EXCLUSIVE LICENSE AGREEMENT Between Washington University Licensor and Modigene, Inc. Licensee
Between
Washington
University
Licensor
and
Modigene,
Inc.
Licensee
Introduction: This
Exclusive License Agreement (“Agreement”) is made and entered into on the
Effective Date by and between The Washington University, a corporation
established by special act of the Missouri General Assembly, approved February
22, 1853 and acts amendatory thereto, having its principal office at Xxx
Xxxxxxxxx Xxxxx, Xx. Xxxxx, Xxxxxxxx 00000 (hereinafter "WU" or “Licensor”), and
Modigene, Inc. , a company incorporated in Delaware and having a principal
office at 0000
Xxxxxx Xxxxxxxx Xxxxx, Xxxxx 0000, Xxxxxx, XX 00000
(hereinafter "Modigene" or “Licensee”).
1. Background. WU
is the
owner of certain Patent Rights, to which WU has the sole and exclusive right
to
grant licenses and sub-licenses. WU wishes to allow the Patent Rights to be
used
to further scientific research and for new product development and other
applications in the public interest and is willing to grant a license. The
Non-Exclusive License Agreement was subsequently amended on January 3, 2002
(the
“First Amendment”). A Binding Term Sheet (the “Term Sheet”) for an exclusive
license agreement was executed on December 27, 2005 between the Parties. This
Agreement replaces, cancels and supersedes the Non-Exclusive License Agreement,
First Amendment and Term Sheet, and all other agreements of the Parties
regarding any of the Patent Rights, whether or not such agreements were reduced
to writing, which are all hereby cancelled and as of the Effective Date of
this
Agreement are null and void. Modigene desires to obtain a license to use the
Patent Rights for its own commercial research and development endeavors upon
the
terms and conditions set forth in this Agreement. In consideration of these
premises and the mutual promises contained herein, the Parties further agree
as
follows.
2. Definitions. For
the
purposes of this Agreement, the following words and phrases will have the
meanings assigned to them below.
2.1 Affiliate: Any
person or entity that, as of the Effective Date, directly or indirectly, owns
or
Controls a Party or that is Controlled by or under common Control with a Party.
For purposes of this definition, “Control(s)” or “Controlled” means (a) direct
or indirect ownership of at least 50% of the outstanding voting securities
of a
corporation, or (b) the right to receive at least 50% of the earnings of the
person, corporation, or other entity in question.
2.2 Calendar
Half Year:
Each
six-month period, or portion thereof, beginning on January 1 or July
1.
2.3 Combination
Product: Any
product that is comprised in part of a Licensed Product and in part of one
or
more other human therapeutic compounds which are not themselves Licensed
Products (the "Other Agents"). Other Agents do not include surfactants,
diluents, carriers and other formulation, carrier, or non functional agents.
2.4 Development
Plan:
Modigene’s good faith, bona fide plan for the development, sale and/or marketing
of Licensed Products, as set forth in Exhibit B to this Agreement, and from
time
to time amended.
2.5 Effective
Date: February
2, 2007.
2.6 Field: Any
and
all human therapeutics, excluding any and all diagnostic applications and
veterinary therapeutics.
2.7 First
Commercial Sale:
The
earliest date on which Licensee or any of its Sublicensees transfers a Licensed
Product for compensation (including equivalent cash value for trades or other
non-cash payments) for end use of such Licensed Product in a country after
the
governing health regulatory authority of such country has granted regulatory
approval of such Licensed Product, to the extent such regulatory approval is
required in such country. The transfer of Licensed Products by Modigene, its
Affiliates or its Sublicensees strictly for their own laboratory research and
development purposes, beta-testing and/or clinical testing does not constitute
a
First Commercial Sale for the purposes of this Agreement.
2.8 IND:
An
Investigational New Drug application filed with the FDA pursuant to 21 CFR
312.1
et seq.
2.9 Licensee:
Includes
Modigene and its Affiliates.
2.10 Licensed
Product: Any
product made, made for, used, sold or imported by Licensee or any Sublicensees
that: (a) in the absence of this Agreement, the manufacture, use, sale, offering
for sale, or importation thereof would infringe at least one Valid Claim, or
(b)
uses a process covered by a Valid Claim. Licensed Products exclude all forms
and
derivatives of proteins with the biological activity of follicle-stimulating
hormone (“FSH”), luteinizing hormone (“LH”), thyrotropin or thyroid-stimulating
hormone (“TSH”), and human chorionic gonadotropin (“HCG”) that
have
been modified according to any Valid Claim.
2
2.11 The
Eleven Molecules:
The
following eleven (11) molecules that were named in the Non-Exclusive License
Agreement between WU and Modigene Tech which are: Erythropoietin, prourokinase,
growth hormone, interferon alpha2, interferon beta, granulocyte colony
stimulating factor (“GCSF”), GMCSF, Fab fragment of antibodies (human and
non-human), interleukin 11, angiostatin and endostatin.
2.12 The
Additional Molecules:
Any
proteins and peptides having a native or non-native amino acid sequence,
excluding all forms and derivatives of follicle-stimulating
hormone (“FSH”), luteinizing hormone (“LH”), thyrotropin or thyroid-stimulating
hormone (“TSH”), and human chorionic gonadotropin (“HCG”)
that are
agonistic or antagonistic.
2.13 Net
Sales:
Any and
all cash payments, value and compensation received by Modigene, its Affiliates
and Sublicensees from a Third Party for Sales of Licensed Products, less all
Permissible Deductions. Permissible Deductions are defined as and shall be
limited to the following:
|
2.13.1
|
Distributors
fees, trade, quantity and cash discounts, chargebacks, rebates or
allowances actually paid, granted, allowed or incurred in the ordinary
course of business on Licensed Products actually provided to Third
Parties.
|
|
2.13.2
|
Credits,
allowances or refunds, not to exceed the original invoice amount,
for
actual claims, damaged goods, rejections or returns of Licensed
Products.
|
|
2.13.3
|
Excise,
sale, use, customs brokers fees or customs duties, value added or
other
taxes, other than income taxes, paid by Licensee or its Sublicensees
due
to the Sale of Licensed Products.
|
|
2.13.4
|
Fees
paid to governmental agencies based on the sales volume (expressed
in
units or US dollars) or selling price of a Licensed Product, such
as
Medicaid rebates paid by the selling Party to Medicaid
authorities.
|
For
the
purpose of this definition, transfer of a Licensed Product, within Licensee
or
between Licensee and its Affiliates for subsequent Sale to a Third Party shall
not be considered a Sale until a Sale is made to a Third Party and the Net
Sales
shall be based on the Sale to the Third Party of such Licensed Product by
Licensee or its Affiliates. “Net
Sales” shall not include the amount received for any Licensed Products sold to
any Sublicensee unless such Sublicensee is an end-user of such Licensed Products
(i.e., Sublicensee’s purchase of Licensed Products is not for the purpose of
resale).
2.14 Party: WU
or
Modigene. Collectively, WU and Modigene may be referred to as the
“Parties.”
3
2.15 Patent
Rights: The
patents and patent applications listed in Exhibit
A,
attached
hereto and incorporated by reference herein, and all foreign counterparts,
continuations, divisions, extensions, reexaminations and reissues thereof,
which
claim their earliest priority filing date to a patent or patent application
listed in Exhibit
A.
2.16 Phase
II:
Has the
meaning set forth in 21 CFR 312.21(b), as amended.
2.17 Phase
III:
Has the
meaning set forth in 21 CFR 312.21(c), as amended.
2.18 Sale: Any
transaction with a Third Party end user in which a Licensed Product is exchanged
or transferred for cash, value and/or other compensation.
A Sale
of a Licensed Product will be deemed to have been made when such Licensed
Product is paid for and the purchase price is collected by Licensee or its
Affiliates.
2.19 Sublicensee: A
Third
Party to whom Modigene has granted a sublicense pursuant to and in accordance
with Article 3 of this Agreement.
2.20 Sublicensing
Revenue:
Any and
all cash, value, compensation and fees received by Licensee or its Affiliates
from a Sublicensee less taxes, duties or other governmental tariffs.
Notwithstanding the foregoing, the term “Sublicensing Revenue” shall
not
include
any monies (or equivalent value) received by Licensee or its Affiliates from
a
Sublicensee which is a payment in the form of: (a) royalties on sales to
Third Parties, and (b) equity
investments in Licensee, to the extent that such equity investments are not
directly in consideration of the sublicensing of any license granted
hereunder;
and (c)
support of Licensee’s or its Affiliates’ research, development or clinical
programs.
2.21 Term: Commencing
on the Effective Date and continuing until the expiration date of the last
to
expire Patent Rights listed in Exhibit A, unless earlier terminated in
accordance with this Agreement.
2.22 Territory:
means
worldwide.
2.23 Third
Party:
Any
person or entity other than a Party and such Party’s Affiliates.
2.24 Valid
Claim: A
claim
of an pending or issued and unexpired patent within the Patent Rights that
has
not been held invalid or unenforceable by a court or other governmental agency
of competent jurisdiction, which holding is not subject to appeal and which
claim has not been disclaimed.
3. License
Grant.
Subject
to the terms and conditions set forth in this Agreement, WU hereby grants to
Modigene and Modigene hereby accepts, the following license during the Term
in
the Territory:
4
3.1 An
exclusive, fee-bearing and royalty-bearing license, including the right to
grant
sublicenses as set forth herein, to the Patent Rights; and under the Patent
Rights, to make, have made, sell, have sold, offer for sale, use, and import
Licensed Products in the Field during the Term and within the Territory.
3.2 Licensee
may grant sublicenses under this Agreement only in strict compliance with the
following terms and conditions:
3.2.1 Only
Licensee is permitted to grant a sublicense, provided that: each sublicense
shall, for the express benefit of WU, bind the Sublicensee to terms and
conditions no less favorable to WU than those between WU and Modigene under
this
Agreement, and shall provide that WU receive earned royalties on Net Sales
made
by Sublicensee of Licensed Products in an amount no less than WU would receive
had the Net Sales been made by Licensee. To the extent that any term, condition,
or limitation of any sublicense agreement is inconsistent with this Agreement,
such term, condition, and/or limitation shall automatically be null and void
against WU without any action required by WU. Without in any way narrowing
or
limiting the scope of the foregoing provisions of this Subsection, any
sublicense granted by Modigene under this Agreement shall provide:
3.2.1(a)
That every Sublicensee shall indemnify and hold harmless WU Indemnitees (as
defined in Article 11) to the same extent and under terms no less favorable
to
WU Indemnitees as Modigene’s obligations under Article 11 of this
Agreement.
3.2.1(b)
That every Sublicensee shall maintain insurance for WU’s benefit to the same
extent and under terms no less favorable to WU as Modigene’s obligations under
Article 12 of this Agreement.
3.2.1(c)
That every Sublicensee shall maintain books and records and allow audits for
WU’s benefit to the same extent and under terms no less favorable to WU as
Modigene’s obligations under Section 6.4 of this Agreement.
3.2.1(d)
That, to the extent applicable, every Sublicensee of the products listed in
Exhibit B shall comply with the Development Plan set forth in Exhibit B and
referred to in Article 4 of this Agreement.
3.2.1(e)
That if Modigene enters bankruptcy or receivership, voluntarily or
involuntarily, Sublicensing Revenue then or thereafter due to Modigene by
Sublicensee will, upon notice from WU to any Sublicensee, become directly due
and owing to WU for the account of Modigene. WU will remit to Modigene any
amounts received that exceed the sum actually owed by Modigene to
WU.
3.2.1(f)
That any sublicense that is in full compliance with this Agreement, including
without limitation this Article 3 will remain in effect in the event that this
Agreement is terminated prior to expiration. Any Sublicensee will automatically
become a direct licensee of WU under the rights originally sublicensed to it
by
Modigene, provided that (i) the Sublicensee did not cause or assist in the
termination of this Agreement and (ii) the Sublicensee agrees to comply with
all
the terms of this Agreement and to fulfill all the responsibilities of Modigene
hereunder. In no event, however, shall a person or entity who becomes a direct
licensee pursuant to this provision have any right to grant sublicenses under
this Agreement.
5
3.2.2
Within thirty (30) days of the effective date of any sublicense, Modigene shall
provide WU a complete copy of the sublicense and all exhibits thereto. WU shall
retain such information in strict confidence in accordance with the provisions
of Section 7 below. If the original sublicense is written in a language other
than English, the copy of the sublicense and all exhibits thereto shall be
accompanied by a complete translation written in English. Modigene represents
and warrants that such translation will be a true and accurate translation
of
the sublicense agreement and its exhibits.
3.2.3
Modigene will be primarily liable to WU for all of Modigene's obligations and
sublicensee’s obligations contained in this Agreement.
3.3 The
license "to have made" granted in Sections 3.1 and 3.2 means that Modigene
may
contract with one or more Third Parties to manufacture Licensed Products for
Modigene for sale or offer for sale by Modigene or Sublicensees within the
scope
of its (or their) sales operations. Modigene shall require all such Third
Parties to assume confidentiality obligations consonant with Article 7 of this
Agreement.
3.4 For
academic research, education, and other non-commercial uses, WU retains all
rights to the Patent Rights and to use the Eleven Molecules and the Additional
Molecules. Modigene shall have a first option to exclusively license, in the
Field and for The Eleven Molecules and The Additional Molecules, any new patent
rights claiming improvements to the CTP technologies developed at WU, provided
that Modigene shall give WU written notice of excising such an option within
ninety (90) days from receiving written notice from WU of such new improvements
and patent applications. The terms and conditions of such an excusive license
shall be negotiated between the parties on a good faith basis.
3.5 If
any
Affiliate of Modigene exercises any rights under this Agreement, said Affiliate
shall be bound by all terms and conditions of this Agreement as if this
Agreement had been directly between WU and the Affiliate. Modigene shall remain
fully liable to WU for each of its Affiliates, such that all acts, omissions,
and obligations of each of Modigene’s Affiliates shall, for purposes of this
Agreement, be considered as acts, omissions, and obligations of
Modigene.
3.6 This
Agreement provides Modigene and Sublicensees no ownership rights of any kind
in
the Patent Rights. All ownership rights remain the property of WU.
6
3.7 In
accordance with Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C.
§§
200-212, the United States government retains certain rights to inventions
arising from federally supported research or development. Under these laws
and
implementing regulations, the government may impose requirements on such
inventions. Licensed Products embodying inventions subject to these laws and
regulations sold in the United States must be substantially manufactured in
the
United States. The license rights granted in this Agreement are expressly made
subject to these laws and regulations as they may be amended from time to time.
Modigene shall be required to abide by all such laws and regulations and shall
ensure that all sublicenses under this Agreement impose a similar requirement
upon all Sublicensees.
3.8
Licensee shall ensure that appropriate markings, such as “Patent Pending” or the
Patent Rights patent number or application serial number, appear, in accordance
with each country’s patent laws, on all Licensed Products (or their packaging,
as appropriate) sold by or on behalf of Licensee and all
Sublicensees.
4. Development.
Modigene
agrees to use its reasonable commercial efforts to develop, have developed,
and/or sell and/or have sold Licensed Products in accordance with the
Development Plan. Modigene also agrees that, if applicable, it will require
its
Sublicensees to comply with the standards and obligations of Modigene set forth
herein.
4.1 Licensee
represents and warrants that the Development Plan contains Licensee’s good
faith, bona fide plans for commercializing Licensed Products.
4.2 Modigene
will update the Development Plan and report progress against the Development
Plan in writing to WU no later than January 31 of the first two calendar years
following the calendar year in which the Effective Date falls, and no later
than
January 31 of each subsequent calendar year. The updates and reports will
summarize in reasonable detail the progress achieved and any problems
encountered in the development, prototyping, evaluation, testing, manufacture,
sale, and/or marketing of each Licensed Product. Upon reasonable request by
WU,
Modigene will consult with WU about tasks, schedules and progress.
4.3 Prior
to
the First Commercial Sale of each Licensed Product, Modigene will timely comply
with any and all terms of the Development Plan as agreed to and from time to
time amended by Licensee
4.4
Within
four(4) years after the First Commercial Sale of a Licensed Product, Modigene
will sell sufficient quantities of Licensed Products such that the earned
royalties equal or exceed the minimum royalty payments required under Article
5.
4.5 Should
WU
conclude in its reasonable judgment that Modigene has not met its development
obligations in this Section 4 for reasons other than: (a) a governmental agency
has withheld/delayed regulatory approval and/or requires additional studies
and
materials notwithstanding Modigene’s diligent efforts to obtain such approval;
or (b) Modigene encountered unanticipated technical or scientific and/or
manufacture problems not withstanding its diligent efforts to correct or address
such problems as evidenced by contemporaneous written records; or (c) Modigene
encountered other causes beyond its reasonable control, notwithstanding its
diligent efforts to overcome them, and as evidenced by contemporaneous written
records; then WU may notify Modigene of its conclusions in writing and the
basis
therefore and, upon request of WU, Modigene must show cause why the license
granted hereunder should not be terminated. If within ninety (90) days after
Modigene’s receipt of WU's service of notice the Parties have not resolved the
matter through good faith negotiations the Parties shall resolve the matter
through arbitration under Section 17.
7
5. Fees,
Payments and Royalties.
5.1 In
partial consideration for this Agreement, Modigene has previously issued to
WU
Two Hundred Twenty-One Thousand Nine Hundred Seventy Nine (221,979) shares
of
common stock in Modigene, Inc.
5.2 Modigene
shall pay to WU a non-refundable, non-creditable license issue fee of $100,000,
of which twenty-five percent (25%) shall be due and payable within thirty (30)
days of the Effective Date. Fifty percent (50%) of the aforementioned license
issue fee shall be due and payable on the first anniversary of the Effective
Date, and the remaining twenty-five percent (25%) shall be due and payable
within the eighteen-month period following the Effective Date.
5.3
No later
than thirty (30) days after commencement of a Calendar Half Year, Modigene
shall
pay to WU a non-refundable, non-creditable license maintenance fee as
follows:
5.3.1 Payment
equal to $15,000 per Calendar Half Year beginning on the first anniversary
of
the Effective Date and continuing until the First Commercial Sale, but including
such payment for the Calendar Half Year in which the First Commercial Sale
occurs.
5.3.2 License
maintenance fee payments hereunder shall cease the Calendar Half Year
immediately after the First Commercial Sale in the United States.
5.4 Modigene
shall pay to WU a non-refundable minimum royalty for each Licensed Product
sold
by Modigene, its Affiliates or its Sublicensees. The first calendar period
for
which the minimum royalty will be paid will begin on the first day of the
Calendar Half Year following the Calendar Half Year in which the First
Commercial Sale for each Licensed Product occurs. Payments under this Section
5.3 will be due in the following amounts for the corresponding calendar
periods:
|
5.4.1 Period
|
Minimum Royalty |
|
First
Two (2) Calendar Half Years
|
$5,000
per Calendar Half Year
|
|
Third
and Fourth Calendar Half Years
|
$10,000
per Calendar Half Year
|
|
Fifth
and Each Subsequent Calendar
|
$20,000
per Calendar Half Year
|
|
Half
Year
|
|
8
5.4.2 Minimum
royalties will be paid on January 31 and July 31 of each respective Calendar
Half Year.
5.5
Modigene
shall pay to WU an earned royalty of 5% of
Net
Sales of any Licensed Product that contains one or more Additional Molecules
and
1.5 % of Net Sales for all
Licensed Products that have one or more of The Eleven Molecules.
5.5.1 Earned
royalties payable under Section 5.4 are fully creditable against minimum
royalties called for in Section 5.3 and subsections, above.
5.5.2 Earned
royalties will be accumulated and reported each Calendar Half Year. Modigene
will pay to WU earned royalties accumulated during a Calendar Half Year on
the
January 31 or July 31 immediately following the end of that Calendar Half Year.
5.5.3 To
calculate the value of Net Sales of Combination Products, the Net Sales of
such
Combination Products will be multiplied by the fraction A/(A + B) where A is
the
fair market value of the Licensed Product when sold separately, and B is the
fair market value of the Other Agents when sold separately.
5.6 Modigene
shall pay to WU 20% of Sublicensing Revenue of any Licensed Products that have
any Additional Molecules and 7.5 % of Sublicensing Revenue for
all
Licensed Products that have one or more of The Eleven Molecules.
5.6.1 Sublicensing
Revenue is fully creditable against minimum royalties called for in Section
5.3
and subsections above.
5.6.2 Sublicensing
Revenue will be accumulated and reported on a Calendar Half Year basis. Modigene
will pay to WU sublicense fees accumulated during a Calendar Half Year on the
January 31 or July 31 immediately following the end of that Calendar Half
Year.
5.7 Modigene
will pay to WU the following non-refundable, non-creditable milestone payments
for each of The Eleven Molecules and The Additional Molecules:
|
5.7.1
|
(A)
Filing of an IND Filing
|
$15,000
|
|
(B)
First dosing of first patient in a Phase IIb study
|
$30,000
|
|
|
(C)
First dosing of first patient in a Phase III study
|
$40,000
|
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5.7.2 Milestone
payments will be due on the January 31 or July 31 immediately following the
Calendar Half Year in which the milestone event set forth in Section 5.6.1
occurred.
5.8 No
multiple royalties will be required to be paid to WU because a Licensed Product
or its manufacture, use, sale or importation is covered by more than one Valid
Claim or patent or patent application within the Patent Rights.
5.9 All
earned royalties paid to a Third Party to obtain commercialization rights under
Third Party patents claiming all or part of the Patent Rights may be credited
against earned royalties due WU for Licensed Products of The Additional
Molecules, provided that the earned royalty paid to WU for The Additional
Molecules shall never be less that 3%.
5.10 For
clarity, there shall be no credit on the earned royalty of The Eleven Molecules
and the earned royalty shall never be less than the 1.5% for The Eleven
Molecules.
6. Place
and Method of Payment; Reports and Records; Audit;
Interest.
6.1 All
dollar ($) amounts referred to in this Agreement are expressed in United States
dollars. All payments to WU shall be made in United States dollars by check
or
electronic transfer payable to "Washington University." Any Sales revenues
for
Licensed Products in currency other than United States dollars shall be
converted to United States dollars using
the
average conversion rate of the daily closing prices in the applicable Calendar
Half Year as
published in the Eastern edition of The
Wall Street Journal.
| 6.2 |
Checks
shall reference WU Contract Number CA0089-90
and shall be sent to:
|
Accounting
Department
Office
of
Technology Management
Washington
University in St. Louis
000
Xxxxx
Xxxxxx Xxxxxx, XX 0000
Xx.
Xxxxx, XX 00000
All
payments shall include the WU Contract Number to ensure accurate crediting
to
Licensee’s account. Electronic transfers shall be made to a bank account
designated in writing by WU.
6.3
Modigene
shall deliver to WU, within forty-five (45) days of the end of each Calendar
Half Year in which earned royalties and/or Sublicensing Revenue are owed and
payable, a written report setting forth the calculation of the payments made
to
WU for that Calendar Half Year, including at least the following:
10
6.3.1 The
number of Licensed Products sold and amount of Sales by country.
6.3.2 Gross
receipts for Sales of Licensed Products including total amounts invoiced and
received.
6.3.3 Permissible
Deductions, as defined in Section 2.14, giving totals by each type.
6.3.4 Net
Sales
of Licensed Products by country.
6.3.5 Royalties,
fees and payments due to WU, giving totals for each category.
6.3.6 Earned
royalty amounts credited against minimum royalty payments.
6.4 Modigene
shall maintain, and shall require its Sublicensees to maintain, complete and
accurate books of account and records that would enable an independent auditor
to verify the amounts paid as royalties, fees and payments under this Agreement.
Modigene must also require its Sublicensees to file reports to Modigene to
enable Modigene to comply with all record keeping and reporting obligations
in
this Agreement. The books and records must be maintained for three years
following the Calendar Half Year after submission of the reports required by
this Article. Upon prior written notice by WU of at least sixty (60) days,
Modigene will give a
certified, independent public accountant selected by WU and acceptable to
Licensee (“CPA”) access
to
all books and records relating to Sales of Licensed Products by Modigene to
conduct, at WU’s expense, an audit or review of those books and records. This
access will be available no more then once annually, during regular business
hours, during the Term of the Agreement and for the three calendar years
following the year in which termination or expiration occurs. However, if the
audit or review reports that Modigene has underpaid royalties by 5% or more
for
any Calendar Half Year, Modigene shall reimburse WU for the reasonable costs
and
expenses of the accountants and auditors in connection with the review and
audit. WU
agrees
that all information subject to review under this Section 6.4 is
confidential, such CPA shall enter into a confidentiality agreement with
Modigene, and that it shall direct the CPA conducting the audit to retain all
such information in confidence. The CPA shall only report to WU regarding
royalty payments. Any report prepared as a result of or in connection with
the
audit pursuant to this Section 6.4 shall be regarded as Licensee’s Confidential
Information and WU hereby agrees not to use any information in such report
for
any purpose other than determining whether Licensee has complied with its
obligations under, and enforcing the terms of, this Agreement.
6.5 Any
amounts not paid by Modigene to WU when due shall accrue interest, from the
due
date until payment is made, at an annual rate equal to one percent (1%) above
the prime rate published in the Eastern edition of The Wall Street Journal
during the period of arrearage (or the maximum allowed by law, if less than
the
amount specified herein).
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7. Confidentiality
7.1
“Confidential Information” shall include all information disclosed by one Party
(in this section 7, the “Disclosing Party”) to the other party (in this section
7, the “Receiving Party”) at any time before or after the execution of this
Agreement which is in any way related to the Patent Rights, the Licensed
Products and specifically includes, without limitation, all unpublished Patent
Rights as well as (a) data, documents, tangible items, materials, prototypes,
formulas, patterns, programs, methods, techniques, processes, studies, analyses,
records, schedules, reports, specifications, plans, technical data,
compilations, devices, inventions, engineering and laboratory notebooks, bills
of materials, drawings, manuscripts and models, (b) information by any means,
including, but not limited to, oral, electronic, written, graphical,
demonstrative, and physical means as well as site visits, inspections or other
observations by Licensee, and (c) duplications and translations of any of the
foregoing.
7.2 The
Receiving Party will maintain in secrecy and not disclose to any Third Party
and
any employee or agent other than such employees or agents only on a need-to-know
basis of such Confidential Information to effectuate this Agreement, any of
the
Disclosing Party’s Confidential Information. The Receiving Party will ensure
that its employees (and other parties, when Modigene is the Receiving Party)
have access to the Disclosing Party's Confidential Information only on a
need-to-know basis and are obligated by written agreement to keep the Disclosing
Party's confidentiality obligations under this Agreement.
7.3 The
obligations of confidentiality specified in this Article will not extend to
Confidential Information that:
7.3.1 Becomes
part of the public domain through no fault of the Receiving Party;
7.3.2 Was
known
to the Receiving Party before disclosure to the Receiving Party by the
Disclosing Party as established by clear and convincing documentary evidence;
7.3.3 Comprises
identical subject matter to that which had been originally and independently
developed by the Receiving Party personnel without knowledge or use of any
of
the Disclosing Party’s Confidential Information; or
7.3.4 Was
disclosed to the Receiving Party by a Third Party having a right to make the
disclosure.
12
7.4 Notwithstanding
the other terms of this Article 7, the Receiving Party may, to the extent
necessary, use Confidential Information to secure governmental approval to
clinically test or market a Licensed Product, to secure patent protection for
an
invention within the Patent Rights, to comply with a court order or governmental
rule or regulation, or to show to a potential sublicensee or contractor subject
to an appropriate confidentiality agreement. The Receiving Party will, in any
such use, take all reasonably available steps to maintain confidentiality of
the
disclosed Confidential Information and to guard against any further
disclosure.
8. Representations
and Warranties.
8.1 WU
represents and warrants that:
8.1.1 It
is a
corporation organized, existing and in good standing under the laws of
Missouri.
8.1.2 It
has
the authority to enter into this Agreement and that the person signing on its
behalf has the authority to do so.
8.1.3 To
the
best of its knowledge, it is the sole owner (subject to any rights retained
by
the U.S. government by operation of law) of the Patent Rights licensed in this
Agreement and that it has the authority to grant the licenses set forth herein.
8.1.4 To
the
best of its knowledge, it has not granted the rights or an option to such rights
as defined in this Agreement to a Third Party.
8.1.5 To
the
best of its knowledge, as of the Effective Date of the Agreement, there are
no
actions, suits or claims pending against WU challenging WU's ownership or
control of the Patent Rights licensed in this Agreement.
8.1.6 All
inventors named in patent applications within the Patent Rights have entered
into agreements with WU assigning to WU their entire right, title and interest
in and to the patent application(s) describing and/or claiming their
invention(s).
8.1.7
To
the
best of its knowledge, no
claim
or legal proceeding with respect to infringement, misappropriation or violation
of any Patent Rights is or has been pending or threatened against it with
respect to Patent
Rights,
or
against any other person who is, or has asserted or could reasonably be expected
to assert that it is, entitled to be indemnified, defended, held harmless or
reimbursed by WU with respect to such claim or legal proceeding (including
any
claim or legal proceeding that has been settled, dismissed or otherwise
concluded), and WU received no requests or notices from any third party alleging
that WU is obligated to indemnify, defend, or hold them harmless with respect
to
any such claim or legal proceeding.
13
8.2 Modigene
represents and warrants that:
8.2.1 It
is a
corporation duly organized, existing, and in good standing under the laws of
the
state of Delaware.
8.2.2 The
execution, delivery and performance of this Agreement have been authorized
by
all necessary corporate action on the part of Modigene and that the person
signing the Agreement on behalf of Modigene has the authority to do
so.
8.2.3 The
making or performance of this Agreement would not violate any separate agreement
it has with any Affiliate or Third Party.
8.2.4 It
is not
a party to any agreement or arrangement that would prevent it from performing
its duties and fulfilling its obligations to WU under this
Agreement.
8.2.5 It
has
obtained or will obtain and maintain the insurance coverage required in Section
12.2.1 and will obtain and maintain all future coverage required in Article
12
of this Agreement.
8.2.6
There
is
no pending litigation and, to the best of its knowledge, no threatened claims
against it that could impair its ability or capacity to perform and fulfill
its
duties and obligations under this Agreement, including, but not limited to,
the
Development Plan.
8.3 Nothing
in this Agreement is or will be construed as:
8.3.1 A
warranty or representation by WU as to the validity, scope, or efficacy of
Patent Rights.
8.3.2 A
grant,
by implication, estoppel, or otherwise, of any licenses or rights under patents
or other intellectual property rights of WU or other persons, other than the
rights expressly granted above to Patent Rights.
8.3.3 An
obligation to furnish any technology or technological information other than
that identified in the attached Exhibits.
8.3.4 A
grant
of rights to either Party to use the name of the other in advertising,
publicity, or otherwise, except as expressly authorized herein, without the
written permission of the other Party.
8.4 EXCEPT
AS
EXPRESSLY SET FORTH IN SECTIONS 8.1.3 THROUGH 8.1.7 OF THIS AGREEMENT, WU
PROVIDES THE PATENT RIGHTS "AS IS," AND MAKES NO REPRESENTATIONS AND EXTENDS
NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS OF ANY PATENT RIGHTS OR
LICENSED PRODUCT FOR A PARTICULAR PURPOSE, OR THAT THE MAKING, USING OR SELLING
OF ANY LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK
OR
OTHER THIRD PARTY RIGHTS. WU MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT
TO
THE PERFORMANCE OF LICENSED PATENT RIGHTS OR ANY LICENSED PRODUCT, INCLUDING
THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. WU WILL NOT BE LIABLE
TO
MODIGENE,
OR ITS
AFFILLIATES, SUCCESSORS, ASSIGNS, CONTRACTORS, OR SUBLICENSEES, OR ANY THIRD
PARTY REGARDING ANY CLAIM ARISING FROM OR RELATING TO MODIGENE’S USE OF LICENSED
PATENT RIGHTS OR ANY LICENSED PRODUCT, OR FROM THE MANUFACTURE, USE, IMPORTATION
OR SALE OF LICENSED PRODUCTS, OR FOR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR
INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, OR
CONSEQUENTIAL DAMAGES OF ANY KIND. THE FOREGOING LIMITATIONS SHALL APPLY
REGARDLESS WHETHER WU OR ANYONE ACTING ON ITS BEHALF IS ALLEGED OR PROVEN TO
HAVE BEEN NEGLIGENT OR OTHERWISE AT FAULT IN ANY WAY.
14
9. Application,
Prosecution and Maintenance of Patent Rights.
9.1
WU
has
the sole right to control preparation, filing, prosecution, issue and
maintenance of Patent Rights patents and applications. WU will instruct outside
patent counsel within thirty (30) days from the Effective Date, to provide
Licensee a CD or DVD which contains copies of the public record of prosecution
history of the Patent Rights with the US and foreign patent offices. All costs
invoiced to WU by the law firms that are associated with supplying these
documents will be reimbursed in full to WU by Modigene. Prior to filing any
document with the patent office of Canada and Japan, WU shall provide Licensee
with a draft for review and comments at least 10 days prior to such filing.
However, should WU decide to abandon any Patent Rights patents and applications,
WU shall notify Licensee of such intent at least thirty (30) days prior to
any deadline at which such abandonment becomes irrevocable (the “Deadline Date”)
and Licensee may, at its own expense, prosecute and maintain said patent
application. Should Licensee assume such prosecution and maintenance, Licensee’s
obligations to pay royalties for Licensed Products and its License with respect
to said patent or application shall cease as of said Deadline Date. WU agrees
to
reasonably cooperate with Licensee at Licensee's request to whatever extent
is
reasonably necessary, to procure patent protection for Patent Rights, including
fully agreeing to execute any and all documents to provide Licensee the full
benefit of the licenses granted herein.
10. Infringement,
Enforcement, and Defense.
10.1 The
Parties shall give prompt written notice to each other of (a) any known or
suspected infringement of the Patent Rights in respect of Licensed Products
by a
Third Party, and (b) any claim that a Licensed Product infringes the
intellectual property rights of a Third Party.
15
10.2 Modigene
shall have the first right, but not the obligation, to attempt to xxxxx any
infringement, of the Patent Rights in respect of Licensed Products by a Third
Party in the Field and Territory. Modigene
shall have the right, but shall not be obligated to xxx, prosecute, take action
against, oppose, enter ex party or inter party actions, defend any
reexamination, interferences, oppositions of the Patent Rights; and any and
all
misappropriations, conveyances, uses, and/or transfers of Patent Rights to
Third
Parties and in furtherance of such right at its own expense through
outside counsel of its choice.
Before
commencing such action, Modigene shall consult with WU and shall give careful
consideration to the views of WU regarding the advisability of the proposed
action and its potential effects on the WU’s interests.
Modigene
may initiate and prosecute actions in WU’s name against Third Parties for such
infringement and/or unfair trade practices through outside counsel of its choice
who are reasonably acceptable to WU. Modigene shall consult with WU prior to
and
in conjunction with all significant issues, shall keep WU informed of all
proceedings, and shall provide copies to WU of all pleadings, legal analyses,
and other papers related to such actions. WU will provide reasonable assistance
to Modigene in prosecuting any such actions.
10.3 Notwithstanding
anything herein to the contrary and absent WU’s prior written consent which
shall not be unreasonable withheld, Modigene shall not settle or compromise
any
claim or action in a manner that imposes restrictions or obligations on WU,
requires any financial payment by WU, or grant rights or concessions to a Third
Party to Patent Rights or a Licensed Product.
10.4 Modigene
will be entitled to offset against earned royalties and Sublicensing Revenue
due
under Sections 5.4 and 5.5 hereof,
10.4.1 All
reasonable and necessary attorney's fees and expenses incurred in abating,
bringing, or defending against Third Party claims of infringement or unfair
trade practices against Patent Rights in respect of Licensed Products, or in
bringing or defending an action against a Third Party under this Article,
provided,
however, that in no event shall the royalty and fee payments due to WU be
reduced by more than fifty percent (50%) in any Calendar Half Year. In such
an
event the portion of such attorney’s fees and expenses not included shall be
credited to the year after and thereafter until such amount is zero;
10.4.2 In
the
event that, at any time prior to the date of expiration or invalidity of the
last to expire of any WU patent with the Patent Rights containing a Valid Claim
which covers the sale of a Licensed Product in said country, Modigene is
required, for the purpose of Developing or Commercializing said Licensed Product
in a particular country, to obtain from a Third Party a license relating to
the
subject matter of a WU patent within the Patent Rights, then Modigene shall
have
the right to off set fifty percent (50%) of said royalties and Sublicensing
Revenue payable by Modigene to such Third Party against the royalties and
Sublicensing Revenue that would otherwise be due to WU; provided,
however, that in no event shall the royalty and fee payments due to WU be
reduced by more than fifty percent (50%) in any Calendar Half Year.
16
10.5 If
Modigene fails or declines to take any action under Section 10.2 within a
reasonable time after learning of Third Party infringement or unfair trade
practices in respect of Licensed Products, WU shall have the right, but not
the
obligation, to take appropriate actions against any such Third Party. If
Modigene fails to defend a claim or action under Section 10 within one hundred
twenty (120) days of learning of the same, WU may assume the defense at its
sole
costs and expenses. WU shall keep Modigene informed of all proceedings, and
shall provide copies to Modigene of all pleadings, legal analyses, and other
papers related to such actions. Modigene will provide reasonable assistance
to
WU in prosecuting any such actions.
10.6 Any
award
paid by Third Parties as the result of such proceedings (whether by way of
settlement or otherwise) shall first be applied to reimbursement of the
unreimbursed legal fees and expenses incurred by either Party and then the
remainder shall be divided based on the Sublicensing terms in Section 5.
11. Indemnification
11.1
General.
Subject to the further provisions of this Article 11, Licensee agrees to
indemnify, defend and hold harmless WU, WU’s Affiliates, and, as applicable,
each of their respective present and former trustees, faculty, staff, employees,
students, directors, officers, agents, successors and assigns (each a “WU
Indemnitee”) from and against any and all judgments, losses, expenses, damages
and/or liabilities (including, without limitation, any and all attorneys’ and
expert witness fees and court costs), that a WU Indemnitee may incur from any
and all claims, suits, actions and/or proceedings (collectively, “Claims”)
arising out of, (a) any act, error or omission of Licensee, Affiliate or
Sublicensee, including without limitation, any act, error, or omission that
results in injury or death to person, damage to property, products liability,
and/or any injury to business (such as, but not limited to, business
interruption or damage to reputation) arising out of, the
making and using of or other exploitation of the Patent Rights or
Licensed Product, (b) any act, error or omissions in connection with developing,
testing, or obtaining or seeking to obtain regulatory approval for any Licensed
Product, (c) a breach of this Agreement by Licensee, Affiliate or Sublicensee
or
any allegation which, if true, would constitute a breach of this Agreement
by
Licensee, and/or
(c)
the
use
or
other
exploitation of the Patent Rights, in
the
design, development, production, manufacture, sale or offer for sale, use,
importation, lease, marketing, performance or promotion of any Licensed Product
by Licensee, Affiliate or Sublicensee including,
without limitation, claims for infringement or misappropriation of a third
party’s intellectual property rights or product liability,
except
that Modigene shall not indemnify, defend, and hold harmless WU Indemnitee
for
any judgments, losses, expenses, damages and/or liabilities due to gross
negligence or willful misconduct of such WU Indemnitee. Gross negligence means
conduct of sufficient culpability to support, under applicable state law, the
imposition of punitive damages. Licensee does not agree to indemnify, defend
and
hold harmless a WU Indemnitee from any and against any and all Claims for any
activities that are from future academic research, education and other
non-commercial uses of the Patent Rights provided for under Section 3.4
above.
17
11.2
Defense,
Cooperation and Settlement. With respect to any Claim where Licensee has
irrevocably acknowledged a duty to indemnify WU Indemnitees, Licensee shall
conduct the defense of such Claims through outside counsel of its choice who
are
reasonably acceptable to WU. However, each WU Indemnitee shall have the right
(but not the obligation) to participate in such defense at their own expense
through counsel of their own choosing. Licensee shall consult with WU prior
to
and in conjunction with all significant issues, shall keep WU informed of all
proceedings, and shall provide copies to WU of all pleadings, legal analyses,
and other papers related to such actions. WU will provide reasonable assistance
to Licensee in defending any such Claims. Licensee may not settle, compromise,
or otherwise enter into any form of settlement (or other similar agreement)
regarding any Claim that either (a) admits liability on the part of any WU
Indemnitee, (b) otherwise negatively affects the rights of any WU Indemnitee
or
imposes any liability, restrictions or obligation upon any WU Indemnitee, (c)
requires any financial payment by any WU Indemnitee, and/or (d) grants rights
or
concessions to a third party to the Patent Rights and any Licensed Products
unless in compliance with the terms of this Agreement as a Sublicensee, in
each
instance without the advance written consent of the applicable WU Indemnitee.
Licensee agrees to comply with all reasonable requests for information by WU
regarding the defense of any Claim and, if requested by WU, shall enter into
a
joint defense agreement with WU.
11.3 Failure
to Defend.
A
failure by Licensee to undertake or maintain the defense of a Claim, or timely
to undertake the defense of a Claim shall not release Licensee from its
obligations under this Agreement including, without limitation, its obligations
under this Article 11. However, in the event of any such failure or delay,
the
applicable WU Indemnitee shall have the right (but not the obligation) itself
to
undertake, or to have another for it undertake, the defense (including
settlement) of any such Claim, which shall be on behalf of, for the account
of,
and at the sole risk of Licensee. Moreover, with respect to any Claim for which
Licensee has not irrevocably acknowledged a duty to indemnify WU Indemnitees,
WU
shall be entitled to conduct and direct its own defense and that of other WU
Indemnities using attorneys of its own selection (subject to Licensee’s approval
which shall not be unreasonably withheld), but it shall consult with Licensee
on
litigation strategy. In any such event, Licensee shall take all actions which
reasonably are required and shall cause all actions to be taken which Licensee
reasonably can cause to be taken in order to effectuate an orderly transition
of
such defense and, if applicable, such negotiations in respect of the settlement
of any such Claim, to that WU Indemnitee and legal counsel selected by or for
that WU Indemnitee to represent that WU Indemnitee in the foregoing regards
in
respect of such Claim including, without limitation, providing that WU
Indemnitee and/or such counsel with a copy of all related documents including,
without limitation, all work product developed or otherwise generated in the
course of satisfaction by Licensee of its indemnification obligations in respect
of such Claim as to such WU Indemnitee. For the avoidance of doubt, the
assumption of the defense of any Claim by or for an WU Indemnitee shall not
release Licensee from its obligations under this Agreement including, without
limitation, its obligations under this Article 11, and, accordingly, such
defense (including settlement) of such claim shall be on behalf of, for the
account of, and at the sole risk of Licensee.
18
11.4 Miscellaneous.
For the
avoidance of doubt, Licensee’s obligations under Section 11.1 above shall apply
regardless whether any WU Indemnitee is named, either jointly or severally,
as a
party defendant in any lawsuit or whether any WU Indemnitee is alleged or found
to have been negligent or in any other way responsible for any loss, damage,
or
injury of any kind. Licensee’s obligation hereunder to defend WU Indemnitiees,
as distinct from Licensee’s obligation to indemnify, shall apply unless the
allegations of the Claim, on their face, confine the Claim to one not described
in Section 11.1 (a), (b), (c) or (d). Each WU Indemnitee which is not a party
to
this Agreement shall be deemed to be a third party beneficiary of this
Agreement. The obligations set forth in this Article 11 shall survive
termination of this Agreement, shall continue even after assignment of rights
and responsibilities, and shall not be limited by any other provision of this
Agreement.
12. Insurance.
12.1
General.
Throughout the term of this Agreement and for a period of ten (10) years
thereafter, Licensee shall obtain and maintain, in full force and effect and
at
Licensee’s sole cost and expense, one or more insurance policies providing: (a)
worker’s compensation insurance in respect of all of Licensee’s employees with
limits of liability and coverage not less than is from time-to-time required
by
all applicable laws, and (b) Insurance Services Office (“ISO”) commercial
general liability coverage as it exists as of the Effective Date written on
an
occurrence basis, or its equivalent in the event such ISO form is discontinued
or modified (including, without limitation any event, coverage and any necessary
endorsements for products /completed operations, blanket broad form contractual
liability as well as for clinical trials if any such trials are to be performed
by or on behalf of Licensee) which provides, for each annual policy period,
coverage and insurer's liability of no less than the minimum limits specified
in
Section 12.2 below for injury, death and property damage resulting from each
occurrence during the policy period.
12.2
Policy
Limits.
Subject
to the further provisions of this Section 12.2, the comprehensive commercial
general liability coverage shall have the following minimum limits:
19
12.2.1 From
the
Effective Date until the date prior to the IND$1,000,000 each occurrence;
$2,000,000 General Aggregate (other than Products/Completed Operations),
$2,000,000, Products/Completed Operations Aggregate.
12.2.2 From
the
date prior to the first clinical study to the date prior to First Commercial
Sale: $5,000,000 each occurrence, $10,000,000 General Aggregate (other than
Products/Completed Operations); $ 10,000,000 Products/Completed Operations
Aggregate. The General Aggregate and Product/Completed Operations Aggregate
may
be lowered to no less than $5,000,000 upon written notice to WU and written
findings by the Licensee’s insurer that such lower coverage is appropriate and
customary to such clinical studies.
12.2.3 From
the
date prior to the First Commercial Sale: $10,000,000 each occurrence;
$25,000,000 General Aggregate (other than Products/Completed Operations);
$25,000,000 Products/Completed Operations Aggregate.
The
minimum limits of insurance set forth above may be met by a combination of
primary insurance and commercial excess liability insurance policies. Modigene
and WU may periodically evaluate the adequacy of the minimum coverage of
insurance and deductible limits specified in this Article. WU reserves the
right
to require Licensee to adjust the insurance coverage by modifying the types
of
required coverages, the limits and/or financial rating and/or the method of
financial rating of Licensee’s insurers as such changes are required of WU by
its insurance carrier.
12.3
Policy
Specifics. Each policy of insurance which Licensee is required to obtain
hereunder shall (a) be with reputable and financially secure insurance carriers
having at least an A rating (A rating or above by A.M. Best) and an A.M. Best
Class Size of at least VIII, (b) list each of WU, its trustees, faculty, staff,
students, agents and their respective successors, heirs and assigns as
additional insured, (c) be endorsed to provide that the insurer waives all
subrogation rights which the insurer otherwise has or could have against any
additional insured, (d) be primary in respect of all additional insured, and
(e)
provide that the identified insurer will not cancel or fail to renew the
identified insurance without giving WU at least 30 days' prior written notice
thereof.
12.4 Evidence
of Insurance. Modigene shall provide WU with a copy of the Certificate of
Insurance from each such insurer which evidences compliance upon request by
WU.
.
12.5
Clarifications.
For the avoidance of doubt, the minimum insurance coverage and limits set forth
in this Agreement do not constitute a limitation on Licensee’s liability or
obligations to indemnify or defend WU and any other additional insured under
this Agreement.
13. Termination.
20
13.1 Modigene
may terminate this Agreement with or without cause on one hundred twenty (120)
days advance written notice to WU. The license rights granted in Article 3
shall
terminate at the end of the 120-day period.
13.2 WU
may
terminate this Agreement at the end of the ninety (90) days advance written
notice to Modigene upon Licensee’s material breach of the Agreement. The
termination becomes effective at the end of the ninety (90) day period unless
Modigene has fully cured the breach within that time. A material breach
includes, but is not limited to, one or more of the following:
13.2.1 Failure
to use reasonable commercial efforts to commercialize Licensed Products under
the Development Plan as required under Article 4.
13.2.2 Failure
to provide timely updates to or remain diligent under the Development Plan
as
required in Article 4.
13.2.3 Failure
to pay timely any fee, royalty, or other payment required under this
Agreement.
13.2.4 Failure
to keep accurate and complete books and records, failure to assure that
Sublicensees keep accurate books and records, and failure to allow an annual
audit and inspection, all as required by Article 6.
13.2.5
Breach or falsity of any of Modigene’s representations or warranties made in
this Agreement.
13.2.6
Failure to indemnify in accordance with Article 11 of this
Agreement.
13.2.7
Failure to include all necessary and required terms in all sublicenses, or
inclusion of any prohibited terms.
13.2.8
Failure properly to engage or consult WU in suits or claims to xxxxx or defend
as required in Article 10 of this Agreement.
13.2.9
If
Modigene enters bankruptcy or receivership, voluntarily or
involuntarily.
13.2.10
Failure to obtain, maintain, and/or timely report levels of insurance, as
required in Article 12
13.3 As
of the
date of termination of this Agreement by either Party for any reason pursuant
to
the terms herein, all license rights granted to Modigene under Article 3 shall
terminate. Modigene’s obligations
to pay fees, royalties, or other payments and patent expenses (Article 10)
accruing prior to termination shall survive termination.
21
14. Use
of Names. Neither
Party may use the name of the other for any commercial, advertisement, or
promotional purpose without the prior written consent of the other.
15. Assignment
or Pledge of Agreement. This
Agreement, in whole or in part, shall not be assigned by either Party to any
Third Party without the written consent of the non-assigning Party. However,
Modigene may assign the entire Agreement, without WU's consent, to a Third
Party
that acquires substantially all of Modigene’s business or assets through merger,
sale, acquisition, or other similar transaction, provided
that the
successor agrees in writing (with a copy of such assent to WU within ten (10)
days of the effective date of the transaction) to assume all obligations and
liabilities of Modigene to WU. The rights granted in this Agreement may not
be
pledged in any way by Modigene or any Sublicensee to secure any purchase or
lease.
16. Notice. Any
required or permissive notice under this Agreement will be sufficient if in
writing and delivered personally, by recognized national overnight courier,
or
by registered or certified mail, postage prepaid and return receipt requested,
to the address below and will be deemed to have been given as of the date shown
on the receipt if by certified or registered mail, or the day following dispatch
if by overnight courier.
|
If
to WU:
|
If
to Modigene:
|
|
|
Office
of Technology Management
|
||
|
Washington
University in St. Louis
|
0000
Xxxxxx Xxxxxxxx Xxxxx
|
|
|
000
Xxxxx Xxxxxx Xxxxxx, XX 0000
|
Suite
1300
|
|
|
St.
Louis, MO 63110
|
Xxxxxx,
XX 00000
|
|
|
With
copy to:
|
With
copy to:
|
|
|
Office
of General Counsel
|
Xxxxx
Xxxxx Zedek Xxxxxx LLP
|
|
|
Washington
University in St. Louis
|
Att:
Xxxx X. Xxxxx
|
|
|
One
Brookings Drive, Box 1058
|
0000
Xxxxxxxx
|
|
|
Xx.
Xxxxx, XX 00000
|
Xxx
Xxxx, XX 00000
|
17. Dispute
Resolution.
17.1
Parties
agree that any dispute arising out of or relating to this Agreement shall be
resolved solely by means of the procedures set forth in this Section
17.
17.2
In
the event of any dispute arising out of or relating to this Agreement, the
affected Party shall notify the other Party, and the Parties shall attempt
in good faith to resolve the matter within twenty (20) business days after
the date notice is received by the other Party (the "Notice Date"). Any
disputes not resolved by good faith discussions then shall be referred to
senior managers of each Party, who shall meet at a mutually acceptable
time and location within thirty (30) days after the Notice Date and attempt
to
negotiate a settlement. If the matter remains unresolved within sixty (60)
days after the Notice Date, or if the senior managers fail to meet
within thirty (30) days after the Notice Date, the Parties shall submit the
dispute to non-binding mediation before a mediator acceptable to both
Parties. If the matter remains unresolved within sixty (60)
days after submitting to non-binding mediation either Party may pursue
any other remedies legally available to resolve the dispute, including court
action. Without waiving the right to commence litigation in court,
the parties agree that they will in good faith consider binding
arbitration as a form of alternative dispute resolution at the request of
the other party.
22
17.3
Although the procedures specified in this Section 17 are the sole and exclusive
procedures for the resolution of disputes arising out of or relating to this
Agreement, either Party may seek a preliminary injunction or other provisional
equitable relief if, in its reasonable judgment, that action is necessary to
avoid irreparable harm to itself or to preserve its rights under this
Agreement.
18. General
Provisions.
18.1 This
Agreement shall be governed by and interpreted according to the laws of the
State of New York without regard for or application of its internal conflict
of
laws rules. The Parties expressly agree not to contest personal jurisdiction
in
either of those courts and shall not move to dismiss any such action on the
basis of lack of personal jurisdiction or inconvenience of forum.
18.2 No
waiver
of any breach of this Agreement shall constitute a waiver of any other breach
of
the same or any other provision of this Agreement, and no waiver shall be
effective unless made in writing by the Party against whom the waiver is sought
to be asserted.
18.3 The
Parties acknowledge that they have read this Agreement, including the Exhibits
hereto, in its entirety and agree that this instrument comprises the entire
agreement, contract, and understanding of the Parties relating to the subject
matter of the Agreement.
18.4 This
Agreement cannot be changed, modified or amended except by a written instrument
subscribed by authorized representatives of the respective Parties.
18.5 Neither
Party is an agent or contractor of the other as a result of any transaction
under or related to this Agreement. Neither Party may in any way pledge the
other Party's credit or incur any obligation on behalf of the other
Party.
23
18.6 Except
as
set forth in Article 11, neither Party shall be liable to the other Party for
any special, consequential, incidental, or indirect damages arising out of
or
relating to this Agreement, however caused, under any theory of
liability.
18.7 The
provisions of this Agreement are severable in that if any provision in the
Agreement is finally determined by a court of competent jurisdiction to be
invalid or unenforceable, the remaining provisions of the Agreement shall remain
in full force and effect. It is the desire of the Parties that this Agreement
should be enforced to the maximum extent permitted by law and, should any
provision be finally determined to be void, illegal, and/or unenforceable,
the
Parties shall negotiate in good faith for a substitute term or provision that
carries out the original intent of the Parties to the greatest extent reasonably
possible.
18.8 If
the
performance of any obligation under this Agreement is prevented or impaired
by
acts of war, riot, acts or defaults of common carriers, or governmental laws
or
regulations, a Party will be excused from performance so long as such cause
continues to prevent or impair that Party's performance. The Party claiming
such
force
majeure
excuse
must promptly notify the other Party of the existence of the cause and must
at
all times use diligent efforts to resume and complete performance. This Section
18.7 will not excuse Modigene’s obligation
to pay fees, payments and royalties under Article 5 of the
Agreement.
18.9 WU
has no
responsibility and assumes no liability for product design, development, pre-
or
post-market regulatory approval, servicing, distribution, or marketing of any
Licensed Product, or for any decisions made or strategies devised relating
to
any Licensed Product.
18.10
Modigene
agrees, and shall cause all Affiliates and Sublicensees to agree, that in the
event a WU faculty or staff member serves Modigene or any sublicensee in the
capacity of consultant, officer, employee, board member, and advisor, pursuant
to contract, such WU faculty or staff member shall serve in his or her
individual capacity, as an independent contractor, and not as an agent or
representative of WU, that WU exercises no authority or control over such
faculty or staff member while acting in such capacity, that WU receives no
benefit from such activity, and that WU assumes no liability or obligation
in
connection with any such work or service undertaken by such faculty or staff
member. Modigene further agrees, and shall cause all sublicensees to agree,
that
any breach, error, or omission by a WU faculty or staff member acting in the
capacity set forth above in this paragraph shall not be imputed or otherwise
attributed to WU, and shall not constitute a breach of this Agreement by
WU.
18.11 All
representations, warranties, covenants, and agreements made herein that, by
their express terms or by implication, are to be performed after the execution
or termination of this Agreement, or are prospective in nature, shall survive
such execution and/or termination, as the case may be. This shall include,
but
not be limited to, the provisions in Articles 5, 6, 7, 8, 11, 12 and
14.
24
18.12
Each Party shall, at the reasonable request of the other, execute and deliver
to
the other such instruments and/or documents and shall take such actions as
may
be required to more effectively carry out the terms of this
Agreement.
18.13 This
Agreement may be executed in counterparts, each of which shall be deemed an
original and all of which when taken together shall be deemed one
instrument.
18.14
Impact
on
Tax-Exempt Status. Licensee has been advised (a) that WU is exempt from
federal income tax under Section 501(c) (3) of the Internal Revenue Code, (b)
that maintenance of such exempt status is of critical importance to WU and
to
its members, and (c) that WU has entered into this Agreement with the
expectation that there will be no adverse impact on its tax exempt status.
As
such, and if it becomes necessary, the parties agree to discuss any amendments,
modifications, or reforms this Agreement as necessary (i) in order to ensure
that there is no adverse impact on WU's tax exempt status, and (ii) in a manner
that preserves the economic terms of the Agreement, as well as the intellectual
property rights of WU as such rights are set forth in this
Agreement.
Witness: The
Parties have caused this Agreement to be executed in duplicate by their duly
qualified representatives.
| WASHINGTON UNIVERSITY | |||
| By: /s/ Xxxxxx X. Xxxxxxx, Xx., M.D. | |||
|
|
|||
| Title: Vice Chancellor for Research | |||
| Date: 02-02-07 |
| MODIGENE, INC. | |||
| By: /s/ Xxxx Xxxxx | |||
|
|
|||
|
Title:
President
Date:
2/15/07
|
25
EXHIBIT
A
|
Cty.
|
Subject
|
Appln.
No.
Appln.
Date
|
Patent
No.
Patent
Date
|
|||
|
US
|
C-Terminal
Extensions
|
08/483,023
06/07/1995
|
5,712,122
01/27/1998
|
|||
|
AU
|
C-Terminal
Extensions
|
6747494
02/20/1990
|
670510
11/05/1996
|
|||
|
CA
|
C-Terminal
Extensions
|
2053864
02/20/1990
|
2053864
11/20/2001
|
|||
|
EP
|
C-Terminal
Extensions
|
909051153
02/20/1990
|
0461200
01/24/1997
|
|||
|
Validated
in: AT, BE, DK, FR, DE, GB, IT, LU, NL, ES, SE, CH
|
||||||
|
JP
|
C-Terminal
Extensions
|
02505031
02/20/1990
|
3045539
03/17/2000
|
|||
|
US
|
N-Terminal
Extensions
|
08/485,692
06/07/1995
|
5,759,818
06/02/1998
|
|||
|
AU
|
N-Terminal
Extensions
|
6633194
04/13/1994
|
687053
06/04/1998
|
|||
|
CA
|
N-Terminal
Extensions
|
2160800
04/13/1994
|
Pending
|
|||
|
EP
|
N-Terminal
Extensions
|
949141527
04/13/1994
|
0695307
12/15/1999
|
|||
|
Validated
in: AT, BE, IT, NL, ES, SE, CH
|
||||||
|
JP
|
N-Terminal
Extensions
|
06523422
04/13/1994
|
Pending
|
|||
|
US
|
MULTIPLE
CTP EXTENSIONS
|
07/771,262
10/04/1991
|
6,225,449
05/01/2001
|
|||
|
AU
|
MULTIPLE
CTP EXTENSIONS
|
2864892
10/02/1992
|
667489
07/16/1996
|
|||
|
CA
|
MULTIPLE
CTP EXTENSIONS
|
2120358
10/02/1992
|
Pending
|
|||
|
EP
|
MULTIPLE
CTP EXTENSIONS
|
929217594
10/02/1992
|
0607297
9/03/2003
|
26
