**Exhibit 10.35**

 

**CONFIDENTIAL TREATMENT REQUESTEDWITH RESPECT TO CERTAIN PORTIONS HEREOFDENOTED WITH “***”**

 

 

**COLLABORATIONAND LICENCE AGREEMENT**

 

 

**DATED 15AUGUST 2005**

 

 

**AMONG**

 

**UCB S.A.**

 

**AND**

 

**IMCLONESYSTEMS INCORPORATED**

 

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**CONTENTS**

 

 
| **Article** |                                          |   |
|-------------|-----------------------------------------------|--------|
|        |                                          |
| 1.          | Definitions                                   |   |
| 2.          | Scope of Collaboration                        |   |
| 3.          | Collaboration Management                      |   |
| 4.          | Development of Antibody  Products             |   |
| 5.          | Regulatory Affairs                            |   |
| 6.          | Commercialisation  of Antibody Products       |   |
| 7.          | Manufacture and  Supply                       |   |
| 8.          | INDEPENDENT  IndicationS                      |   |
| 9.          | Grant of Rights                               |   |
| 10.         | Rights in  Intellectual Property              |   |
| 11.         | Confidentiality  and Non-Use                  |   |
| 12.         | Term and Termination                          |   |
| 13.         | Representations,  Warranties and Covenants    |   |
| 14.         | Indemnification  and Insurance                |   |
| 15.         | Dispute Resolution                            |   |
| 16.         | Imclone  Option; Competing Products           |   |
| 17.         | Miscellaneous                                 |   |
| Schedule 1: | Patent Rights And Trademarks                  |   |
| Schedule 2: | Financial Planning, Accounting and  Reporting |   |
| Schedule 3: | Development Plan                              |   |
| Schedule 4: | Existing Supply Agreements                    |   |
|             |                                               |        |  |  |

 

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**COLLABORATIONAND LICENCE AGREEMENT**

 

**THIS COLLABORATION AND LICENCEAGREEMENT** (this **Agreement**)is entered into on 15 August 2005 (the **EffectiveDate**)

 

**BETWEEN**:

 

(1)                                  **UCB, S.A.**, a Belgian company (Company No. 0403 053 608) ofAllée de la Recherche, 60, 1070 Brussels, Belgium, 1070 (**UCB**); and

 

(2)                                  **IMCLONE SYSTEMS INCORPORATED**, a Delaware corporation, of 180 Varick Street,6th Floor, New York, NY 10014, USA (**ImClone**).

 

**RECITALS**:

 

(A)                              UCB andImClone have identified antibodies that bind to, and are directed against, KDRas having potential value in oncology and each of them has experience andexpertise in the development of antibody-based pharmaceuticals.

 

(B)                                TheParties believe that entering into this Agreement is in their mutual interestand in the interest of the public, and that collaboration under the terms ofthis Agreement will improve the prospects of success of the approval and deliveryof Antibody Products, will lead to effective and efficient Development,Manufacturing and Commercialisation of Antibody Products and will be anefficient and cost effective way of promoting Antibody Products to the benefitof consumers.

 

(C)                                UCB andImClone each wishes to grant to the other certain licences under each Party’srespective intellectual property rights to permit the other Party toparticipate in mutually beneficial collaborative Development, Manufacturing andCommercialisation of Antibody Products.

 

**NOW THEREFORE**, inconsideration of the foregoing premises and for other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged,UCB and ImClone, intending to be legally bound, do hereby agree as follows:

 

# **1.****                                     ****DEFINITIONS**

# ** **

## **1.1****                              **Whenused in this Agreement, each of the following terms shall have the meanings setout in this Article 1.1:

##  

**1121B** means anAntibody as disclosed in PCT Application PCT\US03\06459.

 

**AdversarialProsecution Action** means (i) with respect to any Patent Rights,any patent interferences, re-examinations, reissues, revocations, observationsor oppositions lodged against such Patent Rights; and (ii) with respect to anyTrademark, any trademark interferences, observations, oppositions, rectifications,revocations or invalidations lodged against such Trademark.

 

**Affiliate** means anycorporation, company, partnership, joint venture or other entity whichcontrols, is controlled by, or is under common control with a Party.  For

 

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purposes of this definition and the definitionof “Change of Control” only, control shall be presumed to exist if one of thefollowing conditions is met: (a) in the case of corporate entities, direct orindirect ownership of at least fifty per cent. (50%) of the stock or shareshaving the right to vote for the election of directors, and (b) in the case ofnon-corporate entities, direct or indirect ownership of at least fifty percent. (50%) of the equity interest with the power to direct the management andpolicies of such non-corporate entities. The Parties acknowledge that in the case of certain entities organisedunder the laws of certain countries, the maximum percentage ownership permittedby law for a foreign investor may be less than fifty per cent. (50%), and thatin such case such lower percentage shall be substituted in the precedingsentence, *provided that* suchforeign investor has the power to direct the management and policies of suchentity.

 

**AgreedIndications** means the oncology Indications set forth in theoutline for the Development Plan and thereafter the Development Plan and suchother oncology Indications as are recommended by the Parties pursuant toArticle 4.7 and approved by the Collaboration Committee pursuant to Article3.3(a).  Agreed Indications shall includeany Converted Agreed Indication.

 

**Antibody** means anyantibody [***]  [Confidential Treatment Required]

 

**AntibodyProduct** means (i) a pharmaceutical product that includesCDP-791 as the sole active ingredient, and (ii) any other pharmaceuticalproduct containing CDP-791 or another Antibody that binds to, and is directedagainst, KDR (including a Competing Product) that is agreed between the Partiesin accordance with Article 2.1(b) or 16.5.

 

**ApplicableLaw** means the applicable laws, rules and regulations(including any rules, regulations, guidelines or other requirements of theRegulatory Authorities, including GMP, GLP and GCP) that may be in effect fromtime to time in the Territory, to the extent applicable.

 

**BusinessDay** means a day other than a Saturday or Sunday on whichbanking institutions in both New York, New York USA and London, England areopen for business.

 

**CalendarQuarter** means each of the three (3) month periods beginning1st January, 1st April, 1st July and 1st October, *provided* that the first Calendar Quarter during the Termshall commence on the Effective Date and end on 30th September, 2005 and **Quarterly** shall have a correspondingmeaning.

 

**CDP-791** means theAntibody as disclosed in the IMPD EudraCT number 2005-00173130 filed byCelltech R&D Limited.

 

**Change ofControl** means, with respect to a Party, a change of theentity that has control (directly or indirectly) of that Party.  For the purposes of this definition, controlshall have the meaning given to it in the definition of “Affiliate”.

 

**ClinicalStudy** means (i) a human clinical study in any country thatis intended to initially evaluate the safety or pharmacological effect of anAntibody Product in subjects or that would otherwise satisfy requirements of 21C.F.R. 312.21(a), or its

 

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equivalent outside the United States (a **Phase I Clinical Study**), (ii) a humanclinical study in any country that is intended to initially evaluate theeffectiveness of an Antibody Product for a particular indication or indicationsin patients with the disease or indication under study or that would otherwisesatisfy requirements of 21 C.F.R. 312.21(b), or its equivalent outside theUnited States (a **Phase II Clinical Study**),(iii) a pivotal human clinical study, the principal purpose of which is toestablish safety and efficacy in patients with the disease target being studiedas required in 21 C.F.R. 312, or similar clinical studies prescribed by theRegulatory Authorities in a country other than the United States whether or notsuch study is a traditional Phase III study (a **Phase III Clinical Study**) or (iv) a human clinical study thatis required or requested by a Regulatory Authority as a condition of or inconnection with obtaining or maintaining a Regulatory Approval (whethercommenced prior to or after receipt of such Regulatory Approval) (a **Phase IV Clinical Study**).  A Clinical Study shall be deemed to becomplete on the date specified by the JDT in accordance with Article 4.6(b)(v).

 

**ClinicalSupplies** means supplies of ICH and GMP compliant AntibodyProducts in suitable form for use in Development or Post-Approval Studies.

 

**CollaborationCommittee** means the committee formed pursuant to Article 3.1.

 

**CommercialSupplies** means supplies of Antibody Products in suitable finalpackaged form, in accordance with a specification agreed by the Parties,Manufactured in compliance with GMP, and ready to be offered for commercialsale for use in the Field in the Territory by ImClone, UCB, their Affiliates,sublicensees and Distributors (or any of them).

 

**Commercialisation** or **Commercialise** means any and all activities(whether before or after Regulatory Approval) directed to marketing, Detailingand Promotion (or any of those activities) of an Antibody Product forcommercial sale, and shall include Post-Approval Studies, pre-launch andpost-launch marketing, Promoting, Detailing, distributing, offering to sell andselling an Antibody Product, importing, exporting or transporting an AntibodyProduct for sale, and interacting with Regulatory Authorities regarding theforegoing, but shall exclude Manufacturing. When used as a verb, **Commercialising**means to engage in Commercialisation and **Commercialised**shall have a corresponding meaning.

 

**CommercialisationPlan** means the comprehensive plan and overall strategy forthe Commercialisation of Antibody Products, to be prepared, updated and amendedpursuant to Article 6.5.

 

**CommerciallyReasonable****and****Diligent Efforts** means efforts andresources commonly associated with good business practice and standards in theresearch-based pharmaceutical industry to research, develop, manufacture orcommercialise (as appropriate) a product or compound of similar marketpotential at a similar stage in its product life, taking into account safety,efficacy, the competitiveness of alternative products and product candidates inthe marketplace, the patent and other proprietary position of the product, thelikelihood of Regulatory Approval given the regulatory structure involved, theprofitability of the product including the royalties payable to licensors ofPatent Rights, alternative products and product candidates and other reasonablyrelevant factors.  Commercially Reasonableand Diligent Efforts where

 

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appropriate shall be determined on amarket-by-market basis for a particular product, and the level of effort maychange over time, reflecting changes in the status of the product and themarket involved.

 

**Committee** means anyof the Collaboration Committee, JDT, JCT, JMT, JPC or any sub-team orsub-committee thereof established pursuant to this Agreement, as the case maybe.

 

**CompendiaListing** means a listing for an indication in the UnitedStates for a Product that is supported by a citation in at least one of thefollowing authoritative drug reference books: (a) the American Society ofHealth-System Pharmacists’ American Hospital Formulary Service (AHFS), or (b)the U.S. Pharmacopoeia Drug Information, or in another similar authoritativedrug reference book that is relied on by Third Party payors in authorizingreimbursement for such Product for such indication.

 

**CompetingProduct** [***]  [Confidential Treatment Required]

 

**ConfidentialInformation** means all Information and all Materials provided by aParty or its Affiliates to the other Party or its Affiliates either inconnection with the discussions or negotiations pertaining to, or in the courseof performing, this Agreement, including all Information and Materialsdeveloped during the course of Development, Commercialisation or Manufacture ofAntibody Products under this Agreement and all Information of a Party disclosedat any meeting of any Committee or disclosed through a report to or from anysuch Committee.  The terms of thisAgreement and the Joint Know-How shall be considered Confidential Informationof each Party.

 

**ContractYear** means: (a) with respect to the first Contract Year,the period beginning on the Effective Date and ending on 31st December, 2005(the **First Contract Year**); and (b)with respect to each subsequent Contract Year, the twelve (12) month periodbeginning on the day following the end of the First Contract Year and eachsucceeding twelve (12) month period.

 

**Control** or **Controlled** means, with respect to any (a)Materials or Information, or (b) intellectual property or proprietary right, ineach case the possession (whether by ownership, licence or other right, otherthan pursuant to this Agreement) by a Party or its Affiliates of the ability togrant to the other Party access and/or a licence (or sublicence) as provided inthis Agreement under such right or to such Material or Information [***]   [Confidential TreatmentRequired].

 

**Co-Promotionand Co-Promote** mean, with respect to an Antibody Product,those activities and obligations including Detailing undertaken by a ThirdParty in collaboration with a Party to encourage sales of such Antibody Productby that Party, but not including Promotion or other activities conducted byAffiliates or sublicensees in connection with sales on their own account orDistributors or Third Parties (including contract sales organisations andadvertising agencies) appointed on a subcontract basis to perform services forthe Party.

 

**Core PatentRights**means the ImClone Core Patent Rights or the UCB CorePatent Rights.

 

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**CorporateMarks**means the ImClone Company Marks and UCB Company Marks.

 

**DataPackage** means, with respect to an Antibody Product for anIndependent Indication or a Competing Product (a) for which a Drug ApprovalApplication has not been approved by the Regulatory Authorities in the UnitedStates, including the FDA, or Europe, including the EMEA, (i) a summary of allthe relevant clinical data with respect to the Independent Indication for theAntibody Product or to the Competing Product, as applicable, including anyClinical Study results and resultant data analyses, (ii) any regulatorysubmissions made to the FDA or any other Regulatory Authority by or on behalfof the Continuing Party with respect to such Independent Indication for suchAntibody Product or to such Competing Product, (iii) protocols for any ongoingClinical Studies and proposed designs for any anticipated Clinical Studies withrespect to such Independent Indication for such Antibody Product or to suchCompeting Product, (iv) a budget for the costs and expenses expected to beincurred in connection with any ongoing Development of such IndependentIndication for such Antibody Product or Competing Product and, (v) such othermaterial Information and Materials relating to such Independent Indication forsuch Antibody Product or to such Competing Product in the control of theContinuing Party that were not previously disclosed to the Non-Continuing Partyand that were relied on by the Continuing Party’s senior management indetermining to proceed with the current phase of Development of suchIndependent Indication for such Antibody Product or of such Competing Product,and (b) for which a Drug Approval Application has been approved by theRegulatory Authorities in the United States, including the FDA, or Europe,including the EMEA, a copy of such Drug Approval Application and any otherfilings made with the Regulatory Authorities with respect to the AntibodyProduct for such Independent Indication or the Competing Product.

 

**Detail** means aninteractive face-to-face contact (including a live video presentation) of asales representative, who is adequately equipped with, and knowledgeable of,applicable Promotional Materials and Product Labelling, with a physician orother medical professional licensed to prescribe drugs or other healthcareprofessional that has a significant impact or influence on prescribingdecisions including: (a) a medical professional with prescribing authority; or(b) to the extent permitted by Applicable Law, an office nurse with influenceover the pharmaceutical treatment of a patient, in which relevantcharacteristics of the applicable Antibody Product are described by the salesrepresentative in a fair and balanced manner consistent with the requirementsof this Agreement and Applicable Law, and in a manner that is customary in theindustry for the purpose of promoting a prescription pharmaceuticalproduct.  When used as a verb, Detailmeans to engage in a Detail.  A sampledrop does not constitute a Detail.

 

**Development** or **Develop** means all activities related toresearch, preclinical and other non-clinical testing, test method developmentand stability testing, toxicology, Clinical Studies other than Post-ApprovalStudies, regulatory affairs, statistical analysis and report writing, marketresearch and development, the preparation and submission of Drug ApprovalApplications and all other activities [***]   [Confidential Treatment Required] or otherwiserequested or required by a Regulatory Authority as a condition or in support ofobtaining or maintaining a Regulatory Approval for an Antibody Product for aspecified Indication, but excluding Manufacturing.

 

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**DevelopmentPlan** means the plan for the Development of AntibodyProducts for Agreed Indications.  Anoutline for the Development Plan is attached as Schedule 3 and the DevelopmentPlan shall be adopted and subsequently updated and amended pursuant to Article4.7.  For clarity, the outline for theDevelopment Plan attached as Schedule 3 shall not constitute the DevelopmentPlan for the purposes of this Agreement.

 

**Distributor** means aperson or entity, other than a sublicensee, in a country that (a) purchases anAntibody Product from the Territorial Lead, its Affiliate or a permittedsublicensee for that country; (b) assumes responsibility from the TerritorialLead for all or a portion of the Promotion, marketing, sales and customerservice effort related to such Antibody Product in such country; and (c) sellsAntibody Product in such country.

 

**Dollar** means aUnited States dollar, and $ shall be interpreted accordingly.

 

**DrugApproval Application** means an application for any RegulatoryApproval required before commercial sale or marketing of a pharmaceutical orbiopharmaceutical product as a drug or to treat a particular Indication,including: (a) (i) a Biologics Licence Application (**BLA**) submitted to the FDA and (ii) any counterpart of a U.S.BLA in any other country in the Territory; and (b) all supplements andamendments that may be filed with respect to the foregoing.

 

**EMEA** means theEuropean Medicines Agency or a successor agency.

 

**EnforcementAction**means (a) the enforcement of a Patent Right orTrademark, (b) the defence of a validity or enforceability challenge to aPatent Right or Trademark, including the defence of an action for a declaratoryjudgment of, or counterclaim asserting, non-infringement, invalidity,unenforceability of a Patent Right or non-infringement, invalidity, unenforceability or dilution of a Trademark, asapplicable, or (c) a dispute pertaining to the inventorship of a Patent Rightor ownership of a Trademark.

 

**EU** means theeconomic, scientific and political organization of member states, as it may beexpanded from time to time.

 

**Europe** means thecountries comprising the EU and also includes Norway, Iceland, Lichtenstein andSwitzerland.

 

**FDA** means theUnited States Food and Drug Administration or a successor agency.

 

**FFDCA** means theUnited States Federal Food, Drug, and Cosmetic Act, as amended from time totime.

 

**Field** means the[***]   [ConfidentialTreatment Required].

 

**FirstCommercial Sale** means the first shipment of any AntibodyProduct sold to a Third Party by a Party or its Affiliates or their respectiveDistributors or sublicensees in a country in the Territory.  First Commercial Sale shall be determined ona country by country basis.

 

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**ForceMajeure** means any occurrence beyond the reasonable control ofa Party that prevents or substantially interferes with the performance by aParty of any of its obligations under this Agreement, including fires, floods,earthquakes, embargoes, shortages, epidemics, quarantines, war, acts of war(whether war be declared or not), acts of terrorism, insurrections, riots,civil commotion, acts of God or unforeseen acts, omissions or delays in actingby any governmental authority.  For clarity,any failure to perform by a sublicensee, Distributor or sub-contractor of aParty shall not be deemed a Force Majeure for such Party unless the reason forsuch failure is an occurrence beyond the reasonable control of suchsublicensee, Distributor or sub-contractor (as appropriate) that prevents orsubstantially interferes with the performance of the tasks that have beendelegated to such sublicensee, Distributor or sub-contractor by that Partypursuant to this Agreement.

 

**HSR Act** means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, asamended from time to time, and the rules and regulations promulgatedthereunder.

 

**HSR Filing** means any filing by UCB or ImClone with the United States FederalTrade Commission and the Antitrust Division of the United States Department ofJustice of a Notification and Report Form for Certain Mergers and Acquisitions(as that term is defined in the HSR Act) with respect to the matters set forthin this Agreement, together with all required documentary attachments thereto.

 

**GAAP** meansUnited States generally accepted accounting principles consistently applied.

 

**GCP** or **Good Clinical Practice** means thethen-current standards for clinical trials for pharmaceuticals as are requiredby the Regulatory Authorities in Europe, the United States and Japan and otherorganisations and governmental agencies in countries in which any AntibodyProduct is intended to be sold or tested, to the extent such standards are notless stringent than standards of good clinical practice in Europe, the UnitedStates and Japan, *provided* that aParty shall not be held to any standards of good clinical practice that aremore onerous than those standards required by Applicable Law and the RegulatoryAuthorities in the countries in which it is the Territorial Lead and, to theextent not included in such countries, Europe, the United States and Japan,unless such standards have been specifically identified and approved forimplementation by the JDT.

 

**GLP** means thethen-current standards for laboratory activities for pharmaceuticals, as arerequired by the Regulatory Authorities of Europe, the United States and Japan,including 21 C.F.R. part 58 and EC Directives 87/18/EEC, 88/320/EEC and1999/11/EC, in each case, as amended from time to time.

 

**GMP** or **cGMP** means the then-current standards forgood Manufacturing practices as are required by the Regulatory Authorities inEurope, the United States and Japan and other organisations and governmentalagencies in countries in which any Antibody Product is intended to beManufactured or sold, to the extent such standards are not less stringent thanstandards of good Manufacturing practice in Europe, the United States andJapan.

 

**ICH** means theInternational Conference on Harmonisation.

 

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**ImCloneCompany Marks** means the Trademarks Controlled by ImClone or itsAffiliates, whether on the Effective Date or during the Term, that aredesignated by ImClone pursuant to Article 6.12(b) for use on or in connectionwith the Development and Commercialisation of an Antibody Product under theAgreement.

 

**ImCloneCore Patent Rights** means those ImClone Patent Rights identifiedas such in Part 4 of Schedule 1.

 

**ImCloneIn-Licences** means the licences listed in Part 2 of Schedule 1, asmay be amended from time to time, each one an ImClone In-Licence.

 

**ImCloneKnow-How**means any and all Information and Materials that areControlled by ImClone or any of its Affiliates at any time [***]   [Confidential TreatmentRequired]; *provided*, *however*, that any Information andMaterials acquired by ImClone or any of its Affiliates after the EffectiveDate, whether by licence, merger, acquisition or otherwise, [***]   [Confidential TreatmentRequired].  ImClone Know-How excludes (i)any Information and Materials included in the Joint Know-How; (ii) anyInformation and Materials expressly excluded from this definition pursuant toArticle 10.8(b);  (iii) the ImClonePatent Rights; and (iv) Joint Patent Rights.

 

**ImClonePatent Rights** means any and all Patent Rights that are Controlledby ImClone or any of its Affiliates, in each case which if not licensed in thisAgreement would be infringed by Developing, Commercialising, making, havingmade, using, selling, having sold, offering to sell or resell, importing,exporting, distributing or otherwise transferring physical possession of orotherwise transferring title in or to an Antibody Product in the Field,including any Patent Rights which claim ImClone Know-How; *provided*, *however*,that any Patent Rights that are acquired by ImClone or any of its Affiliatesafter the Effective Date, whether by licence, merger, acquisition or otherwise,[***]   [ConfidentialTreatment Required].  ImClone PatentRights excludes the Joint Patent Rights and those Patent Rights expresslyexcluded from this definition pursuant to Article 10.8(b).  As of the Effective Date, ImClone PatentRights include those Patent Rights set out in Part 4 of Schedule 1.

 

**ImCloneTerritory** means the United States, Canada and Mexico, and eachof their respective territories and possessions.

 

**IND** means (a)(i) an Investigational New Drug Application (as defined in the FFDCA and theregulations promulgated thereunder, including 21 C.F.R. part 312) that isrequired to be filed with the FDA before beginning clinical testing of anAntibody Product in human subjects, or any successor application or procedure;and (ii) any counterpart of a U.S. Investigational New Drug Application in anyother country in the Territory; and (b) all supplements and amendments that maybe filed with respect to the foregoing.

 

**Indication**means aspecific line of therapy (i.e. first, second, third or other) for the cancersub-type(s) as set forth in a protocol of a particular Phase II Clinical Study,Phase III Clinical Study or Phase IV Clinical Study (or, where no cancersub-type is referenced in such protocol, a specific line of therapy for thecancer type set forth in such protocol).

 

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**Information** meanstangible or intangible know-how, trade secrets, inventions (that are conceivedand reduced to practice, constructively or actually), methods, knowledge,conclusions, skill, experience, test data and results (including chemical,biological, biochemical, pharmaceutical, pharmacological, toxicological andresearch, pre-clinical and other non-clinical data, clinical data, assay,control and manufacturing processes, test data and results), analytical andquality control methods and data, results or descriptions, software andalgorithms or other information (in each case, whether or not patentable)regarding technology, techniques, practices, products, protocols, procedures,business information or objectives.

 

**In-Licences** means theImClone In-Licences and the UCB In-Licences collectively.

 

**JointCommercialisation Team** or **JCT**means the team formed pursuant to Article 6.3.

 

**JointDevelopment Team** or **JDT**means the team formed pursuant to Article 4.6.

 

**JointKnow-How** means all Information conceived, developed,discovered, generated or otherwise made and all Materials characterised,conceived, developed, derived, generated or otherwise made, in either case (a)jointly by employees or consultants of UCB or its Affiliates or, to the extentUCB or its Affiliates has rights thereto, their respective sublicensees andDistributors, on the one hand, and ImClone or its Affiliates, or, to the extentImClone or its Affiliates has rights thereto, their respective sublicensees andDistributors, on the other hand (rather than independently by the employees orconsultants of one or the other Party or its Affiliates, sublicensees orDistributors) in the course of Development, Commercialisation or Manufacturingof an Antibody Product under or in connection with, and during the Term of,this Agreement or (b) [***]  [Confidential Treatment Required].

 

**JointManufacturing Team** or **JMT**means the committee formed pursuant to Article 7.1.

 

**JointPatent Committee** or **JPC**means the committee formed pursuant to Article 3.4.

 

**JointPatent Rights** means Patent Rights in any country within theTerritory which claim Joint Know-How.

 

**KDR** meanskinase domain receptor, also known in the literature as VEGFR2 or kinase insertdomain receptor.

 

**Knowledge** means,with respect to a Party, the good faith understanding of the facts and informationin the possession of an officer of such Party or any of its Affiliates, or anyin-house legal counsel of, or in-house patent agents employed by, such Party orany of its Affiliates, without any duty to conduct any additional investigationwith respect to such facts and information by reason of the execution of thisAgreement.  For purposes of thisdefinition, an “officer” shall mean any person in the position of vicepresident, senior vice president, president or chief executive officer, or anyperson having similar responsibilities, of a Party or any of its Affiliates.

 

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**Manufacturing** or **Manufacture** means all activities related tothe production, manufacture, processing, filling, finishing, packaging,labelling, shipping, and storage of Antibody Products, including processdevelopment, process qualification and process validation, manufacturingscale-up, pre-clinical, clinical and commercial manufacture and analyticaldevelopment, product characterisation, quality assurance and quality control.

 

**Materials** meansbiological and chemical materials, including Antibodies (other than AntibodyProducts), screens, animal models, cell lines, cells, vectors, nucleic acids,and reagents, and any progeny or derivatives thereof.

 

**Non-RemainingParty**means, on termination of this Agreement, the Partydesignated as the Non-Remaining Party under Article 12.2, 12.3(a), 12.4(d),12.5(b) or 12.6 (as appropriate).

 

**Party** means UCBor ImClone; **Parties** means UCB andImClone.

 

**PatentRights** means, in any country, all: (a) existing issued,unexpired patents (with the term patent being deemed to encompass an inventor’scertificate, utility model, petty patent and design patent), including anyreissue, re-examination, renewal or extension (including any supplementaryprotection certificate) of any such patent, and any confirmation patent orregistration patent or patent of addition based on any such patent, in suchcountry; (b) existing patent applications and patent applications filed afterthe date of this Agreement, including any request for continued examination(RCE), continuations, continuations-in-part, divisionals, provisionals,converted provisional, continued prosecution application, or any substituteapplications, any patent issued with respect to any such patent applications,any reissue, re-examination, renewal or extension (including any supplementaryprotection certificate) of any such patent and any confirmation patent orregistration patent or patent of addition based on any such patent in suchcountry; and (c) all foreign counterparts of any of the foregoing.

 

**Post-ApprovalStudy** means any human clinical study, or other test orstudy, other than a Clinical Study, with respect to an Antibody Product for anAgreed Indication or an Independent Indication that (a) is conducted solely insupport of pricing or reimbursement for a product in a country or (b) is notrequired to obtain or maintain Regulatory Approval for such Antibody Productfor such Agreed Indication or Independent Indication and is conducted (i)within the scope of the Product Labelling for such Antibody Product or (ii)outside the scope of such Product Labelling in support of a Compendia Listing(for clarity, any human clinical study that is intended to expand the ProductLabelling for an Antibody Product (except as provided in paragraph (ii) above)shall be a Clinical Study and shall be governed by the procedures set forth inArticle 4.9 with respect to new Indications). Subject to the foregoing, Post-Approval Studies may includeepidemiological studies, modeling and pharmacoeconomic studies, post-marketingsurveillance studies, investigator sponsored studies, and health economicsstudies.

 

[***]  [Confidential Treatment Required]

 

**ProductLabelling** means, with respect to an Antibody Product, for anycountry of the Territory (a) the Regulatory Authority-approved full prescribinginformation for

 

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such Antibody Product for that country,including any required patient information; and (b) all labels and otherwritten, printed or graphic matter upon a container, wrapper or any packageinsert utilised with or for such Antibody Product.

 

**ProductTrademark** means any Trademark that is identified by the Partiesand approved by the Collaboration Committee pursuant to Article 3.2(d) for usein Commercialising the Antibody Products in the Territory, but not includingany Corporate Marks.

 

**Promote,Promotion, Promoting** or **Promotional**means, with respect to an Antibody Product, those activities and obligationsother than Detailing undertaken by a Party, its Affiliates, sublicensees orDistributors to encourage sales of such Antibody Product, including journaladvertising, direct mail programmes, direct-to-consumer advertising, Internetadvertising, broadcast advertising, distributing sales reminders (e.g., scratchpads, pens and other such items), convention exhibits, and other forms ofadvertising and promotion.

 

**PromotionalMaterials** means all sales representative training materialswith respect to an Antibody Product and all written, printed, graphic,electronic, audio or video matter, including journal advertisements, salesvisual aids, direct mail, direct-to-consumer advertising, Internet postings,broadcast advertisements, and sales reminder aids (e.g., scratch pads, pens andother such items) intended for use or used by a Party, its Affiliates,sublicensees and Distributors in connection with any Promotion or Detailing ofan Antibody Product, except Product Labelling.

 

**RegulatoryApproval** means any and all approvals (including any applicablesupplements, amendments, pre- and post-approvals, governmental price andreimbursement approvals and approvals of applications for regulatoryexclusivity), licences, registrations, or authorisations of any federal,national, multinational, international, state, provincial or local regulatoryagency, department, bureau, commission, council or other governmental entitynecessary for the Manufacture, distribution or other transfer of possession,use, holding, storage, import, export, transport, Promotion, marketing or saleof an Antibody Product in a country or jurisdiction in the Territory.  For clarity, a Compendia Listing shall not bedeemed to be a Regulatory Approval.

 

**Regulatory Authority** means anygovernmental or regulatory authority involved in granting Regulatory Approvals.

 

**RemainingParty** means, on termination of this Agreement, the Partydesignated as the Remaining Party under Article 12.1, 12.2, 12.3, 12.4(d),12.5(b) or 12.6 (as appropriate).

 

**Royalties**means anyor all of (i) the ImClone Royalties; (ii) the royalties payable by either Partypursuant to Article 8.2(b) on the sale of Antibody Products for IndependentIndications; and (iii) [***]  [Confidential Treatment Required].

 

**Royalty-BearingPatent Rights** means the ImClone Core Patent Rights identified as“Royalty-Bearing” in Part 4 of Schedule 1.

 

**Term** means theterm of this Agreement as set out in Article 12.1.

 

13

----

 

[***]  [Confidential Treatment Required]

 

**TerritorialLead** means ImClone in the ImClone Territory; and UCB inthe UCB Territory.

 

**Territory** means allthe countries of the world.

 

**Third Party** means anyperson, partnership, joint venture, corporation, trust, estate, unincorporatedorganisation, government or any department or agency of any of them, or anyother entity other than a Party or any of its Affiliates.

 

**Trademark** means anycorporate name, trade name, service mark, service name, house mark, trade dress,trade mark or logo, in each case whether or not registered, and allapplications for, and registrations of, and all renewals, extensions ormodifications to, and any goodwill associated with, any of them in theTerritory.

 

**UCB CorePatent Rights** means those UCB Patent Rights identified as such inPart 3 of Schedule 1.

 

**UCB CompanyMarks** means the Trademarks Controlled by UCB or itsAffiliates, whether on the Effective Date or during the Term, that aredesignated by UCB pursuant to Article 6.12(b) for use in connection with theDevelopment and Commercialisation of an Antibody Product under the Agreement.

 

**UCBIn-Licences** means the licences listed in Part 1 of Schedule 1, asmay be amended from time to time, each one a UCB In-Licence.

 

**UCB Know-How**means any and all Information and Materials that are Controlled by UCBor any of its Affiliates at any time during the Term that [***]   [Confidential TreatmentRequired]; *provided*, *however*, that any Information andMaterials acquired by UCB or any of its Affiliates after the Effective Date,whether by licence, merger, acquisition or otherwise, [***]   [Confidential TreatmentRequired].  UCB Know-How excludes(i) any Information and Materials included in the Joint Know-How; (ii) anyInformation and Materials expressly excluded from this definition pursuant toArticle 10.8(b); (iii) the UCB Patent Rights; and (iv) Joint Patent Rights.

 

**UCB PatentRights** means any and all Patent Rights that are Controlledby UCB or any of its Affiliates, in each case which if not licensed in thisAgreement would be infringed by Developing, Commercialising, making, havingmade, using, selling, having sold, offering to sell or resell, importing,exporting, distributing or otherwise transferring physical possession of orotherwise transferring title in or to an Antibody Product in the Field,including any Patent Rights which claim UCB Know-How; *provided, however*, that any Patent Rightsthat are acquired by UCB or any of its Affiliates after the Effective Date,whether by licence, merger, acquisition or otherwise, [***]   [Confidential TreatmentRequired].  UCB Patent Rights excludes the Joint Patent Rights and thosePatent Rights expressly excluded from this definition pursuant to Article10.8(b).  As of the Effective Date, UCB Patent Rights include those PatentRights set out in Part 3 of Schedule 1.

 

**UCBTerritory** means the Territory excluding the ImClone Territory.

 

14

----

 

**Valid Claim** means,with respect to a particular country, any claim of a [***]   [Confidential TreatmentRequired] Patent Right in such country that (i) has not been held permanentlyrevoked, unenforceable or invalid by a decision of a court or othergovernmental agency of competent jurisdiction, which decision is unappealable orunappealed within the time allowed for appeal, and (ii) has not been abandoned,disclaimed, denied or admitted to be invalid or unenforceable through reissue,re-examination, disclaimer or otherwise.

 

## **1.2****                              **Eachof the following definitions is found in this Agreement as indicated.

 
| **Defined Terms**               | ** ** | **Page/Article/Schedule**                   | ** ** |
|---------------------------------|------------|---------------------------------------------|------------|
| ** **                      | ** ** | ** **                                  | ** ** |
| Acquired Party                  |       | Article 17.14                               |       |
|                            |       |                                        |       |
| Acquiring Party                 |       | Article 10.8(b)                             |       |
|                            |       |                                        |       |
| Additional Manufacturing Amount |       | Article 7.13(b)                             |       |
|                            |       |                                        |       |
| Agreement                       |       | Pg. 3, first paragraph                      |       |
|                            |       |                                        |       |
| Antibody Product Specifications |       | Article 7.2(g)                              |       |
|                            |       |                                        |       |
| Antibody Product Standards      |       | Article 7.8(d)                              |       |
|                            |       |                                        |       |
| BLA                             |       | Article 1.1, def. Drug Approval Application |       |
|                            |       |                                        |       |
| CEDR                            |       | Article 15.4                                |       |
|                            |       |                                        |       |
| CEO Period                      |       | Article 15.3                                |       |
|                            |       |                                        |       |
| Challenging Party               |       | Article 12.6                                |       |
|                            |       |                                        |       |
| COGM                            |       | Schedule 2                                  |       |
|                            |       |                                        |       |
| Commercialisation Budget        |       | Article 6.8(a)                              |       |
|                            |       |                                        |       |
| Commercialisation Team Leader   |       | Article 6.3(a)                              |       |
|                            |       |                                        |       |
| Competing Activity              |       | Article 12.3(a)                             |       |
|                            |       |                                        |       |
| Continuing Indications          |       | Article 12.8(a)(i)                          |       |
|                            |       |                                        |       |
| Continuing Party                |       | Article 8.1                                 |       |
|                            |       |                                        |       |
| Controlling Party               |       | Article 10.4(c)                             |       |
|                            |       |                                        |       |
| Conversion                      |       | Article 8.9(a)                              |       |
|                            |       |                                        |       |
| Convert                         |       | Article 8.9(a)                              |       |
|                            |       |                                        |       |
| Converted Agreed Indication     |       | Article 8.9(f)                              |       |

 

15

----

 
| Country Plan            |   | Article 6.6(a)                  |   |
|-------------------------|--------|---------------------------------|--------|
|                    |   |                            |   |
| CP Conversion           |   | Article 16.5(a)                 |   |
|                    |   |                            |   |
| CP Conversion Notice    |   | Article 16.5(a)                 |   |
|                    |   |                            |   |
| Cure Period             |   | Article 12.4(a)                 |   |
|                    |   |                            |   |
| Default                 |   | Article 12.4(a)                 |   |
|                    |   |                            |   |
| Default Conversion      |   | Article 8.9(a)(ii)              |   |
|                    |   |                            |   |
| Defaulting Party        |   | Article 12.4(a)                 |   |
|                    |   |                            |   |
| Development Budget      |   | Article 4.5(a)                  |   |
|                    |   |                            |   |
| Development Costs       |   | Schedule 2                      |   |
|                    |   |                            |   |
| Development Team Leader |   | Article 4.6(a)                  |   |
|                    |   |                            |   |
| Dispute                 |   | Article 15.1                    |   |
|                    |   |                            |   |
| Distribution Costs      |   | Schedule 2                      |   |
|                    |   |                            |   |
| Effective Date          |   | Pg. 3, first paragraph          |   |
|                    |   |                            |   |
| Excluded Party          |   | Article 12.3(a)                 |   |
|                    |   |                            |   |
| Filing Party            |   | Article 5.1(b)                  |   |
|                    |   |                            |   |
| First Contract Year     |   | Article 1.1, def. Contract Year |   |
|                    |   |                            |   |
| FTE                     |   | Schedule 2                      |   |
|                    |   |                            |   |
| FTE Cost                |   | Schedule 2                      |   |
|                    |   |                            |   |
| Gross Receipts          |   | Schedule 2                      |   |
|                    |   |                            |   |
| ImClone                 |   | Pg. 3, paragraph (2)            |   |
|                    |   |                            |   |
| ImClone Royalties       |   | Article 6.15(b)                 |   |
|                    |   |                            |   |
| Indemnitees             |   | Article 14.1(a)                 |   |
|                    |   |                            |   |
| Independent Indication  |   | Article 8.1                     |   |
|                    |   |                            |   |
| Information Request     |   | Article 8.9(a)(i)               |   |
|                    |   |                            |   |
| Initial Payment Period  |   | Article 8.2(a)                  |   |
|                    |   |                            |   |
| Insolvency Event        |   | Article 12.5(b)(iii)            |   |
|                    |   |                            |   |
| Joint Activities        |   | Article 6.4(a)(ii)              |   |

 

16

----

 
| LCIA                            |   | Article 15.3    |   |
|---------------------------------|--------|-----------------|--------|
|                            |   |            |   |
| Losses                          |   | Article 14.1(a) |   |
|                            |   |            |   |
| Managing Party                  |   | Article 10.5(e) |   |
|                            |   |            |   |
| Manufacturer                    |   | Article 7.2(c)  |   |
|                            |   |            |   |
| Manufacturing Agreement         |   | Article 7.2(d)  |   |
|                            |   |            |   |
| Manufacturing Coordinator       |   | Article 7.2(b)  |   |
|                            |   |            |   |
| Manufacturing Know How          |   | Article 7.8(b)  |   |
|                            |   |            |   |
| Manufacturing Patents           |   | Article 7.8(b)  |   |
|                            |   |            |   |
| Manufacturing Plan              |   | Article 7.2(a)  |   |
|                            |   |            |   |
| Manufacturing Team Leader       |   | Article 7.1     |   |
|                            |   |            |   |
| Marketing Costs                 |   | Schedule 2      |   |
|                            |   |            |   |
| Markings                        |   | Article 6.12(b) |   |
|                            |   |            |   |
| Merging Party                   |   | Articles 16.4   |   |
|                            |   |            |   |
| Net Receipts                    |   | Schedule 2      |   |
|                            |   |            |   |
| Net Sales                       |   | Schedule 2      |   |
|                            |   |            |   |
| Non-Acquired Party              |   | Article 17.14   |   |
|                            |   |            |   |
| Non-Challenging Party           |   | Article 12.6    |   |
|                            |   |            |   |
| Non-Continuing Party            |   | Article 8.1     |   |
|                            |   |            |   |
| Non-Defaulting Party            |   | Article 12.4(a) |   |
|                            |   |            |   |
| Non-Remaining Party Indemnitees |   | Article 14.1(b) |   |
|                            |   |            |   |
| Notice of Default               |   | Article 12.4(a) |   |
|                            |   |            |   |
| Operating Profits and Losses    |   | Schedule 2      |   |
|                            |   |            |   |
| Operating Statement             |   | Schedule 2      |   |
|                            |   |            |   |
| Option Exercise Notice          |   | Article 8.9(a)  |   |
|                            |   |            |   |
| Opt-Out Date                    |   | Article 16.2    |   |
|                            |   |            |   |
| Other Out of Pocket Costs       |   | Schedule 2      |   |
|                            |   |            |   |
| Patent Costs                    |   | Schedule 2      |   |

 

17

----

 
| Phase I Clinical Study                          |   | Article 1.1, def. Clinical Study                |   |
|-------------------------------------------------|--------|-------------------------------------------------|--------|
|                                            |   |                                            |   |
| Phase II Clinical Study                         |   | Article 1.1, def. Clinical Study                |   |
|                                            |   |                                            |   |
| Phase III Clinical Study                        |   | Article 1.1, def. Clinical Study                |   |
|                                            |   |                                            |   |
| Phase IV Clinical Study                         |   | Article 1.1, def. Clinical Study                |   |
|                                            |   |                                            |   |
| Post-Approval Study Expenses                    |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Pre-Marketing Costs                             |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Product Trademark Owner                         |   | Article 10.1(b)                                 |   |
|                                            |   |                                            |   |
| Recall                                          |   | Article 5.5(a)                                  |   |
|                                            |   |                                            |   |
| Reimbursable Costs                              |   | Article 8.9(b)                                  |   |
|                                            |   |                                            |   |
| Reimbursable Commercial Costs                   |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Reimbursement Amount                            |   | Article 8.9(c)                                  |   |
|                                            |   |                                            |   |
| Relevant Net Sales                              |   | Article 8.2(b)                                  |   |
|                                            |   |                                            |   |
| Relevant Supply                                 |   | Article 7.13(a)                                 |   |
|                                            |   |                                            |   |
| Representatives                                 |   | Article 14.1(b)(i)                              |   |
|                                            |   |                                            |   |
| Responsible Party                               |   | Article 10.7(b)(v)                              |   |
|                                            |   |                                            |   |
| Royalty Term                                    |   | Article 6.15(c)                                 |   |
|                                            |   |                                            |   |
| Sales Costs                                     |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Sales Returns and Allowances                    |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| SOPs                                            |   | Article 5.5(a)                                  |   |
|                                            |   |                                            |   |
| Terminating Party                               |   | Article 12.2                                    |   |
|                                            |   |                                            |   |
| [***]    [Confidential Treatment Required] |   | [***]    [Confidential Treatment Required] |   |
|                                            |   |                                            |   |
| Third Party Claims                              |   | Article 14.1(a)                                 |   |
|                                            |   |                                            |   |
| Third Party Licence Fees                        |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Transfer Price                                  |   | Schedule 2                                      |   |
|                                            |   |                                            |   |
| Transition Period                               |   | Article 12.8(a)(i)                              |   |
|                                            |   |                                            |   |
| Transition Plan                                 |   | Article 12.8(a)(i)                              |   |
|                                            |   |                                            |   |
| UCB                                             |   | Pg. 3, paragraph (1)                            |   |

 

18

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# **2.****                                     ****SCOPE OF COLLABORATION**

# ** **

## **2.1****                              ****Collaboration Goals**

##  

### (a)                                  Pursuant andsubject to the terms of this Agreement:

###  

#### (i)                                     each Party shalluse [***]  [Confidential Treatment Required] to carry out the Developmentactivities assigned to it pursuant to, and in accordance with, the DevelopmentPlan, as amended from time to time;

####  

#### (ii)                                  ImCloneshall use [***]  [Confidential Treatment Required] to obtain allnecessary Regulatory Approvals as soon as reasonably practicable in [***]   [Confidential TreatmentRequired] for each Antibody Product for each Agreed Indication;

####  

#### (iii)                               UCBshall use [***]  [Confidential Treatment Required] to obtain allnecessary Regulatory Approvals as soon as reasonably practicable in [***]   [Confidential TreatmentRequired], for each Antibody Product for each AgreedIndication;

####  

#### (iv)                              eachParty shall use [***]  [Confidential Treatment Required] to Commercialiseeach Antibody Product for each Agreed Indication for which Regulatory Approvalhas been obtained; and

####  

#### (v)                                 the Parties shallshare Operating Profits and Losses of Antibody Products in the manner set forthin Articles 2.3(b), 8.9, 12.10 and 16.5(c) and UCB shall pay ImClone theImClone Royalties as set forth in Article 6.15.

####  

### (b)                                 Subject to Article4.7(f), the Parties acknowledge that the sole initial focus of the Developmentshall be of CDP-791 in the Field as set forth in the outline for theDevelopment Plan set forth in Schedule 3. Either Party may, from time to time, notify the other Party in writingthat it wishes to extend the focus of the Development to include otherAntibodies in the Field, *provided*that there shall be no amendment to the focus of the Development unless anduntil the other Party, in its sole discretion, consents in writing to suchextension of the focus.

###  

### (c)                                  Each Party shall co-operatewith and provide reasonable support to the other Party in performing itsactivities with respect to the Development and Commercialisation workcontemplated under this Agreement.

###  

### (d)                                 Notwithstandinganything in this Agreement to the contrary, but without expanding each Party’sdiligence obligation under Article 2.1(a), neither Party (or any of itsAffiliates) shall take any action or, with respect to the implementation of theresponsibilities assigned to it under the Development Plan, CommercialisationPlan, Manufacturing Plan or otherwise under this Agreement, fail to take anyaction with respect to the Development,

 

19

----

 

### Manufacturing or Commercialisation of an Antibody Product, whether foran Agreed Indication or an Independent Indication, that it knows, or shouldknow, is reasonably likely to have a material adverse affect on theDevelopment, Manufacture or Commercialisation of an Antibody Product in [***]   [Confidential TreatmentRequired], unless it has first consulted with, and obtainedprior written consent to take or refrain from taking such action from, the JDT(where the adverse affect would be on Development), the JMT (where the adverseeffect would be on Manufacturing), and/or the JCT (where the adverse affectwould be on Commercialisation) [***]   [Confidential Treatment Required], *provided* that any Dispute as to anyproposed act or omission shall be resolved in accordance with Article 15 [***]   [Confidential TreatmentRequired].

###  

## **2.2****                              ****Exclusive Collaboration**

##  

Except as provided in Article 16.4, the Partiesagree that for the duration of this Agreement [***]   [Confidential TreatmentRequired] they and their Affiliates will Develop, Commercialise and ManufactureAntibody Products in the Field in the Territory exclusively within the scope ofthis collaboration and subject to the terms of this Agreement and, other thanas explicitly permitted under this Agreement (including with respect topermitted sublicensees or Distributors), will not undertake or enable any ThirdParty to Develop, Commercialise or Manufacture any Antibody Products in theField without the other Party’s prior written consent.

 

## **2.3****                              ****Financials and Audit Rights**

##  

### (a)                                  UCB shall payImClone the royalties as described in Article 6.15.

###  

### (b)                                 Subject to Articles8.9, 12.10 and 16.5, during the Term the Parties shall share Operating Profitsand Losses as follows:

###  

#### (i)                                     except as providedin Article 2.3(b)(ii), for each Antibody Product, each Party is entitled to andresponsible for fifty per cent. (50%) of Operating Profits and Losses; and

####  

#### (ii)                                  for anAntibody Product for an Independent Indication (A) if ImClone is the ContinuingParty for such Independent Indication, then, except as otherwise expresslyprovided in this Agreement, [***]   [Confidential Treatment Required]entitled to and responsible for [***]   [Confidential Treatment Required] ofOperating Profits and Losses for such Antibody Product for such IndependentIndication in the [***]  [Confidential Treatment Required], and in accordancewith Articles 4.7(d), 8.1 and 8.2, [***]   [Confidential Treatment Required] forsuch Antibody Product for such Independent Indication in the [***]   [Confidential TreatmentRequired], and (B) if UCB is the Continuing Party for suchIndependent Indication, then, except as otherwise expressly provided in thisAgreement, [***]  [Confidential Treatment Required] is entitled to andresponsible for [***]  [Confidential Treatment Required] of OperatingProfits and Losses for such Antibody Product for such Independent Indication inthe [***]  [Confidential Treatment Required], and in accordance with

####  

20

----

 

#### Articles 4.7(d), 8.1 and 8.2, [***]   [Confidential Treatment Required] forsuch Antibody Product for such Independent Indication in the [***]   [Confidential TreatmentRequired].

####  

### (c)                                  Within [***]   [Confidential TreatmentRequired] from the end of each calendar month, each Party shallsubmit to the other Party a written report setting out, on anactivity-by-activity basis, the Development Costs it has incurred in thatcalendar month (or, where such information is not available, a reasonableestimate of such Development Costs) as against the amount budgeted for thatactivity in the Development Budget.

###  

### (d)                                 From the date ofthe First Commercial Sale of an Antibody Product each Party during the Term andthereafter the Remaining Party shall within [***]   [Confidential Treatment Required] afterthe end of each Calendar Quarter deliver to the other Party a detailed reportshowing:

###  

#### (i)                                     the Net Sales andthe units of each Antibody Product sold by such first Party or the RemainingParty, its Affiliates and their respective Distributors and sublicensees in thecountries for which such Party is the Territorial Lead during the applicableCalendar Quarter on a country by country basis;

####  

#### (ii)                                  duringthe Term if such first Party is a Continuing Party, the Net Sales and units ofeach Antibody Product sold by such first Party, its Affiliates and theirrespective Distributors and sublicensees in a country for which such Party isthe Territorial Lead for use in an Independent Indication for which such Partyis the Continuing Party during the applicable Calendar Quarter on a country bycountry basis using the allocation methodology agreed to by the Partiespursuant to Article 8.3 together with such support for such sales as the otherParty may reasonably request; and

####  

#### (iii)                               theamount of Royalties payable and if applicable the breakdown of the calculationof the Net Sales under paragraphs (i) and (ii) above during the applicableCalendar Quarter.

####  

### (e)                                  On receipt of eachreport for a Calendar Quarter delivered by one Party pursuant to Article2.3(d), the other Party will issue an invoice for the Royalties payable asspecified in Article 2.3(d)(iii). Royalties shall be payable, with respect to each Calendar Quarter,within [***]  [Confidential Treatment Required] after receipt of suchinvoice.  Royalties shall be calculatedin accordance with GAAP and with the terms of this Article 2.3 and asapplicable Article 6.15, Article 8.2 and Article 12.9(a) or Article 0.

###  

### (f)                                    Except as otherwiseprovided in this Agreement, other payment, accounting and financial rights andobligations of the Parties are set forth in Schedule 2.  Subject to Article 2.3(l), all Disputesrelated to payment, accounting and financial rights and obligations of theParties shall be referred to the Collaboration Committee, and if theCollaboration Committee is unable to resolve such Dispute, the Dispute shall bedecided under the provisions of Article 15 [***]   [Confidential Treatment Required].

###  

21

----

 

### (g)                                 All amounts duefrom one Party to the other Party under this Agreement shall be paid in Dollarsby wire transfer in immediately available funds to an account designated by thereceiving Party.  Any payments orportions due hereunder that are not paid on the date such payments are dueunder this Agreement shall bear interest at a rate equal to the lesser of LIBOR[***]  [Confidential Treatment Required], and the maximum ratepermitted by law, calculated on the number of days such payment is delinquent,compounded monthly.  For the purpose ofthis Article 2.3(g) LIBOR means the British Bankers’ Association InterestSettlement Rate for the relevant currency and period as displayed on theappropriate page of the Telerate screen. If the Telerate screen is replaced or the service ceases to beavailable, the Parties shall agree a reasonable alternative page or servicedisplaying the appropriate rate.

###  

### (h)                                 If any currencyconversion shall be required in connection with any payment due under thisAgreement, such conversion shall be made by using the exchange rate for thepurchase of Dollars as published in The Wall Street Journal, Eastern Edition,on the last Business Day of the Calendar Quarter or the calendar month (as thecase may be) to which such payments relate.

###  

### (i)                                     The Parties shallmaintain (and shall ensure that their Affiliates and respective sublicenseesand Distributors maintain) complete and accurate books, records, accounts andsupporting data that fairly and accurately reflect their respective Net Sales,Gross Receipts, Sales Returns and Allowances, the Transfer Price, DistributionCosts, Development Costs, Patent Costs, Pre-Marketing Expenses, MarketingCosts, Sales Costs, Post-Approval Study Expenses and Other Out of Pocket Costsand COGM in sufficient detail to confirm the accuracy of any payments requiredunder this Agreement and in accordance with GAAP, which books, records,accounts and supporting data shall be retained by such Party until the later of(i) [***]  [Confidential Treatment Required] after the end of the periodto which such books, records, accounts and supporting data pertain; and (ii)the expiration of the applicable tax statute of limitations (or any extensionsthereof), or for such longer period as may be required by Applicable Law.

###  

### (j)                                     Each Party shallhave the right for a period of [***]   [Confidential Treatment Required] afterreceiving or making any payment under this Agreement from or to the other Partyto have an independent certified public accounting firm of internationallyrecognised standing, reasonably acceptable to such other Party, have accessduring normal business hours, and upon reasonable prior written notice, to suchof the books, records, accounts and supporting data of such other Party (andits Affiliates and their respective sublicensees and Distributors) as may bereasonably necessary to verify the accuracy of that payment.  The auditing Party shall not have the rightto conduct more than [***]  [Confidential Treatment Required] such audit in any [***]   [Confidential TreatmentRequired] period during the Term, unless an earlier audit insuch period revealed a material inaccuracy in the payment or such audit isrequired by Applicable Law.  The accountingfirm shall disclose in writing to each Party whether such payments are corrector incorrect and the specific details concerning any discrepancies.  The auditing Party shall bear

 

22

----

 

### the cost of such audit unless the audit reveals a variance in the amountthat should have been paid of more than [***] [Confidential Treatment Required]for the period from the Effective Date or the date of the previous audit (whicheveris later) until the date of the audit, in which case the audited Party shallbear the cost of the audit.  The resultsof such audit shall be final, absent manifest error.  If, based on the results of any such audit, additionalpayments or refunds are owed by a Party under this Agreement, that Party shallmake such additional payments or refunds, with interest from the dateoriginally due, as applicable, [***] [Confidential Treatment Required] afterthe date on which such accounting firm’s written report is delivered to theParties.

###  

### (k)                                  No Royalties shallbe taken into account in the calculation of Operating Profits or Losses.

###  

### (l)                                     Any Disputepertaining to whether any Royalties, other than the [***] [ConfidentialTreatment Required], are payable in respect of any sale of an Antibody Productshall be determined by the JCT.  If theJCT cannot resolve any such Dispute it shall be referred to the CollaborationCommittee for resolution and if the Collaboration Committee is unable toresolve such Dispute, the Dispute shall be decided under the provisions ofArticle 15 [***] [Confidential Treatment Required].

###  

## **2.4****                              ****Employee Obligations**

##  

Prior to beginning work relating to any aspectof the subject matter of this Agreement or being given access to UCB Know-Howor ImClone Know-How, each employee, consultant or agent of ImClone and UCB,respectively, and their respective Affiliates, sublicensees and Distributors,shall be bound by an agreement pursuant to which:

 

### (a)                                  each such person(other than administrative or non-technical personnel) shall (but in the caseof a Party’s own Information and Materials, only to the extent such Party’semployees, consultants or agents are conducting activities pursuant to thisAgreement) be obliged to:

###  

#### (i)                                     follow such Party’spolicies and procedures regarding reporting any invention, discovery,process, software program, Information or Material characterised, conceived,developed, derived, discovered, generated, identified or otherwise made by suchperson in the course of his or her employment or retainer with such Party, includingany intellectual property or proprietary right thereto, that falls within JointKnow-How, UCB Know-How or ImClone Know-How;

####  

#### (ii)                                  assignto such Party all of his or her right, title and interest in and to any suchinvention, discovery, process, software program, Information or Materialcharacterised, conceived, developed, derived, discovered, generated, identifiedor otherwise made by such person in the course of his or her employment orretainer with such Party, including any intellectual property or proprietaryright thereto;

####  

#### (iii)                               co-operatein the preparation, filing, prosecution, maintenance, defence and enforcementof any Patent Rights claiming the same; and

####  

23

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#### (iv)                              performall acts and sign, execute, acknowledge and deliver any and all papers,documents and instruments required for effecting the obligations and purposesof that agreement; and

####  

### (b)                                 each person shallbe bound by obligations of confidentiality and non-use consistent with theterms of this Agreement.  It isunderstood and agreed that any such agreement need not be specific to thisAgreement.

###  

## **2.5****                              ****1121B**

##  

Each Party acknowledges and agrees that anyactivities conducted by or on behalf of ImClone or its Affiliates with respectto 1121B prior to (and including) the date (if any) ImClone provides UCB withits written confirmation and undertaking pursuant to Article 16.3, do notconstitute activities conducted under or in connection with thisAgreement.  Notwithstanding any otherprovision in this Agreement, ImClone has no obligation to transfer anyMaterials relating to 1121B prior to that date and thereafter any transfer ofsuch Materials shall be subject to Article 4.10.

 

# **3.****                                     ****COLLABORATION MANAGEMENT**

# ** **

## **3.1****                              ****Establishment of the Collaboration Committee**

##  

Within [***] [Confidential Treatment Required]after the Effective Date, the Parties shall form a CollaborationCommittee.  The Collaboration Committeeshall be composed of an equal number of representatives of each Party (up to amaximum of [***] [Confidential Treatment Required] representatives per Party)appointed (and may be replaced at any time) by such Party on written notice tothe other Party.  At least [***][Confidential Treatment Required] such representative from each of UCB andImClone, respectively, shall, prior to establishment of the JCT, be a VicePresident and, after establishment of the JCT, be a Senior or Executive VicePresident or equivalent of their respective company, and all suchrepresentatives shall be individuals of suitable authority and seniority withsignificant experience or expertise in biopharmaceutical drug development,commercialisation or marketing.  Anymember of the Collaboration Committee may designate a substitute of equalexperience and seniority to attend and perform the functions of that member atany meeting of the Collaboration Committee. Each Party may invite (at its discretion and with the consent of theother Party) additional employees, or consultants to attend CollaborationCommittee meetings.

 

## **3.2****                              ****Collaboration Committee Responsibilities**

##  

The Collaboration Committee shall have thegeneral responsibility of overseeing the Development of Antibody Products forAgreed Indications according to the Development Plan, overseeing theCommercialisation of Antibody Products in the Field in the Territory accordingto the Commercialisation Plan, establishing and managing the annual DevelopmentBudget and Commercialisation Budget, overseeing the Manufacturing of theAntibody Products in accordance with the Manufacturing Plan, coordinating aregular flow of information between the Parties, managing the relationshipbetween the Parties, and more generally, making all necessary strategicdecisions relating to the collaboration under this Agreement.  In addition, the Collaboration Committeeshall, subject to the terms of this Agreement:

 

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### (a)                                  approve the initialDevelopment Plan, Development Budget, Commercialisation Plan, CommercialisationBudget and Manufacturing Plan and approve any updates and amendments thereto;

###  

### (b)                                 determine from timeto time whether or not the Parties should continue Development, Manufacturingand Commercialisation of an Antibody Product for an Agreed Indication;

###  

### (c)                                  serve as the firstforum for attempted settlement of disputes or disagreements arising in otherCommittees or any other Disputes as set forth in Article 15.1;

###  

### (d)                                 approve all ProductTrademarks and generic names proposed by the JCT for use with respect to anAntibody Product in consultation with the JPC;

###  

### (e)                                  approve allprotocols, and changes to protocols, for Clinical Studies for all AntibodyProducts for Agreed Indications proposed by the JDT;

###  

### (f)                                    review allprotocols, and changes to protocols, for Clinical Studies for all AntibodyProducts for Independent Indications referred by the JDT;

###  

### (g)                                 review allprotocols for Post-Approval Studies in support of Compendia Listings referredby the JDT;

###  

### (h)                                 approve allrecommendations of the JCT with respect to the product positioning, pricing andreimbursement issues for all Antibody Products;

###  

### (i)                                     approve allrecommendations of the JDT with respect to the packaging, labelling andlanguage to be included in the Product Labelling of all Antibody Products; and

###  

### (j)                                     perform such otherfunctions as are allocated to it under the other provisions of this Agreementor as appropriate to further the purposes of this Agreement as determined bythe Parties.

###  

## **3.3****                              ****Decision Making; Administrative Matters**

##  

### (a)                                  **CollaborationCommittee Decision-Making**

###  

All decisions of the Collaboration Committeeshall be made by the [***] [Confidential Treatment Required], with therepresentatives of each Party who are members of the CollaborationCommittee[***] [Confidential Treatment Required] in any matter requiring the approvalof the Collaboration Committee.  TheParties agree that all decisions by the Collaboration Committee regarding theDevelopment, Commercialisation or Manufacture of an Antibody Product shall bemade in the interests of maximising the long-term value of the Antibody Producton a global basis.  If the CollaborationCommittee is unable to resolve a dispute regarding any issue, the matter shallbe resolved pursuant to the dispute resolution process set forth in Article 15.

 

25

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### (b)                                 **ProceduralRules**

###  

The Collaboration Committee shall establish itsown procedural rules for its operation consistent with the terms of thisArticle 3.  A chairperson for theCollaboration Committee shall be appointed from among its members.  The chairperson shall be appointed on anannual basis and shall alternate each Contract Year between a UCBrepresentative and an ImClone representative, UCB being responsible fordesignating the chairperson for the first Contract Year.  The chairperson shall be responsible forcalling meetings of the Collaboration Committee in accordance with Article3.3(c) and for leading the meetings.  Onemember representing the Party that did not appoint the chairperson shall serveas secretary of that meeting.  Thesecretary of the meeting shall prepare and distribute ([***] [ConfidentialTreatment Required] following each meeting) to all members of the CollaborationCommittee the minutes of the meeting. Such minutes shall provide a description in reasonable detail of thediscussions held at the meeting and a list of any actions, decisions ordeterminations approved by the Collaboration Committee at such meeting.  The minutes of each Collaboration Committeemeeting shall be approved or disapproved by each Party’s CollaborationCommittee representatives, and revised as necessary, at the next meeting of theCollaboration Committee.  Final minutesof each meeting shall be distributed promptly thereafter to the members of theCollaboration Committee by the chairperson.

 

### (c)                                  **Meetings**

###  

The Collaboration Committee shall meet at leastevery [***] [Confidential Treatment Required] and in addition within [***][Confidential Treatment Required] of a request by any Collaboration Committeemember to have such a meeting.  Suchmeetings shall be held at such times as are mutually agreed upon by theCollaboration Committee.  Meetings maytake place by video conference or telephone conference or such other means asthe Collaboration Committee shall decide, *provided*,*however*, that all members of theCollaboration Committee shall meet in person at least once per Contract Year,unless otherwise agreed by the Parties. Meetings held in person shall alternate between ImClone and UCBdesignated locations.  The first meetingshall be held at UCB’s facilities.

 

### (d)                                 **Appointmentof Sub-Teams and Subcommittees**

###  

The Collaboration Committee is empowered tocreate such sub-teams or subcommittees of itself as it may deem appropriate ornecessary.  Each such sub-team orsubcommittee shall report to the Collaboration Committee, who shall haveauthority to approve or reject recommendations or actions proposed subject tothe terms of this Agreement.  No sub-teamor subcommittee shall have authority to make any decision binding upon theCollaboration Committee or the Parties. For the avoidance of doubt, a Party may appoint an individual as itsrepresentative on more than one Committee.

 

## **3.4****                              ****Establishment of the Joint Patent Committee or JPC**

##  

[***] [Confidential Treatment Required] afterthe Effective Date, the Parties shall establish a JPC.  The JPC shall be comprised of one (1) seniorpatent attorney from each Party as appointed by such Party.  A Party may replace its representative fromtime to time upon written notice to the other Party.  The JPC shall exist until the expiration ortermination of this Agreement.  Alldecisions of the JPC shall be

 

26

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unanimous. In the event that a decision cannot be reached by the JPC, the disputeshall be resolved pursuant to the dispute resolution process set forth inArticle 15.  Unless the Parties otherwiseagree, the JPC shall continue after termination of this Agreement for thepurpose of co-ordinating the Parties activities in relation to Joint PatentRights but for no other purpose.

 

## **3.5****                              ****Joint Patent Committee Responsibilities**

##  

### The JPC shall be responsible for:

###  

### (a)                                  reviewing and, sofar as permitted in Article 10, approving patent, trademark and otherintellectual property strategy and, to the extent applicable, patent, trademarkand other intellectual property litigation strategy;

###  

### (b)                                 coordinatingpatent, trademark and other intellectual property related activities asallocated to it pursuant to this Agreement;

###  

### (c)                                  consulting with theCollaboration Committee with regard to proposals by the JCT for ProductTrademarks and generic names for use with respect to an Antibody Product;

###  

### (d)                                 following approvalof Product Trademarks for Antibody Products by the Collaboration Committee,obtaining and maintaining the Product Trademarks and domain names incorporatingany of the same or otherwise referencing Antibody Products;

###  

### (e)                                  periodicallyreporting to the Collaboration Committee on the status of intellectual propertymatters affecting the Development, Commercialisation and Manufacture ofAntibody Products as requested by the Collaboration Committee; and

###  

### (f)                                    in accordance withArticle 10.1(e) and subject to Articles 15.1 and 15.6, making decisionsrelating to the characterisation of any Information, Materials or Patent Rightsas ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and JointPatent Rights, including during any transfer plan or Transition Planestablished under Articles 8.6 and 12.8.

###  

## **3.6****                              ****Limitations on the Authority of Committees and Teams**

##  

Notwithstanding the Committee structureestablished pursuant to this Agreement, each Party shall retain the rights,powers and discretion granted to it under this Agreement, and no such rights,powers, or discretion shall be delegated to or vested in a Committee unlesssuch delegation or vesting of rights is expressly provided for in thisAgreement or the Parties expressly so agree in writing.  For clarity, amendments to this Agreement mayonly be made in accordance with Article 17.1.

 

## **3.7****                              ****Operational and Day-to-Day Decisions**

##  

Subject to Article 2.1(d), all operational andday-to-day decisions with respect to matters and functions allocated ordelegated to a Party in the Development Plan, the Manufacturing Plan or theCommercialisation Plan, or, with respect to Independent Indications, assignedto the Continuing Party under this Agreement, unless

 

27

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specifically reserved for approval by aCommittee hereunder, shall be deemed to be within the decision-making authorityof such Party; *provided* that allsuch decisions shall be consistent with the Development Plan, CommercialisationPlan and Manufacturing Plan, as applicable, the scope of such allocation ordelegation and the terms and conditions of this Agreement.

 

# **4.****                                     ****DEVELOPMENT OF ANTIBODY PRODUCTS**

# ** **

## **4.1****                              ****Activities**

##  

Without limiting the obligations under Article2.1 or the Development Plan, each Party shall undertake the followingactivities:

 

### (a)                                  subject to Article4.10 in relation to Materials, from time to time transfer to the other PartyImClone Know-How and UCB Know-How in such Party’s Control [***] [ConfidentialTreatment Required] to conduct its Development activities under the DevelopmentPlan in respect of Antibody Products for Agreed Indications or to conduct itsDevelopment activities in respect of Antibody Products for IndependentIndications for which the other Party is the Continuing Party;

###  

### (b)                                 conduct, or, asapplicable, assist the other Party in conducting, all relevant studies,including Clinical Studies, for Antibody Products for Agreed Indications and,[***] [Confidential Treatment Required], assist such other Party in conductingsuch studies for Antibody Products for Independent Indications for which suchother Party is the Continuing Party; and

###  

### (c)                                  in a mannerconsistent with Article 5 and the other terms of this Agreement, make, or, asapplicable, assist the other Party in making, all filings with and supportingall communications with the relevant Regulatory Authorities or othergovernmental or regulatory entities necessary to conduct such studies or toseek Regulatory Approvals for Antibody Products for Agreed Indications and, ifapplicable, Independent Indications for which the other Party is the ContinuingParty.

###  

## **4.2****                              ****Collaboration Development**

##  

Each Antibody Product shall be Developed by theParties for each Agreed Indication for such Antibody Product in accordance withthe Development Plan unless and until such Agreed Indication becomes anIndependent Indication pursuant to Article 8.

 

## **4.3****                              ****Costs**

##  

Subject to Articles 4.5, 8.9 and the otherterms of this Agreement, ImClone and UCB shall bear Development Costs asfollows:

 

### (a)                                  **DevelopmentCosts in Agreed Indications**

###  

The Parties shall share equally in allDevelopment Costs related to the Development of an Antibody Product for AgreedIndications incurred in the conduct of the Development Plan and, subject toArticle 4.5, in accordance

 

28

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with the Development Budget, regardless ofwhether such expenses are incurred before, on or after the Effective Date.

 

### (b)                                 **DevelopmentCosts in Independent Indications**

###  

The Development Costs related to theDevelopment of an Antibody Product for an Independent Indication shall be bornesolely by the Continuing Party [***] [Confidential Treatment Required].

 

## **4.4****                              ****Quarterly Reconciliation of Development Costs**

##  

The Parties shall use the procedure set out inSchedule 2 for any applicable reconciliation of Development Costs.

 

## **4.5****                              ****Development Budget**

##  

### (a)                                  Each Party shallprepare and submit to the other Party (via the JDT) for each Contract Year aproposed budget for its activities for such Contract Year, in accordance withthe Development Plan, in support of the Development of Antibody Products forAgreed Indications in a format to be agreed by the Parties, but which budgetmust include (i) line item estimates of Development Costs for each AgreedIndication by function for that Contract Year; and (ii) in respect of anyDevelopment activities which will not be completed within that Contract Yearline item estimates of the total Development Costs required to complete suchDevelopment activities on an activity-by-activity basis (regardless of whethersuch Development Costs will be incurred in that Contract Year or subsequent ContractYears).  Unless otherwise agreed by theParties, for the first Contract Year these budgets shall be submitted within[***] [Confidential Treatment Required] after the date on which theCollaboration Committee approves the initial Development Plan pursuant toArticle 4.7(a) and, thereafter, no later than [***] [Confidential TreatmentRequired] prior to the start of each subsequent Contract Year.  Unless otherwise agreed by the Parties, theCollaboration Committee shall review, revise and approve these budgets within[***] [Confidential Treatment Required] after the date on which theCollaboration Committee approves the initial Development Plan pursuant toArticle 4.7(a) and, thereafter, no later than [***] [Confidential TreatmentRequired] prior to the commencement of each Contract Year (each such approvedbudget, a **Development Budget**).  Once approved, the Collaboration Committeeshall modify the Development Budget from time to time based upon the results ofClinical Studies and other unanticipated events, *provided* that save as set out in Article 4.5(b), in no eventshall the Development Budget for a Contract Year, or, any line item estimatewithin the Development Budget for the total Development Costs required tocomplete any Development activity which will not be completed within thatContract Year, be varied by more than [***] [Confidential Treatment Required],without the consent of the JDT (or the Collaboration Committee if the JDTcannot agree), [***] [Confidential Treatment Required].  If the Development Plan is updated or amendedby the Collaboration Committee pursuant to Article 4.7 or Article 8.6 withrespect to the then-current Contract Year, the Parties shall prepare and submitproposals for any

###  

29

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### necessary amendments to the Development Budget for such Contract Yearwithin [***] [Confidential Treatment Required] after such update or amendmentto the Development Plan and the Collaboration Committee shall review, reviseand approve any necessary amendments to the Development Budget for suchContract Year [***] [Confidential Treatment Required] after such update oramendment of the Development Plan.

###  

### (b)                                 In any ContractYear, each Party shall promptly inform the other Party upon such Partydetermining that it is likely to overspend or underspend by more than [***][Confidential Treatment Required] its respective total Development Costs for anactivity set forth in the Development Budget for that Contract Year.  If in any such Contract Year a Party exceedsits budgeted costs and expenses by more than [***] [Confidential TreatmentRequired] for an activity, the Party that has so exceeded its budget shallprovide to the JDT and to the Collaboration Committee (if the matter isescalated to the Collaboration Committee because it cannot be resolved by theJDT) a full explanation for exceeding the Development Budget for suchactivity.  [***] [Confidential TreatmentRequired], the JDT or Collaboration Committee (as applicable) may, by unanimousagreement and not subject to a [***] [Confidential Treatment Required], allowsome or all of any other overspend to be included in the Development Costs asit considers equitable under the circumstances. Where any Development Budget sets out a line item estimate for the totalDevelopment Costs required to complete any activity which will not be completedwithin that Contract Year:  [***][Confidential Treatment Required].  Tothe extent that any overspend is not included in Development Costs as providedin this Article 4.5, the Party who has exceeded its budget by more than [***][Confidential Treatment Required] will be solely responsible for the overspend.

###  

## **4.6****                              ****Establishment of Joint Development Team**

##  

Within [***] [Confidential Treatment Required]after the Effective Date, the Parties shall form a Joint Development Team(JDT).

 

### (a)                                  The JDT shallconsist of up to [***] [Confidential Treatment Required] representatives ofeach Party.  Each member of the JDT shallhave appropriate experience in the development of Antibody products.  One such representative from each Party shallbe designated as that Party’s **DevelopmentTeam Leader** to act as the primary JDT contact for that Party.  Together, the Development Team Leaders willbe jointly responsible for managing the JDT. Each Party’s Development Team Leader shall be responsible for ensuringthat his/her Party carries out the activities assigned to such Party under theDevelopment Plan.  Either Party mayreplace any or all of its representatives on the JDT at any time upon written noticeto the other Party.  Any member of theJDT may designate a substitute to attend and perform the functions of thatmember at any meeting of the JDT.  EachParty may invite [***] [Confidential Treatment Required] additional employeesor consultants to attend the JDT meetings. The JDT shall be empowered to create such sub-teams or subcommittees asit may deem appropriate or necessary. Each such sub-team or subcommittee shall report to the JDT, which shallhave authority to approve or reject recommendations or actions proposed,subject to the terms of this

###  

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### Agreement.  No sub-team orsubcommittee shall have authority to make any decision binding upon the JDT orthe Parties.  The JDT shall meet, at leastonce each Calendar Quarter, or more frequently as agreed by the JDT.  To the extent that meetings are held inperson, the location of regularly scheduled JDT meetings shall alternatebetween the offices of the Parties unless otherwise agreed.  Meetings may be held by videoconference ortelephonically.  Meetings shall bechaired by a single JDT representative of one of the Parties, with the Partyresponsible for designating the chairperson alternating each Contract Year andwith ImClone being responsible for designating the chairperson for the firstContract Year.  The Party that does notprovide the chairperson shall designate a member of the JDT to record, insufficient detail, minutes of the discussions and decisions of the JDT.  Such minutes shall be circulated to theParties promptly following the meeting for review, comment and, after approvalfrom [***] [Confidential Treatment Required], distribution.  The Parties shall endeavour to manage thebusiness and meetings of the JDT in the most cost-effective way possible.

###  

### (b)                                 **JDTResponsibilities**

###  

With respect to the Development of AntibodyProducts, the JDT shall have the responsibility, except as otherwise set forthin this Agreement, of:

 

#### (i)                                     overseeing andcoordinating the day-to-day implementation of the Development Plan by theParties;

####  

#### (ii)                                  reviewingthe outline for the Development Plan and making recommendations to theCollaboration Committee with respect to the conversion of the outline for theDevelopment Plan into the initial Development Plan in accordance with Article4.7 and, following approval of the initial Development Plan by theCollaboration Committee, recommending updates and amendments to the DevelopmentPlan to the Collaboration Committee in accordance with Article 4.7;

####  

#### (iii)                               allocatingto the Parties responsibilities for Development activities that are nototherwise assigned to a Party in the Development Plan, *provided* that no such allocation shall bemade (other than as provided in the Development Plan agreed by the Parties) toa Party without such Party’s consent[***] [Confidential Treatment Required];

####  

#### (iv)                              makingdecisions regarding the design and strategic implementation of all Developmentprogrammes for Agreed Indications and selecting and appointing contractresearch organisations;

####  

#### (v)                                 selecting anddesigning Clinical Studies for Agreed Indications, and prior to thecommencement of each Clinical Study for Agreed Indications, specifying whenthat Clinical Study will be deemed to be complete for the purposes of thisAgreement;

 

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#### (vi)                              proposingprotocols, and changes to protocols, for Clinical Studies for all AntibodyProducts for Agreed Indications to the Collaboration Committee for approval;

####  

#### (vii)                           reviewingall designs and protocols for Clinical Studies for all Antibody Products forIndependent Indications that have been submitted by the Continuing Partypursuant to Article 8.3 and referring such protocols to the CollaborationCommittee;

####  

#### (viii)                        identifyingManufacturing needs and requirements of Clinical Supplies of Antibody Products,placebos and comparators and implementing an appropriate forecasting mechanismto provide the Manufacturing Coordinator with sufficient lead-time toManufacture or have Manufactured and supply the Parties’ requirements ofClinical Supplies of Antibody Products, placebos and comparators;

####  

#### (ix)                                devisingthe content of and filing strategy for Drug Approval Applications for AgreedIndications;

####  

#### (x)                                   reviewing andapproving any documents or reports to be filed by a Filing Party with the FDAor any other Regulatory Authority with respect to Agreed Indications;

####  

#### (xi)                                throughthe representatives on the JDT with regulatory expertise and in consultationwith the JCT, coordinating interactions with Regulatory Authorities anddeveloping and implementing standard operating procedures for adverse eventreporting between the Parties and compliance with other regulatory requirementsin the Territory consistent with and subject to Article 5;

####  

#### (xii)                             consultingwith the Continuing Party for an Antibody Product for an Independent Indicationwith respect to the Development of such Antibody Product for such IndependentIndication;

####  

#### (xiii)                          consultingwith the JCT as to the design and conduct of Post-Approval Studies;

####  

#### (xiv)                         in consultationwith the JCT, making recommendations to the Collaboration Committee withrespect to the packaging, labelling and language to be included in the ProductLabelling of all Antibody Products;

####  

#### (xv)                            reviewingall designs and protocols for Post-Approval Studies in support of CompendiaListings that have been submitted by either Party pursuant to Article 4.7(e)and referring such protocols to the Collaboration Committee;

####  

#### (xvi)                         exchanginginformation and facilitating cooperation and coordination between the Partiesas they exercise their respective rights and meet their respective obligationswith respect to Development under this Agreement; and

 

32

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#### (xvii)                      resolvingany complaint by a Party that the Development, Commercialisation orManufacturing activities of the other Party are adversely affecting, or mayadversely affect, the Development of Antibody Products in the Territory of theParty making the complaint.

####  

The JDT will be responsible for all other activitiesassigned to it by the Collaboration Committee with respect to AgreedIndications and shall provide the Collaboration Committee with Quarterlyreports of its activities.

 

### (c)                                  **JDTDecision-Making**

###  

Decisions of the JDT shall be made by [***][Confidential Treatment Required].  Ifthe JDT is unable to resolve a dispute regarding any issue, the matter shall beresolved pursuant to the dispute resolution process set forth in Article 15.

 

### (d)                                 **Ceasingof JDT Operations**

###  

The JDT will cease operations and have nofurther function under this Agreement on the date on which the Parties are nolonger engaging in Development of any Antibody Product for an AgreedIndication, *provided* that the JDTshall recommence operations if the Parties recommence Development of anAntibody Product for an Agreed Indication Converted pursuant to Article 8.9.

 

### (e)                                  **AnnualDevelopment Reports**

###  

The JDT shall submit annual reports withrespect to the Development of Antibody Products for Agreed Indications to theCollaboration Committee as part of each annual recommended update to theDevelopment Plan with respect to Agreed Indications.  The Continuing Party with respect to anIndependent Indication shall submit annual reports with respect to the Developmentof Antibody Products for such Independent Indication to the CollaborationCommittee.  Each such report shallinclude non-binding forecasts of the Parties’ requirements of Clinical Suppliesof Antibody Products, placebo and comparators for Agreed Indications andIndependent Indications (which forecasts shall be provided by the applicableContinuing Party) for the Territory for the then current year and the following[***] [Confidential Treatment Required] and any other related information thatthe JDT determines, or is requested by the Collaboration Committee, to include.

 

## **4.7****                              ****Development Plans and Additional Indications**

##  

### (a)                                  The JDT shallreview the outline for the Development Plan, attached hereto as Schedule 3, andshall make recommendations to the Collaboration Committee with respect to theconversion of the outline for the Development Plan into the initial DevelopmentPlan within [***] [Confidential Treatment Required] after the EffectiveDate.  The Collaboration Committee shalluse all [***] [Confidential Treatment Required] to approve the initialDevelopment Plan as soon as reasonably practicable following receipt of suchrecommendations from the JDT and in any event (unless otherwise agreed by theParties) no

 

33

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### later than [***] [Confidential Treatment Required] after the EffectiveDate.  Following agreement of theDevelopment Plan by the Collaboration Committee, the JDT shall review theDevelopment Plan at least Quarterly, and shall make recommendations to theCollaboration Committee with respect to the initial Development Plan andsubsequently any updates or amendments thereto with respect to any existingAgreed Indications or any proposed new Indications for an Antibody Product,including for an earlier line of therapy for an existing AgreedIndication.  Any such recommendationsshall include a good faith estimate of the budget for any such update oramendment, including any changes in the existing Development Budget.  Each Party shall cooperate with the JDT inpreparing such estimated budget.

###  

### (b)                                 Neither the initialDevelopment Plan nor any update or amendment to the Development Plan shallbecome effective until it is approved by the Collaboration Committee or, if theCollaboration Committee cannot reach agreement on an update or amendment, untilsuch time as may be agreed in accordance with the dispute resolution processset forth in Article 15.1(b).  Except asprovided in Article 8, any update or amendment shall provide for the jointDevelopment by the Parties of Antibody Products for the Agreed Indications andshall, subject to the proviso in Article 4.6(b)(iii), assign responsibility forDevelopment activities between the Parties considering:  (i) the allocation of responsibility set outin the initial Development Plan, (ii) the respective Territorial Lead, (iii)expertise and available resources, and (iv) the ability to use the Parties’respective existing facilities and infrastructure.

###  

### (c)                                  With respect toadditional Indications for an Antibody Product proposed by the JDT or one orboth of the Parties pursuant to Article 4.7(a), the Collaboration Committeeshall have the right with the mutual agreement of the Parties, in their soleand absolute discretion, to designate such Indication as an Agreed Indication,in which case the Collaboration Committee shall (i) approve any updates oramendments to the Development Plan and Development Budget with respect thereto,with any Disputes with respect to such updates and amendments to be resolvedpursuant to Article 15, but, for clarity, not the [***] [Confidential TreatmentRequired] process in Article 15.2, and (ii) Develop and Commercialise suchAntibody Product for such Agreed Indication as provided in this Agreement.  [***] [Confidential Treatment Required].

###  

### (d)                                 If the Parties donot agree to designate an Indication as an Agreed Indication for an AntibodyProduct and the Development and Commercialisation of such Antibody Product forsuch Indication is not, at that time, reasonably likely to have an adverseeffect on the Development and Commercialisation of the Antibody Product forAgreed Indications in the Territory, then the Party that did not object to suchdesignation shall have the right, on written notice to the other Party providedwithin [***] [Confidential Treatment Required] after the meeting of theCollaboration Committee in which the Indication was rejected pursuant toArticle 4.7(c), to Develop and conduct Post-Approval Studies for such AntibodyProduct for such Indication in the Territory and to seek, obtain and maintainRegulatory Approval for and Commercialise such Antibody Product for suchIndication in any country in which such Party is the

###  

34

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Territorial Lead, in each case as anIndependent Indication pursuant to Article 8 and the other Party shall have noright to Develop or to seek, obtain or maintain Regulatory Approval for suchIndication in the countries for which such other Party is Territorial Leadexcept as permitted in Article 8.9.  AnyDispute as to whether the Development or Commercialisation of a new Indicationfor an Antibody Product is reasonably likely to have an adverse effect on theDevelopment and Commercialisation of an Antibody Product for Agreed Indicationsin the Territory shall be subject to the dispute resolution provisions ofArticle 15[***] [Confidential Treatment Required].

###  

### (e)                                  Notwithstandinganything in this Agreement to the contrary, neither Party shall have the rightto Develop an Antibody Product for an Indication other than an AgreedIndication or an Independent Indication, including for another line of therapyfor an existing Agreed Indication or Independent Indication, inside or outsideof the scope of this Agreement without the consent of the other Party.  For clarity, each Party shall have the rightto conduct Post-Approval Studies in support of Compendia Listings for AntibodyProducts for new Indications in accordance with the applicableCommercialisation Plan and Applicable Law, provided that all designs andprotocols for such Post-Approval Studies in support of Compendia Listings havebeen submitted to the JDT for review and, in the case of the protocols,reviewed by the Collaboration Committee, prior to commencement of thatPost-Approval Study.

###  

### (f)                                    [***] [ConfidentialTreatment Required]

###  

## **4.8****                              ****Compliance with Applicable Law**

##  

In performing Development activities, eachParty shall comply with all Applicable Law.

 

## **4.9****                              ****Clinical Studies**

##  

### (a)                                  **AgreedIndications**

###  

The Parties shall conduct Clinical Studies for Antibody Products forAgreed Indications in accordance with the Development Plan.  All clinical data and reports related toClinical Studies for Antibody Products for Agreed Indications shall be [***][Confidential Treatment Required].  EachParty shall have full use, for any purpose consistent with this Agreement, ofall such data and reports related to Clinical Studies in Agreed Indications foran Antibody Product.  Once finalised, alldata, database information and reports from all Clinical Studies for AntibodyProducts for Agreed Indications shall be centralised and held at a location tobe chosen by the Collaboration Committee, with a duplicate set available toeach Party for deposit at a site of its own selection.

 

### (b)                                 **IndependentIndications**

###  

All clinical data and reports related to Clinical Studies forIndependent Indications for an Antibody Product shall [***] [ConfidentialTreatment

 

35

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Required] and that Continuing Party shall have the right to control allsuch data, database information and reports from Clinical Studies for suchIndependent Indication, including maintaining the foregoing at a separatelocation.  The Non-Continuing Party withrespect to an Independent Indication for an Antibody Product shall not have theright to use, access or reference such data, information or reports, *provided* that, subject to the restrictionson Development and marketing set forth in Article 8.1, the Non-Continuing Partyshall have the right to reference such data and reports with respect to suchIndependent Indication as are necessary to obtain and maintain RegulatoryApprovals for Agreed Indications for such Antibody Product or for otherIndependent Indications for which such Non-Continuing Party is the ContinuingParty, in each case, in the countries in which the Non-Continuing Party is theTerritorial Lead.

 

## **4.10****                       ****Development Materials**

##  

The Parties agree that (i) to the extent that aParty would otherwise be required to transfer to the other Party Materials thatare [***] [Confidential Treatment Required]for the other Party to conduct itsDevelopment activities under this Agreement, the transfer of such Materialsshall be at the discretion of the transferring Party; (ii) any Materialsprovided by one Party to the other Party pursuant to this Agreement and anyMaterial produced against or with, or otherwise derived from, such Materialsshall be used solely for the Development activities as provided in theDevelopment Plan or the plan for Independent Indications referred to in Article8.3(a), and in material compliance with all Applicable Law and, except asagreed by the Parties, Materials provided to one Party by the other shall notbe made available to any Third Party by the receiving Party without the priorwritten consent of the providing Party [***] [Confidential Treatment Required];(iii) any Materials provided by one Party to the other Party pursuant to thisAgreement are provided without any warranties, express or implied; and (iv) allright, title and interest in and to any Materials provided by one Party to theother Party pursuant to this Agreement, including any replication, copy orprogeny thereof, shall be, and remain, vested in such providing Party.  Any Dispute in relation to this Article 4.10shall be resolved by the Collaboration Committee and if the CollaborationCommittee is unable to resolve such Dispute, the Dispute shall be decided underthe provisions of Article 15 ([***] [Confidential Treatment Required]).

 

# **5.****                                     ****REGULATORY AFFAIRS**

# ** **

## **5.1****                              ****Rights and Responsibilities with respect to Antibody Products**

##  

### (a)                                  The Parties shallconsult and cooperate with each other on all matters relating to, and incommunications with, Regulatory Authorities. The Parties will coordinate all communications with RegulatoryAuthorities in [***] [Confidential Treatment Required] to ensure consistent andclear communication with those Regulatory Authorities.  In addition, each Party will discuss inadvance with the other Party any planned communication with any Regulatory Authorityin [***] [Confidential Treatment Required].

###  

### (b)                                 Unless otherwiseagreed by the Parties or otherwise provided in this Agreement, the TerritorialLead shall, as between the Parties, be responsible

 

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for filing and procuring the submission of the INDs and Drug ApprovalApplications and seeking, obtaining and maintaining Regulatory Approvals forAntibody Products for Agreed Indications in each country for which it is theTerritorial Lead (the Party conducting such filing and procuring in a country,the **Filing Party**with respect tosuch country), *provided* that if aParty is a Manufacturer of an Antibody Product, then such party shall be theFiling Party with respect to submissions and communications governed by thisArticle 5 with respect to such Manufacture and in any event the ManufacturingCoordinator and the Manufacturer, as applicable, shall provide the other Partyor Parties (as the case may be) all such chemistry, manufacturing and controlsmaterial and such other data (or a drug master file or equivalent outside theUnited States containing the same) and grant each Party such rights ofreference as are in each case necessary to obtain and maintain such INDs, DrugApproval Applications and Regulatory Approvals as set forth in Article7.5.  Notwithstanding the foregoing, eachParty’s obligation to obtain Regulatory Approvals shall be limited as set outin Articles 2.1(a)(ii) and 2.1(a)(iii) (as applicable) unless otherwise agreedin writing by the Parties.  For clarity,as set forth in Article 8.2 and 8.4(a), the Continuing Party shall, exceptwhere the Manufacturer is the Filing Party as set out above, be the FilingParty with respect to an Antibody Product for an Independent Indication forwhich it is the Continuing Party (i) for an IND throughout the Territory, and(ii) for a Drug Approval Application in the Territory for which it is theTerritorial Lead.

###  

(c)                                   The Filing Party shall comply with allApplicable Law relevant to its responsibilities pursuant to Articles 5.1(a) and(b).  The Filing Party shall use [***][Confidential Treatment Required] to perform the activities contemplated underthis Agreement, with the oversight of the JDT and in accordance with theDevelopment Plan for the Agreed Indications. Prior to submitting an IND, Drug Approval Application or other documentin support of a Regulatory Approval for an Antibody Product for an AgreedIndication, the Parties, through the JDT, shall consult and cooperate inpreparing such filings.  Each Party shallhave the right to review and comment on all INDs, Drug Approval Applicationsand other documents in support of a Regulatory Approval for an Antibody Productfor an Agreed Indication in accordance with specific timelines or otherarrangements agreed upon by the JDT, and no such filing for an Antibody Productfor an Agreed Indication shall be made unless the JDT has approved the form andcontent of such filing.  With respect toan Antibody Product for an Independent Indication, the Continuing Party forsuch Independent Indication shall, subject to Article 2.1(d), control thescope, content and timing of filing of INDs, Drug Approval Applications andother documents in support of Regulatory Approvals with respect to AntibodyProducts in such Independent Indication in accordance with Article 8. Unlessotherwise required by relevant Regulatory Authorities, this Agreement orApplicable Law, all regulatory documents shall be held by the Filing Party at asite of its selection and the Filing Party shall provide the other Party with aduplicate set of such regulatory documents to be held by the other Party at asite of the other Party’s own selection. Unless otherwise agreed by the JDT and subject to the terms of thisAgreement, the Filing Party shall own all regulatory submissions, including allINDs, Drug Approval

 

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Applications, Regulatory Approvals and othergovernment licences, approvals and certificates for Antibody Products in theapplicable jurisdiction.  For an AntibodyProduct for an Independent Indication, where the Filing Party is operating in acountry where it is not the Territorial Lead, the Territorial Lead shallprovide all reasonable cooperation and assistance to the Filing Party withrespect to such regulatory submissions.

 

### (d)                                 Except as otherwiseexpressly provided in this Agreement, without the prior written approval of theCollaboration Committee, the Filing Party shall not transfer title or otherwisedispose of or grant any rights or interests, including any rights of reference,in or to, any INDs, Drug Approval Applications, Regulatory Approvals or othergovernment licences, approvals or certificates for an Antibody Product in theTerritory, or otherwise impair the other Party’s rights in such INDs, DrugApproval Applications, Regulatory Approvals or other government licences,approvals or certificates.

###  

### (e)                                  Within a reasonabletime prior to filing, the Filing Party shall provide the other Party with acopy of all documents or reports to be filed with the FDA or any otherRegulatory Authority under this Agreement (or, if not feasible, the FilingParty shall provide the other Party with on-site or electronic access to suchdocuments or reports, with reasonable advance written notice of theavailability of each such document or report), including with respect to anyIND, Drug Approval Application, Regulatory Approval or other governmentlicence, approval or certificate for an Antibody Product, and any data packagesin support thereof.  The JDT for AgreedIndications, and the Continuing Party for an Independent Indication, shallapprove the form and content of all such documents or reports prior tofiling.  Other communications andinteractions of either Party with Regulatory Authorities related to AntibodyProducts shall be subject to the terms of Article 5.4.

###  

### (f)                                    The content andlanguage of the proposed Product Labelling, and all changes to it, includingall safety-related package insert changes for Antibody Products shall beprepared by the JDT for Agreed Indications and by the Continuing Party, inconsultation with the JDT, for any Independent Indication, and shall beapproved by the Collaboration Committee prior to submission to the applicableRegulatory Authority.

###  

### (g)                                 Nothing in thisArticle 5.1 is intended or shall be construed to prevent or delay a Party orits Affiliates from making any filing with or submission to, or responding torequests from, or complying with any requirements of, the RegulatoryAuthorities in the Territory as required by Applicable Law, *provided* that such Party or its Affiliatesused [***] [Confidential Treatment Required], as appropriate in suchcircumstances, to comply with the foregoing provisions of this Article 5.1.

###  

### (h)                                 Notwithstandinganything to the contrary in this Agreement, and subject to the terms of Article11, the Filing Party shall have the right to receive from the other Party (andthe other Party shall provide to the Filing Party) any regulatory data orInformation Controlled by the other Party related to an Antibody Product, whichthe Filing Party, as the holder of any IND, Drug Approval Application,Regulatory Approval or other government licences,

 

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approvals or certificates in the applicable jurisdiction, is required tohave by Applicable Law, or to which a Regulatory Authority having jurisdictionwishes to have access, or which the Filing Party reasonably requires in orderto carry out its responsibilities pursuant to this Agreement.

###  

## **5.2****                              ****Access to INDs and Drug Approval Applications**

##  

To the extent that it is reasonably possible todo so, each Filing Party shall (a) in relation to Agreed Indications, grant theother Party, and (b) in relation to Independent Indications, grant to theContinuing Party, a right of access and reference to (and if permitted, name ita party of record on) all INDs, Drug Approval Applications, RegulatoryApprovals and other government licences, approvals or certificates and shallpromptly notify Regulatory Authorities of (and as soon as is reasonablypracticable after such notification take all actions reasonably necessary toeffect or evidence) the other Party’s right of access and reference to (and ifpermitted, naming the other Party as a party of record on) such INDs, DrugApproval Applications, Regulatory Approvals and other government licences,approvals or certificates.

 

## **5.3****                              ****Adverse Event Reporting; Customer Complaints**

##  

### (a)                                  Each Party shallmaintain a record of, and where required by Applicable Law follow-up on, allnon-medical and medical product-related complaints and reports of adverseevents that it receives with respect to any Antibody Product.  Each Party shall promptly notify the otherParty of any complaint or adverse event report received by it and shall providethe other Party with a copy of such complaint or adverse event report as soonas reasonably possible following initial receipt (and in any event no laterthan (i) within [***] [Confidential Treatment Required] of initial receipt forany complaint or adverse event report relating to death or life threateningillness, or (ii) within [***] [Confidential Treatment Required] of initialreceipt for any other complaint or adverse event report, or, in each case, suchshorter period as may be required to comply with Applicable Law).

###  

### (b)                                 The Filing Partyshall be responsible for reporting to Regulatory Authorities any adverse eventsand safety issues for such Antibody Product, in compliance with therequirements of Applicable Law, and shall simultaneously provide the otherParty with a copy of such report.  Ifthere is reasonably sufficient time available to do so, the Filing Party shallgive the other Party an opportunity to review, and the Parties shall consultwith each other, prior to submission of any such report.

###  

### (c)                                  As soon asreasonably practicable, the Parties shall, through their pharmacovigilancedepartments, meet, determine and adopt detailed procedures for the collection,review, assessment, tracking and filing of Information related to complaintsand adverse events associated with Antibody Products and shall meetperiodically to update the procedures.

###  

## **5.4****                              ****Communications**

##  

### (a)                                  Inaddition to the responsibilities in Article 5.1, each Filing Party shall haveprimary and, except as may be required by Applicable Law or requested by

###  

39

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any Regulatory Authority, exclusive responsibility for allcorrespondence and for any official communications with Regulatory Authoritiesin the jurisdictions and for the Indications for which it is the FilingParty.  Each Party shall reasonablycooperate with the other Party regarding any direct communications with theRegulatory Authorities.

###  

### (b)                                 Each of the Partiesshall have the right to (i) be present at all scheduled meetings withRegulatory Authorities having jurisdiction in any part of the Territory, and(ii) be present on all telephone calls with Regulatory Authorities havingjurisdiction in any part of the Territory where any matter which may affect itsactivities or studies is to be discussed.

###  

### (c)                                  Except as may berequired by Applicable Law or requested by the Filing Party or any RegulatoryAuthority having jurisdiction with respect to a country or matter, the otherParty shall not independently communicate regarding an Antibody Product withany Regulatory Authority having jurisdiction with respect to such country ormatter.  The other Party shall keep theFiling Party informed of any such required communications.

###  

### (d)                                 Regarding theManufacture of an Antibody Product, each of the Parties shall have the right(and the Manufacturing Coordinator shall procure that the Manufacturer shall,at the request of the Filing Party, have the obligation), to be present at allmeetings and on all telephone calls with, and at all inspections by, RegulatoryAuthorities where issues regarding the Manufacturing of such Antibody Productare to be discussed or where required by Applicable Law.

###  

### (e)                                  Each Party shallpromptly notify and provide the other Party with a copy of any correspondenceor other reports or complaints submitted to or received by the first Party fromany Regulatory Authority, other governmental authority, industry association orother Third Party (i) claiming that any Promotional Materials or Promotional orDetailing activities are inconsistent with the Product Labelling or areotherwise in violation of any Applicable Law, or (ii) making any other claim orassertion with regard to an Antibody Product that could be reasonably expectedto have an adverse effect on the Development, Commercialisation or Manufactureof such Antibody Product in the Territory, including any communication withrespect to safety.

###  

## **5.5****                              ****Recalls**

##  

### (a)                                  The Parties shallexchange their internal standard operating procedures as to product recalls andmarket withdrawals (**SOPs**)reasonably promptly after the first filing of a Drug Approval Application foran Antibody Product and thereafter reasonably promptly after any time such SOPsare approved or modified.  In the eventthat, in a country, a Party determines that an event, incident or circumstancehas occurred which may result in the need for a recall or market withdrawal orstock recovery (collectively referred to as a **Recall**),of Antibody Product or any lot(s) of Antibody Product, such Party shall promptlynotify the other Party in writing.

###  

### (b)                                 The TerritorialLead in a country shall have the right to determine whether and upon what termsand conditions to Recall an Antibody Product in such

 

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country.  Prior to making anyRecall decision, each Party shall consult with the other Party.  The Filing Party shall be responsible fordiscussions with Regulatory Authorities within the applicable country regardingall aspects of the Recall decision and the execution of any Recall.  Any costs or expenses of any Recall shall bea Commercialisation Expense for the applicable country for an Agreed Indicationand shall be borne by the Continuing Party with respect to an IndependentIndication, *provided* that, to theextent that such Recall with respect to an Agreed Indication or an IndependentIndication is caused by or results from the negligence or wilful misconduct ofa Party, its Affiliates or permitted sublicensees or Distributors, or theirrespective directors, officers, employees or agents, [***] [ConfidentialTreatment Required].  UCB and ImCloneshall each maintain complete and accurate records of any Recall it has theright to control pursuant to this Article 5.5 for such periods as may berequired by legal requirements, but in any event for no less than [***][Confidential Treatment Required].

###  

## **5.6****                              ****Applications for Regulatory Exclusivity**

##  

The Parties recognise that exclusivity rightsgranted or provided for under Applicable Law may be commercially significant toAntibody Products.  To the extentpermitted by such Applicable Law, as between the Parties, the Territorial Leadfor a country with respect to Agreed Indications and the Continuing Party foran Independent Indication shall have the exclusive right to file for, requestand maintain any regulatory exclusivity rights for Antibody Product in suchcountry (including data and marketing exclusivity rights, regulatoryexclusivity rights based upon an orphan drug designation of an Antibody Productfor an Agreed Indication or Independent Indication and exclusivity followingsubmission of pediatric study data) and to conduct and prosecute anyproceedings or actions to enforce such regulatory exclusivity rights incountries for which it is the Territorial Lead. For the avoidance of doubt, any costs incurred by the Parties inobtaining, maintaining or enforcing such exclusivity rights shall be treated asDevelopment Costs, except to the extent that such costs relate solely to anIndependent Indication (with respect to Development or Post-Approval Studies,in the Territory and with respect to Commercialisation (except Post-ApprovalStudies), in the countries for which the Continuing Party is the TerritorialLead) [***] [Confidential Treatment Required].

 

# **6.****                                     ****COMMERCIALISATION OF ANTIBODY PRODUCTS**

# ** **

## **6.1****                              ****Territorial Lead**

##  

### (a)                                  The TerritorialLead shall use [***] [Confidential Treatment Required]to maximise the OperatingProfit of each Antibody Product for Agreed Indications in the countries forwhich it is the Territorial Lead.

###  

### (b)                                 The TerritorialLead shall be responsible for the selection, appointment and management of thesublicensees and Distributors in the countries for which it is the TerritorialLead in accordance with the provisions of Article 6.2.

 

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## **6.2****                              ****Distributors and Co-Promotion**

##  

### (a)                                  Subject to Articles6.2(b) and Article 9.5, a Territorial Lead may appoint Distributors orCo-Promotion partners in any country for which it is the Territorial Lead,subject to first obtaining the agreement of the other Party, [***][Confidential Treatment Required]

###  

### (b)                                 Prior to appointingany Third Party as a Distributor or to Co-Promote an Antibody Product in anycountry for which it is the Territorial Lead, the Territorial Lead shall givethe other Party written notice of its intention to do so (such notice toinclude a description, in reasonable detail, of the nature and scope of therelevant Distributor or Co-Promotion activity) and shall give the other Partythe right of first refusal to undertake that Distributor or Co-Promotionactivity itself.  Within [***][Confidential Treatment Required] of receipt of such notice, the other Partyshall, by notice in writing to the Territorial Lead, either:  (i) elect not to undertake that Distributoror Co-Promotion activity, in which case the Territorial Lead may proceed withthe appointment of the Third Party to undertake that Distributor orCo-Promotion activity pursuant to Article 6.2(a), *provided* that the Territorial Lead shall not permit theappointed Third Party to undertake any Distributor or Co-Promotion activitythat falls outside the description of the nature and scope of the Distributoror Co-Promotion activity that was included with such notice; or (ii) elect toundertake that Distributor or Co-Promotion activity, in which case the otherParty shall be entitled to undertake that Distributor or Co-Promotion activityunder the direction of the Territorial Lead and in accordance with the terms ofthis Agreement, with all [***] [Confidential Treatment Required] costs andexpenses incurred by the other Party in undertaking that Distributor orCo-Promotion activity being treated as [***] [Confidential Treatment Required]and Loss except to the extent that such costs and expenses relate solely to anIndependent Indication in which case such costs shall be borne by theapplicable Continuing Party unless and until such Independent Indication isconverted into a Converted Agreed Indication, whereupon the Non-ContinuingParty shall reimburse the Continuing Party for such costs as provided inArticle 8.9.  If the other Party fails torespond to any written notice of the Territorial Lead’s intention to appoint aThird Party to undertake any Distributor or Co-Promotion arrangement within therequired [***] [Confidential Treatment Required] period, the other Party willbe deemed to have elected not to undertake that Distributor or Co-Promotionactivity.

###  

## **6.3****                              ****Establishment of Joint Commercialisation Team**

##  

No later than [***] [Confidential Treatment Required]before the anticipated date of the first Regulatory Approval, or earlier ifagreed by the Collaboration Committee, the Parties shall establish a JointCommercialisation Team (JCT) to facilitate the Commercialisation of AntibodyProducts on a global basis.

 

### (a)                                  **JCTMembers**

###  

The JCT shall consist of up to [***] [Confidential Treatment Required]representatives of each Party.  Eachmember of the JCT shall be an individual with operational experience in the Commercialisationand marketing of

 

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pharmaceutical products.  TheDevelopment Team Leader for each Party may also be one of the representativesfor such Party on the JCT.  Onerepresentative from each Party on the JCT shall be designated as that Party’s **Commercialisation Team Leader** to act as theprimary JCT contact for that Party. Together, the Commercialisation Team Leaders will be jointly responsiblefor managing the JCT.  Each Party’sCommercialisation Team Leader shall be responsible for ensuring that his/herParty carries out the activities assigned to such Party under theCommercialisation Plan.  Either Party mayreplace any or all of its representatives on the JCT at any time upon writtennotice to the other Party.  Any member ofthe JCT may designate a substitute with suitable experience to attend andperform the functions of that member at any meeting of the JCT.  Each Party may invite (at its discretion andwith the consent of the other Party, [***] [Confidential Treatment Required]additional employees or consultants to attend JCT meetings.  The JCT shall meet at least [***][Confidential Treatment Required], or more frequently as agreed by theJCT.  The location of regularly scheduledJCT meetings shall alternate between the offices of the Parties unlessotherwise agreed.  Meetings may be heldby videoconference or telephonically. Meetings shall be chaired by a single JCT representative of one of theParties, with the Party responsible for designating the chairperson alternatingeach Contract Year.  The CollaborationCommittee shall decide which Party will be responsible for designating thechairperson for the Contract Year in which the JCT is established.  The Party that does not provide thechairperson shall designate a member of the JCT to record, in sufficientdetail, minutes of the discussions and decisions of the JCT.  Such minutes shall be circulated to theParties promptly following the meeting for review, comment and, after approvalfrom [***] [Confidential Treatment Required], distribution.  The Parties shall endeavour to manage thebusiness and meetings of the JCT in the most cost-effective way possible.

 

### (b)                                 **Responsibilitiesof the JCT**

###  

The JCT shall, during the Development of an Antibody Product, coordinatewith the JDT and the JMT those activities deemed necessary for successfulCommercialisation of Antibody Product for Agreed Indications in the Territoryupon Regulatory Approval.  The JCT shallbe responsible for preparing the Commercialisation Plan and theCommercialisation Budget (and recommending updates and amendments to theCommercialisation Plan and Commercialisation Budget as necessary) as furtherset forth in Articles 6.5 and 6.8, and for overseeing and implementing theactivities contemplated under the Commercialisation Plan and under the otherrelevant portions of this Article 6. The JCT shall also coordinate with the JDTin developing and implementing standard operating procedures for adverse eventreporting and compliance with regulatory requirements in the Territory, consistentwith Article 5.  The JCT shall provideQuarterly reports to the Collaboration Committee of its activities.

 

### (c)                                  **JCTDecision-Making**

###  

Decisions of the JCT shall be made by [***] [Confidential TreatmentRequired].  If the JCT is unable toresolve a dispute regarding any issue, the

 

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matter shall be resolved pursuant to the dispute resolution process setforth in Article 15.

 

### (d)                                 **AnnualProduction Requirements**

###  

The JCT shall be responsible for preparing and submitting to theCollaboration Committee annual commercial production requirement reports withrespect to each Antibody Product as part of each annual recommended update tothe Commercialisation Plan.  Such reportshall include a non-binding forecast of requirements for Commercial Supplies ofAntibody Products for the Territory for the then current year and the following[***] [Confidential Treatment Required] and any other related information thatthe JCT determines to include.

 

## **6.4****                              ****JCT and Territorial Lead Responsibilities**

##  

### (a)                                  Each TerritorialLead has the right and responsibility to Commercialise Antibody Products in themanner it deems appropriate, but subject always to its obligations under thisAgreement including those set out in Articles 2.1 and 8 and this Article6.  The Territorial Lead shall book allsales of Antibody Products in the countries for which it is the TerritorialLead.  If the JCT determines that anyCommercialisation activities for Antibody Products should be conducted jointlyor on a coordinated basis between the Parties, such activities shall becoordinated through the JCT.  The Partiesnow agree that, in addition to those matters set forth in Article 6.3(b), it islikely they will wish to coordinate the following matters, and that unless anduntil the Parties determine otherwise, and subject always to Articles 6.3(c)and 3.7, the JCT shall be responsible for:

###  

#### (i)                                     addressingstrategic issues with relevance to Antibody Products for Agreed Indicationsthroughout the Territory (e.g., branding, pricing, reimbursement issues,regulatory issues, product positioning) and consulting with the ContinuingParty with respect to such issues for its Independent Indications, and makingrecommendations to the Collaboration Committee for approval with respect toproduct positioning, pricing and reimbursement issues for all AntibodyProducts;

####  

#### (ii)                                  decidingany activities that the Parties shall undertake jointly in order toCommercialise Antibody Products for Agreed Indications on a world-wide basis(e.g., pre-launch activities, market research, launch, post—launchmarketing, Promotion, education, developing Promotional Materials,participation in congresses and publications) (collectively, the **Joint Activities**);

####  

#### (iii)                               coordinating,reviewing and commenting on Post-Approval Studies for Antibody Products, *provided* that, subject to Article 4.7(e), each Party shallhave the right to pursue Post-Approval Studies in the Territory in support ofCompendia Listings in the countries for which it is the Territorial Lead;

 

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#### (iv)                              assistingthe JDT with the preparation of recommendations to the Collaboration Committeewith respect to the packaging, labelling and language to be included in theProduct Labelling of all Antibody Products;

####  

#### (v)                                 coordinatingcommercial manufacturing production requirements of Antibody Products;

####  

#### (vi)                              inconsultation with the JPC, selecting, and recommending to the CollaborationCommittee for approval, Product Trademarks and generic names for AntibodyProducts;

####  

#### (vii)                           developingand updating a Commercialisation Plan for each Antibody Product pursuant toArticle 6.5;

####  

#### (viii)                        developingand approving a publication and scientific symposia strategy and a calendar ofkey scientific and clinical meetings at which the Parties will seek to presentthe results of Clinical Studies for the Antibody Product for AgreedIndications; and

####  

#### (ix)                                resolvingany complaint by a Party that the Development, Commercialisation orManufacturing activities of the other Party are adversely affecting theCommercialisation of Antibody Products in the countries for which the Partymaking the complaint is the Territorial Lead.

####  

### (b)                                 Subject to Articles2.1, 3.7, 6.4(a), 6.7 and 8, the TerritorialLead shall be responsible for the Commercialisation of Antibody Products in thecountries for which it is the Territorial Lead in a manner consistent with theCommercialisation Plan, including:

###  

#### (i)                                     tactical issues,for example, sales force allocation and disposition;

####  

#### (ii)                                  determiningPromotional Materials suitable for each such country in accordance with Article6.12;

####  

#### (iii)                               preparingand implementing the Country Plan and monitoring the Commercialisation Budgetsand forecasts for each such country; and

####  

#### (iv)                              bookingsales, taking orders, distributing, handling returns, and contracting andadministering accounts.

####  

## **6.5****                              ****Commercialisation Plan**

##  

### (a)                                  The JCT shalldevelop, for approval by the Collaboration Committee, a Commercialisation Planfor Antibody Products, which Commercialisation Plan shall:

###  

#### (i)                                     outline the overallstrategy for the Commercialisation of Antibody Products throughout theTerritory, including the strategy for positioning of the Antibody Products;

 

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#### (ii)                                  identifymanufacturing needs and requirements of Commercial Supplies of AntibodyProducts and identify an appropriate forecasting mechanism to provide theManufacturer with sufficient lead-time to Manufacture and to supply theParties’ requirements of Commercial Supplies of Antibody Products;

####  

#### (iii)                               identifyJoint Activities; and

####  

#### (iv)                              addressany other issue where the Parties wish to adopt a coordinated approachthroughout the Territory.

####  

### (b)                                 A proposed initialCommercialisation Plan for Antibody Products shall be developed and forwardedby the JCT to the Collaboration Committee, and the Collaboration Committeeshall approve an initial Commercialisation Plan for Antibody Products no laterthan [***] [Confidential Treatment Required] before a Party is expected to filethe first Drug Approval Application for an Antibody Product.  Thereafter, the JCT shall review theCommercialisation Plan at least Quarterly, and shall make recommendations withrespect to any updates or amendments thereto to the Collaboration Committee.  Either Party may at any time propose anamendment to the Commercialisation Plan. Any such recommendations with respect to Agreed Indications shallinclude a good faith estimate of the budget for any such update or amendment,including any changes in the existing Commercialisation Budget.  Each Party shall cooperate with the JCT inpreparing such estimated budget.  Subjectto Article 6.7(b), all updates or amendments to the Commercialisation Plan mustbe approved by the Collaboration Committee or, if the Collaboration Committeecannot reach agreement on an update or amendment, the dispute resolutionprocess set forth in Article 15.

###  

## **6.6****                              ****Country Plan**

##  

### (a)                                  From and after thedate on which the first Commercialisation Plan is agreed, the Territorial Leadfor each of the United States, Europe and Japan and any other countries inrespect of which marketing approval for any Antibody Product is being sought,shall develop and submit to the JCT no less than [***] [Confidential TreatmentRequired] prior to the commencement of each Contract Year, a commercialisationplan and budget (**Country Plan**) foreach Antibody Product in such country for the immediately following ContractYear.  Each Country Plan shall set outthe work activities, including the number and position of Details for suchAntibody Product to be carried out in such country in such Contract Year, in amanner consistent with the Commercialisation Plan and Commercialisation Budget,but taking into account the specific circumstances appropriate to the Commercialisationof Antibody Products in such country. The Country Plan shall be developed to a standard and timing consistentwith other products marketed by the Territorial Lead in that country.

###  

### (b)                                 If theCommercialisation Plan is amended in accordance with Article 6.5(b) or theCommercialisation Budget is amended in accordance with Article 6.8(b), eachTerritorial Lead shall promptly amend the Country Plans relating to thecountries for which it is Territorial Lead to conform with such amended

 

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Commercialisation Plan and/or Commercialisation Budget and resubmit anysuch amended Country Plans to the JCT.

###  

### (c)                                  Each TerritorialLead may amend any such Country Plan at any time on no less than [***][Confidential Treatment Required] advance written notice to the JCT, *provided* that such Country Plan, asamended, is consistent with the Commercialisation Plan and theCommercialisation Budget.

###  

### (d)                                 Any Disputeregarding whether or not a Country Plan is consistent with theCommercialisation Plan or the Commercialisation Budget shall, at the request ofeither Party, be determined by the JCT and thereafter in accordance withArticle 15.

###  

## **6.7****                              ****Implementation of Country Plan; Deviations**

##  

### (a)                                  The TerritorialLead shall Commercialise Antibody Products in each country for which it is theTerritorial Lead, in accordance with the Country Plan for such country; *provided*, *however*,that neither Party shall undertake any activity that is inconsistent with theCommercialisation Plan (except as provided in Article 6.7(b)) or with itsobligations under this Agreement including its obligation to use [***][Confidential Treatment Required]to Commercialise Antibody Product for AgreedIndications in the countries for which it is the Territorial Lead.

###  

### (b)                                 Where time does notpermit amendment as provided in this Article 6, a Party may deviate from anagreed Commercialisation Plan or Country Plan with the prior written consent ofthe other Party’s Commercialisation Team Leader [***] [Confidential TreatmentRequired]. Where one Party consents to a deviation from an agreedCommercialisation Plan or Country Plan in accordance with this Article 6.7(b),the other Party shall promptly brief the JCT on the reasons for the deviationand on the course of action pursued.

###  

## **6.8****                              ****Commercialisation Budget**

##  

### (a)                                  In conjunction withthe approval of the first Commercialisation Plan or, in any event, no laterthan [***] [Confidential Treatment Required] after the first CommercialisationPlan is agreed, and thereafter, no later than [***] [Confidential TreatmentRequired] prior to the start of each subsequent Contract Year, each Party shallprepare and submit to the other Party (via the JCT) a proposed budget for itsactivities for the ensuing Contract Year, as set forth in the CommercialisationPlan, in support of the Commercialisation of Antibody Products (other than forIndependent Indications for which it is the Continuing Party) in a format to beagreed by the Parties, but which budget must include (i) line itemestimates of expected Reimbursable Commercial Costs and forecasted Net Receipts(calculated as set out in Schedule 2) for the ensuing Contract Year for thecountries for which that Party is Territorial Lead; and (ii) in respect of anyCommercialisation activities which will not be completed in that Contract Year,line item estimates of the total Reimbursable Commercial Costs required tocomplete such Commercialisation activities in countries for which that Party isTerritorial Lead on an activity-by-activity basis (regardless of whether suchReimbursable Commercial Costs will be

 

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incurred in that Contract Year or subsequent Contract Years).  The Collaboration Committee shall review,revise and approve these budgets in relation to the first such budget within [***][Confidential Treatment Required] after receipt thereof and thereafter no laterthan [***] [Confidential Treatment Required] prior to the commencement of eachContract Year (each such approved budget, a **CommercialisationBudget**).  Once approved, theCollaboration Committee, upon recommendation of the JCT, shall modify theCommercialisation Budget from time to time based upon changes in patent status,new product launches by competitors, adverse drug reactions, the results ofclinical studies, changes in pricing and reimbursement regimes and otherunanticipated events.  If theCommercialisation Plan is updated or amended by the Collaboration Committeepursuant to Article 6.5(b) with respect to the then-current Contract Year, theParties shall prepare and submit proposals for any necessary amendments to theCommercialisation Budget for such Contract Year within [***] [ConfidentialTreatment Required] after such update or amendment to the CommercialisationPlan and the Collaboration Committee shall approve any necessary amendments toCommercialisation Budget for such Contract Year within [***] [ConfidentialTreatment Required] after such update or amendment of the CommercialisationPlan.

###  

### (b)                                 The JCT shallreview the Commercialisation Budget at least Quarterly, and shall makerecommendations with respect to any updates or amendments thereto to theCollaboration Committee.  Either Partymay at any time propose an amendment to the Commercialisation Budget.  No update or amendment to theCommercialisation Budget shall become effective unless it is approved by theCollaboration Committee or, if the Collaboration Committee cannot reachagreement on an update or amendment, the dispute resolution process set forthin Article 15.

###  

### (c)                                  In any ContractYear, each Party shall promptly inform the other Party upon such Partydetermining that it is likely to overspend or underspend by more than [***][Confidential Treatment Required] its respective total Reimbursable CommercialCosts for an activity set forth in the Commercialisation Budget for thatContract Year.  If in any such ContractYear a Party exceeds its budgeted costs and expenses by more than [***][Confidential Treatment Required] for an activity, the Party that has soexceeded its budget shall provide to the JCT and to the Collaboration Committee(if the matter is escalated to the Collaboration Committee because it cannot beresolved by the JCT) a full explanation for exceeding the CommercialisationBudget for such activity.  If and to theextent that any such overspend was [***] [Confidential Treatment Required] ofthe applicable Party, then, provided the applicable Party has promptly notifiedthe other Party of such overspend and used [***] [Confidential TreatmentRequired] to mitigate the size of such overspend, such overspend shall beincluded in Reimbursable Commercial Costs and used to calculate OperatingProfits and Losses, which shall be shared by the Parties as provided in Article2.3(b).  In addition, the JCT orCollaboration Committee (as applicable) may, by unanimous agreement and [***][Confidential Treatment Required], allow some or all of any other overspend tobe included in the Reimbursable Commercial Costs as it considers equitable underthe circumstances.  Where

 

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any Commercialisation Budget sets out a line item estimate for the totalReimbursable Commercial Costs required to complete any activity which will notbe completed in that Contract Year:  (i)the budgeted costs and expenses for that activity shall [***] [ConfidentialTreatment Required] and (ii) any [***] [Confidential Treatment Required]against such line item estimate shall be [***] [Confidential TreatmentRequired] to the Commercialisation Budgets for [***] [Confidential TreatmentRequired] in each case as necessary to reflect any reasonable acceleration ordelay in such activity.  To the extentthat the overspend is not included in Reimbursable Commercial Costs as providedin this Article 6.8, the Party who has exceeded its budget by more than [***][Confidential Treatment Required] will be solely responsible for the overspend.

###  

## **6.9****                              ****Public Statements Regarding Antibody Product**

##  

Each Party shall be responsible fordisseminating accurate information regarding Antibody Products to its salesrepresentatives based on Product Labelling and Promotional Materials (and forcausing its Affiliates, sublicensees and Distributors to so disseminate suchaccurate information).  In exercisingtheir rights pursuant to this Article 6, UCB and ImClone shall seek to preventclaims or representations in respect of Antibody Products or thecharacteristics of Antibody Products (e.g., safety or efficacy) being made byor on behalf of it or its Affiliates, sublicensees or Distributors (by membersof its or their sales force or otherwise) which do not represent an accurate orfairly balanced summary or explanation of the Product Labelling of the AntibodyProducts in the country in question.

 

## **6.10****                       ****Medical and Other Inquiries**

##  

Each Party shall be responsible for respondingto all medical questions or inquiries relating to Antibody Products sold incountries for which it is the Territorial Lead. The Territorial Lead shall keep such records and make such reports as arereasonably necessary to document such communications in compliance with allApplicable Law.

 

## **6.11****                       ****Compliance with Laws**

##  

### (a)                                  Each Party shall,and shall procure that its Affiliates shall, comply with all Applicable Lawwith respect to the Commercialisation of Antibody Products.  Each Party shall, and shall procure that itsAffiliates shall, use [***] [Confidential Treatment Required] to, and shall use[***] [Confidential Treatment Required] to cause each of their respectiveemployees, representatives, sublicensees, Distributors and agents to, donothing which it knows or reasonably should know would jeopardise the goodwillor reputation of the other Party or any Antibody Product.

###  

### (b)                                 Notwithstandinganything in this Agreement to the contrary, neither Party shall be required toundertake any activity relating to the Commercialisation of Antibody Productsthat it believes, in good faith, may violate Applicable Law.

###  

### (c)                                  Each Party shall inall material respects conform its practices and procedures relating toeducating the medical community in the countries for which it is theTerritorial Lead with respect to Antibody Products to any applicable

 

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industry association regulations, policies and guidelines, as the samemay be amended from time to time, and shall comply with Applicable Law withrespect thereto.

###  

## **6.12****                       ****Promotional Materials and Activity**

##  

### (a)                                  Except with respectto Promotional Materials that are jointly developed by the Parties pursuant toArticle 6.4(a)(ii), each Party shall be responsible for preparing allPromotional Materials used to support an Antibody Product for an AgreedIndication for use in its Territory in consultation with the JCT.  All such Promotional Materials shall besubmitted to the JCT prior to use by either Party and prior to submission toany Regulatory Authority for regulatory approval (if such approval isrequired); *provided* that thecontent of Promotional Materials, once submitted, need not be submitted againprior to re-use unless the Product Labelling for such Antibody Product in suchAgreed Indication applicable to such Promotional Materials has been changedsince such prior submission date.  TheParties shall[***] [Confidential Treatment Required]Promotional Materialsprepared for use to support an Antibody Product for an Agreed Indication andthe Parties shall make such[***] [Confidential Treatment Required].  A Continuing Party with respect to anAntibody Product for an Independent Indication shall be responsible for preparingall Promotional Materials used to support such Antibody Product for suchIndependent Indication, in consultation with the JCT.  The development of all Promotional Materialsshall be consistent with the Commercialisation Plan and Applicable Law, and withthe approved Product Labelling.  Subjectto Article 5, the Filing Party for an Antibody Product for an Indication in acountry shall take the lead in obtaining any approvals from the RegulatoryAuthorities in such country required for the use of any Promotional Materialsfor such Indication in such country, and shall submit all applicablePromotional Materials for such Indication to the Regulatory Authorities in suchcountry as required by Applicable Law. For the avoidance of doubt, a Party shall not be required to re-submitany Promotional Materials to the JCT prior to use if the only changes made tosuch Promotional Materials since the original submission to the JCT are changesrequired by any Regulatory Authority. The Continuing Party with respect to an Antibody Product for anIndependent Indication shall [***] [Confidential Treatment Required] in anyPromotional Materials prepared by it or on its behalf for use to support suchAntibody Product for such Independent Indication.

###  

### (b)                                 All PromotionalMaterials, packaging and Product Labelling used by either Party in connectionwith Antibody Products in any country of the Territory shall contain (i) therelevant Product Trademarks, (ii) a UCB Company Mark (or a Trademark of a UCBAffiliate if directed by UCB) designated by UCB in the UCB Territory or anImClone Company Mark (or a Trademark of an ImClone Affiliate if directed byImClone) designated by ImClone in the ImClone Territory, and (iii) if requiredby Applicable Law, the logo and corporate name of the Manufacturer ((i) to(iii) collectively, the **Markings**).  To the extent possible, and subject to anyApplicable Law, the UCB Company Mark and the ImClone Company Mark (or anyTrademark of their respective Affiliates, as applicable) shall have equivalentprominence on all Promotional

 

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Materials, packaging and Product Labelling used by either Party inconnection with Antibody Products for Agreed Indications.  The manner in which the Markings are to bepresented on Promotional Materials, packaging and Product Labelling forAntibody Products shall be subject to prior review and approval by (A) UCB withrespect to a UCB Company Mark under paragraphs (ii) and, if applicable, (iii)above and ImClone with respect to an ImClone Company Mark under paragraphs (ii)and, if applicable, (iii) above, and (B) the JCT with respect to the Markingsunder paragraph (i) above.

###  

### (c)                                  Prior to the use ofany of them, each Territorial Lead shall provide to the other Party, through theJCT, a prototype of any Promotional Materials, packaging or Product Labellingfor Antibody Products for the purposes of the other Party’s review of themanner in which its Corporate Mark and any Product Trademark is used on any ofthe same.  The reviewing Party shallnotify the other Party within [***] [Confidential Treatment Required] afterdelivery of such prototype, whether the reviewing Party approves or disapprovesof the manner of such use and, in the case of disapproval, the specific reasonsfor such disapproval and an acceptable alternative.  In the event the reviewing Party fails to sonotify the other Party within such [***] [Confidential Treatment Required]period, the reviewing Party shall be deemed to have approved of the manner ofsuch use.  In the event the reviewingParty disapproves of the manner of such use and the Parties are unable to reachagreement regarding the manner of such use, such dispute shall be resolved bythe Parties in accordance with Article 15, *provided*[***] [Confidential Treatment Required].

###  

### (d)                                 Each Party shallpermit one or more authorised representatives of the other Party, on reasonableprior notice, at reasonable intervals, during normal business hours to inspectand examine from time to time Promotional Materials, packaging and ProductLabelling for Antibody Products and the use of such Promotional Materials,packaging or Product Labelling.

###  

### (e)                                  Each Party shallinstruct its sales representatives to and shall use [***] [ConfidentialTreatment Required] to train and monitor its sales representatives for AntibodyProducts so that such sales representatives, (i) use only Promotional Materials(without any addition, deletion or other modification) approved for use underthis Article 6.12 for the Promotion of such Antibody Products, (ii) limitclaims of efficacy and safety for any such Antibody Products to those that areconsistent with Applicable Law and with approved (by the appropriate RegulatoryAuthority) promotional claims in Product Labelling and such Promotional Materials,and not add, delete or otherwise modify claims of efficacy and safety in thePromotion of such Antibody Products in any respect from those claims ofefficacy and safety that are contained in such approved Product Labelling andPromotional Materials, and (iii) Commercialise such Antibody Products inadherence with Applicable Law.

###  

## **6.13****                       ****Post-Regulatory Approval Activities**

##  

Subject to Articles 2.1, 3.7 and 6.11, eachParty shall have the right to conduct Post-Approval Studies, including studiesin support of Compendia Listings, for Antibody

 

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Products anywhere in the Territory.  The JCT shall coordinate all Post-ApprovalStudies for Antibody Products and shall have the opportunity to review andcomment on any proposed Post-Approval Study for Antibody Products before itsimplementation.  In addition, before theimplementation of the relevant Post-Approval Study, the JDT shall have theopportunity to review all designs and protocols for Post-Approval Studies insupport of Compendia Listings for Antibody Products that have been submitted byeither Party pursuant to Article 4.7(e) and shall refer such protocols to theCollaboration Committee (which shall also have the opportunity to review suchprotocols before the implementation of the relevant Post-Approval Study).

 

## **6.14****                       ****Product Trademarks**

##  

Subject to Article 6.12, each Party shallCommercialise Antibody Products solely under the applicable Product Trademarks.

 

## **6.15****                       ****ImClone Royalties**

##  

### (a)                                  In partial considerationof the licence rights granted by ImClone to UCB hereunder, UCB shall pay toImClone royalties on the terms and conditions set forth in this Article 6.15and Article 2.3, which payments shall not be used to calculate OperatingProfits or Losses.

###  

### (b)                                 Subject to Article6.15(c), UCB shall pay to ImClone royalties on all Net Sales of AntibodyProducts (except sales of Antibody Product for an Independent Indication duringthe applicable Royalty Term by the Continuing Party or its Affiliates or theirrespective Distributors or sublicensees in those countries for which suchContinuing Party is the Territorial Lead) sold by either Party, theirAffiliates or their respective Distributors or sublicensees in the Territory ata royalty rate equal to [***] [Confidential Treatment Required] (the **ImClone Royalties**).

###  

### (c)                                  ImClone’s right toreceive ImClone Royalties under this Article 6.15 shall commence in eachcountry in the Territory on the date of [***] [Confidential TreatmentRequired](the **Royalty Term**).

###  

### (d)                                 Any ImCloneRoyalties payable by UCB under this Article 6.15, together with any priorImClone Royalties deferred by operation of this sentence, that [***][Confidential Treatment Required] Nothing in this Article 6.15(d) is intended or shall be construed torelieve UCB of its obligations to pay ImClone Royalties under this Article6.15.

###  

### (e)                                  For clarity, anyroyalties payable under the ImClone In-Licences (including the [***][Confidential Treatment Required]) shall [***] [Confidential TreatmentRequired]

###  

# **7.****                                     ****MANUFACTURE AND SUPPLY**

# ** **

## **7.1****                              ****Establishment of Joint Manufacturing Team**

##  

Within [***] [Confidential Treatment Required]after the Effective Date, the Parties shall form a Joint Manufacturing Team(JMT).  Each member of the JMT shall haveoperational experience in the Manufacture of Antibodies.  The JMT shall consist of up

 

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to [***] [Confidential Treatment Required]representatives of each Party.  One suchrepresentative from each Party shall be designated as that Party’s **Manufacturing Team Leader** to act as theprimary JMT contact for that Party. Together, the Manufacturing Team Leaders will be jointly responsible formanaging the JMT.  Either Party mayreplace any or all of its representatives at any time upon written notice tothe other Party.  Any member of the JMTmay designate a substitute to attend and perform the functions of that memberat any meeting of the JMT.  Each Partymay invite (at its discretion with the consent of the other Party[***] [ConfidentialTreatment Required]) additional employees or consultants to attend the JMTmeetings.  The JMT shall be empowered tocreate such sub-teams or subcommittees as it may deem appropriate or necessary.  Each such sub-team or subcommittee shallreport to the JMT, which shall have authority to approve or rejectrecommendations or actions proposed, subject to the terms of thisAgreement.  No sub-team or subcommitteeshall have authority to make any decision binding upon the JMT or theParties.  The JMT shall meet, at leastonce each Calendar Quarter, or more frequently, as agreed by the JMT.  To the extent that meetings are held inperson, the location of JMT meetings shall alternate between the offices of theParties unless otherwise agreed. Meetings shall be chaired by a single JMT representative of one of theParties, with the Party responsible for designating the chairperson alternatingeach Contract Year and with UCB responsible for designating the chairperson forthe First Contract Year.  Meetings may beheld by videoconference or telephonically. The Party that does not provide the chairperson shall designate a memberof the JMT to record, in sufficient detail, minutes of the discussions anddecisions of the JMT.  Such minutes shallbe circulated to the Parties promptly following the meeting for review, commentand, after approval from [***] [Confidential Treatment Required],distribution.  The Parties shallendeavour to manage the business and meetings of the JMT in the mostcost-effective way possible.

 

## **7.2****                              ****JMT Responsibilities**

##  

The JMT shall have the followingresponsibilities:

 

### (a)                                  for each AntibodyProduct, developing, for approval by the Collaboration Committee, a detailedplan and budget for the Manufacture and supply of that Antibody Product (the **Manufacturing Plan**), including targets forcost of goods, forecast mechanisms, scale-up strategies, Manufacturingtechnologies to be employed and strategies for supply chain continuityincluding, where applicable, back-up Manufacturing facilities;

###  

### (b)                                 for each AntibodyProduct, selecting the Party that will coordinate the Manufacture and supply ofthat Antibody Product (the **ManufacturingCoordinator**);

###  

### (c)                                  for each AntibodyProduct, selecting the Party(ies) or Third Party(ies) that will be responsiblefor Manufacturing and supplying such Antibody Product or any intermediatethereof (each Party or Third Party so selected being a **Manufacturer,**which term shall also includeany Third Party supplier under the supply agreements listed in Schedule 4).  In choosing the Manufacturer(s), the JMTshall select the Party(ies) or Third Party(ies) that are likely to be best ableto meet Clinical Supply and/or Commercial Supply requirements for Antibody

 

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Products and offer a competitive manufacturingsolution based on the following criteria:

###  

[***] [ConfidentialTreatment Required]

 

Unless otherwise agreed by the Parties,potential Manufacturers (including either of the Parties if they wish to beappointed Manufacturer) shall be required to prepare detailed submissions(either as part of a competitive tender or such other procedure as may beagreed by the JMT) addressing these requirements for review by the JMT.  Any member of the JMT may require any of thepotential Manufacturers to answer additional due diligence questions.  Such submissions and due diligence shall bereviewed and discussed by the JMT before any decision as to the identity of anyManufacturer is taken by the JMT;

 

### (d)                                 [***] [ConfidentialTreatment Required], approving (i) the terms on which any Manufacturer (whethera Party or a Third Party) is appointed to provide Clinical Supplies and/orCommercial Supplies and (ii) any agreements with respect thereto (each a **Manufacturing Agreement**);

###  

### (e)                                  approving anyamendment or modification to, or waiver under (i) any Manufacturing Agreementor (ii) any of the supply agreements listed in Schedule 4 in existence on theEffective Date to the extent that such amendment, modification or waiverrelates to Antibody Products;

###  

### (f)                                    approving the useof any new Manufacturing Know-How that will be used in the Manufacture ofAntibody Products;

###  

### (g)                                 agreeing on theformulation of Antibody Products and the specifications for the Manufacture ofAntibody Products including the processes for production, purification andtesting (including quality control and assurance testing procedures) for suchAntibody Products (collectively, **the AntibodyProduct Specifications**);

###  

### (h)                                 consulting with theJCT and with the JDT, as applicable, to assist the JCT and JDT in identifyingmanufacturing needs and requirements of Clinical Supplies (including placeboand comparators) and Commercial Supplies of Antibody Products and, togetherwith the JDT and JCT, developing and implementing an appropriate forecastingmechanism to provide any Manufacturer(s) with sufficient lead-time toManufacture or have Manufactured the Parties’ requirements of Clinical Supplies(including placebo and comparators) and Commercial Supplies of AntibodyProducts;

###  

### (i)                                     coordinating withthe JDT and JCT to approve rationing plans for Antibody Product in the event ofscarcity of supply in accordance with Article 7.10;

###  

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### (j)                                     in consultationwith the JCT and JDT, as applicable, periodically review and, as necessary,revise the forecasting and order mechanisms to ensure the continuity andadequacy of Clinical Supplies and Commercial Supplies of Antibody Products;

###  

### (k)                                  determining whetheror not the Parties, or if applicable the Manufacturing Coordinator, should takeaction to enforce their or its rights against a Third Party supplier ofAntibody Products and if so, making all decisions relating to the conduct ofsuch action;

###  

### (l)                                     periodically, but,unless otherwise agreed by the Parties, no less frequently than every [***][Confidential Treatment Required], reassessing using the process set forth inArticle 7.2(c) above whether the existing Manufacturer(s) of Antibody Productscontinue to offer a competitive Manufacturing solution and, if not, selectingnew or additional Manufacturers or amend the Manufacturing Agreement(s) withthe existing Manufacturer(s) to include such competitive terms, as provided inArticle 7.2(a) through (e) above; and

###  

### (m)                               agreeing whetherany of the****Third Party suppliersunder the supply agreements listed in Schedule 4 shall be requested toManufacture Antibody [***] [Confidential Treatment Required]

###  

The JMT shall also be responsible for all otheractivities assigned to it by the Collaboration Committee and shall provide theCollaboration Committee with Quarterly reports of its activities.

 

## **7.3****                              ****Joint Manufacturing Team Decision-Making**

##  

Decisions of the JMT shall be made by unanimousvote of the Manufacturing Team Leaders. If the JMT is unable to resolve a dispute regarding any issue, thematter shall be resolved pursuant to the dispute resolution process set forthin Article 15, provided that if (i) any dispute relating to the selection of aManufacturer or the terms of any Manufacturing Agreement has not been resolvedfollowing referral to the Parties’ respective Chief Executive Officers inaccordance with the dispute resolution process, or (ii) there is a materialissue with respect to the quality or sufficiency of supplies of AntibodyProduct pursuant to any Manufacturing Agreement and the Parties are unable toagree how to resolve such issue within [***] [Confidential Treatment Required]from the date one Party notifies the other that a material issue has arisen,notwithstanding any other provision in this Agreement to the contrary, eachParty shall be immediately entitled to make its own arrangements for therelevant supply of Antibody Products for Phase III Clinical Studies or inrespect of Commercialisation of Antibody Products in the countries for which itis the Territorial Lead in which event Article 7.12 shall apply.

 

## **7.4****                              ****Role of the Manufacturing Coordinator**

##  

### (a)                                  The ManufacturingCoordinator shall:

###  

#### (i)                                     be responsible forthe day to day implementation of the Manufacturing Plan and administration ofManufacturing-related activities;

 

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#### (ii)                                  provide advice tothe JDT and JCT on provisions in the Development Plan and CommercialisationPlan, respectively, that relate to the supply of Antibody Products to the Parties;

####  

#### (iii)                               consult with theJCT and JDT, as applicable, and assist the JCT and JDT in identifyingManufacturing needs and requirements of Clinical Supplies (including placeboand comparators) and Commercial Supplies of Antibody Products;

####  

#### (iv)                              provide assistanceto the JMT in connection with the development and implementation of anappropriate forecasting mechanism to provide any Manufacturer(s) withsufficient lead-time to Manufacture or have Manufactured the Parties’requirements of Clinical Supplies (including placebo and comparators) andCommercial Supplies of Antibody Products;

####  

#### (v)                                 based on thecriteria set out in Article 7.2(c) and when and in the form requested by theJMT, provide the JMT with details of Third Parties capable of Manufacturingeach Antibody Product and provide such additional assistance as the JMT mayrequire in connection with verifying such capability and otherwise assessingproposals submitted by such Third Parties;

####  

#### (vi)                              at the JMT’srequest and in accordance with the JMT’s instructions, negotiate on behalf ofthe Parties the terms of a draft Manufacturing Agreement with such Third Partyto be submitted and reviewed by the JMT, *provided*that the Party that is not the Manufacturing Coordinator shall have the rightto participate and have an equal voice in any such negotiation, and *provided, further*, that if the JMT selectsthe Manufacturing Coordinator to act as Manufacturer for any Antibody Productthe other Party shall negotiate the terms of such Manufacturing Agreement withthe Manufacturing Coordinator;

####  

#### (vii)                           use [***][Confidential Treatment Required] to ensure that any draft ManufacturingAgreement submitted to the JMT for approval complies with Article 7.8 and drawto the JMT’s attention any aspect of any draft Manufacturing Agreement thatdoes not comply with Article 7.8;

####  

#### (viii)                        supervise the performance ofany Third Party Manufacturer and report any breaches of the ManufacturingAgreement to the JMT;

####  

#### (ix)                                provide anyadministrative assistance required by the JMT in connection with theperformance of the Manufacturing Agreement, including compilation of forecastsand submission of orders;

####  

#### (x)                                   take such action asthe JMT directs to enforce the Parties’ rights, for the benefit of bothParties, against Third Party Manufacturers. Costs and recoveries of any such enforcement action by the ManufacturingCoordinator shall be treated in accordance with Article 7.9;

####  

#### (xi)                                have theresponsibilities set out in Article 7.5(b); and

 

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#### (xii)                             provide such otherassistance as the JMT may reasonably request.

####  

### (b)                                 The ManufacturingCoordinator shall ensure that the Manufacture of Antibody Products does notdeviate from the agreed Manufacturing Plan in any material respect, unless ithas obtained the JMT’s prior written consent to such material deviation [***][Confidential Treatment Required]; *provided,**however* that, where time does notpermit, the Manufacturing Coordinator may deviate from the agreed ManufacturingPlan with the prior written consent of the other Party’s Manufacturing TeamLeader [***] [Confidential Treatment Required]. Where the Party that is not theManufacturing Coordinator’s Manufacturing Team Leader consents to a deviationfrom the agreed Manufacturing Plan in accordance with this Article 7.4(b), theManufacturing Coordinator shall promptly brief the JMT on the reasons for thedeviation and on the course of action pursued.

###  

### (c)                                  The ManufacturingCoordinator shall have the responsibilities set out or referred to in this Article7.4 but shall not be responsible for any other activities unless assigned to itby the JMT and shall provide the JMT with detailed reports of its activitiesmonthly within [***] [Confidential Treatment Required] of the end of therelevant calendar month or at such intervals as the JMT may agree.

###  

## **7.5****                              ****Regulatory Approvals**

##  

### (a)                                  Without prejudiceto Article 5, if a Party is the Manufacturer, such Party shall be responsiblefor obtaining all necessary Regulatory Approvals to perform its obligationsunder this Article 7 and the Manufacturing Agreement and shall (i) provide theother Party with all chemistry, manufacturing and controls data and such otherdata and information with respect to the manufacture, holding, shipment andtesting of such Antibody Product (or a drug master file or equivalent outsidethe United States containing the same) as are required by cGMP and otherApplicable Law or that are otherwise necessary for each Territorial Lead toobtain and maintain all INDs, Drug Approval Applications and RegulatoryApprovals for the sale and use of such Antibody Product in each country inrespect of which it is the Territorial Lead; and (ii) grant to the other Partya right of access and reference to all Regulatory Approvals or other governmentlicences, approvals or certificates relating to the Manufacture of an AntibodyProduct and any drug master file relating to an Antibody Product.

###  

### (b)                                 Without prejudiceto Article 5, if a Third Party is the Manufacturer, the ManufacturingCoordinator shall be responsible for ensuring that the Manufacturer:

###  

#### (i)                                     obtains allnecessary Regulatory Approvals to perform its obligations under theManufacturing Agreement or any of the agreements listed in Schedule 4;

####  

#### (ii)                                  provides each Partywith all chemistry, manufacturing and controls data and such other data andinformation with respect to the manufacture, holding, shipment and testing ofsuch Antibody Product (or a drug master file or equivalent outside the UnitedStates containing the same) as are required by cGMP and other Applicable Law orare otherwise necessary

 

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for each Territorial Lead to obtain andmaintain all INDs, Drug Approval Applications and Regulatory Approvals for thesale and use of such Antibody Product in each country in respect of which it isthe Territorial Lead; and

####  

#### (iii)                               grants to eachParty a right of access and reference to all Regulatory Approvals or othergovernment licences, approvals or certificates relating to the Manufacture ofan Antibody Product and any drug master file relating to an Antibody Product.

####  

## **7.6****                              ****Transfer Price**

##  

The Transfer Price for Antibody Product shallbe calculated as defined in Schedule 2.

 

## **7.7****                              ****Manufacturing**

##  

### (a)                                  The Parties agreethat Clinical Supplies of CDP-791 required for Development through [***][Confidential Treatment Required].  If atany time UCB becomes aware that these[***] [Confidential Treatment Required]will not be sufficient to meet such Development supply needs, it shall promptlynotify the JMT.  For the avoidance ofdoubt, the Parties expressly acknowledge that these [***] [ConfidentialTreatment Required].

###  

### (b)                                 Unless otherwiseagreed by the Parties, any Manufacturing Agreement (with a Party or a ThirdParty), shall include the terms set out in Article 7.8 and such other terms asthe JMT considers necessary or appropriate in the circumstances.

###  

### (c)                                  If the JMT selectsa Third Party to be the Manufacturer of Antibody Product, that Third Party andboth ImClone and UCB shall be parties to the Manufacturing Agreement unlessthat would be impracticable or UCB or ImClone, as the case may be, elects notto be a party.

###  

### (d)                                 Each Party shallcomply and operate in accordance with the terms of any Manufacturing Agreementand [***] [Confidential Treatment Required] to which it is a party if and tothe extent that such agreements relate to the supply of Antibody Product up toand including [***] [Confidential Treatment Required]; *provided*, *however*,that nothing shall require either Party to take any action in violation ofApplicable Law or refrain from taking any action if to do so would put it inviolation of Applicable Law.

###  

### (e)                                  Without prejudiceto UCB’s obligations pursuant to Article 4.1(a), UCB shall as soon aspracticable following the Effective Date and in any event within [***][Confidential Treatment Required] following the Effective Date, transfer inaggregate [***] [Confidential Treatment Required] of master cell bank forCDP-791 to one or more escrow agent(s). ImClone shall select the proposed escrow agent(s) and, subject to UCB’sprior approval of the escrow agent so selected [***] [Confidential TreatmentRequired] ImClone shall appoint the escrow agent(s).  Subject to Article 7.7(f), pendingrelease of all the vials to UCB or ImClone as set out in this Article 7.7(e),UCB shall procure that there are in aggregate [***] [Confidential TreatmentRequired] of master cell bank for CDP-791 in escrow with the appointed escrowagent(s) at all times.  The costs

 

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incurred by the Parties in connection with theappointment and services of the first escrow agent and any replacement(s) tothe first escrow agent agreed by the Parties shall be Other Out of PocketExpenses.  If, at ImClone’s discretion,more than one escrow agent is appointed at any one time, the costs incurred inconnection with the appointment and services of any such additional escrowagent(s) shall be borne by ImClone.  Theescrow agent(s) shall hold such vials on terms requiring that such vials shallbe released to ImClone (or as it may direct) at ImClone’s request *provided* that, subject to Article 7.7(f),ImClone may only request such release if:

###  

#### (i)                                     the Parties areentitled to make their own arrangements for Manufacture of Antibody Product inaccordance with Article 7.3; or

####  

#### (ii)                                  this Agreement isterminated in accordance with Article 12 and ImClone is or will be theRemaining Party, such transfer to be effected promptly following notice oftermination.

####  

On termination of this Agreement in accordancewith Article 12 where UCB is the Remaining Party, ImClone shall instruct allescrow agent(s) holding any vials of master cell bank for CDP-791 to returnsuch vials to UCB.

 

### (f)                                    At any time duringthe Term while vials of master cell bank for CDP-791 are held in escrow,ImClone shall, at UCB’s request, instruct the escrow agent(s) to release up toan aggregate of [***] [Confidential Treatment Required] to UCB.  Following any such release, UCB shalltransfer the same number of vials of master cell bank for CDP-791 back to thereleasing escrow agent(s) as soon as reasonably practicable.

###  

### (g)                                 At any time afterrelease of the vials from escrow to ImClone in accordance with Article 7.7(e),UCB shall, at ImClone’s request, transfer to ImClone up to [***] [ConfidentialTreatment Required]of master cell bank for CDP-791.  Following any such transfer, ImClone shalltransfer the same number of vials of master cell bank for CDP-791 back to UCBas soon as reasonably practicable.

###  

**7.8****                              ****Manufacturing Terms**

##  

### (a)                                  The ManufacturingAgreement shall provide sufficient time for renewal or termination to enablethe Parties to identify and qualify a suitable substitute Manufacturer that isable to meet the Parties’ Clinical Supply and Commercial Supply requirements,as applicable.  The ManufacturingAgreement shall provide for appropriate strategies to ensure the continuity ofsupply, including inventory management plans and, where [***] [ConfidentialTreatment Required], qualified back-up manufacturing facilities.  The Manufacturer shall (i) transfer allInformation and Materials, including any proprietary know-how and any researchand master cell banks, and provide such technical assistance, and (ii) provideany rights and licences, including any rights of reference to any Regulatory Approvalsand licences to any Patent Rights controlled by the Manufacturer, in each case((i) and (ii)) to any substitute and back-up Manufacturers designated by theJMT or, in the case of a breach of a Manufacturing Agreement by a PartyManufacturer, the other Party, as [***]

 

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[Confidential Treatment Required] for suchsubstitute or back-up Manufacturer to Manufacture the applicable AntibodyProducts.

###  

### (b)                                 Each Party shallhave a licence and right to use and reference any Manufacturing-relatedInformation, inventions or Materials characterised, conceived, developed,derived, discovered, generated, identified or otherwise made by any employee,consultant or agent of the Manufacturer in connection with any Manufacturingactivities conducted under a Manufacturing Agreement or the existing supplyagreements listed in Schedule 4 (**ManufacturingKnow How**) and any Patent rights with respect thereto (**Manufacturing Patents**) to Develop,Commercialise, Manufacture, make, have made, use, sell, have sold, offer tosell or resell, import, export, distribute or otherwise transfer physicalpossession of or otherwise transfer title in or to Antibody Products.

###  

### (c)                                  The Manufacturershall be required to obtain and maintain all Regulatory Approvals relating tothe Manufacture of Antibody Product and grant access and rights of reference toall such Regulatory Approvals and drug master files and other data as set forthin Article 7.5.

###  

### (d)                                 The Manufacturershall manufacture Antibody Products in facilities described in the applicableRegulatory Approvals in accordance with (i) the Antibody ProductSpecifications, (ii) GMP and all other Applicable Law, and (iii) the terms ofthe applicable Manufacturing Agreement ((i)-(iii) collectively, the **Antibody Product Standards**).

###  

### (e)                                  The terms of theManufacturing Agreement shall be consistent with and provide for theManufacture of Antibody Products as required and anticipated by this Agreement.

###  

### (f)                                    The Manufacturershall not manufacture for, or sell, licence, or distribute Antibody Productsto, any person or entity other than the Parties, their Affiliates or, if it hasreceived the relevant Party’s consent, a Party’s permitted sublicensees orDistributors.

###  

### (g)                                 The ManufacturingAgreement shall include a forecasting and order mechanism consistent with theprocedures adopted by the JDT, JCT and JMT pursuant to Articles 4.6(b)(viii),6.5(a)(ii) and 7.2(a) that is designed to ensure that the Manufacturer is ableto meet the Parties’ clinical and commercial requirements on a timely basis,which shall provide adequate flexibility to meet unexpected demand, or the lackthereof, particularly around launch.

###  

### (h)                                 Manufacturer shallguarantee, at the time of delivery, that Antibody Products supplied by it (i)have been manufactured, packaged, held and shipped in accordance with theAntibody Product Standards and all other Applicable Law; (ii) are notadulterated or misbranded under the FFDCA, or under any other Applicable Law;(iii) may be introduced into interstate commerce pursuant to the FFDCA; and(iv) that the processes, procedures and materials used in the manufacture ofsuch Antibody Products do not and will not infringe the intellectual propertyor other proprietary rights of a Third Party. Manufacturer shall also warrant and covenant that Manufacturer has notbeen debarred and is not subject to debarment and will not use in any capacity,in connection with the

 

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services to be performed under the ManufacturingAgreement, any person who has been debarred pursuant to section 306 of theFFDCA, 21 U.S.C. § 335a, or who is the subject of a conviction described insuch section (or under any analogous provisions of Applicable Law outside theUnited States).

###  

### (i)                                     Manufacturer shalldefend, indemnify and hold the Parties, their Affiliates and their respectiveofficers, directors, employees, agents and designees harmless from any and alllosses, damages, liabilities, costs and expenses (including [***] [ConfidentialTreatment Required] attorneys fees and other costs of defence), in connectionwith any and all actions, suits, claims, demands or judgments that may bebrought or instituted against any of them by any Third Party to the extent thatany such losses, damages, liabilities, costs and expenses arise out of, orresult from, any [***] [Confidential Treatment Required]

###  

### (j)                                     The Parties shallhave the right (upon reasonable notice and during reasonable business hours) toobserve, audit and inspect the facility or the manufacturing process used inthe Manufacture of each Antibody Product, and Manufacturer will allow arepresentative of the Parties (or, with respect to a Party Manufacturer, arepresentative of the other Party) reasonable access to all Manufacturingrecords for each such Antibody Product, so as to verify that Manufacturer is incompliance with the Antibody Product Standards and all other ApplicableLaw.  Manufacturer shall use [***][Confidential Treatment Required] to correct any material non-compliance withthe Antibody Product Standards or other Applicable Laws that is discovered andbrought to its attention as a result of such inspections. If only one Partyconducts such audit, the results shall be provided to the other Party.

###  

### (k)                                  If a Party is theManufacturer, the other Party shall have the right to audit Manufacturer’srecords relating to the calculation of the COGM and the Transfer Price inaccordance with Article 2.3(j).

###  

## **7.9****                              ****Costs**

##  

To the extent relating to Antibody Product,except relating to a Party in its capacity as Manufacturer (which shall begoverned by Schedule 2 and the applicable Manufacturing Agreement), all [***][Confidential Treatment Required] including: [***] [Confidential TreatmentRequired] shall be Development Costs if incurred for Development and Other Outof Pocket Costs if incurred for Commercialisation, and all amounts recoveredfrom any Third Party supplier shall be deemed to be Gross Receipts, *provided*, *however*,that if the [***] [Confidential Treatment Required] and *provided further* that any such[***][Confidential Treatment Required].

 

## **7.10****                       ****Scarcity of Supply**

##  

If, at any time during the Term, there is aninsufficient supply of Antibody Products to meet both Parties’ needs forClinical Supplies and/or Commercial Supplies of that Antibody Product, the JMTshall, in coordination with the JDT and/or JCT (as appropriate), allocate theavailable Clinical Supplies and/or Commercial Supplies (as appropriate) of thatAntibody Product to the Parties [***] [Confidential Treatment Required] and(ii) the goal of maximising the long term value of that Antibody Product forboth Parties.

 

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## **7.11****                       ****Shared Risk of Third Party Suppliers**

##  

Each Party acknowledges that, save with respectto any Third Party supplier with whom a Party has made its own arrangements forthe supply of Antibody Products pursuant to Article 7.3, the risk of nonperformance by a Third Party supplier that Manufactures any Antibody Product isa risk equally shared by them and that neither Party is responsible or liablefor any act or omission of any such Third Party supplier (other than an act oromission to the extent caused by [***] [Confidential Treatment Required].

 

## **7.12****                       ****Independent Manufacture**

##  

If the Parties elect to make their ownarrangements for the Manufacture of Antibody in accordance with Article 7.3:

 

### (a)                                  each Party shallprovide [***] [Confidential Treatment Required] such assistance (includingproviding prompt access to all ImClone Know How (in the case of ImClone), UCBKnow How (in the case of UCB) and Manufacturing Know How and rights ofreference to any Regulatory Approvals) as may be reasonably required by theother Party to Manufacture or have Manufactured Antibody Product;

###  

### (b)                                 the provisions ofthis Article 7 shall continue to apply in relation to Manufacturing activitiesrelating to supplies of Antibody Product for Phase I Clinical Studies and PhaseII Clinical Studies;

###  

### (c)                                  subject to Article7.12(b), the responsibilities of the JMT shall be restricted to those set outin Article 7.2(f) and (g) and unless the Parties otherwise agree there shall beno Manufacturing Coordinator;

###  

### (d)                                 each Party shalluse [***] [Confidential Treatment Required] to secure a competitivemanufacturing solution based on the criteria set out in Article 7.2(c) andshall consider such criteria in good faith when deciding whether to ManufactureAntibody Product itself and when selecting any Third Party to ManufactureAntibody Product;

###  

### (e)                                  each Party shalluse [***] [Confidential Treatment Required] to ensure that Antibody Product isManufactured in accordance with Article 7 as modified by this Article 7.12 andthe terms of any agreement it enters into with a Third Party for theManufacture of Antibody Product shall comply with Article 7.8 (to the extentapplicable when only one Party is a party to any such agreement) and shall alsouse [***] [Confidential Treatment Required] to ensure that any such agreementallows the assignment of such agreement to the Remaining Party on terminationof this Agreement;

###  

### (f)                                    Article 7.5 shallcontinue to apply except that for the purposes of Article 7.5(b) each Partyshall assume the responsibilities of the Manufacturing Coordinator with respectto any Third Party Manufacturer appointed by it;

###  

### (g)                                 each Party shall beresponsible for the Transfer Price of Antibody Product Manufactured by or onbehalf of that Party pursuant to this Article 7.12 and

 

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such costs shall not be included in thecalculation of Operating Profits and Losses; and

###  

### (h)                                 subject to Article7.12(b), Article 7.10 shall not apply.

###  

## **7.13****                       ****Manufacturing Cost Allocation**

##  

### (a)                                  If, as a result of any provision in anyof the existing supply agreements listed in Schedule 4, UCB or any of itsAffiliates is contractually obliged to use one of the Third Party supplierspursuant to that supply agreement for the supply of Antibody Products for anyPhase III Clinical Study or in respect of the Commercialisation of AntibodyProducts (the **Relevant Supply**),UCB agrees that, notwithstanding anything to the contrary in this Agreement,UCB shall be solely responsible for the Additional Manufacturing Amount and UCBshall reimburse ImClone with respect to the Additional Manufacturing Amountthrough adjustments to the Operating Statement.

###  

### (b)                                 For the purposes of Article 7.13(a) andSchedule 2, **Additional Manufacturing Amount**shallmean the amount, if any, by which:

###  

#### (i)                                     [***] [ConfidentialTreatment Required]

####  

#### (ii)                                  [***] [ConfidentialTreatment Required]

####  

# **8.****                                     ****INDEPENDENT INDICATIONS**

# ** **

## **8.1****                              ****Designation of Independent Indications**

##  

Each Party shall have the right at any time, onwritten notice to the other Party, with respect to each Agreed Indication foran Antibody Product to terminate its rights and obligations to continue toDevelop and Commercialise such Antibody Product for such Agreed Indication(which Indication shall become an **IndependentIndication**, unless and until it is Converted pursuant to Article8.9), whereupon, except as otherwise provided in this Article 8, such Party(which Party shall be referred to herein as the **Non-Continuing Party**, and the other Party, the **Continuing Party**, with respect to suchIndependent Indication for such Antibody Product):

 

### (a)                                  shall cease to haveany right or, except as provided in Article 4.3(b), obligation to fund orparticipate in the Development of such Antibody Product for such IndependentIndication in the Territory;

###  

### (b)                                 shall not have theright to seek (including by filing a Drug Approval Application), obtain or maintainany Regulatory Approvals for such Antibody Product for such IndependentIndication in the Territory; and

###  

### (c)                                  shall have no rightor obligation to share in any Operating Profits and Losses of the ContinuingParty with respect to such Antibody Product for such Independent Indication inthe countries for which the Continuing Party is the Territorial Lead except asprovided in Article 8.2(b) and 8.9 and, if the Non-Continuing Party is theManufacturer of such Antibody Product, pursuant to the applicable ManufacturingAgreement.

 

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If, at any time, both Parties have exercisedtheir rights under this Article 8.1 with respect to an Agreed Indication, theParties shall cease all Development activities with respect to that AgreedIndication as expeditiously and as cost effectively as possible with due regardfor patient safety and the rights of any subjects that are participants inClinical Studies or Post-Approval Studies and in compliance with Applicable Law.  All disputes regarding IndependentIndications shall be resolved pursuant to Article 15.

 

## **8.2****                              ****Continuing Party’s Rights and Obligations with respect to anIndependent Indication**

##  

### (a)                                  Subject to Article8.3, the Continuing Party with respect to an Antibody Product for anIndependent Indication shall have the right to (i) conduct Development andPost-Approval Studies of such Antibody Product for such Independent Indicationthroughout the Territory, and the Non-Continuing Party shall assist theContinuing Party with respect thereto pursuant to Article 8.8, and (ii) prepareand file any Drug Approval Application, and obtain and maintain any RegulatoryApprovals, for such Antibody Product for such Independent Indication in thecountries for which it is the Territorial Lead and (iii) Commercialise suchAntibody Product for such Independent Indication in the countries for which itis the Territorial Lead.  For clarity,the foregoing does not permit the Continuing Party with respect to an AntibodyProduct for an Independent Indication to Commercialise (other than to conductPost-Approval Studies for) such Antibody Product for such IndependentIndication in the countries for which the Non-Continuing Party is theTerritorial Lead.

###  

### (b)                                 The ContinuingParty with respect to an Antibody Product for an Independent Indication shallpay to the Non-Continuing Party royalties on the Net Sales of such AntibodyProduct for such Independent Indication, sold by the Continuing Party, itsAffiliates or their respective sublicensees or Distributors in the countriesfor which the Continuing Party is the Territorial Lead (the **Relevant Net Sales**) as follows:

###  

[***] [ConfidentialTreatment Required]

 

### (c)                                  [***] [ConfidentialTreatment Required]

###  

### (d)                                 Article 2.3 shallapply to all royalties due and owing under the provisions of this Article 8.2.

###  

## **8.3****                              ****Consultation with the JDT and Collaboration Committee**

##  

The Continuing Party, with respect to anAntibody Product for an Independent Indication, shall consult regularly withthe JDT and consider in good faith the input of

 

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the JDT with respect to any decision or actionrelated to the Development of such Antibody Product for such IndependentIndication to the extent such decision or action could [***] [ConfidentialTreatment Required] affect the Development of an Antibody Product for an AgreedIndication or either Party’s ability to obtain and maintain Regulatory Approvalfor an Antibody Product for an Agreed Indication or could give rise to materialsafety concerns or other issues that might materially and adversely affect theDevelopment or Commercialisation of an Antibody Product for an AgreedIndication.  In particular, theContinuing Party shall submit all designs and protocols for Clinical Studiesfor an Antibody Product for an Independent Indication to the JDT for review andthe Continuing Party shall not, unless otherwise agreed by the CollaborationCommittee, commence any such Clinical Study less than [***] [ConfidentialTreatment Required] after such submission. Further, the Continuing Party with respect to an Antibody Product for anIndependent Indication, shall provide to the Collaboration Committee, for itsreview and comment, but not approval:

 

### (a)                                  within [***][Confidential Treatment Required]of any conversion of an Agreed Indication foran Antibody Product to an Independent Indication in accordance with Article 8.1or adoption of a new Indication as an Independent Indication in accordance withArticle 4.7(d) and thereafter at least [***] [Confidential Treatment Required]prior to the start of each subsequent Contract Year, a plan setting out inreasonable detail its proposed Development activities with respect to thatAntibody Product for the remainder of the Contract Year in which the conversionor adoption occurs or the forthcoming Contract Year (as appropriate) such planto be attached to, but not form part of, the Development Plan;

###  

### (b)                                 upon the completionof a Clinical Study, a summary of the Clinical Study results and any resultantdata analyses;

###  

### (c)                                  the annual reportswith respect to the Development of such Antibody Product for such IndependentIndication required pursuant to Article 4.6(e);

###  

### (d)                                 at least [***][Confidential Treatment Required] in advance of the expected filing date of aDrug Approval Application for such Antibody Product for such IndependentIndication, a copy of such Drug Approval Application; and

###  

### (e)                                  promptly uponbecoming aware of such information, any other information relating to suchIndependent Indication of which the Continuing Party is aware that is ofmaterial commercial significance and which would be reasonably required by theNon-Continuing Party in order to enable the Non-Continuing Party to make aninformed decision as to whether to exercise its option to Convert suchIndependent Indication pursuant to Article 8.9.

###  

In any case where any Antibody Product receivesRegulatory Approval for an Independent Indication, the Parties shall adopt amutually agreeable sales allocation methodology to distinguish sales of suchAntibody Product for such Independent Indication.

 

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## **8.4****                              ****Regulatory Matters**

##  

### (a)                                  Subject to Article8.4(b), the Continuing Party with respect to an Antibody Product for anIndependent Indication shall be the Filing Party with respect to such AntibodyProduct for such Independent Indication and shall be responsible for preparingand filing any Drug Approval Application, and obtaining and maintaining anyRegulatory Approvals, for such Antibody Product for such Independent Indicationin the countries for which it is the Territorial Lead.

###  

### (b)                                 The Non-ContinuingParty with respect to an Independent Indication for an Antibody Product shalluse [***] [Confidential Treatment Required] to assign and transfer to theContinuing Party all interest in and to all INDs and Regulatory Approvals tosuch Antibody Product for such Independent Indication, and shall cooperate withthe Continuing Party [***] [Confidential Treatment Required] to effect suchassignments and transfers in an orderly fashion and shall provide to theContinuing Party any copies of relevant documents and rights of reference andaccess, including with respect to Agreed Indications, necessary to allow theContinuing Party to exercise its rights under this Article 8, *provided*that, if (i) having used such[***] [Confidential Treatment Required], the Non-Continuing Party is unable toeffect such assignments or (ii) the Continuing Party is unable to assume, or itis impractical for the Continuing Party to assume, the responsibility of theFiling Party for that Antibody Product for an Independent Indication, theNon-Continuing Party shall continue to be the Filing Party in respect of that AntibodyProduct and the Continuing Party shall reimburse the Non-Continuing Party inrespect of all [***] [Confidential Treatment Required] incurred by theNon-Continuing Party in acting as Filing Party.

###  

## **8.5****                              ****Information and Materials**

##  

With respect to an Independent Indication foran Antibody Product, the Non-Continuing Party shall promptly transfer to theContinuing Party relevant Information and Materials as provided in Article4.1(a).

 

## **8.6****                              ****Transition for an Independent Indication**

##  

With respect to an Antibody Product for anIndependent Indication, the Non-Continuing Party shall [***] [ConfidentialTreatment Required] transfer to the Continuing Party all Development andCommercialisation and (to the extent applicable) Manufacturing activities inthe Independent Indication and the Collaboration Committee shall promptly meetto devise a transfer plan providing for such transfer in a prompt, smooth,orderly and cost-effective manner and both Parties shall effect such transferin accordance with such plan.  TheDevelopment Plan, Development Budget, Commercialisation Plan andCommercialisation Budget shall be amended to reflect any conversion of anAgreed Indication to an Independent Indication.

 

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## **8.7****                              ****Supply of Antibody Product**

##  

In relation to any Antibody Product for an IndependentIndication, the Continuing Party shall continue to be supplied with ClinicalSupplies and Commercial Supplies of such Antibody Product and, if applicable,supplies of any comparator or placebo, [***] [Confidential Treatment Required]to Develop and Commercialise such Antibody Product for such IndependentIndication under this Agreement as it would were such supplies for an AgreedIndication and if the Continuing Party is not the Manufacturing Coordinator,the Manufacturing Coordinator shall, subject to Article 7.10, continue tocoordinate the supply of Clinical Supplies and Commercial Supplies of thatAntibody Product to the Continuing Party as it would for an Antibody Productfor an Agreed Indication pursuant to Article 7.

 

## **8.8****                              ****Assistance from Non-Continuing Party**

##  

In addition to its obligations with respect toIndependent Indications for which it is the Non-Continuing Party expressly setout elsewhere in this Agreement, and as necessary in order to comply withrelevant Third Party obligations, including In-Licences and ManufacturingAgreements, the Continuing Party may request that the Non-Continuing Partytakes such other actions in its own name in relation to the Development,Manufacture and Commercialisation of an Antibody Product for an IndependentIndication and the Non-Continuing Party shall not [***] [Confidential TreatmentRequired] refuse to take any such action requested by the ContinuingParty.  Save as expressly provided to thecontrary elsewhere in this Agreement, the Non-Continuing Party shall beentitled to [***] [Confidential Treatment Required] in connection withproviding assistance, taking actions or supplying Materials with respect toAntibody Products for Independent Indications (but only to the extent that (i)this Agreement obliges them to provide such assistance, take such actions orsupply such Materials or (ii) the Continuing Party has requested the provisionof such assistance, taking of such actions or supply of such Materials).

 

## **8.9****                              ****Conversion of Independent Indication to Agreed Indication**

##  

### (a)                                  At any time duringthe Term until [***] [Confidential Treatment Required]after an Antibody Productfor an Independent Indication has obtained Regulatory Approval for commercialsale in any of the [***] [Confidential Treatment Required], the Non-ContinuingParty with respect to an Independent Indication for an Antibody Product shallhave the right, on written notice to the Continuing Party (an **Option Exercise Notice**), to convert suchIndependent Indication for such Antibody Product into an Agreed Indication forsuch Antibody Product (such conversion from an Independent Indication to anAgreed Indication, a **Conversion**,with **Convert** being given acorresponding meaning).

###  

#### (i)                                     In connection withthe potential exercise of any such Conversion, the Non-Continuing Party shallhave the right, on written notice to the Continuing Party, to requestadditional information with respect to the applicable Independent Indicationfor the applicable Antibody Product (an **InformationRequest**), *provided* thatexcept as provided in Article 8.9(a)(ii), the Non-Continuing Party shall onlyhave the right to make such a request [***] [Confidential Treatment Required]with respect to

 

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#### each Independent Indication for an Antibody Product.  Within [***] [Confidential TreatmentRequired] of receipt of an Information Request with respect to a particularIndependent Indication for an Antibody Product, the Continuing Party shall providethe Non-Continuing Party with (x) a statement of the Development Costs andReimbursable Commercial Costs incurred by the Continuing Party and itsAffiliates in, and that are specifically identifiable or [***] [ConfidentialTreatment Required] allocable to, the Development and Commercialisation of suchAntibody Product for such Independent Indication from and after the date thatsuch Indication first became an Independent Indication pursuant to Article 8.1or Article 4.7(d) [***] [Confidential Treatment Required] and (y) a DataPackage for such Antibody Product for such Independent Indication (to theextent such information is available or [***] [Confidential Treatment Required]by the Continuing Party), in each case to the end of the Calendar Quarteroccurring immediately before the date of the Information Request.

####  

#### (ii)                                  The Non-ContinuingParty shall have the right to make an Information Request or, if applicable, anadditional Information Request, with respect to each Independent Indication foran Antibody Product, if the Continuing Party with respect to such IndependentIndication fails, and upon written notice from the Non-Continuing Partycontinues to fail for a period of not less than [***] [Confidential TreatmentRequired], to use [***] [Confidential Treatment Required] to Develop or Commercialise,as applicable, such Antibody Product for such Independent Indication (with anyDisputes with respect thereto resolved pursuant to the procedures set forth inArticle 15, [***] [Confidential Treatment Required]) and thereafter theNon-Continuing Party shall have the right to Convert such IndependentIndication for such Antibody Product into an Agreed Indication (suchconversion, a **Default Conversion**)by delivering to the Continuing Party an Option Exercise Notice in accordancewith Article 8.9(a) above (such Option Exercise Notice to specify that it iswith respect to a Default Conversion). [***] [Confidential Treatment Required].

####  

#### (iii)                               If at any time(regardless of whether any Information Request has been made by theNon-Continuing Party) the Non-Continuing Party delivers an Option ExerciseNotice with respect to an Independent Indication for an Antibody Productpursuant to Article 8.9(a) the remaining provisions of this Article 8.9 shallapply.

####  

### (b)                                 The ContinuingParty shall within [***] [Confidential Treatment Required] of receipt of theOption Exercise Notice with respect to an Independent Indication for anAntibody Product, provide the Non-Continuing Party with an updated statement ofall of the Development Costs and Reimbursable Commercial Costs incurred by theContinuing Party and its Affiliates in, and that are specifically identifiableor [***] [Confidential Treatment Required] allocable to, the Development andCommercialisation of such Antibody Product for such Independent Indication fromand after the date that such Indication first became an Independent Indicationpursuant to Article 4.7(d) or

 

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Article 8.1, as applicable, through theeffective date of the Option Exercise Notice with respect thereto, [***][Confidential Treatment Required], subject to audit in accordance with theArticle 8.9(e) (the **Reimbursable Costs**).

###  

### (c)                                  Subject to Article8.9(e), following receipt of the updated statement described in Article 8.9(b)with respect to the Conversion of an Independent Indication for an AntibodyProduct, the Non-Continuing Party shall pay to the Continuing Party, inaccordance with Article 8.9(d), an amount (the **Reimbursement Amount**) equal to:

###  

[***] [ConfidentialTreatment Required]

 

### (d)                                 Subject to Article8.9(e), within [***] [Confidential Treatment Required]of receipt of the updatedstatement described in Article 8.9(b) with respect to the Conversion of anIndependent Indication for an Antibody Product (the **Initial****Payment Period**),the Non-Continuing Party shall pay to the Continuing Party a minimum of [***][Confidential Treatment Required]of the Reimbursement Amount.  If the Non-Continuing Party elects not to paythe full Reimbursement Amount within the Initial Payment Period, the remainderof the Reimbursement Amount shall be payable as follows:

###  

[***] [ConfidentialTreatment Required]

 

Interest calculated in accordance with Article2.3(g) shall accrue on any unpaid portion of the Reimbursement Amount from the[***] [Confidential Treatment Required] of the Initial Payment Period untilpayment of the Reimbursement Amount in full. If the Non-Continuing Party elects not to pay such interest monthly itwill compound in accordance with Article 2.3(g).

 

### (e)                                  The Non-ContinuingParty shall have the right, on written notice to the Continuing Party (suchnotice to be provided within the [***] [Confidential Treatment Required] periodreferred to in Article 8.9(d)), to have the Reimbursable Costs audited inaccordance with the procedures set forth in Article 2.3, and any adjustingpayments shall be calculated and paid in accordance with that Article.  For clarity, the Non-Continuing Party may notserve notice to have the Reimbursable Costs audited after such [***][Confidential Treatment Required] period.

###  

### (f)                                    Upon payment by theNon-Continuing Party to the Continuing Party of at least [***] [ConfidentialTreatment Required] of the Reimbursement Amount in accordance with Article8.9(d), such Independent Indication for such Antibody Product shall be deemedto be Converted to an Agreed Indication (a **ConvertedAgreed Indication**) for such Antibody Product for all purposes underthis Agreement, including with respect to Development Costs and

 

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Operating Profits and Losses, from and afterthe effective date of the applicable Option Exercise Notice.

###  

For clarity, the Non-Continuing Party shall nothave any right or obligation (other than to pay the Reimbursement Amount) toshare any Operating Profits and Losses attributable to a Converted AgreedIndication for an Antibody Product [***] [Confidential Treatment Required].

 

# **9.****                                     ****GRANT OF RIGHTS**

# ** **

## **9.1****                              ****Patent and Know-How Licences**

##  

### (a)                                  Subject to Article9.1(c), UCB (on behalf of itself and its Affiliates) grants to ImClone alicence and, subject in addition to Article 9.2, a sublicence (with respect toThird Party rights Controlled by UCB) under the UCB Patent Rights, UCBKnow-How, Joint Patent Rights (to the extent Controlled by UCB), theManufacturing Know-How (to the extent Controlled by UCB), the ManufacturingPatents (to the extent Controlled by UCB) and the Joint Know-How (to the extentControlled by UCB) to: (i) Develop Antibody Products for Agreed Indications inthe Field in the Territory; (ii) Commercialise, use, sell, have sold, offer tosell, resell, import, export, distribute or otherwise transfer physicalpossession of or otherwise transfer title in Antibody Products in the Field inthe ImClone Territory, *provided*that ImClone and its permitted sublicensees shall have the right to conductPost-Approval Studies throughout the Territory; (iii) Develop Antibody Productsfor Independent Indications for which ImClone is the Continuing Party in theField in the Territory, *provided*that ImClone shall only have the right to file Drug Approval Applications forsuch Independent Indications in the ImClone Territory; (iv) subject to Article16.5, [***] [Confidential Treatment Required]; and (v) Manufacture AntibodyProducts in the Territory as necessary or useful to: (A) exercise ImClone’srights under Article 9.1(a)(i) through (iv), and (B) if ImClone is aManufacturer, as necessary to satisfy ImClone’s obligations under thisAgreement and any Manufacturing Agreement to which it is a party; in each caseonly in accordance with and subject to the terms of this Agreement.

###  

### (b)                                 Subject to Article9.1(d), ImClone (on behalf of itself and its Affiliates) grants to UCB alicence and, subject in addition to Article 9.2, a sublicence (with respect toThird Party rights Controlled by ImClone) under the ImClone Patent Rights,ImClone Know-How, Joint Patent Rights (to the extent Controlled by ImClone),the Manufacturing Know-How (to the extent Controlled by ImClone), theManufacturing Patents (to the extent Controlled by ImClone) and the JointKnow-How (to the extent Controlled by ImClone) to: (i) Develop AntibodyProducts for Agreed Indications in the Field in the Territory; (ii)Commercialise, use, sell, have sold, offer to sell, resell, import, export,distribute or otherwise transfer physical possession of or otherwise transfertitle in Antibody Products in the Field in the UCB Territory, *provided* that UCB and its permittedsublicensees shall have the right to conduct Post-Approval Studies throughoutthe Territory; (iii) Develop Antibody Products for Independent Indications forwhich UCB is the Continuing Party in the Field in the Territory, *provided* that UCB shall only have theright to file Drug Approval Applications for such Independent Indications inthe UCB Territory;

 

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(iv) subject to Article 16.5, [***][Confidential Treatment Required]; and (v) Manufacture Antibody Products in theTerritory as necessary or useful to: (A) exercise UCB’s rights under Article9.1(b)(i) through (iv), and (B) if UCB is a Manufacturer, as necessary tosatisfy UCB’s obligations under this Agreement and any Manufacturing Agreementto which it is a party; in each case only in accordance with and subject to theterms of this Agreement.

###  

### (c)                                  The licences andsublicences granted by UCB pursuant to Article 9.1(a) shall, to the extentpossible:  (i) be [***] [ConfidentialTreatment Required] with respect to:  (A)Development activities relating to Antibody Products for Agreed Indications inthe Field in the Territory; (B) Post-Approval Studies for Antibody Product inthe Field in the Territory; and (C) Manufacturing activities relating toAntibody Products in the Field in the Territory; and (ii) be [***][Confidential Treatment Required] to ImClone and its Affiliates with respectto:  (A) Development activities relatingto Antibody Products for Independent Indications for which ImClone is theContinuing Party in the Field in the Territory and (B) Commercialisationactivities (other than Post-Approval Studies) related to Antibody Products inthe Field in the ImClone Territory.  Inso far as UCB does not[***] [Confidential Treatment Required].

###  

### (d)                                 The licences andsublicences granted by ImClone pursuant to Article 9.1(b) shall, to the extentpossible: (i) be [***] [Confidential Treatment Required] with respect to:  (A) Development activities relating toAntibody Products for Agreed Indications in the Field in the Territory; (B)Post-Approval Studies for Antibody Product in the Field in the Territory; and(C) Manufacturing activities relating to Antibody Products in the Field in theTerritory; and (ii) be [***] [Confidential Treatment Required] with respectto:  (A) Development activities relatingto Antibody Products for Independent Indications for which UCB is theContinuing Party in the Field in the Territory and (B) Commercialisationactivities (other than Post-Approval Studies) related to Antibody Products inthe Field in the UCB Territory. In so far as ImClone does not [***][Confidential Treatment Required]

###  

### (e)                                  From and after theEffective Date during the Term neither Party shall, and each Party shallprocure that its Affiliates and sublicensees shall, not use or exercise anyrights granted to it pursuant to this Agreement save for the purposes ofDevelopment, Manufacturing and Commercialising Antibody Products in accordancewith and subject to the terms of this Agreement.

###  

### (f)                                    For purposes ofthis Article 9.1, co-exclusive shall mean that the Party granting theco-exclusive licence shall not have the right to grant further licences toThird Parties under its relevant intellectual property rights if and to theextent such further licences would be inconsistent with an exclusive grant ofsuch rights to the other Party, except to the extent that it would be permittedto grant sublicences to such intellectual property rights under Article 9.5were such intellectual property rights licensed to it by the other Party.

###  

### (g)                                 Without limitingany other grant made pursuant to this Agreement, UCB (on behalf of itself andits Affiliates) grants to ImClone a [***] [Confidential Treatment Required].

 

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## **9.2****                              ****Third Party Licences**

##  

Certain licence rights granted to a Party underthis Article 9 may include a sublicence of Patent Rights, Information and/orMaterials of Third Parties under In-Licences. Notwithstanding anything to the contrary in this Agreement thesublicence rights granted pursuant to Article 9.1 shall not be interpreted toexceed the scope of rights granted under the In-Licences in relation to therights covered by such In-Licences, in each case as disclosed to thesublicensee Party.  Each Party shallpromptly provide to the other Party a copy of any notice of breach received by itin respect of any In-Licence, and shall use [***] [Confidential TreatmentRequired] to promptly cure any such breach.

 

## **9.3****                              ****Obligation to Maintain In-Licences**

##  

Neither Party shall terminate or amend anIn-Licence in any manner that affects [***] [Confidential TreatmentRequired].  Each Party shall promptlynotify to the other Party any notice of termination received by it in respectof any In-Licence.

 

## **9.4****                              ****Trademark Licences/Promotional Materials**

##  

### (a)                                  Each Party herebygrants to the other Party [***] [Confidential Treatment Required] with the rightto grant sublicences, to use each Product Trademark for each Antibody Productin respect of which it is the Product Trademark Owner, in each case solely infurtherance of the other Party’s Development activities for such AntibodyProducts in the countries for which such first Party is the Product TrademarkOwner pursuant to this Agreement.

###  

### (b)                                 Each Party, onbehalf of itself and its Affiliates, hereby grants to the other Party, a [***][Confidential Treatment Required] with the right to grant sublicences, to usesuch granting Party’s Corporate Mark solely in connection with PromotionalMaterials, packaging and Product Labelling for Antibody Products, limited inscope to the uses specified in Article 6.12.

###  

### (c)                                  Each Party grantsto the other Party a [***] [Confidential Treatment Required], to reproduce,distribute copies of, prepare derivative works of, and publicly perform anddisplay Promotional Materials or additional Antibody Product-specific materialssolely in connection with Antibody Products in the Field in the ImCloneTerritory or UCB Territory (as appropriate) and in accordance with and subjectto the terms of this Agreement.

###  

## **9.5****                              ****Sublicences**

##  

### (a)                                  Each Party shallhave the right to grant sublicences to its Affiliates under the licencesgranted to it in Articles 9.1(a), 9.1(b), 9.1(g) and 9.4, as the case may be,[***] [Confidential Treatment Required], but subject to any approvals requiredtherefor from any applicable Third Party licensor.

###  

### (b)                                 ImClone and itsAffiliates shall have the right to grant sublicences to Third Parties throughmultiple tiers under the licences granted to it in Articles 9.1(a) and 9.4, asthe case may be:

 

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#### (i)                                     with the consent ofUCB, if and to the extent that the sublicence permits the sublicensee to use orexploit the relevant sublicensed rights [***] [Confidential TreatmentRequired]; and

####  

#### (ii)                                  with the consent ofUCB [***] [Confidential Treatment Required], if and to the extent that thesublicence permits the sublicensee to use or exploit the relevant sublicensedrights [***] [Confidential Treatment Required],

####  

but subject, in each case, to any approvalsrequired therefor from any applicable Third Party licensor.

 

### (c)                                  UCB and itsAffiliates shall have the right to grant sublicences to Third Parties throughmultiple tiers under the licences granted to it in Articles 9.1(b) and 9.4, asthe case may be:

###  

#### (i)                                     with the consent ofImClone, if and to the extent that the sublicence permits the sublicensee touse or exploit the relevant sublicensed rights [***] [Confidential TreatmentRequired]

####  

#### (ii)                                  with the consent ofImClone [***] [Confidential Treatment Required], if and to the extent that thesublicence permits the sublicensee to use or exploit the relevant sublicensedrights [***] [Confidential Treatment Required]; and

####  

#### (iii)                               without the consentof, but following reasonable consultation with, ImClone if and to the extentthat the sublicence permits the sublicensee to use or exploit the relevantsublicensed rights [***] [Confidential Treatment Required],

####  

but subject, in each case, to any approvalsrequired therefor from any applicable Third Party licensor.

 

### (d)                                 Subject to Articles9.5(a), (b) and (c), neither Party shall have the right to grant sublicencesunder the licences granted to it in Articles 9.1(a), 9.1(b) and/or 9.4, as thecase may be, [***] [Confidential Treatment Required].

###  

### (e)                                  Each Party herebyguarantees the performance of its Affiliates and permitted sublicensees thatare sublicensed as permitted in this Article****9.5and the grant of any such sublicence shall not relieve the sublicensing Partyof its obligations under this Agreement, except to the extent they aresatisfactorily performed by such sublicensee. Any such permitted sublicences shall be subordinate to, consistent withand subject to the terms and conditions of this Agreement and any applicableIn-Licences.  A copy of any sublicenceagreement executed by one Party shall be provided to the other Party within[***] [Confidential Treatment Required] after its execution; *provided* that the financial terms of anysuch sublicence agreement may be redacted to the extent not pertinent to anunderstanding of a Party’s obligations or benefits under this Agreement.  Any sublicence agreement with a Third Partyundertaking Commercialisation activity with respect to an Antibody Product

 

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for an Agreed Indication shall be in writingand shall contain the following provisions:

###  

#### (i)                                     [***] [ConfidentialTreatment Required]

####  

#### (ii)                                  [***] [ConfidentialTreatment Required]

####  

#### (iii)                               [***] [ConfidentialTreatment Required]

####  

### (f)                                    Each Party shalluse [***] [Confidential Treatment Required] to ensure that any sublicenceagreement it enters into with a Third Party provides that on termination of thelicences granted to the relevant Party pursuant to this Agreement (or thosewhich are subject to the sublicence), the Remaining Party may elect to replacethe Non-Remaining Party as licensor under such sublicence agreement.

###  

### (g)                                 ImClone and itsAffiliates shall have the right to grant sublicences to Third Parties throughmultiple tiers under the licences granted to it in Article 9.1(g) without theconsent of UCB.

###  

# **10.****                              ****RIGHTS IN INTELLECTUAL PROPERTY**

# ** **

## **10.1****                       ****Ownership**

##  

### (a)                                  IndependentOwnership

###  

Subject to the licence grants under Article 9and except as otherwise provided in Article 4.10 and Article 9.1(c), as betweenthe Parties, each Party shall own and retain all right, title and interest inand to any and all: (a) Information, Materials and inventions that arecharacterised, conceived, developed, derived, discovered, generated, identifiedor otherwise made, by or on behalf of such Party (or its Affiliates or itslicensees or sublicensees (other than the other Party and its Affiliates)) asdetermined in accordance with Article 10.1(e) under or in connection with thisAgreement, whether or not patented or patentable, and any and all PatentRights, copyrights, trademark rights, trade secret rights and otherintellectual property or other proprietary rights with respect thereto, exceptto the extent that any such Information, Materials or inventions, or any PatentRights or such other intellectual property or other proprietary rights withrespect thereto, are Joint Know-How or Joint Patents, and (b) otherInformation, Materials or inventions, and Patent Rights and such otherintellectual property rights (including the Corporate Marks but excluding JointPatent Rights and Joint Know-How) that are owned or otherwise Controlled bysuch Party, its Affiliates or its licensees or sublicensees (other than theother Party and its Affiliates).

 

### (b)                                 **ProductTrademark**

###  

As between the Parties, each Party shall ownall right, title and interest in and to the Product Trademark [***][Confidential Treatment Required] (each Party being the **Product Trademark Owner** [***] [ConfidentialTreatment Required]).

 

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### (c)                                  **ManufacturingPatents and Know How**

###  

As between the Parties, ownership ofManufacturing Know-How and Manufacturing Patents generated by or on behalf of aParty as a result of its activities as a Manufacturer shall be governed by theterms of the applicable Manufacturing Agreement or existing supply agreementlisted in Schedule 4.

 

### (d)                                 **JointOwnership**

###  

Each Party shall own an undivided one-halfinterest in and to the Joint Patent Rights and the Joint Know-How with fullownership rights in and to any field and each Party shall have the right, subjectto the rights and licences granted under, and the other provisions of, thisAgreement, to freely exploit, transfer, license or encumber its rights in anysuch jointly owned subject matter (together with all Patent Rights and otherintellectual property and proprietary rights in that subject matter) withoutthe consent of, or payment or accounting to, the other Party, and each Partywaives any right it may have under any Applicable Law to require such payment,accounting or consent.  This Articleshall survive termination of this Agreement howsoever caused.  During the Term, each Party shall promptlydisclose to the other Party in writing, and shall cause its Affiliates andsublicensees to so disclose, the characterisation, conception, development,derivation, discovery, generation, identification or making of any Information,Materials or inventions (but, for clarification, excluding any ManufacturingKnow-How) in the course of work conducted under or in connection with thisAgreement.  Each Party shall, and doeshereby, assign, and shall cause its Affiliates and sublicensees to so assign,to the other Party, without additional compensation, such right, title andinterest in and to any Joint Patent Rights or Joint Know-How as well as anyintellectual property or other proprietary rights with respect thereto, as isnecessary to fully effect the joint ownership provided for in this Article10.1(d).

 

### (e)                                  **InventorshipDetermination; Identification of Collaboration Inventions**

###  

The JPC shall, within a reasonable time afterthe Effective Date, establish and oversee a mutually agreeable procedure foridentifying and determining inventorship of inventions made pursuant to theDevelopment, Commercialisation and Manufacturing (but excluding ManufacturingKnow-How) or other activities conducted under or in connection with thisAgreement.  All such determinations anddesignations shall be documented to ensure that any applications for PatentRights reflect appropriate inventorship and that inventions and Patent Rightsare assigned to or held by the appropriate Party.  The determination of whether any Information,Material or invention is characterized, conceived, developed, derived,discovered, generated, identified or otherwise made by a Party or any of itsAffiliates, sublicensees or Distributors shall be made in accordance withApplicable Law in the United States.

 

### (f)                                    **NoObligation to Licence**

###  

Other than as expressly set out in thisAgreement, neither Party shall have any right in and to intellectual propertyowned or Controlled by the other Party and neither Party shall have anobligation to grant the other Party any rights in or to any such intellectualproperty.

 

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### (g)                                 **Reservationof Prosecution Right**

###  

Other than as expressly set out in this Article10, neither Party shall have the right to prepare, file, apply for, register,prosecute, maintain, defend, litigate, settle and/or enforce Patent Rights orTrademarks Controlled by the other Party, such activity being the exclusiveright (but not the obligation) of the Party Controlling the same.

 

## **10.2****                       ****Covenants Related to Product Trademarks and Corporate Marks**

##  

### (a)                                  During the periodcommencing on the Effective Date and ending on the date (if any) on which theProduct Trademark Owner assigns (or is obliged to assign) to the other Partypursuant to Article 12.8(c), the Product Trademark Owner’s right, title andinterest in and to the Product Trademarks, such other Party acknowledges andagrees that (i) [***] [Confidential Treatment Required] and (ii) all use ofsuch Product Trademarks in the countries for which the Product Trademark Owneris the Territorial Lead whether in combination with or apart from the ProductTrademark Owner’s Corporate Marks, including any goodwill generated inconnection therewith, inures to the benefit of the Product Trademark Owner, andthe Product Trademark Owner may call for a confirmatory assignmentthereof.  Each Party shall use [***][Confidential Treatment Required] not to do any act which endangers, destroysor similarly affects, in any material respect, the value of the goodwillpertaining to the Product Trademarks.

###  

### (b)                                 Each Party agreesthat it shall not attack, dispute or contest the validity of or ownership ofthe other Party’s Corporate Mark, or any registration issued or issuing withrespect thereto.  Each Party expresslyacknowledges and agrees that no ownership rights are vested or created in theother Party’s Corporate Marks by the limited rights of use granted pursuant toArticle 9.4(b), and that all use of such Corporate Marks in accordancetherewith, including any goodwill generated in connection therewith, inures tothe benefit of the owner of such Corporate Marks and the owner of suchCorporate Marks may call for a confirmatory assignment thereof.  With respect to any Corporate Marks licensedto a Party under Article 9.4(b), such Party agrees to conform to the customaryguidelines and quality standards of the granting Party with respect to manner ofuse (as provided in writing by the owner of the Corporate Marks).  Each Party shall use [***] [ConfidentialTreatment Required] not to do any act which endangers, destroys or otherwiseadversely affects the value of the goodwill pertaining to the other Party’sCorporate Marks.  Neither Party shalluse, or allow any of their Affiliates, sublicensees or Distributors to use, inconnection with any Antibody Product any other Trademark that is similar to orsubstantially similar to or so nearly resembles any of the other Party’sCorporate Marks as to be likely to cause deception or confusion.

###  

## **10.3****                       ****Disclosure of Patentable Inventions and Patent Due Diligence**

##  

### (a)                                  Each Party shallpromptly notify the other Party of any patentable invention made by it or itsAffiliates or, to the extent it has rights thereto, sublicensees orDistributors pursuant to the Development, Commercialisation, Manufacturing orother activities performed by it or them under this Agreement (but excludingany patentable invention with respect to Manufacturing Know-How Controlled by aThird Party Manufacturer), and shall provide to the other

 

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Party any invention disclosure submitted in thenormal course of its business which discloses any such invention.

###  

### (b)                                 Each Party agreesto use [***] [Confidential Treatment Required] to bring to the attention of theJoint Patent Committee in a timely manner any Third Party patent or Third Partypatent application it discovers, or has discovered, and which such Partyreasonably believes relates to, the Development, Commercialisation orManufacture of any Antibody Product.

###  

## **10.4****                       ****Patent and Trademark Filing, Prosecution and Maintenance**

##  

### (a)                                  **ImClonePatent Rights and ImClone Company Marks**

###  

#### (i)                                     ImClone Core PatentRights

####  

Decisions regarding the preparation, filing,prosecution and maintenance of ImClone Core Patent Rights shall be made byImClone following reasonable consultation with the JPC.  Prior to implementing any decision regardingthe preparation, filing, prosecution and maintenance of such ImClone CorePatent Rights, ImClone shall give due consideration to any representation madeby the JPC with respect to such preparation, filing, prosecution andmaintenance.  ImClone shall provide theJPC with an opportunity to review and comment upon the text of the applicationsrelating to such ImClone Core Patent Rights before filing.  ImClone shall provide the JPC with a copy ofeach patent application within such ImClone Core Patent Rights as filed,together with notice of its filing date and serial number.  ImClone shall keep the JPC advised of thestatus of all communications, actual and prospective filings or submissionsregarding such ImClone Core Patent Rights, and shall give the JPC anopportunity to review and comment on any such communications, filing andsubmissions proposed to be sent to any patent office.  Notwithstanding the foregoing, ImClone shallnot cease the prosecution and/or maintenance of, or elect not to file a patentapplication in respect of any ImClone Core Patent Rights, unless otherwiseapproved by the JPC [***] [Confidential Treatment Required].  All out of pocket costs incurred by theParties in connection with the preparation, filing, prosecution and maintenanceof ImClone Core Patent Rights shall be [***] [Confidential Treatment Required]

 

#### (ii)                                  Other ImClonePatent Rights and ImClone Company Marks

####  

Decisions regarding the preparation, filing,prosecution and maintenance of ImClone Company Marks and ImClone Patent Rights,other than ImClone Core Patent Rights, shall be made by ImClone.

 

### (b)                                 **UCBPatent Rights and UCB Company Marks**

###  

#### (i)                                     UCB Core PatentRights

####  

Decisions regarding the preparation, filing,prosecution and maintenance of UCB Core Patent Rights shall be made by UCBfollowing reasonable consultation with the JPC. Prior to implementing any decision regarding the

 

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preparation, filing, prosecution andmaintenance of such UCB Core Patent Rights, UCB shall give due consideration toany representations made by the JPC with respect to such preparation, filing,prosecution and maintenance.  UCB shallprovide the JPC with an opportunity to review and comment upon the text of theapplications relating to such UCB Core Patent Rights before filing.  UCB shall provide the JPC with a copy of eachpatent application within such UCB Core Patent Rights as filed, together withnotice of its filing date and serial number. UCB shall keep the JPC advised of the status of all communications,actual and prospective filings or submissions regarding such UCB Core PatentRights, and shall give the JPC an opportunity to review and comment on any suchcommunications, filing and submissions proposed to be sent to any patentoffice.  Notwithstanding the foregoing,UCB shall not cease the prosecution and/or maintenance of, or elect not to filea patent application in respect of any UCB Core Patent Rights, unless otherwiseapproved by the JPC [***] [Confidential Treatment Required].  All out of pocket costs incurred by theParties in connection with the preparation, filing, prosecution and maintenanceof UCB Core Patent Rights shall be [***] [Confidential Treatment Required].

 

#### (ii)                                  Other UCB PatentRights and UCB Company Marks.

####  

Decisions regarding the preparation, filing,prosecution and maintenance of UCB Company Marks and UCB Patent Rights, otherthan UCB Core Patent Rights, shall be made by UCB.

 

### (c)                                  **JointPatent Rights**

###  

Decisions regarding the preparation, filing,prosecution and maintenance of the Joint Patent Rights shall be made by theJPC.  Upon the identification of JointKnow-How, the JPC shall: (i) promptly discuss such Joint Know-How; (ii)promptly discuss the desirability of filing patent application(s) covering suchJoint Know-How, and the relevant countries for filing; (iii) make the finaldecision with respect to any such filings as soon as practicable; and (iv)designate the Party (the **Controlling Party**)to be responsible for the preparation, filing, prosecution and maintenance ofsuch Joint Patent Rights, with the expectation being that each Party shall bethe Controlling Party with respect to Joint Patent Rights in countries forwhich it is the Territorial Lead, *provided*that no Party shall be designated as a Controlling Party without its writtenconsent.  All out of pocket costs incurredby the Parties in connection with the preparation, filing, prosecution andmaintenance of Joint Patent Rights [***] [Confidential TreatmentRequired].  The Controlling Party shallbe responsible, using in-house counsel or outside counsel reasonably acceptableto both Parties, to implement the decisions of the JPC regarding thepreparation, filing, prosecution and maintenance of such Joint PatentRights.  The Controlling Party shall (A)provide the JPC an opportunity to review and comment upon the text of theapplications relating to; (B)  providethe JPC with a copy of each patent application filed, together with notice ofthe filing date and serial number of; (C) keep the JPC advised of the status ofall communications, actual and prospective filings or submissions regarding;(D) provide the JPC an opportunity to review and comment on any communications,filings and submissions proposed to be sent to any patent office relating to;(E) notify the JPC of the grant of; (F) not, unless otherwise approved by theJPC [***] [Confidential Treatment Required], cease the prosecution ormaintenance of, or

 

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modify the claims of, or elect not to file apatent application in respect of; any Joint Patent Rights.  If one Party [***] [Confidential TreatmentRequired].  If the other Party fails tonotify the first Party within [***] [Confidential Treatment Required], and thefirst Party is the Controlling Party, the Controlling Party [***] [ConfidentialTreatment Required] such Joint Patent Rights during that [***] [ConfidentialTreatment Required]).

 

### (d)                                 **ProductTrademarks**

###  

Decisions regarding the preparation, filing,prosecution and maintenance of registrations for the Product Trademarks in acountry shall be made by, and registrations for the Product Trademarks in acountry shall be filed and prosecuted by, the Product Trademark Owner in suchcountry, and any expenses related to such preparation (including clearance ofmarks), filing, prosecution or maintenance [***] [Confidential TreatmentRequired], *provided* the otherParty shall have a reasonable opportunity to review and comment upon drafts ofany new application to register a Product Trademark and all correspondence,amendments and submissions of any kind to any and all trademark officesconcerning the Product Trademark registrations, prior to filing thatapplication, correspondence, amendment or submission.  Notwithstanding the foregoing, if a ProductTrademark Owner declines to prepare, file or prosecute any Trademark registration,or maintain any such Trademark, comprising Product Trademarks for which it isthe Product Trademark Owner as required by this Article 10.4(d), it shall givethe other Party reasonable notice to this effect and, the other Party may, uponwritten notice to the Product Trademark Owner, prepare, file, prosecute andmaintain such Product Trademarks in the name of the Product Trademark Owner andany expenses related to such filing, prosecution or maintenance shall be [***][Confidential Treatment Required].

 

### (e)                                  **PatentTerm Extensions**

###  

The JPC shall make determinations as to whetherto seek patent term extensions, including supplementary protection certificatesand any other extensions that are now or become available in the futureregarding the ImClone Core Patent Rights, UCB Core Patent Rights or JointPatent Rights with respect to the Antibody Products in each country in theTerritory so as to secure optimal protection for each such Antibody Productunder Applicable Law, *provided*that no such extensions shall be sought with respect to the UCB Core PatentRights without UCB’s prior consent or the ImClone Core Patent Rights withoutImClone’s prior consent.  ImClone shallbe responsible for implementing any patent term extensions, includingsupplementary protection certificates and any other extensions that are now orbecome available in the future, for the ImClone Core Patents and UCB shall beresponsible for implementing patent term extensions, including supplementaryprotection certificates and any other extensions that are now or becomeavailable in the future, for the UCB Core Patents.  The Controlling Party shall be responsiblewherever applicable, for implementing any patent term extensions, includingsupplementary protection certificates and any other extensions that are now orbecome available in the future, for Joint Patent Rights.  Each Party shall [***] [ConfidentialTreatment Required] cooperate, as requested by the other Party, to implementsuch decisions of the Joint Patent Committee. Any costs incurred in connection with seeking patent term extensionsshall be [***] [Confidential Treatment Required].

 

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## **10.5****                       ****Interferences, Reexaminations, Reissues, Revocations andOppositions With Third Parties**

##  

### (a)                                  **ImCloneCore Patent Rights and Product Trademarks for which ImClone is the ProductTrademark Owner**

###  

All decisions relating to AdversarialProsecution Actions with respect to ImClone Core Patent Rights or ProductTrademarks for which ImClone is the Product Trademark Owner, including whetherto initiate or settle such Adversarial Prosecution Actions, shall be made byImClone having consulted with, and with the advice of, the JPC.  ImClone shall be responsible for the conductof any such Adversarial Prosecution Action. UCB shall [***] [Confidential Treatment Required] cooperate, asrequested by ImClone, with respect to such Adversarial Prosecution Action.  ImClone shall keep the JPC informed of theprogress of any such Adversarial Prosecution Action.  ImClone shall keep the JPC advised of allcommunications, actual and prospective filings or submissions regarding suchAdversarial Prosecution Action, and shall provide the JPC with an opportunityto review and comment on any such communications, filings and submissions, *provided* that ImClone shall have the firstright to conduct (including to initiate, defend and control, including theright to settle or compromise and to grant licences under the ImClone CorePatent Rights or Product Trademarks for which ImClone is the Product Trademarkowner in connection therewith) any such Adversarial Prosecution Action.   If ImClone fails to institute an AdversarialProsecution Action with respect to ImClone Core Patent Rights or a ProductTrademark in a country where ImClone is the Product Trademark Owner within[***] [Confidential Treatment Required] after a written request by UCB to doso, or otherwise conduct or defend any such Adversarial Prosecution Action,within [***] [Confidential Treatment Required] after a written request by UCBto do so, then UCB, on written notice to ImClone, shall have the right, duringor after the Term, [***] [Confidential Treatment Required] to initiate, conductor defend, as applicable, and control, such Adversarial Prosecution Action *provided* that UCB shall not settle orconsent to a judgment in any such Adversarial Prosecution Action if suchsettlement or judgment would have a material adverse effect on ImClone unlessapproved by ImClone [***] [Confidential Treatment Required].  All out-of-pocket expenses incurred inrelation to any Adversarial Prosecution Action under this Article 10.5(a) shallbe [***] [Confidential Treatment Required].

 

### (b)                                 **OtherImClone Patent Rights and ImClone Company Marks**

###  

All decisions relating to Adversarial ProsecutionActions with respect to ImClone Company Marks and ImClone Patent Rights, otherthan ImClone Core Patent Rights, including whether to initiate or settle suchAdversarial Prosecution Actions, shall be made by ImClone.  All expenses incurred and recoveries obtainedin relation to any such Adversarial Prosecution Action shall be [***][Confidential Treatment Required].

 

### (c)                                  **UCBCore Patent Rights and Product Trademarks for which UCB is the ProductTrademark Owner**

###  

All decisions relating to AdversarialProsecution Actions with respect to UCB Core Patent Rights or ProductTrademarks for which UCB is the Product Trademark Owner, including whether toinitiate or settle such Adversarial Prosecution Actions,

 

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shall be made by UCB having consulted with, andwith the advice of, the JPC.  UCB shallbe responsible for the conduct of any such Adversarial Prosecution Action.  ImClone shall [***] [Confidential TreatmentRequired] cooperate, as requested by UCB, with respect to such AdversarialProsecution Action.  UCB shall keep theJPC informed of the progress of any such Adversarial Prosecution Action.  UCB shall keep the JPC advised of allcommunications, actual and prospective filings or submissions regarding suchAdversarial Prosecution Action, and shall provide the JPC with an opportunityto review and comment on any such communications, filings and submissions, *provided* that UCB shall have the firstright to conduct (including to initiate, defend and control, including theright to settle or compromise and to grant licences under the UCB Core PatentRights or Product Trademarks for which UCB is the Product Trademark Owner inconnection therewith) any such Adversarial Prosecution Action.  If UCB fails to institute an AdversarialProsecution Action with respect to UCB Core Patent Rights or a ProductTrademark in a country where UCB is the Product Trademark Owner within [***][Confidential Treatment Required] after a written request by ImClone to do so,or otherwise conduct or defend any such Adversarial Prosecution Action, within[***] [Confidential Treatment Required] after a written request by ImClone todo so, then ImClone, on written notice to UCB, shall have the right, during orafter the Term, at its sole discretion to initiate, conduct or defend, asapplicable, and control, such Adversarial Prosecution Action *provided* that ImClone shall not settle orconsent to a judgment in any such Adversarial Prosecution Action if suchsettlement or judgment would have a material adverse effect on UCB unlessapproved by UCB [***] [Confidential Treatment Required].  All out-of-pocket expenses incurred inrelation to any Adversarial Prosecution Action under this Article 10.5(c) shallbe [***] [Confidential Treatment Required].

 

### (d)                                 **OtherUCB Patent Rights and UCB Company Marks**

###  

All decisions relating to AdversarialProsecution Actions with respect to UCB Company Marks and UCB Patent Rights,other than UCB Core Patent Rights, including whether to initiate or settle suchAdversarial Prosecution Actions, shall be made by UCB.  All expenses incurred and recoveries obtainedin relation to any such Adversarial Prosecution Action shall be borne orretained, as applicable, by UCB.

 

### (e)                                  **JointPatent Rights, Third Party Patent Rights and Third Party Trademarks**

###  

Decisions relating to Adversarial ProsecutionActions with respect to Joint Patent Rights and decisions relating toAdversarial Prosecution Actions against Third Party Patent Rights or ThirdParty Trademarks relevant to an Antibody Product, including in each casedecisions whether to initiate or settle such Adversarial Prosecution Actions,shall be made by the JPC.  Upon theidentification of any such potential Adversarial Prosecution Action, the JPCshall: (i) promptly discuss such Adversarial Prosecution Action, including thestrategy for conducting such Adversarial Prosecution Action; and(ii) designate a Party (the **ManagingParty**) to be responsible for controlling such AdversarialProsecution Action, *provided* thatno Party shall be designated as a Managing Party [***] [Confidential TreatmentRequired].  The Managing Party shall beresponsible, using outside counsel reasonably acceptable to both Parties, toimplement the decisions of the Joint Patent Committee regarding such AdversarialProsecution Action.  Save as provided inthis Article 10.5(e), all expenses incurred in relation to any such AdversarialProsecution Action shall be [***]

 

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[Confidential Treatment Required].  The non-Managing Party shall [***][Confidential Treatment Required]cooperate, as requested by the JPC or theManaging Party, in such Adversarial Prosecution Action.  The Managing Party shall keep the JPCinformed of the progress of any such Adversarial Prosecution Action.  The Managing Party shall keep the JPC advisedof all communications, actual and prospective filings or submissions regardingsuch Adversarial Prosecution Action, and shall provide the JPC an opportunityto review and comment on any such communications, filings and submissions.  The Managing Party shall not settle orconsent to a judgment in any such Adversarial Prosecution Action with respectto the Joint Patent Rights, Third Party Patent Rights or Third PartyTrademarks, unless approved by the JPC [***] [Confidential TreatmentRequired].  If a Party does not wish toshare the costs of prosecuting any such Adversarial Prosecution Actions againstThird Party Patent Rights or Third Party Trademarks relevant to an AntibodyProduct, the other Party shall have the right to prosecute such action, at itssole expense, through counsel of its choosing, without the consent of suchfirst Party or the JPC, *provided*that that such other Party shall be [***] [Confidential TreatmentRequired].  If a Party elects to initiateor continue prosecuting an Adversarial Prosecution Actions against Third PartyPatent Rights or Third Party Trademarks relevant to an Antibody Product at itsown expense as provided in the preceding sentence, the other Party shall, andshall cause its Affiliates to, [***] [Confidential Treatment Required]cooperatewith such first Party in this regard. For clarity, neither Party shall have the right not to fund, or to ceasedefending, an Adversarial Prosecution Action brought by a Third Party withrespect to Joint Patent Rights, except with respect to a counterclaim broughtby a Third Party in connection with an Adversarial Prosecution Action against aThird Party Patent as to which such Party previously exercised its right not tofund.

 

## **10.6****                       ****Initial Filings**

##  

The Parties agree to use [***] [ConfidentialTreatment Required] to ensure that any Patent Rights within the ImClone CorePatent Rights, UCB Core Patent Rights and Joint Patent Rights will be in a formsufficient to establish the date of original filing as a priority date for thepurposes of filing throughout the Territory.

 

## **10.7****                       ****Enforcement and Defence of Patent Rights and Trademarks**

##  

### (a)                                  **Notificationof Infringement**

###  

If either Party learns of any Third Partymaking, using, offering for sale, selling or importing an Antibody Product or aCompeting Product, in each case in or outside of the Field, or using aTrademark that could reasonably be deemed to infringe a Product Trademark, theJoint Patent Rights or one of the other Party’s Patent Rights or Trademarks,such Party shall promptly notify the other Party and shall provide such otherParty with available evidence of such activity.

 

### (b)                                 **Enforcement**

###  

#### (i)                                     ImClone Core PatentRights and Product Trademarks for which ImClone is the Product Trademark Owner

####  

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As between the Parties, ImClone shall withrespect to ImClone Core Patent Rights and Product Trademarks for which ImCloneis the Product Trademark Owner during the Term have the first right andthereafter with respect to ImClone Core Patent Rights, the sole right, usingoutside counsel selected by ImClone, to initiate or defend (as appropriate) andcontrol Enforcement Actions with respect to ImClone Core Patent Rights andProduct Trademarks for which ImClone is the Product Trademark Owner.  UCB shall [***] [Confidential TreatmentRequired] cooperate, as requested by ImClone, with respect to such EnforcementActions.  ImClone shall keep the JPCinformed of the progress of any such Enforcement Action.  ImClone shall keep the JPC advised of allcommunications, actual and prospective filings and submissions regarding anysuch Enforcement Action and shall provide the JPC with an opportunity to reviewand comment on any such communications, filings and submissions.  If ImClone fails during the Term to instituteor defend any such Enforcement Action with respect to ImClone Core PatentRights or a Product Trademark for which ImClone is the Product Trademark Owner,within [***] [Confidential Treatment Required] after a written request by UCBto do so, then UCB, on written notice to ImClone, shall have the right at itssole discretion to initiate or defend (as appropriate) and control suchEnforcement Action in the name of either or both Parties *provided* that UCB shall not settle orconsent to a judgment in any such Enforcement Action if such settlement orjudgment would have a material adverse effect on ImClone unless approved byImClone [***] [Confidential Treatment Required].  If, after the Term, ImClone fails to initiateor defend any such Enforcement Action with respect to ImClone Core PatentRights, UCB shall have no right to initiate or defend and control suchEnforcement Action but any [***] [Confidential Treatment Required]  All out of pocket expenses incurred inrelation to any Enforcement Action under this Article 10.7(b)(i) shall be [***][Confidential Treatment Required].

 

#### (ii)                                  Other ImClonePatent Rights and ImClone Company Marks

####  

All decisions relating to Enforcement Actionswith respect to ImClone Company Marks and ImClone Patent Rights, other thanImClone Core Patent Rights, including whether to initiate, defend or settlesuch Enforcement Actions, shall be made by ImClone.  ImClone shall have the exclusive right, usingcounsel selected by ImClone, to initiate or defend (as appropriate) and controlsuch Enforcement Actions.  UCB shall[***] [Confidential Treatment Required] cooperate, as requested by ImClone andat ImClone’s expense, with respect to such Enforcement Actions that relate toAntibody Products.  ImClone shall keepthe JPC informed of the progress of any such Enforcement Actions that relate toAntibody Products.  All expenses incurredand recoveries obtained in relation to any such Enforcement Action shall be[***] [Confidential Treatment Required].

 

#### (iii)                               UCB Core PatentRights and Product Trademarks for which UCB is the Product Trademark Owner

####  

As between the Parties, UCB shall with respectto UCB Core Patent Rights and Product Trademarks for which UCB is the ProductTrademark Owner during the Term have the first right and thereafter withrespect to UCB Core

 

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Patent Rights, the sole right, using outsidecounsel selected by UCB, to initiate or defend (as appropriate) and controlEnforcement Actions with respect to UCB Core Patent Rights and ProductTrademarks for which UCB is the Product Trademark Owner.  ImClone shall [***] [Confidential TreatmentRequired] cooperate, as requested by UCB, with respect to such EnforcementActions.  UCB shall keep the JPC informedof the progress of any such Enforcement Action. UCB shall keep the JPC advised of all communications, actual andprospective filings and submissions regarding any such Enforcement Action andshall provide the JPC with an opportunity to review and comment on any suchcommunications, filings and submissions. If UCB fails, during the Term, to institute or defend any suchEnforcement Action with respect to UCB Core Patent Rights or a ProductTrademark for which UCB is the Product Trademark Owner within [***][Confidential Treatment Required] after a written request by ImClone to do so,then ImClone, on written notice to UCB, shall have the right at its solediscretion to initiate or defend (as appropriate) and control such EnforcementAction in the name of either or both Parties *provided*that ImClone shall not settle or consent to a judgment in any such EnforcementAction if such settlement or judgment would have a material adverse effect onUCB unless approved by UCB [***] [Confidential Treatment Required].  If, after the Term, UCB fails to initiate ordefend any such Enforcement Action with respect to UCB Core Patent Rights, UCBshall have no right to initiate or defend and control such Enforcement Actionbut any [***] [Confidential Treatment Required].  All out of pocket expenses incurred inrelation to any Enforcement Action under this Article 10.7(b)(iii) shall be[***] [Confidential Treatment Required].

 

#### (iv)                              Other UCB PatentRights and UCB Company Marks

####  

All decisions relating to Enforcement Actionswith respect to UCB Company Marks and UCB Patent Rights, other than UCB CorePatent Rights, including whether to initiate, defend or settle such EnforcementActions, shall be made by UCB.  UCB shallhave the exclusive right, using counsel selected by UCB, to initiate or defend(as appropriate) and control such Enforcement Actions.  ImClone shall [***] [Confidential TreatmentRequired] cooperate, as requested by UCB and at UCB’s expense, with respect tosuch Enforcement Actions that relate to Antibody Products.  UCB shall keep the JPC informed of theprogress of any such Enforcement Actions that relate to Antibody Products.  All expenses incurred and recoveries obtainedin relation to any such Enforcement Action shall be [***] [ConfidentialTreatment Required].

 

#### (v)                                 Joint Patent Rights

####  

All decisions relating to Enforcement Actionswith respect to Joint Patent Rights shall be made by the JPC.  Upon the identification by a Party of anactual, alleged or threatened infringement or attack on the validity orenforceability of a Joint Patent Right, or upon a Party’s request to the JPC toconsider prosecuting or defending an Enforcement Action with respect to JointPatent Rights, the JPC shall: (i) promptly discuss such infringement, attackor Enforcement Action; (ii) promptly discuss the strategy for enforcing ordefending such Joint Patent Rights; and (iii) designate a Party (the **Responsible Party**) to be responsible for implementingthe decisions of the

 

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JPC with respect to such infringement, attackor Enforcement Action.  The ResponsibleParty shall, using outside counsel reasonably acceptable to both Parties,implement the decisions of the JPC regarding such Enforcement Action.  Save as provided in this Article 10.7(b)(v),all expenses incurred in relation to any such Enforcement Action shall be [***][Confidential Treatment Required].  Thenon-Responsible Party shall [***] [Confidential Treatment Required] cooperate,as requested by the JPC or the Responsible Party, in such Enforcement Action,including joining any such Enforcement Action. The Responsible Party shall keep the JPC informed of the progress of anysuch Enforcement Action.  The ResponsibleParty shall keep the JPC advised of all communications, actual and prospectivefilings or submissions regarding any such Enforcement Action, and provide theJPC with an opportunity to review and comment on any such communications,filing and submissions proposed to be made by the Responsible Party.  The Responsible Party shall not settle orconsent to a judgment in any such Enforcement Action with respect to JointPatent Rights, unless approved by the JPC [***] [Confidential TreatmentRequired].  Notwithstanding theforegoing, if a Party does not wish to [***] [Confidential Treatment Required]of prosecuting any such Enforcement Action, the other Party shall have theright to prosecute such Enforcement Action, through counsel of its choosing,without the consent of such first Party or the JPC, *provided* that the other Party shall [***] [ConfidentialTreatment Required].  If a Party electsto initiate or continue prosecuting an Enforcement Action as provided in thepreceding sentence, the other Party shall, and shall cause its Affiliates to,(x) [***] [Confidential Treatment Required] cooperate with such first Party inthis regard, and (y) promptly release or assign to the other Party, withoutconsideration, all right, title and interest in and to such Joint PatentRights.  For clarity, neither Party shallhave the right to not fund, or to cease defending, an Enforcement Actionbrought by a Third Party, except with respect to a counterclaim brought by aThird Party in connection with an Enforcement Action as to which such Partypreviously exercised its right not to fund.

 

## **10.8****                       ****Third Party Intellectual Property**

##  

### (a)                                  **JointlyIdentified Third Party Intellectual Property**

###  

If either Party believes that there exist ThirdParty intellectual property rights that are [***] [Confidential TreatmentRequired] to Develop, Commercialise or Manufacture an Antibody Product in theField then it shall notify the JPC, indicating in such notice whether or not aParty or any of its Affiliates have Control or have a right to acquire Controlof such Third Party intellectual property rights.  Each Party shall provide the JPC with suchdetails as it has and which it (without breaching any obligation it may have toa Third Party) is able to provide with respect to such Third Party intellectualproperty rights and of any right it or any of its Affiliates may have in or tothe same.  If the JPC determines thatsuch Third Party intellectual property rights are necessary or desirable toDevelop or Commercialise an Antibody Product in the Field, then the JPC shallinform the Collaboration Committee.  Ifthe Collaboration Committee approves the seeking of a licence, the Partiesshall use[***] [Confidential Treatment Required] to obtain such a licence undersuch Third Party intellectual property rights on such terms (economic orotherwise) as the Collaboration Committee determines,

 

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*provided* that theParties agree that they shall use [***] [Confidential Treatment Required] inthe first instance to obtain such a licence to be held by both Parties in theTerritory and if such licence is not obtainable on [***] [ConfidentialTreatment Required] terms, the Collaboration Committee shall designate oneParty to use [***] [Confidential Treatment Required] to obtain such a licencethroughout the Territory with the express right to grant a sublicence to theother Party as such sublicensing Party has with respect to its own intellectualproperty under Article 9.1.  No member ofthe Collaboration Committee shall [***] [Confidential Treatment Required] withholdits approval of a licence under Third Party intellectual property rights thatare [***] [Confidential Treatment Required] to Develop, Commercialise orManufacture an Antibody Product for an Agreed Indication in the Field.  If a Party (the first Party) (through theCollaboration Committee) does not agree that it is [***] [ConfidentialTreatment Required] to obtain such a licence to avoid infringing a ThirdParty’s Patent Rights, then the other Party shall be free to seek such licencewith respect to its own activities, with any costs with respect to such licence(to the extent disclosed to the JPC prior to obtaining the licence) to be [***][Confidential Treatment Required].  Ifthe first Party is subsequently sued by such Third Party for infringement ofsuch Third Party Patent; (i) any costs incurred in the defence or settlement ofsuch action, including any ongoing royalties, damages or other paymentobligations up to and including the amount that would have been payable to theThird Party had the first Party obtained the relevant licence shall be [***][Confidential Treatment Required], and (ii) any costs incurred in the defenceor settlement of such action, including any ongoing royalties, damages or otherpayment obligations in excess of that amount shall [***] [ConfidentialTreatment Required]. Notwithstanding the foregoing, the Continuing Party shallhave the right, [***] [Confidential Treatment Required] to obtain a licence toany Third Party intellectual property that relates solely to an IndependentIndication for which it is the Continuing Party without the consent of theother Party, the JPC or the Collaboration Committee and without securing anyexpress rights to sublicence to the other Party, unless and until suchIndependent Indication is Converted into a Converted Agreed Indication, *provided*that at the time the ContinuingParty identifies such Third Party intellectual property it shall notify theNon-Continuing Party in order to enable the Non-Continuing Party, at theNon-Continuing Party’s option, to negotiate a licence or option with respect tosuch Third Party intellectual property that would enable the Non-ContinuingParty to use such Third Party intellectual property in the event that suchIndependent Indication is subsequently Converted into a Converted AgreedIndication.  Each Party shall [***][Confidential Treatment Required] in relation to its own licence or option tosuch Third Party intellectual property, *provided*that, if the Continuing Party at the request of the Non-Continuing Partysecures an express right to sublicense to the Non-Continuing Party in itslicence to such Third Party intellectual property, the Non-Continuing Partyshall [***] [Confidential Treatment Required] by the Continuing Party inconnection with obtaining such right to sublicense *provided* that such [***] [Confidential Treatment Required]have been approved in advance by the Non-Continuing Party.  For clarity, the Continuing Party shall notbe obliged to enter into any such licence or option or obtain any such right tosublicense.

 

In addition, if a Party or any of itsAffiliates has the right to Control any such Third Party intellectual propertyrights specifically directed in substantial part to an Antibody Product thatare [***] [Confidential Treatment Required] to Develop an Antibody Product foran Agreed Indication in the Field, at the written request of the other Party,such Party shall exercise such right, with any costs with respect to such

 

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exercise (to the extent disclosed to the otherParty in writing prior to such request or otherwise agreed by the Parties) tobe [***] [Confidential Treatment Required] and such Third Party intellectualproperty right shall be included in the rights licensed pursuant to thisAgreement and the licence agreement pursuant to which such Control was acquiredshall be deemed to be an In-Licence and Part 1 or Part 2 of Schedule 1 shall bedeemed amended accordingly.

 

### (b)                                 **OtherThird Party Technology**

###  

In the event that UCB or ImClone (the **Acquiring Party**) proposes to apply to anAntibody Product technology that the Acquiring Party obtains from a ThirdParty, whether before or after the Effective Date, other than pursuant toArticle 10.8(a), the Acquiring Party shall disclose the same to theCollaboration Committee, including any royalty or other payment obligations toa Third Party determined in accordance with GAAP that would apply as a resultof the Development, Commercialisation or Manufacture of such Antibody Productsfor an Agreed Indication under this Agreement. The Collaboration Committee shall determine, within [***] [ConfidentialTreatment Required], whether or not the Collaboration Committee agrees thatsuch technology should be applied to such Antibody Product, and if theCollaboration Committee so determines that it should be, the agreement underwhich the Acquiring Party acquires such technology shall be deemed to be anIn-Licence and Part 1 or Part 2 of Schedule 1 shall be deemed amendedaccordingly, and any applicable corresponding royalty payments or obligationsshall be treated as [***] [Confidential Treatment Required].  If the Collaboration Committee fails to agreethat such technology should be applied to such Antibody Product, (i) thesubject matter of such agreement shall not be within the definition of UCBKnow-How, ImClone Know-How, UCB Patent Rights or ImClone Patent Rights underthis Agreement, (ii) the other Party shall have no licence or other rights withrespect to such technology, and (iii) to the extent a Party still wishes toapply such technology to an Antibody Product, it may do so [***] [ConfidentialTreatment Required].

 

### (c)                                  **ThirdParty Licences**

###  

Notwithstanding the provisions of this Article10, the rights and obligations of the Parties under this Article 10 shall besubject to the rights and obligations of the licensors under any In-Licences.

 

### (d)                                 **ThirdParty Patents**

###  

If a Third Party sues a Party alleging thatsuch Party’s or such Party’s Affiliates’, Distributors’ or sublicensees’Development, Commercialisation or Manufacturing activities (other than as aManufacturer, which shall be governed by the applicable ManufacturingAgreement) under this Agreement infringe or will infringe said Third Party’sPatent Rights or misappropriate said Third Party’s trade secret or said ThirdParty’s Trademark or other intellectual property, then the sued Party shallgive the other Party and the JPC prompt written notice thereof, and upon thesued Party’s request and in connection with such Party’s defence of any suchThird Party suit, the other Party shall provide [***] [Confidential TreatmentRequired] assistance to the sued Party for such defence and shall join suchsuit where required to do so under the Applicable Law.  The sued Party shall keep the JPC and theother Party, if such other Party has not joined in such suit, reasonablyinformed, in person or by telephone,

 

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prior to (if possible) and during the pendencyof any such suit.  The sued Party shall notadmit the invalidity, unenforceability or non-infringement of any Patent Rightslicensed under this Agreement or any infringement of a Third Party Patent inconnection with activities conducted under this Agreement nor settle any suchsuit, [***] [Confidential Treatment Required]. The [***] [Confidential Treatment Required] out of pocket litigationcosts and expenses incurred by each Party, including settlement costs,royalties paid in settlement of any such suit, and the payment of any damagesto the Third Party shall be [***] [Confidential Treatment Required].  Any amounts recovered from the Third Party byway of costs shall be [***] [Confidential Treatment Required].

 

## **10.9****                       ****Patent and Trademark Marking**

##  

To the extent practical and permitted byApplicable Law, each Territorial Lead shall mark Antibody Products sold in itsTerritory with all applicable patent numbers of Patent Rights of the Partiesand with notice of Trademark registrations in those countries in which suchmarkings have notice value as against infringers of Patent Rights orTrademarks.

 

## **10.10****                ****Allocation of Costs**

##  

### (a)                                  [***] [ConfidentialTreatment Required] **relating to Joint PatentRights**

###  

#### (i)                                     Subject to Article10.4(c), Article 10.5(e) and Article 10.7(b)(v), all [***] [Confidential TreatmentRequired] relating to Joint Patent Rights shall during the Term be [***][Confidential Treatment Required].

####  

#### (ii)                                  Followingtermination of this Agreement for any reason, each Party shall provide to theother within [***] [Confidential Treatment Required] of the end of eachCalendar Quarter a statement setting out the [***] [Confidential TreatmentRequired] in that Calendar Quarter in connection with Joint Patent Rightstogether with such evidence of such costs as the other Party may reasonablyrequire.  If and to the extent that oneParty has incurred more costs than the other Party, the other Party shallwithin [***] [Confidential Treatment Required].

####  

### (b)                                 [***] [ConfidentialTreatment Required]**relating to ImClone CorePatent Rights**

###  

All [***] [Confidential Treatment Required]relating to ImClone Core Patent Rights shall be included in the [***][Confidential Treatment Required].

 

### (c)                                  [***] [ConfidentialTreatment Required]**relating to UCB CorePatent Rights**

###  

All [***] [Confidential Treatment Required] relatingto UCB Core Patent Rights shall be included [***] [Confidential TreatmentRequired].

 

### (d)                                 [***] [ConfidentialTreatment Required]**relating to ProductTrademarks**

###  

All [***] [Confidential Treatment Required]relating to Product Trademarks shall be [***] [Confidential TreatmentRequired].

 

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### (e)                                  [***] [ConfidentialTreatment Required] **relating to other ImClonePatent Rights and ImClone Company Marks**

###  

[***] [Confidential Treatment Required]relating to ImClone Patent Rights (other than ImClone Core Patent Rights) andImClone Company Marks shall [***] [Confidential Treatment Required].

 

### (f)                                    [***] [ConfidentialTreatment Required] **relating to other UCBPatent Rights and UCB Company Marks**

###  

[***] [Confidential Treatment Required]relating to UCB Patent Rights (other than UCB Core Patent Rights) and UCBCompany Marks shall [***] [Confidential Treatment Required].

 

### (g)                                 **Recoveries**

###  

If and to the extent that either Party recoversany amount from a Third Party and the costs incurred in connection with suchrecovery constitute [***] [Confidential Treatment Required].  After termination of this Agreement anyrecoveries relating to actions relating to Joint Patent Rights that have beenjointly funded by the Parties shall be [***] [Confidential Treatment Required].

 

# **11.****                              ****CONFIDENTIALITY AND NON-USE**

# ** **

## **11.1****                       ****Confidentiality**

##  

Except as expressly set out in this Agreement,the Parties agree that, during the Term and for [***] [Confidential TreatmentRequired] following the date of expiration or termination of this Agreement,the receiving Party shall keep confidential and shall not publish or otherwisedisclose or use for any purpose other than as permitted under the terms of thisAgreement any Confidential Information of the other Party except to the extentthat it can be established by the receiving Party that such ConfidentialInformation:

 

### (a)                                  was already knownto the receiving Party, other than under an obligation of confidentiality, atthe time of disclosure by the other Party;

###  

### (b)                                 was generallyavailable to the public or otherwise part of the public domain at the time ofits disclosure to the receiving Party;

###  

### (c)                                  became generallyavailable to the public or otherwise part of the public domain after itsdisclosure and other than through any act or omission of the receiving Party inbreach of this Agreement;

###  

### (d)                                 was disclosed tothe receiving Party, other than under an obligation of confidentiality, by aThird Party who had no obligation to the disclosing Party not to disclose suchInformation to others; or

###  

### (e)                                  was independentlydeveloped by the receiving Party without use of the Confidential Information ofthe disclosing Party as demonstrated by competent written records.

 

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A Party’s Confidential Information shall not bedeemed to be within any of the foregoing exceptions merely because it isembraced by general disclosures within such exceptions, nor shall a Party’sConfidential Information be deemed to be within any of the foregoing exceptionsmerely because individual items are in such exceptions.

 

## **11.2****                       ****Authorised Disclosure**

##  

To the extent it is necessary or appropriate tofulfil its obligations or exercise its rights under this Agreement, a Party maydisclose such Confidential Information of the other Party as it is otherwiseobliged under Article 11.1 not to disclose:

 

### (a)                                  to its Affiliates,and to its and their (whether actual or potential) sublicensees, Distributors,consultants, outside contractors, Third Party Manufacturers and clinicalinvestigators, on a need-to-know basis and on the condition that such entitiesor persons, and their employees and agents, agree in writing to keep theConfidential Information confidential for the same time periods and to the sameextent as such Party is required to keep such Confidential Informationconfidential;

###  

### (b)                                 to RegulatoryAuthorities to the extent that such disclosure is [***] [Confidential TreatmentRequired] useful to obtain authorisations to conduct Clinical Studies or Post-ApprovalStudies or to file, obtain and maintain Regulatory Approvals and to Manufactureand Commercialise Antibody Product in the Field;

###  

### (c)                                  to the extent thatsuch disclosure is [***] [Confidential Treatment Required] useful in connectionwith preparing, filing, prosecuting, maintaining, enforcing and/or defendingUCB Core Patent Rights or ImClone Core Patent Rights or Joint Patent Rights inaccordance with the provisions of Article 10; or

###  

### (d)                                 in prosecuting ordefending litigation or in establishing rights or enforcing obligations underthis Agreement or in complying with Applicable Law, court or administrativeorders, the rules of any relevant stock exchange or similar governing body orthe U.S. Securities and Exchange Commission; *provided,however,* it shall:

###  

#### (i)                                     give reasonableadvance notice to the other Party of such disclosure requirement, to the extentpracticable;

####  

#### (ii)                                  provide a copy ofthe proposed disclosure to the other Party;

####  

#### (iii)                               only discloseConfidential Information of the other Party to the extent necessary; and

####  

#### (iv)                              at the request ofthe other Party, use [***] [Confidential Treatment Required] to secureconfidential treatment of such Confidential Information required to bedisclosed, including seeking a protective order, to the extent practicable.

 

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## **11.3****                       ****Public Announcements**

##  

Following the Effective Date, the Parties mayissue one or more press releases regarding this Agreement, the timing andcontent of which shall be mutually agreed to by the Parties.  Except to the extent required by ApplicableLaw or the rules of a relevant stock exchange or similar governing body or asotherwise permitted in accordance with this Article 11, neither Party shallmake any further public announcements concerning this Agreement or the subjectmatter of this Agreement without the prior written consent of the other, [***][Confidential Treatment Required].  TheParties agree to consult with each other reasonably and in good faith withrespect to the text and timing of any press releases prior to its issuance.

 

## **11.4****                       ****Third Party Obligations**

##  

Neither Party is obliged to disclose to theother Party any Information that it receives from a Third Party if to do sowould put the disclosing Party in breach of an obligation owed to such ThirdParty.

 

## **11.5****                       ****Termination of Prior Confidentiality Agreements**

##  

This Agreement supersedes the ConfidentialityAgreement between the Parties dated March 17, 2004.  All Confidential Information (as defined insuch Confidentiality Agreement as amended and extended) disclosed by a Party tothe other Party under such Confidentiality Agreement shall be deemed to be theConfidential Information of that disclosing Party under this Agreement andshall be subject to the terms of this Article 11.

 

## **11.6****                       ****Publications**

##  

### (a)                                  The CollaborationCommittee (or its appropriate designees) shall determine the strategy for, andcoordinate, the publication and presentation of results of studies of AntibodyProducts or other data generated under this Agreement.  Where the Collaboration Committee appoints adesignee to carry out this function, the designee shall submit such strategy tothe Collaboration Committee for approval.

###  

### (b)                                 Each Partyrecognises that the publication of papers regarding results of and otherinformation regarding activities under this Agreement, including oralpresentations and abstracts, may be beneficial to both Parties, *provided* such publications are subject toreasonable controls to protect Confidential Information.  In particular, it is the intent of theParties to maintain the confidentiality of any Confidential Informationincluded in any patent application until such patent application has beenpublished.  Accordingly, each Party willhave the right to review and approve any paper proposed for publication by theother Party, including any oral presentation or abstract, which incorporatesdata generated under this Agreement or which includes Confidential Informationof the other Party.  Before any suchpaper is submitted for publication or an oral presentation is made, thepublishing or presenting Party shall deliver a complete copy of the paper ormaterials for oral presentation to the other Party at least [***] [ConfidentialTreatment Required] prior to submitting the paper to a publisher or making the

 

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presentation. The other Party shall review any such paper and give its comments to thepublishing Party within [***] [Confidential Treatment Required] of the deliveryof such paper to the other Party.  Withrespect to oral presentation materials and abstracts, the other Party shallmake [***] [Confidential Treatment Required] to expedite review of suchmaterials and abstracts, and shall return such items [***] [ConfidentialTreatment Required] to the publishing or presenting Party with appropriatecomments, if any, but in no event later than [***] [Confidential TreatmentRequired] from the date of delivery to the other Party.  Failure to respond within such [***][Confidential Treatment Required] shall be deemed approval to publish orpresent.  During the Term, if approval isnot given or deemed given, either Party may refer the matter to theCollaboration Committee for resolution together with the reasons forwithholding approval.  Notwithstandingthe foregoing, the publishing or presenting Party shall, if and to the extentconsistent with Applicable Law and industry standards, comply with the otherParty’s request to delete references to such other Party’s ConfidentialInformation in any such paper and will withhold publication of any such paperor any presentation of same for an additional [***] [Confidential TreatmentRequired] in order to permit the Parties to obtain patent protection if eitherParty deems it necessary.  Any publicationshall include recognition of the contributions of the other Party according tostandard practice for assigning scientific credit, either through authorship oracknowledgement, as may be appropriate. Each Party shall use [***] [Confidential Treatment Required] to causeinvestigators and institutions participating in Clinical Studies andPost-Approval Studies with which it contracts to agree to terms substantiallysimilar to those set forth in this Article 11.6, which [***] [ConfidentialTreatment Required] shall satisfy such Party’s obligations under this Article11.6 with respect to such investigators and institutions.

###  

# **12.****                              ****TERM AND TERMINATION**

# ** **

## **12.1****                       ****Term of this Agreement**

##  

Unless earlier terminated pursuant to thisArticle 12, this Agreement shall become effective on the Effective Date andshall remain in full force and effect on a [***] [Confidential TreatmentRequired], *provided* that ifAntibody Products are only being Developed or Commercialised for IndependentIndications and if there is only one Continuing Party, then if, within [***][Confidential Treatment Required] after its election to withdraw with respectto the last Agreed Indication for an Antibody Product pursuant to Article 8.1,the Non-Continuing Party has not provided the Continuing Party with an OptionExercise Notice with respect to at least one Independent Indication for anAntibody Product pursuant to Article 8.9, the Non-Continuing Party shall bedeemed to have terminated this Agreement pursuant to Article 12.2 and suchNon-Continuing Party shall be the Terminating Party and the Continuing Partyshall be the Remaining Party as provided therein.

 

## **12.2****                       ****Voluntary Termination of this Agreement**

##  

Subject to Article 16.1, either Party (the **Terminating Party**) shall have the right atany time to terminate this Agreement in its entirety by giving written noticeof termination of this Agreement to the other Party.  If within [***] [Confidential

 

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Treatment Required] of receipt of such terminationnotice, the other Party provides the Terminating Party with written notice thatit wishes to continue Development and Commercialisation (as appropriate) of oneor more Antibody Products (whether in Agreed Indications or IndependentIndications), the other Party shall be deemed to be the Remaining Party and theTerminating Party shall be deemed the Non-Remaining Party for purposes of thisArticle 12 and termination shall take effect upon expiry of the TransitionPeriod.  If the other Party does notserve such written notice within [***] [Confidential Treatment Required] ofreceipt of such termination notice, the Parties shall cease all activitiesunder this Agreement as expeditiously and as cost effectively as possible withdue regard for patient safety and the rights of any subjects that areparticipants in Clinical Studies or Post-Approval Studies and in compliancewith Applicable Law and this Agreement shall terminate on the date on which allsuch activities cease and in such circumstances this Agreement shall beterminated only under this Article 12.2, and no other Article.

 

## **12.3****                       ****Termination with respect to Competing Products**

##  

### (a)                                  Subject to Article16.2 and Article 16.4, but without prejudice to any other remedy a Party mayhave, a Party (which Party shall be deemed to be the Remaining Party) mayterminate this Agreement by giving written notice of termination to the otherParty (which party shall be deemed to be the Non-Remaining Party or, for thepurposes of this Article 12.3, the **ExcludedParty**) if the Excluded Party or any of its Affiliates [***][Confidential Treatment Required] (as such terms are defined in this Agreement,except for purposes of this Article 12.3, the term “Antibody Product” as itappears in any definition of a defined term included in such definitions of“Clinical Study”, “Development” or “Commercialises” shall be deemed to bereplaced with the term “Antibody Product or Competing Product, as applicable”),alone or in collaboration with a Third Party, a Competing Product (a **Competing Activity**).  Such notice of termination shall take effectin accordance with Article 12.3(c).

###  

### (b)                                 If the MergingParty:

###  

#### (i)                                     fails to notify theother Party of its intention to take one of the actions described in paragraphs(x) through (z) of Article 16.4 within the [***] [Confidential TreatmentRequired] provided for in Article 16.4;

####  

#### (ii)                                  timely notifies theother Party of its intention to terminate this Agreement but fails to serve anotice of termination pursuant to Article 12.2 within [***] [ConfidentialTreatment Required] of notifying the other Party of such intention;

####  

#### (iii)                               timely notifies theother Party of its intention to divest such Competing Product but fails to useall [***] [Confidential Treatment Required] to effect such divestment as quicklyas possible in accordance with Article 16.4(b); or

####  

#### (iv)                              timely notifies theother Party of its intention to cease all Competing Activities but does notcease all Competing Activities as expeditiously as possible in accordance withArticle 16.4(a),

 

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the other Party (which Party shall be deemed tobe the Remaining Party) may, on written notice to the Merging Party, inaddition to any other remedies available to it at law or equity, terminate thisAgreement by giving written notice of termination to the other Party.  Such notice of termination shall take effectin accordance with Article 12.3(c).

 

### (c)                                  Any notice oftermination served pursuant to Article 12.3(a) or (b) shall specify whether theRemaining Party wishes to continue Development or Commercialisation (asappropriate) of one or more Antibody Products (whether in Agreed Indications orIndependent Indications).  If theRemaining Party does not wish to continue any such Development orCommercialisation of Antibody Products, upon service of the notice oftermination, the Parties shall cease all activities under this Agreement asexpeditiously and as cost effectively as possible with due regard for patientsafety and the rights of any subjects that are participants in Clinical Studiesor Post-Approval Studies and in compliance with Applicable Law.  If the Remaining Party wishes to continue anysuch Development or Commercialisation of Antibody Products, Article 12.8 shallapply and termination shall take effect on expiry of the Transition Period.

###  

### (d)                                 For clarity, thisArticle 12.3 shall not apply to ImClone’s (or one of its Affiliate’s)development programme in respect of one or more Antibodies, including 1121B,any of which is or may be a Competing Product or otherwise competitive with anAntibody Product, prior to the date, if any, that ImClone elects to cease suchCompeting Activities pursuant to Article 16.2(b).

###  

## **12.4****                       ****Termination for Default**

##  

### (a)                                  In the event that(i) any representation or warranty made under this Agreement by a Party shallhave been untrue in any material respect and this untruth has a material andadverse effect on the other Party in relation to this Agreement, or (ii) thereis a material breach or material default of this Agreement by a Party (anyevent under (i) or (ii), a **Default**),then the Party not in default (the **Non-DefaultingParty**) shall have the right to give the other Party (the **Defaulting Party**) written notice (a **Notice of Default**), which notice, to beeffective, must state the nature of the Default in reasonable detail and mustrequest that the Defaulting Party cure such Default within [***] [ConfidentialTreatment Required] of the date of such notice (or [***] [ConfidentialTreatment Required] of the date of such notice with respect to a paymentDefault ) or such longer period as the Non-Defaulting Party may designate insuch notice (the **Cure Period**).  During any such Cure Period or any extendedperiod in which the Defaulting Party seeks to cure the Default in accordance withArticle 12.4(c), all of each Party’s respective rights and obligations underthis Agreement, including those in relation to Development, Commercialisationand Manufacture, shall (to the extent applicable) remain in force and effect.

###  

### (b)                                 The Cure Periodwith respect to a Default shall commence on the date that the Defaulting Partyreceives the Notice of Default with respect thereto.

###  

### (c)                                  If a Default is notcured within the applicable Cure Period (or, if such Default cannot be cured insuch Cure Period and if the Defaulting Party has not used

 

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[***] [Confidential Treatment Required] to curesuch Default within such period and thereafter diligently continues suchactions, *provided* that paymentDefaults must be cured within the Cure Period), the Non-Defaulting Party, atits option, may immediately serve written notice on the Defaulting Partyterminating this Agreement, such termination to take effect in accordance withArticle 12.4(d).

###  

### (d)                                 Any notice of terminationserved pursuant to Article 12.4(c), shall specify whether the Non-DefaultingParty wishes to continue Development or Commercialisation (as appropriate) ofone or more Antibody Products (whether in Agreed Indications or IndependentIndications).  If the Non-DefaultingParty does not wish to continue any such Development or Commercialisation ofAntibody Products, upon the notice of termination taking effect, the Partiesshall cease all activities under this Agreement as expeditiously and as cost effectivelyas possible with due regard for patient safety and the rights of any subjectsthat are participants in Clinical Studies or Post-Approval Studies and incompliance with Applicable Law and this Agreement shall terminate on the dateon which all such activities cease.  Ifthe Non-Defaulting Party (which Party shall be deemed to be the RemainingParty) wishes to continue Development or Commercialisation of AntibodyProducts, Article 12.8 shall apply, termination shall take effect upon expiryof the Transition Period and the Defaulting Party shall be deemed to be theNon-Remaining Party.

###  

## **12.5****                       ****Termination for Bankruptcy**

##  

### (a)                                  All rights andlicences granted under or pursuant to this Agreement by ImClone or UCB are, andshall otherwise be deemed to be, licences of rights to “intellectual property”as defined under bankruptcy laws, rules and regulations in the Territory,including as defined under Article 101 of the United States BankruptcyCode.  The Parties agree that theRemaining Party (as defined in Article 12.5(b)) shall retain and may fullyexercise all of its rights and elections under bankruptcy laws, rules,regulations or statutes in the Territory, including the United StatesBankruptcy Code.  The Parties furtheragree that, in the event of the commencement of a bankruptcy proceeding by oragainst a bankrupt Party the other Party shall be entitled to a completeduplicate of (or complete access to, as appropriate) any intellectual propertywhich at that date is known to be necessary or useful to the Development,Commercialisation, Manufacturing or other exploitation of the Antibody Productsand all embodiments of such intellectual property; and the same, if not alreadyin the other Party’s possession, shall be promptly delivered to the otherParty: (i) upon any such commencement of a bankruptcy proceeding, upon theother Party’s written request for the same, unless the non-bankrupt Party (or atrustee on behalf of the bankrupt Party) elects within [***] [ConfidentialTreatment Required] to continue to perform all of its obligations under thisAgreement; or (ii) if not delivered under (a) above, upon the rejection of thisAgreement by or on behalf of the bankrupt Party, upon written request for thesame by the other Party.

###  

### (b)                                 Without prejudiceto Article 12.5(a), this Agreement may be terminated by a Party (which Partyshall be deemed to be the Remaining Party) upon prior

 

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written notice to the other Party (which Partyshall be deemed to be the Non-Remaining Party) in the event that:

###  

#### (i)                                     the other Partyshall make an assignment for the benefit of its creditors, file a petition inbankruptcy, petition or apply to any tribunal for the appointment of custodian,receiver or any trustee for it or a substantial part of its assets, or shallcommence any proceeding under any bankruptcy, reorganisation, arrangement,readjustment of debt, dissolution or liquidation law, rule, regulation orstatute of any jurisdiction (other than for the purposes of a solvent amalgamationor reconstruction), in effect from time to time; or

####  

#### (ii)                                  if there shall havebeen filed against the other Party any such bona fide petition or application,or any such proceeding shall have been commenced against it, in which an orderfor relief is entered or which remains undismissed for a period of [***][Confidential Treatment Required] or more; or

####  

#### (iii)                               if the other Partyby any act or omission shall indicate its consent to, approval of oracquiescence in any such petition, application or proceeding or order forrelief or the appointment of a custodian, receiver or trustee for it or anysubstantial part of its assets, and shall suffer any such custodianship,receivership or trusteeship to continue undischarged for a period of [***][Confidential Treatment Required] or more (each of (i), (ii) and (iii), an **Insolvency Event**).

####  

Notwithstanding the foregoing, this Agreementshall not be terminated pursuant to this Article 12.5(b) if, within [***][Confidential Treatment Required]of receipt of the termination notice describedin this Article 12.5(b), the Party experiencing the Insolvency Eventdemonstrates to the other Party that it is not insolvent.  Any notice of termination served pursuant tothis Article 12.5(b) shall specify whether the Remaining Party wishes tocontinue Development or Commercialisation (as appropriate) of one or moreAntibody Products, (whether in Agreed Indications or IndependentIndications).  If the Remaining Partydoes not wish to continue any such Development or Commercialisation of AntibodyProducts, upon receipt of the notice of termination by the other Party, theParties shall cease all activities under this Agreement as expeditiously and ascost effectively as possible with due regard for patient safety and the rights ofany subjects that are participants in Clinical Studies or Post-Approval Studiesand this Agreement shall terminate on the date on which all such activitiescease.  If the Remaining Party wishes tocontinue Development or Commercialisation of Antibody Products, Article 12.8shall apply and termination shall take effect upon expiry of the TransitionPeriod.

 

## **12.6****                       ****Termination for Challenging Validity of Core Patents**

##  

In the event that a Party or any of itsAffiliates (the **Challenging Party**)challenges the validity or enforceability of any of the other Party’s CorePatent Rights, then the Party whose Core Patent Rights are the subject of thechallenge (the **Non-Challenging Party**)may give the Challenging Party written notice of its intention to

 

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terminate this Agreement if the ChallengingParty does not withdraw its challenge within [***] [Confidential TreatmentRequired] after delivery of such notice. If the Challenging Party has not withdrawn its challenge to the validityor enforceability of the Non-Challenging Party’s Core Patent Rights by the endof that [***] [Confidential Treatment Required] period, the Non-ChallengingParty may, at its option, terminate this Agreement upon prior written notice tothe Challenging Party.  Upon terminationof this Agreement pursuant to this Article 12.6, the Non-Challenging Partyshall be deemed to be the Remaining Party and the Challenging Party shall bedeemed to be the Non-Remaining Party. Any notice of termination served pursuant to this Article 12.6 shallspecify whether the Remaining Party wishes to continue Development orCommercialisation (as appropriate) of one or more Antibody Products (whether inAgreed Indication or Independent Indications). If the Remaining Party does not wish to continue any such Development orCommercialisation of Antibody Products, upon the notice of termination takingeffect, the Parties shall cease all activities under this Agreement asexpeditiously and as cost effectively as possible having due regard for patientsafety and the rights of any subjects that are participants in Clinical Studiesor Post-Approval Studies and in compliance with Applicable Law and thisAgreement shall terminate on the date on which all such activities cease.  If the Remaining Party wishes to continueDevelopment or Commercialisation of Antibody Products, Article 12.8 shall applyand termination shall take effect upon expiry of the Transition Period.

 

## **12.7****                       ****Remedies**

##  

The Parties acknowledge and agree thattermination as provided in this Article 12 is not the exclusive remedy for anymatter underlying a right of termination, but rather remedies are cumulative.

 

## **12.8****                       ****Consequences of Termination**

##  

### (a)                                  Upon notice oftermination of this Agreement being given under Articles 12.2, 12.3, 12.4, 12.5or 12.6 where there is a Remaining Party (as defined in the applicable Article)that wishes to continue with the Development or Commercialisation of anyAntibody Products, the following terms shall apply:

###  

#### (i)                                     The CollaborationCommittee shall promptly meet to devise a transition plan (**Transition Plan**) which provides for aprompt, smooth, orderly and cost-effective transition of, and which sets forththe responsibilities and a timetable for transferring, all Development andCommercialisation and Manufacturing (to the extent applicable) responsibilitiesto the Remaining Party, including those activities set forth in paragraphs (ii)to (xi) of this Article 12.8(a).  Wherethe Collaboration Committee cannot agree on the Transition Plan the mattershall be resolved pursuant to the dispute resolution process set forth inArticle 15, *provided* that, exceptas otherwise provided in this Article 12.8 or elsewhere in this Agreement, theNon-Remaining Party shall not be required to perform any Development,Commercialisation or Manufacturing activities beyond those assigned to it inthe Development Plan, the Commercialisation Plan or the Manufacturing Plan andin no event shall the Non-Remaining Party be required to incur any expensesbeyond those set forth in the applicable Development Budget, the CommercialisationBudget or Manufacturing

 

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Plan. Except as otherwise agreed by the Parties or as provided in this Article12.8(a), such transition shall be completed as soon as practicable and, in anyevent, shall be no later than [***] [Confidential Treatment Required] from thedate of the relevant termination notice (the **TransitionPeriod**), except with respect to any Manufacturing activitiesperformed by or on behalf of the Non-Remaining Party, which shall continueafter the Transition Period as provided in Article 12.8(a)(vii) and (viii) andthe applicable Manufacturing Agreement or existing supply agreement listed inSchedule 4.  Such Transition Plan shallprovide for (1) transferring all Development, Manufacturing andCommercialisation responsibilities to the Remaining Party in all AgreedIndications and Independent Indications (all such Agreed Indications andIndependent Indications, the **Continuing Indications**),and (2) ceasing all Development, Commercialisation and Manufacturing activitiesin relation to any Continuing Indications that the Remaining Party wishes todiscontinue, in each case as expeditiously as possible in accordance with thisArticle 12 whilst (where appropriate) maintaining a supply of Antibody Productsto meet Development and Commercialisation requirements and minimisinginterruption of Development, Commercialisation and Manufacture of AntibodyProducts in the relevant Indications.

####  

#### (ii)                                  Until the end ofthe Transition Period (and with respect to Manufacturing by the Non-RemainingParty as provided in paragraph (i) above), the Non-Remaining Party, [***][Confidential Treatment Required], shall make its personnel and other resources[***] [Confidential Treatment Required] available to the Remaining Party as[***] [Confidential Treatment Required] and shall, by the end of the TransitionPeriod (and with respect to Manufacturing by the Non-Remaining Party asprovided in paragraph (i) above), transfer copies of all relevant information,files or data relating to the Antibody Products to the Remaining Party andassign to the Remaining Party or its designee all rights, title and interesttherein.

####  

#### (iii)                               By the end of theTransition Period (and with respect to Manufacturing by the Non-Remaining Partyas provided in paragraph (i) above), the Non-Remaining Party, [***][Confidential Treatment Required], shall assign and transfer to the RemainingParty all of its rights, title or interest in or to any regulatory filings andRegulatory Approvals then in its name (or in the name of any of its Affiliates,or, unless otherwise agreed by the Parties, in the name of any of itssublicensees or Distributors or any of their agents) for Antibody Product forthe Continuing Indications (including all INDs and Drug Approval Applications)and shall notify the appropriate Regulatory Authorities and take any otheraction [***] [Confidential Treatment Required] to effect such assignment.  The Remaining Party shall take all actions[***] [Confidential Treatment Required] to assist in effecting such assignmentand transfer.  If ownership of aregulatory submission or Regulatory Approval cannot be transferred to theRemaining Party in any country, the Non-Remaining Party, [***] [ConfidentialTreatment

 

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Required], shall and does hereby grant andshall cause its Affiliates, and, unless otherwise agreed by the Parties, itssublicensees and Distributors to grant to the Remaining Party a [***][Confidential Treatment Required] licence and right of access, reference anduse to such regulatory submission and Regulatory Approvals for all purposes inthe Field in such country.  If such licenceand right of access, reference and use is not sufficient to permit theRemaining Party to file a Drug Approval Application and receive RegulatoryApproval or to Develop, use, sell, have sold, offer to sell, resell, import,export, distribute or otherwise transfer possession of or otherwiseCommercialise or Manufacture the relevant Antibody Product for all purposes inthe Field, or as otherwise requested by the Remaining Party, the Non-RemainingParty, [***] [Confidential Treatment Required], shall provide the RemainingParty with the complete data package, including any data referenced therein,that the Non-Remaining Party, its Affiliates or their Distributors orsublicensees used in regulatory submissions in such country (including INDs,Drug Approval Applications and any other filings to or with the applicableRegulatory Authorities) in order to allow the Remaining Party or its designeeto file such IND and Drug Approval Application and to receive RegulatoryApproval in its or such designee’s own name.

####  

#### (iv)                              By the end of theTransition Period the Non-Remaining Party shall, at the request of theRemaining Party, assign its rights or grant sufficient and, to the extentpossible, [***] [Confidential Treatment Required], under all of theNon-Remaining Party’s rights under any then-existing In-Licences to the extentthe same relates to Developing, Commercialising, Manufacturing, making, havingmade, using, selling, having sold, offering to sell or resell, importing,exporting, distributing or otherwise transferring physical possession of or otherwisetransferring title in or to Antibody Products in the Field and shall not (untilreceiving notice that the Remaining Party does not desire such an assignment orsublicence) terminate or amend any such In-Licence without the RemainingParty’s prior written consent.  Untilreceiving notice that the Remaining Party does not desire an assignment orsublicence of an In-Licence, the Non-Remaining Party shall continue to complywith its obligations under Article 9.3 with respect to each such In-Licence.

####  

#### (v)                                 Each Party, [***][Confidential Treatment Required], shall destroy or at the other Party’srequest return, all of the other Party’s Confidential Information (other thanwith respect to maintaining one (1) archival copy of Confidential Informationrelating to any of the same for its legal files, for the sole purpose ofdetermining its obligations under this Agreement) and Materials and shallprovide the other Party with certification by one of its officers that all suchConfidential Information and Materials have been destroyed or returned to theother Party, as appropriate, *provided*that the Remaining Party shall be entitled to retain all of the Non-RemainingParty’s Confidential Information and Materials that are [***] [ConfidentialTreatment

 

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Required] to Develop, Commercialise orManufacture Antibody Products in the Field in the Territory.

####  

#### (vi)                              The Non-RemainingParty, [***] [Confidential Treatment Required], shall, at the request andexpense of the Remaining Party, provide the Remaining Party with suchassistance as is [***] [Confidential Treatment Required] to effectuate a smoothand orderly transition of any such Development, Manufacture andCommercialisation activities to the Remaining Party or its designee so as tominimize any disruption of such activities, including, at the request of theRemaining Party, the assignment (and assumption by the Remaining Party) of anysuch Regulatory Approvals and related regulatory documentation and contractsand the transfer of any such biological materials related to any AntibodyProduct, in each case that is the subject of such obligation.  Further, upon the Remaining Party’s request,the Non-Remaining Party shall provide such technical assistance, [***][Confidential Treatment Required], as may [***] [Confidential TreatmentRequired]be requested to transfer all manufacturing technology that is or hadbeen used by or on behalf of the Non-Remaining Party and its Affiliates inconnection with the Manufacture, including process development, of any AntibodyProduct.

####  

#### (vii)                           If theNon-Remaining Party is Manufacturing any Antibody Products it shall continue tosupply the Antibody Products it is then manufacturing to the Remaining Party onthe same terms as applied prior to termination until the earlier of [***][Confidential Treatment Required] from the date of termination or such time asthe Remaining Party or a Third Party designated by the Remaining Party assumesresponsibility for Manufacture of such Antibody Products, which it shall havethe right to do, save that the [***] [Confidential Treatment Required]; duringthe period of Manufacture by the Non-Remaining Party, the Remaining Party shallbe deemed to have automatically granted to the Non-Remaining Party a [***] [ConfidentialTreatment Required] right and licence, to use (y) any Joint Know-How or JointPatent Rights and (z) if the Non-Remaining Party is (1) UCB, to use any ImCloneKnow How, ImClone Patent Rights, Manufacturing Know How (to the extentControlled by ImClone) and Manufacturing Patents (to the extent Controlled byImClone) and (2) ImClone, to use any UCB Know-How and UCB Patent RightsManufacturing Know How (to the extent Controlled by UCB) and ManufacturingPatents (to the extent Controlled by UCB) , in each case ((y) and (z)) as [***][Confidential Treatment Required] to (and only to) Manufacture and supply suchAntibody Products to the Remaining Party as provided herein.

####  

#### (viii)                        If a Third Party supplier isManufacturing any Antibody Products, then the Non-Remaining Party, [***][Confidential Treatment Required], shall, at the request of the RemainingParty, use all [***] [Confidential Treatment Required] to assign to theRemaining Party, and upon such assignment, the Remaining Party shall assume,any applicable

 

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manufacturing agreement and the Non-RemainingParty[***] [Confidential Treatment Required], shall cooperate with theRemaining Party at the Remaining Party’s request to participate in any discussionswith such Third Party supplier with respect to such assignment (and assumption)or the negotiation of any direct agreement with a Third Party supplier, *provided* that, (x) to the extent theRemaining Party receives the benefit of any existing Third Party ManufacturingAgreement or existing supply agreement listed in Schedule 4, the RemainingParty shall be [***] [Confidential Treatment Required] to the Remaining Partyand (y) if the Remaining Party requests that the Non-Remaining Party terminateany such agreement with a Third Party supplier, the Remaining Party shall beresponsible for [***] [Confidential Treatment Required] to such Third Partysupplier.  In any event the Non-RemainingParty, [***] [Confidential Treatment Required], shall, at the request of theRemaining Party, (1) effect a smooth and orderly transition of allManufacturing responsibilities to the Remaining Party or its designee, and (2)cooperate with the Remaining Party or its designee in the conduct of any suchManufacturing responsibilities and the exercise of its rights under thisAgreement, such as, for example, exercising any right or enforcing anyobligation under any Manufacturing Agreement with a Third Party supplier andproviding the Remaining Party or its designee with any copies of relevantdocuments (including Manufacturing Know How (to the extent within the Controlof the Non-Remaining Party), quantities of all Materials (including master cellbank) and rights of reference, as necessary to allow the Remaining Party to exerciseits rights under this Agreement.

####  

#### (ix)                                The Non-RemainingParty,[***] [Confidential Treatment Required], shall:  (y) to the extent permitted by suchagreements, use all [***] [Confidential Treatment Required] to assign itsrights or grant sufficient rights under all other Third Party agreements to theextent the same relate to an Antibody Product as requested to do so by theRemaining Party and, upon such assignment, the Remaining Party shall assumesuch agreements; and (z) provide [***] [Confidential Treatment Required]assistance to the Remaining Party to assume management of such agreements.

####  

#### (x)                                   Each Party shallretain the audit rights specified under this Agreement to the extent reasonablyrequired to verify the correctness of any amounts payable to it under thisAgreement.

####  

#### (xi)                                The Remaining Partyshall bear all [***] [Confidential Treatment Required].

####  

### (b)                                 The Non-RemainingParty shall not be considered in breach of this Article 12 to the extent itfails to fulfil its obligations under this Article 12.8 because of aninjunction imposed by a court of law arising from an action brought by a ThirdParty for infringement of Third Party Patent Rights, Third Party Trademarkrights or other Third Party intellectual property rights, except to the extent thatsuch injunction results from a breach of the Non-Remaining Party’s

 

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representations and warranties under Article 13or, if the Non-Remaining Party is a Manufacturer, a breach of the Non-RemainingParty’s representations and warranties under any Manufacturing Agreement.

###  

### (c)                                  Upon termination ofthis Agreement for any reason, all of the right, title and interest of theNon-Remaining Party and its Affiliates in the Product Trademarks shallautomatically be assigned, [***] [Confidential Treatment Required], to theRemaining Party.  The Remaining Partyshall also have the right, for a reasonable period not to exceed [***][Confidential Treatment Required] from the end of the Transition Period, to usethe ImClone Company Marks (if the Remaining Party is UCB) or the UCB CompanyMarks (if the Remaining Party is ImClone), as applicable, solely in the sellingof any existing inventory of Antibody Products and using any existing inventoryof Promotional Materials and packaging, [***] [Confidential TreatmentRequired], and following the expiration of such [***] [Confidential TreatmentRequired] period such inventory shall be destroyed by the Remaining Party, theRemaining Party shall certify such destruction to the Non-Remaining Party andthe Remaining Party shall immediately cease all use of the Non-RemainingParty’s Corporate Marks in connection with Antibody Products.  In addition:

###  

#### (i)                                     Upon termination ofthis Agreement where ImClone is the Remaining Party, (A) each of the licencesUCB granted to ImClone pursuant to this Agreement (save for those with respectto the UCB Company Marks) shall automatically upon termination convert to a[***] [Confidential Treatment Required].

####  

#### (ii)                                  Upon termination ofthis Agreement where UCB is the Remaining Party, (A) each of the licencesImClone granted to UCB pursuant to this Agreement (save for those with respectto the ImClone Company Marks) shall automatically upon termination convert to a[***] [Confidential Treatment Required].

####  

#### (iii)                               Upon termination ofthis Agreement, if on or before a termination the Non-Remaining Party granted asublicence as permitted by Article 9.5 and the applicable sublicensee is not inbreach of its obligations under such sublicence agreement, the sublicenceagreement shall, if the Remaining Party so elects and the sublicence agreementso permits, be deemed to be a sublicence agreement between the Remaining Partyand the sublicensee.

####  

## **12.9****                       **[***][Confidential Treatment Required]

##  

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## **12.10****                ****Additional Termination Consequences in the Event ofTermination under Certain Articles**

##  

### (a)                                  In the event oftermination of this Agreement under any Article, (i) not later than [***][Confidential Treatment Required] after the date on which such terminationtakes effect, the Parties will reconcile Operating Profits and Losses andpromptly make such payments as are necessary to effect such reconciliation, and(ii) the Non-Remaining Party shall cease to have any right or, except asprovided in Article 12.8 or elsewhere in this Agreement or in a TransitionPlan, obligation to fund or participate in the Development of any AntibodyProduct and shall have no right or obligation to share in any Operating Profitsand Losses, [***] [Confidential Treatment Required].

###  

### (b)                                 Followingtermination of this Agreement pursuant to Articles 12.2, 12.3, 12.4 or 12.6, ifthe Non-Remaining Party materially breaches the terms of any licence granted bythe Non-Remaining Party to the Remaining Party under Article 12.8(c), theRemaining Party may, by written notice to the Non-Remaining Party, require theNon-Remaining Party to remedy that breach and, if such breach has not beenremedied within [***] [Confidential Treatment Required] of receipt of suchwritten notice, the Remaining Party may, by notice in writing to the RemainingParty, [***] [Confidential Treatment Required].

###  

### (c)                                  Followingtermination of this Agreement pursuant to any Article, if the Remaining Partyor any of its Affiliates challenges the validity or enforceability of any ofthe Non-Remaining Party’s Core Patent Rights or takes the position that theDevelopment, Manufacture or Commercialisation of Antibody Product falls outsidethe claims of the Non-Remaining Party’s Core Patent Rights, then theNon-Remaining Party may give the Remaining Party written notice of itsintention to terminate the licences granted by the Non-Remaining Party pursuantto this Agreement if the Remaining Party does not withdraw its challenge orposition within sixty (60) day after delivery of such notice.  If the Remaining Party has not withdrawn itschallenge to the validity or enforceability of, or its position with respectto, the Non-Remaining Party’s Core Patent Rights by the end of that sixty (60)day period, the Non-Remaining Party may, at its option, terminate all licencesgranted by the Non-Remaining Party to the Remaining Party pursuant to thisAgreement upon prior written notice to the Remaining Party.  Upon such notice the Remaining Party shallcease all activities being conducted under those licences as expeditiously aspossible having due regard for patient safety and the rights of

 

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any subjects that are participants in ClinicalStudies or Post-Approval Studies and in compliance with Applicable Law.

###  

## **12.11****                ****Surviving Rights**

##  

### (a)                                  Expiration ortermination of this Agreement shall not relieve the Parties of any obligationaccruing before such expiration or termination. Any expiration or termination of this Agreement shall be withoutprejudice to the rights of either Party against the other accrued or accruingunder this Agreement before expiration or termination, including the right toreceive any payments due but unpaid before expiration or termination.

###  

### (b)                                 The followingArticles shall survive expiration or termination of this Agreement, howsoevercaused: [***] [Confidential Treatment Required] to the extent applicable toactivities occurring before or surviving termination and any other provisionswhich are expressed to survive expiration or termination or which are requiredto give effect to such expiration or termination.  The [***] [Confidential TreatmentRequired].  All other rights andobligations shall terminate.

###  

# **13.****                              ****REPRESENTATIONS, WARRANTIES AND COVENANTS**

# ** **

## **13.1****                       ****Authority and Consents**

##  

### (a)                                  UCB and ImCloneeach represent and warrant to the other Party that as of the Effective Date:

###  

#### (i)                                     it has full right,power and authority to enter into this Agreement and perform its obligationsunder this Agreement and has taken all necessary corporate action on its partrequired to authorise the execution and delivery of this Agreement and theperformance of its obligations under this Agreement;

####  

#### (ii)                                  to its Knowledge,this Agreement constitutes a legal, valid and binding obligation of such Partythat is enforceable against it in accordance with its terms subject to alllimitations of bankruptcy, liquidation, principles of equity (includingmoratorium and enforcements of creditors’ rights generally), general principlesof equity (including those relating to specific performance, injunctions andother remedies) and public policy constraints (including those pertaining tolimitations or exclusion of liability, competition law, penalties andjurisdictional issues including conflicts of law);

####  

#### (iii)                               the execution,delivery and performance of this Agreement by such Party does not conflict withany agreement, instrument or understanding to which it is a party or by whichit is bound, nor to its Knowledge violate any law, rule or regulation of anycourt, governmental body or administrative or other agency having jurisdictionover it;

 

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#### (iv)                              such Party has notgranted any rights to any Third Party that would conflict with the rightsgranted to the other Party under this Agreement;

####  

#### (v)                                 such Party has theright to grant the licences, sublicences and other rights granted by itpursuant to this Agreement; and

####  

#### (vi)                              all employees andofficers (other than administrative and non-technical personnel) of it and its Affiliates involved in the Development,Commercialisation or Manufacture of Antibody Products for Agreed Indications orIndependent Indications have executed agreements requiring assignment to theParty or its Affiliates of all inventions made during the course of and as aresult of their association with such Party or its Affiliates and obligatingthe individual to maintain as confidential the confidential information of suchParty and its Affiliates.

####  

### (b)                                 UCB and ImCloneeach covenant and agree to the other Party that during the Term, neither it norits Affiliates will grant any rights to any Third Party that would conflictwith the rights granted to the other Party under this Agreement.

###  

### (c)                                  UCB and ImCloneeach represent and warrant to the other Party that neither it, nor any of itsAffiliates, has been debarred and is not subject to debarment and that it andthey have not used, and covenant that it will not, and will procure that itsAffiliates will not, use, in any capacity, in connection with the services tobe performed under the this Agreement, any person who has been debarredpursuant to section 306 of the FFDCA, 21 U.S.C. § 335a, or who is the subjectof a conviction described in such section (or under any analogous provisions ofApplicable Law outside the United States).

###  

## **13.2****                       ****Additional Representations and Warranties of ImClone**

##  

ImClone further represents and warrants to UCBthat as of the Effective Date:

 

### (a)                                  [***] [ConfidentialTreatment Required];

###  

### (b)                                 the Patent Rightsset forth in Part 4 of Schedule 1 constitute all of the ImClone Patent Rightsthat exist as of the Effective Date;

###  

### (c)                                  ImClone hasdisclosed to UCB the patents, patent applications and the officialcorrespondence from the corresponding file histories of the ImClone Core PatentRights;

###  

### (d)                                 ImClone has notreceived a written notice that ImClone or any of its Affiliates is in materialbreach or material default of any of the agreements listed in Part 2 ofSchedule 1, and true, complete and correct copies (with only such redactions asare necessary to protect confidential and financial information) of all suchagreements have been provided to UCB prior to the Effective Date;

###  

### (e)                                  ImClone has notreceived any written notice from a Third Party alleging that the Development,Commercialisation and Manufacturing activities contemplated by this Agreementwith respect to Antibody Products will

 

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infringe any Patent Rights or otherintellectual property or proprietary right of such Third Party, except forthose Patent Rights that are the subject of In-Licences and are included in theImClone Patent Rights; and

###  

### (f)                                    ImClone has madeavailable to UCB all information of which it has Knowledge relating to ThirdParty Patents which may be [***] [Confidential Treatment Required] adverse tothe Development, Commercialisation and Manufacturing activities contemplated bythis Agreement with respect to Antibody Products and which would have affectedUCB’s decision to enter into this Agreement.

###  

## **13.3****                       ****Additional Representations, Warranties and Covenants of UCB**

##  

UCB further represents and warrants to ImClonethat as of the Effective Date:

 

### (a)                                  [***] [ConfidentialTreatment Required]

###  

### (b)                                 the Patent Rightsset forth in Part 3 of Schedule 1 constitute all of the UCB Patent Rights thatexist as of the Effective Date;

###  

### (c)                                  UCB has disclosedto ImClone the patents, patent applications and the official correspondencefrom the corresponding file histories of the UCB Core Patent Rights;

###  

### (d)                                 UCB has notreceived a written notice that UCB or any of its Affiliates is in materialbreach or material default of the agreements listed in Part 1 of Schedule 1,and true, complete and correct copies (with only such redactions as are necessaryto protect confidential and financial information) of all such agreements havebeen provided to ImClone prior to the Effective Date;

###  

### (e)                                  UCB has notreceived any written notice from a Third Party alleging that the Development,Commercialisation and Manufacturing activities contemplated by this Agreementwith respect to Antibody Products will infringe any Patent Rights or otherintellectual property or proprietary right of such Third Party, except forthose Patent Rights that are the subject of In-Licences and are included in theUCB Patent Rights;

###  

### (f)                                    UCB has madeavailable to ImClone all information of which it has Knowledge relating toThird Party Patents which may be materially adverse to the Development,Commercialisation and Manufacturing activities contemplated by this Agreementwith respect to Antibody Products and which would have affected ImClone’sdecision to enter into this Agreement;

###  

### (g)                                 UCB has madeavailable to ImClone all INDs and other filings and all material correspondencewith the Regulatory Authorities relating to Antibody Products in UCB’spossession as of the Effective Date; and

###  

### (h)                                 UCB has disclosedto ImClone all [***] [Confidential Treatment Required] adverse information ofwhich it has Knowledge with respect to the safety and efficacy of the AntibodyProducts or otherwise [***] [Confidential Treatment Required] adverse to theDevelopment, Commercialisation and Manufacturing activities contemplated bythis Agreement with respect to Antibody Products

 

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and, in each case, which would have affectedImClone’s decision to enter into this Agreement.

###  

## **13.4****                       ****Disclaimer of Representation and Warranty**

##  

### (a)                                  Nothing in thisAgreement shall be construed as a warranty or representation by either Party:

###  

#### (i)                                     that theDevelopment, Commercialisation, Manufacture, making, having made, using,selling, having sold, offering to sell or reselling, importing, exporting,distributing or otherwise transferring physical possession of or otherwisetransferring title in or to any Antibody Product under, or in connection with,this Agreement is or will be free from infringement of, or that the activitiesconducted pursuant to this Agreement will not infringe, Patent Rights,copyrights, Trademarks, industrial design or other intellectual property rightsof any Third Party; or

####  

#### (ii)                                  that any AntibodyProduct Developed, Manufactured, Commercialised, made, made on its behalf,used, sold, sold on its behalf, offered to be sold or resold, imported,exported, distributed or with respect to which physical possession wasotherwise transferred or with respect to which title in or to was otherwisetransferred under this Agreement is or will be effective, valuable, safe,non-toxic or patentable.

####  

Each Party acknowledges and agrees that theactivities conducted pursuant to this Agreement and the Antibody Products areexperimental as of the Effective Date. EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, EACH PARTY EXPRESSLYDISCLAIMS, WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED,INCLUDING ANY WARRANTY OF EFFICACY, SAFETY, MERCHANTABILITY, SATISFACTORYQUALITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE WITH RESPECT TO ANY MATTERARISING IN CONNECTION WITH THIS AGREEMENT, INCLUDING ANY ACTIVITIES CONDUCTED HEREUNDER,OR ANY ANTIBODY PRODUCTS.

 

### (b)                                 Notwithstandinganything to the contrary in this Agreement, there shall be no limit orexclusion of any Party’s liability for fraud or for death or personal injurycaused by that Party’s own negligence or wilful misconduct.

###  

# **14.****                              ****INDEMNIFICATION AND INSURANCE**

# ** **

## **14.1****                       ****Indemnification**

##  

### (a)                                  Subject to Article14.1(b) and Article 14.1(c), each Party agrees to save, defend and hold theother Party, its Affiliates and their respective directors, officers, agentsand employees (collectively, the **Indemnitees**)harmless from and against any and all losses, damages, liabilities,settlements, penalties, fines, costs and expenses (including, [***][Confidential Treatment Required] attorneys’ fees and expenses) payable to aThird Party (collectively, **Losses**)arising out of any Third Party claims, suits, actions or demands (collectively,

 

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**Third PartyClaims**) resulting directly or indirectly from theDevelopment, Manufacturing, Commercialisation, use, handling, storage, sale orother disposition of Antibody Products by the indemnifying Party, itsAffiliates, or any of their respective Distributors, sublicensees or otheragents (other than the Indemnitees), but only to the extent such Losses resultfrom:

###  

#### (i)                                     [***] [ConfidentialTreatment Required] of the indemnifying Party, any of its Affiliates, or any oftheir respective Distributors, sublicensees or other agents (other than theIndemnitees);

####  

#### (ii)                                  any claim ofintellectual property infringement arising from the indemnifying Party’s use ofthe other Party’s Corporate Marks in a manner not permitted by this Agreement;

####  

#### (iii)                               any breach ofApplicable Law by the indemnifying Party, any of its Affiliates or any of theirrespective Distributors, sublicensees or other agents (other than theIndemnitees) in performing any activities in connection with this Agreement;

####  

#### (iv)                              any breach by theindemnifying Party or any of its Affiliates of this Agreement any ManufacturingAgreement, any agreement listed in Schedule 4 or any In-Licence entered intoprior to the Effective Date; or

####  

#### (v)                                 the Development orCommercialisation of an Antibody Product for Independent Indications by theindemnifying Party, any of its Affiliates or any of their respective Distributors,sublicensees or other agents (other than the Indemnitees) to the extent theindemnifying Party is the Continuing Party with respect thereto and only withrespect to Third Party Claims made prior to the date the Non-Continuing PartyConverts such Independent Indication to a Converted Agreed Indication pursuantto Article 8.9,

####  

in each case, save to the extent that suchLosses result from [***] [Confidential Treatment Required] of any of theIndemnitees or breach by any of the Indemnitees of this Agreement, anyManufacturing Agreement, any of the existing supply agreements listed inSchedule 4 or any In-Licence.  [***]  [Confidential Treatment Required].

 

### (b)                                 Upon termination ofthis Agreement, where there is a Remaining Party, the Remaining Party agrees tosave, defend and hold the Non-Remaining Party, its Affiliates and theirrespective directors, officers, agents and employees (the **Non-Remaining Party Indemnitees**) harmlessfrom and against any and all Losses arising out of any Third Party Claims tothe extent that such Losses result directly or indirectly from:

###  

#### (i)                                     the Development,Commercialisation, Manufacture, use, handling, storage, sale, offer to sell,resale, importation, exportation, distribution or other disposition or transferof physical possession of any Antibody Product by the Remaining Party, itsAffiliates, or any of their respective Distributors, sublicensees or otheragents (other than the

 

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Non-Remaining Party Indemnitees) (collectively,**Representatives**) after theeffective date of termination of this Agreement except to the extent that such Losses result directlyor indirectly from the Manufacture or supply of Antibody Product by or on behalfof the Non-Remaining Party or its Affiliates that does not meet the AntibodyProduct Standards or was not Manufactured in accordance with Applicable Law;

####  

#### (ii)                                  the use of theNon-Remaining Party’s Corporate Marks after the effective date of termination,save as permitted by Article 12.8(c); or

####  

#### (iii)                               any act or omissionof the Remaining Party after the effective date of termination that results inthe Non-Remaining Party being in breach of any In-Licence, any Third Partymanufacturing agreement or any other Third Party agreement with respect towhich the Non-Remaining Party, in accordance with Article 12.8(a)(iv), (viii)or (ix) (as applicable), remains a party after the effective date oftermination,

####  

in each case, save to the extent such Lossesresult from [***]   [Confidential Treatment Required]. of anyNon-Remaining Party Indemnitee or any breach by the Non-Remaining Party or its Affiliates of thisAgreement or any agreement referred to in paragraph (iii) above (save for anysuch breach resulting from any act or omission of the Remaining Party afterthe effective date of termination).

 

### (c)                                  The indemnity under Article 14.1(a) shall not apply toLosses arising out of Third Party Claims resulting directly or indirectly fromManufacturing activities conducted by any Third Party supplier pursuant to aManufacturing Agreement to which both UCB and ImClone are parties.  The indemnity under Article 14.1(a) shallapply to Losses arising out of Third Party Claims resulting directly orindirectly from Manufacturing activities conducted by any Third Party supplierpursuant to a Manufacturing Agreement or an existing supply agreement listed inSchedule 4, to which only the indemnifying Party is a party, *provided* that:

###  

#### (i)                                     [***]   [Confidential Treatment Required]; and

####  

#### (ii)                                  [***]   [Confidential Treatment Required].

####  

### (d)                                 In the event thateither Party receives notice of a Third Party Claim with respect to an AntibodyProduct in the Territory, such Party shall inform the other Party as soon asreasonably practicable.  The Partiesshall confer on how to respond to the Third Party Claim and how to handle theThird Party Claim in an efficient manner.

###  

### (e)                                  In the event that aParty is seeking indemnification under this Article 14 it shall inform theindemnifying Party of a Third Party Claim as soon as reasonably practicableafter it receives notice of the Third Party Claim, shall permit theindemnifying Party (at the indemnifying Party’s option) to assume direction andcontrol of the defence of the Third Party Claim (including the right to settlethe claim solely for monetary consideration), shall co-operate as

 

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requested ([***]   [Confidential TreatmentRequired]) in the defence of the Third Party Claim, and shall not settle orcompromise the Third Party Claim without the express written consent of theindemnifying Party, [***]   [Confidential Treatment Required].

###  

## **14.2****                       ****Insurance**

##  

Beginning on the first date after the EffectiveDate that an [***]   [Confidential Treatment Required], UCB and ImCloneshall each use its [***]   [Confidential Treatment Required] to procureand maintain, [***]   [Confidential Treatment Required], the followinginsurance coverages:

 

### (a)                                  Public and ProductLiability, including coverage for products and completed operations (includingcoverage for advertising and personal injury), which is maintained for a periodof at least [***]   [Confidential Treatment Required].  The policy shall have a limit of no less than[***]   [Confidential Treatment Required].

###  

### (b)                                 Foreign LocalCoverage:  Where required by ApplicableLaw for the activities of either Party with respect to Antibody Products, suchParty shall effect foreign local coverages in an amount [***]  [Confidential Treatment Required];

###  

*provided* that, tothe extent that such insurance covers [***]   [Confidential TreatmentRequired].  The Parties will discuss theavailability of insurance coverage for each [***]   [ConfidentialTreatment Required].  Unless otherwiseagreed each Party shall obtain insurance for [***]   [ConfidentialTreatment Required].

 

All policies under (a) and (b) above shall bewritten by insurance companies with an [***]   [Confidential TreatmentRequired].  Each Party shall provide tothe other Party a copy of the corresponding certificate of insurance orbroker’s certificate evidencing such coverages and shall notify the other Partyif at any time any insurance coverage effected pursuant to this Article 14.2 isvoided or cancelled.

 

# **15.****                              ****DISPUTE RESOLUTION**

# ** **

## **15.1****                       ****Committees and Chief Executive Officer Review**

##  

The Parties recognise that disputes as tocertain matters may from time to time arise during the Term which relate toeither Party’s rights and/or obligations under this Agreement and which are notresolved by the Collaboration Committee. It is the objective of the Parties to establish procedures to facilitatethe resolution of disputes arising from, concerning or in any way relating tothis Agreement or the collaboration (whether or not such dispute gives rise toa right to terminate this Agreement) (each a **Dispute**)in an expedient manner by mutual co-operation and without resort tolitigation.  Unless otherwise expresslyprovided in this Agreement (including pursuant to Article 4.7(c)), all Disputesshall be decided pursuant to this Article 15.

 

### (a)                                  Unless otherwiseexpressly provided in this Agreement, all Disputes (including any disputewithin the JDT, JCT, JMT or JPC) shall first be

 

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referred to the Collaboration Committee forresolution in accordance with the provisions of Article 3.3(a).

###  

### (b)                                 If theCollaboration Committee is unable to resolve any Dispute within [***]  [Confidential Treatment Required] after such matter was first referred to orconsidered by the Collaboration Committee, whichever is earlier, or in suchlonger period of time as the Parties may agree:

###  

#### (i)                                     if the Disputefalls within Article 15.2, it may be resolved [***]   [Confidential Treatment Required] by theParty [***]   [Confidential TreatmentRequired] in accordance with that Article;

####  

#### (ii)                                  subject to Article15.1(b)(iii), if neither Party is entitled to resolve such Dispute [***]   [Confidential Treatment Required] inaccordance with Article 15.2, then such matter shall, at the written request ofeither Party, be referred to the Chief Executive Officers of each of theParties as soon as practicable but in any event no later than [***]   [Confidential Treatment Required] after suchrequest.  Each Chief Executive Officershall have the right to engage the services of any number of independentexperts in the field in question (such independent expert(s) to be engagedunder obligations of confidentiality and non-use equivalent to those set forthin Article 11 and at the [***]  [Confidential Treatment Required]) to assist the Chief Executive Officerin making a determination on the unresolved Dispute, and each Chief ExecutiveOfficer shall consider in good faith the analyses and opinions of any suchindependent experts engaged by either of them in making a determination.  If the Chief Executive Officers are unable toresolve the Dispute within [***]  [Confidential Treatment Required] after such referral, or such longer periodas the Chief Executive Officers may agree, the matter shall be resolved pursuantto Article 15.3, except as otherwise provided in Article 15.5; or

####  

#### (iii)                               if the Disputerelates to the characterization of any Information, Materials or Patent Rightsas ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and JointPatent Rights it shall be resolved by an expert in accordance with Article15.6.

####  

## **15.2****                       ****[***]   [ConfidentialTreatment Required]**

##  

### (a)                                  Subject to Articles15.2(b) and 15.2(c), any Dispute listed in this Article 15.2(a) may, if it hasnot been resolved by the Collaboration Committee in accordance with Article15.1(b), be resolved [***]  [Confidential Treatment Required]:

###  

#### (i)                                     a Dispute regardingthe proposed implementation of the Development Plan for an Antibody Product foran Agreed Indication, *provided*that the proposed implementation of the Development Plan is within the scope ofthat Development Plan and the Development Budget and is not a Dispute regardingManufacturing.  [***]   [Confidential Treatment Required];

 

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#### (ii)                                  a Dispute regardingthe Development of an Antibody Product for an Independent Indication.  [***]  [Confidential Treatment Required];

####  

#### (iii)                               a Dispute regardingCommercialisation other than:  (A) aDispute regarding Manufacturing or (B) a Dispute as to whether either Party hasused [***]   [Confidential TreatmentRequired] to Commercialise an Antibody Product in the countries for which it isTerritorial Lead.  [***]   [Confidential Treatment Required];

####  

#### (iv)                              a Dispute regardingproposed implementation of the Manufacturing Plan, *provided* that the proposed implementation of theManufacturing Plan is within the scope of that Manufacturing Plan, theDevelopment Budget and the Commercialisation Budget, and *provided**further*that such Dispute does not relate to: [***]   [Confidential TreatmentRequired];

####  

#### (v)                                 a Dispute regardingthe depiction of a Party’s own Corporate Mark on any Promotional Materials,packaging or Product Labelling for Antibody Products.  [***]  [Confidential Treatment Required];

####  

#### (vi)                              a Dispute regardingthe formulation of the Transition Plan, *provided*that the aspects of the proposed Transition Plan in issue are consistent withthe Development Plan, the Manufacturing Plan and the CommercialisationPlan.  [***]   [Confidential Treatment Required]; and

####  

#### (vii)                           a Dispute regardingthe formulation of the transfer plan in accordance with Article 8.6, *provided* that the aspects of the proposedtransition plan in issue are consistent with the Development Plan, theManufacturing Plan and the Commercialisation Plan.  [***]  [Confidential Treatment Required].

####  

### (b)                                 NotwithstandingArticle 15.2(a), the Parties agree that:

###  

#### (i)                                     [***]  [Confidential Treatment Required];

####  

#### (ii)                                  [***]  [Confidential Treatment Required];

####  

#### (iii)                               [***]  [Confidential Treatment Required];

####  

#### (iv)                              [***]  [Confidential Treatment Required];

####  

#### (v)                                 [***]  [Confidential Treatment Required]; and

####  

#### (vi)                              [***]  [Confidential Treatment Required].

####  

### (c)                                  The Parties shallmake all decisions with respect to Disputes subject [***]   [ConfidentialTreatment Required].

 

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## **15.3****                       ****Mediation**

##  

If pursuant to Article 15.1(b)(ii), the ChiefExecutive Officers are not able to resolve a dispute as described thereinwithin [***]   [Confidential TreatmentRequired], or such longer period as the Chief Executive Officers may agree (the**CEO Period**), then the Partiesagree to try in good faith to resolve the dispute by non-binding mediation fora period not to exceed [***]  [Confidential Treatment Required], or such longer period as the Partiesmay agree, from the date of a written request by either Party to do so, *provided* such request is made within[***]   [Confidential Treatment Required]after the end of the CEO Period.  Themediation shall be conducted by [***]   [Confidential Treatment Required]to be appointed expeditiously by [***]   [Confidential Treatment Required]which mediation shall be administered in accordance with the [***]   [Confidential Treatment Required] mediationrules, except to the extent such rules conflict with any provision of thisArticle 15.3 in which event such rules shall be waived and the applicableprovision of this Article 15.3 shall apply. Unless otherwise mutually agreed upon by the Parties, the mediationproceedings shall be conducted in [***]  [Confidential Treatment Required] and conducted in English.  The Parties agree that they shall [***]   [Confidential Treatment Required].  [***]  [Confidential Treatment Required]. If the dispute remains unresolved after such sixty ([***]   [Confidential Treatment Required], theneither Party shall have the right to resolve such dispute pursuant to Article15.4.

 

## **15.4****                       ****Arbitration**

##  

If the Parties are unable to resolve a disputepursuant to Article 15.3, then, except as provided in Articles 15.5 and 15.6,they shall, at the written request of either Party, enter into arbitrationunder the terms of this Article 15.4. Within [***]   [Confidential TreatmentRequired] of delivery of notice from one Party to the other initiatingarbitration under this Article 15.4, each Party shall select one disinterested,conflict-free, neutral with relevant expertise in the field of drug developmentif the dispute relates to Development or in the field of drug commercialisationif the dispute relates to Commercialisation or such other field(s) as may berelevant to the dispute, to serve on an arbitration panel to resolve theissue.  The neutral selected by a Partyshall not be a past or present employee of or consultant to such Party or ofany Affiliate of such Party.  The membersof the panel selected by the Parties shall, within [***]   [Confidential Treatment Required] of theirselection, select a third disinterested, conflict-free neutral to chair thepanel who shall be a lawyer of not less than [***]   [Confidential Treatment Required] standingwith experience in the pharmaceutical industry and who shall not be a past orpresent employee of or consultant to either Party or any Affiliate of suchParty.  If the members of the panelselected by the Parties cannot, within [***]  [Confidential Treatment Required] of their selection, agree on a thirdmember, the Parties shall request that the [***]   [Confidential Treatment Required] select thethird disinterested, conflict-free member who shall meet the requirements forthe third member specified in this Article 15.4.  Consistent with the objective of concludingthe proceeding expeditiously, the panel may require and facilitate suchdiscovery as it shall determine is appropriate in the circumstances, takinginto account the needs of the Parties and the desirability of making discoveryexpeditious and cost-effective.  Thepanel may issue orders to protect the confidentiality of ConfidentialInformation disclosed in discovery.  EachParty shall then have [***]  [Confidential Treatment Required] to submit to the panel a written

 

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statement of such Party’s position on theissue, which statements shall be provided to the other Partysimultaneously.  Each Party shall, within[***]   [Confidential Treatment Required]of receipt of the other Party’s written statement, submit to the panel awritten reply, which statements shall be provided to the other Party simultaneously.  The panel shall, within [***]   [Confidential Treatment Required] afterreceipt of both Parties’ written replies, hold a joint meeting on the issue atwhich each Party will have an opportunity to make a presentation and to respondto the other Party’s presentation. Within [***]   [ConfidentialTreatment Required] of the conclusion of the meeting, the panel shall renderits decision in writing.  The panel mayextend any of the foregoing time limitations to the extent necessary to conductsuch arbitration in a fair and equitable manner with due regard for theobjective of concluding the proceeding expeditiously.  The prevailing Party may enter such decisionin any court having competent jurisdiction. The decision of the panel shall be binding on both Parties and shall notbe subject to appeal.  [***]  [Confidential Treatment Required].  Thecosts of the third panel member shall [***]   [Confidential TreatmentRequired].  Any arbitration shall be heldin [***]   [Confidential TreatmentRequired], conducted in English, and conducted under the rules of the[***]   [Confidential Treatment Rrequired],except to the extent such rules conflict with any provision of this Article15.4 in which event the applicable provision of this Article 15.4 shall apply.

 

## **15.5****                       ****Matters to proceed to Court**

##  

### (a)                                  Notwithstanding theforegoing: (i) any dispute relating to the determination of validity,enforceability or infringement of a Party’s Patent Rights or Trademarks shallnot be submitted to arbitration but shall instead be submitted exclusively tothe courts in the jurisdiction of the relevant Patents or Trademarks, and theParties consent to the jurisdiction of such courts and (ii) nothing in thisAgreement shall prohibit a Party from seeking interim relief in any court ofcompetent jurisdiction.

###  

### (b)                                 With respect to anydispute relating to the determination of validity, enforceability orinfringement of a Party’s Patent Rights or Trademarks, the Parties herebyirrevocably and unconditionally waive any objection to the laying of venue ofany action, suit or proceeding (other than appeals therefrom) with respect tosuch disputes in the courts in the jurisdiction of the relevant Patents orTrademarks, and hereby further irrevocably and unconditionally waive and agreenot to plead or claim in any such court that any such action, suit orproceeding brought in any such court has been brought in an inconvenient forum.

###  

### (c)                                  Each Party furtheragrees that service of any process, summons, notice or document by registeredmail to its address set forth in Article 17.2, or any other lawful means, shallbe effective service of process for any action, suit or proceeding broughtagainst it in any such court with respect to any dispute relating to thedetermination of validity, enforceability or infringement of a Party’s Patent Rightsor Trademarks.

 

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## **15.6****                       ****Expert Determination of Disputes regarding Characterisationof Intellectual Property**

##  

If the Parties are unable to resolve a Disputerelating to the characterisation of any Information, Materials or Patent Rightsas ImClone Core Patent Rights, UCB Core Patent Rights, Joint Know-How and JointPatent Rights, the Parties shall upon written request by either Party to theother Party, promptly negotiate in good faith to appoint a mutually acceptabledisinterested, conflict-free individual not affiliated with either Party, withrelevant experience necessary to resolve such dispute (an **Expert**). If the Parties are not able to agree within [***]   [Confidential Treatment Required] after thereceipt by a Party of the written request in the immediately precedingsentence, the [***]   [CONFIDENTIALTREATMENT REQUIRED], or such other similar entity as the Parties may agree,shall be responsible for selecting an Expert within [***]   [Confidential Treatment Required] of beingapproached by a Party.  The fees andcosts of the Expert and the [***]  [CONFIDENTIAL TREATMENT REQUIRED] (or such other entity) shall be [***]   [Confidential Treatment Required].  Within [***]  [Confidential Treatment Required] after the designation of the Expert,the Parties shall each simultaneously submit to the Expert and one another awritten statement of their respective positions on such disagreement.  Each Party shall have [***]   [Confidential Treatment Required] fromreceipt of the other Party’s submission to submit a written response thereto,which shall include any scientific and technical information in supportthereof.  The Expert shall have the rightto meet with the Parties, either alone or together, as necessary to make adetermination.  No later than [***]   [Confidential Treatment Required] after thedesignation of the Expert, the Expert shall make a determination by selecting theresolution [***]   [ConfidentialTreatment Required] and shall provide the Parties with a written statementsetting forth the basis of the determination in connection therewith.  The decision of the Expert shall be final andconclusive, absent manifest error.

 

# **16.****                              ****IMCLONE OPTION; COMPETING PRODUCTS**

# ** **

## **16.1****                       **[***]   [Confidential Treatment Required].

##  

## **16.2****                       **TheParties acknowledge that ImClone (or one of its Affiliates) is currentlyconducting a development programme in respect of one or more Antibodies,including 1121B, any of which is or may be a Competing Product or otherwisecompetitive with an Antibody Product.  Bythe date (the **Opt-Out Date**) whichis the earlier of (a) [***]  [Confidential Treatment Required] after the date of acceptance by theFDA for filing of the first Drug Approval Application in respect of anyAntibody Product in the United States and (b) the fifth anniversary of theEffective Date, ImClone shall either:

##  

### (a)                                  terminate thisAgreement pursuant to Article 12.2, in which event, for the avoidance of doubt,ImClone and its Affiliates shall continue to have the right to develop, and,effective upon the date of such notice, the right to make, have made, use,sell, have sold, offer to sell, resell, import, export, distribute, otherwisetransfer physical possession of or otherwise transfer title in or to orotherwise commercialise Competing Products, including 1121B, regardless of anyapplicable Transition Period and notwithstanding anything to the contrary inthis Agreement; or

 

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### (b)                                 cease (and procurethat all of its Affiliates cease) all Competing Activities, including inrelation to 1121B, and undertake to UCB that, subject to Article 16.4, it shallnot and shall procure that its Affiliates shall not thereafter engage in anyCompeting Activities.  If on or after theOpt-Out Date, ImClone or any of its Affiliates is engaged in any CompetingActivities, including in respect of 1121B, UCB may, subject to Article 16.4,terminate this Agreement pursuant to Article 12.3.

###  

## **16.3****                       **If,prior to the Opt-Out Date, ImClone provides UCB with a written (i) confirmationthat ImClone and its Affiliates have ceased all Competing Activities; and (ii)undertaking that it will not (and will procure that all of its Affiliates willnot) thereafter engage in any Competing Activities during the Term, then (andin any event on and after the Opt-Out Date), (x) to the extent that at thattime UCB or its Affiliates are engaged in any Competing Activity, within[***]   [Confidential Treatment Required]of receipt of such notice (or such date), UCB and its Affiliates shall ceaseall Competing Activities, and (y) UCB shall, and does hereby, undertake toImClone that it will not (and will procure that all of its Affiliates willnot), subject to Article 16.4, thereafter engage in any Competing Activitiesduring the Term.  If on or after the datethat is [***]   [Confidential TreatmentRequired] after receipt of such notice, UCB or any of its Affiliates is engagedin Competing Activities, ImClone may, subject to Article 16.4, terminate thisAgreement pursuant to Article 12.3.

##  

## **16.4****                       **Ifeither Party or any of its Affiliates (to the extent that such Affiliateremains an Affiliate of a Party (or its successor, if applicable) immediatelyafter the effective date of such transaction) merges or consolidates with, isotherwise acquired by, or acquires, a Third Party or otherwise undergoes asimilar transaction and if such Third Party (or any of its Affiliates) is as ofthe effective date of such transaction engaged, directly or indirectly, in aCompeting Activity this Article 16.4 (and not Articles 16.2(b) and 16.3) shallapply.  The merging or consolidatingParty (or its successor), or the acquired Party or its acquirer, as the casemay be (including their Affiliates, as applicable), (collectively the **Merging Party**) shall, within [***]   [Confidential Treatment Required] after suchdate, notify the other Party whether it intends to: (x) cease permanently, orcause its acquirer or acquiree to cease permanently, all Competing Activities;(y) divest, or cause its acquirer or acquiree to divest, whether by licence orotherwise, the Competing Product; or (z) terminate this Agreement pursuant toArticle 12.2.

##  

### (a)                                  If the MergingParty either notifies such other Party in writing within such [***]   [Confidential Treatment Required] periodthat it intends to cease permanently, or cause its acquirer or acquiree tocease permanently, all conduct of the Competing Activities, the Merging Partyshall (i) cease all Competing Activities as expeditiously as possible with dueregard for patient safety and the rights of any subjects that are participantsin any clinical studies or post-approval studies relating to the CompetingProduct and Applicable Law; and (ii) keep the other Party reasonably informedof its efforts and progress in effecting such cessation of activities until itis completed, and shall provide a written summary of such efforts each CalendarQuarter until completed.

###  

### (b)                                 If the MergingParty notifies such other Party in writing within such [***]   [Confidential Treatment Required] periodthat it intends to divest such

 

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Competing Product, the Merging Party shall useall [***]   [Confidential TreatmentRequired] to effect such divestiture as quickly as possible and shall keep theother Party reasonably informed of its efforts and progress in effecting suchdivestiture until it is completed, and shall provide a written summary of suchefforts each Calendar Quarter until completed. If the Merging Party effects such divestiture by way of one or moresublicences, the Merging Party shall be entitled [***]   [Confidential Treatment Required].  In addition, the Merging Party shall have theright to take back rights to such Competing Product if the licensee materiallybreaches its obligations under its licence agreement with the Merging Party (inwhich event such Competing Product shall again become subject to the terms ofthis Article 16.4).

###  

## **16.5****                       **NotwithstandingArticles 16.2, 16.3, and 16.4, the Parties shall be entitled to Develop[***]   [Confidential Treatment Required]any Competing Product up to and including [***]   [Confidential Treatment Required]the PartyDeveloping such Competing Product (the **DevelopingParty**) shall provide to the other Party (the **Non-Developing Party**) (via the JDT) acomplete Data Package for such Competing Product (to the extent suchinformation is available to [***]  [Confidential Treatment Required] by the Developing Party).

##  

### (a)                                  The Non-DevelopingParty shall have the right on written notice to the Developing Party (a **CP Conversion Notice**) within [***]   [Confidential Treatment Required] of receiptof such Data Package to convert such Competing Product into an Antibody Product(such conversion from a Competing Product to an Antibody Product, a **CP Conversion**).  In connection with the exercise of any suchCP Conversion, the Non-Developing Party shall have the right, on written noticeto the Developing Party, to request additional information.  Within [***]  [Confidential Treatment Required] of receipt of such request, theDeveloping Party shall provide the Non-Developing Party with a statement of the[***]   [Confidential Treatment Required]occurring immediately before the date of such request for additional informationand any updates to the complete Data Package that are available[***]   [Confidential Treatment Required] by theDeveloping Party.  Within [***]   [Confidential Treatment Required] of receiptof such information, the Non-Continuing Party shall have the right to provide aCP Conversion Notice to the Developing Party to convert the applicableCompeting Product into an Antibody Product, provided that if the Non-DevelopingParty fails to serve such CP Conversion Notice within such [***]   [Confidential Treatment Required]period, theNon-Developing Party’s CP Conversion right shall be deemed to have lapsed inrespect of such Competing Product and the Non-Developing Party shall have nofurther right to convert such Competing Product into an Antibody Product.

###  

### (b)                                 If theNon-Developing Party timely delivers a CP Conversion Notice, the DevelopingParty shall within [***]   [ConfidentialTreatment Required] of receipt of the CP Conversion Notice provide theNon-Developing Party with an updated statement of all of [***]   [Confidential Treatment Required].  Within [***]  [Confidential Treatment Required] of receipt of such updated statement,the Non-Developing Party shall [***]  [Confidential Treatment Required]. If [***]   [Confidential TreatmentRequired]

 

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### (c)                                  Upon [***]   [Confidential Treatment Required], suchCompeting Product shall be deemed to be converted into an Antibody Product foran Agreed Indication for all purposes under this Agreement, including withrespect to Developmental Costs and Operating Profits and Losses, which shall be[***]   [Confidential TreatmentRequired].  If such conversion does nottake place the provisions of Articles 16.2 and 16.3 shall apply and theDeveloping Party shall not engage in any Competing Activities in relation tosuch Competing Product, whether alone or with or through any Third Party.

###  

## **16.6****                       **Forthe avoidance of doubt, ImClone and its Affiliates are not licensed to develop,make, have made, use, sell, have sold, offer to sell, resell, import, export,distribute, exploit, transfer physical possession of or otherwise transfertitle in or to and shall not develop, make, have made, use, sell, have sold,offer to sell, resell, import, export, distribute, exploit, transfer physicalpossession of or otherwise transfer title in or to any UCB Patent Rights or UCBKnow-How in relation to any Antibody Product other than an Antibody ProductDeveloped, Manufactured or Commercialised pursuant to this Agreement.

##  

## **16.7****                       **Forthe avoidance of doubt, UCB and its Affiliates are not licensed to develop,make, have made, use, sell, have sold, offer to sell, resell, import, export,distribute, exploit, transfer physical possession of or otherwise transfertitle in or to and shall not develop, make, have made, use, sell, have sold,offer to sell, resell, import, export, distribute, exploit, transfer physicalpossession of or otherwise transfer title in or to any ImClone Patent Rights orImClone Know-How in relation to any Antibody Product other than an AntibodyProduct Developed, Manufactured or Commercialised pursuant to this Agreement.

##  

# **17.****                              ****MISCELLANEOUS**

# ** **

## **17.1****                       ****Amendments**

##  

This Agreement may not be modified orsupplemented by any purchase order, change order, acknowledgement, orderacceptance, standard terms of sale, invoice or the like.  Any amendment or modification to thisAgreement shall be made in a writing expressly stated for such purpose andsigned by an authorised officer of each Party; except that the Development Planand Commercialisation Plan may be amended or updated as expressly permitted bythis Agreement.

 

## **17.2****                       ****Notices**

##  

All notices under this Agreement shall be inwriting and shall be deemed given if delivered personally or by facsimiletransmission (receipt verified), mailed by registered or certified mail (returnreceipt requested), postage prepaid, or sent by express courier service, to theParties at the following addresses (or at such other address for a Party asshall be specified by like notice; *provided*that notices of a change of address shall be effective only upon receipt).

 
| If to UCB, addressed to: |   | UCB, S.A.                   |
|--------------------------|--------|-----------------------------|
|                     |   | Allée de la Recherche, |
|                     |   | 60 1070 Brussels            |
|                     |   | Belgium                     |

 

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|                         |   | Attention:                   | General Counsel  |
|------------------------------|--------|------------------------------|------------------|
|                         |   | Telephone:                   | (32-2) 559.99.99 |
|                         |   | Fax:                         | (32-2) 559.99.00 |
|                         |   |                         |
| If to ImClone, addressed to: |   | ImClone Systems Incorporated |
|                         |   | 180 Varick Street            |
|                         |   | New York, NY 10014           |
|                         |   | United States of America     |
|                         |   |                         |
|                         |   | Attention:                   | General Counsel  |
|                         |   | Telephone:                   | (212) 645-1405   |
|                         |   | Fax:                         | (212) 645-2770   |

## ** **

## **17.3****                       ****Force Majeure**

##  

Neither Party shall be held liable orresponsible to the other Party nor be deemed to have defaulted under orbreached this Agreement for failure or delay in fulfilling or performing anyterm of this Agreement to the extent such failure or delay is caused by orresults from Force Majeure, *provided*,*however*, that the Party soaffected shall use [***]   [ConfidentialTreatment Required] to avoid, remove or mitigate such causes of non-performanceand shall continue performance with reasonable dispatch wherever such causes areremoved.  Each Party shall provide theother Party with prompt written notice of any delay or failure to perform thatoccurs by reason of Force Majeure.  Suchexcuse shall be continued so long as the condition constituting Force Majeurecontinues.  The Parties shall mutuallyseek in good faith a resolution of the delay or failure to perform.

 

## **17.4****                       ****Use of Names, Logos or Symbols**

##  

Except as otherwise expressly provided in thisAgreement (including with respect to ImClone Company Marks and UCB CompanyMarks), neither Party shall use and no rights are granted to the Trademarks(including the names ImClone and UCB), domain names, physical likeness,employee names or owner symbols of the other Party for any purpose (includingprivate or public securities placements) without the prior written consent ofthe other Party[***]   [ConfidentialTreatment Required].

 

## **17.5****                       ****Governing Law**

##  

This Agreement, including any proceedings underArticle 15, shall be governed by and construed in accordance with the laws ofthe State of New York, excluding any conflicts or choice of law rule orprinciple that might otherwise refer construction or interpretation of thisAgreement to the substantive law of another jurisdiction, other than Section5-1401 of the New York General Obligations Law. The Parties agree to exclude the application to this Agreement of theUnited Nations Convention on Contracts for the International Sale of Goods.

 

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## **17.6****                       ****Performance by Affiliates**

##  

### (a)                                  Each of UCB andImClone acknowledges that obligations under this Agreement may be performed ona subcontracting basis by their respective Affiliates.  Each of UCB and ImClone remains responsiblefor the acts and omissions in the performance of this Agreement of its Affiliates.  To the extent the Parties delegateresponsibility to Affiliates, the Parties agree that such entities may not makedecisions inconsistent with this Agreement.

###  

### (b)                                 Each Party agreesthat any information or material provided to it or its Affiliates by the otherParty’s Affiliates or subcontractors shall be deemed to be Information orMaterials provided by the other Party.

###  

## **17.7****                       ****Assignment**

##  

A Party’s rights and obligations under thisAgreement may not be assigned or otherwise transferred by any Party without theconsent of the other Party, [***]   [Confidential Treatment Required]; *provided*, *however*,that either UCB or ImClone may, without such consent, assign its rights andobligations under this Agreement:

 

### (a)                                  to any Affiliate, *provided* that such interest shall beretransferred to the relevant Party if such entity ceases to be an Affiliate ofsuch Party, and *provided further*that the assigning Party shall remain responsible for the acts and omissions inthe performance of this Agreement of its Affiliate; or

###  

### (b)                                 in connection witha merger, consolidation or sale of substantially all of the business to whichthis Agreement relates to an unrelated Third Party of good financial standing.

###  

Any assignment or other transfer in violationof this Article 17.7 shall be void ab initio.

 

## **17.8****                       ****Subcontracting**

##  

The Parties acknowledge and agree that,notwithstanding anything to the contrary in this Agreement, elements of thework involved in Development, Manufacture and Commercialisation of AntibodyProduct may be subcontracted to a Third Party by the responsible Party and thatthe granting Party entering into such subcontract may, as part of suchsubcontract, grant to such Third Party a right to use ImClone Patent Rights,ImClone Know-How, ImClone Company Marks, UCB Patent Rights, UCB Know-How, UCBCompany Marks and Product Trademarks, as applicable, only to the extent andonly for so long as such use is necessary for such subcontractor to performsuch tasks; *provided, however*,that the responsible Party shall not be relieved of its obligation under thisAgreement and shall remain responsible and liable for the acts and omissions inthe performance of such work by its subcontractors.

 

## **17.9****                       ****No Strict Construction**

##  

This Agreement has in its entirety beenprepared jointly by the Parties and not by one Party and the Parties agree thatthis Agreement should be construed accordingly (whether in whole or in part)and no rule of strict construction shall be applied against either Party.

 

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## **17.10****                ****Interpretation and Schedules**

##  

### (a)                                  The captions orheadings of the Articles or other subdivisions of the Articles are insertedonly as a matter of convenience or for reference and shall have no effect onthe meaning of the provisions of this Agreement.

###  

### (b)                                 Unless otherwisespecified references in this Agreement:

###  

#### (i)                                     to any Article orSchedule means references to such Article or Schedule of this Agreement;

####  

#### (ii)                                  to any agreement,instrument or other document in this Agreement refer to such agreement,instrument or other document as originally executed or, if subsequently varied,replaced or supplemented from time to time, as so varied, replaced orsupplemented and in effect at the relevant time of the reference to it; and

####  

#### (iii)                               to any personincludes a body corporate and an unincorporated association of persons.

####  

### (c)                                  Any statute definedor referred to in this Agreement or in any agreement or instrument or otherdocument that is referred to in this Agreement means such statute as from timeto time amended, modified or supplemented, including by succession ofcomparable successor statutes and references to all attachments to it andinstruments incorporated into any of them. Subject to Article 17.7, references to an entity or person are also toits permitted successors and assigns.

###  

### (d)                                 All Schedulesannexed to this Agreement or referred to in this Agreement are incorporatedinto and made a part of this Agreement as if set out in full in thisAgreement.  Any capitalised terms used inany Schedule but not otherwise defined in such Schedule, shall have the meaningas defined in this Agreement.  Anycapitalised terms used in this Agreement but not otherwise defined in thisAgreement, shall have the meaning as defined in Schedule 2.

###  

### (e)                                  Whenever the words“include,” “includes” or “including” are used in this Agreement, they shall bedeemed to be followed by the words “without limitation”.  Except where the context requires otherwise,the word “or” has the inclusive meaning represented by the phrase “and/or.”

###  

### (f)                                    The provisions ofthis Article 17.10 shall apply unless the contrary intention appears.

###  

## **17.11****                ****Severability**

##  

If any provision of this Agreement is held tobe illegal, invalid or unenforceable under any present or future law, and ifthe rights or obligations of either Party under this Agreement will not bematerially and adversely affected thereby, (a) such provision shall be fullyseverable, (b) this Agreement shall be construed and enforced as if suchillegal, invalid or unenforceable provision had never comprised a part hereof,(c) the remaining provisions of this Agreement shall remain in full force andeffect and shall not be affected by the illegal, invalid or unenforceableprovision or by its severance

 

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herefrom, and (d) in lieu of such illegal,invalid or unenforceable provision, there shall be added automatically as apart of this Agreement a legal, valid and enforceable provision as similar interms to such illegal, invalid or unenforceable provision as may be possibleand [***]   [Confidential TreatmentRequired] acceptable to the Parties herein. To the fullest extent permitted by Applicable Law, each Party herebywaives any provision of law that would render any provision prohibited orunenforceable in any respect.

 

## **17.12****                ****No Consequential Damages**

##  

NEITHER PARTY WILL BE LIABLE FOR SPECIAL,INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR RELATING TO THISAGREEMENT OR THE EXERCISE OF ITS RIGHTS UNDER THIS AGREEMENT, OR FOR LOSTPROFITS, ANTICIPATED PROFITS, LOST GOODWILL, LOST REVENUE, LOST PRODUCTION,LOST CONTRACTS OR LOST OPPORTUNITY, ARISING FROM OR RELATING TO THIS AGREEMENT,WHETHER DENOMINATED IN OR ARISING IN CONTRACT, TORT OR OTHERWISE REGARDLESS OFANY NOTICE OF SUCH DAMAGES.  NOTHING INTHIS ARTICLE 17.12 IS INTENDED TO LIMIT OR RESTRICT ANY PAYMENT OBLIGATIONEXPLICITLY CONTAINED IN THIS AGREEMENT (INCLUDING THE INDEMNITIES SET OUT INARTICLE 14).

 

## **17.13****                ****Equitable Relief**

##  

Each Party acknowledges and agrees that therestrictions set forth in Article 11 and Article 17.4 are reasonable andnecessary to protect the legitimate interests of the other Party and that suchother Party would not have entered into this Agreement in the absence of suchrestrictions, and that any violation or threatened violation of any provisionof such Articles will result in irreparable injury to such other Party.  Each Party also acknowledges and agrees thatin the event of a violation or threatened violation of any provisions ofArticle 11 and Article 17.4 the other Party shall be entitled to preliminaryand permanent injunctive relief, without the necessity of proving irreparableinjury or actual damages and without the necessity of having to post a bond, aswell as to an equitable accounting of all earnings, profits and other benefitsarising from any such violation.  Therights provided in the immediately preceding sentence shall be cumulative andin addition to any other rights or remedies that may be available to such otherParty.  Nothing in this Article 17.13 isintended, or should be construed, to limit such other Party’s right topreliminary and permanent injunctive relief or any other remedy for breach ofany other provision of this Agreement.

 

## **17.14****                ****Change Of Control**

##  

A Party subject to a Change of Control (the **Acquired Party**) shall provide writtennotice to the other Party (the **Non-AcquiredParty**), where possible, at least [***]   [Confidential Treatment Required] prior tothe Change of Control or, where not possible, as soon as the impending Changeof Control can be disclosed to the Non-Acquired Party.  Within [***]  [Confidential Treatment Required] of the receipt of a written noticepursuant to this Article 17.14, the Chief Executive Officer of each Party shallmeet to discuss the impact of any proposed Change of Control upon thecollaboration and the commercial value of any Antibody Product for an Agreed

 

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Indication and to discuss the possible natureof the relationship with the combined entity.

 

## **17.15****                ****General Provisions**

##  

### (a)                                  Therepresentations, warranties, covenants and agreements contained in thisAgreement are for the sole benefit of the Parties and their successors andpermitted assigns, and a person who is not a Party to this Agreement may notenforce any of its terms.

###  

### (b)                                 A waiver (whetherexpress or implied) by one of the Parties of any of the provisions of thisAgreement or of any breach by or default of the other Party in performing anyof those provisions must be in writing executed by a responsible officer of theParty providing the waiver and expressly waiving such provisions or breach ordefault by reference to this Agreement, and any waiver shall not constitute acontinuing waiver, and that waiver shall not prevent the waiving Party fromsubsequently enforcing any of the provisions of this Agreement not waived orfrom acting on any subsequent breach by or default of the other Party under anyof the provisions of this Agreement.

###  

### (c)                                  Each Partyundertakes to execute all documents and perform all acts that may be [***]   [Confidential Treatment Required] to givefull effect to this Agreement.

###  

### (d)                                 Each Party shallpay its costs and expenses incurred by it in connection with negotiation andexecution of this Agreement.

###  

### (e)                                  It is expresslyagreed that for all purposes:

###  

#### (i)                                     this Agreement orany portion of this Agreement shall not be considered to be a partnershipagreement; and

####  

#### (ii)                                  the relationshipbetween the two Parties shall not constitute an employee-employer, partnership,joint venture, agency or similar business relationship between theParties.  Neither UCB nor ImClone shallhave the authority to make any statements, representations, warranties,guarantees or commitments (express or implied) of any kind or to take anyaction which shall bind the other Party to a Third Party, without the priorwritten consent of the other Party to do so. Each Party shall use its own discretion with respect to, and shall havecomplete and authoritative control over its employees and the methods and meansby which it performs, its activities under this Agreement (including themanagement of permitted subcontractors).

####  

### (f)                                    This Agreement maybe executed in two (2) or more counterparts, each of which shall be deemed anoriginal, but all of which together shall constitute one and the sameinstrument.

###  

## **17.16****                ****Whole Agreement**

##  

This Agreement and the Schedules referred to inthis Agreement constitute the entire agreement between the Parties with respectto the subject matter of this Agreement,

 

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and supersede all previous understandings,arrangements and agreements with respect to the subject matter of thisAgreement, whether written or oral.  EachParty acknowledges that in entering into this Agreement it has not relied onany representation, warranty, collateral contract or other assurance (exceptthose expressly set out in this Agreement together with the Schedules) made byor on behalf of any other Party before the signature of this Agreement.  Each Party waives all rights and remedieswhich, but for this Article 17.16, might otherwise be available to it inrespect of any such representation, warranty, collateral contract or otherassurance.

 

## **17.17****                ****HSR Filing**

##  

### (a)                                  To the extent necessary at any timeduring the term of this Agreement, each of UCB and ImClone will promptly filewith the United States Federal Trade Commission and the Antitrust Division ofthe United States Department of Justice, any HSR Filing required of it in thereasonable opinion of both Parties under the HSR Act with respect to thetransactions contemplated hereby.  TheParties will co-operate with one another to assess the necessity of any suchHSR Filing and, to the extent necessary, co-operate with one another in the preparationand management of any such HSR Filing and the outcome thereof.  Each Party will be responsible for its owncosts, expenses, and filing fees (as an acquiring person) associated with anyHSR Filing.

###  

### (b)                                 In respect of any HSR Filing, each of UCBand ImClone will use its [***]  [Confidential Treatment Required] to address any concern on the part ofany court or government authority regarding the legality of the proposedtransaction, including co-operating in good faith with any government investigationand the prompt production of documents and information demanded by any secondrequest for documents and of witnesses if requested.

 

 

**IN WITNESS WHEREOF**, the dulyauthorised representatives of the Parties have executed this Agreement as ofthe date first set out above.

 

 
| **UCB S.A.** | **IMCLONE SYSTEMS INCORPORATED**          |
|--------------|-------------------------------------------|
| ** **   | ** **                                |
| By:          | ROCH DOLIVEUX                             |   | By: | MICHAEL HOWERTON |
|         |                                      |   |   |   |
| Name:        | ROCH DOLIVEUX                             |   | Name: | MICHAEL HOWERTON |
|         |                                      |   |   |   |
| Title:       | CHAIRMAN OF THE EXECUTIVE COMMITTEE       |   | Title: | CHIEF FINANCIAL OFFICER |
|         |                                      |   |   |   |
|         |                                      |   |   |   |
| By:          | ROBERT J. TRAINOR                         |   |   |   |
|         |                                      |   |   |   |
| Name:        | ROBERT J. TRAINOR                         |   |   |   |
|         |                                      |   |   |   |
| Title:       | SENIOR VICE PRESIDENT AND GENERAL COUNSEL |   |   |   |

 

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**SCHEDULE****1**

 

**PATENTRIGHTS AND TRADEMARKS**

 

**Schedule 1Part 1: UCB In-Licences**

 

1                                          [***]  [Confidential Treatment Required]

 

 

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**Schedule 1****Part 2: ImClone In-Licences**

 

1                                          [***]  [Confidential Treatment Required]

 

 

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**Schedule 1Part 3: UCB Patent Rights and UCB Company Marks**

 

UCB CORE PATENT RIGHTS

 

[***]   [Confidential Treatment Required]

 

 

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UCB PATENT RIGHTS

 

[***]   [Confidential Treatment Required]

 

 

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[***]   [Confidential Treatment Required]

 

 

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[***]   [Confidential Treatment Required]

 

 

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[***]   [Confidential Treatment Required]

 

 

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[***]   [Confidential Treatment Required]

 

 

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[***]  [Confidential Treatment Required]

 

 

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[***]  [Confidential Treatment Required]

 

 

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[***]  [Confidential Treatment Required]

 

 

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[***]   [Confidential Treatment Required]

 

 

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UCB COMPANY MARKS

 

TheUCB Company Marks are the word mark “UCB” and the corporate logo set out below.

 

 

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**Schedule 1Part 4: ImClone Patent Rights and ImClone Company Marks**

 

IMCLONE CORE PATENT RIGHTS

 

[***]   [Confidential Treatment Required]

 

[***]   [Confidential Treatment Required]

 

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IMCLONE PATENT RIGHTS

 

[***]   [Confidential Treatment Required]

 

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IMCLONE COMPANY MARKS

 

TheImClone Company Marks are the word mark “IMCLONE SYSTEMS” and the corporatelogo set out below.

 

 

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**SCHEDULE****2**

 

**FINANCIALPLANNING, ACCOUNTING AND REPORTING**

 

[***]   [Confidential Treatment Required]

 

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**SCHEDULE****3**

 

**OUTLINE FORTHE DEVELOPMENT PLAN**

 

[***]   [Confidential Treatment Required]

 

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**SCHEDULE 4**

 

**EXISTINGSUPPLY AGREEMENTS**

 

[***]   [Confidential Treatment Required]

 

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