EXHIBIT 10.95
CONFIDENTIAL TREATMENT REQUESTED
DEVELOPMENT & SUB-LICENSE AGREEMENT
NAPROXEN
This DEVELOPMENT AND SUB-LICENSE AGREEMENT (this "AGREEMENT"), effective from
the date last written hereunder, is entered into between GENTA JAGO TECHNOLOGIES
B.V., a Dutch company, having a place of business at Xxxxxxxxxxxx 00, 0000
Xxxxxxxx, Xxxxxxxxxxx (hereinafter referred to as "GENTA JAGO"), and KRYPTON
LTD., a Gibraltar limited company, having a place of business at East Wing,
Second Level, Xxxxxxxx Xxxxx, Xxxxxxx Xxxxxx, Xxxxxxxxx (hereinafter referred to
as "KRYPTON")
WITNESSETH:
WHEREAS, GENTA JAGO has expertise in the development of controlled-release
formulations for pharmaceutical agents and in particular has exclusive rights to
proprietary know-how and technology generally known and commercialized under the
registered trademark GEOMATRIX(R) and as described and embodied in the Patents
(as defined below) with respect to a Bioequivalent Product (as defined below) to
* and
WHEREAS, KRYPTON is a company which markets pharmaceutical products and is
interested in developing Prototype Formulations (as defined below) for the Final
Product (as defined below) and in seeking the approval of Regulatory Authorities
(as defined below) to manufacture, or have manufactured and market the Final
Product in the Territory (as defined below); and
WHEREAS, GENTA JAGO is prepared to conduct or have conducted certain studies and
the development of the Prototype Formulations and Final Product; and
WHEREAS, GENTA JAGO is prepared to grant to KRYPTON under the terms and
conditions set forth hereafter a sub-license under the Patents, GEOMATRIX(R)
Technology and Know-How (as defined below) to conduct studies relating to the
Prototype Formulations and, upon receipt of approval by the Regulatory Authority
(as defined below), to manufacture or have manufactured, market and sell the
Final Product in the Territory.
NOW, THEREFORE, for and in consideration of the premises, mutual covenants and
agreements contained herein and intending to be legally bound hereby, the
Parties hereby agree as follows:
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 shall have
the following meanings:
1.1 "Active Ingredient" shall mean Naproxen.
1.2 "Affiliate" shall mean, with respect to either Party hereto, any
corporation, partnership or other entity controlled by, controlling or
under common control with, such Party, with "control" meaning direct or
indirect beneficial ownership of more than 50% of the voting power of, or
more than 50% of ownership interest in, such corporation, partnership or
other entity.
1.3 "ANDA" shall mean any Abbreviated New Drug Application filed with the FDA,
by or for KRYPTON requesting authorization to manufacture, have
manufactured or sell the Final Product in the United States of America, or
any equivalent application to a Regulatory Authority in any other country
of the Territory.
1.4 "Bioequivalent Product" shall mean a drug product meeting the
bioequivalence requirements imposed by the FDA for in vitro and/or in vivo
testing as set forth in the regulations of the FDA at 21 C.F.R. ss.320
("AB Equivalent Rating"), as they may be amended from time to time.
1.5 "Competitive Product" shall mean any product other than the Final Product
or the Originator which is a Bioequivalent Product of the Originator and
is marketed and sold in the Territory on a country-to-country basis.
1.6 "FDA" shall mean the U.S. Federal Food and Drug Administration and any
successor agency thereof.
1.7 "Final Product" shall mean the pharmaceutical orally-administered
controlled-release formulation(s) containing the Active Ingredient,
presented as a compressed tablet developed pursuant to this Agreement,
based on the GEOMATRIX(R) Technology and being a Bioequivalent Product of
the Originator, of a Competitive Product or of any other product
containing the Active Ingredient.
1.8 "GEOMATRIX(R) Technology" shall mean the oral controlled-release drug
delivery and related technology licensed to GENTA JAGO by the Licensor
which utilizes a hydrophilic drug-containing matrix tablet which controls
the release of the drug through the use of one or more barrier layers.
1.9 "Gross Margin" shall mean, with respect to any Final Product, Net Sales
less only the direct cost of such Final Product sold, i.e. (a) raw
material cost, (b) direct labor cost, (c) reasonably directly allocable
overhead cost (e.g. energy cost), (d) packaging and labeling
- 2 -
cost, and (e) other costs directly associated with the manufacturing of
such Final Product (e.g. quality control). No other deductions from Net
Sales are permissible for the calculation of Gross Margin, including
without limitation, sales, marketing and distribution costs.
Alternatively, in the event that KRYPTON sub-contracts the manufacturing
of any Final Product to a third party, then "Gross Margin" with respect
to such Final Product shall mean Net Sales less only the manufacturing
costs as invoiced by such manufacturing third party sub-contractor and
actually paid by KRYPTON.
1.10 "Know-How" shall mean all information and data, which are not generally
known including, but not limited to, patent claims and related information
not yet disclosed to the public, formulae, procedures, protocols,
techniques and results of experimentation and testing, which (a) relate to
the GEOMATRIX(R)Technology, any Prototype Formulation or any Final
Product, or (b) are necessary or useful to develop, make or use any
Prototype Formulation, or (c) are necessary or useful to develop, seek
regulatory approval, make, use or sell any Final Product, all to the
extent presently or during the term of this Agreement licensed or
otherwise available to and at the free disposition of GENTA JAGO.
1.11 "License Agreements" shall mean the license agreements entered into by
and between GENTA JAGO and the Licensor, under which the Licensor granted
GENTA JAGO the rights in the Patents, the Know-How and the GEOMATRIX(R)
Technology, which are the subject matter of the sub-license referred to in
Article 11. below.
1.12 "Licensor" shall mean Jagotec AG, a Swiss corporation, having its place of
business at Xxxxxxxxxx 00, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx.
1.13 "Net Sales" shall mean, with respect to any Final Product, the invoiced
sales price of such Final Product in finished package form invoiced by
KRYPTON and/or its Affiliates to any independent customer other than
KRYPTON's Affiliates, less (a) credits, allowances, discounts and rebates
to, and charge-backs from the account of, such independent customers for
spoiled, damaged, out-dated, rejected or returned Final Product; (b)
actual freight and insurance costs incurred and paid by KRYPTON and/or its
Affiliates in transporting such Final Product in final form to such
customers; (c) customary cash, quantity and trade discounts and other
price reduction programs; (d) sales, use, value- added and other direct
taxes (but excluding any income tax) actually incurred and paid by KRYPTON
and/or its Affiliates; and (e) customs duties, surcharges and other
governmental charges incurred by KRYPTON and/or its Affiliates in
connection with the exportation or importation of such Final Product in
final form.
1.14 "Originator" shall mean * actually marketed in the United States by * or
any other pharmaceutical products containing the Active Ingredient and
being marketed in the Territory.
1.15 "Patents" shall mean all patents and patent applications heretofore or
hereafter filed or having presently or in the future legal force in any
country of the Territory, licensed by the Licensor to GENTA JAGO which
claim the GEOMATRIX(R) Technology or the
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 3 -
process to manufacture Prototype Formulations and/or Final Product by use
of, or the use of, the GEOMATRIX(R) Technology, including but not limited
to the patents and patent applications listed in APPENDIX A hereto,
together with all patents that in the future issue therefrom in any
country of the Territory, including utility, model and design patents and
certificates of invention, and all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions, substitutions,
confirmations or additions to any such patents and patent applications,
all to the extent presently or during the term of this Agreement licensed
or otherwise available to and at the free disposition of GENTA JAGO.
1.16 "Prototype Formulations" shall mean the oral delivery system for the
Active Ingredient based on the GEOMATRIX(R) Technology that reasonably
meet the Specifications.
1.17 "Regulatory Authority" shall mean the FDA or any equivalent competent
regulatory authority in any other countries of the Territory.
1.18 "Specifications" shall mean the Products specifications to be mutually
agreed upon.
1.19 "Territory" shall mean *.
ARTICLE 2
DEVELOPMENT PREAMBLE
2.1 At the date of execution of this Agreement, GENTA JAGO has performed
certain preliminary development efforts for the Prototype Formulation.
This development is hereby incorporated in this Agreement.
2.2 GENTA JAGO undertakes to conduct the development of the Prototype
Formulation(s) and the Final Product in an efficient and professional
manner. KRYPTON shall actively support GENTA JAGO regarding the
development and studies to be executed by GENTA JAGO as may be reasonably
required by GENTA JAGO from time to time. In particular, KRYPTON shall
provide information reasonably requested by GENTA JAGO relating to the
Originator and to the Active Ingredient for the purposes of carrying out
this development, including, but not limited to, physico-chemical
characteristics, safe-handling instructions, in-vitro analytical methods,
degradation products and standards and analytical methods therefore.
Additionally, KRYPTON shall provide to GENTA JAGO requested data and
adequate quantities of samples of the Originator for the purposes of
conducting the Feasibility Study. KRYPTON, however, shall not be required
to provide information regarding the Originator which is not in the public
domain, unless KRYPTON is duly authorized to possess and disclose such
non-public information. Any costs and expenses incurred by KRYPTON in
connection with such support shall be borne by KRYPTON.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 4 -
2.3 Due to the nature and complexity of the development and the respective
studies as set forth in this Agreement, the Parties recognize and
acknowledge that problems and delays may occur which render the time
limits set forth in this Agreement and/or the time-frame of the
development as mutually agreed upon difficult or impossible to accomplish.
The Parties agree that they shall immediately inform each other in writing
in the event that significant problems or delays are encountered or
envisaged during the course of the development and shall discuss such
problems and delays in order to agree on a mutually acceptable revision of
the time limits set in this Agreement and/or the time-frame as previously
mutually agreed upon.
2.4 Together with the notice from KRYPTON referred to in Section 3.1 below,
KRYPTON, or its designated supplier, shall supply GENTA JAGO on a
free-of-charge basis with sufficient quantities of Active Ingredient to
perform the development program intended hereunder. Such supplies shall be
accompanied with respective certificates of analysis and conformity. GENTA
JAGO shall use all Active Ingredient supplied to it by KRYPTON hereunder
solely and exclusively in connection with the development program as
mutually agreed upon.
Alternatively, KRYPTON may request that GENTA JAGO obtain a supply of
Active Ingredient from a reputable source having the necessary regulatory
clearances in place to allow future marketing of the Final Product in the
Territory. Should KRYPTON so require and GENTA JAGO so agree, the chosen
supplier's facilities, processes and procedures shall be audited by GENTA
JAGO, or a third party mutually acceptable to KRYPTON and GENTA JAGO, in
order to ensure compliance with the appropriate regulatory requirements.
KRYPTON shall * of GENTA JAGO incurred in carrying out, or having carried
out such audit. GENTA JAGO shall provide KRYPTON with a copy of the audit
report within thirty (30) days as of the completion of the audit.
2.5 In the event that the Parties mutually agree that GENTA JAGO becomes
responsible for the supply of Active Ingredient, KRYPTON shall * GENTA
JAGO for any and all shipping and transportation costs, import duties,
taxes or other costs incurred by GENTA JAGO in connection with such supply
of Active Ingredient upon receipt of GENTA JAGO's respective invoices.
ARTICLE 3
FEASIBILITY STUDY
3.1 KRYPTON shall initiate the development program contemplated hereunder as
soon as technically feasible and within the time limits set forth in the
mutually accepted development program by giving written notice to that
effect to GENTA JAGO. Not later than two (2) months after receipt of (i)
such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall
commence the feasibility study under
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 5 -
this Article 3. and shall use its commercially reasonable efforts to
develop the Prototype Formulations. Up to three (3) of the developed
Prototype Formulations shall be chosen by mutual agreement by the Parties
for further study and development.
The Parties recognize that the Specifications mutually agreed upon
eventually will need to be updated with more detailed specifications for
the Final Product in the course of the development, and in such case the
Parties agree to mutually agree on any reasonable amendment of the
Specifications.
3.2 The development of the Prototype Formulations shall include, but not
necessarily be limited to, the following elements:
(a) Development and establishment of analytical methodology specific to
the characterization of such Prototype Formulations;
(b) Qualitative and quantitative characterization of such Prototype
Formulation;
(c) In-vitro release profile characterization of such Prototype
Formulations and the Originator by using appropriate methodology
mutually agreed to by the Parties;
(d) Elaboration of pre-scale up procedures and the production of samples
(2000 units +/- 10%) of the chosen Prototype Formulations for
evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic
Study under Article 4. below; and
(e) Accelerated stability testing of Prototype Formulations to provide
*.
3.3 GENTA JAGO will ensure the use of generally accepted standards of Good
Laboratory and Manufacturing Practices during the performance of the
feasibility study.
3.4 Within thirty (30) days of the completion of the feasibility study, GENTA
JAGO shall supply KRYPTON with a report (the "Feasibility Study Report")
reasonably detailing the development of the Prototype Formulation(s) and
containing one (1) month accelerated stability data only. A supplement to
the Feasibility Study Report containing the * accelerated stability data
will be forwarded sixty (60) days later.
3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit
to KRYPTON * for the entire Feasibility Study which * shall be reasonably
acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably
incurred by GENTA JAGO during the Feasibility Study, including but not
limited to costs, expenses and fees paid to Jago Pharma and third party
contractors, by the payment of non-refundable development fees. Such
development costs shall be refunded by KRYPTON to GENTA JAGO * upon
receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 6 -
3.6 In the event that the results of the feasibility study conclusively
demonstrate that no Prototype Formulation has been developed which
reasonably meets the Specifications to the good faith mutual satisfaction
of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith
negotiations in order to determine an appropriate course of action,
including, but not limited to, that the Parties may mutually agree to
abandon the development program under this Agreement, and terminate this
Agreement with immediate effect.
ARTICLE 4
PILOT PHARMACOKINETIC STUDY
4.1 Included as part of the feasibility study described in Article 3. above,
KRYPTON shall, at its own responsibility and its own cost, sub-contract
under confidentiality commitments comparable in all material respects to
the provisions set forth herein between GENTA JAGO and KRYPTON to an
external qualified clinical research organization (hereinafter "CRO") to
perform a pilot pharmacokinetic study pursuant to this Article 4.
4.2 The Pilot Pharmacokinetic Study shall consist of commercially reasonable
and appropriately designed * of the Prototype Formulations and the
Originator. KRYPTON shall reasonably consult with GENTA JAGO in the design
of the Pilot Pharmacokinetic Study and shall review the final protocol
with GENTA JAGO prior to initiating work with the selected sub-contractor.
The Pilot Pharmacokinetic Study shall be conducted in accordance with
generally accepted standards of Good Clinical Practice and in compliance
with Ethical Committee requirements or equivalent requirements, where
applicable.
4.3 Prior to the commencement of the Pilot Pharmacokinetic Study GENTA JAGO
shall submit to KRYPTON * for the entire Pilot Pharmacokinetic Study which
* shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA
JAGO's *, reasonably incurred by GENTA JAGO during the Pilot
Pharmacokinetic Study, including but not limited to costs, expenses and
fees paid to Jago Pharma and third party contractors, by the payment of
non-refundable development fees. Such development costs shall be refunded
by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from
GENTA JAGO or Jago Pharma AG.
4.4 KRYPTON shall provide GENTA JAGO with a copy of the report (hereinafter
referred to as the "Pilot Pharmacokinetic Study Report") reasonably
detailing the results of the Pilot Pharmacokinetic Study within six (6)
weeks as of the study's completion and presentation of the preliminary
data for GENTA JAGO's file.
4.5 GENTA JAGO shall have no liability or responsibility whatsoever with
respect to such Pilot Pharmacokinetic Study, including without limitation
the availability or quality of the
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 7 -
results and data from such Pilot Pharmacokinetic Study to be carried out
by KRYPTON and the CRO.
4.6 In the event that the results of the Pilot Pharmacokinetic Study
conclusively demonstrate that it is not fully demonstrated to the good
faith mutual satisfaction of KRYPTON and GENTA JAGO that at least one of
the Prototype Formulations reasonably meet the respective Specifications,
the Parties may mutually agree to abandon the development program and
terminate this Agreement with respect to such Prototype Formulation.
ARTICLE 5
PRE-SCALE-UP ACTIVITIES
5.1 Upon completion of the Pilot Pharmacokinetic Study, KRYPTON may, at its
option, request and charge GENTA JAGO to carry out the pre-scale-up
activities as described in this Article 5. (hereinafter referred to as the
"Pre-Scale-Up Activities"). KRYPTON shall, within thirty (30) days as from
the date of the Pilot Pharmacokinetic Study Report notify in writing GENTA
JAGO of its decision whether to proceed with and to have GENTA JAGO
perform the Pre-Scale-Up Activities.
5.2 Prior to the commencement of the Pre-Scale-Up Activities GENTA JAGO shall
submit to KRYPTON * for the entire Pre-Scale-Up Activities which * shall
be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's
*, reasonably incurred by GENTA JAGO during the Pre-Scale Up activity,
including but not limited to costs, expenses and fees paid to Jago Pharma
and third party contractors, by the payment of non-refundable development
fees. Such pre scale up costs shall be refunded by KRYPTON to GENTA JAGO *
upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG.
5.3 The Pre-Scale-Up Activities to be performed by GENTA JAGO shall comprise
all reasonable activities necessary to allow the technology transfer to,
and subsequent scale-up at, the mutually established manufacturing site,
including, but not limited to, final optimization of the Prototype
Formulation (where necessary), development and validation of the scale-up
manufacturing procedure and analytical validation. Such Pre-Scale-Up
Activities shall be completed within the time period mutually agreed upon
by the Parties in Appendix D hereto, calculated as from the date of
receipt of the KRYPTON's notice by GENTA JAGO pursuant to Section 5.1
above.
5.4 In the event that additional clinical testing, including without
limitation, confirming pharmacokinetic studies, is reasonably required or
deemed necessary beyond the program envisaged in this Agreement in order
to satisfy the FDA requirements for an NDA or ANDA approval of the
Product, KRYPTON and GENTA JAGO shall meet to discuss in good faith the
appropriate course of action to be followed and agree upon any such
additional testing to be performed, provided that any such additional
testing shall in any
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 8 -
event be funded solely by KRYPTON.
5.5 Not later than upon the initiation of the Pre-Scale-Up Activities, the
Parties shall establish and mutually agree upon a manufacturing site,
where the Bio-Batches referred to in Section 7.2 below required for the
pivotal clinical studies will be produced and where the Final Product
shall be manufactured for commercial use after FDA approval(s) for the
Final Product have been granted.
ARTICLE 6
PRE-PIVOTAL PHARMACOKINETIC STUDY
6.1 Included as part of the Pre-Scale-Up Activities, KRYPTON shall at its own
responsibility and its own cost, perform or have performed with a CRO
selected by KRYPTON, a pre- pivotal pharmacokinetic study pursuant to this
Article 6. (hereinafter referred to as "Pre- Pivotal Study"). Such
Pre-Pivotal Study shall consist of *, to select the best of the Prototype
Formulations for each dose strength to be used in the further development
under this Agreement.
6.2 The Pre-Pivotal Study shall be performed in the United States of America.
KRYPTON shall consult, review and mutually agree with GENTA JAGO on the
design and final protocol of such Pre-Pivotal Study prior to initiating
work with the selected CRO.
6.3 KRYPTON shall reimburse to GENTA JAGO * incurred by GENTA JAGO to cover
its workload for preparation and consulting of such Pre-Pivotal Study.
Such development costs shall be paid by KRYPTON * upon receipt by KRYPTON
of an invoice from GENTA JAGO or Jago Pharma AG.
6.4 KRYPTON shall provide GENTA JAGO with a copy of the report detailing the
results of the Pre-Pivotal Study within ten (10) days of its completion
for GENTA JAGO's file. GENTA JAGO shall have no liability or
responsibility whatsoever with respect to such Pre-Pivotal Study,
including without limitation, the performance or conduct of such Pre-
Pivotal Study or the availability or quality of the results and data from
such Pre-Pivotal Study to be carried out by KRYPTON and the CRO.
6.5 Upon completion of the Pre-Pivotal Study and availability of the results
of such Pre- Pivotal Study, the Parties shall consult with each other on
such results and mutually agree in writing upon the Prototype Formulation
to be selected for further development under this Agreement. In the event
that the results of the Pre-Pivotal Study are unsatisfactory in that it is
not fully demonstrated to the good faith mutual satisfaction of the
Parties that at least one of the Prototype Formulations meet the
respective Specifications, KRYPTON may elect to abandon the development
program and terminate this Agreement with respect to such Prototype
Formulation by giving written notice to that effect to GENTA JAGO.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 9 -
ARTICLE 7
FURTHER ACTIVITIES
7.1 Technology Transfer
Upon mutual agreement of the Prototype Formulation to be used for
development as referred to in Section 6.5 above, GENTA JAGO shall be
responsible for and initiate the technology transfer to, and perform the
scale-up at, the manufacturing site mutually established and agreed upon
by the Parties. GENTA JAGO agrees that such technology transfer, and in
particular the aspects of scale-up and validation of the manufacturing
process shall be carried out by GENTA JAGO on such equipment as shall
eventually be used by KRYPTON or a third party to manufacture the Final
Product. Upon completion of such scale-up, GENTA JAGO shall notify KRYPTON
thereof in writing.
7.2 Production of Industrial Scale Batches
Upon receipt by KRYPTON of GENTA JAGO's notice referred to in Section 7.1
above, the Parties shall initiate the production of three (3) industrial
scale batches (hereinafter "Bio-Batches") on such equipment as shall
eventually be used KRYPTON or a third party to commercially manufacture
the Final Product, based on the Prototype Formulation (the size of each
Bio-Batch to be not less than the greater of (i) 10% (ten percent) of the
anticipated initial commercial batch size, or (ii) 100,000 tablets),
according to Current Good Manufacturing Practices, such Bio-Batches to be
subsequently used for stability testing and pivotal clinical studies;
provided however, that GENTA JAGO shall have the ultimate responsibility
with respect of any and all technical aspects of such production of
batches related to the technology transfer and the implementation of such
technology in the manufacturing site.
7.3 Funding of Further Activities
(a) Prior to the commencement of any activities under Sections 7.1 and
7.2 above GENTA JAGO shall submit to KRYPTON * for such further
activities which * shall be reasonably acceptable to KRYPTON.
KRYPTON shall refund GENTA JAGO's * reasonably incurred by GENTA
JAGO under Sections 7.1 and 7.2 above, including but not limited to
costs, expenses and fees paid to Jago Pharma and third party
contractors, by the payment of non-refundable development fees. Such
further development costs shall be refunded by KRYPTON * upon
receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG.
(b) Furthermore, KRYPTON shall be responsible, at its own cost, for the
supply of all raw material including, but not limited to, the Active
Ingredients required or necessary for, and all additional costs and
expenses whatsoever arising out of or in connection with, the
production of the Bio-Batches described in Section 7.2
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 10 -
above and all other costs associated with the use of facilities,
technology transfer, equipment and analytical services.
7.4 Stability Testing
(a) KRYPTON shall be responsible for and perform or have performed at
its own cost, the stability testing of the Final Product according
to the then current requirements of the FDA in bulk packaging and in
the final packaging materials. GENTA JAGO shall have no liability or
responsibility whatsoever with respect to such stability testing,
including without limitation, the performance or conduct of such
stability testing or the availability or quality of the results and
data from such stability testing to be carried out or requested by
KRYPTON.
(b) KRYPTON shall provide to GENTA JAGO with a copy of all stability
testing data within thirty (30) days after the completion of each
stability testing period (hereinafter referred to as the "Final
Stability Testing Report") for GENTA JAGO's file.
(c) GENTA JAGO agrees to provide additional technical assistance and
consultation as may be reasonably requested by KRYPTON in connection
with the stability testing of the Final Product. KRYPTON shall pay
to GENTA JAGO for such services provided by GENTA JAGO's or Jago
Pharma's personnel an amount of USD * or part thereof spent, and
furthermore, KRYPTON shall reimburse GENTA JAGO for all reasonable
and documented travel related expenses of GENTA JAGO personnel who
travel at KRYPTON's request to locations remote from such
personnel's usual working location.
7.5 Further Provisions
In the event that KRYPTON and GENTA JAGO shall reasonably deem the results
or data from any of the activities to be performed by either Party under
this Article 7. with respect to any dose strength be unsatisfactory for
any reason, the Parties may mutually agree to abandon the development
program and terminate this Agreement with immediate effect.
ARTICLE 8
PIVOTAL CLINICAL STUDY
8.1 Promptly upon completion of the further activities referred to in Article
7. above, KRYPTON shall, at its own responsibility and its own cost,
sub-contract under confidentiality commitments comparable to the
provisions set forth herein between GENTA JAGO and KRYPTON to an external
qualified CRO of its choice, reasonably acceptable to GENTA JAGO, to
perform and manage a series of pivotal clinical studies
(hereinafter"Clinical Studies") in man required and/or necessary for any
subsequent NDA or ANDA for the Final Product in accordance with the then
current requirements of the FDA.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 11 -
8.2 KRYPTON shall consult, review and agree with GENTA JAGO on the design and
the final protocol of such Clinical Studies prior to initiating work with
the selected subcontractor.
8.3 KRYPTON shall reimburse to GENTA JAGO the * incurred by GENTA JAGO to
cover its workload for preparation and consulting of such Clinical
Studies. Such development costs shall be paid by KRYPTON * upon receipt by
KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG.
8.4 KRYPTON shall provide GENTA JAGO with a copy of the report detailing the
results of the Clinical Studies within ten (10) days of its completion for
GENTA JAGO's file.
8.5 GENTA JAGO shall have no liability or responsibility whatsoever with
respect to such Clinical Studies, including without limitation, the
performance or conduct of such Clinical Studies or the availability or
quality of the results and data from such Clinical Studies to be carried
out or requested by KRYPTON.
8.6 In the event that the results of the Pivotal Clinical Studies are
unsatisfactory in that it is not fully demonstrated to the good faith
mutual satisfaction of KRYPTON and GENTA JAGO that the Prototype
Formulation reasonably meets the respective Specifications, the Parties
may mutually agree to abandon the development program and terminate this
Agreement with respect to such dose strength.
ARTICLE 9
THE REGULATORY (NDA OR ANDA) SUBMISSION
9.1 Upon completion of the Clinical Studies, KRYPTON may, at its option, elect
to prepare and submit to the FDA an NDA or ANDA. KRYPTON shall notify
GENTA JAGO of its election to exercise or not to exercise this option by
giving written notice thereof to GENTA JAGO within thirty (30) days as of
the availability of the results of the Clinical Studies.
9.2 In the event that KRYPTON elects pursuant to Section 9.1 above to make NDA
or ANDA submission(s) to any Regulatory Authority with respect to a Final
Product, KRYPTON shall have sole liability and responsibility for the
prosecution, conduct and results of such NDA or ANDA and shall bear all
costs in connection therewith. KRYPTON, at KRYPTON's option, may elect by
written notice to GENTA JAGO prior to commencement of the technology
transfer referred to in Section 7.1 above to have the NDA or ANDA dossier
prepared on its behalf by a qualified third party acceptable to GENTA
JAGO. KRYPTON shall be liable and responsible for any and all costs
associated with such sub-contracting.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 12 -
9.3 KRYPTON or its chosen sub-contractor shall consult with GENTA JAGO, and
GENTA JAGO agrees to provide additional technical assistance and
consultation as may be reasonably requested by KRYPTON or the chosen
sub-contractor, in connection with the preparation and prosecution of any
NDA or ANDA or with the preparation of the dossier to be submitted to the
FDA. KRYPTON shall pay to GENTA JAGO for such services and consultation
provided by GENTA JAGO's personnel an amount of USD * or any part thereof
spent. Furthermore, KRYPTON shall reimburse GENTA JAGO for reasonable and
documented travel-related expenses of GENTA JAGO personnel who travel at
KRYPTON's request to the elected manufacturing facility(ies) or other
locations remote from such personnel's usual working location.
ARTICLE 10
PROPRIETARY RIGHTS AND PATENTS
10.1 Patents and Proprietary Rights of GENTA JAGO
(a) The Licensor and GENTA JAGO, respectively, shall retain title to and
ownership of Patents, Know-How and GEOMATRIX(R) Technology licensed
to GENTA JAGO, including, but not limited to, any and all
developments and inventions relating to Patents, Know-How and
GEOMATRIX(R) Technology (hereinafter collectively referred to as
"GENTA JAGO IPR").
(b) KRYPTON shall not, directly or indirectly through its officers,
directors, employees, agents, customers or other controlled or
associated third parties, acquire any proprietary interest in or
other right to GENTA JAGO IPR, other than provided in this
Agreement.
(c) GENTA JAGO shall use all commercially reasonable efforts, at its own
cost, to cause the Licensor to prepare, prosecute and maintain all
patent applications and patents constituting Patents, and shall keep
KRYPTON fully and promptly informed on any developments or changes
relating thereto. If the Licensor decides not to further prosecute
any patent application constituting Patents, GENTA JAGO shall
promptly inform KRYPTON of such decision in writing, and the Parties
shall, upon KRYPTON's reasonable written request, meet with the
Licensor to discuss any reasonable appropriate action. During the
term of this Agreement, GENTA JAGO shall, at its sole cost, use all
commercially reasonable efforts to cause the Licensor to take all
steps necessary to maintain Patents to the extent GENTA JAGO deems
commercially reasonable. If the Licensor decides not to maintain any
patent constituting Patents, GENTA JAGO shall promptly inform
KRYPTON of such decision in writing, and the Parties shall, upon
KRYPTON's reasonable written request, meet with the Licensor to
discuss any reasonable appropriate action. Notwithstanding the
foregoing, KRYPTON acknowledges to GENTA JAGO that Licensor has the
final authority regarding such preparation, prosecution and
maintenance of all patent applications and patents.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 13 -
10.2 Patents and Proprietary Rights for Final Products
(a) KRYPTON shall retain title to and ownership of all developments,
whether patentable or not, relating specifically and exclusively to
the Final Products, provided that such developments are entirely
independent of any and all GENTA JAGO IPR (hereinafter collectively
referred to "Final Product IPR").
(b) KRYPTON shall be responsible for and shall control, at its own cost,
the preparation, prosecution and maintenance of all Final Product
IPR and shall keep GENTA JAGO fully and promptly informed on any
developments or changes relating thereto. During the term of this
Agreement, KRYPTON shall, at its sole cost, take all steps necessary
to prosecute and/or maintain all Final Product IPR to the extent
KRYPTON deems commercially reasonable. If KRYPTON intends not to
further prosecute and/or maintain any of the Final Product IPR,
KRYPTON shall promptly inform GENTA JAGO of such intention in
writing, and GENTA JAGO shall have the right and option, but not the
obligation, to have transferred to it sole title to and ownership in
such Final Product IPR free of any charge by giving respective
written notice thereof to KRYPTON within thirty (30) days after
GENTA JAGO's receipt of KRYPTON's notice referred to above.
(c) In the event GENTA JAGO has and exercises its right and option
referred to Section 10.2 (b) above to have transferred to it any
such Final Product IPR, KRYPTON shall promptly undertake any and all
steps required and/or necessary to transfer title to and ownership
of such Final Product IPR to GENTA JAGO. In the event that GENTA
JAGO exercises its option to have transferred such Final Product IPR
from KRYPTON to GENTA JAGO, GENTA JAGO shall maintain such Final
Product IPR during the term of this Agreement to the extent GENTA
JAGO deems commercially reasonable and shall bear all cost
associated therewith incurred after the date of GENTA JAGO's notice
to KRYPTON exercising its option referred to in Section 10.2 (b)
above. In such case, the Parties shall negotiate in good faith the
terms and condition, under which such Final Product IPR transferred
to GENTA JAGO shall be included in the License pursuant to Article
11. below.
10.3 Notification of Infringement
(a) If KRYPTON becomes aware of (i) any product or activity of any kind
that involves or may involve an infringement or violation of GENTA
JAGO IPR or Final Product IPR or (ii) any third-party action, claim
or dispute (including, but not limited to, actions for declaratory
judgment alleging the invalidity or non- infringement) based upon or
arising out of GENTA JAGO IPR or Final Product IPR, then KRYPTON
shall promptly notify GENTA JAGO in writing of any such
infringement, violation, action, claim or dispute.
(b) If GENTA JAGO becomes aware of (i) any product or activity of any
kind that
- 14 -
involves or may involve an infringement or violation of GENTA JAGO
IPR with respect to Final Products or of Final Product IPR; or (ii)
any third-party action, claim or dispute (including, but not limited
to, actions for declaratory judgment alleging the invalidity or
non-infringement) based upon or arising out of GENTA JAGO IPR with
respect to Final Products or of Final Product IPR, then GENTA JAGO
shall promptly notify KRYPTON in writing of any such infringement,
violation, action, claim or dispute.
10.4 Enforcement of GENTA JAGO IPR
(a) GENTA JAGO, at its sole expense, shall have the right, but not the
obligation, (i) to determine the appropriate course of action to
enforce, or otherwise xxxxx the infringement of, or defend
third-party actions regarding, GENTA JAGO IPR, (ii) to take, or
refrain from taking, appropriate action to enforce, or defend
third-party actions regarding, GENTA JAGO IPR, (iii) to control any
litigation or other enforcement action regarding GENTA JAGO IPR, and
(iv) to enter into, or permit, the settlement of any such litigation
or other enforcement action regarding GENTA JAGO IPR. GENTA JAGO
shall keep KRYPTON informed on a regular basis on its taking or
refraining from taking, and the development of, any of the foregoing
actions, and shall consider, in good faith, the interests of KRYPTON
under this Agreement when taking any of the foregoing actions, to
the extent that any such action or such infringement may have an
adverse effect on Final Product. KRYPTON shall, at its own cost,
fully cooperate with GENTA JAGO in the planing and execution of any
suit or other action to enforce, or defend third-party actions
regarding, GENTA JAGO IPR as reasonably required or requested by
GENTA JAGO.
(b) If GENTA JAGO does not within one-hundred-twenty (120) days, or any
shorter delay imposed by any applicable law or regulation or court
or authority having jurisdiction, after receiving notice of any
infringement or violation of GENTA JAGO IPR which may adversely
affect Final Products, or of any third-party action, claim or
dispute based upon or arising out of GENTA JAGO IPR which may
adversely affect Final Products, commence or take an action to
enforce, or otherwise xxxxx such infringement, or defend against
such third-party action, then the Parties shall, upon KRYPTON's
written request, promptly meet to discuss any reasonable appropriate
action with regard to such enforcement of GENTA JAGO IPR which may
adversely affect Final Products, provided however, that KRYPTON is
aware and acknowledges that in such case the Licensor will have the
right to enforce any and all GENTA JAGO IPR pursuant to the License
Agreements.
(c) Subject to the right of the Licensor to control any suit or other
action with regard to GENTA JAGO IPR as outlined in the preceding
section, KRYPTON, upon its written request and at its sole expense,
shall be made an additional, but not controlling party, in any such
suit or other action where necessary to obtain complete relief
regarding the subject infringement or violation.
- 15 -
10.5 Enforcement of Final Product IPR
(a) KRYPTON, at its sole expense, shall have the right, but not the
obligation, (i) to determine the appropriate course of action to
enforce, or otherwise xxxxx the infringement of, or defend
third-party actions regarding, Final Product IPR, (ii) to take, or
refrain from taking, appropriate action to enforce, or defend
third-party actions regarding, Final Product IPR, (iii) to control
any litigation or other enforcement action regarding Final Product
IPR, and (iv) to enter into, or permit, the settlement of any such
litigation or other enforcement action regarding Final Product IPR.
Notwithstanding anything contained in the preceding sentence,
KRYPTON shall not settle any suit or action or otherwise consent to
an adverse judgment in such suit or action without the prior written
consent of GENTA JAGO, which consent shall not be withheld
unreasonably. KRYPTON shall keep GENTA JAGO informed on a regular
basis on its taking or refraining from taking, and the development
of, any of the foregoing actions, and shall consider, in good faith,
the interests of GENTA JAGO under this Agreement and in GENTA JAGO
IPR, when taking any of the foregoing actions.
(b) If KRYPTON does not, within one-hundred-and-twenty (120) days, or
any shorter delay imposed by any applicable law or regulation or
court or authority having jurisdiction, after receiving notice of
any infringement or violation of Final Product IPR, or of any
third-party action, claim or dispute based upon or arising out of
Final Product IPR, commence or take an action to enforce, or
otherwise xxxxx such infringement, or defend against such
third-party action, then GENTA JAGO shall have the right, but not
the obligation, at its sole expense, to take and control such action
as it deems appropriate to enforce, or xxxxx the infringement of, or
defend against such third-party action, regarding Final Product IPR.
GENTA JAGO shall keep KRYPTON informed on a regular basis of any
such action and consider, in good faith, the interests of KRYPTON
under this Agreement when taking any of the foregoing actions.
KRYPTON, upon its written request and at its sole expense, shall be
made an additional, but not controlling party, in any such suit or
other action controlled by GENTA JAGO where necessary to obtain
complete relief regarding the subject infringement or violation.
10.6 Application of Monies Recovered
Subject always to the right of the Licensor to control any suit or
other action with regard to GENTA JAGO IPR as outlined in Section
10.4(c) and any right to receive any monies recovered therefrom as
provided for in the License Agreements, all monies recovered upon
the final judgment or settlement of any suit or other action under
this Sections 10.4 or 10.5 shall be applied as follows:
- 16 -
(i) to cover any and all costs and expenses (including attorney's fees)
incurred by the Party controlling such suit or other action;
(ii) to cover any and all costs and expenses (including attorney's fees)
reasonably, or upon request of the controlling Party, incurred by
the other Party in connection with such suit or other action, if
any;
(iii) the remainder, if any, to the Party controlling any such suit or
other action.
ARTICLE 11
SUB-LICENSE AGREEMENT
11.1 GENTA JAGO hereby grants to KRYPTON the exclusive and sublicenseable right
and sub-license (hereinafter referred to as the "License") to use,
manufacture, have manufactured, sell and market the Final Products in the
Territory and to use the Patents, GEOMATRIX(R) Technology and Know How
exclusively for that purpose subject to the payment of the * and the
Royalties pursuant to Articles 13. and 14. below.
11.2 The rights of KRYPTON to grant any sub-license in any part of the
Territory shall be subject to the requirement that KRYPTON shall obtain
the written approval of GENTA JAGO prior to executing any such sub-license
agreement, which approval shall not unreasonably be withheld, provided
however, that no such approval by GENTA JAGO shall be required for any
sub-license to an Affiliate of KRYPTON .
11.3 In any event KRYPTON shall be responsible for any and all acts, deeds and
undertakings of its permitted sub-licensee(s) and KRYPTON and its
permitted sub-licensee(s) shall continue to be bound by all terms and
provisions under this Agreement throughout its term. In case that KRYPTON
sub-licenses rights and/or the License to any sub-licensee(s) approved by
GENTA JAGO, such sub-licensee(s) shall agree in writing to any and all of
KRYPTON's obligations and undertakings under this Agreement, including but
not limited to its confidentiality obligations set forth hereinafter.
Furthermore, KRYPTON undertakes that any and all sub-license agreements
shall provide for inspection and audit provisions identical to the
provisions set forth below in order to enable GENTA JAGO to control and
audit and receive any and all fees and Royalties due as provided in this
Agreement. KRYPTON shall provide GENTA JAGO promptly with reasonable
appropriate information on its sub-licensee(s) and copies of all
agreements with such sub-licensee(s) (with only the commercial terms may
be redacted).
ARTICLE 12
MANUFACTURING AND PRODUCT LIABILITY
12.1 In the event that KRYPTON, subject to Section 5.5 above, elects GENTA
JAGO, and GENTA JAGO expressly agrees to such manufacture, or any of its
Affiliates shall
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 17 -
manufacture Final Products, then the Parties agree to enter into good
faith negotiations on and to use commercially reasonable efforts to
execute in due time a respective Manufacturing and Supply Agreement,
according to which GENTA JAGO or its Affiliates shall undertake to
manufacture and supply Final Products in sufficient quantities to meet
KRYPTON's requirements, at a sale price for such Final Products
manufactured equal to GENTA JAGO's * In the event and for such period of
time, that GENTA JAGO or its Affiliate manufactures and supplies Final
Product under such Manufacturing and Supply Agreement, the Royalty Rate
referred to in Section 14.1 below shall be *.
12.2 In the event that KRYPTON or any of its Affiliates or any third party is
elected pursuant to Section 5.5 above to manufacture Final Product, then
KRYPTON undertakes and agrees that at all times the Specifications and to
any and all laws, rules and regulations imposed by any competent authority
on the manufacturing, marketing, distribution and sale of Final Products
are strictly adhered to by the manufacturer, and KRYPTON shall during the
entire term of this Agreement be solely and fully liable and responsible
for the compliance with all such laws, rules and regulations when
manufacturing, having manufactured, marketing, distributing and selling
Final Products itself and/or through Affiliates or sub- licensee(s).
12.3 KRYPTON shall indemnify, defend and hold GENTA JAGO, its Affiliates and
the Licensor harmless from and against any losses, claims, liabilities,
costs and expenses (including reasonable attorney's fees) that may be
imposed upon or asserted against GENTA JAGO and/or its Affiliates and/or
the Licensor as a result of the marketing, distributing, manufacture, use
or sale of Final Products by or on behalf of KRYPTON, its Affiliates,
agents or sub-licensee(s), except for those claims, liabilities, costs and
expenses arising from gross negligence or intentional misconduct on the
part of GENTA JAGO, its Affiliates or the Licensor.
ARTICLE 13
* PAYMENTS AND OTHER CONSIDERATION
13.1 As consideration for GENTA JAGO's preliminary development efforts for the
Prototype Formulation performed prior to the execution of this Agreement
as referred to in Section 2.1 above, KRYPTON undertakes to pay to GENTA
JAGO an initial *, payable upon execution of this Agreement.
13.2 As consideration for the License granted by GENTA JAGO to KRYPTON under
this Agreement and in consideration of certain major development steps
achieved hereunder, KRYPTON undertakes to pay to GENTA JAGO a *:
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 18 -
(a) * KRYPTON's receipt of GENTA JAGO's notice referred to in Section
7.1 above; and
(b) *; and
(c) * for the Final Product; and
(d) * for the Final Product.
13.3 Unless otherwise agreed by the Parties in writing, all payments under this
Article 13. shall be made in United States Dollars and to such place or
account as GENTA JAGO reasonably requests from time to time in writing.
ARTICLE 14
ROYALTIES
14.1 During a period commencing upon the first commercial sale of Final Product
in each country of the Territory and ending upon the earlier of (i) the
fifteenth (15th) anniversary of the first commercial sale of Final Product
in such country of the Territory, and (ii) the expiration of the last of
the Patents covering Final Product in such country of the Territory
(hereinafter referred to as the"Royalty Term"), and in further
consideration of the License granted to KRYPTON by GENTA JAGO, KRYPTON
shall pay to GENTA JAGO a royalty (hereinafter referred to as
the"Royalty") of an amount equal to * of the Final Product in the
Territory.
14.2 The Parties agree that * shall be applicable for the first time on sales
of such Final Product in such country of the Territory after the beginning
of the calendar quarter immediately following the first commercial sale of
such Competitive Product.
14.3 Royalties shall be payable on a quarterly basis. KRYPTON shall remit to
GENTA JAGO within six (6) weeks after the end of each calendar quarter the
amount of Royalty due with respect to Net Sales and/or Gross Margin, as
the case may be, achieved in the preceding quarter, beginning with the
calendar quarter in which the first commercial sale of the Final Product
is made in any country of the Territory. KRYPTON shall deliver to GENTA
JAGO, along with such remittance of Royalty payments, a detailed statement
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 19 -
(hereinafter referred to as the "Royalty Report") of the Net Sales and/or
Gross Margin, as the case may be, of the Final Product on a
country-by-country basis to which the Royalty payment relates.
14.4 All Royalty Reports shall be prepared in accordance with generally
accepted accounting principles consistently applied from applicable period
to period and shall be certified by an officer of KRYPTON as being so
prepared, true, accurate and correct.
14.5 Unless otherwise agreed by the Parties in writing, payments of Royalties
shall be made in United States Dollars and to such place or account as
GENTA JAGO reasonably requests from time to time in writing. Any
conversions into United States Dollars from the currency in which the
corresponding Net Sales and/or Gross Margin for such Royalties were made,
are to be calculated as using the average closing buying rate for such
currency quoted in the continental terms method of quoting exchange rates
(local currency per USD 1) published in the Wall Street Journal on the
last business day of the applicable reporting period covered by such
Royalty Report.
ARTICLE 15
INSPECTION AND AUDIT
15.1 During the term of this Agreement and during a period of twelve (12)
months after its expiration or termination for any reason, upon the
written request of GENTA JAGO and not more than once each calendar year,
KRYPTON shall permit an independent certified public accountant of
internationally recognized standing selected by GENTA JAGO, at GENTA
JAGO's expense, to have access during regular business hours to such of
the records of KRYPTON and its Affiliates as may be reasonably necessary
to verify the accuracy of the Royalty Reports for any year ending not more
than thirty-six (36) months prior to the date of such request. The
accounting firm shall disclose to GENTA JAGO only whether the Royalty
Reports and records of KRYPTON and its Affiliates and the amount of
Royalties actually paid are correct or not and the specific details
concerning any discrepancies; no other information shall be shared. The
Parties agree to accept such written audit report as final and binding
upon them.
15.2 If such independent accounting firm correctly concludes that additional
Royalties were owed during any such period audited, KRYPTON shall pay such
additional Royalties within ten (10) days of the date GENTA JAGO delivers
to KRYPTON such accounting firm's written report so concluding. The fees
and expenses charged by such accounting firm with respect to such audit
shall be paid by GENTA JAGO; provided however, if any such audit correctly
discloses that Royalties payable by KRYPTON for the audited period are
more *, then KRYPTON shall pay all reasonable fees and expenses charged by
such accounting firm with respect to such audit.
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 20 -
15.3 GENTA JAGO shall treat all financial information subject to review under
this Article 15. as confidential and subject to the confidentiality
obligations in Article 16. below.
ARTICLE 16
CONFIDENTIALITY
16.1 Confidential Information. KRYPTON shall maintain in confidence all
Know-How and other information of GENTA JAGO (including samples) disclosed
by GENTA JAGO and identified as, or acknowledged to be, confidential
(the"Confidential Information"), and shall not use, disclose or grant the
use of the Confidential Information except on a need- to-know basis to its
directors, officers, employees, agents, consultants, clinical
investigators or other permitted contractors, to the extent such
disclosure is reasonably necessary in connection with KRYPTON's activities
as expressly authorized by this Agreement. To the extent that disclosure
is authorized by this Agreement, prior to disclosure, KRYPTON hereto shall
obtain agreement in writing of any such person to hold in confidence and
not make use of the Confidential Information for any purpose other than
those authorized by this Agreement. KRYPTON shall notify GENTA JAGO
promptly upon the discovery of the unauthorized use or disclosure of the
Confidential Information.
16.2 Permitted Disclosures. The obligations of confidentiality and non-use
contained in Section 16.1 above shall not apply to the extent that (a)
KRYPTON (i) is required to disclose information by law, regulation or
order of a governmental agency or a court of competent jurisdiction, or
(ii) is required to disclose information to any governmental agency for
purposes of obtaining approval to test or market Final Product, provided
in each case that KRYPTON shall give GENTA JAGO written notice thereof and
sufficient opportunity to object to any disclosure or to request
confidential treatment thereof, or (b) KRYPTON can demonstrate that (i)
the disclosed information was public knowledge at the time of such
disclosure to it, or thereafter became public knowledge, other than as a
result of actions of KRYPTON, its directors, officers and employees in
violation hereof; (ii) the disclosed information was rightfully known by
KRYPTON (as shown by its written records) prior to the date of disclosure
to it by GENTA JAGO hereunder; (iii) the disclosed information was
disclosed to KRYPTON on an unrestricted basis from a source unrelated to
any party to this Agreement and not under a duty of confidentiality to
GENTA JAGO or the Licensor; or (iv) the disclosed information was
independently developed by KRYPTON without the use of Confidential
Information disclosed by GENTA JAGO.
16.3 Terms of this Agreement. Except as otherwise provided in Section 16.2
above, neither Party shall disclose any terms or conditions of this
Agreement to any third party (other than the Licensor) without the prior
consent of the other Party. Notwithstanding the foregoing, prior to the
execution of this Agreement, the Parties shall agree upon the substance of
information that can be used to describe the terms of this transaction,
and the Parties may disclose such information only without the other
Party's consent. Notwithstanding the foregoing, prior to the execution of
the Agreement, the Parties shall
- 21 -
agree upon the substance of information that can be used to describe the
terms of this transaction, and the Parties may disclose such information
without the other Party's consent.
16.4 Term of Confidentiality. The confidentiality obligations under this
Article 16 shall be effective during the term of this Agreement and for a
period of ten (10) years after the expiration or earlier termination
hereof.
16.5 Injunctive Remedies. GENTA JAGO shall be entitled to injunctive remedies
and relief against KRYPTON and its Affiliates and any third parties for
any breach or threatened breach of the confidentiality obligations under
this Article 16.
16.6 Damages. In the event of a breach of the confidentiality provisions under
this Article 16 by KRYPTON, its Affiliates or its directors, officers,
employees or any other person who were given access to the Confidential
Information by KRYPTON, GENTA JAGO shall be entitled to receive from
KRYPTON any and all actual costs and damages caused by such breach.
16.7 Public Announcements. Neither Party shall make any press releases or other
public announcements or disclosures regarding the execution and the
existence of this Agreement or any activities conducted hereunder,
including development results, filings and registrations, without the
prior written consent of the other Party, except for such public
disclosure as may be necessary in the opinion of any party's legal advisor
in order not to be in violation of or default under any applicable law,
regulation or governmental order, in such later event the party having an
obligation to disclose shall submit to the other party a draft of the
required announcement and shall give the other party the opportunity to
request reasonable amendments and modifications of such required
announcement..
ARTICLE 17
TERM AND TERMINATION
17.1 Term and Expiration
(a) This Agreement shall expire on a country-by-country basis upon the
expiration of the Royalty Term.
(b) Upon the expiration of this Agreement in each country of the
Territory pursuant to Section 17.1 (a) above and payment of all
fees, including but not limited to the *, and all Royalties and
other payments by KRYPTON due GENTA JAGO under this Agreement, the
License shall be deemed to be a perpetual, fully paid-up and
royalty-free license for such Final Product and each such country of
the Territory.
17.2 Termination Prior to Registration
-------------
* Confidential treatment requested. The redacted material has been separately
filed wit the Commission.
- 22 -
During the development, test, study and registration phases as specified
in Articles 3. through 8. above, and until the first successful
registration approval of any Final Product by any Regulatory Authority,
this Agreement may be terminated in accordance with the provisions set
forth in Sections 3.6, 4.6, 6.5, 7.5 and 8.6 above.
17.3 Termination for Cause
During the entire term of this Agreement either Party may terminate this
Agreement by giving to the other Party written notice to that effect, if
any of the following events occur:
(a) the other Party is in default or in breach of a term or provision
hereof and such default or breach continues and is not remedied
within thirty (30) days upon the other Party's written request to
remedy such default or breach; or
(b) the other Party shall commit a breach of any of the confidentiality
provisions of Article 16. above; or
(c) the other Party goes into liquidation, voluntarily or otherwise,
other than for the sole purpose of reorganization, or goes into
bankruptcy or makes an assignment for the benefit of creditors, or
in the event of a receiver being appointed of the other Party's
property or parts thereof.
17.4 Effect of Termination
(a) If KRYPTON elects to so terminate the Agreement under Section 17.2
above prior to filing of the ANDA in the United States, then: (i)
such termination shall be without penalty or liability to KRYPTON;
(ii) all rights and licenses granted by GENTA JAGO hereunder shall
revert to GENTA JAGO with respect to such country(ies) so
terminated, (iii) KRYPTON be relieved of any payments that are
scheduled or may be made in the future under this Agreement, (iv)
KRYPTON shall return to GENTA JAGO all materials, documentation,
information, data and other things furnished by GENTA JAGO in
connection with this Agreement, including without limitation any and
all Confidential Information, together with all copies thereof in
KRYPTON's possession or under its control, (v) all Registrations
pertaining to the marketing of the Product shall be transferred to
and be owned by GENTA JAGO as to the affected country(ies) and the
data generated under this Agreement shall be provided to and
thereafter may be freely used by GENTA JAGO to develop, manufacture
and market the Product; and (vi) GENTA JAGO and its Affiliates shall
thereafter be entitled to exercise such rights as they may have
under their own license agreements to make, have made, use or sell
the Product in the country(ies) so terminated without compensation
or obligation to KRYPTON; provided, that the foregoing rights under
(iv) and (vi) shall not create or imply any right or license under
any patent rights, copyright rights, trademarks or trade names,
know-how, or other intellectual property rights owned or controlled
by KRYPTON or its Affiliates.
- 23 -
(b) If KRYPTON elects to so terminate this Agreement subsequent to the
filing of the ANDA in the United States, then: (i) such termination
shall be without penalty or liability to KRYPTON; (ii) all rights
and licenses granted by GENTA JAGO hereunder shall revert to GENTA
JAGO with respect to such country(ies) so terminated; (iii) KRYPTON
shall be relieved of any payments that are scheduled or may be made
in the future under this Agreement, (iv) KRYPTON shall return to
GENTA JAGO all materials, documentation, information, data and other
things furnished by GENTA JAGO in connection with this Agreement,
including without limitation any and all Confidential Information,
together with all copies thereof in KRYPTON's possession or under
its control, (v) GENTA JAGO and its Affiliates shall thereafter be
entitled to make, have made, use or sell the Product in the
country(ies) so terminated (and, provided, that the foregoing shall
not create or imply any right or license under any patent rights,
copyright rights, trademarks or trade names, know-how, or other
intellectual property rights owned or controlled by KRYPTON or its
Affiliates); (vi) all Registrations pertaining to the Product shall
be transferred to and be owned by GENTA JAGO as to the affected
country(ies) and the data generated hereunder shall be provided to
and thereafter may be freely used by GENTA JAGO to develop,
manufacture and market the Product; and (vii) GENTA JAGO shall pay
to KRYPTON the same royalty, which shall be paid in the same manner
and subject to the same terms and conditions as would otherwise have
applied to KRYPTON, as KRYPTON would otherwise have paid (absent
such termination) hereunder to GENTA JAGO on Net Sales (or on the
Gross Margin of such Net Sales, as the case may be) of the Product
in the country(ies) to which such termination applies (with such
royalty to be paid by GENTA JAGO and its Affiliates in each such
country until expiration of the Royalty Term in each such country),
until such time as the royalties paid to KRYPTON equal the aggregate
amount that had been paid by KRYPTON to GENTA JAGO prior to such
termination under the Sections 3.5, 4.3, 5.2, 6.3, 7.3,8.3, 9.2 and
13., at which time the royalty rate then prevailing on Net Sales (or
on the Gross Margin of such Net Sales, as the case may be) in the
United States shall be reduced by two percent (2 %) (but shall not
be reduced for sales outside the United States).
(c) Otherwise the termination of this Agreement shall be without
prejudice to any rights and obligations of either Party accrued
prior to the effective date of termination. KRYPTON shall forthwith
make all payments due and outstanding to GENTA JAGO at the date of
termination. Except as explicitly otherwise stated in this
Agreement, GENTA JAGO shall not be obligated to refund upon
termination of this Agreement to KRYPTON any payments, including
without limitation the *, made by KRYPTON to GENTA JAGO prior to
such termination pursuant to the provisions of this Agreement.
(d) The termination of this Agreement pursuant to Section 17.3 above by
either Party shall not limit remedies which may be otherwise
available in law or equity to either Party.
- 24 -
17.5 Early Termination of the License Agreements
(a) In the event that the License Agreements are terminated prior to the
expiration of the last to expire of the Patents licensed to GENTA
JAGO in the Territory, then the License granted hereunder to KRYPTON
shall also terminate upon KRYPTON's receipt of the respective
termination notice from the Licensor. KRYPTON may give written
notice to the Licensor of KRYPTON's desire to continue the License
granted under this Agreement within sixty (60) days as of KRYPTON's
receipt of the Licensor's notice referred to above.
(b) In the event that KRYPTON timely notifies the Licensor of its desire
to continue the License granted under this Agreement, the Licensor
shall have the right, at its sole discretion, to elect to assume in
writing within sixty (60) days upon the Licensor's receipt of
KRYPTON's notice any and all rights of GENTA JAGO under this
Agreement and to promptly cure all defaults of GENTA JAGO under this
Agreement, if any.
(c) In the event that the Licensor does not timely gives notice to
KRYPTON and cures all of GENTA JAGO's defaults hereunder pursuant to
Section 17.5(b) above, then KRYPTON shall promptly assume in writing
any and all rights and obligations of GENTA JAGO under the License
Agreements with the Licensor, but with regard to the rights
encompassed by the License granted hereunder only, and promptly cure
all defaults of GENTA JAGO under the License Agreements with regard
to the rights encompassed by the License granted hereunder only, if
any.
(d) Notwithstanding anything contained in this Section 17.5, no action
taken by the Licensor and/or KRYPTON to continue or not to continue
the License shall relieve GENTA JAGO from any liability for any
uncured defaults under this Agreement or the License Agreements, and
such action by the Licensor and/or KRYPTON shall be without
prejudice to any other rights or remedies the Licensor and/or
KRYPTON may have in law or equity.
ARTICLE 18
WARRANTIES
18.1 GENTA JAGO shall carry out and undertake the studies and tests specified
in this Agreement in a careful and diligent manner. GENTA JAGO agrees to
carefully choose, instruct and supervise any employees, officers,
Affiliates or third parties to be chosen by GENTA JAGO pursuant to this
Agreement, who are involved with the tests and studies. Nothing in this
Agreement shall be construed as a representation made, or warranty given,
by GENTA JAGO that any development performed by or for GENTA JAGO under
this Agreement will be successful in whole or in part, or that any
product, including Final Product, which may be developed, will be
successful in the commercial marketplace. Furthermore, GENTA JAGO makes no
representation or warranty, express or implied,
- 25 -
with respect to GEOMATRIX(R) Technology and/or Know-How, including without
limitation, any warranty of completeness, accuracy, merchantability or
fitness for a particular purpose thereof.
18.2 GENTA JAGO represents and warrants that it has all rights regarding
Patents, GEOMATRIX(R)Technology and Know-How necessary to grant the
License hereunder. Notwithstanding the preceding sentence, GENTA JAGO does
not assume any responsibility and makes no warranty that the performance
of this Agreement and any product developed hereunder, including Prototype
Formulation(s) and Final Products, do not infringe any third party's
patents, patent applications or other intellectual property rights.
Notwithstanding the preceding sentence, GENTA JAGO represents and warrants
that, as of the effective date of this Agreement, it is not aware and has
not knowledge of any such infringement of any third party rights. If,
however, during the course of this Agreement either Party discovers that
the Prototype Formulation(s) and/or the Final Products infringe or may
infringe any third party's intellectual property rights, it shall promptly
inform the other Party thereof and the Parties shall meet to discuss the
course of action to be taken with regard thereto.
18.3 Nothing in this Agreement shall be construed as a representation made, or
warranty given by GENTA JAGO that any patent will issue based upon any
pending patent application encompassed by the term Patents, and that any
patent encompassed by the term Patents which issues will be valid or
enforceable.
18.4 GENTA JAGO assumes no liability or responsibility for any damages caused
to KRYPTON, third parties, animals and/or the environment by the
manufacturing, marketing or use of the Prototype Formulations or Final
Products or the active ingredient contained therein, except to the extent
that any of the above are attributable to the gross negligence or willful
misconduct of GENTA JAGO in performing its obligations hereunder.
18.5 Subject to the specific representations and warranties given and specific
disclaimers of representations and warranties included in this Article 18,
and further subject to anything to the contrary contained in this
Agreement, either Party shall, as to third parties, be indemnified and
held harmless by the other Party from and against any and all losses,
liabilities and damages arising from any claim, action or other proceeding
by any third party relating to any acts or omissions of the other Party,
its directors, officers, employees or agents, or the gross negligence or
willful misconduct of such other Party, its directors, officers, employees
or agents in performing any of its obligations under this Agreement.
- 26 -
18.6 Any liability, warranty and undertaking contained herein shall be limited
to the payment by either Party for direct damages to the other Party and
in any event, neither Party shall be liable to the other Party for any
special, indirect, punitive or consequential damages and/or loss of
profits or anticipated profits, respectively.
18.7 KRYPTON shall, at its own expense, purchase from an insurance company of
its choice and shall maintain during the entire term of this Agreement an
appropriate and customary policy of general liability and product
liability insurance covering its responsibilities regarding Prototype
Formulation(s) and Final Products developed, manufactured, marketed and
sold under this Agreement and the Active Ingredient contained therein and
the use thereof. Upon request, KRYPTON shall provide GENTA JAGO with
evidence that such insurances are existing and are maintained.
ARTICLE 19
MISCELLANEOUS PROVISIONS
19.1 Entire Agreement: The terms, covenants, conditions and provisions
contained in this Agreement, including its Appendices referred to herein,
constitute the total and complete agreement of the Parties and supersede
all prior understandings and agreements hereto made, and there are no
other representations, understandings or agreements relating to the
subject matter hereof. The provisions of this Agreement may not be waived,
altered, amended or repealed in whole or in part except by the written
consent of both of the Parties to this Agreement.
19.2 Assignment: This Agreement may not be assigned or otherwise transferred,
nor, except as expressly provided hereunder, may any right or obligation
hereunder be assigned or transferred by either Party, other than to an
Affiliate of such Party, without the consent of the other Party; provided
however, that either Party may, without such consent, assign this
Agreement and its rights and obligations hereunder in connection with the
transfer or sale of all or substantially all of its business, or in the
event of its merger, consolidation, change in control or similar
transaction; and provided further that GENTA JAGO may without the consent
of KRYPTON assign any and all of its rights and obligations hereunder to
the Licensor and/or any of the Licensor's Affiliates. Any permitted
assignee shall assume all obligations of its assignor under this Agreement
or under the respective rights or obligations actually assigned.
19.3 Successors : This Agreement and all rights hereunder shall ensure to the
benefit of all successors and assigns of both Parties.
19.4 Notices: Any consent, notice or report required or permitted to be given
or made under this Agreement by one Party to the other shall be in English
and in writing, delivered personally or by courier service or by facsimile
(promptly confirmed by personal delivery or courier service) addressed to
the other Party at its address indicated below, or to such
- 27 -
other address as shall have been notified in writing to the sending Party
by the receiving party from time to time, and shall take effect upon
receipt by the addressee.
IF TO KRYPTON: KRYPTON LTD.
East Wing, Second Xxxxx
Xxxxxxxx Xxxxx
Xxxxxxx Xxxxxx
Xxxxxxxxx
attn.: PRESIDENT
WITH COPIES TO: SKYEPHARMA PLC
000 Xxxxxxxxxx
Xxxxxx X0X 0XX, Xxxxxxx
attn.: COMPANY SECRETARY
AND: XXXXXXXXXXXX XXXXX & XXXXXXXXXXX
Xxxxxxxxxxxxxxxx 0
X.X. Xxx 0000
XX-0000 Xxxxxx, Xxxxxxxxxxx
attn.: XX. XXXXXX X. XXXXXXXXXXXX
IF TO GENTA JAGO: GENTA JAGO Technologies B.V.
Swiss Branch
Xxxxxxxxxxxx 00
XX-0000 Xxxxxxxx, Xxxxxxxxxxx
attn..: MANAGEMENT COMMITTEE
WITH COPIES TO: XXXXXXXXXXXX XXXXX & XXXXXXXXXXX
Xxxxxxxxxxxxxxxx 0
0000 Xxxxxx, Xxxxxxxxxxx
attn.: XX. XXXXXX X. XXXXXXXXXXXX
AND: PILLSBURY MADISON & SUTRO LLP
000 Xxxxxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxxxxxxx, XX 00000, X.X.X.
attn.: XXXXXX X. XXXXXX, XX., ESQ.
19.5 Independent Contractors: It is expressly agreed that the Parties shall be
independent contractors and that the relationship between the Parties
shall not constitute a partnership, joint venture or agency. Neither Party
shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on
the other Party, without the prior written consent of the other Party to
do so.
- 28 -
19.6 Severability: Each Party hereby acknowledges that it does not intend to
violate any public policy, statutory or common laws, rules, regulations,
treaty or decision of any government agency or executive body thereof of
any country or community or association of countries. Should one or more
provisions of this Agreement be or become invalid, the Parties hereto
shall substitute, by mutual consent, valid provisions for such invalid
provisions which valid provisions in their economic effect are
sufficiently similar to the invalid provisions that it can be reasonably
assumed that the parties would have entered into this Agreement with such
provisions. In case such provisions cannot be agreed upon, the invalidity
of one or several provisions of this Agreement shall not affect the
validity of this Agreement as a whole, unless the invalid provisions are
of such essential importance to this Agreement that it is to be reasonably
assumed that the Parties would not have entered into this Agreement
without the invalid provisions.
19.7 Force Majeure: Neither Party hereto shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of
this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party including but
not limited to fire, floods, embargoes, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority or the other Party hereto.
19.8 Interest: In the event any amount due and payable under this Agreement is
not paid by the due date, then the Party owing such amount shall pay to
the creditor, without being requested by the other Party, interest on the
total outstanding amount at the rate equal to the London Interbank Offered
Rate ("LIBOR"), as published in the Wall Street Journal (Europe) on the
date that such payment falls due, increased by three percent (3%), in
United States Dollars and adjusted on the first day of every calendar
quarter.
19.9 Headings: The titles and headings used in this Agreement are intended for
convenience only and shall not in any way affect the meaning or
construction of any provision of this Agreement.
19.10 Waiver: The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by
said other Party whether of a similar nature or otherwise.
19.11 Counterparts: This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
- 29 -
ARTICLE 20
DISPUTE RESOLUTION AND ARBITRATION
20.1 In the event of any dispute arising between the Parties concerning this
Agreement, GENTA JAGO and KRYPTON agree that in the first place they shall
meet for good faith discussions in an attempt to negotiate an amicable
solution.
20.2 Any dispute arising between the Parties out of or in connection with this
Agreement, or the interpretation, breach or enforcement thereof, which
cannot be amicably resolved pursuant to Section 20.1 above within two (2)
months as from the first appearance of such dispute, shall be finally
resolved by binding arbitration. Whenever a Party shall decide to
institute arbitration proceedings, it shall give written notice to that
effect to all of the other Parties. Any arbitration hereunder shall be
conducted under the Rules of Conciliation and Arbitration of the
International Chamber of Commerce. Any such arbitration shall be conducted
in the English language by a panel of three (3) arbitrators appointed in
accordance with such rules, and shall be held in PARIS, FRANCE. The
arbitrators shall have the authority to grant specific performance, and to
allocate among the parties the costs of arbitration in such equitable
manner as they determine. Judgment upon the award so rendered may be
entered in any court having jurisdiction or application may be made to
such court for judicial acceptance of any award so rendered and an order
of enforcement, as the case may be. Whether a claim, dispute or other
matter in question would be barred by the applicable statute of
limitations, which also shall apply to any arbitration under this section,
shall be determined by binding arbitration pursuant to this section.
20.3 Notwithstanding anything contained in this Article 20, either Party may
seek preliminary or injunctive measures or relief in any competent court
having jurisdiction.
ARTICLE 21
APPLICABLE LAW
The Parties hereto agree that this Agreement, all transactions
executed hereunder and all relationships between the Parties in
connection therewith shall be construed under and be governed by the
laws of Switzerland without reference to the conflict of law
principals thereof, and shall not be governed by the United Nations
Convention on Contracts for the International Sale of Goods.
- 30 -
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the 31st day
of October 1996.
GENTA JAGO TECHNOLOGIES B.V.
/s/ Xxxxxx X. Xxxxx /s/ Xxxxxxx Xxxxxxx
------------------------ --------------------------
By Xx. Xxxxxx X. Xxxxx By: Xx. Xxxxxxx Xxxxxxx
Its: Managing Director Its: Managing Director
KRYPTON LTD.
/s/
-----------------------
By:
Its:
The Licensor, Jagotec AG, hereby agrees to be bound by the obligations contained
in Section 17.5 of this Agreement.
JAGOTEC AG
/s/ Xxxxxxx Xxxxxxx /s/
-------------------------- --------------------------
By: By:
Its: Its:
- 31 -
