Collaboration Agreement

Exhibit 4.11

EXECUTION VERSION

COLLABORATIONAGREEMENT

This CollaborationAgreement is made and entered into as of April 30,  2001 by and among Chiron Behring GmbH & Co, a company incorporated in Germany,with offices at Emil von Behring Strasse 76, 35041 Marburg, Germany (“Chiron Behring”), Chiron S.p.A., a companyincorporated in Italy, with offices at Via Fiorentina 1, 53100 Siena, Italy (“Chiron S.p.A.”, and together with ChironBehring GmbH & Co, “Chiron”),Rhein Biotech N.V., a company incorporated in the Netherlands, with offices atGaetano Martinolaan 95, 6229 GS Maastricht, The Netherlands (“Rhein Biotech”), and GreenCross VaccineCorporation, a company incorporated in the Republic of Korea, with offices at303 Bojung-Ri, Koosung-Eup, Yongin 449-770, Republic of Korea (“GCVC”, and together with Rhein Biotech, “Rhein Biotech and GCVC”).

RECITALS

A.   WHEREAS, Chiron and Rhein Biotech each hasdeveloped expertise in the fields of vaccine research, development andmanufacturing.

B.   WHEREAS, Chiron and Rhein Biotech enteredinto a Letter of Intent dated as of December 1, 2000 (the “Letter ofIntent”) with respect to their intent to co-develop and manufacture one or morenew pentavalent combination vaccines for pediatric use.

C.   WHEREAS, Chiron, Rhein Biotech and GCVCentered into a Materials Transfer Agreement effective as of December 11,2000 (the “Materials Transfer Agreement”) with respect to their respectiverights and obligations in connection with any materials transferred inconnection with the project contemplated by the Letter of Intent.

D.   WHEREAS, Chiron, Rhein Biotech and GCVCwish to collaborate on the research, development, manufacturing andcommercialization of one or more new pentavalent combination vaccines forpediatric use on the terms and conditions set forth herein with a view toreducing duplicative, unnecessary costs, exchanging ideas and developingresulting products and technologies more rapidly than would otherwise be thecase.

NOWTHEREFORE in consideration of the premises and other good andvaluable consideration, Chiron and Rhein Biotech and GCVC agree as follows.

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ARTICLE 2
COLLABORATION

2.1                  Collaboration. Chiron,Rhein Biotech and GCVC shall establish a collaboration in the Field (the “Collaboration”)subject to the terms and conditions set forth in this Collaboration Agreement.The Parties shall collaborate on research, development and commercialization ofthe Whole Cell Product and, subject to the terms of Section 2.5, of theAcellular Product, all as more fully set forth in this Collaboration Agreement

2.2                  Annual Plan andBudget for 2001. Attached as Schedule I hereto is the Annual Plan andBudget for the year 2001, which shall be deemed to have been approved by theParties.

2.3                  Level of Effort.Each Party shall use commercially reasonable efforts to perform the duties andobligations assigned to it under this Collaboration Agreement and the AnnualPlans and Budgets and shall employ at least the level of effort and care thatsuch Party would use in performing similar activities in connection with itsown internal projects with comparable risk/reward profiles.

2.4                  Commitment toAnnual Plan and Budget. Each Party shall use and shall cause its Affiliatesto use all reasonable efforts to conduct its activities in accordance with andwithin the parameters set by the Annual Plan and Budget, including withoutlimitation, making all investment in the Collaboration necessary and inaccordance with the Investment Plan attached as Schedule L and the timelinesfor the Collaboration set forth in each Annual Plan and Budget and theCollaboration and Development Plan in order to meet the levels of production ofthe Product set forth in each Annual Plan and Budget.

2.5                  AcellularProduct. The Parties agree that they shall collaborate exclusively for a period of twelve months from theEffective Date to evaluate alternatives for implementation of the Collaborationwith respect to the Acellular Product. The provisions in the Collaboration andDevelopment Plan with respect to the Acellular Product shall be used as a basisfor such evaluation. If either Party, in its sole discretion, determines duringsuch twelve month evaluation that the Collaboration with respect to theAcelluar Product should not proceed, such Party shall notify the other Party inwriting of such determination and the Collaboration with respect to theAcellular Product shall be terminated with immediate effect. For the avoidanceof doubt, all R & DExpenses incurred by either Party prior to any such termination of theCollaboration with respect to the Acellular Product shall be shared by theParties in accordance with the terms of Section 6.2.

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(d)                   establishannually the amount allocable to each FTE for each Party, including allassociated costs, such as salaries, benefits, lab materials and supplies,non-capitalized equipment, depreciation, repair and maintenance and otherordinary direct expenses related to research and development activities.

(e)                    considerand determine whether and when to initiate clinical studies of the Product inhumans;

(f)                      considerand determine whether it is necessary or appropriate for the Parties to obtainaccess to intellectual property or technologies Controlled by Third Partiesand, if so, review and approve the terms of any proposed license or similaragreement;

(g)                   considerand determine whether it is appropriate to grant to Third Parties any licensesor other rights with respect to Collaboration Technology;

(h)                   reviewand approve the publication of any Collaboration Technology;

(i)                       considerand determine a patent strategy for Collaboration Technology;

(j)                       ingeneral, to direct the research, development and commercialization of theProduct in accordance with the terms and conditions of this CollaborationAgreement;

(k)                    considerany decisions required to be taken pursuant to the terms of Schedule G to theBulk Supply Agreement and the Supply and Manufacturing Agreement; and

(1)                    reviewon a regular basis the overall pricing policy applied by both Parties.

3.3                  Subcommittees.The Steering Committee may from time to time establish, and delegate certain ofits responsibilities to, one or more subcommittees (including, withoutlimitation, a development committee, a scientific subcommittee, a financesubcommittee, and a marketing subcommittee). Each such subcommittee shall becomprised of an equal number of representatives from Chiron on the one hand andRhein Biotech and GCVC on the other hand. Either Party, in its sole discretion,may from time to time remove one or more of its appointees from any suchsubcommittee and appoint new members with appropriate expertise in their place.

3.4                  Meetings.The Steering Committee shall meet at least once every six months, and eachstanding subcommittee shall meet at least once each calendar quarter atalternatively Rhein Biotech and GCVC’s and Chiron’s facilities or anotherlocation mutually agreed upon by the members of such committee. These meetingsmay be waived or held by telephone or videoconference if agreed by all

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activities conducted by third parties, such as clinical trials. Allmanufacturing costs, such as the costs of producing clinical lots, incurredprior to commercialization shall be shared by the Parties in accordance withthe terms of Section 6.2 and reimbursed on a period basis prior tocommercialization; and (iii) all other costs (other than capital costs butincluding depreciation on such capital expenditures) shall be reimbursed on aperiod basis. Each Party shall use all reasonableefforts to include such costs in the Annual Plan and Budget. In no event shallthe Allowable Expenses for research and development exceed by 120% the AnnualPlan and Budget. Moreover, the Parties agree that the initial estimate of theexpected lifetime development costs of the Collaboration will be in the rangeUnited States Dollars to United States Dollars, generally in accordance withthe terms of Schedule H, which amount shall not be exceeded by more than tenpercent (10%) without prior approval of the Steering Committee.

4.3                  ProductRegistrations. Subject to the terms of Section 3.2 (Functions), eachParty shall prepare, file and control all IND’s and BLA’s in its respectivesales and marketing Territory. Each Party shall consult with, and provide allreasonable assistance to the other with respect to such filings. Each Partyshall be permitted to attend all meetings with the Regulatory Agencies relatingto such filings. Each Party shall hold all Marketing Authorizations in itsrespective sales and marketing Territory in its name on behalf of theCollaboration, unless otherwise required by law.

4.4                  Manufacture ofR&D Supplies. Subject to the terms of Section 3.2 (Functions), themanufacture of all supplies of the Product required for research anddevelopment purposes shall be as provided for in the Collaboration andDevelopment Plan.

ARTICLE5
COMMERCIALIZATION

5.1                  Marketing andSales. Subject to the terms of Section 6.4 (Commercialization), eachParty shall have exclusive rights to market and sell the Product on behalf ofthe Parties in its respective sales and marketing Territory as follows:

(a)                    theRhein Biotech and GCVC territory shall be (i) with respect to the WholeCell Product, supranational institutions, such as WHO, PAHO, GAVI and UNICEF,worldwide (the “Rhein Biotech and GCVC Whole Cell Product Territory”); and (ii) withrespect to the Acellular Product, if any, North Korea and South Korea (the “RheinBiotech and GCVC Acellular Product Territory”)(the Rhein Biotech and GCVC WholeCell Product Territory and the Rhein Biotech and GCVC Acellular ProductTerritory herein jointly referred to as the “Rhein Biotech and GCVC Territory”);and

(b)                   theChiron territory shall be (i) with respect to the Whole Cell Product, theprivate

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costs of any such inspection.

5.5                  Contract Requirements. Chiron and Rhein Biotech and GCVC each shallbe obligated to provide the Chiron Materials and the Rhein Biotech and GCVCMaterials, respectively, in sufficient quantities to fulfill the Minimum Contract Requirements set forth in the BulkSupply Agreement and the Supply and Manufacturing Agreement.

ARTICLE6

PAYMENTS

6.1                  Upfront Payments. Neither Partyshall be obligated to pay any upfront payments to the other Party.

6.2                  R&D Cost-sharing Prior to Commercialization.

(a)                    Rhein Biotechand GCVC and Chiron shall share all R&D Expenses incurred in connectiontheir activities under this Collaboration Agreement as follows:

(i)                        RheinBiotech and GCVC shall pay and Chiron shall pay of the R&D Expensesincurred on or after December 1, 2000 for the Collaboration with respectto the Whole Cell Product; and

(ii)                     RheinBiotech and GCVC shall pay and Chiron shall pay of the R&D Expensesincurred for the Collaboration with respect to the Acellular Product, if any.

(b)                   The agreedaccounting methodologies for determining R&D Expenses are included inSchedule F to this Collaboration Agreement.

(c)                    The agreedreporting requirements with respect to R&D Expenses are included inSchedule F to this Collaboration Agreement. Within 15 days of receipt of suchreports, the Parties shall determine the sum of all R&D Expenses incurredby both Parties, and a single payment shall be made by one Party to the otherParty such that total R&D Expenses are shared in accordance with paragraph(a).

6.3                  Milestone Payments. Neither Party shall beobligated to pay any milestone payments to the other Party.

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ARTICLE 7
INTELLECTUAL PROPERTY

7.1                  Ownership.

(a)                    Contributed Chiron Technology. All ContributedChiron Technology shall be owned solely and exclusively by Chiron. No licensesare granted except as expressly set forth in Article 8 (Licenses) or Article 14(Termination).

(b)                   Contributed Rhein Biotech andGCVC Technology. AllContributed Rhein Biotech and GCVC Technology shall be owned solely andexclusively by Rhein Biotech and GCVC. No licenses are granted except asexpressly set forth in Article 8 (Licenses) or Article 14(Termination).

(c)                    Chiron/Rhein Biotech and GCVCJoint Background Technology. AllChiron/Rhein Biotech and GCVC Joint Background Technology shall continueto be owned jointly by Chiron and Rhein Biotech and GCVC. Except as otherwise expressly setforth in Article 14 (Termination), neither Party shall license itsinterest in Chiron/Rhein Biotech and GCVC Joint Background Technology withoutthe prior written consent of the other Party.

7.2                  Ownership ofCollaboration Technology.

(a)                    Ownership. All Collaboration Technology shall be jointlyowned by Rhein Biotech and GCVC and Chiron.

(b)                   Licenses. Except as otherwise expressly set forth in Article 14(Termination), neither Party shall license its interest in CollaborationTechnology without the prior written consent of the other Party.

7.3                  Patent Filing,Prosecution, Maintenance and Defense. Chiron shall file, prosecute,maintain and defend the Collaboration Patents in accordance with the patentstrategy established by the Steering Committee. Chiron shall keep Rhein Biotechand GCVC fully and promptly informed of the status of the prosecution of suchCollaboration Patents, shall consult with Rhein Biotech and GCVC concerningeach step of such prosecution, and shall afford Rhein Biotech and GCVC timelyopportunity to review and comment on any submission to be made in connectiontherewith. Rhein Biotech and GCVC shall cooperate fully with Chiron inconnection with such matters. All costs and expenses incurred by either Partyin connection therewith shall be shared, with Chiron paying of such costs andRhein Biotech and GCVC paying thereof.

7.4                  InfringementAction By A Third Party. Each Party shall promptly notify the other Partyin the event any legal proceedings are commenced or threatened against

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ARTICLE 8

LICENSES

8.1                  License to Contributed Chiron Technology. Subject to theterms and conditions of this Collaboration Agreement, Chiron hereby grants toRhein Biotech and GCVC a worldwide royalty-free license, without the right tosublicense, under the Contributed Chiron Technology, to make, use and sell theProduct. Such license shall be co-exclusive with Chiron.

8.2                  License to Contributed Rhein Biotech and GCVC Technology.Subject to the terms and conditions of this Collaboration Agreement, RheinBiotech and GCVC hereby grants to Chiron a worldwide royalty-free license,without the right to sublicense, under the Contributed Rhein Biotech and GCVCTechnology, to have made, use and sell the Product. Such license shall beco-exclusive with Rhein Biotech and GCVC.

ARTICLE9
MATERIALS

9.1                  Rhein Biotech and GCVC Materials. Rhein Biotech and GCVC isthe sole and exclusive owner or licensee of the Rhein Biotech and GCVCMaterials. Chiron shall be permitted to use the Rhein Biotech and GCVCMaterials for purposes of the Collaboration and for no other purposeswhatsoever. Chiron shall have no rights or licenses to the Rhein Biotech andGCVC Materials except as expressly set forth herein. Chiron shall not provideany Rhein Biotech and GCVC Materials to any unaffiliated third party withoutthe prior written consent of Rhein Biotech and GCVC. Except as expressly setforth herein or otherwise required by applicable law or regulations, upon thetermination of the Collaboration, Chiron shall cease to use the Rhein Biotechand GCVC Materials and shall, at Rhein Biotech and GCVC’s option and expense,either destroy the Rhein Biotech and GCVC Materials or return the Rhein Biotechand GCVC Materials to Rhein Biotech and GCVC.

9.2                  Chiron Materials. Chiron is the sole and exclusive owner orlicensee of the Chiron Materials. Rhein Biotech and GCVC shall be permitted touse the Chiron Materials for purposes of the Collaboration and for no otherpurposes whatsoever. Rhein Biotech and GCVC shall have no rights or licenses tothe Chiron Materials except as expressly set forth herein. Rhein Biotech andGCVC shall not provide any Chiron Materials to any unaffiliated third partywithout the prior written consent of Chiron. Except as expressly set forthherein or otherwise required by applicable law or regulations, upon thetermination of the Collaboration, Rhein Biotech and GCVC shall cease to use theChiron Materials and shall, at Chiron’s option and expense, either destroy theChiron Materials or return the Chiron Materials to Chiron.

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(a)                    isor hereafter becomes generally available to the public other than by reason ofany breach or default by the Receiving Party of its confidentiality obligationunder this Collaboration Agreement;

(b)                   wasalready known to the Receiving Party (as shown by its written records) prior tothe date of receipt by the Receiving Party from the Disclosing Party hereunderor is independently developed by the Receiving Party (as shown by its writtenrecords) without access to the Disclosing Party’s information; or

(c)                    isdisclosed to the Receiving Party by a third-party not directly or indirectlyunder a duty of confidentiality to the Receiving Party;

(d)                   tothe extent such disclosure is reasonable necessary in connection with thefollowing:

(i)                        filing,prosecuting or maintaining Collaboration Patents;

(ii)                     IND’sor BLAs;

(iii)                  prosecuting or defending litigation;

(iv)                 compliancewith applicable laws or court orders.

Whenever the Receiving Party becomes aware of any state of facts whichwould or might result in disclosure of Confidential Information pursuant tosubparagraph (d) above, it shall, if possible, promptly notify the Partymaking disclosure (the “Disclosing Party”) prior to any such disclosure so thatthe Disclosing Party may seek a protective order or other appropriate remedyand/or waive compliance with the provisions of this Collaboration Agreement. Inany event, if the Receiving Party is unable to promptly notify the DisclosingParty or if such protective order or other remedy is not obtained, or if theDisclosing Party waives compliance with the provisions of this CollaborationAgreement, the Receiving Party will furnish only that portion of theinformation which it is advised by counsel is legally required and willexercise reasonable efforts to obtain assurance that confidential treatmentwill be accorded the Confidential Information.

Each party shall be entitled, in addition to any other right or remedyit may have, at law or in equity, to an injunction, enjoining or restrainingany other party from any violation or threatened violation of this Article 9.

10.3           Return of ConfidentialInformation. Within thirty (30) days after expiration or earliertermination of this Collaboration Agreement, the Receiving Party shall (andshall cause its Affiliates and their respective Representatives to) return tothe Disclosing Party or destroy all documents and tangible items (includingelectronic format) then in its possession which contain, relate to or refer toConfidential Information received from the Disclosing Party; provided, however,that the Receiving Party may retain one copy of each document in its legalfiles solely to permit the Receiving Party to comply with its obligationshereunder.

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S.p.A. of its obligations hereunder have been duly authorized by allnecessary corporate action on the part of each of Chiron Behring and ChironS.p.A.;

(b)                   noconsent, license, permit, approval, order or authorization of, or registration,declaration, qualification or filing with, any foreign, federal, state,provincial or local governmental authority is required to be obtained or madein connection with the execution and delivery of this Collaboration Agreementby Chiron Behring or Chiron S.p.A. or the performance of its obligationshereunder;

(c)                    theexecution and delivery by each of Chiron Behring and Chiron S.p.A. of thisCollaboration Agreement and the performance by each of Chiron Behring andChiron S.p.A. of its obligations hereunder do not conflict with or require theconsent of any third party to any contract, agreement, commitment, covenant,understanding or arrangement to which Chiron Behring or Chiron S.p.A. is aparty;

(e)                    Chironowns or controls the Contributed Chiron Technology free and clear of any liens,claims, encumbrances or charges, and has not previously licensed, assigned orotherwise encumbered its right, title or interest in the Contributed ChironTechnology in the Field.

EACH OF CHIRON BEHRING AND CHIRON S.P.A. DISCLAIMS ALL WARRANTIES,EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OFMERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE ANY AND ALLPRODUCTS OR CHIRON MATERIALS SUPPLIED HEREUNDER, EXCEPT AS EXPRESSLY SET FORTHIN THIS AGREEMENT.

12.2           Representations andWarranties by Rhein Biotech and GCVC. Each of Rhein Biotech and GCVCrepresents and warrants with respect to itself to Chiron, as of the EffectiveDate, that:

(a)                    Eachof Rhein Biotech and GCVC is a corporation and is validly existing and in goodstanding under the laws of its jurisdiction of incorporation; each of RheinBiotech and GCVC has all necessary corporate power to execute, deliver andperform this Collaboration Agreement and to carry out its obligations hereunderthis Collaboration Agreement; and the execution and delivery of thisCollaboration Agreement by each of Rhein Biotech and GCVC and the performanceby each of Rhein Biotech and GCVC of its obligations hereunder have been dulyauthorized by all necessary corporate action on the part of each of RheinBiotech and GCVC;

(b)                   no consent,license, permit, approval, order or authorization of, or

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indemnification is sought (the “Indemnifying Party”) in writingpromptly upon becoming aware of any claim, threatened claim, damage, loss,suit, proceeding or liability (“Claim”) to which such indemnification mayapply. Failure to provide such notice shall constitute a waiver of theIndemnifying Party’s indemnity obligations hereunder if and to the extent theIndemnifying Party is materially damaged thereby. The Indemnifying Party shallhave the right to assume and control the defense of the Claim at its ownexpense. If the right to assume and control the defense is exercised, theIndemnified Party shall have the right to participate in, but not control, suchdefense at its own expense and the Indemnify Party’s indemnity obligationsshall be deemed not to include attorneys’ fees and litigation expenses incurredby the Indemnified Party after the assumption of the defense by theIndemnifying Party. If the Indemnifying Party does not assume the defense ofthe Claim, the Indemnified Party may defend the Claim; provided, that theIndemnified Party will not settle or compromise the Claim without consent ofIndemnifying Party, which consent will not be unreasonably withheld. TheIndemnified Party shall cooperate with Indemnifying Party and will makeavailable to Indemnifying Party all pertinent information under the control ofthe Indemnified Party.

13.4           Waiver of Consequential or Punitive Damages.Subject only to the terms of Section 14.6, no Party shall be liable to anyother Party for any special, incidental or consequential damages, includinglost profits, whether any claim for such recovery is based upon theories ofcontract, negligence, or tort (including strict liability). Each Party herebywaives for itself and its successors and assigns any and all claims for anyspecial, incidental or consequential damages, including lost profits.

13.5           Insurance. Each Party shall obtain andmaintain comprehensive general liability insurance, including product liabilityinsurance, with a reputable and financially secure insurance carrier(s), tocover its activities under this Collaboration Agreement.

ARTICLE14
TERM, TERMINATION AND REMEDY FOR BREACH

14.1           Term. This Collaboration Agreement iseffective as of the date hereof and shall continue indefinitely unlessterminated by either Party in accordance with the terms hereof.

14.2           Mutual Agreement. The Parties may terminatethe Collaboration and the Collaboration Documents at any time by mutual writtenagreement.

14.3           Termination forMaterial Breach. Subject to the terms of this Section 14.3, eitherParty may terminate the Collaboration and the Collaboration Documents by noticewith immediate effect in the event of the occurrence of a Material Breach

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Collaboration and the Collaboration Documents subject to receipt by theChanged Party of written notice of the exercise of such right within ninety(90) days after the completion of such acquisition.

14.5           Effect of Termination In General. Upontermination of the Collaboration and the Collaboration Documents:

(a)                    eachParty shall be obligated to pay 50% of the Residual Expenses; and

(b)                   neitherParty shall be relieved of any obligation which accrued prior to the effectivedate of such termination; in particular, each Party shall remain obligated topay its share of all R&D Expenses incurred by the Parties prior totermination in accordance with the provisions of Section 6.2 and bothParties shall fulfill all payment and other obligations incurred with respectto commercialization of the Product prior to the date of such termination inaccordance with the provisions of Section 6.4.

(c)                    exceptas provided in Section 14.3, Rhein Biotech and GCVC shall not have anycontinuing license to or any other right, title or interest in or to theContributed Chiron Technology, and Chiron shall not have any continuing licenseto or any other right, title or interest in or to the Contributed Rhein Biotechand GCVC Technology;

(d)                   theParties shall continue to jointly own all Collaboration Technology developedprior to such termination; each Party shall have the right to freely licenseits interest in such Collaboration Technology without the consent of the otherParty; and neither Party shall be obligated to pay any royalties to the otherParty for the use of such Collaboration Technology by such Party or itslicensees;

(e)                    Thefollowing provisions shall survive any such termination. Article 6(Payments), Article 7 (Intellectual Property), Article 8 (Licenses), Article 10(Confidentiality), Article 12 (Representations and Warranties), Article 13(Indemnification and Insurance) and Article 14 (Termination).

14.6           Remedies for Other Breaches. The Partiesagree that the remedies set forth below shall be the exclusive remedies withrespect to the following other breaches under the Collaboration Documents:

(a)                    Inthe event (i) either Party shall breach Section 5.5 (ContractRequirements) or (ii) there is a delay in the supply of any Materialsother than by reason of Force Majeure or by reason of any processing failurebeyond the reasonable control of the relevant Party by more than thirty (30)days, the Party in breach or with respect to whose Materials such delay hasoccurred shall pay to the other Party one percent(l%) of the then minimumselling price of the Product per day as a penalty.

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If to Rhein Biotech andGCVC:

GreenCross VaccineCorporation
303 Bojung-Ri, Koosung-Eup
Yongin 449-770
Republic of Korea


Attention: RepresentativeDirector
Facsimile: 82 31 260 9012

with a copy to:

Rhein Biotech N.V.
Gaetano Martinolaan 95
6229 GS Maastricht
The Netherlands


Attention: CEO
Facsimile: 31 43 35 67 899

15.2           EntireAgreement. TheCollaboration Documents constitute the entire agreement between the Partieshereto with respect to the subject matter hereof and supersede any prioragreement whether written or oral.

15.3           ForceMajeure. Neither Party shall be held liable or responsible to theother Party nor be deemed to have defaulted under or breached the Agreement forfailure or delay in fulfilling or performing any term of the Agreement whensuch failure or delay is caused by or results from causes beyond the reasonablecontrol of the affected Party (including but not limited to fire, floods,embargoes, war, acts of war (whether war be declared or not), insurrections,riots, civil commotion, strikes, lockouts or other labor disturbances, acts ofGod or acts, omissions or delays in acting by any governmental authority or theother Party (collectively, “Events of Force Majeure”); provided, however, thatthe affected Party (i) shall immediately notify the other Party of theoccurrence of any such Event of Force Majeure and (ii) shall exert allreasonable efforts to eliminate, cure or overcome any such Event of ForceMajeure and to resume performance of its covenants with all possible speed; andprovided, further, that nothing contained herein shall require any Party tosettle on terms unsatisfactory to such Party any strike, lockout or other labordifficulty, any investigation or proceeding by any governmental authority orany litigation by any third-party. Notwithstanding the foregoing, to the extentthat an Event of Force Majeure continues for a period in excess of six (6) months,the affected Party shall promptly notify in writing the other Party of suchEvent of Force Majeure and within four (4) months of the other Party’sreceipt of such notice, the Parties agree to negotiate in good faith either (i) toresolve the Event of Force Majeure, if possible, (ii) to extend by mutualagreement the time period to resolve, eliminate, cure or overcome such Event of

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15.10    Absence of ExistingCompetition. Each of Rhein Biotech and GCVC represents and warrantsto Chiron that, to the best of its knowledge and belief, neither of RheinBiotech or GCVC nor any Affiliate of either Rhein Biotech or GCVC is presentlyengaged in the business of manufacturing, marketing or distributing theProduct. Chiron represents and warrants to Rhein Biotech and GCVC that, to thebest of its knowledge and belief, neither Chiron nor any Affiliate of Chiron ispresently engaged in the business of manufacturing, marketing or distributingthe Product.

15.11    Absence ofFuture Competition. Except as otherwise provided in thisCollaboration Agreement, each Party covenants and agrees that none of suchParty or any Affiliate of such Party (whether or not such Affiliate hasaccepted a sublicense hereunder and agreed to be bound by the terms hereof) orany of their respective successors in interest shall engage in the business ofdeveloping, manufacturing, marketing or distributing any Product in the Fieldother than through Chiron and Rhein Biotech and GCVC, as contemplated by thisCollaboration Agreement, provided, however, that in the event the Collaborationwith respect to the Acellular Product is terminated pursuant to the terms of Section 2.5,then this Section 15.11 shall not apply to any acellular product in theField.

15.12    EthicalBusiness Practices. Neither Party, nor any person employed by it orrepresenting it, has ever made, offered, provided or authorized, and covenantsthat neither it, nor any person employed by it or representing it, will makeoffer provide or authorize, direct or indirectly, any payment or transfer ofanything of value to any official, representative or employee of any governmentagency or instrumentality, any political party or officer thereof, or anycandidate for public office for the purpose of influencing a decision by any ofthem in their official capacity, and no officer, director, partner, owner,principal, employee, or agent of either Party is an official or employee of agovernmental agency or instrumentality or a government owned company in aposition to influence action or a decision regarding the activities of suchParty contemplated in this Collaboration Agreement. Each Party covenants thatit will inform the other, if and as soon as any person assumes such a positionas an official or employee of a governmental agency or instrumentality orgovernment owned company, while at the same time remaining an officer,director, partner, owner, principal, employee, or agent of such Party.

15.13    Use of Name.No right, express or implied, is granted to either Party by this CollaborationAgreement to use in any manner any trademark or trade name of the other Partyincluding the names “Rhein Biotech and GCVC” and “Chiron” without the priorwritten consent of the owning Party.

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IN WITNESSWHEREOF, the parties have executed this Collaboration Agreement as of the dateset forth above.

CHIRON BEHRING GMBH & CO

 

 

 

RHEIN BIOTECH N.V.

 

 

 

 

 

 

 

 

 

By:

 

/s/ John A. Lambert

 

 

 

By:

 

/s/ Jan Thio

Name:

 

John A. Lambert

 

 

 

Name:

 

Jan Thio

Title:

 

President, Chiron Vaccines

 

 

 

Title:

 

Business Director

 

 

 

 

 

 

 

 

 

CHIRON S.P.A.

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Kees Moonen

By:

 

/s/ John A. Lambert

 

 

 

Name:

 

Kees Moonen

Name:

 

John A. Lambert

 

 

 

Title:

 

Legal Counsel

Title:

 

President, Chiron Vaccines

 

 

 

 

 

 

 

 

 

 

 

 

GREENCROSS VACCINE CORPORATION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Ton Kuiper

 

 

 

 

 

 

Name:

 

Ton Kuiper

 

 

 

 

 

 

Title:

 

Representative Director

 

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SCHEDULE A

DEFINITIONS

For the purposes of theCollaboration Documents the following words and phrases shall have thefollowing meanings:

1.1                  INTENTIONALLYDELETED

1.2                  “Affiliate”, with respect to any person,means any company, entity, joint venture or similar business arrangement whichis controlled by, controlling or under common control with such person, andshall include without limitation any company fifty percent or more of whosevoting stock or participating profit interest is owned or controlled, directlyor indirectly, by such person, and any company which owns or controls, directlyor indirectly, fifty percent or more of such person.

1.3                  “Allowable Expenses” means the fullyburdened, fairly allocated direct and indirect costs and expenses incurred byeither Party in connection with its activities under the CollaborationDocuments, which shall include a reasonable depreciation of employed assets, asdetermined in accordance with the accounting methodologies set forth inSchedule F to the Collaboration Agreement; provided that such costs andexpenses are contemplated by an Annual Plan and Budget approved in accordancewith the provisions of Article 3 of the Collaboration Agreement; provided,however, that any depreciation and amortization associated with any capital expenditureprior to commercialization of the Product shall be treated as an AllowableExpense only to the extent that such expenses combined with the other R &D Expenses do not exceed 120 % of the amount set forth in the Annual Plan andBudget for R & D Expenses. Allowable Expenses shall not include any (a) ExcludedExpenses or (b) any allocation of general and administration expenses orany G& A Markup or (c) any Sales & Marketing Expenses.

1.4                  “Annual Plan and Budget” means, withrespect to any year, a plan for such year which shall include at least thefollowing: planned research and development activities, including timeline andtargeted milestones; planned manufacturing activities; and planned sales andmarketing activities and which shall be prepared and approved in accordancewith the terms of Section 3.2(a) to the Collaboration Agreement.

1.5                  “Batch”shall mean a specific quantity of the Product comprising a number of unitsmutually agreed upon between Chiron and Rhein Biotech and GCVC, and that (a) isintended to have uniform character and quality within specified limits,

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1.15           “Chiron Purchase Order” means written orders from Chiron to RheinBiotech and GCVC which shall specify (a) the quantity of the Productordered, (b) shipping instructions, (c) delivery dates, and (d) deliverydestinations.

1.16           “Chiron Purchase Price” means the price to be paid by Chiron to RheinBiotech and GCVC for the Product in accordance with the terms of Section 5.2 of the Supply andManufacturing Agreement.

1.17           “Chiron/Rhein Biotech andGCVC Joint Background Technology” means

(a)                    allinventions, discoveries, procedures, processes, methods, data, information,results, trade secrets and know-how, whether patentable or otherwise, arisingout of the Materials Transfer Agreement prior to the Effective Date; and

(b)                   allpatents and patent applications claiming such inventions and other technology;all patents issued from such patent applications; and all reissues,confirmations, renewals, extensions, counterparts, divisions, continuations,continuations-in-part, supplemental protection certificates or utility modelsrelating to such patents and patent applications.

1.17           “Chiron Territory” shall have the meaningascribed to it in Section 5.1(b) of the Collaboration Agreement.

1.18           “COGS” stands for cost of goods sold andshall have the meaning ascribed to it in Schedule F to the CollaborationAgreement.

1.19           “Collaboration” shall have the meaningascribed to it in Section 2.1 of the Collaboration Agreement.

1.20           “Collaboration Agreement” means thecollaboration agreement dated as of April 30, 2001 between Chiron andRhein Biotech and GCVC and all schedules, amendments and supplements thereto.

1.21           “Collaboration and Development Plan” meansthe collaboration and development plan attached as Schedule H to theCollaboration Agreement.

1.22           “Collaboration Documents” means theCollaboration Agreement, the Bulk Supply Agreement and the Supply andManufacturing Agreement.

1.23           “Collaboration Inventions” shall have themeaning ascribed to it in the definition of Collaboration Technology.

1.24           “Collaboration Know-How”shall have the meaning ascribed to it in the definition of CollaborationTechnology.

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(b)                   all unpublished scientific, engineering,economic, commercial and other technical data or information, research results, methods, processes,procedures, trade-secrets and know-how relating to the Product which areControlled by Chiron as of the Effective Date.

1.27                       “Contributed Rhein Biotech and GCVC Technology” means:

(a)                    all patents and patent applications Controlledby Rhein Biotech and GCVC as of the Effective Date that cover the Product,including without limitation, the patents and patent applications listed onSchedule C to the Collaboration Agreement; for these purposes a patent or patentapplication shall be deemed to “cover”the Product if the manufacture, use or sale of the Product by Chiron wouldinfringe a claim in such patent or patent application but for the licensescontemplated hereby; all patents issued from such patent applications; and allreissues, confirmations, renewals, extensions, counterparts, divisions,continuations, continuations-in-part, supplemental protection certificates orutility models relating to such patents and patent applications; and

(b)                   all unpublished scientific, engineering,economic, commercial and other technical data or information, research results,methods, processes, procedures, trade-secrets and know-how relating to the Product which are Controlled by Rhein Biotech andGCVC as of the Effective Date.

1.28                       “Controls” or “Controlled” means possession of the right to grantlicenses or sublicenses without violating the terms of any agreement or other arrangement with, or the rights of, any Third Party.

1.29                       “Current Good Manufacturing Practices” or “cGMP” means the good manufacturing practicesrequired by each applicable regulatory authority at any time during the term ofthis Agreement for the manufacture and testing of pharmaceutical materials asapplied solely to the Product.

1.30                       “Effective Date” means the date of the Collaboration Agreement.

1.31                       “ExcludedExpenses” means any and all costs and expenses incurred in defending,settling or otherwise discharging any liability to a third party, including,without limitation, any employee of either Party or their Affiliates, basedupon tortious acts.

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1.43           “Master Batch Record”means, with respect to each Product to be Manufactured hereunder, a formal setof instructions for the Manufacture of such Product.

1.44           “Material Breach” shall have the meaning ascribedto it in Section 14.3 of the Collaboration Agreement.

1.45           “Minimum ContractRequirements” means the quantity of the Product set forth in Schedule B tothe Bulk Supply Agreement and Schedule B to the Manufacturing and SupplyAgreement.

1.46           “Net Sales” means,with respect to either Party, the total gross sales or consideration for theProduct charged to unaffiliated third parties, including without limitation,amounts invoiced for sales of the Product, less the Sales and ReturnAllowances, provided, however, that the selling Party may, at its option,allocate the Sales and Return Allowances based upon accruals estimatedreasonably and consistent with such Party’s standard business practices; andprovided further, however, that if the selling Party elects to utilize suchaccruals, actual deductions will be calculated and, if applicable, a “true-up”made, on an annual basis and to the extent the aggregate amount of suchdeductions is required under the terms of this Agreement to be allocatedbetween countries, such allocation will be in the same proportion as grosssales of the Product realized in each country in the applicable period.

1.47           “Other Revenues” meansany revenues arising out of Collaboration Technology other than Net Sales,including, without limitation, royalties or other amounts paid by Third Partiesfor licenses to Collaboration Technology.

1.48           “Parties” meansChiron and Rhein Biotech and GCVC and “Party” shall mean one of them.

1.49           “Product” means (a) theWhole Cell Product; and (b) to the extent of the Collaboration proceedingin accordance with the terms of Section 2.5 of the CollaborationAgreement, the Acellular Product.

1.50           “Product Addendum”means the addendum attached as Schedule C to the Bulk Supply Agreement and asSchedule C to the Manufacturing andSupply Agreement setting forth the Product Requirements, terms andpresentations for each Product Manufactured under the Bulk Supply Agreement and the Manufacturing and SupplyAgreement.

1.51           “Product Loss Allowance”means the allowances for losses of the finished Product as more specificallyset forth in Schedule F to the Bulk Supply Agreement and the Supply andManufacturing Agreement.

1.52           “Product Requirements”means the Product Specifications, the Master Batch Record and Rhein Biotech andGCVC’s SOPs.

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substances (other than Chiron Materials, which combination shall bedeemed Collaboration Materials).

1.61           “Rhein Biotech and GCVCPurchase Order” means written orders from Rhein Biotech and GCVC to Chironwhich shall specify (a) the quantity of the Bulk Chiron Material ordered, (b) shippinginstructions, (c) delivery dates, and (d) delivery destinations.

1.62           “Rhein Biotech and GCVCPurchase Price” means the price to be paid by Rhein Biotech and GCVC toChiron for the Bulk Chiron Material in accordance with the terms of Section 3.2of the Bulk Supply Agreement.

1.63           “Rhein Biotech and GCVCTerritory” shall have the meaning ascribed to it in Section 5.1 of theCollaboration Agreement.

1.64           “Sales &Marketing Expenses” means the following sales and marketing expenses forthe Product including:

(i)                       Costsassociated with sales representatives such as compensation, benefits, travel,supervision and training of sales representatives, sales meetings and othersales expenses.

(ii)                    Directcosts of marketing, promotion, advertising, professional education, productrelated to public relations, relationships with opinion leaders andprofessional societies, market research and other similar activities.

1.65           “Sales and Return Allowances” means the followingsales and return allowances as determined under US GAAP:

(a)                    normaland customary trade and/or quantity discounts;

(b)                   returns,rebates, credit for product defects actually;

(c)                    tothe extent separately stated on purchase orders and invoices or other documentsof sale and actually taken:

(i)                        importedand export duties;

(ii)                     excise,sales or use taxes;

(iii)                  value added taxes, and othergovernmental charges; and

(d)                   transportation,transit and insurance for transportation, each to the extent separatelyinvoiced and paid by the selling Party.

1.66           “SOPS” mean standard operating procedures forthe Manufacture of the Product which shall be reviewed by both Parties.

1.67           “Steering Committee” shall have the meaningascribed to it in Article 3 of the Collaboration Agreement.

1.68           “Supply and Manufacturing Agreement” meansthe supply and manufacturing agreement dated as of the date of theCollaboration Agreement between Chiron and Rhein Biotech and GCVC, and allschedules, amendments and supplements

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