EXHIBIT 10.90
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CONFIDENTIAL TREATMENT REQUESTED
LICENSE AGREEMENT
THIS AGREEMENT, is made as of the Effective Date (as defined below), by
and between APOTHECON, INC., a Delaware corporation with offices at 000 Xxxxxxxx
Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000, XXX (hereinafter referred to as
"APOTHECON"), and GENTA JAGO TECHNOLOGIES BV, a Dutch company, having offices at
Xxxxxxxxxxxx 00, 0000 Xxxxxxxx, Xxxxxxxxxxx (hereinafter referred to as "GJT").
RECITALS
WHEREAS, GJT has the expertise and skill needed to develop
pharmaceutical preparations in * formulation of * (hereinafter, as more fully
defined below, referred to as the "Product"); and
WHEREAS, GJT (i) is the exclusive licensee of Jagotec AG, a Swiss
corporation, of certain patent rights covering the GEOMATRIX formulation of the
Product and (ii) is in possession of certain know-how and technology regarding
the development, production and analytical methods of the Product (hereinafter,
as more fully defined below, referred to as "Know-how");
WHEREAS, APOTHECON is interested in developing and marketing the
Product throughout the world and receiving an exclusive license under the
relevant GEOMATRIX patent rights and Know-how for such purpose, and GJT is
willing to grant such exclusive license to APOTHECON, all upon the terms and
conditions set forth below.
WHEREAS, the terms and conditions governing the research, development,
manufacture, and marketing of the Product are set forth in a separate agreement
of even date herewith between GJT and APOTHECON (said agreement, as the same may
be extended, supplemented or changed hereafter, referred to hereinafter as the "
Development and Marketing Agreement").
NOW, THEREFORE, in consideration of the above premises and the mutual
promises and covenants set forth herein, the parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms as used in this Agreement shall have the meanings
set forth in this Article 1:
* that (i) where marketed within the United States, is classified by
FDA as an * under the Federal Food, Drug and Cosmetic Act, as amended, and (ii)
where marketed outside the United States, is classified, marketed and/or
designated as a *.
"Adverse Drug Reaction (ADR)" shall have the meaning ascribed to such
term under applicable law, but in any event shall include any reaction, side
effect or other undesirable event (such as side effects, injuries, toxicity or
sensitivity reaction, or any unexpected incidence and the severity thereof) that
is associated with the use of the Product in humans, whether or not the event is
considered drug related, including, but not limited to, the following: an
adverse event occurring in the course of the use of the Product in professional
practice, including use in clinical studies; drug overdose, whether accidental
or intentional; an adverse event occurring from drug abuse; an adverse event
occurring from drug withdrawal; any significant failure of expected
pharmacological or biological actions; and any adverse event associated with the
clinical use, study, investigation, testing and marketing of the Product or any
other product (to the extent such adverse event pertains to the use or
incorporation of the GEOMATRIX Technology in such product). In addition, when an
ADR is herein referred to as "serious", it shall have the
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meaning ascribed to such term under applicable law, but in any event shall
include one or more of the following: death; admission to a hospital or
prolongation of a hospital stay; permanent or substantially disabling condition;
life- threatening condition; overdose; congenital anomaly; or cancer. Also, when
an ADR is herein referred to as "unexpected", it shall have the meaning ascribed
to such term under applicable law, but in any event shall include (x) for a
non-marketed product, an experience that is not identified in nature, severity
or frequency in the current clinical investigator's confidential information
brochure, and (y) for a marketed product, an experience which is not listed in
the current labeling for such product, and includes an event that may be
symptomatically and pathophysiologically related to an event listed in the
labeling but differs from the event because of increased frequency or greater
severity or specificity.
"Affiliate" means, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under common control
with, such Person. A Person shall be regarded as in control of another Person if
it/he/she owns, or directly or indirectly controls, fifty percent (50%) or more
of the voting stock or other ownership interest of the other Person, or if
it/he/she directly or indirectly possesses the power to direct or cause the
direction of the management and policies of the other Person by any means
whatsoever. For example, Jagotec and Jago Pharma AG are Affiliates of GJT.
"Developmental Program" shall mean a development program in which the
different activities to be performed by GJT and APOTHECON shall be listed
(together with a respective time schedule for the development of the Product to
be carried out by GJT and/or APOTHECON), as the case may be, according to such
"Project Addendum" (and as amended or supplemented by mutual written agreement
from time to time hereafter), with the initial Project Addendum attached as
Exhibit 1.1(i) to the * Development and Marketing Agreement.
"Effective Date" means the date when this Agreement is executed and
delivered by both parties hereto, and (i) APOTHECON shall have received duly
executed originals of all Waivers and Consents required under Section 3.6
hereof, (ii) all opinions of counsel contemplated by section 3.7 hereof have
been received by APOTHECON, and (iii) Jagotec and Jago Pharma shall have duly
executed the acknowledgment on the signature page of this Agreement.
"...exclusive....."means, with respect to the grant of a license or
sublicense, or to the appointment of a distributor, a license, sublicense, or
appointment whereby the licensee's, sublicensee's or appointee's rights are sole
and entire, and operate to exclude all others, including the licensor,
sublicensor and appointor, as the case may be, and may be exercised by the
licensee or sublicensee itself or through one or more of its Affiliates. An
exclusive licensee (and permitted sublicensees) may sell and distribute Products
through agents and distributors under exclusive or nonexclusive arrangements in
any country in the Territory. "...semi-exclusive....," with respect to the grant
of a license or sublicense, or to the appointment of a distributor, shall be
interpreted in the same manner as the preceding sentence, except that the
licensor, sublicensor or appointor, as the case may be, may also use the
licensed, sublicensed or appointed rights itself or through one or more of its
Affiliates.
"FDA" shall mean the United States Food and Drug Administration, or any
successor agency having regulatory jurisdiction over the manufacture,
distribution and sale of drugs in the United States.
"First Commercial Sale" shall mean, with respect to any Product, the
first sale for use or consumption by the general public of such Product in a
particular country in the Territory after the required marketing approval and
pricing approval, if any, has been granted by the governing health authority of
such country.
"GEOMATRIX Agreements" means the GEOMATRIX License Agreement, the
GEOMATRIX Manufacturing License Agreement, the GEOMATRIX Supply Agreement, and
the GEOMATRIX Research and Development Agreement (each, individually, a
"GEOMATRIX Agreement").
"GEOMATRIX License Agreement" shall mean the Restated GEOMATRIX License
Agreement dated as of May 12, 1995 between GJT and Jagotec.
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"GEOMATRIX Manufacturing License Agreement" shall mean the Restated
GEOMATRIX Manufacturing License Agreement dated as of May 12, 1995 between GJT
and Jagotec.
"GEOMATRIX Research and Development Agreement" means the Restated
GEOMATRIX Research and Development Agreement dated as of May 12, 1995 by and
among GJT, Jago Pharma AG, a Swiss corporation, Genta Incorporated, a Delaware
corporation, and Genta Jago Delaware, L.L.C., a Delaware limited liability
company.
"GEOMATRIX Supply Agreement" means the Restated GEOMATRIX Supply
Agreement dated as of May 12, 1995 by and among GJT and Jago Pharma AG, a Swiss
corporation.
"GEOMATRIX Technology" means all oral controlled-release drug delivery
and related technology which utilizes a hydrophilic drug-containing matrix *
which controls the release of the drug through the use of one or more barrier
layers, together with all improvements thereon and thereto, all to the extent
and only to the extent that GJT now has or hereafter will have the right to
grant licenses, immunities or other rights thereunder.
"Gross Margin" shall have the meaning ascribed to such term in Section
7.2.2 hereof.
"Jagotec" means Jagotec AG, a Swiss corporation, having a place of
business at Xxxxxxxxxx 00, XX0000 Xxxxxxxxx, Xxxxxxxxxxx.
"Jago Pharma" means Jago Pharma AG, a Swiss corporation, having a place
of business at Xxxxxxxxxxxxxxx 00, XX-0000 Xxxxxxx, Xxxxxxxxxxx.
"* Development and Marketing Agreement" has the meaning ascribed to
such term in the recitals above.
"Know-how" means all information and data, which is not generally
known, including, but not limited to, formulae, procedures, protocols,
techniques, preclinical and clinical developmental and technical data, and
results of experimentation and testing, which (a)(i) relate to the GEOMATRIX
Technology or the Product, or the manufacture or use of same, or (ii) are
necessary or useful to develop, make, use, sell or seek regulatory approval in a
country in the Territory to make, use or sell the Product, and (b) are developed
or acquired by or are under the control of a party to this Agreement.
"Manufacturing Cost" shall mean the cost to APOTHECON and its
Affiliates of * by APOTHECON or such Affiliates in the manufacture of all
products produced in the facility or facilities in which the Product is
manufactured. If the Product is manufactured in whole or in part by an
unaffiliated Third Party, the costs to be taken into account shall be the amount
paid to such Third Party plus any of the aforementioned costs that are incurred
in completing the manufacture and delivery of the Product.
"Net Sales" shall mean the applicable quantity of Product times "Net
Sales Price." It shall be determined at the point of sale from APOTHECON (or
from such of its Affiliates to whom APOTHECON may sell such Product) to a Person
not Affiliated with APOTHECON.
"Net Sales Price" of Product shall mean the invoiced sales price of the
Product billed to independent customers of APOTHECON who are not its Affiliates,
less (to the extent incurred and absorbed by APOTHECON or its Affiliates): (a)
credits, allowances, discounts and rebates to, and chargebacks from the account
of, such independent customers for spoiled, damaged, out-dated, rejected or
returned Product; (b) actual freight and insurance costs in transporting the
Product in final form to such customers; (c) cash, quantity and trade discounts,
rebates, and other price adjustments or price reduction programs; (d) sales,
use, value-added and other direct taxes,
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or any other governmental charge imposed upon the production, importation, use
or sale of the Product; (e) customs duties, surcharges and other governmental
charges in connection with the exportation or importation of the Product in
final form; and (f) invoiced amounts with respect to the Product which are first
outstanding and unpaid for * or more during the applicable reporting period,
less such invoiced amounts outstanding and unpaid for * or more which are
received or recovered during such reporting period; provided that such amounts
under (f) shall not exceed * of APOTHECON during the term hereof.
Notwithstanding the foregoing, if any Product is sold under * arrangements,
then, prior to the First Commercial Sale of such Product and thereafter promptly
following the end of each calendar year, APOTHECON and GJT shall * the "Net
Sales Price' for sales of such Product under such * arrangements. Such formula
shall be based on such factors as the parties * and shall appropriately and
equitably allocate a sales price to Product sold under such * arrangements.
"Patent Rights" shall mean (a) all patent applications heretofore or
hereafter filed or having legal force in any country in the Territory owned by
or licensed to GJT or its Affiliates or to which GJT or its Affiliates otherwise
acquires rights, which claim the GEOMATRIX Technology or the Product, or the
process of manufacture or use of the GEOMATRIX Technology or the Product,
together with any and all patents that have issued or in the future issue
therefrom, including utility, model and design patents and certificates of
invention, including but not limited to those patent applications and patents
listed on Exhibit 1.1(ii) hereto, and (b) all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions, substitutions,
confirmations or additions to any such patents and patent applications; all to
the extent and only to the extent that GJT now has or hereafter will have the
right to grant licenses, immunities or other rights thereunder.
" Person" shall mean an individual, corporation, partnership, trust,
business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority, or any other form of entity not specifically listed herein.
"Product" shall mean a pharmaceutical composition containing *
(including all commonly used and known salts and acids thereof) which is an *,
and which incorporates, is based on and is derived by use of the GEOMATRIX
Technology.
"Region I" shall mean all *, and their respective territories and
possessions.
"Region II" shall mean all countries *, and their respective
territories and possessions.
"Region III" shall mean *, and their respective territories and
possessions.
"Region IV" shall mean all other countries of the world other than
those located in Regions I-III, and their respective territories and
possessions.
"Registration" shall mean any form and type of registration,
application, permit, license, authorization, approval, presentation or
notification being requested by any competent authorities, government or body in
a given country for the manufacturing, production, marketing, advertising,
distribution, sale, trade, import, export or use of the Products of such
authority, government or body, and shall include all acts, steps, applications,
presentations, statements or other things which are necessary or useful to
obtain the foregoing.
"Research and Development Costs" shall mean (a) the following costs
reasonably incurred by GJT relating to its development and Registration
responsibilities hereunder for the Product: raw materials, energy, direct labor
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(salary and benefits) and reasonable allocable direct (but not indirect)
overhead charges relating to the development and Registration of the Product,
plus (b) reasonable out-of-pocket or other expenses paid or accrued by GJT to
any Subcontractee performing any portion of such development and Registration,
provided that expenses paid to an Affiliate Subcontractee under this clause (b)
shall not exceed the amounts required to be paid under the GEOMATRIX Research
and Development Agreement. All such costs shall be determined and allocated in
accordance with generally accepted accounting principles, consistently applied.
"Royalty Term" shall mean, with respect to each Product in a given
country in the Territory in which the Product is sold by or through APOTHECON,
the term for which a Valid Patent Claim remains in effect, and which would be
infringed by the manufacture, use or sale of the Product in such country but for
the license rights granted to APOTHECON under this Agreement.
"Scale-Up" shall mean, with respect to the Product and a designated
Manufacturing facility, the process of developing a reliable and practical
method of manufacturing the Product in such designated manufacturing facility to
effectuate the orderly transition from laboratory production of the Product to
routine full-scale production of the Product in such designated facility in
quantities necessary for commercial sale. Without limitation, Scale-Up includes
(a) installation, evaluation and validation of the necessary equipment, (b)
establishment, evaluation, validation and finalization of the necessary
production and process controls, (c) demonstration of the ability to produce a
batch size of at least * of the proposed commercial production batch for the
Product at such facility, (d) demonstration of compliance with all other
applicable laws, regulations and good manufacturing practices, (e) production of
GMP bio-batches for pivotal clinical trials, and (f) transposition to routine
full scale production.
"Specifications" of the Product shall have the meaning set forth in
Section 4.2 of the * Development and Marketing Agreement.
"Subcontractee" shall have the meaning ascribed to such term in Article
14 of the * Development and Marketing Agreement.
"Territory" shall mean *.
"Third Party" means any Person other than GJT or APOTHECON, and
includes their respective Affiliates and sublicensees except as otherwise
specifically indicated.
"Valid Patent Claim" shall mean a claim of an issued and unexpired
patent included within the Patent Rights (or a claim under a patent application
within the Patent Rights that is being diligently prosecuted by GJT or its
Affiliates), which has not been held permanently revoked, or declared
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, .unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise (other than as required by applicable
law to initiate the reissue of a patent).
"Validated Manufacturing Scale-Up" shall mean, with respect to the
Product and a designated Manufacturing facility, a reliable and practical method
of manufacturing the Product in such designated manufacturing facility for
routine full-scale production of the Product in such designated facility in
quantities necessary for commercial sale. Without limitation, Validated
Manufacturing Scale-Up includes (a) installation, evaluation and validation of
the necessary equipment, (b) establishment, evaluation, validation and
finalization of the necessary production and process controls, (c) successful
demonstration and validation of the ability to produce GMP batch sizes equal to
one hundred percent (100%) of the proposed commercial production batch for the
Product at such facility, (d) demonstration of compliance with all other
applicable laws, regulations and good manufacturing practices, and (e)
transposition to routine full scale production.
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ARTICLE 2
OWNERSHIP OF RIGHTS
2.1 Ownership of Rights. GJT represents and warrants that:
2.1.1 (a) it has the exclusive license under all rights of any
nature regarding the Patent Rights which are the subject of
the license granted under Article 3 below, and
(b) it has the right to use, and to grant the licenses
hereunder to use, the Know-how which is the subject
of the license granted under Article 3 below,
in each case, whether protected or not by any valid registrations,
approvals or by any law or contract, and
2.1.2 it has not assigned, conveyed or otherwise encumbered by
any agreement, either oral or written, any right, title or interest in
and to the Patent Rights or Know-how which would be inconsistent with
the rights granted APOTHECON hereunder.
2.2 No Taking Subject To. Except as may be expressly set forth in this
Agreement, any sublicense or other rights granted APOTHECON hereunder are not
subject to the terms and conditions of the GEOMATRIX License Agreement, the
GEOMATRIX Manufacturing License Agreement, the GEOMATRIX Supply Agreement or the
GEOMATRIX Research and Development Agreement, and APOTHECON shall not be bound
by any obligations or undertakings of GJT under any of the aforesaid Agreements.
2.3 Enforcement of GEOMATRIX Agreements. [Intentionally omitted].
ARTICLE 3
GRANT OF LICENSE; BACK-UP SUPPLY; CONSENT AND WAIVER
3.1 Grant of License. GJT hereby grants to APOTHECON and APOTHECON
accepts, upon the terms hereinafter set forth:
3.1.1 a * license, with the right to grant sublicenses, under the
Patent Rights and Know-how, to research and develop Products for use in
the Territory in accordance with the * Development and Marketing
Agreement and this Agreement; and
3.1.2 an exclusive license, with the right to grant sublicenses,
under the Patent Rights and Know-how, to use, distribute, market and sell
Products in the Territory; and
3.1.3 subject to section 3.5 hereof, 8 license, with the right to
grant sublicenses, under the Patent Rights and Know-how to make and have
made the Product in the United States (or in its possessions or Puerto
Rico) for use or sale in the Territory.
Such rights shall continue until terminated in accordance with the terms of this
Agreement.
3.2 Supply of Product. [Intentionally omitted.]
3.3 Other Suppliers. [Intentionally omitted].
3.4 Initiation of Back-up Supply. [Intentionally omitted.]
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3.5 Sublicenses to Certain Third Parties. Notwithstanding anything to
the contrary in this Agreement, APOTHECON shall not sublicense any right and
license granted hereunder to any unaffiliated Third Party in order to make
Product whose research and development programs are primarily based on
controlled release-formulation technology, without the prior written consent of
GJT (not to be unreasonably withheld). APOTHECON shall deliver to GJT a copy of
each sublicense under the Agreement within ten (10) business days after
execution thereof (except that financial and marketing provisions and
information may be redacted), which GJT shall maintain in confidence pursuant to
Article 10 below. Any sublicense shall be subject to the terms and conditions of
the Agreement, and any sublicensee shall be bound by all obligations and
undertakings of APOTHECON hereunder (as they relate to the sublicensed rights).
3.6 Consent and Waiver Agreements. As a material inducement to
APOTHECON's willingness to enter into this Agreement, GJT will cause,
contemporaneously with the execution and delivery of this Agreement, each of the
Consent and Waiver Agreements in the form attached as Exhibits 3.6 (i)-(iv)
hereto to be executed and delivered to APOTHECON.
3.7 Opinions of Counsel. Contemporaneously with the execution and
delivery of this Agreement,GJT will deliver opinions of counsel to itself,
Jagotec and Jago Pharma AG, and an opinion of counsel to Genta Incorporated, in
form and substance satisfactory to APOTHECON.
ARTICLE 4
PRODUCT DEVELOPMENT
4.1 Information Exchange. Promptly following the Effective Date, each
party agrees, subject to conflicting third party rights, to promptly furnish the
other in writing all technical information and preclinical and clinical data
developed or acquired relating to the Product in the control or possession of a
party, including all information in the nature of improvements or modifications
to the aforesaid and all toxicological, analytical, chemical data, and the like.
All such information exchanged shall be treated as Confidential Information of
the disclosing party in accordance with the * Development and Marketing
Agreement.
4.2 Product Specifications. [Intentionally omitted].
4.3 APOTHECON Product Development Duties. [Intentionally omitted.]
4.4 GJT Product Development Duties. [Intentionally omitted.]
4.5 Development and Registration Reports. [Intentionally omitted].
4.6 Development Cost Funding. [Intentionally omitted].
ARTICLE 5
MANUFACTURE AND SUPPLY OF PRODUCT
5.1 Manufacture. [Intentionally omitted].
5.2 Product Registrations. [Intentionally omitted]
5.3 Manufacturing and Registration Reports. [Intentionally
omitted]
5.4 Product Purchase. [Intentionally omitted].
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5.5 Acceptance; Rejection of Initial Launch Quantity of Product in
Case of Non-Conformity. [Intentionally omitted.]
5.6 Process Changes. [Intentionally omitted].
5.7 Warranties. [Intentionally omitted.
5.8 Inspection. [Intentionally omitted].
5.9 [Intentionally omitted]
5.10 Payment Terms. [Intentionally omitted.]
ARTICLE 6
MARKETING
6.1 Packaging and Labeling. Intentionally omitted].
6.2 Commercialization.
6.2.1 Subject to Sections 6.2.4 and 6.2.5 below, in the event
that APOTHECON in the exercise of its sole discretion does not, either
through itself or an Affiliate, within * of the Product *, register or
file for regulatory approval to market the Product
i) *,
ii) *, and
iii) *
APOTHECON's * where APOTHECON failed to so register or file for such
regulatory approval, unless APOTHECON demonstrates why such filings
were not commercially feasible.
6.2.2 Subject to Sections 6.2.4 and 6.2.5, APOTHECON exclusive
rights under section 3.1.2 shall, at GJT's option, be converted to *
with respect to all countries located in a particular Region within
Regions I, II, III or IV where, having made the filings or
registrations required to be made under section 6.2.1 to maintain such
exclusivity in any such Region, APOTHECON thereafter fails to
diligently prosecute and pursue such regulatory approval for the
marketing of the Product for the number of (or specifically designated)
countries indicated in 6.2.1(i)-(iii) above (and with respect to Region
I, in the United States), unless APOTHECON demonstrates why continuing
such prosecution was not commercially feasible.
6.2.3 Upon obtaining all applicable Registrations to market
the Product for the number of (or specifically designated) countries
indicated in 6.2.1(i)-(iii) above for a given Region (and with respect
to Region I, in the United States), APOTHECON shall use its
commercially reasonable efforts to market, or to cause the marketing
and sales of, the Product for the number of (or specifically
designated) countries indicated in 6.2.1(i)-(iii) above for a given
Region (and with respect to Region I, in the United States), for so
long a period of time as APOTHECON considers it commercially feasible
to do so for such country(ies) in such Region. APOTHECON may, but shall
not be required, to consult with GJT regarding marketing and sales
strategies developed and applied by APOTHECON. APOTHECON shall be
responsible for all
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costs of marketing and sales of Products incurred by it. Subject to
Section 6.2.4, if APOTHECON ceases to use its commercially reasonable
efforts to market, or cause the marketing and sales of, the Product for
the number of (or specifically designated) countries indicated in 6.2.1
(i)-(iii) above for a given Region (and with respect to Region I, in
the United States), and if substantial steps are not taken by APOTHECON
to reverse same (should such efforts, in fact, have ceased) within
sixty (60) days following receipt by APOTHECON of written notice from
GJT stating that it believes such efforts to have ceased, then,
provided, that APOTHECON ceased such efforts and that it intends to
pursue conversion of APOTHECON's exclusive rights under section 3.1.2
to * with respect to such Region, such rights shall, at GJT's option,
be so converted.
6.2.4 Prior to any conversion of APOTHECON's rights from
exclusive to *, as provided for in each of Sections 6.2.1-6.2.3, GJT
shall give APOTHECON written notice of its intention Dto do so and a
detailed statement of the reasons therefor. APOTHECON shall have sixty
(60) days thereafter to reply in writing as to whether it will go along
with or disagrees with the proposed conversion. If APOTHECON disagrees,
it will provide a detailed statement of its reasons therefor. The
parties will meet and confer within 30 days thereafter to determine if
the difference can be resolved. If not so resolved, the matter will be
referred for resolution pursuant to the arbitration procedures set
forth herein.
6.2.5 An election by GJT to convert APOTHECON's exclusive
rights to * under any of sections 6.2.1-6.2.3 shall be GJT's sole and
exclusive remedy, and GJT shall be deemed to have released and waived
any claims or other causes of action, for and with respect to any and
all damages of any type or nature whatsoever arising out of or in
connection with the acts or omissions of APOTHECON or its Affiliates
entitling GJT to so convert.
6.3 Covenant Not to License a Competitor. [Intentionally omitted]
6.4 Adverse Drug Reactions. [Intentionally omitted]
6.5 Product Recall. [Intentionally omitted].
ARTICLE 7
MILESTONE AND ROYALTY PAYMENTS
7.1 Additional Payments. Subject to Article 11 hereof:
7.1.1 If the Product is the * with the Product), then
APOTHECON shall pay to GJT an *.
7.1.2 Upon demonstration of * to GJT; provided, that * at the
date of such demonstration.
7.2 Royalties. Subject to Article 11 hereof and to sections 4.7.2
and 8.4 of the * Development and Marketing Agreement,
Apothecon will pay GJT royalties of * during the Royalty Term,
subject to the following:
7.2.1 * on Product samples distributed by APOTHECON, it being
understood that such samples will be limited to use primarily in
situations involving promotional photograph
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and account demonstrations necessary to secure sales contracts, and will not, in
any event, exceed *.
7.2.2 If * in such country in the Territory, less the sum of
(i) packaging (in final form) and labeling costs for
the dosage form of the Product (with such costs, for purposes
of *, * plus
(ii) actual net distribution costs for the Product in
such country, with such * has been approved for marketing in
such country). Actual net distribution costs are defined as
* distribution costs for the Product in such country *, plus
(iii) APOTHECON's actual Manufacturing Costs for the
Product sold in such country, other than the costs already
taken into account under subsections 7.2.2(i) and (ii) above;
provided, however, that for purposes of only, APOTHECON agrees
that its actual Manufacturing Costs for the Product will *
following First Commercial Sale in the United States, by an
amount equal to the percentage change from the immediately
preceding January 1 in the Consumer Price Index for All Urban
Consumers, All Items (1986 = 100) (the "Index"), as published
by the U.S. Department of Labor (or successor index or
department).
7.2.3 All royalties shall cease for a given country in the
Territory upon the first to occur of the following: (i) the expiration
of the Royalty Term in such country; (ii) when the Product is no longer
being marketed by or through APOTHECON in such country; or (iii) upon
termination of this Agreement with respect to such country.
7.2.4 If the royalty rate specified in the Agreement should
exceed the permissible rate established in any country in the
Territory, the royalty rate for Net Sales in such country shall be
adjusted to the highest legally permissible or government-approved
rate.
7.3 Payment: Records; Audits
7.3.1 Payment; Reports. All royalty payments due under this
Agreement shall be paid in U.S. dollars within 60 days of the end of
each calendar quarter, unless otherwise specifically provided herein.
Each payment of royalties shall be accompanied by a report of Net Sales
of Products in sufficient detail to permit confirmation of the accuracy
of the royalty payment made.
7.3.1.1 Exchange Rate; Manner and Place of Payment.
Royalty payments and reports due pursuant to this Agreement
shall be calculated and reported for each calendar quarter.
Exchange conversion of foreign payments into U.S. Dollars
shall be made as necessary at the rate of exchange reported in
The Wall Street Journal as of the end of the fourth banking
day preceding the end of the applicable royalty period or, for
payments other than royalty payments, the fourth banking day
preceding the date of payment. All payments owed under this
Agreement shall be made by wire transfer, unless otherwise
specified by the receiving party.
7.3.1.2 Late Payments. In the event that any payment,
including royalty, milestone and research payments, due
hereunder is not made when due, the payment shall accrue
interest from
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* ; provided that in no event shall such rate exceed the
maximum legal annual interest rate. The payment of such
interest shall not limit any party from exercising any other
rights it may have as a consequence of the lateness of any
payment.
7.3.2 Records and Audit. During the term of this Agreement and
for a period of two years thereafter, the parties shall each keep
complete and accurate records pertaining to the development of Products
and sale or other disposition of Products in sufficient detail to
permit the other party to confirm the accuracy of all payments and cost
reimbursements due hereunder. Each party shall have the right to have a
representative (including an independent, certified public accountant
if so designated by a party) to audit such books and records to confirm
(i) in the case of APOTHECON, its books and records pertaining to Gross
Sales, Net Sales and royalty and other payments due for the then
current year and the two preceding years, and (ii) in the case of GJT,
its books and records pertaining to any costs or other charges for
which it seeks payment or reimbursement hereunder. Such audits may be
exercised during normal business hours not more frequently than once a
year upon notice to such other party. The party requesting the audit
shall bear the full cost of such audit unless such audit discloses a
variance of * due under this Agreement. In such case, the audited party
shall bear the full cost of such audit. The terms of this Section shall
survive any termination or expiration of this Agreement for a period of
*.
7.3.3 Taxes. All turnover, income and other taxes levied on
account of the royalties and other payments accruing to each party
under this Agreement shall be paid by the party receiving such royalty
or other payment for its own account, including taxes levied thereon as
income to the receiving party.
7.4 Exchange Control. If at any time legal restrictions prevent the
prompt remittance of part or all royalties, purchase price for Product, or other
payments due hereunder, APOTHECON shall have the right, in its sole discretion,
to make such payments by depositing the amount thereof in local currency to
GJT's account in a bank or other depository institution in such country imposing
such restrictions.
7.5 Withholding Taxes. If provision is made in law or regulation for
withholding of taxes of any type, levies or other charges with respect to any
royalty or other amounts payable under this Agreement to any party or other
Person, the party making such payment shall be entitled to deduct such tax, levy
or charge from the royalty or other payment to be made by the party making same
and pay such tax, levy or charge to the proper taxing authority. A receipt of
payment of the tax, levy or charge secured shall be promptly delivered to the
party entitled to the royalty or other payment, together with copies of all
pertinent communications from or with such governmental authorities with respect
thereto. Each party agrees to assist the other party in claiming exemption from
such deductions or withholdings under any double taxation or similar agreement
or treaty from time to time in force and in minimizing the amount required to be
so withheld or deducted.
ARTICLE 8
PATENT RIGHTS
[Intentionally omitted]
ARTICLE 9
TRADEMARKS
9.1 GEOMATRIX Trademark. The GEOMATRIX trademark, as licensed to GJT by
Jagotec as of the date hereof, shall remain the sole and exclusive property of
GJT or Jagotec, as the case may be. APOTHECON shall not, directly or indirectly
through its officers, directors, employees, agents, Affiliates, customers or
other Persons, acquire any proprietary interest or other right to such GEOMATRIX
trademark, other than as provided in the Agreement. Notwithstanding the
foregoing, GJT grants to APOTHECON a non-exclusive, royalty-free
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- 11 -
license (including the right to grant sublicenses in the same manner as provided
herein for the GEOMATRIX patent rights) to use such GEOMATRIX trademark in
connection with, and for the development, use and sale of, the Products under
the Agreement. GJT shall control, at its sole expense, the prosecution of any
litigation or other action to xxxxx the unauthorized use of such GEOMATRIX
trademark, and the defense of any claim in any litigation or other action
alleging that the use of such GEOMATRIX trademark infringes the rights of any
Third Party. A list of such GEOMATRIX Trademarks for the Territory covered by
this Agreement are set forth on Exhibit 9.1 hereto.
9.2 Registration of Other Trademarks. APOTHECON shall have the right,
in its sole discretion and expense, to register and maintain other trademarks of
its choice to be used in connection with the Products. Such other trademarks
shall be held in the name of APOTHECON.
9.3 Use of GEOMATRIX Trademark. APOTHECON shall be entitled to use, as
it considers appropriate in the exercise of its sole and absolute discretion and
without being obligated in any way, expressly or impliedly to do so, the
GEOMATRIX trademark on the label for the Product. APOTHECON agrees to use the
GEOMATRIX trademark in an appropriate manner in print advertising for the
Product and in the package insert for the Product, it being understood that the
APOTHECON name and marks and the Xxxxxxx-Xxxxx Squibb names and marks shall have
preeminence. APOTHECON may also use such other trademarks as it deems
appropriate in connection with the development, use, distribution, marketing and
sale of the Products. Except as otherwise set forth in the Agreement or as
otherwise agreed to in writing by GJT, APOTHECON shall not use such GEOMATRIX
trademark and such other trademarks in any manner whatsoever which infringe the
trademarks or other rights owned by GJT or its Affiliates.
ARTICLE 10
CONFIDENTIALITY
[Intentionally omitted]
ARTICLE 11
TERM AND TERMINATION
11.1 Term. This Agreement shall commence effective upon the Effective
Date. The Agreement shall continue until terminated upon the earlier to occur of
the following: (i) pursuant to Section 11.2 below, (ii) by mutual written
agreement, or (iii) on a country-by-country basis in the Territory upon the
expiration of the Royalty Term in such country.
Upon termination of this Agreement, in whole or in part, pursuant to
section 11.1(ii), the parties will determine the disposition of rights hereunder
as part of such mutual termination. Upon expiration of this Agreement as to any
country in the Territory under Section 11.1(iii) above, APOTHECON shall have an
irrevocable, perpetual, fully paid-up and royalty-free, non-exclusive right and
license to use the Know-how in order to develop, make, have made, use and sell
Products in such country.
11.2 Termination. This Agreement may be terminated in accordance with
any of the following (all of which may be exercised independently of the other):
11.2.1 Termination Without Cause. APOTHECON may elect at any
time, for any reason and without cause, to terminate this Agreement, in
whole or in part as to one or more countries, upon sixty (60) days
written notice to GJT:
11.2.1.1 If * elects to so terminate under this
section 11.2.1 prior to filing of the ANDA in the United
States, then: (i) such termination shall be *
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to *; (ii) all rights and licenses granted by GJT hereunder
shall * with respect to such country(ies) so terminated,
provided, further, that if * so elects to terminate under this
section 11.2.1 in the United States, it shall be deemed a
termination as to the *; (iii) * of any * that are scheduled
or may be made in the future under sections 4.6 of the *
Development and Marketing Agreement and 7.1 hereof (and the
subsections thereunder), provided that such termination is
exercised with respect to the United States; (iv) all
Registrations pertaining to the marketing of the Product shall
be * as to the affected country(ies) and the * under the *
Development and Marketing Agreement shall be provided to and
thereafter may be * to develop, manufacture and market the
Product; (v) the * Development and Marketing Agreement shall *
with respect to the development and marketing of the Product
in such country(ies); and (vi) * and its Affiliates shall
thereafter be entitled to exercise such rights as they may
have under the GEOMATRIX Agreements to make, have made, use or
sell the Product in the country(ies) so terminated without
compensation or obligation to *; 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 * or its Affiliates.
11.2.1.2 If * elects to so terminate this Agreement under this
section 11.2.1 subsequent to the * in the United States, then:
(i) such termination shall be to *; (ii) all rights and
licenses granted by * hereunder shall * with respect to such
country(ies) so terminated; (iii) * shall be relieved of any
payments that are scheduled or may be made in the future under
section 7.1 hereof and section 4.6 of the * Development and
Marketing Agreement (and the subsections thereunder), provided
that such termination is exercised with respect to the United
States; (iv) * 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 * or its Affiliates); (v) the * Development and
Marketing Agreement shall terminate with respect to the
development and marketing of the Product in such country(ies);
(vi) all Registrations pertaining to the Product shall be * as
to the affected country(ies) and the * under the * Development
and Marketing Agreement shall be provided to and thereafter
may be * to develop, manufacture and market the Product; and
(vii) * shall pay to * the same *, which shall be paid in the
same manner and subject to the same terms and conditions as
would otherwise have applied to *, as * would otherwise have
paid (absent such termination) hereunder to * (or on the * of
such *, as the case may be) of the Product in the country(ies)
to which such termination applies (with such * to be paid by
GJT and its Affiliates in each such country until expiration
of the Royalty Term in each such country), until such time as
the * paid to * equal the aggregate amount that had been paid
by * to * prior to such termination under the aforesaid
sections 4.6 and 7.1 (and the subsections thereunder), at
which time the *.
11.2.2 Termination for Default. Except as otherwise provided
in Article 13 below, upon or after the breach of any material
provision of the Agreement by a party (unless such failure
results from, or is caused by, adherence required by a party
to applicable laws or governmental regulations), if the
breaching party has not cured such breach within sixty (60)
days after notice thereof by the other party, the nonbreaching
party may terminate this Agreement; provided, however, if any
default is not capable of being cured within such 60-day
period and the breaching party has diligently undertaken to
cure such default within such 60-day period and continues to
take diligent steps to cure same as soon as commercially
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feasible thereafter under the circumstances, the nonbreaching party
shall have no right to terminate the Agreement.
In cases where the breach involves an act or omission by a party
specifically and directly relating to a country or countries,
termination shall be limited to the country or countries affected by
such breach, as opposed to termination of the entire Agreement, and the
remedies listed in section 11.2.2.1-11.2.2.4 below shall be limited to
such country or countries.
11.2.2.1 If GJT breaches this Agreement prior to the date that
initial commercial launch occurs in the United States and in a
manner that entitles * to terminate this Agreement pursuant to
this section 11.2.2, then, if * elects to terminate this
Agreement: (i) all rights and licenses granted to * under this
Agreement shall revert to GJT; (ii) no further payments shall
be due from * with respect to any of the milestones not yet
paid that are set forth in Section 4.6 of the * Development
and Marketing Agreement and section 7.1 hereof (and the
subsections thereunder); (iii) the * Development and Marketing
Agreement shall terminate with respect to the development and
marketing of the Product in such country(ies); (iv) all
Registrations pertaining to the Product shall be * as to the
affected country(ies) and the * under the * Development and
Marketing Agreement shall be provided to and thereafter may be
* to develop, manufacture and market the Product (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 * or its Affiliates); (v) *
shall pay to * the same *, which shall be paid in the same
manner and subject to the same terms and conditions as would
otherwise have applied to *, as * would otherwise have paid
(absent such termination) hereunder to * (or on the * of such
*, as the case may be) of the Product in the country(ies) to
which such termination applies (with such * to be paid by *
and its Affiliates until expiration of the Royalty Term in
each such country), until such time as the * paid to * equal
the aggregate amount that had been paid by * to GJT prior to
such termination under said sections 4.6 and 7.1 (and the
subsections thereunder), at which time the * from time to time
thereafter; and (vi) such termination shall be without
prejudice to any other rights or remedies available to *
arising from such breach.
11.2.2.2 If GJT breaches this Agreement subsequent to
the date that initial commercial launch occurs in the United
States and in a manner that entitles APOTHECON to terminate
this Agreement pursuant to this section 11.2.2, then, if
APOTHECON elects to terminate this Agreement, then the
provisions of subsections 11.2.2.1 (i)-(vi) apply as though
fully set forth herein.
11.2.2.3 If APOTHECON breaches this Agreement prior
to the date that initial commercial launch occurs in the
United States and in manner that entitles GJT to terminate
this Agreement pursuant to this section 11.2.2, then GJT may
elect either:
(A) to pursue all claims and causes of
action available to it at law or in equity
for such breach, or
(B) to terminate this Agreement, in which
event: (i) * shall be deemed to waive and
release all claims and causes of action
available to it at law or in equity for such
breach, and such termination shall be
without penalty or liability to *; (ii) all
rights granted by * hereunder (including
without limitation under Articles 3 and 9
hereof) shall * with respect to such
country(ies) so terminated; (iii) *
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will be relieved of any * that are scheduled
or may be made in the future under section
4.6 of the * Development and Marketing
Agreement and section 7.1 hereof (and the
subsections thereunder); (iv) all
Registrations pertaining to the marketing of
the Product shall be as to the affected
country(ies) and the * under the *
Development and Marketing Agreement shall be
provided to and thereafter may be * * to
develop, manufacture and market the Product;
(v) the * Development and Marketing
Agreement shall terminate with respect to
the development and marketing of the Product
in such country(ies); and (vi) * and its
Affiliates shall thereafter be entitled to *
as they may have under the GEOMATRIX
Agreements to make, have made, use or sell
the Product in the country(ies) so
terminated without compensation or
obligation to *; 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, or other
intellectual property rights owned or
controlled by * or its Affiliates.
11.2.2.4 If APOTHECON breaches this Agreement
subsequent to the date that initial commercial launch occurs
in the United States and in manner that entitles GJT to
terminate this Agreement pursuant to this section 11.2.2, then
GJT may elect either:
(A) to pursue all claims and causes of
action available to it at law or in equity
for such breach, or
(B) to terminate this Agreement, in which
event: (i) * shall be deemed to waive and
release all claims and causes of action
available to it at law or in equity for such
breach, and such termination shall be
without penalty or liability to *; (ii) all
rights and licenses granted by GJT hereunder
shall * with respect to such country(ies) so
terminated; (iii) * shall be relieved of any
* that are scheduled or may be made in the
future under section 7.1 hereof and section
4.6 of the * Development and Marketing
Agreement (and the subsections thereunder),
provided that such termination is exercised
with respect to the United States; (iv) *
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 * or its Affiliates); (v) the
* Development and Marketing Agreement shall
terminate with respect to the development
and marketing of the Product in such
country(ies); (vi) all Registrations
pertaining to the Product shall be * as to
the affected country(ies) and the * under
the * Development and Marketing Agreement
shall be provided to and thereafter may be *
to develop, manufacture and market the
Product; and (vii) * shall pay to * the same
*, which shall be paid in the same manner
and subject to the same terms and conditions
as would otherwise have applied to *, as *
would otherwise have paid (absent such
termination) hereunder to * (or on the * of
such *, as the case may be) of the Product
in the country(ies) to which such
termination applies (with such * to be paid
by * and its Affiliates in each such country
until expiration of the Royalty Term in each
such country), until such time as the * paid
to
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* equal the aggregate amount that had been
paid by * to * prior to such termination
under the aforesaid sections 4.6 and 7.1
(and the subsections thereunder), at which
time the *.
11.2.3 Termination for Failure to Meet Milestones.
11.2.3.1 If all bioequivalence testing, all pivotal
clinical and bioequivalence studies shall not have been
completed, and Validated Manufacturing Scale-Up capabilities
(bio-batches) for the Product shall not have been completed
and demonstrated to APOTHECON's reasonable satisfaction, * so
as to enable manufacture and marketing of the Product in the
United States and other major markets designated by APOTHECON,
and APOTHECON is not otherwise entitled to terminate this
Agreement pursuant to any other provision of this Article 11:
a) APOTHECON will have the right to
immediately terminate this Agreement at any
time thereafter until *, or
b) allow additional time for the completion
and demonstration of same until *.
If APOTHECON elects to terminate this Agreement with respect
to one or more countries pursuant to option (a) above, then
the provisions of section 11.2.1.2(i)-(vii), inclusive, shall
apply.
If APOTHECON elects not to terminate this Agreement in
accordance with (a) above, then all payments due after under
section 7.1 hereof shall be * shall not apply if (A) the
failure to so demonstrate and complete the foregoing was due
to * failure to use all reasonable efforts to Scale-up and to
manufacture adequate quantities of conforming Product on a
timely basis (and * shall have given reasonable advance notice
of its requirements) and/or failure to comply in all material
respects with the Specifications and written instructions
provided * with respect to the use of the GEOMATRIX Technology
in connection with the manufacture of the Product, and (B) *
shall have fulfilled its obligations hereunder in all material
respects with respect to the transfer and training in the use
of the GEOMATRIX Technology.
11.2.3.2 If, notwithstanding APOTHECON's election
under section 11.2.3.1(b) above, all bioequivalence testing,
all pivotal clinical and bioequivalence studies shall not have
been completed, and Validated Manufacturing Scale-Up
capabilities (bio-batches) for the Product shall not have been
completed and demonstrated to APOTHECON's reasonable
satisfaction, by * so as to enable manufacture and marketing
of the Product in the United States and other major markets
designated by APOTHECON, and APOTHECON is not otherwise
entitled to terminate this Agreement pursuant to any other
provision of this Article 11, then APOTHECON shall be entitled
to elect, at any time within thereafter, to terminate this
Agreement, in which event the provisions of section
11.2.1.2(i)-(vii), inclusive, shall apply.
If APOTHECON elects not to terminate this Agreement in
accordance with this section 11.2.3.2, then * shall not apply
if (A) the failure to so demonstrate and complete the
foregoing was due to * failure to use all reasonable efforts
to Scale-up and to manufacture adequate quantities of
conforming Product on a timely basis (and * shall have given
reasonable advance notice of its requirements) and/or
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failure to comply in all material respects with the
Specifications and written instructions provided * with
respect to the use of the GEOMATRIX Technology in connection
with the manufacture of the Product, and (B) * shall have
fulfilled its obligations hereunder in all material respects
with respect to the transfer and training in the use of the
GEOMATRIX Technology.
11.2.4 Other Termination.
11.2.4.1 Termination for Misrepresentation. In the
event that a representation or warranty of GJT hereunder is
untrue in any material respect, APOTHECON shall be entitled to
terminate this Agreement upon thirty (30) days' written notice
to GJT. If APOTHECON elects to so terminate, the rights and
actions indicated in sections 11.2.2.1 (i)-(vi), inclusive,
shall apply as though set forth herein.
11.2.4.2 Termination for Failure to Repay Working
Capital Agreement. If GJT fails to make a payment when due
under its Restated Working Capital Agreement dated as of May
12, 1995 (as amended by a First Amendment thereto dated as of
July 11, 1995, and as the same may be amended from time to
time hereafter, and including any successor agreement thereto)
between GJT and Genta, Incorporated, a Delaware corporation
("Genta"), GJT shall promptly inform APOTHECON of same, and
APOTHECON may elect (by delivering a writing to GJT, Jagotec
and Jago Pharma of APOTHECON's intent to exercise such option)
at any time thereafter to terminate this Agreement and to
require each of Jagotec and Jago Pharma to, and Jagotec and
Jago Pharma agree that each of them will, promptly enter into
a new, separate agreement with APOTHECON under which (i) Jago
Pharma and Jagotec will, to the extent each has the right to
do so, ensure that all licenses, sublicenses and other rights
and privileges granted by GJT under this Agreement shall
continue without change, (ii) Jago Pharma will assume all
rights and obligations of GJT under articles 3, 4, 5, 6,
11.4.5, 12, 14, 15. 1, and 15.2 of the * Development and
Marketing Agreement and will promptly cure any defaults of GJT
under said articles, any payments to be made thereafter by
APOTHECON under said articles shall thereafter be paid to Jago
Pharma, and APOTHECON shall continue to enjoy all rights and
privileges granted under said articles, and (iii) Jagotec will
assume all rights and obligations of GJT under article 8 of
the * Development and Marketing Agreement and under articles
3.1, 6, 7 and 9 hereof, any payments to be made thereafter by
APOTHECON under said articles shall thereafter be paid to
Jagotec, and APOTHECON shall continue to enjoy all rights and
privileges granted under said articles; provided, however,
that such new agreement with Jagotec shall provide that all
payments that would otherwise have been made thereafter by
APOTHECON under article 7 hereof shall continue thereafter to
be paid to GJT by APOTHECON, until APOTHECON is duly
instructed otherwise in writing by GJT and Jagotec.
11.2.5 No Effect on Remedies. Where APOTHECON elects not to
terminate the Agreement pursuant to section 11.2.2.1, 11.2.2.2, or
11.2.4, such decision shall be without prejudice to any other rights or
remedies available to APOTHECON arising from such breach or untrue
statement.
11.2.6 Injunctive Relief. If:
i) GJT or its Affiliates breach section 3.1
hereof or section 6.3 of the * Development
and Marketing Agreement, or
ii) APOTHECON or its Affiliates breach section
3.1 hereof,
then the parties acknowledge and agree that such breach will cause
irreparable injury to the nonbreaching party or its Affiliates, for
which monetary damages, even if available, will be inadequate and
difficult, if not impossible, to accurately ascertain. Accordingly, the
parties agree that the nonbreaching party or its Affiliates may seek
and obtain injunctive relief against the breach or threatened breach of
the undertakings
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set forth in this section 11.2.6(i) and (ii), in addition to any other
rights or remedies which may be available to the nonbreaching party or
to its Affiliates at law or in equity.
11.2.7 Effect on Continuing Business. In the event of a
termination of this Agreement in which the rights to market the Product
revert to GJT hereunder, GJT shall not be under any obligation, express
or implied, to use the Registrations and data transferred to it or to
continue to commercialize the Product, and APOTHECON shall not be under
any obligation, express or implied, to continue to transfer any
inventory of Product to GJT or to manufacture Product for GJT following
such termination.
11.3 Effect of Bankruptcy. If a party becomes insolvent or admits in
writing its inability to pay its debts as they mature or applies for or consents
to the appointment of a receiver or trustee for any of its properties; or a
receiver or trustee is appointed for such party or a substantial portion of its
properties and is not discharged within ninety (90) days; or any bankruptcy,
reorganization, debt arrangement, dissolution, liquidation or other proceeding
under any bankruptcy or insolvency law is instituted by or against such party
and, if instituted against such party, it is consented to by such party or
remains undismissed for ninety (90) days, then
11.3.1 Notwithstanding any such event, such party shall remain
obligated to fulfill its obligations and covenants hereunder, and any
failure to do so or other breach hereunder shall entitle the other
party to terminate this Agreement in accordance with section 11.2
hereof; and
11.3.2 It is the parties' desire that, if any such receiver,
trustee, judge, arbitrator or other adjudicator conducting or
controlling such proceedings on behalf of a party should hold that any
obligations, covenants or duties of such party hereunder should be
suspended or declared unenforceable, in whole or in part, then the
rights and benefits granted to the other party hereunder shall remain
in full force and effect, and that any such obligations, covenants or
duties shall be reformed by such receiver, trustee, judge, arbitrator
or other adjudicator so as to be enforceable to the maximum extent
permitted by applicable law and to permit any suspension to be lifted
at the earliest practicable time.
11.4 Other Effects.
11.4.1 Effect of Reversion. Where a termination of this
Agreement, as provided for in this Article 11.2, results in a reversion
of rights to GJT that had been granted to APOTHECON under Articles 3
and 9 hereof, APOTHECON shall not thereafter make any use of the Patent
Rights and Trademarks, and, except to the extent the same shall have
entered the public domain, the Know-how, with respect to the
country(ies) affected by such termination.
11.4.2 Survival. The provisions of
(i) Articles 2.2 and 9 shall survive any
expiration of this Agreement under section
11.1 (iii), and
(ii) Articles 7.3-7.5, 11.2.4.1, 11.2.5, 11.2.7,
11.4-11.6, 16.2, 16.3 and 16.4 shall survive
any expiration or termination of the
Agreement, in whole or in part,
as well as such other terms, obligations and rights which, by their
intent or meaning, are intended to so survive. The expiration or
termination of the Agreement shall not relieve either party of payment
of any amounts that may be owed to the other based upon events
occurring or rights accruing prior to the date of termination, and
shall be without prejudice, except as provided in sections 11.2.2.3,
and 11.2.2.4, to any rights and obligations of either party accruing
prior to, or that may be based on acts or omissions of the other party
occurring prior to, the effective date of termination.
11.4.3 Undeveloped Products. The Products licensed hereunder
shall not be treated as "Undeveloped Products" under sections 11.2.3 of
the GEOMATRIX License Agreement and GEOMATRIX Manufacturing License
Agreement.
- 18 -
11.4.4 No Waiver. The right of either party to terminate this
Agreement, as hereinabove provided, or to pursue rights and remedies
available to it at law or in equity, shall not be affected in any way
by its waiver of, or failure to take action with respect to, any
previous defaults or breaches hereunder.
11.4.5 Use of Data Following Termination. Notwithstanding any
provision of this Agreement that may state or imply to the contrary, in
the event that this Agreement terminates for any reason, it is
understood and agreed that all data generated pursuant to activities
funded by APOTHECON pursuant to section 4.6 of the * Development and
Marketing Agreement and transferred or made available to GJT or its
Affiliates under this Agreement (including without limitation pursuant
to 11.2.1.1(iv), 11.2.1.2(vi), 11.2.2.1(iv), 11.2.2.3(iv), or
11.2.2.4(vi) of this Agreement) may not thereafter be used by, and may
not thereafter be made available to or disclosed to any Third Party by,
GJT or any of its Affiliates (including any Jagotec and Genta
Incorporated, a Delaware corporation, and their respective Affiliates)
in the development, or registration or filing for regulatory approval,
of any product other than the Product (including without limitation not
using and not making such data available for developing or filing of an
NDA in the United States for a * product based on, incorporating, or
derived from the use of, the GEOMATRIX Technology), without the prior
written consent of APOTHECON (which consent may be given or withheld in
its sole and absolute discretion).
11.5 Survival of Rights and Sublicenses.
11.5.1 In the event of an event that the GEOMATRIX License
Agreement and/or the GEOMATRIX Manufacturing License Agreement is or
are terminated, for whatever reason and whether by action taken by
Jagotec, GJT or both, this Agreement, and all licenses, sublicenses and
other rights and privileges granted or extended to APOTHECON hereunder,
shall continue and remain in full force and effect in accordance with
their terms, without further action or election on the part of
APOTHECON, and notwithstanding any provision (including without
limitation section 11.4) to the contrary in the GEOMATRIX License
Agreement and the GEOMATRIX Manufacturing Agreement.
11.5.2 If GJT breaches this Agreement in a manner that
entitles APOTHECON to terminate same pursuant to section 11.2.2.1 or
11.2.2.2, or makes an untrue statement that entitles APOTHECON to
terminate same pursuant to section 11. 2.4.1, or in the event that GJT
commences proceedings to dissolve, liquidate or wind up its affairs,
then, in addition to any other remedies available to it hereunder or at
law or in equity, APOTHECON may (A) elect any remedies available to it
under any applicable Waiver and Consent and/or (B) elect (by delivering
a writing to GJT, Jagotec and Jago Pharma of APOTHECON's intent to
exercise its rights under this section 11.5.2) to terminate this
Agreement with GJT, and: (i) any licenses, sublicenses and other rights
and privileges granted by GJT under this Agreement shall continue
without further action or election on the part of APOTHECON, with
APOTHECON continuing to have the same rights and obligations as are set
forth in this Agreement, notwithstanding any provision to the contrary
contained in section 11.4 of the GEOMATRIX License Agreement (as the
same may be thereafter amended, supplemented or extended) or in section
11.4 of the GEOMATRIX Manufacturing License Agreement (as the same may
be thereafter amended, supplemented or extended), (ii) Jago Pharma and
Jagotec will, to the extent each has the right to do so, ensure that
all licenses, sublicenses and other rights and privileges granted by
GJT under this Agreement shall continue without change, (iii) Jago
Pharma will enter into an agreement with APOTHECON under which Jago
Pharina will assume all rights and obligations of GJT under articles 3,
4, 5, 6, 11.4.5, 12, 14, 15.1, and 15.2 of the * Development and
Marketing Agreement, will promptly cure any defaults of GJT under said
articles, any payments to be made thereafter by APOT'HECON under said
articles shall thereafter be paid to Jago Pharma, and APOTHECON shall
continue to enjoy all rights and privileges granted under said
articles, and (iv) Jagotec will enter into an agreement with APOTHECON
under which Jagotec will assume all rights and obligations of GIT under
article 8 of the * Development and Marketing Agreement and under
articles 3.1, 6, 7 and 9 hereof, any payments to be made thereafter by
APOTHECON under shall thereafter be paid to Jagotec, and APOTHECON
shall continue to enjoy all rights and privileges granted under said
articles. Upon request, Jagotec and Jago Pharma AG will deliver to
APOTHECON satisfactory confirming written documentation of same.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
- 19 -
11.5.3 In no event shall APOTHECON be required, as a condition
to the continuance or continuing validity of any license, sublicense or
other rights granted by GJT under this Agreement, to give written
notice to Jagotec of any election to continue such rights, to assume
all rights and obligations of GJT, and/or to promptly cure all defaults
of GJT, as otherwise required under section 11.4 of each of the
GEOMATRIX License Agreement and GEOMATRIX Manufacturing License
Agreement.
11.6 Transfer of Registrations and Rights. In the event this Agreement
terminates, and GJT is entitled hereunder (and notifies APOTHECON in writing
that it desires) to continue the development and marketing of the Product in the
country(ies) affected by such termination, the parties agree to reasonably
cooperate to ensure an orderly transition for a reasonable period (not to exceed
*) following such termination, and the parties will effectuate an orderly
transfer of any Registrations owned or controlled by APOTHECON with respect to
the Product in such country(ies) to GJT; provided, however, that in no event
shall the foregoing create or imply any right to use or license under any patent
rights, copyright rights, trademarks or trade names (including those for the
Product), know-how, or other intellectual property rights owned or controlled by
APOTHECON or its Affiliates. Such transfer(s) in such country(ies) shall be *;
provided that * shall bear all * into its name in such country(ies) and shall
reimburse for any out-of-pocket costs incurred by it in connection with the
foregoing. * shall be entitled to retain, subject to the * as provided for in
section 7.2, the amount received by it on * during such transition period and
shall use reasonable efforts to comply with the terms of this Agreement. For any
other termination of this Agreement, such termination shall not result in any
transfer of any Registrations owned or controlled by APOTHECON to GJT or
Jagotec, and regardless of any provision (such as sections 11.5 of the GEOMATRIX
License Agreement and of the GEOMATRIX Manufacturing License Agreement) to the
contrary in any agreement between GJT and any one or more of its Affiliates.
ARTICLE 12
INDEMNITY
[Intentionally omitted]
ARTICLE 13
FORCE MAJEURE
Neither party hereto shall be held liable or responsible to the other
party nor be deemed to have defaulted under or breached the Agreement for
failure or delay in fulfilling or performing any term of the Agreement, and the
time required for performance shall be extended by the period occasioned by such
cause, 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, but not failure or delay
caused by subcontractors of a party who breach their obligations hereunder. The
party so affected shall give prompt notice to the other party of such cause, and
shall use its best efforts to minimize the delay in performance and adverse
effects occasioned by such cause.
ARTICLE 14
SUBCONTRACTEES
[Intentionally omitted]
- 20 -
ARTICLE 15
ASSIGNMENT; SEVERABILITY; REPRESENTATIONS AND WARRANTIES
15.1 Assignment. Except to the extent specifically set forth in this
Agreement, this Agreement may not be assigned or nor may the performance of any
duties hereunder be delegated or transferred, nor may any right or obligation
hereunder be assigned or transferred, by either party, without the prior written
consent of the other party (which consent shall not be unreasonably withheld);
provided, however, that either party may, without such consent, assign the right
to receive payments to an Affiliate, and may assign the Agreement and its rights
and obligations hereunder in connection with the transfer or sale of all or
substantially all of its business assets to which this Agreement relates, or in
the event of merger, consolidation, or similar reorganization (or change in
control or similar transaction); and provided, further, that in the case of an
assignment, the assigning party shall remain liable as a continuing guarantor
under any such assignment of all obligations and duties assumed by such
Affiliate, and the other party shall have entered into a separate counterpart
agreement with any such Affiliate. Such counterpart agreement shall be in the
same form as this Agreement, except for necessary changes to reflect the extent
of the assignment, the substitution of the Affiliate's name and the effective
date of the assignment.
15.2 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 the 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 the Agreement with such provisions. In case such provisions cannot
be agreed upon, the invalidity of one or several provisions of the Agreement
shall not affect the validity of the Agreement as a whole, unless the invalid
provisions are of such essential importance to the Agreement that it is to be
reasonably assumed that the parties would not have entered into the Agreement
without the invalid provisions.
15.3 General Representations and Warranties. Each party represents and
warrants to the other the following:
15.3.1 Existence and Power. It (a) is duly organized, validly
existing and in good standing under the laws of the jurisdiction in
which it is organized; (b) has the requisite power and authority and
the legal right to own and operate its property and assets, to lease
the property and assets it operates under lease, and to carry on its
business as it is now being conducted; and (c) is in compliance with
all requirements of applicable law, except to the extent that any
noncompliance would not have a material adverse effect on the
properties, business, financial or other condition of it and would not
materially adversely affect its ability to perform its obligations
under the Agreement.
15.3.2 Authorization and Enforcement of Obligations. It (a)
has the requisite power and authority and the legal right to enter into
the Agreement and to perform its obligations hereunder; and (b) has
taken all necessary action on its part to authorize the execution and
delivery of the Agreement and the performance of its obligations
hereunder. The Agreement has been duly executed and delivered on its
behalf, and constitutes a legal, valid, binding obligation, enforceable
against it in accordance with its terms.
15.3.3 No Consents. All necessary consents, approvals and
authorizations of all governmental authorities and other Persons
required to be obtained by it in connection with the Agreement have
been obtained.
15.3.4 No Conflict. The execution and delivery of the
Agreement on its behalf and the performance of its obligations
hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations, and (b) do not conflict with, or
constitute a default under, any contractual obligation of it.
- 21 -
15.3.5 DISCLAIMER OF WARRANTIES. NOTHING IN THE AGREEMENT
SHALL BE CONSTRUED AS A REPRESENTATION MADE, OR WARRANTY GIVEN, BY GJT
THAT ANY RESEARCH AND DEVELOPMENT PERFORMED BY IT UNDER THIS AGREEMENT
WILL BE SUCCESSFUL, IN WHOLE OR IN PART, OR THAT ANY PRODUCTS WHICH MAY
BE DEVELOPED WILL BE SUCCESSFUL IN THE COMMERCIAL MARKETPLACE.
APOTHECON ACKNOWLEDGES THAT, EXCEPT AS OTHERWISE SET FORTH HEREIN OR AS
MAY BE SET FORTH IN A WRITING SIGNED BY GJT, GJT MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO ANY
PRODUCTS WHICH MAY BE DEVELOPED, INCLUDING WITHOUT LIMITATION, ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
15.4 GJT Representations and Warranties. GJT represents and warrants to
APOTHECON as of the Effective Date the following:
15.4.1 The Patent Rights listed on Exhibit 1.1(ii) and the
Trademarks listed on Exhibit 9.1 list all Patent Rights and GEOMATRIX
Trademarks owned or controlled by GJT in the Territory or to which GJT
has the right to grant the license rights, sublicense rights and other
rights granted hereunder, and which may be useful to the manufacture,
development, use or sale of Product, and such Exhibits specify the
jurisdiction(s) by or in which such right has been issued or registered
or in which an application for such issuance or registration has been
filed, including respective registration or application numbers. To the
best knowledge of the current officers and directors of GJT, the issued
Patent Rights are valid and in full force and effect.
15.4.2 Except as disclosed on Exhibit 1.1(ii), to the best
knowledge of GJT's current officers and directors, (i) the use of such
Know-how and any Patent Rights in the manufacture, use and sale of the
Product does not infringe upon any patent rights, copyrights or other
proprietary rights of any Affiliate of GJT or any non-Affiliated,Third
Party in the Territory; (ii) GJT has no knowledge of any infringement
by any Third Party of any of the Patent Rights in the Territory; and
(iii) GJT and each its Affiliates are not subject to any outstanding
order, judgment or decree of any court or administrative agency, and
each has not entered into any stipulation or agreement, restricting its
use of the Patent Rights in connection with the manufacture,
development, use or sale of Products in the Territory.
15.4.3 There is no action, suit or proceeding pending or, to
the knowledge of its current officers and directors, that has been
threatened in writing by any Third Party against GJT or its Affiliates
which, if adversely determined, would have a material adverse effect
upon the ability of APOTHECON to use the Patent Rights or Know-how in
the manufacture, use and/or sale of any Product in the Territory.
15.4.4 The Know-how and Patent Rights licensed and/or
sublicensed by GJT to APOTHECON pursuant to this Agreement were not
been obtained by GJT or its Affiliates in violation of any contractual
or fiduciary obligation to which GJT or any of its Affiliates, any
predecessor-in-interest or any of its or their employees or contractors
is or was a party or by misappropriation of the trade secrets of any
Third Party, and the manufacture, use or sale by or through GJT,
APOTHECON and their respective Affiliates of any Product using such
Know-how and Patent Rights does not and will not violate any such
contractual or fiduciary obligation owed to any such Third Party or
render APOTHECON liable for the payment of any royalty attributable to
or arising out of any such contractual or fiduciary obligation or any
such misappropriation.
15.4.5 During the term of this Agreement, GJT or its
Affiliates will not disclose to APOTHECON and its Affiliates any
proprietary information, such as trade secrets, which is confidential
to any non-Affiliated Third Party or institution and which GJT is not
entitled to disclose in accordance with the terms of this Agreement.
- 22 -
15.4.6 Except as otherwise provided in this Agreement, the
rights under the Know-how or any Patent Rights that have been or will
be licensed to APOTHECON under this Agreement are not and will not be
licensed to any other party to make, have made, use or sell Products in
the Territory.
15.4.7 There are no licenses under any patent rights, and, to
the best knowledge of the current officers and directors of GJT, under
any other intellectual property or other proprietary rights owned or
controlled by any GJT Affiliate or Third Party which are used by GJT in
connection with the manufacture, development, use or sale of Product in
the Territory, other than those listed on Exhibits 1.1(ii) and 9.1.
ARTICLE 16
MISCELLANEOUS
16.1 Notices. Any consent, notice or report required or permitted to be
given or made under the Agreement by one party to the other party shall be in
English and in writing, delivered personally or by registered mail, return
receipt requested, addressed to the other party at its address indicated below
or to such other address as the addressee shall have last furnished in writing
to the addressor and except as otherwise provided in the Agreement shall be
effective upon receipt by the addressee.
If to GJT: Genta Jago Technologies BV
Swiss Branch
Xxxxxxxxxxxx 00
0000 Xxxxxxxx, Xxxxxxxxxxx
Attention: Executive Management Committee
with copies to: Genta Incorporated
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000, X.X.X.
Attention: Xxxxxx X. Xxxxx, Ph.D.
and: Pillsbury Madison & Sutro
000 Xxxxxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxxxxxxx, XX 00000, X.X.X.
Attention: Xxxxxx X. Xxxxxx, Xx., Esq.
and: Jagotec AG
c/o Jago Pharma AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxx, Xxxxxxxxxxx
Attention: Xx. Xxxxxxx Xxxxxxx
and: Xxxxxxxxxxxx Xxxxx & Xxxxxxxxxxx
Xxxxxxxxxxxxxxxx 0
Xxxxxxxx 0000
XX-0000 Xxxxxx, Xxxxxxxxxxx
Attention: Xx. Xxxxxx X. Xxxxxxxxxxxx
If to
APOTHECON: Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000 XXX
Attention: President
- 23 -
with a copy to: Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000 XXX
Attention: Corporate Legal Counsel
16.2 Applicable Law. The Agreement shall be governed by and construed
in accordance with the laws of Switzerland, without reference to the conflicts
of law principles thereof, and shall not be governed by the United Nations
Convention on Contracts for the International Sale of Goods.
16.3 Arbitration. Any dispute, claim or controversy between the parties
relating to, arising out of or in any way connected with the Agreement or any
term or condition hereof, or the performance by either party of its obligations
hereunder, whether before or after termination of the Agreement, 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 the other party. 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 between the parties the cost 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 16.3, shall be determined by
binding arbitration pursuant to this Section 16.3.
16.4 Excise Taxes. If the recipient of any payment hereunder, received
in consideration for providing any goods or services or granting any rights
hereunder, shall have the obligation under any applicable law, regulations or
governance to add, include or pay to the applicable governmental authority, any
value added taxes, turn-over taxes, excise taxes, sales taxes or similar taxes
or levies (collectively, "Excise Taxes') on the amount of such payment received
hereunder, then the recipient shall be entitled to receive the amount of any
Excise Taxes on the amount of such payment hereunder as evidenced by an invoice
from the recipient to the payor of such payment hereunder. The payor of such
payment hereunder shall pay the amount of any such Excise Taxes thereon prior to
the date on which the recipient is required to pay or account for such Excise
Taxes to the applicable governmental authority. The recipient of any such
payment hereunder shall use reasonable efforts to minimize any Excise Taxes on
any such payments hereunder, and promptly shall take all such actions and
execute all such instruments as the payor of such payment hereunder reasonably
requests to enable the payor to apply for and, if possible, to receive prompt
refund or credit of the amount of such Excise Taxes on such payments hereunder.
16.5 Headings. The titles and headings used in the Agreement are
intended for convenience only and shall not in any way affect the meaning or
construction of any provision of the Agreement. A reference to an Article (or
section) shall be deemed to include reference to all sections and subsections
thereunder.
No terms and conditions contained in any purchase order,
acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form
issued by either party shall be effective to the extent they are inconsistent
with or modify the terms and conditions contained herein. Each purchase order
shall contain the requested delivery date(s), quantity purchased, routing
instructions and destination.
16.6 Independent Contractors. It is expressly agreed that the parties
shall be independent contractors and that the relationship between the two
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 consent of the other party to do so.
16.7 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.
- 24 -
16.8 Amendments. The provisions of the 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 the Agreement.
16.9 Entire Agreement. The terms, covenants, conditions and provisions
contained in the Agreement, including the exhibits hereto and any other
agreement (including the * Development and Marketing Agreement) to the extent
herein referenced, together with all of the documents referred to herein as
having been provided by one party to another (pertaining in part to the
Territory in which APOTHECON may exercise its manufacturing rights hereunder),
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.
16.10 Counterparts. The 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.
16.11 Publicity. Neither party to this Agreement shall employ or use
the name of the other party or any Affiliate of such party in any publication or
promotional materials or in any form for public distribution, except as required
by law, without prior written consent of said other party in each instance
(which consent shall not be unreasonably withheld).
IN WITNESS WHEREOF, the parties hereto have duly executed the Agreement
as of the date first set forth above.
APOTHECON, INC.
By: /s/Xxx Xxxx
----------------------------------
Title: Vice President/General Manager
GENTA JAGO TECHNOLOGIES BV
By: /s/ Xxxxxx X. Xxxxx
----------------------------------
Xxxxxx X. Xxxxx, Ph.D.
Managing Director
By: /s/ Xxxxxxx Xxxxxxx
----------------------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
JAGOTEC AG hereby agrees to be bound by the provisions of sections 2.2, 6.3,
8.3, 8.4, 8.5, 11.2.4.2, 11.4.3, 11.4.5, and 11.5 and article 16 of the *
Development and Marketing Agreement and sections 11.2.4.2 and 11.5 of the above
Agreement, that all notices to be given to it shall be given to such address as
is set forth in section 16.1 hereof unless and until it otherwise instructs
APOTHECON in writing.
JAGOTEC AG
By: /s/ Xxxxxxx Xxxxxxx
---------------------
Xx. Xxxxxxx Xxxxxxx
President
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
- 25 -
JAGO PHARMA AG hereby agrees to be bound by the provisions of sections 2.2, 6.3,
11.2.4.2, 11.4.3, 11.4.5, and 11.5 and article 16 of the * Development and
Marketing Agreement and sections 11.2.4.2 and 11.5 of the above Agreement,
agrees that all notices to be given to it shall be given to such address as is
set forth in section 16.1 hereof unless and until it otherwise instructs
APOTHECON in writing:
JAGO PHARMA AG
By: /s/ Xxxxxxx Xxxxxxx
---------------------
Xx. Xxxxxxx Xxxxxxx
President
- 26 -
EXHIBITS
Exhibit 1. l(ii) - List of Patent Rights
Exhibit 3.6(i)-(iv) - Waiver and Consent Agreements
Exhibit 9.1 - List of GEOMATRIX Trademarks
- 27 -
EXHIBIT 1.1(ii)
PATENT RIGHTS
--------------------------------------------------------------------------------
PACO. 1
Subject: System for the controlled-rate release of active substances
Inventors: Colombo, Xx Xxxxx, Xxxxx
Assignee: JAGOTEC AG
Priority: Italy, No. 23321 A/85, Dec 20th 1985
Approved: January 7th 1988, No. 1188212
Valid Until: December 19th 2005
Countries: USA
Approved: June 13th 1989, No. 4.839.177
Valid Until: June 12th 2006
Europe
Approved: November 22nd 1990, No. 0226884
Valid Until: December lst 0000
Xxxxxxxxx
Approved: July 10th 1990, No. 594992
Valid Until: December 18th 2006
Canada
Approved: April 7th 1992, No. 1.298.479
Valid Until: April 6th 2009
New Zealand
Approved: December llth 1990 No. 218.596
Valid Until: December 10th 0000
Xxxxx
Pending
*
PACO. 6
Subject: Tablets with controlled-rate release of active substances
Inventors: Xxxxx, Xx Xxxxx, Colombo
Assignee: JAGOTEC AG
Priority: Italy, No. 2269489, December 14th 1989
Approved, No. 1237904, June 18th 1993
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-1-
PACO. 6 (cont.)
Countries: USA
Approved: June 6th 1995, No. 5,422,123
Valid Until: June 5th 2012
Europe
Pending
*
Canada
Pending
*
Japan
Pending
*
PACO. 7
Subject: Process for preparing pharmaceutical compositions having an
increased active substance dissolution rate, and the compositions
obtained
Inventors: Xxxxx, Xx Xxxxx, Xxxxxxxxx
Assignee: JAGOTEC AG
Priority: Italy, No. 21091, July 27th 1990
Approved: November 16th 1994, No. 1.246.188
Valid Until: July 26th 2010
Countries: USA
lst Application No. 07/733457, Filed July 22nd 1991
Pending: Continuation No. 08/524.739, Filed October 11th 1994
Continuation No. 08/321,123, Filed October 11th 1994
Approved: December 19th 1995, No. 5.476.654
Valid Until: October 10th 2014
Europe
Pending
*
Canada
Pending
*
Japan
Pending
*
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
PACO. 8
Subject: Pharmaceutical tablets releasing the active substance after a
definite period of time
Inventors: Xxxxx, Xx Xxxxx, Xxxxx
Assignee: JAGOTEC AG
Priority: Italy, MI 92 A 001174, Filed May 15th 1992
Countries: USA
Approved: November 7th 1995, No. 5,464,633
Valid Until: May 23rd 2014
Canada
Pending
*
PACO. 9
Subject: Pharmaceutical tablet capable of liberating one or more drugs at
different release rates
Inventors: Xxxxx, Xx Xxxxx, Xxxxx
Assignee: JAGOTEC AG
Priority: Italy, MI 92 A 002192, Filed September 24th 1992
Countries: PCT Application, No. PCT/EP93/02556,
Filed September 21st 1993
Designated Territories: Australia
Canada
Japan
USA
New Zealand
European Patent Territory
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
EXHIBIT 3.6(I)
GENTA JAGO DELAWARE, L.L.C.
XXX XXXXX, XX 00000 XXX
February 28, 1996
Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx
XXX
ATTN: President
Genta Jago Technologies B.V., Swiss Branch
Xxxxxxxxxxxx 00
0000 Xxxxxxxx
XXXXXXXXXXX
ATTN: Executive Management Committee
Jago Pharma AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxx
XXXXXXXXXXX
ATTN: President
Genta Incorporated
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000
XXX
ATTN: President
Re: WAIVER AND CONSENT
Gentlemen:
Reference is hereby made to:
i) An Agreement dated the date hereof by and between Apothecon, Inc.
a Delaware corporation, and Genta Jago Technologies BV ("GJT"), a
Dutch company, regarding the development of * , using certain
proprietary sustained release technology licensed to GJT by
Jagotec AG (said agreement, as it may be supplemented, changed or
extended from time to time hereafter, is referred to as the "*
Development Agreement"). Each of you acknowledges receipt of a
copy of said agreement; and
ii) An Agreement dated the date hereof by and between Apothecon and
Genta Jago Technologies BV ("GJT"), a Dutch company, regarding the
grant of certain license rights to Apothecon to make, have made,
use and sell * under certain Patent Rights and Know- How licensed
to GJT pertaining to certain proprietary sustained release
technology licensed to GJT by Jagotec AG (said agreement, as it
may be supplemented, changed or extended from time to time
hereafter, is referred to as
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
the "* License Agreement"). Each of you acknowledges receipt of a
copy of said agreement. The * License Agreement and the *
Development Agreement are referred to herein as the "*
Agreements."; and
iii) The Restated GEOMATRIX Research and Development Agreement dated as
of May 12, 1995 by and among GJT, Jago Pharma AG, as Swiss
corporation, Genta Incorporated ("Genta"), a Delaware corporation,
and Genta Jago Delaware, L.L.C. ("Genta Jago LLC), a Delaware
limited liability company (the "GEOMATRIX Research and Development
Agreement".
All capitalized terms not expressly defined in this Waiver and Consent
agreement ("the "Genta Jago LLC Waiver and Consent Agreement") have the meaning
ascribed to such term in the * License Agreement.
Jagotec AG and Genta are each 50% owners of the equity and income
interests of GJT. Jagotec and Jago Pharma AG are Affiliates of one another, of
GJT, and of Jago Holding AG, a Swiss corporation. Genta and GPM Generic
Pharmaceuticals Manufacturing, Inc. (the latter entity being an Affiliate
Jagotec AG) are each a 50% owner of the equity and income interests of Genta
Jago LLC. Genta Jago LLC acknowledges, and each of the parties signing below
hereby acknowledges, that it expects to derive, directly or indirectly,
substantial economic benefit as a result of the execution, delivery and
performance of the * License Agreement, the * Development Agreement, and of the
GEOMATRIX Agreements. Therefore, in order to induce Apothecon to execute,
deliver and perform the * Agreements, to make the payments required of Apothecon
thereunder, and to accept GJT's promises to discharge its obligations thereunder
and otherwise, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged by each party signing below, Genta
Jago Delaware L.L.C. hereby represents, warrants, agrees, and covenants to and
with Apothecon, and each other party signing below hereby represents, warrants,
agrees and concurs, as follows:
1. Notwithstanding any provision in the GEOMATRIX Research and Development
Agreement to the contrary:
a. All applications filed by Genta Jago LLC pursuant to its obligations
under the GEOMATRIX Research and Development Agreement as are necessary
or useful for the Registration of the Product shall be filed in the name
of, and be owned by, Apothecon, and not GJT.
b. All data and results pertaining to the Product generated by Genta Jago
LLC under the Research and Development Agreement shall be owned solely by
Apothecon. Concurrently with the execution and delivery of this Genta
Jago LLC Waiver and Consent Agreement, Genta Jago LLC will turn over to
Apothecon all data and results heretofore developed by or for it
pertaining to the Product. Genta Jago LLC will thereafter report in
writing such data and results developed by or for it not less frequently
than quarterly to Apothecon and GJT (and monthly if requested by either
party), and will immediately transmit all such data to Apothecon by
magnetic media or such other method as Apothecon shall request.
c. In the event that the GEOMATRIX Research and Development Agreement
should terminate, for whatever reason and however effected, and/or in the
event that GJT commences proceedings to dissolve, liquidate or wind up
its affairs, then, in addition to any remedies available to APOTHECON
under the * Development and Marketing Agreement at law or in equity,
Genta Jago LLC shall, at Apothecon's request, enter into an agreement
with Apothecon for the development and registration of the Product on
terms and conditions that, to the maximum practicable extent, require
Genta Jago LLC to perform the same obligations and observe the same terms
and conditions as apply to it under the GEOMATRIX Research and
Development Agreement (without regard to Genta and Jago Pharma's duties
or responsibilities thereunder), and with Apothecon having the rights
that GJT otherwise had under such GEOMATRIX Research and Development
Agreement and with APOTHECON assuming GJT's obligations under such
GEOMATRIX Research and Development Agreement to the extent such
obligations do not conflict with or are in addition to the obligations
that Apothecon has under the * Development and Marketing Agreement. In
such event Apothecon shall be entitled to grant to Genta Jago LLC a under
the Patent Rights and Knowhow solely to conduct the Research and
Development (as such term is defined in the GEOMATRIX
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
Research and Development Agreement) that Genta Jago LLC is obligated to
conduct under the GEOMATRIX Research and Development Agreement, and any
payments for services performed thereafter by Genta Jago LLC with respect
to the development of the Product shall be made directly by APOTHECON to
Genta Jago LLC.
2. Genta Jago LLC shall submit to Apothecon, concurrently with its
submission to GJT, a copy of (i) all reports, statements, invoices, Product
Workplans, and budgets submitted by Genta Jago LLC to GJT or to the Steering
Committee relating to the Product, (ii) a copy of all reports relating to the
Product submitted to GJT under section 5.4 of the GEOMATRIX Research and
Development Agreement, and (iii) a copy of all submissions to, and all responses
and approvals obtained from, a regulatory authority relating to the Product.
Genta Jago LLC shall promptly inform Apothecon of any default by GJT under the
GEOMATRIX Research and Development Agreement. Following any such default,
Apothecon shall have the right, but shall not be under any obligation of any
nature whatsoever, expressly or impliedly, to (i) cure any such default, and/or
(ii) pay Genta Jago LLC directly thereafter for all services performed by it
under the GEOMATRIX Research and Development Agreement that pertain to the
Product and deduct and offset same from any monies payable thereafter by
Apothecon to GJT.
3. Apothecon shall have the right to exercise the same audit rights as
GJT may exercise under section 4.6 of the GEOMATRIX Research and Development
Agreement, to the extent relating to the Product only.
4. Genta Jago LLC shall defend, indemnify and hold Apothecon, Inc.
harmless from and against any and all losses, liabilities, damages and expenses
(including reasonable attorneys' fees and costs) that Apothecon suffers as a
result of any claim, demand, action or other proceeding by any Third Party
arising from or relating to the * *, its directors, officers, employees,
consultants or agents in performing its obligations under the GEOMATRIX Research
and Development Agreement, except to the extent such losses, liabilities,
damages and expenses arise from the * or their respective directors, officers,
general partners, employees, consultants, or agents (other than *). Apothecon,
as an Indemnitee, agrees to adhere to and be bound by the terms of section 9.5
of the GEOMATRIX Research and Development Agreement, as though such terms were
fully set forth herein (and with "Article 9" replaced by "Article 4 hereof").
5. To the extent any provisions of the * Agreements or of any of the
GEOMATRIX Agreements conflict in any way with the terms of this Genta Jago LLC
Waiver and Consent Agreement, the terms of this Agreement shall control.
6. This Genta Jago LLC Waiver and Consent Agreement shall be effective
immediately and shall continue in full force and effect until such time as
Apothecon may elect to terminate it by a writing delivered to GJT and to Genta
Jago LLC by a duly authorized officer of Apothecon, or until the termination of
the * Marketing and Development Agreement, whichever occurs first.
7. Any consent, notice or report required or permitted to be given or
made hereunder by one party to the other party shall be in English and in
writing, delivered personally or by registered mail, return receipt requested,
addressed to the other party at its address indicated below or to such other
address as the addressee shall have last furnished in writing to the addressor
(with a copy addressed as well to the attention of its "Legal Counsel") and
shall be effective upon receipt by the addressee.
8. Each party represents and warrants to the other parties hereto the
following:
a) Existence and Power. It (i) is duly organized, validly existing
and in good standing under the laws of the jurisdiction in which
it is organized; (ii) has the requisite power and authority and
the legal right to own and operate its property and assets, to
lease the property and assets it operates under lease, and to
carry on its business as it is now being conducted; and (iii) is
in compliance with all requirements of applicable law, except to
the extent that any noncompliance would not have a material
adverse effect on the properties, business, financial or other
condition of it and would not materially adversely affect its
ability to perform its obligations under this Agreement.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
b) Authorization and Enforcement of Obligations. It (i) has the
requisite power and authority and the legal right to enter into
the Agreement and to perform its obligations hereunder; and (ii)
has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of
its obligations hereunder. This Agreement has been duly executed
and delivered on its behalf, and constitutes a legal, valid,
binding obligation, enforceable against it in accordance with its
terms.
c) No Consents. All necessary consents, approvals and authorizations
of all governmental authorities and other Persons required to be
obtained by it in connection with the execution and performance of
this Agreement have been obtained.
d) No Conflict. The execution and delivery of this Agreement on its
behalf and the performance of its obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or
regulations applicable to it, and (b) do not conflict or are
inconsistent with, or constitute a default under, any contractual
or fiduciary obligation or covenant of it.
9. This Genta Jago LLC Waiver and Consent Agreement shall inure to the
benefit of, and be binding upon each party hereto, and its respective
successors, permitted assigns and legal representatives. Any party may also
assign its rights and obligations under this Agreement without the consent of
the other parties in connection with a merger, consolidation, or the sale of all
or substantially all of its assets to an Affiliate agreeing to be bound by same,
or may otherwise assign its rights or obligations under this Agreement only with
the prior written consent of the other parties hereto. This Agreement shall
survive any merger, consolidation or similar reorganization of either party with
or into another party and no consent for a merger, consolidation or similar
reorganization shall be required hereunder. Any assignment not in accordance
with this Agreement shall be void.
10. This Genta Jago LLC Waiver and Consent Agreement, together with all
other documents 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 that are not set forth herein on which a
party has relied. All terms and conditions of the GEOMATRIX Research and
Development Agreement, to the extent not changed or supplemented by this Genta
Jago LLC Waiver and Consent Agreement, remain in full force and effect.
11. This Genta Jago LLC Waiver and Consent Agreement shall be governed by
and construed in accordance with the laws of Switzerland, without reference to
the conflicts of law principles thereof.
12. No provision of this Genta Jago LLC Waiver and Consent Agreement, or
the benefit thereof may be waived, altered, amended or repealed in whole or in
part except by the written consent of all of the parties hereto, and no such
waiver or changed shall extend beyond the circumstances for which it is granted.
Except as specifically provided for herein, the waiver from time to time by a
party of any of its rights or its failure to exercise any remedy shall not
operate or be construed as a continuing waiver of same or of any other of such
party's rights or remedies hereunder.
13. If any term, covenant or condition of this Genta Jago LLC Waiver and
Consent Agreement or the application thereof to any party or circumstance shall,
to any extent, be held to be invalid or unenforceable, then (1) the remainder of
this Agreement, or the application of such term, covenant or condition to
parties or circumstances other than those as to which it is held invalid or
unenforceable, shall not be affected thereby and each term, covenant or
condition of this Agreement shall be valid and be enforced to the fullest extent
permitted by law; and (2) the parties hereto covenant and agree to renegotiate
any such term, covenant or application thereof in good faith in order to provide
a reasonably acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable, it being
the intent of the parties that the basic purposes of this Agreement are to be
effectuated.
14. Any dispute, claim or controversy between the parties relating to,
arising out of or in any way connected with this Genta Jago LLC Waiver and
Consent Agreement or any term or condition hereof, or the performance by
-4-
a party of its obligations hereunder, whether before or after termination of
this Agreement, 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 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 between the parties the
cost 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 14,
shall be determined by binding arbitration pursuant to this Section 14.
15. It is expressly agreed that the parties are independent contractors
with each other under this Agreement and that the relationship between the two
parties shall not constitute a partnership, joint venture or agency. No 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 any other party,
without the prior consent of the other party to do so.
16. This Genta Jago LLC Waiver and Consent 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.
It shall not be strictly construed against any party hereto.
-5-
IN WITNESS WHEREOF, the parties below have duly executed this Genta Jago
LLC Waiver and Consent Agreement through their respective duly authorized
representatives as of the date first set forth above.
GENTA JAGO DELAWARE, L.L.C.
By: /s/ Xxxxxx X. Xxxxx
--------------------
Xxxxxx X. Xxxxx, Ph.D.
Managing Director
By: /s/ Xxxxxxx Xxxxxxx
--------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
We accept and agree to the foregoing, and acknowledge same by executing this
Genta Jago LLC Waiver and Consent Agreement through our duly authorized
representatives:
GENTA JAGO TECHNOLOGIES BV JAGO PHARMA AG
By /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxxxx Xxxxxxx
------------------- -------------------
Xxxxxx X. Xxxxx, Ph.D. Xx. Xxxxxxx Xxxxxxx
Managing Director President
By /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
GENTA INCORPORATED APOTHECON, INC.
By /s/ Xxxxxx X. Xxxxx By: /s/ Xxx Xxxx
------------------- ------------
Xxxxxx X. Xxxxx, Ph.D. Xxx Xxxx
Chairman and Chief Executive Officer President
-6-
EXHIBIT 3.6(II)
GENTA INCORPORATED
0000 XXXXXXX XXXXXXX XXXXX
XXX XXXXX, XX 00000 XXX
February 28, 1996
Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx
XXX
ATTN: President
Jago Pharma AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxx
XXXXXXXXXXX
ATTN: President
Genta Jago Technologies B.V.
Xxxxxxxxxxxx 00
0000 Xxxxxxxx
XXXXXXXXXXX
ATTN: Executive Committee
Genta Jago Delaware, L.L.C.
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000
XXX
ATTN: President
Re: WAIVER AND CONSENT
Gentlemen:
Reference is hereby made to:
i) An Agreement dated the date hereof by and between Apothecon, Inc.,
a Delaware corporation, and Genta Jago Technologies BV ("GJT"), a
Dutch company, regarding the development of *, using certain
proprietary sustained release technology licensed to GJT by
Jagotec AG (said agreement, as it may be supplemented, changed or
extended from time to time hereafter, is referred to as the "*
Development Agreement"). Each of you acknowledges receipt of a
copy of said agreement; and
ii) An Agreement dated the date hereof by and between Apothecon and
Genta Jago Technologies BV ("GJT'), a Dutch company, regarding the
grant of certain license rights to Apothecon to make, have made,
use and sell * under certain Patent Rights and Know-How licensed
to GJT pertaining to certain proprietary sustained release
technology licensed to GJT by Jagotec AG (said agreement, as it
may be
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-1-
supplemented, changed or extended from time to time hereafter, is
referred to as the "* License Agreement"). Each of you
acknowledges receipt of a copy of said agreement. The * License
Agreement and the * Development Agreement are referred to herein
as the "* Agreements."; and
iii) The Restated GEOMATRIX Research and Development Agreement dated as
of May 12, 1995 by and among GJT, Jago Pharma AG, as Swiss
corporation, Genta Incorporated ("Genta"), a Delaware corporation,
and Genta Jago Delaware, L.L.C. ("Genta Jago LLC"), a Delaware
limited liability company (the "GEOMATRIX Research and Development
Agreement".
iv) The GEOMATRIX License Agreement;
v) The GEOMATRIX Manufacturing License Agreement; and
vi) The GEOMATRIX Supply Agreement.
All capitalized terms not expressly defined in this Waiver and Consent
agreement ("xxx "Xxxxx Xxxxxx and Consent Agreement") have the meaning ascribed
to such term in the * License Agreement.
Jagotec AG and Genta are each 50% owners of the equity and income
interests of GJT. Jagotec and Jago Pharma AG are Affiliates of one another, of
GJT, and of Jago Holding AG, a Swiss corporation. Genta and GPM Generic
Pharmaceuticals Manufacturing, Inc. (the latter entity being an affiliate of
Jagotec AG) are each a 50% owner of the equity and income interests of Genta
Jago LLC. Genta acknowledges, and each of the parties signing below hereby
acknowledges, that it expects to derive, directly or indirectly, substantial
economic benefit as a result of the execution, delivery and performance of the *
License Agreement, the * Development Agreement, and of the GEOMATRIX Agreements.
Therefore, in order to induce Apothecon to execute, deliver and perform the *
Agreements, to make the payments required of Apothecon thereunder, and to accept
GJT's promises to discharge its obligations thereunder and otherwise, and for
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, Genta Incorporated hereby represents, warrants, agrees, and
covenants to and with Apothecon, and each other party signing below hereby
represents, warrants, agrees and concurs, as follows:
1. Notwithstanding any provision in the GEOMATRIX Research and Development
Agreement to the contrary:
a. All applications filed by Genta pursuant to its obligations
under the GEOMATRIX Research and Development Agreement as are necessary
or useful for the Registration of the Product shall be filed in the name
of, and be owned by, Apothecon, and not GJT.
b. All data and results pertaining to the Product generated by
Genta under the Research and Development Agreement shall be owned solely
by Apothecon. Concurrently with the execution and delivery of this Genta
Waiver and Consent Agreement, Genta will turn over to Apothecon all data
and results developed heretofore by or for it pertaining to the Product.
Genta will thereafter report in writing such data and results developed
by or for it not less frequently than quarterly to Apothecon and GJT (and
monthly if requested by either party), and will immediately transmit all
such data to Apothecon by magnetic media or such other method as
Apothecon shall request.
c. In the event that the GEOMATRIX Research and Development
Agreement should terminate, for whatever reason and however effected,
and/or in the event that GJT commences proceedings to dissolve, liquidate
or wind up its affairs, then, in addition to any remedies available to
Apothecon under the * Development and Marketing Agreement at law or in
equity, Genta shall, at Apothecon's request, enter into an agreement with
Apothecon for the development and registration of the Product on terms
and conditions that, to the maximum practicable extent, require Genta to
perform the same obligations and observe the same terms and conditions as
apply to it under the GEOMATRIX Research and Development Agreement
(without regard to Jago Phanna's and Genta Jago LLC's duties or
responsibilities thereunder), and with Apothecon having the
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
rights that GJT otherwise had under such GEOMATRIX Research and
Development Agreement and with APOTHECON assuming GJT's obligations under
such GEOMATRIX Research and Development Agreement to the extent such
obligations do not conflict with or are in addition to the obligations
that Apothecon has under the * Development and Marketing Agreement. In
such event Apothecon shall be entitled to grant to Genta a * under the
Patent Rights and Knowhow solely to conduct the Research and Development
(as such term is defined in the GEOMATRIX Research and Development
Agreement) that Genta is obligated to conduct under the GEOMATRIX
Research and Development Agreement, and any payments for services
performed thereafter by Genta with respect to the development of the
Product shall be made directly by APOTHECON to Genta.
2. Genta shall submit to Apothecon, concurrently with its submission to
GJT, a copy of (i) all reports, statements, invoices, Product Workplans, and
budgets submitted by Genta to GJT or to the Steering Committee relating to the
Product, (ii) a copy of all reports relating to the Product submitted to GJT
under section 5.4 of the GEOMATRIX Research and Development Agreement, and (iii)
a copy of all submissions to, and all responses and approvals obtained from, a
regulatory authority relating to the Product. Genta shall promptly inform
Apothecon of any default by GJT under the GEOMATRIX Research and Development
Agreement. Following any such default, Apothecon shall have the right, but shall
not be under any obligation of any nature whatsoever, expressly or impliedly, to
(i) cure any such default, and/or (ii) pay Genta directly thereafter for all
services performed by it under the GEOMATRIX Research and Development Agreement
that pertain to the Product and deduct and offset same from any monies payable
thereafter by Apothecon to GJT.
3. Apothecon shall have the right to exercise the same audit rights as
GJT may exercise under section 4.6 of the GEOMATRIX Research and Development
Agreement, to the extent relating to the Product only.
4. Genta shall defend, indemnify and hold Apothecon, Inc. harmless from
and against any and all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) that Apothecon suffers as a result of any
claim, demand, action or other proceeding by any Third Party arising from or
relating to the *, its directors, officers, employees, consultants or agents in
performing its obligations under the GEOMATRIX Research and Development
Agreement, except to the extent such losses, liabilities, damages and expenses
arise from the *, or their respective directors, officers, general partners,
employees, consultants, or agents (other than *). Apothecon, as an Indemnitee,
agrees to adhere to and be bound by the terms of section 9.5 of the GEOMATRIX
Research and Development Agreement, as though such terms were fully set forth
herein (and with "Article 9" replaced by "Article 4 hereof").
5. To the extent any provisions of the * Agreements or of any of the
GEOMATRIX Agreements conflict in any way with the terms of this Genta Waiver and
Consent Agreement, the terms of this agreement shall control.
6. This Waiver and Consent shall be effective immediately and shall
continue in full force and effect until such time as Apothecon may elect to
terminate it by a writing delivered to GJT and to Genta by a duly authorized
officer of Apothecon, or until the termination of the * Marketing and
Development Agreement, whichever occurs first.
7. Any consent, notice or report required or permitted to be given or
made hereunder by one party to the other party shall be in English and in
writing, delivered personally or by registered mail, return receipt requested,
addressed to the other party at its address indicated below or to such other
address as the addressee shall have last furnished in writing to the addressor
(with a copy addressed as well to the attention of its "Legal Counsel") and
shall be effective upon receipt by the addressee.
8. Each party represents and warrants to the other parties hereto the
following:
a) Existence and Power. It (i) is duly organized, validly
existing and in good standing under the laws of the
jurisdiction in which it is organized; (ii) has the
requisite power and authority and the legal right to own
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
and operate its property and assets, to lease the property
and assets it operates under lease, and to carry on its
business as it is now being conducted; and (iii) is in
compliance with all requirements of applicable law, except
to the extent that any noncompliance would not have a
material adverse effect on the properties, business,
financial or other condition of it and would not materially
adversely affect its ability to perform its obligations
under this Agreement.
b) Authorization and Enforcement of Obligations. It (i) has the
requisite power and authority and the legal right to enter
into the Agreement and to perform its obligations hereunder;
and (ii) has taken all necessary action on its part to
authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on its behalf, and
constitutes a legal, valid, binding obligation, enforceable
against it in accordance with its terms.
c) No Consents. All necessary consents, approvals and
authorizations of all governmental authorities and other
Persons required to be obtained by it in connection with
the execution and performance of this Agreement have been
obtained.
d) No Conflict. The execution and delivery of this Agreement on
its behalf and the performance of its obligations hereunder
(a) do not conflict with or violate any requirement of
applicable laws or regulations applicable to it, and (b) do
not conflict or are inconsistent with, or constitute a
default under, any contractual or fiduciary obligation or
covenant of it.
9. This Genta Waiver and Consent Agreement shall inure to the benefit of,
and be binding upon each party hereto, and its respective successors, permitted
assigns and legal representatives. Any party may also assign its rights and
obligations under this Agreement without the consent of the other parties in
connection with a merger, consolidation or the sale of all or substantially all
of its assets to an Affiliate agreeing to be bound by same, or may otherwise
assign its rights or obligations under this Agreement only with the prior
written consent of the other parties hereto. This Agreement shall survive any
merger, consolidation or similar reorganization of either party with or into
another party and no consent for a merger, consolidation or similar
reorganization shall be required hereunder. Any assignment not in accordance
with this Agreement shall be void.
10. This Genta Waiver and Consent Agreement, together with all of the
documents 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 that are not set forth herein on which a party has relied.
All other terms and conditions of the GEOMATRIX Research and Development
Agreement, to the extent not changed or supplemented by this Genta Waiver and
Consent Agreement, remain in full force and effect.
11. This Genta Waiver and Consent Agreement shall be governed by and
construed in accordance with the laws of Switzerland, without reference to the
conflicts of law principles thereof.
12. No provision of this Genta Waiver and Consent Agreement, or the
benefit thereof may be waived, altered, amended or repealed in whole or in part
except by the written consent of all of the parties hereto, and no such waiver
or changed shall extend beyond the circumstances for which it is granted. Except
as specifically provided for herein, the waiver from time to time by a party of
any of its rights or its failure to exercise any remedy shall not operate or be
construed as a continuing waiver of same or of any other of such party's rights
or remedies hereunder.
13. If any term, covenant or condition of this Genta Waiver and Consent
Agreement or the application thereof to any party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (1) the remainder of this
Agreement, or the application of such term, covenant or condition to parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law;
and (2) the parties hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application
-4-
thereof that is invalid or unenforceable, it being the intent of the parties
that the basic purposes of this Agreement are to be effectuated.
14. Any dispute, claim or controversy between the parties relating to,
arising out of or in any way connected with this Genta Waiver and Consent
Agreement or any term or condition hereof, or the performance by a party of its
obligations hereunder, whether before or after termination of this Agreement,
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 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 between the parties the cost 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 14, shall be
determined by binding arbitration pursuant to this Section 14.
15. It is expressly agreed that the parties are independent contractors
with one another under this Agreement and that the relationship between the two
parties shall not constitute a partnership, joint venture or agency. No 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 any other party,
without the prior consent of the other party to do so.
16. This Genta Waiver and Consent 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. It shall not be strictly
construed against any party hereto.
-5-
IN WITNESS WHEREOF, the parties below have duly executed this Genta Waiver
and Consent Agreement through their respective duly authorized representatives
as of the date first set forth above.
GENTA INCORPORATED
By: /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
Chairman and Chief Executive Officer
We accept and agree to the foregoing, and acknowledge same by executing this
Genta Waiver and Consent Agreement through our duly authorized representatives:
GENTA JAGO TECHNOLOGIES BV JAGO PHARMA AG
By /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxxxx Xxxxxxx
------------------- -------------------
Xxxxxx X. Xxxxx, Ph.D. Xx. Xxxxxxx Xxxxxxx
Managing Director President
By /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
GENTA JAGO DELAWARE, L.L.C.
By /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
Managing Director
By /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
APOTHECON, INC.
By /s/ Xxx Xxxx
------------
Xxx Xxxx
President
-6-
EXHIBIT 3.6(III)
JAGO PHARMA AG
XXXXXXXXXXXXXXX 00
XX-0000 XXXXXXX
XXXXXXXXXXX
February 28, 1996
Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx
XXX
ATTN: President
Genta Jago Technologies B.V., Swiss Branch
Xxxxxxxxxxxx 00
0000 Xxxxxxxx
XXXXXXXXXXX
ATTN: Executive Management Committee
Genta Jago Delaware, L. L - C
3550 General Atomics Court
Xxx Xxxxx, XX 00000
XXX
ATTN: President
Genta Incorporated
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000
XXX
ATTN: President
Re: WAIVER AND CONSENT
Gentlemen:
Reference is hereby made to:
i) An Agreement dated the date hereof by and between Apothecon, Inc.,
a Delaware corporation, and Genta Jago Technologies BV ("GJT"), a
Dutch company, regarding the development of *, using certain
proprietary sustained release technology licensed to GJT by
Jagotec AG (said agreement, as it may be supplemented, changed or
extended from time to time hereafter, is referred to as the "*
Development Agreement"). Each of you acknowledges receipt of a
copy of said agreement; and
ii) An Agreement dated the date hereof by and between Apothecon and
Genta Jago Technologies BV ("GJT"), a Dutch company, regarding the
grant of certain license rights to Apothecon to make, have made,
use and sell * under certain Patent Rights and Know-How licensed
to GJT pertaining to certain proprietary sustained release
technology licensed to GJT by Jagotec AG (said agreement, as it
may be
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
supplemented, changed or extended from time to time hereafter, is
referred to as the "* License Agreement"). Each of you
acknowledges receipt of a copy of said agreement. The * License
Agreement and the * Development Agreement are referred to herein
as the "* Agreements"; and
iii) The Restated GEOMATRIX Research and Development Agreement dated as
of May 12, 1995 by and among GJT, Jago Pharma AG, as Swiss
corporation, Genta Incorporated ("Genta"), a Delaware corporation,
and Genta Jago Delaware, L.L.C. ("Genta Jago LLC), a Delaware
limited liability company (the "GEOMATRIX Research and Development
Agreement".
All capitalized terms not expressly defined in this Waiver and Consent
agreement ("the "Jago Pharma Waiver and Consent Agreement") have the meaning
ascribed to such term in the * License Agreement.
Jagotec AG and Genta are each 50% owners of the equity and income interests
of GJT. Jagotec and Jago Pharma AG are Affiliates of one another, of GJT, and of
Jago Holding AG, a Swiss corporation. Genta and GPM Generic Pharmaceuticals
Manufacturing Inc. (the latter entity being an Affiliate of Jagotec AG) are each
a 50% owner of the equity and income interests of Genta Jago LLC. Jago Pharma AG
acknowledges, and each of the parties signing below hereby acknowledges, that it
expects to derive substantial economic benefit, directly or indirectly, as a
result of the execution, delivery and performance of the * License Agreement,
the * Development Agreement, and of the GEOMATRIX Agreements. Therefore, in
order to induce Apothecon to execute, deliver and perform the * Agreements, to
make the payments required of Apothecon thereunder, and to accept GJT's promises
to discharge its obligations thereunder and otherwise, and for other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, Jago Pharma AG hereby represents, warrants, agrees, and covenants
to and with Apothecon, and each other party signing below hereby represents,
warrants, agrees and concurs, as follows:
1. (a) Notwithstanding any provision in the GEOMATRIX Research and
Development Agreement to the contrary:
i. All applications filed by Jago Pharma AG pursuant to its obligations
under the GEOMATRIX Research and Development Agreement as are necessary
or useful for the Registration of the Product shall be filed in the name
of, and be owned by, Apothecon, and not GJT.
ii. All data and results pertaining to the Product generated by Jago
Pharma AG under the Research and Development Agreement shall be owned
solely by Apothecon. Concurrently with the execution and delivery of this
Jago Pharma Waiver and Consent Agreement, Jago Pharma will turn over to
Apothecon all data and results heretofore developed by or for it
pertaining to the Product. Jago Pharrna AG will thereafter report in
writing such data and results developed by or for it not less frequently
than quarterly to Apothecon and GJT (and monthly if requested by either
party), and will immediately transmit all such data to Apothecon by
magnetic media or such other method as Apothecon shall request.
iii. In the event that the GEOMATRIX Research and Development Agreement
should terminate, for whatever reason and however effected, then, in
addition to any remedies available to APOTHECON under the * Development
and Marketing Agreement at law or in equity, Jago Pharma AG shall, at
Apothecon's election and request, enter into an agreement with Apothecon
for the development and registration of the Product on terms and
conditions that, to the maximum practicable extent, require Jago Pharma
AG to perform the same obligations and observe the same terms and
conditions as apply to it under the GEOMATRIX Research and Development
Agreement (without regard to Genta and Genta Jago LLC's duties or
responsibilities thereunder), and with Apothecon having the rights that
GJT otherwise had under such GEOMATRIX Research and Development Agreement
and with APOTHECON assuming GJT's obligations under such GEOMATRIX
Research and Development Agreement to the extent such obligations do not
conflict with or are in addition to the obligations that Apothecon has
under the * Development and Marketing Agreement. In such event Apothecon
shall be entitled to grant to Jago Pharma AG a * under the Patent Rights
and Knowhow solely to conduct the Research and Development (as such term
is defined in the GEOMATRIX
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
Research and Development Agreement) that Jago Pharma AG is obligated to
conduct under the GEOMATRIX Research and Development Agreement, and any
payments for services performed thereafter by Jago Pharma AG with respect
to the development of the Product shall be made directly by APOTHECON to
Jago Pharma AG.
(b) If GJT breaches the * Development and Marketing Agreement with
respect to the development of the Product in a manner that entitles
APOTHECON to terminate same pursuant to section 11.2.2.1 or 11. 2.2.2
thereof, or makes an untrue statement that entitles APOTHECON to
terminate same pursuant to section 11.2.4.1 thereof, and/or in the event
that GJT commences proceedings to dissolve, liquidate or wind up its
affairs, then, in addition to any remedies available to it under said *
Development and Marketing Agreement or available to it at law or in
equity, APOTHECON may elect (by delivering a writing to GJT and Jago
Pharma AG of APOTHECON's intent to exercise its option), for Jago Pharma
AG to, and Jago Pharma AG agrees that it will, promptly enter into an
agreement with APOTHECON under which: (i) Jago Pharma will, to the extent
it has the right to do so, ensure that all licenses, sublicenses and
other rights and privileges granted by GJT under the * Development and
Marketing Agreement shall continue without change, and (ii) Jago Pharma
will assume all rights and obligations of GJT under articles 3, 4, 5, 6,
11.4.5, 12, 14, 15.1, and 15.2 of the Development and Marketing Agreement
and will promptly cure any defaults of GJT under said articles, any
payments to be made thereafter by APOTHECON under said articles shall
thereafter be paid to Xxxx Xxxxxx, and APOTHECON shall continue to enjoy
all rights and privileges granted under said articles.
2. Jago Pharma shall submit to Apothecon, concurrently with its submission
to GJT, a copy of (i) all reports, statements, invoices, Product Workplans, and
budgets submitted by Jago Pharma AG to GJT or to the Steering Committee relating
to the Product, (ii) a copy of all reports relating to the Product submitted to
GJT under section 5.4 of the GEOMATRIX Research and Development Agreement, and
(iii) a copy of all submissions to, and all responses and approvals obtained
from, a regulatory authority relating to the Product. Jago Pharma AG shall
promptly inform Apothecon of any default by GJT under the GEOMATRIX Research and
Development Agreement. Following any such default, Apothecon shall have the
right, but shall not be under any obligation of any nature whatsoever, expressly
or impliedly, to (i) cure any such default, and/or (ii) pay Jago Pharma AG
directly thereafter for all services performed by it under the GEOMATRIX
Research and Development Agreement that pertain to the Product and deduct and
offset same from any monies payable thereafter by Apothecon to GJT.
3. Apothecon shall have the right to exercise the same audit rights as GJT
may exercise under section 4.6 of the GEOMATRIX Research and Development
Agreement, to the extent relating to the Product only.
4. Jago Pharma AG shall defend, indemnify and hold Apothecon, Inc. harmless
from and against any and all losses, liabilities, damages and expenses
(including reasonable attorneys' fees and costs) that Apothecon suffers as a
result of any claim, demand, action or other proceeding by any Third Party
arising from or relating to the *, its directors, officers, employees,
consultants or agents in performing its obligations under the GEOMATRIX Research
and Development Agreement, except to the extent such losses, liabilities,
damages and expenses arise from the *, or their respective directors, officers,
general partners, employees, consultants, or agents (other than *). Apothecon,
as an Indemnitee, agrees to adhere to and be bound by the terms of section 9.5
of the GEOMATRIX Research and Development Agreement, as though such terms were
fully set forth herein (and with "Article 9" replaced by "Article 4 hereof").
5. To the extent any provisions of the * Agreements or of any of the
GEOMATRIX Agreements conflict in any way with the terms of this Jago Pharma
Waiver and Consent Agreement, the terms of this Agreement shall control.
6. This Waiver and Consent shall be effective immediately and shall continue
in full force and effect until such time as Apothecon may elect to terminate it
by a writing delivered to GJT and to Jago Pharma by a duly authorized officer of
Apothecon, or until the termination of the * Marketing and Development
Agreement, whichever occurs first.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
7. Any consent, notice or report required or permitted to be given or made
hereunder by one party to the other party shall be in English and in writing,
delivered personally or by registered mail, return receipt requested, addressed
to the other party at its address indicated below or to such other address as
the addressee shall have last furnished in writing to the addressor (with a copy
addressed as well to the attention of its "Legal Counsel") and shall be
effective upon receipt by the addressee.
8. Each party represents and warrants to the other parties hereto the following:
a) Existence and Power. It (i) is duly organized, validly existing
and in good standing under the laws of the jurisdiction in which it is
organized; (ii) has the requisite power and authority and the legal right
to own and operate its property and assets, to lease the property and
assets it operates under lease, and to carry on its business as it is now
being conducted; and (iii) is in compliance with all requirements of
applicable law, except to the extent that any noncompliance would not
have a material adverse effect on the properties, business, financial or
other condition of it and would not materially adversely affect its
ability to perform its obligations under this Agreement.
b) Authorization and Enforcement of Obligations. It (i) has the
requisite power and authority and the legal right to enter into the
Agreement and to perform its obligations hereunder; and (ii) has taken
all necessary action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on its behalf, and
constitutes a legal, valid, binding obligation, enforceable against it in
accordance with its terms.
c) No Consents. All necessary consents, approvals and
authorizations of all governmental authorities and other Persons required
to be obtained by it in connection with the execution and performance of
this Agreement have been obtained.
d) No Conflict. The execution and delivery of this Agreement on
its behalf and the performance of its obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or
regulations applicable to it, and (b) do not conflict or are inconsistent
with, or constitute a default under, any contractual or fiduciary
obligation or covenant of it.
9. This Jago Pharma Waiver and Consent Agreement shall inure to the benefit
of, and be binding upon each party hereto, and its respective successors,
permitted assigns and legal representatives. Any party may also assign its
rights and obligations under this Agreement without the consent of the other
parties in connection with a merger, consolidation, or the sale of all or
substantially all of its assets to an Affiliate agreeing to be bound by same, or
may otherwise assign its rights or obligations under this Agreement only with
the prior written consent of the other parties hereto. This Agreement shall
survive any merger, consolidation or similar reorganization of either party with
or into another party and no consent for a merger, consolidation or similar
reorganization shall be required hereunder. Any assignment not in accordance
with this Agreement shall be void.
10. This Jago Pharma Waiver and Consent Agreement, together with all other
documents to the extent 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 that are not set forth herein
on which a party has relied. All terms and conditions of the GEOMATRIX Research
and Development Agreement, to the extent not changed or supplemented by this
Jago Pharma Waiver and Consent Agreement, remain in full force and effect.
11. This Jago Pharma Waiver and Consent Agreement shall be governed by and
construed in accordance with the laws of Switzerland, without reference to the
conflicts of law principles thereof.
12. No provision of this Jago Pharma Waiver and Consent Agreement, or the
benefit thereof may be waived, altered, amended or repealed in whole or in part
except by the written consent of all of the parties hereto, and no such waiver
or changed shall extend beyond the circumstances for which it is granted. Except
as specifically provided for herein, the waiver from time to time by a party of
any of its rights or its failure to exercise any remedy
-4-
shall not operate or be construed as a continuing waiver of same or of any other
of such party's rights or remedies hereunder.
13. If any term, covenant or condition of this Jago Pharma Waiver and
Consent Agreement or the application thereof to any party or circumstance shall,
to any extent, be held to be invalid or unenforceable, then (1) the remainder of
this Agreement, or the application of such term, covenant or condition to
parties or circumstances other than those as to which it is held invalid or
unenforceable, shall not be affected thereby and each term, covenant or
condition of this Agreement shall be valid and be enforced to the fullest extent
permitted by law; and (2) the parties hereto covenant and agree to renegotiate
any such term, covenant or application thereof in good faith in order to provide
a reasonably acceptable alternative to the term, covenant or condition of this
Agreement or the application thereof that is invalid or unenforceable, it being
the intent of the parties that the basic purposes of this Agreement are to be
effectuated.
14. Any dispute, claim or controversy between the parties relating to,
arising out of or in any way connected with this Jago Pharma Waiver and Consent
Agreement or any term or condition hereof, or the performance by a party of its
obligations hereunder, whether before or after termination of this Agreement,
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 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 between the parties the cost 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 14, shall be
deter-mined by binding arbitration pursuant to this Section 14.
15. It is expressly agreed that the parties are independent contractors with
each other under this Agreement and that the relationship between the parties
shall not constitute a partnership, joint venture or agency. No 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 any other party, without
the prior consent of the other party to do so.
16. This Jago Pharma Waiver and Consent 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. It shall not be strictly
construed against any party hereto.
-5-
IN WITNESS WHEREOF, the parties below have duly executed this Jago Pharma
Waiver and Consent Agreement through their respective duly authorized
representatives as of the date first set forth above.
JAGO PHARMA AG
By /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
President
We accept and agree to the foregoing, and acknowledge same by executing this
Jago Pharma Waiver and Consent Agreement through our duly authorized
representatives:
GENTA JAGO TECHNOLOGIES BV
By: /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
Managing Director
By: /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
GENTA INCORPORATED
By: /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
Chairman and Chief Executive Officer
GENTA JAGO DELAWARE, L.L.C.
By: /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
Managing Director
By: /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
Managing Director
APOTHECON, INC.
By: /s/ Xxx Xxxx
------------
Xxx Xxxx
President
-6-
EXHIBIT 3.6(IV)
JAGOTEC AG
XXXXXXXXXX 00
XX-0000 XXXXXXXXX, XXXXXXXXXXX
February 28, 1996
Apothecon, Inc.
000 Xxxxxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
XXX
Attn.: President
Genta Jago Technologies BV
Xxxxxxxxxxxx 00
0000 Xxxxxxxx
XXXXXXXXXXX
Re: WAIVER AND CONSENT
Gentlemen:
Reference is hereby made to:
i) An Agreement dated the date hereof by and between Apothecon, Inc., a
Delaware corporation, and Genta Jago Technologies BV ("GJT"), a Dutch company,
regarding the development and marketing of *, using certain proprietary
sustained release technology licensed to GJT by Jagotec AG (said agreement, as
it may be supplemented, changed or extended from time to time hereafter, is
referred to as the "* Development and Marketing Agreement"). You acknowledge
receipt of a copy of said agreement; and
ii) An Agreement dated the date hereof by and between Apothecon and Genta
Jago Technologies BV ("GJT"), a Dutch company, regarding the grant of certain
license rights to Apothecon to make, have made, use and sell * under certain
Patent Rights and Know-How licensed to GJT pertaining to certain proprietary
sustained release technology licensed to GJT by Jagotec AG (said agreement, as
it may be supplemented, changed or extended from time to time hereafter, is
referred to as the "* License Agreement"). You acknowledge receipt of a copy of
said agreement. The * License Agreement and the * Development and Marketing
Agreement are referred to herein as the "* Agreements.";
All capitalized terms not expressly defined in this Waiver and Consent
agreement ("the "Jagotec Waiver and Consent Agreement") have the meaning
ascribed to such term in the * License Agreement.
Jagotec AG ("Jagotec"), a Swiss corporation, is party to a Restated
GEOMATRIX License Agreement between Jagotec and GJT dated May 12, 1995 (said
agreement, as it may be supplemented, changed or extended from time to time, is
referred to herein as the "License Agreement") and to a Restated GEOMATRIX
Manufacturing License Agreement between Jagotec and GJT dated May 12, 1995 (said
agreement, as it may be supplemented, changed or extended from time to time, is
referred to herein as the "Manufacturing License Agreement").
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
Jagotec is a 50% owner of the equity and income interests of GJT. Jagotec
is an Affiliate of GJT and of Jago Holding AG, a Swiss corporation. Accordingly,
the undersigned expects to derive, directly or indirectly, substantial economic
benefit as a result of the execution, delivery and performance of the *
Agreements. Therefore, in order to induce Apothecon to execute, deliver and
perform the * Agreements, to make the payments required of Apothecon thereunder,
and to accept GJT's promises to discharge its obligations thereunder and
otherwise, Jagotec hereby represents, warrants, agrees, and covenants to and
with GJT and Apothecon as follows:
1. Jagotec agrees that any license rights, sublicense rights and other
rights granted or extended by GJT to Apothecon under the * Agreements are not
subject to the terms and conditions of the License Agreement and the
Manufacturing License Agreement and waives any rights Jagotec may have with
respect to the enforcement of same against Apothecon. Jagotec further agrees
that Apothecon, to the extent it is a subcontractee or sublicensee of GJT's
rights and obligations under the License Agreement and the Manufacturing
Agreement, shall not be bound by any and all obligations and undertakings of GJT
under either of said Agreements, and waives any rights Jagotec may have with
respect to the enforcement of same against Apothecon.
2. (a) Jagotec agrees that, in the event of an event that the License
Agreement and/or the Manufacturing License Agreement is or are terminated, for
whatever reason and whether by action taken by Jagotec, GJT or both, and
notwithstanding any provision (including without limitation section 11.4) to the
contrary in the License Agreement and in the Manufacturing Agreement, all
licenses, sublicenses and other rights and privileges granted or extended to
Apothecon under the * Agreements shall continue and remain in full force and
effect in accordance with their terms, without further action or election on the
part of Apothecon, and Jagotec shall be deemed simultaneously to have assumed
the rights and obligations of GJT under the * Agreements and will promptly cure
all defaults of GJT thereunder.
(b) If GJT breaches the * License Agreement in a manner that
entitles APOTHECON to terminate same pursuant to section 11.2.2.1 or 11.2.2.2
thereof, or makes an untrue statement that entitles APOTHECON to terminate same
pursuant to section 11.2.4.1 thereof, and/or in the event that GJT commences
proceedings to dissolve, liquidate or wind up its affairs, then, in addition to
any remedies available to it under said Agreement or at law or in equity,
APOTHECON may elect (by delivering a writing to GJT and Jagotec of APOTHECON's
intent to exercise such option) for Jagotec to, and Jagotec agrees that it will,
promptly enter into a new, separate agreement with APOTHECON under which (i) all
licenses, sublicenses and other rights and privileges granted by GJT under the *
License Agreement shall continue without further action or election on the part
of APOTHECON, (ii) Jagotec will assume all rights and obligations of GJT and
promptly cure all defaults of GJT thereunder, and (iii) all payments that would
otherwise have been made thereafter by APOTHECON under the * License Agreement
shall thereafter be paid to Jagotec.
(c) If GJT fails to make a payment when due under its Restated
Working Capital Agreement dated as of May 12, 1995 (as amended by a First
Amendment thereto dated as of July 11, 1995 and as the same may be amended from
time to time hereafter, and including any successor agreement thereto), between
GJT and Genta, Incorporated, a Delaware corporation ("Genta"), GJT and/or
Jagotec shall promptly inform APOTHECON of same, and APOTHECON may elect (by
delivering a writing to GJT and Jagotec of APOTHECON's intent to exercise such
option) at any time thereafter to terminate the * License Agreement and for
Jagotec to, and Jagotec agrees that it will, promptly enter into a new, separate
agreement with APOTHECON under which (i) all licenses, sublicenses and other
rights and privileges granted by GJT under the * License Agreement shall
continue without further action or election on the part of APOTHECON, and (ii)
Jagotec will assume all rights and obligations of GJT and promptly cure all
defaults of GJT thereunder; provided, however, that all payments that would
otherwise have been made thereafter by APOTHECON under the * License Agreement
and otherwise under such new, separate agreement shall thereafter continue to be
paid to GJT by APOTHECON, until APOTHECON is duly instructed otherwise in
writing by GJT and Jagotec AG.
3. To the extent any provisions of the * Agreements supplement or conflict
with the terms of the GEOMATRIX Agreements, the terms of the * Agreements shall
control.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-2-
4. This Jagotec Waiver and Consent Agreement shall inure to the benefit of
Apothecon, its successors, assigns and legal representatives, as well as GJT,
its successors, assigns and legal representatives, and shall bind the Jagotec
and its successors and assigns. This Jagotec Waiver and Consent Agreement sets
forth the entire understanding of the GJT, Jagotec and Apothecon with respect to
the subject matter hereof, and there are no other promises, representations or
understandings, written or oral, not set forth herein.
5. Each party represents and warrants to the other parties hereto the
following:
a) Existence and Power. It (i) is duly organized, validly existing
and in good standing under the laws of the jurisdiction in which it is
organized; (ii) has the requisite power and authority and the legal right
to own and operate its property and assets, to lease the property and
assets it operates under lease, and to carry on its business as it is now
being conducted; and (iii) is in compliance with all requirements of
applicable law, except to the extent that any noncompliance would not
have a material adverse effect on the properties, business, financial or
other condition of it and would not materially adversely affect its
ability to perform its obligations under this Agreement.
b) Authorization and Enforcement of Obligations. It (i) has the
requisite power and authority and the legal right to enter into the
Agreement and to perform its obligations hereunder; and (ii) has taken
all necessary action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on its behalf, and
constitutes a legal, valid, binding obligation, enforceable against it in
accordance with its terms.
c) No Consents. All necessary consents, approvals and
authorizations of all governmental authorities and other Persons required
to be obtained by it in connection with the execution and performance of
this Agreement have been obtained.
d) No Conflict. The execution and delivery of this Agreement on
its behalf and the performance of its obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or
regulations applicable to it, and (b) do not conflict or are inconsistent
with, or constitute a default under, any contractual or fiduciary
obligation or covenant of it.
6. This Jagotec Waiver and Consent Agreement shall be effective
immediately and shall continue in full force and effect until such time as
Apothecon may elect to terminate it by a writing delivered to GJT and to Jagotec
by a duly authorized officer of Apothecon, or until the termination of the *
Agreements, whichever occurs first.
7. Any consent, notice or report required or permitted to be given or made
hereunder by one party to the other party shall be in English and in writing,
delivered personally or by registered mail, return receipt requested, addressed
to the other party at its address indicated below or to such other address as
the addressee shall have last furnished in writing to the addressor and shall be
effective upon receipt by the addressee.
If to Jagotec: Jagotec AG
c/o Jago Pharma AG
Xxxxxxxxxxxxxxx 00
XX-0000 Xxxxxxx, Xxxxxxxxxxx
Attention: Xx. Xxxxxxx Xxxxxxx
with a copy to: Xxxxxxxxxxxx Xxxxx & Xxxxxxxxxxx
Xxxxxxxxxxxxxxxx 0
Xxxxxxxx 0000
XX-0000 Xxxxxx, Xxxxxxxxxxx
Attention: Xx. Xxxxxx X. Xxxxxxxxxxxx
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-3-
If to GJT: Genta Jago Technologies BV
Swiss Branch
Xxxxxxxxxxxx 00
0000 Xxxxxxxx, Xxxxxxxxxxx
Attention: Executive Management Committee
with copies to: Genta Incorporated
0000 Xxxxxxx Xxxxxxx Xxxxx
Xxx Xxxxx, XX 00000, X.X.X.
Attention: Xxxxxx X. Xxxxx, Ph.D.
and: Pillsbury Madison & Sutro
000 Xxxxxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxxxxxxx, XX 00000, X.X.X.
Attention: Xxxxxx X. Xxxxxx, Xx., Esq.
If to
APOTHECON: Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000 XXX
Attention: President
with a copy to: Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000 XXX
Attention: Corporate Legal Counsel
8. This Jagotec Waiver and Consent Agreement shall be governed by and
construed in accordance with the laws of Switzerland, without reference to the
conflicts of law principles thereof.
9. Any dispute, claim or controversy between the parties relating to,
arising out of or in any way connected with this Jagotec Waiver and Consent
Agreement or any term or condition hereof, or the performance by either party of
its obligations hereunder, whether before or after termination of this Jagotec
Waiver and Consent Agreement, 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 the other party. 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 between the parties
the cost 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 9,
shall be determined by binding arbitration pursuant to this Section 9.
10. It is expressly agreed that the parties are each independent
contractors with one another under this Agreement and that the relationship
between the two 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 consent of the other party to do
so.
11. The provisions of this Jagotec Waiver and Consent Agreement may not
be waived, altered, amended or repealed in whole or in part except by the
written consent of all of the parties hereto.
-4-
12. The terms, covenants, conditions and provisions contained herein,
together with all other documetts to the extent 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.
13. This Jagotec Waiver and Consent 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. It shall not be strictly
construed against any party hereto.
14. This Jagotec Waiver and Consent Agreement shall inure to the benefit
of, and be binding upon each party hereto, and its respective successors,
permitted assigns and legal representatives. Any party may also assign its
rights and obligations under this Agreement without the consent of the other
parties in connection with a merger, consolidation, or the sale of all or
substantially all of its assets to an Affiliate agreeing to be bound by same, or
may otherwise assign its rights or obligations under this Agreement only with
the prior written consent of the other parties hereto. This Agreement shall
survive any merger, consolidation or similar reorganization of either party with
or into another party and no consent for a merger, consolidation or similar
reorganization shall be required hereunder. Any assignment not in accordance
with this Agreement shall be void.
15. No provision of this Jagotec Waiver and Consent Agreement, or the
benefit thereof may be waived, altered, amended or repealed in whole or in part
except by the written consent of all of the parties hereto, and no such waiver
or changed shall extend beyond the circumstances for which it is granted. Except
as specifically provided for herein, the waiver from time to time by a party of
any of its rights or its failure to exercise any remedy shall not operate or be
construed as a continuing waiver of same or of any other of such party's rights
or remedies hereunder.
16. If any term, covenant or condition of this Jagotec Waiver and Consent
Agreement or the application thereof to any party or circumstance shall, to any
extent, be held to be invalid or unenforceable, then (1) the remainder of this
Agreement, or the application of such term, covenant or condition to parties or
circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of this
Agreement shall be valid and be enforced to the fullest extent permitted by law;
and (2) the parties hereto covenant and agree to renegotiate any such term,
covenant or application thereof in good faith in order to provide a reasonably
acceptable alternative to the term, covenant or condition of this Agreement or
the application thereof that is invalid or unenforceable, it being the intent of
the parties that the basic purposes of this Agreement are to be effectuated.
-5-
IN WITNESS WHEREOF, the parties below have duly executed this Jagotec
Waiver and Consent Agreement through their respective duly authorized
representatives as of the date first set forth above.
JAGOTEC AG
By: /s/ Xxxxxxxx Xxxxxxx
--------------------
Xx. Xxxxxxx Xxxxxxx
President
We accept and agree to the foregoing, and acknowledge same by executing this
Jagotec Waiver and Consent Agreement through our duly authorized
representatives:
GENTA JAGO TECHNOLOGIES BV
By: /s/ Xxxxxxx Xxxxxxx
-------------------
Xx.Xxxxxxx Xxxxxxx
Managing Director
By: /s/ Xxxxxx X. Xxxxx
-------------------
Xxxxxx X. Xxxxx, Ph.D.
managing Director
APOTHECON, INC.
By: /s/ Xxx Xxxx
------------
Title: VP/GM
Date:
-6-
EXHIBIT 9.1
LIST OF GEOMATRIX TRADEMARKS
--------------------------------------------------------------------------------
Country TM-No. Issue Date
------------------------------- ------------ --------
International 522 445 April 8, 1988
Registration (25 countries)
Canada 369 959 May 29, 0000
Xxxxxxxxxxx 360 353 November 11, 1987
United Kingdom (class 1) 1415 000 Xxxxx 00, 0000
Xxxxxx Xxxxxxx (class 5) 1353 226 August 2, 1995 *)
Greece 90 337 August 25, 0000
Xxxxx 2578 899 September 30, 1993
New Zealand 185 989 July 28, 1995
Portugal **) 303 292 September 12, 0000
Xxxxxx 223 000 Xxx 00, 0000
Xxxxxx Xxxxxx 1562 880 October 31, 1989
*) renewal date
**) registration not yet granted
