Exhibit 10.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LICENSE AND COLLABORATIONAGREEMENT

 

 

BY ANDBETWEEN

 

TAKEDA PHARMACEUTICAL COMPANYLIMITED AND

ULTRAGENYX PHARMACEUTICALINC. JUNE 6,2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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LICENSE AND COLLABORATIONAGREEMENT

 

ThisLicenseandCollaborationAgreement(this“Agreement”)ismadeasofthe6th dayofJune,2016(the“ExecutionDate”)byandbetweenTakedaPharmaceuticalCompany Limited, a company incorporated under the laws of Japan having its principal place ofbusiness at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan (“Takeda”), and Ultragenyx Pharmaceutical Inc., a company incorporated under the laws of California, having itsprincipal place of business at 60 Leveroni Court, Novato, CA 94949, United States(“Ultragenyx”). Ultragenyx and Takeda are sometimes referred to herein individually as a “Party”and collectively as the“Parties.”

 

RECITALS

 

WHEREAS, Takeda has developed certain compounds and productspotentially applicable to rare genetic diseaseindications;

 

WHEREAS, Ultragenyx is a pharmaceutical company with significant experiencewith the development of products for rare genetic disease indications;and

 

WHEREAS,UltragenyxandTakedadesiretoestablishacollaborationforthefurther development and commercialization of certain products potentially applicable to raregenetic disease and otherindications.

 

NOW, THEREFORE, in consideration of the foregoing and the mutual agreementsset forth below, and other good and valuable consideration, the receipt and sufficiency of whichare hereby acknowledged, the Parties agree asfollows:

 

ARTICLE 1  –DEFINITIONS

 

1.1“[***] Development Plans” has the meaning set forth in Section4.3(b).

 

1.2“[***] License Negotiation Period” has the meaning set forth in Section5.1(a).

 

1.3“[***] Option” has the meaning set forth in Section5.1(a).

 

1.4“[***] Option Term” has the meaning set forth in Section5.1(a).

 

1.5“[***] Patent Prosecution” has the meaning set forth in Section12.3(a).

 

1.6“[***] Compound”means[***].

 

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1.7“[***] Product” means any pharmaceutical product that contains a [***] Compound, includingallforms,presentations,strengths,dosesandformulations(includinganymethodof delivery).

 

1.8“[***] Research Plan” has the meaning set forth in Section6.3(a).

 

1.9“AccountingStandards”meanGAAPinthecaseofUltragenyxandIFRSinthecaseof Takeda.

 

1.10“Affiliate” means, with respect to a particular Party, a person, corporation, partnership,or otherentitythatcontrols,iscontrolledbyorisundercommoncontrolwithsuchParty.Forthe purposes of this definition, the word “control” (including, with correlative meaning, theterms “controlledby”or“underthecommoncontrolwith”)meanstheactualpower,eitherdirectlyor indirectly through one or more intermediaries, to direct or cause the direction of themanagement andpoliciesofsuchentity,whetherbytheownershipoffiftypercent(50%)ormoreofthe voting stock of such entity, or by contract orotherwise.

 

1.11“Agreement” has the meaning set forth in thepreamble.

 

1.12“Alliance Manager” means the person appointed by each Party from withintheir respective organization to coordinate and facilitate the communication, interactionand cooperation of the Parties pursuant to thisAgreement.

 

1.13“Applicable Laws” means all applicable statutes, ordinances, regulations, rules, ororders ofanykindwhatsoeverofanyGovernmentalAuthority,includingtheU.S.Food,Drugand CosmeticAct,(21U.S.C.§301etseq.)(the“FFDCA”),PrescriptionDrugMarketingAct,the Generic Drug Enforcement Act of 1992 (21 U.S.C. §335a et seq.), U.S. Patent Act (35 U.S.C.§1 et seq.), Federal Civil False Claims Act (31 U.S.C. §3729 et seq.), and the Anti-KickbackStatute (42U.S.C.§1320a-7betseq.),allasamendedfromtimetotime,togetherwithanyrules, regulations, and compliance guidance promulgatedthereunder.

 

1.14“Bankruptcy Laws” has the meaning set forth in Section15.6(b).

 

1.15“Bayh-DoyleAct”meansthePatentandTrademarkLawAmendmentsActof1980,as amended,codifiedat35U.S.C.§§200-212,aswellasanyregulationspromulgatedpursuant thereto, including 37 C.F.R. Part 401, and any successor statutes orregulations.

 

1.16“[***] License Agreement” means the License Agreement by and betweenUltragenyx and [***].

 

1.17“Breaching Party” has the meaning set forth in Section15.2(a).

 

1.18“Bulk Drug Product” means a Product that has been Manufactured into afinal pharmaceutical product, including drug substance (e.g., tablets or granules) for administrationto humansinaccordancewithApplicableLaws,buthasnotbeenPackagedforuseinClinical Trials or forCommercialization.

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1.19“Business Day” means a day other than Saturday, Sunday or any other day onwhich commercialbankslocatedintheStateofNewYork,U.S.,orJapan,areauthorizedorobligated by Applicable Laws toclose.

 

1.20“Calendar Quarter” means the respective periods of three (3) consecutive  calendar months ending on March 31, June 30, September 30 and December 31; provided, however,that

(a)thefirstCalendarQuarteroftheTermshallextendfromtheEffectiveDatetotheendofthe firstcompleteCalendarQuarterthereafter;and(b)thelastCalendarQuarteroftheTermshall end upon the expiration or termination of thisAgreement.

 

1.21“Calendar Year” means the twelve-month period ending on December 31;provided however, that (a) the first Calendar Year of the Term, shall begin on the Effective Date andend onDecember31,2016;and(b)thelastCalendarYearoftheTermshallendonthedateof expiration or termination of thisAgreement.

 

1.22“Candidate Product” has the meaning set forth in Section6.2(a).

 

1.23“ChangeofControl”of Ultragenyx means if: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of Ultragenyx, or if the percentage ownership of such person or entity in the voting securities of Ultragenyx is increased through stock redemption, cancellation or other recapitalization, and immediately after such  acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then- outstanding voting securities of Ultragenyx; (b) the consummation of a merger, consolidation, recapitalization, or reorganization of Ultragenyx, other than any such transaction, which would result in stockholders or equity holders of Ultragenyx, or an Affiliate of Ultragenyx, immediately prior to such transaction owning at least fifty percent (50%) of the outstanding securities of the surviving entity (or its parent entity) immediately following such transaction;  (c) the stockholders or equity holders of Ultragenyx approve a plan of complete liquidation of Ultragenyx, or an agreement for the sale or disposition by Ultragenyx of all or a substantial portion of Ultragenyx’s assets, other than pursuant to the transaction as described above or to an Affiliate; or (d) the sale or other transfer to a Third Party of all or substantially all of Ultragenyx’s assets which relate to this Agreement.

 

1.24“Claim” has the meaning set forth in Section17.1.

 

1.25“ClinicalTrial”meansanyhumanclinicalstudyortrialofapharmaceuticalproductin the Licensed Field in the Territory, including Phase I Trials, Phase II Trials, Phase III Trialsand Phase IVTrials.

 

1.26“Collaboration Activities” has the meaning set forth in Section2.2(a).

 

1.27“Collaboration Term” means (a) with respect to [***] Products, twenty-four (24) months fromtheEffectiveDateand(b)otherthanwithrespectto[***] Products, five (5) years from the Effective Date, unless, in case of each of the foregoing clauses (a) or (b), (i) extended bymutual agreement of the Parties, or (ii) terminated earlier in accordance with the terms ofthis

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Agreement;providedthatifattheexpirationoftheforegoingperiod,anOptionNegotiation Period is then ongoing, the Collaboration Term with respect to such Option Productwill automatically extend until the earlier of (A) expiration of such Option Negotiation Period or(B) execution of the applicable Option Product LicenseAgreement.

 

1.28“Combination Product” means a Product that is comprised of or contains a Compoundas an active ingredient together with one (1) or more other active ingredients and is sold by aParty, oranyofitsAffiliatesorsublicensees,eitherasafixeddoseorasseparatedosesasone(1) product.

 

1.29“Commercialization” means all activities undertaken in support of thepromotion, marketing, sale and distribution (including importing, exporting, transporting, customsclearance, warehousing,invoicing,handlinganddeliveringtheapplicableProducttocustomers)ofthe applicableProduct,includingManufacturingProductforcommercialsale,salesforceefforts, detailing, advertising, marketing, the creation and approval of Promotional Materials, salesand distribution, pricing, customer and government contracting, and medical affairs,including medical education, medical information, clinical science liaison activities, health economicsand outcomes research, publications and investigator initiated research studies.“Commercialize” means to engage in Commercializationactivities.

 

1.30“Commercialization Plan” means, as applicable, (a) a plan prepared byUltragenyx pursuanttoSection5.3containinganoverviewofthegeneralstrategyandahigh-levelbudget for the promoting and marketing of the Licensed Products in the Ultragenyx Field inthe Territory or (b) a plan prepared by Takeda pursuant to Section 5.3 containing an overview ofthe general strategy for the promoting and marketing of the Licensed [***] Product in the Takeda Field in theTerritory.

 

1.31“Commercially Reasonable Efforts” means with respect to the efforts to be expended,or considerations to be undertaken, by a Party or its Affiliates with respect to any objective,activity ordecisiontobeundertakenunderthisAgreementwithrespecttotheCompoundsorProducts, the commercially reasonable efforts, expertise, and resources commonly used by such Party fora productownedbyitortowhichithasexclusiverightsintheapplicableterritory,which,as comparedwithaProduct,isofsimilarmarketpotential,atasimilarstageinitsdevelopmentor productlife,andinvolvessimilarrisks,allasmeasuredbaseduponthefactsandcircumstances at the time such efforts are due, taking into account issues of: efficacy and safety,the competitivenessofalternativeproductssoldbyThirdParties,theproductprofile(including Labeling), the proprietary protection and regulatory exclusivity, the expected and actual profitability and return on investment, and all other similar relevantfactors.

 

1.32“Committee” has the meaning set forth in Section2.3(a).

 

1.33“CommonStockPurchaseAgreement”meansthecommonstockpurchaseagreement entered into on even date hereof by and between Ultragenyx and Takeda (or one of itsAffiliates) providing for Takeda’s (or one of its Affiliate’s) purchase of common stock ofUltragenyx.

 

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1.34“CompetingProduct”means[***].

 

1.35“Compound”meanstheLicensed[***]Compound,aLicensedAnalogCompound,[***] Compound, Candidate Product or Ultragenyx Pipeline Compound, asapplicable.

 

1.36“Confidential Information” means all non-public or proprietary Information disclosedby a Party to the other Party under this Agreement, which may include ideas,inventions, discoveries, concepts, compounds, compositions, formulations, formulas, practices,procedures, processes, methods, knowledge, know-how, trade secrets, technology, inventories,machines, techniques, development and commercialization plans and related information,designs, drawings, computer programs, skill, experience, documents, apparatus, results, clinicaland regulatory strategies, regulatory documentation, information and submissions pertaining to,or made in association with, filings with any Regulatory Authority, data,including pharmacological, toxicological and clinical data, analytical and quality controldata, manufacturing data and descriptions, Patent and legal data, market data, financial dataor descriptions,devices,assays,chemicalformulations,specifications,material,productsamples andothersamples,physical,chemicalandbiologicalmaterialsandcompounds,andthelike, withoutregardastowhetheranyoftheforegoingismarked“confidential”or“proprietary,”or disclosed in oral, written, graphic, or electronic form. Confidential Information shall include:(a) the terms and conditions of this Agreement; and (b) Confidential Information disclosed byeither Party pursuant to the ConfidentialityAgreement.

 

1.37“Confidentiality Agreement” means the Mutual Confidential Disclosure Agreement dated March 13, 2015 by and between Takeda Pharmaceuticals International, Inc. andUltragenyx PharmaceuticalInc.

 

1.38“Control” means, with respect to any Information, Patent, trademark or otherintellectual property right, ownership or possession by a Party, including its Affiliates, of the ability(without takingintoaccountanyrightsgrantedbyonePartytotheotherPartyunderthetermsofthis Agreement)tograntaccess,alicenseorasublicensetosuchInformation,Patent,trademarkor other intellectual property right without violating the terms of any agreement or other arrangementwith,ornecessitatingtheconsentof,anyThirdParty,atsuchtimethattheParty wouldbefirstrequiredunderthisAgreementtogranttheotherPartysuchaccess,licenseor sublicense.

 

1.39“Cover”, “Covering” or “Covered” means, with respect to a product, technology,process ormethod,that,intheabsenceofownershipoforalicensegrantedunderaValidClaim,the practiceorExploitationofsuchproduct,technology,processormethodwouldinfringesuch ValidClaim(or,inthecaseofaValidClaimthathasnotyetissued,wouldinfringesuchValid Claim if it were toissue).

 

1.40“Cure Period” has the meaning set forth in Section15.2(a).

 

1.41“Data Package” means the Final [***] Data Package, Final Phase II Data Package orFinal Phase III Data Package, asapplicable.

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1.42“Development” means all non-clinical and clinical drug development activities,including toxicology, pharmacology, and other non-clinical efforts, statistical analysis, the performanceof ClinicalTrials,includingtheManufacturingoftheapplicableProductforuseintheClinical Trials, or other activities necessary to obtain or maintain, Regulatory Approval of theapplicable Products.“Development”shallexcludeCommercializationactivities.Whenusedasaverb, “Develop” means to engage in Developmentactivities.

 

1.43“Disclosing Party” has the meaning set forth in Section14.1.

 

1.44“Dispute” has the meaning set forth in Section16.1.

 

1.45“EffectiveDate”meansthedatethisAgreementbecomeseffective,asdeterminedin accordance with Section18.1.

 

1.46“EMA”meanstheEuropeanMedicinesAgencyoranysuccessoragencyorauthority having substantially the samefunction.

 

1.47“EU”meansalloftheEuropeanUnionmemberstatesasoftheapplicabletimeduring the Term.

 

1.48“Execution Date” has the meaning set forth in thepreamble.

 

1.49“Exercised Countries” has the meaning set forth in Section8.2(c).

 

1.50“Exercised Product License Agreement” has the meaning set forth in Section8.2(d).

 

1.51“Exercised Products” has the meaning set forth in Section8.2(c).

 

1.52“Expert” means a disinterested, conflict-of-interest-free individual who is neutraland independent of both Parties and all of their respective Affiliates and sublicensees and who,with respect to a dispute concerning a financial, commercial, scientific or regulatory matter,possesses appropriate expertise to resolve such dispute. Neither the Expert (nor any of the Expert’scurrent orformeremployers)shallbeorhavebeenatanytime,totheKnowledgeoftheParties,an employee,officer,directoror,duringthepreviousfive(5)years,aconsultantorcontractorof either Party or any of itsAffiliates.

 

1.53“Exploit” or “Exploitation” means to research, import, Manufacture, haveManufactured, export distribute, use, have used, sell, have sold, or offer for sale, including toDevelop, Commercialize, register, modify, enhance, improve or otherwise disposeof.

 

1.54“FDA” means the U.S. Food and Drug Administration, or any successor agencythereto.

 

1.55“Final[***]DataPackage”meansallinformationthePartiesagreethatUltragenyxshall providetoorgiveaccesstoTakedaattheconclusionoftheactivitiescontemplatedunderthe Initial [***] Development Plan for a given Licensed [***] Product as it relates to the TakedaField, butwhichwillincludeataminimum(a)validatedandreproducibletables,listingsandgraphs, (b) all adverse event listings, safety narratives, CMC data and information, andapplicable

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RegulatoryDocumentation,(c)preclinicalstudyresultsandfinal,ifpossible,orpreliminary toxicologyandpharmacologyreports,and(d)apreliminaryPhaseIreportandallPhaseI clinicaldata.

 

1.56“Final Phase II Data Package” means on a Product-by-Product basis, all Informationthe Parties agree that Ultragenyx shall provide to or give access to Takeda at the conclusion ofa Phase II Clinical Trial and after database lock, but which will include at a minimum (a)validated and reproducible tables, listings and graphs, (b) all adverse event listings, safety narratives,CMC data and information, and applicable Regulatory Documentation, (c) final, if possible,or preliminarytoxicologyandpharmacologyreports,(d)thePhaseIfinalreportandallPhaseI clinical data, and (e) a preliminary Phase II report and all Phase II clinicaldata.

 

1.57“Final Phase III Data Package” means, on a Product-by-Product basis, all Informationthe Parties agree that Ultragenyx shall provide to or give access to Takeda at the conclusion ofa Phase III Clinical Trial and after database lock, but which will include at a minimum(a) validatedandreproducibletables,listingsandgraphs,(b)alladverseeventlistings,material safety narratives, CMC data and information, and applicable Regulatory Documentation, (c) final, if possible, or preliminary toxicology and pharmacology reports, (d) the Phase I finalreport and all Phase I clinical data to the extent not previously provided to Takeda, (e) the Phase IIfinal reportandallPhaseIIclinicaldatatotheextentnotpreviouslyprovidedtoTakeda,and(f)the preliminary Phase III report and all Phase III clinicaldata.

 

1.58“Finished Product” means Bulk Drug Product that has been Packaged into a formsuitable for use in Clinical Trials or for Commercial purposes (i.e., bottles or blisters), includingsamples, in accordance with ApplicableLaws.

 

1.59“First Commercial Sale” means, on a country-by-country basis, the first sale of aProduct under this Agreement by a Party, its Affiliates or its sublicensees to an end user or prescriberfor use, consumption or resale of the Product in a country in the applicable territory in theapplicable field where Regulatory Approval of the Product has been obtained and where the sale results ina recordableNetSale.SaleofaProductunderthisAgreementbyaPartytoanAffiliateora sublicenseeofsuchPartyshallnotconstituteaFirstCommercialSaleunlesssuchAffiliateor suchsublicenseeistheenduserofsuchProduct.Also,saleofaProductunderthisAgreement byaParty,itsAffiliatesoritssublicenseesinajurisdictionwhereRegulatoryApprovalforthat Product has not yet been attained shall not constitute a First Commercial Sale underthis Agreement.

 

1.60ForceMajeure”meansanyeventbeyondthereasonablecontroloftheaffectedParty including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civilunrest; strikes, lockouts or other labor disturbances; epidemics, fire, floods, earthquakes or other actsof nature; or acts, omissions or delays in acting by any governmental authority (including the refusalofthecompetentgovernmentagenciestoissuerequiredRegulatoryApprovalsdueto reasons other than the affected Party’s negligence or willful misconduct or  any othercause withinthereasonablecontroloftheaffectedParty),andfailureofplantormachinery(provided that such failure could not have been prevented by the exercise of skill, diligence, andprudence

 

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that would be reasonably and ordinarily expected from a skilled and experienced personengaged in the same type of undertaking under the same or similarcircumstances).

 

1.61“FTE” means eighteen hundred (1800) hours of work per full Calendar Year(or equivalentpro-rataportionthereofforaperiodlessthantwelve(12)months)devotedtoorin support of the Development of the applicable Products in accordance with the Research Plansor the Manufacturing of a Product or the provision of Research Support (but excluding, forclarity, time spent travelling to and attending meetings under this Agreement and scientific andmedical conferences), that is carried out by one or more qualified scientific or technical employeesor contractpersonnelofTakedaoritsAffiliates,assuchhoursaremeasuredinaccordancewith Takeda’snormaltimeallocationpractices.Fortheavoidanceofdoubt,FTEonlyappliesto employees of a Party, and does not apply to contractors ofTakeda.

 

1.62“FTECost”means,foranyperiod,theFTERatemultipliedbythenumberofFTEsin suchperiod.

 

1.63“FTE Rate” means a rate of [***] per FTE per Calendar Year (pro-rated for the period beginning on the EffectiveDate and ending at the end of the first Calendar Year) for personnel engaged inDevelopment activities.Suchrateshallbeadjustedannually,witheachannualadjustmenteffectiveasof January1ofeachcalendaryear(withthefirstsuchannualadjustmenttobemadeasofJanuary 1,2018)tocorrespondwiththetotalpercentagechangeintheConsumerPriceIndexforAll UrbanConsumers(CPI-U)fortheU.S.CityAverage,1982-84=100,calculatedbytheU.S. Bureau of Labor Statistics over the twelve (12)-month period preceding each such January1.

 

1.64“GAAP” means generally accepted accounting principles current in theU.S.

 

1.65“Generic Competition Percentage” means, with respect to any Product in a givencountry intheTerritoryorTakedaTerritory(asapplicable),allunitsoftheGenericProduct(s)forsuch Product, sold in the aggregate in such country divided by the sum of: (a) all units of theProduct soldinsuchcountry,and(b)allunitsoftheGenericProduct(s)soldintheaggregateinsuch country,where,ineachcase,thenumberofunitsofaProductandeachGenericProductsold shallbebasedontheaverageofthemonthlyIMSdata(orIMS-equivalentdataifIMSdataare notavailable).

 

1.66“Generic Product” means, on a Product-by-Product and country-by-country basis,any pharmaceutical product sold by a Third Party, other than as a sublicensee to this Agreementthat:

(a) contains the same active ingredients as the applicable Product, in the same dosage form(e.g., oral)astheapplicableProduct;or(b)isA/BRatedwithrespecttosuchProductorotherwise approved by the Regulatory Authority in such country as a substitutable generic forsuch Product; or (c) is approved in the applicable field by a Regulatory Authority pursuant to anNDA filedbyaThirdPartyunderSection505(b)(2)or505(j)(2)oftheFFDCA(oranequivalent RegulatoryApprovalApplicationfiledoutsidetheU.S.),containstheactiveingredientsinthe Product,andreliesonthefindingofsafetyand/oreffectivenessintheRegulatoryApprovalof the Product. For the purposes of this definition, “A/B Rated” means, inside theU.S., “therapeutically   equivalent”   as    determined   by   the   FDA,   applying   the   definition     of

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“therapeutically equivalent” set forth in the preface to the then-current edition of theFDA publication“ApprovedDrugProductsWithTherapeuticEquivalenceEvaluationsand,outside the U.S., such equivalent determination by the applicable Regulatory Authorities as isnecessary to permit pharmacists or other individuals authorized to dispense pharmaceuticalsunder Applicable Law to substitute one product for another product in the absence ofspecific instruction from a physician or other authorized prescriber under ApplicableLaw.”

 

1.67“Good Clinical Practices”, “GCP” or “cGCP” means the then-current standards,practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines adopted by the International Conference on Harmonization (“ICH”), titled “Guidance for Industry E6Good Clinical Practice: Consolidated Guidance,” (or any successor document) includingrelated regulatory requirements imposed by the FDA and comparable regulatory standards, practicesand procedurespromulgatedbytheEMA,PMDAorotherRegulatoryAuthorityapplicabletothe Territory, as they may be updated from time totime.

 

1.68“Good Laboratory Practices”, “GLP”, or “cGLP” means the then-currentstandards, practicesandprocedurespromulgatedorendorsedbytheFDAassetforthin21C.F.R.Part58 (or any successor statute or regulation), including related regulatory requirements imposed bythe FDA and comparable regulatory standards, practices and procedures promulgated by theEMA, PMDAorotherRegulatoryAuthorityapplicabletotheTerritory,astheymaybeupdatedfrom time to time, including applicable guidelines promulgated under theICH.

 

1.69“Good Manufacturing Practices”, “GMP”, or “cGMP” means the then-currentgood manufacturingpracticesrequiredbytheFDA,assetforthintheFFDCA,asamended,andthe regulations promulgated thereunder, for the manufacture and testing of pharmaceuticalmaterials, and comparable Applicable Law related to the manufacture and testing ofpharmaceutical materialsinjurisdictionsoutsidetheU.S.,includingthequalityguidelinepromulgatedbythe ICH designated ICH Q7A, titled “Q7A Good Manufacturing Practice Guidance forActive PharmaceuticalIngredients”andtheregulationspromulgatedthereunder,ineachcaseasthey may be updated from time totime.

 

1.70“Governmental Authority” means any multi-national, federal, state, local, municipalor other government authority of any nature (including any governmental division,subdivision, department, agency, bureau, branch, office, commission, council, court or othertribunal).

 

1.71“Hatch-WaxmanAct”meanstheDrugPriceCompetitionandPatentTermRestoration Act, 21 U.S.C. 355, asamended

 

1.72“House Mark” means the trademark that a Party uses to identify itscommercial operations.

 

1.73“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976,as amended, and the rules promulgatedthereunder.

 

1.74“HSR Conditions” means the following conditions, collectively: (a) the waitingperiod undertheHSRActshallhaveexpiredorearlierbeenterminated;(b)noinjunction(whether

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temporary, preliminary or permanent) prohibiting consummation of the transactioncontemplated by this Agreement or any material portion hereof shall be in effect; (c) no judicialor administrative proceeding opposing consummation of all or any part of this Agreement shallbe pending; and (d) no requirements or conditions shall have been imposed by the UnitedStates Department of Justice or Federal Trade Commission (as applicable) in  connection  withthe filings by the Parties under the HSR Act, other than requirements or conditions thatare satisfactory to the Party on whom such requirements or conditions areimposed.

 

1.75“HSRFiling”meansfilingswiththeUnitedStatesFederalTradeCommissionandthe Antitrust Division of the United States Department of Justice of a Notification and ReportForm for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect tothe subject matter of this Agreement, together with all required documentary attachmentsthereto.

 

1.76“IFRS” means the International Financial Reporting Standards as promulgated bythe International Standards Accounting Board and as they may be updated for time totime.

 

1.77“IND”meansanInvestigationalNewDrugapplicationasdefinedintheFFDCA,as amended, and applicable regulations promulgated hereunder by the FDA, or a clinicaltrial authorization application for a product filed with a Regulatory Authority in any otherregulatory jurisdictionoutsidetheU.S.,thefilingofwhichisnecessarytocommenceorconductclinical testing of a pharmaceutical product in humans in suchjurisdiction.

 

1.78“IND Date” means the date on which ownership of Product INDs is transferred or aright of reference is granted pursuant to Section 9.2(a)(i), in the case of transfers or grantsto Ultragenyx, or pursuant to Section 9.2(b)(i), in the case of transfers toTakeda..

 

1.79“Indemnifying Party” has the meaning set forth in Section17.3(a).

 

1.80“Indemnitee” has the meaning set forth in Section17.3(a).

 

1.81“Information” means information, Inventions, discoveries, compounds,compositions, formulations, formulas, practices, procedures, processes, methods, knowledge, tradesecrets, technology, techniques, designs, drawings, correspondence, computer programs,documents, apparatus, results, strategies, regulatory documentation, information and submissionspertaining to,ormadeinassociationwith,filingswithanyRegulatoryAuthorityorpatentoffice,data, includingpharmacological,toxicological,non-clinicalandclinicaldata,analyticalandquality control data, manufacturing data and descriptions, market data, financial data ordescriptions, devices, assays, chemical formulations, specifications, material, product samples andother samples,physical,chemicalandbiologicalmaterialsandcompounds,andthelike,inwritten, electronic, oral or other tangible or intangible form, now known or hereafter developed,whether or notpatentable.

 

1.82“Initial [***] Development Plan” means the plan (including timeline and budget)covering preliminaryDevelopmentactivitiestobecompletedbyUltragenyxandTakeda(totheextent expresslyprovidedinsuchplan)foraLicensed[***]ProductintheLicensedFieldattached

 

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heretoasExhibit1.82,assuchplanmaybeamendedfromtimetotimepursuanttoSection 2.1(a)(v).

 

1.83“Inventions” means any and all inventions, discoveries and developments, whether ornot patentable, made, conceived or reduced to practice in the course of performance ofthis Agreement,whethermade,conceivedorreducedtopracticesolelyby,oronbehalfof,Takeda, Ultragenyx, the Parties jointly, or any Affiliate of thesame.

 

1.84“Joint Know-How” means all Information included in the JointInventions.

 

1.85“Joint Intellectual Property” means, collectively, Joint Know-How and JointPatents.

 

1.86“Joint Invention” has the meaning set forth in Section12.1(b).

 

1.87“Joint Patents” has the meaning set forth in Section12.3(c).

 

1.88“Joint Research Committee” or “JRC” has the meaning set forth in Section2.2(a).

 

1.89“Joint Steering Committee” or “JSC” has the meaning set forth in Section2.1(a).

 

1.90“Knowledge”means,asappliedtoaParty,thatsuchPartyshallbedeemedtohave knowledgeofaparticularfactorothermattertotheextentthatapersonwithintheKnowledge Group knew of such fact or othermatter.

 

1.91“Knowledge Group” means, with respect to each Party, the individuals holdingthe positions listed on Exhibit 1.91; provided that if one or more of the individuals listed onExhibit

1.191nolongerholdsthesamepositionortitlesetforthoppositehis/hername,(a)suchperson shallcontinuetobeconsideredpartoftheKnowledgeGroup,and(b)his/herreplacementshall also be considered part of the KnowledgeGroup.

 

1.92“Labeling” means the healthcare professional information or patient information usedin the Territory that is part of the Product Regulatory Approval including the packageinsert, medication guides, company core safety information (CCSI) and company core datasheet (CCDS).

 

1.93“Lead Regulatory Party” has the meaning set forth in Section9.1.

 

1.94“Licensed[***]Compound”means[***] as further described on, and with the chemical structure set forth in, Exhibit 1.94.

 

1.95“Licensed [***] Know-How” means Information related to the (a) Licensed[***] Compound, Controlled by Takeda as of the Execution Date or during the Term, and/or(b) Licensed Analog Compound specified in the Agreement Controlled by Takeda as ofthe Execution Date, in each case including data, reports, and materials related to preclinicalstudies, regulatoryfilings/correspondence,andchemistry,manufacturingandcontrolsandnecessaryor

 

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reasonably useful for the Exploitation of a Licensed [***] Compound or a LicensedAnalog Compound.

 

1.96“Licensed [***] Patent” means the Patent that is Controlled by Takeda as of theExecution DateidentifiedastheLicensed[***]PatentonExhibit1.168,andallPatentsControlledby Takeda during the Term that claim priority to suchPatent.

 

1.97“Licensed[***]Product”meansanypharmaceuticalproductthatcontainstheLicensed [***] Compound, including all forms, presentations, strengths, doses and formulations(including any method ofdelivery).

 

1.98“Licensed[***]Technology”meanstheLicensed[***]PatentandLicensed[***]Know- How.

 

1.99“Licensed Analog Compounds” means (a) the compounds with the chemicalstructures listedonExhibit1.99and(b)anystructuresdefinedby [***]whereapprovedbytheJSCpursuanttoSection2.1(a)(iii))[***], that are disclosed in the Licensed [***]Patent and that are developed pursuant to, and as specified in, a mutually agreed research plan conducted by Ultragenyx involving modifications to such structures. Exhibit 1.99 shallbe updated from time to time to include those chemical structures described in theforegoing subclause(b).

 

1.100“Licensed Analog Product” means any pharmaceutical product that contains aLicensed Analog Compound, including all forms, presentations, strengths, doses andformulations (including any method ofdelivery).

 

1.101“Licensed Field” means [***].

 

1.102“Licensed Option Product” means any Option Product for which the Partieshave executed an Option Product LicenseAgreement.

 

1.103“Licensed Product” means the Licensed [***] Products and Licensed Analog Products,as applicable.

 

1.104“Licensed Product Improvement” means any Invention related to the Licensed[***] Compound, Licensed Analog Compounds, or Licensed Products made (a) solely by, or onbehalf of,UltragenyxoritsAffiliatesorsublicenseesunderthisAgreementor(b)solelybyTakedaor itsAffiliatesunderthisAgreement.Forclarity,(i)employeesofUltragenyxoritsAffiliatesor sublicensees, or their respective agents or independent contractors receiving considerationfrom UltragenyxoritsAffiliatesorsublicenseesinthecourseofconductingactivitiesunderthis Agreement,shallbeconsidered“solelyby,oronbehalfof”pursuanttothisSection1.104,and

(ii) neither Takeda nor any of its Affiliates shall, under any circumstances under thisAgreement, be considered an agent or independent contractor of Ultragenyx or any of its Affiliatesor sublicensees for purposes of this Section1.104.

 

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1.105“LicensedProductImprovementPatents”meansPatentsthatCoverLicensedProduct Improvements that do not claim priority (in accordance with Section 1.129) to the Licensed[***] Patent.

 

1.106“Licensed Product Royalty Term” means, on a country-by-country and LicensedProduct- by-Licensed Product basis, the period commencing on the First Commercial Sale ofsuch Licensed Product in such country in the Territory and ending upon the later of (a) ten (10)years after First Commercial Sale of such Licensed Product in such country, (b) the expiration insuch countryofthelastValidClaimfromtheLicensed[***]PatentthatCoversthecomposition,or method of making or using, such Licensed Product, or (c) the expiration of theapplicable Regulatory Exclusivity of a LicensedProduct.

 

1.107“Listed Compounds” has the meaning set forth in Section6.1.

 

1.108“Loss” has the meaning set forth in Section17.1.

 

1.109“Marketing Authorization Application” or “MAA” means an application forRegulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than theU.S.

 

1.110“Manufacture” means all activities related to the manufacturing of a Finished Productor BulkDrugProduct,includingthemanufactureofanyingredientusedtherein,forDevelopment orCommercializationintheTerritory,packaging,in-processandProducttesting,validation, release of Product or any component or ingredient thereof, quality assurance activities relatedto manufacturingandreleaseofProduct,ongoingstabilitytests,PackagingofBulkDrugProduct into Finished Product and regulatory activities related to any of theforegoing.

 

1.111“NDA” means a New Drug Application or supplemental New Drug Applicationas contemplated by Section 505(b) of the FFDCA, as amended, and the regulationspromulgated thereunder,submittedtotheFDApursuanttoPart314ofTitle21oftheU.S.CodeofFederal Regulations, including any amendmentsthereto.

 

1.112“Net Sales” means, with respect to any Product and calculated in accordancewith AccountingStandardsconsistentlyappliedacrossProducts,thegrossrevenuerecognizedbya Party, its Affiliates and sublicensees for sales of such Product to Third Parties, less thefollowing deductions, to the extent such deductions are paid, incurred or otherwise taken, reasonableand customary, provided to Third Parties, and actually allowed with respect to suchsales:

 

(a)reasonablecash,tradeorquantitydiscounts,charge-backpayments,andrebates actuallygrantedtotradecustomers,managedhealthcareorganizations,pharmaceuticalbenefit managers, group purchasing organizations and national, state, or local government;and

 

(b)credits, rebates or allowances actually allowed upon prompt payment oron account of claims, damaged goods, rejections or returns of such Product, including inconnection withrecalls,andtheactualamountofanywrite-offsforbaddebt(nottoexceedonepercent (1%)) (provided that an amount subsequently recovered will be treated as NetSales)

 

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(c)inventory management fees and costs of freight, carrier insurance, andother transportation charges directly related to the distribution of such Product;and

 

(d)taxes, duties or other governmental charges (including (i) any tax such as avalue addedorsimilartax,otherthananytaxesbasedonincome,and(ii)anypaymentsmadetothe PharmaceuticalandMedicalDeviceAgency(“Kiko”)basedonSection19or22ofthe“Acton Pharmaceuticals and Medical Devices Agency (Act No.192 of 2002)”) directly levied onor measured by the billing amount for such Product, as adjusted for rebates andrefunds.

 

Notwithstanding the foregoing, amounts received or invoiced by a Party, its Affiliatesor sublicenseesforthesaleofsuchProductamongaParty,itsAffiliatesorsublicenseesforresale shallnotbeincludedinthecomputationofNetSaleshereunder.Inanyevent,anyamounts received or invoiced by a Party, its Affiliates and sublicensees shall be accounted for onlyonce. ForpurposesofdeterminingNetSales,aProductshallbedeemedtobesoldwhentherevenue generated from such sale is recognized in accordance with the Accounting Standards. EachParty shall record such Net Sales as the “principal” and not the “agent” as defined underthe Accounting Standards. For clarity, a particular deduction may only be accounted for once inthe calculation of Net Sales and no deductions may be made for the annual fee on prescriptiondrug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No.111-148 (as amended). Net Sales shall exclude any samples of a Product transferred or disposed of atno cost for promotional, Development or educationalpurposes.

 

The Net Sales of any CombinationProduct:

 

(i)for which the Product(s) and other active ingredient(s) ofsuch CombinationProductaresoldseparatelybyaParty,oranyofitsAffiliatesorsublicensees,in suchcountry,thenNetSalesforsuchCombinationProductinsuchcountryshallbecalculated bymultiplyingactualNetSalesofsuchCombinationProductinsuchcountrybythefraction A/(A+B), where A is the average Net Sales price of the Product as the only activeingredient(s), as sold separately by a Party or any of its Affiliates or sublicensees in such country, and B isthe averagenetsales(calculatedinamanneranalogoustothemannerinwhichNetSalesare calculatedassetforthabove)priceoftheotheractiveingredient(s)intheCombinationProduct as sold separately by a Party or any of its Affiliates or sublicensees in suchcountry;

 

(ii)forwhichthe(A)LicensedProductofsuchCombinationProductis/are soldseparatelybyaPartyoranyofitsAffiliatesorsublicenseesinsuchcountryand(B)the other active ingredient(s) in the Combination Product is/are not sold separately by a Party orany of its Affiliates or sublicensees in such country, then Net Sales for such Combination Productin such country shall be calculated by multiplying actual Net Sales of such Combination Productin such country by the fraction A/D, where A is the average Net Sales price of the LicensedProduct as the only active ingredient(s), as sold separately by a Party or any of its Affiliatesor sublicensees in such country, and D is the average Net Sales price of the Combination Productas sold separately by a Party or any of its Affiliates or sublicensees in such country;and

 

(iii)for which neither clause (i) nor clause (ii) above is applicable, theParties shalldetermineNetSalesforsuchCombinationProductinsuchcountrybymutualagreement

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basedontherelativecontributionoftheLicensedProductandtheotheractiveingredient(s)in the CombinationProduct.

 

1.113“Neutral Expert” has the meaning set forth in Section16.3(a).

 

1.114“Non-breaching Party” has the meaning set forth in Section15.2(a).

 

1.115“Notice Date” has the meaning set forth in Section16.3(a).

 

1.116“Option Negotiation Period” has the meaning set forth in Section6.12(a).

 

1.117“Option Notice” has the meaning set forth in Section6.12(a).

 

1.118“Option Product” means (a) a Candidate Product selected pursuant to Section 6.10 or(b) a [***] Product, asapplicable.

 

1.119“Option Product Improvements” means any Invention related to a [***] Product oranother Research Product made (a) solely by, or on behalf of, Ultragenyx or its Affiliates orsublicensees under this Agreement, or (b) solely by Takeda or its Affiliates under this Agreement. Forclarity,

(i) employees of Ultragenyx or its Affiliates or sublicensees, or their respective agentsor independent contractors receiving consideration from Ultragenyx or its Affiliates orsublicensees in the course of conducting activities under this Agreement, shall be considered “solely by, oron behalfof”pursuanttothisSection1.119,and(ii)neitherTakedanoranyofitsAffiliatesshall, under any circumstances under this Agreement, be considered an agent or independentcontractor of Ultragenyx or any of its Affiliates or sublicensees for purposes of this Section1.119.

 

1.120“Option Product Improvement Patents” means Patents Covering OptionProduct Improvements.

 

1.121“Option Product Key Terms” has the meaning set forth in Section6.10(a).

 

1.122“Option Product Know-How” means all Information Controlled by Takeda as ofthe Execution Date and during the Term that is necessary or reasonably useful for, as applicable,(a) UltragenyxtoevaluatewhethertoexercisetheUltragenyxOptionor(b)UltragenyxtoExploit anOptionProductsolelyinaccordancewiththeactivitiestobeperformedbyUltragenyxorits Affiliates or sublicensees under the Option Product ResearchPlan.

 

1.123“Option Product License Agreement” has the meaning set forth in Section6.12(a).

 

1.124“OptionProductPatents”meansallPatentsControlledbyTakedaasoftheExecution Date and during the Term that are necessary or reasonably useful for the Exploitation ofthe Option Product(s) in the Ultragenyx Field in theTerritory.

 

1.125“Option Product Research Plan” has the meaning set forth in Section6.10(a).

 

1.126“Option Product Technology” means the Option Product Patents and OptionProduct Know-How.

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1.127“Packaging”meansallactivitiesrelatedtothepreparationofBulkDrugProductinto Finished Product, including application of the approved Labeling. “Packaged” means thatBulk Drug Product has been subject to completePackaging.

 

1.128“Party” has the meaning set forth in thepreamble.

 

1.129“Patents” means all patents, including any utility or design patent, and allapplications thereof, including any provisional application, whether in the Territory or any otherjurisdiction; any other patent or patent application claiming priority to (a) any such specified patent orpatent applicationor(b)anypatentorpatentapplicationfromwhichsuchspecifiedpatentorpatent application claim priority; and (c) all divisionals, continuations, continuationsin-part, registrations, reissues, re-examinations, renewals, supplemental protection certificates,or extensions of (a) or(b).

 

1.130“Patent Term Extension” means any term extensions, supplementaryprotection certificates and equivalents thereof offering Patent protection beyond the initial term withrespect to any issuedPatents.

 

1.131“Person” means an individual, sole proprietorship, partnership, limitedpartnership, limitedliabilitypartnership,corporation,limitedliabilitycompany,businesstrust,jointstock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of agovernment.

 

1.132“Phase I Trial” means a clinical trial of a Product with the endpoint of determininginitial tolerance, safety, pharmacokinetic or pharmacodynamic information in single dose,single ascending dose, multiple dose and/or multiple ascending doseregimens.

 

1.133“Phase II Trial” means a clinical trial of a Product on patients, includingpossibly pharmacokinetic,pharmacodynamicanddose-rangingstudies,theprincipalpurposesofwhich aretomakeapreliminarydeterminationthatsuchproductissafeforitsintendeduseandto obtain sufficient information about such product’s efficacy or dose-response informationto permit the design of further clinicaltrials.

 

1.134“PhaseIIITrial”meansapivotalclinicaltrialofaProductonasufficientnumberof patients,whichtrialisdesignedto(a)establishthataproductissafeandefficaciousforits intended use; (b) define warnings, precautions and adverse reactions that are associated withthe product in the dosage range to be prescribed; and (c) pivotal to support submission ofa Regulatory Approval Application for suchproduct.

 

1.135“PhaseIVTrial”meansaclinicaltrialofaProduct,includingpharmacokineticstudies, whichtrial(a)isnotrequiredinordertoobtainRegulatoryApprovalofanindication;and(b) either(i)isrequiredbytheRegulatoryAuthorityasmandatorytobeconductedonorafterthe RegulatoryApprovalofanindication,or(ii)isconductedvoluntarilytoenhancemarketingor scientificknowledgeoftheproduct(e.g.,providingadditionaldrugprofile,outcomesresearch, safety data or marketing support information, or supporting expansion of productlabeling).

 

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1.136“PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency andany successor agency(ies) or authority having substantially the samefunction.

 

1.137“Preexisting Third Party IP” means those intellectual property rights owned orcontrolled by Third Parties as of the Execution Date that are necessary or reasonably useful forthe Exploitation of Licensed Products and which are set forth in Exhibit1.137.

 

1.138“Pricing Approval” means governmental approval, agreement, determination ordecision establishingpricesthatcanbechargedand/orreimbursedforaProductinajurisdictionwhere the applicable Governmental Authority or Regulatory Authority approves or determinesthe pricing of pharmaceuticalproducts.

 

1.139“Product” means any Licensed [***] Product, Licensed Analog Product, LicensedOption Product or Ultragenyx Pipeline Product, as applicable.

 

1.140“ProductComplaint”meansalldata,whichcometotheattentionofeitherParty,its Affiliates or its sub-licensees, concerning any dissatisfaction regarding a Product of such anature and magnitude that it is required under Applicable Laws to be collected, maintained andreported to a Regulatory Authority, including reports of actual or suspected producttampering, contamination, mislabeling or inclusion of improperingredients.

 

1.141“ProductIND”meansanyINDfiledintheTerritoryrelatedtoaProduct,whetherin existence as of the Effective Date or filed with the FDA during the Term, includingany supplements or amendments thereto. The Product INDs as of the Execution Date are set forthon Exhibit 1.141.

 

1.142“Product Liabilities” means all losses, damages, fees, costs and other liabilitiesincurred byaParty,itsAffiliateoritssublicenseeandresultingfromorrelatingtotheanyuseofa Compound and/or a Product in a human (including in Clinical Trials and/or pursuantto Commercialization) in the Territory, other than any losses, damages, fees, costs andother liabilitiesthatarearesultofaParty’s,itsAffiliates’oritssublicensee’snegligence,willful misconductorbreachofsuchParty’srepresentationsandwarrantiesmadehereunder.Forthe avoidance of doubt, Product Liabilities include, reasonable attorneys’ and experts’ fees andcosts relatingtoanyclaimorpotentialclaimagainstaParty,itsAffiliate,oritssublicenseeandall losses, damages, fees, costs. Product Liabilities shall not include liabilities  associatedwith recalls and/or the voluntary or involuntary withdrawal of the Compound and/or aProduct.

 

1.143“PromotionalMaterials”meansallwritten,printed,graphic,electronic,audioorvideo presentations of information, including journal advertisements, sales visual aids,formulary binders, reprints, direct mail, direct-to-consumer advertising, disease awarenessmaterials, internetpostings,broadcastadvertisementsandsalesreminderaides(forexample,notepads, pens and other such items, if appropriate) intended for use or used by or on behalf of a Party,its Affiliates or its sublicensees in connection with the Commercialization of a Product inthe Territory.

 

 

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1.144“Product Regulatory Approval” means any Regulatory Documentation filed inthe TerritorywhichisrelatedtoaProductintheLicensedField,whetherinexistenceasofthe Effective Date or filed with the applicable Regulatory Authority during the Term, includingany supplements or amendmentsthereto.

 

1.145“Product Trademarks” has the meaning set forth in Section5.5(a).

 

1.146“PVA” has the meaning set forth in Section9.8(a)(i).

 

1.147“Receiving Party” has the meaning set forth in Section14.1.

 

1.148“Regulatory Approval” means any approval or authorization, includingPricing Approvals, of any Regulatory Authority that is necessary for the Manufacture, use,storage, import, transport and/or sale of a Product in accordance with ApplicableLaws.

 

1.149“Regulatory Approval Application” means an NDA or BLA, or anycorresponding application for Regulatory Approval in the Territory, including: (a) with respect to theEuropean Union, an MAA filed with the EMA pursuant to the Centralized Approval Procedure or withthe applicable Regulatory Authority of a country in Europe with respect to thedecentralized procedure,mutualrecognitionoranynationalapprovalprocedure;and(b)anMAAfiledwith thePMDA,including,ineachcase,allsupplements,amendments,variations,extensionsand renewalsthereof.

 

1.150“Regulatory Authority” means any applicable Governmental Authority involvedin granting Regulatory Approval in a country or jurisdiction in the Territory, including in theU.S., the FDA and any other applicable Governmental Authority in the U.S. having jurisdiction overa Product;intheEU,theEMAoranycompetentGovernmentAuthorityintheEU;inJapan,the PMDA; and any other applicable Governmental Authority having jurisdiction over aProduct.

 

1.151“Regulatory Documentation” means, with respect to each Research Product orLicensed Product,all:(a)RegulatoryMaterials,includingalldatacontainedthereinandallsupporting documentscreatedfor,submittedtoorreceivedfromanapplicablegovernmentalagencyor Regulatory Authority relating to such Regulatory Materials; and (b) other documentationor InformationControlledbyaPartywhichisnecessaryorreasonablyusefulinordertoExploit suchProductintheapplicableFieldintheTerritory,includinganyregistrationsandlicenses, regulatory drug lists, advertising and promotion documents shared with RegulatoryAuthorities, adverse event files, complaint files and Manufacturingrecords.

 

1.152“Regulatory Exclusivity” means any exclusive marketing rights or data protection or otherexclusivityrightsconferredbyanyRegulatoryAuthoritywithrespecttoaProductina country or jurisdiction in the Territory, other than a Patent right, including orphandrug exclusivity,pediatricexclusivity,rightsconferredintheU.S.undertheHatchWaxmanAct,in the EU under Directive 2001/83/EC, as amended, and Regulation (EC) No. 1901/2006,as amended,orintheBiologicsPriceCompetitionActassetforthinthePatientProtection& Affordable Care Act, or rights similar thereto in other countries or regulatory jurisdictions inthe Territory.

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1.153“Regulatory Materials” means, with respect to each Product, alldocumentation, correspondence, submissions and notifications submitted to or received from aRegulatory Authority that are necessary or reasonably useful in order to Exploit such Product inthe applicable field in the Territory. For the avoidance of doubt, Regulatory Materials shallinclude, with respect to each Product, all INDs, Regulatory Approval Applications,Regulatory Approvals,PricingApprovalsandamendmentsandsupplementsforanyoftheforegoing,as well as the contents of any minutes from meetings (whether in person or by audio conferenceor videoconference) with a RegulatoryAuthority.

 

1.154“Representative Expert” has the meaning set forth in Section16.3(b).

 

1.155“Research Materials” has the meaning set forth in Section6.6(a).

 

1.156“Research Plan” means a [***] Research Plan or Option Product Research Plan,as applicable.

 

1.157“Research Product” means a [***] Product, Candidate Product or Option Product,as applicable.

 

1.158“Research Support” has the meaning set forth in Section7.1.

 

1.159“SeniorOfficer”meanstheHeadofResearch&Developmentorhisorherdesignee,in thecaseofTakedaand,theChiefExecutiveOfficerorhisorherdesignee,inthecaseof Ultragenyx.

 

1.160“Takeda [***] License” means the licenses granted to Takeda in Section3.2.

 

1.161“Takeda Field” means [***].

 

1.162“Takeda Indemnitee” has the meaning set forth in Section17.1.

 

1.163“Takeda Option” has the meaning set forth in Section8.1.

 

1.164“Takeda Option Field” means all human indications other than the Takeda Fieldfor Licensed [***] Products, and all human indications for Licensed Analog Products,Licensed Option Products and Ultragenyx PipelineProducts.

 

1.165“Takeda Option Negotiation Period” has the meaning set forth in Section8.2(d).

 

1.166“Takeda Option Notice” has the meaning set forth in Section8.2(c).

 

1.167“Takeda Option Term” means the period beginning on the Effective Date and endingon theearlierof(a)[***]aftertheEffectiveDateor(b)withrespecttoaLicensed[***] Product, Licensed Analog Product, Licensed Option Product, or Ultragenyx Pipeline Product,as

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the case may be: (i) [***] after Takeda’s receipt of the applicableFinal PhaseIIDataPackagefortheapplicableLicensed[***]Product,LicensedAnalogProductor Licensed Option Product, (ii) [***] after Takeda’s receipt of theFinal Phase II Data Package (or Final Phase III Data Package in the case of [***]) for theapplicable UltragenyxPipelineProduct(otherthan[***])and(iii)[***]afterTakeda’sreceiptof the Final Phase II Data Package for [***]. Notwithstanding the foregoing, (a) in the event ofa [***]ofUltragenyx[***],theTakedaOptionTermwillexpirewithrespecttoallapplicableproducts(i.e.,any Licensed [***] Product, Licensed Analog Product, Licensed Option Product, orUltragenyx Pipeline Product) [***]; and (b) inthe event of a [***] of Ultragenyx at any time [***],theTakedaOptionTermwillexpire with respect to all applicable products (i.e., any Licensed [***] Product, Licensed AnalogProduct, LicensedOptionProduct,orUltragenyxPipelineProduct)[***]aftertheclosingof such [***].

 

1.168“TakedaPatents”meanstheLicensed[***]PatentandanyPatentthatclaimspriority(in accordance with Section 1.129) to the Licensed [***] Patent during the Term, and theUltragenyx PipelineImprovementPatentsControlledbyTakedaoritsAffiliates.TheTakedaPatentsasof the Execution Date are set forth on Exhibit1.168.

 

1.169“Takeda Product Infringement” has the meaning set forth in Section12.6(b)(i).

 

1.170“Takeda ROFN Territory” meansJapan.

 

1.171“Takeda Royalty Term” means, on a country-by-country and ExercisedProduct-by- Exercised Product basis, the period commencing on the First Commercial Sale of suchExercised Product in a country in the Takeda Territory by Takeda, its Affiliates, or sublicensees thatoccurs after Takeda’s exercise of the Takeda Option and ending upon the later of (a) ten (10) yearsafter First Commercial Sale of such Exercised Product, (b) the expiration of the last Valid Claimthat Covers the composition, or method of making or using, such Exercised Product and issuedfrom thefollowing,asapplicabletotheparticularExercisedProduct:a(i)Licensed[***]Patent,(ii) Option Product Patent that Covers a Licensed Option Product that is subject to an activeOption Product License Agreement or (iii) Ultragenyx Pipeline Patent that Covers anUltragenyx Pipeline Product, or (c) the expiration of the applicable Regulatory Exclusivity forsuch ExercisedProduct.

 

1.172“Takeda Territory” means, (i) with respect to Licensed Products and LicensedOption Products, Japan and Asia and (ii) with respect Ultragenyx Pipeline Products,Japan.

 

1.173“Tax Conditions” means, with respect to the premium being paid by Takedato Ultragenyx under the Common Stock Purchase Agreement, Ultragenyx’s confirmation ofreceipt of the tax residence certificate (IRS Form 6166) from the U.S. Internal RevenueService specifiedinSection11.11(c)andappropriatesubmissionofsuchcertificateandrequiredforms and information with the Osaka Regional TaxationBureau.

 

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1.174“Term” has the meaning set forth in Section15.1.

 

1.175“Terminated Product” means any: (a) Option Product for which an OptionProduct LicenseAgreementhasnotbeenexecutedduringtheOptionNegotiationPeriodinaccordance with Section 6.12(a); (b) Research Product terminated pursuant to Section 6.7(d) or 18.5;(c) Licensed[***]CompoundorLicensed[***]ProductthatrevertstoTakedapursuanttoSection 4.3(f); or (d) Licensed Product or Research Product terminated pursuant to Section 15.2, 15.4or 15.5.

 

1.176“Territory” means worldwide.

 

1.177“ThirdParty”meansaPersonotherthanTakedaandUltragenyxandtheirrespective Affiliates.

 

1.178“Ultragenyx [***] Know-How” means all Information related to the Licensed[***] Compound Controlled by Ultragenyx during theTerm.

 

1.179“Ultragenyx [***] License” means the licenses granted to Ultragenyx in Section3.1.

 

1.180“Ultragenyx [***] Patents” means all Patents Controlled by Ultragenyx or its Affiliatesas of the Execution Date or during the Term that are necessary or reasonably useful forthe ExploitationoftheLicensed[***]CompoundorLicensedAnalogCompoundintheLicensed Field in the Territory, but expressly excluding any Licensed Product Improvement Patents.The Ultragenyx [***] Patents as of the Execution Date are set forth on Exhibit1.188.

 

1.181“Ultragenyx[***]Technology”meanstheUltragenyx[***]PatentsandUltragenyx[***] Know-How.

 

1.182“Ultragenyx Field” means the Licensed Field, excluding the TakedaField.

 

1.183“Ultragenyx In-License Agreement” means [***] and(g)any other applicable agreement between Ultragenyx (or its Affiliates) and a Third Party underwhich Takeda is granted a sublicense or other right under thisAgreement.

 

1.184“Ultragenyx Indemnitee” has the meaning set forth in Section17.2.

 

1.185“UltragenyxKnow-How”meansallInformationControlledbyUltragenyxduringthe Term that is necessary or reasonably useful to Exploit a Compound or a Product in theLicensed Field.

 

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1.186“Ultragenyx Intellectual Property” means, collectively, Ultragenyx Know-Howand UltragenyxPatents.

 

1.187“Ultragenyx Option” has the meaning set forth in Section6.11.

 

1.188“Ultragenyx Patents” means all Ultragenyx [***] Patents, Licensed ProductImprovement Patents Controlled by Ultragenyx or its Affiliates, Option Product ImprovementPatents Controlled by Ultragenyx or its Affiliates and Ultragenyx Pipeline Patents. TheUltragenyx Patents as of the Execution Date are set forth on Exhibit1.188.

 

1.189“Ultragenyx Pipeline Compound” means the active ingredient in an UltragenyxPipeline Product.

 

1.190“Ultragenyx Pipeline Improvements” means any Invention related to anUltragenyx PipelineProductmade(a)solelyby,oronbehalfof,TakedaoritsAffiliatesorsublicensees under this Agreement or (b) solely by Ultragenyx or its Affiliates under this Agreement.For clarity,(i)employeesofTakedaoritsAffiliatesorsublicensees,ortheirrespectiveagentsor independent contractors receiving consideration from Takeda or its Affiliates or sublicenseesin thecourseofconductingactivitiesunderthisAgreement,shallbeconsidered“solelyby,oron behalfof”pursuanttothisSection1.190,and(ii)neitherUltragenyxnoranyofitsAffiliates shall,underanycircumstancesunderthisAgreement,beconsideredanagentorindependent contractor of Takeda or any of its Affiliates or sublicensees for purposes of this Section1.190.

 

1.191“Ultragenyx Pipeline Improvement Patents” means Patents that CoverUltragenyx Pipeline Improvements.

 

1.192“Ultragenyx Pipeline Patents” means all Patents Controlled by Ultragenyx as ofthe Execution Date and during the Term that: (a) claim the composition of matter of, or themethod of making or using an Ultragenyx Pipeline Product; or (b) are otherwise necessary orreasonably useful to Exploit an Ultragenyx Pipeline Product in the Licensed Field. The UltragenyxPipeline Patents for the Takeda Territory as of the Execution Date are set forth on Exhibit1.188.

 

1.193“Ultragenyx Pipeline Products” means all products that have entered into ClinicalTrials and are Controlled by Ultragenyx or its Affiliates during the Collaboration Term andthat Ultragenyx or its Affiliates have rights to Commercialize in the Takeda ROFNTerritory, [***].Forpurposesofthis Section 1.193, “Controlled” shall not include [***]

 

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[***].

 

1.194“Ultragenyx Product Infringement” has the meaning set forth in Section12.6(b)(i).

 

1.195“UX[***]” means the compound having Ultragenyx reference number UX[***] asfurther described on Exhibit1.195.

 

1.196“UX[***]” means the compound having Ultragenyx reference number UX[***] asfurther described on Exhibit1.195.

 

1.197“UX[***]”meansthecompoundhavingUltragenyxreferencenumberUX[***]asfurther described on Exhibit1.195.

 

1.198“UX[***]” means the compound having Ultragenyx reference number UX[***] asfurther described on Exhibit1.195.

 

1.199“UX[***]”meansthecompoundhavingUltragenyxreferencenumberUX[***]asfurther described on Exhibit1.195.

 

1.200“ValidClaim”meansaclaimofanissuedandunexpiredPatentincludedwithinthe Takeda Patents, the Ultragenyx Patents or the Joint Patents, to the extent such claim has notbeen revoked, held invalid or unenforceable by a patent office, court or other governmental agencyof competentjurisdictioninafinalorder,fromwhichnofurtherappealcanbetaken,andwhich claim has not been disclaimed, denied or admitted to be invalid or unenforceable throughreissue, re-examination ordisclaimer.

 

1.201“Validation Research Plan” has the meaning set forth in Section6.2(b).

 

ARTICLE 2  – OVERVIEW;MANAGEMENT

 

2.1Joint Steering Committee for LicensedProducts.

 

(a)Formation and Purpose. Within thirty (30) days after the Effective Date,the PartiesshallpromptlyestablishandconveneaJointSteeringCommittee(the“JointSteeringCommittee” or “JSC”) in accordance with Section 2.3(c)(i) that will direct and overseeactivities relating to the Licensed Products under this Agreement. The JSC shall consist ofrepresentatives andoperatebytheproceduresinaccordancewithSection2.3.Exceptasotherwiseprovided herein, the role of the Joint Steering Committee shallbe:

 

(i)to encourage and facilitate ongoing communication andcooperation betweenthePartieswithrespecttotheExploitationbythePartiesofLicensedProductsinthe Licensed Field;

 

 

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(ii)to serve as a forum for sharing discoveries and exchanging data andresults generated by each Party relating to additional compounds Covered by the Licensed [***]Patent;

 

(iii)to evaluate and approve the inclusion as Licensed Analog Compounds of additionalcompoundsthatareCoveredbytheLicensed[***]Patentbutthatdonotmeetthe definition of Licensed Analog Compounds [***];

 

(iv)to evaluate and approve the exclusion from the definition ofLicensed AnalogCompoundsofadditionalcompoundsthatareCoveredbytheLicensed[***]Patent[***];

 

(v)to review and discuss [***] Development Plans and anyproposed amendments or revisions to the [***] DevelopmentPlans;

 

(vi)to review and discuss Commercialization Plans including the reviewand discussion of any amendments to such CommercializationPlans;

 

(vii)to review and discuss Licensed Product regulatory issues, includingthose raisedbythejointregulatoryaffairsworkinggroupestablishedpursuanttoSection2.1(a)(viii) and Section9.4(a);

 

(viii)toestablishothersuchworkinggroupsorsubcommittees,asneededto furtherthepurposesoftheAgreementrelatingtoLicensedProducts,asmutuallyagreedbythe Parties inwriting;

 

(ix)to resolve any disputes referred to the JSC;and

 

(x)to approve or decide such other matters as provided in thisAgreement.

 

|   | (b) | JSC Decisions; Final DecisionAuthority. |   |
|--------|-----|-----------------------------------------|--------|

 

(i)The JSC will make good faith efforts to make all decisions byconsensus. Except as set forth in Section 2.1(b)(ii), actions to be taken by the Joint Steering Committeeshall betakenonlyfollowingunanimousvote,witheachParty’srepresentativescollectivelyhaving one(1)vote.IftheJointSteeringCommitteefailstoreachunanimousagreementonamatter beforeitfordecisionforaperiodinexcessoffifteen(15)daysfromthedatefirstpresentedto theJSCinwriting,eitherPartymaysubmitsuchmatterforresolutiontotheSeniorOfficersof thePartiesforattemptedresolutionbygoodfaithnegotiationwithinthirty(30)daysaftersuch notice is received by the SeniorOfficers.

 

(ii)If the Senior Officers of the Parties are unable to resolve suchdispute withinsuchthirty(30)dayperiod,suchdisputeshallberesolvedduringtheTermasfollows. For the avoidance of doubt, the right of a Party to make final decisions with respect to anyissue

 

 

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shall not otherwise diminish or eliminate such Party’s obligations under thisAgreement, including its obligation to exercise Commercially Reasonable Efforts where requiredherein.

 

(A)Subject to Sections 2.1(b)(ii)(D) and 2.1(b)(ii)(E) andprovided that such decision does not result in an increase in the scope of work or costs associatedwith the performance of any activities by Takeda under this Agreement, Ultragenyx will havefinal decisionmakingauthorityover[***];and

 

(B)Takeda will have final decision making authority over[***].

 

(C)Takeda will have final decision making authority over[***].

 

 

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(D)IfUltragenyxexercisesthe[***]Optionwithinthe[***]Option Termfortheco-Developmentandco-CommercializationofLicensed[***]Productsinthe Takeda Field in the Territory, Takeda will have final decision making authority over[***].

 

(E)IfUltragenyxdoesnotexercisethe[***]Optionwithinthe[***] Option Term for the co-Development and co-Commercialization of Licensed [***] Productsin theTakedaFieldintheTerritory,(a)Ultragenyxwillcontinuetohavefinaldecisionmaking authority over [***],and(b)Takedawillcontinuetohavefinaldecisionmakingauthorityover [***].

 

(F)Takeda shall have final decision making authority over[***];

 

(G)Ultragenyx shall have final decision making authorityover [***].

 

(iii)Neither Party shall have the final decision making authority for anyother matter under the purview of the JSC and not covered by subsections (A)-(G), and the statusquo shall persist with respect to such matter if the Parties are unable to agree. For clarity, theParties anticipatethatLicensedOptionProductsandExercisedProductswillbegovernedbyseparate committeesandfinaldecisionmakingauthoritytobeestablishedpursuanttotheapplicable Option Product License Agreement or Exercised Product License Agreement,respectively.

(c)Discontinuation of JSC. Upon the second (2nd) anniversary of the Effective Date or any time thereafter, Ultragenyx shall have the right, upon written notice to Takeda,to

 

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discontinueitsparticipationintheJSC.OnceUltragenyxhasprovidedsuchnoticetoTakeda, the JSC shall have no further obligations under this Agreement and, thereafter, Takeda shallhave final decision making authority with respect to the topics that were otherwise determined bythe JSC, subject to the other terms and conditions of thisAgreement.

 

|   | 2.2 | Joint Research Committee for CollaborationActivities. |
|--------|-----|-------------------------------------------------------|

 

(a)Formation and Purpose. Within thirty (30) days after the Effective Date, the PartiesshallpromptlyestablishandconveneaJointResearchCommittee(the“JointResearchCommittee”or“JRC”)inaccordancewithSection2.3(c)(i)fortheoverallcoordinationand oversight of the Collaboration Activities.  The JRC shall consist of representatives andoperate by the procedures in accordance with Section 2.3. Except as otherwise provided herein, theJoint Research Committee shall be responsible for supporting the [***] in assessing, prioritizing, and advancing Takeda’s rare genetic diseaseproducts, including the following specific activities (collectively, “CollaborationActivities”):

 

(i)review and approve the Validation Research Plan and any amendments thereto;

 

(ii)review and approve the Option Product Research Plans and any amendments thereto;

 

(iii)review and approve any amendments to the [***] Research Plan;

 

(iv)evaluate and prioritize [***];

 

(v)support the overall direction of Candidate Product and Option Product strategy;

 

(vi)identify, define, and support collaborations with key experts and investigators and other third parties in support of the prioritized Candidate Products, Option Products and related indications;

 

(vii)identify and implement opportunities [***];

 

(viii)determine the [***]; and

 

(ix)oversee and manage the secondee program provided for in Section 2.6.

 

(b)Termination of Responsibilities. Upon execution of an Option ProductLicense Agreement for an Option Product, the JRC will no longer have any responsibility  overor decision making authority relating to such OptionProduct.

 

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|   | (c) | JRC Decisions; Final DecisionAuthority. |   |
|--------|-----|-----------------------------------------|--------|

 

(i)TheJRCwillmakegoodfaitheffortstomakealldecisionsbyconsensus ExceptassetforthinSection2.2(c)(ii),actionstobetakenbytheJointResearchCommittee shallbetakenonlyfollowingunanimousvote,witheachParty’srepresentativescollectively having one (1) vote. If the Joint Research Committee fails to reach unanimous agreement ona matterbeforeitfordecisionforaperiodinexcessoffifteen(15)daysfromthedatefirst presented to the JRC in writing, either Party may submit such matter for resolution to theSenior Officers of the Parties for attempted resolution by good faith negotiation within thirty (30)days after such notice is received among the SeniorOfficers.

 

(ii)If the Senior Officers of the Parties are unable to resolve suchdispute within such thirty (30) day period, such dispute shall be resolved during the CollaborationTerm as follows. For the avoidance of doubt, the right of a Party to make final decisions with respect to any issue shall not otherwise diminish or eliminate such Party’s obligations underthis Agreement, including its obligation to exercise Commercially Reasonable Efforts whererequired herein.

 

(A)Ultragenyx will have final decision making authorityover [***];

 

(B)The Parties must mutually agree on the scope ofResearch SupporttobeprovidedbyTakeda.IfthePartiesareunabletounanimouslyagreeonthe scope of the Research Support to be provided, then no Research Support shall beprovided;

 

(C)Takeda will have final decision making authority over[***];and

 

(D)Neither Party shall have the final decision making authority for anyothermatterunderthepurviewoftheJRCandnotcoveredbysubsections(A)-(C),and the status quo shall persist with respect to such matter if the Parties are unable to agree.For clarity,thePartiesanticipatethatLicensedOptionProductswillbegovernedbyaseparate committee and final decision making authority to be established pursuant to theOption Product LicenseAgreement.

 

|   | 2.3 | Committee Membership andProcedures. |   |
|--------|-----|-------------------------------------|--------|

 

(a)Membership. Takeda and Ultragenyx shall each designate an equal numberof representatives to serve on the JSC and the JRC (each, a “Committee”) by written notices tothe other Party. Promptly after the Effective Date, each Party shall designate three(3)

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representatives for the JSC and three (3) representatives for the JRC. Each Committee mayelect tovarythenumberofrepresentativesfromtimetotimeduringtheTerm;providedthateach Committee shall maintain an equal number of representatives from each Party.Each representative shall have the appropriate level of experience in the subject area of the Committee, and at least one (1) representative shall have sufficient seniority withinthe applicable Party’s organization to have the necessary decision-making authority in order forthe Committee to fulfill its responsibilities. Either Party may designate substitutes for itsCommittee representatives if one (1) or more of such Party’s designated representatives is unable tobe present at a meeting. From time to time each Party may replace its Committee representativesby written notice to the other Party specifying the prior representative(s) and theirreplacement(s).

 

(b)Chairperson.EachCommitteewillhavetwochairpersons,onedesignatedby eachoftheParties.Thechairpersonsshallberesponsibleforcallingandconveningmeetings, butshallhavenospecialauthorityovertheothermembersoftheCommittee,andshallhaveno additional voting rights. The chairpersons (or their designates) shall jointly: (i) prepareand circulate an agenda reasonably in advance of each upcoming meeting; and (ii) prepare andissue minutes of each Committee meeting within thirty (30) days thereafter. Such minutes shall notbe finalizeduntileachCommitteerepresentativereviewsandapprovessuchminutesinwriting; provided that any minutes shall be deemed approved unless a member of such Committeeobjects to the accuracy of such minutes within fifteen (15) days after the circulation of theminutes.

 

|   | (c) | Meetings. |   |
|--------|-----|-----------|--------|

 

(i)CommitteeMeetings.EachCommitteeshallmeetatleastonceeach Calendar Quarter. Additional meetings of the Committees may be held with the consent ofeach Party (such consent not to be unreasonably withheld, conditioned or delayed), as requiredunder thisAgreement.InthecaseofanydisputereferredtoaCommittee,suchmeetingshallbeheld withinfive(5)BusinessDaysfollowingreferraltotheCommittee,orassoonasreasonably possible.

 

(ii)General Requirements. Meetings of a Committee shall be effectiveonly if a majority of representatives of each Party are present or participating. Other than theinitial meeting,whichshallbeheldinperson,aCommitteemaymeeteither(A)inpersonateither Party’s facilities or at such locations as the Parties may otherwise agree; or (B) by audio orvideo teleconference. Additional non-members of a Committee having relevant experience mayfrom timetotimebeinvitedtoparticipateinaCommitteemeeting,providedthatsuchparticipants shall have no voting rights or powers. Non-member participants who are not employees ofa Party or its Affiliates shall only be allowed to attend if: (i) the other Party’s representativeshave consented to the attendance (such consent not to be unreasonably withheld, conditionedor delayed); and (ii) such non-member participant is subject to confidentiality andnon-use obligations at least as restrictive as those set forth in this Agreement. Each Party shallbe responsible for all of its own expenses incurred in connection with participating inthe Committeesincludingalltravelandallexpensesassociatedwithaninitialalliancekick-off meeting.AllotherexpensesincurredbyaCommitteeinfurtheranceofameeting,suchas expenses associated with off-site meetings, shall be shared equally by theParties.

 

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2.4Alliance Managers.  Promptly following the Effective Date, each Party shall designate in writing an Alliance Manager to serve as the primary point of contact for the Partiesregarding all collaboration and transition activities contemplated under this Agreement. EachAlliance ManagershallfacilitatecommunicationandcoordinationoftheParties’activitiesunderthis Agreement relating to the Products and shall plan the Committee meetings. TheAlliance Managers shall be allowed to attend Committee meetings as non-votingobservers.

 

2.5Authority. The Parties agree that, in voting on matters as described in this ARTICLE 2, it shall be conclusively presumed that unless otherwise explicitly stated, each voting member of a Committee has the authority and approval of such member’s respective senior managementin castinghisorhervote.EachCommitteeshallhaveonlythepowersassignedexpresslytoitin thisARTICLE2andelsewhereinthisAgreement,andshallnothaveanypowertoamend, modify or waive compliance with thisAgreement.

 

2.6Takeda Secondee. Takeda shall have the right, at its own expense, to place one employee of Takeda or its Affiliates, who is reasonably acceptable to Ultragenyx, as asecondee withUltragenyxatanytimeduringtheCollaborationTerm;providedthatsuchsecondeeshall enter into a confidentiality agreement with Ultragenyx prior to placement. Takeda may, oneor moretimesduringtheCollaborationTerm,substitutesuchemployeewithanotheremployeeof Takeda or itsAffiliates.

 

ARTICLE 3  – LICENSES FOR [***] ANDANALOGS

 

3.1Licenses from Takeda to Ultragenyx. Subject to the terms and conditions ofthis Agreement, Takeda hereby grants to Ultragenyx in the Territory during theTerm:

 

(a)an exclusive (even as to Takeda and its Affiliates, subject to the retention ofrights to conduct activities under the [***] Development Plan) license, with the right to grantsublicenses solelyinaccordancewithSection3.3,undertheLicensed[***]Technology,LicensedProduct ImprovementsControlledbyTakedaoritsAffiliates,LicensedProductImprovementPatents Controlled by Takeda or its Affiliates, and Joint Intellectual Property to Exploit the Licensed[***] Products in the UltragenyxField;

 

(b)a co-exclusive license, without the right to grant sublicenses, under theLicensed

[***] Technology, Licensed Product Improvements Controlled by Takeda or itsAffiliates, Licensed Product Improvement Patents Controlled by Takeda or its Affiliates, andJoint Intellectual Property to conduct activities under the [***] Development Plan in the Takeda Fieldin the Territory;and

 

(c)anexclusive(evenastoTakedaanditsAffiliates)license,includingtherightto grantsublicensessolelyinaccordancewithSection3.3,undertheLicensed[***]Technology, Licensed Product Improvements Controlled by Takeda or its Affiliates, LicensedProduct Improvement Patents Controlled by Takeda or its Affiliates, and Joint Intellectual Propertyto Exploit the Licensed Analog Compounds and Licensed Analog Products in the Licensed Fieldin the Territory; provided, however, that, notwithstanding the licenses granted in this Section 3.1(c),atanytimeduringtheTermUltragenyxshallnot,andshallcauseitsAffiliatesnotto(i)

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directlyorindirectlyExploitanyLicensedAnalogProductintheTakedaFieldor(ii)license, authorize,appoint,orotherwiseenableanyThirdPartyto,directlyorindirectly,Exploitany Licensed Analog Product in the TakedaField.

 

3.2Licenses from Ultragenyx to Takeda. Subject to the terms and conditions ofthis Agreement, Ultragenyx hereby grants to Takeda in the Territory during theTerm:

 

(a)anexclusive(evenastoUltragenyxanditsAffiliates,subjecttotheretentionof rightstoconductactivitiesunderthe[***]DevelopmentPlan)license,withtherighttogrant sublicenses under multiple tiers solely in accordance with Section 3.3, under the Ultragenyx[***] Technology, Licensed Product Improvements Controlled by Ultragenyx or itsAffiliates, Licensed Product Improvement Patents Controlled by Ultragenyx or its Affiliates, andJoint Intellectual Property to (i) Exploit the Licensed [***] Products in the Takeda Field inthe Territory,and(ii)ExploitanystructuresCoveredbytheLicensed[***]Patent,otherthanwith respect to Licensed Analog Compounds, in the Takeda Field in theTerritory.

 

(b)a co-exclusive license, without the right to grant sublicenses,  underthe Ultragenyx[***]Technology,LicensedProductImprovementsControlledbyUltragenyxorits Affiliates, Licensed Product Improvement Patents Controlled by Ultragenyx or its Affiliates,and Joint Intellectual Property to conduct activities under the [***] Development Plan inthe Ultragenyx Field in the Territory and to perform the activities under the [***] DevelopmentPlan.

 

3.3Sublicensing. Each Party shall have the right to grant sublicenses, through multipletiers, oftherightsgrantedtosuchPartyunderSections3.1(a)and3.1(c)(inthecaseofUltragenyx) andSection3.2(a)(inthecaseofTakeda),toitsAffiliatesandtoThirdParties;provided, howeverthat(a)subjecttoSection5.2,Ultragenyxshallnotgrantasublicenseoftherights granted to it under (i) Section 3.1(a) to a Third Party without the prior written consent ofTakeda (not to be unreasonably withheld, conditioned or delayed) or (ii) Section 3.1(c) in theTakeda Fieldand(b)TakedashallnotgrantasublicenseoftherightsgrantedtoitunderSection3.2(a) to a Third Party without the prior written consent of Ultragenyx (not to be unreasonably withheld,conditionedordelayed).Eachsublicenseshallrefertoandbesubordinatetothis Agreementand,excepttotheextentthePartiesotherwiseagreeinwriting,anysublicensemust be consistent in all material respects with the terms and conditions of this Agreement.Upon terminationofthisAgreement,anysublicensegrantedbyUltragenyxtoaThirdPartyshall continueandbetransferredtoTakedaandanysublicensegrantedbyTakedatoaThirdParty shall continue and be transferred to Ultragenyx; provided that such sublicenses comply withthe requirements of this Section 3.3. Each Party shall remain responsible for the performance ofthis Agreement and the performance of its sublicensees hereunder.

 

3.4No Implied Licenses. No license or other right is or shall be created or grantedhereunder byimplication,estoppel,orotherwise.Alllicensesandrightsareorshallbegrantedonlyas expresslyprovidedinthisAgreement.AllrightsnotexpresslygrantedbyaPartyunderthis Agreement are reserved by the Party and may not be used by the other Party for anypurpose.

 

 

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ARTICLE 4  – LICENSED PRODUCTDEVELOPMENT

 

4.1Overview of Product Development. The Parties desire and intend to collaboratewith respect to the Development of the Licensed Product in the Licensed Field in the Territory, tothe extent set forth in this Agreement. Takeda’s Development of the Licensed [***] Products inthe TakedaFieldandUltragenyx’sDevelopmentoftheLicensed[***]ProductsintheUltragenyx FieldandLicensedAnalogProductsintheLicensedFieldshallbeconductedinamanner consistent with the [***] Development Plans and using Commercially ReasonableEfforts.

 

|   | 4.2 | Transition and Exchange of Know-How |
|--------|-----|-------------------------------------|

 

(a)Transition from Takeda to Ultragenyx. As soon as practicable afterthe EffectiveDate,thePartieswillcooperateandactingoodfaithtosupportthetransitionofthe Licensed [***] Product from Takeda to Ultragenyx in the Ultragenyx Field and, solelyfor purposesofUltragenyx’sperformanceofitsobligationsunderSection4.3(a)(ii),intheTakeda Field,atnoadditionalconsiderationpayabletoTakeda,includingthe(i)transitionand,tothe extent appropriate, assignment of Regulatory Materials and Regulatory Approvals coveringthe Licensed [***] Product in the Ultragenyx Field and, solely for purposes ofUltragenyx’s performanceofitsobligationsunderSection4.3(a)(ii),intheTakedaField,fromTakedato Ultragenyx, (ii) sharing of the Licensed [***] Know-How with Ultragenyx to the extentnecessary orreasonablyusefulfortheuseoftheLicensed[***]ProductandtheLicensedAnalogProducts for and implementation of the Initial [***] Development Plan, and (iii) transferring toUltragenyx, at no cost to Ultragenyx, those biological materials or chemical compounds related tothe Licensed[***]ProductControlledbyTakedaasoftheExecutionDateasarenecessaryfor Ultragenyx to perform the activities allocated to it under the Initial [***] DevelopmentPlan. Takeda will also use Commercially Reasonable Efforts, at Ultragenyx’s sole cost and expense,to assignorsublicensetoUltragenyxanyexistingThirdPartyagreementsthatarenecessaryor reasonablyusefulfortheExploitationofaLicensed[***]ProductintheUltragenyxFieldinthe Territory.Withinforty-five(45)daysafterthereceiptofaninvoicefromTakedareflectingthe costs and expenses of such assignment or sublicense, Ultragenyx shall pay the invoicedamounts toTakeda.

 

(b)Know-How Sharing by Ultragenyx. Ultragenyx shall provide toTakeda, promptly after the Effective Date and during the Term upon Ultragenyx Know-Howbeing obtained or generated by Ultragenyx, at no additional cost or expense to Takeda, allsuch Ultragenyx Know-How as is necessary or reasonably useful to enable Takeda: (a) to performits obligationsunderthisAgreement;(b)toExploittheLicensed[***]ProductintheTakedaField, and (c) to Exploit any structures Covered by the Licensed [***] Patent, other than with respectto Licensed Analog Compounds, in the Takeda Field in theTerritory.

 

|   | 4.3 | DevelopmentActivities. |
|--------|-----|------------------------|

 

(a)Throughout the Term, Ultragenyx will use Commercially Reasonable Effortsto

(i)ExploitaLicensed[***]ProductorLicensedAnalogProductintheUltragenyxFieldinthe Territory and  (ii) complete Development  activities  for a  Licensed [***]  Product  in  theTakeda

 

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Field,ineachcaseatUltragenyx’ssoleexpenseandpursuanttotheInitial[***]Development Plan.

 

(b)If the Parties mutually agree to conduct other Development activities withrespect toaLicensed[***]ProductotherthanassetforthintheInitial[***]DevelopmentPlan,thenthe Parties shall prepare a plan (including timeline and budget) covering the Developmentactivities tobecompleted,thePartyresponsibleforcompletingsuchactivities,andthePartyresponsible for the associated costs (together with the Initial [***] Development Plan, the “[***]DevelopmentPlans”).

 

(c)If Ultragenyx elects to pursue Development of a Licensed AnalogProduct, Ultragenyx will use Commercially Reasonable Efforts to Exploit such Licensed AnalogProduct intheUltragenyxFieldintheTerritoryatUltragenyx’ssoleexpenseandpursuanttoa[***] Development Plan for such Licensed Analog Product.

 

(d)At Ultragenyx’s sole expense, Takeda, using Commercially ReasonableEfforts, will (i) conduct initial manufacturing process development and scale-up activities forthe LicensedProductsassetforthintheInitial[***]DevelopmentPlanandinaccordancewiththe agreeduponbudgetcontainedtherein,(ii)willworkwithUltragenyxtotransferLicensed[***] Know-How as necessary or reasonably useful for Development and for the purposesof completing Regulatory Applications, initiating Clinical Trials and for transitioning manufacturing activities to Ultragenyx, and (iii) conduct such other Developmentand Manufacturing activities as may be mutually agreed by theParties.

 

(e)EachPartyshallconductitsactivitiesunderthisAgreementingoodscientific mannerandincomplianceinallmaterialrespectswithallApplicableLaws,including,GCP, GLP, andGMP.

 

(f)If Ultragenyx breaches its obligations under Section 4.3(a) or 4.3(c) oris otherwise no longer actively conducting Development of a Licensed [***] Compoundand Licensed [***] Product in any indication in the Ultragenyx Field, then [***] of the date Ultragenyx stopped actively conducting such Development,the Ultragenyx [***] License for the Licensed [***] Compound and Licensed [***] Productshall terminate and, [***] of such event, such license shall revert toTakeda and the terms of Section 15.7(c) shall apply with respect to such Compound andProduct; provided, that, upon the reversion of rights to Takeda, Takeda shall not develop such Productin the Ultragenyx Field except in accordance with Takeda’s exercise of the Takeda Option orright offirstnegotiationpursuanttoARTICLE8.If,priortotheeffectivedateofsuchreversion, UltragenyxdeterminesitwishestolicensesuchCompoundorProductfromTakedainthe Ultragenyx Field, Ultragenyx may provide written notice to Takeda. Following receipt ofsuch notice, Takeda and Ultragenyx will negotiate in good faith such license agreement for a periodof [***] thereafter, which period may be extended by mutual agreement. Anyresulting licenseagreementwillbesubjecttoTakeda’sexerciseoftheTakedaOptionorrightoffirst negotiation pursuant to ARTICLE8.

 

 

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(g)Neither Party may Develop Licensed [***] Products in the Ultragenyx Fieldexcept assetforthinthe[***]DevelopmentPlan.TakedashallhavethesolediscretiontoDevelop Licensed [***] Products in the TakedaField.

 

|   | 4.4 | Clinical Trial Registry. |
|--------|-----|--------------------------|

 

(a)Ultragenyx shall be responsible for registering any Clinical Trialperformed pursuanttothe[***]DevelopmentPlansintheappropriateclinicaltrialregistry(e.g., clinicaltrials.gov) and posting the results of such Clinical Trials as required by ApplicableLaws.

 

(b)The posting of any results to a clinical trial registry in accordance  withthis Section 4.4 shall be considered a “publication” and subject to the Parties’ obligations set forthin Section 14.9.

 

4.5Records; Disclosure of Data and Results. In conformity with standardpharmaceutical industrypracticesandthetermsandconditionsofthisAgreement,eachPartyshallprepareand maintain,orshallcausetobepreparedandmaintained,completeandaccuratewrittenrecords, accounts, notes, reports and data with respect to activities conducted pursuant to the[***] DevelopmentPlansforaminimumofthree(3)yearsfollowingtheendoftheCalendarYearto which they pertain (or such longer period as may be required by Applicable Laws) and, uponthe otherParty’sreasonablewrittenrequest,shallsendlegiblecopies(inEnglishandinelectronic format)oftheaforesaidtotheotherParty,totheextentnotalreadyprovided,throughoutthe Term and for a minimum of twelve (12) months following the Term. Upon reasonableadvance notice, at the request of the JSC, each Party agrees to make its employees andconsultants reasonablyavailableattheirrespectiveplacesofemploymenttoconsultwiththeotherPartyon issues arising in connection with the [***] Development Plans. In accordance with thereporting formatandscheduleapprovedbytheJSC,eachPartyshallpromptlyandfullydisclosetothe other Party in writing all data, including preclinical data, Clinical Trial data, formulation data andmanufacturingdata,generatedbyoronbehalfofsuchPartywithrespecttotheProductsin theLicensedField.Withoutlimitingtheforegoing:(a)UltragenyxshallkeepTakedaregularly andfullyinformedbyreportingtotheJSConaquarterlybasisregardingtheDevelopmentof LicensedProductsintheUltragenyxFieldintheTerritorybyUltragenyx,itsAffiliatesand sublicensees,includinginformationregardingthestatusofClinicalTrials,filingofRegulatory MaterialsandreceiptofRegulatoryApprovalwithrespecttotheProductsintheUltragenyx Field in the Territory; (b) on at least an annual basis (but in any event, no later than December1 of each Calendar Year), each Party, as applicable, shall submit to the JSC proposed updatesand amendments, as appropriate, to the [***] Development Plans; and (c) Takeda shallkeep Ultragenyx regularly informed by reporting to the JSC on a quarterly basis regardingthe Development of Licensed Products in the Takeda Field by Takeda, its  Affiliates and sublicensees, including information regarding the status of any Clinical Trials, filingof RegulatoryMaterialsandreceiptofRegulatoryApprovalwithrespecttotheProductsinthe Takeda Field in theTerritory.

 

ARTICLE 5– [***] CO-DEVELOPMENT ANDCO-COMMERCIALIZATION

 

5.1Co-Development and Co-Commercialization Negotiation for TakedaField.

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(a)Assoonaspracticable,butnolaterthan[***],UltragenyxshalldelivertoTakedatheFinal [***]DataPackageforsuchLicensedProduct.Foraperiodof[***]followingthe deadlinefordeliveryofsuchFinal[***]DataPackageforthefirstLicensed[***]Productor Takeda’searlierreceiptofsuchFinal[***]DataPackage(the“[***]OptionTerm”),Ultragenyx will have the right to exercise an exclusive option to co-Develop and co-Commercializethe Licensed [***] Products in the Takeda Field in the Territory (the “[***] Option”). Upon exerciseof the [***] Option prior to the expiration of the [***] Option Term, the Parties will negotiate ingood faith, for a period of up to [***] (the “[***] LicenseNegotiationPeriod”),thetermsrelatingtotheco-Developmentandco-CommercializationoftheLicensed [***]ProductsintheTakedaFieldintheTerritory(otherthantherightsregardingfinaldecision making authority of the Parties, which will be as set forth in Section2.1(b)(ii)(D)).

 

(b)If Ultragenyx exercises the [***] Option within the [***] Option Term  andthe Parties reach agreement regarding the co-Development and co-Commercialization ofthe Licensed [***] Product in the Takeda Field within the [***] License Negotiation Period,such agreement,includinganyneededmodificationtotheUltragenyx[***]LicenseandTakeda[***] License,willbeenteredintobythePartiesortheirdesignatedAffiliates.Suchagreementshall provide that, if Ultragenyx terminates the Development of Licensed [***] Products inthe Ultragenyx Field, then Ultragenyx shall have the right to terminate such co-Development and co- CommercializationofLicensed[***]ProductsintheTakedaFielduponprovidingTakedawith thefollowingpriorwrittennotice:(i)iftheLicensed[***]ProductisinDevelopmentatthetime of termination, [***], and (ii) if the Licensed [***] Product is being Commercializedat the time of termination, [***].

 

(c)If Ultragenyx exercises the [***] Option within the [***] Option Term  andthe Partiesfailtoreachanagreementregardingtheco-Developmentandco-Commercializationof theLicensed[***]ProductintheTakedaFieldwithinthe[***]LicenseNegotiationPeriod,then Takeda and Ultragenyx shall have the right to submit their proposed terms for suchco- Development and co-Commercialization of the Licensed [***] Products in the Takeda Field inthe TerritorytobindingarbitrationassetforthinSection16.3;provided,however,thattherights regardingthefinaldecisionmakingauthorityofthePartiesassetforthinSection2.1(b)(ii)(D) will not be subject to modification in sucharbitration.

 

5.2Takeda Right of First Negotiation for the Ultragenyx Field.Notwithstanding Ultragenyx’srighttosublicenseunderSection3.3,Ultragenyxdoesnothavetherighttoenter into an agreement with any Third Party for the co-Development and/orco-Commercialization (including co-promotion) of the Licensed Product in the Ultragenyx Field except inaccordance with the terms of this Section 5.2. If Ultragenyx intends to co-Develop and/orco-Commercialize (including co-promote) with a Third Party a Licensed Product in the UltragenyxField, UltragenyxwillprovideTakedawithpriorwrittennoticeofsuchintentand,foraperiodof[***] after receipt of such notice, Takeda will have a right offirst negotiation to enter into a definitive agreement with Ultragenyx for such co-Developmentand/or co-Commercialization(includingco-promotion).IfthePartiesfailtoenterintoadefinitive

 

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agreementpriortotheexpirationof[***],Ultragenyxwill have the right to enter into a definitive agreement with a Third Party (including viasublicensing as set forth in Section 3.3) for the co-Development and/or co-Commercialization (includingco- promotion)oftheLicensedProductintheUltragenyxField;provided,that,[***], Ultragenyx shallnot enter into such a definitive agreement with a Third Party on terms, when viewed as a whole,that are less favorable to Ultragenyx than the terms last offered to Ultragenyx byTakeda.

 

5.3Commercialization Plans. Each Party shall submit a Commercialization Plan to theJSC fordiscussionnoless[***]priortotheanticipateddateofsuchPartyobtaining Regulatory Approval for a Licensed Product. Thereafter, each Party shall provide a copy ofthe then-currentCommercializationPlantotheJSCatleastonceeachCalendarYearduringthe Licensed Product Royalty Term and Takeda Royalty Term, asapplicable.

 

|   | 5.4 | Commercialization Activities. |
|--------|-----|-------------------------------|

 

(a)Ultragenyx Commercialization. Ultragenyx shall use CommerciallyReasonable Efforts to Commercialize the Licensed Product in the Ultragenyx Field in theTerritory throughouttheTerm.Subjecttoanymodificationsbasedonagreementsreachedpursuantto Sections 5.1 and 5.2, Ultragenyx’s Commercially Reasonable Efforts requirements andthe provisions of Section 2.1(b), Ultragenyx has sole discretion relating to all aspects ofthe CommercializationofLicensedProductsintheUltragenyxFieldintheTerritory.Asbetween theParties,Ultragenyxshallbearallofthecostsandexpensesincurredinconnectionwithall such Commercialization activities. On an annual basis, and no later than March 1 ofeach Calendar Year following the First Commercial Sale of a Licensed Product in the  Ultragenyx FieldintheTerritory,UltragenyxshallpresentareasonablydetailedwrittenreporttotheJSC summarizing Ultragenyx’s overall Commercialization activities undertaken during theprevious Calendar Year with respect to the Licensed Products in the UltragenyxField.

 

(b)Takeda Commercialization. Subject to any modifications based onagreements reachedpursuanttoSections5.1and5.2andtheprovisionsofSection2.1(b),Takedahassole discretion relating to the Commercialization of Licensed [***] Products in the Takeda Field inthe Territory.AsbetweentheParties,Takedashallbearallofthecostsandexpensesincurredin connection with all such Commercializationactivities.

 

|   | 5.5 | Trademarks. |
|--------|-----|-------------|

 

(a)Ownership. Each Party shall own, throughout the world, each Producttrademark that it develops for a Product in its Field in the Territory (each a “Product Trademark”).All goodwillattributabletoaParty’sProductTrademarkgeneratedbytheCommercializationofa Product bearing such mark shall inure to the benefit of suchParty.

 

(b)Use. Neither Party shall be obligated to use the other Party’s ProductTrademark orHouseMarksexcepttotheextentrequiredbyApplicableLaworregulatoryrequirement. NeitherPartyshall,duringtheTermorthereafter,adopt,registeroruseanytrademark,trade

 

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name,brandname,symbolorlogothatisidentical,orconfusinglysimilar,totheotherParty’s ProductTrademarks.

 

(c)Filing; Maintenance. Each Party shall solely be responsible for, and shallsolely bear all costs associated with maintenance and enforcement of, such Party’s ProductTrademark.

 

ARTICLE 6  – RESEARCH COLLABORATION

 

6.1 Research Collaboration Generally. The Parties will conduct research of Takeda’s[***] Compound and Candidate Products as set forth in this Agreement. As further describedbelow, the Candidate Products will be selected from the Takeda-Controlled compounds listed onExhibit

6.1attachedhereto,asmaybeamendedfromtimetotimebyTakedainitssolediscretion(the “ListedCompounds”).

 

|   | 6.2 | Nomination of Candidate Products and ValidationResearch. |   |
|--------|-----|----------------------------------------------------------|--------|

 

(a)Nomination. Either Party may nominate compounds from the ListedCompounds for consideration and approval by the JRC as candidate products under this Agreement(upon such approval, each such Listed Compound shall thereafter be a “Candidate Product”). TheJRC may select up to five (5) Candidate Products for validation pursuant to Section 6.2(b) at anyone time.If five (5)CandidateProductshavebeenselectedatanyonetime,neitherPartymay nominateanyadditionalListedCompoundtobeconsideredasaCandidateProductunlessand untilthePartiesdetermine,afterthecompletionorterminationofresearchactivitiesunderthe applicableValidationResearchPlan,thataCandidateProductwillnotbenominatedasan Option Product.

 

(b)Validation Research Plan. Takeda will design, with input from Ultragenyx,a research plan and budget for the initial validation for each Candidate Product (each,a “ValidationResearchPlan”),witheachsuchValidationResearchPlanintendedtosufficiently include the activities required to provide information and data necessary for the JRC to determinewhethertonominateaCandidateProductasanOptionProduct.EachValidation ResearchPlanwillbesubmittedtotheJRCforapproval(forwhichTakedawillhavefinal decision-making authority in accordance with Section 2(c)(ii)(C)) and will be funded byTakeda and performed by or on behalf of Takeda, in Takeda’s solediscretion.

 

|   | 6.3 | [***] Research Plan and Transition |   |
|--------|-----|------------------------------------|--------|

 

(a)DuringtheCollaborationTermwithrespecttothe[***]Products,thePartieswill use Commercially Reasonable Efforts to Exploit the [***] Products, at Ultragenyx’s soleexpense, pursuanttotheinitialresearchplanandbudgetforthe[***]ProductsattachedheretoasExhibit6.3(a) (the “[***] Research Plan”). Pursuant to the [***] Research Plan and in accordance withthe associated budget, at Ultragenyx’s sole expense, Takeda will use CommerciallyReasonable Efforts to conduct initial Manufacturing process development and scale-up of the [***]Products, asagreedbytheParties.Forclarity,therewillnotbeanyValidationResearchPlanforthe[***] Products.

 

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(b)During the Collaboration Term with respect to the [***] Products, the Partiesshall cooperateandactingoodfaithtosupportthetransitionofthe[***]ProductsfromTakedato UltragenyxintheLicensedFieldtotheextentnecessaryorreasonablyusefulforUltragenyxto performthe[***]ResearchPlan,includingthetransitionofOptionProductKnow-Howwith respect to the [***] Products. [***].

 

6.4Option Product Research Plan. During the Collaboration Term with respect toeach Option Product for which there is an agreed Option Product Research Plan, Ultragenyx willuse Commercially Reasonable Efforts to Exploit each Option Product in accordance withthe applicable Option Product ResearchPlan.

 

|   | 6.5 | Limited Licenses During the CollaborationTerm. |
|--------|-----|------------------------------------------------|

 

(a)License toUltragenyx.

 

(i)UponselectionofaCandidateProductasanOptionProductbytheJRC and as of the Effective Date with respect to [***] Products, Takeda hereby grants to Ultragenyxa limited, co-exclusive (with Takeda and its Affiliates), non-transferable,non-sublicensable, royalty-free license under the Option Product Technology, Option ProductImprovements Controlled by Takeda or its Affiliates, Option Product Improvement Patents Controlledby TakedaoritsAffiliates,andJointIntellectualPropertytoExploittheOptionProductsolelyin accordance with the activities to be performed by Ultragenyx under the Option ProductResearch Plan.

 

(ii)TheforegoinglicenseunderSection6.5(a)(i)willcontinueonanOption Product-by-Option Product basis until the earlier of (A) execution of an Option ProductLicense Agreement, (B) failure by the Parties to enter into an Option Product License Agreement bythe expirationoftheapplicableOptionNegotiationPeriod,or(C)expirationorterminationofthe CollaborationTerm,atwhichtimesuchOptionProductshallbeaTerminatedProductandall rights to such Option Product will revert to Takeda in accordance with Section 15.7(c);provided that, if in the case of (C), an Option Negotiation Period is then ongoing, the CollaborationTerm withrespecttosuchOptionProductwillautomaticallyextenduntiltheearlierof(1)expiration ofsuchOptionNegotiationPeriodor(2)executionoftheapplicableOptionProductLicense Agreement.

 

(b)License to Takeda. During the Collaboration Term, with respect toeach Research Product, Ultragenyx hereby grants to Takeda a limited, non-exclusive,non- transferable, non-sublicensable, royalty-free license, under all Ultragenyx IntellectualProperty, OptionProductImprovementsControlledbyUltragenyxandJointIntellectualPropertyforuse in the Licensed Field in the Territory solely to perform its obligations under each ResearchPlan and to the extent necessary or reasonably useful for Takeda to evaluate a CandidateProduct.

 

(c)NoImpliedLicenses.Nolicenseorotherrightisorshallbecreatedorgranted hereunderduringtheCollaborationTermwithrespecttoanyResearchProductbyimplication,

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estoppel,orotherwise.AllrightsnotexpresslygrantedbyaPartyunderthisAgreementare reserved by such Party and may not be used by the other Party for anypurpose.

 

|   | 6.6 | Research Materials Transfer. |   |
|--------|-----|------------------------------|--------|

 

(a)In order to facilitate the activities contemplated by this Agreement, Takedashall transfer to Ultragenyx, at no cost to Ultragenyx (i) those quantities of [***] CompoundControlled byTakedaasoftheExecutionDateasarenecessaryforUltragenyxtoperformtheactivities allocated to it under the [***] Research Plan and (ii) reasonable quantities of biologicalmaterials orchemicalcompoundsControlledbyTakedaatthetimeaCandidateProductbecomesan Option Product for Development of such Option Product (collectively, the “ResearchMaterials”) by Ultragenyx in furtherance of the applicable Research Plans. Such transfer shall be pursuantto a mutually agreed upon Research Materials transfer plan and schedule (including, as necessary,a separate agreement with respect to such transfer which the Parties shall enter as soonas practicable(A)aftertheEffectiveDateinthecaseoftheforegoingclause(i)or(B)aftera Candidate Product becomes an Option Product in the case of the foregoing clause (ii)). Except as otherwise provided for under this Agreement, all such Research Materials will remain thesole propertyofTakeda,willbeusedonlyinfurtheranceoftheactivitiesconductedinaccordance withtheapplicableResearchPlans,willnotbeusedordeliveredtoorforthebenefitofany ThirdParty(exceptforsubcontractorsinfurtheranceoftheResearchPlans),withouttheprior written consent of Takeda, and will be used in compliance with Applicable Law. TheResearch Materials supplied under this Agreement must be used with prudence and appropriate cautionin any experimental work because not all of their characteristics may be known.  Takedawill provideUltragenyxthemostcurrentmaterialsafetydatasheetfortheResearchMaterialsupon transfer of any ResearchMaterials.

 

(b)Except as expressly set forth in this Agreement, THE RESEARCHMATERIALS AREPROVIDED“ASIS”ANDWITHOUTANYREPRESENTATIONORWARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTYOF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE ORANY WARRANTY THAT THE USE OF THE RESEARCH MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANYTHIRD PARTY.

 

|   | 6.7 | General Terms Applicable to Research Plans and ResearchActivities. |   |
|--------|-----|--------------------------------------------------------------------|--------|

 

(a)Annual Review of Research Plans. On an annual basis, the Parties, throughthe JRC, shall review, and as necessary, update and amend the then-current Research Plans, provided that either Party may at any time between annual updates recommend updatesor amendments of the then-current plans and associated budget for consideration by theJRC.

 

(b)Performance Obligations. With respect to each Research Plan, Ultragenyxand Takeda shall each use Commercially Reasonable Efforts to execute and perform theactivities assigned to it and cooperate with the other Party in the performance of such activities. Each PartyshallconducttheactivitiesassignedtoitundertheResearchPlaninagoodscientific mannerandincomplianceinallmaterialrespectswithApplicableLaw,includingapplicable

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national and international (e.g., ICH, GCP, GLP, and GMP) guidelines. If a ResearchPlan providesforClinicalTrials,thesponsorofsuchtrialshallregisterandposttheresultsofsuch trial.

 

(c)Records; Disclosure of Data and Results. Each Party shall prepare and maintain,orshallcausetobepreparedandmaintained,completeandaccuratewrittenrecords, accounts,notes,reportsanddatawithrespecttoitsactivitiesconductedpursuanttoaResearch Plan in conformity with Applicable Law and standard pharmaceutical industrypractices; providedthatinnocaseshallsuchrecordsbemaintainedforlessthanthree(3)yearsfollowing theCalendarYeartowhichsuchrecordspertain(orsuchlongerperiodasmayberequiredby Applicable Laws). Upon the other Party’s written request, the Party receiving suchwritten request shall send legible copies of the aforesaid to the other Party throughout the Termwith respect to such Research Product and for a minimum of twelve (12) months followingsuch Term. Upon reasonable advance notice, at the request of the JRC, each Party agrees to makeits employees and consultants reasonably available at their respective places of employmentto consult with the other Party on issues arising in connection with each Research Plan.In accordance with the reporting format and schedule approved by the JRC, each Partyshall promptlydisclosetotheotherPartyinwritingalldata,includingpreclinicaldata,clinicaltrial data(ifany),formulationdataandManufacturingdata,generatedbyoronbehalfofsuchParty with respect to a Research Product in the Licensed Field in theTerritory.

 

(d)Termination of Research Plan. In the event the activities under a ResearchPlan areterminatedforanyreason,allresearchthereundershallceaseandtheapplicableOption Productor[***]ProductwillbedeemedtobeaTerminatedProduct.AllTerminatedProducts shall revert to Takeda pursuant to Section 15.7(c). For clarity, such termination shallnot terminate the Collaboration Term for any other purpose under thisAgreement.

 

|   | 6.8 | Research ProgramExpenses. |
|--------|-----|---------------------------|

 

(a)Nomination Evaluation. Each Party shall be responsible for its own FTEs and anyThirdPartyexpenses,ineachcase,incurredwithrespecttothenomination,evaluationand selection of Candidate Products in accordance with Section6.2(a).

 

(b)[***] Research Plan. Ultragenyx shall reimburse Takeda for Takeda’s FTECosts andout-of-pocketThirdPartyexpenses,ineachcase,incurredbyTakedainfurtheranceofthe completion of those activities assigned to it under the [***] Research Plan and in accordancewith the applicable budget, subject to a maximum reimbursement obligation of [***] of such budget or such greater amount as Ultragenyx may approve inadvance.

 

(c)Validation Research Plan. Takeda shall be responsible for its own FTEs andany Third Party expenses incurred by Takeda with respect to a Validation ResearchPlan.

 

(d)Option Product Research Plan. Ultragenyx shall reimburse Takeda for Takeda’s FTE Costs and out-of-pocket Third Party expenses, in each case, incurred by Takedain furtherance of the completion of those activities assigned to it under an Option ProductResearch Plan and in accordance with the applicable budget, subject to a maximumreimbursement

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obligation of [***] of such budget or such greater amountas Ultragenyx may approve inadvance.

 

6.9Invoices. Within forty-five (45) days after the end of each Calendar Quarter, Takedawill provide a written report and invoice to Ultragenyx setting forth in reasonable detail its FTEsand itsThirdPartyexpensesrecordedinfurtherancethe[***]ResearchPlanandOptionProduct Research Plans. Within sixty (60) days after the receipt of such invoice, Ultragenyx shall paythe undisputedportionofanysuchinvoice.Forclarity,makingsuchapaymentdoesnotpreempt Ultragenyx’s audit rights under Section 11.12, which remain in full force and effect.If Ultragenyx in good faith identifies items in an invoice which are disputed, Ultragenyx willnotify Takedainwriting,notingitsobjectiontothedisputeditem(s)withspecificity,withinten(10) business days of receipt of the invoice. Takeda will respond to such written notificationwithin ten (10) days of receipt of the disputed notification. Thereafter, the Parties shall negotiate in good faith to resolve the dispute with either Takeda supplying Ultragenyxdocumentation justifyingthechargeorreducingordeletingthedisputedamount.Anydisputeoverinvoiced amounts due that cannot be resolved by direct good faith negotiation between the Parties shallbe resolvedinaccordancewithARTICLE16(DisputeResolution)ofthisAgreement;provided further,iftheDisputeisnotresolvedpursuanttoSection16.2,thePartiesagreethatsuch Dispute shall be resolved pursuant to Section 16.3.

 

|   | 6.10 | OptionProducts. |
|--------|------|-----------------|

 

(a)At any time during the Collaboration Term after the completion ofresearch activities under a Validation Research Plan, either Ultragenyx or Takeda may, through theJRC, nominateaCandidateProductforselectionasanOptionProduct,andtheJRCwillpromptly considersuchrequest.InorderforaCandidateProducttobecomeanOptionProduct,theJRC mustagree(bymutualagreementoftheParties’representativesontheJRC)to(i)theselection of the Candidate Product as an Option Product, (ii) a research plan, and budget that identifiesthe researchanddevelopmentactivitieswhichshallbeperformedandpaidforentirelyby Ultragenyx (each, an “Option Product Research Plan”), and (iii) key terms, includingthe territory,fieldofuse,developmentandcommercialresponsibilitiesandfinancialterms(the “OptionProductKeyTerms”)toserveasthebasisforanOptionProductLicenseAgreement. For clarity, the Option Product Research Plan for [***] Products is the [***] ResearchPlan.

 

(b)The [***] Products are designated as Option Products as of the Effective Date.The Option Product Key Terms for [***] Products are attached hereto as Exhibit6.10(b).

 

6.11TheUltragenyxOption.TakedaherebygrantstoUltragenyx,duringtheapplicable Collaboration Term, the exclusive option to obtain, on a product-by-product basis, an exclusive license,withtherighttograntsublicensesthroughmultipletiers,undertheOptionProduct Technology and Joint Intellectual Property to Exploit (a) the [***] Products and (b) up to five(5) otherOptionProductsintheLicensedFieldintheTerritory(the“UltragenyxOption”),subject to the terms and conditions set forth in this Agreement including ARTICLE8.

 

|   | 6.12 | Exercising theOption. |
|--------|------|-----------------------|

 

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(a)At any time during the Collaboration Term, Ultragenyx may exercisethe UltragenyxOptionregardinganOptionProductbynotifyingTakedainwritingofitsintentto exercise the Option with respect to a specific Option Product and negotiate the terms of alicense agreement(the“OptionNotice”).Duringtheperiodoftimebeginningontheeffectivedateof eachsuchOptionNoticeandending[***] thereafter,whichperiodmaybeextended bymutualagreement(the“OptionNegotiationPeriod”),thePartieswillconductgoodfaith negotiations with the intent to agree upon license terms and conclude a definitivelicense agreement (the “Option Product License Agreement”) in accordance with the applicableOption Product Key Terms and other terms that reflect the expected commercial opportunityand developmentstageoftheOptionProduct.AnysuchOptionProductLicenseAgreementwill include provisions to address approvals of any Governmental Authority which  arerequired before effectiveness of such Option Product LicenseAgreement.

 

(b)IfthePartiescannotconcludeanOptionProductLicenseAgreementduringthe Option Negotiation Period, Takeda and Ultragenyx shall each have the right to submit theOption Product Key Terms and other terms for a final decision regarding the terms  of  theOption Product License Agreement pursuant to binding arbitration under Section 16.3. All rights toany Option Product for which the Parties do not enter into an Option Product LicenseAgreement shall revert to Takeda and such Option Product shall be deemed a Terminated Product subjectto Section15.7(c).

 

ARTICLE 7  – TAKEDA RESEARCHSUPPORT

 

7.1Research Support. During the Collaboration Term and upon mutual agreement ofthe Parties, Takeda may provide research support as set forth in this Section 7.1(“ResearchSupport”) to Ultragenyx, at Ultragenyx’s sole cost. Such Research Support shall be related tothe developmentofUltragenyxPipelineProducts(ineachcase,otherthanExercisedProducts)or Licensed Option Products (in each case, in connection with an Option Product License Agreement), and shall include medicinal chemistry, testing of compounds in diseaseanimal models, drug formulation and clinical development support. If Ultragenyx and Takeda agreethat Takeda should provide such Research Support, the confidentiality obligations, access  to premises,andotherdetailsrelatedtoTakedapersonnelprovidingsuchResearchSupportto Ultragenyx shall be addressed in a separate agreement between the Parties and suchpersonnel.

 

7.2Expenses and Invoices. Ultragenyx shall reimburse Takeda for Takeda’s FTE Costs and out-of-pocket Third Party expenses, in each case, incurred by Takeda for the provision ofthe Research Support and in accordance with the applicable budget, subject to amaximum reimbursementobligationof [***]ofsuchbudgetorsuchgreater amount as Ultragenyx may approve in advance. Within forty-five (45) days after the end ofeach Calendar Quarter, Takeda will provide a written report and invoice to Ultragenyx setting forthin reasonabledetailitsFTEsanditsThirdPartyexpensesrecordedfortheResearchSupport. Withinsixty(60)daysafterthereceiptofsuchinvoice,Ultragenyxshallpaytheundisputed portion of any such invoice. For clarity, making such a payment does not preemptUltragenyx’s auditrightsunderSection11.12,whichremaininfullforceandeffect.IfUltragenyxingood faith identifies items in an invoice which are disputed, Ultragenyx will notify Takeda inwriting,

 

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notingitsobjectiontothedisputeditem(s)withspecificity,withinten(10)businessdaysof receiptoftheinvoice.Takedawillrespondtosuchwrittennotificationwithinten(10)daysof receipt of the disputed notification. Thereafter, the Parties shall negotiate in good faith toresolve thedisputewitheitherTakedasupplyingUltragenyxdocumentationjustifyingthechargeor reducing or deleting the disputed amount. Any dispute over invoiced amounts due that cannotbe resolved by direct good faith negotiation between the Parties shall be resolved in accordance withARTICLE16(DisputeResolution)ofthisAgreement;providedfurther,iftheDisputeis notresolvedpursuanttoSection16.2,thePartiesagreethatsuchdisputeshallberesolved pursuant to Section16.3.

 

7.3Patent Ownership. If Research Support is provided pursuant to Section 7.1 related toan Ultragenyx Pipeline Product (other than an Exercised Product), then, notwithstandingSection

12.1oranyotherseparatewrittenagreementbetweenthePartieswithrespecttosuchResearch Support,asbetweenthePartiesandregardlessofinventorship,Ultragenyxshallownallright, title and interest in and to any Patents related to such Ultragenyx Pipeline Product (other thanan Exercised Product in the Exercised Countries) that arise out of such Research Support.For purposes of clarity, following the execution of an Option Product License Agreementor Exercised Product License Agreement, the terms of such license agreement shall governthe handlingofactivitiesofthetypecoveredbythedefinitionofResearchSupportrelatedtothe Product(s) that are the subject of the applicable licenseagreement.

 

ARTICLE 8  – TAKEDA’S LICENSEOPTION

 

8.1The License Option. In partial consideration for the premium paid by Takedato Ultragenyx under the Common Stock Purchase Agreement, Ultragenyx hereby grants toTakeda during the applicable Takeda Option Term, the exclusive option to obtain (the “TakedaOption”), on a product-by-product and country-by-country basis, an exclusive license (even asto Ultragenyx and its Affiliates) to (a) any or all of the Licensed Products in the UltragenyxField,

(b)anyorallLicensedOptionProductsintheLicensedField,and(c)one(1)Ultragenyx PipelineProductintheLicensedField,ineachcaseinanyorallofthecountriesintheTakeda Territory.Forclarity,ifTakedaelectsnottoexercisetheTakedaOptionwithrespectto(i)any Licensed [***] Product, Licensed Analog Product, Licensed Option Product, orUltragenyx Pipeline Product, or (ii) any country in the Takeda Territory, as the case may be, prior tothe expirationoftheTakedaOptionTermwithrespecttosuchProductand/orsuchcountry,as applicable, then Takeda shall no longer have any rights under the Takeda Option with respectto such Product and/or such country, asapplicable.

 

|   | 8.2 | Exercising the LicenseOption. |
|--------|-----|-------------------------------|

 

(a)Preparation and Delivery of the Data Packages. Ultragenyx shall prepareand delivertoTakedaassoonasreasonablypracticableaftercompletionoftheapplicableClinical Trials (a) the Final Phase II Data Package for each Licensed [***] Product, LicensedAnalog Product, Licensed Option Product and Ultragenyx Pipeline Product (other than [***]) and(b) the Final Phase III Data Package for[***].

 

 

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(b)Takeda Review of Research Data Package. Following Takeda’s receipt ofthe applicableDataPackagepursuanttoSection8.2(a)andduringtheapplicableTakedaOption Term,TakedamayreviewandassesstheDataPackagetodeterminewhetheritwillsubmitthe Takeda Option Notice. During this review period, upon Takeda’s  reasonable request, Ultragenyx shall promptly make available to Takeda: (i) its employees, consultantsand independent contractors (subject to the availability of any independent contractors)who performed the activities on behalf of Ultragenyx, including the preparation of the DataPackage; and (ii) any additional Information under Ultragenyx’s possession and Control related tothe applicable products that is reasonably useful in evaluating the DataPackage.

 

(c)Takeda Option Exercise Mechanics. Takeda may exercise the TakedaOption for one or more Licensed [***] Products, one or more Licensed Analog Products, one ormore Licensed Option Products, and one Ultragenyx Pipeline Product on a country-by-country basisin the Takeda Territory at any time during the applicable Takeda Option Term by providingwritten notice to Ultragenyx (the “Takeda Option Notice”) identifying the applicableProducts (“ExercisedProducts”)andcountries(“ExercisedCountries”);provided,however,thatTakeda mayexercisetheTakedaOptionwithrespecttoeachLicensedProductonlyonce(i.e.,ifthe TakedaOptionisexercisedwithrespecttoaparticularLicensedProductforfewerthanall applicablecountries,thenadditionalcountriesmaynotbeaddedbyadditionalexercisesofthe Takeda Option with respect to that particular LicensedProduct).

 

(d)DuringtheperiodoftimebeginningontheeffectivedateoftheTakedaOption Notice and ending [***], which period may be extended bymutual agreement (the “Takeda Option Negotiation Period”), the Parties will conduct goodfaith negotiations to conclude a definitive license agreement (the “Exercised ProductLicenseAgreement”). Such Exercised Product License Agreement shall include thefollowing:

 

(i)thefollowinglicensegrantwithrespecttotheExercisedProductsinthe ExercisedCountries,which,totheextentofanyconflict,shallsupersedetheUltragenyx[***] License and Takeda [***] License and the terms of any Option Product LicenseAgreement: Ultragenyx hereby grants to Takeda an exclusive license (even as to Ultragenyx andits Affiliates), with the right to grant sublicenses through multiple tiers, under theUltragenyx IntellectualPropertyandJointIntellectualProperty,toExploittheExercisedProductsinthe UltragenyxField(wheresuchExercisedProductisaLicensedProduct)ortheLicensedField (where such Exercised Product is a Licensed Option Product or Ultragenyx Pipeline Product)in the ExercisedCountries;

 

(ii)financial terms in ARTICLE 11 (and related definitions) applicableto Exercised Products (and no other consideration payable byTakeda);

 

(iii)provisions to address approvals of any Governmental Authority whichare required before effectiveness of the Exercised Product LicenseAgreement;

 

(iv)provisions to address the prosecution, enforcement and defense ofPatents that cover Exercised Products similar to those contained in ARTICLE12;

 

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(v)the right for Takeda to terminate for convenience upon [***] written notice;

 

(vi)therightforTakedato,inlieuofterminationforUltragenyx’smaterial breach or insolvency, receive rights on the basis set forth in Section15.7(a)(ii)(B);

 

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(vii)provisionsthatupontheexpirationoftheTakedaRoyaltyTermforeach ExercisedProductineachExercisedCountry,Takedashallhaveanon-exclusive,fully-paidup and irrevocable license under the Ultragenyx Intellectual Property with respect to suchExercised ProductinsuchExercisedCountryintheUltragenyxField(forExercisedProductsthatare Licensed Products) and in the Licensed Field (for Exercised Products that are Option Productsor Ultragenyx Products);andARTICLE18.

(viii)to the extent applicable, Miscellaneous provisions as contained in

(e)IfthePartiescannotconcludetheExercisedProductLicenseAgreementduring theTakedaOptionNegotiationPeriod,TakedaandUltragenyxshalleachhavetherightto submitthetermsforafinaldecisionregardingtheterms(otherthanthosespecifiedinSection 8.2(d)) of the Exercised Product License Agreement pursuant to binding arbitration under Section16.3.Forclarity,thetermssetforthinSection8.2(d)mustbeincludedwithinthe Exercised Product License Agreement and are not subject to arbitration and Ultragenyx shallbe requiredtoenterintoanExercisedProductLicenseAgreementincludingthosetermsifthe Takeda Option is exercised pursuant to Section8.2(c).

 

8.3Takeda Right of First Negotiation on Ultragenyx Pipeline Products. Asadditional consideration for the premium being paid by Takeda to Ultragenyx under the CommonStock Purchase Agreement, and notwithstanding anything to the contrary contained in thisAgreement, if,during the[***] periodfollowingexpirationoftheapplicableTakedaOption Term,Ultragenyxintendstolicense(allorasubsetofallrights)orotherwisetransferany UltragenyxPipelineProducttoaThirdPartyintheTakedaROFNTerritory,Ultragenyxwill provideTakedawithpriorwrittennoticeofsuchintentand,foraperiodof[***] after receipt of such notice, Takeda will have a right of first negotiation to enter intoa definitiveagreementwithUltragenyxforsuchlicense(ofallorasubsetofallrights)orother transfer in the Takeda ROFN Territory. If the Parties fail to enter into a  definitiveagreement prior to the expiration of the [***] period, Ultragenyx will have theright toenterintoadefinitiveagreementwithaThirdPartyforthelicense(ofallorasubsetofall rights) or other transfer of such Ultragenyx Pipeline Product in the Takeda ROFNTerritory.

 

8.4Transition of Responsibilities After Exercise of the Takeda Option. Ultragenyxshall, inaccordancewithatransitionplansetforthintheExercisedProductLicenseAgreement, transfer to Takeda all activities and responsibilities related to the Exercised Products inthe Exercised Countries. The Parties shall exercise Commercially Reasonable Efforts to complete thetransferinaccordancewithsuchtransitionplan.AnydisputebetweenthePartiesregarding the transition shall be resolved as set forth in the Exercised Product LicenseAgreement.

 

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8.5Development and Commercialization After Exercise of the Takeda Option.After exercise of the Takeda Option, Takeda will use Commercially Reasonable Efforts to Exploitthe ExercisedProductsintheTakedaOptionFieldintheExercisedCountriesatitssolecostand expense; provided, however, notwithstanding the above, Takeda’s financial commitmenttoward globalDevelopmentcostsforLicensedOptionProductsandanUltragenyxPipelineProducts will be in accordance with the terms set forth in Section8.6.

 

8.6Cost Sharing for Development Activities in Takeda Territory. After exercise ofthe Takeda Option with respect to a Licensed Option Product and/or an Ultragenyx PipelineProduct:

 

(a)thePartieswillsharethecostsoffutureglobalDevelopmentactivitiesforsuch Licensed Option Product or Ultragenyx Pipeline Product, as applicable, including costsfor Clinical Trials and clinical drug supply and chemistry, manufacturing andcontrols-related activities in accordance with mutually agreed upon Development plans, budgets and costsharing structures; provided that Takeda shall only be required to share global Development costswhere the Development activities are necessary or reasonably useful to support theDevelopment, RegulatoryApprovalandCommercializationofsuchproductintheTakedaTerritory,inwhich caseTakedawillcontribute[***].Forclarity,Takedawillnotberequiredto shareinthecostsoffutureglobalDevelopmentactivitieswheretheDevelopmentactivities, including Clinical Trials, are not necessary and are not used to support theDevelopment,

Regulatory Approval and Commercialization of such product in the Takeda Territory;and

 

(b)Notwithstanding the foregoing, Takeda shall be solely responsible forall DevelopmentcostswheretheDevelopmentactivitiesarerequiredspecificallyandsolelyfor Regulatory Approval of a Licensed Option Product or Ultragenyx Pipeline Product,as applicable, in the Takeda Territory. If such Development activities are also necessaryor reasonablyusefulforRegulatoryApprovalofaLicensedProduct,LicensedOptionProductor Ultragenyx Pipeline Product, as applicable, outside the Takeda Territory, the Partieswill negotiate in good faith to agree upon an equitable sharing of costs for suchDevelopment activities.

 

ARTICLE 9  –REGULATORY

 

9.1Lead Regulatory Party.  Primary regulatory responsibility under this Agreementshall beassignedtooneoftheParties(suchParty,the“LeadRegulatoryParty”)assetforthinthis Section 9.1.

 

(a)Ultragenyx shall be the Lead Regulatory Party for all Licensed Productsuntil expirationofthe[***]OptionTerm.Followingexpirationofthe[***]OptionTerm,whetheror notUltragenyxhasexercisedthe[***]Option(i)TakedashallbetheLeadRegulatoryPartyfor Licensed [***] Products in the Takeda Field unless otherwise agreed by the Parties, and(ii) Ultragenyx shall be the Lead Regulatory Party for Licensed [***] Products in the UltragenyxField and shall be the Lead Regulatory Party for Licensed Analog Products in the UltragenyxField.

 

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(b)Ultragenyx shall be the Lead Regulatory Party for all UltragenyxPipeline Products in the Territory until expiration of the Takeda Option Term. Following the expiration oftheTakedaOptionTerm,UltragenyxshallbetheLeadRegulatoryPartyintheTerritoryfor all Ultragenyx Pipeline Products for which the Parties have not entered into an ExercisedProduct License Agreement. For clarity, at all times Ultragenyx shall be the Lead Regulatory Party for all Ultragenyx Pipeline Products outside of the Takeda Territory. If Takeda exercises theTakeda Option with respect to an Exercised Product, the Exercised Product License Agreementshall provide that Takeda shall be the Lead Regulatory Party for such Exercised Product inthe Licensed Field in the TakedaTerritory.

 

(c)The Parties will agree as to which Party shall be the Lead Regulatory Party forthe [***]ProductsandeachCandidateProductpriortotheexpirationoftheCollaborationTerm; provided, however, that Takeda shall be the Lead Regulatory Party (i) if the Parties are unableto agree,(ii)atanytimeafterUltragenyxprovidesTakedawrittennoticethatitwillnotexercise theUltragenyxOptionwithrespecttothe[***]Productsand(iii)fortheplannedScientific Advice with the Dutch Medicines Evaluation Board and US Orphan Drug Designationfollow-up (as needed) for [***]. Ultragenyx shall be the Lead RegulatoryParty foreachOptionProductforwhichthePartieshaveenteredintoanOptionProductLicense Agreement and Takeda shall be the Lead Regulatory Party for each Option Product for whichthe Parties have not entered into an Option Product LicenseAgreement.

 

(d)Inaccordancewiththeforegoing,uponenteringintoanOptionProductLicense Agreement or Exercised Product License Agreement, it is understood that the terms ofsuch OptionProductLicenseAgreementorExercisedProductLicenseAgreementwillgovernwith respect to such Option Product covered by such Option Product License Agreement orExercised Product covered by such Exercised Product License Agreement, asapplicable.

 

9.2Initial Transfer of Data and RegulatoryMaterials.

 

|   | (a) | Transfer toUltragenyx |   |
|--------|-----|-----------------------|--------|

 

(i)AssoonaspracticableaftertheEffectiveDate,butinanyeventnolater than sixty (60) days after the Effective Date, Takeda shall timely transfer to Ultragenyx copiesof

(A) all Regulatory Materials (in electronic or other format) in its possession related to the useof theLicensed[***]ProductsintheUltragenyxField(and,solelyforpurposesofUltragenyx’s performance of its obligations under Section 4.3(a)(ii), in the Takeda Field) and (B) the briefing book, FDA meeting minutes, Takeda meeting minutes, and FDA correspondence associated with  [***], the US Orphan Drug Designation Request and subsequent regulatory correspondence, and the briefing book and correspondence for Scientific Advice with the Dutch Medicines Evaluation Board,  in each case for the [***] Products inthe LicensedFieldandexistingasofsuchdateoftransfer.Followingeachsuchtransferandata time to be mutually agreed by the Parties, the Parties shall take all steps necessary (a)for Ultragenyx to own or have the right of reference to the INDs and RegulatoryApprovals necessary to conduct Development of the Licensed [***] Product in the Ultragenyx Field and(b) for Takeda to own or have the right of reference to the INDs and RegulatoryApprovals necessary to conduct Development of the Licensed [***] Product in the TakedaField.

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(ii)Within sixty (60) days after the Effective Date, Takeda shallmake availabletoUltragenyxseparatecopies(inelectronicorotherformat)ofthestudyreports from all non-clinical trials and Clinical Trials in the Territory, in each case, whether completed as of the Effective Date or then in-progress, that are Controlled by Takeda (to the extent not previouslyprovidedtoUltragenyx),assuchreportsbecomeavailabletoTakeda,andtothe extent that they relate to the use of the Licensed [***] Products for theTerritory.

 

|   | (b) | Transfer toTakeda |   |
|--------|-----|-------------------|--------|

 

(i)As soon as practicable after the effective date of an ExercisedProduct License Agreement for a given Exercised Product, but in any event no later than sixty (60)days after such date, Ultragenyx shall timely transfer to Takeda copies of all Regulatory Materials(in electronic or other format) in its possession related to the use of the Exercised Product inthe Exercised Countries and which support the Product INDs, the Product Regulatory Approvalsand associatedcorrespondence,existingasofsuchdateoftransfer.Promptlyaftersuchtransfer, Ultragenyx shall take all steps necessary to transfer ownership of all such Product INDsand Product Regulatory Approvals in the Takeda Territory to Takeda, including, ifapplicable,submitting to the PMDA a letter or other necessary documentation (with a copy to Takeda) notifyingthePMDAofthetransferofsuchownership.FromtimetotimeaftertheINDDate, andsolelytotheextentnotpreviouslydisclosed,Ultragenyxshall,andshallcauseitsAffiliates to,withoutadditionalcompensation,discloseandmakeavailabletoTakeda,inwhateverform Takedamayreasonablyrequest,allRegulatoryMaterialsControlledbyUltragenyxandrelated to the use of an Exercised Product in the ExercisedCountries.

 

(ii)Within sixty (60) days after the Parties enter into an ExercisedProduct LicenseAgreementforagivenExercisedProduct,UltragenyxshallmakeavailabletoTakeda separate copies (in electronic or other format) of the study reports from all non-clinical trialsand Clinical Trials in the Territory, in each case, whether completed as of the Effective Date, thatare ControlledbyUltragenyx(totheextentnotpreviouslyprovidedtoTakeda),assuchreports become available to Ultragenyx, and to the extent that they relate to the use of theExercised Products in the ExercisedCountries.

 

|   | 9.3 | Preparation of RegulatoryMaterials. |   |
|--------|-----|-------------------------------------|--------|

 

(a)AftertheEffectiveDate(or,asapplicable,theINDDate),theLeadRegulatory Partyshallhavethesolerightandresponsibility,andshallexerciseCommerciallyReasonable Efforts,toprepare,obtain,andmaintain,asapplicable,theRegulatoryMaterials,includingthe Product INDs, the Product Regulatory Approvals, and other submissions, and toconduct communications with the FDA, for the relevant Products in the applicable indication inthe Territoryorapplicableportionthereof,exceptinthecaseofLicensed[***]Productsfromthe Effective Date until expiration of the [***] Option Term, during which time Takeda shall holdthe INDandUltragenyx(i.e.,theLeadRegulatoryParty)shallreceivearightofreferencefrom Takeda. Except with respect to Licensed [***] Products from the Effective Date until expirationof the[***]OptionTerm,allProductINDsandProductRegulatoryApprovalsgeneratedafterthe EffectiveDate,includinganysupplementsoramendmentstothoseProductINDsandProduct Regulatory Approvals in existence as of the Effective Date, with respect to such Products inthe

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applicable indication in the Territory or applicable portion thereof under this Agreement shallbe ownedby,andshallbethesolepropertyandheldinthenameof,LeadRegulatoryPartyorits designee.

 

(b)Otherthanthe Scientific Advice Briefing Book for the [***] Products which has been prepared as of the Execution Date but not yet been submitted, the Lead Regulatory Party shall provide the other Party with an opportunity to review and comment on all material Regulatory Materials submitted by the Lead Regulatory Party to a Regulatory Authority after the Effective Date, in each case reasonably in advance of when the Lead Regulatory Party intendsto submit such Regulatory Materials to the applicable Regulatory Authority. The other Partyshall provideitscommentswithin[***],orsuchotherperiodoftimemutually agreed to by the Parties. The Lead Regulatory Party shall consider in good faith anysuch commentsoftheotherParty.TheLeadRegulatoryPartyshallprovidetheotherPartywitha copy in electronic form of all material Regulatory Materials filed with the RegulatoryAuthority related to the use of the relevantProducts.

 

(c)TheLeadRegulatoryPartyshallnotifytheotherPartywithinnolessthan [***]ofanyrequestforameetingorsubstantivetelephoneconferencecallwitha Regulatory Authority with respect to any Product IND or Product Regulatory Approval.Upon the other Party’s request, the Lead Regulatory Party shall request that the FDA orother RegulatoryAuthoritypermitatleast [***]oftheotherParty’semployeestoattendanysuch meetingorconferencecall.TotheextentpermittedbytheFDAorotherRegulatoryAuthority, the other Party shall have the right to participate in any such meeting or conference call.The foregoingrightsandobligationsapplywithrespecttomeetingsorconferencesinitiatedbythe Lead Regulatory Party or by a Regulatory Authority. The Lead Regulatory Party shallpromptly furnish the other Party with copies of all substantive correspondence related to therelevant ProducttheLeadRegulatoryPartyhashadwiththeRegulatoryAuthority,andcontactreports concerning substantive conversations or minutes from any substantive meetings witha Regulatory Authority related to suchProduct.

 

(d)Notwithstanding the foregoing, Takeda, in consultation with Ultragenyx, shallbe responsible for the preparation of any components of Regulatory Materials to be filedby Ultragenyx that relate to the Manufacture of a Licensed Product or Option Product. Takedashall use Commercially Reasonable Efforts to prepare such components in a timely mannerand provide such components to Ultragenyx with sufficient time for Ultragenyx to reviewand comment on such components; provided, however, that Takeda may use analternative arrangement(suchasadrugmasterfile)topreservetheconfidentialityofsuchcomponentsto the extent required by any Third Party agreements or, in Takeda’s reasonable discretion,if otherwise necessary to protect Takeda confidential information and such alternativearrangement ispermissibleunderApplicableLaws;provided,further,thatifUltragenyxreasonablyrequests additionalinformationwithrespecttotheDevelopmentorCommercializationofaLicensed ProductorOptionProductotherwisetreatedasconfidentialinsuchalternativearrangement (suchasadrugmasterfile),Takedashallreasonablyconsidersuchrequest.Intheeventthat Ultragenyx elects to Manufacture a Licensed Product or Option Product, Ultragenyx shallnotify Takeda of such election and, to the extent covered by the license rights granted in Sections3.1(a)

 

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and 3.1(c) (for Licensed Products) or Section 6.5(a) (for Option Products), Takeda shall promptlytransfertoUltragenyxoritsThirdPartydesigneeallRegulatoryMaterials,processes andtechnicalinformationControlledbyTakedaoritsAffiliatesthatarereasonablynecessary andusefulfortheManufactureofsuchLicensedProductorOptionProduct,andthereafter UltragenyxshallberesponsibleforthepreparationofanycomponentsofRegulatoryMaterials to be filed related to the Manufacture by Ultragenyx or its Third Party designee of suchLicensed Product or OptionProduct.

 

|   | 9.4 | Cooperation, Consultation and Review. |
|--------|-----|---------------------------------------|

 

(a)ThePartiesshallcooperatewitheachothertoachievetheregulatoryobjectives contemplated herein in a timely, accurate and responsive manner and shall assist the otherParty as reasonably requested in connection with the preparation and filing of Regulatory Materialsin theLicensedField,whetherinoroutsideoftheTerritory.ThePartiesshallestablishajoint regulatoryworkinggrouptomanageLicensedProductregulatoryactivitiesandissues.Itisthe intentionofthePartiesthatthejointregulatoryworkinggroupshallmeet(inpersonorvia teleconference) on an as-needed basis after the Effective Date and throughout the Term, but ata minimum on a quarterly basis. The Parties agree and acknowledge that the activitiesof Ultragenyxwithrespectto(i)Licensed[***]ProductsintheUltragenyxFieldand(ii)Licensed Analog Products in the Licensed Field and the activities of Takeda with respect to (A)Licensed [***] Products in the Takeda Field and (B) Licensed Products outside of the Licensed Field,shall be coordinated such that they are consistent with the overall objective of facilitatingRegulatory Approvals.

 

(b)The other Party shall assist the Lead Regulatory Party, as is reasonablynecessary, in order for the Lead Regulatory Party to obtain and maintain the Product INDs and theProduct Regulatory Approvals, including in connection with the preparation and filing ofRegulatory Materials necessary to maintain such Product INDs and Product RegulatoryApprovals.

 

9.5Regulatory Costs and Expenses. Each Party shall bear its own costs andexpenses incurred related to the preparation, maintenance, formatting and filing of theRegulatory Materials.

 

9.6Rights of Reference to Regulatory Materials. Each Party hereby grants to theother PartyarightofreferencetoallRegulatoryMaterials,includinganydatareliedoninsupportof such Regulatory Materials, solely for the purpose of seeking, obtaining andmaintaining RegulatoryApprovalsfortheProducts,consistentwiththerolesofthePartiessetforthinthis Agreement.

 

9.7Labeling Information Exchange/Labeling Agreement. The Parties shall cooperateto develop methods and/or procedures for sharing information related to Labeling. Specificdetails regarding the management of Labeling information, including CCDS will be delineated ina separate Labeling agreement that shall be agreed upon by theParties.

 

|   | 9.8 | Adverse Event Reporting and Safety DataExchange. |
|--------|-----|--------------------------------------------------|

 

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(a)Safety Information Exchange; PharmacovigilanceAgreement.

 

(i)The Parties shall cooperate to develop methods and/or proceduresfor sharing information relating to the clinical experiences in accordance with safetyreporting requirementsoftherespectiveRegulatoryAuthoritiesandasnecessaryforaPartytocomply with Applicable Laws. Specific details regarding the management of safety information includingadverseeventsreportsrelatedtotheDevelopmentandtheCommercializationofthe Products will be delineated in a separate global pharmacovigilance agreement (the “PVA”)that shall be agreed to by the Parties as soon as reasonably practicable, but in any event not later than [***] of the Effective Date. The Lead Regulatory Party shallbe responsible for the compliance and filing of all required safety reports to theRegulatory Authorities in the Territory, including annual safety reports, throughout theTerm.

 

|   | (ii) | The PVA shall provide asfollows: |   |
|--------|------|----------------------------------|--------|

 

(A)Unless otherwise agreed by the Parties, the LeadRegulatory PartyshallmaintaintheglobalsafetydatabasefortheProducts,andmirrordatabaseswillbe maintained by the other Party; provided, however, that Takeda shall maintain the globalsafety databaseregardingLicensed[***]Products,andUltragenyxshallmaintaintheglobalsafety database regarding Licensed Analog Products. For clarity, to the extent a Party is nolonger actively Developing or Commercializing a Licensed [***] Product, then the globalsafety database shall be transferred to the Party that continues to actively Develop orCommercialize such Licensed [***]Product.

 

(B)Each Party shall timely report to the other Party allclinical experiences, safety monitoring, and pharmacovigilance surveillance observed in theTerritory, which in all cases shall be (i) for clinical studies: as soon as practicable, [***]and(ii)forcommercial Products: [***]; exchange of information shallbe onaCouncilforInternationalOrganizationsofMedicalSciencesSuspectAdverseReaction Report Form (“CIOMSForm”).

 

(C)The other Party shall prepare and provide to theLead RegulatoryPartyonatimelybasissafetyupdatesinorderfortheLeadRegulatoryPartyto meetthesafetyreportsubmissionrequirementsnecessarytomaintaintheProductINDsand the Product RegulatoryApprovals.

 

(b)Regulatory Reporting of Safety Information.  The Parties shall work together to achieve consensus with respect to safety issues related to the Products, including urgentsafety information, and to report said opinion to safety boards, investigators, and toapplicable RegulatoryAuthorities.Intheeventthat,afterreasonablemedicalandscientificconsultation, the Parties cannot achieve consensus with respect to safety issues to be reported to any applicableRegulatoryAuthority,theLeadRegulatoryPartyshallhavefinaldecisionmaking

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authority with respect to the Products in the Licensed Field in the Territory.Notwithstanding anything to the contrary in this Agreement, either Party may report safety matters to aRegulatory Authoritythatitreasonablydeterminesarenecessarytoreportpriortotheconclusionofthe dispute resolutionprocedure.

 

9.9Regulatory Authority Communications Received by a Party. Each Party shallinform the other Party in a timely manner, not to exceed [***], of the notification ofany action by, or notification or other information which it receives (directly or indirectly) fromany Regulatory Authority which: (i) raises any material concerns regarding the safety or efficacy ofa Product; (ii) indicates or suggests a potential material liability of either Party to Third Partiesin connection with a Product; (iii) is reasonably likely to lead to a recall or market withdrawal ofa Product;or(iv)relatestoexpeditedreportsofadverseeventswithrespecttoaProduct,or Product Complaints, and which may have a material impact on obtaining ormaintaining Regulatory Approval or the continued Commercialization of a Product, as then conducted.The other Party will fully cooperate with and assist such Party in complying withregulatory obligations and communications, including by providing to such Party, in a timely manner aftera request, such information and documentation in the other Party’s possession as may benecessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority.Each Party will provide the other Party in a timely manner with a copy of all correspondencereceived from a Regulatory Authority specifically regarding the matters referred toabove.

 

9.10Audit.IfaRegulatoryAuthoritydesirestoconductaninspectionorauditofaParty’s facility or a facility under contract with such Party with regard to a Product in the Territory,then the audited Party shall notify the other Party as soon as practicably possible after receipt ofsuch notification of such audit or inspection and provide copies of any materials provided to it bythe applicable Regulatory Authority; provided, that the audited Party shall not be required tonotify the other Party of audits or inspections that are of a routine nature or that do not relate toa Product, except where such audits result in communications or actions of suchRegulatory AuthoritywhichhaveadirectimpactuponaProduct.Inaddition,ifaRegulatoryAuthority conducts an unannounced inspection or audit of a Party’s facility or a facility under contractwith such Party with regard to a Product in the Territory, then the audited Party shall notify theother Party within [***] of commencement of such audit or inspection. Theaudited Party shall cooperate, and shall use reasonable efforts to cause the contract facility tocooperate, with such Regulatory Authority and the other Party during such inspection or audit.Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of whichthe audited Party will immediately provide to the other Party), the audited Party will also providethe otherPartywithcopiesofanywrittencommunicationsreceivedfromRegulatoryAuthorities with respect to such facilities in a timely manner after receipt, to the extent suchwritten communicationsrelatedirectlytoaProductortheManufacturethereof,andwillpreparethe response to any such observations. The audited Party will provide the other Party with a copyof any proposed response to such communications and will consider in good faith  suchother Party’s reasonable comments with respect to such proposed response. The audited Party agrees to conform its activities under this Agreement to any commitments made in such aresponse.

 

 

 

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9.11Recalls and Voluntary Withdrawals. Each Party shall notify the other Partypromptly butinnoeventlaterthan[***]followingitsdeterminationthatanyevent, incident, or circumstance has occurred that may result in the need for a recall, marketsuspension, or market withdrawal of a Product under any MAA or Regulatory Approval for the Productheld bysuchPartyandfiledwithRegulatoryAuthoritiesintheTerritory,andshallincludeinsuch notice the reasoning behind such determination, and any supporting facts. Such Party shallhave the sole right to make the final determination whether to voluntarily implement any suchrecall, marketsuspension,ormarketwithdrawalintheTerritory;providedthatpriortoany implementationofsucharecall,marketsuspension,ormarketwithdrawal,thesuchPartyshall, to the extent practical, consult with the other Party and shall consider the other Party’scomments in good faith. For all recalls, market suspensions or market withdrawals undertaken pursuantto thisSection9.11,suchPartyshallbesolelyresponsiblefortheexecutionthereof,andtheother Partyshallreasonablycooperateinallsuchrecallefforts.SubjecttoARTICLE17,suchParty shallberesponsibleforallcostsofanysuchrecall,marketsuspension,ormarketwithdrawal; provided that, the other Party shall be responsible for the costs of any recall, marketsuspension, or market withdrawal with respect to a Product in the Territory to the extent such recall,market suspension, or market withdrawal is attributable to the other Party’s breach of itsobligations hereunder or its negligence, recklessness or willfulmisconduct.

 

ARTICLE 10  – MANUFACTURING AND SUPPLY

 

10.1 Supply Agreement. The Parties shall enter into mutually agreeable supply agreementsas soon as appropriate after the Effective Date covering the manufacture and research supply(other than as provided in Section 6.6), clinical supply or Commercial supply of Compoundsor Products needed for Development orCommercialization.

 

ARTICLE 11  – PAYMENT

 

11.1Licensed Product Development Milestones Payable toTakeda.

 

(a)UltragenyxshallpaytoTakedaamilestonepaymentwithinforty-five(45)days after the first achievement of each of the following milestones for each LicensedProduct, calculated as follows:

 

(i)[***];

 

(ii)upon Regulatory Approval of [***];

 

(iii)upon both (A) Regulatory Approval of [***] and (B) Pricing Approval [***]

 

(iv)[***];

 

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(v)upon Regulatory Approval of [***];and

 

(vi)upon both (A) Regulatory Approval of [***] and (B) Pricing Approval [***]

 

(b)EachmilestonepaymentinthisSection11.1shallbepayableonlyuponthefirst achievementofsuchmilestoneforeachLicensedProductandnoamountsshallbeduefor subsequent or repeated achievements of such milestone for the same LicensedProduct.

 

|   | 11.2 | Licensed Product Sales Milestones Payable toTakeda. |
|--------|------|-----------------------------------------------------|

 

(a)UltragenyxshallpaytoTakedaamilestonepaymentwithin[***] afterthefirstachievementofeachofthefollowingmilestonesfortheaggregatedannualNet Sales of all Licensed Products, calculated asfollows:

 

(i)upon the Net Sales in the Territory of all Licensed Products madeby Ultragenyx, its Affiliates and Sublicensees in a given Calendar Year equaling or exceeding[***];

 

(ii)upon the Net Sales in the Territory of all Licensed Products madeby Ultragenyx, its Affiliates and Sublicensees in a given Calendar Year equaling or exceeding[***];and

 

(iii)upon the Net Sales in the Territory of all Licensed Products madeby Ultragenyx, its Affiliates and Sublicensees in a given Calendar Year equaling or exceeding[***].

 

(b)EachmilestonepaymentinthisSection11.2shallbepayableonlyuponthefirst achievementofsuchmilestoneforallLicensedProductsinaggregateandnoamountsshallbe due for subsequent or repeated achievements of such milestone. If two or more milestoneevents are achieved in the same Calendar Year, Ultragenyx shall pay to Takeda each milestonepayment corresponding to the respective milestoneevent.

 

11.3Licensed Product Royalties Payable to Takeda. Subject to Section 11.8 below,and duringtheapplicableLicensedProductRoyaltyTerm,UltragenyxshallpaytoTakeda,ona LicensedProduct-by-LicensedProductbasis,arunningroyaltyatthefollowingincremental royalty rates, on Net Sales of each Licensed Product in the Territory in a CalendarYear:

 

|                                                       |             |
|-------------------------------------------------------|-------------|
| Net Sales in theTerritory                             | RoyaltyRate |
| For that portion of annual Net Sales less than $[***] | [***]%      |
| For that portion of annual Net Sales greater thanor   | [***]%      |

 

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|                                                                                          |        |
|------------------------------------------------------------------------------------------|--------|
| equal to $[***] but less than $[***]                                                     |
| For that portion of annual Net Sales greater thanor equal to $[***] but less than $[***] | [***]% |
| For that portion of annual Net Sales greater thanor equal to $[***]                      | [***]% |

 

|   | 11.4 | Exercised Product Milestones and Fees Payable toUltragenyx. |
|--------|------|-------------------------------------------------------------|

 

(a)PursuanttotheapplicableExercisedProductLicenseAgreement,Takedashall paytoUltragenyxamilestonepaymentof[***]within[***]afterthefirstRegulatoryApprovalinthefirstindicationinJapanfor[***] if such product is an Exercised Product that hasnot been terminated at the time of such Regulatory Approval. The milestone payment in thisSection 11.4(a) shall be payable only upon the first achievement of such milestone for eachsuch Exercised Product and no amounts shall be due for subsequent or repeated achievements ofsuch milestone for such Exercised Product. For clarity, the maximum aggregate amount payable by TakedaforeachExercisedProductpursuanttothisSection11.4(a)is[***].

 

(b)For all Ultragenyx Pipeline Products other than [***], during the Takeda Option Negotiation Period for such Ultragenyx Pipeline Products, theParties will negotiate in good faith (for inclusion in the applicable Exercised ProductLicense Agreement) commercially reasonable financial terms in addition to the royalties contemplatedin Section 11.6 (such as one or more of the following: option exercise fees, sales anddevelopment milestones, reimbursement for historical research and development costs allocable to Japan,and milestones due to Third Party licensors) for such Ultragenyx Pipeline Products, takinginto considerationfactorssuchastheinvestmentinthecollaborationunderthisagreementalready made by Takeda, including the premium paid by Takeda to Ultragenyx under the CommonStock PurchaseAgreement.IfthePartiescannotreachagreementonsuchcommerciallyreasonable financial terms during the Takeda Option Negotiation Period, either Takeda or Ultragenyxmay seek a final decision regarding the commercially reasonable financial terms pursuant tobinding arbitration as set forth in Section 16.3.

 

11.5Licensed Product Royalties Payable to Ultragenyx for the ExercisedCountries. Subject to Section 11.8 below, and during the applicable Licensed Product Royalty Term, pursuanttotheapplicableExercisedProductLicenseAgreement,Takedashallpayto Ultragenyx, on a Licensed Product-by-Licensed Product basis, a running royalty at thefollowing incrementalroyaltyrates,onaggregate,NetSalesofeachExercisedProductthatisaLicensed Product in the Exercised Countries in a CalendarYear:

 

(a)IftheTakedaOptionforsuchLicensedProductisexercisedbyTakedapriorto Takeda’s receipt of the Final Phase II Data Package for such LicensedProduct:

 

 

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|                                                                                          |             |
|------------------------------------------------------------------------------------------|-------------|
| Net Sales in the ExercisedCountries                                                      | RoyaltyRate |
| For that portion of annual Net Sales less than$[***]                                     | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***] but less than $[***] | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***] but less than $[***] | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***]                      | [***]%      |

 

(b)If the Takeda Option for such Licensed Product is exercised by Takedaafter Takeda’s receipt of the Final Phase II Data Package for such LicensedProduct:

 

|                                                                                          |             |
|------------------------------------------------------------------------------------------|-------------|
| Net Sales in the ExercisedCountries                                                      | RoyaltyRate |
| For that portion of annual Net Sales less than$[***]                                     | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***] but less than $[***] | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***] but less than $[***] | [***]%      |
| For that portion of annual Net Sales greater thanor equal to $[***]                      | [***]%      |

 

11.6Licensed Option Product and Ultragenyx Pipeline Product Royalties Payableto Ultragenyx for the Exercised Countries. During the Takeda Option Negotiation Period fora Licensed Option Product or Ultragenyx Pipeline Product, the Parties will negotiate in goodfaith (forinclusionintheapplicableExercisedProductLicenseAgreement)tieredroyaltyrateson annual Net Sales of such Licensed Option Product or Ultragenyx Pipeline Product to be paidby Takeda to Ultragenyx during the Takeda Royalty Term. If the Parties cannot reach agreementon such tiered royalty rates during the Takeda Option Negotiation Period, either Takedaor Ultragenyxmayseekafinaldecisionregardingtheroyaltyratespursuanttobindingarbitration as set forth in Section16.3.

 

11.7Royalty Reduction for Generic Product Entry in a Country. On a LicensedProduct- by-Licensed Product basis, the royalty rates set forth in Sections 11.3 and 11.5 for Net Sales ofa Productinacountryshallbereducedby[***]ineachCalendarQuarterduring which the Generic Competition Percentage with respect to such Licensed Product in such country in such Calendar Quarter is greater than or equal to [***].

 

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|   | 11.8 | Payment for Third PartyLicenses. |
|--------|------|----------------------------------|

 

(a)EachPartywillberesponsibleforpayingallThirdPartylicensefees,royalties, and/or milestones, with respect to Third Party licenses entered into by such Party or itsAffiliates prior to or on the Effective Date or during the Term, for intellectual property that is necessaryor reasonably useful for the Exploitation of any Licensed Product. For such Third Party licensesto Preexisting Third Party IP, the paying Party will be entitled to deduct up to [***] of such amounts due to any such Third Party from royalties payable to the other Party hereunderon suchLicensedProduct.ForsuchThirdPartylicensesobtainedduringtheTerm,thepaying Party will be entitled to deduct [***] of such amounts due to any such ThirdParty from royalties payable to the other Party hereunder on such Licensed Product.Notwithstanding theforegoing,innoeventshallsuchroyaltypayabletoTakedainanyCalendarQuarterasa resultofthisreductionbelessthan[***] oftheamountthatwouldotherwisebe due.

 

(b)Ultragenyx shall be responsible for paying all Third Party license fees,royalties, and/or milestones, with respect to Third Party licenses for intellectual property that isnecessary or reasonably useful for the Exploitation of any Ultragenyx Pipeline Product, where such licensesareenteredinto(i)priortoorontheEffectiveDateor(ii)unlessanduntilsuch Ultragenyx Pipeline Product is an Exercised Product, during the Term. Each Party will be responsibleforpayingallThirdPartylicensefees,royalties,and/ormilestones,withrespectto Third Party licenses for intellectual property that is necessary or reasonably useful forthe Exploitation of any Ultragenyx Pipeline Product that is an Exercised Product entered into by such Party or its Affiliates on or after the date on which it becomes an Exercised Product.For suchThirdPartylicensesobtainedbyTakedaoritsAffiliates,Takedawillbeentitledtodeduct [***] ofsuchamountsduetoanysuchThirdPartyfromroyaltiespayableto Ultragenyx on such Exercised Product. Notwithstanding the foregoing, in no event shallthe royaltypayabletoUltragenyxinanyCalendarQuarteronsuchExercisedProductasaresultof this reduction be less than [***] of the amount that would otherwise bedue.

 

(c)Notwithstanding the foregoing, for intellectual property held by a Third Partythat is necessary or reasonably useful for the Exploitation of any Exercised Products in boththe ExercisedCountriesandothercountriesintheTerritory,thePartieswillcoordinatelicense negotiations with such Third Party for rights in both the Exercised Countries and othercountries in theTerritory.

 

11.9Manner of Royalty Payment. Each Party will  calculate and report royalty payments duebysuchPartytotheotherPartyunderSection11.3or11.5,asapplicable,eachCalendar Quarter. Each Party shall pay all royalty payments due under Section 11.3 or 11.5, asapplicable, within sixty (60) days after the end of each Calendar Quarter and shall include  witheach paymentareportcontainingthefollowinginformationfortheapplicableCalendarQuarter:(a) the amount of gross sales (in U.S. dollars) of the Products in the Territory; (b) anitemized calculationofNetSalesintheTerritoryshowingdeductions,totheextentapplicable,provided forinthedefinitionof“NetSales”;(c)acalculationoftheroyaltypaymentdueonsuchsales;

(d)anaccountingofthenumberofunitsandpricesfortheProductssold;and(e)applicationof

 

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thereductions,ifany,madeinaccordancewiththetermsofSection11.7and11.8.Within twenty(20)BusinessDaysaftertheendofeachCalendarQuarter,eachPartyshallprovidea preliminary report as described above for the most recent Calendar Quarter then ended.Each Partyshallreasonablycooperatetoreconcileanydeviationsandconfirmtheaccuracytothe extent necessary under Applicable Laws, GAAP orIFRS.

 

11.10ExchangeRate.Therateofexchangetobeusedincomputingtheamountofcurrency equivalentinU.S.DollarsowedtoaPartyunderthisAgreementshallbeequaltotheweighted averageexchangerate,overtheapplicableCalendarQuarter,betweeneachcurrencyoforigin and U.S. Dollars as reported by OANDA (www.oanda.com), or an equivalent resource asagreed bytheParties,onthelastBusinessDayoftheCalendarQuarterinwhichtheapplicableNet Sales weremade.

 

|   | 11.11 | Taxes |
|--------|-------|-------|

 

(a)Cooperation and Coordination. The Parties acknowledge and agree that itis their mutual objective and intent to appropriately calculate, to the extent feasible and legal,taxes payable with respect to their collaborative efforts under this Agreement and that they shall useall commerciallyreasonableeffortstocooperateandcoordinatewitheachothertoachievesuch objective. Ultragenyx shall cooperate with Takeda in seeking any tax exemption or creditsthat may be available to Takeda with respect to any research which Takeda or its affiliates performor fund under this Agreement, including any credits under section 45C of the U.S. InternalRevenue Code of 1986, asamended.

 

(b)PaymentofTax.APartyreceivingapaymentpursuanttothisARTICLE11 shallpayanyandalltaxesleviedonsuchpayment.APartymakingapaymentpursuanttothis ARTICLE 11 shall make a reasonable effort to obtain the lowest tax rate under ApplicableLaws for taxes required to be deducted and withheld. If Applicable Laws require that  taxesbe deducted and withheld from a payment made pursuant to this ARTICLE 11, after a Partymaking apaymentmakesareasonableefforttoobtainthelowesttaxrate,theremittingPartyshall:(i) deductthosetaxesfromthepayment;(ii)paythetaxestothepropertaxingauthority;and(iii) sendevidenceoftheobligationtogetherwithproofofpaymenttotheotherPartywithinsixty

(60) days following thatpayment.

 

(c)Tax Residence Certificate. A Party receiving a payment pursuant tothis ARTICLE11shallprovidetheremittingPartyappropriatecertificationfromrelevantrevenue authoritiesthatsuchPartyisataxresidentofthatjurisdiction,ifsuchreceivingPartywishesto claimthebenefitsofanincometaxtreatytowhichthatjurisdictionisaparty.Uponthereceipt thereof, any deduction and withholding of taxes shall be made at the appropriate treaty taxrate.

 

(d)Assessment. Either Party may, at its own expense, protest anyassessment, proposed assessment, or other claim by any Governmental Authority for any additional amount oftaxes,interestorpenaltiesorseekarefundofsuchamountspaidifpermittedtodosoby Applicable Laws. The Parties shall cooperate with each other in any  protest  byproviding recordsandsuchadditionalinformationasmayreasonablybenecessaryforaPartytopursue suchprotest.

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(e)Withholding. If a Party that owes a payment under this Agreement assignsits rights and obligations to any Person and if, solely as a result of such  assignment, the withholding or deduction of tax required by Applicable Laws with respect to payments underthis Agreement is increased, then, subject to Section 11.11(f), any amount payable underthis Agreementshallbeincreasedtotakeintoaccountsuchwithheldordeductedtaxesasmaybe necessary so that, after making all required withholdings and deductions (includingwithholdings anddeductionsonamountspayableunderthisSection11.11(e)),thepayeereceivesanamount equaltothesumitwouldhavereceivedhadnosuchincreasedwithholdingordeductionbeen made.Fortheavoidanceofdoubt,ifapayeeunderthisAgreementassignsitsrightsand obligations under this Agreement, the payee shall not be entitled to any additional paymentswith respect to Taxes arising as a result of such payee'sassignment.

 

(f)Credit. To the extent a payee obtains any credit for Taxes for which ithas received a payment pursuant to Section 11.11(e) against any liability for tax in the year inwhich thereceiptistaxable,anyprecedingyears,oranysucceedingyearswithinthetermofthis Agreement, thereby reducing out-of-pocket tax payments by the Section 11.11(e)-payee insuch year or years, calculated on a "with and without" basis, the Section 11.11(e)-payee shall promptly reimburse the Section 11.11(e)-payor an amount equal to its tax savings resultingfrom such credit and the Section 11.11(e)-payee shall timely provide the Section 11.11(e)-payorwith reasonable evidence as may reasonably be requested to determine whether any amountsare subject to reimbursement pursuant to this Section11.11(f).

 

11.12Audit.EachPartywillmaintaincompleteandaccuraterecordsinsufficientdetailto permittheotherPartytoconfirmtheaccuracyofthecalculationofroyaltyandotherpayments under this Agreement. Upon reasonable prior notice, such records shall be availableduring regular business hours for a period of three (3) years from the end of the Calendar Year towhich they pertain for examination at the expense of the requesting Party, and not more often thanonce eachCalendarYear,byanindependentcertifiedpublicaccountantselectedbytherequesting Party and reasonably acceptable to the other Party, for the sole purpose of verifying theaccuracy ofthefinancialreportsfurnishedbytheotherPartypursuanttothisAgreement.Anysuch auditorshallnotdisclosetheotherParty’sConfidentialInformation,excepttotheextentsuch disclosure is necessary to verify the accuracy of the financial reports furnished by the otherParty ortheamountofpaymentsduebytheotherPartyunderthisAgreementduringthepriorthirty six (36) months. Any amounts shown to be owed but unpaid shall be paid within thirty (30)days fromtheaccountant’sreport,plusinterest(assetforthinSection11.13)fromtheoriginaldue date. Any amounts shown to have been overpaid shall be refunded within thirty (30) daysfrom theaccountant’sreport.TherequestingPartyshallbearthefullcostofsuchauditunlesssuch auditdisclosesanunderpaymentbyotherPartyofmorethanfivepercent(5%)oftheamount due, in which case the other Party shall bear the full cost of suchaudit.

 

11.13MannerofPayment,LatePayment.AllpaymentsduetoaPartyhereundershallbe made in U.S. Dollars by wire transfer of immediately available funds into an accountdesignated bysuchParty.IfaPartydoesnotreceivepaymentofanysumduetoitonorbeforethedue date, simple interest shall thereafter accrue on the sum due to such Party until the  dateof paymentattheperannumrateofonepercent(1%)overthethen-currentprimeratequotedby

 

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CitibankinNewYorkCityorthemaximumrateallowablebyApplicableLaws,whicheveris lower.

 

11.14Finance and Accounting Working Group. The Parties shall cooperate with eachother toachievethefinanceandaccountingobjectivescontemplatedhereininatimely,accurateand responsive manner. The Parties shall establish a finance and accounting working groupto managefinancialandaccountingaffairsrelatedtotheProducts,which,foratleastthefirst twelve (12) months after the Effective Date, shall meet monthly unless otherwise agreed uponby theParties.

 

ARTICLE 12  – INTELLECTUAL PROPERTYMATTERS

 

12.1Ownership of Inventions.

 

(a)SoleOwnership.SubjecttothetermsofthisAgreement,eachPartyshallown any Inventions made solely by its own employees, agents, or independent contractors orits Affiliate’s or sublicensees’ employees, agents, or independent contractors in the courseof conducting its activities under this Agreement, together with all intellectual propertyrights therein.

 

(b)Joint Ownership. The Parties shall jointly own any Inventions that aremade jointlybyemployees,agents,orindependentcontractorsofeachPartyoritsAffiliatesinthe courseofperformingactivitiesunderthisAgreement,togetherwithallintellectualproperty rights therein (the “JointInventions”).

 

(c)Inventorship. For purposes of this Agreement, inventorship shall bedetermined in accordance with U.S. patent laws.

 

|   | 12.2 | Assignment Obligation and Disclosure ofInventions. |   |
|--------|------|----------------------------------------------------|--------|

 

(a)Each Party shall cause all Persons who perform activities for such Party underthis Agreement to be under an obligation to assign (or, if such Party is unable to cause such Personto agree to such assignment obligation despite such Party using commercially reasonable effortsto negotiate such assignment obligation, provide a license under) their rights in any Informationand InventionsresultingtherefromtosuchParty,exceptwhereApplicableLawrequiresotherwise and except in the case of governmental, not-for-profit and public institutions which have standard policies against such an assignment (in which case a suitable license, or right toobtain such a license, shall beobtained).

 

(b)Takeda will promptly disclose to Ultragenyx in writing, theconception, discovery, development or making of any Joint Inventions and any InventionsCovering Ultragenyx Pipeline Improvements by Persons who perform activities for Takeda underthis Agreement.

 

 

 

 

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(c)Ultragenyx will promptly disclose to Takeda in writing the conception,discovery, developmentormakingofanyJointInventionsandanyInventionsCoveringLicensedProduct Improvements, or Option ProductImprovements.

 

(d)Each Party will promptly disclose to the other Party in writing, theconception, discovery, development or making of any Joint Inventions by Persons who perform activitiesfor it under thisAgreement.

 

|   | 12.3 | Prosecution of Patents. |   |
|--------|------|-------------------------|--------|

 

(a)Licensed [***] Patents, Licensed Product Improvement Patents, andJoint Patents relating to Licensed Products. Except as otherwise provided in this Section 12.3(a),as between the Parties, Takeda shall have the sole right and authority to prepare, file, prosecuteand maintain the Licensed [***] Patent, Licensed Product Improvement Patents, and, where relatingto LicensedProducts,JointPatents(collectively,the“[***]PatentProsecution”)onaworldwide basis (including the right to defend in patent office proceedings such as inter partes reviews,post grant reviews and oppositions).Takeda shall bear all costs of preparation, filing, prosecutionand maintenanceofthe[***]PatentProsecutionintheTerritory.ProvidedthatUltragenyx’srights with respect to the applicable Licensed Product have not terminated, Takeda, uponUltragenyx’s request,shallprovideUltragenyxareasonableopportunitytoreviewandcommentonmaterial communications from any patent authority in the Territory regarding the [***] PatentProsecution and drafts of any material filings or responses to be made to such patent authorities in advanceof submitting such filings or responses. Takeda shall consider Ultragenyx’s commentsregarding suchcommunicationsanddraftsingoodfaithwithaviewtomaximizingthePatentprotection andscopeintheTerritoryintheUltragenyxField.IfUltragenyx’srightswithrespecttothe applicable Licensed Product have not terminated and Takeda determines in its sole discretionto abandonornotmaintainanyLicensed[***]Patent,LicensedProductImprovementPatent,or, where relating to Licensed Products, Joint Patent that is being prosecuted or maintainedby TakedaintheTerritoryandthatisapplicabletotheintheUltragenyxField,thenTakedashall provide Ultragenyx with written notice of such determination within a period of timereasonably necessarytoallowUltragenyxtodetermine,initssolediscretion,itsinterestinsuchPatent(s) (which notice by Takeda shall be given no later than sixty (60) days prior to the final deadlinefor any pending action or response that may be due with respect to such Patent(s) with theapplicable patent authority). If Ultragenyx provides timely written notice expressing its interestin continuingtosupportsuchPatent(s),Ultragenyxshallhavetherighttopursuethefilingor supportthecontinuedprosecutionormaintenanceofsuchPatentsandTakedashallprovideto Ultragenyx,subjecttoreimbursementofTakeda’sout-of-pocketcosts,allunpublishedpatent applicationsandanyotherinformationanddocumentsnecessarytopermitUltragenyxtotake such action to establish or preserve any such Patents. If Ultragenyx pursues the filing orsupport ofsuchPatentsandTakedacontinuestopursueaLicensed[***]ProductintheTakedaField,it shall provide Takeda a reasonable opportunity to review and comment onmaterial communicationsfromanypatentauthorityintheTerritoryregardingsuchPatentsanddraftsof anymaterialfilingsorresponsestobemadetosuchpatentauthoritiesinadvanceofsubmitting such filings or responses. Ultragenyx shall consider Takeda’s comments regardingsuch communications and drafts in goodfaith.

 

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(b)Option Product Patents, Option Product Improvement Patents, andJoint Patents Relating to Research Products. Except as otherwise provided in this Section 12.3(b), asbetweentheParties,Takedashallhavethesolerightandauthoritytoprepare,file,prosecute and maintain the Option Product Patents, Option Product Improvement Patents and,where relatingtoResearchProducts,JointPatentsonaworldwidebasis(includingtherighttodefend inpatentofficeproceedingssuchasinterpartesreviews,postgrantreviewsandoppositions). Takeda shall bear all costs of preparation, filing, prosecution and maintenance of OptionProduct Patents,OptionProductImprovementPatentsand,whererelatingtoResearchProducts,Joint PatentsintheTerritory.DuringtheCollaborationTerm,Takeda,uponUltragenyx’srequest, shall provide Ultragenyx a reasonable opportunity to review and comment onmaterial communications from any patent authority in the Territory regarding Option ProductPatents, Option Product Improvement Patents and, where relating to Research Products, Joint Patentsand draftsofanymaterialfilingsorresponsestobemadetosuchpatentauthoritiesinadvanceof submitting such filings or responses. Takeda shall consider Ultragenyx’s commentsregarding suchcommunicationsanddraftsingoodfaithwithaviewtomaximizingthePatentprotection andscopeintheTerritoryintheLicensedField;providedthatfinaldecisionmakingauthority rests with Takeda. If, during the Collaboration Term, Takeda determines in its sole discretionto abandonornotmaintainanyOptionProductPatent,OptionProductImprovementPatentand, where relating to Research Products, Joint Patent that is being prosecuted or maintainedby Takeda in the Territory, then Takeda shall provide Ultragenyx with written notice ofsuch determination within a period of time reasonably necessary to allow Ultragenyx to determine,in itssolediscretion,itsinterestinsuchPatent(s)(whichnoticebyTakedashallbegivennolater thansixty(60)dayspriortothefinaldeadlineforanypendingactionorresponsethatmaybe duewithrespecttosuchPatent(s)withtheapplicablepatentauthority).IfUltragenyxprovides timelywrittennoticeexpressingitsinterestincontinuingtosupportsuchPatent(s),Ultragenyx shallhavetherighttopursuethefilingorsupportthecontinuedprosecutionormaintenanceof such Patents and Takeda shall provide to Ultragenyx, subject to reimbursement of Takeda’sout- of-pocketcosts,allunpublishedpatentapplicationsandanyotherinformationanddocuments necessary to permit Ultragenyx to take such action to establish or preserve any such Patents.If UltragenyxpursuesthefilingorsupportofsuchPatents,itshallprovideTakedaareasonable opportunity to review and comment on material communications from any patent authority inthe Territory regarding such Patents and drafts of any material filings or  responses to be madeto suchpatentauthoritiesinadvanceofsubmittingsuchfilingsorresponses.Ultragenyxshall consider Takeda’s comments regarding such communications and drafts in goodfaith. Notwithstanding the foregoing, following the execution of an Option Product LicenseAgreement and/orExercisedProductLicenseAgreementcoveringanOptionProduct,thetermsofsuch license agreement(s) shall govern the handling of the preparation, filing, prosecutionand maintenance of Patents covering the OptionProduct(s).

 

(c)Ultragenyx Pipeline Patents, Ultragenyx Pipeline ImprovementPatents, Ultragenyx [***] Patents and Joint Patents Related to Ultragenyx Pipeline Products.Except asotherwiseprovidedinthisSection12.3(c),asbetweentheParties,Ultragenyxshallhavethe sole right and authority to prepare, file, prosecute and maintain the Ultragenyx PipelinePatents, Ultragenyx Pipeline Improvement Patents, Ultragenyx [***] Patents and, where relatingto UltragenyxPipelineProducts,thePatentsincludedintheJointInventions(the“JointPatents”),

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on a worldwide basis (including the right to defend in patent office proceedings such asinter partes reviews, post grant reviews and oppositions). Ultragenyx shall bear all costs of preparation, filing, prosecution and maintenance of Ultragenyx Pipeline Patents,Ultragenyx Pipeline Improvement Patents, Ultragenyx [***] Patents and, where relating to Ultragenyx Pipeline Products, Joint Patents in the Territory. During the Takeda Option Term, Ultragenyx, upon Takeda’s request, shall provide Takeda a reasonable opportunity to review and commenton material communications from any patent authority in the Territory regardingUltragenyx Pipeline Patents, Ultragenyx Pipeline Improvement Patents, Ultragenyx [***] Patents and,where relating to Ultragenyx Pipeline Products, Joint Patents and drafts of any material filingsor responses to be made to such patent authorities in advance of submitting such filingsor responses. Ultragenyx shall consider Takeda’s comments regarding such communicationsand draftsingoodfaithwithaviewtomaximizingthePatentprotectionandscopeintheTerritory; provided that final decision making authority rests with Ultragenyx. During the TakedaOption Term, if Ultragenyx determines in its sole discretion to abandon or not maintain anyUltragenyx PipelinePatent,UltragenyxPipelineImprovementPatent,Ultragenyx[***]Patentand,where relatingtoUltragenyxPipelineProducts,JointPatentthatisbeingprosecutedormaintainedby Ultragenyx in the Takeda Territory, then Ultragenyx shall provide Takeda with written noticeof suchdeterminationwithinaperiodoftimereasonablynecessarytoallowTakedatodetermine, in its sole discretion, its interest in such Patent(s) (which notice by Ultragenyx shall be givenno later than sixty (60) days prior to the final deadline for any pending action or response thatmay beduewithrespecttosuchPatent(s)withtheapplicablepatentauthority).IfTakedaprovides timely written notice expressing its interest in continuing to support such Patent(s), Takedashall havetherighttopursuethefilingorsupportthecontinuedprosecutionormaintenanceofsuch PatentsandUltragenyxshallprovidetoTakeda,subjecttoreimbursementofUltragenyx’sout- of-pocketcosts,allunpublishedpatentapplicationsandanyotherinformationanddocuments necessary to permit Takeda to take such action to establish or preserve any such Patents.If Takeda pursues the filing or support of such Patents, it shall provide Ultragenyx areasonable opportunity to review and comment on material communications from any patent authority inthe TerritoryregardingsuchPatentsanddraftsofanymaterialfilingsorresponsestobemadeto such patent authorities in advance of submitting such filings or responses. Takeda shallconsider Takeda’s comments regarding such communications and drafts in good faith.Notwithstanding the foregoing, following the execution of an Exercised Product License Agreement coveringan UltragenyxPipelineProduct,thetermsofsuchlicenseagreementshallgovernthehandlingof the preparation, filing, prosecution and maintenance of Patents covering such Ultragenyx PipelineProduct.

 

(d)Cooperation in Prosecution. Each Party shall provide the other Partyall reasonableassistanceandcooperationinthePatentprosecutioneffortsprovidedaboveinthis Section 12.3, including providing any necessary powers of attorney and executing anyother requireddocumentsorinstrumentsforsuchprosecution,aswellasfurtheractionsassetforth below.

 

(i)The Parties shall respectively prepare, file, maintain and prosecutethe PatentsassetforthinthisSection12.3.Asusedherein,“prosecution”ofsuchPatentsshall

 

 

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include all communication and other interaction with any patent office or patent authorityhaving jurisdiction over a patent application in connection with pre-grantproceedings.

 

(ii)All communications between the Parties relating to the preparation,filing, prosecutionormaintenanceofthePatentsassetforthinthisSection12.3,includingcopiesof anydraftorfinaldocumentsoranycommunicationsreceivedfromorsenttopatentofficesor patentingauthoritieswithrespecttosuchPatents,shallbeconsideredConfidentialInformation and subject to the confidentiality provisions of ARTICLE14.

 

|   | 12.4 | Patent Term Extensions in theTerritory. |
|--------|------|-----------------------------------------|

 

(a)ThePartieswilldiscussandapproveforwhich,ifany,ofthePatentsunderthis AgreementthePartiesshouldseekPatentTermExtensionsintheTerritory.IfthePartiesare unable to reach agreement for which, if any, of such Patents the Parties should seek PatentTerm Extension, the final decision shall rest with the Party who first receives Regulatory Approvalfor theLicensedProductorOptionProduct,asapplicable,withrespecttowhichthePatentTerm applies for such Party’s territory. The Party with final decision-making authority shall actwith reasonablepromptnessinlightofthestageoftheProductstoapplyforanysuchPatentTerm Extensions,inaccordancewithsuchdecision.ThePartythatdoesnotapplyforanextension hereunderwillcooperatefullywiththeotherPartyinmakingsuchfilingsoractions,including making available all required Regulatory Materials (including underlying data) andInformation and executing any required authorizations to apply for such Patent Term Extension. All expensesincurredinconnectionwithactivitiesofeachPartywithrespecttothePatent(s)for whichsuchPartyseeksPatentTermExtensionspursuanttothis12.4shallbeentirelyborneby the Party applying for such Patent TermExtension.

 

12.5Orange Book Listing. The Party that is the NDA holder for the applicable Productshall beresponsibleforlistingandmaintainingallapplicablePatentsintheOrangeBook,including payment of all costs and expenses related to such maintenance incurred after the EffectiveDate. The listing and maintaining Party shall provide the other Party with its planned  listingsin advance of their submission with sufficient time for the other Party to review andprovide comments.ThelistingandmaintainingPartyshallconsideranysuchcommentsingoodfaith. Upon request of the listing and maintaining Party, the other Party shall cooperate in the filingof appropriate information with the FDA listing such Patents in the OrangeBook.

 

|   | 12.6 | Infringement of Patents by Third Parties. |
|--------|------|-------------------------------------------|

 

(a)Notification. Each Party shall promptly notify the other Party in writing ofany existing, alleged or threatened infringement of the Licensed [***] Patents, LicensedProduct Improvement Patents, Ultragenyx [***] Patents, Option Product Patents, OptionProduct Improvement Patents, Ultragenyx Pipeline Patents, Ultragenyx Pipeline ImprovementPatents, andJointPatentsintheLicensedFieldintheTerritoryofwhichitbecomesaware,andshall provide all Information in such Party’s possession or control demonstrating suchinfringement.

 

(b)InfringementAction.

 

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(i)Takeda shall have the first right, but not the obligation, to bringan appropriatesuitorotheractionagainstanyThirdPartyengagedinanyexisting,allegedor threatenedinfringementrelatedtotheJointPatents,Licensed[***]Patents,LicensedProduct Improvement Patents, Ultragenyx [***] Patents, Option Product Patents, and OptionProduct Improvement Patents, in each case where relating to Licensed Products or Research Products(a “Takeda Product Infringement”), subject to Section 12.6(b)(ii) through 12.6(b)(iv); providedthat ifaTakedaProductInfringementconcernstheenforcementofanyValidClaimagainstaThird Partymaking,using,selling,offeringforsale,orimportingsolelywithintheUltragenyxField, Takeda must receive Ultragenyx’s prior consent with respect to all strategic decisionsin connection with such Takeda Product Infringement, such consent not to beunreasonably withheld,conditioned,ordelayed;andprovidedfurtherthatifTakedaisnotDevelopingor CommercializingtheLicensed[***]ProductintheTakedaField,thentheforegoingfirstright withrespecttoaTakedaProductInfringementshallbecomeUltragenyx’sfirstrighthereunder. Ultragenyxshallhavethefirstright,butnottheobligation,tobringanappropriatesuitorother action against any Third Party engaged in any existing, alleged or  threatenedinfringement relatedtotheJointPatents,UltragenyxPipelinePatentsandUltragenyxPipelineImprovement Patents, in each case where relating to an Ultragenyx Pipeline Product (an “UltragenyxProductInfringement”), subject to Section 12.6(b)(ii) through 12.6(b)(iv).  Notwithstandingthe foregoing, following the execution of an Option Product License Agreement or Exercised Product License Agreement, the terms of such license agreement shall govern the handling ofthe infringement actions relating to the Patents covering such Licensed Option Product orExercised Product, respectively, that is the subject of such licenseagreement.

 

(ii)The Parties shall discuss how to address each Takeda Product InfringementandUltragenyxProductInfringementandthePartywiththefirstrighttoenforce shallconsideringoodfaiththeinputoftheotherPartyindetermininghowtoproceed.The Party with the first right to enforce shall notify the other Party of its election to take any actionin accordance with Section 12.6(b)(i) within ten (10) Business Days before any time limit setforth in an Applicable Laws or regulation, including the time limits set forth under the HatchWaxman Act. In the event such Party does not so elect, it shall so notify the other Party in writing, andthe other Party shall have the right to commence a suit or take action to enforce the applicablePatent against such Third Party perpetrating such Takeda Product Infringement or UltragenyxProduct Infringement, as applicable, in the applicable portion of the Territory at its own cost andexpense. IfonePartyelectstobringsuitortakeactionagainsttheTakedaProductInfringementor UltragenyxProductInfringement,asapplicable,thentheotherParty(atitsexpense)shallhave the right, prior to commencement of the trial, suit or action, to join any such suit oraction.

 

(iii)Each Party shall provide to the Party enforcing any such rights underthis Section 12.6(b) reasonable assistance in such enforcement, at such enforcing Party’s requestand expense,includingjoiningsuchactionasapartyplaintiffifrequiredbyApplicableLawsto pursuesuchaction.TheenforcingPartyshallkeeptheotherPartyregularlyinformedofthe statusandprogressofsuchenforcementeffortsandshallreasonablyconsidertheotherParty’s commentsonanyimportantaspectsofsuchenforcement,includingdeterminationoflitigation strategy and filing of important papers to the competentcourt.

 

 

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(iv)Subject to this Section 12.6(b)(iv), the enforcing Party shall besolely responsible for all costs and expenses arising from a suit or action against a TakedaProduct Infringement or Ultragenyx Product Infringement, as applicable. For the avoidance of doubt,the enforcing Party shall not be responsible for the other Party’s internal costs (e.g., FTEs)incurred asaresultoftheotherParty’scooperationwiththeenforcementactionasprovidedinSection 12.6(b)(iii). The Party not bringing an action with respect to the Takeda Product Infringementor Ultragenyx Product Infringement, as applicable, under this Section 12.6(b) shall be entitledto separaterepresentationinsuchmatterbycounselofitsownchoiceandatitsownexpense,but such Party shall at all times cooperate fully with the Party bringing suchaction.

 

(c)Settlement.TheenforcingPartymaysettleanyclaim,suitoractionthatithas brought under this Section 12.6 without the prior written consent of the other Party; providedthat anysuchsettlementdoesnotnegativelyimpactthenon-enforcingParty’srightsorinterestsin such non-enforcing Party’s territory orfield.

 

(d)Allocation of Proceeds. If either Party recovers monetary damages fromany Third Party in a suit or action brought under Sections 12.6(b), 12.6(c), or 12.8(b) or anyroyalties from a license agreement with a Third Party related to any alleged Takeda ProductInfringement orUltragenyxProductInfringement,asapplicable,suchrecoveryshallbeallocatedfirsttothe reimbursement of any expenses incurred by the Parties in such suit or action, and any remaining amounts shall be split as follows: (i) if such suit or action is initiated or defended byUltragenyx, suchamountsshallberetainedbyUltragenyx,or(ii)ifsuchsuitoractionwasinitiatedor defended by Takeda, such amounts shall be retained byTakeda.

 

|   | 12.7 | Infringement of Third Party Rights in theTerritory. |   |
|--------|------|-----------------------------------------------------|--------|

 

(a)Notice. If any Licensed Product used or sold by either Party, itsAffiliates, licenseesorsublicenseesbecomesthesubjectofaThirdParty’sclaimorassertionof infringement of a Patent granted in either Party’s field or territory, the Party first having noticeof theclaimorassertionshallpromptlynotifytheotherParty,thePartiesshallagreeonandenter into an “identity of interest agreement” wherein such Parties agree to their  shared,mutual interestintheoutcomeofsuchpotentialdispute,andthereafter,thePartiesshallpromptlymeet to consider the claim or assertion and the appropriate course ofaction.

 

(b)Defense.

 

(i)Ultragenyx shall have the first right, but not the obligation, to defendany Third Party claim or assertion of infringement of a Patent described in Section 12.7(a) aboveby Ultragenyx Pipeline Products, at Ultragenyx’s expense. If Ultragenyx does not commence actionstodefendsuchclaimwithinthirty(30)daysafteritreceivesnoticethereof(orwithin thirty (30) days after it should have given notice thereof to Takeda as required bySection 12.7(a)), then, to the extent allowed by Applicable Laws, Takeda shall have the right, but not the obligation,tocontrolthedefenseofsuchclaimbycounselofitschoice,atTakeda’sexpense. The non-defending Party shall reasonably cooperate with the Party conducting the defense ofthe claim or assertion, including if required to conduct such defense, furnishing a power ofattorney.

 

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(ii)Takedashallhavethefirstright,butnottheobligation,todefendany Third Party claim or assertion of infringement of a Patent described in Section 12.7(a) aboveby Licensed [***] Products, Licensed Analog Products, Candidate Products or Option Products,at Takeda’s expense. If Takeda does not commence actions to defend such claim within thirty(30) daysafteritreceivesnoticethereof(orwithinthirty(30)daysafteritshouldhavegivennotice thereoftoUltragenyxasrequiredbySection12.7(a)),then,totheextentallowedbyApplicable Laws, Ultragenyx shall have the right, but not the obligation, to control the defense of suchclaim bycounselofitschoice,atUltragenyx’sexpense.Thenon-defendingPartyshallreasonably cooperate with the Party conducting the defense of the claim or assertion, including if requiredto conduct such defense, furnishing a power ofattorney.

 

(iii)Notwithstanding the foregoing, following the execution of anOption Product License Agreement or Exercised Product License Agreement, the terms of suchlicense agreementshallgovernthehandlingofthedefenseagainstinfringementbyProduct(s)thatare the subject of the applicable licenseagreement.

 

(c)Settlement; Licenses. Neither Party shall enter into any settlement of anyclaim described in this Section 12.7 that negatively affects the other Party’s rights or interestswithout such other Party’s written consent, which consent shall not be unreasonablywithheld, conditioned or delayed. Each Party shall have the right to decline to defend or to tenderdefense ofanysuchclaimtotheotherPartyuponreasonablenotice,includingiftheotherPartyfailsto agree to a settlement that such Party proposes. In the event that it is determined by any courtof competent jurisdiction that the Exploitation of a Product in the Licensed Field in theUltragenyx Territory, conducted in accordance with the terms and conditions of this Agreement, infringes,or theJSCdeterminesthatsuchactivitiesarelikelytoinfringe,anypatent,copyright,trademark, data exclusivity right or trade secret right arising under Applicable Laws of any ThirdParty, Ultragenyx shall use Commercially Reasonable Efforts to: (i) procure a license from suchThird Party authorizing Ultragenyx to continue to conduct such activities; or (ii) modify suchactivities so as to render itnon-infringing.

 

|   | 12.8 | Patent Oppositions and OtherProceedings. |   |
|--------|------|------------------------------------------|--------|

 

(a)Third-Party Patent Rights. If either Party desires to bring an opposition,action for declaratory judgment, nullity action, interference, declaration fornon-infringement, reexaminationorotherattackuponthevalidity,titleorenforceabilityofaPatentownedor controlled by a Third Party and having one or more claims that covers a Product, or the use,sale, offerforsaleorimportationofaProduct(exceptinsofarassuchactionisacounterclaimtoor defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringementunder Section12.7,inwhichcasetheprovisionsofSection12.7shallgovern),suchPartyshallso notifytheotherPartyandthePartiesshallpromptlyconfertodeterminewhethertobringsuch actionorthemannerinwhichtosettlesuchaction.Ultragenyxshallhavetheexclusiveright, butnottheobligation,tobringatitsownexpenseandinitssolecontrolsuchactioninthe Territory with respect to Ultragenyx Pipeline Products. Takeda shall have the exclusive right,but nottheobligation,tobringatitsownexpenseandinitssolecontrolsuchactionwithrespectto Licensed [***] Products, Licensed Analog Products and Research Products in the Territory. Ifthe

 

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Partywiththefirstrightdoesnotbringsuchanaction,withinninety(90)daysofnotification thereofpursuanttothisSection12.8(a)(orearlier,ifrequiredbythenatureoftheproceeding), then the other Party shall have the right, but not the obligation, to bring, at its sole expense,such action. The Party not bringing an action under this Section 12.8(a) shall be entitled toseparate representation in such proceeding by counsel of its own choice and at its own expense, andshall cooperate fully with the Party bringing such action. Any awards or amounts received inbringing any such action shall be first allocated to reimburse the initiating Party’s expenses in suchaction and any remaining amounts shall be retained by suchParty.

 

(b)Parties’ Patent Rights. If any Licensed [***] Patents, LicensedProduct Improvement Patent, Ultragenyx [***] Patents, Option Product Patent, OptionProduct ImprovementPatent,UltragenyxPipelinePatent,UltragenyxPipelineImprovementPatent,or JointPatentbecomesthesubjectofanyproceedingcommencedbyaThirdPartywithinthe Territory in connection with an opposition, reexamination request, action fordeclaratory judgment,nullityaction,interferenceorotherattackuponthevalidity,titleorenforceability thereof(exceptinsofarassuchactionisacounterclaimtoordefenseof,oraccompaniesa defense of, an action for infringement against a Third Party under Section 12.6, in which casethe provisions of Section 12.6 shall govern), then the Party responsible for filing,preparing, prosecuting and maintaining such Patent as set forth in Section 12.3, shall control such defenseat its own cost and expense. The controlling Party shall permit the non-controlling Partyto participate in the proceeding to the extent permissible under Applicable Laws, and tobe represented by its own counsel in such proceeding, at the non-controlling Party’s expense. Ifthe controlling Party decides that it does not wish to defend against such action, then the otherParty shall have a backup right to assume defense of such Third-Party action at its own expense.Any awards or amounts received in defending any such Third-Party action shall be allocatedbetween the Parties as provided in Section12.6(d).

 

ARTICLE 13  – REPRESENTATIONS ANDWARRANTIES

 

13.1Mutual Representations, Warranties and Covenants. Each of the Partieshereby represents and warrants to the other Party as of the Execution Date and covenantsthat:

 

(a)Organization. It is a corporation duly organized, validly existing, and ingood standingunderthelawsofthejurisdictionofitsorganization,andhasallrequisitepowerand authority, corporate or otherwise, to execute, deliver, and perform thisAgreement.

 

(b)BindingAgreement.ThisAgreementisalegalandvalidobligationbinding upon such Party and enforceable in accordance with its terms, subject to the effectsof bankruptcy, insolvency, or other laws of general application affecting the enforcement ofcreditor rights, judicial principles affecting the availability of specific performance,  andgeneral principles of equity (whether enforceability is considered a proceeding at law orequity).

 

(c)Authorization. The execution, delivery, and performance of this Agreementby suchPartyhavebeendulyauthorizedbyallnecessarycorporateactionanddonotconflictwith any agreement, instrument, or understanding, oral or written, to which it is a party or by whichit isbound,norviolateanyApplicableLawsoranyorder,writ,judgment,injunction,decree,

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determination,orawardofanycourtorgovernmentalbody,oradministrativeorotheragency presently in effect applicable to suchParty.

 

(d)No Further Approval. Subject to Section 18.1, it is not aware  of any government authorization, consent, approval, license, exemption of or filing or registrationwith anycourtorgovernmentaldepartment,commission,board,bureau,agencyorinstrumentality, domestic or foreign, under any Applicable Laws, currently in effect, necessary for, orin connectionwith,thetransactionscontemplatedbythisAgreementoranyotheragreementor instrument executed in connection herewith, or for the performance by it of its obligationsunder this Agreement and such other agreements (save for Regulatory Approvals andsimilar authorizations from Regulatory Authorities necessary for the Exploitation of the Compoundsand the Products as contemplatedhereunder).

 

(e)No Inconsistent Obligations. Neither Party is under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect withthe termsofthisAgreement,orthatwouldimpedethediligentandcompletefulfillmentofits obligationshereunder.

 

(f)Transparency Reporting. Each Party shall be responsible for trackingand reporting transfers of value initiated and controlled by its and its Affiliates’employees, independent contractors, and agents pursuant to the requirements of the marketing reportinglaws ofanyGovernmentAuthorityintheTerritory,includingSection6002ofthePatientProtection and Affordable Care Act, commonly referred to as the “SunshineAct.”

 

(g)Neither Party nor any of its Affiliates has been debarred by the FDA, is subjectto any similar sanction of other Regulatory Authorities in the Territory, and neither Party nor anyof its Affiliates has used, or will engage, in any capacity, in connection with this Agreement orany ancillaryagreements(ifany),anyPersonwhoeitherhasbeendebarredbysuchaRegulatory Authority,oristhesubjectofaconvictiondescribedinSection306oftheFFDCA.EachParty shall inform the other in writing promptly if it or any Person engaged by such Party or any ofits Affiliates who is performing services under this Agreement or any ancillary agreements (ifany) isdebarredoristhesubjectofaconvictiondescribedinSection306oftheFFDCA,orifany action,suit,claim,investigationorlegaloradministrativeproceedingispendingor,tosuch Party’sKnowledge,isthreatened,relatingtothedebarmentorconvictionofsuchParty,anyof its Affiliates or any such Person performing services hereunder orthereunder.

 

13.2Additional   Representations,   Warranties   and   Covenants   of  Takeda.Takeda represents and warrants as of the Execution Date and covenants to Ultragenyxthat:

 

(a)Takeda has all rights necessary to grant the options and licenses underthe Licensed[***]TechnologyandOptionProductTechnologyandrightsofcross-referenceunder Regulatory Materials, in each case, existing as of the Execution Date that it grants toUltragenyx inthisAgreement.ForthedurationoftheTerm,Takedashallnot,andshallcauseitsAffiliates not to, grant to any Third Party rights in the Licensed Field or the Ultragenyx Field,as applicable, in the Territory that encumber, diminish or conflict with the rights grantedto

 

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Ultragenyx hereunder with respect to the Licensed [***] Technology, Option ProductTechnology, Joint Intellectual Property or RegulatoryMaterials.

 

(b)(i)ThePatentssetforthinExhibit1.168representallTakedaPatents,(ii)to Takeda’s Knowledge, the Compounds set forth in Exhibit 13.2(b) represent allstructures ControlledbyTakedathatare[***],and

(i)to Takeda’s Knowledge, the Compound set forth in Exhibit 1.94 represents the soleLicensed [***] Compound. Takeda (Y) is the sole and exclusive owner of the entire right, title and interest in the Takeda Patents, and (Z) to Takeda’s Knowledge, the sole and exclusive owner of theentire right, title and interest in the Licensed [***] Compound and Licensed Analog Compounds, andin eachofcases(Y)and(Z),freeofanyencumbrance,lien,orclaimofownershipbyanyThird Party.

 

(c)To Takeda’s Knowledge, there is no actual or threatened infringementor misappropriation of the Licensed [***] Technology and Option Product Technology by any Person in theTerritory.

 

(d)The Takeda Patents are being diligently prosecuted in the Territory inaccordance with Applicable Laws. To Takeda’s Knowledge, the Takeda Patents have been filedand maintainedproperlyandcorrectlyandallapplicablefeeshavebeenpaidonorbeforethedue date forpayment.

 

(e)To Takeda’s Knowledge, each of the Takeda Patents properly identifies eachand everyinventoroftheclaimsthereofasdeterminedinaccordancewithApplicableLawsofthe jurisdiction in which such Takeda Patent is issued or such application ispending.

 

(f)To the extent permissible under Applicable Laws, all employees of Takeda orits AffiliatesperformingactivitiesunderthisAgreementareandshallbeunderanobligationto assign all right, title and interest in and to their Inventions and intellectual property rightstherein, toTakedaoritsAffiliate(s)asthesoleownerthereof.Ultragenyxshallhavenoobligationto contribute to any remuneration of any inventor employed or previously employed by Takedaor any of its Affiliates in respect of any such Inventions and intellectual property rights thereinthat aresoassignedtoTakedaoritsAffiliate(s).Takedawillpayallsuchremunerationduetosuch inventors with respect to such Inventions and intellectual property rightstherein.

 

(g)The Inventions claimed or disclosed by the Takeda Patents (i) were not conceived, discovered, developed, or otherwise made in connection with any researchactivities funded, in whole or in part, by the federal government of the U.S. or any agency thereof, (ii)are nota“subjectinvention”asthattermisdescribedin35U.S.C.Section201(f),and(iii)arenot otherwise subject to the provisions of the Bayh-DoleAct.

 

(h)To Takeda’s Knowledge, there are no material claims, judgments, orsettlements against,oramountswithrespectthereto,owedbyTakedaoranyofitsAffiliatestoanyThird Parties relating to the Regulatory Materials, Licensed [***] Technology or OptionProduct Technology in theTerritory.

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(i)No claim or litigation in the Territory has been brought or, toTakeda’s Knowledge, threatened by any Person alleging, and Takeda has no Knowledge of anyclaim, whether or not asserted: (i) that any of the Takeda Patents is invalid or unenforceable, (ii) thatthe Regulatory Materials, or the disclosing, copying, making, assigning, or licensing ofthe Regulatory Materials, violates, infringes, or otherwise conflicts or interferes with, orwould violate,infringe,orotherwiseconflictorinterferewith,anyintellectualpropertyorproprietary rightofanyPerson;or(iii)relatedtotheDevelopmentorCommercializationoftheLicensed Products or Research Products, including any claims of ProductLiability.

 

(j)Takeda has no Knowledge of any material adverse information with respect tothe safetyandefficacyofanyLicensedProductorResearchProductthathasnotbeendisclosedto Ultragenyx, and all such information that has been disclosed is true, correct, and complete inall materialrespects.

 

(k)To Takeda’s Knowledge, Takeda and its Affiliates have generated,prepared, maintained, and retained all material Regulatory Materials in the Licensed Field that arerequired to be maintained or retained pursuant to and in accordance with GCP, GLP and otherApplicable Laws,andallsuchinformationistrue,completeandcorrectinallmaterialrespectsandwhatit purports to be.

 

(l)Takeda, without the prior written consent of Ultragenyx, during the Term, willnot solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employeeof Ultragenyx, or any of its Affiliates, to terminate his or her relationship with Ultragenyxor Ultragenyx’s Affiliate. An offer of employment to an employee of Ultragenyx by Takedawhich results directly from unsolicited responses to general advertisements for employment will notbe deemed to be in violation of thisprovision.

 

(m)In performing its obligations under this Agreement, Takeda shall, and shallcause its Affiliates to, comply with all Applicable Laws, including any applicable anti-corruptionor anti-bribery laws or regulation, of any Governmental Authority with jurisdiction overthe activities performed by Takeda or its Affiliates in furtherance of suchobligations.

 

13.3Additional Representations, Warranties and Covenants of Ultragenyx.Ultragenyx represents and warrants as of the Execution Date and covenants to Takedathat:

 

(a)Ultragenyx and its Affiliates have provided or made available to Takeda priorto the Execution Date, true, complete, and correct copies (as of the Execution Date) ofall Ultragenyx In-LicenseAgreements.

 

(b)Ultragenyxhasallrightsapplicablenecessarytogranttheoptionsandlicenses under the Ultragenyx Intellectual Property and rights of cross-reference underRegulatory Materials, in each case, that it grants to Takeda in this Agreement. For the duration of theTerm, Ultragenyxshallnot,andshallcauseitsAffiliatesnotto,granttoanyThirdPartyrightsinthe TakedaFieldintheTerritoryortheLicensedFieldintheTakedaTerritory,asapplicable,that encumber,diminishorconflictwiththerightsgrantedtoTakedahereunderwithrespecttothe Ultragenyx Intellectual Property, Joint Intellectual Property or RegulatoryMaterials.

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(c)The Patents set forth in Exhibit 1.188 represent all  UltragenyxPatents. Ultragenyx is the sole and exclusive owner of the entire right, title and interest in theUltragenyx Patents free of any encumbrance, lien, or claim of ownership by any ThirdParty.

 

(d)To Ultragenyx’s Knowledge, there is no actual or threatened infringementor misappropriation of the Ultragenyx Intellectual Property by any Person in theTerritory.

 

(e)The Ultragenyx Patents are being diligently prosecuted in the Territoryin accordance with Applicable Laws and consistent with Ultragenyx’s current prosecution practices. To Ultragenyx’s Knowledge, the Ultragenyx Patents have been filed andmaintained properlyandcorrectlyandallapplicablefeeshavebeenpaidonorbeforetheduedatefor payment.

 

(f)To Ultragenyx’s Knowledge, each of the Ultragenyx Patents properlyidentifies each and every inventor of the claims thereof as determined in accordance with ApplicableLaws of the jurisdiction in which such Ultragenyx Patent is issued or such application ispending.

 

(g)To the extent permissible under Applicable Laws, all employees of Ultragenyxor its Affiliates performing activities under this Agreement shall be under an obligation to assignall right,titleandinterestinandtotheirInventions,andintellectualpropertyrightstherein,to Ultragenyx or its Affiliate(s) as the sole owner thereof. Takeda shall have no obligationto contribute to any remuneration of any inventor employed or previously employed byUltragenyx or any of its Affiliates in respect of any such inventions, Information and discoveriesand intellectual property rights therein that are so assigned to Ultragenyx or itsAffiliate(s). Ultragenyx will pay all such remuneration due to such inventors with respect to suchInventions and intellectual property rightstherein.

 

(h)To Ultragenyx’s Knowledge, the Inventions claimed or disclosed bythe Ultragenyx Patents (i) were not conceived, discovered, developed, or otherwise madein connection with any research activities funded, in whole or in part, by the federal governmentof theU.S.oranyagencythereof,(ii)arenota“subjectinvention”asthattermisdescribedin35

|   | U.S.C. | Section 201(f), and (iii) are not otherwise subject to the provisions of the Bayh-DoleAct. |   |
|--------|--------|--------------------------------------------------------------------------------------------|--------|

 

(i)To Ultragenyx’s Knowledge, there are no material claims, judgments,or settlements against, or amounts with respect thereto, owed by Ultragenyx or any of itsAffiliates to any Third Parties relating to the Regulatory Materials or the Ultragenyx IntellectualProperty in theTerritory.

 

(j)Ultragenyx has no Knowledge of any material adverse information with respectto thesafetyandefficacyofanyCompoundorProductthathasnotbeendisclosedtoTakeda,and all such information that has been disclosed is true, correct, and complete in all materialrespects.

 

(k)No claim or litigation in the Territory has been brought or, toUltragenyx’s Knowledge, threatened by any Person alleging, and Ultragenyx has no Knowledge of anyclaim, whetherornotasserted:(i)that anyoftheUltragenyxPatentsisinvalidorunenforceable,(ii) that the Regulatory Materials, the Ultragenyx Intellectual Property, or the disclosing,copying,

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making, assigning, or licensing of the Regulatory Materials or the UltragenyxIntellectual Property, violates, infringes, or otherwise conflicts or interferes with, or would violate,infringe, or otherwise conflict or interfere with, any intellectual property or proprietary right  ofany Person; or (iii) related to the Development or Commercialization of the Products, includingany claims of ProductLiability.

 

(l)InperformingitsobligationsunderthisAgreementUltragenyxshall,andshall cause its Affiliates to, comply with all Applicable Laws, including any applicableanti-corruption or anti-bribery laws or regulation, of any Governmental Authority with jurisdiction overthe activities performed by Ultragenyx or its Affiliates in furtherance of suchobligations.

 

(m)Ultragenyx, without the prior written consent of Takeda, during the Term, willnot solicit, induce, encourage, or participate in soliciting, inducing, or encouraging any employeeof Takeda,oranyofitsAffiliates,toterminatehisorherrelationshipwithTakedaorTakeda’s Affiliate. An offer of employment to an employee of Takeda by Ultragenyx  whichresults directly from unsolicited responses to general advertisements for employment will notbe deemed to be in violation of thisprovision.

 

(n)[***].

 

(o)Ultragenyx has provided Takeda with true and correct copies (as of theExecution Date)ofallUltragenyxIn-LicenseAgreementsineffectasoftheExecutionDate.Noneof Ultragenyx, its Affiliates and, to their Knowledge, any Third Party, is in breach ofany Ultragenyx In-License Agreement and none of Ultragenyx, its Affiliates and, totheir Knowledge, any other party to any Ultragenyx In-License Agreement has threatened to terminate, or has otherwise alleged any material breach under, such agreement andeach Ultragenyx In-License Agreement is in full force and effect in accordance with itsterms

 

13.4  No Other Representations or Warranties.   EXCEPT AS EXPRESSLY SET  FORTH IN THIS ARTICLE 13, THE PARTIES MAKE NO REPRESENTATIONS ORWARRANTIES OFANYKINDWHATSOEVER,EITHEREXPRESSORIMPLIED,WRITTENORORAL, EITHERINFACTORBYOPERATIONOFLAW,BYSTATUTEOROTHERWISE,AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES,INCLUDING ANY EXPRESS OR IMPLIED WARRANTY OF QUALITY,MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OFNON-INFRINGEMENT OR AS TO THE VALIDITY OF ANY PATENTS IN THETERRITORY.

 

ARTICLE 14  –CONFIDENTIALITY

 

14.1Nondisclosure.EachPartyagreesthat,duringtheTermandforaperiodoften(10) years thereafter, a Party (the “Receiving Party”) receiving Confidential Information of theother Party (the “Disclosing Party”) shall (a) maintain in confidence such ConfidentialInformation usingnotlessthantheeffortssuchReceivingPartyusestomaintaininconfidenceitsown confidential or proprietary Information of similar kind and value, (b) not disclosesuch

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ConfidentialInformationtoanyThirdPartywithoutthepriorwrittenconsentoftheDisclosing Party, except for disclosures expressly permitted below, and (c) not use suchConfidential Information for any purpose except those permitted by this Agreement (it being understoodthat this Section 14.1 shall not create or imply any rights or licenses not expressly granted underthis Agreement). Notwithstanding anything to the contrary in the foregoing, the obligations of confidentiality and non-use with respect to any trade secret within such ConfidentialInformation shallsurvivesuchten(10)yearperiodforsolongassuchConfidentialInformationremains protected as a trade secret under ApplicableLaws.

 

14.2Exceptions.  The obligations in Section 14.1 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competentevidence:

 

(a)is publicly disclosed by the Disclosing Party, either before or after it isdisclosed to the Receiving Partyhereunder;

 

(b)is known to the Receiving Party or any of its Affiliates, without any obligationto keep it confidential or any restriction on its use, prior to disclosure by the DisclosingParty;

 

(c)is subsequently disclosed to the Receiving Party or any of its Affiliates on anon- confidentialbasisbyaThirdPartythat,totheReceivingParty’sKnowledge,isnotboundbya similar duty of confidentiality or restriction on itsuse;

 

(d)isnow,orhereafterbecomes,throughnoactorfailuretoactonthepartofthe ReceivingPartyoranyofitsAffiliates,generallyknownoravailable,eitherbeforeorafteritis disclosed to the ReceivingParty;

 

(e)isindependentlydiscoveredordevelopedbyoronbehalfoftheReceivingParty or any of its Affiliates without the use of or access to Confidential Information belonging tothe Disclosing Party;or

 

(f)is the subject of written permission to disclose provided by the DisclosingParty.

 

14.3Authorized Disclosure. The Receiving Party may disclose ConfidentialInformation belongingtotheDisclosingPartyonlytotheextentsuchdisclosureisreasonablynecessaryin the following instances: filing or prosecuting Patents as permitted by thisAgreement;

 

(b)filing Regulatory Materials in order to obtain or maintain RegulatoryApprovals;

 

(c)prosecuting or defending litigation, including responding to a subpoena in aThird Partylitigation;

 

(d)complying with Applicable Laws or regulations or court or administrativeorders;

or

 

(e)to its Affiliates, sublicensees or prospective sublicensees, subcontractorsor prospectivesubcontractors,payors,consultants,agentsandadvisorsona“need-to-know”basis

 

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in order for the Receiving Party to exercise its rights or fulfill its obligations underthis Agreement,eachofwhompriortodisclosuremustbeboundbyobligationsofconfidentiality and restrictions on use of such Confidential Information that are no less restrictive than thoseset forth in this ARTICLE 14; provided, however, that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Section 14.3 to treat such Confidential Informationas required under this ARTICLE14.

 

(f)If and whenever any Confidential Information is disclosed in accordance withthis Section14.3,suchdisclosureshallnotcauseanysuchinformationtoceasetobeConfidential Informationexcepttotheextentthatsuchdisclosureresultsinapublicdisclosureofsuch information(otherthanbybreachofthisAgreement).Notwithstandingtheforegoing,inthe eventaPartyisrequiredtomakeadisclosureoftheotherParty’sConfidentialInformation pursuant to clauses (a) through (d) of this Section 14.3, it will, except where impracticable,give reasonableadvancenoticetotheotherPartyofsuchdisclosureandusenotlessthanthesame efforts to secure confidential treatment of such information as it would to protect itsown confidentialinformationfromdisclosureandshallbejointlyandseverallyliableforanybreach of this ARTICLE 14 by suchPerson.

 

14.4Terms of this Agreement. The Parties acknowledge that this Agreement and all ofthe respective terms of this Agreement shall be treated as Confidential Information of bothParties.

 

14.5Publicity.ThePartiesshallmakeajointpublicannouncementoftheexecutionofthis AgreementintheformattachedasExhibit14.5,whichshallbeissuedatatimetobemutually agreedbytheParties.EachPartyagreesnottoissueanyotherpressreleaseorotherpublic statement disclosing other information relating to this Agreement or thetransactions contemplated hereby that contains information not previously publicly disclosed inaccordance with this Section 14.5 without the prior written consent of the other Party, not to beunreasonably withheld, conditioned ordelayed.

 

14.6Securities Filings. Notwithstanding anything to the contrary in this ARTICLE 14, inthe event either Party proposes to file with the Securities and Exchange Commission or thesecurities regulators of any state or other jurisdiction a registration statement or any otherdisclosure documentthatdescribesorreferstothetermsandconditionsofthisAgreementoranyrelated agreements between the Parties, such Party shall notify the other Party of such intention andshall providetheotherPartywithacopyofrelevantportionsoftheproposedfilingatleastten(10) BusinessDayspriortosuchfiling(andanyrevisionstosuchportionsoftheproposedfilinga reasonabletimepriortothefilingthereof),includinganyexhibitstheretothatrefertotheother PartyorthetermsandconditionsofthisAgreementoranyrelatedagreementsbetweenthe Parties. The Party making such filing shall cooperate in good faith with the other Party toobtain confidentialtreatmentofthetermsandconditionsofthisAgreementoranyrelatedagreements between the Parties that the other Party requests to be kept confidential or otherwiseafforded confidential treatment, and shall only disclose Confidential Information that it isreasonably advised by outside counsel is legally required to be disclosed. No such notice and provision ofa copy shall be required if the description of or reference to this Agreement or a relatedagreement

 

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betweenthePartiescontainedintheproposedfilinghasbeenincludedinanypreviousfiling made by the either Party in accordance with this Section 14.6 or otherwise approved by theother Party.

 

14.7Relationship to Confidentiality Agreement. As of the Effective Date, thisAgreement supersedes the Confidentiality Agreement; provided however, that all “ConfidentialInformation” disclosed or received by the Parties thereunder shall be deemed ConfidentialInformation hereunder and shall be subject to the terms and conditions of thisAgreement.

 

14.8Equitable Relief. Given the nature of the Confidential Information and thecompetitive damage that could result to a Party upon unauthorized disclosure, use or transfer of its Confidential Information to any Third Party, the Parties agree that monetary damages may notbe a sufficient remedy for any breach of this ARTICLE 14. In addition to all  other  remedies,a Party shall be entitled to seek specific performance and injunctive and other equitable relief asa remedy for any breach or threatened breach of this ARTICLE14.

 

14.9Publications. All publications relating to the use of the Compound and/or a Productin the Licensed Field shall be prepared, presented and/or published in accordancewith pharmaceutical industry accepted guidelines including: (a) International Committee ofMedical Journal Editors (ICMJE) guidelines, (b) Uniform Requirements for Manuscripts Submittedto Biomedical Journals: Writing and Editing for Biomedical Publication, (c)Pharmaceutical Research and Manufacturers of America (PhRMA) guidelines, and (d) Principles on Conductof ClinicalTrials.EachPartywillhavetherighttopublishsummariesofresultsofallClinical Trials conducted by such Party with respect to the use of a Product in the Licensed Field afterthe Effective Date; provided, however, that the other Party will have the right to review and comment on all proposed publications prior to submission of such publication. Thepublishing Party shall provide the other Party at least sixty (60) days prior notice to review and commenton theClinicalTrialsresults,ornon-clinicalstudyresultstobepublishedforthepurposesof preparing any necessary Patentfilings.

 

14.10Clinical Trial Transparency. Both Parties agree to collaborate to maintaincompliance with all Applicable Laws related to clinical trial transparency, as well as anyindustry guidelines/codes of conduct, or other obligations that may apply to either the sponsor ofany clinical trial and/or the owner of any Regulatory Approval, all as relates to any ResearchProduct or Licensed Product. The Parties shall cooperate to maintain clinical  trial transparency consistent with each sponsor’s clinical trial registration, summary result, and datasharing transparency policies and will support disclosure of Information as needed based on the needsof the sponsors of the study or the Regulatory Approval holder with respect to  anyResearch Product or LicensedProduct.

 

ARTICLE 15  – TERM AND TERMINATION

 

15.1Term. This Agreement shall become effective as of the Effective Date  and shall continue in full force and effect, unless earlier terminated pursuant to this ARTICLE 15, untilthe laterofthe(a)expirationoftheCollaborationTerm,(b)theexpirationoftheTakedaOption Term,(c)theexpirationoftheLicensedProductRoyaltyTermwithrespecttoallLicensed

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ProductsintheTerritory,or(d)theexpirationoftheTakedaRoyaltyTermwithrespecttoall Products the Takeda Territory (the“Term”).

 

|   | 15.2 | Termination for MaterialBreach. |   |
|--------|------|---------------------------------|--------|

 

(a)Either Party (the “Non-breaching Party”) may terminate this Agreement inits entirety (except as otherwise provided in this Section 15.2(a)) if the other Party (the“BreachingParty”)hasmateriallybreachedthisAgreement,andsuchmaterialbreachhasnotbeencured within sixty (60) days after receipt of written notice of such breach by the Breaching Partyfrom the Non-Breaching Party (the “Cure Period”); provided, however, that, notwithstandingthe foregoing,terminationpursuanttothisSection15.2(a)shallbeonaCompound-by-Compound andProduct-by-Productbasisunlesssuchmaterialbreachmateriallydiminishes,ormaterially frustrates,thevalueofthisAgreementtotheNon-breachingParty,takenasawhole,inwhich case the Non-breaching Party may terminate this Agreement in its entirety. Any terminationof this Agreement with respect to a Compound or Product, or in its entirety, pursuant to thisSection 15.2(a)shallbecomeeffectiveattheendoftheCurePeriod,unlesstheBreachingPartyhas curedanysuchmaterialbreachpriortotheexpirationofsuchCurePeriod.Therightofeither PartytoterminatethisAgreementwithrespecttoaCompoundorProduct,orinitsentirety,as providedinthisSection15.2(a)shallnotbeaffectedinanywaybysuchParty’swaiverofor failure to take action with respect to any previous breach under thisAgreement.

 

(b)If the Parties reasonably and in good faith disagree as to whether there has beena materialbreach,includingwhethersuchbreachwasmaterial,thePartythatdisputeswhether therehasbeenamaterialbreachmaycontesttheallegationinaccordancewithARTICLE16. NotwithstandinganythingtothecontrarycontainedinSection15.2(a),theCurePeriodforany DisputewillrunfromthedatethatwrittennoticewasfirstprovidedtotheBreachingPartyby the Non-Breaching Party through the resolution of such Dispute pursuant to ARTICLE 16, andit is understood and acknowledged that, during the pendency of a Dispute pursuant to thisSection 15.2(b),allofthetermsandconditionsofthisAgreementshallremainineffect,andtheParties shall continue to perform all of their respective obligations under thisAgreement.

 

(c)Notwithstanding the foregoing, following the execution of an OptionProduct License Agreement or Exercised Product License Agreement, the terms of suchlicense agreement shall govern the handling of termination for material breach with respect tothe activities that are the subject of such license agreement (which shall be on the basis ofthis Section 15.2) and any termination of this Agreement shall not affect the existence of suchOption Product License Agreement or Exercised Product LicenseAgreement.

 

|   | 15.3 | Termination for SafetyReasons. |   |
|--------|------|--------------------------------|--------|

 

(a)EachPartyshallhavetherighttoterminatethisAgreementonaCompound-by- CompoundandProduct-by-ProductbasiswithrespecttosuchParty’sfieldandterritoryatany time upon providing ninety (90) days prior written notice to the other Party (i) ifsenior executives responsible for the terminating Party’s pharmacovigilance and clinicalscience functions determine in good faith that the risk/benefit profile of the Compound or Product issuch thattheCompoundorProductcannotcontinuetobeDevelopedoradministeredtopatients

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safely;or(b)upontheoccurrenceofseriousadverseeventsrelatedtotheuseoftheCompound or Product that cause the terminating Party to conclude that the continued use of theCompound orProductbypatientswillresultinpatientsbeingexposedtoaproductinwhichtherisks outweigh thebenefits.

 

(b)Notwithstanding the foregoing, following the execution of an OptionProduct License Agreement or Exercised Product License Agreement, the terms of suchlicense agreement shall govern the handling of termination for safety reasons with respect tothe activities that are the subject of such license agreement (which shall be on the basis ofthis Section 15.3) and any termination of this Agreement shall not affect the existence of suchOption Product License Agreement or Exercised Product LicenseAgreement.

 

|   | 15.4 | Termination forConvenience. |
|--------|------|-----------------------------|

 

(a)Takeda shall have the right to terminate this Agreement with respect to the Takeda Option for any or no reason upon ninety (90) days writtennotice.

 

(b)ProvidedthatUltragenyxhascompletedDevelopmentactivitiesforaLicensed [***]ProductintheTakedaFieldassetforthintheInitial[***]DevelopmentPlanpursuantto Section 4.3(a), after the end of the Collaboration Term Ultragenyx shall have the rightto terminate this Agreement with respect to any or all Licensed Products in any or all countriesfor which it has rights with respect to such Licensed Products for any or no reason upon ninety(90) days writtennotice.

 

(c)Notwithstanding the foregoing, following the execution of an OptionProduct License Agreement or Exercised Product License Agreement, the terms of suchlicense agreement shall govern the handling of termination for convenience with respect to theactivities thatarethesubjectofsuchlicenseagreement(whichshallbeonthebasisofthisSection15.4) andanyterminationofthisAgreementshallnotaffecttheexistenceofsuchOptionProduct License Agreement or Exercised Product LicenseAgreement.

 

|   | 15.5 | Termination for Patent Challenge. |
|--------|------|-----------------------------------|

 

(a)TakedamayterminatethisAgreementwithrespecttotheLicensedProductsat anytimeuponprovidingwrittennoticetoUltragenyx,ifUltragenyx,oranyofUltragenyx’s Affiliates,directly,orindirectlythroughassistancegrantedtoaThirdParty,commencesany interference or opposition proceeding, challenges the validity or enforceability of, or opposesany extension of or the grant of a supplementary protection certificate with respect to anyTakeda Patent or any other Patent owned or controlled by Takeda that claims or disclosesthe composition of matter or the method of making or using a LicensedProduct.

 

(b)Takeda may terminate this Agreement with respect to all CandidateProducts and/orOptionProductsatanytimeuponprovidingwrittennoticetoUltragenyx,ifUltragenyx, oranyofUltragenyx’sAffiliates,directly,orindirectlythroughassistancegrantedtoaThird Party, commences any interference or opposition proceeding, challenges the validityor enforceability of, or opposes any extension of or the grant of a supplementaryprotection

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certificatewithrespecttoanyTakedaPatentoranyotherPatentControlledbyTakedathat claimsordisclosesthecompositionofmatterorthemethodofmakingorusingaCandidate Product and/or OptionProduct.

 

(c)Ultragenyx may terminate this Agreement with respect to an UltragenyxPipeline ProductatanytimeuponprovidingwrittennoticetoTakeda,ifTakeda,oranyofTakeda’s Affiliates,directly,orindirectlythroughassistancegrantedtoaThirdParty,commencesany interference or opposition proceeding, challenges the validity or enforceability of, or opposesany extension of or the grant of a supplementary protection certificate with respect to anyUltragenyx Patent or any other Patent Controlled by Ultragenyx that claims or discloses the compositionof matter or the method of making or using such Ultragenyx PipelineProduct.

 

(d)Notwithstanding the foregoing, following the execution of an OptionProduct License Agreement or Exercised Product License Agreement, the terms of suchlicense agreement shall govern the handling of termination for patent challenge with respect tothe activitiesthatarethesubjectofsuchlicenseagreement(whichshallbeonthebasisofthis Section 15.5) and any termination of this Agreement shall not affect the existence of suchOption Product License Agreement or Exercised Product LicenseAgreement.

 

|   | 15.6 | Termination for Insolvency. |
|--------|------|-----------------------------|

 

(a)Either Party may terminate this Agreement in its entirety upon providingwritten notice to the other Party on or after the time that such other Party makes a general assignmentfor the benefit of creditors, files an insolvency petition in bankruptcy, petitions for or acquiescesin the appointment of any receiver, trustee or similar officer to liquidate or conserve its businessor anysubstantialpartofitsassets,commencesunderthelawsofanyjurisdictionanyproceeding involving its insolvency, bankruptcy, reorganization, adjustment of debt, dissolution,liquidation oranyothersimilarproceedingforthereleaseoffinanciallydistresseddebtors,orbecomesa party to any proceeding or action of the type described above, and such proceeding oraction remains un-dismissed or un-stayed for a period of more than ninety (90)days.

 

(b)All rights and licenses granted under or pursuant to this Agreement are, andshall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United StatesCode and other similar laws in any other jurisdiction outside of the Territory (collectively,the “Bankruptcy Laws”), licenses of rights to “intellectual property” as defined  underthe Bankruptcy Laws. If a case is commenced during the Term by or against a Partyunder Bankruptcy Laws then, unless and until this Agreement is rejected as provided pursuant tosuch Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and itssuccessors andassigns(includingaTitle11trustee)shallperformalloftheobligationsinthisAgreement intended to be performed by such Party. If a case is commenced during the Term by or againsta Party under the Bankruptcy Laws, this Agreement is rejected as provided for underthe Bankruptcy Laws, and the non-bankrupt Party elects to retain its rights hereunder as providedfor undertheBankruptcyLaws,thenthePartysubjecttosuchcaseundertheBankruptcyLaws(in any capacity, including debtor-in-possession) and its successors and assigns (including a Title11 trustee), shall provide to the non-bankrupt Party copies of all Patents and Informationnecessary forthenon-bankruptPartytoprosecute,maintainandenjoyitsrightsunderthetermsofthis

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Agreement. All rights, powers and remedies of the non-bankrupt Party as provided herein arein additiontoandnotinsubstitutionforanyandallotherrights,powersandremediesnowor hereafter existing at law or in equity (including the Bankruptcy Laws) in the event ofthe commencement of a case by or against a Party under the Bankruptcy Laws. In particular, it isthe intention and understanding of the Parties to this Agreement that the rights granted to theParties under this Section 15.6 are essential to the Parties’ respective businesses and theParties acknowledge that damages are not an adequateremedy.

 

(c)Notwithstanding the foregoing, following the execution of an OptionProduct License Agreement or Exercised Product License Agreement, the terms of suchlicense agreementshallgovernthehandlingofterminationforinsolvencywithrespecttotheactivities thatarethesubjectofsuchlicenseagreement(whichshallbeonthebasisofthisSection15.6) andanyterminationofthisAgreementshallnotaffecttheexistenceofsuchOptionProduct License Agreement or Exercised Product LicenseAgreement.

 

|   | 15.7 | Effects of Termination. |
|--------|------|-------------------------|

 

(a)Effects of Termination of Agreement in itsEntirety

 

(i)In the event of a termination of this Agreement in its entiretyby Ultragenyx pursuant to Section 15.2 (Breach) and 15.6 (Insolvency), Ultragenyx may electeither ofthefollowingoptions(A)or(B)byprovidingwrittennoticeofitselectionwithitsnoticeof termination:

 

(A)to effectuate actual termination of this Agreement in itsentirety, in which case the following shallapply:

 

(I)all rights and licenses granted toUltragenyx hereunder shall terminate immediately;

 

(II)all rights and licenses granted byUltragenyx hereundershallterminateimmediatelyotherthantheTakeda[***]License,whichlicenseshall becomenon-exclusiveunderanyintellectualpropertynotassignedtoTakedapursuanttothe remainder of this Section 15.7(a)(i)(A), and which license shall apply to the Licensed[***] Compound, Licensed Analog Compounds, Licensed Products and ResearchProducts;

 

(III)Ultragenyx, as soon as reasonably practical afterthe effectivedateofsuchtermination,shallprovidetoTakeda,asapplicableandtotheextent permitted under any applicable Third Party contract, (1) any Information, including copies ofall Clinical Trial data and results, and the like developed by or for the benefit of Ultragenyxrelating to a Licensed Product or Research Product, and (2) other documents to the extent relating tothe Licensed [***] Compounds, Licensed Analog Compounds, [***] Compounds, CandidateProducts, Licensed Products or Research Products that are necessary for their Exploitation. Ultragenyx will cooperate with Takeda to provide a transfer of such Information and documents atTakeda’s expense.AtTakeda’srequest,UltragenyxshallassigntoTakedaanyandallagreementsto which Ultragenyx, or its Affiliate, and a Third Party are parties, and that govern theExploitation

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activitiesconductedinconnectionwithsuchCompoundsorProductspriortosuchtermination, or,ifsuchassignmentisnotpermittedundertherelevantagreement:(i)granttoTakedaother rightstoprovidetoTakedathebenefitofsuchnon-assignableagreement,atTakeda’sexpense, to the extent permitted under the terms of such non-assignable agreement; or (ii) to the extentnot permittedunderthetermsofsuchnon-assignableagreement,thePartiesshalldiscussingood faithanalternativesolutiontoenableTakedatoreceive,atTakeda’sexpense,thebenefitofthe termsofsuchnon-assignableagreement.InadditiontotheactionscontemplatedinthisSection 15.7(a)(i)(A)(III),Ultragenyxshalltakesuchotheractionsandexecutesuchotherinstruments, assignmentsanddocuments,atTakeda’sexpense,asmaybenecessarytoeffectthetransferof rights to such Compound(s) and Product(s) hereunder toTakeda;

 

(IV)Ultragenyx shall, at Takeda’s expense, transferto Takeda any and all Regulatory Documentation related to a Licensed Product orResearch Product,includinganyProductINDsandProductRegulatoryApprovalsand,uponTakeda’s request, shall make available to Takeda any other relevant information reasonably related tosuch Regulatory Documentation;and

 

(V)effective on the date of termination, Ultragenyx,for itselfandonbehalfofitsAffiliates,herebyassigns(andtotheextentsuchassignmentcanonly be made in the future hereby agrees to assign) to Takeda all right, title and interest in and toany Licensed Product Improvements, Licensed Product Improvement Patents, OptionProduct Improvements, and Option Product Improvement Patents, in each case where Controlledby Ultragenyx or its Affiliates. Ultragenyx will, at Takeda’s expense, execute andrecord assignments and other necessary documents consistent with such change in ownership;or

 

(B)in lieu of actual termination under (A) above, Ultragenyxmay elect that all rights and licenses granted to Ultragenyx hereunder shall continue underthis AgreementandanymilestoneorroyaltypaymentsthatbecomeduetoTakedabyUltragenyx withrespecttoLicensedProductaftersuchterminationshall be[***] and paid to Takeda in accordance with the payment provisions of this Agreement. ThisSection 15.7(a)(i)(B) may only be exercisedonce.

 

(ii)IntheeventofaterminationofthisAgreementinitsentiretybyTakeda pursuant to Section 15.2 (Breach) or 15.6 (Insolvency), Takeda may elect either of thefollowing options (A) or (B) by providing written notice of its election with its notice oftermination:

 

(A)to effectuate actual termination of this Agreement in itsentirety, in which case the following shallapply:

 

(I)all rights and licenses granted to Takedahereunder shallterminateimmediately,otherthantheTakeda[***]License,whichlicenseshallbecome non-exclusiveunderanyintellectualpropertynotassignedtoTakedapursuanttotheremainder ofthisSection15.7(a)(ii)(A),andwhichlicensesshallapplytotheLicensed[***]Compound, Licensed Analog Compounds, Licensed Products and ResearchProducts;

 

|   | (II) | allrightsandlicensesgrantedbyTakedahereunder |
|--------|------|----------------------------------------------|

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shall terminateimmediately;

 

(III)if not already completed and provided,Ultragenyx shallcompleteandprovideareportoftheDevelopmentactivitiesfortheLicensed[***]Product intheTakedaFieldassetforthintheInitial[***]DevelopmentPlaninaccordancewithSection 4.3(a);

 

(IV)Ultragenyx, as soon as reasonably practical afterthe effectivedateofsuchtermination,shallprovidetoTakeda,asapplicableandtotheextent permitted under any applicable Third Party contract, (1) any Information, including copies ofall Clinical Trial data and results, and the like developed by or for the benefit of Ultragenyxrelating to a Licensed Product or Research Product, and (2) other documents to the extent relating tothe Licensed [***] Compounds, Licensed Analog Compounds, [***] Compounds, CandidateProducts, Licensed Products or Research Products that are necessary for their Exploitation. Ultragenyx will cooperate with Takeda to provide a transfer of such material Information and documentsat Ultragenyx’s expense. At Takeda’s request, Ultragenyx shall assign to Takeda any  andall PatentsandagreementstowhichUltragenyx,oritsAffiliate,andaThirdPartyareparties,and that govern the Exploitation activities conducted in connection with such Compounds or Productspriortosuchtermination,or,ifsuchassignmentisnotpermittedundertherelevant agreement: (i) grant to Takeda other rights to provide to Takeda the benefit of suchnon- assignableagreement,atUltragenyx’sexpense,totheextentpermittedunderthetermsofsuch non-assignable agreement; or (ii) to the extent not permitted under the terms of suchnon- assignableagreement,thePartiesshalldiscussingoodfaithanalternativesolutiontoenable Takedatoreceive,atUltragenyx’sexpense,thebenefitofthetermsofsuchnon-assignable agreement. In addition to the actions contemplated in this Section 15.7(a)(ii)(A)(IV),Ultragenyx shall take such other actions and execute such other instruments, assignments and documents,at Ultragenyx’sexpense,asmaybenecessarytoeffectthetransferofrightstosuchCompound(s) and Product(s) hereunder to Takeda;

 

(V)Ultragenyx shall, at its expense, transfer  toTakeda any and all Regulatory Documentation related to a Licensed Product or ResearchProduct, including any Product INDs and Product Regulatory Approvals and, upon  Takeda’srequest, shall make available to Takeda any other relevant information reasonably related tosuch Regulatory Documentation;and

 

(VI)effective on the date of termination, Ultragenyx,for itselfandonbehalfofitsAffiliates,herebyassigns(andtotheextentsuchassignmentcanonly be made in the future hereby agrees to assign) to Takeda all right, title and interest in and toany Licensed Product Improvements, Licensed Product Improvement Patents, OptionProduct Improvements, and Option Product Improvement Patents, in each case where Controlledby Ultragenyx or its Affiliates. Ultragenyx will, at its expense, execute and record assignmentsand other necessary documents consistent with such change in ownership;or

 

(B)in lieu of actual termination under (A) above, Takeda mayelect that all rights and licenses granted to Takeda hereunder shall continue under this Agreementand anymilestonesorroyaltypaymentsthatbecomeduetoUltragenyxbyTakedawithrespectto

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any Exercised Product after such termination shall be reduced by fifty percent (50%) and paidto Ultragenyx in accordance with the payment provisions of this Agreement. ThisSection 15.7(a)(ii)(B) may only be exercisedonce.

 

(iii)For clarity, an Exercised Product License Agreement or an OptionProduct License Agreement shall include termination provisions similar to this Section 15.7(a) andshall otherwise govern the effects of termination of such agreement in itsentirety.

 

(b)Effects of Termination of a Compound or Product for Safety Reasons. Inthe eventofaterminationofthisAgreementwithrespecttoaparticularCompoundorProduct pursuant to Section 15.3 (for the avoidance of doubt, not a Terminated Product)then:

 

(i)alllicenserightsreceivedbytheterminatingPartyandallobligationsof the terminating Party with respect to the terminated Compound or Product shall cease and,with respect to the terminating Party only, this Agreement shall automatically be deemed tobe amendedtoexcludesuchrightsandobligationsoftheterminatingPartywithrespecttothe terminatedCompoundorProductbutshallotherwisesurviveandcontinueineffectforthe remaining Compounds and Products;and

 

(ii)the non-terminating Party shall continue to have all rights andobligations under this Agreement with respect to the terminated Compound or Product (includingthe obligation to make royalty, milestone and other payments to the terminating Party) unless italso elects to terminate the particular Compound or Product pursuant to Section15.3.

 

(c)Effects of Termination with Respect to a Terminated Product. In the eventof terminationofthisAgreementwithrespecttoaTerminatedProduct(butnotinthecaseofany termination of this Agreement in its entirety)then:

 

(i)all rights and licenses granted hereunder by either Party shall automaticallybedeemedtobeamendedtoexcludetheTerminatedProductbutshallotherwise survive and continue in effect for the remaining Compounds andProducts;

 

(ii)in the case of termination for convenience pursuant to Section 15.4, ifan Option Negotiation Period or Takeda Option Negotiation Period is then ongoing, the Termwith respecttosuchOptionProductorExercisedProduct,asapplicable,willautomaticallyextend until the earlier of (A) expiration of such Option Negotiation Period or TakedaOption NegotiationPeriod,asapplicable,or(B)executionoftheapplicableOptionProductLicense Agreement or Exercised Product LicenseAgreement;

 

(iii)if the Terminated Product is a Licensed Product, if not alreadycompleted andprovided,UltragenyxshallcompleteandprovideareportoftheDevelopmentactivitiesfor the Licensed [***] Product in the Takeda Field as set forth in the Initial [***] Development Planin accordance with Section4.3(a);

 

(iv)Ultragenyx, as soon as reasonably practical after the effective date ofsuch termination, shall provide to Takeda, as applicable and to the extent permitted underany

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applicableThirdPartycontract,(A)anyInformation,includingcopiesofallClinicalTrialdata andresults,andthelikedevelopedbyorforthebenefitofUltragenyxrelatingtoaTerminated Product,and(B)otherdocumentstotheextentrelatingtotheTerminatedProductsthatare necessary for their Exploitation. Ultragenyx will cooperate with Takeda to provide a transferof such material Information and documents. Ultragenyx shall assign to Takeda any and allPatents andagreementstowhichUltragenyx,oritsAffiliate,andaThirdPartyareparties,andthat govern the Exploitation activities conducted in connection with a Terminated Product priorto such termination, or, if such assignment is not permitted under the relevant agreement: (1)grant to Takeda other rights to provide to Takeda the benefit of such non-assignable agreement tothe extentpermittedunderthetermsofsuchnon-assignableagreement;or(2)totheextentnot permittedunderthetermsofsuchnon-assignableagreement,thePartiesshalldiscussingood faith an alternative solution to enable Takeda to receive the benefit of the terms of suchnon- assignable agreement. In addition to the actions contemplated in this Section 15.7(c)(iv), Ultragenyx shall take such other actions and execute such other instruments, assignmentsand documentsasmaybenecessarytoeffectthetransferofrightstosuchTerminatedProducts hereunder to Takeda.  Each Party shall bear its own expenses under this Section15.7(c)(iv);

 

(v)Ultragenyx shall transfer to Takeda any and all RegulatoryDocumentation directlyandsolelyrelatedtoaTerminatedProduct,includinganyProductINDsandProduct RegulatoryApprovalsand,uponTakeda’srequest,shallmakeavailabletoTakedaanyother relevant information reasonably related to such RegulatoryDocumentation;

 

(vi)effective on the date of termination, Ultragenyx, for itself and on behalfof itsAffiliates,herebyassigns(andtotheextentsuchassignmentcanonlybemadeinthefuture herebyagreestoassign)toTakedaallright,titleandinterestinandtoanyLicensedProduct Improvements, Licensed Product Improvement Patents, Option Product Improvements,and OptionProductImprovementPatentstotheextenttheforegoingCoveraTerminatedProduct and are Controlled by Ultragenyx or its Affiliates. Ultragenyx will execute andrecord assignments and other necessary documents consistent with such change in ownership;and

 

(vii)Takedashallhavetherighttoassumeallprosecution,maintenance,and enforcementactivitieswithrespecttoPatentsunderthisAgreementCoveringtheTerminated Products. Ultragenyx will cooperate with Takeda and provide Takeda with reasonableassistance andcooperationwiththeprosecution,maintenance,andenforcementactivitieswithrespectto suchPatents.

 

(d)Effect of Termination on Ultragenyx’s Put Rights under the CommonStock Purchase Agreement. Immediately upon (i) written notice of termination of this Agreementin itsentiretypursuanttoSection15.2,or15.6,(ii)writtennoticeofterminationofaLicensed ProductorResearchProductpursuanttoSection15.2,15.3,15.4,15.5,18.5or(iii)uponthe Ultragenyx[***]LicenseterminatingpursuanttoSection4.3(f),Ultragenyx’srightsunderthe CommonStockPurchaseAgreementtorequirethepurchaseoftheSecondTrancheSharesand ThirdTrancheShares(assuchtermsaredefinedintheCommonStockPurchaseAgreement) shall be suspended and such rights shall automatically terminate on the effective date ofsuch termination, provided, however, there shall be no suspension or termination of suchUltragenyx

 

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rightsundertheCommonStockPurchaseAgreementtotheextentUltragenyxterminatesthe Agreement,aLicensedProductorResearchProductpursuanttoSection15.2.Wherewritten noticeofterminationpursuanttoSection15.2isprovidedbyTakeda,andUltragenyxcuresall material breaches during the Cure Period, the suspension shall be removed on the effectivedate of suchcure.

 

|   | 15.8 | Effect ofExpiration |
|--------|------|---------------------|

 

(a)Expiration of Collaboration Term. Upon expiration of the CollaborationTerm for a given ResearchProduct:

 

(i)All rights to such Research Product shall revert to Takeda except forthose rights, if any, granted to Ultragenyx under an Option Product LicenseAgreement;

 

(ii)As soon as reasonably practical after the effective date of expiration ofthe CollaborationTermforagivenResearchProduct,Ultragenyxshall,exceptwhereotherwise providedunderanOptionProductLicenseAgreement,providetoTakeda,asapplicableandto theextentpermittedunderanyapplicableThirdPartycontract(1)anyInformation,including copiesofallClinicalTrialdataandresults,andthelikedevelopedbyorforthebenefitof UltragenyxrelatingtosuchResearchProductand(2)otherdocumentstotheextentrelatingto such Research Product that are necessary for their continued Exploitation. Ultragenyxwill cooperate with Takeda to provide a transfer of such material Information and documents.At Takeda’s request, Ultragenyx shall assign to Takeda any and all Patents and agreements towhich Ultragenyx,oritsAffiliate,andaThirdPartyareparties,andthatgoverntheExploitation activities conducted in connection with such Research Product prior to such expiration, or ifsuch assignment is not permitted under the relevant agreement: (i) grant to Takeda other rightsto provide to Takeda the benefit of such non-assignable agreement to the extent permitted underthe termsofsuchnon-assignableagreement;or(ii)totheextentnotpermittedunderthetermsof suchnon-assignableagreement,thePartiesshalldiscussingoodfaithanalternativesolutionto enable Takeda to receive the benefit of the terms of such non-assignable agreement. In addition totheactionscontemplatedinthisSection15.8(a)(ii),Ultragenyxshalltakesuchotheractions andexecutesuchotherinstruments,assignmentsanddocumentsasmaybenecessarytoeffect thetransferofrightstosuchProducttoTakeda.EachPartyshallbearitsownexpensesunder this Section15.8(a)(ii);

 

(iii)Ultragenyx shall transfer to Takeda any and all RegulatoryDocumentation directlyandsolelyrelatedtosuchResearchProduct,includinganyProductINDsandProduct RegulatoryApprovalsand,uponTakeda’srequest,shallmakeavailabletoTakedaanyother relevant information reasonably related to such Regulatory Documentation;and

 

(iv)Takedashallhavetherighttoassumeallprosecution,maintenance,and enforcementactivitieswithrespecttoPatentsunderthisAgreementCoveringsuchResearch Product. Ultragenyx will cooperate with Takeda and provide Takeda with reasonableassistance andcooperationwiththeprosecution,maintenance,andenforcementactivitieswithrespectto suchPatents.

 

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(b)Expiration of Licensed Product Royalty Term. Upon the expiration ofthe LicensedProductRoyaltyTermforeachLicensedProductineachcountryintheTerritory, Ultragenyx shall have a non-exclusive, fully-paid up and irrevocable license under theLicensed [***]TechnologywithrespecttosuchLicensedProductinsuchcountryintheUltragenyxField for LicensedProducts.

 

(c)Expiration of Exercised Product License Agreement and OptionProduct License Agreement. Each Exercised Product License Agreement and Option ProductLicense Agreement shall provide that, upon expiration of the applicable royalty term, Takeda shall havea non-exclusive,fully-paidupandirrevocablelicensewithrespecttotheExercisedProductsand Licensed Option Products,respectively.

 

15.9Remedies. Notwithstanding anything to the contrary in this Agreement, exceptas otherwisesetforthinthisAgreement,terminationorexpirationofthisAgreementshallnot relievethePartiesofanyliabilityorobligationwhichaccruedhereunderpriortotheeffective date of such termination or expiration, nor prejudice either Party’s right to obtain performanceof any obligation. Each Party shall be free, pursuant to ARTICLE 16, to seek, without restrictionas tothenumberoftimesitmayseek,damages,costsandremediesthatmaybeavailabletoit under Applicable Laws or in equity and shall be entitled to offset the amount of any damagesand costsobtainedagainsttheotherPartyinafinaldeterminationunderSection16.4,againstany amounts otherwise due to such other Party under thisAgreement.

 

15.10Survival.Thefollowingprovisionsshallsurviveanyexpirationorterminationofthis Agreementfortheperiodoftimespecifiedtherein(or,ifnosuchperiodisspecified, indefinitely): ARTICLE 1 (Definitions); ARTICLE 16 (Dispute Resolution); and ARTICLE 17 (Indemnification); and Sections 4.5 (Records; Disclosure of Data and Results), 6.6(b) (Research Materials Transfer), 11.9, 11.10, 11.11, 11.12, 11.13 (Payment, Taxes, Audit); 12.1(Ownership ofInventions);14.1,14.2,14.3,14.4,14.5,14.6,14.7,14.8(Confidentiality);15.7,15.8,15.9, 15.10 (Termination); 18.3, 18.7, 18.8, 18.9, 18.10, 18.14, 18.15, 18.16, and18.17 (Miscellaneous).

 

ARTICLE 16  – DISPUTERESOLUTION

 

16.1ExclusiveDisputeResolutionMechanism.ExceptfordisputesforwhichaPartyhas finaldecisionmakingauthorityunderthisAgreement,includingSections2.1(b)(ii),2.2(c)(ii) and 12.4, the Parties agree that the procedures set forth in this ARTICLE 16 shall  bethe exclusivemechanismforresolvinganydispute,controversy,orclaimbetweenthePartiesthat may arise from time to time pursuant to this Agreement relating to either Party’s rightsor obligationshereunder(each,a“Dispute”,andcollectively,the“Disputes”)thatisnotresolved through good faith negotiation between theParties.

 

16.2Resolution by Executive Officers. In the event of any Dispute, the Parties shallfirst attempt in good faith to resolve such Dispute by negotiation and consultationbetween themselves.IntheeventthatsuchDisputeisnotresolvedonaninformalbasiswithinten(10) BusinessDaysafterreceiptofwritingnoticeofsuchDisputebyaParty,eitherPartymay,by writtennoticetotheotherParty,refertheDisputetotheSeniorOfficersoftheotherPartyfor

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attempted resolution by good faith negotiation within thirty (30) days after such noticeis received. Except where exclusive decision-making authority rests with a Party underthis Agreement (including Sections 2.1(b)(ii), 2.2(c)(ii) and 12.4), each Party may, in itssole discretion,seekresolutionofanyandallDisputesthatarenotresolvedunderthisSection16.2 using (a) arbitration pursuant Section 16.3 where arbitration pursuant to Section 16.3is specifically provided for in this Agreement or (b) otherwise, pursuant to Section16.4.

 

16.3Baseball Arbitration. Any Dispute for which arbitration pursuant to this Section 16.3is specificallyprovidedforinthisAgreementshallbefinallydecidedbyexpeditedarbitrationin accordance with the following abbreviated dispute resolutionprocedures:

 

(a)IftheDisputeisnotresolvedwithinthirty(30)daysafterreferraltotheParty’s respectiveSeniorOfficerspursuanttoSection16.2,eitherPartymaysendtheotherPartya writtennoticethatitwishestoresolvetheDisputebyusinganeutralThirdPartywhoisan Expert with at least fifteen (15) years of experience in area of the Dispute (the “NeutralExpert”). The date of the other Party’s receipt of such written notices shall be the “NoticeDate.”

 

(b)Within fifteen (15) Business Days of the Notice Date, each Party shall notifythe other Party in writing of its appointed Expert (each, a “Representative Expert”).The Representative Experts for each Party shall jointly appoint the Neutral Expert within fifteen(15) BusinessDays.

 

(c)Within ten (10) Business Days after the appointment of the Neutral Expert,each PartyshallsubmittotheotherPartyandtheNeutralExpertawrittensummaryregardingits position with respect to the Dispute. Contemporaneously with the submission of itswritten summaryregardingitsposition,eachPartyshallprovidetheotherPartyandtheNeutralExpert with copies of all documents it relied upon in its written summary; provided that each Partymay redact any portion of such documents which are covered by an applicable privilege or donot relatetothesubjectmatterofthisAgreement.Withinthree(3)BusinessDaysofreceiptofthe other Party's written summary regarding its position, each Party may submit anopposition statement of no more than five (5) pages in length (excluding exhibits and declarations).Neither Partywillbeallowedtoconductanydiscovery.NeitherPartymayhaveanycommunications (either written or oral) with the other Party’s Representative Experts or the Neutral Expertother thanforthesolepurposeofengagingtheexpertpanelorasexpresslypermittedinthisSection 16.3; provided, that oral presentations and follow-up written submissions may be made tothe Neutral Expert at such Neutral Expert's request. The Neutral Expert may consult in writingwith theRepresentativeExpertsregardingthesubmissionsmadebyeitherParty;providedthatboth RepresentativeExpertsareawareofsuchconsultationandprovidedanopportunitytorespond. EvaluatingeachParty’swrittensubmissions,theNeutralExpertshall,withinten(10)Business Days of receipt of the written opposition statement, select in total, either Takeda's submissionor Ultragenyx’s submission. Such decision shall be final, binding and notappealable.

 

(d)ThePartywhosesubmissionisnotselectedshallbesolelyresponsibleforthe expensesandfeesoftheNeutralExpertandthereasonablecostsandfeesoftheotherParty’s RepresentativeExpert.

 

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16.4Litigation.AnyunresolvedDisputethatwassubjecttoSection16.2,shallbebrought exclusivelyinacourtofcompetentjurisdiction,federalorstate,locatedinNewYork,New York, and in no other jurisdiction. Each Party hereby consents to personal jurisdiction andvenue in, and agrees to service of process issued or authorized by, suchcourt.

 

16.5Preliminary Injunctions. Notwithstanding anything in this Agreement to the contrary,a Party may seek a temporary restraining order or a preliminary injunction from any courtof competent jurisdiction in order to prevent immediate and irreparable injury, loss, or damage ona provisional basis, pending the decision of the arbitrator(s) on the ultimate merits of anyDispute.

 

16.6Patent and Trademark Disputes. Notwithstanding anything in this Agreement tothe contrary, any and all issues regarding the scope, construction, validity, and enforceability ofany Patent or trademark relating to a Product that is the subject of this Agreement shall be determinedinacourtorothertribunal,asthecasemaybe,ofcompetentjurisdictionunderthe applicable patent or trademark laws of the country in which such Patent or trademark rightswere granted orarose.

 

16.7Confidentiality. Any and all activities conducted under ARTICLE 16, including anyand allproceedingsanddecisionsunderSection16.4,shallbedeemedConfidentialInformationof each of the Parties, and shall be subject to ARTICLE14.

 

16.8WAIVER OF RIGHT TO JURY TRIAL. In connection with the Parties’ rightsunder Section16.4,EACHPARTY,TOTHEEXTENTPERMITTEDBYAPPLICABLELAWS, KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TOA TRIAL BY JURY IN ANY ACTION OR OTHER LEGAL PROCEEDING ARISING OUTOF OR RELATING TO THIS AGREEMENT AND THE TRANSACTIONSIT CONTEMPLATES. THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER SOUNDING IN CONTRACT, TORT, OROTHERWISE.

 

ARTICLE 17  –INDEMNIFICATION

 

17.1Indemnification by Ultragenyx. Ultragenyx hereby agrees to defend, indemnifyand hold harmless Takeda and its Affiliates, and each of their respective directors,officers, employees, agents and representatives (each, a “Takeda Indemnitee”) from and against anyand all claims, suits, actions, demands, liabilities, expenses and/or loss, including reasonablelegal expenseandattorneys’fees(collectively,the“Losses”),towhichanyTakedaIndemniteemay become subject as a result of any claim, demand, action or other proceeding by any ThirdParty (each,a“Claim”)totheextentsuchLossesarisedirectlyorindirectlyoutof:(i)thepracticeby Ultragenyx or its Affiliate of any license granted to it under ARTICLE 3; (ii) the Exploitationof a Compound or a Product by Ultragenyx, its Affiliates or its sublicensees on or after the Effective Date, including, for the avoidance of doubt, any Product Liabilities arising from theuse ofaProductintheLicensedFieldintheTerritoryonoraftertheEffectiveDateandanyLosses that may arise due to Ultragenyx, its Affiliates or its sublicensees continuing to Exploita Compound or Product in its territory or field that is the subject matter of a termination byTakeda pursuant to Section 15.3; (iii) the Exploitation of any Ultragenyx Pipeline  Productby Ultragenyx, its Affiliates or its licensees before the Effective Date, including, for theavoidance

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ofdoubt,anyProductLiabilitiesarisingfromtheuseofaUltragenyxPipelineProduct;(iv)the breach by Ultragenyx of any warranty, representation, covenant or agreement made by Ultragenyx in this Agreement; (v) the negligence, gross negligence or willfulmisconduct (includingtotheextentsuchnegligence,grossnegligenceorwillfulmisconductgivesriseto ProductLiabilitiesunderanylegaltheory)ofUltragenyx,itsAffiliateoritssublicensee,orany officer, director, employee, agent or representative thereof; except, with respect to eachof subsections(i)through(v)above,totheextentsuchLossesarisedirectlyorindirectlyfromthe negligence,grossnegligenceorwillfulmisconductofanyTakedaIndemniteeorthebreachby Takeda of any warranty, representation, covenant or agreement made by Takeda inthis Agreement. Notwithstanding the foregoing, following the execution of an ExercisedProduct License Agreement or Option Product License Agreement, the terms of such licenseagreement shallgoverntheindemnificationtermswithrespecttosuchProduct(s)thatarethesubjectof such licenseagreement.

 

17.2Indemnification by Takeda. Takeda hereby agrees to defend, indemnify andhold harmless Ultragenyx and its Affiliates and each of their respective directors, officers,employees, agents and representatives (each, an “Ultragenyx Indemnitee”) from and against any andall Losses to which any Ultragenyx Indemnitee may become subject as a result of any Claim tothe extent such Losses arise directly or indirectly out of: (i) the practice by Takeda or its Affiliateof anylicensegrantedtoitunderARTICLE3;(ii)theExploitationofaProductbyTakeda,its Affiliates or its sublicensees on or after the Effective Date, including, for the avoidance ofdoubt, anyProductLiabilitiesarisingfromtheuseonoraftertheEffectiveDateofaLicensed[***] ProductintheTakedaFieldintheTerritoryandanyLossesthatmayariseduetoTakeda,its Affiliates or its sublicensees continuing to Exploit a Compound or Product in its territory orfield thatisthesubjectmatterofaterminationbyUltragenyxpursuanttoSection15.3;(iii)the ExploitationofanyLicensed[***]Product,[***]ProductorCandidateProductbyTakeda,its AffiliatesoritslicenseesbeforetheEffectiveDate,including,fortheavoidanceofdoubt,any Product Liabilities arising from the use of a Licensed [***] Product, [***] Product orCandidate ProductbyTakeda,itsAffiliatesoritslicenseesbeforetheEffectiveDate,(iv)thebreachby Takeda of any warranty, representation, covenant or agreement made by Takeda inthis Agreement;(iv)thenegligence,grossnegligenceorwillfulmisconduct(includingtotheextent suchnegligence,grossnegligenceorwillfulmisconductgivesrisetoproductliabilityClaims underanylegaltheory)ofTakedaoritsAffiliateoritslicensee(otherthanUltragenyxorits Affiliate or sublicensee), or any officer, director, employee, agent or representativethereof; except, with respect to each of subsections (i) through (iv) above, to the extent such Lossesarise directly or indirectly from the negligence, gross negligence or willful misconduct ofany Ultragenyx Indemnitee or the breach by Ultragenyx of any warranty, representation, covenantor agreement made by Ultragenyx in this Agreement. Notwithstanding the foregoing, followingthe execution of an Exercised Product License Agreement or Option Product  LicenseAgreement, the terms of such license agreement shall govern the indemnification terms with respect tosuch Product(s) that are the subject of such licenseagreement.

 

|   | 17.3 | IndemnificationProcedures. |
|--------|------|----------------------------|

 

 

 

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(a)Notice. Promptly after a Takeda Indemnitee or an Ultragenyx Indemnitee(each, an“Indemnitee”)receivesnoticeofapendingorthreatenedClaim,suchIndemniteeshallgive written notice of the Claim to the Party from whom the Indemnitee is entitled toreceive indemnificationpursuanttoSections17.1or17.2,asapplicable(the“IndemnifyingParty”). However, an Indemnitee’s delay in providing or failure to provide such notice will not relievethe IndemnifyingPartyofitsindemnificationobligations,excepttotheextentitcandemonstrate prejudice due to the delay or lack ofnotice.

 

(b)Defense. Upon receipt of notice under Section 17.3(a) from the Indemnitee,the Indemnifying Party will have the duty to either compromise or defend, at its own expense andby counsel (reasonably satisfactory to Indemnitee), such Claim. The Indemnifying Partywill promptly (and in any event not more than twenty (20) days after receipt of theIndemnitee’s original notice) notify the Indemnitee in writing that it acknowledges its obligation toindemnify the Indemnitee with respect to the Claim pursuant to this ARTICLE 17 and of its intentioneither tocompromiseordefendsuchClaim.OncetheIndemnifyingPartygivessuchnoticetothe Indemnitee, the Indemnifying Party is not liable to the Indemnitee for the fees of other counselor anyotherexpensessubsequentlyincurredbytheIndemniteeinconnectionwithsuchdefense, otherthantheIndemnitee’sreasonablecostsofinvestigationandcooperation.However,the Indemnitee will have the right to employ separate counsel and to control the defense of aClaim at its ownexpense.

 

(c)Cooperation. The Indemnitee will cooperate fully with the IndemnifyingParty anditslegalrepresentativesintheinvestigationanddefenseofanyClaim.TheIndemnifying Party will keep the Indemnitee informed on a reasonable and timely basis as to the status ofsuch Claim(totheextenttheIndemniteeisnotparticipatinginthedefenseofsuchClaim)and conduct the defense of such Claim in a prudentmanner.

 

(d)Settlement. If an Indemnifying Party assumes the defense of a Claim,no compromise or settlement of such Claim may be effected by the Indemnifying Party withoutthe Indemnitee’swrittenconsent(whichconsentwillnotbeunreasonablywithheld,conditionedor delayed),unless:(i)thereisnofindingoradmissionofanyviolationoflaworanyviolationof the rights of any person and no effect on any other claims that may be made againstthe Indemnitee; (ii) the sole relief provided is monetary damages that are paid in full bythe Indemnifying Party; and (iii) the Indemnitee’s rights under this Agreement are notadversely affected. If the Indemnifying Party fails to assume defense of a Claim within a reasonabletime, the Indemnitee may settle such Claim on such terms as it deems appropriate with the consentof the Indemnifying Party (which consent shall not be unreasonably withheld, conditionedor delayed), and the Indemnifying Party will be obligated to indemnify the Indemnitee forsuch settlement as provided in this ARTICLE17.

 

17.4Insurance. Each Party shall, at its own expense, procure and maintain during theTerm and for a period of five (5) years thereafter, insurance policy/policies, including productliability insurance,adequatetocoveritsobligationshereunderandwhichareconsistentwithnormal business practices of prudent companies similarly situated. Such insurance shall not be construedtocreatealimitofaParty’sliabilitywithrespecttoitsindemnificationobligations

 

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under this ARTICLE 17. Each Party shall provide the other Party with written evidence ofsuch insurance or self-insurance upon request. Each Party shall provide the other Party withprompt written notice of cancellation, non-renewal or material change in such insurance orself- insurance that could materially adversely affect the rights of such other Party hereunder,and shallprovidesuchnoticewithinthirty(30)daysafteranysuchcancellation,non-renewalor materialchange.

 

17.5Limitation of Liability. EXCEPT FOR A PARTY’S OBLIGATIONS SET FORTHIN THISARTICLE17,ANDANYBREACHOFARTICLE14(CONFIDENTIALITY),INNO EVENTWILLEITHERPARTYBELIABLETOTHEOTHERPARTY(ORTHEOTHER PARTY’S AFFILIATES OR SUBLICENSEES) IN CONNECTION WITHTHIS AGREEMENT FOR LOST REVENUE, LOST PROFITS, LOST SAVINGS, LOSS OFUSE, DAMAGE TO GOODWILL, OR ANY CONSEQUENTIAL, INCIDENTAL,SPECIAL, EXEMPLARY, PUNITIVE OR INDIRECT DAMAGES UNDER ANYTHEORY, INCLUDING CONTRACT, NEGLIGENCE, OR STRICT LIABILITY, EVEN IFTHAT PARTY HAS BEEN PLACED ON NOTICE OF THE POSSIBILITY OF SUCHDAMAGES.

 

ARTICLE 18  –MISCELLANEOUS

 

18.1HSR Act.

 

(a)Each of Ultragenyx and Takeda shall, within ten (10) Business Daysafter Execution Date, file with the United States Federal Trade Commission and the Antitrust Division oftheUnitedStatesDepartmentofJustice,anyHSRFilingrequiredofitundertheHSRAct with respect to the subject matter of this Agreement, which forms shall specifically requestearly termination of the initial HSR Act waiting period. The Parties will cooperate with one anotherto theextentnecessaryinthepreparationofanysuchHSRFiling.ThePartiesheretocommitto instruct their respective counsel to cooperate with each other and use good faith, diligentefforts tofacilitateandexpeditetheidentificationandresolutionofanysuchissuesand,consequently, theexpirationoftheapplicableHSRActwaitingperiod,suchgoodfaithdiligenteffortsto include counsel’s undertaking: (i) to keep each other appropriately informed ofcommunications receivedfromandsubmittedtopersonnelofthereviewingantitrustauthority;and(ii)toconfer witheachotherregardingappropriatecontactswithandresponsetopersonneloftheUnited States Federal Trade Commission and the Antitrust Division of the United States Departmentof Justice.EachPartywillberesponsibleforitsowncostsandexpensesandUltragenyxwillbe responsibleforallfilingfeesassociatedwithanyHSRFiling.InrespectofanyHSRFiling, eachofUltragenyxandTakedawilluseitsgoodfaith,diligenteffortstoeliminateanyconcern on the part of any court or governmental authority regarding the legality of theproposed transaction, including cooperating in good faith with any government investigation andthe promptproductionofdocuments,information,andwitnessesrequestedinthecourseofsuchof anysuchinvestigation,includingthosecontainedinaRequestforAdditionalInformationand Documentary Materials (as that term is defined in the HSR Act), and to cause the EffectiveDate ofthisAgreementtooccurassoonaspractical,asprovidedinSection18.1(b).Nothinginthis Section shall require either Party to consent to the divestiture or other disposition of any of itsor itsAffiliates’assetsortoconsenttoanyotherstructuralorconductremedy,andeachPartyand

 

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its Affiliates shall have no obligation to contest, administratively or in court, any ruling, orderor otheractionoftheUnitedStatesFederalTradeCommissionandtheAntitrustDivisionofthe United States Department of Justice or any Third Party respecting the transactionscontemplated by thisAgreement.

 

(b)Except for the specific provisions expressly identified in Section 18.1(c),this Agreementshallnotbeeffectiveuntilthe(i)theHSRConditionsaremetand(ii)theearlierof

(A)thedateonwhichtheTaxConditionsaremet,or(B)July18,2016,atwhichtimethis Agreement shall be effective automatically in its entirety (such date the “EffectiveDate”).

 

(c)Notwithstanding Section 18.1(b) and anything in this Agreement to thecontrary, thefollowingprovisionsofthisAgreementshallbeinfullforceandeffectasoftheExecution Date: Sections 14.5 (Publicity) and 14.6 (Securities Filings), ARTICLE 1 (Definitions)and ARTICLE 18 (other than Sections 18.2, 18.5 and 18.6)(Miscellaneous).

 

(d)If the Effective Date has not occurred within one hundred eighty (180)days followingtheExecutionDate,orsuchdateasthePartiesmaymutuallyagree,thisAgreement may be terminated by either Party on written notice to theother.

 

|   | 18.2 | Exports and Restrictions onCompetition. |
|--------|------|-----------------------------------------|

 

(a)Exports.ExceptasprovidedinthisAgreement,eachPartyshallnot,andshall cause its Affiliates and sublicensees not to, whether directly or indirectly through a ThirdParty, export, distribute orsell:

 

(i)in the case of Ultragenyx, (A) Licensed [***] Products outsidethe Ultragenyx Field or outside the Territory, (B) Licensed Analog Products outside theLicensed Field or outside the Territory, (C) Research Products unless and until an Option ProductLicense Agreement is executed for such Products and then only in accordance with such OptionProduct LicenseAgreement;providedfurtherthat,iftheTakedaOptionhasbeenexercisedforagiven Product Ultragenyx may not export, distribute or sell such Product in the TakedaTerritory.

 

 

 

Territory.
|   | (ii) |  |
|--------|------|--|

|   |  | In the case of Takeda, Ultragenyx Pipeline Products outside of theTakeda |
|--------|--|--------------------------------------------------------------------------|

 

 

(b)Non-Competition Obligations.  Ultragenyx shall not, and shall causeits Affiliates not to, whether directly or indirectly through a Third Party (including anysublicensee), (i) develop a Competing Product in the Territory at any time prior to the [***] of the Effective Date or (ii) commercialize a Competing Product in the Territory at any time prior to the [***] of the First Commercial Sale of a Product. Ultragenyx shall not be in breach of this Section 18.2(b) by acquiring, merging or consolidating with a Third Party which develops or commercializes a Competing Product; provided, however, that in the event Ultragenyx acquires such Competing Product, it must, unless Takeda agrees to the contrary, within [***] of such acquisition, either divest such Competing Product to a Third Party, discontinue the development or commercialization of such Competing Product, or, if applicable, terminate

 

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this Agreement with respect to the Licensed Product that is the subject of competitionin accordance with Section15.4.

 

18.3Notice.Anynotice,request,orothercommunicationpermittedorrequiredunderthis Agreement shall be in writing, shall refer specifically to this Agreement and shall behand delivered or sent by a recognized overnight delivery service, costs prepaid, or by facsimile(with transmissionconfirmed),tothefollowingaddressesortosuchotheraddressesasaPartymay designate by written notice in accordance with this Section18.3:

 

If toTakeda:

 

Takeda Pharmaceutical CompanyLimited 1-1, Doshomachi4-chome,

Chuo-ku, Osaka540-8645

Attention: Head of Global BusinessDevelopment Facsimile: (+81)3-3278-2323

 

Copyto:

 

Takeda Pharmaceuticals U.S.A.,Inc. One TakedaParkway

Deerfield, IL60015

Attention: General Counsel, LegalDepartment Facsimile:224-554-7831

 

If toUltragenyx:

Ultragenyx PharmaceuticalInc. 60 LeveroniCourt

Novato, CA94949

Attention: Chief BusinessOfficer

 

Copyto:

CooleyLLP

3175 HanoverStreet Palo Alto, CA94304 Attention: GlenSato Fax:650-849-7400

 

18.4Designation of Affiliates. Each Party may discharge any obligations and exerciseany rights hereunder through delegation of its obligations or rights to any of its  Affiliates. Each PartyherebyguaranteestheperformancebyitsAffiliatesofsuchParty’sobligationsunderthis Agreement,andshallcauseitsAffiliatestocomplywiththeprovisionsofthisAgreementin connectionwithsuchperformance.AnybreachbyaParty’sAffiliateofanyofsuchParty’s obligationsunderthisAgreementshallbedeemedabreachbysuchParty,andtheotherParty

 

 

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mayproceeddirectlyagainstsuchPartywithoutanyobligationtofirstproceedagainstsuch Party’sAffiliate.

 

|   | 18.5 | Change of Control ofUltragenyx. |
|--------|------|---------------------------------|

 

(a)Notice. Ultragenyx (or its successor) shall provide notice to Takeda  ofany ChangeofControlofUltragenyxwithin[***]BusinessDaysafterthedateuponwhichthe Ultragenyx Change of Control closes or otherwise becomeseffective.

 

(b)Effects of Change of Control of Ultragenyx. In the event of a  Changeof Control of Ultragenyx, the following shallapply:

 

(i)The Takeda Option Term applicableintheeventofaChangeofControl of Ultragenyx shallapply.

 

(ii)Onorbeforethedatethatisone hundred eighty (180) days after the date upon which a Change of Control of Ultragenyx closes or otherwise becomes effective, Takeda may take or require that Ultragenyx, or its successor, take or perform, as applicable, any one or more of the following actions: (A) Ultragenyx and its successor shall adopt reasonable written procedures, approved by Takeda, to prevent disclosure of Takeda’s Confidential Information, (B) the definition of Licensed Analog Compounds shall be amended to be limited to those Compounds listed on Exhibit 1.99 as of the effective date of the Ultragenyx Change of Control, provided that if Ultragenyx has paid costs in connection with the Development of a Licensed Analog Compound, such Licensed Analog Compound shall be listed on Exhibit 1.99, as amended, (C) Section 5.1 shall be amended to require Takeda’s written consent in order for Ultragenyx and its successor to exercise its rights to co-Commercialize and Co-Develop thereunder to the extent Ultragenyx has not previously exercised such right(s), and (D) Takeda may terminate, in its sole discretion, one or more of the ongoing Validation Research Plans and Research Plans, in which case any associated licenses to Ultragenyx and its successor under Section 6.5 shall terminate, and any Research Products designated by Takeda shall be deemed Terminated Products; provided that to the extent that Ultragenyx has paid costs in connection with the Development of a Research Product on or before such date, such Validation Research Plan or Research Plan, as applicable, and associated licenses to Ultragenyx or its successor shall continue in full force and effect and such Research Products shall not be deemed Terminated Products under this Section 18.5(b)(ii). For clarity, termination pursuant to this Section 18.5(b)(ii) shall not terminate the Collaboration Term for any purposes under this Agreement other than the foregoing clause (D).

 

18.6Force Majeure. Both Parties shall be excused from the performance of theirobligations under this Agreement to the extent that such performance is prevented by Force Majeure andthe nonperforming Party promptly provides notice of the prevention to the other Party. Suchexcuse shall be continued so long as the condition constituting Force Majeure continues andthe nonperforming Party takes reasonable efforts to remove the condition. Notwithstandingthe foregoing,aPartyshallnotbeexcusedfrommakingpaymentsowedhereunderbecauseofa Force Majeure affecting such Party. If a Force Majeure persists for more than ninety (90)days,

 

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thenthePartieswilldiscussingoodfaiththemodificationoftheParties’obligationsunderthis Agreement in order to mitigate the delays caused by such ForceMajeure.

 

18.7Assignment. Prior to the Effective Date, neither Party may assign or transferthis Agreement or any rights or obligations hereunder without the prior written consent of theother. On or after the Effective Date, neither Party may assign or transfer this Agreement or anyrights or obligations hereunder without the prior written consent of the other; provided that nosuch consentisrequiredfor(a)assignmenttoAffiliatesor(b)inconnectionwiththesaleofallor substantially all of the assets to which this Agreement relates, whether in a merger, sale ofstock, sale of assets or any other transaction (subject, in the case of Ultragenyx, to Section 18.5).Any successororassigneeofrightsand/orobligationspermittedhereundershall,inwritingtothe otherParty,expresslyassumeperformanceofsuchrightsand/orobligations.Anypermitted assignment shall be binding on the successors of the assigning Party. Any assignmentor attemptedassignmentbyeitherPartyinviolationofthetermsofthisSectionshallbenull,void and of no legaleffect.

 

18.8Severability. If any one or more of the provisions of this Agreement is held to beinvalid or unenforceable by any court of competent jurisdiction from which no appeal can be or istaken, theprovisionshallbeconsideredseveredfromthisAgreementandshallnotservetoinvalidate any remaining provisions hereof. The Parties shall make a good faith effort  to  replaceany invalidorunenforceableprovisionwithavalidandenforceableonesuchthattheobjectives contemplated by the Parties when entering this Agreement may berealized.

 

18.9EnglishLanguage.ThisAgreementshallbewrittenandexecutedin,andallother communicationsunderorinconnectionwiththisAgreement,shallbeintheEnglishlanguage. Anytranslationintoanyotherlanguageshallnotbeanofficialversionthereof,andintheevent of any conflict in interpretation between the English version and such translation, theEnglish version shallcontrol.

 

18.10Waiver and Non-Exclusion of Remedies.  Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no suchwaiver shallbeeffectiveunlesssetforthinawritteninstrumentdulyexecutedbyoronbehalfofthe Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver ofany otherrighthereunderorofanyotherbreachorfailurebysuchotherPartywhetherofasimilar nature or otherwise. The rights and remedies provided herein are cumulative and do notexclude any other right or remedy provided by Applicable Laws or otherwise available exceptas expressly set forthherein.

 

18.11Further Assurance. Each Party shall duly execute and deliver, or cause to beduly executedanddelivered,suchfurtherinstrumentsanddoandcausetobedonesuchfurtheracts and things, including the filing of such assignments, agreements, documents, and instruments,as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposeshereof.

 

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18.12RelationshipoftheParties.ItisexpresslyagreedthatTakeda,ontheonehand,and Ultragenyx, on the other hand, shall be independent contractors and that the relationshipbetween thetwoPartiesshallnotconstituteapartnership,jointventureoragency.NeitherTakedanor Ultragenyx shall have the authority to make any statements, representations or commitmentsof anykind,ortotakeanyactionwhichshallbebindingontheother,withoutthepriorwritten consent of the other Party to do so. All persons employed by a Party shall be employees ofthat Party and not of the other Party and all costs and obligations incurred by reason ofsuch employmentshallbefortheaccountandexpenseofsuchParty.Forclarity,(a)ifTakeda provides Research Support for an Ultragenyx Pipeline Product (other than Exercised Products)or LicensedOptionProduct(inconnectionwithanOptionProductLicenseAgreement),Takeda shall be deemed an independent contractor in the performance of such Research Support and(b) in no case shall Takeda provide Research Support with respect to a LicensedProduct.

 

18.13Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and thesame instrument. This Agreement may be executed by facsimile, .pdf or otherelectronically transmittedsignaturesandsuchsignaturesshallbedeemedtobindeachPartyheretoasifthey were the originalsignatures.

 

18.14Construction. Except where the context otherwise requires, wherever used, thesingular shallincludetheplural,thepluralthesingular,andtheuseofanygendershallbeapplicableto all genders. Whenever this Agreement refers to a number of days, such number refers to calendar days. The terms “including,” “include,” or “includes” as used herein shallmean “including, but not limited to,” and shall not limit the generality of any descriptionpreceding such term. The language of this Agreement shall be deemed to be the language mutuallychosen by the Parties and no rule of strict construction shall be applied against either Party hereto.Each Party represents that it has been represented by legal counsel in connection with thisAgreement and acknowledges that it has participated in the drafting hereof. In interpreting and applyingthe terms and provisions of this Agreement, the Parties agree that no presumption will applyagainst the Party which drafted such terms andprovision.

 

18.15Governing Laws. This Agreement was prepared in the English language,which language shall govern the interpretation of, and any dispute regarding, the terms ofthis Agreement.ThisAgreementandalldisputesarisingoutoforrelatedtothisAgreementorany breachhereofshallbegovernedbyandconstruedunderthelawsoftheStateofNewYork, withoutgivingeffecttoanychoiceoflawprinciplesthatwouldrequiretheapplicationofthe laws of a differentstate.

 

18.16EntireAgreement.ThisAgreement,includingtheExhibitshereto,andtheCommon StockPurchaseAgreementsetforththecomplete,finalandexclusiveagreementandallthe covenants, promises, agreements, warranties, representations, conditions andunderstandings betweenthePartiesheretowithrespecttothesubjectmatterhereofandsupersedes,asofthe Execution Date, all prior and contemporaneous agreements and understandings betweenthe Partieswithrespecttothesubjectmatterhereof;provided,that,untiltheEffectiveDate,the ConfidentialityAgreementshallcontinueinfullforceandeffectinaccordancewithitsterms.

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Except as provided in the Common Stock Purchase Agreement, there are nocovenants, promises,agreements,warranties,representations,conditionsorunderstandings,eitheroralor written, between the Parties other than as are set forth herein and therein. Nosubsequent alteration,amendment,changeoradditiontothisAgreementshallbebindingupontheParties unless reduced to writing and signed by an authorized officer of each Party. In the event ofany inconsistency between the body of this Agreement and the Exhibits to this Agreement,the Common Stock Purchase Agreement, or any subsequent agreements ancillary to thisAgreement, unless otherwise expressly stated to the contrary in such Exhibit, Common StockPurchase Agreement or subsequent ancillary agreement, the terms contained in this Agreementshall control.

 

18.17Headings. The headings of each Article and Section in this Agreement havebeen inserted for convenience of reference only and are not intended to limit or expand  onthe meaning of the language contained in the particular Article orSection.

 

SIGNATURE PAGEFOLLOWS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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THIS AGREEMENT is executed by the authorized representatives of the Parties as ofthe ExecutionDate.

 

 

|                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ULTRAGENYXPHARMACEUTICAL    INC.                                                                                                                                                                                                                                                                                                                         | TAKEDAPHARMACEUTICALCOMPANYLIMITED                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
| By       /s/ Emil Kakkis                                                   |  

 

 

By    /s/ Misako Hamamura                                                                                          |
| Name:  Emil Kakkis                                                                                                                                                                                                                                                                                                                                       | Name:  Misako Hamamura                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
| Title:  CEO                                                                                                                                                                                                                                                                                                                                              | Title:  Head of JP Strategy & BD                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |
|                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                  

                                

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

{Signature Page to License  and  CollaborationAgreement}

 

 

 

 

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Exhibit1.6(i)

 

[***]

 

 

 

 

 

 

ChemicalName:  [***]

 

Molecular Formula:[***]

Molecular Weight:[***]

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Exhibit1.6(iii)

 

[***]

 

 

 

 

 

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Exhibit1.82

 

Initial [***] DevelopmentPlan

 

 

Initial Development PlanFramework

 

[***]

EstimatedTimeline

 

[***]

 

Development Activities andBudget

 

[***]

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Exhibit 1.91

KnowledgeGroup

 

 

Ultragenyx PositionTitles

 

Tom Kassberg, SVP and Chief BusinessOfficer Shalini Sharp, SVP and Chief FinancialOfficer Sunil Agarwal, SVP and Chief MedicalOfficer Cori Leonard, VP,Regulatory

Yael Weiss, Executive Director, Search and Evaluation, BusinessDevelopment Rob Anstey, Senior Director, BusinessDevelopment

 

 

Takeda PositionTitles

 

[***]

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Exhibit1.94

 

[***]

 

 

 

 

 

 

 

 

 

|   | 2 | Chemical Name:  [***] |   |
|--------|--------|---------------------------------|--------|

|   | 2 | Molecular Formula:   [***] |   |
|--------|--------|--------------------------------------|--------|

|   | 2 | Molecular Weight:  [***] |   |
|--------|--------|--------------------------|--------|

 

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Exhibit 1.99

Licensed AnalogCompounds

[***]

 

 

 

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Exhibit 1.137

Preexisting Third PartyIP

[***]

 

[3 pages omitted]

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Exhibit 1.141

ProductINDs

[***]

 

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Exhibit 1.168

TakedaPatents

Licensed [***]Patent

 

|                     |                       |                          |               |        |
|---------------------|-----------------------|--------------------------|---------------|--------|
| Patent /Publication | Priority /Application | Inventor(s) /Assignee(s) | Title /Claims | Status |
| [***]               | [***]                 | [***]                    | [***]         | [***]  |

 

[2 pages omitted]

 

 

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Exhibit 1.188

UltragenyxPatents

 

 

Ultragenyx [***]Patents

 

[***]

 

Ultragenyx [***] Patents

 

 

[***]

 

 

[3 pages omitted]

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Exhibit1.195

 

 

[***]

 

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Exhibit 6.1

ListedCompounds

[***]

 

 

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Exhibit 6.3(a)

[***] Research Plan

[***]

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Exhibit 6.10(b)

 

[***]

 

[4 pages omitted]

 

 

 

 

 

 

 

 

 

 

 

 

 

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Exhibit 13.2(b)

 

[***]

 

[4 pages omitted]

 

 

 

 

 

 

 

 

 

 

 

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Exhibit 14.5

Form of PressRelease

 

 

 

Contact Ultragenyx PharmaceuticalInc. Investors &Media

RyanMartins 844-758-7273

For Takeda Pharmaceutical CompanyLimited: Tsuyoshi Tada –Japan tsuyoshi.tada@takeda.com

+81332782417

 

Julia Ellwanger –USA julia.ellwanger@takeda.com

+1-224-554-7681

 

 

 

UltragenyxandTakedaenterintoaCollaborationtoDevelopandCommercializeTherapiesforRare GeneticDiseases

 

Ultragenyx to license and develop one or more product candidates fromTakeda Takeda to make equity investment in Ultragenyx to funddevelopment

NOVATO, CA, June 7, 2016 and OSAKA, JAPAN, June 8, 2016 – Ultragenyx Pharmaceutical Inc.(NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare andultra- rare genetic diseases, and Takeda Pharmaceutical Company Limited (TSE: 4502), today announceda strategic partnership to develop and commercialize therapies to treat rare geneticdiseases.

Ultragenyx will initially receive an exclusive license to one preclinical Takeda product candidate in apre- determined field of use, and will have an exclusive option to co-develop and co-commercializethe product candidate in additional therapeutic areas. The companies have also established afive-year research collaboration in which Ultragenyx will have the option to license up to five additionalTakeda

 

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product candidates for rare diseases after the parties agree on and conduct initial validationactivities under the purview of a Joint ResearchCommittee.

“This broad collaboration provides Ultragenyx with a product opportunity that is approachingclinical- stage development as well as a potential continued source of new product candidates that will helpusachieve our goal of bringing a new therapy into the clinic every one to two years,” said Emil D.Kakkis, MD, PhD, Chief Executive Officer of Ultragenyx. “Takeda has an impressive early pipeline oftherapies with potential across a number of rare genetic diseases, and we are pleased that Takeda has chosento partner with us to bring these therapies to patients with rare diseases that have few or notreatment options.”

"Ultragenyx is a rapidly emerging rare disease company, led by a highly experienced andsuccessful management team," said Andrew Plump, M.D., Ph.D., Chief Medical and Scientific Officer ofTakeda. “This partnership provides Takeda access to Ultragenyx’s strong patient-centric developmentand regulatory capabilities in the rare disease space, and could create significant value for both companiesbydelivering important new therapies topatients.”

Takeda will receive an exclusive option to commercialize any licensed products resulting fromthe collaboration in Asia, including Japan. In addition, Takeda receives an option to exclusively licenseone Ultragenyx pipeline product in Japan. Each company will receive potential development andsalesmilestone payments and royalties on net sales of licensed products by the otherparty.

Takeda will invest up to $65 million in Ultragenyx in two tranches, the first of which will comprisea

$25million stock purchase along with a $15 million cash premium at closing. This will be followedat Ultragenyx’s option, within 12 months, by a second equity purchase of $25million with noadditional premium. A potential third equity investment by Takeda is contingent upon Ultragenyx achievinga specific development milestone on a second asset. No additional financial details weredisclosed.

The completion of the transactions are subject to Hart-Scott-Rodino Antitrust Improvements Act of1976 (HSR) review and the satisfaction of other customary closingconditions.

 

AboutUltragenyx

 

Ultragenyx is a clinical-stage biopharmaceutical company committed to bringing to marketnovel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitatinggenetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidateswith the potential to address diseases for which the unmet medical need is high, the biology for treatmentis clear, and for which there are no approvedtherapies.

The company is led by a management team experienced in the development and commercializationof rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficientdrug development, with the goal of delivering safe and effective therapies to patients with theutmost urgency.

 

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For more information on Ultragenyx, please visit the company’s website atwww.ultragenyx.com.

 

AboutTakeda

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceuticalcompany committed to bringing better health and a brighter future to patients by translating science intolife- changing medicines. Takeda focuses its research efforts on oncology, gastroenterology andcentral nervous system therapeutic areas. It also has specific development programs in specialtycardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally andwith partners to stay at the leading edge of innovation. New innovative products, especially inoncology, central nervous system and gastroenterology, as well as its presence in emerging markets, fuelthe growthofTakeda.Morethan30,000Takedaemployeesarecommittedto improvingqualityoflifefor patients, working with our partners in health care in more than 70 countries. For more information,visit http://www.takeda.com/news.

 

Ultragenyx Forward-LookingStatements

 

Exceptforthehistoricalinformationcontainedherein,thematterssetforthinthispressrelease, including statements regarding the potential to develop the licensed product candidate inadditional therapeutic areas, as well as the potential to develop additional rare disease targets pursuant tothe collaboration and the ability to bring new therapies to clinic, are forward-looking statementswithin themeaningofthe"safeharbor"provisionsofthePrivateSecuritiesLitigationReformActof1995. Suchforward-lookingstatementsinvolvesubstantialrisksanduncertaintiesthatcouldcauseour development programs, future results, performance or achievements to differ significantlyfrom those expressed or implied by the forward-looking statements. Such risks and uncertaintiesinclude, among others, the satisfaction of the HSR requirements and the impact on the timing of theclosing, whetheranyproductswillbesuccessfullydevelopedandcommercializedfromthecollaboration, uncertainties inherent in the drug development process and other matters that could affectthe potential for success of the collaboration, including the sufficiency of existing cash, cashequivalents andshort-terminvestmentstofundoperations.Ultragenyxundertakesnoobligationtoupdateorreviseanyforward-lookingstatements.Forafurtherdescriptionoftherisksanduncertaintiesthat couldcauseactualresultstodifferfromthoseexpressedintheseforward-lookingstatements,as well as risks relating to the business of the company in general, see Ultragenyx's Quarterly ReportonForm 10-Q filed with the Securities and Exchange Commission on March 10 2016, and itssubsequent periodic reports filed with the Securities and ExchangeCommission.

 

Takeda Forward-LookingStatements

 

This press release contains “forward-looking statements.” Forward-looking statements includeall statements other than statements of historical fact, including plans, strategies and expectationsfor the future, statements regarding the expected timing of filings and approvals relating tothe transaction,theexpectedtimingofthecompletionofthetransaction,theabilitytocompletethe transactionortosatisfythevariousclosingconditions,futurerevenuesandprofitabilityfromor

 

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growthoranyassumptionsunderlyinganyoftheforegoing.Statementsmadeinthefuturetense, andwordssuchas“anticipate,”“expect,”“project,”“continue,”“believe,”“plan,”“estimate,”“pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,”“will,” “may,” “should,” and similar expressions are intended to qualify as forward-lookingstatements. Forward-lookingstatementsarebasedonestimatesandassumptionsmadebymanagementthat are believed to be reasonable, though they are inherently uncertain and difficult to predict.Investors and security holders are cautioned not to place undue reliance on these forward-lookingstatements.

 

Forward-looking statements involve risks and uncertainties that could cause actual resultsorexperiencetodiffermateriallyfromthatexpressedorimpliedbytheforward-lookingstatements. Someoftheserisksanduncertaintiesinclude,butarenotlimitedto:requiredregulatoryapprovals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing ofthe transaction may not be satisfied; competitive pressures and developments; applicable lawsand regulations; the success or failure of product development programs; actions ofregulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regardingthe safety or efficacy of marketed products or product candidates indevelopment.

 

 

The forward-looking statements contained in this press release speak only as of the date of thispress release, and neither Ultragenyx nor Takeda undertakes any obligation to revise or updateany forward-lookingstatementstoreflectnewinformation,futureeventsorcircumstancesafterthe dateoftheforward-lookingstatement.Ifoneormoreofthesestatementsisupdatedorcorrected, investors and others should not conclude that additional updates or corrections will bemade.

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