EXCLUSIVE LICENSE AGREEMENT BETWEEN THE UNIVERSITY OF ARIZONA AND PROLX PHARMACEUTICALS CORPORATION
Exhibit
99.1
BETWEEN
THE
UNIVERSITY OF ARIZONA
AND
PROLX
PHARMACEUTICALS CORPORATION
Effective
as of 29 day of July, 2004 ("Effective Date"), the Arizona Board of Regents
on
behalf of the University of Arizona, having its principal offices in Xxxxxx,
Xxxxxxx 00000 (the "LICENSOR"), and PROLX PHARMACEUTICALS CORPORATION, having
a
principal place of business at 000 X. Xxxxx Xxxxxx, Xxxxxx, Xxxxxxx 00000
("LICENSEE"), agree as follows:
1. BACKGROUND
1.1 An
Interinstitutional Agreement, effective September 28, 2002, between and among
the Arizona Board of Regents on behalf of the University of Arizona, the
University of Pittsburgh of the Commonwealth System of Higher Education, and
The
Xxxxxxx Institute grants to the LICENSOR the right to administer and
commercialize through licensing the Technical Information and Licensed Patents,
as described in section 1.2 below.
1.2 The
LICENSOR wishes to exercise its right to administer and license valuable
intangible property rights in the technologies described in:
1.2.1 U.S.
Patent No. 5,378,725, issued January 3, 1995 as described in UA Xxxx
# 00-000 and entitled "Inhibition of phosphatidylinositol 3-kinase with
wortmannin and analogs thereof, assigned to the Arizona Board of Regents and
Xxx
Lilly and Company;
1.2.2 U.S.
Provisional Patent Application Serial Number 60/322,143, filed September 14,
2001, as described in UA Xxxx # 00-000 and entitled "Device and method for
treating restenosis;"
1.2.3 U.S.
Provisional Patent Application Serial Number 60/322,139, filed September 14,
2001, as described in UA Xxxx # 00-000 and entitled "Inhibition of
Phosphatidylinositol 3-kinase with wortmannin analogs;"
1.2.4 U.S.
Patent No. 6,703,414, issued March 9, 2004 as described in UA Case # 02-049
entitled "Device and Method for Treating Restenosis;"
1.2.5 PCT
Application No. US03/28920 filed September 15, 2003 as described in UA Case
#
02-049 entitled "Device and Method for Treating Restenosis;"
1.2.6 U.S.
Application Serial No. 10/245,779 filed September 16, 2002 as described in
UA
Xxxx # 00-000 and entitled "Wortmannin Analogs and Methods of Using
Same;"
1.2.7 PCT
Application No. US02/29635 filed September 16, 2002 as described in UA Xxxx
#
00-000 and entitled "Wortmannin Analogs and Methods of Using Same;"
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
1.2.8 EP
Application No. 02766286.5 filed September 16, 2002 as described in UA Xxxx
#
00-000 and entitled "Wortmannin Analogs and Methods of Using Same;"
1.2.9 Japan
Application No. 504100813 filed March 15, 2004 as described in UA Xxxx # 00-000
and entitled "Wortmannin Analogs and Methods of Using Same;"
1.2.10 Mexico
Application No. ____________ filed March 15, 2004 as described in UA Xxxx #
00-000 and entitled "Wortmannin Analogs and Methods of Using Same;"
1.2.11 Australia
Application No. 2002330029 filed September 16, 2002 as described in UA Xxxx
#
00-000 and entitled "Wortmannin Analogs and Methods of Using Same;"
and
1.2.12 Canada
Application No. ____________ filed March 12, 2004 as described in UA Xxxx #
00-000 and entitled "Wortmannin Analogs and Methods of Using Same;"
1.3 The
LICENSEE wishes to acquire an Exclusive license from LICENSOR for the purpose
of
undertaking development, to manufacture, use, import and sell products
incorporating said Technology and the LICENSOR is willing to grant such an
exclusive license in order to have the Technology developed into products and
marketed at the earliest possible time for use and benefit to the public and
the
LICENSOR.
2. DEFINITIONS
2.1 "Exclusive"
means that, subject to certain rights to the United States Government, LICENSOR
has not granted and shall not grant further licenses under the Licensed Patents
so long as this Agreement is in effect, and shall not make or have made Licensed
Products for use by third parties for commercial use nor sell or offer to sell
Licensed Products to third parties for commercial use.
2.2 "First
Commercial Sale"
means the first sale of a Licensed Product at an arms length transaction with
a
third party unaffiliated with any party to this Agreement.
2.3 "Licensed
Application(s)"
means the applications identified in Section 1.2 and any U.S. or foreign patent
applications and equivalents thereto that claim priority therefrom and claim
Technology, including any continuations, divisions, confirmations,
substitutions, registrations, revalidations, additions, extensions,
re-examination certificates, supplementary protection certificates and reissues
thereof, but excluding continuations-in-part, unless priority to such
applications or patents is perfected.
2.4 "Licensed
Patent(s)"
means the patents identified in Section 1.2 and any U.S. or foreign patents
issued or granted from the Licensed Applications and any and all existing or
future foreign counterparts of the patents listed in Section 1.2 or of patents
issued or granted from the Licensed Applications that claim priority therefrom
and claim Technology, including any continuations, divisions, confirmations,
substitutions, registrations, revalidations, additions, extensions,
re-examination certificates, supplementary protection certificates and reissues
thereof, but excluding continuations-in-part, unless priority to such
applications or patents is perfected.
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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2.5 "Licensed
Product(s)"
means any compound, product or part thereof, device, kit, method or service
for
which the manufacture, use, import or sale is covered by a valid claim of an
issued, unexpired Licensed Patent(s). A claim of an issued, unexpired Licensed
Patent(s) shall be presumed to be valid unless and until it has been held to
be
invalid by a final judgment of a court of competent jurisdiction from which
no
appeal can be or is taken.
2.6 "LICENSEE"
is understood to include ProlX Pharmaceuticals Corporation and any and all
of
its Affiliates. An Affiliate of LICENSEE shall mean any corporation or other
business entity controlled by, controlling, or under common control with
LICENSEE during the term of this Agreement. For this purpose, "control" means
direct or indirect beneficial ownership:
(a) of
at least fifty percent (50%) of the voting stock; or
(b) of
at least fifty percent (50%) interest in the income of such corporation or
other
business.
2.7 "Net
Sales"
means the gross invoice price generated by sale or use, including provision
of
service involving the use, of the Licensed Product(s) in the form in which
it is
sold or used, less the following items:
(a) Import,
export, excise, value added and sales taxes, plus custom duties;
(b) Costs
of insurance, packing and transportation from the place of manufacture to the
customer's premises or point of installation;
(c) Normal
and customary quantity and cash discounts; and
(d) Credit
for returns, allowances, or trades actually given.
For
Licensed Products sold or otherwise provided in combination with other products
or services, or provided in other than a sale transaction, Net Sales shall
be
based on the quantity of products or services provided times the price for
a
similar product or service when sold or otherwise provided separately by
LICENSEE in an arms-length transaction in similar quantities.
2.8 "Regulatory
Approval"
means any approval or clearance by any governmental agency or agencies having
authority to regulate the use or sale of any Licensed Product(s) in the
pertinent jurisdiction or territory.
2.9 "Technical
Information"
means the information in Licensed Application(s) and Licensed Patents as well
as
any technical data and material necessary to enable LICENSOR to make, have
made,
use, sell, have sold, offer for sale, import, and otherwise obtain or provide
Licensed Product or technical data or material provided to LICENSEE by LICENSOR
or its employees or contractors including, without limitation, any biochemical,
preclinical, clinical, manufacturing, formulation, and scientific research
information of a confidential nature whether patentable or unpatentable,
relating to, but limited to the general subject matter described or claimed
in,
the Licensed Application(s) and/or Licensed Patent(s).
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
-3-
2.10 "Technology"
means the technology described in the patents and applications identified in
Section 1.2.
2.11 "Verifiable
Research Costs"
means any costs of research and development of Licensed Product, but excluding
costs that are paid for or reimbursed by research grants, contracts with third
parties, or other non-contractual agreements.
2.12 "LICENSOR(S)"
means the Arizona Board of Regents on behalf of the University of Arizona,
which
represents the University of Pittsburgh of the Commonwealth System of Higher
Education and The Xxxxxxx Institute as set forth in Sec. 1.1 above.
3. GRANT
3.1 LICENSOR
hereby grants under LICENSOR’s valuable intangible property rights and subject
to the terms of this Agreement, and LICENSEE hereby accepts, an Exclusive
worldwide license to make, have made, use, sell, have sold, offer for sale,
import, and otherwise obtain or provide Licensed Product(s) and a non-exclusive
worldwide license to use Technical Information. For the avoidance of doubt,
nothing in the preceding grant shall be interpreted as limiting retained rights
of the University of Arizona, the University of Pittsburgh of the Commonwealth
System of Higher Education or The Xxxxxxx Institute to use Licensed Patents
for
educational and research purposes.
3.2 LICENSOR
grants LICENSEE the right to grant sublicenses to third parties, so long as
the
grant to any sublicensee is within the scope of the grant of Article 3.1 to
LICENSEE and as long as LICENSEE possesses an Exclusive License under this
Agreement. Any and all sublicense agreements granted by LICENSEE shall also
include all of the rights and obligations due under this Agreement by LICENSEE
to LICENSOR and, if applicable, the United States government. These rights
due
LICENSOR in all sublicenses include, but are not limited to, the right of
LICENSOR to receive all royalties and fees under Articles 4 and 5.
LICENSEE shall notify the LICENSOR of each sublicense granted hereunder and
provide LICENSOR with a copy of each sublicense. LICENSEE shall collect and
pay
all fees and royalties due LICENSOR and guarantee all such payments due from
sublicensees. LICENSEE shall require sublicensees to provide payments with
royalty reports, and LICENSEE shall collect and summarize for LICENSOR all
such
reports due from sublicensees. LICENSEE shall monitor sublicensees and assure
license terms are met and product quality is equal to or greater than that
required by this Agreement. Upon termination of this Agreement for any reason,
LICENSOR, at its sole discretion, shall determine whether any or all sublicenses
shall be canceled or assigned to LICENSOR.
4. FEES,
ROYALTIES, PAYMENTS AND MILESTONES
4.1 LICENSEE
agrees to pay an upfront License Fee of [+] One half of the payment is due
within fourteen (14) days of the Effective Date; the balance is due six (6)
months after the Effective Date.
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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4.2 LICENSEE
agrees to cover the costs incurred in connection with the preparation, filing
and prosecution of the Licensed Applications and the maintenance of Licensed
Patents. After the effective date, and during the term of this Agreement,
LICENSEE agrees to assume responsibility for future patent prosecution and
maintenance costs as provided in the following Article 7.1.
4.3 LICENSEE
shall pay to LICENSOR milestone royalties relating to Regulatory Approval for
Licensed Product as follows:
(1) [+]
(2) [+]
(3) [+]
(4) [+]
LICENSEE
may investigate more than one Licensed Product through Phase II tests without
paying more than one set of milestone royalties. If LICENSEE should choose
to
submit multiple NDAs covering the same Licensed Product or an NDA covering
more
than one Licensed Product, then the milestone royalties relating to additional
Licensed Products are as set forth in 4.2 (3) and (4) above being reduced by
[+]
of the first amount due. If, after obtaining Regulatory Approval for an NDA
or
its equivalent, LICENSEE attempts to develop additional Licensed Products,
milestone royalties relating to such products will be reduced by
[+].
4.4 In
addition, LICENSEE shall pay LICENSOR earned royalties on Net Sales of Licensed
Product sold directly by LICENSEE in the country in which the Licensed Product
is made, used or sold. [+]
4.5 LICENSEE
shall pay to LICENSOR [+].
4.6 The
royalty on sales in currencies other than U.S. Dollars shall be calculated
using
the appropriate foreign exchange rate for such currency quoted by the Wall
Street Journal, on the close of business on the last banking day of each
calendar quarter. Royalty payments to LICENSOR shall be in U.S.
Dollars.
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
-5-
5. REPORTS,
PAYMENTS AND ACCOUNTING
5.1 Quarterly
Royalty Payment and Report.
LICENSEE shall make written reports and royalty payments to LICENSOR within
ninety (90) days after the end of each calendar quarter following the First
Commercial Sale ("Quarterly Report"). This Quarterly Report shall state the
number, description, and aggregate Net Sales of Licensed Product(s) during
such
completed calendar quarter, and resulting calculation of earned royalty payment
due the LICENSOR for such completed calendar quarter. Concurrent with the making
of each such report, LICENSEE shall include payment due LICENSOR of royalties
for the calendar quarter covered by such report.
All
Payments pursuant to the License shall be made and sent to the following
address:
Director
Office
of Technology Transfer
The
University of Arizona
X.X.
Xxx 000000
Xxxxxx,
XX 00000-0000
5.2 Annual
Progress Reports.
LICENSEE shall provide to LICENSOR annual written progress reports with the
first Quarterly Report for each calendar year after the Effective Date of this
agreement. The reports shall include sufficient detail to allow LICENSOR to
determine progress on research and development, manufacturing, sublicensing,
marketing and sales during the previous twelve (12) months as well as plans
for
the coming year.
5.3 Accounting.
LICENSEE agrees to keep records for a period of seven (7) years showing the
manufacturing, sales, use, and other disposition of products sold or otherwise
disposed of under the license herein granted in sufficient detail to enable
the
royalties payable hereunder by LICENSEE to be determined, and further agrees
to
permit its books and records to be examined from time to time by a certified
public accountant of a nationally recognized accounting firm (the "Auditor"),
who is selected and paid for by LICENSOR, but no more than once per calendar
year to the extent necessary to verify reports provided for in Paragraph 5.1.
The information obtained shall be treated as a Confidential Item pursuant to
Article 9.
5.4 If
the Auditor determines that LICENSEE has, for any reason, failed to pay the
full
royalties as due under this Agreement, the Auditor shall inform LICENSOR and
LICENSEE. LICENSEE shall immediately upon notice thereof pay to LICENSOR any
owed royalties plus interest at the rate of [+] per annum above the average
prime rate for that calendar year, compounded daily, calculated from the date
upon which such royalties should have been paid to the date of actual payment
of
LICENSOR. If the Auditor determines that LICENSEE has overpaid royalties due
under this Agreement, such overpayments shall be credited against future
royalties due LICENSOR. In the event that underpayments of royalties due exceed
[+] then the cost of the next two examinations of LICENSEE’s books and records
shall be borne by LICENSEE.
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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6. REPRESENTATIONS
6.1 LICENSOR
represents that it has the right to grant LICENSEE the license granted herein
and that it has not granted any license to the Licensed Patents or Licensed
Applications or any rights in any Licensed Product(s) to any third party, except
for United States government rights which may have been required by
law.
6.2 LICENSOR
represents that, to LICENSOR’s knowledge, information and belief at the time of
execution of this Agreement:
(a) there
are no other patents, applications, or invention disclosures naming one or
more
of the inventors of Licensed Applications or Licensed Patents owned or assigned
to LICENSOR which dominate or are dominated by the claimed subject matter of
Licensed Patents; and
(b) other
than the LICENSOR, there are no co-owners of the Licensed Applications and
Licensed Patents, except as set forth herein.
6.3 LICENSEE
represents to LICENSOR that LICENSEE shall diligently perform all of its
obligations under the Agreement.
6.4 EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR
PENDING.
6.5 EXCEPT
FOR ITS OBLIGATIONS OF COOPERATION AS SET FORTH IN SECTION 8 HEREOF, NOTHING
IN
THIS AGREEMENT, EITHER EXPRESS OR IMPLIED, OBLIGATES LICENSOR EITHER TO BRING
OR
PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR PATENT INFRINGEMENT OR
TO
FURNISH ANY KNOW-HOW OR TRADE SECRETS NOT PROVIDED IN LICENSOR'S PATENT
RIGHTS.
6.6 IN
NO EVENT SHALL LICENSOR BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES RESULTING FROM THE EXERCISE OF THIS LICENSE OR THE USE OF THE TECHNICAL
INFORMATION OR LICENSED PRODUCTS.
6.7 NO
WARRANTY OR REPRESENTATION IS MADE THAT ANYTHING MADE, USED, OR SOLD UNDER
THE
TERMS OF THIS AGREEMENT WILL BE FREE FROM INFRINGEMENT OF ANY THIRD PARTY
PATENTS.
6.8 THIS
AGREEMENT DOES NOT CONFER BY IMPLICATION, ESTOPPEL, OR OTHERWISE ANY LICENSE
OR
RIGHTS TO ANY OTHER PATENT OF LICENSOR OTHER THAN PATENT RIGHTS AS EXPRESSLY
STATED HEREIN, REGARDLESS OF WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE
TO
PATENT RIGHTS.
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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7. PROSECUTION
OF LICENSED PATENTS
7.1.1 LICENSEE
agrees to accept liaison and financial responsibilities, as hereinafter set
forth, for the prosecution, by a patent lawyer in independent practice, who
shall be nominated by LICENSEE and approved by LICENSOR, of the Licensed
Applications listed in Section 1.2, and additional applications as the parties
may subsequently agree. Said financial responsibilities shall not only include
the costs of prosecution but also the payment of maintenance fees, where
required, to maintain said patent applications and patents, if issued, in force
and effect for as long as possible. It is further agreed that the patent lawyer
selected and paid by LICENSEE and approved by LICENSOR shall be required, if
so
desired by LICENSOR, to keep LICENSOR informed of all steps in the prosecution
and maintenance of said Licensed Applications and Licensed Patents. Notice
of
prosecution and maintenance of said Licensed Applications and Licensed Patents
shall be sent by express courier delivery to:
Internal
IP Counsel
Office
of Technology Transfer
The
University of Arizona
000
X. Xxxxxx Xxxxxx, Xxxx 000
Xxxxxx,
XX 00000-0000
If,
for any reason, prosecution or maintenance of a particular patent application
or
patent in a particular country is to be abandoned by LICENSEE, LICENSOR will
be
notified in sufficient time to assume prosecution should LICENSOR desire to
do
so. LICENSEE shall bear all cost to maintain the patent prosecution until such
time that LICENSOR can assume patent prosecution. LICENSEE, by abandonment
of
any particular patent application or patent, terminates its rights under Article
3 in said patent application or patent and said patent application or patent
shall no longer be considered part of Licensed Applications or Licensed Patents
for purposes of this Agreement or any sublicense derived herefrom.
Within
two (2) weeks of notification to LICENSOR by LICENSEE, LICENSEE or its current
patent counsel will furnish complete file histories and a summary of current
actions required of all of the patent applications constituting said Licensed
Applications to the patent lawyer nominated by LICENSOR to continue prosecution
of patents abandoned by LICENSEE.
7.2 LICENSOR
shall have the right at any time, by notice in writing and sent to LICENSEE
by
registered mail, to assume and continue at its own expense, direction of the
prosecution of any of said Licensed Applications. Upon receipt by LICENSEE
of
any such notice from LICENSOR, LICENSEE and the patent lawyer nominated in
accordance herewith shall provide in two (2) weeks from the time of notice
an
executed power of attorney and the file history of the patent application
constituting said Licensed Applications to which notice is directed. Upon
receipt of this documentation, LICENSEE and the patent attorney nominated by
LICENSEE shall be
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
-8-
relieved
of all future responsibilities to prosecute the Licensed Applications to which
the notice is directed. In which event, LICENSOR agrees to use its good faith
efforts to apply for, seek prompt issuance of, and maintain during the term
of
this Agreement, Licensed Patents to the extent necessary to cover both broadly
and specifically Licensed Products. LICENSEE shall have reasonable opportunity
to advise LICENSOR and shall cooperate with LICENSOR in such filing, prosecution
and maintenance. LICENSOR shall use its good faith efforts to furnish LICENSEE
with copies of any patent application sufficiently in advance of its anticipated
filing date to give LICENSEE a reasonable opportunity to review and comment
thereon. In this event, LICENSOR also agrees to furnish LICENSEE with copies
of
all substantive communications to and from U.S. and foreign patent offices
regarding Licensed Applications and in good faith shall consider the reasonable
comments of LICENSEE regarding all communications and filings to and from the
respective patent office.
7.3 [+]
8. INFRINGEMENT
8.1 LICENSOR
and LICENSEE shall promptly give notice to the other in writing of any alleged
infringement of Licensed Patents and of any other legal action undertaken by
either party with respect to the defense or enforcement of Licensed Patents.
The
parties shall thereupon confer as to what steps are to be taken to stop or
prevent such infringement.
8.2 LICENSEE
shall have the first right to defend or enforce Licensed Patents against any
infringer at LICENSEE’s cost and expense including by bringing any legal action
for infringement or defending any counterclaim of invalidity or action of a
third party for declaratory judgment of non-infringement, which LICENSEE, in
its
sole discretion, decides is reasonable and necessary for it to undertake.
LICENSEE shall bring or defend or may settle any such actions solely at its
own
discretion and expense and through counsel of its selection. LICENSEE will
be
entitled to retain any settlement or damage award received except as provided
for in Article 8.4; provided, however, that each LICENSOR shall be entitled
in
each instance to participate through counsel of its own selection and its own
expense and share in any damage award or settlement as mutually agreed upon
in
writing by the parties prior to such participation. LICENSEE shall not join
LICENSOR as a party-plaintiff in any suit which LICENSEE may institute unless
necessary for the maintenance of said suit, and then only with the prior
knowledge and written consent of LICENSOR, which consent shall not be
unreasonably withheld. In such event that LICENSOR is an unwilling participant
in any suit which LICENSEE may institute, LICENSOR shall not be chargeable
for
any costs or expenses and those costs and expenses shall be borne by LICENSEE.
LICENSOR shall execute all documents necessary for the prosecution of any
infringement suit brought by LICENSEE and provide other such support as LICENSEE
may require including having its employees testify when requested and make
available relevant records, papers, information, samples, specimens and the
like, all however at the expense, with respect to travel and the like, of
LICENSEE.
8.3 LICENSOR
shall have the right to defend or enforce the Licensed Patents against
infringement in the event that LICENSEE declines to exercise its rights to
defend or enforce Licensed Patents under Article 8.2 and shall have sole
discretion to file and prosecute, defend or
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
-9-
settle
such infringement and declaratory judgment action at its own expense through
counsel of its own selection and will be entitled to retain any settlement
or
damage award received; provided, however, that LICENSEE shall be entitled in
each instance to participate through counsel of its own selection and at its
own
expense. LICENSEE shall have no responsibility or financial obligation with
respect to any such infringement action except to provide reasonable assistance
to LICENSOR as requested and LICENSOR shall reimburse LICENSEE for LICENSEE’s
out-of-pocket expenses in connection with any such assistance. LICENSEE shall
execute all documents necessary for the prosecution of any infringement suit
brought by LICENSOR and provide other such support as LICENSOR may require,
including having its employees testify when requested and make available
relevant records, papers, information, samples, specimens and the like, all
however at the expense, with respect to travel and the like, of LICENSOR.
8.4 LICENSOR
shall be entitled to the percentage of any recovery obtained in any infringement
suit brought by LICENSEE equal to the amount to which LICENSOR would be entitled
under the sublicensee royalty provision of this Agreement had said recovery
been
paid to LICENSEE as sublicense royalties by the defendant in said infringement
suit. LICENSEE may deduct its reasonable direct costs and attorneys' fees paid
to third parties incurred in prosecuting such suit; to the extent such costs
and
fees are not otherwise recovered, prior to calculating the share owing to
LICENSOR pursuant to this provision.
8.5 Should
LICENSEE commence a suit under the provisions of Paragraphs 8.2 and thereafter
elect to abandon the same, it shall give timely notice to LICENSOR, which may,
if it so desires, continue prosecution of such suit under Article
8.3.
8.6 During
the period of this Agreement, if LICENSOR’s actions under Article 8.3 require a
sublicense to an infringer, LICENSEE shall grant such a sublicense to said
infringer in accordance with the terms and conditions herein and the terms
and
conditions of any settlement or other judgment effected by LICENSOR. LICENSEE
shall receive such royalties under any such sublicense and LICENSOR shall be
entitled to royalties therefrom as specified in Paragraph 4.3.
9. PUBLICITY
AND CONFIDENTIALITY
9.1 Neither
party shall use the name of the other in any form of advertising or promotion
without the prior written approval of the other, except to announce this
Agreement.
9.2 Confidential
Items.
Confidential Items shall mean any proprietary information or materials belonging
to the disclosing party, in writing, clearly marked CONFIDENTIAL (whether or
not
patentable) including, but not limited to, patent filings; descriptions of
formulations, techniques, know-how, methodology; data, reports, information
regarding sources of supply or patent positioning; consultant(s)'s reports
and
business plans, including any negative developments, which are communicated
to,
learned by, or otherwise acquired by the party receiving such information or
materials during or in the course of this Agreement; and further including
information concerning the existence, scope or activities of any research and
development project of the disclosing party.
9.3 Each
party shall hold in confidence for a period of five (5) years, and shall not
disclose to any person outside its respective organization, any Confidential
Items disclosed to it by
[+]
DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
-10-
the
other party to this Agreement. The party receiving such Confidential Items
shall
use such Confidential Items only for the limited purpose for which it was
disclosed and shall not exploit such Confidential Items for its own benefit
or
the benefit of another without the prior written consent of the disclosing
party. Each party shall disclose Confidential Items of the other party under
this Agreement only to persons within its organization and to consultants who
have a need to know such Confidential Items in the course of the performance
of
their duties and who are bound to protect the confidentiality of such
Confidential Items.
9.4 The
confidentiality and non-use obligations of the receiving party shall not apply
to any Confidential Item(s) which is received by one party from the other party
and which:
(i) is
disclosed in a printed publication available to the public, is described in
an
issued patent anywhere in the world, is otherwise in the public domain at the
time of disclosure, or becomes publicly known through no breach of this
Agreement by the receiving party;
(ii) becomes
known to the receiving party through disclosure by sources other than the
disclosing party having the right to disclose such Confidential
Items;
(iii) is
disclosed pursuant to the requirements of a governmental agency or any law
requiring disclosure thereof, provided that the disclosing party is provided
with prior written notice of any such disclosure;
(iv) is
generally disclosed to third parties by the disclosing party without similar
restrictions on such third parties;
(v) is
approved for release by written authorization of an officer of the disclosing
party;
(vi)
is already known by the receiving party as evidenced by its prior written
records; or
(vii) is
developed by receiving party independently of and without reference to
Confidential Items received from disclosing party as evidenced by written
record.
provided,
however, that a breach of the foregoing obligations shall not be absolved by
the
subsequent occurrence of any of the above exceptions.
10. PUBLICATION
10.1 Subject
to all other terms of this Agreement, including those concerning
confidentiality, investigators at the University of Arizona, the University
of
Pittsburgh of the Commonwealth System of Higher Education and The Xxxxxxx
Institute have the right to publish or otherwise publicly disclose information.
However, the aforementioned investigators will provide LICENSEE with copies
of
articles reporting on research involving the Licensed Patents as soon as
practicable but in no event later than simultaneously with their submission
for
publication to a peer-reviewed publication and will timely provide an outline
of
any other public disclosure in order to provide LICENSEE an opportunity to
determine if LICENSEE Confidential Items will be disclosed.
11. DUE
DILIGENCE
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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11.1 LICENSEE
shall use good faith efforts to develop, obtain clinical approval for,
manufacture, market and promote Licensed Products.
[+]
12. TERM
AND TERMINATION
12.1 Term
of License.
(a) The
Term of this Agreement shall be for a period beginning with the Effective Date
and extending until the last to expire valid claim of a Licensed Patent, unless
sooner terminated as herein provided. Surviving any termination are: (a)
LICENSEE’s obligation to pay royalties accrued or accruable for sell-off of
inventory pursuant to Paragraph 12.1(d); and (b) any cause of action or claim
of
LICENSEE or LICENSOR, accrued or to accrue, because of any breach or default
by
the other party.
(b) Subject
to the provisions of Section 11.3 hereof, which describes the only method by
which LICENSOR shall be entitled to terminate this Agreement on the basis of
failure to use appropriate diligence, upon any material breach or default under
this Agreement by LICENSEE, LICENSOR may give written notice thereof to
LICENSEE, and LICENSEE shall have sixty (60) days thereafter to cure such breach
or default. If such breach or default is not so cured, LICENSOR may then in
its
sole discretion and option (a) terminate this Agreement and the licenses granted
herein or (b) seek such other relief as may be provided by law in such
circumstances by giving written notice thereof to LICENSEE. Repetitive breaching
of this Agreement by LICENSEE also shall be considered a material breach of
this
Agreement for which LICENSOR may declare, at its sole discretion, that either
no
cure possible and terminate this Agreement and the licenses granted herein
or
seek an amendment to this Agreement as a requirement for any cure of the
repetitive breaching.
(c) LICENSEE
shall have the right to terminate this Agreement at any time upon ninety (90)
days written notice to LICENSOR and payment of all amounts due LICENSOR through
the effective date of termination.
(d) Upon
termination of this Agreement under any provision, all further obligations
of
the parties under this Agreement shall terminate without further liability
of
any party to another; provided, however, that the publicity and confidentiality
obligations of the parties contained in Article 9 hereof, shall survive any
such
termination for the periods set forth therein. Termination shall not relieve
any
party of any obligation occurring prior to such termination, of any liability
for a breach of, or for any misrepresentation under this Agreement or be deemed
to constitute a waiver of any available remedy (including specific performance
if available) for any such breach or misrepresentation, provided, however,
that
neither party shall be liable for consequential, punitive or special damages
including without limitation, lost profits. Except for legal actions that may
prohibit such activity, LICENSEE and any sublicensee thereof may, for six months
after the effective date of such termination, sell all Licensed Products, and
complete Licensed Products in the process of manufacture and fulfill all orders
for Licensed Products at the time of such termination and sell the same,
provided that LICENSEE shall pay to LICENSOR the
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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royalties
thereon as required by Article 4 of this Agreement and shall submit the reports
required by Article 5 hereof on the sales of such Licensed
Products.
(e) In
the event of termination of this Agreement for any reason, any and all rights
granted LICENSEE hereunder, including any rights granted by LICENSEE to any
sublicensee, shall cease and terminate, and all such rights shall revert to
LICENSOR. LICENSEE shall diligently thereafter return to LICENSOR, or to
LICENSOR’s designated attorneys, any files or other documents in its possession
or in the possession of its attorneys, agents or sublicensees, relating to
pending or issued Licensed Patent(s), except that one copy of each such document
may be retained by LICENSEE’s attorney for the purpose of ensuring compliance
hereunder. LICENSEE shall also execute any and all documents necessary to return
control of said Licensed Patent(s) until such time as control has properly
been
transferred to LICENSOR. Further, LICENSEE shall immediately return to LICENSOR
all research data, biological and other material (including but not limited
to
licensed cell lines), prototypes, process information, clinical data and the
like of LICENSOR in its possession or in the possession of its
sublicensees.
13. ASSIGNMENT
13.1 This
Agreement shall not be assignable by either party without the prior written
consent of the other party, such consent not to be unreasonably withheld.
Notwithstanding however, LICENSEE may assign this Agreement to an entity, which
acquires all or substantially all of the assets to which this Agreement pertains
without the prior consent of LICENSOR. [+]
14. INDEMNIFICATION
14.1 LICENSEE
agrees that during the term of this Agreement and thereafter, it will indemnify,
defend and hold the University of Arizona, the University of Pittsburgh of
the
Commonwealth System of Higher Education, and the Xxxxxxx Institute, and their
trustees, officers, employees and affiliates, harmless against all claims and
expenses, including legal expenses and attorneys' fees, arising out of the
death
of or injury to any person or persons, or out of any damage to property, and
against any other claim, proceeding, demand, expense and liability of any kind
whatsoever resulting from the production, manufacture, sales, use, consumption,
disposal or advertisement of Licensed Products by LICENSEE.
14.2 LICENSEE,
at its sole cost and expense, shall insure its activities in connection with
the
work under this Agreement and obtain, keep in force, and maintain insurance
as
follows, or an equivalent program of self insurance:
(a) Comprehensive
or commercial general liability insurance (contractual liability included)
with
its minimum limits as follows:
Each
Occurrence $1,000,000
Products/Completed
Operations Aggregate $5,000,000
Personal
and Advertising Injury $1,000,000
General
Aggregate (commercial form only) $5,000,000
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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(b) The
coverage and limits specified above do not in any way limit the liability of
the
LICENSEE under this Agreement. The LICENSEE shall furnish LICENSOR with
certificates of insurance showing compliance with all requirements. Such
certificates must:
Provide
for thirty (30) day advance written notice to LICENSOR of any
modification.
Indicate
that LICENSOR has been endorsed as an additional Insured under the coverage
specified above.
Include
a provision that the coverage will be primary and will not relate to nor will
be
excess over any valid and collectable insurance or program of self-insurance
carried or maintained by LICENSOR.
14.3 LICENSOR
shall notify LICENSEE in writing of any claim or suit brought against LICENSOR
in respect of which LICENSOR intends to invoke the provisions of this Article.
LICENSEE shall keep LICENSOR informed on a current basis of its defense of
any
claims under this Article.
15. NOTICES
15.1 All
notices under this Agreement not otherwise set forth for specific delivery
shall
be deemed to have been fully given when done in writing and deposited in the
United States mail, registered, certified or express, and addressed, or when
actually received, as follows:
| TO LICENSOR: | Director |
|
Office
of Technology Transfer
|
|
|
The
University of Arizona
|
|
|
000
X. Xxxxxx Xxx., Xxxxx 000
|
|
|
Xxxxxx,
XX 00000-0000
|
|
| TO LICENSEE: | Xx. Xxxx Xxxxxxxxxxx |
|
CEO
|
|
| Pro1X Pharmaceuticals Corporation | |
|
000
X. 0xx Xxxxxx
|
|
|
Xxxxxx,
XX 00000
|
Either
party may change its address upon notice to the other party as provided
herein.
16. GENERAL
PROVISIONS
16.1 Equal
Opportunity.
The parties agree to be bound by applicable state and federal rules governing
equal employment opportunity and nondiscrimination.
16.2 State
Funding.
The parties recognize that the performance of the LICENSOR may be dependent
upon
the appropriation of funds by the Arizona State Legislature. Should the
Legislature
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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of
Arizona fail to appropriate the necessary funds, LICENSOR may cancel this
Agreement without further duty or obligation. The LICENSOR agrees to notify
the
LICENSEE as soon as reasonably possible after the unavailability of said funds
comes to the LICENSOR’s attention.
16.3 Arbitration.
The parties agree that should a dispute arise between them, in any manner,
concerning this Agreement, and said dispute involves the sum of Thirty Thousand
Dollars ($30,000) or less in money damages only, exclusive of interest or cost
of attorney's fees, the parties will submit the matter to binding arbitration
pursuant to the Arizona Supreme Court Rules for Compulsory Arbitration and
the
decision of the arbitrator(s) shall be final and binding upon the
parties.
16.4 Conflict
of Interest.
This Agreement is subject to the provisions of A.R.S. § 38-511(E) and conflict
of interest laws of the State of Arizona. Either party may cancel this Agreement
by written notice to other party if any person substantially involved in
obtaining, drafting, or procuring this Agreement for or on behalf of a party
becomes an employee or consultant in any capacity of the other
party.
16.5 Waiver.
None of the terms, covenants and conditions of this Agreement can be waived
except by the written consent of the party waiving compliance.
16.6 Severability.
The provisions of this Agreement shall be deemed severable, and the invalidity
or unenforceability of any provision shall not affect the validity and
enforceability of the other provisions hereof.
16.7 Headings.
The description headings in this Agreement are inserted for convenience only
and
do not constitute a part of this Agreement.
16.8 Execution
in Counterpart.
This Agreement may be executed in any number of counterparts, each of whom
shall
be deemed an original.
16.9 Entire
Agreement.
This writing constitutes the entire agreement of the parties and there are
no
promises, understandings or agreements of any kind pertaining to this Agreement
other than those written in this Agreement. This Agreement supercedes all
previous Agreements in this matter.
16.10 Governing
Law. This Agreement and the rights of the parties hereunder shall be governed
by
and construed in accordance with the laws of the State of Arizona exclusive
of
choice of law rules.
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
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IN
WITNESS WHEREOF,
the parties thereto have executed this Agreement in duplicate originals by
their
duly authorized officers or representatives.
| ARIZONA BOARD OF REGENTS | PROLX PHARMACEUTICALS | |||
|
On
behalf of
|
||||
| THE UNIVERSITY OF ARIZONA | ||||
| By: | /s/ Xxxxxxx X. Xxxxx | By: | /s/ D. Xxxx Xxxxxxxxxxx | |
| Name: Xxxxxxx X. Xxxxx, Ph.D., M.B.A. | Name: D. Xxxx Xxxxxxxxxxx, Ph.D. | |||
| Title: Director, Office of Technology Transfer |
Title:
CEO
|
|||
| Date: | 7/23/04 | Date: |
7/29/04
|
|
|
University
of Arizona Inventor Acknowledgement of Terms and
Conditions
|
| /s/ Xxxxx Xxxxx | Date: | 05/21/05 | |||
|
Xxxxx
Xxxxx, Ph.D.
|
|||||
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DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSES.
