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. EXCLUSIVE LICENSE AGREEMENT
Exhibit
10.5
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 made and entered into as of the 25th day of October, 2006
(“Effective Date”), by and between the University of Pittsburgh – Of the
Commonwealth System of Higher Education, a non-profit corporation organized
and
existing under the laws of the Commonwealth of Pennsylvania, with an office
at
200 Xxxxxxx Steel Conference Center, Thackeray and O’Xxxx Xxxxxxx, Xxxxxxxxxx,
Xxxxxxxxxxxx 00000 (“University”), and Arno Therapeutics, Inc., with its
principal business at 000 Xxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, XX 00000
(“Licensee”).
WHEREAS,
University and The University of Kentucky (“Kentucky”) are joint-owners by
assignment of certain Patent Rights, entitled “Camptothecin Analogs and Methods
of Preparation Thereof,” developed by Drs. Xxxxxx Xxxxxx and others of
University faculty and Dr. Xxxxxx Xxxxx and others of Kentucky faculty;
WHEREAS,
University and Kentucky have executed an Inter-Institutional Agreement, dated
as
of December 15, 2000, which grants University certain rights with respect to
the
licensing of Patent Rights which are jointly owned;
WHEREAS,
both University and Kentucky desire to have the Patent Rights utilized in the
public interest;
WHEREAS,
Licensee has represented to University that Licensee is experienced in the
development, production, manufacture, marketing and sale of products and/or
the
use of similar products to the Licensed Technology and that Licensee shall
commit itself to a thorough, vigorous and diligent program of exploiting the
Patent Rights so that public utilization results therefrom; and
WHEREAS,
Licensee desires to obtain a license under the Patent Rights upon the terms
and
conditions hereinafter set forth.
NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein, the parties hereto, intending to be legally bound, agree as
follows:
ARTICLE
1 – DEFINITIONS
For
purposes of this Agreement, the following words and phrases shall have the
following meanings:
|
1.1
|
“Affiliate”
shall mean, (a) with respect to the University, any clinical or research
entity that is operated or managed as a facility under the UPMC Health
System, whether or not owned by University, and (b) with respect
to the
Licensee, any corporation or non-corporate business entity which
controls,
is controlled by, or is under common control with the Licensee. A
corporation or non-corporate business entity shall be regarded as
in
control of another the Licensee if Licensee owns, or directly or
indirectly controls, at least fifty percent (50%) of the voting stock
of
the other corporation, or (i) in the absence of the ownership of
at least
fifty percent (50%) of the voting stock of a corporation or (ii)
in the
case of a non-corporate business entity, or non-profit corporation,
if it
possesses the power to direct or cause the direction of the management
and
policies of such corporation or non-corporate business entity, as
applicable.
|
|
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 merger or consolidation beneficially own, immediately following
the
effective date of such merger, consolidation, acquisition or other
transaction, securities representing less than fifty percent (50%)
of the
combined voting power of the surviving corporation’s then outstanding
voting securities.
|
|
1.3
|
“FDA”
shall mean the United States Food and Drug Administration or successor
entity.
|
|
1.4
|
“Field”
shall mean all therapeutic uses in humans and animals.
|
|
1.5
|
“First
Commercial Sale” shall mean the first sale of a Licensed Technology to a
third party after approval of an NDA for a Licensed Technology by
the
FDA.
|
|
1.6
|
“Licensee”
shall mean Arno Therapeutics, Inc., a Delaware corporation, and all
entities at least fifty percent (50%) owned or controlled by such
company.
|
|
1.7
|
“Licensed
Technology” shall mean any product or part thereof or process which
is:
|
|
(a)
|
Covered
in whole or in part by an issued, unexpired or pending claim contained
in
the Patent Rights in the country in which any such product or part
thereof
is made, used or sold or in which any such process is used or sold;
and
|
|
(b)
|
Manufactured
by using a process or is employed to practice a process which is
covered
in whole or in part by an issued, unexpired claim or a pending claim
contained in the Patent Rights in the country in which any such process
that is included in Licensed Technology is used or in which such
product
or part thereof is used or sold.
|
|
1.8
|
“NDA”
shall mean a New Drug Application filed in the United States with
the
FDA.
|
|
1.9
|
“Net
Sales” shall mean the
total invoice price for sales of a Licensed Product by
or on behalf of the Licensee, its Affiliates, and/or their sublicensees,
and gross receipts from leasing, renting, or otherwise making a Licensed
Product available to others for profit without sale or other dispositions,
whether invoiced or not, less the
following:
|
(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 (but excluding any income taxes paid by Licensee);
(d)
outbound transportation prepaid or allowed; and
(e)
transportation insurance separately stated on the invoice.
|
1.10
|
“Non-Commercial
Education and Research Purposes” shall mean use of Patent Rights
(including distribution of biological materials covered by the Patent
Rights) for academic research or other not-for-profit scholarly purposes
which are undertaken at a nonprofit or governmental institution that
does
not use the Patent Rights in the production or manufacture of products
for
sale or the performance of services for a fee or is under any obligation
to use the Patent Rights in connection with or on behalf of a for-profit
entity. University shall include Licensee as an indemnified party
in any
Material Transfer Agreement that distributes materials covered by
the
Patent Rights.
|
|
1.11
|
“Non-Royalty
Sublicense Income” shall mean execution fees, maintenance fees, milestone
fees and all other non-royalty payments received by Licensee from
its
sublicensees pursuant to any sublicense granted pursuant to Section
2.3
hereunder.
|
|
1.12
|
“Patent
Rights” shall mean University intellectual property described below and
assigned to the University:
|
|
(a)
|
The
United States and foreign patents and/or patent applications listed
in
Exhibit A including any and all direct and indirect divisions,
continuations and continuations-in-part of said patents and/or
application, and any and all Letters Patent in the United States
and all foreign countries which may be granted therefor and thereon,
and
reissues, reexaminations and extensions of said Letters Patent, and
all
rights under the International Convention for the Protection of Industrial
Property including all rights of
priority;
|
|
(b)
|
United
States and foreign patents issued from the applications listed in
Exhibit
A and from divisionals and continuations and continuations in part
of
these applications; and
|
|
(c)
|
Claims
of U.S. and foreign continuation in part and divisional applications,
and
of the resulting patents, which are directed to subject matter
specifically described in the U.S. and foreign applications listed
in
Exhibit A.
|
|
1.13
|
“Territory”
shall mean worldwide.
|
ARTICLE
2 - GRANT
|
2.1
|
Subject
to the terms and conditions of this Agreement, University hereby
grants to
Licensee, to the extent it may lawfully do so, the right and exclusive
license in the Territory to make, have made, use, import, and sell
the
Licensed Technology in the Field and to practice under the Patent
Rights
in the Field to the end of the term for which the Patent Rights are
granted, unless this Agreement is terminated sooner as provided herein.
University reserves the royalty-free, nonexclusive right to practice
under
the Patent Rights and to use the Licensed Technology for Non-Commercial
Education and Research Purposes.
|
|
2.2
|
The
license granted hereby is subject to the rights of the United States
government, if any, as set forth in 35 U.S.C. §200, et seq. Pursuant to
this law, the United States government may have acquired a nonexclusive,
nontransferable, paid up license to practice or have practiced for
or on
behalf of the United States the inventions described in the Patent
Rights
throughout the world. Pursuant to 35 U.S.C. §200, et seq. Licensed
Technology produced
for sale in the United States shall be substantially manufactured
in the
United States (unless a waiver under 35 U.S.C. §204 is granted by the
appropriate United States government
agencies).
|
|
2.3
|
Licensee
shall have the right to enter into sublicensing arrangements for
the
rights, privileges and licenses granted hereunder upon prior written
approval of each sublicensee by University, which approval shall
not be
unreasonably withheld. Additionally, sublicensees shall not have
rights to
sublicense, without prior written approval of the University. Licensee
will notify the University of such sublicense agreement within ten
(10)
days following execution of such sublicense. Such sublicense agreements
shall include a royalty rate upon sublicense Net Sales in an amount
at
least equal to the rate set forth in Section 4.l(c). 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.
|
|
2.4
|
Licensee
agrees that any sublicense granted by it shall provide that the
obligations to University of Articles 2, 7, 8, 9, 10, and 13 of this
Agreement shall be binding upon the sublicensee as if it were party
to
this Agreement. Each sublicense granted by Licensee pursuant to this
Agreement shall include an audit right by University of sublicensee
of the
same scope as provided in Section 5.2 with respect to
Licensee.
|
|
2.5
|
Licensee
agrees to forward to University a copy of any and all sublicense
agreements promptly upon execution thereof, but in no event later
than
thirty (30) days after each such sublicense agreement has been executed
by
both parties thereto.
|
|
2.6
|
The
license granted hereunder shall not be construed to confer any rights
upon
Licensee by implication, estoppel or otherwise as to any intellectual
property not specifically set forth in Exhibit A
hereof.
|
ARTICLE
3 – DUE DILIGENCE
|
3.1
|
Licensee
shall use its best efforts to bring the Licensed Technology to market
as
soon as practicable, consistent with sound and reasonable business
practice and judgment, and to continue active, diligent marketing
efforts
for the Licensed Technology throughout the term of this Agreement.
|
|
3.2
|
Licensee
shall recruit a management team of experienced professionals to lead
product development within twelve (12) months of the Effective Date
of
this Agreement. Thereafter, Licensee, its Sublicensee, or their
Affiliates, shall demonstrate ongoing engagement of clinical development
for Licensed Products by conducting at least one of the following
activities within each yearly anniversary of the Effective
Date:
|
|
(a)
|
Expending
at least [***] dollars ($[***]) per year for the for development
of
Licensed Products until the approval of an NDA of a Licensed
Product;
|
|
(b)
|
Manufacturing
or having manufactured Licensed Products for clinical trials under
an
approved IND;
|
|
(c)
|
Enrolling
at least one patient, or being actively engaged in a Phase I Clinical
Trial;
|
|
(d)
|
Enrolling
at least one patient, or being actively engaged in a Phase II Clinical
Trial or the material preparation for a Phase II Clinical
Trial;
|
|
(e)
|
Enrolling
at least one patient, or being actively engaged in a Phase III Clinical
Trial or the material preparation for a Phase III Clinical
Trial;
|
|
(f)
|
Submitting
an NDA filing for a Licensed
Product;
|
|
(g)
|
Following
the submission of an NDA, actively pursuing NDA approval for a Licensed
Product; or
|
|
(h)
|
Following
NDA approval of a Licensed Product, launching, marketing or selling
a
Licensed Product; and
|
|
(i)
|
Following
first commercial sale of a Licensed Product, actively maintaining
marketing and selling efforts of Licensed
Products.
|
|
3.3
|
Licensee’s
failure to perform in Sections 3.1 and 3.2 hereof shall be considered
a
material breach of Agreement the License and grounds for University
to
terminate this Agreement pursuant to Section 11.1(a) 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.
|
ARTICLE
4 – LICENSE CONSIDERATION
|
4.1
|
In
consideration of the rights, privileges and license granted by University
hereunder, Licensee shall pay royalties and other monetary consideration
as follows:
|
|
(a)
|
Initial
license fee, nonrefundable and noncreditable against royalties,
of three hundred fifty thousand dollars ($350,000) due within
fifteen (15) days of the date of University’s invoice therefor;
|
|
(b)
|
One
million Five Hundred Thousand dollars ($1,500,000)upon the acceptance
by the FDA of the first New Drug Application (“NDA”) for a Licensed
Technology;
|
|
(c)
|
Two million
Five Hundred Thousand dollars ($2,500,000) upon the approval by the
FDA of
the first NDA for a Licensed
Technology;
|
|
(d)
|
Annual
maintenance fees, non-refundable and non-creditable against royalties,
as
follows:
|
|
(i)
|
[***]
dollars ($[***]) on the first and second anniversary of the Effective
Date
of the Agreement;
|
|
(ii)
|
[***]
dollars ($[***]) on the third and fourth anniversary of the Effective
Date
of the Agreement;
|
|
(iii)
|
[***]
dollars ($[***]) on the fifth and sixth anniversary of the Effective
Date
of the Agreement; and
|
|
(iv)
|
[***]
dollars ($[***]) on the seventh anniversary of the Effective Date
of the
Agreement and each anniversary thereafter.
|
|
(e)
|
Royalties
in an amount equal to [***] percent ([***]%) of Net Sales of the
Licensed
Technology per calendar quarter;
|
|
(f)
|
Following
the year in which Licensee makes its First Commercial Sale, Minimum
royalty in the amount of [***] dollars ($[***]) per calendar year
if such
minimum royalty is greater than the aggregate annual royalty computed
in
accordance with Section 4.1(c) above;
and
|
|
(g)
|
A
share of Non-Royalty Sublicense Income as
follows:
|
|
(i)
|
[***]
percent ([***]%) of the Non-Royalty Sublicense Income for sublicenses
executed before the third anniversary of the Effective Date of this
Agreement;
|
|
(ii)
|
[***]
percent ([***]%) of the Non-Royalty Sublicense Income for sublicenses
executed after the third anniversary of the Effective Date of this
Agreement;
|
|
4.2
|
All
payments pursuant to this Agreement may be made by check or by wire
transfer (along with applicable wire transfer fees) in United States
dollars without deduction or exchange, collection or other charges
and
directed to the address or, in the case of wire transfer, to the
bank, set
forth in Article 11. Annual maintenance payments pursuant to Section
4.1(b) hereof shall be paid on the anniversary of the Effective Date
of
the calendar year in which they are due. Royalty payments pursuant
to
Section 4.1(c) hereof shall be due within thirty (30) days after
each
March 31, June 30, September 30 and December 31. Minimum annual
royalties pursuant to Section 4.1(d) shall be paid by December 15
of the
calendar year in which they are due. Non-Royalty Sublicense Income
payments pursuant to Section 4.1(e) hereof shall by paid within thirty
(30) days after receipt of payment by Licensee from
sublicense.
|
|
4.3
|
Payments
pursuant to this Agreement, including those specified in Section
6.2,
which are overdue shall bear interest calculated from the due date
until
payment is received at the rate of [***] percent ([***]%) per annum,
or
the prime rate (as quoted by The Wall Street Journal) plus [***]
percent
([***]%), whichever is higher. Payment of such interest by Licensee
shall
not negate or waive the right of University to seek any other remedy,
legal or equitable, to which it may be entitled because of the delinquency
of any payment, including, but not limited to, termination of this
Agreement as set forth in Article 10.
|
|
4.4
|
Licensee
shall sell products and/or processes resulting from Licensed Technology
to
University and its Affiliates upon request at such price(s) and on
such
terms and conditions as such products and/or processes are made available
to Licensee’s most favored
customer.
|
ARTICLE
5 – REPORTS
|
5.1
|
Within
thirty (30) days after each March 31, June 30, September 30 and December
31 of each year during the term of this Agreement beginning in the
year of
the first commercial sale of Licensed Technology, Licensee shall
deliver
to University true, accurate and detailed reports of the following
information in a form acceptable to
University:
|
|
(a)
|
Number
of Licensed Technology products manufactured and sold by Licensee
and all
sublicensees;
|
|
(b)
|
Total
xxxxxxxx for all such products;
|
|
(c)
|
Accounting
for all Licensed Technology processes used or sold by Licensee and
all
sublicensees;
|
|
(d)
|
Deductions
set forth in Section 1.5;
|
|
(e)
|
Total
royalties due;
|
|
(f)
|
Name
and addresses of sublicensees; and
|
|
(g)
|
Total
Non-Royalty Sublicense Income received during such calendar quarter
and
total amount of payment due pursuant to Section 4.1(e).
|
|
5.2
|
Licensee
shall keep full, true and accurate books of account, in accordance
with
generally accepted accounting principles, containing all information
that
may be necessary for the purpose of showing the amounts payable to
University hereunder. Such books of account shall be kept at Licensee’s
principal place of business. Such books and the supporting data related
thereto shall be open at all reasonable times for three (3) years
following the end of the calendar year to which they pertain to the
inspection of University or its agents for the purpose of verifying
Licensee’s royalty statement or compliance in other respects with this
Agreement. The fees and expenses of University’s representatives shall be
borne by University; however, if an error of more than [***] percent
([***]%) of the total payments due or owing for any year is discovered,
then Licensee shall bear the fees and expenses of University’s
representatives.
|
|
5.3
|
No
later than sixty (60) days after December 31 of each calendar year
during
the term of this Agreement, Licensee shall provide to University
a written
annual progress report, describing Licensee’s progress on research and
development, regulatory approvals, manufacturing, sublicensing, marketing
and sales during the preceding twelve-month period ending December
31.
|
ARTICLE
6 – PATENT PROSECUTION
|
6.1
|
University
has or shall apply for, seek prompt issuance of and maintain during
the
term of this agreement the Patent Rights in the United States and
in such
foreign countries as may be designated by the Licensee in a written
notice
to University within a reasonable time in advance of the required
filing
dates. In this respect, University shall inform Licensee, with sufficient
notice such that Licensee may take appropriate action, of approaching
deadlines for foreign filings, including but not limited to national
phase
entry deadlines. Licensee shall have the opportunity to advise and
cooperate with University in the selection of patent counsel, and
in the
prosecution, filing and maintenance of Patent Rights. After the effective
date of this agreement, University shall take no action on patent
prosecution of Patent Rights without the prior written authorization
of
Licensee; provided, however that in the absence of such authorization,
University may take timely action, if the result of not doing so
would be
the loss of the Patent Rights. Licensee may request of University
that
responsibility for filing and prosecution of Patent Rights be transferred
by University to counsel selected by Licensee, and University will
grant
such request, provided such counsel shall be acceptable to
University.
|
|
6.2
|
All
fees and costs, including attorneys’ fees, relating to the filing,
prosecution and maintenance of the Patent Rights shall be the
responsibility of Licensee, whether incurred prior to or after the
date of
this Agreement. Such fees and costs incurred by and billed to University
prior to the date hereof, and in the amount of [***] dollars ($[***]),
will be payable by Licensee to University within five (5) business
days
after the execution of this Agreement by Licensee. In no event, however,
shall the Licensee be responsible for payment to University of any
patent
expense covered under this section 6.2 to the extent that University
has
previously been fully reimbursed by one or more third parties. Fees
and
costs incurred after the date of this Agreement, or fees and costs
incurred before, but billed to University after the date of this
Agreement, shall be paid by Licensee within thirty (30) days after
receipt
of University’s invoice therefor. Payments pursuant to this Section 6.2
are not creditable against
royalties.
|
ARTICLE
7 – INFRINGEMENT ACTIONS
|
7.1
|
Licensee
shall inform University promptly in writing of any alleged infringement
of
the Patent Rights by a third party and of any available evidence
thereof.
|
|
7.2
|
During
the term of this Agreement, Licensee shall have the right, but shall
not
be obligated, to prosecute at its own expense all infringements of
the
Patent Rights in the Field if Licensee has notified University in
writing
of its intent to prosecute; provided, however, that such right to
bring
such an infringement action shall remain in effect only for so long
as the
license granted herein remains exclusive. In furtherance of such
right,
University hereby agrees that Licensee may include University as
a party
plaintiff in any such suit, without expense to University. The total
cost
of any such infringement action commenced or defended solely by Licensee
shall be borne by Licensee and University shall receive a percentage
of
any recovery or damages for past infringement derived therefrom which
is
equal to the percentage royalty due University under Article 4. Licensee
shall indemnify University against any order for costs that may be
made
against University in such
proceedings.
|
|
7.3
|
If
within six (6) months after having been notified of any alleged
infringement, Licensee shall have been unsuccessful in persuading
the
alleged infringer to desist and shall not have brought and shall
not be
diligently prosecuting an infringement action, or if Licensee shall
notify
University at any time prior thereto of its intention not to bring
suit
against any alleged infringer, then, and in those events only, University
shall have the right, but shall not be obligated, to prosecute at
its own
expense any infringement of the Patent Rights, and University may,
for
such purposes, use the name of Licensee as party plaintiff. University
shall bear all costs and expenses of any such suit. In any settlement
or
other conclusion, by litigation or otherwise, University shall keep
any
recovery or damages for past infringement derived
therefrom.
|
|
7.4
|
In
the event that a declaratory judgment action alleging invalidity
or
infringement of any of the Patent Rights shall be brought against
University, Licensee, at its option, shall have the right, within
thirty
(30) days after commencement of such action, to intervene and take
over
the sole defense of the action at its own
expense.
|
|
7.5
|
In
any infringement suit either party may institute to enforce the Patent
Rights pursuant to this Agreement, the other party shall, at the
request
and expense of the party initiating such suit, cooperate in all respects
and, to the extent possible, have its employees testify when requested
and
make available relevant records, papers, information, samples, specimens,
and the like.
|
ARTICLE
8 – INDEMNIFICATION/INSURANCE/LIMITATION OF LIABILITY
|
8.1
|
Licensee
shall at all times during the term of this Agreement and thereafter
indemnify, defend and hold Kentucky and University, its trustees,
officers, employees and Affiliates (“University Indemnified Parties”)
harmless against all claims and expenses, including legal expenses
and
reasonable attorneys’ fees (“Claims”), arising out of the death of or
injury to any person or persons or out of any damage to property
or the
environment, and against any other claim, proceeding, demand, expense
and
liability of any kind whatsoever resulting from: (i) the production,
manufacture, sale, use, lease, consumption or advertisement of the
Licensed Technology, (ii) the practice by Licensee or any Affiliate
or
sublicensee of the Patent Rights; or (iii) arising from any obligation
of
Licensee hereunder. Licensee shall provide this defense and indemnity
whether or not any University Indemnified Party, either jointly or
severally, is named as a party defendant and whether or not any University
Indemnified Party is alleged to be negligent or otherwise responsible
for
any injuries to person or property. The obligation of Licensee to
defend
and indemnify as set forth herein shall survive termination of this
Agreement and shall not be limited by any other limitation of liability
elsewhere in this Agreement. Licensee shall not, however, be required
to
indemnify the University Indemnified Parties from any Claims arising
out
of the gross negligence, recklessness or willful misconduct of the
University Indemnified Parties.
|
|
8.2
|
Licensee
shall obtain and carry in full force and effect liability insurance
which
shall protect Licensee, University and Kentucky in regard to events
covered by Section 8.1 above, as provided
below:
|
|
COVERAGE
|
LIMITS
|
||
|
(a)
|
Commercial
General Liability,
|
$[***]
Combined Single
|
|
|
including,
but not limited to,
|
Limits
for Bodily Injury
|
||
|
Products,
Contractual, Fire, Legal
|
and
Property Damage
|
||
|
and
Personal Injury
|
|||
|
(b)
|
Products
Liability
|
$[***]
|
The
University of Pittsburgh is to be named as an additional insured with respect
to
insurance policies identified in Sections 8.2(a) and 8.2(b) above. Certificates
of insurance evidencing the coverage required above shall be filed with the
University’s Office of Risk Management, 1817 Cathedral of Learning, Xxxxxxxxxx,
XX 00000, no later than fifteen (15) days after execution of this Agreement
and
annually thereafter. Such certificates shall provide that the insurer will
give
the University not less than thirty (30) days advance written notice of any
material changes in or cancellation of coverage.
|
8.3
|
UNIVERSITY
AND KENTUCKY 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, AND VALIDITY OF
PATENT
RIGHTS CLAIMS, ISSUED OR PENDING. NOTHING IN THIS AGREEMENT SHALL
BE
CONSTRUED AS A REPRESENTATION OR WARRANTY GIVEN BY UNIVERSITY OR
KENTUCKY
THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL
NOT
INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. UNIVERSITY AND KENTUCKY
ADDITIONALLY DISCLAIM ALL OBLIGATIONS AND LIABILITIES ON THE PART
OF
UNIVERSITY AND KENTUCKY FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO,
DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND
EXPERTS’ FEES, AND COURT COSTS (EVEN IF UNIVERSITY OR KENTUCKY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING
OUT OF
OR IN CONNECTION WITH THE MANUFACTURE, USE OR SALE OF THE PRODUCT(S)
AND
SERVICE(S) LICENSED UNDER THIS AGREEMENT. LICENSEE ASSUMES ALL
RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY A PRODUCT
THAT
IS MANUFACTURED, USED OR SOLD BY LICENSEE (INCLUDING SUBLICENSEE
SALES)
WHICH IS LICENSED TECHNOLOGY HEREUNDER.
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ARTICLE
9 – REPRESENTATIONS AND WARRANTIES
| 9.1 |
Licensee
represents and warrants to University
that:
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(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;
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(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;
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(c)
|
Licensee
has full power and lawful authority to issue and sell the Shares
on the
terms and conditions contained herein; and
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(d)
|
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.
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| 9.2 |
University
hereby represents and warrants to Licensee the
following:
|
|
(a)
|
University
or Kentucky, as applicable, is the exclusive owner of, or with the
other
institution are the exclusive owners of, the Patent Rights.
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(b)
|
University
is authorized to execute, deliver and perform this Agreement (including,
without limitation, the granting of the licenses hereunder) on behalf
of
itself and Kentucky pursuant to the Inter Institutional Agreement
between
the University and Kentucky dated 15th
day of December, 2000 as amended on the 24th day of October, 2006,
and
neither such execution, delivery or performance is in violation of
any
license or obligation to which University is a party or is
bound;
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(c)
|
University
and Kentucky have not granted any other licenses, options or other
third-party rights to the Patent Rights in the Field, except as required
by the Xxxx-Xxxx Act and except for such licenses or options as have
been
terminated; and
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(d)
|
Neither
University's nor Kentucky’s Office of Technology Management has received
any actual notice claiming that (i) the Patent Rights infringe or
violate,
or have infringed or violated, the intellectual property or proprietary
rights of any third party; and/or (ii) the Patent Rights are invalid
or
unenforceable.
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ARTICLE
10 – ASSIGNMENT
|
10.1.
|
Licensee
may grant, transfer, convey, or otherwise assign any or all of its
rights
and obligations under this Agreement in conjunction with a Change
of
Control. University’s prior written consent 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 assignment in contravention of this Article 10
shall
be null and void.
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ARTICLE
11 – TERMINATION
|
11.1
|
University
shall have the right to terminate this Agreement
if:
|
|
(a)
|
Licensee
shall default in the performance of any material obligations herein
contained and such default has not been cured within sixty (60) days
after
receiving written notice thereof from University;
or
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|
(b)
|
Licensee
shall cease to carry out its business, become commence bankruptcy
proceedings, apply for or consent to the appointment of a trustee,
receiver or liquidator of its assets or seek relief under any law
for the
aid of debtors.
|
|
11.2
|
Licensee
may terminate this Agreement:
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|
11.3
|
upon
ninety day (90) prior written notice to University and upon payment
of all
amounts due University through the effective date of termination,
including patent cost reimbursement pursuant to Section 6.2
hereof.
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11.4
|
Upon
termination all rights and interest to the Licensed Technology and
Patent
Rights shall revert to University.
|
|
11.5
|
Upon
termination of this Agreement, neither party shall be released from
any
obligation that matured prior to the effective date of such termination.
Licensee and any sublicensee may, however, after the effective date
of
such termination, sell all products under the Licensed Technology
which
Licensee produced prior to the effective date of such termination,
provided that Licensee shall pay to University the royalties thereon
as
required by Article 4 hereof and submit the reports required by Article
5
hereof.
|
ARTICLE
12 – NOTICES
|
12.1
|
Any
notice or communication pursuant to this Agreement shall be sufficiently
made or given if sent by certified or registered mail, postage prepaid,
or
by overnight courier, with proof of delivery by receipt, addressed
to the
address below or as either party shall designate by written notice
to the
other party.
|
In
the
case of University:
Director
Office
of
Technology Management
University
of Pittsburgh
200
Xxxxxxx Steel Conference Center
Thackeray
& O’Hara Streets
Pittsburgh,
PA 15260
In
the
case of Licensee:
President
000
0xx
Xxxxxx,
00xx
Xxxxx
Xxx
Xxxx,
XX 00000
|
12.2
|
Any
payments to University hereunder by wire transfer shall be directed
as
follows:
|
Bank:
Xxxxxx Xxxx, XX, Xxxxxxxxxx, XX
ABA
Routing No.: [***]-University of Pittsburgh
Account
No.: [***]
Mellon
SWIFT Code: [***] (international transfers)
Reference
Code: Office of Technology Management
ARTICLE
13 – AMENDMENT, MODIFICATION
|
13.1
|
This
Agreement may not be amended or modified except by the execution
of a
written instrument signed by the parties
hereto.
|
ARTICLE
14 – MISCELLANEOUS
|
14.1
|
This
Agreement shall be construed and interpreted in accordance with the
laws
of the Commonwealth of Pennsylvania. The forum for any action relating
to
this Agreement shall be the Courts of Allegheny County, Pennsylvania,
or,
if in a federal proceeding, the United States District Court for
the
Western District of Pennsylvania.
|
|
14.2
|
The
parties acknowledge that this Agreement sets forth the entire
understanding and intentions of the parties hereto as to the subject
matter hereof and supersedes all previous understandings between
the
parties, written or oral, regarding such subject
matter.
|
|
14.3
|
Each
party shall obtain the prior written approval of the other prior
to making
use of the name of the other party for any commercial purpose, except
as
required to comply with law, regulation or court order. Neither party
shall issue any press release or make any public statement in regard
to
this Agreement without the prior written approval of the other
party.
|
|
14.4
|
If
one or more of the provisions of this Agreement shall be held invalid,
illegal or unenforceable, the remaining provisions shall not in any
way be
affected or impaired thereby. In the event any provision is held
illegal
or unenforceable, the parties shall use reasonable efforts to substitute
a
valid, legal and enforceable provision which, insofar as is practical,
implements purposes of the provision held invalid, illegal or
unenforceable.
|
|
14.5
|
Failure
at any time to require performance of any of the provisions herein
shall
not waive or diminish a party’s right thereafter to demand compliance
therewith or with any other provision. Waiver of any default shall
not
waive any other default. A party shall not be deemed to have waived
any
rights hereunder unless such waiver is in writing and signed by a
duly
authorized officer of the party making such
waiver.
|
|
14.6
|
Licensee
acknowledges that University is free to publish the results of the
research activities of its faculty, staff and students, even though
such
publication may involve the Patent Rights or Licensed Technology.
University agrees to submit to Licensee any proposed publication
or
presentation regarding the subject matter specifically described
in the
Patent Rights for prior review by Licensee at least thirty (30) days
before its submittal for publication or its presentation. Licensee
may,
within thirty (30) days after receipt of such proposed publication,
request that such proposed publication be delayed not more than sixty
(60)
days in order to allow for protection of intellectual property
rights.
|
IN
WITNESS WHEREOF, the parties have set their hands and seals as of the date
set
forth on the first page hereof.
|
UNIVERSITY
OF PITTSBURGH – OF THE
COMMONWEALTH
SYSTEM OF HIGHER
EDUCATION
|
|
|
By
|
/s/
Xxxxxx Xxxxxxx
|
|
Xxxxxx Xxxxxxx
|
|
|
Executive Vice
Xxxxxxxxxx
|
|
| XXXX THERAPEUTICS, INC. | |
|
By
|
/s/
Xxxxxx X. Xxxxx
|
|
Xxxxxx X. Xxxxx
|
|
|
Title:
|
President
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