Document:

EX-10.4

 Exhibit 10.4 

AMENDMENT 
 TO THE

 SUPPLY AGREEMENT 

BETWEEN 
 APTALIS PHARMA
CANADA, INC. (formerly Axcan Pharma, Inc.) 
 AND 

PADDOCK LABORATORIES, LLC (assignee from Paddock Laboratories, Inc.) 

This Amendment (“Amendment”) to the Supply Agreement dated May 7, 2004, as amended (the “Agreement”) is
by and between Aptalis Pharma Canada, Inc. (formerly Axcan Pharma, Inc.), a company organized under the laws of Canada and having a place of business at 597, Boul. Laurier, Mont-Saint-Hilaire, QC J3H 6C4, Canada (“Aptalis”), and
Paddock Laboratories, LLC (assignee to the Agreement from Paddock Laboratories, Inc.), a company organized under the laws of Delaware and having a principal place of business at 3940 Quebec Avenue North Minneapolis, MN 55427 (“Paddock”).
Capitalized terms not defined herein shall have the meanings given to them in the Agreement. 
 WITNESSETH: 

WHEREAS, Paddock and Aptalis are parties to the Agreement; and 

WHEREAS, Paddock and Aptalis wish to extend the Term of the Agreement and amend the Agreement as described herein. 

NOW, THEREFORE, in consideration of the covenants contained herein the parties hereto, intending to be legally bound hereby, agree to amend
the Agreement as follows: 
 In accordance with Section 11.1 of the Agreement, the parties hereby mutually agree to (a) extend the
Term of the Agreement through November 4, 2016; and (b) automatically extend the Term of the Agreement for an additional two years through November 4, 2018 (the “Automatic Two-Year Renewal”) absent written notice from one
party to the other on or before May 4, 2016 cancelling the Automatic Two-Year Renewal. 
 In addition, the following amendments are
being made to the Agreement: 
 In all instances where “Axcan Pharma” is used in the Agreement it should be replaced with
“Aptalis”. 
 Section 1.1.13 shall be replaced with: 

1.1.13 “Product” means a one (1) gram Mesalamine Suppository, in finished and packaged form as either the Canasa brand
or authorized generic, as more specifically identified on Exhibit A; 
 Section 2.2, first sentence shall be replaced with: 

During the Term of this Agreement, Aptalis or its designees (including its designated third party authorized generic distributors
(“AGDs”)), shall purchase from Paddock a minimum of [*] of its annual requirements of Product and Paddock shall manufacture for and supply Product to Aptalis and its designees in accordance with applicable Laws, the Specifications, cGMP
and the terms and conditions of this Agreement, in such packaged form (Canasa brand or authorized generic), quantities, on such dates and to such locations as Aptalis or its designees shall direct, as provided herein. 

  

	[*]	Confidential treatment requested. 

 Section 2.9.2, fourth sentence, shall be replaced with 

All Active Ingredient delivered to Paddock shall be either (a) accompanied by the relevant release certificate, or (b) tested and
released by Paddock; as chosen by Aptalis at its sole discretion. 
 Section 3.1 shall be replaced in its entirety by the following
paragraph: 
 3.1 Price. The Price to be paid to Paddock by Apatalis for the supply of Product shall be as set forth in
Exhibit D and shall be effective as of the Effective Date of this Amendment. The Price shall be increased annually (effective on the anniversary of the Effective Date of this Amendment) by [*] for the most recent prior twelve (12) month period.

 Section 6.6 shall be replaced in its entirety by the following paragraph: 

6.6 Non-Competition. Paddock hereby agrees and undertakes, for [*] following expiration or termination of this Agreement for any
reason whatsoever other than a non-payment default under this Agreement by Aptalis, not to manufacture, supply or distribute, directly or indirectly, for itself or on behalf of any Person, any suppository product containing mesalamine, for the
United States and/or Canadian markets, except for mesalamine rectal suspension products commercialized by Paddock in the United States under ANDA number A076751. 

In Section 13.1 please change the notice section for Paddock to be: 

PADDOCK LABORATORIES, LLC. 
 c/o
Perrigo Company 
 515 Eastern Avenue 

Allegan, MI 49010 
 Attention:
General Counsel 
 Fax Number: (269) 673-1386 

In Exhibit A, the first sentence is hereby deleted in its entirety and replaced with the following sentence: 

One (1) gram mesalamine, USP, rectal suppositories, packaged in appropriate (Canasa brand or authorized generic) boxes with insert. 

  

	[*]	Confidential treatment requested. 

 Exhibit D is hereby deleted in its entirety and replaced with the following new
Exhibit D: 
 EXHIBIT D 

PRICES 
 Pricing
for Product is as follows: 
  

					
	 Product
	  	Price Per Unit	 
	 3 count Product
	  	$	 [*]	  
	 30 count Product
	  	$	 [*]	  
	 42 count Product
	  	$	 [*]	  
	 1080 count Product
	  	$	 [*]	  

 Pricing does not include the cost of the Active Ingredient which will be purchased by Aptalis and drop shipped
to the Facility or, if directed by Aptalis in accordance with subsection (ii) of paragraph 2.9.2, purchased by Paddock and invoiced to Aptalis either as a separate line item or by separate invoice, as may be reasonably agreed to by the parties.
Pricing does include all finished Product testing to be performed by Paddock, if Aptalis elects to have Paddock perform such testing as described in paragraph 2.9.2. 

This Amendment, together with the Agreement, constitute the entire agreement between the parties with respect to the subject matter contained
therein, and together, supersede and replace any and all prior and contemporaneous understandings, arrangements and agreements, whether oral or written, with respect to the subject matter. 

Except as otherwise amended hereby, the Agreement shall remain in full force and effect as presently written, and the rights, duties,
liabilities and obligations of the parties thereto, as presently constituted, will continue in full effect. 
 IN WITNESS WHEREOF, the Parties hereto
have caused this instrument to be executed by their duly authorized officers with effect as of the 29th day of August, 2013 (the “Effective Date”). 
  

									
	APTALIS PHARMA CANADA, INC.	 		 	PADDOCK LABORATORIES, LLC
					
	Signed:	 	 /s/ Dan Salain
	 		 	Signed:	 	 /s/ Douglas S. Boothe

					
	Name:	 	 Dan Salain
	 		 	Name:	 	 Douglas S. Boothe

					
	Title:	 	 Vice President of Global Supply Chain and Manufacturing
	 		 	Title:	 	 EVP, Pharmaceuticals

  

	[*]	Confidential treatment requested.EX-10.5

 Exhibit 10.5 

Supply Agreement 

between 
 INFAR 

and 
 AXCAN PHARMA INC.

 THIS SUPPLY AGREEMENT (the “Agreement”) dated the 16th day of September 2008. 
 B E T W E E N: 

INFAR 
 a corporation existing
under the laws of Spain, 
 Ctra. N-II, Km. 680.6 

08389 Palafolls 
 Barcelona,
Spain 
 (hereinafter referred to as “INFAR”), 

- and - 
 AXCAN PHARMA INC. 

a corporation existing under the laws of Canada, 

597, Laurier Boulevard 

Mont-Saint-Hilaire, Quebec J3H 6C4 

Canada 
 (hereinafter referred
to as “AXCAN”). 
 PREAMBLE 

WHEREAS AXCAN is a leading specialty pharmaceutical company that develops, manufactures, markets and distributes a broad line of gastrointestinal (GI)
finished products primarily in North America and Europe; 
 WHEREAS INFAR is a supplier of mesalamine USP/EP and its mission is to provide highest quality
ingredients made under cGMP at competitive prices; 
 Whereas AXCAN is involved in the commercialization of rectal suppositories and tablets containing
mesalamine and has a demand for the drug substance; 
 Whereas INFAR wishes to supply mesalamine on an exclusive basis to AXCAN in and for the Territory,
for use in and for sales of suppositories, tablets and other products sold by Axcan in and for the Territory, under the terms and conditions as described herein; 

  

	[*]	Confidential treatment requested. 

  
 Page 2 of 20 

 EXECUTION COPY 
  

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

ARTICLE 1 - INTERPRETATION 
  

	1.1	Definitions  

 The following terms shall, unless the context otherwise requires,
have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings: 
 “Active
Pharmaceutical Ingredient” or “API” is mesalamine USP (and/or EP, as applicable), manufactured in accordance with the DMF, and the Specifications; 

“Affiliate” means: 
  

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

 

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

  

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

“API Value” means the dollar value for the API as specified in Schedule A hereto and for the purposes specified in
Article 4; 
 “Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the
province of Quebec, Canada or in Barcelona, Spain; 
 “cGMPs” means current Good Manufacturing Practices as described in:

  

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

  

	 	(b)	Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations, 

 together with
the latest Health Canada and FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time; 

“Deficiency Notice” shall have the meaning ascribed thereto in Section 5.2(a); 

“Effective Date” means the date first hereinabove mentioned; 

“Facility” means the manufacturing facility of INFAR, located at Ctra. N-II, Km. 680.6, 08389 Palafolls in Spain, where
manufacturing of the APls is under this Agreement shall take place; 
 “FDA” means the United States government department
known as the Food and Drug Administration; · 
 “Firm Orders” has the meaning specified in Section 5.1 (b); 

  

	[*]	Confidential treatment requested. 

  
 Page 3 of 20 

 EXECUTION COPY 
  

“Intellectual Property” includes, without limitation, rights in patents, patent applications, formulae, trade-marks,
trade-mark applications, trade-names, trade secrets, inventions, copyright, industrial designs, know-how; 
 “Minimum
Quantity” means a standard batch size of API to be manufactured and ordered. 
 “Quality Agreement” means the
agreement to be entered into between INFAR and AXCAN and setting out the quality assurance standards to be applicable by INFAR and the sharing of operational responsibilities between INFAR and AXCAN, which agreement shall be referred to hereto as
Schedule B; 
 “Specifications” means the file, which is agreed upon by AXCAN and INFAR, including, without limitation: 

 

	 	(a)	written specifications for the Active Pharmaceutical Ingredient, including density; 

  

	 	(b)	specifications described in the US Pharmacopeia and filed with the FDA; 

  

	 	(c)	packaging specifications; 

  

	 	(d)	shipping and storage requirements; 

  

	 	(e)	all environmental, health and safety information relating to the API, including material safety data sheets, all as updated, amended and revised from time to time by AXCAN in accordance with the terms of the Agreement;
and 

  

	 	(f)	any other technical information necessary to carry out the contracted operations correctly in accordance with the marketing authorisation and any other legal requirements. 

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

“Territory” means the geographic area of the United States and Canada; 

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

“Year” means, in the case of the first Year of this Agreement, a period commencing as and from the Effective Date and
terminating on December 31st, 2008, and thereafter a twelve-month period commencing upon completion of the immediately preceding Year. 
  

	1.2	Currency  

 Unless otherwise indicated, all monetary amounts are expressed in this
Agreement in Euros. 
  

	1.3	Sections and Headings  

 The division of this Agreement into Articles, sections,
subsections and Schedules and the insertion of headings are for convenience of reference only and shall not affect the 

  

	[*]	Confidential treatment requested. 

  
 Page 4 of 20 

 EXECUTION COPY 
  

	 	
interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or Schedule refers to the specified Section or Schedule to this Agreement. In this
Agreement, the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement and not to any particular part, Section, Schedule or the
provision hereof. 

  

	1.4	Singular Terms  

 Except as otherwise expressly provided herein or unless the
context otherwise requires, all references to the singular shall include the plural and vice versa. 
  

	1.5	Schedules 

 The following Schedules are attached to, incorporated in and form part
of this Agreement: 
 Schedule A - Active Pharmaceutical Ingredients and Pricing 

Schedule B - Quality Agreement 

ARTICLE 2 - INFAR’S OBLIGATIONS 

INFAR AGREES TO SUPPLY MESALAMINE USP/EP (AS APPLICABLE) TO AXCAN ON AN EXCLUSIVE BASIS IN AND FOR THE TERRITORY, FOR USE IN AND FOR SALES OF SUPPOSITORIES,
TABLETS OR OTHER PRODUCTS SOLD BY AXCAN IN AND FOR THE TERRITORY. 
  

	2.1	Standard of Performance  

 INFAR shall provide the API in accordance with;
(i) the current Drug Master File (DMF); (ii) the Specifications and cGMPs; and (iii) any other terms and conditions provided in the Quality Agreement. INFAR shall assure continued updates of Drug Master Files with the appropriate
regulatory agencies in the Territory. 
  

	2.2	Services Requirements 

  

	 	(a)	Account Management. Each of AXCAN and INFAR will assign representatives to manage this contract at the following levels: 

  

	 	(i)	Executive Sponsors: Top-level executives from both parties will be assigned to monitor this Agreement and interact with key personnel as needed. 

 

	 	(ii)	Account Managers (AXCAN’s Director of Procurement, INFAR’s Account Director and representatives of the company distributing the API, as the case may be) and to monitor and implement this Agreement, and work on
continuous improvement initiatives and on new API introductions. Account Managers will schedule periodic meetings to review, among other things, quality, technical, procurement and service issues. 

 

	 	(iii)	Designated Customer Service Representatives (CSR) to manage purchase orders, shipments, invoice issues and any other activities relating to AXCAN’s account that is not managed by the Account Managers.

  

	[*]	Confidential treatment requested. 

  
 Page 5 of 20 

 EXECUTION COPY 
  

 

	2.3	Continuous Improvement  

 Both parties will attempt to identify continuous
improvement opportunities and present it at business reviews. The parties will evaluate the opportunity of implementing such opportunities and advise accordingly. Improvement opportunities revolve around lead-time, cost (including component
procurement cost), efficiency and quality. It is agreed that necessary upfront investment and benefits resulting from such improvements will be shared in proportions to be agreed upon on a project-by-project basis. 

ARTICLE 3 - AXCAN’S OBLIGATIONS 
  

	3.1	Payment. 

 Pursuant to the terms of this Agreement, AXCAN shall pay for the API
according to the pricing specified in Schedule A hereto (such pricing being subject to adjustment in accordance with the terms hereof). 
  

	3.2	Volume. 

 Pursuant to the terms of this Agreement and in acknowledgement of the
exclusivity defined hereabove in Article 2, [*]. 
  

	3.3	Additional Volume. 

 Pursuant to the terms of this Agreement, and in
acknowledgement of the exclusivity defined hereabove in Article 2, AXCAN shall use commercially reasonable efforts to help qualify INFAR for the supply of mesalamine USP/EP (as applicable) for AXCAN’s 500 mg mesalamine tablets products in
Canada, taking into consideration that such qualification excludes clinical trials. AXCAN shall act in good faith and use commercially reasonable efforts to collaborate with INFAR for this qualification, including for engineering trials, validation
batches, stability studies on the finished product, analytical testing and preparation of filing to Health Canada. INFAR shall timely provide all reasonably required efforts, documentation and support with respect thereof and, without limitation,
shall allow and participate in any required audit. Should INFAR become duly qualified as a supplier of mesalamine USP I EP in Canada for AXCAN’s 500 mg mesalamine tablets products, in acknowledgement of the exclusivity defined above in Article
2 and INFAR’s efforts, [*]. 
 ARTICLE 4 - PRICING 

 

	4.1	Pricing  

 The pricing for the API provided pursuant to the terms of this
Agreement during any Year of this Agreement is specified in Schedule A. 

  

	[*]	Confidential treatment requested. 

  
 Page 6 of 20 

 EXECUTION COPY 
  

 

	4.2	[*] 

  

	4.3	Adjustments Due to Technical Changes  

 Amendments to the
Specifications requested by AXCAN will only be implemented following a technical and cost review by INFAR and are subject to AXCAN and INFAR reaching agreement as to revisions, if any, to the pricing specified in Schedule A necessitated by any such
amendment, as the case may be. If AXCAN accepts a proposed pricing change, the proposed change in the Specifications shall be implemented, and the pricing change shall become effective only with respect to those orders of API that are manufactured
in accordance with the revised Specifications. 
 ARTICLE 5 - ORDERS, FORECASTS, API DEFICIENCIES, RECORDS, 

INSPECTION AND ACCESS 
  

	5.1	Orders and Forecasts  

 AXCAN shall provide INFAR with the following: 

 

	 	(a)	concurrent with the execution of this Agreement, a written non-binding eighteen (18) months forecast of the volume of the API that AXCAN then anticipates will be required. Such forecast will be updated by AXCAN
monthly on a rolling eighteen (18) month basis and provided to INFAR no later than the 15th day of each month; 

  

	 	(b)	firm written orders (“Firm Orders”) for the API to be produced and delivered to AXCAN on a date not less than the necessary lead time to schedule and manufacture such API (12 weeks unless otherwise
mutually agreed upon in writing), calculated from the date that the Firm Order is submitted; 

  

	 	(c)	on or before March 1st in each Year commencing on March 1st 2009, and for investment evaluation
purposes only, AXCAN, if possible, shall provide INFAR with a written non-binding five year forecast of the volume of each API AXCAN then anticipates will be required to be produced and delivered to AXCAN during the five year period; and

  

	 	(d)	shipment instructions. 

  

	5.2	API Deficiencies  

  

	 	(a)	Inspection. AXCAN shall have the material manufactured by INFAR tested upon receipt thereof and, within sixty (60) days, shall give INFAR written notice (a “Deficiency Notice”) for APIs that
deviate from the Specifications or cGMPs. Should AXCAN fail to provide INFAR with written notice of its acceptance or rejection of the delivery within sixty (60) days of receipt of a delivery of APIs, unless reasonably beyond AXCAN’s
immediate control, then the delivery shall be deemed to have been accepted by AXCAN on the sixty-first day after delivery. 

  

	 	(b)	API Rejection. AXCAN has the right to reject and return, at the expense of INFAR, any portion of any shipment of APIs that deviates from the Specifications or cGMPs, without invalidating any remainder of such
shipment, to the extent that such deviation arises from INFAR’s failure to provide the API in accordance with this Agreement. 

  

	[*]	Confidential treatment requested. 

  
 Page 7 of 20 

 EXECUTION COPY 
  

 

	5.3	Records and Accounting by INFAR  

 INFAR shall keep records of the manufacture,
testing and shipping of the API, and retain samples of such API as are necessary to comply with manufacturing regulatory requirements applicable to INFAR, as well as to assist with resolving API complaints and other similar investigations. Copies of
such records and samples shall be retained for a period of one year following the date of API expiry, or longer if required by law. AXCAN is responsible for retaining samples of the API necessary to comply with the legal/regulatory requirements
applicable to AXCAN. 
  

	5.4	Inspection  

 AXCAN may inspect INFAR reports and records relating
to this Agreement during normal business hours and with reasonable advance written notice, provided a INFAR representative is present during any such inspection. INFAR shall promptly notify AXCAN of any inspections by any governmental agency
involving the API. 
  

	5.5	Access. 

 INFAR shall provide AXCAN with reasonable access at
mutually agreeable times, no more than once per Year unless for cause, to any of its Facility in which the API is manufactured, stored, handled or shipped in order to permit AXCAN’s verification of INFAR’s compliance with the terms of this
Agreement and with all applicable laws and regulations. For greater certainty, the right of access provided in this Section 5.5 shall not include a right to access or inspect INFAR’s financial records. 

ARTICLE 6 - TERM AND TERMINATION 
  

	6.1	Initial Term  

 This Agreement shall enter into force between the parties as of
the Effective Date and shall continue for a period of five (5) Years (the “Initial Term”) unless terminated earlier by one of the parties as provided herein. This Agreement shall automatically be renewed in increments of
twenty-four (24) months at the expiration of the Initial Term and any renewal period, as the case may be, unless a written notice of non-renewal is sent at least twelve (12) months before the expiration of the ongoing term. New business
shall be negotiated and mutually agreed upon on an ad-hoc basis and shall be formalized on an addendum to this contract. 
  

	6.2	Termination for Cause 

  

	 	(a)	 Either party at its sole option may terminate this Agreement upon written notice in circumstances where the other party has failed to remedy a
material breach of 

  

	[*]	Confidential treatment requested. 

  
 Page 8 of 20 

 EXECUTION COPY 
  

	 	
any of its representations, warranties or other obligations under this Agreement within thirty (30) days following receipt of a written notice (the “Remediation Period”) of
said breach that expressly states that it is a notice under this Section 6.2(a) (a “Breach Notice”). 

  

	 	(b)	Either party at its sole option may immediately terminate this Agreement upon written notice, without prior advance notice, to the other party in the event that (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 such other party; or (iii) this Agreement is assigned by such other party for the benefit of creditors.

  

	 	(c)	AXCAN may terminate this Agreement as to any API upon ninety (90) days’ written notice in the event that any governmental agency takes any action, or raises any objection, that prevents AXCAN from purchasing,
using or commercializing such API. 

  

	 	(d)	AXCAN may terminate this Agreement upon sixty (60) prior days’ written notice if recurring quality or compliance difficulties with the API and affecting the manufacturing of the associated finished product
occur. Recurring difficulties are defined as severe and repetitive or intermittent issues on the lots produced over a period of twelve (12) months and preventing from manufacturing the finished product. It is noted that INFAR shall deploy all
reasonable efforts to resolve such difficulties as fast as possible. Paragraph (a) above, however, may apply to the individual difficulty. 

  

	6.3	Obligations on Termination  

 If this Agreement expires or is terminated in whole
or in part for any reason, then AXCAN shall take delivery of and pay for all undelivered APIs that are manufactured and/or packaged pursuant to a Firm Order, at the price in effect at the time the Firm Order was placed. Any termination or expiration
of this Agreement shall not affect any outstanding obligations or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the parties may have under this Agreement and it shall not effect the
coming into force or the continuance in force of any provision hereof which is expressly or by implication intended to come into or continue in force on or after such termination. For greater certainty, and without prejudice to the generality of the
foregoing, termination of this Agreement for any reason shall not affect the obligations and responsibilities of the parties pursuant to Article 9, all of which survive any termination. 

ARTICLE 7 - REPRESENTATIONS, WARRANTIES AND COVENANTS  
  

	7.1	Authority 

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

  

	[*]	Confidential treatment requested. 

  
 Page 9 of 20 

 EXECUTION COPY 
  

 

	7.2	Permits  

 INFAR shall, for the whole term of this Agreement, obtain and maintain
all necessary permits, licenses and registrations required for it to perform its obligations to AXCAN under this Agreement. AXCAN shall be solely responsible for obtaining or maintaining, on a timely basis, any permits or other regulatory approvals
in respect of the API or the Specifications, including, without limitation, all marketing and post-marketing approvals. 
  

	7.3	Compliance with Laws  

 Each party, in connection with its performance under this
Agreement, shall comply with all applicable laws, rules, regulations and orders. 
  

	7.4	Warranty 

 INFAR represents and warrants that it will deliver API complying with
the DMF, the Specifications and cGMPs. 
 ARTICLE 8 - REMEDIES AND INDEMNITIES  

 

	8.1	Consequential Damages 

 Under no circumstances whatsoever shall either party be
liable to the other in contract, tort, negligence, breach of statutory duty or otherwise for any liability, damage, costs or expense of any kind incurred by the other party of an indirect or consequential nature. 

 

	8.2	Limitation of Liability  

 Except in circumstances where INFAR has failed to
provide the API in accordance with this Agreement, INFAR shall not be liable nor have any responsibility for any deficiencies in, or other liabilities associated with, the finished product containing the API, including, without limitation, the costs
and expenses of any recall of the finished product that (i) relates to the safety, efficacy or marketability of the finished product or any distribution thereof; (ii) is caused by actions of third parties occurring after the API is shipped
by INFAR pursuant to AXCAN’s instructions including, without limitation, any acts or omissions of AXCAN’s third party laboratory; (iii) is caused by deficiencies with respect to the part of the Specifications not provided by INFAR; or
(vi) is due to any other breach by AXCAN of its obligations under this Agreement. 
  

	8.3	Indemnification by INFAR  

 Subject to Sections 8.1 and 8.2, INFAR agrees to
defend, indemnify and hold AXCAN, its officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting from, or
relating to any claim of infringement or alleged infringement of any Third Party Rights in respect of the API, and any claim of personal injury or any damage to the extent that such injury or damage is the result of a breach of INFAR’s
representation and warranties contained herein or a failure by INFAR to provide the API in accordance with this Agreement, 

  

	[*]	Confidential treatment requested. 

  
 Page 10 of 20 

 EXECUTION COPY 
  

except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the negligence or wrongful act(s) of AXCAN, its officers, employees or agents or
Affiliates or a breach by AXCAN of its obligations under this Agreement. 
 In the event of a claim, AXCAN shall: (a) promptly notify
INFAR of any such claim; (b) use commercially reasonable efforts to mitigate the effects of such claim; and (c) reasonably cooperate with INFAR in the defence of such claim. 

 

	8.4	Indemnification by AXCAN  

 Subject to Section 8.1, AXCAN agrees to defend,
indemnify and hold INFAR, its officers, employees and agents harmless against any and all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) resulting from, or relating to
any claim of personal injury or property damage to the extent that such injury or damage is the result of a breach of any of AXCAN’s representations and warranties contained herein, or of deficiencies with respect to the Specifications, the
safety or efficacy of the finished product except to the extent that any such losses, damages, costs, claims, demands, judgments and liability are due to the negligence or wrongful act(s) of INFAR, its officers, employees or agents or a breach by
INFAR of its obligations under this Agreement. 
 In the event of a claim, INFAR shall: (a) promptly notify in writing AXCAN of any
such claims; (b) use commercially reasonable efforts to mitigate the effects of such claim; and (c) reasonably cooperate with AXCAN in the defence of such claim. 

ARTICLE 9 - CONFIDENTIALITY 
  

	9.1	Confidentiality  

  

	 	(a)	During the term of this Agreement and after termination or expiration of this Agreement for any reason the Receiving Party: 

  

	 	(i)	shall keep the Confidential Information confidential; 

  

	 	(ii)	may not disclose the Confidential Information to another person except with the prior written consent of the Disclosing Party or in accordance with sections 9.1 (b) and (c); and 

 

	 	(iii)	may not use the Confidential Information for a purpose other than the performance of its obligations under this Agreement. 

  

	 	(b)	During the term of this Agreement the Receiving Party may disclose the Confidential Information to its employees (a “Recipient”) to the extent that it is reasonably necessary for the purposes of this
Agreement. 

  

	 	(c)	The Receiving Party shall ensure that each Recipient is made aware of and complies with all the Receiving Party’s obligations of confidentiality under this Agreement as if the Recipient was a party to this
Agreement. 

  

	[*]	Confidential treatment requested. 

  
 Page 11 of 20 

 EXECUTION COPY 
  

 

	 	(d)	Sections 9.1 (a) to (c) do not apply to Confidential Information which: 

  

	 	(i)	is at the date of this Agreement or at any time after the date of this Agreement comes into the public domain other than through breach of this Agreement by the Receiving Party or a Recipient; 

 

	 	(ii)	can be shown by the Receiving Party to the Disclosing Party’s reasonable satisfaction to have been known by the Receiving Party before disclosure by the Disclosing Party to the Receiving Party; or

  

	 	(iii)	subsequently comes lawfully into the possession of the Receiving Party from another. 

  

	 	(e)	For the purposes of this section, “Confidential Information” means all information of a confidential nature disclosed (whether in writing, orally or by another means and whether directly or indirectly)
by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) whether before or after the date of this Agreement including, without limitation, information relating to the Disclosing Party’s
products, operations, processes, plans or intentions, product information, know-how, design rights, trade secrets, market opportunities and business affairs. 

  

	9.2	Ownership Rights  

 Each party agrees that it shall not claim to have any rights,
title or ownership in the Confidential Information of the other party or any discoveries or inventions or improvements based on or derived from the Confidential Information, and that rights, title and ownership in such Confidential Information of
the other party or any discoveries or inventions or improvements based on or derived from said Confidential Information shall vest with the other party. Without limiting the generality of the foregoing, the AXCAN technology and all Intellectual
Property rights of AXCAN related thereto shall form part of AXCAN’s Confidential Information. INFAR therefore agrees to promptly disclose to AXCAN any discoveries, or inventions or improvements based on or derived from AXCAN’s Confidential
Information (“Invention”). INFAR agrees to assign (and does hereby assign) to AXCAN, the sole and exclusive ownership in all such Invention and to sign all documents and do all things required to give effect thereto. This provision
is without prejudice to INFAR’s obligations under section 9 of the Agreement and under no circumstances can INFAR use AXCAN’s Confidential Information to pursue the development or commercialization of the Invention or disclose or interest
a third party into such Invention. 
  

	9.3	No Trademark Rights  

 Except as otherwise specifically provided for herein, no
right, express or implied, is granted hereby to a party to use in any manner the name or any other trade name or trade mark of the other party. 

  

	[*]	Confidential treatment requested. 

  
 Page 12 of 20 

 EXECUTION COPY 
  

ARTICLE 10 - DISPUTE RESOLUTION 
  

	10.1	Disputes  

 In the event of any dispute arising out of or in connection with this
Agreement, the parties shall first try to solve it amicably. In this regard, any party may send a notice of dispute to the other, and each party shall appoint, within ten (10) Business Days from receipt of such notice of dispute, a single
representative having full power and authority to solve the dispute. The representatives so designated shall meet as necessary in order to solve such dispute. If these representatives fail to solve the matter within one month from their appointment,
or if a party fails to appoint a representative within the ten (10) Business Day period set forth above, such dispute shall immediately be referred to the Chief Financial Officer or Chief Executive Officer (or such other officer as they may
designate) of each party who will meet and discuss as necessary in order to try to solve the dispute amicably. 
 Should the parties fail to
reach a resolution under this Section 10.1, the matter shall be settled by binding arbitration in Lausanne, Switzerland in accordance with the provisions of this Article 10, thereby excluding all recourses to any court of law whatsoever, except
for the purpose of filing the award, obtaining an order of enforcement for seeking provisional measures before or during arbitration, such as injunctions, as the case may be, or for the purpose of rendering the award executory. The dispute,
controversy or claim arising out of or relating to this Agreement, or the breach thereof, shall be determined by arbitration administered by the International Centre for Dispute Resolution in accordance with its International Arbitration Rules
(unless this section 10 provides otherwise), and the arbitration shall be conducted in English. The decision of the arbitrator(s) is final and binding on both parties. 
  

	10.2	Prior Notice-Single Arbitrator 

 It shall be a condition precedent to the right of
any party to submit a matter to arbitration pursuant to the provisions hereof to give not less than ten (10) days prior written notice to the other party of its intention to do so. During that ten (10) days delay, the parties shall
endeavour to jointly appoint a single arbitrator. In the event the dispute is of a technical, operational or scientific nature, the parties shall jointly appoint a mutually acceptable expert with adequate experience and expertise with respect to the
subject matter of the dispute. Upon the expiration of such ten (10) day period, and if the parties have failed to appoint a single arbitrator, the party who has given such notice may proceed to refer to dispute the arbitration as provided
herein. 
  

	10.3	Arbitrators  

 The party entitled to refer a matter to arbitration shall proceed
by appointing one (1) arbitrator and notifying the other party of such appointment. The other party shall, upon receiving such notice, appoint a second arbitrator, and the two (2) arbitrators shall, within fifteen (15) days of the
appointment of the second arbitrator, agree to the appointment of a third arbitrator who will act with them and be chair of the panel. In the event the dispute is of a technical, operational or scientific nature, the third arbitrator shall have
adequate experience and expertise with respect to the subject matter of the dispute. In the event that either party shall fail to appoint an arbitrator within thirty (30) days after the commencement of the arbitration proceeding, the arbitrator
shall be appointed by a judge. In the event of the failure of said two 

  

	[*]	Confidential treatment requested. 

  
 Page 13 of 20 

 EXECUTION COPY 
  

(2) arbitrators to agree within sixty (60) days after the commencement of the arbitration proceeding upon the appointment of the chairman, the chairman shall also be appointed by a judge of
the Swiss Federal Court, Lausanne on the application of either party. 
  

	10.4	Expenses  

 The expenses of each party, including legal and accounting fees, if
any, with respect to the arbitration, shall be borne by such Party, except to the extent otherwise directed by the arbitrator(s). The arbitrator(s) shall designate the party to bear the expenses of the arbitrator(s) or the respective amounts of such
expenses to be born by each party. 
 ARTICLE 11 - MISCELLANEOUS 

 

	11.1	Intellectual Property 

 AXCAN and INFAR hereby acknowledge that neither party has,
nor shall it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing. Each party agrees not to 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. 
  

	11.2	Insurance  

 Each party shall maintain commercial general liability insurance,
which adequately covers the obligations of that party under this Agreement through the term of this Agreement, which insurance shall afford limits of not less than [*] per occurrence and per Year in the aggregate, as well as adequate products
liability and property insurance. If requested each party will provide the other with a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the
limits of liability. The insurance certificate shall further provide for a minimum of thirty days’ written notice to the insured of a cancellation of, or material change in, the insurance. 

 

	11.3	Independent Contractors  

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

	11.4	No Waiver  

 Either party’s failure to require the other party to comply with
any provision of this Agreement shall not be deemed a waiver of such provision or any other provision of this Agreement. 
  

	11.5	Assignment  

 INFAR may not assign this Agreement or any of its rights or
obligations hereunder except with the written consent of AXCAN, such consent not to be unreasonably withheld. For 

  

	[*]	Confidential treatment requested. 

  
 Page 14 of 20 

 EXECUTION COPY 
  

greater certainty, INFAR may arrange for subcontractors to perform specific services arising under this Agreement provided that INFAR remains responsible to AXCAN under this Agreement. 

AXCAN may assign this Agreement or any of its rights or obligations hereunder without approval from INFAR; provided, however, that AXCAN shall
give prior written notice of any assignment to INFAR and that any assignee shall covenant in writing with INFAR to be bound by the terms of this Agreement. 

Notwithstanding the foregoing provisions of this Section 11.5, 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, provided that such assignee executes an agreement with the non-assigning party hereto whereby it agrees to be bound hereunder. 

 

	11.6	Force Majeure  

 Neither party shall be liable for the failure to perform its
obligations under this Agreement if such failure is occasioned by a cause or contingency beyond such party’s reasonable control, including, but not limited to, riots, wars, acts of terrorism, fires, floods, storms, strikes, interruption of or
delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity acting within colour of right (a “Force Majeure Event”). A
party claiming a right to excused performance under this Section 11.6 shall immediately notify the other party in writing of the extent of its inability to perform, which notice shall specify the occurrence beyond its reasonable control that
prevents such performance. Neither party shall be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) that would otherwise be due and payable under this Agreement. 

 

	11.7	Additional API  

 Additional APIs may be added to this Agreement and such
additional APIs shall be governed by the general conditions hereof with any special terms (including, without limitation, price) governed by a written addendum hereto. 

  

	[*]	Confidential treatment requested. 

  
 Page 15 of 20 

 EXECUTION COPY 
  

 

	11.8	Notices  

 All communications and other notices under this Agreement shall be in
writing and shall be considered as duly given and received upon the date of delivery, if delivered personally or sent by courier or registered letter with return receipt or transmitted by fax, with confirmation of transmittal receipt, to the parties
at the following addresses or fax numbers (or at any other address or fax number which the parties shall have indicated by giving notice thereof in the ways set forth above): 
  

	 	(a)	as to AXCAN, to: 

  

			
	AXCAN PHARMA INC.
	597 boulevard, Laurier
	Mont-Saint-Hilaire, Quebec J3H 6C4
	Canada
	Attention: Executive Director, Global Supply Chain
	Tel. No:	 	(450) 467-5138
	Fax No:	 	(450) 464-9979

 With a copy to: General Counsel (same address and fax number) 

 

	 	(b)	as to INFAR, to: 

  

			
	INFAR
	Ctra. N-II, Km. 680.6
	08389 Palafolls
	Barcelona, Spain
	Attention: Marta Ferrer
	Tel. No:	 	00-34-0937650738
	Fax No.:	 	00-34-0937650435

  

	11.9	Severability. 

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

	11.10	Entire Agreement. 

 This Agreement, together with the Quality Agreement
constitutes the full, complete, final and integrated agreement between the parties hereto relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions or understandings with
respect to the subject matter hereof. Any modification, amendment or supplement to this Agreement must be in writing and signed by authorized representatives of both parties. 
  

	11.11	No Third Party Benefit or Right. 

 For greater certainty, nothing in this
Agreement shall 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. 
  

	11.12	Public Announcements. 

 Subject to Article 9 and except as required by applicable
law, the parties shall not issue any press release, publicity or other similar form of public announcement related to this Agreement, or disclose the terms hereof, without the prior written consent of the other party, such consent to be provided in
such party’s reasonable discretion. 

  

	[*]	Confidential treatment requested. 

  
 Page 16 of 20 

 EXECUTION COPY 
  

 

	11.13	Execution in Counterparts. 

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

	11.14	Governing Law. 

 This Agreement shall be governed, construed and enforced in
accordance with the laws in force in Spain. 

  

	[*]	Confidential treatment requested. 

  
 Page 17 of 20 

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

									
	INFAR	 		 	AXCAN PHARMA INC.
			
	 /s/ Francisco Ferrer Escolar
	 		 	 /s/ Frank AGM Verwiel

	Name:	 	Francisco Ferrer Escolar	 		 	Name:	 	Frank A.G.M. Verwiel
	Title:	 		 		 	Title:	 	President and CEO
	Duly authorized	 		 	Duly authorized
				
		 		 		 	 /s/ Steve Gannon

		 		 		 	Name:	 	Steve Gannon
		 		 		 	Title:	 	Senior Vice President and CFO
		 		 		 	Duly authorized

  

	[*]	Confidential treatment requested. 

  
 Page 18 of 20 

 SCHEDULE A 

API AND PRICING 
  

									
	 Item no.
	  	 Item Description
	  	Approximate
Batch Size	  	Yearly API
Volume (Kg)	  	Pricing
(€ per Kg)
		  	 Mesalamine
	  	[*]	  	[*]	  	[*]
		  		  		  	[*]	  	[*]
		  		  		  	[*]	  	[*]
		  		  		  	[*]	  	[*]
		  		  		  	[*]	  	[*]

  
 Page 19 of 20 

 EXECUTION COPY 
  

SCHEDULE B 

QUALITY AGREEMENT 
 Quality
Agreement to be negotiated and signed in 2008. 

  

	[*]	Confidential treatment requested. 

  
 Page 20 of 20

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00224-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00224-of-00352.parquet"}]]