Change Order No. 1 to Project Agreement between Novotech (Australia) Pty Limited and Lexaria (AU) Pty Ltd

Summary

This agreement is a change order to a previous project agreement between Novotech (Australia) Pty Limited and Lexaria (AU) Pty Ltd. It updates the budget and key assumptions for clinical trial support services provided by Novotech, reflecting changes in study parameters and responsibilities. The revised terms, effective May 14, 2025, include an updated scope of services, increased subject numbers, and a new budget. All other terms of the original agreement remain unchanged.

EX-10.2 2 lxrp_ex102.htm CHANGE ORDER TO PROJECT AGREEMENT lxrp_ex102.htm

EXHIBIT 10.2

Change Order No. 1

Date: as per the last signature date of the Parties

Parties

1.	Novotech (Australia) Pty Limited ACN 071 874 881 of Level 19, 66 Goulburn Street, Sydney NSW 2000, Australia (Novotech)

2.	Lexaria (AU) Pty Ltd of C/- Suite 1, Level 3, 62 Lygon Street, Carlton, Victoria, 3053, Australia (Sponsor)

Background

A	On December 2, 2024, Novotech and Sponsor entered into a Project Agreement (Project Agreement) pursuant to which Novotech is providing services to support clinical trials to Sponsor.

B	The parties agree that this Change Order sets out the amendments to the Project Agreement which are agreed between the Sponsor and Novotech.

C	Capitalised terms in this Change Order have the same meaning as in the Project Agreement.

D	The parties agree to change the terms of the Project Agreement from May 14, 2025 (Effective Date), as follows:

1	Change Order Details

1.1	This Change Order sets out the changes to the Budget for the Services in the Project Agreement as agreed by the parties. The changes are as a result of changes to the Key Assumptions (Study Assumptions and Responsibilities) as set out in Schedules 1 and 2 hereof.

1.2	The revised Key Assumptions for the Study (Revised Key Assumptions) are set out in Schedules 1 and 2. The parties agree that the Revised Key Assumptions accurately reflect the Study parameters and the Services to be performed by Novotech from the Effective Date.

1.3	The parties agree that all other terms of the Project Agreement remain the same.

Change Order #01	Version 6, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 1 of 14

Executed as an Agreement

Signed for and on behalf of Novotech (Australia) Pty Limited by its authorised representative:

Signed for and on behalf of Lexaria (AU) Pty Ltd by its authorised representative:

Signature of Chief Commercial Officer

“Barry Murphy”

Signature of Director

“John Docherty”

Signature of Director

“Janice Henrichs”

Change Order #01	Version 6, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 2 of 14

Schedule 1 Scope of Services -

Region- Site- Subject Strategy

REGION	#Previous Subjects	# Revised Subjects
Australia	80	120
TOTAL	80	120

Monitoring Visits

REGION	Previous IMVs	Revised IMVs	Previous Remote IMVs	Revised Remote IMVs
Australia	21	63	35	21
TOTAL	21	63	35	21

Change Order #01	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 3 of 14

Schedule 2 Services Budget

Revised Budget

Direct Fees (AUD)	Revised Total Budget	PA Budget	Change Order Budget
Medical Writing Start-up	[**]	[**]	[**]
Drug Development Consulting	[**]	[**]	[**]
Regulatory and Ethics	[**]	[**]	[**]
Start-up Activities	[**]	[**]	[**]
Clinical Site Management	[**]	[**]	[**]
Study Management	[**]	[**]	[**]
Data management	[**]	[**]	[**]
Biostatistics	[**]	[**]	[**]
Pharmacovigilance	[**]	[**]	[**]
Medical Monitoring	[**]	[**]	[**]
Clinical Study Report	[**]	[**]	[**]
Total Professional Fees	[**]	[**]	[**]
Discount (20%)	[**]	[**]	[**]
Total Professional Fees (with discount)	2,648,963.39	2,349,040.44	299,922.96
Biometrics and/or Pharmacovigilance will be delivered by our Australian team, and applicable for R&D tax rebate.
Hosting Fees (AUD)
Clinical Systems Hosting Fees	[**]	[**]	[**]
EDC Cost	[**]	[**]	[**]
Total Hosting Fees	[**]	[**]	[**]
*Total Service Fees ()**	3,064,066.45	2,764,143.49	299,922.96
* Total Service Fees do not include inflation. Inflation will be applied annually based on CPI.
Pass-through Costs (AUD)
Pass-through Costs	[**]	[**]	[**]
Investigator Fees	[**]	[**]	[**]¹
Total Pass-through Costs	3,918,183.00	2,318,390.00	1,599,793.00
Grand Total	6,982,249.45	5,082,533.49	1,899,715.96

¹The line item costs with associated specific activities have been redacted to allow the CRO and any third party service provider to maintain competitive negotiations with other sponsors.

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_Diabetes_2024-5470	Page 4 of 14

Detailed Budget for Services

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

Medical Writing Start-up

Protocol Synopsis - Review and Update

Per Protocol Synopsis

[**]

Protocol writing, QC and finalisation (excluding protocol synopsis)

Per Protocol

[**]

Protocol amendment writing, QC and finalisation- minor amendment (Amendment 1)

Per Minor Amendment

[**]

Protocol amendment writing, QC and finalisation- major amendment (Amendment 3)

Per Major Amendment

[**]

Subtotal

[**]

Drug Development Consulting

Investigator Brochure writing, QC and finalisation (Semaglutide)

Per IB

[**]

CBD IB update

Per IB

[**]

Tirzepatide IB

Per IB

[**]

Subtotal

[**]

Regulatory and Ethics

IRB/EC Submission

Per Total Site

[**]

IRB/EC Submission (Post Initial Submission upto Protocol amendment -v4/v5)

Per Total Site (Major submission)

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 5 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

IRB/EC Submission (Post Initial Submission minor submission PCLs PICF Memos upto PICF v6)

Per Total Site (Minor submission)

[**]

Regulatory Submissions

Per country (Reg Submission)

[**]

Regulatory Submissions (Post Initial - 1. Arm 5 and for future Site location/PI changes

Per site HA Submission (Updates Post Initial submission)

[**]

Regulatory Study Management and Oversight (Start-up)

Per Month (Start-Up)

[**]

Regulatory Study Management and Oversight (Recruitment, Treatment & Follow-up)

Per Month (Ex Startup & Closeout)

[**]

Informed Consent Preparation, Review and Finalisation

Per Site

[**]

PICF updates (Post start-up) CO#01

PICF update per site

[**]

Act as Local Sponsor

Per Study

[**]

Subtotal

[**]

Start-up Activities

Kick-off meeting

Per Study

[**]

Team Training

Per Study

[**]

CRA Training Meeting

Per Study

[**]

Site Feasibility

Per Study

[**]

Clinical System Set Up

Per Study

[**]

Project and Operational Plans

Per Study

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 6 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

Site Qualification Visits (On-site)

Per QV

[**]

Phone SQVs

Per Phone QV

[**]

Investigator Meeting

Per IM

[**]

Site Contract and Budget Management

Per Site

[**]

Site Contract and Budget Management Post Start-up (CO#01)

Per Site per update

[**]

Site Management- Start up

Per Site Per Month (Start Up)

[**]

Vendor Identification and Contracting

Per Vendor

[**]

Subtotal

[**]

Clinical Site Management

Site Initiation Visits

Per SIV

[**]

Interim Monitoring Visits (Recruitment and Treatment)

Per revised IMV (Rec-Treat)

[**]

Co-monitoring visits

Per Co-visits (Rec-Treat)

[**]

Offsite -ediary data listing review – fortnight

Per data listing review

[**]

Remote Monitoring Visits

Per revised Remote IMV

[**]

Site Management (Recruitment, Treatment)

Per Site Per Month (Recruitment & Treatment) - SM

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 7 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

Site Management - Close-Out

Per Site Per Month (Close-Out)

[**]

Close-out Visits

Per COV

[**]

Subtotal

[**]

Study Management

Project Management - Pre-Start-up

Per Month (Pre-Start-Up)

[**]

Project Management- Start Up

Per Month (Start-Up)

[**]

Project Management- Recruitment and Treatment

Per Month (Recruitment & Treatment)

[**]

Project Management- Close-out

Per Month (Close-Out)

[**]

Vendor management/communication

Per Month

[**]

Subtotal

[**]

[**]

Data management

Database Design and Set-up

Per Set-Up Stage

[**]

Design and Program Edit Check Specifications

Per Study

[**]

External Data Set Up and Programming

Per Study

[**]

Develop Data Management Plans

Per Study

[**]

RTSM- Set Up

Per Study

[**]

E-Diary additional updates and programming activities for adding treatment arm 5

Per Study

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 8 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

RTSM additional updates and programming for adding treatment arm 5

Per Study

[**]

EDC programming and updates and programming for adding treatment arm 5

Per Study

[**]

Tirzepatide sentinel and replacements arms 1-4 manual programming

Per Study

[**]

eDiary programming widening of open hrs window

Per Study

[**]

Data Management- Recruitment- FU

Per Month (Recruitment, Treatment, Follow-Up)

[**]

Medical Coding

Per Month (Recruitment, Treatment, Follow-Up)

[**]

External Data Handling and Transfer

Per Month (Recruitment, Treatment, Follow-Up)

[**]

RTSM- Recruitment- Treatment

Per Month

[**]

RTSM- Close-out

Per Study

[**]

Database Lock

Per Study

[**]

Data Management- Close out

Per Month (Close-Out)

[**]

Subtotal

[**]

Biostatistics

Production of SAP & TFL Shells

Per Study

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 9 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

Programming of TLFs- Final Analysis

Per Study

[**]

Final Statistical Analysis

Per Study

[**]

CDISC Conversion (Final)

Per Study

[**]

Biostatistics Management: Start-up

Per Month (Start-Up)

[**]

Biostatistics Management: Maintenance

Per Month (Recruitment, Treatment, Follow-Up)

[**]

Biostatistics Management: Close-out

Per Month (Close-Out)

[**]

Programming of TLFs for DSUR

Per Study

[**]

Subtotal

[**]

Pharmacovigilance

Safety Database Set-up

Per Study

[**]

Safety Management Plan

Per Study

[**]

Safety Management and Periodic Reporting

Per Month (Ex. Start-Up)

[**]

SAE Management

Per SAE Report

[**]

SUSAR Management and Investigator Reporting

Per SUSAR Report

[**]

DSUR Generation and QC

Per Year

[**]

Subtotal

[**]

Medical Monitoring

Monthly Oversight - Start up

Per Month (Start-Up)

[**]

Monthly Oversight - Recruitment

Per Month (Recruitment)

[**]

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 10 of 14

Budget

TOTAL/REVISED Budget

PA Budget

Change Order Budget

Task Description

Pricing Unit

Unit Price (AUD)

Disc Unit Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# Units

Total Price (AUD)

Disc Total Price (AUD)

# CO Units

Total Price (AUD)

Disc Total Price (AUD)

Monthly Oversight - Treatment

Per Month (Treatment)

[**]

Monthly Oversight - Close-out

Per Month (Close-Out)

[**]

Subtotal

[**]

Clinical Study Report

Final Clinical Study Report (CSR) writing, QC and finalisation

Per CSR

[**]

Subtotal

[**]

Medical Writing Start-up

[**]

Drug Development Consulting

[**]

Regulatory and Ethics

[**]

Start-up Activities

[**]

Clinical Site Management

[**]

Study Management

[**]

Data management

[**]

Biostatistics

[**]

Pharmacovigilance

[**]

Medical Monitoring

[**]

Clinical Study Report

[**]

Total

[**]

2,349,040.44

[**]

299,922.96

Discount %

[**]%

Discount $

[**]

Grand Total

[**]

2,349,040.44

299,922.96

* Total Service Fees do not include inflation. Inflation will be applied annually based on CPI.

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 11 of 14

Hosting and Lab Estimate
Task Description	Pricing Unit	Unit Price (AUD)	# Units	Total Price (AUD)	# Units	Total Price (AUD)	# CO Units	Total Price (AUD)
Hosting Fees		-	-	-	-	-	-	-
Clinical Systems Hosting Fees	Per Month	[**]	[**]	[**]	[**]	[**]	-	-
Subtotal		-	-	[]**	-	[]**	-	-

Pass-through Cost Estimate			Revised budget		PA budget		CO#01 budget
Task Description	Pricing Unit	Unit Price (AUD)	# Units	Total Price (AUD)	# Units	Total Price (AUD)	# CO Units	Total Price (AUD)
Regulatory And IRB/IEC Submission Fees				-
HA/Competent Authority Submission (Initial)	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
IRB/IEC Submission Fee (Initial)- Central	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Post initial HREC submissions (All major submissions to BB HREC upto PA 4/v5 and 4 subsequent)	Per Reg Submission	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Post initial HA submissions	Per Reg Submission	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Subtotal		-	-	[]**	-	[]**	-	[]**
Vendor Costs		-	-	-	-	-	-	-
Drug Storage & Distribution	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Central Lab	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Courier	Per Month	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Marken Fee	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Phone /Administration/ Stationery	Per Month	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Subtotal		[**]	[**]	[**]	[**]	[**]	[**]	[**]
Monitoring Costs		-	-	-	-	-	-	-
Travel – Transport & Accommodation	Per Visit	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Parking for Local Sites	Per Visit	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Subtotal		[**]	[**]	[**]	[**]	[**]	[**]	[**]
Total Pass Through Fees				1,384,388.00		845,955.00		538,433.00
All pass through costs are provided as estimates only with the exception of local phone and internal stationery/photocopy fees which will be invoiced at a fixed cost of AUD75 per site per month.
Details of pass through costs will be provided in Excel and be invoiced on a monthly basis using the exchange rate on the day of invoicing.

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 12 of 14

Pass-through Cost Estimate			Revised budget		PA budget		CO#01 budget
Task Description	Pricing Unit	Unit Price (AUD)	# Units	Total Price (AUD)	# Units	Total Price (AUD)	# CO Units	Total Price (AUD)
Investigator Fees Estimate		-	-	-	-	-	-	-
Investigator Fee - Per Screen Fail Patient	Per Screen Fail Patient	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Investigator Fee - Per Patient	Per Patient	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Site Fees- Set Up	Per Site	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Site Fees- Annual Administration	Per Site Per Year	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Close-out and Archiving Fee	Per Site	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Subtotal		[**]	[**]	[**]	[**]	[**]	[**]	[**]
Total Investigator Fees		[**]	[**]	[**]	[**]	[**]	[**]	[**]
EDC Hosting Estimate
EDC Professional Services Fee -Study Conduct	Per Month (EDC)	[**]	[**]	[**]	[**]	[**]	[**]	[**]
EDC Hosting/Licensing Fees - Medidata	Per Month (EDC)	[**]	[**]	[**]	[**]	[**]	[**]	[**]
EDC Professional Services Fee (URL and Coder fee) - Medidata	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Device Service & Subscription fee	Per Study	[**]	[**]	[**]	[**]	[**]	[**]	[**]
Subtotal		[**]	[**]	[**]	[**]	[**]	[**]	[**]
Total EDC Fees	[**]	[**]	[**]	[**]	[**]	[**]	[**]²	-

2 The specified activities and associated costs have been redacted to allow the CRO and any third party service provider to maintain competitive negotiations with other sponsors.

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 13 of 14

Schedule 3 Payment Schedule -

The following changes are made to the Security Deposit under the Project Agreement:

Security Payment- Direct Fees ([]%)**	Total (AUD)
Upon Execution of the Agreement	[**]
Total	[]**

Security Payment- Pass-Through Costs ([]%)**	Total (AUD)
Upon Execution of the Agreement	[**]
Total	[]³**

3 The percentage of the Total Direct Fees and Pass Through Costs, along with the total fee value being provided as a security deposit has been redacted to allow the CRO to maintain competitive negotiations with other sponsors.

Change

Change order # 01 Schedule –	Version 1, November 2021
Lexaria Bioscience_GLP-1-H24-4_2024-5470	Page 14 of 14