EXHIBIT 10.25
Confidential Execution Copy
FINISHED PRODUCT SUPPLY AGREEMENT
executed as of the date last below written (hereinafter referred to as
"Effective Date") by and between
XXXXXXX PHARMACEUTICA, Naamloze Vennootschap, a business corporation
organised under the Laws of Belgium, having its principal office at
B-2340 Beerse (Belgium), Turnhoutseweg 30 (hereinafter referred to as
"XXXXXXX")
and
BARRIER Therapeutics, Inc., a business corporation organized and
existing under the laws of the State of Delaware and having its
principal office at 000 Xxxxxxx Xxxx Xxxx, Xxxxx 0000, Xxxxxxxxx, Xxx
Xxxxxx 00000 ("BARRIER").
ARTICLE 1: DEFINITIONS
Each term defined below shall, for the purpose of this Agreement, have the
following meaning unless the context clearly requires otherwise and the singular
shall include the plural and vice versa:
1.1 "Affiliate" shall mean, with respect to a given company, any company
which owns or controls at least fifty per cent (50 %) of the voting
stock of such given company, or any other company at least fifty per
cent (50 %) of whose voting stock is owned or controlled by such owning
or controlling company or by the given company.
1.2 "Compounds" shall mean those active ingredients as specified in a
separate Exhibit attached hereto.
1.3 "Know-How" shall mean i) all registration and technical data concerning
the Compound and the Product and ii) all other confidential information
and knowledge which has been or shall be supplied by XXXXXXX at its
discretion to BARRIER during the term of this Agreement, but in each
case, excluding any JJCC Know-How licensed to BARRIER under the License
Agreement.
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1.4 "Finished Product" shall mean a Product wrapped, labelled and packaged
in secondary printed packaging, for use in human medicine, and, subject
to final release by BARRIER, ready for sale to the ultimate consumer,
as specified in a separate Exhibit I attached hereto.
1.5 "License Agreement" shall the agreement dated May 6, 2002 between
BARRIER and XXXXXXX'x Affiliate Xxxxxxx & Xxxxxxx Consumer Products.
1.6 "Manufacture" shall mean all steps and operations involved in the
production of Finished Products starting from pharmaceutical
formulation, packaging, labelling, in-process quality control, internal
release testing, and storage of the Finished Products until delivery
thereof to BARRIER or a party designated by BARRIER. For clarity,
"Manufacture" does not include final release of Finished Products in
accordance with the Regulatory File, which shall be the responsibility
of BARRIER.
1.7 "Product" shall mean the pharmaceutical formulation known as F100
containing miconazole nitrate and zinc oxide as active ingredients as
further described in a separate Exhibit. For clarity, "Product" shall
not include the pharmaceutical formulation known as F114.
1.8 "Regulatory File" shall mean a file holding the application for
obtaining marketing approval for Product in a given country or region,
ready for submission to the appropriate regulatory agency.
1.9 "Specifications" shall mean the specifications of Finished Product as
set forth in Exhibit III hereto which may be modified from time to time
in accordance with Article 7.2.
1.10 "Territory" shall mean the world with the exception of (i) the "JJCC
Countries" as defined in the License Agreement and (ii) the United
States and Canada.
ARTICLE 2: DUTY TO MANUFACTURE AND SUPPLY; RIGHT TO BUY AND USE THE FINISHED
PRODUCT
2.1 Subject to all terms and conditions of this Agreement, XXXXXXX shall
Manufacture and supply to BARRIER on a non-exclusive basis the Finished
Product. Subsequently XXXXXXX grants BARRIER the non-exclusive right to
use, import, have imported, sell and have sold the Finished Product in
the Territory and XXXXXXX grants BARRIER thereby the non-exclusive
right to use the Know-How.
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The right granted in this Article 2.1 shall in no way limit the rights
granted to BARRIER under the License Agreement.
2.2 BARRIER shall sell the Finished Product for its own account and at its
own risk. Without limiting the generality of the foregoing, BARRIER
shall assume all credit risks.
2.3 All rights herein granted are personal to BARRIER. Such rights are
indivisible and non-transferable and BARRIER has no right to grant any
subcontract thereto, except as necessary for BARRIER to distribute and
sell Finished Product through its distributors and similar business
partners.
2.4 XXXXXXX shall provide, at its own cost and expense, all equipment,
machinery, raw materials, active ingredients and labor necessary for
the Manufacture of the Finished Products.
ARTICLE 3: SUPPLY-PRICE-PAYMENT CONDITIONS
3.1. BARRIER commits itself for the duration of this Agreement to buy its
total requirements of the Finished Product for sale in Territory
exclusively from XXXXXXX or a party designated by XXXXXXX, at the
applicable prices.
3.2. The Price ex-works for the Finished Product shall be: tube of 30 gram:
E 1.00 (one Euro) per unit.
3.2. XXXXXXX shall invoice orders at prices in effect at the time of
XXXXXXX'x receipt of such order. BARRIER shall pay XXXXXXX in Beerse in
Euros, within thirty (30) days from the date of the invoice. Invoices
shall be dated the date of shipment.
In the event that BARRIER does not abide by the payment terms agreed
upon, XXXXXXX shall have the right to withhold further supplies and to
require all following payments against irrevocable and confirmed letter
of credit.
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ARTICLE 4: MINIMUM PURCHASE OBLIGATION - ORDERS
4.1. Minimum Purchase Obligation.
BARRIER commits to purchase a total of 1,000,000 (one million) 30 gram
tubes within a period of 24 (twenty-four) months starting from the
Effective Date.
In case this Agreement is terminated for whatever reason except breach
of contract by XXXXXXX but including without limitation termination
under Article 10.3 below, and BARRIER has not yet purchased and paid a
minimum of 1,000,000 (one million) 30 gram tubes on the effective date
of termination, BARRIER shall pay to XXXXXXX a penalty equal to of 0.50
Euro (one half Euro) multiplied by the number of 30 gram tubes that
BARRIER has failed to buy and pay compared to the 1,000,000 (one
million) 30 gram tubes minimum.
4.2. Ordering.
BARRIER will order the Finished Product from XXXXXXX by means of a
purchase order for the Firm Order and XXXXXXX shall ship or cause the
Finished Product to be shipped pursuant to its standard shipping
documents; all such purchase orders shall be sent to the attention of
European Demand Group of the European Logistics Center (ELC), or such
other addressee as indicated by XXXXXXX from time to time.
Each such purchase order, whether printed, stamped, typed or written,
shall be governed by the terms of this Agreement and none of the
provisions of such purchase order shall be applicable, except those
specifying quantity ordered and delivery dates. It is thereby
understood that Firm Orders for the Finished Products shall be sent to
XXXXXXX at a minimum of twelve (12) weeks before the required shipping
date.
4.3. Orders in excess of the forecasted quantity are subject to XXXXXXX'x
approval and XXXXXXX will use its reasonable efforts to execute such
orders, taking into account the quantities of the Finished Product
available to XXXXXXX at the time, the requirements of its other
customers and its own requirements and the production capacity of its
plant.
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4.4. The following minimum quantities of the Finished Product to be ordered
with each order shall apply: 91,000 (ninety one thousand) 30 grams
tubes or a multiple thereof.
4.5. Orders for the Finished Product confirmed by XXXXXXX under Article 4.4.
here above shall be shipped EXW XXXXXXX'X facility (2000 Incoterms) and
the respective obligations of XXXXXXX and BARRIER regarding the
delivery aspects, including but not limited to import and export
licenses and formalities, carriage and insurance aspects, transfer of
risk, cost allocations etc. will be as laid down under the said
Incoterms. The transportation and insurance costs actually incurred by
XXXXXXX or its designee shall be reimbursed by BARRIER.
ARTICLE 5: LABELLING, PACKAGING AND QUALITY ASSURANCE
5.1 At least sixty (60) days prior to first purchase order, BARRIER shall
provide XXXXXXX with the art work and copy of all packaging material,
including package inserts labels and designs etc. On the packages,
labels, insert leaflets and other written information concerning the
Finished Product, no reference will be made to XXXXXXX except if
otherwise required by regulatory authorities, in which case BARRIER
shall promptly inform XXXXXXX in writing of such requirement. BARRIER
shall be solely responsible for compliance of any and all packaging
material, including package inserts labels and designs with applicable
regulations and shall indemnify and hold harmless XXXXXXX against any
and all claims or damages caused by any alleged or actual
non-compliance. In case BARRIER intends to alter all or part of the
packaging material, including package inserts labels and designs, it
shall inform XXXXXXX of such intention sufficiently in advance and
BARRIER shall bear any and all actual costs and expenses incurred by
XXXXXXX as a consequence of such change, including but not limited to
the destruction of expired packaging material and/or inserts and/or
labels.
5.2 The regulatory responsibilities of the Parties, including, without
limitation, standard operating procedures applying to change control
and responsibilities for quality assurance, shall be set forth in a
specific quality agreement (the "Quality Agreement") that will be
attached hereto as Exhibit. To the extent there are any conflicts or
inconsistencies between this Agreement and the Quality Agreement, the
terms and conditions of the Quality Agreement shall take precedence
with respect to matters of a regulatory nature including, without
limitation, standard operating procedures, change control, Adverse Drug
Events, recalls and quality assurance, whereas the terms and conditions
of this Agreement shall prevail with respect to all
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other matters, unless otherwise expressly set forth in this Agreement
or agreed in writing by the Parties.
ARTICLE 6: WARRANTIES
6.1 XXXXXXX warrants that the Finished Products are Manufactured in
compliance with the prevailing GMP Rules, with the Quality Agreement
and with the Specifications.
6.2 Xxxxxxx will release the Product to Barrier under the release testing
procedures currently used by Xxxxxxx for its Daktozin(R) product (the
"Xxxxxxx Release Procedures"). Upon Barrier's or its designee's receipt
of the finished released Product, Barrier or its designee will conduct
two release procedures in accordance with the Regulatory File (the
"Barrier Release Specifications") in addition to the Xxxxxxx Release
Procedures. The Barrier Release Specifications are set forth on Exhibit
II to this letter. Within thirty (30) days following a receipt of a
shipment of Finished Product, BARRIER inform XXXXXXX in writing of any
qualitative and quantitative shortcomings of the supplied Finished
Product. If the shipping documents, batch records and certificate of
analysis are delivered to BARRIER'S designee, XXXXXXX shall also send a
copy of such documents, batch records and certificate of analysis to
Barrier. In the absence of written advice by BARRIER the Finished
Product shall be deemed to be delivered in good and satisfactory
condition, except with respect to hidden defects.
6.3 On the date of dispatch from Xxxxxxx shipping facility; the Finished
Product shipped to BARRIER shall have a remaining shelf life equal to
at least eighty percent (80%) of the normal shelf life as set forth in
the Specifications.
6.4 The warranty obligation assumed by XXXXXXX hereunder with respect to
hidden defects to the Finished Product shall only apply if BARRIER has
notified XXXXXXX not later than fourteen (14) working days after the
defects are discovered and at least ninety (90) days prior to the
expiration of such Finished Product.
6.5 In case of a justifiable claim received by XXXXXXX by registered mail
within the applicable time periods as provided in Article 6.2 and 6.3
above, XXXXXXX shall either replace the defective portion of the
Finished Product when returned, adjust the price for the sale in
question, or correct the shortage fairly and promptly at no additional
cost to BARRIER, but
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under no circumstances whatsoever shall all or any portion of the
Finished Product in question be returned to XXXXXXX without its prior
consent.
6.6 BARRIER shall promote and sell the Finished Product in the Territory
under a trademark and label (name, design, layout, colours, etc.) of
BARRIER which does not look confusingly similar to any trade dress,
trademark or design of XXXXXXX. BARRIER shall be responsible for
assuring the compliance of such label and all other written information
with the local laws and regulations in the Territory.
6.7 BARRIER shall take care that to store the Finished Product in storage
facilities adapted to pharmaceutical preparations and in compliance
with the legal requirements in the Territory.
6.8 BARRIER shall release the Finished Product to the market in compliance
with the release procedures set forth in the Regulatory File.
ARTICLE 7: LICENSES - CONTROL OF CHANGE
7.1 BARRIER shall exercise its best efforts to obtain and maintain at its
own expense and as promptly as possible any government license,
registration or approval to import the Finished Product, to label and
package the Finished Product, to sell the Finished Product in the
Territory and to perform in general this Agreement.
7.2 Parties understand that the Specifications with respect to the
formulation of the Product are the same as the specifications of
XXXXXXX'x Daktozin(R) product. XXXXXXX shall be entitled to alter
Specifications from time to time to align with alterations in the
specifications of XXXXXXX'x Daktozin. In such event XXXXXXX shall
notify BARRIER of its intention in advance in order to reasonably
enable BARRIER to obtain a corresponding variation of the marketing
approval(s) for Finished Product, where necessary. In no event shall
XXXXXXX be under an obligation to continue to supply BARRIER with
Finished Product with non-altered Specifications after a period of six
(6) months has lapsed after the day on which XXXXXXX sent the notice of
its intention to alter Specifications. This Article 7.2. shall take
precedence over anything said to the contrary in the Quality Agreement.
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ARTICLE 8: ADVERSE DRUG EVENTS AND RECALLS
Adverse Drug Event reporting and recalls of Finished Product shall be dealt with
in accordance with the provisions of the Quality Agreement.
ARTICLE 9: TERM
9.1 Unless sooner terminated as hereinafter provided, this Agreement shall
commence on the Effective Date and shall continue in full force and
effectuntil the day on which BARRIER has bought and paid a total of
1,000,000 (1 million) 30 gram tubes of Finished Product as set forth in
Article 4.1. above.
9.2 Without prejudice to Article 4.1, termination of this Agreement
pursuant to Article 11. shall not entitle a Party to claim or seek
indemnification, or any other form of damage or otherwise, make any
claim against the terminating Party by reason or at the occasion of
such termination. Neither Party will in no way be entitled at any time
to any sum or right whatsoever from the terminating Party other than
those which might be payable to it if and when clearly and expressly
provided for under the Agreement.
ARTICLE 10: TERMINATION
10.1 If BARRIER shall default at any time in making any payment required by
this Agreement, or commit any material breach of any covenant or
agreement herein , and shall fail to remedy such default, or remedy
such breach within thirty (30) days after receipt of written notice
thereof by XXXXXXX, or if BARRIER becomes insolvent, XXXXXXX may, at
its option and by written notice, terminate this Agreement and the
rights herein granted immediately without any further prior notice. If
XXXXXXX shall commit any material breach of any covenant or agreement
herein and shall fail to remedy such breach within thirty (30) days
after receipt of written notice thereof by BARRIER, BARRIER may, at is
option and by written notice, terminate this Agreement and the rights
herein granted immediately without any further prior notice.
10.2 This Agreement shall terminate automatically in the event that pursuant
to Article 8.2, BARRIER does not wish to buy Finished Product with
altered Specifications and the period of six months has lapsed.
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10.3 XXXXXXX shall be entitled, but not obligated, to terminate this
Agreement at any time, by way of written notice if, after a period of
twenty four (24) months starting from the Effective Date, BARRIER has
not yet bought and paid a total of 1,000,000 (1 million) 30 gram tubes
of Finished Product.
ARTICLE 11: EFFECTS OF TERMINATION
11.1 On the expiration of the present Agreement, or in case of termination
for any reason, BARRIER shall, without prejudice to the provisions of
Article 11.2. below
(a) immediately cease, upon termination and thereafter, the use of
any Know-How and shall not disclose the Know-How to others;
(b) immediately return to XXXXXXX any original technical material
and Know-How of XXXXXXX then in its possession ;
(c) immediately render adequate and final accounts to XXXXXXX with
respect to any transaction under the present Agreement to
which it has not yet rendered an accounting to XXXXXXX;
(d) promptly effect the payment of the penalty set forth in
Article 4.1, if applicable.
11.2 On the expiration or termination of this Agreement for any reason
whatsoever, BARRIER shall continue to have the right to sell and have
sold the remaining stock of Finished Product following said expiration
or termination.
ARTICLE 12: CONFIDENTIALITY
12.1 BARRIER shall not disclose any Know-How received from XXXXXXX to any
third party without prior written consent of XXXXXXX, except and to the
extent as required by governmental authorities, or except that any of
such Know-How can be shown by BARRIER:
(i) to be in its possession or in the possession of its employees
or an employee of any of its Affiliates prior to such
disclosure to BARRIER; or
(ii) is now or hereafter becomes available as public knowledge or
literature through no fault of BARRIER, patented or otherwise;
or
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(iii) is received by BARRIER from an independent third party who did
not receive the information directly or indirectly from
XXXXXXX.
12.2 The provisions of Article 12.1. shall also apply to Know-How disclosed
by XXXXXXX to BARRIER prior to the execution of this Agreement.
12.3 The obligation of secrecy contained in this Article 12, shall survive
the expiration and/or termination of this Agreement for ten (10) years.
ARTICLE 13: LIABILITY
13.1 Without in any way limiting any liability of XXXXXXX to BARRIER under
this Agreement, as to third parties including governmental authorities,
BARRIER shall be the responsible manufacturer and seller of the
Finished Product in the Territory. BARRIER shall promptly notify
XXXXXXX of any claim or demand made by any third party due to the
alleged defectiveness of the Compounds and/or Finished Product, and
BARRIER shall consult in good faith with regard to the appropriate
reaction to such claim or demand. In any event, BARRIER shall not admit
to any degree of liability to any third parties either for himself or
XXXXXXX before having consulted XXXXXXX and obtained the written
consent of XXXXXXX thereto. XXXXXXX shall defend and hold BARRIER
harmless from and against third party claims and will indemnify BARRIER
for all direct damages costs and expenses related thereto, to the
extent they arise out and are caused by the faulty conduct or
negligence on behalf of XXXXXXX in the manufacturing of the Finished
Product, or in the supply of accompanying information.
13.2 BARRIER shall defend and hold XXXXXXX harmless from and against third
party claims and will indemnify XXXXXXX for all direct damages costs
and expenses related thereto, to the extent they arise out and are
caused by the faulty conduct or negligence of BARRIER, such as but not
limited to the mishandling or misstorage of the Finished Product, the
labelling, to the extent such labeling has been supplied by or at the
direction of BARRIER and sale of the Finished Product or due to any
action or omission of BARRIER to comply with its obligations under this
Agreement. BARRIER commits itself to have proper insurance protecting
XXXXXXX and itself against product liability claims.
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13.3 In no event shall either Party be liable towards the other Party for
any indemnification other than as respectively provided under Article
14.2 and 14.3 or for any indirect, special or consequential damage
whatsoever, including but not limited to financial loss or lost
profits.
ARTICLE 14: INDEPENDENT PARTY
Neither party nor its employees or representatives are under any circumstances
to be considered as employees or agents or representatives of the other. Neither
parties employees or representative have authority or power to bind the other or
contract in other's name.
ARTICLE 15: NOTICES
Any notice required under this Agreement shall be made in writing either by
registered mail or facsimile or by overnight carrier to XXXXXXX and to BARRIER
at their respective addresses first above written or as subsequently changed by
notice duly given. Notwithstanding the above all correspondence with regard to
the Termination of this Agreement shall be by registered airmail or overnight
carrier.
Notices by registered mail shall be deemed to be given three (3) days after
mailing. Notices by facsimile shall be deemed to be given on the date on which
such notice has been given. Notices by overnight carrier shall be deemed to be
given two (2) days after mailing.
ARTICLE 16: MISCELLANEOUS
16.1 This Agreement shall be binding upon and inure to the benefit of both
parties and their respective its successors or permitted assigns.
XXXXXXX shall have the right to assign, transfer or sub-contract whole
or part of this Agreement or any rights or obligations assumed
thereunder to its Affiliates. BARRIER shall have the right, without the
prior written consent of XXXXXXX, to assign or transfer this Agreement
to any person or entity that acquires all or substantialy all of the
stock or assets of BARRIER. BARRIER shall promptly inform XXXXXXX of
the occurrence of such assignment or transfer.
16.2 No damages shall be owed by either Party to the other by reason of this
Agreement or any part of it being held invalid or void at any future
time. If any of the provisions of this Agreement are held to be or
rendered void or unenforceable by or as a result of the decision of any
Court
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or other Tribunal or by the legislation or regulation of any
governmental or similar authorities, the Parties agree that the same
shall not result in the nullity or unenforceability of the remaining
provisions of this Agreement, but that they will use their best efforts
to replace such void or unenforceable provision with a valid and
enforceable provision which will achieve, to the extent possible, the
economic, business or other purpose for said void or unenforceable
provision.
16.3 Save as required by law no announcement or circular in connection with
the subject matter of this Agreement shall be made by or on behalf of
XXXXXXX or BARRIER without the prior approval of the other Party, such
approval not to be unreasonably withheld or delayed. It is agreed and
understood that BARRIER may disclose the existence and terms of this
Agreement in any document that it files with the Securities and
Exchange Commission to the extent that BARRIER is adviced by legal
counsel that such such existence and/or terms should be disclosed to
comply with SEC rules and regulations.
16.4 Neither Party hereto shall be liable to the other Party for failure or
delay in meeting any obligation hereunder due to circumstances beyond
such Party's reasonable control, such as but not limited to strikes,
lockouts, acts of God, riots, war, fire, flood, embargoes, failure of
power, acts of government or of any agency, provided that the Party
affected shall immediately inform the other Party about the cause of
such delay. The Party so affected shall use its best efforts to
eliminate, cure and overcome any such causes and resume performance of
its covenants with all possible speed.
ARTICLE 17: APPLICABLE LAW
17.1 This Agreement shall, in all respects, be subject to substantive
Belgian law except that the Parties explicitly waive the application of
the law of July 27, 1961 (as amended). The U.N. Convention on Contracts
for the international sale of goods shall not apply to this Agreement
or to any sale of goods by XXXXXXX or any of its designee(s) to BARRIER
under this Agreement.
17.2 The Parties hereto expressly agree that any dispute arising out of or
in connection with this Agreement shall be submitted to the exclusive
jurisdiction of the Courts of Turnhout, Belgium.
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ARTICLE 18: ENTIRE AGREEMENT
The present Agreement cancels and supersedes all agreements of any kind related
to the subject matter of this Agreement between XXXXXXX and BARRIER prior to the
Effective Date of this Agreement, other than the License Agreement, which shall
continue in full force and effect and no terms of this Agreement shall amend or
alter the terms of the License Agreement.
ARTICLE 19: TRANSLATION
Any translation of this Agreement shall be submitted for BARRIER's information
only, and it is expressly understood that such a translation does not form part
of the Agreement and that only the English text shall be valid and legal.
IN WITNESS WHEREOF, XXXXXXX and BARRIER have caused this instrument to be
executed in duplicate by their respective duly authorised officers.
ATTEST: BARRIER Therapeutics, Inc.
This 14th day of July 2004
XXXXXX X. XXXXXXX By XXXXXX XXXXXXXX
----------------- ------------------------------
(title) General Counsel (title) Chief Commercial Officer
ATTEST: XXXXXXX PHARMACEUTICA N.V.
This ____ day of July 2004
By XXXXXXX XXXXXX
------------------ ----------------------------------
(title) (title) IVP Pharma Prod.
By XXXXXXXX XXXXXXX
------------------------------
(title) General Manager
