Document:

Pharmaceutical Product Supply Agreement

 Exhibit 10.32 
 Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit
has been filed separately with the Securities and Exchange Commission. 
 PHARMACEUTICAL PRODUCT 
 SUPPLY AGREEMENT 
 Dated
January 27, 2005 
 By and Between 
 DSM PHARMACEUTICALS, INC. 
 and 
 BARRIER THERAPEUTICS, INC. 

 TABLE OF CONTENTS 
  

					
	Article 1:	 	DEFINITIONS	  	1
			
	Article 2:	 	SALE AND PURCHASE OF PRODUCT	  	5
			
	Article 3:	 	COORDINATORS; DIVESTMENT OF PRODUCTS	  	6
			
	Article 4:	 	EQUIPMENT; ACTIVE PHARMACEUTICAL INGREDIENTS; EXCIPIENTS; ARTWORK	  	7
			
	Article 5:	 	WARRANTIES; SPECIFICATIONS; QUALITY AGREEMENT	  	8
			
	Article 6:	 	FORECASTS; ORDERS	  	11
			
	Article 7:	 	PURCHASE OF PRODUCT; DELIVERIES	  	12
			
	Article 8:	 	PRICE; PRICE INCREASES; ADDITIONAL PAYMENTS	  	13
			
	Article 9:	 	RECALLS	  	15
			
	Article 10:	 	VALIDATION; REGULATORY 10.1 Validation	  	15
			
	Article 11:	 	TERM; TERMINATION	  	17
			
	Article 12:	 	CLAIMS 12.1 Claims	  	18
			
	Article 13:	 	INDEMNIFICATION OF THIRD PARTY CLAIMS	  	20
			
	Article 14:	 	CONFIDENTIALITY	  	21
			
	Article 15:	 	INTELLECTUAL PROPERTY	  	22
			
	Article 16:	 	FORCE MAJEURE	  	23
			
	Article 17:	 	LEGAL COMPLIANCE; AUTHORIZATION,	  	24
			
	Article 18:	 	PRESS RELEASES; USE OF NAMES	  	24
			
	Article 19:	 	MISCELLANEOUS	  	25

  

 -i- 

 PHARMACEUTICAL PRODUCT SUPPLY AGREEMENT 
 By and Between Barrier Therapeutics, Inc. 
 And DSM Pharmaceuticals, Inc.

 THIS PHARMACEUTICAL PRODUCT SUPPLY AGREEMENT is made effective as of this 28th day of January, 2005, by and between BARRIER
THERAPEUTICS, INC., a corporation organized under the laws of the State of Delaware and having a place of business at 600 College Road East, Suite 3200, Princeton, New Jersey 08540-6697 (“Barrier”); and DSM PHARMACEUTICALS,
INC., a corporation organized under the laws of the State of Delaware and having a place of business at 5900 NW Greenville Blvd., “Greenville, North Carolina 27834 (“DSM”) (each individually a “Party” and
collectively the “Parties”). 
 W I T N E S S: 
 WHEREAS, Barrier wishes to distribute commercially a certain pharmaceutical product known as Zimycan ointment in finished dosage form for human use; and 
 WHEREAS, DSM has the experience and expertise necessary to perform pharmaceutical development, manufacturing, packaging, analytical testing and quality assurance services
for the manufacturing, labeling and packaging of such product for sale to Barrier; and 
 WHEREAS, Barrier desires DSM to perform such services and to supply
such product to Barrier; and DSM desires to perform such services and to sell such product to Barrier, all on the terms and conditions set forth in this Agreement; 
 NOW, THEREFORE, in consideration of the mutual covenants and promises set forth herein, the Parties agree as follows: 
 ARTICLE 1:
DEFINITIONS 
 The following terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes of this
Agreement: 
  

	1.1	Acquisition Cost. “Acquisition Cost” shall mean the actual invoiced price paid by either Party to any Third Party for acquiring Active Pharmaceutical Ingredients,
Excipients or packaging materials hereunder, including, but not limited to, shipping and handling costs and customs duties incurred and paid by such Party to any Third Party in connection with the acquisition of Active Pharmaceutical Ingredients,
Excipients or packaging materials, as the case may be. 

  

	1.2	Active Pharmaceutical Ingredients/API. “Active Pharmaceutical Ingredients” or “API” shall mean the active pharmaceutical ingredients for the Product as
set forth on Exhibit 3 attached hereto, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time by mutual agreement of the Parties. 

	1.3	Affiliate. “Affiliate” shall mean any corporation or non-corporate entity which directly or indirectly controls, is controlled by, or is under common control with a
Party. A corporation or non-corporate entity shall be regarded as in control of another corporation if it owns or directly or indirectly controls at least fifty percent (50%) of the voting stock of the other corporation; or (a) in the
absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (b) in the case of a non-corporate entity, the power to direct or cause the direction of the management and policies of such corporation or
non-corporate entity, as applicable. 

  

	1.4	Agreement. “Agreement” shall mean this Supply Agreement. 

  

	1.5	Barrier Intellectual Property. “Barrier Intellectual Property” shall mean any inventions, discoveries, patents, patent applications, technology, know-how,
trademarks, information, data, writings, and other property, in any form whatsoever, which are provided to DSM by and/or on behalf of Barrier, or which are used by DSM with respect to its performance hereunder, and which were owned by and/or
licensed to Barrier prior to being provided to DSM. 

  

	1.6	Barrier’s Regulatory Documentation. “Barrier’s Regulatory Documentation” shall mean documentation which Barrier has filed with regulatory authorities
relating to the formulation of the Product, and any supplements to such documentation as may be filed during the term hereof, including the NDA. 

  

	1.7	CGMP. “CGMP” means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA in
accordance with FDA regulations, guidelines, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended from time to
time. 

  

	1.8	Commercial Product. “Commercial Product” shall mean Product supplied hereunder intended for commercial sale and/or human use. 

  

	1.9	Contract Year: “Contract Year” shall mean the period of twelve (12) successive calendar months commencing on January 1, 2005 and each successive twelve
(12) month period thereafter. 

  

	1.10	Delivery Date. “Delivery Date” shall mean a date for which delivery of Product is stated in a purchase order. 

  

	1.11	Developments. “Developments” means any and all inventions, discoveries, know-how, information, data, writings, and other intellectual property, in any form
whatsoever, both tangible and intangible, developed by DSM or by Barrier, or both, in the course of performance under this Agreement. 

  

	1.12	Development Product. “Development Product” shall mean Product not intended for commercial sale. 

  

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	1.13	DSM Intellectual Property. “DSM Intellectual Property” shall mean any inventions, discoveries, patents, patent applications technology, know-how, trademarks,
information, data, writings, and other property in any form whatsoever which are provided to Barrier by and/or on behalf of DSM or which are used by Barrier with respect to its performance hereunder, and which were owned by or licensed to DSM prior
to being provided to Barrier. 

  

	1.14	Effective Date. “Effective Date” shall mean the date appearing at the beginning of this Agreement. 

  

	1.15	Excipients. “Excipients” shall mean the raw materials, other than Active Pharmaceutical Ingredients and packaging, required to manufacture the Product in accordance
with the Product Specifications, as such Excipients are listed on Exhibit 3 attached hereto, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time by mutual
agreement of the Parties. 

  

	1.16	FD&C Act. “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as amended. 

  

	1.17	FDA. “FDA” shall mean the United States Food and Drug Administration, or any successor entity. 

  

	1.18	Firm Purchase Commitment. “Firm Purchase Commitment” shall mean the obligation of DSM to supply and of Barrier to purchase, the quantities forecasted by Barrier in
accordance with Section 6.3 hereinafter. 

  

	1.19	First Commercial Sale. “First Commercial Sale” shall mean the first commercial sale of the Commercial Product by Barrier or its Affiliates in the Territory
following Product Approval. 

  

	1.20	Initial Term. “Initial Term” shall have the meaning set forth in Section 11.1 hereof. 

  

	1.21	Lot. “Lot” shall mean any of the following: (a) a development/clinical trial lot of Product; (b) a Validation Lot; or (c) a Commercial Product lot

  

	1.22	Maximum Quantities. “Maximum Quantities” shall have the meaning set forth in Section 6.2. 

  

	1.23	Minimum Quantities. “Minimum Quantities” shall have the meaning set forth in Section 2.2 hereof. 

  

	1.24	Monthly Forecast. “Monthly Forecast” shall have the meaning set forth in Section 6.2. 

  

	1.25	NDA. “NDA” shall mean New Drug Application as filed with the FDA. 

  

 3 

	1.26	Packaging Specifications. “Packaging Specifications” shall mean the packaging and labeling specifications for the Product which will be attached hereto as
Exhibit 4 and made a part hereof, as such specifications may be amended from time to time by mutual agreement of the Parties. 

  

	1.27	Product. “Product” shall mean Zimycan ointment packaged in a 30gm tube or such other package sizes as may be mutually agreed upon by the Parties from time to time.

  

	1.28	Product Approval. “Product Approval” shall mean final FDA approval of Barrier’s New Drug Application (“NDA”) or other Regulatory Documentation.

  

	1.29	Product Price. “Product Price” shall mean the Commercial Product price set forth in Exhibit 1 attached hereto and made a part hereof, as such price may be
amended from time to time in accordance with this Agreement. 

  

	1.30	Product Specifications. “Product Specifications” shall mean the specifications for the Product which will be attached hereto as Exhibit 5 and made a part
hereof, as determined in accordance with the analytical methodology agreed upon by the Parties, as such specifications may be amended from time to time by mutual agreement of the Parties, including without limitation such amendments as may be
required to obtain Product Approval. 

  

	1.31	Quality Agreement. “Quality Agreement” shall mean the Quality Agreement, as further defined in Section 5.6, which shall be substantially in the form of
Exhibit 6 hereto. 

  

	1.32	Specifications. “Specifications” shall mean the Product Specifications and the Packaging Specifications. 

  

	1.33	Territory. “Territory” shall mean the United States of America, and its territories and possessions and Europe. 

  

	1.34	Third Party. “Third Party” shall mean any Party other than Barrier, DSM and their respective Affiliates. 

  

	1.35	Unit. “Unit” shall mean a single tube of 30gm of Product or such other size as may be mutually agreed upon by the Parties from time to time.

  

	1.36	Validation Activities. “Validation Activities” shall mean those activities to be performed by DSM prior to the First Commercial Sale including, but not limited to,
process qualification of content uniformity, analytical testing, preparation of validation technical reports, cleaning validation, manufacturing and testing of Validation Lots. 

  

	1.37	 Validation Lots. “Validation Lots” for a dosage form shall mean shall mean the initial number of Lots, which shall be at least three (3) Lots
or such additional 

  

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Lots as mutually agreed, of the Product which are manufactured by DSM during the course of the Validation Activities. 

 ARTICLE 2: SALE AND PURCHASE OF PRODUCT 
  

	2.1	Production Forecasts and Purchase Orders. During each Contract Year throughout the term of this Agreement, DSM agrees to manufacture and sell to Barrier, and Barrier agrees
to purchase from DSM, on a non-exclusive basis, Commercial Product for sale and/or distribution within the Territory, in accordance with the terms and subject to the conditions of this Agreement, including the Exhibits hereto.

  

	2.2	Minimum Contract Quantities. DSM shall be obligated to supply, and Barrier shall be obligated to purchase, (i) the Firm Purchase Commitment set forth in Section 6.3
and, to the extent not included in the Firm Purchase Commitment, (ii) the following *** for the term of this Agreement, in ***: 

  

			
	 Contract Year
	  	 Minimum Quantity

		
	 ***
	  	***
		
	 ***
	  	***
		
	 ***
	  	***
		
	 ***
	  	***
		
	 ***
	  	***

 Unless the Parties shall mutually agree to additional quantities, the maximum annual quantity which
DSM shall be required to supply, and which Barrier may purchase, during the term of this Agreement shall be ***. In the event that the Firm Purchase Commitment or the *** are not purchased by Barrier, Barrier shall pay DSM’s Product Price per
Unit for deficient quantities. It is specifically agreed that the *** set forth in this Section 2.2 shall be reduced in any Contract Year by the quantity of Commercial Product which DSM is unable to supply within ninety (90) days of any
Delivery Date during such Contract Year unless DSM’s inability to supply is attributable to Barrier or its API supplier. 
  

	2.3	Development/Clinical Trials. DSM agrees to supply Product as requested by Barrier for development activities and clinical trials in accordance with the prices set forth in
Exhibit 8, subject to adjustment as set forth in Section 8.2 hereof. Upon DSM’s completion of production of Validation Lots and pre-launch Commercial Product Lots prior to the First Commercial Sale, Barrier shall pay DSM *** of the
Product Price for such Lots. The remaining *** of the Product Price shall be paid to DSM upon shipment of the Product or upon other disposition of the Lots if commercial release is not finalized. 

  

	2.4	 Disclosure/Development of Health Risk Data. Barrier shall be responsible for disclosing to DSM all information available to it regarding health risks which
may be involved in manufacturing any Product hereunder utilizing specified Active 

  

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Ingredients, Excipients, and other components, including without limitation industrial hygiene data, industrial hygiene analytical methods, exposure
limitations for workers involved in production, toxicology reports, and other health-related data. If reasonable industrial hygiene data is not available, DSM may develop reasonable data at Barrier’s expense 

 ARTICLE 3: COORDINATORS; DIVESTMENT OF PRODUCTS 
  

	3.1	Within ten (10) days after the Effective Date, Barrier and DSM shall each appoint an authorized representative and a backup representative (“Coordinators”) for
the exchange of all communications, other than legal notices, related to the manufacturing, labeling and packaging of the Product. Each Party shall provide notice to the other Party as to the name and title of the individuals so appointed. Each
Party may replace its Coordinators at any time for any reason by providing written notice to the other Party in accordance with Section 19.10 hereof. 

  

	3.2	Divestment of Products. If during the term of this Agreement, Barrier elects to assign or otherwise divest to any Third Party its drug rights to any Product (the
“Divested Product”) included in this Agreement, Barrier shall so advise DSM. Although the terms and conditions of such divestment shall be completely within the control of Barrier, the Parties agree that the terms and conditions of further
development and/or manufacturing by DSM of such Divested Product under this Agreement shall be subject to renegotiation between DSM and Barrier and/or the Third Party transferee of such drug rights. 

  

	 	3.2.1	Barrier acknowledges and agrees that the terms of pricing, delivery, allocation of liability, and other terms set forth in this Agreement are specific to this Agreement and the
Parties hereto, and may not be appropriate or equitable as applied to any Third Party. DSM agrees to negotiate in good faith to reach agreement with such Third Party in respect of continuation of any Divested Product under this Agreement.

  

	 	3.2.2	Pending transfer of any Divested Product hereunder to a Third Party, Barrier agrees to be responsible for any Firm Purchase Commitments or *** requirements which have accrued
hereunder in respect of such Divested Product. Barrier also agrees to be responsible for payment and FDA compliance with respect to any Divested Product until such time as Barrier and the Third Party have completed the transfer by formal written
assignment. 

 ARTICLE 4: EQUIPMENT; ACTIVE PHARMACEUTICAL INGREDIENTS; EXCIPIENTS; ARTWORK 
  

	4.1	Equipment. Equipment owned by DSM and located at DSM’s Greenville, North Carolina facility, shall not be dedicated to any single customer, but shall be available for
manufacturing of product according to DSM’s manufacturing processes requirements. 

  

 6 

	 	4.1.1	Barrier and DSM shall mutually agree on the terms and conditions of any special equipment required to be purchased for the processing of the Product. Equipment which Barrier has
agreed to purchase, and for which it shall be financially responsible as to capital modifications is identified in Exhibit 2 and shall be dedicated to the production of the Product. Barrier may at times authorize DSM, with DSM’s
approval, to select and order equipment that will be invoiced directly to Barrier. DSM shall be responsible for installing and qualifying at its facility, any and all new or used equipment, molds, and tooling necessary for the manufacturing,
packaging, and labeling of the Product. 

  

	 	4.1.2	Equipment identified to be purchased by Barrier for the Product and to be installed at DSM is identified in Exhibit 2. DSM shall obtain Barrier’s prior written approval
for all costs and expenses associated with such installation and qualification (including without limitation labor and engineering costs) and Barrier shall reimburse DSM for all such reasonable costs within thirty (30) days of receiving
DSM’s invoice(s) therefore. 

  

	 	4.1.3	Title to, and risk of loss of, all such equipment, molds and tooling paid for by Barrier shall be retained by Barrier, provided that all such equipment, molds and tooling shall
remain at DSM’s facility for use by DSM during the term of this Agreement. Following the termination of this Agreement, at Barrier’s election, Barrier may, at its expense, remove the equipment. 

  

	 	4.1.4	DSM shall be responsible for routine maintenance and servicing of such equipment so long as such equipment remains at DSM’s facility, including any non-routine maintenance due
to DSM’s negligence or willful misconduct. Barrier shall be responsible for the cost of non-routine maintenance and servicing of such equipment (such as major repairs and parts replacement), except to the extent caused by DSM’s negligence
or willful misconduct. DSM shall notify Barrier prior to the performance of any non-routine maintenance or servicing, and Barrier shall directly pay or promptly reimburse DSM (as the case may be) for any such maintenance or servicing costs that
Barrier has authorized to be incurred and for which it is responsible. 

  

	4.2	Active Pharmaceutical Ingredients and Excipients Supply. DSM shall, as part of the Product Price, supply Active Pharmaceutical Ingredients and Excipients for production of
the Product as well as all other materials required to manufacture, test, package, label and release the Product. 

  

	4.3	Artwork. At least (a) one hundred and twenty (120) days prior to the first Delivery Date, unless otherwise required by active ingredient, excipient, and packaging
material lead times, and from time to time thereafter with respect to the Product as needed, Barrier shall provide at no cost to DSM, final camera ready artwork for all packaging components to be used in the manufacture of the Product, which artwork
shall meet the Packaging Specifications. 

  

 7 

	4.4	Vendors Designated By Barrier. The Parties agree that Barrier shall rely on DSM’s choice of vendors and shall not designate vendors for the supply of Active
Pharmaceutical Ingredients, Excipients, and other materials required for the production and/or packaging of Product hereunder. 

 ARTICLE 5:
WARRANTIES; SPECIFICATIONS; QUALITY AGREEMENT 
  

	5.1	Warranties by DSM. DSM warrants to Barrier that the Commercial Product, at the time of sale and shipment to Barrier by DSM, (a) will conform to the Specifications as
then in effect, (b) will have been manufactured in compliance with all applicable laws and regulations and in accordance with CGMPs; (c) will not be (i) adulterated or misbranded by DSM within the meaning of the FD&C Act or
(ii) an article that may not be introduced into interstate commerce under the provisions of Sections 404 or 505 of the FD&C Act; and (d) shall have a ***. If Barrier elects to conduct its own batch record reviews, the remaining shelf
life required hereunder shall be correspondingly reduced for the period of time required by Barrier for such review. DSM further warrants that none of employees or representatives who will perform services pursuant to this Agreement have been
debarred or notified that they are under consideration to be debarred by the United States Food and Drug Administration from working in or providing services to any pharmaceutical or biotechnology company under the Generic Drug Enforcement Act of
1992, as amended. 

  

	5.2	Disclaimer by DSM. DSM expressly disclaims (a) any warranty that the Product (i) will be merchantable, (ii) will be fit for any particular purpose, or
(iii) will not violate or infringe the patent or other intellectual property rights of third Parties; (b) any other warranties with respect to the Product, express or implied, except as expressly stated in this Agreement; and (c) any
warranties in respect of the formulation, composition, use, or distribution of the Product or in respect of the marketing and/or sale of the Product to third parties. 

  

	5.3	 Warranties by Barrier. Barrier represents and warrants to DSM that (a) the formulation, composition, use, distribution, marketing, and/or sale of the
Product shall comply with regulatory requirements and applicable law, and that Barrier will maintain all obligations with respect thereto; (b) that Barrier will comply with applicable law and that it will keep DSM fully informed of any
development which would affect DSM’s production of the Product hereunder; (c) that in the event Barrier ships Product outside of the United States, Barrier will comply fully with all export administration and control laws and regulations
of the United States government as may be applicable to the export, resale or other disposition of any Products purchased from DSM; (d) that Products manufactured in accordance with the Specifications will not infringe any patent or other
intellectual property right of any Third Party; (e) that Excipients, Active Pharmaceutical Ingredients, and any production processes provided or specified 

  

 8 

	 	 
by Barrier will be suitable for the production of the Product and (f) that Barrier has disclosed all information available to it regarding health risks
which may be involved in manufacturing the Product hereunder utilizing the specified Active Ingredients, Excipients, and other components. 

  

	5.4	Limitation of Liability. Notwithstanding the foregoing warranties and representations and the further obligations of the Parties hereunder, in no event shall either Party be
liable to the other Party for incidental, indirect, special, consequential or punitive damages, including without limitation any claim for damages based upon lost profits or lost business opportunity. Except for the obligations of indemnity as set
forth in Article 13 with respect to (i) claims for personal injury, illness or death resulting from use of or exposure to a Product supplied hereunder, (ii) claims of patent infringement, and (iii) claims arising out of Barrier’s
failure to inform DSM of health risks pursuant to Section 2.4, above, which are not subject to the following limitation, aggregate damages for which either Party shall be liable to the other hereunder, shall *** with respect to *** and ***
any *** hereunder, *** of the *** such ***. The foregoing limitations shall not apply if the damages otherwise subject to limitation result from the gross negligence or willful misconduct of either Party. 

  

	5.5	Specification Changes. 

  

	 	5.5.1	In the event Barrier changes the Specifications, Barrier shall promptly advise DSM in writing of such changes, and in the event that such changes directly impact DSM’s
scheduling or costs, DSM shall promptly advise Barrier as to any scheduling and/or price adjustments caused by such changes. Prior to implementation of such changes, the Parties agree to negotiate in good faith in an attempt to reach agreement on
(a) the new price for any Product which embodies such changes, , and any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). 

 

	 	5.5.2	Barrier agrees to reimburse DSM for the reasonable expenses incurred by DSM as a result of such changes, including, but not limited to, reimbursing DSM for its validation and
development costs, capital expenditure costs and costs for any packaging components or other materials rendered unusable as a result of such changes which were reasonably purchased or incurred in reliance on Barrier’s forecasts; provided, in
each case that DSM is not able to utilize any such equipment or materials for its other customers. 

  

	 	5.5.3	 If during the term of this Agreement Barrier amends or is required by law to amend the Specifications so as to render the Active Pharmaceutical Ingredients,
Excipients and/or packaging components for the Product obsolete, Barrier shall (a) at Barrier’s option, purchase from DSM, at DSM’s Acquisition Cost, that amount of inventory of Excipients and packaging components so rendered
obsolete, or (b) accept DSM’s return 

  

 9 

	 	 
of such materials to Barrier and reimburse DSM any restocking fees incurred; and Barrier shall also purchase from DSM, at the applicable Product Price, that
amount of inventory of Product which is rendered obsolete. In addition to reimbursement of DSM’s Acquisition Cost for obsolete inventories, Barrier shall also *** for *** the *** or ***of ***. 

  

	 	5.5.4	DSM shall not make any change to the Specifications without Barrier’s prior written consent. 

  

	5.6	Quality Agreement. The Quality Agreement attached hereto as Exhibit 6 (“Quality Agreement”) further details the quality assurance obligations and
responsibilities of the Parties with respect to the Product. Notwithstanding anything to the contrary in this Agreement or in any other document or agreement, in the event of a conflict between this Agreement and the Quality Agreement, this Supply
Agreement shall govern and control. 

  

	5.7	Duty of Cooperation. The Parties acknowledge that production of pharmaceutical products is inherently complex and requires close attention to all aspects of the
Specifications, Excipients, Active Pharmaceutical Ingredients, production, storage, and shipment (collectively, “Process Requirements”). The Parties further acknowledge that DSM, as manufacturer of the Product, and Barrier, as distributor
of the finished Product, have significant regulatory obligations. Accordingly, the Parties agree to comply with applicable law as to their respective obligations and to cooperate with each other to maintain regulatory compliance hereunder. The
Parties further agree to notify each other promptly of any known problems with respect to Process Requirements and/or regulatory obligations and to resolve such problems in a prompt and efficient manner so as to permit continued production and
shipment of conforming Product, in accordance with all applicable regulatory requirements. Costs for correction of any such Process Requirements shall be allocated between the Parties in a fair and equitable manner and in accordance with the
respective obligations of the Parties hereunder and under any related agreements. If Barrier elects to delay or cease production of the Product, for any period of time and for any reasons (except for delays or cessation of production caused by DSM),
it shall promptly notify DSM; and Barrier shall reimburse DSM for (i) DSM’s costs incurred prior to or during such period of delay, including DSM’s Acquisition Costs for the unused inventories of Excipients, Active Pharmaceutical
Ingredients, plus *** and finished Product produced in accordance with Barrier’s forecasts, and (ii) DSM’s reasonable costs for services in resolving problems with Process Requirements which are beyond the obligation or reasonable
control of DSM (and only if such costs for services are directly related to the cessation or delay in production for the particular batch run in question). 

  

	ARTICLE	6: FORECASTS; ORDERS 

  

	6.1	 Long Term Forecast. Within thirty (30) days after the Effective Date, Barrier shall deliver to DSM a non-binding five (5) year forecast of
Barrier’s unit requirements 

  

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for Commercial Product for each Contract Year during the Initial Term. Such long-term forecast shall thereafter be updated every six (6) months (as of
June 1 and December 1) during the Term of this Agreement. If DSM is unable to accommodate any portion of the forecast, it shall notify Barrier and the Parties shall agree on any revisions to the forecast. 

  

	 6.2
	 Monthly Forecast. Within thirty (30) days of the Effective Date, Barrier shall submit to DSM a written
non-binding estimate of its monthly requirements for Product for each of the next succeeding twenty-four (24) months (the “Monthly Forecast”). The Monthly Forecast shall be updated monthly on the third (3rd) day of the month on a twenty-four (24) month rolling basis. For the initial forecast received by DSM, DSM shall
respond within thirty (30) days of the receipt thereof if quantities therein stated exceed the maximum quantities set forth in Section 2.2, above, as allocated on a monthly basis (the “Maximum Quantities”). Thereafter, upon
receipt of the Monthly Forecast, DSM shall respond within five (5) days if any additional quantities are included within the forecast for any months previously forecasted, or if quantities are stated for any new month in the Monthly Forecast
which exceed the Maximum Quantities for such month. If DSM is unable to accept such additional quantities, such additional quantities shall be removed from the Monthly Forecast. If Barrier is not in agreement with DSM’s revisions, it shall
respond in writing to DSM within five (5) calendar days; and the Parties shall negotiate in good faith to resolve any issues in respect of quantities. If DSM does not receive a response within five (5) calendar days, such quantities shall
be deemed to have been approved and accepted by Barrier. 

  

	6.3	Firm Purchase Commitment. The forecast of the most current three (3) month period shall always constitute a firm purchase commitment (the “Firm Purchase
Commitment”) which shall state in detail the quantities of Products ordered and the required delivery dates, and shall be binding on the Parties regarding Products to be purchased. The second three (3) month period (months four
(4) through six (6)) of the Monthly Forecast shall also constitute a Firm Purchase Commitment; however, the quantities stated for such months shall, at Barrier’s sole option, be subject to *** in each *** until ****** of the ***, at
which point the ***. The forecast for the remaining eighteen (18) month period of the Monthly Forecast is for planning purposes only and shall not constitute a commitment to purchase or supply Product. In the event that Barrier does not
ultimately purchase the Firm Purchase Commitment as herein provided or the *** as provided in Section 2.2, it shall be obligated to pay to DSM the Product Price per Unit for any deficient quantities. 

  

			
	Month	  	Allowable Forecast
Variation
	 1–3
	  	***
	 4
	  	***%
	 5
	  	***%
	 6
	  	***%

  

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	6.4	DSM shall have the right, at any time, to order API, Excipients, and other materials necessary for the manufacture of Products in accordance with the lead-times set forth on
Exhibit 9 hereto. In addition, if due to unanticipated circumstances, any Materials require a longer lead-time, DSM shall be entitled to order such materials as it deems appropriate to fulfill its obligations hereunder.

  

	6.5	Additional Quantities. Should any Purchase Order seek to purchase Products in amounts substantially in excess of amounts set forth in the most recent forecast provided by
Barrier to DSM pursuant to Section 6.1 hereof, or should Barrier desire to increase the amount of Products to be manufactured pursuant to any already submitted Purchase Order, then DSM shall use reasonable commercial efforts to comply with such
requested changes. Notwithstanding the foregoing, DSM shall not be liable to Barrier for any inability, despite its reasonable best efforts, to manufacture such excess Products. 

 ARTICLE 7: PURCHASE OF PRODUCT; DELIVERIES 
  

	7.1	Purchase Orders. Except to the extent the Parties may otherwise agree with respect to a particular shipment, the Product shall be ordered by Barrier pursuant to written
purchase orders, which shall be sent to DSM not less than ninety (90) days prior to the Delivery Dates specified in such purchase orders. Upon receipt of each purchase order by DSM hereunder, DSM shall supply the Product, in such quantities
(with any variances permitted hereunder) and shall use its best efforts to deliver such Product to Barrier no later than seven (7) days of the Delivery Dates specified in such purchase order. Once received by DSM, purchase orders are firm and
may not be cancelled or modified without DSM’s prior written consent, which shall not be unreasonably withheld. 

  

	7.2	Purchase Quantities. All Product shall be ordered in Lot sizes or whole multiples thereof. Each purchase order shall specify the quantity of Units of Product being ordered.
Quantities actually shipped pursuant to a given purchase order may vary from the quantities reflected in such purchase order by up to ten percent (10%) and still be deemed to be in compliance with such purchase order. 

 

	7.3	Delivery Terms. The terms of delivery for the Product shall be F.O.B. DSM’s Greenville, North Carolina plant. Title and risk of loss and/or damage to the Product shall
pass to Barrier upon delivery of the Product to the carrier at DSM’s Greenville, North Carolina plant. All Products shall be properly prepared for safe and lawful shipment by DSM; shall be shipped to Barrier’s distribution center or other
location designated by Barrier, via the common carrier mutually agreed upon by the Parties; and shall be accompanied by appropriate transportation and other agreed upon documentation. No products of any Third Party shall be shipped with the
Products. Shipping cost actually prepaid by DSM will be billed to Barrier monthly by DSM on separate invoices. 

  

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	7.4	Invoicing. DSM shall invoice Barrier upon shipment of finished Product in accordance with Section 8.4 hereinafter. For production qualification lots (“PQ
Lots”), DSM may invoice Barrier for *** of the price for such PQ Lots upon completion of production thereof, irrespective of whether or not Product Approval has been granted by the FDA. 

  

	7.5	Import and Export Matters. Barrier will prepare, obtain, and maintain all necessary import and export registrations relating to the Product and the Active Pharmaceutical
Ingredients. Barrier represents and warrants that it will comply with all applicable import and export laws and regulations. If Barrier elects to export Product for sale and/or marketing within countries outside the Territory, then Barrier shall so
advise DSM; and Barrier shall be responsible for providing all necessary compliance information to DSM so that DSM can achieve compliance with the requirements of such additional countries. Upon achievement of compliance, the definition of
Territory, Section 1.33, shall be amended to reflect the addition of other countries; and any additional costs incurred by DSM for registrations, fees, foreign regulatory compliance, and other related costs shall be for Barrier’s account.

 ARTICLE 8: PRICE; PRICE INCREASES; ADDITIONAL PAYMENTS 
  

	8.1	Price. For all Product which is the subject of purchase orders submitted by Barrier prior to or during the first Contract Year, Barrier shall pay to DSM the Product Price set
forth in Exhibit 1 hereto, subject to adjustment as set forth in Section 8.2 hereof. 

  

	8.2	Price Increases. 

  

	 	8.2.1	Annual Increase. The Product Price may be increased by DSM for each Contract Year following the first Contract Year by (i) a percentage amount equal to the percentage
increase in the Producer Price Index (Pharmaceutical Preparations, ethical PCU 2834 #1, hereinafter referred to as the “PPI”), published by the United States Department of Labor, Bureau of Labor Statistics, or comparable successor index,
during the twelve (12) month period ending with the most recent month for which published monthly statistics are available as of the first day of the new Contract Year. Changes in the Product Price pursuant to this Section 8.2 shall become
effective as of January 1 of each new Contract Year for all scheduled Delivery Dates during such year. 

  

	 	8.2.2	Increased Processing Costs. The Product Price may also be increased by DSM upon written notice to Barrier following startup of production, defined as the first *** commercial
batches manufactured hereunder, relating to increased costs for extended processing times, revised Specifications, or other process requirements which exceed the initial assumptions and parameters. The Parties shall negotiate in good faith to
conclude agreement on Product pricing which fairly reflects such increased costs. 

  

 13 

	 	8.2.3	Compliance with Foreign Regulatory Authorities. Additional payments or price increases may also be required to comply with regulatory requirements, fees, and other expenses
incurred by DSM for importation of Product into foreign countries, in accordance with Section 7.5. 

  

	8.3	Taxes. The Product Price set forth in Exhibit 1 does not include sales, use, consumption, or excise taxes of any taxing authority. The amount of such taxes, if any,
will be added to the Product Price in effect at the time of shipment thereof and shall be reflected in the invoices submitted to Barrier by DSM pursuant to this Agreement. Barrier shall pay the amount of such taxes to DSM in accordance with the
payment provisions of this Agreement. 

  

	8.4	Method of Payment. At the time of each shipment of Product, as deemed acceptable per the Quality Agreement, hereunder, DSM shall invoice Barrier, and Barrier shall pay such
invoices within thirty (30) days of the invoice date. Payments received after the due date shall be subject to interest at the rate of ***. All payments due hereunder to DSM shall be sent to DSM at the times set forth herein by check or wire
transfer to such accounts as DSM may designate to Barrier in writing from time to time in accordance with Section 19.10 hereof. Immediately following the initiation of any wire transfer to DSM, Barrier shall notify DSM’s cash management
department, as DSM may direct from time to time in accordance with Section 19.10. All invoices to Barrier shall be sent to the “Attention: Accounts Payable” at the address first set forth in Section 19.10.

  

	8.5	Audit. Barrier shall have the option, on an annual calendar-year basis, to request an audit of any Product prices or other charges invoiced by DSM during the preceding year.
Such audits shall be performed by an independent certified public accountant, mutually agreeable to Barrier and DSM (the “Independent Auditor”), who shall be permitted to review DSM’s records and accounts relating to this Agreement to
verify that invoices issued hereunder were correctly prepared. The Independent Auditor shall only report to Barrier whether the invoices were correctly calculated; and if not, the amount by which the invoices were over-stated or under-stated.
Barrier shall not otherwise have access to the financial records of DSM. The Independent Auditor shall be subject to the confidentiality provisions set forth in Article 14. Promptly following the report of the Independent Auditor, the Parties shall
resolve any over-charges or under-charges in good faith. 

 ARTICLE 9: RECALLS 
  

	9.1	 Product recalls and FDA contacts relating to recall of Product shall be the responsibility of, and under the control of, Barrier. However, in the event that either
Party has reason to believe that any Products should be recalled or withdrawn from distribution, such Party shall promptly inform the other in writing 

  

 14 

	 	 
prior to taking any such action. Barrier shall notify the FDA, DEA, and any foreign regulatory agencies of any recall, and shall be responsible for
coordinating all necessary activities regarding the action taken. DSM and Barrier acknowledge that each Party has significant regulatory obligations; and accordingly agree that each Party shall fully cooperate with the other to complete the recall,
and shall thereafter resolve any allocation of liability as may be appropriate in accordance with the terms of this Agreement. 

  

	9.2	If any Product is recalled as a result of the supply by DSM of Product that does not conform to the Specifications or other Product requirements of this Agreement, then subject to
Section 5.4, DSM shall reimburse Barrier for its reasonable expenses actually incurred as a result of such recall. If Barrier elects to utilize a Third Party to conduct a recall, Barrier shall so notify DSM and shall await DSM’s consent,
which consent shall not unreasonably be withheld. 

  

	9.3	If each Party contributes to the cause for a recall, the expenses actually incurred as a result of such recall will be shared in proportion to each Party’s responsibility. All
other recalls of Product shall be at Barrier’s sole expense. Barrier shall give DSM prompt written notice of any Product recalls that Barrier believes were caused or may have been caused by DSM’ failure to comply with this Agreement or the
Specifications. 

  

	9.4	Barrier shall maintain records of all sales of Commercial Product and customers sufficient to adequately administer a recall, market withdrawal or correction for a period of five
(5) years after termination or expiration of this Agreement. Subject to Section 9.1, Barrier shall in all events be responsible for conducting any recalls, market withdrawals or corrections with respect to the Product.

 ARTICLE 10: VALIDATION; REGULATORY 
  

	10.1	Validation. 

  

	 	10.1.1	DSM shall prepare equipment qualification and manufacturing validation procedures, and shall perform qualification of equipment and utilities as well as validation of the
manufacturing, packaging and cleaning processes in accordance with such procedures. 

  

	 	10.1.2	The Parties recognize that the Validation Lots are being manufactured in part to validate their manufacturability and conformity to the Specifications. Therefore, any part of the
Validation Lots which the Parties determine does not meet the Specifications shall not be subject to the warranty contained in Section 5.1 hereof or to the claims procedures set forth in Section 12.1 hereof; and, unless the failure of such
nonconforming Validation Lot is due to the negligence or fault of DSM, Barrier shall pay DSM the full Product Price for such nonconforming Validation Lots as set forth in Section 8.1 hereof. Barrier shall not pay DSM for Validation Lots which
fail to meet the Specifications due to the fault or negligence of DSM. 

  

 15 

	10.2	Regulatory. 

  

	 	10.2.1	DSM will provide Barrier with standard regulatory support as identified under the heading “Regulatory Support” in Exhibit 7 attached hereto. In addition, DSM shall
provide Barrier with regulatory consulting services as identified under the heading “Regulatory Consulting” in Exhibit 7 attached hereto. Regulatory support services, as identified in Exhibit 7, shall be at no additional
charge to Barrier; regulatory consulting services shall be billed at DSM’s standard hourly rates and payable pursuant to Section 8.4 of this Agreement. Additional regulatory services and/or documentation may be provided by DSM, subject to
the agreement of the Parties and subject to additional charges. 

  

	 	10.2.2	Barrier shall provide DSM with all documents reasonably requested by DSM relating to the FDA’s pre-approval inspection of DSM’s manufacturing facility, including, but not
limited to, development reports, CMC sections of Barrier’s NDA or other Regulatory Documentation and stability data. In addition, Barrier shall provide to DSM a copy of Barrier’s annual report with respect to the manufacture and control of
the Product; and Barrier shall take into consideration any DSM comments to such annual report with respect to the Product. DSM shall provide comments on the Annual Report to Barrier within 3 days after receipt. Notwithstanding the foregoing or
anything in this Agreement to the contrary, Barrier shall be solely responsible for the CMC regulatory strategy. 

  

	10.3	Analytical and Validation Methodology. Any analytical and validation methodology supplied by Barrier and required for use by DSM in the production of Product hereunder
(i) must be certified by Barrier to be appropriate for the intended use (e.g., cleaning verification, product release, in-process testing, and stability testing), (ii) must be validated per current regulatory guidelines, and
(iii) must be readily available to DSM personnel during any regulatory inspection in the DSM site. Periodic recertification of methods validations may be required in accordance with CGMP. Required analytical and validation methodology which is
not supplied by Barrier, or not previously developed by DSM for Barrier, will be developed by DSM at Barrier’s expense according to DSM’s standard rates. 

  

	10.4	Reference Standards. Reference standards required for API and key components of the Product which are readily available through the U. S. Pharmacopaeia shall be provided by
DSM. If such reference standards are not readily available or must be made to order, they shall be obtained at Barrier’s expense, including any re-certifications thereof. 

  

 16 

	10.5	Stability Studies. DSM shall provide stability studies once per year, per SKU, at no additional cost to Barrier. Additional stability studies shall be available to Barrier at
DSM’s standard rates. 

 ARTICLE 11: TERM; TERMINATION 
  

	11.1	Term. Unless sooner terminated pursuant to the terms hereof, the term of this Agreement shall commence on the Effective Date and shall continue in force and effect until
December 31, 2009. 

  

	11.2	Termination by Mutual Agreement. This Agreement may be terminated at any time upon mutual written agreement between the Parties. 

  

	11.3	Termination for Default. This Agreement may be terminated by either Party in the event of the material breach or default by the other Party of the terms and conditions
hereof; provided, however, the other Party shall first give to the defaulting Party written notice of the proposed termination or cancellation of this Agreement, specifying the grounds therefor. Upon receipt of such notice, the defaulting
Party shall have thirty (30) days to respond by curing such default (or ten (10) business days with respect to a failure by Barrier to pay any amounts hereunder when due); or (other than with respect to Barrier’s failure to pay any
amounts hereunder when due) by delivering to the other Party a certificate that such breach is not capable of being cured within such thirty (30) days and that the breaching Party is working diligently to cure such breach; but in no event shall
the time period for curing such breach exceed an additional thirty (30) days. If the breaching Party does not so respond or fails so to work diligently and to cure such breach within the additional time set forth above, then the other Party may
either suspend the Agreement indefinitely or terminate the Agreement. Termination of this Agreement pursuant to this Section 11.3 shall not affect any other rights or remedies which may be available to the non-defaulting Party.

  

	11.4	Bankruptcy; Insolvency. Either Party may terminate this Agreement upon the occurrence of either of the following: 

  

	 	11.4.1	The entry of a decree or order for relief by a court having jurisdiction in respect of the other Party in an involuntary case under the Federal Bankruptcy Code, as now constituted
or hereafter amended, or under any other applicable federal or state insolvency or other similar law and the continuance of any such decree or order unstayed and in effect for a period of sixty (60) consecutive days; or

  

	 	11.4.2	The filing by the other Party of a petition for relief under the Federal Bankruptcy Code, as now constituted or hereafter amended, or any other applicable federal or state
insolvency or other similar law. 

  

	11.5	 Expiration; Termination; Consequences. Upon expiration or termination of this Agreement, whichever is sooner (but in the case of termination, only if
directed by the terminating Party in the notice of termination), DSM shall manufacture and 

  

 17 

	 	 
ship, and Barrier shall purchase in accordance with the provisions hereof, any and all amounts of Product ordered by Barrier hereunder prior to the date on
which such notice is given; and DSM shall return to Barrier all unused Active Pharmaceutical Ingredients in DSM’s possession which have been provided by Barrier hereunder. In addition, upon expiration or termination of this Agreement, whichever
is sooner, at Barrier’s option, (i) the Parties shall promptly agree on a procedure which allows Barrier to possess any equipment located at DSM’s facility that is owned by Barrier (with Barrier paying all reasonable costs to access
and remove such equipment, including DSM’s facility restoration costs), or (ii) DSM shall purchase such equipment from Barrier by paying Barrier the depreciated (calculated on a straight-line basis) book value thereof.

  

	 	11.5.1	In addition, upon expiration or termination of this Agreement, at DSM’s option, Barrier shall purchase from DSM (i) at DSM’s Acquisition Cost, all Active
Pharmaceutical Ingredients, Excipients and other materials acquired by DSM hereunder, (ii) all work-in-progress for the Product at *** and (iii) all other finished Product then in DSM’s possession; and (iv) Barrier shall
compensate DSM for all other uncancellable commitments made by DSM to satisfy existing purchase orders. Notwithstanding the foregoing, if any cancellation penalty amount is less than an actual expense for such commitment (including restocking fees
for returnable materials), Barrier shall be required to reimburse DSM solely for the amount of the cancellation penalty rather than for the applicable expense. 

  

	 	11.5.2	Upon expiration or termination of this Agreement, the obligations of: (i) confidentiality; (ii) restrictions on use of Confidential Information;
(iii) indemnification; and (iv) warranties and obligations with respect to product quality set forth in this Agreement and the Quality Agreement shall survive such expiration or termination. 

 ARTICLE 12: CLAIMS 
  

	 	12.1	Claims. 

  

	 	12.1.1	In the event that any of the Product delivered to Barrier’s designated carrier by DSM shall, upon visual inspection, fail to conform with any warranty set forth herein, Barrier
shall reject such Product by giving written notice to DSM within thirty (30) days after Barrier’s receipt of such Product and all associated quality assurance documents, including, without limitation, the certificate of analysis. Barrier
shall give notice of any defect not discovered during the incoming visual inspection promptly after its discovery. 

  

	 	12.1.2	For any claim relating to the container or container closure system for Products packaged by DSM, Barrier shall make the subject packaging available to DSM for analysis.

  

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	 	12.1.3	Any notice given hereunder shall specify the manner in which the Product fails to meet such warranty or the Specifications. If it is determined by agreement of the Parties (or in
the absence of agreement of the Parties, by a mutually acceptable independent laboratory or consultant whose fees shall be paid by the non-prevailing Party), that the nonconformity is due to damage to the Product caused by Barrier or its agents,
then DSM shall have no liability to Barrier with respect thereto. If the nonconformity is otherwise caused by DSM’s breach of this Agreement, negligence or willful misconduct, then DSM shall credit Barrier’s account for the price invoiced
for such nonconforming Product. 

  

	 	12.1.4	If payment therefore has previously been made by Barrier, DSM shall, at Barrier’s option, (x) apply such credit against future orders; (y) offset the amount thereof
against other amounts then due DSM hereunder; or (z) replace such nonconforming Product with conforming Product at no additional cost to Barrier. 

  

	 	12.1.5	CLAIMS ARISING HEREUNDER SHALL BE DEEMED TO HAVE BEEN WAIVED BY BARRIER IF NOT BROUGHT WITHIN SIX (6) MONTHS FOLLOWING THE DATE OF THE OCCURRENCE GIVING RISE TO THE CLAIM,
EXCEPT FOR CLAIMS RELATING TO LATENT PRODUCT DEFECTS WHICH COULD NOT REASONABLY HAVE BEEN DISCOVERED. SUCH LATENT DEFECT CLAIMS SHALL BE DEEMED WAIVED BY BARRIER IF NOT BROUGHT WITHIN THREE (3) MONTHS FOLLOWING DISCOVERY OF THE DEFECT, BUT IN
NO CASE LATER THAN THREE (3) MONTHS FOLLOWING THE EXPIRATION DATE OF SUCH PRODUCT. 

  

	12.2	Disposition of Nonconforming Product. In any case where Barrier expects to make a claim against DSM with respect to damaged or otherwise nonconforming Product, Barrier shall
not dispose of such Product without written authorization and instructions of DSM either to dispose of the Product or to return the Product to DSM. 

  

	12.3	Product Holds/Rejects. DSM will notify Barrier per the Quality Agreement of Product holds and/or rejects that may have an impact on the manufacturing process and that may
require Barrier approval prior to resolution. 

 ARTICLE 13: INDEMNIFICATION OF THIRD PARTY CLAIMS 
  

	13.1	 Indemnification by Barrier. Barrier shall indemnify, defend and hold DSM, its Affiliates and their respective directors, officers, employees, agents,
successors and assigns, harmless from and against any damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) arising out of or in connection with (a) any
Third Party claim of illness, injury, or death caused by the use of any Product manufactured by DSM 

  

 19 

	 	 
hereunder in accordance with the Specifications; or (b) any proceeding instituted by or on behalf of a Third Party based upon a claim that the
manufacture, use or sale of the Product infringes a United States patent or any other proprietary rights claimed by Barrier and utilized by DSM in the production of the Product; or (c) any claim of illness, injury, or death arising out of
Barrier’s failure to inform DSM of health risks pursuant to Section 2.4 above; or (d) any act or omission of negligence, gross negligence or willful misconduct by Barrier or its respective directors, officers, employees, agents, or
representatives. 

  

	 	13.2	Indemnification by DSM. DSM shall indemnify, defend and hold Barrier, its Affiliates and their respective directors, officers, employees, agents, successors and assigns
harmless from and against any damages, judgments, claims, suits, actions, liabilities, costs and expenses (including, but not limited to, reasonable attorneys’ fees) arising out of or in connection with any Third Party claim of illness, injury
or death caused by the use of any Product manufactured by DSM hereunder which does not conform to the Specifications; or (b) any proceeding instituted by or on behalf of a Third Party based upon a claim that the manufacture of the Product
infringes a United States patent or any other proprietary rights (except for such claims as are subject to indemnity by Barrier pursuant to Section 13.1, above) or (c) any act or omission of negligence, gross negligence or willful
misconduct by DSM or its respective directors, officers, employees, agents, or representatives. 

  

	 	13.3	Indemnification Procedures. A Party (the “Indemnitee”) which intends to claim indemnification under this Article 13 shall promptly notify the other Party
(the “Indemnitor”) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its Affiliates, or any of their respective directors, officers, employees or agents intend to claim such
indemnification; provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is prejudiced by such
failure. The Indemnitee, its Affiliates, and their respective directors, officers, employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation, negotiation, compromise, settlement and defense of
any action, claim or other matter covered by this indemnification. The Indemnitor shall be in charge of and control of any such investigation, negotiation, compromise, settlement and defense, and shall have the right to select counsel with respect
thereto, provided that the Indemnitor shall promptly notify the Indemnitee of all material developments in the matter. In no event shall the Indemnitee compromise or settle any such matter without the prior written consent of the other Party,
which consent shall not be unreasonably withheld or delayed; nor shall the non-consenting Party be bound by any such settlement. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and at
its own expense. 

  

	 	13.4	Survival of Indemnification Obligations. The provisions of this Article 13 shall survive the expiration or termination of this Agreement. 

  

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 ARTICLE 14: CONFIDENTIALITY 
  

	14.1	During the term of this Agreement and for a period of seven (7) years following termination of this Agreement, each of Barrier and DSM agrees not to publish, disclose or use
for any purpose other than its performance hereunder, any information disclosed by the other Party which is DSM Intellectual Property or Barrier Intellectual Property, respectively, or which is designated as proprietary or confidential
(“Confidential Information”), including, without limitation, information stored on audio or video tapes and disks, or information or knowledge visually acquired by or generated by Barrier or DSM personnel in the form of written notes and
memoranda memorializing information or knowledge acquired visually, aurally or orally in the course of either Party’s performance hereunder. 

  

	14.2	Each Party shall limit disclosure of Confidential Information received hereunder to only those of its (or its Affiliates’) officers and employees who are directly concerned
with the performance of this Agreement. Each Party shall advise such officers or employees upon disclosure of any Confidential Information to them of the confidential nature of the Confidential Information and the terms and conditions of this
Article 14, and shall use all reasonable safeguards to prevent unauthorized disclosure of the Confidential Information by such officers and employees. 

  

	14.3	Both Parties agree that the following shall not be considered Confidential Information subject to this Agreement: 

  

	 	14.3.1	information that is in the public domain by publication or otherwise, provided that such publication is not in violation of this Agreement or any other confidentiality agreement;

  

	 	14.3.2	information that the Receiving Party can establish in writing was in the Receiving Party’s possession prior to the time of disclosure by the Disclosing Party and was not
acquired, directly or indirectly, from the Disclosing Party; 

  

	 	14.3.3	information that the Receiving Party lawfully receives from a Third Party; provided, however, that such Third Party was not obligated to hold such information in confidence;

  

	 	14.3.4	information that, prior to the Disclosing Party’s disclosure thereof, was independently developed by the Receiving Party without reference to any Confidential Information as
established by appropriate documentation; and 

  

	 	14.3.5	 information that the Receiving Party is compelled to disclose by a court, administrative agency, or other tribunal; provided however, that in such case the
Receiving Party shall immediately give as much advance notice as feasible to the Disclosing Party to enable the Disclosing Party to 

  

 21 

	 	 
exercise its legal rights to prevent and/or limit such disclosure. In any event, the Receiving Party shall disclose only that portion of the Confidential
Information that, in the opinion of the Receiving Party’s legal counsel, is legally required to be disclosed and will exercise reasonable best efforts to ensure that any such information so disclosed will be accorded confidential treatment by
said court, administrative agency or tribunal. 

  

	14.4	All Confidential Information shall remain the property of the Disclosing Party. Upon the termination of this Agreement, or at any time upon the request of the other Party, the
Receiving Party shall immediately return or destroy any Confidential Information in the Receiving Party’s possession, custody or control, except that the Receiving Party may keep one (1) copy for archival purposes. The Disclosing
Party’s failure to request the return of Confidential Information shall not relieve the Receiving Party of its confidentiality obligations under this Agreement. 

  

	14.5	Each Party acknowledges and expressly agrees that the remedy at law for any breach by it of the terms of this Article 14 shall be inadequate and that the full amount of damages
which would result from such breach are not readily susceptible to being measured in monetary terms. Accordingly, in the event of a breach or threatened breach by either Party of this Article 14, the other Party shall be entitled to immediate
injunctive relief prohibiting any such breach and requiring the immediate return of all Confidential Information. The remedies set forth in this Section 14.5 shall be in addition to any other remedies available for any such breach or threatened
breach, including the recovery of damages from the breaching Party. 

  

	14.6	The terms and conditions of this Agreement, but not the fact of its existence, shall constitute Confidential Information of Barrier, except that either Party may disclose such terms
and conditions to its corporate affiliates in accordance with Section 14.1 hereof. 

 ARTICLE 15: INTELLECTUAL PROPERTY

  

	15.1	Except as provided in Section 15.3, all DSM Intellectual Property and any Developments thereof during the term of this Agreement shall remain the property of DSM. Barrier shall
have a license to use any DSM Intellectual Property supplied to it solely to the extent necessary to assist Barrier in its performance hereunder. Barrier shall acquire no other right, title or interest in the DSM Intellectual Property as a result of
its performance hereunder. 

  

	15.2	Except as provided in Section 15.3, all Barrier Intellectual Property and any Developments thereof during the term of this Agreement shall remain the property of Barrier. DSM
shall have a license to use any Barrier Intellectual Property supplied to it solely to the extent necessary to assist DSM in its performance hereunder. DSM shall acquire no other right, title or interest in the Barrier Intellectual Property as a
result of its performance hereunder. 

  

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	15.3	Joint Developments by Barrier and DSM of DSM Intellectual Property shall remain the property of DSM, however Barrier shall have a non-exclusive, royalty-free license to use such
Developments, but without the right to sub-license to any third party without the consent of DSM. Likewise, joint Developments by Barrier and DSM of Barrier Intellectual Property shall remain the property of Barrier, however DSM shall have a
non-exclusive, royalty-free license to use such Developments to the extent they are applicable to DSM’s process technology, but without the right to sub-license to any third party without the consent of Barrier. 

  

	15.4	In the event that either Party decides to file one or more patent applications covering any joint Developments, then the non-filing Party shall, at the filing Party’s request
and expense, assist the first Party in the preparation and prosecution of such patent application(s) and shall execute all documents deemed necessary by the filing Party for the filing thereof and/or the vesting in both Parties of joint title
thereto. 

 ARTICLE 16: FORCE MAJEURE 
  

	16.1	Effects of Force Majeure. Neither Party shall be held liable or responsible for failure or delay in fulfilling or performing any of its obligations under this Agreement in
case such failure or delay is due to any condition beyond the reasonable control of the affected Party including, without limitation, Acts of God, strikes or other labor disputes, war, riot, earthquake, tornado, hurricane, fire, civil disorder,
explosion, accident, flood, sabotage, lack of or inability to obtain adequate fuel, power, materials, labor, containers, transportation, supplies or equipment, breakage or failure of machinery or apparatus, national defense requirements, or supplier
strike, lockout or injunction (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure Event continues, provided, however, that Barrier may cancel without penalty any and all Purchase Orders in the event
DSM is unable to fulfill an outstanding Purchase Order within ninety (90) days of its scheduled delivery date due to a Force Majeure Event. Upon cessation of such Force Majeure Event, such Party shall promptly resume performance on all Purchase
Orders which have not been terminated. 

  

	16.2	Notice of Force Majeure Event. In the event either Party is delayed or rendered unable to perform due to a Force Majeure Event, the affected Party shall give notice thereof
and its expected duration to the other Party promptly after the occurrence of the force majeure event; and thereafter, the obligations of the affected Party will be suspended during the continuance of the Force Majeure Event. The affected Party
shall take commercially reasonable steps to remedy the Force Majeure Event with all reasonable dispatch, but such obligation shall not require the settlement of strikes or labor controversies on terms unfavorable to the affected Party.

  

 23 

 ARTICLE 17: LEGAL COMPLIANCE; AUTHORIZATION 
  

	17.1	Legal Compliance. Each Party shall comply in all material respects with all federal and state laws and regulations applicable to the conduct of its business pursuant to this
Agreement, including, but not limited to, the FD&C Act. 

  

	17.2	Authorization. 

  

	 	17.2.1	DSM hereby represents and warrants to Barrier that all corporate action on the part of DSM and its officers and directors necessary for the authorization, execution and delivery of
this Agreement and the performance of all obligations of DSM hereunder has been taken. 

  

	 	17.2.2	Barrier hereby represents and warrants to DSM that all requisite action on the part of Barrier and its officers and directors necessary for the authorization, execution and delivery
of this Agreement and the performance of all obligations of Barrier hereunder has been taken. 

 ARTICLE 18: PRESS RELEASES; USE OF
NAMES 
  

	18.1	Press Releases. Any press release, publicity or other form of public written disclosure related to this Agreement prepared by one Party shall be submitted to the other Party
prior to release for approval, which approval shall not be unreasonably withheld or delayed by such other Party; provided, however, that Barrier and DSM’s parent company may announce the signing of this Agreement in their quarterly
results release without prior approval. This Section 18.1 shall not apply to package inserts, promotional material, or any other disclosure relating to any aspect of Commercial Product other than the manufacturing thereof.

  

	18.2	Use of Names. Except as expressly provided or contemplated hereunder and except as otherwise required by applicable law, no right is granted pursuant to this Agreement to
either Party to use in any manner the trademarks or name of the other Party, or any other trade name, service mark, or trademark owned by or licensed to the other Party in connection with the performance of this Agreement. Notwithstanding the above,
as may be required by applicable law, Barrier, DSM and their Affiliates shall be permitted to use the other Party’s name and to disclose the existence and terms of this Agreement in connection with securities or other public filings.

 ARTICLE 19: MISCELLANEOUS 
  

	19.1	Independent Contractors. The relationship between Barrier and DSM is that of independent contractors and nothing herein shall be deemed to constitute the relationship of
partners, joint venturers, nor of principal and agent between Barrier and DSM. Neither Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other
Party to any contract, agreement or undertaking with any Third Party. 

  

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	19.2	Assistance from Barrier. To assist DSM in its performance of this Agreement, Barrier shall provide DSM, in a timely fashion, with all relevant information, documentation and
data (including without limitation any information, documentation and data relating to product safety and information, documentation and data, including NDA and/or other Regulatory Documentation numbers, NDC codes, etc., necessary for DSM to drug
list the product) which is necessary or appropriate for DSM’s performance hereunder. If requested by DSM to provide support or information, Barrier shall provide such support or information (or an explanation of the legitimate reason for any
delay and a projected date by which such support or information will be provided) within five (5) business days of DSM’s request. In the event Barrier is to review or approve any information, documentation, data or samples prepared or
supplied by or on behalf of DSM, it shall complete such review and approval process within five (5) business days. 

  

	19.3	Assignment; Subcontractors. This Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent
shall not unreasonably be withheld; provided that, subject to Section 3.2 hereinabove, Barrier may assign this Agreement without DSM’s consent to any person or entity that (a) acquires all or substantially all of the stock or
assets of Barrier or (b) acquires, whether by license, divestiture or otherwise, all or substantially all of Barrier’s assets which are the subject matter of this Agreement. Any purported assignment in violation of the preceding sentence
shall be void. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve either Party of responsibility for the performance of any obligation which accrued prior to the effective date of
such assignment. DSM may, with Barrier’s prior written consent, utilize subcontractors to perform any part of this Agreement. 

  

	19.4	Continuing Obligations. Termination, assignment or expiration of this Agreement shall not relieve either Party from full performance of any obligations incurred prior
thereto. 

  

	19.5	Waiver. Neither Party’s waiver of any breach or failure to enforce any of the terms and conditions of this Agreement, at any time, shall in any way affect, limit or
waive such Party’s right thereafter to enforce and compel strict compliance with every term and condition of this Agreement. 

  

	19.6	 Severability. Each Party hereby expressly agrees that it has no intention to violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or community or association of countries; that if any word, sentence, paragraph, clause or combination thereof in this Agreement is found by a court or executive body with
judicial powers having jurisdiction over this Agreement or either Party hereto, in a final unappealed order, to be in violation of any such provisions in 

  

 25 

	 	 
any country or community or association of countries, such words, sentences, paragraphs, clauses or combination shall be inoperative in such country or
community or association of countries and the remainder of this Agreement shall remain binding upon the Parties, so long as enforcement of the remainder does not violate the Parties’ overall intentions in this transaction.

  

	19.7	Headings. The headings in this Agreement are for convenience of reference only and shall not affect its interpretation. 

  

	19.8	Construction. This Agreement has been jointly prepared on the basis of the mutual understanding of the Parties and shall not be construed against either Party by reason of
such Party’s being the drafter hereof or thereof. 

  

	19.9	Exhibits, Schedules and Attachments. Any and all exhibits, schedules and attachments referred to herein form an integral part of this Agreement and are incorporated into this
Agreement by such reference. 

  

	19.10	Notices. All notices and other communications required or permitted to be given under this Agreement shall be in writing and shall be delivered personally or sent by
(a) registered or certified mail, return receipt requested, (b) a nationally-recognized courier service guaranteeing next-day delivery, charges prepaid or (c) facsimile (with the original promptly sent by any of the foregoing
manners), and shall be deemed to have been given upon mailing or upon transmission by facsimile, as the case may be. Any such notices shall be addressed to the receiving Party at such Party’s address set forth below, or at such other address as
may from time to time be furnished by similar notice by either Party: 

  

			
	  If to DSM:	  	DSM Pharmaceuticals, Inc.
		  	5900 NW Greenville Blvd.
		  	Greenville, NC 27834
		  	Attn: Terry Novak, Chief Marketing Officer
		  	Phone No.: (252) 707-7620
		  	Facsimile No.: (252) 707-7046
		
		  	With a copy of legal notices to: Attn: Company Secretary
		
	  If to Barrier:	  	Barrier Therapeutics, Inc.
		  	600 College Road East, Suite 3200
		  	Princeton, NJ 08540
		  	Attn: Charles T. Nomides
		  	Phone: (609) 945-1200
		  	Facsimile No.: (609) 945-1212

  

	19.11	 Counterparts. This Agreement and any amendment or supplement hereto may be executed in any number of counterparts and any Party hereto may execute any such
counterpart, each of which when executed and delivered shall be deemed to 

  

 26 

	 	 
be an original and all of which counterparts taken together shall constitute but one and the same instrument. The execution of this Agreement and any such
amendment or supplement by any Party hereto will not become effective until counterparts hereof have been executed by both Parties hereto. 

  

	19.12	Governing Law; Entire Agreement. The validity, interpretation and performance of this Agreement shall be governed and construed in accordance with the laws of the State of
North Carolina without regard to the conflicts of laws provisions thereof. This document, along with the Quality Agreement constitutes the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement. No
terms, conditions, understanding, or agreement purporting to modify or vary the terms of this Agreement shall be binding unless hereafter made in writing and signed by the Party to be bound. No modification to this Agreement shall be effected by the
acknowledgment or acceptance of any purchase order or shipping instruction forms or similar documents containing terms or conditions at variance with or in addition to those set forth herein. 

  

	19.13	Exhibits. The following Exhibits are attached hereto and incorporated herein by reference: 

 Exhibit 1: Product Price and Contract Quantities 
 Exhibit 2: Capital Equipment 
 Exhibit 3: Active Ingredient and Excipient Specifications 
 Exhibit 4: Packaging
Specifications 
 Exhibit 5: Product Specifications 
 Exhibit 6: Quality Agreement 
 Exhibit 7: Pricing for Development Activities and Clinical Trials Exhibit 8: Material Lead Times 
 [Signatures on following
page] 
  

 27 

 IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized
representatives as of the day and year first above written. 
  

					
	 BARRIER THERAPEUTICS, INC.

			
	 By:
	 	 /s/ A. Altomari
	 	
	 Name:
	 	A. Altomari	 	
	 Title:
	 	Chief Commercial Officer	 	
	
	 DSM PHARMACEUTICALS, INC.

			
	 By:
	 	 /s/ Terence S. Novak
	 	
	 Name:
	 	Terence S. Novak	 	
	 Title:
	 	Chief Marketing Officer	 	

  

 28 

 EXHIBIT 1: PRODUCT PRICE &*** 
 Commercial Pricing: 
  

																
	 Zimycan 30gm Tube Full Batch ***
	  	2005	  	2006	  	2007	  	2008	  	2009
	 ***
	  	 	***	  	 	***	  	 	***	  	 	***	  	 	***
	 Product Price
	  	$	***	  	$	***	  	$	***	  	$	***	  	$	***

  

											
	 Zimycan 45gm Tube Full Batch ***
	  	2005	  	2006	  	2007	  	2008	  	2009
	 ***
	  	***	  	***	  		  		  	
	 Product Price
	  	***	  	***	  		  		  	

 Sample Pricing: 
  

												
	 Zimycan 5gm Tube
	  	2005	  	2006	  	2007	  	2008	  	2009
	 ***
	  		  	 	***	  		  		  	
	 Product Price
	  		  	$	***	  		  		  	

  

											
	 Zimycan 30gm Tube Sample Tube Full Batch ***
	  	2005	  	2006	  	2007	  	2008	  	2009
	 ***
	  	***	  		  		  		  	
	 Product Price
	  	***	  		  		  		  	

 Assumptions: 
  

	1.	Commercial volumes will be manufactured, packaged and tested in campaigns of no less than *** per year. 

  

	2.	Commercial Pricing and Sample pricing to be confirmed upon finalization of release testing methodology and associated resources. 

  

	3.	Commercial volumes and prices are full batch quantities and are for US distribution. 

  

	4.	Commercial and Sample Pricing is based upon packaging configuration below. 

  

	5.	Pricing does not include the 45 Gram Tube or the 30 Gram Sample Tube. 

  

	6.	Additional placebo batches for release testing will be priced as needed. 

  

					
	 30 Gram Tube
	  	
	 Component
	    	 Dimensions
	  	 
	 Tube (Aluminum)
	    	130 (H) x 22 (D)	  	
	 Carton (4 Panels)
	    	37.00 (L) x 36.00 (W) x 145.00 (H)	  	
	 Insert (Roll Feed)
	    	7 1/2 (L) x 12 1/8 (W) (max size)	  	
	 Shipper
	    	72 per Shipper Bundled by 12	  	

  

					
	 5 Gram
	  	
	 Component
	    	 Dimensions
	  	 
	 Tube (Aluminum)
	    	93 mm (H) x 13.5 mm (D)	  	

 EXHIBIT 2: CAPITAL / EQUIPMENT 
 No capital equipment is being purchased by Barrier for this project. 

 EXHIBIT 3: ACTIVE INGREDIENT AND EXCIPIENT SPECIFICATIONS 
 (See attached specifications) 

 EXHIBIT 4: PACKAGING SPECIFICATIONS 
 (See attached specifications) 

 EXHIBIT 5: PRODUCT SPECIFICATIONS 
 (See attached specifications) 

 EXHIBIT 6: QUALITY AGREEMENT 
 (See attached agreement) 

 QUALITY AGREEMENT 
 BY AND BETWEEN 
 Barrier Therapeutics, Inc.

 600 College Road East 
 Princeton, NJ 08540-6697 
 (hereafter called “Barrier”) 
  

			
	 Approved by:

	 Barrier Therapeutics, Inc.

		
	 By:
	 	 Irene Wei

	 Name/Title: Irene Wei, PhD, MBA

	 Head, Quality Assurance/Quality Control

		
	 Date:
	 	 8/6/04

 And 
 DSM Pharmaceuticals, Inc. 
 5900 NW Greenville Blvd. 
 Greenville, North Carolina 27834 
 (hereafter
called “DSM”) 
  

			
	 Approved by:

	 DSM Pharmaceuticals, Inc.

		
	 By:
	 	 Warren A. Horton

	 Warren A. Horton

	 Vice President Quality Assurance

		
	 Date:
	 	 7/21/04

 The Products Listed in Appendix I (hereafter called the “Product” or “Products”) are
subject to the following conditions: 

 TABLE OF CONTENTS 
  

					
	1.	 	QUALITY AGREEMENT	  	1
			
		 	 1.1    Purpose
	  	1
			
		 	 1.2    Relationship to Supply Agreement
	  	1
			
	2.	 	PRODUCTS	  	1
			
	3.	 	ADMINISTRATIVE INFORMATION	  	1
			
		 	 3.1    Barrier Contact Names
	  	1
			
		 	 3.2    DSM Contact Names
	  	1
			
	4.	 	TERM OF AGREEMENT	  	1
			
	5.	 	MANUFACTURING GMP COMPLIANCE	  	2
			
		 	 5.1    General
	  	2
			
		 	 5.2    Premises
	  	2
			
		 	 5.3    GMP Guidelines
	  	2
			
		 	 5.4    Materials
	  	2
			
		 	 5.5    Materials procured by DSM
	  	3
			
		 	 5.6    Materials Supplied by Barrier for DSM
	  	3
			
		 	 5.7    Master Production Records
	  	3
			
		 	 5.8    Standard Operating Procedures
	  	3
			
		 	 5.9    Methods Validation Certification
	  	4
			
		 	 5.10 Lot Numbers
	  	4
			
		 	 5.11 Dates of Manufacture and Expiration
	  	4
			
		 	 5.12 Manufacturing and Equipment Data
	  	4
			
		 	 5.13 Storage and Shipment
	  	5
			
	6.	 	QUALITY CONTROL	  	5
			
		 	 6.1    General
	  	5
			
		 	 6.2    In-Process and Finished Product Testing
	  	5
			
		 	 6.3    Retain Samples
	  	6
			
		 	 6.4    Routine Stability Program
	  	6
			
		 	 6.5    Out-of-Specification (OOS) Investigations
	  	7
			
	7.	 	QUALITY ASSURANCE	  	7
			
		 	 7.1    Deviations and Investigations
	  	7
			
		 	 7.2    Lot Disposition
	  	7

  

 -i- 

					
		 	 7.3    Quality Assurance Certificate of Compliance/Analysis
	  	7
			
		 	 7.4    Product Release
	  	8
			
		 	 7.5    Product Complaints and Recalls
	  	8
			
		 	 7.6    Records Retention
	  	9
			
		 	 7.7    Quality Assurance Presence in the Manufacturing Facility
	  	9
			
	8.	 	REGULATORY COMPLIANCE	  	9
			
		 	 8.1    Regulatory Inspections
	  	9
			
		 	 8.2    Regulatory Actions
	  	10
			
		 	 8.3    Regulatory Affairs
	  	10
			
		 	 8.4    Right to Audit
	  	11
			
		 	 8.5    Audit Closeout
	  	11
			
		 	 8.6    GMP Documentation
	  	11
			
	9.	 	DISPUTE RESOLUTION	  	11
			
	10.	 	CHANGE MANAGEMENT	  	12
			
		 	 10.1 Technical & cGMP Impact Assessment
	  	12
			
	11.	 	PRODUCT AND PROCESS VALIDATION	  	12
			
		 	 11.1 Process Validation
	  	12
			
		 	 11.2 Cleaning Validation
	  	12
			
		 	 11.3 Equipment, Computer, Facility, and Utilities Qualification
	  	13
			
		 	 11.4 Laboratory Qualification
	  	13
			
	12.	 	ANNUAL PRODUCT REVIEW, ANNUAL REPORT AND DRUG LISTING	  	13
			
		 	 12.1 Annual Product Review
	  	13
			
		 	 12.2 Annual Report
	  	13
			
		 	 12.3 Drug Listing
	  	13

  

 -ii- 

 QUALITY AGREEMENT 
 By and Between DSM Pharmaceuticals, Inc. 
 And Barrier Corporation 
 ARTICLE 1: QUALITY AGREEMENT 
  

	1.1	Purpose 

  

	 	1.1.1	This agreement (this “Agreement”) defines the roles and responsibilities for DSM when providing services and/or Products for Barrier. 

  

	 	1.1.2	This Agreement also defines how the quality departments of DSM and Barrier will interact with each other. 

  

	1.2	Relationship to Supply Agreement 

  

	 	1.2.1	This Agreement shall be incorporated within and constitute a part of the supply agreement by and between DSM and Barrier (the “Supply Agreement”).

  

	 	1.2.2	In the event of a conflict between any of the provisions of this Quality Agreement and the Supply Agreement, the provisions of the Supply Agreement shall govern.

 ARTICLE 2: PRODUCTS 
 The Products to be manufactured for Barrier by DSM are described in Appendix I. 
 ARTICLE 3: ADMINISTRATIVE INFORMATION

  

	3.1	Barrier Contact Names 

 See Appendix II. 

 

	3.2	DSM Contact Names 

 See Appendix II. 
 Contact names may be updated as required upon written notice by either party to the other. 
 ARTICLE 4: TERM OF AGREEMENT. 
 This Quality Agreement shall continue in force for the term of
the Supply Agreement with respect to Product supplied thereunder. This Quality Agreement may be modified as agreed in writing by both parties. 

 ARTICLE 5: MANUFACTURING GMP COMPLIANCE 
  

	5.1	General 

 The manufacturing operations for the Products to
be performed by DSM are defined in the Supply Agreement; and responsibilities are outlined in Appendix IV of this Quality Agreement. 
  

	5.2	Premises 

  

	 	5.2.1	DSM will perform required operations for manufacturing activities at its Greenville, North Carolina site. 

  

	 	5.2.2	The premises and equipment used to manufacture the Products will be maintained according to current regulatory requirements and in accordance with the controlled documentation
approved by Barrier. 

  

	 	5.2.3	The manufacture of the Products will be conducted in a suitably controlled environment and such facilities will be regularly monitored for parameters critical to the process to
demonstrate compliance with (i) applicable GMP guidelines and (ii) any conditions registered in the manufacturing authorization (NDA or ANDA or investigational application). 

  

	 	5.2.4	DSM will maintain controlled access to the premises. All visitors shall comply with DSM’s current security and safety requirements, including requirements that visitors sign in
and be escorted during any visit to the areas of the premises used to manufacture, test, and store the Products. 

  

	5.3	GMP Guidelines 

 The principles detailed in the US, EU and
ICH Current Good Manufacturing Practices (including 21 CFR 210 and 211) that govern the standards of manufacture for any product intended for human use, as well as the product cGMP Guidelines, will govern (i) the standards of manufacture of the
Products, (ii) the Product specifications, (iii) any applicable product license, and (iv) the NDA/ANDA application, pharmacopoeia or formulatory requirements. 
  

	5.4	Materials 

  

	 	5.4.1	DSM will use only chemical materials, packaging, and labeling components approved by Barrier and tested in accordance with the documentation reviewed and approved by Barrier.

  

	 	5.4.2	Prior to DSM’s disposition of Product for release by Barrier, all materials used in the Products shall meet DSM’s requirements for production use.

  

 Page 2 

	5.5	Materials procured by DSM 

  

	 	5.5.1	DSM will assure compliance of vendors chosen by DSM and will provide a Certificate of Compliance upon request. For vendors designated by Barrier and which are not DSM-approved
vendors, Barrier shall be responsible for qualifying such vendors of materials used in the Products; and Barrier will provide DSM with a Certificate of Conformance statement for such vendors when requested. DSM shall maintain a quality review
program for materials vendors/suppliers according to defined policies; and documentation developed in the vendor review program shall be available for review by Barrier upon request. 

  

	 	5.5.2	DSM is responsible for ensuring that all material and components procured by DSM for use in the Product are in full compliance with the specifications listed in documentation
reviewed and approved by Barrier. Raw Materials are given a repeat test date upon the satisfactory completion of all initial testing. Repeat testing will be performed at defined time intervals to ensure the chemical, microbiological, and physical
stability of the raw materials unless Barrier provides an official expiration date. Excipient testing may be conducted by an approved third-party contract testing laboratory. 

  

	 	5.5.3	DSM is responsible for ensuring that all materials are stored properly, used correctly, appropriately tested upon receipt, and traceable to the relevant Certificate of Analysis for
the materials. 

  

	5.6	Materials Supplied by Barrier for DSM 

 Barrier is
responsible for ensuring that all materials and components supplied by Barrier for use in the Products are in full compliance with the specifications registered. Barrier will provide DSM a Certificate of Compliance statement for the vendors that
Barrier is responsible for qualifying, and a Certificate of Analysis for materials supplied by Barrier. 
  

	5.7	Master Production Records 

 DSM may transcribe the
manufacturing information (i.e., formulation, filling work order, packaging work order, etc.) into its own format and shall obtain written approval from Barrier for each document version before manufacturing. Mutually agreed changes to documentation
will be handled as outlined by Change Management (see Section 10) of this agreement. 
  

	5.8	Standard Operating Procedures 

 DSM is responsible for
maintaining any SOPs required to manufacture, test, store, disposition for release, and/or release the Products at DSM in accordance with applicable GMP guidelines. 
  

 Page 3 

	5.9	Methods Validation Certification 

  

	 	5.9.1	For those analytical methods to be provided by Barrier, Barrier shall be responsible for providing to DSM approved copies of the current and complete regulatory filed analytical
methods relating to the Products, for application by DSM in the production process, including receipt of API and raw materials, in-process product testing, product lot release, drug and product stability, and cleaning validation.

  

	 	5.9.2	For the analytical methods to be provided by Barrier as forth in Section 5.9.1, Barrier shall provide to DSM a Certification of Methods Validation Compliance stating that
“The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines, and are readily available in case of a regulatory inspection.” 

  

	 	5.9.3	Any new analytical methods that are to be validated by DSM must be reviewed and approved by Barrier prior to implementation. 

  

	5.10	Lot Numbers 

 Batch numbers assigned for each batch of finished pharmaceutical product manufactured by DSM shall be comprised of six (6) randomly assigned alpha-numeric characters, with an optional seventh (7th) alpha character added as a suffix. The first character of the batch number shall always be an alpha character. 
  

	5.11	Dates of Manufacture and Expiration 

 The product
certificate of compliance (the “COC”) for each batch shall utilize a month/year format of MM/YY. The date of expiration on the formal packaging work order batch record shall utilize the format of MM/YYYY. DSM will determine the actual date
of manufacture (the “DOM”) for each batch. The date of expiry shall be the last day of the month of the period of expiry, as computed from the DOM, minus one calendar month. 
 EXAMPLE: If product is manufactured on any day during February, 2004 with a one-year expiry, the date of expiration would be assigned as January 31,
2005. The date of expiration on the formal packaging work order batch record will utilized the format of MM/YYYY, in this example printed as 01/2005. The expiration date to appear on the Certificate of Compliance will have the format of the batch
master (MM/YY) which in this example would be 01/05. 
  

	5.12	Manufacturing and Equipment Data 

 DSM is responsible for
keeping records of equipment usage (including previous Product produced in non-dedicated equipment), cleaning, and any maintenance/calibration performed. 
  

 Page 4 

	5.13	Storage and Shipment 

  

	 	5.13.1	Storage: DSM will store the Products under conditions specified by product label requirements as supplied by Barrier. DSM will ensure that during storage before shipping of
the Products, appropriate controls are in place to insure that there is no interference, theft, product contamination, or mixture with any other products or materials. Barrier will provide details of any labeling requirements, container sealing and
integrity, and storage and shipping conditions for the Products. 

  

	 	5.13.2	Packaging and Labeling for Transit: The Products will be labeled and packaged for transit pursuant to instructions timely provided to DSM in writing by Barrier and complying
with cGMP and other applicable regulations (e.g., OSHA, DEA, DOT). 

  

	 	5.13.3	Segregation of Products: DSM will maintain proper segregation of the Products according to established DSM systems which may be reviewed by Barrier. Different lots of a
single product or different types of products will not be mixed on a single pallet. 

  

	 	5.13.4	Shipment of Product to Barrier: Only approved, finished, labeled Products (unless unapproved or intermediate product is required by Barrier as set forth in Section 7.4.2
or 7.4.3), will be shipped by DSM to Barrier. DSM will not ship any product that is under quarantine unless according to strictly controlled procedures, as agreed between DSM and Barrier, which comply with all applicable regulatory requirements.

 ARTICLE 6: QUALITY CONTROL 
  

	6.1	General 

 The testing activities for the materials and
Products are to be performed by DSM according to the requirements of the Supply Agreement. Following DSM’s dispositioning for release of DSM approved Products to Barrier, the Barrier Quality Control Unit shall be responsible for approving or
rejecting drug products manufactured, processed, or packed by DSM. 
  

	6.2	In-Process and Finished Product Testing 

  

	 	6.2.1	A method transfer of any test method developed by Barrier will be completed prior to DSM’s dispositioning of Products, utilizing the transferred method(s), for release by
Barrier. Barrier will work collaboratively with DSM to transfer any methods required by DSM. 

  

	 	6.2.2	Barrier is responsible for supplying required reference standards that are not available from the Compendia. Such reference standards must be accompanied by a Certificate of
Analysis listing the expiration date and any correction factors that need to be applied. Compendial reference standards are to be procured by DSM. 

  

 Page 5 

	 	6.2.3	Barrier may perform testing to confirm the DSM data. Barrier may perform confirmatory testing during the initial term of this Agreement to validate the DSM data. Periodically
thereafter, Barrier may test material to confirm the DSM data. Dispute resolutions in conflicting test data will be handled according to the provisions of Section 9. 

  

	 	6.2.4	In the event that Barrier completes any release testing required for the Products, Barrier will supply DSM with a Certificate of Analysis and any release testing data and test
specifications from approved suppliers required for release by DSM. DSM shall evaluate all testing data supplied by Barrier in order to assign final disposition of Product. For any testing which Barrier completes, the results shall be made available
to DSM in a timely manner so as not to delay release procedures. 

  

	6.3	Retain Samples 

  

	 	6.3.1	DSM will retain samples of the active ingredients for one (1) year beyond the expiration date of the last product manufactured with that lot of active ingredient. DSM will
retain samples of excipients for a minimum of two (2) years beyond the Date of Manufacture. The amount of sample retained will be at least twice the quantity required to carry out all of the tests required to determine if the material meets its
specifications, with the exception of sterility and pyrogen testing (CFR 211.170a). 

  

	 	6.3.2	Products. DSM will retain samples of the Products for one (1) year beyond the expiry period. The amount of sample retained will be at least twice the quantity required
to carry out all of the tests required to determine if the material meets its specifications, with the exception of sterility and pyrogen testing. (CFR 211.170b) 

  

	6.4	Routine Stability Program 

  

	 	6.4.1	DSM is responsible for maintaining a routine stability testing program for the Products and will provide a stability report to Barrier annually. The stability program will be in
compliance with regulatory commitments as notified by Barrier. Following initial commercial introduction, which requires three (3) lots to be placed on stability testing, at least one (1) lot of each product, of each strength, and in each
package type (largest and smallest) will be placed on stability each year. The stability program will generally follow ICH guidelines. The stability protocol and/or any subsequent changes must be approved by Barrier. 

  

	 	6.4.2	Stability Failures. Any failures that are identified according to the stability program will be immediately communicated by DSM to Barrier. 

  

 Page 6 

	6.5	Out-of-Specification (OOS) Investigations 

  

	 	6.5.1	DSM is responsible for investigating any testing performed by DSM that is confirmed as a failure to meet Product specifications. Each investigation will be reviewed by DSM’s
Quality Assurance designee, and will follow internal procedures that are in accordance with regulatory guidelines. A copy of any final investigation report will be included in the release documentation package provided to Barrier.

  

	 	6.5.2	DSM will notify Barrier of all OOS results (confirmed and unconfirmed) at the time that they are generated. 

 ARTICLE 7: QUALITY ASSURANCE 
  

	7.1	Deviations and Investigations 

  

	 	7.1.1	Deviations: Any investigative, hazardous, or reportable deviation from the process during manufacture or OOS result shall be documented by DSM and approved by DSM Quality
Assurance and appropriate area management. DSM will notify Barrier of all deviations at the time they are generated. Barrier may, on a case by case basis, require review and signature authority for any deviation. A copy of any final investigation
report will be reviewed with Barrier and included in the Release Documentation package provided to Barrier. 

  

	 	7.1.2	DSM will notify Barrier of the disposition of any rejected Products. 

  

	 	7.1.3	DSM will notify Barrier if any problems are discovered that may impact Product lots previously shipped to Barrier on a timely basis in order to assure that regulatory reporting
guidelines may be met. 

  

	7.2	Lot Disposition. 

 For each lot, DSM will provide the
documentation required in Appendix III. 
  

	7.3	Quality Assurance Certificate of Compliance/Analysis 

  

	 	7.3.1	DSM will provide a standard Certificate of Analysis indicating the test results of each test performed as well as a signed Certificate of Compliance confirming that the Products
have been manufactured, tested, and stored according to the requirements of the Master Production Record and cGMP criteria. 

  

	 	7.3.2	 DSM will provide complete copies to Barrier of the lot documentation (Manufacturing Work Order, Packaging Work Order, OOS and Deviation Report) for the first ten
(10) commercial lots. Lot documentation for commercial lots beyond the first ten shall be subject to the mutual agreement of DSM and Barrier. Shipment of the first three lots will 

  

 Page 7 

	 	 
require prior authorization by Barrier. Additional copies, if requested by Barrier, shall be furnished by DSM upon reimbursement of DSM’s reasonable
copying costs. 

  

	7.4	Product Release 

  

	 	7.4.1	Release to Commerce. Release to commerce, shipment, and further distribution of the Products, once dispositioned by DSM for release, is the responsibility of Barrier’s
quality department. Barrier’s release to commerce shall be based on Barrier’s internal procedures, the full document package provided by DSM, and completion of any release testing required by Barrier Quality Control for its internal
release criteria. 

  

	 	7.4.2	Release Pending FDA Approval. In the event that the Barrier requests DSM to ship an unlicensed product to Barrier to be held until FDA approval has been granted, then Barrier
shall supply DSM with a written certification stating that “Product will not be released to commerce until regulatory approval has been obtained.” Upon receipt of such certification from Barrier, DSM will release product for shipment to
Barrier, but such release shall not constitute a release to commerce. 

  

	 	7.4.3	Shipment of Intermediate Product. In the event that an intermediate product is to be shipped to Barrier for further processing, DSM will release coded product for shipment if
all pre-defined intermediate release criteria are met. In such cases, further release to commerce of the finished product shall be the responsibility of Barrier. 

  

	 	7.4.4	Product Problems. Any problem discovered by Barrier likely to cause rejection of the approved Products will be communicated to DSM within thirty (30) days from receipt
of the full release documentation package (see Appendix III). 

  

	7.5	Product Complaints and Recalls 

  

	 	7.5.1	Product Complaints: Barrier is responsible for receiving and initially investigating any Product complaints. Barrier will notify DSM of any problems thought to be due to
manufacture which are found during the distribution of the product. Upon receipt of the notice of complaints, DSM will promptly perform investigations for these problems. Investigation reports will be forwarded to Barrier within thirty
(30) days following the date of receipt by DSM. Barrier is responsible for reporting any complaint to the appropriate regulatory authority including adverse drug events reports. Any complaint received by DSM will be immediately forwarded to
Barrier. 

  

	 	7.5.2	 Product Recall: Barrier, with data and assistance provided by DSM, is responsible for filing Field Alerts and initiating product recalls due to any defect
considered sufficiently serious. Barrier will provide DSM with a 

  

 Page 8 

	 	 
copy of any regulatory correspondence related to field alerts or recalls. In the event that DSM has reason to believe that any Products should be recalled or
withdrawn from distribution, DSM shall promptly inform Barrier in writing prior to taking any such action. Barrier shall notify the FDA, DEA, and any foreign regulatory agencies of any recall, and shall be responsible for coordinating all necessary
activities regarding the action taken. Barrier acknowledges and understands that DSM, as manufacturer of the Product, has significant regulatory obligations if there are any indications that recall or withdrawal would be necessary. Accordingly, DSM
and Barrier agree to cooperate fully regarding any proposed recall, product withdrawal, or field correction; and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required, to assure regulatory
compliance. 

  

	7.6	Records Retention 

  

	 	7.6.1	DSM will retain, at a minimum, lot production records for the Products and materials for the longer of one (1) year after the expiration of the lots or seven (7) years
from manufacture of lots. [See CFR 211.180] Validation records will be held for at least seven (7) years but may need to be held for longer than seven (7) years, considering the Product life cycle. 

  

	 	7.6.2	DSM will retain lot records for the expiry period of the Clinical Trial Materials for a maximum of three (3) years unless notified of a shorter retention period by Barrier, but
at a maximum of two (2) years past the marketing approval date in the last ICH region. [See CFR 312.57] 

  

	7.7	Quality Assurance Presence in the Manufacturing Facility 

  

	 	7.7.1	DSM will maintain adequate Quality Assurance presence in the manufacturing facility during the manufacture of the Products to ensure compliance with GMPs. 

 

	 	7.7.2	DSM will permit Barrier’s presence in the manufacturing facility during the manufacture of the Products upon reasonable prior notice by Barrier’s quality group.

 ARTICLE 8: REGULATORY COMPLIANCE 
  

	8.1	Regulatory Inspections 

  

	 	8.1.1	DSM will immediately inform Barrier of any regulatory inspections that may involve the Products and permit a representative from Barrier Quality to be present, if required by
Barrier. 

  

	 	8.1.2	DSM will secure Barrier’s agreement prior to making any commitment to a regulatory agency regarding Barrier’s Products. 

  

 Page 9 

	 	8.1.3	Additionally, DSM will immediately forward to Barrier any regulatory correspondence on the Products or on other system related issues that support manufacturing, packaging, or
testing for Barrier Products. Barrier will be involved in the finalization of DSM responses to those issues that are specific to Barrier’s product. This an important part of the harmonious working relationship between DSM and Barrier.

  

	 	8.1.4	Barrier will immediately inform DSM in writing of any regulatory issue that impacts DSM’s ability to manufacture the Products. 

  

	8.2	Regulatory Actions 

  

	 	8.2.1	Barrier will notify DSM of any regulatory actions on the Products that may impact DSM. Barrier will promptly forward any regulatory correspondence on the Products to DSM.

  

	 	8.2.2	DSM is responsible for supporting all lot record investigations associated with regulatory actions. 

  

	 	8.2.3	DSM agrees to supply Barrier with any manufacturing, testing, or storage data relating to the Product within two (2) business days, if requested, as the result of a regulatory
inspection, or a potential regulatory exposure such as a recall or significant product complaint. 

  

	8.3	Regulatory Affairs 

  

	 	8.3.1	Barrier is responsible for ensuring all appropriate regulatory filings and import/export documentation are filed with regulatory agencies prior to shipment/human administration.

  

	 	8.3.2	DSM Quality Assurance/Regulatory Affairs (“DSM QA/RA”) will act as the point of contact between Barrier’s regulatory affairs staff or consultant regarding issues that
impact the CMC registration information for the drug substances and/or drug product. 

  

	 	8.3.3	DSM QA/RA will provide Barrier with agreed finalized CMC documentation covered in the Supply Agreement and this Quality Agreement. 

  

	 	8.3.4	DSM QA/RA will perform a technical/regulatory review of all documentation provided to Barrier to support regulatory submission. 

  

	 	8.3.5	Barrier will be responsible for making final decisions regarding CMC regulatory strategy and will document such decisions for DSM. 

  

	 	8.3.6	Barrier will provide to DSM QA/RA a copy of applicable sections of Barrier’s final regulatory submissions, for reference during inspections. 

  

 Page 10 

	 	8.3.7	DSM QA/RA will provide support for Barrier with respect to proposing appropriate CMC regulatory strategies and identifying potential regulatory consequences for issues involving
drug products. 

  

	8.4	Right to Audit 

  

	 	8.4.1	DSM will allow representatives from Barrier Quality to have access to manufacturing, warehousing, laboratory premises, and records relating to Barrier’s Products for audit
purposes pursuant to this Section 8.4. Barrier representatives will be escorted at all times by DSM personnel. 

  

	 	8.4.2	Barrier will provide a thirty (30) days notification for all planned audits, with actual audit dates subject to mutual agreement with DSM. 

  

	 	8.4.3	DSM will permit Barrier Quality to conduct preparatory audits either for initiation of GMP manufacture of the Products or for preapproval inspections (PAI).

  

	 	8.4.4	DSM will permit Barrier Quality to conduct audits to address significant product quality or safety problems. 

  

	 	8.4.5	DSM will permit Barrier Quality to perform one standard GMP compliance audit per year. 

  

	8.5	Audit Closeout 

  

	 	8.5.1	An exit meeting will be held with representatives from DSM and Barrier to discuss significant audit observations. 

  

	 	8.5.2	Barrier will provide a written report of all observations within thirty (30) days to DSM. Within thirty (30) days of the audit report receipt, DSM will provide a written
response to all findings that details corrective action to be implemented. DSM will follow up to ensure that all corrective actions are implemented within ninety (90) days. 

  

	8.6	GMP Documentation. 

 Neither party shall make any changes
to GMP documentation without the consent of the other party, in order to insure that all GMP documentation, which is maintained at DSM and subject to regulatory review, matches or is consistent with information filed with regulatory authorities.

 ARTICLE 9: DISPUTE RESOLUTION 
 In the event that a dispute arises between DSM and Barrier regarding the nonconformity of a lot of the Products or regarding other matters, the senior management of the quality departments from both companies shall in good faith promptly
attempt to resolve disputed issues. If the parties cannot reach agreement, 

  

 Page 11 

 
the matter shall be resolved in accordance with dispute resolution provisions of the Supply Agreement. Barrier may only dispute a lot of Product which has
been dispositioned by DSM for release. Financial liability shall be determined according to the Supply Agreement. 
 ARTICLE 10: CHANGE MANAGEMENT

  

	10.1	Technical & cGMP Impact Assessment 

  

	 	10.1.1	All changes to the Product and related documents shall proceed through a technical and cGMP impact assessment by DSM’s quality and change management personnel. The documents
which (a) contain changes that may affect Barrier’s regulatory submissions or the support system and/or which (b) have a direct impact on the quality systems affecting Barrier’s product, will also be reviewed and assessed by
Barrier for regulatory advice and implementation requirements, as per the agreements between Barrier and DSM. DSM shall not change any document that has a cGMP impact upon Barrier products without the prior consent of Barrier.

  

	 	10.1.2	The scope of such a Change Management process includes chemical manufacturing, pharmaceutical manufacturing and packaging processes. The associated changes may relate to: the Master
Production Control Records (e.g. Master Formulas, Filling Work Orders, Packaging Work Orders); Bills of Materials; Analytical Standards and Test Methods (for Raw Materials and Finished Products); Stability Protocols; Purchase Specifications (for Raw
Materials and Packaging Components); and Barrier specific Validated Equipment, Facilities, Utilities or Computer Systems. 

 ARTICLE 11:
PRODUCT AND PROCESS VALIDATION 
  

	11.1	Process Validation 

 DSM is responsible for ensuring that
the manufacturing process is validated. The validation should ensure, with a high degree of certainty, that the process is consistently capable of consistently achieving the Product’s acceptance criteria. 
  

	11.2	Cleaning Validation 

 DSM is responsible for ensuring that
adequate cleaning is carried out between lots of different products to prevent contamination. Data should be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of
the same product. Barrier will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) and establish cleaning limits with DSM assistance. 
  

 Page 12 

	11.3	Equipment, Computer, Facility, and Utilities Qualification 

 DSM is responsible for all equipment, computer, facility, and utility qualification/ validation activities associated with the Products. 
  

	11.4	Laboratory Qualification 

 DSM is responsible for ensuring
that all laboratories are in compliance with applicable cGMP’s guidelines. If analytical work is performed at DSM then Barrier will also provide any existing analytical documentation to assist in methods transfer or methods validation. In
addition, if analytical work is not performed at the Greenville site, DSM may elect to perform an audit on vendors to be used for analytical testing. DSM will be responsible for insuring that any vendor selected by DSM is practicing within cGMP
compliance. Vendors selected by Barrier must be certified by Barrier and acceptable per cGMP. 
 ARTICLE 12: ANNUAL PRODUCT REVIEW, ANNUAL REPORT AND
DRUG LISTING 
  

	12.1	Annual Product Review 

 DSM will perform an Annual Product
Review for the Products and will issue a report to Barrier. This report will cover all manufacturing, testing, and storage activities performed by DSM. It will contain a review of any changes at DSM in the manufacturing, testing, storage or
validation of the Products in the previous calendar year and a summary of lots made, released, investigated and rejected. Also, control charting or trend analysis of key product parameters will be performed. 
  

	12.2	Annual Report 

 Barrier is responsible for preparing any
Annual Report as required by applicable regulations, including 21 CFR 314.70, 314.81, and/or 601.12. At least ninety (90) calendar days before the Annual Report due date, Barrier shall request in writing from DSM the chemistry, manufacturing,
and controls data required for submission of the Annual Report. DSM will provide the requested information to Barrier within thirty (30) days. 
  

	12.3	Drug Listing 

 DSM is responsible for drug listing as the
manufacturer of the Products for Barrier, while Barrier is responsible for drug listing as the distributor of the Products. Barrier will provide DSM with all required information needed to register the Products. Barrier will notify DSM of the
scheduled Product launch, where applicable. 
 [Appendices are attached] 
  

 Page 13 

 APPENDIX I: SPECIFICATIONS FOR THE PRODUCTS QUALITY AGREEMENT 
  

	 	•	 	 Zimycan ointment 5gm, 30gm, & 60gm 

 APPENDIX II: LIST OF QUALITY CONTACTS QUALITY AGREEMENT 
  

					
	 ISSUE
	  	 BARRIER
	  	 DSM

	 Product Release
	  	***	  	***
			
	 QC Testing
	  	***	  	***
			
	 Investigations
	  	***	  	***
			
	 Regulatory Affairs
	  	***	  	***
			
	 Validation
	  	***	  	***
			
	 Compliance Audits
	  	***	  	***
			
	 Product Complaints
	  	***	  	***
			
	 Change Management
	  	***	  	***

 APPENDIX III: RELEASE DOCUMENTATION 
 The lot release document package will include a Certificate of Analysis (“COA”) and a Certificate of Compliance (“COC”). 
 Certificate of Analysis: A COA which is generated by DSM Quality Assurance/Regulatory Affairs will be provided and will include the name of the Products, lot number, date of manufacture, and analytical
specifications. The COA will list the release tests performed by DSM laboratories (and/or qualified third-party laboratories) and actual test results. 
 Certificate of Compliance: The COC will attest to the fact that the lot of Products was made in accordance with all applicable regulations, licenses, and company policies. This document will include the lot quantity approved, the
final lot yield, and the expiration date. It will also include a listing of all investigations for the lot. 
 As requested by Barrier, DSM shall provide the
following Lot Documentation in the Release Documentation Package: 
  

	 	(a)	Manufacturing Work Order; 

  

	 	(b)	Packaging Work Order; 

  

	 	(c)	Out-of-Specification (OSS) Investigation Report; and 

  

	 	(d)	Deviation Investigation Report. 

 APPENDIX IV: OUTLINE OF RESPONSIBILITIES 
  

					
	 FUNCTION
	  	DSM	  	BARRIER
	 MANUFACTURING
	  	X	  	
	 In-Process TESTING (Physical, Chemical Microbial)
	  	X	  	
	 FP TESTING – Physical, Chemical
	  	X	  	
	 FP TESTING – Sterility
	  	X	  	
	 FP RELEASE
	  	X	  	X
	 DISTRIBUTION
	  		  	X
	 FP RETAINS
	  	X	  	
	 FP STABILITY
	  	X	  	
	 C OF A
	  	X	  	
	 BATCH RECORD REVIEW/SIGNOFF
	  	X	  	X
	 INVESTIGATIONS INTO DEVIATIONS AND NON-CONFORMANCES
	  	X	  	
	 COMPLAINT RECEIPTS
	  		  	X
	 COMPLAINT INVESTIGATIONS
	  	X	  	X
	 ADVERSE EVENT REPORTS
	  	X	  	X
	 FIELD ALERT REPORTS
	  		  	X
	 RECALLS
	  		  	X
	 CUSTOMER RETURNS
	  		  	X
	 RAW MATERIAL (Active) ORDERS
	  	X	  	
	 RAW MATERIAL (Active) TESTING and Release
	  	X	  	
	 RAW MATERIAL (Inactives/Printed Packaging Materials) ORDERS
	  	X	  	
	 RAW MATERIAL (Inactives/Printed Packaging Materials) TESTS
	  	X	  	
	 RAW MATERIAL (Inactives/Printed Packaging Materials) RELEASE
	  	X	  	
	 SUPPLIER AUDITS (Active)
	  	X	  	X
	 SUPPLIER AUDITS (Inactives/Printed Packaging Materials)
	  	X	  	
	 MAINTENANCE OF VENDOR LISTS
	  	X	  	
	 NOTICE OF PROPOSED CHANGES
	  	X	  	
	 DOCUMENT CHANGE CONTROL
	  	X	  	
	 ANNUAL Product REVIEW
	  	X	  	

 EXHIBIT 7: REGULATORY SUPPORT 

 EXHIBIT 8: PRICING FOR DEVELOPMENT / CTM ACTIVITIES 
 All development / transfer / stability costs are subject to increase annually at a percentage amount equal to the percentage increase in the Producer Price Index
(Pharmaceutical Preparations, ethical PCU2834#). 
 Associated Transfer Estimate: 
 Completed and Invoiced Activities 
  

					
	 Description of Service
	  	Price	 
	 Project Administration Activities
	  	$	*	**
	 EHS Evaluation & Follow-up
	  	$	*	**
	 Analytical Dev/Trans/Val- Prod. &RM, Disso Comp
	  	$	*	**
	 Item# & Analytical Std Creation/Revision
	  	$	*	**
	 RM/Component / Pkg. Procurement, Testing
	  	$	*	**
	 In-Scope Regulatory Filing Docs (Data Only Pkg.)
	  	$	*	**
	 Summary Dev/TT/Val Report
	  	$	*	**

 Activities Not Complete and Scope Changes In Discussion 
  

			
	 Description of Service
	  	 Price

	 In-Scope Regulatory Filing Docs (Data Only Pkg.)
	  	$***
		
	 Validation Master Plan Creation
	  	  ***
		
	 Summary Dev/TT/Val Report
	  	  ***
		
	 PQ/ Validation Batch Doc, Mfg, Release
	  	  ***
		
	 PQ/Validation Batch Val Activities
	  	  ***
		
	 Analytical Testing Scope Changes – Miconazole RS Matrix/Placebo
	  	  ***
		
	 Analytical Standard Revision for use of Matrix/Placebo
	  	  ***
		
	 Development Comparability Report
	  	  ***
		
	 Bulk Manufacturing In-Process Testing
	  	  ***
		
	 Solution Stability of the standard, sample, and mobile phase preparations for the Miconazole Nitrate assay and Impurities
assay
	  	  ***

			
	 Release Guidelines for Miconazole Nitrate and Zinc Oxide
	  	  ***
		
	 Analytical Cleaning Verification Method for Zinc Oxide
	  	  ***
		
	 Zinc Oxide Titration Assay Study
	  	  ***
		
	 Analytical Standard Revision for CTM Stability
	  	  ***
		
	 Line Tests for 30 Gram Tubes
	  	  ***
		
	 Line Tests for 5 Gram Tubes
	  	  ***
		
	 Full Cleaning After Each 30 Gram Validation Batch (3 Batches Total)
	  	$***
		
	 30 Gram Physician Sample Tube Unit Price and Related Activities
	  	  ***
		
	 45 Gram Tube Unit Price and Related Activities
	  	  ***

	1.	Activities based upon packaging configuration below. 

  

			
	30 Gram
	 Component
	  	 Dimensions

	 Tube (Aluminum)
	  	130 mm (H) x 22 mm (D)
	 Carton (4 Panels)
	  	37.00 mm (L) x 36.00 mm (W) x 145.00 mm (H)
	 Insert (Roll Feed)
	  	7 1/2 in (L) x 12 1/8 in (W) (max size)
	 Shipper
	  	72 per Shipper Bundled by 12
	5 Gram
	 Component
	  	 Dimensions

	 Tube (Aluminum)
	  	93 mm (H) x 13.5 mm (D)

 Development Batch Costs: 
  

			
	 Completed and Invoiced
Activities

	 ***
	  	Total estimated price / batch
		
	 ***
	  	$***
		
	 ***
	  	$***
		
	 ***
	  	$***
		
	 ***
	  	$***
	
	 Activities Not
Completed

	 ***
	  	  ***
		
	 ***
	  	$***

  

	1.	API not included. Excipients and tubes included as estimates. Will ***. 

  

	2.	Batch costs are not included in the associated transfer costs. 

					
	 Stability Estimate:
	  	Registration = $***	 	
		  	Placebo = $***	 	
		  	CTM = $***	 	
		  	PQ / Validation = ***	 	

  

	l.	. 

  

	2.	Assumes three (3) Registration batches each split into two (2) packaging configurations; ***. A total of six (6) studies will be placed on stability, sampled and
tested simultaneously. 

  

	3.	If the batches are placed on stability at different times, then pricing will need to adjust accordingly. 

  

	4.	Pricing does not include optional timepoints. 

 EXHIBIT 9: MATERIAL LEAD TIMES 
  

			
	 Material
	  	Lead time
	 Aluminum Unprinted Tube
	  	***
		
	 Zinc Oxide
	  	***
		
	 White Petrolatum
	  	***
		
	 Fragrance, Lilac
	  	***
		
	 Miconazole Nitrate
	  	***Manufacturing Agreement

 Exhibit 10.33 
 Confidential Treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as “***”. A complete version of this exhibit
has been filed separately with the Securities and Exchange Commission. 
 MANUFACTURING AGREEMENT 
 DPT LABORATORIES, LTD. 
 AND

 BARRIER THERAPEUTICS, INC. 
 Table of Contents 
  

							
	 I - DEFINITIONS
	  	5
				
		 	1.1	 	Act	  	5
				
		 	1.2	 	FDA	  	5
				
		 	1.3	 	Forecasted Needs	  	5
				
		 	1.4	 	Label, Labeled, or Labeling	  	5
				
		 	1.5	 	Manufacturing Fee	  	6
				
		 	1.6	 	Market Year	  	6
				
		 	1.7	 	Materials Fee	  	6
				
		 	1.9	 	Packaging	  	7
				
		 	1.10	 	Product(s)	  	7
				
		 	1.11	 	Specifications	  	7
		
	II - PRODUCT MANUFACTURE AND SUPPLY	  	7
				
		 	2.1	 	Manufacture and Purchase	  	7
				
		 	2.2	 	Supply of Materials	  	7
				
		 		 	 (a) Materials Supplied by COMPANY
	  	7
				
		 		 	 (b) Materials Supplied by DPT
	  	8
				
		 		 	 (c) Packaging and Labeling
	  	8
				
		 	2.3	 	Materials Testing	  	8
				
		 	2.4	 	Material Safety Data Sheets	  	9

  

 - 1 - 

							
				
		 	2.5	 	Commencement of Manufacturing for New Products	  	9
				
		 	2.6	 	Purchase Orders	  	9
				
		 		 	(a) Purchase of Products	  	9
				
		 		 	(b) Forecasted Needs	  	9
				
		 		 	(c) Time of Issuance	  	10
				
		 		 	(d) Contents of Purchase Orders	  	10
				
		 	2.7	 	Rejected Products	  	10
				
		 		 	 (a) Rejection of Product by COMPANY
	  	10
				
		 		 	 (b) Replacement of Rejected Product
	  	11
				
		 		 	 (c) Responsibility for Costs
	  	11
				
		 		 	 (d) Resolution of Conflict
	  	11
				
		 	2.8	 	Product Price	  	12
				
		 		 	 (a) Manufacturing Fees
	  	12
				
		 		 	 (b) Materials Fees
	  	12
				
		 	2.9	 	Payment	  	12
				
		 	2.10	 	Late Payment	  	13
				
		 		 	 (a) Late Fee
	  	13
				
		 		 	 (b) Collateral Security
	  	13
				
		 	2.11	 	Disposal Costs	  	13
		
	 III - SHIPMENT AND RISK OF LOSS
	  	13
				
		 	3.1	 	Shipment	  	13
				
		 	3.2	 	Delivery Terms	  	14
				
		 	3.3	 	Claims	  	14
		
	 IV - TERM AND TERMINATION
	  	14
				
		 	4.1	 	Term	  	14
				
		 	4.2	 	Termination	  	14
				
		 	4.3	 	Payment on Termination	  	15
				
		 	4.4	 	Survival	  	15
		
	 V - CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
	  	15
				
		 	5.1	 	Certificates of Analysis	  	15
				
		 	5.2	 	Stability Testing	  	15
				
		 	5.3	 	Validation Work or Additional Testing	  	15
				
		 	5.4	 	FDA Inspection	  	16
				
		 	5.5	 	Regulatory Filings	  	16

  

 - 2 - 

							
	 VI - WARRANTIES
	  	16
				
		 	6.1	 	Conformity with Specifications	  	16
				
		 	6.2	 	Compliance with the Act	  	16
				
		 	6.3	 	Conformity with FDA Regulations and cGMP’s	  	17
				
		 	6.4	 	Compliance of Packaging and Labeling with Laws and Regulations	  	17
				
		 	6.5	 	Access to DPT’s Facilities	  	18
				
		 	6.6	 	Disclaimer	  	18
		
	 VII - PRODUCT RECALLS
	  	18
		
	 VIII - FORCE MAJEURE
	  	19
		
	 IX - CHANGES TO PROCESS OR PRODUCT
	  	19
				
		 	9.1	 	Changes by COMPANY	  	19
				
		 	9.2	 	Changes by DPT	  	19
				
		 	9.3	 	Changes by Regulatory Authorities	  	19
				
		 	9.4	 	Obsolete Inventory	  	20
		
	 X - CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS
	  	20
				
		 	10.1	 	Confidential Information	  	20
				
		 		 	 (a) Obligations of Confidentiality
	  	20
				
		 		 	 (b) Exceptions
	  	21
				
		 		 	 (c) Competing Products
	  	21
				
		 	10.2	 	Trademarks and Trade Names	  	21
		
	 XI - RESEARCH & DEVELOPMENT SERVICES
	  	22
		
	 (PURPOSELY DELETED)
	  	22
		
	 XII - INDEMNIFICATION
	  	22
				
		 	12.1	 	Indemnification by DPT	  	22
				
		 	12.2	 	Indemnification by COMPANY	  	22
				
		 	12.3	 	Patent and Other Intellectual Property Rights	  	22
				
		 		 	 (a) Warranty by COMPANY
	  	22
				
		 		 	 (b) Indemnification by DPT
	  	22
				
		 	12.4	 	Conditions of Indemnification	  	23
				
		 	12.5	 	Evidence of Liability Insurance	  	23
		
	 XIII - GENERAL PROVISIONS
	  	23
				
		 	13.1	 	Notices	  	23
				
		 	13.2	 	Entire Agreement; Amendment	  	24
				
		 	13.3	 	Waiver	  	24
				
		 	13.4	 	Obligations to Third Parties	  	24
				
		 	13.5	 	Assignment	  	24

  

 - 3 - 

							
				
		 	13.6	 	Governing Law	  	25
				
		 		 	(a) Governing Law	  	25
				
		 		 	 (b) Arbitration
	  	25
				
		 		 	 (c) Costs
	  	27
				
		 	13.7	 	Severability	  	27
				
		 	13.8	 	Headings, Interpretation	  	27
				
		 	13.9	 	Counterparts	  	27
				
		 	13.10	 	Independent Contractor	  	27

  

 - 4 - 

 This Manufacturing Agreement (the “Agreement”) is made as of this 31st day of March, 2005 by
and between Barrier Therapeutics, Inc., a corporation organized under the laws of the State of Delaware, with its principal place of business at 600 College Road East, Princeton, New Jersey 08540 (hereinafter referred to as “COMPANY”) and
DPT Laboratories, Ltd., a Texas Limited Partnership with a place of business at 307 East Josephine Street, San Antonio, Texas 78215 (hereinafter referred to as “DPT”). 
 WITNESSETH: 
 WHEREAS, COMPANY is engaged in the distribution and sale of
certain topical pharmaceutical products; and 
 WHEREAS, DPT owns and has a broad spectrum of technologies for the development, formulation,
testing, control, manufacture, filling and distribution of pharmaceutical, over-the-counter and cosmetic products; and 
 WHEREAS, COMPANY
desires DPT to manufacture the Products hereinafter defined to COMPANY, and DPT desires to do so. 
 NOW, THEREFORE, in consideration of the
mutual covenants hereinafter expressed, the parties agree as follows: 
 I -DEFINITIONS 
  

	1.1	Act 

 “Act” means the Federal Food, Drug
and Cosmetic Act, as amended, and regulations promulgated thereunder. 
  

	1.2	FDA 

 “FDA” means the United States Food
and Drug Administration, or any successor entity thereto. 
  

	1.3	Forecasted Needs 

 “Forecasted Needs”
means COMPANY’s estimate of Products to be ordered from DPT for each of the twelve (12) months following the month in which such estimate is provided. 
  

	1.4	Label, Labeled, or Labeling 

 “Label”,
“Labeled”, or “Labeling” means all labels and other written, printed, or graphic matter upon: (i) Product or any container or wrapper utilized with Product or (ii) any written material accompanying Product. 

 

 - 5 - 

	1.5	Manufacturing Fee 

 “Manufacturing Fee”
means the fee paid by COMPANY to DPT for services required to manufacture and package Products. The Manufacturing Fee is quoted in single final Product unit increments (i.e. by the bottle or tube). The Manufacturing Fee shall include services for
incoming inspection of materials, compounding of bulk, packaging Product, testing Product for release and marketed product annual stability, making Product ready for shipment, and minimum product documentation (one copy of Certificate of Analysis.)
The Manufacturing Fee does not include, without limitation, any research & development support, package engineering studies, validation support, FDA audit support, extensive reporting requirements, or additional laboratory testing performed
by an outside testing laboratory or testing beyond that required in the Specifications. These services are in addition to the Manufacturing Fee and shall be billed by the hour at DPT’s then-prevailing R&D hourly rate in accordance with
Section XI contained herein. In addition, the Manufacturing Fee does not include warehousing or distribution of Product, any materials costs or costs associated with establishing or manufacturing new materials such as art charges, die costs, plate
costs, and packaging equipment change parts. 
  

	1.6	Market Year 

 “Market Year” means a period
of twelve (12) consecutive months commencing on the first day of the month following the initial invoicing of Product commercially manufactured by DPT in accordance with this Agreement and beginning on January 1st of each consecutive year
thereafter. 
  

	1.7	Materials Fee 

 “Materials Fee” is quoted
in single final Product unit increments and is defined as ***. Materials Fee does not include, without limitation, costs associated with establishing, testing or manufacturing components or new materials such as reference standards, reagents, art
charges, die costs, mold or tooling costs, plate costs, and packaging equipment change parts. These items will be invoiced to COMPANY at DPT’s cost on a net thirty (30) basis and COMPANY agrees to reimburse DPT for any such authorized
expenditures made on COMPANY’s behalf. 
  

	1.8	Material Safety Data Sheet 

 “Material Safety
Data Sheet” (“MSDS”) means written or printed material concerning a hazardous chemical which is prepared in accordance with the regulations promulgated by the Occupational Safety & Health Administration, or any successor
entity thereto. 
  

 - 6 - 

	1.9	Packaging 

 “Packaging” means all primary
containers, cartons, shipping cases, inserts or any other like material used in packaging, or accompanying, Product. 
  

	1.10	Product(s) 

 “Product(s)” means product(s)
(as listed in Schedule A) _manufactured, packaged, labeled and/or finished by DPT to meet the Specifications (as hereinafter defined). 
  

	1.11	Specifications 

 “Specifications” means
the (i) raw material specifications (including chemical, micro, and packaging specifications); (ii) sampling requirements (i.e., lab, chemical, and micro); (iii) compounding module, including compounding process and major equipment;
(iv) intermediate specifications; (v) packaging module (including packaging procedures, torque and fill weights); (vi) any and all COMPANY product, synthesis, formula, processing and quality control specifications and
(vii) finished Product specifications release criteria including DPT’s Acceptable Quality Limits (“AQL’s”). Specifications shall be established and/or amended from time to time upon the written agreement of both DPT and
COMPANY via a Product Change Request (“PCR”) in accordance with Section IX below. 
 II -PRODUCT MANUFACTURE AND SUPPLY

  

	2.1	Manufacture and Purchase 

 Subject to the terms and
conditions of this Agreement, DPT agrees that it will manufacture for and provide to COMPANY, and COMPANY agrees that it will purchase from DPT, one hundred percent (100%) of the COMPANY’s requirements of the Products. COMPANY shall pay
DPT for Products according to paragraph 2.8 below. DPT shall manufacture Products in accordance with the Specifications or pursuant to exceptions approved by COMPANY, and in sufficient quantity to meet COMPANY’s Forecasted Needs for the length
of this Agreement. 
  

	2.2	Supply of Materials 

  

	 	(a)	Materials Supplied by COMPANY 

 If COMPANY
is to supply any material for manufacture of Products as set forth under this Section, COMPANY shall notify DPT, in writing, specifying which materials it will supply. COMPANY shall provide DPT with said materials at COMPANY’s expense along
with Certificates of Analysis and 

  

 - 7 - 

 
MSDS sheets relating to same, at a minimum of thirty (30) days prior to DPT’s scheduled production of Product requiring said materials and in
sufficient amounts for DPT’s manufacture of Product but not to exceed quantities necessary to support three (3) months of the most recently supplied Forecasted Needs or the minimum order quantity whichever is greater. COMPANY supplied
material in excess of these amounts shall be either subject to storage fees or returned to COMPANY. All COMPANY supplied material shall be shipped to DPT freight prepaid. In the event COMPANY ships or causes to ship such material freight collect,
DPT shall invoice COMPANY for the cost of the freight plus a reasonable administrative fee which invoice shall be paid promptly upon receipt. DPT is hereby authorized by COMPANY to return any portion of COMPANY supplied material for which no future
production is planned. COMPANY shall be responsible for the quality of all COMPANY-supplied materials. COMPANY shall be responsible for the payment of all personal property and other taxes incident to the storage of COMPANY-owned material at DPT.
For each lot of materials supplied by COMPANY, DPT shall perform the quality control and inspection tests as agreed to in the Specifications unless COMPANY has made arrangements in writing for pre-approved material. DPT shall have the right to
reject any pre-approved material which does not meet the Specifications in accordance with paragraph 2.3 below. DPT warrants that it will maintain, for the benefit of COMPANY, complete and accurate records of the inventory of all such
COMPANY-supplied materials. If requested by COMPANY, DPT will provide to COMPANY a monthly report of ending monthly inventory balance of each COMPANY supplied/owned materials stored at DPT. This reporting will be supplied exclusively on DPT forms.

  

	 	(b)	Materials Supplied by DPT 

 DPT shall be
responsible for supply, at the expense of COMPANY of all other commodities necessary for the manufacture of Products. All DPT supplied materials will be billed to COMPANY on the respective invoice for Product, into which the DPT supplied materials
was converted, as part of the Materials Fee, and in addition to the Manufacturing Fee, all in accordance with the provisions of paragraph 2.8 below. 
  

	 	(c)	Packaging and Labeling 

 COMPANY shall
provide DPT with Specifications (including art proofs) for Packaging and Labeling, and DPT shall purchase, at the expense of COMPANY, Packaging and Labeling in accordance with the Specifications. 
  

	2.3	Materials Testing 

 All materials and packaging
supplies shall, when received by DPT, be submitted 

  

 - 8 - 

 
to analysis and evaluation in accordance with DPT’s SOP’s to determine whether or not said materials meet the Specifications. The cost of all such
analyses and evaluations shall be borne by DPT, except as otherwise provided in paragraph 2.2 of this Agreement. DPT agrees to maintain and, if necessary, make available records of all such analyses and evaluations. 
  

	2.4	Material Safety Data Sheets 

 Prior to DPT’s
receipt and testing, and as a condition precedent of any testing or formulation work by DPT pursuant to this Agreement, COMPANY shall provide MSDS sheets to DPT for finished products and all components necessary for the manufacture of Products. Any
components or Products requiring disposal shall be presumed hazardous unless otherwise provided in the MSDS information provided. 
  

	2.5	Commencement of Manufacturing for New Products 

 No
later than three (3) months prior to the initial Market Year of a new Product added to this Agreement, COMPANY agrees to notify DPT of its delivery requirements, including firm orders for same, for the three (3) months and shall provide
its Forecasted Needs for the first Market Year in order to ensure timely delivery of Product for initial sale and marketing. 
  

	2.6	Purchase Orders 

  

	 	(a)	Purchase of Products 

 COMPANY agrees to
purchase from DPT all Products manufactured for COMPANY by DPT in accordance with COMPANY’s purchase orders or Forecasted Needs to the extent such Products meet the Specifications or exceptions approved by COMPANY. Products shall be ordered by
COMPANY by the issuance of separate, pre-numbered purchase orders in increments of full batches and in minimum order quantities. 
  

	 	(b)	Forecasted Needs 

 No later than three
(3) months prior to the initiation of the first Market Year and thereafter at the end of each month, COMPANY shall provide DPT with specific data as to its Forecasted Needs. It is understood and agreed that with respect to all Forecasted Needs
issued to DPT by COMPANY pursuant to the terms hereof, the forecast for the first three (3) months thereof shall constitute a firm order for Products, regardless of receipt of COMPANY’s actual purchase order. DPT may produce Product up to
thirty (30) days prior to the requested delivery date in order to accommodate fluctuations in production demands. The second three (3) months of the period addressed in all Forecasted Needs shall be utilized by DPT for purposes of material
acquisition on behalf of COMPANY and DPT production planning. DPT shall attempt to minimize the material 

  

 - 9 - 

 
inventory purchased on behalf of COMPANY. Certain materials, however, may have long lead times and/or require a minimum order quantity. Therefore, DPT may
order the chemical and packaging components necessary to support up to six (6) months of COMPANY’s Forecasted Needs, or the applicable minimum order quantity, whichever is greater. Should COMPANY subsequently reduce its Forecasted Needs,
COMPANY will be financially responsible for any material purchased by DPT on COMPANY’s behalf. DPT may require a deposit for such materials and such materials may also be subject to storage and inventory carrying cost fees. 
  

	 	(c)	Time of Issuance 

 COMPANY shall issue
written purchase orders for Products to DPT at least ninety (90) days prior to the requested delivery dates if the requirements are at or below one hundred twenty-five percent (125%) of the applicable Forecasted Needs, and at least one
hundred twenty (120) days prior to the requested delivery dates if the requirements exceed the Forecasted Needs by more than one hundred twenty-five percent (125%). 
  

	 	(d)	Contents of Purchase Orders 

 COMPANY’s
purchase orders shall designate the desired quantities of Products, delivery dates and destinations. This Agreement allows for up to three (3) shipping destinations per batch of Product. Additional destinations can be accommodated for a
shipping preparation fee to be negotiated by DPT and COMPANY. 
  

	2.7	Rejected Products 

  

	 	(a)	Rejection of Product by COMPANY 

 COMPANY
may reject any Product which fails to meet the Specifications(“Rejected Product”). COMPANY shall, within twenty (20) days after its receipt of any shipment of Product and related Certificate of Analysis of Product batch (as described
in paragraph 5.1 hereof), notify DPT in writing of any claim relating to rejected Product batch and, failing such notification, shall be deemed to have accepted such Product batch. Such notice (the “Rejection Notice”) to DPT shall specify
why the Product batch failed to conform to Specifications. COMPANY shall grant to DPT the right to inspect or test said Product batch. All Products shall be submitted to inspection and evaluation in accordance with DPT’s SOP’s to determine
whether or not said Products meet the Specifications. If the reason for rejection set forth in the Rejection Notice is not one that affects the safety, efficacy or marketability of the Product, than the parties shall cooperate in good faith to
assess whether the Product may be released. 
  

 - 10 - 

	 	(b)	Replacement of Rejected Product 

 As to any
Rejected Product pursuant to paragraph 2.7(a) above (including phases of or complete batches of bulk product), DPT shall replace such Rejected Product (in an agreed upon batch order quantity, but in no event less than full batch increments) promptly
after all materials are available to DPIT for the manufacture. If requested, DPT shall make arrangements with COMPANY for the return or disposal of Rejected Product. 
  

	 	(c)	Responsibility for Costs 

 For the initial
three (3) batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY supplied information, formulations or materials, COMPANY shall bear one hundred percent (100%) of all costs
directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY in accordance with all applicable laws and regulations. Upon the completion of all necessary validation
and in the event a validated Product is rejected due to DPT’s failure to comply with applicable written procedures and such failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees,
costs of all materials supplied by DPT and costs of destruction. In the event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY supplied information or DPT’s
failure to follow written procedures, the COMPANY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be shared equally. Destruction of Rejected Product shall be in accordance
with all applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such
Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.

  

	 	(d)	Resolution of Conflict 

 In the event of a
conflict between the test results of DPT and the test results of COMPANY with respect to any shipment of Product batch, a sample of such Product batch shall be submitted by DPT to an independent laboratory acceptable to both parties for testing
against the Specifications utilizing the methods set out in the Specifications. The fees and expenses of such laboratory testing shall be borne entirely by the party against whom such laboratory’s findings are made. If results from the
independent laboratory are inconclusive, final resolution will be settled in accordance with paragraph 13.6 (b) below. 
  

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	2.8	Product Price 

  

	 	(a)	Manufacturing Fees 

 The initial
Manufacturing Fees to be paid by COMPANY to DPT are listed in Schedule A. The parties hereto agree that the Manufacturing Fees set out in Schedule A shall be ***. In addition, *** are based on ***. *** in the event that ***. If the parties are ***
in the most recently published monthly ***. Prices for new Products or new Product sizes, not initially included in Schedule A, shall be negotiated and DPT and COMPANY shall arrive at a mutual agreement with respect to prices at the time said new
Products or new Product sizes are added to Schedule A. If a negotiated price cannot be agreed upon, final pricing for any of the above will be settled in accordance with paragraph 13.6(b) below. 
  

	 	(b)	Materials Fees 

 The Materials Fee to be
paid by COMPANY to DPT shall be listed in Schedule A within ninety (90) days of commencement of the initial commercial products of the applicable Product. The Materials Fee will be adjusted once annually at the beginning of each calendar year
and Schedule A shall be amended accordingly based on changes in DPT’s standard costs for materials. In the event, however, the cost of a material increases or decreases during any Market Year greater than ***, DPT may promptly upon the
effective date of such increase or decrease adjust its invoice price for said material to COMPANY to compensate for the increase or decrease. 
  

	2.9	Payment 

 Payment for all deliveries of Product and
services shall be made in U.S. dollars, net thirty (30) days, after date of DPT’s invoice therefor. Invoices shall be generated upon either (i) DPT’s quality department’s release of Product or (ii) shipment of Product
from DPT; whichever occurs first. Total invoice shall be equal to the quantity of Product released times the Total Price per unit, effective on the date of Product release, as listed in Schedule A. 
  

	2.10	Late Payment 

  

	 	(a)	Late Fee 

 A late fee of one and one-half
percent (1.5%) of total invoice can be added each month for late payments. DPT, at its sole discretion, has the right to discontinue COMPANY’s credit on future orders and to put a hold on any production or shipment of Product if
COMPANY’s account is not current. Such hold on production or shipment shall not constitute a breach of this 

  

 - 12 - 

 
Agreement by DPT. In the event credit is discontinued, a one hundred percent (100%) material deposit paid by COMPANY to DPT will be required prior to
DPT ordering materials. In addition, a fifty percent (50%) Manufacturing Fee deposit will be required prior to DPT manufacturing any Product and the balance of the invoice must be paid in full prior to shipment. 
  

	 	(b)	Collateral Security 

 As collateral security
for COMPANY’s payment obligations contained in this Agreement, COMPANY grants to DPT a security interest in all raw materials, inventory, work-in-progress, and finished goods ordered or produced in connection with this Agreement. Chapter 9 of
the Texas Uniform Commercial Code shall govern the rights and obligations of the parties relative to the security interests granted herein. 
  

	2.11	Disposal Costs 

 DPT reserves the right to invoice
COMPANY for all disposal costs, related to manufacture of the Products, unless the disposal relates to a Rejected Product causes by the failure of DPT to follow established written procedures. 
 III -SHIPMENT AND RISK OF LOSS 
  

	3.1	Shipment 

 Shipment of Product shall be in
accordance with COMPANY instructions, provided that shipment is made in accordance with all relevant statutory requirements. Product will be shipped to COMPANY or its designee immediately upon release, Free on Board (FOB), DPT’s Plant of
Manufacture. At COMPANY’s request, DPT may hold Product in DPT’s warehouse for a storage fee. Product held at DPT will be subject to payment in accordance with paragraph 2.9 above. If COMPANY requests DPT to make any miscellaneous small
shipments of Product, material, or other items on COMPANY’s behalf, COMPANY agrees to reimburse DPT for any shipping charges incurred. 
  

	3.2	Delivery Terms 

 The purchase price of Products in
Schedule A hereof shall be F.O.B., DPT’s plant of manufacture, San Antonio, Texas, freight collect. COMPANY will bear all risk of loss, delay, or damage in transit, as well as cost of freight and insurance. 
  

	3.3	Claims 

 The weights, tares and tests affixed by
DPT’s invoice shall govern unless established to be incorrect. Claims relating to quantity, weight and loss or 

  

 - 13 - 

 
damage to any Product sold under this Agreement shall be waived by COMPANY unless made within thirty (30) days of receipt of Product by COMPANY.

 IV -TERM AND TERMINATION 
  

	4.1	Term 

 This Agreement shall commence on the first
day of the month following the mutual signing of this document and will continue until the expiration of the Fifth (5th) Market Year from the date the last Product added to Schedule A, unless sooner terminated pursuant to paragraph 4.2 below.
This Agreement shall thereafter automatically renew for periods of 12 months, unless any party shall give notice to the other to the contrary at least six (6) months prior to the expiration of the initial term or any renewal term of the
Agreement. 
  

	4.2	Termination 

  

	 	(a)	Breach. Either Party may terminate this Agreement at any time on written notice if the other party breaches its obligations herein, which breach is not remedied within sixty
(60) days after written notice thereof. 

  

	 	(b)	Insolvency. Either Party may terminate this Agreement immediately in its entirety if the other Party files a petition for bankruptcy, is adjudged bankrupt, takes advantage of
any insolvency statute, or executes a bill of sale, deed of trust or assignment for the benefit of creditors. 

  

	 	(c)	Failure to Supply. If DPT is unable to supply Product to meet COMPANY’s requirements for a period in excess of thirty (30) days, whether the result of a force
majeure or not, then COMPANY will have the right, upon written notice to DPT, to : 1) terminate this Agreement in its entirety; 2) discontinue purchase of Product or 3) purchase Product from an alternate source. 

  

	4.3	Payment on Termination 

 In the event of the
termination or cancellation of this Agreement for any reason, and without prejudice to any other rights and remedies available to DPT hereunder, COMPANY agrees to reimburse DPT for the Materials Fee for the manufacture of the Products based on
COMPANY’s Forecasted Needs as well as for work-in-process and finished Products. 
  

	4.4	Survival 

 Termination of this Agreement under
paragraph 4.2 or due to expiration or cancellation shall not relieve either party of obligations or liability for breaches of 

  

 - 14 - 

 
this Agreement incurred prior to or in connection with termination, expiration or cancellation. Sections VI, VII, IX, X, XI and XII hereof shall survive the
termination or cancellation of this Agreement for any reason. 
 V -CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE

  

	5.1	Certificates of Analysis 

 DPT shall test each lot
of Product purchased pursuant to this Agreement before delivery to COMPANY. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. DPT shall send one (1) Certificate of Analysis to
COMPANY at the time of the release of Product. DPT shall provide a signed Certificate of Compliance Confirming that the Products have been manufactured, tested and stored in compliance with cGMP criteria. Extraordinary reporting or documentation,
outside this Agreement, may be subject to an additional charge by DPT. 
  

	5.2	Stability Testing 

 DPT shall perform its standard
stability test program as defined in DPT’s SOP’s or as separately agreed to in accordance with a Protocol Change Request (“PCR”) for each of the Products contained herein. COMPANY shall receive a copy of DPT’s Annual Report
for each Product as long as DPT is continuing to produce such Product for COMPANY and for as long as COMPANY’s account is current. If COMPANY elects to perform its own stability testing on Product, COMPANY agrees to provide DPT with a copy of
the results from such testing on an annual basis. 
  

	5.3	Validation Work or Additional Testing 

 It is
understood by the parties hereto that the responsibility for any validation work shall be the sole responsibility of COMPANY. The parties agree that for any validation work or additional testing in connection with the Product, DPT and COMPANY shall
enter into a specific written Project Protocol establishing methodology and pricing for such services. It is understood between the parties hereto that if DPT is required by regulatory authority to perform validation studies or additional testing in
order to legitimately continue to engage in the manufacture of the Product for COMPANY and DPT and COMPANY cannot reach an agreement on a written Project Protocol, then DPT shall be under no obligation to continue the manufacture of the Product
affected by said regulation. 
  

	5.4	FDA Inspection 

 DPT shall advise COMPANY if an
authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which directly pertain to the Products. FDA audit time specific to Products will be billed to COMPANY
from DPT at the then-prevailing QA hourly rate. 
  

 - 15 - 

 DPT will notify COMPANY and upon request of the COMPANY, will provide appropriately redacted copies of
regulatory authority audits specifically pertaining to the Product(s) (e.g. FDA 483, Warning Letters, EMEA and local EU regulatory reports) to the COMPANY. 
  

	5.5	Regulatory Filings 

 COMPANY agrees to provide DPT
with copies of any sections of NDA’s, ANDA’s, 510(k)’s or other regulatory filings applicable to the Products manufactured and/or tested by DPT, and copies of any changes in or updates of same as they, from time to time, hereafter
occur. 
 DPT will endeavor to provide reasonable assistance to the COMPANY for a pre-negotiated fee with respect to providing
data/documentation required for the preparation of submissions and/or responses to regulatory authority(ies). 
 VI -WARRANTIES

  

	6.1	Conformity with Specifications 

 DPT warrants that
all Products manufactured and delivered pursuant to this Agreement will have been manufactured in accordance with the Specifications for the release of the Product or pursuant to exceptions approved in writing by COMPANY prior to the time of
manufacture and release. 
  

	6.2	Compliance with the Act 

 COMPANY shall bear sole
responsibility for the validity of all test methods provided by the Company and appropriateness of all Specifications. In addition, COMPANY shall bear sole responsibility for all regulatory approvals, filings, and registrations and adequacy of all
validation, stability, and preservative efficacy studies, provided that if any approval, filing and/or registration is required to be obtained and/or maintained by DPT for any facility where the Product is manufactured, packaged and/or shipped, DPT
shall bear sole responsibility for any such approval, filing and/or registration. COMPANY further warrants that it has obtained any and all necessary approvals from all applicable regulatory agencies necessary to manufacture and distribute all
Products under this Agreement, except for any approvals that are necessary in connection with any facility where the Product is manufactured, packaged and/or shipped for which DPT warrants that it has obtained any and all such necessary approvals
from all applicable regulatory agencies. 
  

 - 16 - 

	6.3	Conformity with FDA regulations and cGMP’s 

 Subject to the provisions set forth in paragraph 6.2 and 6.4 hereof, DPT warrants that all Products manufactured, packaged, labeled, held for sale, and/or shipped pursuant to this Agreement shall have been manufactured, packaged, labeled,
held for sale, and/or shipped by DPT in compliance with applicable FDA regulations and current Good Manufacturing Practices as that term is defined under the Act and any other applicable Texas law or FDA regulation. DPT warrants that no Product
manufactured pursuant to this Agreement shall be adulterated or misbranded under the Act and that ownership and operation of its manufacturing, Packaging, Labeling and shipping facilities shall be in compliance with current Good Manufacturing
Practices and applicable laws and FDA regulations. DPT further warrants and represents that none of its employees or representatives who will perform services pursuant to his Agreement have been debarred or are under consideration to be debarred by
the United States Food and Drug Administration from working in or providing services to any pharmaceutical or biotechnology company under the Generic Drug Enforcement Act of 1992, as amended. 
  

	6.4	Compliance of Packaging and Labeling with Laws and Regulations 

 COMPANY warrants that all Labeling copy and artwork approved, designated or supplied by COMPANY shall be in compliance with all applicable laws and governmental regulations. Compliance with all federal, state, and
local laws and regulations concerning Packaging and Labeling shall be the sole responsibility of COMPANY, provided that DPT purchases such Packaging and Labeling as provided in paragraph 2.2 (c) hereof. COMPANY hereby represents and warrants to
DPT that all COMPANY designated formulas, components and artwork related to the Product do not violate or infringe any patent, copyright or trademark laws, and agrees to indemnify DPT, its employees, officers, directors and representatives for any
claim, loss or damage including reasonable attorney’s fees paid or incurred by any of them in connection therewith. 
  

	6.5	Access to DPT’s Facilities 

 COMPANY shall have
direct access to DPT’s facilities, records and reports at mutually agreeable times for the sole purpose of auditing DPT’s compliance with current Good Manufacturing Practices and the Act. Such access shall in no way give COMPANY the right
to any of DPT’s confidential or proprietary information. Further, such audits shall normally be limited to every twelve (12) months and three (3) designees of COMPANY who are subject to substantially similar requirements of
confidentiality as COMPANY. 
  

	6.6	Disclaimer 

 DPT AND COMPANY MAKE NO OTHER
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCT, LABELING OR PACKAGING. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND 

  

 - 17 - 

 
FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED. IN NO EVENT WILL DPT BE LIABLE FOR ANY LOSS OF PROFITS, LOSS OF USE, BUSINESS INTERRUPTION,
COST OF COVER, OR INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND IN CONNECTION WITH OR ARISING OUT OF THE PERFORMANCE OF THIS AGREEMENT, WHETHER ALLEGED AS A BREACH OF CONTRACT OR TORTIOUS CONDUCT, INCLUDING NEGLIGENCE, EVEN IF
DPT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. DPT’S LIABILITY UNDER THIS AGREEMENT FOR DAMAGES OF ANY KIND, WILL NOT, IN ANY EVENT, EXCEED THE FEES PAID BY COMPANY TO DPT UNDER SECTION II OF THIS AGREEMENT. 
 VII -PRODUCT RECALLS 
 Only
COMPANY may initiate any recall action. In the event (i) any government authority issues a request, directive or order that Product be recalled, or (ii) a court of competent jurisdiction orders such a recall, or (iii) DPT reasonably
determines after consultation with COMPANY that the Product should be recalled because the Product does not conform to Specifications at the time of shipment by DPT, or (iv)COMPANY reasonably determines that the Product should be recalled for any
reason, the parties shall take all appropriate corrective actions reasonably requested by the other party hereto or by any government agency, provided, however, COMPANY shall have the final responsibility and sole discretion to implement and execute
any such recall. In the event that such recall results from the breach of DPT’s warranties under this Agreement, *** shall be responsible for the *** of the recall ***. In the event the recall results from the breach of COMPANY’s
obligations or warranties under this Agreement, COMPANY shall be responsible for the expenses of the recall. For the purposes of this Agreement, the expenses of the recall shall be the expenses of notification and destruction or return of the
recalled Product, as well as any reasonable out of pocket costs incurred by DPT and COMPANY in connection with any corrective action by DPT and COMPANY> 
 VIII -FORCE MAJEURE 
 Failure of either party to perform its obligations under this Agreement
shall not subject such party to any liability to the other if such failure is caused by acts such as, but not limited to, acts of God, fires, explosion, flood, drought, war, riot, sabotage, embargo, strikes, compliance with any court order or
regulation of any government entity acting with color of right or by any other cause beyond the reasonable control of the parties, whether or not foreseeable. 
  

 - 18 - 

 IX -CHANGES TO PROCESS OR PRODUCT 
  

	9.1	Changes by COMPANY 

 If COMPANY at any time requests
a change to Product and DPT agrees such change is reasonable with regard to Product manufacture; (i) such change shall be incorporated within the Master Batch Record and/or Specifications via a written PCR reviewed and agreed upon by both DPT
and COMPANY; (ii) The parties shall adjust the price of Product, if necessary, and Schedule A shall be amended accordingly, and (iii) COMPANY shall pay DPT for the costs associated with such change including, but not limited to, any
additional development or validation work required, charged at DPT’s then-prevailing R&D rates in accordance with Section XI contained herein. 
  

	9.2	Changes by DPT 

 DPT agrees that any changes
developed by DPT, which may be incorporated into the Product shall require the written approval of COMPANY via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications. It is also
agreed that any regulatory filings incident to any such change shall be the sole responsibility of COMPANY. 
  

	9.3	Changes by Regulatory Authorities 

 The parties
agree that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of COMPANY via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part
of the Specifications. If DPT is required by regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new material and finished Product assay procedures with respect to Product
in order to continue to engage in the manufacture of said Product for COMPANY, such studies shall be conducted in accordance with paragraph 5.3 herein. Any costs to DPT resulting from the operation of this paragraph shall be reimbursed by COMPANY.

  

	9.4	Obsolete Inventory 

 Any COMPANY-specific inventory
including, but not limited to, materials, work-in-process, and Products rendered obsolete as a result of formula, artwork or packaging changes requested by COMPANY or by changes required by regulatory authority shall be reimbursed to DPT by COMPANY
at DPT’s Materials Fee. At such time and unless otherwise agreed by DPT, DPT will ship the obsolete inventory to COMPANY for destruction by COMPANY. COMPANY shall bear one hundred percent (100%) of all shipping and destruction costs
related to said obsolete inventory. The destruction shall be in accordance with all applicable laws and regulations and COMPANY shall indemnify DPT for any liability, costs or expenses, including attorney’s fees and court costs, relating to
COMPANY’s failure to dispose of such inventory in accordance with such laws and regulations. COMPANY shall also provide DPT with all manifests and other 

  

 - 19 - 

 
applicable evidence of proper destruction as may be requested by DPT or required by applicable law. If DPT does not receive disposition instructions from
COMPANY within ninety (90) days from date of obsolescence, obsolete inventory remaining at DPT’s facilities shall be subject to storage fees. 
 X -CONFIDENTIAL INFORMATION: INTELLECTUAL PROPERTY RIGHTS 
  

	10.1	Confidential Information 

  

	 	(a)	Obligations of Confidentiality 

 All
confidential information furnished by COMPANY to DPT, or by DPT to COMPANY, during the term of this Agreement, relating to the subject matter hereof, shall be kept confidential by the party receiving said confidential information, except for
purposes authorized by this Agreement, and shall not be disclosed to any person or firm, unless previously authorized in writing to do so, for a period of not less than five (5) years following the date of disclosure. The party receiving said
confidential information may, however, disclose the same to its responsible officers and employees who require said information for the purposes contemplated by this Agreement, provided that said officers and employees shall have assumed like
obligations of confidentiality. It is understood that all confidential information provided by either party shall be identified or marked as such. Any oral communications which are to be considered confidential shall be reduced to writing and
identified as confidential within thirty (30) days after disclosure. 
  

	 	(b)	Exceptions 

 Any other provisions hereof to
the contrary notwithstanding, it is expressly understood and agreed by the parties hereto that the obligations of confidence and nonuse herein assumed shall not apply to any information which: 
  

	 	(1)	is at the time of disclosure or thereafter so becomes a part of the public domain; or 

  

	 	(2)	was otherwise in the receiving party’s lawful possession prior to disclosure as shown by its written record; or 

  

	 	(3)	is hereafter disclosed to the receiving party by a third party purporting not to be in violation of an obligation of confidentiality to the disclosing party relative to said
information; or 

  

	 	(4)	is by mutual agreement of the parties hereto released from a confidential status; or 

  

 - 20 - 

	 	(5)	is required to be disclosed pursuant to regulatory or legal requirements. 

  

	 	(c)	Competing Products 

 It is understood and
agreed that DPT manufactures products for itself and third parties, some of which may be substantially equivalent to and in competition with Products of COMPANY. 
  

	10.2	Trademarks and Trade Names 

  

	 	(a)	Each party hereby acknowledges that it does not have, and shall not acquire any interest in any of the other party’s trademarks or trade names unless otherwise expressly
agreed. 

  

	 	(b)	Each party agrees not to use any trade names or trademarks of the other party, except as specifically authorized by the other party in writing both as to the names or marks which
may be used and as to the manner and prominence of use. 

 XI -RESEARCH & DEVELOPMENT SERVICES

 PURPOSELY DELETED 
 XII -INDEMNIFICATION 
  

	12.1	Indemnification by DPT 

 Subject to paragraph 6.6
above, DPT will indemnify and hold COMPANY, its officers, agents and employees harmless against any and all liability, damage, fine, judgment, loss, cost, or expense (including attorney’s fees) resulting from any third party claims made or
suits brought against COMPANY which arise from DPT’s breach of its warranties set forth in Section VI hereof, provided such sum does not exceed available insurance coverage. 
  

	12.2	Indemnification by COMPANY 

 COMPANY will indemnify
and hold DPT harmless against any and all liability, damage, loss, cost or expense (including reasonable attorney’s fees) resulting from any third party claims made or suits brought against DPT which are related to the breach of any of
COMPANY’s warranties provided for herein or which arise out of the promotion, distribution, use, testing or sales of Products, including, without limitation, any claims, express, implied or statutory, made as to the efficacy, safety, or use to
be made of Products, and claims made by reason of any Product Labeling or any Packaging containing Product (provided such 

  

 - 21 - 

 
packaging and Labeling was purchased by DPT as provided in paragraph 2.2 (c) hereof), unless such liability, damage, loss or expense is caused by the
breach of DPT’s warranties under Section VI hereof. 
  

	12.3	Patent and Other Intellectual Property Rights 

  

	 	(a)	Warranty by COMPANY 

 COMPANY warrants that
manufacture of Products or sales of Products will not infringe any patent or other proprietary rights and that COMPANY will indemnify, defend and hold DPT harmless from any damage, judgment, loss, cost or other reasonable expense (including
reasonable attorney’s fees) arising from claims that Products or the use of the Product names and any other trademarks, trade names, or trade dress used by COMPANY in connection with Products infringes patent or other proprietary rights of a
third party. 
  

	 	(b)	Indemnification by DPT 

 DPT shall indemnify
and hold COMPANY harmless from all costs, damages and expense (including reasonable attorney’s fees) arising out of any suit or action brought against COMPANY based upon a claim that any process or technical data furnished or utilized by DPT
infringes any patent or other proprietary rights. 
  

	12.4	Conditions of Indemnification 

 If either party
expects to seek indemnification from the other under paragraphs 12.1, 12.2, or 12.3 hereof, it shall promptly give notice to the other party of any such claim or suit threatened, made or filed against it which forms the basis for such claim of
indemnification and shall cooperate fully with the other party in the defense of all such claims or suits. No settlement or compromise shall be binding on a party hereto without its prior written consent. 
  

	12.5	Evidence of Liability Insurance 

 It is further
agreed that each party hereto shall furnish to the other evidence of products and contractual liability insurance coverage affording not less than two million dollars ($2,000,000) each occurrence combined single limit, bodily injury/property damage
and two million dollars ($2,000,000) aggregate liability limits. Each insurer shall name the other as an additional insured. Such evidence of insurance coverage can be in the form of the original policy or Certificate of Insurance which shall
provide that the insurer has assumed the liability as provided for herein. In addition, such insurers shall warrant that such insurance will not be changed or canceled without at least thirty (30) days prior written notice to the respective
indemnities. 
  

 - 22 - 

 XIII -GENERAL PROVISIONS 
  

	13.1	Notices 

 Any notices permitted or required by this
Agreement shall be sent by certified or registered mail with a copy by fax and shall be effective the earlier of the date received or three (3) days after deposit in the U.S. mail, if sent and addressed as follows or to such other address as
may be designated by either party in writing: 
  

			
	If to DPT:	  	DPT Laboratories, Ltd.
		  	Attention: President
		  	P.O. Box 1659
		  	San Antonio, Texas 78296
		  	Fax: (210) 227-6132
		  	with a copy to the General Counsel’s Office
		
	If to COMPANY:	  	Barrier Therapeutics, Inc.
		  	Attention: President
		  	600 College Road East
		  	Princeton, New Jersey 08540
		  	Fax: (609) 375-2660

  

	13.2	Entire Agreement; Amendment 

 The parties hereto
acknowledge that this document sets forth the entire agreement and understanding of the parties and supersedes all prior written or oral agreements or understandings with respect to the subject matter hereof, and shall supersede any conflicting
portions of DPT’s quotation, acknowledgment and invoice forms and COMPANY’s Purchase Order and other written forms. No modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to be valid unless in
writing and signed by the party against whom enforcement is sought. No course of dealing or usage of trade shall be used to modify the terms and conditions herein. 
  

	13.3	Waiver 

 No waiver by either party of any default
shall be effective unless in writing, nor shall any such waiver operate as a waiver of any other default or of the same default on a future occasion. 
  

 - 23 - 

	13.4	Obligations to Third Parties 

 Each party warrants
and represents that proceeding herein is not inconsistent with any contractual obligations, express or implied, undertaken with any third party. 
  

	13.5	Assignment 

 This Agreement shall be binding upon
and inure to the benefit of the successors or permitted assigns of each of the parties and may not be assigned or transferred by either party without the prior written consent of the other, which consent will not be unreasonably withheld, except
that such consent shall not be required in connection with a merger or acquisition of a substantial portion of the assets of either party by a third party and provided that the successor or assignee assumes all obligations imposed herein. Any
assignments, including but not limited to, sale, transfer, or license of brand or Products, shall not release the original party hereto from their duties and obligations under this Agreement. 
  

	13.6	Governing Law 

  

	 	(a)	Governing Law 

 The validity, interpretation
and effect of this Agreement shall be governed by and construed under the laws of the State of New Jersey. 
  

	 	(b)	Arbitration 

  

	 	(i)	ANY DISPUTE, CLAIM OR CONTROVERSY ARISING FROM OR RELATED IN ANY WAY TO THIS AGREEMENT OR THE INTERPRETATION, APPLICATION, BREACH, TERMINATION OR VALIDITY THEREOF, INCLUDING ANY
CLAIM OF INDUCEMENT OF THIS AGREEMENT BY FRAUD OR OTHERWISE, WILL BE SUBMITTED FOR RESOLUTION TO ARBITRATION PURSUANT TO THE COMMERCIAL ARBITRATION RULES THEN PERTAINING OF THE CENTER FOR PUBLIC RESOURCES (“CPR”), EXCEPT WHERE THOSE RULES
CONFLICT WITH THESE PROVISIONS, IN WHICH CASE THESE PROVISIONS CONTROL. SUCH ARBITRATION SHALL BE HELD IN (I) COMPANY’S HOME COUNTY, IF THE DEMAND FOR ARBITRATION IS INITIATED BY DPT OR (II) OCEAN COUNTY, NEW JERSEY, IF THE DEMAND FOR
ARBITRATION IS INITIATED BY COMPANY. 

  

	 	(ii)	 The panel shall consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals each of whom is a lawyer specializing in business litigation with
at least 15 years experience with a law firm of over 25 lawyers or was a judge of a court of general jurisdiction. In the event the aggregate damages sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by
the counterclaimant are stated to be 

  

 - 24 - 

	 	 
less than $5 million, and neither side seeks equitable relief, then a single arbitrator shall be chosen, having the same qualifications and experience
specified above. 

  

	 	(iii)	The parties agree to cooperate: (1) to obtain selection of the arbitrator(s) within 30 days of initiation of the arbitration, (2) to meet with the arbitrator(s) within 30
days of selection and (3) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which will result in the hearing being concluded within no more than 9 months after selection of the arbitrator(s)
and in the award being rendered within 60 days of the conclusion of the hearings, or of any post-hearing briefing, which briefing will be completed by both sides within 20 days after the conclusion of the hearings In the event no such agreement is
reached, the CPR will select arbitrator(s), allowing appropriate strikes for reasons of conflict or other cause and three peremptory challenges for each side. The arbitrator(s) shall set a date for the hearing, commit to the rendering of the award
within 60 days of the conclusion of the evidence at the hearing, or of any post-hearing briefing (which briefing will be completed by both sides in no more than 20 days after the conclusion of the hearings), and provide for discovery according to
these time limits, giving recognition to the understanding of the parties hereto that they contemplate reasonable discovery, including document demands and depositions, but that such discovery be limited so that the time limits specified herein may
be met without undue difficulty. In no event will the arbitrator(s) allow either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses. In the event multiple hearing days
are required, they will be scheduled consecutively to the greatest extent possible. 

  

	 	(iv)	The arbitrator(s) shall render an opinion setting forth findings of fact and conclusions of law with the reasons therefor stated. A transcript of the evidence adduced at the hearing
shall be made and shall, upon request, be made available to either party. 

  

	 	(v)	To the extent possible, the arbitration hearings and award will be maintained in confidence. 

  

	 	(vi)	 Any court of competent jurisdiction may enter judgment upon any award. In the event the panel’s award exceeds $5 million in monetary damages or includes or
consists of equitable relief, then the court shall vacate, modify or correct any award where the arbitrators’ findings of fact are clearly erroneous, and/or where the arbitrators’ conclusions of law are erroneous; in other words, it will
undertake the same review as if it were a federal appellate court 

  

 - 25 - 

	 	 
reviewing a district court’s findings of fact and conclusions of law rendered after a bench trial. An award for less than $5 million in damages and not
including equitable relief may be vacated, modified or corrected only upon the grounds specified in the Federal Arbitration Act. 

  

	 	(vii)	Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin,
etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration. 

  

	 	(viii)	EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY. 

  

	 	(c)	Costs 

 The costs of arbitration, including
reasonable attorney’s fees, shall be borne by the losing party. 
  

	13.7	Severability 

 In the event that any term or
provision of this Agreement shall violate any applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or otherwise be unenforceable, such provision shall be ineffective to the extent of such violation without
invalidating any other provision hereof. 
  

	13.8	Headings, Interpretation 

 The headings used in this
Agreement are for convenience only and are not a part of this Agreement. 
  

	13.9	Counterparts 

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

	13.10	Independent Contractor 

 In performing its services
hereunder, DPT shall act as an independent contractor. 
 IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be
executed by their duly authorized officers as of the date first above written. 
  

 - 26 - 

											
	BARRIER THERAPEUTICS, INC.	 	DPT LABORATORIES, LTD.
				
	By:	 	 /s/ A. Altomari
	 	By:	 	 /s/ Paul Johnson

	Title: COO	 	  
	 	Title: President & COO	 	  

  

 - 27 - 

 SCHEDULE A - 2005 
 Barrier Therapeutics, Inc 
  

											
	 PRODUCT NUMBER
	  	 PRODUCT DESCRIPTION
	  	ESTIMATED
ANNUAL
VOLUME	  	MFG. PRICE	  	MATERIAL
PRICE	  	TOTAL PRICE
	 TBD
	  	Ketaconazole 2% 15 gram tubes	  	***	  	***	  	***	  	***
						
		  		  	***	  		  		  	

	1)	Manufacturing and Materials fee’s are based on annual volumes listed above 

	2)	Substantial changes from the above annual volume may effect Manufacturing and/or Materials fees 

	3)	Effective date for above Fees is January 1, 2006 through Dec. 31, 2006 

	4)	Shipped from San Antonio, TX 

	5)	Manufacture of bulk product and filling into metal tubes 

	6)	QA and Micro testing included 

 Initials/Date Barrier Therapeutics, Inc.:
/s/
AA                                        

 Initials/Date DPT Laboratories: /s/
PJ

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