Document:

EX-10.26

 Exhibit 10.26 

Confidential Materials omitted and filed separately with the 

Securities and Exchange Commission. Double asterisks denote omissions. 

SUPPLY AGREEMENT 

Between CNJ Holdings Inc. and 

Rovi Contract Manufacturing, S.L. 

This Supply Agreement, effective as of April 29th, 2014 (the “Effective Date”), is entered by and between CNJ
Holdings Inc., doing business as Emergent BioSolutions, with an address at c/o 155 Innovation Drive, Winnipeg, Manitoba, Canada R3T 5Y3 (“Cangene”), and Rovi Contract Manufacturing, S.L., with an address at Julian Camarillo, 35,
28037 Madrid, SPAIN (“Company”). 
 WHEREAS, Cangene is interested in purchasing certain products from Company, and
Company desires to supply such products to Cangene under the terms set forth in this Agreement; 
 NOW, THEREFORE, in consideration of the
foregoing, of the mutual covenants and undertakings contained herein and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Cangene and Company, intending to be legally bound, hereby agree as
follows: 
  

	1)	Definitions: 

 a) “Act” means the U.S. Federal Food, Drug and
Cosmetic Act, as amended. 
 b) “Affiliate” means, with respect to a party, any individual, corporation or
other business entity which, either directly or indirectly, controls such party, is controlled by such party, or is under common control with such party. As used herein, “control” means possession of the power to direct, or cause the
direction of the management and policies of a corporation or other entity whether through the ownership of voting securities, by contract or otherwise. 

c) “Agreement” means this Supply Agreement, and all exhibits attached hereto including the Quality Agreement, and all
accepted Purchase Orders that expressly reference this Supply Agreement. 
 d) “Business Day” means any day
other than a day which is a Saturday, Sunday, or federal bank or federal government holiday in the United States and/or Spain. 

e) “Cangene Official Correspondent” means Vicki Wolff-Long, Vice-President and General Manager, Cangene bioPharma Inc.,
or other person designated by Cangene and noticed to Company. 
 f) “Certificate of Analysis” means a
certificate in form and substance satisfactory to Cangene, signed by an authorized employee of the Company’s Quality Department, and authenticating the pharmaceutical analysis of each batch of the Product delivered to Cangene. 

  
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 g) “Coagulation Products” means Cangene’s recombinant coagulation
products for hemophilia. 
 h) “Company Official Correspondent” means Mr. Michel GUILLORY International
Business Director or such other person designated by Company and noticed to Cangene. 
 i) “Current Good Manufacturing
Practices” or “cGMPs” means (a) all European Union (EU) applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products promulgated by any
Governmental Authority having jurisdiction over the manufacture of the Products in the form of Laws or guidance documents (including, without limitation, advisory opinions, compliance policy guides and guidelines) which guidance documents are being
implemented within the pharmaceutical manufacturing industry for such Products, and (b) the principles set forth in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211 as established by the FDA. 

j) “Dossier” means Company’s Module 2 (Quality Overall Summary) and Module 3 dossiers as well as the Drug Master File
(DMF) for the Pre-filled Syringe WFI sterile diluents described in Exhibit A, including but not limited to all documents that have been or may in the future be filed or submitted to any regulatory authority anywhere in the world. 

k) “Cangene Facility” means any Cangene location or any ordering and/or receiving facility designated by Cangene.

 l) “Governmental Authority” means any nation or government, any state, province, or other political
subdivision thereof or any entity with legal authority to exercise executive, legislative, judicial, regulatory or administrative functions or pertaining to the government in any of the relevant markets anywhere in the world. 

m) “Laws” means, with respect to the specific activity to be performed by each party under this Agreement, any and all
applicable local, municipal, provincial, federal and international laws, statutes, ordinances, rules, regulations or operating procedures now or hereafter enacted, adopted or promulgated by any Governmental Authority having jurisdiction over such
specific activity, including without limitation the United States Pharmacopeia and European Pharmacopeia 
 n)
“Product” (collectively, “Products”) means those materials to be supplied by Company to Cangene, as described in the Purchase Schedule, that meet the definitions and specifications set forth in the Quality Agreement
and the Purchase Specifications. Product that does not meet the definitions and specifications set forth in the Quality Agreement, or the Purchase Specifications, as such definitions and specifications may be amended, modified, supplemented or
superseded from time to time, whether in accordance with the terms of this Agreement or by changes or additions to cGMP or to applicable Laws, shall be referred to as “Nonconforming Product.” 

  
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 o) “Purchase Order” means any purchase order issued by Cangene in
accordance with the terms and conditions of this Agreement. 
 p) “Purchase Schedule” means the purchase
schedule containing the Products, applicable prices, and manufacturing site, the first of which is attached hereto as Exhibit A, and incorporated herein by reference. 

q) “Purchase Specifications” means, with respect to Products, any and all then-current specifications for materials,
approved suppliers, formulations, manufacturing, analytical and testing procedures, release, and other processes relating to the manufacture of the Products, as set forth in Exhibit B and in applicable Purchase Orders, as such specifications
may be amended from time to time in accordance with this Agreement. 
 r) “Quality Agreement” means that
certain Quality Agreement by and between the parties, incorporated herein as Exhibit C. 
  

	2)	Company’s Obligations; Quantity; and Orders: 

 a) General: Pursuant to the
terms and conditions of this Agreement, Company shall manufacture, supply and sell Products to Cangene or its Affiliates as ordered by Cangene or its Affiliates in the manner set forth in this Agreement. Company acknowledges and agrees that its
relationship with Cangene is on a non-exclusive basis. Without limiting the generality of the foregoing, Cangene reserves the right to qualify one or more alternate suppliers for the types of products required by Cangene to be supplied under this
Agreement. Cangene shall have the right to promote and sell (either itself or through distributors or licensees) the Products, either alone or as part of the Coagulation Products, worldwide. Likewise, Company reserves its right to promote and market
the types of products required by Cangene to be supplied under this Agreement (either itself or through distributors or licensees, either alone or as part of other products), worldwide as well as to manufacture such products for other third parties.

 b) Manufacturing: Company shall manufacture the Products consistent with the Purchase Specifications and in accordance with the
terms of the Quality Agreement (including dispute resolution provisions dealing with the conformance or nonconformance of Product), Current Good Manufacturing Practices and applicable EU Laws. In case a change in the Product specifications and/or
manufacturing process is required in order for the manufacture of the Products to be consistent with any other applicable Laws of the U.S. relating to the manufacture of such Product or as a result of a change in such applicable Laws, the terms and
conditions of the Quality Agreement shall set forth the parties’ respective roles and responsibilities in terms of identification of any such required change and the change control procedure. In any case, Cangene will assume responsibility to
identify changes required by applicable Laws of the U.S. (other than cGMPS) and related costs of such changes. Company shall not change the manufacturing site, or the materials, process or plant used in the manufacture of the Products, without first
obtaining the written consent of Cangene to such change, unless it is a type of change or deviation permitted by the Quality Agreement. 

  
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 c) Delivery: Company shall deliver the Products purchased by Cangene Ex Works (Incoterms
2010). Title and risk of loss shall pass to Cangene upon delivery to the carrier selected by Cangene. Cangene shall be responsible for selection of the carrier(s) to arrange pick-up and delivery of the Products, which must be arranged in advance
with Company’s Shipping Department. In the alternative and in exceptional circumstances, Cangene can direct that Company ship the Products to it, at Cangene’s sole expense (including cost of shipping, insurance and all other costs), and
Cangene shall reimburse Company for shipping expenses within [**] days of receipt of an invoice for same. 
 d) Timing of Delivery:
Time is of the essence in relation to the performance of any and all of Company’s obligations pursuant to this Agreement. Products shall be deemed delivered on time if delivered in accordance with all applicable terms and conditions (including
location, Purchase Specifications, requirements and date) and no sooner than [**] days prior to, and no later than [**] days following the delivery date stated in the Purchase Order and confirmed by Company in accordance with Section 2(e)
below. A delivery of non-conforming Products or of non-conforming quantity, or a delivery later than [**] days following the delivery date stated in the Purchase Order, shall be deemed a late delivery (“Late Delivery”). Company agrees to
use its best efforts to meet any request by Cangene for delivery of Products prior to or by the delivery date stated in the applicable Purchase Order. Company shall notify Cangene of any Late Delivery and specify the estimated delivery date and the
circumstances causing the delay, keeping Cangene continually informed about the status of the Late Delivery. For sake of clarity, Delivery date means when the Product is made available to Cangene at Company facility. 

e) Forecasts; Supply; Changes: Cangene will provide a [**] months’ written schedule of estimated requirements of Product which
estimate will be updated [**] by way of [**] rolling forecast which will not be binding (“[**] Rolling Forecast”). Company will advise Cangene in writing, promptly, and in any event within [**] business days of receipt of a forecast, if
any requirements for Product indicated on a forecast conflicts with either an official plant shut down or [**]. Cangene shall submit Purchase Orders for Product in writing to Company for the supply of the Product not later than [**] days prior to
the required date of delivery and Company shall confirm such order in writing within [**] business days (failing which Company shall be deemed to have accepted Cangene’s order for delivery on the date specified in that order). Company shall
accept all Purchase Orders for Product submitted in writing to Company for the quantity of Product identified for the first month of the most recent [**] Rolling Forecast and which are submitted not later than [**] days prior to the required date of
delivery (except to the extent Company advised Cangene within [**] business days of receiving the relevant forecast that the requested delivery date(s) conflict with an official plant shut down or [**]. Due to the [**]), Company will order PFS from
the supplier based on the [**] Rolling Forecast provided by Cangene. [**] PFS will be charged to Cangene at a fixed cost as set forth in Exhibit A attached hereto. All PFS charged to Cangene shall be used by Company only to fulfill its
obligations and complete Purchase Orders under this Agreement. Company shall be responsible for any damage to the PFS while the PFS are in Company’s custody and control. Prices of PFS will be reviewed in future, based on PFS supplier prices.
The cost of PFS, already paid by Cangene, will be deducted from the price of the final Product which will be invoiced to Cangene. 

  
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 f) Changes to Time or Destination: Upon notice to Company from Cangene (which may include
telephone, email or facsimile), Cangene shall have the right to: (i) postpone a Product delivery by up to [**] days, and (ii) indefinitely delay or cancel any Product delivery made unnecessary or impossible due to a force majeure event
affecting either party unless the Products have already been produced or are in production process in accordance with a confirmed Purchase Order. Provided that Product is available in inventory at Company, if requested by Cangene, Company shall
deliver a reasonable quantity of Product on a “rush” basis, to be delivered within [**] hours after any such request. 
 g)
Supply; Purchase Orders: Each Cangene Facility will issue its own Purchase Orders for the Products. Company shall supply Products to Cangene in accordance with Purchase Orders that Cangene may issue to Company from time to time. Purchase
Orders shall specify the quantity of the Product(s) to be purchased by Cangene, the place of delivery, the delivery date, the method of shipment and price. Company shall be responsible for manufacturing the amount of Product requested plus or minus
[**] percent ([**]%). Cangene shall be responsible for payment of all Products manufactured and delivered within this range. 
 h)
Timing & Logistics: The Company Official Correspondent shall notify the Cangene Official Correspondent promptly of the expected delivery of the Products ordered therein, or of any occurrence that would inhibit Company’s ability
to supply the Product(s) to Cangene as requested in the Purchase Order and confirmed by Company. 
  

	3)	Price: 

 a) General: During the Term, Cangene shall pay Company for the Products
provided in accordance with the pricing provisions contained in the Purchase Schedule. Pricing terms are fixed until December 31, 2014. No later than [**] of each year commencing in [**] 2014, prices will be mutually reviewed in good faith by
the parties to take into consideration possible cost increase or decrease and possible volume increase or decrease. In any case, price increase for the following calendar year cannot be more than the increase of the Spanish Price Index publically
available at www.ine.es (official website of the Spanish National Institute of Statistics). 
 Notwithstanding the above, Company will
be entitled to request Cangene increase the price in excess of such Spanish Price Index (IPC), provided Company can demonstrate that the costs in any material used in the manufacturing of Product have increased more than the applicable IPC. At such
request, the parties will negotiate in good faith and should the parties be unable to agree to the applicable increase within a reasonable period of time, any party will be entitled to refer such pricing dispute to binding arbitration pursuant to
the provisions of Section 20(g). In such interim period, current prices will be applicable to orders for Product. 
 b) Fees for the
Dossier: Any and all fees in conjunction with the development of the Dossier shall be borne by Company. Subject to Section 6, Company will provide free and unrestricted access to the Dossier to Cangene upon Cangene’s request. 

  
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 c) Invoice Payment: Company shall prepare and deliver to Cangene an invoice for each
shipment of Product purchased hereunder. Company shall submit invoices to Cangene Accounts Payable at the following billing address, preferably by electronic mail (except as otherwise directed by Cangene): 

CNJ Holdings Inc. 
 d/b/a Emergent
BioSolutions 
 155 Innovation Drive 

Winnipeg, Manitoba R3T 5Y3 

Attention: Accounts Payable 
 [**]

 All invoices shall be submitted contemporaneously with or subsequent to the delivery of the Products. The invoices shall be in writing,
shall specify the price in respect of the Product delivered, the Purchase Order number, the quantity of Product delivered, any shipping costs and the invoice amounts, and shall be stated and paid in Euros In no event shall any invoice be dated prior
to the date of delivery of the related Product. 
 d) Payment Terms: Payment terms for each shipment of Products (except to the extent
disputed in good faith) shall be net [**] days from receipt of invoice; provided that no invoice shall be dated prior to the shipment of corresponding Products. Payment shall be due net of any and all credits due to Cangene, including without
limitation, credit for returns, recalls, and/or warranty replacements. 
 e) Payment Method: Payment by Cangene for orders of Product
shall be in Euros. Payment shall be made by bank transfer in immediately available funds to Company as follows: 
  

			
	 Name on account:
	  	Rovi Contract Manufacturing, S.L.
	 Account Number:
	  	[**]
	 Bank Name:
	  	[**]

  

	4)	Specifications and Quality. 

 a) Specifications: Each Product delivered pursuant
to this Agreement shall comply with the Purchase Specifications. Certificates of Analysis showing size and description, lot or batch number, date of manufacture, site or plant of manufacture, and the specifics of the analysis of all Product
properties requested by Cangene, will be provided by Company with each lot of Product. Whenever reasonably possible, shipments (to all centers) shall consist of a single manufacturing lot in pallet quantities. All Products delivered hereunder shall
be delivered within [**] weeks of the date of manufacture, unless otherwise approved by Cangene. 

  
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 b) Shipping: Care and Handling Restrictions. 

(i) General: Company shall label, pack and deliver all Products in accordance with cGMPs, the applicable Laws to the manufacturing
process performed by Company and the Purchase Specifications. 
 (ii) Purpose and Manner: The storage and distribution of Products by
Company shall be such as to maintain the integrity of the Products, including maintaining appropriate conditions of temperature, humidity, and light. Company shall store all ingredients, materials and Products in a clean, dry area, free from insects
and rodents, in a manner to prevent entry of foreign materials. Company shall not manufacture, store or process any materials or Products in the same building in which Company manufactures, stores or processes [**]. 

(iii) Changes: Subject to applicable Laws, Purchase Specifications, or any other characteristic of the Products, may only be changed
with Cangene’s prior written consent, except for changes and deviations permitted by the Quality Agreement. Company shall not unreasonably withhold its agreement to any change in the Purchase Specifications requested by Cangene. Company shall
not make any substitutions for Products ordered without the prior written approval of Cangene, and in any event, no changes shall be made by Company without first providing Cangene with at least [**] days’ prior written notice. 

c) Testing: Company shall ensure that quality assurance tests agreed by the parties from time to time are adopted. Company shall ensure
that testing methodology and testing reference standards comply with cGMPs. Company shall notify Cangene of any adverse trends that become apparent during the testing of the Product. Company shall provide Cangene with a Certificate of Analysis (COA)
and a Certificate of Conformity (COC) for each Product lot provided to Cangene, and any and all other documentation required pursuant to the Quality Agreement. Cangene shall have the right to test or have tested Products with respect to all
characteristics deemed relevant by Cangene, including without limitation, any aspect of the Purchase Specifications. 
 d) Acceptance:
In the event that a shipment of Products fails to conform to Purchase Specifications, Cangene, at its option and at the expense and risk of Company, shall notify Company and store them pending instructions from Company as to their disposal, which
disposal costs shall be borne by Company. The payment obligation in relation to any such delivery may be suspended pending resolution of any dispute with respect to defective Products. Neither payment nor passage of title or risk of loss to the
Product(s) to Cangene shall be deemed to constitute acceptance of the Product(s). Acceptance of any lot of Products shall not relieve Company of its warranty obligations under this Agreement. 

e) Disputes/Credits/Replacement: 

(i) Cangene, or its third party representative, shall inspect any shipment which evidences outward damage and shall notify the Company as soon
as practicable but, in any event, in not more than [**] Business Days from delivery, so that Cangene and Company can assess whether the carrier is liable for such damage. Acceptance of a shipment does not relieve Company of its warranty obligations
as set forth herein; 

  
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 (ii) If Cangene shall have performed the same tests as Company and the results from its tests are
not consistent with the test results obtained by Company, Cangene shall notify Company as soon as practicable, and the parties agree to use test results obtained by a mutually acceptable qualified third party as a basis for acceptance or rejection
of the lot. The cost of such third party testing shall be borne by Company if the shipment of the Product is found not to conform, or by Cangene if found to conform; 

(iii) Company will give Cangene credit for, refund, or replace, at Cangene’s sole election, any lot of the Products which does not meet
the Purchase Specifications for the Products, except to the extent that the lot of the Products did not meet Purchase Specifications as a result of Cangene’s negligent acts or omissions. Such credit or refund shall be limited to the invoice
amount for the lot of the Products rejected. Company shall have no further obligation relating to the disposition of such rejected shipment, except as provided in subparagraphs (iv) and (v) below; 

(iv) Cangene shall hold any rejected lot of the Product until authorized by Company to return or destroy it, which authorization shall be
granted as soon as practicable. Company will be responsible for all costs relating to return or destruction of any rejected lot of the Product found not to conform to Purchase Specifications; and 

(v) If Cangene elects to request replacement goods, such Product shall be replaced by making replacement Product available for delivery within
[**] weeks of request (except to the extent a delay is caused because Prefillable syringes are not in stock at Company) or within such other timeframe agreed upon by the parties. If such replacement Product is not delivered within such time period,
Cangene shall have the right to terminate this Agreement, effective immediately upon notice to Company. 
 f) Samples: Company shall
retain samples of each batch of Products for a period not less than [**] following the expiration date of such batch of Products or as otherwise set forth in the Quality Agreement. 

g) Facilities, Equipment and Raw Materials. Company shall be responsible for dedicating appropriate Company facilities, and for
obtaining, installing and maintaining in such Company facilities all capital equipment, as needed to manufacture the amounts of Products as ordered by Cangene. Company shall allocate sufficient time, effort, equipment and facilities to the program
for manufacturing Products, and shall dedicate and use personnel with sufficient skills and experience as are required to accomplish the manufacturing tasks, so as to manufacture and deliver Products on a timely basis and in accordance with the
terms of this Agreement. Company shall conduct its manufacturing efforts under this Agreement in compliance with applicable Laws to the manufacturing activity to be performed by Company under this Agreement and cGMPs. Company shall be responsible
for procuring all raw materials needed for manufacturing Products. At Cangene’s request, Company shall provide Cangene with specifications, sources and other information regarding such raw materials. 

  
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 h) Records: Upon Cangene’s request, Cangene shall have the right to review all
Company production and control records in relation to the Product to determine compliance with cGMPs, and all approved written procedures and Purchase Specifications prior to the delivery of the Products. Any unexplained discrepancy shall be
promptly and thoroughly investigated by Company. A written record of the investigation shall be made and shall include the conclusions and follow-up. A copy of the investigation and follow-up shall be provided to Cangene. 

i) Regulatory and Environmental Compliance: 

(i) As provided in the Quality Agreement, Company shall promptly report to Cangene any and all information reported to Company relating to any
adverse experience, whether expected or unexpected, relating to the use of the Product. 
 (ii) Inspections: If Company is notified
that the Products or the manufacturing facility at which the Products are manufactured and identified in Exhibit A will be subject to an inspection in relation to, or that could impact, the Product by any Governmental Authority, Company
shall: (i) within [**] Business Days advise Cangene regarding such inspection; (ii) fully cooperate with and allow any such inspection to the extent required by Laws; (iii) promptly provide inspection summaries to Cangene; and
(iv) promptly send to Cangene a copy of any inspection report observations issued by a Governmental Authority related to the manufacture, generation, processing, storage, treatment, disposal or other management of the Products, as well as
responses to any inspection reports prepared in accordance with this Section. Nothing shall oblige Company to disclose information to Cangene relating to any other customer of Company or such products to which the inspection relates, unless such
information relates specifically to the Products or is of a general nature relating to the manufacturing facility at which Company manufactures Products, in which case the information shall promptly be disclosed to Cangene. 

(iii) Notice of Inspections: If any Governmental Authority shall take any action which shall require a response or action by Company
with respect to Products, Purchase Specifications, or the manufacturing facility at which Products are manufactured, or any operating procedure affecting the Products, Company shall immediately notify Cangene of the required response or action and
allow Cangene to provide Company with input regarding the response or action. 
 (iv) Amendments to cGMPs: The Parties will promptly
notify each other of any material revisions or amendment of or additions to cGMPs and will confer with each other with respect to the best means to comply with such requirements. 

(v) Personnel and Safety: Company is solely responsible for the safety and health of its employees, consultants and visitors and
compliance with all applicable Laws related to health, safety and the environment, including, without limitation, providing its employees, consultants and visitors with all appropriate information and training concerning any potential hazards
involved in the manufacture, packaging, storage and supply of the Products and/or materials and taking any precautionary measures to protect its employees from any such hazards. Company shall ensure that all waste generated in the manufacturing or
processing of the Products is managed and disposed of in accordance with all applicable Laws related to such activity. 

  
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 (vi) Audit: Cangene shall have the right during the Term to audit and inspect those
portions of Company’s manufacturing facility used in the manufacture, generation, storage, testing, treatment, holding, transportation, distribution or other handling or receiving of the Products. Cangene shall have the right to audit and
inspect all inventory of the Products contained at such facility. Except as otherwise set forth in this Agreement, such audits or inspections shall occur not more than [**] per year and shall be scheduled during regular business hours by Cangene at
least [**] days in advance; provided, however, that in the event of an Adverse Event or any proposed or actual inspection by a Governmental Authority or other emergency involving the Products or such facility, Cangene shall have the right at any
time upon [**] Business Days’ oral or written notice to Company to conduct an audit or inspection of such facility, which audit or inspection shall not count against the annual cap of [**]. Purposes for such inspections may include cGMP
compliance, system audits, compiling information for reporting obligations, compliance with Purchase Specifications, and/or investigations of complaints and/or compliance with any applicable Laws or the terms of this Agreement or the Quality
Agreement. Cangene’s audit and inspection rights under this Section shall not extend to any portions of such facility, documents, records or other information: (i) which do not relate to the Products, or (ii) to the extent they relate
or pertain only to third parties or their products or materials. 
 (vii) Other Regulatory Support: Subject to Section 6, Company
will provide data relating to any of the Products as needed by Cangene for Cangene’s regulatory filings of products containing the Products throughout the world, per the charges set forth in Exhibit A. 

(viii) Stability: Additional stability studies and associated costs shall be mutually agreed between the parties. 

j) Recalls: 
 (i)
General. For the avoidance of doubt, references to “recall” within this Agreement shall be deemed to include any product withdrawal, recovery, or other field correction. Cangene shall direct and control responses to all recalls of
any Coagulation Products containing the Products, and Company shall provide reasonable cooperation to Cangene in connection with any such responses as further set forth in the Quality Agreement. In the event: (i) any Governmental Authority or
other national government authority issues a request, directive or order that any Product be recalled; (ii) a court of competent jurisdiction orders a recall of any Product; or (iii) Cangene reasonably determines that any Product should be
recalled, the parties shall take all appropriate corrective actions, and shall cooperate in any governmental investigations surrounding the recall. 

  
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 (ii) Expenses. In the event that any recall results from, or relates to a Product, Company
shall be responsible for promptly replacing the quantity of Products that were recalled, at no cost to Cangene, or reimbursing Cangene for the cost of the recalled Products. In addition, Company shall be responsible for the administrative expenses
of any recall which shall include, but not be limited to, the expenses of notification and destruction or return of the recalled product, and any costs associated with the distribution of the replacement product, but shall not include lost profits
of either Party. Notwithstanding the foregoing, in the event that the recall results from Cangene’s breach of this Agreement or Cangene’s negligence or willful misconduct, Cangene shall be responsible for all of the expenses of the recall.

 (iii) Communications. With respect to any recall, Cangene shall make all statements to the media and the public including, but not
limited to, press releases and interviews. Company will not issue any press release or otherwise make any public statement, advertisement or disclosure with respect to this Agreement, any of the Products, or any recall relating to any product
manufactured by Cangene containing Products without the prior written consent of Cangene; provided, however, that either party shall be entitled to make a public announcement relating to such events if, in the opinion of the announcing party’s
legal counsel, such announcement is required to comply with Laws and provided to the extent practicable that the other party has received not less than [**] Business Days notice. 

k) Labeling: The specific obligations of the Parties with respect to labeling and related requirements for the Product shall be agreed
to by the Parties in the Purchase Specifications as set forth in Exhibit B and in applicable Purchase Orders. 
  

	5)	Supply Guarantee: Company guarantees that it shall use its best efforts to supply the quantity of Products ordered by Cangene and confirmed by Company during the Term of this Agreement. In the event Company is
unable to supply the quantity of Products requested by Cangene, Company shall provide immediate written notice to Cangene. In the event this Agreement terminates for any reason other than Cangene’s failure to pay undisputed amounts, Cangene
shall be entitled to purchase Product from Company, pursuant to the terms and conditions of this Agreement, for a period of [**] months following the date of any notice of termination. For sake of clarity, quantities of Product ordered during such
[**] month period following the date of any notice of termination, should be in line with quantities previously ordered by Cangene. 

  

	6)	Rights to the Dossier: 

 a) Grant of Rights. Subject to the limitation set forth
in the following paragraph, Company hereby grants to Cangene, and Cangene hereby accepts, the right to utilize the Dossier and its contents for obtaining and/or maintaining marketing authorizations anywhere in the world for the Coagulation Products.
For the purpose of obtaining and/or maintaining regulatory approval of its Coagulation Products (which include the Product), Company will provide Cangene a letter of access to its Dossier for relevant Governmental Authorities. 

  
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 As a limitation in the use of the Dossier, as of the Effective Date, Cangene accepts and commits
not to incorporate the stability data included in the Dossier as of the Effective Date, into any Drug Master File (DMF) for their own products or for any third party products. For clarity, nothing herein shall restrict Cangene from incorporating by
reference the stability data included in the Dossier (including without limitation the data in the DMF for the Products) in its regulatory submissions (other than a DMF) for the purposes of obtaining or maintaining regulatory approvals for
Cangene’s Coagulation products (which includes the Product). 
 b) Changes to Dossier. Company agrees to promptly inform Cangene
in writing on a regular and continual basis of any changes or updates to the Dossier that could potentially impact Cangene’s marketing authorizations for the Coagulation Products anywhere in the world. 

 

	7)	Ownership of the Dossier. Company will at all times remain owner of the Dossier. Cangene shall own all the marketing authorizations for the Coagulation Products obtained by Cangene anywhere in the world.

  

	8)	Use of the Dossier. Except as otherwise set forth in this Section 8 or otherwise prohibited hereunder, each party shall have the right to sublicense its rights described in Section 6(a) above to third
parties, provided that the names of each sublicensee shall have been disclosed to the other party and that the sublicensing party warrants that each sublicensee will satisfy any obligations applicable to such sublicensee. 

 

	9)	Representations and Warranties: 

 a) Conflicts: Each party represents and warrants
to the other party that the execution and delivery of this Agreement and the performance of its obligations hereunder (i) do not conflict with or violate any requirement of applicable Laws or regulations, and (ii) do not conflict with, or
constitute a default under, any contractual obligation of such party. 
 b) Authority: Company warrants title to Products sold
hereunder to be free and clear of all liens, encumbrances and/or colorable claims at the time of delivery. 
 c) Quality: Company
warrants that all Products shall be free from any latent or patent defects, and shall conform to applicable Purchase Specifications. Company further represents and warrants that all Products shall have been manufactured, stored, prepared for
shipment and shipped in accordance with cGMPs, standard operating procedures, Purchase Specifications, and Purchase Orders. For any ancillary services rendered in connection with this Agreement, Company represents and warrants that all such services
shall be performed in conformity with the highest standards practiced by companies that perform services of a similar nature, at the time and place the services herein are performed, and that Company shall use its best efforts in the performance of
all services. 
 d) Compliance: Company further warrants that in the performance of this Agreement, Company has complied and will
comply with cGMPs and all applicable Laws. 

  
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 e) Ownership of the Dossier. Company represents and warrants that it owns and has good and
marketable title to the Dossier and its contents (including stability data with respect to the Product), and, save that the stability data included in the Dossier can not be assigned to any party for the purposes of incorporating such stability data
into any DMF, the ownership of the Dossier is free and clear of any liens or encumbrances of any kind. 
 f) Ownership of Intellectual
Property. Company owns, or has a valid license to use, any and all proprietary processes, methods, or models used by Company to manufacture the Product. 

g) No Infringement. Company represents and warrants that, to its knowledge, neither (i) the Dossier, (ii) the design, the
manufacture, nor the function of the Products (including packaging), nor (iii) the provision, use, or sale of Products shall in anyway infringe upon or violate any intellectual property rights or other rights of any third party. 

h) Regulatory Compliance. Company represents and warrants that any Product which constitutes material which is, will become, or is
intended to become a part of the Coagulation Products, shall, at the time of delivery, not be adulterated or misbranded within the meaning of any applicable Law. 

i) No Litigation. Each party represents and warrants to the other party that no lawsuit, governmental investigation or legal,
administrative or arbitration action or proceeding is pending or, to the knowledge of such party, threatened against such party, or any director, officer or employee of such party in his or her capacity as such, which questions the validity of this
Agreement or seeks to prohibit, enjoin or otherwise challenge the consummation of the transactions contemplated hereby. 
  

	10)	Indemnity: 

 a) By Company: Except to the extent caused by Cangene’s
intentional misconduct, gross negligence, or material breach of this Agreement, Company shall indemnify, defend and hold harmless Cangene and its Affiliates and the directors, officers, employees, partners, members, agents and counsel of the
foregoing, and the successors and assigns of any of the foregoing (the “Indemnitees”), from and against any and all liabilities, damages, losses, costs or expenses (including reasonable attorneys’ and professional fees and
other expenses) (collectively, “Costs”) arising out of, in connection with or as a result of (i) Company’s breach of this Agreement, including without limitation the failure to deliver Product in the quantity, at the times
and in the manner specified herein, the supply of Nonconforming Product, or breach of any of Company’s representations or warranties or other obligations under this Agreement, including without limitation, in respect of recalls pursuant to
Section 4(j), (ii) Company’s negligence or willful misconduct or (iii) any claim of infringement relating to the Products (each, a “Claim”). 

b) By Cangene: Except to the extent caused by Company’s intentional misconduct, gross negligence, or material breach of this
Agreement, Cangene shall indemnify, defend and hold harmless Company and its Affiliates and the directors, officers, employees, 

  
 13 

 
partners, members, agents and counsel of the foregoing, and the successors and assigns of any of the foregoing (the “Indemnitees”), from and against any and all Costs arising out
of, in connection with or as a result of (i) Cangene’s breach of this Agreement, including any of Cangene’s representations or warranties or other obligations under this Agreement, (ii) Cangene’s negligence or willful
misconduct or (iii) any claim of infringement relating to the Coagulation Products (but excluding the Products specifically) (each, also a “Claim”). 

c) Procedure: The Indemnitee seeking to be indemnified shall notify in writing the other party (the “Indemnitor”)
stating the nature of the Claim. In the event of a Claim instituted by a third party, the Indemnitee shall (i) give the Indemnitor, at the Indemnitor’s option, the full opportunity to control the response thereto and the defense thereof,
including any agreement relating to the settlement thereof, provided that the Indemnitor shall not settle any such Claim or action without the prior written consent of the Indemnitee (which consent shall not be unreasonably withheld or delayed) or
such settlement include as an unconditional term thereof the giving by the claimant of an unconditional release from all liability in favor of the Indemnitee; and (ii) cooperate with the Indemnitor, at the Indemnitor’s cost and expense, in
the defense or settlement thereof. Notwithstanding the foregoing, the indemnification obligations hereunder shall not be relieved hereunder for failure to do the foregoing, or delay with so doing, unless the Indemnitor is materially prejudiced
thereby. In addition, the Indemnitee may, at its own expense, participate in its defense of any Claim. An Indemnitee shall use its commercially reasonable efforts to mitigate any Claim. 

 

	11)	Damages and Liability: 

 a) Damages: NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS, SAVINGS OR REVENUES OF ANY KIND OR FOR ANY TYPE OF DIRECT OR INDIRECT DAMAGES RELATED TO THE IMAGE OR REPUTATION OF ANY OF THE PARTIES, EXCEPT TO THE EXTENT
THAT SUCH DAMAGES ARE CAUSED BY THE WILLFUL MISCONDUCT BY A PARTY, ITS EMPLOYEES, AGENTS, REPRESENTATIVES, OR SUBCONTRACTORS. 
 b)
Limitation of Liability: With no prejudice to the foregoing, in no event shall either party incur monetary liability to the other, annually in the aggregate, for breach or violation of this Agreement, or for any other acts or omissions in
connection with the performance under this Agreement in excess of three (3) times the amounts invoiced by Company under this Agreement for Product during the 12 months period preceding the incident, with a maximum limit of six (6) million
Euros. As an exception to the foregoing and only in case of third party Claims or Costs resulting or arising from defective or infringing product (Company’s or Cangene’s, as the case may be), such limitation of liability to the other
Party, annually in the aggregate, shall amount to six (6) million Euros (and for clarity, shall not be limited to the above mentioned multiple of the amounts invoiced). The parties agree that the monetary remedies to which any Party may be
entitled hereunder are in addition to any equitable remedies such Party may have. 

  
 14 

 c) Specific Performance: Company acknowledges and agrees that if Company does not timely
perform its obligations hereunder to deliver Product, replace Nonconforming Product or provide all required documentation in accordance with the terms of this Agreement, irreparable damage would occur to Cangene. Accordingly, Company agrees that
Cangene shall be entitled to seek injunction or injunctions to prevent Company’s breach of this Agreement and to enforce specifically such terms and provisions of this Agreement. Company does not waive any other remedies or defenses it may
possess at law or equity with regard to any such action(s). 
  

	12)	Insurance: 

 a) General: Each party, at its own expense, shall obtain insurance
with carriers approved by the other party in at least the amounts shown below. All required policies shall be issued by an insurer that is licensed to do business in the state where the project is located. All policies shall be issued by an insurer
that has an A.M. Best rating of not less than “A” and Standard & Poor’s rating of not less than “AA”. Each party shall submit to the other party, prior to commencement of Product deliveries under this Agreement,
certificates of insurance evidencing that such insurance was obtained. The parties undertake that [**] days advance notice will be given by registered mail to the other party of cancellation, expiration, reduction, or modification in amounts of
coverage. Each party shall maintain insurance in force or other insurance with another carrier in at least the same conditions as set out in this clause by the parties during the Term of this Agreement and for [**] years thereafter. Each party shall
be financially responsible for all deductibles or self-insured retentions. It is expressly understood that neither party, in any way, represents that the minimum limits of insurance specified herein are sufficient or adequate to protect interests or
liability of the party. 
 b) Specific Coverage: 
  

			
	Commercial General Liability	  	 Company shall maintain Commercial General Liability insurance on an occurrence basis with a minimum € [**] per occurrence limit for
bodily injury, property damage, personal and advertising injury, € [**] aggregate limit for products/completed operations and a € [**]general aggregate limit. This Commercial General Liability insurance to include coverage for the hazards
of the tort liability of another assumed in a business contract, Independent Contractors
  

Cangene shall maintain Commercial General Liability Insurance, with policy limits of not less than [**] Dollars (CDN $[**]) for each occurrence and in the
aggregate per annum for bodily injury, property damage, product and completed operations liability.

		
	Worker’s Compensation	  	Each party, its subcontractors, if any, and all employees providing work, labor, or materials under this contract are subject employers under the Workers’ Compensation Law of the jurisdiction where the party is located, which
requires them to provide workers’ compensation coverage that satisfies the law of the jurisdiction for all their subject workers. For Company, this shall include employer’s liability insurance with coverage limits not less than €
[**].

  
 15 

			
		
	Excess Liability	  	 Each party shall maintain its own umbrella or excess insurance, which provides excess limit of liability over and above each parties
respective Commercial General Liability Insurance referred to above, subject to the following minimum limits:
  

•    For Company, a minimum of € [**] limit per occurrence and € [**] annual
aggregate limit;
  

•    For Cangene, a minimum of CDN $[**] limit per occurrence and $[**] annual aggregate
limit.
  
 The required umbrella/excess insurance is not required to sit above the
required Product Liability Insurance each party is required to maintain.

		
	Company’s Equipment	  	Company shall be responsible for any loss, damage or destruction of its own property, equipment, and materials used in conjunction with this work. Company will purchase at Company’s sole cost and expense such policy to cover
Company’s owned property. Company will be responsible for any deductibles or self-insured retentions associated with such policy. If Company self-insures owned property then Company acknowledges full responsibility for all owned property and
indemnifies owner against any loss incurred. The Company shall require all subcontractor’s to provide evidence of Company’s equipment floater covering their own equipment, and materials used in conjunction with this work.
		
	Product Liability	  	 Company shall maintain Product Liability Insurance in a minimum amount of [**] euros (€[**]) per occurrence for bodily injury and
property damage and [**] euros (€[**]) in the aggregate which will cover each party’s activities under this Agreement.
  

As stated above, Cangene shall maintain Commercial General Liability Insurance, with policy limits of not less than [**] Dollars (CDN $[**]) for each
occurrence and in the aggregate per annum, including products and completed operations liability.

		
	Pollutants and Hazardous Materials	  	If Company is to work with pollutants (i.e. chemicals, biohazard, etc.) in connection with its obligations hereunder, Company will carry insurance for liability resulting from bodily injury, property damage or clean-up costs arising
out of the actual, alleged or threatened discharge, dispersal, seepage, migration, release or escape of pollutants.

  

	13)	Subcontracting: Company shall not enter into a subcontract with respect to the subject matter of this Agreement, without the prior written consent of Cangene. No such written consent shall relieve Company from
any of its obligations or liabilities hereunder. Nothing herein shall constitute any contractual relationship between Cangene and any subcontractor of Company or any obligation on the part of Cangene to pay, or be responsible for the payment of, any
sums to any such subcontractors. Company shall be responsible for all work performed by, and for acts, omissions, or negligence of its subcontractors and for compliance of its subcontractors with the requirements of this Agreement, and all
applicable Laws to the same extent that Company would be responsible if Company were doing such work directly. 

  
 16 

	14)	Confidential Matters: 

 a) General: During the course of the performance of this
Agreement, either party (as “Discloser”) may disclose certain information relating to this Agreement to the other party (as “Receiver”). Receiver shall keep in strictest confidence all information relating to this
Agreement which may be acquired in connection with or as a result of this Agreement which has been designated as proprietary to Discloser or which from the surrounding circumstances ought to be treated as proprietary to Discloser
(“Confidential Information”). During the Term of this Agreement and for [**] years thereafter, without the prior written consent of Discloser, Receiver shall not publish, communicate, divulge, disclose, or use any Confidential
Information, except as otherwise provided herein. Upon termination or expiration of this Agreement, Receiver shall deliver all of Discloser’s Confidential Information and all copies thereof to Discloser, to Discloser, and such shall remain the
property of Discloser. Purchase Specifications and changes to the Purchase Specifications, the Dossier, and pricing for the Products shall be treated as Confidential Information by both parties. 

b) Exceptions: Nothing in this Section shall be construed to impose an obligation of confidentiality on Receiver in connection with any
information to the extent such information: 
  

	 	(i)	is at the time of disclosure already known to Receiver, as clearly established by competent evidence; 

  

	 	(ii)	is at the time of disclosure or subsequently becomes part of the public domain through no fault, act or omission by Receiver; 

  

	 	(iii)	is subsequently disclosed to Receiver by a third party whose receipt and disclosure of such information does not constitute a violation of any confidentiality obligation; or 

 

	 	(iv)	is independently developed by the Receiver without use of the Confidential Information. 

 c)
Survival: The obligations of confidentiality imposed on Receiver herein shall survive any termination or expiration of this Agreement. 

d) Governmental Requirements: In the event Receiver is asked or subpoenaed by a court of law or governmental agency to provide
Confidential Information received hereunder, Receiver shall promptly inform Discloser and shall cooperate with Discloser to obtain any and all protection that may be afforded such Confidential Information, prior to disclosing it, if such disclosure
is ultimately required. Further, notwithstanding the above or any other provision herein, Cangene or its authorized agents may provide Confidential Information and documentation to any regulatory authorities to allow Cangene or its authorized agents
to pursue regulatory licensure of its products/processes and to become and/or remain in compliance with regulatory requirements and guidelines. 

  
 17 

 e) Copies: Receiver shall, upon request by Discloser, return or destroy all Confidential
Information received hereunder, except, and only upon written request by Receiver, for (i) one (1) photocopy that may be kept in its legal archives solely for the purpose of monitoring Receiver’s obligations hereunder, provided such
photocopy is reasonably secured to maintain the confidentiality thereof; and (ii) electronic copies of documents created by a party’s automatic archiving procedures that are not readily accessible for destruction. 

f) Publicity and Disclosures: Each party shall maintain the confidentiality of this Agreement and all provisions of this Agreement and,
without the prior consent of the other party, no party shall make any press release or other public announcement of or otherwise disclose this Agreement or any of its provisions to any third party (a) other than to its directors, officers and
employees and attorneys, accountants, investment bankers and other professional advisers whose duties reasonably require to maintain the confidentiality of this Agreement and (b) except for such disclosures as may be required by applicable law
or by regulation, in which case the disclosing party shall provide the other party with prompt advance notice of such disclosure so that the other party has the opportunity if it so desires to seek a protective order or other appropriate remedy.

  

	15)	Records: During the Term of this Agreement and for [**] years thereafter or such longer period as may be required by the Quality Agreement or applicable Laws, Company shall maintain complete and accurate records
relating to the supply of Products by Company and Company’s compliance with the terms and conditions of this Agreement, including without limitation the Purchase Specifications. All such records shall be made available for inspection and audit
by Cangene or its authorized representatives during the Term of this Agreement and for [**] years thereafter. 

  

	16)	Force Majeure: 

 a) General: No liability shall result from delay in performance,
or non-performance, caused by events including, without limitation, acts of God, fire, flood, war or acts of terrorism or threatened acts thereof, to the extent such events are beyond the reasonable control of the party affected; provided that the
party invoking force majeure promptly furnishes the other party with written notice detailing the nature of the force majeure event, and the anticipated duration of its impact on the ability of the affected party to perform its obligations under
this Agreement. In order to receive the protection of liability afforded in this Section, the party affected by the force majeure event shall use its best efforts to minimize the impact of the cause or potential cause of its delayed performance or
inability to perform. At Cangene’s option, quantities of Product so affected may be eliminated from any obligation under a particular Purchase Order or this Agreement without liability, but this Agreement shall remain otherwise unaffected. In
the event the force majeure event from which Company claims relief lasts or is reasonably expected to last longer than [**] days, Cangene may, without liability or penalty, terminate this Agreement or any particular Product order issued hereunder.

  
 18 

 b) Allocation: If due to force majeure or any other shortage not reasonably foreseeable,
the quantity of Products available at Company’s (or Company’s supplier’s) facility ordinarily producing Products and deliverable to the Destination Point for sale hereunder should be insufficient to fulfill Company’s Product
volume commitments, Company has the right and obligation to allocate its available supply of Products equitably among all term contract customers of Company during the period of such shortage. In order to achieve an equitable allocation result,
Company shall consider its customers’ supply alternatives. If the allocation is expected to cause greater hardship to Cangene due to its dependence on Company as a majority supplier, then Company’s allocation arrangements will reflect
Cangene’s greater need for Company’s Products. 
  

	17)	Term and Termination: 

 a) Term: This Agreement shall commence as of the Effective
Date and, unless earlier terminated as provided herein, shall expire on the date that is five (5) years from the Effective Date (the “Term”). Thereafter, the Agreement shall automatically renew for five-year terms unless
Company provides Cangene with written notice of its intent not to renew the Agreement no later than twenty-four (24) months prior to the expiration of the Term or any renewal term. 

b) By Cangene Without Cause: Cangene shall have right to terminate this Agreement for any reason, with or without cause upon at least
twelve (12) months prior written notice. 
 c) By Either Party for Breach: Either party may terminate this Agreement in the event
of breach of a material obligation of the other party if such breach remains uncured thirty (30) days after written notice of such breach is delivered to the breaching party. 

d) Effect of Termination: 

(i) Credits: Upon termination of this Agreement, Company shall promptly pay to Cangene any credits due to Cangene and Cangene shall pay
to Company all undisputed amounts then due and payable. 
 (ii) Purchases: In the event of termination, Cangene shall only be
responsible for the purchase of Product that constitutes a firm order as of the effective date of termination; and Cangene shall not otherwise be responsible for any material ordered by Company in anticipation of forecasts or future orders or for
costs or profits on Products not supplied. Upon Cangene’s request, Company shall promptly ship (at Cangene’s expense) any PFS for which Cangene made pre-payment pursuant to Section 2(e) and that has not been used to fulfill its
obligations and complete Purchase Orders under this Agreement. 
 e) Survival: The respective rights and obligations of the Parties
hereunder shall survive the termination or expiration of this Agreement to the extent necessary for the intended preservation of such rights and obligations including, but not limited to, insurance, indemnification, confidentiality, regulatory
compliance, records retention, audit rights, recall responsibilities, and the right to order Product for a [**] month period pursuant to Section 5. 

  
 19 

	18)	Notice: Any notice required or permitted under this Agreement shall be given to the receiving party in writing by delivery in hand, facsimile transmission (receipt verified), postage prepaid, United States
certified mail, return receipt requested, or recognized national overnight courier service to each respective party’s Official Correspondent with a copy to: 

Cangene:  
 Vicki
Wolff-Long 
 Vice-President & GM 

Emergent BioSolutions 

1111 South Paca 

Street Baltimore, MD 21230 

with a copy to: 
 Francis
St. Hilaire 
 V.P., Legal Affairs and Associate General Counsel 

Emergent BioSolutions 
 155
Innovation Drive 
 Winnipeg, Manitoba, 

Canada R3T 5Y3 
 Facsimile: [**]

 Company:  
 Juan
LOPEZ- BELMONTE ENCINA 
 CEO 

Rovi Contract Manufacturing, S.L. 

Julian Camarillo, 35 
 28037
Madrid, SPAIN 
 Facsimile: [**] 
 In addition,
in the event that correspondence with other personnel of Cangene becomes necessary, copies of such correspondence shall be sent to the Official Correspondent of each party so that the Official Correspondent of each party may keep a complete file.

  

	19)	Use of Trade Name and Trademarks: Each party recognizes that the name of the other party represents a valuable asset of such other party and that substantial recognition and goodwill are associated with such
trade name and such party’s various trademarks. Each party hereby agrees it shall not use the name, insignia, symbol, logo or other identifying information of the other party hereto orally, writing or in electronic format in any advertising,
press release, promotional materials or otherwise without the prior written consent of such other party, except as required by Law or stock exchange listing standards. Nothing in this Agreement constitutes a license entitling a party to use the
other party’s name, logos or trademarks; provided, however, that Cangene may use Company’s name in the packaging and/or labeling of the Products as required by applicable Laws or requested by Company. 

  
 20 

	20)	Miscellaneous: 

 a) Assignment: This Agreement may not be assigned by either party
to any other party without the prior written consent of the other party hereto; provided, however, that Cangene may assign its rights and obligations hereunder, by written notice to Company, to a successor or transferee (whether by merger,
consolidation, purchase, stock purchase, or otherwise) of either all, or substantially all, of the affected assets of Cangene. Any purported assignment in violation of this provision shall be void from the beginning. 

b) Independent Contractor: In all matters relating to this Agreement, the parties shall be acting as independent contractors. Neither
party shall have any authority to and shall not assume or create any obligation, express or implied, on behalf of the other party and shall have no authority to and shall not represent itself as an agent, employee, or in any other capacity of such
other party. 
 c) No Third Party Beneficiaries: No provision of this Agreement shall in any way inure to the benefit of any third
person so as to constitute to any such person a third-party beneficiary of this Agreement or otherwise give rise to any cause of action in any person not a party hereto. 

d) Severability: If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the
validity, legality or enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby. 

e) Waiver: Waiver of any provision of this Agreement, in whole or in part, in any one instance shall not constitute a waiver of any
other provision in the same instance, nor any waiver of the same provision in another instance, but each provision shall continue in full force and effect with respect to any other then-existing or subsequent breach. All waivers by either party must
be contained in a written document signed by the party to be charged and, in the case of Cangene, by an executive officer of Cangene or other person duly authorized by Cangene. 

f) Governing Law: This Agreement shall be governed by the laws of England, without regard to conflicts of laws principles. 

g) Dispute Resolution: All disputes, claims or controversies arising out of or relating to this Agreement or subsequent agreements
between the parties will be resolved solely and exclusively by binding arbitration to be conducted under the Rules of Arbitration of the International Chamber of Commerce (ICC). The arbitration will be held in the jurisdiction of the head office of
the defending party before a panel of three (3) arbitrators (one of which will be selected by Cangene, the next of which will be selected by Company, and the last of which will be selected by the first two arbitrators) and will be conducted in
accordance with the rules and regulations promulgated by the ICC. All expenses and fees of the arbitrator and expenses for hearing facilities and other expenses of the arbitration shall be borne equally by the parties involved in the dispute unless
the involved parties agree otherwise or unless the arbitrator in the award assesses 

  
 21 

 
such expenses against one of the parties or allocates such expenses other than equally between/among the involved parties. Each of the parties shall bear its own counsel fees and the expenses of
its witnesses except (i) to the extent otherwise provided in this Agreement or by applicable law or (ii) to the extent the arbitrator in its discretion determine for any reason to allocate such fees and expenses between/among the parties
in a different manner. 
 h) Remedies: Unless otherwise set forth herein, the rights and remedies set forth in this Agreement are
cumulative with and not exclusive of any other remedy. The exercise by either party of any right or remedy conferred by this Agreement does not preclude the exercise of any other rights or remedies that may now or subsequently exist in law or in
equity or by statute or otherwise. 
 i) Injunctive Relief: The parties recognize and agree that remedies at law for breach by the
other party of the provisions of this Agreement regarding confidentiality may be inadequate and each party shall, in addition to any other rights which it may have, be entitled to injunctive relief. 

j) Amendments: No modification of this Agreement shall be effective unless made in writing and signed by a duly authorized
representative of each party. 
 k) Entire Agreement: This Agreement, with all exhibits hereto (including without limitation, any
Purchase Order) constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior agreements and understandings between the parties (whether written or oral) relating to the subject matter
hereof; provided, however, that (i) in the event the parties have entered or subsequently enter a separate confidentiality agreement related to the subject matter hereof, the provisions with respect to confidentiality obligations shall be
cumulative and (ii) any outstanding purchase orders between the parties shall remain in full force and effect in accordance with their terms. In the event of a conflict between the terms and conditions of this Agreement and any exhibit,
(including without limitation, any Purchase Order) the terms of this Agreement shall control. 
 l) Headings: The headings and
subheadings contained herein are inserted for convenience of reference only and shall in no way be construed to be interpretations of text. 

m) Counterparts: This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which
together shall constitute one instrument. 

  
 22 

 IN WITNESS WHEREOF, the Parties have executed this Agreement as set forth below. 

 

									
	CNJ Holdings Inc. doing business as Emergent BioSolutions	 		 	Rovi Contract Manufacturing, S.L.
					
	By:	 	 /s/ Vicki Wolff-Long
	 		 	By:	 	 /s/ Juan LOPEZ-BELMONTE ENCINA

	Name:	 	Vicki Wolff-Long	 		 	Name:	 	Juan LOPEZ-BELMONTE ENCINA
	Title:	 	V.P and General Manager	 		 	Title:	 	CEO

  
 23 

 EXHIBIT 

A PURCHASE SCHEDULE 
 Pricing
Effective as of [DATE] 
 Products: 
  

	 	•	 	10ml [**] Prefillable syringe [**] with [**] stopper filled with [**]ml WFI [**]. Primary packaging (Syringes) is included in the price below. 

 

	 	•	 	Syringes unlabeled lay down in [**] tubs 

  

					
	 NUMBER OF BATCH /YEAR
	  	BATCH
SIZE	 	PRICE per
UNIT in €
(syringe
included)*
	 [**] batches for initial period
	  	[**]	 	[**]
	 [**]
	  	[**]	 	[**]
	 [**]
	  	[**]	 	[**]
	 [**] or more
	  	[**]	 	[**]

 Packaging Services. Price/syringe on top of above prices: 

 

			
	 ITEM
	  	PRICE per UNIT IN €*
	 Labelling of syringes**
	  	[**]
	 Labelling of syringes and Blistering with PR aside**
	  	[**]

  

	**	Packaging and labelling Material not included (not already defined by Cangene) 

 Other Services: Material
ordered by Company prior to production and pre-paid by Cangene 
  

			
	 ITEM
	  	PRICE per UNIT IN €*
	 Empty Pre-Fillable Syringes (PFS) – 10ml [**]

Prefillable syringe [**] with [**] stopper
	  	[**]
Euros

  

	*	All prices are without taxes 

  
 24 

 EXHIBIT B 

PURCHASE SPECIFICATIONS 
 Packaging
specs 
 Product specs 
  

	 	•	 	Packaging Specifications: Not currently available. Will be defined in a later stage. 

  

	 	•	 	Product Specifications: See next page. 

  
 25 

 ROVI CONTRACT MANUFACTURING, S.L. 

DEPARTMENTO DE CALIDAD 
  

							
	 ESPECIFICACIÓN

PRODUCTO TERMINADO
	  	 Especificación n°:296

	 Concepto: AGUA PARA INYECTABLES 5 ML ROCM

                 
 WATER FOR INJECTIONS 5 ML ROCM
	  	Entrada en vigor: 21.06.12
	  	N° Revisión: 03	  	N°Pág.: 1 de 1
	 Ensayo
	  	 Especificación
	  	Limites	  	Método
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  		  		  	
	[**]	  		  		  	
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]

  
 26 

 [**] 
  

 

  
 27 

	 	•	 	EXHIBIT C 

 QUALITY AGREEMENT 

See next pages. 

  
 28 

 

 
 QUALITY AGREEMENT 

Supplier Quality Agreement Between 

Cangene bioPharma, Inc. 
 (doing
business as Emergent BioSolutions) 
 1111 South Paca Street 

Baltimore, MD 21230 USA 
 And 

Rovi Contract Manufacturing S.L. 

Julian Camarillo, 35 
 28037 Madrid
Spain 

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 1 of 22 

	1.	Introduction/ Purpose 

  

	 	1.1	Scope 

 This Quality Agreement (the “Agreement”) defines the expectations and
responsibilities of both parties for quality activities outlined in this Agreement, related to the supply of materials “Product(s)” purchased from Rovi Contract Manufacturing, S.L. (Rovi) by Cangene bioPharma doing business as Emergent
BioSolutions (Emergent) and referred to in Exhibit B. 
 This Agreement shall begin on the date of the final signature of the parties
and shall remain in full force and effect as long as Emergent is purchasing Products from Rovi or if later, until the later of: (a) the termination of any sales agreement between the parties; or (b) the last expiry date of any Products
purchased by Emergent. Any termination or expiration of this Agreement shall not affect the rights and obligations of either party that by their nature should survive the expiration or termination of this Agreement, including but not limited to
those relating to complaints, documentation and those required to continue under applicable CGMPs. This Agreement supersedes and replaces any other prior Quality Agreement between Emergent and Rovi or the Product(s). 

These Terms and Conditions will be reviewed and updated as required. Revision history will be outlined in Exhibit E. Unless otherwise defined
herein, capitalized terms used herein shall have the meaning defined in Exhibit D Glossary of Terms. 
 In the event of a quality conflict
between the Supply Agreement and these Terms and Conditions, the Supply Agreement shall prevail, unless these Terms and Conditions expressly contemplates the conflict and refers to SupplyAgreement, in which case the provisions of these Terms and
Conditions shall prevail. 
 This Supplier Quality Agreement applies to all material identified in Exhibit B. 

 

	 	1.2	Parties to the Agreement 

  

			
	 Between
	  	 And

	Cangene bioPharma (doing business as Emergent BioSolutions) 1111 South Paca Street Baltimore, MD 21230 USA	  	Rovi Contract Manufacturing, S.L. CL Julian Camarillo, 35 28037 – Madrid Spain
		
	(Referred to as “Emergent”)	  	(Referred to as “Rovi”)

  
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 The parties hereto have each caused this Agreement to be executed by their duly-authorized
representatives on the date and year hereinafter set forth. 
  

							
	 Emergent Approval
	  	 Rovi Approval

	Signature:	  	 /s/ Minerva Devera
	  	Signature:	  	 /s/ Ana Sanchez Otero

	Name (print):	  	Minerva Devera, DBA, QSM	  	Name (print):	  	Ana Sanchez Otero
	Title (print):	  	Director, Quality Assurance, Regulatory Affairs, and Validation	  	Title (print):	  	Quality Director
	Date:	  	May 23, 2014	  	Date:	  	June 29, 2014

 Neither party shall have the right to assign any or all of its rights or obligations under this agreement
without the other party’s prior written consent, which shall not unreasonably be withheld. 
  

	2.	Responsibilities for Quality Activities 

 This Agreement will outline the
responsibilities of Rovi and Emergent with regard to the quality activities described in the quality criteria listed below and in Exhibit C. 
  

	3.	Definition of the Quality Criteria 

 Rovi shall conduct all activities concerning the
Product(s) in accordance with the quality criteria defined in the current versions of: 
  

	 	•	 	21CFR11, 210, 211EU Volume 4 

  

	 	•	 	USP and EP Pharmacopeia 

  

	 	•	 	ISO 9001 Quality Management Systems 

 Emergent shall audit Rovi activities concerning the
Product(s) to ensure they meet Emergent’s requirements for incoming material suppliers in accordance with: 
  

	 	•	 	21CFR11, 210, 211 

  

	 	•	 	EU Volume 4 

  

	 	•	 	USP and EP Pharmacopeia 

  

	 	•	 	ISO 9001 Quality Management Systems 

  

	4.	Supply Chain: Manufacturing to Distribution Channels—Site(s) Involved 

 The terms
and conditions of this agreement shall apply to all of Rovi’s facilities involved in manufacturing, storing, handling, distributing, packaging/re-packaging, labeling/re-labeling, inspection/re-inspection, testing and release activities of the
Product(s) provided to Emergent. This includes primary use and alternate use sites. 

  
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 If Rovi uses third parties to perform these activities such use is noted in Exhibit B. 

Changes in the use of third parties or change in the sites involved in the supply chain (i.e affiliate sites) as set forth in this Agreement
shall not be made without prior written notification to Emergent. Rovi shall, however, retain all obligations under this Agreement whether or not a third party manufactures, stores, handles, distributes, packages/re-packages, labels/re-labels,
inspects/re-inspects, tests, or releases Product(s). 
  

	5.	Quality Management System 

 Rovi shall have an effective, structured quality system in
place that implements the following quality activities: 
  

	 	•	 	Compliance 

  

	 	•	 	Processing, Packaging and Labeling 

  

	 	•	 	Documentation and Records 

  

	 	•	 	Storage and Distribution 

  

	 	•	 	Change Control 

  

	 	•	 	Non-Conformance 

  

	 	•	 	Out of Specification 

  

	 	•	 	Deviations 

  

	 	•	 	Complaints 

  

	 	•	 	Recalls 

  

	 	•	 	Auditing 

  

	 	•	 	Training 

  

	 	•	 	Lot Disposition 

  

	 	•	 	Stability Program 

  

	 	•	 	Raw Materials 

  

	 	•	 	Validation and Maintenance 

  

	 	•	 	Inventory Control 

  

	 	•	 	Facility and Equipment Controls 

  
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 Refer to the Quality Agreement Responsibility Table in Exhibit C for outlined responsibilities in
each of the above systems. 
  

	6.	Issue Resolution 

 In the event that a quality dispute arises between Rovi and Emergent
concerning any Product(s) or services provided, the resolution shall proceed in the following stages: 
 Stage 1—Emergent’s and
Rovi’s Quality Assurance shall communicate directly to determine the facts of the matter and to produce an investigation report. This report shall contain complete details of the problem together with any discussion and conclusions. This stage
may involve engaging in third party testing. 
 Stage 2—The senior quality personnel from both parties shall discuss the issue and
resolution. 
 Stage 3—If a third party is used to perform confirmatory testing or an evaluation; both parties shall be advised of the
reported results. 
  

	7.	List of Exhibits 

 Exhibit A—Quality Contacts 

Exhibit B—Product/Material and Site List 

Exhibit C—Quality Agreement Responsibility Table 

Exhibit D—Glossary of Terms 

Exhibit E—Revision History 
  

	8.	References 

  

	 	•	 	21CFR11, 210, 211, 

  

	 	•	 	EU Volume 4 

  

	 	•	 	USP and EP Pharmacopeia, most current version 

  

	 	•	 	ISO 9001 Quality Management Systems, most current version 

 Exhibit A: Quality Contacts 

The following are the Contact Persons from each party that will be responsible for communications related to this agreement: 

  
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 Rovi Representatives 

 

					
		  	Primary Contact	  	Alternate Contact
	Name:	  	Ana Sanchez Otero	  	[**]
	Title:	  	Quality Director	  	Qualified Person
	Company:	  	Rovi contract Manufacturing, S.L.
	Address:	  	Julian Camarillo 35
	Phone:	  	[**]	  	[**]
	Fax:	  	NA	  	NA
	E-mail:	  	[**]	  	[**]

 Emergent Representatives 
  

					
		  	Primary Contact	  	Alternate Contact
	Name:	  	Minerva Devera, DBA, QSM	  	[**]
	Title:	  	Director, Quality Assurance, Regulatory Affairs, and Validation	  	Manager, Technical Quality Systems and Regulatory Affairs
	Company:	  	Cangene bioPharma, Inc. doing business as Emergent BioSolutions
	Address:	  	1111 South Paca Street ‘Baltimore, MD 21230 USA
	Phone:	  	[**]	  	[**]
	Fax:	  	[**]	  	[**]
	E-mail:	  	[**]	  	[**]

  
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 Exhibit B: Product/Material and Site List 

The following is the complete list of Product(s) and all facilities used by Rovi for manufacturing, storing, handling, distributing, packaging/re-packaging,
labeling/re-labeling, inspection/re-inspection, testing and release activities as well as any third party sites that perform any of these activities. 

This list is current as of March 1, 2014 and will be updated as necessary to reflect the business agreement between Emergent and Rovi. 

 

									
	 Name
	  	 Address
	  	City State /
Province	  	Postal/Zip
Code.
Country	  	 Supply Chain Function

	 Rovi part number S1250 Injectable Water 5mL EST ROCM

	Rovi Contract Manufacturing S.L.	  	Julian Camarillo, 35	  	Madrid, Spain	  	28037	  	Manufacturing/Processing, Testing, and Release of Water for Injection
	Subcontracted Services	  		  		  		  	
	[**]	  	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  	[**]	  	[**]
	[**]	  	[**]	  	[**]	  		  	[**]

 Note: This exhibit may be updated as required and any change in the supply chain and distribution channel requires prior
notification and approval of the Quality Agreement signatories. 
  

			
	  
	  	  

	Signature (for Cangene bioPharma doing business as Emergent BioSolutions)	  	Date
		
	 /s/ Ana Sanchez Otero
	  	 June 29, 2014

	Signature (for Rovi Contract Manufacturing S.L.)	  	Date

  
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 Exhibit C: Quality Agreement Responsibility Table 

 

							
	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	 Compliance
	  		  		  	
				
	Conform to the quality criteria defined in Section 3 of this Agreement.	  	X	  		  	
				
	Define specifications for the Product(s) which are the subject of this agreement, in addition to specifications related to the actual Product(s), Emergent’s specifications may include packaging materials, pallets, storage
conditions, etc.	  	X	  		  	
				
	Changes to the agreed upon specifications will be communicated in writing prior to implementation, except for required compendial changes which can be implemented without prior notification. Compendial changes must be implemented by
the compendial implementation date.	  	X	  	X	  	
				
	Ensure that the specifications for compendial Product(s) are in compliance with the current compendia.	  	X	  	X	  	
				
	Rovi Drug Master File [DMF] #25234 shall be made available through the issuance of a DMF Letter of Authorization [LOA] to Emergent. The LOA shall be reissued to Emergent each time updates or changes are made to the Rovi DMF.	  	X	  		  	
				
	Manufacture and Supply Product(s) that conform to the defined specifications.	  	X	  		  	
				
	Upon request, disclose to Emergent recent regulatory agency inspections and findings pertaining to the Product(s).	  	X	  		  	
				
	Notify promptly if, in the course of a regulatory inspection, negative findings are made related to the quality of the Product(s) supplied.	  	X	  	X	  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Shall have a process in place for qualification of third parties used for manufacturing, storing, handling, distributing, packaging/re-packaging, labeling/re-labeling, inspection/re-inspection, testing and release or processing the
Product(s) in any manner, which could be reviewed during an audit.	  	X	  		  	
				
	Rovi shall employ qualified staff as is necessary for the performance of its obligations under this Agreement.	  	X	  		  	
				
	Rovi will follow written and approved procedures for their activities.	  	X	  		  	
				
	Emergent may request to be on site during the processing of its Product(s). Arrangements for this shall be made in advance and shall be mutually acceptable for both parties. This person shall adhere to Rovi standard operating
procedures and policies.	  	X	  		  	
				
	Regulatory and Environmental Compliance	  		  		  	
				
	Rovi shall promptly report to Emergent any and all information that is reported to them relating to any adverse experience relating to the use of Product.	  	X	  		  	
				
	If Rovi is notified that the Product or Product manufacturing facility will be subject to an inspection by any Governmental Authority, Rovi will notify Emergent within [**] business days after receipt of such notice.	  	X	  		  	
				
	Rovi will promptly send to Emergent a copy of any inspection report observations [redacted], issued by a Governmental Authority, that relate to the manufacture, generation, processing, testing, storage, treatment, or other
management of the Product, as well as those observations that are of a general nature relating to the Product manufacturing facility.	  	X	  		  	
				
	Emergent shall have the opportunity to review and contribute to any response that Rovi prepares, that is directly related to Product, prior to the response being submitted.	  	X	  	X	  	
				
	A copy of Rovi responses [redacted] to any inspection observations, relating to Product, shall be promptly sent to Emergent once approved.	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	A copy of the Governmental Authority’s acceptance of Rovi responses shall be forwarded to Emergent upon receipt of same.	  	X	  		  	
				
	Establish and maintain an effective Pest Control Plan	  	X	  		  	
				
	Refrain to manufacture, process or store any Critical Compounds in the same building where Products are Manufactured or stored	  	X	  		  	
				
	Processing, Packaging and Labeling	  		  		  	
				
	MANUFACTURER shall Manufacture the Product(s) in full compliance with the requirements of the DMF, including without limitation the Manufacturing processes and testing monographs (including the Specifications and testing
methods	  	X	  		  	
				
	MANUFACTURER shall submit the master batch record to Emergent for review and approval prior to Manufacture of the first batch of Product(s).	  	X	  	X	  	
				
	 Document that manufacturing and packaging process are fit for purpose.

Demonstrate the commissioning of critical systems and equipment used in the manufacture and control of the Product(s).

 
 Demonstrate that cleaning procedures are appropriate and their effectiveness has been
demonstrated.
	  		  		  	
				
	Rovi shall retain samples of the Product(s) for a period of [**] years from the date of Manufacture.	  	X	  		  	
				
	Adequate retained sample program shall be established. Finished Product(s) samples will be retained for each batch/ lot of Product(s) manufactured.	  	X	  		  	
				
	Rovi shall provide prior notification to Emergent of any lot(s)/ batch(es) that have been reworked in a manner that is not consistent with Rovi’s validated manufacturing process that are designated for shipment to
Emergent.	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Emergent reserves the right to accept or refuse Product(s) that have not been produced in conformance with Rovi’s validated manufacturing process prior to delivery.	  		  	 X
	  	
				
	Rovi shall provide lot traceability information to Emergent upon request. This information is available for onsite review.	  	X	  		  	
				
	Rovi shall have adequate procedures in place to avoid mix-up of Product(s).	  	X	  		  	
				
	Rejected Product shall be disposed of in controlled manner to prevent re-use.	  	X	  		  	
				
	Rovi shall maintain traceability of a Product(s) during manufacturing operations.	  	X	  		  	
				
	Lot number of the Product(s) shall reflect one continuous production run.	  	X	  		  	
				
	Rovi shall have validated maximum hold times for critical control points indentified throughout the processing flow.	  	X	  		  	
				
	Rovi shall use adequate inspection of the Product(s).	  	X	  		  	
				
	Rovi shall implement adequate sampling plans, to control in-process materials.	  	X	  		  	
				
	Documentation and Records	  		  		  	
				
	Rovi shall follow Good Documentation Practices.	  	X	  		  	
				
	Certificate of Analysis shall be supplied with each batch.	  	X	  		  	
				
	 Certificate of Analysis shall be prepared with the Approval of Quality Unit Designate and shall contain:

 

•       Material code/part number and name

 

•       Lot number

 

•       Actual numerical specification or specification range, where
applicable
  

•       Reference to internal product specification or specification file
number and/or name
  

•       Specification revision number and/or date

 

•       Statement of Compliance to USP and EP requirements Site address of
manufacture
  

•       Date of manufacture
	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Where applicable, electronic signatures used on the Certificates of Analysis must conform to the requirements of 21CFR11.	  	X	  		  	
				
	Records required by the agreed upon quality system shall be maintained for a period of [**] years from date of manufacture of the Product(s).	  	X	  		  	
				
	Storage and Distribution	  		  		  	
				
	Maintain and supply upon request validation and/or stability documentation that supports the actual recommended storage and transportation conditions plus recommended retest interval and/or expiration date.	  	X	  		  	
				
	Ensure that Product(s) are stored and shipped in accordance with required and documented conditions and Emergent’s requirements.	  	X	  	X	  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Change Control	  		  		  	
				
	 Changes, impacting DMF registered information, will be initiated and evaluated by Rovi and communicated to Emergent based upon agreed
criteria and a timeline of not less than [**] day prior to proposed implementation. This Agreement does not specifically permit any Product or Process changes or deviations without Emergent’s documented consent. A copy of the Rovi Change
Control and Client Change Notification SOPs shall be appended to this agreement.
  
 Some
Examples of Notifiable Change include, but are not limited to:
  

•       Site of Manufacture

 

•       Scale of Manufacture

 

•       Equipment

 

•       EU Regulatory requirements applicable to any aspect of Product
fulfillment
  

•       Process

 

•       Internal Specifications impacting Product or starting materials.

 

•       Chemical Properties

 

•       Physical Properties

 

•       Functionality

 

•       Bioburden

 

•       Packaging and Labeling (including changes to primary packaging)

 

•       Product specifications including starting materials

 

•       Composition of any starting material [material of construction]

 

•       Source of any starting material

 

•       Force majeure impacting ability to manufacture
	  	X	  		  	
				
	 Any Notification of Change, at minimum, must be e-mailed to:
  

[**]
	  	X	  		  	
				
	Emergent is responsible for initiating any changes in conjunction with any applicable US Laws and will work closely with Rovi, as necessary, to ensure timely compliance prior to the effective date.	  		  	X	  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Changes to the Purchasing Specification are the responsibility of Emergent.	  		  	X	  	
				
	Non-Conformance	  		  		  	
				
	All non-conformances shall be investigated. Where applicable, this includes the identification of the root cause, a risk analysis (including the risk to other lots and the impact to other test results) of the actions taken for
correction of the problem, prevention of future occurrence and the formal conclusion by Rovi’s Quality Assurance. If an investigation reveals that there is an impact to Product(s) received by Emergent, Rovi shall inform Emergent promptly so as
to provide as much advance notice as possible.	  	X	  		  	
				
	Out-of-Specification (OOS)	  		  		  	
				
	Out-of-Specification (OOS) tests results shall be investigated and documented according to a documented procedure.	  	X	  		  	
				
	Deviations and CAPA	  		  		  	
				
	If significant deviations from an established process are recorded, there must be evidence of suitable investigations and a review of the quality of the Product(s).	  	X	  		  	
				
	Inform Emergent of any critical deviation during the manufacturing of a particular batch of Product(s).	  	X	  		  	
				
	Define effective corrective and preventive actions to ensure root cause are fully solved.	  	X	  		  	
				
	Complaints	  		  		  	
				
	Rovi shall have a written procedure to investigate and document quality related complaints. A root cause analysis, actions taken for correction of problem, prevention of future occurrence and the formal conclusion will be provided
to Emergent within [**] working calendar days from a receipt of notification about nonconforming Product(s) from Emergent.	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Complaints made by Emergent shall at least indicate Rovi’s batch number of the Product(s) and complaint subject. The complaint shall be communicated to Rovi within [**] calendar days of detection. Samples will be provided where
appropriate and available.	  		  	X	  	
				
	The parties shall cooperate in the exchange of information required to effectively conduct an investigation.	  	X	  	X	  	
				
	Recalls	  		  		  	
				
	In the case of a recall of the Product, Emergent and Rovi CM shall inform each other promptly so as to provide as much advance notice as possible.	  	X	  	X	  	
				
	Have a written recall procedure.	  	X	  	X	  	
				
	The parties shall cooperate in the exchange of information required to effectively conduct a recall or recall investigation.	  	X	  	X	  	
				
	Auditing	  		  		  	
				
	Emergent has the right to audit Rovi’s facilities, systems and documentation, as they relate to the manufacturing, storing, distributing, packaging, labeling, testing, releasing and handling of Product(s), at mutually agreed
upon times, not more than one compliance audit every [**] years. An audit deemed “For cause” by -Emergent, will be allowed at any time as mutually agreed upon and will not count against the biennial audit. All “For Cause” audits
must be linked to the triggering event. The scope of the “For Cause” audit shall be focused on the events associated with the Deviation or Complaint.	  		  	X	  	
				
	Allow Emergent to audit facilities, systems and documentation, as they relate to the manufacture of
Product(s), at mutually agreed upon times.	  	X	  		  	
				
	If required, a confidentiality agreement will be executed within a reasonable period of time prior to the audit or other exchange of information.	  	X	  	X	  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Emergent shall issue a confidential written audit report to Rovi, which will include audit observations, within [**] calendar days from the audit date.	  		  	X	  	
				
	Rovi shall issue responses within [**] calendar days to all observations in writing to Emergent Quality Assurance designee. Where Rovi commits to a corrective action, a description and timeframe for completion will be included in
the written response.	  	X	  		  	
				
	Where applicable, agree upon requirements for auditing third parties used in association with Product(s) production, processing, warehousing, or testing.	  	X	  	X	  	
				
	Training	  		  		  	
				
	Rovi shall have a written training program to ensure that each person engaged in the manufacture, processing, storing, packaging, labeling, distributing, testing, releasing or holding of a product used for injection shall have
education, training and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice as they
relate to the employee’s functions. Training shall be conducted by qualified individuals on a regular basis and with sufficient frequency to assure that employees remain familiar with internal processes and CGMP requirements.	  	X	  		  	
				
	Lot Disposition	  		  		  	
				
	Prior to release of any batch of product/material, Rovi shall ensure all required testing is complete and results are within specifications and that any associated non-conformances have been closed.	  	X	  		  	
				
	Stability Program	  		  		  	
				
	Rovi shall perform On-going stability testing to establish to comply with GMP ([**] per year and additional if any critical manufacturing problem arise)	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Raw Materials and Packaging Materials	  		  		  	
				
	Prepare specifications	  	X	  		  	
				
	Approve specifications	  	X	  		  	
				
	Vendor selection, qualification, and approval	  	X	  		  	
				
	Provide prior notification to Emergent of changes to source material vendors	  	X	  		  	
				
	Procurement of starting materials from qualified and approved vendors.	  	X	  		  	
				
	Subcontracting	  		  		  	
				
	MANUFACTURER agrees not to subcontract or delegate any portions of its obligations under this Quality Agreement or the Manufacturing and Supply Agreement, except to an Approved Subcontractor as listed in Exhibit B	  	X	  		  	
				
	Validation, Calibration and Maintenance	  		  		  	
				
	Facilities	  	X	  		  	
				
	Calibration	  	X	  		  	
				
	Equipment	  	X	  		  	
				
	Analytical Method Validation	  	X	  		  	
				
	Cleaning	  	X	  		  	
				
	Process	  	X	  		  	
				
	Computer	  	X	  		  	
				
	Rovi shall maintain records of routine and non-routine maintenance including calibration.	  	X	  		  	

  
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	 RESPONSIBILITIES
	  	 Rovi
	  	 Emergent
	  	 Not
Applicable

	Inventory Control	  		  		  	
	Rovi shall have an inventory control system in place (electronic or physical) that can effectively manage material movement from quarantine to release or rejected status to ensure that materials are handled appropriately.	  	X	  		  	
				
	Facility and Equipment Controls	  		  		  	
				
	Rovi shall ensure Product(s) are manufactured and handled in an environment that is suitable for the level of cleanliness required for manufacturing and handling the Product.	  	X	  		  	
				
	Shall ensure that adequate facility security controls are in place that only authorized personnel have access to Rovi facilities.	  	X	  		  	
				
	APR	  		  		  	
				
	Provide at Emergent cost an annual Product Quality Review (PQR)/Annual Product Review (APR) for Product(s) that 1 summarizes the regulatory filings, manufacturing history, information on quality, deviations, complaints, change
control, stability, validation, trending, process capability, conclusions and other items related to the manufacture of Product(s).	  	X	  		  	

  
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 Exhibit D: Glossary of Terms 

Note: Not all glossary terms may be used in a specific Quality Agreement depending on the material or service provided. 

Audit – A systematic and independent examination of manufacturing related activities and documents to determine whether these activities comply
with all internal policies and procedures as well as with all applicable governmental requirements. 
 Audit Report – Written documentation of
audit findings and observations. Additionally, the audit report may summarize the recommendations and any corrective or preventative follow-up activities. 

Bioburden – The nature and quantity of microorganisms present in the product. 

Certificate of Analysis – A document listing the test methods, specification and results of testing a representative sample from the batch to be
delivered 
 Change Control Procedure – A written procedure that describes the action to be taken if a change is proposed to facilities,
materials, equipment, and/or processes used in the fabrication, packaging and testing of drugs or that may affect the operation of the quality or support system. 

Chemical Property – A quality parameter that is measured by chemical or physiochemical test methods. 

Complaints – Any written, electronic, or oral communication that alleges deficiencies related to the identity, durability, quality, safety or
effectiveness of the material/product. 
 Corrective Action – A change implemented to address a weakness identified in a management system. 

Critical – A process step, process condition, test requirement or other relevant parameter or item that must be controlled within predetermined
criteria to ensure that the product meets its specification. 
 Customer – The organization receiving the product(s) once it has left the
control of the Product(s) manufacturer; including brokers, agents and users. 
 Date of Manufacture – A date indicating the completion of the
final manufacturing process (as defined by the manufacturer for the particular product and process). 
 Date of Retest – The date when retesting
is performed by a supplier to extend the length of the time the material may be used. 
 Deviation – Departure from an approved instruction or
established standard. 
 Distributor – All parties in the distribution/supply chain starting from the point at which a product is transferred
outside the control of the original manufacturer’s material management system including parties involved in trade and distribution, (re ) processors, (re )packagers, transport and warehousing companies, forwarding agents, brokers, traders, and
suppliers other than the original manufacturer. 

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 19 of 22 

 Electronic Signature – Means a computer data compilation of any symbol or series of symbols executed,
adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (CFR Part 11) 

Excipient – Any substance other than the active pharmaceutical ingredient or drug product which has been appropriately evaluated for safety and is
included in a drug delivery system to either aid the processing of the drug delivery system during manufacture, protect, support or enhance stability, bioavailability, or patient acceptability, assist in product identification, or enhance any other
attribute of the overall safety and effectiveness of the drug delivery system during storage or use. 
 Functionality – The set of performance
criteria the product is intended to meet. 
 GDP–Good Distribution Practice—GDP deals with the distribution of Product(s), including
requirements for purchase, receiving, storage and export. GDP regulates the movement of Product(s) from the premises of the manufacturer to the end user, or to an intermediate point by means of various transport methods. 

GMP–Good Manufacturing Practice—Requirements for the quality system under which certain Product(s) and their ingredients are
manufactured. To ensure that Product(s) are consistently produced and controlled to the quality standards appropriate to their use. Current Good Manufacturing Practice (CGMP) is the applicable term in the United States. For the purposes of this
agreement, the terms GMP and CGMP are equivalent, 
 Impurity – Any component of a product that is not the intended entity but is present as a
consequence of either the starting materials used or the manufacturing process. 
 IPEC – International Pharmaceutical Excipients Council 

ISO – International Organization for Standardization. 

Manufacturer – A party who performs the final processing step. 

Manufacturing Process – All operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release
and storage of Product(s) and related controls. 
 Non conforming Material – Material that does not meet the manufacturer’s specifications
or has not been manufactured according to applicable GMP’s. 
 Physical Property – A quality parameter that can be measured solely with
mechanical equipment. 
 Procedure – Written, authorized instruction for performing specified operations. 

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 20 of 22 

 Quality Agreements – Legally binding agreements that are mutually negotiated between users and
suppliers. They are intended to be an agreement between quality departments. A quality agreement is intended to be a formalized, joint agreement on quality responsibilities and activities defining both the users and suppliers respective obligations
as they relate to quality. They are intended to address quality commitments between the parties and are based on the quality procedures in place. 

Quality Assurance – The sum total of the organized arrangements made with the object of ensuring all Product(s) are of the quality required for
their intended use and that quality systems are maintained. 
 Quality Representative – Authorized individual(s) identified by the company as
the official(s) directly responsible for quality assurance and compliance through which the release of each product/material is performed. Individuals must have the appropriate qualifications, education, training and experience to perform their
duties. 
 Recalls – A process for withdrawing or removing a product from the distribution chain because of defects in the materials or
complaints of a serious nature. The recall might be initiated by the manufacturer/importer/distributor or a responsible agency. 
 Record –
Document stating results achieved and/or providing evidence of activities performed. The medium may be paper, magnetic, electronic or optical, photography etc. or a combination thereof. 

Relabelling – The process of putting a new label on the material. 

Repackaging – The action of changing the packaging of the material. 

Re-packaging – Transfer of an excipient from one container to another. 

Reprocessing – Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and
repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation, filtration, chromatography, milling) that are part of the established manufacturing process. Continuation of a process step after an
in-process control test has shown that the step is incomplete is considered to be part of the normal process, and not reprocessing. 
 Retained
Sample – Representative sample of a batch/delivery that is sufficient quantity to perform at least 2 full quality control analyses and will be kept for a defined period of time. 

Reworking – Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are
different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). 

Scale – An increase of decrease in the batch size in batch processing or the throughput capability for continuous processing whether or not
different equipment is used. 

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 21 of 22 

 Site – A location where the product is manufactured. This may be within the facility but in a
different operational area or at a remote facility including a contract manufacturer. 
 Significant Change – A change that alters a Product(s)
physical or chemical property outside the limits of normal variability or that is likely to alter the product performance in the dosage form. 

Specification – The quality parameters to which the product, component or intermediate must conform and that serve as a basis for quality
evaluation. 
 Standard Operating Procedure (SOP) – A written procedure giving instructions for performing operations not necessarily specific
to a given product or material but of a more general nature (e.g., equipment operation, maintenance and cleaning; validation; cleaning of premises and environmental control; sampling and inspection). Certain SOPs may be used to supplement product
specific master and batch production documents. 
 Storage and Transportation Conditions – Pre-determined specification ranges for maintaining
product/material quality. 
 Supply Chain – For the purpose of this agreement, supply chain includes all aspects of the product, from the
acquisition of starting materials to use of the finished product by the end user. 
 Supplier – Person or company providing pharmaceutical
starting materials on request. Suppliers may be distributors, manufacturers, traders, etc. A manufacturer or distributor who directly provides the product to the user. 

User – A party who utilizes a product in the manufacture of a drug product or another excipient. 

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 22 of 22 

 Exhibit E: Revision History 
  

					
	 Revision No.
	  	 Date Approved
by Emergent
	  	 Reason for Change

	Original	  		  	

  
 Rovi Contract Manufacturing S.L. –
SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY 
 Page 23 of 22 

					
	 N° Documento: PC-031/14-00

Fecha: 22.04.2014
	  	 AIQ/AOQ SISTEMA TESTO

INFORME DE NO
 CONFORMIDADES /

DESVIACIONES
	  	Pág. __ de __

 10 INFORME DE NO-CONFORMIDAD / DESVIACIÓN 

Número de No 
 Conformidad/Desviación: 

N° Test / Fase (AIQ-AOQ): 
  

					
	Descripción de la No Conformidad / Desviación:
		
	Análisis y Acción correctora:	  	
			
	Realizado por:	  	  
	  	  

		  	Firma	  	Fecha
			
	Aprobado por:	  	  
	  	  

		  	Firma	  	Fecha

  

					
	Conclusión y Cierre:
			
	Realizado por:	  	  
	  	  

		  	Firma	  	Fecha
			
	Aprobado por:	  	  
	  	  

		  	Firma	  	Fecha

 Realizado por:
                                         
                                    Fecha:
                                         
        
  

			
	Proyecto: Validación de Sistema Testo (RC-005/2014)	  	Página 13 de 21EX-10.27

 Exhibit 10.27 

Confidential Materials omitted and filed separately with the 

Securities and Exchange Commission. Double asterisks denote omissions. 

MANUFACTURING SERVICES AGREEMENT 
 THIS
MANUFACTURING SERVICES AGREEMENT (the “Agreement”) is made as of May 27, 2015 (the “Effective Date”) between  

PATHEON UK LIMITED, a corporation existing under the laws of England (“Patheon”)  

and 
 CNJ HOLDINGS INC., doing business as Emergent
BioSolutions, a corporation existing under the laws of Manitoba, Canada (“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: 
 Capitalized terms used in this Agreement shall have the meanings ascribed to them in Schedule A (Definitions) or as
set out below.  
  

	1.	Services:  

  

	 	(a)	Services. Patheon agrees to perform, at the Manufacturing Site, the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required
to manufacture Product using the Active Materials and Components as better described in Patheon’s Proposal Ref. N°. C-FEP-83755-R0, attached hereto as Schedule B (“Services”), in the Quality Agreement (attached
hereto as Schedule E) and in the following terms and conditions of this Agreement. 

 Patheon will perform Services for
the Territory for the fees specified in Schedule C to manufacture Product for Client and in such quantities as required by Client from time to time in accordance with Schedule D of this Agreement. 

 

	 	(b)	Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon. If Patheon manufactures Product in accordance with the agreed upon internal process
specifications, the Specifications, the batch production record, cGMP, the Quality Agreement, and Patheon’s standard operating procedures for manufacturing, and a batch or portion of batch of Product does not meet a finished product
Specifications, Client will, (provided such non-conformance is not caused by Patheon’s breach of this Agreement), pay Patheon the applicable price per unit for the non-conforming Product. 

  
 Page 1 of 73 

	2.	Payments  

 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 1(d) of Schedule D hereto. Each invoice will, to the extent applicable, identify Client’s
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 invoices within [**] days of the date thereof. If any portion of an invoice is disputed, the
Client will pay Patheon for the undisputed amount and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Interest on undisputed past due accounts will accrue at [**]% per month which is equal to an
annual rate of [**]%. 
  

	3.	Supply of API and Components/Equipment: 

  

	 	(a)	Active Materials and Client-Supplied Components. Client will deliver, at least [**] days before the scheduled production date (or such shorter period as may be agreed upon by the parties in writing), the Active
Materials (and Client-Supplied Components, if any) to the Manufacturing Site DDP (Incoterms 2010), at no cost or risk to Patheon, with VAT paid by Client, if any, in sufficient quantity to enable Patheon to manufacture the desired quantities of
Product and to ship Product on the agreed delivery date (the “Delivery Date”). If the Active Materials and/or Client-Supplied Components, if any, are not received at least [**] days before the scheduled production date, Patheon may
delay the shipment of Product by the same number of days as the delay in receipt of the Active Materials and/or Client-Supplied Components. 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, and provided that Patheon will use its good faith efforts to schedule the Services as soon as reasonably practical taking into account
Client’s requested delivery date. 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. 

  

	 	(b)	 Damage/Discrepancies. Within [**] Business Days following Patheon’s receipt of the Active Materials
and Client-Supplied Components, Patheon shall inform Client of any damage to the materials received that is visually obvious (e.g., damaged or punctured containers, integrity of pallets and cartons). Patheon will perform analytical testing on the
Active Materials (and Client-Supplied Components, if any) in accordance with the Specifications and the Quality Agreement, and will inform Client within [**] Business Days from discovery thereof of (i) any failure of Active Materials and
Client-Supplied Components to 

  
 Page 2 of 73 

	 	
conform to the Specifications, which is detectable by Patheon by performing the analytical testing according to the Quality Agreement; or (ii) any discrepancy in identity or quantity
actually received versus the packing list and/or the delivery note. In the event such deficiency/discrepancy in the Active Materials and Client-Supplied Components causes Patheon to fail to meet its obligations under this Agreement, Patheon shall be
excused from performance to the extent Patheon did not cause such deficiency and such deficiency adversely affects Patheon’s performance under this Agreement. 

 

	 	(c)	Patheon and the Client will reasonably cooperate to permit the import of the Active Materials to the Manufacturing Site. Client’s obligation will include obtaining the proper release of the Active Materials from
the applicable Customs Agency and Regulatory Authority. Client or Client’s designated broker will be the “Importer of Record” for Active Materials imported to the Manufacturing Site. Title to the Active Materials will at all times
remain the property of Client. The Active Materials will be held by Patheon on behalf of Client as set forth in this Agreement, the Specifications provided by Client, the Quality Agreement, and with Applicable Laws, including without limitation
cGMPs. Patheon shall be responsible and liable for the proper care, handling, and storage of Active Materials in accordance with Specifications provided by Client, the Quality Agreement, and with Applicable Laws, including without limitation cGMPs,
such responsibility to commence upon receipt at the Manufacturing Site and end upon delivery of Product by Patheon as specified in this Agreement. Without limiting the generality of the foregoing, Patheon will handle and store all Active Materials
in a manner so as not to intermingle Active Materials with any other substances or risk contamination. If any Active Material is lost, damaged or contaminated following delivery to the Manufacturing Site, including due to Patheon’s failure to
perform the Services in accordance with this Agreement, Patheon shall, subject to the limitations on liability set forth in Section 6.C.(d) below, reimburse Client within [**] days after the applicable calendar quarter for the replacement cost
of such materials, or at Client’s option, shall credit Client such replacement cost against future invoices for the Product owing hereunder. Any Active Materials received by Patheon will only be used by Patheon to perform the Services.

  

	 	(d)	If Client asks Patheon to qualify an additional source for the Active Material or any Component, Patheon will, at Client’s cost, utilize appropriate change control procedures as identified in the Quality Agreement
to evaluate the Active Material or Component to be supplied by the additional source to determine if it is suitable for use in the Product. The parties will mutually agree upon the scope of work to be performed by Patheon at Client’s cost.
Section 1(b) of the Agreement will apply to all Product manufactured using the newly approved Active Material or Component because of the limited material characterization that is performed on additional sources of supply. 

  
 Page 3 of 73 

	 	(e)	Components. Patheon will purchase and test all Components (with the exception of Client-Supplied Components) at Patheon’s expense and as required by the Specifications. 

 

	 	(f)	If any capital equipment expenditures are required to perform the Services, and such equipment is to be exclusively dedicated to the Product, the rights and obligations of the parties and the ownership and use of the
equipment will be addressed in a separate agreement between the parties. 

  

	4.	Term, Termination:  

  

	 	4.1	Initial Term. 

 This Agreement will become effective as of the Effective Date and
will continue for three (3) years (the “Initial Term”), unless terminated earlier by one of the parties in accordance herewith. This Agreement will automatically renew 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. 
  

	 	4.2	Termination for Cause. 

  

	 	(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 90 days following receipt of a written notice (the “Remediation Period”) of the breach that expressly states that it is a notice under this Section 4.2(a) (a “Breach Notice”). The aggrieved
party’s right to terminate this Agreement under this Section 4.2(a) may only be exercised for a period of 60 days following the expiry of the Remediation Period (where the breach has not been remedied) and if the termination right is not
exercised during this period then the aggrieved party will be deemed to have waived the breach of the representation, warranty, or obligation described in the 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 upon 30 days’ prior written notice if any Authority takes any action, or raises any objection, that prevents Client from importing, exporting, purchasing, or selling the Product.
But if this occurs, Client must still fulfill all of its obligations under Section 4.4 below. 

  
 Page 4 of 73 

	 	(d)	Patheon may terminate this Agreement upon six months’ prior written notice if Client assigns under Section 10A 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 Patheon Competitor; or (iii) an entity with whom Patheon has had prior unsatisfactory business relations, as jointly discussed in good faith with the Client.

  

	 	4.3	Product Discontinuation 

 Client may terminate this Agreement on at least twelve
(12) months’ notice if it intends to no longer order Services for a Product due to this Product’s discontinuance in the market. 
  

	 	4.4	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, at the price in effect at the time the Firm Order was placed; 

 

	 	(b)	Client will purchase, at Patheon’s cost (including all reasonable 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 or in accordance with Schedule D, Section 1(d), unless such Inventory can be, with Client’s written approval, used by Patheon in the manufacture of product for Patheon’s
other customers; 

  

	 	(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 or in accordance with Schedule D, Section 1(d),
and provided such orders are non-cancellable (if the orders may not be cancelled without penalty, the same will be assigned to and satisfied by Client); 

  

	 	(d)	Client acknowledges that no Patheon Competitor will be permitted access to the Manufacturing Site; 

  
 Page 5 of 73 

	 	(e)	Except for termination by Patheon under Section 4.2(a), (b) and (d), at Client’s request, Patheon shall evaluate, in its reasonable discretion, if it can continue to manufacture Products for Client and
its Affiliates until such time as Client has successfully transitioned manufacture of the Products to an alternate supplier; For sake of clarity, if Patheon, acting reasonably, does not intend to continue the supply of Product, as per the above
provisions, Patheon shall not be obliged to do so; 

  

	 	(f)	If requested by Client and if agreed between the Parties, Patheon shall provide reasonable assistance to Client, at Client’s sole reasonable cost on a time and materials basis, to (i) assist Client in the
transfer of relevant manufacturing technology and information to an alternate supplier’s manufacturing facility, (ii) participate in teleconferences with Client in connection with the transfer, and/or (iii) provide requested
documentation to Client, at Client’s sole cost, in order to effectuate such transition. 

  

	 	(g)	Subject to Section 4.4(e) above, Client will make commercially reasonable efforts, at its own expense, to remove from Patheon site(s) within [**] Business Days following the completion, termination, or expiration
of the Agreement) all unused Active Material and Client-Supplied Components, all applicable Inventory and Materials (whether current or obsolete), supplies, undelivered Product, chattels, 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 fails to remove the Client Property within the required period specified above, Client will pay
Patheon storage fees as set forth in Schedule C, Section 4, 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 2 of this Agreement. 

  

	5.	Inventions; Intellectual Property:  

  

	 	(a)	For the term of this Agreement, Client hereby grants to Patheon and its Subcontractor a limited, non-exclusive, paid-up, royalty-free non-transferable, non-sub-licensable save to Patheon’s permitted sub-contractors
license of Client’s Intellectual Property which Patheon must use in order and solely for Patheon to perform the Manufacturing Services. The foregoing license shall terminate immediately upon termination or expiry of this Agreement.

  

	 	(b)	All Intellectual Property generated or derived by Patheon while performing the Services, to the extent it is specific to, or dependent upon, the development, manufacture, use, and sale of Client’s Product that is
the subject of the Services, will be the exclusive property of Client. Patheon hereby assigns to Client, all right, title and interest in and to any and all Intellectual Property generated or developed by Patheon while performing any 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 to the extent effective in advance, and where not effective shall promptly do and
ensure that its representatives do all acts and sign all documents necessary to perfect Client’s right, title and interest in and to such Intellectual Property as shall be reasonably requested by Client, at Client’s expense.

  
 Page 6 of 73 

	 	(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, transferable, license to use the Patheon
Intellectual Property used by Patheon to perform the Manufacturing Services in connection with the Product(s). 

  

	 	(d)	Each party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions. 

 

	 	(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. 

  

	 	(f)	Subject to Subsections above of this Section 5, 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. 

  

	6.	Indemnity: 

  

	 	A.	Indemnification by Client 

 Client agrees to defend and indemnify Patheon, its Affiliates
and their officers, employees, and agents against all losses, damages, costs, expenses (including reasonable attorneys’ fees), claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting
from, or relating to any claim of infringement or alleged infringement of any third party rights, including any claim of infringement or alleged infringement of any intellectual property rights of third parties, in the Products, in the performance
of Services, on the Specifications, or any portion thereof (except to the extent such claim is subject to Patheon’s indemnity obligations pursuant to Section 6B), or any claim of personal or bodily injury or property damage to the extent
that the injury or damage is the result of a breach of this Agreement by Client, including, without limitation, any representation or warranty contained herein, except to the extent that the losses, damages, costs, claims, demands, judgments, and
liability are due to the negligence or wrongful act(s) of Patheon, its officers, employees, or agents and provided however that for the purposes of this Section 6.A, any Client’s warranty contained herein shall be read without giving
effect to any knowledge qualifier. 

  
 Page 7 of 73 

 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, provided, however, that 

  

	 	(i)	Patheon may join in the defense and settlement of such claim or proceeding and employ counsel at its own expense; and 

  

	 	(ii)	Client may not settle any claim or proceeding without Patheon’s written consent, unless such settlement includes a release of all covered claims or proceedings pending against Patheon, contains no admission of
liability or wrongdoing by Patheon, and imposes no material adverse obligations upon Patheon. 

  

	 	B.	Indemnification by Patheon 

 Patheon agrees to defend and indemnify Client, its
Affiliates to whom rights under this contract have been assigned in accordance with Section 10A, and their respective officers, employees, and agents against all losses, damages, costs, expenses (including reasonable attorneys’ fees),
claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting from, or relating to (i) any claim of personal or bodily injury or property damage to the extent that the injury or damage is the
result of a failure by Patheon to perform the Services in accordance with the Specifications, cGMPs, the Quality Agreement and/or Applicable Laws except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due
to the negligence or wrongful act(s) of Client, its officers, employees, agents, or Affiliates; (ii) a breach of Patheon’s confidentiality obligations under the Confidentiality Agreement provided under Section 10F; and/or
(iii) any infringement or alleged infringement of a third party’s Intellectual Property rights due to Patheon’s breach of its warranties under Section 7.B(d), provided however that for the purposes of this Section 6.B.(iv),
the warranty referenced shall be read without giving effect to any knowledge qualifier. 
  

	 	C.	Limitation of Liability 

  

	 	(a)	 Defective Product. Client has the right to reject the whole or any portion of any lot of Products that
deviates from the Specifications, cGMPs, the Quality Agreement, or Applicable Laws without invalidating any remainder of the lot. Client will inspect the Products manufactured by Patheon upon receipt and will give Patheon written notice (a
“Deficiency 

  
 Page 8 of 73 

	 	
Notice”) of all claims for Products that deviate from the Specifications, cGMPs, the Quality Agreement, or Applicable Laws within [**] days after Client’s receipt thereof (or, in the
case of any defects not reasonably susceptible to discovery upon receipt of the Product, within [**] days after discovery by Client, but not after the expiration date of the Product). Should Client fail to give Patheon the Deficiency Notice within
the applicable [**] day period, then the delivery will be deemed to have been accepted by Client on the [**] day after delivery or discovery, as applicable. Patheon will have no liability for any deviations for which it has not received notice
within the applicable [**] day period. 

  

	 	(b)	If Client rejects Products in accordance with the provisions above of Section 6C(a) and the deviation is determined to have arisen from Patheon’s failure to provide the Services in accordance with the
Specifications, cGMPs, the Quality Agreement, or Applicable Laws, then Client’s sole remedy will be to request Patheon to: 

  

	 	•	 	repeat that part of the Service at Patheon’s costs, if Client supplies the Active Material and Client-Supplied Components; 

  

	 	•	 	offset the amount paid against other amounts due to Patheon hereunder; or 

  

	 	•	 	reimburse Client for the price for that part of the Service. 

 If Patheon is unable to replace
the returned Products, then Patheon will reimburse Client for the price that Client paid to Patheon for Services for the affected Products and for the replacement cost of the Active Materials and Client-Supplied Components incorporated into the
defective Products, subject to the limitation of liability specified in Section 6C(d). In all other circumstances, returns or other corrective actions will be made at Client’s cost and expense. 

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 this Section 6C(a-b-c). In all other circumstances, Client will bear the cost of disposition, including all applicable fees for Services, for any damaged, defective, returned, or Recalled Products. 

 

	 	(c)	 Recalled/Returned Product. If a Recall or return results from, or arises out of, a failure by Patheon to
perform the Services in accordance with the Specifications, cGMPs, the Quality Agreement, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will, at Patheon’s expense and at
Client’s option, 

  
 Page 9 of 73 

	 	
either replace the Recalled or returned Products with new Products, contingent upon and within [**] calendar days of the receipt from Client of all Active Materials and Client-Supplied Components
required for the manufacture of the replacement Products, or reimburse Client for the price that Client paid to Patheon for Services for the affected Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in
Recalled Product will be subject to the limitation of liability specified in Section 6.C.(d). In all other circumstances, Recalls, returns, or other corrective actions will be made at Client’s cost and expense. 

To the extent replacement Product is provided by Patheon pursuant to Section 6.C.(b) or (c) above, such replacement batches shall
[**]. 
  

	 	(d)	Active Material liability. Under no circumstances whatsoever will Patheon reimburse Client for the cost of the Active Material except if the loss of Active Material occurs because of Patheon’s negligence or
willful misconduct. In any event, and subject to Section 6C(a) above, Patheon’s maximum responsibility for loss or damage to the Active Materials will not exceed in the aggregate in any Year 10% of revenues in said Year to Patheon
pursuant to this Agreement. 

  

	 	(e)	Maximum Liability. Except in respect of liability arising under Section 6B in respect of indemnity for third party claims or under the Confidentiality Agreement dated 19th March 2013 for breach of the confidentiality obligations therein provided, Patheon’s maximum liability to Client under this Agreement for any reason whatsoever, including, without
limitation, any liability arising or resulting from any and all breaches of its representations, warranties, or any other obligations under this Agreement will not exceed in the aggregate for all claims in any Year 10% of revenues in said Year to
Patheon pursuant to this Agreement. 

  

	 	(f)	For the sake of clarity, Patheon’s maximum aggregate liability to Client for any obligation to (i) refund, offset or replace any defective Product under Section 6.C(b) or replace any recalled Products
under Section 6.C(c), will not exceed 100% of the Price for the defective or recalled Product as applicable. This Section 6.C(f) shall not be subject to Section 6.C(e). 

 

	 	(g)	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) any other liability, damage, cost or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of the damages. This
Subparagraph 6C(e) shall not apply to damages due to a party’s breach of its confidentiality obligations under Subparagraph 10F (Confidentiality). 

  
 Page 10 of 73 

	 	(h)	Death, Personal or Bodily Injury and Fraudulent Misrepresentation. Nothing contained in this Agreement shall act to exclude or limit either party’s liability for personal or bodily injury, death, or
fraudulent misrepresentation caused by the negligence of either party. 

  

	 	D.	Sole Remedy 

 Except for the indemnity set forth in Section 6B (Indemnification by
Patheon) and subject to the limitations set forth in Section 6C (Limitation of Liability), the remedies described in Section 6C and in Section 4.2 (Termination for Cause) will be Client’s sole remedies for any failure by Patheon
to provide the Services in accordance with the Specifications, cGMPs, and Applicable Laws. For the avoidance of doubt, the remedies described in Section 6C and Section 4.2 (Termination for Cause) are to be cumulative and not in lieu of
other remedies provided by those Articles. 
  

	7.	Warranties 

  

	 	A.	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)	to the best of Client’s knowledge and belief, any Client Intellectual Property, used by Patheon in performing the Services according to the Specifications (A) is Client’s or its Affiliate’s
unencumbered property or is exclusively licensed to Client, and (B) may be lawfully used as directed by Client; 

  

	 	(iii)	the performance of the Services by Patheon for any Product under this Agreement, except for any Patheon Intellectual Property rights used therefor, and/or to the best of Client’s knowledge and belief, the
use or other disposition of any Active Materials or Product by Patheon as may be required to perform its obligations under this Agreement, does not infringe any valid and enforceable third party Intellectual Property rights;. 

  
 Page 11 of 73 

	 	(iv)	as of the Effective Date, to the best of Client’s knowledge and belief, there are no actions or other legal proceedings, concerning the infringement of third party Intellectual Property 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)	the Products, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws (i) may be lawfully used, sold and distributed in every jurisdiction in
which Client markets the Products; in accordance with the relevant Marketing Authorization, and (ii) will be sold by Client in a safe and responsible manner. 

 

	 	(iii)	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. 

  

	 	B.	Patheon Warranties. 

 Patheon covenants, represents, and warrants that: 

 

	 	(a)	it will perform the Services in accordance with the Specifications, cGMPs, the Quality Agreement, and Applicable Laws; 

  

	 	(b)	all Product, upon delivery EXW at the Facility to Client or to a party of Client’s designation, shall (i) fully conform to the applicable Specifications and release information; (ii) have been
manufactured in compliance with the applicable regulatory requirements, cGMPs, the Specifications, the Quality Agreement, and all Applicable Laws; and (iii) not be adulterated or misbranded within the meaning of any Applicable Law;

  

	 	(c)	Patheon has, and shall use commercially reasonable efforts to maintain the resources and personnel necessary to fully perform its obligations under this Agreement in a timely manner; and without limiting Patheon’s
personnel training and qualification obligations under the Quality Agreement (as applicable), any individual used by Patheon to perform the Services are, and will continue to be, qualified and have, and will continue to have, sufficient technical
expertise to perform Patheon’s obligations under this Agreement; 

  
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	 	(d)	to the best of Patheon’s knowledge and belief, any Patheon Intellectual Property used by Patheon or its Affiliates to perform the Services (i) is Patheon’s or its Affiliate’s unencumbered property,
(ii) may be lawfully used by Patheon and its Affiliates, and (iii) does not infringe and will not infringe any third party rights in the Territory. 

  

	 	C.	No warranty. NEITHER PARTY MAKES ANY WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. NEITHER PARTY MAKES ANY WARRANTY OR
CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE PRODUCTS. 

  

	8.	Cooperation 

  

	 	(a)	Quarterly 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 quarterly to review the current status of the business relationship and manage any issues that have arisen. 

  

	 	(b)	Governmental Agencies. Subject to Section 8(h), 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.

  

	 	(c)	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, in accordance with the Quality Agreement. Client is responsible for retaining samples of the Products necessary to comply
with the legal/regulatory requirements applicable to Client, in accordance with the Quality Agreement. 

  

	 	(d)	Inspection. Client, and/or Client officially authorised representatives under express duty of confidentiality to Patheon and upon prior written consent of Patheon, such consent not to be unreasonably withheld,
conditioned, or delayed, may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, and on dates mutually acceptable to the parties, but a Patheon representative must be
present during the inspection. 

  
 Page 13 of 73 

	 	(e)	Access. Patheon will give Client, and/or officially authorised Client representatives under express duty of confidentiality to Patheon and upon prior written consent of Patheon, such consent not to be
unreasonably withheld, conditioned, or delayed, reasonable access at agreed 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, the Quality Agreement, and Applicable Laws. But, with the exception of “for-cause” audits, or as otherwise provided for in the Quality Agreement, Client will be limited each
Year to [**], lasting no more than [**] days, 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 as set
out in Schedule C, Paragraph 5. The right of access set forth in this Section 8(e) will not include a right to access or inspect Patheon’s financial records. 

 

	 	(f)	Notification of Regulatory Inspections. Patheon will permit Regulatory Authorities to inspect its facilities and otherwise cooperate fully with Regulatory Authorities in connection with the approval process and
continuing registration and/or licenses for Products. Patheon will notify Client of any inspections scheduled by any governmental agency in accordance with the terms and conditions of the Quality Agreement. Patheon will also notify Client within
[**] (or as otherwise indicated in the Quality Agreement), 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. For clarity, the fees set forth in Section 8(e) relating to additional audits shall not apply to audits by Regulatory Authorities pursuant to this Section 8(f). 

 

	 	(g)	Reports. Patheon will supply on an annual basis all Product data in its control, including without limitation release test results, complaint test results, and all investigations (in manufacturing, testing, and
storage), processing related technical records, and any other data generated or obtained by Patheon in connection with this Agreement, that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including
without limitation any annual report that Client is required to file with the FDA or reports that Client is required to file with other Regulatory Authorities. At Patheon’s request, Client will provide a copy of the relevant sections of the
Annual Product Review Report to Patheon at no cost. Any data requested by Client pursuant hereto may be subject to an additional fee to be agreed upon between Patheon and the Client; provided however, that such fee shall not exceed Patheon’s
standard fee then in effect for such services. For the avoidance of doubt, the obligations of confidentiality set forth in Section 10.F. below shall not prevent Client from disclosing information provided hereunder to Regulatory Authorities as
may be required to obtain or maintain product approvals. 

  
 Page 14 of 73 

	 	(h)	Regulatory Filings: Starting from the date of execution of this Agreement, in respect of all future documentation, prior to filing with the Regulatory Authority any documentation which is or is equivalent to the
FDA’s Chemistry and Manufacturing Controls (“CMC”) portion of the New Drug Application or of the Abbreviated New Drug Application, Client will give Patheon a copy of the CMC portion relevant to Patheon’s Services, as well
as all supporting documents which have been relied upon to prepare such CMC portion. This disclosure will permit Patheon to verify that the CMC portion accurately describes the Services that Patheon has performed and the manufacturing processes that
Patheon will perform under this Agreement. Patheon requires [**] days to perform this review but the parties shall agree to a shorter time for the review to the extent required to meet regulatory deadlines. If Client does not give Patheon the
documents requested 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 reasonable discretion, delay or postpone any inspection by the
Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents. 

  

	 	(i)	Recall/Return of Product. 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 by
telephone (to be confirmed in writing) 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. Client will have the responsibility for handling customer returns of Product. Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and
regulations. 

  

	 	(j)	Manufacturing Site, Operations. With respect to its overall operations or the Manufacturing Site, (i) to the best of its knowledge and belief, Patheon shall, during the Term, be in material compliance with
Applicable Laws; (ii) Patheon has not received any warning letters or other similar communication related to the Manufacturing Site or its operations from or on behalf of a governmental agency, relating directly or indirectly to the manufacture
of the Product; and (iii) any deficiencies noted or otherwise referenced in any Form FDA-483 issued to Patheon have been corrected, or communicated in writing to Client, prior to the Effective Date. 

  
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	9.	Shipping: 

 Shipments of Products will be made EXW (Incoterms 2010) Patheon’s
shipping point. Risk of loss or of damage to Products will remain with Patheon until Patheon loads the Products onto the carrier’s vehicle for shipment at the shipping point at which time risk of loss or damage will transfer to Client. Patheon
will, in accordance with Client’s instructions and as agent for Client, at Client’s risk, arrange for shipping to be paid by Client. 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. 
  

	10.	Miscellaneous: 

  

	 	A.	Assignment and Subcontracting 

 Patheon may not assign this Agreement or any of its
associated rights or obligations without the written consent of Client, this consent not to be unreasonably withheld. The parties acknowledge that Patheon may arrange for subcontractors to perform specific testing services arising under this
Agreement without the consent of Client. Further it is specifically agreed that Patheon may subcontract the Services under this Agreement to its Affiliate, Patheon [**], (“Subcontractor”), provided however, that all Services shall
be performed at the Manufacturing Site. Client will have a right of access to the Subcontractor’s Manufacturing Site for auditing purposes, in accordance with the terms and conditions set out in Section 8. The subcontracting of any
Services hereunder to the Subcontractor by Patheon shall not relieve Patheon of, and Patheon shall remain solely liable for, its obligations under this Agreement. Subject to Section 4.2(d), Client may assign this Agreement or any of its
associated rights or obligations without approval from Patheon. Client will give Patheon prior written notice of any assignment and any assignee will covenant in writing with Patheon to be bound by the terms of this Agreement. 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 12 months’ prior written notice to Client and the assignee if good faith discussions do not lead to
agreement on amended Service fees within a reasonable time. Despite the foregoing provisions of this Section 10A, 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. If the assignee Affiliate is not deemed credit worthy by Patheon, acting reasonably, then Patheon may require Client to
enter into a parent company guarantee of assignee’s obligations hereunder as a pre-condition to such assignment. For purposes of this Agreement, “Affiliate” means an entity controlling, controlled by or under common control
with another entity, where control is defined as ownership, directly or indirectly, of more than 50% of the voting rights in the entity. 

  
 Page 16 of 73 

	 	B.	Force Majeure 

 Except for payment obligations, neither party will be responsible for
delay or failure in performance resulting from acts beyond the reasonable control and without the fault or negligence of the party, including, but not limited to, strikes or other labour disturbances, lockouts, quarantines, communicable disease
outbreaks, riots, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, defective equipment not caused by lack of recommended maintenance, lack of or inability to obtain fuel, power or components or compliance
with any order or regulation of any government entity. 
  

	 	C.	Survival 

 Any termination or expiration of this Agreement will not affect any
outstanding obligations or payments due hereunder prior to such termination or expiration, nor will it prejudice any other remedies that the parties may have under this Agreement. The Confidentiality Agreement and Sections 2 (Payments) (to the
extent such payments became due and payable prior to the termination or expiration), 4.4 (Obligations on Termination), 5 (Inventions, Intellectual Property), 6 (Indemnity and Limitations), 7 (Warranties), 8 (Cooperation) (i.e. to the extent such
provisions by their nature survive expiration or termination), 9 (Shipping), 10C (Survival), 10O (Choice of Law) and 10F (Confidentiality), Schedule A (as relevant), Schedule C (Section 1, Section 2.1(b), Section 2.3, Section 4,
Section 7), Schedule D (Payments due under Section 3 to the extent such payments became due and payable prior to the termination or expiration) of the Agreement will survive the expiration or termination of this Agreement. 

 

	 	D.	Independent Contractors 

 The parties are independent contractors and this Agreement will
not be construed to create between Patheon and the 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. 

 

	 	E.	Permits 

 Without prejudice to Patheon’s obligations under the following provisions
of this Section 10E, Client will be solely responsible for obtaining or maintaining, prior to any distribution or marketing of the Products or at all relevant times, 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 its own expense (save as set out in this Agreement), at all relevant times all governmental permits, licenses, approval, and
authorities required to enable it to lawfully and properly perform the Services. 

  
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	 	F.	Confidentiality 

 The Confidentiality Agreement entered into between Cangene Corporation
(an Affiliate of CNJ Holdings Inc.) and Patheon on 19th March 2013 will apply to all confidential information about the parties (and their Affiliates) and the Services to be conducted under
this Agreement and the Confidentiality Agreement is deemed to be incorporated herein by reference. If the Confidentiality Agreement expires or terminates prior to the expiration or termination of this Agreement, then the terms of the Confidentiality
Agreement will nonetheless continue to govern the parties’ obligations of confidentiality for the term of this Agreement and for five years thereafter. 
  

	 	G.	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. 
  

	 	H.	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, 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. 
  

	 	I.	Insurance 

 Each party will maintain during the term of this Agreement general liability
and product liability insurance. Either party may request evidence of this insurance. 
  

	 	J.	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. 
  

	 	K.	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: 

  
 Page 18 of 73 

 If to Client : 
  

● 
 Attention: General
Counsel 
 CNJ Holdings Inc. 

c/o Emergent BioSolutions Inc. 

400 Professional Drive, Suite 400 

Gaithersburg, MD 20879 
 With a
copy to: 
 Attention: Legal Affairs 

CNJ Holdings Inc. c/o Emergent BioSolutions 

155 Innovation Drive, Winnipeg, MB, Canada R3T 5Y3 • 

Telecopier No.: [**] 
 If to
Patheon: 
 Patheon UK Limited 

Kingfisher Drive 
 Covingham 

Swindon Wiltshire SN3 5BZ 

England 
 Attention: Legal
Director 
 Facsimile No: [**] 
  

	 	L.	Entire Agreement. 

 This Agreement is the complete agreement between the parties for this
subject matter and supersedes all other prior agreements and understandings, whether written or oral. Any modifications, amendment or supplement to this Agreement must be in writing, expressly intending to vary the terms of this Agreement, and
signed by authorized representatives of both parties. The terms and conditions of this Agreement may not be varied by the terms of Client’s purchase order. 
  

	 	M.	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, because each provision is separate, severable, and distinct.

  

	 	N.	Facsimile. 

 This Agreement may be signed in counterparts and by facsimile or by
“pdf.” 

  
 Page 19 of 73 

	 	O.	Choice of Law. 

 This Agreement is governed by the laws of the State of New York, without
regard to any conflicts-of-law principle that directs the application to another jurisdiction’s laws. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement. The parties hereby irrevocably submit to
the exclusive jurisdiction of the courts within the State of New York for all matters related to this Agreement. 
  

	11.	Schedules 

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

Schedule B—Patheon Proposal Ref. n. C-FEP-83755-R0 

Schedule C—Fees and Adjustments to Fees 

Schedule D—Orders and Forecast, Minimum Order Quantity, Annual Yearly Value 

Schedule E—Quality Agreement 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]     

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

			
	PATHEON UK LIMITED
		
	By:	 	 /s/ Mark Newton

	Name:	 	Mark Newton 28 May 2015
	Title:	 	Dir EU BDS
	
	CNJ HOLDINGS INC. d/b/a Emergent BioSolutions
		
	By:	 	 /s/ Sean M. Kirk

	Name:	 	Sean M. Kirk 27 May 2015
	Title:	 	SVP, Operations
	
	 Finance Approved
 /s/ illegible

May 26, 2015

  
 Page 21 of 73 

 Schedule A 

Definitions 
 “Active
Material” “Active Pharmaceutical Ingredients” or “API” means coagulation factor IX (recombinant) drug substance; 

“Active Material Value” means value of the Active Materials for certain purposes of this Agreement, as set forth in a separate letter
to be provided by Client to Patheon prior to the execution of this Agreement; 
 “Actual Yearly Value” or
“AYV” means the value of Services ordered and purchased by Client in any Year of this Agreement as set forth in Schedule D; 

“Applicable Laws” means (i) for Patheon, the Laws of the jurisdiction where the Manufacturing Site is located; 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 (a) federal, state, provincial, local, municipal, foreign or other government; (b) governmental or
quasi-governmental authority of any nature (including any governmental agency, branch, department, official or entity and any duly authorized court or other tribunal, including an arbitral tribunal); (c) multi-national organization or body; or
(d) body exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police, regulatory, or taxing power of any nature. 

“Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the UK, [**], or Manitoba, Canada;

 “Binding Yearly Value” or “BYV” means the minimum contractual value of Services to be ordered and purchased
by the Client in any Year of this Agreement as set forth in Schedule D; 
 “Breach Notice” has the meaning set forth in
Section 4.2(a); 
 “cGMPs” means, as applicable, current good manufacturing practices as described in: 

 

	 	(a)	Division 2 of Part C of the Food and Drug Regulations (Canada); 

  

	 	(b)	Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations (“C.F.R.”) and the supplementary requirements for biologics set forth in Parts 600 to 680 of Title 21 of the C.F.R. (as
applicable); and 

  

	 	(c)	EC Directive 2003/94/EC, 

 together with the latest Health Canada, FDA, EMA, and International Conference on
Harmonization (ICH) guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time; 

  
 Page 22 of 73 

 “Client Intellectual Property” means Intellectual Property generated or derived by Client
before or after entering into this Agreement (including without limitation all information, documents, or materials containing Intellectual Property that Client provides to Patheon in connection with the performance of 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 4.4(g); 

“Client-Supplied Components” means those Components to be supplied by Client or that have been supplied by Client; 

“Components” means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product
inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials; “Deficiency Notice” has the meaning set forth in Section 6C(a); 

“Delivery Date” has the meaning set forth in Section 3(a); 

“Effective Date “ has the meaning set forth of the first page of the Agreement; 

“Firm Order” has the meaning set forth in Schedule D, Section 1(b); 

“Initial Term” has the meaning set forth in Section 4.1; 

“Intellectual Property” includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark
applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, know how, and any other intellectual property or proprietary rights recognized in any country or jurisdiction worldwide now or in the future; 

“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;  
 “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; 
 “Manufacturing Site” means the facility owned and operated by Patheon’s
Affiliate, Patheon [**]; 
 “Patheon Competitor” means a business that derives greater than 50% of its revenues from
performing contract pharmaceutical development or commercial manufacturing services; provided however, that Affiliates of Client shall be excluded from this definition;  

  
 Page 23 of 73 

 “Patheon Intellectual Property” means Intellectual Property (i) generated or derived
by Patheon before performing any manufacturing Services, or (ii) developed by Patheon while performing the manufacturing Services or otherwise generated or derived by Patheon in its business provided that (a) such Intellectual Property
does not arise from, is not based on or does not relate to Patheon’s use of Client Confidential Information or the Active Material or Product(s); (b) reasonably could be used by Patheon without revealing or disclosing any Client
Confidential Information; and (c) can be used for purposes not exclusively related to the Client Confidential Information, Active Material or Product(s), 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); 

“Product” means IXINITYTM; 

“Quality Agreement” means the agreement between the Parties that sets out the quality assurance standards for the Manufacturing
Services to be performed by Patheon for Client (Schedule E); 
 “Recall” means 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; 

“Regulatory Authority” means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing
approvals for pharmaceutical products, including the Products; 
 “Remediation Period” has the meaning set forth in Section
4.2(a); 
 “Services” has the meaning set forth in Section 1(b); 

“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 Product including material safety data sheets; 

  
 Page 24 of 73 

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

  

	 	(f)	quality control and quality assurance testing. 

 all as updated, amended and revised from time to time by
Client in accordance with the terms of this Agreement; 
 “Subcontractor” has the meaning set forth in Sections 10A;  

“Territory” means the geographic area of the United States of America and the twenty-eight Member States of the European Union or as
otherwise agreed by the Parties during the term of this Agreement. 
 “Year” means the 365-calendar day period from the
Effective Date. 

  
 Page 25 of 73 

 Schedule B 

Patheon Proposal Ref. N. C-FEP-83755-R0 

Manufacturing Assumptions: 
 [**] 

Packaging Assumptions: 
 [**] 

Testing Assumptions: 
 [**] 

The following cost items are included in the Price for the Products: 

[**] 

  
 Page 26 of 73 

 Schedule C 

Fees, Adjustments 
  

	1.	First Year Pricing. 

  

	 	•	 	Euro [**] per batch (without Components) 

  

	 	•	 	Euro [**] per batch (including Components) 

 “Price” means the price per batch of
Product, measured in EURO to be charged by Patheon for performing the Services, and, where stated, includes the cost of Components (other than Client-Supplied Components) and certain cost items as set forth in Schedule B, but excludes, for the sake
of clarity, the annual stability testing costs . 
 The tiered Price and annual stability Price for the Products for the first Year as set out in the table
above shall remain fixed throughout the term of this Agreement, subject to the adjustments expressly set forth in Section 2 below. 
 Unless otherwise
specifically stated in this Agreement, all monetary amounts to be paid by either party pursuant hereto are to be paid in EURO. 
  

	2.	Price Adjustments 

  

	2.1	Price Adjustments – Subsequent Years’ Pricing. 

  

	 	(a)	After the first Year, Patheon may adjust the Price effective January 1st of each Year as follows: 

 

	 	(i)	Manufacturing and Stability Testing Costs. Patheon may adjust the Price for inflation, based upon any increase in the Consumer Price Index, published by ISTAT in August of the preceding Year compared to
the final number for the same month of the Year prior to that, unless the parties otherwise agree in writing. This index is set forth at the following web address: http://www.istat.it/salastampa/comunicati/in_calendario/ precon/20110114_00/
the inflation. By no later than [**] of each Year, Patheon will give Client a statement setting forth the calculation for the inflation adjustment to be applied in calculating the Price for the next Year. 

 

	 	(ii)	Component Costs. If Patheon incurs an increase in Component costs during any given Year; Patheon may increase the Price for the next Year to pass through the additional Component costs. By no later than [**] of
each Year, Patheon will give Client information and supporting documentation about the increase in Component costs which will be applied to the calculation of the Price for the next Year and that reasonably demonstrates that the Price increase is
justified. As Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers, Patheon has the right to provide Client with redacted documentation as necessary to comply
with its confidentiality obligations vis-à-vis third parties. 

  
 Page 27 of 73 

	 	(iii)	Pricing Basis. Client acknowledges that the Price in any Year is quoted based upon the Minimum Order Quantity specified in Schedule D, Paragraph 2. If a change to the Minimum Order Quantity is requested by
Client, then Patheon will be entitled to an adjustment to the Price to compensate it for the increased costs, if any. For greater certainty, if Patheon and Client agree that the Minimum Order Quantity will be reduced and, as a result of the
reduction, Patheon demonstrates to Client that its costs to perform the Services or to acquire the Components for the Product will increase on a per unit basis (including the amount of the increase), then Patheon may increase the Price by an amount
sufficient to absorb the documented increased costs. By no later than [**] of each Year, Patheon will give Client a statement and supporting documentation setting forth the information to be applied in calculating those cost increases for the next
Year. As Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers, Patheon has the right to provide Client with redacted documentation as necessary to comply with
its confidentiality obligations vis-à-vis third parties. 

  

	 	(b)	Termination Right for Pricing Adjustments. For all Price adjustments under this Section 2.1, Patheon will deliver to Client on or about [**] (and in any event, no later than [**]) of each Year a revised
Table for Schedule C to be effective for Product delivered on or after the first day of the next Year. If the pricing adjustments, in the aggregate, permitted to be made under this Agreement (including without limitation this Article 2) with respect
to the Price for the Product in any Year exceed the then-current Price by more than [**] percent (+[**]%), then the Parties shall negotiate in good faith the price adjustments. If the Parties, acting reasonably and in good faith, do not reach an
agreement on the price adjustments within [**] months from the date on which Client receives written request of a Price adjustment from Patheon, then either Party will have the right to terminate the Agreement by providing the other Party with a
written notice of termination. Such written notice of termination, if any, must be delivered within thirty (30) days following the expiry of the said [**]-month period of the date on which Client receives notice of a Price adjustment that would
result in the foregoing [**] percent ([**]%) threshold being exceeded, and termination of the Agreement will be effective [**] months after the delivery of such written termination notice. If the Agreement is so terminated, then during the period
prior to termination, the Price for the Product in effect prior to such adjustment will prevail. 

  
 Page 28 of 73 

	2.2	Price Adjustments - Current Year Pricing. 

 During any Year, the Prices set out in
this Schedule C 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: (i) the cost of a Component increases by [**]% of the cost for that Component upon which the most recent fee quote was based; or (ii) the aggregate cost for all Components
required to manufacture a Product increases by [**]% of the total Component costs for the Product upon which the most recent fee quote was based. 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. 
 For
a Price adjustment under this Section 2.2, Patheon will deliver to Client a revised Table for this Schedule C and budgetary pricing information, adjusted Component costs or other documents reasonably sufficient to demonstrate that a Price
adjustment is justified. As Patheon will not be required to give information to Client that is subject to obligations of confidentiality between Patheon and its suppliers, Patheon has the right to provide Client with redacted documentation as
necessary to comply with its confidentiality obligations vis-à-vis third parties. The revised Price will be effective for any Product delivered on or after the first day of the month following Client’s receipt of the revised Schedule C.

  

	2.3	Adjustments Due to Technical Changes. 

 Amendments to the Specifications, to any
manufacturing/packaging requirements (including the analytical methods) and/or to the Quality Agreement requested by Client will only be implemented following a technical and cost review, and are subject to Client and Patheon reaching agreement on
Price changes required because of the amendment. The parties shall use good faith efforts to agree upon any such increase or decrease in the Price and the date for implementation of any such amendment. Amendments to the Specifications, to any
manufacturing/packaging requirements, the Quality Agreement, and/or to the Manufacturing Site requested by Patheon, shall only be implemented: (i) following the written approval of Client, the approval not to be unreasonably withheld; and
(ii) utilizing appropriate change control procedures as identified in the Quality Agreement. If Client accepts a proposed Price change (i.e. in respect of an amendment implemented pursuant to this Section 2.3, requested by Client), the
proposed change in the Specifications will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Products that are manufactured/packaged under the revised Specifications. In addition, in respect
of Inventory or Components subject to an amendment requested by Client, (a) Client agrees to purchase, at Patheon’s cost (including all reasonable costs incurred by Patheon for the purchase and handling of the Inventory), all Inventory
used under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 1(d) of Schedule D, provided that the Inventory can no longer be used under the revised Specifications, or

  
 Page 29 of 73 

 
used by Patheon in the manufacture of product for Patheon’s other customers; and (b) 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 1(d) of Schedule D will be cancelled where possible, and if the orders may not be cancelled without penalty, will be assigned to and satisfied by Client. 

 

	2.4	Multi-Country Packaging Requirements. 

 If Client decides to have Patheon perform
Manufacturing Services for the Product for countries outside of 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
costs for Components (other than Client-Supplied Components) and the changeover 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. 
  

	3.	Intentionally Omitted. 

  

	4.	Storage Fees. 

 Storage Fees: € [**] per pallet, per month for storing the Components or
finished Product 
 Storage Fees: for Components or Product which contain controlled substances or require refrigeration will be charged at €[**] per
pallet per month. Storage fees are subject to a [**] minimum charge per month. 
  

	5.	Audit. 

 Fees for additional audits as per Section 8(e): €[**] for each additional audit
day and €[**] per audit day for each additional auditor. 
  

	6.	Annual Stability Testing 

 Patheon and Client will agree in writing on any stability testing to be
performed by Patheon on the Products. The said agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing. 

 

	7.	Taxes. 

  

	 	(a)	The Client will bear all taxes, duties, levies and similar charges (and any related interest and penalties) (“Tax” or “Taxes”), however designated, imposed as a result of the provision by the Patheon
of Services under this Agreement, except: 

  

	 	(i)	any Tax based on net income or gross income that is imposed on Patheon by its jurisdiction of formation or incorporation (“Resident Jurisdiction”); 

  
 Page 30 of 73 

	 	(ii)	any Tax based on net income or gross income that is imposed on Patheon by jurisdictions other than its Resident Jurisdiction if such tax is based on a permanent establishment of Patheon; and 

 

	 	(iii)	any Tax that is recoverable by Patheon in the ordinary course of business for purchases made by Patheon in the course of providing its Services, such as Value Added Tax (“VAT”, as more fully defined in
subparagraph (d) below), Goods & Services Tax (“GST”) and similar taxes. 

  

	 	(b)	If the Client is required to bear a tax, duty, levy or similar charge pursuant to this Agreement by any state, federal, provincial or foreign government, including, but not limited to, Value Added Tax, the Client will
pay such tax, duty, levy or similar charge and any additional amounts to the appropriate taxing authority as are necessary to ensure that the net amounts received by Patheon hereunder after all such payments or withholdings equal the amounts to
which Patheon is otherwise entitled under this Agreement as if such tax, duty, levy or similar charge did not exist. 

  

	 	(c)	Patheon will not collect an otherwise applicable tax if the Client’s purchase is exempt from Patheon’s collection of such tax and a valid tax exemption certificate is furnished by the Client to Patheon.

  

	 	(d)	If subparagraph 7 (a)(iii) above does not apply, any payment due under this Agreement for the provision of Services to the Client by Patheon is exclusive of value added taxes, turnover taxes, sales taxes or similar
taxes, including any related interest and penalties (hereinafter all referred to as “VAT”). In the event that any VAT is payable on a Service supplied by Patheon to the Client under this Agreement, this VAT will be added to the invoice
amount and will be for the account of (and reimbursable to Patheon by) the Client. If VAT on the supplies of Patheon is payable by the Client under a reverse charge procedure (i.e., shifting of liability, accounting or payment requirement to
recipient of supplies), the Client will ensure that Patheon will not effectively be held liable for this VAT by the relevant taxing authorities or other parties. Where applicable, Patheon will use its reasonable commercial efforts to ensure that its
invoices to the Client are issued in such a way that these invoices meet the requirements for deduction of input VAT by the Client, if the Client is permitted by law to do so. 

 

	 	(e)	Any Tax that Client pays, or is required to pay, but which Client believes should properly be paid by Patheon pursuant hereto may not be offset against sums due by Client to Patheon whether due pursuant to this
Agreement or otherwise. 

  
 Page 31 of 73 

 Schedule D 

Orders and Forecasts, Minimum Order Quantities, Annual Yearly Volumes 

 

	1.	Orders and Forecasts.  

  

	 	(a)	Rolling [**] Month Forecast. When this Agreement is executed, subject to Section 1(b) and Section 3 below, Client will give Patheon an initial non-binding [**] month forecast of the volume of
Product that Client expects to order in the first [**] months of commercial manufacture of the Product by Patheon. Each monthly forecast shall be sent to Patheon by email. This monthly forecast will then be updated by Client on or before the [**]
day of each month on a rolling forward basis. Client will update the monthly forecast forthwith if it determines that the volumes estimated in the most recent forecast have changed by more than +/-[**]. Within [**] Business Days of receipt of each
forecast, Patheon shall provide Client with a non-binding feasibility opinion of Patheon’s ability to meet such forecast. If for any reason Patheon is, or reasonably believes that it may be, unable to deliver the quantity of Product identified
in a forecast, Patheon shall promptly notify Client. The most recent [**] month forecast will prevail. Each Forecast shall be made in number of batches. 

  

	 	(b)	Firm Orders. On a rolling basis during the term of this Agreement, Client will issue, consistent with Subparagraph (a) above, an updated [**] month forecast on or before the [**] day of each month. This
forecast will start on the first day of the next month. The first [**] months of this updated forecast will be considered binding firm orders. Concurrent with the [**] month forecast, Client will issue a new firm written order in the form of a
purchase order or otherwise (“Firm Order”) by Client to purchase and when accepted by Patheon pursuant to Section 1(c) below (such acceptance not to be unreasonably withheld), for Patheon to manufacture and deliver the agreed
quantity of the Products identified for the first [**] months of the most recent forecast. The delivery date will not be less than [**] days following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify
Client’s purchase order number, quantities of batches by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. Subject to the exceptions expressly provided for
in this Agreement, the quantities of Products ordered in those written orders will be firm and binding on Client and may not be changed by Client. 

  

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

  
 Page 32 of 73 

	 	(d)	Acceptance of Firm Order. Patheon will accept Firm Orders by sending an acknowledgement to Client within [**] Business Days of its receipt of the Firm Order. The acknowledgement will include, subject to
confirmation from the Client, the Delivery Date for the Product ordered. However, if Patheon, acting reasonably, needs to change the proposed delivery date by more than [**] weeks or to vary the volumes therein provided, then Patheon shall promptly
notify the Client thereof and the parties shall negotiate in good faith a delivery date and a volume which are reasonable for both parties. The Delivery Date, as agreed between the parties in accordance with this Section 1(c), may be amended by
agreement of the parties or as set forth in Section 3 (a) of the Agreement. 

  

	 	(e)	Reliance by Patheon. 

 Client understands and acknowledges that Patheon will rely on the
Firm Orders and rolling forecasts submitted under Subparagraphs 1(a) and 1(b) above in ordering the Components (other than Client-Supplied 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 periods referred to in Subparagraph 1(a) above 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 Services requirements for Products for the first [**] months contemplated in the most recent forecast
given by Client under Subparagraph 1(a) above. Patheon may make other purchases of Components to meet 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. Unless caused by improper action or inaction of Patheon, if Components ordered by Patheon under Firm Orders or this
Subparagraph (d) are not included in finished Products manufactured for Client within [**] months 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 or have an insufficient remaining shelf life to use in the Product, then Client will pay to Patheon its actual costs therefor (including all reasonable 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.

 If Client fails to take possession or arrange for the destruction of Components within [**] months of purchase or, in the case of finished
Product, within [**] months of manufacture (or [**] days from Parties’ release provided that Client’s batch review and release of Product shall have to be completed within [**] weeks of manufacture), Client will pay Patheon storage fees
for storing the Components or finished Product as set forth in Schedule C, Section 4. Patheon may ship finished Product held by it longer than [**] months to the Client at Client’s expense on [**] days written notice to the Client. 

  
 Page 33 of 73 

	2.	Minimum Order Quantity 

 Client may only order Services for the Minimum Order Quantities as
indicated below. 
 Minimum Order Quantity: [**] or multiples thereof ([**] = [**] units) 

For the sake of clarity, Minimum Order Quantities means the minimum number of batches to be produced by Patheon during the same cycle of manufacturing. 

 

	3.	Annual Yearly Value. 

  

	 	(a)	Client agrees to purchase from Patheon, each Year during the Term of this Agreement, Services costing, in total, the lesser of (i) [**] Euros, per Year; or (ii) the price to be paid for [**] batches during
such Year if less than [**] Euros (the “Binding Yearly Value” or “BYV”). Client’s purchases from Patheon during 2015 prior to execution of this Agreement (and/or prior to the Effective Date of the Agreement) shall not count
towards the Binding Yearly Value purchase commitment for the first Year during the Term with the exception of the cGMP batches scheduled for manufacture during May / June 2015 (which shall count towards the Binding Yearly Value purchase commitment
for the first Year during the Term). Purchases for additional services from Patheon to Client or an Affiliate of Client, pursuant to a change of scope agreement, shall also count towards the Binding Yearly Value provided that any such purchases
occur subsequent to execution of this Agreement. 

  

	 	(b)	Patheon agrees to accept purchase orders from Client up to the maximum of [**] batches of Product per Year. Patheon agrees to make commercially reasonable efforts to accept purchase orders received from Client for
volumes of Product in excess of [**] batches of Product per Year, provided however, that the parties acknowledge that manufacturing dates in respect of such purchase orders must be mutually agreed upon by the parties and subject to the provisions
below of this Section 3(b). 

 “Commercially Reasonable Efforts” shall mean, with respect to
Patheon’s efforts to supply volumes of Product in excess of [**] batches per Year, that Patheon shall, at the request of Client, supply the additional volumes of Product as requested by Client only if, and to the extent that, at the time of
Client’ request, Patheon believes, acting reasonably and in good faith, that it has the relevant available capacity at the Manufacturing Site to meet such additional Product requirements without prejudice to its contractual and/or commercial
relationship vis-à-vis other clients. 
  

	 	(c)	The parties may change the Binding Yearly Value set forth in Section 3(a) above in a written amendment to this Agreement. [**] 

  
 Page 34 of 73 

 Notwithstanding the foregoing, Client shall not be responsible to make the foregoing payment to
the extent the amount invoiced by Patheon under Section 2 of the Agreement is less than the BYV solely as a direct result of Patheon’s failure to supply the agreed Services in accordance with the Specifications, cGMPs, the Quality
Agreement, or Applicable Laws. 

  
 Page 35 of 73 

 Schedule E 

Quality Agreement 

(copy to be attached prior to the commencement of any GMP 

manufacturing at the Manufacturing Site under this Agreement) 

  
 Page 36 of 73 

 

 
  
 QUALITY
AGREEMENT 
 Commercial Product 

Between 
 CNJ Holdings, Inc.

 c/o 155 Innovation Drive, 

Winnipeg, Manitoba, Canada R3T 5Y3 

(hereinafter referred to as “Contract Giver” or the “Customer”) 

-and-  
 Cangene
Corporation 
 c/o 155 Innovation Drive, 

Winnipeg, Manitoba, Canada R3T 5Y3 

(hereinafter referred to as “Cangene”) 

-and- 
 Patheon [**] 

([**] Operations) 
 [**]

 (hereinafter referred to as “Patheon” or the “Contract Acceptor”) 

Effective Date: The last date signature 

Version: QG01-05-T001-01 

  

					
	 Quality
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	  	Agreement	  	

 Page 1 of 37 

 

 
  
 TABLE OF CONTENTS 

 

					
	 GLOSSARY/DEFINITIONS
	  			
		
	 SECTION 1:  PREMISES AND AGREEMENT
	  	 	4	  
		
	 SECTION 2:  RESPONSIBILITIES TABLE
	  	 	6	  
		
	 SECTION 3:  GENERAL
	  	 	9	  
		
	 SECTION 4:  DESCRIPTION OF RESPONSIBILITIES
	  	 	10	  
		
	 SECTION 5:  APPENDICES
	  	 	27	  
		
	 APPENDIX A: PRODUCT(S)
	  	 	28	  
		
	 APPENDIX B: QUALITY CONTACTS
	  	 	29	  
		
	 APPENDIX C: PATHEON APPROVED VENDOR LIST
	  	 	31	  
		
	 APPENDIX D: CUSTOMER APPROVED VENDOR LIST
	  	 	32	  
		
	 APPENDIX E: PATHEON APPROVED CONTRACT LABORATORIES LIST
	  	 	33	  
		
	 APPENDIX F: CERTIFICATE OF ANALYSIS
	  	 	34	  
		
	 APPENDIX G: CERTIFICATE OF GMP COMPLIANCE
	  	 	35	  
		
	 APPENDIX H: API STARTING MATERIALS EU REQUIREMENTS
	  	 	37	  

  

					
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	  	Agreement	  	

 Page 2 of 37 

 

 
  
 GLOSSARY/DEFINITIONS 

Active Pharmaceutical Ingredient (API) shall mean any substance intended to furnish pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or animal. 
 Batch Record
shall mean the documentation needed to trace the complete cycle of manufacture of the Product from the receipt of all materials through all processing and subsequent packaging to dispatch for sale or supply to Cangene Batch record includes, but
is not limited to, the following main record types: batch production record, batch packaging record and batch quality control record. Quality control record includes quality control, quality assurance and environmental data specific to the batch.

 Facility shall mean either of Patheon manufacturing facility located in [**], or any other facility approved by Cangene for use by Contract
Acceptor in the Manufacture and Supply of Product. 
 Consumables shall mean any material used during production, coming to direct contact
with the Product, disposable, by default. 
 Change shall mean any change that might affect validated status, quality, regulatory compliance
or Cangene’s Product Quality Standard compliance. 
 Deviation shall mean any departure from SOPs, methods, specifications, protocols,
batch records, instructions, processes, process specifications or normal conditions (e.g. borderline conformances) or other official documentation. 

GMP or cGMP shall mean current Good Manufacturing Practices, as such term is defined in the United States Code of Federal Regulations parts 210, 211,
600, 601, 610, and the requirements thereunder imposed by the FDA, all promulgated and published, and in EC Directives 2003/94/EC and 2006/86/EC, Eudralex Vol. IV and all subsequent revisions, laying down the principles and guidelines of good
manufacturing practice for medicinal products, in each case as applicable to the circumstances. 
 GDP shall mean Good Distribution Practice,
and deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, import, storage, supply or export of active substances and drugs intended for
human use In general, it aims to verify the whole supply chain. 
 Manufacture, manufacturing or production shall mean any and all operations
to process, formulate, sterilize, compound, aseptic fill, lyophilize, label, test, handle, primary or bulk packaging, and warehousing of the Product at the facility, all in accordance with the agreed Manufacturing instructions, Specifications and
Standard Operating Procedures (SOPs). 
 Packaging materials shall mean all materials employed in the packaging of a Product, excluding any
outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary packaging materials according to whether or not they are intended to be in direct contact with the medicinal product and as bulk
packaging materials. 

  

					
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	  	Agreement	  	

 Page 3 of 37 

 

 
  
 Periodic Product Review shall mean a regular
comprehensive analysis of each Product’s manufacturing process, which includes a review of market performance (including customer complaints), the impact of process changes, quality events (process Deviations and audit findings) and adherence
to Specifications and standards. This review is conducted with annual frequency and is in line with EU (Eudralex Vol IV Part 1 Chapter I) and US (US 21CFR Part 211.180) regulations. 

Product shall mean product as designated in Annex 1 hereto. 

Product Quality Standard shall mean all mandatory aspects of the composition, manufacturing process, control methods and Specifications and Packaging,
which are essential to ensure safety, quality and efficacy of the Product. 
 Qualified Person or “QP” shall mean the person(s)
responsible for batch release, as defined in Article 48 of Directive 2003/94/EC. 
 Quality Agreement shall mean this Agreement, the Annexes,
and any amendment. 
 Raw materials shall mean all materials used in the manufacture of Product, except packaging materials, but including
consumables which are not present in the finished product (e.g. water, vial headspace gas). 
 Reference Samples shall mean samples of APIs,
Raw materials, Packaging materials, and the Product that are kept for possible re-examination. 
 Specifications shall mean the agreed
specifications for the Product and related Raw and Packaging materials. 
 SECTION 1: PREMISES AND AGREEMENT 

PREMISES. Under a Manufacturing Services Agreement (the “MSA”) dated May 27, 2015 between Patheon UK
Limited and the Customer, Patheon UK Limited agreed to sub-contract the performance of pharmaceutical manufacturing services for certain marketed products in certain countries (as set forth in Appendix A hereto) (“Products”) to
Patheon (also referred to herein as the “Contract Acceptor”). The parties agreed that Patheon UK Limited will remain solely liable to the Customer for any breach of the duties and responsibilities assumed by Patheon under this Agreement.
The Customer is required to give the Contract Acceptor certain Specifications in order for Patheon to perform the manufacturing services. Under the MSA, Patheon UK Limited is required to ensure that Patheon operates within the Specifications and in
accordance with cGMP. The Customer and Patheon, as provider of the manufacturing services on behalf of Patheon UK Limited for the benefit of the Customer, desire to allocate the responsibility for procedures and Specifications impacting on the
identity, strength, quality and purity of the Products by entering into this Quality Agreement (this “Agreement”). 

  

					
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	  	Agreement	  	

 Page 4 of 37 

 

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

  

					
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	  	Agreement	  	

 Page 5 of 37 

 

 
  
 SECTION 2: RESPONSIBILITIES TABLE 

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

 

							
	 Subject/Terms
	  	Cangene	  	Patheon
	4.1 Quality Management
	 4.1.1
	  	GMP, Health and Safety Compliance	  	(X)	  	X
	 4.1.2
	  	Customer Audit Rights	  	X	  	(X)
	 4.1.3
	  	Subcontracting	  	(X)	  	X
	 4.1.4
	  	Self-Inspection	  		  	X
	4.2 Regulatory Requirements
	 4.2.1
	  	Permits (Site licenses & GMP certificates (EU). Site Master File PIC)	  		  	X
	 4.2.2
	  	Product Licenses and Registration files life-cycle management	  	X	  	(X)
	 4.2.3
	  	Product permits: supply of all necessary approved registration information (CTD quality sections) and relevant updates	  	X	  	(X)
	 4.2.4
	  	Regulatory Compliance	  		  	X
	 4.2.5
	  	Components compliance documentation (BSE/TSE, Residual Solvents. API GMP, etc.)	  	X (materials
supplied)	  	X (materials
procured)
	 4.2.6
	  	Government Agency Inspections, Communications and Requisitions	  	(X)	  	X
	4.3 Material Control	  		  	
	 4.3.1
	  	Test Methods and Specifications	  	X	  	(X for Patheon
 local
requirements)

	 4.3.2
	  	Material Destruction	  	(X)	  	X
	 4.3.3
	  	Vendor Quality Management	  	X (materials
supplied)	  	X (materials
procured)
	 4.3.4
	  	Customer Supplied Materials In-coming Material Testing	  	X	  	(X)
	 4.3.5
	  	Patheon Supplied Materials Incoming Material Testing	  		  	X
	 4.3.6
	  	Incoming Material Release	  	X	  	X
	 4.3.7
	  	Storage and Transportation of Materials	  		  	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	  		  	X

  

					
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	4.5 Product Controls
	 4.5.1
	  	Test Methods and Specifications	  	X	  	(X)
	 4.5.2
	  	Master Batch Record	  	(X)	  	X
	 4.5.3
	  	Reprocessing and Rework	  	(X)	  	X
	 4.5.4
	  	Personnel and Training	  		  	X
	 4.5.5
	  	Container closure integrity test	  		  	X
	4.6 Packaging, Labeling and Printed Materials (Not Applicable)
	 4.6.1
	  	Master Batch Packaging Records (VOID)
	 4.6.2
	  	Printed Material and Artwork (VOID)	  		  	
	 4.6.3
	  	Test Methods and Method Validation (VOID)	  		  	
	4.7 Exception Reports (Deviations / Investigations)
	 4.7.1
	  	Manufacturing Instruction Deviations	  	(X)	  	X
	 4.7.2
	  	Packaging Instructions Deviations	  	(X)	  	X
	 4.7.3
	  	Notification of Deviations	  	(X)	  	X
	4.8 Release of Product
	 48.1
	  	Batch Certification for Shipment (QP confirmation)	  	(X)	  	X
	 4.8.2
	  	Product Release to the market	  	X	  	
	 4.8.3
	  	Certificate of Compliance and Certificate of Analysis	  	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 Validation	  	X	  	X
	 4.9.4
	  	Manufacturing Process Validation	  	(X)	  	X
	 4.9.5
	  	Shipment Validation	  	X	  	
	 4.9.6
	  	Facilities, Utilities and Equipment Validation	  	X

  

					
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	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 (API and
DP)	  	X (others)
	 4.12.2
	  	Out of Specifications (OOS) / Out of Trend (OOT)	  	(X)	  	X
	 4.12.3
	  	Confirmed OOS notification to authorities	  	X	  	
	4.13 Stability
	 4.13.1
	  	Sample Storage	  		  	X
	 4.13.2
	  	Stability Protocol, and Studies	  	X	  	(X)
	 4.13.3
	  	Stability Failures	  	X	  	(X)
	 4.13.4
	  	Stability Support Post Termination of MSA	  		  	X
	4.14 Annual Product Review / Product Quality Review
	 4.14.1
	  	General	  	X	  	(X)
	4.15 Storage and Distribution
	 4.15.1
	  	General	  	(X)	  	X
	 4.15.2
	  	Product Storage and Shipment (Ex Works)	  	(X)	  	X
	 4.15.3
	  	Product Quarantine	  	(X)	  	X

  

					
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	4.16 Product Complaints
	 4.16.1
	  	Complaint Investigation	  	X (medical, non-medical,
& quality)	  	X (quality)
	4.17 Product Recall / Field Alerts (US)
	 4.17.1
	  	Product Recall Notification and Investigation	  	X	  	X
 (Investigation)

	 4.17.2
	  	Government Agency Notification	  	X	  	
	 4.17.3
	  	Suspected Falsified Medicine/suspected re-packaging failure within parallel importation Where applicable	  	X	  	
	4.18 Reference and Retention Samples
	 4.18.1
	  	Excipient and Active Ingredient Reference Sample	  		  	X
	 4.18.2
	  	Packaging Retention Sample	  		  	X
	 4.18.3
	  	Finished Product Retention Sample	  		  	X

 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. For the purposes of this quality agreement, “business day” means a day other than a Saturday, Sunday, or a day
that is a statutory holiday in Winnipeg (Canada), Swinton (UK), [**], and the United States (USA). 

  

	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 such that either 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. 

  

					
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	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 msa’s have been fulfilled.

 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	Customer Audit Rights 

 Patheon will permit audits on reasonable prior written notice, of all
relevant premises, procedures and documentation by Cangene; to the extent such audits are related to Customer’s Product. Customer audits are limited to [**] per calendar year lasting no more than [**] days, and involving no more than [**]
auditors unless for cause. Patheon will provide access to the manufacturing facility, on reasonable prior written notice, to Customer personnel during the manufacturing of Customer product(s). 

The rights of access, audit and inspection provided herein do not include any right to access or inspect Patheon’s financial records. 

Patheon shall respond to Cangene audit report within [**] days of Cangene audit report receipt. Cangene shall provide Patheon with the audit
report within [**] days of the audit date. 
  

	4.1.3	Subcontracting 

 Patheon will not subcontract tasks to a third party without Customer’s
consent. Patheon may subcontract raw material testing to other Patheon facilities and to other qualified third party laboratories (as defined in Appendix E). 
  

	4.1.4	Self-Inspection 

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

	4.2	Regulatory Requirements 

  

	4.2.1	Permits (Site licences & GMP certificates (EU), Site Master File PIC) 

  

					
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 Patheon will obtain and maintain the
appropriate Manufacturing License(s), GMP certificates and Site Master File following the scheme defined by PIC to allow for the Manufacturing services. 
  

	4.2.2	Product Licences and Registration files life-cycle management 

 Cangene 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 may provide regulatory support in the preparation and overall regulatory consistency review of pertinent sections of new
or supplemental regulatory applications. 
 For compliance purposes, Cangene will provide Patheon with copy of sections of product
registration/regulatory submissions that are relevant to the manufacture of the Product as appropriate. 
 Prior to any submission based upon
Patheon generated data, Cangene will also provide the relevant registration sections to enable Patheon to exercise its right to review the data accuracy as per the legal terms and conditions. 

Cangene is responsible for all communications with Regulatory Authorities as well as for the approval, maintenance, and updating of marketing
approval in a timely manner. 
 In particular, in the event of a substantial change to cGMPs or regional governances directly impacting
Product Quality compliance, it shall be mutually agreed prior to its implementation. 
  

	4.2.3	Product Permits: supply of all necessary approved registration information (CTD [Common Technical Document] quality sections) and relevant updates 

Cangene 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. 
 It is the responsibility of Cangene to
provide Patheon EU sites with the accurate Product registration information as per European legislations (cGMPs guide part I—chapters 1,4,6,7 and annex 16 / directives 2001/83/EC — title IV, articles 46, 48, 51 and 2003/94/EC article 5).

  

					
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	4.2.4	Regulatory Compliance 

 Patheon will ensure that Product(s) is 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 210 and 211 and EU Directives 2003/94/EC — 2004/27/EC — 2011/62/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. 

Patheon shall notify Cangene of any quality related inspections of the Manufacturing process of the Products by Regulatory Authorities,
particularly CBER. As soon as practicable, and after the inspection by the relevant Regulatory Authorities, Patheon shall provide the results and appropriate reports received from the Regulatory Authorities to Cangene. 

 

	4.2.5	Components compliance documentation (BSE/TSE. Residual Solvents, etc) 

 Patheon will ensure that
the procured materials are in compliance with BSE/TSE, Residual Solvents, Viral safety, Residues of Metal Catalyst or Metal Reagents, risk of Melamine contamination guidelines, as per internal procedure if applicable. 

Cangene will assure the compliance to the above mentioned guidelines for the supplied materials, as per Appendix M where applicable. 

 

	4.2.6	Government Agency Inspections, Communication and Requisitions 

 Patheon will permit all relevant
inspections by regulatory authorities of premises, procedures, and documentation. 
 Patheon will notify Cangene within [**] Business Days of
receipt of any notice of inspection from a regulatory authority and within [**] of any regulatory authority request for Product samples, batch documentation, or other information related to the Product. 

Patheon will notify Cangene within [**] of receipt of any Form 483, 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. Suitable documentation in a redacted manner, if needed, will be presented. 

The responses from Patheon related to the Product will be reviewed and approved by Cangene prior to submission to the regulatory agency.
Notwithstanding, 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. 

If relevant inspections by Regulatory Authorities will be performed on Cangene’s Product, Cangene reserves the right to be in the Facility
during such inspections. Inspections requirements must be communicated in a timely manner to Cangene. 

  

					
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	4.3	Material Control 

  

	4.3.1	Test Methods and Specifications 

 Cangene will give Patheon a copy of the Specifications and
test methods used if Cangene issues raw material Specifications as well as any relevant updates. Per each raw material delivered to Patheon a MSDS document will be provided by Cangene to detail the handling procedures. 

 

	4.3.2	Material Destruction 

 Patheon has the right to either return to Cangene or dispose of any
outdated or rejected material which is of Cangene’s property. If the material is disposed of, disposal will be consistent with the nature of the material and sent to a permitted waste disposal facility. Prior to such disposal: 

 

	 	(i)	Patheon will send notice to Cangene about Patheon’s intent to dispose of the material. If no direction is received from Cangene, Patheon will dispose of the material no sooner than [**] 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 prevents unauthorized use or diversion. 

Patheon will maintain destruction records in accordance with Patheon SOP’s. A copy of the Certificate of Destruction will be sent to
Cangene. 
  

	4.3.3	Vendor Quality Management 

  

	4.3.3.1	Excipient and API Vendors: 

  

	 	(i)	If Cangene is responsible for supplying an excipient or API, Cangene will audit and approve the manufacturers and ensure cGMP and cGDP compliance in accordance with Section 4.3.4 of this Agreement. Cangene
stipulated vendor(s) will be included on Cangene’s approved vendor list (attached hereto as Appendix D). Cangene will provide to Patheon all documentation related to API identified in Appendix H. 

 

	 	(ii)	If Patheon is responsible for procuring the excipient, Patheon will audit and approve the manufacturers and ensure cGMP compliance in accordance with Patheon’s SOP. The Patheon stipulated vendor(s) will be included
on Patheon’s approved vendor list (attached hereto as Appendix C). 

  

	4.3.3.2	Primary Packaging Component Vendors: 

  

	 	(i)	If Cangene is responsible for the supply of a packaging component vendor, Cangene will audit and approve the manufacturer and ensure cGMP compliance. Cangene stipulated vendor(s) will be included on the approved vendor
list (attached hereto as Appendix D). 

  

					
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	 	(ii)	If Patheon is responsible for procuring the packaging component vendor, Patheon will audit and approve the manufacturer 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	Customer Supplied Materials Incoming Material Testing 

 Cangene is responsible for vendor
qualification of Customer furnished materials and for providing a certificate of compliance confirming the following where applicable: 
  

	 	a.	That the materials are compliant with the provisions outlined in the “Note for Guidance on minimizing the risk of transmitting spongiform encephalopathy agents via human and veterinary medicinal products”
(EMEA/410/01, rev.3 since 03.2011 or update) and 

  

	 	b.	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 III to be present and the material, if
tested, will comply with established EP / USP / ICH requirements. If any of the solvents listed in the EP / USP / ICH residual solvents Class I, Class II or Class III are used in the manufacture or are generated in the manufacturing process,
solvents of concern will be indicated. 

  

	 	c.	Information on genotoxic Impurities, Residues of Metal Catalyst information. 

  

	 	d.	An API GMP compliance declaration to the EU directive 2004/27/EC (when sourced from an EU country) or to ICH Q7 (when sourced from a non EU country) and 

 

	 	e.	certificate of compliance confirming that such Materials are compliant with the provisions outlined in the US FDA Guideline “Pharmaceutical Components at risk for Melamine contamination”

 Cangene is responsible for providing Patheon with documents on supplied API, as defined in Appendix H. 

API lots will be delivered by Customer to Patheon in their fully approved status with all required Certifications i.e. Cangene Certificate of
Analysis and API Manufacturer’s Certificate of Compliance. 

  

					
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	4.3.5	Patheon Supplied Materials Incoming Material Testing 

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

	4.3.5.1	That the materials are Animal Component Free 

  

	4.3.5.2	That the materials are compliant with the provisions outlined in the “Note for Guidance on minimizing the risk of transmitting spongiform encephalopathy agents via human and veterinary medicinal products”
(EMEA/410/01, rev. 3 since 03.2011 or update) 

  

	4.3.6	In-Coming Material Release 

 Prior to its use in the manufacture of any Product, all material(s)
supplied by Cangene, through its designee Cangene, will be inspected, tested, and approved by Patheon against the Specification approved by Cangene. 

Cangene will provide to Patheon the API drug substance in [**] packed in a box with [**] for shipping. Patheon shall verify the presence of the
temperature monitors, download the data and verify compliance with shipping conditions. Patheon will send evidence of temperature monitoring to Cangene. 

The Certificate of Analysis (including among the others ID, bioburden, endotoxin and expiry date), a statement of release (Certificate of
Compliance) and a separate shipping sheet will be used to confirm the package contents upon its arrival at Patheon. 
 Cangene shall provide
a sample of the API for identity testing with each shipment and a retain sample for each supplier lot of API. The sample of the API shall be filled at the same time as the API intended for the manufacturing purposes. Representativeness of samples
with respect to parent API bulk lot is based on Cangene’s evaluation of manufacturing process and samples collection procedure at the API manufacturing site. 

Patheon will perform only an identification test according to the approved Specification. 

 

	4.3.7	Storage and Transportation of Material 

 Patheon shall ensure that storage and transport
conditions of raw materials used to manufacture the Products are appropriately controlled to ensure that Products meet the agreed Specification throughout the specified storage life and comply with the CGDP (Distribution) requirements. 

 

	4.4	Building, Facilities, Utilities and Equipment 

  

	4.4.1	General 

  

					
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 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’s SOP’s. 
  

	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. Qualification, calibration and maintenance records will be kept according to
Patheon SOP’s for all critical equipment. Patheon will calibrate instrumentation and qualify computer systems used in the manufacture and testing of the Product in accordance with Patheon’s SOP’s. 

 

	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 SOP’s. In any event, Cangene shall be
notified if an unresolved adverse EM trend has been identified in advance of its next scheduled fill. Cangene shall have the right to determine whether or not to proceed with the fill. 

 

	4.5	Production Controls 

  

	4.5.1	Test Methods and Specifications 

 Cangene will provide to Patheon the finished In Process
Control (IPC) and release Product Specifications and will develop and supply validated analytical test methods to Patheon for the finished Product at release (and shelf-life testing if requested). Patheon is responsible to verify the performance of
test methods in the actual condition of use. 
  

	4.5.2	Master Batch Record 

 Cangene will provide the Specifications to Patheon and Patheon will
manufacture Product in accordance with the Specifications. 
 Patheon is responsible for preparing the master batch records for the Product,
however, Cangene is responsible to review and approve such master batch records prior to 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 Cangene’s quality unit. Any changes made to issued batch records (prior to master
revisions) must be reviewed and approved by Cangene’s quality unit prior to implementation unless otherwise agreed to in writing. 

  

					
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	4.5.3	Reprocessing and Rework 

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

	4.5.4	Personnel and Training 

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

 

	4.5.5	Container Closure Integrity Test 

 Patheon will perform a 100% non-destructive Container Closure
Integrity Test, on each batch of final product, as required by (among the others) EU GMP Annex 1. 
  

	4.6	Packaging, Labeling and Printed Materials — Section Not Applicable Cangene responsibility 

  

	4.6.1	Master Batch Packaging Records 

 VOID 

 

	4.6.2	Printed Material and Artwork 

 VOID 

 

	4.6.3	Test Methods and Method Validation 

 VOID 

 

	4.7	Exception Reports (Deviations / Investigations) 

  

	4.7.1	Manufacturing/Packaging Instruction Deviations 

 Patheon will document, investigate and resolve
deviations from approved manufacturing/packaging instructions or Specifications in accordance with Patheon’s SOP’s. Patheon will report and obtain approval from Cangene’s responsible person for deviation report (“DR”) type
deviations where there is a potential to affect Product quality. Cangene approval will not be unreasonably withheld. Patheon will provide copies of all DR’s to Cangene as part of the executed batch record, within [**] calendar days. 

  

					
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	4.7.2	Notification of Deviations 

 Patheon will notify Cangene within [**] of discovery if any
significant deviation occurs during manufacture of the Product, where such deviation has the potential to affect the quality, efficacy or availability of the Product. 

If the deviation affects, or could affect, batches already released and distributed, Patheon will notify Cangene within [**] after detecting
the deviation. 
 Cangene will provide feedback to Patheon on the investigation report within [**] Calendar days. 

 

	4.8	Release of Product 

  

	4.8.1	Batch Certification for Shipment (QP Confirmation) 

 Batch review, release and certification for
shipment to Cangene will be the responsibility of Patheon’s Quality Assurance department and Qualified Person, who will act in accordance with Patheon’s SOP. 
  

	4.8.2	Product Release to the Market 

 The final responsibility of product release to market after
secondary packaging is assigned to Cangene, based on preliminary batch certification on bulk batch done by Patheon. 
  

	4.8.3	Certificate of Compliance and Certificate of Analysis 

 For each batch certified by Patheon,
prior to release for shipment to Cangene, Patheon will deliver to Cangene a Certificate of Analysis, CoA (signed by QC Manager) which contains a statement of compliance of batch to Specifications and Certificate of Compliance, CoC (signed by
Qualified Person) which will include a statement that the batch has been manufactured in accordance with cGMPs and complies with the Specifications. Both documents will be provided under official Patheon letterhead (containing address) and their
format will comply with the templates reported in Appendix F and Appendix G in accordance with approved specifications. 
 Clinical Trial
Material (CTM) batches already manufactured in Patheon [**] facility and following Clinical Trials Manufacturing Agreement may be requested by Cangene to be re-designated to commercial destination. In such instances, the batches will be re-examined
in the light of requirements of this Quality Agreement, Product Registration and Specification; if such compliance is demonstrated the batches will be re-certified and new CoAs and CoCs will be issued by Patheon. This circumstance shall apply to
either batches already released according to CTM requirements and batches still pending release, irrespective if still present in Patheon warehouse or already delivered to Client. Additional reference samples may be collected if necessary. 

  

					
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	4.9	Validation 

  

	4.9.1	Master Validation Plan 

 Patheon will establish applicable master validation plans and maintain
a validation program for the Product. Cangene 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 

 Cangene will provide to Patheon, toxicological information to be
used in the development of a cleaning program. Patheon will maintain an appropriate cleaning and cleaning validation program, and shall provide information to Cangene as necessary to support regulatory filings. 

 

	4.9.3	Analytical Method Validation 

 Cangene must ensure that its analytical methods (including
packaging procedures) are validated. If the methods are not validated by Cangene, then Patheon may assist in validation development with the costs being borne by Cangene. 
  

	4.9.4	Manufacturing Process Validation 

 Patheon will establish, together with Cangene, a process
validation strategy for the Product. Cangene will review and approve the process validation protocol and process validation report for the Product. 
  

	4.9.5	Shipment Validation 

 Cangene shall establish a qualified shipping method, including controls
for temperature and humidity, if necessary. Placement locations for temperature monitors will be provided by Cangene to Patheon. 
  

	4.9.6	Facilities, Utilities and Equipment Validation 

 Patheon is responsible for the qualification
and/or validation of its facility, equipment, and utilities. 
  

	4.10	CHANGE CONTROL 

  

	4.10.1	General 

  

					
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 Patheon will notify and obtain
approval from Cangene before implementing any proposed changes to the process, materials, testing, equipment or premises, where such changes may affect the Product. 

Cangene’s approval will not to be unreasonably withheld. Cangene approval is expected to be completed in [**] Business days from the
receipt of the Patheon notification. 
 Patheon shall refrain from any activity which could adversely affect the quality of the products.
Patheon shall inform Cangene prior to the implementation of any product categories according to the categories listed below which are introduced to the same compounding or clean rooms where the Product is manufactured: 

[**] 
 Such product introduction
would need to be assessed using change control at Patheon, and requires Cangene approval prior to implementation. 
 Cangene will be
responsible for determining whether or not to initiate registration variation (EU)/post-approval change (US) procedures and for maintaining adequate control over the quality commitments of the marketing authorization made to the regulatory
authorities by Cangene for the Product. 
 Patheon will evaluate any change proposal initiated by Cangene with opening an internal change
control and delivering it to Cangene for notification purposes. Documents whose revision is impacted by change will be presented to Cangene for approval 

Following validation of a process change, Patheon will deliver a copy of the related validation report to Cangene and the associated stability
data, if applicable, as it becomes available. 
 In the event of a substantial change to cGMPs or regional governances directly impacting
Product Quality compliance, it shall be shared between both parties prior to its implementation. 
  

	4.11	Documentation 

  

	4.11.1	Record Retention 

 Patheon will maintain all batch records for a minimum of [**] past Product
expiry date of the batches to which it related or at least [**] years after the certification whichever is longer period (EU specificity) and supply all these records to Cangene upon request. 

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

  

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

	4.11.2	Batch Document Requisition 

 At the request of Cangene, Patheon will provide a copy of any of
the executed batch documents relating to Cangene Product within [**] Business Days of such request. 
 Patheon will share with Customer a
defined Batch numbering rule which will be adopted to identify each product batch. 
  

	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 SOP’s. 
 Upon receipt,
the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Cangene. 
 Cangene will provide to
Patheon the Active Material Specifications. 
 Cangene will provide to Patheon test methods for Active Material and excipient’s (if
non-compendial). Cangene is responsible for validating non-compendial testing methods. If these methods are not validated by Cangene, then Patheon may assist in validation development with the costs being borne by Cangene. 

 

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

 Patheon will notify Cangene’s quality
unit of confirmed Out-of-Specification (“OOS”) or Out-of-Trend (“OOT”), (if latter condition is applicable), results within [**]. Confirmed OOS is treated as a Deviation at Patheon after Phase 1 investigation is complete. Patheon
will generate a DR as per Patheon’s SOP and obtain approval of the DR from Cangene’s responsible person within their quality unit. Cangene’s approval will not be unreasonably withheld. 

 

	4.12.3	Confirmed OOS Notifications to Authorities 

 Cangene will notify authorities of confirmed
out-of-specification (“OOS”) and communicate to Patheon any communication to Regulatory authorities within [**] Business days. 
  

	4.13	Stability 

  

					
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	4.13.1	Sample Storage 

 Patheon will store stability samples as required. 

 

	4.13.2	Stability Protocol and Studies 

 Cangene will develop and validate stability indicating assay(s)
prior to process validation. If required, Patheon may assist with the cost being borne by Cangene. 
 If requested, Patheon will conduct
stability studies in accordance with the agreed and validated stability testing analytical methods and specifications at the agreed upon testing points in accordance with the approved stability protocol. 

If requested, Patheon will perform the stability testing described in a stability protocol agreed to by both Patheon and Cangene. Stability
data will be provided by Patheon to Cangene on an ongoing basis as agreed to by both parties. 
  

	4.13.3	Stability Failures 

 Cangene will notify Patheon of any Stability Failure occurred on batches
manufactured by Patheon for proper evaluation to determine existing impact deriving from Patheon activities. 
 Patheon will notify Cangene
of any stability failure for Product supplied to Cangene where employed to conduct such testing. If a result indicates that a Product has failed to remain within Stability Specifications, Patheon will notify Cangene within [**]. 

For OOS discovered during stability refer to 4.12.3 paragraph. 
  

	4.13.4	Stability Support Post Termination of MSA 

 If the MSA is terminated, Patheon will continue to
provide Cangene with stability data supporting the acceptability of the Product until all Product distributed by Cangene has reached the end of its shelf-life, for Product manufactured at Patheon, as applicable. 

 

	4.14	Annual Product Review / Product Quality Review 

  

	4.14.1	General 

 Patheon will complete the annual / product quality review (PQR) product review (APR)
in accordance with regulatory requirements of the Product marketed authorization. Patheon will provide copies of all information and correspondence necessary to support the APR when requested by Cangene. A complete copy of the final document will be
sent to Cangene. 

  

					
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 If the PQR is prepared, it will be
finalised by Patheon and provided to Cangene, for revision and approval, by the end of the third quarter of the calendar year. 
 Annually,
Patheon shall perform and document an APR with respect to consistency of the process. This review shall include, as a minimum, the number and disposition of Batches Manufactured, changes to the Product and processes, customer complaints, recalls and
returns, and a summary of relevant Manufacturing Deviations and rejects. The report will be conducted in accordance with relevant cGMP reference US 21CFR Part 211.180 and Eudralex Vol 4 Chapter 1 and according to Patheon’s SOP and shall be sent
to Cangene. This document will support the “Customer Annual Product Review” and “Product Quality Review”. The report will also include a summary of visual examination of QC retain samples of product batches if destined to US as
requested by US 21CFR Part 211.170 for evidence of deterioration. The report will be provided to Cangene within [**] calendar days of the reporting period. 
  

	4.15	Storage and Distribution 

  

	4.15.1	General 

 Patheon will ship Product Ex-Works in accordance with the provided Specifications and
agreed qualified transportation requirements provided by Cangene to Patheon, 
 Cangene is responsible for the transport according to local
governances (such as EU cGDP and directive 2011/62/EC). 
  

	4.15.2	Product Storage and Shipment (Ex Works) 

 Patheon will communicate any proposed changes in
storage or shipping to Cangene for review and approval. Cangene 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. Quarantine shipment will be considered as an exceptional practice and will require formal mutual agreement between the parties. 
  

	4.16	Product Complaints 

  

	4.16.1	Complaint Investigation 

 Cangene will investigate and resolve all medical and non-medical
Product complaints. 
 Patheon will acknowledge receipt of the complaint and will investigate all Product quality complaints related to the
Manufacturing Services provided. 

  

					
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 Cangene will endeavour to retrieve
complaint sample(s) and forward them to Patheon within [**] calendar days whenever possible to facilitate a complete and comprehensive investigation. In the event that the complaint sample cannot be retrieved from the field and forwarded to Patheon
within [**] calendar days, Cangene will communicate such to Patheon. If the investigation cannot be completed within [**] calendar days, Patheon will process the complaint investigation per procedure, and provide a copy of the report to Cangene.
Should the complaint sample be provided after the initial report has been completed, Patheon will open a second investigation with clear cross reference to the associated investigation (where/if applicable). 

Cangene is responsible for responding to the complainant. 
  

	4.17	Product Recall/Fields Alerts (US) 

  

	4.17.1	Product Recall Notification/Investigation 

 Cangene will make reasonable efforts to notify
Patheon about any Product recall or other regulatory type product notification (e.g. US field alert) as soon as possible and prior to informing the appropriate regulatory authorities. Cangene will be responsible for all related recall activities.

 If Patheon discovers, after release and distribution of a batch(es), any finding which impacts, or could impact, on the quality and safety
attributes of the batch(es), Patheon will notify Cangene as soon as possible. Patheon will provide its best effort for the recall of the affected batch(es). 

Patheon shall proceed with a comprehensive investigation in a timely manner and feedback to Cangene to enable regulatory actions. 

 

	4.17.2	Government Agency Notification 

 Cangene will perform the Product recall and will inform the
appropriate regulatory authorities. Where legislated, Patheon reserves the right to notify regulatory authorities of Product quality issues. Patheon will inform Cangene prior to any notification to the regulatory authorities. 

 

	4.17.3	Suspected Falsified Medicine/suspected re-packaging failure within parallel importation 

 If
applicable Cangene shall notify immediately Patheon of any suspected falsified Product to enable the investigation in a timely fashion. In the event of the confirmed falsified Product, all appropriate measures to physically and securely segregate it
from the legitimate Products supply chain shall be taken and Cangene shall inform the competent authorities. 

  

					
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 In the same way, if brought to the
attention of Cangene, Cangene shall notify immediately Patheon of any suspected repacking failure which has occurred within a parallel importation procedure. 
  

	4.18	Reference and Retention Samples 

  

	4.18.1	Excipient and Active Ingredient Reference Sample 

 Patheon will keep a reference sample of each
material supplied to Patheon and used to manufacture the Product (including but not limited to active pharmaceutical ingredients, excipients and packaging materials with the exception of water and compressed gases). The reference sample size will be
in agreement with relevant cGMPs, i.e. 21 CFR211.170 and Eudralex Vol.4 Annex 19 or local regulations. The reference sample will consist of at least [**] 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 [**] beyond the expiration date of the last batch of the product containing the materials. The reference samples will be made available by Patheon to Cangene, if requested. 

 

	4.18.2	Packaging Retention Sample 

 Patheon shall retain the relevant Retain Samples of packaging
materials, related to the manufacture, at least [**] after the last batch manufactured with the material has expired. 
  

	4.18.3	Finished Product Retention Sample 

 Retention samples of finished Product will be retained by
Patheon for [**] past Product expiry or such longer period as required by law limited to [**] the quantity necessary for Patheon internal testing. 

Where applicable, the legal sample(s) of finished Product must be retained by Cangene. 

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: 
 Contract Giver: 
  

									
	CNJ Holdings, Inc.	 		 		 	
					
	By:	 	 /s/ Jeff Broadfoot
	 		 		 	Date: July 13, 2015
		 	Jeff Broadfoot, Senior Director, Quality Assurance	 		 		 	

 Cangene Corporation, Inc. 

  

					
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	By:	 	 /s/ Jeff Broadfoot
	 		 		 	                                Date: July 13, 2015
		 	Jeff Broadfoot, Senior Director, Quality Assurance	 		 		 	

 CONTRACT ACCEPTOR 

Patheon [**] 
  

									
	By:	 	 /s/ Alessia D’Ettole
	 		 		 	                                Date: 25/06/2015
		 	Alessia D’Ettole, Quality Assurance Manager	 		 		 	
					
	By:	 	 /s/ Tiziana Archilletti
	 		 		 	                                Date: 25/06/15
		 	Tiziana Archilletti, QA/QC Director	 		 		 	
					
	By:	 	 /s/ Alessandro Barbato
	 		 		 	                                Date: 25-06-2015
		 	Alessandro Barbato, [**] QP	 		 		 	

  

					
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 SECTION 5: APPENDICES 

 

	 	•	 	Appendix A: Product(s) & Markets 

  

	 	•	 	Appendix B: Key Contacts 

  

	 	•	 	Appendix C: Patheon Approved Vendor List 

  

	 	•	 	Appendix D: Customer Approved Vendor List 

  

	 	•	 	Appendix E: Patheon Approved Contract Laboratories List 

  

	 	•	 	Appendix F: Patheon Certificate of Analysis template 

  

	 	•	 	Appendix G: Patheon Certificate of Compliance template 

  

	 	•	 	Appendix H: API Materials EU Requirements 

  

					
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 APPENDIX A: PRODUCT(S) 

 

							
	 Products (s)
	  	Galenic
Form	  	Dosage (Strength)	  	API name
	IXINITYIM	  	[**]	  	[**]	  	[**]
		  		  	[**]	  	

  

					
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 APPENDIX B: KEY CONTACTS 

 

					
	 	  	 Patheon
	  	Cangene
	 Responsibility
	  	 Quality Assurance
	  	General
	Name	  	[**]	  	[**]
	Title	  	[**]	  	[**]
		  		  	[**]
	Phone	  	[**]	  	[**]
	Mobile	  		  	[**]
	Fax	  		  	[**]
	E-mail	  	[**]	  	[**]
	Address	  	[**]	  	155 Innovation Drive
		  	[**]	  	Winnipeg, Manitoba
		  	[**]	  	Canada
		  		  	R3T 5Y3
			
	 Responsibility
	  	 Regulatory Affairs
	  	Regulatory Affairs
	Name	  	[**]	  	[**]
	Title	  	[**]	  	[**]
		  		  	[**]
	Phone	  	[**]	  	[**]
	Mobile	  		  	
	Fax	  		  	
	E-mail	  	[**]	  	[**]
	Address	  	[**]	  	155 Innovation Drive
		  	[**]	  	Winnipeg, Manitoba
		  	[**]	  	Canada
		  		  	R3T 5Y3
			
	 Responsibility
	  	 Product Complaints/Deviations /

Documentation
	  	Audits/Product
Complaints
	Name	  	[**]	  	[**]
	Title	  	[**]	  	[**]
		  		  	[**]
	Phone	  	[**]	  	[**]
	Mobile	  	[**]	  	[**]
	Fax	  		  	[**]
	E-mail	  	[**]	  	[**]
	Address	  	[**]	  	155 Innovation Drive
		  	[**]	  	Winnipeg, Manitoba
		  	[**]	  	Canada
		  		  	R3T 5Y3

  

					
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	 Responsibility
	  	 Product Release
	  	Product Release,
Deviations, OOS/OOT,
Documentation,
Inspection Notification
	Name	  	[**]	  	[**]
	Title	  	[**]	  	[**]
		  		  	[**]
	Phone	  	[**]	  	[**]
	Mobile	  		  	
	Fax	  	[**]	  	
	E-mail	  	[**]	  	[**]
	Address	  	[**]	  	155 Innovation Drive
		  	[**]	  	Winnipeg, Manitoba
		  	[**]	  	Canada
		  		  	R3T 5Y3
			
	 Responsibility
	  	 Business/Account Manager
	  	Project Manager
	Name	  	[**]	  	[**]
	Title	  	[**]	  	[**]
	Phone	  	[**]	  	[**]
	Mobile	  		  	[**]
	Fax	  		  	
	E-mail	  	[**]	  	[**]
	Address	  	[**]	  	155 Innovation Drive
		  	[**]	  	Winnipeg, Manitoba
		  	[**]	  	Canada
		  		  	R3T 5Y3

  

					
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 APPENDIX C: PATHEON APPROVED VENDOR
LIST 
  

			
	 ITEM
	  	 SUPPLIER

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

  

					
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 APPENDIX D: CUSTOMER APPROVED
VENDOR LIST 
  

			
	 ITEM
	  	 SUPPLIER

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

  

					
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 APPENDIX E: PATHEON APPROVED
CONTRACT LABORATORIES LIST 
 [**] 

  

					
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		 	APPENDIX F: PATHEON CERTIFICATE OF ANALYSIS TEMPLATE
		
		 	CERTIFICATE OF ANALYSIS
		
		 	Name: IXINITY XXX IU
		 	Specification #: SP- 35XXXX/36XXXX
		 	Version: NN
		 	Category: [**]
		
		 	Code: 36XXXX
		 	 Lot #: xxxxxxxxx
 Quantity: xxxx vials

Date of Manufacture: dd/mm/yyyy

		 	 Recommended storage conditions: 2-8°C
  

Results

  

													
	 Test Description
	  	Method #	 	  	Acceptance Criteria	 	  	Results	 
	 <description of the test>
	  	 	<method number>	  	  	 	<acceptance criteria>	  	  	 	<actual results>	  
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			
		  				  				  			

 Note: 
 Status

  
 The material identified above has been
analyzed and found to be compliant with all approved release requirements. 
  

					
	 Approver: Name, Surname
	  	Quality Control Manager	  	Date:
	 Signature:
	  	  

  

					
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 APPENDIX G: PATHEON CERTIFICATE OF
COMPLIANCE TEMPLATE 
 INTERIM BATCH CERTIFICATE 

IXINITYTM xxxxlU 
  

			
	Batch N.:xxxxxxxx	  	Code: 360xxx
		
	Manufacturing date: dd/mm/yyyy	  	Quantity: xxxxx

 I hereby certify that the above mentioned Batch has been manufactured in the Sterile [**] Department of the Pharmaceutical
plant of Patheon [**] site, in full compliance with the cGMP requirements (Eudralex Volume 4 and applicable Annexes including but not limited to Ann.1 and Ann.16; US21CFR Parts 210, 211) and applicable Directives (2001/83/EC; 2003/94/EC) of
Regulatory Authority as specified in the Quality Agreement. The plant has been approved by the [**]. 
 The batch also complies with Guideline
EMEA/410/01 “Note for guidance on minimising the risk of transmitting animal spongiform encephalopathies” 
 The documentation of batch
manufacturing and process control has been reviewed and found to be in compliance with the above mentioned cGMPs, Product Specifications and Marketing Authorization File issued by the Relavant Regulatory Authorities. 

The DS lot number(s) associated to batch manufacture is/are: 

Patheon lot number: xxxxx 
 CMC Biologics lot number:
xxxxx 
 The Bowie Dick test has been carried out one time per day prior to use the autoclave porous load sterilization. 

[There have been no deviations impacting product release.] 

[Details of deviations (Reference No.......) have been provided and all deviations have been closed.] 

 

			
	Date:	  	 Dr. Alessandro Barbato
 [**] Qualified
Person

  

					
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 APPENDIX H: API STARTING MATERIALS
EU REQUIREMENTS (2 PAGES) 
 Cangene is responsible for providing Patheon with the following on any supplied API: 

Registration information 
  

	 	•	 	all registered DS manufacturing sites including addresses & functions; 

  

	 	•	 	approved registered file (CTD module 3.2.S) and any relevant update; 

  

	 	•	 	latest Certificate of suitability to the European Pharmacopoeia (CEP), Active Substance Master File (ASMF) or scientific data in force (as applicable). 

Regulatory compliance information 
  

	 	•	 	for DS sourced from US 

  

	 	•	 	EU Member State or foreign authority GMP certificate or GMP manufacturer declaration ; 

  

	 	•	 	TSE/ BSE (or viral safety where applicable), Residual Solvents, Genotoxic Impurities, Residues of Metal Catalyst and Reagent information as applicable. 

Quality compliance information 
  

	 	•	 	Proof of the DS manufacturer GMP/GDP compliance via audit reports or summary; 

  

	 	•	 	Well identified and documented DS supply chain (including API manufacturers, brokers, traders, re-packers, re-labellers, micronisers and importers). 

Current EU regulation references 
  

	 	•	 	Compilation of the Community Procedures on Inspections and Exchanges of Information (version in force); 

  

	 	•	 	Union format for registration of Manufacturer, Importer or Distributor of Active Substance; 

  

	 	•	 	Union format for a GMP certificate [including active substances]; 

  

	 	•	 	Union format for a GDP certificate for active substances to be used as starting materials. 

  

	 	•	 	GMP Guide Part I: Basic Requirements for Medicinal Products (version in force): 

  

	 	•	 	Chapter 5: Production ; 

  

	 	•	 	Chapter 7: Outsourced activities, 

  

	 	•	 	GMP Guide Part II: Basic Requirements for Active Substances used as Starting Material (version in force). 

 

	 	•	 	GMP Guide Q&As - Part II: questions 8,9,10 (version in force). 

  

	 	•	 	GDP for active substances: [SANCO/D/6/SF/mg/ddg1.d.6(2013)179367] draft (FEB/2013). 

  

					
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	 	•	 	Directive 2011/62/EU (JUL/2011) articles 46, 46 b (2), 47, 111b and derivative texts: 

  

	 	•	 	Implementing decision on the assessment of a third country’s regulatory framework applicable to active substances of medicinal products for human use [2013/51/EU] (JAN/2013), 

 

	 	•	 	Template for written confirmation [SANCO/SFS/SF/mg/ddg1 .d 6(2013)118630] (version in force) & Q&As [SANCO/D/6/] (version in force)]

  

	 	•	 	Implementing regulation on principles and guideline for GMP for AS [(EU) n°1252/2014] (MAY/2014) 

  

	 	•	 	EM A/334808/2014: Qualified Person’s declaration concerning GMP compliance of the active substance manufacture—“The QP declaration template” and guidance for the “QP declaration template
EMA/196292/2014 (version in force). 

  

	 	•	 	EMA/410/01: Note for guidance on guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal product (version in force). 

 

	 	•	 	Ph. Eur. 5.2.8: Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. 

 

	 	•	 	EU EMA/CHMP/ICH/82260/2006: (ICH topic Q3C R5) Impurities - guideline for residual solvents (version in force) + annexes I & II CPMP/QWP/450/03 (version in force) 

 

	 	•	 	Ph. Eur. Chapter 5.4: Residual Solvents, 

  

	 	•	 	EMEA/CHMP/SWP/4446/2000: Guideline on the specification limits for residues of metal catalysts or metal reagents (version in force). 

 

	 	•	 	Ph Eur Chapter 5.20: Metal catalyst and metal reagents residues. 

  

	 	•	 	ICHQ3D Draft guideline for elemental impurities (step 4) (DEC/2014). 

  

	 	•	 	CPMP/SWP/5199/02 - EMEA/CHMP/QWP/251344/2006: Guideline on the limits of genotoxic impurities (version in force) + Q&As EMA/CHMP/SWP/431994/2007 (version in force). 

  

					
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