Confidential
`
`AZELASTI.NE COMBINATION>PRODUCTAGREEM:E.NT
`
`This. AZEtASTINE COMBINATION PRODUCT AGREEMENT • c•·A~eemet1tn} i~;
`entem<! . into as of the t3th. day of ~qyembet, .. 2006: .(the ''Ef(ective . Date'.·) p~ an4 befiVe~
`l\r1C(1Poi11t~ Healtbcare Ing~, . ~ corpQratiot) orgtmized under the .Jaws of Delaware with its
`principal place of business at 26.5 David.cwn. Avenue, Suite 300t Somerset~ New .lersey 08873"'
`4•120 •·t'MedPointe1')~ and .. CIPLA .. Ltd.,."··limit«J··company.otgall.ize4 urid,er••th¢ Jaws ·()flndia•;md
`)laying~ place ofhusin¢$S at Mumbaie~n~, Mumpai 400 oos> .. lridi~ (''Ci1}1a'');·.· ;M.edPointe
`and Ci.pla.are sometimes referred·to individually as a ~·Party'~and oollectivelyasthe HParties."
`
`WHiilWAS~ Cjpla i1rthe owner of' an Existing :F9..W~latiritl (as here:~na~~r •ciefi1led).afici
`relat¢ti.·•PtQduct•.Itstell¢etUal I'iOPetty·.(~s hetei,.,@ftetdefined);
`
`WHEREAS~ Cipla ·.·· wisf1es . to .. develop . a .. ·. Product (as . h~rt(jnafter . de~ne~). f()t
`C:ommercializ,ation in. the Territory {a$. hereinafter defined) based. on the. E~istin.g Formulation;
`
`WHEREAS, MedPointe wishes to exclusively license the Product Intellectual Property
`(as hereinafter defined) for the Territory to manufacture and have manufactured the Product
`an)'\vhere in the world and market, sell, import and distribute the Product in the Territory for the
`term of this Agreement and as per the terms of this Agreement;
`
`WHEREAS, Cipla wishes to grant MedPointe such a license for the tenn of this
`Agreement for the Territory1 as well as a right of first refusal to acquire an exclusive license to
`market, sen, import and distribute the Product in certain Markets (as hereinafter defined); and
`
`WHEREAS,_ Cipla wishes to supply, and MedPointe wishes to purchase from Cipla
`eighty percent (80%) ofi.ts requirements of the Product in the Territory.
`
`NOW, THEREFORE, in consideration of the rights and obligations set forth in this
`Agreement. and intending to be legally bound. the Parties agree as follows:
`
`ARTICLE 1- DEFINITIONS
`
`The following capitalized tenns shall have the following meanings when used in this
`Agreement, and all tenns defined in the singular shall have the same meanings when used in the
`plural (and vice vers~ as appropriate), unless otherwise specified:
`
`"Affiliate" shall mean with respect to a Party a corporation, partnership, entity>
`1.1
`person, trust. limited liability company or other business entity that controls, is controlled by. or
`is under common control with the referenced Party. For the purposes of this definition the word
`.. control'• (including. wi(b cQrrela~ive meaning, tile tenns "'controlled by .. or "is under the
`common control with") means the possession, directly or indirectly, of the power to direct the
`management or policies of the applicable entity~ whether through the ownership of voting
`securities or by contract relating to voting rights or corporate governance or otherwise.
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`PTX1016
`
`MEDA_APTX03490384
`
`PTX1 016-00001
`
`1
`
`CIP2049
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`CIPLA LTD. EXHIBIT 2028 PAGE 1
`
`

`

`Confidential
`
`applicable federal. state, local or foreign
`"Applicable Law" shall mean a
`l .2
`statute, law. ordinance, rule or regulation, j
`ial order or industry standard imposed by
`regulation or law, including without limitation the laws of, and regulations promulgated under,
`theFDCA.
`
`"Calendar Year·~ shall mean each successive twelve (12) month period
`L3
`commencing on January 1 and. ending on December 31; provided that the first Calendar Year of
`this Agreement shall begin on the Effective Date and end on December 3 L 2006. In the event
`that the termination ofthis Agreement does not fall on the .last day of a Calendar Yea:r, the "Final
`Calendar Year" shaH mean the period from the first day of the then-current Ca:Jendar Year
`through the applicable date oftennination of this Agreement.
`
`l A
`
`"££tlifi£1lte of Aua\y$iSH shall have the meaning set forth in Section 6J(c).
`
`15
`.. cGMPH shall mean all laws, guidelines and regulations applicable to the
`manufacturing, testing,
`labeling artd packaging of the Product including current Good
`Manufact
`Practice regulations as promulgated under the applicable sections of 21 CFR
`(Chapters 21 and 211 ), as the same may be amended or re-enacted from time to time.
`
`.. Confidential Information" shall mean the existence and contents of this
`L6
`Agreement and any information, in whatever form (and whether tangible or intangible),
`disclosed by a Party (the .. Disclosing Part)!") to the other Party (the .. Receiving Party") in
`connection with the discussions, performance or implementation of this Agreement including,
`without limitation, non-public Intellectual Property, any pending unpublished patent
`applications~ patent office correspondence~ new drug applications and NDA submissions, FDA
`or other Regulatory Authority correspondence, drug master fiJes .• batch records, quality control
`records, technical or clinical data, Trade Secrets, know-how, reseatch, product plans. products,
`services, suppliers, custorn.er lists, prices and costs, software, developments, ideas, techniques.
`business methods, photographs, sound recordings, algorithms, inventions, laboratory notebooks,
`processes, formulas, technology, specifications, test results, designs, drawings, engineering,
`marketing, finances1 budgets and other actual or anticipated business, research or development
`intbrmation which is disclosed by the Disclosing Party to the Receiving Party and whether or not
`~:>1J0Cifically d<.:Signated as conJidenUal. Confidential Infonnatkm shaU not include:
`
`(a)
`
`information which at the time of disclosure is publicly known;
`
`information which, after the time of disclosure, becomes publicly known,
`(b)
`other than by breach of an agreement between the Disclosing Party and the Receiving Party or any
`Third Party;
`
`· .... infonpatiot}whit?hisor w~jn tne possessi()l1 oft~e Rec~iving~I!J'tY atthe
`(9)
`time of' disclosure bytheJ)isclosing Party and was: not acquired directly or indirectly .. from the
`J)isclosing Party orJromany other party under an obligation of confidentiality to the Disclosing
`Party; and
`
`(d)
`
`information which is i
`to or reliance upon any
`wid!Qut
`demonstrated by credible written documentation.
`
`ndently developed by or for the Receiving Party
`dential Information of the Disclosing Party as
`
`2
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490385
`
`PTX1 016-00002
`
`2
`
`CIPLA LTD. EXHIBIT 2028 PAGE 2
`
`

`

`Confidential
`
`"Defaulting Party~· shall have the meaning set forth in Section 12.2.
`
`l , 8
`
`'"})ispute~·•.sh~.dl nave •. tbe ,·meaning, set,•forlh• in S®.tion 16.6.
`
`. ''Existing Formulation'' sball.tnean. Qjpla's . ~isting (orrn~d:tti?n, fqr th~ r1asal
`1.9 ...
`spray cornbinati()n.·.product·.contail).iqg· azel~tine··.·bydrocb{<)rid.e•,Md··•fluticasone pl"Qpiqnate tba,t.is
`currently sold in India underthe ''Duonase" trademark.
`
`~<FDAt sba.U mea.n the l1nited States Food and Orug Adminisgation, or any
`LlO
`syjjceS$Ot (>,rtt.itytheret()i
`
`l.lJ·· .... •·FilCA" sbaUmea~ .the . FederaLFood, . Drug & Cosmetics Act). 2llJ.S.c .. 32l .et
`s~m ~ aqy am~n<1me11ts; or'. ~ur>Plem~pt,s th~eto, or> any regulations promtJlgated or adopte<i
`thereunder.
`
`Ll2
`
`'*Goa Facility~ shall mean CipJa•s manufacturing facility in Goa, India.
`
`"Improvements" shan mean. with respect to a particular technology, an
`l .13
`discoveries, innovations, improvements, enhancements, derivative works or modifications based
`upon such particular technology if and to the extent that the legal right to make, use, sell, copy.
`distribute and perform such discoveries, innovations, improvements, enhancements, derivative
`works or modifications would necessarily require a Hcense (i.e .• a license would necessarily be
`required assuming that the improver of such technology is not also the owner of such
`technology) to such particular technology.
`
`1.14
`
`"indemnitee" shall have the meaning set forth in Section 14.3.
`
`1.1 S
`
`''indemnitor" shall have the meaning s.et forth in Section 14.3 •.
`
`'"Intellectual Properti> shall mean: (i) patents and applications therefor, including
`1.16
`all continuations, divisiona1s and continuations-in-part thereof and patents issuing thereon, along
`with all reissues, reexaminations and extensions thereof(collectively, .. Patents"); (ii) trademarks,
`service marks, trade names, service names. brand names. trade dress rights, logos. corporate
`names. trade styles, logos and other source or business identifiers and general intangibles of a
`like nature, together with the goodwill associated with any of the foregoing, along with all
`applications, registrations, renewals and extensions thereof (collectively, .. Trademarks"); (iii)
`copyrights whether or not registered or published, all registrations and recordations thereof and
`aU applications in connection therewith, along with all reversions, extensions and renewals
`thereof (collectively. "Copyrights .. ); and (iv) confidential and proprietary discoveries, concepts,
`ideas, research and development, know-how, formulae, inventions, compositions. manufacturing
`and
`·
`processes and techniques, technical data, procedures, designs, drawings, batch
`and uality recordsJ specifications, and databases (collectively, "Trade Secrets').
`
`"Launch" shall mean, for each country Within the Territory, the first date when
`1 .17
`the Product becomes commercially available to consumers.
`
`3
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490386
`
`PTX1 016-00003
`
`3
`
`CIPLA LTD. EXHIBIT 2028 PAGE 3
`
`

`

`Confidential
`
`t.•19
`
`"Market Product''<shaU have the meaning set forth in Section 2.2
`
`l .. 20' . ·.·. ·~MedPointe lfitellectuat Property'~ shall mean all lntellectuaLPropertyrelating to
`azelastine, alou~ ~dlor ht ~ombination with other.in~redients, as .•. setfotth on Schedule Bl .•. for
`theT~l'litqry. itt eaclt cMe th~tMedPoipte oV/nl) or l,lllderwni~4 M<XiPoint~ ·h~s ~be .pght to·.gran(
`licenses.
`
`'•'Net• Sates'' shall•mean< the.··gross•.WQount •. invoiced •. t~:>Third Parties·••fqr sale .ofthe
`l .21
`Product, in finished packaged fqrm, in the T~itory~ less~to the extent deduct~<l ft()tn or ()n such
`i~wojce ·.consis~ent· wlth.•.generallyaccepted.ace<>untingprinciples, consistently .. applied,. the
`folloWif1s••itel1l~: •. (i)••quan~ity,. trade<>r•·c~e (jiscounts~···~hargeka~ks, .• returnst • allowance~, . rebat~s
`(jncludingwithout.limitationany and all fooetal,.state or·local govemmentrebates, such as
`rvle<Jjc~i<l •.. re9ates) •. an<l price .adjue;tment~·· to the ~tent act~lly.·allow<Xi; •·(ii)• sale~. ·c~stoms, 'and
`other excisetax:es. and duties or sin)ilar gov~ental cl1atges (lire<:tlyrel~~~ to SlJ.Ch sale~ totne
`extent such•·.itcrns are•inc.Iuded in tbegrossinvoice price; {iii) amountsactuallyrefunde<fdue•to
`rcJe¢te(l, S.pdiled, damaged, outdated ol'retu.rned Pr9dl!ct; and .(iv) freight, spipment~d
`insurance costs actually incurred in. transporting Product to a Third Patty purchaser and
`separately invoiced ... In the case of any sale ofProductfor consideration other than monetary
`consideration~ such as batter or countertl'ade. such Proouct shall be deemed to be sold atthe
`average sales • price during the .applicable reporting period generally achieved for such Product in
`the applicable country in the Tenjt()ry when such. Product is s()ld alone and not with other
`products.
`
`1.22 "NDA" shall mean a New Drug Application, including any amendments or supplements
`thereto, in accordance with the requirements of the FDA.
`
`1.21
`
`.. Non~Defaulting Patty" shaH have the meaning set forth in Section 12.2.
`
`1.22
`
`"'Notice ofBreacih'' shall have the meaning set forth in Section 12.2.
`
`"Product .. shall mean a nasal spray combination product containing azelastine
`1.23
`hydrochloride (137 meg) and fluticasone propionate (50 meg) which will be developed by Cipla
`fi>r MedPointe as per the terms of this Agreement.
`
`"Product lntellectual Property" shall mean all Intellectual Property relating to the
`1.24
`Existing Fonnulation and the Product, as set forth on Schedule B2, in each case that Cipla owns
`or under which Cipla has the right to grant licenses.
`
`"Raw Materials" shaH mean azelastinc hydrochloride, fluticasone propionate and
`1.25
`aU excipients. components and other materials required to manufacture the Product, excluding
`packaging. labeling and inserts.
`
`.. Regulatory Authorities" shall mean any applicable supra-national. federal,
`1.26
`national, regional, state} provincial or local regulatory agencies, departments. bureaus,
`ns, councils or other government entities, including without limitation the FDA,
`or otherwise exercising authority with respect to the development and approval ofthe
`Products in the Territory.
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490387
`
`PTX1 016-00004
`
`4
`
`CIPLA LTD. EXHIBIT 2028 PAGE 4
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`

`

`Confidential
`
`"Target Formulation" shall be the nasal spray combination product containing
`1.27
`azelastine.bydrochloride and fluticasone pmpionate that .. shall.serve .as the basis for the
`fonnulation •develQPWertt.work•ty·. be •. eondu~tcdpu~uant. to · this.·.,A.gr~emen,t as•·setforth.in
`Schedule A at~cbedhereto and made a part hereof.
`
`l :28 ...... "[e¢h Transfer' sballmpan epoperation b¢tweenthe Cipla and MedPointein
`effccting ·an otdedytransiticm.··pfmanufac;,gritl&·m~tt~s.with .• resp®tt() ·tn¢. Produ~h· including
`tr:ansfemng •• copies o.freasonably· necessa~ . information· and ·filesrdiscl~sing .all .. reasonably
`nec~$~r'Y Product In~lleetual Pr:Q~~Y and granti~ all ne~~$arYright$ oirefe~nce with
`respect .. ·.to·the FDA .ot other· applieabJe•Regulataty•A\lth()rity to··MC4P()inte t~vvaJ'd~ qualifYing
`either•. MedPointeor ·a·•• se<:ondar)l .S\lPJ?lierto:.sUJJplytwentypercent•(20%).of.Me<fPointe~s
`commercial tequiretneJ:It ortQ supply the ProdiJ.Cld\JJit1S force pt~J~u.re conditi~ns~ . To th~ ~xJet~t
`f\pplicablt~·Law.·re:quires •Medl>ointe ·to ... eontrol .• originaldocuments~ •·suchoriginal.··documents·will
`be·••·pt6vi.de.d• t<> •Me<JPpint~····~s.••P.:(trt·•<>f•th~ .•• Tfl¢ll .. l"t@.sfer.
`
`l.29
`
`"1'ertrW shatlhave the meaning set forth in Section 12.1,
`
`1.30
`"Territory" shall mean the United States of America and its territories and
`possessionsJ Canada and Mexico.
`
`"Third Party" shall mean any person or entity other than Cipla or MedPointe~ or
`1.3 I
`an Affiliate of either ofthem.
`
`ARTICLE II- GRANT OF RIGHTS
`
`Grant. Subject to the terms and conditions of this Agreement, Cipla hereby grants
`2.1
`MedPointe an exclusive .license1 with the right to sublicense, tmdet the Product Intellectual
`Property to use, have used. market, seU, import and distribute the Product in the Territory for the
`tenn of this Agreement and a non-e:l(clusive license, with the right to sublicense, to manufacture
`and have manufactured the Product anywhere in the world towards manufacturing twenty
`percent (20%) of the Temrories requirement. This license shall also include the right of
`other data relating to the Product for the Term of
`MedPointe to use all of Cipla's s
`.for the Tam of this Agreement, (a) neither Cipla
`this ,\&!reement For the avoidance of
`nor any of its agents. licensees or Third Party distributors shall be permitted to market~ sell>
`import or distribute the Product or any other combination azelastine hydrQChloride and
`fluticasone propionate nasal spray product in or intO the Terrirory other than through MedPointe;
`and (b) Cipla agrees not to infiinge any MedPointe Intellectual Property anywhere in the
`Territory by manufacturing, having manufactured, using, selling, offering for sale, importing or
`exporting any goods or services; provided MedPointe infonns Cipla of its existing MedPointe
`Intellectual Property.. Schedule B 1 attached hereto shall serve as notice to Cipla of MedPointe
`Intellectual Property within the Territory, as of the Effeetive Date and MedPoin.te agrees that it
`shall update Schedule B 1 from time to time to reflect any changes to MedPointe futeUectual
`Property. Notwithstanding the foregoing. CipJa has notified MedPointe that it has two existing
`contracts with unidentified parties. one contract for supply of a finished azelastine hydrochloride
`product in Canada. and the other contract for supply of a finished azelastine hydrochloride
`rn·t:Jtlw;:t in the U.S. and Canada. the existence of which may viC~latc the covenant in su.'b>cction
`(b) by Cipla. The parties agre~ that actions taken by Cipl~ solely to carry out its obligations
`
`5
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490388
`
`PTX1 016-00005
`
`5
`
`CIPLA LTD. EXHIBIT 2028 PAGE 5
`
`

`

`Confidential
`
`under the above-referenced agreements shaH be exempt from the covenant set forth in subsection
`(b) but . there .. win be liD . other pennitted. exceptions. during the .· Tenn of this A,greement Th~
`patti~(\ltthera~ tn.atCipla goes not ha.ve . anylicense~ covemmt nqt to sue ?r•otherautbority
`from. MedPointe·• in .. eonnectiott ·Witb the above--referenced agreements .and that this Agreement
`doeli not ~,tffect in any way. any rights MedPointe ·na.s or may ·have in the future (o $u~tCipla. for
`patent btfring¢tn¢rtt. in . ~pnp~ction .. ·. witlt .. • anY . actWi~~~ ... r~Iating tp • the ... abov~teferertce<l
`a~reements. An.Y sublicensees ofMedPointe and its Affiliates hez:~mm:ler must a~e to be bound
`by .thetenn~ and. ®nd.itions. of this Agre<mlent •. a$ Utey apply toMed.Pointe. Medl'ointe will. be
`tespt>nsi.l:)te for •any brea¢h C9tnrnitte(J .. l:)y··its•· sublio¢llsee$• provided.l\1edPointc: •!las. J}()dce .qf·sucv
`breach and .tight to cure pursuantto Section 1 :.Z-2 herein.
`
`Right of FirSt Refusal. Cip\abereby grarit$ Xvie(}Pointe a dglltoffjrsfrefusal to
`2:2
`entet. into ~·. ex~lu$t'V¢ lic~se with Cipla to rnar:ket).:sell, import apd distribute a nasal $pr(1Y
`combination product containing azelast.im~ hydrochl<>ride and fluticasone · propionate ·•(the
`"Market. Product'') or tl;te Pro<il!Ct in the following . countries: GeftnanY~ Spain .• Portuga)~. tl;te
`United Kingdom, Italy, France, Japan, Korea and Australia (individually, a «Market" and
`collectively, the "Markets''). Should MedPointe desire to launch the Product or the Market
`Product in one of the Markets, it will request that Cipla develop a Market Product for such
`Market or grant MedPointe the rights to the Product for such Market, and such request shall not
`be unreasonably denied subject to a commercial Agreement to be reached between MedPointe
`and Cipla on the said proposal Should Cipla independently choose to launch the Product in the
`Market or develop a Market Product for one of the Markets, or agree to develop a Market
`Product at MedPointe's request, it snaU grant MedPointe the right of first refusal to market, sell,
`import and distribute the .Product or the Market Product within its respective Market.
`
`Cipla sb11ll; in Jt~ discretion~ sele¢t(he. Market!$ for which.itdevelops .a
`(a)
`Market PJ'p(}utt; provided, however, Clipl~l $hall ln gqqd. Jaitli ··®c~ Me®oii)te~l) r~Q¢!>t~ to
`dev~lop. M.arket.Ptoducts·for•particul.ar·Matkets••into•consideration.
`
`Each time Cipla decides to 1aunch the Product in a Market or develops a
`(b)
`Market Product for a Market, it shall first approach MedPointe in writing with an offer to enter
`into an exclusive licensing arrangement for that particular Market. MedPointe shall provide Cipla
`with a written confinnation of its interest within four (4) weeks ofCipla's written offer. If
`MedPointe fails to respond within four (4) weeks ofCipla's written offer, it shall be deemed a
`forfeiture ofMedPointe's rights with respect to that particular Market The terms and conditions
`of the exclusive licenses for the Markets shall be the subject of separate written commercial
`agreements between the Parties; provided, however, that Med.Pointe agrees to source one hundred
`percent ( 1 00%) ofits requirement of the Product or the Market Product for each relevant Market
`from Cipta, and that such agreements will include provisions for alternate sourcing in the event of
`a force majeure or other situation where Cipla is unable to supply MedPointe's entire
`requirements.
`
`lf MedPointe declines Cipla;s offer with respect to the Product or a
`(c)
`particu1ar Market Product under Section 2.2(b); but delivers Cipla a written counter-offer within
`four (4) weeks ofCipla's offer. then Cipla shall be free to solicit Third Party offers and enter into
`to tho Product or thnt purti(~Uh:rr Murke:t froduct so km~ ru~ the terms
`
`6
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490389
`
`PTX1 016-00006
`
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`
`CIPLA LTD. EXHIBIT 2028 PAGE 6
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`

`Confidential
`
`finally ~gr~d . upon. with. the Tbird .. Patty are commercjaUy more favorable in the. aggregate to
`cwna than Mq;dPqj:n.te's (?0Ul'Jt~-t>ff¢r,
`2.3 .... · Cipla~sJJse oflvf'ed)>oittte DiMa, .·· MedPoitite hereby ~nts Cipla. the ry~tto . use
`:m,y clinical ctata telatin~ to ·. tlte Product tliat is gener~e<l by M~Pointe d.urins the Term t>f th.is
`1\;greement solely for countries outside the 'J'enitocy. Cipla can use the clinica'l data in the
`Markets:···(as ... defined •. in .. S®tion ... 2.2)· Pl"()vided .. MedPointe .connnns ·within .• · .• :four •.• -weeks .• ·Qf.~iplat s
`written noti~e tbat • .. Me<lPointe··•:·is .. n()t• .. i~terested in••.d~:>velqpil')g ••flle · Market•.•Pr()du.;;t .. or Lau.nching
`the Product in the Markets. .Cipla may choose. to launch the Product in .countries outside xthe
`'ferrltocy an<i tli(} Market$, in 'vhich c~e, .• Cipl~ .may • u~e Me<iPoiJ}~e~s cliri.i¢31 t~ata ~~bjc::¢t to the
`following con.diticnls. :Cipla Jl1~t .ent~rinto a ~eparatefo~afWritten a~eementwith MedPointe
`s~ttiltg Jort:h. th~ tt~nnsand condit:ipns of .us.e(whichwol.lld. qover any 9();mbinaijqn pf ~elastine
`and fluticasone) wi~ st1ch a~reement including a prpvision req~irittg Cip!a t<l pay McdPointe ~
`royalty .of ten percent·. (lO%) of any net sales of ·the Product for the first five (5) yean~ of
`CC>mmerci~lir.Utjonil1 ~b. country •• outside· tpe ·Teftit<>ry.,
`
`Express Reservation ofRigbts. The Parties expressly reserve aU rights under their
`respective Intellectual Property thatare.not expressly licensed andlot granted tothe·ofuer PartY
`under this Agreement.
`
`Anti-diversion. Cipla shaH exercise commercially reasonable efforts to prevent
`and/or stop any diversion of Products made or sold by or for Cipla or any of its Affiliates into the
`Territory, including via the internet. Cipla shall notify MedPointe of any diversion of Products
`made or sold by or for Cipla or any of its Affiliates into the Territory, including without
`limitation tracking down the source of such diverted Products, discontinuing any contractual or
`other relationship it or its Affiliate has with such Third Party with respect to the diverted
`Products, and keeping MedPointe apprised of any such efforts.
`
`ARTlCL}1:UI·• J>AYMENTS
`
`fifty thousand
`
`. MedPointe shall pay Cipla a one-time fee of seven hundred and
`($750,000) upon execution of this Agreement.
`
`Milestone Fees, MedPointe shall pay Cipla the following one-time fees within
`thirty (30) days of the achievement of the following milestone events:
`
`MILESTONE EVENT
`
`MILESTONE FEE
`
`transfer of
`the Product manufacturing US $300,000
`Cipla's
`technology to the Goa Faci1ity
`Cipla's manufacture of the Phase I clinical batches of US $300,000
`the Product
`MedPointe's submissi.on of an NDA for the Product in US $150,000
`the United States
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490390
`
`PTX1 016-00007
`
`7
`
`CIPLA LTD. EXHIBIT 2028 PAGE 7
`
`

`

`Confidential
`
`Pay;ments.
`(aJ
`U.S; Do1lars •. .. All payments to htlll'Ulde qnderthis A.~enteritshall be.made
`i.n United ·~tate$ Dollar$ in i~(!diatelyav'*ilable full(is by Wire ·trafist'er as design~ted brCipla ot
`by such other method as Cipla shall reasonably notiry Me<.tPointeJrom time ro time. MedPointe
`will endeavor to m~e all paymen*s within .··t;S . <lays of.~:eceipt by .M.ed:P()~nte of a valiij i-r1voice
`from C-pla bQt jn ~y el)'etif ~lj~ll en$"(e paym.~nts ~e t'Jtad~ Wit}tin :ll days ofreceipt of such
`valid·in.voice,
`
`Development Batches,. MedPointe ~haU also pay C•pJaJ()r aU 4eV¢lopro~nt
`(b)
`!J~tc;hes rnarttlfa.~ttll'ed prior to th~ comJl1¢J;cializ~t,J()J1 of the Pf()duct. Cipla shall invoice atthe
`supply price agreecl between the Parties for the··Productforthese batches~
`Interest! Cipla shall charge iriteresfofl% p~t trton.tll for • any lateJ,~mt.rrtt
`(c)
`whetherit is related todevelopmentor con:unercialization.
`
`ARTICLE IV- FORMULATION DEVELOPMENT
`
`Formulation Development Cipla shall be responsible for developing the Product
`4.1
`f-or the Territory based upon the Target Formulation, which the parties acknowledge may involve
`making possible modifications~ provided such modifications are agreed upon prior to
`implementation by MedPointe. Cipla shall also manufacture all regulatory batches, conduct
`stability testing and carry out process validation and analytical method validations reasonably
`required by MedPointe in connection with the regulatory approval process for the Product in the
`Territory.
`
`AR'tiCLE•·V·- •REGULATORY·MATTERS AND·•PATEm COOPERATION
`
`5.1
`Regulatory Filings. MedPointe shall be re~ons)ble for (a) conducting and
`funding aU clinical studies whether pilot or pivotal studies which are required in order to obtain
`regulatory approval to Launch the Product within the Territory, and (b) compiling and filing the
`NDA with the FDA and analogous agencies outside the U.S. within the Territory Based on a
`commercial assessment of the market opportunities, MedPointe shall in its sole discretion
`determine the optimal timing and strategy for seeking and obtaining regulatory approval for the
`Product in the countries within the Territory. Cipla agrees to provide MedPointe access to aU
`data, analyses, documentation or other assistance reasonably required to by MedPointe to
`conduct clinical studies and file an NDA or other applications for regulatory approval with the
`appropriate Regulatory Authorities.
`
`all data, analyses and
`Ownership. MedPointe shall be the owner
`documentation it generates in its clinical studies relating to the Product during the Term of this
`Agreemen(, and shall also own. all regulatbry filings and approvals, including NDAs, it submits
`within the Territory.
`·
`
`MedPointe warrants
`time of such sale or
`while under
`Cipla warrants that aU
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490391
`
`PTX1 016-00008
`
`8
`
`CIPLA LTD. EXHIBIT 2028 PAGE 8
`
`

`

`Confidential
`
`Product sold or promot~<i .by it under@~ Agreement will,. at thetimeofsucb sale or promotion,
`not be adulterated (prior to transfer to MedPointe or while under Cipla's control) ormisbnmd.ed
`witbin.themelVting•.oftheFDC:A.
`
`5.4
`Expenses.. Med.Phirit-e sb~U be respOilsible.fot all ·cx.pel)se~ assriciateQ With fiJing
`iltl4••·()bt#ir1i.~g.·r~guJa~qty·
`·approv-al••.or·the •Pr()d1l(lt•••\vithi~· tf'1~Te:g:itory.
`
`5.5 QualityAgreemeut The parties agree that prior to comm~-:rdal $~le of the
`J?r()d~et jn Jl1e !erriJ()rjr theY ·Will. etttef intp a. CJU(llity .. agre~ent $l!P~M~i~llyitJ,.
`· th~ f()J"ffi
`attached hereto .as. Exhibit 5oS .
`
`Patent Cooperation. The parties agree that they shall fully cooperate with one
`.2,.6
`another and provide each other with all information and assistance necessary for the l)roseeudon
`of U.S. Patent Application No. 10/518.016. filed June 13,2003 (published as US.20060025391~
`A 1 on Febmary 2~ 2006), any continuation. divisional, continuation·in-.part, reissue,
`reexamination or interference thereof. and the patent applications in Canada and Mexico that
`correspond to and are the Canadian and Mexican equivalents of such U.S. patent applications
`(collectively referred to herein as nthe Patent Applications"). Cipla shall instruct its patent
`counsel to keep MedPointe fulJy informed of the substance and status of the prosecution of the
`Patt."nt Applications and shall obtain MedPointe's comments and suggestions prior to taking any
`material actions in the prosecution of the Patent Applications. The parties also agree that Cipla
`and/or its counsel will take all actions in the prosecution of the Patent Applications that are
`reasonably recommended and/or requested by MedPointe that would expand and/or maximize
`the scope of the rights sought~- provided ifCip1a incurs any additional expense towards this
`exercise then MedPointe will reimburse the same to Cipla.
`
`ARTICLE. VI, PUR.CHASE AND·DELIVER.Y
`
`General Obligation to Purchase. During the Term and subject to the terms and
`conditions of this Agreement, MedPointe shall purchase eighty percent (80%) ofits requirements
`of the Prollnct fnr the Territory from Cipla, and Cip1a shall manufacture, test~ sen and deliver to
`MedPointe. eighty percent (800.4) ofMedPointe's requirements of the Product for the Territory.
`
`Purchase Orders and Forecasts.
`
`MedPointe shalt place orders ("Purchase Orders") specifying the quantity
`of the Product wishes to purchase and such other commercially reasonable terms agreed upon
`by the Parties. Cipla shall accept all conforming Purchase Orders submitted by MedPointe
`pursuant hereto within five (5) days of Cipla' s receipt of such Purchase Order. The terms of this
`Agte·ement shall prevail over any inconsistent terms in any Purchase Order, acknowledgment or
`invoice. Cipla shall fill all conforming Purchase Orders within ten (1 0) days of receipt and will
`achieve a quarterly fill rate of ninety percent (90%), subject to the limitations otherwise
`established by Section 6.2(c) hereof.
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03490392
`
`PTX1 016-00009
`
`9
`
`CIPLA LTD. EXHIBIT 2028 PAGE 9
`
`

`

`Confidential
`
`CipJ~ $hall package and labeL the. Product with J)ackagirtg and labeling
`(b}
`aftW<;>rk ~pproved by MMPointein the quantities and confi.gurations. specified by MedPointe and
`inconformity wiU"rcGMP . andJndu,st:cy practi(;es.
`
`(¢) . . . . Cfpla .and Med:P~int~ sh~li· Work tpgether to minimize waste and tnaxi1nize
`shelf Ute of the Product by roordinating production, inventllry. oo$ntenance Jeyelst Purchase
`Orders a,od .shipmeuts·.as· follows ;
`
`Prior .. to the b~gil1rti~g ofeach calcndar .. quattei) •(A) M&iPciinte
`(i) ....
`shall provide Cipla a forecast of its orders for the .Productfor the following four (4) full
`c!lle~dat •q,Qart~·• and.(B) Cipla •• shau• p}"oviae •. M,edPoit,i~e •with·
`.ateutative •sch~ul~··for· tll~
`production of hlllk batches_ ~vyr ~he s0.me Period. MedPointe shall provide Cipla witftits
`Hrstforecast andPurcbase Order for tb~ Productthree{~) full calendar mouth(~) prior to
`tb<: d!tte for fi;rst the a;uticiPated L~ch within the Terrjtory~< a.s det~rrnil1ed by
`MedPoihte.
`
`The first quarterly period in each four (4)~calendar-quarter estimate
`(ii)
`provided by MedPointe under Section 6.2(c)(i) hereof shaH constitute a binding
`commitment to issue Purchase Orders for the Pmduct during that quarter in an amount
`equal to the forecast amount, and MedPointe shall issue conforming Purchase Orders
`from time to time specifying quantities and delivery dates during such
`quarter.
`Cipla shall use its commerciaUy reasonable efforts to meet MedP
`requested
`delivery dates. which shall be within ten ( l 0) days after the date Cipla receives each
`applicable conforming Purchase Order. For avoidance of any doubt, if the PO quantities
`are less than the binding forecast provided by Medpointe and Cipla has completed
`manufacturing as per the binding forecast~ then MedPointe will pay for the quantities
`rnanufactured by Cipla as per the bindjng forecast
`
`(iii) Cipla shall not be required to accept Purchase Orders for quantities
`of Product in excess of one hundred and fifty percent (l 50%) of the amount specified in
`the forecast for the relevant calendar quarter, but shaH use connnercially reasonable
`efforts to fill any relevant excess Purchase Order(s). MedPointe shall place Purchase
`Ord~rs in quantitie& in increments equal to Cipla's min1mwn batch size with the
`understanding that Cipla will supp1y the yield ofthe batch.
`
`Delivery.
`
`(a)
`AU sales shall be FOB Mumbai, India, and title and risk of loss to all
`Products shall pass to MedPointe upon tender to a qualified carrier. Cipla shall use MedPointe