EXHIBIT 10.1
SECOND AMENDED AND RESTATED LICENSE AGREEMENT
This Second Amended and Restated License Agreement ("Agreement"), effective this
31st day of July, 2007 is between the University of Chicago, an Illinois
not-for-profit corporation ("UNIVERSITY"), having its principal office at 5555
S. Woodlawn Avenue, Chicago, IL 60637 and Opexa Therapeutics, a Texas
Corporation ("LICENSEE") having its principal office at 2635 N. Crescent Ridge
Drive, The Woodlands, Texas 77381. Each hereunder may be referred to separately
as the ("Party"), or together as the ("Parties"). The Parties agree:
1. RECITALS.
A. To the best of the UNIVERSITY's knowledge at the date of execution of
this Agreement, the inventions identified in Schedule A were conceived
or first reduced to practice by the UNIVERSITY as Operator of Argonne
National Laboratory (ANL) in the performance of work under its U.S.
Department of Energy (DOE) Prime Contract No. W-31-109-ENG-38.
Pursuant to terms of the DOE Contract and 35 USC 200 et seq.,
UNIVERSITY has acquired certain rights in and to said inventions.
B. LICENSEE, a business entity specializing in the development of
therapeutic products, is interested in acquiring certain rights to
said inventions.
C. UNIVERSITY is willing to grant such rights so that said inventions may
be developed and used to the fullest extent for the benefit of the
U.S. economy and the general public.
D. The Parties agree that this Agreement is the entire understanding
between the Parties and supersedes all previous understandings and
agreements, including the license agreement executed on December 30,
2004 (the "First Amended and Restated License Agreement") between the
Parties. The First Amended and Restated License Agreement is hereby
terminated upon the date of execution of this Agreement.
2. DEFINITIONS. The following capitalized terms used in this Agreement shall
mean:
A. "Affiliate" means, as to any person or entity, any other person or
entity, which directly or indirectly controls, is controlled by or is
under common control with the Party. Control shall mean the right to
control, or actual control of, management of such other entity,
whether by ownership of voting securities, by agreement, or otherwise,
or the direct or indirect ownership of the maximum percentage of such
stock permitted under local laws or regulations in those countries
where fifty percent (50%) ownership by a foreign entity is not
permitted.
B. "Calendar Quarter" means each of the four, three-month periods ending
on March 31st, June 30th, September 30th, and December 31st.
C. "Calendar Year" means the twelve-month period ending on December 31st.
D. "Effective Date" means the date appearing in line 1 of this Agreement.
E. "Field" means all fields of use within the diagnosis of, production of
therapeutics for, or treatment of diseases and/or disorders in humans
and the use in animals only for the development of such products or
applications in humans. The Field includes making stem cells and
banking of stem cells for such purpose and diagnostics, drug testing,
therapeutics and screening of small molecules, proteins, and/or
peptides that may cause differentiation of stem cells in vitro and/or
in vivo and the stem cells themselves.
F. "Licensed Patents" means the patents and patent applications listed on
Schedule A and attached hereto, including all continuations,
divisionals, and corresponding foreign patent applications and any
patents that may issue therefrom and any reissues, renewals,
reexaminations, substitutions, or extensions of or to any such patents
or patent applications.
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G. "Licensed Product(s)" means any product covered by the scope of any
Valid Claim contained in any Licensed Patent or a product made by a
process, method or technique covered by the scope of any Valid Claim
in any Licensed Patent or methods of using any product covered by the
scope of any Valid Claim contained in any Licensed Patent.
H. "Licensed Method(s)" means any method, procedure or process whose use
or practice is within the scope of any Valid Claim of any Licensed
Patents including but not limited to any service or part of selling a
service, licensing a method of use or other means of deriving
commercial benefit from Licensed Products.
I. "Net Sales" means the gross sales of Licensed Product(s) and Licensed
Method(s) sold or otherwise distributed in the Territory, less the
following amounts directly chargeable to such sales as indicated on
individual invoices:
i. Customary trade, quantity or cash discounts and rebates actually
allowed and taken;
ii. Amounts repaid or credited to customers on account of rejections
or returns; and
iii. Freight and other transportation costs, including insurance
charges, and duties, tariffs, sales and excise taxes and other
governmental charges based directly on Sales, turnover or
delivery of such Licensed Products and actually paid of allowed
by LICENSEE and its Affiliates.
Net Sales shall be determined in accordance with generally accepted
accounting principles consistently applied.
J. "Research Compositions" means stem cells created under the Licensed
Patents and differentiated cells prepared from such stem cells.
K. "Royalties" means all amounts payable under Section 4.D and 4.E of
this Agreement.
L. "Sale" means any transaction in which a Licensed Product(s) and/or
Licensed Method(s) is placed with a third party for the benefit of
LICENSEE or a third party; provided "Sale" shall not include placement
or use of a Licensed Product(s) and/or Licensed Method(s) with or by a
third party which is for testing or experimental purposes, including
any animal or clinical trials so long as such placements are reported
to the UNIVERSITY and for which no Compensation is received.
M. "Sublicensee" shall mean any person, company or other entity granted a
Sublicense by LICENSEE, including Affiliates of the Sublicensee.
N. "Sublicense" shall mean any agreement entered into by LICENSEE with
any person, company or other entity pursuant to which any of the
rights granted to LICENSEE to the Licensed Patents are exercised.
O. "Tangible Materials" shall mean Research Compositions, Licensed
Product(s) remaining in inventory six (6) months after termination of
this Agreement, all materials created in support of the marketing and
sale of Licensed Product(s) and/or Licensed Method(s), and
confidential documents related to the Licensed Patents.
P. "Territory" means worldwide.
Q. "Valid Claim" means an issued claim of any unexpired Licensed Patent
or a claim of any pending patent application which has not been held
unenforceable, unpatentable or invalid by a decision of a court or
governmental body of competent jurisdiction, in a ruling that is
unappealable or unappealed within the time allowed for appeal; which
has not been rendered unenforceable through disclaimer or otherwise;
and which has not been lost through an interference proceeding or
irrecoverable failure to pay a maintenance fee.
3. GRANT OF RIGHTS.
A. Grant of Rights. Subject to the reservation described in Section 3.D
below, UNIVERSITY hereby grants to LICENSEE and its Affiliates, an
exclusive, non-transferable license, to make, have made, use, have
used, import, offer to sell, sell and/or have sold Licensed Products
and/or Licensed Method(s) within the Field and within the Territory
during the term of this Agreement.
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B. Sublicense. LICENSEE shall have the exclusive right to grant
Sublicenses to and under the Licensed Patents to third parties limited
to and consistent with the rights granted LICENSEE under Section 3.A
within the Field and within the Territory. LICENSEE shall provide
UNIVERSIY with a copy of each Sublicense within sixty (60) days of the
execution of the Sublicense. UNIVERSITY shall treat all such
Sublicenses as confidential pursuant to Section 8.B.
C. No Other Rights. No rights in and to the Licensed Patents other than
those provided in Sections 3.A. and 3.B., above, express or implied,
are conveyed by UNIVERSITY.
D. Reservation of Non-Commercial Rights. UNIVERSITY reserves for itself,
the worldwide right to use the Licensed Patents and to practice the
inventions claimed in the Licensed Patents for any educational and/or
non-commercial research purpose it may choose at its own discretion
and without any payment therefore. UNIVERSITY shall have the right to
grant non-exclusive Licenses to third parties to practice the
inventions claimed in the Licensed Patents for non-commercial research
purposes only. If tangible property is provided by UNIVERSITY to
LICENSEE, UNIVERSITY reserves the right to make, use and provide
tangible property and to grant nonexclusive licenses to make and use
such tangible property to third parties for noncommercial research
purposes only. In addition, the inventions claimed in the Licensed
Patents were made with the use of funds from the United States
government. Therefore, the U.S. Government has a paid-up,
royalty-free, nontransferable, worldwide, irrevocable license for
government use to practice or have practiced by or on behalf of the
U.S. Government the Licensed Patents. The U.S. Government has certain
other rights under 35 USC 200 et seq. and applicable regulations.
4. LICENSE FEES, ROYALTIES, AND OTHER PAYMENTS.
A. Upfront Fee. As partial consideration for the license granted in
Section 3 of this Agreement, LICENSEE made a payment in full in
December 2004 for one hundred and seventy-five thousand U.S. dollars
($175,000). LICENSEE is not obligated to make any further payment upon
execution of this Agreement.
1. Equity. As partial consideration for the license granted in
Section 3 of this Agreement, LICENSEE previously issued 53,462
shares of Opexa common stock to UNIVERSITY. LICENSEE is not
obligated to issue any additional shares or any other securities
to UNIVERSITY.
B. License Maintenance Fees. LICENSEE shall pay UNIVERSITY twenty
thousand U.S. dollars ($20,000) annually (the "Annual Maintenance
Fee"). The first Annual Maintenance Fee will be due on December 31,
2010, and on each December 31st thereafter until the earlier of the
filing of an Investigational New Drug Application (IND) or the fifth
anniversary of the Effective Date.
C. Milestone Payments. LICENSEE shall immediately notify UNIVERSITY when
the following events are accomplished by either LICENSEE, Sublicensee
and/or Affiliates of either, upon which LICENSEE will pay to
UNIVERSITY the following amounts:
The sums due and payable under this Section are nonrefundable and
noncreditable against Royalties except that if LICENSEE makes its
first Sale of an FDA-approved, Licensed Product or Licensed Method
prior to December 31, 2014, [*] of the [*] Milestone Payment in
Section 4.C.iii shall be creditable against Royalties.
D. Royalties. As partial consideration for the license granted in Section
3 of this Agreement, LICENSEE shall pay UNIVERSITY a Royalty of [*] of
Net Sales of Licensed Product(s) and/or Licensed Method(s) by
LICENSEE, its Sublicensee(s) and Affiliate(s) of either. The Royalty
obligation under this Section shall apply upon first Sale of a
Licensed Product(s) and/or Licensed Method(s) whether by LICENSEE or
Sublicensee or Affiliates of either. Royalty payments shall be due
quarterly and payable within thirty (30) days of the end of each
Calendar Quarter beginning in the period in which the first Sale
occurs.
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E. Minimum Royalties. If the total Royalties for any Calendar Year,
beginning with the first full Calendar Year following the first Sale
of Licensed Product(s) and/or Licensed Method(s) by LICENSEE,
Sublicensee(s), or Affiliate(s), are less than:
i. [*] for the first two years,
ii. and [*] for each year thereafter for the life of the Agreement
LICENSEE shall pay UNIVERSITY the difference between such amount and
the actual Royalties due. Such payment shall be made at the same time
payment for Royalties for the fourth quarter for such year is due.
F. Royalty Offset. In the event that, with respect to Net Sales of
Licensed Products and/or Licensed Methods, LICENSEE is paying
royalties to unaffiliated third parties for patent rights to make, use
or sell Licensed Product(s) and/or Licensed Method(s), the Royalties
due and payable to UNIVERSITY hereunder shall be proportionally
reduced by amounts paid to third parties for licenses. In no event
shall the Royalty payable to UNIVERSITY be less than [*]. A
Sublicensee shall not be entitled to a Royalty Offset under this
Section 4.F for any third party licenses it requires.
G. Calculation of Royalties. Royalties shall be payable in U.S. currency
within thirty (30) days after the end of each Calendar Quarter for the
Term of the Agreement, beginning with the Calendar Quarter in which
the first Sale of a Licensed Product(s) and/or Licensed Method(s)
occurs. A royalty statement showing Net Sales for each country and a
calculation of the Royalties due shall accompany each payment. Any
necessary conversion of currency into United States dollar shall be at
the applicable rate of exchange of Citibank, N.A., in New York, New
York, on the last day of the Calendar Quarter in which such
transaction occurred.
Each payment shall be accompanied by a statement, verified and signed
by the President or Chief Financial Officer of LICENSEE and certified
as accurate, showing Net Sales for each country in the Territory and
calculation of the Royalties due (Royalty Report).
H. Sublicense Revenue. For each sublicense granted by LICENSEE, LICENSEE
shall pay to UNIVERSITY [*] of all compensation of any type received
by LICENSEE in consideration of sublicense. For the purpose of this
Section, the term "compensation" shall not include (i) Royalties; (ii)
payments corresponding to Milestone Payments under Section 4.C; (iii)
payments and contributions of equipment, materials, and/or services
for research, (iv) reimbursement of expenses in connection with the
prosecution, maintenance or defense of patents or other intellectual
property, or (v) payments for capital stock or other securities up to
the fair market value of such stock or securities; any amounts in
excess of fair market value will be deemed to constitute
"compensation" under this Section 4.H.
I. Overdue Payment. Payments due to UNIVERSITY under this Agreement
shall, if not paid when due under the terms of this Agreement, bear
simple interest at the prime rate of interest (as published by
Citibank, N.A. on the date such payment is due) plus five percent
(5%), calculated on the basis of a three hundred sixty (360) day year
for the number of days actually elapsed, beginning on the due date and
ending on the day prior to the day on which payment is made in full.
Interest accruing under this Section shall be due UNIVERSITY on demand
or upon payment of past due amounts, whichever is sooner. The accrual
or receipt by UNIVERSITY of interest under this Section shall not
constitute a waiver by UNIVERSITY of any right it may otherwise have
to declare a default under this Agreement or to terminate this
Agreement. Time is of the essence with respect to all payments made by
LICENSEE to UNIVERSITY.
J. Licensee Enforcement of Sublicenses. LICENSEE shall use commercially
reasonable efforts to enforce the terms of its sublicense agreements
including terminating sublicenses for default in payment of Royalties.
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K. Full and Accurate Records. UNIVERSITY may from time to time and at any
reasonable time, not exceeding once every twelve (12) months, through
individuals as UNIVERSITY may designate, inspect the books and records
of LICENSEE and its Affiliates in order to verify the accuracy of any
reported statement by LICENSEE of sums paid or payable, or of any
other material obligation under this Agreement. LICENSEE shall keep,
and shall cause its Affiliates and Sublicensees to keep, full and
accurate books and records in sufficient detail so that LICENSEE's
compliance with its obligations under this Agreement can be properly
determined without undue delay or difficulty. Such books and records
shall be maintained for at least five (5) years after the Royalty
reporting period(s) to which they relate. Books and records shall
include but not be limited to: accounting general ledgers;
invoice/sales registers; original invoice and shipping documents;
federal and state business tax returns; LICENSEE financial statements;
sales analysis reports; inventory and or manufacturing records;
sublicense and distributor agreements; price lists, product catalogs
and other marketing materials. All such information shall be treated
as confidential pursuant to Section 8.
After completion of any such examination, UNIVERSITY shall notify
LICENSEE in writing of any proposed modification to LICENSEE's
statement of sums due and payable. Such examination shall be made at
the expense of UNIVERSITY, unless such examination discloses a
discrepancy of five percent (5%) or more in the amount of Royalties
and other payments due UNIVERSITY. In such case LICENSEE shall be
responsible for reimbursing UNIVERSITY for the examination fee and
expenses charged by the auditor. Any underpayment as determined by the
auditor will bear interest at five percent (5%) per month from the
date the royalty payment was due. LICENSEE agrees to pay past due
royalties for any royalty deficiency error, including any royalty
deficiency for periods prior to the period under audit. No other
confidentiality agreement shall be required to conduct the audit of
the LICENSEE's books and records.
5. DILIGENCE PROVISIONS.
A. Development Plan. By December 31st of each year after the Effective
Date of the Agreement until first Sale, LICENSEE shall provide the
UNIVERSITY with a plan for development, registration, and commercial
positioning of Licensed Product(s). Such summary shall include
statements regarding research and development plans and expenditures,
product milestones and related timetable schedules, government or
regulatory timetables, market entry timetables, and sales and
marketing plans and related financial data and the number of
person-equivalents committed to these efforts.
B. Human Clinical Trials. If LICENSEE fails to begin human clinical
trials of a Licensed Product(s) or Licensed Method(s) by December 31,
2011, UNIVERSITY shall have the right to unilaterally terminate this
Agreement. Such termination shall be effective thirty days (30) after
written notice to LICENSEE.
C. Notification of First Sale. LICENSEE agrees to immediately notify
UNIVERSITY in writing when Sales of Licensed Product(s) and/or
Licensed Method(s) first occur, at which time LICENSEE's obligation to
make Royalty payments begins.
D. Commercialization Plan. LICENSEE agrees to use its best commercially
reasonable efforts to prepare for the launch of Licensed Product(s)
and/or Licensed Method(s). No less than twelve (12) months prior to
the projected launch of Licensed Product(s) and/or Licensed Method(s)
and by December 31 of the first three full years following first Sale,
LICENSEE agrees to provide UNIVERSITY a commercial plan for the
marketing and sale of Licensed Product(s) and/or Licensed Method(s).
UNIVERSITY shall keep all commercialization plans and related
documents confidential pursuant to Section 8 hereof.
6. PATENT PROSECUTION AND MAINTENANCE.
A. Prosecution and Maintenance. UNIVERSITY shall be solely responsible
for the preparation, filing, prosecution and maintenance of the
Licensed Patents. LICENSEE agrees to cooperate, and agrees to cause
its Sublicensees and Affiliates of either to cooperate, with
UNIVERSITY in preparation, filing, prosecution and maintenance of the
Licensed Patents by disclosing such information as may be necessary
for the same and by promptly executing such documents as UNIVERSITY
may reasonably request in connection therewith. LICENSEE and its
Sublicensees and Affiliates of either shall bear their own costs in
connection with their cooperation with UNIVERSITY under this Section.
UNIVERSITY will provide LICENSEE copies of all material documents
received or prepared by UNIVERSITY in prosecution and maintenance of
Licensed Patents. UNIVERSITY shall provide copies in a timely manner
to allow LICENSEE an opportunity to comment and request changes.
UNIVERSITY shall reasonably include comments of LICENSEE in the
prosecution of Licensed Patents.
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B. Patent Costs. LICENSEE agrees to pay all necessary and reasonable
third party fees and expenses incurred by UNIVERSITY in obtaining and
maintaining the Licensed Patents, including those incurred by
UNIVERSITY prior to the Effective Date of this Agreement. Payment for
fees and expenses incurred after the Effective Date shall be invoiced
to LICENSEE on a monthly basis and LICENSEE agrees to pay such
invoices within thirty (30) days of receipt. LICENSEE shall raise any
objections to such amounts invoiced within the thirty (30) day time
period for payment.
C. Election Not to Pay Patent Costs. If LICENSEE decides to no longer
support patent costs for a specific Licensed Patent listed in Schedule
A, or a particular jurisdiction for a specific Licensed Patent listed
in Schedule A, or a particular issued or pending patent application
claiming priority to a Licensed Patent listed in Schedule A, LICENSEE
shall notify UNIVERSITY in writing. Upon receipt of such notice, the
patent rights at issue will thereafter be excluded from the license
granted hereunder, and UNIVERSITY shall be free to license such rights
to third parties, without any further obligation to LICENSEE. LICENSEE
shall continue to reimburse UNIVERSITY for all costs incurred up to
the date fourteen (14) days after the date of receipt of notice that
UNIVERSITY cannot reasonably avoid.
D. Failure to Pay Patent Costs. If LICENSEE declines or fails to make
advance payments or pay or reimburse UNIVERSITY for all or any portion
of the patent fees and expenses as required by Section 6.B for any
Licensed Patent, LICENSEE's rights with respect to all such
applications and patents for which LICENSEE fails to make advance
payments or does not reimburse UNIVERSITY shall terminate effectively
thirty (30) days after written notice from UNIVERSITY requesting such
payment, unless payment is made in full within such time. Upon such
termination of patent rights, the patent rights at issue will
thereafter be excluded from the license granted hereunder, and
UNIVERSITY shall be free to license such rights to third parties,
without any further obligation to LICENSEE. Not withstanding the
foregoing, failure to pay patent costs hereunder is a material breach
of this Agreement and the UNIVERSITY has the right to terminate the
Agreement as defined in Section 11.B.
7. WARRANTIES; INDEMNIFICATION, ASSUMPTION OF RISK; INSURANCE.
A. Disclaimers of Warranties. UNIVERSITY MAKES NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, UNDER THIS AGREEMENT. IN
PARTICULAR, UNIVERSITY DISCLAIMS ANY WARRANTY WITH RESPECT TO THE
INVENTION(S) CLAIMED IN LICENSED PATENTS OR WITH RESPECT TO THE
LICENSED PATENTS THEMSELVES, INCLUDING BUT NOT LIMITED TO, ANY
REPRESENTATIONS OR WARRANTIES ABOUT (i) THE VALIDITY, SCOPE OR
ENFORCEABILITY OF ANY OF THE LICENSED PATENTS; (ii) THE ACCURACY,
SAFETY OR USEFULNESS FOR ANY PURPOSE OF ANY INFORMATION PROVIDED BY
UNIVERSITY TO LICENSEE, ITS SUBLICENSEES OR AFFILIATES OF EITHER, WITH
RESPECT TO THE INVENTION(S) CLAIMED IN THE LICENSED PATENTS OR WITH
RESPECT TO THE LICENSED PATENTS THEMSELVES AND ANY PRODUCTS DEVELOPED
FROM OR COVERED BY THEM; (iii) WHETHER THE PRACTICE OF ANY CLAIM
CONTAINED IN ANY OF THE LICENSED PATENTS WILL OR MIGHT INFRINGE A
PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT OWNED OR LICENSED BY A
THIRD PARTY; (iv) THE PATENTABILITY OF ANY INVENTION CLAIMED IN THE
LICENSED PATENTS; OR (v) THE ACCURACY, SAFETY OR USEFULNESS FOR ANY
PURPOSE OF ANY PROCESS MADE OR CARRIED OUT IN ACCORDANCE WITH OR
THROUGH THE USE OF LICENSED PATENTS. IN ADDITION, UNIVERSITY
SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
B. Indemnification. LICENSEE agrees, and agrees to cause any Sublicensee
and Affiliates of either to, indemnify, defend and hold harmless
UNIVERSITY, Affiliates, and all trustees, directors, officers,
employees, fellows and agents of any of the foregoing (collectively
the "Indemnified Persons") from and against any and all claims,
demands, loss, damage, penalty, cost or expense (including attorneys'
and witnesses' fees and costs) of any kind or nature, arising out of,
or otherwise relating to this Agreement, including without limitation
(i) any claims arising from the development, production, use, sale,
license or other disposition of Licensed Product(s) and/or Licensed
Method(s) and all activities associated therewith, or (ii) any use of
information provided by UNIVERSITY to LICENSEE, its Sublicensees or
Affiliates of either. LICENSEE agrees, and agrees to cause each of its
Sublicensees and Affiliates of either to agree not to sue any
Indemnified Person in connection with the development, production,
use, sale or other disposition of the Licensed Product(s) or Licensed
Method(s) and all activities associated therewith. UNIVERSITY shall be
entitled to participate at their option and expense through counsel of
their own selection, and may join in any legal actions related to any
such claims, demands, losses, damages, costs, expenses and penalties.
LICENSEE, its Sublicensees and Affiliates of either, shall not enter
into any settlement affecting any rights or obligations of any
Indemnified Person or which includes an express or implied admission
of liability, negligence or wrongdoing by any Indemnified Person,
without prior written consent of such Indemnified Person.
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C. Assumption of Risk. The entire risk as to the performance, safety, and
efficacy of Licensed Products, Licensed Methods, or any invention
claimed in the Licensed Patents is assumed by LICENSEE, its
Sublicensees and Affiliates of either. Indemnified Persons shall not,
except for their intentional misconduct or gross negligence, be
responsible or liable for any injury, loss, or damage of any kind,
including but not limited to direct, indirect,, any Sublicensee,
Affiliates of either or customers or any person or entity, regardless
of legal theory for any activity undertaken in connection with this
Agreement, Licensed Patents, Licensed Methods, or Licensed Products
and all activities associated therewith. The above limitations on
liability apply even though the Indemnified Person may have been
advised of the possibility of such injury, loss or damage. LICENSEE
shall not and shall cause its Sublicensees and Affiliates of either to
not, make any agreements, statements, representations or warranties or
accept any liabilities or responsibilities whatsoever with regard to
any person of entity, which are inconsistent with this Section 7.C.
D. Insurance. LICENSEE agrees, and agrees to cause its Sublicensees and
Affiliates of either to agree, to maintain liability insurance that
shall cover any claims from bodily injury, property, or other damage
alleges to relate to Licensed Products, Licensed Methods, or
activities undertaken in connection with this Agreement, Licensed
Patents, Licensed Methods, or Licensed Products, including the
development, manufacture, use, sale or other disposition of Licensed
Products and/or Licensed Methods and all activities associated
therewith. LICENSEE, Sublicensees, Sublicensees' or Affiliates'
expense, whichever is relevant, as additional named insureds under
each liability insurance policy (including excess or umbrella
liability policies) that LICENSEE, its Sublicensees and Affiliates of
either have or shall obtain, that includes any coverage of claims
relating to Licensed Products and/or Licensed Methods. Such insurance
shall be primary and noncontributory to any insurance UNIVERSITY and
its Affiliates may have. At UNIVERSITY's request, LICENSEE will supply
UNIVERSITY in writing at least thirty (30) days prior to any
termination of or change in coverage under any such policies.
8. CONFIDENTIAL INFORMATION AND PUBLICATION.
A. All information submitted by one Party to the other concerning
Licensed Product(s), Licensed Method(s), and/or the invention(s)
claimed in the Licensed Patents shall be considered confidential
("Confidential Information") and shall be utilized by the receiving
Party only pursuant to the licenses granted hereunder. During the term
of this Agreement and for a period of five (5) years thereafter,
neither Party shall disclose to any third party any Confidential
Information received from the other Party without the specific written
consent of such Party. The foregoing shall not apply where
Confidential Information a) was or becomes public through no fault of
the receiving Party, b) was, at the time of receipt, already in the
possession of the receiving Party as evidenced by its written records,
c) was obtained from a third party legally entitled to use and
disclose the same, or d) is required by law to be disclosed to a
governmental agency.
B. UNIVERSITY agrees to preserve as confidential any and all trade
secrets, privileged records or other proprietary information belonging
to LICENSEE, marked as Confidential and disclosed to the UNIVERSITY.
For disclosure of proprietary information belonging to LICENSEE by
oral communication, such disclosure will be reduced to writing, marked
as Confidential, and sent to UNIVERSITY within two (2) weeks
disclosure to UNIVERSITY.
C. LICENSEE acknowledges the UNIVERSITY's strong institutional policy
favoring the retention of public rights and dependence upon
publication as essential means of exchange. UNIVERSITY shall have the
right to publish the results of and disseminate information to the
extent that proprietary trade secrets or confidential information
provided by LICENSEE to UNIVERSITY are not disclosed.
9. MARKETING AND ADVERTISING. Each Party agrees not to use the name of the other
Party in any commercial activity, press releases, marketing, advertising or
sales brochures except with the prior written consent of the other Party, which
consent may be granted or withheld in such Party's sole discretion. LICENSEE
further agrees not to use and shall prohibit its Sublicensees and Affiliates of
either from using the name of the University of Chicago or Argonne National
Labs, in any commercial activity without the prior written consent of the
UNIVERSITY. LICENSEE may, upon receiving approval from UNIVERSITY, apply such
approval to subsequent iterations of the same activity provided that the content
and presentation of the approved material is not changed in terms of scope,
scale, or purpose. For additional clarification by example, it is intended that
for approved material used in presenting to potential investors of LICENSEE the
approved material may be presented to several investors at different times
without need for approval of each presentation.
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10. INFRINGEMENT.
A. Notice of Infringement. In the event of an infringement of a Licensed
Patent, each Party shall give the other written notice if one of them
becomes aware of any infringement by a third party of any Licensed
Patent. Upon notice of any such infringement, the parties shall
promptly consult with one another with a view toward reaching the
agreement on a course of action to be pursued.
B. LICENSEE's Right to Bring Infringement Action. If a third party
infringes any patent included in Licensed Patents within the Field,
LICENSEE shall have the right to institute and prosecute an action or
proceeding to abate such infringement and to resolve such matter by
settlement or otherwise with the permission of UNIVERSITY. Before
LICENSEE commences an action with respect to an infringement of such
patents, LICENSEE shall give careful consideration to the views of
UNIVERSITY and to potential effects on the public interest in making
its decision whether or not to sue. LICENSEE agrees to notify
UNIVERSITY of its intention to bring an action or proceeding prior to
filing the same within thirty (30) days after notification under
Section 10.A. LICENSEE agrees to hire counsel reasonably acceptable to
UNIVERSITY. LICENSEE shall keep UNIVERSITY timely informed of material
developments in the prosecution or settlement of such action or
proceeding. LICENSEE shall be responsible for all costs and expenses
of any action or proceeding against infringers, which LICENSEE
initiates. UNIVERSITY may be represented by counsel in any such legal
proceedings acting in an advisory but not controlling capacity, the
expense of which shall be subject to reimbursement by LICENSEE.
UNIVERSITY shall cooperate fully by joining as a party plaintiff if
required to do so by law to maintain such action or proceeding and by
executing and making available such documents as LICENSEE may
reasonably request. LICENSEE agrees to promptly reimburse UNIVERSITY
for its reasonable third party out-of-pocket fees and expenses
incurred in joining an action or proceeding or cooperating with
LICENSEE. All amounts of every kind and nature recovered from an
action or proceeding of infringement by LICENSEE shall belong to
LICENSEE. After deduction of fees and expenses of both parties to this
Agreement, any remaining amounts recovered shall be considered Net
Sales under this Agreement and subject to Royalty payments in
accordance with Section 4.D.
C. LICENSEE Discretion. The prosecution, settlement, or abandonment of
any action or proceeding under Section 10.B shall be at LICENSEE's
reasonable discretion provided that LICENSEE has timely informed
UNIVERSITY of material developments of such action. LICENSEE shall not
have any right to surrender any of UNIVERSITY's rights to the Licensed
Patents or Licensed Methods, or to grant any infringer any of
UNIVERSITY's rights to the Licensed Patents or Licensed Methods
without UNIVERSITY's written consent.
D. UNIVERSITY's Right to Bring Infringement Action. If LICENSEE declines
or fails to take action to abate an infringement within thirty (30)
days of notification under Section 10.A, UNIVERSITY shall have the
right, at its sole discretion, to take action, including to institute
and prosecute an action or proceeding, to abate such alleged
infringement and to resolve such matter by settlement or otherwise.
LICENSEE shall cooperate fully by joining as a party plaintiff if
required to do so by law to maintain such action and by executing and
making available such documents as UNIVERSITY may reasonably request.
If the amounts recovered by UNIVERSITY exceed its reasonable third
party fees and expenses, UNIVERSITY agrees to pay LICENSEE for its
reasonable third party expenses incurred by it in cooperating in the
action or proceeding. Except as specifically provided in this Section
10.D, UNIVERSITY shall have the right to retain all amounts recovered
of every kind and nature. Amounts recovered by UNIVERSITY shall not be
considered Net Sales under this Agreement and shall not be construed
to affect LICENSEE's rights under this Agreement to sublicense the
Licensed Patents and/or Licensed Methods provided, however, that once
the UNIVERSITY has instituted legal proceedings against, or settlement
discussions with, an alleged infringer under this Section 10.D,
LICENSEE shall not grant a sublicense to such alleged infringer
without the prior written consent of UNIVERSITY.
Page 8 of 12
11. TERM AND TERMINATION.
A. Term. Unless terminated earlier pursuant to Section 11.B or 11.C of
this Agreement, this Agreement shall terminate on the date of
expiration of the last to expire of the Licensed Patents.
B. UNIVERSITY's Right to Terminate. UNIVERSITY shall have the right to
terminate this Agreement as follows, in addition to all other
available remedies:
1) If LICENSEE fails to pay any Royalties, Patent Costs or other
payment when due, this Agreement shall terminate effective ninety
(90) days after UNIVERSITY's written notice to LICENSEE to such
effect, unless LICENSEE makes such payment within the ninety (90)
days or has cured such failure to the satisfaction of the
UNIVERSITY.
2) If LICENSEE fails to comply with any material obligation of this
Agreement other than an obligation to make a Royalty or other
payment when due, the UNIVERSITY may at its sole discretion
terminate the Agreement effective ninety (90) days after
UNIVERSITY's written notice to LICENSEE describing such failure,
unless LICENSEE cures such failure to the satisfaction of
UNIVERSITY within the ninety (90) days.
3) If LICENSEE shall have filed by or against it a petition under
any bankruptcy or insolvency law and such petition is not
dismissed within ninety (90) days of its filing, or if LICENSEE
makes an assignment of all or substantially all of its assets for
the benefit of its creditors UNIVERSITY may terminate this
Agreement by written notice effective as of the (i) date of
filing by LICENSEE of any such petition, (ii) date of any such
assignment to creditors, or (iii) end of the ninety (90) days if
a petition is filed against it and not dismissed by such time,
whichever is applicable.
4) If LICENSEE shall be dissolved, liquidated or otherwise ceases to
exist, other than for reasons specified in this Section 11, this
Agreement shall automatically terminate as of (i) the date
articles of dissolution or a similar document is filed on behalf
of LICENSEE with the appropriate government authority or (ii) the
date of establishment of a liquidating trust or other arrangement
for the winding up of the affairs of LICENSEE. Any previous
waiver by the UNIVERSITY, of the UNIVERSITY's right to terminate
this Agreement, shall not constitute a waiver on any subsequent
right of the UNIVERSITY to terminate under this Section 11.
5) UNIVERSITY shall have the right to immediately terminate this
Agreement in the event that LICENSEE challenges, directly or
indirectly, the validity or enforceability of any of the Licensed
Patents before any court, arbitrator, or other tribunal or
administrative agency in any jurisdiction. Notwithstanding the
foregoing, UNIVERSITY will not have the right to terminate this
Agreement on account of any action taken by LICENSEE in
connection with its prosecution or defense of (i) LICENSEE's
owned intellectual property or (ii) third-party intellectual
property controlled by LICENSEE.
C. LICENSEE's Right to Terminate. LICENSEE may terminate this Agreement
at any time by giving UNIVERSITY ninety (90) days prior written
notice.
D. Post Termination Obligations of LICENSEE. Upon the termination of this
Agreement pursuant to Section 11.B or 11.C, all rights of LICENSEE to
use the Licensed Patent(s) and Licensed Method(s), and any other
rights conferred to LICENSEE by this Agreement, shall immediately
thereafter cease. Upon such termination, and upon request of
UNIVERSITY, all Tangible Materials shall be either transferred to
UNIVERSITY or destroyed in part or in whole by LICENSEE; provided
LICENSEE may elect to destroy biological materials in lieu of
transferring them to UNIVERSITY. LICENSEE shall provide to the
UNIVERSITY a certification that such partial or complete destruction
has been completed. LICENSEE shall not thereafter operate or conduct
business under any name or mark and in any manner in the Territory
that might tend to create the impression that this Agreement is still
in force, or that LICENSEE has any right to use any Licensed
Patent(s), Licensed Method(s), any trademark or servicemark of
UNIVERSITY, and/or any Tangible Material. All payments including fees
and costs due under this Agreement and not paid yet shall become
immediately due and payable. Upon expiration or termination, LICENSEE
shall cease using UNIVERSITY's name.
Page 9 of 12
E. Survival. All causes of action accruing to either party under this
Agreement shall survive termination for any reason, as well as (1)
LICENSEE'S obligation to pay Royalties, Patent Costs, fees and other
payments accrued prior to the date of termination and which were not
paid or payable before termination, and (2) LICENSEE obligation to
report Net Sales and to keep records as set forth in this Agreement,
and (3) all provisions inclusive from Section 7 to Section 10 survive
termination or expiration of the Agreement. During the six (6) month
period following termination of this Agreement, LICENSEE may sell
inventory existing or in the process at the time of termination. Such
Sales shall be subject to the Royalty obligations under Section 4.D.
F. Termination and Sublicenses. If UNIVERSITY terminates this Agreement
for any reason, UNIVERSITY shall provide to each Sublicensee written
notice of the termination at the address specified in their
Sublicense. UNIVERSITY agrees that upon the Sublicensee's notice as
described below and provided the Sublicensee is not in breach of its
Sublicense, UNIVERSITY shall grant to such Sublicensee license rights
and terms equivalent to the Sublicense rights and terms which the
Sublicense shall have granted to the Sublicensee; provided that
Sublicensees within sixty (60) days of receiving the notice of
termination provides to UNIVERSITY written notice wherein the
Sublicensee: (i) agrees to abide by the terms and conditions of this
Agreement applicable to LICENSEE and to discharge directly all
pertinent obligations of LICENSEE hereunder; provided that if the
payments of Sublicensee pursuant to the terms of the Sublicense are
greater than the payments owed under this Agreement, Sublicensee's
royalty and other payment obligations shall be modified to match those
of the Sublicense, and (ii) acknowledges that UNIVERSITY shall have no
obligations to the Sublicensee other than its obligations set forth in
this Agreement with regard to LICENSEE.
12. EXPORT REGULATIONS. Licensed Products, Licensed Methods, and technical data
and information delivered under this Agreement may be subject to United States
export control laws and may also be subject to export or import regulations in
other countries. LICENSEE agrees to comply strictly with all such laws and
regulations and acknowledges that LICENSEE has the responsibility to obtain such
licenses to export, re-export, or import Licensed Products, Licensed Methods, or
other technical data and information delivered under this Agreement as may be
required by applicable laws or regulations. To the extent that the United States
Export Control Regulations are applicable, neither LICENSEE nor UNIVERSITY
shall, without having first fully complied with such regulations, (i) knowingly
transfer, directly or indirectly, any unpublished technical data obtained or to
be obtained from the other party hereto to any destination, or (ii) knowingly
ship, directly or indirectly, any product produced using such unpublished
technical data to any destination. LICENSEE acknowledges that the export of any
products and/or technical data from the United States may require some for of
export control licenses by LICENSEE may result in LICENSEE subjecting itself to
criminal liability under U.S. laws.
13. U.S. COMPETITIVENESS. LICENSEE agrees that any Licensed Product(s) any/or
Licensed Method(s) for use or sale in the United States shall be manufactured
substantially in the United States as required by 35 United States Code Section
204.
14. ENTIRE AGREEMENT, AMENDMENT, WAIVER. The Agreement together with the
Schedule attached hereto constitute the entire agreement between the Parties
regarding the subject matter hereof, and supersedes all prior written or oral
agreements or understandings (express or implied) between them concerning the
same subject matter. The Agreement may not be amended or modified except in
writing signed by duly authorized representatives of each Party. No waiver of
any default hereunder by either Party or any failure to enforce any rights
hereunder shall be deemed to constitute a waiver of any subsequent default with
respect to the same or any other provision hereof.
15. NOTICE. Any notice required or otherwise made pursuant to this Agreement
shall be in writing, sent by registered or certified mail properly addressed, or
by facsimile with confirmed answer-back, to the other Party at the address set
forth below or at such other address as may be designated by written notice to
the other Party. Notice shall be deemed effective three (3) business days
following the date of sending such notice if by mail, on the day following
deposit with an overnight courier, or upon confirmed answer-back if by
facsimile.
IF to UNIVERSITY: IF to LICENSEE:
University of Chicago
UChicagoTech, Attn: Director David B. McWilliams, President
5555 S. Woodlawn Ave., 2635 N. Crescent Ridge Drive
Suite 300 The Woodlands, TX 77381
Chicago, IL 60637
Page 10 of 12
16. ASSIGNMENT. This Agreement shall be binding on the Parties hereto and upon
their respective successors and assigns. Notwithstanding Section 3.A, either
Party may at any time, upon written notice to the other Party, assign or
delegate to a successor to all or substantially all of its business any of its
rights and obligations hereunder, provided that any such assignment or
delegation shall in no event relieve either Party of its primary responsibility
for the same. Except as provided in the preceding sentence, and except as
provided in Section 11.B(3), LICENSEE may not assign this Agreement without the
prior written consent of UNIVERSITY, which consent shall not be unreasonably
withheld, and any attempted assignment in violation thereof shall be void.
UNIVERSITY may assign this Agreement at any time to any third party on written
notice to LICENSEE. In such event, the assignee shall be substituted for
UNIVERSITY as a party hereto, and UNIVERSITY shall no longer be bound hereby.
17. GOVERNING LAW. To the extent there is no applicable federal law, the
interpretation and performance of this Agreement shall be governed by the laws
of the State of Illinois applicable to contracts made and to be fully performed
in that state.
18. COUNTERPARTS. This Agreement may be executed in several counterparts, each
of which shall be deemed an original and all of which shall constitute on and
the same document.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their respective duty authorized officers or representatives and signed
below,
University of Chicago Opexa Therapeutics
By: /s/ Alan Thomas By: /s/ David B. McWilliams
Name: Alan Thomas Name: David B. McWilliams
Title: Director, UChicagoTech Title: President
Date: July 31, 2007 Date: July 31, 2007
Page 11 of 12
SCHEDULE A
UChicagoTech Case #ANL-02-021
US Patent Application - 10/704,110, title "Human stem cell materials and
methods"
Nationalized PCT applications: 03781813.5EPO; 2,505,394 CA
Page 12 of 12