1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUPPLY AGREEMENT
BY AND BETWEEN
SYNTHELABO GROUPE, a French Company having its legal office at 00, Xxxxxx
Xxxxxxx - 00000 Xx Xxxxxxx-Xxxxxxxx (Xxxxxx)
hereinafter referred to as SYNTHELABO
AND
PENWEST PHARMACEUTICALS CO., a Washington State corporation having its legal
office at 0000 Xxxxx 00, Xxxxxxxxx, Xxx Xxxx 00000 (XXX)
hereinafter referred to as PPC
WITNESSETH
WHEREAS,
A) XXXXXX XX, Xxxxxxxxxx 00-00, 00000 XXXXX - XXXXXXX (hereinafter called
"LEIRAS") has developed and is in possession of a medical product
containing Oxybutynin as active ingredient and called Cystrin, and is the
proprietor of valuable know-how, data, skills and other information in
relation thereto.
B) PPC is the owner of TIMERx Controlled Release System and certain patents
pertaining thereto.
C) LEIRAS and PPC have cooperated in a "Development Programme" whereby PPC
developed a slow-release tablet/slow release tablet formulation for LEIRAS'
Cystrin product, adjusting the TIMERx Controlled Release System and have
cooperated in the development and formulation of the Oxybutynin-TIMERx
product, which programme is now completed.
D) PPC and LEIRAS agreed that PPC shall supply SYNTHELABO with the TIMERx
Controlled Release System to enable SYNTHELABO to manufacture the slow
release formulation of LEIRAS' Cystrin product, hereinafter the PRODUCT.
PPC and SYNTHELABO have, concurrently with this Agreement entered into a
License Agreement regarding the licensing to SYNTHELABO of certain rights
under certain
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PPC patents (the "PATENT RIGHTS") and other rights as they relate to the
manufacture and sale of the PRODUCT (the "License Agreement").
E) The parties also wish to enter into arrangements for the manufacture and
supply of above said product on the basis of the terms and conditions set
out below.
NOW THEREFORE, the parties agree as follows
ARTICLE 1: DEFINITIONS
The terms defined in this article shall, for all purposes of this Agreement,
have the meanings specified in this Article 1 (applicable both to the singular
and the plural forms).
1.1 AGREEMENT: shall mean this document and all attachments or exhibits.
1.2 SUBSIDIARY: shall mean any corporation or other business entity of which at
least fifty percent (50%) of the total voting rights is owned by
SYNTHELABO.
1.3 CALENDAR YEAR: shall mean each consecutive twelve-month period beginning
January 1st, and ending December 31st.
1.4 OXYBUTYNIN: shall mean Oxybutynin and its pharmaceutically acceptable
salts, enantiomers and active metabolites.
1.5 TIMERx: shall mean the slow-release system developed by PPC and whose
specifications are set out in the Appendix 1 hereinafter attached.
1.6 PRODUCT: shall mean the final slow-release tablet dosage form of LEIRAS'
Cystrin medical product with Oxybutynin as active ingredient using the
TIMERx Controlled Release System referred to in item C) in the WHEREAS
section of this Agreement and containing 10mg of Oxybutynin and
corresponding in all respects with the specifications as defined in
Appendix 1 attached hereto (which is the same as ANNEX A to the License
Agreement).
1.7 TERRITORY: shall mean the TERRITORY defined in ANNEX C to the License
Agreement.
1.8 PPC MANUFACTURING TECHNOLOGY: shall have the meaning defined in the License
Agreement.
1.9 HEALTH REGISTRATION: shall have the meaning defined in the License
Agreement.
References to Sections, Clauses, and Appendices, are to Sections, Clauses, and
Appendices of this Agreement, except where noted otherwise.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ARTICLE 2: SUBJECT
2.1 SYNTHELABO entrusts PPC with the manufacture of the TIMERx.
2.2 PPC shall supply SYNTHELABO with such quantities of said TIMERx as the
latter shall order.
2.3 TIMERx shall be supplied in the form detailed in Appendix 1 hereinafter
attached.
2.4 The manufacturing operations are:
o reception, storage of raw materials and packaging, material of the
TIMERx,
o manufacturing and packaging of the TIMERx,
o control and/or identification of raw materials, packaging material,
o packing and storage of the TIMERx as defined in Appendix 4 hereinafter
attached.
ARTICLE 3: EXCLUSIVITY
SYNTHELABO understands and agrees that a consistent source of the TIMERx from a
supplier with the know-how and rights to make it is essential to the successful
production of the PRODUCT, and accordingly SYNTHELABO agrees to obtain all of
its and its Subsidiaries' requirements of supplies of the TIMERx from PPC
exclusively throughout the duration of this Agreement, except only as provided
in Clause 14.2 below and in Section 2)B) of the License Agreement.
ARTICLE 4: QUANTITIES - PLANNING
At least [**] before the end of each year, SYNTHELABO shall communicate to PPC
its annual forecasts for each of the [**].
ARTICLE 5: FORECASTS AND ORDERS
5.1 At least [**] before the end of each year, SYNTHELABO shall confirm the
forecast for the following year, such forecast being calculated, and being
shown to be calculated, on a month-by-month basis.
On the 10th of each month M, SYNTHELABO shall place with PPC its firm
orders for the month [**].
The minimum quantities of each TIMERx to be ordered on each occasion are
set out in Appendix 2 hereinafter.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
5.2 A firm order will be considered to have been accepted by PPC unless it
informs SYNTHELABO by courier, [**] of SYNTHELABO's order, of a change in
the delivery dates. Saturdays and Sundays are excluded in calculating this
[**] period.
5.3 While this Agreement remains in force, all orders for the months [**] and
all [**], shall correspond to delivery obligations for PPC and removal
obligations for SYNTHELABO.
ARTICLE 6: SUPPLY AND CONTROL
All the raw materials, packaging materials and packaging necessary for PPC to
manufacture the TIMERx will be supplied, controlled and identified (according to
Appendix 4) by PPC at its facilities in the course of its activities in
connection with this Agreement.
ARTICLE 7: STOCK
The raw materials and packaging materials shall be stored by PPC under its sole
responsibility, prior to delivery of the final PRODUCT.
PPC is also solely responsible for the safe storage of the TIMERx prior to
delivery of the final PRODUCT.
PPC therefore commits itself to storing in appropriate conditions the raw
materials, packaging materials and TIMERx, taking all necessary precautions to
ensure that the same do not suffer any damage, disintegration or alteration, in
accordance with Good Manufacturing Practices and the European Guide.
ARTICLE 8: MANUFACTURING AND TIMERx QUALITY
8.1 PPC or its contractor will manufacture and package the TIMERx in the
factory of Boehringer Ingelheim in Ridgefield, Connecticut, USA. No change
in the manufacturing factory will take place without written notice to
SYNTHELABO by PPC.
8.2 PPC undertakes to manufacture and package the TIMERx according to the PPC
MANUFACTURING TECHNOLOGY and the applicable specifications.
PPC undertakes to control raw materials, packaging materials and TIMERx
according to the techniques and instructions for analysis in accordance
with the specifications.
PPC shall follow the current Good Manufacturing Practices in effect in the
U.S. and the European Guide, especially the chapter 7 of this Guide.
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PPC hereby warrants that the TIMERx sold or to be sold to SYNTHELABO
hereunder will meet, at the time of shipment and receipt by SYNTHELABO
thereof, the specifications attached hereto in Appendix 1 and incorporated
herein by this reference. PPC also warrants that (i) it will, at the time
of shipment and receipt thereof, have a good and marketable (subject,
however, to SYNTHELABO's obtaining any required health or other
governmental regulatory licenses or permissions) title to the TIMERx sold
to SYNTHELABO and (ii) all TIMERx sold hereunder shall, on the date of
shipment and receipt, not be adulterated or misbranded within the meaning
of the United States Federal Food, Drug and Cosmetic Act, as amended from
time to time, and not be an article which may not, under the provisions of
Section 404 or 505 of the said act, be introduced into interstate commerce.
All sales of TIMERx shall be F.O.B. Patterson, New York (Incoterms 1990).
8.3 SYNTHELABO or its representative (expressly designated by SYNTHELABO) has
the right to verify at any time that the manufacture of the TIMERx is being
carried out in the proper manner in accordance with GMP and the European
Guide, but shall not, in doing so, have any right to view or learn any
confidential portions of the PPC MANUFACTURING TECHNOLOGY (unless and until
Section 2)B) of the License Agreement becomes effective). To this end, PPC
agrees to allow SYNTHELABO or such designate to have access to the
manufacturing and control areas, to take samples and in general to inspect
the relevant manufacturing operations, no more often than once every year
(unless more frequent visits are required due to persistent quality
problems), and upon at least 90 days' prior written notice to PPC.
PPC shall allow personnel from SYNTHELABO's Department of Quality Assurance
to investigate PPC's production unit and control laboratory no more often
than once every year (unless more frequent visits are required due to
persistent quality problems), and provided that SYNTHELABO gives at least
90 days' advance written warning.
8.4 A Quality Agreement: SYNTHELABO may request PPC to sign a Quality Charter
and PPC shall not unreasonably refuse to sign.
8.5 PPC shall provide SYNTHELABO for each lot of TIMERx with the documents and
samples specified in Appendix 4.
SYNTHELABO reserves the right to reject any batch which does not conform to
the corresponding specifications in Appendix 1 or Appendix 4. In this
event, provided it has SYNTHELABO's written approval, PPC can then recover
at PPC's expense the relevant raw materials, packaging materials and added
value.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SYNTHELABO will be considered to have accepted without reserve a given
batch if it has made no written objection [**] of the batch being delivered
by PPC.
8.6 In the event of the parties agreeing in writing that a batch does not
conform to the specifications, PPC shall at its own expense, [**] days
thereafter, either replace the relevant batch or use the recovered
materials to manufacture a replacement batch (as provided for in Article
8.5 above).
8.7 In the event of a dispute as to the acceptance of a batch, the parties
agree to discuss the problem with a view to finding an amicable solution.
To the extent that the dispute cannot be resolved amicably, the issue shall
be referred to an independent expert nominated by one party and to whom the
other party does not object.
If the parties are not able to agree on an expert within two (2) months of
a party's objection, an independent expert will be appointed under the
rules the London Court of Commercial Arbitration after request by one of
the parties.
The expert so appointed will determine whether or not the TIMERx concerned
conforms with the specifications (including without limitation the
applicable procedures for analytical control as set forth in the
specifications) and the other requirements set forth or referred to in this
Agreement, and whether the manufacturing conditions have been properly
followed, having particular regard to the file provided by PPC for each
TIMERx batch number.
The parties agree here and now to accept whatever conclusion is reached by
the expert. If the expert considers the TIMERx to be clearly defective, all
his fees and expenses will be paid for by PPC, which party shall also be
bound to reimburse whatever sums SYNTHELABO has already paid for the
defective batch.
If the expert considers the TIMERx to the clearly not defective, all his
fees and expenses will be paid for by SYNTHELABO.
The party taking in charge the destruction of the TIMERx will send to the
other party a certificate of destruction with the following:
o name of the TIMERx
o batch number
o quantity
o name of the company who has destroyed the TIMERx.
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8.8 PPC shall defend, indemnify and hold SYNTHELABO harmless from and against
all financial liability arising from any claim or action brought against
SYNTHELABO by a third party for personal harm resulting from a defect in
the TIMERx that causes it to be out of conformity with the applicable
specifications; provided that SYNTHELABO shall provide PPC with written
notice of any claim or action within ten (10) days of its receipt thereof,
and shall afford PPC the right to control the defense and settlement of
such claim or action. Additionally, SYNTHELABO shall provide reasonable
assistance to PPC in the defense of such claim or action.
8.9 Nevertheless, PPC declines all responsibility arising from the use of the
TIMERx otherwise than in accordance with the specifications of the Quality
Charter, and shall not be liable for any claim, loss or damage whatsoever
arising from such use. SYNTHELABO shall provide to PPC and its suppliers
defense and indemnity, on terms similar to those in Clause 8.8, for all
financial liability arising from any claim or action brought against PPC or
such suppliers by a third party resulting from any aspect of the PRODUCT or
its marketing or use that is not due to a defect in the TIMERx that causes
it to be out of conformity with the applicable specifications.
8.10 Each party shall take out insurance in accordance with industry standards
to cover all such risks and shall at the other party's request communicate
the details of such insurance coverage to such other party.
ARTICLE 9: DELIVERY CONDITIONS
9.1 TIMERx shall be delivered FOB Patterson N.Y., and SYNTHELABO shall arrange
for shipment at its risk and expense.
9.2 PPC will deliver the TIMERx packaged and labeled in accordance with
Appendix 4. Each delivery must be accompanied by the documents listed in
Appendix 4. It is agreed that the ownership of the TIMERx passes upon
delivery at the FOB point.
ARTICLE 10: PRICE
The sale price of the TIMERx, conditions of payment and formula for revision of
the price are defined in Appendix 3 hereafter.
ARTICLE 11: PERSONNEL FEES AND EXPENSES
If at any time and for any reason any personnel of PPC or any contractors to PPC
are requested by SYNTHELABO or LEIRAS to travel outside the area of Patterson,
N.Y. in whole or in part for the benefit of SYNTHELABO, or to devote time in or
outside the Patterson area specifically to the needs of SYNTHELABO or to any
technology transfers called for hereunder, SYNTHELABO shall pay, or shall cause
LEIRAS to pay, PPC for all reasonable expenses associated with such travel, plus
a per diem fee equal to PPC's then-current charges for such personnel.
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ARTICLE 12: REGULATORY COMPLIANCE
12.1 Each party agrees to make to the relevant Authorities such declarations as
are necessary to comply with pharmaceutical law, it being understood and
agreed that obtaining and maintaining all HEALTH REGISTRATION shall be the
responsibility of SYNTHELABO or LEIRAS, at its or their expense.
12.2. Any term of this Agreement that does not comply with the law regulating
the pharmaceutical profession must be modified accordingly within the
shortest possible time.
ARTICLE 13: TERM
13.1 This Agreement shall commence with effect from the date hereof and, unless
terminated earlier pursuant to Clause 13.2 or 14, shall continue until the
last effective and enforceable date of any of the patents listed in
Appendix 5 hereinafter attached which the parties anticipate will be March
4, 2014; provided, however, that this Agreement will in any event
terminate, on a nation by nation basis, upon the termination or expiration
of the License Agreement, if it has not already done so.
13.2 If one party (hereinafter called "the Defaulting Party"):
13.2.1. is in the material breach of its obligations under this Agreement,
or
13.2.2. becomes insolvent or enters into liquidation (other than as a party
of a scheme for solvent reconstruction or amalgamation) or makes
assignment for the benefit of its creditors generally or has a
receiver or administrative receiver appointed of all or any of its
assets or if any event analogous to the foregoing shall occur of
the Defaulting Party in any jurisdiction where that party is
resident or carries on business, or
13.2.3. is unable by reason of the events and circumstances referred to in
Clause 8 to perform its obligations hereunder for a continuous
period of six (6) months,
the other party may at any time thereafter by notice in writing to the
Defaulting Party require the Defaulting Party to withdraw from this
Agreement provided that, in the case of breach capable of remedy, the
Defaulting Party shall have sixty (60) days from the date of such notice to
remedy the breach and, if the breach is remedied within such period, the
notice shall not take effect.
ARTICLE 14: TERMINATION
14.1 In the event of one of the parties being in breach of this Agreement, the
non-defaulting party may give notice to the Defaulting Party of the breach
and indicate its
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intention to terminate the Agreement if the breach is not remedied within
sixty (60) days of the notice.
14.2 SYNTHELABO may terminate the Agreement and cause Section 2)B) of the
License Agreement to become applicable, as provided in such Section 2)B),
in the following circumstances:
a) PPC is prevented from providing the TIMERx to PPC by reason of legal,
administrative, regulatory or judicial decision lasting for more than
60 days,
c) repeated failure of PPC to meet the delivery dates such that PPC
fails, over a continuing period of sixty days, to supply SYNTHELABO
with its and its Subsidiaries' requirements of TIMERx, or
d) the quality of the TIMERx provided by PPC is persistently out of
conformance with the specifications, such that PPC fails, over a
continuing period of sixty days, to supply SYNTHELABO with its and its
Subsidiaries' requirements of TIMERx.
14.3 Termination of this Agreement in accordance with this article will not give
either party the right to any indemnity whatsoever from the other.
ARTICLE 15: FORCE MAJEURE
15.1 The term "Force Majeure" is understood to mean all acts or events that are
unforeseeable and unavoidable, or simply unavoidable, such as natural
disasters, fires, floods, explosions, riots, wars, emergency restrictions
imposed by military or civil authorities, strikes and lock-outs, shortages,
and in general, any circumstance which is beyond the control of the parties
and renders impossible the execution of this Agreement.
15.2 If either party is unable to perform this Agreement by reason of force
majeure, it shall notify the other party as soon as it becomes aware of the
act or event resulting of a force majeure, and in any event no later than
48 hours from such act or event.
15.3 The non-performing party must employ all its efforts to overcome its
default of performance and to assume its obligations under this Agreement
as quick as possible. Nevertheless, neither party should employ methods it
deems inappropriate in order to avoid or to end a strike.
15.4 No indemnity will be payable by one party to the other as a result of
non-performance due to force majeure.
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ARTICLE 16: ASSIGNMENT AND TRANSFER
This Agreement may not be assigned or transferred, in total or in part, by
either party without the prior written consent of the other. It is understood
that SYNTHELABO will assign its rights hereunder to one or more of its
Subsidiaries that own and operate approved and certified manufacturing
facilities in the TERRITORY. PPC will not unreasonably withhold its consent to
such assignments to such qualified Subsidiaries. It is also understood and
agreed that PPC shall have the right to assign or transfer this Agreement to any
of its affiliates or in connection with any sale of all or substantially all
assets of PPC related to the TIMERx Controlled Release System.
ARTICLE 17: JURISDICTION
This Agreement shall be governed by and interpreted in accordance with English
Law. All disputes, controversies, or differences which may arise between the
parties, out of or in relation to or in connection with this Agreement or any
breach thereof shall be finally settled by arbitration held in London pursuant
to the then obtaining Rules of the London Court of International Arbitration, by
which each party hereto agrees to be bound. The arbitration language shall be
English.
ARTICLE 18: NOTICES
18.1 Any notice to be given under this Agreement shall be in writing in English
and shall be deemed duly given if signed by or on behalf of a duly
authorized office of the party giving the notice and if left at or sent by
registered or recorded delivery post or by telex, telegram, facsimile
transmission or other means of telecommunication in permanent written form
to the address of the party set out above or such other address as either
party may from time to time notify to the other. Any such notice or other
communication shall be deemed to be given:
o at the time when the same is handed to or left at the address of the
party to be served,
o by post on the day (not being a Sunday or public holiday) five (5) days
following the day of posting,
o in the case of a telegram, telex or facsimile transmission in the next
following day.
18.2 Notices shall be addressed to the parties under their above-mentioned
addresses.
18.3 In proving the giving of notice, it shall be sufficient to prove that the
notice was left or that the envelope containing the notice was properly
addressed and dispatched (as the case may be).
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ARTICLE 19: NO IMPLIED WAIVER
A waiver by either party of any right under this Agreement in any one instance
shall not be deemed or construed to be a waiver of such right for any similar
instance in the future or of any subsequent breach hereof, nor shall it prevent
a subsequent enforcement of that right.
ARTICLE 20: SEVERABILITY
If any provision(s) of this Agreement are or become invalid, or are ruled
illegal or are deemed unenforceable under the current applicable law from time
to time in effect during the term hereof, it is the intention of the parties
that the remainder of this Agreement shall not be affected thereby. It is
further the intention of the parties that in lieu of each such provision which
is invalid, illegal or unenforceable, there will be substituted or added as part
of this Agreement a provision which shall be as similar as possible in
objectives as intended by the parties.
ARTICLE 21: SOLE UNDERSTANDING
No representations, warranties, conditions or other statements not contained
herein or in the License Agreement shall be binding on the parties hereto, and
no variation of the terms hereof shall be binding on the parties, unless made in
writing by the authorized representatives of the parties.
ARTICLE 22: PARTNERSHIP
Nothing in this Agreement shall constitute a partnership between the parties
hereto.
ARTICLE 23: HEADINGS
The Headings of Clauses shall not affect their interpretation.
ARTICLE 24: EXECUTION IN COUNTERPARTS
This Agreement shall be executed in two (2) counterparts, both of which shall be
considered one and same agreement and shall become a binding agreement when the
two (2) counterparts have been signed by authorized representatives of the
parties and delivered to the other party.
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IN WITNESS WHEREOF, the parties have cause this Agreement to be executed by
their duly authorized officers.
Made at
on
in two originals
SYNTHELABO GROUPE PENWEST PHARMACEUTICALS CO.
By /s/ Xxxx Xxx, Xx. By /s/ Xxxx X. Xxxxxx
--------------------------------- ---------------------------
Title VP Synthelabo Title President
------------------------------ ------------------------
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SUPPLY AGREEMENT
----------------
BETWEEN SYNTHELABO AND PPC
APPENDIX 1
----------
PRODUCT SPECIFICATIONS
(This will include the specifications of TIMERx that were sent to Synthelabo.)
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUPPLY AGREEMENT
----------------
BETWEEN SYNTHELABO AND PPC
APPENDIX 2
----------
MINIMUM ORDER SIZE:
-------------------
[**]
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
SUPPLY AGREEMENT
BETWEEN SYNTHELABO AND PPC
APPENDIX 3
PRICES AND REVISION OF PRICES
1) Except as provided in Section 2)B) of the License Agreement, SYNTHELABO
shall purchase directly from PPC all of its and its Subsidiaries'
requirements of TIMERx for the Product's manufacture, use or sale in the
Territory and PPC shall sell SYNTHELABO all of SYNTHELABO's and its
Subsidiaries' requirements of TIMERx for the said purpose. The price to be
charged by TIMERx to SYNTHELABO in fulfillment of such requirements shall
be USD [**], subject to increase [**]. Any price revision in excess of the
annual change in the US Pharmaceutical Producers Index, as published by the
US Bureau of Labor Statistics, will not be instituted unless the parties
have discussed the reasons and need for such increase and SYNTHELABO has
consented thereto, which consent will not be withheld unreasonably.
All monies due to PPC under this Agreement shall be paid in United States
Dollars to PPC in Patterson, New York, USA. The exchange rate between the
French franc and the US dollar is fixed by the parties at the effective
date of this Agreement at [**] French francs to one (1) US dollar. If at
any time during the term of this Agreement the value of the French franc
depreciates or appreciates, in comparison to the exchange rate fixed above,
by more than [**] and sustains that level for at least [**] days, the
parties will meet to renegotiate price terms acceptable to both parties, in
an attempt to agree on a price in USD whereby the parties will equally
share the burdens and benefits of the portion of such fluctuation in the
exchange rate in excess of [**]. If the value of the French franc
depreciates or appreciates by more than [**], and sustains that level for
at least [**] an adjustment will be made to the price in USD to reflect
that portion of such depreciation or appreciation that is in excess of
[**]. No adjustments will be made for fluctuations in the value of the
French franc of [**] or less, up or down, from the exchange rate fixed at
the effective date. This paragraph will be reviewed by the parties and
revised to the extent necessary to reflect the adoption by the European
Union (with France's participation) of the Euro currency.
2) Payment shall be made by SYNTHELABO within sixty (60) days of receipt of
the goods, unless otherwise agreed between the parties by bank transfer.
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SUPPLY AGREEMENT
----------------
BETWEEN SYNTHELABO AND PPC
APPENDIX 4
----------
TECHNICAL FILE
--------------
[List packaging and storage specifications and required documentation and
samples to be submitted with each delivered batch.]
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 5
PPC PATENT RIGHTS
To the Agreement between SYNTHELABO and PPC of December 17, 1997.
LIST OF PATENT AND PATENT APPLICATIONS COVERING TIMERx
1) US Patent No. 4,994,276, entitled "Directly Compressible Sustained Release
Excipient," issued February 19, 1991.
2) US Patent No. 5,128,143, entitled "Sustained Release Excipient and Tablet
Formulation," issued July 7, 1992.
3) US Patent No. 5,135,757, entitled "Compressible Sustained Release Solid
Dosage Forms," issued August 4, 1992.
4) European Patent Application, Publication No. 0360562 entitled "Directly
Compressible Sustained Release Excipient," filed Sept. 19, 1989, issued
July 28, 1993 as Pub. No. 0360562B1.
5) [**]
6) US Patent Application Serial No. 08,206,416, filed March 4, 1994, issued as
US Patent No. 5,399,359 on March 21, 1995, "CONTROLLED RELEASE OXYBUTYNIN
FORMULATIONS."
7) [**]
8) Ireland, IE, Publication No. 65170.
9) Xxxxxxx, XX, Xxxxxxxxxxx Xx. 00000.
10) Finland, FI, Publication No. 9505215.
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