CONFIDENTIAL TREATMENT REQUESTED Information marked by [***] has been omitted pursuant to a request for confidential treatment. The omitted portion has been separately filed with the Securities and Exchange Commission. LICENSE AGREEMENT
Exhibit
10.6
CONFIDENTIAL
TREATMENT REQUESTED
Information
marked by [***] has been omitted pursuant to a request for
confidential
treatment. The omitted portion has been separately filed with
the
Securities and Exchange Commission.
This
Agreement is entered into on January 3, 2008, between THE OHIO STATE UNIVERSITY
RESEARCH FOUNDATION, located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇ and ARNO
THERAPEUTICS, INC., a Delaware corporation located at ▇▇ ▇▇▇ ▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇
▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇.
BACKGROUND
LICENSOR
owns certain PATENT RIGHTS (as defined in Section 1.19) relating to LICENSOR
Case No. 04021, "A Novel Class of PDK-1/Akt Signaling Inhibitors", and has
the
right to grant licenses under PATENT RIGHTS, (subject to only to a royalty-free
nonexclusive license previously granted to the United States Government) (the
“INVENTION”), which was invented at LICENSOR by ▇▇. ▇▇▇▇▇-▇▇▇▇ ▇▇▇▇
▇▇.▇▇.;
LICENSOR
desires to have the PATENT RIGHTS developed and commercialized to benefit the
public and is willing to grant a license for this purpose;
LICENSEE
has represented to LICENSOR, to induce LICENSOR to enter into this Agreement,
that LICENSEE is experienced in developing, producing, manufacturing, marketing,
and selling products similar to the LICENSED PRODUCT(s) (as later defined)
and/or using the LICENSED PROCESS(es) (as later defined) and that it shall
commit itself to a thorough, vigorous, and diligent program of exploiting the
PATENT RIGHTS so that the public shall benefit; and
LICENSEE
desires to obtain a license under the PATENT RIGHTS upon the terms and
conditions set forth below.
The
parties therefore agree as follows:
ARTICLE
1 - DEFINITIONS
For
purposes of this Agreement, the following words and phrases have the following
meanings:
1.1 “AFFILIATE”
shall mean any entity or person that directly or indirectly controls, is
controlled by or is under common control with LICENSEE or a SUBLICENSEE as
applicable. For purposes of this definition, “control” means possession of the
power to direct the management of such entity or person, whether through
ownership of more than fifty percent (50%) of voting securities, by contract
or
otherwise.
1.2 “CHANGE
OF CONTROL” shall mean a merger, consolidation, acquisition or the transfer of
all, or substantially all, of the business interests of LICENSEE to which this
Agreement relates to which LICENSEE is a party where the shareholders of
LICENSEE immediately prior to effective date of such transaction beneficially
own, immediately following the effective date of such transaction, securities
representing less than fifty percent (50%) of the combined voting power of
the
surviving corporation’s then outstanding voting securities.
1.3 “COMMERCIALLY
REASONABLE EFFORTS” shall mean documented efforts that are consistent with those
utilized by companies of similar size and type that are developing products
and
services similar to LICENSED PRODUCTS.
1.4 “CONFIDENTIAL
INFORMATION” means confidential or proprietary information relating to the
PATENT RIGHTS, LICENSED PRODUCTS or LICENSED PROCESSES. CONFIDENTIAL INFORMATION
may be in written, graphic, oral or physical form and may include scientific
knowledge, know-how, processes, inventions, techniques, formulae, products,
business operations, customer requirements, designs, sketches, photographs,
drawings, specifications, reports, studies, findings, data, plans or other
records, biological materials, and/or software. CONFIDENTIAL INFORMATION shall
not include:
|
(a)
|
information
that is, or later becomes, generally available to the public through
no
fault of the recipient;
|
|
(b)
|
information
that is provided to the recipient by an independent third party having
no
obligation to keep the information
secret;
|
|
(c)
|
information
that the recipient can establish was previously known to it or was
independently developed by it without reference to the CONFIDENTIAL
INFORMATION;
|
|
(d)
|
information
that is required to be disclosed to comply with applicable law or
court
order, including Ohio Revised Code Section 149.43, provided that
the
recipient gives prior written notice of the required disclosure to
the
discloser.
|
1.5 “EFFECTIVE
DATE” shall mean the date on which this Agreement is fully executed by both
parties.
1.6 “FDA”
shall mean the United States Food and Drug Administration or successor
entity.
1.7 "FIELD
OF
USE" means all therapeutic uses in humans and animals, including (a) use as
a
cancer therapeutic (“First Field”) and (b) use as an anti-infective agent
(“Second Field”).
1.8 “FIRST
SALE” shall mean the first commercial sale to a third party of any LICENSED
PRODUCT in the LICENSED TERRITORY (as defined below).
1.9 “IMPROVEMENTS”
shall mean any and all intellectual property relating to a LICENSED PRODUCT
or
PATENT RIGHTS made by the INVENTOR, including, without limitation improved
methods of manufacture and production techniques, new or additional analogs,
to
the extent that such analogs are a part of the same class of compounds contained
within PATENT RIGHTS, therapeutic indications and developments intended to
enhance the safety and efficacy of the LICENSED PRODUCTS.
1.10 “IND”
shall mean an investigational new drug application filed with the FDA prior
to
the commencement of human clinical trials in the United States pursuant to
21
C.F.R. §312(a).
1.11 “INVENTORS”
shall mean ▇▇. ▇▇▇▇▇-▇▇▇▇ ▇▇▇▇ and such other inventors as are listed as such
on
any patent application or patent contained within PATENT RIGHTS.
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1.12 “LICENSED
INFORMATION” shall mean all technical information and data, whether or not
patented invented or developed by LICENSOR, to the extent that (a) such
technical information and data are useful for the use or practice of the
PATENTS
RIGHTS
or
LICENSED
TECHNOLOGY
as
permitted herein; and (b) LICENSOR possesses the right to license the use of
such information to LICENSEE
for
commercial purposes.
1.13 “LICENSED
PROCESS” means any process that is covered in whole or in part by (a) a
VALID
CLAIM (as defined in Section 1.26
below)
contained
in the PATENT RIGHTS in the country in which such LICENSED PROCESS is used
or
(b) a VALID CLAIM contained in the PATENT RIGHTS in the country to which a
product is imported where the LICENSED PROCESS is used to make the
product.
1.14 “LICENSED
PRODUCT” means any product or product part which (a) is covered in whole or in
part by a VALID
CLAIM contained
in the PATENT RIGHTS in the country in which any such product or product part
is
made, used or sold; or (b) is manufactured by using a LICENSED PROCESS in the
country in which any LICENSED PROCESS is used or in which such product or
product part is used or sold.
1.15 "LICENSEE"
means ARNO
THERAPEUTICS, INC.
and any
AFFILIATE of ARNO
THERAPEUTICS, INC.
1.16 “LICENSOR”
shall mean THE OHIO STATE UNIVERSITY RESEARCH FOUNDATION.
1.17 “NDA”
shall mean an application for FDA approval to market a new drug filed with
the
FDA pursuant to 21 C.F.R. §314.
1.18 “NET
SALES” shall mean the total gross amounts invoiced for sales of a LICENSED
PRODUCT by
or on
behalf of LICENSEE, its AFFILIATES and SUBLICENSEES
and from
leasing, renting, or otherwise making a LICENSED
PRODUCT or
LICENSED PROCESS available to others for profit without sale or other
dispositions, whether invoiced or not, less the following deductions, provided
they actually pertain to the disposition of LICENSED
PRODUCTS or
LICENSED PROCESSES and
are
separately invoiced:
| (a) |
discounts,
returns and allowances actually granted to
customers;
|
|
(b)
|
commissions
actually paid to third-party distributors and other third-party sales
agencies;
|
|
(c)
|
sales,
tariff duties and/or use taxes directly imposed and with reference
to
particular sales;
|
| (d) |
outbound
transportation prepaid or allowed and transportation insurance;
|
| (e) |
amounts
allowed or credited on returns;
|
|
(f)
|
bad
debt deductions actually written off during the accounting period;
and
|
| (g) |
packaging
and freight charges.
|
No
deductions shall be made for cost of collections or for commissions paid to
independent sales agencies or to individuals regularly employed by LICENSEE
and
on its payroll. LICENSED PRODUCTS are "sold" when billed out or
invoiced.
1.19 "PATENT
RIGHTS" means all U.S. and foreign patents and patent applications owned or
controlled by LICENSOR which relate to the composition of matter, method of
use,
manufacture, dosing, or administration of the INVENTION or any IMPROVEMENTS,
which shall include the following LICENSOR intellectual property:
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|
(a)
|
the
United States and foreign patents and/or patent applications listed
in
Appendix A;
|
|
(b)
|
United
States and foreign patents issued from the applications listed in
Appendix
A and from divisionals, and continuations of these
applications;
|
|
(c)
|
claims
of U.S. and foreign continuation-in-part applications, and of the
resulting patents, which are directed to subject matter specifically
described in the U.S. and foreign applications listed in Appendix
A;
|
|
(d)
|
claims
of all foreign patent applications, and of the resulting patents,
which
are directed to subject matter specifically described in the United
States
patents and/or patent applications described in (a), (b) or (c) above;
and
|
|
(e)
|
any
reissues or reexaminations of United States patents described in
(a), (b)
or (c) above.
|
1.20 “PHASE
I
CLINICAL TRIAL” shall mean the initial introduction of an investigational new
drug into humans, the principal purpose of which is to determine the metabolism
and pharmacologic actions of the drug in humans, the side effects associated
with increasing doses, and, if possible, to gain early evidence on
effectiveness, in compliance with 21 C.F.R. §312(a).
1.21 “PHASE
II
CLINICAL TRIAL” shall mean controlled human clinical studies conducted to
evaluate the effectiveness of a drug for a particular indication or indications
in patients with the disease or condition under study and to determine the
common short-term side effects and risks associated with the drug in compliance
with 21 C.F.R. §312(b).
1.22 “PHASE
III CLINICAL TRIAL” shall mean expanded controlled and uncontrolled human
clinical trials pursuant to a randomized study with endpoints agreed upon by
regulatory bodies for regulatory approval performed after PHASE II CLINICAL
TRIALS evidence suggesting effectiveness of a drug has been obtained, and is
intended to gather the additional information about effectiveness and safety
that is needed to evaluate the overall benefit-risk relationship of a drug
and
to provide an adequate basis for physician labeling, as in compliance with
21
C.F.R. §312.
1.23 “SUBLICENSEE”
shall mean any third party sublicensed by LICENSEE to make, have made, use,
sell, have sold, import or export any LICENSED PRODUCT.
1.24 “SUBLICENSE
FEES” shall include:
|
(a)
|
all
consideration, in whatever form, received from a SUBLICENSEE in connection
with a sublicense of the PATENT RIGHTS and LICENSED INFORMATION,
including, but not be limited to:
|
|
(i)
|
up
front fees received by LICENSEE for the granting of a sublicense
to a
SUBLICENSEE;
|
|
(ii)
|
MILESTONE
PAYMENTS
(as defined in Section 3.2 below) received by the LICENSEE from a
SUBLICENSEE; provided, however, that the LICENSOR shall not be entitled
to
any MILESTONE PAYMENTS made to the LICENSEE to the extent that the
LICENSOR would be otherwise entitled to a MILESTONE
PAYMENT
as
set forth in Section 3.2; and
|
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|
(iii)
|
Sublicense
maintenance fees.
|
(b) SUBLICENSE
FEES shall not include the following:
|
(i)
|
payments
received by LICENSEE from a SUBLICENSEE solely for a bona fide research
and development program which will be particularized in such SUBLICENSE
AGREEMENT with reasonable detail;
and
|
|
(ii)
|
the
purchase by a SUBLICENSEE of debt or equity securities of the
LICENSEE.
|
1.25 “TERRITORY”
means worldwide.
1.26 “VALID
CLAIM” shall
mean (a) an issued claim of any unexpired patent included among the PATENT
RIGHTS, which has not been held unenforceable, unpatentable or invalid by a
decision of a court or governmental body of competent jurisdiction, 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 abandoned or (b) a claim of a pending
patent application included within the PATENT RIGHTS, which claim was filed
in
good faith and has not been abandoned or finally disallowed without the
possibility of appeal or re-filing of such application.
ARTICLE
2 - GRANT
2.1 Subject
to all the terms and conditions of this Agreement, LICENSOR hereby grants to
LICENSEE and LICENSEE accepts, subject to the terms and conditions of this
Agreement, an exclusive, worldwide license, together with the right to grant
sublicenses, to practice under the PATENT RIGHTS and IMPROVEMENTS and to use
the
LICENSED INFORMATION, to make, have made, use, sell, have sold, offer to sell,
import or export LICENSED PRODUCTS and to practice LICENSED
PROCESSES.
2.2 Unless
terminated earlier as provided in Article 13, the term of the LICENSE (the
“TERM”) shall commence on the EFFECTIVE DATE and shall automatically expire on
the later of:
(a) the
date
on which the last VALID CLAIM described in the PATENT RIGHTS expires, lapses
or
is declared to be invalid by a non-appealable decision of a court of competent
jurisdiction; and
(b) twenty
(20) years after the EFFECTIVE DATE.
2.3 LICENSEE
agrees that LICENSED PRODUCTS leased or sold in the United States shall be
manufactured substantially in the United States.
2.4 LICENSOR
reserves the right to practice under the PATENT RIGHTS solely for non-commercial
research and educational purposes.
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2.5 To
the
extent that any invention included within the PATENT RIGHTS has been funded
in
whole or in part by the United States government, the United States government
retains certain rights in such invention including but not limited to the rights
set forth in 35 U.S.C. §200-212 and all regulations promulgated thereunder, as
amended, and any successor statutes and regulations (collectively the “Federal
Patent Policy”), notwithstanding anything in this Agreement to the contrary. As
a condition of the LICENSE granted hereby, LICENSEE acknowledges and shall
comply with all aspects of the Federal Patent Policy applicable to the PATENT
RIGHTS, including the obligation that LICENSED PRODUCTS used or sold in the
United States be manufactured substantially in the United States.
2.6 The
LICENSE granted in Article 2 shall automatically convert to a paid-up,
non-exclusive license, on a country-by-country basis, upon the expiration of
the
TERM.
ARTICLE
3 – LICENSE FEES MILESTONE PAYMENTS and ROYALTIES
3.1 LICENSEE
shall pay LICENSOR a one-time license issue fee of two hundred fifty
thousand dollars ($250,000). Subject only to a material, noncurable breach
of the representations and warranties of the LICEONSOR contained in Section
15.2, such license issue fee shall be nonrefundable and deemed earned and due
immediately upon the EFFECTIVE DATE.
3.2 LICENSEE
shall make the following one-time payments (the “MILESTONE PAYMENTS”) to
LICENSOR upon the successful accomplishment of the milestones described
below:
(a)
[***]
dollars ($[***]) upon the dosing of the first subject in the first PHASE I
CLINICAL TRIAL of a LICENSED PRODUCT in the United States conducted by the
LICENSEE pursuant to a corporate sponsored IND;
(b)
[***]
dollars ($[***]) upon the dosing of the first patient in the first PHASE II
CLINICAL TRIAL of a LICENSED PRODUCT conducted by the LICENSEE in the United
States;
(c)
[***]
dollars ($[***]) upon the dosing of the first patient in the first PHASE III
CLINICAL TRIAL of a LICENSED PRODUCT conducted by the LICENSEE in the United
States;
(d)
[***]
dollars ($[***]) upon the FIRST SALE of a LICENSED
PRODUCT
by the
LICENSEE, its AFFILIATES or SUBLICENSEE in the United States;
(e)
[***]
dollars ($[***]) upon FIRST SALE of a LICENSED
PRODUCT
by the
LICENSEE, its AFFILIATES or SUBLICENSEE in the first country in the European
Union;
(f)
[***]
dollars ($[***]) upon the FIRST SALE of a LICENSED
PRODUCT
by the
LICENSEE, its AFFILIATES or SUBLICENSEE in Japan; and
(g) One
million dollars ($1,000,000) upon the FIRST SALE of a LICENSED
PRODUCT
for the
Second Field by the LICENSEE, its AFFILIATES or SUBLICENSEE.
3.3 Except
for MILESTONE PAYMENTS described in Section 3.2(d)-(g), MILESTONE PAYMENTS
shall
be non-refundable and non-creditable against EARNED ROYALTIES (as defined in
Section 3.4 below). Notwithstanding the foregoing, MILESTONE PAYMENTS described
in Section 3.2(d)-(f) shall be fully creditable against EARNED
ROYALTIES.
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3.4 Subject
to the terms of this Section 3, during the TERM of this Agreement, as partial
consideration for the LICENSE, LICENSEE shall pay to LICENSOR an earned royalty
on worldwide cumulative NET SALES of LICENSED PRODUCTS and LICENSED PROCESSES
by
LICENSEE, its AFFILIATES or SUBLICENSEES (“EARNED ROYALTIES”) equal to [***]
percent ([***]%) of NET SALES by LICENSEE its AFFILIATES or SUBLICENSEES until
the term of the PATENT RIGHTS expires or until this Agreement is
terminated.
3.5 Following
the FIRST SALE, LICENSEE shall pay LICENSOR the following minimum annual
royalties:
(a) [***]
dollars ($[***]) per year until the third anniversary of the FIRST SALE of
a
LICENSED
PRODUCT;
and
thereafter
(b)
[***]
dollars ($[***]) per year.
Such
minimum annual royalty shall be deemed earned and accrued as of January 1 of
each calendar year after the effective date of this Agreement and shall be
due
no later than January 31 of each year. The minimum annual royalty payment shall
be credited against running royalties for the corresponding calendar year,
and
the quarterly reports under Section 6.3 shall reflect such credit. The minimum
annual royalty payments shall not be creditable against milestone payments
(if
any) or against royalty payments due for any other calendar year.
3.6 LICENSOR
shall be responsible for the payment of all taxes, duties, levies, and other
charges, including, but not limited to, sales, use, gross receipts, excise,
VAT,
and any other taxes, any withholdings or deductions, import and custom taxes,
any duties, or any other charges imposed by any taxing authority with respect
to
the royalties payable to LICENSOR under this agreement. Should LICENSEE be
required under any law or regulation of any government entity or authority,
domestic or foreign, to withhold or deduct any portion of the payments on
royalties due to LICENSOR, then the sum payable to LICENSOR shall be increased
by the amount necessary to yield to LICENSOR an amount equal to the sum it
would
have received had no withholdings or deductions been made. LICENSOR shall
cooperate with LICENSEE in the event LICENSEE elects to assert, at its own
expense, LICENSOR’s exemption from any such tax or deduction.
3.7 In
the
event that LICENSEE’S outside patent counsel together with LICENSOR’S patent
counsel agree (which discussion and agreement shall be in good faith) that
patent licenses from third parties are reasonably required by LICENSEE, its
AFFILIATES or its SUBLICENSEE to make, use, offer for sale, sell or import
any
LICENSED PRODUCT in any given country, LICENSOR and LICENSEE shall negotiate
in
good faith with the intention of reaching a fair and equitable formula on how
any amount paid by LICENSEE to such third parties shall impact the royalties
due
hereunder.
3.8 No
multiple royalties shall be payable because the use, lease or sale of any
LICENSED PRODUCT is, or shall be, covered by more than one VALID CLAIM contained
in the PATENT RIGHTS.
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3.9 In
the
event that a LICENSED PRODUCT is sold in the form of a combination package
together with companion products that are not themselves a LICESED PRODUCT,
the
NET SALES for such combination package upon which the sales royalties due to
LICENSOR is based shall be calculated by multiplying the total sales price
of
such combination package by the fraction A/(A+B), where A is the invoice price
of the LICENSED PRODUCT if sold separately, and B is the total invoice price
of
each of the other companion products included in the combination package if
sold
separately. In no event shall such deduction in the overall sales royalty rate
due to LICENSOR be reduced by more than [***] percent ([***]%).
3.10 Royalty
payments shall be paid in United States dollars in Columbus, Ohio, or at such
other place as LICENSOR may reasonably designate consistent with the laws and
regulations controlling in any foreign country. If any currency conversion
is
required in connection with the payment of royalties, such conversion shall
be
made by using the exchange rate as published as of the last business day of
the
applicable calendar quarter in the eastern edition of The Wall Street
Journal.
3.11 Royalty
payments shall be made on a quarterly basis with submission of the reports
required by Article 6, except any minimum annual royalty payment, which shall
be
due as provided in Section 3.5. Such payments and reports shall be due within
thirty (30) days of March 31, June 30, September 30, and December 31 of each
calendar year. Late payments, including payments due for patent cost
reimbursement, shall be subject to a charge of one and [***] percent ([***]%)
per month or $[***], whichever is greater. The payment of such late charge
shall
not foreclose LICENSOR from exercising any other rights it may have resulting
from any late payment.
ARTICLE
4 –
SUBLICENSES
4.1 LICENSEE
has the right to enter into sublicensing agreements with third-parties. LICENSEE
agrees that any sublicense granted by it shall provide that the obligations
to
LICENSOR of Articles 2, 6, 8, 9, 10, 13 and 16 of this Agreement shall be
binding upon the SUBLICENSEE as if it were a party to this Agreement. LICENSEE
further agrees to attach copies of these Articles to sublicense
agreements.
4.2 LICENSEE
shall forward to LICENSOR copies of all sublicense agreements promptly upon
execution by the parties.
4.3 In
addition to royalties provided under Section 3.3, for any sublicenses granted
by
LICENSEE hereunder, LICENSEE will pay to LICENSOR a percentage of any SUBLICENSE
FEES as follows:
|
YEARS FROM EFFECTIVE DATE
|
PERCENT OF SUBLICENSE FEES
|
|
|
Less
than [***]
|
[***]%
|
|
|
Year
[***] to Year [***]
|
[***]%
|
|
|
Thereafter
|
[***]%
|
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4.4 If
and to
the extent LICENSEE enters into a sublicense agreement that could result in
the
payment of a SUBLICENSEE FEE other than cash, LICENSEE shall notify LICENSOR
of
any such provision in the sublicense agreement at the time of its delivery
under
Section 4.2 above, and with respect thereto, if LICENSOR is prohibited by
applicable law from accepting the form of consideration LICENSEE has agreed
to
accept under such sublicense agreement, then LICENSEE shall be obligated to
satisfy its obligation to LICENSOR under Section 4.3 in such form of
consideration as LICENSOR is permitted by applicable law to accept, provided
however that in any such event the fair market value of any such substituted
consideration shall be at least equal to the fair market value of the form
of
consideration LICENSOR is unable to accept.
4.5 Provided
that a SUBLICENSEE agrees to assume all of the obligations of the LICENSEE
under
this Agreement, such SUBLICENSE shall survive the termination of this Agreement
in accordance with Section 13.
ARTICLE
5 - DUE DILIGENCE
5.1 LICENSEE
shall use COMMERCIALLY REASONABLE EFFORTS to bring one or more LICENSED PRODUCTS
or LICENSED PROCESSES to market through a thorough, vigorous and diligent
program for exploiting the PATENT RIGHTS and following FIRST SALE of a LICENSED
PRODUCT, to continue active, diligent marketing efforts for one or more LICENSED
PRODUCTS or LICENSED PROCESSES throughout the life of this
Agreement.
5.2 As
part
of these efforts, LICENSEE agrees on its own behalf and on behalf of its
AFFILIATES and SUBLICENSEES to achieve the following commercialization and
research and development milestones for the LICENSED PRODUCTS and LICENSED
PROCESSES:
(a) File
an
IND following completion of necessary non-clinical studies (i.e., acute and
chronic toxicity, etc.);
(b) Upon
IND
filing, LICENSEE,
its’
SUBLICENSEES, or their AFFILIATES,
shall
demonstrate ongoing engagement of clinical development for LICENSED
PRODUCTS,
which
shall be evidenced by conducting at least one of the following activities in
any
given year starting from the date of IND filing:
(i) having
expended at least [***] dollars ($[***]) for development of LICENSED
PRODUCTS;
(ii) having
manufactured LICENSED
PRODUCTS
suitable
for clinical trials under an approved IND;
(iii) having
actively engaged in study preparation, implementation, or reporting of a
PHASE
I,
II, OR III CLINICAL TRIAL
with
respect to a LICENSED
PRODUCT
or the
construction of regulatory documents for filing;
(iv) having
responded to regulatory requests/issues relating to a PHASE
I,
II, OR III CLINICAL TRIAL
of a
LICENSED
PRODUCT;
(v) having
prepared documents for NDA filing with respect to a LICENSED
PRODUCTS;
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(vi) having
filed an NDA for a LICENSED
PRODUCT;
(vii) following
NDA filing, having actively pursued NDA approval for a LICENSED
PRODUCT;
or
(viii) following
NDA approval of a LICENSED
PRODUCT,
having
launched or sold a LICENSED
PRODUCT
in the
United States or another major market country.
5.3 Failure
to perform the development activities described in Section 5.2 above shall
be
considered a breach of the LICENSE
unless
such failure is through no fault of the LICENSEE,
including without limitation, a change in regulatory guidelines, opinions or
standards; the introduction of a new standard of care during the development
of
LICENSED
PRODUCTS
which
affects the development strategy for LICENSED
PRODUCTS;
or
unexpected findings (safety or efficacy) in clinical studies, that delays
clinical development. In such an instance, the parties shall amend the timelines
accordingly. The LICENSOR shall provide LICENSEE with written notice of any
alleged breach of the LICENSE pursuant to this Article 5.3 in accordance with
Article 13.2.
5.4 LICENSEE
will
initially devote its efforts to the clinical development of LICENSED
PRODUCTS
in the
treatment of cancer, but shall agree to conduct a research and development
program relating to the use of LICENSED
PRODUCTS
in the
Second Field as soon as commercially practicable and shall thereafter continue
to diligently pursue research, development and commercialization in this
additional indication until FIRST SALE is achieved.
ARTICLE
6 - REPORTS AND RECORDS
6.1 LICENSEE
shall keep full, true and accurate books of account containing all particulars
necessary to show the amounts payable to LICENSOR. The books of account shall
be
kept at LICENSEE's principal place of business or the principal place of
business of the appropriate division of LICENSEE to which this Agreement
relates. The books and supporting data shall be open at all reasonable times
for
five (5) years following the end of the calendar year to which they pertain,
for
inspection by LICENSOR or its agents to verify LICENSEE's royalty statement
or
compliance in other respects with this Agreement. Should such inspection lead
to
the discovery of discrepancy in reporting which is greater than [***] percent
([***]%) to LICENSOR's detriment, LICENSEE agrees to pay the full cost of such
inspection.
6.2 LICENSEE
shall provide to LICENSOR a written annual report on or before September
1st
of each
calendar year. The annual report shall include: reports of progress on research
and development, regulatory approvals, manufacturing, sublicensing, marketing
and sales during the preceding twelve (12) months, and plans for the coming
year.
6.3 After
the
FIRST SALE of a LICENSED PRODUCT or LICENSED PROCESS, LICENSEE shall provide
quarterly reports to LICENSOR. The quarterly reports shall be delivered within
thirty (30) days after March 31, June 30, September 30, and December 31 of
each
year. The quarterly reports shall give particulars of the business conducted
by
LICENSEE and its SUBLICENSEES during the preceding quarter that are pertinent
to
a royalty accounting, including:
|
(a)
|
number
of LICENSED PRODUCTS manufactured and sold by LICENSEE and all
SUBLICENSEES and AFFILIATES;
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(b)
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total
▇▇▇▇▇▇▇▇ for LICENSED PRODUCTS sold by LICENSEE and all SUBLICENSEES
and
AFFILIATES;
|
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(c)
|
accounting
for all LICENSED PROCESSES used or sold by LICENSEE and all SUBLICENSEES
and AFFILIATES:
|
|
(d)
|
deductions
applicable as provided in Paragraph
1.18;
|
|
(e)
|
royalties
due on additional payments from SUBLICENSEES under Paragraph
3.1.d;
|
|
(f)
|
any
minimum annual royalty payment credits applicable against running
royalties;
|
|
(g)
|
total
royalties due; and
|
|
(h)
|
names
and addresses of all SUBLICENSEES.
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6.4 On
or
before 90 days following the close of LICENSEE's fiscal year, LICENSEE shall
provide LICENSOR with LICENSEE's certified financial statements for the
preceding fiscal year including, at a minimum, a Balance Sheet and an Operating
Statement.
ARTICLE
7 - PATENT PROSECUTION
7.1 LICENSEE
shall be responsible for all past, present and future costs of filing,
prosecution and maintenance of any and all United States and foreign patent
applications and patents contained in the PATENT RIGHTS. All undisputed expenses
relating to such patent prosecution shall be due and payable within thirty
(30)
days of receipt of invoice from LICENSOR for such expenses. Any and all such
United States and foreign patent applications, and resulting issued patents,
shall remain the property of the LICENSOR unless LICENSEE has an ownership
interest or acquires an ownership interest in such applications and
patents.
7.2 The
costs
described in Article 7.1 shall include, but are not limited to, any past,
present and future taxes, government fees, patent attorney fees, annuities,
working fees, maintenance fees, renewal and extension charges. Payment of such
costs shall be made by reimbursement to the LICENSOR.
7.3 All
new
and existing patent applications under the LICENSED PATENTS shall be prepared,
prosecuted, filed and maintained by patent counsel selected by LICENSEE and
which is reasonably acceptable to the LICENSOR. LICENSEE shall be responsible
for directing prosecution. With respect to any LICENSED PATENTS, LICENSEE and
patent counsel shall:
(a) consult
with the LICENSOR and keep the LICENSOR fully informed of the progress of all
patent applications and patents, including all issues relating to the
preparation, filing, prosecution and maintenance of PATENTRIGHTS;
(b) consult
with the LICENSOR and keep the LICENSOR fully informed about LICENSEE’s patent
strategy with respect to the PATENT RIGHTS;
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(c) provide
to the LICENSOR advance copies of documents relevant to preparation, filing,
prosecution and maintenance of the PATENT RIGHTS sufficiently in advance of
filing to allow the LICENSOR a reasonable opportunity to review and comment
on
such documents; and
(d) provide
the LICENSOR with final copies of such documents. LICENSEE agrees to use
COMMERCIALLY REASONABLE EFFORTS to obtain broad and strong patent protection
in
the best interest of the LICENSOR and LICENSEE. LICENSEE will not finally
abandon any patent application, or make decisions that would have a material
impact on the nature or scope of any claims without the LICENSOR’ consent.
7.4 LICENSEE
shall apply, and shall require SUBLICENSEES to apply, the patent marking notices
required by the law of any country where such LICENSED PRODUCTS are made, sold,
used or shipped, including, but not limited to, the applicable patent laws
of
that country.
ARTICLE
8 - INFRINGEMENT
8.1 LICENSEE
or its SUBLICENSEE(s) has the right to prosecute in their own name and at their
own expense any infringement of the PATENT RIGHTS, so long as the license is
exclusive when the legal action is commenced. LICENSOR agrees to notify LICENSEE
promptly of each infringement of the PATENT RIGHTS of which LICENSOR becomes
aware. Before LICENSEE or its SUBLICENSEES commences an action for infringement,
LICENSEE or SUBLICENSEE shall notify LICENSOR and carefully consider the views
of LICENSOR and the public interest.
8.2 LICENSOR
agrees to join, subject to the approval of the Ohio Attorney General, as a
party
plaintiff in any lawsuit initiated by LICENSEE, if requested by LICENSEE, with
all costs, attorney fees and expenses to be paid by LICENSEE.
8.3 If
LICENSEE undertakes to enforce and/or defend the PATENT RIGHTS by litigation,
LICENSEE may withhold up to [***] percent ([***]%) of the payments otherwise
thereafter due during the course of such litigation to LICENSOR under Article
3.
LICENSEE may apply the amounts withheld to reimburse up to half of LICENSEE's
litigation expenses, including reasonable attorneys’ fees. If LICENSEE recovers
damages in the patent litigation, the award shall be applied first to satisfy
LICENSOR’s and LICENSEE’S unreimbursed expenses and legal fees for the
litigation, and next to reimburse LICENSOR for any payments under Article 3
which are past due or were withheld pursuant to this Article 8. The remaining
balance shall be shared in accordance with the percentages described in Section
4.3, except for such amounts attributable for lost sales which amounts shall
be
paid in accordance with earned royalties described in Section 3.3.
8.4 No
settlement, consent judgment or other voluntary final disposition of the suit
may be entered into without LICENSOR’s consent, which shall not be unreasonably
withheld.
8.5 If
LICENSEE and its SUBLICENSEE(s) elect not to exercise their right to prosecute
or defend an infringement of the PATENT RIGHTS, LICENSOR may do so at its own
expense, controlling such action and retaining all recoveries.
8.6 If
a
declaratory judgment action alleging invalidity of any of the PATENT RIGHTS
is
brought against LICENSEE or LICENSOR, then LICENSOR, at its sole option, has
the
right to intervene and take over the defense of the action at its own
expense.
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ARTICLE
9 - PRODUCT LIABILITY
9.1 LICENSEE
shall at all times during the term of this Agreement and thereafter, indemnify,
defend and hold LICENSOR, its trustees, directors, officers, employees and
affiliates, (collectively, the “Indemnitees”) harmless against all claims,
proceedings, demands and liabilities of any kind whatsoever, including legal
expenses and reasonable attorneys' fees, arising out of the death of or injury
to any person or persons or out of any damage to property, or resulting from
the
production, manufacture, sale, use, lease, consumption or advertisement of
the
LICENSED PRODUCT(s) and/or LICENSED PROCESS(es) or arising from any obligation
of LICENSEE under this Agreement, except claims that the PATENT RIGHTS infringe
third party intellectual property and those arising out of the gross negligence
or willful misconduct of LICENSOR, breach of warranty by LICENSOR, or breach
of
Article 10 by LICENSOR.
9.2 LICENSEE
shall purchase and maintain in effect and shall require its SUBLICENSEES to
purchase and maintain in effect a policy of commercial, general liability
insurance to protect the LICENSOR with respect to events described in Section
9.1. Such insurance shall:
(a) list
LICENSOR as an additional insured under the policy;
(b) provide
that such policy is primary and not excess or contributory with regard to other
insurance the LICENSOR may have;
(c) be
endorsed to include product liability coverage in amounts no less than [***]
dollars ($[***]) per incident and [***] dollars ($[***]) annual aggregate;
and
(d) be
endorsed to include contractual liability coverage for LICENSEE’S
indemnification under Section 9.1;
(e) by
virtue
of the minimum amount of insurance coverage required under Section 9.2(c),
not
be construed to create a limit of LICENSEE’S liability with respect to its
indemnification under Section 9.1.
(f) maintain
such commercial general liability insurance beyond the expiration or termination
of this Agreement during (i) the period that any product, process, or service
relating to, or developed pursuant to, this Agreement is being commercially
distributed or sold by LICENSEE or a SUBLICENSEE or agent of LICENSEE and (ii)
a
reasonable period thereafter the period referred to Paragraph 9.2.d.i above
which in no event shall be less than ten (10) years
9.3 By
signing this Agreement, LICENSEE certifies that the requirements of Section
9.2
will be met on or before the earlier of (a) the date of FIRST SALE of any
LICENSED PRODUCT or (b) the date any LICENSED PRODUCT is tested or used on
humans, and will continue to be met thereafter. Upon LICENSOR’s request,
LICENSEE shall furnish a Certificate of Insurance and a copy of the current
Insurance Policy to the LICENSOR. LICENSEE shall give thirty (30) days’ written
notice to LICENSOR prior to any cancellation of or material change to the
policy.
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9.4 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR, ITS TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT
NOT
LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENT RIGHTS CLAIMS ISSUED OR PENDING, AND THE ABSENCE OF LATENT
OR
OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL
BE
CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY LICENSOR THAT THE
PRACTICE BY LICENSEE OF THE LICENSE GRANTED SHALL NOT INFRINGE THE PATENT RIGHTS
OF ANY THIRD PARTY. LICENSOR, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES
AND
AFFILIATES SHALL NOT BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY
KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS,
REGARDLESS OF WHETHER LICENSOR IS ADVISED, HAS OTHER REASON TO KNOW, OR IN
FACT
DOES KNOW OF THE POSSIBILITY.
ARTICLE
10 –
CONFIDENTIALITY
10.1 During
the course of this Agreement, LICENSOR and LICENSEE may provide each other
with
CONFIDENTIAL INFORMATION. All CONFIDENTIAL INFORMATION shall be designated
in
writing as such by the discloser. LICENSOR and LICENSEE each intend to maintain
the confidential status of their CONFIDENTIAL INFORMATION. Each shall exercise
reasonable care to protect the CONFIDENTIAL INFORMATION from disclosure to
third
parties; no such disclosure shall be made without the other’s written
permission. Upon termination or expiration of this Agreement, LICENSOR and/or
LICENSEE shall comply with the other’s written request to discontinue using
and/or return all CONFIDENTIAL INFORMATION. This Article 10 shall continue
for a
period of five (5) years following the termination or expiration of this
Agreement.
ARTICLE
11 – PUBLICATION
11.1 In
the
event that LICENSOR or the INVENTORS desires to publish or disclose, by written,
oral or other presentation, any material information related to the INVENTION,
the PATENT RIGHTS, or any LICENSED PRODUCT or LICENSED PROCESS, or results
relating to the clinical or non-clinical testing of any of the foregoing,
LICENSOR shall notify LICENSEE in writing of their intention no less
than
60 days
prior to any speech, lecture or other oral presentation,
or any
written or other publication or disclosure and cooperate fully with LICENSEE
to
file any patent applications related to subject matter of the disclosure prior
to the disclosure.
11.2 LICENSOR
shall include with any such notice pursuant to Section 11.1 a description of
any
proposed oral presentation or, in any proposed written or other disclosure,
a
current draft of such proposed disclosure or abstract.
11.3 LICENSEE
may request that LICENSOR, no later than 30 days following the receipt of such
notice, delay such publication or disclosure in order to enable LICENSEE to
file, or have filed on its behalf, a patent application, copyright or other
appropriate form of intellectual property protection related to the information
to be disclosed. Upon receipt of such notice, LICENSOR shall arrange for a
delay
in publication or disclosure until such time as LICENSEE has filed on LICENSOR’s
name and behalf such patent application, copyright or other appropriate form
of
intellectual property protection that LICENSEE agrees to file as soon as is
reasonably practicable provided, however that said deferral shall not exceed
60
days from the receipt of such notice.
11.4 If
LICENSOR does not receive any request to delay publication or disclosure
pursuant to Section 11.3, LICENSOR may submit such material for publication
or
presentation or make such other publication or disclosure.
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ARICLE
12 – USE OF NAME
Each
party shall obtain the prior written approval of the other prior to making
use
of the name of the other party nor any variation or adaptation thereof for
any
commercial purpose, except as required to comply with law, regulation or court
order.
ARICLE
13 - TERMINATION
13.1 LICENSOR
shall have the right to terminate this Agreement pursuant to the provisions
below, provided that LICENSOR has given LICENSEE the notice required in
accordance with Section 13.2 and LICENSEE has failed to cure the breach
described in such notice:
(a) breach
by
LICENSEE of a material term of the Agreement;
(b) the
institution of any proceeding by LICENSEE under any bankruptcy, insolvency,
or
moratorium law;
(c) any
assignment by LICENSEE of substantially all of its assets for the benefit of
creditors;
(d) placement
of LICENSEE’s assets in the hands of a trustee or a receiver unless the
receivership or trust is dissolved within 30 days thereafter and provided that
in the case of an involuntary bankruptcy proceeding, which is contested by
LICENSEE, such termination shall not become effective until the bankruptcy
court
of jurisdiction has entered an order upholding the petition; or
(f)
a
decision by LICENSEE or LICENSEE’s licensee or assignee of rights under this
Agreement to quit the business of developing or selling LICENSED PRODUCTS.
13.2 LICENSOR
may exercise its rights pursuant to Section 13.1 above by giving LICENSEE ninety
(90) days' prior written notice (the “Written Notice”) of LICENSOR's intention
to terminate. Such notice shall include the basis for such termination. Upon
the
expiration of such period, LICENSOR shall provide written notice of termination
to LICENSEE (the “Termination Notice”), effective upon receipt, unless LICENSEE
has cured the material breach or the other basis for such proposed termination
during such ninety (90) day period. Such notice and termination shall not
prejudice LICENSOR's right to receive Earned Royalties accrued prior to
termination, or other sums due hereunder and shall not prejudice any cause
of
action or claim of LICENSOR accrued or to accrue on account of any breach or
default by LICENSEE.
13.3 LICENSEE
shall have the right to terminate this Agreement pursuant to the provisions
below, provided that LICENSEE has given LICENSOR the notice required in
accordance with Section 13.4:
(a) LICENSEE
may terminate this Agreement upon breach by LICENSOR of a material term of
the
Agreement; or
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(b) LICENSEE
may terminate this Agreement at any time upon written notice of termination
given to LICENSOR at least ninety (90) days prior to the date of such
termination and upon:
|
(i)
|
the
payment of all amounts due LICENSOR through the effective date of
the
termination;
|
|
(ii)
|
submission
of a final report of the type described in Paragraph
6.3;
|
|
(iii)
|
suspension
of LICENSEE’s use of the LICENSED PROCESS(ES) and LICENSED PRODUCT(S)
(subject to Paragraph 13.5 below);
|
13.4 LICENSEE
may exercise its right of termination pursuant to Section 13.3(a), by giving
LICENSOR 90 days prior written notice of LICENSEE’s intent to terminate setting
forth the basis of such termination. Upon the expiration of the 90 day period,
LICENSEE shall provide written notice of termination to LICENSOR, effective
upon
receipt, unless LICENSOR has cured the breach or the other basis for such
proposed termination during such 90 day period. Such notice of termination
shall
not prejudice any cause of action or claim of LICENSEE accrued or to accrue
on
account of any breach or default by LICENSOR.
13.5 If
LICENSEE has filed patent applications or obtained patents to any modification
or improvement to LICENSED PRODUCTS or PROCESSES within the scope of the PATENT
RIGHTS, LICENSEE agrees upon request to enter into good faith negotiations
with
LICENSOR or its future licensee(s) for the purpose of granting licensing rights
to said modifications or improvements in timely fashion and under commercially
reasonable terms.
13.6 Termination
of this Agreement shall not release LICENSOR and LICENSEE from any obligation
that matured prior to the effective date of such termination. Articles 1, 9,
10,
13 and 16 shall survive termination. LICENSEE and any SUBLICENSEE may, however,
after the effective date of such termination, complete and sell LICENSED
PRODUCTS in the process of manufacture and sell all LICENSED PRODUCTS already
in
existence at the time of termination, if LICENSEE pays LICENSOR as required
by
Article 3 and submits the reports required by Article 6 of this
Agreement.
13.7 The
failure of either Party, at any time, or for any period of time, to enforce
any
of the provisions of this Agreement, shall not be construed as a waiver of
such
provisions or as a waiver of the right of either Party’s thereafter to enforce
each and every such provision of this Agreement.
ARTICLE
14 - PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
14.1 Any
payment, notice or other communication required by this Agreement shall be
sufficiently made or given on the date of mailing if sent by recognized express
carrier or certified first class mail, postage prepaid, addressed to LICENSOR
or
LICENSEE at its address below or as it designates by written notice to the
other.
|
For
LICENSOR:
|
Technology
Licensing & Commercialization
|
|
The
Ohio State University
|
|
|
▇▇▇▇
▇▇▇▇▇ ▇▇▇▇
|
|
|
▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇-▇▇▇▇
|
|
|
(▇▇▇)
▇▇▇-▇▇▇▇; FAX (▇▇▇) ▇▇▇-▇▇▇▇
|
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For
LICENSEE:
|
|
|
President
|
|
|
▇▇
▇▇▇ ▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇ ▇▇▇
|
|
|
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
|
|
Tel:
(▇▇▇) ▇▇▇-▇▇▇▇
|
|
|
Fax:
(▇▇▇) ▇▇▇-▇▇▇▇
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ARTICLE
15 - REPRESENTATIONS AND WARRANTIES
15.1 LICENSEE
represents and warrants to LICENSOR that:
(a) LICENSEE
is a duly organized and validly existing corporation under the laws of the
State
of Delaware with adequate power and authority to conduct the business in which
it is now engaged or currently proposed to be engaged, and LICENSEE is duly
qualified to do business as a foreign corporation and is in good standing in
such other states or jurisdictions as is necessary to enable it to carry on
its
business or own its properties.
(b) To
the
best of LICENSEE’s knowledge, there are no actions, suits, or proceedings
pending or threatened against or affecting LICENSEE, its officers or directors
in their capacity as such, its properties, or its patents in any court or before
any governmental or administrative agency, which can have any material adverse
effect on the business as now conducted or as currently proposed to be
conducted, on the properties, the financial condition, or income of LICENSEE,
or
the transactions contemplated by this Agreement and LICENSEE is not in default
under any order or judgment of any court or governmental or administrative
agency.
(c) Consummation
of the transactions contemplated by this Agreement in compliance with provisions
of this Agreement will not result in any breach of any of the terms, conditions,
or provisions of, or constitute a default under, or result in the creation
of
any lien, charge, or encumbrance on, any property or assets of LICENSEE pursuant
to any indenture, mortgage, deed of trust, agreement, corporate charter, bylaws,
contract, or other instrument to which LICENSEE is a party or by which Licensee
may be bound or any law, rule, regulation, qualification, license, order or
judgment applicable to Licensee or any of its property.
15.2 LICENSOR
represents and warrants to LICENSEE that as of the EFFECTIVE DATE:
(a) LICENSOR
has the full right and power to perform the obligations and grant the LICENSE
set forth in this Agreement;
(b) there
are
no outstanding agreements, assignments or encumbrances in existence inconsistent
with the provisions of this Agreement;
(c) except
as
listed in Schedule 15.2(c), LICENSOR has not authorized in any manner any Third
Party to practice the PATENT RIGHTS;
(d) except
as
required pursuant to Section 2.5, LICENSOR owns or possesses all right, title,
and interest in and to the PATENT RIGHTS, including exclusive, irrevocable
right, title and interest thereto, free and clear of all liens, charges,
encumbrances or other restrictions or limitations of any kind whatsoever;
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(e) there
are
no licenses, options, restrictions, liens, rights of third parties, disputes,
proceedings or claims relating to, affecting, or limiting its rights or the
rights of LICENSEE under this Agreement with respect to, or which (i) may lead
to a claim of infringement or invalidity regarding, any part or all of the
PATENT RIGHTS and their use as contemplated in the underlying patent
applications as presently drafted or (ii) imposes obligations upon LICENSOR
or
gives any rights to LICENSOR which, in either case, would adversely affect
the
rights of LICENSEE or the obligations of LICENSOR under this Agreement;
(f) except
as
listed in Schedule 15.2(f) and to the best of LICENSOR’s knowledge and belief
there is no claim, pending or threatened, of infringement, interference or
invalidity regarding, any part or all of the PATENT RIGHTS and their use as
contemplated in the underlying patent applications as presently drafted or
as
contemplated under this Agreement;
(g) except
as
listed in Schedule 15.2(g), Appendix
A
lists
all patents issued and patent applications filed on or before the Effective
Date
of this Agreement within the scope of the PATENT RIGHTS and therefore subject
to
this Agreement and all of the inventors named in the patents and patent
applications listed in Appendix
A
have
assigned, or are under an obligation to assign, to LICENSOR all of their right,
title an interest in the inventions claimed.
ARTICLE
16 -
MISCELLANEOUS PROVISIONS
16.1 This
Agreement shall be construed, governed, interpreted and applied according to
Ohio law, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent was
granted. LICENSOR and LICENSEE shall initially attempt in good faith to resolve
any significant controversy, claim, or dispute arising out of or relating to
this Agreement or significant breach thereof (hereinafter referred to as a
“Dispute”) through at least one face-to-face negotiations between the Parties at
a mutually convenient place. If the Dispute is not resolved within thirty (30)
business days (or such other period of time mutually agreed upon by the parties)
of commencing such face-to-face negotiations, or if no such face-to-face meeting
occurs within thirty (30) business days from the date of notice of a Dispute,
then the Parties agree that the Dispute shall be submitted to a binding
arbitration in accordance with the rules of the American Arbitration
Association. Venue of arbitration shall be in Columbus, Ohio.
16.2 LICENSOR
and LICENSEE acknowledge that this Agreement sets forth their entire
understanding concerning the subject matter of this Agreement, and no
modification of the Agreement will be effective unless both LICENSOR and
LICENSEE agree to it in writing.
16.3 The
provisions of this Agreement are severable. If any provisions of this Agreement
are determined invalid or unenforceable under any controlling body of law,
such
invalidity or unenforceability shall not affect the validity or enforceability
of the remaining provisions.
16.4 LICENSEE
agrees to ▇▇▇▇ the LICENSED PRODUCTS sold in the United States with all
applicable United States patent numbers. All LICENSED PRODUCTS shipped to or
sold in other countries shall be marked to comply with the patent laws and
practice of the country of manufacture or sale.
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16.5 The
failure of either LICENSOR or LICENSEE to assert a right or insist upon
compliance with any term or condition of this Agreement shall not constitute
a
waiver of that right or excuse a similar subsequent failure to perform any
such
term or condition by the other.
16.6 LICENSEE
agrees to comply with all applicable laws and regulations. In particular,
LICENSEE understands and acknowledges that the transfer of certain commodities
and technical data is subject to United States laws and regulations controlling
the export of such commodities and technical data, including all Export
Administration Regulations of the United States Department of Commerce. These
laws and regulations prohibit or require a license for the export of certain
types of technical data to certain specified countries. LICENSEE agrees to
comply with all United States laws and regulations controlling the export of
commodities and technical data, to be solely responsible for any violation
of
such laws and regulations by LICENSEE or its SUBLICENSEES, and to defend and
hold LICENSOR harmless if any legal action of any nature results from the
violation.
16.8 This
Agreement may not be amended or modified except by written agreement executed
by
each of the parties. Other than in the event of a CHANGE OF CONTROL (as defined
herein) LICENSOR'S prior written consent, which shall not be unreasonably
withheld, shall be required prior to any other assignment of LICENSEE’S rights
or obligations under this Agreement. Following any such assignment or CHANGE
OF
CONTROL, the surviving corporation shall assume all of the rights and
obligations included in this Agreement. Any attempted assignment in
contravention of this Article 16.8 shall be null and void and shall constitute
a
material breach of this Agreement. LICENSOR'S prior written consent, which
shall
not be unreasonably withheld, shall be required prior to any other assignment
of
LICENSEE’S rights or obligations under this Agreement.
16.9 In
the
event any Party hereto is prevented from or delayed in the performance of any
of
its obligations hereunder (other than the payment of monies due and owing)
by
reason of acts of God, war, terrorism, strikes, riots, storms, fires, electrical
or telecommunications outages or any other cause whatsoever beyond the
reasonable control of the Party, the Party so prevented or delayed shall be
excused from the performance of any such obligation to the extent and during
the
period of such prevention or delay, provided that such Party takes all
reasonable steps to overcome such cause(es) as soon as is reasonably
possible.
16.10
Nothing contained in this Agreement will be deemed to place the parties in
a
partnership, joint venture or agency relationship and neither party will have
the right or authority to obligate or bind the other party in any
manner.
16.11
This Agreement may be executed in two or more counterparts, each of which will
be deemed an original, but all of which taken together will constitute one
and
the same instrument.
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The
authorized signatures of LICENSOR and LICENSEE below signify their acceptance
of
the terms of this Agreement.
|
THE
OHIO STATE UNIVERSITY
|
||||
|
RESEARCH
FOUNDATION
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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Date:
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