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EXHIBIT 10.9
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
AGREEMENT
This Agreement is dated the 27th day of July, 1992 and is made between
LEIRAS OY
Xxxxxxxxxx 00 - 00
00000 Xxxxx
XXXXXXX
(hereinafter called "Leiras");
and
XXXXXX XXXXXXX CO., INC.
0000 Xxxxx 00, Xxxxxxxxx
Xxx Xxxx 00000 X.X.X.
(hereinafter called "Xxxxxxx");
WHEREAS
A) 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) Xxxxxxx is the owner of TIMERx Controlled Release System and certain
patents pertaining thereto (hereinafter called "the Xxxxxxx
Manufacturing Technology"), all more closely set out in Annex A attached
hereto.
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C) The parties are interested in co-operation whereby Xxxxxxx develops a
slow-release tablet/slow-release tablet formulation for Leiras' Cystrin
product, adjusting the TIMERx Controlled Release System and on the basis
of the development programme more closely defined below.
D) The parties also wish to enter into arrangements for the manufacture and
supply of pharmaceutical products by Leiras using the Technology on the
basis of the terms and conditions set out below.
NOW IT IS HEREBY agreed as follows;
1. DEFINITIONS
1.1. In this Agreement the following terms have the following meanings:
"Oxybutynin"
means Oxybutynin and its pharmaceutically acceptable salts, enantiomeres
and active metabolites.
"Xxxxxxx 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 Xxxxxxx has
heretofore developed or which are developed by it in the course of the
Development Programme.
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"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.
"Development Programme"
means the programme of work agreed in writing between the parties from
time to time for the development of CYSTRIN slow-release and
Cystrin-TIMERx slow-release tablet as a pharmaceutical product capable
of commercial utilization by Leiras exclusively including milestones to
be achieved, cost estimates and relevant time schedules, the current
programme being in the form annexed hereto marked "B".
"Development Specification"
means the CYSTRIN slow-release mode preformulation developed by Xxxxxxx
for clinical trials and approved by Leiras.
"Effective Date"
means the date hereof.
"Product Specification"
means the final product specification for the CYSTRIN slow-release
product prepared by the parties (to be approved by Leiras in writing) in
relation to the commercial supply of CYSTRIN slow-release products by
Leiras.
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"Project Commencement Date"
means the date hereof.
"Product"
means the product referred to in item (C) in the WHEREAS-section of this
Agreement.
"Territory"
means worldwide.
"TIMERx"
means the slow-release system developed by Xxxxxxx.
1.2. References to Clauses and Schedules are to Clauses and Schedules of this
Agreement.
2. Development Programme
2.1. After the Effective Date, Leiras shall provide Xxxxxxx with the
Oxybutynin active ingredient for the purposes hereof, and Xxxxxxx shall
begin the development work set out herein. Xxxxxxx shall use its best
efforts to complete the development of CYSTRIN slow-release in
accordance with the Development Programme.
2.2 Leiras shall pay Xxxxxxx for the development and engineering work
carried out by Xxxxxxx hereunder as set out in Annex B attached hereto.
Within
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************** after completion of each development stage, Xxxxxxx shall
provide Leiras with a report detailing the data and findings from such
stage. Leiras shall then, at its discretion, decide whether it wishes to
continue with the Development Programme as set out herein, or whether
the Development Programme shall be discontinued. Xxxxxxx shall not
commence any new stage until it has received written consent from Leiras
to commence such new stage.
2.3. Leiras may, during the continuance of this Agreement, at its own
expense, send engineers and other suitably qualified employees to visit
Xxxxxxx'x premises for the purpose of familiarizing themselves with the
development work in connection with CYSTRIN slow-release.
2.4. Should Leiras so request, Xxxxxxx shall offer Leiras consultancy
assistance e.g. by sending such of its employees to Leiras as are to be
agreed upon separately in order to assist Leiras in matters pertaining
to production and quality control. The terms and conditions of such
assistance are to be agreed upon separately.
3. INTELLECTUAL PROPERTY RIGHTS
3.1. The parties confirm their understanding that;
a) The result of the slow-release development programme set out herein and
the Product shall be the property of Leiras. Leiras is also the sole
proprietor of its Cystrin knowhow, as well as further inventions,
developments, improvements etc. both as regards Cystrin and Oxybutynin
with no rights assigned or licensed to Xxxxxxx, unless otherwise set out
herein.
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b) Leiras acknowledges Xxxxxxx'x industrial and other rights to the TIMERx
and the TIMERx Technology (including also further inventions,
developments, improvements etc.), with regard to which Leiras has
received a license in accordance with this Agreement to the extent the
Product comprises TIMERx and TIMERx Technology.
3.2. Leiras acknowledges that Oxybutynin slow-release may incorporate and in
part be made in accordance with certain technology and knowhow which are
and shall remain the property of Xxxxxxx. Xxxxxxx shall be free to
exploit and supply such technology to third parties other than for use
with Oxybutynin slow-release products.
3.3. Xxxxxxx shall provide Leiras with such of the Technology owned by it as
it considers necessary to enable Leiras to perform its obligation and to
carry out its functions under this Agreement. The provisions of Clause 5
shall apply in relation to any part of the Technology which is
Confidential Information. The compensation payable by Leiras to Xxxxxxx
for Technology to be licensed by Xxxxxxx to Leiras shall be as set out
in Clause 4 below.
4. ROYALTIES
4.1. In consideration of the licenses and rights granted herein, Leiras shall
pay Xxxxxxx a royalty of **********************************************
************************.
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4.2. Xxxxxxx shall be entitled to verify Leiras' net sales of the Product by
an independent third-party auditor to be appointed and paid by Xxxxxxx
with the consent of Leiras, which consent shall not be unreasonably
withheld.
4.3. Within sixty (60) days of the end of each Leiras 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 Leiras, Leiras shall provide Xxxxxxx with a true and
complete statement accounting for all sales of the Product by Leiras
during such fiscal quarter. Within thirty (30) business days after
rendering such statement, Leiras shall pay Xxxxxxx the royalties due
thereunder on the basis of this Agreement.
5. CONFIDENTIALITY
5.1. 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.
5.2. The parties hereto undertake during the period of this Agreement and
subject to Clause 5.4. without limit in time thereafter;
a) 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.
b) to hold the Confidential Information received from the disclosing party
in strictest confidence (subject to Clause 5.2.a).
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5.3. 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.
5.4. It is agreed and understood that nothing contained herein shall be
considered Confidential Information, if;
a) it is and can be shown to be already known to the recipient at the time
of disclosure;
b) it subsequently becomes lawfully and freely available to the recipient
from a third party not under a duty of confidentiality to the disclosing
party;
c) 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;
d) it is required to be disclosed by law or otherwise with mandatory
effect.
6. LICENSE OF XXXXXXX PATENTS, INFORMATION AND TECHNOLOGY; SALES OF TIMERx
6.1. Xxxxxxx hereby grants Leiras an exclusive, unlimited but nontransferable
right and license throughout the Territory to manufacture, use and sell
the Products contemplated herein by utilizing the Xxxxxxx Manufacturing
Technology
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including, without limitation, patents and other Xxxxxxx information
pertaining to TIMERx.
6.2. Leiras shall use its best efforts in the promotion of the Product
worldwide, taking into consideration the competitive advantage and
superiority pertaining to the Product, Leiras' resources, acts and
measures by competitors, etc. In particular with respect to the United
States of America, Leiras shall consult Xxxxxxx regarding distribution
arrangements and alternatives. Leiras shall also be entitled to ask for
Xxxxxxx'x assistance in the choice of a partner for the US area. For
guidance purposes, the parties shall seek to agree upon an estimated
time schedule for the marketing of the Products in the US area, with
possible milestones to be agreed upon separately.
6.3. In case Leiras decides to manufacture the TIMERx slow-release product on
the basis of the results of the Development Programme, Leiras shall
purchase from Xxxxxxx all of its requirements of TIMERx for the Product,
and Xxxxxxx shall sell Leiras all of Leiras' requirements of TIMERx for
the said purpose provided that if Xxxxxxx is unable to supply all of the
TIMERx required by Leiras within sixty (60) days after Leiras gives
notice to Xxxxxxx of such requirements for a specific dosage form, then
Xxxxxxx shall put the information etc. necessary for the production of
TIMERx at the disposal of Leiras for the sole and only purpose of
enabling Leiras to manufacture such amounts of TIMERx as Xxxxxxx is
unable to supply to Leiras but for no other purpose whatsoever and such
information etc. to be used solely by Leiras for the purpose set out
herein, and only for such time as Xxxxxxx is unable so to supply. Leiras
shall use all TIMERx sold by Xxxxxxx to Leiras hereunder solely and
exclusively in connection with the license granted by Xxxxxxx pursuant
to this Agreement and in particular to this Clause 6.
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6.4. Xxxxxxx shall sell TIMERx to Leiras for a price of *******************.
Such price shall be valid for a period of ********** from the first
launch of the Products. Thereafter, Xxxxxxx shall be entitled to
increase or decrease such price from the ******************************
*********************************. Leiras shall be entitled to negotiate
with Xxxxxxx both before launching the Product and the start of
marketing thereof, and thereafter, with the aim of adjusting such price
to a level mutually acceptable by both parties.
6.5. Xxxxxxx shall invoice Leiras at the time any TIMERx sold hereunder is
shipped to Leiras. Payment of such invoice is due sixty (60) days from
the date of such invoice.
6.6. Shipments of TIMERx shall be made upon Leiras' instruction and delivery
will be CIP Turku (Incoterms 1990).
6.7. Xxxxxxx hereby warrants that the TIMERx sold or to be sold to Leiras
hereunder will meet, at the time of shipment and receipt by Leiras
thereof, the specifications attached hereto as Appendix C and
incorporated herein by this reference. Xxxxxxx 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 Leiras 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.
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7. INFRINGEMENT
Xxxxxxx warrants that, to the best of its knowledge, the use by Leiras
of the Xxxxxxx Manufacturing Technology in accordance with the terms of
this Agreement will not infringe the intellectual property or other
proprietary rights of any third party. Xxxxxxx shall defend, indemnify
and hold Leiras harmless from and against all claims, actions,
liabilities and costs, including, without limitation, reasonable
attorneys' fees and expenses, suffered or incurred by Leiras 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 Xxxxxxx Manufacturing Technology or
of TIMERx provided by Xxxxxxx to Leiras pursuant to this Agreement.
Leiras warrants that, to the best of its knowledge, its contribution to
the development project and to the Product does not infringe the
intellectual property rights of any third party. Should Leiras be in
violation of this warrant, Leiras will defend, indemnify and hold
Xxxxxxx harmless from and against all claims based upon such breach of
warrant.
8. TERM AND TERMINATION
8.1. This Agreement shall commence with effect from the date hereof and,
unless terminated earlier pursuant to Clause 8.2. or 8.3. inclusive,
shall continue until the expiration of the Xxxxxxx patents mentioned in
Appendix A.
8.2. If one party (hereinafter called "the Defaulting Party")
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a) is in material breach of its obligations under this Agreement; or
b) becomes insolvent or enters into liquidation (other than as part 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
c) is unable by reason of the events and circumstances referred to in
Clause 10 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 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.
9. CONSEQUENCES OF TERMINATION
9.1. 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 those set out in Clauses 3, 5, 7, 9 and 12, 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.
9.2. In the event of termination or expiry of this Agreement howsoever
arising Xxxxxxx shall deliver to Leiras within fifteen (15) working days
all and
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
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everything set out in the Leiras Technology, the Development Programme,
the Development Specification and the Project Specification or other
materials which are the property of Leiras and as is in its direct or
indirect possession, and Leiras shall be under an equivalent obligation
with respect to Xxxxxxx Technology and Xxxxxxx materials, mutatis
mutandis.
9.3. On termination or expiry of this Agreement each party shall return the
other party, at the other party's cost, all designs, drawings,
specifications, materials and other information comprising and relating
to the other party's Technology as is in such party's possession and
shall cease all further use of the same.
9.4. Leiras shall be entitled to terminate the development work set out
herein at each "Go/No Go" point mentioned in the Development Programme.
Leiras shall also decide, at its sole discretion, whether the result of
the Development Programme shall lead to a registration, manufacturing
and marketing of the Product. Should Leiras decide to discontinue the
Development Programme or to refrain from registering, manufacturing and
marketing the Product, the parties have agreed that:
a) Should Leiras make the "No Go"-decision after phase 2 of the
Development Programme, Xxxxxxx shall be entitled to use the Leiras
project for reference purposes in its promotion after ******************
from such Leiras' decision, provided that Xxxxxxx shall keep any and all
Leiras' Confidential Information strictly in confidence. Xxxxxxx is
neither entitled to transfer nor disclose any development results to any
third parties. Either party shall not be responsible
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for compensation to the other party with respect to the discontinuation
of the development work hereof.
b) Should Leiras make the "No Go"-decision after phase 4 of the
Development Programme, Xxxxxxx shall also be entitled to use the Leiras
project for reference purposes in its promotion after ******************
from such Leiras' decision on the same provisions of confidentiality as
set out in Subclause 9.4.a) hereinabove. Furthermore, in addition to the
compensation set forth in the Development Programme, Leiras shall pay
Xxxxxxx a total compensation of ********** in consideration of Xxxxxxx'x
reasonable overhead costs.
c) Should Leiras make the "No Go"-decision, or should Leiras decide to
discontinue the manufacturing and marketing of the Product any time
after phase 5 of the Development Programme, Xxxxxxx shall be entitled to
use the Leiras project for reference purposes in its promotion after
****************** from such Leiras' decision on the provisions set out
in Subclause 9.4.a) hereinabove. Furthermore, in addition to the
compensation set forth in the Development Programme, Leiras shall pay
Xxxxxxx a total compensation of *********** in consideration of
Xxxxxxx'x reasonable overhead costs.
In the event Leiras decides to discontinue the development work hereof,
Leiras has free and unencumbered right to use, transfer and sell the
results of the development work. Should Leiras elect to transfer the
right to a third party, Leiras shall be obligated to transfer this
Agreement also to such third party.
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9.5. Upon termination of this Agreement or the discontinuation of the
Development Programme and/or the registering, manufacturing and
marketing of the Product, as applicable, Xxxxxxx shall have no right to
use the Development Programme, the results thereof or anything else of a
proprietary nature belonging to Leiras, whether for its own or for third
party purposes. However, Xxxxxxx shall be entitled to utilize the
Xxxxxxx-generated information for publicity purposes only, and may, in
this respect, disclose Leiras as the company holding the worldwide
rights to the Oxybutynin-TIMERx product. The manner of such disclosure
shall be agreed upon between the parties in advance.
10. 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.
11. NOTICES
11.1. 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 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
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time notify to the other. Any such notice or other communication shall
be deemed to be given;
a) at the time when the same is handed to or left at the address of
the party to be served;
b) by post on the day (not being a Sunday or public holiday) five
(5) days following the day of posting; and
c) in the case of a telegram, telex or facsimile transmission on
the next following day.
11.2. Notices shall be addressed to the parties under their above-mentioned
addresses.
11.3. 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).
12. 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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13. ASSIGNMENT
This Agreement may not be assigned by either party without the prior
written consent of the other unless otherwise follows from Clause 9.4.
Should Xxxxxxx sell all or substantially all of its assets, or should
Xxxxxxx itself or a major part thereof be sold, transferred, assigned or
similar to a third party, Leiras shall have the right to terminate this
Agreement forthwith.
14. 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.
15. 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 enforceable,
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.
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16. 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 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.
17. PARTNERSHIP
Nothing in this Agreement shall constitute a partnership between the
parties hereto.
18. HEADINGS
The headings of Clauses shall not affect their interpretation.
19. 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.
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IN WITNESS WHEREOF the parties have caused this Agreement to be executed
by their duly authorized officers.
Date: June 30, 1992 Date: July 27, 1992
Place: Turku Place: Patterson, N.Y.
LEIRAS OY XXXXXX XXXXXXX CO., INC.
/s/ [illegible] /s/ [illegible]
-------------------------------- ----------------------------
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ANNEX A
"XXXXXXX MANUFACTURING TECHNOLOGY"
to the Agreement between LEIRAS OY and XXXXXX XXXXXXX CO., INC. of July
27, 1992.
LIST OF PATENT AND PATENT APPLICATIONS COVERING TIMERx:
1) U.S. Patent No. 4,994,276 entitled "Directly Compressible Slow
Release Granulation", filed Sept. 19, 1988
2) U.S. Serial No. 491,189 entitled "Sustained Release Excipient",
filed March 9, 1990
3) U.S. Application entitled "Compressible Sustained Release Solid
Dosage Forms", filed Jan. 16, 1991
4) European Patent Application, Publication No. 0360562 entitled
"Directly Compressible Sustained Release Excipient", filed Sept.
19, 1989.
Date: June 30, 1992 Date: July 27, 2992
Place: Turku Place: Patterson, N.Y.
LEIRAS OY XXXXXX XXXXXXX CO., INC.
/s/ [illegible] /s/ [illegible]
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ANNEX B
"DEVELOPMENT PROGRAMME"
to the Agreement between LEIRAS OY and XXXXXX XXXXXXX CO., INC. of July
27, 1992.
PRODUCT DEVELOPMENT AGREEMENT:
Payment
-------
1. Agreement exchange. After sign of the **********
Agreement a fee of ************* will be
paid.
2. The work in Xxxxxxx'x laboratory will consist of:
***********************************
***********************************
***********************************
The target is ********************************.
Data from stages 1 - 2 will be presented within
8 - 12 weeks.
3. "Go/No Go"-decision.
4. If the decision is "Go", a fee of **********
***************** will be paid.
Development of the Product in laboratory scale
(Xxxxxxx). The work will consist of:
**************************************
**************************************
*****************************
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*************************************
*************************************
*************************************
*************************************.
Final tablets and data from stages
1 - 4 will be presented **************
5. "Go/No Go"-decision.
6. If the decision is "Go", a fee of **********
************* will be paid.
Typical activities after stage 5
decision include:
**********************************
**********************************
**********************************
7. After registration and marketing, Xxxxxxx will work on a
royalty basis. All development costs outlined above will be
*****************************************************.
TOTAL **********
Date: June 30, 1992 Date: July 27, 1992
Place: Turku Place: Xxxxxxxxx, N.Y.
LEIRAS OY XXXXXX XXXXXXX CO., INC.
/s/ [Illegible] /s/ [Illegible]
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ANNEX C
TIMERx Specification
Description: *********************************************************
**********************************************************************.
****************************** **************************
****************************** **************************
****************************** **************************
****************************** **************************
Final specification to be decided between Leiras and Xxxxxxx based on
the development project.
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