Exhibit 10.94
CONFIDENTIAL TREATMENT REQUESTED
DEVELOPMENT & SUB-LICENSE AGREEMENT
DICLOFENAC
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 ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (hereinafter referred to as "GENTA JAGO"), and KRYPTON
LTD., a Gibraltar limited company, having a place of business at East Wing,
Second Level, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ (hereinafter referred to
as "KRYPTON")
WITNESSTH:
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 with 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 Diclofenac.
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
allocatable overhead cost (e.g. energy cost), (d) packaging and
labeling cost, and (e) other costs directly associated with the
manufacturing of such Final
-2-
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 ▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇.
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 governmentl
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 process to manufacture
Prototype Formulations and/or Final Product by use of, or the
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
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.
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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-4-
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) * and (iii) the Active Ingredient,
GENTA JAGO shall commence the feasibility study under 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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-5-
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.
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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-6-
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 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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-7-
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 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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-8-
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 the * 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 detailling
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 resupect 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.
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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-9-
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 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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-10-
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.
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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-11-
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.
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.
-12-
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.
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
-13-
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 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 ▇▇▇▇▇ the infringement of, or
defend third-party actions regarding, GENTA JAGO IPR, (ii)
-14-
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 ▇▇▇▇▇ 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.
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 ▇▇▇▇▇ 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
-15-
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 ▇▇▇▇▇ 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 ▇▇▇▇▇ 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:
(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,
-16-
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 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,
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-17-
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) * 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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-18-
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 (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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-19-
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.
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.
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-20-
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 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
-21-
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
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.
-22-
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.
(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
-23-
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.
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
-------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-24-
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, 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.
-25-
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.
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
-26-
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 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 ▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇
attn.: PRESIDENT
WITH COPIES TO: SKYEPHARMA PLC
▇▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇
attn.: COMPANY SECRETARY
AND: ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇
▇.▇. ▇▇▇ ▇▇▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
attn.: ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇
IF TO GENTA JAGO: GENTA JAGO Technologies B.V.
Swiss Branch
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇▇-▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
attn..: MANAGEMENT COMMITTEE
WITH COPIES TO: ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇
▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇
attn.: ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇
-27-
AND: PILLSBURY MADISON & SUTRO LLP
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇.▇.▇.
attn.: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇., 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.
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.
-28-
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.
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.
-29-
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.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the 31st day
of October 1996.
GENTA JAGO TECHNOLOGIES B.V.
/s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------- -------------------
by ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ by: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ /s/
------------------- ------------------------
by: by:
its: its
-30-
