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EXHIBIT 10.7
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
PRODUCT DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT
THIS AGREEMENT is entered into as of the 28th day of February, 1997 (the
"Effective Date"), by and between TIMERx Technologies, a division of Penwest,
Ltd., a Washington corporation, with principal place of business at 2981 Route
22, Patterson, New York 12563, USA ("TIMERx Technologies"), and SANOFI WINTHROP
INTERNATIONAL S.A., a company incorporated under the laws of France, with
registered office at 9 rue du President Salvador Allende, 94250 Gentilly, France
("Sanofi").
A. TIMERx Technologies has developed a controlled-release agent ,
which agent marketed by TIMERx Technologies under the name and trademark
"TIMERx(R)" ("TIMERx") and which is covered by one or more patents, patent
applications, know-how and other proprietary technology of which TIMERx
Technologies or its affiliates are beneficial owner or authorized users.
B. Sanofi is a pharmaceutical company that wishes to develop a 24-
hour controlled release version of nifedipine in tablet form to be marketed in
Europe in the 30mg and 60mg dosage strengths.
C. TIMERx Technologies has developed a specific formulation of
TIMERx which may be combined with nifedipine.
D. The parties desire to engage in certain development, regulatory
and testing activities designed to determine if the formulation of TIMERx
combined with nifedipine as developed by TIMERx Technologies is comparable to
Adalat LA and is capable of registration. If such activities are successful, the
parties desire to allow Sanofi to exclusively manufacture, market and distribute
the Designated Product in the Territory defined herein, and Sanofi desires to
contract for the supply of its requirements of Formulated TIMERx for use in such
manufacture.
NOW, THEREFORE, the parties hereby agree as follows:
1. DEFINITIONS.
1.1. "ADALAT LA" shall mean 24 hour controlled-release nifedipine
manufactured and marketed by BAYER.
1.2. Affiliate" of TIMERx Technologies and "Affiliate" of Sanofi
shall mean and include the entities that, directly or indirectly, own and
control the voting of more than 45% of the voting capital shares of such party
("Parent"), or more than 45% of the voting capital shares (or equivalent
control) of which is, directly or indirectly,
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owned, and the voting of which is controlled, by such party or its Parent, as of
the Effective Date. For purposes of this definition and this Agreement, no
Affiliate shall remain such unless it continues to meet the foregoing criteria,
and neither Bayer nor Pfizer or their affiliates will qualify as an Affiliate of
either party, regardless of any ownership or control relationships.
1.3. "AGREEMENT" shall mean this agreement and all exhibits attached
hereto, which form an integral part hereof.
1.4. "APPROVAL DATE" shall mean, as to each country in the Territory,
the date on which a Designated Product is approved by Regulatory
Authority in such country for commercial sale in oral tablet
form for administration in humans, pursuant to a Product License
Application submitted by or for Sanofi or its Affiliates (a
"PLA"), in the name of Sanofi or its Affiliates.
1.5. "CHEMICAL PRODUCERS' INDEX" shall mean the producers' price
index for commodities currently regularly maintained and
published by the Bureau of Labor Statistics of the U.S. Labor
Department ("BLS") under the group and item name "Chemicals and
allied products" and Series ID WPU06, or, if such index is
discontinued or substantially restructured, "Chemical Producers'
Index" shall mean a successor to such index reasonably
acceptable to both parties as a reasonable equivalent or
substitute index. For purposes of calculations to be made
hereunder, the most recent published index for the reporting
period ending most recently prior to the then-current month in
which such adjustment is being made hereunder shall be used,
even though such index may be designated as "preliminary" and
even though it may thereafter be adjusted by the BLS or other
entity publishing such index.
1.6. "CONFIDENTIAL TECHNOLOGY" shall mean all technology that is, at
the relevant time hereunder, protected or required to be
protected by both parties hereto as confidential information
pursuant to Section 8 hereof.
1.7. "DESIGNATED PRODUCT" shall mean a tablet form of a
controlled-release pharmaceutical for oral administration in
humans that combines nifedipine with Formulated TIMERx and other
excipients in 30mg and 60mg dosage strengths and which conforms
in all respects with the Specifications.
1.8. "DEVELOPMENT PERIOD" shall mean the period from the Effective
Date through the earlier of the termination of this Agreement as
provided herein or the approval of the Phase II Dissolution
Profile Studies by Sanofi pursuant to Section 3.3.
1.9. "DISSOLUTION PROFILE STUDIES" shall mean the in vitro studies to
compare
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Adalat LA from the Territory to the Designated Product, as more
fully described in Exhibit . The "Phase I Dissolution Profile
Studies" will be conducted by TIMERx Technologies using
Designated Product manufactured by Mylan Pharmaceuticals. The
"Phase II Dissolution Profile Studies" will be conducted by
Sanofi using Designated Product manufactured by Sanofi.
1.10. "EXCLUSIVITY PERIOD" shall mean, with respect to each country in
the Territory and subject to earlier transformation into
non-exclusive rights, as provided in Section 11.2, the period
during the License Term until there are no longer any TIMERx
Technologies Patents in that country applicable to the
Designated Product or, if later, until all of TIMERx
Technologies' Confidential Technology provided to Sanofi
hereunder has been disclosed without restriction to the public
(but in this case, where there are no longer any TIMERx
Technologies Patents in that country applicable to the
Designated Product, the Exclusivity Period will not last longer
in such country than ten years from the later of the first
Approval Date or the first Other Governmental Approval Date in
any country in the European portion of the Territory).
1.11. "FORMULATED TIMERx" shall mean TIMERx and certain additives in
a formulation which has been developed by TIMERx Technologies
specifically for use in the Designated Product and which is
referred to by TIMERx Technologies as "TIMERx-N." The Formulated
TIMERx will be identical in all respects to TIMERx (also
referred to by TIMERx Technologies as "TIMERx-N") to be supplied
by TIMERx Technologies to Mylan Pharmaceuticals pursuant to
their license agreement calling for registration with the US FDA
of the Designated Product using such TIMERx-N.
1.12. "LICENSE TERM" shall mean the cumulative period covered by the
Development Period, the Regulatory Period, and the Marketing
Period.
1.13. "MARKETING PERIOD" shall mean the period (not being a period of
more than 20 years from the Effective Date) beginning on the
later of the Approval Date or the Other Governmental Approval
Date in the particular country and ending on the earlier of:
1.13.1. the tenth, thirteenth, sixteenth, or nineteenth
anniversary of the first Approval Date (or, if later,
the first Other Governmental Approval Date) in any
country in the Territory, if either party so notifies
the other at least one hundred eighty (180) days prior
to such anniversary that the Marketing Period will end
on such anniversary; or
1.13.2. the termination of the License Term and/or this
Agreement as
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
provided herein;
provided, however, that the Marketing Period may be
ended sooner with respect to a country or group of
countries (as indicated in Exhibit 11.2) pursuant to
Section 11.3, in which event such country or group shall
be deemed thereafter removed from the Territory for all
purposes of this Agreement.**
1.14. "NET SALES" shall mean *****************************************
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*********
1.15. "OTHER GOVERNMENTAL APPROVAL DATE" shall mean, as to each
country in the Territory, the date on which a Designated Product
is approved by all required governmental agencies in such
country (other than the Regulatory Authority) for commercial
sale in such country.
1.16. "PER-KILOGRAM PRICE" shall mean ****** for each kilogram of
Formulated TIMERx sold hereunder during the three years
following the Effective Date, and shall mean, for each kilogram
sold thereafter, such ******, subject to upward adjustment if
mutually agreed by the parties (which agreement shall not be
unreasonably withheld), taking into account changes in the
Chemical Producers' Index since the Effective Date.
1.17. "PIVOTAL PHARMACODYNAMIC STUDIES" shall mean the studies
undertaken by Sanofi, as more fully described in Exhibit and
designed to support the submission to the Regulatory Authority
of a PLA for the Designated Product (whether or not such PLA is
ultimately approved).
1.18. "PRODUCT PRODUCTION TECHNOLOGY" shall mean TIMERx Technologies'
rights under the TIMERx Technologies Patents and any and all
other patents, patent applications, and other technology and
know-how belonging to TIMERx Technologies from time to time
during the term of this Agreement that directly relate to, and
are necessary for the production of, the Designated Product from
Formulated TIMERx supplied by TIMERx Technologies.
1.19. "PROJECT CONTACT(S)" shall mean the persons appointed by each
party to serve as contact persons between the parties during the
Development Period and the Regulatory Period. The initial
Project Contact for TIMERx Technologies for business matters is
Michael T. Mallon, and the initial Project Contact for TIMERx
Technologies for technical and
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scientific matters is Dr. Dileep Bhagwat. The initial Project
Contact for Sanofi for business matters is Dr. John Buckle, and
the initial Project Contact for Sanofi for technical and
scientific matters is Dr. Brian Bond (both based at Sanofi
Winthrop Ltd., but each of whom have full authority to act as a
Project Contact for Sanofi hereunder). Each party shall promptly
notify the other party of any substitution of other personnel as
its Project Contact(s). Each party may select and supervise its
other project staff as needed.
1.20. "REGULATORY AUTHORITY" shall mean the competent authority for
each country of the Territory or for the European Union or for
any other relevant grouping of countries in the Territory
legally responsible for authorising the sale or supply of
medicinal products in that country, Union or grouping of
countries as the case may be.
1.21. "REGULATORY PERIOD" shall mean the period beginning at the end
of the Development Period and ending on the earlier of:
1.21.1. the later of the Approval Date or the Other Governmental
Approval Date in all countries of the Territory; or
1.21.2. the termination of this Agreement as provided herein.
1.22. "ROYALTIES" shall mean the royalties payable to TIMERx
Technologies pursuant to Section 5.5 hereof.
1.23. "SANOFI IMPROVEMENTS" shall mean any and all improvements,
modifications, alterations, or enhancements to any of the
inventions covered by the TIMERx Technologies Patents, TIMERx
Technologies' Confidential Technology, the Product Production
Technology, or the TIMERx Production Technology, that are
developed, owned, or controlled by Sanofi or any of its
Affiliates or sublicensees at any time during the License Term
(to the extent the same are discloseable by Sanofi without
violation of duties of confidentiality owed to third parties).
1.24. "SANOFI TEST AND REGULATORY DATA" shall mean any and all test
data, test designs and protocols, clinical studies and results
thereof (including without limitation the Phase II Dissolution
Profile Studies and the Pivotal Pharmacodynamic Studies and any
other studies required by Regulatory Authorities or otherwise
prepared by or for Sanofi, more specifically called herein the
"Sanofi Clinical Data"), government licenses and applications
therefor, government certifications and findings, and
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
related materials, information and rights (including without
limitation information regarding any adverse drug reactions),
developed, commissioned or otherwise obtained by Sanofi or any
of its Affiliates or sublicensees during the term of this
Agreement relating to controlled- release nifedipine in 30mg
and/or 60mg dosage strengths (to the extent the same are
discloseable by Sanofi without violation of duties of
confidentiality owed to third parties), TIMERx, Sanofi
Improvements, the Designated Product, TIMERx Technologies
Patents, Product Production Technology, TIMERx Production
Technology and/or TIMERx Technologies' Confidential Technology.
For the avoidance of doubt TIMERx Technologies Test and
Regulatory Data are excluded from this definition.
1.25. "SANOFI TRADEMARKS" shall mean trademarks which are the
exclusive property of and which will remain at all times the
exclusive property of Sanofi or its Affiliates.
1.26. "SPECIFICATIONS" shall mean, as determined by the context in
which such term is used: (i) the description and product
specification for the Designated Product set forth in Exhibit
1.26A, together with such variations to the standards and
analytical methods agreed by TIMERx Technologies and Sanofi and
approved by the Regulatory Authority in the PLA in each country
of the Territory (subject to Section 4.8); and/or (ii) the
description and product specification for the Formulated TIMERx
set forth in Exhibit 1.26B, which are identical to those used or
designed to be used in the production of Formulated TIMERx for
use in Designated Product for sale outside the Territory by
TIMERx Technologies or its licensees, together with such
variations to the standards and analytical methods agreed by
TIMERx Technologies and Sanofi and approved by the Regulatory
Authority in the PLA in each country of the Territory (subject
to Section 4.8).
1.27. "TERRITORY" shall mean the countries **************************
1.28. "TIMERx" is a customized blend or blends of homopolysacharides
and heteropolysacharides and other additives as exemplified in
one or more of the TIMERx Technologies Patents in Exhibit 1.31.
1.29. "TIMERx IMPROVEMENTS" shall mean any and all improvements,
modifications, alterations, or enhancements to any of the
inventions covered by the TIMERx Technologies Patents, TIMERx
Technologies' Confidential Technology, the Product Production
Technology, or the TIMERx Production Technology, that relate to
the Designated Product and that are developed, owned, or
controlled by TIMERx or any of its
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Affiliates, sublicensees or subcontractors at any time during
the License Term (to the extent the same are discloseable by
TIMERx Technologies without violation of duties of
confidentiality owed to third parties).
1.30. "TIMERx PRODUCTION TECHNOLOGY" shall mean TIMERx Technologies'
rights under the TIMERx Technologies Patents and any and all
other patents, patent applications, and other technology
belonging to TIMERx Technologies from time to time during the
term of this Agreement that directly relate to, and are
necessary for the production of, Formulated TIMERx for use in
the Designated Product.
1.31. "TIMERx TECHNOLOGIES PATENTS" shall mean:
1.31.1. those patents, patent applications, and equivalents
(such as supplementary protection certificates) in the
Territory owned by TIMERx Technologies or its Affiliates
in respect of TIMERx and/or Formulated TIMERx required
to give effect to this Agreement and as listed in
Exhibit 1.31 and all divisions, continuations, reissues,
or extensions thereof; and
1.31.2. TIMERx Technologies' rights under patents in the
Territory, if any, obtained and in force during the
License Term covering any of TIMERx Technologies'
improvements, modifications, alterations, or
enhancements to any of the inventions covered by the
TIMERx Technologies Patents. The patent issued in Europe
under No. 0360562 (but currently on appeal) and any
patents in Europe arising therefrom shall be referred to
herein as the "'89 Patent"). The pending patent
application in the EPO filed August 30,1994 as
Application No. 94401925.6 and any patents in Europe
arising therefrom shall be referred to herein as the
"'94 Application/Patent"). The '89 Patent and the '94
Application/Patent are sometimes referred to
collectively herein as the "Principal Patents."
1.32. "TIMERx TECHNOLOGIES TEST AND REGULATORY DATA" shall mean any
and all test data, test designs and protocols, clinical studies
and results thereof, government licenses and applications
therefor, government certifications and findings, and related
materials, information and rights (including without limitation
information regarding bioavailability and bioequivalence, and
any adverse drug reactions), developed, commissioned or
otherwise obtained by TIMERx Technologies or any of its
Affiliates, sublicensees or subcontractors during the term of
this Agreement relating to Formulated TIMERx, Designated
Product, controlled-release nifedipine in 30mg and/or 60mg
dosage strengths,
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TIMERx Technologies Patents, Product Production Technology,
and/or TIMERx Production Technology (to the extent the same are
discloseable by TIMERx Technologies without violation of duties
of confidentiality owed to third parties), together with all
intellectual property and other rights and interests of TIMERx
Technologies and its Affiliates thereto and therein in the
Territory. For the avoidance of doubt Sanofi Test and Regulatory
Data are excluded from this definition.
1.33. "TIMERx TRADEMARK(S)" shall mean those names, symbols and or
characters described in Exhibit 1.33 hereto, as the same may be
amended from time to time during the term of this Agreement by
TIMERx Technologies on at least six (6) months' prior written
notice to Sanofi, that are owned and registered (or are
registrable) by TIMERx Technologies and that have been
designated by it for use in conjunction with Sanofi's packaging
and promotion of the Designated Product hereunder, pursuant to
Section 5.2.
2. GRANT OF LICENSE AND TRANSFER OF TECHNOLOGY.
2.1. TIMERx Technologies hereby grants to Sanofi a license under the
TIMERx Technologies Patents and TIMERx Technologies'
Confidential Technology disclosed to Sanofi hereunder and to all
TIMERx Improvements, to manufacture, use and sell and register
the Designated Product in the Territory during the License Term.
Subject to Section 7.3, such license shall be exclusive for such
purposes in each country during the Exclusivity Period for that
country, and otherwise shall be nonexclusive. TIMERx
Technologies hereby grants to Sanofi a nonexclusive license
under the Product Production Technology to make and have made
the Designated Product in the Territory during the License Term
using Formulated TIMERx supplied by TIMERx Technologies or
produced pursuant to the license under Section 7.6. Such
licenses do not extend to the making of TIMERx or Formulated
TIMERx, those matters being covered by Section 7.6. Sanofi shall
have the right to grant sublicenses of its rights hereunder to
any Affiliate(s) of Sanofi (and this Agreement shall thereby be
binding upon and inure to the benefit of such Affiliate within
the area of such sublicense), but shall otherwise have no right
to grant sublicenses hereunder without the prior written consent
of TIMERx Technologies in its discretion. TIMERx Technologies
will, throughout the License Term, promptly notify Sanofi of all
TIMERx Technologies Patents referred to in Subsection 1.31.2 and
provide Sanofi with access to all of the same and to other
TIMERx Improvements, solely for use within the scope of the
license stated in this section.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
2.2. TIMERx Technologies hereby grants Sanofi a nonexclusive, paid-up
license, with right to sublicense as stated in Section 2.1,
under all rights of TIMERx Technologies and its Affiliates in
and to the TIMERx Technologies Test and Regulatory Data to use
the same for purposes of complying with governmental
requirements, but solely with respect to the Designated Product
for marketing or use in the Territory. TIMERx Technologies
hereby consents to Sanofi's and its permitted sublicensees'
cross-referencing, in any PLA or other governmental filings made
by them within the scope of such license, any ANDA, NDA or other
PLA filing made or drug master file created by TIMERx
Technologies or its Affiliates relating to or containing any of
the TIMERx Technologies Test and Regulatory Data. The license
and rights under this section shall survive any termination or
expiration of the term of this Agreement, except a termination
under Section 11.4 due to an uncured breach by Sanofi. TIMERx
Technologies will, throughout the License Term and solely for
use within the scope of the license stated in this section,
provide to Sanofi on request access to all of the TIMERx
Technologies Test and Regulatory Data in or coming into TIMERx
Technologies' possession or otherwise reasonably available to
it.
2.3. TIMERx Technologies will at its expense exert reasonable efforts
to make knowledgeable personnel reasonably available within
thirty (30) days from the later of the Effective Date or
Sanofi's written request, to consult with Sanofi to the extent
necessary to enable Sanofi to produce Designated Product for
Sanofi and its Affiliates pursuant to this Agreement. The
parties understand and agree that Sanofi's performance under
this Agreement depends upon the communication of the Product
Production Technology, and that, if for any reason, it is not
possible to transfer such technology to Sanofi, this will not
lead to liability on Sanofi's part. The Product Production
Technology will be deemed to have been successfully transferred
upon the satisfactory completion of the Phase II Dissolution
Profile Studies.
3. DEVELOPMENT AND REGULATORY PERIODS.
3.1. In consideration of TIMERx Technologies' entering into this
Agreement, Sanofi shall pay TIMERx Technologies upon the
Effective Date a nonrefundable initial fee of ********.
3.2. During the Development Period, TIMERx Technologies will exert
all its reasonable efforts to complete the Phase I Dissolution
Profile Studies and Sanofi will cooperate in such effort.
********** Phase I Dissolution Profile Studies (as more fully
described in Exhibit 1.9), Sanofi will pay TIMERx Technologies a
milestone fee of **********.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
3.3. During the Development Period, Sanofi will exert all its
reasonable efforts to complete the Phase II Dissolution Profile
Studies as soon as is practicable, and TIMERx Technologies will
cooperate in such effort. ********** Phase II Dissolution
Profile Studies (as more fully described in Exhibit 1.9), Sanofi
will pay TIMERx Technologies a milestone fee of **********.
3.4. Each party's Project Contact(s) will provide written reports to
the other party's Project Contact(s) at least monthly throughout
the Development Period and the Regulatory Period, stating in
detail all efforts made and in process, and all significant
progress achieved and difficulties encountered in the reporting
party's portion of the development effort or regulatory efforts,
as the case may be, since the last such report. Each of the
Project Contacts will also be available throughout the
Development Period and the Regulatory Period to answer any
reasonable questions from the other party's Project Contacts, as
appropriate.
3.5. Sanofi will supply to TIMERx Technologies, without charge, all
Adalat LA and Designated Product reasonably required to support
the development effort by TIMERx Technologies during the
Development Period (other than Designated Product for the Phase
I Dissolution Profile Studies, which shall be supplied by TIMERx
Technologies at its expense), and TIMERx Technologies shall
provide at its own expense all Formulated TIMERx reasonably
required for such effort.
3.6. Throughout the Development Period and the Regulatory Period, the
parties' Project Contacts and other relevant personnel (as
determined in good faith by each party) shall attend project
meetings to be held quarterly or on such other basis as may be
mutually agreed. The sites for such meetings will alternate
between Patterson, N.Y. and Guildford, Surrey (which is the
location of Sanofi's Affiliate, Sanofi Winthrop Limited ("Sanofi
Winthrop"), which will be the Sanofi branch with the closest
relationship to this Agreement). Each party shall bear its own
expenses of its personnel's travel, lodging and meals incurred
in connection with attending such quarterly meetings. Each party
shall bear its own expenses for all activities during the
Development Period and the Regulatory Period, except that, if
TIMERx Technologies personnel travel outside the Patterson, New
York area during the Development Period or the Regulatory Period
at the request of Sanofi and for the convenience of Sanofi,
other than to attend such meetings, Sanofi shall bear all of the
reasonable travel, lodging and meal expenses for such personnel,
and if Sanofi personnel travel outside the Guildford, Surrey
area during the Development Period or the Regulatory Period at
the request of TIMERx Technologies and for the convenience of
TIMERx Technologies, other than to attend such meetings, TIMERx
Technologies
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
shall bear all of the reasonable travel, lodging and meal
expenses for such personnel.
4. OTHER REGULATORY PERIOD PROVISIONS.
4.1. Promptly following approval by Sanofi of the Phase II
Dissolution Profile Study for the Designated Product pursuant to
Section 3.3 above, the Regulatory Period will begin. Sanofi
will, during the Regulatory Period, exert all its reasonable
efforts to perform the ********** and TIMERx Technologies will
cooperate in such effort. As to scheduling, the parties
understand that *************.
4.2. Subject to completion by Sanofi of the **********, Sanofi will
exert all its continuing reasonable efforts to obtain and retain
marketing approval for the Designated Product throughout the
Territory, including, at its expense, the preparation and filing
during and after the Regulatory Period of PLAs for the
Designated Product with the relevant Regulatory Authorities
throughout the Territory, and the prosecution of the same
successfully to the granting of marketing approvals from such
authorities for the Designated Product. As the term is used in
this Section 4, the exertion of all Sanofi's reasonable efforts
will mean that (i) Sanofi will exert on a continuing basis such
reasonable efforts as would be normal for sponsors or applicants
for regulatory approval of drugs under PLAs generally, and (ii)
this project will receive a priority at least as high as any of
Sanofi's other generic drug development efforts (if such a
priority would lead to the exertion of greater efforts than
those described in clause (i)).
4.3. Each party will cooperate with the other throughout the
Regulatory Period and may at its discretion provide to the other
party all information in or coming into its possession or
reasonably available to it which it considers useful to support
the goals of the Regulatory Period. Without prejudice to its
obligations under this Agreement, each party understands and
agrees that the other does not warrant or commit that the
Designated Product will be successfully developed, nor that, if
developed, that it will be successfully registered in any county
or countries, and neither party shall have any liability or
responsibility to the other or to third parties for any such
failure of the development process hereunder.
4.4. In addition to the fees payable in Section 3.1, 3.2, and 3.3,
and in consideration of TIMERx Technologies' entering into this
Agreement, Sanofi agrees to pay TIMERx Technologies the
following non-refundable fees:
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ASTERISKS DENOTE SUCH OMISSIONS
4.4.1 a milestone fee payable within ********** in the
Territory, in the amount of **********; and
4.4.2 another milestone fee, also in the amount of **********,
payable within ********** in the Territory.
4.5. Except as otherwise provided in this Section 4, each party shall
bear its own expenses for all activities during the Regulatory
Period, provided, however that TIMERx Technologies shall provide
to ************, and reasonable quantities of Designated Product
********** for purposes of comparing therewith the Designated
Product manufactured by Sanofi in dissolution profile testing
and finished product quality control testing, and provided
further, however, that Sanofi shall provide at its own expense
all other Designated Product and other materials and
manufacturing and testing services reasonably required to
support the testing and certification effort.
4.6 Except as provided in Section 4.7, Sanofi shall be responsible
for, and hereby agrees to conduct or arrange for, at Sanofi's
expense, all testing and studies during the Regulatory Period,
including as to efficacy, bioavailability, bioequivalence, and
safety and any other necessary testing, in connection with the
development, manufacture and marketing of the Designated
Product, and for compliance with all requirements imposed by any
Regulatory Authority or otherwise by the government of any
country in the Territory with respect to the Designated Product
provided that TIMERx Technologies shall have promptly and
throughout the Regulatory Period provided to Sanofi all
necessary information in or coming into TIMERx Technologies'
possession and available to it in support of the completion of
such testing.
4.7 If one or more Regulatory Authorities, following Sanofi's filing
of a PLA with it or them, require additional tests or studies,
******************************* (i.e., ************), *****
************* shall be borne entirely by Sanofi, within the
context and limits of its agreement hereunder to exert all
reasonable efforts to obtain marketing approval for the
Designated Product.
4.8 It is understood and agreed that the Specifications for
Formulated TIMERx for Designated Product to be sold in the
United Kingdom and outside the United Kingdom shall be the same,
because this will be required for the technically satisfactory
production, regulatory approval, and exploitation of the
Designated Product. Accordingly, in no event will Sanofi permit
the Designated Product to be certified for sale anywhere in the
Territory on any other basis, unless TIMERx Technologies has
consented thereto in writing after detailed consultation
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with Sanofi. It is understood, however, that the Regulatory
Authority in the respective countries of the Territory may
require differing tests and certificates of analysis on the
Formulated TIMERx to be provided hereunder with respect to
Designated Products to be sold in those countries, and in such
event the parties shall agree on how to proceed.
4.9 Sanofi's Project Contacts will provide written reports to TIMERx
Technologies' Project Contacts, as appropriate, at least monthly
throughout the Regulatory Period, stating in detail all efforts
made and in process, and all significant progress achieved and
difficulties encountered in the certification effort since the
last such report. Sanofi's Project Contacts will also be
available throughout the Regulatory Period to answer any
reasonable questions from TIMERx Technologies' Project Contacts,
as appropriate.
5. MARKETING PERIOD.
5.1. Subject to the granting of all necessary governmental approvals
or concurrences to sell the Designated Product, Sanofi hereby
agrees, during the Marketing Period, to use all continuing
reasonable efforts to market and sell the Designated Product
throughout the portion of the Territory for which its sale has
been approved.
5.2 Sanofi will manufacture and package the Designated Product in
accordance will all applicable laws and regulations in the
Territory. Provided that the TIMERx Trademarks remain registered
in the countries listed in Exhibit 1.33, and that TIMERx
Technologies undertakes reasonable efforts to protect and defend
the same in such countries, Sanofi agrees to market the
Designated Product in conjunction with the appropriate TIMERx
Trademark(s), and as provided below in this Section, and in
association, if Sanofi so desires in any country of the
Territory, with a Sanofi Trademark.
5.2.1 Sanofi acknowledges that all TIMERx Trademarks and all
rights therein or registrations thereof, worldwide,
shall belong exclusively to TIMERx Technologies, and
TIMERx Technologies shall use all reasonable efforts to
obtain and maintain registrations for the TIMERx
Trademarks in the countries of the Territory. All use of
the TIMERx Trademarks as contemplated in this Agreement
by Sanofi shall accrue to the benefit of TIMERx
Technologies. Sanofi shall make no use of any of the
TIMERx Trademarks except to identify and promote the
Designated Product as contemplated hereunder for sale in
the Territory. Sanofi shall not continue using the
TIMERx Trademarks after
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termination or expiration of this Agreement, nor after
the removal or alteration of any such TIMERx Trademark
from Exhibit , except to complete sale of reasonable
quantities of inventory of the Designated Product on
hand at the time of termination or expiration, or at the
time of such removal or alteration.
5.2.2 Sanofi shall cooperate with TIMERx Technologies, at
TIMERx Technologies' request and at TIMERx Technologies'
expense, to protect the interest of TIMERx Technologies
in the TIMERx Trademarks, and shall neither attempt to
register nor authorize others to register the TIMERx
Trademarks without the prior written consent of TIMERx
Technologies in each instance. Sanofi shall promptly
inform TIMERx Technologies of any actual or apparent
infringement of any TIMERx Trademarks or other
intellectual properties of TIMERx Technologies which may
come to Sanofi's attention during the term hereof.
5.2.3 Sanofi shall use all appropriate notices of trademark
status of the TIMERx Trademarks, including the "TM"
designation (or the (R) symbol for registered marks), in
all labeling and promotional materials and shall
otherwise conform with all policies and notices of
TIMERx Technologies' rights in the marks and for the
protection of the TIMERx Trademarks, including without
limitation the inclusion of an appropriate footnote
acknowledging the use of the TIMERx Trademark(s) under
license.
5.2.4 Samples of the Designated Product and any advertising,
promotional materials or packaging related thereto shall
be provided by Sanofi to TIMERx Technologies at least
thirty days prior to the first use or sale thereof, and
at other times upon the reasonable written request of
TIMERx Technologies. Sanofi shall use its reasonable
commercial endeavours to present drafts (or their
equivalents) of such items for the written approval of
TIMERx Technologies, which approval shall not be
unreasonably withheld, prior to the initial use thereof
(or, where this is not possible prior to such initial
use, then as soon as possible thereafter). So long as
the TIMERx Trademark is registered in the Territory,
TIMERx Technologies shall have the right to enter into
Sanofi's facilities up to once a year at times agreed by
the parties and/or to take other appropriate methods to
check the quality of the Designated Product manufactured
or offered by Sanofi, from time to time during the term
of this Agreement after reasonable prior notice to
Sanofi. If at any time or times TIMERx Technologies
determines that the quality of the Designated Product
manufactured or offered by Sanofi, or the packaging or
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promotional materials therefor, does not comply with
TIMERx Technologies standards as communicated from time
to time to Sanofi, TIMERx Technologies, at its option
(and as its only remedy as to trademark matters), shall
have the right to suspend or prohibit the use of the
TIMERx Trademark(s), provided that TIMERx Technologies
has given Sanofi a written notice thereof and a period
of 60 days to bring them up to TIMERx Technologies'
standards; provided further, however, that TIMERx
Technologies need not give such opportunity to cure any
deficiency that has been the subject of more than two
such notices on prior occasions during the preceding
twelve months.
5.3. Except for sales to Sanofi or its Affiliates hereunder, and
subject also to the provisions of Section 7.3, TIMERx
Technologies agrees that it shall not directly or indirectly,
during the Exclusivity Period for any country in the Territory,
sell or market the Designated Products or the Formulated TIMERx
(for use in the Designated Product) in such country or knowingly
for export into such country, provided that Sanofi understands
that TIMERx Technologies may not have effective means to control
where the Designated Products or Formulated TIMERx are
ultimately sold or used after being sold by TIMERx Technologies
or its licensees; provided, however, that nothing herein shall,
without any objectively justified reason, require TIMERx
Technologies (i) to refuse to meet unsolicited orders from users
or resellers outside the Territory who would market the
Designated Products or Formulated TIMERx within the Territory or
(ii) to make it difficult for users or resellers to obtain the
Designated Products or Formulated TIMERx in accordance with
applicable law from other resellers within the European Union,
or in particular to prevent users or resellers from obtaining
outside or from putting on the market in the Territory
Designated Products or Formulated TIMERx which have been
lawfully put on the market within the European Union by TIMERx
Technologies, or with its consent.
5.4 Subject to Section 7.3, Sanofi shall have no right to sell the
Designated Products directly or indirectly in or knowingly for
export to any area other than the Territory, and Sanofi hereby
agrees that neither it nor its Affiliates shall do so or attempt
to do so, whether directly or indirectly, provided that TIMERx
Technologies understands that Sanofi may not have effective
control over where the Designated Products are ultimately sold
or used after being sold by Sanofi or its Affiliates; provided,
however, that nothing herein shall, without any objectively
justified reason, require Sanofi or its Affiliates (i) to refuse
to meet unsolicited orders from users or resellers in the
Territory who would market the Designated Products within that
part of the European Union outside of the Territory or (ii) to
make it difficult for users or resellers to obtain the
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Designated Products in accordance with applicable law from other
resellers within the European Union, or in particular to prevent
users or resellers from obtaining outside or from putting on the
market in the Territory Designated Products which have been
lawfully put on the market within the European Union by TIMERx
Technologies, or with its consent.
5.5 In consideration of TIMERx Technologies' entering this Agreement
and of the grant of the licenses by TIMERx Technologies
hereunder, Sanofi hereby agrees to pay to TIMERx Technologies
Royalties equal to ********************************************
***************************************************************
***************************************************************
***************************************************************
************************************************.
5.6 All Royalties payable pursuant to this Agreement shall be due
quarterly within 60 days following the end of each calendar
quarter for Net Sales in such calendar quarter. Each such
payment of Royalties shall be accompanied by a statement of Net
Sales for the quarter and the calculation of Royalties payable
hereunder, including an itemization of the quantities of the two
dosage strengths sold. All Royalties and all other amounts
payable under this Agreement will bear interest at the rate of 1
1/2% per month or the maximum legal rate, whichever is less,
from the date due through the date of payment. Sanofi shall keep
and shall cause its Affiliates to keep complete, true and
accurate records for the purpose of showing the derivation of
all Royalties payable to TIMERx Technologies under this
Agreement. TIMERx Technologies shall have the right to have such
records inspected, copied and audited no more than one a year by
an independent expert during reasonable business hours upon
reasonable prior written notice to Sanofi or any of its
Affiliates, respectively. Any such audit shall be at the expense
of TIMERx Technologies, unless the audit reveals that, with
respect to the period under audit, less than 97% of the
Royalties due to TIMERx Technologies hereunder have been paid,
in which event Sanofi shall pay or reimburse TIMERx Technologies
for the reasonable expenses of such audit, in addition to TIMERx
Technologies' other remedies for such underpayment. The parties
shall reasonably agree from time to time as to whether Royalties
and other amounts payable under this Agreement shall be
collected on a local or centralised basis, provided that the
basis of collection will not reduce the net amounts ultimately
realized by TIMERx Technologies.
5.7 All monies due to TIMERx Technologies under this Agreement shall
be paid in United States Dollars to TIMERx Technologies in
Patterson, New York, USA. ********** 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
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ASTERISKS DENOTE SUCH OMISSIONS
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.
6. SUPPLY OF FORMULATED TIMERx.
6.1. It is understood and agreed that an established source of supply
of the Formulated TIMERx for use in the Designated Product in
accordance with the Specifications will be required for
technically satisfactory exploitation of the rights granted
hereunder. Accordingly, except as provided in Section 6.2, and
subject to the other provisions hereof, TIMERx Technologies will
supply Sanofi and its Affiliates with quantities of Formulated
TIMERx sufficient to meet their reasonable requirements thereof
during the Marketing Period, and Sanofi shall purchase all of
its and its Affiliates' requirements for TIMERx from TIMERx
Technologies during such period. The price for each kilogram of
Formulated TIMERx sold hereunder shall equal the applicable Per-
Kilogram Price multiplied by the kilograms purchased.
************************************************************
**********. If at any time during the term of this Agreement the
value of the French franc depreciates by more than **********
during period of at ********** in comparison to the exchange
rate fixed at the Effective Date, TIMERx Technologies may review
accordingly the price at which the Formulated TIMERx is supplied
to Sanofi.
6.2 If TIMERx Technologies, for reasons of force majeure, fails or
is unable to supply Sanofi with its and its Affiliates'
requirements of Formulated TIMERx during the Marketing Period
pursuant to Section 6.1, TIMERx Technologies shall grant Sanofi
a nonexclusive license to manufacture Formulated TIMERx under
the TIMERx Production Technology, and shall make knowledgeable
personnel available at the expense of TIMERx Technologies (up to
a maximum of ******) to consult with Sanofi, all to the extent
necessary to enable Sanofi to produce Formulated TIMERx (from
the appropriate raw materials) that would otherwise have been
supplied by TIMERx Technologies or an alternate supplier
hereunder for Sanofi and its Affiliates in connection with the
production of the Designated Product pursuant to this Agreement.
TIMERx Technologies will provide as much prior notice to Sanofi
of any failure described in this section as the circumstances
permit. In such event Sanofi shall pay to TIMERx Technologies,
in addition to the Royalties under Section 5.5,****** of
Formulated TIMERx produced, converted to Designated Product and
sold by Sanofi hereunder, *************************************.
6.3 The following provisions shall be applicable to the situation
described in Section 6.2:
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ASTERISKS DENOTE SUCH OMISSIONS
6.3.1 Sanofi shall maintain all information and technology
delivered to Sanofi pursuant to such Section, whether
orally or in writing, in strictest confidence and shall
use such information and technology only for the purpose
of producing the Formulated TIMERx for its own use and
the use of its Affiliates and permitted sublicensees (if
any) in connection with this Agreement.
6.3.2 Sanofi acknowledges that, in doing the foregoing, TIMERx
Technologies will not be providing a "turnkey"
operation. Rather, TIMERx Technologies will only be
required to make available to Sanofi the best standard
of knowledge and information then available to TIMERx
Technologies and directly used in its or its Affiliate's
or licensee's manufacture of the Formulated TIMERx.
TIMERx Technologies will not be required to prepare,
provide or obtain any information not then in its
possession, nor to adapt any of the knowledge or
information provided to the particular plant or
manufacturing location of Sanofi, including without
limitation any local legal, licensing, or environmental
considerations. If any professional licenses, visas, or
other permits are required for any of the consulting to
be provided by TIMERx Technologies' or its Affiliates'
or licensees' personnel, Sanofi shall so inform TIMERx
Technologies and Sanofi shall bear the costs of
obtaining the same.
6.3.3. Without prejudice to TIMERx Technologies' obligations
under this Agreement, neither TIMERx Technologies nor
its Affiliates or licensees will be responsible for any
failure of Sanofi or its personnel to understand or
properly to implement such knowledge and information or
for any materials made by any party other than TIMERx
Technologies or such respective Affiliate or licensee
using such knowledge and information, except where such
failure to understand results from the negligence or
willful misconduct of TIMERx Technologies.
6.3.4. If TIMERx Technologies' non-delivery of the Formulated
TIMERx as described in Section 6.2 resulted in whole or
in part from a temporary inability to produce and
deliver the same, and TIMERx Technologies gives
****************************** that TIMERx Technologies
will again be able and willing to supply the Formulated
TIMERx and demonstrates to Sanofi's reasonable
satisfaction that TIMERx Technologies is so able and
willing to supply the Formulated TIMERx on a long-term
basis, TIMERx Technologies will, upon the agreement of
both parties (which agreement will not be withheld
unreasonably), resume the supply of the Formulated
TIMERx hereunder, it being understood that
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Sanofi will be entitled to exhaust its work in process
and any inventory of Formulated TIMERx ****************
6.4 All sales of Formulated TIMERx hereunder shall be F.O.B.
Patterson, N.Y., and Sanofi shall bear all transportation,
insurance, taxes, duties, and other costs and risks of loss,
spoilage and damage associated with shipping and delivery to
Sanofi or its Affiliates. All payments by Sanofi to TIMERx
Technologies pursuant to this Section 6 will be made in US
dollars within thirty (30) days of receipt by Sanofi of TIMERx
Technologies' invoice, by direct bank transfer to such account
of TIMERx Technologies as TIMERx Technologies shall from time to
time notify Sanofi.
6.5 TIMERx Technologies shall perform routine quality control tests
with respect to all Formulated TIMERx as required by the
applicable Regulatory Authority and any additional quality
control tests as TIMERx Technologies deems necessary in
accordance with its applicable policies. No other or special
tests by TIMERx Technologies will be required, unless and to the
extent that Sanofi establishes that the same are required in
order to obtain or maintain a Regulatory Authority or other
governmental license to market the Designated Product in the
Territory. The parties will reasonably and timely agree in a
separate quality control agreement upon quality control, quality
assurance, and inspection testing procedures and
responsibilities as required by applicable regulations.
6.6 If Sanofi considers any such shipment not to conform to the
applicable Specifications for the Formulated TIMERx, Sanofi
shall notify TIMERx Technologies in accordance with the quality
control agreement referenced in Section 6.5 and provide TIMERx
Technologies with the relevant analysis. TIMERx TECHNOLOGIES'
SOLE OBLIGATION AND SANOFI'S EXCLUSIVE REMEDY FOR ANY SUCH
NONCONFORMITY THAT IS EITHER DETECTED, OR THAT WOULD HAVE BEEN
DETECTABLE THROUGH PROPER APPLICATION OF THE STANDARD QUALITY
CONTROL PROCEDURES IN THE INDUSTRY, SHALL BE AS FOLLOWS:
i) TIMERx Technologies shall at its own expense
accept return, or cause its supplier to accept
return, of any shipment not accepted, or else
reimburse Sanofi for the cost of disposal or
destruction; and
ii) TIMERx Technologies shall replace the
non-conforming shipment as quickly as possible
with conforming Formulated TIMERx and
reconstitute, ******, the inventory of
Formulated TIMERx pursuant to Section 6.9 below.
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6.7 While TIMERx Technologies is supplying Formulated TIMERx
hereunder to Sanofi, TIMERx Technologies shall, after receipt of
reasonable prior notice, give duly accredited representatives of
Sanofi access at all reasonable times during regular business
hours to TIMERx Technologies' or its Affiliate's plant in which
the Formulated TIMERx is being produced, and (if and to the
extent Sanofi establishes that it must have such access in order
to obtain or maintain a Regulatory Authority or other
governmental license to market the Designated Product) to the
plant of any licensee in which the Formulated TIMERx is being
produced, in up to two visits per year. In addition, TIMERx
Technologies will use all its reasonable efforts to obtain the
permission of any such licensee for other access to such
licensee's plant as may be reasonably requested by Sanofi.
6.8 Sanofi shall, within three months following the filing by Sanofi
of each PLA with each Regulatory Authority for the Designated
Product, submit to TIMERx Technologies Sanofi's best estimate of
its requirements for Formulated TIMERx in the six month period
following the later of the Approval Date or the Other
Governmental Approval Date in the applicable country, which
estimates will be subject to firm order pursuant to Section 6.9.
6.9 Sanofi shall deliver to TIMERx Technologies a firm written order
stating its (and/or its Affiliates') requirements for Formulated
TIMERx to be used for production of the Designated Product for
commercial use or sale no less than **** in advance of the
requested delivery date therefor. All such firm orders shall be
non-cancellable by Sanofi. TIMERx Technologies will supply
quantities within **** following receipt of Sanofi's firm
written order therefor. TIMERx Technologies shall have no
obligation to supply Sanofi with quantities during any quarter
in excess of **** of the highest quantity estimated in Sanofi's
estimates for that quarter pursuant to Section 6.10. TIMERx
Technologies, will supply to Sanofi an inventory of ****
production requirements of Formulated TIMERx for Sanofi and its
Affiliates, based on Sanofi's projections given under Section
6.10 for the **** extending beyond the **** firm ordering period
(but not in excess of **** of Sanofi's actual firm order volume
for such firm order period). TIMERx Technologies will bear the
costs of this **** inventory of Formulated TIMERx to be held by
Sanofi at its own storage facilities (at Sanofi's costs and risk
as to storage), by not invoicing Sanofi for the price of such
inventory (unless and until the inventory is finally depleted).
6.10 At least **** before Sanofi and/or its Affiliates begin
commercial sale of the Designated Product, Sanofi shall deliver
to TIMERx Technologies a written, non-binding estimate of all
requirements of Formulated TIMERx
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ASTERISKS DENOTE SUCH OMISSIONS
during the following ****. Sanofi will deliver to TIMERx
Technologies updates to such estimates on or before the first
day of each January, April, July and October thereafter, which
updates may revise estimates previously submitted, and will add
estimates for additional months so that each such estimate
covers the **** period following the end of the firm-order
period (that is, the **** after the month in which such
estimates are made), it being understood, however, that as to
****, Sanofi may give such estimates on an aggregated quarterly
or semi-annual basis.
6.11 Pursuant to the terms of Exhibit 6.11, each party shall promptly
notify the other of any fact, circumstance, condition or
knowledge dealing with TIMERx or the Designated Product of which
the Party becomes aware that bears upon the safety or efficacy
of TIMERx or the Designated Product or as to any adverse drug
reaction (whether or not due to a defect in the Designated
Product or the Formulated TIMERx). Each party shall immediately
notify the other of any inspection or audit relating to TIMERx,
Formulated TIMERx, or the Designated Product by any governmental
regulatory authority in the Territory. If a representative of
the governmental authority takes samples in connection with such
audit or inspection, the parties shall immediately provide each
other, as appropriate, with samples from the same batch. The
party in receipt of such notice will provide the other party
within 72 hours, with copies of all relevant documents, warning
letters and other correspondence and notifications as such other
party may reasonably request. TIMERx Technologies and Sanofi
agree to cooperate with each other during any inspection,
investigation or other inquiry by a Regulatory Authority or
other governmental entity, including providing information
and/or documentation, as requested by the Regulatory Authority,
or other governmental entity. To the extent permissible, TIMERx
Technologies and Sanofi also agree to discuss any responses to
observations or notifications received and to give the other
party an opportunity to comment on any proposed response before
it is made. In the event of disagreement concerning the content
or form of such response, Sanofi shall be responsible for
deciding the appropriate form and content of any response with
respect to any of its cited activities and TIMERx Technologies
shall be responsible for deciding the appropriate form and
content of any response with respect to any of its cited
activities. Each party shall inform the other of all comments
and conclusions received from the governmental authority.
7. OWNERSHIP AND OTHER LICENSES.
7.1. Except as otherwise explicitly licensed or transferred as
provided herein, each party will, as between it and the other
party hereto, retain
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ownership of any and all inventions, copyrights, trade marks,
trade secrets, patent rights and other technology and rights to
the extent conceived or developed by its personnel or
contractors (other than the other party hereto) pursuant to this
Agreement. Neither party makes any grant of rights by
implication. TIMERx Technologies will retain ownership in (but
Sanofi shall have the right to use within the scope of its
licenses) the Phase I Dissolution Profile Studies and Sanofi
will retain ownership (but TIMERx Technologies shall have the
right to use within the scope of, and as limited by, its
licenses thereto under Section 7.8) Sanofi Test and Regulatory
Data and its PLAs.
7.2 Except as otherwise provided herein, each party shall be
responsible, as it shall determine, for the filing and
prosecution of any and all patent applications with respect, in
whole or in part, to its own intellectual property and for the
maintenance of any available patent protection with respect
thereto; provided however, that neither party commits that any
such patent protection will be available or continuous
hereunder, but TIMERx Technologies shall exert, as to the
Territory, all reasonable efforts to secure and to maintain in
force patent protection under the Principal Patents.
7.3 Notwithstanding Section 2.1, Sanofi understands and agrees that
TIMERx Technologies and/or its other licensee(s) may, during the
Exclusivity Period, supply the Designated Product within any
country in the Territory, so long as it does so following the
fifth anniversary of the first time the Designated Product is
put on the market anywhere in the European Union and in response
to unsolicited orders and does not pursue an active policy of
putting the Designated Product on the market in such
country(ies) during the Exclusivity Period. Similarly, Sanofi
will have the right to supply the Designated Product within any
country in the European Union that is not part of the Territory,
so long as it does so in response to unsolicited orders and does
not pursue an active policy of putting the Designated Product on
the market in such country(ies), and so long as it does so
following such fifth anniversary with respect to any areas in
which TIMERx Technologies has at any time granted another entity
distribution rights with respect to the Designated Product.
7.4 Sanofi acknowledges that TIMERx Technologies, for itself and for
others, applies, and will seek to apply, TIMERx to products
other than the Designated Product. No provision hereof, and no
exclusivity hereunder, shall prevent TIMERx Technologies from so
applying TIMERx or Formulated TIMERx, so long as the end product
is not the Designated Product in the Territory hereunder.
7.5 Sanofi hereby grants to TIMERx Technologies a nonexclusive,
paid-up
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ASTERISKS DENOTE SUCH OMISSIONS
license under any and all patents, patent applications, and
other intellectual property rights of any sort in the Territory
owned or controlled and licensable by Sanofi or its Affiliates,
to make, have made, use and sell Formulated TIMERx during the
License Term, if and to the extent such license is necessary for
TIMERx Technologies to do so as agreed hereunder, for the
purposes of manufacturing, having manufactured and supplying the
Formulated TIMERx to Sanofi hereunder, including without
limitation any and all Sanofi Test and Regulatory Data.
7.6 Subject to and conditional upon the failure or continuing
inability of TIMERx Technologies to meet Sanofi's and its
Affiliates' requirements for Formulated TIMERx for reasons of
force majeure as provided in Section 6.2, TIMERx Technologies
grants to Sanofi a nonexclusive license under the TIMERx
Production Technology to make and have made the Formulated
TIMERx during the License Term (subject to Section 6.3.4) solely
for use in manufacturing the Designated Product as permitted
hereunder. Sanofi shall have no right to grant sublicenses of
its rights hereunder except to an Affiliate of Sanofi without
the prior written consent of TIMERx Technologies, in its
discretion.
7.7 Sanofi hereby grants to TIMERx Technologies a nonexclusive,
paid-up, worldwide license, with right to sublicense, under any
and all Sanofi Improvements and any and all patents, patent
applications, trade secrets, copyrights, and other intellectual
property rights of any sort covering the Sanofi Improvements, to
make, have made, use and sell any products or services using or
based upon TIMERx or related technology, other than the
Designated Product in the Territory during the License Term.
Sanofi will, throughout the License Term, promptly notify TIMERx
Technologies of all Sanofi Improvements and provide TIMERx
Technologies with access to all of the same, solely for use
within the scope of the license stated in this section; provided
that the exercise of any patents covering any Sanofi
Improvements shall, except as stated in Section 7.5, require the
payment to Sanofi of a reasonable fee or royalty.
7.8 Sanofi hereby grants TIMERx Technologies a nonexclusive, paid-up
(except as noted below in this section) license, with right to
sublicense, under all rights of Sanofi and its Affiliates in and
to the Sanofi Test and Regulatory Data to use the same for
purposes of complying with regulatory or other governmental
requirements of any country, other than with respect to the
Designated Product for marketing or use in a country in the
Territory during the Exclusivity Period in such country. Such
licensed use of Sanofi Clinical Data shall require prior notice
to Sanofi and its consent thereto, which consent shall not be
unreasonably withheld or delayed, and such license shall also
require ********** so used
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(payable only once hereunder, regardless of the number of uses
or areas involved) if and to the extent any of the Sanofi
Clinical Data is used under this license; provided, however that
no such fee shall be payable if the only use of the Sanofi
Clinical Data is in connection with attempts to secure
regulatory approval for the Designated Product in a country or
countries which were once in the Territory but as to which
Sanofi has, for any reason, abandoned its efforts to secure such
approval. Sanofi hereby agrees to make the Sanofi Test and
Regulatory Data available to TIMERx Technologies which may in
turn make the same available to sublicensees for use by them in
respect of any Abbreviated New Drug Application ("ANDA"), New
Drug Application ("NDA"), PLA, or other governmental filings
made by them within the scope of such license. The license under
this section shall survive any termination or expiration of the
term of this Agreement, except a termination under Section 11.4
due to an uncured breach by TIMERx Technologies. Sanofi will,
throughout the License Term and solely for use within the scope
of the license stated in this section, provide to TIMERx
Technologies on request access to all of the Sanofi Test and
Regulatory Data in or coming into Sanofi's possession or
otherwise reasonably available to it.
7.9 Each party agrees to mark and to have marked by its sublicensees
every product manufactured, used or sold by it or its
sublicensees in accordance with applicable laws relating to the
marking of patented articles with notices of patent.
8. CONFIDENTIALITY.
8.1. In the course of performance under this Agreement or during the
discussions leading thereto, a party may disclose, or may have
disclosed, in writing, orally or by demonstration or sample, to
the other party confidential information belonging to such party
or entrusted to it by a supplier or licensee, which information
is marked or stated in writing at or within 30 days after its
disclosure to be "confidential" or "trade secret" information.
All such confidential information disclosed by a party shall be
maintained in confidence by the other and will not be used by
the other party for any purpose except as authorized hereunder.
Each party shall exercise, and shall cause its Affiliates,
sublicensees, and consultants to exercise, a reasonable degree
of care and at least the same degree of care as it uses to
protect its own confidential information of similar nature to
preserve the confidentiality of such information disclosed by
the other party. Each party shall safeguard such information
against disclosure to third parties, including without
limitation employees and persons working or consulting for such
party that do not have an established, current need to know such
information for purposes authorized under this Agreement. This
obligation of confidentiality does
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not apply to information and material:
8.1.1. that were properly in the possession of the receiving
party, without any restriction on use or disclosure,
prior to receipt from the other party, each party
acknowledging that the other very likely already has
information that is relevant to this Agreement;
8.1.2. that are at the time of disclosure hereunder in the
public domain by public use, publication, or general
knowledge;
8.1.3. that become general or public knowledge through no fault
of the receiving party or its Affiliates following
disclosure hereunder;
8.1.4. that are properly obtained by the receiving party from a
third party not under a confidentiality obligation to
the disclosing party hereto; or
8.1.5. to the extent the same are required to be disclosed by
order of any court or governmental authority; provided,
however, that the receiving party shall use its best
efforts to give the disclosing party prior notice of any
such disclosure so as to afford the disclosing party a
reasonable opportunity to seek, at the expense of the
disclosing party, such protective orders or other relief
as may be available in the circumstances.
8.2 Neither party shall make any public announcement or other
publication regarding this Agreement (whether as to the
existence or terms hereof) or the development work or project
hereunder or the results thereof without the prior, written
consent of the other party, which consent shall not be
unreasonably withheld; provided that the foregoing shall not
prohibit any disclosure which, in the opinion of counsel to the
disclosing party, is required by any applicable law or by any
competent governmental authority. In no event shall either party
make any disclosure of any such results before a patent
application has been filed with respect thereto, except upon the
prior written approval of the other party.
9. INFRINGEMENT.
9.1. TIMERx Technologies shall exert all reasonable efforts to
monitor and to attempt to stop any infringements by third
parties of any patent included within the Principal Patents and
shall promptly inform Sanofi of any such suspected infringements
or of any of the other TIMERx
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Technologies Patents or the infringement or misappropriation of
the Product Production Technology or the TIMERx Production
Technology by a third party of which it becomes aware, to the
extent such infringement involves the manufacture, use or sale
of the Designated Product in a country in the Territory during
the Exclusivity Period for such country ("Covered
Infringement"). Sanofi shall exert reasonable efforts to monitor
the marketplace and shall promptly inform TIMERx Technologies of
any suspected infringement of any of the TIMERx Technologies
Patents or infringement or misappropriation of the Product
Production Technology or the TIMERx Production Technology of
which it becomes aware, whether or not the same involves a
Covered Infringement.
9.2 If the suspected infringement or misappropriation does not
involve a Covered Infringement, TIMERx Technologies may take, or
refrain from taking, any action it chooses, with or without
notice to Sanofi, and Sanofi shall have no right to take any
action with respect to such suspected infringement or
misappropriation, nor to any recoveries with respect thereto. If
the suspected infringement or misappropriation involves a
Covered Infringement, TIMERx Technologies shall, within 120 days
of the first notice referred to in Section 9.1, inform Sanofi
whether or not TIMERx Technologies intends to institute suit
against such third party with respect to a Covered Infringement,
it being understood that any failure of TIMERx Technologies to
bring any such suit shall only lead to the consequences stated
in Section 9.7 if such failure is a breach of TIMERx
Technologies' duty of reasonable efforts stated in Section 9.1.
Sanofi will not take any steps toward instituting suit against
any third party involving a Covered Infringement until TIMERx
Technologies has informed Sanofi of its intention pursuant to
the previous sentence.
9.3 TIMERx Technologies shall notify Sanofi of any suit that it
institutes against a third party with respect to a Covered
Infringement. If Sanofi does not agree to join in such suit as
provided in Section 9.4, TIMERx Technologies may bring such suit
on its own and shall in such event bear all costs of, and shall
exercise all control over, such suit. TIMERx Technologies may,
at its expense, bring such action in the name of Sanofi and/or
cause Sanofi to be joined in the suit as a plaintiff.
Recoveries, if any, whether by judgment, award, decree or
settlement, shall belong solely to TIMERx Technologies.
9.4 If TIMERx Technologies notifies Sanofi that it intends to
institute suit against such third party with respect to a
Covered Infringement together with a description of all of the
material information available to TIMERx Technologies with
respect thereto, and Sanofi notifies TIMERx Technologies within
30 days after receipt of such notice and description
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
that Sanofi desires to institute suit jointly, the suit shall be
brought jointly in the names of both parties and all costs
thereof shall be borne equally. Recoveries, if any, whether by
judgment, award, decree or settlement, shall, after the
reimbursement of each of TIMERx Technologies and Sanofi for its
share of the joint costs in such action, be shared between
TIMERx Technologies and Sanofi equally.
9.5 If TIMERx Technologies notifies Sanofi that it does not intend
to institute suit against such third party with respect to a
Covered Infringement, Sanofi may institute suit on its own.
***************************************************************
**************************************************************
**************************************************************
***************************************************************
****************** substantial relief, whether in the form of an
injunction, a declaration that the third party was infringing,
or in the form of damages in excess of Sanofi's costs incurred
in connection with such suit. Otherwise, Sanofi may ****** as
such reimbursements. Recoveries, if any, whether by judgment,
award, decree or settlement covered by this section, shall
belong solely to Sanofi.
9.6 Should either TIMERx Technologies or Sanofi commence a suit
under the provisions of this Section 9 and thereafter elect to
abandon the same, it shall give timely notice to the other
party, who may, if it so desires, be joined as a plaintiff in
the suit (or continue as such if it is already one) and continue
prosecution of such suit, provided, however, that the sharing of
expenses and any recovery of such suit shall be as agreed upon
between TIMERx Technologies and Sanofi.
9.7 In no event shall Sanofi's monetary remedies for any breaches or
deficiencies in TIMERx Technologies' performance of its
obligations under this Section 9 or under Section 7.2,
regardless of the number or severity thereof, exceed the rebate
of one-third of the Royalties that would otherwise be due to
TIMERx Technologies under Section 5.5 with respect to Net Sales
made in or to the country or countries to which such breaches or
deficiencies relate, unless such breaches or deficiencies lead
to a result described in Exhibit 5.5 , in which case that
Exhibit shall apply as stated in Section 5.5.
10. REPRESENTATIONS, WARRANTIES AND INDEMNITIES.
10.1. Each party represents and warrants to the other that, to the
best of its current knowledge, it has the full right and
authority to enter into this Agreement and to grant the licenses
granted herein.
10.2 TIMERx Technologies represents and warrants that it or its
Affiliates are the beneficial owner of the TIMERx Technologies
Patents, the TIMERx Trademarks, and the TIMERx Production
Technology, and that it is duly
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
authorized to grant license rights to Sanofi thereunder, and
under the Product Production Technology, pursuant to this
Agreement. TIMERx Technologies represents and warrants that the
Designated Product is within one or more claims of the TIMERx
Technologies Patents.
10.3 TIMERx Technologies represents and warrants that the
Specifications for the Designated Product describe a Designated
Product which:
10.3.1. to the extent of TIMERx Technologies' current knowledge,
will not infringe upon the intellectual property rights
of any third party, nor, to such knowledge of TIMERx
Technologies, will the registration, manufacture, sale
or promotion of such Designated Product so infringe; and
10.3.2 will not infringe upon the patents in the Territory of
any third party which were issued or published prior to
September 19, 1989 and which disclose an oral tablet,
time-release form of nifedipine dosage or delivery
system, other than: (i)**********; or (ii) **********.
10.4 TIMERx Technologies represents and warrants that (i) the
Formulated TIMERx to be supplied by it to Sanofi hereunder shall
conform to the Specifications therefor at the point of delivery;
(ii) the Designated Product to be manufactured by Mylan
Pharmaceuticals and to be used by TIMERx Technologies in the
Phase I Dissolution Profile Studies shall conform to the
Specifications for the Designated Product when so used; and
(iii) the Designated Product to be manufactured by Mylan
Pharmaceuticals and to be provided to Sanofi by TIMERx
Technologies pursuant to Section 4.5 shall conform to the
Specifications when so provided.
10.5 In no event shall Sanofi's monetary remedies or TIMERx
Technologies' damages for any breaches of TIMERx Technologies'
obligations under Section 10.3.2, regardless of the number or
severity thereof, exceed the rebate of the Royalties theretofore
paid to TIMERx Technologies under Section 5.5 with respect to
Net Sales made in or to the country or countries to which such
breaches relate.
10.6 TIMERx Technologies represents and warrants that it has, or has
access to, annual manufacturing capability to manufacture
quantities of the Formulated TIMERx at least equivalent to the
quantities required for Sanofi to produce quantities of the
Designated Product sufficient to meet ******, as stated in
Exhibit 11.2.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
10.7 TIMERx Technologies represents and warrants to Sanofi that it
has obtained, and will at all times during the term of this
Agreement hold and comply with, all licenses, permits and
authorizations necessary to perform this Agreement and to test,
manufacture, market, and export the Formulated TIMERx as now or
hereafter required under any applicable statutes, laws,
ordinances, rules and regulations of the United States. Sanofi
represents and warrants to TIMERx Technologies that it has
obtained, and will at all times during the term of this
Agreement hold and comply with, all licenses, permits and
authorizations necessary to perform this Agreement and to test,
manufacture, market, export the Designated Product or Formulated
TIMERx in the Territory, and to import Formulated TIMERx into
the Territory from the United States, as now or hereafter
required under any applicable statutes, laws, ordinances, rules
and regulations of any applicable governments and governmental
entities in the Territory.
10.8 THE FOREGOING WARRANTIES IN THIS SECTION 10 ARE IN LIEU OF, AND
THE PARTIES EACH DISCLAIM, ALL OTHER WARRANTIES, EXPRESS,
IMPLIED OR ARISING BY LAW, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY,
FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. NOTHING
IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION OR
WARRANTY (i) BY TIMERx TECHNOLOGIES AS TO THE PATENTABILITY,
VALIDITY, OR SCOPE OF ANY TIMERx TECHNOLOGIES PATENTS, TIMERx
TECHNOLOGIES' CONFIDENTIAL TECHNOLOGY, TIMERx IMPROVEMENTS,
PRODUCT PRODUCTION TECHNOLOGY, TIMERx PRODUCTION TECHNOLOGY, OR
TIMERx TECHNOLOGIES TEST AND REGULATORY DATA, NOR AS TO THE
UTILITY, EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF
TIMERx OR THE DESIGNATED PRODUCT; OR (ii) BY SANOFI AS TO THE
PATENTABILITY, VALIDITY, OR SCOPE OF ANY SANOFI IMPROVEMENTS OR
SANOFI TEST AND REGULATORY DATA, NOR AS TO THE UTILITY,
EFFICACY, NONTOXICITY, SAFETY OR APPROPRIATENESS OF ANY PRODUCTS
MADE THEREFROM.
10.9 TIMERx Technologies shall indemnify, defend and hold Sanofi and
its Affiliates and sublicensees harmless from any and all
third-party claims to the extent arising from, in connection
with, based upon, by reason of, or relating in any way to:
10.9.1. *******************************************************
***** Product;
10.9.2. a breach of TIMERx Technologies' warranty under Section
10.1,
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10.2 or 10.3.1;
10.9.3. a breach of TIMERx Technologies' warranty under Section
10.6, except as otherwise provided in Section 6.2, in
the circumstances there stated;
10.9.4. any failure of the Formulated TIMERx manufactured by
TIMERx Technologies or its alternate supplier (but not
by Sanofi under Section 6.2), as delivered to Sanofi
hereunder to conform to the applicable Specifications or
the negligent or defective manufacture by TIMERx
Technologies of the Formulated TIMERx; or
10.9.5 any failure of TIMERx Technologies to comply with its
obligation under Section 6.11 to notify Sanofi of any
information coming into TIMERx Technologies' possession
and bearing on the safety of TIMERx or the Designated
Product, and not arising from any other aspect of the
Designated Product or its formulation, development,
supply, production, manufacture, sale, delivery,
distribution or use, nor from any act or omission of
Sanofi with respect to the Designated Product or with
respect to any Formulated TIMERx following its delivery
to Sanofi hereunder. TIMERx Technologies shall also
indemnify, defend and hold Sanofi and its Affiliates and
sublicensees harmless from any and all third-party
claims to the extent arising from, in connection with,
based upon, by reason of, or relating in any way to a
breach of TIMERx Technologies' warranty under Section
10.3.2 (subject, however to Section 10.5), provided,
however, that if TIMERx Technologies reasonably believes
that it may have committed any such breaches, it may at
its election terminate the License Term upon thirty (30)
days' notice to Sanofi with respect to any Designated
Product with respect to sales thereof that could add to
the size of its exposure under Section 10.5; provided,
however, that if TIMERx Technologies so terminates the
License Term under this sentence, Sanofi's remedies will
not be limited by Section 10.5 as to claims arising
from, in connection with, based upon, by reason of, or
relating in any way to, such situation.
10.10 Sanofi shall indemnify, defend and hold TIMERx Technologies
harmless from any and all third-party claims to the extent
arising from, in connection with, based upon, by reason of, or
relating in any way to: (i) the supply, registration,
production, manufacture, sale, delivery, distribution or use of
the Designated Product, except for any matters which are covered
by TIMERx Technologies' indemnities under Section 10.9; (ii) a
breach of Sanofi's warranty under Section 10.1; or (iii) any
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failure of Sanofi to comply with its obligation under Section
6.11 to notify TIMERx Technologies of any information coming
into Sanofi's possession and bearing on the safety of TIMERx or
the Designated Product.
10.11 Notwithstanding anything to the contrary set forth elsewhere
herein, neither Sanofi nor TIMERx Technologies shall be
obligated to indemnify the other party for claims or liabilities
to the extent arising from such other party's negligence,
intentional misconduct, or breach of its duties, obligations,
warranties or representations set forth herein or those of its
Affiliates, sublicensees or assigns.
10.12 Whenever indemnification is provided for a party under this
Agreement, such right of indemnification shall extend also to
the indemnified party's Affiliates, officers, directors,
shareholders, successors, assigns, agents, employees, and
insurers to the extent the same become subject to such claim in
such capacity. The party seeking indemnification shall provide
the indemnifying party with written notice of any claim or
action within ten (10) days of its receipt thereof, and shall
afford the indemnifying party the right to control the defense
and settlement of such claim or action. The party seeking
indemnification shall provide reasonable assistance to the
indemnifying party in the defense of such claim or action. If
the defendants in any such action include both Sanofi and TIMERx
Technologies and either party concludes that there may be legal
defenses available to it which are different from, additional
to, or inconsistent with, those available to the other, that
party shall have the right to select separate counsel to
participate in the defense of such action on its behalf, and
such party shall thereafter bear the cost and expense of such
separate defense. Should the indemnifying party determine not to
defend such claim or action, the other party shall have the
right to maintain the defense of such claim or action and the
indemnifying party agrees to provide reasonable assistance to it
in the defense of such claim or action. Neither party shall
settle any such claim or action in a way that prejudices or
adversely impacts the other party to this Agreement without the
prior approval of such other party (which approval shall not be
unreasonably withheld).
10.13 NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS
AGREEMENT (OTHER THAN SECTION 8, SECTION 9.7, SECTION 10.5,
SECTION 10.9, AND SECTION 10.10), NEITHER PARTY SHALL UNDER ANY
CIRCUMSTANCES BE LIABLE FOR CLAIMS FOR ANY INCIDENTAL,
CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES, INCLUDING ANY LOST
PROFITS OR SAVINGS, ARISING FROM ANY BREACH OF WARRANTY OR THE
PERFORMANCE OR BREACH OF ANY PROVISION OF THIS
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
AGREEMENT OR THE USE OR INABILITY TO USE TIMERx, THE DESIGNATED
PRODUCT, TIMERx TECHNOLOGIES PATENTS, TIMERx TECHNOLOGIES'
CONFIDENTIAL TECHNOLOGY, PRODUCT PRODUCTION TECHNOLOGY, TIMERx
PRODUCTION TECHNOLOGY, TIMERx TECHNOLOGIES TEST AND REGULATORY
DATA, SANOFI IMPROVEMENTS, OR SANOFI TEST AND REGULATORY DATA.
11. TERM AND TERMINATION.
11.1 The term of this Agreement shall begin on the date set forth
above and shall, unless earlier terminated as provided herein,
continue until the end of the License Term.
11.2 TIMERx Technologies may at its option transform the Exclusivity
Period in a country (or group of countries, as so designated in
Exhibit 11.2) into a period for the balance of the License Term,
in which Sanofi's rights will be nonexclusive, if Sanofi fails
to sell at least the minimum sales volumes stated in Exhibit
11.2 in such country or group (as indicated in Exhibit 11.2),
for any of the periods stated. Such option shall be exercised by
TIMERx Technologies, if at all, by written notice to Sanofi
given during the 120 days following TIMERx Technologies' receipt
of Sanofi's report of sales indicating that any such minimum
sales volume was not met during the applicable period.
11.3 If Sanofi fails to meet at least ***** of the minimum sales
volumes specified in Exhibit 11.2 with respect to any country or
group of countries (as indicated in Exhibit 11.2) for any of the
periods stated in such Exhibit, TIMERx Technologies may at its
option elect to terminate the Marketing Period and the License
Term with respect to that country or group upon the delivery of
written notice to Sanofi, delivered on or prior to the 90th day
after the later of the end of such period or TIMERx
Technologies' receipt of a report from Sanofi reporting such
failure.
11.4 In the event that either party materially breaches any of the
terms, conditions or agreements contained in this Agreement to
be kept, observed or performed by it, then the other party may
terminate this Agreement, at its option and without prejudice to
any of its other legal or equitable rights or remedies, by
giving the party who committed the breach (i) in the case of
breach of obligations other than the payment of money, 60 days'
notice in writing, unless the notified party within such 60-day
period shall have cured the breach, and (ii) in the case of
breach of an obligation for the payment of money, 20 days'
notice in writing, unless the notified party within such 20-day
period shall have cured the
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breach, including any required payment of interest on previously
unpaid amounts as set forth herein.
11.5 This Agreement will automatically terminate if either party
files for protection under applicable bankruptcy laws, becomes
insolvent, makes an assignment for the benefit of creditors,
appoints or suffers appointment of a receiver or trustee over
its property, files a petition under any bankruptcy or
insolvency act or has such petition filed against it.
11.6 Any sublicenses granted by Sanofi under this Agreement shall
provide for termination or assignment to TIMERx Technologies, at
the option of TIMERx Technologies, of Sanofi's interest therein
upon termination of this Agreement.
11.7 Following any expiration or termination of the License Term, or
of the Exclusivity Period in any country, the license to TIMERx
Technologies under Section 7.8 shall be thereafter extended to
include (in addition to its coverage as stated in such section)
the use of Sanofi Test and Regulatory Data for purposes of
complying with governmental requirements with respect to the
Designated Product for marketing or use in the Territory, or in
such country as to which the Exclusivity Period has expired or
terminated.
11.8 Sanofi's obligations regarding payment of Royalties accrued as
of the date of termination, TIMERx Technologies' rights under
Sections 7.7 and 7.8 (except if this Agreement is terminated due
to an uncured breach on the part of TIMERx Technologies), and
Sanofi's rights under Section 2.2 (except if this Agreement is
terminated due to an uncured breach on the part of Sanofi), and
the provisions of Sections 8, 10, and 12, hereof shall survive
any expiration or termination of this Agreement.
12. MISCELLANEOUS.
12.1. This Agreement incorporates the Exhibits referenced herein. This
Agreement constitutes the entire agreement and supersedes all
prior agreements and understandings, both written and oral,
between the parties hereto with respect to the subject matter
hereof.
12.2 This Agreement shall be binding upon and inure to the benefit of
the parties hereto and their successors and permitted assigns;
provided, however, that except as part of the transfer of all or
substantially all assets (which, as to TIMERx Technologies,
shall refer to the assets of its division of Penwest, Ltd.) to a
single buyer or pursuant to a merger or
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other corporate reorganization (other than a sale by either
party to Bayer or Pfizer or any of their affiliates):
12.2.1 TIMERx Technologies shall not delegate or subcontract
any of its obligations during the Development Period,
and
12.2.2 Sanofi shall not assign or delegate its rights or
obligations hereunder at any time, without the prior
written consent of the other party hereto.
Notwithstanding the foregoing, either party may assign
or delegate all or part of its rights and obligations
hereunder to its Affiliates without the prior written
consent of the other party (but such assignment or
delegation shall require that the other party be given
notice thereof).
12.3. All notices, requests or other communication provided for or
permitted hereunder shall be given in writing and shall be hand
delivered or sent by facsimile, reputable courier or by
registered or certified mail, postage prepaid, return receipt
requested, to the address set forth on the signature page of
this Agreement, or to such other address as either party may
inform the other of in writing. Notices will be deemed delivered
on the earliest of transmission by facsimile, actual receipt or
three days after mailing as set forth herein.
12.4 Any terms of this Agreement may be amended, modified or waived
only in a writing signed by both parties.
12.5 If any provision of this Agreement shall be held invalid,
illegal or unenforceable, such provision shall be enforced to
the maximum extent permitted by law and the parties' fundamental
intentions hereunder, and the remaining provisions shall not be
affected or impaired.
12.6 Nothing herein contained shall constitute this a joint venture
agreement or constitute either party as the partner, principal
or agent of the other, this being an Agreement between
independent contracting entities. Neither party shall have the
authority to bind the other in any respect whatsoever. Except as
provided herein, nothing contained in this Agreement shall be
construed as conferring any right on either party to use any
name, trade name, trademark or other designation of the other
party hereto, unless the express, written permission of such
other party has been obtained.
12.7 In the event that either party hereto is prevented from carrying
out its obligations under this Agreement by events beyond its
reasonable
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control, including without limitation acts of God or government,
natural disasters or storms, fire, political strife, labor
disputes, failure or delay of transportation, default by
suppliers or unavailability of parts, then such party's
performance of its obligations hereunder shall be excused during
the period of such event and for a reasonable period of recovery
thereafter, and the time for performance of such obligations
shall be automatically extended for a period of time equal to
the duration of such event or events; provided, however, that
the other party may, at its election, terminate this Agreement
upon 120 days' prior notice to the party affected by such
events, unless such events cease to prevent such affected
party's performance hereunder during such 120-day period.
12.8 This Agreement shall be governed by, and construed and enforced
in accordance with, the laws of England without regard to its
conflict of laws rules.
12.9 Any dispute or difference, other than a question relating to
patent validity, between the parties arising out of or in
connection with this Agreement shall be resolved by arbitration
conducted in the English language in London, England before a
panel of three arbitrators under the administration and
then-current rules of the London Court of International
Arbitration, or other rules or administration as the parties may
agree. The arbitrators shall apply to the merits of the dispute
or claim the provisions of this Agreement, and in case of
silence of such provisions, the laws of England. The prevailing
party in any such proceeding shall be entitled to an award of
its reasonable attorneys' fees and other costs, including the
fees and expenses of the arbitrators and the London Court of
International Arbitration, provided that the same may be
apportioned between the parties by the arbitrators if they
determine that each party has prevailed in part. The arbitral
award shall be binding and conclusive on both parties and may be
enforced in any court of competent jurisdiction. Notwithstanding
the foregoing, either party may, on good cause shown, seek a
temporary restraining order and/or a preliminary injunction from
a court of competent jurisdiction, to be effective pending the
institution of the arbitration process and the deliberation and
award of the arbitration panel.
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IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
officers to execute and acknowledge this Agreement as of the date first written
above.
SANOFI WINTHROP TIMERx TECHNOLOGIES
INTERNATIONAL S.A.
By /s/ C. Perol, Jr. By /s/ John V. Talley, Jr.
---------------------------- -------------------------
Head of Corporate Its President
Address: Address:
9 rue du President Salvador Allende 2981 Route 22
94250 Gentilly, France Patterson, N.Y. 12563
FAX: ____________________ FAX: (914) 878-3420
Attn: Directeur Juridique Attn: John V. Talley, Jr.
cc: PENWEST, LTD.
777 - 108th Ave. N.E.,
Suite 2390
Bellevue, WA 98004-5193
Attn: General Counsel
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EXHIBIT 1.9
Dissolution Profile Studies Design
Phase I:
Representative samples of Adalat LA or equivalent from the Territory will be
provided by Sanofi to TIMERx Technologies for in vitro dissolution testing (USP
Type III - 30% PEG - 15cpm). The studies will be completed and these data will
be provided to Sanofi by TIMERx Technologies within thirty days after receipt of
such representative samples from all of the countries in the Territory.
Phase II:
Sanofi will conduct similar studies in the UK, using Designated Product
manufactured by Sanofi and samples of Adalat LA or equivalent from the
Territory.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 1.17
Pivotal Pharmacodynamic Studies
[CONFIDENTIAL:]
Pharmacokinetic Study
********** study comparing the ********** . The actual treatments compared will
be ********** . The study is likely to be performed in a hospital in the area of
Newcastle upon Tyne, England, under the control of Sanofi Winthrop.
Clinical Study
********** comparing the ********** . There will be ********** . Patients will
then receive ********** . The study is likely to be conducted by an independent
Clinical Research Organization under the control of Sanofi Winthrop.
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 1.26A
Specifications for Designated Product
CONFIDENTIAL
NIFEDIPINE
EXTENDED-RELEASE TABLETS
30 MG
I. DESCRIPTION
A brown film-coated, 3/8" round, biconvex beveled edge tablet with "M"
imprinted on one side in black ink. **********
Each Tablet contains **********
II. TESTS
A. IDENTIFICATION -**********
B. DRUG RELEASE -**********
C. UNIFORMITY OF DOSAGE UNITS -********** Conforms to USP
criteria for compressed tablets.
D. ASSAY -**********
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CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 1.26A CONTINUED
CONFIDENTIAL NIFEDIPINE EXTENDED-RELEASE TABLETS
60 MG: TENTATIVE SPECIFICATIONS
SPECIFICATION #: SPEC. 94T019D-01:0.0
PRODUCT NAME: TIMERxO Nifedipine XL 60mg Tablets
MASTER FORMULA #: 94T019D-01:0
TEST SPECIFICATIONS
- ---- --------------
GRANULATION:
BLEND UNIFORMITY ********** .
CORES:
- -----
APPEARANCE Glossy red round biconvex tablets.
HARDNESS **********
COATED TABLETS:
APPEARANCE Round red biconvex tablets.
IDENTIFICATION **********
UNIFORMITY OF DOSAGE UNITS **********
ASSAY **********
RELATED COMPOUNDS
**********
DISSOLUTION **********
(1) British Pharmacopeia **********
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ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 1.26B
Specifications for Formulated TIMERx
CONFIDENTIAL
SPECIFICATION #: SPEC. 32001.2
PRODUCT: TIMERx(R)-N
INVENTORY#: 32001
TEST METHOD SPECIFICATIONS
APPEARANCE ********** Off-white free flowing granules
IDENTIFICATION ********** Forms firm, rubbery gel
VISCOSITY ********** **********
pH ********** **********
LOSS ON DRYING ********** **********
LOOSE DENSITY ********** **********
(BULK DENSITY)
TAPPED DENSITY ********** **********
AVERAGE PARTICLE SIZE ********** **********
MICROBIAL LIMIT TEST **********
Total plate count **********
Pathogens **********
********** NMT 500/g
(1) EC specification **********
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EXHIBIT 1.31
TIMERx Technologies Patents
"Directly Compressible Sustained Release Excipient", issued as EP patent No.
0360562, subject to opposition proceeding (patent upheld by EPO Opposition
Division -- now under appeal).
Pending Patent in Ireland, entitled "Directly Compressible Sustained Release
Excipient", filed September 18, 1989 as Application No. 2968/89.
Pending Patent in EPO, entitled "Sustained Release Heterodisperse Hydrogel
Systems for Insoluble Drugs", filed August 30, 1994 as Application No.
94401925.6.
PCT filing entitled "Sustained Release Excipient", filed in US/PCT March 21,
1995 under number PCT/US95/03825.
Pending Patent in EPO, entitled "Sustained Release Excipient", filed April 21,
1995 as Application No. 95914917.0.
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EXHIBIT 1.33
Trademarks
TIMERx(R) Oral Delivery System
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ASTERISKS DENOTE SUCH OMISSIONS
Exhibit 5.5
**********
I. The Royalties otherwise provided for in Section 5.5********** of the
Designated Product made in a country ********** :
(1) ***********************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
Following the expiration of patent protection for all claims *****************
(2) ***********************************************************************
********************************************************************************
********************************************************************************
********************************************************************************
Following the expiration of patent protection for all claims *****************
is on the market in such country.
(3) Following the *********************************************************
*******************************************************************************
*******************************************************************************
********************************************************************************
********************************************************************************
For purposes of the foregoing "Competing Generic Product" shall mean a drug that
meets all of the following criteria: (A) it is a 30mg or 60mg (as applicable)
once-a-day form of nifedipine considered substitutable for Adalat LA; (B) it has
been fully approved for commercial sale in oral solid-dosage form for
administration in humans by the relevant Regulatory Authority(ies) and has
received all required Other Governmental Approval(s) in such country; (C) it is
not marketed in such country under the brand "Adalat" or "Adalat LA"; and (D) it
is not marketed or co-marketed by Sanofi, any of its Affiliates, or under a
license or sublicense or other arrangement from or with Sanofi or its Affiliates
or sublicensees in any tier.
II. If all claims ********** country, or if issued as a patent in such
country, **********************************************************************
*******************************************************************************
********************************************************************************
********************************************************************************
*******************************************************************************
*******************************************************************************
********************************************************************************
********************************************************************************
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EXHIBIT 6.11
Pharmacovigilance and other Regulatory Reporting Requirements
PROCEDURES FOR PHARMACOVIGILANCE
SANOFI WINTHROP PROCEDURES FOR PHARMACOVIGILANCE
INTRODUCTION
The purpose of these procedures is to confirm the pharmacovigilance
responsibilities of Sanofi and TIMERx with respect of the marketing of the
Product in the UK.
CONTACT WITH THE MCA
Sanofi shall be responsible for all contact with the MCA regarding safety
issues. The contact name from SANOFI for this purpose will be the Medical
Director.
DEFINITIONS
Adverse Event (ADE) Any untoward medical occurrence in a patient or clinical
investigation subject administered a medicinal product
which does not necessarily have a causal relationship
with this treatment.
Adverse Reaction (ADR) An event which is harmful and unintended and where a
relationship with a medicinal product cannot be
excluded.
Serious An adverse event/reaction that :
a. is fatal or immediately life threatening
b. is incapacitating
c. results in permanent or significant disability or
d. requires or prolongs hospitalisation
e. requires medical or surgical intervention to present
those mentioned above (a, b, c, d)
f. congenital anomaly.
Labelled Consistent with the SPC for the Product
Unlabelled Inconsistent with SPC for the Product
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SAE Serious Adverse Event
MINIMUM DETAILS REQUIRED FOR AN ADR REPORT
There are : Suspected drug
Details of suspected reaction
Specific patient with at least one of the
following known (sex, age/dob, identifier, lab test,
patient history)
Identifiable health care professional source
(doctor, dentist, coroner, pharmacist or nurse).
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1. PROVISION OF ADR/ADE REPORTS TO THE MCA BY SANOFI WINTHROP UK
- --------------------------------------------------------------------------------------------------------------------------
Timeframe from date
Country of Type of receipt1 by Sanofi Format Method
Origin Winthrop UK
(calendar Days)
- --------------------------------------------------------------------------------------------------------------------------
Confirmed2 Spontaneous ADR UK All Serious 15 CSM form Post
Reports 3,4,5 EEC All Serious 56 CIOMS I Post
Non EEC Serious & Unexpected 56 CIOMS I Post
Published Case Reports of ADRs 2,3,4 UK All Serious 30 CSM form Post
EEC All Serious 56 CIOMS I Post
Non EEC Serious & Unexpected 56 CIOMS I Post
- --------------------------------------------------------------------------------------------------------------------------
Post Authorisation Studies UK All Serious Events* 15 CSM form Post
EEC All Serious Events* 56 CIOMS I Post
Non EEC All Serious Events* 56 CIOMS I Post
(*excluding unrelated)
- --------------------------------------------------------------------------------------------------------------------------
1 Date of receipt of minimum details for reporting an ADR
2 Confirmed by identifiable health care professional
3 Minimum details for an ADR report
4 Possible causal association will be assumed unless specifically stated as
unrelated/excluded by reporter
5 If reporter states unrelated, report does not meet criteria for an ADR,
unless Pharmacovigilance disagrees
6 In order to comply with "the 15 days" rule to the MCA, from receipt within
the company Worldwide.
- --------------------------------------------------------------------------------
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2. PROVISION OF UK ADR/ADE INFORMATION TO TIMERx TECHNOLOGIES BY SANOFI
WINTHROP UK
- ------------------------------------------------------------------------------------------------------------------------------
Timeframe from date
Country of Type of receipt1 by Sanofi Format Method
Origin Winthrop UK
(calendar Days)
- ------------------------------------------------------------------------------------------------------------------------------
Confirmed2 Spontaneous ADR UK Serious 5 CSM form Fax & Post
Reports 3,4,5 UK Non-Serious 60 IRF Fax & Post
Published Case Reports submitted to UK Serious 30 CSM form Post
MCA
- ------------------------------------------------------------------------------------------------------------------------------
Post Authorisation Studies UK Serious adverse effects 5 CSM form Fax & Post
(excluding unrelated)
- ------------------------------------------------------------------------------------------------------------------------------
ASPPs received from MCA6 UK Serious 30 ASPP Post
- ------------------------------------------------------------------------------------------------------------------------------
1 Date of receipt of minimum details for reporting an ADR
2 Confirmed by identifiable health care professional
3 Minimum details for an ADR report
4 Possible causal association will be assumed unless specifically stated as
unrelated/excluded by reporter
5 If reporter states unrelated, report does not meet criteria for an ADR,
unless Pharmacovigilance disagrees
6 ASPP (Anonymised Single Patient Print) represents spontaneous ADR sent
directly to MCA by doctor, dentist or coroner
- --------------------------------------------------------------------------------
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3. RECEIPT OF SAFETY INFORMATION BY SANOFI WINTHROP UK FROM TIMERx TECHNOLOGIES
- ----------------------------------------------------------------------------------------------------------------------
Timeframe from date
Country of Type of receipt1 by Sanofi Format Method
Origin Winthrop UK
(calendar Days)
- ----------------------------------------------------------------------------------------------------------------------
Spontaneous ADR Reports All Serious 10 CIOMS I Post1
Published ADR Case Reports All Serious 10 CIOMS I Post1
- ----------------------------------------------------------------------------------------------------------------------
Post Authorisation Studies All Serious adverse 10 CIOMS I Post1
effects Events
(excluding unrelated)
- ----------------------------------------------------------------------------------------------------------------------
Periodic Safety Updates (PSU) All 3See below 60 PSU2 Post
(of data lock) (CIOMS II)
- ----------------------------------------------------------------------------------------------------------------------
1 Only by fax if 10 day time frame cannot be met by post.
2 Every 5 years based on international birthdate or at specific request of MCA.
If newly registered, every 6 months for 24 months and then annually for 3
years until renewal.
3 Content and format as described in Notice to Applicants, Chapter V - Section
3, Periodic Safety Update Reports.
- --------------------------------------------------------------------------------
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ASTERISKS DENOTE SUCH OMISSIONS
EXHIBIT 11.2
Minimum **********
Minima are stated below **********
and refer to the **********
in each country or group of countries
Time periods are measured from first day of the
Marketing Period in the country (or, where a group of
countries is listed below,
from the first day of the Marketing Period in any country in such group)
COUNTRY OR GROUP FIRST YEAR SECOND YEAR THIRD YEAR
- ---------------- ---------- ----------- ----------
********** ********** 120 175
********** ********** 1,540 2,320
********** ********** 220 335
********** ********** 2,150 2,300
(which shall for purposes
hereof be a group of countries)
Minima for the Fourth Year and each subsequent year in each country or group
shall equal the higher of (i) the number stated above for the Third Year or (ii)
********************************************************************************
**********.
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THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS
AMENDMENT NO. 1 TO THE PRODUCT DEVELOPMENT, LICENSE AND
SUPPLY AGREEMENT OF 28 FEBRUARY 1997 BETWEEN SANOFI WINTHROP
INTERNATIONAL AND TIMERx TECHNOLOGIES
BETWEEN
TIMERx Technologies, a division of Penwest Ltd., a Washington corporation, with
principal place of business at 2981 Route 22, Patterson, New York 12563, USA.
(hereinafter referred to as TIMERx Technologies)
AND
SANOFI WINTHROP INTERNATIONAL, a company incorporated under the laws of France,
with registered office at 9 rue du President Salvador Allende, 94250, Gentilly,
France.
(hereinafter referred to as Sanofi)
TIMERx Technologies and Sanofi are defined hereinafter as the Parties.
WITNESSETH
WHEREAS, TIMERx Technologies and Sanofi entered into a Product Development,
License and Supply Agreement on 28 February 1997 (hereafter the Agreement), for
the development, registration, manufacture and sale of a controlled-release
pharmaceutical containing nifedipine and Formulated TIMERx (hereinafter the
Designated Product);
WHEREAS, Sanofi wishes to register and sell the Designated Product in South
Korea, in addition to the countries already listed in the Agreement;
WHEREAS, TIMERx Technologies is willing to extend the Territory defined in the
Agreement to South Korea.
NOW THEREFORE THE PARTIES HERETO AGREE AS FOLLOWS:
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ASTERISKS DENOTE SUCH OMISSIONS
ARTICLE 1
The definition of Territory at Article 1.27 of the Agreement is amended by the
addition of South Korea.
ARTICLE 2
Exhibit 1.31 of the Agreement is amended by the addition of the following:
**************************************
**************************************
*************
ARTICLE 3
In consideration for the addition of South Korea to the Territory, Sanofi agrees
to pay TIMERx Technologies a milestone fee of ********************************,
payable within thirty (30) days of the signature of this amendment no. 1 by the
Parties.
ARTICLE 4
All other terms of the Agreement shall remain the same and the Agreement as
amended hereby shall continue in full force and effect between the Parties. The
capitalised terms used herein shall have the same meaning as indicated in the
Agreement.
IN WITNESS WHEREOF the presents have been executed in two original counterparts
on September 1997.
TIMERx Technologies SANOFI WINTHROP INTERNATIONAL
/s/ John V. Talley, Jr. /s/ Jean-Claude Barassat
By: John V. TALLEY, Jr. By: Jean-Claude BARASSAT
Title: President Title: Chief Executive Officer