HEADS OF A LICENSE AND SUPPLY AGREEMENT
between
IgX Corporation a company existing and organized under the law of the State of
Delaware, having an office at Xxx Xxxxxxxxxxx Xxxxxx, Xxxxxx XX 00000, X.X.X.
(hereinafter referred to as IgX)
and
XXXXX X.X., a company existing and organized under the laws of Argentina, having
an office at Xxxxxx 000, 0000 Xxxxxx Xxxxx, Xxxxxxxxx Argentina (hereinafter
referred to as GADOR)
WHEREAS
IgX has applied for and was granted by the US Patent and Trade Xxxx Office (PTO)
a Patent related to the Treatment of Intestinal Parasitosis by Enteral
Administration of Hen Egg Yolk Antibodies, namely US Patent 5,753,228, covering
a method for treating Cryptosporidium parvum;
IgX filed a continuation application to said Patent, presenting remaining groups
of Claims to the hen egg yolk antibodies of the invention; Methods for making
the hen egg yolk antibodies; and Pharmaceutical formulations;
IgX filed a continuation-in-part application to said Patent disclosing a reduced
lipid formulation of egg yolks having antibodies to Cryptosporidium parvum;
IgX filed a US Patent provisional application, completed by a utility
application covering an Anti-Cryptosporidium parvum Preparation, disclosing
monoclonal antibody preparations that can neutralize Cryptosporidium parvum
organisms;
IgX filed a US Patent applications covering Hyperimmune Hen Egg Yolk Antibodies
to Clostridium difficile and Methods for its Use disclosing preparation of hen
egg yolks from hens that are hyperimmunized to Clostridium difficile and methods
for their use in treating Clostridium difficile infections;
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GADOR carries on the business of manufacturing and selling pharmaceutical
products;
IgX wishes to provide GADOR, IgX's technology and all other information and know
how related to the treatment of Cryptosporidium parvum and Clostridium difficile
infections in order to enable GADOR to manufacture finished pharmaceutical
products with said indications;
IgX wishes to supply GADOR with the bulk active ingredient necessary to
manufacture the finished pharmaceutical products;
Furthermore, Igx wishes to xxxxx XXXXX a license to use, manufacture, have
manufactured and sell the finished pharmaceutical products, using the bulk
active ingredient and the technology provided by IgX for any and all aspects of
the manufacturing, registration, marketing and commercialization of the finished
pharmaceutical products;
GADOR wishes to obtain from IgX the license and wishes to source itself of the
bulk active ingredient from IgX;
THEREFORE IgX and GADOR agree as follows:
DEFINITIONS: In this Agreement hereinunder the following terms will have the
meanings set out below:
Affiliate: shall mean in the case of either Party any legal entity controlling,
controlled by or under common control with that Party. A legal entity shall be
deemed to control another legal entity if it has the power directly or
indirectly to control the management or policies of the other entity.
BAI: shall mean Bulk Active Ingredient manufactured and supplied to GADOR by IgX
or IgX's designee and serving as active substance for the Products, in
accordance with the standards, specifications and formulae established in
Exhibit A for said Bulk Active Ingredient.
GADOR's designee: shall mean GADOR'S sub-licensees or sub-distributors in the
Territory that may be or may be not GADOR's Affiliate.
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IgX's designee: shall mean alternative supplier of the BAI designated by IgX,
that may be or may be not IgX's Affiliate.
License: shall mean license granted by IgX to GADOR or GADOR's Affiliate to use,
manufacture, have manufactured and sell the Products, using the Patented
Technology as well as the BAI for any and all aspects of the manufacturing,
registration, marketing and commercialization of the Products.
Patented Technology: shall mean Technology covered by Patents.
Patents: shall mean IgX's Patents issued in the Territory.
Products: shall mean finished pharmaceutical products for the indications of
Cryptosporidium parvum and Clostridium difficile infections manufactured by
GADOR under the License and using the BAI as active substance.
Technology: shall mean all scientific and/or medical and/or technical
data, information and know how, including those referred to in IgX's US
Patents and Patent applications related to the treatment of Clostridium
difficile infections and procedures, methods, techniques and materials,
including the BAI as hereinabove defined, related to the manufacture of
fit and merchantable pharmaceutical products with said indications.
Territory: shall mean Mexico and all countries of Central America and South
America, with the exception of Brazil.
1. GRANT.
IgX hereby grants to GADOR the License and GADOR hereby accepts it upon
the terms hereinafter set out. License shall be exclusive for the Territory.
2. PRODUCTS REGISTRATION AND LAUNCHINGS. TRADE MARKS.
2.1 GADOR shall handle all registration work and other contacts with
governmental authorities of the Territory in order to obtain all regulatory
clearances and approvals necessary for the free sale of the Products. IgX shall
promptly and adequately deal with scientific, technical and medical queries
raised by GADOR or
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by the health authorities of the Territory and shall supply the BAI free of
charges in such reasonable quantities that may be necessary for the conducting
of all of the studies related to such authorizations. IgX shall perform Phase I,
Phase II and Phase III registration studies and shall bear all costs related to
such studies. Additional registration studies required by regulatory
authorities in the Territory as part of the registration process shall be
performed by GADOR at GADOR'S expense but IgX shall supply the BAI required for
said studies, free of charge as provided hereinabove. Expenses and official fees
charged for the registration application shall be borne by GADOR. GADOR shall
operate in all matters related to the registration processes with the same
diligence and under the same conditions as it would apply to its own products.
2.1.1 Pursuant to IgX's obligation as set in sub-Article 2.1 hereinabove, IgX
will at its cost:
2.1.1.1 Furnish to GADOR in a timely manner the documentation and information
referred to in sub-Article 2.2.1 hereinunder, including the Phase I, Phase II
and Phase III related studies and the Drug Master File (DMF) of the BAI, in
order to enable GADOR to build the registration dossier mentioned in said
sub-Article and any other information GADOR may reasonably require for the
grant, maintenance, variation or renewal of the Products' registration.
2.1.1.2 Meet requisitions made upon it from regulatory authorities in relation
to the BAI or the Products in the Territory in a timely manner but after full
disclosure and consultation with GADOR.
2.1.1.3 Promptly assist GADOR, when reasonably required by GADOR to do so, to
meet requisitions made of GADOR from regulatory authorities in relations to the
BAI or the Products in the Territory in a timely manner, but in any event,
before expiration of any time set by the regulatory authority.
2.1.1.4 Reimburse GADOR for payment of any consultant's fee any charges made by
the relevant regulatory authority which are incurred as a result of IgX's
failure to fulfil its registration related obligations as set hereinabove.
2.1.2 IgX warrants that all information to be supplied to GADOR in relation with
the BAI and the Products shall be true and ascertainable and that IgX is
legally entitled
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to supply said information.
2.2 Pursuant to sub-Article 2.1. GADOR or GADOR'S designee shall:
2.2.1 Submit to the health authorities of Argentina an application for the
Products' registration within 180 days as from the date GADOR is in possession
of all pertaining information to the extent reasonably available, necessary to
build a registration dossier for an Abbreviated New Drug Application (ANDA),
duly translated. Said information shall include due copies of regulatory
approvals of the Products (Free Sales Certificates) in any of the following
countries: (I) USA, (ii) Japan, or EC countries.
2.2.2 Launch the Products in the Argentine market within 180 days as from the
date Free Sales Certificate for the Products and all other material clearances
set by the regulatory authorities or governmental agencies of Argentina are
granted.
2.2.3 Submit registration applications for the Products in all other countries
of the Territory within 270 days as from the earliest date GADOR is in position
to deliver material evidence that the Products are being marketed in Argentina.
(Proof of Marketing)
2.2.4 Launch the Products in each of the countries referred to in sub-Article
2.2.3 hereinabove within 180 days as from the date Free Sales Certificates for
the Products and all other material clearances set by the regulatory authorities
or governmental agencies of said countries are granted.
2.3 Wherever legal and possible, registrations for the Products shall be applied
for in the name and on behalf of IgX. In those countries where due to mandatory
regulations the registrations shall be applied for in GADOR'S or GADOR's local
designee's name, GADOR irrevocably agrees to immediately transfer or to cause
its local designee to immediately transfer such registrations to IgX or to IgX's
designee, at the expiration or termination of this Agreement.
2.4 License agreed upon in this Agreement includes the use by GADOR while this
Agreement is in force, free of charge, of the Product Registration and Free
Sales Certificates in the Territory for any and all purposes related to the
scope of the License as defined hereinabove.
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2.5 Products shall be marketed and sold under GADOR's trademarks.
IgX acknowledges it will obtain no proprietary interest in such
trademarks. Notwithstanding the foregoing, on the packaging or package
inserts or literature of the Products, where appropriate, it shall be
clearly and distinctively stated that the Products are of IgX
Corporation's research.
3. EARLY TERMINATION.
IgX shall be entitled to terminate this Agreement in case that
due to GADOR's fault GADOR shall fail to perform its obligations as set
in sub-Articles 2.2.1. to 2.2.4. hereinabove and does not remedy such
failure within ninety (90) days of notice given by IgX to GADOR.
4. EXCLUSIVITY. REVOCATION OF EXCLUSIVITY.
4.1 License granted to GADOR shall be exclusive in the Territory.
4.2 Exclusivity so granted shall be conditional and therefore shall be
revocable by IgX pursuant to the provisions agreed upon in sub-Article
4.3. hereunder.
4.3 Notwithstanding GADOR's performance of its obligatiions as set in
sub-Articles 2.2.1 to 2.2.4 hereinabove, IgX shall have the option to
revoke exclusivity granted to GADOR in each of the affected countries of
the Territory, provided that all of the following concurrent conditions
take place:
4.3.1 That said option is exercised only once during the term of the
Agreement in the affected country of the Territory.
4.3.2 That said option is exercised not before five (5) years as from
the date of launching of the Products in the affected country of the
Territory, nor later than six (6) years as from the aforesaid launching
date.
4.3.3 That during the period elapsed as from the launching of the
Products and due to GADOR'S fault, a substantial sales operation of the
Products to the reasonable extent that local market may permit and based
on Product's diligent promotion and distribution, has not been achieved
by GADOR in the affected country of the
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Territory.
4.3.4 That IgX adequately substantiates having a firm offer in writing to
commercialize the Products in the affected country of the Territory, by a
serious and reputable pharmaceutical company, on basis of terms similar to those
granted to GADOR, but warranting a significant incremental of sale performance
with a minimum product sale guarantee.
4.4 As from the date of revocation by IgX of the exclusivity granted to GADOR
pursuant to provisions of sub-Article 4.3 hereinabove, GADOR shall perform its
obligations in the affected country of the Territory as a most favored
non-exclusive licensee and only 50% (fifty per cent) of due royalties shall be
payable by GADOR.
4.5 As from the date of revocation of the exclusivity granted to GADOR pursuant
to provisions of sub-Article 4.3 hereinabove and without prejudice of its own
forthgoing activities as a non-exclusive licensee, GADOR shall act as sole and
exclusive supplier of the Products to any other non-exclusive licensee which may
be appointed by IgX in the Territory. GADOR and the non-exclusive licensee
appointed by IgX shall agree on the terms for the provision of the Products and
Products shall be commercialized in the respective markets of the Territory by
GADOR and the non-exclusive licensee under conditions similar to those of a
co-marketing agreement.
5. PATENT PROTECTION.
5.1 IgX shall protect the licensed Technology, duly applying for and obtaining
patents in the Territory covering IgX relevant patentable materials, devices and
procedures related to the Technology.
5.1.1. During the term agreed upon in sub-Article 8.1 hereinduer, Patents'
maintenance and Patents' defense in the Territory, including costs, shall be of
IgX exclusive responsibility.
5.2 IgX warrants that to the best of its knowledge all Patents shall be genuine,
valid and fit and that IgX has sole title to them. Nevertheless, IgX shall be
liable and therefore shall hold GADOR harmless from and against any and all
loss, liability, damage, fees, costs, judgment and prosecution resulting from
the infringement of the Technology and of the Patented Technology of
Intellectual Property rights of a
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third Party.
5.3 In the event of a suspected infringement of IgX's patent rights in the
Territory by third Parties with respect to any and all aspects of the Patented
Technology, both Parties will consult with each other to determine the
appropriate strategy to attempt to prevent such infringement.
5.4 License shall be comprehensive of all and any improvement made on behalf of
IgX in the patented Technology.
6. SUPPLY OF THE INGREDIENTS.
6.1 IgX or IgX's designee shall supply the BAI in bulk in the form of
lyophilized or air dried product suitable for formulation, unless otherwise
agreed by the Parties.
6.2 BAI will be manufactured in conformity with the codes of Good Manufacturing
Practice (GMP) applicable in the USA and in the countries comprising the
Territory; will be of merchantable or satisfactory quality; will conform with
the requirements of the Products registrations granted in the USA or within the
Territory; will meet any other pharmacopeial or regulatory requirements of the
relevant regulatory authorities in the Territory and will conform in all
respects with the standards, specifications and formulae set in Exhibit A and
the corresponding Quality Specifications.
6.3 Purchase procedures, forecast of estimated requirements, term for the
delivery, liabilities and all other conditions related to the supply shall
comply with the following provisions:
6.3.1 GADOR will annually provide IgX with a forecast of its anticipated
requirements for the BAI for each calendar year and will update that forecast on
a six (6) monthly basis.
6.3.2 GADOR will by written notice place purchase orders for the BAI with IgX
specifying quantities and delivery dates. Delivery dates shall be in the range
of thirty (30) to ninety (90) days as from the receipt of the order by IgX. IgX
will confirm the purchase orders within seven (7) days of their receipt. IgX
will supply the ordered quantities of the BAI by the confirmed delivery dates
provided that the ordered
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quantities are less than or equal to 1.5 times the anticipated requirements
under sub-Article 6.3.1 hereinabove.
6.3.3 Shipment of the BAI shall be via airfreight and will be based on one of
the appropriate INCOTERMS (1990 edition) chosen by GADOR.
6.3.4 Supplies of the BAI shall conform in all respects with the provision of
sub-Article 6.2 hereinabove and BAI supplied pursuant to any single purchase
order will be sourced preferably from a single production lot. With each
delivery of the BAI, IgX shall supply the appropriate Protocol of Analysis. BAI
not complying with said conditions will be deemed to have a defect. IgX assumes
all risk of loss and indenmities and will hold harmless GADOR form and against
any loss, liability, damage, fees, costs, expenses, suits, claims, judgement
and/or prosecution directly or indirectly arising or resulting from any defect
of the BAI, save and except to the extent that any defect is due to the
negligence of GADOR. Said warranty shall apply to the event of voluntary or
mandatory recall of the Products which is materially attributable to the BAI or
which results from any act or omission of IgX. Reciprocally GADOR shall hold
harmless and indemnify IgX on the same conditions if the recall of the Products
is not materially attributable to the BAI or which has not resulted from any act
or omission of IgX. GADOR shall be entitled to ascertain whether the BAI
conforms to the above set requirements and may reject the BAI giving IgX written
notice of its rejection within thirty (30) days of the BAI's receipt at GADOR's
primises. Supplies not objected within thirty (30) days of their receipt shall
be deemed definitively accepted.
6.3.5 IgX or its Affiliates will procure at their own expense from a mutually
acceptable insurer, and maintain in full force and effect as from the launching
of the Products in the Territory throughout the continuance of this Agreement
and for five (5) years thereafter a product liability insurance with a single
limit liability of not less that US$5,0 million in one claim and in the
aggregate noting the interest of GADOR under this Agreement in the policy.
6.3.6 GADOR and IgX, from time to time, shall modify or further precise in good
faith provisions set in Article 6. hereinabove if conditions related to the
manufacture, marketing and sale of the Products in the Territory should so
require.
6.4 Pursuant to the exclusivity granted to GADOR in Article 4. hereinabove, IgX
shall supply the BAI in exclusivity to GADOR in the Territory and GADOR shall
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avail itself of the BAI in exclusivity from IgX.
7. PRICE AND ROYALTIES.
7.1 Price of the BAI shall be of up-to twenty percent (20%) of the net sales of
the Products. Said price and payment conditions are agreed on separately. Net
sales shall mean Gross sales (ex-factory sales) less deduction for the following
to the extent actually paid or allowed and not reimbursed by any Party:
(a) transportation charges including insurance.
(b) sales and excise taxes and duties paid or allowed and any other sales
or government charges imposed on the sale of the Products.
(c) normal and customary trade, quantity and cash discounts allowed.
(d) allowances, charge backs, and credits to customers on account of return
of the Product or on account of retroactive price reductions affecting the
Products.
7.2 GADOR shall pay IgX a royalty of up to ten percent (10%) of the net sales
of the Products, as defined hereinabove in sub-Article 7.1 for the license of
the Patented Technology in the Territory. Said royalty and payment conditions
are agreed on separately.
7.3 No other down-payments, up-front license fees nor milestone payments shall
be required from GADOR by IgX for the performance of IgX obligations as agreed
hereupon related to the license and supply of BAI for the use, manufacture and
sale of the Products.
8. TERM OF THE AGREEMENT.
8.1 The term for this Agreement shall be from the effective date of the
Agreement until the expiration of the last to expire of any of the patent rights
of which but for this license GADOR would infringe by any activity permitted
under this license in the Territory.
8.2 Notwithstanding the foregoing, GADOR shall be entitled to extend the term
of this Agreement beyond the life of the Patents. Extension shall be effective
whilst sales operations subsist in any or all of countries of the Territory.
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8.3 In case GADOR makes use of the entitlement referred to hereinabove in
sub-Article 8.2, only provisions of this Agreement related to the supply of the
BAI shall survive. Therefore no royalties at all shall be payable by GADOR to
IgX nor shall IgX be liable for any further patent protection of the Technology
in the Territory.
9. BOOKS AND RECORDS.
GADOR and GADOR'S designees shall keep full, and accurate books of account
and other records in accordance with local guidelines of generally accepted
accounting principles containing all particulars which may be necessary to
ascertain the discharge by GADOR of all obligations undertaken in this Agreement
including the payment of the price of the BAI and royalties, for a period of
five years after the end of the period of time to which they relate. These books
shall be avaliable for inspection as to those portions relevant to this
Agreement by an independent certified public accountant appointed by IgX, during
normal business hours.
10. PACKING AND DISTRIBUTION.
GADOR shall provide IgX with drafts and samples of the proposed materials
related to the packaging of the Products as well as of the package inserts.
Distribution of the Products shall be sole responsiblity of GADOR.
11. COMMITTEE. NOTICES.
A Committee comprised on GADOR'S behalf by its Executive Directors Messrs.
Xxxx Xxxxxx and Xxxxxxx Xxxxxxx Xxxxxxxx and on IgX behalf by its President and
Chief Executive Officer Xx. Xxxxx and its Senior Vice President Xx. Xxxxxxx
Xxxxx shall serve as a conduit for communications between the Parties. Said
members shall meet whenever necessary and all relevant notifications and or
communications between Parties related to this Agreement shall be delivered to
the attention of the respective member of the Committee and shall be dealt with
by said members.
Said notice shall be made and sent by registered airmail postage prepaid, or
by prepaid cable, telex or facsimile with simultaneous mailing of a copy
thereof by prepaid courier, registered mail or registered express postage, to
the addresses of the Parties stated above or to such other address as shall be
designated by the Parties in
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written notice to the other Party, complying as to delivery with the terms of
this Article.
12. RELATIONSHIP OF THE PARTIES.
This Agreement shall not constitute any of the Parties the agent, or legal
representative of the other Party. This Agreement creates no relationship of
joint adventures, partners, associates, or of principal and agents between the
Parties, for both Parties are acting as principals.
13. ASSIGNMENT.
Neither Party shall be entitled to assign its rights or obligations
hereunder or any part thereof to any third Party without the consent in writing
of the other. Such consent shall not be unreasonably withheld, especially when
assignment of rights does not entail declination of obligations hereunder.
Nothwithstanding the foregoing, GADOR may designate sub-licensees and
sub-distributors of the Products in the Territory that may be or may be not
GADORS's Affiliates and IgX may designate an alternative supplier of the BAI,
that may be or may be not IgX Affiliate.
14. FIRST REFUSAL RIGHT.
IgX grants hereunder to GADOR a first refusal right related to licenses of
pharmaceutical products IgX is in course of developing or may develop in the
future and which IgX may wish to license and/or supply in the Territory.
15. FORCE MAJEURE.
Neither Party shall be liable to the other for any failure or delay on its
part in fulfilling its obligations hereunder to the extent that such failure or
delay is due to circumstances beyond its control which it could not have avoided
by the exercise of reasonable diligence (hereinafter referred to as "force
majeure"). The Party affected by force majeure shall give notice thereof to the
other as soon as practicable, at the same time indicating the anticipated
duration thereof, and shall use all commercially reasonable efforts to resume
performance of its obligations as soon as possible.
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16. CONFIDENTIALITY.
16.1 The Parties undertake to keep strictly confidential and take all
applicable measures to ensure that their employees will keep strictly
confidential all information that the Parties may have or may acquire hereunder,
and which has not been previously published. Confidential Information shall mean
all technical information and data including those related to markets and sales,
market research, pricing and profitability, made available directly or
indirectly by one Party to the other Party concerned in oral, written, graphic
or machine readable form.
16.2 Those Parties shall disclose Confidential Information only to those
employees and their agents who need to know the Confidential Information for
purposes mentioned in this Agreement. The Parties warrant they will arrange
agreements with those of its employees or agents having access to Confidential
Information, prohibiting unauthorized disclosure or use of the Confidential
Information. The disclosure to clinicians, government officials and governmental
agencies shall be allowed insofar as such disclosure is specifically required
for the due performance of this Agreement and such disclosure is limited to
reasonable extent.
16.3 The obligation arising from this Article shall survive ten (10) years the
termination of this Agreement.
17. EXTRAORDINARY TERMINATION.
17.1 One of the Parties shall be entitled to extraordinary termination of
this Agreement at any time in either of the following events:
17.1.1 if the other Party should commit a material breach of this Agreement and
should fail or be unable to rectify that breach within ninety (90) days of the
receipt of notice specifying the breach; or
17.1.2 if the other Party should go into liquidation otherwise than for the
purpose of merging or amalgamation; or have a petition presented for bankruptcy
or winding up which is not dismissed within ninety (90) days of presentation; or
have a receiver appointed of any of its assets; or entered into any composition
or similar arrangement with its creditors; or
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17.1.3 If a Force Majeure situation prevents a Party from performing its
obligations under this Agreement and said situation continues for more than
six (6) months. Notice of the termination shall be given to the other Party with
an anticipation of at least thirty (30) days to the effective date of
termination.
18. EFFECTS UPON TERMINATION AND EXPIRATION.
18.1 Termination and expiration of this Agreement shall be without prejudice to
all rights and obligations of the Parties arising or having effect following
termination.
18.2 Upon termination of this Agreement if the registration of the Products has
not yet been granted GADOR shall transfer to IgX or to IgX's designee, free of
any charge, the right to the full dossier and to all data submitted to the
regulatory Authorities.
19. SEVERABILITY.
If any or more of the provisions of this Agreement shall be held
to be invalid, illegal or unenforceable it shall be deleted herefrom
without affecting the validity, legality or enforceability of the
remaining provisions hereof unless the effect of such deletion would be
to prejudice significantly the interest of either Party, in which event
this Agreement shall automatically terminate unless the Parties
otherwise agree. The Parties shall use their best efforts to substitute
for the deleted provision, a valid, legal and enforceable provision
which implements the purpose hereof.
20. EFFECTIVE DATE.
This Agreement shall come into full force and effect as from the
date below written.
21. GOVERNING LAW.
The validity of this Agreement, the rights and obligations of the
Parties hereunder shall be construed and determined under the laws of
the State of New York.
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22. ARBITRATION.
All disputes arising in connection with this Agreement shall be finally
settled under the Rules of Conciliation and Arbitration of the International
Chamber of Commerce by one (1) or three (3) arbitrators appointed in accordance
with the said rules. The language of the arbitration shall be English. Place of
arbitration shall be the country of the defendant Party.
IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be executed
in duplicate by their duly authorized representative as of the date duly written
below.
XXXXX X.X. IgX CORPORATION
Buenos Aires, 7th. of August of 1998. Buenos Aires, 7th. of August of 1998.
--------------------------------- --------------------------------------
by: Xxxxxxx Xxxxxxx Xxxxxxxx On authorization of Xxxxxx Xxxxx
title: Executive Director title: President and CEO
by: Xxxxxxx Xxxxx
title: Senior Vice President
---------------------------------
by: Xxxx Xxxxxx
title: Executive Director --------------------------------------
by Xxxxxxx Xxxxx
title: Senior Vice President
FIRMAS CERTIFICADAS DE LOS SRES. XXXXXXX XXXXXXXX, XXXXXX y XXXXX -- en SELLO DE
ACTUACION NOTARIAL numero C 005619810.-- DE ESTA CERTIFICACION SE EXPIDE EL
ANEXO No. C 003524383.-- BS.AS.7/08/1998.-- CONSTE.--
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