EXHIBIT 10.91
CONFIDENTIAL TREATMENT REQUESTED
OPTION , DEVELOPMENT & SUB-LICENSE AGREEMENT
*
This OPTION, 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")
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 product(s) containing * as the sole active
ingredient; and
WHEREAS, KRYPTON is a company which markets pharmaceutical products and is
interested in developing Prototype Formulations (as defined below) for the Final
Products (as defined below) and in seeking the approval of Regulatory
Authorities (as defined below) to manufacture, or have manufactured and market
the Final Products 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 Products; and
WHEREAS, GENTA JAGO is prepared to grant to KRYPTON under the terms and
conditions set forth hereafter an option to 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 Products 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 *.
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 "FDA" shall mean the U.S. Federal Food and Drug Administration and any
successor agency thereof.
1.4 "Final Products" shall mean the pharmaceutical orally-administered
controlled-release formulation containing the Active Ingredient, presented
as a compressed tablet developed pursuant to this Agreement, based on the
GEOMATRIX(R) Technology and meeting the Specifications.
1.5 "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.
1.6 "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.
1.7 "Leading Dose Strength" shall mean the dose strength of Active Ingredient
to be used in the first to be developed Prototype Formulations, as mutually
agreed upon by the Parties, together with the respective Specifications.
1.8 "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.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
1.9 "Licensor" shall mean Jagotec AG, a Swiss corporation, having its place of
business at Xxxxxxxxxx 00, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx.
1.10 "NDA" shall mean any New Drug Application filed with the FDA, by or for
KRYPTON requesting authorization to manufacture, have manufactured or sell
any Final Product in the United States of America, or any equivalent
application to a Regulatory Authority in any other country of the
Territory.
1.11 "Net Sales" shall mean, with respect to any Final Product(s), the invoiced
sales price of --------- such Final Product(s) 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 chargebacks from the account of, such independent customers
for spoiled, damaged, out-dated, rejected or returned Final Product(s); (b)
actual freight and insurance costs incurred and paid by KRYPTON and/or its
Affiliates in transporting such Final Product(s) 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(s) in final form.
1.12 "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 Products 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.
1.13 "Prototype Formulations" shall mean the oral delivery system for both, the
Leading Dose Strength and the Subsequent Dose Strength, of Active
Ingredient based on the GEOMATRIX(R) Technology that reasonably meet the
Specifications.
1.14 "Reference Products" shall mean the products containing Active Ingredient
listed in APPENDIX B.
1.15 "Regulatory Authority" shall mean the FDA and any equivalent competent
regulatory authority in the other countries of the Territory.
1.16 "Specifications" shall mean the Product specifications to be mutually
decided and agreed upon by the Parties for the Leading Dose Strength and
the Subsequent Dose Strength and as set forth from time to time in
Appendixes to this Agreement.
-3-
1.17 "Subsequent Dose Strength" shall mean the dose strength of Active
Ingredient to be used in Prototype Formulations to be developed hereunder
subsequent to the Prototype Formulations for the Leading Dose Strength, as
mutually agreed upon by the Parties, together with the respective
Specifications, at the appropriate time.
1.18 "Territory" shall mean *.
ARTICLE 2
GRANT OF OPTION AND DEVELOPMENT PREAMBLE
2.1 GENTA JAGO hereby grants to KRYPTON an exclusive option to develop and to
acquire a sub-licensese (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 as
further set forth hereinafter. This option may be exercised by KRYPTON in
writing at any time on or before the earlier of (i)* or (ii) within *. Upon
timely exercise of this option the terms and provisions set forth
hereinafter for the development, registration and sub-license for the Final
Products shall come into full force and effect. Should KRYPTON not timely
exercise its option granted hereunder or inform GENTA JAGO in writing that
KRYPTON does not wish to exercise the option, then GENTA JAGO shall be free
to develop, sub-license and market the Final Products for its own purposes
or for and to any other third party.
2.2 The Parties agree that upon KRYPTON's exercise of the option granted in
Section 2.1. above GENTA JAGO shall commence the development of Prototype
Formulations for the Leading Dose Strength pursuant to this Agreement.
During the term of this Agreement, KRYPTON shall have a further option of
whether or not and when to commence development of Prototype Formulations
for the Subsequent Dose Strength by giving written notice to that effect to
GENTA JAGO. If and when KRYPTON so elects and GENTA JAGO so agrees, than
the terms and conditions for the development as set forth hereinafter shall
apply accordingly to the Prototype Formulations for the Subsequent Dose
Strength, except where explicitly stated otherwise below.
2.3 At the date of execution of this Agreement, GENTA JAGO has performed
certain preliminary development efforts for the Prototype Formulations.
This development is hereby incorporated in this Agreement.
2.4 GENTA JAGO undertakes to conduct the development of the Prototype
Formulation(s)
-4-
and the Final Product(s) 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 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 Reference Products for
the purposes of conducting the Feasibility Study. KRYPTON, however, shall
not be required to provide information regarding the Reference Products
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.
2.5 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 in this Agreement and/or the time-frame of the development 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-frames mutually agreed upon.
2.6 Together with the notice from KRYPTON to GENTA JAGO 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 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 reimburse all direct costs 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.
2.7 In the event that GENTA JAGO becomes responsible for the supply of Active
Ingredient, KRYPTON shall * related thereto and shall further reimburse
GENTA JAGO any and all shipping and transportation costs, import duties,
taxes or other
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-5-
costs incurred by GENTA JAGO in connection with such supply of Active
Ingredient promptly upon receipt of GENTA JAGO's respective invoices.
ARTICLE 3
FEASIBILITY STUDY
3.1 By the notice of exercise of the option granted in Section 2.1 above from
KRYPTON the development program contemplated hereunder shall be initiated.
Not later than two (2) months as of the receipt of (i) such notice, (ii) a
* 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.
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.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-6-
3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit
to KRYPTON a * 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 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 a * 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 *
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-7-
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 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 a * 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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-8-
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.
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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-9-
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
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 a * 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 *
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-10-
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 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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-11-
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 * 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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-12-
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.
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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-13-
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 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,
-14-
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 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 regar- ding, 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
-15-
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 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:
(i) to cover any and all costs and expenses (including attorney's fees)
incurred by the
-16-
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 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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-17-
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 granting the option hereinbefore set forth
KRYPTON undertakes to pay to GENTA JAGO an *, payable upon execution of
this Agreement.
13.2 Provided that KRYPTON shall exercise the option granted hereunder, 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 *
13.3 The * shall be payable *:
(a) * KRYPTON's receipt of
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-18-
GENTA JAGO's notice referred to in Section 7.1 above; and
(b) *; and
(c) * for the Final Product; and
(d) * for Final Product.
13.4 The Parties agree that * as set forth in Section 14.4 below.
13.5 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 Products in the Territory.
14.2 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 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, * of the Final Product on a country-by-country and
product-by-product basis to which the Royalty payment relates.
14.3 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.
14.4 In recognition of the * payable by KRYPTON to GENTA JAGO prior to the
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-19-
commercial sale of the Final Products, the amount of Royalty payments due
to GENTA JAGO under Article 14.2 above with respect to each calendar
quarter shall be * until such time as the aggregate amount of all *
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 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.
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.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-20-
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 Products, 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. The
Parties further agree that no public announcements or press releases shall
be made prior to the exercise of the option granted hereinbefore.
16.4 Term of Confidentiality
-21-
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 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 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.
ARTICLE 17
TERM AND TERMINATION
17.1 Term and Expiration
(a) This Agreement shall expire on a country-by-country and
product-by-product 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 by KRYPTON for any reason and without cause, 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:
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-22-
(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.
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
-23-
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.
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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-24-
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, 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
-25-
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.
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
-26-
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 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
-27-
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.
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.
-28-
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.
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
-29-
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.
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
-------------------
by: by:
its: its:
-30-
