Exhibit
10.6


 





 


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.


 


Clinical
Trial Research Agreement


Medicines
Australia – Standard Form


 


Details
of the parties


 





	Name
    of Institution:	University
    of Western Australia
	Address:	35
    Stirling Highway Crawley, WA 6009
	ABN:	37
    882 817 280
	Contact
    for Notices:	Dr
    Kathleen Maddison
	Fax
    for Notices:	[***]
	Phone
    Number:	[***]
	 
	Name
    of Sponsor:	Incannex
    Healthcare Ltd
	Address:	Unit
    207, 11 Solent Circuit
	Norwest
                                            2153

    New
    South Wales Australia

	ABN:	93
    096 635 246
	Contact
    for Notices:	Mr
    Joel Latham
	Fax
    for Notices:	N/A
	Phone
    Number:	[***]
	 
	Study
    Name:	Dose
    finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults
    with obstructive sleep apnoea (OSA)
	Protocol
    Number:	IHLOSAPOC1
	Date
    of Agreement:	As
    per date of full execution


 






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This
agreement is made between the Sponsor and Institution


 


Purpose
of the Agreement


 


According
to this Agreement:


 


	A.	The
                                            Sponsor is responsible for the initiation, management, and financing of the Study.



 


	B.	The
                                            Institution, through the Principal Investigator, is responsible for the conduct of the Study
                                            at the Study Site(s) which is/are under the control of the Institution.



 


	C.	The
                                            Study will be conducted on the terms and conditions set out below.



 


Operative
Provisions


 


	1.	INTERPRETATION



 


	1.1	In
                                            this Agreement:



 


Adverse
Event has the meaning given in the TGA document “Access to Unapproved Therapeutic Goods – Clinical Trials in Australia”
(October 2004) or its replacement.


 


Affiliate
means any company which (directly or indirectly) controls, is controlled by or is under common control with the Sponsor.


 


Agreement
means this Agreement, including all the Schedules.


 


Background
Intellectual Property (Background IP) of a party means information, techniques, know-how, software and materials (regardless
of the form or medium in which they are disclosed or stored) that are provided by or on behalf of that party to the other for use in
the Study (whether before or after the date of this Agreement) or used by that other party in conducting the Study, and all Intellectual
Property in them, but excludes the Study Materials.


 


Biological
Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.


 


Case
Report Form means a printed, optical or electronic document or database designed to record all of the information, which is required
by the Protocol to be reported to the Sponsor on each Study Participant.


 


Confidential
Information means:


 


		(1)	in
                                            respect of the Sponsor:



 


		(a)	all
                                            information collected in the course of, resulting from, or arising directly out of the conduct
                                            of the Study, whether at the Study Site or elsewhere;



 


		(b)	the
                                            Protocol, the Investigator’s Brochure, information related to the Protocol, Study Materials
                                            and Investigational Product;



 


		(c)	know-how,
                                            trade secrets, ideas, concepts, technical and operational information, scientific or technical
                                            processes or techniques, product composition or details owned by the Sponsor or its Affiliates;



 


		(d)	know-how,
                                            methodology, trade secrets, processes, sequences, structure and organisation of the Study;
                                            and



 


		(e)	information
                                            concerning the business affairs or clients of the Sponsor or its Affiliates;



 


		(2)	in
                                            respect of the Institution, information in relation to the Institution’s business,
                                            operations or strategies, intellectual or other property or actual or prospective suppliers
                                            or competitors, but
Confidential Information does not include Personal Information.



 




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Equipment
means the equipment supplied to the Institution by or on behalf of the Sponsor for the purposes of the Study, including that specified
in Schedule 1.


 


Essential
Documents means documents which individually and collectively permit evaluation of the conduct of the Study and the quality of the
data produced.


 


GCP
Guideline means the Committee for Proprietary Medicinal Products (CPMP)/International Conference on Harmonisation (ICH) Note for
Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted with annotation by the TGA, or its replacement.


 


GST
means the Goods and Services Tax payable under a GST Law.


 


GST
Law means the same as in A New Tax System (Goods and Services Tax) Act 1999 (Cth) as amended from time to time, and any regulations
made pursuant to that Act.


 


Institution
means the body so described on the first page of this Agreement.


 


Intellectual
Property means all present and future industrial and intellectual property rights, including without limitation:


 


		(1)	inventions,
                                            patents, copyright, trade business, company or domain names, rights in relation to circuit
                                            layouts, plant breeder’s rights, registered designs, registered and unregistered trademarks,
                                            know how, trade secrets and the right to have confidential information kept confidential,
                                            and any and all other rights to intellectual property which may subsist anywhere in the world;
                                            and
	 	 	 
		(2)	any
                                            application for or right to apply for registration of any of those rights.



 


Investigational
Product is the medicine or device being trialled or tested in the Study, as set out in Schedule 1, and includes where relevant
any placebo.


 


Investigator’s
Brochure is a compilation of the clinical and non-clinical data on the Investigational Product(s) which are relevant to the study
of the Investigational Product in humans.


 


Multi-centre
Study is a Study conducted by several investigators according to a single protocol at more than one study site.


 


NHMRC
means the National Health and Medical Research Council of the Commonwealth of Australia.


 


Personal
Information has the same meaning as in the Privacy Act 1988 (Cth).


 


Personnel
means employees, agents and/or authorized representatives, and includes, in the case of the Institution, the Principal Investigator.


 


Principal
Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.


 


Protocol
means the document identified in Schedule 6 which describes the objective(s), design, methodology, statistical considerations
and organisation of the Study, and subject to clause 2.3, as amended from time to time, as agreed by the parties, and most recently
approved by the Reviewing HREC.


 


Publish
means to publish, by way of a paper, article, manuscript, report, poster, internet posting, presentation slides, abstract, outline,
video, instruction material or other disclosure, the Study Materials, in printed, electronic, oral or other form.


 


Publication
has a corresponding meaning.


 




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Regulatory
Authority means any body which has jurisdiction over the conduct of the Study at the Study Site and includes the TGA and any overseas
regulatory authorities who may audit, or require to be audited, any part of the Study or Study Materials.


 


Relevant
Privacy Laws means the Privacy Act 1988 (Cth) and any other legislation, code or guideline which applies in the jurisdiction
in which the Study Site is located, and which relates to the protection of Personal Information.


 


Reviewing
HREC means the Human Research Ethics Committee reviewing the Study on behalf of the Institution as described in Schedule 1.


 


Serious
Adverse Event has the meaning given in the TGA document “Access to Unapproved Therapeutic Goods – Clinical Trials in
Australia” (October 2004) or its replacement.


 


Software
means the software supplied to the Institution by or on behalf of the Sponsor for the purposes of the Study, including that specified
in Schedule 1.


 


Sponsor
means the corporate entity so described on the first page of this Agreement.


 


Study
means the investigation to be conducted in accordance with the Protocol.


 


Study
Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including
a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.


 


Study
Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all
data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions,
know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study,
but excluding the Institution’s ordinary patient records.


 


Study
Participant means a person recruited to participate in the Study.


 


Study
Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.


 


TGA
means the Therapeutic Goods Administration of the Commonwealth of Australia or any successor body.


 


	1.2	Except
                                            where the context otherwise requires:



 


		(1)	clause
                                            headings are for convenient reference only and are not intended to affect the interpretation
                                            of this Agreement;



 


		(2)	where
                                            any word or phrase has a defined meaning, any other form of that word or phrase has a corresponding
                                            meaning;



 


		(3)	any
                                            reference to a person or body includes a partnership and a body corporate or body politic;



 


		(4)	words
                                            in the singular include the plural and vice versa;



 


		(5)	all
                                            the provisions in any schedule to this Agreement are incorporated in, and form part of, this
                                            Agreement and bind the parties;



 


		(6)	a
                                            reference to a replacement of a document or standard, means any document or ruling which
                                            amends, updates, replaces or supersedes that document or standard;



 


		(7)	if
                                            a period of time is specified and dates from a given day or the day of an act or event, it
                                            is to be calculated inclusive of that day;



 





		(8)	a
                                            reference to a monetary amount means that amount in Australian currency; and



 


		(9)	references
                                            to a party include its Personnel.



 




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	2.	THE
                                            STUDY



 


	2.1	The
                                            parties must comply with, and conduct the Study in accordance with, the Protocol and any
                                            conditions of the Reviewing HREC. In addition the parties must comply with the following,
                                            as applicable:



 


		(1)	any
                                            requirements of relevant Commonwealth or State or Territory laws or of Regulatory Authorities;



 


		(2)	the
                                            requirements of the TGA in Access to Unapproved Therapeutic Goods – Clinical Trials
                                            in Australia (October 2004) or its replacement and any other TGA publication or guideline
                                            that relates to clinical trials, or other such regulations or guidance governing the conduct
                                            of clinical research in the jurisdiction of the Study;



 


		(3)	the
                                            GCP Guideline;



 


		(4)	the
                                            principles that have their origins in the Declaration of Helsinki adopted by the World Medical
                                            Association in October 1996 (as accepted by the Australian Government); and
	 	 	 



		(5)	the
                                            NHMRC National Statement on Ethical Conduct in Human Research (2007) or its replacement,
                                            and any other relevant NHMRC publication or guideline that relates to clinical trials.



 


	2.2	If
                                            any issue relating to the safety of Study Participants arises which requires a deviation
                                            from the Protocol, the Institution through the Principal Investigator may immediately make
                                            such a deviation without breaching any obligations under this Agreement. If there is a need
                                            for such a deviation the Institution must notify the Sponsor and the Reviewing HREC of the
                                            facts and circumstance causing the deviation as soon as is reasonably practical, but in any
                                            event no later than 5 working days after the change is implemented.



 


	2.3	From
                                            time to time, the Sponsor may modify the Protocol by written notice to the Institution and
                                            Principal Investigator. Except where the modification is necessary to eliminate an immediate
                                            hazard to Study Participants or involves only logistical or administrative aspects of the
                                            trial, any modification may not be implemented before approval by the Reviewing HREC. If
                                            the parties determine that a modification will affect the cost of the Study, the parties
                                            shall amend Schedule 2 as agreed between them.



 


	3.	PRINCIPAL
                                            INVESTIGATOR



 


	3.1	Role
                                            of Principal Investigator



 


The
Institution has authorised the Principal Investigator as the person responsible on a day-to-day basis for the conduct of the Study. The
Principal Investigator does not have authority on behalf of the Institution to amend this Agreement or the Protocol.


 


	3.2	Liability
                                            for Principal Investigator



 


For
the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for
the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility
would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the
Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual
or other arrangement which may be in place between the Institution and the Principal Investigator.


 




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	3.3	Obligations
                                            and responsibilities



 


The
Institution is responsible for ensuring that the Principal Investigator:


 


		(1)	thoroughly
                                            familiarises themselves with the appropriate use of the Investigational Product(s), as described
                                            in the Protocol, Investigator’s Brochure, information relating to the Investigational
                                            Product and any other information sources provided by the Sponsor;



 


		(2)	ensures
                                            written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution
                                            prior to Study initiation. Written documentation of approval by the Reviewing HREC and the
                                            Institution must be provided to the Sponsor;



 


		(3)	conducts
                                            the Study according to the Protocol without changes, except as provided in clause 2.2
                                            or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved
                                            in accordance with clause 3.3(5);



 


		(4)	completes
                                            (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of
                                            financial disclosure (an example that meets this requirement is Food and Drug Administration
                                            Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators)
                                            before the commencement of the Study and as otherwise required, and consents to the disclosure
                                            of the completed form to overseas regulatory agencies, if required;



 


		(5)	ensures
                                            that any amendments to the Protocol are approved by the Reviewing HREC and Sponsor prior
                                            to implementation of the amendment;



 


		(6)	ensures
                                            that the Sponsor’s prior written consent is obtained to any advertisement in respect
                                            of the Study;
	 	 	 



		(7)	provides
                                            the Sponsor with evidence of the Principal Investigator’s qualifications through a
                                            current curriculum vitae and/or other relevant documentation and a list of appropriately
                                            qualified persons to whom they have delegated significant Study-related duties, if required;



 


		(8)	uses
                                            their best endeavours to recruit the target number of Study Participants, within the recruitment
                                            period, specified in Schedule 1, provided that if the overall target number of Study
                                            Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment;



 


		(9)	is
                                            available when a clinical research representative of the Sponsor visits the Study Site, as
                                            mutually agreed prior to the visit, and is contactable by telephone or electronic mail as
                                            frequently as is reasonably required;



 


		(10)	notifies
                                            the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious
                                            Adverse Events) that occur during the course of the Study in accordance with the Protocol
                                            and relevant ethical and regulatory guidelines, and, in the case of the Institution and the
                                            Reviewing HREC, with their policies and procedures;
	 	 	 



		(11)	completes
                                            Case Report Forms within the agreed time period. The Principal Investigator will ensure that
                                            Study Participants’ identifying information are removed from all records being transferred
                                            to the Sponsor;



 


		(12)	provides
                                            regular written progress reports to the Sponsor in relation to the Study as required by the
                                            Protocol;



 


		(13)	completes
                                            and returns to the Sponsor as required any Study related materials within a reasonable time
                                            period;



 


		(14)	is
                                            not subject to any obligations, either contractually or in any other way, which would unreasonably
                                            interfere with or prohibit the performance of work related to this Study; and



 


		(15)	ensures
                                            that informed consent to participate in the Study is obtained from each Study Participant
                                            prior to their enrolment in the Study and documented using an information and consent document
                                            which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC.



 




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	4.	INSTITUTION
                                            OBLIGATIONS AND RESPONSIBILITIES



 


	4.1	If
                                            the Principal Investigator leaves the Institution or otherwise ceases to be available, then:



 


		(1)	the
                                            Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon
                                            as practicable a replacement reasonably acceptable to both parties; and



 


		(2)	the
                                            Sponsor may require recruitment into the Study by the Institution to cease or move the Study
                                            to a different Study Site.



 


	4.2	If
                                            the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2),
                                            (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform
                                            those obligations and rectify and make good any breach. The Institution will ensure that
                                            any Personnel who assist in the conduct of the Study are informed of and agree to abide by
                                            all terms of this Agreement relevant to the activities they perform.



 


	4.3	The
                                            Institution warrants that, to the best of its knowledge, it and its affiliates and any other
                                            person involved in the conduct of the Study, including the Principal Investigator, are properly
                                            registered with appropriate professional registration bodies, have not been disqualified
                                            from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority.
                                            Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes
                                            aware of any such disqualification, disbarment or ban.



 


	4.4	The
                                            Institution will not engage in any conduct on the Sponsor’s behalf which is in violation
                                            of, or potentially in violation of, any applicable local or foreign laws or regulations.



 


	4.5	The
                                            Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised
                                            or paid, either directly or indirectly, any Benefit to a government official (including,
                                            but not limited to, a healthcare professional employed by a government-owned healthcare facility)
                                            to induce such government official to act in any way in connection with his or her official
                                            duties with respect to services performed under this Agreement or to otherwise obtain an
                                            improper advantage for the Institution or the Sponsor (Improper Payment), and has
                                            not received an Improper Payment, and will not offer, promise, pay, authorise or receive
                                            any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but
                                            is not limited to money, financial or other advantage, travel expenses, entertainment, business
                                            or investment opportunities, charitable donations or any other thing of value.



 


	4.6	The
                                            Institution must have adequate security measures to ensure the safety and integrity of the
                                            Investigational Product, Essential Documents and Study records and reports, Equipment and
                                            any Study related materials held or located at the Study Site.



 


	4.7	Subject
                                            to clause 9, the Institution will allow regular monitoring visits in accordance with
                                            the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities
                                            or as specified in the Protocol and permit access to the Essential Documents (including original
                                            records), Study records, reports, other Study related materials and its Personnel as soon
                                            as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC
                                            or any third party designated by the Sponsor. Any such access is to take place at times mutually
                                            agreed, during business hours and subject to such reasonable conditions relating to occupational
                                            health and safety, security, and confidentiality as the Institution may require.



 




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	4.8	The
                                            Institution will make available adequate facilities, equipment and any other resource of
                                            the Institution reasonably required to safely follow the Protocol, provided that any amendments
                                            to the Protocol which take place after the execution of this Agreement and requiring any
                                            additional use of facilities, equipment, staff or resources, have been approved in writing
                                            by the Institution and the Reviewing HREC.



 


	4.9	The
                                            Institution will have an adequate number of appropriately qualified Personnel for the foreseen
                                            duration of the Study and ensure that such Personnel are adequately informed about the Protocol,
                                            Investigational Product(s), and their Study-related duties and functions. The Personnel
                                            appointed by the Institution to assess Study Participants will attend an investigator meeting
                                            or a pre-study/initiation meeting, where appropriate.



 


	4.10	The
                                            Institution must retain and preserve a copy of all Study Materials, including copies of signed
                                            consent forms, Case Report Forms, Protocol, information relating to the Investigational Product,
                                            correspondence and investigator files for at least 15 years from Study Completion and must
                                            ensure that no Study related materials are destroyed before the expiration of this time period
                                            without the written approval of the Sponsor. The Institution agrees to notify the Sponsor
                                            before destroying any Study Materials and agrees to retain the Study Materials for such longer
                                            period as reasonably required by the Sponsor at the Sponsor’s expense.



 


	4.11	The
                                            Institution will ensure that the Study is subject to the continuing oversight of the Reviewing
                                            HREC throughout its conduct.
	 	 



	4.12	If
                                            the Institution is contacted by any Regulatory Authority in connection with the conduct of
                                            the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing
                                            so by law.
	 	 



	4.13	The
                                            Institution will provide the Sponsor with all reasonable assistance and cooperation to rectify
                                            any matter raised by a Regulatory Authority or as the result of an audit of the Institution
                                            or Study Site. This includes execution of any documents reasonably requested by the Sponsor
                                            in connection with the requirements of a Regulatory Authority or the Sponsor as a result
                                            of such an audit. The cost will be borne by the Sponsor unless such rectification is due
                                            to the default of the Institution or the Principal Investigator.
	 	 



	4.14	The
                                            Institution shall obtain approval, in writing, from the Sponsor for any press statements
                                            or promotional statements regarding the Study or the Investigational Product(s) before the
                                            statements are released, unless the statement or disclosure is required by:



 


		(1)	law;



 


		(2)	any
                                            policy, guideline or direction of government or any government department or agency;
	 	 	 



		(3)	any
                                            Regulatory Authority; or
	 	 	 



		(4)	is,
                                            in the absolute discretion of the Institution, Minister for Health, Department of Health
                                            or any government official, reasonably necessary in the public interest or to protect the
                                            health and safety of any individual.






 






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	5.	SPONSOR
                                            OBLIGATIONS AND RESPONSIBILITIES



 


	5.1	Prior
                                            to the Agreement being executed, the Sponsor must provide the Principal Investigator, and,
                                            through the Principal Investigator, the Institution and the Reviewing HREC, with all current
                                            and relevant information regarding the Investigational Product as reasonably required to
                                            justify the nature, scope and duration of the Study.
	 	 



	5.2	The
                                            Sponsor will implement and maintain quality assurance and quality control systems with written
                                            standard operating procedures to ensure that the Study can be conducted and data generated,
                                            documented, recorded and reported in compliance with all of the documents referred to in
                                            clause 2.1.



 


	5.3	The
                                            Sponsor will designate appropriately qualified personnel to advise on Study-related medical
                                            questions or problems.



 


	5.4	The
                                            Sponsor will monitor the application of the Investigational Product in other places (both
                                            within and outside Australia) and advise the Institution, through the Principal Investigator,
                                            and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational
                                            Product from any other market for safety reasons.
	 	 



	5.5	The
                                            Sponsor will notify the Institution of any Adverse Events (including Serious Adverse Events)
                                            that occur during the course of the Study (either at the Study Site or other study sites,
                                            including overseas sites) which may require alteration of the conduct of the Study, or which
                                            may affect the rights, interests, safety or well-being of Study Participants.



 


	5.6	The
                                            Sponsor will cooperate with the Institution and/or the Reviewing HREC in investigating any
                                            Adverse Event (including Serious Adverse Event) arising out of or in connection with the
                                            Study.
	 	 



	5.7	To
                                            assist the Institution to comply with clause 8, the Sponsor will provide the Institution
                                            with adequate information and all necessary Investigational Product accountability forms.



 


	5.8	The
                                            Sponsor will provide indemnity to the Institution and members of the Reviewing HREC against
                                            claims arising from the Study on the terms and conditions set out in the relevant Medicines
                                            Australia Form of Indemnity for Clinical Trials as set out in Schedule 3.



 


	5.9	The
                                            Sponsor will comply with the Medicines Australia Guidelines for Compensation for Injury Resulting
                                            from Participation in a Company-sponsored Trial as specified in Schedule 5.
	 	 
	5.10	The
                                            Sponsor will maintain insurance with respect to its activities and indemnity obligations
                                            under this Agreement in accordance with Schedule 4. This insurance is to be evidenced
                                            by a certificate of insurance, as requested by the Institution from time to time.



 


	6.	PAYMENTS



 


	6.1	In
                                            consideration of the Institution conducting the Study, the Sponsor will pay to the Institution
                                            as nominated in Schedule 2 in the manner and on the basis of the amounts and at the
                                            times set out in Schedule 2. The amounts set out in Schedule 2 do not include
                                            GST. At the time of payment, the Sponsor must pay to the Institution any amount of GST that
                                            the Institution is required to pay in addition to the amounts set out in Schedule 2,
                                            and in accordance with GST Law.



 


	6.2	The
                                            Sponsor reserves the right to refuse to pay to the Institution payments specific to Study
                                            Participants entered into the Study who do not meet the entry criteria specified in the Protocol.



 




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	6.3	If
                                            a Study Participant discontinues their participation in the Study or if the Study is terminated
                                            as a whole, only those costs incurred up until the date of discontinuation or termination,
                                            including costs of final visit and completion of all Case Report Forms, will be paid.



 


	6.4	Payments
                                            will be made by the Sponsor upon either receipt of a valid tax invoice or a “Recipient
                                            Created Tax Invoice” issued by the Sponsor.



 


	6.5	The
                                            Sponsor and the Institution each warrant that they are registered under GST Law. Tax invoices
                                            must identify supplies for which GST is payable.



 


	6.6	The
                                            final payment will be made following Study Completion.



 


	6.7	No
                                            part of any consideration paid hereunder is for the recommending or arranging for the referral
                                            of business or the ordering of items or services.



 


	6.8	Neither
                                            this Agreement nor any consideration paid hereunder is contingent upon the Institution’s
                                            use or purchase of any of the Sponsor’s products.



 


	7.	PROVISION
                                            OF EQUIPMENT & SOFTWARE



 


	7.1	The
                                            Sponsor will provide the Institution and Principal Investigator with the Equipment and Software
                                            at the Sponsor’s expense. Unless otherwise agreed by the parties in writing,
                                            the Equipment and Software will be used only by the Principal Investigator and Personnel
                                            involved in the conduct of the Study and only for the purposes of the Study.



 


	7.2	If
                                            proper usage of the Equipment or Software requires training, the Institution agrees that:



 


		(1)	the
                                            Principal Investigator and Institution’s Personnel will make themselves available for
                                            training in using the Equipment and Software, at the Sponsor’s expense; and



 


		(2)	the
                                            Equipment and Software will only be used as described in written directions provided by the
                                            Sponsor.



 


	7.3	The
                                            Equipment will be at the risk of the Sponsor, but the Institution will take reasonable care
                                            in the use and secure storage of the same and the Institution is responsible for damage caused
                                            to or by the Equipment by the negligence of its Personnel.



 


	7.4	At
                                            the completion of the Study or at the Sponsor’s request, the Institution will, unless
                                            otherwise specified, return to Sponsor, at the Sponsor’s expense, the Equipment and
                                            Software and all related training materials and documentation.



 


	7.5	The
                                            Sponsor will cooperate with the Institution in maintaining, at the Sponsor’s expense,
                                            the Equipment in good working order, and ensuring that it is in a safe condition and compliant
                                            with the requirements of the relevant licensing and safety authorities at all times.



 


	7.6	The
                                            Institution will not copy the Software unless specifically authorised by the Sponsor.



 


	8.	INVESTIGATIONAL
                                            PRODUCT



 


	8.1	The
                                            Institution must:



 


	 	(1)	ensure
                                            that all Investigational Product made available by the Sponsor is used strictly according
                                            to the Protocol and are not used for any other purposes, unless agreed in writing by the
                                            Sponsor;
	 	 	 



	 	(2)	provide
                                            a written explanation accounting for any missing Investigational Product;






 






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		(3)	not
                                            charge a Study Participant or third-party payer for Investigational Product or for any services
                                            reimbursed by the Sponsor under this Agreement;
	 	 	 



		(4)	keep
                                            all Investigational Product under appropriate storage conditions (including any conditions
                                            specified in the Protocol) and in a secured area accessible only to authorised Personnel;
                                            and



 


		(5)	ensure
                                            that complete and current records are maintained for all received, dispensed and returned
                                            Investigational Product.



 


	8.2	The
                                            Sponsor will supply the Principal Investigator with such quantities of the Investigational
                                            Product as will be required for the purpose of the Study. All supplied Investigational Product
                                            will be packaged in safe and appropriately labelled containers. The Sponsor will at all times
                                            remain the sole owner of the Investigational Product.
	 	 



	8.3	On
                                            termination of this Agreement, the Institution must promptly return any unused Investigational
                                            Product to the Sponsor, or, if requested by the Sponsor, destroy it and provide evidence
                                            of such destruction.



 


	9.	CONFIDENTIALITY



 


	9.1	Subject
                                            to clause 9.2, each party must not, and must ensure their Personnel do not, use or
                                            disclose any Confidential Information of the other party, other than where and only to the
                                            extent that such use or disclosure is necessary for the performance of the Study, the exercise
                                            of its rights or the performance of its obligations under this Agreement.



 


	9.2	The
                                            Institution may use or disclose Sponsor Confidential Information in any of the following
                                            circumstances:



 


		(1)	for
                                            the purposes of complying with the Institution’s internal complaint procedures, accident
                                            reporting procedures, quality assurance activities, disciplinary procedures or any applicable
                                            policy in relation to patient safety, Adverse Events and/or reportable incidents;



 


		(2)	for
                                            the purposes of disclosing any material risks, identified during the Study or subsequent
                                            to it, to Study Participants, Principal Investigators, medical practitioners administering
                                            treatment to Study Participants, Reviewing HRECs and Regulatory Authorities;



 


		(3)	for
                                            the purposes of complying with the requirements of any Regulatory Authority;



 


		(4)	to
                                            enable the Reviewing HREC to monitor the Study;



 


		(5)	where
                                            the Sponsor consents in writing to the disclosure;



 


		(6)	as
                                            part of a publication issued under the provisions of clause 11;



 


		(7)	where
                                            release of the Confidential Information is required by law, with notice as soon as reasonably
                                            practical to the Sponsor, and subject to the Institution upon request providing reasonable
                                            assistance to enable the Sponsor to obtain a protective order or other remedy to resist disclosure
                                            or ensure confidential treatment for any required disclosure;
	 	 	 



		(8)	for
                                            the purposes of the Institution seeking legal advice; or



 


		(9)	disclosure
                                            to the Institution’s insurer.



 




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	9.3	Where
                                            Confidential Information is disclosed in accordance with clause 9.2 (1), (4),
                                            (8) or (9) the Confidential Information must only be used in connection with
                                            the legitimate purposes of the Institution, and only disclosed to those who have a need to
                                            know it for such purposes and are obligated to keep the information confidential.






 


	9.4	The
                                            Sponsor may disclose Institution Confidential Information to its lawyers for the purposes
                                            of obtaining legal advice or to its Affiliates but only on a needs to know and confidential
                                            basis. The Sponsor may disclose Institution Confidential Information if required by law,
                                            with notice as soon as reasonably practical to the Institution, and subject to the Sponsor
                                            upon request providing reasonable assistance to enable the Institution to obtain a protective
                                            order or other remedy to resist disclosure or ensure confidential treatment for any required
                                            disclosure.



 


	9.5	The
                                            parties are responsible for ensuring that their Personnel are aware of the obligations in
                                            respect of Confidential Information in this clause 9 and are bound in similar terms
                                            to keep such information confidential.



 


	9.6	Information
                                            will not be Confidential Information and subject to the provisions of this clause 9
                                            where:






 


		(1)	the
                                            information has been independently received from a third party who is free to disclose it;
	 	 	 



		(2)	the
                                            information is in or has entered the public domain other than as a result of a breach of
                                            this Agreement;



 


		(3)	the
                                            party already knew the information, the prior knowledge of which it can document by prior
                                            written records; or



 


		(4)	the
                                            party independently develops, discovers or arrives at the information without use, reference
                                            to, or reliance upon, the Confidential Information.



 


	10.	PRIVACY



 


	10.1	Each
                                            party must ensure that any Personal Information of Study Participants or Personnel it obtains
                                            or holds as a result of the conduct of the Study is collected, stored, used and disclosed
                                            by it in accordance with the Relevant Privacy Laws.
	 	 



	10.2	Each
                                            party will promptly report to the other party any unauthorised access to, use or disclosure
                                            of Personal Information of Study Participants (“Incident”) of which it becomes
                                            aware, and will work with the other party to take reasonable steps to remedy the Incident.



 


	11.	PUBLICATIONS



 


	11.1	The
                                            Institution, Principal Investigator and other investigators (each a Discloser) involved
                                            in the Study have the right to Publish the methods, results of, and conclusions from, the
                                            Study, subject to this clause and in accordance with copyright law.



 


	11.2	If
                                            the Study is a Multi-centre Study, then the Institution agrees that no Publication of the
                                            Study results may be made until Publication of the results of the Multi-centre Study or 2
                                            years after Study Completion, whichever is the sooner. The further provisions of this clause
                                            still apply to any such Publication.



 


	11.3	The
                                            Institution must ensure that the Discloser gives a copy of any proposed Publication drafted
                                            by them and/or other Personnel involved in the conduct of the Study to the Sponsor at least
                                            40 days before forwarding it to any person that is not bound by the confidentiality obligations
                                            set out in clause 9.



 


	11.4	The
                                            Sponsor may, within that 40-day period do any one or more of the following:



 


		(1)	provide
                                            comments on the proposed Publication to the Institution, in which case the Institution must
                                            consider such comments but will not be bound to follow them;
	 	 	 



		(2)	request
                                            delay of Publication for no more than 120 days to allow the Sponsor to file patent applications
                                            or take other measures to preserve or secure its Intellectual Property, in which case the
                                            Institution must abide by that request; or
	 	 	 



		(3)	request
                                            that the Discloser remove specified Confidential Information (other than the results of the
                                            Study) from the Publication, in which case the Institution must remove such specified Confidential
                                            Information as is reasonably required to protect the Intellectual Property of the Sponsor.



 




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	11.5	If
                                            the Institution has not received any comments from the Sponsor on the proposed Publication
                                            within 40 days of giving a copy to the Sponsor under clause 11.3, the Discloser may
                                            proceed to make the Publication.
	 	 



	11.6	Where
                                            the Sponsor intends to Publish the method, results or conclusions from the Study, any person
                                            named as an author on that Publication will be given a reasonable opportunity to review the
                                            Publication. Any person acknowledged as an investigator of the Study in the Publication will
                                            be given a reasonable opportunity to request the removal of his or her name from the Publication
                                            and the Sponsor shall comply with any such request.



 


	11.7	In
                                            all Publications the Sponsor’s support of the Study shall be acknowledged.



 


	11.8	The
                                            Sponsor may Publish a summary of the Study Results and conclusions on the Sponsor’s
                                            on-line Clinical Trial Register before or after Publication by another method.
	 	 



	11.9	The
                                            Sponsor may freely use, copy and disseminate any manuscript following its Publication in
                                            a journal without further obligation to the Institution or Discloser.
	 	 



	11.10	The
                                            Sponsor may only use the Institution’s and Investigators’ names:



 


		(1)	in
                                            relation to the publication of the Study on reputable clinical trials registers and websites
                                            in accordance with the CONSORT 2010 Statement;
	 	 	 



		(2)	in
                                            Study publications and communications including Study newsletters made to the Institution
                                            and any other person which is subject to substantially the same confidentiality obligations
                                            as those set out in clause 9, in relation to performance of the Study; or



 


		(3)	in
                                            Study publications and communications made to any third party not subject to the confidentiality
                                            obligations set out in clause 9, with the Institution’s prior written consent.



 


	12.	STUDY
                                            MATERIALS AND INTELLECTUAL PROPERTY
	 	 



	12.1	The
                                            Sponsor grants to the Institution and its Personnel the right to use the Background IP of
                                            the Sponsor and the Study Materials as required to carry out the Study and perform this Agreement.
                                            Except for this right, neither the Institution nor any of its Personnel acquires any right
                                            or interest in any Intellectual Property provided by or on behalf of the Sponsor.
	 	 



	12.2	In
                                            order to carry out the Study, the Institution may use Intellectual Property which is part
                                            of the Institution’s Background IP. Any such Background IP remains the sole property
                                            of the Institution. The Institution grants to the Sponsor a non-exclusive, perpetual, royalty
                                            free licence to use (including the right to sub-licence) the Institution’s Background
                                            IP solely for the purpose of the commercialisation of the Study Materials.



 


	12.3	Subject
                                            to clause 12.2, all Intellectual Property in the Study Materials will vest automatically
                                            upon its creation in the Sponsor, and the Institution presently assigns to the Sponsor all
                                            Intellectual Property rights contained in the Study Materials. The Institution agrees to
                                            execute or procure the execution by its Personnel of any documents reasonably necessary to
                                            give effect to this assignment, at the Sponsor’s expense.



 


	12.4	The
                                            Institution must promptly disclose and communicate in writing to the Sponsor full particulars
                                            of any Intellectual Property that the Institution or Principal Investigator make, discover
                                            or conceive in the course of the Study that is directly related to the Study Materials.









 




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	13.	TERM
                                            AND TERMINATION



 


	13.1	This
                                            Agreement commences from the date specified on the first page of this Agreement, or if such
                                            date is not included on the date this Agreement is last signed by either the Sponsor or Institution.
                                            In the ordinary course of events this Agreement terminates when the Sponsor makes its final
                                            payment to the Institution.



 


	13.2	A
                                            party may terminate this Agreement with 30 days prior written notice or such shorter time
                                            period as is reasonably required in the circumstances if the other party:



 


		(1)	is
                                            in breach of any obligations under the Agreement or the Protocol (including without just
                                            cause to meet a timeframe) and fails to remedy such breach where it is capable of remedy
                                            within 30 days of a written notice from the terminating party specifying the breach and requiring
                                            its remedy;



 


		(2)	is
                                            declared insolvent or has an administrator or receiver appointed over all or any part of
                                            its assets or ceases or threatens to cease to carry on its business; or



 


		(3)	assigns
                                            this Agreement to a person considered unsuitable to perform the Agreement as set out in clause
                                            19.3.



 


	13.3	In
                                            addition to clause 13.2, a party may terminate this Agreement immediately by written
                                            notice to the other party if it believes on reasonable grounds that:



 


		(1)	continuing
                                            the Study poses an unacceptable risk to the rights, interests, safety or well-being of Study
                                            Participants; and



 


		(2)	terminating
                                            this Agreement is the most appropriate way to respond to that risk.



 


	13.4	The
                                            Sponsor may terminate this Agreement if the Institution breaches clause 4.5 or if
                                            the Sponsor learns that the Institution is making, or has made, Improper Payments (within
                                            the meaning of clause 4.5) to government officials with respect to services performed
                                            on behalf of the Sponsor or any other company. Further, in the event of such termination,
                                            the Institution will not be entitled to any further payment or compensation.



 


	13.5	The
                                            Sponsor may terminate this Agreement with 30 days prior written notice to the Institution.
                                            In the event of such early termination, the Sponsor will pay the reasonable costs of the
                                            Institution relating to the Study calculated in accordance with Schedule 2.



 


	13.6	In
                                            the event of termination, the Institution must promptly initiate all appropriate action to
                                            close the Study and, subject to any applicable retention requirements imposed by law, return
                                            to the Sponsor (or destroy if requested by the Sponsor, and provide evidence of such destruction)
                                            any completed Case Report Forms and other materials received from the Sponsor before Study
                                            Completion.
	 	 



	13.7	In
                                            the event of termination the Sponsor must take all appropriate action to close out the Study
                                            Site in a timely manner.
	 	 



	13.8	In
                                            the event of early termination, the Sponsor will cooperate with the Institution to ensure
                                            that Study Participants who may be affected by termination receive adequate medical care.
                                            This may include the provision of Investigational Product in certain circumstances at the
                                            Sponsor’s expense.



 


	13.9	The
                                            following provisions survive termination of this Agreement, clauses 1, 3.2, 3.3(11), 4.6,
                                            4.7, 4.10, 4.12, 4.13, 4.14, 5.8, 5.9, 5.10, 6.1, 8.3, 9, 10, 11, 12, 13.5, 13.6, 13.7, 13.8,
                                            13.9, 14, 15, 16, 18 and 20.






 






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	14.	DISPUTES



 


	14.1	No
                                            party may commence legal proceedings against another in respect of a dispute arising in relation
                                            to this Agreement (except for urgent interlocutory relief) unless the parties have complied
                                            with this clause and that party has first notified the other party in writing of the dispute
                                            and has used all reasonable endeavours to resolve the dispute with the other party within
                                            28 days of the giving of that notice (Initial Period).



 


	14.2	If
                                            the dispute is not resolved within the Initial Period, then the dispute shall be referred
                                            within a further 28 days to the Australian Disputes Centre for mediation or any other agreed
                                            venue which conducts mediation. The parties will by agreement appoint a mediator to mediate
                                            the dispute in this forum. If the parties cannot agree to a mediator within 14 days of the
                                            end of the Initial Period, then the mediator will be nominated by the then current President
                                            of the Law Society of the State or Territory in which the Institution is located. Any documents
                                            produced for the mediation are to be kept confidential and cannot be used except for the
                                            purpose of settling the dispute.
	 	 



	14.3	Each
                                            party must bear its own costs of resolving a dispute under this clause, and unless the parties
                                            otherwise agree, the parties to the dispute must bear equally the costs of the mediator.
	 	 



	14.4	In
                                            the event that the dispute is not settled at mediation within 28 days (or such other period
                                            as the parties agree in writing) after the appointment of the mediator, then the parties
                                            are free to pursue any other procedures available at law for the resolution of the dispute.



 


	15.	APPLICABLE
                                            LAW



 


This
Agreement will be governed by, and construed in accordance with, the law for the time being in force in the State or Territory in which
the Institution is located and the parties submit to the jurisdiction of that State or Territory and courts entitled to hear appeals
from those courts.


 


	16.	NOTICES



 


	16.1	A
                                            notice, consent, approval or other communication (each a notice) under this Agreement
                                            must be:



 


		(1)	delivered
                                            to the party’s address; or



 


		(2)	sent
                                            by pre-paid mail to the party’s address; or



 


		(3)	transmitted
                                            by facsimile to the party’s address.



 


	16.2	A
                                            notice given by a party in accordance with this clause is treated as having been given and
                                            received:



 


		(1)	if
                                            delivered to a person’s address, on the day of delivery if a business day, otherwise
                                            on the next business day; or



 


		(2)	if
                                            sent by pre-paid mail, on the third business day after posting; or



 


		(3)	if
                                            transmitted by facsimile to a person’s address and a correct and complete transmission
                                            report is received, on the day of transmission if a business day, otherwise on the next business
                                            day.



 


	16.3	The
                                            addresses of the parties for the purposes of giving any notice are set out on the front page
                                            of this Agreement.



 


	17.	WAIVER



 


	17.1	No
                                            right under this Agreement is waived or deemed to be waived except by notice in writing signed
                                            by the party waiving the right. A waiver by any party in respect of any breach of a condition
                                            or provision of this Agreement will not be deemed to be a waiver in respect of any other
                                            breach.









 


	17.2	Failure
                                            or delay by any party to enforce any provision of this Agreement will not be deemed to be
                                            a waiver by that party of any right in respect of any other such breach.



 




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	18.	VARIATIONS



 


No
variations of this Agreement are legally binding on any party unless evidenced in writing signed by all parties.


 


	19.	ASSIGNMENT



 


	19.1	Subject
                                            to clause 19.2, a party (the Assigning Party) may assign its rights or novate
                                            its rights and obligations under this Agreement after obtaining the prior written consent
                                            of the other party (the Other Party).



 


	19.2	The
                                            Assigning Party’s request for the Other Party’s consent to an assignment or novation of this
                                            Agreement must include:



 


		(1)	the
                                            name and the address of the proposed assignee or novatee;



 


		(2)	a
                                            copy of the proposed deed of assignment or novation; and



 


		(3)	such
                                            other information as the Other Party reasonably requires.



 


	19.3	Provided
                                            the proposed novatee is an Australian entity, the Other Party must give its consent promptly
                                            if:



 


		(1)	the
                                            Assigning Party provides evidence that ought reasonably satisfy the Other Party that the
                                            proposed novatee is financially secure and has the ability to carry out the Assigning Party’s
                                            obligations under this Agreement;



 


		(2)	the
                                            proposed novatee signs a deed or agreement in which it covenants with the Other Party and
                                            the Assigning Party to perform the obligations of the Assigning Party under this Agreement;
	 	 	 



		(3)	the
                                            Assigning Party is not in breach of this Agreement; and



 


		(4)	the
                                            Assigning Party pays the Other Party’s reasonable costs of giving its consent.



 


	19.4	The
                                            Assigning Party remains liable for its obligations under this Agreement even if it assigns
                                            its rights pursuant to clause 19.1.



 


	20.	SUBCONTRACTING



 


	20.1	The
                                            Sponsor may subcontract any of its obligations under this Agreement, save for the obligations
                                            set out in clauses 5.8, 5.9 and 5.10. The Sponsor remains responsible for all
                                            subcontracted obligations and is liable for all acts and omissions of any subcontractor as
                                            if they were the Sponsor’s acts and omissions. In the event that the Sponsor subcontracts
                                            with another party to perform any of the Sponsor’s obligations under this Agreement, the
                                            Sponsor is bound by and will observe its obligations under clause 9.1 in its dealings
                                            with the subcontractor.
	 	 



	20.2	No
                                            subcontractor will have any rights under this Agreement against the Institution or be entitled
                                            to receive any payment from the Institution.



 


	20.3	For
                                            the purpose of this Agreement only, and as between the Sponsor and the Institution only,
                                            where the Institution subcontracts any of its obligations under this Agreement, the Institution
                                            remains responsible for all subcontracted obligations and is liable for all acts and omissions
                                            of any subcontractor as if they were the Institution’s acts and omissions.



 




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	21.	ENTIRE
                                            AGREEMENT



 


This
Agreement constitutes the entire agreement between the parties in relation to the Study and supersedes all prior representations, agreements,
statements and understandings, whether verbal or in writing in relation to the Study.


 


	22.	FURTHER
                                            DOCUMENTS



 


Each
party will do anything (including executing any document) and will ensure that its Personnel do anything (including executing any document),
that the other party may reasonably require to give full effect to this Agreement.


 


	23.	SEVERANCE



 


If
any part of this Agreement is prohibited, void, voidable, illegal or unenforceable, then that part is severed from this Agreement but
without affecting the continued operation of this Agreement.


 


	24.	RELATIONSHIP
                                            OF THE PARTIES



 


Nothing
in this Agreement creates a relationship of employer and employee, principal and agent, joint venture or partnership between the parties
and no party will hold itself out as an agent for another.


 


	25.	FORCE
                                            MAJEURE



 


If
any party is delayed or prevented from the performance of any act required under this Agreement by reason of any act of God, act of nature,
including any epidemic or outbreak of pandemic disease, fire, act of government or state, war, civil commotion, insurrection, embargo,
prevention from or hindrance in obtaining raw material, energy or other supplies, labour disputes of whatever nature or whatever reason
beyond the control of the party (a Force Majeure Event), the affected party shall promptly notify the other party in writing,
giving details of the Force Majeure Event, the acts affected by the Force Majeure Event and the extent to which they are affected, and
performance of such acts shall be excused for the period of such event provided that if such interference lasts for any period in excess
of 30 days either party may, by written notice to the other, terminate this Agreement.


 


	26.	COUNTERPARTS



 


This
Agreement may be executed in any number of counterparts. All counterparts taken together are deemed to constitute one and the same Agreement.


 


	27.	CONFLICT



 


In
the event of any inconsistency between this Agreement and the Protocol, this Agreement prevails.


 




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In
witness hereof, the parties have caused this Agreement to be executed as of respective dates written below.


 


Signed
on behalf of the Sponsor


 


	Signed:	/s/
    Joel Latham	 
	Name:	Joel
    Latham	 
	Position:	CEO	 
	Date:	25 March 2021	 


 


Signed
on behalf of the Institution


 


	Signed:	/s/
    Dr Campbell Thomson	 
	Name:	Dr
    Campbell Thomson	 
	Position:	Director,
    Office of Research Enterprise	 
	Date:	6 April 2021	 


 


The
Principal Investigator acknowledges this Agreement and understands the obligations it imposes.


 


Acknowledged
by the Principal Investigator


 


	Signed:	/s/ Dr Jennifer Walsh	
	Name:	Dr Jennifer Walsh	 
	Position:	Director, Centre for Sleep Science	 
	Date:	6 March 2021	 



 










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Schedule
1


Key
Information


 


	Study
    Name:	Dose
                                            finding crossover trial investigating the effect of dronabinol combined with acetazolamide
                                            on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA)

	 	 
	Study
Site/s:
	Centre
                                            for Sleep Science, University of Western Australia



	 	

                                                                                 

                                                                                 

	 	 
	Target
number of Study Participants:
	Minimum:
12

     

    Maximum:
    12

	 	 
	Recruitment
    Period:	Start:
    26/MAR/2021	End:	28/MAY/2021
	 	 	 	 
	Principal
    Investigator Name:	Dr
    Jennifer Walsh
	Address:
	Centre
for Sleep Science,

	 	35
Stirling Hwy, Crawley

	 	State:
Western Australia
	 	P/code:
6009

	 	 	 	 
	Reviewing
HREC:
	Alfred
                                            Health Human Research Ethics Committee

	Equipment
provided by Sponsor:
	NIL

	 	 
	 	 
	 	 
	 	 
	Software
provided by Sponsor:
	NIL

	 	 
	 	 
	 	 
	 	 
	Investigational
Product:
	Dronabinol

	 	Acetazolamide

	 	 


 






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Schedule
2


Payments


 


[***] 


 









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Payments


 


Study
Site Activities


 


	Activity	Cost
    ($AUD)
	 
	

    All
    fees include

    30% overhead

    charge (exclusive GST)

	The
Site Start Up Fee of will be paid upon the completion of the Site Initiation Visit. This fee includes;

     

    - Protocol
    & IB review

     

    - Negotiating
    and execution of CTRA & study budget

     

    - Pre-Study
    Site Visit

     

    - Completion
    & execution of Regulatory Documentation

     

    - HREC
    and RGO review and submission

     

    - Site
    Initiation Visit including Protocol, Product and GCP Training

     

    - Set
    Up of Invoicing and Administration Costs
	[***]

	The
Sponsor supported salary of site staff Fee will be paid upon completion of the Site Initiation Visit. This payment will support
the employment and allocation of staff to the study for purposes of pre-screening, screening, financial management:

     

    Research
    Coordinator for 2.5 months at 0.75 FTE & 1 month at end of trial 0.25 FTE for close out

     

    Research
    Assistant - to assist recruitment at $75 per hour - 22.5 hours/week for 6 weeks

     

    administrative
    support at $40 per hour - 7.6hours/week for 1 month

     

    finance
    management 4 hour per month @$95 per hr for 6 months
	 

     

     

      

    [***]

     

    [***]

     

    [***]

     

    [***]

	Human
Research Ethics Committee (HREC) Review Fee, will be paid by the sponsor directly to the HREC for review and addition of the site
to the initial study approval.
	NA

	Amendment
Preparation Fee – Major

     

    This
    fee will be paid for the preparation of a major Protocol amendment for RGO review.
	[***]

	Amendment
Preparation Fee – Major, requiring changes to Participant Information and Consent Form (PICF)

     

    This
    fee will be paid should the major amendment requires changes to the Participant Information and Consent Form (PICF)
	[***]

	Amendment
Preparation Fee – Minor This fee will be paid for the preparation of amendments relating to Investigator Brochures (IBs), safety
documents, participant facing materials, advertising or for RGO review. 
	[***]

     






 









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	Reconsent
Fee will be paid, should an amendment require updates to the PICF and reconsenting of participants. This fee will be charged per
updated PICF and per participant.
	[***]

	Monitoring
                                                                                                                                                                                             Visit Fee will be paid, for each monitoring visit conducted by the CRO for the review of data and the overall site conduct of
                                                                                                                                                                                             the study. This fee will be paid upon review of eCRF pages, completed by the site staff in readiness for the monitoring visit and as
                                                                                                                                                                                             per contract general terms.
	[***]

	Archiving
Fee

     

    The
    one-time Archiving Fee will be paid for the archiving of study documentation, as per ICH GCP and local requirements. This fee will
    be paid upon completion of the close out visit as per satisfaction of the CRO, monitoring the study.
	[***]

	Audit
Fee

     

    The
    Audit Fee will be paid for the preparation, attendance and follow up of an Audit conducted by either a regulatory agency, such as
    the FDA or TGA or a sponsor-directed audit by an independent third-party auditor. This fee is not payable when the Audit is “for
    cause”.
	[***]

	Protocol
deviation driven by sponsor

     

    The
    Protocol deviation fee will be charged,when a protocol deviation arises in response to a situation imposed upon the site by the
    sponsor – eg. Medication shipment has not arrived and study visits are subsequently out of window and a protocol deviation is
    required. This fee will be charged per situation and on consultation with the sponsor.
	[***]

	Other
Fees;

     

    ●     MD/Clinical
Psychiatrist appointment (excluding overhead (30%)) fee, should this be deemed necessary by the trials team and in consultation and
approval by the sponsor.
	 

                                                                                                                                                                                    

                                                                                                                                                                                   [***]

	Study
                                            Close Out

     

    A
    one-time Close Out Fee will be paid upon completion and approval by the Sponsor of any outstanding data documentation (eCRFs and
    data clarifications issued) and regulatory documentation.
	[***]




 






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	Participant
transport Allowance (as noted in the budget per patient costs – see page 20)
	 
	 

    Participant
transport allowance will be paid, up to a maximum of $150 per day during each treatment period throughout the study. This may be reimbursed
on presentation of receipts to support the costs of transportation or granted as taxi vouchers. Receipts for reimbursements and taxi
vouchers must include date of travel, amount per trip.
	 

    [***]

	Breakfast
Allowance

     

    Each
    participant, that completes a sleep study will also be provided with a breakfast allowance, up to a maximum of $20 to be purchased
    at the hospital.

     

    However,
    should the site staff decide to order in breakfast for participants, the allowance per participant is $20 per sleep study.
	[***]



 


Pharmacy
and Pathology Activities


 


	Activity	Cost
    ($AUD)
	 
	

                                                                                                                                                                 All
                                            fees exclude

    GST

	A
                                             Pharmacy Setup
                                            and Study Establishment Fee will be waived for this trial.

     

    Instead,
    the sponsor will purchase a Department of Health (W.A) approved Schedule 8 refrigerated drug safe, up to a maximum value of $6000.00
    for supply and installation of the safe, for the cold storage of the investigational product. Upon the close out visit, the safe
    will remain the property of the pharmacy.
	[***]

	A
Pharmacy Administration Fee, payable in advance from SIV and annually thereafter on anniversary of SIV, per year (or part thereof).
This fee will be payable upon invoice.
	[***]

	A
Pharmacy storage of Investigational Product Fee will be payable in advance from SIV and annually thereafter on anniversary of SIV,
per year (or part thereof), for the storage of the Investigational Product in the refrigerated safe, suitable for refrigerated Schedule
8 licenced products. This fee will be payable upon invoice.
	[***]

	A
Dispensing of Investigational Product Fee, which includes accountability Fee for complex oral drugs (e.g., requiring additional statutory
recording as S8 medicine)
	[***]

	An
Investigational Product Destruction Fee will be payable should the sponsor request that IP be destroyed on-site, according to hospital
guidelines. This fee will be payable upon invoice.
	[***]

	A
Remote Monitoring Fee will be payable for each hour the Clinical Research Associate requires for the purposes of IP accountability,
should this service be requested. The IP accountability visit will be scheduled in advance and with the clinical trials pharmacist. This
fee will be payable upon invoice.

     

    Note:
    there is no additional charge for on-site monitoring. 
	[***]



	After
Hours Call Back Fee

     

    The
    After Hours Call Back Fee will be paid when IP requires preparation and dispensation outside the hours of 8am - 5pm due to
    unforeseen circumstances.
	[***]

	A
                                                                                                                                                                                             Pharmacy Close Out Fee, a one-time fee, will be payable upon the final close out visit, after all remaining or used
                                                                                                                                                                                             Investigational Product as either been returned to the sponsor or destroyed upon written notification from the sponsor, and all
                                                                                                                                                                                             pharmacy files have been returned to the site for archiving. This fee will be payable upon invoice, no later than 30 days post close
                                                                                                                                                                                             out visit.
	[***]




 






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	Pathology
Activities
	 
	A
Setup and Study Establishment Fee, a one-time fee for the quotation, set up and establishment of the trial, upon Site Initiation
Visit and payable upon receipt of an invoice.
	[***]

	Protocol
Amendment Fee will be paid for the changes to pathology activities, should the protocol amendment require. This fee will be charged
per amendment.
	[***]

	Specimen
Phlebotomy Collection and Processing Fee will be paid, per sample for the collection, handling and processing of samples, specifically
for this study.
	[***]

	Standard
Full Blood Panel Fee will be charged per sample per participant, and as mandated by the participant schedule and protocol.
	[***]

	Urea
and Electrolytes and Liver Function Testing Fee will be charged per sample per participant, and as mandated by the participant schedule
and protocol.
	[***]

	Urine
Drug Screen Fee will be charged for each drug screen performed, as mandated by the protocol
	[***]

	Note:
lab kits with supplies required for each test required will be provided by the sponsor to the site.
	

                                                                                 



 


1. General
Terms. Payee will be compensated as outlined on the attached study budget (“Budget”) for Study Participants properly
enrolled in the Study. This amount constitutes the full compensation for the work to be completed by the Institution and Principal
Investigator, including all work and care specified in the Protocol for the Study, along with all overhead and administrative
services. No compensation will be available for Study Participants enrolled in the Study in violation of the Protocol, unless
pre-approved by the Sponsor prior to enrolment. Fees for Site Start-up, HREC Review Fee and Sponsor Supported Salary of Site Staff
Fee are fixed, non-cancellable, non-refundable cost payable on receipt of a valid tax invoice. At the time of the study completion
unspent funds will remain the property of the Centre for Sleep Science.


 






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2. Payment
Terms. Payments for each Study Participant will be made in Australian Dollars (AUD) quarterly and based on CRF data entered by
Institution and/or Principal Investigator supporting enrolled Study Participant visitation. Payments will be made for completed
visits and treatment related costs in accordance with the Budget, unless otherwise noted in the Agreement. Monitoring will occur
approximately every 6 weeks based on Study Site enrolment and completion of data entry. All participant visit data must be entered
within five (1) business days and queries must be resolved within five (5) business days of receipt by Institution and/or Principal
Investigator any time during the Study. Payee must submit any final valid tax invoices within sixty (60) calendar days after the
close-out visit of the Study at the Institution. Any invoices received thereafter may not be paid. Payee will have ninety (90)
calendar days after the date of the close-out visit of the Study at the Institution to dispute any payment discrepancies or missing
payments.


 


3. Non-Procedural
Costs. Payee will be paid for additional non-procedural costs that are pre-approved by Organisation/Local Sponsor as set forth in
the Budget. To request payment for such costs, Payee will remit valid tax invoice to Local Sponsor or its designee with documentation
and receipts substantiating agreed-upon pass-through expenses. Any non-procedural pass-through expenses will be invoiced only in the
amount actually incurred with no mark-up, up to the maximum amounts shown in the Budget.


 


4. Final
Payment. At the conclusion of the Study, all CRFs and Study-related documents will be promptly made available for Organisation/Local
Sponsor review. The final payment (“Final Payment”) will be paid once: all CRFs have been completed and received; data queries
have been satisfied; all Investigational Product is returned; and all close out issues are resolved, and procedures completed, including
final HREC and/or Regulatory Authority notification, if applicable. All queries must be resolved within five (5) business days of receipt
by Institution and/or Principal Investigator. Local Sponsor or its designee will perform final reconciliation of all payments made to
date against total amount due and will promptly pay Payee amounts remaining unpaid, if any. Payee will promptly reimburse Local Sponsor
any unearned or overpaid amounts previously paid to Payee within sixty (60) calendar days of notification by Local Sponsor or designee.


 


 5. Taxes.




 


1) Payments
shown in the Budget do not include GST. If the Payee is GST registered, and if GST is required under the GST Law, GST should be added
and shown on the invoice by the Payee at the applicable GST rate, along with Payee’s GST registration number.


 


2) Payee
acknowledges and agrees that it is solely responsible for the payment of any and all contributions and taxes imposed by any applicable
authority with respect to or measured by compensation paid to Payee under this Agreement. Local Sponsor/designee will not be responsible
for the withholding or payment of any such required contributions or taxes. Payee accepts full responsibility for reporting all payments
received, under this agreement, to the relevant taxation authorities as required by local regulations.


 


6.
Screen Failures. A Screen Failure is a consented Study Participant who fails to meet the screening visit criteria and is thus
not eligible for enrolment into the Study (“Screen Failure”). Documentation to support rationale for screen failure must
be presented to the monitor prior to screen failure reimbursement. Screen Failures will be reimbursed, as outlined in the Budget.


 






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7. Necessary
Procedures. Payee will be reimbursed for valid necessary visits and procedures not covered under the Budget. Payment for any necessary
procedure due to Study Participant safety will be reimbursed at the agreed upon unit cost in the Budget, if available, or if there is
no such unit cost in the Budget, Payee will be compensated based on actual costs incurred by Institution and Principal Investigator and
will require a separate valid tax invoice with documentation for the medical necessity of the procedure. Where practicable, Local Sponsor
or Organisation’s prior written consent will be obtained, unless it will compromise the integrity of the Study or affect Study
Participant safety, in which case Local Sponsor or Organisation will be notified as soon as practicable after the fact.


 


8. Payee.
The Institution has authorised Valerie Mandel on behalf of The Centre for Sleep Science to be responsible for financial administration
of the Study funds as its Payee. The Parties acknowledge that Payee is authorised to receive and administer all Study payments on behalf
of the Institution and that the Sponsor’s only payment obligation under this Agreement is to the Payee. Institution releases Sponsor
from any obligation or liability related to handling or disbursement of the funds by Payee.


 


 9. The payments will be made to the following Payee and address:




 


	Payee
    Name	Valerie
    Mandel
	Payee
    Address	Office
    of Research

    Research
    Grants and Contracts Mailbag M459

    35
    Stirling Highway Crawley, WA

    6009

	Australian
    Business Number	37
    822 817 280
	Recipient
    Address	35
    Stirling Highway

                                                                                                                                                                                                    Crawley, WA

    6009

	Recipient
    Phone Number	[***]
	Recipient
    Email	[***]
	Payee
    Bank Account Details:
	Bank
    Name	Westpac
    Banking Corporation
	Bank
    Address	University
    Campus

                                                                                                                                                                                                    UWA Guild Village

                                                                                                                                                                                                    Hackett Drive

                                                                                                                                                                                                    CRAWLEY, WA

    6009

	Account
    Name	The
    University of Western Australia
	BSB
    Number	[***]
	Bank
    Account Number	[***]
	SWIFT
    Code	[***]


 


 10. Invoices. All invoices must be issued and forwarded to the following as instructed:




 


Email:
accounts@incannex.com.au and rosemarie@incannex.com.au


 


Sponsor
Address;


Incannex Healthcare Ltd


Unit 207, 11 Solent Circuit


Norwest,
2153


New South Wales


 




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Australia


 


ABN
93 096 635 246


 


All
payment related queries may be directed to:


 



Email: rosemarie@incannex.com.au


 


Each
invoice must contain: (1) Organisation’s name, (2) Protocol number, (3) Study code, (4) Principal Investigator’s name,
(5) a summary of the reimbursement to be made in compliance with the Budget, and (6) if the Payee is GST registered, the Australian
Business Number (ABN).


 


Payee
will not receive any payments for pass through expenses whereby Payee has failed to produce actual copy invoices or other documentation
clearly substantiating that the expenditures were actual, reasonable, and verifiable in the amount submitted for compensation.


 


Suggested
High Level Subject matter


 






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Schedule
3


Form
of Indemnity for Clinical Trials


 


The
Sponsor agrees to execute and deliver to the Institution, as necessary, an indemnity in the form of the Medicines Australia Standard
Form of Indemnity for Clinical Trials without amendment.


 


Indemnity
for Clinical Trials; HREC Review Only and Standard Forms have been provided as separate documents.


 






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Schedule
4


Insurance
Arrangements


 





 






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Schedule
5


Guidelines
for Compensation for Injury Resulting from Participation in a Company-Sponsored Trial


 


Copy
available online at:


http://medicinesaustralia.com.au/issues-information/clinical-trials/indemity-and-compensation-guidelines/





 






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Schedule
6


Study
Protocol Identification


 


	 	 
	 

     

    Full
    Title:
	Dose
    finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults
    with obstructive sleep apnoea (OSA) 






	 	 
	Version
                                            Number:
	4                     
	 

	Date:	13
    / AUGUST 2020 
	List
    of Key Attachments:	NIL
    
	 	 
	 	 
	 	 
	 	 


 






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Schedule
7 

Special Conditions


 


There
are no special conditions. 



 


This
page is blank.


 









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