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EXHIBIT 10.30
DELIVERY TECHNOLOGY LICENSE AGREEMENT
This Delivery Technology License Agreement ("Agreement") is made as of
January 1, 1999 (the "Effective Date") by and between Introgen Therapeutics,
Inc., a Delaware corporation ("Introgen"), and Gendux, Inc., a Delaware
corporation ("Gendux").
BACKGROUND
A. Introgen and Gendux are parties to that certain Administrative
Services and Management Agreement of even date herewith (the "Services
Agreement"), pursuant to which Introgen will provide certain administrative and
management services, all as set forth therein;
B. Introgen owns and/or controls rights to certain gene therapy
technologies;
C. Gendux desires to obtain from Introgen a license to such gene
therapy technologies, all on the terms and conditions set forth below; and
D. The parties desire that Gendux commercialize such gene therapy
technologies for applications within the Field (as defined below). In this
connection, Introgen and Gendux have entered into that certain Target Gene
License Agreement of even date herewith (the "TGLA Agreement"), pursuant to
which Introgen licensed certain genes and rights to Gendux, all on the terms and
conditions set forth therein, and that certain Research and Development
Agreement of even date herewith (the "Development Agreement"), pursuant to which
Introgen has agreed to assist Gendux in performing a certain developmental
research program within the Field, all as set forth therein.
NOW, THEREFORE, in consideration of the mutual covenants, conditions
and undertakings herein contained, the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms shall have the meanings
indicated:
1.1 "Affiliate" shall mean any entity which controls, is controlled by
or is under common control with Introgen or Gendux. For purposes of this
definition, "control" shall mean beneficial ownership (direct or indirect) of
more than fifty percent (50%) of the shares of the subject entity entitled to
vote in the election of directors (or, in the case of an entity that is not a
corporation, for the election of the corresponding managing authority).
Notwithstanding the foregoing, neither Introgen nor Gendux shall be deemed to be
an Affiliate of the other for purposes of this Agreement.
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1.2 "Control" shall mean, except only for the purposes of Section 1.1
above, possession of the ability to grant a license or sublicense under this
Agreement without violating the terms of any agreement or other arrangement with
a third party.
1.3 "Field" shall mean [*].
1.4 "First Financing" shall mean the closing of the sale and/or
issuance of equity and/or debt securities by Gendux, as a result of which the
cumulative total of cash proceeds from such financings received by Gendux
exceeds [*].
1.5 "Licensed Patents" shall mean any and all rights in:
(a) all worldwide patents and patent applications that are
Controlled by Introgen as of the Effective Date (collectively, the "Existing
Patents");
(b) all worldwide patents and patent applications that are
Controlled by Introgen during the term of this Agreement, to the extent the
same claim and disclose a Development Invention (as defined in the Development
Agreement) (collectively, the "Development Patents"); and
(c) all divisions, continuations, continuations-in-part, foreign
counterparts, patents of addition, and substitutions of, and all patents issuing
on, any of the foregoing, together with all registrations, reissues,
reexaminations or extensions of any kind with respect to any of such patents, in
each case that are Controlled by Introgen during the term of this Agreement and
to the extent the same claim and disclose a Development Invention or an
invention claimed and disclosed in an Existing Patent.
1.6 "Licensed Product" shall mean any product, composition or material
the development, manufacture, use or sale of which incorporates, utilizes, is
derived from, or is otherwise based upon the Licensed Technology.
1.7 "Licensed Technology" shall mean the Licensed Patents and the
Related Materials.
1.8 "Manufacturing Costs" shall mean, with respect to a Licensed
Product, the costs that are incurred by Introgen, or its respective Affiliate,
associated with the manufacture, filling, packaging, labeling and/or other
preparation of such Licensed Product, as determined in accordance with generally
accepted accounting principles in the United States.
1.9 "Net Sales" shall mean the total amount invoiced to non-Affiliate
third parties on sales of Licensed Products by Gendux, its Affiliates, or
Sublicensees, less the following reasonable
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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and customary deductions: (i) all trade, cash and quantity credits, discounts,
refunds or rebates actually allowed to the customer; (ii) amounts for claims,
allowances or credits for returns, and retroactive price reductions actually
allowed to the customer; (iii) handling fees and prepaid freight, sales taxes,
duties and other governmental charges (including value added tax), in each case
to the extent stated separately on the invoice and paid by the customer; and
(iv) provisions for uncollectable accounts determined in accordance with
reasonable accounting practices, consistently applied to all products of the
selling party. For the removal of doubt, Net Sales shall not include sales by
Gendux to its Affiliates for resale, provided that if Gendux sells a Licensed
Product to an Affiliate for resale, Net Sales shall include the amounts invoiced
by such Affiliate to third parties on the resale of such Licensed Product.
1.10 "Related Materials" shall mean such technical information,
processes, procedures, compositions, biological materials, data and know-how as
the parties mutually agree are reasonably necessary for the proper conduct of
the R&D Program (as defined in the Development Agreement), in each case to the
extent the same are Controlled by Introgen.
1.11 "Sublicensee" shall mean any non-Affiliate third party to whom
Gendux has granted, directly or indirectly, a right or license to market, sell
or distribute Licensed Products.
1.12 "Target Genes" shall have the meaning defined in the TGLA.
1.13 "Third Party Agreements" shall mean collectively those agreements
between Introgen and a third party existing as of the Effective Date, as listed
on Exhibit A hereto, pursuant to which Introgen obtained rights to Licensed
Technology applicable to the Field. If after the Effective Date either Introgen
and/or Gendux enter into an agreement to license or acquire rights from a third
party with respect to subject matter in accordance with Section 3.3.2 below,
such agreements shall also be deemed Third Party Agreements for purposes for
this Agreement.
ARTICLE 2
LICENSE
2.1 Grant. Introgen hereby grants to Gendux a worldwide, non-exclusive,
royalty-bearing license under the Licensed Technology to make, use, import and
sell Licensed Products, in each case for purposes solely within the Field.
2.2 Sublicenses. Gendux may grant sublicenses within the scope of the
license granted to Gendux under Section 2.1 above to the extent necessary or
useful for exercising such license. Gendux agrees to provide to Introgen a copy
of any agreement pursuant to which a sublicense is granted to the Licensed
Technology promptly after the signing of such agreement.
2.3 Restrictions. Notwithstanding Sections 2.1 and 2.2 above, Gendux
covenants not to manufacture or have manufactured Licensed Products (or to grant
any third party the right to manufacture or have manufactured Licensed Products)
except to the extent expressly permitted in
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Section 4.3 below. In such event, Introgen shall provide to Gendux copies of all
documentation within Introgen's Control that is reasonably necessary for Gendux
to manufacture or have manufactured Licensed Products in accordance with Section
4.3 below, and shall reasonably cooperate with Gendux to establish supply
thereof, including sources of materials. Without limiting the foregoing, in the
event that Gendux has any Licensed Product manufactured by a third party, such
third party shall enter into a confidentiality agreement with Introgen to
protect against the unauthorized use and disclosure of Introgen's Confidential
Information.
2.4 Improvements. Gendux hereby grants to Introgen a worldwide,
perpetual, non-exclusive, fully paid-up license for all purposes, with the right
to grant and authorize sublicenses, under any and all improvements to the
Licensed Technology, which improvements are made by Gendux or by third parties
on behalf or under the authority of Gendux. As used herein, "improvements" to
the Licensed Technology shall mean any invention, biological material or other
subject matter that is made using, or derived in whole or in part from, any
Licensed Technology, and shall in any event be deemed to include (without
limiting the foregoing) any invention, material and subject matter useful in
connection with the delivery of genetic constructs or gene therapy; it being
further understood that the license granted in this Section 2.4 shall extend to
all patent and other rights in such improvements. Gendux agrees to (i) promptly
notify Introgen of any such improvements, (ii) provide with such notice samples
in reasonable quantities of any tangible materials within such improvements, and
(iii) keep Introgen fully informed of the status of any patents and patent
applications with respect to such improvements.
2.5 No Implied Licenses. Nothing herein shall be construed as granting
to either party, by implication, estoppel or otherwise, any license or other
right to any intellectual property of the other party other than those rights
expressly granted herein. Without limiting the foregoing provision of this
Section 2.5, nothing herein shall be deemed to grant to Gendux rights with
respect to any gene other than a Target Gene, or for any product that includes
any subject matter not expressly included within the Field.
ARTICLE 3
PATENT EXPENSES, ROYALTY PAYMENTS AND REPORTS
3.1 Royalty. In consideration of the rights and licenses granted by
Introgen to Gendux under this Agreement, except as otherwise provided in this
Article 3, Gendux shall pay to Introgen running royalties equal to [*] of Net
Sales by Gendux, its Affiliates or Sublicensees of Licensed Products.
3.1.1 Royalty Term. The obligation of Gendux to pay royalties under
this Article 3 shall continue with respect to each Licensed Product, on a
country-by-country basis, until the later of (i) the expiration of the
last-to-expire patent within the Licensed Patents covering such Licensed Product
in such country; or (ii) the abandonment, cancellation or withdrawal of the last
pending application for a patent within the Licensed Patents covering such
Licensed Product in such country; or (iii) ten (10) years after the date of the
first full commercial sale of such Licensed Product in such country.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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3.1.2 TGLA Royalties. It is understood and agreed that Gendux's
total royalty obligation under this Agreement and the TGLA shall not exceed a
cumulative total of [*] of Net Sales [*].
3.1.3 Combination Products. In the event that a Licensed Product is
sold in combination with another product or pharmaceutically active ingredient
which is not a Licensed Product or an Agreement Product (as defined in the
TGLA), Net Sales for purposes of calculating the amounts due under Section 3.1
above shall be allocated between said Licensed Product and such other product or
pharmaceutically active ingredient, as mutually agreed by Introgen and Gendux.
3.2 Sublicense Revenues.
3.2.1 General. In addition to the amounts due under Section 3.1
above, Gendux shall pay to Introgen [*] of all fees or other consideration
(other than running royalties calculated on Net Sales of a Licensed Product)
received by Gendux from its Sublicensees (including, without limitation,
up-front fees and milestone payments), [*]. Without limiting the foregoing, in
the event that Introgen and Gendux enter into an agreement such that Introgen
licenses from Gendux delivery technology other than the Licensed Technology, the
parties will negotiate in good faith with respect to Sublicense revenues on
terms substantially similar to those set forth in this Section 3.2.
3.2.2 Coordination with TGLA. In the event that Gendux receives
sublicense fees as described in Section 3.2 of the TGLA in connection with a
Sublicense under this Agreement, Introgen shall not be entitled to receive more
than [*] of the total amounts received for such a combined Sublicense of the
rights under this Agreement and under the TGLA.
3.2.3 Cap. It is understood that such Development Costs will not
exceed [*], less any amounts paid to Introgen pursuant to Section 3.2 of the
TGLA.
3.3 Third Party Payments.
3.3.1 Generally. Gendux shall promptly reimburse Introgen for any
amounts paid or payable by Introgen to third parties pursuant to a Third Party
Agreement (including agreements entered into as set forth in 3.3.2 below),
including without limitation any royalties, patent expenses, license fees or
milestone payments due to such third parties, which in each case become due as a
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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result of the exercise by, on behalf of or under the authority of Gendux in
accordance with this Agreement of the licenses granted to Gendux under Section
2.1. Without limiting the foregoing, it is understood that all [*]. In the event
that amounts are due under a Third Party Agreement that are not directly
attributable to activities of Gendux (such as annual license fee payments,
patent expenses, milestone payments that are triggered by achievements of
Introgen or third parties but that reduce or eliminate corresponding payments by
Gendux for the achievement of such milestones), Gendux shall reimburse Introgen
for a reasonable portion of such payments, based on the relative benefit to
Gendux of such payments.
3.3.2 Future Agreements. It is understood and agreed Introgen may
choose to license or otherwise acquire technology from third parties which would
be subject to the licenses granted hereunder, but Introgen has no obligation to
do so. In the event that Introgen proposes to acquire such technology and offer
to Gendux to include the same within the Licensed Technology hereunder
("Acquired Technology"), Introgen shall disclose the same to Gendux, including
any royalty or other payment obligations that would apply to the exercise of
Gendux's license hereunder. Gendux shall notify Introgen in writing within
fifteen (15) days whether it desires such Acquired Technology to be included in
licenses granted hereunder. If Gendux so notifies and so desires, the Acquired
Technology shall be included in the Licensed Technology and if Gendux fails to
notify Introgen or notifies that it does not desire a license to such Acquired
Technology, then the Acquired Technology shall be excluded from the Licensed
Technology and Gendux shall not have a license thereto. The agreement under
which Introgen acquires Acquired Technology included within the Licensed
Technology as set forth above shall be a "Third Party Agreement" for purposes of
this Agreement.
3.3.3 Payment; Reports. If Introgen is obligated to pay amounts to
a third party pursuant to a Third Party Agreement subject to reimbursement
pursuant to Section 3.3.1 above, Introgen shall notify Gendux reasonably in
advance, and Gendux shall reimburse its share of such payments by the earlier of
(i) ten (10) days before such amounts are payable to such third party or (ii)
thirty (30) days after receipt of notice therefor. In addition, to the extent
that Introgen is obligated to provide reports to a third party pursuant to a
Third Party Agreement as a result of or reporting on the status of activities of
Gendux, Gendux shall reasonably assist Introgen by providing information in its
possession or control and in sufficient detail to complete and submit such
reports as required.
3.4 Royalty Reports and Payments. After the first sale of a Licensed
Product by Gendux, its Affiliates or Sublicensees, Gendux shall deliver to
Introgen within forty-five (45) days after the end of each calendar quarter, a
written report, certified by an officer of Gendux, setting forth in reasonable
detail the calculation of the royalties due to Introgen for such calendar
quarter, which calculation shall include, without limitation, the number,
description, and aggregate Net Sales of Licensed Products sold during such
calendar quarter. Simultaneously with the delivery of each such report, Gendux
shall pay to Introgen the total royalties, if any, due to Introgen for the
period of such report. If no royalties are due, Gendux shall so report. All
financial information contained in reports
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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provided to Introgen pursuant to this Section 3.4 shall be treated as
Confidential Information of Gendux pursuant to Article 11.
3.5 Payment Method. All amounts payable under this Agreement shall be
made by bank wire transfer in immediately available funds to an account
designated by Introgen. All dollar amounts specified in this Agreement are
expressed, and all payments hereunder shall be made, in U.S. dollars. Any
payments or portions thereof due under this Agreement which are not paid on the
date such payments are due under this Agreement shall, to the extent permitted
by applicable law, bear interest at [*], on the first business day after such
payment is due, calculated on the number of days such payment is delinquent.
3.6 Currency Conversion. If Gendux receives revenues from Net Sales of
Licensed Products in currency other than U.S. dollars, for purposes of
calculating royalties hereunder, such revenues shall be converted using the
selling exchange rate for conversion of the foreign currency into U.S. dollars,
quoted for current transactions reported in The Wall Street Journal (U.S.) for
the last business day of the applicable calendar quarter.
3.7 Records; Inspection. Gendux shall keep, and require its Affiliates
and Sublicensees to keep, complete, true and accurate books of account and
records for the purpose of determining the amounts payable pursuant to this
Agreement. Such books and records shall be kept for at least three (3) years
following the end of the calendar quarter to which they pertain. Such records
will be open for inspection during such three (3) year period by a
representative or agent of Introgen for the purpose of verifying the amounts
payable by Gendux hereunder. Such inspections may be made no more than once each
calendar year, at reasonable times and on reasonable notice. Introgen's
representative or agent will be obliged to execute a reasonable confidentiality
agreement prior to commencing any such inspection. Introgen shall bear the costs
and expenses of inspections conducted under this Section 3.7, unless a variation
or error producing an underpayment in amounts payable exceeding ten percent
(10%) of the amount paid for the period covered by the inspection is established
in the course of any such inspection, whereupon all costs relating to the
inspection and any unpaid amounts that are discovered shall be paid by Gendux,
together with interest on such unpaid amounts at the rate specified in Section
3.5 above.
3.8 Taxes. All payments by Gendux specified hereunder are expressed as
net amounts and shall be made free and clear of, and without reduction for, any
taxes. Any such taxes (including, without limitation, foreign withholding taxes)
which are otherwise imposed on payments to Introgen shall be the sole
responsibility of Gendux. Gendux shall provide Introgen with official receipts
issued by the appropriate taxing authority or such other evidence as is
reasonably requested by Introgen to establish that such taxes have been paid. If
Introgen has the legal obligation to collect and/or pay any sales, use, excise
or value added taxes, the appropriate amount shall be added to Gendux's invoice
and paid by Gendux, unless Gendux provides Introgen with a valid tax exemption
certificate authorized by the appropriate taxing authority.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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ARTICLE 4
MANUFACTURING RIGHTS
4.1 Manufacture and Supply. Subject to Section 4.3 below, Introgen
shall have the worldwide, exclusive right to manufacture, or have manufactured,
and supply to Gendux Licensed Products for use or sale in the Field, and except
as set forth below, Gendux shall purchase exclusively from Introgen all of
Gendux', its Affiliates' and Sublicensees' Requirements of Licensed Products. It
is understood that Introgen may, at its election, engage subcontractors with
respect to the manufacture of Licensed Products for supply to Gendux.
4.2 Transfer Price. Licensed Products to be supplied by Introgen to
Gendux for use or sale within the Field shall be supplied at a price equal to
Introgen's Manufacturing Costs therefor [*]; provided, however, that with
respect to Licensed Products used for clinical research and regulatory affairs
necessary to obtain the government approvals required to market such Licensed
Products, the price will be equal to Introgen's Manufacturing Costs therefor
[*]. Notwithstanding the foregoing, as long as Introgen owns forty percent (40%)
or more of the fully diluted capitalization of Gendux, the price will be equal
to Introgen's Manufacturing Costs therefor [*].
4.3 Gendux Right to Supply. In the event that Introgen elects not to
supply quantities of Licensed Products within the Field, or fails to supply such
quantities under the terms and conditions established under Section 4.4 below,
Gendux shall have the right to manufacture, or have manufactured, and supply
(and/or authorize its Sublicensees to do so, subject to Section 2.3 above) the
quantities that Introgen so elects not to or fails to supply, for use or sale
(as the case may be) within the Field.
4.4 Supply Agreement. Upon request by Introgen or Gendux, the parties
shall enter into a supply agreement on reasonable and customary terms with
respect to the supply arrangements contemplated in this Article 4.
ARTICLE 5
DUE DILIGENCE
5.1 Gendux shall use its best efforts, itself or though a Sublicensee
on a worldwide basis, to develop for commercial sale, obtain regulatory approval
to market, and to market, promote and distribute Licensed Products for each of
the Target Genes, in each case as soon as practicable. Any efforts of Gendux's
Sublicensees shall be considered efforts of Gendux for the sole purpose of
determining Gendux's compliance with its obligation under this Section 5.1.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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5.2 Upon request by Introgen, Gendux shall provide Introgen on each
December 1 with written progress reports, summarizing in reasonable detail the
progress of the development, evaluation, testing and commercialization of each
Licensed Product.
ARTICLE 6
TERM AND TERMINATION
6.1 Term. Unless terminated earlier pursuant to this Article 6, the
term of this Agreement shall commence on the Effective Date and continue in full
force and effect until expiration, revocation or invalidation of the last patent
or the abandonment of the last patent application within the Licensed Patents,
whichever is later.
6.2 Termination by Introgen. In the event the First Financing does not
occur on or before [*], Introgen may terminate this Agreement upon
written notice.
6.3 Termination for Breach. Either Gendux or Introgen may terminate
this Agreement, in the event the other shall have materially breached or
defaulted in the performance of any of its obligations hereunder and such breach
shall have continued for thirty (30) days after written notice is given by the
nonbreaching party to the breaching party specifying the breach. For such
purposes, a breach of the TGLA, the Development Agreement or the Services
Agreement shall be deemed a breach of this Agreement.
6.4 Termination of TGLA. Without limiting the foregoing, this Agreement
shall terminate automatically upon termination of the TGLA.
6.5 Survival.
6.5.1 Termination of this Agreement for any reason shall not
release either party hereto from any liability which, at the time of such
termination, has already accrued to the other party or which is attributable to
a period prior to such termination, nor preclude either party from pursuing any
rights or remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement.
6.5.2 In the event this Agreement is terminated for any reason,
Gendux and its Affiliates shall have the right to sell or otherwise dispose of
the stock of any Licensed Products then on hand within one hundred twenty (120)
days of such termination, all subject to the payment to Introgen of fees and
royalties pursuant to Article 3 hereof.
6.5.3 Articles 1, 8, 9, 10, 11, and 12 and Sections 2.4, 3.7 and
6.5 shall survive the expiration and any termination of this Agreement. Except
as otherwise provided in this Article 6, all rights and obligations of the
parties under this Agreement shall terminate upon the expiration or termination
of this Agreement.
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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ARTICLE 7
INFRINGEMENT BY THIRD PARTY
7.1 Enforcement. During the term of this Agreement, in the event that
Gendux reasonably believes that any Licensed Technology is being infringed or
otherwise misappropriated by a third party by reason of the manufacture or sale
of a product within the Field, Gendux shall promptly notify Introgen in writing.
In the event Introgen does not initiate an action to enforce such Licensed
Technology against a commercially significant infringement in the Field by a
third party within one hundred eighty (180) days of a written request by Gendux
to do so, Gendux may initiate such action with Introgen's prior written consent.
Any amount recovered in such action shall first be applied to reimburse the
out-of-pocket costs of such action, and the remainder shall be [*].
7.2 Defense. If Gendux, its Affiliate, Sublicensee, distributor or
other customer is sued by a third party charging infringement of patent rights
that dominate a claim of the Licensed Patents or that otherwise cover the
manufacture, use, distribution or sale of a Licensed Product, Gendux will
promptly notify Introgen in writing. As between the parties to this Agreement,
Gendux will be entitled to control the defense in any such action, provided that
Introgen shall have the right to participate in the defense or settlement
thereof at its own expense with counsel of its own choosing. Except as agreed in
writing by Introgen, Gendux shall not enter into any settlement of any such
action if such settlement admits the unpatentability, invalidity or
unenforceability of any Licensed Technology. Gendux agrees to keep Introgen
reasonably informed of all developments in connection with any such action.
7.3 Cooperation. In any suit, action or other proceeding in connection
with defense of the Licensed Technology , Introgen shall reasonably cooperate
with Gendux with respect to such proceeding, at Gendux's expense. In any suit,
action or other proceeding in connection with enforcement of the Licensed
Technology, Gendux shall reasonably cooperate with Introgen with respect to such
proceeding, at Introgen's expense.
7.4 Patent Prosecution.
7.4.1 Prosecution by Introgen. Introgen shall have the right, at
its option, to control the filing for, prosecution and maintenance of the
Licensed Patents. Upon request by Gendux from time to time, Introgen shall
advise Gendux as to the status of any particular patent or patent application
within the Licensed Patents within the Field.
7.4.2 Prosecution by Gendux. If Introgen elects not to file,
prosecute or maintain any patent application or issued patent within the
Licensed Patents or pay any fee related thereto, in any country, Introgen shall
promptly notify Gendux of such election, but in no case later than sixty (60)
days prior to any required action relating to the filing, prosecution or
maintenance of such patent application or patent. In such event, upon notice to
Introgen, Gendux shall have the right, at its option, to control the filing,
prosecution and/or maintenance of any such patent applications or
[*] Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions.
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patents within the Licensed Patents at its own expense. In the event that Gendux
takes over the filing, prosecution and/or maintenance of any such patent
application or patent within the Licensed Patents, Gendux shall keep Introgen
reasonably informed on matters regarding such filing, prosecution and
maintenance. Without limiting the foregoing, Gendux shall consult with Introgen
in a timely manner concerning (i) the scope and content of patent applications
within the Licensed Patents prior to filing such applications, and (ii) the
content of and proposed responses to official actions of the U.S. Patent and
Trademark Offices and foreign patent offices during the prosecution of such
patent applications. For purposes of this Section 7.4.2, "timely" shall mean
sufficiently in advance of any decisions by Gendux or any deadline imposed upon
written response by Gendux so as to allow Introgen to review such decision
and/or written response and also provide comments to Gendux in advance of such
decision or deadline.
7.4.3 Other. If Gendux elects not to file, prosecute or maintain
any patent application or issued patent within the Licensed Patents or pay any
fee related thereto, in any country, Gendux shall promptly notify Introgen of
such election, but in no case later than sixty (60) days prior to any required
action relating to the filing, prosecuting or maintenance of such patent
application or patent. In such event, upon notice to Gendux, Introgen shall have
the right, at its option, to take over the filing, prosecution and/or
maintenance of any such patent application or patent within the Licensed Patents
at its own expense.
In addition if during the exercise of its rights under Section 7.4.2
above, Gendux fails, in Introgen's judgment, to appropriately file, prosecute
or maintain any particular patent or patent application within the Licensed
Patents, then upon notice from Introgen, Gendux's right to file, prosecute
and/or maintain such patent or patent application shall terminate and Introgen
shall have the right, at its option, to control the filing, prosecution and/or
maintenance of such patent or patent application within the Licensed Patents at
its own expense. In such event, Gendux shall cooperate and take all steps
necessary to transfer to Introgen the filing, prosecution and/or maintenance of
such patent or patent application within the Licensed Patents.
7.5 No Implied Obligations. Neither party has any obligation to bring
or prosecute actions or suits against any third party for patent infringement.
Notwithstanding the foregoing, it is understood that the parties' rights and
obligations hereunder are subject to the Third Party Agreements.
ARTICLE 8
INSURANCE; INDEMNIFICATION
8.1 Insurance. Gendux shall secure and maintain in effect during the
term of this Agreement and for a period of three (3) years thereafter insurance
policy(ies) underwritten by a reputable insurance company and in a form and
having limits standard and customary for entities in the biotechnology industry
for exposures related to Gendux's indemnification obligations pursuant to this
Article 8 below. Such insurance shall include general liability, clinical trial
liability and
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product liability coverage with respect to the development and commercialization
of Licensed Products and shall name the Indemnitees (as defined below) as
additional insureds thereunder. Upon request by Introgen, Gendux shall provide
to Introgen certificates of insurance evidencing the coverage required above.
8.2 Indemnification. Gendux shall indemnify each of Introgen and its
directors, officers and employees and the successors and assigns of the
foregoing (collectively, the "Indemnitees"), and hold each Indemnitee harmless
from and against any and all liabilities, damages, settlements, claims, actions,
suits, penalties, fines, costs or expenses (including, without limitation,
reasonable attorneys' fees and other expenses of litigation) incurred by any
Indemnitee arising from or occurring as a result any claim, action, suit, or
other proceeding brought by third parties against an Indemnitee arising from or
occurring as a result of (i) the exercise of the rights granted to Gendux under
Section 2.1, including without limitation product liability claims relating to
any Licensed Product used, sold or otherwise distributed by or on behalf of
Gendux or its Affiliates or (ii) Introgen's performance of its responsibilities
with respect to the R&D Program or the manufacture and supply of Licensed
Products hereunder or (iii) the gross negligence or willful tortious misconduct
of Gendux or any of its directors, officers or employees or the successors or
assigns of any of the foregoing. Notwithstanding the foregoing, Gendux shall
have no obligation under this Section 8.2 with respect to liabilities, damages,
settlements, claims, actions, suits, penalties, fines, costs or expenses to the
extent the same is caused by the gross negligence or willful tortious misconduct
of an Indemnitee.
8.3 Procedure. An Indemnitee that intends to claim indemnification
under this Article 8 shall: (i) promptly notify Gendux in writing of any claim,
action, suit, or other proceeding brought by third parties in respect of which
the Indemnitee intends to claim such indemnification; (ii) provide Gendux sole
control of the defense and/or settlement thereof, and (iii) provide Gendux, at
Gendux's request and expense, with reasonable assistance and full information
with respect thereto. Notwithstanding the foregoing, the indemnity obligation in
this Article 8 shall not apply to amounts paid in settlement of any loss, claim,
damage, liability or action if such settlement is effected without the consent
of Gendux, to the extent such consent is not withheld unreasonably or delayed.
Without limiting the foregoing provisions of this Section 8.3, Gendux shall keep
Introgen reasonably informed of the progress of any claim, suit or proceeding
under this Section 8.3 and Introgen shall have the right to participate in any
such claim, suit or proceeding with counsel of its choosing at its own expense.
ARTICLE 9
USE OF NAMES
Except as required by law or in the normal course of business
identification and description, neither party shall issue any press release or
other public statements in connection with this Agreement intended for use in
the public media in a manner suggesting any endorsement by the other party,
without the prior written approval of such other party, which approval shall
not be unreasonably withheld.
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ARTICLE 10
REPRESENTATIONS AND WARRANTIES
10.1 Introgen. Introgen hereby represents and warrants to Gendux that
(i) it has the full right and authority to enter into this Agreement and grant
the rights and licenses granted herein; (ii) it has not previously granted and
will not grant during the term of this Agreement any rights in the Licensed
Technology in the Field that are inconsistent with the rights and licenses
granted to Gendux herein; and (iii) to its knowledge, there are no claims of any
third parties pending against it that would call into question its right to
grant to Gendux the rights and licenses contemplated hereunder.
10.2 Gendux. Gendux hereby represents and warrants to Introgen that (i)
it has the full right and authority to enter into this Agreement and grant the
rights and licenses granted herein; (ii) it has not previously granted and will
not grant during the term of this Agreement any rights in conflict with the
rights and licenses granted herein; and (iii) to its knowledge, there are no
claims of any third parties pending against it that would call into question its
right to enter into and perform its obligations under this Agreement.
10.3 Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 10,
NEITHER PARTY MAKES ANY WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED, STATUTORY,
OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF, INCLUDING WITHOUT
LIMITATION, THE SUPPLY AND DEVELOPMENT OF LICENSED PRODUCTS, THE LICENSED
PRODUCTS THEMSELVES AND THE LICENSED TECHNOLOGY, AND INTROGEN SPECIFICALLY
DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, AND ALL WARRANTIES AND CONDITIONS OF THE
VALIDITY OF THE PATENT RIGHTS OR NONINFRINGEMENT OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS.
ARTICLE 11
CONFIDENTIALITY
11.1 Confidential Information. Except as expressly provided herein,
each party shall maintain in confidence, and shall not use for any purpose or
disclose to any third party, information disclosed by the other party in writing
and marked "confidential" or that is disclosed orally and confirmed in writing
as confidential within a reasonable time following such disclosure
(collectively, "Confidential Information"). Notwithstanding the foregoing,
Confidential Information shall not include any information that, in each case as
demonstrated by contemporaneous written documentation: (i) was already known to
the receiving party, other than under an obligation of confidentiality, at the
time of disclosure hereunder, or (ii) was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
receiving party, or (iii) became generally available to the public or otherwise
part of the public domain after its disclosure, other than
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through any act or omission of the receiving party, or (iv) was subsequently
lawfully disclosed to the receiving party by a person other than a party hereto
or (v) was independently developed by the receiving party without reference to
any information or materials disclosed by the disclosing party. For purposes of
this Article 11, the Licensed Technology shall be deemed Confidential
Information of Introgen.
11.2 Permitted Usage. Notwithstanding the provisions of Section 11.1
above, each party may use or disclose the other party's Confidential Information
to the extent such use and disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation, complying
with applicable governmental regulations, submitting information to tax or other
governmental authorities conducting clinical trials or exercising its rights
hereunder (including granting any permitted sublicenses); provided that if a
party is legally required to make any public disclosures of the other party's
Confidential Information, to the extent it may legally do so, it will give
reasonable advance notice to the other party of such disclosure and will use its
reasonable efforts to secure confidential treatment of such Confidential
Information prior to its disclosure (whether through protective orders or
otherwise).
ARTICLE 12
GENERAL
12.1 Independent Contractors. The relationship of Gendux and Introgen
established by this Agreement is that of independent contractors. Nothing in
this Agreement shall be construed to create any other relationship between the
parties. Neither party shall have any express or implied right, power or
authority to assume, create or incur any expense, liability or obligation on
behalf of or in the name of the other party.
12.2 Confidential Terms. Except as expressly provided herein, each
party agrees not to disclose any terms of this Agreement to any third party
without the prior written consent of the other party, except as required by
securities or other applicable laws and (subject to reasonable conditions of
confidentiality) to prospective and other investors and such party's
accountants, attorneys and other professional advisors.
12.3 Assignment. This Agreement shall not be assignable by either party
to any third party without the prior written consent of the other party hereto,
except that either party may assign this Agreement without the other party's
consent to an entity that acquires all or substantially all of the business or
assets of the assigning party, in each case whether by sale, merger, transfer of
assets, operation of law or otherwise; provided that in either case, such
assignee or transferee promptly agrees in writing to be bound by the terms and
conditions of this Agreement. Without limiting the foregoing, in the event of
such merger or transfer or acquisition of assets, no intellectual property
rights of the assignee or its affiliate shall be included in the Licensed
Technology, to the extent that such intellectual property rights were owned or
Controlled by the assignee or its affiliate prior to such merger or transfer or
acquisition of assets, or are created outside the Development Agreement
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or by personnel who were not employees of the assigning party prior to the
merger or transfer or acquisition of assets. Upon a permitted assignment of this
Agreement, all references herein to the assigning party shall be deemed
references to the assignee. Any assignment not permitted under this Section 12.3
shall be null and void.
12.4 Force Majeure. Nonperformance of either party (except for payment
of amounts due hereunder) shall be excused to the extent that performance is
rendered impossible by strike, fire, earthquake, flood, governmental acts or
orders or restrictions, or any other reason, including failure of suppliers,
where failure to perform is beyond the reasonable control of the nonperforming
party. Without limiting the foregoing, the party subject to such inability shall
use reasonable efforts to minimize the duration of any force majeure event.
12.5 Patent Marking. Gendux agrees to xxxx, and have its Affiliates and
Sublicensees xxxx, all Licensed Products sold or otherwise distributed pursuant
to this Agreement in accordance with the applicable patent statutes or
regulations in the country or countries of manufacture and sale thereof.
12.6 Notices. All notices, requests and other communications hereunder
shall be made in writing and shall be sent by registered or certified mail,
return receipt requested, postage prepaid; facsimile transmission (receipt
verified); or express courier service (signature required), in each case to the
respective address or fax number specified below, or such other address or fax
number as may be specified in writing to the other party:
Gendux: Gendux, Inc.
000 Xxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, Xxxxx 00000
Attn: President
Fax: (000) 000-0000
with a copy to: Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxx, Esq.
Fax: (000) 000-0000
Introgen: Introgen Therapeutics, Inc.
000 Xxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, Xxxxx 00000
Attn: President
Fax: (000) 000-0000
with a copy to: Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxx, Esq.
Fax: (000) 000-0000
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12.7 Governing Law. This Agreement shall be governed by, and construed
and interpreted in accordance with, the laws of the State of Texas, without
regard to conflicts of laws principles. Exclusive venue and jurisdiction of any
disputes governed by this Agreement shall be in the federal courts for the State
of Texas. The parties hereby consent to the jurisdiction of such courts.
12.8 Compliance with Law. Gendux shall comply with all applicable laws
and regulations in connection with its activities pursuant to this Agreement.
12.9 Modification; Waiver. No amendment or modification of any
provision of this Agreement shall be effective unless in writing signed by the
party to be charged. No provision of this Agreement shall be varied,
contradicted or explained by any oral agreement, course of dealing or
performance, or any other matter not set forth in an agreement in writing and
signed by both parties hereto. No failure on the part of either party to
exercise, and no delay in exercising any right under this Agreement or provided
by statute or at law or in equity or otherwise, shall impair, prejudice or
constitute a waiver of any such right, nor shall any partial exercise of any
such right preclude any other or further exercise thereof or the exercise of any
other right.
12.10 Headings. Headings included herein are for convenience only, do
not form a part of this Agreement and shall not be used in any way to construe
or interpret this Agreement.
12.11 Severability. If any provision hereof should be held invalid,
illegal or unenforceable in any jurisdiction, the parties shall negotiate in
good faith a valid, legal and enforceable substitute provision that most nearly
reflects the original intent of the parties (or shall strike such provision in
the absence of such substitute provision) and all other provisions hereof shall
remain in full force and effect in such jurisdiction and shall be liberally
construed in order to carry out the intentions of the parties hereto as nearly
as may be possible. Such invalidity, illegality or unenforceability shall not
affect the validity, legality or enforceability of such provision in any other
jurisdiction.
12.12 Entire Agreement. This Agreement (including the Exhibit hereto)
together with the TGLA, the Development Agreement and the Services Agreement
(including the respective Exhibits thereto), each entered into by the parties of
even date, constitute the entire understanding and agreement between the parties
with respect to the subject matter hereof and supersede any and all prior
negotiations, representations, agreements, and understandings, whether written
or oral, between the parties with respect to such subject matter.
12.13 Counterparts. This Agreement may be executed in two counterparts,
each of which shall be deemed an original, but both of which together shall
constitute one and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed and delivered in duplicate originals.
INTROGEN THERAPEUTICS, INC.
By: /s/ XXXXX X. XXXXXXXX, XX.
---------------------------------------------------
Name: Xxxxx X. Xxxxxxxx, Xx.
-------------------------------------------------
Title: Chief Financial Officer
------------------------------------------------
GENDUX, INC.
By: /s/ XXXXX X. XXXXX
---------------------------------------------------
Name: Xxxxx X. Xxxxx
-------------------------------------------------
Title: President & CEO
------------------------------------------------
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EXHIBIT A
THIRD PARTY AGREEMENTS
[To be completed]
