Document:

Exhibit 4.5

 

 

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:	Alfred Health a body corporate established under the Health
    Services Act 1988 (Vic) of Commercial Road, Melbourne, 3004 or Alfred Health

	Address:	Commercial Road, Melbourne,
    Victoria, 3004
	ABN:	27 318 956 319
	Contact for Notices:	Professor Terence O’Brien
	Fax for Notices:	[***]

	Phone Number:	[***]

 

	Name of Sponsor:	lncannex
    Healthcare Ltd
	Address:	3 Fir Street
	Dingley Village, 3172

    Victoria Australia

	ABN:	93 096 635 246
	Contact for Notices:	Mr Joel Latham
	Fax for Notices:	NIA
	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

 

    	Protocol Number: IHLOSAPOC1
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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;

 

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		(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.

 

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)/lnternational 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 breeders rights,
registered designs, registered and unregistered trade marks, 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;

 

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

 

		(9)	references to a party include its Personnel.

 

		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;

 

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		(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.

 

		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.

 

		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.

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 11 of 38 

    

    

 

		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

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 12 of 38 

    

    

 

		(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.

 

		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.

 

    	Protocol Number: IHLOSAPOC1
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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 13 of 38 

    

    

 

		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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 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 14 of 38 

    

    

 

		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.

 

    	Protocol Number: IHLOSAPOC1
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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 15 of 38 

    

    

 

		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.

 

		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.

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 16 of 38 

    

    

 

		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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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 17 of 38 

    

    

 

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:		 
	Name:		 
	Position: 		 
	Date:		 

 

Signed on behalf of the Institution  

 

	Signed:		 
	Name:		 
	Position: 	 	 
	Date:		 

 

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

 

Acknowledged
by the Principal Investigator  

 

	Signed:	 	 
	Name:	 	 
	Position: 		 
	Date:		 

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 18 of 38 

    

    

 

	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:

	The Alfred Hospital

 

	Target number of Study Participants:	Minimum: 12
	 	 
	 	Maximum: 12
	 	 
	Recruitment Period: 	Start: 07/SEP/2020                                  End: 01/MAR/2021
	 	 
	Principal Investigator Name:	Professor Terence O’Brien
	 	 
	Address:	Department of Neurosciences,
                                            4th Floor, Centre Block

	 	 
	 	The Alfred Hospital, 55 Commercial Road, Melbourne
	 	 
	 	State: Victoria, Australia                                 
    P/code: 3004

 

	Reviewing HREC:	Alfred Health Human Research Ethics Committee
	 	 
	Equipment provided by Sponsor:	NIL
	 	 
	 	 
	 	 
	Software provided by Sponsor:	NIL
	 	 
	 	 
	 	 
	Investigational Product:	Dronabinol
	 	 
	 	Acetazolamide

	 	 
	 	 

 

    	Protocol Number: IHLOSAPOC1
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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 19 of 38 

    

    

 

Schedule 2

Payments

 

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

     

     

     

    [***]

     

	 	 	[***]	

[***] 
	
    

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

 

	
    [***]

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

 

    	Protocol Number: IHLOSAPOC1
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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 20 of 38 

    

    

 

Payments

 

Study Site Activities

	
    Activity
	
    [***]

	
     

    The Site Start Up Fee of will
    be paid upon the completion of the Site Initiation Visit.
	
     

    [***]

	
     

    Study Site Administration Fee will
    be paid quarterly, starting from the Site Initiation Visit or Pre-screening (whichever occurs

    first), until the Close out Visit.
	[***]

	
     

    The Site Training
Fee, a one-off fee, will be payable on the completion of all training required for the study conduct, including eCRF training. This
payment is per system trained on per investigator and co-ordinator.
	
     

    [***]

	
     

    Human
    Research Ethics Committee (HREC) Review Fee, a one-time fee, for the review of the initial submission package for the trial,
    will be payable upon receipt of invoice
	
     

    [***]

	
     

    Pre-Screening Fee

     

    The Pre-Screening Fee is paid
    for the pre-screening activities performed by the Institution to identity potential Participants by assessing medical records and databases.
    Pre-screening activities will be documented on a log to support pre-screening tasks. This fee is paid annually from the first anniversary
    of the

    SIV.
	[***]
	
     

    Amendment Preparation Fee - Major

     

    This fee will be paid for the preparation
    of a major Protocol amendment or Participant Information and Consent Form (PICF) for RGO review.
	[***]
	
     

    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.
	
     

    [***]

	
     

    Amendment Preparation Fee -
    Major, within one month of RGO approval

     

    This fee will be paid if a Protocol
    and/or PICF is prepared and submitted to the Alfred RGO within and up to one calendar month after initial RGO approval.
	[***]

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 21 of 38 

    

    

 

	
     

    Amendment Preparation Fee -
    Minor, within one month of RGO approval

     

    This fee will be paid
    if an IBs, safety document, participant facing material, advertising or changes to site staff become available and are submitted
    to the Alfred RGO within and up to one calendar month after initial RGO approval.
	 

                                                                                [***]

	
     

    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.
	
     

    [***]

	
     

    Archiving Fee

     

    The one-time Archiving Fee will
    be paid for the archiving of 2 boxes as per ICH GCP and local requirements. This Fee also includes electronic scanning and secure destruction
    at the end of the archiving period.
	
     

    [***]

	
     

    Archiving Fee - Additional Box

     

    The Archiving Fee -Additional
    Box Fee will be paid for any boxes in addition to the original 2 boxes. Prior Sponsor approval is required.
	
     

    [***]

	
     

    Archiving - Box Retrieval

     

    The Archiving - Box Retrieval
    Fee will be paid if a storage box requires retrieval from the archiving location.
	
     

    [***]

	
     

    Audit Fee

    The Audit Fee will be paid for
    the preparation, attendance and follow up of an Audit. This fee is capped at three (3) business days. This fee is not payable when the
    Audit is “for cause”.
	
     

    [***]

	
     

    Participant transport Allowance

     

    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.
	
     

     

    [***]

	
     

    Participant Sleep Study Allowance

     

    Participants will be reimbursed
    $25 per hour up to a maximum of 8 hours for their time spent at site performing each sleep study.
	
     

     

    [***]

	
     

    Breakfast Allowance

     

    Each participant, that completes
    a sleep study will also be provided with a breakfast allowance, up to a maximum of $25 to be purchased at the hospital.
	
     

    [***]

 

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 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 22 of 38 

    

    

 

Pharmacy
and Pathology Activities

 

	Activity	
    Cost ($AUD)

     

    All fees exclude

    GST

	
     

    A Pharmacy Setup and Study
    Establishment Fee will be payable upon the attendance and completion of the Site Initiation Visit. This fee will be payable upon invoice.
	
     

    [***]

	
     

    A Pharmacy Annual Fee, will be payable for the management
    and administration of the study. This fee will be payable upon invoice.
	[***]
	
     

    A Pharmacy storage of
    Investigational Product Fee will be payable for the storage of the IP in a 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, will be payable for every dispensing of IP for participants and post
    accountability visit and with the monitoring fee
	
     

    [***]

	
     

    An Investigational Product
    Accountability Fee is incorporated into the dispensing fee.
	 

                                                                                [***]

	
     

    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. An initial
amount of Six Hundred and Ninety Australian Dollars (690 AUD) will be paid for the first three (3) hours. After the first three (3) hours,
this fee will be charged at the rate of One Hundred and Fifty-Five Australian Dollars (155 AUD) per hour.
	
     

    [***]

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 23 of 38 

    

    

 

	
     

    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.
	
     

    [***]

	
     

    Pathology Activities
	 

                                                                                [***]

	
     

    A Protocol review and SSA completion
    Fee, a one-time fee, will be payable upon completion of the Site Initiation Visit and upon invoice.
	
     

    [***]

	
     

    An Establishment Fee, a
one-time fee for the establishment of the trial, upon Site Initiation Visit and payable upon receipt of an invoice.
	
     

    [***]

	
     

    Test or service
    fee
	
     

    [***]

	
     

    Standard HAEM panel
	
     

    [***]

	
     

    Standard BIOCHEMISTRY panel
	
     

    [***]

	
     

    Urinalysis
	
     

    [***]

	
     

    Urine pregnancy test
	
     

    
[***]
	
     

    Specimen shipping, per shipment
	
     

    [***]

	
     

    Health Information Services

	Retrieval fee for paper medical records (per volume) from onsite storage	
    [***]

	Retrieval fee for paper medical records (per volume) from external storage	
    [***]

	Registration Fee, per participant	
    [***]

	Permanent retention (per volume) of medical records for research	
    [***]

	ICD10 Diagnosis database participant information search (per search)	
    [***]

 

		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.

 

As indicated
below (Point 8), the payee of these funds is Monash University (“Payee”), which is a payment administrator and is not party
to this Agreement. Organisation’s or Local Sponsor’s only payment obligation under this Agreement is to pay Monash University. Administration
of funding by Payee on behalf of Institution is governed by a separate agreement between those entities. Institution releases Organisation
and Local

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 24 of 38 

    

    

 

		2.	Payment Tenns. 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. For each payment, including any Screen Failures (as defined below) that may be payable
under the terms of this Agreement, Payee will be paid the total amount earned, less 10%, for the Final Payment (hereinafter defined).
Monitoring will occur approximately every 8 weeks based on Study Site enrolment and completion of data entry. All 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 thirty (30) calendar days after the close-out visit of the Study at the Institution. Any invoices received
thereafter may not be paid. Payee will have sixty (60) 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 thirty (30) 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”). Screen Failures
will be reimbursed, if at all, as outlined in the Budget.

 

		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.

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 25 of 38 

    

    

 

		8.	Payee. The Institution has authorised Monash University 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	Monash University
	Payee Address	211 Wellington
    Road, Mulgrave, Victoria, Australia
	Australian Business Number	12 377 614
    012
	Recipient Address	
    Receivables and Revenue Accounting

Level 4, 211 Wellington Road

    Mulgrave, VIC, 3170

	Recipient Phone Number	[***]

	Recipient Email	[***]

	 	 
	Payee Bank Account Details:
	Bank Name	Westpac Banking Corporation
	Bank Address	
    Campus Centre, Clayton Campus,

    Monash University, Victoria, 3800,

    Australia

	Account Name	Monash University General Account
	BSB Number	[***]
	Bank Account Number	[***]
	SWIFT Code	[***]
	IBAN	[***]
	Duns Number	[***]

 

Notification of all payments by EFT/direct
credit made under this Agreement will be communicated to the Executive Officer at the following address:

 

Monash: M51007 - Department of Neuroscience/Van Cleef/Roet
Centre for Nervous Diseases - Research

PO Box 315 Prahran 3181

The Alfred Hospital, 55 Commercial Rd, Vic
3004

Telephone No.: +[***]

E-Mail Address: [***]

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 26 of 38 

    

    

 

The notification of all payments made
under this Agreement will be accompanied with documentation of the calculation of each payment. The documentation will specify:

 

		●	The Human Research Ethics Committee (HREC) project number

 

		●	The Principal Investigator’s name;

 

		●	What the payment is being made for:

 

		●	The number of participants who have completed particular
milestones; and

 

		●	Detail of any partial payments, or any other information
relevant to the calculation of the payment by Neuroscience Trials Australia.

 

	*	Copies of all payment notices will be sent to the attention
of the Management Accountant - Research at the following address:

 

Monash: M51007 - Department of Neuroscience/Van Cleef/Roet
Centre for Nervous Diseases - Research

PO Box 315 Prahran 3181

55 Commercial Rd, Vic 3004

Telephone No.: [***]

Facsimile No.: [***]

E-Mail Address: [***]

 

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

 

Email:

 

Sponsor Address;

 lncannex Healthcare
Ltd

3 Fir Street, Dingley Village, VIC 3172

 Australia

 

ABN 93 096 635 246

 

All payment related queries may be directed to:

 

Email: [***]

 

Each invoice must contain: (1)
Organisation’s name, (2) Protocol number, (3) Study code, (1) 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

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 27 of 38 

    

    

 

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 on following pages.

  

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 28 of 38 

    

    

 

MEDICINES AUSTRALIA FORM OF INDEMNITY FOR CLINICAL
TRIALS

HREC REVIEW ONLY

 

For use where the Indemnified Party Is providing ethical review for
a multicentre clinical Study where the ethical review will be adopted by hospitals, institutions or sites that are independent from the
Indemnified Party, OR as a Reviewing HREC for a single centre study at a hospital or institution that is independent from the Indemnified
Party.

 

NOTE there is a different Form of Indemnity for use where the Indemnified
Pany is providing premises for the conduct of the Study and HREC Review, or is providing premises only [The STANDARD Form of Indemnity]

 

This Form has been developed by Medicinos
Australia and is an adaptation of the form used by The Association of the British Pharmaceutical Industry (ABPI), for use in
Australia It is to be regarded as the basis for agreements between pharmaceutical companies sponsoring clinical studies and the
institution that has oversight of the study to be conducted. Non-members of Medicinos Australia are encouraged to usethis Form of
Indemnity.

 

		To:	Alfred Heatlh Human Research Ethics, 55 Commercial Rd, Melbourne Victoria 3004 Austrolia, or Alfred
Health ABN 27 318 956 319 (“the Indemnified Party’’)
	 	 	 
	 	From:	lncannex Hoalthcare Ltd
3 Fir Street Dingley Village, Victoria 3172 Australia ABN 93 096635 246 (“the Sponsor’’)
	 	 	 
	 	Re:	Clinical Study No. IHLOSAPOC1: Dose finding crossover trial investigating the effect of dronabinol combined
with acotazolamide on Apnoea Hypopnea Index (AHI) In adults with obstructive sleep apnoea (OSA)

 

 

		1.	The
                                            Indemnified Party agrees to participate in the above sponsored study (“the Study”)
                                            Involving patients of The Alfred Hospital (“the Participants”)
                                            to be conducted by Professor Terence O’Brien (“the lnvestigator”)
                                            in accordance with the above referenced protocol, as amended in writing from time to time
                                            with the agreement of the Sponsor and the Indemnified Party (“the Protocol”).
                                            The Sponsor confirms that It is a term of Its agreement(s) with each hospital or Institution
                                            participating In the Study that the Investigator shall obtain all necessary approvals from
                                            the Indemnified Party’s human research and ethics committee (“HREC”).

 

		2.	The Indemnified
                                            Party agrees to participate by making its HREC available lo provide review, approval and
                                            oversight of the conduct of the Study in accordance with the requirements of the NHMRC
                                            National Statement on Ethical Conduct in Human Research.

 

		3.	In
consideration of such participation by the Indemnified Party, subject lo paragraph 4,
the Sponsor Indemnifies and holds harmless the Indemnified Pany and its employees, agents and members of and advisors to its HREC
In respect of and against all claims and proceedings (including any settlements or ex gratia payments made with the consent
of the parties hereto and reasonable legal and expert costs and expenses) made or brought (whether successfully or otherwise) by or on
behalf of Participants (including their dependants and children injured in utero through the participation of the child’s mother
or father in the Study) against the Indemnified Party or any of its employees, agents or members of and advisors to its HREC for personal
injury (including death) to Participants (and children injured in utero through the participation of the child’s mother or father
in the Study) arising out of or relating to the administration and/or use of the product(s) under investigation or any clinical
intervention or procedure provided for or required by the Protocol to which the Participants would not have been exposed
but for the participation of the Participants in the Study.

 

Medicines Australia Form of Indemnity• HREC
Review ONLY version 1 October 2012

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 29 of 38 

    

    

 

		4.	The above indemnity by the Sponsor will not apply to any such
claim or proceeding referred to in paragraph 3:

 

		(1)	to the extent that such personal injury (including death) is
caused by the negligent or wrongful acts or omissions or breach of statutory duty of the Indemnified Party or any of its employees, agents
or members of or advisors to the HREC;

 

		(2)	unless as soon as reasonably practicable following
receipt of notice of such claim or proceeding, the Indemnified Party notifies it to
the Sponsor in writing and at the Sponsor’s request, and cost, has permitted the Sponsor to
have full care and control of the claim or proceeding using legal representation of its own choosing; or

 

		(3)	if the Indemnified Party, its employees, agents, or members
of and advisors to its HREC have made any admission in respect of any such claim or proceeding or taken any action relating to any such
claim or proceeding prejudicial to the defence of any such claim or proceeding without the written consent of the Sponsor. Such consent
will not be unreasonably withheld. This condition will not be treated as breached by any statement properly made by members of and advisors
to the HREC in connection with the operation of the Indemnified Party’s internal complaint procedures, accident reporting and quality
assurance procedures or disciplinary procedures or where such statement is required by law.

 

		5.	The Sponsor will keep the Indemnified Party and its legal advisers
fully informed of the progress of any such claim or proceeding, consult fully with the Indemnified Party on the nature of any defence
to be advanced and not settle any such claim or proceeding without the written approval of the Indemnified Party which approval is not
to be unreasonably withheld.

 

		6.	Without prejudice to the provisions of paragraphs 4(2) and 4(3),
the Indemnified Party will use reasonable endeavors to inform the Sponsor promptly of any circumstances of which it has knowledge and
which may reasonably be thought likely to give rise to any such claim or proceeding and will keep the Sponsor informed of developments
in relation to any such circumstances even where the Indemnified Party decides not to claim indemnity from the Sponsor. Likewise. the
Sponsor will use reasonable endeavors to inform the Indemnified Party of any such circumstances and will keep the Indemnified Party informed
of developments in relation to any such claim or proceeding made or brought against the Sponsor alone.

 

		7.	The Sponsor and the Indemnified Party will each give to the
other such help as may reasonably be required for the efficient conduct and prompt handling of any claim or proceeding by or on behalf
of Participants (including their dependants and children injured in utero through the participation of the child’s mother or father in
the Study).

 

Medicines Australia Form of Indemnity - HREC Review
ONLY version 1 October 2012

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 30 of 38 

    

    

 

		8.	Without prejudice to the foregoing, if injury is suffered by a
Participant while participating in the Study, the Sponsor agrees to adhere to the “Guidelines for Compensation for Injury Resulting
From Participation in a Company-sponsored Clinical Trial” published by Medicines Australia and will request the Investigator to
make clear to the Participants that the Study is being conducted subject to those Guidelines.

 

		9.	For the purpose of this indemnity, the expression “agents”
is deemed to include, but is not limited to any health professional providing services to the Indemnified Party under a contract for
services or otherwise

 

		10.	This
                                            indemnity will be governed by and construed in accordance with the laws applicable in the
                                            State or Territory in which the Indemnified Party is established.

 

DATED the            day of          In the year

 

SIGNED by a duly authorised representative
of the Sponsor who certifies that they have authority to sign on behalf of the Sponsor

 

	 	
	 	(Signature)
	 	 
	 	
	 	(Name)
	 	 
	 	
	 	(Position)

 

SIGNED by the Chief Executive or
a duly authorised representative of the Indemnified Party

 

	 	
	 	(Signature)
	 	
	 	 
	 	(Name)
	 	
	 	 
	 	(Position)

 

Medicines Australia
Form of Indemnity - HREC Review ONLY version 1 October 2012

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 31 of 38 

    

    

 

MEDICINES AUSTRALIA FORM
OF INDEMNITY FOR CLINICAL TRIALS

STANDARD

 

For use where the Indemnified Party is
providing premises for the conduct of the Study and HREC Review, OR is providing premises only.

 

		To:	Alfred Health a body corporate established under the Health Services
                                            Act 1988 (Vic) of Commercial Road, Melbourne, 3004 Victoria Australia or Alfred Health, ABN
                                            27 318 956 319 in which the Study is to be conducted (“the Indemnified Party”)

 

		From:	lncannex Healthcare
                                            Ltd 3 Fir Street Dlngley Village, 3172 Victoria Australia ABN 93 096 635 246 (“the
                                            Sponsor”)

 

		Re:	Clinical Study No. IHLOSAPOC1: Dose Finding Crossover Trial Investigating
                                            the Effect of Dronabinol Combined with Acetazolamide on Apnoea Hypopnea Index (AHI)
                                            in Adults with Obstructive Sloop Apnoea (OSA)

 

	1.	The Indemnified
Party agrees to participate in the above sponsored study (“the Study”) involving patients or the Indemnified Party (“the
Participants”) to be conducted by Professor Terence O’Brien (“the Investigator”) in accordance with the above referenced
protocol, as amended In writing from time to time with the agreement of the Sponsor and the Indemnified Party (“the Protocol”).
The Sponsor confirms that is is a term of its agreement with the Indemnified Party that the Investigator shall obtain all necessary approvals
from a relevant and appropriate Human Research Ethics Committee (“HREC”) and the Indemnified Party, where appropriate. 

 

	2.	The Indemnified Party agrees to participate by allowing the Study to be undertaken on its premises or
as otherwise agreed, utilising such facilities, personnel and equipment as may reasonably be required lor the Study.
	 	 
	3.	In consideration or such participation by the Indemnified Party, subject
lo paragraph 4, the Sponsor indemnifies and holds harmless the Indemnified Party and its employees. agents, and ii the HREC is the ethics
committee of the Indemnified Party, the members of and advisors to its HREC (collectively the “Indemnified”), in respect of
and against all claims and proceedings (including any settlements or ex gratia payments made with the consent of the parties hereto and
reasonable legal and expert costs and expenses) made or brought (whether successfully or otherwise) by or on behalf of Participants (including
their dependants and children injured in utero through the participation
of the child’s mother or father in the Study) against any of the Indemnified lor personal injury (including death) to Participants (and
children injured in utero through the participation of the child’s
mother or father in the Study) arising out or or relating to the administration and/or use of the product(s) under investigation or any
clinical intervention or procedure provided for or required by the Protocol to which the Participants would not have been exposed but
lor the participation or the Participants in the Study. 

 

Medicines Australia Fom, or Indemnity Standard version 1 October 2012

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 32 of 38 

    

    

 

		4.	The above
                                            indemnity by the Sponsor will not apply to any such claim or

 

		(1)	to the extent that such personal injury (including death) is caused by the negligent
or wrongful acts or omissions or breach of statutory duty of the Indemnified;

 

		(2)	to the extent that such personal injury (including death) is caused by the failure of the Indemnified
Party, its employees, or agents to conduct the Study strictly in accordance with the Protocol;

 

		(3)	unless as soon as reasonably practicable following receipt of notice of such claim or proceeding, the
Indemnified Party notifies it to the Sponsor in writing and at the Sponsor’s request, and cost. has permitted the Sponsor to have full
care and control of the claim or proceeding using legal representation of its own choosing; or

 

		(4)	if any of the Indemnified have made any admission in respect of any such claim or proceeding or taken any action relating to any
                                                               such claim or proceeding prejudicial to the defence of any such claim or proceeding without the written consent of the Sponsor. Such
                                                               consent will not be unreasonably withheld. This condition will not be treated as breached by any statement properly made by any of
                                                               the Indemnified In connection with the operation of the Indemnified Party’s Internal complaint procedures, accident reporting
                                                               and quality assurance procedures or disciplinary procedures or where such statement is required by law.

 

		5.	The Sponsor will keep the Indemnified Party and its legal advisers
fully informed of the progress of any such claim or proceeding, consult fully with the Indemnified Party on the nature of any defence
to be advanced and not settle any such claim or proceeding without the written approval of the Indemnified Party which approval is not
to be unreasonably withheld.

 

		6.	Without prejudice to the provisions of paragraphs 4(3) and 4(4),
the Indemnified Party will use reasonable endeavors to inform the Sponsor promptly of any circumstances of which it has knowledge and
which may reasonably be thought likely to give rise to any such claim or proceeding and will keep the Sponsor informed of developments
in relation to any such circumstances even where the Indemnified Party decides not to claim indemnity from the Sponsor. Likewise, the
Sponsor will use reasonable endeavors to inform the Indemnified Party of any such circumstances and will keep the Indemnified Party informed
of developments in relation to any such claim or proceeding made or brought against the Sponsor alone.

 

		7.	The Sponsor and the Indemnified Party will each give to the
other such help as may reasonably be required for the efficient conduct and prompt handling of any claim or proceeding by or on behalf
of Participants (including their dependants and children injured in utero through the participation of the child’s mother or father
in the Study).

 

		8.	Without prejudice to the foregoing, if Injury is suffered by
a Participant while participating in the Study, the Sponsor agrees to adhere to the “•Guidelines for Compensation for Injury Resulting
From Participation In a Company-sponsored Clinical Trial” published by Medicines Australia and will request the Investigator to
make clear to the Participants that the Study is being conducted subject to those Guidelines. and children injured in utero
through the participation of the child’s mother or father in the Study).

 

Medicines Australia
Form of Indemnity Standard version 1 October 2012 

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 33 of 38 

    

    

 

		8.	Without prejudice to the foregoing, if injury is suffered by
a Participant while participating in the Study, the Sponsor agrees to adhere to the “Guidelines for Compensation for Injury Resulting
From Participation in a Company-sponsored Clinical Trial” published by Medicines Australia and will request the Investigator to
make clear to the Participants that the Study is being conducted subject to those Guidelines.

 

		9.	For the purpose of this indemnity, the expression “agents”
is deemed to include, but is not limited to any health professional providing services to the Indemnified Party under a contract for
services or otherwise

 

		10.	This indemnity will be governed by and
                                                                                                                                       construed in accordance with the laws applicable in the State or Territory in which the Indemnified Party is established.

 

DATED the          day of        in the year

 

SIGNED by a duly
authorised representative of the Sponsor who certifies that they have authority to sign on behalf of the Sponsor

 

	 	
	 	(Signature)
	 	 
	 	
	 	(Name)
	 	 
	 	 
	 	(Position)

 

SIGNED by the Chief Executive or
a duly authorised representative of the Indemnified Party

 

	 	
	 	(Signature)
	 	
	 	 
	 	(Name)
	 	
	 	 
	 	(Position)

 

Medicines Australia
Form of Indemnity- HREC Review ONLY version 1 October 2012

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 34 of 38 

    

    

 

Schedule 4

Insurance Arrangements

 

 

Certificate
of Currency

 

Clinical
Trials Insurance Policy

 

	Policy
    No:	AUS20980675A
	 	 
	Name
    Insured:	lncannHealthcare
    Lill
	 	 
	Specified
    Clinical Trial(s):	Dose
    Finding:Crossover Trial Investigating:the Effect of Dronabinol Combined with Acetezolamide on Apnoea Hypopnea
    Index (AHI) in Adults with Obstructive Sleep Apnoea (OSA)
	 	 
	Protocol
    Number	IHLOSAPOO
	 	 
	Trial
    Location:	Australia
                                            (VIC, NSW, QLD, WA)

	 	 
	Period
    of lnsurance:	from
    4pm on 1 Augst 2020 to 4 pm on 1 August 2021 

	 	 
	Limit
    of Liability:	AUD
    20,000,000 any one Claim 
	 	 
	Overall
    PolicyLimit:	AUD
                                            20,000,000 in the annual aggregate any one Period of Insurance

    

    

	 	 
	Excess:
	Nil

    

	 	 
	Retroactive
    Date:	1
                                            August 2020

    

	 	 
	Extended
                                            Reporting: Period:

    
	12
                                            months (other than 72 months in respect of QLD & WA)

	 	 
	Territorial
    Limits:	Australia
                                            and New Zealand

    

	 	 
	Underwriting:

    
	Newline
    Australia Insurarce Pty Ltd on behalf of Lloyds Newline Syndicate 1218 at Lloyd’s (NWL1218)
	 	 
	Security:	 
	 	 
	Approved
                                            by:

    
	Craig.Rowsell

    

	 	 
	 	/ 	 
	 	 
	Date:	28
    July 2020

 

 

This
Certificate of Currency is current at the Date of Issue only and is issued as a matter of information only, conferring no rights
upon the holder. Coverage is always subject to policy terms, conditions, limitation, exclusions and endorsements. This Certificate
does not extend, amend or alter such coverage.

 

For
the avoidance of doubt, Named Insured may include other parties as defined in the Policy.

 

 

Newline
Australia Insurance Pty Ltd AON 81118 089651

PO
Box 16208, Collins St West, VIC 8007

(T)
03 9999 1906 (f) 03 9670 0045

(E)
admin@newlinegroup.com.au

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 35 of 38 

    

    

 

Schedule 5

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

 

Copy available online at:

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

 

 

 

 

 

 

 

 

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 36 of 38 

    

    

 

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
	 	 
	 	 
	 	 
	 	
	 	 
	 	 
	 	 
	 	 
	 	 
	 	 
	 	 

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 37 of 38 

    

    

 

Schedule 7

Special Conditions

 

There are no special conditions.

This page is blank.

 

 

 

 

 

 

 

 

 

    	Protocol Number: IHLOSAPOC1
 Site: Alfred Health
 
	 
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 38 of 38Exhibit
4.6

 

 

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

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 1 of 32

    

    

 

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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 2 of 32

    

    

 

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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 3 of 32

    

    

 

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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 4 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 5 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 6 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 7 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 8 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 9 of 32

    

    

 

	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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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 11 of 32

    

    

 

	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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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 13 of 32

    

    

 

	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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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 14 of 32

    

    

 

	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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
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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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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 16 of 32

    

    

 

	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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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 17 of 32

    

    

 

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	 

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 18 of 32

    

    

 

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

	 	 

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 19 of 32

    

    

  

Schedule
2

Payments

 

[***] 

 

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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 20 of 32

    

    

 

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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Site: University of Western Australia_FINAL
 
	
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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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	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 22 of 32

    

    

 

	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.
	[***]

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 23 of 32

    

    

 

	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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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 24 of 32

    

    

 

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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 25 of 32

    

    

 

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

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 26 of 32

    

    

 

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

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 27 of 32

    

    

 

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.

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 28 of 32

    

    

 

Schedule
4

Insurance
Arrangements

 

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 29 of 32

    

    

 

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/

 

    	Protocol Number: IHLOSAPOC1
Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 30 of 32

    

    

 

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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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 31 of 32

    

    

 

Schedule
7 

Special Conditions

 

There
are no special conditions. 

 

This
page is blank.

 

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Site: University of Western Australia_FINAL
 
	
	Medicines Australia Standard CTRA 8 March 2017 (revised)	Page 32 of 32

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