EXCLUSIVE LICENSE AND SUBLICENSE AGREEMENT by and between VISTAGEN THERAPEUTICS, INC. and APOLLO BIOLOGICS LP
Execution Version
Exhibit
10.1
EXCLUSIVE LICENSE
AND SUBLICENSE AGREEMENT
by and
between
and
APOLLO
BIOLOGICS LP
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, [*****] (“License Agreement Number
One”), (ii) License Agreement, [*****]
(“License Agreement
Number Two”), (iii) License Agreement, [*****]
(“License Agreement
Number Three”) and (iv) License Agreement,
[*****] (“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:
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.
___________________
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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
1.4 “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.
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 [*****].
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.
___________________
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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
1.17 “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.
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
(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. [*****].
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.
___________________
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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
(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.
2.2 Sublicenses. 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.
___________________
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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
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.
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.
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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
(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.
(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 [*****] basis as
to each Revenue Bearing Product, until the expiration or
termination of the last to expire Valid Claim within [*****] 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 [*****] in
development milestone payments under this
Section 4.1(g).
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Development
Milestone Event
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Milestone
Payment
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(A)
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[*****]
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[*****]
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(B)
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[*****]
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[*****]
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(C)
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[*****]
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[*****]
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(D)
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[*****]
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[*****]
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(i) [*****]
(ii) [*****]
(iii) [*****].
___________________
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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
(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 [*****]
in commercial milestone payments under this
Section 4.1(i).
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Commercial
Milestone Event
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Milestone Payment
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(A)
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[*****]
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[*****]
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(B)
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[*****]
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[*****]
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(C)
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[*****]
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[*****]
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(D)
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[*****]
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[*****]
|
(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.
(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.
___________________
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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
(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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*****
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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.
|
-9-
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.
___________________
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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.
|
-10-
Exclusive License and Sublicense Agreement
(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.
___________________
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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.
|
-11-
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.
ARTICLE
7
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.
___________________
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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
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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*****
|
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
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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|
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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
9.2 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.
___________________
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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 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.
(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.
___________________
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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
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.
(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.
___________________
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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
(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.
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.
___________________
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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
14.3 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.
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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Exclusive License and Sublicense Agreement
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APOLLO BIOLOGICS
LP
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By: BJD Newco, LLC, its general
partner
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By: /s/ Xxxxx
Xxxxx
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Name: Xxxxx
Xxxxx
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Title: Authorized
Representative
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Exclusive License and Sublicense Agreement
EXHIBIT
A
LICENSED
IP
[*****]
[*****]
A-1
Exclusive License and Sublicense Agreement
[*****]
[*****]
A-2
Exclusive License and Sublicense Agreement
[*****]
A-3
Exclusive License and Sublicense Agreement
[*****]
A-4
Exclusive License and Sublicense Agreement
[*****]
A-5
Exclusive License and Sublicense Agreement
[*****]
A-6
