OPTION AGREEMENT
Exhibit
10.2
This
Option Agreement (“Agreement”), effective on September
11, 2018 (the “Effective Date”), is by and between
Pherin Pharmaceuticals, Inc., a California corporation with offices
at 0000 Xxxxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000
(“SELLER”), and VistaGen Therapeutics, Inc., a Nevada
corporation with offices at 000 Xxxxxxxx Xxxxxx, Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000 (“BUYER”). BUYER and SELLER
are sometimes referred to separately as a “Party” and
collectively as the “Parties.
RECITALS
WHEREAS, SELLER desires to sell and BUYER desires
to buy an exclusive option to license exclusively all of
SELLER’s assets, interests,
property and rights (the “Option Assets”) related to
SELLER’s intranasal synthetic neuroactive steroid product for
the treatment of major depressive disorder as set forth in
Attachment
A to this Agreement
(hereinafter, the “Option”).
WHEREAS,
SELLER and BUYER desire to enter into this Agreement to set forth
the Option terms.
NOW
THEREFORE, in consideration of the mutual covenants and agreements
set forth herein and for other good and valuable consideration the
receipt and adequacy of which is hereby acknowledged, the parties
hereto, intending to be legally bound, hereby agree as
follows:
AGREEMENT
1. The
Option. Upon the terms and
subject to the conditions set forth herein, SELLER hereby sells and
BUYER hereby purchases the Option for an aggregate sum of
two hundred fifty thousand dollars ($250,000), which amount shall
be payable solely in unregistered shares of common stock of BUYER.
For avoidance of doubt, the Parties agree that the number of shares
of BUYER common stock to be issued to SELLER shall be determined by
dividing the closing price of BUYER’s common stock on the
Nasdaq Capital Market on the trading day immediately prior to the
Effective Date into two hundred fifty thousand dollars ($250,000)
(the “Purchase
Price” for the Option).
The Parties agree that the exclusive license to be entered into
pursuant to the Option is set forth in Attachment B
to this Agreement (the “Patent
License”). The Purchase Price shall be delivered to
SELLER as soon as practicable after the Effective Date, but
no later than ten (10) business days after the Effective
Date.
2. Term.
The Option shall expire twenty-four (24) months after the Effective
Date if not exercised by BUYER prior to that date pursuant to
Section 4 below (the “Option
Period”); provided,
however, that if a US patent has not been granted within that time
period, the Option Period may be extended for an additional twelve
(12) months at the sole discretion of the BUYER by providing
written notice of such extension to the SELLER no later than thirty
(30) days prior to the expiration date of the initial Option Period
and the payment of an additional sum of one hundred dollars
($100.00) (the “Extension Fee”). The Extension Fee
shall be
___________________
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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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delivered to SELLER by a wire transfer of
immediately available funds on the date BUYER delivers notice of
such Option extension to SELLER. BUYER shall have the right to
terminate this Agreement at any time in its sole discretion without
exercising the Option.
3. Exclusivity.
During the Option Period, including any extension thereof, BUYER
shall have the exclusive right to the Option. SELLER shall not
sell, license, mortgage or encumber in any way any rights that
would limit BUYER’s rights hereunder to the complete exercise
of the Option during the Option Period, including any extension
thereof.
4. Exercise.
BUYER must give SELLER written notice of its intent to exercise the
Option within the Option Period, including any extension thereof
(the “Exercise
Notice”). The Exercise
Notice shall be deemed effectively given on the earlier of (a) the
date received by SELLER, (b) the date personally delivered to
SELLER by BUYER, (c) the date that is one day after the date
delivered to SELLER by BUYER by facsimile (with receipt of
confirmation), (d) the date that is one day after being delivered
to SELLER by overnight courier service, and (e) the date that is
four (4) days after being deposited in United States mail, First
Class, with postage prepaid and return receipt requested. The
Parties shall be deemed to have agreed to, and will become bound
by, the Patent License on the date the Exercise Notice is
effectively given.
5. Representations.
(a) SELLER
represents that Attachment A sets forth a true, correct and complete
description of the SELLER’s assets, interests, property and
rights covered by the Option (the “Option Assets”).
SELLER has good and valid title in such assets, interests, property
and rights, and they are not subject to any lien, mortgage or
encumbrance that would prevent the exercise of the Option and the
signing and enforceability of the Patent License. SELLER is not
aware of any actual, threatened or potential challenge by anyone
that might affect SELLER’s representations in this Article 5.
SELLER will use its best efforts to preserve and protect the Option
Assets in contemplation of their transfer to BUYER upon its
exercise of the Option.
(b) SELLER
represents that there are no agreements between any third party and
SELLER preventing the exercise of the Option by BUYER in the manner
contemplated by this Agreement.
(c) SELLER
and BUYER represent that they have all requisite corporate power
and corporate authority to execute and deliver this Agreement and
to perform its obligations hereunder. The execution and delivery by
each Party of this Agreement and the consummation of the
transactions contemplated hereby have been duly and validly
authorized by all necessary corporate actions.
(d) SELLER
and BUYER make no other representations or warranties in connection
with this Agreement other than as specified above.
___________________
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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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6. Miscellaneous
(a)
Governing
Law. This Agreement and any
dispute arising from the performance or breach hereof shall be
governed by and construed and enforced in accordance with the laws
of the State of California as applied to disputes involving parties
located entirely within the State and also without reference to the
State’s conflicts of laws principles.
(b)
Waiver.
Neither Party may waive or release any of its rights or interests
in this Agreement except in writing. The failure of either Party to
assert a right hereunder or to insist upon compliance with any term
or condition of this Agreement shall not constitute a waiver of
that right or excuse a similar subsequent failure to perform any
such term or condition.
(c)
Assignability.
Neither Party may assign its rights under this Agreement without
the prior written consent of the other Party, such consent not to
be unreasonably withheld. Notwithstanding the foregoing, BUYER may
assign its rights under this Agreement to a successor in connection
with a merger, consolidation, spin-off or sale of all or
substantially all of its assets or that portion of its business
pertaining to subject matter of this Agreement, without prior
written consent of SELLER.
(d)
Notices.
All notices, requests and other communications hereunder shall be
in writing and shall be personally delivered or sent by courier or
by registered or certified mail, return receipt requested, postage
prepaid, in each case to the respective address specified below, or
such other address as may be specified in writing to the other
Parties hereto:
BUYER:
VistaGen Therapeutics, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
Phone:
000-000-0000
Fax:
000-000-0000
ATTN:
Xxxxx Xxxxx, Chief Executive Officer
with
a required copy to:
Xxxx
Xxxxx, Esq.
Law
Office of Reid G. Xxxxx, XX
0000
Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxx,
XX 00000
Phone:
(000)-000-0000
Fax:
(000)-000-0000
SELLER:
Pherin Pharmaceuticals, Inc.
0000
Xxxxxxx Xxxxxx
Xxxxxxxx
Xxxx, XX 00000
Phone:
(000)-000-0000
___________________
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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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ATTN:
Xx. Xxxxx Xxxxx, Executive Vice President
with
a required copy to:
Xxx
X. Xxxxxx, Esq.
Xxxxxxxx,
XxXxxxxxx & Cha, LLP
0000
Xx Xxxxxx Xxxx, Xxxxx 000
Xxxx
Xxxx, XX 00000
Phone:
(000)-000-0000
(e)
Force
Majeure. Neither Party shall be
liable to the other for failure or delay in the performance of any
of its obligations under this Agreement for the time and to the
extent such failure or delay is caused by riots, civil commotions,
wars, hostilities between nations, embargoes, actions by a
government or any agency thereof, acts of God, storms, fires,
accidents, sabotage, explosions or other similar or different
contingencies, the damage or harm resulting from any or all of
which, in each case, shall be beyond the reasonable control of the
Party invoking this Section 5(e) and not attributable to the
negligence or willful misconduct of the Party invoking this Section
5(e). The Party affected by force majeure shall provide the other
Party with full particulars thereof as soon as it becomes aware of
the same (including its best estimate of the likely extent and
duration of the interference with its activities), and will use
reasonable efforts to overcome the difficulties created thereby and
to resume performance of its obligations as soon as practicable. If
the performance of any obligation under this Agreement is delayed
owing to a force majeure event for any continuous period of more
than six (6) months, the Parties hereto shall consult with respect
to an equitable solution, including the possible termination of
this Agreement.
(f)
Disclosure
of the Agreement and Use of
Name. The Parties may disclose the existence and general
nature of this Agreement. BUYER also may disclose the Agreement to
potential investors and strategic partners to facilitate
development and commercialization of the Option Assets. BUYER may
use the name of SELLER for promotional and regulatory compliance
purposes, as necessary and appropriate.
(g)
Severability.
If any provision of this Agreement becomes or is declared by a
court of competent jurisdiction to be illegal, unenforceable or
void, this Agreement shall continue in full force and effect
without said provision, so long as the Agreement, taking into
account said voided provision(s), continues to provide the Parties
with the same practical economic benefits as the Agreement
containing said voided provision(s) did on the date of this
Agreement. If, after taking into account said voided provision(s),
the Parties are unable to realize the practical economic benefit
contemplated on the date of this Agreement, the Parties shall
negotiate in good faith to amend this Agreement to reestablish the
practical economic benefit provided the Parties on the date of this
Agreement.
(h)
Complete
Agreement. This Agreement,
including Attachments A and B hereto, shall constitute the entire
agreement, both written and oral, between the Parties
with
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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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respect to the subject matter hereof, and all
prior agreements respecting the subject matter hereof, either
written or oral, expressed or implied, are merged and canceled, and
are null and void and of no effect. No amendment or change hereof
or addition hereto shall be effective or binding on either of the
Parties hereto unless reduced to writing and duly executed on
behalf of both Parties.
(i)
Headings.
The captions to the sections and articles in this Agreement are not
a part of this Agreement but are included merely for convenience of
reference only and shall not affect its meaning or
interpretation.
(j)
Counterparts and
Signatures. This Agreement may
be executed in counterparts, or facsimile versions, each of which
shall be deemed to be an original, and both of which together shall
be deemed to be one and the same agreement. Signatures to this
Agreement transmitted by facsimile transmission, by electronic mail
in “portable document format” (“.pdf”)
form, or by any other electronic means intended to preserve the
original graphic and pictorial appearance of a document, will have
the same effect as physical delivery of the paper document bearing
the original signature.
(k)
Binding
Effect. This Agreement and the
option granted herein shall be binding upon and shall inure to the
benefit of SELLER, BUYER and their successors and permitted
assigns.
(l)
Advice of
Counsel and Expenses. BUYER and
SELLER have each consulted with counsel of their choice regarding
this Agreement, and each acknowledges and agrees that this
Agreement shall not be deemed to have been drafted by one party or
another and will be construed accordingly. Except as otherwise
expressly provided in this Agreement, each Party shall pay the fees
and expenses of its respective attorneys and all other expenses and
costs incurred by such Party incidental to the negotiation,
preparation, execution and delivery of this
Agreement.
(m)
Intellectual Property
Matters. During the Option
Period, including any extension thereof, BUYER shall use diligent
efforts to prosecute and maintain the patents and patent
applications listed in Attachment A (the “Option
Patents”), including requesting examination of the
applications in Canada and South Korea, at BUYER’s expense.
BUYER agrees to keep SELLER fully advised of the status of all
Option Patents; and will provide SELLER with a reasonable
opportunity to comment on the prosecution and maintenance of the
Option Patents. SELLER agrees to cooperate with BUYER in such
patent-related activities at BUYER’s reasonable request and
expense. BUYER realizes that US Application No. 14/134906 is
presently on appeal to the Patent Trial and Appeal Board, and that
applications in Canada, Korea, and Mexico are as yet
unexamined.
(n)
Option
Assets. Within thirty (30) days
after the Effective Date of this Agreement, SELLER will provide
BUYER with a complete list of the Option
Assets.
(o)
Further
Assurance. Each Party shall
perform all further acts and execute and deliver such further
documents as may be necessary or as the other Party may
reasonably
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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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require to give effect to this Agreement. SELLER
agrees that doing so may require from time-to-time the good faith
disclosure to or discussion with BUYER of selected Option Assets.
The Parties further agree to sign and date the Patent License upon
BUYER’s exercise of the Option and to make amendments to the
Patent License in good faith as reasonably may be necessary to give
effect to the Parties’ intentions that BUYER will have a
valid and binding exclusive license to the Option
Assets.
IN WITNESS WHEREOF,
the undersigned have caused this
Agreement to be duly executed and delivered by their proper and
duly authorized officers as of the date and year first written
above.
BUYER:
VistaGen Therapeutics, Inc.,
a
Nevada corporation
By: /s/ Xxxxx
Xxxxx
Name:
Xxxxx Xxxxx
Title: Chief Executive Officer
SELLER:
Pherin Pharmaceuticals, Inc.,
a
California corporation
By: /s/ Xxxxx
Xxxxx
Name:
Xxxxx Xxxxx, MD, PhD
Title:
Executive Vice President
___________________
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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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Attachment A
THE OPTION ASSETS
The Parties agree that the Option includes and covers all of
SELLER’s assets,
interests, property and rights in any pharmaceutical
formulation containing as an active ingredient
pregn-4-en-20-yn-3-one, an intranasal formulation of which is
presently an investigational drug candidate of SELLER for the
treatment of major depressive disorder and is referred to by SELLER
as PH10. For the avoidance of doubt, the Option includes
all relevant program assets including
all US and foreign patent properties and all other intellectual
property rights such as know-how and trade secrets and all stocks
of chemical compounds, data, research records, reports from
external contract research organizations on manufacturing,
formulation, toxicology, pharmacology and other aspects pertinent
to the development of PH10, including Phase 1 and 2 clinical and
safety data, regulatory analyses and
submissions and the like that are Controlled by SELLER as of the
Effective Date of this Agreement or are developed or produced
during the term of this Agreement. The Parties intend that BUYER
will be able to commercialize the PH10 candidate compound and its
associated program with all of the assets, resources and rights
that would otherwise remain available to SELLER in the absence of
the Option.
For purposes of this Agreement, “Controlled” means in
the context of intellectual property rights and other property
rights or interests of a Party, that such Party owns or possesses
rights sufficient to effect the transfers or grant the applicable
license under this Agreement, without violating the terms of any
agreement with a third party.
For purposes of this Agreement, “Know-How” means any
know-how, technical information and data that is necessary or has
been or reasonably would be used for the commercialization,
development, manufacture, use and sale of the PH10 candidate
compound, including, without limitation, any reports or disclosures
concerning research or inventions provided or disclosed to, or
otherwise received by, BUYER from SELLER.
___________________
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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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[*****]
___________________
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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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Attachment B
LICENSE AGREEMENT
This
License Agreement (“Agreement”), effective on
,
20 , is by and
between Pherin Pharmaceuticals, Inc., a California corporation with
offices at 0000 Xxxxxxx Xxxxxx, Xxxxxxxx Xxxx, XX 00000
(“LICENSOR”), and VistaGen Therapeutics, Inc., a Nevada
corporation with offices at 000 Xxxxxxxx Xxxxxx, Xxxxx Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000 (“LICENSEE”).
WHEREAS, LICENSOR
has developed an intranasal synthetic neuroactive steroid product
for the treatment of depression, referred to by LICENSOR as PH10;
and
WHEREAS, LICENSEE
wishes to license rights to that product from LICENSOR on an
exclusive worldwide basis; and
WHEREAS, LICENSOR
and LICENSEE (each separately as a “Party” and
collectively as the “Parties”) desire to enter into
this Agreement to set forth the licensing terms for that
product.
NOW
THEREFORE, intending to be legally bound, the Parties agree as
follows:
Article
1.
DEFINITIONS
1.1
"Affiliate(s)" means all corporations or business entities which,
directly or indirectly, are controlled by, control, or are under
common control with a person. For this purpose, the meaning of the
word "control" means the ownership, control or holding, direct or
indirect of fifty percent (50%) or more of the securities or other
ownership interests representing the equity, voting stock,
preferred stock, general partnership, limited partnership or
limited liability company interest of such entity.
1.2
“Commercialize” or “Commercialization”
means any and all activities directed to the Development (as
defined below) and commercialization of Licensed Product, including
pre‐launch
and post‐launch marketing,
promoting, distribution, retailing or selling of Licensed Product
(as well as importing and exporting activities in connection
therewith). When used as a verb, “Commercialize” means
to engage in Commercialization.
1.3
“Control” or “Controlled” means the legal
authority or right (whether by ownership, license or otherwise) to:
(i) with respect to any molecule or material, grant ownership of or
a license or sublicense to use such molecule or material; (ii) with
respect to any know‐how, patents, other
intellectual property, grant ownership of or a license or a
sublicense under such know‐how, patents, or
intellectual property; or (iii) with respect to any proprietary or
trade secret information, disclose such information; in each case
without breaching the terms of any
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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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agreement with,
obligation to or other arrangement with a third-party, or
misappropriating the proprietary or trade secret information of a
third-party.
1.4
“Confidential Information” means, subject to the
exclusions of Section 5.1, all information that has or could have
commercial value or other utility in a Party’s business, or
the unauthorized disclosure of which could be detrimental to the
Party’s interests, including confidential information,
inventions, know-how, data and materials relating to Licensed
Product, and shall include without limitation research, technical,
development, manufacturing, marketing, financial, personnel and
other business information and plans, whether in oral, written,
graphic or electronic form.
1.5
“Develop” or “Development” means any and
all research and development activities for Licensed Product
conducted anywhere in the Territory on and after Effective Date
relating to Licensed Product, including all nonclinical,
preclinical and clinical activities, testing and studies of
Licensed Product, manufacturing development, process development,
toxicology studies, distribution of Licensed Product for use in
clinical trials (including placebos and comparators), research and
development of companion diagnostics for use in connection with
clinical trials of Licensed Product as well as approved Licensed
Product, statistical analyses, and the preparation, filing and
prosecution of any NDA and obtaining or maintaining Regulatory
Approvals for Licensed Product, as well as all regulatory affairs
related to any of the foregoing. When used as a verb,
“Develop” means to engage in Development.
1.6
“Effective Date” means the effective date of this
Agreement as set forth in its first paragraph.
1.7
“First Commercial Sale” means the first sale of
Licensed Product in the Territory by LICENSEE, its Affiliates or
sublicensee, or a third-party distributor or wholesaler under
contract with LICENSEE, its Affiliates or
sublicensees.
1.8
“Field” means the treatment, prevention and diagnosis
of human and veterinary diseases and conditions, including, but not
limited to, depression.
1.9
“Improvements” means any inventions or discoveries that
relate to Licensed Product, its manufacture, properties and
applications and that fall within the scope of the Licensed Patents
and Licensed Know-How.
1.10
“Licensed Know‐How” means any
and all unpatented and/or non-patentable technical data, documents,
materials, samples and other information and know‐how that is Controlled
by LICENSOR or any of its Affiliates as of the Effective Date or
thereafter during the Term that relates to, or is otherwise
reasonably necessary or reasonably useful for, the use,
Development, manufacture, or Commercialization of the Product.
Licensed Know-How shall not include 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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1.11
“Licensed IP” means the Licensed Patents and Licensed
Know‐How
and any Improvements controlled by LICENSOR.
1.12
“Licensed Patents” means any and all patents and patent
applications that are Controlled by LICENSOR or any of its
Affiliates as of the Effective Date or thereafter during the Term
that: (a) are set forth in Schedule 1 to this Agreement;
and/or (b) claim the composition of matter of, or the method of
manufacturing, or using, Licensed Product; or (c) that otherwise
relate to, or are reasonably necessary or reasonably useful for,
the use, Development, manufacture or Commercialization of Licensed
Product, including any related provisionals, divisionals,
continuations, continuations-in-part, reissues and extensions, as
well as all foreign patents and foreign patent counterparts, such
as supplementary protection certificates, to the
foregoing.
1.13
“Licensed
Product” means any pharmaceutical formulation for intranasal
administration containing as an active ingredient
pregn-4-en-20-yn-3-one.
1.14
“NDA” means a New Drug Application for regulatory
approval to market and sell Licensed Product for the acute
treatment of depression that is filed with the U.S. Food and Drug
Administration (“FDA”) or the European Medicines Agency
(“EMEA”).
1.15
“NDA
Approval” means an NDA approved by the FDA or EMEA that is
not conditioned on any other event (or if NDA Approval is
conditioned upon an event, then the occurrence of that event),
provided, however, such other events shall specifically not include
FDA or EMEA requirements to conduct post marketing studies and any
requirement for such post marketing studies shall not be deemed to
delay the Final Approval.
1.16
“Net Sales” means the gross amount collected by
LICENSEE and its Affiliates and sublicensees for arm’s length
sales or other transfers of the Licensed Product in countries in
the Territory in which there is a Licensed Patent set forth in
Schedule 1, to an end user or distributor of the Licensed Product,
less the following:
(a)
customary trade,
quantity, or cash discounts to the extent actually allowed and
taken;
(b)
amounts repaid or
credited by reason of rejection or return; and
(c)
to the extent
separately stated on purchase orders, invoices, or other documents
of sale, any taxes or other governmental charges levied on the
production, sale, transportation, delivery or use of the Licensed
Product which is paid by or on behalf of LICENSEE; and outbound
transportation costs prepaid or allowed and costs of insurance in
transit.
For the
avoidance of doubt, transfers of Licensed Product between any of
LICENSEE, its Affiliates or sublicensees for sale by the transferee
shall not be considered Net Sales.
___________________
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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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Net
Sales and LICENSEE’s obligation to pay royalties will be
determined on a country‐by‐country basis starting with
the first Commercial sale of such Licensed Product in such country
and terminating upon the later to occur of either: (a) the
expiration or other lapse in protection by the last Valid Patent
Claim covering the approved Licensed Product in such country (the
“End of Patent Protection”); or (b) the expiration or
other lapse in protection of regulatory exclusivity covering the
approved Licensed Product in such country (the “End of
Regulatory Protection”) if granted and extending beyond the
End of Patent Protection. Notwithstanding the status of patent or
regulatory protection, Net Sales and LICENSEE’s obligation to
pay royalties shall be considered as terminated upon the
availability in such country of an approved generic version of the
Licensed Product from an unlicensed third-party.
1.17
“Territory” means all countries worldwide.
1.18
“Valid Patent Claim” means a claim of the Licensed
Patents that has not lapsed or become abandoned or been declared
invalid or unenforceable by a court or agency of competent
jurisdiction from which no appeal can be or is taken.
Article
2.
GRANT OF LICENSE AND ACCESS
2.1
Exclusive License.
LICENSOR grants LICENSEE a worldwide, exclusive license, even as to
LICENSOR, with the right to sublicense, under the Licensed IP to
Develop, Commercialize, make, have made, import, use, offer to
sell, sell and have sold Licensed Product in the Field and in the
Territory. Except for permitted Collaboration Activities, LICENSOR
will not Develop or Commercialize in the Territory (i) any Licensed
Product, or (ii) any product for the treatment of
depression.
2.2
Rights to
Improvements. During the term of this Agreement, LICENSOR
agrees to advise LICENSEE in writing on at least a semi-annual
basis of any Improvements made by LICENSOR. Such LICENSOR
Improvements shall become Licensed IP and be subject to the license
right granted in Section 2.1; however, no additional royalty fees
or other consideration shall be due for the use of such
Improvements by LICENSEE. During the term of this Agreement,
LICENSEE agrees to advise LICENSOR in writing on at least a
semi-annual basis of any Improvements made by
LICENSEE.
2.3
Right to
Sublicense. LICENSEE will have the right to grant
sublicenses under the license granted in Section 2.1 of this
Agreement, through multiple tiers, to any Affiliate or third-party.
Each sublicense of LICENSEE’s rights shall be in writing,
shall be consistent with the terms and conditions hereof, and shall
require the sublicensee, in granting any further sublicenses, to
comply with LICENSEE’s sublicensing obligations hereunder as
though such sublicensee were LICENSEE. If LICENSEE grants a
sublicense to any third-party, then LICENSEE shall: (i) include in
each such sublicense agreement terms that permit LICENSEE to comply
with its obligations under this Agreement between LICENSOR and
LICENSEE, including related to reporting sales of Licensed Product
to LICENSOR; (ii) notify LICENSOR of such sublicense or amendment
thereto within thirty (30) days after it becomes effective,
including the identity of the sublicensee and the territory in
which such rights have been
___________________
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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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sublicensed; (iii)
at LICENSOR’s request, provide LICENSOR a copy of such
sublicense agreement and amendment thereto (provided that LICENSEE
may redact those provisions of such agreement or amendment that are
unrelated to LICENSEE’s obligations under this Agreement);
and (iv) use commercially reasonable efforts to enforce the terms
of such sublicense agreement that relate to LICENSEE’s
obligations under this Agreement.
2.4
Supply and
Manufacturing. The Parties acknowledge and agree that, as of
the Effective Date, LICENSOR is not subject to any obligations with
a third- party regarding its current source of Licensed Product,
and that LICENSEE shall be permitted to enter into a supply
agreement with any third-party manufacturer to secure supply of
Licensed Product for LICENSEE directly from such third-party
manufacturer. In addition, LICENSOR acknowledges that, upon
execution and delivery of the Agreement, LICENSEE shall receive all
right, title and interest in LICENSOR’s existing inventory of
Licensed Product, whether or not vialed, and all other materials
related to the manufacture, formulation and vialing of Licensed
Product.
2.5
Regulatory Matters; Right
of Reference. LICENSEE shall control all regulatory
interactions and decisions relating to the Licensed Product in the
Territory and shall hold the NDA and other regulatory approvals for
the Licensed Product in the Territory. LICENSEE shall have the
exclusive right to reference and use all information,
know‐how,
and data generated in LICENSOR’s prior and future depression
clinical trials and other development activities related to
Licensed Product conducted by LICENSOR prior to and following the
Effective Date of the Agreement in support of regulatory filings
and regulatory approvals for the Licensed Product in the
Territory.
2.6
Access to LICENSOR
Employees. In order to permit the transfer of Licensed
Know-How and otherwise to facilitate the development and
commercialization of Licensed Product, LICENSOR agrees to permit
LICENSEE reasonable access to those LICENSOR employees named as
inventors of the Licensed Patents and other employees of LICENSOR
who possess Licensed Know-How.
2.7
Joint Steering
Committee. Upon the Effective Date, the Parties will
establish a Joint Steering Committee (JSC) to provide strategic
leadership for the development of Licensed Product. Xx. Xxxxx Xxxxx
will be LICENSOR’s sole representative on the JSC. LICENSEE
will share with LICENSOR, through Xx. Xxxxx, copies of regulatory
filings and study reports relating to Licensed Product as soon as
practicable after they are made available to LICENSEE. For the
avoidance of doubt, as between the Parties, LICENSEE will have the
sole discretion and final decision-making authority on all matters
considered by the JSC relating to the Development of Licensed
Product.
Article
3.
LICENSE FEE, ROYALTIES AND OTHER PAYMENTS
3.1
License
Fee. In consideration of the
grant of rights in Article 2 of this Agreement, as soon as
practicable after the Effective Date, but no later than ten (10)
business days after the Effective Date, LICENSEE will pay LICENSOR
a one-time license fee of [*****],
___________________
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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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which amount shall be payable solely in unregistered shares of
common stock of LICENSEE. For avoidance of doubt, the Parties agree
that the number of shares of LICENSEE common stock to be issued to
LICENSOR shall be determined dividing the closing price of
LICENSEE’s common stock on the Nasdaq Capital Market on the
trading day immediately prior to the Effective Date into
[*****].
3.2
Royalty on Licensed
Product. In consideration of the grant of rights under
Article 2 of this Agreement, LICENSEE will pay LICENSOR a royalty
as a percentage of Net Sales generated by Licensee and/or its
Affiliates in the Territory from the Commercial sale of Licensed
Product in each calendar year during the Term until the End of
Patent Protection, as follows:
●
[*****];
●
[*****];
and
●
[*****].
Notwithstanding
the foregoing royalty rates, LICENSEE will pay LICENSOR a reduced
royalty that is [*****] of the stated rates for Net Sales in any
country that are made after the End of Patent Protection but before
the End of Regulatory Protection. In the event that LICENSEE or an
Affiliate sublicenses its rights under this Agreement to a
third-party, then LICENSEE will pay LICENSOR the foregoing
percentages applied to any license fees and royalties received by
LICENSEE or its Affiliate on Net Sales made by such sublicensee.
For the avoidance of doubt, the monthly development support
payments of Section 3.3 and the development and regulatory
milestone payments of Section 3.4 shall remain owed to LICENSOR in
full regardless of any sublicense.
3.3
Monthly Development
Support Payment. At the end of each month, for a term of the
first to occur of eighteen (18) months from the Effective Date or
termination of the Agreement, LICENSEE will pay LICENSOR a
development support payment of ten thousand
dollars ($10,000). Notwithstanding the foregoing, these
monthly support payments are not due or payable for as long as
monthly support payments separately are being made by LICENSEE
under the license agreement between the Parties related to PH94B.
These monthly development support payments shall be creditable
against royalties paid pursuant to Section 3.2.
3.4
Development and
Regulatory-Based Milestone Payments. At such time as
Licensed Product of LICENSEE (or its Affiliates or sublicensees)
first achieves NDA Approval from the FDA and/or EMEA, as described
below, LICENSEE will pay to LICENSOR the milestone payment
specified below. The specified milestone payment(s) shall be made
within twelve (12) months after the occurrence of the milestone
event.
(a)
[*****] upon the
LICENSEE’s NDA Approval by the FDA; and
(b)
[*****] upon the
LICENSEE’s NDA Approval by the EMEA.
3.5
Mode of Payment.
All royalty payments to LICENSOR hereunder shall be made on an
annual basis, in connection with the annual sales report described
in Section 4.3, by wire
___________________
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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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transfer of United
States Dollars in the requisite amount to such bank account as
LICENSOR may designate by notice to LICENSEE. Payments shall be
free and clear of any taxes (other than withholding and other taxes
imposed on LICENSEE), fees or charges, to the extent applicable.
The amount of Net Sales in any country in the Territory outside of
the United States shall be converted into United States Dollars, by
applying the buying rate for the applicable day of conversion as
published by Wall Street Journal on the last business day of the
applicable period.
3.6
Third-Party
Royalties. If LICENSEE is obligated to pay a royalty to one
or more third-parties for Licensed Product, the royalty obligation
of Section 3.2 shall be reduced by one half (1/2) of the
third-party obligation effective on the date on which royalties are
first due under the agreement with the third party. Notwithstanding
the foregoing, in no event shall the royalty obligation under
Section 3.2 be reduced below [*****].
3.7
Applicable Royalty.
Only one royalty obligation shall be applicable to Licensed Product
regardless of whether one or more Valid Patent Claims or regulatory
exclusivity pertains. No royalty obligation shall be due under this
Agreement in the event that a manufacturing sublicense is granted
by LICENSEE, its Affiliates or sublicensees.
Article
4.
OBLIGATIONS OF LICENSEE
4.1
Commercialization.
LICENSEE agrees to use its reasonable best efforts to Develop and
Commercialize Licensed Product in the Territory as soon as
practicable, consistent with sound business practices and
judgment.
4.2
Annual Progress
Reports. LICENSEE shall provide LICENSOR with written annual
reports within sixty (60) days after the end of each calendar year
during the term of this Agreement to report on LICENSEE’s
progress in developing and marketing Licensed Product. The
obligation to submit such progress reports shall end upon the First
Commercial Sale of Licensed Product.
4.3
Annual Sales
Reports. LICENSEE shall provide LICENSOR with written annual
reports within sixty (60) days after the end of each calendar year
during the term of this Agreement to report on Net
Sales.
4.4
Records. LICENSEE
shall keep complete, accurate and correct records of Net Sales in
sufficient and appropriate detail to determine the amount of
royalties due to LICENSOR. Such records shall be available for
inspection and maintained for a period of three (3) years after the
payment of any such royalty. LICENSEE shall permit such books and
records to be examined at a reasonable time during normal business
hours by a certified public accountant chosen by LICENSOR and
reasonably acceptable to LICENSEE for the purpose only of verifying
the reports and payments required by this Agreement. Such
examination shall be made at the expense of the
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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4.5
Compliance with Applicable
Law. LICENSEE agrees to comply with all applicable federal,
state and local laws that relate to the manufacture and sale of
Licensed Product.
Article
5.
CONFIDENTIALITY
5.1
Confidential
Information. Except as expressly provided herein, the
Parties agree that, for the term of this Agreement and for five (5)
years thereafter, the receiving Party shall keep completely
confidential and shall not publish or otherwise disclose and shall
not use for any purpose except for the purposes
contemplated by this Agreement any Confidential Information
furnished to it by the
disclosing Party pursuant to this Agreement, except to the extent
that it can be established by the receiving Party
by competent proof that such Confidential Information:
(a)
was already known to the receiving Party, other than under an
obligation of confidentiality to the disclosing Party, 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 subsequently lawfully disclosed to the receiving Party by a
person other than a Party; or
(e)
was independently developed by the receiving Party.
5.2
Permitted Use and
Disclosures. Each Party may use or disclose Confidential
Information disclosed to it by the other Party, under substantially
similar obligations of confidentiality, to the extent such use or
disclosure is reasonably necessary in raising capital; negotiating
marketing, manufacturing or product development arrangements; in
connection with a potential sale of the company; defending
litigation; complying with applicable governmental regulations or
otherwise submitting information to tax or other governmental
authorities; working with its outside accounting firm; provided,
however, that if a Party is required to make any such disclosure of
another Party's Confidential Information, other than pursuant to a
confidentiality agreement, it will give reasonable advance notice
to the latter Party of such disclosure and will use its best
efforts to cooperate with the said latter Party’s attempts to
secure confidential treatment of such information (including the
significant financial terms of this Agreement) prior to its
disclosure (whether through protective orders or otherwise) and
disclose such information only to the minimum extent necessary to
comply with such requirements.
Article
6.
PATENTS
6.1
LICENSOR Licensed
Patents.
LICENSEE shall prepare, file, prosecute and maintain the Licensed
Patents in the Territory at LICENSEE’s expense. LICENSEE
agrees to keep LICENSOR fully advised of the status of all Licensed
Patents; and will provide LICENSOR with a reasonable opportunity to
comment on the preparation, filing, prosecution,
___________________
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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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maintenance, and
seeking extensions of the Licensed Patents. LICENSOR agrees to
cooperate with LICENSEE in such patent-related activities at
LICENSEE’s reasonable request and expense.
Article
7.
INFRINGEMENT
7.1
Notice of Infringement by
Third Parties. In the event that any third-party
infringement of any of the Licensed Patents comes to the attention
of either Party to this Agreement, that Party shall promptly notify
the other Party.
7.2
Actions for
Infringement. If
any Valid Claim of the Licensed Patents is infringed by a third
party in the Territory, LICENSEE shall have the right and option,
but not the obligation, to commence appropriate legal action
to enjoin such infringement, at LICENSEE’s expense,
against such third-party in the name of LICENSOR, its Affiliates or
assignees. If LICENSEE fails to initiate such action within
ninety (90) days after being notified of the infringement, LICENSOR
shall have the right, but not the obligation, to undertake such
action at its own expense, and LICENSEE agrees to cooperate with
LICENSOR, at LICENSOR’s expense. LICENSEE shall promptly notify
LICENSOR of any infringement action that it brings pursuant to this
Article 7, and shall keep LICENSOR informed as to the prosecution
of any action for each such infringement. In either case,
the other Party may participate in such infringement action at its
own expense and may be represented by counsel of its
choice.
7.3
Recovery of
Damages. Any damages or awards resulting from the
prosecution of such infringement claims shall be applied first, to
reimburse the prosecuting party for its costs and expenses, and
second to reimburse the participating party for its costs and
expenses, with any balance to be shared by the Parties in
proportion to their respective economic losses from such
infringement. No
settlement, consent judgment or other voluntary final disposition
which would adversely affect the Licensed Patents may be entered
into by LICENSOR without the consent of LICENSEE, which consent
shall not be unreasonably withheld.
7.4
Cooperation. Each of the
Parties shall cooperate with the others in respect of any claim or
action relating to the Licensed Patents, such cooperation to
include, without limitation, making available, upon reasonable
request, such of its employees, records, papers, information,
samples, specimens and the like as may be reasonably requested by
the other Party.
7.5
Infringement of
Third-Party Patents. In the event that either Party becomes
aware that LICENSEE’s activities pursuant to the Agreement
might infringe the patents of any third party, that Party shall
promptly notify the other Party. In such event, the Parties agree
to discuss in good faith how to respond to such potential
infringement liability. Absent agreement to the contrary,
LICENSEE shall have the
right and option, but not the obligation, to defend against
any asserted infringement challenge at its own expense and in the name
of LICENSOR, its Affiliates or assignees. Neither Party has
the right to accept any judgment or enter into any settlement or
otherwise dispose of any infringement claim made by a third party
without the
___________________
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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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prior written
consent of the other Party (which consent shall not be unreasonably
withheld, conditioned or delayed).
Article
8.
REPRESENTATIONS AND WARRANTIES
8.1
Authority. Each
Party represents and warrants that it has the full right, power and
authority to execute, deliver and perform its obligations pursuant
to this Agreement.
8.2
No Conflicts. Each
Party represents and warrants that the execution, delivery and
performance of this Agreement does not conflict with, or constitute
a breach or default under any of its charter or organizational
documents, any law, order, judgment or governmental rule or
regulation applicable to it, or any material agreement, contract,
commitment or instrument to which it is a party.
8.3
No Existing Third-Party
Rights. The Parties represent and warrant that their
obligations under this Agreement are not encumbered by any rights
granted by either Party to any third parties, and that to their
knowledge no third party has made any claim or asserted any right
to the Licensed IP or Licensed Product including pending, settled
or threatened litigation or regulatory challenges.
8.4
Continuing
Representations. The representations and warranties of each
Party contained in this Article 8 shall survive the execution and
delivery of this Agreement and shall remain true and correct at all
times during the term of this Agreement with the same effect as if
made on and as of such later date.
8.5
Disclaimer of
Warranties. LICENSOR MAKES NO REPRESENTATIONS AND EXTENDS NO
WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED,
WITH RESPECT TO LICENSED PRODUCT INCLUDING, BUT NOT LIMITED TO,
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
8.6
Patent Warranties by
LICENSOR. (a) LICENSOR does not know of any United States
patent or patent application, or foreign counterpart, whether or
not owned or licensed to LICENSOR, that might be infringed by the
exercise by LICENSEE of its rights to Licensed Product under this
Agreement other than Licensed Patents. (b) LICENSOR warrants that
it has obtained from the inventors of the Licensed IP valid and
enforceable agreements assigning to LICENSOR each such
inventor’s entire right, title and interest under the
applicable employee intellectual property law. (c) LICENSOR does
not know of any reason why the Licensed Patents would be
unallowable, invalid or unenforceable. (d) It is expressly
understood, however, that in making the conveyances and grants
under this Agreement, with the exception of the foregoing
provisions of this paragraph, LICENSOR makes no representations,
extends no warranties, express or implied, and assumes no
responsibilities whatsoever, with respect to the scope or validity
of any Licensed Patents, or relating to any use of Licensed Product
as being free from infringement of patents other than 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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Article
9.
TERM AND TERMINATION
9.1
Term. This
Agreement will begin on the Effective Date and expire on a
country‐by‐country basis on the date that Net Sales end
in such country. For the avoidance of doubt, following such
expiration, the license in such country will be fully paid up,
irrevocable and perpetual.
9.2
Termination by LICENSEE
for Convenience. LICENSEE may terminate this Agreement
without cause upon one hundred eighty (180) days written notice to
LICENSOR, in the entire Territory or on a country-by-country
basis.
9.3
Termination for
Breach. The failure by a Party to comply with any of the
material obligations contained in this Agreement shall entitle the
Party not in default to give notice to have the default cured. If
such default is not cured within sixty (60) days after the receipt
of such notice, or diligent steps are not taken to cure if by its
nature such default could not be cured within sixty (60) days, the
Party not in default shall be entitled, without prejudice to any of
its other rights conferred on it by this Agreement, and in addition
to any other remedies that may be available to it, to terminate
this Agreement, provided,
however, that such right to terminate shall be stayed in the
event that, during such 60 day period, the Party alleged to have
been in default shall have: (i) initiated arbitration in accordance
with Section 10.1, below, with respect to the alleged default, and
(ii) diligently and in good faith co-operated in the prompt
resolution of such arbitration proceedings.
9.4
No Waiver. The
right of a Party to terminate this Agreement, as hereinabove
provided, shall not be affected in any way by its waiver or failure
to take action with respect to any prior default.
9.5.
Insolvency or
Bankruptcy. Either Party may, in addition to any other
remedies available under this Agreement, terminate this Agreement
by written notice to the other Party in the event the latter Party
shall have become insolvent or bankrupt, or shall have an
assignment for the benefit of its creditors, or there shall have
been appointed a trustee or receiver of the other Party or for all
or a substantial part of its property or any case or proceeding
shall have been commenced or other action taken by or against the
other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement or readjustment of its debts
or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction now
or hereafter in effect, or there shall have been issued a warrant
of attachment, execution, distraint or similar process against any
substantial part of the property of the other Party, and any such
event shall have continued for 90 days undismissed, unbonded and
undischarged.
9.6
Effect of Termination by
LICENSEE Pursuant to Section 9.2. On termination of this
Agreement by LICENSEE pursuant to Section 9.2 in any given country,
within 30 days after notice from LICENSOR and at LICENSOR’s
expense, LICENSEE will, for such country: (a)
___________________
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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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transfer ownership
of and rights under any regulatory filings in such country for the
Licensed Product to LICENSOR, and (b) with input and direction
from LICENSOR, complete all relevant activities related to such
regulatory filings, including the submission of relevant notices to
the relevant Regulatory Authorities, in form and substance
satisfactory to LICENSOR, as required for LICENSOR to assume such
ownership and rights, as applicable. Promptly after such
termination, if requested by LICENSOR, LICENSEE will also
(i) send letters (in form and substance satisfactory to
LICENSOR) to the FDA and other Regulatory Authorities in such
country indicating that any other Regulatory Documents are
transferred to LICENSOR and that LICENSOR is the new owner of the
Regulatory Documents as of the Effective Date, (ii) send
letters to all applicable IRBs or other relevant entities and
similar committees to direct product-related communications to
LICENSOR commencing on the date of termination, and (iii) provide
to LICENSOR a copy of such letters. LICENSEE will also grant to
LICENSOR an irrevocable, fully-paid license in such country to all
Improvements made by LICENSEE and its Affiliates.
9.7
Limitation on
Remedies. LICENSEE’s remedies for uncured material
breach by LICENSOR shall be limited to (1) termination of this
Agreement, in the entire Territory or on a country-by-country
basis, and/or (2) the right to claim damages caused by that breach
solely from LICENSOR. LICENSEE waives any rights against any former
officer or director of LICENSOR in their capacity as such, as of
the Effective Date, and against any current or former shareholder
of LICENSOR, in their capacity as such, including any current or
former holder of convertible notes of LICENSOR (collectively, the
“Waived Parties”). LICENSEE agrees that it will
initiate no dispute resolution proceeding against the Waived
Parties; and no arbitration panel appointed under Article 10 shall
have the ability to make any award against the Waived
Parties.
9.8
Survival of
Obligations. The termination of this Agreement shall not
relieve the Parties of any obligations accruing prior to such
termination, and any such termination shall be without prejudice to
the rights of either Party against the other, subject to the
limitations of Section 9.7 above. The provisions of Sections 4.3 to
4.5, Articles 5, 7, 8, 10 and 11 shall survive any termination of
this Agreement.
Article
10.
DISPUTE RESOLUTION
10.1
Dispute
Resolution. Any dispute concerning or
arising out of this Agreement or concerning the existence or
validity hereof, shall be determined by the following
procedure.
(a) Both
Parties understand and appreciate that their long-term mutual
interest will be best served by affecting a rapid and fair
resolution of any claims or disputes which may arise out of
services performed under this contract or from any dispute
concerning the terms of this Agreement. Therefore, both Parties
agree to use their best efforts to resolve all such disputes as
rapidly as possible on a fair and equitable basis. Toward this end
both Parties agree to develop and follow a process for presenting,
rapidly assessing, and settling claims on a fair and equitable
basis which takes into account the precise subject and nature of
the dispute.
(b) If any
dispute or claim arising under this Agreement cannot be readily
resolved by the Parties pursuant to the process described above,
the Parties agree to refer the
___________________
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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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matter
to a panel consisting of the Chief Executive Officer
(“CEO”) of each Party for review and a non-binding
resolution. A copy of the terms of this Agreement, agreed upon
facts (and areas of disagreement), and concise summary of the basis
for each side’s contentions will be provided to both such
CEOs who shall review the same, confer, and attempt to reach a
mutual resolution of the issue.
(c) If the
matter has not been resolved utilizing the foregoing process, and
the Parties are unwilling to accept the non-binding decision of the
indicated panel, either or both Parties may elect to pursue
definitive resolution through binding arbitration, which the
Parties agree to accept in lieu of litigation or other legally
available remedies (with the exception of injunctive relief where
such relief is necessary to protect a Party from irreparable harm
pending the outcome of any such arbitration proceeding). Binding
arbitration shall be settled in accordance with the Rules of
Conciliation and Arbitration of the International Chamber of
Commerce by a panel of three arbitrators chosen in accordance with
said Rules. This Agreement shall be governed by and construed in
accordance with the substantive laws of the State of California
without regard to the conflicts of laws provision thereof. The
arbitration will be held in San Francisco, California, if initiated
by LICENSEE or LICENSOR. Judgment upon the award rendered may be
entered in any court having jurisdiction and the Parties hereby
consent to the said jurisdiction and venue, and further irrevocably
waive any objection which either Party may have now or hereafter to
the laying of venue of any proceedings in said courts and to any
claim that such proceedings have been brought in an inconvenient
forum, and further irrevocably agrees that a judgment or order in
any such proceedings shall be conclusive and binding upon the
Parties and may be enforced in the courts of any other jurisdiction
thereof.
Article
11.
INDEMNIFICATION
11.1
Indemnification of
LICENSEE. LICENSOR shall indemnify and defend LICENSEE and
its Affiliates, and the directors, officers, employees, agents and
counsel of LICENSEE and such Affiliates, and the successors and
assigns of any of the foregoing (the “LICENSEE
Indemnitees”), and hold the LICENSEE Indemnitees harmless
from and against any and all claims, liabilities, damages, losses,
costs or expenses (including reasonable attorneys’ fees and
professional fees and other expenses of litigation) (collectively,
“Losses”) resulting from any claim, suit or proceeding
brought by a third party against a LICENSEE Indemnitee, arising
from or occurring as a result of any breach of a representation or
warranty by LICENSOR or of a material obligation of LICENSOR under
this Agreement or the negligence or willful misconduct of LICENSOR
in connection with the performance of its obligations under this
Agreement, except to the extent caused by the negligence or willful
misconduct of LICENSEE.
11.2
Indemnification of
LICENSOR. LICENSEE shall indemnify and defend LICENSOR and
its Affiliates and the directors, officers, employees, agents and
counsel of LICENSOR and such Affiliates and the successors and
assigns of any of the foregoing (the “LICENSOR
Indemnitees”), and hold the LICENSOR Indemnitees harmless
from and against any and all Losses resulting from any claim, suit
or proceeding brought by a third party against a LICENSOR
Indemnitee, arising from or occurring as a result of any breach of
a representation or
___________________
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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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warranty by
LICENSEE or of a material obligation of LICENSEE under this
Agreement; the use, handling, storage, disposal or experimentation
with Licensed Product by LICENSEE; the negligence or willful
misconduct of LICENSEE in connection with the performance of its
obligations under this Agreement; or the manufacture, import, use,
offer for sale or sale of Licensed Product, except to the extent
caused by the negligence or willful misconduct of
LICENSOR.
11.3
Procedure. A Party
(the “Indemnitee”) that intends to claim
indemnification under this Article 11 shall promptly notify the
other Party (the “Indemnitor”) in writing of any Loss
in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall have the right to
participate in, and, to the extent the Indemnitor so desires, to
assume the defense thereof with counsel mutually satisfactory to
the Parties; provided, however, that an Indemnitee shall have the
right to retain its own counsel, with the fees and expenses to be
paid by the Indemnitor, if representation of such Indemnitee by the
counsel retained by the Indemnitor would be inappropriate due to
actual or potential differing interests between such Indemnitee and
the Indemnitor in such proceeding. The Indemnitor shall control the
defense and/or settlement of any such Loss, and the indemnity
agreement in this Article 11 shall not apply to amounts paid in
connection with any Loss if such payments are made without the
consent of the Indemnitor, which consent shall not be withheld
unreasonably. The failure to deliver written notice to the
Indemnitor within a reasonable time after the commencement of any
such action, if prejudicial to its ability to defend such action,
shall relieve such Indemnitor of any liability to the Indemnitee
under this Article 11. At the Indemnitor’s request, the
Indemnitee under this Article 11, and its employees and agents,
shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any Loss covered by this
indemnification and provide true, correct and complete information
with respect thereto.
11.4
Insurance. LICENSEE
will procure and maintain insurance issued by a reputable insurance
company, which policy will insure against any and all claims,
liabilities, costs, fees and expenses resulting from or caused by
(or claimed to be resulting from or caused by) use of the Licensed
Product in the Territory, with a limit of liability per occurrence
of at least an amount equal to Ten Million U.S. Dollars (US$ 10
million). It is understood that such insurance will not be
construed to create a limit of LICENSEE’s liability with
respect to its indemnification obligations under Section 11.2.
LICENSEE will provide LICENSOR with written evidence of such
insurance upon request, and will provide LICENSOR with written
notice at least 30 days prior to the cancellation, non-renewal or
material change in such insurance.
Article
12.
MISCELLANEOUS
12.1
Governing Law. This
Agreement and any dispute arising from the performance or breach
hereof shall be governed by and construed and enforced in
accordance with the laws of the State of California as applied to
disputes involving parties located entirely within the State and
also without reference to the State’s conflicts of laws
principles.
___________________
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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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12.2
Waiver. Neither
Party may waive or release any of its rights or interests in this
Agreement except in writing. The failure of either Party to assert
a right hereunder or to insist upon compliance with any term or
condition of this Agreement shall not constitute a waiver of that
right or excuse a similar subsequent failure to perform any such
term or condition.
12.3
Assignability.
Neither Party may assign its rights under this Agreement without
the prior written consent of the other Party, such consent not to
be unreasonably withheld. Notwithstanding the foregoing, LICENSEE
may assign it rights under this Agreement to a successor in
connection with a merger, consolidation, spin-off or sale of all or
substantially all of its assets or that portion of its business
pertaining to subject matter of this Agreement, without prior
written consent of LICENSOR.
12.4
Notices. All
notices, requests and other communications hereunder shall be in
writing and shall be personally delivered or sent by courier or by
registered or certified mail, return receipt requested, postage
prepaid, in each case to the respective address specified below, or
such other address as may be specified in writing to the other
Parties hereto:
LICENSEE:
VistaGen Therapeutics,
Inc.
000
Xxxxxxxx Xxxxxx
Xxxxx
Xxx Xxxxxxxxx, XX 00000
Phone:
000-000-0000
Fax:
000-000-0000
ATTN:
Xxxxx Xxxxx, Chief Executive Officer
with a
required copy to:
Xxxx
Xxxxx, Esq.
Law
Office of Reid G. Xxxxx, XX
0000
Xxxxxxx Xxxx, Xxxxx 000
Xxxxxxxx, XX
00000
Phone:
(000)-000-0000
Fax:
(000)-000-0000
LICENSOR:
Pherin Pharmaceuticals, Inc.
XX Xxx
0000
Xxx
Xxxxx, XX 00000
Phone:
000-000-0000
ATTN:
Xx. Xxxxx Xxxxx, Executive VP
with a
required copy 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.
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Xxx X.
Xxxxxx, Xxx.
Xxxxxxxx, XxXxxxxxx
& Cha, LLP
0000 Xx
Xxxxxx Xxxx, Xxxxx 000
Xxxx
Xxxx, XX 00000
Phone:
000-000-0000
12.5
Force Majeure.
Neither Party shall be liable to the other for failure or delay in
the performance of any of its obligations under this Agreement for
the time and to the extent such failure or delay is caused by
riots, civil commotions, wars, hostilities between nations,
embargoes, actions by a government or any agency thereof, acts of
God, storms, fires, accidents, sabotage, explosions or other
similar or different contingencies, the damage or harm resulting
from any or all of which, in each case, shall be beyond the
reasonable control of the Party invoking this Section 12.5 and not
attributable to the negligence or willful misconduct of the Party
invoking this Section 12.5. The Party affected by force majeure
shall provide the other Party with full particulars thereof as soon
as it becomes aware of the same (including its best estimate of the
likely extent and duration of the interference with its
activities), and will use reasonable efforts to overcome the
difficulties created thereby and to resume performance of its
obligations as soon as practicable. If the performance of any
obligation under this Agreement is delayed owing to a force majeure
event for any continuous period of more than six (6) months, the
Parties hereto shall consult with respect to an equitable solution,
including the possible termination of this Agreement.
12.6
Independent
Contractor. Both Parties are independent contractors under
this Agreement. Nothing contained in this Agreement is intended nor
is to be construed so as to constitute LICENSOR or LICENSEE as
partners or joint venturers with respect to this Agreement. Neither
Party shall have any express or implied right or authority to
assume or create any obligations on behalf of or in the name of the
other Party or to bind the other Party to any other contract,
agreement, or undertaking with any Third Party.
12.7
Use of
Name. The
Parties may disclose the existence and general natures of this
Agreement, and LICENSEE may use the name of LICENSOR for
promotional and regulatory compliance purposes, as necessary and
appropriate to advance Development of Licensed
Product.
12.8
Trademarks. Nothing
contained in this Agreement shall be construed as conferring any
right to use in advertising, publicity or other promotion
activities any name, trade name, trademark or other designation of
any Party (including any contraction, abbreviation or
simplification of any of the foregoing). LICENSEE, its Affiliates
and sublicensees shall have the right to market Licensed Product
under their own labels and trademarks. LICENSEE agrees to xxxx and
have its Affiliates and sublicensees xxxx all Licensed Product that
they sell or distribute pursuant to this Agreement in accordance
with the applicable statute or regulations in the country or
countries of manufacture and sale thereof.
___________________
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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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12.9
Severability. If
any provision of this Agreement becomes or is declared by a court
of competent jurisdiction to be illegal, unenforceable or void,
this Agreement shall continue in full force and effect without said
provision, so long as the Agreement, taking into account said
voided provision(s), continues to provide the Parties with the same
practical economic benefits as the Agreement containing said voided
provision(s) did on the date of this Agreement. If, after taking
into account said voided provision(s), the Parties are unable to
realize the practical economic benefit contemplated on the date of
this Agreement, the Parties shall negotiate in good faith to amend
this Agreement to reestablish the practical economic benefit
provided the Parties on the date of this Agreement.
12.10
No Implied
Licenses. No rights or licenses with respect to any LICENSOR
patents or know-how, other than as explicitly identified above, are
granted or deemed granted hereunder or in connection herewith other
than those rights expressly granted in this Agreement.
12.11
Complete Agreement.
This Agreement, including Schedule 1, shall constitute the entire
agreement, both written and oral, between the Parties with respect
to the subject matter hereof, and all prior agreements respecting
the subject matter hereof, either written or oral, expressed or
implied, are merged and canceled, and are null and void and of no
effect. No amendment or change hereof or addition hereto shall be
effective or binding on either of the Parties hereto unless reduced
to writing and duly executed on behalf of both
Parties.
12.12
Headings. The
captions to the sections and articles in this Agreement are not a
part of this Agreement but are included merely for convenience of
reference only and shall not affect its meaning or
interpretation.
12.13
Counterparts and
Signatures. This Agreement may be executed in counterparts,
or facsimile versions, each of which shall be deemed to be an
original, and both of which together shall be deemed to be one and
the same agreement. Signatures to this Agreement transmitted by
facsimile transmission, by electronic mail in “portable
document format” (“.pdf”) form, or by any other
electronic means intended to preserve the original graphic and
pictorial appearance of a document, will have the same effect as
physical delivery of the paper document bearing the original
signature.
12.14
Binding Effect.
This Agreement and the license granted herein shall be binding upon
and shall inure to the benefit of LICENSOR, LICENSEE and their
successors and permitted assigns.
12.15
Advice of Counsel and
Expenses. LICENSEE and LICENSOR have each consulted with
counsel of their choice regarding this Agreement, and each
acknowledges and agrees that this Agreement shall not be deemed to
have been drafted by one party or another and will be construed
accordingly. Except as otherwise expressly provided in this
Agreement, each Party shall pay the fees and expenses of its
respective attorneys and all other expenses and costs incurred by
such Party incidental to the negotiation, preparation, execution
and delivery 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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12.16
Further Assurance. Each Party shall perform all further acts and
execute and deliver such further documents as may be necessary or
as the other Party may reasonably require to give effect to this
Agreement.
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to
be duly executed by their authorized representatives as of the date
first above written.
VistaGen
Therapeutics,
Inc.
Pherin Pharmaceuticals, Inc.
By:__________________________
By:_________________________
Name: Xxxxx
Xxxxx
Name: Xxxxx Xxxxx, MD, PhD
Title: Chief
Executive
Officer
Title: Executive
Vice President
___________________
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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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Schedule 1: LICENSOR Patent Rights
Patents
to which LICENSOR grants LICENSEE exclusive rights under Section
2.1:
[*****]
___________________
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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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