate the responsibility
for procedures and Specifications impacting on the identity, strength, quality, and purity of the Products. 

AGREEMENT. NOW THEREFORE in consideration of rights conferred and the obligations assumed under the MSA and herein, and
for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound, the parties agree as follows: 

  
  

					
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SECTION 2: RESPONSIBILITIES TABLE 

Patheon will be responsible for all the operations that are marked with “X” in the column titled “Patheon” and the Client will be
responsible for all the operations that are marked with “X” in the column titled “Client”. If marked with “(X)”, cooperation is required from the designated party. 

 

							
	Section
No.	  	 Subject /
Terms
	  	    Client    	  	    Patheon    
	
4.1 Quality Management

	4.1.1	  	 GMP,
Health and Safety Compliance
	  	X	  	X
	4.1.2	  	 Client
Audit Rights
	  	X	  	 
	4.1.3	  	
Subcontracting
	  	 	  	X
	4.1.4	  	
Self-Inspection
	  	 	  	X
	
4.2 Regulatory Requirements

	4.2.1	  	
Permits
	  	X	  	X
	4.2.2	  	 Regulatory
Filing / Registration Change Control
	  	X	  	(X)
	4.2.3	  	 Regulatory
Compliance
	  	 	  	X
	4.2.4	  	 Government
Agency Inspections, Communications and Requisitions
	  	(X)	  	X
	
4.3 Material Control

	4.3.1	  	 Test
Methods and Specifications
	  	X	  	 
	4.3.2	  	 Material
Destruction
	  	(X)	  	X
	4.3.3	  	 Vendor
Audit Responsibility
	  	X	  	X
	4.3.4	  	 Client
Furnished Materials
	  	X	  	 
	4.3.5	  	 Incoming
Material Release
	  	 	  	X
	
4.4 Building, Facilities, Utilities and Equipment

	4.4.1	  	
General
	  	 	  	X
	4.4.2	  	 Equipment,
Calibration and Preventative Maintenance
	  	 	  	X
	4.4.3	  	
Environmental Monitoring Program
	  	 	  	 
	
4.5 Product Controls

	4.5.1	  	 Master
Batch Record
	  	(X)	  	X
	4.5.2	  	
Reprocessing and Rework
	  	(X)	  	X
	4.5.3	  	 Personnel
Training
	  	 	  	X
	
4.6 Packaging, Labeling and Printed Materials

	4.6.1	  	 Master
Batch Packaging Records
	  	(X)	  	X
	4.6.2	  	 Content of
Printed Material and Artwork
	  	X	  	 
	4.6.3	  	 Test
Methods and Method Validation
	  	(X)	  	X
	
4.7 Exception Reports (Deviations / Investigations)

	4.7.1	  	
Manufacturing Instruction Deviations
	  	 	  	X
	4.7.2	  	 Packaging
Instructions Deviations
	  	 	  	X
	4.7.3	  	
Notification of Deviations
	  	 	  	X


  
  

					
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4.8 Release of Product

	4.8.1	  	 Test
Methods and Specifications
	    	        X        	    	        X        
	4.8.2	  	 Batch
Release for Shipment
	    	 	    	X
	4.8.3	  	
Certificate of Compliance
	    	 	    	X
	4.8.4	  	 Product
Release
	    	X	    	 
	
4.9 Validation

	4.9.1	  	 Master
Validation Plan
	    	(X)	    	X
	4.9.2	  	 Cleaning
Validation Program
	    	(X)	    	X
	4.9.3	  	 Analytical
Method and Procedure Validation
	    	X	    	(X)
	
4.10 Change Control

	4.10.1	  	
General
	    	X	    	X
	
4.11 Documentation

	4.11.1	  	 Record
Retention
	    	 	    	X
	4.11.2	  	 Batch
Document Requisition
	    	 	    	X
	
4.12 Laboratory Controls

	4.12.1	  	
Specifications and Test Methods
	    	X	    	X
	4.12.2	  	 Out of
Specifications (OOS) / Out of Trend (OOT)
	    	 	    	X
	
4.13 Stability

	4.13.1	  	 Sample
Storage
	    	 	    	X
	4.13.2	  	 Stability
Studies and Protocol
	    	X	    	X
	4.13.3	  	 Stability
Failures
	    	 	    	X
	4.13.4	  	
Termination of MSA
	    	 	    	X
	
4.14 Annual Product Review

	4.14.1	  	
General
	    	 	    	 
	
4.15 Storage and Distribution

	4.15.1	  	
General
	    	 	    	X
	4.15.2	  	 Product
Storage and Shipment Changes
	    	(X)	    	X
	4.15.3	  	 Product
Quarantine
	    	 	    	X
	
4.16 Product Complaints

	4.16.1	  	 Complaint
Investigation
	    	 	    	 
	
4.17 Product Recall

	4.17.1	  	 Product
Recall Notification
	    	X	    	(X)
	4.17.2	  	 Government
Agency Notification
	    	X	    	(X)
	
4.18 Reference and Retention Samples

	4.18.1	  	 Excipient
and Active Ingredient Reference Sample
	    	 	    	X
	4.18.2	  	 Finished
Product Retention Sample
	    	X	    	X


  
  

					
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 SECTION 3: GENERAL 

 

			
	 3.1
	  	 Any communications about the subject matter of this Agreement will be directed, in the first instance, to the person(s) identified
in Appendix B.

		
	 3.2
	  	 Capitalized terms not otherwise defined herein will have the meaning specified in the MSA.

		
	 3.3
	  	 If any provision of this Agreement should be or found invalid, or unenforceable by law, the rest of the Agreement will remain
valid and binding and the parties will negotiate a valid provision which meets as close as possible the objective of the invalid provision.

		
	 3.4
	  	 If this Agreement requires modification so that the party affected cannot be reasonably expected to continue to perform under this
Agreement, then the parties will negotiate and revise the Agreement accordingly.

		
	 3.5
	  	 Any amendment of this Agreement will be made in writing and signed by both parties.

		
	 3.6
	  	 This Agreement will start on the Effective Date that is set forth on the cover page of this Agreement and will remain valid until
all Quality obligations under all applicable MSAs have been fulfilled.

		
	 3.7
	  	 If there is any conflict between the terms of this Agreement and the MSA, the MSA will control except for any specific quality
issue.

		
	 3.8
	  	 The “Background” provisions of Section 1 are incorporated into this Agreement.



  
  

					
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 SECTION 4: DESCRIPTION OF
RESPONSIBILITIES 
  

			
	 4.1
	  	 QUALITY MANAGEMENT

		
	 4.1.1
	  	 GMP, Health and Safety Compliance

		  	 Patheon will conduct operations in compliance with applicable environmental, occupational health and safety laws, and cGMP
regulations.

		
	 4.1.2
	  	 Client Audit Rights

		  	 Patheon will permit audits by the Client, on reasonable prior written notice, of all relevant premises, procedures, and
documentation that relate to Client’s Product. Client audits are limited to one audit per calendar year unless for cause.

		
	 4.1.3
	  	 Subcontracting

		  	 Patheon will not subcontract tasks to a third party without Client’s consent. Patheon may subcontract raw material testing to
other Patheon facilities and to other qualified third party laboratories.

		
	 4.1.4
	  	 Self-Inspection

		  	 Patheon will perform self-inspections of its premises, facilities, and processes used to manufacture, package, test, and store the
Client’s starting, intermediate, and/or finished products in accordance with Patheon’s written standard operating procedures (“SOPs”) to ensure compliance with cGMP and this Agreement.

		
	 4.2
	  	 REGULATORY REQUIREMENTS

		
	 4.2.1
	  	 Permits

		  	 The Client will be solely responsible for obtaining or maintaining, on a timely basis, any permits or other regulatory approvals for
the Products or the Specifications, including, without limitation, all marketing and post-marketing approvals.

		
		  	 Patheon will obtain and maintain the appropriate manufacturing license(s) to allow for the Manufacturing Services.

		
	 4.2.2
	  	 Regulatory Filing / Registration Change Control

		  	 The Client will determine whether changes to the Product or related to the Product will impact a regulatory filing and will apply for
and receive approval for any required manufacturing amendment, change or addition to their Product marketing authorization. Upon request, Patheon will assist in the preparation and review of pertinent sections of new or supplemental regulatory
applications before filing. The Client will give Patheon copies of sections of product registration/regulatory submissions that are relevant to



  
  

					
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		  	 the manufacture of the Product. The Client is responsible for all communications with Regulatory Authorities as well as for the
approval, maintenance, and updating of marketing approval in a timely manner.

		
	 4.2.3
	  	 Regulatory Compliance

		  	 Patheon will ensure that Product(s) are manufactured and tested in strict compliance with current US Federal and EC regulatory and
statutory requirements relating to Good Manufacturing Practices (GMP) (US 21 CFR parts 21O and 211 and EU Directive 2003/94/EC for the manufacture of finished medicinal product) as applicable, regulatory approvals and local laws and regulations
applicable at the site(s) of manufacture and/or testing.

		
	 4.2.4
	  	 Government Agency Inspections, Communication and Requisitions

		  	 Patheon will permit all relevant inspections by regulatory authorities of premises, procedures, and documentation.

		
		  	 Patheon will notify the Client within one Business Day of receipt of any notice of inspection from a regulatory authority and
within one Business Day of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. The Client reserves the right to be present on site for PRODUCT
pre-approval inspections.

		
		  	 Patheon will notify the Client within one Business Day of receipt of a Form 483s, warning letter, or the like, from any regulatory
agency that relates to the Product; or if the supply of Product will be affected, or if the facilities used to produce, test or package the Product will be affected. A redacted copy will be provided to the Client within five Business
Days.

		
		  	 The responses from Patheon related to the Product will be reviewed and approved by the Client before submission to the regulatory
agency. But Patheon reserves the right to respond to the regulatory agency without approval, if, in the reasonable opinion of Patheon’s Legal counsel, it is required to do so.

		
	 4.3
	  	 MATERIAL CONTROL

		
	 4.3.1
	  	 Test Methods and Specifications

		  	 The Client will give Patheon a copy of the Specifications and test methods used if the Client issues raw material
Specifications.

		
	 4.3.2
	  	 Material Destruction

		  	 Patheon has the right to either return to the Client or dispose of any outdated or rejected material. If the material is disposed of,
disposal will be consistent with the nature of the material and sent to a permitted waste



  
  

					
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		  	 disposal facility. Before disposal:

		
	(i.)	  	 Patheon will send notice to the Client of Patheon’s intent to dispose of the material. If no direction is received from the
Client, Patheon will dispose of the material no sooner than 90 days after the date of the notice.

		
	(ii.)	  	 The materials will be disposed and destroyed in compliance with local environmental regulations and performed in a secure and legal
manner that prevent unauthorized use or diversion.

		
		  	 Patheon will maintain destruction records in accordance with Patheon SOPs.

		
	 4.3.3
	  	 Vendor Audit Responsibility

		
	 4.3.3.1
	  	     Excipient and API Vendors:

	(i.)	  	 If the Client stipulates an excipient or API vendor, the Client will audit and approve the vendor and ensure cGMP compliance in
accordance with Section 4.3.4 of this Agreement. The Client stipulated vendor(s) will be included on the Client’s approved vendor list (Appendix D).

		
	(ii.)	  	 If Patheon stipulates the excipient vendor, Patheon will audit and approve the vendor and ensure cGMP compliance in accordance with
Patheon’s SOPs. The Patheon stipulated vendor(s) will be included on Patheon’s approved vendor list (Appendix C).

		
	 4.3.3.2
	  	     Packaging Component Vendors:

	(i.)	  	 If the Client stipulates a packaging component vendor, the Client will audit and approve the manufacturer and ensure cGMP compliance.
The Client stipulated vendor(s) will be included on the approved vendor list (Appendix D).

		
	(ii.)	  	 If Patheon stipulates the packaging component vendor, Patheon will audit and approve the vendor and ensure cGMP compliance in
accordance with Patheon’s SOP. The Patheon stipulated vendor(s) will be included on the approved supplier list (Appendix C).

		
	 4.3.4
	  	 Client Furnished Materials

		  	 The Client is responsible for vendor qualification of Client furnished materials and for providing a certificate of compliance
confirming the following:

		
		  	 (i.)    That the materials are compliant with the provisions outlined in
the “Note for Guidance on minimizing the risk of transmitting spongiform



  
  

					
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		  	         encephalopathy agents via human and
veterinary medicinal products” (EMEA/410/01 , Rev.2 or update); and

		
		  	 (ii.)   A residual solvent certificate confirming that there is no potential
for specific toxic solvents listed in the EP / USP / ICH residual solvents Class I, Class II or Class Ill to be present and the material, if tested, will comply with established IEP / USP / ICH requirements. If any of the solvents
listed in the EP / USP / ICH residual solvents Class I, Class II or Class Ill are used in the manufacture or are generated in the manufacturing process, solvents of concern will be indicated.

		
	4.3.5	  	 In-Coming Material Release

		  	 Before its use in the manufacture of any Product, all material(s) will be inspected, tested, and released by Patheon against the
Specification approved by the Client.

		
	 4.4
	  	 BUILDING, FACILITIES, UTILITIES , AND
EQUIPMENT

		
	4.4.1	  	 General

		  	 All buildings and facilities used in the manufacturing, packaging, testing and storage of any materials and/or Product will be of
suitable size, construction and location to facilitate cleaning, and will be maintained in a good state of repair. Maintenance and cleaning records will be kept in accordance with Patheon SOPs.

		
	4.4.2	  	 Equipment, Calibration and Preventative Maintenance

		  	 All equipment used in the manufacturing, packaging, testing, and storage of any materials and/or Product will be suitable for its
intended use and appropriately located to allow for cleaning and maintenance. Calibration and maintenance records will be kept according to Patheon SOPs for all critical equipment. Patheon will calibrate instrumentation and qualify computer systems
and all equipment used in the manufacture and testing of the Product in accordance with Patheon SOPs.

		
	4.4.3	  	 Environmental Monitoring Program

		  	 Patheon will perform and maintain an environmental monitoring program. The collected data will be reviewed and interpreted by the
responsible person within Patheon’s quality unit. Any out of limit results will be managed appropriately in accordance with Patheon SOPs.

		
	 4.5
	  	 PRODUCTION CONTROLS

		
	4.5.1	  	 Master Batch Record



  
  

					
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		  	 The Client will give Patheon the Specifications and Patheon will manufacture Product in accordance with the
Specifications.

		
		  	 Patheon is responsible for preparing the master batch records for the Product. The Client is responsible for reviewing and approving
the master batch records before the manufacture of the Product.

		
		  	 Patheon will not make changes to master batch records except through the established Patheon change control system, and all master
document revisions will be approved by the Client’s quality unit. Any changes made to issued batch records (before master revisions) must be reviewed and approved by the Client’s quality unit before implementation unless otherwise agreed
to in writing.

		
	 4.5.2
	  	 Reprocessing and Rework

		  	 Patheon will not reprocess or rework the Product without the prior written consent from the Client.

		
		  	 Reprocessing is defined as the introduction of material back into the process and repeating a step, (e.g. redrying, remilling) using
the same equipment and techniques of the established manufacturing process.

		
		  	 Rework is defined as the introduction of material to one or more processing steps that are different from the established
manufacturing process.

		
	 4.5.3
	  	 Personnel Training

		  	 Patheon will give appropriate training to its employees. Each person engaged in the manufacture, packaging, testing, storage, and
shipping of the Product will have the education, training, and experience necessary, consistent with current GMP and safety training requirements.

		
	 4.6
	  	 PACKAGING, LABELING AND PRINTED
MATERIALS

		
	 4.6.1
	  	 Master Batch Packaging Records

		  	 The Client will approve the Specifications for all packaging components. Patheon will create, control, issue, and execute in
accordance with the master batch packaging record and the Specifications.

		
		  	 Patheon will not make changes to master batch packaging records except through the established Patheon change control system, and all
master document revisions will be approved by the Client’s quality unit. Any changes made to issued batch records (before Master revisions) must be reviewed and approved by the Client’s quality unit before implementation unless otherwise
agreed to in writing.

	 4.6.2
	  	 Printed Material and Artwork



  
  

					
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		  	 The Client will give Patheon the Specifications for artwork and labelling text (blister, carton, leaflet, label etc.). The labelling
proofs must be reviewed and approved by the Client.

		
	 4.6.3
	  	 Test Methods and Method Validation

		  	 The Client will give Patheon the test methods and method validation for packaging components. Where applicable, Patheon will provide
test methods and validation for packaging components purchased from vendors on the Patheon approved vendor list only (Appendix C).

		
	 4.7
	  	 EXCEPTION REPORTS (DEVIATIONS / INVESTIGATIONS)

		
	 4.7.1
	  	 Manufacturing Instruction Deviations

		  	 Patheon will document, investigate, and resolve deviations from approved manufacturing instructions or Specifications in accordance
with Patheon’s SOPs. Patheon will report and obtain approval from the Client’s responsible person for deviation report (“DR”) type deviations where there is a potential to affect Product quality. This Client approval will
not be unreasonably withheld. Patheon will give the Client copies of all DR’s as part of the executed batch record.

		
	 4.7.2
	  	 Packaging Instructions Deviations

		  	 Patheon will document, investigate, and resolve any deviation from approved packaging instructions or Specifications according
to Patheon SOPs. Patheon will report and obtain approval from the Client’s responsible person for DR type deviations where there is a potential to affect Product quality. This Client approval will not be unreasonably withheld. Patheon will give
the Client copies of all DRs as part of the executed batch packaging record.

		
	 4.7.3
	  	 Notification of Deviations

		  	 Patheon will notify the Client within one Business Day if any significant deviation occurs during manufacture, testing or storage of
the Product, where the deviation affects the quality, efficacy or availability of the Product.

		
	 4.8
	  	 RELEASE OF PRODUCT

		
	 4.8.1
	  	 Test Methods and Specifications

		  	 The Client will give Patheon the finished Product Specifications . Patheon will validate the test methods used with assistance from
the Client.

		
	 4.8.2
	  	 Batch Release for Shipment



  
  

					
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		  	 Batch review and release for shipment to the Client will be the responsibility of Patheon’s Quality Assurance department who
will act in accordance with Patheon’s SOPs.

		
	 4.8.3
	  	 Batch release documentation

		  	 For each batch released by Patheon for shipment to the Client, the following documentation will be provided.

		
		  	 •      Copy of the executed Batch Record

		
		  	 •      Copy of the executed Packaging
Record

		
		  	 •      Certificate of Analysis (CoA)

		
		  	 •      Certificate of Manufacturing (CoM)*

		
		  	 •      Copy of any Critical or Major deviations. Minor
deviations will be noted on the CoM and available upon request.

		
		  	 *CoC or CoM to include a statement that the batch has been manufactured in accordance with cGMPs and the
Specifications.

		
	 4.8.4
	  	 Product Release

		  	 The Client will have sole responsibility for release of the Product to the market. When Patheon qualified person
(“QP”) services are employed, Patheon QP may release the Product for distribution on behalf of the Client.

		
	 4.9
	  	 VALIDATION

		
	 4.9.1
	  	 Master Validation Plan

		  	 Patheon will establish applicable master validation plans and maintain a validation program for the Product. The Client will review
and approve the master validation plan, performance qualification and process validation protocols and reports for the Product.

		
	 4.9.2
	  	 Cleaning Validation Program

		  	 The Client will give Patheon the toxicological information to be used in the development of a cleaning program. Patheon will maintain
an appropriate cleaning and cleaning validation program.

		
	 4.9.3
	  	 Analytical Method and Procedure Validation

		  	 The Client must ensure that its analytical methods and manufacturing procedures (including packaging procedures) are validated. If
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	 4.10
	  	 CHANGE CONTROL

		
	 4.10.1
	  	 General

		  	 Patheon will notify and obtain approval from the Client before implementing any proposed changes to the process, materials, testing,
equipment or premises, where the changes may directly affect the Product or regulatory submission. This Client approval will not to be unreasonably withheld.

		
		  	 The Client will be responsible for determining whether or not to initiate registration variation procedures and for maintaining
adequate control over the quality commitments of the marketing authorization made to the regulatory authorities by the Client for the Products.

		
		  	 Following validation of a process change, Patheon will deliver a copy of the related validation report to the Client and the
associated stability data, if applicable, as it becomes available.

		
	 4.11
	  	 DOCUMENTATION

		
	 4.11.1
	  	 Record Retention

		  	 Patheon will maintain all batch records for a minimum of one year past Product expiry date and supply all these records to the Client
upon request.

		
		  	 Patheon will maintain records and evidence on the testing of raw materials and packaging/labeling materials for five years after the
materials were last used in the manufacture or packaging/labeling of the Product.

		
		  	 At the end of the above noted retention period, the Client will be contacted concerning the future storage or destruction of the
documents.

		
	 4.11.2
	  	 Batch Document Requisition

		  	 At the request of the Client, Patheon will give the Client a copy of any of the executed batch documents relating to Products within
five Business Days of the request.

		
	 4.12
	  	 LABORATORY CONTROLS

		
	 4.12.1
	  	 Specifications and Test Methods

		  	 Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved
Specifications, analytical methods, and Patheon’s SOPs.



  
  

					
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		  	 The Client will give Patheon the Active Material Specifications including a CoA.

		
		  	 The Client will give Patheon the test methods for Active Material (if non -compendial). The Client is responsible for validating
non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development at Client’s cost.

		
	 4.12.2
	  	 Out of Specifications (OOS) / Out of Trend (OOT)

		  	 Patheon will notify Client’s quality unit of confirmed
out-of-Specification (“OOS”) or out-of-trend (“OOT”)
results within one Business Day. Patheon will generate a DR type deviation as per Patheon SOPs and obtain approval of the DR from the Client’s responsible person within their quality unit. This Client approval will not be unreasonably
withheld.

		
	 4.13
	  	 STABILITY 

		
	 4.13.1
	  	 Sample Storage

		  	 Patheon will store stability samples as required.

		
	 4.13.2
	  	 Stability Studies and Protocol

		  	 The Client will develop and validate stability indicating assay(s) before process validation. If required, Patheon may assist at
Client’s cost.

		
		  	 If applicable, Patheon will conduct stability studies in accordance with the agreed and validated stability testing analytical
methods at the agreed upon testing points in accordance with the approved stability protocol.

		
		  	 Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and the Client. Patheon will
give the Client the stability data on an ongoing basis as agreed to by both parties.

		
	 4.13.3
	  	 Stability Failures

		  	 Patheon will notify the Client of any stability failure for Product supplied to the Client within two Business Days If a result
indicates that a Product has failed to remain within stability Specifications, Patheon will notify the Client within one Business Day.

		
	 4.13.4
	  	 Termination of MSA

		  	 If the MSA is terminated, Patheon will continue to give the Client the stability data supporting the acceptability of the Product
until all Product distributed by the Client has reached the end of its shelf-life.

		
	 4.14
	  	 ANNUAL PRODUCT REVIEW



  
  

					
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	 4.14.1
	  	 General

		  	 The Client will complete the annual product review in accordance with regulatory requirements of the Product marketed authorization.
Patheon will give the Client copies of all information and correspondence necessary to support the annual product reviews upon request..

		
	 4.15
	  	 STORAGE AND DISTRIBUTION

		
	 4.15.1
	  	 General

		  	 Patheon will ship Product in accordance with the agreed qualified transportation requirements provided by the Client to
Patheon.

		
	 4.15.2
	  	 Product Storage and Shipment Changes

	 .
	  	 Patheon will communicate any proposed changes in storage or shipping to the Client for review and approval. The Client approval will
not be unreasonably withheld.

		
	 4.15.3
	  	 Product Quarantine

		  	 Patheon will have a system in place for assuring that unreleased Product is not shipped unless authorized by the Client’s
quality unit.

		
	 4.16
	  	 PRODUCT COMPLAINTS

		
	 4.16.1
	  	 Complaint Investigation

		  	 The Client will investigate and resolve all medical and non-medical Product complaints.
Patheon will investigate all Patheon manufacturing and packaging-type Product complaints related to the Manufacturing Services. The Client will retrieve complaint sample(s) and forward them to Patheon in a timely manner to aid a complete and
comprehensive investigation.

		
	 4.17
	  	 PRODUCT RECALL

		
	 4.17.1
	  	 Product Recall Notification

		  	 The Client will notify Patheon about a Product recall or other regulatory type product notification (e.g. field alert) as soon as
possible, but, in any event, before informing the appropriate regulatory authorities. The Client will be responsible for all related recall activities.

		
	 4.17.2
	  	 Government Agency Notification

		  	 The Client will perform the Product recall and will inform the appropriate regulatory authorities. Where legislated, Patheon reserves
the right to



  
  

					
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	  	 Page16of18        











			
	 




	 	 
	 	

  

			
		  	 notify regulatory authorities of Product quality issues. Patheon will inform the Client before notifying the regulatory
authorities.

		
	 4.18
	  	 REFERENCE AND RETENTION SAMPLES

		
	 4.18.1
	  	 Excipient and Active Ingredient Reference Sample

		  	 Patheon will keep a reference sample of each material received by Patheon and used to manufacture the Product. The reference sample
will consist of at least two times the necessary quantity for all Quality Control tests required to determine whether the materials meet required Specifications.

		
		  	 The reference samples will be stored by Patheon under controlled conditions in accordance with GMP storage requirements for one year
beyond the expiration date of the last batch of the product containing the materials. The reference samples will be made available by Patheon to the Client, if requested

		
	 4.18.2
	  	 Finished Product Retention Sample

		  	 Retention samples of finished Product will be retained by Patheon for one year past Product expiry or for a longer period as required
by law. Where applicable, the legal sample(s) of finished Product must be retained by the Client.


 *    *    * 

IN WITNESS WHEREOF, the parties have caused their duly authorized officer to execute and deliver this Quality Agreement as of the Effective Date
identified on the first page: 
 RAPTOR THERAPEUTICS INC. 

 

			
	
By:                        
                                         
     
	  	
Date:                        
                              

	Erica Kraynack	  	
	Director, Program Management	  	
		
	 PATHEON PHARMACEUTICALS
INC.
	  	
		
	
By:                        
                                         
     
	  	
Date:                        
                              

	David J. Leuck	  	
	Quality Operations Director	  	


  
  

					
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	  	 Page17of18        











			
	 




	 	 
	 	

  
 SECTION 5: APPENDICES

  

	 	 •
	 	 Appendix A: Product(s) 


  

	 	 •
	 	 Appendix B: Quality Contacts 



 

	 	 •
	 	 Appendix C: Patheon Approved Supplier List 



 

	 	 •
	 	 Appendix D: Client Approved Supplier List 



 

	 	 •
	 	 Appendix E: Patheon Approved Contract Laboratories List 



  
  

					
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	  	 Page18of18        










 Standard Form (PPI, April 2, 2010) 

 
  
  

SCHEDULE G (Reserved) 

  








 Standard Form (PPI, April 2, 2010) 

 
  
  

SCHEDULE H 
 QUARTERLY ACTIVE
MATERIALS INVENTORY REPORT 
 [...***...] 

  
 ***Confidential Treatment
Requested 








 Standard Form (PPI, April 2, 2010) 

 
  
  

SCHEDULE I 
 REPORT OF ANNUAL
ACTIVE MATERIALS INVENTORY RECONCILIATION 
 AND CALCULATION OF ACTUAL ANNUAL YIELD 

[...***...] 

  
 ***Confidential Treatment
Requested 








 Standard Form (PPI, April 2, 2010) 

 
  
  

SCHEDULE J (Reserved) 

  








 Amendment to Manufacturing Services Agreement 

between Patheon Pharmaceuticals Inc., and Raptor Therapeutics, Inc. 

Background: Patheon Pharmaceuticals Inc., (“Patheon”) and Raptor Therapeutics, Inc.,
(“Raptor”) entered into a Manufacturing Services Agreement dated November 15, 2010 (the “Agreement”). Patheon and Raptor wish to amend the Agreement to revise Schedule B. 

NOW THEREFORE in consideration of the premises hereof and other good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged by the parties, the parties agree to amend the Agreement as follows: 
  

	 1.
	 Amendment to Agreement: 



Schedule B to the Agreement is deleted in its entirety and is replaced with a new Schedule B as attached to this Amendment.

  

	 2.
	 No Other Modifications. The “Background” section of this document is incorporated into
the Amendment. Except as modified by this Amendment, the terms and conditions of the Agreement remain unchanged. 


 IN
WITNESS WHEREOF, the parties have caused this Amendment to be duly executed by their authorized representatives, effective as of April 5, 2012. 
  

									
	 RAPTOR THERAPEUTICS, INC.
	 		 	 PATHEON PHARMACEUTICALS INC.

					
	 By:
	 	 /s/ Thomas E. Daley
	 		 	 By:
	 	 /s/ Francis P. McCune

	 Name:
	 	 Thomas E. Daley
	 		 	 Name:
	 	 Francis P. McCune

	 Title:
	 	 President
	 		 	 Title:
	 	 Secretary

					
		 		 		 		 	 APPROVED BY LEGAL

					
		 		 		 		 	
FPM    
4-13-12

		 		 		 		 	 Initials Date



  
 1 








 SCHEDULE B 

(as revised by the Amendment to the Agreement effective April 5, 2012) 

MINIMUM RUN QUANTITY, ANNUAL VOLUME, AND PRICE 

[...***...] 
  

***Confidential Treatment Requested 

  
 2 








 Second Amendment to Manufacturing Services Agreement 

between Patheon Pharmaceuticals Inc., and Raptor Pharmaceuticals Inc. 

Background: Patheon Pharmaceuticals Inc., (“Patheon”) and Raptor Pharmaceuticals Inc., (formerly known
as Raptor Therapeutics, Inc.), (“Raptor”) entered into a Manufacturing Services Agreement dated November 15, 2010, as amended on April 5, 2012 (the “Agreement”). Patheon and Raptor wish to further amend
the Agreement to add Raptor Pharmaceuticals Europe B.V., a wholly owned subsidiary of RPTP European Holdings C.V. (a wholly-owned subsidiary of Raptor) as an additional party to the Agreement and to update the Pricing in Schedule B. 

NOW THEREFORE in consideration of the premises hereof and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged by the parties, the parties agree to amend the Agreement as follows: 
  

	 1.
	 Second Amendment to Agreement: 



(a) Raptor Pharmaceuticals Europe B.V. located at Naritaweg 165, Telestone-Teleport, 1043 BW Amsterdam, the
Netherlands, is hereby added as a party to the Agreement and will thereupon have all the rights and obligations of the “Client” thereunder. All references to “Client” in the Agreement shall refer to Raptor and/or Raptor
Pharmaceuticals Europe B.V., as applicable. 
 (b) Schedule B to the Agreement is deleted in its entirety and is
replaced in its entirety with the Schedule B attached to this Second Amendment. 
  

	 2.
	 No Other Modifications. The “Background” section of this document is incorporated into
this Second Amendment. Except as expressly amended by this Second Amendment, the terms and conditions of the Agreement shall remain in full force and effect. 



 

	 3.
	 Counterparts. This Second Amendment may be executed in two or more counterparts, each of which shall be
deemed an original and all of which together shall constitute one instrument. 


 [Signature page to follow] 







 IN WITNESS WHEREOF, the parties have caused this Second Amendment to be duly executed by their authorized
representatives, effective as of June 21, 2013. 
  

									
	 RAPTOR PHARIVI ACEUTICALS INC.
	 		 	 PATHEON PHARMACEUTICALS INC.

					
	 By:
	 	 /s/ Julie Smith
	 		 	 By:
	 	 /s/ Francis P. McCune

	 Name:
	 	 Julie Smith
	 		 	 Name:
	 	 Francis P. McCune

	 Title:
	 	 EVP Strategy & COO
	 		 	 Title:
	 	 Secretary

	  
 RAPTOR PHARMACEUTICALS EUROPE B.V.
	 		 	  
 APPROVED BY LEGAL

					
	 By:
	 	 /s/ Kim R. Tsuchimoto
	 		 		 	
FPM    
4-13-12

	 Name:
	 	 Kim R. Tsuchimoto
	 		 		 	 Initials Date

	 Title:
	 	 Director A
	 		 		 	
	  
 RAPTOR PHARMACEUTICALS EUROPE B.V.
	 		 	
					
	 By:
	 	 /s/ Henk Doude van Troostwijk
	 		 		 	
	 Name:
	 	 Henk Doude van Troostwijk
	 		 		 	
	 Title:
	 	 Director B
	 		 		 	








 SCHEDULE B 

(as revised by the Second Amendment to the Agreement effective June 21, 2013) 

MINIMUM ORDERING QUANTITY AND PRICE 

[...***...] 
  

 
 ***Confidential Treatment Requested