Document:

Blueprint

 

 
Exhibit 10.138

 

MASTER SERVICES AGREEMENT

(For All CRO Services)

 

 This Master Services Agreement (this “Agreement”)
is made as of the 11th day of July, 2017 (the “Effective
Date”) by and between Cato Research Ltd., a North Carolina corporation headquartered at 4364
South Alston Avenue, Durham, North Carolina, USA 27713
(“CRL”), and VistaGen Therapeutics, Inc., a Nevada
corporation headquartered at 343 Allerton Avenue, South San
Francisco, California 94080, USA (“VistaGen”). Each of
CRL and VistaGen may be referred to herein separately as a
“Party” and collectively as the “Parties.”
As used in this Agreement, “Affiliate(s)” means any
corporation, firm, partnership, or other entity which controls, is
controlled by or is under common control with a Party. For the
purpose of this definition, “control” shall mean the
power to direct, or cause the direction of, the management and
policies of an entity through the ownership, directly or
indirectly, of at least fifty percent (50%) of the voting share
capital of such entity or any other comparable equity, by contract,
or by ownership interest.

 

WHEREAS, VistaGen is engaged in the evaluation,
development, commercialization and/or marketing of biologics,
pharmaceutical agents, medical devices and/or other life sciences
technologies (collectively, “Products”);
and

 

 

WHEREAS, CRL is an independent contract research and
development organization (“CRO”) providing a broad
range of services relating to the evaluation, development,
commercialization and marketing of new biologics, pharmaceutical
agents, medical devices and/or other life sciences technologies;
and

 

WHEREAS, VistaGen wishes to retain CRL, and CRL wishes to
be retained by VistaGen, to assist VistaGen with certain aspects of
the evaluation, development, commercialization or marketing of
VistaGen Products or otherwise to provide certain regulatory or
other strategic consulting services as specified by VistaGen from
time to time; and

 

 NOW, THEREFORE, in
consideration of the foregoing premises and the promises, benefits,
rights, and obligations set forth below, the Parties agree as
follows:

 

1.

Work Orders for CRO
Services.

 

1.1

CRL
shall provide CRO services to VistaGen, as requested by VistaGen
from time to time in accordance with the terms of this Agreement
(the “CRO Services”). Requested CRO Services may
include any area of services customarily undertaken by CRL,
including without limitation the areas of nonclinical development,
clinical development, regulatory affairs, medical monitoring and
pharmacovigilance or safety services.

 

1.2

Whenever VistaGen requests CRL to perform CRO
Services, and CRL wishes to perform CRO Services requested by
VistaGen, CRL shall prepare a Work Order, in a form acceptable to
both Parties and containing, at a minimum, the CRO Services to be
performed and the compensation to be paid by VistaGen for the CRO
Services covered by the Work Order. It may also include any other
requirements or obligations agreed upon by the Parties and not set
forth herein. Each such Work Order, to be binding an effective on
the Parties, shall be executed and delivered by the Parties
before
any CRO Services are rendered
thereunder. If CRL submits a project proposal for CRO Services to
VistaGen, and such project proposal is executed and delivered by
both Parties with the expressed intent reflected in writing therein
that it be performed as a Work Order, then it shall be deemed a
Work Order for purposes of this Agreement. Each Work Order shall be
deemed a part of this Agreement and incorporated into it, but no
Work Order shall be deemed part of another Work Order, unless
specifically so stated in the applicable Work Order executed and
delivered by both Parties.

 

 

 

 

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1.3

CRL
shall not be obligated to perform, and VistaGen shall not be
obligated to pay for, the CRO Services described in any proposal,
draft work order or similar document unless and until such time as
the Work Order related to such CRO Services has been signed and
delivered by both Parties.

 

1.4

If
the terms of a Work Order conflict with those of this Agreement,
then the terms of this Agreement shall control unless otherwise
specifically stated in the Work Order. If either Party sends a
purchase order, confirmation, or similar form, then the terms of
this Agreement and not those in such additional document shall
control; the Parties agree that any additional or different terms
in such form, now or in the future, are void even if the form
indicates that it shall control.

 

1.5

Unless
a Work Order specifies to the contrary, CRL may subcontract some or
all of its obligations under such Work Order to an Affiliate
provided that such Affiliate is bound by confidentiality
obligations at least as protective of VistaGen’s confidential
information as those in this Agreement. CRL shall be equally
responsible for the performance of such Affiliate as CRL would be
if it performed such obligations itself. CRL may use individuals
engaged as independent contractors to perform CRO Services
hereunder provided that CRL remains equally liable for their
conduct as if they were employees. Except for such individuals and
Affiliates, CRL shall not subcontract any of its obligations under
a Work Order to a third party without Vistagen’s
consent.

 

1.6

If
a Work Order is unclear, ambiguous, or permits different
understandings of the CRO Services to be performed, the Parties
shall use good faith efforts to resolve such ambiguity in writing,
it being understood that such resolution may result in an
adjustment to the budgeted costs.

 

1.7

If
the scope or definition of the CRO Services in a Work Order
changes, including without limitation a change in the number of
units of any CRO Services as specified in the budget for the
applicable Work Order, and the additional cost of such additional
CRO Services does not exceed the lesser of (x) ten percent (10%) of
the budget for the CRO Services as set forth in the applicable Work
Order or (y) $50,000, CRL will notify VistaGen of the changes and,
upon VistaGen’s written authorization (which may be by
email), will commence performance of the additional CRO Services
without a formal Work Order amendment. CRL will thereafter
formalize the changes by providing to VistaGen a formal amendment
to the Work Order reflecting the authorized changes. The Parties
shall then timely sign such amendment, but Vistagen shall
nevertheless be obligated to pay for the changed CRO Services based
on the previously- given authorization to proceed even if Vistagen
does not sign the relevant amendment. With respect to changes
requested in excess of the lesser of (x) ten percent (10%) of the
applicable budget or (y) $50,000, neither party shall be obligated
unless and until a prior written Work Order amendment is signed and
delivered by the Parties.

 

1.8

The
parties acknowledge that any change in regulations to which the CRO
Services are subject may require an amendment to the relevant Work
Order, and that some changes to regulations may render the
underlying project economically or practically infeasible and, in
such instances, the parties will work together to negotiate an
appropriate amendment to the Work Order to wind-down the CRO
Services efficiently.

 

 

 

 

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1.9

Unless
specifically included in an applicable Work Order, CRL will not
collect or report to VistaGen any payments made which may be
reportable under the Physicians Payment Sunshine Act. If collection
and reporting obligations are specified in an applicable Work
Order, CRL shall report the required information based no payments
made by CRL, and CRL shall have no obligations with respect to any
payments made by VistaGen; VistaGen shall aggregate its own
information from all sources and make its report to the Centers for
Medicare and Medicaid Services.

 

1.10

Subject
to the terms of Section 1.7 or 1.8, a Work Order may only be
amended in writing with the signature of both Parties.

 

2.

Performance of CRO
Services.

 

2.1

CRL
shall use commercially reasonable efforts to perform the CRO
Services in accordance with the specifications, instructions, and
guidelines in each Work Order and this Agreement in all material
respects. CRL shall use its own protocols in the performance of CRO
Services unless specified to the contrary in the applicable Work
Order.

 

2.2

All
CRO Services performed by CRL shall be performed in conformity with
all applicable international, federal, state and local laws and
regulations, including without limitation, as applicable, current
Good Laboratory Practices, Good Manufacturing Practices, Good
Clinical Practices, ICH Guidelines, and all applicable FDA
regulations.

 

3.

VistaGen
Obligations. VistaGen shall
undertake the following obligations with respect to the performance
of this Agreement, in addition to any other obligations outlined
herein or in the applicable Work Order.

 

3.1

VistaGen
shall use commercially reasonable efforts to deliver all
information and materials reasonably required for CRL’s
performance of CRO Services in accordance with mutually agreed upon
timelines.

 

3.2

VistaGen
shall immediately inform CRL of any safety concerns or serious
adverse events related to a Product that is the subject of the CRO
Services.

 

3.3

VistaGen
shall use commercially reasonable efforts to not take any actions
or participate in any activities that are intended to, or can be
reasonably expected to, disrupt or interfere with CRL’s
obligations under this Agreement.

 

3.4

CRL
believes all data, information and analysis provided and all
reports generated as Deliverables (as defined below) will be
accurate and reliable, but VistaGen is ultimately and solely
responsible for its use of the Deliverables or other matter or
information produced or provided under this Agreement.

 

 

 

 

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4.

Compensation.

 

4.1

VistaGen
shall pay CRL for the CRO Services as specified in the Work Order
governing such CRO Services. If travel time is not included in the
applicable unit price on the Work Order, then it shall be billed as
out of scope work time, with the understanding that, to the extent
practical, travel time shall be used to perform CRO Services for
VistaGen.

 

4.2

Unless
otherwise specified in the applicable Work Order, VistaGen shall
reimburse CRL for out-of-pocket expenses reasonably incurred in
performance of the CRO Services under this Agreement including, but
not limited to, third-party fees and expenses, passthrough
expenses, telephone, facsimile, messenger, postage and other
communication costs, document copying and retrieval, on-site and
off-site storage fees, computer research fees and filing fees,
reasonable transportation, lodging, and meal expenses for travel to
sites away from CRL’s office, and travel between CRL offices
(collectively, “Expenses”); provided however, that
advanced written approval is required from VistaGen for any Expense
which exceeds five hundred dollars ($500).

 

4.3

Invoices
for CRO Services and Expenses shall be in United States dollars
unless the Work Order related to such CRO Services or Expenses
specifies a different currency shall be sent monthly, and shall
itemize the CRO Services performed and Expenses incurred. VistaGen
shall pay all invoices in the currency of the invoice within thirty
(30) days of the date of the invoice via wire transfer, per wire
instructions which shall be provided by CRL. In addition to paying
the amount due with respect to CRO Services and Expenses, VistaGen
shall also make additional payments for any federal, state, county,
local or governmental taxes, duties, excise taxes, now or hereafter
applied including sales tax, value added tax, or any similar tax.
No deduction shall be made from the amount due or paid as a result
of any taxes or withholding that may occur by governments with
respect to payments made to CRL from outside the United States or
as a result of any taxes paid by VistaGen. Except as specified in
Section 4.4, payment shall be in the full amount specified on the
invoice.

 

4.4

If
VistaGen disputes the amount due on any invoice, then VistaGen must
notify CRL of such dispute before the payment due date and pay such
amount as is undisputed by the payment due date. Both Parties shall
act in good faith to promptly resolve such dispute, and upon
resolution of the dispute, any amount remaining due shall be paid
within fifteen (15) days after the resolution.

 

4.5

If
all or any undisputed portion of an invoice remains unpaid when
due, then such unpaid portion shall accrue a finance charge of
1.25% per month from the date of the invoice until paid. For the
avoidance of confusion, in calculating finance charges related to
disputed invoices, an invoice (or portions thereof, as applicable)
shall be deemed to have been due such that finance charges begin to
accrue: (a) thirty (30) days after the date of the original invoice
if the invoice is determined to have been correct; or (b) if the
dispute relates to incomplete or incorrect work then fifteen (15)
days after the date on which it is determined all obligations for
payment of each disputed amount were met under the Work Order such
that payment of such amount should have been made. VistaGen shall
reimburse CRL on demand for all reasonable out-of-pocket costs and
expenses CRL incurs in enforcing payment of an overdue invoice,
including, without limitation, attorneys’ fees and expenses.
Payments received from VistaGen by CRL on an overdue invoice shall
be first applied to costs of collection, then to accrued interest,
and then to the unpaid balance of the invoice. CRL may, in its
discretion, allocate collection costs among any overdue invoices
and apply any payments received against any overdue
invoices.

 

 

 

 

 

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4.6

Except
as otherwise set forth herein, any and all payments made hereunder
are nonrefundable.

5.

Term and
Termination.

 

5.1

The
term of this Agreement shall be five (5) years from the Effective
Date and it shall automatically renew for additional one (1) year
terms unless, at least sixty (60) days before the expiration of any
term, a Party gives written notice to the other Party that it does
not want to renew this Agreement; provided however, that if the
term of a Work Order extends beyond the term of this Agreement,
then this Agreement will continue in effect as to that Work Order
(only) until the completion or termination of such Work Order and
all wind-down CRO Services related to such Work Order.

 

5.2

Either
Party may terminate a Work Order upon the other Party’s
material default under this Agreement with respect to such Work
Order, provided that the terminating Party has given the defaulting
Party not less than thirty (30) days’ prior written notice of
such default and the defaulting Party has not cured such default by
the end of the notice period. Termination of a Work Order based on
an uncured default does not give rise to the right to terminate any
other Work Order or this Agreement.

 

5.3

Except
with respect to Work Orders for clinical trials, either Party may
terminate a Work Order at any time upon no less than thirty (30)
days’ prior written notice to the other Party. With respect
to Work Orders for clinical trials, only VistaGen may terminate at
any time upon no less than sixty (60) days’ prior written
notice to CRL.

 

5.4

Upon
early termination of a Work Order, CRL shall invoice VistaGen and
VistaGen shall pay CRL for all CRO Services rendered and Expenses
incurred through the date of termination in accordance with Section
4 above. CRL’s compensation under any Work Order being paid
on a fixed-fee basis or on any payment schedule which is other than
either time-and materials or a unit-based budget, the Work Order
shall be converted to a time-and-materials basis in accordance with
CRL’s current rates, and CRL shall be paid for all CRO
Services performed and Expenses incurred through the date of
termination.

 

5.5

If
VistaGen terminates a Work Order under Section 5.3 or CRL
terminates a Work Order under Section 5.2, then, in addition to
payments made under Section 5.4, then (a) VistaGen shall reimburse
CRL for any and all non-cancelable obligations of CRL to third
parties related to the terminated Work Order and (b) if the
terminated Work Order relates to a clinical trial, then VistaGen
shall pay CRL the Termination Fee (if any) for such Work Order, as
described in Section 5.6.

 

5.6

The
Termination Fee for a work order shall be computed as
follows:

 

The Termination Fee shall be twenty-five percent (25%) of the
estimated remaining unbilled amounts for CRO Services (but
excluding any pass-through costs or or Expenses) under the Work
Order if either:

 

(a)

the
clinical trial to which the Work Order relates is terminated either
in anticipation of or following a Change of Control (as defined
below), or

 

(b)

Vistagen
does not undertake a new clinical trial within three (3) months of
the date of termination where, in connection with such trial,
Vistagen enters into a new Work Order with CRL providing for
similar services (in description, price and quantity) as specified
in the original terminated Work Order.

 

 

 

 

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As
used above, a “Change of Control” means any event or
series of events by which (a) any person or group of related
persons acquires shares representing fifty percent (50%) of the
outstanding voting power of VistaGen (b) any merger, share exchange
or simiar transaction of VistaGen with another entity in which the
holders of VistaGen shares representing the majority of the voting
power of VistaGen (as measured before the relevant events) do not
hold shares representing the majority of the voting power of the
resulting entity (as measured after the resulting events); or (c) a
sale of the assets of VistaGen to which the Work Order
relates.

 

The
Termination Fee shall be $0 if neither (a) nor (b), above,
apply.

  

5.7

Upon
early termination of a Work Order, CRL shall inform VistaGen of the
extent to which it expects work in progress to be completed as of
the termination date and CRL shall (unless otherwise instructed by
VistaGen) take steps to wind-down work in progress in an orderly
fashion. In addition to all other amounts payable to CRL, VistaGen
shall pay CRL for such winddown CRO Services on a
time-and-materials basis at CRL’s current rates for all
reasonable and customary wind-down CRO Services performed and
Expenses incurred by CRL. If VistaGen instructs CRL not to complete
such wind-down CRO Services, CRL shall, upon notification of the
termination of the Work Order, promptly cease providing CRO
Services and incurring costs to the extent practicable. In any such
event, VistaGen shall be deemed to have released CRL from all legal
liability and to have covenanted not to sue CRL on any claims
related to failure to perform and the failure to complete
reasonable and customary wind-down CRO Services.

 

5.8

In
addition to termination of this Agreement under Sections 5.1-5.3,
at any time CRO Services under all Work Orders have been completed
or terminated such that there is no request for CRO Services
pending, either Party may terminate this Agreement by giving
written notice of termination to the other Party.

 

5.9

The
remedies set forth in this Section 5 are not meant to limit any
additional remedies available to a Party for breach of this
Agreement by the other Party.

 

6.

Suspension of CRO Services.

 

6.1

If
VistaGen should, for any reason, suspend the CRO Services to be
provided under any Work Order for a period of thirty (30) days,
then at the end of such thirty (30) day period CRL may invoice
VistaGen and VistaGen shall pay for all CRO Services which have
been performed through the date of suspension which have not been
invoiced previously. For any Work Order being paid on a unit-based
budget basis, payment shall be made for each partially completed
unit on a time-and-materials basis related to the CRO Services
undertaken for each such unit. For any Work Order being paid on a
fixed-fee basis or on any payment schedule which is other than
either time-and-materials or a unit-based budget, all CRO Services
performed shall be converted to a time-and-materials basis in
accordance with CRL’s current rates and CRL shall be paid for
all CRO Services performed and Expenses incurred through the date
of suspension.

 

 

 

 

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6.2

CRL
may in its sole discretion suspend its performance of CRO Services
if an undisputed invoice is sixty (60) days or more overdue, and
CRL may refrain from resuming performance of CRO Services until all
overdue undisputed invoices have been paid in full. If CRL should
suspend the CRO Services pursuant to this Section 6.2, and in the
further event that the suspension shall remain in place for a
period of at least thirty (30) days, then at the end of such 30-day
period, CRL may invoice VistaGen and VistaGen shall pay for all CRO
Services which have been performed through the date of suspension
which have not been invoiced previously in the same manner as set
forth in Section 6.1.

 

6.3

Any
CRO Services performed related to a Work Order, during a period
when it is under suspension shall be invoiced on a
time-and-materials basis at CRLS’s then-current
rates.

 

6.4

Upon
suspension of CRO Services, CRL may reassign its personnel assigned
to the suspended Work Order unless a retainer fee in an amount to
be agreed upon by the Parties at such time is paid in advance of
each month during which VistaGen wishes to reserve the assigned
personnel. Payment of such retainer will ensure CRL will not
reassign the designated personnel such that they are unavailable to
provide the CRO Services upon resumption of CRO
Services.

 

6.5

If
any suspension initiated continues for a period of ninety (90)
days, then unless either a retainer is being paid pursuant to
Section 6.4 or the Parties agree to the contrary, at the end of the
90-day period the Work Order shall be deemed terminated either by
VistaGen without cause or by CRL with cause, as applicable, such
that the terms of Section 5.5 shall apply.

 

6.6

The
resumption of CRO Services after any suspension shall be subject to
any additional costs which may be incurred as a result of the Work
Order having been suspended and then restarted, including without
limitation the training of new personnel if the retainer has not
been paid for personnel to remain with the project.

7.

Confidential Information.

 

7.1

For
purposes of this Section, the Party disclosing Confidential
Information is known as “Disclosing Party” and the
Party receiving information is known as “Receiving
Party.” As applied to CRL, each of these terms shall include
CRL and any applicable Affiliates within the
definition.

 

7.2

"Confidential
Information" means: (i) all information furnished by the Disclosing
Party to the Receiving Party in tangible, visible, electronic or
verbal form or by observation or by any other means, including, but
not limited to, business plans, protocols, processes, samples,
formulae, chemical entities, compounds, mixtures, prospective and
current products, clinical data and analyses, test results,
toxicology and pharmacology information, study procedures and
manuals, pharmacy dispensing instructions, case report forms and
their content, statistical reports, project management and
staffing, manufacturing processes, nonpublished patent
applications, financial data, forecasts and projections,
proprietary software and database structures, research,
“know-how,” technology under development, marketing
information, agreements with or proprietary information of third
parties, licensors and licensees and strategic partners, regardless
of whether such disclosures are marked or otherwise designated as
“Confidential”; and (ii) the terms and conditions of
this Agreement, all proposals and requests for proposals (including
those submitted to the Receiving Party prior to the date of this
Agreement and marked as Confidential at the time of delivery), and
the existence of the discussions between the Parties to which this
Agreement pertains.

 

 

 

 

 

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7.3

No
information shall be within the above definition of Confidential
Information if
it:

 

(a) is
generally known to the public at the time the Disclosing Party
discloses it
to any Receiving Party;

 

(b) becomes
generally known to the public subsequent to the time of the
Disclosing Party's disclosure to any Receiving Party without any
fault or disclosure on the part of such Receiving
Party;

 

(c) was
known to any Receiving Party prior to the disclosure by the
Disclosing Party, free of any obligation of confidence, as
evidenced by such Receiving Party's written records;

 

(d) is
independently developed by such Receiving Party without reference
to or
reliance on the Confidential Information as evidenced by Receiving
Party’s written records;

 

(e) is,
to such Receiving Party’s knowledge, rightfully communicated
to it free
of any obligation of confidence by anyone who is not a Party to
this Agreement; or

 

(f) is
communicated by the Disclosing Party free of any obligation
of confidence
to anyone that is not a Party to this Agreement.

 

By way of example and not limitation, information is not generally
known to the public if it is not available without considerable
research or if it can be primarily located in cached memories of
materials otherwise deleted from internet sources. Notwithstanding
the foregoing, specific Confidential Information shall not be
deemed to be within any of the foregoing exclusions merely because
it is within the scope of more general information within one or
more of the exclusions. Further, any combination of Confidential
Information (whether or not combined with nonconfidential
information) shall not be deemed to be within the above exceptions
merely because one or more individual items of Confidential
Information are within the above exceptions. In furtherance but not
limitation of the preceding sentence, any combination of items of
Confidential Information shall not be deemed to fall within the
foregoing exclusions merely because any or all of the items are
published or otherwise in the rightful possession of the Receiving
Party unless the combination itself and the principle of its use
are published or otherwise in the rightful possession of the
Receiving Party.

 

7.4

Receiving
Party shall neither use nor reproduce Disclosing Party’s
Confidential Information except as necessary for: (a) negotiations,
discussions and consultations with the personnel or authorized
representatives of Disclosing Party; or (b) for the purpose of
performing its obligations under this Agreement. Upon completion of
the obligations under this Agreement that use the Confidential
Information, or upon termination of this Agreement, Receiving Party
shall, when requested by Disclosing Party in writing, promptly
return to Disclosing Party all of the Confidential Information
provided by Disclosing Party, except that Receiving Party may
retain one (1) copy for recordkeeping purposes and Receiving Party
shall not be required to remove or destroy any Confidential
Information contained on backup media as a result of systematic
backups of Receiving Party’s computer system, provided that
Receiving Party shall not access such backup media for the purpose
of recovering the Confidential Information.

 

 

 

 

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7.5

Receiving
Party shall not disclose, without the prior written consent of
Disclosing Party, any of Disclosing Party’s Confidential
Information to any third party other than Receiving Party’s,
and its Affiliates’, directors, officers, employees, agents
and consultants, hospital or institution authorities, Institutional
Review Board members, clinical investigators, and others who are
involved in fulfilling Receiving Party’s obligations under
this Agreement and who, in each case, (a) need to know such
information for the purposes of performing such obligations and (b)
are bound by obligations of confidentiality and non-use at least as
restrictive as those set forth herein. With respect to the
obligation in 7.5(b) it shall be deemed met as to disclosures by
CRL of VistaGen’s confidential information if VistaGen has in
place a nondisclosure agreement with the third party related to
VistaGen’s Confidential Information. Receiving Party shall
take commercially reasonable steps to prevent the disclosure or use
of any such Confidential Information by Receiving Party’s,
and its Affiliates’, directors, officers, employees, agents
or consultants except as provided in this Agreement.

 

7.6

If
any Disclosing Party’s Confidential Information is required
to be disclosed by Receiving Party to any government or regulatory
authority or court entitled by law to disclosure of the same,
Receiving Party shall not, unless required by law, order,
regulation or ruling, disclose Confidential Information until the
Disclosing Party has first (a) received prompt written notice of
such requirement to disclose and (b) had an adequate opportunity to
obtain a protective order or other reliable assurance that
confidential treatment will be accorded to the Confidential
Information required to be disclosed. The Receiving Party shall, at
the expense of the Disclosing Party, provide the Disclosing Party
with any reasonable assistance requested, and shall not oppose
reasonable actions by the Disclosing Party to assure confidential
treatment. If the Disclosing Party is unable to obtain such
protective order or other appropriate remedy, the Receiving Party
and its Representatives will furnish only that portion of the
Confidential Information which it is legally required to furnish.
Any disclosure of Confidential Information pursuant to this Section
7.6 shall not affect or lessen the Receiving Party’s
obligations hereunder.

 

7.7

For
purposes of this Agreement, the Parties hereby acknowledge and
agree that, subject to the exceptions set forth in Section 7.3,
this Agreement shall be considered VistaGen’s Confidential
Information; provided however, that either Party may disclose the
terms of this Agreement to advisors, investors and others on a
need-to-know basis under circumstances that reasonably ensure the
confidentiality, nondisclosure and nonuse thereof. Notwithstanding
the foregoing, VistaGen may disclose the existence of this
Agreement in its sole discretion.

 

7.8

Receiving
Party’s obligations under this Section 7 shall terminate with
respect to any Confidential Information of Disclosing Party five
(5) years after the date of disclosure.

 

8.

Protected Health
Information. The Parties
recognize that the Federal Health Insurance Portability and
Accountability Act of 1996 and implementing regulations
(“HIPAA”) require written confidentiality agreements to
protect the privacy and security of protected health information
(as defined under HIPAA) that may be acquired in the course of
performing this Agreement. The Parties agree to comply with HIPAA
and other applicable laws and governmental regulations governing
protected confidential health information. Under no circumstances
shall VistaGen deliver to CRL any social security or other
identification number issued to subjects/patients by any
governmental agency as part of the data delivered to CRL under any
Work Order.

 

 

 

 

 

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9.

Ownership.

 

9.1

VistaGen
shall own all right, title, and interest in and to all data,
information, improvements, discoveries, inventions, printed
materials, and other work product contained the Deliverable. To the
extent not covered by the preceding sentence, and except as limited
by Section 9.2, all copyrights, patents, trade secrets and other
intellectual property rights associated with any ideas, conepts,
techniques, inventions, processes or works of authorship included
in the Deliverable shall be treated in the same manner as the
deliverable and as specified in the previous sentence.. Upon
request of VistaGen and at VistaGen's expense, CRL shall take such
further actions, including execution and delivery of instruments of
conveyance necessary to obtain legal protection in the United
States and foreign countries for such Deliverable and for the
purpose of vesting title thereto in VistaGen. As used herein,
“Deliverable” shall mean reports, information or other
matters which are physically delivered (whether in hard copy or
electronically) to VistaGen in accordance with the terms of the
Work Order. To the extent the Work Order requires CRL to undertake
general consulting services pursuant to which CRL provides generic
explanations or information, only such part of any deliverable
which contains VistaGen-specific subject matter shall be deemed a
Deliverable subject to the terms of this Section 9.1

 

9.2

Notwithstanding
the foregoing Section 9.1, VistaGen acknowledges that within the
scope of the business practices of CRL and its Affiliates, they
possess certain inventions, processes, know-how, trade secrets,
improvements, other intellectual property and business assets,
including forms, templates, analytical methods, protocols,
procedures and techniques, computer technical expertise and
software, independently developed or otherwise owned by CRL and its
Affiliates and not specifically related to the Deliverables. In
addition, during the course of performing or incidental to the CRO
Services, CRL or its Affiliates may develop forms, templates,
analytical methods, protocols, procedures and techniques,
functions, computer code, database structures and other property
that are not specific to the general functionality of the
Deliverables, not specific to any Product unique to VistaGen, and
which does not in its generic form rely on or otherwise incorporate
any Confidential Information of VistaGen (collectively, the
“Cato Property”). VistaGen and CRL agree that any Cato
Property used, improved or modified by CRL or its Affiliates under
or during the term of this Agreement shall be deemed Cato Property
and owned solely by CRL or its Affiliates. If any Cato Property is
incorporated into the Deliverables, then CRL hereby grants to
VistaGen a fully paid-up, non-exclusive, perpetual worldwide
license to use such Cato Property (without representation or
warranty), to the extent reasonably necessary to use such
Deliverables and to transfer rights to the VistaGen products or
programs to which this Agreement relates.

 

9.3

CRL
and its Affiliates shall be free to use and employ the general
skills, knowhow, and expertise of their employees, and to use,
disclose, and employ any generalized ideas, concepts, know-how,
methods, techniques, or skills gained or learned by their employees
and consultants during the course of any assignment, so long as
they acquire and apply such information without disclosure of any
Confidential Information of VistaGen and without any unauthorized
use or disclosure of any Deliverable.

 

 

 

 

 

-10-

 

 

 

10.

Representations and Warranties.

 

10.1

CRL
represents and warrants that CRL has the experience, capability,
personnel and resources necessary to perform CRO Services under
this Agreement and each Work Order in a commercially reasonable
manner.

 

10.2

VistaGen
represents and warrants that it has the ability to comply with and
perform all financial obligations under this Agreement. VistaGen
further represents and warrants that it owns or otherwise has all
necessary rights in and to the Product and all intellectual
property rights therein (including without limitation the patent
rights in all Products) so as to permit use of the Product and such
intellectual property by CRL as contemplated in each Work Order; no
third party has any right to prevent or to claim a payment is due
from CRL as a result of its use of any Product or of the
intellectual property rights therein as contemplated in any Work
Order.

 

10.3

Each
Party represents and warrants that (a) it has the corporate power
and authority to enter into and perform its obligations under this
Agreement and any Work Order; and (b) entering into and performing
this Agreement and any Work Order will not conflict with or result
in a violation of any of the terms or provisions, or constitute a
default under any of its organizational documents, any mortgage,
indenture, lease, contract or other agreement or instrument binding
upon it or by which any of its properties are bound, or any permit,
concession, franchise, license, judgment, order, decree, statute,
law, ordinance, rule or regulation applicable to it or its
properties.

 

10.4

Except
as set forth in this Section 10, CRL makes no warranty, either
express or implied, including without limitation the warranties of
merchantability, fitness for a particular purpose, title and
non-infringement as to any matter, and further including but not
limited to the CRO Services, results of CRO Services, any
Deliverables or any other matter or information produced or
provided under this Agreement. Without limiting the foregoing, CRL
does not warrant, guarantee, or make any warranty regarding the
use, or the results of the use, of the Deliverable, reports,
analyses, documents, memoranda or any other matter or information
produced or provided under this Agreement.

 

11.

CRL Personnel.

  

11.1

CRL
shall be responsible for all aspects of the labor relations of the
personnel undertaking the CRO Services including, but not limited
to, wages, benefits, discipline, hiring, firing, promotions, pay
raises, overtime, and job assignments. VistaGen shall have no power
or authority in these areas. CRL shall ensure the payment of all
contributions and taxes imposed by any federal or state
governmental authority with respect to or measured by wages,
salaries, or other compensation paid to persons employed to
undertake the CRO Services.

 

 

 

 

-11-

 

 

 

11.2

VistaGen
understands that the performance of CRO Services requires special
skills, training and experience. VistaGen further understands that
CRL and its Affiliates have expended considerable sums to train
their personnel to perform the CRO Services requested by VistaGen
from time to time under this Agreement, and CRL will give VistaGen
access to experienced and highly skilled practitioners. When CRL or
its Affiliates lose personnel, CRL or its applicable Affiliate
incurs significant expenses in hiring and training his or her
replacement. Accordingly, during the term of this Agreement and for
a period of one (1) year after the termination or expiration of the
last Work Order to terminate or expire under this Agreement,
VistaGen agrees that it will not, without CRL’s prior written
permission, solicit for employment (directly or indirectly) or hire
as an employee or independent contractor any employee or
independent contractor of CRL or its Affiliates who has
participated in the performance of CRO Services under this
Agreement. VistaGen acknowledges that any breach by VistaGen of
this Section 11.2 shall cause substantial damages to CRL which are
difficult to calculate including, but not limited to, costs of
hiring and training replacement personnel, lost revenue and damage
to CRL’s relationships with its other customers.
Correspondingly, if VistaGen breaches this Section 11.2, VistaGen
agrees that it shall pay CRL liquidated damages in an amount equal
to the first-year annual guaranteed compensation (including base
salary and any guaranteed bonus) of the hired person.
...

 

12.

Indemnification.

 

12.1

VistaGen
shall indemnify, defend and hold harmless each CRL Indemnified
Party from and against all Losses resulting from, related to or (as
appropriate) alleging any CRL Indemnified Conditions. The foregoing
indemnification obligations of VistaGen under this Section 12.1
shall not include any Losses incurred by CRL when, and to the
extent that, such Losses result from or are related to (a) the
negligence, intentional misconduct or intentional omission of the
CRL Indemnified Party, (b) the breach of this Agreement by CRL, an
Affiliate of CRL or any other person for whose actions CRL is
liable under this Agreement or applicable law, or (c) the violation
by CRL, its directors, officers, employees or agents of any
applicable law, regulation or other government requirement where
such violation was caused by the conduct of the relevant CRL
Indemnified Party and where CRL is seeking indemnification due to
such breach.

 

12.2

CRL
shall indemnify, defend and hold harmless each VistaGen Indemnified
Party from and against all Losses resulting from, related to or (as
appropriate) alleging any VistaGen Indemnified Conditions. The
foregoing indemnification obligations of CRL under this Section
12.2 shall not include any losses incurred by VistaGen when, and to
the extent that, such Losses result or are related to (a) the
negligence, intentional misconduct or intentional omission of the
VistaGen Indemnified Party; (b) the breach of this Agreement by
VistaGen, an affiliate of VistaGen, or any other person for whose
actions VistaGen is liable under this Agreement or applicable law;
or (c) the violation by VistaGen, its directors, officers,
employees or agents, of any applicable law, regulation or other
governmental requirement. Notwithstanding the foregoing, CRL shall
not be liable for, and this Section 12.2 does not require CRL to
provide indemnification with respect to, the actions or omissions
of any third party which CRL hires (excluding Affiliates of CRL) at
VistaGen’s request to provide services
hereunder..

 

 

 

 

-12-

 

 

 

12.3

If
an Indemnified Party receives notice of any claims for which the
Indemnified Party wishes to seek indemnity under this Agreement,
then the Indemnified Party shall promptly provide prompt written
notice of the claim no later than thirty (30) calendar days
following its notice of the claim to the Party required to provide
indemnification by Section 12.1 or 12.2. The failure of an
Indemnified Party to promptly provide such notice will not relieve
the indemnifying Party of any indemnification responsibility under
this Section 12, except to the extent, if any, that such failure
materially prejudices the ability of the Indemnifying Party to
defend such claims. The indemnifying Party shall have the right to
control the defense or settlement of the claims with counsel of its
own choosing provided that such counsel is reasonably acceptable to
the Indemnified Party and provided further that the Indemnified
Party will be entitled, at the Indemnified Party’s expense,
to participate with its own counsel in such defense and settlement.
The Indemnified Party shall at all times cooperate in the
investigation and defense of such claims and promptly deliver to
the indemnifying Party (or its counsel) such information related to
the basis for the claims as the indemnifying Party (or its counsel)
may reasonably request. If the indemnifying Party declines to
assume defense of any claim, and it is later determined by a court
of competent jurisdiction that such claim was eligible for
indemnification under Section 12.1 or 12.2, as applicable, then
within thirty (30) calendar days following such determination, the
Indemnifying Party shall reimburse the Indemnified Party in full
for all judgments, costs and expenses (including reasonable
attorneys’ fees) incurred in connection with such claim. The
indemnifying Party shall not settle any claim without the prior
written consent of the Indemnified Party if such settlement: (a)
materially diminishes any of the Indemnified Party’s rights
under this Agreement and/or the Work Order or seeks to impose
additional obligations on the Indemnified Party; or (b) arises out
of or is a part of any criminal action, suit or proceeding or
contains a stipulation or admission or acknowledgement of any
liability or wrongdoing (whether in contract, tort or otherwise) on
the part of the Indemnified Party.

 

12.4

Definitions.
The following definitions apply in this Section 12:

 

(a)

“CRL
Indemnified Party” means CRL and its Affiliates and the
directors, officers, employees, consultants and agents of CRL
and/or its Affiliates.

 

(b)

“VistaGen
Indemnified Party” means VistaGen and its Affiliates and the
directors, officers, employees, consultants and agents of VistaGen
and/or its Affiliates.

 

(c)

“Indemnified
Party” means either a CRL Indemnified Party or an
VistaGen
Indemnified Party.

  

(d)

“Losses”
mean all liability, loss, costs, claims, damages, expenses,
judgments, awards, and settlements, including (without limitation)
actual attorneys’ fees and expenses, whether arising in tort
or in contract, in law or in equity. arising from a claim brought
by a third party, in response to any legal proceeding brought by a
third party or occurring due to any contractual obligation to
indemnify, defend and/or hold harmless any third
party.

 

 

 

 

 

-13-

 

 

 

(e)

“CRL
Indemnified Conditions” means:

 

(i)

the
CRO Services;

 

(ii)

the
use of Deliverables;

 

(iii)

any
harm or bodily injury caused by any Product;

 

(iv)

the
infringement of or use of any intellectual property right or
proprietary right in relation to VistaGen’s Products,
programs, procedures, materials, data, or other information used
by, or on behalf of, or furnished by or on behalf of, VistaGen in
connection with this Agreement or the provision of CRO Services
under this Agreement;

 

(v)

the
material breach of this Agreement by VistaGen or by any other
person for whose actions VistaGen is liable under this Agreement or
applicable law;

 

(vi)

the
negligence, intentional misconduct or intentional omission of
VistaGen or of any employee, contractor, agent or representative of
VistaGen; or

 

(vii)

any
request for deposition, documents or other information legally
compelled including, without limitation, by subpoena or by
agreement made in lieu of subpoena, in connection with
VistaGen’s litigation, arbitration or other proceeding with
any third party where CRL and/or any of its Affiliates are not also
a party or in any investigation of VistaGen by any governmental
authority.

 

            

            

(f)
“VistaGen Indemnified Conditions” means:

 

(i)

the
negligence, intentional misconduct or intentional omission of CRL
or any employee, contractor, agent or representative of
CRL;

 

(ii)

the
material breach of this Agreement by CRL or any other person for
whose actions CRL is liable under applicable law or this
Agreement;

 

(iii)

the
violation by CRL, its directors, officers, employees or agents, of
applicable law, regulation or other governmental
requirement;

 

13.

Insurance.

 

13.1

VistaGen
shall maintain in full force and effect customary insurance
coverage for all VistaGen Products, clinical trials or other
projects related to the CRO Services, including, without
limitation, products liability, general liability, and related
insurance coverage with policy limits in an amount VistaGen’s
senior management reasonably determines to be sufficient to support
VistaGen’s indemnification obligations hereunder, but as of
such date as VistaGen commences a clinical trial for which CRL or
its Affiliates provide CRO Services, then in no event less than
$5,000,000 per occurrence as it relates to clinical trials. Upon
completing or otherwise terminating each clinical trial for which
CRL provides CRO Services, VistaGen shall purchase and maintain a
tail policy to cover claims first made and/or reported after
completion of such clinical trial.

 

 

 

 

-14-

 

 

 

13.2

VistaGen’s
insurance policy(ies) covering any clinical trial shall name CRL
and its respective officers, directors and employees as additional
named insureds with a broad form additional insured endorsement
(acceptable in form and content to CRL) and shall indicate that the
policy will not be canceled or changed until thirty (30) days after
written notice of such cancellation or change is delivered to CRL.
At CRL’s request, VistaGen shall provide CRL with an
additional insured certificate and a copy of the additional insured
endorsement from VistaGen’s insurance carrier.

 

13.3

CRL
shall maintain in full force and effect, at no cost to VistaGen,
customary insurance coverage for the CRO Services to be undertaken
under each Work Order with policy limits in an amount CRL’s
senior management reasonably determines to be commercially
reasonable under the circumstances.

 

14.

Limitation of Liability.

 

14.1

VistaGen
agrees that, regardless of the form of any claim, VistaGen’s
sole remedy and CRL’s sole obligation with respect to any
claims made related to or arising out of this Agreement shall be
governed by this Section.

 

14.2

VistaGen’s
remedies for defective performance by CRL under this Agreement
shall be limited to, at CRL’s option, either: (a) correction
of the non-conforming CRO Services, or (b) reimbursements of
payments (excluding payments for Expenses) made by VistaGen to CRL
for such non-conforming CRO Services under the applicable Work
Order during the six (6) month period immediately preceding the
event for which the claim is made.

 

14.3

CRL’s
obligations for any reason other than as set forth in Section 14.2
shall not exceed the aggregate compensation paid to CRL for CRO
Services actually performed during the rolling twelve (12) month
period preceding the date on which notice of the claim is given
under the Work Order to which the claim pertains; provided however,
with respect to delivery of any notice of claim during the initial
twelve (12) months of the applicable Work Order, such limitation
shall be equal to the actual aggregate compensation paid to CRL
during the first six months of such Work Order; and provided,
further, with respect to delivery of any notice of claim following
termination or expiration of this Agreement, such limitation shall
be equal to the aggregate compensation paid to CRL during the final
twelve (12) months of the applicable Work Order.

 

14.4

It
is expressly agreed that in no event shall CRL, its Affiliates or
anyone else who has been involved in the performance of this
Agreement on behalf of CRL be liable for any indirect,
consequential, incidental, special, punitive, or exemplary damages
arising from any legal theory, even if such person had been
apprised of the likelihood of such damages occurring. VistaGen
agrees that, notwithstanding the applicable statute of limitations,
it may not bring any claim against CRL more than one (1) year after
the cause of action arose.

 

 

 

 

 

-15-

 

 

 

15.

Investigator and Other Third-Party Payments.

 

15.1

CRL
shall, at VistaGen’s request in a Work Order, disburse
payments to investigators, monitors, laboratories or other third
parties contracted with VistaGen to provide services with respect
to a clinical study for which CRL is providing CRO Services to
VistaGen (each, a “Third-Party Contractor”). CRL will
disburse all such payments (each, a “Third-Party Contractor
Fee”) in accordance with the provisions of the agreement
between VistaGen and the Third-Party Contractor (each, a
“Third-Party Contractor Agreement”), a copy of which
shall be provided to CRL prior to any payment being made. CRL will
not unreasonably withhold any Third-Party Contractor Fee and will
not impose additional restrictions on the terms of payment for the
Third-Party Contractor Fee set forth in the Third-Party Contractor
Agreement.

 

15.2

VistaGen
shall provide CRL with the funds to pay each Third-Party Contractor
Fee, plus any related administrative fee, prior to the date on
which CRL is scheduled to disburse such Third-Party Contractor Fee.
To the extent payments to any Third-Party Contractors are to be
made in a currency other than U.S. dollars, then contrary to the
terms of Section 4.3 to make payment in U.S. dollars, funds for
each such payment shall be made by VistaGen in the currency in
which the Third-Party Contractor Fee is to be paid. If VistaGen
does not provide the funds to CRL, then CRL will not disburse such
Third-Party Contractor Fee until it receives the funds, including
any administrative fee, from VistaGen. In such event, VistaGen
shall be deemed to have released CRL from all legal liability, and
to have covenanted to indemnify and not to sue CRL on any claims
related to failure to disburse or otherwise pay the Third-Party
Contractor Fee. VistaGen agrees that CRL shall not have any
liability to VistaGen with respect to payments made to any
Third-Party Contractor in accordance with the terms of the
applicable Third-Party Contractor Agreement, even if VistaGen would
prefer such payment not be made unless VistaGen shall have notified
CRL, which notification may be made by any reasonable means (which
may include email, depending on the circumstances), prior to the
time the payment is due not to make the payment. If VistaGen
notifies CRL not to make any payment, VistaGen agrees to indemnify
CRL with respect to any claims made against it by the Third-Party
Contractor related to failure to disburse or otherwise pay the
Third-Party Contractor Fee withheld in accordance with
VistaGen’s instructions.

 

15.3

If
VistaGen provides CRL with funds in excess of the total Third-Party
Contractor Fees disbursed by CRL (plus any administrative fee for
Third-Party Contractor Fees actually paid), then CRL shall prepare
and send a reconciliation of such funds to VistaGen within ninety
(90) days after the early termination or expiration of the Work
Order under which such Fees were being disbursed. Any excess funds
shall first be applied to undisputed amounts otherwise due to CRL
hereunder, and then any remainder shall be refunded to
VistaGen.

 

 

 

 

 

-16-

 

 

 

16.

Transfer of Responsibilities and Obligations.

 

16.1

If
VistaGen, pursuant to a Work Order, requests that CRL enter into
agreements with investigators, monitors, laboratories, storage
facilities, clinical material manufacturers or shippers, or other
third parties to provide services with respect to a clinical study
for which CRL is providing CRO Services to VistaGen (each a
“Third-Party Agreement”), then subject to CRL
undertaking its obligations under each Third-Party Agreement
(except as with respect to payment which is governed by Section
16.2), VistaGen will assume all obligations and liabilities under
such Third-Party Agreement, including but not limited to all
regulatory and legal obligations, and indemnify CRL for any claims
made against CRL for any liability incurred by it as a result of
the execution and delivery by CRL of such Third-Party Agreement(s).
Notwithstanding the foregoing, the Parties shall establish a
process for review of Third-Party Agreements before execution,
which process shall generally include an agreement on the base
form, information provided by VistaGen on parameters for changes,
and consultation with VistaGen on significant issues outside the
parameters. If a Work Order terminates (for any reason) before
completion of the CRO Services specified therein and pursuant to
that Work Order, CRL has entered into any Third-Party Agreements,
CRL shall be free to terminate such Third-Party Agreements and
VistaGen shall pay all termination fees or other liabilities owed
by CRL or its Affiliates due to such termination.

 

16.2

VistaGen
shall provide CRL with the funds to pay each Third-Party Agreement
(the “Third-Party Fees”), plus any administrative fee,
before the date on which CRL is scheduled to disburse each such
Third-Party Fee. To the extent payments to Third Parties are to be
made in a currency other than U.S. dollars, then contrary to the
terms of Section 4.3, funds for each such payment shall be made by
VistaGen in the currency in which the Third-Party Fee is to be
paid. If VistaGen does not provide the funds to CRL before the
scheduled payment date, then CRL will not disburse such Third-Party
Fee until it receives the funds (including any administrative fee)
from VistaGen. CRL shall have no liability to VistaGen with respect
to payments made to any Third Party in accordance with the terms of
a Third-Party Agreement, even if VistaGen would prefer such payment
not be made unless VistaGen instructs CRL not to make the payment
before CRL does so. If VistaGen fails to provide the required funds
on a timely basis or notifies CRL to withhold or otherwise not pay
any Third-Party Fees required to be paid under an applicable
Third-Party Agreement, then VistaGen agrees to indemnify CRL with
respect to any claims made against CRL by the Third Party for
failure to make (or delay in making) the payment of the Third-Party
Fees (including, but not limited to, charges for interest and late
payment fees). If VistaGen provides CRL with funds in excess of the
total Third-Party Fees disbursed by CRL (plus the administrative
fee), then CRL shall prepare and send a reconciliation of such
funds to VistaGen within ninety (90) days after the early
termination or expiration of the Work Order under which such
Third-Party Fees were being disbursed. Any excess Third-Party Fees
shall first be applied to undisputed amounts otherwise due to CRL
hereunder, and then any remainder shall be refunded to
VistaGen.

 

16.3

Transfer
of sponsor obligations with respect to any clinical trial may only
be made pursuant to a Work Order, a signed Transfer of Sponsor
Obligation form, and otherwise in accordance with 21 CFR 312.52 and
other applicable laws and regulations.

 

 

 

 

 

-17-

 

 

 

17.

Audits, Inspections and Site
Visits.

 

17.1

VistaGen
and/or VistaGen’s representative may, during normal business
hours and upon no less than two (2) weeks’ prior notice, meet
with CRL or its applicable Affiliate(s) and their respective
employees, consultants, and/or subcontractors engaged in the
performance of CRO Services at CRL or at the location(s) of the
facilities used to undertake the CRO Services to: (i) examine and
inspect the facilities used for the performance of CRO Services,
(ii) observe the progress of activities relating to the CRO
Services; (iii) inspect and copy or have copied records, documents,
information, data, and materials specifically relating to the CRO
Services, and (iv) inspect and copy or have copied financial
reports and other documents accounting for the fees, costs and
expenses of the CRO Services.

 

17.2

CRL
will, during regular business hours and on no less than two (2)
weeks’ notice, permit a regulatory auditor to have access to
CRL’s records pertaining to the CRO Services provided
pursuant to this Agreement for the purpose of auditing and
verifying such CRO Services.

 

17.3

CRL
will, during regular business hours and on no less than two (2)
weeks’ notice, permit a financial auditor to have access to
CRL’s records pertaining to the CRO Services provided
pursuant to this Agreement for the purpose of auditing and
verifying the billing for such CRO Services.

 

17.4

At
VistaGen’s reasonable request, CRL shall cooperate with any
regulatory authorities and allow them to review and copy applicable
records and data related to the CRO Services. If a request is made
directly to CRL (or its applicable Affiliate(s)) by any regulatory
authority to review records and data, or to contact, visit, or
inspect CRL’s (or its applicable Affiliate’s or
investigator’s) records and data, relating to any CRO
Services or CRL’s (or its applicable Affiliate’s or
investigator’s) performance of CRO Services, then CRL shall
notify VistaGen as soon as practicable (unless prohibited by law)
after such regulatory authority issues or gives to CRL (or any such
of its applicable Affiliate(s) or investigator) any notice of
intent to inspect, notice of inspection, notice of inspectional
observations, warning letter, or other written communication
concerning any CRO Services, and CRL shall provide VistaGen a copy
thereof. To the extent permitted by law, prior to any submission to
a regulatory authority of any response that may be required as a
result of the inspection or visit, CRL (its applicable Affiliate(s)
or investigator) shall provide VistaGen with the opportunity to
review and comment on the proposed response.

 

17.5

All
persons sent by VistaGen to undertake such visits, inspections or
audits pursuant to Sections 17.1-17.3 shall be qualified by
education, training, and experience, and shall be reasonably
acceptable to CRL. The number, extent and frequency of such visits,
inspections or audits shall be reasonable under the circumstances
and normally shall not exceed one in every twelve (12) month
rolling period. Unless such person is an employee of VistaGen, he
or she shall report to VistaGen only those facts and conclusions
determined as a result of the visit which are directly related to
VistaGen’s interests. All information obtained from an audit
shall be Confidential Information except as otherwise set forth in
Section 7.3, above. Unless the visits, inspections and/or audits
set forth in Sections 17.1-17.4 are specifically included in a Work
Order, VistaGen shall, in addition to any other payment obligations
under this Agreement, pay CRL, on a time-and-materials basis, at
its current rates for the CRL or Affiliate personnel assigned to
supervise or otherwise participate in or assist administratively
with such audit, inspection or visit, including without limitation
for any CRL or Affiliate personnel required to participate in it or
meet with the regulatory inspectors.

 

 

 

 

 

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18.

Force Majeure; Other
Delays.

 

18.1

If
either Party is delayed in, hindered in, or prevented from the
performance of any act required under this Agreement by reason of
strike, lockout, labor problems, restrictions of government,
judicial orders or decrees, riots, insurrection, terrorism, war,
acts of God, inclement weather, or other causes that are beyond the
reasonable control of such Party, then performance of such act
shall be excused until the cause is remedied. The delayed Party
shall use commercially reasonable efforts to resume performance as
soon as possible.

 

Notwithstanding the foregoing, this Section 18.1 shall not apply to
or excuse any failure to make payments when due.

 

18.2

CRL
will not be liable to VistaGen nor be deemed to have breached this
Agreement for errors, delays or other consequences arising from the
failure of VistaGen or any third party not under CRL’s direct
control to provide documents, materials or information in a timely
manner or otherwise cooperate in order for CRL to perform its
obligations, and any such failure by VistaGen or any third party
not under CRL’s direct control shall automatically extend any
timelines affected by such failure by at least the period of the
delay (and such longer period as it may take as a result of the
need to suspend and then wind up again), unless VistaGen agrees in
writing to pay any additional costs that would be required to meet
the original timeline.

 

19.

Independent
Contractor. CRL shall perform
CRO Services as an independent contractor. Neither Party has
authority to make any statement, representation, or commitment of
any kind nor to take any action binding on the other Party without
the other Party’s prior written consent.

 

20.

Use of Names. The Parties agree that they may use each
other’s name as a reference for prospective clients or in
literature relating to their capabilities and strategic
relationships, provided that such use does not violate Section 7
above.

 

21.

Notification. Any notices given hereunder shall be in writing
and shall be deemed to have been given on the earlier of personal
receipt by an authorized representative of the Party, or receipt at
the Party’s notice address. Notice may be given by the
following means: registered mail/return receipt requested,
overnight courier, personal delivery, or, where specified in this
Agreement, by email. All notices shall be sent to a Party at its
address set forth on the signature page of this Agreement, or to
such other address as is given by notice to the other Party.
Notices are deemed given on receipt or attempted delivery (if
receipt is refused).

 

22.

Waiver. No waiver of any right or remedy with respect to
any occurrence or event shall be valid unless it is in writing and
executed by the waiving Party. No such valid waiver shall be deemed
a waiver of such right or remedy with respect to such occurrence or
event on a continuing basis or in the future unless the waiver
states that it is intended to apply continuously or to future
events. A waiver shall not excuse use a subsequent breach of the
same term, unless the waiver so states.

 

 

 

 

-19-

 

 

 

23.

Severability. If any provisions of this Agreement are
determined to be invalid or unenforceable, those provisions shall
be reformed to the extent necessary to comply with law and the
Parties’ intent, or struck if necessary, and the validity and
effect of the other provisions of this Agreement shall not be
affected.

 

24.

Contract Interpretation and
Dispute Resolution.

 

24.1

The
official language of this Agreement and any interpretation of it is
American English. All contract interpretations, notices and dispute
resolutions shall be in English. Any attachments or amendments to
this Agreement shall be in English. Translation of any of these
documents shall not be construed as official or original versions
of the documents.

 

24.2

This
Agreement has been prepared following arm’s-length
negotiations in which each Party had the opportunity to consult
with legal counsel regarding the provisions hereof. Every covenant,
term and provision of this Agreement shall be construed according
to its fair meaning and not strictly for or against any Party or
Parties.

 

24.3

This
Agreement shall be governed by, construed and interpreted in
accordance with the laws of the United States and the State of New
York, without regards to its conflict of law
principles.

 

24.4

Any
controversy, claim or dispute arising out of, in connection with or
relating to this Agreement shall be first submitted to mediation,
which mediation shall take place in San Diego, Calfornia, unless
another location shall be agreed upon by the Parties. If mediation
is not successful, then the dispute shall be resolved solely by
binding arbitration, in accordance with Exhibit A and the
Commercial Arbitration Rules of the American Arbitration
Association (“AAA”) in effect as of the day the
arbitration demand is made. If the AAA rules conflict with Exhibit
A, Exhibit A shall prevail.

  

24.5

Notwithstanding
Section 24.4, (a) with respect to any uncollected invoice, if
CRL asks
VistaGen if VistaGen disputes that payment is due and either
VistaGen does not reply within one (1) month or VistaGen replies
that there is no dispute, then CRL may bring a collection suit in a
court resident in Durham County, North Carolina and VistaGen
consents to the personal jurisdiction of such courts in such
matter; and (b) if damages for a breach are not likely to be an
adequate remedy, then either Party may bring an injunction
proceeding before any court with jurisdiction.

 

25.

Survival. The representations and warranties of the
Parties in Section 10 shall survive the events to which they relate
and survive the expiration or earlier termination of this Agreement
and the rights and obligations of the Parties set forth in Sections
3.2, 4, 5, 7 - 17, 20, 24 and 25 shall survive expiration or
earlier termination of this Agreement.

 

26.

Assignment. This Agreement may not be assigned by either Party
without the prior written consent of the other Party, which shall
not be unreasonably withheld; provided however, that either Party
may assign this Agreement without prior written consent of the
other Party in connection with a merger or the sale of all or
substantially all of the assigning Party’s assets or equity
on the condition that such assignment shall be solely to the
acquirer or purchaser of the assigning Party and such acquirer or
purchaser must assume the assigning Party’s obligations under
this Agreement.

 

 

 

 

-20-

 

 

 

27.

Freedom to
Contract. Except with respect
to CRO Services for which VistaGen specifically hires CRL to
perform under this Agreement, (a) VistaGen is not required to use
CRL for any specific work; (b) VistaGen is free to retain others to
perform the same or similar CRO Services as offered by CRL; (c) CRL
is not required to provide any CRO Services to VistaGen; and (d)
CRL is free to provide CRO Services to other clients that are
similar to CRO Services provided to VistaGen.

 

28.

Entire
Agreement. Exhibit A to this
Agreement and Work Orders are incorporated into and made a part of
this Agreement. This Agreement, including the incorporated Exhibit
A and Work Orders, constitutes the entire agreement between the
Parties relating to the subject matter hereof and supersedes all
prior agreements, whether written or oral, relating to the subject
matter hereof; provided however, that all prior confidentiality,
nonuse and nondisclosure agreements shall remain in effect as to
all matters not specifically covered by this Agreement. Except as
otherwise authorized herein, changes, modifications, and amendments
shall be valid only if made in writing and signed by both Parties.
To be effective, any agreement between the Parties purporting to
amend a term of this Agreement, including without limitation any
Work Order, must specifically identify that term’s Section
number and state the Parties’ specific intent to amend that
term.

 

29.

Signatures. This Agreement and any amendment or Work Order
issued under it may be executed in one or more counterparts, each
of which shall be deemed to be an original but all of which
together shall constitute one and the same instrument. Facsimile
signatures and signatures transmitted by email after having been
scanned shall be accepted as originals for the purposes of this
Agreement and any Work Orders issued hereunder.

 

 

 

 

-21-

 

 

The Parties have executed this Agreement as of the date first
written above.

 

 

	
Cato Research Ltd.

	
VistaGen Therapeutics,
Inc.

	
 

	
 

	
By: Jo Cato

The signer certifies that he/she has the
authority to execute this Master Services Agreementon
behalf of Cato Research
Ltd.

	
By: Shawn K.
Singh

 

The signer certifies that he/she has the
authority to execute this Master Services Agreement
behalf of VistaGen Therapeutics,
Inc.

	
 

Name:  Jo
Cato  

	
 

Name: Shawn J. Singh
 

	
Title: COO  

	
Title: Chief
Executive Officer

 

                                                             
           

 

                              
           

 

 

 

-22-

 

 

 

EXHIBIT A

ARBITRATION PROCEDURES

 

The following rules shall apply to any arbitration of the parties
under Section 24:

 

 

1. Location and
Language. The location of the
arbitration shall be in San Mateo, California, unless the Parties should agree to a different
location. The arbitration shall be conducted in American English
and any findings and/or decisions shall be rendered in American
English.

 

2. Number and Selection of
Arbitrator. The arbitration
shall be conducted by one arbitrator who is independent and
disinterested with respect to the Parties, this Agreement, and the
outcome of the arbitration (a “neutral arbitrator”). If
the Parties cannot agree on a neutral arbitrator, then each Party
shall select an arbitrator it believes to be neutral, who together
shall select a third neutral arbitrator to conduct the arbitration.
The arbitrator will be selected with consideration given to his or
her experience with disputes of the type being submitted (e.g., the
nature of the claim and the technology involved). It is the intent
of the Parties that the final arbitrator be selected within thirty
(30) days after the arbitration demand is first
made.

 

3. Case
Management. 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 arbitrator is instructed and directed to assume
case management initiative and control over the arbitration process
(including 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 to
obtain a just resolution of the dispute.

 

4. Remedies. The arbitrator shall follow and apply the
applicable law. The arbitrator shall grant such legal or equitable
remedies and relief in compliance with applicable law that the
arbitrator deems just and equitable, but only to the extent that
such remedies or relief could be granted by a state or federal
court and as otherwise limited by the terms in this Agreement. No
punitive damages may be awarded by the arbitrator. The arbitrator
may not award punitive damages and no court action may be
maintained seeking punitive damages.

 

5. Expenses. The expenses of the arbitration, including the
arbitrator’s fees, expert witness fees, and attorney’s
fees, may be awarded to the prevailing Party, in the discretion of
the arbitrator, or may be apportioned between the Parties in any
manner deemed appropriate by the arbitrator. Unless and until the
arbitrator decides that one Party is to pay for all (or a share) of
such expenses, both Parties shall share equally in the payment of
the arbitrator’s fees as and when billed by the
arbitrator.

 

6. Confidentiality.
The Parties shall keep confidential the fact of the arbitration,
the dispute being arbitrated, and the decision of the arbitrator.
Notwithstanding the foregoing, (a) 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, and others who
may be directly affected; (b) if a Party has stock that is publicly
traded, the Party may make such disclosures as are required by
applicable securities laws or listing rules; and (c) if a Party is
expressly asked by a Third Party about the dispute or the
arbitration, the Party may disclose and acknowledge in general and
limited terms that there is a dispute with the other Party which is
being (or has been) arbitrated.

 

 

A-1FORM OF
BRIDGE DEBENTURE AGREEMENT

 

This
Bridge Debenture Agreement (this “Agreement”), dated as of June 24, 2019, is made by and among Rennova Health,
Inc. (the “Company”) and each of the purchasers signatory hereto (the “Purchasers”). Reference
is made to that certain Securities Purchase Agreement, dated as of August 31, 2017 (the “Purchase Agreement”),
as amended, by and among the Company and each purchaser identified on the signature pages thereto. Capitalized terms used and
not otherwise defined herein that are defined in the Purchase Agreement shall have the meanings given such terms in the Purchase
Agreement.

 

For
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:

 

1.
Issuance of Bridge Debenture. The Company hereby agrees to issue, jointly and severally with Christopher Diamantis, to
the Purchasers, and the Purchasers hereby agree to purchase debentures of the Company, the aggregate principal amount of $1,020,000
of debentures, which debenture shall be in the form of the debenture attached hereto as Exhibit A (the “Bridge
Debentures”). The total aggregate purchase price to the Purchasers for the purchase of the Bridge Debentures is $1,020,000.
The Company shall promptly deliver to each Purchaser the applicable Bridge Debentures.

 

2.
Security Interest and Mortgage. Company hereby acknowledges and agrees that (a) the security interests granted to the holders
of the outstanding convertible debentures (“Existing Debentures”) pursuant to the Security Agreement, dated
May 20, 2017 applies to and covers the obligations of the Company to the Purchasers evidenced by the Bridge Debentures, (b) upon
the filing of an amendment to the Existing Mortgage (as defined in the Purchase Agreement), the liens granted to the Purchasers
pursuant to the Existing Mortgage applies to and covers the obligations of the Company to the Purchasers evidenced by the Bridge
Debentures and (c) the Bridge Debentures rank pari passu to the Existing Debentures.

 

3.
Subsidiary Guarantee. The Bridge Debenture constitutes an “Obligation” under the Subsidiary Guarantee (as defined
in the Purchase Agreement) as if the Bridge Debentures were Existing Debentures issued pursuant to the Purchase Agreement.

 

4.
Subordination Agreement. The Company shall have received confirmations and acknowledgments from the signatories thereto
that the Bridge Debentures are subject to the subordination agreements required pursuant to the Purchase Agreement.

 

5.
Exchange Right. Reference is made to that certain Exchange Agreement, dated October 30, 2017, by and between the Company
and the Purchaser (“Exchange Agreement”) and the Series I-2 Convertible Preferred Stock (“Preferred
Stock”) issuable upon exchange of the Existing Securities (as defined thereunder). Each Purchaser shall have the right,
in its sole discretion, to exchange, from time to time and all or in part, any principal amount of the Bridge Debentures pursuant
to the Exchange Agreement as if such Bridge Debentures were Existing Debentures. The issuance of Exchange Securities in exchange
for Bridge Debentures shall be on the same terms and conditions as the exchange for Existing Securities. The Exchange Agreement
is hereby amended to include in the definition of Existing Securities the Bridge Debentures in all respects.

 

    	 	 	 

    	 

    

 

6.
[RESERVED]

 

7.
Representations and Warranties of the Company. The Company hereby makes to the Purchasers the following representations
and warranties:

 

(a)
Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate
the transactions contemplated by this Agreement and otherwise to carry out its obligations hereunder and thereunder. The execution
and delivery of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby have
been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, its
board of directors or its stockholders in connection therewith. This Agreement has been duly executed by the Company and, when
delivered in accordance with the terms hereof, will constitute the valid and binding obligation of the Company enforceable against
the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency,
reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii)
as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii)
insofar as indemnification and contribution provisions may be limited by applicable law.

 

(b)
No Conflicts. The execution, delivery and performance of this Agreement by the Company and the consummation by the Company
of the transactions contemplated hereby do not and will not: (i) conflict with or violate any provision of the Company’s
certificate or articles of incorporation, bylaws or other organizational or charter documents; or (ii) subject to the Required
Approvals, conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default)
under, result in the creation of any Lien (except as contemplated by the Security Documents) upon any of the properties or assets
of the Company in connection with, or give to others any rights of termination, amendment, acceleration or cancellation (with
or without notice, lapse of time or both) of, any material agreement, credit facility, debt or other material instrument (evidencing
Company debt or otherwise) or other material understanding to which such Company is a party or by which any property or asset
of the Company is bound or affected; or (iii) subject to the Required Approvals, conflict with or result in a violation of any
law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which
the Company is subject (including federal and state securities laws and regulations), or by which any property or asset of the
Company is bound or affected, except, in the case of each of clauses (ii) and (iii), such as could not have or reasonably be expected
to result in a Material Adverse Effect.

 

(c)
Issuance of the Bridge Debenture. The Bridge Debentures are duly authorized and, upon the execution and delivery by the
Company and the execution of this Agreement by a Purchaser, will be duly and validly issued, fully paid and nonassessable, free
and clear of all Liens imposed by the Company other than restrictions on transfer provided for in the Transaction Documents.

 

    	 	2	 

    	 

    

 

(d)
Affirmation of Prior Representations and Warranties. Except as set forth on Schedule 3(e) hereto, the Company hereby
represents and warrants to each Purchaser that the Company’s representations and warranties listed in Section 3.1 of the
Purchase Agreement are true and correct as of the date hereof.

 

8.
Representations and Warranties of the Purchaser. The Purchaser hereby represents and warrants as of the date hereof to
the Company as follows:

 

(a)
Authority. The execution, delivery and performance by such Purchaser of the transactions contemplated by this Agreement
have been duly authorized by all necessary corporate or similar action on the part of such Purchaser. This Agreement has been
duly executed by such Purchaser and, when delivered by such Purchaser in accordance with the terms hereof, will constitute the
valid and legally binding obligation of such Purchaser, enforceable against it in accordance with its terms, except (i) as limited
by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance,
injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited
by applicable law.

 

(b)
Purchaser Status. Such Purchaser is an “accredited investor” as defined in Rule 501 under the Securities Act.

 

(c)
General Solicitation. Such Purchaser is not purchasing the Bridge Debenture as a result of any advertisement, article,
notice or other communication regarding the Bridge Debenture published in any newspaper, magazine or similar media or broadcast
over television or radio or presented at any seminar or any other general solicitation or general advertisement.

 

9.
Form 8-K. The Company shall by 9:00 a.m. ET on June 25, 2019 file a Current Report on Form 8-K, including the Transaction
Documents as exhibits thereto, with the Commission. From and after the filing of such Form 8-K, the Company represents to the
Purchasers that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers by the
Company or any of its Subsidiaries, or any of their respective officers, directors, employees or agents in connection with the
transactions contemplated by the Transaction Documents. In addition, effective upon the filing of such Form 8-K, the Company acknowledges
and agrees that any and all confidentiality or similar obligations under any agreement, whether written or oral, between the Company,
any of its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates on the one hand, and any
of the Purchasers or any of their Affiliates on the other hand, shall terminate.

 

    	 	3	 

    	 

    

 

10.
Effect on Transaction Documents. Except as expressly set forth above, all of the terms and conditions of the Transaction
Documents shall continue in full force and effect after the execution of this Agreement and shall not be in any way changed, modified
or superseded by the terms set forth herein, including, but not limited to, any other obligations the Company may have to the
Purchaser under the Transaction Documents. Notwithstanding the foregoing, this Agreement shall be deemed for all purposes as an
amendment to any Transaction Document as required to serve the purposes hereof, and in the event of any conflict between the terms
and provisions of the Debentures or any other Transaction Document, on the one hand, and the terms and provisions of this Agreement,
on the other hand, the terms and provisions of this Agreement shall prevail.

 

11.
Amendments and Waivers. The provisions of this Agreement, including the provisions of this sentence, may not be amended,
modified or supplemented, and waivers or consents to departures from the provisions hereof may not be given, unless the same shall
be in writing and signed by the Company and each Purchaser.

 

12.
Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall
be delivered as set forth in the Purchase Agreement.

 

13.
Successors and Assigns. This Agreement shall inure to the benefit of and be binding upon the successors and permitted assigns
of each of the parties and shall inure to the benefit of each Purchaser. The Company may not assign (except by merger) its rights
or obligations hereunder without the prior written consent of the Purchaser of the then-outstanding Securities. The Purchaser
may assign their rights hereunder in the manner and to the Persons as permitted under the Purchase Agreement.

 

14.
Execution and Counterparts. This Agreement may be executed in two or more counterparts, all of which when taken together
shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and
delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any
signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature
shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same
force and effect as if such facsimile or “.pdf” signature page were an original thereof.

 

15.
Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall
be determined in accordance with the provisions of the Purchase Agreement.

 

16.
Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction
to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein
shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use
their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result
as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention
of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any
of such that may be hereafter declared invalid, illegal, void or unenforceable.

 

17.
Headings. The headings in this Agreement are for convenience only, do not constitute a part of the Agreement and shall
not be deemed to limit or affect any of the provisions hereof.

 

18.
Personal Guarantee. Christopher Diamantis hereby, jointly and severally, unconditionally and irrevocably, guarantees to
each Purchaser the prompt and complete payment and performance when due (whether at the stated maturity, by acceleration or otherwise)
in indefeasible payment in full of the March Debentures and the June Debentures.

 

19.
Fees and Expenses. At the closing, the Company has agreed to reimburse the Purchasers $20,000 for their fees and expenses.

 

[SIGNATURE
PAGE FOLLOWS]

 

    	 	4	 

    	 

    

 

Executed
as of the first date written above by the undersigned duly authorized representatives of the Company and the Purchaser:

 

RENNOVA
HEALTH, INC.

 

	By:
    	 	 
	Name: 
    	 	 
	Title:	 	 

 

Name
of Purchaser:

 

Signature
of Authorized Signatory: Sabby Healthcare Master Fund, Ltd.

 

Name
of Authorized Signatory: Robert Grundstein

 

Title
of Authorized Signatory: COO of Investment Manager

 

Purchase
Price: $510,000.00

 

Name
of Purchaser:

 

Signature
of Authorized Signatory: Sabby Volatility Warrant Master Fund, Ltd.

 

Name
of Authorized Signatory: Robert Grundstein

 

Title
of Authorized Signatory: COO of Investment Manager

 

Purchase
Price: $510,000.00

 

    	 	5	 

    	 

    

 

[RNVA
BRIDGE DEBENTURE AGREEMENT – SECTION 18]

 

Solely
with respect to the personal guarantee obligations under Section 18:

 

	 	 
	Christopher
    Diamantis	 

 

    	 	6

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