Document:

Amended and Restated License and Supply Agreement

 Exhibit 10.33 
 AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT 
 “DOVONEX® AGREEMENT” 
 between 
 WARNER CHILCOTT COMPANY, INC. 
 and 
 LEO Pharma A/S 
  

			
	 DOVONEX® AGREEMENT
	 	

 TABLE OF CONTENTS 
  

					
	I	 	DEFINITIONS	  	4
			
	II	 	RIGHTS	  	8
			
	III	 	SUPPLY OF FINISHED PRODUCTS	  	10
			
	IV	 	MARKETING	  	20
			
	V	 	ACCOUNTING AND ROYALTY PAYMENT	  	22
			
	VI	 	PATENT PROTECTION AND VALIDITY	  	23
			
	VII	 	THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS	  	24
			
	VIII	 	CONFIDENTIALITY	  	25
			
	IX	 	REGISTRATIONS	  	25
			
	X	 	TRADEMARKS	  	26
			
	XI	 	AUTHORISATIONS	  	27
			
	XII	 	QUALITY ASSURANCES	  	27
			
	XIII	 	SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL	  	28
			
	XIV	 	RESPONSIBILITIES OF PARTIES	  	28
			
	XV	 	TERM AND TERMINATION; CONSEQUENCES OF TERMINATION	  	30
			
	XVI	 	ASSIGNABILITY	  	32
			
	XVII	 	AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY	  	33
			
	XVIII	 	STATUS OF PRIOR AGREEMENT	  	34
			
	XIX	 	FORCE MAJEURE	  	34
			
	XX	 	NON-COMPETITION CLAUSE	  	35
			
	XXI	 	PARTNERSHIP/AGENCY; THIRD PARTIES	  	35
			
	XXII	 	GOVERNING LAW	  	35
			
	XXIII	 	NOTICES	  	36

 Appendices: 
  

			
	Appendix I:	  	Products
		
	Appendix II:	  	LEO Logo Guidelines
		
	Appendix III:	  	LEO Product Concept
		
	Appendix IV:	  	Patents
		
	Appendix V:	  	Batch Size and Minimum Order Quantity Per Delivery
		
	Appendix VI:	  	Quality Agreement
		
	Appendix VII:	  	WCCI’s Pharmaceutical Import License
		
	Appendix VIII:	  	Pharmacovigilance Agreement
		
	Appendix IX:	  	Complaints and Product Recall

  

			
	 DOVONEX® AGREEMENT
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 AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT 
 between 
 WARNER CHILCOTT COMPANY, INC. of P.O. Box
1005, Fajardo, Puerto Rico, 00738 (“WCCI”) 
 and 
 LEO Pharma A/S of Industriparken 55, DK-2750 Ballerup, Denmark (“LEO”). 
 Capitalized terms not otherwise defined herein shall have the meanings set forth in Article I of this Agreement. 
 WHEREAS, LEO has discovered and developed the Compound and Manufactures pharmaceutical products containing the Compound for human therapeutic use; 
 WHEREAS, WCCI has marketing expertise within the field of dermatology; 
 WHEREAS, WCCI and LEO are interested in collaborating on the marketing of the Compound in the Territory; 
 WHEREAS, LEO and GALEN (Chemicals) Limited (“GALEN”) entered into a License and Supply Agreement dated as of April 1, 2003 relating to the Compound
(the “Original Agreement”); 
 WHEREAS, GALEN has assigned its rights and obligations under the Original
Agreement to WCCI, an Affiliate of GALEN; and 
 WHEREAS, LEO and WCCI desire to amend and restate the Original
Agreement as set forth below. 
  

			
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 NOW THEREFORE, the Parties hereby agree as follows: 
 I - DEFINITIONS 
  

	1.1	“Action or Proceeding” shall mean any action, suit, proceeding, arbitration or Governmental or Regulatory Authority action, notification, investigation or audit.

  

	1.2	“Affiliate” shall mean, with respect to any Person, any Person which, directly or indirectly, controls, is controlled by, or is under common control with, the
specified Person. For purposes of this definition, the term “control” as applied to any Person, means the possession, directly or indirectly, of at least fifty-one per cent (51%) of the power to direct or cause the direction of the
management of that Person, whether through ownership of voting securities or otherwise. 

  

	1.3	“Agreement” shall mean this Amended and Restated License and Supply Agreement between WCCI and LEO. 

  

	1.4	“BMS” shall mean Bristol-Myers Squibb Company. 

  

	1.5	“BMS Agreements” shall mean the agreement dated September 28, 1989 between BMS (as successor to E.R. Squibb & Sons Inc.) and LEO, as amended
July 6, 1992, April 8, 1993 and as of April 1, 2003 and the Product Supply Agreement between BMS and LEO dated as of April 8, 1993, each as may be amended or supplemented by the parties in the future.

  

	1.6	“Combination Product” shall mean the pharmaceutical formulations containing both the Compound and Betamethasone Dipropionate in an ointment.

  

	1.7	“Compound” shall mean the compound Calcipotriene, a vitamin D analogue with the formula C27H4003. 

  

	1.8	“Confidentiality Agreement” shall mean the Confidentiality Agreement dated as of 4 July 2005 between the Parties. 

  

	1.9	“current Good Manufacturing Practices” shall mean the regulatory and other standards of good manufacturing practice in the Territory, as in effect from time to
time, relating to the Manufacture of medicinal products. 

  

			
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	1.10	“DC Agreement” shall mean the License, Supply and Development Agreement dated as of the date hereof between LEO and WCCI. 

  

	1.11	“Effective Date” shall mean the date on which this Agreement becomes effective pursuant to Article 3.4(b) of the Master Agreement. 

  

	1.12	“FDA” shall mean the United States Food and Drug Administration. 

  

	1.13	“Finished Product” shall mean the Products which are ready for sale to customers in finished, final packaged form. 

  

	1.14	“Governmental or Regulatory Authority” shall mean any court, tribunal, arbitrator, agency, commission, official or other instrumentality of the United States or any
relevant country, state, province, county, city or other political subdivision. 

  

	1.15	“Gross Margin” shall mean Net Sales less an amount equal to a percentage of Net Sales determined by adding the purchase price, as set forth in Article 3.2
and the applicable royalty rate, set forth in Article 5.1. 

  

	1.16	“IND” shall mean the Investigational New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act and applicable regulations
promulgated thereunder as amended from time to time, filed in the United States for the Product. 

  

	1.17	“Laws” shall mean all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any relevant Governmental or Regulatory
Authority. 

  

	1.18	“LEO Logo Guidelines” shall mean the guidelines for use of the LEO name and the Assyrian Lion logo, as amended from time to time, Appendix II.

  

	1.19	“LEO Product Branding” shall mean the Trademark, the LEO name, the Assyrian Lion, the LEO Logo Guidelines, the LEO Product Concept, and any domain names or websites
related to the Product in the Territory. 

  

			
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	1.20	“LEO Product Concept” shall mean the global concept for packaging and promotional materials related to the Products developed by LEO, as amended from time to time,
Appendix III. 

  

	1.21	“Losses” shall mean any and all damages, fines, fees, penalties, deficiencies, losses and expenses (including without limitation interest, court costs, reasonable
fees of attorneys, accountants and other experts or other expenses of litigation or other proceedings or of any claim, default or assessment). 

  

	1.22	“Manufacture” shall mean all the activities relating to production of each Product, spanning from purchasing raw materials to packaging Product including, but not
limited to, purchasing raw materials, packaging materials, production, quality control and assurance, filling, labelling, packaging and finishing, release, holding and storage and the tests and analyses conducted in connection therewith.

  

	1.23	“Manufacturing Authorization” shall mean the authorization to Manufacture the Products as granted by the relevant Governmental or Regulatory Authorities.

  

	1.24	“Master Agreement” shall mean the Master Agreement dated as of 1 April 2003 between LEO and WCCI (as assignee of GALEN), as amended by Addendum I dated as of
the date hereof between LEO and WCCI (“Addendum I to the Master Agreement”), as further amended from time to time. 

  

	1.25	“NDA” shall mean the New Drug Application filed with the FDA for a Product, requesting permission to place a Product on the market in accordance with 21 C.F.R. Part
314 and all supplements filed pursuant to the requirements of the FDA, including all documents, data and other information concerning such Product which are necessary for FDA approval to market a product in the United States.

  

	1.26	“Net Sales” shall mean the adjusted gross invoice price, the adjusted gross invoice price being the aggregate sales of WCCI and its Affiliates of the Product to
unaffiliated third parties in the Territory (but not including sales between WCCI and its Affiliates) less sales returns and allowances, including trade, quantity and cash discounts and any other adjustments, including those granted on account of
price adjustments, billing errors, rejected goods, damaged goods, Recalls, returns, rebates, chargeback rebates, fees, reimbursements or similar payments granted or given to wholesalers or other distributors (including retailers), buying groups,

  

			
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 health care insurance carriers or other institutions, freight and insurance charges billed to the
customers, customs or excise duties, sales tax and other taxes (except income taxes) or duties relating to sales, and any payment in respect of sales to any Governmental or Regulatory Authority in respect of any Federal or state Medicaid, Medicare
or similar program, all as determined in accordance with generally accepted accounting principles on a basis consistent with WCCI’s audited financial statements, provided, however, that the deductions from aggregate sales described above shall
in no event exceed eight percent (8%) of the gross adjusted price. 
  

	1.27	“Party” shall mean WCCI or LEO, as the case may be, and “Parties” shall mean WCCI and LEO. 

  

	1.28	“Patents” shall mean the patents and patent applications owned and controlled by LEO and listed in Appendix IV hereto, together with any reissues,
extensions, substitutions, confirmations, registrations, revalidations, additions, divisions, continuations, or continuations-in-part, of or to the aforesaid patents and patent applications and/or any patents issuing thereon, and any other patents
owned by, or licensed to LEO in the Territory which, in the absence of a license, would be infringed by the Manufacture, use, sale, offer for sale, import, storage or distribution of Products. 

  

	1.29	“Person” shall mean any individual, firm, corporation, partnership, limited liability company, trust, joint venture, Governmental or Regulatory Authority or other
entity or organization. 

  

	1.30	“Product” or “Products” shall mean the products listed in Appendix I. 

  

	1.31	“Registrations” shall mean the authorization to sell the Products in the Territory as granted by the FDA or other relevant Governmental or Regulatory Authority.

  

	1.32	“Specifications” shall mean the specifications and procedures for Manufacturing the Product as contained in the Registration for the Product and any additional
specifications as are mutually agreed upon by the parties hereto in writing, including all stability requirements set forth therein. 

  

			
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	1.33	“Technical Information” shall mean all information in the possession of LEO and/or its Affiliates, and the information transferred from BMS to WCCI, regarding
preclinical, chemical-pharmaceutical and clinical data or other scientific information (including Specifications, master batch records, analytical methods including validation protocol and the drug master file), or secret know-how about the Products
including, but not limited to marketing know-how and show-how or uses for the Product in the possession of LEO regarding the Product necessary for WCCI to fulfil its obligations under the Agreement. 

  

	1.34	“Territory” shall mean the fifty (50) states of the United States of America, the District of Columbia, its territories and current possessions.

  

	1.35	“Trademark” shall mean the trademark Dovonex® owned by LEO. 

  

	1.36	“WCCI Information” shall mean any information (including, but not limited to, technical improvements, financial and marketing information) developed, made and/or
generated by WCCI relating to and made as a result of its work with the Products. 

 II - RIGHTS 
  

	2.1	Grant. LEO hereby grants WCCI, and WCCI accepts from LEO, subject to the terms, conditions and provisions of this Agreement, an exclusive license subject to Article
4.1, with the right to sublicense to WCCI’s Affiliates, under the Trademark, Patents and Technical Information owned by, or licensed to, LEO to import, store, distribute, use, sell and offer to sell the Products in the Territory.

 The Parties acknowledge that in connection with WCCI’s efforts to market and sell the Products in the Territory, it is
necessary for WCCI to establish Internet websites with domain names containing the word “dovonex” or other Trademarks (collectively, the “Product Websites”). As promptly as practicable following the execution of this
Agreement, the Parties shall cooperate to develop a mutually acceptable strategy with respect to establishing the Product Websites including, without limitation, the negotiation and execution of mutually acceptable domain name license agreements if
necessary to effectuate such strategy. 
  

			
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	2.2	WCCI acknowledges that the FDA has required carcinogenicity studies, which started November 2001. If the studies are still running when this Agreement becomes effective WCCI agrees
to pay fifty percent (50%) of the documented expenses for these studies for which LEO is responsible incurred after the date hereof. The estimated costs and timelines are described below. 

 BMS-181161 (Calcipotriene): 2-year dermal carcinogenicity study in mice. 
  

			
	CRO:	  	Huntingdon Life Sciences, NJ, USA.
		
	Fee:	  	USD 1,128,200
		
	Start:	  	November 2001
		
	Audited draft report:	  	September 2004
		
	Remarks:	  	BMS will monitor study, incl. GLP compliance inspections. LEO will provide test article and do analytical work (TK plasma concentration analysis and test article reanalysis)

 BMS-181161 (Calcipotriene) Solution: 12-Month photocarcinogenesis study with ultraviolet
radiation in hairless mice. 
  

			
	CRO:	  	Argus Research, PA, USA (Charles River Laboratories Discovery and Development Services).
		
	Fee:	  	USD 791,000
		
	Start:	  	November 2001
		
	Audited draft report:	  	March 2003
		
	Remarks:	  	BMS will monitor study, incl. GLP compliance inspections. LEO will provide test article and do analytical work (test article reanalysis)

  

	2.3	LEO shall disclose to WCCI full details of all work undertaken in connection with the carcinogenicity studies. LEO shall provide to WCCI written progress reports at intervals of not
more than three (3) months. Meetings between LEO and WCCI shall be held at least two (2) times per year in order to review the progress of the studies and to determine further courses of action, as necessary. 

  

	2.4	LEO, its Affiliates and its partners having rights to the Products outside of the Territory (“Product Licensees”) will be free to use WCCI Information (other than
confidential financial information regarding WCCI), but shall be subject to the same confidentiality obligations set forth in Article VIII. 

  

			
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 III - SUPPLY OF FINISHED PRODUCTS 
  

	3.1	Supply. In order to ensure the quality of the Products to be sold by WCCI, WCCI shall purchase from LEO, and LEO shall supply to WCCI, according to supply conditions as set
forth in this Agreement, either from LEO or from such other sources as LEO shall authorise subject to Article 3.9.1(b), WCCI’s total requirements of the Products for use and sale for the term of this Agreement. 

 

	3.2	Purchase Price. The purchase price will be twenty percent (20%) calculated on the Net Sales of Product sold by WCCI or its Affiliates in the Territory. It is understood
that LEO has no obligation to deliver Products at a floor price below four (4) times the LEO group variable cost at all times (raw materials, packaging materials including art work, energy, labour etc.) of the manufacture of the Products.

  

	3.3	Invoicing. LEO shall issue an invoice with each shipment of Products pursuant to this Agreement and WCCI agrees to pay such invoice in immediately available funds within end
of month + thirty (30) days from the date of invoice. Invoicing and payments for Products shall be denominated in United States Dollars. Payment shall be made to an account designated by LEO in writing. The supply price of Products reflects
shipping terms of FCA [Site of Production] (ICC Incoterms 2000). 

 3.3.1 Invoice Adjustments. Because the Purchase Price
is based on Net Sales and will not be known precisely at the time of shipment of Products by LEO, such invoice price shall reflect an estimated Purchase Price agreed by the Parties. 
 Each year on 1 August (and as promptly as practicable after the date hereof with respect to 2006), the Parties shall mutually agree on an invoice
price for the following calendar year based on the expected Net Sales and on 1 January the invoice price of the stock of Products at WCCI will be adjusted to the new invoice price agreed for that new year. 
 Adjustments to correct the invoiced amount shall be made quarterly following receipt of information on the actual Net Sales realized on the sale of
Products during the applicable period. 
  

			
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 WCCI shall render to LEO, within sixty (60) days after the end of each calendar quarter, a detailed
report setting forth Net Sales for the preceding calendar quarter, the corresponding units by SKU represented by such Net Sales, the manner in which Net Sales have been calculated, as well as a calculation of said adjustments to invoice prices.
Settlement is to take place at the time of delivery of the report. 
 Any payment made by WCCI hereunder after the date such payment is due,
shall bear interest at the lesser of: (a) one and one half percent (1.5%) per month or (b) the maximum rate permitted by applicable Law. The interest on late payments shall be calculated from the date payment was due until such
payment is received by LEO. 
 The provisions set forth in this Article 3.3 that are necessary to perform the adjustments described
herein following the termination or expiration of this Agreement shall survive such termination or expiration. 
  

	3.4	Forecasts/Firm Orders. 

 (a) On the Effective Date,
WCCI will provide LEO with a firm order for the period from the Effective Date up to and including the end of the fourth full month following the Effective Date. LEO will supply the quantities set forth in such firm order in accordance with the
delivery schedule set forth therein, and to the extent such firm order is not sufficient to meet WCCI’s actual requirements of the Product for such period, LEO will use commercially reasonable efforts to supply WCCI with its requirements beyond
the amounts specified in such firm order. It is understood that quantities supplied by LEO pursuant to the firm order delivered on the Effective Date will bear the trademarks and trade dress of the Product as marketed by BMS. WCCI represents and
warrants to LEO that it has a limited license from BMS pursuant to the terms of that certain Asset Purchase Agreement between WCCI and BMS, pursuant to which WCCI acquired rights to the Product, to sell Product bearing the trademarks and trade dress
of the Product as marketed by BMS for up to six months. WCCI understands and acknowledges that the lead time for shipment of Products following the receipt of such firm orders will be three (3) months. Notwithstanding the foregoing, LEO agrees
that to the extent that BMS has placed firm orders for Product with LEO within the four months prior to the Effective Date, delivery of those orders scheduled for after the Effective Date will be based upon the lead times and the delivery dates set
forth in the forecasts delivered by BMS pursuant to the BMS Agreements. 
  

			
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 On the Effective Date, WCCI shall provide to LEO final specifications for the revised labelling and
packaging of each presentation of the Product identifying LEO as the manufacturer of the Product and WCCI as the distributor thereof, including all necessary photo-ready art (or its substantial equivalent) reflecting such modification. WCCI
understands and acknowledges that the lead time for the first shipment of Product following the receipt of such final specifications shall be four (4) months. 
 For periods thereafter, firm orders shall be filled by LEO in accordance with the firm orders placed by WCCI pursuant to Article 3.4(b). 
 (b) LEO will within five (5) working days following the end of each calendar month receive from WCCI a rolling forecast covering twenty four
(24) months of which the first four (4) months must be covered by firm orders (consisting of the then current month and the following three (3) months). LEO shall, to the best of its ability, supply to WCCI the exact amount of
Finished Products that WCCI has ordered. WCCI accepts that a variation in deliveries of +/- ten percent (10%) may occur. If LEO does not deliver Finished Products at the delivery dates stated in the respective firm order for technical reasons,
LEO shall immediately inform WCCI. Both Parties will agree to a postponement or cancellation of the firm order affected. In the event of a postponement, LEO shall deliver within four weeks of the original delivery date. If LEO does not deliver
Finished Products at the delivery dates stated in the respective firm order (or at a date otherwise agreed upon with WCCI) for any reason other than technical reasons, LEO shall deliver within four weeks of the original delivery date. Subject to
timely supply by LEO pursuant to Article 3.4(b), WCCI shall maintain at least two (2) months’ inventory of the Product (two (2) month’s inventory of each stock keeping unit (SKU)). 
 If this Agreement is terminated, and such termination results from the breach of WCCI, then any amounts owed by WCCI to LEO in respect of firm orders as
of the date of termination must be paid by WCCI. 
  

			
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 (c) The batch-size and minimum order quantity per delivery shall be as set forth in Appendix V
hereto. 
  

	3.5	Delivery. All shipments shall be shipped to such named place as WCCI shall with reasonable notice designate in writing, and will be in accordance with the delivery
instructions and with the specifications for shipping and packing included with each purchase order. Delivery will be made by LEO to a common carrier as WCCI shall direct or to any special carrier which WCCI shall designate, along with a certificate
of compliance and analysis in accordance with Article 3.9.12. All risk of loss, delay or damage in transit after delivery to such carrier shall be borne by WCCI. WCCI shall pay freight and insurance on all such shipments and all customs
brokers’ fees. 

  

	3.6	Controlling Provisions. In ordering and delivering, WCCI and LEO may employ their standard forms, but nothing in those forms shall be construed to modify or amend the terms
of this Agreement and in case of conflict herewith, this Agreement shall control. 

  

	3.7	Acceptance of Shipments. 

 3.7.1 Initial
Acceptance. After receipt of a Product shipment, WCCI shall, within thirty (30) days, visually inspect the Product shipment and communicate acceptance or rejection to LEO in writing. The Parties agree that WCCI’s visual inspection
consists of (i) comparing the applicable order against the documentation accompanying the shipment to verify that the delivery date, identity, quantity and exterior shipment labelling comply with the order and (ii) visually inspecting the
exterior of the Product shipment to verify that the shipment appears to be in good condition. 
 3.7.2 Return and Replacement. Any
quantities of the Products that are rejected and/or returned by WCCI in accordance with this Agreement and the rejection has been accepted by LEO shall be returned to LEO at the expense of LEO and at WCCI’s option (a) shall be replaced by
LEO as quickly as possible at its sole expense and the payment in respect of such quantities postponed until such replacement quantities are received and accepted by WCCI or (b) LEO shall refund any amounts paid in respect of such quantities to
WCCI. 
  

			
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 3.7.3 Independent Verification. If LEO does not agree to the rejection of the Product the Parties
will seek the opinion of an independent laboratory reasonably acceptable to both Parties, whose opinion shall be final and binding. The expenses for such expert opinion shall be borne by the Party shown to be wrong, or, if the expert cannot identify
the responsible Party, then the Parties shall share equally the expenses connected with the expert and the expenses connected with the Products rejected and/or returned. 
  

	3.8	Representations, Warranties and Covenants of WCCI. WCCI hereby represents, warrants and covenants to LEO as follows: 

 3.8.1 Packaging Components. Subject to Article 3.9.8, WCCI shall provide LEO with all artwork or other material developed or produced by
WCCI for product labels, product inserts and other printed packaging material. WCCI shall be responsible for ensuring that Product labels and Product inserts that it provides pursuant to Article 3.9.8, and any other printed materials it
provides, comply with all applicable Laws and with conditions set forth in the Registration. LEO has the right to purchase packaging components for six (6) months’ use based on the forecasts delivered at the time when LEO purchases and
WCCI shall reimburse LEO for costs involved in connection with discarded components due to changes wanted by WCCI in such components. The same applies if sale of a package size is discontinued, including, but not limited to, in case of termination
of this Agreement by LEO due to a breach by WCCI, but excluding discontinuation or withdrawal in the case of termination of this Agreement by WCCI due to a breach by LEO. 
 3.8.2 Storage. WCCI represents and warrants that Products delivered hereunder will be stored in full accordance with the applicable Laws in the Territory, and with the instructions given by LEO, and the
national health authorities in the Territory. LEO has the right at any time during normal business hours, upon reasonable notice, to audit premises used by WCCI for holding and storage of Products in Territory and examine those parts of the
premises, procedures and documentation involved in the activities of this Agreement. 
 3.8.3 Changes in Product Labels and Printed
Materials. In the event that WCCI requests changes in product labels, printed packaging materials or packaging inserts for Products and LEO has components for such materials in stock that it has purchased specifically for such Product that can
no longer be used as a result of 
  

			
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 such changes, WCCI shall have the obligation to purchase the lesser of (a) all of the LEO stock of
such components and (b) six months supply of the LEO stock of such components, at cost. WCCI shall give LEO at least four (4) months’ notice in advance of any changes required to be made to the packaging materials. In case of
termination of this Agreement, caused solely by WCCI’s breach, WCCI shall reimburse LEO the cost of all packaging materials in stock, purchased specifically for the Products, at the time of such termination. 
 3.8.4 Repackaging. WCCI is not allowed to repack the Products or in any way change the original packaging of Products. 
  

	3.9	Representations, Warranties and Covenants of LEO. LEO hereby represents, warrants and covenants to WCCI as follows: 

 3.9.1 Valid Manufacturing Authorization. (a) LEO owns a valid Manufacturing Authorization issued by the relevant Governmental or Regulatory
Authority. 
     (b) LEO shall not make changes or take actions which will require WCCI to amend any Registration
including, but not limited, to transfer of any Product to alternative manufacturing facilities or changes in or replacement of equipment or a change in the Specifications, without the prior written consent of WCCI, which consent shall not be
unreasonably withheld; provided that such amendment is for good reason, and any costs relating to such change or action shall be at the sole expense of LEO. 
 3.9.2 Conformity with Specifications and Laws. Each Product delivered by LEO to WCCI hereunder has been Manufactured using a process that has been validated in accordance with current Good Manufacturing
Practices and has been Manufactured in compliance with the Specifications for such Product and with current Good Manufacturing Practices and all Laws with respect to the Manufacture of each Product. Each Product conforms to any further affirmation
of fact as may be made on or in any other documentation associated with or related to such Products. 
 3.9.3 Creation and Retention of
Records. LEO shall be responsible for creating and retaining all records relating to Manufacturing, analysis, testing and release of materials, production and quality control (including in-process controls) for each Product, all in accordance
with current Good Manufacturing Practices and shall provide copies to WCCI upon its reasonable request. 
  

			
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 3.9.4 Stability Studies. LEO shall conduct relevant stability studies on each Product to assure
validity of such Product for its shelf life in accordance with the requirements set forth in the NDA with respect to such Product. 
 3.9.5
Raw Materials and Products Provided by LEO. Except as otherwise specifically agreed between the Parties in writing, LEO shall be responsible for procuring all raw materials and other components for each Product. All raw materials and
components procured by LEO and used in the Products shall be tested (by LEO or the supplier thereof) to assure that they meet applicable Specifications and quality standards. 
 3.9.6 Packaging Material. Unless required by Law no changes may be made by LEO to the packaging material for any Product without the prior written
consent of WCCI. If changes are required by Law LEO shall consult with WCCI prior to the implementation of such changes. 
 3.9.7
Storage. LEO shall store the raw materials, excipients, packaging articles, intermediate products and the Products under such conditions that the quality of such materials and the Products Manufactured therefrom are not affected. 

3.9.8 Approval of Product Labels, Printed Packaging Materials and Inserts. Prior to the first production of each Product for WCCI, LEO shall
provide WCCI with information regarding the possible dimensions and parameters of product labels, printed packaging materials and inserts. Unless required by Law LEO will make no change to Product labels or Product inserts, submitted by WCCI in
accordance with Article 3.8.1, without the prior written approval of WCCI. If changes are required by Law LEO shall consult with WCCI prior to the implementation of such changes. 
 3.9.9 Reference Samples. LEO shall retain reference samples from each batch of Finished Products for the period of time required by applicable Law
after the expiry date. Finished Products will be kept in their final packaging and stored under the recommended conditions. Samples of starting materials (other than solvents, gases and water) will be retained for the period of time required by
applicable Law after the expiry date of the corresponding Finished Product. LEO 
  

			
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 shall retain samples sufficient to conduct at least two (2) re-examinations and an annual
evaluation. LEO shall make reference samples available for inspection, testing, analysis and examination by WCCI and any relevant Governmental or Regulatory Authority, promptly upon request of WCCI. 
 3.9.10 Validation. 
     (a) The equipment and facilities used for Manufacturing must be validated and qualified by LEO in accordance with current Good Manufacturing Practices. The results must be documented in writing. 
     (b) In the event that changes in the Manufacturing process or in the Specifications take place pursuant to this Agreement, LEO
shall perform such validations or revalidations as may be required by current Good Manufacturing Practices or reasonably requested by WCCI in writing. 
 3.9.11 Control Tests. 
     (a) LEO shall perform all control tests set forth in
the Specifications. LEO shall confirm compliance in the form of a statement on each certificate of analysis which follows the goods. 
     (b) At WCCI’s reasonable request, LEO shall make samples from each batch available to WCCI. If control tests which WCCI elects to have carried out on the samples or the Products reveal any failure thereof to
comply with the Specifications, WCCI shall promptly notify a named qualified person of LEO of said failure. In the event that the results of such control tests performed by WCCI shall differ from findings of LEO and no mutual agreement can be
reached in respect thereof, then the Parties shall jointly designate an independent laboratory for the purpose of having that sample or Product subjected to a third control test as promptly as practicable. Should non-compliance of the Product in
question be confirmed by such outside control, LEO undertakes to refund any payment already made to it with respect to such non-complying Product and to bear the cost of the third control test by such outside laboratory and replace such
non-complying Product in accordance with Article 3.7. LEO shall bear the full cost of proper destruction of any non-complying Product. Should compliance of the Product in question be confirmed by such outside control, WCCI undertakes to bear
the cost of 
  

			
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 such third control test and to pay for the Products in question. If the outside control is unable to
determine conclusively whether the Product in question is in compliance or not, the Parties shall share equally the expenses connected with the outside control and the expenses connected with the replacement and destruction of the allegedly
non-complying Product. 
 3.9.12 Batch Release. LEO shall ensure that each Product has been Manufactured in compliance with the
requirements of the Registration and shall release only batches accompanied by a certificate of compliance and analysis signed by a qualified person of LEO that the Product has been Manufactured by LEO according to the Specifications and that LEO is
committed to inform WCCI in the event of any change in the Manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In
preparing the certificate of compliance and analysis, a qualified person of LEO shall take into account analytical results, essential information such as the production conditions, the results of in-process controls and the examination of
Manufacturing documents. LEO shall create and retain records relating to each batch of the Product Manufactured hereunder in accordance with applicable Law. 
 3.9.13 LEO Resources. LEO has and will provide during the term of this Agreement appropriately qualified and trained personnel, adequate premises and space, suitable equipment and services, correct materials,
containers and labels, suitable storage and the knowledge and experience to carry out satisfactorily the supply of Finished Product to WCCI. 
 3.9.14 Key Personnel. LEO shall provide WCCI with a list of its Key Personnel for QC release along with specimens of their signatures or other appropriate identifiers such as electronic identification codes subject to adequate
security measures and shall keep WCCI informed as to changes in its Key Personnel from time to time. 
 3.9.15 Quality. LEO shall
refrain from any activity that will adversely affect the quality of any of the Products Manufactured for WCCI. 
 3.9.16 Quality Audit.
LEO shall make that portion of its manufacturing facilities where the Products are Manufactured, including all records and reference samples related to the Products, available for inspection by WCCI and representatives of 
  

			
	 DOVONEX® AGREEMENT
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 applicable Governmental or Regulatory Authorities during business hours. Records made available for
inspection hereunder shall include all records relevant to assessing the quality of a product in the event of a complaint or a suspected defect. Inspections by WCCI shall be conducted only by a duly authorized representative of WCCI or the relevant
Governmental or Regulatory Authority and shall be limited to determining whether there is compliance with current Good Manufacturing Practices, the Registration and other requirements of this Agreement and of applicable Law. In addition, the Parties
agree that a member of WCCI’s pharmaceutical quality assurance team may be present at all such inspections. In the event such representatives conclude that any non-conformity with such requirements is continuing, the Parties shall use their
respective best efforts to resolve the issue as quickly as possible. 
 3.9.17 Environmental; Health and Safety Matters. 

 

	 	(a)	LEO shall perform all of the services provided herein in compliance with all environmental Laws and shall be solely responsible for all environmental Losses at sites controlled by
LEO. 

  

	 	(b)	LEO shall be solely responsible for implementing and maintaining health and safety procedures for the Manufacture, generation, packaging, handling and storage of the raw materials,
hazardous materials, waste, packaging components and Products as provided herein. Such procedures shall comply with all relevant environmental Laws. WCCI shall have no responsibility for developing, implementing or overseeing health and safety
programs at LEO. 

  

	3.10	As soon as possible and no later than three (3) months following the Effective Date, LEO, LEO Laboratories Limited (an Affiliate of LEO) and WCCI will enter into a Quality
Agreement substantially in the form of Appendix VI. Until such agreement has been signed, the terms of Appendix VI shall apply. To the extent of any conflict or inconsistency between this Agreement and such Quality Agreement, the terms
of this Agreement shall control, unless otherwise agreed to in writing between the Parties. 

  

	3.11	Products shall have a minimum shelf life of sixteen (16) months from the date of shipment. 

  

			
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	3.12	Notice of Noted Incidents and Abnormal Results. The Parties shall promptly inform each other in writing of any incident that would be reportable to the applicable
Governmental or Regulatory Authority. 

 IV- MARKETING 
  

	4.1	WCCI shall use commercially reasonable efforts to market the Products in the Territory. WCCI shall bear all of the cost and expense of advertising and promoting the Products in the
Territory. WCCI’s advertising and promotional materials shall be in accordance with the claims approved by the FDA. WCCI shall not use any advertising or promotional materials, which are not consistent with the basic statements of LEO regarding
the Products. The respective departments within LEO and WCCI will communicate to discuss any relevant issues regarding basic statements. WCCI shall provide LEO with samples of its promotional material. 

 Regular meetings will be held between WCCI and LEO in order to discuss the ongoing business. WCCI shall annually prepare a business plan for the
forthcoming calendar year. The business plan shall contain a forecast of sales based on market information data and allocation of resources. WCCI shall deliver a draft business plan by 1 August and a final business plan by 30 October of
each successive calendar year. The Parties shall discuss each such business plan at a meeting to be held no later than 15 September of each year, and WCCI shall in good faith take into account changes to such business plan recommended by LEO.

 WCCI shall provide LEO with quarterly market updates. WCCI and LEO shall at the above mentioned business plan meeting in September each
year agree upon minimum sales for the ensuing year, taking into account, among other things, market conditions, regulatory issues and competition. If WCCI and LEO are unable to agree upon minimum sales or any other matter to be agreed under this
Agreement, the matter shall be referred to the Chief Executive Officers of each Party for good faith resolution. If the Chief Executive Officers of each Party are unable to agree upon minimum sales within 45 days the minimum sales will be fixed by
an independent third party acceptable to both Parties, the cost of such third party to be shared equally by the Parties. In the event of circumstances that change the assumptions made at the time the minimum sales were agreed, e.g., introduction of
a generic of the Product or serious limitations in the use of the Product for psoriasis become apparent, then the Parties shall meet in good faith and adjust the minimums. 
  

			
	 DOVONEX® AGREEMENT
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 If WCCI is unable to achieve the agreed minimum sales then this Agreement can be made non-exclusive upon
90 days’ written notice to WCCI, provided, however, that WCCI shall be permitted during such 90 day period to pay an amount equal to the shortfall between the minimum purchase quantities and the actual quantity of Product purchased, and upon
such payment to avoid the conversion of this Agreement to a non-exclusive agreement. 
  

	4.2	Reasonable quantities of Product samples required in accordance with WCCI’s marketing plans will be delivered at the sample price. At the time of signing of this Agreement the
sample price is USD 0.48 for a 3 gram or 8 ml sample. The sample price shall be adjusted for inflation once each year effective 1 January, in an amount equal to the increase according to the latest update in the official “Summarisk
lønindeks for den private sektor i Danmark” (Danish Index of Average Earnings by Industry in the Private Sector), see www.dst.dk. 

  

	4.3	Within five (5) working days following the end of any calendar month WCCI shall send to LEO a sales and stock report in a form that LEO may from time to time specify, showing
in respect of each particular size and type of Products the number of and the value in USD of units sold during the previous calendar month, the stock of Products and monthly sales forecasts for the following twenty-four (24) months.

  

	4.4	WCCI shall keep its accounts updated in such a manner that control of sales of the Products and other WCCI Information regarding payment can be made by LEO who shall be entitled to
audit WCCI’s accounts in accordance with Article 5.3. 

  

	4.5	WCCI shall not perform any pre-clinical or clinical studies, seeding trials, observational studies or any other pre or post marketing studies relating to the Products, without the
prior written consent of LEO and the prior written approval of the protocols by LEO, such consent and approval not to be unreasonably withheld. Products to be used in any such studies shall be delivered by LEO to WCCI at a price equivalent to 75% of
the purchase price as defined in Article 3.2. The performance, funding and use of data and results related to certain of such studies and trials are further described in Article 3 of Addendum I to the Master Agreement, which is hereby
incorporated by reference in this Agreement and which is hereby deemed to be part of this Agreement. 

  

			
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	4.6	WCCI shall keep LEO currently informed of any relevant new developments in the pharmaceutical market in the Territory, e.g. changes in governmental policies which may affect the
Registrations obtained or applied for, import and sales of the Products, competitors’ activities and attitudes among the medical profession. Further, the Parties shall keep each other fully informed about all new information relevant for
Products in the Territory. 

 WCCI shall also keep LEO informed of WCCI’s chains of distribution for Products in the
Territory. 
 V- ACCOUNTING AND ROYALTY PAYMENT 
  

	5.1	In consideration of the rights granted in Article II WCCI shall pay to LEO a royalty calculated on the Net Sales of Products sold by WCCI or its Affiliates in the Territory
in consideration of the Patent, Technical Information and Trademark licenses granted by LEO to WCCI in Article II. The royalty rate will be ten percent (10%) on Net Sales for as long as no generic competition exists. Generic competition
within the meaning of this Article 5.1 means ten percent (10%) or more in terms of IMS unit sale market share. If generic competition arises the royalty rate will be reduced to five percent (5%). 

  

	5.2	The report rendered by WCCI pursuant to Article 3.3.1 shall also include a calculation of royalty payments due pursuant to Article 5.1 for the preceding calendar
quarter, such royalties to be paid at the time of delivery of the report. 

  

	5.3	WCCI agrees to keep accurate records in sufficient detail to enable the royalties payable hereunder and the invoice adjustments as mentioned in Article 3.3.1 to be
determined, and upon the request of LEO, shall permit an independent, certified public accountant selected by LEO (except one to whom WCCI has some reasonable objection), at the sole expense of LEO, to have access during ordinary business hours to
WCCI’s records (a) to determine the correctness of any report and/or payments made under this Agreement or (b) to obtain information as to the royalty payable for any such period in case of WCCI’s failure to report or pay
pursuant to this Agreement. Notwithstanding the prior sentence, in the event such 

  

			
	 DOVONEX® AGREEMENT
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 inspection discloses that any payments made to LEO pursuant to Articles 5.1 or 3.3
hereunder for any accounting period were deficient by more than 5%, WCCI shall reimburse LEO for the cost of such inspection. This right of review shall terminate three (3) years after receipt by LEO of WCCI’s quarterly account. Said
accountant shall not disclose to LEO any information other than information relating to the accuracy of the reports and payments made under this Agreement and in no event are the quantities and prices to individual customers to be disclosed to LEO.

  

	5.4	Royalties shall be computed upon Net Sales sold by WCCI and shall be remitted in United States Dollars via bank transfer to an account designated by LEO in writing.

  

	5.5	If Laws require withholding of taxes imposed upon LEO on account of royalties accruing under this Agreement, such taxes will be deducted by WCCI from such remittable royalty and
will be paid by WCCI to the proper taxing authority. Proof of payment shall be secured and sent to LEO as evidence of such payment. 

  

	5.6	In no case shall the sums received by LEO as royalties for sale of Products be returned to WCCI unless found to be in error. 

 VI - PATENT PROTECTION AND VALIDITY 
  

	6.1	LEO agrees to prosecute and maintain the Patents within the Territory and shall (i) consult in good faith with WCCI regarding such prosecution and maintenance on a regular
basis and (ii) provide WCCI with copies of draft patent applications and consider in good faith any comments provided by WCCI thereon. 

  

	6.2	LEO agrees to use commercially reasonable efforts to prevent infringement of the Patents and WCCI, to the extent it has knowledge, shall notify LEO of any such infringement. When a
third party, in WCCI’s opinion, infringes the Patents and the infringement is expected to constitute a substantial unlicensed competition, WCCI shall provide LEO with any available evidence of the infringement. LEO shall use all reasonable
measures, whether by Action or Proceeding or otherwise to prevent such infringement. All costs and expenses of such Action or Proceeding or other activity, unless collected from the third party against which the same is brought, shall be borne by
LEO. WCCI shall, at the request of LEO, co-operate with LEO in all respects including, but not limited to, making available to LEO or its legal representative, all relevant papers, records, information, samples, specimens, and

  

			
	 DOVONEX® AGREEMENT
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 the like. WCCI shall use its commercially reasonable efforts to cause any of its employees to testify
when requested by LEO. Any monetary recovery obtained by LEO as the result of such Action or Proceeding, by settlement or otherwise, shall after deduction of costs and expenses involved in such a proceeding be shared equally by the Parties. LEO
shall provide WCCI with regular updates concerning any infringement of its patents by a third party including, without limitation, relevant correspondence, court filings, analysis and information and shall consult in good faith with WCCI regarding
its efforts to prevent such infringement. 
 VII - THIRD PARTIES INTELLECTUAL PROPERTY CLAIMS 
  

	7.1	If an Action or Proceeding is filed by any third party against WCCI as defendant alleging that WCCI’s operation under the licensed Patents, Trademark and/or the Technical
Information constitutes an infringement of the intellectual property rights of the said third party, LEO, upon WCCI’s request, shall use its best efforts to make available to WCCI any relevant records, papers, expert information, samples,
formulae and the like, and shall co-operate in such defence with WCCI as may be reasonably requested by it. 

  

	7.2	In case of such Action or Proceeding or threat thereof, WCCI shall notify LEO promptly. Should WCCI decide not to take up the defence, LEO may at its sole discretion take up the
defence itself, but is under no obligation to do so. If and when LEO takes up a defence WCCI shall, upon the request of LEO, assist LEO to the best of its ability with legal and technical advice and assistance, evidence and documentation. Fifty
percent (50%) of the royalty payments necessitated by a settlement may be deducted from WCCI’s obligation under Article 5.1, provided that this deduction does not reduce the royalty payments in Article 5.1 by more than fifty
percent (50%). However, WCCI shall consult with LEO in case such settlement may involve other payments. 

  

	7.3	This Agreement is deemed to continue in full force, including WCCI’s obligation to pay full royalty during a pending action or proceeding instituted by third party due to
WCCI’s working under licensed Patent or Trademark rights and/or Technical Information granted hereunder. However, for as long as such action or proceeding is pending WCCI shall escrow the royalty due in a bank acceptable to LEO. If WCCI is
ultimately held liable to any third party who brings suit, then WCCI can deduct any payments made to said third party in the form of damages or royalty payments from the above escrow account and then from its obligation under Article 5.1.

  

			
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 VIII - CONFIDENTIALITY 
  

	8.1	The confidentiality provisions of the Confidentiality Agreement (excluding Article 9 of the Confidentiality Agreement – Governing Law and Venue) are hereby incorporated by
reference in this Agreement and are hereby deemed to be part of this Agreement. 

  

	8.2	For the avoidance of doubt also this Agreement and the existence and terms of this Agreement are regarded as Confidential Information (as defined in the Confidentiality Agreement).
Notwithstanding anything to the contrary set forth herein or in the Confidentiality Agreement, WCCI and its Affiliates may disclose Confidential Information relating to this Agreement including, without limitation, the existence and terms of this
Agreement (i) in a filing with the United States Securities and Exchange Commission (the “SEC”) or any securities exchange if such disclosure is required pursuant to applicable Law, (ii) in any documentation provided to the
United States Patent and Trademark Office for the purpose of recording the license granted to WCCI hereunder, (iii) to any third party if such Confidential Information is part of a report of the information that would be required to be
contained in a report on Form 8-K, a quarterly report on Form 10-Q or an annual report on Form 10-K if WCCI were required to file such form with the SEC, or (iv) to a third party on a confidential basis if such disclosure is otherwise required
pursuant to (x) the Credit Agreement dated as of January 18, 2005 among Warner Chilcott Holdings Company III, Limited and certain of its subsidiaries, Credit Suisse First Boston and the other lenders party thereto or (y) the Indenture
dated as of January 18, 2005 between Warner Chilcott Corporation and Wells Fargo Bank, National Association; provided that WCCI shall provide LEO with a copy of the information relating to this Agreement that will be disclosed in advance of
such disclosure (other than the Agreement itself). 

 IX - REGISTRATIONS 
  

	9.1	LEO will be the owner and holder of the Registrations for the Products in the Territory. LEO will, at the request of WCCI, provide WCCI with a complete copy including any
correspondence with the FDA as well as other relevant documents in 

  

			
	 DOVONEX® AGREEMENT
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 the possession or control of LEO. LEO will appoint WCCI as its U.S. agent for purposes of the NDA and
will timely supply WCCI with all information in its possession or control necessary to prepare and file reports required by the FDA. WCCI will act as U.S. agent and will keep Registrations updated, including, but not limited to, to maintaining the
NDA and the IND and forthwith to inform and copy LEO with the updates. 
  

	9.2	Both Parties are entitled to participate in and shall be notified in advance by the other Party of all meetings with the FDA provided such participation does not result in any
significant delay. The Parties shall, in addition, cooperate with one another to keep the other Party informed of any other interface or communication with the FDA which might adversely affect the activities of a Party under this Agreement.

  

	9.3	Prior to submitting any correspondence or other information relating to the Products to the FDA (an “FDA Submission”), the sponsoring Party (the
“Sponsor”) shall (i) provide the other Party with a copy of the FDA Submission and (ii) in the case of a material FDA Submission, provide the other Party with a reasonable opportunity to review such FDA Submission and the
Sponsor shall discuss in good faith any comments or proposed changes to such submission proposed by the other Party. 

 X - TRADEMARKS

  

	10.1	LEO is responsible for registration, maintenance and defense of the Trademark of the Products in the Territory. WCCI shall, immediately upon its knowledge hereof, be obliged to
inform LEO of any possible infringement of the Trademark. WCCI agrees to use the Trademark only in accordance with standards and guidelines communicated by LEO from time to time during the term of this Agreement. WCCI agrees that its use of the
Trademark shall be in a commercially acceptable and responsible manner, and that no use by it of the Trademark shall reflect adversely upon the good name of LEO. All goodwill deriving from the use by WCCI of the Trademark pursuant to the terms of
this Agreement or otherwise arising out of this Agreement shall accrue solely and exclusively to LEO. 

  

	10.2	WCCI shall not at any time register, or cause to be registered, in its name or in the name of another, or authorize the use of, during or after the term of this Agreement, the
Trademark or any other trademark, name or design resembling or 

  

			
	 DOVONEX® AGREEMENT
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 similar to the Trademark. WCCI shall not use the Trademark in combination with another, as part of a
trade name or service mark of any corporation or other business organization except with the prior written consent of LEO. 
  

	10.3	WCCI and LEO are not, without the other Party’s written consent, in any way electronically on the Internet or otherwise, entitled to use or register any of the other
Party’s intellectual property rights such as, but not limited to, trademarks, product names, descriptions etc. LEO shall upon the reasonable request of WCCI register domain names containing the Trademarks. WCCI is not, without the written
consent of LEO, in any way entitled to sell or promote any of the Products via the Internet. It being understood that sale of the Products via the Internet by a customer of WCCI does not constitute a breach of this provision. Subject to the second
paragraph of Article 2.1, WCCI is expressly permitted to maintain a website for each Product which provides product information, disease state information and other useful information consistent with the provisions of Article 4.1.

  

	10.4	All packaging and promotional material shall include the LEO logo and the Assyrian lion. The packaging and promotional material shall adhere to the LEO Logo Guidelines.

 XI - AUTHORISATIONS 
 In accordance with
legislation of the European Union, recipients of supplies of medicinal products must be in possession of a manufacturing or importing authorisation for medicinal products or an authorisation to engage in activity as a wholesaler of medicinal
products. Accordingly, for the duration of this Agreement WCCI shall be in possession of relevant and valid authorisation(s) covering the Territory. A copy of the present authorisation(s) is attached as Appendix VII. WCCI shall forward copies
of renewals of relevant authorisations to LEO whenever such authorisations expire and are renewed. 
 XII - QUALITY ASSURANCES 
  

	12.1	LEO warrants that Products sold to WCCI are of pharmaceutical grade and quality suitable for human use and that it meets the Specifications as such Specifications may be revised
from time to time as provided herein and that such Products conform to any further affirmations of fact as may be made on or in any other documentation associated or related to such Products. 

  

			
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	12.2	In the event WCCI determines that any Products already in interstate commerce in the Territory present a risk or injury or gross deception or is otherwise defective and that recall
of such Products is appropriate, WCCI shall conduct such recall in accordance with FDA guidelines and with the provisions as set out in Article 13.2. LEO shall fully co-operate with WCCI in the investigation of the cause of the recall. If the
Parties agree that the cause of the recall was the fault of LEO, LEO shall reimburse the WCCI cost and expense associated with such recall provided, however, that liability of LEO under this provision shall not extend to any consequential damages
associated with such recall. 

 XIII - SAFETY REPORTING, COMPLAINTS AND PRODUCT RECALL 
  

	13.1	As soon as possible and no later than three (3) months following the Effective Date, LEO and WCCI will enter into a Pharmacovigilance Agreement substantially in the form of
Appendix VIII. Until such agreement has been signed by both Parties, the terms of Appendix VIII shall apply. To the extent of any conflict or inconsistency between this Agreement and such Pharmacovigilance Agreement, the terms of this
Agreement shall control, unless otherwise agreed to in writing between the Parties. 

  

	13.2	WCCI must put in place a system for handling of customer complaints and product recall, which is in compliance with the guidelines furnished by LEO. LEO Guidelines “Group
Policy – GP 07/rev. 3 Investigation of Customer Complaints” and “Group Policy – GP-08/04 Recall of LEO Products and Investigational Medicinal Products”, Appendix IX. 

 XIV - RESPONSIBILITIES OF PARTIES 
  

	14.1	Compliance with Laws. Both LEO and WCCI shall observe all applicable Laws in effect in fulfilling their obligations under this Agreement. 

  

			
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	14.2	Indemnification. 

 14.2.1 Indemnification by LEO. In
addition to the remedies set forth in Article 3.7, LEO shall indemnify and hold WCCI and its agents, directors, officers and employees and representatives harmless from and against any and all Losses which they may at any time incur by reason
of any Action or Proceeding brought by any Governmental or Regulatory Authority or other third party against WCCI arising out of or resulting from (a) any misrepresentation, breach of warranty or non-fulfilment of or failure to perform any
agreement or covenant made by LEO in this Agreement, (b) the use by WCCI of any Product delivered by LEO (including Product delivered by LEO to BMS which is acquired by WCCI) which does not comply with the Specifications therefor, or
(c) any other negligent act or omission of LEO. 
 14.2.2 Indemnification by WCCI. WCCI shall indemnify and hold LEO and its
agents, directors, officers and employees and representatives harmless from and against any and all Losses which they may at any time incur by reason of any Action or Proceeding brought by any Governmental or Regulatory Authority or other third
party against LEO arising out of or resulting from (a) any misrepresentation, breach of warranty or non-fulfilment of or failure to perform any agreement or covenant made by WCCI in this Agreement, (b) product liability claims other than
those against which LEO has indemnified WCCI pursuant to Article 14.2.1, including, but not limited to, liability claims arising from improper storage of Products by WCCI or damage in transit to Products, or (c) any other negligent act
or omission of WCCI. 
 14.2.3 Survival. The obligation of the Parties in this Article XIV shall survive the expiration or
earlier termination of this Agreement to the extent permitted by applicable Law. 
  

	14.3	In any case under the preceding Article 14.2, where WCCI or LEO is to indemnify the other, the control of the defence of any Action or Proceeding and negotiations for
settlement and compromise thereof, shall repose with the indemnifying Party, except that nothing in this paragraph shall be construed to relieve either Party hereto of the obligation to give the other all reasonable co-operation, assistance and
authority necessary to permit full and complete defense of any Action or Proceeding; provided, however, that no Party will settle any of such claims 

  

			
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 without consent of the other Party; however, such consent shall not be unreasonably withheld. Both
Parties shall, if desired, be allowed to participate, at their own expense, directly or through a representative e.g. their product liability insurers, in any Action or Proceeding. 
 XV - TERM AND TERMINATION; CONSEQUENCES OF TERMINATION 
  

	15.1	This Agreement shall become effective on the Effective Date, and shall continue in full force and effect as provided herein, unless modified or terminated in accordance with any of
the provisions hereof, until the later of (A) the expiration of the term of the DC Agreement and (B) 27 January 2020. 

  

	15.2	In the following events, LEO shall have the right to terminate this Agreement with immediate effect by written notice: 

 15.2.1 If the option to purchase the rights and assume the obligations of BMS under the BMS Agreements, exercised by WCCI on 2 September 2005, does
not come into effect as of 6 January 2006 at the latest. 
 15.2.2 If the DC Agreement is terminated due to WCCI’s default or breach
of said agreement. 
  

	15.3	In the event that WCCI and LEO agree, at any time after the seventh anniversary of the launch of Products, that further commercialisation of Products no longer are sound due to
therapeutic or economic reasons, then either Party can with six (6) months’ prior notice terminate this Agreement. 

  

	15.4	In the event that one of the Parties hereto materially defaults or breaches any of the provisions of this Agreement, the other Party shall have the right to terminate this Agreement
upon sixty (60) days’ written notice, provided, however, that if the Party in default within the sixty day period referred to, remedies the said default or breach, the Agreement shall continue in full force and effect.

  

	15.5	In the event that the FDA does not approve a Registration for the Combination Product and there is no reasonable possibility to obtain approval, WCCI shall – within 90 days
– have the right to terminate this Agreement upon ninety (90) days’ written notice. 

  

			
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	15.6	In the event that the patent application filed by LEO with the United States Patent and Trademark Office for the Combination Product is rejected by the Patent Examiner and the route
of appeal of such rejection has been exhausted or is not diligently pursued by LEO or LEO has not obtained a U.S. patent within five (5) years from the date of filing of such application with the United States Patent and Trademark Office, then
WCCI may terminate this Agreement within ninety (90) days of such rejection of appeal, or on ninety (90) days’ notice to LEO that LEO is not diligently pursuing such appeal, without any further obligation to LEO.

  

	15.7	In the event that one of the Parties hereto enters into liquidation whether compulsorily or voluntarily (otherwise than for the purposes of amalgamation or reconstruction),
compounds with its creditors, has a receiver or manager appointed in respect of all or any part of its assets, or is the subject of an application for an administration order or undergoes any analogous or similar act or proceeding under the laws of
any other jurisdiction in consequence of debt the other Party shall have the right to terminate this Agreement with immediate effect by written notice. 

  

	15.8	If WCCI – for any three (3) consecutive calendar years – is unable to achieve the agreed minimum sales, LEO shall have the right to terminate this Agreement upon
sixty (60) days’ written notice. 

  

	15.9	In the event of termination of this Agreement under the provisions of this Article XV LEO and WCCI shall not be relieved of the duty and obligation to pay in full all
payments, including but not limited to royalties, accrued and unpaid at the effective date of such termination. In such event: 

 15.9.1 WCCI shall return any and all Technical Information and any other information relating to the Product(s) provided to WCCI and make no further use thereof; 
 15.9.2 WCCI shall cease to make use of the Trademark, the other LEO Product Branding and all other information related to the Product(s), and all rights in the Trademark, the other LEO Product Branding and all other
information relating to said Product(s) will promptly revert to LEO and be transferred to LEO; 
  

			
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 15.9.3 if WCCI is then the owner of any patents specifically related to Product(s), WCCI shall transfer
such ownership to LEO, except for LEO being in breach in which case WCCI will sell said patents and LEO will purchase said patents at a price equal to the expenses WCCI has borne in relation to developing, establishing and maintaining said patent
rights; 
 15.9.4 if WCCI is then the owner of any patents, which in part relates to Product(s) then LEO, its Affiliates and Product Licensees
shall have a royalty free license to such patents for the term of the patents pursuant to a separate license agreement to be entered into by the Parties; 
 15.9.5 if WCCI is then the owner of any data related to the Product(s), including but not limited to, any data related to any study performed under this Agreement such data shall be transferred to LEO. At such time,
LEO shall have the right, but not the obligation, to have assigned to LEO any then pending third party clinical agreement; 
 15.9.6 WCCI
shall transfer all Registrations related to Product(s) held by WCCI, if any to LEO or its designee. 
 In the event that LEO terminates this
Agreement pursuant to Articles 15.2, 15.4, 15.7 or 15.8, the transfers required under Articles 15.9.1, 15.9.2, 15.9.3, 15.9.5 and 15.9.6 shall be made free of charge to LEO. Otherwise,
the costs of transfers shall be split evenly between the Parties. 
  

	15.10	It is understood that WCCI – also after termination of the Agreement – shall be solely liable for any and all chargebacks and returns of Products sold by WCCI under the
Agreement. WCCI shall destroy all returns of Products it receives also after the termination of the Agreement. Following such destruction, WCCI shall certify the destruction to LEO upon the written request of LEO. 

 XVI - ASSIGNABILITY 
  

	16.1	This Agreement and the licenses and rights herein granted shall be binding upon, and shall inure to the benefit of successors of the Parties hereto, or to any assignee of all of the
good will and entire business assets of a Party hereto relating to pharmaceuticals, but shall not otherwise be assignable without the prior written consent of the other Party. 

  

			
	 DOVONEX® AGREEMENT
	 	32

	16.2	Furthermore, in the event WCCI merges with or is acquired by a company and the new entity no longer gives priority to dermatology or in the event WCCI merges with or is acquired by
a company having a product which is a topical vitamin D3 or any analog thereof or a fixed combination of vitamin
D3 or any analog thereof with a corticosteriod with indications that directly compete with the indications approved
for any of the Products and such product has sales, at the time of such transaction, equal to at least 10% of the Net Sales of Products, and such products are not divested or out-licensed, then the rights granted herein are not assignable without
the prior written consent of LEO, which consent shall not be unreasonably withheld. If LEO does not consent, then LEO is obliged to acquire the rights granted WCCI including all necessary approvals for marketing of the Product by paying to WCCI one
(1) times WCCI’s Gross Margin for the Products for the twelve (12) months preceding the event, or if there is less than twelve (12) months of sales by WCCI, the Gross Margin of such pro rata period multiplied to equal a period of
twelve (12) months. 

  

	16.3	For the avoidance of doubt, LEO agrees and acknowledges that WCCI may perform any or all of its obligations under this Agreement through its U.S. Affiliate, Warner Chilcott (US),
Inc. (“WCUI”), provided however, that WCCI shall remain jointly and severally liable for the performance of any obligations that are delegated to WCUI. 

  

	16.4	Warner Chilcott Holdings Company III, Limited is jointly and severally liable for the performance of any obligations of WCCI hereunder. 

 XVII - AMENDMENT OF AGREEMENT; WAIVER; SEVERABILITY 
 17.1 The
Agreement shall not be changed or modified orally. 
 17.2 Any term or condition of this Agreement may be waived at any time by the Party that is entitled to
the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. No waiver by either Party of any term or condition of this Agreement, in
any one or more instances, shall be deemed to be or construed as a waiver of the 
  

			
	 DOVONEX® AGREEMENT
	 	33

 same or any other term or condition of this Agreement on any future occasion. All remedies, either under this Agreement
or by Law or otherwise afforded, will be cumulative and not alternative. 
 17.3 If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any applicable present or future Law, and if the rights or obligations of any Party hereto under this Agreement will not be materially and adversely affected thereby, (a) such provision will be fully severable, (b) this
Agreement will be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement will remain in full force and effect and will not be affected by
the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, the Parties will add as a part of this Agreement, a legal, valid and enforceable provision as
similar in terms to such illegal, invalid or unenforceable provision as may be possible. 
 XVIII - STATUS OF PRIOR AGREEMENT 
 This Agreement, together with the Master Agreement, the DC Agreement, the Development Agreement (as defined in the Master Agreement), the Amended and Restated Cooperation
Agreement (as defined in the Master Agreement) and the Confidentiality Agreement, constitutes the entire Agreement between the Parties with respect to the within subject matter and supersedes all previous agreements, whether written or oral.

 XIX - FORCE MAJEURE 
 The occurrence of an event which
materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected, not due to malfeasance, and which could not with the exercise of due diligence have
been avoided (“Force Majeure”), including, but not limited to, fire, accident, labor difficulty, strike, riot, civil commotion, act of God, delay or errors by shipping companies or change in Law shall not excuse such Party from the
performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of Force Majeure. The Party prevented from performing its obligations or duties because of Force Majeure shall promptly
notify the other Party hereto (the “Other Party”) of the occurrence and particulars of such Force Majeure and shall provide the Other Party, from time to time, with its best estimate of 
  

			
	 DOVONEX® AGREEMENT
	 	34

 the duration of such Force Majeure and with notice of the termination thereof. The Party so affected shall use its best
efforts to remove or ameliorate such causes of nonperformance. Upon termination of Force Majeure, the performance of any suspended obligation or duty shall promptly recommence. Neither Party shall be liable to the Other Party for any direct,
indirect, consequential, incidental, special, punitive or exemplary damages arising out of or relating to the suspension or termination of any of its obligations or duties under this Agreement by reason of the occurrence of Force Majeure. In the
event that Force Majeure has occurred and is continuing for a period of at least six (6) months, the Other Party shall have the right to terminate this Agreement upon thirty (30) days’ notice. 
 XX - NON-COMPETITION CLAUSE 
 During the term of this Agreement WCCI
is not allowed to purchase, distribute, market and/or sell any product which is a topical vitamin D3 or any analog
thereof or a fixed combination of vitamin D3 or any analog thereof with a corticosteriod with indications that
directly compete with the indications approved for the Product, except the Combination Product. 
 XXI - PARTNERSHIP/AGENCY; THIRD PARTIES 

None of the provisions of this Agreement shall be deemed to constitute the relationship of partnership or agency between the Parties and neither Party shall have any
authority to bind the other Party in any way except as provided in this Agreement. 
 The Parties agree that no third party which is not a Party to this
Agreement is intended to benefit from or shall have any right to enforce any provision of this Agreement. 
 XXII - GOVERNING LAW 
 THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED
ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW PRINCIPLES OF SUCH STATE OTHER THAN SECTION 5-1401 OF THE NEW YORK GENERAL OBLIGATIONS LAW. 
 Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme Court of the State of New York, New York County, and (b) the United States District Court for the 
  

			
	 DOVONEX® AGREEMENT
	 	35

 Southern District of New York, for the purposes of any suit, action or other proceeding arising out of this Agreement or
any transaction contemplated hereby or thereby. Each Party agrees to commence any such action, suit or proceeding either in the United States District Court for the Southern District of New York or if such suit, action or other proceeding may not be
brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each Party further agrees that service of any process, summons, notice or document by registered mail to such Party’s respective
address set forth above shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Article XXII. Each Party irrevocably and
unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the transactions contemplated hereby and thereby in (i) the Supreme Court of the State of New York, New York County
or (ii) the United States District Court for the Southern District of New York, and hereby and thereby further irrevocably and unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient forum. 
 Each Party hereto hereby waives to the fullest extent permitted by applicable Law,
any right it may have to a trial by jury in respect to any litigation directly or indirectly arising out of, under or in connection with this Agreement. 
 XXIII- NOTICES 
 Any notice hereunder shall be deemed to be sufficiently given if sent by registered mail or
by fax followed by mail to: 
  

			
	In the case of WCCI:	  	Warner Chilcott Company, Inc.
		  	Att. Director, Business Management
		  	P.O. Box 1005
		  	Fajardo, Puerto Rico 00738
		
		  	Fax: + 1 787 863 5355
		
	With a copy to:	  	Senior Vice President and General Counsel
		  	Warner Chilcott
		  	100 Enterprise Drive
		  	Rockaway, New Jersey 07866
		
		  	Fax: + 1 973 3310

  

			
	 DOVONEX® AGREEMENT
	 	36

			
	In the case of LEO:	 	LEO Pharma A/S
		 	Att. The President, CEO
		 	Industriparken 55
		 	DK-2750 Ballerup
		 	Denmark
		
		 	Fax: + 45 72 26 32 95

 or to such other address as the sender shall have last furnished to the receiver.

 IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly executed in duplicate by their authorised officers as of the date last
below written. 
  

							
	WARNER CHILCOTT COMPANY, INC.	  	LEO Pharma A/S
				
	By:	 	 /s/ Max Torres
	  	By:	  	 /s/ Ernst Lunding

		 	Max Torres	  		  	Ernst Lunding
	Title:	 	Director, Business Management	  		  	Title: President, CEO
	Date:	 	September 14, 2005	  		  	Date: September 14, 2005

  

			
	 DOVONEX® AGREEMENT
	 	37Right of First Refusal Agreement

 Exhibit 10.34 
 Right of First Refusal 
 Agreement 
 between 
 WARNER CHILCOTT COMPANY, INC., of P.O. Box 1005,
Fajardo, Puerto Rico, 00738 (“WCCI”) 
 and 
 LEO PHARMA A/S, of Industriparken 55, DK-2750 Ballerup, Denmark (“LEO”) 
 (collectively, the “Parties” and individually a “Party”). 
 Capitalized terms not otherwise defined herein shall have the meanings set forth in Article 1 of this Right of First Refusal Agreement (this
“Agreement”). 
 WHEREAS the Parties are interested in collaborating on the development and marketing of certain products in the Territory,

 WHEREAS the Parties have entered into a series of inter-related agreements relating to D/DC Products, and

 WHEREAS LEO wishes to offer a first right of refusal with respect to the Non D/DC Derm Products to WCCI.

 NOW THEREFORE the Parties hereby agree as follows: 
 Article 1 
 Definitions

  

	1.1	“Confidential Information” shall have the meaning ascribed to it in the Confidentiality Agreement. 

  

	1.2	“Confidentiality Agreement” shall mean the Confidentiality Agreement dated as of 4 July 2005 between the Parties. 

  

	1.3	“DC Agreement” shall mean the License, Supply and Development Agreement dated as of even date herewith between the Parties relating to certain D/DC Products (as
defined below), as may be amended from time to time. 

  

	1.4	“D/DC Products” shall mean (i) the pharmaceutical formulations containing calcipotriol (calcipotriene) as the only active pharmaceutical ingredient (including
Dovonex® ointment, cream and scalp solution) and any other such formulations and (ii) the pharmaceutical formulations containing calcipotriol (calcipotriene) and steroid including Dovobet® ointment, LEO 80185, LEO 80190 and any other
such formulations, in each case, in any form including, but not limited to, an ointment, cream, gel, solution, foam, mousse or liquid, whether such formulation has been developed, is being developed or may be developed in the future.

  

	1.5	“Master Agreement” shall mean the Master Agreement dated as of 1 April 2003 between GALEN (CHEMICALS) LIMITED and LEO, as amended by WCCI and LEO on the date
hereof and as may be amended from time to time hereafter (with the consent of LEO GALEN has assigned its rights and obligations under the Master Agreement to its affiliate, WCCI). 

  

	1.6	“Non D/DC Derm Product” shall mean products that are developed (i) by LEO or (ii) by a third party and licensed to LEO, in each case, principally for the
treatment or prevention of dermatological diseases (developed as a separate product for the treatment or prevention of dermatological diseases, i.e. with its own NDA or supplement to an NDA, dosage regimen, packaging and tradename), other than D/DC
Products. 

  

	1.7	“Territory” shall mean the United States of America, the District of Columbia, its territories and current possessions. 

  

	1.8	“Territory Product” shall mean any Non D/DC Derm Product developed for distribution and sale solely within the Territory. 

  

			
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 Article 2 
 Right of First Refusal to products that are developed by LEO principally 
 for the treatment or
prevention of dermatological diseases 
  

	2.1	LEO will notify WCCI and provide all relevant information and data relating to Non D/DC Derm Products to WCCI after LEO has completed the end of Phase II trial (proof of concept);
provided that for any Territory Product, LEO may notify WCCI at any time prior to the end of Phase II trial (proof of concept) for such product. With respect to products in-licensed by LEO from a third party, LEO will in good faith use
commercially reasonable efforts to obtain the right to sublicense such products to WCCI in the Territory. In the event that LEO is unable to obtain a license for such in-licensed product in the Territory or LEO is unable to obtain the right to
sublicense such in-licensed product to WCCI, LEO will not be obligated to offer a license to WCCI. 

  

	2.2	Within sixty (60) days after receipt of such notice and information, WCCI may elect to make an offer to license, on an exclusive basis (subject to Article 3), such Non D/DC
Derm Product in the Territory, by notifying LEO. If WCCI elects not to make such an offer, LEO is free to offer such product to any third party at any time and shall have no obligations towards WCCI with regard to such product. If WCCI elects to
make an offer by notifying LEO, WCCI and LEO shall exclusively negotiate in good faith the terms of a written agreement for the license of the product. If the parties cannot agree on mutually acceptable terms within sixty (60) days of such
offer, LEO may solicit offers from other parties. 

  

	2.3	Subject to Article 2.2, if LEO receives a written bona fide offer from an unaffiliated third party (a “Bona Fide Offer”) that is more favorable than
WCCI’s offer, LEO shall notify WCCI of such offer within five (5) business days after receipt of such offer. Within ten (10) business days after WCCI is notified of the Bona Fide Offer, WCCI and LEO shall refer WCCI’s offer and
the Bona Fide Offer to an independent third party valuation specialist (such as a reputable investment bank) mutually acceptable to WCCI and LEO (the “Valuation Specialist”). Concurrently with delivery of the offers to the Valuation
Specialist, LEO shall provide the Valuation Specialist with a calculation of projected net sales, based on LEO’s forecast of the unit sales, projected gross invoice price, and projected returns, allowances and other standard adjustments, of the
product that is the subject of the offers (the “Forecast”). The Valuation Specialist shall make a determination of the net present value to LEO of WCCI’s offer and the Bona Fide Offer based on a discounted cashflow analysis
within 15 days after its engagement by WCCI and LEO; provided that, for WCCI’s Offer and the Bona Fide Offer, the Valuation Specialist shall assume (i) the net sales and components of its calculation set forth in the Forecast (to be
applied equally to WCCI’s offer and the Bona Fide Offer), and (ii) such other matters as the Parties and such Valuation Specialist deem relevant. Such determination of the net present values (the “Valuation Report”) shall
be delivered in writing to WCCI and LEO within such 15 day period and shall be final and binding on, and nonappealable by, WCCI and LEO, it being understood that the Valuation Report shall contain no information with respect to the identity of the
third party making the Bona Fide Offer or the terms of the Bona Fide Offer other than the net present value of 

  

			
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 such offer. WCCI and LEO shall each pay one-half the costs incurred in connection with the engagement of
the Valuation Specialist under this Article 2. The cash-flows shall be discounted with an interest rate of 10% p.a. Within thirty (30) days after receipt of the Valuation Report, WCCI shall have the right to make an offer having
the same net present value as the Bona Fide Offer (a “Matching Offer”) and LEO shall accept WCCI’s offer. If WCCI does not make a Matching Offer, LEO is free to accept the Bona Fide Offer and, subject to Article 2.5,
shall have no obligations towards WCCI with regard to such product. If WCCI makes a Matching Offer, WCCI and LEO shall exclusively negotiate in good faith the terms of a written agreement for the license of the product for a period of ninety
(90) days from the date of WCCI’s Matching Offer. 
  

	2.4	If after expiration of the ninety (90) day negotiation period, despite good faith negotiations, WCCI and LEO have not entered into final written agreement(s), LEO shall have
the right, subject to Article 2.5, at any time thereafter to sell or license the product to any third party. 

  

	2.5	In the event that (a) WCCI does not make a Matching Offer or (b) WCCI and LEO have not entered into final written agreements for a Non D/DC Derm Product within 90 days as
set forth in Article 2.4, prior to entering into any definitive written agreement with any third party for the sale or license of such product, LEO shall cause the Valuation Specialist to provide WCCI with the final net present value
(calculated in accordance with the cash flow analysis procedures set forth in Article 2.3) of any such sale or license to a third party. In no such event shall LEO sell or license such product to any third party on terms and conditions that
have a net present value that is less than the net present value of the last offer made by WCCI to LEO in writing. 

  

	2.6	With respect to the foregoing, LEO shall act in good faith when determining whether a product is developed “principally for the treatment or prevention of dermatological
diseases.” For example, WCCI should be permitted to offer to license from LEO the product LEO 15520 for its dermatological use if such compound is developed as a separate product for psoriasis, i.e. with its own NDA or supplement to an NDA,
dosage regimen, packaging and tradename. 

  

	2.7	If WCCI is notified prior to the end of Phase II trial (proof of concept) with respect to a Territory Product, WCCI may elect to negotiate an agreement for LEO to complete a Phase I
trial or Phase II trial, as the case may be, and shall have an exclusive option to license such product until Phase II (proof of concept) is complete, or earlier. Once Phase II (proof of concept) is complete, the procedures set forth in Articles
2.1 – 2.5 above with respect to negotiation of a license agreement shall apply. If upon receipt of a notice from LEO, WCCI elects not to negotiate a development or option agreement, LEO is free to offer such product to any third party at
any time and shall have no further obligations towards WCCI with regard to such product. 

  

			
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	2.8	The right of first refusal described herein does not apply to the product referred to as “TD 1414” as this product has already been offered to WCCI and WCCI has decided
not to acquire any rights to this product. For the avoidance of doubt LEO is free to offer this product to any third party at any time on any conditions and WCCI shall have no rights regarding this product. 

  

	2.9	If WCCI is in material breach of any material agreement in force between WCCI and LEO at the time WCCI wishes to exercise any rights described herein, and such breach has continued
uncured for a period of sixty (60) days following receipt by WCCI of notice of such breach from LEO, WCCI shall not have the right to exercise any such rights. 

 Article 3 
 Co-promotion 
  

	3.1	If a Non D/DC Derm Product is licensed to WCCI, LEO may make a request to co-promote the product in the Territory through a company owned or controlled by LEO in the Territory. Upon
such request, WCCI and LEO shall meet in good faith to discuss a possible co-promotion arrangement regarding the licensed product; provided that if LEO is permitted to co-promote the product, WCCI shall book the sales with respect to such
product. The terms of any co-promotion arrangement shall be mutually agreed by the Parties. 

 Article 4 
 Development activities 
  

	4.1	LEO shall use commercially reasonable efforts to perform its development activities regarding the Non D/DC Derm Products in good faith as promptly as practicable and in no event
shall LEO delay the development of a Non D/DC Derm Product for the purpose of preventing WCCI from exercising its rights hereunder. 

  

	4.2	The Parties shall from time to time and at least on a semi-annual basis meet and review the development efforts and plans with respect to such Non D/DC Derm Products. During such
meetings (and at such other times as LEO determines in good faith is necessary or appropriate), LEO shall update WCCI regarding the status of its efforts to obtain sublicensing rights with respect to Non D/DC Derm Products that are or may be
in-licensed by LEO from a third party. The Parties shall discuss such efforts in good faith, including the economic feasibility of such licenses/sublicenses in the Territory. 

  

			
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 Article 5 
 Confidentiality 
  

	5.1	The confidentiality provisions of the Confidentiality Agreement (excluding Article 9 of the Confidentiality Agreement – Governing Law and Venue) are hereby incorporated by
reference in this Agreement and are hereby deemed to be part of this Agreement. Notwithstanding anything to the contrary set forth in the Confidentiality Agreement, WCCI and its affiliates may disclose Confidential Information (as defined in the
Confidentiality Agreement) relating to this Agreement, including without limitation the existence and terms of this Agreement (i) in a filing with the United States Securities and Exchange Commission (the “SEC”) or any securities
exchange if such disclosure is required pursuant to applicable law or regulation, (ii) to any third party if such Confidential Information is part of a report of the information that would be required to be contained in a report on Form 8-K, a
quarterly report on Form 10-Q or an annual report on Form 10-K if WCCI were required to file such form with the SEC, or (iii) to a third party on a confidential basis if such disclosure is otherwise required pursuant to (x) the Credit
Agreement dated as of January 18, 2005 among Warner Chilcott Holdings Company III, Limited and certain of its subsidiaries, Credit Suisse First Boston and the other lenders party thereto or (y) the Indenture dated as of January 18,
2005 between Warner Chilcott Corporation and Wells Fargo Bank, National Association; provided that WCCI shall provide LEO with a copy of the Confidential Information relating to this Agreement that will be disclosed in advance of such
disclosure (other than this Agreement itself). 

  

	5.2	For the avoidance of doubt also the existence and terms of this Agreement are regarded as Confidential Information. 

 Article 6 
 Term and termination

  

	6.1	This Agreement shall become effective when signed by both Parties provided that the Master Agreement shall not have been terminated and the agreements mentioned in Article 7.1 of
the addendum to the Master Agreement are executed by the Parties on the date hereof. 

  

	6.2	This Agreement shall continue in full force and effect as provided herein, unless modified or terminated in accordance with any of the provisions hereof, until the earlier of
(i) the expiration or termination of the Master Agreement and (ii) 31 December 2010. 

  

	6.3	In the event that one of the Parties hereto materially defaults or breaches any of the provisions of this Agreement, the other Party shall have the right to terminate this Agreement
upon sixty (60) days’ written notice, provided, however, that if the Party in default within the sixty day period referred to, remedies the said default or breach, this Agreement shall continue in full force and effect.

  

			
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	6.4	In the event that one of the Parties hereto enters into liquidation whether compulsorily or voluntarily (otherwise than for the purposes of amalgamation or reconstruction),
compounds with its creditors, has a receiver or manager appointed in respect of all or any part of its assets, or is the subject of an application for an administration order or undergoes any analogous or similar act or proceeding under the laws of
any other jurisdiction in consequence of debt the other Party shall have the right to terminate this Agreement with immediate effect by written notice. 

 Article 7 
 Assignability 
  

	7.1	This Agreement shall be binding upon, and shall inure to the benefit of successors of the Parties hereto, or to any assignee of all of the goodwill and entire business assets of a
Party hereto relating to pharmaceuticals, but shall not otherwise be assignable without the prior written consent of the other Party. 

 Article 8 
 Amendment of Agreement; Waiver; Severability 
  

	8.1	This Agreement shall not be changed or modified orally. 

  

	8.2	Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a
written instrument duly executed by or on behalf of the Party waiving such term or condition. No waiver by either Party of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the
same or any other term or condition of this Agreement on any future occasion. All remedies, either under this Agreement or by Law or otherwise afforded, will be cumulative and not alternative. 

  

	8.3	If any provision of this Agreement is held to be illegal, invalid or unenforceable under any applicable present or future Law, and if the rights or obligations of any Party hereto
under this Agreement will not be materially and adversely affected thereby, (a) such provision will be fully severable, (b) this Agreement will be construed and enforced as if such illegal, invalid or unenforceable provision had never
comprised a part hereof, (c) the remaining provisions of this Agreement will remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such
illegal, invalid or unenforceable provision, the Parties will add as a part of this Agreement, a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible.

  

			
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 Article 9 
 Status of prior agreements 
  

	9.1	This Agreement constitutes the entire agreement between the Parties hereto with respect to the within subject matter and supersedes all previous agreements, whether written or oral.

 Article 10 
 Force Majeure 
  

	10.1	The occurrence of an event which materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the
Party affected, not due to malfeasance, and which could not with the exercise of due diligence have been avoided (“Force Majeure”) including, but not limited to, fire, accident, labor difficulty, strike, riot, civil commotion, act
of God, delay or errors by shipping companies or change in Law shall not excuse such Party from the performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of Force Majeure.
The Party prevented from performing its obligations or duties because of Force Majeure shall promptly notify the other Party hereto (the “Other Party”) of the occurrence and particulars of such Force Majeure and shall provide the
Other Party, from time to time, with its best estimate of the duration of such Force Majeure and with notice of the termination thereof. The Party so affected shall use its best efforts to remove or ameliorate such causes of non-performance. Upon
termination of Force Majeure, the performance of any suspended obligation or duty shall promptly recommence. Neither Party shall be liable to the Other Party for any direct, indirect, consequential, incidental, special, punitive or exemplary damages
arising out of or relating to the suspension or termination of any of its obligations or duties under this Agreement by reason of the occurrence of Force Majeure. In the event that Force Majeure has occurred and is continuing for a period of at
least six (6) months, the Other Party shall have the right to terminate this Agreement upon thirty (30) days’ notice. 

 Article 11 
 Partnership/Agency; Third Parties 
  

	11.1	None of the provisions of this Agreement shall be deemed to constitute the relationship of partnership or agency between the Parties, and neither Party shall have any authority to
bind the other Party in any way except as provided in this Agreement. 

  

	11.2	The Parties agree that no third party which is not a party to this Agreement is intended to benefit from or shall have any right to enforce any provision of this Agreement.

  

			
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 Article 12 
 Governing Law 
  

	12.1	THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED ENTIRELY WITHIN
SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW PRINCIPLES OF SUCH STATE OTHER THAN SECTION 5-1401 OF THE NEW YORK GENERAL OBLIGATIONS LAW. 

  

	12.2	Each Party irrevocably submits to the exclusive jurisdiction of (a) the Supreme Court of the State of New York, New York County, and (b) the United States District Court
for the Southern District of New York, for the purposes of any suit, action or other proceeding arising out of this Agreement or any transaction contemplated hereby or thereby. Each Party agrees to commence any such action, suit or proceeding either
in the United States District Court for the Southern District of New York or if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each
Party further agrees that service of any process, summons, notice or document by registered mail to such Party’s respective address set forth above shall be effective service of process for any action, suit or proceeding in New York with
respect to any matters to which it has submitted to jurisdiction in this Article 12. Each Party irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement or the
transactions contemplated hereby and thereby in (i) the Supreme Court of the State of New York, New York County or (ii) the United States District Court for the Southern District of New York, and hereby and thereby further irrevocably and
unconditionally waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. 

  

	12.3	Each Party hereto hereby waives to the fullest extent permitted by applicable Law, any right it may have to a trial by jury in respect to any litigation directly or indirectly
arising out of, under or in connection with this Agreement. 

  

			
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 Article 13 
 Notices 
  

	13.1	Any notice hereunder shall be deemed to be sufficiently given if sent by registered mail or by fax followed by mail to: 

 In the case of WCCI: 
 WARNER CHILCOTT COMPANY, INC. 
 Att. Director, Business Management 
 P.O. Box 1005 
 Fajardo, Puerto Rico 00738 
 Fax: + 1 787 863 5355 
 With a copy to: 
 Senior Vice
President and General Counsel 
 Warner Chilcott 
 100 Enterprise Drive 
 Rockaway, New Jersey 07866 
 Fax: + 1 973 442 3310 
 In the case of LEO: 
 LEO
Pharma A/S 
 Att. CEO, President 
 Industriparken 55 
 DK-2750 Ballerup 
 Denmark 
 Fax: + 45 72 26 32 95 
 or
such other address as the receiver shall have last furnished to the sender. 
  

			
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 IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly executed in duplicate by their
authorised officers as of the date last below written. 
  

									
	WARNER CHILCOTT COMPANY, INC.	  		  	LEO PHARMA A/S
			
	 /s/ Max Torres
	  		  	 /s/ Ernst Lunding

	Name:	 	Max Torres	  		  	Name:	  	Ernst Lunding
	Title:	 	Director, Business Management	  		  	Title:	  	President, CEO
					
	Date:	 	14 September 2005	  		  	Date:	  	14 September 2005

  

			
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