Research Services Agreement

Exhibit 4.8

 

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.

 

Research Services Agreement

 

DETAILS

 

PARTIES
Monash	Monash University (ABN 12 377 614 012), a body corporate constituted in accordance with the Monash University Act 2009 (Vic) of Wellington Road, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, Australia 3800
Contracting Party	lncannex Healthcare Ltd (ABN 93 096 635 246) of Level 39, Rialto South Tower, ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ (or its nominee)
TERM
Commencement Date	(23/11/2020]
Completion Date	(23/11/2023]
RESEARCH SERVICES
Research Services	The research services described in Annexure A
Deliverables	Psi-GAD-1 Trial Brief Progress Report: 23/05/2021 Psi-GAD-1 Trial Annual Progress Report: 23/11/2021 Psi-GAD-1 Trial Brief Progress Report: 23/05/2022 Psi-GAD-1 Trial Annual Progress Report: 23/11/2022 Psi-GAD-1 Trial Brief Progress Report: 23/05/2023 Psi-GAD-1 Trial Completion Report: 23/12/2023
Milestones	Description	Due Date
	Determine basic trial design and register trial with ANZCTR	Before 23/03/2021
	Submission of trial protocol to HREC	Before 23/05/2021
	Commence patient recruitment	Before 23/09/2021 (subject to HREC delays)
Key Personnel	▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ School of Clinical Sciences
Contracting Party Responsibilities	Not Applicable
Background IP	Monash Background IP: None Specified Contracting Party’s Background IP: None Specified Dr ▇▇▇▇▇▇▇▇▇▇’s Background IP: Outlined in Annexure B

 

 

Are Monash approvals (eg ethics/biosafety) required?	YES – Human Ethics		☐ No
PAYMENT
Fees	Invoicing date or Milestone		Amount $AUD (excl GST)
	On the listed Commencement Date		$[***]
	15 months following the listed Commencement Date		[***]
	TOTAL		[***]
Expenses	Any shortfall arising from requested changes to the budget from the Contracting Party, and any additional activities outside the scope of the budgeted research trial requested by the Contracting Party and agreed to by the Principal Investigator team. Any such expenses are payable prior to above changes or activities occurring.
CONTACT DETAILS
Address for notices	Monash address:		Contracting Party address:
	Attention:	▇▇▇▇▇▇▇▇ ▇▇ Research Manager	Attention:
	Address:	[***]	Address:	[***]
	Phone:	[***]	Phone:	[***]
	Email:	[***]	Email:	[***]
Address for invoices	As above

 

 

EXECUTED as an agreement
SIGNED for and on behalf of
MONASH UNIVERSITY by
its authorised officer:
/s/ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇
Print Name
Senior Deputy ▇▇▇▇ and Director of Research FMNHS		25-11-2020
Title		Date
SIGNED by the CONTRACTING PARTY
in accordance with section 127
of the Corporations Act 2001 (Cth):		Signature of Director
/s/ ▇▇▇▇▇ ▇▇▇▇▇▇		/s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇		▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Name of Secretary Director XXXXX):		Name of Director
27 November 2020		27 November 2020
Date		Date

 

 

Background

 

A.	The Contracting Party wishes to engage ▇▇▇▇▇▇ to perform the Research Services.

 

▇.	▇▇▇▇▇▇ agrees to perform the Research Services on the terms set out in this Agreement.

 

C.	The parties acknowledge and agree that the Contracting Party may assign or novate its rights and obligations under this Agreement to a nominee, being a subsidiary of the Contracting Party.

 

1. Definitions

 

1.	In this Agreement:

 

Agreement means this agreement, the Details, and annexures (if any);

 

Australian Sanctions Law means any law prohibiting or restricting dealings with proscribed states, persons or entities or seeking to prevent the proliferation of weapons, including but not limited to laws implementing the sanctions imposed by the United Nations Security Council.;

 

Background IP means Intellectual Property Rights owned or controlled by a Party at the Commencement Date or created or acquired independently of this Agreement, that a Party makes available for the performance of the Research Services, and includes Improvements and any Background IP specified in the Details;

 

Business Day means a weekday on which banks are open in Melbourne, Australia.

 

 

Confidential Information means information disclosed to a Party (Receiving Party) in any material form by the other Party (Disclosing Party) in relation to the Research Services which is by its nature confidential, which is designated by the Disclosing Party as confidential, or which the Receiving Party knows or ought to know is confidential, but does not include (or, as the case requires, ceases to include) information which:

 

(a)

is in the public domain at the time of disclosure;

 

(b)

is published or otherwise becomes part of the public domain through no fault of the Receiving Party;

 

(c)

was in the possession of the Receiving Party at the time of disclosure without an obligation of non-disclosure to the Disclosing Party;

 

(d)

is received from a third party without an obligation of non-disclosure;

 

(e)

is independently created by or on behalf of the Receiving Party by persons who had no knowledge of the Confidential Information; or

 

(f)

is required to be disclosed by law.

 

Controller means, in relation to a person:

 

(a)

a receiver, receiver and manager, administrator or liquidator (whether provisional or otherwise) of that person or that person’s property; or

 

(b)

anyone else who (whether or not as agent for the person) is in possession, or has control, of that person’s property to enforce an encumbrance;

 

Details mean the matters set out in the table on the front page(s) of this Agreement headed “Details”;

 

Developed IP means Intellectual Property Rights created or developed by or on behalf of Monash in the course of performing the Research Services, including the Deliverables, but expressly excluding Background IP;

 

Force Majeure Event has the meaning given to that term in clause 10.1;

 

GST means a goods and services tax imposed on the supply of goods and services (including intellectual property) under the A New Tax System (Goods and Services Tax) Act 1999 (Cth);

 

Improvements means any improvements, enhancements, modifications, adaptations, extensions, developments, mutations, application of Background IP, and all other technical advances made by or on behalf of Monash to Background IP, whether or not protected by statute, in the course of providing the Research Services;

 

 

Insolvency Event means, in respect of a Party, any one or more of the following events or circumstances:

 

(a)

a winding up, dissolution, liquidation, provisional liquidation, administration or bankruptcy;

 

(b)

having a Controller or analogous person appointed to it or any of its property;

 

(c)

being unable to pay any of its debts as and when due and payable or being deemed to be insolvent under any provision of the Corporations Act 2001 (Cth) or any other law;

 

(d)

seeking protection from its creditors under any law, entering into a compromise, moratorium, assignment, composition or arrangement with, or for the benefit of, any of its members or creditors, or

 

(e)

any analogous event or circumstance to those described in paragraphs (a) to (d) under any law,

 

unless such event or circumstance occurs as part of a solvent reconstruction, amalgamation, compromise, arrangement, merger or consolidation approved by the other party (which approval is not to be unreasonably withheld or delayed);

 

Intellectual Property Rights means all rights resulting from intellectual activity whether capable of protection by statute, common law or in equity, including copyright, discoveries, inventions, patent rights, registered and unregistered trade marks, design rights, circuit layouts, plant varieties, the right to have confidential information kept confidential and all rights and interests of a like nature, together with any and all documentation relating to such rights and interests;

 

Party means Monash or the Contracting Party and Parties means both of them;

 

Personal Information means ‘personal information’ as defined in the Privacy and Data Protection Act 2014 (Vic) and ‘health information’ as defined in the Health Records Act 2001 (Vic);

 

Research Services means the research services to be provided by Monash under this Agreement, as described in the Details;

 

Term means the term of this Agreement as set out in clause 2.

 

2.	All other capitalised expressions in this Agreement have the meanings given to them in the Details.

 

2.

Term

 

This Agreement will commence on the Commencement Date and will continue until the Completion Date, unless terminated earlier in accordance with this Agreement.

 

 

3.

Research Services

 

3.1.

Performance

 

(a)

▇▇▇▇▇▇ agrees to:

 

(i}

carry out and complete the Research Services during the Term in accordance with the terms of this Agreement, including providing the Deliverables and complying with the Milestones as set out in the Details;

 

(ii}

carry out the Research Services in accordance with all reasonable professional, scientific and ethical principles and standards;

 

(iii)

use reasonable endeavours to obtain any required Monash approvals and is not required to commence the Research Services until such approvals are obtained. If Monash approvals are unable to be obtained or obtained in a timely manner, the Parties will communicate with each other and decide whether to terminate this Agreement. If the Parties agree to terminate this Agreement under this clause, Monash will be entitled to payment for work done and Expenses incurred up to the date of termination; and

 

(iv)

use reasonable endeavours to ensure that any Key Personnel are actively involved in delivering the Research Services. Where the Key Personnel leave the employ of Monash or are unable to perform the Research Services, Monash will use reasonable endeavours to provide a replacement subject to the Contracting Party’s approval which will not be unreasonably withheld or delayed. If a suitable replacement cannot be found or is not agreed to by the Parties, the Parties will communicate with each other and decide whether to terminate this Agreement. If the Parties agree to terminate this Agreement under this clause, Monash will be entitled to payment for work done and Expenses incurred up to the date of termination, and reasonable costs necessarily incurred arising from such termination.

 

(b}

The Contracting Party acknowledges and agrees that to the extent that ▇▇▇▇▇▇ is unable to perform the Research Services, or there is a change in the scope of the Research Services, due to any act or omission of the Contracting Party or any Force Majeure Event, Monash may, acting reasonably, propose amendments to the Details and the Fees. Monash will promptly provide the Contracting Party with notice of such proposed amendments, whereupon the Parties will meet and agree on changes (if any}. If the Parties are unable to agree on the changes, then the Agreement will be terminated on a date agreed between the Parties (both acting reasonably} and Monash will be paid all Fees and Expenses up to the date of termination, including any committed Fees and Expenses.

 

3.2.	Contracting Party Responsibilities

 

(a}

The Contracting Party will comply with or perform the Contracting Party Responsibilities at its sole expense and will promptly provide Monash with any materials listed under the Contracting Party Responsibilities (Materials}, in addition to all information and assistance reasonably required to enable Monash to carry out the Research Services.

 

(b}

The Contracting Party will:

 

(i}

ensure that the Materials are accurate, complete and current;

 

(ii}

ensure that it is entitled to supply the Materials to Monash for the purpose of the Research Services;

 

 

(iii)

ensure that the use of the Materials in connection with the Research Services is lawful and all required consents, permissions or authorisations relating to such use have been obtained;

 

(iv)

be responsible for arranging for the packaging and delivery of all Materials to Monash and for all associated costs. ▇▇▇▇▇▇ will not be responsible for any damage to the Materials prior to delivery to it;

 

(v)

unless specified by written notice to Monash, ensure that the Contracting Party Materials, when used by Monash for the Research Services, are not reasonably capable of constituting a threat to safety, health, life, property or the environment; and

 

(vi)

ensure that it provides Monash all relevant information regarding the Materials, including, without limitation, information relating to the safe, secure and appropriate transportation, use, storage and disposal of the Materials.

 

4.

Payment

 

4.1.	Fees and Expenses

 

In consideration of ▇▇▇▇▇▇ performing the Research Services, the Contracting Party must pay to Monash the Fees and Expenses in the manner specified in the Details.

 

4.2.	Late Payment

 

Monash may suspend performance of the Research Services or its other obligations under this Agreement until any overdue amounts are paid. The Contracting Party will pay, if demanded, interest at a rate 2% higher than the rate fixed from time to time under the Penalty Interest Rates Act 1983 (Vic) on any amounts which the Contracting Party has not paid to Monash by the due date. Interest is to be calculated daily from the due date and will continue until the overdue amounts are paid.

 

5.

GST

 

5.1.	▇▇▇▇▇▇ shall submit invoices for amounts payable according to the Details and the Contracting Party agrees and undertakes to pay such amounts within thirty {30) days of receipt of a valid tax invoice.

 

5.2.

Any amount payable by the Contracting Party for anything supplied under this Agreement is expressed exclusive of GST. The Contracting Party will, on issue of a valid tax invoice (or other documentation required under GST laws to enable tax in-put credits to be claimed), pay Monash an additional amount equal to the GST liability payable by Monash on the supply within 30 days of the invoice.

 

6.	Intellectual Property Rights

 

6.1.	Background IP

 

(a)

Each Party agrees that it will not have any claim, ownership or interest in the other Party’s Background IP, except as specified in this Agreement.

 

 

(b)

Where Background IP is contributed by the Contracting Party, the Contracting Party grants Monash a non-exclusive, royalty-free licence for the Term to use, reproduce, communicate, modify and adapt that Background IP solely for the purpose of providing the Research Services.

 

(c)

To the extent that Improvements have been made by ▇▇▇▇▇▇ to the Contracting Party’s Background IP (Contracting Party Improvements), ▇▇▇▇▇▇ agrees that title to, and all Intellectual Property Rights (including future copyright) in the Contracting Party Improvements will automatically be transferred and assigned to the Contracting Party, encumbrance free, such transfer and assignment to be effective on payment in full of the Fees and Expenses.

 

(d)

▇▇▇▇▇▇ agrees to execute all such further documents and do all such further acts, at the Contracting Party’s expense, that are necessary to effect the assignment in clause 6.l(c).

 

6.2.	Ownership of Developed IP

 

(a)

Title to, and all Intellectual Property Rights (including future copyright) in, the Developed IP will automatically be transferred and assigned to the Contracting Party, encumbrance free, such transfer and assignment to be effective on payment in full of the Fees and Expenses.

 

(b)

▇▇▇▇▇▇ agrees to execute all such further documents and do all such further acts, at the Contracting Party’s expense, that are necessary to effect the assignment of the Developed IP to Contracting Party under clause 6.2(a).

 

(c)

Where the use of any Monash Background IP is necessary for the Contracting Party to be able to fully utilise the Developed IP, Monash will grant the Contracting Party a non-exclusive, royalty free licence, to use, reproduce, communicate, publish, adapt and exploit that Background IP in conjunction with the Developed IP to the extent necessary and solely for the purpose of utilising the Developed IP.

 

6.3.	Licence to Monash

 

(a)

The Contracting Party grants to Monash a non-exclusive, irrevocable, perpetual, free, worldwide licence to use, reproduce, communicate, publish, adapt and exploit the Developed IP solely for research, teaching and publication purposes (subject to Monash’s compliance with clause 9.2).

 

(b)

Where the use of any Background IP of the Contracting Party is necessary for Monash to be able to fully utilise the Developed IP in accordance with the licence granted to it under clause 6.3(a), the Contracting Party grants Monash a non-exclusive, irrevocable, perpetual, free, worldwide licence to use, reproduce, communicate, publish, adapt and exploit that Background IP in conjunction with the Developed IP solely for the purpose of utilising the Developed IP in accordance with clause 6.3(a).

 

 

7.	Liability, warranties and indemnity

 

7.1.	Acknowledgement

 

The Contracting Party acknowledges and agrees that:

 

(a)

while Monash will exercise reasonable care and diligence and comply with its obligations under this Agreement in carrying out the Research Services, research work is by its nature uncertain and that the outcomes of the Research Services and its ability to produce commercially useful results cannot be assured;

 

(b)

Monash makes no representation and gives no warranties that any Developed IP will be patentable;

 

(c)

Monash is not required to make enquiries or undertake patent searches to ascertain whether any Developed IP or Background IP infringes any third party Intellectual Property Rights;

 

(d)

the Developed IP is a result of experimental research and as such, the Contracting Party must use its own judgement as to the applicability and appropriateness of the Developed IP for the Contracting Party’s intended use;

 

(e)

the Contracting Party assumes sole responsibility and risk in interpreting, using, exploiting and protecting the Developed IP (including any findings, results and recommendations contained within); and

 

(f)

given the above, to the maximum extent permitted by law, subject to clause 7.7 and notwithstanding anything else in this Agreement, Monash will not be liable to the Contracting Party for any loss or damage arising from:

 

(i)

Contracting Party’s (or any of its users) use of any Developed IP (including any findings, results and recommendations contained within); or

 

(ii)

▇▇▇▇▇▇’s failure to perform work on time or within estimated costs, provided that Monash has exercised reasonable care and diligence and complied with its other obligations under this Agreement in carrying out the Research Services.

 

7.2.	Developed IP and Background IP limitation on warranty

 

Monash makes no representations and gives no warranties that the Developed IP, Monash Background IP, or any Improvements to the Contracting Party’s Background IP when used by the Contracting Party in accordance with the terms of this Agreement or otherwise, will not infringe upon any third party Intellectual Property Rights.

 

7.3.	Limitation of condition, guarantee or warranty

 

Monash will exercise all reasonable care and diligence and comply with its other obligations under this Agreement in carrying out the Research Services but where permitted by law (including, without limitation, under the Competition and Consumer Act 2010) specifically excludes any condition, guarantee or warranty either express or implied, as to the standard or timeliness of work, the accuracy of, or fitness for a particular purpose of, the Research Services.

 

 

7.4.	Limitation of liability

 

(a)

To the fullest extent permitted by law (including, without limitation, the Competition and Consumer Act 2010), ▇▇▇▇▇▇’s liability under any condition, guarantee or warranty which cannot legally be excluded is limited, at the option of Monash, to supplying the Research Services again or paying the cost of having the Research Services supplied again.

 

(b)

▇▇▇▇▇▇’s liability under this Agreement is reduced to the extent that any damage, liability, loss or cost arises from or is attributable to any act or omission of the Contracting Party, its officers, employees, agents or contractors.

 

7.5.	Contracting Party to bear responsibility and risk

 

The Contracting Party assumes sole responsibility and risk in interpreting, using and exploiting the Developed IP and any Improvements to its Background IP (including any findings, results and recommendations therein) and shall indemnify Monash and its officers, employees and agents against any actions, proceedings, suits, claims and demands arising from such interpretation, use or exploitation by the Contracting Party, its officers, employees, contractors, agents, successors, licensees or assigns; save to the extent such loss, damage or expense is directly attributable to any breach of this Agreement by Monash or any negligent, fraudulent, or unlawful act or omission by Monash, its officers, employees or agents.

 

7.6.	Special, indirect or consequential loss or damage

 

To the fullest extent permitted by law, Monash will not be liable to the Contracting Party or any third party for any special, indirect or consequential loss or damage, or loss of anticipated profits, revenue, data or opportunity, arising from or in any way relating to this Agreement, whether in tort (including negligence), contract, statute, equity or otherwise.

 

7.7	Maximum liability

 

Notwithstanding any other clause in this Agreement and to the fullest extent permitted by law, ▇▇▇▇▇▇’s liability arising from its obligations under this Agreement or in any other manner related to this Agreement, whether in tort (including negligence), contract, statute, equity or otherwise, will not in the aggregate exceed the Fees and Expenses paid under this Agreement.

 

8.

Privacy

 

8.1.

Each Party must handle any Personal Information relating to the Research Services or under this Agreement in accordance with the Privacy and Data Protection Act 2014 (Vic) and the Health Records Act 2001 (Vic), including the Information Privacy Principles and Health Privacy Principles, and any code of practice or guidelines made under these Acts, and must co-operate with all efforts by either Party to comply with these laws, codes and guidelines, including in response to a complaint or a suspected privacy breach.

 

8.2.

Where the Contracting Party discloses any Personal Information it receives from Monash, or it receives, creates or holds in connection with this Agreement, to any third party for the purposes of this Agreement, the Contracting Party must ensure that the third party is subject to enforceable obligations requiring the third party to comply with the obligations in this clause as if the third party were the Contracting Party, and to enforce these obligations against the third party if required to do so by Monash.

 

 

8.3.	To the extent that:

 

(a}

the European Union’s General Data Protection Regulation (2016/679} (GDPR} is applicable to Monash or the Contracting Party (or both} in the context of this Agreement; and

 

(b}

GDPR provisions impose obligations on Monash or the Contracting Party (or both} which are additional to the obligations in clauses 8.1 or 8.2 in respect of personal data as that term is defined in the GDPR,

 

the Contracting Party shall comply with those GDPR provisions in addition to its obligations under clauses 8.1 and 8.2.

 

8.4.

The Contracting Party will indemnify and will continue to indemnify, defend and hold harmless Monash, its officers and employees from and against all claims, losses, liabilities, damages, settlements, expenses and costs (including reasonable legal costs} arising out of or relating to the Contracting Party’s breach of this clause 8 or a breach by any third party of the obligations it undertakes under clause 8.2.

 

9.	Confidentiality and Publication

 

9.1.	Obligations of confidentiality

 

Each party (Receiving Party} receiving, possessing or otherwise acquiring Confidential Information of the other party (Disclosing Party} acknowledges that the Disclosing Party’s Confidential Information is the property of and confidential to or a trade secret of the Disclosing Party. The Receiving Party must:

 

(a}

keep the Disclosing Party’s Confidential Information confidential and not directly or indirectly disclose, divulge or communicate that Confidential Information to, or otherwise place that Confidential Information at the disposal of, any other person without the prior written approval of the Disclosing Party;

 

(b}

take all reasonable steps to secure and keep secure all Disclosing Party’s Confidential Information in its possession or control; and

 

(a)

not deliberately memorise, use, modify, reverse engineer or make copies, notes or records of the Disclosing Party’s Confidential Information for any purpose other than in connection with the performance by the Receiving Party of its obligations under this Agreement.

 

9.2.	Publication rights

 

(a}

With the exception of Specified Confidential Information outlined in 9.2(b}, Monash may publish the Developed IP after providing the Contracting Party with a thirty (30} day period in which to review each proposed publication to identify any inadvertent disclosure of the Contracting Party’s Specified Confidential Information.

 

 

(b}

Specified Confidential Information cannot be published or otherwise communicated without prior written approval from the Contracting Party. When and if the Contracting Party deems further items should be added to this list of items comprising Specified Confidential Information, a Contract Addendum will be provided to Monash by the Contracting Party, outlining the proposed items for agreement. ▇▇▇▇▇▇’s agreement with the addition of these items as Specified Confidential Information will not be unreasonably withheld or delayed. At the date of this Agreement, Specified Confidential Information consists of:

 

(i}

Psi-GAD Trial Treatment Manual

 

(ii}

Psi-GAD Trial Therapist Training Manual

 

(c)

If the Contracting Party notifies Monash in writing within the thirty (30} day period that the proposed publication should not be published due to clause 9.2(a), then the Parties agree that they will communicate with each other in good faith with a view to reaching agreement on whether the proposed publication can be published in some amended form. If the Contracting Party does not respond to Monash within the thirty (30} day period, approval to publish is deemed to be given. Such approvals are not to be unreasonably withheld or delayed.

 

(d}

Excluding the Specified Confidential Information and any information the subject of a Contract Addendum, Monash researchers may discuss the project without written approval from the Contracting Party, for media and other forums such as academic talks, interviews for radio, television, film, other media, or other forums as appropriate to promote the research.

 

9.3.

The Contracting Party shall not publish, or make a public statement about, any findings, results, outcomes or recommendations arising from the Research Services in association with the name, trade marks or logos of Monash or the name of Monash staff, without the express written approval of Monash (which approval is not to be unreasonably withheld or delayed}.

 

9.4.	The Contracting Party shall not represent that Monash or any Monash staff in any way endorse, support or approve of, any products, services, intellectual property or business of the Contracting Party, unless Monash has given its express written consent to such representation.

 

10.	Force Majeure

 

10.1.

Neither party will be liable for any delay or failure to perform its obligations under this Agreement where such delay or failure is due to any event beyond that party’s reasonable control including by reason of any of the following: labor disturbances, shortages or disputes of any kind; natural disasters; national emergencies; government directives or restrictions; civil disorders; acts of war or aggression; acts of God; failure of utilities; mechanical breakdowns; material shortages; epidemics; pandemics (including but not limited to COVID-19}; or similar occurrences (Force Majeure Event}. This clause does not apply to the Contracting Party’s obligation to pay the Fees and Expenses, provided that Monash is ready, willing and able to perform its obligations under this Agreement.

 

10.2.

The Party unable to perform its obligations as a result of a Force Majeure Event must:

 

(a}

notify the other Party promptly of any delay or failure to perform referred to in clause 10.1; and

 

(b}

use reasonable endeavours to resume performance in accordance with this Agreement as soon as practically possible.

 

 

11.	Dispute Resolution

 

11.1.

If any dispute arises between the Parties out of or in connection with this Agreement, the Parties shall endeavour to resolve that dispute by negotiation in good faith.

 

11.2.

If the dispute is not mutually resolved within 20 Business Days of a Party serving on the other Party a written dispute notice, each Party must nominate one senior representative who shall meet as soon as practicable for the purpose of endeavouring to resolve the dispute.

 

11.3.

If within 20 Business Days after submitting the dispute to senior representatives the Parties fail to resolve the dispute then the Parties shall have the right to seek the determination of the dispute in a court or tribunal exercising jurisdiction over such matters in Victoria, Australia.

 

11.4.

The provisions of this clause 11 shall not preclude a Party from seeking urgent interlocutory relief in a court of competent jurisdiction.

 

12.	Termination

 

12.1.

Either Party (Terminating Party) may terminate this Agreement immediately by notice in writing to the other Party (Defaulting Party) if:

 

(a)

the Defaulting Party is in breach of this Agreement and the Defaulting Party fails to remedy the breach, where it is capable of remedy, within 20 Business Days of receiving written notice of the breach from the Terminating Party;

 

(b)

the Defaulting Party is in breach of this Agreement and the breach is not capable of remedy;

 

(c)

an Insolvency Event occurs in relation to the Defaulting Party; or

 

(d)

the Parties agree that the Milestones will not be met, whether because it appears the outcomes will not be attained or for technical reasons the work should not continue.

 

12.2.

Monash may terminate this Agreement immediately by notice in writing if the Contracting Party breaches clause 13.11.

 

12.3.

Upon termination of this Agreement for any reason:

 

(a)

each Party must immediately cease using the other Party’s Confidential Information and promptly return to the other Party its Confidential Information or, if requested by the other Party, destroy it;

 

(b)

in the case of termination pursuant to clause 12.l(d), the Contracting Party will meet payments due to Monash up to the effective date of termination, plus the reasonable costs and committed expenses of Monash which cannot be avoided notwithstanding the termination; and

 

(c)

the termination will be without prejudice to any other remedies available to any Party.

 

 

13.

General

 

13.1.

Nature of obligations

 

(a)

Any provision in this Agreement which binds more than one person binds all of those persons jointly and each of them severally.

 

(b)

Each obligation imposed on a Party by this Agreement in favour of another is a separate obligation.

 

13.2.

Entire understanding

 

This Agreement contains the entire understanding between the Parties concerning the subject matter of this Agreement and supersedes, terminates, and replaces all prior agreements between the Parties.

 

13.3.

Further assurances

 

A Party, at its own expense and within a reasonable time of being requested by the other Party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this Agreement.

 

13.4.

No waiver

 

(a)

A failure, delay, relaxation or indulgence by a Party in exercising any power or right conferred on the Party by this Agreement does not operate as a waiver of the power or right.

 

(b)

A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this Agreement.

 

(c)

A waiver of a breach does not operate as a waiver of any other breach.

 

13.5.

Severability

 

Any provision of this Agreement which is invalid in any jurisdiction must, in relation to that jurisdiction:

 

(a)

be read down to the minimum extent necessary to achieve its validity, if applicable; and

 

(b)

be severed from this Agreement in any other case,

 

without invalidating or affecting the remaining provisions of this Agreement or the validity of that provision in any other jurisdiction.

 

13.6.

No assignment

 

(a)

Subject to clause 13.6, a Party cannot assign or otherwise transfer the benefit of this Agreement without the prior written consent of the other party.

 

(b)

▇▇▇▇▇▇ agrees that the Contracting Party may assign or novate its rights and obligations under this Agreement to a subsidiary of the Contracting Party.

 

 

13.7.

Consents and approvals

 

Where anything depends on the consent or approval of a party then, unless this Agreement provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

13.8.

No variation

 

This Agreement cannot be amended or varied except in writing signed by the Parties.

 

13.9.

Governing law and jurisdiction

 

(a)

This Agreement is governed by and must be construed in accordance with the laws in force in the State of Victoria, Australia.

 

(b)

The Parties submit to the exclusive jurisdiction of the courts of that State and the Commonwealth of Australia in respect of all matters arising out of or relating to this Agreement, its performance or subject matter.

 

13.10.

Notices

 

All notices to be served under this Agreement:

 

(a)

may be served personally, via email, or sent by express post to the address of the recipient as set out in the Details (or to such alternative address which has been notified by the recipient to the sender); and

 

(b)

will be deemed to have been given:

 

(i)

if served personally, on the date upon which it is served;

 

(ii)

if sent by email, upon receipt by the sender of confirmation that the notice has been sent in its entirety to the recipient; and

 

(iii)

if sent by express post, two Business Days after the date of posting.

 

13.11.

Sanctions

 

(a)

Where the Contracting Party is an Australian entity or person:

 

The Parties acknowledges their obligations under Australian sanctions laws, including but not limited to those arising under the Charter of the United Nations Act 1945 (Cth) and the Autonomous Sanctions Act 2011 (Cth), and undertake to comply with those obligations.

 

 

(b)

Where the Contracting Party is not an Australian entity or person:

 

The Contracting Party undertakes not to engage in any act which may result in Monash contravening an Australian Sanctions Law.

 

13.12.

Electronic Signing & Counterparts

 

(a)

Each Party agrees that this Agreement may be executed by electronic signature (regardless of the form of electronic signature utilised) and that this method of signature is conclusive of the parties’ intention to be bound by this Agreement as if physical signing had occurred.

 

(b)

This Agreement may be executed in any number of counterparts and by the parties on separate counterparts. Each counterpart constitutes the agreement of each party who has executed and delivered that counterpart. Each party may communicate its execution of this Agreement by successfully transmitting an executed copy of the Agreement by an electronic method to each party.

 

13.13.

Relationship of parties

 

The Parties are independent contracting parties and nothing in this Agreement may be construed as creating a relationship of partnership, joint venture, employer and employee, principal and agent, or trustee and beneficiary, nor does it grant either Party any authority to assume or to create any obligation on behalf of, or in the name of, the other Party.

 

13.14.

Survival of obligations

 

Clauses 4, 5.2, 6, 7, 8, 9, 11, 12.3 and 13 survive expiry or termination of this Agreement.

 

 

Annexure A - Trial Summary

 

A Phase 2A randomised double-blind active-placebo-controlled trial to assess the safety and efficacy of psilocybin-assisted psychotherapy for Generalized Anxiety Disorder [Psi-GAD-1]

 

Study Type		Double blind active-placebo controlled Phase 2A RCT
Estimated enrolment:		72 participants
Primary Indication:		Generalised Anxiety Disorder (GAD)
Treatment:		Psilocybin-assisted psychotherapy
Treatment sessions:		Two psilocybin or active-placebo dosing sessions; 9 non-drug psychotherapy sessions. [Open-label extension arm for placebo group after 26 week follow-up and unblinding: single psilocybin dosing sessions; 3 additional non-drug psychotherapy sessions].
Primary outcomes:		Safety, efficacy
Secondary outcomes:		Quality of life, functional impairment, comorbidities, mechanisms
Funding (source)		[***]
Timing		[***]

 

 

Investigators

 

Chief Principal Investigator and Trial Co-ordinator: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
Principal Investigators: ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇

 

Brief Description

 

Phase 3 trials pursuing FDA and EMA drug licencing for psilocybin-assisted psychotherapy to treat depression are on course to commence in the US and Europe in 2021. This trial will be a double blind active-placebo controlled RCT assessing safety, efficacy, feasibility and therapeutic mechanisms of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder (GAD). With support from the Usona Institute, and based on the treatment protocols of leading psychedelic research groups, this FDA-compliant pivotal trial is likely to be a world-first using psilocybin to treat GAD. Ancillary options and sub-studies, subject to additional funding or partnerships, include: biomarkers, neuroimaging, Lifestyle Medicine continued care program, performance-based tasks, and app-based ecological momentary assessment. In addition, the trial will fund the development of a specialist training program for trial therapists using psilocybin in the treatment of GAD.

 

Dosing and Psychotherapeutic support

[***] [***]Primary objectives include:

 

[***]

 

Secondary objectives include:

 

[***]

 

 

Indicative Budget Summary: Psi-GAD-1 trial [30-36 months duration]		Total {excl GST)
Study IP and preparation		[***]
Pharmacy		[***]
Project management, patient assessments, research staff		[***]
Administration, set-up, training		[***]
Clinical treatment/ Laboratory assessment		[***]
Miscellaneous (incl participant reimbursement)		[***]
Total		[***]

 

 

Annexure B: Background IP

 

▇▇ ▇▇▇▇▇▇▇▇▇▇ has developed Background IP in a private capacity, and provides the Contracting Party with a non-exclusive, royalty-free licence in perpetuity to use, reproduce, communicate, modify and adapt that Background IP. ▇▇ ▇▇▇▇▇▇▇▇▇▇ retains the rights to use this background IP in future research, development, and other projects. This Background IP consists of a Research Trial Protocol Prototype and a Therapist Training Program Prototype, detailed below.

 

Research Trial Protocol Prototype [psilocybin-assisted psychotherapy clinical trial protocol]: consists of an extensive document (~so pages) that includes the following sections:

 

●	Psychedelic Compounds In Medicine, Psilocybin Summary, Safety Of Psilocybin Use, Risks Of Psilocybin Use.

●	Study Design, Type Of Study, Sample Size, Source Population, Expected Duration Of Participation, Study Measures, lnvestigational Product (Dosage, Storage, Handling And Labelling), Psychotherapy, Concomitant Medications And Psychotropics, Rescue Medications.

●	Participant Recruitment, Consenting Process, Screening For Eligibility, Clinical Laboratory Assessments, Inclusion Criteria, Exclusion Criteria, General Medical Exclusion Criteria, Psychiatric Exclusion Criteria,

●	Study Procedures, Data Points And Associated Procedures, Premature Discontinuation Of The Study, Removal Or Withdrawal Of Participants From The Study.

●

Potential Benefits, Possible Risks And Discomforts Associated With Assessment Measures, Possible Risks And Discomforts Associated With Non-Drug And Experimental Psychotherapy, Possible Risks Of Receiving Psilocybin, Cardiovascular And Sympathomimetic Effects, Possible Psychological Distress Associated With Receiving Psilocybin, Reproductive And Developmental Risks, Drug Dependence And Abuse Potential, Risk Mitigation, Adverse Events, Serious Adverse Events, Medical Emergencies, Serious Adverse Event Collection.

 

Therapist Training Program Prototype [psilocybin-assisted psychotherapy therapist training program]: consists of a document (~25 pages) outlining training schedule, national and international trainers, educational material list, and training content summaries for each session (outline of in- person schedule shown below):

 

●	FOUNDATIONS: Setting the scene on this training; Introductions, broader context of PP; Historic and research overview of PP; Group discussion: questions, concerns; Key trial details; Set-setting protocol.

●

PREPARATION: AIMS: Key Aims Of Preparation; PRACT: Practical Approaches To Preparation; GUEST: Intro, Therapist Qualities, Past Challenges For Psychedelic Research Groups; GUEST: Principles Of PP, Stories From The Field; Clinical Exercise: Somatic And Mindfulness Tools Within Preparation; ROLE PLAY: Preparation; DISCUSSION: Preparation.

●	DOSING: AIMS: Psychedelic experience and supporting therapeutic mechanisms; PRACT 1: Dosing skills; PRACT 2: Risks, safety monitoring, symptoms, adverse events, rescue, reporting, referral; CLINICAL EXERCISE: Dosing skills; ROLE PLAY: dosing; DISCUSSION: dosing.

●	INTEGRATION: AIMS: Key aims of Integration; PRACTICAL: integration; ROLE PLAY: Integration; DISCUSSION: Integration.

●

SYNTHESIS: Trial requirements and key pragmatics for therapists, plus Q&A; GUEST: Safety response, red flags, pre-emptive support, therapist anxiety; PRACTICAL: General considerations, incl screening, rapport, expectation/intention, red flags, dyadic challenges; PRACTICAL: Specific tips, statements, and exercises for each phase; DISCUSSION: take outs, final questions; GUEST: Case studies from TRD trial, tips and hard- earned wisdom, Q&A.