Cunfidemial
`
`AZELASTINE COMBINATIQN PRODUCT AGREEMENT
`
`This MELASTWE COMBINAWON FRODUCT AGREEMENT (“Aye-ramth is
`entered Inta $15 of the 1.3m day“ af Navembcr, 2066 (the “§fi§§tg‘ve Dag") by and between
`,MadPoimc maximum I'm“, a carpamtion organized, under the Iaws of Delaware with its
`principal place of business; a: 265 Davidsm Avmue, Suite 300,, Somersa’i, New Jamey 088?3«~
`412i) (“'MggPuintg” , and CIPLA M1,, a limited campany organized under the laws of India and
`having a piacc: of business at Mumbai Central, Mumbai 400 008, India (“W”) MedPoinw
`and Cipla are sametimes mfemd to individually as a “EM” and wllwtively as the: “m.”
`
`
`
`WHEREAS, Cipla is; m mime: 0f an misting Famulation (as hereinafter defined) and
`mlawd Pmduct‘lntcllccmal Pmpmty (as hminaficr dcfinfii};
`
`(as heminafier defined)
`to develop a Product
`WHEREAS, Cipla wislws
`cmnmmiaiimtim in the Territory {as hereinafter éefined) based on the Existing Formuiation;
`
`for
`
`WHEREAS, Medl’ointa wishes to exclusively Emma the Prnduct Intellectual Property
`(as haminaf’cer defined) for the Tarritmy m manufacm and have manufactumi the: Fraduct
`anywhere in the: world and market, 361%, import and distribute the Product in thc Te:me far the
`term 9f ibis Agreement and as pet that mama Inf thia Agreement;
`
`term of fihis
`WHEREAS, {lipia wishfis to grant MedPainte such a Hams: for the:
`Agreement for the Terfitm'y, as wan as a right of first refusai to acquire an exciusive iicense to
`market, 3831, import and fiistribute the Pmduct in certain Markats (as heminafier eiesfined); and
`
`WHEREAS, Cip'Ia wishes to my, and Madimainte wishas to pumhasa fimm Cipla
`aig‘hty parcent (MM) cf its mquimnema 9f the: Producst in the: Tcrritory.
`
`if: cansideratian of the rigms and abiigations 5c: farm In thi$
`NQW, TQEKEFORE,
`Agreement, and intending to be legafly baund, the: Parties agree 5m fnliows:
`
`ARTKILE I w DEFINITIflNS
`
`The faflnwing capimiizcd tmns shall have: Ihfi foIInwing mamings when used i2: this
`Agtmmem, and all tcrma definad in “the siflguiar ghall have the same meanfingfi when uscd fix the
`piuxai (and vice Irma, as appmpriam}, amass otherwise SpfiCIfiéd:
`
`M “Affifiata” mu mm with rassz to a “Fatty a cameraman, parmmhip, entity,
`person, trust, Iimiwd Iiability campany or other busimass entity that cantmIs, is centralied by, at
`is under cammtm warm; Wizh the mfarenced Party. Fa: the games of this definitian the ward
`“mun!” (inciuéing, with mueIative meaning, we teams “ on
`Head
`‘ or ‘ '3 1:21.63"f;
`tgge
`common comm] wig;") mcaus tile wasessiun, directly or indiwctiy, of the power in direct the
`mwagamem m palicics of the aypiicabie: emityi whether thmugh the owmrship of voting
`Swuritiag or by centraot relating ta voting rights or carporate govemanc: {)r atherwise,
`
`N‘N zmwmwmufimmmwmx .3362 3
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`1
`
`MEDA_APTX03490384
`C'F’2049
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`|PR2017-00807
`
`PTX1016-00001
`
`

`

`Caufidemial
`
`local or foraign
`“walkable Law” shall mean any applicable: fademl, slate,
`L2
`law, ordinance, rule at regulaliun, judicial order or industry stanm émposed by
`statute,
`regulation at law, including withaul; limitatlan the laws at“, and regulations promulgated under,
`the FDCAl
`
`“Galena” Year" anal! mean each successive twelve {12) manth period
`L3
`commencing an January 1 and ending cm DWI)“ 31; provifled that the first Calendar Year 0f
`this Agreemem: shall begin ml the Effwlive Date and and on Decmber 31, 20(15‘
`In flm want
`that the terminatian 01" this Agreement dues not, fall on the last day of a Calendar Year, the “film
`gajglmdg; film"” shall mean the: period Earn the first day 0f the memwrmm Calendar Year
`thmugh the applicable; date aflannination of this Agreement.
`
`1.4
`
`“ggmfiggw 43? mg“lags" shall have thc meaning set fourth in Section 63(0).
`
`the
`laws, guidalines and mgulations applicable to:
`“Will/lg” shall mean all
`L5
`manufacturing,
`lasting,
`labeliflg and packaging of the Preduct
`fincluding carmnt
`(30661
`Malmfamuring Practice regulatiana as gromalgawd ands: film applicable sections of 21 CPR
`(Chapmm Eli} and 23 l j}, as the: same may be amended at rmersacted from time In time.
`
`“figgfidential lnfamalion” shall mean the axistence: and contents afthis
`L6
`Agreement and any inflammation, in whalch film (and whether tangible or intangible),
`clisclosed by a Party (the “fliggklsing Party”) to the other Party (the “Resefiving Farlx” in
`eminectiun with that: discuagiens, pmfomanw or implementation of this Agreement ineluding,
`without limilatiom nompublic Intellectual Pmpefiy, any pending unpublishecl patent
`applicaticms, patent 0mm comspmdenm, new drug apglications and NQA submissions, FBA
`(31' other Regulatory Alumnrity mflcspandmm drug master fllcs, batch ‘mords, quality control
`rewards, technical 01‘ clinical data Trad-e Scarlets, know~how, mmch, product plans, products,
`services‘ supplim, mammal“ lists, prices and costs, softWare, develmpments, ideas, ‘lmhnlquea.
`business matlmds, phvwgrapha, aound rmrdingS, algorithm, invml‘ltms, labomlory notebooks,
`prowssw, formulas, technolagy, specificatéons, last mulls, dgsigns, drawings, engineering,
`mmketing, finances, hudgaels and other mutual 0r anlicipated Emsirlvzasé;6 rssaamh a: devalupmam
`imbmation whlch is disclosed by the: Uisclming Party :0 the Receiving Party and Wham: or not
`wwifiwlly clwigaaml as; mnfidemlal. Cam‘iawmial [affirmation small mé imlude:
`
`
`
`(a)
`
`infannation which a: {12:3 film of disclowm is; publicly known;
`
`infunnazian which, afler‘ the: iime of disciasure, bmamw publicly limwn,
`(i3)
`other than by bmach of an agreement between the Disclcsing Party anci the Receiving Party or any
`Third Farty;
`
`lnfamatim which is car was in the possession 0f the Receiving Early at the
`(c)
`time: af‘ dimlosure: by the Disclosing Party and was not acqulmd dimctly or indirectly from the
`fliwlusing Party or from any O’ther pally widest an obligatian of :confidentiality to the: Discluging
`Pamy; and
`
`infomation which is independently developad by at for rim Renaming, Patty
`(d)
`witlmsl réléimfieé t6 3r reliimce 11pm my Cunlidérltial lufoflna‘éion of {he flisclgsing I’m}! as
`demmmlraled by mdible written ducumenlalim.
`
`l‘l‘u’h l«EmilWEISWQyXNMkWCR‘ZMl 13m
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`2
`
`MEDA_APTX03490385
`
`PTX1016-00002
`
`

`

`Cenfidmiiai
`
`3.?
`
`1‘8
`
`“Hefauitin Part " shall have: the: meaning sei farm in Samoa 22.2.
`
`‘fb‘g'sgum" shall haw the meaning set farm in Section 16.6.
`
`“misting Formggtiog" shall mean Cipla’s existing (formulation, for the: nasal
`1.9
`away cambinaxzion pmduct containing azalastinc hydrochl‘mide and fluticasone pmpionate that is
`currently sold in Imiia under the “Duonasa” trademmk
`
`HO “EDA” snail mean, the {Juiwd States: Food and Drug Adminismtian, at any
`successm «misty mama.
`
`“EM” shall mean the: Fwdaral Fermi, 13mg &; Cosmatiw Act, 2} U.S,.C. 321 a!
`1.“
`my” any ammdmanw m“ supwmems macaw, or any wguiatians pmmulgated or adopted
`thereunder.
`
`1.12
`
`“Goa Facility” shall mean Ciplafiw, manufacturing facility in Goa, India,
`
`aft
`technolugy,
`“Imgmvegggnts” shat! mean, with resth to a particuf‘ar
`US
`tiiswvaries, inmvatiuns, impmvmmm enhancements, derivative: works or modifications; baseé
`upon such partigmiar technoiogy if and it) the extant mat the: legal righi ta maks, use, sail, cepy,
`diarime and perform such dismvm‘ias, innovations, improvements, mancemmxts, derivativa
`wcrks m“ madmcatiom wwld nacegsariiy rfiquim a license {Lew a Eicmse wnuki necessarily be
`required assuming that
`the impmver «af gush technology is my: 3130 the: owner 0? such
`tachmiagy) {a such particular mchnoiugy.
`
`LM “‘indamnitm” shall have: the meaning set {m} in Sectiun 14.3,
`
`1.15
`
`“imamgfgm I‘ shall haw: the meaning set fmth in Swim: 14.3.
`
`
`
`" shall man: (i) patents and applications therefor, inakuding
`“Intcflectual Pm
`1.16
`3:13 continuations, divisionais and cantinumions~in—pan thermaf and patents issuing max-eon, along
`with all missuw, recxaminaticms and extamions thereof (collectiveiy, "Patents”); (ii) trademarks,
`afiwiw marks, Wade names, sawica names. brand mamas, trade dram rights, iogas, mmorate
`names, trade? Siyleg, $0305 and other 5(3ch or businzzss icfentifim and general intarsgibms of a
`like nature, tngether wiih firm geodwiil associated with any 0f the: bragging, alang with a§i
`appfications, mgisn'atians, renewais and extensions the:me (wlleczively, ‘deemarks"}; (RE)
`copmghw whether a: not registm'esé or puinshed, an mgis‘trafiom ami meoréations {hereof and
`at; appfications in connectian therewith, 31mg with 31% reversions, extcmiam and remwals
`{hmle {callwfivalyg “Comigmg”); and (iv) conficimtfiai and prapriatary éismvm‘ies, cuneepts,
`idexas, research and dammpmmt, know~hom fomuiae, iraw'mimsa campagitions, manufacturiag
`and graduciien procmses and twhniques, technical}. data, procedures, dtssigns, drawings, batch
`and quality rewards, smcéficatiom, and. databasw (collectively, “7'1"
`215 was”).
`
`“Launch” shall mean, for main mommy within the: Territmya the first date when
`L17
`the Pmduct becames commerciafly available to consumers.
`
`L13
`
`“Emma” Sisal! ham 122:: mmfiflg gm fimh in 3mm 23
`
`NY 1 fl $333!!” \ZEZXVQ’SBXNQI 2‘ sacrum m I3
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`3
`
`MEDA_APTX03490386
`
`PTX1016-00003
`
`

`

`Canficiential
`
`Lit)
`
`‘fMarkm nggcg" ska}! have the meaning set Forth in Section 2.2
`
`“flagging: mammal Progeny” shall mean all Intellectual Pmpeflymiating to
`1.20?
`azelastina. alum andfmr in mmbinatinn with anther ingmdifinw, as sat forth an Schedule Bl for
`the Tmitoty, in each case: that MedP'ointe am or undm which Medl’ointe has the right 120 grant
`Iimnsm
`
`1.21 “mm” aha}! mean the grow amount invoiced to Third Paxtiesfcsr sale of the
`Pmduczt. in finished packaged farm, in tha Tmimxy, less, to the extent daductad from or on sth
`invoice: amnesiawm with gmamlly accepted acmmting pr’inciplm. consistently appiied, the
`following items: (i) quantity, mac 0: case discounts, chargaba’cks, Mums, ‘allowanwsg rebates
`(including Without limitatien any and all federal, state or local govemment rebates, such as
`Medimid mba’tea) and grime adjustmmts, to thenxtvmt actually ailawed; (ii) mics, customs‘ and
`other gxcisa tam and dutias or similar govmmwntal charges directiy reiatad to such sale, to the
`extant such items are included. in tha gross invaiw price; (iii) amounts aatualiy refundad due to
`m} acted! smiled, damaged, validated m" retumad Product; and (iv) freight, ghipmem and
`insurance mats, mafiain incurred Er: trampcming Produci' {a a Third Party purchaser anti
`mpamtfiiy invoiwd.
`in tin: cam 0f any mic uf Pméwzt Em censidamtion other than mammary
`cansidération, with as barter at countmrade, mush Profiuct shalt be {ime to be sow at £316
`average sales price éuring the appliaable repofling perfiod generatiy achieveé far such Product in
`the appiicahie muntry in {he Terrimry when such P‘mduct is sold affine and not with other
`pmducm
`
`
`
`L23 “NBA” shail meat: a New Drug Applicmion, matadng any mendmmts or supplflnents
`mama), in accordame: with the requiremmts afihe FDA
`
`L21
`
`“Nunwmef
`
`in ‘
`
`” shall have: the meaning set forth in Section 112.
`
`I .22
`
`“mice of 13mm: ” shalt have the meaniug set farm in Swim 112.
`
`“Pmdmt” ghaII mean a 2133a; away cambinaiion prodtmt mtaining azeiaatine
`1.23
`hydmahiofide (137 mcg} and fiuficasmm propionate (59 mag) which Wm ha: detwlopefi by Cipla
`fin" Madpwinm 33 par that mg a}? thig Agrmmt,
`
`“Product Inteliectual ngertx” Shall mean all} Enteflwtuai Property r6533:ng $0 the
`324
`Existing Fonnnlation and me: Pmductt as $61: fart]: an Schedgmgg, in each case that Cipla owns;
`or under which Cip‘ia has the: right: to gram iicenses.
`
`‘tfiaw Mateg‘ags” shaii mean amiastinc hydmchloride, fluticamne pmpianate and
`3.25
`all excipientfi, cammneats and 0mm: materiah; required E0 manufacture {he Product, excluding
`packaging labaiing and imam.
`
`feflmal,
`“Mammy Amharifies” shall, 'maain any applicable $upm-national,
`1.26
`natiunal,
`ragionai,
`state, pmvincial m Iacai
`reguEatery agencies, departments, bureaus,
`cammimiem, councils; 0: mm: gevemmem eniitiea,
`inclmiing without limixatian {he FDA,
`regulating or fithfirwise exercising authority with respect to the davekepmené and approval 9f“ the
`Pmducts in the Terrimry.
`
`I‘W i : vaféfifimll’flfi‘Ewfiatmkfilfiél mm
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`4
`
`MEDA_APTX03490387
`
`PTX1016-00004
`
`

`

`
`
`
`
`

`

`Cenfidentiai
`
`under firm abwe—mfamnwd agremenm shalI be exempt from the covenant set forth in subsection
`(b) but there wiil be m mixer pemitted exmptions during the Tm 9f thia Agmemmn The:
`parties. furthest am that Cipla daafi mt have any licsmse, covanant not to we or other authority
`from MudPoinw in cunneetion with the abovwafmnced figmemeuts and that this Agreement
`(1063 mt affect in any way any rights: Medl’ointe has or may have in the fith: to sue {lipia for
`patent
`infringmmt
`in mmwtion with any activitias relating ta ma abowreferenced
`agreements. Any subliwflms of MadPainte and its. Affiliates Rwanda: must agree to be bound
`by the terms and conditions of ma AMI?!“ as may apply In MadPainw. Madmin win be
`mammibfia far any Breath oommitmd by in: sublicwsm providmi Mechinte has: notice of web,
`breach and right to cure: pursuant: f0 Semen 12.2 herein.
`
`Righit 3f First ficfifiai. Cipla heretby grants MedPointe a right of first mfusm ta
`2.2
`enwr into an ax‘ciufiive lime With Cipla to’ market, salt, import and aimiwa a nasal spray
`mmbination pmducfi containing azalmstim hydrosfihlmida and fluticasme pmpiamte (the
`“Make: Piggggg") or the Product in the ntIuwing mummies: Gmmany, Spain, Portugal, film
`{5mm Kingdom, Italy, Franca, Japan, Kama and Austraiia (individualiy, 3 “gm” and
`collactiwiy, ihe “Markets”).
`Should MedPeinte desks to launch the Product or :he Market
`i’rodum' in am: of“ the Mamas, it will request that Cipia devgicp a Market Product for such
`Market at gram MWoinm the tights to the Pmduct for such Market, and such request shall mot
`be unmanably flamed mabjeei to a commercia! Agreemant to be: reached between Mechinte
`and Cipla an the said pragosai
`fihaulci flipla indepandenfly chem m munch the: Pmduct in the
`Mariam a: deveiop a Market Prodncs far we of the Markets, or agree :0 deveiap a Market
`Pmduct at MedPoime’s requesfi, it shali grant MedPoime the right of first mfusa! to market, 5e31,
`impart and distribute me: Pmduct cw the: kaet Preduct withm its wspective Market
`
`
`
`Ciplav shall, in its dimmimm aelect the Markets fur which it. deveiops a
`(a)
`Market: Premium; nmvidgg, howawr, Cipla shall in good faith take: Mcdminte’s mquests to
`dwelup Mark“ W:de fax partimlar Markets {m mnsidwation.
`
`Em]: fime Cigla dacifies; w iaunch ma Fmduct in a Market or deveiaps a
`(b)
`Markm Product far a Mariam, it shall firm appmach MedPointe in writing with an uffer t0 came:
`into an axclusiw: licensing arrangement {or that particuiar Market. MedPainte shalk provide; Cipla
`with a writtm wnfimatim 0f its interest within 32:11:14) weeka of Cipla’s written 01%;”. If
`Medl’ainm faiis t0 respond within four (4) weeks of Cipia’s written affer, it ska}: be deemmi a
`forfeiture at“ MedPainte’s rights wizh mspact 10 “that particular Market. The Ems and conditions
`(if the exciusiw: flames far {ha Mamas shali ha the subject (If separate written commercial}
`agreem exam betwmn the Partiaa; mind fifid, howeveg, that. Medi’oime agrees to mares (me hundraé
`pet‘ch (MIME) of its requirement of the Prodwt at the Maxim Pmduct for each reievam Market
`from Cipla, and that web agreements wifl inclmie provisions for alternate sourcing in ma event of
`a form majeure at what situation where Cipria is unable: t0 gupply Medi’ainta’$ (mire:
`requirememts»
`
`to the i’rodmzt er a
`If Madi’oinm dmlinw CipIaIs affer with respac‘;
`(a)
`paflicuIar Market Prcduct under Simian 2,203), but deiivers Cipla a written counter-offer within
`four (4) weeks a? Cipla’s affet, then CipIa 31:31? be free to solicit Third Party offers and enter ink:
`1mm 333%:sz miming m fin: mfium 61’ mt pmfifizuiar Mmkm E’waiuci 50 hang 2&3 fiat: mam
`
`NY! :2 immwmzwggawazmmmm 1.69%}
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`6
`
`MEDA_APTX03490389
`
`PTX1016-00006
`
`

`

`Canfidmfial
`
`finally agreed upon with the Third 93213: are commemially more favorable in the aggregale to
`Cipla than Mfidi’ointe’sl counterwoffen
`
`Exgress Rewafion of Righm. The Parties expressly mserve ail rights under their
`14
`mspealive Intellectual Pmparty that am 1101 expressly Iicenwd andfor granted to the 011361: i’my
`under this Agreement.
`
`Antiwfivarsim. Cipla shall amass cammarciafiy masonable affofis to maven“:
`2.5
`and/or stag: any diversion of Products made or sold by or fix Cipia. or any of its Affiliam into tlm
`Territory/I including via the intemet. Cipla shalt notin Mdeointe cf any divmsiml 0f Products
`made.
`{31* mm by m“ for Cipla or any of its Affiliates into tha Territmy,
`inaluding without
`limilation tracking down the swarm: 0? such divesrtad Products, discontinuing any cantractual at
`other ralatiomhip it or its Affiliate hag with such Third Party with respect to the diverted
`Pmducts, and keeping Medeime apprised of any such efferla~
`
`ARTICLE ill! a PAYMENTfi
`
`Ugfmnt Fee. MadI’ainte shall pay Cipla a Gma~time fee of seven hundmd and
`3.?
`filly ilzmszmd dollars ($750,000) upon exeeution Of this Agreement.
`
`Milestone Fee-‘3‘ MeniPoime shall pay Cipla the following onwtime fees within
`32
`thirty (30} days of the aehievement (1f the fallowing milestnne events:
`
`MILESTONE EVENT
`
`MILESTONE FEE
`
`the
`iramf‘er of
`Ciplaa’s
`tmhnalclgy m the {303 Facilfity
`flipla‘s manufacture: at" the l’hase: E climical hatches 9f US $398,006
`the Prwduct
`
`Praduei manufacturing US $396,036
`
`Medl’oim‘e’s Submissinn of an NBA for tlw Froduct in 1113 $150,000
`the Ur:in States
`
`g-g-ima’fi Egg gt“ McQPgng Dgfia. Medl’ointa hereby grants Cipla the right to use
`25$
`any clininal data relating; t0 the: Product thal is gall/waited by MedPulme during the: Term of this
`Agreement: 501er far cann‘trics outside the Tardmryk Cipla can use the clinical data in the
`Markets (as defined in Sectiml 2.2) pmvided MedPainte confirms within four weeks of Cipla’s
`written mth that MedPoime is not interested in daveiuping the Marth Product or Launching
`the Pruduct in the Markats. Cipla may amuse ta launch the Product in mummies outside thc
`Tammy and the: Markets, in which cam, Cipla may use MMPuinta’s clinical data subject in the:
`folIuwing condit‘inns :Cipla must antler into a separate? funna’l written agreement with Mail’s-mm
`matting forth the team". and condifians of usm (which waulci aovar any combination of amelmfine,
`and flutlcasorm) with such agrwmnt including a pmvision requiring Cipla to pay Mchointe a
`royalty cf“ tam pm“ch (10%) of any net sales of the I’roduct for the: first five (5) years of
`commercialization in each enmity outside the Territory“
`
`
`
`NY I 2: HIM55331432 lV'qngNOlIDOCWIfl-‘ILWB
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`7
`
`MEDA_APTX03490390
`
`PTX1016-00007
`
`

`

`Canfidemial
`
`Fa
`
`ants.
`
`pas; Balm. All payments- to be made undar this Amman! shall be made
`(a)
`in United States fiallara in imadiately available funda by wire transfar as designated by Cipla 01*
`by such other method \as‘ Cipla shall reasonably mtify MedPoime fmm firm to time“ Medi’ointe
`will endeavor ta make all paymcmts within 15 days‘of remaipt by Medl’nime of a valid invdiw
`from Cipl‘a but in any want shall «mum payments are made within 21 days of mwipl of such
`valid invalcc.
`
`lb) fiml MiedPainte shall also pay Cipla for all developmmt
`batches manufactured prior t0 tlw cmmemialimtim of film Prodmtl Cipla shall inwice at the:
`supply price atng hetwm the Parties far the Product lb! than batches.
`
`Interest. Clpla shall. charge: interest of 1% par 111mm far my late: payment
`(:2)
`‘
`whether it i$ related to development or comarclallmlon.
`
`ARTICLE IV a F‘QRMULATIGN DEVELGI’MENT
`
`Fonnulation Eevelogmemu Cipla shall be rasponsifile for zievaloping the Product
`4‘1
`far the Twimry based upcm the. Target Fannulation, which the: parties aczlmewladge may involve
`making passible medificatians, pmvided such modifimtlcns are agread upim price]:
`to
`lmplemenlatlm by Medpoinla. Cipla shall also manufacture all regulamry batchesl canduct
`stability testing and carry cut mamas valiéazian and analytical method validatiorzs reasonably
`mquired by Medialeime in canneciion with the rbgulatory approval pracess for the Product in film:
`Tazfiwry.
`
`MTIIL‘LE V w REGULATGRY MATTERS AND PATENT COOPERATION
`
`
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`MedPuinte shall be respansible fur“ (a) cunducting and
`5.1
`fimdifig all clinical sludies whelhar pilut a! pivotal studies which are required in (mm: t0 abmin
`wgulatory appmval m Launch the Product within the Territary, and (b) compiling and filing the
`NBA will} the FDA and analogaua agencies aumide the (LS. withln the: Territory Based on a
`mmmercial assexsmem of the market oppm‘tunititzs. Medl’ointe: shall
`in its sole éiscretion
`(lamina the aptimal timing and stramgy far making and obtaining regulath approval far the
`Product in the mummies within the: Tarritory. Cipla agrees to yroviéa Mfiéi’aime access in all
`data, analyses, (lacumematian or 0mm” assimance reasonalaly {mama :0 by Medl’ointe to
`wnduct ¢3inicai mam amt fila an NEE; a; othar applications for regulatory appmval with the
`appropmam Regulatory Authoritiea
`
`Ownarghig. MedPaime shall be the owner cf all data, amiyms and
`$2
`éucumemtafion it gmerates in its clinigal studieg relating to the: Pméuct during the Term of this
`Agreement, and shall salsa awn. all ragulatory filings and approvals, including mm, it submits
`within the: Territory.
`
`gymggjggggg Witt; the: Federal Fem Mg 8;. Casmexic Act. MedPainte warrants
`53
`that all Fmtiuct 80165 at promoted by it under this Agreement will. at the time of such sale 01"
`fiffirfiéfim, mi
`Ifié afiullemlefi (tiller lmmfér
`lhym $11333 to Mefilfiainéfi 0:“ while Willi”!
`Madl’oime’s central) or misbmnded within the meaning 0f the PGCA. Cipla warrants that all
`
`l‘f‘r’ l n} 4M3$fi7s02 “EQWNGEEBOCKGEM I 930%}
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`8
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`MEDA_APTX03490391
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`PTX1016-00008
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`

`

`Cmfidmtial
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`Product sold a: pmmoted by it under this Awemam win, at the time of such sale at promotim,
`mt be adulwrated (print to trmfer m MedPointc or while under Cipia’s central} or misbrandcd
`within the meaning of the FDCAI
`
`Exgamgg. MmdPoinw shall be wgponsibie, for all expenses associated with {fling
`5.4
`and obxaining regulatory approval of“ the i’roduct within the; Territory.‘
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`Elgaiityifixgreemant. The parties sigma that prim w commmiai male of the:
`5.5
`Product in the Territory may will enter mm a quality ammm submamially in the farm
`attachad harem as: fiy‘hibitfiéé.
`
`ARTICLE VI ~ PURCEIASE AND DELIVERY
`
`Gamma! Ghiigmion in Pimhase, During the Term and subject {a the {was and
`(LE
`wnditians of this Agremnem, Medi’oime shall. purchass eighty percent (80%) of its requirements
`if firm Pmfinm far mil? Tardth fmm Cipka, and Cipla shat} manufamum, ma, mil am! mm: m
`Medi’cium, eighty percent {80%) of Mefil’oime’s requirements of {he Product for the Tammry.
`
`6.2
`
`Purchase Wm am} Farmasts.
`
`Medi’ninte $1231} plane: Orders (“Purchase Orders”) spacifying time: quamity
`(a)
`(3f the Prisms}; it wishes m gurchasa and we}: ather commerciain reasonabie terms agreed upon
`by the Fatima. Cipla shall accept ali canfoming Purchase Orders submittad by Madl’einm
`pumumt hereto within five (5) days (if Cipia‘s receipt of such Puth Order. The tar-ms at“ this
`Agtaemant shall pmvai] over any inmaaistmt terms in any Purchase Order, acimowiedgment or
`invaice, Cipla small fill all confonning tham Onim within ten (10) days of receipt and wit!
`achieve a quarterly fifl rate ‘af' ninety pewent (99%), subject
`in the: {imitations otherwise:
`estabfished by Section 62k} hereof‘
`
`Patgm ghamatiom The partias agree that they small flatly cooperate: with one
`31.6
`wwther mi pmvide each other with all infomatian and assimilate mammary for the: pmswutimr
`of US. Fawnt Application: No. 16/313,016, filed June 13, 2303 (pubiished as U320060025391~
`M an February 2, 2M), any nominuaticn, divisional, continuatiominmpafl; reissue,
`reexménafion m interch £13m:on. and the patent appiicazions in Canada and Maxim that
`mmspond ti) and are the Cmaflim and Mexicm equivalems M such {13* patient applicatians
`(mileciiveiy 03de to hercin as “the Patent Agipiicatians"). Cipia shat! instruct its {Want
`comm! it: keep MedPninte fiiIIy infnmed mm substance, and status (if the prosecufion of the
`Patmt Applicmions and shall nhtain MecfPoime‘s commsnts and suggestivns prim” to taking any
`mated a! aciions in the prosecuiiun ofthe Patent Appiications. The parties also agree that Cipia
`midz'm' its wunsei wili take all actians in the: pmseemion of the Patent Appiicafiians {113% are:
`rcasanabiy recommended and/or requaswd by Med?0ime that would expand and/or maximize
`the snow {)5 the rights mught" pmvided if Cipia incurs my adciitiona! expense towarés this
`exercise Khan MedPnime win mimhume the same to Cipta.
`
`
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`1“in : «MGOfifiWJZWgflMELEQCWIMLOSE}
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`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`9
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`MEDA_APTX03490392
`
`PTX1016-00009
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`

`

`Cunfidwtial
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`Cipla shall pankage: and label the Fmdact with packaging and labeling
`(b)
`artwark appraved by Madl’ointé in the quantitifis and configuratians specified by Mchuinta and
`In conformity with CGMP‘ and industry practiczes;
`
`Cipla and MadPoime shall work together to minimize wam and maximize
`(in)
`smelf life {If this. Product by mardinafing graduation, invenwry maintenanw levels, Furchaw
`Calm and shipments as fallow:
`
`Frior' to tlw beginning elf each calendar quarter, (A) Madl’éintc:
`(i)
`shall provide: Cipla a furecaat {if its arders for the Product for the {allowing four (4) full
`calmdat quarters, and (E) Cipla shall pmvide: MedPointe with a tantafive mhédule for tha
`pmdwtion af‘hullc hashes OVEIT the same period, MedPoinw ahall pmvide Cipla with its
`first ‘fmecam and Purchase Quiet for the Product than: (3) full calendar munth(s) prior to
`the data:
`far first
`the mticipamd Launch within the Territory, as dammed by
`MedPainta.
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`'fha firm quaflm‘ly period in each four (flacalendaruquafier estimate
`(ii)
`provlded by MedPnime undar gectian 6‘2{c}{i) hercof‘ shall canstimte a binding
`Comminmmt to isxue Purchasa: Orders for the Proéuct (faring that quartet in an amount
`equal to aha forecast amount, and Medihinw shall issue conforming Purchase Orders
`{mm lime t0 time specifying quantities and delivery dates during such calendar quarter.
`Cipia shall use its cammmially reasanahle efforts is meet Medl’oinw’s mquestczd
`delivery dates, which shall be within ten (Ell) days afim‘ the: data Cipla memes each
`applicable seafarinng Purchase Carder. For avoidance of any almbt, if HM: P0 quantities
`are lass than the binding famast pmvided by Medpointe and (3191a: has completed
`manufamuring as per the “binding forecast, than Mechinke will pay far the: quantitiw
`:nanufacmed by Cipla as per the binding fumcastl
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`
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`Cipda shall not be requimd to swept Purchase Claim far quanti‘tlas
`(iii)
`af Product in amass of one hundmd and fifty pemem (150%) Mike amount speeified in
`the farecagt far the: relevant calendar quarter, but shall use aammemially masonalklc
`effcms to fill any relevant excess I’th Orderfs)" Med?ainte shall place Purchase
`Gféfii’fi in qzmmitias i272 immmmts equal In Clpla‘s minimum hawk size with the
`understamfing that Cipia will supply the: yield 0? the batch.
`
`{3.3
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`Qfilivem.
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`All salas shall be FOB Mumbai, India, and title and risk of less it: all
`(a)
`Pmclucts shall pass to MedPointe upcm tandflr to a qualified ataxia. Cipla shall 133:: MedPoima
`designated camera whenetvm“ possible.
`in that event that a MedPointe designatetl carrier is nut
`availabm, Cipla may mm a qualified carrier of its choice, with prim apprcsval fiam Madlmnm.
`
`Clpla shall furnish MedPninte a maificam of“ analysis (“Cem'ficgtg of
`(b)
`:Mlalxaia’fi far Weary batch pmdumgl with each slxipmem of firm Product, and a cap): of 615
`complete hatch record {including raw material, intermediate and final Proéuct testing ffiflitS) far
`the first ham}: of Prodact produoed afier the Efi‘eczive Date. At Med?0inte’s request, Cipla shall
`additionally provide a camplete batch record far all other batches 0f Fromm: prodaccd afict the
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`NY I :1Ialllallfiél'?QEXX’WXNQIE . WWI“ I. 00 I 3
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`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`1o
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`MEDA_APTX03490393
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`PTX1016-00010
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`Canfidemial
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`expressly corllraemally prohibited from using finch tmlmolmgy or kmwohow for any purpom
`lather than wpplying Pmduct to MedPolnte for the Ten'imry er the Markets as per the terms ol‘lhis
`figment, simuld, Cipla not be alum to supply them muntfies. Medl’ointe shall bear all mats in
`comedian with any Tech Transfar.
`
`PMgel $393135 FEES. Medl’einte shall pay Cipla a fixed prica‘per unit of $335
`6le
`far each unit of Pmth said by Cipla m MedPointe as eommemial mania pmduat. Mcdl’ainte
`shall pay ‘Cipla a fixed price peer unit of $2.00 far each unit 91’ Product: sold by Cipla to
`Melll’oime uwd all a phyalcian sampla These prices are an FOB, Mumbai basiap For avoidance:
`of“ daubt, these, prices :30 not imlude the cost of Azalasfine API which will be supplied by
`Medl’uime to Cipla as per the: mama ofthi‘a Agreement“
`
`;MumlllthQQ§gl MefiPolnte shall have: sale dimly!) over establishing (the
`6.”?
`prim al which it salla the: Praduct in Third Partiw in the Tarrimry.
`
`flaring the team 0? this agreement, Clpla shall use cummarcially
`Invmtmxl
`(“LS
`masonable cffarta to maim'ain a six (6) manila supply of Raw Matadals and comments :3th
`Azelamine. Medfainle will be magma: to (Ensure that Cipla has 6 months supply of Azelasiine
`in its invenlory.
`
`ARTICLE VII - MANUFACTURE AN!) QUALITY
`
`Manufacturing Cipla shall manufacture cammarcial batches of the Frodunt far
`721
`the “fenfimry at aha Gala Facility. Cipla shall maintain such facility in compliance with cGMP at
`ils mm 9031 and shall remain fully responsible far its workforce: and compliance with Applicable
`Laws‘
`
`
`
`Egmg'g)mmwM-Rfimmfi, Except for melamine: hydrochluride, Cipla shall
`‘12
`be snlaly maponsibla fur abtainlng all other Raw Matem‘alg and obtaining and maintaining all
`aquipmm‘i macaw far file: manufacture, packaging, testing, analysis and fihipmem 0f the
`Prodth censiswm with tlw ‘speeifications and Appllcable Law, including cGilvll’. During the
`Term 0? lhia Agreemml, Clpla shall nbtain its entira raquiremems of melasline, hydrachloricle for
`1m:
`in famulating and manuflmmring the Pmdum {mm Maxillainm, and Med9uintl: shall
`provide: at Medpainte‘s cost, Cipla with its entire requirements of azelasline hydrochloritle fur
`the Fmduat. meptly alter the Effective Date, Cipla shall pmvide Madl’ointe: Wm: samples of
`amlastine hydmahloride for which it has manufactured validation batches and prepared a drug
`master file: that is ready :0 be: filed, 56 13133 Medl’ointa may analyze such sample and damning:
`ils usability ax a Sta-mud source. At Mecll’oinw’s sole: discretiun it may shame to we azclastim
`hydrochlndde manufactuwcl by Cipla during the Term of the Agreemenll
`
`'m and i: elm * MmPalnla shall provide Cipla with all nmassaxy
`Pack
`“7.3
`packaging and labeling artwork for the Pmductl giving due canaldemtion to Medl’oinm’s
`fomwsw and Purchase Mam and Mad time: required by Ciyla to satisfy its obligations under
`such l’umi‘me Clrders, in a firmly manna. Natwithszanclmg anything herein to the contrary,
`Cipla shall not be respansible for any delay, breach or default hereunder resulting from
`Madl’ulme’s f‘aflure to fim’dsh Cipla with sufficient packaging and labeling earmark far the
`Product in a timely manner.
`
`NYI 1‘1 l4W§ONJEWQQXNQZLWC’WZMI .00“
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`12
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`MEDA_APTX03490395
`
`PTX1016-00012
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`Confificntial
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`Surviva . The folicwing pmvisions shall survive the tenninatian fifthifi Agreement for
`12.6
`any reason in accordance with their mspective terms: Article I, Vl'ii, EX, XEII, XW, XV, XVI
`and Sections 1 1.1, 12.3 12.4, 12.5 and 12.5‘
`
`ARTICLE XIII! w REPWSENTATIOIW AN!) WARRANTiES
`
`Cipla Rmmmtations and; Wmtiem. Cipia numb}; represents and wmmm to
`13.1
`MedPointe that:
`
`It has‘the comma newer, autlmrity and legal right
`I’awgr am! Authority.
`{a}
`In enter into thisfigwemmt and perfofln its obiigations hereunder and has taken aii necessary
`wmurate maxim cm its part requiwd ta aummfize the execution and delivery of this Agreement and
`the parfinnance (if its ohfigatitm’s hareundm.
`
`Bindigg Aggment. This Agreement has been «duly executed and tielivered
`(h)
`on behalf (SI/f Cipia and wastimms a Iagal, valid and binding obligation of Cipla that is enforceable
`against it in accardance wi