Development, Option and License Agreement



 Exhibit 10.1 
  
 DEVELOPMENT, OPTION AND LICENSE AGREEMENT 
  
 THIS DEVELOPMENT, OPTION AND LICENSE
AGREEMENT (the “Agreement”) is entered into as of the 15th day of May, 2003 (the “Effective Date”), by and between POZEN INC., a Delaware corporation, located
at 1414 Raleigh Road, Suite 400, Chapel Hill, NC 27517 on behalf of itself and its Affiliates (collectively “POZEN”), and NYCOMED DANMARK APS, a Danish corporation, located at
Langebjerg 1, DK-4000 Roskilde, Denmark on behalf of itself and its Affiliates (collectively “Nycomed”). POZEN and Nycomed are referred to in this Agreement individually as a “Party” and collectively as
“Parties.” 
  
 RECITALS 
  
 A. Nycomed and POZEN are engaged in the development, production, and
commercialization of pharmaceutical products and possess information and technology relating to the manufacture, use, and formulation of such products. 
  
 B. POZEN desires to obtain the right to perform research based upon certain proprietary information owned or controlled by Nycomed, and the option
to license certain intellectual property and proprietary information of Nycomed for the development and commercialization of certain pharmaceutical products upon the terms and conditions set forth in this Agreement. 
  
 C. Nycomed desires to grant such research rights and option to POZEN
upon the terms and conditions set forth in this Agreement. 
  
 D. The Parties desire to enter into an arrangement for the supply of active drug substance for use in the commercial manufacture of certain pharmaceutical products developed by POZEN pursuant to this Agreement. 
  


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 AGREEMENT 
  

In consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, the Parties agree as follows: 
  
 1. DEFINITIONS

  
 The capitalized terms used in this Agreement will have
the meanings given to them in this Section 1 and throughout this Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular. 
  
 1.1 “Affiliate” means a corporation or other business entity
which, (i) directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with either POZEN INC. or Nycomed Danmark ApS, and (ii) from time to time either POZEN INC. or Nycomed Danmark ApS
respectively desires to involve in the performance of this Agreement, and POZEN INC. will so involve any such corporation or other business entity, which has, either directly or indirectly, any requirements of LX Bulk Drug Substance or Lornoxicam
(or any salts, solvates or polymorphs thereof) for the purposes provided for under Section 7.1 of this Agreement. Each of POZEN INC. and Nycomed Danmark ApS will notify the other in writing if and as soon as it desires to involve any such
corporation or other business entity in the performance of this Agreement and Nycomed Danmark ApS hereby notifies POZEN INC. that it will so involve Nycomed Austria GmbH, St. Peter-Straße 25, A-4020 Linz, Austria. For purposes of this
definition only, “control” and, with corresponding meanings, the terms “controlled by” and “under common control with” means: (a) the possession, directly or indirectly, of the power to direct the management or
policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other
ownership interest of a legal entity. 
  
 1.2
“Buyer” means each of POZEN and Sublicensees. 
  
 1.3 “cGMP” means current good manufacturing practices for medicinal products established by regulations in the United States (including 21 CFR §§ 210 and 211, and, with respect to any Nycomed Product and placebo
used in clinical trials, subject to the FDA’s March 1991 Guideline on the Preparation of Investigational New Drug Products, each as amended, and any successor regulations thereto), and the corresponding rules, regulations, or guidelines in the
European Union and Canada. 
  


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 1.4 “Combination Product” means a pharmaceutical product containing Lornoxicam (or any
salts, solvates or polymorphs thereof) as an active drug substance in combination with one or more additional active drug substances, and (a) developed or manufactured by or on behalf of POZEN or Sublicensees using or referencing the Licensed
Technology or any part thereof, or (b) the use, manufacture or sale of which would, but for the licenses granted herein, infringe any Licensed Patents or intellectual property right other than Patents included in the Licensed Technology.

  
 1.5 “Commercialization” means the marketing,
promotion, advertising, selling or distribution for sale of a POZEN Product in a country after Marketing Approval has been obtained in such country. The term “Commercialize” has a corresponding meaning. 
  
 1.6 “Commercially reasonable efforts” means, with
respect to a Party, those efforts, consistent with the exercise of prudent scientific and business judgment, to conduct a particular activity hereunder that would be applied to a similar activity conducted by other companies in the pharmaceutical
industry, and, if related to the development or Commercialization of POZEN Products, those efforts, consistent with the exercise of prudent scientific and business judgement, to conduct a particular activity hereunder that would be applied to a
similar activity conducted by other companies in the pharmaceutical industry with respect to other pharmaceutical products of similar economic potential, risk and market size. 
  
 1.7 “Control” means, with respect to an entity and any Know-How, Patent or intellectual property right
other than Patents, that such entity owns a transferable interest in or has a license or sublicense (for so long as such license or sublicense is in effect) to practice such Patent, right or Know-How and has the ability to grant another entity
access, a license, or a sublicense (as applicable) to practice such Patent, right or Know-How without breaching an agreement with any Third Party and without imposing on such entity an obligation to make any payments to a Third Party as a result of
such grant of access, license or sublicense or the exercise thereof by such entity. 
  
 1.8 “Cost” means any direct and indirect costs incurred by Nycomed in connection with the manufacture, quality control or release of Nycomed Products or placebo, calculated in accordance with
international generally accepted accounting principles, consistently applied. 
  


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 1.9 “DMF” means a drug master file filed in accordance with 21 CFR 314.420 and
maintained with the FDA or the equivalent thereof, as applicable, in jurisdictions outside the United States. 
  
 1.10 “Exclusive Manufacturing Period” means, on a Buyer-by-Buyer basis: (a) with respect to the Exclusive Territory, the period
commencing on the Option Exercise Date and continuing until the date five years after: either (i) the date of first commercial sale of the first POZEN Product sold in the United States by such Buyer, if such Buyer’s territory to
Commercialize such POZEN Product includes both the United States and Canada, or (ii) otherwise, the date of first commercial sale of the first POZEN Product sold anywhere in the Exclusive Territory by such Buyer; and (b) with respect to
the Limited Territory, the period commencing on the Option Exercise Date and continuing until the date five years after: either (i) the date of first commercial sale of the first Combination Product sold in the United Kingdom, France or Germany
by such Buyer, if such Buyer’s territory to Commercialize such Combination Product includes one or more of those three countries; or (ii) otherwise, the date of first commercial sale of the first Combination Product sold anywhere in the
Limited Territory by such Buyer. 
  
 1.11 “Exclusive
Territory” means the United States (including the following territories and possessions: American Samoa, Commonwealth of Northern Marianas, Guam, Micronesia, Puerto Rico, U.S. Virgin Islands) and Canada. 
  
 1.12 “Existing Nycomed Products” means the pharmaceutical
products which were developed by Nycomed and for which Nycomed filed for Marketing Approval prior to the Effective Date or which Nycomed commercialized prior to the Effective Date, containing Lornoxicam as the single active drug substance, a
complete list of which is included as Exhibit A to this Agreement, attached hereto and hereby incorporated in this Agreement by reference, but excluding the products listed thereon as exceptions. 
  
 1.13 “Existing Nycomed Product Deliverables” means the
materials listed in Exhibit B to this Agreement (attached hereto and hereby incorporated in this Agreement by reference) in such quantities as set forth in Exhibit B and conforming to the applicable Specifications. 
  


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 1.14 “FDA” means the United States Food and Drug Administration, or any successor
agency. 
  
 1.15 “Field” means the diagnosis,
treatment, and prevention of human diseases and conditions. 
  
 1.16 “IND” means an investigational new drug application filed with the FDA. 
  
 1.17 “IND Deliverables” means the materials listed in Exhibit C and Schedule C-1 to this Agreement (attached hereto and
hereby incorporated in this Agreement by reference). 
  
 1.18
“Initial Development Program” has the meaning set forth in Section 2.2 of this Agreement. 
  
 1.19 “Invention” means any invention or discovery, whether or not patentable, conceived or reduced to practice by or on behalf of POZEN
or Sublicensees in connection with this Agreement or a Sublicense Agreement. 
  
 1.20 “Isomer Product” means a pharmaceutical product containing an isomer of Lornoxicam as either the single active drug substance or as an active drug substance in combination with one or more other
active drug substances, developed solely by Nycomed, and for which Nycomed files an IND or equivalent filing in the Exclusive Territory within ********* of the Effective Date. 
  
 1.21 “Know-How” means all non-public inventions, data, information, methods, procedures and processes
relating to the manufacture, development, testing or use of a Nycomed Product or POZEN Product, including but not limited to, biological, chemical, biochemical, toxicological, pharmacological, metabolic, formulation, clinical, analytical and
stability information and data (other than such Know-How which is or becomes the subject of a Patent). 
  
 1.22 “Latent Defect” means any failure of a shipment of Materials or portion thereof to conform at the date of delivery to the Product
Warranty 
  


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 (as defined in Section 8.1) that would not be discoverable prior to the deadline for notice of rejection under
Section 8.4.1(a) upon reasonable physical inspection or standard testing of such Materials in accordance with standards in the pharmaceutical industry, including in any event testing for purity and assay according to the methods included in the
applicable Specifications. 
  
 1.23 “Licensed
Patents” means the Patents listed on Exhibit G attached to this Agreement and hereby incorporated in this Agreement by reference. 
  
 1.24 “Licensed Technology” means any Know-How, Licensed Patents and intellectual property right other than Patents relating to the
Nycomed Products and Controlled by Nycomed in the Exclusive Territory or the Limited Territory, as applicable, but excluding, in any event, (i) any Know-How, Patents, intellectual property right other than Patents Controlled by Nycomed that are
related to the Process or to any other manufacturing process for LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof), and (ii) any trademark, trade name and trade dress of Nycomed and any Nycomed-specific
packaging. 
  
 1.25 “Limited Territory” means the
following countries: all member states of the European Union as of the Effective Date (excluding Spain, Portugal, and Italy), Armenia, Azerbaijan, Belarus, Estonia, Georgia, Iceland, Kazakhstan, Kyrgyzstan, Latvia, Liechtenstein, Lithuania, Moldova,
Norway, Russia, Switzerland, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan. 
  
 1.26 “Lornoxicam” means the active drug substance known as lornoxicam, having the chemical structure set forth in Exhibit D to this Agreement (attached hereto and hereby incorporated in this
Agreement by reference). 
  
 1.27 “LX Bulk Drug
Substance” means Lornoxicam in bulk form, conforming to the applicable Specifications (as hereinafter defined). 
  
 1.28 “MAA” means any marketing authorization application submitted to the appropriate regulatory authorities to obtain approval for the
marketing of a pharmaceutical product in any country of the European Union and any corresponding submissions in any other country of the Territory, except the United States. 
  


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 1.29 “Manufacturing Approval” means all filings, applications, licenses, permits, and
other authorizations which are required for the manufacture of the Materials in compliance with applicable laws and regulations of the country of manufacture. 
  

1.30 “Marketing Approval” means (i) approval of an NDA or the approval of an MAA; and (ii) any pricing and reimbursement
approvals in any country of the Territory, to the extent the applicable regulatory authorities in such country require a pricing or reimbursement approval prior to commercialization of a pharmaceutical product in such country. 
  
 1.31 “Materials” means any Nycomed Product, placebo, or LX
Bulk Drug Substance supplied by Nycomed to POZEN under this Agreement. 
  
 1.32 “NDA” means a new drug application submitted to the FDA to obtain FDA approval for the marketing of a pharmaceutical product in the United States. 
  
 1.33 “Net Sales” means with respect to any POZEN Product, the gross amount invoiced by POZEN or
Sublicensees to Third Party customers for the sale of such POZEN Product, less: (i) ******** and ******** to such Third Party customers for ******** and ******** POZEN Products; (ii) the amounts of ******** and ******** on account of the
purchase of POZEN Products; (iii) ******** and ******** or ******** in connection with the sales of a POZEN Product to any Third Party customer; (iv) ******** and ******** to Third Party customers, including, but not limited to, ********
or other Third Party customers who ******** for a POZEN Product; (v) any ******** made to ******** with respect to sales of POZEN Products in order to ********, and any ********* made by POZEN to any ********* for *********;
(vi) *********, and ********* and other ********* charges ********* or ********* to the extent ********* as *********; and (vii) any amounts *********, in accordance with consistently applied accounting policies of POZEN; provided,
however, that if the right to commercialize a POZEN Product is licensed to a Sublicensee, “Net Sales” as used herein with respect to such POZEN Product and such Sublicensee will have the meaning set forth in the applicable Sublicense
Agreement with such Sublicensee, which definition will be substantially similar to the definition above. In any event, “Net Sales” excludes (a) *********, (b) *********, and (c) *********. 
  


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 1.34 “Nycomed Improvement Product” means any pharmaceutical product containing
Lornoxicam (including salts, solvates and polymorphs thereof) as the single active drug substance, developed solely by Nycomed, and: (a) for which Nycomed Controls all Know-How, Patents, and intellectual property rights other than Patents
claiming the composition of matter, use or formulation of such product, and (b) for which Nycomed files for Regulatory Approval after the Effective Date or which Nycomed first commercializes after the Effective Date, and (c) which is an
improvement (including a new dosage strength, dosage form, or indication) of an Existing Nycomed Product. 
  
 1.35 “Nycomed Improvement Product Deliverables” means the materials listed in Exhibit E to this Agreement (attached hereto and
hereby incorporated in this Agreement by reference) in such quantities as set forth in Exhibit E and conforming to the applicable Specifications. 
  
 1.36 “Nycomed IND” means the IND with file # 28,285, filed with the FDA on April 23, 1986 and withdrawn on August 05, 1997.

  
 1.37 “Nycomed Product” means any Existing
Nycomed Product or Nycomed Improvement Product. 
  
 1.38
“Nycomed Product Deliverables” means the Existing Nycomed Product Deliverables and the Nycomed Improvement Product Deliverables. 
  
 1.39 “Option” has the meaning set forth in Section 3.1 of this Agreement. 
  
 1.40 “Option Exercise Date” means the date upon which POZEN
provides Nycomed with the written notice of exercise described in Section 3.1 of this Agreement. 
  
 1.41 “Option Period” has the meaning set forth in Section 3.2 of this Agreement. 
  
 1.42 “Patent” means (a) all patents and patent
applications in any country or supranational jurisdiction and (b) any substitutions, divisions, continuations, continuations in part, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary protection
certificates and the like, and any provisional applications, of any such patents or patent applications. 
  


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 1.43 “POZEN Product” means any Combination Product or Single Entity Product. 

 
 1.44 “Process” means either the manufacturing process
used by Nycomed as of the Effective Date for the manufacture of the LX Bulk Drug Substance or such process as changed by Nycomed from time to time in accordance with Section 9.6 of this Agreement. 
  
 1.45 “Regulatory Approval” means any approvals and any
master files, establishment licenses, registrations or authorizations of any national, federal, state or local regulatory agency, department, bureau or other governmental entity necessary for the manufacture, use, storage, export, import, transport
or sale of a pharmaceutical product in a country or other regulatory jurisdiction (including Marketing Approvals and the filing of an IND or a DMF). 
  
 1.46 “Single Entity Product” means a pharmaceutical product containing Lornoxicam (or any salts, solvates or polymorphs thereof) as the
single active drug substance, and (a) developed or manufactured by or on behalf of POZEN or Sublicensees using or referencing the Licensed Technology or any part thereof, or (b) the use, manufacture or sale of which would, but for the
licenses granted herein, infringe any Licensed Patents or intellectual property right other than Patents included in the Licensed Technology. 
  
 1.47 “Specifications” means, with respect to Materials either, the specific chemical and physical properties pertaining to such Materials
set forth on Exhibit F (attached hereto and hereby incorporated in this Agreement by reference), or such properties changed by Nycomed from time to time in accordance with Section 9.6 of this Agreement. 
  
 1.48 “Sublicense Agreement” means any agreement in which a
Third Party is granted a sublicense under the licenses granted by Nycomed to POZEN in this Agreement, whether by POZEN or its sublicensee. 
  
 1.49 “Sublicensee” means any entity other than POZEN that is a party to a Sublicense Agreement. 
  


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 1.50 “Sublicense Revenues” means any amount received by POZEN from a Sublicensee
pursuant to a Sublicense Agreement as an upfront license fee or milestone payment. 
  
 1.51 “Term” has the meaning set forth in Section 16.1 of this Agreement. 
  
 1.52 “Territory” means the Exclusive Territory and the Limited Territory. 
  
 1.53 “Third Party” means any individual or entity other than POZEN INC., Nycomed Danmark ApS, and their
respective Affiliates. 
  
 2. INITIAL DEVELOPMENT PROGRAM 
  
 2.1 Re-Analysis of Carcinogenicity Data. Within 30 days after the
Effective Date, Nycomed will deliver to POZEN copies of all raw data and study reports generated by or on behalf of Nycomed in connection with the carcinogenicity studies conducted with Lornoxicam in rats and mice (collectively the
“Carcinogenicity Data”). Nycomed will ship such copies DDU (ICC Incoterms 2000) to a place of destination to be named by POZEN within 10 days after the Effective Date. POZEN and/or its consultants (for and on behalf of POZEN) will,
at POZEN’s expense, commence with re-analyzing the Carcinogenicity Data promptly after delivery of the Carcinogenicity Data to POZEN. POZEN will use commercially reasonable efforts to complete such re-analysis as soon as reasonably practicable.
POZEN will provide the results of such re-analysis to Nycomed upon completion thereof free of charge. Nycomed may use such results for its internal research and development purposes and will otherwise treat such results as Confidential Information
of POZEN subject to the terms and conditions set forth in Section 15 of this Agreement. 
  
 2.2 Scope of Initial Development Program. During the Option Period, POZEN will: conduct development work for POZEN Products, including, by way of example, formulation studies and clinical proof of concept
studies for POZEN Products, (b) use reasonable efforts to prepare and file an IND for a POZEN Product ********* the delivery by Nycomed to POZEN of the IND Deliverables and the Existing Nycomed Product Deliverables (excluding any additional
shipments thereof requested by POZEN pursuant to the delivery schedule set forth in Exhibit B), and (c) after acceptance of the IND, use reasonable efforts to perform such clinical 
  


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 studies for the POZEN Products as POZEN deems appropriate to determine its interest in exercising the Option (the
“Initial Development Program”). POZEN will perform the Initial Development Program at its own expense. Nycomed understands and agrees that POZEN will have the right to reference the Nycomed IND and to use the IND Deliverables for
the preparation and filing of new INDs for POZEN Products and the performance of the Initial Development Program. POZEN understands and agrees that the Nycomed IND ********* and that Nycomed will ********* such Nycomed IND in the future. POZEN
further agrees that it will provide Nycomed as soon as reasonably practicable with a copy of the table of contents of any IND filed during the Option Period by or on behalf of POZEN for any POZEN Product, which POZEN may redact to avoid disclosure
of the identity of the specific POZEN Product to which the IND relates. 
  
 2.3 Nycomed Deliverables. Nycomed will deliver, or use commercially reasonable efforts to deliver (as provided for in the applicable Exhibit), to POZEN at no charge the following materials for use in the Initial Development Program:
(a) the Existing Nycomed Product Deliverables, in accordance with the delivery schedule set forth in Exhibit B; (b) the Nycomed Improvement Product Deliverables (if any), in accordance with the delivery schedule set forth in
Exhibit E; and (c) the IND Deliverables, in accordance with the delivery schedule set forth in Exhibit C; provided, however, that in no event will Nycomed be obligated to supply POZEN with Nycomed Products or placebo for
use in any Phase III or IV clinical trials. For the avoidance of doubt, nothing in this Section 2.3 will be construed as requiring Nycomed to generate new data, documentation or any translations that may be needed by POZEN. The supply of
Materials included in the Nycomed Product Deliverables to POZEN by Nycomed pursuant to this Section 2.3 will be subject to the warranties, terms and conditions set forth in Section 8 of this Agreement. 
  
 2.4 Grant of Development License. Nycomed hereby grants to POZEN an
exclusive (even as to Nycomed), fully paid, royalty-free license, in the Field in the Exclusive Territory to use the Nycomed Product Deliverables and IND Deliverables to make, have made under contract, use, develop and have developed under contract
pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as the single active drug substance and pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as an active drug

  


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 substance in combination with one or more other active drug substances, in each case during the Option Period solely in
connection with the Initial Development Program. Nycomed hereby grants to POZEN an exclusive (except as to Nycomed or its licensees or sublicensees pursuant to subsections 4.2.4 and 4.2.5 of this Agreement), fully paid, royalty-free license, in the
Field in the Limited Territory to use the Nycomed Product Deliverables and IND Deliverables to make, have made under contract, use, develop and have developed under contract pharmaceutical products containing Lornoxicam (or any salts, solvates or
polymorphs thereof) as an active drug substance in combination with one or more other active drug substances during the Option Period solely in connection with the Initial Development Program. 
  
 2.5 Use of Nycomed Product. POZEN will provide Nycomed with advance
written notice of any clinical trials that POZEN intends to perform during the Initial Development Program to the extent that such trials would require the use or testing of Nycomed Products. POZEN will accompany each such notice with clinical trial
protocols for the relevant studies. POZEN, at its sole discretion, may redact the protocols submitted to Nycomed to avoid disclosure of the identity of the specific POZEN Product to which such studies relate. POZEN will not initiate any clinical
trial for which it has submitted protocols to Nycomed under this Section 2.5 prior to receipt of Nycomed’s approval; provided, however, that such approval will not be unreasonably withheld or delayed for more than 2 weeks following
receipt of such protocols by Nycomed, and Nycomed’s failure to respond to such protocols within 2 weeks of receipt thereof shall be deemed to constitute Nycomed’s approval of such protocols. 
  
 3. GRANT OF OPTION 
  
 3.1 Option. Nycomed hereby grants POZEN an exclusive option (the “Option”) during the Option Period
to license the Licensed Technology for the research, development and Commercialization of POZEN Products on the terms set forth in this Agreement. POZEN may exercise the Option during the Option Period by providing Nycomed with written notice
stating that POZEN exercises the Option. Upon exercise of the Option during the Option Period, POZEN will be entitled to fully use and exploit the license granted to POZEN in Section 4.1 of this Agreement. 
  


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 3.2 Option Period. The Option may be exercised by POZEN during a period commencing on the
Effective Date and ending on the earlier of: (a) the date 18 months following the date on which POZEN files the first IND for a POZEN Product, and (b) the date 24 months after delivery by Nycomed to POZEN of the Existing Nycomed Product
Deliverables (excluding any additional shipments thereof requested by POZEN pursuant to the delivery schedule set forth in Exhibit B) and IND Deliverables (the “Option Period”). 
  
 3.3 Exclusivity. During the Option Period, Nycomed will not negotiate,
offer, enter into, or otherwise discuss with any Third Party any agreement that would prevent Nycomed from granting the rights or performing the obligations set forth in this Agreement in case that POZEN exercises the Option during the Option
Period. 
  
 4. LICENSES AND OTHER RIGHTS 
  
 4.1 License Grants to POZEN. 
  
 4.1.1 Subject to exercise of the Option by POZEN during the Option
Period, and subject to the terms set forth in Section 4.2 below, Nycomed grants to POZEN, and POZEN accepts, an exclusive (even as to Nycomed), royalty-bearing license, with the right to grant sublicenses, under the Licensed Technology to
develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as the single active drug substance and pharmaceutical
products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as an active drug substance in combination with one or more other active drug substances in the Exclusive Territory in the Field. 
  
 4.1.2 Subject to exercise of the Option by POZEN during the Option
Period, and subject to the terms set forth in Section 4.2 below, Nycomed grants to POZEN, and POZEN accepts, an exclusive (except as to Nycomed or its licensees or sublicensees pursuant to subsections 4.2.4 and 4.2.5 of this Agreement),
royalty-bearing license, with the right to grant sublicenses, under the Licensed Technology to develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam (or any
salts, solvates or polymorphs thereof) as an active drug substance in combination with one or more other active drug substances in the Limited Territory in the Field. 
  


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 4.1.3 Subject to exercise of the Option by POZEN during the Option Period, and subject to the
terms set forth in Section 4.2 below, Nycomed grants to POZEN, and POZEN accepts, an exclusive (even as to Nycomed), royalty-bearing license, with the right to grant sublicenses, under the Licensed Technology to make and have made under
contract pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as the single active drug substance and pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as an active
drug substance in combination with one or more other active drug substances for the Field in the Exclusive Territory. 
  
 4.1.4 Subject to exercise of the Option by POZEN during the Option Period, and subject to the terms set forth in Section 4.2 below, Nycomed
grants to POZEN, and POZEN accepts, a non-exclusive, royalty-bearing license under the Licensed Technology, with the right to grant sublicenses, to make and have made under contract pharmaceutical products containing Lornoxicam (or any salts,
solvates or polymorphs thereof) as the single active drug substance and pharmaceutical products containing Lornoxicam (or any salts, solvates or polymorphs thereof) as an active drug substance in combination with one or more other active drug
substances for the Field outside the Exclusive Territory, excluding any country listed on Exhibit I. POZEN may request from Nycomed the expansion of the non-exclusive license granted in this Section 4.1.4 to any country listed on
Exhibit I, and any such request will not be unreasonably refused by Nycomed. 
  
 4.2 Limitations; Exclusivity. 
  
 4.2.1 POZEN understands and agrees that the licenses granted in Section 4.1 of this Agreement are not granted and may not be used prior to the exercise of the Option by POZEN. 
  
 4.2.2 Notwithstanding the limited geographical scope of the license
granted to POZEN in Section 4.1.1 of this Agreement with respect to Single Entity Products, POZEN will have: (a) the right to use Single Entity Products or Nycomed Products in clinical comparison studies with 
  


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 Combination Products in the Limited Territory in the Field if such studies are required by regulatory agencies to obtain
Marketing Approval to Commercialize such Combination Product in one or more countries in the Limited Territory, and (b) the right to reference any MAA filed by Nycomed for Nycomed Products in the Field in the Limited Territory in a filing for
Marketing Approval to Commercialize such Combination Product in one or more countries in the Territory. 
  
 4.2.3 Nycomed will not itself or through any Third Party (whether through the grant of a license or otherwise): (a) conduct in the Field
pre-clinical tests in animals or clinical trials in humans with, or commercialize pharmaceutical products containing Lornoxicam or any salts, solvates or polymorphs of Lornoxicam in the Exclusive Territory, regardless of whether Lornoxicam or such
salt, solvate or polymorph is the sole active drug substance contained therein or is combined with one or more other active drug substances, or (b) develop or commercialize pharmaceutical products containing Lornoxicam (or any salts, solvates
or polymorphs thereof) in combination with other active drug substances in the Field in the Limited Territory, except as set forth in Sections 4.2.4 and 4.2.5 below. 
  
 4.2.4 Nycomed will retain the right to use the Licensed Technology to develop, have developed under contract by a
contract research organization, make, have made under contract by a contract manufacturer, use, offer to sell, sell, have sold, import and distribute in the Field in the Limited Territory pharmaceutical products containing Lornoxicam (or any salts,
solvates or polymorphs thereof) in combination with one or more additional active drug substances, and to license such products, including the Licensed Technology, to Third Parties in the Limited Territory; provided, however, that Nycomed
will not license any such product to any Third Party prior to *********. The retention of rights set forth in this Section 4.2.4 is not, and will not be construed as, a grant by POZEN to Nycomed of any right or license with respect to
Combination Products. 
  
 4.2.5 Nycomed will retain the
right to license from one or more Third Parties the right to develop, have developed under contract by a contract research organization, make, have made under contract by a contract manufacturer, use, offer to sell, sell, have sold, import and
distribute in the Limited Territory in the Field products containing Lornoxicam (or any salts, solvates or polymorphs thereof) in combination 
  


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 with one or more additional active drug substances, and to sublicense any such product, including the Licensed
Technology, to Third Parties in the Limited Territory; provided, however, that Nycomed will not license any such product to any Third Party prior to *********. 
  
 4.2.6 POZEN will have the right to sublicense any of the rights and licenses granted to POZEN pursuant to Sections
4.1 and 4.2.2 of this Agreement and its right to reference DMFs pursuant to Section 9.3 of this Agreement and to authorize POZEN’s Sublicensees to grant up to ********* of further sublicenses. 
  
 4.2.7 Promptly after execution of any Sublicense Agreement POZEN will
communicate to Nycomed the name and address of the applicable Sublicensee and provide Nycomed with the term and territory of the Sublicense Agreement. POZEN will further promptly communicate to Nycomed any major amendments to any Sublicense
Agreement, including any termination of any Sublicense Agreement prior to its expiration. 
  
 4.2.8 POZEN will ensure that no Sublicense Agreement or any term or condition thereof is inconsistent or conflicting with this Agreement or any term or condition thereof. 
  
 4.2.9 POZEN will ensure that all of its obligations under this
Agreement reasonably related to the rights and licenses sublicensed under a Sublicense Agreement to a Sublicensee will be passed to such Sublicensee, and POZEN will be responsible and liable for any breach of these obligations by such Sublicensee.
For purposes of clarification, POZEN will not be responsible or liable for any breach by a Sublicensee of a commercial supply agreement between Nycomed and such Sublicensee as set forth in Section 7.1 of this Agreement; provided, however,
that POZEN shall use commercially reasonable efforts to cause each Sublicensee to comply with its obligation to purchase its entire requirements of LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof) for use in
the manufacture of POZEN Products from Nycomed during the applicable Exclusive Manufacturing Period in accordance with Section 7.1 of this Agreement. 
  
 4.3 Option Grant to Nycomed. 
  
 4.3.1 Subject to Section 4.3.2, POZEN hereby grants to Nycomed, and Nycomed hereby accepts, a right of first refusal (the 
  


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 “Nycomed Option”) on the terms set forth in this Section 4.3 for an exclusive license, with the
right to grant sublicenses, under any applicable Patent, Know-How or intellectual property other than Patents Controlled by POZEN relating to a Combination Product to develop, have developed under contract, make, have made under contract, use, offer
to sell, sell, have sold, distribute and import any Combination Product in the Field within the following countries: Iceland, Denmark, Norway, Sweden, Finland, Lithuania, Latvia, Estonia, Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine (the “Nycomed Option Territory”). 
  
 4.3.2 The Nycomed Option will not apply with respect to any Combination Product that is claimed by a Patent or intellectual property other than
Patents, or that embodies Know-How, Controlled by a Third Party. With respect to each such Combination Product, POZEN will use good faith efforts to introduce Nycomed to such Third Parties from which POZEN has secured a license to such Patent or
intellectual property other than Patents or Know-How for the purpose of enabling Nycomed to negotiate a license to such Patent or intellectual property other than Patents or Know-How in the Nycomed Option Territory. If Nycomed is successful in
obtaining such a license, then the Nycomed Option will subsequently apply to each Combination Product for which a license was obtained. 
  
 4.3.3 With respect to each Combination Product, POZEN will notify Nycomed upon the earlier of: (a) *********, and (b) *********. Such
notice shall identify the active drug substances contained in the applicable Combination Product and the presentation form(s) thereof. After sending each such notice, POZEN will provide Nycomed in a due diligence meeting with: (1) access at
POZEN’s facilities to up-to-date pre-clinical and clinical data (including safety and stability data), the IND, reports available and other reasonably requested documentation relating to such Combination Product, and (2) a term sheet
setting forth terms and conditions under which POZEN proposes to grant Nycomed an exclusive license to such Combination Product in the Nycomed Option Territory, which may include, without limitation, commercially reasonable upfront payments,
milestone payments and royalties payable to POZEN for a license to the applicable Combination Product. 
  


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 4.3.4 The period during which Nycomed may exercise the Nycomed Option will commence upon receipt
by Nycomed of the notice described in Section 4.3.3 of this Agreement and terminate ********* after the due diligence meeting at POZEN’s facilities described in Section 4.3.3. The due diligence meeting at POZEN’s facilities
described in Section 4.3.3 will take place within ********* after receipt by Nycomed of such notice. 
  
 4.3.5 Nycomed may exercise the Nycomed Option with respect to a particular Combination Product by written notice to POZEN setting forth the
countries within the Nycomed Option Territory for which Nycomed desires to negotiate a license. If POZEN does not receive a notice of exercise of the Nycomed Option for a particular country within the Nycomed Option Territory during the *********
exercise period described in Section 4.3.4 of this Agreement, then POZEN will have the right to enter into licensing arrangements of the applicable Combination Product with Third Party licensees, or itself commercialize such Combination
Product, in each such country without further obligation to grant a license to Nycomed for such Combination Product in such countries. 
  
 4.3.6 Upon the exercise by Nycomed of the Nycomed Option with respect to a Combination Product in one or more countries within the Nycomed Option
Territory, Nycomed and POZEN will meet within ********* to negotiate in good faith an appropriate license agreement for up to ********* after such exercise. If the Parties have not executed a license agreement with respect to a particular country
within the Nycomed Option Territory as of the date ********* following Nycomed’s exercise of the Nycomed Option, then POZEN will have the right to enter into licensing arrangements of the applicable Combination Product with Third Party
licensees, or itself commercialize such Combination Product, in each such country without further obligation to grant a license to Nycomed for such Combination Product in such countries. 
  
 4.3.7 For the avoidance of doubt, nothing in this Section 4.3 will be construed as a Party’s acceptance of
any terms and conditions proposed by the other Party in a term sheet and none of such terms and conditions will be binding on such Party, and each Party will only be bound after full execution of an aforesaid license agreement. 
  
 4.3.8 If Nycomed participates in the due diligence meeting described
in Section 4.3.3 above with respect to a Combination Product but 
  


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 does not enter into a license agreement with POZEN as set forth in Section 4.3.6 with respect to such Combination
Product, then, during the Term, Nycomed will not commercialize any pharmaceutical product containing the same combination of active drug substances as the Combination Product for which Nycomed did not enter into such license agreement. 

 
 4.4 Isomer Option. 
  
 4.4.1 Subject to Section 4.4.2, Nycomed hereby grants to POZEN,
and POZEN hereby accepts, a right of first refusal (the “Isomer Option”) on the terms set forth in this Section 4.4 for an exclusive license, with the right to grant sublicenses, under any applicable Patent, Know-How or
intellectual property other than Patents, Controlled by Nycomed relating to any Isomer Product to develop, have developed under contract, make, have made under contract, use, offer to sell, sell, have sold, distribute and import such Isomer Product
in the Field in the Exclusive Territory. 
  
 4.4.2 The
Isomer Option will not apply with respect to any Isomer Product that is claimed by a Patent or intellectual property other than Patents, or that embodies Know-How, Controlled by a Third Party. With respect to each such Isomer Product that is claimed
by a Patent or intellectual property other than Patents, or that embodies Know-How, Controlled by a Third Party, Nycomed will use good faith efforts to introduce POZEN to such Third Parties from which Nycomed has secured a license to such Patent or
Know-How for the purpose of enabling POZEN to negotiate a license to such Patent or Know-How in the Exclusive Territory. If POZEN is successful in obtaining such a license, then the Isomer Option will subsequently apply to each Isomer Product
claimed by a Patent or intellectual property other than Patents, or embodying Know-How, Controlled by a Third Party for which a license was obtained. 
  
 4.4.3 With respect to each Isomer Product, Nycomed will notify POZEN upon the earlier of: (a) *********, and (b) *********. Such notice
shall identify the active drug substance(s) contained in the applicable Isomer Product and the presentation form(s) thereof. After sending each such notice, Nycomed will provide POZEN in a due diligence meeting with: (1) access at
Nycomed’s facilities to up-to-date pre-clinical and clinical data (including safety and stability data), the IND or equivalent filing, reports available and other reasonably requested documentation relating to such Isomer Product, and
(2) a term sheet setting forth terms and conditions 
  


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 under which Nycomed proposes to grant POZEN an exclusive license to such Isomer Product in the Field in the Exclusive
Territory, which may include, without limitation, commercially reasonable upfront payments, milestone payments and royalties payable to Nycomed for a license to the applicable Isomer Product. 
  
 4.4.4 The period during which POZEN may exercise the Isomer Option
will commence upon receipt by POZEN of the notice described in Section 4.4.3 of this Agreement and terminate ********* after the due diligence meeting at Nycomed’s facilities described in Section 4.4.3. The due diligence meeting at
Nycomed’s facilities described in Section 4.4.3 will take place within ********* after receipt by POZEN of such notice. 
  
 4.4.5 POZEN may exercise the Isomer Option with respect to a particular Isomer Product by written notice to Nycomed that POZEN desires to negotiate
a license. If Nycomed does not receive a notice of exercise of the Isomer Option during the ********* exercise period described in Section 4.4.4 of this Agreement, then Nycomed will have the right to enter into licensing arrangements of the
applicable Isomer Product with Third Party licensees, or itself commercialize such Isomer Product, in the Exclusive Territory without further obligation to grant a license to POZEN for such Isomer Product in the Exclusive Territory. 
  
 4.4.6 Upon the exercise by POZEN of the Isomer Option with respect to
an Isomer Product in the Exclusive Territory, POZEN and Nycomed will meet within ********* to negotiate in good faith an appropriate license agreement for up to ********* after such exercise. If the Parties have not executed a license agreement with
respect to such Isomer Product in the Exclusive Territory as of the date ********* following POZEN’s exercise of the Isomer Option, then Nycomed will have the right to enter into licensing arrangements of the applicable Isomer Product with
Third Party licensees, or itself commercialize such Isomer Product, in the Exclusive Territory without further obligation to grant a license to POZEN for such Isomer Product in the Exclusive Territory. 
  
 4.4.7 For the avoidance of doubt, nothing in this Section 4.4
will be construed as a Party’s acceptance of any terms and conditions proposed by the other Party in a term sheet and none of such terms and conditions will be binding on such Party, and each Party will only be bound after full execution of an
aforesaid license agreement. 
  


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 4.4.8 If POZEN participates in the due diligence meeting described in Section 4.4.3 above
with respect to an Isomer Product but does not enter into a license agreement with Nycomed as set forth in Section 4.4.6 with respect to such Isomer Product, then, during the Term, POZEN will not commercialize any pharmaceutical product
containing the same combination of active drug substances as the Isomer Product for which POZEN did not enter into such license agreement. 
  
 4.5 Negative Covenants. POZEN hereby covenants and agrees not to: (a) use Materials supplied by Nycomed under this Agreement for any other
purpose than expressly provided for under this Agreement, or (b) actively promote, market or sell Single Entity Products outside the Exclusive Territory, or (c) actively promote, market or sell Combination Products outside the Territory.

  
 5. DEVELOPMENT PROGRAM 
  
 5.1 Development and Costs. POZEN will be responsible for the
pre-clinical and clinical development of the POZEN Products, and will prepare and file all applications for Marketing Approval of POZEN Products, at POZEN’s expense. Nycomed will, throughout the Term, provide reasonable technical and scientific
support to assist POZEN in obtaining and maintaining Marketing Approvals in the Territory. POZEN will reimburse Nycomed for any internal costs (at then-standard FTE rates, up to ********* and per Nycomed employee engaged), pro-rated for any partial
day (based on an eight-hour day), and for reasonable and documented out-of-pocket expenses incurred by Nycomed in connection with such provision of support. Prior to initiating any particular technical and/or scientific support services requested by
POZEN under this Section 5.1, Nycomed shall provide to POZEN for its approval a good faith written estimate of its anticipated internal costs (including FTE rate(s) of Nycomed personnel who would provide such services) and out-of-pocket
expenses of providing such services, and if POZEN notifies Nycomed within ********* of receipt of such estimate that POZEN does not wish to incur such costs and expenses, Nycomed shall not provide such services unless otherwise agreed by the
Parties. 
  
 5.2 Supply of Materials. After the Initial
Development Program, Nycomed will use commercially reasonable efforts to deliver to POZEN, LX Bulk Drug Substance, which shall be provided at ********* for use in 
  


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 pre-clinical studies and clinical trials for POZEN Products in such quantities as may be reasonably requested by POZEN
from time to time. In addition, during a period of up to ********* from the Option Exercise Date, Nycomed will use commercially reasonable efforts to deliver to POZEN Nycomed Products and placebo, which shall be provided *********, in such
quantities as may be reasonably requested by POZEN from time to time; provided, however, that in no event will Nycomed be obligated to supply POZEN with Nycomed Products or placebo for use in any Phase III or IV clinical trials. 

 
 5.3 Order Process for Materials. To order Materials from Nycomed
pursuant to Section 5.2 above, POZEN will submit a purchase order to Nycomed specifying the amount of such Materials and the delivery date. Unless otherwise agreed by the Parties, Nycomed will not be required to supply Materials ordered by
POZEN if the delivery date set forth on the applicable purchase order for such Materials is less than ********* after the date of receipt of such purchase order by Nycomed. 
  
 5.4 Shipping. Nycomed will package and label the applicable Materials pursuant to Section 5.2 above for shipment
in accordance with applicable law and in accordance with Nycomed’s standard practices. Nycomed will ship the Materials DDU (ICC Incoterms 2000) to a place of destination named by POZEN in the applicable purchase order. Each shipment will be
made according to the schedule and in the amounts specified in the applicable purchase order and under the terms and conditions set forth in this Agreement. Should Nycomed at any time during the Term have reason to believe that it will be unable to
meet a delivery date of a shipment, Nycomed will promptly notify POZEN of the cause for such delay and the steps undertaken by Nycomed to avoid or minimize such delay. 
  
 5.5 Invoices. Nycomed will send an invoice to POZEN via facsimile upon shipment of Materials under this
Section 5 and will enclose such invoice with each shipment of Materials under this Section 5. Each such invoice will set forth a detailed account of the quantities and price of Materials included in such shipment. All invoices submitted to
POZEN by Nycomed under this Section 5.5 will be payable within ********* of the invoice date. 
  


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 5.6 Other Supply Provisions. The supply of Materials to POZEN by Nycomed pursuant to this
Section 5 will be subject to the warranties, terms and conditions set forth in Section 8 of this Agreement. 
  
 5.7 Use of Nycomed Product. POZEN will provide Nycomed with advance written notice of any clinical trials that POZEN intends to perform during the
pre-clinical and clinical development of POZEN Products to the extent that such trials would require the use or testing of Nycomed Products. POZEN will accompany each such notice with clinical trial protocols for the relevant studies. POZEN, at its
sole discretion, may redact the protocols submitted to Nycomed to avoid disclosure of the identity of the specific POZEN Product to which such studies relate. POZEN will not initiate any clinical trial for which it has submitted protocols to Nycomed
under this Section 5.7 prior to receipt of Nycomed’s approval; provided, however, that such approval will not be unreasonably withheld or delayed, and Nycomed’s failure to respond to such protocols within ********* of receipt
thereof shall be deemed to constitute Nycomed’s approval of such protocols. 
  
 5.8 Access to Know-How. During pre-clinical and clinical development of the POZEN Products, after the Initial Development Program, and upon ********* written notice by POZEN to Nycomed specifying the Know-How
to which POZEN would like access, Nycomed will grant POZEN, at Nycomed’s facilities and during such number of days per calendar year as POZEN reasonably requests (not to exceed a total of *********), access to Nycomed’s Know-How that is
available at Nycomed or its then-current contractors and included in the Licensed Technology. For the avoidance of doubt, nothing in this Section 5.8 will be construed as requiring Nycomed to generate new data, documentation or any
translations. 
  
 6. COMMERCIALIZATION 
  
 6.1 Principles of Commercialization. POZEN will be responsible for
Commercializing the POZEN Products in the Field in the Territory during the Term, *********. However, the Parties acknowledge and agree that POZEN may grant some of its responsibilities to Nycomed after execution of a license agreement contemplated
in Section 4.3 of this Agreement. 
  


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 6.2 Regulatory Obligations. POZEN will be responsible for all activities in connection with the
Regulatory Approvals for a POZEN Product in the Territory (other than the Manufacturing Approvals necessary for Nycomed’s manufacture of LX Bulk Drug Substance), including communicating and preparing and filing all reports with the applicable
regulatory authority. Nycomed will, throughout the Term, provide reasonable technical and scientific support to assist POZEN in preparing and filing such reports. POZEN will reimburse Nycomed for any internal costs (at then-standard FTE rates, up to
********* and per Nycomed employee engaged), pro-rated for any partial day (based on an eight-hour day), and for reasonable and documented out-of-pocket expenses incurred by Nycomed in connection with such provision of support. Prior to initiating
any particular technical and/or scientific support services requested by POZEN under this Section 6.2, Nycomed shall provide to POZEN for its approval a good faith written estimate of its anticipated internal costs (including FTE rate(s) of
Nycomed personnel who would provide such services) and out-of-pocket expenses of providing such services, and if POZEN notifies Nycomed within ********* of receipt of such estimate that POZEN does not wish to incur such costs and expenses, Nycomed
shall not provide such services unless otherwise agreed by the Parties. POZEN will pay all fees associated with filing, obtaining and maintaining such Regulatory Approvals. 
  
 6.3 Diligence. POZEN will use commercially reasonable efforts to develop (including preparing and filing applications
for and obtaining Regulatory Approvals) and to Commercialize at least one POZEN Product in the Field in the United States (excluding its territories and possessions), France, Germany and the United Kingdom as soon as reasonably practicable, and to
apply commercially reasonable efforts and resources to maximize sales of POZEN Products throughout the Territory, and at least equal to the efforts and resources normally used by POZEN for another pharmaceutical product owned by it that has a
similar market potential and is at a similar stage in its product life cycle as the applicable POZEN Product. If either (a) development of a POZEN Product ceases or (b) Regulatory Approval of a POZEN Product is granted in a particular
country in the Territory but POZEN does not launch such POZEN Product in such country as soon as reasonably practicable after Regulatory Approval, POZEN shall provide Nycomed with a reasonable explanation for such decision; provided, however,
that the foregoing obligation shall cease upon 
  


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 launch of the first POZEN Product in the United States (excluding its territories and possessions), France, Germany and
the United Kingdom (which need not be the same POZEN Product in all of such countries). 
  
 7. COMMERCIAL SUPPLY OF LX BULK DRUG SUBSTANCE 
  
 7.1 Exclusivity of Supply of LX Bulk Drug Substance. During the Exclusive Manufacturing Period(s) applicable to POZEN, POZEN will subject to Section 7.5 of this Agreement purchase from Nycomed and Nycomed will use commercially
reasonable efforts to provide to POZEN, 100% of POZEN’s requirements of LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof), to be provided by Nycomed in the form of LX Bulk Drug Substance, for use in the
manufacture of any POZEN Product. For purposes of clarification, for any POZEN Product manufactured after the applicable Exclusive Manufacturing Period, POZEN will have the right to source LX Bulk Drug Substance or Lornoxicam (or any salt, solvate
or polymorph thereof) from any entity. POZEN will ensure that either no Sublicense Agreement shall become effective unless and until the Sublicensee enters into a supply agreement with Nycomed in substantially the same form as the supply agreement
attached to this Agreement as Exhibit J (attached to this Agreement and incorporated in this Agreement by reference) or, at POZEN’s election, POZEN undertakes to purchase 100% of such Sublicensee’s requirements of LX Bulk Drug
Substance or Lornoxicam (or any salts, solvates or polymorphs thereof), to be provided by Nycomed in the form of LX Bulk Drug Substance, for use in the manufacture of any POZEN Product under the terms and conditions set forth in this Agreement for
supply to POZEN. Nycomed will use commercially reasonable efforts to enter into such a supply agreement with each Sublicensee, and POZEN will use commercially reasonable efforts to cause each Sublicensee to enter into such a supply agreement, as
promptly as practicable. In the event that a supply agreement between Nycomed and a Sublicensee is terminated for any reason other than material breach by Nycomed prior to the expiration of the applicable Exclusive Manufacturing Period(s), Nycomed
shall provide POZEN with written notice of such termination, and POZEN shall promptly terminate or cause the termination of such Sublicensee’s Sublicense Agreement with respect to the Licensed Technology or any portion thereof that is
sublicensed to such Sublicensee. For purposes of clarification, if a Sublicensee has entered into a supply agreement with Nycomed, POZEN, in its discretion, may supply such Sublicensee with all or any portion of such Sublicensee’s requirements
of LX Bulk Drug Substance, out of POZEN’s own stock of LX Bulk Drug Substance purchased from Nycomed. 
  


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 7.2 Optional Extension. The Parties may extend the Exclusive Manufacturing Period(s) applicable to
POZEN for successive one-year terms, upon terms to be agreed upon at such time by the Parties. 
  
 7.3 Optional Termination. On or after January 1, 2014, either Party may provide the other Party with written notice of its intention to terminate the supply of LX Bulk Drug Substance to POZEN by Nycomed
under this Agreement, in which case Nycomed’s obligation to supply POZEN with LX Bulk Drug Substance under this Section 7 will terminate on the date 24 months after the date such notice is received by such other Party. 
  
 7.4 Supply Diligence. 
  
 7.4.1 Nycomed will use commercially reasonable efforts to maintain a
reasonable inventory of LX Bulk Drug Substance, at Nycomed’s expense, for use in filling orders of LX Bulk Drug Substance conforming to the Specifications and as forecasted in the binding portion of a forecast by POZEN in accordance with this
Section 7, at Nycomed. Similarly, POZEN will use commercially reasonable efforts to maintain a reasonable inventory of LX Bulk Drug Substance supplied by Nycomed, at POZEN’s expense . 
  
 7.4.2 If Nycomed has reason to believe that it will be unable to
manufacture and fill a particular order made in accordance with this Section 7 of LX Bulk Drug Substance conforming to the Specifications despite the safeguards described in Section 7.4.1 above, then Nycomed will promptly notify POZEN of
the cause for such projected shortfall and POZEN will have the right pursuant to Section 7.5 of this Agreement to use an alternate source to supply the actual shortfall. 
  
 7.4.3 If Nycomed has reason to believe that it will be unable, on an ongoing basis, to manufacture and fill orders by
POZEN of LX Bulk Drug Substance conforming to the Specifications forecasted in accordance with this Section 7, then Nycomed will notify POZEN of the cause for such projected shortfall, and use commercially reasonable efforts to establish a
contract manufacturer to manufacture such shortfall for Nycomed for supply to POZEN. Nycomed will not retain any contract manufacturer of which Nycomed has reason to believe that it would be unable to manufacture LX 
  


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 Bulk Drug Substance in accordance with the Product Warranty (as defined in Section 8.1 of this Agreement). If
Nycomed has reason to believe that it will be unable to establish, or establish in due time, such a contract manufacturer and to have manufactured such projected shortfall, then Nycomed will promptly notify POZEN thereof and POZEN will then have the
right pursuant to Section 7.5 of this Agreement to use an alternate source to supply the greater of: (a) *********, and (b) *********, provided that POZEN shall use commercially reasonable efforts to *********. 
  
 7.5 Establishment of Alternate Source. 
  
 7.5.1 During the Exclusive Manufacturing Period(s) applicable to
POZEN, POZEN will have the right to manufacture or have manufactured and supplied to it LX Bulk Drug Substance for further processing into a POZEN Product by an alternate source to the extent Nycomed fails to supply POZEN’s requirement of LX
Bulk Drug Substance as described in Section 7.4; provided, however, that in no event will POZEN use any Patents Controlled by, or use or disclose Confidential Information of, Nycomed and related to the Process or to any other
manufacturing process for LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof). 
  
 7.5.2 If POZEN purchases from an alternate source a quantity of LX Bulk Drug Substance that Nycomed failed to supply as described above and if such
failure is related to *********, then, if the price paid by POZEN to such alternate source for such quantity of LX Bulk Drug Substance is *********, Nycomed will *********POZEN the ********* of the ********* the ********* ********* to the *********
and the *********, up to a ********* ********* to ********* of the *********. 
  
 7.6 Failure to Supply; End of Exclusive Manufacturing Periods. POZEN will have the right to terminate the Exclusive Manufacturing Period applicable to it: 
  
 (a) upon the failure of Nycomed to supply for any reason, excluding
force majeure, at least ********* of POZEN’s requirement of LX Bulk Drug Substance conforming to the Specifications forecasted and ordered in accordance with this Section 7 for *********, or for *********, in each case, unless Nycomed
remedies such shortfall either (i) within 30 days of the scheduled delivery date in the case of failure to deliver at least 
  


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 ********* of ordered quantities of LX Bulk Drug Substance, or (ii) in accordance with Section 8.4 in the case
of failure of at least ********* of such LX Bulk Drug Substance delivered to conform to the Specifications. The termination right set forth in this subsection (a) will expire with respect to a particular failure described above if not exercised
within 30 days of the expiration of Nycomed’s rights to remedy such failure; or 
  
 (b) upon the failure of Nycomed to supply for any reason, excluding force majeure, at least ********* of POZEN’s requirement of LX Bulk Drug Substance conforming to the Specifications forecasted and
ordered in accordance with this Section 7 during any calendar year, unless Nycomed remedies such shortfall either (i) within 30 days of the scheduled delivery date in the case of failure to deliver at least ********* of ordered quantities
of LX Bulk Drug Substance, or (ii) in accordance with Section 8.4 in the case of failure of at least ********* of such LX Bulk Drug Substance delivered to conform to the Specifications. The termination right set forth in this subsection
(b) will expire with respect to a particular failure described above if not exercised within 30 days of the expiration of Nycomed’s rights to remedy such failure. 
  
 7.7 Supply Price. All supply of LX Bulk Drug Substance by Nycomed to POZEN for further processing into POZEN Products
intended for commercial sale will be made at the prices set forth on the following table: 
  

			
	 Quantity of LX Bulk Drug Substance
     ordered by POZEN *********:    

	 	 Price per kg of LX Bulk Drug
                 Substance:                   
 


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

  
 By way of example, if POZEN orders, in
one or more orders during a calendar year, ********* of LX Bulk Drug Substance for delivery, the price for *********. 
  
 7.8 Price Increases. If any changes to cGMP or any changes to applicable laws or regulations are adopted after the Effective Date, and if

  


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 Nycomed’s compliance with such changed cGMP, laws or regulations will result in an increase in the direct
manufacturing costs of Nycomed for LX Bulk Drug Substance, then Nycomed will promptly inform POZEN and may reasonably increase the prices set forth in Section 7.6 of this Agreement; provided, however, if any such price increase would
lead to an increase of the prices set forth in Section 7.6 of this Agreement of ********* then POZEN will have the right to terminate any Exclusive Manufacturing Period applicable to POZEN within ********* from receipt of Nycomed’s
notification of such price increase. POZEN’s notice of termination shall become effective between ********* from receipt by Nycomed as specified in such termination notice (unless Nycomed reduces the price increase ********* and such price
change and the effective date thereof are communicated to POZEN within ********* of receipt of POZEN’s notice), provided that POZEN will continue to purchase LX Bulk Drug Substance during such period at the increased price and such increased
price will be subject to any further price increases that result from additional changes to cGMP, laws or regulations during such period. 
  
 7.9 Forecasts. No later than one calendar quarter prior to the beginning of the calendar quarter in which POZEN desires the first delivery of LX
Bulk Drug Substance from Nycomed under this Section 7 (the “Initial Quarter”), POZEN will provide Nycomed with a forecast setting forth POZEN’s requirements of LX Bulk Drug Substance for the 6 calendar quarters comprising
the Initial Quarter and the 5 subsequent calendar quarters. Thereafter, on or before the first business day of each calendar quarter following the calendar quarter in which the first forecast was provided by POZEN to Nycomed, POZEN will provide
Nycomed with an updated rolling 6-calendar-quarter forecast. The quantities of LX Bulk Drug Substance set forth for the first 2 calendar quarters set forth in any forecast will be binding on the Parties; provided, however, that the quantity
of LX Bulk Drug Substance set forth in the second calendar quarter in any forecast will be greater than 85%, and less than 115%, of the quantity of LX Bulk Drug Substance forecast for such calendar quarter in the previous forecast submitted by POZEN
under this Section 7.9. All quantities of LX Bulk Drug Substance set forth for the fourth through sixth calendar quarters in any forecast provided under this Section 7.9 are to be considered non-binding good faith estimates, and are
provided to Nycomed only for preliminary planning purposes. The following table provides an example of the forecasts described by this Section 7.9: 
  


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	 	 	 Forecast submitted
 on first business day,
             1Q2005            

	 	 Forecast submitted
 on first business day,
             2Q2005            


	 Quantity for delivery during 2Q2005
	 	 100kg
 (binding)
	 	 —  

			
	 Quantity for delivery during 3Q2005
	 	 200kg
 (binding)
	 	 200kg
 (binding)

			
	 Quantity for delivery during 4Q2005
	 	 300kg
 (non-binding)
	 	 300kg ± 15%
 (binding)

			
	 Quantity for delivery during 1Q2006
	 	 350kg
 (non-binding)
	 	 400kg
 (non-binding)

			
	 Quantity for delivery during 2Q2006
	 	 400kg
 (non-binding)
	 	 200kg
 (non-binding)

			
	 Quantity for delivery during 3Q2006
	 	 400kg
 (non-binding)
	 	 700kg
 (non-binding)

			
	 Quantity for delivery during 4Q2006
	 	 —  
	 	 500 kg
 (non-binding)


  
 The obligations of this
Section 7.9 will terminate with respect to POZEN upon the expiration of the Exclusive Manufacturing Period(s) applicable to POZEN. 
  
 7.10 Order Process. Together with each forecast provided by POZEN pursuant to Section 7.9 above, POZEN will submit a purchase order to Nycomed
for the quantities of LX Bulk Drug Substance in any binding forecasts that are not covered by a previous purchase order, specifying such quantities of LX Bulk Drug Substance and the delivery dates thereof. Except with the prior agreement of Nycomed,
POZEN will not designate in a purchase order less than ********* of LX Bulk Drug Substance for delivery on any particular delivery date. Nycomed will use commercially reasonable efforts to supply to POZEN the quantities of LX Bulk Drug Substance
ordered on the delivery dates set forth in a purchase order. 
  
 7.11 Shipping. Nycomed will package and label the LX Bulk Drug Substance for shipment in accordance with applicable law and in accordance with Nycomed’s standard practices. Nycomed will ship the LX Bulk Drug Substance on the
relevant purchase order FCA (ICC Incoterms 
  


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 2000) either Nycomed’s facility in Linz, Austria or any other place named by Nycomed and by a carrier designated by
POZEN in the applicable purchase order. Each shipment will be made according to the schedule and in the amounts specified in the applicable purchase order and under the terms and conditions set forth in this Agreement. Each batch of LX Bulk Drug
Substance will be tested and Nycomed will enclose with each shipment of LX Bulk Drug Substance a material safety data sheet and a certificate of analysis in accordance with Section 8.3 of this Agreement. Nycomed will enclose any other required
shipping documentation with each shipment of LX Bulk Drug Substance. Should Nycomed at any time during the Term have reason to believe that it will be unable to meet a delivery date of a shipment, Nycomed will promptly notify POZEN of the cause for
such delay and the steps undertaken by Nycomed to avoid or minimize such delay. 
  
 7.12 Invoices. Nycomed will send an invoice to POZEN via facsimile upon transferring a shipment of Materials under this Section 7 to the carrier designated by POZEN, and will enclose such invoice with each
shipment of Materials under this Section 7. Each such invoice will set forth a detailed account of the quantities and price of LX Bulk Drug Substance included in such shipment. All invoices submitted to POZEN by Nycomed under this Agreement
will be payable within ********* of invoice date. 
  
 8. WARRANTIES; ACCEPTANCE
AND REJECTION OF MATERIALS 
  
 8.1 Product Warranty.
Nycomed hereby warrants: (a) that at the date of delivery, any Materials, including LX Bulk Drug Substance, supplied by Nycomed under this Agreement will (i) conform to the applicable Specifications, (ii) be manufactured in compliance
with cGMP and the applicable laws of the country of manufacture, and (iii) not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, as amended (“FD&C Act”); and (b) that at
the date of delivery any LX Bulk Drug Substance supplied by Nycomed under this Agreement will (1) conform to the applicable DMF, (2) be manufactured in accordance with the Process, and (3) comply with current USP and EP monographs and
ICH guidelines (collectively, the “Product Warranty”). Failure of a delivery of Materials to comply with clause (a)(ii) of this Section 8.1 will not be deemed a breach of the Product Warranty to the extent that (A) in the
case of Nycomed Products or placebo, such materials may, in accordance with applicable law, be used for the development or testing, as 
  


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 applicable, of POZEN Products, and (B) in the case of LX Bulk Drug Substance, such LX Bulk Drug Substance may, in
accordance with applicable law, be used for the manufacture of POZEN Products for development, testing or commercial sale, as applicable. 
  
 8.2 Process Warranty. Nycomed hereby warrants that, as of the Effective Date, it has not been served with any interference action, litigation or
other notice alleging that (i) the Process infringes the intellectual property rights of any person or entity or (ii) that the Process constitutes a misappropriation of the trade secrets or other intellectual property rights of any person
or entity within the Territory. 
  
 8.3 Certificates of
Analysis. Nycomed will enclose a certificate of analysis with each shipment of Materials supplied hereunder. Such certificate of analysis will contain the results of the analysis of such Materials conducted as required in the Specifications, and
will certify with respect to each shipment and lot (identified by lot number): (i) the quantity of the shipment, and (ii) that such Materials conform to the Product Warranty. 
  
 8.4 Acceptance Testing. If a shipment of a lot of Materials or any portion thereof fails to conform to the Product
Warranty, then POZEN will have the right to either reject such nonconforming shipment of Materials or the nonconforming portion thereof, as the case may be, in accordance with the terms set forth in this Section 8.4. 
  
 8.4.1 Notice Period. 
  
 (a) Within ********* (or, in the case of the first shipment of each
type of Materials under this Agreement, *********) after delivery by Nycomed to POZEN of any shipment of any Materials that does not conform, in whole or in part, with the Product Warranty, POZEN may give written notice to Nycomed of its rejection
of either such shipment or portion thereof, as the case may be, specifying the grounds for such rejection, and deliver to Nycomed samples of the rejected Materials. If POZEN fails to give the aforesaid notice to Nycomed within the applicable period
set forth above, POZEN will be deemed to have unconditionally accepted the applicable Materials as in conformity with the Product Warranty, except as to Latent Defects. 
  


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 (b) Within ********* after POZEN’s discovery that a shipment of any Materials or portion
thereof contains a Latent Defect, POZEN may give written notice to Nycomed of its rejection of either such shipment or portion thereof, as the case may be, specifying the grounds for such rejection, and deliver to Nycomed samples of the rejected
Materials. If POZEN fails to give the aforesaid notice to Nycomed within the applicable period set forth above, POZEN will be deemed to have unconditionally accepted the applicable Materials as free of the identified Latent Defect. 
  
 8.4.2 Disputes Regarding Conformity. After receipt of a rejection
notice and samples from POZEN pursuant to the preceding subsection 8.4.1, Nycomed will be permitted, for a period of *********, to analyze the Materials rejected by POZEN for nonconformity to the Product Warranty, and to present its findings with
respect to such Materials to POZEN. If the Parties cannot agree on whether such Materials conform to the Product Warranty within ********* of Nycomed’s receipt of POZEN’s written notice of rejection and samples, then, as soon as reasonably
practicable, each Party will deliver samples of the Materials in question to an independent laboratory selected by Nycomed as soon as reasonably practicable and reasonably acceptable to POZEN, and the independent laboratory will analyze such samples
according to the methods included in the Specifications and determine whether or not such Materials conform to the Product Warranty. Nycomed will use commercially reasonable efforts to cause the independent laboratory to complete such analysis as
soon as reasonably practicable. The definitive result of such analysis by the independent laboratory will be binding on the Parties. The cost of such analysis will be borne by the Party whose assessment was incorrect. 
  
 8.4.3 Remedies. If POZEN rejects a shipment of Materials and POZEN and
Nycomed agree, or the independent laboratory determines, that such shipment of Materials does not conform to the Product Warranty, such nonconforming Materials will be held for Nycomed’s disposition, or will be returned to Nycomed (unless
prohibited by applicable laws or regulations), in each case at Nycomed’s expense, as directed by Nycomed. Nycomed will use commercially reasonable efforts to replace each nonconforming shipment of Materials, or the nonconforming portion thereof
on a batch-by-batch basis, with conforming Materials as soon as reasonably practicable or will promptly provide POZEN with a credit therefor, at POZEN’s election. 
  


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 8.4.4 Notice of Latent Defects. If Nycomed becomes aware of a Latent Defect in any shipment of
Materials or portion thereof, Nycomed will immediately notify POZEN as to the shipment involved, and, at POZEN’s election (to be communicated to Nycomed within *********), either such shipment or portion thereof, as the case may be, will be
deemed rejected as of the date of POZEN’s communication, and such nonconforming Materials will be held for Nycomed’s disposition, or will be returned to Nycomed (unless prohibited by applicable laws or regulations), in each case at
Nycomed’s expense, as directed by Nycomed. Nycomed will use commercially reasonable efforts to replace each nonconforming shipment, or the nonconforming portion thereof, with conforming Materials as soon as reasonably practicable, or will
promptly provide POZEN with a credit therefor, at POZEN’s election. 
  
 8.5 Recalls. If a Party believes it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any POZEN Product (a
“Recall”), Nycomed and POZEN will consult with each other as to how best to proceed, it being understood and agreed that the final decision as to any such Recall with respect to a POZEN Product will be made by POZEN or Sublicensees,
and the final decision as to any such Recall with respect to LX Bulk Drug Substance that has not yet been processed into a POZEN Product will be made by Nycomed. 
  
 8.6 Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other reports or information
received by POZEN indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction, illness or injury is
caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by POZEN to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any such written reports,
and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to POZEN upon conclusion of such investigation. POZEN will copy Nycomed on all correspondence with regulatory
authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products or Nycomed Products. 
  


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 9. QUALITY REGULATIONS 
  

9.1 Documentation and Record Keeping. Nycomed will keep complete, accurate and authentic accounts, notes, data and resources of all of work
performed by Nycomed related to LX Bulk Drug Substance under this Agreement, including, but not limited to, complete and adequate records pertaining to the methods and facilities used for the manufacture in accordance with master production records,
batch production records, product related documents (e.g., master formulae, validation packages, specifications, clinical trial batch related documents, batch specific deviation reports, certificates of analysis) and standard operating procedures
(“SOPs”). As soon as reasonably practicable following receipt of NDA approval for any POZEN Product, POZEN shall provide Nycomed with written notice of the date of such NDA approval, which notice shall identify by lot number the lots of LX
Bulk Drug Substance, Nycomed Products and placebo that correspond to such NDA approval, and Nycomed shall maintain such records with respect to such lots of LX Bulk Drug Substance, Nycomed Products and placebo for a minimum of *********. With
respect to each lot of LX Bulk Drug Substance supplied by Nycomed under Section 7 of this Agreement, Nycomed will maintain such records for *********. POZEN will notify Nycomed in writing of the expiration date of any POZEN Product and of any
changes thereto. An SOP will be maintained for ********* after it is superseded or deleted. 
  
 9.2 Inspections and Audits. 
  
 9.2.1 During any period in which Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed will permit designated representatives or consultants of POZEN together with designated representatives or consultants of Sublicensees to
inspect and visit ****************** the facilities at which the LX Bulk Drug Substance is manufactured, stored or tested for the purpose of determining compliance with this Agreement, as well as all pertinent regulatory requirements. Such
inspections will occur during regular business hours upon reasonable advance notice to Nycomed. In addition, if (i) Nycomed receives any Warning Letters (as defined in subsection 9.2.3 below) or (ii) POZEN has properly rejected a shipment
of Materials in accordance with the rejection procedures of Section 8.4 of this Agreement for failure to conform to the Product Warranty, then POZEN will have the right promptly thereafter to conduct an audit according to the terms specified in
this subsection 9.2.1 (which audit shall not count towards the limit of ********* as set forth above). 
  


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 9.2.2 Nycomed will inform POZEN of the results of any inspection of Nycomed’s manufacturing
facilities by a regulatory authority that could adversely affect the manufacture and supply of the LX Bulk Drug Substance by Nycomed, regardless of whether or not such inspection was conducted in connection with the LX Bulk Drug Substance
manufacture, at the conclusion of each calendar year (or earlier as expressly provided in this Agreement). If such an inspection is in connection with the LX Bulk Drug Substance manufacture, Nycomed will additionally provide POZEN with a summary of
the regulatory authority final report within ********* of Nycomed’s receipt of such report. 
  
 9.2.3 During any period in which Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed will provide POZEN within ********* of receipt with
copies of any Form No. 483 notification, Notice of Adverse Finding, or their analogous forms from any regulatory authorities (“Warning Letters”), as well as any subsequent responses by Nycomed or the regulatory authorities
relating to the manufacture of LX Bulk Drug Substance or Nycomed’s manufacturing facilities used for such manufacture. Nycomed will have the right to redact from any documentation provided to POZEN under this subsection 9.2.3 any information
that is specific to products other than the LX Bulk Drug Substance or that is related to details of the Process. 
  
 9.2.4 During any period in which Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed agrees to inform POZEN within ********* of receipt
of any notice of inquiry or inspection with respect to a facility where LX Bulk Drug Substance is manufactured by any regulatory authority from a country in which POZEN or Sublicensees plan to submit (as notified to Nycomed) or have submitted
dossiers for regulatory approval of POZEN Products containing LX Bulk Drug Substance (as notified to Nycomed) if such notice could adversely affect the manufacture or use of LX Bulk Drug Substance, and Nycomed will provide POZEN with copies of any
written communications received from regulatory authorities related to the manufacture of LX Bulk Drug Substance, and Nycomed may at its discretion redact any proprietary information relating to the Process or to products other than POZEN Products
and Nycomed Products. Nycomed will inform POZEN of the content of any proposed response to such an 
  


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 inquiry or inspection. POZEN shall provide written comments to Nycomed within ********* and Nycomed will consider
POZEN’s comments in good faith. Nycomed will provide POZEN with a copy of Nycomed’s final response within ********* of submission to the applicable regulatory authority, and Nycomed may at its discretion redact any proprietary information
relating to the Process or to products other than POZEN Products and Nycomed Products. 
  
 9.3 DMFs and Manufacturing Approvals. Nycomed and POZEN will coordinate Nycomed’s filing of DMFs in accordance with POZEN’s or the Sublicensees’ clinical development plan for the POZEN Products.
Thereafter, for so long as Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed will be responsible for filing and maintaining at its expense, and will use commercially reasonable efforts to file and maintain, in the applicable
country(ies) of the Territory all DMFs necessary for the manufacture of LX Bulk Drug Substance supplied by Nycomed under this Agreement for pre-clinical and clinical trials performed by POZEN or its Sublicensees and the commercial sale of POZEN
Products after Marketing Approvals have been obtained for such POZEN Products. POZEN will have the right to reference any DMF filed by Nycomed for LX Bulk Drug Substance in connection with the development of POZEN Products contemplated hereunder.
For so long as Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed will be responsible for filing and maintaining at its expense, and will use commercially reasonable efforts to file and maintain, the Manufacturing Approval for LX Bulk
Drug Substance supplied by Nycomed under this Agreement. During the period in which Nycomed will supply Nycomed Products and placebo to POZEN under this Agreement, Nycomed will be responsible for filing and maintaining at its expense and will use
commercially reasonable efforts to file and maintain the Manufacturing Approval for such Materials supplied by Nycomed under this Agreement. 
  
 9.4 Personnel. Neither Party will use in any capacity, in connection with any manufacturing or other services to be performed under this Agreement,
any individual who has been debarred pursuant to the FD&C Act or who is subject to an action, suit, claim, investigation or legal or administrative proceeding that could reasonably be expected to lead to a debarment of Nycomed, POZEN or any
person performing manufacturing or other services hereunder. Either Party will, if so requested by the other Party, prepare and submit a certification statement as necessary to satisfy 
  


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 the requirements of the FD&C Act. Either Party agrees to immediately inform the other Party in writing if any person
who is performing services hereunder is debarred or if such person becomes subject to an action, suit, claim, investigation or legal or administrative proceeding that could lead to a debarment of such person. 
  
 9.5 Records. Nycomed will notify POZEN that Nycomed has submitted to
regulatory authorities in the Territory as required by applicable law any annual reports or updates in connection with the maintenance of DMFs under this Agreement within ********* of the filing of such reports or updates with any regulatory
authority in the Territory. 
  
 9.6 Change Management.

  
 9.6.1 Exhibit K (attached hereto and hereby
incorporated by reference) sets forth the meanings of the terms “Major Change”, “Moderate Change”, “Minor Change” and “Change” used in this Section 9.6. 
  
 9.6.2 If Nycomed proposes to make a Major Change related to the
Materials (including the manufacture or quality control thereof), Nycomed will notify POZEN and provide information to POZEN regarding such change at a level reasonably sufficient to allow POZEN to evaluate the impact of such change on the POZEN
Products. Nycomed will not implement any such change prior to receipt of POZEN’s approval; provided, however, that such approval will not be unreasonably withheld or delayed for more than ********* following receipt of Nycomed’s above
notification, and POZEN’s failure to respond to such notification within ********* of receipt thereof shall be deemed to constitute POZEN’s approval of the proposed Major Change. Notwithstanding the aforesaid, if Nycomed proposes to make a
Major Change related to the Materials (including the manufacture or quality control thereof) and such change is required by cGMP or applicable laws or regulations, then Nycomed may implement such change without POZEN’s approval and will provide
POZEN with prompt written notice of its decision to implement such change. 
  
 9.6.3 If Nycomed proposes to make a Moderate Change related to the Materials (including the manufacture or quality control thereof), Nycomed will notify POZEN and provide information to POZEN regarding such
change at a level reasonably sufficient to allow POZEN to evaluate the impact of such change on the POZEN Products. Nycomed will 
  


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 notify POZEN as soon as such change has been implemented; provided, however, that any such implementation does not
require POZEN’s approval. 
  
 9.6.4 Any Minor Changes
related to the Materials (including the manufacture or quality control thereof) do not require any notification of POZEN or approval from POZEN prior to implementation. 
  
 9.6.5 When required or requested to do so by a regulatory authority of competent jurisdiction, POZEN may in writing
propose a Change in the Specifications or in the Process, and the Parties will discuss in good faith and use reasonable efforts to agree to a specific procedure and the costs necessary to implement such a Change and which Party will bear such costs;
provided, however, that, if reasonably requested by Nycomed and appropriate under the circumstances, POZEN will use reasonable efforts to negotiate with the applicable regulatory authority for either the waiver or modification of its requirement or
request. Prior to the agreement on the aforesaid procedure and cost, Nycomed will not be obligated to implement any such Change. 
  
 9.6.6 Additionally, POZEN may, from time to time, in writing reasonably suggest Changes in the Specifications other than the Changes provided for
in subsection 9.6.5 above, and in the case of Nycomed’s approval (which will not be unreasonably withheld), the Parties will discuss in good faith and use reasonable efforts to agree on a specific procedure and the costs necessary to implement
such other Changes to the Specifications and which Party will bear such costs. Prior to Nycomed’s approval and the agreement on the aforesaid procedure and cost, Nycomed will not be obligated to implement any such other Change. 
  
 9.6.7 If there are any additional questions regarding notification and
approval of Changes that arise during the Term, Nycomed will submit the questions to POZEN to determine the level of review/notification that may be required by the proposed Change. 
  
 9.6.8 Nycomed will establish cGMP-compliant Change control procedures which register and allow the tracking of any
and all Changes made by Nycomed related to the Materials (including the manufacture or quality control thereof). 
  


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 10. COMPENSATION 
  
 10.1 Option Fee. POZEN will pay to Nycomed a one-time, non-refundable, non-creditable option fee of US$********* within 10 days after the Effective
Date. 
  
 10.2 Option Period Milestones. POZEN will make
the following one-time, non-refundable, non-creditable payments in the amounts set forth below ********* after occurrence of the events described below: 
  

			
	 MILESTONE EVENT

	  	MILESTONE
PAYMENT


		
	 1. Earlier of: (a*********, and (b) *********
	  	US$*********
		
	 2. *********
	  	US$*********
		
	 3. Earlier of: (a) *********, or (b) *********
	  	US$*********
		
	 4. *********
	  	US$*********
		
	 5. Earlier of: (a) *********, and (b) *********
	  	US$*********

  
 10.3 Option
Exercise Fee. Within 10 days of exercise of the Option by POZEN, POZEN will pay to Nycomed a one-time, non-refundable, non-creditable exercise fee of US$500,000. 
  
 10.4 Marketing Approval Milestone Payments. POZEN will make the following non-refundable, non-creditable payments in
the amounts set forth below ********* of occurrence of the events described below: 
  

			
	 MILESTONE EVENT

	  	MILESTONE
PAYMENT


	 1. *********
	  	US$*********
	 2. *********
	  	US$*********

  
 10.5 Royalties.

  
 10.5.1 Royalties on Net Sales. 
  
 (a) Subject to the adjustments provided for in Section 10.5.4
of this Agreement, POZEN will pay to Nycomed in U.S. Dollars (with respect to Net Sales in the Exclusive Territory) or Euros (with respect to 
  


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 Net Sales in the Limited Territory) a royalty on Net Sales of POZEN Products based on the following royalty rates:
(i) *********% of Net Sales of *********; and (ii) *********% of Net Sales of *********oduct. 
  
 (b) Once the obligation to pay royalties commences, POZEN will pay royalties within ********* from the last day of each calendar quarter based on
the Net Sales of POZEN Products during such calendar quarter. 
  
 (c) No royalties will be payable on sales among POZEN INC., its Affiliates and Sublicensees, but royalties will be payable on subsequent sales by POZEN INC., its Affiliates and Sublicensees to a Third Party customer. No multiple
royalty will be payable under this Agreement because the manufacture, use or sale of a POZEN Product is covered by more than one Licensed Patent or is subject to both Know-How included in the Licensed Technology and a Licensed Patent. 
  
 10.5.2 Royalties on Sublicense Revenues.  
  
 (a) POZEN will pay to Nycomed in United States Dollars a royalty on
Sublicense Revenues in the following amounts: (i) *********% of Sublicense Revenues *********, up to a maximum royalty of US$********* based on Sublicense Revenues received from the same Sublicensee for *********; and (ii) *********% of
Sublicense Revenues *********, up to a maximum royalty of US$********* based on Sublicense Revenues received from the same Sublicensee for *********. 
  
 (b) Once the obligation to pay royalties commences, POZEN will pay royalties within********* from the last day of each calendar quarter based on
the Sublicense Revenues of POZEN Products during such calendar quarter. 
  
 10.5.3 Royalty Term. Royalties due under Sections 10.5.1 and 10.5.2 of this Agreement will be payable for each POZEN Product on a country-by-country basis until 10 years from the date of first commercial sale of such POZEN Product in
such country by POZEN or Sublicensees. 
  


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 10.5.4 Royalty Adjustments. 
  
 (a) The royalty rate set forth in Section 10.5.1 of this Agreement for each ********* will be reduced,
cumulatively: 
  
 (i) by ********* in a country of the
Exclusive Territory during such time as ********* would ********* in such country; and 
  
 (ii) by a total of ********* throughout the Exclusive Territory if POZEN or Sublicensees *********: (A) *********; or (B) *********. 
  
 (b) The royalty rate set forth in Section 10.5.1 of this Agreement for each Single Entity Product, as adjusted,
if applicable, by the preceding subsection 10.5.4(a), will be reduced by *********% in any country in the Exclusive Territory in which ********* and if and as long as such *********. For purposes of this subsection 10.5.4(b) only, a
“*********” means any *********, provided that if POZEN or a Sublicensee owns or Controls a Patent that is infringed by the manufacture, use or sale of *********, POZEN will use commercially reasonable efforts to stop such infringement or,
as applicable, to ensure that such Sublicensee will use commercially reasonable efforts to stop such infringement. 
  
 10.6 Payments and Reports. All payments made by POZEN to Nycomed pursuant to royalty or other payment obligations provided herein will be
accompanied by a written report setting forth in reasonable detail the calculation of the amount of the payment made. Such report will include, for example, a calculation of any royalties being paid and, with respect to such royalties, will include
the amount of Net Sales and Sublicense Revenues of such POZEN Products on a country-by-country basis. 
  
 10.7 Payment Method; Currency; Interest. All payments hereunder will be made in United States Dollars or Euros, as specified in this Agreement, by
wire transfer in immediately available funds to an account designated by the receiving Party. For the purpose of determining royalties payable under this Agreement, any Net Sales or Sublicense Revenues denominated in currencies other than U.S.
Dollars or Euros will be converted into U.S. Dollars or Euros, respectively, according to the conversion rate listed in the The Wall Street Journal, Eastern Edition, on the last business day of the applicable calendar quarter. Any payments or
portions thereof due hereunder that are not paid on the date such payments are due under this Agreement will bear interest at a per annum rate equal to the ********* as published in the The Wall Street Journal, Eastern Edition, on the first day of
each calendar quarter in which such payments are overdue, *********, calculated on the number of days such payment is delinquent, compounded monthly, except that such rate shall not exceed the maximum rate permitted by applicable law. 
  


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 10.8 Taxes. POZEN will have the right to withhold taxes in the event that authorities in any
country require the withholding of taxes on amounts paid hereunder to Nycomed. Such taxes will be deducted by POZEN from such payment and will be paid by POZEN to the proper taxing authority on behalf of Nycomed. POZEN will promptly secure and send
to Nycomed proof evidencing payment of such taxes withheld and paid by POZEN for the benefit of Nycomed. POZEN will assist Nycomed in claiming exemption from or reducing such deductions or withholdings under any applicable income tax treaty by
providing or filing such documentation (including certificates of residence provided by Nycomed) as may be reasonably required by Nycomed to claim such exemption or reduction. 
  
 10.9 Audit Rights; Adjustments. 
  
 10.9.1 POZEN will permit an independent certified public accountant designated by Nycomed and reasonably acceptable
to POZEN (the “Auditor”), to have access to POZEN’s records and books during regular business hours for the sole purpose of determining the accuracy of the amounts reported and actually paid or otherwise payable to Nycomed
under the terms of this Agreement (the “Audit”). Any Audit will cover a period not to exceed ********* immediately preceding such audit. Nycomed will bear all costs and expenses in connection with the Audit; provided, however,
that if any Audit reveals an understatement of Net Sales greater than *********% of the stated amount, then POZEN will bear all costs and expenses in connection with such Audit. Any such Audit will be performed upon at least ********* prior
written notice during regular business hours, and not more than ********* during the Term and during each ********* in the ********* period following expiration or termination of this Agreement. 
  
 10.9.2 Nycomed acknowledges that POZEN will require the Auditor to
execute a written confidentiality agreement containing reasonable terms and conditions with POZEN and that such Auditor will disclose to Nycomed only the amount and accuracy of payments reported and actually paid or otherwise payable under this
Agreement. The Auditor will send a copy of the report to POZEN at the same time it is sent to Nycomed. The report sent to POZEN will also include the methodology and calculations used to determine the results. 
  


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 10.9.3 If the Audit results in a determination that Net Sales or Sublicense Revenues have been
overstated, then Nycomed will credit the amount of such overpayment towards the amounts owed by POZEN under this Agreement. 
  
 10.9.4 If the Audit results in a determination that Net Sales or Sublicense Revenues have been understated, then such understated amount will be
paid to Nycomed with interest from the date originally due at the rate set forth in Section 10.7 of this Agreement for late payments, within ********* after the date on which Nycomed notifies POZEN. 
  
 11. INTELLECTUAL PROPERTY 
  
 11.1 Ownership. 
  
 11.1.1 Licensed Technology. All right, title and interest in and to
the Licensed Technology will remain exclusively owned by Nycomed, subject only to the licenses granted to POZEN hereunder. 
  
 11.1.2 Inventions. POZEN will own all right, title and interest in and to any Inventions. Except with Nycomed’s prior written consent, POZEN
will not file any applications for Patents claiming or covering one or more Inventions containing or referencing any Confidential Information of Nycomed. 
  
 11.2 Disclosure of Patents. Within 30 days of the Effective Date, Nycomed will disclose to POZEN the complete text of all pending patent
applications included in the Licensed Technology as well as copies of all correspondence concerning the prosecution thereof made or received by or on behalf of Nycomed to or from patent offices and any information or correspondence received by or on
behalf of Nycomed from patent offices concerning the institution of any interference, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving any Licensed Patents included in the Licensed Technology.
Nycomed will ship such materials DDU (ICC Incoterms 2000) to a place of destination to be named by POZEN within 10 days after the Effective Date. 
  
 11.3 Enforcement Rights. 
  
 11.3.1 Notification of Infringement. If either Party learns of any misappropriation or infringement or threatened infringement by a Third

  


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 Party of the Licensed Technology, in each case, in the Field and in the Territory, such Party will promptly notify the
other Party and will provide such other Party with all available evidence of such misappropriation or infringement. 
  
 11.3.2 Enforcement of Patents and Product Rights in the Territory. 
  
 (a) ********* will have the first right, but not the obligation, to institute, prosecute and control at its own
expense any action or proceeding with respect to misappropriation or infringement in the Field and in the Territory of the Licensed Technology, by counsel of its own choice, and will consult with ********* on any actions that ********* proposes to
take in such action or proceeding. If ********* fails to bring an action or proceeding or otherwise take appropriate action in ********* discretion to abate such infringement in the Field and in the Territory within a period of ********* of written
notice by ********* to ********* requesting such action, ********* will have the right, but not the obligation, to bring and control, by counsel of its own choice, any such action or proceeding. 
  
 (b) If a Party brings any action or proceeding under this subsection
11.3.2, the other Party agrees, at the request and expense of the first Party, to be joined as a Party plaintiff to the extent necessary to prosecute the action or proceeding. Each Party will reasonably cooperate with the other Party in any such
action or proceeding brought by a Party against a Third Party. Each Party will have the right to consult with the other Party and to participate in and be represented by independent counsel in any such action or proceeding at its own expense.

  
 11.3.3 Settlement with a Third Party. The Party that
controls the prosecution of a given action under subsection 11.3.2 will also have the right to control settlement of such action; provided, however, that no settlement will be entered into with respect to the Licensed Technology without the
written consent of Nycomed, such consent not to be unreasonably withheld. 
  
 11.3.4 Awards. Any damage award resulting from any action or proceeding pursuant to subsection 11.3.2 will be retained by the Party to which such damage award is granted. 
  


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 11.4 Covenant. ********* hereby covenants and agrees not to enforce against ********* or any
direct or indirect licensee, sublicensee or contractor of ********* any Patent claiming or covering ********* that would be infringed by the development, use, manufacture or sale of ********* or, after expiration or termination of this Agreement,
*********. 
  
 11.5 Maintenance. Nycomed will use
commercially reasonable efforts to maintain and prosecute the Licensed Patents included in the Licensed Technology in a reasonable scope; provided, however, that such obligation of Nycomed shall cease after ********* with respect to such
Licensed Patents included in the Licensed Technology which at that date even in absence of the licenses granted hereunder would not be infringed by the manufacture, use or sale of POZEN Products by POZEN, except in case POZEN agrees to ********* of
such Licensed Patents included in the Licensed Technology. Nycomed agrees to provide POZEN with (a) written notice of any issuance of a Patent from a patent application included in the Licensed Patents as soon as reasonably practicable and
(b) written notice of Nycomed’s decision to cease prosecution and maintenance of a patent application included in the Licensed Patents as soon as reasonably practicable. 
  
 12. REPRESENTATIONS AND WARRANTIES 
  
 12.1 Mutual Representations and Warranties. Each of the Parties hereby represents and warrants to the other Party as follows: 
  
 12.1.1 such Party is a corporation duly organized, validly existing
and in good standing under the laws of the state in which it is incorporated; 
  
 12.1.2 this Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms, subject to applicable bankruptcy, reorganization, insolvency, moratorium and other
laws affecting creditors’ rights generally from time to time in effect and to general principles of equity and the execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or
understanding, oral or written, to which it is a Party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. Each Party expressly represents and
warrants that it has the full power and authority to enter into this Agreement and to carry out the obligations contemplated hereby; and 
  


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 12.1.3 it has taken all necessary corporate action on its part to authorize the execution and
delivery of this Agreement. 
  
 12.2 Representations and
Warranties of Nycomed. Nycomed represents and warrants to POZEN that: 
  
 12.2.1 Nycomed will not, during the Term, grant any right to any Third Party relating to the Licensed Technology in the Field in the Territory which would conflict with the rights granted to POZEN hereunder;

  
 12.2.2 To the best of Nycomed’s knowledge as of
the Effective Date, there is no Third Party infringing any of the Licensed Patents included in the Licensed Technology in the Territory or misappropriating or using any of the Know-How included in the Licensed Technology in the Territory contrary to
the rights granted to POZEN pursuant to this Agreement; 
  
 12.2.3 Nycomed has obtained the assignment of all interests and all rights of any and all Third Parties (including, but not limited to employees) with respect to any Licensed Patents included in the Licensed Technology; 

 
 12.2.4 As of the Effective Date, Nycomed has not been served with
any interference action or litigation with respect to any Licensed Patents included in the Licensed Technology, and Nycomed has not received any written communication which expressly threatens interference actions or other litigation before any
patent office, court, or any other governmental entity in any jurisdiction in regard to any such Patents; 
  
 12.2.5 Exhibit A (excluding any products listed thereon as exceptions) contains a complete list of all pharmaceutical products developed by Nycomed
and for which Nycomed filed for Marketing Approval prior to the Effective Date, or which Nycomed commercialized prior to the Effective Date, that contain or comprise Lornoxicam (or any salts, solvates or polymorphs thereof) as the single active drug
substance; 
  
 12.2.6 To the best of Nycomed’s
knowledge as of the Effective Date, Nycomed Controls all Patents in the Territory claiming the products listed on Exhibit A, excluding the products listed thereon as exceptions (with respect to which Nycomed does not Control all related
Patents); 
  


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 12.2.7 Exhibit G contains a complete list of the Patents Controlled by Nycomed as of the Effective
Date that would be infringed by the use or sale of Nycomed Products by an unlicensed Third Party, but excluding any Patents relating solely to the manufacture of LX Bulk Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof);

  
 12.2.8 Exhibit H contains a complete list of the
materials described in Section 11.2 of this Agreement; and 
  
 12.2.9 As of the Effective Date, Nycomed has not undertaken, and has no plans to undertake, efforts to develop, market, or commercialize any pharmaceutical product containing an isomer of Lornoxicam as an active substance.

  
 12.3 Limitation of Warranty. EXCEPT AS EXPRESSLY STATED
IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, WITH RESPECT TO ANY
MATERIALS, INFORMATION, SERVICES, OR LICENSES PROVIDED TO THE OTHER PARTY PURSUANT TO THIS AGREEMENT. 
  
 13. INDEMNIFICATION 
  
 13.1 Indemnification by POZEN. POZEN will indemnify, defend and hold Nycomed and its directors, officers and employees (each a “Nycomed Indemnitee”) harmless from and against any damages, costs or expenses, including
reasonable attorneys’ fees and expenses (collectively, “Losses”) incurred by a Nycomed Indemnitee in connection with any claim, lawsuit or other action by a Third Party (“Third Party Claim”) to the extent such
Losses arise out of, relate to or result from: (a) the development, testing, manufacture, use, sale, offer to sell, sale, importation or distribution (including distribution free of charge) of POZEN Products or use of Materials or use of any
information, data or documentation provided by Nycomed in connection with this Agreement by or on behalf of POZEN or Sublicensees (other than Nycomed) after the Effective Date; (b) the breach by POZEN of any of its representations, 

 


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 warranties, covenants or obligations contained within this Agreement; or (c) the gross negligence or willful
misconduct of POZEN, its directors, officers or employees in connection with this Agreement. Notwithstanding the foregoing, POZEN will have no obligation under this Section 13.1 with respect to any Losses for which a POZEN Indemnitee is
entitled to indemnification pursuant to Section 13.2 of this Agreement. 
  
 13.2 Indemnification by Nycomed. Nycomed will indemnify, defend and hold POZEN and its directors, officers and employees, (each a “POZEN Indemnitee”) harmless from and against any Losses
incurred by a POZEN Indemnitee in connection with any Third Party Claim to the extent such Losses arise out of, relate to or result from: (a) the breach by Nycomed of any of its representations, warranties, covenants or obligations contained
within this Agreement, including the supply by Nycomed of Materials that do not conform to the Product Warranty (except to the extent POZEN did not perform reasonable physical inspection or standard testing of such Materials in accordance with
standards in the pharmaceutical industry, including in any event testing for purity and assay according to the methods included in the applicable Specifications); or (b) the gross negligence or willful misconduct of Nycomed, its directors,
officers or employees in connection with this Agreement. Notwithstanding the foregoing, Nycomed will have no obligation under this Section 13.2 with respect to any Losses for which a Nycomed Indemnitee is entitled to indemnification pursuant to
Section 13.1 of this Agreement. 
  
 13.3 Indemnification
Procedures. A Party which or whose officers, directors or employees intend to claim indemnification under Section 13.1 or 13.2 of this Agreement (the “Indemnitee”) will promptly notify the other Party (the
“Indemnitor”) in writing of any claim, lawsuit or other action in respect of which the Indemnitee or any of its directors, officers or employees intend to claim such indemnification as soon as reasonably practicable after the
assertion of such claim; provided, however, that the failure to provide written notice of such claim as soon as reasonably practicable will not relieve the Indemnitor of any of its obligations hereunder, except to the extent that the
Indemnitor is prejudiced by such failure to provide prompt notice. For purposes of clarification, an officer, director or employee of a Party will not have the right to claim indemnification directly from the other Party under this Section 13
and shall instead make any such claim solely through the Party employing such officer, director or employee; provided, however, that the foregoing shall 
  


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 not be construed to limit any right to indemnification that any officer, director or employee of a Party may have other
than under this Agreement (e.g., under applicable laws or regulations). The Indemnitor will have the right to assume the complete control of the defense, compromise or settlement of any such claim with the prior written consent of such Indemnitee,
which such consent will not be unreasonably withheld or restricted or withdrawn or restricted at a later stage; provided, however, that Indemnitee will have the right to withhold consent to any compromise or settlement in its sole discretion
if such compromise or settlement includes any admission of wrongdoing on the part of an Indemnitee, or limits the scope of any claims in or enforceability of any Patents owned by or licensed to the Indemnitee. Subject to the aforesaid, the
Indemnitor may at its own expense, employ legal counsel to defend the claim at issue and at any time after Indemnitor has assumed defense of a claim, the Indemnitor may exercise, on behalf of the Indemnitee, any rights which may mitigate the extent
or amount of such claim; provided, however, the Indemnitee: (a) may, in its sole discretion and at its own expense, employ legal counsel to represent it (in addition to the legal counsel employed by the Indemnitor) in any such matter,
and in such event legal counsels selected by the Indemnitee and the Indemnitor will be required to confer and cooperate with each other in such defense, compromise or settlement for the purpose of informing and sharing information; (b) will, at
its own expense, make available to Indemnitor those employees, officers and directors of Indemnitee whose assistance, testimony or presence is necessary, useful or appropriate to assist the Indemnitor in evaluating and in defending any such claim;
provided, however, that any such access will be conducted in such a manner as not to interfere unreasonably with the operations of the businesses of Indemnitee; and (c) will otherwise reasonably cooperate with the Indemnitor and its
legal counsel in the investigation and defense of such claim. 
  
 13.4 Insurance. During the Term *********, each Party will maintain commercially reasonable insurance coverage commensurate with its obligations under this Agreement. 
  
 14. LIABILITY 
  
 14.1 Limitation. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT
OF OR 
  


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 RELATING IN ANY WAY TO THIS AGREEMENT (EXCEPT WITH RESPECT TO THE PROVISIONS SET FORTH IN SECTIONS 13 AND 15 OF THIS
AGREEMENT), INCLUDING, BUT NOT LIMITED TO, ANY CLAIM FOR DAMAGES BASED UPON LOST PROFITS. 
  
 14.2 Affiliates. Each of POZEN INC. and Nycomed Danmark ApS will be responsible and liable to each other for any of its Affiliates’, contractors’ or consultants’ acts, performances, omissions or
failures to perform in connection with this Agreement, as if such acts, performances, omissions or failures were made by themselves. 
  
 15. CONFIDENTIALITY, PUBLICATIONS, PUBLICITY 
  
 15.1 Confidential Information. Any information or materials communicated by one Party to the other Party, or as to which one Party provides the
other Party with access, in connection with this Agreement will be deemed “Confidential Information” of the disclosing Party if either (a) marked “confidential” or with a similar legend, or (b) if disclosed orally or
visually, if identified as being confidential at the time of such oral or visual disclosure, and thereafter reduced to writing, marked “confidential” or with a similar legend, and sent to the other Party within ********* of such oral or
visual disclosure, or (c) if the nature of such information or materials or circumstances of disclosure would suggest to a reasonable person that such disclosure was confidential, which will in any event apply to the Nycomed Product
Deliverables, the IND Deliverables and any information or materials that POZEN accesses at Nycomed’s facilities. Notwithstanding the preceding sentence, “Confidential Information” will not be deemed to include information or materials
that the receiving Party can demonstrate, by competent written proof: 
  
 15.1.1 At the time of disclosure is published or is publicly known or otherwise in the public domain, other than through any act or omission by the receiving Party; 
  
 15.1.2 Was already known to the receiving Party, other than under an obligation of confidentiality or non-use, prior
to the time of disclosure by the disclosing Party; 
  
 15.1.3
Is disclosed to the receiving Party in good faith, without an obligation of confidentiality, by a Third Party not under any obligation of confidence with respect to such information, after the time of disclosure by the disclosing Party; or

  


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 15.1.4 Is independently developed by employees of the receiving Party who had no access to the
disclosing Party’s Confidential Information. 
  
 15.2
Treatment of Confidential Information. The Parties agree that during the Term and for ********* after the expiration or termination of this Agreement for any reason whatsoever, a Party receiving Confidential Information of the other Party will:
(a) treat any such Confidential Information disclosed to it by the other Party as strictly confidential; (b) not disclose such Confidential Information to Third Parties without the prior written consent of the other Party, other than to
the extent necessary in the performance of this Agreement to Sublicensees, its contractors or any consultants, provided that such disclosure be under confidentiality agreements with provisions substantially similar to those contained in this
Agreement and further provided that the Party so disclosing Confidential Information shall be fully responsible and liable for any breach of any such confidentiality agreement by any Sublicensee, contractor or consultant; (c) not use such
Confidential Information for purposes other than those authorized expressly herein; and (d) use reasonable efforts to prevent unauthorized access to such Confidential Information. 
  
 15.3 Access. Access to Confidential Information will be limited to those employees of the Party receiving
Confidential Information who reasonably require such Confidential Information in order to carry out activities authorized pursuant to this Agreement, provided that such access be under confidentiality agreements with provisions substantially similar
to those contained in this Agreement and further provided that such Party shall be fully responsible and liable for any breach of any such confidentiality agreement by any such employee. 
  
 15.4 Permitted Disclosures. Notwithstanding any other provision in this Agreement, a receiving Party may disclose
Confidential Information of the disclosing Party to the extent such disclosure is required by law or court order, provided that the receiving Party gives the disclosing Party prompt written notice of the requirement to disclose and reasonably
cooperates with the disclosing Party to seek a protective order or other restrictions on the disclosure of such Confidential Information of the disclosing Party. Any such required disclosure will be limited only to that 
  


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 Confidential Information that is required to be disclosed and such disclosed Confidential Information will remain
Confidential Information hereunder despite the required disclosure. 
  
 15.5 Return of Confidential Information. Upon termination or expiration of this Agreement for any reason whatsoever, each Party hereto will return or destroy (and certify the destruction of), as instructed by the disclosing Party,
all Confidential Information of the other Party in its, its contractors’ or consultants’ or the Sublicensees’ possession to the other Party; provided, however, that each Party may retain: (a) a single archival copy of the
Confidential Information of the other Party solely for the purpose of determining the extent of disclosure of Confidential Information hereunder and assuring compliance with the surviving provisions of this Agreement (b) subject to the non-use
and non-disclosure provisions of this Section 15, any portion of the Confidential Information of the other Party which is contained in laboratory notebooks; and (c) subject to the non-use and non-disclosure provisions of this
Section 15, any portion of the Confidential Information of the other Party which a Party is required by mandatory applicable law to retain. 
  
 15.6 Confidentiality of the Agreement Terms. During the 3-month period following the Effective Date, neither Party will disclose or announce to any
Third Party the fact that this Agreement has been executed unless such disclosure or announcement is mutually agreed to by the Parties, except that either Party may disclose the execution of this Agreement to its accountants, attorneys and insurers
who are bound by law or contract to maintain the confidentiality of such information. The first press release announcing the execution of this Agreement will be subject to mutual agreement of the Parties in advance and, unless otherwise mutually
agreed by the Parties, will occur promptly after the end of the 3-month period following the Effective Date. The foregoing provisions of this Section 15.6 shall be deemed material obligations of the Parties. For purposes of clarification, the
preceding sentence shall not be construed to mean or suggest that any other particular obligation of either Party hereunder is or is not material. Neither Party will disclose the terms of this Agreement to any Third Party without the prior written
consent of the other Party; provided, however, that either Party may disclose the terms of this Agreement to actual or prospective investors and corporate partners (including Sublicensees), to a Party’s accountants, attorneys, insurers
and other professional advisors, and as required by applicable laws and regulations of the U.S. Securities and Exchange Commission and any stock exchange on which a Party’s stock is traded. 
  


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 16. TERM AND TERMINATION 
  

16.1 Term of the Agreement. The term of this Agreement (the “Term”) will commence on the Effective Date and end upon the first
to occur of: (a) the date of expiration of all royalty obligations in all countries in the Territory as provided in Section 10 of this Agreement, and (b) termination of this Agreement as provided in this Section 16. 

 
 16.2 Termination for Material Breach. In the event of a material
breach of this Agreement by either Party, the non-breaching Party will have the right to terminate this Agreement by written notification to the other Party, effective immediately upon receipt, if such breach is not cured within ********* after
receipt of written notice of such breach from the non-breaching Party. 
  
 16.3 Expiration of Option Period. This Agreement will terminate upon expiration of the Option Period if POZEN has not exercised the Option pursuant to Section 3.1 of this Agreement during the Option Period. 
  
 16.4 Termination at Will. In the event that, despite exercising its
commercially reasonable efforts to develop and Commercialize POZEN Products in accordance with Section 6.3, POZEN determines in good faith that it is not commercially or scientifically feasible to continue development and Commercialization
efforts with respect to POZEN Products, POZEN may provide Nycomed with written notice of such determination, in which event the Parties shall within ********* commence good faith negotiations regarding how to proceed and shall continue such good
faith negotiations for up to *********. If the Parties are unable to reach agreement prior to the end of such ********* negotiation period, POZEN shall have the right to terminate this Agreement by providing written notice of termination to Nycomed
within ********* after the end of such ********* period, effective immediately upon receipt. 
  
 16.5 Force Majeure. The Party not subject to force majeure will have the right to terminate this Agreement pursuant to Section 19.8 of this Agreement, effective immediately upon receipt of written notice
of termination. 
  


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 16.6 Severability. This Agreement may be terminated in accordance with Section 19.6 of this
Agreement. 
  
 16.7 No Challenge. Nycomed has the right to
terminate this Agreement at any time in the event POZEN or a Sublicensee initiates a lawsuit or other proceeding challenging the validity or enforceability of any Licensed Patent included in the Licensed Technology. Such termination shall be
(a) effective *********to POZEN in the case of a lawsuit or proceeding initiated by POZEN, and (b) effective ********* to POZEN in the case of a lawsuit or proceeding initiated by a Sublicensee, unless POZEN has caused such Sublicensee to
cease such activity within such ********* period. 
  
 16.8
Insolvency. If either POZEN INC. or Nycomed Danmark ApS commences as a debtor any proceedings under any bankruptcy, insolvency, reorganization, dissolution or liquidation law or if any such proceedings are commenced against either POZEN INC. or
Nycomed Danmark ApS, the other Party will have the right to terminate this Agreement, effective immediately upon receipt of written notice of termination. 
  
 17. CONSEQUENCES OF EXPIRATION AND TERMINATION 
  
 17.1 Expiration. If this Agreement expires pursuant to Section 16.1(a) above, the licenses granted by Nycomed in Section 4.1 of this
Agreement will survive as non-exclusive and become perpetual, fully-paid and royalty-free. 
  
 17.2 Termination. If this Agreement terminates for whatsoever reason, POZEN will promptly: (a) refrain from using the Licensed Technology or any portion thereof and exercising any of its licenses granted
under this Agreement, and (b) terminate or cause the termination of all Sublicense Agreements with respect to the Licensed Technology or any portion thereof that is sublicensed to the Sublicensees, and (c) at Nycomed’s request, return
to Nycomed all unused Materials (except to the extent that retention of such Materials is required by applicable laws or regulations, and except LX Bulk Drug Substance supplied by Nycomed pursuant to Section 7 of this Agreement) and destroy all
Materials which have been modified with POZEN’s proprietary methods (except to the extent that retention of such Materials is required by applicable laws or 
  


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 regulations and except LX Bulk Drug Substance supplied by Nycomed pursuant to Section 7 of this Agreement), and
(d) permit Nycomed to cancel with any regulatory authority (including the FDA) any POZEN right of reference to Nycomed’s INDs, DMFs or MAAs. Notwithstanding the aforesaid, if this Agreement terminates pursuant to Section 16.2 for
breach by POZEN, Section 16.3 or Section 16.4, POZEN will promptly withdraw all filed and granted INDs and all filed and granted Regulatory Approvals pertaining to POZEN Products. Notwithstanding the aforesaid, if this Agreement terminates
pursuant to Section 16.4 before the end of the Option Period, POZEN will promptly pay to Nycomed an appropriate percentage (to be agreed upon in good faith by the Parties) of any unpaid milestone payment under Section 10.2 for which
Nycomed has performed all or part of the applicable activities under Section 2.3 (as reasonably evidenced by Nycomed and set forth in writing), based on the efforts expended by Nycomed up to the date of termination (not to exceed the applicable
milestone payment). 
  
 17.3 Accrued Claims. No expiration
or termination of this Agreement will relieve any Party hereto from any liability which, at the time of such expiration or termination, has already accrued to such Party prior to such expiration or termination or which is attributable to a period
prior to such expiration or termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to such expiration or termination.

  
 17.4 Survival. In the event of expiration or
termination of this Agreement, the following provisions will survive, together with the definitions of the defined terms used therein and any related provisions of the exhibits referenced therein: Sections 2.1 (only in respect to POZEN’s
obligation to provide the results set forth in Section 2.1 and Nycomed’s right to use such results), 4.2.8, 4.2.9, 7.5 (only in respect to POZEN’s obligation not to use the Patents, or use or disclose Confidential Information, of
Nycomed as set forth in Section 7.5.1), 8.1, 8.4, 8.5, 8.6, 9.1, 10.2 (only if this Agreement is terminated pursuant to Section 16.4), 10.6, 10.7, 10.8, 10.9, 11.1, 11.4, 12.3, 13, 14, 15, 17, 18 and 19. All other provisions, including all
rights and obligations thereunder, will terminate and be of no further force and effect (except to the extent necessary with respect to liabilities accrued prior to expiration or termination as described in Section 17.3 above). 
  


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 18. DISPUTE RESOLUTION 
  

18.1 The Parties will try to settle their differences amicably between themselves. In the event of any controversy or claim arising out of or
relating to any provision of this Agreement or the performance or alleged non-performance of a Party of its obligations under this Agreement (“Dispute”), a Party may notify the other Party in writing of such Dispute. If the Parties
are unable to resolve the Dispute within ********* of receipt of the written notice by the other Party, such dispute will be resolved according to the procedures set forth elsewhere in this Agreement, or, absent such procedures, referred to the
Chief Executive Officers of each of the Parties (or their respective designees) who will use their good faith efforts to resolve the Dispute within ********* after such referral. Notwithstanding the aforesaid, a Party will not be obligated to comply
with the procedures as provided in this Section 18.1 and may immediately invoke the procedures set forth in Section 18.2 if such compliance might result in such Party’s claims becoming statute barred. 
  
 18.2 Any Dispute that is not resolved as provided in the preceding
Section 18.1 will be finally settled under the Rules of Conciliation and Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with such Rules. The language of any such arbitration proceeding
will be English, and any such arbitration proceeding will take place in London, England. Nothing herein shall limit or restrict a Party’s ability to seek injunctive or other equitable relief in the event of a breach or anticipated breach of
Section 15. Notwithstanding the foregoing, either Party shall have the right to pursue an action in a court of competent jurisdiction to obtain injunctive or other equitable remedy, in order to preserve the status quo during the resolution of
any Dispute under this provision. 
  
 19. MISCELLANEOUS 
  
 19.1 Further Assurances. At any time during the Term, each Party
will, at the request of the other Party, use reasonable efforts to: (a) deliver to the other Party such records, data or other documents consistent with the provisions of this Agreement, (b) execute and deliver, or cause to be delivered,
all such assignments, consents, documents or further instruments of transfer or license consistent with the terms of this Agreement, and (c) take or cause to be taken all such other actions, as a Party may reasonably deem necessary in order for
such Party to obtain the full benefits of this Agreement and the transactions contemplated hereby. 
  


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 19.2 Assignment. Neither POZEN INC. nor Nycomed Danmark ApS will assign its rights or obligations
under this Agreement to any Third Party, without the prior written consent of the other, except that either POZEN INC. or Nycomed Danmark ApS may assign such rights and obligations to a Third Party in connection with a merger, consolidation,
transfer or sale of all or substantially all of the assets (including those to which this Agreement relates) of the assignor. In addition, either POZEN INC. or Nycomed Danmark ApS may assign its rights and obligations under this Agreement to an
Affiliate without the prior written consent of the other; provided, however, that in the case of assignment to an Affiliate, the assignor will be responsible and liable for the compliance of such Affiliate with this Agreement. All permitted
assignments by either POZEN INC. or Nycomed Danmark ApS of any of its rights under this Agreement will be subject to all of the terms and conditions of this Agreement. All successors, permitted assignees of either POZEN INC. or Nycomed Danmark ApS
will be subject to, and will be bound by, all the terms and conditions of this Agreement. Any purported assignment not permitted under the terms of this Agreement will be null, void, and of no effect. 
  
 19.3 Independent Contractors. The Parties hereto are independent
contractors. Nothing contained herein will constitute either Party the agent of the other Party for any purpose whatsoever, or constitute the Parties as partners or joint venturers. Employees of each Party remain employees of said Party and will be
considered at no time agents of or owing a fiduciary duty to the other Party. Neither Party hereto will have any implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party
to any other contract, agreement or undertaking with any Third Party. 
  
 19.4 Waiver. The failure of either Party to enforce any provision of this Agreement at any time will not be construed as a present or future waiver of such or any other provision of this Agreement. The express waiver by either Party
of any provision or requirement hereunder will not operate as a future waiver of such or any other provision or requirement and will be effective only if set forth in a written instrument signed by a duly authorized representative of the Party
waiving such provision or requirement. 
  


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 58. 








 19.5 Amendment. The Parties hereto may amend, modify or alter any of the provisions of this
Agreement, but such amendment, modification or alteration will be valid and binding on either Party only if made by a written instrument that explicitly refers to this Agreement and that is signed by a duly authorized representative of each Party.

  
 19.6 Severability. In the event that any provision in
this Agreement is held to be unlawful or invalid in any jurisdiction, the meaning of such provision will be construed to the greatest extent possible so as to render it enforceable. If no such construction can render such provision enforceable, it
will be severed. The remainder of this Agreement will remain in full force and effect, and the Parties will negotiate in good faith a reasonable substitute provision that is valid and enforceable in such jurisdiction. If the Parties are unable to
agree on a substitute provision, and if a Party reasonably and in good faith determines that the unlawful or invalid provision was an essential element of this Agreement without which such Party would not have entered into this Agreement, as
evidenced by this Agreement as a whole, then such Party may terminate this Agreement by written notice to the other Party effective upon receipt. 
  
 19.7 Notice. All notices hereunder must be given in writing and will be deemed given if delivered personally or by facsimile transmission (receipt
confirmed), mailed by registered or certified mail (return receipt requested) with postage prepaid, or sent by express courier service (FedEx or other reputable, internationally recognized courier service), to the Parties at the following addresses
(or at such other address for a Party as will be specified by like notice; provided that notices of a change of address will be effective only upon receipt thereof). 
  
 If to POZEN: 
  
 POZEN, Inc. 
 1414 Raleigh Road 
 Suite 400 
 Chapel Hill, NC 27517 

Attention: President 
 Facsimile: +1
(919) 913 1039 
  


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 59. 








 If to Nycomed: 
  

Nycomed Danmark ApS 
 Langebjerg 1

 DK-4000 Roskilde 
 Denmark

 Attention: Senior Vice President International Sales 
 Facsimile: +45 46 75 69 04 
  
 19.8 Force Majeure. Neither Party will be deemed to be in breach of this Agreement as a result of default, delay or failure to perform by such Party which is due to any cause beyond the reasonable control of such Party, including
without limitation fire, earthquake, acts of God, severe weather, acts of war, strikes, lockouts or other labor disputes, riots, civil disturbances, actions or inactions of governmental authorities (except actions in response to a breach of
applicable laws by such Party), or epidemics. In the event of any such force majeure, the Party affected will promptly notify the other Party, will use commercially reasonable efforts to overcome such force majeure, and will keep the other Party
informed with respect thereto. If such force majeure continues for a period of more than 180 days and concerns a material obligation of a Party, the Party not subject to such force majeure may terminate this Agreement by written notice to the other
Party, effective immediately upon receipt. 
  
 19.9
Counterparts. This Agreement may be executed by the Parties in one or more identical counterparts, all of which together will constitute this Agreement. If this Agreement is executed in counterparts, no signatory hereto will be bound until both
Parties have duly executed a counterpart of this Agreement. 
  
 19.10 Governing Law. This Agreement will be governed by, and construed and interpreted in accordance with, the laws of Denmark, with the exclusion of the United Nations Convention on Contracts for the International Sale of Goods,
without giving effect to any choice of law rule that would cause the application of the laws of any jurisdiction other than the internal laws of Denmark to the right and duties of the Parties. 
  
 19.11 Construction. Unless used in combination with the word
“either,” the word “or” is used throughout this Agreement in the inclusive sense (and/or). The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent
of this Agreement or the intent of any provision contained in this 
  


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 60. 








 Agreement. The term “including” as used herein will mean including, without limiting the generality of any
description preceding such term. This Agreement has been drafted and negotiated jointly by the Parties and will not be construed against a Party by virtue of such Party having drafted this Agreement or a particular provision hereof. Unless expressly
provided herein to the contrary, all time limits, notice periods, deadlines or the like described herein will be governed by the following parameters: (i) all time periods that are 5 days in length or less will be deemed to be business days,
and (ii) all time periods greater than 5 days in length will be deemed to be calendar days. 
  
 19.12 English Language. This Agreement has been written and executed in the English language. Any translation into any other language will not be
an official version of this Agreement, and in the event of any conflict in interpretation between the English version and such translation, the English version will control. 
  
 19.13 Entire Agreement. This Agreement, including any Exhibits attached hereto, constitutes the entire agreement of
the Parties with respect to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings and negotiations, whether oral or written, with respect to such subject matter. 
  
 19.14 Purchase Orders. Notwithstanding anything to the contrary in
this Agreement, in the event of any conflict between the terms set forth in any purchase order submitted by POZEN hereunder and this Agreement, the terms of this Agreement shall prevail, and no purchase order that conflicts with the terms of this
Agreement will be binding on Nycomed. 
  
 19.15 V.A.T. All
amounts to be paid by POZEN to Nycomed under this Agreement will be paid plus V.A.T. (if applicable). 
  
 [Remainder of page intentionally left blank. Signature page follows.] 
  


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 61. 








 IN WITNESS WHEREOF, the Parties have
caused this Agreement to be executed as of the Effective Date by signature of their duly authorized representatives. 
  

			
	POZEN Inc.
		
	By:	 	 /s/ John Plachetka


	Name:	 	 John Plachetka


	Title:	 	 Chairman, President and CEO


	
	NYCOMED DANMARK APS
		
	By:	 	 /s/ Knud Lynge


	Name:	 	 Knud Lynge


	Title:	 	 Senior Vice President


		
	By:	 	 /s/ Charles Depasse


	Name:	 	 Charles Depasse


	Title:	 	 Senior Vice President


		
	By:	 	 /s/ Runar Bjørklund


	Name:	 	 Runar Bjørklund


	Title:	 	 CFO


		
	By:	 	 /s/ Thor-Björn Conradson


	Name:	 	 Thor-Björn Conradson


	Title:	 	 Senior Vice President




  
 SIGNATURE PAGE TO 
 DEVELOPMENT, OPTION
AND LICENSE AGREEMENT 
  

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 Exhibit A 
  

EXISTING NYCOMED PRODUCTS 
  

			
	 FORMULATION:

	  	 DOSAGE STRENGTH:


	 Tablets
	  	 4 mg

		
	 Tablets
	  	 8 mg

		
	 Quick release tablets
	  	 8 mg

		
	 Vials
	  	 8 mg

		
	 EXCEPT:
	  	 
		
	 Tablets
	  	 2 mg/4 mg developed by Taisho, Japan

		
	 Scored Tablets
	  	 8 mg developed by Formenti, Italy

		
	 Suppositories
	  	 12 mg developed by Merckle, Germany


  

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 EXHIBIT B 
  
 DESCRIPTION OF EXISTING NYCOMED PRODUCT DELIVERABLES 
  

	1)	(a) The following quantities of cGMP- and Specification-compliant blinded supplies of the oral formulations of the following Existing Nycomed Products and matching placebos,
provided in bulk: *********; 

  
 (b) *********,
provided in bulk, of blinded supplies of the injectable formulation of the Existing Nycomed Products and placebos, in the same form used by Nycomed in its clinical trials; 
  
 (c) *********, provided in bulk, of cGMP- and Specification-compliant quantities of LX Bulk Drug Substance; and 

 
 (d) full copies of the batch records for the Materials described in 1(a)
and 1(b), and one or more diagrams identifying the solvents and reagents used for the manufacture of the Materials described in 1(c). 
  

	2)	All of the following, to the extent in existence as of the Effective Date and subject to Section 2.3 of the Agreement: 

  
 (a) Nycomed’s current analytical methods, associated validation
packages and reference standards relating to LX Bulk Drug Substance and to any Existing Nycomed Product; 
  
 (b) Nycomed’s stability data for LX Bulk Drug Substance and for any Existing Nycomed Product; 
  
 (c) access at Nycomed’s facilities to all of the clinical data and
study reports relating to LX Bulk Drug Substance and Existing Nycomed Product specified in Schedule B – 1 attached hereto and hereby incorporated by reference; 
  
 (d) access at Nycomed’s facilities to all of the preclinical data relating to LX Bulk Drug Substance and Existing
Nycomed Product specified in Schedule B – 2 attached hereto and hereby incorporated by reference; 
  


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 (e) full copies of all Phase I *********reports and the following Phase II/III reports: ********* as well
as copies of the final reports of the preclinical studies specified in part II of Schedule B-2; and 
  
 (f) a copy of the *********safety report for LX Bulk Drug Substance and any Existing Nycomed Product. 
  
 Delivery schedule: 
  
 Nycomed will use commercially reasonable efforts to deliver to POZEN the materials listed in
clause 1 of this Exhibit B within ********* after the Effective Date. Nycomed will deliver to POZEN the materials listed in clause 2 (other than 2(c) and (d)) of this Exhibit B within ********* after the Effective Date. Nycomed will grant access to
the materials listed in 2(c) and (d) as soon as reasonably practicable (but no later than ********* from the Effective Date), whereupon such materials will be deemed to have been delivered. Nycomed agrees that, in accessing the materials listed
in 2(c) and (d) at Nycomed’s facilities, POZEN will have the right to bring its own electronic scanning equipment to Nycomed’s facilities and to scan electronic copies of such materials using such equipment for POZEN’s use in
accordance with this Agreement. 
  
 Upon request by POZEN, Nycomed will use
commercially reasonable efforts to deliver to POZEN up to ********* additional shipments of the Materials described in 1(a) and 1(c), as well as tablets of 4 mg and 8 mg and matching placebo, for use in the Initial Development Program. Each such
shipment will not exceed (i) ********* (of all oral formulations and strengths) of Existing Nycomed Products and matching placebos and (ii) such quantities of LX Bulk Drug Substance as POZEN requests and with respect to which POZEN
demonstrates, in good faith discussions with Nycomed, a reasonable proposed use relating to the Initial Development Program. Upon receiving POZEN’s request for such Materials, Nycomed will provide POZEN with a delivery date for such Materials.
Nycomed will use commercially reasonable efforts to deliver such Materials on or before the specified delivery date. 
  
 Nycomed will ship all materials set forth in 1) and 2) (other than 2(c) and 2(d)) of this Exhibit B DDU (ICC Incoterms 2000) to a place of destination that POZEN will
name within ********* after the Effective Date, and the up to ********* additional shipments set forth in the previous paragraph DDU (ICC Incoterms 2000) to a place of destination that POZEN will name in its request for such shipments. 

 


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 2. 








 EXHIBIT C 
  
 DESCRIPTION OF IND DELIVERABLES 
  
 All of the following, subject to Section 2.3 of the Agreement: 
  

	1)	all of Nycomed’s information and data specified in Schedule C-1 attached hereto and hereby incorporated by reference, to the extent in existence as of the Effective Date;


  

	2)	a copy of the global safety database (ADR and related information) established by or on behalf of Nycomed or its licensees in connection with the development and commercialization
of Existing Nycomed Products (the content of the safety database is the same as the contents of the Periodic Safety Update Reports); 

  

	3)	full copies of all communications, information and data filed by or on behalf of Nycomed (or its predecessor-in-interest) with the FDA, including a copy of the Nycomed IND, for any
dosage form and strength of products containing Lornoxicam, and any communications received by or on behalf of Nycomed (or its predecessor-in-interest) from the FDA relating to such products, to the extent in existence as of the Effective Date and
located at Nycomed’s facilities, excluding in any event any information, data and communications relating to the manufacture of Lornoxicam. Nycomed represents and warrants to POZEN as of the Effective Date that, to the best of Nycomed’s
knowledge, the communications, information and data located at Nycomed’s facilities constitute all of the communications, information and data filed by or on behalf of Nycomed (or its predecessor-in-interest) with, or received from, the FDA;


  

	4)	(a) to the extent available at Nycomed’s facilities as of the Effective Date, access at Nycomed’s facilities to all communications with any regulatory agencies
outside the United States relating to the safety or efficacy of Lornoxicam, and (b) full copies of the communications with the regulatory agencies outside the United States relating to the safety or efficacy of Lornoxicam specified in Schedule
C – 2 attached hereto and hereby incorporated by reference; 

  

	5)	written confirmation that an up-to-date DMF regarding the manufacture of LX Bulk Drug Substance has been filed with the FDA; 

  


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	6)	a copy of a letter to the FDA providing for the right of POZEN to reference the DMF described in the preceding clause; and 

  

	7)	a chart, to be updated annually until the filing of an NDA by POZEN, indicating each country where any Nycomed Product, including each dosage form thereof, is approved, pending
approval, or has been withdrawn. 

  
 Delivery schedule: 
  
 Nycomed will deliver to POZEN the materials set
forth on Schedule C-1 (excluding the materials listed in Section I. of such Schedule) within ********* after the Effective Date and will deliver the remaining materials set forth on this Exhibit C (excluding the materials set forth in
clause 4(a) above and any updates pursuant to clause (7) above) within ********* after the Effective Date. Nycomed will grant access to the materials listed in 4(a) and the appropriate documentation set forth in the first paragraph of
Schedule C-1 as soon as reasonably practicable (but no later than ********* from the Effective Date), whereupon such materials will be deemed to have been delivered. 
  
 Nycomed will ship all materials set forth on this Exhibit C DDU (ICC Incoterms 2000) to a place of destination that POZEN will name within
********* after the Effective Date. 
  


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 2. 








 SCHEDULE C-1 
  
 Nycomed will provide POZEN with the items listed in II. and III. below in written or electronic form. With respect to the
items listed in I. below, Nycomed will, except to the extent to be provided under Exhibit B, provide POZEN with access at Nycomed’s facilities to appropriate documentation containing such items, provided that Nycomed may redact any portions of
such documentation that is proprietary to Nycomed and relates to the Process. 
  
 I. LX BULK DRUG SUBSTANCE 
  

	 	A.	Description, Physical and Chemical Properties, and Structural Elucidation 

  

	 	1.	Description 

  

	 	2.	Physicochemical Characteristics 

  

	 	3.	Structure Elucidation 

  

	 	B.	Manufacturing Site 

  

	 	C.	Method of Manufacture 

  

	 	1.	Equipment 

  

	 	2.	Specifications and Analytical Test Methods for Starting Materials, Reagents, Solvents and Auxiliary Materials 

  

	 	3.	Synthesis 

  

	 	D.	Reference Standard 

  

	 	1.	Preparation 

  

	 	2.	Structure Elucidation 

  

	 	3.	Test Results 

  

	 	E.	Specifications and Analytical Test Methods 

  

	 	1.	Release Specifications and Analytical Test Methods 

  

	 	2.	Test Results 

  


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	 	F.	Related Substances 

  

	 	1.	Intermediates and Potential Impurities 

  

	 	2.	Impurity Profile 

  

	 	G.	Stability 

  

	 	1.	Stability Study Designs and Storage Conditions 

  

	 	2.	Stability Specifications and Test Methods 

  

	 	3.	Test Results 

  

	 	4.	Conclusion 

  

	 	H.	Packaging and Labeling 

  

	 	1.	Container/Closure System Components 

  

	 	2.	Representative Label 

  
 II. EXISTING NYCOMED PRODUCT 
  

	 	A.	Components 

  

	 	1.	Qualitative Formula 

  

	 	2.	Quantitative and Batch Formulae 

  

	 	B.	Specifications and Analytical Test Methods for Existing Nycomed Product Inactive Ingredients 

  

	 	C.	Manufacturer, Analytical Lab, and Packager 

  

	 	D.	Method of Manufacture and Packaging 

  

	 	1.	Production Operations 

  

	 	2.	In-Process Controls 

  

	 	3.	Equipment 

  


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	 	E.	Specifications and Analytical Test Methods for Existing Nycomed Product 

  

	 	1.	Release Specifications and Analytical Test Methods 

  

	 	2.	Test Results 

  

	 	F.	Stability 

  

	 	1.	Stability Study Designs and Storage Conditions 

  

	 	2.	Stability Specifications and Test Methods 

  

	 	3.	Degradation Products 

  

	 	4.	Test Results 

  

	 	5.	Conclusion 

  
 III. PLACEBO 
  

	 	A.	Components 

  

	 	1.	Placebo Qualitative Formula 

  

	 	2.	Placebo Quantitative and Batch Formulae 

  

	 	B.	Specifications and Analytical Test Methods for Placebo Ingredients 

  

	 	C.	Manufacturer and Packager 

  

	 	D.	Method of Manufacture and Packaging 

  

	 	1.	Production Operations 

  

	 	2.	In-Process Controls 

  

	 	3.	Equipment 

  

	 	E.	Specifications and Analytical Test Methods for Placebo 

  

	 	1.	Release Specifications and Analytical Test Methods 

  

	 	2.	Test Results 

  


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	 	F.	Stability 

  

	 	1.	Stability Study Design and Storage Conditions 

  

	 	2.	Stability Specifications and Analytical Test Methods 

  

	 	3.	Test Results 

  

	 	4.	Conclusion 

  


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 4. 








 EXHIBIT D 
  
 CHEMICAL STRUCTURE OF LORNOXICAM 
  
 

 
  
  


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 EXHIBIT E 
  
 DESCRIPTION OF NYCOMED IMPROVEMENT PRODUCT 
 DELIVERABLES 
  

	1)	Quantities, provided in bulk, of cGMP- and specification-compliant blinded supplies of Nycomed Improvement Products and matching placebos, as reasonably requested by POZEN; and


  

	2)	All of the following, to the extent reasonably requested by POZEN, and subject to Section 2.3 of the Agreement: 

  

	 	(a)	Nycomed’s specifications and analytical methods relating to any Nycomed Improvement Product and reference standards relating to LX Bulk Drug Substance;


  

	 	(b)	Nycomed’s stability data for LX Bulk Drug Substance and for any Nycomed Improvement Product; and 

  

	 	(c)	access at Nycomed’s facilities to Nycomed’s preclinical and clinical data relating to any Nycomed Improvement Product or LX Bulk Drug Substance. 


 
 Delivery schedule: 
  
 Within a reasonable time after receipt by Nycomed of POZEN’s reasonable request for any
of the foregoing materials, Nycomed will use commercially reasonable efforts to supply POZEN with the requested materials pursuant to 1) and 2) (a) and (b) and will grant POZEN access to the materials pursuant to 2) (c). 
  
 Nycomed will ship all materials set forth on this Exhibit E DDU (ICC Incoterms 2000) to a
place of destination named by POZEN. 
  


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 EXHIBIT F 
  
 DESCRIPTION OF SPECIFICATIONS 
  

Existing Nycomed Product: 
  

			
	4 mg Tablets	 	as specified in Schedule F-1 attached hereto and hereby incorporated by reference
		
	8 mg Tablets	 	as specified in Schedule F-2 attached hereto and hereby incorporated by reference
		
	8 mg Quick release tablets	 	as specified in Schedule F-3 attached hereto and hereby incorporated by reference
		
	8 mg Vials	 	as specified in Schedule F-4 attached hereto and hereby incorporated by reference
	
	Placebos to Existing Nycomed Products
		
	 	 	as specified and included in the above Schedules of the corresponding Existing Nycomed Product
		
	LX Bulk Drug Substance:	 	as specified in Schedule F-5 attached hereto and hereby incorporated by reference

  
 Nycomed Improvement Product: as specified by Nycomed from time to time in its sole discretion. 
  
 Placebo to Nycomed Improvement Product: as specified by Nycomed from time to time in its sole discretion. 
  


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 EXHIBIT G 
  
 LICENSED PATENTS 
  
 Lornoxicam substance 
  

									
	 Country

	  	 Pat./appl. No.

	  	Filing date

	  	Expiry

	  	SPC


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

  
 Lornoxicam QR 
  

											
	 Country

	  	 Pat./appl. No.

	  	Filing date

	  	Expiry

	  	Status

	  	SPC


					
	 Exclusive Territory
	  	 	  	 	  	 	  	 
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 Limited Territory
	  	 	  	 	  	 	  	 	  	 
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********

  
 ********* 
  


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 Lornoxicam for injection 
  

											
	 Country

	  	 Pat./appl. No.

	  	Filing date

	  	Expiry

	  	Status

	  	SPC


					
	 Exclusive Territory
	  	 	  	 	  	 	  	 
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
					
	 Limited Territory
	  	 	  	 	  	 	  	 
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********
						
	 *********
	  	 *********
	  	*********	  	*********	  	*********	  	*********

  


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 EXHIBIT H 
  
 DISCLOSURE OF PATENT APPLICATIONS AND COMMUNICATION 
  

			
	 Lornoxicam QR (US)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

	 *********
	  	 
		
	 Lornoxicam QR (CA)
	  	 
		
	 *********
	  	 *********

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

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

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

	 *********
	  	 
		
	 Lornoxicam QR (EA)
	  	 
		
	 *********
	  	 *********

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

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


  


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	Lornoxicam INJ. (CA)
		
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	 
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
		
	Lornoxicam INJ. (NO)	  	 
		
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	*********
	*********	  	 

  


	***	Portion for which confidential treatment requested. 

  
 2. 








 EXHIBIT I 
  
 LIST OF COUNTRIES EXCLUDED FROM MANUFACTURING LICENSE 
  
 ITALY 
  
 JAPAN 
  
 TURKEY 
  
 EGYPT 
  
 KOREA 
  
 SAUDI ARABIA 
  
 ECUADOR 







 Exhibit J 
  

FORM SUPPLY AGREEMENT FOR SUBLICENSEES 
  
 As set forth in Schedule J – 1 attached hereto and hereby incorporated by reference. 







 EXHIBIT K 
  
 DEFINITION OF CHANGES 
  
 The terms “Major Change”, “Moderate Change” and “Minor Change” used in Section 9.6 of the Agreement will have the
meanings set forth in the FDA’s November 1999 Guidance for Industry Change to an Approved NDA or ANDA and the FDA’s February 2001 Guidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis (Bulk Actives Postapproval Changes:
Chemistry, Manufacturing, and Controls Documentation), each as amended, and any successor regulations thereto. The term “Change” means either a Major Change, a Moderate Change or a Minor Change. 







 TABLE OF CONTENTS 
  

							
	 	  	 	  	 	  	PAGE


	 1.
	  	DEFINITIONS	  	2
			
	 2.
	  	INITIAL DEVELOPMENT PROGRAM	  	10
				
	 	  	 2.1
	  	Re-Analysis of Carcinogenicity Data	  	10
				
	 	  	 2.2
	  	Scope of Initial Development Program	  	10
				
	 	  	 2.3
	  	Nycomed Deliverables	  	11
				
	 	  	 2.4
	  	Grant of Development License	  	11
				
	 	  	 2.5
	  	Use of Nycomed Product	  	12
			
	 3.
	  	GRANT OF OPTION	  	12
				
	 	  	 3.1
	  	Option	  	12
				
	 	  	 3.2
	  	Option Period	  	13
				
	 	  	 3.3
	  	Exclusivity	  	13
			
	 4.
	  	LICENSES AND OTHER RIGHTS	  	13
				
	 	  	 4.1
	  	License Grants to POZEN	  	13
				
	 	  	 4.2
	  	Limitations; Exclusivity	  	14
				
	 	  	 4.3
	  	Option Grant to Nycomed	  	16
				
	 	  	 4.4
	  	Isomer Option	  	19
				
	 	  	 4.5
	  	Negative Covenants	  	21
			
	 5.
	  	DEVELOPMENT PROGRAM	  	21
				
	 	  	 5.1
	  	Development and Costs	  	21
				
	 	  	 5.2
	  	Supply of Materials	  	21
				
	 	  	 5.3
	  	Order Process for Materials	  	22
				
	 	  	 5.4
	  	Shipping	  	22
				
	 	  	 5.5
	  	Invoices	  	22
				
	 	  	 5.6
	  	Other Supply Provisions	  	23
				
	 	  	 5.7
	  	Use of Nycomed Product	  	23
				
	 	  	 5.8
	  	Access to Know-How	  	23
			
	 6.
	  	COMMERCIALIZATION	  	23
				
	 	  	 6.1
	  	Principles of Commercialization	  	23
				
	 	  	 6.2
	  	Regulatory Obligations	  	24
				
	 	  	 6.3
	  	Diligence	  	24

  

 -i- 








 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	  	PAGE


	 7.
	  	COMMERCIAL SUPPLY OF LX BULK DRUG SUBSTANCE	  	25
				
	 	  	 7.1
	  	Exclusivity of Supply of LX Bulk Drug Substance	  	25
				
	 	  	 7.2
	  	Optional Extension	  	26
				
	 	  	 7.3
	  	Optional Termination	  	26
				
	 	  	 7.4
	  	Supply Diligence	  	26
				
	 	  	 7.5
	  	Establishment of Alternate Source	  	27
				
	 	  	 7.6
	  	Failure to Supply; End of Exclusive Manufacturing Periods	  	27
				
	 	  	 7.7
	  	Supply Price	  	28
				
	 	  	 7.8
	  	Price Increases	  	28
				
	 	  	 7.9
	  	Forecasts	  	29
				
	 	  	 7.10
	  	Order Process	  	30
				
	 	  	 7.11
	  	Shipping	  	30
				
	 	  	 7.12
	  	Invoices	  	31
			
	 8.
	  	WARRANTIES; ACCEPTANCE AND REJECTION OF MATERIALS	  	31
				
	 	  	 8.1
	  	Product Warranty	  	31
				
	 	  	 8.2
	  	Process Warranty	  	32
				
	 	  	 8.3
	  	Certificates of Analysis	  	32
				
	 	  	 8.4
	  	Acceptance Testing	  	32
				
	 	  	 8.5
	  	Recalls	  	34
				
	 	  	 8.6
	  	Adverse Drug Events	  	34
			
	 9.
	  	QUALITY REGULATIONS	  	35
				
	 	  	 9.1
	  	Documentation and Record Keeping	  	35
				
	 	  	 9.2
	  	Inspections and Audits	  	35
				
	 	  	 9.3
	  	DMFs and Manufacturing Approvals	  	37
				
	 	  	 9.4
	  	Personnel	  	37
				
	 	  	 9.5
	  	Records	  	38
				
	 	  	 9.6
	  	Change Management	  	38
			
	 10.
	  	COMPENSATION	  	40
				
	 	  	 10.1
	  	Option Fee	  	40
				
	 	  	 10.2
	  	Option Period Milestones	  	40

  

 -ii- 








 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	  	PAGE


	 	  	10.3	  	Option Exercise Fee	  	40
				
	 	  	10.4	  	Marketing Approval Milestone Payments	  	40
				
	 	  	10.5	  	Royalties	  	40
				
	 	  	10.6	  	Payments and Reports	  	42
				
	 	  	10.7	  	Payment Method; Currency; Interest	  	42
				
	 	  	10.8	  	Taxes	  	43
				
	 	  	10.9	  	Audit Rights; Adjustments	  	43
			
	 11.
	  	INTELLECTUAL PROPERTY	  	44
				
	 	  	11.1	  	Ownership	  	44
				
	 	  	11.2	  	Disclosure of Patents	  	44
				
	 	  	11.3	  	Enforcement Rights	  	44
				
	 	  	11.4	  	Covenant	  	46
				
	 	  	11.5	  	Maintenance	  	46
			
	 12.
	  	REPRESENTATIONS AND WARRANTIES	  	46
				
	 	  	12.1	  	Mutual Representations and Warranties	  	46
				
	 	  	12.2	  	Representations and Warranties of Nycomed	  	47
				
	 	  	12.3	  	Limitation of Warranty	  	48
			
	 13.
	  	INDEMNIFICATION	  	48
				
	 	  	13.1	  	Indemnification by POZEN	  	48
				
	 	  	13.2	  	Indemnification by Nycomed	  	49
				
	 	  	13.3	  	Indemnification Procedures	  	49
				
	 	  	13.4	  	Insurance	  	50
			
	 14.
	  	LIABILITY	  	50
				
	 	  	14.1	  	Limitation	  	50
				
	 	  	14.2	  	Affiliates	  	51
			
	 15.
	  	CONFIDENTIALITY, PUBLICATIONS, PUBLICITY	  	51
				
	 	  	15.1	  	Confidential Information	  	51
				
	 	  	15.2	  	Treatment of Confidential Information	  	52
				
	 	  	15.3	  	Access	  	52
				
	 	  	15.4	  	Permitted Disclosures	  	52

  

 -iii- 








 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	  	PAGE


				
	 	  	15.5	  	Return of Confidential Information	  	53
				
	 	  	15.6	  	Confidentiality of the Agreement Terms	  	53
			
	16.	  	TERM AND TERMINATION	  	54
				
	 	  	16.1	  	Term of the Agreement	  	54
				
	 	  	16.2	  	Termination for Material Breach	  	54
				
	 	  	16.3	  	Expiration of Option Period	  	54
				
	 	  	16.4	  	Termination at Will	  	54
				
	 	  	16.5	  	Force Majeure	  	54
				
	 	  	16.6	  	Severability	  	55
				
	 	  	16.7	  	No Challenge	  	55
				
	 	  	16.8	  	Insolvency	  	55
			
	17.	  	CONSEQUENCES OF EXPIRATION AND TERMINATION	  	55
				
	 	  	17.1	  	Expiration	  	55
				
	 	  	17.2	  	Termination	  	55
				
	 	  	17.3	  	Accrued Claims	  	56
				
	 	  	17.4	  	Survival	  	56
			
	18.	  	DISPUTE RESOLUTION	  	57
			
	19.	  	MISCELLANEOUS	  	57
				
	 	  	19.1	  	Further Assurances	  	57
				
	 	  	19.2	  	Assignment	  	58
				
	 	  	19.3	  	Independent Contractors	  	58
				
	 	  	19.4	  	Waiver	  	58
				
	 	  	19.5	  	Amendment	  	59
				
	 	  	19.6	  	Severability	  	59
				
	 	  	19.7	  	Notice	  	59
				
	 	  	19.8	  	Force Majeure	  	60
				
	 	  	19.9	  	Counterparts	  	60
				
	 	  	19.10	  	Governing Law	  	60
				
	 	  	19.11	  	Construction	  	60
				
	 	  	19.12	  	English Language	  	61

  

 -iv- 








 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	 	PAGE


				
	 	  	 19.13
	  	Entire Agreement	 	61
				
	 	  	19.14	  	Purchase Orders	 	61
				
	 	  	19.15	  	V.A.T.	 	61

  

 -v- 








 SCHEDULE J-1 
  
 SUPPLY AGREEMENT 
  
 THIS SUPPLY AGREEMENT (the “Agreement”) is entered into as of the
     day of                     ,             
(the “Effective Date”), by and between NYCOMED DANMARK APS, a Danish corporation, located at Langebjerg 1, DK-4000 Roskilde, Denmark, on behalf of itself and its Affiliates (collectively,
“Nycomed”), and                     , a
             corporation, located at                     , on behalf of
itself and its Affiliates (collectively, “Buyer”). Nycomed and the Buyer are referred to in this Agreement individually as a “Party” and collectively as “Parties”. 

 
 RECITALS 
  
 A. By the License Agreement (as hereinafter defined) Nycomed Danmark ApS
granted to POZEN (as hereinafter defined) certain rights and licenses to develop, market and commercialize certain pharmaceutical products in certain countries, including POZEN’s right to grant and authorize the grant of up to one level of
further sublicenses. 
  
 B. By the Sublicense Agreement (as
hereinafter defined) the Buyer was granted a sublicense under the licenses granted by Nycomed Danmark ApS to POZEN in the License Agreement. 
  
 C. The License Agreement provides for the execution of a supply agreement between Nycomed Danmark ApS and the Buyer for LX Bulk Drug Substance (as
hereinafter defined). 
  


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 1. 








 AGREEMENT 
  
 In consideration of the mutual covenants contained in this Agreement and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the Parties agree as follows: 
  
 1. DEFINITIONS 
  
 The capitalized
terms used in this Agreement will have the meanings given to them in this Section 1 and throughout this Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.

  
 1.1 “Affiliate” means with respect to
.........., any corporation or other business entity which (i) is an affiliate of ......... pursuant to the Sublicense Agreement as hereinafter defined) and (ii) has, either directly or indirectly, any requirements of LX
Bulk Drug Substance (as hereinafter defined) or Lornoxicam (as hereinafter defined) (or any salts, solvates or polymorphs thereof) for the purposes provided for under Section 2.1 of this Agreement, and with respect to Nycomed Danmark ApS, any
corporation or other business entity which (i) is an affiliate of Nycomed Danmark ApS pursuant to the License Agreement (as hereinafter defined) and (ii) Nycomed Danmark ApS desires to involve in the performance of this Agreement. Each of
.......... and Nycomed Danmark Aps will notify the other in writing if and as soon as any such corporation or other business entity becomes an Affiliate under this Agreement and Nycomed Danmark Aps hereby notifies .......... that
such is the case in respect to Nycomed Austria GmbH, St. Peter-Straße 25, A-4020 Linz, Austria. 
  


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 2. 








 1.2 “cGMP” means current good manufacturing practices for medicinal
products established by regulations in the United States (including 21 CFR §§ 210 and 211, as amended, and any successor regulations thereto), and the corresponding rules, regulations, or guidelines in the European Union and Canada.

  
 1.3 “Commercially reasonable efforts”
means, with respect to a Party, those efforts, consistent with the exercise of prudent scientific and business judgment, to conduct a particular activity hereunder that would be applied to a similar activity by other companies in the pharmaceutical
industry. 
  
 1.4 “DMF” means a
drug master file filed in accordance with 21 CFR § 314.420 and maintained with the FDA or the equivalent thereof, as applicable, in jurisdictions outside the United States. 
  
 1.5 “Exclusive Manufacturing Period” means: [(a) with respect to [Insert
countries in Buyer’s Territory that are in Exclusive Territory], the period commencing on the Effective Date and continuing until the date five years after: [either (i) the date of first commercial sale of the first POZEN
Product sold in the United States by Buyer, if Buyer’s territory to commercialize such POZEN Product includes both the United States and Canada, or (ii) otherwise, the date of first commercial sale of the first POZEN Product sold anywhere
in the Exclusive Territory (as defined in the License Agreement) by Buyer]; and (b) with respect to [Insert countries in Buyer’s Territory that are in Limited Territory], the period commencing on the Effective Date and
continuing until the date five years after: [either 
  


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 3. 








 (i) the date of first commercial sale of the first POZEN Product sold in the United Kingdom, France or Germany by Buyer,
if Buyer’s territory to commercialize such POZEN Product includes one or more of those three countries; or (ii) otherwise, the date of first commercial sale of the first POZEN Product sold anywhere in the Limited Territory (as defined in
the License Agreement) by Buyer; provided, however, that the Parties may extend any Exclusive Manufacturing Period for successive one-year terms, upon terms to be agreed upon at such time by the Parties].] [TO BE REVISED BASED ON SPECIFIC
SUBLICENSEE]  
  
 1.6 “FDA”
means the United States Food and Drug Administration, or any successor agency. 
  
 1.7 “Latent Defect” means any failure of a shipment of LX Bulk Drug Substance or portion thereof to conform at the date of delivery to the Product Warranty (as defined in
Section 3.1 of this Agreement) that would not be discoverable prior to the deadline for notice of rejection under Section 3.5 of this Agreement upon reasonable physical inspection or standard testing of such LX Bulk Drug Substance in
accordance with standards in the pharmaceutical industry, including in any event testing for purity and assay according to the methods included in the Specifications. 
  
 1.8 “License Agreement” means the Development, Option and License Agreement entered into as
of the      day of May, 2003 by and between POZEN (as hereinafter defined) and Nycomed relating to the active drug substance known as Lornoxicam, as amended from time to time. 
  


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 4. 








 1.9 “Licensed Technology” has the meaning provided in the License Agreement. 

 
 1.10 “Lornoxicam” means the active drug
substance known as lornoxicam, having the chemical structure set forth in Exhibit A to this Agreement (attached hereto and hereby incorporated in this Agreement by reference). 
  
 1.11 “LX Bulk Drug Substance” means Lornoxicam in bulk form, conforming to the Specifications
(as hereinafter defined). 
  
 1.12
“Manufacturing Approval” means all filings, applications, licenses, permits, and other authorizations which are required for the manufacture of LX Bulk Drug Substance in compliance with applicable laws and regulations of
the country of manufacture. 
  
 1.13
“NDA” means a new drug application submitted to the FDA to obtain FDA approval for the marketing of a pharmaceutical product in the United States. 
  
 1.14 “POZEN” means POZEN Inc., a Delaware corporation located at 1414 Raleigh Road, Suite
400, Chapel Hill, NC 27517, and its Affiliates (as defined in the License Agreement), if any. 
  
 1.15 “POZEN Product” means any pharmaceutical product sublicensed to Buyer from POZEN or its sublicensee under the Sublicense Agreement (as hereinafter defined) that contains LX Bulk
Drug Substance or Lornoxicam (or any salts, solvates or polymorphs thereof) as an active drug substance. 
  


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 5. 








 1.16 “Process” has the meaning provided in the License Agreement.

  
 1.17 “Specifications” means the
specific chemical and physical properties pertaining to LX Bulk Drug Substance set forth on Exhibit B, subject to change by Nycomed from time to time in accordance with Section 9.6 of the License Agreement. [At time of signing, the
then-current specifications will be attached as Exhibit B.] 
  
 1.18 “Sublicense Agreement” means the sublicense agreement entered into as of the      day of
                    ,     , by and between Buyer and
                             in which Buyer was granted a sublicense under the licenses granted by
Nycomed to POZEN under the License Agreement. 
  
 1.19
“Territory” means [insert countries in Buyer’s licensed territory]. 
  
 2. SUPPLY OF LX BULK DRUG SUBSTANCE 
  
 2.1 Exclusivity. During the Exclusive Manufacturing Period(s), and
subject to Section 2.3 of this Agreement, Buyer will purchase from Nycomed and Nycomed will use commercially reasonable efforts to provide to Buyer, 100% of Buyer’s requirements of LX Bulk Drug Substance or Lornoxicam (or any salts,
solvates or polymorphs thereof), to be provided by Nycomed in the form of LX Bulk Drug Substance, for use in the manufacture of POZEN Products, except to the extent that Buyer obtains from POZEN all or any portion of such requirements that POZEN has
purchased from Nycomed. For purposes of clarification, for any POZEN 
  


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 6. 








 Product manufactured by or for Buyer for distribution in a particular country of the Territory after the Exclusive
Manufacturing Period applicable to such country, Buyer will have the right to source LX Bulk Drug Substance or Lornoxicam (or any salt, solvate or polymorph thereof) from any entity. 
  
 2.2 Supply Diligence. 
  
 (a) Nycomed will use commercially reasonable efforts to maintain a reasonable inventory of LX Bulk Drug Substance, at Nycomed’s expense, for
use in filling orders of LX Bulk Drug Substance conforming to the Specifications and as forecasted in the binding portion of a forecast by Buyer in accordance with this Agreement, at Nycomed. Similarly, Buyer will use commercially reasonable efforts
to maintain a reasonable inventory of LX Bulk Drug Substance supplied by Nycomed, at Buyer’s expense. 
  
 (b) If Nycomed has reason to believe that it will be unable to manufacture and fill a particular order made in accordance with this Agreement of LX
Bulk Drug Substance conforming to the Specifications despite the safeguards described in Section 2.2(a) above, then Nycomed will promptly notify Buyer of the cause for such projected shortfall and Buyer will have the right pursuant to
Section 2.3 of this Agreement to use an alternate source to supply the actual shortfall. 
  
 (c) If Nycomed has reason to believe that it will be unable, on an ongoing basis, to manufacture and fill orders by Buyer of LX Bulk Drug Substance conforming to the Specifications forecasted in accordance with
this Agreement, then Nycomed will notify Buyer of the cause for such projected shortfall, and use commercially reasonable efforts to establish a 
  


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 7. 








 contract manufacturer to manufacture such shortfall for Nycomed for supply to Buyer. Nycomed will not retain any contract
manufacturer that Nycomed has reason to believe would be unable to manufacture LX Bulk Drug Substance in accordance with the Product Warranty (as defined in Section 3.1 of this Agreement). If Nycomed has reason to believe that it will be unable
to establish, or establish in due time, such a contract manufacturer and to have manufactured such projected shortfall, then Nycomed will promptly notify Buyer thereof and Buyer will then have the right pursuant to Section 2.3 of this Agreement
to use an alternate source to supply the greater of: (i) *****, and (ii) *****, provided that Buyer shall use commercially reasonable efforts to *****. 
  
 2.3 Establishment of Alternate Source. 
  
 (a) During the Exclusive Manufacturing Period(s), Buyer will have the right to manufacture or have manufactured and
supplied to it LX Bulk Drug Substance for further processing into a POZEN Product by an alternate source to the extent Nycomed fails to supply Buyer’s requirement of LX Bulk Drug Substance as described in Section 2.2. 
  
 (b) If Buyer purchases from an alternate source a quantity of LX Bulk
Drug Substance that Nycomed failed to supply as described above and if such failure is related to *****, then, if the price paid by Buyer to such alternate source for such quantity of LX Bulk Drug Substance is *****, Nycomed will ***** Buyer the
***** of the ***** the supply ***** to the ***** and the *****, up to a ***** to ***** of the *****. 
  


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 8. 








 2.4 Supply Price. All supply of LX Bulk Drug Substance by Nycomed to Buyer for further processing
into POZEN Products will be made at the prices set forth on the following table: 
  

			
	 Quantity of LX Bulk Drug
 Substance ordered by Buyer *****:

	  	 Price per kg of LX Bulk Drug
 Substance:


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

  
 By way of example (and
assuming no price increases have occurred under the License Agreement or this Agreement), if Buyer orders, in one or more orders during a calendar year, ***** of LX Bulk Drug Substance for delivery, the price for *****. 
  
 2.5 Price Increases. If any changes to cGMP or any changes to
applicable laws or regulations are adopted after the Effective Date, and if Nycomed’s compliance with such changed cGMP, laws or regulations will result in an increase in the direct manufacturing costs of Nycomed for LX Bulk Drug Substance,
then Nycomed will promptly inform Buyer and may reasonably increase the prices set forth in Section 2.4 of this Agreement; provided, however, if any such price increase would lead to an increase of the prices set forth in
Section 2.4 of this Agreement of ***** of the prices set forth in Exhibit C to this Agreement, then Buyer will have the right to terminate this Agreement within ***** from receipt of Nycomed’s notification 
  


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 9. 








 of such price increase. Buyer’s notice of termination shall become effective between ***** from receipt by Nycomed
as specified in such termination notice (unless Nycomed reduces the price increase *****, and such price change and the effective date thereof are communicated to Buyer within ***** of receipt of Buyer’s notice), provided that Buyer will
continue to purchase LX Bulk Drug Substance during such period at the increased price and such increased price will be subject to any further price increases that result from additional changes to cGMP, laws or regulations during such period.

  
 2.6 Forecasts. No later than one calendar quarter prior
to the beginning of the calendar quarter in which Buyer desires the first delivery of LX Bulk Drug Substance from Nycomed under this Agreement (the “Initial Quarter”), Buyer will provide Nycomed with a forecast setting forth
Buyer’s requirements of LX Bulk Drug Substance for the 6 calendar quarters comprising the Initial Quarter and the 5 subsequent calendar quarters. Thereafter, on or before the first business day of each calendar quarter following the calendar
quarter in which the first forecast was provided by Buyer to Nycomed, Buyer will provide Nycomed with an updated rolling 6-calendar-quarter forecast. The quantities of LX Bulk Drug Substance set forth for the first 2 calendar quarters set forth in
any forecast will be binding on the Parties; provided, however, that the quantity of LX Bulk Drug Substance set forth in the second calendar quarter in any forecast will be greater than 85%, and less than 115%, of the quantity of LX Bulk Drug
Substance forecast for such calendar quarter in the previous forecast submitted by Buyer under this Section 2.6. All quantities of LX Bulk Drug 
  


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 10. 








 Substance set forth for the fourth through sixth calendar quarters in any forecast provided under this Section 2.6
are to be considered non-binding good faith estimates, and are provided to Nycomed only for preliminary planning purposes. The following table provides an example of the forecasts described by this Section 2.6: 
  

					
	 	 	 Forecast submitted on
 first business day,
             1Q2005            

	 	 Forecast
 submitted on first
 business day,
         2Q2005        


			
	 Quantity for delivery during 2Q2005
	 	 100kg
 (binding)
	 	 —  

			
	 Quantity for delivery during 3Q2005
	 	 200kg
 (binding)
	 	 200kg
 (binding)

			
	 Quantity for delivery during 4Q2005
	 	 300kg
 (non-binding)
	 	 300kg ± 15%
 binding)

			
	 Quantity for delivery during 1Q2006
	 	 350kg
 (non-binding)
	 	 400kg
 (non-binding)

			
	 Quantity for delivery during 2Q2006
	 	 400kg
 (non-binding)
	 	 200kg
 (non-binding)

			
	 Quantity for delivery during 3Q2006
	 	 400kg
 (non-binding)
	 	 700kg
 (non-binding)

			
	 Quantity for delivery during 4Q2006
	 	—  	 	 500 kg
 (non-binding)


  


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 11. 








 2.7 Order Process. Together with each forecast provided by Buyer pursuant to Section 2.6
above, Buyer will submit a purchase order to Nycomed for the quantities of LX Bulk Drug Substance in any binding forecasts that are not covered by a previous purchase order, specifying such quantities of LX Bulk Drug Substance and the delivery dates
thereof. Except with the prior agreement of Nycomed, Buyer will not designate in a purchase order less than ***** of LX Bulk Drug Substance for delivery on any particular delivery date. Nycomed will use commercially reasonable efforts to supply to
Buyer the quantities of LX Bulk Drug Substance ordered on the delivery dates set forth in a purchase order. 
  
 2.8 Shipping. Nycomed will package and label the LX Bulk Drug Substance for shipment in accordance with applicable law and in accordance with
Nycomed’s standard practices. Nycomed will ship the LX Bulk Drug Substance on the relevant purchase order FCA (ICC Incoterms 2000) either Nycomed’s facility in Linz, Austria or any other place named by Nycomed and by a carrier designated
by Buyer in the applicable purchase order. Each shipment will be made according to the schedule and in the amounts specified in the applicable purchase order and under the terms and conditions set forth in this Agreement. Each batch of LX Bulk Drug
Substance will be tested and Nycomed will enclose with each shipment of LX Bulk Drug Substance a material safety data sheet and a certificate of analysis in accordance with Section 3.3 of this Agreement. Nycomed will enclose any other required
shipping documentation with each shipment of 
  


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 12. 








 LX Bulk Drug Substance. Should Nycomed at any time during the term of this Agreement have reason to believe that it will
be unable to meet a delivery date of a shipment, Nycomed will promptly notify Buyer of the cause for such delay and the steps undertaken by Nycomed to avoid or minimize such delay. 
  
 2.9 Invoices. Nycomed will send an invoice to Buyer via facsimile upon transferring a shipment of LX Bulk Drug
Substance under this Agreement to the carrier designated by Buyer, and will enclose such invoice with each shipment of LX Bulk Drug Substance under this Agreement. Each such invoice will set forth a detailed account of the quantities and price of LX
Bulk Drug Substance included in such shipment. All invoices submitted to Buyer by Nycomed under this Agreement will be payable within ***** of invoice date. 
  
 3. WARRANTIES; ACCEPTANCE AND REJECTION OF LX BULK
DRUG SUBSTANCE 
  
 3.1
Product Warranty. Nycomed hereby warrants that at the date of delivery, any LX Bulk Drug Substance supplied by Nycomed under this Agreement will (i) conform to the Specifications, (ii) be manufactured in compliance with cGMP and the
applicable laws of the country of manufacture, (iii) not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, as amended (“FD&C Act”), (iv) conform to the applicable
DMF, (v) be manufactured in accordance with the Process, and (vi) comply with current USP and EP monographs and ICH guidelines (collectively, the “Product Warranty”). 
  


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 Failure of a delivery of LX Bulk Drug Substance to comply with clause (ii) of this Section 3.1 will not be
deemed a breach of the Product Warranty to the extent that such LX Bulk Drug Substance may, in accordance with applicable law, be used for the manufacture of POZEN Products for development, testing or commercial sale, as applicable. 
  
 3.2 [Subject to confirmation by Nycomed at time of signing]
Process Warranty. Nycomed hereby warrants that, as of the Effective Date, it has not been served with any interference action, litigation or other notice alleging that (i) the Process infringes the intellectual property rights of
any person or entity or (ii) that the Process constitutes a misappropriation of the trade secrets or other intellectual property rights of any person or entity within the Territory. 
  
 3.3 Certificates of Analysis. Nycomed will enclose a certificate of analysis with each shipment of LX Bulk Drug
Substance supplied hereunder. Such certificate of analysis will contain the results of the analysis of such LX Bulk Drug Substance conducted as required in the Specifications, and will certify with respect to each shipment and lot (identified by lot
number): (i) the quantity of the shipment, and (ii) that such LX Bulk Drug Substance conforms to the Product Warranty. 
  
 3.4 Acceptance Testing. If a shipment of a lot of LX Bulk Drug Substance or any portion thereof fails to conform to the Product Warranty, then
Buyer will have the right to either reject such nonconforming shipment of LX Bulk Drug Substance or the nonconforming portion thereof, as the case may be, in accordance with the terms set forth in this Section 3. 
  


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 3.5 Notice Period. 
  
 (a) Within ***** (or, in the case of the first shipment of LX Bulk Drug Substance under this Agreement, *****) after
delivery by Nycomed to Buyer of any shipment of any LX Bulk Drug Substance that does not conform, in whole or in part, with the Product Warranty, Buyer may give written notice to Nycomed of its rejection of either such shipment or portion thereof,
as the case may be, specifying the grounds for such rejection, and deliver to Nycomed samples of the rejected LX Bulk Drug Substance. If Buyer fails to give the aforesaid notice to Nycomed within the applicable period set forth above, then Buyer
will be deemed to have unconditionally accepted the applicable LX Bulk Drug Substance as in conformity with the Product Warranty, except as to Latent Defects. 
  

(b) Within ***** after Buyer’s discovery that a shipment of any LX Bulk Drug Substance or portion thereof contains a Latent Defect, Buyer
may give written notice to Nycomed of its rejection of either such shipment or portion thereof, as the case may be, specifying the grounds for such rejection, and deliver to Nycomed samples of the rejected LX Bulk Drug Substance. If Buyer fails to
give the aforesaid notice to Nycomed within the applicable period set forth above, Buyer will be deemed to have unconditionally accepted the applicable LX Bulk Drug Substance as free of the identified Latent Defect. 
  
 3.6 Disputes Regarding Conformity. After receipt of a rejection notice
and samples from Buyer pursuant to the preceding Section 3.5, Nycomed will be permitted, for a period of *****, to analyze the LX Bulk 
  


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 Drug Substance rejected by Buyer for nonconformity to the Product Warranty, and to present its findings with respect to
such LX Bulk Drug Substance to Buyer. If the Parties cannot agree on whether such LX Bulk Drug Substance conforms to the Product Warranty within ***** of Nycomed’s receipt of Buyer’s written notice of rejection and samples, then, as soon
as reasonably practicable, each Party will deliver samples of the LX Bulk Drug Substance in question to an independent laboratory selected by Nycomed as soon as reasonably practicable and reasonably acceptable to Buyer, and the independent
laboratory will analyze such samples according to the methods included in the Specifications and determine whether or not such LX Bulk Drug Substance conforms to the Product Warranty. Nycomed will use commercially reasonable efforts to cause the
independent laboratory to complete such analysis as soon as reasonably practicable. The definitive result of such analysis by the independent laboratory will be binding on the Parties. The cost of such analysis will be borne by the Party whose
assessment was incorrect. 
  
 3.7 Remedies. If Buyer
rejects a shipment of LX Bulk Drug Substance and Buyer and Nycomed agree, or the independent laboratory determines, that such shipment of LX Bulk Drug Substance does not conform to the Product Warranty, such nonconforming LX Bulk Drug Substance will
be held for Nycomed’s disposition, or will be returned to Nycomed (unless prohibited by applicable laws or regulations), in each case at Nycomed’s expense, as directed by Nycomed. Nycomed will use commercially reasonable efforts to replace
each nonconforming shipment of LX Bulk Drug Substance, or the nonconforming portion thereof on a 
  


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 batch-by-batch basis, with conforming LX Bulk Drug Substance as soon as reasonably practicable or will promptly provide
Buyer with a credit therefor, at Buyer’s election. 
  
 3.8
Notice of Latent Defects. If Nycomed becomes aware of a Latent Defect in any shipment of LX Bulk Drug Substance or portion thereof, Nycomed will immediately notify Buyer as to the shipment involved, and, at Buyer’s election (to be
communicated to Nycomed within *****), either such shipment or portion thereof, as the case may be, will be deemed rejected as of the date of Buyer’s communication, and such nonconforming LX Bulk Drug Substance will be held for Nycomed’s
disposition, or will be returned to Nycomed (unless prohibited by applicable laws or regulations), in each case at Nycomed’s expense, as directed by Nycomed. Nycomed will use commercially reasonable efforts to replace each nonconforming
shipment, or the nonconforming portion thereof, with conforming LX Bulk Drug Substance as soon as reasonably practicable, or will promptly provide Buyer with a credit therefor, at Buyer’s election. 
  
 3.9 Recalls. If a Party believes it may be necessary to conduct a
recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any POZEN Product (a “Recall”), Nycomed and Buyer will consult with each other as to how best to proceed, it being
understood and agreed that the final decision as to any such Recall with respect to a POZEN Product will be made by Buyer and the final decision as to any such Recall with respect to LX Bulk Drug Substance that has not yet been processed into a
POZEN Product will be made by Nycomed. 
  


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 3.10 Adverse Drug Events. Any adverse drug event or reaction complaint reports or any other
reports or information received by Buyer indicating that any POZEN Product has any toxicity, sensitivity reaction, or is otherwise alleged to cause illness or injury of any kind or is adulterated or misbranded, which toxicity, sensitivity reaction,
illness or injury is caused or alleged to be caused by the LX Bulk Drug Substance contained therein, will be reported promptly by Buyer to Nycomed, or as otherwise may be required under any applicable laws, rules or regulations, with copies of any
such written reports, and Nycomed will thereafter expeditiously investigate the information contained in such reports and communicate such results promptly to Buyer upon conclusion of such investigation. Buyer will copy Nycomed on all correspondence
with regulatory authorities relating to adverse drug events in relation to the LX Bulk Drug Substance supplied by Nycomed or any POZEN Products. 
  
 4. QUALITY REGULATIONS 
  
 4.1 Documentation and Record Keeping. Nycomed will keep complete, accurate and authentic accounts, notes, data and
resources of all of work performed by Nycomed related to LX Bulk Drug Substance under this Agreement, including, but not limited to, complete and adequate records pertaining to the methods and facilities used for the manufacture in accordance with
master production records, batch production records, product related documents (e.g., master formulae, validation packages, specifications, clinical trial batch related documents, batch specific deviation reports, certificates of analysis) and
standard operating procedures (“SOPs”). [Include only if sublicensee’s territory includes 
  


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 the U.S.:] [As soon as reasonably practicable following receipt of NDA approval for any POZEN
Product, Buyer shall provide Nycomed with written notice of the date of such NDA approval, which notice shall identify by lot number the lots of LX Bulk Drug Substance that correspond to such NDA approval, and Nycomed shall maintain such records
with respect to such lots of LX Bulk Drug Substance for a minimum of *****. With respect to each lot of LX Bulk Drug Substance supplied by Nycomed under this Agreement, Nycomed shall maintain such records for *****. Buyer will notify Nycomed in
writing of the expiration date of any POZEN Product and of any changes thereto. An SOP will be maintained for ***** after it is superseded or deleted. 
  
 4.2 Inspections and Audits. 
  
 (a) During the term of this Agreement, Buyer shall have the right to participate in inspections and audits of Nycomed’s facilities solely
through POZEN in accordance with Section 9.2.1 of the License Agreement. 
  
 (b) Nycomed will inform Buyer of the results of any inspection of Nycomed’s manufacturing facilities by a regulatory authority that could adversely affect the manufacture and supply of the LX Bulk Drug
Substance by Nycomed, regardless of whether or not such inspection was conducted in connection with the LX Bulk Drug Substance manufacture, at the conclusion of each calendar year (or earlier as expressly provided in this Agreement). If such an
inspection is in connection with the LX Bulk Drug Substance manufacture, Nycomed will additionally provide Buyer with a summary of the regulatory authority final report within ***** of Nycomed’s receipt of such report. 
  


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 (c) During any period in which Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed will
provide Buyer within ***** of receipt with copies of any Form No. 483 notification, Notice of Adverse Finding, or their analogous forms from any regulatory authorities, as well as any subsequent responses by Nycomed or the regulatory
authorities relating to the manufacture of LX Bulk Drug Substance or Nycomed’s manufacturing facilities used for such manufacture. Nycomed will have the right to redact from any documentation provided to Buyer under this Section 4.2(c) any
information that is specific to products other than the LX Bulk Drug Substance or that is related to the Process. 
  
 (d) During any period in which Nycomed is supplying LX Bulk Drug Substance hereunder, Nycomed agrees to inform Buyer within ***** of receipt of any
notice of inquiry or inspection with respect to a facility where LX Bulk Drug Substance is manufactured by any regulatory authority from a country in which Buyer plans to submit (as notified to Nycomed) or has submitted dossiers for regulatory
approval for POZEN Products containing LX Bulk Drug Substance (as notified to Nycomed) if such notice could adversely affect the manufacture or use of LX Bulk Drug Substance, and Nycomed will provide Buyer with copies of any written communications
received from regulatory authorities related to the manufacture of LX Bulk Drug Substance, and Nycomed may at its discretion redact any proprietary information relating to the Process or to products other than POZEN Products. 
  


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 4.3 Personnel. Neither Party will use in any capacity, in connection with any manufacturing or
other services to be performed under this Agreement, any individual who has been debarred pursuant to the FD&C Act or who is subject to an action, suit, claim, investigation or legal or administrative proceeding that could reasonably be expected
to lead to a debarment of Nycomed, Buyer or any person performing manufacturing or other services hereunder. Either Party will, if so requested by the other Party, prepare and submit a certification statement as necessary to satisfy the requirements
of the FD&C Act. Either Party agrees to immediately inform the other Party in writing if any person who is performing services hereunder is debarred or if such person becomes subject to an action, suit, claim, investigation or legal or
administrative proceeding that could lead to a debarment of such person. 
  
 4.4 DMFs and Manufacturing Approvals. Nycomed will be responsible for filing and maintaining at its expense, and will use commercially reasonable efforts to file and maintain, in such country(ies) of the
Territory coordinated by Nycomed and POZEN pursuant to the License Agreement, all DMFs necessary for the manufacture of LX Bulk Drug Substance supplied by Nycomed under this Agreement for clinical trials performed by Buyer and the commercial sale of
POZEN Products by Buyer after marketing approvals have been obtained for such POZEN Products. Nycomed will be responsible for filing and maintaining at its expense, and will use commercially reasonable efforts to file and maintain, the Manufacturing
Approval for LX Bulk Drug Substance supplied by Nycomed under this Agreement. 
  


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 4.5 Records. Nycomed will notify Buyer that Nycomed has submitted to regulatory authorities in the
Territory as required by applicable law any annual reports or updates in connection with the maintenance of DMFs under this Agreement within ***** of the filing of such reports or updates with any regulatory authority in the Territory. 

 
 4.6 Changes. Buyer acknowledges that Nycomed may make changes in
manufacturing materials, equipment, processes, procedures, or site, or to the Specifications or to the Process, for LX Bulk Drug Substance provided to Buyer under this Agreement in accordance with Section 9.6 of the License Agreement.

  
 5. NO INFORMATION, NO
LICENSE 
  
 Except as expressly provided for
in this Agreement, Nycomed shall have no obligation to provide any information, data, documentation or know-how to Buyer. Nothing in this Agreement shall be construed as granting the Buyer a license or right to use any information, data,
documentation or know-how which Nycomed was not obligated to provide to Buyer (but nevertheless provided to Buyer) or any of Nycomed’s patents or intellectual property rights other than patents. 
  
 6. REPRESENTATIONS AND WARRANTIES;
LIMITATION OF WARRANTY 
  
 6.1 Mutual Representations and Warranties. Each of the Parties hereby represents and warrants to the other Party as follows: 
  
 (a) such Party is a corporation duly organized, validly existing and in good standing under the laws of the state in
which it is incorporated; 
  


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 (b) this Agreement is a legal and valid obligation binding upon such Party and enforceable in
accordance with its terms, subject to applicable bankruptcy, reorganization, insolvency, moratorium and other laws affecting creditors’ rights generally from time to time in effect and to general principles of equity and the execution, delivery
and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a Party or by which it is bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it; 
  
 (c) it has the full power and authority to enter into this Agreement and to carry out the obligations contemplated hereby; and 
  
 (d) it has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement. 
  
 6.2 Representation of Buyer. Buyer hereby represents and warrants to
Nycomed that: 
  
 (a) Buyer is aware of all provisions of
the License Agreement that are relevant to the Parties’ rights and obligations under this Agreement; and 
  
 (b) Under the Sublicense Agreement, Buyer has the right to receive from POZEN copies, whether or not redacted, of amendments to the License
Agreement that are relevant to the Parties’ rights and obligations under this Agreement. 
  


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 6.3 DISCLAIMER. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
REPRESENTATION OR WARRANTY, AND EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF ANY THIRD PARTY’S PATENTS, OTHER INTELLECTUAL PROPERTY,
KNOW-HOW OR TRADE SECRETS, WITH RESPECT TO ANY MATERIALS (INCLUDING LX BULK DRUG SUBSTANCE), INFORMATION, OR DOCUMENTATION OR DATA PROVIDED TO THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT. 
  
 7. INDEMNIFICATION 
  
 7.1 Indemnification by Buyer. Buyer will indemnify, defend and hold
Nycomed and its directors, officers and employees (each a “Nycomed Indemnitee”) harmless from and against any damages, costs or expenses, including reasonable attorneys’ fees and expenses (collectively,
“Losses”) incurred by a Nycomed Indemnitee in connection with any claim, lawsuit or other action by a third party (“Third Party Claim”) to the extent such Losses arise out of, relate to or result from:
(a) the breach by Buyer of any of its representations, warranties, covenants or obligations contained within this Agreement; or (b) the gross negligence or willful misconduct of Buyer, its directors, officers or employees in connection
with this Agreement. Notwithstanding the foregoing, Buyer will have no obligation under this Section 7.1 with respect to any Losses for which a Buyer Indemnitee is entitled to indemnification pursuant to Section 7.2 of this Agreement.

  


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 7.2 Indemnification by Nycomed. Nycomed will indemnify, defend and hold Buyer and its directors,
officers and employees, (each a “Buyer Indemnitee”) harmless from and against any Losses incurred by a Buyer Indemnitee in connection with any Third Party Claim to the extent such Losses arise out of, relate to or result
from: (a) the breach by Nycomed of any of its representations, warranties, covenants or obligations contained within this Agreement, including the supply by Nycomed of LX Bulk Drug Substance that do not conform to the Product Warranty (except
to the extent Buyer did not perform reasonable physical inspection or standard testing of such LX Bulk Drug Substance in accordance with standards in the pharmaceutical industry, including in any event testing for purity and assay according to the
methods included in the applicable Specifications); or (b) the gross negligence or willful misconduct of Nycomed, its directors, officers or employees in connection with this Agreement. Notwithstanding the foregoing, Nycomed will have no
obligation under this Section 7.2 with respect to any Losses for which a Nycomed Indemnitee is entitled to indemnification pursuant to Section 7.1 of this Agreement. 
  
 7.3 Indemnification Procedures. A Party which or whose officers, directors or employees intend to claim
indemnification under Section 7.1 or 7.2 of this Agreement (the “Indemnitee”) will promptly notify the other Party (the “Indemnitor”) in writing of any claim, lawsuit or other action in respect of
which the Indemnitee or any of its directors, officers or employees intend to claim such indemnification as soon as reasonably practicable after the assertion of such claim; provided, however, that the failure to provide 
  


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 written notice of such claim as soon as reasonably practicable will not relieve the Indemnitor of any of its obligations
hereunder, except to the extent that the Indemnitor is prejudiced by such failure to provide prompt notice. For purposes of clarification, an officer, director or employee of a Party will not have the right to claim indemnification directly from the
other Party under this Section 7 and shall instead make any such claim solely through the Party employing such officer, director or employee; provided, however, that the foregoing shall not be construed to limit any right to
indemnification that any officer, director or employee of a Party may have other than under this Agreement (e.g., under applicable laws or regulations). The Indemnitor will have the right to assume the complete control of the defense, compromise or
settlement of any such claim with the prior written consent of such Indemnitee, which such consent will not be unreasonably withheld or restricted, or withdrawn or restricted at a later stage; provided, however, that Indemnitee will have the
right to withhold consent to any compromise or settlement in its sole discretion if such compromise or settlement includes any admission of wrongdoing on the part of an Indemnitee, or limits the scope of any claims in or enforceability of any
Patents owned by or licensed to the Indemnitee. Subject to the aforesaid, the Indemnitor may at its own expense, employ legal counsel to defend the claim at issue and at any time after Indemnitor has assumed defense of a claim, the Indemnitor may
exercise, on behalf of the Indemnitee, any rights which may mitigate the extent or amount of such claim; provided, however, the Indemnitee: (a) may, in its sole discretion and at its own expense, employ legal counsel to represent it (in
addition to the legal counsel employed by the Indemnitor) in any such matter, and in such 
  


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 event legal counsels selected by the Indemnitee and the Indemnitor will be required to confer and cooperate with each
other in such defense, compromise or settlement for the purpose of informing and sharing information; (b) will, at its own expense, make available to Indemnitor those employees, officers and directors of Indemnitee whose assistance, testimony
or presence is necessary, useful or appropriate to assist the Indemnitor in evaluating and in defending any such claim; provided, however, that any such access will be conducted in such a manner as not to interfere unreasonably with the
operations of the businesses of Indemnitee; and (c) will otherwise reasonably cooperate with the Indemnitor and its legal counsel in the investigation and defense of such claim. Notwithstanding any other provision of this Agreement to the
contrary, to the extent that a Party has indemnification rights under this Agreement as well as under the License Agreement or the Sublicense Agreement, as applicable, with respect to a particular item of Losses, such Party shall in no event be
entitled to recover more than 100% of the amount of such Losses in the aggregate under both such agreements. 
  
 7.4 Insurance. During the term of this Agreement *****, each Party will maintain commercially reasonable insurance coverage commensurate with its
obligations under this Agreement. 
  
 8. LIABILITY

  
 8.1 LIMITATION. IN NO EVENT WILL EITHER PARTY BE
LIABLE TO THE OTHER PARTY FOR INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF OR 
  


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 RELATING IN ANY WAY TO THIS AGREEMENT (EXCEPT WITH RESPECT TO THE PROVISIONS SET FORTH IN SECTIONS 7 AND 12 OF THIS
AGREEMENT), INCLUDING, BUT NOT LIMITED TO, ANY CLAIM FOR DAMAGES BASED UPON LOST PROFITS. 
  
 8.2 Affiliates. Each of ............ and Nycomed Danmark ApS will be responsible and liable to each other for any of its Affiliates’, contractors’ or consultants’ acts, performances,
omissions or failures to perform in connection with this Agreement, as if such acts, performances, omissions or failures were made by themselves. 
  
 9. TERM AND TERMINATION 
  
 9.1 Term. The term of this Agreement shall commence on the Effective Date and end upon the first to occur of: (i) the expiration of all
Exclusive Manufacturing Periods (including any extension thereof), or (ii) the termination of this Agreement as otherwise provided for in this Section 9. 
  
 9.2 Optional Termination. On or after January 1, 2014, either Party may provide the other Party with written
notice of its intention to terminate this Agreement, in which case this Agreement will terminate on the date 24 months after the date such notice is received by such other Party. 
  
 9.3 Termination for Material Breach. In the event of a material breach of this Agreement by either Party, the
non-breaching Party will have the right to terminate this Agreement by written notification to the other 
  


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 Party, effective immediately upon receipt, if such breach is not cured within ***** after receipt of written notice of
such breach from the non-breaching Party. 
  
 9.4 Failure to
Supply. Buyer will have the right to terminate this Agreement, effective immediately upon receipt of written notice of termination: 
  
 (a) upon the failure of Nycomed to supply for any reason, excluding force majeure, at least ***** of Buyer’s requirement of LX Bulk Drug
Substance conforming to the Specifications forecasted and ordered in accordance with this Agreement for any *****, or for *****, in each case, unless Nycomed remedies such shortfall either (i) within 30 days of the scheduled delivery date in
the case of failure to deliver at least ***** of ordered quantities of LX Bulk Drug Substance, or (ii) in accordance with either Section 3.7 or Section 3.8 (as applicable) in the case of failure of at least ***** of such LX Bulk Drug
Substance delivered to conform to the Specifications. The termination right set forth in this subsection (a) will expire with respect to a particular failure described above if not exercised within 30 days of the expiration of Nycomed’s
rights to remedy such failure; or 
  
 (b) upon the failure
of Nycomed to supply for any reason, excluding force majeure, at least ***** of Buyer’s requirement of LX Bulk Drug Substance conforming to the Specifications forecasted and ordered in accordance with this Agreement during any calendar year,
unless Nycomed remedies such shortfall either (i) within 30 days of the scheduled 
  


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 delivery date in the case of failure to deliver at least ***** of ordered quantities of LX Bulk Drug Substance, or
(ii) in accordance with Section 3.7 or Section 3.8 (as applicable) in the case of failure of at least ***** of such LX Bulk Drug Substance delivered to conform to the Specifications. The termination right set forth in this subsection
(b) will expire with respect to a particular failure described above if not exercised within 30 days of the expiration of Nycomed’s rights to remedy such failure. 
  
 9.5 Termination Of Sublicense Agreement Or License Agreement. This Agreement shall automatically terminate on the
effective date of any expiration or termination of the Sublicense Agreement (and the Buyer shall promptly notify such effective date to Nycomed), whether expired or terminated in its entirety or only with respect to the Licensed Technology, or the
License Agreement. 
  
 9.6 Force Majeure. The Party not
subject to force majeure will have the right to terminate this Agreement pursuant to Section 13.8 of this Agreement, effective immediately upon receipt of written notice of termination. 
  
 9.7 Severability. This Agreement may be terminated in accordance with
Section 13.6 of this Agreement. 
  
 9.8 Insolvency. If
either ...................or Nycomed Danmark ApS commences as a debtor any proceedings under any bankruptcy, insolvency, reorganization, dissolution or liquidation law or if any such proceedings are commenced against either
..................or Nycomed Danmark ApS, the other Party will have the right to terminate this Agreement, effective immediately upon receipt of written notice of termination. 
  


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 9.9 Price Increases. Buyer may terminate this Agreement in accordance with Section 2.5 of
this Agreement. 
  
 10. CONSEQUENCES OF
EXPIRATION OR TERMINATION 
  
 10.1 Accrued Claims. No expiration or termination of this Agreement will relieve any Party hereto from any liability which, at the time of such expiration or termination, has already accrued to such Party prior
to such expiration or termination or which is attributable to a period prior to such expiration or termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based
upon any event occurring prior to such expiration or termination. 
  
 10.2 Survival. In the event of expiration or termination of this Agreement, the following provisions will survive, together with the definitions of the defined terms used therein Sections 3.1, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 4.1,
5, 6.3, 7, 8, 10, 11, 12 and 13. All other provisions, including all rights and obligations thereunder, will terminate and be of no further force and effect (except to the extent necessary with respect to liabilities accrued prior to expiration or
termination as described in Section 10.1 above). 
  
 10.3
Cancellation of Right of Reference. If this Agreement expires or terminates for whatsoever reason, Nycomed will be entitled to promptly cancel with any regulatory authority (including the FDA) any Buyer right of reference to Nycomed’s DMFs.

  


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 11. DISPUTE RESOLUTION 
  
 11.1 The Parties will try to settle their differences amicably
between themselves. In the event of any controversy or claim arising out of or relating to any provision of this Agreement or the performance or alleged non-performance of a Party of its obligations under this Agreement
(“Dispute”), a Party may notify the other Party in writing of such Dispute. If the Parties are unable to resolve the Dispute within ***** of receipt of the written notice by the other Party, such dispute will be resolved
according to the procedures set forth elsewhere in this Agreement, or, absent such procedures, referred to the Chief Executive Officers of each of the Parties (or their respective designees) who will use their good faith efforts to resolve the
Dispute within ***** after such referral. Notwithstanding the aforesaid, a Party will not be obligated to comply with the procedures as provided in this Section 11.1 and may immediately invoke the procedures set forth in Section 11.2 if
such compliance might result in such Party’s claims becoming statute barred. 
  
 11.2 Any Dispute that is not resolved as provided in the preceding Section 11.1 will be finally settled under the Rules of Conciliation and Arbitration of the International Chamber of Commerce by one or
more arbitrators appointed in accordance with such Rules. The language of any such arbitration proceeding will be English, and any such arbitration proceeding will take place in Copenhagen, Denmark. Notwithstanding the 
  


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 foregoing, either Party shall have the right to pursue an action in a court of competent jurisdiction to obtain
injunctive or other equitable remedy, in order to preserve the status quo during the resolution of any Dispute under this provision. 
  
 12. CONFIDENTIALITY 
  
 12.1 Confidential Information. Any information or materials communicated by one Party to the other Party, or as to which one Party provides the
other Party with access, pursuant to this Agreement will be deemed “Confidential Information” of the disclosing Party if either (a) marked “confidential” or with a similar legend, or (b) if disclosed orally or visually,
if identified as being confidential at the time of such oral or visual disclosure, and thereafter reduced to writing, marked “confidential” or with a similar legend, and sent to the other Party within ***** of such oral or visual
disclosure, or (c) if the nature of such information or materials or circumstances of disclosure would suggest to a reasonable person that such disclosure was confidential, which will in any event apply to any information or materials that
Buyer accesses at Nycomed’s facilities. Notwithstanding the preceding sentence, “Confidential Information” will not be deemed to include information or materials that the receiving Party can demonstrate, by competent written proof:

  
 (a) At the time of disclosure is published or is
publicly known or otherwise in the public domain, other than through any act or omission by the receiving Party; 
  


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 (b) Was already known to the receiving Party, other than under an obligation of confidentiality or
non-use, prior to the time of disclosure by the disclosing Party; 
  
 (c) Is disclosed to the receiving Party in good faith, without an obligation of confidentiality, by a third party not under any obligation of confidence with respect to such information, after the time of disclosure by the disclosing
Party; or 
  
 (d) Is independently developed by employees
of the receiving Party who had no access to the disclosing Party’s Confidential Information. 
  
 12.2 Treatment of Confidential Information. The Parties agree that during the term of this Agreement and for ***** after the expiration or
termination of this Agreement for any reason whatsoever, a Party receiving Confidential Information of the other Party will: (a) treat any such Confidential Information disclosed to it by the other Party as strictly confidential; (b) not
disclose such Confidential Information to third parties without the prior written consent of the other Party, other than to the extent necessary in the performance of this Agreement to its contractors or any consultants, provided that such
disclosure be under confidentiality agreements with provisions substantially similar to those contained in this Agreement and further provided that the Party so disclosing Confidential Information shall be fully responsible and liable for any breach
of any such confidentiality agreement by any contractor or consultant; (c) not use such Confidential Information for purposes other than those authorized expressly herein; and (d) use reasonable efforts to prevent unauthorized access to
such Confidential Information. 
  


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 12.3 Access. Access to Confidential Information will be limited to those employees of the Party
receiving Confidential Information who reasonably require such Confidential Information in order to carry out activities authorized pursuant to this Agreement, provided that such access be under confidentiality agreements with provisions
substantially similar to those contained in this Agreement and further provided that such Party shall be fully responsible and liable for any breach of any such confidentiality agreement by any such employee. 
  
 12.4 Permitted Disclosures. Notwithstanding any other provision in
this Agreement, a receiving Party may disclose Confidential Information of the disclosing Party to the extent such disclosure is required by law or court order, provided that the receiving Party gives the disclosing Party prompt written notice of
the requirement to disclose and reasonably cooperates with the disclosing Party to seek a protective order or other restrictions on the disclosure of such Confidential Information of the disclosing Party. Any such required disclosure will be limited
only to that Confidential Information that is required to be disclosed and such disclosed Confidential Information will remain Confidential Information hereunder despite the required disclosure. 
  
 12.5 Return of Confidential Information. Upon termination or
expiration of this Agreement for any reason whatsoever, each Party hereto will return or destroy (and certify the destruction of), as instructed by the 
  


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 disclosing Party, all Confidential Information of the other Party in its possession to the other Party; provided,
however, that each Party may retain: (a) a single archival copy of the Confidential Information of the other Party solely for the purpose of determining the extent of disclosure of Confidential Information hereunder and assuring compliance
with the surviving provisions of this Agreement; and (b) subject to the non-use and non-disclosure provisions of this Section 12, any portion of the Confidential Information of the other Party which a Party is required by mandatory
applicable law to retain. 
  
 12.6 Confidentiality of the
Agreement Terms. Neither Party will disclose the terms of this Agreement to any third party without the prior written consent of the other Party; provided, however, that either Party may disclose the terms of this Agreement to actual or
prospective investors and corporate partners, to a Party’s accountants, attorneys, insurers and other professional advisors, and as required by applicable laws and regulations of the U.S. Securities and Exchange Commission and any stock
exchange on which a Party’s stock is traded. 
  
 13.
MISCELLANEOUS 
  
 13.1 Further
Assurances. At any time during the term of this Agreement, each Party will, at the request of the other Party, use reasonable efforts to: (a) deliver to the other Party such records, data or other documents consistent with the provisions of
this Agreement, and (b) take or cause to be taken all such other actions, as a Party may reasonably deem necessary in order for such Party to obtain the full benefits of this Agreement and the transactions contemplated hereby. 
  


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 13.2 Assignment. Neither ............. nor Nycomed Danmark ApS will assign its rights
or obligations under this Agreement to any third party, without the prior written consent of the other, except that either .................. or Nycomed Danmark ApS may assign such rights and obligations to a third party in
connection with a merger, consolidation, transfer or sale of all or substantially all of the assets (including those to which this Agreement relates) of the assignor. In addition, either ............. or Nycomed Danmark ApS may assign
its rights and obligations under this Agreement to an Affiliate without the prior written consent of the other; provided, however, that in the case of assignment to an Affiliate, the assignor will be responsible and liable for the compliance
of such Affiliate with this Agreement. All permitted assignments by either ............... or Nycomed Danmark ApS of any of its rights under this Agreement will be subject to all of the terms and conditions of this Agreement. All
successors, permitted assignees of either ............... or Nycomed Danmark ApS will be subject to, and will be bound by, all the terms and conditions of this Agreement. Any purported assignment not permitted under the terms of this
Agreement will be null, void, and of no effect. 
  
 13.3
Independent Contractors. The Parties hereto are independent contractors. Nothing contained herein will constitute either Party the agent of the other Party for any purpose whatsoever, or constitute the Parties as partners or joint venturers.
Employees of each Party remain employees of said Party and will be considered at no time agents of or 
  


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 owing a fiduciary duty to the other Party. Neither Party hereto will have any implied right or authority to assume or
create any obligations on behalf of or in the name of the other Party or to bind the other Party to any other contract, agreement or undertaking with any third party. 
  
 13.4 Waiver. The failure of either Party to enforce any provision of this Agreement at any time will not be construed
as a present or future waiver of such or any other provision of this Agreement. The express waiver by either Party of any provision or requirement hereunder will not operate as a future waiver of such or any other provision or requirement and will
be effective only if set forth in a written instrument signed by a duly authorized representative of the Party waiving such provision or requirement. 
  
 13.5 Amendment. The Parties hereto may amend, modify or alter any of the provisions of this Agreement, but such amendment, modification or
alteration will be valid and binding on either Party only if made by a written instrument that explicitly refers to this Agreement and that is signed by a duly authorized representative of each Party. 
  
 13.6 Severability. In the event that any provision in this Agreement
is held to be unlawful or invalid in any jurisdiction, the meaning of such provision will be construed to the greatest extent possible so as to render it enforceable. If no such construction can render such provision enforceable, it will be severed.
The remainder of this Agreement will remain in full force and effect, and the Parties will negotiate in good faith a reasonable substitute provision that is valid and enforceable in such jurisdiction. If the 
  


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 Parties are unable to agree on a substitute provision, and if a Party reasonably and in good faith determines that the
unlawful or invalid provision was an essential element of this Agreement without which such Party would not have entered into this Agreement, as evidenced by this Agreement as a whole, then such Party may terminate this Agreement by written notice
to the other Party, effective immediately upon receipt. 
  
 13.7 Notice. All notices hereunder must be given in writing and will be deemed given if delivered personally or by facsimile transmission (receipt confirmed), mailed by registered or certified mail (return receipt requested) with
postage prepaid, or sent by express courier service (FedEx or other reputable, internationally recognized courier service), to the Parties at the following addresses (or at such other address for a Party as will be specified by like notice; provided
that notices of a change of address will be effective only upon receipt thereof). 
  

							
	 	 	 If to Buyer:
	 	  


	 	 	 	 	  


	 	 	 	 	  


	 	 	 	 	Attention:	 	  


	 	 	 	 	Facsimile:	 	  



  


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 39. 









					
	 	 	 If to Nycomed:
	  	Nycomed Danmark ApS
	 	 	 	  	Langebjerg 1
	 	 	 	  	DK-4000 Roskilde
	 	 	 	  	Denmark
	 	 	 	  	Attention: Senior Vice President International Sales
	 	 	 	  	Facsimile: +45 46 75 69 04

  
 13.8 Force
Majeure. Neither Party will be deemed to be in breach of this Agreement as a result of default, delay or failure to perform by such Party which is due to any cause beyond the reasonable control of such Party, including without limitation fire,
earthquake, acts of God, severe weather, acts of war, strikes, lockouts or other labor disputes, riots, civil disturbances, actions or inactions of governmental authorities (except actions in response to a breach of applicable laws by such Party),
or epidemics. In the event of any such force majeure, the Party affected will promptly notify the other Party, will use commercially reasonable efforts to overcome such force majeure, and will keep the other Party informed with respect thereto. If
such force majeure continues for a period of more than 180 days and concerns a material obligation of a Party, the Party not subject to such force majeure may terminate this Agreement by written notice to the other Party, effective immediately upon
receipt. 
  
 13.9 Counterparts. This Agreement may be
executed by the Parties in one or more identical counterparts, all of which together will constitute this Agreement. If this Agreement is executed in counterparts, no signatory hereto will be bound until both Parties have duly executed a counterpart
of this Agreement. 
  


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 13.10 Governing Law. This Agreement will be governed by, and construed and interpreted in
accordance with, the laws of Denmark, with the exclusion of the United Nations Convention on Contracts for the International Sale of Goods, without giving effect to any choice of law rule that would cause the application of the laws of any
jurisdiction other than the internal laws of Denmark to the right and duties of the Parties. 
  
 13.11 Construction. Unless used in combination with the word “either,” the word “or” is used throughout this Agreement in the inclusive sense (and/or). The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including” as used herein will mean including,
without limiting the generality of any description preceding such term. This Agreement has been drafted and negotiated jointly by the Parties and will not be construed against a Party by virtue of such Party having drafted this Agreement or a
particular provision hereof. Unless expressly provided herein to the contrary, all time limits, notice periods, deadlines or the like described herein will be governed by the following parameters: (i) all time periods that are 5 days in length
or less will be deemed to be business days, and (ii) all time periods greater than 5 days in length will be deemed to be calendar days. 
  


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 13.12 English Language. This Agreement, including any Exhibits attached hereto, has been written
and executed in the English language. Any translation into any other language will not be an official version of this Agreement, and in the event of any conflict in interpretation between the English version and such translation, the English version
will control. 
  
 13.13 Entire Agreement. This Agreement
constitutes the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all prior and contemporaneous agreements, understandings and negotiations, whether oral or written, with respect to such subject matter.

  
 13.14 Purchase Orders. Notwithstanding anything to the
contrary in this Agreement, in the event of any conflict between the terms set forth in any purchase order submitted by Buyer hereunder and this Agreement, the terms of this Agreement shall prevail, and no purchase order that conflicts with the
terms of this Agreement will be binding on Nycomed. 
  
 13.15
V.A.T. All amounts to be paid by Buyer to Nycomed under this Agreement will be paid plus V.A.T. (if applicable). 
  
 [Remainder of page intentionally left blank. Signature page follows.] 
  


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 IN WITNESS WHEREOF, the Parties have
caused this Agreement to be executed as of the Effective Date by signature of their duly authorized representatives. 
  

			
	[BUYER]
		
	 By:
	 	  


	 Name:
	 	  


	 Title:
	 	  


	
	NYCOMED DANMARK A/S
		
	 By:
	 	  


	 Name:
	 	  


	 Title:
	 	  




  


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 43. 








 Exhibit A 
  

Chemical Structure of Lornoxicam 
  
 

 
  
  

 1. 








 Exhibit B 
  

Specifications 
  
 [To be attached at time of signing.] 
  

 1. 








 Exhibit C 
  

Original Prices Per Kilogram of LX Bulk Drug Substance 
 Under the License Agreement 
  

			
	 Quantity of LX Bulk Drug
 Substance ordered *****:

	  	 Original price per kg of LX
 Bulk Drug Substance:


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

  

 1. 








 SCHEDULE J-1 
  
 TABLE OF CONTENTS 
  

							
	 	  	 	  	 	  	PAGE


	 1.
	  	DEFINITIONS	  	2
			
	 2.
	  	SUPPLY OF LX BULK DRUG SUBSTANCE	  	6
				
	 	  	 2.1
	  	Exclusivity	  	6
				
	 	  	 2.2
	  	Supply Diligence	  	7
				
	 	  	 2.3
	  	Establishment of Alternate Source	  	8
				
	 	  	 2.4
	  	Supply Price	  	9
				
	 	  	 2.5
	  	Price Increases	  	9
				
	 	  	 2.6
	  	Forecasts	  	10
				
	 	  	 2.7
	  	Order Process	  	12
				
	 	  	 2.8
	  	Shipping	  	12
				
	 	  	 2.9
	  	Invoices	  	13
			
	 3.
	  	WARRANTIES; ACCEPTANCE AND REJECTION OF LX BULK DRUG SUBSTANCE	  	13
				
	 	  	 3.1
	  	Product Warranty	  	13
				
	 	  	 3.2
	  	[Subject to confirmation by Nycomed at time of signing] Process Warranty	  	14
				
	 	  	 3.3
	  	Certificates of Analysis	  	14
				
	 	  	 3.4
	  	Acceptance Testing	  	14
				
	 	  	 3.5
	  	Notice Period	  	15
				
	 	  	 3.6
	  	Disputes Regarding Conformity	  	15
				
	 	  	 3.7
	  	Remedies	  	16
				
	 	  	 3.8
	  	Notice of Latent Defects	  	17
				
	 	  	 3.9
	  	Recalls	  	17
				
	 	  	 3.10
	  	Adverse Drug Events	  	18
			
	 4.
	  	QUALITY REGULATIONS	  	18
				
	 	  	 4.1
	  	Documentation and Record Keeping	  	18
				
	 	  	 4.2
	  	Inspections and Audits	  	19
				
	 	  	 4.3
	  	Personnel	  	21
				
	 	  	 4.4
	  	DMFs and Manufacturing Approvals	  	21

  

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 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	  	PAGE


	 	  	 4.5
	  	Records	  	22
				
	 	  	 4.6
	  	Changes	  	22
			
	 5.
	  	NO INFORMATION, NO LICENSE	  	22
			
	 6.
	  	REPRESENTATIONS AND WARRANTIES; LIMITATION OF WARRANTY	  	22
				
	 	  	 6.1
	  	Mutual Representations and Warranties	  	22
				
	 	  	 6.2
	  	Representation of Buyer	  	23
				
	 	  	 6.3
	  	DISCLAIMER	  	24
			
	 7.
	  	INDEMNIFICATION	  	24
				
	 	  	 7.1
	  	Indemnification by Buyer	  	24
				
	 	  	 7.2
	  	Indemnification by Nycomed	  	25
				
	 	  	 7.3
	  	Indemnification Procedures	  	25
				
	 	  	 7.4
	  	Insurance	  	27
			
	 8.
	  	LIABILITY	  	27
				
	 	  	 8.1
	  	LIMITATION	  	27
				
	 	  	 8.2
	  	Affiliates	  	28
			
	 9.
	  	TERM AND TERMINATION	  	28
				
	 	  	 9.1
	  	Term	  	28
				
	 	  	 9.2
	  	Optional Termination	  	28
				
	 	  	 9.3
	  	Termination for Material Breach	  	28
				
	 	  	 9.4
	  	Failure to Supply	  	29
				
	 	  	 9.5
	  	Termination Of Sublicense Agreement Or License Agreement	  	30
				
	 	  	 9.6
	  	Force Majeure	  	30
				
	 	  	 9.7
	  	Severability	  	30
				
	 	  	 9.8
	  	Insolvency	  	30
				
	 	  	 9.9
	  	Price Increases	  	31
			
	 10.
	  	CONSEQUENCES OF EXPIRATION OR TERMINATION	  	31
				
	 	  	 10.1
	  	Accrued Claims	  	31
				
	 	  	 10.2
	  	Survival	  	31
				
	 	  	 10.3
	  	Cancellation of Right of Reference	  	31
			
	 11.
	  	DISPUTE RESOLUTION	  	32

  

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 TABLE OF CONTENTS 
 (CONTINUED) 
  

							
	 	  	 	  	 	  	PAGE


	 12.
	  	CONFIDENTIALITY	  	33
				
	 	  	 12.1
	  	Confidential Information	  	33
				
	 	  	 12.2
	  	Treatment of Confidential Information	  	34
				
	 	  	 12.3
	  	Access	  	35
				
	 	  	 12.4
	  	Permitted Disclosures	  	35
				
	 	  	 12.5
	  	Return of Confidential Information	  	35
				
	 	  	 12.6
	  	Confidentiality of the Agreement Terms	  	36
			
	 13.
	  	MISCELLANEOUS	  	36
				
	 	  	 13.1
	  	Further Assurances	  	36
				
	 	  	 13.2
	  	Assignment	  	37
				
	 	  	 13.3
	  	Independent Contractors	  	37
				
	 	  	 13.4
	  	Waiver	  	38
				
	 	  	 13.5
	  	Amendment	  	38
				
	 	  	 13.6
	  	Severability	  	38
				
	 	  	 13.7
	  	Notice	  	39
				
	 	  	 13.8
	  	Force Majeure	  	40
				
	 	  	 13.9
	  	Counterparts	  	40
				
	 	  	 13.10
	  	Governing Law	  	41
				
	 	  	 13.11
	  	Construction	  	41
				
	 	  	 13.12
	  	English Language	  	42
				
	 	  	 13.13
	  	Entire Agreement	  	42
				
	 	  	 13.14
	  	Purchase Orders	  	42
				
	 	  	 13.15
	  	V.A.T.	  	42

  

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