AstraZeneca / Pozen
`
`Collaboration and License Agreement
`
`August 1, 2006
`
`flaw/4 a
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`7%4, Cewfikdt
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`faces
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`ATTORNEYCONHDENHAL
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`Page 1 of 105
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`Mylan v. Pozen
`lPR2017-01995
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`Execution Copy
`
`COLLABORATION AND LICENSE AGREEMENT
`
`by and between
`
`POZEN INC.
`
`and
`
`ASTRAZENECA AB
`
`August 1. 2006
`
`ATTORNEY CONFIDENTIAL
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`TABLE OF CONTENTS
`
`Page
`
`1.
`
`2.
`
`DEFINITIONS ................................................................................................................. l
`
`COLLABORATION GOVERNANCE .......................................................................... 14
`
`2.1
`
`Establishment........................................................................................................ 14
`
`2.2 Membership and Procedures................................................................................. 15
`
`2.3 Decision-Making. ................................................................................................. l6
`
`3.
`
`PRODUCT DEVELOPMENT ....................................................................................... 18
`
`3.1 Development Plans. .............................................................................................. 19
`
`3.2 Core Development Activities ................................................................................ 19
`
`3.3 Additional Development Activities ....................................................................... 20
`
`3.4 Development of Products by AstraZeneca. ........................................................... 2]
`
`3.5 Oversight of Proof of Concept Studies .................................................................. 23
`
`36
`
`Exchange of Know-How ....................................................................................... 23
`
`3.7 Audits and Inspections .......................................................................................... 23
`
`4.
`
`REGULATORY MATTERS ......................................................................................... 24
`
`4.1
`
`Responsibilities; Diligence. .................................................................................. 24
`
`4.2 Access to Filings ................................................................................................... 26
`
`4.3
`
`4.4
`
`Interactions with Regulatory Authorities. ............................................................. 26
`
`Information Sharing .............................................................................................. 27
`
`4.5 Regulatory Audits ................................................................................................. 28
`
`4.6 Adverse Event Reporting ...................................................................................... 28
`
`5.
`
`COMMERCIALIZATION ............................................................................................. 29
`
`5.1 Commercialization ................................................................................................ 29
`
`5.2 Regulatory Obligations during Commercialization ............................................... 29
`
`5.3
`
`Performance; Diligence. ....................................................................................... 29
`
`5.4 Commercialization Plan ........................................................................................ 30
`
`5.5
`
`Threatened Removal ............................................................................................. 30
`
`5 .6 Compliance ........................................................................................................... 30
`
`5.7 Branding; Trademarks; Domain Names; Trade Dress; Logos. .............................. 31
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`6.
`
`MANUFACTURE OF POZEN PRODUCTS ................................................................ 31
`
`6.] Manufacturing Development. ............................................................................... 31
`
`6.2
`
`6.3
`
`Process Transfer.................................................................................................... 33
`
`Tenns for Clinical Supply..................................................................................... 34
`
`6.4 Commercial Supply .............................................................................................. 35
`
`6.5 Audits and Inspections.......................................................................................... 35
`
`6.6 Reference Rights; Support .................................................................................... 36
`
`7.
`
`LICENSES ..................................................................................................................... 36
`
`7.]
`
`Licensed Technology ............................................................................................ 36
`
`7.2 Trademarks ........................................................................................................... 37
`
`7.3
`
`Sublicenses ........................................................................................................... 37
`
`7.4 Reservation of Rights; No Implied Licenses ......................................................... 37
`
`7.5 Restrictive Covenant ............................................................................................. 37
`
`7.6
`
`Japan Option ......................................................................................................... 38
`
`8.
`
`FINANCIAL TERMS .................................................................................................... 38
`
`8.1 Upfront Fee ........................................................................................................... 38
`
`8.2 Development Milestone Payments ........................................................................ 38
`
`8.3
`
`Sales Milestone Payments ..................................................................................... 40
`
`8.4 Royalties. .............................................................................................................. 40
`
`8.5
`
`Payments and Sales Reporting. ............................................................................. 43
`
`8.6 Records; Audit ...................................................................................................... 44
`
`8.7
`
`Taxes. ................................................................................................................... 44
`
`9.
`
`INTELLECTUAL PROPERTY ..................................................................................... 45
`
`9.1
`
`9.2
`
`Prosecution and Maintenance of Licensed Patents ................................................ 45
`
`Prosecution and Maintenance of Joint Patents ...................................................... 45
`
`9.3 Ownership of Inventions ....................................................................................... 45
`
`9.4 Disclosure ............................................................................................................. 46
`
`9.5 Cooperation .......................................................................................................... 46
`
`9.6
`
`Enforcement of Licensed Patents .......................................................................... 46
`
`9.7 Defense of Infringement Claims ........................................................................... 47
`
`9.8
`
`Patent Term Extension and Supplementary Protection Certificate ........................ 48
`
`9.9 Consequence of Patent Challenge ......................................................................... 48
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`9.10 Patent Certifications .............................................................................................. 48
`
`9.11 Patent Marking ..................................................................................................... 49
`
`10. REPRESENTATIONS, WARRANTIES; COVENANTS ............................................. 49
`
`10.1 POZEN Representations and Warranties .............................................................. 49
`
`10.2 Notice of Developments ....................................................................................... 52
`
`10.3 AstraZeneca Warranties ........................................................................................ 52
`
`10.4 Reciprocal Representations and Warranties .......................................................... 52
`
`10.5 DISCLAIMER OF WARRANTY ........................................................................ 52
`
`10.6 POZEN Non-Compete .......................................................................................... 52
`
`10.7 POZEN Subcontractors ......................................................................................... 53
`
`10.8 Other Nexium Communications ........................................................................... 53
`
`10.9 Other Covenants. .................................................................................................. 53
`
`11. CONFIDENTIALITY. ................................................................................................... 54
`
`1 1.1 Definition .............................................................................................................. 54
`
`11.2 Exclusions ............................................................................................................. 54
`
`11.3 Disclosure and Use Restriction ............................................................................. 54
`
`11.4 Authorized Disclosure .......................................................................................... 55
`
`11.5 Use ofName ......................................................................................................... 56
`
`11.6 Press Releases ....................................................................................................... 56
`
`1 1.7 Terms of Agreement to be Maintained in Confidence .......................................... 56
`
`12.
`
`TERM AND TERMINATION ....................................................................................... 57
`
`12.1 HSR Act ............................................................................................................... 57
`
`12.2 Term ..................................................................................................................... 57
`
`12.3 Termination for Material Breach .......................................................................... 57
`
`12.4 Termination for Cause. ......................................................................................... 58
`
`12.5 Termination at Will ............................................................................................... 62
`
`12.6 Consequences of Expiration and Termination ....................................................... 62
`
`12.7 Termination for Insolvency ................................................................................... 66
`
`12.8 Effect of Bankruptcy ............................................................................................. 66
`
`12.9 Post Termination Royalties ................................................................................... 67
`
`12.10 Formulation Technology ....................................................................................... 67
`
`12.11 Survival ................................................................................................................ 67
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`I3.
`
`INDEMNIFICATION AND INSURANCE ................................................................... 68
`
`13.1 Indemnification by POZEN .................................................................................. 68
`
`13.2 Indemnification by AstraZeneca ........................................................................... 68
`
`13.3 Indemnification Procedure .................................................................................... 68
`
`13.4 Expenses ............................................................................................................... 70
`
`13.5 Insurance ............................................................................................................... 70
`
`14.
`
`LIMITATION OF LIABILITY ...................................................................................... 70
`
`15. MISCELLANEOUS ....................................................................................................... 70
`
`15.1 Assignment ........................................................................................................... 70
`
`[5.2 Termination of Certain Rights Upon POZEN Change of Corporate Control ........ 71
`
`15.3 Severabilily ........................................................................................................... 71
`
`15.4 Governing Law; Dispute Resolution ..................................................................... 72
`
`15.5 Notices .................................................................................................................. 73
`
`15.6 Entire Agreement; Modifications .......................................................................... 74
`
`15.7 Relationship of the Parties .................................................................................... 75
`
`15.8 Waiver .................................................................................................................. 75
`
`15.9 Counterparts.......................................................................................................... 75
`
`15.10No Benefit to Third Parties ................................................................................... 75
`
`15.1 1 Further Assurance ................................................................................................. 75
`
`15.12 No Drafting Party ................................................................................................. 75
`
`15.13 Construction .......................................................................................................... 75
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`EXHIBITS AND SCHEDULES
`
`Exhibit A — Formulation Budget
`
`Exhibit B — Initial U.S. Development Plan
`
`Exhibit C —U.S. Development Timeline
`
`Exhibit D — lnitial ROW Development Plan
`
`Exhibit E — ROW Development Timeline
`
`Exhibit F — TPP Studies
`
`Schedule 1.58 — Licensed Patents
`
`Schedule 4.1.2 — IMS MAT Data
`
`Schedule 6.1 — Initial POZEN Product Specifications
`
`Schedule 8.4.] — Segregated Royalty Example
`
`Schedule 8.4.3 — Market Reduction Example
`
`Schedule 10.] — Disclosure Schedule
`
`Schedule 10.7 — POZEN Subcontractors
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`COLLABORATION AND LICENSE AGREEMENT
`
`THIS COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is made
`and entered into effective as of August 1, 2006 (the “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, Molndal, Sweden (“Astraleneca”). POZEN and AstraZeneca each may be
`referred to herein individually as a “Party,” or collectively as the “Parties.”
`
`REC ITALS
`
`POZEN controls certain patents and other intellectual property pertaining to
`A.
`pharmaceutical products having gastroprotective agents in single fixed combination oral solid
`dosage form with non-steroidal anti-inflammatory drugs.
`
`AstraZeneca desires to obtain a license to POZEN’s intellectual property and to
`B.
`enter into a collaboration with POZEN for the purpose of developing and commercializing
`certain pharmaceutical products.
`
`POZEN desires to grant AstraZeneca such a license and to enter into such a
`C.
`collaboration on the terms and conditions set forth in this 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 AstraZeneca 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”).
`
`l.l
`
`“ADA Budget” has the meaning set forth in Section 3.3.3 (Expenses).
`
`“Additional Development Activities” means any activities related to the
`1.2
`Development of the Initial POZEN Product
`that are not Core Development Activities.
`Additional Development Activities agreed upon as of the Execution Date are included in the
`Initial U.S. Development Plan and lnitial ROW Development Plan.
`
`“Adverse Event” means any adverse medical occurrence in a patient or clinical
`. L3.
`_
`Investigation subject that is administered a pharmaceutical product, as designated under 21 CFR
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`§ 312.32 and any other Applicable Law in the Territory.
`
`“Affiliate” means a legal entity that, directly or indirectly, through one or more
`1.4
`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.
`
`“Applicable Law” means the laws, rules, and regulations. including any statutes,
`1.5
`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.
`
`trade names, domain
`“AstraZeneca House Marks" means any trademarks,
`1.6
`names, or other names or marks used or registered by AstraZeneca or its Affiliates at any time
`during the Term to identify itself.
`
`“Astraleneea Invention” means any Invention that is conceived solely by one
`1.7
`or more employees, agents, or independent contractors of AstraZeneca or its Affiliate(s).
`
`“Blocking Patent” means a Patent owned or controlled by a Third Party, one or
`1.8
`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.
`
`the Additional Development
`“Budgeted Development Activities” means
`1.9
`Activities described in the first ADA Budget approved by the GPT pursuant to Section 3.3.3
`(Expenses) and the first US. Development Plan and first ROW Development Plan approved by
`the GPT pursuant to Section 3.1 (Development Plans), in each case consistent with the Initial
`U.S. Development Plan and Initial ROW Development Plan.
`
`“Business Combination” means any merger, consolidation, sale of stock, sale or
`1.10
`transfer of all or substantially all of the assets, or other similar transaction to which POZEN is a
`party, other
`than any merger, consolidation, or similar
`transaction following which the
`individuals and entities who were the beneficial ovmers of the outstanding voting securities of
`POZEN immediately prior to such transaction still beneficially own, directly or indirectly, more
`than fifiy percent (50%) of the voting power of the surviving entity immediately after such
`transaction.
`
`“Business Day” means any day other than (i) Saturday or Sunday or (ii) any other
`1.11
`day on which banks in New York, New York, United States, the United Kingdom or Sweden are
`permitted or required to be closed.
`
`“Calendar Quarter” means the respective periods of three (3) consecutive
`1.12
`calendar months ending on March 31, June 30, September 30 and December 31.
`
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`“eGCP” means current good clinical practices as defined in US. Regulations 21
`1.13
`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:
`Consolidated Guidance," and in any successor regulation or any official guidance documents
`issued by an applicable Regulatory Authority.
`
`“cGLP” means current good laboratory practice standards as defined by the FDA
`1.14
`pursuant to 21 CFR Part 58 (or in the case of foreign jurisdictions, comparable regulatory
`standards), and in any successor regulation or any official guidance documents issued by a
`Regulatory Authority.
`
`“cGMP” means current good manufacturing practices as contained in 21 CFR
`1.15
`Parts 210 and 211 as amended from time to time and any equivalents contained in regulations in
`countries outside the US.
`
`1.16
`following:
`
`“Change of Corporate Control” means the occurrence of either of the
`
`(a)
`
`a Business Combination involving POZEN; or
`
`the acquisition (whether in a single transaction or series of related
`(b)
`transactions) after the Effective Date by a Third Party or Group of beneficial ownership of-
`— of POZEN’s voting securities.
`
`1.17
`
`“Clinical Trial Materials” means the Initial POZEN Product formulated in
`
`accordance with the specifications of Schedule 6.1, matching placebo and matching individual
`ingredients and comparators, each packaged and labeled for use in the applicable clinical trial.
`
`1.18
`
`“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 in a single package and priced as one item.
`
`“Commercial Launch” means the nationwide commercial sale, promotion and
`1.19
`distribution of POZEN Product
`in a particular country of the Territory following receipt of
`Marketing Approval in such country.
`
`“Commercialization” means all activities relating to the manufacture, marketing,
`1.20
`promotion, advertising, selling and distribution of Product
`in any country of 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.
`
`1.21
`
`“Commercialization Plan” has the meaning set forth in Section 5.4.1.
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`1.22
`
`“Commercialized POZEN Product" has the meaning set forth in Section
`
`12.6.4(b)(ii).
`
`to a particular Product being
`“Competing Product" means, with respect
`1.23
`Commercialized by AstraZeneca or any of its Affiliates or Sublicensees in any country of the
`Territory, a product being marketed by or on behalfof a Third Party (other than a Sublicensee) in
`
`the same country containing at least
`
`“Controlled” means, with respect to any Know-How, Patent, or other intellectual
`1.24
`the possession of the right. whether directly or indirectly, and whether by
`property right,
`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.
`
`“Core Development Activities” means any activities identified on Exhibit B as
`1.25
`being paid for by POZEN.
`
`“DDMAC” means the FDA’s Division of Drug Marketing, Advertising. and
`1.26
`Communications.
`
`“Develop" or “Development“ means all activities relating to prc-clinical and
`1.27
`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,
`including, without limitation, preparing and conducting pre-clinical testing, toxicology testing,
`human clinical studies, regulatory affairs.
`
`“Development Program” means the program of Development described in the
`l.28
`US. Development Plan and ROW Development Plan, each as amended from time to time.
`
`“Diligent Efforts” means, (A) with respect to the Development, Manufacture or
`1.29
`Commercialization by AstraZeneca of a product. at any given time as the case may be, efforts
`and resources reasonably used by AstraZeneca or its Affiliates (giving due consideration to
`relevant industry standards) for AstraZeneea’s own products (including intemally 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), the extent of market exclusivity, patent protection, cost to develop the
`product, promotable claims. and health economic claims, and (B) with respect
`to the
`Development by POZEN of a product, at any given time as the case may be, efforts and
`resources reasonably used by an entity in the pharmaceutical industry of similar resources and
`expertise as POZEN, for such similar entity’s own products (including internally developed,
`acquired and in-licensed products) with similar commercial potential at a similar stage in their
`Iifecycle (assuming continuing development of such product), taking into consideration their
`safety,
`tolerability and efficacy,
`the profitability (taking into account any payments payable
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`under this Agreement), the extent of market exclusivity, patent protection, cost to develop the
`product, promotable claims, and health economic claims.
`
`1.30
`“Direct Costs” means all amounts which POZEN disburses to vendors for
`services rendered or product supplied in conducting studies pursuant to this Agreement. For
`clarification, no POZEN employee compensation, internally consumed supplies, utility charges,
`recoverable Indirect Taxes or other indirect costs will be included in Direct Costs.
`
`1.31
`
`“Effective Date” has the meaning as defined in Section 12.1 (HSR Act).
`
`1.32
`
`“EMEA” means the European Medicines Agency, or any successor agency
`
`thereto.
`
`“Esomeprazole” means that certain pharmaceutical compound with the name (5-
`1.33
`methoxy-2-{(S)- 4-methox '-3,5-dimethvl
`'ridin-Z-yl)methyllsulfmyl}-l ll-benzimidazole),
`
`including any
`
`
`
`“FDA” means the United States Food and Drug Administration, or any successor
`1.34
`agency thereto.
`
`“Field of Use” means the treatment of human diseases and conditions by means
`1.35
`of a pharmaceutical product.
`
`“First Commercial Sale” means, with respect to a Product and on a country-by-
`1.36
`country basis, the date on which AstraZeneca or its Affiliate or Sublicensee first sells the Product
`intended for commercial distribution to any Third Party afier receipt of NDA Approval of such
`Product in such country (including, without limitation, sale in an individual state, province or
`similar sub-national political subdivision in which Marketing Approval may be received). 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.
`
`1.37
`
`“Formulation Budget” has the meaning set forth in Section 6.1.4 (Expenses).
`
`“Formulation Development Activities"
`1.38
`Section 6.1.4 (Expenses).
`
`has
`
`the meaning set
`
`forth
`
`in
`
`“Formulation Technology” means any Know-How Controlled by AstraZeneca
`1.39
`in the AstraZeneca Inventions that are used by AstraZeneca in the manufacture, use, sale or
`import of the formulation ofa Commercialized POZEN Product, and any Patents Controlled by
`AstraZeneca claiming such AstraZeneca 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.
`
`lied b the total number of
`“FTE Costs“ means an amount e ual to
`1.40
`onducting
`hours spent by POZEN development personnel
`Additional Development Activities for the Development of Initial POZEN Products pursuant to
`
`multi
`
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`this Agreement in accordance with a Development plan and budget approved by the GPT.
`
`“Gastroprotective Agent” means proton pump inhibitors and H2 receptor
`1.41
`antagonists for the treatment. prevention or amelioration of injury to the gastrointestinal tract.
`
`to
`team operating pursuant
`“GPT” means AstraZeneca’s global product
`1.42
`AstraZeneca’s instructions for global product
`teams for the Initial POZEN Product with
`representatives of AstraZeneca having expertisc in the areas of research & development,
`marketing, regulatory, intellectual property, finance, toxicology, and other areas.
`
`1.43
`
`“GPT Chair” will have the meaning set forth in Section 2.2.1 (GPT) .
`
`“Group” means a group of related persons or entities deemed a “person" for
`1.44
`purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended.
`
`“IND” means an lnvestigational New Drug Application filed with the FDA
`1.45
`pursuant
`to 21 CFR §312.20, or the corresponding filing in any country or regulatory
`jurisdiction other than the United States required for the clinical
`testing in humans of a
`pharmaceutical product.
`
`“Indirect Tax” means value added taxes, sales taxes, consumption taxes and
`1.46
`other similar taxes.
`
`“Initial POZEN Product” means the POZEN Product containing non-enteric
`1.47
`coated Esomeprazole and enteric-coated Naproxen that
`is
`the subject of the Initial U.S.
`Development Plan and Initial ROW Development Plan, subject to substitution (either throughout
`the Territory or in any one or more countries of the Territory) in accordance with Section 3.4.2
`(Substitution) hereof.
`
`“Initial ROW Development Plan” means the outline for the ROW Development
`1.48
`Plan, as set forth in Exhibit D as of the Effective Date.
`
`“Initial ROW Development Plan Timeline” means the ROW Development Plan
`1.49
`Timeline attached to this Agreement as Exhibit E as of the Effective Date.
`
`“Initial U.S. Development Plan” means the outline for the U.S. Development
`1.50
`Plan, as set forth in Exhibit B as of the Effective Date.
`
`“Initial U.S. Development Plan Timeline” means the U.S. Development Plan
`1.5]
`Timeline attached to this Agreement as Exhibit C as of the Effective Date.
`
`“Invention” means any invention, discovery or Know-How that is conceived
`1.52
`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.
`
`“Joint Invention” means any Invention that is conceived jointly by one or more
`1.53
`employees, agents, or independent contractors of AstraZeneca or its Affiliate(s) and one or more
`
`-6-
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`ATTORNEY CONFIDENTIAL
`Page 13 of 105
`
`P200002555
`Patent Owner Ex. 2067
`
`Mylan v. Pozen
`lPR2017-01995
`
`

`

`employees. agents, or independent contractors of POZEN or its Affiliate(s).
`
`1.54
`
`“Joint Patent” means a Patent claiming a Joint Invention.
`
`1.55
`
`“JSC” has the meaning set forth in Section