Exhibit
10.7


 


CERTAIN CONFIDENTIAL INFORMATION
IN THIS EXHIBIT WAS OMITTED BY MEANS OF MARKING SUCH INFORMATION WITH BRACKETS (“[***]”) BECAUSE THE IDENTIFIED CONFIDENTIAL
INFORMATION IS NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.


 


MASTER
CONSULTANCY AGREEMENT


 


Date:
25th June 2020
(“Effective
Date”)


 


	BETWEEN	Clinical Network
    Services (CNS) Pty Ltd
	 	ABN: 45 082 063 492
	 	Level 2,
    381 MacArthur Avenue,
    Hamilton, Queensland, 4007, Australia
	 	(“Consultant”)
	 	 
	AND	
	 	lnCannex Pty Ltd
	 	ABN 33
    630 326 902
	 	3 Fir Street, Dingley Village VIC 3172,
    Australia
	 	(“Client”)


 


BACKGROUND


 


		A.	The
Consultant is
a contract services organisation engaged
in the
business of product development
and managing clinical research
programs.



 


		B.	The
Client is engaged
in
the development,
manufacture,
distribution and sale of medicinal products.



 


		C.	The
Client wishes to
appoint the Consultant to
supply
certain
services
to
the
Client and its
affiliates in
relation to medicinal
products from
time
to time
and the
Consultant has agreed to
provide those
services on the
terms and
conditions
set out in this Agreement
and the attached
Appendices.



 


TERMS
& CONDITIONS


 


		1.	MEANINGS
AND DEFINITIONS



 


“Affiliate”
shall
mean any company
or business
entity
that controls,
is controlled
by, or
is
under
common control
with either party, as the
context requires.
For the
purpose of this
definition
“control”,
means direct or indirect
beneficial ownership or the right
to vote in
respect of at least
fifty percent (50%)
of the
issued share capital
in such company
or business
entity.


 


“Agreement”
means this agreement between
the
Client
and the
Consultant
for the provision of
the
Services by
the
Consultant in
accordance with an Appendix.


 


“Appendix”
means an offer
to provide
the Services
that has been agreed to
in writing
by the parties,
and
attached and made a part
of
this Agreement.
The
first
Appendix being attached as Appendix
1 (and each
subsequent Appendix that
is agreed
to in
writing
by the
parties will be attached as Appendix
2, 3, and so forth
and made
a part hereof).


 


“Budget”
means, on an
Appendix by Appendix
basis, the
total amount to
be paid by Client
to Consultant
for its
Services under
this Agreement
as set
forth in
an
Appendix to
this
Master Consultancy
Agreement that
is agreed upon
in writing by the
parties pursuant to
each such Appendix.
Each Budget shall contain Consultant’s
Fees and Pass Through Costs.


 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 1 of 29



     


    

 


“Confidential
Information” is defined in Section
10.2.


 


“Data”
is defined in Section 10.3.


 


“Fees”
means professional time costs and
any other
costs required to be
paid by the
Client to the Consultant
as specified in an Appendix.


 


“Intellectual
Property Rights” means any
patents, trademarks,
designs or applications
for them,
copyright, rights in and
to trade or
business
names, know-how or confidential
information, and any
similar or
analogous rights or
forms of
protection
in any part of the world.


 


“lnvestigational Product”
means the
therapeutic good
(including any
components such as devices, accessories
and consumables necessary for
the administration and use of
the therapeutic good),
that is manufactured or supplied
by or
on behalf
of Client for
the purpose of administration and use
in the conduct
of a Study.


 


“lnvestigational
Site” means a
clinical trial site where a
Study is
conducted.


 


“Investigator”
means an investigator at an
lnvestigational
Site.


 


“Laws”
is defined in
Section 5.2.


 


“Local
Regulators” is defined in Section
5.1.


 


“Pass
Through Costs” means those
direct and indirect expenses and costs incurred
by
the Consultant in carrying
out the Services
required to complete
a Study, as expressly
set forth in a Budget or otherwise agreed by the parties.


 


“Protocol”
means
a written
description of tasks and
procedures (including the
schedule,
number
of Study Subjects and other specific
requirements for
conducting a Study) to be
followed in conducting
a Study. A Protocol
may be
amended from time to time accordingly,
the term Protocol refers to the then-current
authorized Protocol.


 


“Records”
is defined in
Section 13.


 


“Services”
means those
consultancies and other activities referred
to in an Appendix and such expression
includes
the duties
to be undertaken under
the Scope
of Work associated with such an
Appendix.


 


“Scope
of Work” or “SOW”
means
the Scope
of Work
included in
an
Appendix, and includes
the specific details of the
Services that
Consultant shall provide, including
the timelines, Budget and
payment schedule, all of which shall
be agreed by the parties.
Each SOW is an
integral part of an Appendix to
which it
relates.


 


“Study”
means the human
clinical trial or clinical trials
as set out in
an Appendix and as described in the
Protocol
governing
such trial(s).


 


“Study
Subject” is a human
being who participates in a Study.


 


“Term”
is defined in
Section 2.


 


		2.	TERM



 


		2.1.	The
                                            term of this
                                            Master
                                            Consultancy Agreement shall commence
                                            on the Effective
                                            Date and,
                                            shall
                                            expire on the
                                            fifth anniversary
                                            of the Effective Date unless
                                            terminated
                                            earlier in
                                            accordance
                                            with Section
                                            8 (“Term”).



 


		2.2.	Each
                                            Appendix shall commence on the
                                            effective
                                            date set out in
                                            that
                                            Appendix
                                            and that
                                            Appendix
                                            shall expire upon the
                                            completion
                                            of
                                            the
                                            Services
                                            under
                                            that Appendix
                                            unless
                                            terminated
                                            earlier in
                                            accordance
                                            with Section 8 [Termination)



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 2 of 29



     


    

 


		3.	STRUCTURE
OF AGREEMENT



 


		3.1.	If the Client
                                                                                                                                                                    and the Consultant agree that the
                                                                                                                                                                    Consultant
                                                                                                                                                                    shall supply the Services as set out in an Appendix, the Client and
                                                                                                                                                                    the Consultant shall execute that Appendix
                                                                                                                                                                    which the Client and the
                                                                                                                                                                    Consultant
                                                                                                                                                                    shall complete and execute at
                                                                                                                                                                    that time. Each Appendix
                                                                                                                                                                    incorporatesthe terms
                                                                                                                                                                    of this Master Consultancy
                                                                                                                                                                    Agreement by reference.



 


		3.2.	The
                                                                                                                                                                    Client or an Affiliate
                                                                                                                                                                    of the
                                                                                                                                                                    Client may
                                                                                                                                                                    enter into an
                                                                                                                                                                    Appendix with
                                                                                                                                                                    the Consultant.
                                                                                                                                                                    Where an Affiliate
                                                                                                                                                                    of a
                                                                                                                                                                    Client enters into an Appendix, all
                                                                                                                                                                    references to
                                                                                                                                                                    the Client
                                                                                                                                                                    in this Master Consultancy
                                                                                                                                                                    Agreement as incorporated
                                                                                                                                                                    by reference into
                                                                                                                                                                    an Appendix shall automatically
                                                                                                                                                                    refer to the Affiliate
                                                                                                                                                                    of the
                                                                                                                                                                    Client that is
                                                                                                                                                                    the party to the Appendix. The
                                                                                                                                                                    Client acknowledges
                                                                                                                                                                    and agrees that CNSmay at itsdiscretion
                                                                                                                                                                    use its
                                                                                                                                                                    Affiliates to provide the
                                                                                                                                                                    Services (including, for
                                                                                                                                                                    the avoidance
                                                                                                                                                                    of doubt, CNS
                                                                                                                                                                    (Australia) Pty
                                                                                                                                                                    Limited and its
                                                                                                                                                                    Affiliates).
                                                                                                                                                                    CNS will be responsible to the Client
                                                                                                                                                                    for the acts or omissions
                                                                                                                                                                    of its Affiliates in
                                                                                                                                                                    the performance
                                                                                                                                                                    of the Services.



 


		3.3.	In
                                            the
                                            event
                                            of
                                            a
                                            conflict
                                            between
                                            the
                                            terms
                                            of this
                                            Master
                                            Consultancy
                                            Agreement
                                            and
                                            an Appendix,
                                            the
                                            terms
                                            of the
                                            following
                                            prevail in the
                                            following
                                            order
                                            unless
                                            specified
                                            otherwise
                                            in
                                            the Appendix
                                            in
                                            which
                                            case the Appendix, as
                                            the
                                            case may
                                            be,
                                            will
                                            control
                                            solely
                                            with respect
                                            to
                                            that
                                            conflict:



 


		3.3.1. Master	Consultancy
Agreement;



 


		 	3.3.2.Appendix



 


		3.4.	In
                                            the
                                            event that
                                            the
                                            Client
                                            requests
                                            the
                                            Consultant
                                            to
                                            commence
                                            providing
                                            Services
                                            before the
                                            execution
                                            of an Appendix for
                                            those
                                            Services,
                                            the
                                            parties shall
                                            execute
                                            a
                                            Letter of Intent.
                                            In
                                            the
                                            event
                                            of
                                            a
                                            conflict
                                            between
                                            the
                                            terms
                                            of this Master
                                            Consultancy
                                            Agreement
                                            and
                                            a Letter
                                            of Intent,
                                            the
                                            terms of
                                            this
                                            Master
                                            Consultancy
                                            Agreement
                                            prevail.



 


		4.	AMENDMENT



 


Any
amendment, variation
or
modification to
this
Agreement or
an Appendix
or any other supplementary or
supporting document (including
any
SOW) shall have
no force
and effect
unless evidenced
in writing
and signed
by the parties. If
the parties
agree to
a change
in an
Appendix, such
change shall
be documented in
a written
addendum signed by both
parties (“Addendum”),
which
Addendum
shall become an
amendment to
the relevant Appendix.
Notwithstanding the
foregoing, a change
to
an Appendix
that results
in an
increase
or decrease to a
Budget of less
than five thousand dollars
(A$5,000.00) shall
not require
an Addendum
but such
changes
must be approved in
advance by
the Client
via email
with CNS.


 


		5.	SERVICES



 


		5.1.	The Consultant
                                                                                                                                                                                     will act
                                                                                                                                                                                     as the local
                                                                                                                                                                                     legal Australian and/or
                                                                                                                                                                                     New Zealand
                                                                                                                                                                                     sponsor on
                                                                                                                                                                                     behalf of the Client
                                                                                                                                                                                     as set out in
                                                                                                                                                                                     the Appendix,
                                                                                                                                                                                     and will fulfil all obligations
                                                                                                                                                                                     that this role
                                                                                                                                                                                     entails, including the maintenance
                                                                                                                                                                                     of appropriate clinical trial
                                                                                                                                                                                     insurance unless otherwise set out
                                                                                                                                                                                     in an
                                                                                                                                                                                     Appendix to this
                                                                                                                                                                                     Agreement. The
                                                                                                                                                                                     Consultant
                                                                                                                                                                                     shall, to the extent
                                                                                                                                                                                     required by Laws, interact with Therapeutic
                                                                                                                                                                                     Goods Administration (Australia) and/or
                                                                                                                                                                                     Medsafe (New Zealand) (collectively, “Local Regulators”) on
                                                                                                                                                                                     behalf
                                                                                                                                                                                     of Client in
                                                                                                                                                                                     connection
                                                                                                                                                                                     with the performance of
                                                                                                                                                                                     Serviceshereunder, including
                                                                                                                                                                                     but not necessarily limited
                                                                                                                                                                                     to signing regulatory submissions
                                                                                                                                                                                     and other
                                                                                                                                                                                     documents to be filed
                                                                                                                                                                                     with Local Regulators
                                                                                                                                                                                     on behalf of the Client. The Consultant shall in a timely
                                                                                                                                                                                     manner,
                                                                                                                                                                                     communicate with the
                                                                                                                                                                                     Client with regard to
                                                                                                                                                                                     all such interactions, including copying the
                                                                                                                                                                                     Client on
                                                                                                                                                                                     any and all written communications
                                                                                                                                                                                     with Local Regulators
                                                                                                                                                                                     on behalf of
                                                                                                                                                                                     the Client and
                                                                                                                                                                                     summarising in writing for the Client all oral communications
                                                                                                                                                                                     with Local Regulators
                                                                                                                                                                                     on behalf of the Client.






 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 3 of 29



     


    

 


		5.2.	The Consultant
                                                                                                                                                                   shall provide
                                                                                                                                                                   the Services
                                                                                                                                                                   as set out
                                                                                                                                                                   in each Appendix. The Consultant shall perform the
                                                                                                                                                                   Services in compliance
                                                                                                                                                                   with: (a)
                                                                                                                                                                   the Protocol; (b) the
                                                                                                                                                                   terms
                                                                                                                                                                   and conditions
                                                                                                                                                                   of this
                                                                                                                                                                   Agreement and the applicable Appendices;
                                                                                                                                                                   (c) all applicable federal, state
                                                                                                                                                                   and local
                                                                                                                                                                   laws, rules, regulations and guidelinesincluding but
                                                                                                                                                                   not limited to applicable
                                                                                                                                                                   requirements and guidelines
                                                                                                                                                                   of the Local Regulators,
                                                                                                                                                                   and patient privacy laws
                                                                                                                                                                   and regulations (collectively, “Laws”); (d) the International Conference
                                                                                                                                                                   on Harmonisation (“ICH”)
                                                                                                                                                                   Guidelines for Good Clinical Practices (“GCP”); (e)
                                                                                                                                                                   the World Medical Association’s Declaration
                                                                                                                                                                   of Helsinki
                                                                                                                                                                   (1996
                                                                                                                                                                   version);
                                                                                                                                                                   (f) its Standard Operating Procedures (“SOPs”);
                                                                                                                                                                   (g) any authorisation for
                                                                                                                                                                   the Study issued
                                                                                                                                                                   by a Local Regulator; and (h) the
                                                                                                                                                                   terms
                                                                                                                                                                   and conditions
                                                                                                                                                                   of the favourable opinion
                                                                                                                                                                   of the relevant ethics
                                                                                                                                                                   committee for the
                                                                                                                                                                   Study.



 


		5.3.	Consultant
                                                                                                                                                                   represents and warrants that:
                                                                                                                                                                   (a) it has the
                                                                                                                                                                   requisite facilities,
                                                                                                                                                                   equipment,
                                                                                                                                                                   and personnel with the requisite training, expertise, qualification, experience
                                                                                                                                                                   and skill,
                                                                                                                                                                   to render the
                                                                                                                                                                   Services, and Consultant
                                                                                                                                                                   shall render the
                                                                                                                                                                   Services, in a timely, competent, and
                                                                                                                                                                   efficient manner in accordance
                                                                                                                                                                   with this
                                                                                                                                                                   Agreement; (b)
                                                                                                                                                                   it will devote itsgood faith effortsto accurately and
                                                                                                                                                                   efficiently
                                                                                                                                                                   perform the
                                                                                                                                                                   Servicesrequired under
                                                                                                                                                                   this Agreement;
                                                                                                                                                                   and (c) it
                                                                                                                                                                   is not a
                                                                                                                                                                   party to a contract
                                                                                                                                                                   and will not enter into any
                                                                                                                                                                   contract,
                                                                                                                                                                   that would prevent it
                                                                                                                                                                   from fulfilling its
                                                                                                                                                                   obligations
                                                                                                                                                                   or materially interfere
                                                                                                                                                                   with the rights of the Client
                                                                                                                                                                   under this
                                                                                                                                                                   Agreement.



 


		6.	FEES
AND PASS
THROUGH COSTS



 


		6.1.	The Consultant
                                                                                                                                                                   shall deliver to the
                                                                                                                                                                   Client
                                                                                                                                                                   an invoice for payment of the Fees
                                                                                                                                                                   and Pass Through
                                                                                                                                                                   Costs at the
                                                                                                                                                                   times
                                                                                                                                                                   set out in an
                                                                                                                                                                   Appendix
                                                                                                                                                                   and
                                                                                                                                                                   as otherwise
                                                                                                                                                                   expressly
                                                                                                                                                                   agreed in writing
                                                                                                                                                                   by the parties. All
                                                                                                                                                                   references to dollars or
                                                                                                                                                                   money shall be
                                                                                                                                                                   read as being in Australian
                                                                                                                                                                   Dollars unless otherwise
                                                                                                                                                                   stated. Where the
                                                                                                                                                                   Client reasonably
                                                                                                                                                                   requests, the Consultant
                                                                                                                                                                   shall provide to the
                                                                                                                                                                   Client explanationsor further information
                                                                                                                                                                   regarding
                                                                                                                                                                   any invoice
                                                                                                                                                                   delivered
                                                                                                                                                                   by the
                                                                                                                                                                   Consultant.



 


		6.2.	The
                                                                                                                                                                   Client shall pay to the
                                                                                                                                                                   Consultant all amounts
                                                                                                                                                                   properly
                                                                                                                                                                   due and undisputed in the
                                                                                                                                                                   manner and at
                                                                                                                                                                   the times set out in an Appendix and as otherwise
                                                                                                                                                                   expressly
                                                                                                                                                                   agreed in writing
                                                                                                                                                                   by the
                                                                                                                                                                   parties. If the
                                                                                                                                                                   due date for payment of any amountsis not set out
                                                                                                                                                                   in an Appendix or
                                                                                                                                                                   otherwise agreed by the parties,
                                                                                                                                                                   the Client
                                                                                                                                                                   shall pay the amounts properly due and
                                                                                                                                                                   undisputed in
                                                                                                                                                                   respect of any validly
                                                                                                                                                                   presented invoice within
                                                                                                                                                                   30 days of the date of receipt by the
                                                                                                                                                                   Client
                                                                                                                                                                   of the
                                                                                                                                                                   Consultant’sinvoice
                                                                                                                                                                   for those
                                                                                                                                                                   amounts. For
                                                                                                                                                                   invoices where costs are
                                                                                                                                                                   being passed through
                                                                                                                                                                   directly from
                                                                                                                                                                   third party vendors (including investigator
                                                                                                                                                                   sites),
                                                                                                                                                                   the Client
                                                                                                                                                                   shall pay the
                                                                                                                                                                   amounts
                                                                                                                                                                   properly
                                                                                                                                                                   due and undisputed in
                                                                                                                                                                   respect of any validly
                                                                                                                                                                   presented
                                                                                                                                                                   invoice within 14 days
                                                                                                                                                                   of the date
                                                                                                                                                                   of receipt by the Client of the
                                                                                                                                                                   Consultant’s invoice for those amounts.
                                                                                                                                                                   When making
                                                                                                                                                                   a payment,
                                                                                                                                                                   the Client must quote
                                                                                                                                                                   relevant
                                                                                                                                                                   reference numbers and the invoice number.



 


		6.3.	Within
                                            30
                                            days or 14 days (whichever
                                            is applicable),
                                            of the
                                            date
                                            of receipt
                                            by
                                            the Client
                                            of
                                            an invoice
                                            from the Consultant,
                                            the
                                            Client
                                            shall
                                            notify
                                            the Consultant
                                            of any genuinely
                                            disputed
                                            amount and the
                                            reasons
                                            for
                                            the
                                            dispute.
                                            If
                                            no
                                            dispute
                                            is
                                            raised
                                            by the Client
                                            to
                                            the Consultant
                                            in
                                            relation
                                            to
                                            an invoice,
                                            the
                                            invoice
                                            is
                                            deemed to be undisputed.



 


		6.4.	The
                                            Client
                                            shall
                                            pay
                                            all
                                            disputed
                                            amounts
                                            in
                                            respect
                                            of
                                            any invoice
                                            within 30 days or 14
                                            days (whichever is applicable),
                                            of the
                                            dispute
                                            being resolved
                                            by the
                                            parties.



 


		6.5.	The
                                            Client
                                            shall
                                            pay
                                            all
                                            amounts
                                            properly
                                            due
                                            and undisputed
                                            under this Agreement in
                                            full
                                            without
                                            any set-off, counterclaim,
                                            deduction
                                            or
                                            withholding
                                            (other
                                            than any deduction
                                            or withholding
                                            of tax
                                            as required
                                            by law).



 


		6.6.	Where
                                            Client
                                            fails
                                            to
                                            pay any part
                                            of
                                            an undisputed
                                            invoice within
                                            the
                                            agreed
                                            period,
                                            an additional
                                            administrative
                                            charge of 2% per month
                                            of
                                            the undisputed
                                            value
                                            of an invoice will be
                                            invoiced
                                            to the Client by the
                                            Consultant
                                            until such time
                                            as
                                            payment
                                            is made and
                                            the
                                            Consultant
                                            may
                                            suspend
                                            provision
                                            of the
                                            Services until
                                            payment
                                            of
                                            the
                                            overdue
                                            amount
                                            payable
                                            is
                                            received
                                            by
                                            the Consultant
                                            in
                                            cleared funds.






 


		6.7.	The
                                            parties agree
                                            that
                                            the
                                            Fees and
                                            Pass Through Costs,
                                            including
                                            both
                                            unit
                                            based
                                            and additional
                                            Pass
                                            Through Costs
                                            not
                                            contained
                                            in
                                            unit
                                            prices,
                                            as set forth
                                            in
                                            Appendices
                                            to
                                            this
                                            Agreement are
                                            reasonable and
                                            at
                                            fair market
                                            value
                                            and
                                            shall
                                            not
                                            take into account
                                            the
                                            volume
                                            or value
                                            of any
                                            referrals,
                                            purchases
                                            or business
                                            otherwise
                                            generated
                                            by Consultant.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 4 of 29



     


    

 


		7.	GST



 


		7.1.	“GST’’
                                            means
                                            any
                                            goods and services
                                            tax payable
                                            under
                                            the
                                            A New
                                            Tax System
                                            (Goods and Services Act
                                            1999
                                            Commonwealth), consumption tax,
                                            value
                                            added
                                            tax
                                            or
                                            like
                                            tax.



 


		7.2.	The
                                            Client
                                            acknowledges
                                            that all
                                            Fees
                                            and Pass Through
                                            Costs are
                                            stated
                                            exclusive of any GST or any other
                                            taxes
                                            that
                                            may be applicable
                                            under
                                            law
                                            and therefore,
                                            the
                                            Consultant
                                            shall
                                            be entitled
                                            to add on GST and other
                                            applicable
                                            taxes.



 


		7.3.	If
                                            GST
                                            is
                                            payable
                                            by
                                            the
                                            Consultant
                                            on
                                            any Fees
                                            and Pass
                                            Through
                                            Costs,
                                            the Client
                                            must
                                            pay
                                            to
                                            the
                                            Consultant
                                            the
                                            amount equal to
                                            the GST payable
                                            in
                                            addition
                                            to
                                            the
                                            amount of the
                                            Fees
                                            and
                                            Pass
                                            Through Costs
                                            as
                                            set
                                            out
                                            in
                                            the
                                            invoices.



 


		8.	TERMINATION



 


		8.1.	This
                                            Agreement
                                            and any Appendix may be terminated:



 


		8.1.1.	by
the Consultant
immediately
by written
notice to
the Client if the
Client
fails to
supply
the lnvestigational
Product as required for
the
performance
of a
Study;



 


		8.1.2.	by either
                                                                                                                                                                                                        party immediately
                                                                                                                                                                                                        by written notice to the other
                                                                                                                                                                                                        party if the other
                                                                                                                                                                                                        party isdeclared bankrupt,
                                                                                                                                                                                                        has an administrator, receiver or
                                                                                                                                                                                                        receiver/manager or a liquidator is
                                                                                                                                                                                                        appointed to it, or enters
                                                                                                                                                                                                        into a deed of arrangement or an
                                                                                                                                                                                                        order is made
                                                                                                                                                                                                        for it
                                                                                                                                                                                                        to be wound up, or the
                                                                                                                                                                                                        other party
                                                                                                                                                                                                        would
                                                                                                                                                                                                        be presumed to be insolvent
                                                                                                                                                                                                        by a court in
                                                                                                                                                                                                        any of the circumstances
                                                                                                                                                                                                        referred to in the Corporations
                                                                                                                                                                                                        Act 2001 (cth) or equivalent
                                                                                                                                                                                                        applicable law;



 


		8.1.3.	by
                                            the
                                            Consultant
                                            immediately
                                            by written
                                            notice
                                            to
                                            the
                                            Client
                                            where the
                                            Consultant
                                            is acting as
                                            a
                                            local
                                            Sponsor
                                            on behalf
                                            of
                                            the
                                            Client
                                            and the
                                            Consultant
                                            can no longer
                                            fulfil
                                            that role for
                                            any
                                            reason including,
                                            but
                                            not
                                            limited
                                            to,
                                            legal,
                                            moral
                                            or
                                            ethical
                                            reasons;



 


		8.1.4.	by
                                            the
                                            Consultant
                                            immediately
                                            by
                                            written notice
                                            to
                                            the
                                            Client
                                            if
                                            any
                                            of the
                                            undisputed
                                            Fees
                                            or
                                            Pass Through Costs remain
                                            unpaid
                                            for
                                            a
                                            period of
                                            more
                                            than 30 days after the
                                            due
                                            date
                                            for payment, provided that
                                            Consultant
                                            has given Client
                                            no
                                            less than
                                            15
                                            days
                                            written
                                            notice
                                            of
                                            such intention
                                            to
                                            terminate
                                            and
                                            Client
                                            has
                                            the opportunity
                                            to
                                            make such
                                            undisputed
                                            payment by the
                                            end
                                            of such 15
                                            day period
                                            to
                                            avoid
                                            termination;



 


		8.1.5.	by
                                            either
                                            party
                                            immediately by written
                                            notice
                                            to the
                                            other party where the
                                            other party has
                                            materially
                                            breached
                                            this
                                            Agreement or
                                            an Appendix and where the
                                            other party has failed
                                            to
                                            remedy
                                            that
                                            breach within
                                            30 days
                                            of
                                            the
                                            date
                                            of
                                            service
                                            of a written notice from the
                                            first party
                                            specifying the breach and requiring
                                            that it
                                            be
                                            remedied;



 


		8.1.6.	by
                                            either
                                            party
                                            immediately
                                            by
                                            written notice to
                                            the
                                            other
                                            party
                                            where the
                                            other
                                            party has
                                            materially
                                            breached this
                                            Agreement or an Appendix
                                            and that
                                            breach
                                            is incapable
                                            of remedy; and



 


		8.1.7.	by
                                            either
                                            party in accordance with Section
                                            17.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 5 of 29



     


    

 


		8.2.	The
expiry or termination
of one Appendix
does not terminate another
Appendix or this
Agreement. The early
termination
of this
Agreement terminates
all Appendices.
Despite the
expiry of the
Term of this
Agreement,
the
Agreement is
deemed to continue
and apply to
any outstanding
Appendices
until the
expiry or earlier
termination of
that Appendix.



 


		8.3.	In
                                            event
                                            of termination
                                            of this
                                            Agreement
                                            (and
                                            all
                                            Appendices)
                                            or any Appendix
                                            by either
                                            party,
                                            Client
                                            shall
                                            pay
                                            undisputed
                                            amounts
                                            owed
                                            to
                                            Consultant
                                            in
                                            relation
                                            to
                                            this
                                            Agreement
                                            (and
                                            all
                                            Appendices)
                                            or
                                            the
                                            Appendix,
                                            as relevant,
                                            through
                                            to
                                            the
                                            date of
                                            termination
                                            including
                                            amounts reasonably
                                            incurred
                                            by the
                                            Consultant
                                            for
                                            all future
                                            non-cancellable
                                            obligations
                                            provided
                                            however
                                            Consultant
                                            shall
                                            use
                                            it
                                            best efforts in winding down the
                                            Services
                                            to minimize
                                            any costs
                                            and
                                            to
                                            minimize
                                            incurring
                                            additional
                                            Fees and Pass-Through Costs.



 


		8.4.	Upon
                                            receipt
                                            of
                                            any
                                            notice of
                                            termination
                                            hereunder,
                                            Consultant
                                            shall
                                            limit
                                            its
                                            work
                                            to
                                            that
                                            which
                                            is
                                            necessary
                                            to
                                            orderly
                                            close
                                            out
                                            a
                                            Study
                                            and
                                            comply
                                            with
                                            Laws,
                                            and shall
                                            use
                                            commercially
                                            reasonable
                                            efforts
                                            to
                                            conclude
                                            or transfer
                                            any
                                            Study as
                                            instructed
                                            by
                                            Client
                                            as soon as
                                            practicable
                                            and
                                            in accordance
                                            with Laws
                                            and
                                            the
                                            Client
                                            shall
                                            pay
                                            the
                                            Consultant
                                            all
                                            reasonable
                                            costs
                                            incurred
                                            by the Consultant
                                            in
                                            relation
                                            to
                                            the
                                            closing
                                            out
                                            a
                                            Study
                                            or
                                            transferring
                                            a
                                            Study.



 


		8.5.	Upon the request of
                                                                                                                                                                                                       Client during the Term and
                                                                                                                                                                                                       in any event upon termination
                                                                                                                                                                                                       or the
                                                                                                                                                                                                       expiration
                                                                                                                                                                                                       of the Term, Consultant
                                                                                                                                                                                                       shall return all
                                                                                                                                                                                                       documents, information,
                                                                                                                                                                                                       research, clinical data, the
                                                                                                                                                                                                       Data, equipment, Investigational Product
                                                                                                                                                                                                       or other material received from Client or arising
                                                                                                                                                                                                       from the Services
                                                                                                                                                                                                       and a Study, including any and all derivations thereof and improvements
                                                                                                                                                                                                       thereto, and copies thereof in
                                                                                                                                                                                                       whatever form
                                                                                                                                                                                                       (including
                                                                                                                                                                                                       electronic form,
                                                                                                                                                                                                       in which
                                                                                                                                                                                                       case such copiesshall be
                                                                                                                                                                                                       destroyed
                                                                                                                                                                                                       by Consultant),
                                                                                                                                                                                                       subject only to Consultant’s
                                                                                                                                                                                                       obligations under Section 13.



 


		8.6.	In the
                                                                                                                                                                                                       event of termination
                                                                                                                                                                                                       or the expiration
                                                                                                                                                                                                       of this
                                                                                                                                                                                                       Agreement or
                                                                                                                                                                                                       an Appendix, Sections 10.1 and
                                                                                                                                                                                                       10.2 shall survive for a
                                                                                                                                                                                                       period of
                                                                                                                                                                                                       five years from
                                                                                                                                                                                                       the date of termination or expiration
                                                                                                                                                                                                       of this Agreement or the Appendix,
                                                                                                                                                                                                       and Sections
                                                                                                                                                                                                       6, 8.2,
                                                                                                                                                                                                       8.3, 8.4, 8.5, 8.6,
                                                                                                                                                                                                       10.3, 10.4, 10.5, 10.6,
                                                                                                                                                                                                       10.7, 10.8, 11,
                                                                                                                                                                                                       12.2, 12.3, 12.4, 12.5, 13,
                                                                                                                                                                                                       188, and 19 shall survive
                                                                                                                                                                                                       and the parties
                                                                                                                                                                                                       shall remain
                                                                                                                                                                                                       bound by such Sections
                                                                                                                                                                                                       in relation to their
                                                                                                                                                                                                       rights and obligationsunder this Agreement or the Appendix as relevant. Expiration
                                                                                                                                                                                                       or termination will not
                                                                                                                                                                                                       affect the
                                                                                                                                                                                                       parties’
                                                                                                                                                                                                       rights
                                                                                                                                                                                                       and obligations
                                                                                                                                                                                                       accrued as of the date
                                                                                                                                                                                                       of such expiration
                                                                                                                                                                                                       or termination,
                                                                                                                                                                                                       or preclude a
                                                                                                                                                                                                       party from obtaining any
                                                                                                                                                                                                       remedy or seeking
                                                                                                                                                                                                       any damages or equitable
                                                                                                                                                                                                       relief to
                                                                                                                                                                                                       which it
                                                                                                                                                                                                       may be entitled as a result of
                                                                                                                                                                                                       any breach.



 


		9.	RELATIONSHIP
AND LIMITED AUTHORITY



 


		9.1.	The
                                            Consultant
                                            shall
                                            not
                                            have,
                                            nor
                                            shall
                                            it
                                            represent
                                            itself
                                            as having
                                            any authority
                                            to
                                            commit
                                            the
                                            Client
                                            or
                                            its
                                            affiliates by negotiation or
                                            otherwise
                                            to any
                                            contract,
                                            agreement
                                            or other
                                            legal
                                            commitments
                                            in
                                            the
                                            name
                                            of
                                            or
                                            binding
                                            the
                                            Client
                                            or
                                            its
                                            affiliates
                                            or to
                                            pledge or
                                            extend
                                            credit
                                            in
                                            the
                                            name
                                            of
                                            the
                                            Client
                                            or its
                                            affiliates.
                                            The Consultant
                                            shall
                                            perform
                                            the
                                            Services
                                            as an independent
                                            contractor
                                            and not as employee,
                                            agent,
                                            joint
                                            venture
                                            or
                                            partner
                                            of the
                                            Client
                                            or
                                            its
                                            affiliates.



 


		9.2.	Subject
                                                                                                                                                                                                       to the
                                                                                                                                                                                                       provisions of clause 5.1, it
                                                                                                                                                                                                       is agreed
                                                                                                                                                                                                       that at all times, the
                                                                                                                                                                                                       Client, and not the
                                                                                                                                                                                                       Consultant, is the sponsor of
                                                                                                                                                                                                       all Studiescarried out pursuant to this Agreement
                                                                                                                                                                                                       and that the
                                                                                                                                                                                                       Client (or
                                                                                                                                                                                                       its designee), and
                                                                                                                                                                                                       not the Consultant, is the
                                                                                                                                                                                                       sole
                                                                                                                                                                                                       owner of the Investigational Products
                                                                                                                                                                                                       and any and all data,
                                                                                                                                                                                                       regulatory
                                                                                                                                                                                                       submissions
                                                                                                                                                                                                       and approvals related
                                                                                                                                                                                                       to the Investigational Products
                                                                                                                                                                                                       administered and used in any such Studies.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 6 of 29



     


    

 


		10.	CONFIDENTIALITY,
DATA PRIVACY
AND PUBLICATION



 


		10.1.	The terms and conditions
                                                                                                                                                                                                        of this
                                                                                                                                                                                                        Agreement and
                                                                                                                                                                                                        any Appendicesshall
                                                                                                                                                                                                        be considered the Confidential
                                                                                                                                                                                                        Information
                                                                                                                                                                                                        of Client. Consultant shall not make
                                                                                                                                                                                                        any disclosure regarding
                                                                                                                                                                                                        the terms and conditions
                                                                                                                                                                                                        of this
                                                                                                                                                                                                        Agreement and any Appendices
                                                                                                                                                                                                        to any third party (except to its legal and financial advisors, provided such
                                                                                                                                                                                                        individuals are
                                                                                                                                                                                                        bound by obligations
                                                                                                                                                                                                        of confidentiality substantially similar to
                                                                                                                                                                                                        those
                                                                                                                                                                                                        set forth
                                                                                                                                                                                                        herein) without
                                                                                                                                                                                                        the prior written consent of
                                                                                                                                                                                                        Client.






 


		10.2.	Consultant’s
                                            work with Client will involve access to business information and technical and other data
                                            that Client considers proprietary and therefore of a confidential nature. All such information
                                            or data in whatever form including all copies and derivations thereof or improvements thereto
                                            (“Confidential Information”) shall be the sole property of Client and shall
                                            be treated by Consultant as confidential in character and of a proprietary nature. Consultant
                                            shall not disclose Confidential Information to third parties other than its employees and
                                            subcontractors on a need to know basis or use Confidential Information for Consultant’s own
                                            benefit at any time, without Client’s prior written consent. Consultant shall use Confidential
                                            Information for the sole purpose of carrying out Services under this Agreement. Client’s
                                            Confidential Information shall also include, without limitation, the Dato; information regarding
                                            Client’s business; the Client’s Intellectual Property Rights; the Client’s drug products
                                            and proposed drug products; current or proposed studies on Client’s products, any research
                                            and resultsof studies on Client’s drug products; and analyses, reports and decisions resulting
                                            from clinical trials or studies on Client’s drug products. For the avoidance of doubt, references
                                            herein to drug products include lnvestigotionol Products and references herein to studiesinclude
                                            any Study.



 


	 	10.3.	Any and all clinical data, information and materials arising from or
related to a Study and the performance of the Services or a Study in whatever form (including all copies and derivations thereof or improvements
thereto) (“Data”) is the sole property of Client, and the Consultant hereby assigns all rights, title and interest in
the Data to the Client upon its creation. Upon the request of Client or within sixty (60) days of conclusion of a Study, or upon the termination
or expiration of this Agreement, the Consultant shall provide the Doto and all copies thereof to the Client and shall destroy any electronic
versions thereof, subject only to Consultant’s obligations under Section 13.



 


		10.4.	Consultant
                                            will
                                            maintain
                                            the
                                            confidentiality
                                            of
                                            and
                                            not
                                            disclose
                                            any
                                            Study
                                            Subject’s
                                            Doto collected
                                            during
                                            a
                                            Study
                                            and
                                            will protect
                                            the
                                            privacy of
                                            the
                                            Study Subjects, all
                                            in
                                            accordance
                                            with the
                                            Laws,
                                            unless
                                            such
                                            disclosure
                                            is
                                            required by
                                            the
                                            Laws.
                                            The
                                            Consultant
                                            shall
                                            only
                                            collect,
                                            use,
                                            store,
                                            transfer,
                                            delete,
                                            disclose
                                            or
                                            otherwise
                                            process
                                            a Study Subject’s personal
                                            information
                                            or
                                            personal
                                            data
                                            collected
                                            under
                                            a
                                            Study in
                                            accordance
                                            with
                                            the
                                            instructions
                                            of
                                            the
                                            Client
                                            and as
                                            reasonably
                                            required
                                            in
                                            connection
                                            with
                                            the performance
                                            of
                                            the
                                            Services.



 


		10.5 	Sections
                                                                                                                                                                                                       10.1, 10.2
                                                                                                                                                                                                       and 10.4 do not apply
                                                                                                                                                                                                       to Confidential Information or Data
                                                                                                                                                                                                       which:



 


		10.5.1.	is
in or
becomes part
of the
public domain
other
than
through
breach
of this
Agreement or
on obligation
of confidence
owed to the
Client;



 


		10.5.2.	the
                                            Consultant
                                            can
                                            prove
                                            by contemporaneous
                                            written
                                            documentation
                                            was already
                                            known to
                                            it at
                                            the
                                            time
                                            of disclosure
                                            by
                                            the
                                            Client
                                            (unless
                                            that
                                            knowledge
                                            arose
                                            from
                                            disclosure of
                                            information
                                            in
                                            breach of on obligation
                                            of
                                            confidence);



 


		10.5.3.	the
                                            Consultant
                                            acquires
                                            from
                                            a
                                            source
                                            other
                                            than
                                            the
                                            Client,
                                            its
                                            Affiliates
                                            or
                                            any
                                            employees,
                                            agents,
                                            officers,
                                            directors,
                                            auditors,
                                            advisers, partners, consultants,
                                            licensees,
                                            sublicensees,
                                            joint
                                            venturers or subcontractors of the
                                            Client
                                            or its Affiliates
                                            where that
                                            source
                                            is
                                            entitled
                                            to
                                            disclose
                                            it;
                                            or



 


		10.5.4.	isindependently developed by any employee, agent, officer, director,
auditor, adviser, partner, consultant, licensee, sublicensee, joint venturer or subcontractor of the Consultant who hod no access to the
Confidential Information and where the independent development con be proven by contemporaneous written documentation.
 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 7 of 29



     


    

 








		10.6.	Client
may inspect and copy Study
Subjects’
medical records
that might also include
information not
directly
connected
to a Study provided such information
will remain
confidential and will
not be
used
for any purpose other than
the confirmation of
the Study
Data. Consultant shall
and shall use
its best
endeavours
to ensure
that the
Investigators
shall not include
names or
personal identifiers that
could
lead to
the
identification
of the
Study Subjects in any
release of data, reports,
or publications
related to
a Study.



 


		10.7.	The
                                            Consultant
                                            shall have no
                                            publication
                                            rights whatsoever
                                            relating
                                            or
                                            arising
                                            from
                                            a
                                            Study
                                            or
                                            the
                                            Services
                                            performed under this
                                            Agreement,
                                            including without limitation,
                                            with
                                            respect
                                            to
                                            any
                                            Data or other Confidential
                                            Information.



 


		10.8.	Within
                                            thirty
                                            (30)
                                            days after termination
                                            or
                                            expiration
                                            of
                                            this
                                            Agreement,
                                            Consultant
                                            shall
                                            return
                                            to Client
                                            any document or
                                            other
                                            data
                                            carrier containing Client Confidential
                                            Information
                                            and
                                            Data including
                                            copies and
                                            shall
                                            destroy
                                            any electronic versions thereof,
                                            with
                                            the
                                            exception
                                            of
                                            those
                                            documents
                                            or other
                                            data
                                            that
                                            Consultant
                                            is
                                            entitled
                                            to or
                                            required
                                            to
                                            maintain in
                                            accordance
                                            with
                                            any
                                            Laws.



 


		11.	INTELLECTUAL
PROPERTY RIGHTS



 


		11.1.	The
                                            parties
                                            acknowledge that
                                            any
                                            Intellectual
                                            Property
                                            Rights developed, owned or
                                            licensed
                                            by
                                            a party prior to
                                            the
                                            effective
                                            date
                                            of
                                            an
                                            Appendix
                                            shall
                                            remain
                                            the
                                            property
                                            of that
                                            party.



 


		11.2.	The
                                            Client
                                            hereby
                                            grants to
                                            the
                                            Consultant
                                            until
                                            termination
                                            or
                                            expiry
                                            of
                                            this
                                            Agreement
                                            a
                                            royalty-free
                                            non-exclusive,
                                            non-transferable
                                            licence to
                                            use
                                            those
                                            parts
                                            of
                                            the
                                            Intellectual
                                            Property
                                            Rights owned or
                                            controlled
                                            by
                                            the
                                            Client
                                            which
                                            are wholly and
                                            necessarily
                                            required
                                            by the Consultant
                                            solely
                                            for the purpose of
                                            the
                                            provision
                                            of Services under this
                                            Agreement or
                                            an
                                            Appendix.



 


		11.3.	Subject
                                            to
                                            the
                                            Client complying
                                            with
                                            clause 6, all Intellectual
                                            Property
                                            Rights
                                            made, originated, developed, created or produced pursuant to
                                            the
                                            provision
                                            of
                                            the
                                            Services
                                            under
                                            this
                                            Agreement,
                                            shall
                                            belong
                                            to
                                            and
                                            vest automatically upon
                                            creation
                                            in
                                            the
                                            Client (“Client Intellectual
                                            Property
                                            Rights”).



 


		11.4.	To
the extent
the Consultant,
its
employees or
its
subcontractors
acquire
any rights
to the
Client
Intellectual
Property
Rights under
this Agreement,
the
Consultant shall,
and
shall
procure that
its
employees and its
subcontractors
shall,
at
the
Client’s
expense,
immediately
take all necessary
steps to
assign or
procure the
assignment
of all
right,
title and interest in
the Client
Intellectual
Property Rightsand
deliver these
to the Client
together
with all
rights of
action
and remedies in
relation
to those infringements.
The Client
acknowledges
that the
assignment shall
not restrict
the Consultant
from using
the skill,
know-how and
expertise acquired
in the
performance
of the Services
for the
purposes of
providing similar
services to
any
other
client.



 


		11.5.	The
Client
acknowledges
that the
Consultant
possesses certain inventions,
processes, technology, know-how, trade
secrets, improvements,
other
Intellectual
Property
Rights
and other assets including
those
related to composition
of matter,
data
collection,
data management processes, laboratory
analyses, analytical methods, procedures
and techniques,
computer technical
expertise
and software (including codes)
which have
been independently
developed without the
benefit
of
any information provided
by the
Client (“Consultant Property”)
and all
Consultant
Property isthe
property of
the Consultant
and the
Client
hasno
right, title or
interest
in that Consultant
Property.



 


		11.6. 	At
                                            the
                                            reasonable
                                            request
                                            and expense
                                            of
                                            the
                                            Client,
                                            the
                                            Consultant
                                            shall,
                                            and
                                            shall
                                            procure
                                            that its employees
                                            and
                                            subcontractors
                                            shall,
                                            provide
                                            all
                                            assistance
                                            necessary including
                                            the
                                            execution
                                            of documents
                                            and
                                            the
                                            supply
                                            of
                                            information
                                            in
                                            order
                                            to give effect to
                                            clauses
                                            11.3
                                            and 11.4 above.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 8 of 29



     


    

 


		12.	WARRANTY,
INDEMNITY,
LIMITATION
ON LIABILITY,
AND INSURANCE



 


		12.1.	The
                                                                                                                                                                                                                                                                                                                                                                                                          Consultant representsand
                                                                                                                                                                                                                                                                                                                                                                                                          warrants that,
                                                                                                                                                                                                                                                                                                                                                                                                          to the
                                                                                                                                                                                                                                                                                                                                                                                                          best of
                                                                                                                                                                                                                                                                                                                                                                                                          itsknowledge:
                                                                                                                                                                                                                                                                                                                                                                                                          (a) it and its
                                                                                                                                                                                                                                                                                                                                                                                                          subcontractors
                                                                                                                                                                                                                                                                                                                                                                                                          (including Investigators) have not
                                                                                                                                                                                                                                                                                                                                                                                                          been debarred,
                                                                                                                                                                                                                                                                                                                                                                                                          disqualified
                                                                                                                                                                                                                                                                                                                                                                                                          from practice,
                                                                                                                                                                                                                                                                                                                                                                                                          or banned
                                                                                                                                                                                                                                                                                                                                                                                                          from conducting
                                                                                                                                                                                                                                                                                                                                                                                                          clinical
                                                                                                                                                                                                                                                                                                                                                                                                          trials
                                                                                                                                                                                                                                                                                                                                                                                                          by any regulatory
                                                                                                                                                                                                                                                                                                                                                                                                          authority;
                                                                                                                                                                                                                                                                                                                                                                                                          and (b) it
                                                                                                                                                                                                                                                                                                                                                                                                          and its subcontractors
                                                                                                                                                                                                                                                                                                                                                                                                          (including Investigators)
                                                                                                                                                                                                                                                                                                                                                                                                          have not
                                                                                                                                                                                                                                                                                                                                                                                                          been convicted
                                                                                                                                                                                                                                                                                                                                                                                                          under any Laws
                                                                                                                                                                                                                                                                                                                                                                                                          for misconduct relating
                                                                                                                                                                                                                                                                                                                                                                                                          to the
                                                                                                                                                                                                                                                                                                                                                                                                          development
                                                                                                                                                                                                                                                                                                                                                                                                          or approval of
                                                                                                                                                                                                                                                                                                                                                                                                          any
                                                                                                                                                                                                                                                                                                                                                                                                          drug, biologic
                                                                                                                                                                                                                                                                                                                                                                                                          or medical device;
                                                                                                                                                                                                                                                                                                                                                                                                          or any application to
                                                                                                                                                                                                                                                                                                                                                                                                          conduct clinical
                                                                                                                                                                                                                                                                                                                                                                                                          trials;
                                                                                                                                                                                                                                                                                                                                                                                                          or any application for marketing
                                                                                                                                                                                                                                                                                                                                                                                                          approval of
                                                                                                                                                                                                                                                                                                                                                                                                          a drug,
                                                                                                                                                                                                                                                                                                                                                                                                          biologic
                                                                                                                                                                                                                                                                                                                                                                                                          or medical
                                                                                                                                                                                                                                                                                                                                                                                                          device.
                                                                                                                                                                                                                                                                                                                                                                                                          As soon as practicable
                                                                                                                                                                                                                                                                                                                                                                                                          after it becomes
                                                                                                                                                                                                                                                                                                                                                                                                          aware, Consultant shall
                                                                                                                                                                                                                                                                                                                                                                                                          notify
                                                                                                                                                                                                                                                                                                                                                                                                          Client
                                                                                                                                                                                                                                                                                                                                                                                                          of any
                                                                                                                                                                                                                                                                                                                                                                                                          debarment,
                                                                                                                                                                                                                                                                                                                                                                                                          disqualification or ban,
                                                                                                                                                                                                                                                                                                                                                                                                          or the
                                                                                                                                                                                                                                                                                                                                                                                                          commencement of
                                                                                                                                                                                                                                                                                                                                                                                                          any
                                                                                                                                                                                                                                                                                                                                                                                                          debarment or disqualification
                                                                                                                                                                                                                                                                                                                                                                                                          proceedings
                                                                                                                                                                                                                                                                                                                                                                                                          against Consultant or
                                                                                                                                                                                                                                                                                                                                                                                                          any of its
                                                                                                                                                                                                                                                                                                                                                                                                          subcontractors
                                                                                                                                                                                                                                                                                                                                                                                                          (including
                                                                                                                                                                                                                                                                                                                                                                                                          Investigators)
                                                                                                                                                                                                                                                                                                                                                                                                          or othersperforming
                                                                                                                                                                                                                                                                                                                                                                                                          Services hereunder.



 


		12.2.	Subject to Section 12.4, the Client shall indemnify the Consultant
(and its officers, directors, employees, consultants and sub-consultants) (together, “Consultant lndemnitees”) against all
third party costs, expenses (including legal fees and costs), claims, proceedings, losses or damages including claims made or brought
(whether successfully or otherwise) by or on behalf of Study Subjects (including their dependants and children injured in utero through
the participation of the child’s mother or father in a Study) for personal injury (including death) to Study Subjects (and children injured
in utero through the participation of the child’smother or father in a Study) arising out of or relating to the administratitn and/or
or use of an lnvestigational Product or any clinical intervention or procedur provided for or required by a Protocol to which the Study
Subjects would not have een exposed but for the participation of the Study Subjects in a Study (“Liabilities”) incurred or
suffered by or awarded against a Consultant lndemnitee in connection with this Agreement except to the extent caused by: (a) any negligence,
wrongful act, omission, breach of statutory duty of a Consultant lndemnitee; (b) conduct of a Consultant lndemnitee not in accordance
with the Protocol; or (c) conduct of a Consultant lndemnitee not in accordance with the terms and conditions of this Agreement and the
applicable Appendix, and all applicable Laws (the Liabilities described in paragraphs (a), (b) and (c), “Consultant Liabilities”).


 


		12.3.	Subject to Section 12.4, the Consultant shall indemnify the
Client (and its officers, directors, employees, agents, consultants and sub-consultants) (together, “Client lndemnitees”) against
all Consultant Liabilities incurred or suffered by or awarded against a Client lndemnitee in connection with this Agreement.



 


		12.4.	The parties shall provide each other with prompt notice of
any third party claim that may be subject to indemnification under this Agreement and they shall cooperate with each other in the defence
of such claims. Neither party shall be bound by any settlement of any claim unlesssuch party hasprovided itsprior written consent to
such settlement, such consent not to be unreasonably withheld.



 


		12.5.	During the Term of this Agreement and for a reasonable time
after the Term, where each party remains in operation, the Client and the Consultant shall each maintain insurance necessary to meeting
their liability obligationsunder this Agreement, as well as sufficient levels of all legally mandated insurance, including as a minimum,
commercial generalliability insurance, clinical trials insurance and professional liability insurance and shall provide each other upon
request, copies of the appropriate evidence of currency of such insurance.


 


		13.	RECORDSRETENTION



 


Consultant
shall
retain all
records,
documents,
materials
and Data related
to a Study (“Records”)
during
the
Term
hereof
and
for the
longer
of:
(a)
the period
of time
required
by applicable
laws
and
regulations;
and (b)
five (5) years after
the
date of expiration
or
termination
of
this
Agreement.
In any
event, Consultant
shall
not destroy any
Records without first notifying Client
in writing
and giving
Client the opportunity to retrieve
same at its own
expense.


 



    	InCannex & CNS MCA & App 1	25 June 2020	Page 9 of 29



     


    

 


		14.	REGULATORY;
AUDIT AND INSPECTIONS



 


		14.l.	If any Local Regulator requests access to or the right to inspect and
audit the Records or facilities of Consultant or any lnvestigational Site, Consultant shall promptly notify Client and cooperate with
Client in any response to such request, including giving the Local Regulator access and the right to inspect and audit such Records, facilities
or lnvestigational Site and, at Client’s election where reasonably possible, allowing Client to be present at such inspection and audit.
Consultant shall keep Client informed of the progress of any such access, inspection and audit, and provide Client with copies of those
documents that are furnished to any Local Regulator in the course of such access, inspection and audit.



 


		14.2.	Consultant
                                            shall permit
                                            Client
                                            or its
                                            designee,
                                            on reasonable advance notice
                                            to Consultant
                                            and during regular
                                            business hours and under
                                            conditions of confidentiality, to
                                            examine
                                            and audit: (a)
                                            all
                                            Records
                                            and
                                            all Data; and (b) Consultant’s facilities (including
                                            the facilities of
                                            Consultant’s subcontractors) where Services are performed.


 

		14.3.	If
                                            pursuant
                                            to any
                                            access,
                                            inspection
                                            or audit
                                            under this Section 14,
                                            any
                                            deficiencies
                                            are
                                            identified
                                            and
                                            notified
                                            to the Consultant
                                            in
                                            the
                                            Services, in
                                            any
                                            Records, in any Data, or in
                                            any
                                            facilities where Services are
                                            performed,
                                            or if
                                            any
                                            non-compliance with this
                                            Agreement
                                            is
                                            ascertained,
                                            the
                                            Consultant
                                            shall promptly correct such deficiencies or non-compliance at its sole expense.


 


		14.4.	Consultant shall promptly provide Client with copies of all written communications
with Local Regulators relating to the Services or a Study and with summaries of all oral communications with Local Regulators relating
to the Services or a Study. Consultant shall provide Client with any proposed response to any communication from a Local Regulator relating
to the Services or a Study, shall take into account Client’scomments with respect thereto, and shall provide Client with a copy of the
final response.



 


		15.	ASSIGNMENT



 


No
party may
assign its
obligations or rights
under this
Agreement without the
prior written consent of the
other party
except where the
assignment is to an Affiliate of
the assigning
party or to an
assignee of all or
substantially all of that assigning
party’s business (or
the portion
to which this Agreement
relates). The
assigning party will promptly
give notice
of such assignment
in writing to the
other party and the
assigning party will remain liable
for all of its
obligations contained in
this Agreement up to and
including date of assignment.


 


		16.	NOTICES



 


		16.l.	Any
notice,
approval, consent
or other communication in connection
with this Agreement must be in writing, and either hand-delivered,
email attachment or sent by express
air courier service to the
addressee set forth below:



 


If to Consultant: Clinical Network
Services (CNS) Pty Ltd Attention: Russell Neal


Managing Director


Level 2, 38l MacArthur Ave HAMILTON,


QLD 4007


Australia


Tel: +61(0)73719 6000


Email: russell.neal@clinical.net.au

 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 10 of 29



     


    

 


If
to Client:
InCannex
Pty Ltd


Attention:
Mr Glenn
Fowles


PO
Box 324,
Collins
Street
West,


Melbourne,


VIC
8007,


Australia


Tel:
[***]


Email:
[***]


 


		16.2.	The
address
of
a party
may
be changed by a party
on written
notice
to
the
other party.



 


		16.3.	Any
                                                                                                                                                                                      notice,
                                                                                                                                                                                      approval, consent
                                                                                                                                                                                      or other communication made
                                                                                                                                                                                      shall be
                                                                                                                                                                                      deemed to have been received
                                                                                                                                                                                      upon delivery
                                                                                                                                                                                      in the
                                                                                                                                                                                      event of
                                                                                                                                                                                      hand delivery
                                                                                                                                                                                      or delivery by
                                                                                                                                                                                      air courier.
                                                                                                                                                                                      In the case of
                                                                                                                                                                                      notice by
                                                                                                                                                                                      email attachment,
                                                                                                                                                                                      delivery
                                                                                                                                                                                      shall be
                                                                                                                                                                                      deemed effective upon
                                                                                                                                                                                      receipt by the
                                                                                                                                                                                      sender of confirmed
                                                                                                                                                                                      answer-back by the recipient. All
                                                                                                                                                                                      noticesshall be
                                                                                                                                                                                      given
                                                                                                                                                                                      by one
                                                                                                                                                                                      party to the
                                                                                                                                                                                      other party in the English language
                                                                                                                                                                                      and must be
                                                                                                                                                                                      signed
                                                                                                                                                                                      by an authorised
                                                                                                                                                                                      officer of
                                                                                                                                                                                      the party giving the notice,
                                                                                                                                                                                      or (on its
                                                                                                                                                                                      behalf}
                                                                                                                                                                                      by any solicitor,
                                                                                                                                                                                      director,
                                                                                                                                                                                      secretary
                                                                                                                                                                                      or authorised
                                                                                                                                                                                      agent of
                                                                                                                                                                                      that party.



 


		17.	FORCE
MAJEURE



 


		17.1. 	If any
                                                                                                                                                party
                                                                                                                                                is unable to
                                                                                                                                                carry
                                                                                                                                                out itsobligationsunder this
                                                                                                                                                Agreement
                                                                                                                                                by reason of any
                                                                                                                                                act of God.
                                                                                                                                                strike, lockout,
                                                                                                                                                or other
                                                                                                                                                industrial disturbance,
                                                                                                                                                act of public
                                                                                                                                                enemy, war, blockade, public
                                                                                                                                                riot, lightning,
                                                                                                                                                fire, storm,
                                                                                                                                                flood,
                                                                                                                                                earthquake,
                                                                                                                                                explosion,
                                                                                                                                                governmental restraint,
                                                                                                                                                or any
                                                                                                                                                other event whether
                                                                                                                                                of the kind
                                                                                                                                                specifically
                                                                                                                                                enumerated
                                                                                                                                                above
                                                                                                                                                or otherwise
                                                                                                                                                which is not
                                                                                                                                                reasonably
                                                                                                                                                within the
                                                                                                                                                control of
                                                                                                                                                a party relying
                                                                                                                                                on that event
                                                                                                                                                (“Force
                                                                                                                                                Majeure
                                                                                                                                                Event”),
                                                                                                                                                that party must give the
                                                                                                                                                other party
                                                                                                                                                prompt
                                                                                                                                                written notice
                                                                                                                                                of the Force
                                                                                                                                                Majeure Event with reasonably
                                                                                                                                                full particulars
                                                                                                                                                concerning it.



 


		17.2.	After
a party
has given notice
of a
Force
Majeure
Event,
the obligations
of that
party,
so far
as they are
affected
by the
Force
Majeure
Event,
are suspended
during
the
continuance
of the
Force
Majeure
Event and
neither
party is
liable
for any
delay
or failure
to perform
its
obligationsunder
this
Agreement
if
the
delay
or failure
is
due
to a Force
Majeure
Event.



 


		17.3.	As
                                                                                                                                                                                                        soon as
                                                                                                                                                                                                        practicable
                                                                                                                                                                                                        following
                                                                                                                                                                                                        such notification, the
                                                                                                                                                                                                        parties will consult with each
                                                                                                                                                                                                        other
                                                                                                                                                                                                        in good faith and use
                                                                                                                                                                                                        all reasonable
                                                                                                                                                                                                        endeavours to
                                                                                                                                                                                                        agree
                                                                                                                                                                                                        appropriate terms to mitigate the
                                                                                                                                                                                                        effects
                                                                                                                                                                                                        of the Force
                                                                                                                                                                                                        Majeure
                                                                                                                                                                                                        Event and facilitate the
                                                                                                                                                                                                        continued performance
                                                                                                                                                                                                        of the
                                                                                                                                                                                                        Agreement. An affected
                                                                                                                                                                                                        party must
                                                                                                                                                                                                        use itsbest efforts
                                                                                                                                                                                                        to remove the Force
                                                                                                                                                                                                        Majeure
                                                                                                                                                                                                        Event as
                                                                                                                                                                                                        quickly
                                                                                                                                                                                                        as possible.



 


		17.4.	If
                                            a
                                            delay
                                            or failure
                                            by a party to
                                            perform
                                            its
                                            obligations
                                            due to
                                            Force Majeure
                                            Event
                                            exceeds
                                            30 days, either
                                            party
                                            may immediately
                                            terminate
                                            this
                                            Agreement
                                            on providing
                                            notice
                                            in writing
                                            to
                                            the
                                            other
                                            party.



 


		18.	APPLICABLE
                                            LAW AND
                                            JURISDICTION



 


		18.1.	This Agreement
and the transactionscontemplated by it are governed by the lawsof Queensland, Australia and the parties hereby submit to the non-exclusive
jurisdiction of the courtsin Queensland, Australia.



 


		19.	MISCELLANEOUS



 


		19.1.	Exercise
                                            of
                                            Rights:
                                            A party
                                            to
                                            this
                                            Agreement
                                            may
                                            exercise
                                            a right,
                                            power
                                            or
                                            remedy
                                            at
                                            its
                                            discretion
                                            and
                                            separately
                                            or concurrently
                                            with
                                            another
                                            right.
                                            power
                                            or
                                            remedy.
                                            A
                                            single
                                            or partial
                                            exercise
                                            of
                                            a
                                            right, power or
                                            remedy
                                            of
                                            a
                                            party does not prevent
                                            a
                                            further
                                            exercise
                                            of
                                            that
                                            or of
                                            any
                                            other
                                            right,
                                            power or remedy.
                                            Failure
                                            by a party
                                            to exercise
                                            or
                                            delay
                                            in
                                            exercise
                                            a right,
                                            power
                                            or
                                            remedy
                                            does
                                            not
                                            prevent
                                            its
                                            exercise.



 


		19.2.	Publicity:
                                            Consultant shall not
                                            use
                                            Client’s name
                                            publicly
                                            or in
                                            connection
                                            with any publication without Client’s prior
                                            written
                                            consent, nor shall Consultant make any public
                                            announcements concerning this Agreement or any Study.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 11 of 29



     


    

 


		19.3.	Waiver:
                                            A provision of or right created
                                            by
                                            this Agreement may not
                                            be
                                            waived except in writing signed
                                            by
                                            the
                                            party granting the waiver.



 


		19.4.	Approvals
                                            and Consent: A
                                            party to this Agreement
                                            may
                                            give
                                            conditionally
                                            or
                                            unconditionally or withhold its
                                            approval
                                            or consent in
                                            its
                                            absolute discretion unless this Agreement expressly provides otherwise.



 


		19.5.	Remedies
                                            Cumulative: The
                                            rights,
                                            powers and remedies
                                            provided
                                            under this Agreement are cumulative with and not
                                            exclusive
                                            of the
                                            rights, powers
                                            or remedies
                                            provided
                                            by
                                            law or
                                            in equity independently
                                            of
                                            this
                                            Agreement.



 


		19.6.	Further
                                            Assurances:
                                            Each party to
                                            this Agreement
                                            agrees at its
                                            own
                                            expense, on the
                                            request of
                                            the other party, to
                                            do
                                            everything reasonably necessary to give effect
                                            to
                                            the Agreement
                                            and the
                                            transactions contemplated
                                            by
                                            it
                                            (including the
                                            execution
                                            of documents) and to
                                            use
                                            all reasonable
                                            endeavours
                                            to cause relevant
                                            third
                                            parties
                                            to do otherwise.



 


		19.7.	Severability:
                                            Whenever possible, each provision of
                                            this Agreement
                                            shall be interpreted
                                            in such
                                            manner
                                            as
                                            to
                                            be
                                            effective and valid under
                                            applicable
                                            laws
                                            and
                                            regulations,
                                            but
                                            if
                                            any
                                            provision of this
                                            Agreement
                                            is
                                            held to
                                            be prohibited by or
                                            invalid
                                            under
                                            applicable laws
                                            or
                                            regulations,
                                            such
                                            provision shall be ineffective only to
                                            the extent
                                            of such prohibition or invalidity,
                                            without
                                            invalidating
                                            the remainder
                                            of this Agreement. In
                                            the
                                            event of such invalidity,
                                            the parties
                                            shall endeavour in
                                            good
                                            faith
                                            to agree
                                            on an alternative enforceable provision that
                                            preserves
                                            the
                                            original
                                            purpose of this Agreement.



 


		19.8.	Entire
                                            Agreement: This Agreement and the
                                            Appendices
                                            attached hereto
                                            [i.e., the Appendix(s)
                                            and SOW(s)) constitute and contain the
                                            complete,
                                            final
                                            and
                                            exclusive understanding and agreement of the
                                            parties,
                                            and cancel and
                                            supersede
                                            any and all prior negotiations, correspondence, understandings and agreements, whether oral
                                            or written, between them
                                            respecting
                                            the subject matter hereof.



 


		19.9.	Counterparts:
                                            This Agreement may be signed and delivered in two
                                            or
                                            more counterparts each of which shall be deemed an original but all of which together
                                            will
                                            constitute one and the same instrument
                                            and may
                                            be
                                            signed
                                            and delivered through
                                            the
                                            use
                                            of
                                            facsimile.



 


[SIGNATURES
APPEAR ON NEXT PAGE]


 




    	InCannex & CNS MCA & App 1	25 June 2020	Page 12 of 29



     


    

 


This
Master Consulting Agreement is EXECUTED as
an agreement.


 


	
	EXECUTED by an authorised
    signatory of InCannex Pty Ltd	 
	 	 
	/s/ Joel Latham	 
	Signature of Company Signatory	 
	 	 
	Joel Latham	 
	Name of Company Signatory	 
	 	 
	Managing Director	 
	Title of Company Signatory	 
	 	 
	29.6.20	 
	Date	 
	 	 
	EXECUTED by an authorised signatory of CLINICAL
    NETWORK SERVICES (CNS) PTY LTD	 
	 	 
	/s/ Russell
    Neal	 
		 
	Russell Neal	 
	Name of Company Signatory	 
	 	 
	Managing Director	 
	Title of Company Signatory	 


 




    	InCannex & CNS MCA & App 1	25 June 2020	Page 13 of 29



     


    

 


APPENDIX
1


 


		1	INTRODUCTION



 


THIS
Appendix
l to
MCA (25
June
2020),
by
and
between
InCannex
Pty
Ltd and
Clinical
Network
Services
(CNS)
Pty
Ltd,
is
made
effective
on 25
June 2020 and has
been
developed
based upon
Protocol
synopsis entitled:


 


A
randomised crossover study in Subjects with suspected or diagnosed mild to moderate Obstructive Sleep
Apnoea (OSA).


 


		2	PROJECT
                                            ASSUMPTIONS AND SCOPE OF WORK



 


General


 


		l)	The
                                                                                                                                                                                                     study will
                                                                                                                                                                                                     be conducted in
                                                                                                                                                                                                     strict accordance
                                                                                                                                                                                                     with the Protocol,
                                                                                                                                                                                                     the quality
                                                                                                                                                                                                     practices
                                                                                                                                                                                                     as detailed
                                                                                                                                                                                                     in ICH GCP,
                                                                                                                                                                                                     and
                                                                                                                                                                                                     Australian
                                                                                                                                                                                                     regulations
                                                                                                                                                                                                     detailed in its
                                                                                                                                                                                                     document “Integrated
                                                                                                                                                                                                     Addendum
                                                                                                                                                                                                     to ICH
                                                                                                                                                                                                     E6(Rl ): Guideline for
                                                                                                                                                                                                     Good Clinical
                                                                                                                                                                                                     Practice ICH E6(R2)
                                                                                                                                                                                                     - Annotated
                                                                                                                                                                                                     with Therapeutic
                                                                                                                                                                                                     Goods Administration (TGA) comments
                                                                                                                                                                                                     as below, 25
                                                                                                                                                                                                     June
                                                                                                                                                                                                     2018”, the DIA TMFReference
                                                                                                                                                                                                     Model as
                                                                                                                                                                                                     well as the
                                                                                                                                                                                                     current Declaration
                                                                                                                                                                                                     of Helsinki,
                                                                                                                                                                                                     collectively
                                                                                                                                                                                                     referred to hereafter as
                                                                                                                                                                                                     “GCP standards”.



 


		2)	CNSwill archive their
                                                                                                                                                                                                     own records
                                                                                                                                                                                                     for a period
                                                                                                                                                                                                     determined
                                                                                                                                                                                                     by GCPstandards
                                                                                                                                                                                                     and/or local Australian regulations
                                                                                                                                                                                                     as applicable. All other
                                                                                                                                                                                                     original
                                                                                                                                                                                                     files and records including
                                                                                                                                                                                                     a GCP standard electronic Trial
                                                                                                                                                                                                     Master File (eTMF) will
                                                                                                                                                                                                     be returned
                                                                                                                                                                                                     to InCannex
                                                                                                                                                                                                     at the
                                                                                                                                                                                                     conclusion of
                                                                                                                                                                                                     the study.
                                                                                                                                                                                                     The TMF
                                                                                                                                                                                                     will contain
                                                                                                                                                                                                     completed
                                                                                                                                                                                                     sections
                                                                                                                                                                                                     for which CNS are
                                                                                                                                                                                                     directly
                                                                                                                                                                                                     responsible. Vendors
                                                                                                                                                                                                     and sites
                                                                                                                                                                                                     that are not
                                                                                                                                                                                                     managed by CNS
                                                                                                                                                                                                     may not be included
                                                                                                                                                                                                     unless otherwise agreed upon
                                                                                                                                                                                                     by InCannex
                                                                                                                                                                                                     and N CNS.



 


		3)	CNS willutilise SureClinical as the cloud-based eTMFfor this
study, as they are FDA Part 11 and European Commission Annex 11 compliant. SureClinical will enable lnCannex to securely acquire, view,
share and manage clinical trial electronic content in the trial master files including those from other vendors, as well as, those related
to the site. SureClinical ensures that study documents, medical images and eRecords are always available to all stakeholders, even when
offline. CNS will be responsible for ensuring that the Investigator and/or study coordinator maintainsand updatesthe regulatory files
at the site. At each interim monitoring visit and close-out visit the site file will be reviewed for consistency with the eTMF maintained
by CNS.



 


		4)	CNS will ensure all required documents and records are included in the TMF throughout
the study and will provide a final review for completeness at the conclusion of the study. The complete TMF, inclusive of final CRFdata
and statistical outputson digital media is the final deliverable in thisproject.



 


		5)	CNSuses Oracle Siebel®Clinical Trial Management System (CTMS) and can either
provide direct access for lnCannex to the reportsmodule of thissystem, or forward reports to your team for review on a regular basis (e.g.
along with the agenda of the regular team calls).Oracle Siebel®provides visibility and access to: site start up status, site contractsand
budgets, ethics committee submissions and approvals, patient enrolment, monitoring visit reports, frequently asked questions, protocol
deviations, accessible reports that can be sent to lnCannex weekly and ad hoc and tracks timelines and key project deliverables.


 


Lead-In
and Operational Project Kick-off


 


		6)	CNSwill
appropriately
resource
the
Project
Team
according
to
servicesrequired,
led by a PM.
Upon
contract
award,
the
CNS
PM will immediately
arrange
a kick-off
call
with
InCannex’s
PM to
review
the
scope and
timelines
and
identify
any areas for clarification.



 


		7)	Clinical
                                            and
                                            Biometrics
                                            activities
                                            will
                                            need
                                            to commence
                                            once the
                                            contract
                                            is
                                            signed
                                            and
                                            therefore
                                            an operationally
                                            focussed
                                            project
                                            kick-off
                                            meeting
                                            will
                                            be
                                            held
                                            with
                                            all
                                            relevant
                                            members
                                            of
                                            the
                                            Project
                                            Team
                                            and
                                            InCannex.
                                            At
                                            this
                                            meeting,
                                            the
                                            CNS
                                            PM
                                            will
                                            lead
                                            discussion
                                            to
                                            provide
                                            all
                                            team
                                            members
                                            with
                                            an
                                            understanding
                                            of
                                            the
                                            trial
                                            aims,
                                            timelines
                                            and
                                            expectations
                                            of all
                                            deliverables
                                            to
                                            InCannex.






 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 14 of 29



     


    

 


		8)	The
                                            Project Team
                                            will
                                            include
                                            a Clinical
                                            Research
                                            Associate
                                            (CRA),
                                            Data
                                            Manager,
                                            Biostatistician,
                                            Medical
                                            Writer,
                                            Medical
                                            Monitor
                                            and
                                            a
                                            Project
                                            Administrator
                                            (PA).



 


		9)	Project Team members will review and familiarise themselves with the relevant project
materialsas soon asrequired dutiesdictate. The PM will manage interaction of the required Project Team members with lnCannex throughout
the project.


 


Investigator
Brochure (1B) Development


 


		10)	InCannex
                                                                                                                                                                                                      will provide
                                                                                                                                                                                                      CNSwith an ICH-GCP compliant Investigator’s Brochure.



 


Protocol
Development


 


		11)
	InCannex
             will provide
             CNSwith an ICH-GCP compliant
             Study Protocol.



 


Site
Identification and Selection


 


		12)	InCannex will identify an lnvestigational Site to perform the proposed study. It
is assumed that lnCannex have performed appropriate assessments of the site’s suitability and capabilities to conduct thisstudy. Whilst
not included in this Appendix, CNScan perform a Site Selection Visit (SSV) upon request.


 


Clinical
Services


 


		13)	Following confirmation of the site and finalisation of the protocol, CNS initiate
Data Management activities (See below).



 


		14)	lnCannex will assist lnvestigational Site with preparation of submission packages
to their Human Research Ethics Committee (HREC) including the development and approval of compliant PIC/F and any other patient materials,
including all patient assessment materials, advertising etc. It is assumed that a diary card isnot applicable to thisstudy but should
one be utilised, lnCannex will advise CNSso suitable solutionsmay be discussed and added to future iterationsof this Appendix.



 


		15)	lnCannex will co-ordinate and manage the Clinical Trial Research Agreement (CTRA)
with lnvestigational Site including paymentsto lnvestigational Site.



 


		16)	An Investigator Meeting is not considered necessary for thisstudy and isnot included
in this Appendix.



 


		17)	CNS will collect necessary regulatory documents and will establish and maintain
applicable filing systems in compliance with GCP standards.



 


		18)	Following receipt of HREC approval and acknowledgement of the clinical trial notification
(CTN) from the TGA, CNS will perform a Site Initiation Visit [SIV) to prepare for commencement of the study and will review final logistical
considerations, lnvestigational Product (IP), Protocol, CRF training, SAE reporting and GCP training. CNS PM may accompany the CRA for
thisvisit to ensure all final logistical mattersare reviewed, however, these costs are not included in the Appendix at this time.



 


		19)	A total of eleven ( 11) days monitoring has been calculated as required
to monitor/ source data verify (SDV) 100% subject CRFs against 100% of data points as well as an appropriate regime to ensure timely review
of data, minimisation of data cleaning bottlenecks and identify issues/resolution during the study.



 


		a.	A 3-day monitoring visit every three weeks’ during the course of the study (3 visits)



 


		b.	A 2-day monitoring visit following last subject last visit to complete all data queries
in preparation for database lock




 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 15 of 29



     


    

 


		c.	This plan would result in six (6) monitoring visit reportsbeing generated



 


		d.	The final monitoring visit schedule will be agreed with lnCannex and documented in
the study Project Management Plan.



 


		20)	At every visit, the CNS CRA will perform the following tasks:



 


		e.	Meet with key site staff to discuss the progress of the study;



 


		f.	Identify any unreported SAEs and implement appropriate reporting tasks;



 


		g.	Assess study conduct and data recording compliance against the current approved protocol
and log all protocol deviations;



 


		h.	Review CRF data against Source Data for l
00% of data points and informed consent for l 00% of Participants;



 


		i.	Screen failures will not be reviewed other than consent and
reason for failure;



 


		j.	Review IP storage and accountability



 


		k.	Ensure currency of Investigator oversight of the study, site contracted vendors and
site study team



 


		I.	Review the Investigator Site File for completeness and collect any updated documents,
and;



 


		m.	Document and seek corrective action for all discrepancies
and findings.



 


		21)	CNSwill perform a study closure site visit of 1-day (8 hour) duration upon advice
from Data Management that the study database is locked. This ensures completion of all GCP standard required activities and archiving
of associated documentation.



 


		22)	CNS will prepare a visit report, and following internal review, each final report
will be submitted to lnCannex within fifteen (15) working days of the last day of site visit.



 


		23)	Any visitsof any type required in addition to this will be charged on a “fee
for service” basis following written approval from lnCannex.



 


		24)	CNS will perform in-house site management activities as required throughout the
study, including:



 


		a.	Tracking screening and enrolment



 


		b.	eCRF completion guidance



 


		c.	Resolution of eData Queries



 


		d.	CTMS management



 


		e.	eTMF Maintenance



 


Regulatory


 


		25)	lnCannex will act as the local Sponsor in Australia for the active period of the study.
As local Sponsor lnCannex will act as required under regulatory authority rules of the TGA and will be responsible for the following:



 


		a.	Review of product labelling to ensure local compliance of all inner and outer product
packaging.



 


		b.	lnCannex will maintain suitable study insurance compliant with country requirements
and will have CNS as additionally insured.



 


		c.	Complete/sign necessary regulatory submission documents.



 


		d.	Complete/sign and maintain study indemnification.



  


		e.	Report
                                            any SAEs
                                            that
                                            are determined to
                                            be
                                            unexpected and related
                                            to
                                            the IP
                                            (or comparators), termed SUSARs,
                                            to
                                            the local
                                            regulatory
                                            authority.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 16 of 29



     


    

 


		26)	In Australia, the protocol will be submitted for regulatory acknowledgement only
via the Australian CTN scheme.



 


		27)	CNS SOPs will be used in the conduct of all activities performed by CNS unless
otherwise requested by lnCannex and following training of applicable CNS staff by lnCannex on lnCannex SOPs. The CNS PM will ensure currency
of training in applicable SOPs is maintained throughout the project.



 


		28)	lnCannex will be responsible for registering the study on a Clinical Trial Register
in accordance with local regulations.



 


		29)	CNS will monitor investigators responsibilities for the Periodic Safety and Annual
Reporting requirements to their applicable HREC and will support the site in their preparations in meeting such requirements. CNS will
obtain relevant Safety Information from lnCannex in order to comply with HREC and Regulatory Authority requirements for ongoing and study
completion advice.



 


Safety Laboratory


 


		30)	It is assumed lnvestigational Site will contract and manage their preferred pathology
laboratory to provide safety pathology testing required per protocol. The lnvestigational Site’s Pl will be responsible for their preferred
laboratory, which in turn will be responsible for appropriate sample labelling according to local practices.



 


		31)	CNS will review accreditation of the preferred laboratory during study start up,
collect relevant accreditation and normal range documentation during the essential document collection process after site selection, confirming
correct filing in the TMF and Investigator Site File at the SIV.



 


		32)	CNS will check to ensure currency of all laboratory documentation during monitoring
visits and collect updated documents as available.



 


		33)	CNS will review laboratory sampleshandling and co-ordination throughout the study.



 


		34)	CNS Data Manager will establish a Laboratory Data Transfer Agreement (LDTA) with
the responsible laboratory for transfer and upload of the safety lab data into CNS systems. Following a test run, data will be transferred
to CNS as per the agreed frequency in the LDTA considering protocol specific requirementsincluding dose escalation data package compilation
and data review requirements.



 


		35)	Upon request, CNScan be responsible for the sourcing, contracting and management
of the safety laboratory. Updated scope and costs will be provided in further versions of this Appendix.



 


Bioanalytical


 


		36)	Selected Bioanalytical Laboratory will provide Bioanalytical services. lnCannex
will directly contract and manage the Bioanalytical Vendor and will ensure that lnvestigational Site receive appropriate manuals and instructions
for both processing and shipments prior to the study enrolment.



 


		37)	Following analysis, Selected Bioanalytical Laboratory will report raw data to
the CNS Data Management team for inclusion in the study database for further analysis as required.



 


		38)	CNSBiometrics’ team will establish required Data Transfer Agreements with the
laboratory as necessary.



 


lnvestigational Product (IP) Management


 


		39)	lnCannex will be fully responsible for the packaging and labelling of IMP.



 


		40)	lnCannex will prepare a Pharmacy Manual and CNS willperform local review
and make comment as necessary.



 


		41)	InCannex
                                                                                                                                                                                                      will manage
                                                                                                                                                                                                      shipment of IPdirectly to Investigational Site.



 


		42)	CNSwill assist in the
                                                                                                                                                                                                      co-ordination
                                                                                                                                                                                                      of return
                                                                                                                                                                                                      of used/unused IPto InCannex
                                                                                                                                                                                                      per InCannex’s
                                                                                                                                                                                                      requirements.



 



    	InCannex & CNS MCA & App 1	25 June 2020	Page 17 of 29



     


    

 


Safety Management


 


		43)	A Safety Monitoring Committee (SMC) is not considered necessary for this study.



 


Medical Monitoring


 


		44)	CNS be responsible for local Medical Monitoring (MM) via a qualified, experienced
medically licensed Doctor. CNS MM will join the initial team kick-off meeting with the PM and lnCannex team to confirm service expectations
and timeline



 


		45)	The MM will be available 24/7 over the period of participant recruitment, treatment
and follow up for medical support of the study inclusive of medical review of:



 


		a.	Inclusion/exclusion queries from site



 


		b.	Planned protocol deviations



 


		c.	Safety issues arising in the study



 


		d.	SAE reports and related narrative preparation, as required



 


		e.	The final study safety database



 


		46)	After protocol finalisation and prior to the first SIV, a MM Kick Off Meeting
will be arranged between the CNS MM and lnCannex Medical Officer to confirm expectations of the local MMsupport required throughout the
study. At thismeeting a schedule of further meetings, status reports or other contact requirements will be agreed. Thereafter, the MM
and lnCannex Medical Officer will maintain contact as required for management of any safety matters as they arise in the study.



 


		47)	During the study start-up, the MM will be given access and training to the study
databases EDC and Laboratory to ensure the MM can provide review of all safety data in real time and with available context data for the
subjects.



 


		48)	The CNS MM will perform a review of medical coded terms during the study. The MM
can provide a final medical coding review on behalf of lnCannex prior to database lock if requested: however, this has not been included
at this time.



 


		49)	MM time has been costed as follows:



 


		●	Unit cost for familiarisation, Kick Off Meeting, protocol review and CSR review/input.



 


		●	A fixed retainer of five (5) hours each month during the 24/7 availability periods
of the study. If greater than 5 hoursisrequired in a given month, CNS will bill hours as incurred (Timesheet costs) with the agreement
of lnCannex.



 


		●	Hours as incurred each month during the 24/7 availability
periods of the study.



 


Project Management


 


		50)	Overall project management willbe provided by CNS PM noting that as lnCannex
will be responsible for start-up activities related to site selection, HREC approvals and CTN submissions, initial CNS PM role will be
limited to regular communication and development of the eCRF and other Biometrics functions.



 


		51)	CNS’s PM will maintain regular communications with lnCannex as required by telephone
and email. Key activitiesperformed by the CNSPM include:



 


		a.	Review and management of CNS budget and project resourcing.



 


		b.	Adherence to Project Timelines.



 


		c.	Provide
                                            overall
                                            Project
                                            Team
                                            leadership
                                            and liaise
                                            with
                                            InCannex
                                            Project
                                            Team
                                            on
                                            a
                                            regular
                                            basis.


 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 18 of 29



     


    

 


		d.	Ensure frequent and effective communication within the CNS Project Team, with lnCannex
Project Team and with lnvestigational Site.



 


		e.	Participation in all teleconferences with lnCannex and lead internal meetings
throughout the course of the project.



 


		f.	Maintain written documentation of all project correspondence including regular
sponsor meetings.



 


		g.	Collate and review IP Release Packages.



 


		h.	Develop the overall Project Management Plan, Safety Plan, Review of Pharmacy Manual.
CNS assumes that lnCannex will review and comment on final version of each and have costed for one round of review only. Project specific
documents are developed asan adjunct to CNSSOP’s.



 


		i.	Manage prompt resolution of identified problemswith appropriate team members,
including timely issue escalation to lnCannex. PM will identify potential problems/issues and provide lnCannex with recommended solutions
on a proactive basis.



 


		j.	Identification of areas of project risk, mitigation and escalation as required
in conjunction with the project team.



 


		k.	Ensure that proper SOPs are followed and that trial documentation is consistent,
complete, and correct.



 


		I.	Provide review of all key documents/deliverables in the trial for e.g. the eCRF,
Data Management Plan, Randomisation Plan, Statistical Analysis Plan and CSR.



 


		m.	Training of new CNSstaff and ongoing training for CNS team
where contracted.



 


		52)	Teleconferences will be held between lnCannex and CNSProject Team. Teleconferences
are estimated to be of one-hour duration and held weekly throughout the stud. Agenda and minutes will be prepared by CNSPM and circulated.



 


		53)	Additional meetings may be requested by lnCannex either face to face or by telephone.
These meetings will be invoiced at timesheet costs {hours as incurred) for required attendees with prior approval of lnCannex.



 


		54)	Formal status reports may also be provided upon reques1 but are not included in
this Appendix as it is anticipated that regular teleconferences and other communication will suffice



 


Data Management


 


		55)	It has been assumed Medidata Rave will be the EDC platform for thisstudy.



 


		56)	Data Management will be provided by CNS’sData Management team based in Australia.
CNS Data Manager will join the initial team kick-off meeting with the PM and lnCannex team to confirm service expectations and timelines.
In addition, the Data Manager will work with the PM and lnCannex team to clarify lnCannex’s requirements in terms of CRF/Database specifications
and expectations with respect to lnCannex team’s involvement in the Data Management process.



 



    	InCannex & CNS MCA & App 1	25 June 2020	Page 19 of 29



     


    

 


		57)	It has been assumed that a subject diary isnot required. However, should one be
required, CNS can support ePRO/eDiary allowsfor the safe and secure collection of patient reported outcomes and Electronic Clinical outcome
assessments (eCOA) data directly from patients through multiple platforms using handheld devices such as tablets, smart phones etc. This
service is not included in this Appendix but may be included upon request.


 


		58)	For studies with a substantial number of sites and patients, online randomisation
and trial supply management is a seriousoption that needs to be considered, i.e. the benefits may outweigh your direct and indirect costs,
and risks. For studies with a few sites and low number of patients, manual randomisation and supply management usually is more cost effective
at acceptable risk.


 


		59)	CNS deploys a library of CRF pages with variables (questions) and code lists (optional
answers) being compliant with CDASH (CDISC) conventions including variables and code lists required or expected by regulators like the
FDA. The regulatory requirements concerning variables and code lists that need to be collected influence the number of unique pages and
edit checks. CNS strongly recommends using these CDASH compliant CRF pages unchanged as SDTM compliant datasets will need to be submitted
to the regulators.



 


		60)	eCRF/DB costs are based on CNS using its library of CDASH compliant CRFs for assessments
except for those assessments that are unique to the protocol and not in the CRF library. Deviating from the standard CRFs might incur
costs. At the time of this Appendix, CNS has assumed 200 CRF pages and 400 edit checks. These estimates will be updated upon finalisation
of the protocol.



 


		61)	lnCannex will be involved in reviewing the CRF/Database; following a CRF screen
review session with client the database will be updated and the annotated CRF presented to lnCannex for sign off thus confirming the specifications
of the CRF/Database. Further changes after client sign-off of the annotated CRF will incur costs for implementing and testing the additional
changes. If so, a new annotated CRF will be presented for sign-off to client prior to Go Live of the CRF/Database.



 


		62)	A Data Management Plan (DMP) will be developed in compliance will Good Data Management
Practices (GDMP), updated as required and forwarded to lnCannex for review. This document will determine all Data Management activities.
In addition, a Data Review Plan will be developed addressing data consistency checks that cannot be addressed via edit checks.



 


		63)	CNS will work closely with Medidata Rave and lnvestigational Site in the design
of an electronic, online CRF/Database (eCRF/DB), inclusive of edit checks.



 


		64)	User Acceptance Testing (UAT) will be undertaken of the final draft eCRF in order
to test and confirm expected performance of the system prior to finalisation and being released as final. Any issues found will be rectified
prior to eCRF release. There will be no additional charges for required/requested additional screens or checks prior to launch of eCRF
(release for use).



 


		65)	This database will be maintained by CNS until the PM confirms that the database
can be decommissioned after submission of the second version of the tables, figures and listings (TFLs), unless agreed otherwise.



 


		66)	Prior to or around the SIV, all users of the eCRF at the site, at CNS and, if desired,
at lnCannex will need to have completed their training in the use of the eCRF system. CNS also provide eCRF Completion Guidelines for
use at the site.



 


		67)	Following training, user accounts will be activated for the users at lnvestigational
Site, the CNS clinical team, and if desired for lnCannex. Over the course of the study, all eCRF users (site and clinical teams) have
access to 24/7 helpdesk support.



 


		68)	All Adverse Events and Medical History medical verbatim terms will be coded using
the Medical Dictionary for Regulatory activities (MedDRA). lnCannex will be required to source and hold a (limited) MedDRA licence per
MedDRA licensing requirements. Please note CNS is unable to oversee MedDRA licencing on behalf of the client due to MedDRA’s own policy.



 


		69)	Concomitant medications will be coded using WHO Drug Global unless indicated otherwise
by lnCannex. lnCannex will be required to hold a WHO Drug Global licence per WHO-Drug Global licensing requirements.



 


		70)	Pathology/Bioanalytical data will be transferred in electronic format directly
by the laboratories to CNS or if applicable directly entered into the eCRF by site staff. The Electronic Data Transfer process (EDT) of
laboratory data will be described in the LDTA. A separate LDTA will be agreed for each laboratory and each type of laboratory dataset.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 20 of 29



     


    

 


		71)	Should lnCannex determine the need for additional applications and services for
the project, for example, an online randomisation system, trial supply management system, or imaging system, CNScan support these. Any
additional costs, both professional feesand application services fees, will be provided in further versions of this Appendix.



 


		72)	The costs for review of CRF data and reconciliation of CRF data with third party
data (e.g. safety laboratory data, PK data), are based on the available protocol (synopsis) details at the time of contracting and CNS
best practices. If changes to the scope and nature of data being collected, the visit-event structure, or other changes that impact the
data review time, CNS will contact lnCannex to discuss the cost implications of the budgeted versus the true data review time required.



 


		73)	The cost does not include data exports of the raw data for lnCannex’sperusal.



 


		74)	Edit checks will be programmed in the eCRF. These include missing data, ranges,
consistency checksbetween visitsetc. The Data Review Plan will also list all manual queries such as reconciliation of AEs, ConMeds, checking
of protocol deviations, etc.



 


		75)	Once all requirements for hard locking the database have been met, the database will
be hard-locked and data exported for analysis to the Biostatistics team.



 


Biostatistics


 


		76)	Biostatistical support to the study will be provided by CNS’s Biostatistics team
based in Australia. CNS Biostatistician will join the initial team kick-off meeting with the PM and lnCannex to confirm service expectations
and timelines.



 


		77)	A Randomisation Plan and Specifications Document (RPSD) will be prepared and held
by the Biostatistician. This RPSD will be approved by the PM and lnCannex before finalisation. Based on the approved Randomisation plan,
Randomisation Listswill be prepared for each cohort and issued as appropriate to facilitate randomised subject treatment per protocol,
with a copy issued to the TMF. Code break envelopes will be prepared and provided to the Investigator for use in case of emergency.



 


		78)	Following the start of study enrolment, the Biostatistician will develop a draft
Statistical Analysis Plan (SAP) to define the statistical analysis as required by the final protocol, which will be sent to lnCannex for
review and comment. lnCannex will provide consolidated comments to CNS for incorporation into the final draft.



 


		79)	A final draft version of the SAP will be issued to lnCannex for review to ensure
CNS have correctly incorporated lnCannex’s required changes. The SAP will then be finalised immediately prior to any statistical analysisfollowing
database lock.It isexpected that only minor changes related to the previous review will be required at this time. Any major changes or
amendments required to the final draft SAP, will be invoiced on a timesheet basis.



 


		80)	The SAP will contain appendiceslisting the planned TLFs. Shell/mock TLFs will be
created as an adjunct to the SAP and will be sent to lnCannex for separate review and approval.



 


		81)	Any additional changes and subsequent reviews to the SAP and/or TLF shells, and/or
any changes to the study that therefore necessitate changes to the SAP and/or TFL shells (e.g. major changes to the protocol after SAP
drafting and/or approval) will be subject to timesheet cost invoicing to lnCannex by CNS.



 


		82)	CDISC Submission Package:



 


		a.	CDISC Conversion - SDTM: CNS will prepare a CDISC-compliant SDTM data package that
will include: Domain-level SAS® datasets and transport files and the define.mxl file including the supporting annotated case report
form {blankcrf.pdf) and the Study Data Reviewer’s Guide {SDRG), as well as the applicable Pinnacle21 validation reports. The final SDTM
data package will be sent together with the final TLFpackage.



 


		b.	The SDTM data package will be based on the SDTM Implementation Guide and Coded
Terminology versions decided at thestart of the study. If required, the SDTM specifications can be reviewed by the sponsor prior to the
start of programming.



 



    	InCannex & CNS MCA & App 1	25 June 2020	Page 21 of 29



     


    

 


		c.	CDISC
                                            Mapping
                                            -
                                            ADaM: CNS will prepare
                                            a
                                            CDISC-compliant
                                            ADaM
                                            data package
                                            that will
                                            include:
                                            Analysis-level
                                            SAS® datasets and transport
                                            files and
                                            the define.mxl file
                                            including the supporting
                                            Analysis Data Reviewer’s Guide {ADRG), as well as the
                                            applicable
                                            Pinnacle21 validation reports.
                                            The
                                            final
                                            ADaM
                                            data package
                                            will be
                                            sent together
                                            with
                                            the
                                            final
                                            TLF
                                            package.

                                                                                 

	 	 	The
                              ADaM data package
                              will be based on the ADaM Implementation Guide
                              and Coded Terminology versions decided at the start
                              of the study.
                              If required, the
                              ADaM specifications can be reviewed by the
                              sponsor prior to the start
                              of programming.



 


		83)	CNS
                                            will perform all
                                            non-compartmental PK
                                            analyses for
                                            this study.
                                            PK
                                            analysis
                                            will be performed
                                            for
                                            the
                                            primary compound
                                            only/ and
                                            two metabolites. All
                                            PK analysis
                                            will
                                            be performed using validated
                                            applicable
                                            software
                                            and provided for
                                            inclusion
                                            in
                                            the
                                            CSR.



 


		84)	CNS
                                            will perform four (4) PD review of the protocol defined parameters namely:



 


		a.	Polysomnography
                                            (PSG)



 


		b.	Epworth
                                            Sleepiness Scale.



 


		c.	POMS
                                            (Profile
                                            of
                                            Moods State),



 


		d.	Short-from
                                            36.



 


	 	85)	All
final tabulation and analysis will be conducted using an appropriate, current and validated statistical software package. Draft TLF’s
will be provided to CNS Medical Writer and lnCannex for review. Upon receipt of lnCannex comments, the final TLFs will be prepared, and
following necessary review by the CNS team, final TLFs will be issued to lnCannex for sign off and acceptance. Major changes to the format/layout
from the approved TLF shells will be subject to timesheet cost invoicing to lnCannex by CNS. Additional round of review and/or updates
to the TLFs (beyond the 2 provided) will be subject to timesheet cost invoicing to lnCannex by CNS.








		86)	The
                                            estimated
                                            number of derived
                                            datasets (CDISC SDTM
                                            and ADaM) and Tables,
                                            Listings
                                            and
                                            Figures, to
                                            be provided
                                            by CNS is
                                            as
                                            follows:



 


	 	# CDISC SDTM Datasets	22
	 	# CDISC ADaM Datasets	10
	 	# Unique Tables	20
	 	# Unique Figures	4
	 	# Unique Listings	26
	 	# Repeat  Tables	14
	 	# Repeat Listings	4
	 	# Cohorts	3
	 	# Analytes	3



 





		87)	At
                                            the
                                            time of
                                            SAP finalisation, the
                                            assumptions
                                            around number
                                            of
                                            TFLs will
                                            be
                                            reviewed
                                            and
                                            any changes will be re-costed
                                            accordingly.



 


		88)	A
                                            formal
                                            statistical
                                            report will not
                                            be
                                            produced. Limited, per protocol tabulations/figures
                                            and
                                            listings
                                            will
                                            be prepared per protocol requirements and provided
                                            to
                                            the
                                            CNS
                                            Medical
                                            Writer for preparation of the
                                            Clinical
                                            Study Report (CSR).



 


Clinical
Study Report
(CSR)


 


		89)	CNS
                                            will be responsible
                                            for
                                            development of the
                                            CSR.
                                            CNS Medical Writer
                                            will
                                            join
                                            the initial team kick-off
                                            meeting with the
                                            PM
                                            and InCannex
                                            team to confirm
                                            service expectations
                                            and
                                            timelines.
	 	 	 



		90)	CNS
                                            will produce the CSR
                                            using
                                            standardized content templates that
                                            comply
                                            with
                                            all ICH
                                            and
                                            regional
                                            structure
                                            and formatting
                                            requirements.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 22 of 29



     


    

 


		91)	CNS
will develop a shell clinical study report in accordance with protocol requirements and ICH E3 standards for review by lnCannex.



 


		92)	Following finalisation of the TFLs, CNS will prepare a first draft CSR which will
be sent to lnCannex for review, comment and/or approval. lnCannex will provide consolidated comments to CNS for incorporation into the
final draft.



 


		93)	A second draft version of the CSR will then be issued to lnCannex for review to
ensure CNS have correctly incorporated lnCannex’s required changes. It is expected that only minor changes related to the previous review
will be required at this time. Any major changes or amendments required to the final draft CSR, may be invoiced on a timesheet basis.



 


		94)	CNS will finalise the CSR and following internal QC, the final CSR will be issued
for lnvestigational Site’s Pl and lnCannex approval and final sign off. Following sign off of the CSR, CNS will format the CSR.



 


		95)	Any
                                            additional changes and subsequent reviews
                                            to
                                            the
                                            CSR
                                            and/or any changes that
                                            require changes
                                            to the
                                            statistical
                                            analysis output and by definition changes to
                                            the
                                            SAP will be subject to timesheet cost invoicing
                                            to InCannex by
                                            CNS.



 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 23 of 29



     


    







	 	 	Clinical
Network Services (CNS) pty Ltd

Level 2. 381 MacArthur Ave

Hamilton. Brisbone. QLD 4007Australia

Tel: +61 (0)7 3719 6000

Email: ens ii clinical.net.au

Web: www.clinicol.net.au


ABN: 45 082 063 492

                                                                    

                                                                    


	Intelligent Development	 	 



 


		3	ESTIMATED PROJECT TIMELINES



 


The following
timeline projection isoffered as an educated yet realistic estimate of the study timeline from signing of the contract, through to the
return of Trial Master File. This estimation is highly dependent upon date of sign-off of contract, site availability / clinic dates,
EC approval and Subject recruitment. These timelines do not considerany holiday periodsand a final timeline will be provided by the CNS
PM upon contract award which will reflect any holiday periods and relevant input from lnvestigational Site.

 


[***] 


 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 24 of 29



     


    

 


[***] 


 


	[***]	[***]
	[***]	[***]
	[***]	[***]
	[***]	[***]


 



    	InCannex & CNS MCA & App 1	25 June 2020	Page 25 of 29



     


    

 


		4	SCOPE OF WORK & BUDGET



 


Thissection
details the activities and tasks that will be carried out by CNS as based upon Section
2 Assumptions. Any desired amendments to the
following section may necessitate CNS resubmitting an amended financial, and possibly timeline, Appendix. A budget has been carefully
prepared to ensure that CNS provides contract services at a cost that is deemed competitive and appropriate. CNS developsits budgets
on a unitcost basis with certain activities being timesheet cost due to the variability of such tasks. CNS proposed budgets are current
for up to 60 days from the date of this Appendix. All budgets are quoted in Australian Dollars (A$)


 


Reference: 


As Inc: As Incurred, PT: Pass Through, X: Responsible,
R: Review


 


		4.1	DETAILED MEDICAL
                                            WRITING BUDGET









 


[***]


  






    	InCannex & CNS MCA & App 1	25 June 2020	Page 26 of 29



     


    

 


		4.2	DETAILED
                                            CLINICAL BUDGET



 


[***]


 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 27 of 29



     


    







	 	 	Clinical Network Services (CNS) Pty
Ltd


Level 2, 381MacArthur Ave

Hamilton, Brisbane, OLD 4007, Australia

Tel: +61 (0)7 3719 6000

Email: cnsra•clinical.net.au

Web: www.clinical.net.au 

ABN: 45 082 063 492


                                                                    

                                                                    


	 	 	 
	Intelligent Development	 	 


 


		5	JRD
                                            PARTY COSTS






 


lnCannex
will co-ordinate and manage the 3rd party agreements for Site(s)/Laboratories,


 


		6	ESTIMATION
                                            OF ANTICIPATED PASS-THROUGH COSTS



 


All
costs incurred by CNS whilst delivering our services will be passed-through as a unit cost. Where costs have been incurred that have
not been unitised, they will be passed through as incurred to lnCannex on a monthly basis. CNS does not add any service
fee or margins to such costs.


 


		7	TIMESHEET
                                            COST BUDGETS



 





The agreed
budget isa fixed unit cost budget. However, given the nature of certain tasks that may or may not be needed, several tasks are denoted
as “Timesheet”, meaning CNS will invoice lnCannex per hour according to the type/level of person involved in performing the
task. Examples of such tasks that will be invoiced at timesheet cost are:


 


		●	Additional changes to any document prepared by CNS following incorporation of
amendmentsto final drafts of such documents






		●	Any face to face meetingswith lnCannex as requested by lnCannex






		●	Involvement of the Local Medical Monitor for hours above the monthly retainer of 5
hoursper month.






		●	SAEReporting/Follow Up by the Clinical team






		●	EDC/UAT/SOP/Therapeutic/Testing/Training



 


	 	8	OUT
                                            OF SCOPE



 





CNSmakesevery
effort to anticipate all service costs. However, it ispossible that services/tasks in excess of those agreed at the outset of the project
may be required or requested. CNS reserves the right to seek fair and appropriate compensation from lnCannex where services are to be
performed outside of this scope of work. CNS will obtain written agreement from lnCannex in such situations before delivery of those out
of scope services. Furthermore, CNS commits to rectifying any errors, etc., that are of its own making at no additional cost to lnCannex.


 


Examples
of Out of Scope tasks that will be invoiced at timesheet costs are:


 


		●	Development
                                            of additional versions of any document originally prepared by CNS or CNS review of additional
                                            version provided by 1nCannex or their Vendor.



		●	HREC
                                            Submission of Protocol Amendments



		●	Additional
                                            Project Specific CNS Team Training as requested by 1nCannex



		●	Site
                                            Audit attendance and response at 1nCannex ’s request.



		●	Additional
                                            site monitoring visitsrequired due to increased patient numbers.



 


The
following additional service ratesapply where timesheet cost rates apply:


 


	 	●	PA	=	[***]
	 	●	CRA	=	[***]
	 	●	Project  Manager	=	[***]





	 	●	Medical Writer	=	[***]
	 	●	Regulatory Consultant	=	
	 	●	Biostatistician	=	
	 	●	QA Manager	=	[***]
	 	●	Local Medical Monitor	=	[***]



 


	 	9	INVOICING
                                            AND PAYMENTS



 






	 	●	lnCannex
will pay CNS 15% of the agreed total fixed costs upon signature of this contract, serving as a security deposit.
		●	All invoices will be prepared in Australian dollars with fees increased by Goods and Services Tax (as
applicable) and line itemswill be expressed on a per unit basis per task performed and billed accordingly. The invoice will be provided
in the same level of detail as the agreed upon project budget and will include in such invoices all pass through costsincurred in the
previous month.






		●	All invoices will be prepared in Australian dollars and lnCannex agrees to pay all invoices by electronic
funds transfer (EFT) in Australian dollars. Payment terms are as described in the MCA.



 


[SIGNATURE
PAGE TO FOLLOW]


 






    	InCannex & CNS MCA & App 1	25 June 2020	Page 28 of 29



     


    

 


THIS
Appendix 1 to MCA (25 June 2020) dated 25 June 2020 is executed as of the effective date.


 


	
	EXECUTED by an authorised
    signatory of lnCannex Pty Ltd	 
	 	 
	/s/ Joel Latham	 
	Signature of Company Signatory	 
	 	 
	Joel Latham	 
	Name of Company Signatory	 
	 	 
	Managing Director	 
	Title of Company Signatory	 
	 	 
	29.6.20	 
	Date	 
	 	 
	EXECUTED by an authorised signatory of CLINICAL
    NETWORK SERVICES (CNS) PTY LTD	 
	 	 
	/s/ Russell
    Neal	 
		 
	Russell Neal	 
	Name of Company Signatory	 
	 	 
	Managing Director	 
	Title of Company Signatory	 
	 	 
		 
	Date	 


 


 


	InCannex &
    CNS MCA & App l	25
    June 2020	Page
29 of 29