EXCLUSIVE LICENSE AND SUBLICENSE AGREEMENT by and between VISTAGEN THERAPEUTICS, INC. and APOLLO BIOLOGICS LP EXCLUSIVE LICENSE AND SUBLICENSE AGREEMENT
Exhibit 10.1
EXCLUSIVE
LICENSE AND SUBLICENSE AGREEMENT
by and
between
and
APOLLO
BIOLOGICS LP
-1-
EXCLUSIVE
LICENSE AND SUBLICENSE AGREEMENT
This
Agreement is effective as of December 9, 2016
(the “Effective
Date”), by and between VistaGen Therapeutics, Inc., a
California corporation located at 000 Xxxxxxxx Xxxxxx, Xxxxx Xxx
Xxxxxxxxx, XX 00000 (“VistaGen”), and Apollo
Biologics LP, a Delaware limited partnership located at c/o Versant
Venture Management, LLC, Xxx Xxxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, XX
00000 (“Apollo”). VistaGen and
Apollo are each sometimes referred to herein as
a “Party” or collectively as
the “Parties.”
RECITALS
WHEREAS, VistaGen
and University Health Network (“UHN”) entered into that
certain (i) License Agreement, dated as of October 24, 2011, a copy
of which is attached hereto as Schedule A (“License Agreement Number
One”), (ii) License Agreement, dated as of December
22, 2014, a copy of which is attached hereto as Schedule B (“License Agreement Number
Two”), (iii) License Agreement, dated as of December
9, 2016, a copy of which is attached hereto as Schedule C (“License Agreement Number
Three”) and (iv) License Agreement, dated as of
December 9, 2016, a copy of which is attached hereto as
Schedule D
(“License Agreement
Number Four” and together with License Agreement
Number One, License Agreement Number Two, License Agreement Number
Three and any additional license agreement entered into between UHN
and VistaGen in accordance with Section 2.5 below, each a “License Agreement” and
collectively, the “License
Agreements”);
WHEREAS, VistaGen
and UHN have entered into that certain Patent License Amendment
Agreement, dated as of December 9, 2016, pursuant to which each
License Agreement is amended;
WHEREAS, pursuant
to each License Agreement, VistaGen is the exclusive licensee, with
the right to grant sublicenses (through multiple tiers), of all
right, title and interest in the Licensed IP, subject only to a
royalty-free, nonexclusive, non-transferable license to practice
the Licensed IP granted by UHN to the United States Government for
governmental purposes;
WHEREAS, Apollo
desires to obtain, and VistaGen is willing to grant, (i) an
exclusive sublicense under the Licensed IP in the Apollo Field of
Use in accordance with each License Agreement, (ii) an exclusive
license under the Present Improvements in the Apollo Field of Use
under the terms of this Agreement and (iii) a non-exclusive license
under the Future Improvements in the Apollo Field of Use, in each
case of (i)-(iii), under the terms of this Agreement;
and
WHEREAS, prior to
entering into this Agreement, VistaGen has delivered sufficient
evidence reasonably satisfactory to Apollo that (i) the Sponsored
Research Collaboration Agreement by and between UHN and VistaGen,
dated as of September 18, 2007, as amended from time to time (the
“VistaGen
SRA”) has been terminated and (ii) the Strategic
Consulting Agreement by and between VistaGen and Xxxxxx Xxxxxx,
Ph.D., dated as of August 1, 2014 has been appropriately amended to
allow Xx. Xxxxxx to enter into a new consulting agreement with
Apollo.
NOW,
THEREFORE, in consideration of the promises and mutual covenants
herein contained and for other good and valuable consideration, the
adequacy and receipt of which are hereby acknowledged, VistaGen and
Apollo hereby agree as follows:
___________________
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
ARTICLE 1
1.1 “Affiliate”
shall mean any entity which directly or indirectly controls, or is
controlled by, or is under common control with, a Party. The term
“control” as used herein means (a) in the case of
corporate entities, direct or indirect ownership of at least fifty
percent (50%) of the stock or shares entitled to vote for the
election of directors; or (b) with the power to direct the
management and policies of such entities.
1.2 “Apollo
Field of Use” shall mean [*****] cardiac cell therapy [*****], including for use in human
medical or veterinary purposes [*****].
1.3 “Bankruptcy
Code” means Title 7 or Title 11 U.S. Code, or any
similar federal, state (or with respect to Canada, provincial) or
foreign law for the relief of debtors.
1.4
“Biosimilar Product” shall
mean, with respect to a Licensed Product and on a
country-by-country basis, a product that (i) is marketed for sale
in such country by a third party (not licensed, supplied or
otherwise permitted by a Party or its Affiliates or Sublicensees);
(ii) contains the corresponding Licensed Product or substantial
equivalent as an active pharmaceutical ingredient in such country;
and (iii) such product, as and to the extent required, is approved
through an abbreviated process (similar, with respect to the United
States, to an Abbreviated New Drug Applications under Section
505(j) of the FD&C Act (21 USC 355(j)) or is approved as a
“Biosimilar Biologic Product” under Title VII, Subtitle
A Biologics Price Competition and Innovation Act of 2009, Section
42 U.S.C. 262, Section 351 of the PHSA, or, outside the United
States, in accordance with European Directive 2001/83/EC on the
Community Code for medicinal products (Article 10(4) and Section 4,
Part II of Annex I) and European Regulation EEC/2309/93
establishing the Community procedures for the authorization and
evaluation of medicinal products, each as amended, and together
with all associated guidance, and any counterparts thereof or
equivalent process inside or outside of the United States or
European Union to the foregoing.
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
1.5 “Calendar
Year” means each successive period of twelve (12)
months commencing on January 1 and ending on December
31.
1.6 “Combination
Product” shall mean any Revenue Bearing Product sold
or used in combination with one or more other products or
components which are not Revenue Bearing Products.
1.7 “FDA”
means the United States Food and Drug Administration or its
successor.
1.8 “Field
of Use” shall mean the Apollo Field of Use or the
VistaGen Field of Use, as applicable.
1.9 “First
Commercial Sale” shall mean, with respect to a
Licensed Product and a country, the first sale to an independent
third party in such country after all Regulatory Approvals,
including any pricing or reimbursement approvals, as applicable,
have been obtained in such country.
1.10 “Future
Improvement” shall mean an Improvement created,
conceived or reduced to practice after the Effective
Date.
1.11 “Future
Improvement Patent Rights” shall mean the patent
rights within any Future Improvements.
1.12 “[*****]
Transaction
Agreement” shall mean an agreement pursuant to which
Apollo or any of its Affiliates has [*****] either solely in [*****] or in [*****] and one or more of the following
countries: [*****]. For
clarity, an agreement pursuant to which Apollo or any of its
Affiliates have [*****] in
regions in addition to [*****]
or one or more of the countries listed above (including globally)
shall not be considered a “[*****] Transaction Agreement”
hereunder.
1.13 “Licensed
IP” shall mean all rights licensed or otherwise
granted to VistaGen from UHN under each License Agreement,
including the UHN Patent Rights.
1.14 “Licensed
Product” shall mean [*****].
___________________
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
1.15 “Improvements”
means any and all [*****].
1.16 “IND”
means (a) an Investigational New Drug Application as defined in the
United States Federal Food, Drug and Cosmetic Act, as amended, and
applicable regulations promulgated thereunder by the FDA, or (b)
the equivalent application to the equivalent regulatory authority
in any other regulatory jurisdiction, the filing of which is
necessary to initiate or conduct clinical testing of a biologic or
pharmaceutical product candidate in humans in such
jurisdiction.
1.17
“Net Sales” shall mean
[*****]
(a) [*****]
(b) [*****]
(c) [*****]
(d) [*****]
[*****].
In the
event that a Revenue Bearing Product is sold as a Combination
Product, Net Sales, for the purposes of determining royalty
payments on the Combination Product, shall mean [*****]:
(i) [*****]
(ii) [*****].
1.18 “Orphan
Indication” means a disease or condition for which a
product intended to treat such disease or condition has received
orphan drug status from the FDA or European Medicines Agency (the
“EMA”).
1.19 “Phase
2 Clinical Trial” means a human clinical trial of a
product, the principal purpose of which is a determination of
safety and efficacy in the target patient population, as described
in 21 C.F.R. 312.21(b) (as amended or any replacement thereof), or
a similar clinical trial prescribed by the regulatory authority in
a country other than the United States.
1.20 “Phase
3 Clinical Trial” means a human clinical trial of a
product, the design of which is acknowledged by the FDA to be
sufficient for such clinical trial to satisfy the requirements of
21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a
similar human clinical trial prescribed by the regulatory authority
to be sufficient for such clinical trial to satisfy the
requirements of a pivotal efficacy and safety clinical
trial.
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
1.21 “Present
Improvement” shall mean any Improvement in existence
on the Effective Date.
1.22 “Regulatory
Approval” means all approvals necessary for the
manufacture, marketing, importation and sale of a product for one
or more indications in a country or regulatory jurisdiction, which
may include satisfaction of all applicable regulatory and
notification requirements, including any pricing and reimbursement
approvals. Regulatory Approvals include approvals by regulatory
authorities of INDs, marketing authorization approvals, new drug
applications or biologics license applications.
1.23 “Reporting
Period” shall begin
on the first day of each calendar quarter and end on the last day
of such calendar quarter.
1.24 “Revenue
Bearing Products” shall mean a Licensed Product
[*****].
1.25 “Sublicensee”
shall
mean any non-Affiliate sub-sublicensee or sublicensee, as
applicable, of the rights granted by Apollo pursuant to
Section 2.2.
1.26 “Term”
shall
have the meaning set forth in Section 12.1.
1.27 “Territory”
shall
mean worldwide.
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
1.28
“UHN Patent Rights” shall
mean:
(a) the
United States and international patents licensed to VistaGen from
UHN pursuant to each License Agreement, including those listed on
Exhibit
A;
(b) the
United States and international patent applications and provisional
applications licensed to VistaGen from UHN pursuant to each License
Agreement, including those listed on Exhibit A;
(c) any
patent applications claiming priority from the patents, patent
applications, or provisional applications licensed to VistaGen from
UHN pursuant to each License Agreement, including those listed on
Exhibit A, and any
direct or indirect divisionals, continuations, continuation-in-part
applications, and continued prosecution applications (and their
relevant international equivalents) of the patent applications
licensed to VistaGen from UHN pursuant to each License Agreement,
including those listed on Exhibit A and of such patent
applications claiming priority from the provisional applications
licensed to VistaGen from UHN pursuant to each License Agreement,
including those listed on Exhibit A, to the extent
the claims are directed to subject matter specifically described in
the patent applications licensed to VistaGen from UHN pursuant to
each License Agreement, including those listed on Exhibit A, and the resulting
patents;
(d) any
patents resulting from reissues, reexaminations, or extensions (and
their relevant international equivalents, including, without
limitation supplementary protection certificates) of the patents
described in clauses (a), (b) and (c) above;
and
(e) international
(non-United States) patent applications and provisional
applications filed after the Effective Date and the relevant
international equivalents to divisionals, continuations,
continuation-in-part applications and continued prosecution
applications of the patent applications to the extent the claims
are directed to subject matter specifically described in the
patents or patent applications referred to in clauses (a),
(b), (c) and (d) above.
Notwithstanding
the foregoing, to the extent there is a conflict between the
content of Exhibit A and that listed in Exhibit B of each License
Agreement, the content of Exhibit B of each License Agreement shall
control.
1.29 “Valid
Claim” shall mean [*****].
1.30 “VistaGen
Field of Use” shall mean all fields other than the
Apollo Field of Use. [*****].
___________________
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
ARTICLE 2
GRANT
OF RIGHTS
(a) VistaGen
hereby grants to Apollo and its Affiliates for the Term a
royalty-bearing, exclusive (even as to VistaGen and its Affiliates,
except as set forth in Section 2.3) sublicense, with the right to
grant further sublicenses (as provided in Section 2.2 below)
through multiple tiers, under the Licensed IP, to research,
develop, commercialize, make, have made, use, have used, sell, have
sold, offer to sell, have offered for sale, import, have imported
and otherwise exploit, itself and through third parties, Licensed
Products in the Apollo Field of Use in the Territory.
(b) VistaGen
hereby grants to Apollo and its Affiliates for the Term a
royalty-free, exclusive (even as to VistaGen and its Affiliates)
license, with the right to grant sublicenses (as provided in
Section 2.2 below) through multiple tiers, under the Present
Improvements, to research, develop, commercialize, make, have made,
use, have used, sell, have sold, offer to sell, have offered for
sale, import, have imported and otherwise exploit, itself and
through third parties, Licensed Products in the Apollo Field of Use
in the Territory.
(c) VistaGen
hereby grants to Apollo and its Affiliates for the Term a
royalty-free, non-exclusive license, with the right to grant
sublicenses (as provided in Section 2.2 below) through multiple
tiers, under the Future Improvements, to research, develop,
commercialize, make, have made, use, have used, sell, have sold,
offer to sell, have offered for sale, import, have imported and
otherwise exploit, itself and through third parties, Licensed
Products in the Apollo Field of Use in the Territory.
(d)
VistaGen
acknowledges and agrees that, during the Term, it shall not
directly or indirectly grant any licenses, sublicenses or other
rights inconsistent with this Section 2.1.
(e) Apollo
acknowledges and agrees that, during the Term, it, its Affiliates
and its Sublicensees under this Agreement will comply with any
provision of the License Agreements if and to the extent such
provision is applicable to a sublicensee under the License
Agreements.
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
Apollo
shall have the right to grant further sublicenses of the rights and
licenses granted to Apollo hereunder through multiple tiers. Apollo
shall incorporate terms and conditions into its sublicense
agreements sufficient to enable Apollo to comply with this
Agreement. Apollo shall promptly furnish VistaGen with a fully
signed photocopy of any sublicense agreement, which sublicense
agreement may be redacted as necessary to protect commercially
sensitive information. Upon termination of this Agreement for any
reason, provided that a Sublicensee is not in material breach of
its sublicense, VistaGen shall grant to such Sublicensee sublicense
rights and terms equivalent to the sublicense rights and terms
which Apollo previously granted to such Sublicensee.
2.3 Retained
Rights
(a) VistaGen
shall retain the licenses granted to it by UHN pursuant to each
License Agreement to use the Licensed IP in accordance with the
terms of each License Agreement solely in the VistaGen Field of
Use.
(b) Apollo
acknowledges UHN’s reserved right under each License
Agreement to retain a non-exclusive, sublicensable right to use the
Licensed IP for non-commercial research purposes and/or academic
educational purposes, without any financial obligation to VistaGen
or Apollo for so using the Licensed IP.
(c) Apollo
acknowledges that, with respect to UHN, the U.S. federal government
retains a royalty-free, non-exclusive, non-transferable license to
practice any government-funded invention claimed in any UHN Patent
Rights as set forth in
35 U.S.C. §§ 01-211, and the regulations
promulgated thereunder, as amended, or any successor statutes or
regulations.
2.4 No
Additional Rights. Nothing in this
Agreement shall be construed to confer any rights upon Apollo by
implication, estoppel, or otherwise as to any patent rights or
other intellectual property of VistaGen or UHN other than the
Licensed IP and Improvements.
2.5 VistaGen
SRA. VistaGen covenants and agrees to promptly notify Apollo
(but in no event later than [*****] after receipt) in the event it
receives any Invention Notice (as defined in the VistaGen SRA)
applicable to [*****] the
Apollo Field of Use from UHN following the Effective Date. For
clarity, [*****]. In addition,
VistaGen hereby assigns all right, title and interest in and to any
unexercised or future option available to VistaGen pursuant to
Section 4.3 of the VistaGen SRA, through which VistaGen may obtain
an exclusive license to any Resulting IP (as defined in the
VistaGen SRA) in the field set forth in [*****] Apollo Field of Use disclosed in
such Invention Notice. To the extent Apollo, in its sole
discretion, decides to exercise such option to obtain an exclusive
license, it shall notify VistaGen of its decision within
[*****] days of receipt of
notice from VistaGen. VistaGen shall promptly (within the required
time periods set forth in the VistaGen SRA) notify UHN of such
decision on behalf of Apollo and acquire exclusive license rights
to the applicable Resulting IP through the procedures set forth in
Section 4.3 of the VistaGen SRA; provided that (i) the terms and
conditions of each such exclusive license agreement shall be
substantially identical to the terms and conditions set forth in
the License Agreements and (ii) each such exclusive license
agreement shall automatically be considered a License Agreement
hereunder with all rights licensed or otherwise granted to VistaGen
thereunder automatically considered Licensed IP hereunder with the
field in clause (ii) of the Apollo Field of Use applying to such
Licensed IP. Apollo and VistaGen shall endeavor to amend Exhibit A
attached hereto to reflect such additional Licensed IP. Apollo
shall reimburse VistaGen to the extent VistaGen pays an issue fee
to UHN pursuant to each such exclusive license, which reimbursement
shall not exceed [*****]. For
the avoidance of doubt, in accordance with this Agreement, VistaGen
shall retain the licenses granted to it by UHN solely within the
VistaGen Field of Use under any such license agreement entered into
pursuant to this Section 2.5.
2.6
Future UHN SRA. During the Term
and for a period of [*****]
thereafter, neither VistaGen nor any of its Affiliates or
sublicensees (other than Apollo and its Affiliates, licensees and
Sublicensees), either alone, or with or through any third party
(including by way of any assignment, license, covenant or other
transaction regarding patent rights or other intellectual property,
or by any research, development or other agreement), shall enter
into any agreement with UHN in the field set forth in [*****] the Apollo Field of
Use.
2.7 Section
365(n) of the Bankruptcy Code. All rights and licenses
granted pursuant to any Section of this Agreement are, and shall be
deemed to be, rights and licenses to “intellectual
property” (as defined in Section 101(35A) of title 11 of the
United States Code and of any similar provisions of applicable
Bankruptcy Code under any other jurisdiction including the
Bankruptcy and Insolvency Act, R.S.C. 1985, c. B-3 and
Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36,
as amended from time to time. VistaGen agrees that Apollo as a
licensee and sublicensee of rights and licenses under this
Agreement, shall retain and may fully exercise all of its rights
and elections under the Bankruptcy Code. The Parties further agree
that, in the event of the commencement of a bankruptcy proceeding
by or against VistaGen under the Bankruptcy Code or analogous
provisions of applicable laws outside the United States, Apollo
shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any patent rights or other intellectual
property licensed or sublicensed to Apollo and all embodiments of
such intellectual property, which, if not already in Apollo’s
possession, shall be promptly delivered to it (a) upon any such
commencement of a bankruptcy proceeding upon Apollo’s written
request therefor, unless VistaGen in the bankruptcy proceeding
elects to continue to perform all of its obligations under this
Agreement or (b) if not delivered under clause (a), following the
rejection of this Agreement in the bankruptcy proceeding, upon
written request therefor by Apollo.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
ARTICLE 3
APOLLO
DILIGENCE OBLIGATIONS AND REPORTING
3.1 Diligence
Requirements. Apollo shall use
commercially reasonable efforts, or shall cause one or more of its
Affiliates and Sublicensees to use commercially reasonable efforts,
to develop [*****]. In the
event that VistaGen determines that Apollo (itself or through its
Affiliates or Sublicensees) has failed to fulfill its obligations
under this Section 3.1, then VistaGen may treat such failure as a
material breach in accordance with
Section 12.3(a).
3.2 R&D
Plan. Within [*****]
after the Effective Date, Apollo shall furnish to VistaGen a copy
of Apollo’s Research and Development Plan
(“R&D
Plan”) for Licensed Products; and a status and
progress report as to Apollo’s implementation of the R&D
Plan shall be furnished to VistaGen annually thereafter, in
conjunction with submission to VistaGen of the annual report,
together with an update for the R&D Plan for the next year. The
Parties acknowledge that the R&D Plan will represent the
optimal and desired goals and timeline for [*****], and that there is no guarantee of
achieving the goals within said timeline.
3.3 Annual
Report. [*****] each
Calendar Year during the Term, Apollo shall prepare and deliver to
VistaGen a written summary report which shall describe (a) the
research performed to date employing the Licensed IP, (b) the
progress of [*****] Licensed
Products [*****] and (c)
[*****].
ARTICLE 4
4.1 Consideration
for Grant of Rights
(a) License
and Sublicense Issue. Within [*****], Apollo shall pay to VistaGen a
sublicense and license issue fee of One Million Two Hundred Fifty
Thousand U.S. dollars (U.S.$1,250,000). [*****].
(b) Running
Royalties. Beginning upon the First Commercial Sale of a
Revenue Bearing Product, Apollo shall pay to VistaGen a
[*****] royalty on a
[*****] basis on [*****] Net Sales for [*****]. Running royalties shall be
payable for each Reporting Period and shall be due to VistaGen
within [*****] of the end of
each Reporting Period.
(c)
Royalty Stacking. To the extent
that Apollo or any of its Affiliates or Sublicensees obtains
licenses to third party patent rights or other intellectual
property in order to practice the Licensed IP or to develop or
commercialize any Licensed Products, Apollo and its Affiliates and
Sublicensees may deduct from any royalty due to VistaGen hereunder
[*****] of the royalties due
according to agreements between Apollo (and its Affiliates and
Sublicensees, as applicable) and a third party(ies) on such patents
or intellectual property up to an amount equal to [*****] of the running royalties owed in
any Reporting Period hereunder, with any excess third party
royalties carried over into next succeeding Reporting Periods until
exhausted.
(d)
Biosimilar
Competition. Notwithstanding the foregoing, on a
country-by-country basis in the Territory, the royalty rate for Net
Sales of a Revenue Bearing Product set forth in
Section 4.1(b) shall be reduced
(A) by [*****], following a
launch of a Biosimilar Product, if the unit sales of all Biosimilar
Products in such country exceed [*****] of the sum of unit sales of
Revenue Bearing Products plus unit sales of all Biosimilar Products
in such country, (B) by [*****] following a launch of a Biosimilar
Product, if the unit sales of all Biosimilar Products in such
country exceed [*****] of the
sum of unit sales of Revenue Bearing Products plus unit sales of
all Biosimilar Products in such country, or (C) by [*****] to become [*****] following a launch of Biosimilar
Product, if the unit sales of all Biosimilar Products in such
country exceed [*****] of the
sum of unit sales of Revenue Bearing Products plus unit sales of
all Biosimilar Products in such country. Unless otherwise agreed by
the Parties, the unit sales of each such Biosimilar Product sold
during a Reporting Period shall be as reported by [*****] or any other independent sales
auditing firm reasonably agreed upon by the Parties.
___________________
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
(e) No
Multiple Royalties. If the commercial sale of any Revenue
Bearing Product is covered by more than one of the [*****], multiple royalties shall not be
due.
(f) Duration
of Royalty Obligations. The royalty obligations of Apollo
shall continue on a country-by-country basis as to each Revenue
Bearing Product, until the expiration or termination of the last to
expire Valid Claim within UHN Patent Rights that covers
[*****] such Revenue Bearing
Product in that country. Upon the expiration of Apollo’s
royalty obligations with respect to a Revenue Bearing Product in a
country, the license grants contained in Sections 2.1 shall become fully paid-up, royalty-free,
perpetual and irrevocable for such Revenue Bearing Product in such
country.
(g) Development
Milestone Payments. Subject to Section 4.1(h), Apollo shall pay to VistaGen the
following development milestone payments listed in the tables below
for [*****] Revenue Bearing
Product to achieve each development milestone event. Apollo shall
provide VistaGen with written notice and such milestone payment
within [*****] after achieving
each development milestone. Each such milestone payment shall be
payable only once on the [*****] Revenue Bearing Product to achieve
such development milestone event. For the avoidance of doubt, in no
event shall Apollo be required to pay VistaGen more than an
aggregate of Seven Million, Eight Hundred Thousand U.S. dollars
(U.S.$7,800,000) in development milestone payments under this
Section 4.1(g).
___________________
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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-11-
Exclusive License and Sublicense Agreement
|
|
Development Milestone Event
|
Milestone Payment
|
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(A)
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[*****]
|
[*****]
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(B)
|
[*****]
|
[*****]
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|
(C)
|
[*****]
|
[*****]
|
|
(D)
|
[*****]
|
[*****]
|
(i) [*****]
(ii) [*****]
(iii) [*****].
(i) Commercial Milestone Payments.
Apollo shall pay to VistaGen the following commercial milestone
payments listed in the tables below after achievement of
[*****] commercial milestone
event. Apollo shall provide VistaGen with written notice and such
milestone payment within [*****] after the end of the Calendar Year
in which the applicable milestone event was achieved. Each such
milestone payment shall be payable only once. For the avoidance of
doubt, in no event shall Apollo be required to pay VistaGen more
than an aggregate of Twenty-Nine Million U.S. dollars ($29,000,000)
in commercial milestone payments under this Section 4.1(i).
|
|
Commercial Milestone Event
|
Milestone Payment
|
|
(A)
|
[*****]
|
[*****]
|
|
(B)
|
[*****]
|
[*****]
|
|
(C)
|
[*****]
|
[*****]
|
|
(D)
|
[*****]
|
[*****]
|
(j) [*****]
Transaction Agreement
Revenue.
(i) Subject
to Sections 4.1(j)(ii), Apollo
shall pay VistaGen the following percentage of all consideration
allocable solely to [*****]
received by Apollo pursuant to the [*****] Transaction
Agreement:
(A) [*****]
(B) [*****]
(C) [*****].
Apollo
shall provide VistaGen with written notice of [*****] Transaction Agreement and payment
of the amount represented by the above percentages within
[*****] after [*****]. [*****].
(ii) The
following shall not be considered consideration and subject to the
sharing percentages in Section 4.1(j)(i): [*****].
(iii) To
the extent that patent rights, other intellectual property rights
or other rights, products or obligations other than those
applicable to Revenue Bearing Products are [*****] Transaction Agreement, that
portion of the consideration received by Apollo and subject to
Section 4.1(j)(i) shall be equitably apportioned
between the Revenue Bearing Products and those other rights,
products and obligations, and such apportionment shall be
reasonable and in accordance with customary standards in the
industry.
___________________
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*****
|
VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
|
-12-
Exclusive License and Sublicense Agreement
(iv) To
the extent Apollo [*****]
Transaction Agreement, that portion of the consideration received
by Apollo and subject to Section 4.1(j)(i) shall be equitably apportioned
between [*****] and any other
such applicable country, and such apportionment shall be reasonable
and in accordance with customary standards in the industry.
[*****].
(v) With
respect to each of Sections 4.1(j)(iii) and 4.1(j)(iv), Apollo shall promptly deliver to
VistaGen a written report setting forth each such apportionment. In
the event VistaGen disagrees with the determination made by Apollo,
VistaGen shall so notify Apollo within [*****] of receipt of Apollo’s
report and the Parties shall meet to discuss and resolve such
disagreement in good faith. If the Parties are unable to agree in
good faith as to such fair market values within [*****], then (a) the matter shall be
submitted in accordance with the dispute resolution process set
forth in Article 13, and (b) VistaGen
shall not be entitled to terminate this Agreement until such matter
is fully determined by a court of competent
jurisdiction.
(k) Method
of Payment. All payments shall be made by wire transfer of
immediately available funds into an account designated by
VistaGen.
(l)
Payments in U.S. Dollars. All
payments due under this Agreement shall be payable in United States
dollars. Conversion of foreign currency to U.S. dollars shall be
made at the conversion rate existing in the United States (as
reported in the Wall Street Journal) on the last working day of the
calendar quarter of the applicable Reporting Period. Such payments
shall be without deduction of exchange, collection, or other
charges, and, specifically, without deduction of withholding or
similar taxes or other government imposed fees or taxes, except as
permitted in the definition of Net Sales.
(m) Late
Payments. Any payments by Apollo that are not paid on or
before the date such payments are due under this Agreement shall
bear interest, to the extent permitted by law, at [*****] above the Prime Rate of interest
as reported in the Wall Street Journal on the date payment is
due.
(n) Payments
to UHN. VistaGen shall be solely responsible for any and all
amounts payable to UHN pursuant to the terms of each License
Agreement, including any amounts payable as a result of, or in
connection with, entry by the Parties into this Agreement or any
milestone achieved by, or royalties on Net Sales of, any Revenue
Bearing Product. In no event shall Apollo be responsible or liable
for any amounts due and payable to UHN under any License Agreement
or the VistaGen SRA.
ARTICLE 5
REPORTS,
RECORDS AND CONFIDENTIAL INFORMATION
5.1 Frequency
of Reports.
(a) Upon
First Commercial Sale of a Revenue Bearing Product. Apollo
shall report to VistaGen the date of the First Commercial Sale of a
Revenue Bearing Product within [*****] of occurrence in each
country.
(b) After
First Commercial Sale. After the First Commercial Sale of a
Revenue Bearing Product, Apollo shall deliver reports to VistaGen
within [*****] of the end of
each Reporting Period, containing information concerning the
immediately preceding Reporting Period, as further described in
Section 5.2.
5.2 Content
of Reports and Payments. Each report
delivered by Apollo to VistaGen shall contain at least the
following information for the immediately preceding Reporting
Period:
(a) the
number of Revenue Bearing Products sold by Apollo, its Affiliates
and Sublicensees to independent third parties in each
country;
(b) the
gross price charged by Apollo, its Affiliates and Sublicensees for
each Revenue Bearing Product in each country;
(c) calculation
of Net Sales for the applicable Reporting Period in each country,
including, without limitation, a listing of applicable deductions;
and
(d) total
royalty payable on Net Sales in U.S. dollars, together with the
exchange rates used for conversion.
If no
amounts are due to VistaGen for any Reporting Period, the report
shall so state.
5.3 Records.
Apollo shall maintain, and shall cause its Affiliates and
Sublicensees to maintain, complete and accurate records relating to
amounts payable to VistaGen in relation to this Agreement. The
relevant entity shall retain such records for at least [*****] following the end of the Calendar
Year to which they pertain, during which time a certified,
independent public accountant selected by VistaGen and reasonably
acceptable to Apollo shall have the right, at VistaGen’s
expense, to inspect such records during normal business hours to
verify any reports and payments made or compliance in other
respects under this Agreement. In the event that any audit
performed under this Section 5.3
reveals an underpayment in excess of [*****], Apollo shall bear the full
out-of-pocket cost of such audit and shall remit any amounts due to
VistaGen within [*****] of
receiving written notice thereof from VistaGen.
___________________
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*****
|
VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
|
-13-
Exclusive License and Sublicense Agreement
5.4
Confidentiality of Reports and Records. The reports and
records (including the R&D Plan) provided by Apollo hereunder
shall be regarded as Apollo’s Confidential Information (as
defined below) and, notwithstanding Section 5.5 below, VistaGen hereby covenants that it
shall not use or disclose any information included in such reports
for any purpose other than determining whether Apollo, its
Affiliates and Sublicensees have complied with their obligations
under this Agreement; provided that VistaGen may disclose such
reports to UHN solely to use for the same purpose. VistaGen further
agrees that, notwithstanding Section 5.5 below, until such time as such information
is no longer confidential through no fault of VistaGen, it shall
maintain such reports and any information included therein in
strict confidence and treat such information in a manner at least
as restrictive as its manner of treating its own confidential
information of similar nature and in any event not less than with a
reasonable degree of care.
(a) Confidential
Information; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, during
the Term and for a period of [*****] thereafter, the Parties hereby
agree to hold in strict confidence and not publish, disclose or
transfer, directly or indirectly, or use for any purpose other than
as provided for in this Agreement any information and materials
furnished to it by or on behalf of the other Party or its
Affiliates or generated pursuant to this Agreement (collectively,
“Confidential
Information”). For clarity, Confidential Information
of a Party or its Affiliates will include, without limitation, all
information and materials disclosed by such Party or its Affiliates
or their respective designees that (a) is marked as
“Confidential,” “Proprietary” or with
similar designation at the time of disclosure or (b) by its
nature can reasonably be expected to be considered Confidential
Information by the recipient. Information disclosed orally will not
be required to be identified as such to be considered Confidential
Information. The terms of this Agreement shall be deemed to be the
Confidential Information of both Parties. Notwithstanding the
foregoing, Confidential Information will not include any
information to the extent that it can be established by written
documentation by the receiving Party that such information: (a) was
already known to the receiving Party, other than under an
obligation of confidentiality (except to the extent such obligation
has expired or an exception is applicable under the relevant
agreement pursuant to which such obligation was established), at
the time of disclosure, (b) was generally available to the public
or otherwise part of the public domain at the time of its
disclosure to the receiving Party, (c) became generally available
to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the
receiving Party in breach of this Agreement, (d) was independently
developed by the receiving Party as demonstrated by written
documentation prepared contemporaneously with such independent
development; or (e) was disclosed to the receiving Party, other
than under an obligation of confidentiality (except to the extent
such obligation has expired or an exception is applicable under the
relevant agreement pursuant to which such obligation was
established), by a third party who had no obligation to the
disclosing Party not to disclose such information to
others.
(b)
Authorized Disclosure. Except as
expressly provided otherwise in this Agreement, each Party may use
and disclose Confidential Information of the other Party solely as
follows: (a) under appropriate confidentiality provisions
substantially equivalent to those in this Agreement: (i) in
connection with the performance of its obligations or as reasonably
necessary or useful in the exercise of its rights under this
Agreement, including the right to grant licenses or sublicenses as
permitted hereunder, or (ii) to actual or potential
bona fide (sub)licensees,
acquirers or assignees, collaborators, investment bankers,
investors or lenders with whom a Party (or its Affiliates) has
entered into good faith negotiations regarding a proposed
transaction, or; (b) to the extent such disclosure is to a
governmental authority as reasonably necessary in filing or
prosecuting the UHN Patent Rights or Present Improvement Patent
Rights, copyright and trademark applications in accordance with
this Agreement, prosecuting or defending litigation related to this
Agreement, complying with applicable governmental regulations with
respect to performance under this Agreement, obtaining Regulatory
Approval or fulfilling post-approval regulatory obligations for the
Licensed Products, or otherwise required by applicable law;
provided, however, that if
a Party is required by applicable law or the rules of any
securities exchange or automated quotation system to make any such
disclosure of the other Party’s Confidential Information it
will, except where impracticable for necessary disclosures (for
example, in the event of medical emergency), give reasonable
advance notice to the other Party of such disclosure requirement
and, in each of the foregoing, will use its reasonable efforts to
secure confidential treatment of such Confidential Information
required to be disclosed and will only disclosed that Confidential
Information that is required to be disclosed; (c) to advisors
(including lawyers and accountants) on a need to know basis, in
each case under appropriate confidentiality provisions or
professional standards of confidentiality substantially equivalent
to those of this Agreement, or (d) to the extent mutually
agreed to by the Parties. Each Party acknowledges and agrees that
the other Party may submit this Agreement to the SEC and if a Party
does submit this Agreement to the SEC, such Party agrees to consult
with the other Party with respect to the preparation and submission
of, a confidential treatment request for this Agreement. If a Party
is required by applicable law to make a disclosure of the terms of
this Agreement in a filing with or other submission to the SEC, and
[*****], then such Party will
have the right to make such public disclosure at the time and in
the manner reasonably determined by its counsel to be required by
applicable law. Notwithstanding anything to the contrary herein, it
is hereby understood and agreed that if a Party seeking to make a
disclosure to the SEC as set forth in this Section 5.5(b), [*****] such comments, limit disclosure or
obtain confidential treatment to the extent reasonably requested by
the other Party.
(c) Press
Releases. Neither Party may issue any press release or make
any other public announcement or statement concerning this
Agreement, the transactions contemplated hereby or the terms
hereof, without the prior written approval of the other Party,
except as may be required by applicable law. In the event either Party (the
“Issuing
Party”) desires to issue
a press release or other public statement disclosing information
relating to this Agreement, the
transactions contemplated hereby or the terms hereof, the Issuing
Party will provide the other Party (the “Reviewing
Party”) with a copy of
the proposed press release or public statement (the
“Release”)
and seek the Reviewing Party’s prior written
consent. The Issuing Party will
specify with each such Release, taking into account the urgency of
the matter being disclosed, a reasonable period of time within
which the Receiving Party may provide any comments on such
Release and if the Receiving Party fails to provide any
comments during the response period called for by the Issuing
Party, the Reviewing Party will be deemed to have consented to the
issuance of such Release. If the
Receiving Party provides any comments, the Parties will consult on
such Release and work in good faith to prepare a mutually
acceptable Release. Either Party may subsequently publicly disclose
any information previously contained in any Release so consented
to.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
-14-
Exclusive License and Sublicense Agreement
ARTICLE 6
PATENT
PROSECUTION
6.1 Responsibility
for UHN Patent Rights. Pursuant to each
License Agreement, VistaGen has the right to control the
preparation, filing, prosecution, defense in post-grant or
post-issuance administrative proceedings, and maintenance of all
patents and patent applications in respect of the UHN Patent Rights
in the Territory. VistaGen hereby grants to Apollo the sole and
exclusive right to exercise all of its rights regarding patent
prosecution, maintenance and enforcement under each License
Agreement, and VistaGen hereby appoints Apollo to act as its agent,
to prepare, file, prosecute, maintain and defend in all agency
proceedings (e.g., reissues, reexaminations, oppositions and
interferences) all of the UHN Patent Rights during the Term.
Likewise, VistaGen hereby grants to Apollo the sole and exclusive
right to prepare, file, prosecute, maintain and defend in all
agency proceedings (e.g., reissues, reexaminations, oppositions and
interferences) any and all patent rights within the Present
Improvements (the “Present Improvement Patent
Rights” and together with Future Improvement Patent
Rights, “Improvement
Patent Rights”) during the Term. With respect to the
foregoing, Apollo shall copy VistaGen on all patent prosecution
documents and give VistaGen reasonable opportunities to advise
Apollo on such filing, prosecution and maintenance. In the event
Apollo desires to abandon any patent or patent application within
the UHN Patent Rights or Present Improvement Patent Rights, Apollo
shall provide VistaGen with reasonable prior written notice of such
intended abandonment or decline of responsibility. If VistaGen
elects to continue such patent or patent application, the Parties
shall consult and Apollo may elect to retain responsibility
therefor. Otherwise, the right to prepare, file, prosecute,
maintain and defend the relevant UHN Patent Rights or Present
Improvement Patent Rights, at VistaGen’s expense, shall
revert to VistaGen and with respect to the UHN Patent Rights shall
be subject to the terms and conditions of the applicable License
Agreement.
6.2 Payment
of Expenses. The Parties
acknowledge and agree that pursuant to each License Agreement,
payment of all fees and costs, including, without limitation,
attorney’s fees, for the filing, prosecution and maintenance
of the UHN Patent Rights incurred by UHN before the Effective Date
shall be the responsibility of VistaGen. Apollo shall be
responsible for all such fees and costs incurred after the
Effective Date. For the avoidance of doubt, Apollo shall not be
responsible for payment of any fees and costs associated with the
prosecution and maintenance of the UHN Patent Rights or Present
Improvement Patent Rights incurred prior to the Effective
Date.
6.3 Patent
Extensions and Orange or Purple Book
Listings. If elections with
respect to obtaining patent term extensions (including, without
limitation, any available pediatric extensions) or supplemental
protection certificates or their equivalents in any country with
respect to UHN Patent Rights or Present Improvement Patent Rights
are available, Apollo shall have the sole and exclusive right to
make any such elections based on Licensed Products. With respect to
data exclusivity periods (such as those periods listed in the
FDA’s Orange or Purple Book (including, without limitation,
any available pediatric extensions) or periods under national
implementations of Article 10.1(a)(iii) of
Directive 2001/EC/83 or orphan exclusivity periods, and all
equivalents in any country), Apollo shall have the sole and
exclusive right to seek and maintain all such data exclusivity
periods available for the Licensed Products. With respect to all of
the rights and activities identified in this Section 6.3, VistaGen hereby appoints Apollo as its
agent for such purposes with the authority to act on
VistaGen’s behalf with respect to the UHN Patent Rights or
Present Improvement Patent Rights in a manner consistent with this
Agreement.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
-15-
Exclusive License and Sublicense Agreement
INFRINGEMENT
7.1 Notification
of Infringement of Licensed IP or
Improvements. Each Party agrees
to provide written notice to the other Party promptly after
becoming aware of any infringement of the Licensed IP or
Improvements by a third party and of any available evidence
thereof, including to the extent VistaGen receives notice from UHN
of any infringement of the Licensed IP by a third party and of any
available evidence thereof.
7.2 Right
to Prosecute Infringements. Pursuant to each
License Agreement, VistaGen has the right to determine the
appropriate course of action to enforce the Licensed IP or
otherwise xxxxx the infringement thereof, to take (or refrain from
taking) appropriate action to enforce the Licensed IP, to defend
any declaratory judgments seeking to invalidate or hold the
Licensed IP unenforceable, to control any litigation or other
enforcement action and to enter into, or permit, the settlement of
any such litigation, declaratory judgments or other enforcement
action with respect to Licensed IP.
(a) Apollo
Right to Prosecute. VistaGen hereby assigns to Apollo the
first and exclusive right, but not the obligation, under its own
control and at its own expense, to prosecute any third party
infringement of the Licensed IP or Present Improvements, subject to
Sections 7.4 and 7.5. The total cost of any such infringement
action commenced or defended solely by Apollo shall be borne by
Apollo.
(b) VistaGen
Right to Prosecute. If within [*****] after having been notified of any
alleged infringement that is material and competitive in the
marketplace Apollo is unsuccessful in persuading the alleged
infringer to desist and shall not have brought and shall not be
diligently prosecuting an infringement action, then VistaGen shall
have the right, but shall not be obligated, under its own control
and at its own expense, to prosecute any infringement of the
Licensed IP or Present Improvements, and, with respect to the
Licensed IP, the terms and conditions of the applicable License
Agreement shall govern.
7.3 Declaratory
Judgment Actions. If a declaratory
judgment action is brought naming UHN, VistaGen or Apollo or any of
its Affiliates or Sublicensees as a defendant and alleging
invalidity, unenforceability or non-infringement of any UHN Patent
Rights or Improvement Patent Rights, Apollo or VistaGen, as the
case may be, shall promptly notify the other Party in writing and
Apollo may elect, upon written notice to VistaGen within
[*****] after receiving or
giving notice of the commencement of such action, to take over the
sole control of such action at its own expense solely with respect
to UHN Patent Rights or Present Improvement Patent Rights. If
Apollo does not defend any such action, then VistaGen shall have
the right, but shall not be obligated, to defend such action at
VistaGen’s expense and, with respect to the UHN Patent
Rights, the terms of the applicable License Agreement shall
govern.
7.4 Offsets.
Apollo may offset a total of [*****] of any expenses incurred under
Sections 7.2 and 7.3 against any payments due to VistaGen under
Article 4, provided that in no event
shall such payments under Article 4,
when aggregated with any other offsets and credits allowed under
this Agreement, be reduced by more than [*****] in any Reporting
Period.
7.5 Recovery.
In the event that either Party exercises the rights conferred in
this Article 7 and recovers any
damages or other sums in such action, such damages or other sums
recovered shall first be applied to all out-of-pocket costs and
expenses incurred by the Parties in connection therewith
(including, without limitation, attorneys’ fees). If such
recovery is insufficient to cover all such costs and expenses of
both Parties, the controlling Party’s costs shall be paid in
full first before any of the other Party’s costs. If after
such reimbursement any funds shall remain from such damages or
other sums recovered, such funds shall be retained by the Party
that controlled the action or proceeding under this Article 7; provided, however, that (a) if
Apollo is the Party that controlled such action or proceeding,
VistaGen shall receive out of any such remaining recovery received
by Apollo an amount equal to royalties payable hereunder by
treating such remaining recovery as “Net Sales”
hereunder and (b) if VistaGen is the Party that controlled
such action or proceeding, the remaining recovery received by
VistaGen shall be shared equally between Apollo and
VistaGen.
7.6 Cooperation.
Each Party agrees to cooperate in any action under this Article 7 which is controlled by the other
Party, including, without limitation, joining such action as a
party plaintiff if necessary or desirable for initiation or
continuation of such action; provided that the controlling Party
reimburses the cooperating Party promptly for any reasonable costs
and expenses incurred by the cooperating Party in connection with
providing such assistance.
___________________
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|
|
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
-16-
Exclusive License and Sublicense Agreement
ARTICLE 8
8.1 Indemnification
of VistaGen. Apollo hereby
agrees to indemnify, defend and hold harmless each of VistaGen and
its Affiliates and its and their trustees, directors, officers,
employees, scientists, agents, successors, assigns and other
representatives (collectively, the “VistaGen Indemnitees”)
from and against all damages, liabilities, losses and other
expenses, including, without limitation, reasonable
attorney’s fees, expert witness fees and costs (collectively,
“Losses”), regarding any
claims, suits or proceedings brought by a third party, whether or
not a lawsuit or other proceeding is filed
(collectively “Claim”), that arise out
of or relate to (a) any product, process, or service that is
made, used, sold, imported, or performed by or on behalf of Apollo
pursuant to any right or license granted under this Agreement,
(b) Apollo’s failure to comply with any applicable laws,
rules or regulations in connection with this Agreement and
(c) the [*****] of
Apollo, except that Apollo’s liability for damages under its
indemnity shall be reduced or apportioned to the extent any claim
is proximately caused by VistaGen’s [*****]. [*****].
8.2 Indemnification
of Apollo. VistaGen hereby agrees to indemnify, defend and
hold harmless Apollo and its Affiliates and its and their trustees,
directors, officers, employees, scientists, agents, successors,
assigns and other representatives (collectively, the
“Apollo
Indemnitees”) from and against all Losses regarding
any Claims that arise out of or relate to (a) any product,
process, or service that is made, used, sold, imported, or
performed by or on behalf of VistaGen using or incorporating the
Licensed IP, (b) VistaGen’s failure to comply with any
applicable laws, rules or regulations in connection with this
Agreement, (c) any Claims brought by UHN with respect to any
payments due and payable to UHN under any License Agreement and
(d) the [*****] of
VistaGen, except that VistaGen’s liability for damages under
its indemnity shall be reduced or apportioned to the extent any
claim is proximately caused by Apollo’s [*****].
8.3 Indemnification
Procedure. A party entitled to indemnification hereunder
shall provide the indemnifying Party with prompt written notice of
any claim, suit, action, demand, or judgment for which
indemnification is sought under this Agreement. The indemnifying
Party shall, at its own expense, provide attorneys reasonably
acceptable to the other Party to defend against any such claim. The
indemnified Party shall cooperate fully with the indemnifying Party
in such defense and shall permit the indemnifying Party to conduct
and control such defense and the disposition of such claim, suit,
or action (including all decisions relative to litigation, appeal,
and settlement).
8.4 Insurance.
Within [*****] after the
Effective Date, Apollo shall obtain and carry in full force and
effect commercial general liability insurance, including, without
limitation, product liability and errors and omissions insurance
which shall protect Apollo and VistaGen Indemnitees with respect to
events covered by Section 8.1.
The limits of such insurance shall be customary and reasonable in
Apollo’s industry. At the request of VistaGen, Apollo shall
provide VistaGen with Certificates of Insurance evidencing
compliance with this Section 8.4.
Apollo shall continue to maintain such insurance after the
expiration or termination of this Agreement during any period in
which Apollo or any Affiliate or Sublicensee continues to make,
use, or sell a product that was a Licensed Product under this
Agreement, [*****].
ARTICLE 9
9.1 Mutual
Representations. Each Party represents and warrants to the
other that (i) such Party is a company or corporation duly
organized, validly existing and in good standing under the laws of
the jurisdiction in which it is organized; (ii) such Party has the
legal power and authority to execute, deliver and perform this
Agreement; (iii) the execution, delivery and performance by such
Party of this Agreement has been duly authorized by all necessary
corporate action; (iv) this Agreement constitutes the legal, valid
and binding obligation of such Party, enforceable against such
Party in accordance with its terms; and (v) the execution, delivery
and performance of this Agreement shall not cause or result in a
violation of any law, of such Party’s charter documents, or
of any contract by which such Party is bound.
___________________
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|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
-17-
Exclusive License and Sublicense Agreement
9.2 VistaGen
Representations, Warranties and Covenants. VistaGen
represents, warrants and covenants that:
(a) it
has, or will have (with respect to Future Improvements), the power
and authority to grant the licenses and sublicenses provided for
herein to Apollo, and that it has not earlier granted, or assumed
any obligation to grant, any rights in the Licensed IP or
Improvements to any third party that would conflict with the rights
granted to Apollo herein;
(b) it
has obtained from UHN the exclusive right to grant sublicenses
(including exclusive sublicenses) under the Licensed
IP;
(c) as
of the Effective Date, neither UHN nor VistaGen is in breach of any
License Agreement, nor has VistaGen received any notification from
UHN alleging it is in breach of any License Agreement;
(d) during
the Term, in the event that it (i) receives formal written notice
from UHN of a material breach of its obligations under any License
Agreement or (ii) sends formal written notice to UHN of a material
breach of UHN’s obligations under any License Agreement, in
each of (i) and (ii), it shall promptly provide Apollo a copy of
any such written notice;
(e) as
of the Effective Date, to its knowledge, there are no actions,
suits, investigations, claims or proceedings pending or threatened
in writing relating to the Licensed IP or
Improvements;
(f) as
of the Effective Date, VistaGen has not received any written notice
from UHN or any third party with respect to any actions, suits,
investigations, claims or proceedings pending or threatened in
writing relating to the Licensed IP or Improvements;
(g) other
than the License Agreements and the VistaGen SRA, it does not
license or does not have the right to license from UHN any other
patent rights or other intellectual property applicable to the
Apollo Field of Use;
(h) during
the Term, VistaGen shall not breach or default under any provision
of each License Agreement; and
(i) during
the Term and thereafter, VistaGen shall not amend or modify any
License Agreement in any manner without the prior written consent
of Apollo.
9.3 Disclaimer
of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER WARRANTIES CONCERNING
LICENSED IP, IMPROVEMENTS OR ANY OTHER MATTER WHATSOEVER,
INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT
OF THIRD PARTY RIGHTS OR ARISING OUT OF COURSE OF CONDUCT OR TRADE
CUSTOM OR USAGE, AND EACH PARTY DISCLAIMS ALL SUCH EXPRESS OR
IMPLIED WARRANTIES. VISTAGEN MAKES NO WARRANTY OR REPRESENTATION AS
TO THE VALIDITY OR SCOPE OF UHN PATENT RIGHTS OR IMPROVEMENT PATENT
RIGHTS, OR THAT ANY LICENSED PRODUCT SHALL BE FREE FROM AN
INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES. FURTHER, VISTAGEN HAS MADE NO INVESTIGATION AND
MAKES NO REPRESENTATION THAT THE UHN PATENT RIGHTS OR IMPROVEMENT
PATENT RIGHTS ARE SUITABLE FOR APOLLO’S
PURPOSES.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
9.4 Limitation
of Liability. EXCEPT FOR [*****], IN NO EVENT SHALL EITHER PARTY BE
LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR
CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR
LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES)
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT
MATTER. EACH PARTY’S AGGREGATE LIABILITY, IF ANY, FOR ALL
DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT
MATTER SHALL NOT EXCEED THE AMOUNT PAID BY APOLLO TO VISTAGEN UNDER
THIS AGREEMENT. THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL
APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND AND ON ANY THEORY OF
LIABILITY, WHETHER BASED ON CONTRACT, TORT (INCLUDING, WITHOUT
LIMITATION, NEGLIGENCE OR STRICT LIABILITY), OR ANY OTHER GROUNDS,
AND REGARDLESS OF WHETHER THE PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF
ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. THE PARTIES FURTHER AGREE
THAT EACH WARRANTY DISCLAIMER, EXCLUSION OF DAMAGES OR OTHER
LIMITATION OF LIABILITY HEREIN IS INTENDED TO BE SEVERABLE AND
INDEPENDENT OF THE OTHER PROVISIONS SINCE THEY EACH REPRESENT
SEPARATE ELEMENTS OF RISK ALLOCATION BETWEEN THE
PARTIES.
9.5 Breach
by VistaGen. In the event that VistaGen commits a breach of
any License Agreement and Apollo receives notice of such breach,
within [*****] of the receipt
of any such notice of breach, subject to any cure period permitted
under the applicable License Agreement, Apollo may request to meet
with UHN and VistaGen and representatives of the Parties shall meet
and discuss in good faith a potential cure of such breach in
accordance with the terms of the applicable License Agreement. In
the event VistaGen is unable to cure such breach, VistaGen hereby
provides Apollo (or any of its Affiliates or Sublicensees) the
right, but not the obligation, to cure such breach directly with
UHN on VistaGen’s behalf in accordance with the terms of the
applicable License Agreement. VistaGen shall reimburse Apollo (or
any of its Affiliates or Sublicensees) for any and all costs and
expenses incurred in attempting to cure, or curing, such breach. In
the event such breach is unable to be cured or is not cured
(including because Apollo does not elect to cure such breach), at
Apollo’s request, VistaGen shall use all reasonable efforts
to assist Apollo in entering into a direct license with UHN equal
in scope to the sublicense set forth in Article 2, [*****]. VistaGen further agrees not to
impede, restrict or otherwise interfere with the entrance of Apollo
and UHN into such direct license.
9.6 Breach
by UHN. In the event that UHN commits a material breach of
any License Agreement and such License Agreement is terminated as a
result of such breach, VistaGen shall delegate to Apollo, or pursue
at Apollo’s written request and expense, any cause of action
that VistaGen may have pursuant to the terms of the applicable
License Agreement.
ARTICLE 10
ASSIGNMENT
This
Agreement, and the rights and obligations hereunder, may not be
assigned or transferred, in whole or in part, by either Party
without the prior written consent of the other Party, except that
no consent shall be required for either Party to assign this
Agreement to (i) any entity acquiring it or all or substantially
all of the assets of such Party as to which this Agreement relates
whether by sale, merger, operation of law or otherwise (including,
for clarity, with respect to VistaGen all of the License
Agreements), or (ii) any of its Affiliates; provided that upon any
such assignment with respect to VistaGen, VistaGen shall similarly
assign each License Agreement and that certain letter agreement by
and among UHN, Apollo and VistaGen effective as of the date hereof
(the “Letter
Agreement”) such that the VistaGen contracting party
in each License Agreement and the Letter Agreement is the same
VistaGen contracting party as in this Agreement. Each Party shall
notify the other Party no later than [*****] after any assignment
of this Agreement. Any assignment in circumvention of the foregoing
shall be void. Subject to the foregoing, this Agreement shall be
binding upon and inure to the benefit of the Parties hereto and
their respective permitted successors and assigns.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
ARTICLE 11
GENERAL
COMPLIANCE WITH LAW
11.1 Compliance
with Laws. Apollo shall use
reasonable commercial efforts to comply with all commercially
material local, state, federal, and international laws and
regulations relating to the development, manufacture, use, and sale
of Licensed Products.
11.2 Export
Control. Apollo and its
Affiliates and Sublicensees shall comply with all United States
laws and regulations controlling the export of certain commodities
and technical data, including, without limitation, all Export
Administration Regulations of the United States Department of
Commerce. Among other things, these laws and regulations prohibit
or require a license for the export of certain types of commodities
and technical data to specified countries. Apollo hereby gives
written assurance that it shall comply with, and shall cause its
Affiliates and Sublicensees to comply with, all United States
export control laws and regulations, that it bears sole
responsibility for any violation of such laws and regulations by
itself or its Affiliates or Sublicensees, and that it shall
indemnify, defend, and hold VistaGen harmless (in accordance with
Section 8.1) for the consequences of
any such violation.
11.3 Marking
of Licensed Products. To the extent
commercially feasible and consistent with prevailing business
practices, Apollo shall xxxx, and shall cause its Affiliates and
Sublicensees to xxxx, all Licensed Products that are manufactured
or sold under this Agreement with the number of each issued patent
under the UHN Patent Rights or Improvement Patent Rights that
applies to such Licensed Product.
ARTICLE 12
12.1 Term.
Unless earlier terminated in accordance with the provisions of this
Article 12, this Agreement shall
continue in force on a country-by-country and Licensed
Product-by-Licensed Product basis until the expiration of the last
to expire patent within the UHN Patent Rights or Improvement Patent
Rights (the “Term”). Following the end
of the Term for any such Licensed Product in such country by
expiration (but not termination), the licenses granted to Apollo
under Sections 2.1(a)-(c) will become perpetual, irrevocable,
non-terminable, fully paid-up and royalty-free.
12.2 Voluntary
Termination by Apollo.
(a) Apollo
shall have the right to terminate this Agreement, for any reason,
upon at least [*****] prior
written notice to VistaGen, such notice to state the date at least
[*****] in the future upon
which termination is to be effective.
(b) Apollo
shall have the right to terminate this Agreement immediately upon
written notice to VistaGen on a Licensed IP-by-Licensed IP, UHN
Patent Right-by-UHN Patent Right, Improvement-by-Improvement or
Improvement Patent Right-by-Improvement Patent Right basis, such
notice to state the Licensed IP, UHN Patent Right, Improvement or
Improvement Patent Right for which such termination shall be
applicable (such terminated patent right or other intellectual
property, the “Terminated IP”). In the
event Apollo provides such notice, the Terminated IP will no longer
be subject to this Agreement, all licenses or sublicenses to such
Terminated IP will terminate and Apollo shall have no further
rights or obligations with respect to such Terminated IP as of the
date of VistaGen’s receipt of such written
notice.
12.3 Termination
for Breach .
(a) In
the event Apollo commits a material breach of its obligations under
this Agreement, and fails to cure that breach within [*****] after receiving written notice
thereof, VistaGen may terminate this Agreement immediately upon
written notice to Apollo, subject to completion of the dispute
resolution process set forth in Article
13 and subsequent cure. Notwithstanding the foregoing, if
VistaGen terminates this Agreement due to Apollo’s failure to
timely pay the sublicense and license issue fee required in Section
4.1(a), the termination is effective upon notice and the dispute
resolution process set forth in Article 13 shall not apply to such
termination.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
(b) In
the event VistaGen commits a material breach of its obligations
under this Agreement, Apollo may, in its discretion, either (i)
terminate this Agreement if VistaGen has not cured such breach
within [*****] after receipt
of written notice thereof or (ii) continue this Agreement and seek
arbitration pursuant to Article 13
confirming that such breach has in fact occurred and/or seeking
specific performance, and if such arbitration finds that such
breach indeed has occurred, then any future payments to VistaGen
pursuant to Article 4 of this
Agreement shall be reduced by [*****] as of the termination
date.
12.4 Other
Grounds for Bankruptcy. A Party may terminate this Agreement
immediately if the other Party hereto is declared insolvent or
commits an act of bankruptcy.
(a) Survival.
The following provisions shall survive the expiration or
termination of this Agreement: Article
1, Article 8, Article 9, Article
13 and Article 14, and
Sections 4.1(f), 5.2 (but only with respect to obligation to
provide final report and payment), 5.3, 11.1,
11.2, 12.1 (but only with respect to the second
sentence) and 12.5.
(b) Inventory.
Upon the early termination of this Agreement, Apollo and its
Affiliates and Sublicensees may complete and sell any
work-in-progress and inventory of Licensed Products that exist as
of the effective date of termination, provided that (i) Apollo
pays VistaGen the applicable running royalty or other amounts due
on Net Sales of any Revenue Bearing Products in accordance with the
terms and conditions of this Agreement, and (ii) Apollo and
its Affiliates and Sublicensees shall complete and sell all
work-in-progress and inventory of Licensed Products after the
effective date of termination.
(c) Expiration
or termination of this Agreement for any reason shall not relieve
either Party of any liability or obligation which accrued hereunder
prior to the effective date of such termination or
expiration.
ARTICLE 13
13.1 Mandatory
Procedures. The Parties agree
that any dispute arising out of or relating to this Agreement shall
be resolved solely by means of the procedures set forth in this
Article 13, and that such procedures
constitute legally binding obligations that are an essential
provision of this Agreement. If either Party fails to observe the
procedures of this Article 13, as may
be modified by their written agreement, the other Party may bring
an action for specific performance of these procedures in any court
of competent jurisdiction.
13.2 Equitable
Remedies. Although the
procedures specified in this Article
13 are the sole and exclusive procedures for the resolution of
disputes arising out of or relating to this Agreement, either Party
may seek a preliminary injunction or other provisional equitable
relief if, in its reasonable judgment, such action is necessary to
avoid irreparable harm to itself or to preserve its rights under
this Agreement.
13.3 Dispute
Resolution Procedures. Any controversy
or claim arising out of or relating to this Agreement, or the
breach thereof, shall be settled by binding confidential
arbitration in accordance with the Commercial Arbitration Rules
(the “Rules”) of the American
Arbitration Association (“AAA”), and the procedures
set forth below. In the event of any inconsistency between the
Rules of AAA and the procedures set forth below, the procedures set
forth below shall control. Judgment upon the award rendered by the
arbitrators may be enforced in any court having jurisdiction
thereof.
(a) The
location of the arbitration shall be in the County of New York.
VistaGen and Apollo hereby irrevocably submit to the exclusive
jurisdiction and venue of the AAA arbitration panel selected by the
Parties and located in New York, New York for any dispute regarding
this Agreement, and to the exclusive jurisdiction and venue of the
federal and state courts located in New York, New York for any
action or proceeding to enforce an arbitration award or as
otherwise provided in Section 13.3(e), and
waive any right to contest or otherwise object to such jurisdiction
or venue.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
(b) The
arbitration shall be conducted by a panel of three neutral
arbitrators who are independent and disinterested with respect to
the Parties, this Agreement, and the outcome of the arbitration.
Each Party shall appoint one neutral arbitrator, and these two
arbitrators so selected by the Parties shall then select the third
arbitrator, and all arbitrators must have at least ten (10)
years’ experience in mediating or arbitrating cases regarding
the same or substantially similar subject matter as the dispute
between VistaGen and Apollo. If one Party has given written notice
to the other Party as to the identity of the arbitrator appointed
by the Party, and the Party thereafter makes a written demand on
the other Party to appoint its designated arbitrator within the
next ten days, and the other Party fails to appoint its designated
arbitrator within ten days after receiving said written demand,
then the arbitrator who has already been designated shall appoint
the other two arbitrators.
(c) The
arbitrators shall decide any disputes and shall control the process
concerning these pre-hearing discovery matters. Pursuant to the
Rules of AAA, the Parties may subpoena witnesses and documents for
presentation at the hearing.
(d) Prompt
resolution of any dispute is important to both Parties; and the
Parties agree that the arbitration of any dispute shall be
conducted expeditiously. The arbitrators are instructed and
directed to assume case management initiative and control over the
arbitration process (including, without limitation, scheduling of
events, pre-hearing discovery and activities, and the conduct of
the hearing), in order to complete the arbitration as expeditiously
as is reasonably practical for obtaining a just resolution of the
dispute.
(e) The
arbitrators may grant any legal or equitable remedy or relief that
the arbitrators deem just and equitable, to the same extent that
remedies or relief could be granted by a state or federal court,
provided however, that no punitive damages may be awarded. No court
action shall be maintained seeking punitive damages. The decision
of any two of the three arbitrators appointed shall be binding upon
the Parties. Notwithstanding anything to the contrary in this
Agreement, prior to or while an arbitration proceeding is pending,
either Party has the right to seek and obtain injunctive and other
equitable relief from a court of competent jurisdiction to enforce
that Party’s rights hereunder.
(f) The
expenses of the arbitration, including, without limitation, the
arbitrators’ fees, expert witness fees, and attorney’s
fees, may be awarded to the prevailing Party, in the discretion of
the arbitrators, or may be apportioned between the Parties in any
manner deemed appropriate by the arbitrators. Unless and until the
arbitrators decide that one Party is to pay for all (or a share) of
such expenses, both Parties shall share equally in the payment of
the arbitrators’ fees as and when billed by the
arbitrators.
(g) Notwithstanding
the foregoing, any disputes arising hereunder with respect to the
inventorship, validity, enforceability or other aspect of
intellectual property rights shall be resolved by a court of
competent jurisdiction and not by arbitration.
(h) Except
as set forth below and as necessary to obtain or enforce a judgment
upon any arbitration award, the Parties shall keep confidential the
fact of the arbitration, the dispute being arbitrated, and the
decision of the arbitrators. Notwithstanding the foregoing, the
Parties may disclose information about the arbitration to persons
who have a need to know, such as directors, trustees, management
employees, witnesses, experts, investors, attorneys, lenders,
insurers, actual or potential collaborators or corporate partners
of Apollo, actual or potential acquirors of Apollo, and others who
may be directly affected provided that such persons are bound to
keep such information confidential. Additionally, if a Party has
stock which is publicly traded, the Party may make such disclosures
as are required by applicable securities laws, but shall use
commercially reasonably efforts to seek confidential treatment for
such disclosure.
13.4 Performance
to Continue. Each Party shall
continue to perform its undisputed obligations under this Agreement
pending final resolution of any dispute arising out of or relating
to this Agreement; provided, however, that a Party may suspend
performance of its undisputed obligations during any period in
which the other Party fails or refuses to perform its undisputed
obligations.
13.5 Statute
of Limitations. The Parties agree
that all applicable statutes of limitation and time-based defenses
(such as estoppel and laches) shall be tolled while the procedures
set forth in Section 13.5 are pending.
The Parties shall cooperate in taking any actions necessary to
achieve this result.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
ARTICLE 14
14.1 Notice.
Any notices required or permitted under this Agreement shall be in
writing, shall specifically refer to this Agreement, and shall be
sent by hand, recognized national overnight courier, confirmed
facsimile transmission, confirmed electronic mail, or registered or
certified mail, postage prepaid, return receipt requested, to the
following addresses or facsimile numbers of the
Parties:
If to
VistaGen:
VistaGen
Therapeutics, Inc.
000
Xxxxxxxx Xxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attention: Xxxxx X.
Xxxxx, CEO
If to
Apollo:
Apollo
Biologics LP
c/o
Versant Venture Management, LLC
Xxx
Xxxxxxx
Xxxxx
0000
Xxx
Xxxxxxxxx, XX 00000
Attention: Xxxxx
Xxxxx, Authorized Representative
All
notices under this Agreement shall be deemed effective upon
receipt. A Party may change its contact information immediately
upon written notice to the other Party in the manner provided in
this Section 14.1.
14.2 Governing
Law. This Agreement
and all disputes arising out of or related to this Agreement, or
the performance, enforcement, breach or termination hereof, and any
remedies relating thereto, shall be construed, governed,
interpreted and applied in accordance with the laws of the State of
Delaware, without regard to conflict of laws principles, except
that questions affecting the construction and effect of any patent
shall be determined by the law of the country in which the patent
shall have been granted.
14.3 Force
Majeure. Neither Party
shall be responsible for delays resulting from causes beyond the
reasonable control of such Party, including, without limitation
fire, explosion, flood, war, strike, or riot, provided that the
nonperforming Party uses commercially reasonable efforts to avoid
or remove such causes of nonperformance and continues performance
under this Agreement with reasonable dispatch whenever such causes
are removed.
14.4 Amendment
and Waiver. This Agreement
may be amended, supplemented, or otherwise modified only by means
of a written instrument signed by both Parties. Any waiver of any
rights or failure to act in a specific instance shall relate only
to such instance and shall not be construed as an agreement to
waive any rights or fail to act in any other instance, whether or
not similar.
14.5 Severability.
In the event that any provision of this Agreement shall be held
invalid or unenforceable for any reason, such invalidity or
unenforceability shall not affect any other provision of this
Agreement, and the Parties shall negotiate in good faith to modify
this Agreement to preserve (to the extent possible) their original
intent. If the Parties fail to reach a modified agreement within
thirty (30) days after the relevant provision is held invalid or
unenforceable, then the dispute shall be resolved in accordance
with the procedures set forth in Article
13. While the dispute is pending resolution, this Agreement
shall be construed as if such provision were deleted by agreement
of the Parties.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
14.6 Binding
Effect. This Agreement
shall be binding upon and inure to the benefit of the Parties and
their respective legal representatives, successors and
assigns.
14.7 Headings.
All headings are for convenience only and shall not affect the
meaning of any provision of this Agreement.
14.8 Entire
Agreement. This Agreement
constitutes the entire agreement between the Parties with respect
to its subject matter and supersedes all prior agreements or
understandings between the parties relating to its subject
matter.
14.9 Construction.
The use of words in the singular or plural, or with a particular
gender, shall not limit the scope or exclude the application of any
provision of this Agreement to such person or persons or
circumstances as the context otherwise permits. The words
“will” and “shall” shall have the same
meaning and, unless the context otherwise requires, the use of the
word “or” is used in the inclusive sense (and/or). The
term “including, “include,” or
“includes” as used herein shall mean including, without
limiting the generality of any description preceding such term,
irrespective of whether such term is used “without
limitation” or “without limiting” throughout this
Agreement.
14.10
Counterparts. This
Agreement may be executed in counterparts signed separately by the
Parties, each of which together shall constitute one and the same
instrument. Execution of this Agreement may be concluded by signing
and delivery by electronic transmission to a Party of the other
Party’s signed copy.
[remainder
of this page intentionally left blank]
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives.
VISTAGEN
THERAPEUTICS, INC.
By:
/s/ Xxxxx X.
Xxxxx
Name:
Xxxxx X.
Xxxxx
Title:
Chief Executive
Officer
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
APOLLO
BIOLOGICS LP
By: BJD
Newco, LLC, its general partner
By:
/s/ Xxxxx
Xxxxx
Name:
Xxxxx
Xxxxx
Title:
Authorized
Representative
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
A
LICENSED
IP
License Agreement Number One:
License
Agreement Number 1, dated as of October 24, 2011, between UHN and
VistaGen
Licensed IP shall
mean all inventions described in U.S. Provisional Patent
Application Serial No. 61/377,665 and International Patent
Application Serial No. PCT/CA2011/000965 and any application for
Letters Patent claiming priority thereto and/or disclosing
inventions disclosed therein, and in and to any Letters Patent or
Patents in the United States of America and all foreign countries
which may be granted therefor and thereon, and in and to any and
all conversions, divisions, continuations, continuations-in-part of
said application, or reissues or extensions of said Letters Patent
or Patents, and all rights under the International Convention for
the Protection of Industrial Property.
License Agreement Number Two:
License
Agreement, dated as of December 22, 2014, between UHN and VistaGen,
[*****].
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
License Agreement Number Three:
License
Agreement, dated as of December 9, 2016, between UHN and VistaGen,
[*****].
License Agreement Number Four:
License
Agreement, dated as of December 9, 2016, between UHN and VistaGen,
[*****].
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE
A
LICENSE
AGREEMENT NUMBER ONE
(See
attached)
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE A
LICENSE
AGREEMENT NUMBER 1
dated
as of October 24, 2011
between
UNIVERSITY
HEALTH NETWORK (as "Licensor")
and
VISTAGEN
THERAPEUTICS, INC. (as "Licensee")
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
1. DEFINITIONS
2. REPRESENTATIONS
AND WARRANTIES
2.1 Mutual
Representations and Warranties
2.2 Licensor
Representations and Warranties
3.
LICENSE GRANT
3.1 Licensed
IP
3.2 Availability
of the Licensed IP
3.3 Reserved
Right
4.
FINANCIAL CONSIDERATIONS
4.1 Development-Based
Milestone Payments
4.2 Royalties
5.
ROYALTY REPORTS, PAYMENTS, AND ACCOUNTING
5.1 Royalty
Reports
5.2 Payment
Terms
5.3 Audits
6.
RESEARCH AND DEVELOPMENT OBLIGATIONS
6.1 Research
and Development Efforts
6.2 R&D
Plan
6.3 Records
6.4 Reports
7.
CONFIDENTIALITY
7.1 Confidential
Information
7.2 Terms
of this Agreement
8.
PATENTS
8.1 Patent
Prosecution and Maintenance
8.2 Notification
of Infringement
8.3 Enforcement
of Patent Rights
8.4 Cooperation
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
9.
TERMINATION
9.1 Expiration
9.2 Termination
by Mutual Consent
9.3 Termination
by Licensee
9.4 Termination
for Cause
9.5 Termination
Upon Licensee Insolvency
9.6 Effect
of Expiration or Termination
10.
INDEMNIFICATION
10.1 Indemnification
10.2 Procedure
10.3 Insurance
10.4 Certificates
of Insurance
10.5 Notice
of Cancellation or Expiration
11. FORCE
MAJEURE
12. GENERAL
PROVISIONS
12.1 Notices
12.2 Further
Representations, Warranties & Liability
12.3 Dispute
Resolution
12.4 Assignee
12.5 Waivers
and Amendments
12.6 Entire
Agreement
12.7 Severability
12.8 Waiver
12.9 Counterparts
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
LICENSE
AGREEMENT
THIS
LICENSE AGREEMENT NUMBER 1 (this "Agreement") is dated as of
October 24, 201.1 (the "Effective Date"), and is
entered into by and between (i) University Health Network, an
Ontario corporation, incorporated under the Xxxxxxx Xxxxxxxx Xxx
0000 ("Licensor"),
having a research office at 000 Xxxxxxxxxx Xxxxxx, Xxxxx 0-000,
Xxxxxxx, Xxxxxxx, Xxxxxx X0X0X0, and (ii)VistaGen Therapeutics,
Inc., a Nevada corporation ("Licensee"), having a place of
business at 000 Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 0, Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000.
WHEREAS, Licensor
owns or has rights in the Licensed IP (as defined in Exhibit
B).
WHEREAS, Licensee
desires to obtain an exclusive license under Licensor's rights in
the Technology on the terms and conditions set forth
below.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:
1. DEFINITIONS
For purposes of this Agreement, the terms defined in Exhibit A
shall have the defined meanings set forth in Exhibit A. Unless
otherwise noted, all dollar amounts are quoted in US
dollars.
2. REPRESENTATIONS
AND WARRANTIES
2.1 Mutual Representations and
Warranties. Each Party hereby represents and warrants to the
other Party as follows:
2.1.1 Such
Party is a corporation duly organized, validly existing and in good
standing under the laws of the state, province or country in which
it is incorporated.
2.1.2 Such
Party (a) has the corporate power and authority and the legal right
to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate action on its
part to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms.
2.1.3 All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such Party in connection with this Agreement have been
obtained.
2.1.4 The
execution and delivery of this Agreement and the performance of
such Party's obligations hereunder (a) do not conflict with or
violate any requirement of applicable laws or regulations, and (b)
do not conflict with, or constitute a default under, any
contractual obligation of it.
2.2 Licensor Representations and
Warranties. Licensor hereby represents and warrants to
Licensee that, as of the Effective Date, Licensor, to the best of
its knowledge, (a) is the sole owner of the Licensed IP, and (b)
other than as noted in Exhibit C, has not granted to any Third
Party any license or other interest in the Licensed IP, and (c) is
not aware of any Third Party patent, patent application or other
intellectual property rights (other than any inventions identified
as prior art in the patents or patent applications licensed to
Licensee hereunder) that would be infringed (i) by practicing any
process or method or by making, using or selling any composition
which is claimed or disclosed in the Licensed IP, or (ii) by
making, using or selling Licensed Products (but only to the extent
that the making, using or selling of Licensed Products is covered
by Licensed IP), and (d) is not aware of any infringement or
misappropriation by a Third Party of the Licensed IP.
Notwithstanding the foregoing, Licensor is under no duty,
obligation or requirement to perform or conduct any legal inquiry
or other search, analyses or assessment pertaining to
patentability, validity, infringement and/or legal status in
respect of any Licensed IP and Licensed Patents.
3. LICENSE
GRANT
3.1 Licensed
IP. Subject to Section 3.3, Licensor hereby grants to
Licensee an exclusive license (with the right to grant sublicenses
through multiple tiers) under the Licensed IP to conduct research
and to develop, make, have made, use, offer for sale, sell and
import Licensed Products, worldwide and for all fields of use.
Licensee shall promptly provide to Licensor a copy of any
Sublicense Agreement. The grant of any such Sublicense Agreement
will not relieve Licensee of its obligations under this
Agreement.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
3.2 Availability
of the Licensed IP. Within ten (10) days of the Effective
Date, Licensor shall provide Licensee with a copy of all
information and documents available to Licensor relating to the
filing and prosecution of patent applications encompassing the
Licensed IP.
3.3 Reserved
Right. Licensor reserves and retains the non-exclusive,
sublicenseable right to use the Licensed IP for non-commercial
research purposes and/or academic educational purposes, without any
financial obligation to Licensee for so using the Licensed
IP.
4. FINANCIAL
CONSIDERATIONS
4.1 Development-Based Milestone
Payments. At such time as Licensee (or its Affiliates or
Sublicensees) achieve a Milestone Event as described below for a
specific Licensed Product, Licensee shall pay to Licensor the
Milestone Payment specified below. The specified milestone payment
shall be made within thirty (30) days after the occurrence of the
Milestone Event.
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A.
"Milestone
Event" for Therapeutic-Related Licensed
Product *
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"Milestone Payment"
(US$)
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(1)
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Acceptance
by FDA (first country) of filing of IND
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$150,000
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(2)
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First
patient enrolled for Phase II Clinical Trial
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$250,000
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(3)
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First
patient enrolled for Phase HI Clinical Trial
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$1,500,000
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(4)
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FDA
(First country) Final Approval of NDA for Licensed
Product
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$2,000,000
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B.
"Milestone Event" for Service-Related
Licensed Product
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"Milestone Payment"
(US$)
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(1)
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First
anniversary of execution of an agreement in respect of (in whole or
in part) a Service-Related Licensed Product
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$50,000
**
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For the purpose of this Section 4.1 "Final Approval" shall mean
approval by the FDA for marketing a Therapeutic-Related Licensed
Product that is not conditioned on any other event (or if an
approval is conditioned upon an event, then the occurrence of that
event), provided, however, such other events shall specifically not
include FDA requirements to conduct post marketing studies and any
requirement for such post marketing studies shall not be deemed to
delay the Final Approval.
* Once
a Milestone Payment has been made for a specific Licensed Product,
if there are later modifications, improvements, reformulations,
combinations, or other changes using the same molecule which
constitutes said Licensed Product (i.e., a "Related Product"), then no
duplicate Milestone Payment will be owed when that Related Product
achieves the same Milestone Event for which the Milestone Payment
was previously made for said specific Licensed Product. Similarly,
if there is a failure in product development, resulting in the
substitution or replacement of the failed molecule with a new
molecule, to the extent that a Milestone Event had previously been
achieved by the failed molecule and the corresponding Milestone
Payment paid, then no duplicate Milestone Payment will be owed when
the new molecule achieves the same Milestone Event for which the
Milestone Payment was previously made for the failed
molecule.
**
But not more than 10% of the annual revenues received from said
agreement, continuing annually until the cumulative aggregate of
said 10% payments reach $50,000.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
4.2 Royalties.
4.2.1 Royalty Rate. Licensee shall
pay to Licensor three percent (3%) of the first $25 million of
Revenues received by Licensee or its Affiliates, and two percent
(2%) of all additional Revenues received by Licensee or its
Affiliates, subject to reductions pursuant to Sections 4.2.2 and
4.2.3.
4.2.2 Third
Party Royalties. If Licensee or its Affiliates is required
to pay royalties to any Third Party that are, in the opinion of an
independent patent attorney (reasonably acceptable to both
parties), necessary to practice the inventions claimed in the
Licensed IP, then Licensee shall have the right to credit such
Third Party royalty payments against the royalties owing to
Licensor under Section 4.2.1; provided, however, that the
foregoing credits shall not reduce the amount of the royalties
payable to Licensor under Section 4.2.1 above by more than fifty
percent (50%).
4.2.3 Combination
Products. If a Product consists of (i) components that are
covered by Licensor's Valid Claims, plus (ii) additional active
pharmaceutical agents, or functional components reasonable
necessary for formulation or delivery of the Product that are not
covered by a Valid Claim, but that are covered by a valid claim of
a Third Party patent, then for purposes of the royalty payments
under Section 4.2.1, the Revenues shall be equitably allocated
between the components covered by Licensor's Valid Claim and the
components covered by the Third Party patent, with only the portion
of Revenues allocated to Licensor's Valid Claims being used for
purposes of the royalty calculation in Section 4.2.1 for such
combination Product. To the extent the parties are unable to agree
on the equitable allocation described above, any dispute shall be
resolved in accordance with Section 12.3 of this Agreement.
Notwithstanding the aforementioned, the foregoing allocation shall
not reduce the amount of the royalties payable to Licensor under
Section 4.2.1 above by more than fifty percent (50%).
5. ROYALTY
REPORTS. PAYMENTS. AND ACCOUNTING
5.1 Royalty
Reports. Within sixty (60) days after the end of each
calendar quarter during the term of this Agreement following the
receipt by Licensee or its Affiliates of Revenues, Licensee shall
furnish to Licensor a quarterly written report showing in
reasonably specific detail (a) the calculation of Revenues for such
quarter; and (b) the calculation of the royalties that shall have
accrued based upon such Revenues.
5.2 Payment
Terms. Royalties shown to have accrued by each royalty
report provided for under Section 5.1 above shall be due on the
date such royalty report is due.
5.3 Audits.
5.3.1 Upon the written request of Licensor and not
more than once in each calendar year, Licensee and its Affiliates
shall permit an independent certified public accounting firm of
nationally recognized standing selected by Licensor and reasonably
acceptable to Licensee, at Licensor's expense, to have access
during normal business hours to such of the financial records of
Licensee and its Affiliates as may be reasonably necessary to
verify the accuracy of the payment reports hereunder for the eight
(8) calendar quarters immediately prior to the date of such request
(other than records for which Licensor has already conducted an
audit under this Section).
5.3.2 If such
accounting firm concludes that additional amounts were owed during
the audited period, Licensee shall pay such additional amounts
within thirty (30) days after the date Licensor delivers to
Licensee such accounting firm's written report so concluding. The
fees charged by such accounting firm shall be paid by Licensor;
provided, however, if the audit discloses that the royalties paid
by Licensee for such period were more than seven percent (7%) below
the royalties actually due and payable for such period, then
Licensee shall pay the reasonable fees and expenses charged by such
accounting firm.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
5.3.3 Licensor
shall cause its accounting firm to retain all financial information
subject to review under this Section 5.3 in strict confidence;
provided, however, that Licensee shall have the right to require
that such accounting firm, prior to conducting such audit, enter
into an appropriate non-disclosure agreement with Licensee
regarding such financial information. The accounting firm shall
disclose to Licensor only whether the reports are correct or not
and the amount of any discrepancy. No other information shall be
shared. Licensor shall treat all such financial information as
Licensee's Confidential Information
6. RESEARCH
AND DEVELOPMENT OBLIGATIONS
6.1 Research
and Development Efforts. Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to conduct such research, development and preclinical and
human clinical trials as Licensee reasonably determines are
necessary or desirable to obtain regulatory approval to manufacture
and market such Licensed Products as Licensee reasonably determines
are commercially feasible; and Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to obtain regulatory approval to market, and following
approval to commence marketing and to market each such Licensed
Product as Licensee reasonably determines are commercially
feasible.
6.2 R&D
Plan. Within three (3) months after the Effective Date,
Licensee shall furnish to Licensor a copy of Licensee's Research
and Development Plan ("R&D Plan") for Licensed
Products; and a status and progress report as to Licensee's
implementation of the R&D Plan shall be furnished to Licensor
annually thereafter, together with an update for the R&D Plan
for the next year. The parties acknowledge that the R&D Plan
will represent the optimal and desired goals and timeline for
development of the Licensed Products, and that there is no
guarantee of achieving the goals within said timeline.
6.3 Records.
Licensee shall maintain records, in sufficient detail and in good
scientific manner, which shall reflect all work done and results
achieved in the performance of its research and development
regarding the Licensed Products.
6.4 Reports.
By April 1 of each calendar year during the term of this Agreement,
Licensee shall prepare and deliver to Licensor a written summary
report which shall describe (a) the research performed to date
employing the Licensed IP, (b) the progress of the development, and
testing of Licensed Products in clinical trials, and (c) the status
of obtaining regulatory approvals to market Licensed
Products.
7. CONFIDENTIALITY
7.1 Confidential
Information. The reports finished by Licensee to Licensor
pursuant to Sections 4, 5 and 6 shall be treated as Licensee's
Confidential Information. During the term of this Agreement, and
for a period of five (5) years following the expiration or earlier
termination hereof, Licensor shall maintain in confidence all
Confidential Information of Licensee that is disclosed to Licensor,
and shall not use, disclose or grant the use of the Confidential
Information except on a need-to-know basis to those directors,
officers, employees and agents, to the extent such disclosure is
reasonably necessary in connection with exercising its rights under
this Agreement.
7.2 Terms
of this Agreement. Except as otherwise required by
applicable laws, Licensor and Licensee shall not disclose any terms
or conditions of this Agreement to any Third Party without the
prior consent of the other Party. Notwithstanding the foregoing,
Licensor may disclose the existence of this Agreement and the
general nature of the Licensed IP covered by this Agreement
(without disclosing any financial terms); and Licensee may disclose
the term of this Agreement to any existing or prospective investor
or business associate who has a need to know, subject to a
customary confidentiality agreement.
8. PATENTS
8.1 Patent
Prosecution and Maintenance. Licensee shall have the right
to control, at its sole cost, the preparation, filing, prosecution,
defense in post-grant and/or post-issuance administrative
procedures, and maintenance of all patents and patent applications
in respect of Licensed Patents in the Territory and shall be solely
responsible for all costs incurred in the preparation, filing,
prosecution and maintenance of such patents and patent applications
from the Effective Date through the termination of this Agreement.
All such applications in respect of Licensed Patents shall be filed
in the name of Licensor. Licensee shall give Licensor an
opportunity to review and comment on the text of each patent
application subject to this Section 8.1 before filing, and shall
supply Licensor with a copy of such patent application as filed,
together with notice of its filing date and serial number. Licensor
shall cooperate with Licensee, execute all lawful papers and
instruments and make all rightful oaths and declarations as may be
necessary in the preparation, prosecution and maintenance of all
patents and other filings referred to in this Section 8.1. If
Licensee, in its sole discretion, decides to abandon the
preparation, filing, prosecution or maintenance of any patent or
patent application in respect of Licensed Patents, then Licensee
shall notify Licensor in writing thereof and following the date of
such notice (a) Licensor shall be responsible for and shall
control, at its sole cost, the preparation, filing, prosecution and
maintenance of such patents and patent applications,
and
(b)
Licensee shall thereafter have no license under this Agreement to
such patent or patent application.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
8.2 Notification
of Infringement, Each Party shall notify the other Party of
any substantial infringement known to such Party of any Licensed
Patents and shall provide the other Party with the available
evidence, if any, of such infringement.
8.3 Enforcement
of Patent Rights. Licensee, at its sole expense, shall have
the right to determine the appropriate course of action to enforce
Licensed Patents or otherwise xxxxx the infringement thereof,
to take (or refrain from taking) appropriate action to enforce
Licensed Patents, to defend any declaratory judgments seeking to
invalidate or hold the Licensed Patents unenforceable, to control
any litigation or other enforcement action and to enter into, or
permit, the settlement of any such litigation, declaratory
judgments or other enforcement action with respect to Licensed
Patents, in each case in Licensee's own name and, if necessary for
standing purposes, in the name of Licensor and shall consider, in
good faith, the interests of Licensor in so doing. If Licensee does
not, within six (6) months after receipt of notice from Licensor,
xxxxx the infringement or file suit to enforce the Licensed Patents
against at least one infringing Party, Licensor shall have the
right to take whatever action it deems appropriate to enforce the
Licensed Patents; provided, however, that, within thirty (30) days
after receipt of notice of Licensor's intent to file such suit,
Licensee shall have the right to jointly prosecute such suit and to
fund up to one-half the costs of such suit. The Party
controlling any such joint enforcement action shall not settle the
action or otherwise consent to an adverse judgment in such joint
action that diminishes the rights or interests of the
non-controlling Party without the prior written consent of the
other Party. All monies recovered upon the final judgment or
settlement of any such suit to enforce the Licensed Patents shall
be shared in relation to the damages (including attorneys' fees and
expenses for the enforcement action) incurred by each Party as a
result of such infringement; and such recovery shall not be treated
as Revenues for purposes of Section 4.2.1. Notwithstanding the
foregoing, to the extent any part of the recovery includes a
reasonable royalty payable to Licensee, such royalty amounts shall
be deemed Revenue on which Licensee will pay a royalty to Licensor
in accordance with Section 4.2.1.
8.4 Cooperation. In any suit to
enforce and/or defend the Licensed Patents pursuant to this Section
8, the Party not in control of such suit shall, at the request and
expense of the controlling Party, reasonably cooperate and, to the
extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples,
specimens, and the like.
9. TERMINATION
9.1 Expiration.
Subject to Sections 9.3 and 9.4 below, this Agreement shall expire
on the expiration of Licensee's obligation to make payments to
Licensor under Section 4 above. The license grant under Section 3.1
shall be effective at all times prior to such
expiration.
9.2 Termination
by Mutual Consent. The Parties may terminate this Agreement
at any time by mutual consent, which consent shall be evidenced by
a written agreement or other such documentation duly executed by
both Parties.
9.3 Termination
by Licensee. Licensee may terminate this Agreement, in its
sole discretion, upon thirty (30) days prior written notice to
Licensor, provided, however, Licensee shall remain liable for any
payments accrued under this Agreement prior to the date of
termination.
9.4 Termination
for Cause. Except as otherwise provided in Section 11,
Licensor may terminate this Agreement upon or after the breach of
any material provision of this Agreement by Licensee, if Licensee
has not cured such breach within ninety (90) days after receipt of
express written notice thereof by Licensor; provided, however, if
any default is not capable of being cured within such ninety (90)
day period and Licensee is diligently undertaking to cure such
default as soon as commercially feasible thereafter under the
circumstances, Licensor shall have no right to terminate this
Agreement.
9.5 Termination
Upon Licensee Insolvency. This Agreement shall terminate at least
one day prior to the occurrence of any of the following events: (i)
the Licensee files a voluntary petition in bankruptcy or insolvency
or shall petition for reorganization under the bankruptcy law, or
makes a general assignment for the benefit of creditors, or
otherwise acknowledges insolvency or is adjudged bankrupt; (ii) the
Licensee consents to an involuntary petition in bankruptcy or if a
receiving order is given against it under any applicable
bankruptcy/insolvency law in a jurisdiction; (iii) the appointment
of a receiver or other similar representative for the Licensee by a
court of competent jurisdiction; or (iv) Licensee fails to carry on
business in the normal course.
9.6 Effect
of Expiration or Termination. Expiration or termination of
this Agreement shall not relieve the Parties of any obligation
accruing prior to such expiration or termination, and the
provisions of Sections 1, 2, 5,7, 9.1, 9.6,10 and 12 shall survive
the expiration or termination of this Agreement. Upon any
termination of this Agreement, Licensor shall grant a direct
license to any sublicense of Licensee hereunder having the same
scope as such sublicense and on terms and conditions no less
favorable to such Sublicensee than the terms and conditions of this
Agreement, provided that such Sublicensee is not in default of any
applicable obligations under this Agreement and agrees in writing
to be bound by the terms and conditions of such direct license.
Upon any termination of this Agreement, for a period of six (6)
months thereafter, Licensee (and its Affiliates and Sublicensees)
shall continue to be entitled to finish production of any Products
which were in process at the time of termination, and Licensee (and
its Affiliates and Sublicensees) shall be entitled to sell all
Products which were in inventory or in process at the time of
termination, so long as Licensee (and its Affiliates and
Sublicensees) continues to make the reports and pay the scheduled
royalties for said sales as set forth in this
Agreement.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
10. INDEMNIFICATION
10.1 Indemnification.
Licensee shall defend, indemnify and hold Licensor (which for
purposes of clarity, is recognized to include, without limitation,
its directors, officers, employees, research trainees, students and
agents) harmless from all losses, liabilities, damages and expenses
(including attorneys' fees and costs) incurred as a result of any
claim, demand, action or proceeding arising out of any breach of
this Agreement by Licensee, any damages or personal injury
resulting from the use, application of, distribution, sale or other
exploitation of the Licensed IP, Licensed Patents and the Licensed
Product by Licensee, its Affiliates or Sublicensees, or the gross
negligence or willful misconduct of Licensee in the performance of
its obligations under this Agreement, except in each case to the
extent arising from the gross negligence or willful misconduct of
Licensor or the breach of this Agreement by Licensor.
10.2 Procedure.
Licensor promptly shall notify Licensee of any liability or action
in respect of which Licensor intends to claim such indemnification,
and Licensee shall have the right to assume the defense thereof
with counsel selected by Licensee. The indemnity agreement in this
Section 10 shall not apply to amounts paid in settlement of any
loss, claim, damage, liability or action if such settlement is
effected without the consent of Licensee, which consent shall not
be withheld unreasonably. The failure to deliver notice to Licensee
within a reasonable time after the commencement of any such action,
if prejudicial to its ability to defend such action, shall relieve
Licensee of any liability to Licensor under this Section 10, but
the omission so to deliver notice to Licensee will not relieve it
of any liability that it may have to Licensor otherwise than under
this Section 10. Licensor under this Section 10, its employees and
agents, shall cooperate fully with Licensee and its legal
representatives in the investigation and defense of any action,
claim or liability covered by this indemnification.
10.3 Insurance.
During the term of this Agreement, Licensee shall maintain
at its own expense:
10.3.1 Comprehensive
general liability insurance for claims for damages arising from
bodily injury (including death) and property damages caused by, or
arising out of, acts or omissions of its employees, in such amounts
as are customary and reasonable in the Licensee's
industry.
10.3.2 Product
liability insurance in such amounts as are customary and reasonable
in the Licensee's industry.
10.3.3 Maintenance
of such insurance coverage shall not relieve Licensee of any
responsibility under this Agreement for damage in excess of the
insurance limits.
10.4 Certificates
of Insurance. Licensee shall furnish or cause to be
furnished to Licensor a certificate of such insurance promptly upon
request by Licensor. Each such certificate shall name Licensor an
additional named insured.
10.5 Notice
of Cancellation or Expiration. Any such insurance
policy shall provide that the insurer will give Licensor at least
sixty (60) days prior written notice of any impending cancellation,
nonrenewal, expiration, or reduction in coverage of the
insurance.
11. FORCE
MAJEURE
Neither
Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from Force Majeure events.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12. GENERAL
PROVISIONS
12.1 Notices. Any consent, notice or
report required or permitted to be given or made under this
Agreement by one Party to the other Party shall be in writing,
delivered by any available means to such other Party at its address
indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor and shall be
effective upon receipt by the addressee.
If to
Licensor:
University Health
Network
000
Xxxxxxxxxx Xxxxxx Xxxxx 0-000
Xxxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
With
Copy to:
Director
University Health
Network
Office
of Technology Development & Commercialization
MaRS
Centre, Heritage Building 000 Xxxxxxx Xxxxxx, Xxxxx
000
Xxxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
If to
Licensee:
Chief
Executive Officer
VistaGen
Therapeutics, Inc.
000
Xxxxxx Xxxxx Xxxxxxxxx Xxxxx 0
Xxxxx
Xxx Xxxxxxxxx, XX 00000
With
Copy to:
Xxxxxx
Xxxxxx
Xxxxxxxx &
Xxxxxxxx LLP
000
Xxxx Xxxx Xxxx
Xxxx
Xxxx, XX 00000-0000
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12.2 Further
Representations, Warranties & Liability.
(a) Licensee
represents and warrants to Licensor that Licensee has
the power to enter into this Agreement and to perform its
obligations, and that Licensee has taken necessary action for the
execution of this Agreement to constitute a binding obligation
enforceable against Licensee.
(b) Licensor
represents and warrants to Licensee that Licensor has
the power to enter into this Agreement and to perform its
obligations, and that Licensor has taken necessary action for the
execution of this Agreement to constitute a binding obligation
enforceable against Licensor,
(c) EXCEPT
AS EXPRESSLY PROVIDED IN THIS AGREEMENT, LICENSOR MAKES NO
CONDITIONS, WARRANTEES, UNDERTAKINGS OF ANY KIND, INCLUDING WITHOUT
LIMITATION, THE ORIGINALITY OR ACCURACY OR PATENTABILITY OR
VALIDITY OR NONINFRINGEMENT OF THE LICENSED PATENT(S), LICENSED IP,
OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT
MATTER OF, THIS AGREEMENT OR THE OWNERSHIP, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE OF THE LICENSED PATENT(S),
LICENSED IP, OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE
SUBJECT MATTER OF THIS AGREEMENT.
(d) LICENSOR
SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, OR
OTHER DAMAGES SUFFERED BY LICENSEE (AND ITS AFFILIATE(S) AND
SUBLICENSEES) OR ANY OTHERS RESULTING FROM THE USE OF THE OF THE
LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S) ARISING
UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT. THE
ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, USE, EXPLOITATION,
MANUFACTURE, SALE OR OTHER DISPOSITION AND PERFORMANCE IN RESPECT
OF THE LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S)
ARISING UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT IS
ASSUMED BY LICENSEE.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12.3 Dispute
Resolution.
(a) The
Parties agree to use reasonable best efforts to amicably resolve
among themselves any dispute arising out of this
Agreement.
(b) If the
Parties are unable to resolve the dispute under Section 8.5(a), the
dispute shall be referred to the Vice President, Research of
Licensor or the Vice President's designate and the designate of
Licensee for their discussion and resolution. The Parties may agree
to mediation of the dispute (procedural details and process to be
determined by the Parties).
(c) Any
dispute which cannot be amicably settled by the Parties as provided
in Sections 8.5(a) and (b) shall be submitted to arbitration in
accordance with the provisions of the (Ontario) Arbitration Act,
1991, S.O. 1991, c. 17, as amended from time to time. The
arbitration will take place in the city of Toronto (Ontario,
Canada).
(d) Notwithstanding
the foregoing, either Party shall have the right, without waiving
any right or remedy available to such Party under this Agreement or
otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending
the selection of the mediator(s) or arbitrator(s) hereunder, or
pending the mediator(s)' or arbitrator(s)' determination of any
dispute, controversy or claim hereunder.
12.4 Assignment.
Licensee shall not assign its rights or obligations under this
Agreement without the prior written consent of
Licensor; provided, however, that Licensee may,
without such consent, assign this Agreement and its rights and
obligations hereunder (a) to any Affiliate, or (b) in connection
with the transfer or sale of all or substantially all of its
business to which this Agreement relates, or in the event of its
merger, consolidation, change in control or similar transaction.
Notwithstanding the aforementioned, Licensee shall remain
responsible for the performance of all obligations under this
Agreement (including, without limitation, the payment of royalties
to Licensor).
12.5 Waivers
and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions
herein contained, shall be valid unless made in writing and signed
by duly authorized representatives of the parties
hereto.
12.6 Entire
Agreement. This Agreement embodies the entire agreement
between the parties and supersedes any prior representations,
understandings and agreements between the parties regarding the
subject matter hereof. There are no representations, understandings
or agreements, oral or written, between the parties regarding the
subject matter hereof that are not fully expressed
herein.
12.7 Severability.
Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective
to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the
remaining provisions hereof and without affecting the validity or
enforceability of any of the terms of this Agreement in any other
jurisdiction.
12.8 Waiver.
The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or
otherwise.
12.9 Counterparts.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Evidence of the execution
and delivery of this Agreement may be by a telecopy transmission to
a Party of the other Party's signed copy of this
Agreement.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
IN
WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date.
LICENSORS
University of Health Network
By:/s/ Xxxxxxxxxxx X.
Xxxxx
Name:
Xxxxxxxxxxx X. Xxxxx, PhD
Title:
Vice President, Research
LICENSEE: VistaGen
Therapeutics, Inc.
By: Xxxxx
X. Xxxxx
Name:
Xxxxx X. Xxxxx
Title:
Chief Executive Officer
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
A
DEFINITIONS
"Affiliate"
shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
"Confidential Information" shall mean, with respect to
a Party, all information (and all tangible and intangible
embodiments thereof), that is owned or controlled by such Party, is
disclosed by or on behalf of such Party to the other Party pursuant
to this Agreement, and (if disclosed in writing or other tangible
medium) is marked or identified as confidential at the time of
disclosure to the receiving Party or (if otherwise disclosed) is
identified as confidential at the time of disclosure to the
receiving Party and described as such in writing within thirty (30)
days after such disclosure. Notwithstanding the foregoing,
Confidential Information of a Party shall not include information
which, and only to the extent the receiving Party can establish by
written documentation, (a) has been generally known prior to
disclosure of such information by the disclosing Party to the
receiving Party; (b) has become generally known, without the fault
of the receiving Party, subsequent to disclosure of such
information by the disclosing Party to the receiving Party; (c) has
been received by the receiving Party at any time from a source
other than the disclosing Party, rightfully having possession of
and the right to disclose such information free of confidentiality
obligations; (d) has been otherwise known by the receiving Party
free of confidentiality obligations prior to disclosure of such
information by the disclosing Party to the receiving Party; or (e)
has been independently developed by employees or others on behalf
of the receiving Party without use of such information disclosed by
the disclosing Party to the receiving Party (each of the
aforementioned (a) to (e) a "Confidentiality
Exception").
"Effective
Date" shall have the meaning set forth in the preamble to
this Agreement.
"FDA"
shall mean the Food and Drug Administration of the United States,
or the successor thereto, or its foreign equivalent in Canada, the
EU or elsewhere.
"Force
Majeure" means an event or circumstance arising outside of
the reasonable control of a party, such as any act of God, flood,
natural disaster, embargo, acts of civil or military authorities,
terrorism, labor strikes, governmental embargos, and governmental
orders.
"IND"
shall mean an investigational new drug application or similar
application which is required to be filed with the FDA prior to
commencing a clinical investigation of a drug pursuant to (US) 21
C.F.R. 312, or its foreign equivalent in Canada, the EU or
elsewhere.
"Intellectual
Property" or "IP" shall mean all inventions (whether or not
patentable), discoveries, trade secrets, Confidential Information,
Know-How, data, technology, formulae, methods, processes,
protocols, techniques, compositions, and other protectible
intangible rights, together with all related Patent Rights,
copyrights, trade secret rights, and other legally enforceable
rights.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
"Know-How" shall mean all trade secrets, know-how, data,
information, compositions and other technology (including, but not
limited to, formulae, procedures, protocols, techniques and results
of experimentation and testing) which are necessary or useful to
make, use, develop, sell or seek regulatory approval to market a
composition, or to practice any method or process, at any time
claimed or disclosed in any issued patent or pending patent
application directly and specifically applicable to the Licensed
Patents, the Licensed IP, or the Licensed Products.
"Licensed
IP" shall have the meaning as defined in Exhibit
B.
"Licensed
Patents" shall mean the Patent Rights applicable to the
Licensed IP.
"Licensed
Products" shall mean any product or service that if
made, used, provided, offered to be provided, sold, offered for
sale or imported would infringe (but for the License Agreement) a
Valid Claim of the Licensed Patents, or that otherwise uses or
incorporates the Licensed IP.
"Milestone
Event" shall have the meaning as defined in Section
4.1.
"Milestone
Payment" shall have the meaning as defined in Section
4.1.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
"NDA" shall mean a New Drug Application, or similar
application for marketing approval of a Product for use in the
Field submitted to the FDA, or its foreign equivalent in Canada,
the EU or elsewhere.
"Net Sales" shall mean, with respect to any
Therapeutic-Related Licensed Product, the gross sales price of such
Therapeutic-Related Licensed Product invoiced by Licensee or its
Affiliates to customers who are not Affiliates (or are Affiliates
but are the end users of such Therapeutic-Related Licensed Product)
less, to the extent actually paid or accrued by License or its
Affiliate (as applicable), (a) reasonable credits, allowances,
discounts and rebates to, and chargebacks from the account of, such
customers for nonconforming, damaged, out-dated and returned
Therapeutic-Related Licensed Product; (b) freight and insurance
costs incurred by License or its Affiliate (as applicable) in
transporting such Therapeutic-Related Licensed Product to such
customers; (c) reasonable cash, quantity and trade discounts,
rebates and other price reductions for such Therapeutic-Related
Licensed Product given to such customers under price reduction
programs; (d) sales, use, value-added and other direct taxes
incurred on the sale of such Therapeutic-Related Licensed Product
to such customers; (e) customs duties, tariffs, surcharges and
other governmental charges incurred in exporting or importing such
Therapeutic-Related Licensed Product to such customers; and (f) a
reasonable allowance for uncollectible or bad debts determined in
accordance with generally accepted accounting
principles.
"Party"
shall mean either VistaGen or UHN; and "Parties" shall mean both
VistaGen and UHN.
"Patent
Rights" shall mean (a) all patents and patent applications
worldwide describing the Licensed IP listed on Exhibit B hereto,
(b) all divisions, continuations, continuations-in-part, that claim
priority to, or common priority with, the patent applications
listed in clause (a) above or the patent applications that resulted
in the patents described in clause (a) above, and (c) all patents
that have issued or in the future issue from any of the foregoing
patent applications, including utility, model and design patents
and certificates of invention, together with any reissues,
renewals, extensions or additions thereto worldwide.
"Person" shall mean an individual, corporation, partnership,
limited liability company, trust, business trust, association,
joint stock company, joint venture, pool, syndicate, sole
proprietorship, unincorporated organization, governmental authority
or any other form of entity not specifically listed
herein.
"Phase I Clinical Trial" shall mean a human clinical
trial that is intended to initially evaluate the safety and/or
pharmacological effect of a Product in subjects or that would
otherwise satisfy requirements of (US) 21 C.F.R. 312.21(a), or its
foreign equivalent in Canada, the EU or elsewhere.
"Phase
II Clinical Trial" shall mean a human clinical trial in any
country that is intended to initially evaluate the effectiveness of
a Product for a particular indication or indications in patients
with the disease or indication under study or would otherwise
satisfy requirements of (US) 21 C.F.R. 312.21(b), or its foreign
equivalent in Canada, the EU or elsewhere.
"Phase
III Clinical Trial" shall mean a human clinical trial in any
country, the results of which could be used to establish safety and
efficacy of a Product as a basis for an NDA or would otherwise
satisfy requirements of (US) 21 C.F.R. 312.21(c), or its foreign
equivalent in Canada, the EU or elsewhere.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
"Revenues" shall mean (i)Net Sales of Therapeutic-Related
Licensed Product(s) sold by Licensee and its Affiliates, (ii)
Sublicensing Consideration received by Licensee and its Affiliates
from Sublicense Agreements, and (iii) Service Sales in respect of
Service-Related Licensed Produces).
"Service-Related
Licensed Product" shall mean a Licensed Product (i)
that is used in and/or for the provision of a research, development
or other service to a third party, or (ii) for use in, or as part
of, a diagnostic kit or service.
"Service
Sales" shall mean, with respect to any Service-Related
Licensed Product, the gross amount of monies received for,
associated with, or in respect of Service-Related Licensed
Product(s) invoiced by Licensee or its Affiliates to customers or
otherwise to third parties who are not Affiliates (or are
Affiliates but are the end users, beneficiaries, or otherwise
recipients of such Service-Related Licensed
Product(s)).
"Sublicense
Agreement" shall mean any agreement or commitment pursuant
to which any of the rights of Licensee under this Agreement are
sublicensed or otherwise extended, granted or given to a Third
Party (a Sublicensee).
"Sublicensee"
shall mean any Third Party to whom Licensee (or its Affiliates)
grants rights to use some of Licensee's rights under this
Agreement.
"Sublicensing Consideration" shall mean the aggregate
consideration received by Licensee or its Affiliates in
consideration for granting sublicense rights to a Sublicensee under
the Licensed IP, including without limitation license fees,
milestone fees, minimum royalties, and earned
royalties, but
excluding (a) amounts received to fund or reimburse
Licensee's or its Affiliates' cost to perform research, development
or similar services specifically and directly associated with
Licensed Products, (b) amounts received in reimbursement of
Licensed IP patent or other Licensed IP-related out-of-pocket
expenses specifically and directly associated with Licensed
Products; and (c) amounts received in consideration for the sale of
any debt or securities of Licensee or its Affiliates.
"Therapeutic-Related Licensed Product" shall mean a Licensed
Product that forms a constituent part of a therapeutic agent for
use in human medical or veterinary purposes.
"Third
Party" shall mean any Person other than Licensor, Licensee
and their respective Affiliates.
"Valid
Claim" shall mean a claim of an issued and unexpired patent
included within the Licensed Patent, which has not been held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
B
LICENSED IP
Licensed
IP shall mean all inventions described in U.S. Provisional Patent
Application Serial No. 61/377,665 and International Patent
Application Serial No. PCT/CA2011/000965 and any application for
Letters Patent claiming priority thereto and/or disclosing
inventions disclosed therein, and in and to any Letters Patent or
Patents in the United States of America and all foreign countries
which may be granted therefor and thereon, and in and to any and
all conversions, divisions, continuations and continuations-in-part
of said application, or reissues or extensions of said Letters
Patent or Patents, and all rights under the International
Convention for the Protection of Industrial Property.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
C THIRD PARTY LICENSE
RIGHTS
[TO BE
COMPLETED, IF APPLICABLE]
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE
B
LICENSE
AGREEMENT NUMBER TWO
(See
attached)
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
LICENSE
AGREEMENT
dated
as of 22 December 2014
between
UNIVERSITY
HEALTH NETWORK,
(as
"Licensor")
and
VISTAGEN
THERAPEUTICS, INC.
(as
"Licensee"}
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
1.
DEFINITIONS
2.
REPRESENTATIONS AND
WARRANTIES
2.1. Mutual
Representations and
Warranties
2.2. Licensor
Representations and
Warranties
3. LICENSE
GRANT
3.1. Licensed
IP
3.2.
Availability of the Licensed
IP
3.3. Reserved
Right
4. FINANCIAL
CONSIDERATIONS
4.1.
Development-Based Milestone
Payments
4.2.
Licensing Fees and
Royalties
5. ROYALTY
REPORTS, PAYMENTS, AND
ACCOUNTING
5.1. Royalty
Reports
5.2. Payment
Terms
5.3.
Audits
6. RESEARCH
AND
DEVELOPMENTOBLIGATIONS
6.1. Research
and Development
Efforts
6.2. R&D
Plan
6.3
Records
6.4
Reports
7.
CONFIDENTIALITY
7.1
Confidential lnformation
7.2 Terms of
this
Agreement
8.
PATENTS
8.1. Patent
Prosecution and
Maintenance
8.2.
Notification of
Infringement
8.3.
Enforcement of Patent
Rights
8.4.
Cooperation
9.
TERMINATION
9.1.
Expiration
9.2.
Termination by Mutual
Consent
9.3.
Termination by
Licensee
9.4.
Termination for
Cause
9.5.
Termination Upon Licensee
Insolvency
9.6. Effect
of Expiration or
Termlnation
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
(continued)
10.
INDEMNIFICATION
10.1.
Indemnification
10.2.
Procedure
10.3.
lnsurance
11.
FORCE
MAJEURE
12.
GENERAL
PROVISIONS
12.1.
Notices
12.2. Further
Representations, Warranties &
Liability
12.3. Dispute
Resolution
12.4.
Assignment
12.5. Waivers
and
Amendments
12.6. Entire
Agreement
12.7.
Severability
12.8.
Waiver
12.9.
Counterparts
EXHIBITS
EXHITIB
A DEFINITIONS
EXIBIT
B LICENSED IP
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
LICENSE
AGREEMENT
THIS
LICENSE AGREEMENT NUMBER 4 (this "Agreement") is dated as of
22 December 2014 (the
"Effective Date"),
and is entered into by and between (i) University Health Network,
an Ontario corporation, incorporated under the Toxxxxx Xxxxxxxx Xxx
0000 ("Licensor"),
having a principal office at 190 Xxxxxxxxx Xxxxxx, X. Xxxxxx
Xxxxxxx Building - Roxx 00-000, Xxxxxxx, Xxxxxxx XXX 0X0, Xxxxxx,
and
(ii) VistaGen
Therapeutics, Inc., a California corporation ("Licensee"), having a place of
business at 340 Xxxxxxxx Xxx, Xxxxx Xxx Xxxxxxxxx, XX
00000.
WHEREAS, Licensor
owns or has rights in the licensed IP (as defined in Exhibit
B).
WHEREAS, Licensee
desires to obtain an exclusive license under Licensor's rights in
the Technology on the terms and conditions set forth
below.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:
1.
DEFINITIONS
For
purposes of this Agreement, the terms defined in Exhibit A shall
have the defined meanings set forth in Exhibit A. Unless otherwise
noted, all dollar amounts are quoted in US dollars.
2.
REPRESENTATIONS AND WARRANTIES
2.1. Mutual Representations and
Warranties. Each Party hereby represents and warrants to the
other Party as follows:
2.1.1. Such Party is a
corporation duly organized, validly existing and in good standing
under the laws of the state, province or country in which it is
incorporated.
2.1.2. Such Party (a) has
the corporate power and authority and the legal right to enter into
this Agreement and to perform its obligations hereunder, and (b)
has taken all necessary corporate action on its part to authorize
the execution and delivery of this Agreement and the performance of
its obligations hereunder. This Agreement has been duly executed
and delivered on behalf of such Party, and constitutes a legal,
valid, binding obligation, enforceable against such Party in
accordance with its terms.
2.1.3. All necessary
consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by such Party
in connection with entering into this this Agreement have been
obtained.
2.1.4. The execution and
delivery of this Agreement and the performance of such Party's
obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws or regulations, and (b) do not
conflict with, or constitute a default under, any contractual
obligation of It.
2.2. Licensor Representations and
Warranties. Licensor hereby represents and warrants to
Licensee that, as of the Effective Date, Licensor, to the best of
Its knowledge, (a) is the
sole owner of the Licensed IP, and (b) other than as noted in
Exhibit C, has not granted to any Third Party any license or other
interest In the Licensed IP, and (c) is not aware of any Third
Party patent, patent application or other intellectual property
rights (other than any inventions identified as prior art in the
patents or patent applications licensed to Licensee hereunder) that
would be infringed (i) by practicing any process or method or by
making, using or selling any composition which is claimed or
disclosed in the Licensed IP, or (ii) by making, using or selling
Licensed Products (but only to the extent that the making, using or
selling of Licensed Products is covered by Licensed IP)1 and {d) is
not aware of any infringement or misappropriation by a Third Party
of the Licensed IP. Notwithstandingthe foregoing, Licensor is under
no duty, obligation or requirement to perform or conduct any legal
inquiry or other search, analyses or assessment pertaining to
patentability, validity, infringement and/or legal status in
respect of any Licensed IP and Licensed Patents.
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
3. LICENSE GRANT
3.1. Licensed IP. Subject to Section
3.3, Licensor hereby grants to Licensee an exclusive license (with
the right to grant sublicenses through multiple tiers) under the
Licensed IP to conduct research and to develop, make, have made,
use, offer for sale, sell and import Licensed Products, worldwide
and.for all fields of use. Licensee shall promptly provide to
Licensor a copy of any Sublicense Agreement. The grant of any such
Sublicense Agreement will not relieve Licensee of its obligations
under this Agreement.
3.2. Availability of the Licensed
IP. Within ten (10) days of the Effective Date, Licensor
shall provide Licensee with a copy of all information and documents
available to Licensor relating to the filing and prosecution of
patent applications encompassing the Licensed IP.
3.3. Reserved Right. Licensor
reserves and retains the non-exclusive, sublicenseable right to use
the Licensed IP for non-commercial research purposes and/or
academic educational purposes, without any financial obligation to
Licensee for so using the Licensed IP.
4. FINANCIAL
CONSIDERATIONS
4.1. Development Based Milestone
Payments. At such time as Licensee (or its Affiliates or
Sublicensees} achieve a Milestone Event as described below for a
specific Licensed Product, Licensee shall pay to Licensor the
Milestone Payment specified below. The specified milestone payment
shall be made within thirty (30) days after the occurrence of the
Milestone Event.
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A.
"Milestone
Event" for Therapeutic-Related Licensed
Product *
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"Milestone Payment"
(US$)
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(1)
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Acceptance
by FDA (first country) of filing of IND
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$150,000
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(2)
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First
patient enrolled for Phase II Clinical Trial
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$250,000
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(3)
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First
patient enrolled for Phase Ill Clinical Trial
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$1,500,000
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(4)
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FDA
(first country) Final Approval of NOA for
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$2,000,000
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Licensed
Product
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B. "Milestone
Event" for Service-Related Milestone Licensed
Product
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"Milestone Payment"
(US$)
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(1)
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First
anniversary of execution of an agreement in respect of (in whole or
in part) a Service-Related Licensed Product.
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$50,000
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
For the
purpose of this Section 4.1 "Final Approval" shall mean approval by
the FDA for marketing a Therapeutic-Related Licensed Product that
is not conditioned on any other event (or if an approval is
conditioned upon an event, then the occurrence of that event),
provided, however, such other events shall specifically not include
FDA requirements to conduct post marketing studies and any
requirement for such post marketing studies shall not be deemed to
delay the Final Approval.
* Once
a Milestone Payment has been made for a specific Licensed Product,
if there are later modifications, improvements, reformulations,
combinations, or other changes using the same molecule which
constitutes said Licensed Product (i.e., a "Related Product"), then
no duplicate Milestone Payment will be owed when that Related
Product achieves the same Milestone Event for which the Milestone Payment was
previously made for said specific Licensed Product. Similarly, if
there is a failure in product development, resulting in the
substitution or replacement of the failed molecule with a new
molecule, to the extent that a Milestone Event had previously been
achieved by the failed molecule and the corresponding Milestone
Payment paid, then no duplicate Milestone Payment will be owed when
the new molecule achieves the same Milestone Event for which the
Milestone Payment was previously made for the failed
molecule.
** But
not more than 10% of the annual revenues received from said
agreement, continuing annually until the cumulative aggregate of
said 10% payments reach $50,000.
4.2. Licensing Fees and
Royalties.
4.2.1. Upfront License Fee. Within six
(6) months of the Effective Date, Licensee shall pay to UHN a
one-time upfront non-refundable license Fee ofTwenty Five Thousand
Dollars ($25,000}.
4.2.2. Patent Reimbursement. Within
six (6} months of the Effective Date, Licensee shall reimburse UHN
a total of (i) $16,140.71 for patent costs related to the Licensed
IP incurred by UHN prior to the Effective Date and (ii) such patent
costs reasonably incurred by UHN, if any, after the Effective Date
and prior to six (6) months from the Effective Date, in each case
as provided under subsection 8.1below..
4.2.3. Royalty Rate. Licensee shall
pay to Licensor three percent (3%) of the first $25 million of
cumulative Revenues received by Licensee or Its Affiliates, and two
percent (2%) of all additional cumulative Revenues received by
licensee or its Affiliates, subject to reductions pursuant to
Sections 4.2.4 and 4.2.S.
4.2.4. Third Party Royalties. If
Licensee or its Affiliates Is required to pay royalties to any
Third Party that are, in the opinion of an Independent patent
attorney (reasonably acceptable to both parties), necessary to
practice the inventions claimed in the Licensed IP, then Licensee
shall have the right to credit such Third Party royalty payments
against the royalties owing to Licensor under Section
4.2.3;provided. however. that the foregoing
credits shall not reduce the amount of the royalties payable to
Licensor under Section 4.2.3 above by more than fifty percent
(50%).
4.2.5. Combination Products. If a
Product consists of (i) components that are covered by Licensor's
Valid Claims, plus (ii) additional active pharmaceutical agents, or
functional components reasonable necessary for formulation or
delivery of the Product that are not covered by a Valid Claim, but
that are covered by a valid claim of a Third Party patent, then for
purposes of the royalty payments under Section 4.2.3, the Revenues
shall be equitably allocated between the components covered by
Licensor's Valid Claim and the components covered by the Third
Party patent, with only the portion of Revenues allocated to
Licensor's Valid Claims being used for purposes of the royalty
calculation in Section 4.2.3 for such combination Product. To the
extent the parties are unable to agree on the equitable allocation
described above, any dispute shall be resolved in accordance with
Section 12.3 of this Agreement. Notwithstandingthe aforementioned,
the foregoing allocation shall not reduce the amount of the
royalties payable to Licensor under Section 4.2.3 above by more
than fifty percent (50%).
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
5.1. Royalty Reports. Within sixty
(60) days after the end of each calendar year during the term of
this Agreement following the receipt by Licensee or its Affiliates
of Revenues, Licensee shall furnish to Licensor a quarterly written
report showing in reasonably specific detail (a) the calculation of
Revenues for such quarter; and (b) the calculation of the royalties
that shall have accrued based upon such Revenues.
5.2. Payment Terms. Royalties shown
to have accrued by each royalty report provided for under Section
5.1above shall be due on the date such royalty report is
due.
5.3. Audits.
5.3.1. Upon the written
request of Licensor and not more than once in each calendar year,
Licensee and its Affiliates shall permit an independent certified
public accounting firm of nationally recognized standing selected
by Licensor and reasonably acceptable to Licensee, at Licensor's
expense, to have access during normal business hours to such of the
financial records of Licensee and its Affiliates as may be
reasonably necessary to verify the accuracy of the payment reports
hereunder for the eight (8) calendar quarters immediately prior to
the date of such request (other than records for which Licensor has
already conducted an audit under this Section).
5.3.2. If such accounting
firm concludes that additional amounts were owed during the audited
period, Licensee shall pay such additional amounts within thirty
(30) days after the date Licensor delivers to Licensee such
accounting firm's written report so concluding. The fees charged by
such accounting firm shall be paid by Licensor; provided, however,
if the audit discloses that the royalties paid by Licensee for such
period were more than seven percent (7%) below the royalties
actually due and payable for such period, then Licensee shall pay
the reasonable fees and expenses charged by such accounting
firm.
5.3.3. Licensor shall
cause Its accounting firm to retain all financial information
subject to review under this Section 5.3 in strict confidence;
provided, however, that Licensee shall have the right to require
that such accounting firm, prior to conducting such audit, enter
into an appropriate non-disclosure agreement with Licensee
regarding such financial information. The accounting firm shall
disclose to licensor only whether the reports are correct or not
and the amount of any discrepancy. No other information shall be
shared. Licensor shall treat all such financial information as
Licensee's Confidential Information
6. RESEARCH
AND DEVELOPMENT OBLIGATIONS
6.1. Research and Development
Efforts. Licensee (together with its Affiliates and
Sublicensees) shall use its commercially reasonable efforts to
conduct such research, development and preclinical and human
clinical trials as Licensee reasonably determines are necessary or
desirable to obtain regulatory approval to manufacture and market
such Licensed Products as Licensee reasonably determines are
commercially feasible; and Licensee (together with its Affiliates
and Sublicensees) shall use its commercially reasonable efforts to
obtain regulatory approval to market, and following approval to
commence marketing and to market each such Licensed Product as
Licensee reasonably determines are commercially
feasible.
6.2. R&D Plan. Within three (3)
months after the Effective Date, Licensee shall furnish to Licensor
a copy of Licensee's Research and Development Plan ("R&D Plan") for Licensed
Products; and a status and progress report as to Licensee's
implementation of the R&D Plan shall be furnished to Licensor
annually thereafter, together with an update for the R&D Plan
for the next year. The parties acknowledge that the R&D Plan
will represent the optimal and desired goals and timeline for
development of the Licensed Products, and that there is no
guarantee of achieving the goals within said timeline.
6.3. Records. Licensee shall
maintain records, in sufficient detail and in good scientific
manner, which shall reflect all work done and results achieved in
the performance of its research and development regarding the
Licensed Products.
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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-56-
Exclusive License and Sublicense Agreement
6.4. Reports. By April 1 of each
calendar year during the term of this Agreement, Licensee shall
prepare and deliver to Licensor a written summary report which
shall describe (a) the research performed to date employing the
Licensed IP, (b) the progress of the development, and testing of
Licensed Products in clinical trials, and (c) the status of
obtaining regulatory approvals to market Licensed
Products.
7.
CONFIDENTIALITY
7.1. Confidential Information. The
reports finished by Licensee to Licensor pursuant to Sections 4, 5
and 6 shall be treated as Licensee's Confidential Information.
During the term of this Agreement, and for a period of five (5)
years following the expiration or earlier termination hereof,
Licensor shall maintain in confidence all Confidential Information
of Licensee that is disclosed to Licensor, and shall not use,
disclose or grant the use of the Confidential Information except on
a need to-know basis to those directors, officers, employees
and agents, to the extent such disclosure isreasonably
necessary in connection with exercising its rights under this
Agreement.
7.2. Terms of this Agreement. Except
as otherwise required by applicable laws, Licensor and Licensee
shall not disclose any terms or conditions of this Agreement to any
Third Party without the prior consent of the other Party.
Notwithstandingthe foregoing, either Party may disclose the
existence of this Agreement and the general nature of the Licensed
IP covered by this Agreement (without disclosing any financial
terms); and Licensee may disclose the term of this Agreement to any
existing or prospective investor or business associate who has a
need to know, subject to a customary confidentiality
agreement.
8.
PATENTS
8.1. Patent Prosecution and
Maintenance. Licensee shall have the right to control, at
its sole cost, the preparation, filing, prosecution, defense in
post-grant and/or post issuance administrative procedures, and
maintenance of all patents and patent applications in respect of
Licensed Patents in the Territory and shall be solely responsible
for all prior and future costs incurred in the preparation, filing,
prosecution and maintenance of such patents and patent applications
from the Effective Date through the termination of this Agreement.
For further clarification, Licensee shall reimburse Licensor {i)
$16,140.71 for costs incurred by UHN for the preparation, filing,
prosecution of Licensed IP prior to the Effective Date, pursuant to
Section 4.2.2 hereof, and (ii) all reasonable costs related to the
future preparation, filing, prosecution, defense in post-grant
and/or post issuance administrative procedures, and maintenance of
all patents and patent applications in respect of Licensed Patents,
If any, incurred by UHN at Licensee's request after the Effective
Date. All such applications in respect of Licensed Patents shall be
filed in the name of Licensor. Licensee shall give Licensor an
opportunity to review and comment on the text of each patent
application subject to this Section 8.1before filing, and shall
supply Licensor with a copy of such patent application as filed,
together with notice of its filing date and serial number. Licensor
shall cooperate with Licensee, execute all lawful papers and
instruments and make all rightful oaths and declarations as may be
necessary in the preparation, prosecution and maintenance.of all
patents and other filings referred to in this Section 8.1. If
Licensee, in its sole discretion, decides to abandon the
preparation, filing, prosecution or maintenance of any patent or
patent application In respect of Licensed Patents, then Licensee
shall notify Licensor in writing thereof and following the date of
such notice (a) Licensor shall be responsible for and shall
control, at its sole cost, the preparation, filing, prosecution and
maintenance of such patents and patent applications, and {b}
licensee shall thereafter have no license under this Agreement to
such patent or patent application.
8.2. Notification of Infringement.
Each Party shall notify the other Party of any substantial
infringement known to such Party of any Licensed Patents and shall
provide the other Party with the available evidence, if any, of
such infringement.
-57-
8.3. Enforcement of Patent Rights.
Licensee, at its sole expense, shall have the right to determine
the appropriate course of action to enforce Licensed Patents or
otherwise xxxxx the infringement thereof, to take (or refrain from
taking) appropriate action to enforce Licensed Patents, to defend
any declaratory judgments seeking to invalidate or hold the
licensed Patents unenforceable, to control any litigation or other
enforcement action and to enter into, or permit, the settlement of
any such litigation, declaratory judgments or other enforcement
action with respect to Licensed Patents, in each case in Licensee's
own name and, if necessary for standing purposes, in the name of
Licensor and shall consider, in good faith, the interests of
Licensor in so doing. If Licensee does not, within six (6) months
after receipt of notice from Licensor take reasonable steps to
xxxxx the infringement or file suit to enforce the Licensed Patents
against at least one infringing Party, Licensor shall have the
right to take whatever action it deems appropriate to enforce the
Licensed Patents; provided, however, that, within thirty (30) days
after receipt of notice of Licensor's Intent to file such suit,
Licensee shall have the right to jointly prosecute such suit and to
fund up to one-half(*) the costs of such suit. The Party
controlling any such joint enforcement action shall not settle the
action or otherwise consent to an adverse Judgment in such joint
action that diminishes the rights or interests of the
non-controlling Party without the prior written consent of the
other Party. All monies recovered upon the final Judgment or
settlement of any
such suit to enforce the Licensed Patents shall be shared In
relation to the damages (including attorneys' fees and expenses for
the enforcement action) incurred by each Party as a result of such
infringement; and such recovery shall not be treated as Revenues
for purposes of Section 4.2.1. Notwithstanding the foregoing, to
the extent any part of the recovery includes a reasonable royalty
payable to Licensee, such royalty amounts shall be deemed Revenue
on which Licensee will pay a royalty to Licensor in accordance with
Section 4.2.1.
8.4. Cooperation. In any suit to
enforce and/or defend the Licensed Patents pursuant to this Section
8, the Party not in control of such suit shall, at the request and
expense of the controlling Party, reasonably cooperate and, to the
extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples,
specimens, and the like.
9.
TERMINATION
9.1. Expiration. Subject to Sections
9.3 and 9.4 below, this Agreement shall expire on the expiration of
Licensee's obligation to make payments to Licensor under Section 4
above. The license grant under Section 3.1shall be effective at all
times prior to such expiration.
9.2. Termination by Mutual Consent.
The Parties may terminate this Agreement at any time by mutual
consent, which consent shall be evidenced by a written agreement or
other such documentation duly executed by both
Parties.
9.3. Termination by Licensee.
Licensee may terminate this Agreement, in its sole discretion, upon
thirty (30) days prior written notice to Licensor, provided,
however, Licensee shall remain liable for any payments accrued
under this Agreement prior to the date of termination.
9.4. Termination for Cause. Except
as otherwise provided in Section 11, Licensor may terminate this
Agreement upon or after the breach of any material provision of
this Agreement by Licensee, if Licensee has not cured such breach
within ninety (90) days after receipt of express written notice
thereof by Licensor; provided, however, if any default is not
capable of being cured within such ninety (90) day period and
Licensee is diHgently undertaking to cure such default as soon as
commercially feasible thereafter under the circumstances, Licensor
shall have no right to terminate this Agreement.
9.5. Termination Upon Licensee
Insolvency. This Agreement shall terminate at least one day
prior to the occurrence of any of the following events: (i) the
Licensee files a voluntary petition in bankruptcy or insolvency or
shall petition for reorganization under the bankruptcy law, or
makes a general assignment for the benefit of creditors, or
otherwise acknowledges insolvency or is adjudged bankrupt; (ii) the
Licensee consents to an involuntary petition in bankruptcy or if a
receiving order is given against it under any applicable
bankruptcy/insolvency law in a jurisdiction; (iii) the appointment
of a receiver or other similar representative for the Licensee by a
court of competent jurisdiction; or (iv) Licensee fails to carry on
business in the normal course.
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*****
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
9.6. Effect of Expiration or
Termination. Expiration or termination of this Agreement
shall not relieve the Parties of any obligation accruing prior to
such expiration or termination, and the provisions of Sections 1,
2, 5, 7, 9.1, 9.6, 10 and 12 shall survive the expiration or
termination of this Agreement. Upon any termination of this
Agreement, Licensor shall grant a direct license to any sublicense
of Licensee hereunder having the same scope as such subllcense and
on terms and conditions no less favorable to such Sublicensee than
the terms and conditions of this Agreement, provided that such
Sublicensee is not in default of any applicable obligations under
this Agreement and agrees in writing to be bound by the terms and
conditions of such direct license. Upon any termination of this
Agreement, for a period of six (6) months thereafter, Licensee (and
its Affiliates and Sublicensees) shall continue to be entitled to
finish production of any Products which were in process at the time
of termination, and Licensee (and its Affiliates and Sublicensees)
shall be entitled to sell all Products which were in inventory or
in process at the time of termination, so long as licensee (and its
Affiliates and Sublicensees) continues to make the reports and pay
the scheduled royalties for said sales as set forth In this
Agreement.
10.
INDEMNIFICATION
10.1. Indemnification. Licensee shall
defend, indemnify and hold Licensor (which for purposes of clarity,
is recognized to include, without limitation, its directors,
officers, employees, research trainees, students and agents)
harmless from all losses, liabilities, damages and expenses
(including attorneys' fees and costs) incurred as a result of any
claim, demand, action or proceeding arising out of any breach of
this Agreement by Licensee, any damages or personal injury
resulting from the use, application of, distribution, sale or other
exploitation of the Licensed IP, Licensed Patents and the Licensed
Product by Licensee, its Affiliates or Sublicensees, or the gross
negligence or willful misconduct of Licensee In the performance of
its obligations under this Agreement, except in each case to the
extent arising from the gross negligence or willful misconduct of
Licensor or the breach of this Agreement by Licensor.
10.2. Procedure. Licensor promptly
shall notify Licensee of any liability or action in respect of
which Licensor intends to claim such indemnification, and Licensee
shall have the right to assume the defense thereof with counsel
selected by licensee. The indemnity agreement in this Section 10
shall not apply to amounts paid in settlement of any loss, claim,
damage, liability or action if such settlement is effected without
the consent of Licensee, which consent shall not be withheld
unreasonably. The failure to deliver notice to Licensee within a
reasonable time after the commencement of any such action, if
prejudicial to its ability to defend such action, shall relieve
Licensee of any liability to Licensor under this Section 10, but
the omission so to deliver notice to Licensee will not relieve it
of any liability that it may have to Licensor otherwise than under
this
Section
10. Licensor under this Section 10, its employees and agents, shall
cooperate fully with Licensee and its legal representatives in the
investigation and defense of any action, claim or liability covered
by this indemnification.
10.3. Insurance. During the term of
this Agreement, Licensee shall maintain at its own
expense:
10.3.1. Comprehensive
general liability insurance for claims for damages arising from
bodily injury (including death) and property damages caused by, or
arising out of, acts or omissions of its employees, in such amounts
as are customary and reasonable in the Licensee's
industry.
10.3.2. Product liability
insurance in such amounts as are customary and reasonable in the
Licensee's industry.
10.3.3. Maintenance of
such insurance coverage shall not relieve Licensee of any
responsibility under this Agreement for damage In excess of the
insurance limits.
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*****
|
VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
11. FORCE MAJEURE
Neither
Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from Force Majeure events.
12. GENERAL PROVISIONS
12.1. Notices. Any consent, notice or
report required or permitted to be given or made under this
Agreement by one Party to the other Party shall be in writing,
delivered by any available means to such other Party at its address
indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor and shall be
effective upon receipt by the addressee.
If to
Licensor:
Director
University Health
Network
Office
ofTechnology Development & Commercialization MaRS Centre,
Heritage Building
101College Street,
Suite 150 Toronto, Ontario
Canada
MSG 1L7
If to
Licensee:
Chief
Executive Officer
VistaGen
Therapeutics, Inc.
000
Xxxxxxxx Xxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
With
Copy to:
Xxxx
Xxxxx, Esq.
Law
Offices of Xxxx Xxxxx 0000 Xxxxxxx Xxxx
Xxxxx
000
Xxxxxxxx, XX
00000
12.2. Further Representations, Warranties
& Liability.
(a)
Licensee represents and warrants to Licensor that Licensee has the
power to enter into this Agreement and to perform Its obligations,
and that Licensee has taken necessary action for the execution of
this Agreement to constitute a binding obligation enforceable
against Licensee.
{b)
Licensor represents and warrants to Licensee that Licensor has the
power to enter into this Agreement and to perform its obligations,
and that Licensor has taken necessary action for the execution of
this Agreement to constitute a binding obligation enforceable
against Licensor.
(c)
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, LICENSOR MAKES NO
CONDITIONS, WARRANTEES, UNDERTAKINGS OF ANY KIND, INCLUDING WITHOUT
LIMITATION, THE ORIGINALITY OR ACCURACY OR PATENTABILITY OR
VALIDITY OR NONINFRINGEMENT OF THE LICENSED PATENT(S), LICENSED IP,
OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT
MATTER OF, THIS AGREEMENT OR THE OWNERSHIP, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE OF THE LICENSED PATENT(S),
LICENSED IP, OR LICENSED PRODUCT($) ARISING UNDER, OR OTHERWISE THE
SUBJECT MATTER OF THIS AGREEMENT.
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
{d)
LICENSOR SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT,
CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY LICENSEE (AND ITS
AFFILIATE(S) AND SUBLICENSEES) OR ANY OTHERS RESULTING FROM THE USE
OF THE OF THE LICENSED PATENT(S), LICENSED IP, OR LICENSED
PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS
AGREEMENT. THE ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, USE,
EXPLOITATION, MANUFACTURE, SALE OR OTHER DISPOSITION AND
PERFORMANCE IN RESPECT OF THE LICENSED PATENT(S), LICENSED IP, OR
LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT MATTER
OF THIS AGREEMENT IS ASSUMED BY LICENSEE.
12.3. Dispute
Resolution.
(a) The Parties agree to
use reasonable best efforts to amicably resolve among themselves
any dispute arising out of this Agreement.
(b) If the Parties are
unable to resolve the dispute under Section 8.S(a), the dispute
shall be referred to the Vice President, Research of Licensor or
the Vice President's designate and the designate of Licensee for
their discussion and resolution. The Parties may agree to mediation
of the dispute (procedural details and process to be determined by
the Parties).
(c) Any dispute which
cannot be amicably settled by the Parties as provided in Sections
8.S(a) and (b} shall be submitted to arbitration in accordance with
the provisions of the (Ontario) Arbitration Act, 1991, S.O. 1991,
c.17, as amended from time to time. The arbitration will take place
in the city of Toronto (Ontario, Canada).
(d) Notwithstanding the
foregoing, either Party shall have the right, without waiving any
right or remedy available to such Party under this Agreement or
otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending
the selection of the mediator(s) or arbitrator(s) hereunder, or
pending the mediator(s)' or arbitrator{s)' determination of any
dispute, controversy or claim hereunder.
12.4. Assignment. Licensee shall not
assign its rights or obligations under this Agreement without the
prior written consent of Licensor; provided. however. that Licensee may,
without such consent, assign this Agreement and Its rights and
obligations hereunder (a) to any Affiliate, or {b) in connection
with the transfer or sale of all or substantially all of its
business to which this Agreement relates, or in the event,of its
merger, consolidation, change in control or similar transaction.
Notwithstanding the aforementioned, Licensee shall remain
responsible for the performance of all obligations under this
Agreement (including, without limitation. the payment of royalties
to Licensor).
12.5. Waivers and Amendments. No
change, modification, extension, termination or waiver of this
Agreement, or any of the provisions herein contained, shall be
valid unless made in writing and signed by duly authorized
representatives of the parties hereto.
12.6. Entire Agreement. This
Agreement embodies the entire agreement between the parties and
supersedes any prior representations, understandings and agreements
between the parties regarding the subject matter hereof. There are
no representations, understandings or agreements, oral or written,
between the parties regarding the subject matter hereof that are
not fully expressed herein.
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VISTAGEN
THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS OF THIS
DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED CONFIDENTIAL
TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY FILED THE
OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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Exclusive License and Sublicense Agreement
12.7. Severability. Any of the
provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the
extent of such invalidity or unenforceability in such jurisdiction,
without rendering invalid or unenforceable the remaining provisions
hereof and without affecting the validity or enforceability of any
of the terms of this Agreement in any other
jurisdiction.
12.8. Waiver. The waiver by either
Party hereto of any right hereunder or the failure to perform or of
a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
12.9. Counterparts. This Agreement
may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one
and the same instrument. Evidence of the execution and delivery of
this Agreement may be by a telecopy transmission to a Party of the
other Party's signed copy of this Agreement.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
IN WITNESS WHEREOF, the
parties have executed this Agreement effective as of the
Effective Date.
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LICENSOR: University of Health Network
By:
Name:/s/
Xxxxxxxxxxx X. Xxxxx
Xxxxxxxxxxx
X. Xxxxx, PhD
Title:
Vice President, Research
LICENSEE: VistaGen Therapeutics, Inc.
Name:/s/ Xxxxx X.
Xxxxx
Xxxxx X. Xxxxx, XX
Title: Chief Executive Officer
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
A
DEFINITIONS
"Affiliate"
shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
"Confidential
Information" shall mean, with respect to a Party, all information
(and all tangible and intangible embodiments thereof), that is
owned or controlled by such Party, is disclosed by or on behalf of
such Party to the other Party pursuant to this Agreement, and (if
disclosed in writing or other tangible medium) is marked or
identified as confidential at the time of disclosure to the
receiving Party or (if otherwise disclosed) is identified as
confidential at the time of disclosure to the receiving Party and
described as such in writing within thirty (30) days after such
disclosure. Notwithstanding the foregoing, Confidential Information
of a Party shall not include information which, and only to the
extent the receiving Party can establish by written documentation,
(a) has been generally known prior to disclosure of such
information by the disclosing Party to the receiving Party; (b) has
become generally known, without the fault of the receiving Party,
subsequent to disclosure of such information by the disclosing
Party to the receiving Party; (c) has been received by the
receiving Party at any time from a source other than the disclosing
Party, rightfully having possession of and the right to disclose
such information free of confidentiality obligations; (d) has been
otherwise known by the receiving Party free of confidentiallty
obligations prior to disclosure of such information by the
disclosing Party to the receiving Party; or
(e) has been independently developed by employees or others on behalf of the receiving Party without use of such information disclosed by the disclosing Party to the receiving Party (each of the aforementioned (a) to (e) a "Confidentiality Exception").
(e) has been independently developed by employees or others on behalf of the receiving Party without use of such information disclosed by the disclosing Party to the receiving Party (each of the aforementioned (a) to (e) a "Confidentiality Exception").
"Effective
Date" shall have the meaning set forth in the preamble to this
Agreement.
"FDA"
shall mean the Food and Drug Administration of the United States,
or the successor thereto, or its foreign equivalent in Canada, the
EU or elsewhere.
"Force
Maieure" means an event or circumstance arising outside of the
reasonable control of a party, such as any act of God, flood,
natural disaster, embargo, acts of civil or military authorities,
terrorism, labor strikes, governmental embargos, and governmental
orders.
"IND"
shall mean an investigational new drug application or similar
application which is required to be filed with the FDA prior to
commencing a clinical investigation of a drug pursuant to (US) 21
C.F.R. 312, or its foreign equivalent in Canada, the EU or
elsewhere.
"Intellectual
Property'' or "IP''
shall mean all inventions (whether or not patentable), discoveries,
trade secrets, Confidential Information, Know-How, data,
technology, formulae, methods, processes, protocols, techniques,
compositions, and other protectable intangible rights, together
with all related Patent Rights, copyrights, trade secret rights,
and other legally enforceable rights.
"Know-How'
shall mean all trade secrets, know-how, data, Information,
compositions and other technology (including, but not limited to,
formulae, procedures, protocols, techniques and results of
experimentation and testing) which are necessary or useful to make,
use, develop, sell or seek regulatory approval to market a
composition, or to practice any method or process, at any time
claimed or disclosed in any
issued patent or pending patent application directly and
specifically applicable to the Licensed Patents, the Licensed IP,
or the Licensed Products.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
"Licensed
IP" shall have the meaning as defined in Exhibit
B.
"Licensed
Patents" shall mean the Patent Rights applicable to the
Licensed IP.
uucensed
Product(s)" shall mean any product or service that if made,
used, provided, offered to be provided, sold, offered for sale or
imported would infringe (but for the License Agreement) a Valid
Claim of the Licensed Patents, or that otherwise uses or
incorporates the Licensed IP.
"Milestone
Event" shall have the meaning as defined in Section 4.1.
"Milestone Payment"
shall have the meaning as defined in Section 4.1.
"NDA"
shall mean a New Drug Application, or similar application for
marketing approval of a Product for use in the Field submitted to
the FDA, or its foreign equivalent in Cqnada, the EU or
elsewhere.
"Net
Sales" shall mean, with respect to any Therapeutic-Related
Licensed Product, the gross sales price of such Therapeutic-Related
Licensed Product invoiced by Licensee or its Affiliates to
customers who are not Affiliates (or are Affiliates but are the end
users of such Therapeutic-Related Licensed Product) less, to the
extent actually paid or accrued by License or its Affiliate (as
applicable), (a) reasonable credits, allowances, discounts and
rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Therapeutic-Related
Licensed Product; (b) freight and insurance costs incurred by
License or its Affiliate (as applicable) in transporting such
Therapeutic Related Licensed Product to such customers; (c)
reasonable cash, quantity and trade discounts, rebates and other
price reductions for such Therapeutic-Related Licensed Product
given to such customers under price reduction programs; (d) sales,
use, value-added and other direct taxes incurred on the sale of
such Therapeutic-Related Licensed Product to such customers; (e)
customs duties, tariffs, surcharges and other governmental charges
incurred in exporting or importing such Therapeutic-Related
Licensed Product to such customers; and (f) a reasonable allowance
for uncollectible or bad debts determined in accordance with
generally accepted accounting principles.
"Party"
shall mean either VistaGen or UHN; and "Parties" shall mean both
VistaGen and UHN.
"Patent
Rights" shall mean (a) all patents and patent applications
worldwide describing the Licensed IP listed on Exhibit B hereto,
(b} all divisions, continuations, continuations-in-part, that claim
priority to, or common priority with, the patent applications
listed in clause (a) above or the patent applications that resulted
in the patents described in clause (a} above, and (c) all patents
that have issued or in the future issue from any of the foregoing
patent applications, including utility, model and design patents
and certificates of invention, together with any reissues,
renewals, extensions or additions thereto worldwide.
"Person"
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
"Phase
I Clinical Trial" shall mean a human clinical trial that is
intended to initially evaluate the safety and/or pharmacological
effect of a Product In subjects or that would otherwise satisfy
requirements of (US) 21C.F.R. 312.21(a), or its foreign equivalent
in Canada, the EU or elsewhere.
"Phase
II Clinical Trial" shall mean a human clinical trial In any country
that is intended to initially evaluate the effectiveness of a
Product for a particular indication or indications in patients with
the disease or indication under study or would otherwise satisfy
requirements of {US) 21 C.F.R. 312.21(b), or its foreign equivalent
in Canada, the EU or elsewhere.
"Phase
Ill Clinical Trial" shall mean a human clinical trial in any
country, the results of which could be used to establish safety and
efficacy of a Product as a basis for .an NOA or would otherwise
satisfy requirements of (US) 21 C.F.R. 312.21(c), or its foreign
equivalent in Canada, the EU or elsewhere.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
"Revenues"
shall mean (i) Net Sales on a country-by-country basis of
Therapeutic-Related Licensed Product(s) sold by Licensee and its
Affiliates on a country-by-country basis, (ii) Sublicensing
Consideration received by Licensee and its Affiliates from
Sublicense Agreements, and (iii) Service Sales on a
country-by-country basis in respect of Service-Related Licensed
Product(s).
"Service-Related
Licensed Product" shall mean a Licensed Product (i) that is
used in and/or for the provision of a research, development or
other se,rvice to a third party, or (ii) for use in, or as part of,
a diagnostic kit or service.
"Service
Sales" shall mean, with respect to any Service-Related
Licensed Product, the gross amount of monies received for,
associated with, or in respect of Service-Related Licensed
Product(s) invoiced by Licensee or its Affiliates to customers or
otherwise to third parties who are not Affiliates (or are
Affiliates but are the end users, beneficiaries, or otherwise
recipients of such Service-Related Licensed Product(s)) less, to
the extent actually paid or accrued by License or its Affiliate (as
applicable), (a) reasonable credits, allowances, discounts and
rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Service-Related
Licensed Product;
(b)
freight and insurance costs incurred by License or its Affiliate
(as applicable) in transporting such Service-Related Licensed
Product to such customers; (c) reasonable cash, quantity and trade
discounts, rebates and other price reductions for such
Service-Related Licensed Product given to such customers under
price reduction programs; (d) sales, use, value-added and other
direct taxes incurred on the sale of such Service-Related Licensed
Product to such customers; (e) customs duties, tariffs, surcharges
and other governmental charges incurred in exporting or importing
such Service-Related Licensed Product to such customers; and (f) a
reasonable allowance for uncollectible or bad debts determined in
accordance with generally accepted accounting
principles.
"Sublicense
Agreement" shall mean any agreement or commitment pursuant to which
any of the rights of Licensee under this Agreement are sublicensed
or otherwise extended, granted or given to a Third Party (a
Sublicensee).
"Sublicensee"
shall mean any Third Party to whom Licensee (or its Affiliates)
grants rights to use some of Licensee's rights under this
Agreement.
"Sublicensing
Consideration" shall mean the aggregate consideration received by
Licensee or its Affiliates in consideration for granting sublicense
rights to a Sublicensee under the Licensed IP, including without
limitation license fees, milestone fees, minimum royalties, and
earned royalties, but
excluding (a) amounts
received to fund or reimburse Licensee's or its Affiliates' cost to
perform research, development or similar services specifically and
directly associated with Licensed Products, (b) amounts received in
reimbursement of Licensed IP patent or other Licensed IP-related
out-of-pocket expenses specifically and directly associated with
Licensed Products; and (c) amounts received in consideration for
the sale of any debt or securities of Licensee or its
Affiliates. "Therapeutic-Related
Licensed Product" shall mean a Licensed Product that forms a
constituent part of a therapeutic agent
for use in human medical or veterinary purposes.
"Third
Party" shall mean any Person other than Licensor, Licensee and
their respective Affiliates.
"Valid
Claim" shall mean a claim of an issued and unexpired patent
included within the Licensed Patent, which has not been held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBITS
LICENSED IP
[*****].
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE
C
LICENSE
AGREEMENT NUMBER THREE
(See
attached)
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE C
LICENSE
AGREEMENT
dated
as of December 9, 2016
between
UNIVERSITY
HEALTH NETWORK,
(as
“Licensor”)
and
VISTAGEN
THERAPEUTICS, INC.
(as
“Licensee”)
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
1.
DEFINITIONS
2.
REPRESENTATIONS
AND WARRANTIES
2.1
Mutual
Representations and Warranties
2.2
Licensor
Representations and Warranties
3.
LICENSE
GRANT
3.1
Licensed
IP
3.2
Availability of the
Licensed IP
3.3
Reserved
Right
4.
FINANCIAL
CONSIDERATIONS
4.1
Development-Based
Milestone Payments
4.2
Licensing Fees and
Royalties
5.
ROYALTY
REPORTS, PAYMENTS, AND ACCOUNTING
5.1
Royalty
Reports
5.2
Payment
Terms
5.3
Audits
6.
RESEARCH
AND DEVELOPMENT OBLIGATIONS
6.1
Research and
Development Efforts
6.2
R&D
Plan
6.3
Records
6.4
Reports
7.
CONFIDENTIALITY
7.1
Confidential
Information
7.2
Terms of this
Agreement
8.
PATENTS
8.1
Patent Prosecution
and Maintenance
8.2
Notification of
Infringement
8.3
Enforcement of
Patent Rights
8.4
Cooperation
9.
TERMINATION
9.1
Expiration
9.2
Termination by
Mutual Consent
9.3
Termination by
Licensee
9.4
Termination for
Cause
9.5
Termination Upon
Licensee Insolvency
9.6
Effect of
Expiration or Termination
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
(continued)
10.
INDEMNIFICATION
10.1
Indemnification
10.2
Procedure
10.3
Insurance
11.
FORCE
MAJEURE
12.
General
Provisions
12.1
Notices
12.2
Further
Representations, Warranties & Liability
12.3
Dispute
Resolution.
12.4
Assignment
12.5
Waivers and
Amendments
12.6
Entire
Agreement
12.7
Severability
12.8
Waiver
12.9
Counterparts
EXHIBITS
EXHITIB
A DEFINITIONS
EXIBIT
B LICENSED IP
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
LICENSE AGREEMENT
THIS
LICENSE AGREEMENT NUMBER 5 (this “Agreement”) is dated
as of December 9, 2016 (the
“Effective
Date”), and is entered into by and between
(i) University Health Network, an Ontario corporation,
incorporated under the University
Health Network Xxx 0000 (“Licensor”), having a
business office at MaRS Centre (Heritage Building), 000 Xxxxxxx
Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxx X0X 0X0, Xxxxxx, and
(ii) VistaGen Therapeutics, Inc., a California corporation
(“Licensee”), having a
place of business at 000 Xxxxxxxx Xxx, Xxxxx Xxx Xxxxxxxxx, XX
00000.
WHEREAS,
Licensor owns or has rights in the Licensed IP (as defined in
Exhibit B).
WHEREAS,
Licensee desires to obtain an exclusive license under
Licensor’s rights in the Technology on the terms and
conditions set forth below.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:
1. DEFINITIONS
For
purposes of this Agreement, the terms defined in Exhibit A
shall have the defined meanings set forth in Exhibit A. Unless
otherwise noted, all dollar amounts are quoted in US
dollars.
2. REPRESENTATIONS
AND WARRANTIES
2.1 Mutual
Representations and Warranties. Each Party hereby represents
and warrants to the other Party as follows:
2.1.1 Such
Party is a corporation duly organized, validly existing and in good
standing under the laws of the state, province or country in which
it is incorporated.
2.1.2 Such
Party (a) has the corporate power and authority and the legal
right to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms.
2.1.3 All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such Party in connection with entering into this this Agreement
have been obtained.
2.1.4 The
execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder (a) do not conflict with
or violate any requirement of applicable laws or regulations, and
(b) do not conflict with, or constitute a default under, any
contractual obligation of it.
2.2 Licensor
Representations and Warranties. Licensor hereby represents
and warrants to Licensee that, as of the Effective Date, Licensor,
to the best of its knowledge, (a) is the sole owner of the Licensed
IP, and (b) other than as noted in Exhibit C, has not granted to
any Third Party any license or other interest in the Licensed IP,
and (c) is not aware of any Third Party patent, patent
application or other intellectual property rights (other than any
inventions identified as prior art in the patents or patent
applications licensed to Licensee hereunder) that would be
infringed (i) by practicing any process or method or by
making, using or selling any composition which is claimed or
disclosed in the Licensed IP, or (ii) by making, using or
selling Licensed Products (but only to the extent that the making,
using or selling of Licensed Products is covered by Licensed IP),
and (d) is not aware of any infringement or misappropriation
by a Third Party of the Licensed IP. Notwithstanding the foregoing,
Licensor is under no duty , obligation or requirement to perform or
conduct any legal inquiry or other search, analyses or assessment
pertaining to patentability, validity, infringement and/or legal
status in respect of any Licensed IP and Licensed
Patents.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
3. LICENSE
GRANT
3.1 Licensed
IP. Subject to Section 3.3, Licensor hereby grants to
Licensee an exclusive license (with the right to grant sublicenses
through multiple tiers) under the Licensed IP to conduct research
and to develop, make, have made, use, offer for sale, sell and
import Licensed Products, worldwide and for all fields of use.
Licensee shall promptly provide to Licensor a copy of any
Sublicense Agreement. The grant of any such Sublicense Agreement
will not relieve Licensee of its obligations under this
Agreement.
3.2 Availability
of the Licensed IP. Within ten (10) days of the Effective
Date, Licensor shall provide Licensee with a copy of all
information and documents available to Licensor relating to the
filing and prosecution of patent applications encompassing the
Licensed IP.
3.3 Reserved
Right. Licensor reserves and retains the non-exclusive,
sublicenseable right to use the Licensed IP for non-commercial
research purposes and/or academic educational purposes, without any
financial obligation to Licensee for so using the Licensed
IP.
4. FINANCIAL
CONSIDERATIONS
4.1 Development-Based
Milestone Payments. At such
time as Licensee (or its Affiliates or Sublicensees) achieve a
Milestone Event as described below for a specific Licensed Product,
Licensee shall pay to Licensor the Milestone Payment specified
below. The specified milestone payment shall be made within thirty
(30) days after the occurrence of the Milestone
Event.
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A.
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“Milestone
Event” for Therapeutic-Related Licensed Product
*
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“Milestone
Payment” (US$)
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(1)
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Acceptance
by FDA (first country) of filing of IND
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$150,000
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(2)
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First
patient enrolled for Phase II Clinical Trial
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$250,000
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(3)
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First
patient enrolled for Phase III Clinical Trial
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$1,500,000
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(4)
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FDA
(first country) Final Approval of NDA for Licensed
Product
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$2,000,000
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B.
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“Milestone
Event” for Service-Related Licensed Product
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“Milestone
Payment” (US$)
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(1)
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First
anniversary of execution of an agreement in respect of (in whole or
in part) a Service-Related Licensed Product.
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$50,000
**
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For the
purpose of this Section 4.1 “Final Approval” shall
mean approval by the FDA for marketing a Therapeutic-Related
Licensed Product that is not conditioned on any other event (or if
an approval is conditioned upon an event, then the occurrence of
that event), provided, however, such other events shall
specifically not include FDA requirements to conduct post marketing
studies and any requirement for such post marketing studies shall
not be deemed to delay the Final Approval.
* Once
a Milestone Payment has been made for a specific Licensed Product,
if there are later modifications, improvements, reformulations,
combinations, or other changes using the same molecule which
constitutes said Licensed Product (i.e., a “Related Product”), then
no duplicate Milestone Payment will be owed when that Related
Product achieves the same Milestone Event for which the Milestone
Payment was previously made for said specific Licensed Product.
Similarly, if there is a failure in product development, resulting
in the substitution or replacement of the failed molecule with a
new molecule, to the extent that a Milestone Event had previously
been achieved by the failed molecule and the corresponding
Milestone Payment paid, then no duplicate Milestone Payment will be
owed when the new molecule achieves the same Milestone Event for
which the Milestone Payment was previously made for the failed
molecule.
** But
not more than 10% of the annual revenues received from said
agreement, continuing annually until the cumulative aggregate of
said 10% payments reach US$50,000.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
4.2 Licensing
Fees and Royalties.
4.2.1 Upfront
License Fee. On the Effective Date, Licensee shall pay to
UHN a one-time upfront non-refundable License Fee of Twenty Five
Thousand Dollars (US$25,000).
4.2.2 Patent
Reimbursement. On the Effective Date, Licensee shall
reimburse UHN a total of (i) for patent costs related to the
Licensed IP incurred by UHN prior to the Effective Date
(CAD$18,979.55 as of WS record on 6 Dec 2016), and (ii) such patent
costs reasonably incurred by UHN, if any, after the Effective Date
and prior to six (6) months from the Effective Date, in each case
as provided under subsection 8.1 below.
4.2.3 Royalty
Rate. Licensee shall pay to Licensor three percent (3%) of
the first US$25 million of cumulative Revenues received by
Licensee or its Affiliates, and two percent (2%) of all additional
cumulative Revenues received by Licensee or its Affiliates, subject
to reductions pursuant to Sections 4.2.4 and
4.2.5.
4.2.4 Third
Party Royalties. If Licensee or its Affiliates is required
to pay royalties to any Third Party that are, in the opinion of an
independent patent attorney (reasonably acceptable to both
parties), necessary to practice the inventions claimed in the
Licensed IP, then Licensee shall have the right to credit such
Third Party royalty payments against the royalties owing to
Licensor under Section 4.2.3; provided, however, that the foregoing
credits shall not reduce the amount of the royalties payable to
Licensor under Section 4.2.3 above by more than fifty percent
(50%).
4.2.5 Combination
Products. If a Product consists of (i) components that are
covered by Licensor’s Valid Claims, plus (ii) additional
active pharmaceutical agents, or functional components reasonable
necessary for formulation or delivery of the Product that are not
covered by a Valid Claim, but that are covered by a valid claim of
a Third Party patent, then for purposes of the royalty payments
under Section 4.2.3, the Revenues shall be equitably allocated
between the components covered by Licensor’s Valid Claim and
the components covered by the Third Party patent, with only the
portion of Revenues allocated to Licensor’s Valid Claims
being used for purposes of the royalty calculation in
Section 4.2.3 for such combination Product. To the extent the
parties are unable to agree on the equitable allocation described
above, any dispute shall be resolved in accordance with Section
12.3 of this Agreement. Notwithstanding the aforementioned, the
foregoing allocation shall not reduce the amount of the royalties
payable to Licensor under Section 4.2.3 above by more than
fifty percent (50%).
5. ROYALTY
REPORTS, PAYMENTS, AND ACCOUNTING
5.1 Royalty
Reports. Within sixty (60) days after the end of each
calendar year during the term of this Agreement following the
receipt by Licensee or its Affiliates of Revenues, Licensee shall
furnish to Licensor a quarterly written report showing in
reasonably specific detail (a) the calculation of Revenues for
such quarter; and (b) the calculation of the royalties that
shall have accrued based upon such Revenues.
5.2 Payment
Terms. Royalties shown to have accrued by each royalty
report provided for under Section 5.1 above shall be due on the date such
royalty report is due.
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
5.3 Audits.
5.3.1 Upon
the written request of Licensor and not more than once in each
calendar year, Licensee and its Affiliates shall permit an
independent certified public accounting firm of nationally
recognized standing selected by Licensor and reasonably acceptable
to Licensee, at Licensor’s expense, to have access during
normal business hours to such of the financial records of Licensee
and its Affiliates as may be reasonably necessary to verify the
accuracy of the payment reports hereunder for the eight (8)
calendar quarters immediately prior to the date of such request
(other than records for which Licensor has already conducted an
audit under this Section).
5.3.2 If
such accounting firm concludes that additional amounts were owed
during the audited period, Licensee shall pay such additional
amounts within thirty (30) days after the date Licensor delivers to
Licensee such accounting firm’s written report so concluding.
The fees charged by such accounting firm shall be paid by Licensor;
provided, however, if the audit discloses that the royalties paid
by Licensee for such period were more than seven percent (7%) below
the royalties actually due and payable for such period, then
Licensee shall pay the reasonable fees and expenses charged by such
accounting firm.
5.3.3 Licensor
shall cause its accounting firm to retain all financial information
subject to review under this Section 5.3 in strict confidence; provided, however,
that Licensee shall have the right to require that such accounting
firm, prior to conducting such audit, enter into an appropriate
non-disclosure agreement with Licensee regarding such financial
information. The accounting firm shall disclose to Licensor only
whether the reports are correct or not and the amount of any
discrepancy. No other information shall be shared. Licensor shall
treat all such financial information as Licensee’s
Confidential Information
6. RESEARCH
AND DEVELOPMENT OBLIGATIONS
6.1 Research
and Development Efforts. Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to conduct such research, development and preclinical and
human clinical trials as Licensee reasonably determines are
necessary or desirable to obtain regulatory approval to manufacture
and market such Licensed Products as Licensee reasonably determines
are commercially feasible; and Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to obtain regulatory approval to market, and following
approval to commence marketing and to market each such Licensed
Product as Licensee reasonably determines are commercially
feasible.
6.2 R&D
Plan. Within three (3) months after the Effective Date,
Licensee shall furnish to Licensor a copy of Licensee’s
Research and Development Plan (“R&D Plan”) for
Licensed Products; and a status and progress report as to
Licensee’s implementation of the R&D Plan shall be
furnished to Licensor annually thereafter, together with an update
for the R&D Plan for the next year. The parties acknowledge
that the R&D Plan will represent the optimal and desired goals
and timeline for development of the Licensed Products, and that
there is no guarantee of achieving the goals within said
timeline.
6.3 Records.
Licensee shall maintain records, in sufficient detail and in good
scientific manner, which shall reflect all work done and results
achieved in the performance of its research and development
regarding the Licensed Products.
6.4 Reports.
By April 1 of each calendar year during the term of this
Agreement, Licensee shall prepare and deliver to Licensor a written
summary report which shall describe (a) the research performed
to date employing the Licensed IP, (b) the progress of the
development, and testing of Licensed Products in clinical trials,
and (c) the status of obtaining regulatory approvals to market
Licensed Products.
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
7. CONFIDENTIALITY
7.1 Confidential
Information. The reports finished by Licensee to Licensor
pursuant to Sections 4, 5 and 6 shall be treated as
Licensee’s Confidential Information. During the term of this
Agreement, and for a period of five (5) years following the
expiration or earlier termination hereof, Licensor shall maintain
in confidence all Confidential Information of Licensee that is
disclosed to Licensor, and shall not use, disclose or grant the use
of the Confidential Information except on a need-to-know basis to
those directors, officers, employees and agents, to the extent such
disclosure is reasonably necessary in connection with exercising
its rights under this Agreement.
7.2 Terms
of this Agreement. Except as otherwise required by
applicable laws, Licensor and Licensee shall not disclose any terms
or conditions of this Agreement to any Third Party without the
prior consent of the other Party. Notwithstanding the foregoing,
either Party may disclose the existence of this Agreement and the
general nature of the Licensed IP covered by this Agreement
(without disclosing any financial terms); and Licensee may disclose
the term of this Agreement to any existing or prospective investor
or business associate who has a need to know, subject to a
customary confidentiality agreement.
8. PATENTS
8.1 Patent
Prosecution and Maintenance. Licensee shall have the right
to control, at its sole cost, the preparation, filing, prosecution,
defense in post-grant and/or post issuance administrative
procedures, and maintenance of all patents and patent applications
in respect of Licensed Patents in the Territory and shall be solely
responsible for all prior and future costs incurred in the
preparation, filing, prosecution and maintenance of such patents
and patent applications from the Effective Date through the
termination of this Agreement. For further clarification, Licensee
shall reimburse Licensor (i) for costs incurred by UHN for the
preparation, filing, prosecution of Licensed IP prior to the
Effective Date (CAD$18,979.55 as of WS record on 6 Dec 2016),
pursuant to Section 4.2.2 hereof, and (ii) all reasonable costs
related to the future preparation, filing, prosecution, defense in
post-grant and/or post issuance administrative procedures, and
maintenance of all patents and patent applications in respect of
Licensed Patents, if any, incurred by UHN at Licensee’s
request after the Effective Date. All such applications in respect
of Licensed Patents shall be filed in the name of Licensor.
Licensee shall give Licensor an opportunity to review and comment
on the text of each patent application subject to this
Section 8.1 before filing, and
shall supply Licensor with a copy of such patent application as
filed, together with notice of its filing date and serial number.
Licensor shall cooperate with Licensee, execute all lawful papers
and instruments and make all rightful oaths and declarations as may
be necessary in the preparation, prosecution and maintenance of all
patents and other filings referred to in this Section 8.1. If Licensee, in its sole discretion,
decides to abandon the preparation, filing, prosecution or
maintenance of any patent or patent application in respect of
Licensed Patents, then Licensee shall notify Licensor in writing
thereof and following the date of such notice (a) Licensor
shall be responsible for and shall control, at its sole cost, the
preparation, filing, prosecution and maintenance of such patents
and patent applications, and (b) Licensee shall thereafter
have no license under this Agreement to such patent or patent
application.
8.2 Notification
of Infringement. Each Party shall notify the other Party of
any substantial infringement known to such Party of any Licensed
Patents and shall provide the other Party with the available
evidence, if any, of such infringement.
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|
|
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
8.3 Enforcement
of Patent Rights. Licensee, at its sole expense, shall have
the right to determine the appropriate course of action to enforce
Licensed Patents or otherwise xxxxx the infringement thereof, to
take (or refrain from taking) appropriate action to enforce
Licensed Patents, to defend any declaratory judgments seeking to
invalidate or hold the Licensed Patents unenforceable, to control
any litigation or other enforcement action and to enter into, or
permit, the settlement of any such litigation, declaratory
judgments or other enforcement action with respect to Licensed
Patents, in each case in Licensee’s own name and, if
necessary for standing purposes, in the name of Licensor and shall
consider, in good faith, the interests of Licensor in so doing. If
Licensee does not, within six (6) months after receipt of notice
from Licensor take reasonable steps to xxxxx the infringement or
file suit to enforce the Licensed Patents against at least one
infringing Party , Licensor shall have the right to take whatever
action it deems appropriate to enforce the Licensed Patents;
provided, however, that, within thirty (30) days after receipt of
notice of Licensor’s intent to file such suit, Licensee shall
have the right to jointly prosecute such suit and to fund up to
one-half (½) the costs of such suit. The Party controlling any
such joint enforcement action shall not settle the action or
otherwise consent to an adverse judgment in such joint action that
diminishes the rights or interests of the non-controlling Party
without the prior written consent of the other Party. All monies
recovered upon the final judgment or settlement of any such suit to
enforce the Licensed Patents shall be shared in relation to the
damages (including attorneys’ fees and expenses for the
enforcement action) incurred by each Party as a result of such
infringement; and such recovery shall not be treated as Revenues
for purposes of Section 4.2.1.
Notwithstanding the foregoing, to the extent any part of the
recovery includes a reasonable royalty payable to Licensee, such
royalty amounts shall be deemed Revenue on which Licensee will pay
a royalty to Licensor in accordance with Section 4.2.1.
8.4 Cooperation.
In any suit to enforce and/or defend the Licensed Patents pursuant
to this Section 8, the Party not
in control of such suit shall, at the request and expense of the
controlling Party, reasonably cooperate and, to the extent
possible, have its employees testify when requested and make
available relevant records, papers, information, samples,
specimens, and the like.
9. TERMINATION
9.1 Expiration.
Subject to Sections 9.3 and
9.4 below, this Agreement shall expire
on the expiration of Licensee’s obligation to make payments
to Licensor under Section 4
above. The license grant under Section 3.1 shall be effective at all times prior to
such expiration.
9.2 Termination
by Mutual Consent. The Parties may terminate this Agreement
at any time by mutual consent, which consent shall be evidenced by
a written agreement or other such documentation duly executed by
both Parties.
9.3 Termination
by Licensee. Licensee may terminate this Agreement, in its
sole discretion, upon thirty (30) days prior written notice to
Licensor, provided, however, Licensee shall remain liable for any
payments accrued under this Agreement prior to the date of
termination.
9.4 Termination
for Cause. Except as otherwise provided in
Section 11, Licensor may terminate
this Agreement upon or after the breach of any material provision
of this Agreement by Licensee, if Licensee has not cured such
breach within ninety (90) days after receipt of express written
notice thereof by Licensor; provided, however, if any default is
not capable of being cured within such ninety (90) day period and
Licensee is diligently undertaking to cure such default as soon as
commercially feasible thereafter under the circumstances, Licensor
shall have no right to terminate this Agreement.
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|
|
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
9.5 Termination
Upon Licensee Insolvency. This Agreement shall terminate at
least one day prior to the occurrence of any of the following
events: (i) the Licensee files a voluntary petition in bankruptcy
or insolvency or shall petition for reorganization under the
bankruptcy law, or makes a general assignment for the benefit of
creditors, or otherwise acknowledges insolvency or is adjudged
bankrupt; (ii) the Licensee consents to an involuntary petition in
bankruptcy or if a receiving order is given against it under any
applicable bankruptcy/insolvency law in a jurisdiction; (iii) the
appointment of a receiver or other similar representative for the
Licensee by a court of competent jurisdiction; or (iv) Licensee
fails to carry on business in the normal course.
9.6 Effect
of Expiration or Termination. Expiration or termination of
this Agreement shall not relieve the Parties of any obligation
accruing prior to such expiration or termination, and the
provisions of Sections 1, 2, 5, 7, 9.1, 9.6, 10 and 12 shall
survive the expiration or termination of this Agreement. Upon any
termination of this Agreement, Licensor shall grant a direct
license to any sublicense of Licensee hereunder having the same
scope as such sublicense and on terms and conditions no less
favorable to such Sublicensee than the terms and conditions of this
Agreement, provided that such Sublicensee is not in default of any
applicable obligations under this Agreement and agrees in writing
to be bound by the terms and conditions of such direct license.
Upon any termination of this Agreement, for a period of six
(6) months thereafter, Licensee (and its Affiliates and
Sublicensees) shall continue to be entitled to finish production of
any Products which were in process at the time of termination, and
Licensee (and its Affiliates and Sublicensees) shall be entitled to
sell all Products which were in inventory or in process at the time
of termination, so long as Licensee (and its Affiliates and
Sublicensees) continues to make the reports and pay the scheduled
royalties for said sales as set forth in this
Agreement.
10. INDEMNIFICATION
10.1 Indemnification.
Licensee shall defend, indemnify and hold Licensor (which for
purposes of clarity, is recognized to include, without limitation,
its directors, officers, employees, research trainees, students and
agents) harmless from all losses, liabilities, damages and expenses
(including attorneys’ fees and costs) incurred as a result of
any claim, demand, action or proceeding arising out of any breach
of this Agreement by Licensee, any damages or personal injury
resulting from the use, application of, distribution, sale or other
exploitation of the Licensed IP, Licensed Patents and the Licensed
Product by Licensee, its Affiliates or Sublicensees, or the gross
negligence or willful misconduct of Licensee in the performance of
its obligations under this Agreement, except in each case to the
extent arising from the gross negligence or willful misconduct of
Licensor or the breach of this Agreement by Licensor.
10.2 Procedure.
Licensor promptly shall notify Licensee of any liability or action
in respect of which Licensor intends to claim such indemnification,
and Licensee shall have the right to assume the defense thereof
with counsel selected by Licensee. The indemnity agreement in this
Section 10 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of
Licensee, which consent shall not be withheld unreasonably. The
failure to deliver notice to Licensee within a reasonable time
after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve Licensee of any
liability to Licensor under this Section 10, but the omission so to deliver notice to
Licensee will not relieve it of any liability that it may have to
Licensor otherwise than under this Section 10. Licensor under this Section 10, its employees and agents, shall cooperate
fully with Licensee and its legal representatives in the
investigation and defense of any action, claim or liability covered
by this indemnification.
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
10.3 Insurance.
During the term of this Agreement, Licensee shall maintain at its
own expense:
10.3.1 Comprehensive
general liability insurance for claims for damages arising from
bodily injury (including death) and property damages caused by, or
arising out of, acts or omissions of its employees, in such amounts
as are customary and reasonable in the Licensee’s
industry.
10.3.2 Product
liability insurance in such amounts as are customary and reasonable
in the Licensee’s industry.
10.3.3 Maintenance
of such insurance coverage shall not relieve Licensee of any
responsibility under this Agreement for damage in excess of the
insurance limits.
11. FORCE
MAJEURE
Neither
Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from Force Majeure events.
12. GENERAL
PROVISIONS
12.1 Notices.
Any consent, notice or report required or permitted to be given or
made under this Agreement by one Party to the other Party shall be
in writing, delivered by any available means to such other Party at
its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and
shall be effective upon receipt by the addressee.
If to
Licensor:
Director
University Health
Network
Office
of Technology Development & Commercialization
MaRS
Centre, Heritage Building
000
Xxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
If to
Licensee:
Chief Executive Officer
VistaGen
Therapeutics, Inc.
000
Xxxxxxxx Xxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
With
Copy to:
Xxxx
Xxxxx, Esq.
Law
Offices of Xxxx Xxxxx
0000
Xxxxxxx Xxxx
Xxxxx
000
Xxxxxxxx, XX
00000
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12.2 Further
Representations, Warranties & Liability.
(a) Licensee
represents and warrants to Licensor that Licensee has the power to
enter into this Agreement and to perform its obligations, and that
Licensee has taken necessary action for the execution of this
Agreement to constitute a binding obligation enforceable against
Licensee.
(b) Licensor
represents and warrants to Licensee that Licensor has the power to
enter into this Agreement and to perform its obligations, and that
Licensor has taken necessary action for the execution of this
Agreement to constitute a binding obligation enforceable against
Licensor.
(c) EXCEPT
AS EXPRESSLY PROVIDED IN THIS AGREEMENT, LICENSOR MAKES NO
CONDITIONS, WARRANTEES, UNDERTAKINGS OF ANY KIND, INCLUDING WITHOUT
LIMITATION, THE ORIGINALITY OR ACCURACY OR PATENTABILITY OR
VALIDITY OR NONINFRINGEMENT OF THE LICENSED PATENT(S), LICENSED IP,
OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT
MATTER OF, THIS AGREEMENT OR THE OWNERSHIP, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE OF THE LICENSED PATENT(S),
LICENSED IP, OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE
SUBJECT MATTER OF THIS AGREEMENT.
(d) LICENSOR
SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, OR
OTHER DAMAGES SUFFERED BY LICENSEE (AND ITS AFFILIATE(S) AND
SUBLICENSEES) OR ANY OTHERS RESULTING FROM THE USE OF THE OF THE
LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S) ARISING
UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT. THE
ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, USE, EXPLOITATION,
MANUFACTURE, SALE OR OTHER DISPOSITION AND PERFORMANCE IN RESPECT
OF THE LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S)
ARISING UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT IS
ASSUMED BY LICENSEE.
12.3 Dispute
Resolution.
(a) The
Parties agree to use reasonable best efforts to amicably resolve
among themselves any dispute arising out of this
Agreement.
(b) If
the Parties are unable to resolve the dispute under Section 8.5(a),
the dispute shall be referred to the Vice President, Research of
Licensor or the Vice President’s designate and the designate
of Licensee for their discussion and resolution. The Parties may
agree to mediation of the dispute (procedural details and process
to be determined by the Parties).
(c) Any
dispute which cannot be amicably settled by the Parties as provided
in Sections 8.5(a) and (b) shall be submitted to arbitration in
accordance with the provisions of the (Ontario) Arbitration Act,
1991, S.O. 1991, c.17, as amended from time to time. The
arbitration will take place in the city of Toronto (Ontario,
Canada).
(d) Notwithstanding
the foregoing, either Party shall have the right, without waiving
any right or remedy available to such Party under this Agreement or
otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending
the selection of the mediator(s) or arbitrator(s) hereunder, or
pending the mediator(s)’ or arbitrator(s)’
determination of any dispute, controversy or claim
hereunder.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12.4 Assignment.
Licensee shall not assign its rights or obligations under this
Agreement without the prior written consent of Licensor;
provided,
however, that
Licensee may, without such consent, assign this Agreement and its
rights and obligations hereunder (a) to any Affiliate, or
(b) in connection with the transfer or sale of all or
substantially all of its business to which this Agreement relates,
or in the event of its merger, consolidation, change in control or
similar transaction. Notwithstanding the aforementioned, Licensee
shall remain responsible for the performance of all obligations
under this Agreement (including, without limitation, the payment of
royalties to Licensor).
12.5 Waivers
and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions
herein contained, shall be valid unless made in writing and signed
by duly authorized representatives of the parties
hereto.
12.6 Entire
Agreement. This Agreement embodies the entire agreement
between the parties and supersedes any prior representations,
understandings and agreements between the parties regarding the
subject matter hereof. There are no representations, understandings
or agreements, oral or written, between the parties regarding the
subject matter hereof that are not fully expressed
herein.
12.7 Severability.
Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective
to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the
remaining provisions hereof and without affecting the validity or
enforceability of any of the terms of this Agreement in any other
jurisdiction.
12.8 Waiver.
The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or
otherwise.
12.9 Counterparts.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Evidence of the execution
and delivery of this Agreement may be by a telecopy transmission to
a Party of the other Party’s signed copy of this
Agreement.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
IN
WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date.
LICENSOR:
University of Health Network
By:
/s/ Xxxxxx X.
Xxxxxxx
Name:
Xxxxxx X. Xxxxxxx, PhD
Title:
Executive VP, Science & Research
LICENSEE:
VistaGen Therapeutics, Inc.
By:
/s/ Xxxxx X.
Xxxxx
Name:
Xxxxx X. Xxxxx, XX
Title:
Chief Executive Officer
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
A
DEFINITIONS
“Affiliate”
shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
“Confidential
Information” shall mean, with respect to a Party, all
information (and all tangible and intangible embodiments thereof),
that is owned or controlled by such Party, is disclosed by or on
behalf of such Party to the other Party pursuant to this Agreement,
and (if disclosed in writing or other tangible medium) is marked or
identified as confidential at the time of disclosure to the
receiving Party or (if otherwise disclosed) is identified as
confidential at the time of disclosure to the receiving Party and
described as such in writing within thirty (30) days after such
disclosure. Notwithstanding the foregoing, Confidential Information
of a Party shall not include information which, and only to the
extent the receiving Party can establish by written documentation,
(a) has been generally known prior to disclosure of such
information by the disclosing Party to the receiving Party;
(b) has become generally known, without the fault of the
receiving Party, subsequent to disclosure of such information by
the disclosing Party to the receiving Party; (c) has been
received by the receiving Party at any time from a source other
than the disclosing Party, rightfully having possession of and the
right to disclose such information free of confidentiality
obligations; (d) has been otherwise known by the receiving
Party free of confidentiality obligations prior to disclosure of
such information by the disclosing Party to the receiving Party; or
(e) has been independently developed by employees or others on
behalf of the receiving Party without use of such information
disclosed by the disclosing Party to the receiving Party (each of
the aforementioned (a) to (e) a “Confidentiality
Exception”).
“Effective
Date” shall have the meaning set forth in the preamble
to this Agreement.
“FDA”
shall mean the Food and Drug Administration of the United States,
or the successor thereto, or
its foreign equivalent in Canada, the EU or elsewhere.
“Force
Majeure” means an event or circumstance arising
outside of the reasonable control of a party, such as any act of
God, flood, natural disaster, embargo, acts of civil or military
authorities, terrorism, labor strikes, governmental embargos, and
governmental orders.
“IND”
shall mean an investigational new drug application or similar
application which is required to be filed with the FDA prior to
commencing a clinical investigation of a drug pursuant to (US) 21
C.F.R. 312, or its foreign
equivalent in Canada, the EU or elsewhere.
“Intellectual
Property” or “IP” shall mean all
inventions (whether or not patentable), discoveries, trade secrets,
Confidential Information, Know-How, data, technology, formulae,
methods, processes, protocols, techniques, compositions, and other
protectable intangible rights, together with all related Patent
Rights, copyrights, trade secret rights, and other legally
enforceable rights.
“Know-How”
shall mean all trade secrets, know-how, data, information,
compositions and other technology (including, but not limited to,
formulae, procedures, protocols, techniques and results of
experimentation and testing) which are necessary or useful to make,
use, develop, sell or seek regulatory approval to market a
composition, or to practice any method or process, at any time
claimed or disclosed in any issued patent or pending patent
application directly and specifically applicable to the Licensed
Patents, the Licensed IP, or the Licensed Products.
“Licensed
IP” shall have the meaning as defined in Exhibit
B.
“Licensed
Patents” shall mean the Patent Rights applicable to
the Licensed IP.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
“Licensed
Product(s)” shall mean any product or service that if
made, used, provided, offered to be provided, sold, offered for
sale or imported would infringe (but for the License Agreement) a
Valid Claim of the Licensed Patents, or that otherwise uses or
incorporates the Licensed IP.
“Milestone
Event” shall have the meaning as defined in
Section 4.1.
“Milestone
Payment” shall have the meaning as defined in
Section 4.1.
“NDA”
shall mean a New Drug Application, or similar application for
marketing approval of a Product for use in the Field submitted to
the FDA, or its foreign
equivalent in Canada, the EU or elsewhere.
“Net
Sales” shall mean, with respect to any
Therapeutic-Related Licensed Product, the gross sales price of such
Therapeutic-Related Licensed Product invoiced by Licensee or its
Affiliates to customers who are not Affiliates (or are Affiliates
but are the end users of such Therapeutic-Related Licensed Product)
less, to the extent actually paid or accrued by License or its
Affiliate (as applicable), (a) reasonable credits, allowances,
discounts and rebates to, and chargebacks from the account of, such
customers for nonconforming, damaged, out-dated and returned
Therapeutic-Related Licensed Product; (b) freight and
insurance costs incurred by License or its Affiliate (as
applicable) in transporting such Therapeutic-Related Licensed
Product to such customers; (c) reasonable cash, quantity and
trade discounts, rebates and other price reductions for such
Therapeutic-Related Licensed Product given to such customers under
price reduction programs; (d) sales, use, value-added and
other direct taxes incurred on the sale of such Therapeutic-Related
Licensed Product to such customers; (e) customs duties,
tariffs, surcharges and other governmental charges incurred in
exporting or importing such Therapeutic-Related Licensed Product to
such customers; and (f) a reasonable allowance for uncollectible or
bad debts determined in accordance with generally accepted
accounting principles.
“Party”
shall mean either VistaGen or UHN; and “Parties” shall mean both
VistaGen and UHN.
“Patent
Rights” shall mean (a) all patents and patent
applications worldwide describing the Licensed IP listed on Exhibit
B hereto, (b) all divisions, continuations,
continuations-in-part, that claim priority to, or common priority
with, the patent applications listed in clause (a) above or the
patent applications that resulted in the patents described in
clause (a) above, and (c) all patents that have issued or in
the future issue from any of the foregoing patent applications,
including utility, model and design patents and certificates of
invention, together with any reissues, renewals, extensions or
additions thereto worldwide.
“Person”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
“Phase I
Clinical Trial” shall mean a human clinical trial that
is intended to initially evaluate the safety and/or pharmacological
effect of a Product in subjects or that would otherwise satisfy
requirements of (US) 21 C.F.R. 312.21(a), or its foreign equivalent in Canada, the
EU or elsewhere.
“Phase II
Clinical Trial” shall mean a human clinical trial in
any country that is intended to initially evaluate the
effectiveness of a Product for a particular indication or
indications in patients with the disease or indication under study
or would otherwise satisfy requirements of (US)
21 C.F.R. 312.21(b), or its foreign equivalent in Canada, the
EU or elsewhere.
“Phase III
Clinical Trial” shall mean a human clinical trial in
any country, the results of which could be used to establish safety
and efficacy of a Product as a basis for an NDA or would otherwise
satisfy requirements of (US) 21 C.F.R. 312.21(c),
or its foreign equivalent in
Canada, the EU or elsewhere.
“Revenues”
shall mean (i) Net Sales on a country-by-country basis of
Therapeutic-Related Licensed Product(s) sold by Licensee and its
Affiliates on a country-by-country basis, (ii) Sublicensing
Consideration received by Licensee and its Affiliates from
Sublicense Agreements, and (iii) Service Sales on a
country-by-country basis in respect of Service-Related Licensed
Product(s).
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
“Service-Related
Licensed Product” shall mean a Licensed Product (i)
that is used in and/or for the provision of a research, development
or other service to a third party, or (ii) for use in, or as part
of, a diagnostic kit or service.
“Service
Sales” shall mean, with respect to any Service-Related
Licensed Product, the gross amount of monies received for,
associated with, or in respect of Service-Related Licensed
Product(s) invoiced by Licensee or its Affiliates to customers or
otherwise to third parties who are not Affiliates (or are
Affiliates but are the end users, beneficiaries, or otherwise
recipients of such Service-Related Licensed Product(s)) less, to
the extent actually paid or accrued by License or its Affiliate (as
applicable), (a) reasonable credits, allowances, discounts and
rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Service-Related
Licensed Product; (b) freight and insurance costs incurred by
License or its Affiliate (as applicable) in transporting such
Service-Related Licensed Product to such customers;
(c) reasonable cash, quantity and trade discounts, rebates and
other price reductions for such Service-Related Licensed Product
given to such customers under price reduction programs;
(d) sales, use, value-added and other direct taxes incurred on
the sale of such Service-Related Licensed Product to such
customers; (e) customs duties, tariffs, surcharges and other
governmental charges incurred in exporting or importing such
Service-Related Licensed Product to such customers; and (f) a
reasonable allowance for uncollectible or bad debts determined in
accordance with generally accepted accounting
principles.
“Sublicense
Agreement” shall mean any agreement or commitment
pursuant to which any of the rights of Licensee under this
Agreement are sublicensed or otherwise extended, granted or given
to a Third Party (a Sublicensee).
“Sublicensee”
shall mean any Third Party to whom Licensee (or its Affiliates)
grants rights to use some of Licensee’s rights under this
Agreement.
“Sublicensing
Consideration” shall mean the aggregate consideration
received by Licensee or its Affiliates in consideration for
granting sublicense rights to a Sublicensee under the Licensed IP,
including without limitation license fees, milestone fees, minimum
royalties, and earned royalties, but excluding (a) amounts
received to fund or reimburse Licensee’s or its
Affiliates’ cost to perform research, development or similar
services specifically and directly associated with Licensed
Products, (b) amounts received in reimbursement of Licensed IP
patent or other Licensed IP-related out-of-pocket expenses
specifically and directly associated with Licensed Products; and
(c) amounts received in consideration for the sale of any debt
or securities of Licensee or its Affiliates.
“Therapeutic-Related
Licensed Product” shall mean a Licensed Product that
forms a constituent part of a therapeutic agent for use in human
medical or veterinary purposes.
“Third
Party” shall mean any Person other than Licensor,
Licensee and their respective Affiliates.
“Valid
Claim” shall mean a claim of an issued and unexpired
patent included within the Licensed Patent, which has not been held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
B
LICENSED IP
[*****].
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE
D
LICENSE
AGREEMENT NUMBER FOUR
(See
attached)
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
SCHEDULE D
LICENSE
AGREEMENT
dated
as of December 9, 2016
between
UNIVERSITY
HEALTH NETWORK,
(as
“Licensor”)
and
VISTAGEN
THERAPEUTICS, INC.
(as
“Licensee”)
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
1.
DEFINITIONS
2.
REPRESENTATIONS AND
WARRANTIES
2.1
Mutual
Representations and Warranties
2.2
Licensor
Representations and Warranties
3.
LICENSE
GRANT
3.1
Licensed
IP
3.2
Availability of the
Licensed IP
3.3
Reserved
Right
4.
FINANCIAL
CONSIDERATIONS
4.1
Development-Based
Milestone Payments
4.2
Licensing Fees and
Royalties
5.
ROYALTY REPORTS,
PAYMENTS, AND ACCOUNTING
5.1
Royalty
Reports
5.2
Payment
Terms
5.3
Audits
6.
RESEARCH AND
DEVELOPMENT OBLIGATIONS
6.1
Research and
Development Efforts
6.2
R&D
Plan
6.3
Records
6.4
Reports
7.
CONFIDENTIALITY
7.1
Confidential
Information
7.2
Terms of this
Agreement
8.
PATENTS
8.1
Patent Prosecution
and Maintenance
8.2
Notification of
Infringement
8.3
Enforcement of
Patent Rights
8.4
Cooperation
9.
TERMINATION
9.1
Expiration
9.2
Termination by
Mutual Consent
9.3
Termination by
Licensee
9.4
Termination for
Cause
9.5
Termination Upon
Licensee Insolvency
9.6
Effect of
Expiration or Termination
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
TABLE
OF CONTENTS
(continued)
10.
INDEMNIFICATION
10.1
Indemnification
10.2
Procedure
10.3
Insurance
11.
FORCE
MAJEURE
12.
GENERAL
PROVISIONS
12.1
Notices
12.2
Further
Representations, Warranties & Liability
12.3
Dispute
Resolution.
12.4
Assignment
12.5
Waivers and
Amendments
12.6
Entire
Agreement
12.7
Severability
12.8
Waiver
12.9
Counterparts
EXHIBITS
EXHITIB
A DEFINITIONS
EXIBIT
B LICENSED IP
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
LICENSE
AGREEMENT
THIS
LICENSE AGREEMENT NUMBER 5 (this “Agreement”) is dated
as of December 9, 2016 (the
“Effective
Date”), and is entered into by and between
(i) University Health Network, an Ontario corporation,
incorporated under the University
Health Network Xxx 0000 (“Licensor”), having a
business office at MaRS Centre (Heritage Building), 000 Xxxxxxx
Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxx X0X 0X0, Xxxxxx, and
(ii) VistaGen Therapeutics, Inc., a California corporation
(“Licensee”), having a
place of business at 000 Xxxxxxxx Xxx, Xxxxx Xxx Xxxxxxxxx, XX
00000.
WHEREAS, Licensor
owns or has rights in the Licensed IP (as defined in Exhibit
B).
WHEREAS, Licensee
desires to obtain an exclusive license under Licensor’s
rights in the Technology on the terms and conditions set forth
below.
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:
For
purposes of this Agreement, the terms defined in Exhibit A
shall have the defined meanings set forth in Exhibit A. Unless
otherwise noted, all dollar amounts are quoted in US
dollars.
2. REPRESENTATIONS
AND WARRANTIES
2.1. Mutual
Representations and Warranties. Each Party hereby represents
and warrants to the other Party as follows:
2.1.1. Such
Party is a corporation duly organized, validly existing and in good
standing under the laws of the state, province or country in which
it is incorporated.
2.1.2. Such
Party (a) has the corporate power and authority and the legal
right to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against
such Party in accordance with its terms.
2.1.3. All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such Party in connection with entering into this this Agreement
have been obtained.
2.1.4. The
execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder (a) do not conflict with
or violate any requirement of applicable laws or regulations, and
(b) do not conflict with, or constitute a default under, any
contractual obligation of it.
___________________
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
2.2. Licensor
Representations and Warranties. Licensor hereby represents
and warrants to Licensee that, as of the Effective Date, Licensor,
to the best of its knowledge, (a) is the sole owner of the Licensed
IP, and (b) other than as noted in Exhibit C, has not granted to
any Third Party any license or other interest in the Licensed IP,
and (c) is not aware of any Third Party patent, patent
application or other intellectual property rights (other than any
inventions identified as prior art in the patents or patent
applications licensed to Licensee hereunder) that would be
infringed (i) by practicing any process or method or by
making, using or selling any composition which is claimed or
disclosed in the Licensed IP, or (ii) by making, using or
selling Licensed Products (but only to the extent that the making,
using or selling of Licensed Products is covered by Licensed IP),
and (d) is not aware of any infringement or misappropriation
by a Third Party of the Licensed IP. Notwithstanding the foregoing,
Licensor is under no duty , obligation or requirement to perform or
conduct any legal inquiry or other search, analyses or assessment
pertaining to patentability, validity, infringement and/or legal
status in respect of any Licensed IP and Licensed
Patents.
3. LICENSE
GRANT
3.1. Licensed IP. Subject to Section
3.3, Licensor hereby grants to Licensee an exclusive license (with
the right to grant sublicenses through multiple tiers) under the
Licensed IP to conduct research and to develop, make, have made,
use, offer for sale, sell and import Licensed Products, worldwide
and for all fields of use. Licensee shall promptly provide to
Licensor a copy of any Sublicense Agreement. The grant of any such
Sublicense Agreement will not relieve Licensee of its obligations
under this Agreement.
3.2. Availability
of the Licensed IP. Within ten (10) days of the Effective
Date, Licensor shall provide Licensee with a copy of all
information and documents available to Licensor relating to the
filing and prosecution of patent applications encompassing the
Licensed IP.
3.3. Reserved
Right. Licensor reserves and retains the non-exclusive,
sublicenseable right to use the Licensed IP for non-commercial
research purposes and/or academic educational purposes, without any
financial obligation to Licensee for so using the Licensed
IP.
4.1. Development-Based
Milestone Payments. At such time as Licensee (or its
Affiliates or Sublicensees) achieve a Milestone Event as described
below for a specific Licensed Product, Licensee shall pay to
Licensor the Milestone Payment specified below. The specified
milestone payment shall be made within thirty (30) days after the
occurrence of the Milestone Event.
___________________
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|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
|
A.
|
|
“Milestone
Event” for Therapeutic-Related Licensed Product
*
|
“Milestone
Payment” (US$)
|
|
|
(1)
|
Acceptance
by FDA (first country) of filing of IND
|
$150,000
|
|
|
(2)
|
First
patient enrolled for Phase II Clinical Trial
|
$250,000
|
|
|
(3)
|
First
patient enrolled for Phase III Clinical Trial
|
$1,500,000
|
|
|
(4)
|
FDA
(first country) Final Approval of NDA for Licensed
Product
|
$2,000,000
|
|
B.
|
|
“Milestone
Event” for Service-Related Licensed Product
|
“Milestone
Payment” (US$)
|
|
|
(1)
|
First
anniversary of execution of an agreement in respect of (in whole or
in part) a Service-Related Licensed Product.
|
$50,000
**
|
For the
purpose of this Section 4.1 “Final Approval” shall
mean approval by the FDA for marketing a Therapeutic-Related
Licensed Product that is not conditioned on any other event (or if
an approval is conditioned upon an event, then the occurrence of
that event), provided, however, such other events shall
specifically not include FDA requirements to conduct post marketing
studies and any requirement for such post marketing studies shall
not be deemed to delay the Final Approval.
* Once
a Milestone Payment has been made for a specific Licensed Product,
if there are later modifications, improvements, reformulations,
combinations, or other changes using the same molecule which
constitutes said Licensed Product (i.e., a “Related Product”), then
no duplicate Milestone Payment will be owed when that Related
Product achieves the same Milestone Event for which the Milestone
Payment was previously made for said specific Licensed Product.
Similarly, if there is a failure in product development, resulting
in the substitutionor replacement of the failed molecule with a new
molecule, to the extent that a Milestone Event had previously been
achieved by the failed molecule and the corresponding Milestone
Payment paid, then no duplicate Milestone Payment will be owed when
the new molecule achieves the same Milestone Event for which the
Milestone Payment was previously made for the failed
molecule.
** But
not more than 10% of the annual revenues received from said
agreement, continuing annually until the cumulative aggregate of
said 10% payments reach US$50,000.
___________________
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
4.2. Licensing
Fees and Royalties.
4.2.1. Upfront License Fee. On the
Effective Date, Licensee shall pay to UHN a one-time upfront
non-refundable License Fee of Twenty Five Thousand Dollars
(US$25,000).
4.2.2. Patent
Reimbursement. On the Effective Date, Licensee shall
reimburse UHN a total of (i) patent costs (if any) related to the
Licensed IP incurred by UHN prior to the Effective Date and (ii)
such patent costs reasonably incurred by UHN, if any, after the
Effective Date and prior to six (6) months from the Effective Date,
in each case as provided under subsection 8.1 below.
4.2.3. Royalty
Rate. Licensee shall pay to Licensor three percent (3%) of
the first US$25 million of cumulative Revenues received by
Licensee or its Affiliates, and two percent (2%) of all additional
cumulative Revenues received by Licensee or its Affiliates, subject
to reductions pursuant to Sections 4.2.4 and
4.2.5.
4.2.4. Third
Party Royalties. If Licensee or its Affiliates is required
to pay royalties to any Third Party that are, in the opinion of an
independent patent attorney (reasonably acceptable to both
parties), necessary to practice the inventions claimed in the
Licensed IP, then Licensee shall have the right to credit such
Third Party royalty payments against the royalties owing to
Licensor under Section 4.2.3;provided, however, that the foregoing
credits shall not reduce the amount of the royalties payable to
Licensor under Section 4.2.3 above by more than fifty percent
(50%).
4.2.5. Combination
Products. If a Product consists of (i) components that are
covered by Licensor’s Valid Claims, plus (ii) additional
active pharmaceutical agents, or functional components reasonable
necessary for formulation or delivery of the Product that are not
covered by a Valid Claim, but that are covered by a valid claim of
a Third Party patent, then for purposes of the royalty payments
under Section 4.2.3, the Revenues shall be equitably allocated
between the components covered by Licensor’s Valid Claim and
the components covered by the Third Party patent, with only the
portion of Revenues allocated to Licensor’s Valid Claims
being used for purposes of the royalty calculation in
Section 4.2.3 for such combination Product. To the extent the
parties are unable to agree on the equitable allocation described
above, any dispute shall be resolved in accordance with Section
12.3 of this Agreement. Notwithstanding the aforementioned, the
foregoing allocation shall not reduce the amount of the royalties
payable to Licensor under Section 4.2.3 above by more than
fifty percent (50%).
5. ROYALTY
REPORTS, PAYMENTS, AND ACCOUNTING
5.1. Royalty Reports. Within sixty
(60) days after the end of each calendar year during the term of
this Agreement following the receipt by Licensee or its Affiliates
of Revenues, Licensee shall furnish to Licensor a quarterly written
report showing in reasonably specific detail (a) the
calculation of Revenues for such quarter; and (b) the
calculation of the royalties that shall have accrued based upon
such Revenues.
5.2. Payment
Terms. Royalties shown to have accrued by each royalty
report provided for under Section 5.1 above shall be due on the date such
royalty report is due.
___________________
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|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
5.3. Audits.
5.3.1. Upon
the written request of Licensor and not more than once in each
calendar year, Licensee and its Affiliates shall permit an
independent certified public accounting firm of nationally
recognized standing selected by Licensor and reasonably acceptable
to Licensee, at Licensor’s expense, to have access during
normal business hours to such of the financial records of Licensee
and its Affiliates as may be reasonably necessary to verify the
accuracy of the payment reports hereunder for the eight (8)
calendar quarters immediately prior to the date of such request
(other than records for which Licensor has already conducted an
audit under this Section).
5.3.2. If
such accounting firm concludes that additional amounts were owed
during the audited period, Licensee shall pay such additional
amounts within thirty (30) days after the date Licensor delivers to
Licensee such accounting firm’s written report so concluding.
The fees charged by such accounting firm shall be paid by Licensor;
provided, however, if the audit discloses that the royalties paid
by Licensee for such period were more than seven percent (7%) below
the royalties actually due and payable for such period, then
Licensee shall pay the reasonable fees and expenses charged by such
accounting firm.
5.3.3. Licensor
shall cause its accounting firm to retain all financial information
subject to review under this Section 5.3 in strict confidence;
provided, however, that Licensee shall have the right to require
that such accounting firm, prior to conducting such audit, enter
into an appropriate non-disclosure agreement with Licensee
regarding such financial information. The accounting firm shall
disclose to Licensor only whether the reports are correct or not
and the amount of any discrepancy. No other information shall be
shared. Licensor shall treat all such financial information as
Licensee’s Confidential Information
6. RESEARCH
AND DEVELOPMENT OBLIGATIONS
6.1. Research
and Development Efforts. Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to conduct such research, development and preclinical and
human clinical trials as Licensee reasonably determines are
necessary or desirable to obtain regulatory approval to manufacture
and market such Licensed Products as Licensee reasonably determines
are commercially feasible; and Licensee (together with its
Affiliates and Sublicensees) shall use its commercially reasonable
efforts to obtain regulatory approval to market, and following
approval to commence marketing and to market each such Licensed
Product as Licensee reasonably determines are commercially
feasible.
6.2. R&D
Plan. Within three (3) months after the Effective Date,
Licensee shall furnish to Licensor a copy of Licensee’s
Research and Development Plan (“R&D Plan”) for
Licensed Products; and a status and progress report as to
Licensee’s implementation of the R&D Plan shall be
furnished to Licensor annually thereafter, together with an update
for the R&D Plan for the next year. The parties acknowledge
that the R&D Plan will represent the optimal and desired goals
and timeline for development of the Licensed Products, and that
there is no guarantee of achieving the goals within said
timeline.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
-95-
Exclusive License and Sublicense Agreement
6.3. Records.
Licensee shall maintain records, in sufficient detail and in good
scientific manner, which shall reflect all work done and results
achieved in the performance of its research and development
regarding the Licensed Products.
6.4. Reports.
By April 1 of each calendar year during the term of this
Agreement, Licensee shall prepare and deliver to Licensor a written
summary report which shall describe (a) the research performed
to date employing the Licensed IP, (b) the progress of the
development, and testing of Licensed Products in clinical trials,
and (c) the status of obtaining regulatory approvals to market
Licensed Products.
7. CONFIDENTIALITY
7.1. Confidential
Information. The reports finished by Licensee to Licensor
pursuant to Sections 4, 5 and 6 shall be treated as
Licensee’s Confidential Information. During the term of this
Agreement, and for a period of five (5) years following the
expiration or earlier termination hereof, Licensor shall maintain
in confidence all Confidential Information of Licensee that is
disclosed to Licensor, and shall not use, disclose or grant the use
of the Confidential Information except on a need-to-know basis to
those directors, officers, employees and agents, to the extent such
disclosure is reasonably necessary in connection with exercising
its rights under this Agreement.
7.2. Terms
of this Agreement. Except as otherwise required by
applicable laws, Licensor and Licensee shall not disclose any terms
or conditions of this Agreement to any Third Party without the
prior consent of the other Party. Notwithstanding the foregoing,
either Party may disclose the existence of this Agreement and the
general nature of the Licensed IP covered by this Agreement
(without disclosing any financial terms); and Licensee may disclose
the term of this Agreement to any existing or prospective investor
or business associate who has a need to know, subject to a
customary confidentiality agreement.
8.1. Patent Prosecution and
Maintenance. Licensee shall have the right to control, at
its sole cost, the preparation, filing, prosecution, defense in
post-grant and/or post issuance administrative procedures, and
maintenance of all patents and patent applications in respect of
Licensed Patents in the Territory and shall be solely responsible
for all prior and future costs incurred in the preparation, filing,
prosecution and maintenance of such patents and patent applications
from the Effective Date through the termination of this Agreement.
For further clarification, Licensee shall reimburse Licensor (i)
for any costs incurred by UHN for the preparation, filing,
prosecution of Licensed IP prior to the Effective Date, pursuant to
Section 4.2.2 hereof, and (ii) all reasonable costs related to the
future preparation, filing, prosecution, defense in post-grant
and/or post issuance administrative procedures, and maintenance of
all patents and patent applications in respect of Licensed Patents,
if any, incurred by UHN at Licensee’s request after the
Effective Date. All such applications in respect of Licensed
Patents shall be filed in the name of Licensor. Licensee shall give
Licensor an opportunity to review and comment on the text of each
patent application subject to this Section 8.1 before filing, and shall supply Licensor
with a copy of such patent application as filed, together with
notice of its filing date and serial number. Licensor shall
cooperate with Licensee, execute all lawful papers and instruments
and make all rightful oaths and declarations as may be necessary in
the preparation, prosecution and maintenance of all patents and
other filings referred to in this Section 8.1. If Licensee, in its sole discretion,
decides to abandon the preparation, filing, prosecution or
maintenance of any patent or patent application in respect of
Licensed Patents, then Licensee shall notify Licensor in writing
thereof and following the date of such notice (a) Licensor
shall be responsible for and shall control, at its sole cost, the
preparation, filing, prosecution and maintenance of such patents
and patent applications, and (b) Licensee shall thereafter
have no license under this Agreement to such patent or patent
application.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
8.2. Notification
of Infringement. Each Party shall notify the other Party of
any substantial infringement known to such Party of any Licensed
Patents and shall provide the other Party with the available
evidence, if any, of such infringement.
8.3. Enforcement
of Patent Rights. Licensee, at its sole expense, shall have
the right to determine the appropriate course of action to enforce
Licensed Patents or otherwise xxxxx the infringement thereof, to
take (or refrain from taking) appropriate action to enforce
Licensed Patents, to defend any declaratory judgments seeking to
invalidate or hold the Licensed Patents unenforceable, to control
any litigation or other enforcement action and to enter into, or
permit, the settlement of any such litigation, declaratory
judgments or other enforcement action with respect to Licensed
Patents, in each case in Licensee’s own name and, if
necessary for standing purposes, in the name of Licensor and shall
consider, in good faith, the interests of Licensor in so doing. If
Licensee does not, within six (6) months after receipt of notice
from Licensor take reasonable steps to xxxxx the infringement or
file suit to enforce the Licensed Patents against at least one
infringing Party , Licensor shall have the right to take whatever
action it deems appropriate to enforce the Licensed Patents;
provided, however, that, within thirty (30) days after receipt of
notice of Licensor’s intent to file such suit, Licensee shall
have the right to jointly prosecute such suit and to fund up to
one-half (½) the costs of such suit. The Party controlling any
such joint enforcement action shall not settle the action or
otherwise consent to an adverse judgment in such joint action that
diminishes the rights or interests of the non-controlling Party
without the prior written consent of the other Party. All monies
recovered upon the final judgment or settlement of any such suit to
enforce the Licensed Patents shall be shared in relation to the
damages (including attorneys’ fees and expenses for the
enforcement action) incurred by each Party as a result of such
infringement; and such recovery shall not be treated as Revenues
for purposes of Section 4.2.1.
Notwithstanding the foregoing, to the extent any part of the
recovery includes a reasonable royalty payable to Licensee, such
royalty amounts shall be deemed Revenue on which Licensee will pay
a royalty to Licensor in accordance with Section 4.2.1.
8.4. Cooperation.
In any suit to enforce and/or defend the Licensed Patents pursuant
to this Section 8, the Party not
in control of such suit shall, at the request and expense of the
controlling Party, reasonably cooperate and, to the extent
possible, have its employees testify when requested and make
available relevant records, papers, information, samples,
specimens, and the like.
9. TERMINATION
9.1. Expiration.
Subject to Sections 9.3 and 9.4
below, this Agreement shall expire on the expiration of
Licensee’s obligation to make payments to Licensor under
Section 4 above. The license
grant under Section 3.1 shall be
effective at all times prior to such expiration.
9.2. Termination
by Mutual Consent. The Parties may terminate this Agreement
at any time by mutual consent, which consent shall be evidenced by
a written agreement or other such documentation duly executed by
both Parties.
9.3. Termination by Licensee.
Licensee may terminate this Agreement, in its sole discretion, upon
thirty (30) days prior written notice to Licensor, provided,
however, Licensee shall remain liable for any payments accrued
under this Agreement prior to the date of termination.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
9.4. Termination
for Cause. Except as otherwise provided in
Section 11, Licensor may terminate
this Agreement upon or after the breach of any material provision
of this Agreement by Licensee, if Licensee has not cured such
breach within ninety (90) days after receipt of express written
notice thereof by Licensor; provided, however, if any default is
not capable of being cured within such ninety (90) day period and
Licensee is diligently undertaking to cure such default as soon as
commercially feasible thereafter under the circumstances, Licensor
shall have no right to terminate this Agreement.
9.5. Termination
Upon Licensee Insolvency. This Agreement shall terminate at
least one day prior to the occurrence of any of the following
events: (i) the Licensee files a voluntary petition in bankruptcy
or insolvency or shall petition for reorganization under the
bankruptcy law, or makes a general assignment for the benefit of
creditors, or otherwise acknowledges insolvency or is adjudged
bankrupt; (ii) the Licensee consents to an involuntary petition in
bankruptcy or if a receiving order is given against it under any
applicable bankruptcy/insolvency law in a jurisdiction; (iii) the
appointment of a receiver or other similar representative for the
Licensee by a court of competent jurisdiction; or (iv) Licensee
fails to carry on business in the normal course.
9.6. Effect
of Expiration or Termination. Expiration or termination of
this Agreement shall not relieve the Parties of any obligation
accruing prior to such expiration or termination, and the
provisions of Sections 1, 2, 5, 7, 9.1, 9.6, 10 and 12 shall
survive the expiration or termination of this Agreement. Upon any
termination of this Agreement, Licensor shall grant a direct
license to any sublicense of Licensee hereunder having the same
scope as such sublicense and on terms and conditions no less
favorable to such Sublicensee than the terms and conditions of this
Agreement, provided that such Sublicensee is not in default of any
applicable obligations under this Agreement and agrees in writing
to be bound by the terms and conditions of such direct license.
Upon any termination of this Agreement, for a period of six
(6) months thereafter, Licensee (and its Affiliates and
Sublicensees) shall continue to be entitled to finish production of
any Products which were in process at the time of termination, and
Licensee (and its Affiliates and Sublicensees) shall be entitled to
sell all Products which were in inventory or in process at the time
of termination, so long as Licensee (and its Affiliates and
Sublicensees) continues to make the reports and pay the scheduled
royalties for said sales as set forth in this
Agreement.
10.1. Indemnification.
Licensee shall defend, indemnify and hold Licensor (which for
purposes of clarity, is recognized to include, without limitation,
its directors, officers, employees, research trainees, students and
agents) harmless from all losses, liabilities, damages and expenses
(including attorneys’ fees and costs) incurred as a result of
any claim, demand, action or proceeding arising out of any breach
of this Agreement by Licensee, any damages or personal injury
resulting from the use, application of, distribution, sale or other
exploitation of the Licensed IP, Licensed Patents and the Licensed
Product by Licensee, its Affiliates or Sublicensees, or the gross
negligence or willful misconduct of Licensee in the performance of
its obligations under this Agreement, except in each case to the
extent arising from the gross negligence or willful misconduct of
Licensor or the breach of this Agreement by Licensor.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
10.2. Procedure.
Licensor promptly shall notify Licensee of any liability or action
in respect of which Licensor intends to claim such indemnification,
and Licensee shall have the right to assume the defense thereof
with counsel selected by Licensee. The indemnity agreement in this
Section 10 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of
Licensee, which consent shall not be withheld unreasonably. The
failure to deliver notice to Licensee within a reasonable time
after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve Licensee of any
liability to Licensor under this Section 10, but the omission so to deliver notice to
Licensee will not relieve it of any liability that it may have to
Licensor otherwise than under this Section 10. Licensor under this Section 10, its employees and agents, shall cooperate
fully with Licensee and its legal representatives in the
investigation and defense of any action, claim or liability covered
by this indemnification.
10.3. Insurance.
During the term of this Agreement, Licensee shall maintain at its
own expense:
10.3.1. Comprehensive
general liability insurance for claims for damages arising from
bodily injury (including death) and property damages caused by, or
arising out of, acts or omissions of its employees, in such amounts
as are customary and reasonable in the Licensee’s
industry.
10.3.2. Product
liability insurance in such amounts as are customary and reasonable
in the Licensee’s industry.
10.3.3. Maintenance
of such insurance coverage shall not relieve Licensee of any
responsibility under this Agreement for damage in excess of the
insurance limits.
Neither
Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from Force Majeure events.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
12. GENERAL
PROVISIONS
12.1. Notices.
Any consent, notice or report required or permitted to be given or
made under this Agreement by one Party to the other Party shall be
in writing, delivered by any available means to such other Party at
its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and
shall be effective upon receipt by the addressee.
If to
Licensor:
Director
University Health
Network
Office
of Technology Development & Commercialization
MaRS
Centre, Heritage Building
000
Xxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx,
Xxxxxxx
Xxxxxx
X0X 0X0
If to
Licensee:
Chief Executive Officer
VistaGen
Therapeutics, Inc.
000
Xxxxxxxx Xxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
With
Copy to:
Xxxx
Xxxxx, Esq.
Law
Offices of Xxxx Xxxxx
0000
Xxxxxxx Xxxx
Xxxxx
000
Xxxxxxxx, XX
00000
12.2. Further
Representations, Warranties & Liability.
(a) Licensee
represents and warrants to Licensor that Licensee has the power to
enter into this Agreement and to perform its obligations, and that
Licensee has taken necessary action for the execution of this
Agreement to constitute a binding obligation enforceable against
Licensee.
(b) Licensor
represents and warrants to Licensee that Licensor has the power to
enter into this Agreement and to perform its obligations, and that
Licensor has taken necessary action for the execution of this
Agreement to constitute a binding obligation enforceable against
Licensor.
___________________
|
|
|
|
*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
|
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Exclusive License and Sublicense Agreement
(c) EXCEPT
AS EXPRESSLY PROVIDED IN THIS AGREEMENT, LICENSOR MAKES NO
CONDITIONS, WARRANTEES, UNDERTAKINGS OF ANY KIND, INCLUDING WITHOUT
LIMITATION, THE ORIGINALITY OR ACCURACY OR PATENTABILITY OR
VALIDITY OR NONINFRINGEMENT OF THE LICENSED PATENT(S), LICENSED IP,
OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE SUBJECT
MATTER OF, THIS AGREEMENT OR THE OWNERSHIP, MERCHANTABILITY, OR
FITNESS FOR A PARTICULAR PURPOSE OF THE LICENSED PATENT(S),
LICENSED IP, OR LICENSED PRODUCT(S) ARISING UNDER, OR OTHERWISE THE
SUBJECT MATTER OF THIS AGREEMENT.
(d) LICENSOR
SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, OR
OTHER DAMAGES SUFFERED BY LICENSEE (AND ITS AFFILIATE(S) AND
SUBLICENSEES) OR ANY OTHERS RESULTING FROM THE USE OF THE OF THE
LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S) ARISING
UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT. THE
ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, USE, EXPLOITATION,
MANUFACTURE, SALE OR OTHER DISPOSITION AND PERFORMANCE IN RESPECT
OF THE LICENSED PATENT(S), LICENSED IP, OR LICENSED PRODUCT(S)
ARISING UNDER, OR OTHERWISE THE SUBJECT MATTER OF THIS AGREEMENT IS
ASSUMED BY LICENSEE.
12.3. Dispute
Resolution.
(a) The
Parties agree to use reasonable best efforts to amicably resolve
among themselves any dispute arising out of this
Agreement.
(b) If
the Parties are unable to resolve the dispute under Section 8.5(a),
the dispute shall be referred to the Vice President, Research of
Licensor or the Vice President’s designate and the designate
of Licensee for their discussion and resolution. The Parties may
agree to mediation of the dispute (procedural details and process
to be determined by the Parties).
(c) Any
dispute which cannot be amicably settled by the Parties as provided
in Sections 8.5(a) and (b) shall be submitted to arbitration in
accordance with the provisions of the (Ontario) Arbitration Act,
1991, S.O. 1991, c.17, as amended from time to time. The
arbitration will take place in the city of Toronto (Ontario,
Canada).
(d) Notwithstanding
the foregoing, either Party shall have the right, without waiving
any right or remedy available to such Party under this Agreement or
otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending
the selection of the mediator(s) or arbitrator(s) hereunder, or
pending the mediator(s)’ or arbitrator(s)’
determination of any dispute, controversy or claim
hereunder.
12.4. Assignment.
Licensee shall not assign its rights or obligations under this
Agreement without the prior written consent of
Licensor;provided,
however, that
Licensee may, without such consent, assign this Agreement and its
rights and obligations hereunder (a) to any Affiliate, or
(b) in connection with the transfer or sale of all or
substantially all of its business to which this Agreement relates,
or in the event of its merger, consolidation, change in control or
similar transaction. Notwithstanding the aforementioned, Licensee
shall remain responsible for the performance of all obligations
under this Agreement (including, without limitation, the payment of
royalties to Licensor).
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
12.5. Waivers
and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions
herein contained, shall be valid unless made in writing and signed
by duly authorized representatives of the parties
hereto.
12.6. Entire
Agreement. This Agreement embodies the entire agreement
between the parties and supersedes any prior representations,
understandings and agreements between the parties regarding the
subject matter hereof. There are no representations, understandings
or agreements, oral or written, between the parties regarding the
subject matter hereof that are not fully expressed
herein.
12.7. Severability.
Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective
to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the
remaining provisions hereof and without affecting the validity or
enforceability of any of the terms of this Agreement in any other
jurisdiction.
12.8. Waiver.
The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other Party whether of a similar nature or
otherwise.
12.9. Counterparts.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument. Evidence of the execution
and delivery of this Agreement may be by a telecopy transmission to
a Party of the other Party’s signed copy of this
Agreement.
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
IN
WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date.
LICENSOR:
University of Health Network
By:
/s/ Xxxxxx X.
Xxxxxxx
Name:
Xxxxxx X. Xxxxxxx, PhD
Title:
Executive VP, Science & Research
LICENSEE:
VistaGen Therapeutics, Inc.
By:
/s/ Xxxxx X.
Xxxxx
Name:
Xxxxx X. Xxxxx, XX
Title:
Chief Executive Officer
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
A
DEFINITIONS
“Affiliate”
shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under
common control with, such Person. A Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other
ownership interest of the other Person, or if it directly or
indirectly possesses the power to direct or cause the direction of
the management and policies of the other Person by any means
whatsoever.
“Confidential
Information” shall mean, with respect to a Party, all
information (and all tangible and intangible embodiments thereof),
that is owned or controlled by such Party, is disclosed by or on
behalf of such Party to the other Party pursuant to this Agreement,
and (if disclosed in writing or other tangible medium) is marked or
identified as confidential at the time of disclosure to the
receiving Party or (if otherwise disclosed) is identified as
confidential at the time of disclosure to the receiving Party and
described as such in writing within thirty (30) days after such
disclosure. Notwithstanding the foregoing, Confidential Information
of a Party shall not include information which, and only to the
extent the receiving Party can establish by written documentation,
(a) has been generally known prior to disclosure of such
information by the disclosing Party to the receiving Party;
(b) has become generally known, without the fault of the
receiving Party, subsequent to disclosure of such information by
the disclosing Party to the receiving Party; (c) has been
received by the receiving Party at any time from a source other
than the disclosing Party, rightfully having possession of and the
right to disclose such information free of confidentiality
obligations; (d) has been otherwise known by the receiving
Party free of confidentiality obligations prior to disclosure of
such information by the disclosing Party to the receiving Party; or
(e) has been independently developed by employees or others on
behalf of the receiving Party without use of such information
disclosed by the disclosing Party to the receiving Party (each of
the aforementioned (a) to (e) a “Confidentiality
Exception”).
“Effective
Date” shall have the meaning set forth in the preamble
to this Agreement.
“FDA”
shall mean the Food and Drug Administration of the United States,
or the successor thereto, or
its foreign equivalent in Canada, the EU or elsewhere.
“Force
Majeure” means an event or circumstance arising
outside of the reasonable control of a party, such as any act of
God, flood, natural disaster, embargo, acts of civil or military
authorities, terrorism, labor strikes, governmental embargos, and
governmental orders.
“IND”
shall mean an investigational new drug application or similar
application which is required to be filed with the FDA prior to
commencing a clinical investigation of a drug pursuant to (US) 21
C.F.R. 312, or its foreign
equivalent in Canada, the EU or elsewhere.
“Intellectual
Property” or “IP” shall mean all
inventions (whether or not patentable), discoveries, trade secrets,
Confidential Information, Know-How, data, technology, formulae,
methods, processes, protocols, techniques, compositions, and other
protectable intangible rights, together with all related Patent
Rights, copyrights, trade secret rights, and other legally
enforceable rights.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
“Know-How”
shall mean all trade secrets, know-how, data, information,
compositions and other technology (including, but not limited to,
formulae, procedures, protocols, techniques and results of
experimentation and testing) which are necessary or useful to make,
use, develop, sell or seek regulatory approval to market a
composition, or to practice any method or process, at any time
claimed or disclosed in any issued patent or pending patent
application directly and specifically applicable to the Licensed
Patents, the Licensed IP, or the Licensed Products.
“Licensed
IP” shall have the meaning as defined in Exhibit
B.
“Licensed
Patents” shall mean the Patent Rights applicable to
the Licensed IP.
“Licensed
Product(s)” shall mean any product or service that if
made, used, provided, offered to be provided, sold, offered for
sale or imported would infringe (but for the License Agreement) a
Valid Claim of the Licensed Patents, or that otherwise uses or
incorporates the Licensed IP.
“Milestone
Event” shall have the meaning as defined in
Section 4.1.
“Milestone
Payment” shall have the meaning as defined in
Section 4.1.
“NDA”
shall mean a New Drug Application, or similar application for
marketing approval of a Product for use in the Field submitted to
the FDA, or its foreign
equivalent in Canada, the EU or elsewhere.
“Net
Sales” shall mean, with respect to any
Therapeutic-Related Licensed Product, the gross sales price of such
Therapeutic-Related Licensed Product invoiced by Licensee or its
Affiliates to customers who are not Affiliates (or are Affiliates
but are the end users of such Therapeutic-Related Licensed Product)
less, to the extent actually paid or accrued by License or its
Affiliate (as applicable), (a) reasonable credits, allowances,
discounts and rebates to, and chargebacks from the account of, such
customers for nonconforming, damaged, out-dated and returned
Therapeutic-Related Licensed Product; (b) freight and
insurance costs incurred by License or its Affiliate (as
applicable) in transporting such Therapeutic-Related Licensed
Product to such customers; (c) reasonable cash, quantity and
trade discounts, rebates and other price reductions for such
Therapeutic-Related Licensed Product given to such customers under
price reduction programs; (d) sales, use, value-added and
other direct taxes incurred on the sale of such Therapeutic-Related
Licensed Product to such customers; (e) customs duties,
tariffs, surcharges and other governmental charges incurred in
exporting or importing such Therapeutic-Related Licensed Product to
such customers; and (f) a reasonable allowance for uncollectible or
bad debts determined in accordance with generally accepted
accounting principles.
“Party”
shall mean either VistaGen or UHN; and “Parties” shall mean both
VistaGen and UHN.
“Patent
Rights” shall mean (a) all patents and patent
applications worldwide describing the Licensed IP listed on Exhibit
B hereto, (b) all divisions, continuations,
continuations-in-part, that claim priority to, or common priority
with, the patent applications listed in clause (a) above or the
patent applications that resulted in the patents described in
clause (a) above, and (c) all patents that have issued or in
the future issue from any of the foregoing patent applications,
including utility, model and design patents and certificates of
invention, together with any reissues, renewals, extensions or
additions thereto worldwide.
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
“Person”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
“Phase I
Clinical Trial” shall mean a human clinical trial that
is intended to initially evaluate the safety and/or pharmacological
effect of a Product in subjects or that would otherwise satisfy
requirements of (US) 21 C.F.R. 312.21(a), or its foreign equivalent in Canada, the
EU or elsewhere.
“Phase II
Clinical Trial” shall mean a human clinical trial in
any country that is intended to initially evaluate the
effectiveness of a Product for a particular indication or
indications in patients with the disease or indication under study
or would otherwise satisfy requirements of (US)
21 C.F.R. 312.21(b), or its foreign equivalent in Canada, the
EU or elsewhere.
“Phase III
Clinical Trial” shall mean a human clinical trial in
any country, the results of which could be used to establish safety
and efficacy of a Product as a basis for an NDA or would otherwise
satisfy requirements of (US) 21 C.F.R. 312.21(c),
or its foreign equivalent in
Canada, the EU or elsewhere.
“Revenues”
shall mean (i) Net Sales on a country-by-country basis of
Therapeutic-Related Licensed Product(s) sold by Licensee and its
Affiliates on a country-by-country basis, (ii) Sublicensing
Consideration received by Licensee and its Affiliates from
Sublicense Agreements, and (iii) Service Sales on a
country-by-country basis in respect of Service-Related Licensed
Product(s).
“Service-Related
Licensed Product” shall mean a Licensed Product (i)
that is used in and/or for the provision of a research, development
or other service to a third party, or (ii) for use in, or as part
of, a diagnostic kit or service.
“Service
Sales” shall mean, with respect to any Service-Related
Licensed Product, the gross amount of monies received for,
associated with, or in respect of Service-Related Licensed
Product(s) invoiced by Licensee or its Affiliates to customers or
otherwise to third parties who are not Affiliates (or are
Affiliates but are the end users, beneficiaries, or otherwise
recipients of such Service-Related Licensed Product(s)) less, to
the extent actually paid or accrued by License or its Affiliate (as
applicable), (a) reasonable credits, allowances, discounts and
rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Service-Related
Licensed Product; (b) freight and insurance costs incurred by
License or its Affiliate (as applicable) in transporting such
Service-Related Licensed Product to such customers;
(c) reasonable cash, quantity and trade discounts, rebates and
other price reductions for such Service-Related Licensed Product
given to such customers under price reduction programs;
(d) sales, use, value-added and other direct taxes incurred on
the sale of such Service-Related Licensed Product to such
customers; (e) customs duties, tariffs, surcharges and other
governmental charges incurred in exporting or importing such
Service-Related Licensed Product to such customers; and (f) a
reasonable allowance for uncollectible or bad debts determined in
accordance with generally accepted accounting
principles.
“Sublicense
Agreement” shall mean any agreement or commitment
pursuant to which any of the rights of Licensee under this
Agreement are sublicensed or otherwise extended, granted or given
to a Third Party (a Sublicensee).
___________________
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*****
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VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
“Sublicensee”
shall mean any Third Party to whom Licensee (or its Affiliates)
grants rights to use some of Licensee’s rights under this
Agreement.
“Sublicensing
Consideration” shall mean the aggregate consideration
received by Licensee or its Affiliates in consideration for
granting sublicense rights to a Sublicensee under the Licensed IP,
including without limitation license fees, milestone fees, minimum
royalties, and earned royalties, but excluding (a) amounts
received to fund or reimburse Licensee’s or its
Affiliates’ cost to perform research, development or similar
services specifically and directly associated with Licensed
Products, (b) amounts received in reimbursement of Licensed IP
patent or other Licensed IP-related out-of-pocket expenses
specifically and directly associated with Licensed Products; and
(c) amounts received in consideration for the sale of any debt
or securities of Licensee or its Affiliates.
“Therapeutic-Related
Licensed Product” shall mean a Licensed Product that
forms a constituent part of a therapeutic agent for use in human
medical or veterinary purposes.
“Third
Party” shall mean any Person other than Licensor,
Licensee and their respective Affiliates.
“Valid
Claim” shall mean a claim of an issued and unexpired
patent included within the Licensed Patent, which has not been held
permanently revoked, unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
___________________
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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Exclusive License and Sublicense Agreement
EXHIBIT
B
LICENSED IP
[*****].
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*****
|
VISTAGEN THERAPEUTICS, INC. HAS REQUESTED THAT THE OMITTED PORTIONS
OF THIS DOCUMENT, WHICH ARE INDICATED BY [*****], BE AFFORDED
CONFIDENTIAL TREATMENT. VISTAGEN THERAPEUTICS, INC. HAS SEPARATELY
FILED THE OMITTED PORTIONS OF THE DOCUMENT WITH THE SECURITIES AND
EXCHANGE COMMISSION.
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