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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
LICENSE AGREEMENT
This Agreement is dated the 17th day of December, 1997, and is made between
SYNTHELABO
22, Avenue Galilee
▇-▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇
Facsimile: _______________________
Attention: _______________________
(hereinafter called SYNTHELABO)
AND
PENWEST PHARMACEUTICALS CO.
▇▇▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇▇▇
▇.▇.▇.
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: _______________________
(hereinafter called PPC)
WHEREAS
A) PPC is the owner of TIMERx Controlled Release System and certain
patents pertaining thereto;
B) ▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇-▇▇, ▇▇▇▇▇ ▇▇▇▇▇ - ▇▇▇▇▇▇▇ (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;
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;
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D) SYNTHELABO has evaluated the said Controlled Release System and
has determined its interest to use it for manufacturing and
marketing the PRODUCT in certain territories;
E) PPC and LEIRAS have agreed that PPC shall grant certain licenses
to SYNTHELABO regarding the manufacture and marketing of the
PRODUCT in the TERRITORY stated herein. PPC and SYNTHELABO have,
concurrently with this Agreement entered into a Supply Agreement
regarding the sale by PPC to SYNTHELABO of the TIMERx required
for the production of the PRODUCT by SYNTHELABO (the "Supply
Agreement");
F) PPC and SYNTHELABO have agreed to enter into a License Agreement
for the said Controlled Release System and related PATENT RIGHTS;
NOW THEREFORE, in consideration of the premises and mutual covenants herein
contained, the parties hereto agree as follows:
1. DEFINITIONS
a) COMPOUND shall mean the bulk pharmaceutical compound known as
Oxybutynin and its pharmaceutically acceptable salts, enantiomers and
active metabolites;
b) PRODUCT shall mean the pharmaceutical dosage form containing 10mg of
COMPOUND; and corresponding with the specifications as defined in
ANNEX A attached hereto;
c) PATENT RIGHTS shall mean the different PATENTS and PATENT APPLICATIONS
covering TIMERx as more closely defined in ANNEX B attached hereto;
d) TERRITORY shall mean the nations listed in ANNEX C attached hereto;
e) PPC MANUFACTURING TECHNOLOGY means all required know-how, methods,
processes, techniques, trade secrets, specifications, technological
information and other data associated with PATENT RIGHTS and relating
to the manufacture and use of TIMERx Controlled Release System;
f) IMPROVEMENTS shall mean any additions to or modifications of PPC
MANUFACTURING TECHNOLOGY or the subject matter of PATENT RIGHTS,
whether patentable or unpatentable, made or acquired by either party
hereto which such party is free to use and disclose during the term of
this Agreement that are useful in the formulation and manufacture of
PRODUCT;
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
g) NET SALES shall mean the [**];
h) 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;
i) HEALTH REGISTRATION shall mean approval by all relevant regulatory
authorities in each nation in the TERRITORY for commercial sale of the
PRODUCT for administration in humans, pursuant to a product license
application or other applicable submissions submitted by or for
SYNTHELABO and/or LEIRAS.
2) GRANT OF LICENSE
A) Subject to the terms and conditions of this Agreement, PPC hereby
grants to SYNTHELABO and SYNTHELABO accepts an exclusive license to
use PATENT RIGHTS and PPC MANUFACTURING TECHNOLOGY for manufacturing,
promoting and selling the PRODUCT in the TERRITORY, provided however
that SYNTHELABO may freely grant sublicenses of such rights to its
Subsidiaries in the TERRITORY, it being understood that the present
license is also exclusive towards PPC or PPC's Subsidiaries, if any;
and provided further, however, that this license does not grant to
SYNTHELABO or its Subsidiaries any right to manufacture the TIMERx to
be used by SYNTHELABO in the manufacture of the PRODUCT unless and
until the contingent license in Section 2)B) becomes applicable in the
circumstances and during the period there described. 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 agrees to
purchase all of its Subsidiaries' requirements of TIMERx from PPC
under the Supply Agreement during the term hereof, except only as
provided in Section 2)B). SYNTHELABO may, on a temporary basis
immediately following the Effective Date while SYNTHELABO is bringing
its own manufacturing capability into operation, contract with LEIRAS
for the manufacture by LEIRAS of the PRODUCT in LEIRAS's approved
facilities solely for sale to SYNTHELABO for resale under this License
Agreement; provided that this interim manufacturing shall be
considered to be performed by LEIRAS as a subcontractor/sublicensee to
SYNTHELABO. Accordingly, SYNTHELABO shall supply to LEIRAS all of the
TIMERx to be used in such manufacturing from the supplies to be
purchased by SYNTHELABO from PPC under the Supply Agreement.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
B) If for any reason PPC fails, over a continuing period of [**] to
supply SYNTHELABO with its and its Subsidiaries' requirements of
TIMERx, PPC shall, AS SYNTHELABO'S SOLE AND EXCLUSIVE REMEDY FOR ANY
FAILURE TO SUPPLY TIMERx, grant SYNTHELABO a nonexclusive license to
manufacture TIMERx under the PPC Manufacturing Technology and make
knowledgeable personnel reasonably available, at SYNTHELABO'S expense
(as provided in Section 3)C)), to consult with SYNTHELABO, all to the
extent necessary to enable SYNTHELABO or its qualified Subsidiary to
produce TIMERx that would otherwise have been supplied by PPC under
the Supply Agreement for SYNTHELABO and its Subsidiaries in connection
with the production of the PRODUCT pursuant to this Agreement.
SYNTHELABO will be responsible for maintaining an inventory of TIMERx
sufficient to cover any delivery failures shorter than [**] in
duration. SYNTHELABO shall maintain PPC Manufacturing Technology
delivered to SYNTHELABO pursuant to this section, whether orally or in
writing, in strictest confidence and shall use such information and
technology only for the purpose of producing TIMERx for its own use
and the use of its Subsidiaries in connection with this Agreement and
within the scope of the license granted hereunder. SYNTHELABO
acknowledges that, in doing the foregoing, PPC will not be providing a
"turnkey" operation. Rather, PPC will only be required to make
reasonably available to SYNTHELABO the best standard of knowledge and
information then available to PPC and directly used in its or its
affiliates' or contractors' manufacture of TIMERx. In such event
SYNTHELABO shall pay to PPC US[**](or the then-current TIMERx price,
as such per-kilogram price may be adjusted over the life of the
Agreement in accordance with Appendix 3 to the Supply Agreement) per
kilogram of TIMERx produced and converted to PRODUCT by SYNTHELABO or
its Subsidiaries, less SYNTHELABO's or its relevant Subsidiary's
reasonable variable manufacturing costs including costs of materials
therefor. If PPC's non-delivery of the TIMERx resulted in whole or in
part from a temporary inability to produce and deliver the same, PPC
may, at its option and on at least 90 days' prior written notice to
SYNTHELABO, terminate the license to produce TIMERx hereunder and
reinstitute the Supply Agreement notwithstanding Clause 14.2 thereof,
once PPC or its alternative supplier, contractor or licensee is again
able and willing to supply TIMERx hereunder, during which 90-day
period SYNTHELABO will be entitled to exhaust its work in process and
any inventory of TIMERx.
3) DISCLOSURE OF PPC MANUFACTURING TECHNOLOGY
A) SYNTHELABO understands and agrees that no technology transfer or other
disclosures to SYNTHELABO will be required from PPC under this
Agreement, unless the circumstances described in Section 2)B) become
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applicable and lead to the disclosures there provided for, or unless
PPC otherwise agrees in writing, and at its discretion.
B) SYNTHELABO shall treat and cause SYNTHELABO's Subsidiaries to treat
any and all PPC MANUFACTURING TECHNOLOGY and other information
received from PPC in connection with this Agreement (including all PPC
MANUFACTURING TECHNOLOGY and other information disclosed by PPC before
the execution of this Agreement) as confidential and not to be
disclosed to any other person, company or firm (except to the
competent authorities on a confidential basis as required in order to
obtain the HEALTH REGISTRATION, and except as far as necessary on a
confidential basis for carrying out pre-clinical and clinical trials),
except the following information:
a) information which at the time of disclosure by PPC is part of the
public knowledge;
b) information which after disclosure by PPC becomes part of the
public knowledge by publication or otherwise, except by breach of
this Agreement by SYNTHELABO or SYNTHELABO's Subsidiaries;
c) information which SYNTHELABO or SYNTHELABO's Subsidiaries can
establish by competent proof was in its possession at the time of
disclosure by PPC and was not acquired directly or indirectly
from PPC under a secrecy obligation; or
d) information which SYNTHELABO or SYNTHELABO's Subsidiaries
lawfully receive from a third party; provided, however, that such
information was not obtained by said third party directly or
indirectly from PPC under a secrecy obligation.
The obligations of confidentiality, non-use and non-disclosure of PPC
MANUFACTURING TECHNOLOGY and other information under this Agreement
shall expire five (5) years after expiration of the last-to-expire of
PATENT RIGHTS or fifteen (15) years after the date of this Agreement,
whichever occurs later.
C) 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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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
4) REPORTS
SYNTHELABO shall promptly render to PPC the following reports:
A) Quarterly reports on gross sales amount and NET SALES of PRODUCT in
terms of units and value, and the amount of samples distributed.
B) Quarterly reports on the quantity of PRODUCT held by SYNTHELABO's
Subsidiaries in inventory on hand.
C) Reports on the selling prices of PRODUCT in TERRITORY as they are
fixed or modified.
5) ROYALTY
A) In consideration of the license granted, the disclosure made and the
obligations undertaken by PPC under this Agreement, SYNTHELABO shall
pay to PPC or its nominee a Running Royalty at the rate of [**] based
on the NET SALES of PRODUCT sold by SYNTHELABO or SYNTHELABO's
Subsidiaries whether or not in a nation in which there are any
then-subsisting PATENT RIGHTS. Payments of the Running Royalty shall
be made within thirty (30) days after the end of each calendar quarter
expiring March 31, June 30, September 30 and December 31 for the
Running Royalty accruing during such calendar quarter.
B) All taxes levied on the income of PPC or its nominee arising from the
effect of this Agreement, including any withholding taxes on
royalties, shall be borne by PPC or its nominee, and SYNTHELABO or its
Subsidiaries shall secure proof of the payment thereof out of the
royalty, and shall deliver such proof to PPC.
C) All monies due to PPC under this Agreement shall be paid in United
States Dollars to PPC in Patterson, New York, USA. The rate of
exchange to be used shall be the average commercial rate of exchange
for the 30 days preceding the date of payment for the conversion of
local currency to United States Dollars as published by The Wall
Street Journal (or if it ceases to be published, a comparable
publication to be agreed upon by the parties) or, for those countries
for which such average exchange rate is not published by The Wall
Street Journal, the exchange rate fixed on the fifth day prior to the
date of payment as promulgated by the appropriate United States
governmental agency as mutually agreed upon by the parties.
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6) ACCOUNTING AND INSPECTION
SYNTHELABO shall keep, or cause to be kept, records of the sale of PRODUCT
under this Agreement. Such records shall be open to inspection, at any
reasonable time within three (3) years after the expiration of each
calendar quarter, by an independent certified public accountant retained
and paid by PPC and only rejectionable by SYNTHELABO or SYNTHELABO's
Subsidiaries for good cause, who shall report only the amount of NET SALES.
Any objection to the accuracy or completeness of the described statement or
the amount shall be filed in writing by PPC within said three (3) year
period, or such statement and amount shall be deemed true and correct as
between the parties hereto.
7) IMPROVEMENTS
If the license described in Section 2)B) becomes applicable under the
circumstances there described, such license will also cover rights in any
IMPROVEMENTS prior to that time incorporated by PPC into its manufacture of
the TIMERx for supply to SYNTHELABO under the Supply Agreement. Otherwise,
PPC shall not be required to license or to disclose to SYNTHELABO any of
its IMPROVEMENTS, except that: (i) the license under Section 2 shall
include rights in any after-acquired patents in the TERRITORY insofar as
the substance Oxybutynin in combination with TIMERx is concerned, and (ii)
if PPC should during the term of this Agreement undertake any further
development program specifically for and directed at improving the PRODUCT
in its specific formulation and dosage strength (but not including any
other programs or discoveries, even if the same could be useful for the
PRODUCT), it will, to the extent it may do so without breaching any
third-party rights or agreements or requiring any third-party royalties or
other payments, disclose to SYNTHELABO any useful IMPROVEMENTS discovered
by PPC in the course of such program and include the same under the
licenses of Section 2, provided, however, that (A) such IMPROVEMENTS will
only be those that do not require a recertification of the PRODUCT by any
governmental agency and (B) such license and disclosure shall, as to
IMPROVEMENTS to PPC MANUFACTURING TECHNOLOGY, be subject to the same
conditions and circumstances as to use and disclosure as set out in Section
2 for the other PPC MANUFACTURING TECHNOLOGY. If SYNTHELABO or its
Subsidiaries should during the term of this Agreement undertake any further
development program specifically for and directed at improving the PRODUCT
in its specific formulation and dosage strength (but not including any
other programs or discoveries, even if the same could be useful for the
PRODUCT), it and they will, to the extent it or they may do so without
breaching any third-party rights or agreements or requiring any third-party
royalties or other payments, disclose to PPC any useful IMPROVEMENTS
discovered in the course of such program, and shall give to PPC and its
affiliates and licensees the nonexclusive right to use any such IMPROVEMENT
free of any royalty or other compensation on any non-patentable or
patentable IMPROVEMENT.
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8) PATENTS
A) PPC agrees to be responsible for paying renewal fees to maintain the
PATENT RIGHTS in the TERRITORY.
B) PPC declares that at the date of execution of this Agreement and to
the best of its knowledge, with the exception of the pending challenge
to the PATENT RIGHTS brought by the Boots Company, there is no action
threatened or pending against PATENT RIGHTS.
C) Each party shall inform the other of any infringement and threatened
infringement by a third party of the PATENT RIGHTS in the TERRITORY.
In the event of such infringement, PPC will have the right to
institute proceedings against such infringer by any and all means
which PPC will find suitable for such purpose. Should PPC decide, at
its sole discretion, to institute legal proceedings against such
infringer, PPC shall have the right to select its own attorneys and
shall assume payment of all fees or costs in respect of such legal
proceedings or as much as it is necessary up to the conclusion of the
action or its various settlement or discharge as well as of all
damages, including interest, if awarded to the defending party, and
shall, if awarded to PPC, retain all profits, damages and other
recovery.
If PPC does not institute legal proceedings against such infringer
within 90 days of SYNTHELABO's request to do so, and if and to the
extent that such infringement involves a product with the active
ingredient Oxybutynin in the TERRITORY, SYNTHELABO or SYNTHELABO's
Subsidiaries will have the right to institute such proceedings at its
own cost and expenses. In such event, all damages, including interest,
if awarded to the defending party, shall be borne by SYNTHELABO or
SYNTHELABO's Subsidiaries and shall, if awarded to SYNTHELABO or
SYNTHELABO's Subsidiaries, be retained by it or them.
D) If SYNTHELABO or SYNTHELABO's Subsidiaries or PPC, by reason of its
exercise of the rights granted by PPC with respect to PATENT RIGHTS
and PPC MANUFACTURING TECHNOLOGY (but not to the extent by reason of
any other technology or rights, such as any rights derived from LEIRAS
or with respect to aspects of the PRODUCT contributed by LEIRAS or
SYNTHELABO), is informed or sued for alleged infringement of the
intellectual property or other proprietary rights vested in a third
party and relating to the PRODUCT, other than by the Boots Company
within the scope of its claims made in its pending challenge to the
PATENT RIGHTS, the party concerned shall give prompt notice of such
suit or information to the other party and PPC shall defend or settle
such suit with attorneys of its own choice and at its own cost.
SYNTHELABO or SYNTHELABO's Subsidiaries shall render PPC all necessary
assistance in defending such suit.
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All costs and damages awarded against SYNTHELABO or SYNTHELABO's
Subsidiaries in such a suit, excluding, however, any costs or losses
sustained by SYNTHELABO or SYNTHELABO's Subsidiaries in respect of
loss of revenue from sales of PRODUCT or abortive production costs,
shall be paid by PPC, provided that SYNTHELABO or SYNTHELABO's
Subsidiaries shall have given prompt notice in writing to PPC of any
claim of such alleged infringement as well as the bringing or the
threat of such bringing of any suit. SYNTHELABO or SYNTHELABO's
Subsidiaries shall permit PPC by counsel of PPC's choice to defend or
settle the claim or suit, and SYNTHELABO or SYNTHELABO's Subsidiaries
shall not defend or settle any such claim without prior written
consent of PPC.
SYNTHELABO shall provide to PPC and its suppliers similar defense and
indemnity for costs and damages if PPC or such suppliers are informed
or sued for alleged infringement of the intellectual property or other
proprietary rights vested in a third party (including without
limitation the Boots Company) and relating to the PRODUCT with respect
any other technology or rights, such as any rights derived from LEIRAS
or with respect to aspects of the PRODUCT contributed by LEIRAS or
SYNTHELABO.
E) The above referred obligations with respect to PATENT RIGHTS shall be
relinquished on the date of expiration of the last PATENT RIGHTS in
the TERRITORY, except pending cases or cases referring to the time
prior to the expiration of the PATENT RIGHTS.
9) TERM AND TERMINATION
A) The term of this Agreement, as it applies to any nation in the
European Union, shall be until the expiration of the last-to-expire of
the PATENT RIGHTS in that nation. In all nations not members of the
European Union, the term of this Agreement shall be until the
expiration of the last-to-expire of all of the PATENT RIGHTS in all
nations in the TERRITORY (including those in the European Union),
whether or not the PATENT RIGHTS in one or more (but less than all) of
such nations may have previously expired; provided, however, that this
Agreement will in any event terminate upon the termination or
expiration of the Supply Agreement, if it has not already done so,
except for a termination referred to in Section 14.2 of the Supply
Agreement, in which event this License Agreement will continue and the
terms of Section 2)B) will be applicable.
The term "expiration" of the Agreement as used in this Agreement shall
mean the end of the above-defined term of this Agreement only pursuant
to this Section 9-A.
B) Without prejudice to any remedy or claims it may have against the
other party for breach or non-performance of this Agreement, either
party shall be entitled
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to immediately terminate this Agreement by written notice if the other
party should violate any of the provisions or conditions of this
Agreement and if after having been given a written warning the other
party should fail to discontinue or should fail to make good such
violation within sixty (60) days after receipt of the warning.
C) In the event of insolvency, bankruptcy, liquidation or dissolution of
SYNTHELABO or appointment of a trustee or receiver for it, it shall
immediately notify PPC to that effect. In any such event, PPC so
notified shall have the right to terminate this Agreement at any time.
D) In the event of insolvency, bankruptcy, liquidation or dissolution of
PPC, the validity as well as the duration of the present contract
shall not be affected.
10) CONSEQUENCES OF TERMINATION
Upon termination by either party of this Agreement the rights and
obligations of such party shall cease with effect from the date of
termination save for confidentiality obligations and the obligation to pay
accrued royalties, all of which shall remain in full force and effect
provided that the termination by either party of this Agreement shall be
without prejudice to any accrued claims or rights of action that either
party may have against the other up to the date of such termination.
Following expiration of the full term of this Agreement in a nation or
nations, the license granted shall become non-exclusive and royalty-free in
that nation or those nations.
11) FORCE MAJEURE
If and to extent that either party is hindered or prevented by
circumstances not now foreseeable and not within its reasonable ability to
control from performing any of its obligations under this Agreement and
promptly so notifies the other party giving particulars of the
circumstances in question, then the party so affected shall be relieved of
liability to the other for failure to perform such obligations, but shall
nevertheless use all reasonable endeavours to resume full performance
thereof without avoidable delay.
12) NOTICES
12.1 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 officer of the party giving 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
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12.1.1 at the time when the same is handed to or left at the address
of the party to be served;
12.1.2 by post on the day (not being a Sunday or public holiday) five
(5) days following the day of posting; and
12.1.3 in the case of a telegram, telex or facsimile transmission on
the next following day.
12.2 Notices shall be addressed to the parties under their above-mentioned
addresses.
12.3 In proving the giving of a 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).
13) CHOICE OF LAW
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.
14) ASSIGNMENT
This Agreement may not be assigned or transferred by either party without
the prior written consent of the other. However, SYNTHELABO shall have the
right to assign or to transfer this Agreement or to grant a sub-license to
its Subsidiaries in the TERRITORY, and 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.
15) 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.
16) 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
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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 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.
17) SOLE UNDERSTANDING
No representations, warranties, conditions or other statements not
contained herein or in the Supply 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. This Agreement and the Supply Agreement and the documents referred
to herein together contain the entire agreement between the parties with
respect to their subject matter and supersede and replace all prior
agreements written or oral with respect thereto.
18) PARTNERSHIP
Nothing in this Agreement shall constitute a partnership between the
parties hereto.
19) HEADINGS
The Headings of Sections shall not affect their interpretation.
20) EXECUTION IN COUNTERPARTS
This Agreement shall be executed in two (2) counterparts both of which
shall be considered one and the 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.
IN WITNESS WHEREOF the parties have caused this Agreement to be executed by
their duly authorized officers.
SYNTHELABO PENWEST PHARMACEUTICALS CO.
By /s/▇▇▇▇ ▇▇▇, ▇▇. By /s/▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------ -----------------------------
Title VP Synthelabo Title President
--------------------------- ---------------------------
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ANNEX A
PRODUCT SPECIFICATIONS
[to be provided]
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ANNEX B
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) [**]
7) International (PCT) Patent Application No. PCT/US94/02926, filed March 18,
1994.
8) Ireland, IE, Publication No. 65170.
9) ▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇. ▇▇▇▇▇.
10) Finland, FI, Publication No. 9505215.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
ANNEX C
TERRITORY
[**]
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