EXHIBIT 10.89
CONFIDENTIAL TREATMENT REQUESTED
DEVELOPMENT AND MARKETING 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"); and
WHEREAS, APOTHECON is interested in developing, manufacturing, 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; and
WHEREAS, all licenses and rights to make, have made, use and sell the
Product have been granted pursuant to a license agreement of even date herewith
between GJT and APOTHECON (said license agreement, as the same may be extended,
supplemented or changed hereafter, referred to hereinafter as the "* License
Agreement"); and
WHEREAS, the parties desire to provide herein for the development of
the Product, all upon the terms and conditions set forth below.
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;
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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 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) hereto.
"Effective Date" means the date when this Agreement is executed and
delivered by the 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 License Agreement, the GEOMATRIX Supply Agreement, and the GEOMATRIX
Research and Development Agreement (each, individually, a "GEOMATRIX
Agreement").
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"GEOMATRIX License Agreement" shall mean the Restated GEOMATRIX License
Agreement dated as of May 12, 1995 between GJT and Jagotec.
"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, as 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, as 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 of the * License Agreement.
"Jagotec" means Jagotec AG, a Swiss corporation, having a place of
business at Xxxxxxxxxx 00, XX-0000 Xxxxxxxxx, Xxxxxxxxxxx.
"Jago Pharma" means Jago Pharma AG, a Swiss corporation, having a place
of business at Xxxxxxxxxxxxxxx 00, XX-0000 Xxxxxxx, Xxxxxxxxxxx.
"* License Agreement" means the agreement referred to 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
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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, 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 *
days or more during the applicable reporting period, less such invoiced amounts
outstanding and unpaid for * days 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 GJI 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 *, and
which incorporates, is based on and is derived by use of the GEOMATRIX
Technology.
"Region I" shall mean all countries located *, 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.
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"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
(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 * 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 hereof.
"Subcontractee" shall have the meaning ascribed to such term in Article
14 hereof.
"Territory" shall mean *.
"Third Party" means any Person other than GJT or APOTHECON, 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 unappeased 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. [Intentionally omitted.]
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. GJT covenants and agrees to
comply with its duties and obligations under the GEOMATRIX License Agreement,
the GEOMATRIX Manufacturing License Agreement, the GEOMATRIX Supply Agreement,
and the GEOMATRIX Research and Development Agreement (collectively, the
"GEOMATRIX Agreements"), and to use best efforts to enforce its rights and
privileges under each such GEOMATRIX Agreement so as not to diminish or
adversely affect in any material respect the rights and privileges available to
APOTHECON under this Agreement. GJT agrees not to terminate any such GEOMATRIX
Agreement or waive in any material respect any rights or privileges available to
it under any such GEOMATRIX Agreement which would have the effect of diminishing
or adversely affecting in any material respect the rights and privileges
available to APOTHECON hereunder or which would have the effect of diminishing
or adversely affecting in any material respect GJT's agreements or obligations
hereunder, without the prior written consent of APOTHECON.
ARTICLE 3
GRANT OF LICENSE; BACK-UP SUPPLY; CONSENT AND WAIVER
3.1 Grant of License. [Intentionally omitted].
3.2 Manufacture and Supply of Product.
3.2.1 Subject to the terms of this Agreement, and where referenced the
* License Agreement, APOTHECON will arrange, through itself and/or its
Affiliate(s) and/or a Third Party, to manufacture and supply the
Product needed for GJT to conduct all testing and other activities
contemplated by or through it under the Development Program (and
section 4.6 hereof) or needed to register the Product in a given
country. APOTHECON will also be responsible for arranging and
coordinating, either through itself or its Affiliates or through a
Third Party, for the supply of the Product as will be used for all
other commercial purposes, and for procuring and supplying the raw
material to make the Product (other than raw material previously
purchased by GJT for the Development Program).
3.2.2.1 GJT shall remain solely responsible to APOTHECON (whether or
not delegated by GJT) for all matters relating to GJT's
responsibilities hereunder, including without limitation the
following matters: bioequivalence and clinical testing;
transfer and training in the use of the GEOMATRIX Technology
by APOTHECON, its Affiliates, and any contract or back-up
supply manufacturer selected by APOTHECON; and prompt and
complete training and consulting assistance in the use of the
GEOMATRIX Technology so that APOTHECON may, through itself
and/or its Affiliates or a Third Party, initiate and complete
Scale-Up (including Validated Manufacturing Scale-Up) on a
timely basis.
3.2.2.2 As soon as reasonably practicable after the date of the
Agreement, and from time to time thereafter during the term
hereof as additional information becomes available, GJT shall
provide, and/or shall cause its Affiliates to provide, to
APOTHECON (and any contract and/or back-up supply
manufacturer(s) designated by APOTHECON in accordance with
this Agreement and, where referenced, the * License Agreement)
with all Know-How, information regarding the Patent Rights,
technical assistance and such other
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cooperation as may be reasonably requested by APOTHECON and
is available from GJT from time to time hereunder to enable
APOTHECON (and any such contract and/or back-up supply
manufacturer(s) designated by APOTHECON) to obtain all
regulatory approvals required (i) to effect Scale-Up
(including Validated Manufacturing Scale-Up), (ii) to
qualify, file and obtain registration as a manufacturer and
supplier (or back-up supplier, as the case may be) of the
Product, and (iii) to make and/or have made Products in
accordance with the terms of this Agreement and applicable
regulatory filings therefor. Additionally, GJT shall make its
and/or its Affiliates' employees and consultants available
for consultation, at such time and place as APOTHECON (and
any such contract and/or back-up supply manufacturer(s)
designated by APOTHECON) reasonably requests, regarding the
scale-up and manufacture of Products. Technical assistance
supplied by GJT and/or its Affiliates for such purposes shall
be without additional charge for such services to APOTHECON
(and any such contract and/or back-up supply manufacturer
designated by APOTHECON), except to the extent reimbursement
for such charge is already included within the budgets
pursuant to section 4.6 hereof, and provided that APOTHECON
will reimburse GJT and/or its Affiliates for any reasonable *
incurred by GJT or its Affiliates in connection therewith not
covered by such budgets and for any other reasonable *
(including *) needed to train an entity (other than APOTHECON
and one unAffiliated Third Party selected by APOTHECON as a
contract or back-up supplier) in the use of the GEOMATRIX
technology.
3.3 Other Suppliers. [Intentionally omitted.]
3.4 Initiation of Back-up Supply. [Intentionally omitted.]
3.5 Sublicenses to Certain Third Parties. [Intentionally omitted].
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 and
thereafter as it becomes available during the term of this Agreement, each party
agrees, subject to conflicting third party rights, to promptly furnish the other
in writing all technical information and pre-clinical and clinical data
developed or acquired relating to the Product that comes into 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, provided, that the foregoing shall not be construed as
covering, or requiring APOTHECON to disclose, any manufacturing know-how or
trade secrets (including but not limited to procedures, techniques, and
processes) of APOTHECON, its Affiliates or its contract suppliers. All such
information exchanged shall be treated as Confidential Information of the
disclosing party.
4.2 Product Specifications. The parties agree to target, and
acknowledge that the costs of Product development set forth in section 4.6 below
contemplate, the development of the Product *. The parties may in their
discretion determine hereafter to pursue different or additional strengths for
the Product, in which event the parties will negotiate mutually acceptable terms
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and conditions for the development and marketing of same, with such terms to be
similar, where practicable, to the terms and conditions contained herein, it
being further understood that APOTHECON will fund the costs to develop and
register any such additional strengths.
The dosage strength, formulation, quality and other specifications
("Specifications") of the furnished Product shall depend in relevant part on the
following items:
i) Conformity to current USP monograph(s) for all pertinent
inactive and active ingredients;
ii) election of dosage strength and formulation (the parties
agreeing initially to target *, and to determine hereafter
(based upon estimates of the cost of development thereof)
whether also to pursue development of *); and
iii) GMP-related specifications resulting from GJT's Product
validation.
The parties shall jointly agree upon and memorialize in writing the
Specifications for the Product at the earliest practicable time; the initial
Specifications are attached as Exhibit 4.2 hereto. Hereafter, changes or
supplements to the Specifications may be made only by mutual written agreement.
4.3 APOTHECON Product Development Duties. Subject to section 6.2 of the
* License Agreement, APOTHECON will, at its expense, use commercially reasonable
efforts to prepare or have prepared (by itself or through an Affiliate) the
necessary documentation, and shall take or have taken all necessary actions, to
obtain and maintain all Registrations (e.g., the ANDA in the United States) in
its name for the marketing of the Product during the term of this Agreement in
those countries in the Territory in which, and for so long as, APOTHECON in its
discretion considers it commercially feasible to do so. APOTHECON shall use
commercially reasonable efforts to complete such Registrations in its own name
(or in the name of an Affiliate, if APOTHECON believes that such Registration
would be better effected by an Affiliate in such country) as quickly as
commercially feasible. GJT will have the right to review and comment on all such
regulatory applications and other submissions prior to filing, and APOTHECON (or
such Affiliate) will give due consideration to any reasonable requests of GJT.
APOTHECON shall inform GJT promptly in writing on any unforseen material
problems, delays or requirements in connection with such Registrations.
APOTHECON (or such Affiliate) shall maintain such Registrations for the Product
in each country in the Territory in which the Product is sold during the term of
this Agreement, or such portion thereof as APOTHECON (or an Affiliate) is
selling the Product in such country, and thereafter for such period as required
by applicable law or regulation. APOTHECON (or such Affiliate) will be
responsible for all costs incurred by it in connection with filing and
maintaining such Registrations.
GJT shall, or shall cause its Affiliates, Subcontractees and licensors
of the GEOMATRIX Technology to, provide such advice and technical assistance as
APOTHECON (or its Affiliates) may reasonably request in order to prepare, obtain
and maintain such Registrations. APOTHECON (and any pertinent Affiliate) will
have the right to review, copy, access, cross-reference and use all development,
manufacturing and testing information obtained or developed by any of them as
APOTHECON (or such Affiliate) reasonably considers necessary to obtain such
Registrations. All material provided by GJT toward that end will be held in
confidence (subject to regulatory and filing requirements) under Article 10
hereof.
APOTHECON shall be responsible for all costs incurred by it in
connection with such Registrations. GJT shall be responsible for any costs
incurred by it in connection with assisting APOTHECON to obtain and maintain
same, to the extent not subsumed within the payments contemplated by section 4.6
hereof.
4.4 GJT Product Development Duties. Subject to Article 4.7:
4.4.1 GJT will use commercially reasonable efforts to conduct or have
conducted such research, formulation, development, testing, and
preclinical and human clinical trials and bioequivalence testing as are
necessary or desirable to obtain all required Registrations for the
Product in those countries in the Territory selected for
commercialization by APOTHECON, in accordance with the terms of this
Agreement
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and the Development Program. GJT shall conduct or have conducted such
activities in a diligent and efficient manner and in compliance in all
material respects with all applicable governmental and legal
requirements, all applicable good laboratory and clinical practices,
and all applicable standards of practice established by applicable
regulatory authorities. GJT shall allocate all necessary resources,
including without limitation facilities, equipment, time and use of
personnel with sufficient skills and experience, to perform and
accomplish its development obligations hereunder.
4.4.2 GJT will use commercially reasonable efforts to complete all
bioequivalence testing and all pivotal clinical studies, and to assist
APOTHECON in completing and demonstrating Validated Manufacturing
Scale-Up, for the Product by *.
4.5 Development and Registration Reports. In addition to such other
informal reports and meetings as the parties may mutually agree to conduct, each
party shall inform the other of all material activities and results regarding
its development and Registration of the Product, as follows:
4.5.1 Within * during the term of the Agreement (or more frequently as
APOTHECON may request), GJT shall prepare and deliver to APOTHECON a
written summary report which shall describe, with respect to each
Product, the status of such research, development, and clinical trials
and such Registrations. Not less than * to the commencement of any
human clinical trials of the Product, GJT shall provide APOTHECON with
a reasonably detailed written report summarizing such proposed human
clinical trials.
4.5.2 Not less than * to the filing or submission by APOTHECON of any
regulatory filing or submission to an applicable regulatory authority
regarding Registration to market the Product, APOTHECON shall provide
GJT with a reasonably detailed written report summarizing such proposed
regulatory filing or submission.
4.5.3 Each party shall provide the other with prompt notice of all
regulatory filings and submissions to, and all responses and approvals
obtained from, regulatory authorities regarding any Registration sought
by a Party for the Product. Upon written request by the other party, a
copy of any filing and submission made by a party to a regulatory
authority, as well as the regulatory authority's written response
thereto, shall be provided to the requesting party.
4.6 Development Cost Funding. Subject to section 4.7:
4.6.1 * shall be responsible for * incurred by *, after July 1, 1995,
in the formulation, development and testing of the Product in the
Territory, * as provided below. GJT will be responsible for all
research and development costs in excess of such amounts that may be
incurred by it or its Subcontractees in connection therewith, other
than * associated with the conduct of pivotal clinical trials for which
* shall be responsible. GJT has estimated, based upon currently
available information and in recognition of incomplete regulatory
guidance available at this time, that its external costs associated
with the conduct of such pivotal clinical studies will be in the range
of *, it being further understood that if actual costs are different
(including materially different) from such estimate, GJT shall not be
considered to have breached this Agreement by reason of such
difference, unless GJT's estimate was made in bad faith.
GJT's reasonable and actual Research and Development Costs will be
reimbursed by APOTHECON subject to section 4.6.2 and pursuant to the
following budget and milestones, as follows:
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* Confidential treatment requested. The redacted material has been separately
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GJT will provide * to APOTHECON of actual Research and Development
Costs expended by GJT under the budget for each milestone established
below. When an advance against the full budget for a milestone has been
fully expended, APOTHECON will thereafter reimburse GJT for its
reasonable and actual Research and Development Costs incurred under
such milestone, up to the total amount budgeted for such milestone,
pursuant to such * submitted by GJT; provided, however,
that any individual charges * can be submitted for reimbursement by GJT
separately from the *, APOTHECON will pay same, to the
extent not contested by it in good faith, within thirty (30) days
thereafter.
Upon conclusion of each milestone, GJT will submit a detailed
reconciliation of actual Research and Development Costs incurred by it
under such milestone against budget. Any * by APOTHECON will be *
payments to be made under the succeeding milestone (and against outside
clinical expenses * by it); any excess actual Research and Development
Costs reasonably incurred by * may be * by it against any favorable
budget variance arising under a succeeding milestone or will be
reimbursed by APOTHECON following conclusion of the work under all
milestones against an * reserved by * for same. Should the payments
made by APOTHECON in the aggregate following conclusion of the work
under all milestones exceed the actual direct costs reasonably incurred
by GJT, the difference will be repaid to APOTHECON within 30 days
following ANDA approval.
The budget and payment milestones are as follows:
4.6.1.1 Contract signing/Feasibility Studies. (This includes
formulation development, analytical methods development, and * product
*). The budget for this milestone is * which will be paid upon contract
signing.
4.6.1.2 Initiation of Scale-Up Activities. (This includes raw materials
previously purchased by *, * Scale-Up activities, and analytical
methods validation). The budget for this milestone is * of which will
be paid upon initiation of work for scaling up the manufacturing
processes and analytical methods validation for production of the
bio-batch, and the balance to be paid as provided above in this section
4.6.1.
4.6.1.3 Bio-batch manufacturing. (This includes transfer of methods and
GEOMATRIX technology. Actual manufacturing and raw materials purchase
will be handled directly by *, other than raw materials purchase for *
which have previously been purchased by * and will paid for separately
by * pursuant to section 4.6.1.2). The budget for this milestone is *
of which will be paid upon initiation of work for manufacture of the
bio-batch, and the balance to be paid as provided above in this section
4.6.1.
4.6.1.4 Clinical studies and laboratory trials. (This includes
preparation, initiation and completion of all clinical trials,
compilation of data for * section, and stability testing). The budget
for this milestone * exclusive of GJT's external costs to Third Parties
associated with the conduct of such pivotal clinical studies. * will be
paid upon initiation of work for the commencement and completion of the
pivotal clinical trials, and the balance to be paid as provided above
in this section 4.6.1.
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* Confidential treatment requested. The redacted material has been separately
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4.6.1.4.1 External Clinical Development Costs. GJT will
structure and present for APOTHECON's approval (not to be
unreasonably withheld) the clinical program (including
protocols and selection of Third Parties serving as CROs or
otherwise providing clinical services) required for Product
testing and approval, as well as the budget therefor
(including all amounts to be paid to such Third Parties for
the clinical work conducted by such Third Parties). GJT will
enter into appropriate agreements with such Third Parties
pursuant to Section 4.7, and APOTHECON will either reimburse
GJT for (or will pay directly to such Third Party) all amounts
actually paid (or owed) by GJT to such Third Parties for the
performance of such services in accordance with such budget(s)
and time lines therefor (and as the same may be changed,
supplemented or extended by mutual written agreement
thereafter), or, if not so budgeted, within 30 days after
presentation of an invoice and substantiating documentation by
GJT (to the extent not contested in good faith). GJT will
endeavor to structure such clinical program in a reasonably
cost-effective manner consistent with the time lines set forth
herein.
4.6.1.5 ANDA preparation. (This includes compilation of ANDA
and related assistance). The budget for this milestone * of
which will be paid upon initiation of this milestone, and the
balance to be paid as provided above in this section 4.6.1.
4.6.2 GJT will present the overall development budget for review,
comment and approval by APOTHECON. The parties will jointly determine
specific benchmarks to monitor the process of development. APOTHECON
will have the right to review and comment on all significant
development and testing activities prior to the start of these
activities and GJT will give due consideration to all reasonable
comments and requests made by APOTHECON. GJT will give APOTHECON a
reasonable period in which to conduct such review, and APOTHECON will
conduct its review and provide its comments within such reasonable
period, so as not to cause any undue delay in the commencement of such
activities. Upon conclusion of each of the milestones under 4.6.1.1,
4.6.1.2, 4.6.1.3, and 4.6.1.4 (and any other specific
benchmarks/milestones to which the parties may mutually agree) and
before proceeding to the next milestone, GJT must first receive
APOTHECON's written approval (not to be unreasonably withheld).
4.6.3 GJT will provide APOTHECON, at its request, with a *
reconciliation of actual Research and Development Costs of development
hereunder incurred against budget where the duration of, or costs
incurred against, a milestone is a period longer than *.
4.7 Consent and Waiver - Conforming Changes.
4.7.1 Notwithstanding any provision in this Agreement or in the
GEOMATRIX Research and Development Agreement to the contrary, and
subject to Article 11 hereof:
4.7.1.1 All applications filed by GJT or any other party to
the GEOMATRIX Research and Development Agreement
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.
4.7.1.2 All data and results pertaining to the Product
generated by any party to the Research and
Development Agreement shall be owned solely by
APOTHECON. Concurrently with the execution and
delivery of this Agreement, GJT will turn over to
APOTHECON all data and results heretofore developed
by or for it pertaining to the Product. GJT will
thereafter report to APOTHECON in writing such data
and results developed by or for it not less
frequently than quarterly (monthly, if requested by
APOTHECON) and will transmit all such data to
APOTHECON by magnetic media or such other method as
APOTHECON may request.
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* Confidential treatment requested. The redacted material has been separately
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4.7.1.3 In the event that the GEOMATRIX Research and
Development Agreement should terminate, for whatever
reason and however effected, APOTHECON shall be
entitled, but shall not be obligated, to enter into
an agreement with any of the parties to said
GEOMATRIX Research and Development Agreement for the
development and registration of the Product on terms
and conditions acceptable to APOTHECON (and with
APOTHECON having the rights that GJT otherwise would
have 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 this Agreement).
4.7.2 GJT shall submit to APOTHECON a copy of (i) all reports,
statements, invoices, Product workplans, and budgets submitted to it by
any party to the GEOMATRIX Research and Development Agreement 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. If GJT should default in its obligations under the
GEOMATRIX Research and Development Agreement, 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
each party to the GEOMATRIX Research and Development Agreement (other
than GJT) 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 owed by APOTHECON to
GJT under section 4.6 hereof (or, to the extent no such sums remain
owing by APOTHECON under said section 4.6, then against such amounts as
may be owed by APOTHECON under section 7.1 of the * License Agreement).
4.7.3 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.
4.7.4 GJT shall defend, indemnify and hold APOTHECON 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 its directors, officers, general partners,
employees, consultants, or agents. 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").
ARTICLE 5
MANUFACTURE AND SUPPLY OF PRODUCT
5.1 Manufacture. APOTHECON shall manufacture or have manufactured
Products for all clinical and commercial purposes in accordance with prevailing
industry standards and in compliance in all material respects with all
applicable laws, regulations and other governmental requirements, all applicable
good manufacturing practices and all applicable standards of practice
established by applicable regulatory authorities. Without limiting the
generality of the foregoing, Product manufactured in the United States shall be
manufactured in accordance with CGMPs promulgated by the FDA and pursuant to all
necessary DMFs filed with FDA. APOTHECON shall be responsible for all costs of
any nature incurred by or on behalf of it in connection with the manufacture of
the Product.
5.2 Product Registrations.
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5.2.1 APOTHECON shall prepare or have prepared, on behalf of itself, an
Affiliate and/or a Third Party contract or back-up manufacturer, the
necessary documentation, and shall take or have taken all necessary
actions, to obtain and maintain Registrations for the manufacture of
Products needed to meet APOTHECON's reasonably foreseeable requirements
for same. APOTHECON shall use commercially reasonable efforts to
complete such Registrations as quickly as commercially feasible.
APOTHECON shall inform GJT promptly in writing on any unforseen
material problems, delays or requirements in connection with such
Registrations. APOTHECON and/or such other contractor back-up
manufacturer shall maintain such Registrations for the Product in each
country in which the Product is manufactured during the term of the
Agreement, or such portion thereof as the Product is manufactured in
such country, and thereafter for such period as required by applicable
law or regulation. APOTHECON shall be responsible for all costs
incurred by it or on its behalf in connection with such Registrations.
Without limiting the generality of the foregoing, APOTHECON will use
commercially reasonable efforts:
to pursue all necessary DMF approvals required in the
United States (and corresponding approvals, where applicable,
in other countries in the Territory) for all pertinent bulk
and/or finished material components of the Product and will
cooperate with and comply with all reasonable requests of
applicable governmental authorities in pursuit of same; and
to secure necessary approvals from applicable
governmental authorities for the manufacturing facilities from
which finished dosage form Product will be supplied and shall
cooperate with such applicable governmental authorities and
comply with their reasonable requests for site inspections and
other information and analyses in pursuit of the approved ANDA
and any other Registrations.
5.3 Manufacturing and Registration Reports. APOTHECON shall inform GJT
of the following activities regarding the manufacture of the Product, as
follows:
5.3.1 Within * days following the end of each * until ANDA approval,
APOTHECON shall prepare and deliver to GJT a written summary report
which shall describe, with respect to the Product, material information
pertaining to its manufacturing status; provided, that any proprietary
or confidential information of APOTHECON and its Affiliates, such as
manufacturing know-how or trade secrets, shall not be required to be
disclosed and may be redacted.
5.3.2 APOTHECON shall provide GJT with prompt notice of all regulatory
filings and submissions to, and all responses and approvals obtained
from, regulatory authorities regarding such Registration to manufacture
of the Product.
5.3.3 Each party shall promptly advise the other of any safety or
toxicity problem of which either party becomes aware regarding the
Product, intermediates or other ingredients or processes used in the
manufacture of the Product.
5.3.4 APOTHECON shall be responsible for ongoing stability testing with
respect to Product.
5.4 Product Purchase.
5.4.1 Subject to Article 11 hereof and to Section 3.2 hereof, the
parties agree to cooperate to ensure an orderly and timely supply of
Product to GJT and its clinical investigators of all Product required
by GJT to conduct pivotal clinical studies and bioequivalence testing
and to establish a reasonable procedure for ensuring that APOTHECON
receives adequate advance notice of GJT's requirements for same. All
Product supplied by APOTHECON shall be sold F.O.B. GJT's (or its
clinical investigator's) facility (as the case may be), and title to,
and risk of loss, of the Product shall pass upon delivery to such
facility.
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5.4.2 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.
5.5 Acceptance; Rejection of Product in Case of Non-Conformity.
5.5.1 GJT may reject the shipment to it or its investigators of
Product, in whole or in part, if adulterated or otherwise not
conforming in any respect with the Specifications. In order to reject a
shipment, GJT must give written notice to APOTHECON within * after
receipt of the shipment, together with a reasonably detailed statement
of its reasons for rejection, and a report of its analysis of the
allegedly nonconforming Product, together with the methods and
procedures used. If no such notice is received, then GJT shall be
deemed to have accepted the shipment of the Product, unless such
nonconformity or grounds for rejection could not reasonably have been
discovered by GJT (pursuant to the procedures set forth in the
Specifications) within such * period, in which event the commencement
of said * period shall be tolled until such nonconformity or grounds
are discovered by GJT. APOTHECON shall notify GJT as promptly as
reasonably possible, but in any event within * after receipt of such
notice of rejection, whether it accepts GJT's assertions of
nonconformity.
5.5.2 Whether or not APOTHECON accepts GJT's assertion of
nonconformity, promptly on receipt of a notice of rejection, APOTHECON
shall use its best efforts provide replacement of the same Product as
in the original shipment. If the original shipment ultimately is found
to be nonconforming, APOTHECON shall bear its own expenses of such
replacement; if the original shipment is ultimately found to be
conforming, GJT shall bear the cost of such replacement and shall
reimburse APOTHECON, within * following demand for same, for all
reasonable expenses and costs incurred by APOTHECON in connection with
the manufacture and shipment of such replacement Product.
5.5.3 If APOTHECON disagrees with any alleged nonconformity to the
Specifications, then the parties will use their best efforts to resolve
the disagreement promptly as follows: an independent GMP laboratory (or
other consultant), acceptable to both GJT and APOTHECON, shall analyze
an aliquot sample or such other portions of the shipment, furnished by
GJT from the shipment received by GJT, as may be necessary to
substantiate whether the Product rejected by GJT conformed (or not) to
the pertinent Specifications. The laboratory shall use such procedures
and tests as the laboratory may consider necessary to reach a
conclusion; however, if, by using the same tests set forth in the
Specifications as were used by GJT, such laboratory confirms GJT's
findings, further tests shall not be required. Both parties agree to
cooperate with the independent laboratory's reasonable requests for
assistance in connection with its analysis hereunder. Both parties
shall be bound by the laboratory's results of analysis. The costs
incurred by the laboratory shall be borne by the losing party.
5.5.4 If APOTHECON or the independent laboratory confirms the
nonconformity, then, in addition to any other remedies set forth
herein, at law or in equity, APOTHECON shall replace (if it has not
already done so) the nonconforming Product with conforming Product as
promptly as possible. Replacement shipments shall also be subject to
the procedures contained in this Section 5.5. If the independent
laboratory confirms (or GJT subsequently agrees) that no nonconformity
existed, then, in addition to any other remedies set forth herein or
available at law or in equity, GJT shall pay for the cost of the
replacement shipment.
5.5.5 Unless APOTHECON requests the return to it of any nonconforming
Product, GJT shall lawfully destroy such Product promptly and provide
APOTHECON with written certification of such destruction. GJT shall,
upon receipt of APOTHECON's request for return, promptly dispatch said
Product to APOTHECON, at APOTHECON's expense.
5.6 Process Changes. [Intentionally omitted.]
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5.7 Warranties.
5.7.1 APOTHECON represents and warrants to GJT that Product delivered
by or through APOTHECON to GJT shall, at time of delivery to GJT (or to
a clinical or laboratory site, as the case may be), conform with
Product Specifications and be in compliance in all material respects
with applicable laws, regulations and other governmental requirements
and with all applicable Regulatory requirements and approvals,
including without limitation that such Product shall not be adulterated
within the meaning of the Federal Food, Drug and Cosmetic Act, as
amended, or within the meaning of any applicable state or municipal law
in which the definition of adulteration is substantially the same as
that contained in the Federal Food, Drug and Cosmetic Act, as such Act
and such laws are constituted and effective at the time of delivery.
5.7.2 APOTHECON further represents and warrants that such samples and
batches intended for clinical or bioequivalence testing will be
manufactured in accordance with the regulations of the appropriate
regulatory authority of the country (e.g., CGMP in the United States)
in which the Product is manufactured.
5.7.3 APOTHECON represents and warrants that the quality control
procedures and in-plant quality control checks on the manufacture of
Product shall be applied in the same manner as those procedures and
checks are applied to other products manufactured for sale by APOTHECON
or its contract manufacturer.
5.7.4 NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, OTHER THAN THOSE EXPRESSLY MADE IN THIS AGREEMENT OR THE *
LICENSE AGREEMENT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE (AND INCLUDING ANY EXPRESS OR IMPLIED
WARRANTY THAT THE MANUFACTURE, USE OR SALE OF THE PRODUCT INFRINGES OR
WILL INFRINGE ANY PATENT RIGHTS OR TRADEMARK RIGHTS OWNED OR CONTROLLED
BY ANY PERSON OTHER THAN A PARTY OR ITS AFFILIATES) ARE HEREBY
DISCLAIMED BY EACH PARTY.
5.8 Inspection. [Intentionally omitted].
5.9 [Intentionally omitted.]
5.10 Payment Terms. APOTHECON will provide Product reasonably required
by GJT for bioequivalence and clinical testing in accordance with the procedures
set forth in Section 4.6 hereof without charge, and will pay for any shipping,
packaging and insurance costs, as well as any customs and import charges
incurred by GJT or its clinical investigators, associated with such shipments of
Product.
ARTICLE 6
MARKETING
6.1 Packaging and Labeling. APOTHECON shall be responsible at its
expense for arranging for the labeling and packaging into bottles (or otherwise)
the finished * form of the Product. GJT shall have the right to review and
comment on all labels and labeling prior to any final Regulatory approval
required of same.
6.2 Commercialization. Intentionally omitted].
6.3 Covenant Not to License a Competitor. So long as APOTHECON retains
the exclusive rights under section 3.1.2 of the * License Agreement to use,
distribute, market and sell the Product in a country, GJT and its Affiliates may
not (and GJT will cause its Affiliates not to), without the prior written
consent of APOTHECON, use, distribute, develop, market, or sell, or license or
permit any Third Party to use, distribute,
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develop, market, or sell, any other pharmaceutical composition containing *
(including all commonly used and known salts and acids thereof) as
(i) an * in any country, or
(ii) a * in the United States,
and which incorporates, is based on and is derived by use of the GEOMATRIX
Technology, irrespective of whether the dosage, formulation, strength,
specifications or other qualities of such other Product are the same or
different from that being developed, used, distributed, marketed or sold by
APOTHECON.
6.4 Adverse Drug Reactions. The following provisions shall apply to the
reporting of Adverse Drug Reactions:
6.4.1 It will be APOTHECON's responsibility to report ADRs to the FDA;
however, it will be solely GJT's responsibility to report ADRs required
to be reported that arise during clinical testing and which are
otherwise required of GJT in accordance with applicable law.
6.4.2 Each party agrees to furnish party, as hereinafter provided, with
information pertaining to any ADR known to such party from any source
whatsoever (other than from the other party). For such purposes, each
party shall be charged with knowledge of an ADR if (and only if) such
ADR has in fact been brought to the attention of the party. Each party
will exercise due diligence and exert reasonable efforts to collect ADR
information from its affiliates and other related parties worldwide. In
the case of a serious ADR, the party in question shall report to the
other party, in English, within 48 hours of knowledge of the ADR. All
other ADRs shall be reported by the party in question from time to
time, but not less frequently than monthly, in the same manner.
6.4.3 Each party shall maintain, in accordance with its own customary
practice, appropriate detailed records of all ADR reports which have
been submitted to the other party. Further, in the event that either
party shall be requested for more detailed investigation by the U.S.
Food and Drug Administration or other regulatory body on any ADR, such
other party shall cooperate and assist the party in question with
respect to such investigation.
6.4.4 Each party further shall immediately notify the other of any
information received regarding any threatened or pending action by a
regulatory agency which may affect the safety and efficacy claims of
the Product. Upon receipt of any such information, the parties shall
consult with each other in an effort to arrive at a mutually acceptable
procedure for taking appropriate action; provided, however, that
nothing contained herein shall be construed as restricting either
party's right to make a timely report of such matter to any regulatory
agency or take other action that it deems to be appropriate or
required, by applicable law or regulation.
6.4.5 The obligations under this Section 6.4 shall survive for the
period of time that such reporting obligations exist under applicable
law.
6.5 Product Recall
6.5.1 In the event (a) any government authority of a country in the
Territory in which APOTHECON or any of its Affiliates markets or
marketed the Product should issue a request, directive or order that
Product be recalled, or (b) a court of competent jurisdiction orders
such a recall, or (c) the parties reasonably determine after
consultation with each other that Product should be recalled
("Recall"), the parties shall take all appropriate corrective action.
6.5.2 APOTHECON shall be responsible for the expense of a Recall,
except to the extent that a Recall and any related expenses are
attributable to a cause or event or instruction by GJT or its
Affiliates, in
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* Confidential treatment requested. The redacted material has been separately
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which case GJT shall be responsible for same. For purposes of this
Agreement, Recall expenses shall include, but not be limited to, the
expenses of notification and destruction or return of the recalled
Product, as the case may be, and APOTHECON's and GJT's costs for the
recalled Product, as the case may be; provided, however, the expense or
service fee associated with representatives' time of a party hereto (or
of its Affiliates) shall be borne by such party.
6.5.3 In the event a Recall resulting from any cause or event arising
from a cause or event or instruction attributable to GJT, APOTHECON
shall have the right at any time within of such Recall to terminate
this Agreement.
ARTICLE 7
MILESTONE AND ROYALTY PAYMENTS
[Intentionally omitted].
ARTICLE 8
PATENT RIGHTS
8.1 Patent Prosecution and Maintenance. GJT shall be responsible for
and shall control, at its sole cost, the preparation, filing, prosecution and
maintenance of all patent applications and patents of the Patent Rights. In so
doing, GJT shall endeavor to obtain the strongest commercially reasonable patent
protection (under the circumstances) regarding the GEOMATRIX Technology with
respect to the Product and shall consider in good faith the interests of
APOTHECON. With respect to Patent Rights pertaining to the Product in those
countries in which APOTHECON has the right hereunder to market the Product: GJT
(a) shall supply APOTHECON with a copy of each such patent application as filed,
together with notice of its filing date and serial number; (b) shall consult
with APOTHECON regarding the prosecution and maintenance of such Patent Rights
relating to the Product, and shall implement all reasonable requests of
APOTHECON with respect thereto; (c) shall inform APOTHECON promptly of any
substantive action or proposed action with respect to the Patent Rights relating
to the Product, shall provide APOTHECON with advance copies of all proposed
responses thereto, and shall implement all reasonable requests of APOTHECON with
respect thereto; (d) shall not abandon or materially narrow the substantive
claims of the Patent Rights without the prior express written consent of
APOTHECON; (e) shall provide APOTHECON with copies of all filings, submissions,
together with all correspondence, with the applicable patent authorities
regarding the Patent Rights; (f) shall inform APOTHECON promptly of the
allowance and issuance of each patent included in the Patent Rights, together
with the date and patent number thereof, and shall provide APOTHECON with a copy
of such patent as issued; and (g) shall prosecute all reexaminations and
reissues as reasonably requested by APOTHECON. APOTHECON shall cooperate with
GJT, execute all lawful papers and instruments and make all rightful oaths and
declarations as may be necessary in the preparation, prosecution and maintenance
of all such patents and patent applications.
8.2 Notification of Infringement. Each party shall notify the other
party of any infringement of the Patent Rights with respect to Products that
comes to the attention of the management of such party and shall provide the
other party with the available evidence, if any, of such infringement.
8.3 Enforcement of Patent Rights. With respect to Patent Rights
pertaining to those countries in which APOTHECON has the exclusive right
hereunder to market the Product, APOTHECON, at its sole expense, shall have the
right, but not the obligation, (a) to determine the appropriate course of action
to enforce, or otherwise xxxxx the infringement of, the Patent Rights with
respect to Products, (b) to take, or refrain from taking, appropriate action to
enforce the Patent Rights with respect to Products, (c) to control any
litigation or other enforcement action regarding Patent Rights with respect to
Products, and (d) to enter into, or permit, the settlement of any such
litigation or other enforcement action regarding Patent Rights with respect to
Products. APOTHECON shall consult with GJT and Jagotec prior to and during the
course of taking any of the foregoing actions, shall consider, in good faith,
the interests of GJT and Jagotec in taking any of the foregoing actions, and, if
GJT or Jagotec reasonably
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concludes that taking any specific action(s) likely would have a material
adverse effect on GJT's or Jagotec's interests in the Patent Rights (other than
with respect to the Products), and timely gives APOTHECON prior express written
notice thereof, then APOTHECON shall not take such specific action(s) without
the prior express written consent (not to be unreasonably withheld or delayed)
of GJT or Jagotec, as the case may be. If (x) within * after receipt by
APOTHECON of notice by a Third Party pursuant to 21 U.S.C. ss.355(b)(3)(A) or
(j)(4)(B)(iii) with respect to any Product, APOTHECON has not initiated an
action for patent infringement against the Third Party that forwarded such
notice, then GJT and/or Jagotec shall have the right to initiate and control
such action, and (y) within * days after receipt of notice from GJT or Jagotec
of such an infringement, APOTHECON has not taken action to xxxxx the
infringement or filed suit to enforce the Patent Rights with respect to Products
against at least one infringing party, GJT or Jagotec shall have the right to
take whatever action it deems appropriate to enforce the Patent Rights against
such parties in such countries as APOTHECON may have elected not to take action
to xxxxx, or file suit to prevent, such infringement; provided, however, that
GJT or Jagotec, as the case may be, shall have given prompt written notice to
APOTHECON of its intent to file a suit or commence any other enforcement action
in connection therewith. If GJT or Jagotec elects to file such suit or commence
such action, then GJT or Jagotec (as the case may be) shall consult with
APOTHECON prior to and during the course of taking any of the foregoing actions,
and shall consider, in good faith, the interests of APOTHECON in taking any of
the foregoing actions. Within * after receipt of such notice from GJT or Jagotec
(as the case may be), APOTHECON shall have the right to jointly prosecute such
suit or other action and *. The party controlling any such suit or other action
shall not settle the suit or action or otherwise consent to an adverse judgment
in such suit or action that diminishes the rights of the non-controlling party
without the prior express written consent of the noncontrolling party. All
monies recovered upon the final judgment or settlement of any such suit or other
action shall be shared, after reimbursement of expenses of the controlling
party(ies), as follows:
i) Where APOTHECON has solely controlled the litigation, * shall
be entitled to retain all monies recovered and awarded upon
the final judgment or settlement of any such suit or other
proceeding, and shall pay to * such amount as equals the *
that * would otherwise have received under the * License
Agreement on * as were taken into account in determining the
monies recovered.
ii) Where control of the litigation has operated other than
pursuant to (i), the parties shall and awarded upon the final
judgment or settlement of any such suit or other proceeding in
proportion to their respective contributions to the cost
thereof.
Notwithstanding the foregoing, APOTHECON, Jagotec, and GJT shall
reasonably cooperate with each other in the planning and execution of
any suit or other action to enforce the Patent Rights with respect to
Products.
8.4 Third Party Infringement Actions.
8.4.1 If GJT or APOTHECON, or their respective Affiliates or
sublicensees, shall be sued by a Third Party for infringement of a
patent because of the manufacture, use or sale of any pharmaceutical
composition which incorporates, is based on, uses or is derived by use
of the GEOMATRIX Technology, the party which (or whose Affiliate) has
been sued shall promptly notify the other party in writing of the
institution of such suit, and with respect to suits which are the
subject of Section 8.4.2 below, shall provide the other party with
copies of all pleadings, exhibits and all other relevant information
available to such other party regarding such pleadings.
8.4.2 If the suit alleges the infringement of a patent because of the
use or sale of the Product (or an intermediate in the manufacture
thereof) and the alleged infringing process, method or composition is
claimed under the Patent Rights, APOTHECON shall have the right, in its
sole discretion, to control the defense of such suit with counsel of
its own selection and at its own expense; provided, however, that GJT
or, if GJT elects not to exercise its option, Jagotec shall have the
option, within * after receipt of notice of any such suit, to
co-control the defense of such suit. If GJT or Jagotec timely exercises
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its option to co-control the defense of such suit, (a) APOTHECON and
GJT (or Jagotec, as the case maybe) shall select mutually-acceptable
counsel, if possible, and GJT or Jagotec, as the case may be, shall be
solely responsible for paying the fees and costs of its own advisory
counsel of its own selection and the fees and costs of any party hereto
in taking any action in such suit at the request of GJT or Jagotec (as
the case may be) or any action to defend the rights or interests of GJT
or Jagotec, but not the interests APOTHECON, or (b) if APOTHECON and
GJT (or Jagotec, as the case may be) are unable to select
mutually-acceptable counsel, APOTHECON and GJT (or Jagotec, as the case
may be) each shall be represented in the defense of such suit by
counsel of its own selection at its own expense. If GJT (or Jagotec, as
the case may be) fails to timely exercise its option to co-control the
defense of such suit, GJT and Jagotec shall have the right to be
represented by advisory counsel of their own selection and at their own
expense, shall cooperate fully in the defense of such suit and shall
furnish to APOTHECON all evidence and assistance in its control. If
APOTHECON does not elect, within * after receipt of notice of any such
suit, to control the defense of such suit, GJT or Jagotec may undertake
such control of the defense of such suit with counsel of its own
selection and at its own expense. In such case, APOTHECON shall have
the right to be represented by advisory counsel of its own selection
and at its own expense, shall cooperate fully in the defense of such
suit and shall furnish to GJT or Jagotec (as the case may be) all
evidence and assistance in its control.
8.4.3 If the suit alleges the infringement of a patent because of the
use or sale of a pharmaceutical composition which incorporates, is
based on, uses or is derived by use of the GEOMATRIX Technology, which
is not the Product (or an intermediate in the manufacture thereof), and
the alleged infringing process, method or composition is claimed under
the Patent Rights, GJT or, if GJT declines to exercise same, Jagotec,
shall have the right, in its sole discretion, to control the defense of
such suit with counsel of its own selection and at its own expense. In
such case, GJT (or Jagotec, as the case may be) shall inform APOTHECON
from time to time, and upon the reasonable request of APOTHECON, of the
status of the defense or settlement of any such action.
8.4.4 The party controlling such suit shall consult with the
non-controlling party prior to and during the course of such suit, and
shall consider, in good faith, the interests of the non-controlling
party in connection therewith. The party controlling such suit shall
not settle the suit or otherwise consent to an adverse judgment in such
suit that diminishes the rights or interests of the non-controlling
party without the express written consent of the non-controlling party
( not to be unreasonably withheld or delayed). All judgments,
settlements or damages payable with respect to any suit covered by this
Section 8.4 shall be paid by the party which controls the litigation,
or if co-controlled, then by both parties. In the event that APOTHECON
controls or co-controls any such claim, it will be entitled to offset
up to of the reasonable costs and expenses (including professional
fees) incurred by it in connection with any such defense against *
under the * License Agreement, up to a * it would otherwise owe to GJT
during any *.
8.4.5 If as a result of a settlement or other outcome under the suit or
other proceedings conducted against a Third Party pursuant to this
section 8.4, or if GJT and APOTHECON jointly agree to seek a license
from a Third Party in order to avoid infringing such Third Party's
patent rights with respect to the manufacture, use or sale of a Product
in a country in the Territory, ongoing royalties or other payments must
be paid by APOTHECON to such Third Party, APOTHECON shall be entitled
to * by it to such Third Party * to * under the * License Agreement
with respect to such country, up to a * to * during any * with respect
to such country.
8.5 Prosecution and Defense of Non-Patent Actions. APOTHECON, with
counsel of its own selection and at its sole expense, shall have the right, but
not the obligation, (a) to control the prosecution of any litigation or other
action with respect to the manufacture, use or sale of Products which is not
described in Section 8.3 above, (b) subject to the provisions of Article 12
below, to control the defense of any litigation or other action with respect to
the use or sale of Products which is not described in Section 8.4 above, and (c)
to enter into, or permit, the settlement of any such litigation or other action
described in clause (a) or (b) above. APOTHECON shall consult
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with GJT and Jagotec prior to and during the course of taking any of the
foregoing actions, and shall consider, in good faith, the interests of GJT and
Jagotec in taking any of the foregoing actions. APOTHECON shall not settle any
such litigation or other action or otherwise consent to an adverse judgment in
such litigation or other action that diminishes the rights or interests of GJT
and Jagotec without the prior express written consent of GJT (not to be
unreasonably withheld or delayed). Notwithstanding the foregoing, GJT and
Jagotec shall fully cooperate with APOTHECON at its request in the planning and
prosecution or defense of any such litigation or other action. After
reimbursement of any reasonable expenses of GJT and Jagotec incurred at the
request of APOTHECON in the planning and prosecution or defense of any such
litigation or other action, * shall be entitled to retain all monies recovered
upon the final judgment or settlement of any such litigation or other action.
APOTHECON shall be responsible for all judgments, settlements or damages payable
with respect to any such litigation or other action covered by this Section 8.5.
8.6 Notification of Patent Term Restoration. GJT shall notify
APOTHECON, and any sublicensee which APOTHECON requests in writing, promptly of
each notice pertaining to any patent included within the Patent Rights which it
(or Jagotec) receives as patent owner pursuant to the Drug Price Competition and
Patent Term Restoration Act of 1984 (the "Act"), including notices pursuant to
21 U.S.C. ss.355(b)(3)(A) or (j)(4)(B)(iii) from persons who have filed an
Abbreviated New Drug Application. GJT shall give all such notices promptly, but
in any event within five (5) calendar days of receipt of each such notice
pursuant to the Act, whichever is applicable. GJT promptly shall notify
APOTHECON of each filing for patent term restoration under the Act, any
allegations of failure to show due diligence and all awards of patent term
restoration (extensions) with respect to the Patent Rights. Likewise, GJT
promptly shall inform APOTHECON of patent extensions and periods of data
exclusivity in the rest of the world regarding any Product.
8.7 Indemnification. Subject to Article 8.4 hereof, GJT shall indemnify
and hold harmless APOTHECON, its Affiliates and its and their directors,
officers, employees and agents from and against any all liabilities, losses,
damages, costs and expenses (including reasonable attorneys' fees and costs of
litigation or arbitration, regardless of outcome) to the extent arising out of
or in connection with any claims or causes of action:
8.7.1 * in a country in the Territory because of the manufacture, use
or sale of the Product (or of an intermediate in the manufacture
thereof) in such country and the alleged infringing process, method or
composition is claimed under the Patent Rights, and/or
8.7.2 asserted by a Third Party to the extent based on the *, or breach
of a * owed to such * or their respective Affiliates.
8.8 Condition Precedent. The exercise of any rights and benefits
afforded to Jagotec under sections 8.3-8.5 hereof are conditioned on the receipt
by APOTHECON and GJT of a letter (or acknowledgment in the form contained on the
signature page of this Agreement) from Jagotec signed by a duly authorized
official of Jagotec stating that Jagotec agrees to be bound by the duties and
obligations imposed on Jagotec under such sections and by sections 6.3, 11.2.4.2
and Article 16 hereof, as well as section 11.2.4.2 of the * License Agreement,
and for which an opinion, reasonably satisfactory to APOTHECON, of counsel to
Jagotec is provided as to the enforceability and validity thereof.
ARTICLE 9
TRADEMARKS
[Intentionally omitted]
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* Confidential treatment requested. The redacted material has been separately
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ARTICLE 10
CONFIDENTIALITY
10.1 Confidential Information. Each party shall use reasonable efforts
(including not less than the same efforts it uses to protect its own
confidential information) to maintain in confidence all information, records and
data of the other party (including samples) disclosed by the other party in
connection with the performance of this Agreement and/or the * License
Agreement, and which is identified as, or acknowledged to be, confidential (the
"Confidential Information"), and shall not use, disclose or grant the use of the
Confidential Information except to its and its Affiliates' directors, officers,
employees, agents, consultants, clinical investigators or other permitted
contractors, to the extent such disclosure is reasonably necessary in connection
with such party's activities as expressly authorized by the Agreement or the *
License Agreement. To the extent that disclosure is so authorized, prior to
disclosure, each party hereto shall assure that each such Person is bound to
hold such Confidential Information in confidence in a manner that is similar to
that set forth herein for such party and not make use of the Confidential
Information for any purpose other than those authorized by this Agreement and/or
the * License Agreement.
10.2 Permitted Disclosures. The obligations of confidentiality and
non-use in Section 10.1 above shall not apply to the extent that (a) the
receiving party (the "Recipient") (i) is required to disclose information by
law, regulation or order of a governmental agency or a court of competent
jurisdiction, or (ii) is required to disclose information to any governmental
agency for purposes of obtaining approval to test or market the Product,
provided in each case that the Recipient shall give the disclosing party written
notice thereof and sufficient opportunity to object to any disclosure or to
request confidential treatment thereof; or (b) the Recipient can demonstrate
that (i) the disclosed information was public knowledge at the time of such
disclosure to the Recipient, or thereafter became public knowledge, other than
as a result of actions of the Recipient, its directors, officers and employees
in violation hereof; (ii) the disclosed information was rightfully known by the
Recipient (as shown by its written records) prior to the date of disclosure to
the Recipient by the disclosing party hereunder; (iii) the disclosed information
was disclosed to the Recipient on an unrestricted basis from a source unrelated
to any party to the Agreement and not under a duty of confidentiality to the
disclosing party; or (iv) the disclosed information was independently developed
by the Recipient without the use of Confidential Information disclosed by the
other party hereto. Notwithstanding any other provision of this Agreement or the
* License Agreement, APOTHECON may disclose Confidential Information of GJT
relating to information developed pursuant to either Agreement to any Third
Party with whom APOTHECON has, or is proposing to enter into, a business
relationship (such as a sublicense hereunder; a merger, consolidation or other
reorganization; an acquisition of a business by APOTHECON or a sale of its
business; or a distribution, agency or sales representative arrangement), as
long as such Third Party has entered into a confidentiality agreement with
APOTHECON and the nature and extent of the disclosure bears a reasonable
relationship to the proposed business relationship.
10.3 Terms of the Agreement. Except as otherwise provided in Section
10.2 above, neither party shall disclose any terms or conditions of this
Agreement or the * License Agreement to any Third Party without the prior
consent of the other party. Notwithstanding the foregoing, prior to the
execution of this Agreement and the * License Agreement, the parties shall agree
upon the substance of information that can be used to describe the terms of this
transaction, and the parties may disclose such information without the other
party's consent.
10.4 Term of Confidentiality. The confidentiality obligations under
this Article 10 shall be effective during the term of this Agreement and for a
period of * after the expiration or earlier termination hereof.
ARTICLE 11
TERM AND TERMINATION
11.1 Terms. 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
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* Confidential treatment requested. The redacted material has been separately
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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 Knowhow 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 *; (ii) all rights and licenses
granted by * hereunder * 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 hereof and 7.1 of the * License Agreement (and the
subsections thereunder), provided that such termination is
exercised with respect to United States; (iv) all
Registrations pertaining to the Product shall be * as to the
affected country(ies) and the * under this Agreement shall be
provided to and thereafter may be * to develop, manufacture
and market the Product; (v) the * License Agreement shall *
with respect to the right to sell the Product in such
country(ies); and (vi) * shall thereafter be entitled 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
sections 4.6 hereof and 7.1 of the * License Agreement (and
the subsections thereunder), provided that such termination is
exercised with respect to United States; (iv) * 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 (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 * License
Agreement shall terminate with respect to the right to sell
the Product in such country(ies); (vi) all Registrations
pertaining to the Product shall be * as to the affected
country(ies) and the data generated under this 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) under
the * License
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* Confidential treatment requested. The redacted material has been separately
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Agreement 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 * equal the
aggregate amount that had been paid by * to GJT 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 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. For example, the termination remedy shall be
limited to the country or countries affected by (i) a breach by GJT or
its Affiliates of section 6.3, or (ii) APOTHECON's failure to pay
royalties in accordance with the * License Agreement for 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 entities * to terminate this Agreement pursuant to
this section 11.2.2, then, if * elects to terminate this
Agreement: (i) all rights granted to * under this Agreement *;
(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 hereof and section 7.1 of the * License Agreement
(and the subsections thereunder); (iii) the * License
Agreement shall terminate with respect to the right to sell
the Product in such country(ies); (iv) all Registrations
pertaining to the Product shall be * as to the affected
country(ies) and the * under this 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) under the *
License Agreement 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 * prior to such
termination under sections 4.6 and 7.1 hereof (and the
subsections thereunder), at which time * of the rate then
applicable 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 11.2.1, then, if APOTHECON
elects to terminate this
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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 shall * with respect to such
country(ies) so terminated; (iii) * will be relieved
of any * that are scheduled or may be made in the
future under section 4.6 hereof and section 7.1 of
the * License Agreement (and the subsections
thereunder); (iv) all Registrations pertaining to the
Product shall be * as to the affected country(ies)
and the * under this Agreement shall be provided to
and thereafter may be * to develop, manufacture and
market the Product; (v) the * License Agreement shall
terminate with respect to the right to sell the
Product in such country(ies); and (vi) * and its
Affiliates shall thereafter be entitled * 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 quantities 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 released 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 *; (iii) * shall be
relieved of any * that are scheduled or may be made
in the future under sections 4.6 hereof and 7.1 of
the * License Agreement (and the subsections
thereunder), provided that such termination is
exercised with respect to United States; (iv) * 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 (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 *
License Agreement shall terminate with respect to the
right to sell the Product in such country(ies); (vi)
all Registrations pertaining to the Product shall be
* as to the affected country(ies) and the * under
this Agreement shall be provided to and thereafter
may be * to develop, manufacture and market the
Product; and (vii) * shall pay to *
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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) under the *
License Agreement 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 royalty 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 * 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 royalty rate then
prevailing on * (or on the * of such *, as the case
may be) in the United States shall be *).
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 (biobatches) 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
irrespective of whether APOTHECON is 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 of the * License Agreement shall be * and all
royalty rates applicable to all * in the Territory at any time
thereafter under the * License Agreement shall be * provided,
* 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.
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* Confidential treatment requested. The redacted material has been separately
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If APOTHECON elects not to terminate this Agreement in
accordance with this section 11.2.3.2, then all payments due
after * under section 7.1 of the * License Agreement shall be
eliminated and waived, and all royalty rates applicable to all
* in the Territory under the * License Agreement at any time
thereafter shall be * provided, that such reductions 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.
11.2.4 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 any 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 hereof 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 hereof, any payments to be
made thereafter by APOTHECON under said article shall
thereafter be paid to Jagotec, and APOTHECON shall continue to
enjoy all rights and privileges granted under said article.
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 of the * License
Agreement or section 6.3 hereof, or
ii) APOTHECON or its Affiliates breach section 3.1 of the *
License Agreement,
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
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* Confidential treatment requested. The redacted material has been separately
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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 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.
11.3 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.
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 of the *
License Agreement, 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 2.3 shall survive any expiration of
this Agreement under section 1.1(iii), and
(ii) Articles 5.7, 6.4, 6.5, 8.3-8.5, 8.7, 10, 11.2.4.2,
11.2.5, 11.2.7, 11.4-11.6, 12, 14, 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.
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* Confidential treatment requested. The redacted material has been separately
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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.
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 this 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 any 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) enter
into an agreement with Jago Pharma under which 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 hereof, 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 (iv) enter into an agreement with Jagotec
under which Jagotec will assume all rights and obligations of GJT under
article 8 hereof, any payments to be made thereafter by APOTHECON under
said article shall thereafter be paid to Jagotec, and APOTHECON shall
continue to enjoy all rights and privileges
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* Confidential treatment requested. The redacted material has been separately
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granted under said article. Upon request, Jagotec and Jago Pharma AG
will deliver to APOTHECON satisfactory confirming written documentation
of same.
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 of the * License Agreement, 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
12.1 Indemnity.
12.1.1 Indemnity by APOTHECON. APOTHECON shall defend, indemnify and
hold Jagotec, GJT, their respective Affiliates and their respective
directors, officers, employees, consultants, contractors,
Subcontractees, and agents (each a "GJT Indemnitee") harmless from and
against * (including reasonable attorneys' fees and costs of
litigation, *) as a result of any claim, demand, action or other
proceeding by a Third Party based upon any death, bodily injury or
physical property damage arising from or relating to the manufacture
(including without limitation failure to manufacture Product in
accordance with the Specifications or adulteration of Product)
distribution, use, handling, packaging, labeling, promotion,
marketing, storage, or sale of Products by or on behalf of *, its
Affiliates and its and their, licensors, licensees, sublicensees,
contractors and subcontractors, except:
12.1.1.1 to the extent such damages or other amounts payable
arise from or are attributable to:
(i) the negligence, fault or willful misconduct
of any *, or
(ii) * of the terms of the * License Agreement and/or of
this Agreement (or adulteration of the Product while
under the control of * or any of its contractees), or
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* Confidential treatment requested. The redacted material has been separately
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(iii) reliance upon any written instructions or
written information pertaining to the
manufacture and storage conditions of the
Product and/or the use of the GEOMATRIX
technology in connection therewith provided by
*, any of its Affiliates, or its or their
licensors, contractors and Subcontractees.
12.1.2 Indemnity by GJT. GJT shall defend, indemnify and hold
APOTHECON, its respective Affiliates, and its and their respective
directors, officers, employees, consultants, contractors,
subcontractors and agents (each an "APOTHECON Indemnitee") harmless
from and against * (including reasonable attorneys' fees and costs of
litigation, *) as a result of any claim, demand, action or other
proceeding by a Third Party based upon death, bodily injury or
physical property damage arising from or relating to the development
of the Product, the Specifications provided, and/or any written
instructions or written information provided by GJT or its Affiliates
pertaining to the use of the GEOMATRIX technology in connection with
the manufacture or storage of the Product, except:
12.1.2.1 to the extent such damages or other amounts payable
arise from or are attributable to:
(i) *, or
(ii) *.
12.2 Procedure. It is a condition precedent to a party's obligations
under Section 12.1 above that:
12.2.1 A party (the "Indemnitee") that intends to claim indemnification
under this Article 12 promptly shall notify the other (the
"Indemnifying Party") of any claim, demand, action or other proceeding
with respect to which the Indemnitee intends to claim such
indemnification. The failure of an Indemnitee to deliver notice to the
Indemnifying Party within a reasonable time after the commencement of
any such action or other proceeding, if prejudicial to the Indemnifying
Party's ability to defend such action or other proceeding, shall
relieve the Indemnifying Party of any obligation or liability it may
have under Section 12.1, provided that the failure to deliver such
notice shall not relieve the Indemnifying Party of any liability it may
have otherwise than under Article 12.1; and
12.2.2 The Indemnifying Party shall have the right to participate in
and, to the extent it so desires, to assume sole control of the defense
thereof (including all decisions relative to settlement, litigation and
appeal) with counsel selected by the Indemnifying Party; provided,
however, that the Indemnitee shall have the right to retain its own
counsel with the fees and expenses to be paid by the Indemnitee if
representation of the Indemnitee by the counsel retained by
Indemnifying Party would be inappropriate due to actual or potential
conflicting interests between the Indemnitee and any other party
represented by such counsel in such proceedings. The indemnity
obligations under this Article 12 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such
settlement is effected without the prior written consent of the
Indemnifying Party; and
12.2.3 Each lndemnitee shall cooperate fully (to the extent such
cooperation would not be inappropriate due to actual or potential
conflicting interests) with the Indemnifying Party and its legal
representatives in the investigation and defense of any claim, demand,
action or other proceeding covered by this Article 12; provided, that
the failure of an Indemnitee to provide such cooperation shall not
affect the Indemnifying Party's obligations under Section 12.1 to any
other Indemnitee not capable of exercising control over such
noncooperative Indemnitee.
12.3 Insurance. Each Indemnifying Party shall *, with
respect to its indemnification obligations under this Agreement in such *
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* Confidential treatment requested. The redacted material has been separately
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* under-taking activities with products of a similar nature to the Products
being manufactured and sold hereunder. After the commencement of human clinical
trials or the commercial sale of the Product or other product, each party, as
applicable, .
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
APOTHECON understands that GJT intends to contract with one or more
Affiliates and other Persons ("Subcontractees") to perform certain of its duties
hereunder, including without limitation, subcontracting with one or more
contract research organizations to perform necessary clinical studies. All such
Subcontractees must be reasonably acceptable to APOTHECON. All such arrangements
shall be evidenced by written agreement(s) between GJT and such Subcontractee(s)
which are consistent with the terms of this Agreement and which accord APOTHECON
the same rights, benefits and options under such agreements as APOTHECON has
hereunder with GJT, including without limitation, the right of APOTHECON, upon
reasonable notice and at reasonable times, to examine a Subcontractee's
facilities, to make copies of relevant records and monitor the work performed
thereunder pertaining to the Product, and to determine the adequacy of the
facilities and whether the pertinent duties are being performed in compliance
with this Agreement and relevant governmental requirements. Any such subcontract
shall be subject to the terms and conditions of the Agreement, and any
Subcontractee shall be bound by all obligations and undertakings of GJT
hereunder (as they relate to the obligations and rights so assigned or
delegated). All such agreements shall be submitted by GJT to APOTHECON for
review, which GJT shall use commercially reasonable efforts to effect in advance
of execution to allow APOTHECON reasonable opportunity to comment thereon. A
copy of each such executed Subcontractee agreement, and any amendments or
supplements thereto, shall be promptly provided by GJT to APOTHECON following
execution of same.
All compensation, reimbursement of costs and other payments to be made
for any such Subcontractee's services is solely a matter between GJT and such
Subcontractee(s), and GJT shall indemnify and hold APOTHECON harmless from and
against any claims of compensation, cost reimbursement or other payments claimed
by any such Subcontractee(s) in connection with the performance of this
Agreement.
GJT will ensure (with respect to any Affiliate Subcontractee), and will
use commercially reasonable efforts to ensure (in the case of any other
Subcontractee), that APOTHECON is expressly designated as a third party
beneficiary of a Subcontractee's obligations to GJT pertaining to this Agreement
and of GJT's rights under such Subcontractee's written agreement with GJT. GJT
will be responsible and liable to APOTHECON for any breach by any such
Subcontractee of its obligations under such agreements and for the failure by
such Subcontractee to perform any duties hereunder assigned or delegated to such
Subcontractee.
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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.
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
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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.l(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. l(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.
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.
-33-
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
beethovenstrasse 7
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
with a copy to: Apothecon, Inc.
000 Xxxxxxxx Xxxx Xxxx
Xxxxxxxxxx, Xxx Xxxxxx 00000 XXX
Attention: Corporate Legal Counsel
-34-
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, turnover 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 a an Article (or
section) shall be deemed to include reference to all sections and subsections
thereunder.
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.
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 * License Agreement) to the extent herein referenced,
together with all of the documents referred to herein as having been provided by
one party to another and the letter agreement of even date herewith between
Jagotec, GJT and APOTHECON (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.
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
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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).
-36-
IN WITNESS WHEREOF, the parties hereto have duly executed the Agreement
as of the date first set forth above.
APOTHECON, INC.
By: /s/
-----------------------
Title: VP/XX
XXXXX 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 above
Agreement and sections 11.2.4.2 and 11.5 of the * License 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:
JAGOTEC AG
By: /s/ Xxxxxxx Xxxxxxx
-------------------
Xx. Xxxxxxx Xxxxxxx
President
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 above Agreement and
sections 11.2.4.2 and 11.5 of the * License 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
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
-37-
EXHIBITS
Exhibit 1.1(i) Initial Project Addendum for the Development Program
Exhibit 1.1(ii) List of Patent Rights
Exhibit 3.6(i)-(iv) Waiver and Consent Agreements
Exhibit 4.2 Initial Product Specifications
Exhibit 9.1 List of GEOMATRIX Trademarks
-38-
EXHIBIT 1.1(i)
INITIAL PROJECT ADDENDUM FOR THE
DEVELOPMENT PROGRAM
--------------------------------------------------------------------------------
*
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
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 4.2
INITIAL PRODUCT SPECIFICATIONS
--------------------------------------------------------------------------------
*
------------------
* Confidential treatment requested. The redacted material has been separately
filed with the Commission.
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
