1/28/2016
`
`https://www .sec.gov/ Archives/edgar/data/702131/0001 04596901500128/dex992.txt
`
`<DOCUMENT>
`<TYPE>EX-99.2
`<SEQUENCE>3
`<FILENAME>dex992.txt
`<DESCRIPTION>SUPPLY AND PURCHASE AGREEMENT DATED APRIL 6J 2001
`<TEXT>
`
`<PAGE>
`
`Exhibit 99.2
`
`Supply and Purchase Agreement
`
`between
`
`HELSINN BIREX PHARMACEUTICALS LTD
`
`and
`
`MGI PharmaJ INC.
`
`DEFINITIONS
`PURCHASE OF PRODUCTS
`PRICE AND TERMS OF PAYMENT
`FORECASTS) ORDERS AND TERMS OF DELIVERY
`
`QUALITY
`RECORDS AND REPORTS
`REPRESENTATIONS AND WARRANTIES
`LIABILITIES) INDEMNITIES AND INSURANCE
`
`CONFIDENTIALITY
`FORCE MAJEURE
`TERM
`TERMINATION
`MISCELLANEOUS
`APPENDICES
`LAW TO GOVERN AND ARBITRATION
`ENTIRETY OF AGREEMENT AND SEVERABILITY
`
`Page 3
`Page 4
`Page 6
`Page 7
`Page 7
`
`Page 9
`Page 11
`Page 12
`Page 14
`
`Page 18
`Page 20
`Page 20
`Page 21
`Page 22
`Page 25
`Page 25
`Page 17
`
`<PAGE>
`
`TABLE OF CONTENTS
`
`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
`ARTICLE 14
`ARTICLE 15
`ARTICLE 16
`
`FIRST APPENDIX
`SECOND APPENDIX
`
`PRODUCTS
`PRICE
`
`https://www.sec.gov/Archives/edgar/data/702131/000104596901500128/dex992.txt
`
`Page 28
`Dr. Reddy’s Laboratories, Ltd., et al.
`Page 29
`v.
`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 1042
`
`1/20
`
`

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`1/28/2016
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`https://www .sec.gov/ Archives/edgar/data/702131/0001 04596901500128/dex992.txt
`
`<DOCUMENT>
`<TYPE>EX-99.2
`<SEQUENCE>3
`<FILENAME>dex992.txt
`<DESCRIPTION>SUPPLY AND PURCHASE AGREEMENT DATED APRIL 6J 2001
`<TEXT>
`
`<PAGE>
`
`Exhibit 99.2
`
`Supply and Purchase Agreement
`
`between
`
`HELSINN BIREX PHARMACEUTICALS LTD
`
`and
`
`MGI PharmaJ INC.
`
`DEFINITIONS
`PURCHASE OF PRODUCTS
`PRICE AND TERMS OF PAYMENT
`FORECASTS) ORDERS AND TERMS OF DELIVERY
`
`QUALITY
`RECORDS AND REPORTS
`REPRESENTATIONS AND WARRANTIES
`LIABILITIES) INDEMNITIES AND INSURANCE
`
`CONFIDENTIALITY
`FORCE MAJEURE
`TERM
`TERMINATION
`MISCELLANEOUS
`APPENDICES
`LAW TO GOVERN AND ARBITRATION
`ENTIRETY OF AGREEMENT AND SEVERABILITY
`
`<PAGE>
`
`TABLE OF CONTENTS
`
`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
`ARTICLE 14
`ARTICLE 15
`ARTICLE 16
`
`FIRST APPENDIX
`SECOND APPENDIX
`
`PRODUCTS
`PRICE
`
`Page 3
`Page 4
`Page 6
`Page 7
`Page 7
`
`Page 9
`Page 11
`Page 12
`Page 14
`
`Page 18
`Page 20
`Page 20
`Page 21
`Page 22
`Page 25
`Page 25
`Page 17
`
`Page 28
`Page 29
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`<PAGE>
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`-2-
`
`THIS AGREEMENT (hereinafter called "Agreement") is effective as of this 6th day
`of April 2BB1 (hereinafter called "Effective Date")) between HELSINN BIREX
`PHARMACEUTICALS LTDJ a corporation organized and existing under the law of the
`Republic of Ireland and having its registered office at DamastownJ MulhuddartJ
`Dublin 15) Republic of Ireland (hereinafter called "HBP") of the one part) and
`MGI PHARMAJ INC.J a corporation organized and existing under the law of the
`state of Minnesota) United States of America and having its registered office at
`63BB West Old Shakopee Road) Suite 11BJ Bloomington) MN 55438-2318) USA
`(hereinafter called "MGI")J of the other part.
`
`RECITALS
`
`a.
`
`b.
`
`c.
`
`MGI carries on business as a pharmaceutical company and) in particular
`for the purpose of this Agreement) has entered into a License Agreement
`(as hereinafter defined) with Helsinn Healthcare SAJ Via Pian ScairoloJ
`6912) PazzalloJ Switzerland (hereinafter called "HHC") by means of which
`MGI has been licensed with the right to distribute) promote) market and
`sell the Products (as hereinafter defined) in the Territory and has
`undertaken to purchase the Products exclusively from a source indicated
`or approved in writing by HHC.
`
`HBP carries on business as a pharmaceutical manufacturer and trader and)
`in particular for the purpose of this Agreement) represents that it has
`been duly appointed by HHC as the supplier of the Products to MGI for the
`purpose of the sale of said Products by MGI.
`
`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.
`
`NOWJ THEREFORE) in consideration of the foregoing and of the mutual covenants
`and conditions herein contained) the Parties hereby agree as follows:
`
`<PAGE>
`
`ARTICLE 1 - DEFINITIONS
`
`-3-
`
`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) 3Bth June) 3Bth
`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) by contract or otherwise.
`
`"Compound" means the active pharmaceutical ingredient
`1.3
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`(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.
`
`1.4
`
`1.5
`
`1.6
`
`"FDA" means the U.S. Food and Drug Administration or any successor
`agency.
`
`"License Agreement" means the license agreement entered into between MGI
`and HHC on April 6th, 2001 granting MGI the exclusive right to
`distribute, market and sell the Products in the Territory.
`
`"Net Sale Price" means the gross sale price in local currencies of the
`Products 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>
`
`1.7
`
`-4-
`
`"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>
`
`-5-
`
`1.8
`
`"Parties" means HBP and MGI and "Party" means either of them as the
`context indicates.
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`
`1.9
`
`1.10
`
`1.11
`
`1.12
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`
`"Products" means the pharmaceutical preparations for human use in I.V.
`dosage formJ containing the Compound as an active ingredient) in the
`formulation which will be described in the Registration. The current
`formulation as submitted to the Food and Drug Administration of the
`United States of America in the IND 39)797 Amendment# 64 and to the
`Therapeutic Products Programme of Canada in the IND 9427-H0836-21C is
`described in the First Appendix hereto.
`
`"Registration" means any official approval) or authorization by the
`competent regulatory authorities) 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.
`
`"Syntex Agreement" means a license agreement between HHC and Syntex
`(U.S.A.) LLC dated 23rd June 1998 by means of which HHC in-licensed
`world-wide rights on the Compound and Products.
`
`"Territory" means the United States of America and its possessions and
`territories (Puerto RicoJ United States Virgin Islands)) and Canada and
`its provinces) possessions and territories.
`
`ARTICLE 2 - PURCHASE OF PRODUCTS
`
`2.1
`
`2.2
`
`<PAGE>
`
`Throughout the term of this Agreement) and subject to the terms and
`conditions contained herein) MGI undertakes to purchase exclusively from
`HBPJ and HBP undertakes to sell to MGIJ MGI's entire requirements of the
`Products to be distributed) promoted) marketed and sold by MGI or MGI's
`Affiliates under the License Agreement.
`
`MGI shall not use the Products for any other purpose than distributing)
`promoting) marketing and selling said Products in accordance with the
`terms and conditions of the License Agreement.
`
`-6-
`
`ARTICLE 3 - PRICE AND TERMS OF PAYMENT
`
`3.1
`
`3.2
`
`The price of the Products purchased by MGI hereunder is as set forth in
`the Second Appendix hereto. ***
`Any payment by MGI for the delivered Products shall be effected by wire
`transfer of immediately available funds to an account designated in
`writing by HBP in United States Dollars within 30 (thirty) days from the
`date of receipt of the invoice (which shall be deemed to have been
`received on the date following the date of delivery to MGI by telefax)
`and be deemed paid when freely received. MGI shall bear all costs in
`connection with effecting payments.
`
`3.3
`
`3.4
`
`MGI shall in no case be entitled to off set or otherwise withhold any
`payment due to HBP in view of possible) justified or unjustified) claims
`against HBP.
`***
`
`ARTICLE 4 - FORECASTS) ORDERS AND TERMS OF DELIVERY
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`4.1
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`MGI shall, prior to September 30th in each year throughout the term of
`this Agreement, supply HBP in writing with a purchase forecast for the
`Products for each Accounting Period of the following calendar year. Any
`such forecast shall be deemed to be a binding order by MGI for the first
`Accounting Period
`
`*** 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>
`
`-7-
`
`of such year. Moreover MGI shall issue its firm orders relevant to the
`three following Accounting Periods at least 90 (ninety) days in advance
`of the requested delivery date and, at each time, it shall supply HBP
`with its purchase forecast relevant to a further calendar year so as to
`maintain at all times a rolling twelve-month purchase forecast and shall
`promptly notify HBP of any projected changes thereto.
`
`4.2
`
`The Products will be supplied to MGI only against MGI's written order and
`all orders shall be subject to written acceptance and confirmation by HBP
`before becoming binding. Such acceptance and confirmation may be by
`facsimile or otherwise. Each order by MGI shall be for a minimum quantity
`corresponding to the size of one production batch of Products, as shall
`be indicated in due time by HBP, or multiples thereof.
`
`HBP shall use commercially reasonable efforts to execute all orders
`received and accepted pursuant to this Article within 90 (ninety) days
`from the date of receipt of the relevant order by HBP. MGI's firm orders
`shall be at least *** and not more than *** of its forecast of Products
`for the applicable Accounting Period as per Article 4.1 hereabove. HBP
`shall not be obliged to supply more than *** of MGI's initial forecast of
`Products within the applicable Accounting Period. However, in the event
`that, in any Accounting Period, MGI's orders are more than *** of the
`relevant forecasts, HBP agrees to use commercially reasonable efforts to
`supply MGI with amounts in excess of MGI's forecast of Product during
`said Accounting Period, on condition however that this shall not hamper,
`delay or otherwise prejudice supplies of Products to any other of HBP's
`customers. MGI shall keep throughout the term of this Agreement a stock
`of Products adequate to meet market demand and to cover possible
`shortages in the supplies of Products, such stock to approximately
`correspond at least to three-month average sales. In turn, HBP undertakes
`to keep throughout the term of this Agreement a stock of Products in
`semi-finished form (i.e. vials without final packaging) approximately
`corresponding to at least to two-month average sales.
`
`4.3
`
`Any purchase order or acknowledgement thereof, whether printed, stamped,
`typed or written, shall be governed by the terms and conditions of this
`Agreement and none of the provisions of such purchase order or
`acknowledgement thereof shall be applicable, except those specifying
`quantity
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`
`*** 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>
`
`4.4
`
`4.5
`
`-8-
`
`ordered, delivery dates and invoice information, and with respect to
`those specifications only to the extent that they are in compliance with
`the terms and conditions of this Agreement. To the extent there is any
`discrepancy between this Agreement and any purchase order or
`acknowledgement thereof, this Agreement will control.
`
`All orders of Products shall be delivered DDU (Incoterms 2000) MGI's or
`MGI nominee's warehouse in the United States of America, unless otherwise
`agreed in writing by the Parties. MGI shall be solely responsible for all
`customs clearance of, and import/export regulations for, the Products and
`it shall bear and pay all taxes, duties, levies and other charges imposed
`by reason of its purchase, import and resale of the Products.
`
`If, for any reason, HBP is unable to supply MGI's firm orders for the
`Products up to the forecasted level, or is unable to supply such
`quantities in a manner meeting the Specifications, during any ninety (90)
`day period, the Parties shall promptly meet to discuss the reasons for
`such failure to supply, and HBP shall thereafter designate a third party
`manufacturer to manufacture the Products. HBP shall provide to such third
`party manufacturer, appropriate manufacturing licenses and reasonable
`technical assistance to enable it to manufacture the Products, in a
`manner that minimizes disruption to MGI of Product supply.
`
`ARTICLE 5 - QUALITY
`
`5.1
`
`5.2
`
`HBP shall manufacture, or shall cause the Products to be manufactured, in
`accordance with applicable current Good Manufacturing Practice and with
`applicable specifications.
`
`Each batch of Products shall be delivered to MGI accompanied by
`appropriate certificates of analysis, attesting the compliance of each
`relevant batch with the specifications for said Products as the same are
`contained in the Registration of the Products. MGI shall carry out
`appropriate visual inspection of the Products, as well as any other
`analysis which MGI may deem appropriate or necessary, upon receipt.
`Should it occur that any batch of Products does not meet said approved
`specifications, MGI shall, as soon as possible and in any case within 30
`(thirty) days after receipt of the Products, give notice in writing to
`HBP specifying in detail the claimed non-conforming characteristics of
`the Products.
`
`<PAGE>
`
`-9-
`
`In the absence of MGI's notification within the said term, MGI shall be
`deemed to have accepted such Products. Should HBP recognize that such
`Products delivered to MGI do not meet the approved specifications, and
`provided MGI demonstrates that the Products have been properly handled
`and stored after delivery, HBP shall replace, at its own cost, such
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`5.3
`
`5.4
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`Products. Such replacement shall be done, to the extent possible, in
`accordance with the timing reasonably agreed among the Parties which, in
`any event, shall be as soon as reasonably possible thereafter. It is
`understood and agreed that HBP's total responsibilities hereunder shall
`be limited to said replacement of Products. Should HBP not be in
`agreement with MGI's claim of defect, a sample of the alleged defective
`Products shall be submitted for analysis to an independent laboratory to
`be agreed in good faith between MGI and HBP in writing. The decision of
`such laboratory shall be final and binding for both MGI and HBP and the
`corresponding expenses will be paid by the Party found to be in error.
`
`HBP shall at any time be free to determine the manufacturer and the place
`of manufacture of the Products, subject however to applicable laws and
`regulations and to compliance with the License Agreement. In no event
`shall MGI be entitled to manufacture any Products by virtue of this
`Agreement.
`
`MGI shall store and distribute, and shall cause the Products to be stored
`and distributed, according to applicable current Good Manufacturing
`Practice or any other applicable laws and regulations. MGI shall permit
`HBP's representatives) during normal business hours and upon three
`business days advance notice in writing but not more than once a year or
`as otherwise reasonably requested by HBP, to inspect those areas of the
`warehouses of MGI, its Affiliates and its distributors where the Products
`are inspected, analyzed or stored, for the purpose of verifying
`compliance with applicable laws and regulations as well as with this
`Agreement. Such inspection shall include, without limitation, the right
`to examine any relevant internal procedures or records of MGI, its
`Affiliates and distributors. MGI shall give and shall cause its
`Affiliates and distributors to give, all necessary assistance for a full
`and correct carrying out of the inspection by HBP. No such inspection by
`HBP shall relieve MGI, its Affiliates and distributors of any of their
`obligations under this Agreement in any way whatsoever.
`
`5.5
`
`The Products shall be supplied by HBP or HBP's nominee to MGI in a
`secondary package inclusive of leaflet, ready for distribution. Artwork
`and all necessary films for printing packsJ package inserts, leaflets and
`labels will be
`
`<PAGE>
`
`-10-
`
`prepared and supplied by MGI, at its expenses, based upon indications,
`box design and measurements provided by HBP. Any change shall have to be
`communicated by MGI to HBP at least 6 (six) months in advance of its
`enforcement. The costs relevant to the change, including costs relevant
`to repackaging or disposal of Products in stock at HBP, (i) shall be
`entirely borne by MGI if the change has been requested by MGI, and (ii)
`shall be shared between the parties in case the change is required by any
`regulatory authority or is jointly deemed advisable by the Parties.
`
`5.6
`
`Events concerning Product recall, complaint) field alert or Product
`withdrawal relevant to the Products marketed by MGI in the Territory
`shall be governed by the procedures and rules established in the Licence
`Agreement.
`
`ARTICLE 6 - RECORDS AND REPORTS
`
`6.1
`
`MGI shall submit to HBP at the end of each Accounting Period a written
`statement signed by a responsible officer of MGI which shall show the
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`units of Products sold or otherwise disposed of by MGIJ the gross sale
`price and the Net Sale Price of the Products and any change thereof,
`together with a detailed listing and appropriate evidence of any and all
`discounts granted for each clientJ wholesaler and/or distributor as
`necessary to permit to HBP to calculate and verify the supply price of
`the Products as per the Second Appendix heretoJ the gross sales and the
`Net Sales for said Accounting Period and the existing stock of Products
`in MGI'sJ its Affiliates' and its distributors' warehouses. Throughout
`the term of this Agreement and for a period of at least 3 (three) years
`thereafter) MGI shall keep complete and accurate booksJ records and
`accounts in accordance with sound accounting practice covering all its
`operations hereunder as necessary to determine and verify the units of
`Products sold or otherwise disposed of by MGIJ the Net Sale Price of the
`Products) the Net Sales for each Accounting PeriodJ and any change
`thereof. HBP shall have the rightJ at any time throughout the term of
`this Agreement and for a period of three years thereafter) during normal
`business hours and upon at least three (3) business days advance noticeJ
`to have such booksJ records and accounts inspected and audited by its
`duly authorized representatives orJ at HBP's discretion) by an
`independent certified public accountant to be nominated by HBP and
`reasonably acceptable to MGI. MGI shall fully co-operate with HBPJ its
`authorized representatives or independent certified public accountant and
`make available all work papers and other information reasonably requested
`in
`
`<PAGE>
`
`-11-
`
`connection herewith. In the event the inspection or audit reveals that an
`underpayment has occurred) MGI shall immediately pay to HBP any underpaid
`amount within 10 (ten) days of the date HBP delivers to MGI the relevant
`inspection or audit report. In case of an underpayment of at least five
`percent (5%) of the amounts owing during the audited period, MGI shall
`also bear all the costs of the inspection or audit and any overdue
`amounts hereunder shall bear interest at the prime rate applicable in
`Switzerland as of the date such payment was originally due.
`
`6.2
`
`Each of the Parties hereby agrees that any and all communications sent to
`or received from the other Party hereunder) including but not limited to
`those described at Article 13.2 hereunder) shall be immediately sent in
`copy by telefax to HHC.
`
`ARTICLE 7 - REPRESENTATIONS AND WARRANTIES
`
`7.1
`
`HBP hereby represents and warrants to MGI as follows:
`
`7.1.1 HBP has been duly organized and is validly existing as a
`corporation in good standing under the laws of the Republic of
`Ireland. HBP has the corporate power and authority to enter into
`this Agreement and to consummate the transactions contemplated by
`this Agreement.
`7.1.2 The execution, delivery and performance of this Agreement) and the
`consummation of the transactions contemplated by this Agreement)
`by HBP have been duly and validly authorized by all requisite
`corporate actions. This Agreement constitutes a legalJ valid and
`binding agreement of HBP enforceable against HBP in accordance
`with its terms.
`7.1.3 The execution, delivery and performance by HBP of this Agreement
`requires no action by or in respect ofJ or consent or approval ofJ
`or filing withJ any Governmental Authority.
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`7.1.4. The execution, delivery and performance by HBP of the contemplated
`transactions do not and will not (A) contravene or conflict with
`the charter or bylaws of HBP, as applicable, (B) contravene or
`conflict with or constitute a violation of any provisions of any
`applicable law binding upon HBP, or (C) constitute a default in
`any material respect under or give rise to any right of
`termination, cancellation or acceleration of, any
`
`<PAGE>
`
`-12-
`
`agreement or instrument to which HBP is a party, or to a loss of
`any material benefit to which HBP is entitled.
`7.1.5. There is no action, suit, investigation or proceeding pending
`against, or to the knowledge of HBP, threatened against or
`affecting, HBP before any court, arbitrator or any governmental
`authority, including but not limited to Regulatory Authorities,
`that in any manner challenges or seeks to prevent, enjoin, alter
`or materially delay the contemplated transactions, and, to the
`knowledge of HBP, there is no reasonably valid basis for any such
`action, suit, investigation or proceeding to be brought.
`7.1.6 The persons executing this Agreement on behalf of HBP are duly
`authorized to do so and by so doing have bound HBP to the terms
`and conditions of this Agreement.
`7.1.7 HBP has been duly authorized and entrusted by HHC to supply the
`Products to MGI.
`
`7.2
`
`MGI hereby represents and warrants to HBP as follows:
`
`7.2.1 MGI is a corporation duly incorporated, validly existing and in
`good standing under the laws of the state of its incorporation and
`has all corporate powers and all governmental licenses,
`authorizations, consents and approvals required to carry on its
`business as now conducted and as contemplated to be conducted in
`connection with the transactions contemplated by this Agreement
`(the "Contemplated Transactions"). MGI is duly qualified to do
`business as a foreign corporation in each jurisdiction where the
`character of the property owned or leased by it or the nature of
`its activities (after giving effect to the Contemplated
`Transactions) make such qualification necessary to carry on its
`business, except where the failure to so qualify would not have a
`material adverse effect on MGI.
`7.2.2 The execution, delivery and performance by MGI of this Agreement
`and the consummation by MGI of the Contemplated Transactions are
`within the corporate powers of MGI, and have been duly authorized
`by all necessary corporate action on the part of MGI. This
`Agreement constitutes a legal, valid and binding agreement of MGI,
`enforceable against MGI as applicable in accordance with its
`terms.
`7.2.3 The execution, delivery and performance by MGI of this Agreement
`requires no action by or in respect of, or consent or approval of,
`or filing with, any Governmental Authority, other than filings
`with the
`
`<PAGE>
`
`-13-
`
`SEC in fulfillment of MGr•s disclosure obligations under u.s.
`securities laws.
`7.2.4 The execution, delivery and performance by MGI of the Contemplated
`Transactions do not and will not (A) contravene or conflict with
`https://www.sec.gov/Archives/edgar/dataf702131/000104596901500128/dex992.txt
`
`9/20
`
`Exh. 1042
`
`

`
`1/28/2016
`
`https://www .sec.gov/Archives/edgar/data/702131 /0001 04596901500128/dex992.txt
`the charter or bylaws of MGI~ as applicable~ (B) contravene or
`conflict with or constitute a violation of any provisions of any
`Applicable Law binding upon MGI~ or (C) constitute a default in
`any material respect under or give rise to any right of
`termination~ cancellation or acceleration of~ any agreement or
`instrument to which MGI is a party~ or to a loss of any material
`benefit to which MGI is entitled.
`7.2.5 There is no action~ suit~ investigation or proceeding pending
`against~ or to the knowledge of MGI~ threatened against or
`affecting~ MGI before any court~ arbitrator or any governmental
`authority~ including but not limited to regulatory authorities~
`that in any manner challenges or seeks to prevent~ enjoin~ alter
`or materially delay the Contemplated Transactions~ and~ to the
`knowledge of MGI~ there is no reasonably valid basis for any such
`action~ suit investigation or proceeding to be brought.
`7.2.3 The persons executing this Agreement on behalf of MGI are duly
`authorized to do so and by so doing have bound MGI to the terms
`and conditions of this Agreement.
`
`ARTICLE 8 - LIABILITIES~ INDEMNITIES AND INSURANCE
`
`8.1
`
`MGI shall be fully liable for and shall defend~ indemnify and hold HBP
`and its Affiliates~ officers~ directors and employees wholly free and
`harmless from and against any and all liabilities) damages~ losses~
`costsJ taxes, expenses (including reasonable attorneys' fees and other
`expenses of litigation and arbitration), claims~ demands~ suits~
`penalties, judgements or administrative and judicial orders arising out
`of or resulting from any claim~ suit or proceeding to the extent arising
`out of or resulting from (a) any failure by MGI, its local distributors
`or Affiliates to comply with any applicable lawsJ regulations and/or
`administrative decision regarding the Products; (b) the storage,
`distribution, sampling~ record-keepingJ analysis~ transfer or sale of the
`Products; (c) the promotion) advertising and marketing of the Products;
`(d) the failure of any Products supplied hereunder to comply with the
`applicable approved specifications that (i) could have been detected by
`MGI carrying out visual inspection on the supplied Products with ordinary
`diligence or (ii) results from
`
`<PAGE>
`
`-14-
`
`any Products which have been altered, changed~ packed or re-packed,
`processed or otherwise treated other than in strict accordance with HBP's
`instructions and specifications; or (e) any negligent or wrongful act or
`omission and/or any breach by MGI or by any of its local distributors
`and/or Affiliates of any of MGI's obligations~ representations and/or
`warranties hereunder.
`
`8.2
`
`HBP shall be liable for and shall defend~ indemnify and hold MGI and its
`Affiliates~ officers~ directors and employees free and harmless from and
`against any and all liabilities~ damages~ losses~ costs~ expenses
`(including reasonable attorneys' fees and other expenses of litigation
`and arbitration), claims, demandsJ suits~ penalties~ judgments or
`administrative and judicial orders~ arising out of or in any way
`resulting from any claim~ suit or proceeding to the extent arising out of
`or resulting from (a) failure of any Products supplied hereunder to
`conform to the applicable approved specifications) excluding however any
`liabilities) losses, damagesJ costs~ expenses claims, demandsJ suitsJ
`penalties, judgments or orders resulting from any such non-compliance
`that (i) could have been detected by MGI carrying out visual inspections
`https://www.sec.gov/Archives/edgar/data/702131/000104596901500128/dex992.txt
`
`10/20
`
`Exh. 1042
`
`

`
`1/28/2016
`
`8.3
`
`https://www.sec.gov/Archives/edgar/data/702131/000104596901500128/dex992.txt
`on the supplied Products with ordinary diligence or (ii) results from any
`Products which have been altered, changed, packed or re-packed, processed
`or otherwise treated other than in strict accordance with HBP's
`instructions and specificationsj or (b) any negligent or wrongful act or
`omission and/or breach by HBP of any of its obligations and/or warranties
`hereunder.
`
`Being understood that each of the Parties hereto shall take all
`reasonable steps to avoid or mitigate any loss, damage or liability which
`might give rise to a claim under this Agreement, a Party seeking
`indemnification pursuant to this Article 8 (an "Indemnified Party") shall
`give prompt and full written notice to the Party from whom such
`indemnification is sought (the "Indemnifying Party") of the assertion of
`any claim, or the commencement of any action, suit or proceeding in
`respect of which indemnity is or may be sought hereunder, provided
`however that no failure to give such notice or co-operation shall relieve
`the Indemnifying Party of any liability and/or obligation hereunder
`(except to the extent the Indemnifying Party has suffered actual
`prejudice thereby). Subject to any right of Syntex (U.S.A.) LLC under the
`Syntex Agreement, the Indemnifying Party shall have the sole right to
`control the defense and settlement thereof. The Indemnified Party will
`give the Indemnifying Party such information with respect thereto as the
`Indemnif