Execution Version
`
`
`
`AMENDED AND RESTATED
`COLLABORATION AND LICENSE AGREEMENT FOR THE UNITED STATES
`
`
`
`
`
`by and between
`
`
`
`POZEN INC.
`
`and
`
`ASTRAZENECA AB
`
`
`
`November 18, 2013
`
`EAST\66107683.2
`DC: 5005376-23
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`

`
`TABLE OF CONTENTS
`
`
`
`Page
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`5. 
`
`6. 
`
`7. 
`
`DEFINITIONS .................................................................................................................... 1 
`
`COLLABORATION GOVERNANCE ............................................................................ 11 
`2.1 
`Establishment ........................................................................................................ 11 
`2.2  Membership and Procedures ................................................................................. 12 
`2.3 
`Decision-Making ................................................................................................... 13 
`2.4 
`Operating Principles.............................................................................................. 14 
`
`[Intentionally Omitted] ..................................................................................................... 14 
`
`REGULATORY MATTERS ............................................................................................ 14 
`4.1 
`Responsibilities; Diligence ................................................................................... 14 
`4.2 
`Access to Filings ................................................................................................... 14 
`4.3 
`Interactions with Regulatory Authorities .............................................................. 14 
`4.4 
`Exchange of Know-How; Information Sharing .................................................... 15 
`4.5 
`Regulatory Audits ................................................................................................. 15 
`4.6 
`Adverse Event Reporting ...................................................................................... 15 
`4.7 
`Records and Reports ............................................................................................. 16 
`
`DEVELOPMENT AND COMMERCIALIZATION ....................................................... 16 
`5.1 
`Development and Commercialization ................................................................... 16 
`5.2 
`Regulatory Obligations during Commercialization .............................................. 16 
`5.3 
`Performance; Diligence ........................................................................................ 16 
`5.4 
`Threatened Removal ............................................................................................. 17 
`5.5 
`Compliance ........................................................................................................... 17 
`5.6 
`Branding; Trademarks; Domain Names; Trade Dress; Logos .............................. 17 
`5.7 
`Commercial Supply .............................................................................................. 18 
`
`[Intentionally Omitted] ..................................................................................................... 18 
`
`LICENSES ........................................................................................................................ 18 
`7.1 
`Licensed Technology ............................................................................................ 18 
`7.2 
`Trademarks ........................................................................................................... 18 
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`TABLE OF CONTENTS (cont’d)
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`Page
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`8. 
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`9. 
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`10. 
`
`11. 
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`7.3 
`7.4 
`7.5 
`
`Sublicenses ............................................................................................................ 18 
`Reservation of Rights; No Implied Licenses ........................................................ 19 
`Restrictive Covenant ............................................................................................. 19 
`
`FINANCIAL TERMS ....................................................................................................... 19 
`8.1 
`Royalties ............................................................................................................... 19 
`8.2 
`Payments and Sales Reporting .............................................................................. 21 
`8.3 
`Records; Audit ...................................................................................................... 22 
`8.4 
`Taxes ..................................................................................................................... 22 
`
`INTELLECTUAL PROPERTY ....................................................................................... 23 
`9.1 
`Prosecution and Maintenance of Licensed Patents ............................................... 23 
`9.2 
`Prosecution and Maintenance of Joint Patents ...................................................... 23 
`9.3 
`Ownership of Inventions ....................................................................................... 23 
`9.4 
`Disclosure ............................................................................................................. 24 
`9.5 
`Cooperation ........................................................................................................... 24 
`9.6 
`Enforcement of Licensed Patents .......................................................................... 24 
`9.7 
`Defense of Infringement Claims ........................................................................... 26 
`9.8 
`Patent Term Extension and Supplementary Protection Certificate ....................... 26 
`9.9 
`Consequence of Patent Challenge ......................................................................... 26 
`9.10  Patent Certifications .............................................................................................. 26 
`9.11  Patent Marking ...................................................................................................... 27 
`
`REPRESENTATIONS, WARRANTIES; COVENANTS ............................................... 27 
`10.1  POZEN Representations and Warranties .............................................................. 27 
`10.2  Reciprocal Representations and Warranties ......................................................... 27 
`10.3  DISCLAIMER OF WARRANTY ........................................................................ 28 
`10.4  POZEN Non-Compete .......................................................................................... 28 
`10.5  Other Covenants.................................................................................................... 28 
`
`CONFIDENTIALITY....................................................................................................... 28 
`11.1  Definition .............................................................................................................. 28 
`11.2  Exclusions ............................................................................................................. 29 
`11.3  Disclosure and Use Restriction ............................................................................. 29 
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`TABLE OF CONTENTS (cont’d)
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`Page
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`12. 
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`13. 
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`11.4  Authorized Disclosure .......................................................................................... 30 
`11.5  Use of Name ......................................................................................................... 30 
`11.6  Press Releases ....................................................................................................... 30 
`11.7  Terms of Agreement to be Maintained in Confidence.......................................... 31 
`
`TERM AND TERMINATION ......................................................................................... 31 
`12.1  Amended and Restated Effective Date ................................................................. 31 
`12.2  Term ...................................................................................................................... 32 
`12.3  Termination for Material Breach .......................................................................... 32 
`12.4  Termination for Cause .......................................................................................... 32 
`12.5  Consequences of Expiration and Termination ...................................................... 32 
`12.6  Termination for Insolvency................................................................................... 33 
`12.7  Effect of Bankruptcy ............................................................................................. 33 
`12.8  Formulation Technology ....................................................................................... 33 
`12.9  Survival ................................................................................................................. 34 
`
`INDEMNIFICATION AND INSURANCE ..................................................................... 34 
`13.1 
`Indemnification by POZEN .................................................................................. 34 
`13.2 
`Indemnification by Licensee ................................................................................. 34 
`13.3 
`Indemnification Procedure .................................................................................... 35 
`13.4  Expenses ............................................................................................................... 36 
`13.5 
`Insurance. .............................................................................................................. 36 
`
`14. 
`
`LIMITATION OF LIABILITY ........................................................................................ 36 
`
`15.  MISCELLANEOUS ......................................................................................................... 37 
`15.1  Assignment. .......................................................................................................... 37 
`15.2  Termination of Certain Rights Upon POZEN Change of Corporate Control ....... 37 
`15.3  Severability ........................................................................................................... 38 
`15.4  Governing Law; Dispute Resolution .................................................................... 38 
`15.5  Notices .................................................................................................................. 39 
`15.6  Entire Agreement; Modifications ......................................................................... 39 
`15.7  Relationship of the Parties .................................................................................... 40 
`15.8  Waiver ................................................................................................................... 40 
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`TABLE OF CONTENTS (cont’d)
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`Page
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`15.9  Counterparts .......................................................................................................... 40 
`15.10  No Benefit to Third Parties ................................................................................... 40 
`15.11  Further Assurance ................................................................................................. 40 
`15.12  No Drafting Party .................................................................................................. 40 
`15.13  Construction .......................................................................................................... 40 
`15.14  Assignment to Horizon ......................................................................................... 41 
`15.15  Amendment and Restatement; No Novation ........................................................ 41 
`
`
`SCHEDULES
`
`Schedule 1.43 – Licensed Patents
`
`Schedule 1.83 - Vimovo Trademarks
`
`Schedule 8.1.3 – Market Reduction Example
`
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`AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT
`FOR THE UNITED STATES
`
`THIS AMENDED AND RESTATED COLLABORATION AND LICENSE
`AGREEMENT FOR THE UNITED STATES (the “Agreement”) is made and entered into as
`of November 18, 2013 (the “Amended and Restated Execution Date”), by and between
`POZEN INC., a Delaware corporation having offices at 1414 Raleigh Road, Suite 400, Chapel
`Hill, North Carolina (“POZEN”), and ASTRAZENECA AB, a Swedish corporation having an
`office at SE-431 83, Mölndal, Sweden (“Licensee”). POZEN and Licensee each may be
`referred to herein individually as a “Party,” or collectively as the “Parties.”
`
`RECITALS
`
`A. WHEREAS, POZEN and Licensee are parties to that certain Collaboration and
`License Agreement, dated as of August 1, 2006 and as amended as of September 6, 2007,
`October 1, 2008 and September 16, 2013 (as amended, the “Original Agreement”);
`
`B. WHEREAS, Licensee is in discussions with Horizon Pharma USA, Inc.
`(“Horizon”) to divest Licensee’s (and its Affiliates’) rights to Products (as defined below) in the
`United States (such transaction, the “Divestiture”); and
`
`C. WHEREAS, to facilitate the proposed Divestiture, Licensee and POZEN desire
`to amend and restate the terms of the Original Agreement in two separate agreements: (a) this
`Agreement, which contains the terms and conditions pursuant to which Licensee (or its assignee)
`will have a license to POZEN’s intellectual property to manufacture, develop and commercialize
`the Products (as defined below) in the United States, which will be assigned to Horizon in
`connection with the Divestiture, and (b) another agreement that contains the terms and conditions
`pursuant to which Licensee (or its designee) will have a license to POZEN’s intellectual property
`to manufacture, develop and commercialize the Products throughout the world outside of the
`United States and Japan (the “ROW Agreement”).
`
`In consideration of the foregoing premises, the mutual promises and covenants set forth
`in this Agreement, and other good and valuable consideration, the receipt and sufficiency of
`which are hereby acknowledged, POZEN and Licensee hereby agree as follows:
`
`1.
`
`DEFINITIONS
`
`AGREEMENT
`
`When used in this Agreement, capitalized terms will have the meanings as defined below
`and throughout the Agreement. All financial and accounting terms not otherwise defined in this
`Agreement, whether capitalized or not, shall have the meanings assigned to them in accordance
`with generally accepted accounting principles based on
`International Accounting
`Standards/International Financial Reporting Standards as in effect from time to time (“IFRS”).
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`1.1
`“Adverse Event” means any adverse medical occurrence in a patient or clinical
`investigation subject that is administered a pharmaceutical product, as designated under 21 CFR
`§ 312.32 and any other Applicable Law in the Territory.
`
`1.2
`“Affiliate” means a legal entity that, directly or indirectly, through one or more
`intermediaries, controls, is controlled by, or is under common control with an entity. For
`purposes of this definition only, “control” and, with correlative 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; provided, that if local law restricts foreign ownership, control will be
`established by direct or indirect ownership of the maximum ownership percentage that may,
`under such local law, be owned by foreign interests.
`
`1.3
`Section 12.1.
`
`1.4
`preamble.
`
`“Amended and Restated Effective Date” has the meaning set forth in
`
`“Amended and Restated Execution Date” has the meaning set forth in the
`
`1.5
`“Applicable Law” means the laws, rules, and regulations, including any statutes,
`rules, regulations, guidelines, or other requirements that may be in effect from time to time and
`apply to the activities contemplated by this Agreement in the Territory.
`
`1.6
`“Blocking Patent” means a Patent owned or controlled by a Third Party, one or
`more Valid Claims of which, in the absence of a license thereunder, would be infringed by the
`making, use, sale, offering for sale, or importation of a POZEN Product in the Territory.
`
`1.7
`“Business Combination” means any merger, consolidation, sale of stock, sale or
`transfer of all or substantially all of the assets, or other similar transaction to which POZEN is a
`party, other than (i) any merger, consolidation, or similar transaction following which the
`individuals and entities who were the beneficial owners of the outstanding voting securities of
`POZEN immediately prior to such transaction still beneficially own, directly or indirectly, more
`than fifty percent (50%) of the voting power of the surviving entity immediately after such
`transaction; or (ii) any merger, consolidation, sale of stock, sale or transfer of all or substantially
`all of the assets, or other similar transaction permitted under Section 15.1 (Assignment).
`
`1.8
`“Business Day” means any day other than (i) Saturday or Sunday or (ii) any other
`day on which banks in New York, New York, United States, the United Kingdom or Sweden are
`permitted or required to be closed.
`
`1.9
`“Calendar Quarter” means the respective periods of three (3) consecutive
`calendar months ending on March 31, June 30, September 30 and December 31.
`
`1.10 “cGCP” means current good clinical practices as defined in U.S. Regulations 21
`CFR §§ 50, 54, 56, 312 and 314, (or in the case of foreign jurisdictions, comparable regulatory
`standards), the International Conference of Harmonization (ICH) E6 “Good Clinical Practice:
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`Consolidated Guidance,” and in any successor regulation or any official guidance documents
`issued by an applicable Regulatory Authority.
`
`“cGLP” means cmrent good laboratory practice standards as defmed by the FDA
`1.11
`pursuant to 21 CFR Part 58 (or in the case of foreign jurisdictions, comparable regulatory
`standards), and m any successor regulation or any official guidance documents issued by a
`Regulatory Authority.
`
`“cGMP” means crurent good manufacturing practices as contained in 21 CFR
`1.12
`Parts 210 and 211 as amended from time to time and any equivalents contained in regulations in
`countries outside the U.S.
`
`1.13
`following:
`
`“Change of Corporate Control” means the occrurence of either of the
`
`(a)
`
`a Business Combination involving POZEN; or
`
`(b)
`the acquisition (whether in a single transaction or series of related
`transactions after the Effective Date by a Third Party or Group of beneficial ownership of2
`of POZEN’s voting securities.
`
`1.14
`
`“Combination Product” means
`
`a Product
`
`that
`
`includes one or more
`
`pharmaceutically active ingredients (in addition to a single Gastroprotective Agent and a single
`NSAID) and is sold in final form either in a single fixed combination oral solid dosage or as
`separate doses m a single package and priced as one item.
`
`“Commercial Launch” means the nationwide commercial sale, promotion and
`1.15
`distribution of POZEN Product in the Territory following receipt of Marketing Approval in the
`Territory.
`
`“Commercialization” means all activities relating to the manufacture, marketing,
`1.16
`promotion, advertising, selling and distribution of Product
`in the Territory,
`including pre-
`Commercial Launch market development activities conducted in anticipation of Marketing
`Approval of Product, including, without limitation, seeking pricing and reimbursement approvals
`for Product, preparing advertising and promotional materials, sales force training, and all
`interactions and activities (e.g., dossier preparations and filings) associated with Regulatory
`Authorities regarding the commercialization of Product and the maintenance of Marketing
`Approvals. The term “Commercialize” has a correlative meaning.
`
`“Commercialized POZEN Product” has the meaning set forth in Section 12.8
`1.17
`(Formulation Technology).
`
`to a particular Product being
`“Competing Product” means, with respect
`1.18
`Commercialized by Licensee or any of its Affiliates or Sublicensees in the Territory, a product
`being marketed by or on behalf of a Third Party other than a Sublicensee in the Territo
`containin at least
`
`those in the
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`1.19 “Controlled” means, with respect to any Know-How, Patent, or other intellectual
`property right, the possession of the right, whether directly or indirectly, and whether by
`ownership, license or otherwise, to assign, or grant a license, sublicense or other right to or
`under, such Know-How, Patent or right as provided for herein without violating the terms of any
`agreement or other arrangements with any Third Party.
`
`1.20 “Develop” or “Development” means all activities relating to pre-clinical and
`clinical development of a Product and all development activities relating to the preparation and
`filing of NDAs and obtaining of Marketing Approvals, price and reimbursement approvals in the
`Territory, including, without limitation, preparing and conducting pre-clinical testing, toxicology
`testing, human clinical studies, regulatory affairs.
`
`1.21 “Diligent Efforts” means, with respect to the Development, Manufacture or
`Commercialization by Licensee of a product, at any given time as the case may be, efforts and
`resources reasonably used by Licensee or its Affiliates (giving due consideration to relevant
`industry standards) for Licensee’s own products (including internally developed, acquired and
`in-licensed products) with similar commercial potential at a similar stage in their lifecycle
`(assuming continuing development of such product), taking into consideration their safety,
`tolerability and efficacy, the profitability (taking into account any payments payable under this
`Agreement or the Three-Party Agreement), the extent of market exclusivity, patent protection,
`cost to develop the product, promotable claims, and health economic claims.
`
`1.22 “Divestiture” has the meaning set forth in the recitals.
`
`1.23 “Duexis” means the pharmaceutical product containing ibuprofen and famotidine
`in a single fixed combination dosage form, which product is being commercialized as of the
`Amended and Restated Effective Date by Horizon or its Affiliates in the Territory as Duexis®.
`
`1.24 “Effective Date” means the date on which the Original Agreement became
`effective pursuant to the terms thereof.
`
`1.25 “Esomeprazole” means that certain pharmaceutical compound with the name (5-
`methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole),
`including any
`.
`
`1.26 “Execution Date” means August 1, 2006.
`
`1.27 “FDA” means the United States Food and Drug Administration, or any successor
`agency thereto.
`
`1.28 “Field of Use” means the treatment of human diseases and conditions by means
`of a pharmaceutical product.
`
`1.29 “First Commercial Sale” means, with respect to a Product, the date on which
`Licensee or its Affiliate or Sublicensee first sells the Product intended for commercial
`distribution to any Third Party after receipt of NDA Approval of such Product in the Territory
`(including, without limitation, sale in an individual state or similar sub-national political
`subdivision in which Marketing Approval may be received); provided, that with respect to the
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`Initial Pozen Product, “First Commercial Sale” means July 6, 2010. Sale of a Product for
`clinical studies, compassionate use, named patient programs, under a treatment IND, test
`marketing, any clinical studies, or any similar instance where the Product is supplied with or
`without charge will not constitute a First Commercial Sale.
`
`1.30 “Formulation Technology” means any Know-How Controlled by Licensee in
`the Licensee Inventions that are used by Licensee in the manufacture, use, sale or import of the
`formulation of a Commercialized POZEN Product, and any Patents Controlled by Licensee
`claiming such Licensee Inventions; provided, that Formulation Technology will not include any
`Patents or Know-How to the extent directed to a Gastroprotective Agent, non-steroidal anti-
`inflammatory, or other drug or chemical agent, or any methods of manufacture or use thereof.
`
`1.31 “Gastroprotective Agent” means proton pump inhibitors and H2 receptor
`antagonists for the treatment, prevention or amelioration of injury to the gastrointestinal tract.
`
`1.32 “Group” means a group of related persons or entities deemed a “person” for
`purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended.
`
`1.33 “Horizon” has the meaning set forth in the recitals.
`
`1.34 “IND” means an Investigational New Drug Application filed with the FDA
`pursuant to 21 CFR § 312.20.
`
`1.35 “Indirect Tax” means value added taxes, sales taxes, consumption taxes and
`other similar taxes.
`
`1.36 “Initial POZEN Product” means the POZEN Product containing non-enteric
`coated Esomeprazole and enteric-coated Naproxen that is the subject of NDA #22-511.
`
`1.37 “Invention” means any invention, discovery or Know-How that is conceived
`during the Term in the performance of activities undertaken pursuant to this Agreement by
`employees, agents, or independent contractors of either Party, its Affiliates or Sublicensees and
`is Controlled by such Party, Affiliates or Sublicensees.
`
`1.38 “Joint Invention” means any Invention that is conceived jointly by one or more
`employees, agents, or independent contractors of Licensee or its Affiliate(s) and one or more
`employees, agents, or independent contractors of POZEN or its Affiliate(s).
`
`1.39 “Joint Patent” means a Patent claiming a Joint Invention.
`
`1.40 “JSC” has the meaning set forth in Section 2.1.2 (Joint Steering Committee).
`
`1.41 “Know-How” means any non-public, documented or otherwise recorded or
`memorialized knowledge, experience, know-how, technology, information, and data, including
`formulas and formulations, processes, techniques, unpatented inventions, discoveries, ideas, and
`developments, test procedures, and results, together with all documents and files embodying the
`foregoing.
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`1.42 “Licensed Know-How” means any Know-How that is necessary or useful for the
`Development, Manufacture or Commercialization of Product in the Field of Use in the Territory
`and that is Controlled by POZEN or any of its Affiliates as of the Effective Date or during the
`Term.
`
`1.43 “Licensed Patents” means: (a) the Patents set forth on Schedule 1.43, and any
`substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations,
`confirmations, re-examinations, or extensions of such Patents, (b) any Patents in the Territory
`Controlled by POZEN or any of its Affiliates as of the Effective Date or during the Term that
`claim Inventions (including without limitation POZEN’s interest in Joint Inventions), and (c) all
`other Patents in the Territory Controlled by POZEN or any of its Affiliates as of the Effective
`Date or during the Term that are necessary or useful for the Development, Manufacture or
`Commercialization of a Product in the Territory. Notwithstanding anything in this Section 1.43
`to the contrary, Licensed Patents shall not include any Patents Controlled by POZEN with Valid
`Claims that do not cover any Product (e.g., any Patents with Valid Claims solely directed to any
`product containing acetyl salicylic acid).
`
`1.44 “Licensed Technology” means the Licensed Patents and the Licensed Know-
`
`How.
`
`1.45 “Licensee House Marks” means any trademarks, trade names, domain names, or
`other names or marks used or registered by Licensee or its Affiliates at any time during the Term
`to identify itself.
`
`1.46 “Licensee Invention” means any Invention that is conceived solely by one or
`more employees, agents, or independent contractors of Licensee or its Affiliate(s).
`
`1.47 “Manufacture” means all activities related to the manufacturing of a Product, or
`any ingredient thereof, in the Territory, including but not limited to formulation development and
`process development for the manufacture of a Product, manufacturing supplies for Development,
`manufacturing for commercial sale, packaging, in-process and finished product testing, release of
`product or any component or ingredient thereof, quality assurance activities related to
`manufacturing and release of product, ongoing stability tests and regulatory activities related to
`any of the foregoing. “Manufacture” shall not include any of the above activities with respect to
`Esomeprazole as an active ingredient.
`
`1.48 “Market Reduction” has the meaning set forth in Section 8.1.3 (Rate Step Down
`for Competing Product Entrants).
`
`1.49 “Marketing Approval” means all approvals (including NDA Approvals and,
`where available under Applicable Law, pricing and reimbursement approvals in accordance with
`Applicable Law) of any Regulatory Authority in the Territory, that are necessary or useful to be
`obtained prior to the manufacture or Commercialization of a Product in the Territory. For
`purposes of clarification, “Marketing Approval” in the U.S. shall have the same meaning as
`NDA Approval in the U.S.
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`1.50 “Naproxen” means that certain pharmaceutical compound with the chemical
`name (S)-6-methoxy-(alpha)-methyl-2-naphthaleneacetic acid, including any
`
`.
`
`1.51 “NDA” means a New Drug Application filed with the FDA as described in 21
`CFR § 314.
`
`1.52 “NDA Approval” means receipt of a letter from the FDA approving an NDA.
`
`1.53 “Net Sales” means with respect to any Product, the gross amounts recognized by
`Licensee, its Sublicensees or its Affiliates from Third Party customers for sales of a Product in
`the Territory, less the following deductions made by Licensee (to the extent not already taken by
`Licensee in the Product invoice or in amounts recognized), its Sublicensees or its Affiliates in
`arriving at net sales as reported in the Licensee statutory accounts prepared in accordance with
`IFRS:
`
`(a)
`actual credited allowances to such Third Party customers for spoiled,
`damaged, rejected, recalled, outdated and returned Product and for retroactive price reductions;
`
`(b)
`the amounts of trade and cash discounts actually granted to Third Party
`customers, to the extent such trade and cash discounts are specifically allowed on account of the
`purchase of such Product;
`
`(c)
`sales taxes, excise taxes and import/export duties actually due or incurred
`in connection with the sales of a Product to any Third Party customer;
`
`(d)
`allowances, adjustments, reimbursements, discounts, chargebacks and
`rebates actually granted to Third Party customers (not in excess of the selling price per unit of
`such Product);
`
`(e)
`other deductions from gross sales made in arriving at net sales as reported
`in the Licensee statutory accounts; and
`
`(f)
`transportation costs, distribution expenses, special
`for
`allowance
`packaging and related insurance charges in the amount of
` of the
`Net Sales calculated after applying the deductions of items (a)-(e) above.
`
`Net Sales shall be calculated using Licensee’s internal audited systems used to report such sales
`as adjusted for any of items (a)-(f) above not taken into account in such systems.
`Notwithstanding the foregoing, if Product is sold as a Combination Product, the Net Sales used
`for the calculation of the royalties under Section 8.1 (Royalties) shall be determined as follows:
`
` A
`A+B
`
`A =
`
`x
`
`Net Sales of the Combination Product, where:
`
`Standard Sales Price of the ready-for-sale form of the Product if sold
`separately from the Combination Product in question, in the Territory.
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`B =
`
`Standard Sales Price of the ready-for-sale form of a product containing
`the same amount of the other therapeutically active ingredient(s) that is
`contained in the Combination Product in question, in the Territory.
`
`
`If (a) the other therapeutically active ingredient(s) in such Combination Product are not sold
`separately in the Territory, Net Sales shall be adjusted by multiplying actual Net Sales of such
`Combination Product by the fraction A/C, where C is the Standard Sales Price in the Territory of
`such Combination Product, and (b) if a Product contained in the Combination Product is not sold
`separately, Net Sales shall be calculated by multiplying actual Ne