1
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 10.8
LETTER OF CONSENT
The parties hereto have today agreed upon the following:
1. PARTIES
TIMERx TECHNOLOGIES
▇▇▇▇ ▇▇▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇▇▇-9970
U.S.A.
in the following TIMERx and
LEIRAS OY
Pansiontie 45-47
FIN-20210 Turku
Finland
in the following Leiras.
1. BACKGROUND
Leiras and TIMERx (formerly ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Co., Inc.) are parties to an
agreement dated July 27th, 1992 (in the following Agreement) and a
Letter of Agreement signed concurrently with this Letter of Consent,
concerning, in particular, Leiras' Cystrin (Oxybutynin) product and the
TIMERx Controlled Release System, and the utilization of a combination
or combinations thereof and/or of developments thereof. Leiras and
TIMERx have cooperated in the
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development and formulation of the Oxybutynin-TIMERx product, which
programme is now in its final stages. TIMERx has completed its portion
of the Development Programme, and any further development will be
conducted by ▇▇▇▇▇▇.
2. CONSENT TO DISCLOSURES
In connection with the commercial utilization of Cystrin (Oxybutynin)
worldwide, Leiras may wish to assign and transfer the product rights
pertaining thereto, inclusive of the TIMERx element and any
developments as foreseen or contemplated in the Agreement, in various
manners and in various territories. Prior to such potential assignments
and transfers, ▇▇▇▇▇▇ may have to disclose relevant and proprietary
information needed by the potential assignee/transferee for evaluation
purposes. Such disclosure may also comprise TIMERx elements and, as the
case may be, key portions of the Agreement. TIMERx hereby gives its
approval to such disclosures on the condition that the potential
assignee/transferee enters into a confidentiality agreement basically
in the form of Appendix A attached as a specimen hereto.
3. CONSENT TO ASSIGNMENTS AND TRANSFERS
Should ▇▇▇▇▇▇ agree with a potential assignee/transfer on the
assignment and transfer of the above-mentioned product rights as
foreseen as a possibility above, such assignment and transfer shall
take place on the terms and conditions of an agreement basically in the
form of Appendix B attached as a specimen hereto. ▇▇▇▇▇▇'s approval to
such assignment(s) and transfer(s) on such terms and conditions, shall
not be unreasonably withheld unless such assignment and transfer would
be seriously detrimental to the interests of TIMERx from an objective
point of view, taking also into consideration ▇▇▇▇▇▇' interest in such
an assignment and transfer. ▇▇▇▇▇▇'s approval may be withdrawn in the
thirty (30) day period following the receipt from Leiras of written
notification of the identity of the potential assignee/transferee.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
Notwithstanding anything to the contrary, TIMERx does not grant its
approval to any disclosures, assignments, transfers or attempted
assignments or transfers of product rights by ▇▇▇▇▇▇ to any of the
following: *********************************** their respective
subsidiaries and affiliated companies.
4. CONSIDERATION
In consideration of TIMERx' consent to a materialized assignment and
transfer as set out above, TIMERx shall be entitled to a royalty of
*************** on the net sales of the Product by the
assignee/transferee.
5. OBLIGATION TO SUPPLY
a. Except as provided herein, and in particular with respect
to the cost of TIMERx set forth in Paragraph 5(b) below, in
connection with an assignment/transfer of the product rights
as contemplated herein, TIMERx undertakes and agrees to supply
each assignee/transferee with TIMERx (or improvements) as set
out in the Agreement, mutatis mutandis, on terms and
conditions equal to those regarding supplies to Leiras unless
otherwise agreed between TIMERx and each assignee/transferee.
b. The price to be charged by TIMERx to the assignee/transferee
in fulfillment of the assignee/transferee's requirements shall
be *********** per kilogram, subject to increase no more often
than once a year, *************************************** All
other TIMERx supply conditions shall remain in force,
************************* sales of TIMERx will be
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F.O.B. ▇▇▇▇▇▇▇▇▇, ▇.▇. (INCOTERMS 1990). Leiras' purchases of
TIMERx in fulfillment of its own requirements shall be under
the terms of the Agreement.
6. INFORMATION
▇▇▇▇▇▇ agrees to inform ▇▇▇▇▇▇ about the enterprises with which ▇▇▇▇▇▇
conducts negotiations concerning possible product sales or transfers as
contemplated herein, at or about at such time as when ▇▇▇▇▇▇ is ready
to present the Appendix B Agreement to a possible assignee/transferee.
▇▇▇▇▇▇ in turn agrees to inform ▇▇▇▇▇▇ about enterprises with which
▇▇▇▇▇▇ conduct negotiations concerning other Oxybutynin product
development projects or similar prior to entering into a definite
agreement.
7. VALIDITY
This Letter of Consent enters into force immediately. The validity
period of this Letter of Consent shall not expire before the Agreement
(as amended as the case may be) has expired.
8. CHOICE OF LAW
In congruence with the corresponding Clause 12 of the Agreement, this
Letter of Consent shall also be governed by and interpreted in
accordance with English law. Any dispute concerning the interpretation
or application of this Letter of Consent shall be referred for
settlement to the Arbitration Institute of the Stockholm Chamber of
Commerce pursuant to the regulations in force. The question of payment
of such expenses arising out of the arbitral proceedings as may be
incurred by the Arbitration and the parties concerned shall likewise be
referred to the Institute for settlement. The arbitration language
shall be English.
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IN WITNESS WHEREOF this Letter of Agreement has been signed and issued
in duplicate on this 26th day of May, 1995.
Date: 5/26/95 Place: ▇▇▇▇▇▇▇▇▇, NY
-------------------------- -----------------------------
TIMERx
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇. By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇.
--------------------------- -------------------------------
Date: June 6, 1995 Place: ▇▇▇▇▇, Finland
-------------------------- -----------------------------
LEIRAS OY
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇
--------------------------- -------------------------------
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LETTER OF AGREEMENT
The parties hereto have today agreed upon the following:
1. PARTIES
TIMERx TECHNOLOGIES
▇▇▇▇ ▇▇▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇▇▇-9970
U.S.A.
in the following TIMERx and
LEIRAS OY
Pansiontie 45-47
FIN-20210 Turku
Finland
in the following Leiras.
1. BACKGROUND
Leiras and TIMERx (formerly ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Co., Inc.) are parties to an
agreement dated July 27th, 1992 (in the following Agreement)
concerning, in particular, Leiras' Cystrin (Oxybutynin) product and the
TIMERx Controlled Release System, and the utilization of a combination
or combinations thereof and/or of developments thereof. Both parties
have subsequently filed patent applications as described below, with
relevance as regards their co-operation under the Agreement. For the
avoidance of doubt and in order to clarify the situation, the parties
have agreed to treat the patents/patent applications in question in the
manner set out herein.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
2. PATENTS/PATENT APPLICATIONS
TIMERx has filed a US patent application on March 4, 1994, which
application has been approved on March 21, 1995 under patent
registration number 5,399,359 (the TIMERx Patent). TIMERx has also
filed International (PCT) Patent Application No. ***********, on March
18, 1994. The TIMERx Patent, patent applications, and all improvements
and enhancements thereon, are and shall remain the property of TIMERx,
worldwide.
Leiras has filed a worldwide patent application on October 24, 1994,
which application is still pending at the date hereof under the patent
application number(s) ********************************** (U.S.A.), and
******************************** (collectively, the Leiras Patent). The
Leiras Patent is and shall remain the property of Leiras, worldwide.
3. LICENCE
TIMERx hereby grants to Leiras a ****************************** licence
to the TIMERx Patent, including also any further registrations thereof
anywhere, together with all patent applications, and all improvements
and enhancements thereon, to utilize in connection with the field of
use set forth in the Agreement, and subject to the same terms and
conditions of the Agreement, except as expressly set forth herein, or
as set forth in the Letter of Consent.
4. TRANSFER BY ▇▇▇▇▇▇ OF PRODUCT RIGHTS
In accordance with the Letter of Consent signed concurrently with this
Letter of Agreement, ▇▇▇▇▇▇ may wish to transfer the product rights set
out in the Agreement to TIMERx in such areas of the world
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
************************************************************** to
TIMERx in a specific area, ******************************************
therewith for the utilization thereof in such specified area. A
transfer of product rights by ▇▇▇▇▇▇ to an assignee/licensee for a
particular Territory shall include a provision that the
assignee/licensee agrees to buy TIMERx for the manufacture, sale or use
of the Oxybutynin-TIMERx product in the Territory directly from TIMERx
Technologies.
5. ROYALTY
a. In consideration of the licence by TIMERx to Leiras as set out
above, TIMERx shall be entitled to a royalty
*************************************** on the U.S. net sales
(as defined in Appendix A) of the product in the question for
the term of the Agreement as extended by the term of the
TIMERx Patent, which the parties anticipate will end March 4,
2014.
b. The royalty payable for net sales (as defined in Appendix A)
********************* After the expiration of the patents
mentioned in Appendix A of the Agreement, which the parties
anticipate will be September 19, 2009, and provided that
TIMERx acquires equivalent patent rights for the TIMERx Patent
in the appropriate European nations, the royalty payable to
TIMERx for net sales outside *******************************
for the life of such patents, which the parties anticipate
will end March 4, 2014.
c. The royalty scheme set out above shall remain unchanged.
Without affecting the rights of TIMERx to maintain and develop
its intellectual
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property and product/patent assortment, Leiras shall have an
automatic licence in accordance with the Agreement, under any
and all subsequent TIMERx Technologies patents insofar as the
substance Oxybutynin in combination with the TIMERx excipient
is concerned.
6. INFRINGEMENTS
The parties agree in accordance with Paragraph 7 of the Agreement, that
any expenses that result from any infringements against the
above-mentioned TIMERx Patent and the Leiras Patent shall be defrayed
by TIMERx with respect to the TIMERx Patent and by ▇▇▇▇▇▇ with respect
to the Leiras Patent.
7. VALIDITY
This Letter of Agreement enters into force immediately and shall remain
valid until the term of the Agreement as extended by the term of the
TIMERx Patent, which the parties anticipate will end March 4, 2014. The
right of ▇▇▇▇▇▇ to utilize the rights granted hereunder shall not be
affected by the expiration of this Letter, and any rights and licenses
granted hereunder shall become non-exclusive and royalty-free. Leiras
shall not be under any obligation to return any material etc. or to
cease using any rights for the reason of the expiration of the validity
period mentioned.
8. CHOICE OF LAW
In congruence with the corresponding Clause 12 of the Agreement, this
Letter of Agreement shall also be governed by and interpreted in
accordance with english law. Any dispute concerning the interpretation
or application of this Letter of Agreement shall be referred for
settlement to the Arbitration Institute of the Stockholm Chamber of
Commerce pursuant to the regulations in force. The question of payment
of such expenses arising out of the arbitral proceedings as may be
incurred by the Arbitration and the parties concerned
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shall likewise be referred to the Institute for settlement. The
arbitration language shall be English.
IN WITNESS WHEREOF this Letter of Agreement has been signed and issued
in duplicate on this 26th day of May, 1995.
Date: 5/26/95 Place: ▇▇▇▇▇▇▇▇▇, NY
-------------------------- -----------------------------
TIMERx
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇. By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇.
--------------------------- -------------------------------
Date: June 6, 1995 Place: ▇▇▇▇▇, Finland
-------------------------- -----------------------------
LEIRAS OY
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇
--------------------------- -------------------------------
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APPENDIX A
CONFIDENTIALITY AGREEMENT
This Agreement is made and entered into this ____ day of ___________ 1995, by
and between:
LEIRAS OY
Pansiontie 45-47
FIN-20210 Turku
Finland
hereinafter referred to as the "DISCLOSER" and
hereinafter referred to as the "RECIPIENT".
WHEREAS, the DISCLOSER possesses information, data and experience relating to
the pharmaceutical specialties listed in the Annex of this Agreement,
hereinafter referred to as the "PRODUCTS";
WHEREAS, such information, data and experience are considered by the DISCLOSER
to be secret and confidential and constitute a valuable commercial asset to the
DISCLOSER;
WHEREAS, the DISCLOSER is willing, subject to the terms and conditions hereof,
to disclose such information, data and experience to the RECIPIENT for the sole
purpose of evaluating its interest in a future co-operation with the DISCLOSER
regarding the PRODUCTS; NOW, THEREFORE, the parties hereto agree as follows:
1. The term "Confidential Information" as used herein means all
information, data and experience of the type referred to above, whether
of a documentary,
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scientific, technical, engineering, operational or economic nature,
supplied to or obtained by the RECIPIENT in written form which relate
to the PRODUCTS and which are disclosed to the RECIPIENT by the
DISCLOSER.
2. In consideration of such disclosure by DISCLOSER the RECIPIENT agrees
to not make use of or to disclose Confidential Information to any third
party except affiliates, consultants and employees (subject to the
provisions of Clause 3 below), unless the DISCLOSER agrees otherwise in
writing or unless such information falls within the following
exceptions, that is:
to the extent it can be established by competent proof that:
A) such Confidential Information was known to the RECIPIENT prior
to the disclosure by the DISCLOSER and was not acquired
directly or indirectly from the DISCLOSER; or
B) such Confidential Information is or becomes publicly known
through no fault or omission attributable to the RECIPIENT; or
C) such Confidential Information is rightfully given to the
RECIPIENT from sources independent of the DISCLOSER; or
D) the RECIPIENT develops the Confidential Information
independently of any disclosure from the DISCLOSER.
3. The RECIPIENT will divulge this Confidential Information only to such
affiliates, consultants and employees who have a need to know of it as
a part of the evaluation of the same and they will hold such
information in confidence in the same manner as they would hold the
RECIPIENT's own proprietary information.
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4. The RECIPIENT will make its evaluation as promptly as possible.
5. If the RECIPIENT has no further interest in the Confidential
Information, or should the DISCLOSER so request, the RECIPIENT shall
promptly return to the DISCLOSER all documents, regarding the
Confidential Information and received from the DISCLOSER.
6. This Agreement contains no direct or implied offer of a license or any
other rights to the PRODUCTS to the RECIPIENT and neither party hereto
shall be obligated to enter into any further agreement(s).
7. This Agreement shall be governed by and interpreted in accordance with
English Law. Any dispute concerning the interpretation or application
of this Agreement shall be referred for settlement to the Arbitration
Institute of the Stockholm Chamber of Commerce pursuant to the
regulations in force. The question of payment of such expenses arising
out of the arbitral proceedings, as may be incurred by the Arbitration
and the parties concerned, shall likewise be referred to the Institute
for settlement. The arbitration language shall be English.
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IN WITNESS WHEREOF this Confidentiality Agreement has been signed and issued in
duplicate on this ____ day of ___________________________, 1995.
Date: Place:
-------------------------- -----------------------------
THE RECIPIENT
By: By:
--------------------------- -------------------------------
Date: Place:
-------------------------- -----------------------------
LEIRAS OY
By: By:
--------------------------- -------------------------------
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APPENDIX B
AGREEMENT
This Agreement is dated the ___ day of _______________, 199__ and is made
between
(hereinafter called [__________________]);
and
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ CO., INC.
▇▇▇▇ ▇▇▇▇▇ ▇▇,
▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇ ▇▇▇▇▇
U.S.A.
(hereinafter called "▇▇▇▇▇▇▇");
WHEREAS
A) Leiras Oy, Pansiontie 45-47, 20210 Turku, Finland (hereinafter
"Leiras") has developed and is in possession of the medical product
CYSTRIN (Oxybutynin), and is the proprietor of valuable knowhow, data,
skills and other information in relation thereto and wishes to further
develop such technology (hereinafter called "the Technology").
B) ▇▇▇▇▇▇▇ is the owner of TIMERx Controlled Release System and certain
patents pertaining thereto (hereinafter called "the ▇▇▇▇▇▇▇
Manufacturing Technology"), all more closely set out in Annex A
attached hereto,
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C) ▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ have cooperated in a "Development Programme" whereby
▇▇▇▇▇▇▇ developed a slow-release tablet/slow-release tablet formulation
for Leiras' Cystrin product, adjusting the TIMERx Controlled Release
System. Leiras and TIMERx have cooperated in the development and
formulation of the Oxybutynin-TIMERx product, which programme is now in
its final stages. TIMERx has completed its portion of the Development
Programme, and any further development will be conducted by ▇▇▇▇▇▇ on
terms to be separately agreed between Leiras and _____________________.
D) The parties also wish to enter into arrangements for the manufacture
and supply of pharmaceutical products using the Technology on the basis
of the terms and conditions set out below.
NOW IT IS HEREBY agreed as follows;
1. DEFINITIONS
In this Agreement the following terms have the following meanings:
1.1 "Oxybutynin"
means Oxybutynin and its pharmaceutically acceptable salts,
enantiomeres and active metabolites.
1.2 "▇▇▇▇▇▇▇ Manufacturing Technology"
means all knowhow, methods, processes, techniques, trade secrets,
specifications, technological information and other data relating to
the manufacture and use of TIMERx and TIMERx Technology which ▇▇▇▇▇▇▇
has heretofore developed.
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1.3 "Leiras Technology"
means all information, knowhow and technology pertaining to Leiras
Cystrin Technology and the CYSTRIN (Oxybutynin) product and the
manufacturing of the said product.
1.4 "Product Specification"
means the final product specification for the CYSTRIN slow-release
product prepared in the Development Programme in relation to the
commercial supply of CYSTRIN slow-release products.
1.5 "Product"
means the product referred to in item (C) in the WHEREAS-section of
this Agreement.
1.6 "Territory"
means _______________________.
1.7 "TIMERx"
means the slow-release system developed by ▇▇▇▇▇▇▇.
References to Clauses and Schedules are to Clauses and Schedules of this
Agreement.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
2. ROYALTIES
2.1 In consideration of the licenses and rights granted herein,
[_________________] shall pay ▇▇▇▇▇▇▇ a royalty of ***************
calculated on [_______________________] net ex factory sales prices of
the Product.
2.2 ▇▇▇▇▇▇▇ shall be entitled to verify [____________________'] net
sales of the Product by an independent third-party auditor to be
appointed and paid by ▇▇▇▇▇▇▇ with the consent of
[______________________], which consent shall not be unreasonably
withheld.
2.3 Within sixty (60) days of the end of each [___________] fiscal
quarters ending March 31st, June 30th, September 30th and December 31st
of each fiscal year commencing with the first fiscal quarter during
which the Product has been sold by [__________________],
[______________] shall provide ▇▇▇▇▇▇▇ with a true and complete
statement accounting for all sales of the Product by
[____________________] during such fiscal quarter. Within thirty (30)
business days after rendering such statement, [_________________] shall
pay ▇▇▇▇▇▇▇ the royalties due thereunder on the basis of this
Agreement.
3. CONFIDENTIALITY
Each party recognizes that they have been and will be granted access to
proprietary information of the other in connection with their co-operation as
set forth herein.
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3.1 The parties hereto undertake during the period of this Agreement and
subject to Clause 3.3 without limit in time thereafter:
3.1.1 to use the confidential information received from the other
party (hereinafter called "Confidential Information") solely
for the purpose of performing its obligations and using its
rights under this Agreement and for no other purpose
whatsoever without the prior written consent of the disclosing
party.
3.1.2 to hold the Confidential Information received from the
disclosing party in strictest confidence (subject to Clause
3.1.1).
3.2 In the event of one party visiting any of the offices or other premises
of the other party, the visiting party undertakes that any of the
information which may come to its knowledge as a result of any such
visit inclusive of the form, materials and design of the various
elements of any plant and machinery which may be seen at such offices
or premises as well as the plant as a whole, the method of operation
and the various applications thereof shall be Confidential Information
for the purpose of this Agreement.
3.3 It is agreed and understood that nothing contained herein shall be
considered Confidential Information, if:
3.3.1 it is and can be shown to be already known to the recipient at
the time of disclosure;
3.3.2 it subsequently becomes lawfully and freely available to the
recipient from a third party not under a duty of
confidentiality to the disclosing party;
3.3.3 it is in the public domain or is subsequently disclosed to the
public other than through the recipient or any other person to
whom the recipient is permitted to disclose the Confidential
Information under this Agreement;
3.3.4 it is required to be disclosed by law or otherwise with
mandatory effect.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
4. LICENSE OF ▇▇▇▇▇▇▇ PATENTS, INFORMATION AND TECHNOLOGY; SALES OF TIMERx
4.1 ▇▇▇▇▇▇▇ hereby grants [________________], an exclusive, unlimited but
nontransferable right and license throughout the Territory to
manufacture, use and sell the Product contemplated herein by utilizing
the ▇▇▇▇▇▇▇ Manufacturing Technology including, without limitation,
patents and other ▇▇▇▇▇▇▇ information pertaining to TIMERx.
4.2 [_____________________] shall purchase directly from ▇▇▇▇▇▇▇ all of its
requirements of TIMERx for the Product's manufacture, use or sale in
the Territory and ▇▇▇▇▇▇▇ shall sell [_______________] all of
[_________________'] requirements of TIMERx for the said purpose. The
price to be charged by TIMERx to [______________________] in
fulfillment of [_____________________'s] requirements shall be
*****************, subject to increase no more often than once a year,
and *******************************************************, whichever
is less.
4.3 ▇▇▇▇▇▇▇ hereby warrants that the TIMERx sold or to be sold to
[___________________] hereunder will meet, at the time of shipment and
receipt by [____________________] thereof, the specifications attached
hereto as Annex B and incorporated herein by this reference. ▇▇▇▇▇▇▇
also warrants that (i) it will, at the time of shipment and receipt
thereof, have a good and marketable title to the TIMERx sold to
[_______________] 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.
4.4 All sales of TIMERx shall be F.O.B. ▇▇▇▇▇▇▇▇▇, New York (INCOTERMS
1990).
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5. INFRINGEMENT
5.1 ▇▇▇▇▇▇▇ warrants that, to the best of its knowledge, the use by
[__________________] of the ▇▇▇▇▇▇▇ Manufacturing Technology in
accordance with the terms of this Agreement will not infringe the
intellectual property or other proprietary rights of any third party.
▇▇▇▇▇▇▇ shall defend, indemnify and hold [_________________] harmless
from and against all claims, actions, liabilities and costs, including,
without limitations, reasonable attorneys' fees and expenses, suffered
or incurred by [_______________] based upon or arising out of a claim
of infringement or contributory infringement of any patent, or the
violation of another's trade secret rights, by reason of the practice
or use of the ▇▇▇▇▇▇▇ Manufacturing Technology or of TIMERx provided by
▇▇▇▇▇▇▇ to [______________] pursuant to this Agreement.
6. TERM AND TERMINATION
6.1 This Agreement shall commence with effect from the date hereof and,
unless terminated earlier pursuant to Clause 6.2, shall continue until
the last effective and enforceable date of any of the patents listed in
Annex A, which the parties anticipate will be March 4, 2014.
6.2 If one party (hereinafter called "the Defaulting Party"):
6.2.1 is in material breach of its obligations under this Agreement;
or
6.2.2 becomes insolvent or enters into liquidation (other than as a
party of a scheme for solvent reconstruction or amalgamation)
or makes an 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
6.2.3 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)
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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 a breach capable of remedy, the defaulting party shall
have sixty (60) days or fourteen (14) days in the case of
non-payment of monies 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.
7. 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,
the license granted shall become non-exclusive and royalty-free.
8. FORCE MAJEURE
If and to the 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.
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23
9. NOTICES
9.1 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:
9.1.1 at the time when the same is handed to or left at the address
of the party to be served;
9.1.2 by post on the day (not being a Sunday or public holiday)
five (5) days following the day of posting; and
9.1.3 in the case of a telegram, telex or facsimile transmission on
the next following day.
9.2 Notices shall be addressed to the parties under their above-mentioned
addresses.
9.3 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).
10. CHOICE OF LAW
This Agreement shall be governed by and interpreted in accordance with
English Law. Any dispute concerning the interpretation or application
of this Agreement shall be referred for settlement to the Arbitration
Institute of the Stockholm Chamber of Commerce pursuant to the
regulations in force. The question of payment of such expenses arising
out of the arbitral proceedings, as may be incurred by the Arbitration
and the parties concerned, shall likewise be referred to the Institute
for settlement. The arbitration language shall be English.
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24
11. ASSIGNMENT
This Agreement may not be assigned by either party without the prior
written consent of the other. Should ▇▇▇▇▇▇▇ sell all or substantially
all of its assets, or should ▇▇▇▇▇▇▇ itself or a major party thereof be
sold, transferred, assigned or similar to a third party,
[_________________] shall have the right to terminate this Agreement
forthwith.
12. 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.
13. 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 thereof, 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 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.
14. SOLE UNDERSTANDING
No representations, warranties, conditions or other statements not
contained herein shall be binding on the parties hereto, and no
variation of the terms hereof
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25
shall be binding on the parties unless made in writing by the
authorized representatives of the parties. This Agreement and the
documents referred to herein together contain the entire agreement
between the parties with respect to its subject matter and supersede
and replace all prior agreements written or oral with respect thereto.
15. PARTNERSHIP
Nothing in this Agreement shall constitute a partnership between the
parties hereto.
16. HEADINGS
The headings of Clauses shall not affect their interpretation.
17. 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.
[_______________________] ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ CO., INC.
Date: ____________________ Date: _____________________
Place: _____________________ Place: ____________________
By: ______________________ By: _______________________
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26
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
ANNEX A
"▇▇▇▇▇▇▇ MANUFACTURING TECHNOLOGY"
To the Agreement between LEIRAS OY and ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ CO., INC. of
_____________________, 199_.
LIST OF PATENT AND PATENT APPLICATIONS COVERING TIMERx
1) U.S. Patent No. 4,994,276, entitled "Directly Compressible Slow Release
Granulation," issued February 19, 1991.
2) U.S. Patent No. 5,128,143, entitled "Sustained Release Excipient and
Tablet Formulation," issued July 7, 1992.
3) U.S. Patent No. 5,135,757, entitled "Compressible Sustained Release
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) U.S. Application Serial No. **************************************
6) U.S. Patent Application Serial No. 08/206,416, 08/206,416, filed March
4, 1994, issued as U.S. Patent No. 5,399,359 on March 21, 1995,
"CONTROLLED RELEASE OXYBUTYNIN FORMULATIONS."
7) International (PCT) Patent Application No.*************************