AstraZeneca / Pozen
`
`Collaboration and License Agreement
`
`August 1, 2006
`
`OMe4e
`
`For Cewrnen Fres
`
`ATTORNEY CONFIDENTIAL
`Page 1 of 105
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`PZ00002543
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`Patent OwnerEx. 2067
`Mylan v. Pozen
`IPR2017-01995
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`

`

`Execution Copy
`
`COLLABORATION AND LICENSE AGREEMENT
`
`by and between
`
`POZEN INC.
`
`and
`
`ASTRAZENECA AB
`
`August 1, 2006
`
`ATTORNEY CONFIDENTIAL
`Page 2 of 105
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`PZ00002544
`Patent Owner Ex. 2067
`Mylan v. Pozen
`IPR2017-01995
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`

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`TABLE OF CONTENTS
`
`Page
`
`1.
`
`2.
`
`DEFINITIONS 2oo..cccccccc cece cccccccccecceeeeeeeeeeseeceeesaeeeeueesesseceaneeeaeeeeseenecesneeseneeneeennneeengess
`
`l
`
`COLLABORATION GOVERNANCE... .cccccccceccccscscessensesesesesesessesseseasnecaseeseseneneneney 14
`
`2.1
`
` Establishment.......0.00.0..0.cccccccceeceeseeceseesensesceeeseesseaeseseeassacacesecseesssenscsaseaseessenasees 14
`
`2.2 Membership and Procedures. ...........ccceccseseeseseeseseteesvsceesseseesesesenevseseesesenenseasaeneees 15
`2.3) Decision-Making. .........0ccecccceececeeeesceceeceseseesceseeecsseccsecstessscceseaseasseassassaeaeceeeseaeaes 16
`
`3.
`
`PRODUCT DEVELOPMENT.......0..cccccccccccescceeeeeseesseeeeessseeeeesseeeeceneessseeseseseseseneenaees 18
`
`3.1 Development Plans, ............cccccecceceseeseceseseseescseseescseseeacsesacscsevecsesesseatsesssansavasereseas 19
`3.2 Core Development Activities. .........cccceccceeseccseseeeteeeesesesescseeeseeseerseerscneasersesetees 19
`3.3. Additional Development Activities. 00.0.0... ceeceteeeetetsescseeeeetsceerscseseescaesecateeneees 20
`3.4 Development of Products by AstraZeneca. ......0....0c. cece ceesceceeeeeeeceseeeesseeeeens 21
`3.5 Oversight of Proof of Concept Studies.........ccccccceeecesensesesenseseteeeeeetsseeeeneneeseney 23
`
`3.6
`
`Exchange of Know-How..u.........cccccccceccsceseseeseeeseseseeseeaeeecsecatscceeaseaveeeaetacereaeeersee 23
`
`3.7 Audits and Inspections. ..........cccccccccecceceeeseeeeeseseeeseseneeseseeseaeeececseeesecaesenetensesecsenes 23
`
`4,
`
`REGULATORY MATTERSoo... ccccecceceecseseseseseseseseseseeesesessaeseseseseneceesescsesescseenereneeees 24
`
`4.1
`
`Responsibilities; Diligence. ..........cccceccccsceccssessescscesseseeecscescesesecseesceeesecstseesceaees 24
`
`4.2 Access to FINS... ceescecseeescseseseseseseseseseseuansssesesssesenecenevessescacsesesenareatenaeeses 26
`
`4.3
`
`4.4
`
`Interactions with Regulatory Authorities. ...0.0.0.0.0...cccccccesesseeeessesesesescsescseetesseeeees 26
`
`Information Sharing... ccceeecsseseesessneceesesescsesesesscecseecseseseaeseseseetevavavacseseaees 27
`
`4.5 Regulatory Audits 00.0.0... cece cccccccceccesssesesscsesessescscsevetsssascscuaacseescaeseeavsceaeacscereases 28
`
`4.6 Adverse Event Reporting ...........cccccccescssescseeseesesceseseesacseestecesscatacsteatseeeateseeneas 28
`
`5S.
`
` COMMERCTALIZATION.....cccccccccececccsecessescecseseevssenesesesescsescsvevsaveveneatecavstsvavsuerseseeess 29
`
`S.L
`
`Commercialization 0... cecccessssssesssessescesssesceuesesesusseseevescscssscsesesseassvsneeeseseeseees 29
`
`5.2 Regulatory Obligations during Commercialization..............ccccccccceseceseseseseerseeeeees 29
`5.3
`Performance; Diligence. ............ccccccccccesecsesessesssessesessescsesscsescssseceveusrcaveveseavaveesavevs 29
`5.4 Commercialization Plan. ..........c..cccscccsessescsessesesssescsuesescsvsessesvssvavevsveavaeevavaveneeeees 30
`
`5.5
`
`Threatened Removal ..............ccccccccseessessessessessessesseevessssvsssesscassseeneesvsseansasaneavesveave 30
`
`COMPMANCE eee eeeeceeseesessecsessecsecscesensessecsessvesessvarsesssseaseessseeseeateaeereeavareaseareaveeees 30
`5.6
`5.7 Branding; Trademarks; Domain Names; Trade Dress; LOg0S............sc0scesse00000000-- 31
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`ATTORNEY CONFIDENTIAL
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`6.
`
`7.
`
`MANUFACTURE OF POZEN PRODUCTS.........ccccccscceseestseseetenstenenseerensenseeasecneneens 31
`6.1 Manufacturing Development...0...........ccccscecceseeeseeeeseseneeeseneeeseseeeenenenentineerseteeney 31
`6.2
`Process Transfer. ......c.ccccccccccscescesscscesecseesccssesecescesesaeeaececeecseseaesssesessseeaeeaeesesseeneeees 33
`6.3
`Terms for Clinical Supply... ccc ccececeseeseseseeseeceseeeseeesaeseseeassenseseaeeeeseneneneniens 34
`6.4 Commercial Supply ..........0.cccccceccceesesesesceeeeeseeeeseseseescsesacecseeassesasesesecessenenaeeeeensees 35
`6.5 Audits and Inspections. .......0....:ceccccesesseseeseeseeceesesenseecsceessssnesesssseeeseneassceenecseneets 35
`6.6 Reference Rights; Support 0.0.0.0... ccescesseseseeeseseeesssssseacsesssseecessesesanaeeseeaens 36
`
`LICENSES coi ccecccccccccccccecssesescscssesesesessescsevaeseseuecscseeeescsevecseseavscaevacsssecacaeevassaecsceseasacaeees 36
`7.1
`Licensed Technology ..........ccccceccceccsceseseseesesesesseseseeseseseeacscsecscaesevsesesseasseeasassaeaeaes 36
`7.2 Trademarks .0......c.cccccecccscescessesceseeseessessceeeseeseeceeaeesetsceaeeeaeesesarssesasasesererecseesaseeees 37
`
`7.3
`
`Sublicenses .........eccceccccceeccccseesesecsecseecesevsesecsesecseesececseeaesaeeecagesesessaesesaesetsseesesateas 37
`
`7.4 Reservation of Rights; No Implied Licenses .........0....ccccccceeccsecceseseeeeseseeeeseeeeeeenes 37
`
`7.5 Restrictive COVeMANE A... eecccccccesessesesesceeeseseceseneescseseeseaeeecseseeeesesenseateeescaneseaees 37
`
`7.6
`
`Japan Option... ccceccccccccsesesseesesessesecseceesessescsecsececseseneeseeseeaetesaeeaseeeaeeaterenenees 38
`
`8.
`
`FINANCIAL TERMS...00....c.cccccscscescscsssessssesesssacsessvassceesassesavssesaseceacsesavsesesesseseeacseeeees 38
`
`8.1L Upfront Fee. ccc ccccccccssecscesccsecsessecaessecsecsecsecsscsarcsecsecsseseesseeatsaesaecatensenaeeas 38
`
`8.2 Development Milestone Payment.............c.cccccccsccsessecssccscseceseeaseseesecsaeeeereeaesaeens 38
`
`8.3
`
`8.4
`
`8.5
`
`Sales Milestone Payment............0..0.ccccccccceecceseecsseesesscsescseessesesecseesteseseeseseeseeseeees 40
`
`ROVANIES. oe ee ee ceeecesccscscsecscscscescsesevssscsessvscseeevscsessvscstesssesesssacsavscsaacatiteavatseaeecs 40
`
`Payments and Sales Reporting. .............ccceccseseesseeseseseeeeseseeeeseseeseseseeecstesecsesesseees 43
`
`8.6 Records; Audit ......c.cccccccceeccccecceceeceeececessceececescecssecesecesscceaceceesegesaseessescseesseeseee 44
`
`8.7 TAKS. cceccccscessessecesesescscsesesesesesesecesavavsvasssssssssuessvavassvavavecatsenarsvavecavseavataneceavavevaess 44
`
`9.
`
`INTELLECTUALPROPERTY uo... .cecccecccccccsssescsessescseesescscescscsceccscscescacseeavatsacavscnavaees 45
`
`9.1
`
`9.2
`
`Prosecution and Maintenance of Licensed Patent.............0.0.cccccccceccscseseseeeseeeeveee 45
`
`Prosecution and Maintenance of Joint Patents ......0.0.0.0cccccccsssescesseceseseseseseeeseeeeeee 45
`
`9.3 Ownership of Inventions ........0...0.c.ccccccesccessesescsesesesesecscscssecstscstscsvasvevensesavecsvavavee 45
`
`JA—DiSCLOSUTC oo. eecccccscesessessesessssessesecseessssssssessssvsssesssessssssesavsesansavaueisenvareavereeveees 46
`
`QS
`
`COOPOrACION oa... ceecceesesesesesescsesesesvsucssscatsavsversseseatscavsvavsueereusueassvavssavavaveeeevenen 46
`
`Enforcement of Licensed Patents........0....cccccccccssssessssesessssesceresesesssseevsveresveresesveves 46
`9.6
`9.7 Defense of Infringement Claims .......0..0....0ccccccceeccescsssscesesesseseeseavessavcavaveavereevereeven 47
`9.8
`Patent Term Extension and Supplementary Protection Certificate ...............ccs0.0. 48
`9.9 Consequence ofPatent Challenge .............cccccccceccssssssssssesvssesscsessssveseeseseeveseesescesees 48
`
`-ii-
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`9.10 Patent Certifications. .........c.cccccccccccesccesseseeeeeeseeeesesesesesseseesscseessseeseersenevseeeenseneneees 48
`9.11 Patent Marking ...........cccccccccsesssseseesescsesessesesnssessssesssesscessnenescsnaneneanensanenensesenencenens 49
`
`10. REPRESENTATIONS, WARRANTIES; COVENANTS.........:cccccsssesescesesssseetsceeeeseees 49
`10.1 POZEN Representations and Warrantics............::csccccscsesceseeseseetsenetseneeeeseeneteeeey 49
`10.2 Notice of Development.............ccccesseeesesersesesessesesseseseaseneassseesesseserscnenseneenseseat® 52
`10.3 AstraZeneca Warranties ..............cccccceccesceseseeseeeesceseeeceseeeesceccsseseeecsecaeeseeeaseasieeeees 52
`
`10.4 Reciprocal Representations and Warranties ...........cccccccesccesesecssessseseseseseeeneseneneess 52
`10.5 DISCLAIMER OF WARRANTY........cccccccceceseseseeseeeeeseeeneesenenseseteesesceeeseaeeeeeeess 52
`
`10.6 POZEN Non-Compete ..........0cccccccccesccseeseeseeeeeseeceenseneceaeesersceeessasesecaseeecessaeaseaseas 52
`
`10.7 POZEN Subcontractors......0....ccccccecseeseseseseeseseesensenesseesesscereseecesssteeseeseeesseeseeess 53
`
`10.8 Other Nexium Communications........0.cccceeecceseeseseesceseeeeeeeeeeeaeesesseeeseeeceeesenenate 53
`
`10.9 Other Covenants..........c.cccccceccsccesseseeececseeecseseeseesceaeseeseeeessceeeeeerseeseeeeaeeeteesseeteees 53
`
`T1. CONFIDENTIALITY. 0.0... ccccccccecccsceescscseseanseseceescseseeseseeassessescseeecsesueeeseecseneeeerens 54
`
`PED Definition... ccc cccecccsesesecscsesecseseecatsesesescsesessesenecscsenscsesecseaesecseseeeeseaeeetseaeees 54
`
`L1.2 EXCLUSIONS... ce cccececccecseeseseesecsessesecscsecseseesecsesassecsecsesecsetaeseseesaseavaeeseeaeateaeerea 34
`
`11.3. Disclosure and Use Restriction ..........0.ccccccccesseseseeseeecsscseeecseesesseeeseeseeesseeseesateaes 54
`
`11.4 Authorized Disclosure .........cccceccccecscteesescessesesescsesecscsesesesessesesesseaesesavaeeneeseees 55
`
`L1.5 Use of Name oo. cccccccceccscsssscsesscescsesscserseesssecsssecsesseecsessescaesstsassasateassasseeseaaeass 56
`
`11.6 Press Releases......c.cccecccccccscscesesescesesesescescscseesesesesscsesesacscsevscsesscsesestacseeseetersssseess 56
`
`11.7 Terms of Agreement to be Maintained in Confidence ............c.cccccccceeesceeeeeeeeeeee 56
`
`12.
`
`TERM AND TERMINATION... cccccccccessscseesesesessesesesssacseeccsesesevsssceecacseeetstesaceceeeaeses 57
`
`12.1 HSR Act ecccccccecesesecscsestscsesescsesessscsesevavsvsvsvavssssssussavasacsvavavatacacetvavevevavavevarseas 57
`
`V2.2 Term voceeecccccccceccscseseeseeseseensesesetscsesessesesesaaessvessesesaseseseceeseaesecessesecscsesasscaceaseease 37
`
`12.3 Termination for Material Breach ................cccccccescscsesesscesessesesesssesesesececscstevavsesveves 57
`
`12.4 Termination for Cause. ..........cccccccscssscsesesesesescscscscsesesssvsvscscseacsceceusesseavsvevacaraneees 58
`
`12.5) Termimation at Wilk.......cccccccccccecccsecesccsesescsesesesescseecstsvavsvavavsvavenensasavevscevaevseene 62
`
`12.6 Consequences of Expiration and Termination...........c.cccccccccssessscseseeseeeeseeseseeseeseees 62
`12.7 Termination for Insolvency ............ccccccccccessescssesecsesesvessssevssesesvareaesvareacavaveneseaveeeses 66
`12.8 Effect of Bankruptey..........c.cccccccccccescsssessessessessessesressesressessestesessesavereeavareaseaseaseeees 66
`12.9 Post Termination Royalties .............cccccccsscssssessessssvssessescsueecsssseseateavsseaveseevesseveseese 67
`12.10 Formulation Technology...........cccccccccssessescsessesesssscsvsvesssseresesearessassaseavavsvesceveveneevs 67
`T2.VD Survival oo... ceecccsscessssesscsesseesscaresesreasssssvssssvesssseavsseavaseavesesecsveverseeitaseaveaveses 67
`
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`13.
`
`INDEMNIFICATION AND INSURANCE ........ccccceccceecesescsscecsereeseseseesssesenenseseseeenes 68
`
`13.1 Indemnification by POZEN .............ccccesecesesecesesesesesseenesversessscsesssseesevevesessaeaeaves 68
`13.2 Indemnification by AstraZemeca oo... eceeeeeeceseesesceesessteasesseasesscaeesesseesesseeneenes 68
`13.3 Indemnification Procedure. ...........c.ccccceeecseseeeeseeseeeeseeeeseeneesssecseesseaeetenesesssesteeeess 68
`
`13.4 EXpenses .......ccccccccccccsccsesseseesescesesecsseeesecseeseseesesecsecsecetaeaesaserseeeceeraeeesecaeereneseseees 70
`
`13.5 IMSUPAMCe...... eee cccecceseeseeseesecssesecsecsaeseessesseeaseaecaesaeeseeeacsessseeaseaeeaeeaeeneessenseneceaeeses 70
`
`14.
`
`LIMITATION OFLIABILITYoo... ccceccceseseesensesesseecsecseecseeeeecaetasseeaeneeseeanaes 70
`
`15. MISCELLANEOUS .......c.cccccccccccscscsceeescsseeesesesesesesescssesesesesesecseseecseeeeecsenenecsesenecseseeees 70
`
`IS. ASSIQMMet oo... ccc ce ccccseeseeeeeeseeeesecaeeeeseescseeseeecseceeeeecetaeeaseeeiseseeesaeeatseeeeeeates 70
`
`15.2. Termination of Certain Rights Upon POZEN Change of Corporate Control........ 71
`
`15.3 Severability... ccccccecccccccscsssseseseesesesessescssesssnsesevasesssvscsecavseeevacsesevavsceeeecscaeuees 7)
`
`15.4 Governing Law; Dispute Resolution. ...........0..cccccccceecesseseesesseseesesceseeeeseesesensasaees 72
`
`TS.5 NOtiCOS 2... ccecceccecscscsseeesssescsesescsssscuesscscuessssessusssceesasesscsssessaassceacsesesessetesvacseeees 73
`
`15.6 Entire Agreement; Modifications............0.cccccccccccssessescseeseesescescsseseesssseseesesevacsecsees 74
`
`15.7 Relationship of the Parties .........0..0....cccccccccesescescssesceseeceseseeetsceseeucsceseeecseesesesseees 75
`
`15.8 Waiver oo. ccccccccesesesesesesesesssesensvscscacsesescsesesesessessevsvscsssesescsssessavsvarsvasseateracavees 75
`
`15.9 Counnterparts..........ccccccccccccscsesecscscscsescsesescscsssecscsevavsssavsvacsusesessssvavensaveveneetacaesens 75
`
`15.10 No Benefit to Third Partics ........0.c.cccccesccscscssssscsesesescsecscsvscatscscscnensvscavevsvavaveveveces 75
`
`15.11 Further Assurance ........cccccccsscscsssssescsescsescsescscatssscecsesssaesvscscauscscucsevsvevscavavavevseavars 75
`
`15.12 No Drafting Party 2.0... cccceccesssesesesessceceescscsescsvsesescsesensvsvevsvssavavavscesaseceeeeessenens 75
`
`15.13 COMStructiOn. 2... cccccccsesssessessseseseseseeesesccnssssesescsescsesvsusscscsvarsvavsvesetevavavavevensesenas 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 — Initial ROW Development Plan
`
`Exhibit E—- ROW DevelopmentTimeline
`
`Exhibit F — TPP Studies
`
`Schedule 1.58 — Licensed Patents
`
`Schedule 4.1.2 - IMS MATData
`
`Schedule 6.1 — Initial POZEN Product Specifications
`
`Schedule 8.4.1 — Segregated Royalty Example
`
`Schedule 8.4.3 — Market Reduction Example
`
`Schedule 10.1 — Disclosure Schedule
`
`Schedule 10.7 — POZEN Subcontractors
`
`-V-
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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
`POZENINC.. a Delaware corporation havingoffices at 1414 Raleigh Road, Suite 400, Chapel
`Hill, North Carolina (“POZEN”), and ASTRAZENECAAB,a Swedish corporation having an
`office at SE-431 83, Mélndal, Sweden (“AstraZeneca”). POZEN and AstraZeneca each maybe
`referred to herein individually as a “Party,” or collectively as the “Parties.”
`
`RECITALS
`
`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-steroidalanti-inflammatory drugs.
`
`AstraZeneca desires to obtain a license to POZEN’sintellectual 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
`Cc.
`collaboration on the terms and conditionsset 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
`
`Whenusedin 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 Standardsas in effect from time to time (“IFRS”).
`
`1.1
`
`“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 andInitial ROW DevelopmentPlan.
`
`“Adverse Event” means any adverse medical occurrence in a patient or clinical
`13
`investigation subject that is administered a pharmaceutical product, as designated under 21 CFR
`
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`§ 312.32 and any other Applicable Lawin the Territory.
`
`“Affiliate” means a legal entity that, directly or indirectly, through one or more
`14
`intermediaries, controls,
`is controlled by, or is under common control with an entity.
`For
`purposes ofthis 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
`powerto direct the managementorpolicies 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,
`undersuchlocal law, be ownedbyforeign interests.
`
`“Applicable Law” meansthe laws, rules, and regulations, including anystatutes,
`15
`rules, regulations, guidelines, or other requirements that may be in effect from time to time and
`applyto the activities contemplated by this Agreementin the Territory.
`
`trade names, domain
`“AstraZeneca House Marks” means any trademarks,
`16
`names, or other names or marks used orregistered by AstraZenecaorits Affiliates at any time
`during the Term to identifyitself.
`
`“AstraZeneca Invention” means any Invention that is conceived solely by one
`1.7
`or more employees, agents, or independent contractors of AstraZenecaorits 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 U.S. DevelopmentPlan and first ROW DevelopmentPlan approved by
`the GPTpursuant to Section 3.1 (Development Plans), in each case consistent with the Initial
`U.S. DevelopmentPlan and Initial ROW Development Plan.
`
`“Business Combination” means any merger, consolidation, sale of stock, sale or
`1.10
`transfer ofall or substantially all of the assets, or other similar transaction to which POZENis a
`party, other
`than 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 transactionstill beneficially own, directly or indirectly, more
`than fifty percent (50%) of the voting power of the surviving entity immediately after such
`transaction.
`
`“Business Day” means anyday other than (i) Saturday or Sundayor(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
`112
`calendar months ending on March 31, June 30, September 30 and December31.
`
`-2-
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`“cGCP” means current goodclinical practices as defined in U.S. 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 U.S.
`
`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 ofbeneficial ownership ofJj
`of POZEN’s voting securities.
`
`“Clinical Trial Materials” means the Initial POZEN Product formulated in
`1.17
`accordance with the specifications of Schedule 6.1, matching placebo and matching individual
`ingredients and comparators, each packaged andlabeled for use in the applicable clinicaltrial.
`
`includes one or more
`that
`“Combination Product” means a Product
`1.18
`pharmaceutically active ingredients (in addition to a single Gastroprotective Agent and a single
`NSAID) andis sold in final form either in a single fixed combination oral solid dosage or as
`separate doses in a single package andpriced 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” meansall 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 developmentactivities 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 andactivities (e.g., dossier preparations andfilings) 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 meaningset forth in Section 5.4.1.
`
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`1.22
`12.6.4(b)(ii).
`
`“Commercialized POZEN Product” has the meaning set forth in Section
`
`to a particular Product being
`“Competing Product” means, with respect
`1.23
`Commercialized by AstraZeneca or anyofits 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 atleast
`
`“Controlled” means, with respect to any Know-How,Patent, or otherintellectual
`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
`agreementor other arrangements with any Third Party.
`
`“Core Development Activities” means anyactivities 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” meansall activities relating to pre-clinical and
`1.27
`clinical development of a Product andall developmentactivities 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, regulatoryaffairs.
`
`“Development Program” means the program of Development described in the
`1.28
`U.S. Development Plan and ROWDevelopmentPlan, 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 maybe, efforts
`and resources reasonably used by AstraZeneca or its Affiliates (giving due consideration to
`relevant industry standards) for AstraZeneca’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), 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
`lifecycle (assuming continuing development of such product), taking into consideration their
`safety,
`tolerability and efficacy,
`the profitability (taking into account any payments payable
`
`-4.
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`under this Agreement), the extent of market exclusivity, patent protection, cost to develop the
`product, promotable claims, and health economicclaims.
`
`“Direct Costs” means all amounts which POZEN disburses to vendors for
`1.30
`services rendered or product supplied in conducting studies pursuant to this Agreement. For
`clarification, no POZEN employee compensation, internally consumedsupplies, 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” meansthat certain pharmaceutical compound with the name (5-
`1.33
`methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole),
`
`including any
`
`
`1.34
`agency thereto.
`
`“FDA” means the United States Food and Drug Administration, or any successor
`
`“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 AstraZenecaor its Affiliate or Sublicenseefirst sells the Product
`intended for commercial distribution to any Third Party after 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 CommercialSale.
`
`1.37
`
`“Formulation Budget” has the meaningset forth in Section 6.1.4 (Expenses).
`
`“Formulation Development Activities”
`138
`Section 6.1.4 (Expenses).
`
`has
`
`the meaning set
`
`forth
`
`in
`
`“Formulation Technology” means any Know-How Controlled by AstraZeneca
`139
`in the AstraZeneca Inventions that are used by AstraZeneca in the manufacture, use, sale or
`import of the formulation of a Commercialized POZEN Product, and any Patents Controlled by
`AstraZeneca claiming such AstraZenecaInventions; provided, that Formulation Technologywill
`not include any Patents or Know-Howtothe extent directed to a Gastroprotective Agent, non-
`steroidal anti-inflammatory, or other drug or chemical agent, or any methods of manufacture or
`use thereof.
`
`the total number of
`“FTE Costs” means an amount equalto
`1.40
`onducting
`hours spent by POZEN development personnel
`Additional Development Activities for the Development ofInitial POZEN Products pursuant to
`
`multiplied by
`
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`this Agreementin 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 ofinjuryto 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 expertise in the areas of research & development,
`marketing, regulatory, intellectual property, finance, toxicology, and otherareas.
`
`1.43
`
`“GPT Chair”will have the meaningset forth in Section 2.2.1 (GPT) .
`
`“Group” means a group ofrelated persons or entities deemed a “person” for
`1.44.
`purposes ofSection 13(d) of the Securities Exchange Act of 1934, as amended.
`
`“IND” means an Investigational 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.
`DevelopmentPlan and Initial ROW DevelopmentPlan, 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 ROWDevelopmentPlan” meansthe outline for the ROW Development
`1.48
`Plan, as set forth in Exhibit D as of the Effective Date.
`
`“Initial ROW DevelopmentPlan Timeline” means the ROW DevelopmentPlan
`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
`1.51
`Timeline attached to this Agreement as Exhibit C as of the Effective Date.
`
`“Invention” means any invention, discovery or Know-Howthat is conceived
`1.52
`during the Term in the performance ofactivities 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 anyInvention that is conceived jointly by one or more
`1.53
`employees, agents, or independent contractors of AstraZenecaorits Affiliate(s) and one or more
`
`-6-
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`employees, agents, or independent contractors of POZENorits Affiliate(s).
`
`1.54
`
`“Joint Patent” meansa Patent claiming a Joint Invention.
`
`1.55
`
`“JSC” has the meaningsetforth in Section 2.1.2 (Joint Steering Committee).
`
`“Know-How” means any non-public, documented or otherwise recorded or
`1.56
`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.
`
`“Licensed Know-How” means any Know-Howthatis necessaryor useful for the
`1.57
`Development, Manufacture or Commercialization of Product in the Field of Use and that is
`Controlled by POZENoranyofits Affiliates as of the Effective Date or during the Term.
`
`“Licensed Patents” means: (a) the Patents set forth on Schedule 1.58, and any
`1.58
`substitutions, divisions, continuati