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`https://www .sec.gov/ Archives/edgar/data/702131 /0001 04596901500128/dex991.txt
`
`<DOCUMENT>
`<TYPE>EX-99.1
`<SEQUENCE>2
`<FILENAME>dex991.txt
`<DESCRIPTION>LICENSE AGREEMENT DATED APRIL 6, 2001
`<TEXT>
`
`<PAGE>
`
`Exhibit 99.1
`
`L i c e n s e A g r e e m e n t
`
`b e t w e e n
`
`H E L S I N N H E A L T H C A R E SA
`
`a n d
`
`MGI Pharma, INC.
`
`f o r
`
`PALONOSETRON
`
`<C>
`
`DEFINITIONS
`GRANT OF RIGHTS AND COMPETITION
`EXCHANGE OF INFORMATION AND IMPROVEMENTS
`DEVELOPMENT AND REGISTRATION OF PRODUCTS
`POST-REGISTRATION DEVELOPMENT
`TRADEMARK OF PRODUCTS
`COMPENSATIONS BY MGI
`MARKETING AND SALE OF PRODUCTS
`RECORDS AND REPORTS
`REPRESENTATIONS AND WARRANTIES
`LIABILITIES, INDEMNITIES AND INSURANCE
`THE PATENTS
`THE SYNTEX AGREEMENT
`
`<PAGE>
`
`TABLE OF CONTENTS
`
`<TABLE>
`<CAPTION>
`
`<S>
`RECITALS
`ARTICLE 1
`ARTICLE 2
`ARTICLE 3
`ARTICLE 4
`ARTICLE 5
`ARTICLE 6
`ARTICLE 7
`ARTICLE 8
`ARTICLE 9
`ARTICLE 10
`ARTICLE 11
`ARTICLE 12
`ARTICLE 13
`
`https://www.sec.gov/Archives/edgar/data/702131/000104596901500128/dex991.txt
`
`<C>
`Page 4
`Page 5
`Page 8
`Page 12
`Page 13
`Page 17
`Page 18
`Page 20
`Page 25
`Page 27
`Page 28
`Page 32
`Dr. Reddy’s Laboratories, Ltd., et al.
`Page 36
`v.
`Page 37
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1043
`
`1/38
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`
`<DOCUMENT>
`<TYPE>EX-99.1
`<SEQUENCE>2
`<FILENAME>dex991.txt
`<DESCRIPTION>LICENSE AGREEMENT DATED APRIL 6, 2001
`<TEXT>
`
`<PAGE>
`
`Exhibit 99.1
`
`L i c e n s e A g r e e m e n t
`
`b e t w e e n
`
`H E L S I N N H E A L T H C A R E SA
`
`a n d
`
`MGI Pharma, INC.
`
`f o r
`
`PALONOSETRON
`
`<C>
`
`DEFINITIONS
`GRANT OF RIGHTS AND COMPETITION
`EXCHANGE OF INFORMATION AND IMPROVEMENTS
`DEVELOPMENT AND REGISTRATION OF PRODUCTS
`POST-REGISTRATION DEVELOPMENT
`TRADEMARK OF PRODUCTS
`COMPENSATIONS BY MGI
`MARKETING AND SALE OF PRODUCTS
`RECORDS AND REPORTS
`REPRESENTATIONS AND WARRANTIES
`LIABILITIES, INDEMNITIES AND INSURANCE
`THE PATENTS
`THE SYNTEX AGREEMENT
`
`<C>
`Page 4
`Page 5
`Page 8
`Page 12
`Page 13
`Page 17
`Page 18
`Page 20
`Page 25
`Page 27
`Page 28
`Page 32
`Page 36
`Page 37
`
`<PAGE>
`
`TABLE OF CONTENTS
`
`<TABLE>
`<CAPTION>
`
`<S>
`RECITALS
`ARTICLE 1
`ARTICLE 2
`ARTICLE 3
`ARTICLE 4
`ARTICLE 5
`ARTICLE 6
`ARTICLE 7
`ARTICLE 8
`ARTICLE 9
`ARTICLE 10
`ARTICLE 11
`ARTICLE 12
`ARTICLE 13
`
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`ARTICLE 14
`ARTICLE 15
`ARTICLE 16
`ARTICLE 17
`ARTICLE 18
`ARTICLE 19
`ARTICLE 20
`ARTICLE 21
`
`https://www.sec.gov/Archives/edgar/data/702131/000104596901500128/dex991.txt
`CONFIDENTIALITY
`FORCE MAJEURE
`TERM
`TERMINATION
`MISCELLANEOUS
`APPENDICES
`LAW TO GOVERN AND ARBITRATION
`ENTIRETY OF AGREEMENT AND SEVERABILITY
`
`FIRST APPENDIX
`SECOND APPENDIX
`THIRD APPENDIX
`FOURTH APPENDIX
`</TABLE>
`
`LIST OF KNOW-HOW ITEMS
`PATENTS
`PRODUCTS
`DEVELOPMENT CHART
`
`<PAGE>
`
`<TABLE>
`<CAPTION>
`
`2
`
`<S>
`FIFTH APPENDIX
`
`<C>
`HHC'S POST-REGISTRATION REGULATORY ACTIVITIES
`
`SIXTH APPENDIX
`SEVENTH APPENDIX
`
`ADVERSE EVENTS REPORTING
`PRODUCTS RECALL PROCEDURE
`
`EIGHT APPENDIX
`NINTH APPENDIX
`TENTH APPENDIX
`</TABLE>
`
`<PAGE>
`
`ESCROW AGREEMENT
`MGI'S UNIT SALES BASE FORECAST - ANNUAL MINIMUM SALES
`PROMOTION AND MARKETING ACTIVITIES
`
`3
`
`Page 38
`Page 39
`Page 40
`Page 40
`Page 43
`Page 45
`Page 46
`Page 47
`
`Page 49
`Page 83
`Page 84
`Page 85
`
`<C>
`Page 86
`
`Page 87
`Page 93
`
`Page 96
`Page 109
`Page 111
`
`THIS AGREEMENT (hereinafter called "Agreement") is effective as of this 6th day
`of April 2001 (hereinafter called "Effective Date"), between HELSINN HEALTHCARE
`SA, a corporation organized and existing under the law of Switzerland and having
`its registered office at Via Pian Scairolo, 6912 Pazzallo, Switzerland
`(hereinafter called "HHC") of the one part, and MGI PHARMA, INC., a corporation
`organized and existing under the law of the state of Minnesota, United States of
`America and having its registered office at 6300 West Old Shakopee Road, Suite
`110, Bloomington, MN 55438-2318, USA (hereinafter called "MGI"), of the other
`part.
`
`RECITALS
`
`a.
`
`HHC carries on business as a licensing company, product developer and
`pharmaceutical trader and, in particular for the purpose of this
`Agreement, has in-licensed from the companies Syntex (U.S.A.) Inc. and F.
`Hoffmann-La Roche AG by means of a License Agreement dated June 23, 1998
`(hereinafter, the "Syntex Agreement") world-wide exclusive rights to
`certain patents and know-how to make, have made, develop, register,
`market, distribute and sell, directly or indirectly, the Compound (as
`hereinafter defined) and pharmaceutical preparations containing said
`Compound as active pharmaceutical ingredient.
`
`b.
`
`MGI carries on business as a pharmaceutical company and, in particular
`for the purpose of this Agreement, represents that it is a reputable
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`pharmaceutical company, having a size and a position on the market
`adequate to effectively market, distribute and sell the Products (as
`hereinafter defined) and that it has the necessary sales force to
`successfully sell the Products in the Field throughout the Territory (as
`hereinafter defined).
`
`c.
`
`d.
`
`<PAGE>
`
`e.
`
`f.
`
`Prior to entering into discussions with HHC, MGI possessed no technology
`and limited information of its own (including publicly available
`information) relating to the Compound and/or the Products. The Parties
`entered on 25th May 2000 into a Secrecy Agreement by means of which HHC
`disclosed to MGI confidential information and data relating to the
`Compound and Products.
`
`The Parties entered on October 5th, 2000 into a Letter of Intent on which
`basis they have performed respective appropriate due diligence for the
`purpose of establishing their interest
`
`4
`
`and willingness to enter into this Agreement, and hereby confirm that (i)
`each has been provided with full and complete access to such information
`as they deemed necessary or appropriate to conduct due diligence, and
`(ii) such due diligence has been completed to their full satisfaction.
`
`MGI now wishes to acquire the right to act as HHC's licensee and
`distributor for the Products in the Territory and HHC is willing to so
`appoint MGI under the terms and conditions hereinafter set forth.
`
`The Parties agree that this preamble constitutes an integral part of this
`Agreement and all capitalized terms used in this preamble shall have the
`meaning as defined in Article 1 hereafter.
`
`NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
`and conditions herein contained, the Parties hereby agree as follows:
`
`ARTICLE 1 - DEFINITIONS
`
`The following terms as used in this Agreement have, unless the context clearly
`indicates otherwise, the following meanings:
`
`1.1
`
`1.2
`
`"Accounting Period" means the quarters ending 31st March, 30th June, 30th
`September and 31st December in each year throughout the term of this
`Agreement.
`
`"Affiliate" means an organization that, whether now or in the future,
`controls, is controlled by or is under common control with a Party. For
`the purposes of this definition, the terms "controls," "controlled by,"
`and "under common control with" as used with respect to any Party, means
`the possession (directly or indirectly) of fifty percent or more of the
`voting stock or other equity interest of a subject entity with the power
`to vote, or the power in fact to control the management decisions of such
`entity through the ownership of securities or by contract or otherwise.
`
`1.3
`
`"Compound" means the active pharmaceutical ingredient
`(3aS-2-[(S)-1-Azabicyclo[2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1H-
`benz[de]isoquinoline hydrochloride, having the generic name palonosetron
`hydrochloride (INN) for use in human medicine.
`
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`<PAGE>
`
`1.4
`
`1.5
`
`1.6
`
`1.7
`
`1.8
`
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`5
`
`"FDA" means the U.S. Food and Drug Administration or any successor
`agency.
`
`"Field" means the prevention of chemotherapy induced nausea and vomiting
`(CINV) in terms of the Regulatory Authorities approved indication.
`
`"HHC's Other Distributors" means any distributor and/or licensee
`appointed by HHC to promote and sell pharmaceutical preparations
`containing the Compound in any country of the world outside the Territory
`and outside the Field in the Territory.
`
`"Improvements" means all improvements) modifications or developments
`relating to the Field and/or to the Product forms subject of this
`Agreement) which might improve the quality or improve consumer acceptance
`and/or patient compliance of the Products. For clarity) except to the
`extent MGI has exercised its right of first refusal under Article 2.6)
`"Improvements" shall not include dosage forms other than the intra-venous
`("I.V.") formulation as shall be described in the Registration and/or
`indications other than within the Field.
`
`"Know-how" means valuable) secret and substantial information regarding
`the Products in the Field) including but not limited to documentation and
`information on file with the FDA or other Regulatory Authority in support
`of the Registration) which may be necessary) useful or advisable to
`enable MGI to promote) market and sell the Products in the Field in the
`Territory) as far as controlled by or available to) and not prohibited to
`be disclosed or licensed by) HHCJ all as listed in the First Appendix
`hereto and as is or will be specified in the documentation which HHC has
`delivered or will deliver to MGI after execution of this Agreement.
`
`1.9
`
`"Net Sales" means the gross sales in local currencies of all Products
`sold in the Territory by MGI and/or its Affiliates) including any local
`Affiliate in Canada) for arm's lenghth sales to any non-Affiliated third
`party less those normal and customary deductions made under Generally
`Accepted Accounting Principles to arrive at Product sales. ***
`
`*** Denotes confidential information that has been omitted from the exhibit and
`filed separately) accompanied by a confidential treatment request) with the
`Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`<PAGE>
`
`1.10
`
`6
`
`"Parties" means HHC and MGI and "Party" means either of them as the
`context indicates.
`
`1.11
`
`"Patent" means (a) the patents and the patent applications licensed or
`assigned to HHC pursuant to the Syntex Agreement) as listed in the Second
`Appendix hereto; (b) all patents in the Territory issuing from said
`applications; (c) any additions) divisions) continuations)
`continuations-in-part) amendments) amalgamations) reissues and
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`re-examinations of such applications or patents in the Territory; (d) any
`confirmation) importation and registration patents thereof in the
`Territory) and (e) any extensions and renewals of all such patents and
`patent applications in the Territory in whatever legal form and by
`whatever legal title they are granted.
`
`1.12
`
`1.13
`
`1.14
`
`"Products" means the pharmaceutical preparations for human use in I.V.
`dosage formJ containing the Compound as an active ingredient in the
`formulation that will be described in the Registration and such other
`formulations for which MGI exercises its right of first refusal pursuant
`to Article 2.6. The current formulation as submitted to the Food and Drug
`Administration of the United States of America in the IND 39J797
`Amendment # 64 and to the Therapeutic Products Programme of Canada in the
`IND 9427-H0836-21C is described in the Third Appendix hereto.
`
`"Registration" means any official approval) or authorization by the
`competent Regulatory Authority of each country in the Territory) which is
`legally required to lawfully market the Products in the Territory)
`including) without limitation) any governmental price approval or
`reimbursement approved under a national health insurance system.
`
`"Regulatory Authority" meansJ with regard to the United States of America
`the United States Food and Drug Administration (FDA) andJ with regard to
`Canada the Therapeutic Products Programme) or any other agency which
`shall be responsible for the issuance of the Registration throughout the
`term of this Agreement.
`
`1.15
`
`"Territory" means the United States of America and its possessions and
`territories (Puerto RicoJ United States Virgin Islands)J and Canada and
`its provinces) possessions and territories.
`
`<PAGE>
`
`1.16
`
`7
`
`"Trademark" means the trademark DEDYS(R) or ONICIT(R), which are and
`shall be HHC's property) or under another trademark to be selected by the
`Parties) it being understood that HHC shall bear reasonable documented
`expenses in connection with such selection) and which shall be HHC's
`property.
`
`ARTICLE 2 - GRANT OF RIGHTS AND COMPETITION
`
`2.1
`
`Subject to all terms and conditions of this Agreement) HHC hereby grants
`MGIJ and MGI hereby accepts) an exclusive) non-transferable and
`non-assignable (except as provided at Article 2.8 here below with regard
`to distribution) promotion and sale of the Products in the Field by a
`local Affiliate of MGI in Canada)J royalty-bearing license under the
`Patents and to use the Know-howJ to distribute) promote) market and sell
`the Products in the Territory for the Field.
`
`Moreover) subject to all terms and conditions of this Agreement) HHC
`hereby grants MGIJ which hereby accepts) an exclusive) non-transferable
`and non-assignable (except as provided at Article 2.8 here below with
`regard to distribution) promotion and sale of the Products in the Field
`by a local Affiliate of MGI in Canada)J royalty-bearing license to affix
`the Trademark to the Products and to use it in connection with the
`distribution) promotion) marketing and sale of the Products in the
`Territory for the Field.
`
`The exclusivity granted pursuant to this Article 2 means that only MGI
`2.2
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`may be licensed by HHC to distribute) promoteJ market and sell the
`Products in the Territory for the Field.
`
`***
`
`2.3
`
`MGI agrees not to knowingly marketJ shipJ distribute) promoteJ sell or
`otherwise put into circulation the Products outside the Territory and/or
`outside the Field and to expressly and consistently inform distributors
`and/or wholesalers for the Products) by warning letters or
`
`*** Denotes confidential information that has been omitted from the exhibit and
`filed separately) accompanied by a confidential treatment requestJ with the
`Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`<PAGE>
`
`8
`
`other appropriate and effective meansJ that the distribution and sale of
`the Products outside the Territory and/or outside the Field is prohibited
`and to enforce such prohibition as and when necessary. In the event that
`MGI enters into any agreements with its distributors and/or wholesalers
`for the Products) it shall use commercially reasonable efforts to include
`in any and all said agreements appropriate provisions prohibiting) to the
`maximum extent permissible under applicable laws and regulations) that
`the Products are distributed outside the Territory and/or outside the
`FieldJ and to enforce such provisions as and when necessary. Moreover)
`MGI undertakes to pass on to HHC any request for the Products coming to
`MGI from any party or for sale outside the Territory.
`
`***
`
`MGI acknowledges and agrees that it shall not have the right to
`manufacture) directly or indirectly) the Compound and/or the Products. In
`order to maintain at all times the highest quality for the Products and
`to ensure a scientifically proper and safe exploitation of the licensed
`Know-how and Patents and in order to maintain and to protect the goodwill
`of the Trademark) MGI undertakes to purchase all of its Products'
`requirements exclusively from a source indicated or approved by HHC;
`provided that such source meets all requirements of applicable Regulatory
`Authorities and specifications for the Products applicable in the
`Territory.
`
`2.4
`
`2.5
`
`2.6
`
`The Parties hereby acknowledge and agree that the development and
`marketing of an oral formulation of the Compound will be useful for
`enlarging the market of pharmaceutical preparations containing the
`Compound in the Field and undertake to discuss in good faith on the
`timingJ costs and any other conditions relevant to the development)
`registration and marketing of such oral formulation. In addition) HHC
`shall offer to MGI a first negotiation right for the Territory (or some
`portion thereof) to distribute) promoteJ market and sell any new dosage
`form(s) and/or formulation(s) (other than the I.V. formulation as shall
`be described in the Registration) of the Products in the Field (i)
`becoming available to HHC throughout the term of this Agreement and which
`HHC is free to offer in the Territory (or a portion thereof) or (ii)
`which development and marketing may be deemed of interest for the Parties
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`
`or any of them. ***
`
`*** Denotes confidential information that has been omitted from the exhibit and
`filed separately) accompanied by a confidential treatment request) with the
`Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`<PAGE>
`
`2.7
`
`9
`
`MGI acknowledges that there are or there may be different uses or
`indications of the Products and that the rights and licenses hereby
`granted by HHC are limited to the Field. HHC retains the right to) and
`shall be free to exploit at its own discretion into and outside the
`Territory) any and all uses or indications of the Products outside the
`Field) in whichever dosage form and/or formulation HHC may deem fit)
`including but not limited to I.V.J and MGI shall have no rights in any
`respect whatsoever to such uses and/or indications outside the Field)
`provided that HHC shall not be entitled to use the Trademark or
`trademarks which are confusingly similar to the Trademark in respect of
`marketing and sale in the Territory of said uses and/or indications of
`the Products outside the Fieldj provided that such exploitation does not
`conflict with) or otherwise violate the terms and conditions of this
`Agreement.
`
`2.8
`
`MGI shall not have the right to sublicense or otherwise transfer any of
`its rights and/or obligations hereunderj provided that MGI shall be
`entitled to engage co-promotion partners in the United States) subject to
`HHC's prior approval) not to be unreasonably withheld. Moreover) MGI
`shall not have the right to sub-contract any of its rights and/or
`obligations hereunder) provided however that MGI shall be entitled to
`have the logistics and warehousing activities (excluding however
`invoicing and billing to customers) relevant to the Products carried out
`by its Affiliates or by third parties in the Territory. It is understood
`
`<PAGE>
`
`10
`
`that MGI shall have the right to have the Products distributed) promoted
`and sold in Canada by its local Affiliate) whose name and address) and
`any change thereof) shall be timely notified to HHC.
`
`MGI undertakes and warrants that its Affiliate in Canada shall strictly
`comply with MGI's applicable obligations and warranties stated in this
`Agreement and any breach of such obligations and/or warranties by such
`Affiliate shall be regarded in all respects and in particular for the
`purposes of Articles 11 and 17 hereunder) as a breach by MGI.
`Correspondingly) MGI shall be fully responsible towards HHC for any
`action and/or omission of its said Affiliate) and shall defend) indemnify
`and keep HHC wholly free and harmless from any connected claims) damages)
`liabilities) losses) costs and/or expenses. Moreover) MGI expressly
`undertakes and warrants that any agreement with respect to the Products
`between itself and its Affiliate in Canada shall be fully consistent with
`this Agreement and undertakes to send to HHCJ upon HHC's written request)
`a copy of any said executed agreement (with economic terms redacted) for
`the purpose of enabling HHC to verify compliance with terms and
`conditions hereof.
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`2.9
`
`MGI shall be permitted to disclose to its Affiliate in Canada such
`Know-how and other relevant information to the extent strictly necessary
`and appropriate to correctly carry out its obligations hereunder,
`provided however that any such disclosure shall be made only under a
`confidentiality agreement, for the benefit of and approved in writing by
`HHC, having terms at least as restrictive as those provided herein.
`
`MGI shall not enter into any agreement with third parties with respect to
`the Compound and/or the Products, except as may be necessary for the
`purpose of a full and correct exploitation of the Products in accordance
`with all terms and conditions of this Agreement. Upon HHC's written
`request, MGI shall send to HHC a copy of any said executed agreement
`(with economic terms redacted) for the purpose of enabling HHC to verify
`compliance with terms and conditions hereof. Nothing in this Agreement
`shall be construed as giving MGI any right to use or otherwise deal with
`the Know-how, the Patents and/or any other information received hereunder
`for purposes other than those of distributing, promoting, marketing and
`selling the Products in the Territory for the Field in accordance with
`the terms and conditions of this Agreement. In particular, and without
`limiting the generality of the foregoing, MGI hereby undertakes not to
`file any application for the Registration of generics of the Products in
`the Territory or outside the Territory throughout the term of this
`Agreement.
`
`2.10 MGI shall promptly inform HHC of any misappropriation, or threatened or
`presumed misappropriation of the Know-how which comes to its attention.
`HHC will decide on the steps to be taken after having discussed the case
`with MGI and MGI shall assist, bearing
`
`<PAGE>
`
`2.11
`
`2.12
`
`11
`
`exclusively its own internal costs and HHC bearing MGI's reasonable
`out-of-pocket costs, HHC in taking legal action, if deemed necessary by
`HHC, against such misappropriation.
`
`Each Party shall promptly and fully inform the other if it has a
`reasonable basis to believe that there have been unauthorized sales of
`the Products into or outside the Territory, and shall use practical
`efforts with all such persons to act consistently with the terms and
`conditions of this Agreement.
`
`In the event that MGI fails to respect the limitations of the licenses
`granted under this Article 2 and MGI or its Canadian Affiliate knowingly
`distributes Products outside the Territory and/or outside the Field, or
`fails to enforce appropriate prohibitions on such distribution of
`Products outside the Territory and/or outside the Field by its
`distributors and/or wholesalers in accordance with Article 2.3 here
`above, MGI shall be deemed to be in material default, and HHC shall have
`the right, in its sole discretion, to terminate this Agreement by written
`notice to MGI, which breach is not cured within a sixty (60) days notice
`period.
`
`ARTICLE 3 - EXCHANGE OF INFORMATION AND IMPROVEMENTS
`
`3.1
`
`Throughout the term of this Agreement, HHC shall supply MGI in writing
`and free of charge with any relevant Know-how, in addition to that
`already supplied at the Effective Date hereof, which may be or become
`available to HHC and which HHC is free to disclose. Notwithstanding the
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`foregoing, nothing in this Agreement shall require HHC to obtain
`additional Know-how from third parties.
`
`In the event that MGI should require technical assistance in connection
`with its initial sale of the Products in the Territory, HHC will use its
`commercially reasonable efforts to assist MGI for reasonable periods of
`time and at times convenient to HHC.
`
`MGI shall supply HHC in writing or by any other appropriate support, free
`of charge, with any and all technical and/or scientific information and
`data relating to the Products and/or the Compound, as soon as they are or
`become available to MGI throughout the term of this Agreement. MGI shall
`communicate any such information and data to HHC and MGI shall use such
`information and data for the purpose of the distribution, promotion and
`sale of the Products in the Territory for the Field in accordance with
`the terms and conditions of this Agreement. HHC shall have the right to
`use such information and data for the purpose of its business and to
`disclose the same to HHC's Affiliates and to HHC's Other Distributors,
`which in turn shall have the right to use them for the purpose of the
`distribution, promotion
`
`12
`
`3.2
`
`<PAGE>
`
`and sale of pharmaceutical preparations containing the Compound outside
`the Territory and outside the Field in the Territory.
`
`3.3 MGI's rights hereunder shall include any Improvement carried out by or
`which may be discovered, developed, invented or acquired by HHC, for use
`in accordance with the terms and conditions of this Agreement. Any
`Improvement which may be carried out by or which may be discovered,
`developed, invented or acquired by MGI, its officers, agents or
`employees, may be used by MGI for the purpose of the distribution,
`promotion and sale of the Products in the Territory for the Field in
`accordance with the terms and conditions of this Agreement and will be
`promptly disclosed and is hereby automatically licensed free of charge to
`HHC on an exclusive basis even as to MGI (except for those MGI's
`activities described here above) and HHC shall have the right to
`sublicense the above Improvements to HHC's Affiliates and to HHC's Other
`Distributors for use outside the Territory and outside the Field in the
`Territory. MGI shall not incur any obligation to any third party which
`may prohibit or impair its ability to disclose and license Improvements
`to HHC.
`
`3.4
`
`All Know-how, Improvements and/or other information and data disclosed to
`MGI hereunder are at all times and shall after expiration or termination
`of this Agreement for any reason remain HHC's sole and exclusive
`property.
`
`ARTICLE 4 - DEVELOPMENT AND REGISTRATION OF PRODUCTS
`
`4.1
`
`MGI hereby acknowledges and agrees that
`
`4.1.1 at the Effective Date of this Agreement the Products are under
`development by HHC for the purpose of submitting the relevant
`Registration application to the Regulatory Authorities of the
`Territory,
`
`4.1.2
`
`the development of the Products by HHC may be interrupted or
`discontinued by HHC as set forth in Article 4.2, if said
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`development becomes commercially unreasonable) or the relevant
`results may be negative or unfavorable)
`
`4.1.3
`
`the development work presently carried out will not necessarily
`result in the grant of the Registration of the Products and
`
`4.1.4 HHC makes no warranty and nothing in this Agreement may or shall
`be construed as a warranty by HHC that the Products will obtain
`the Registration or that a
`
`<PAGE>
`
`4.2
`
`13
`
`Product can be developed and registered from the Know-how and MGI
`shall have no claim against HHC arising out of any delay or
`refusal by the Regulatory Authorities to issue the Registration in
`any way whatsoever.
`
`HHC will use commercially reasonable efforts to complete the development
`of the Products in accordance with the Development Chart attached as
`Fourth Appendix hereto andJ subject to satisfactory development of the
`Products and provided that no unforeseeable events occur or additional
`requests are made by the Regulatory Authorities with respect to the
`development of the Products described in the Development Chart hereto
`attached) to file the NDA for the Products in the United States of
`America not later than *** ***
`
`*** Denotes confidential information that has been omitted from the exhibit and
`filed separately) accompanied by a confidential treatment request) with the
`Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities
`Exchange Act of 1934.
`
`<PAGE>
`
`4.3
`
`4.4
`
`14
`
`Applications for the Registration in the Territory shall be filed by HHC
`in its own name and at its own expenses. HHC shall also pay all
`administrative fees for the maintenance in force of the Registration
`throughout the term of this Agreement.
`
`MGI expressly acknowledges and agrees that HHC is and shall at all times
`remain the sole and exclusive owner of the Registrations and that
`ownership of said Registrations and any and all rightsJ title and
`interest (including any accompanying goodwill) areJ and shall at all
`times remain, vested in HHC.
`
`4.5
`
`After approval of the NDA for the Products in the United States and
`compliance by MGI with the provision of Article 7.1.5 hereunder) MGI
`shall be appointed by HHC as HHC's agent with respect to the NDA for the
`Products in the Field ("FDA Agent") and shall manage and carry out on
`behalf of HHC all relevant communications and relations with the FDA. In
`addition) MGI shall be entitled to participate in all negotiations and
`discussions between HHC and the FDA regarding any labeling for the
`Products in the Field and shall perform and carry out all
`post-Registration activities) requested by the FDAJ connected with the
`NDA for the Products in the Field with the exception of those activities
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`4.6
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`specifically listed in the Fifth Appendix hereto, which shall be
`performed and carried out by HHC. Nothing in this Agreement precludes HHC
`from appointing an FDA Agent on different NDAs for products other than
`the Products (including, without limitation, any new dosage form(s)
`and/or formulation(s) of the Products in the Field under the terms
`provided at Article 2.6 hereabove) or for the Products outside the Field
`or from changing HHC's corporate agent in the United States ("U.S.
`Agent") at any time.
`
`All said activities, communications and relations as well as MGI's role
`of HHC's FDA Agent as described above shall be performed by MGI in close
`coordination with HHC, directly or through third parties, as the holder
`of the Registrations. In particular, MGI shall copy within 48 hours and
`keep HHC fully and promptly informed, throughout the term of this
`Agreement, of all communications received from the Regulatory Authorities
`of the Territory concerning the Products and/or the Compound. Without
`prejudice to full compliance by both Parties with any obligations
`established by applicable laws and regulations of the Territory with
`regard to adverse events reporting and any other deadlines set by
`Regulatory Authorities, any and all communications to Regulatory
`Authorities relevant to the Compound and/or the Products and connected
`with the activities described above, shall be sent by MGI only after the
`relevant contents have been discussed with and approved in writing by
`HHC, which approval shall be deemed to have been given if HHC does not
`otherwise respond within ten working days in Switzerland of receipt of
`such proposed communication; provided however, that MGI shall not be
`required to obtain such prior approval with respect to those mutually
`a