Exhibit 99.2
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Supply and Purchase Agreement
between
HELSINN BIREX PHARMACEUTICALS LTD
and
MGI Pharma, INC.
TABLE OF CONTENTS
RECITALS Page 3
ARTICLE 1 DEFINITIONS Page 4
ARTICLE 2 PURCHASE OF PRODUCTS Page 6
ARTICLE 3 PRICE AND TERMS OF PAYMENT Page 7
ARTICLE 4 FORECASTS, ORDERS AND TERMS OF DELIVERY Page 7
ARTICLE 5 QUALITY Page 9
ARTICLE 6 RECORDS AND REPORTS Page 11
ARTICLE 7 REPRESENTATIONS AND WARRANTIES Page 12
ARTICLE 8 LIABILITIES, INDEMNITIES AND INSURANCE Page 14
ARTICLE 9 CONFIDENTIALITY Page 18
ARTICLE 10 FORCE MAJEURE Page 20
ARTICLE 11 TERM Page 20
ARTICLE 12 TERMINATION Page 21
ARTICLE 13 MISCELLANEOUS Page 22
ARTICLE 14 APPENDICES Page 25
ARTICLE 15 LAW TO GOVERN AND ARBITRATION Page 25
ARTICLE 16 ENTIRETY OF AGREEMENT AND SEVERABILITY Page 17
FIRST APPENDIX PRODUCTS Page 00
XXXXXX XXXXXXXX PRICE Page 29
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THIS AGREEMENT (hereinafter called "Agreement") is effective as of this 6th day
of April 2001 (hereinafter called "Effective Date"), between HELSINN BIREX
PHARMACEUTICALS LTD, a corporation organized and existing under the law of the
Republic of Ireland and having its registered office at Damastown, Mulhuddart,
Xxxxxx 00, Xxxxxxxx of Ireland (hereinafter called "HBP") 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
0000 Xxxx Xxx Xxxxxxxx Xxxx, Xxxxx 000, Xxxxxxxxxxx, XX 00000-0000, XXX
(hereinafter called "MGI"), of the other part.
RECITALS
a. 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 SA, Xxx Xxxx Xxxxxxxx,
0000, Xxxxxxxx, Xxxxxxxxxxx (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.
b. 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.
c. 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:
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ARTICLE 1 - DEFINITIONS
The following terms as used in this Agreement have, unless the context clearly
indicates otherwise, the following meanings:
1.1 "Accounting Period" means the quarters ending 31st March, 30th June, 30th
September and 31st December in each year throughout the term of this
Agreement.
1.2 "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.
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.
1.4 "FDA" means the U.S. Food and Drug Administration or any successor
agency.
1.5 "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.
1.6 "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. ***
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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.
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1.7 "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. ***
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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.
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1.8 "Parties" means HBP and MGI and "Party" means either of them as the
context indicates.
1.9 "Products" means the pharmaceutical preparations for human use in I.V.
dosage form, 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.
1.10 "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.
1.11 "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.
1.12 "Territory" means the United States of America and its possessions and
territories (Puerto Rico, United States Virgin Islands), and Canada and
its provinces, possessions and territories.
ARTICLE 2 - PURCHASE OF PRODUCTS
2.1 Throughout the term of this Agreement, and subject to the terms and
conditions contained herein, MGI undertakes to purchase exclusively from
HBP, and HBP undertakes to sell to MGI, MGI's entire requirements of the
Products to be distributed, promoted, marketed and sold by MGI or MGI's
Affiliates under the License Agreement.
2.2 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.
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ARTICLE 3 - PRICE AND TERMS OF PAYMENT
3.1 The price of the Products purchased by MGI hereunder is as set forth in
the Second Appendix hereto. ***
3.2 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 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.
3.4 ***
ARTICLE 4 - FORECASTS, ORDERS AND TERMS OF DELIVERY
4.1 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
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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.
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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.
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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.
4.4 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.
4.5 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 HBP shall manufacture, or shall cause the Products to be manufactured, in
accordance with applicable current Good Manufacturing Practice and with
applicable specifications.
5.2 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.
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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
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.
5.3 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.
5.4 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 packs, package inserts, leaflets and
labels will be
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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
units of Products sold or otherwise disposed of by MGI, 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 client, 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 hereto, the gross sales and the
Net Sales for said Accounting Period and the existing stock of Products
in MGI's, 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 books, 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 MGI, the Net Sale Price of the
Products, the Net Sales for each Accounting Period, and any change
thereof. HBP shall have the right, 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 notice,
to have such books, records and accounts inspected and audited by its
duly authorized representatives or, 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 HBP, its
authorized representatives or independent certified public accountant and
make available all work papers and other information reasonably requested
in
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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 legal, 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 of, or consent or approval of,
or filing with, any Governmental Authority.
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
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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
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SEC in fulfillment of MGI'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
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,
costs, 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 laws, regulations and/or
administrative decision regarding the Products; (b) the storage,
distribution, sampling, record-keeping, 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
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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, demands, 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, damages, costs, expenses claims, demands, suits,
penalties, judgments or orders resulting from any such non-compliance
that (i) could have been detected by MGI carrying out visual inspections
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 specifications; or (b) any negligent or wrongful act or
omission and/or breach by HBP of any of its obligations and/or warranties
hereunder.
8.3 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
Indemnifying Party may reasonably request and will co-operate with the
Indemnifying Party in the defense of said claim, suit or proceeding as
the Indemnifying Party may
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reasonably request. The Indemnified Party shall not, except at its own
cost, voluntarily make any payment or incur any expense with respect to
any claim, suit or proceeding without the prior written consent of the
Indemnifying Party. In addition, the Indemnifying Party shall be
subrogated to the rights of the Indemnified Party against any third
party, and such Indemnified Party hereby assigns to the Indemnifying
Party all claims, causes of action and other rights which the Indemnified
Party may then have against any third party, including Affiliates and, in
the case of HBP, against any contract manufacturer of the Products, with
respect to the claim, suit or proceeding which is the subject of the
claim for indemnification hereunder. Conversely, and without in any way
limiting the obligation of either Party to indemnify the other Party as
herein provided, to the extent that either Party shall fail to perform
its indemnification obligations under this Article 8, such Party owing a
duty of indemnification hereby assigns to the other Party all claims,
cause of action and other rights which the Party owing such duty may then
have against any third party, including Affiliates and, in the case of
HBP, against any contract manufacturer of the Products, with respect to
the claim, suit or proceeding.
8.4 MGI shall be solely responsible towards its customers for handling all
matters concerning the Products, subject to cooperation with HBP on any
recall or other matters that may be injurious to HBP. MGI shall be
responsible for any expired Products, whether stored by MGI and/or its
local distributors or returned by wholesalers, pharmacists, doctors,
hospitals to whom said Products have been sold. HBP shall (i) reimburse
to MGI documented reasonable costs incurred by MGI with regard to the
destruction of expired Products, up to a maximum quantity of *** of the
units of Products sold by MGI in any calendar year and (ii) replace free
of charge said expired Products, up to a maximum quantity of *** of the
units of Products sold by MGI in any calendar year. Except as provided
hereabove, MGI shall not be entitled to any replacement of Products nor
to any compensation of any kind from HBP in connection herewith. MGI
shall indemnify, defend and hold HBP and its Affiliates, directors,
officers and employees wholly 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, demands, suits, penalties, judgments or administrative and
judicial orders arising therefrom; except with respect to any recall or
other regulatory action arising from any breach by HBP or its Affiliates
of any warranty, representation or other material obligation contained in
this Agreement or the negligence or willful misconduct. of HBP or its
Affiliates.
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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.
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8.5 Each Party shall indemnify and hold the other Party wholly harmless from
and against any and all liabilities, damages, losses, costs, expenses
(including reasonable attorneys' fees and other expenses of litigation
and arbitration), claims, demands, suits, penalties, judgments or
administrative and judicial orders arising out of any behavior contrary
or in excess to the provisions of Article 13.1 hereunder.
8.6 THE SOLE REPRESENTATIONS AND WARRANTIES THAT HBP MAKES WITH RESPECT TO
THE MATTER CONTEMPLATED BY THIS AGREEMENT ARE EXPRESSLY SET FORTH IN
ARTICLE 7.1. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, HBP MAKES
NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, OF
MARKETABILITY, CAPACITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT
TO THE PRODUCTS. NO ORAL OR WRITTEN REPRESENTATION BY OR ON BEHALF OF HBP
SHALL BE INTERPRETED TO CONTAIN ANY SUCH WARRANTY. NEITHER MGI NOR ANY OF
ITS EMPLOYEES OR REPRESENTATIVES IS AUTHORISED TO GIVE ANY WARRANTIES OR
MAKE ANY REPRESENTATION ON BEHALF OF HBP.
8.7 THE SOLE REPRESENTATIONS AND WARRANTIES THAT MGI MAKES WITH RESPECT TO
THE MATTER CONTEMPLATED BY THIS AGREEMENT ARE EXPRESSLY SET FORTH IN
ARTICLE 7.2. AND MGI HEREBY DISCLAIMS ALL OTHER REPRESENTATIONS OR
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. NO ORAL OR WRITTEN
REPRESENTATION BY OR ON BEHALF OF MGI SHALL BE INTERPRETED TO CONTAIN ANY
SUCH WARRANTY. NEITHER HBP NOR ANY OF ITS EMPLOYEES OR REPRESENTATIVES IS
AUTHORISED TO GIVE ANY WARRANTIES OR MAKE ANY REPRESENTATION ON BEHALF OF
MGI.
8.8 NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, NEITHER OF THE
PARTIES SHALL BE LIABLE TOWARDS THE OTHER FOR INDIRECT, SPECIAL,
PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING
WITHOUT LIMITATION LOSS OF PROFITS OR REVENUES, REGARDLESS OF WHETHER
SUCH DAMAGES WERE FORESEEABLE OR NOT. THIS CLAUSE WILL HOWEVER NOT BE
APPLICABLE IN CASE OF BREACH BY MGI OF THE PURCHASE OBLIGATIONS STATED AT
ARTICLE 2 AND BREACH BY EITHER
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PARTY OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS STATED AT ARTICLE 9
OF THIS AGREEMENT.
8.9 Each Party agrees to procure and maintain in full force and effect during
the term of this Agreement valid and collectible insurance policies in
connection with its activities as contemplated herein. In particular, MGI
at its own cost shall cause HBP to be added as additional named insured
throughout the term of this Agreement on all policies of general
commercial liability insurance and product liability insurance covering
MGI, which coverage shall, when MGI either initiates clinical trials on
the Products or begins marketing or distributing the Products for
commercial sale or for promotional purposes, have limits of liability
which are commercially reasonable in the Territory but shall be not less
than USD *** per loss occurrence. Within 5 (five) days of the Effective
Date and of each beginning of each policy period, MGI shall provide HBP
with a certificate evidencing the coverage required hereby and the amount
thereof. Such coverage shall be with a reputable insurance company having
at least an A.M. Best "A" rating and shall have to be maintained for not
less than 6 (six) years following expiration or termination of this
Agreement for any reason or if such coverage is of the "claims made"
type, for ten years following expiration or termination of this Agreement
for any reason.
ARTICLE 9 - CONFIDENTIALITY
9.1 MGI shall treat as strictly confidential, and shall use solely for the
purpose of and in accordance with this Agreement, any and all
information, data and/or document received hereunder or in connection
with the Contemplated Transaction not generally known to the trade (all
hereinafter referred to as the "Confidential Information"). MGI shall not
make such Confidential Information available to any third Party,
including any of its Affiliates, except to competent government agencies
to which it will be necessary to disclose such Information, and in this
case (a) strictly to the extent requested by said agencies and (b) only
upon exercise of its best efforts to cause said agencies to maintain
confidentiality thereof.
9.2 Such Confidential Information shall only be made available to such
employees of MGI who are directly and necessarily involved in the
authorized use of Confidential Information and who are subject to a
secrecy obligation by
------------------
*** 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.
-18-
contract, to the extent strictly necessary to perform their duties and
obligations hereunder.
9.3 Notwithstanding expiration or termination of this Agreement for any
reason, these confidentiality and non-use obligations shall continue
until the Confidential Information has become generally known to the
public, provided however that nothing contained herein shall in any way
restrict or impair the right of MGI to use, disclose or otherwise deal
with Information which MGI can demonstrate to HBP by clearly convincing
documentation:
9.3.1 is or hereafter becomes part of the public domain through no act
or omission of MGI, its employees, Affiliates and/or local
distributors, or
9.3.2 MGI was in lawful possession of prior to receipt of the
Confidential Information from HBP, or
9.3.3 previously was, or at any time hereafter is, received in good
faith by MGI from sources other than HBP and/or HHC and which did
not originate, directly or indirectly, from Syntex, or
9.3.4 at the time of disclosure, was known by MGI or an Affiliate or
local distributor, or after disclosure was independently developed
by MGI, an Affiliate or local distributor without use of the
Confidential Information.
9.4 HBP shall keep strictly confidential, in the same way mutatis mutandis as
provided here above for MGI in respect of Confidential Information, any
MGI Confidential Information (as defined herein)received from MGI
hereunder, except as otherwise specifically provided in this Agreement.
As used herein, the term "Confidential Information" shall mean all
information disclosed by MGI to HBP, relating to the markets, customers,
suppliers, patents or patent applications, inventions, know-how, data or
information, products, research and development, procedures, designs,
formulas, business plans, financial projections, employees, consultants
or any other similar aspects MGI's present or future business, whether
such information is disclosed in written, oral, electronic, graphic or
other format.
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XXXXXXX 00 - XXXXX XXXXXXX
10.1 Except as set forth in Section 4.5, if the performance of this Agreement
is prevented or restricted by government action, war, fire, explosion,
flood, strike, lockout, embargo, act of God, or any other similar cause
beyond the control of the defaulting Party, the Party so affected shall
be released for the duration of the force majeure, or such other period
agreed between the Parties as being reasonable in all circumstances, from
its contractual obligations directly affected by the force majeure,
provided that the Party concerned shall:
10.1.1 give prompt notice in writing to the other Party of the cause of
force majeure;
10.1.2 use all best endeavors to avoid or remove such cause of
non-performance;
10.1.3 continue the full performance of this Agreement as soon as such
cause is removed.
10.2 The Parties shall take all reasonable steps to minimize the effects of
force majeure on the performance of this Agreement and shall, if
necessary, agree on appropriate measures to be taken. Should the force
majeure continue for more than 6 (six) months, then the other Party shall
have the right to terminate this Agreement forthwith.
10.3 Notwithstanding anything contained in this Article 10, obligations to pay
money accruing prior to the force majeure event are never excused by
force majeure.
ARTICLE 11 - TERM
11.1 This Agreement comes into force at the Effective Date hereof. Unless
terminated earlier pursuant to the provisions hereof, it shall terminate
automatically at termination or expiration for any reason of the License
Agreement.
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ARTICLE 12 - TERMINATION
12.1 Each of the Parties reserves the right to terminate this Agreement in
case of any substantial or persistent breach of any of the terms and
conditions of this Agreement by the other Party. The defaulting Party
shall be given in writing a 60 (sixty)-day period, except as otherwise
specifically provided, to fulfill its obligations hereunder and, if after
such period it is still in breach of the Agreement, the other Party shall
have the right to terminate this Agreement by written notice to the
defaulting Party. In the event of a breach by MGI of any of the terms and
conditions of this Agreement entitling HBP to terminate this Agreement
under this Article 12.1, HBP shall immediately and fully inform HHC in
writing for appropriate actions by HHC. In particular, MGI hereby
acknowledges and agrees that termination of this Agreement by HBP
pursuant to this Article 12.1 shall entitle HHC to terminate the License
Agreement.
12.2 Either Party shall have the right to terminate this Agreement upon
written notice to the other Party, if such other Party shall become
insolvent or shall make an assignment for the benefit of creditors or
become involved in receivership, bankruptcy or other insolvency or debtor
relief proceedings, or any similar proceedings, or in proceedings,
voluntary or forced, whereby the Party involved is limited in the free
and unrestrained exercise of its own judgment as to the carrying out of
the terms of this Agreement.
12.3 HBP shall have the right to terminate this Agreement by written notice to
MGI if MGI infringes the confidentiality and/or non-use obligations
provided for in Article 9 hereabove. MGI shall have the right to
terminate this agreement by written notice to HBP if HBP breaches the
confidentiality and/or non-use obligations provided for in Article 9.4
hereabove.
12.4 Without limiting the generality of the foregoing, termination or
expiration of this Agreement for any reason shall not extinguish any
existing claims either of the Parties may have for indemnification and
shall not preclude either of the Parties from pursuing any claim for
indemnification such Party otherwise may have to the extent that the
circumstances giving rise to such claim arose prior to, on or after the
date of termination or expiration.
12.5 Upon expiration or termination of this Agreement for any reason, MGI
shall promptly terminate using any and all information and data received
hereunder
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and return or deliver all such materials to HBP without retaining copies,
notes, summaries or translations thereof.
12.6 Unless otherwise set forth herein, the Parties' remedies under this
Agreement are intended to be cumulative and not mutually exclusive.
ARTICLE 13 - MISCELLANEOUS
13.1 Independent contractor status
The status of HBP and MGI under the business arrangement established by
this Agreement is that of independent contractors. MGI shall perform as
an independent contractor in relation to both HBP and MGI's customers
and, accordingly, MGI shall purchase the Products from HBP or HBP's
nominee and resell them to its customers in its own name and for its own
account. MGI has no authority whatsoever to act as an agent or
representative of HBP nor any authority or power to contract in the name
of or create any liability against or otherwise bind HBP in any way for
any purpose, nor shall HBP have such authority or power to so bind MGI.
13.2 Notices
All reports, notices and communications given or made pursuant to this
Agreement by one Party to the other shall be validly given or made for
all purposes, in the absence of acknowledgement of receipt, on the date
of mailing if mailed by registered airmail or by international courier to
the addressee Party at the following addresses, respectively:
HELSINN BIREX PHARMACEUTICALS LTD.
Damastown
Mulhuddart
Xxxxxx 00
Republic of Ireland
For the attention of: General Manager
With copy to:
HELSINN HEALTHCARE SA
X.X. XXX 000
0000 Xxxxxx-Xxxxxxx
XXXXXXXXXXX
For the attention of Legal Department
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MGI PHARMA INC.
0000 Xxxx Xxx Xxxxxxxx Xxxx
Xxxxx 000
Xxxxxxxxxxx
XX 00000-0000, XXX
For the attention of: Manager, Legal Affairs
With copy to:
Xxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxxx, XX 00000
For the attention of: Xxxxxxx X. Xxxxx
13.3 Binding Effect
Subject to the provisions of article 13.6 herein, this Agreement shall
inure to the benefit of, and be binding upon, the respective successors
of the Parties.
13.4 Waiver
The failure of a Party to insist upon strict performance of any of the
terms and conditions of this Agreement by the other Party shall not
constitute a waiver of any of the provisions hereof and no waiver by a
Party of any of said terms and conditions shall be deemed to have been
made unless expressed in writing and signed by such waiving Party.
13.5 Interpretation
13.5.1 The language of this Agreement is English. No translation into any
other language shall be taken into account in the interpretation
of the Agreement itself.
13.5.2 The headings in this Agreement are inserted for convenience only
and shall not affect its construction.
13.5.3 Where appropriate, the terms defined in Article 1 hereabove and
denoting a singular number only shall include the plural and vice
versa.
13.5.4 References to any law, regulation, statute or statutory provision
includes a reference to the law, regulation, statute or statutory
provision as from time to time amended, extended or re-enacted.
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13.6 Assignment
This Agreement cannot be transferred, sublicensed, assigned or otherwise
disposed of (by operation of law or otherwise) by MGI without the prior,
written authorization of HBP, which authorization shall not be
unreasonably withheld, provided however that MGI shall be entitled to
assign this Agreement in conjunction with the assignment of the License
Agreement in accordance with the terms and conditions thereof. HBP shall
have the right to assign or transfer, in whole or in part, this Agreement
to any of its Affiliates.
13.7 Statements to the Public
Neither HBP nor MGI shall make or procure or permit the making of any
announcement or statement to the public with respect to this Agreement,
its subject matter or any ancillary matter without the prior consent of
the other Party, which consent shall not be unreasonably withheld. The
wording and the timing of any press release or of any other announcement
and/or statement to the public shall have to be agreed upon in advance
between the Parties.
Nothing herein shall prohibit MGI from disclosing information to the
extent required by the U.S. Securities and Exchange Commission, Nasdaq or
other similar authorities. It is however understood and agreed that (a)
the contents of any copy of this Agreement, or of any other agreement
between the Parties, which has to be sent to the SEC shall have to be
previously agreed upon between the Parties and shall be in redacted form
to maintain the confidentiality of proprietary and/or competitivity
sensitive information, and (b) MGI shall use its best efforts to obtain
authorization by the SEC to keep confidential any information which is
deemed to be confidential by the Parties or any of them or which may, in
either Party's opinion, put a competitive advantage to third parties.
13.8 Expenses
Unless specifically and expressly provided for to the contrary in this
Agreement, each of the Parties shall bear its own expenses incurred in
connection with the performance of this Agreement.
13.9 Survival
The following provisions shall survive expiration or termination of this
Agreement for any reason: Articles 1 (whole clause), 6 (whole clause), 8
(whole clause), 9 (whole clause), 12.4 through 12.6, 13 (whole clause),
15 (whole clause) and 16 (whole clause).
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ARTICLE 14 - APPENDICES
14.1 The following Appendices shall be an integral part of this Agreement:
Appendix 1: Products
Appendix 2: Price
ARTICLE 15 - LAW TO GOVERN AND ARBITRATION
15.1 This Agreement shall be governed by and construed in accordance with the
law of Switzerland.
15.2 It is the express decision of the Parties that any dispute which may
arise between the Parties concerning this Agreement, which cannot be
settled amicably, shall be submitted to arbitration for final decision.
Also, any dispute as to the applicability of the arbitration clause shall
be subject to arbitration. Notwithstanding the above, each Party
expressly reserves the right to seek judicial relief from a court of
competent jurisdiction if the other Party is or appears to be in
violation of such other Party's obligations of non-use and non-disclosure
under Article 9 above, including, without limitation, any injunction or
other preliminary relief.
15.3 It is expressly agreed that arbitration shall be held in English language
in Geneva (Switzerland) and conducted under the Rules of Arbitration of
the International Chamber of Commerce. The court of arbitration shall
consist of three arbitrators. Each Party is entitled to nominate one
arbitrator. If, within one month after receipt of the request for
arbitration filed by one Party, the other has not yet appointed an
arbitrator, such arbitrator shall be appointed by the International Court
of Arbitration of the International Chamber of Commerce on request of the
first Party. The two arbitrators shall nominate the president of the
court of arbitration, who shall be a lawyer qualified to practice and
currently practicing as an attorney-at-law or as a judge. If they cannot
come to terms within one month, the president of the court of arbitration
shall be nominated by the International Court of Arbitration of the
International Chamber of Commerce, on request of the more diligent Party.
15.4 If one of the arbitrators is unable to fulfil his/her duties for any
reason the Party having nominated him/her shall nominate another
arbitrator within one month,
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otherwise this arbitrator will be nominated by the International Court of
Arbitration of the International Chamber of Commerce.
15.5 If the arbitrators or the president have to be replaced, the proceedings
do not have to be started anew and will continue at the point where they
were stopped.
15.6 The court of arbitration is hereby expressly instructed to act with most
diligence and to keep any term as short as possible and to render the
decision as soon as possible.
15.7 The Parties hereby stipulate that any arbitration hereunder shall be
subject to the following rules: (a) the arbitrators may not award or
assess punitive damages against either Party; and (b) each Party shall
bear its own costs and expenses of the arbitration and one-half (1/2) of
the fees and costs of the arbitrators, subject to the power of the
arbitrators, in their sole discretion, to award all such reasonable
costs, expenses and fees to the prevailing Party.
15.8 The Parties agree that the arbitrator's award shall be the sole and
exclusive remedy between them regarding any claims, counter-claims,
issues or accountings presented or pled to the arbitrator and that any
costs, fees or taxes incident to enforcing the award shall be, to the
maximum extent permitted by law, charged against the Party resisting such
enforcement.
15.9 Notwithstanding the foregoing, any Party may bring a case of action
against the other Party before any court of competent jurisdiction at the
domicile of the defendant Party, if and to extent that any arbitral award
rendered in the arbitration proceedings is unenforceable.
15.10 Subject to the provisions of Article 15.9, in the event that an award is
rendered pursuant to this Article 15 by an arbitrator in favor of HBP,
the Parties acknowledge and agree that such award shall be enforceable by
HBP, and MGI hereby consents to the exclusive jurisdiction for purposes
of enforcement of any such award against MGI to the United States
District Court for the District of Delaware, or, if jurisdiction or venue
cannot be laid therein, the jurisdiction of any courts in the State of
Delaware. Each of the Parties hereby consents to the exclusive
jurisdiction of such courts (and of the appropriate appellate courts) for
the purposes set forth above.
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ARTICLE 16 - ENTIRETY OF AGREEMENT AND SEVERABILITY
16.1 This Agreement supersedes all prior agreements and understandings,
whether oral or written, made by either Party or between the Parties and
constitutes the entire Agreement of the Parties with regard to the
subject matter hereof. The Parties however acknowledge and understand
that (a) the existence and validity of this Agreement depend upon and are
conditional upon the existence and validity of the License Agreement and
(b) in case of any discrepancy between the License Agreement and this
Agreement, this Agreement shall be construed in a manner consistent with
the License Agreement. This Agreement shall not be considered extended,
cancelled or amended in any respect unless done so in writing and signed
on behalf of the Parties hereto.
16.2 The Parties hereby expressly state that it is the intention of neither
Party to violate any rule, law and regulations. If any provision of this
Agreement is rendered invalid or unenforceable, the Parties agree to
renegotiate such provision in good faith and to replace it with valid and
enforceable provisions in such a way as to reflect as nearly as possible
the intent and purpose of the original provision.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
in duplicate by their duly authorized officers.
For and on behalf of For and on behalf of
HELSINN BIREX PHARMACEUTICALS Ltd MGI PHARMA, INC.
/s/ Xxxxxxxx Xxxxxxx /s/ Xxxxxxx X. Xxxxxxx
-------------------------- --------------------------
Xxxxxxxx Xxxxxxx Xxxxxxx X. Xxxxxxx
Proxy President and Chief Executive
Officer
/s/ Xxxxxx Xxxxxxx /s/ Xxxx X. Xxxxxxx, Xx.
-------------------------- --------------------------
Xxxxxx Xxxxxxx Xxxx X. Xxxxxxx, Xx.
Proxy Executive Vice President
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