PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
`
`by and between
`
`IVAX INTERNATIONAL GMBH,
`a Swiss corporation
`and
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`ARES TRADINGS.A.,
`a Swiss corporation
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`10/16/02
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`Merck 2077
`TWi v Merck
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`IPR2023-00049
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`l.
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`TABLE OF CONTENTS
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`DO Tih OS coscescessseocescsuecesazanses usps eseaanee eee eR RN WENGE cae TE A aa SaNNE aT AE ONES E NS TRG ERROR 2 4,
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`Development arid Remistratins: ossscsnncsanansnasseriansecsnssansverenrenneteninssensessoronseuiveneessenenanniesie 17
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`ae See ii txelsile 00) | Bneeemarerer rnp Pern rer eo Ter erry TT Cheer creer eer rrr oreeCOT PCr Or 17
`SZ; POU LACVOICI CONTI oars exreercneenresenenercenanonararrsrneaneeRneenenEErennn 18
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`4.35 Develonmient and RegisterBOOS cession 19
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`Ls) Conidentialityicsss scpcvessyanscns sm as.axssamepenwoes sareredeene mizeseckeumegneusnunmms cies 30
`13.2 Effect of Assignment of Rights ..........2....c00cs0e0s Seaman uemenees wrmmaeweurcaptermusris 30
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`I3.
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`PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
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`This Product Development and License Agreementis entered into and made
`effective as of theEFFECTIVE DATE,by and between [VAX International GmbH, a Swiss
`corporation (“LICENSOR”) locatedat Haupt Platz 16, 8640 Rapperswil, Switzerland, and ARES
`TRADINGS.A. (“LICENSEE”), a Swiss corporation located at Chateau de Vaumarcus, 2028
`Vaumarcus, Switzerland.
`
`RECITALS
`
`LICENSEEand LICENSORdesire for LICENSOR and its AFFILIATES
`F,
`to develop an oral formulation ofcladribine foruse in treating multiple sclerosis and to obtain
`satisfactory intellectual property protection for such formulation.
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`10/16/02
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`Definitions. Capitalized terms shall have the meaning set forth below.
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`“CLINICAL TRIAL”shall meanatrial of a FINAL PRODUCTin humansubjects
`conducted byor on behalf of LICENSEEorits AFFILIATES in order to obtain data concerning
`the dose, safety and/or efficacy of theFINAL PRODUCTthat LICENSEEdetermines maybe
`reasonably necessary or appropriate to receive HEALTH AUTHORITY APPROVALSfor the
`FINAL PRODUCT.
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`“CONFIDENTIAL INFORMATION” shall mean(i) any information marked
`“confidential” or “proprietary,” and (ii) any informationthat, by the nature of the information or
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`the circumstances surroundingits disclosure, ought, in good faith, to be treated as confidential.
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`“LICENSED PRODUCiI” shall mean cladribine, also knownas 2-cDA.
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`LOfT 6/02
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`Development and Registration.
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`LICENSEE shall use COMMERCIALLY
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`REASONABLE EFFORTSto conduct CLINICAL TRIALS, obtain necessary HEALTH
`REGISTRATION APPROVALSand market the FINAL PRODUCT.
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`4.2
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`Joint Development Committee.
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`Formation. Within thirty (30) days after the EFFECTIVE DATE,the
`4.2.1
`parties will form a committee (the “JOINT DEVELOPMENT COMMITTEE”) comprising at
`least two representatives from each party.
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`4.2.3 Meetings. The JOINT DEVELOPMENT COMMITTEEshall holdits first
`meeting in person within sixty (60) days after the EFFECTIVE DATE. Thereafter, the JOINT
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`DEVELOPMENT COMMITTEEwill meet as often as necessary
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`LICENSORshall use DILIGENT EFFORTSdevelop anoral dosage formulation ofthe FINAL
`PRODUCTintablet or capsule form suitable for use in CLINICAL TRIALSand for commercial
`ale
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`LICENSOR shall provide monthly written
`reports regarding the progress of the PK STUDY andshall, following completion of the PK
`STUDY, provide(i) a final report regarding the PK STUDY
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`4.3.2.3 Clinical Trial Supplies. LICENSORshall supply to LICENSEE
`such amounts of (1) CLINICAL TRIAL materials including the FINAL PRODUCT
`solely for use in CLINICAL TRIALS necessary forHEALTH AUTHORITY APPROVALS; and
`(ii) appropriate placebo material, all as agreed bythe parties to be reasonablyrequired to enable
`LICENSEEto carry out the CLINICAL TRIALSnecessary forHEALTH AUTHORITY
`APPROVALS.
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`4.3.3.1 Clinical Development. Except as set forth in Section 4.3.2, as of
`the EFFECTIVE DATE, LICENSEE shall assumeall responsibilities and costs associated with
`statistics and data management, regulatoryaffairs, clinical quality assurance, safety studies,
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`toxicology and the clinical development of the FINAL PRODUCT. CLINICAL TRIALS except
`for the PK STUDYwill be conducted by LICENSEEunder LICENSEE’s Investigational New
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`Drug Application.
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`to LICENSEE’s progress in these efforts.
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`Commercialization Efforts. Following LICENSOR’s completionofits development
`2.
`obligations underSection 4.3.2, subject to Section 15.4 LICENSEE shall use
`COMMERCIALLY REASONABLEEFFORTS to conduct CLINICAL TRIALS,including,
`withoutlimitation, to initiate PHASE III CLINICAL TRIALS, obtain necessary HEALTH
`AUTHORITY APPROVALSand market the FINAL PRODUCT inthe United States andall
`MAJOR EUROPEAN COUNTRIES. LICENSEEshall keep LICENSORgenerally informed as
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`13;
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`Confidentiality.
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`Confidentiality. CONFIDENTIAL INFORMATIONshall be safeguarded by the
`13.1.
`recipient, shall not be disclosed to third parties and shall be made available only to recipient’s
`employees or independent contractors who agree in writing to equivalent conditions and who
`have a need to knowthe informationfor the purposes specified under this AGREEMENT.All
`CONFIDENTIAL INFORMATIONshall remain the property of and be returned to the disclosing
`party within thirty (30) days of termination of this AGREEMENT. These mutual obligations of
`confidentiality shall apply for a period of three (3) years after the expiration or termination ofthis
`AGREEMENT,but such obligations shall not apply to any information that:
`
`(i)
`
`(ii)
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`(iii)
`
`(iv)
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`is or hereafter becomes generally available to the public other than by
`reason of any default with respect to a confidentiality obligation underthis
`AGREEMENT;or
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`was already known to the recipient as evidenced by prior written
`documentsin its possession; or
`is disclosed to the recipient by a third party whois not in default of any
`confidentiality obligation to the disclosing party hereunder; or
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`is developed by or on behalfof the receiving party, without reliance on
`CONFIDENTIAL INFORMATIONreceived hereunder.
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`The obligations of non-disclosure contained herein shall not prevent the disclosure
`of CONFIDENTIAL INFORMATIONthat:
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`(i)
`(ii)
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`(iii)
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`(iv)
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`has been approved in writing for publication by each ofthe parties; or
`is required to be disclosed to governmental organizations in compliance
`with applicable laws or regulations in connection with the manufacture or
`sale of the FINAL PRODUCT covered by this AGREEMENT,provided
`that the recipient shall make reasonable efforts to have the disclosed
`CONFIDENTIAL INFORMATIONkept confidential by said government
`organization; or
`
`is otherwise required to be disclosed in compliance with applicable laws or
`regulations or order by a court or other regulatory body having competent
`jurisdiction, provided that the recipient will give prompt notice to the
`discloser of such requirement to disclose and will permit the discloser an
`opportunity to oppose such requirement; or
`
`is product-related information, which is reasonably required to be
`disclosed in connection with obtaining HEALTH AUTHORITY
`APPROVALSor marketing of the FINAL PRODUCTcovered bythis
`AGREEMENT.
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`In the event that any rights under the LICENSED
`Effect of Assignment of Rights.
`13.2
`TECHNOLOGYare assigned to LICENSEEunder the terms of this AGREEMENT,all
`CONFIDENTIAL INFORMATIONrelated to such LICENSED TECHNOLOGYshall be
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`deemed LICENSEE’s CONFIDENTIAL INFORMATION, and LICENSOR’s obligations with
`regard to such CONFIDENTIAL INFORMATIONshall becomeperpetual.
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`IN WITNESS WHEREOF,the parties have executed this AGREEMENTbytheir duly
`authorized representatives as of the date set forth below.
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`IVAX INTERNATIONAL GMBH
`
`ARES T By:
`
`:
`By:
`y Schetfele
`Name: li
`Title: Managing Director
`
`Name: Leon Bushara
`Title: Authorized Representative
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`Date:_16 October 02
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`Date:__16 October 02
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`10/16/02
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`~37-
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