Document:

Exhibit
4.25

 

CERTAIN INFORMATION (INDICATED BY [***])
HAS BEEN EXCLUDED FROM THE VERSION OF THIS DOCUMENT FILED AS AN EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND THE TYPE OF INFORMATION
THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.

 

STRATEGIC
CHEMICAL DEVELOPMENT CAPABILITIES ACROSS THE CURIA NETWORK 

 

 

 

Program
for cGMP Manufacture of Oxypurinol API

 

PREPARED
FOR

 

XORTX
Therapeutics Inc Inc.

 

	REF
    NUMBER	0-90687
    Version 07	 	DATE
    OF ISSUE	29Mar2022

 

		TO:	Grace
                                         Jung, PhD

                                         Chemistry and Manufacturing

                                         XORTX Therapeutics Inc.

                                         4000 421 7th Avenue SW

                                         Calgary, Alberta T2P 4K9

                                         CANADA

 

		FROM:	Richard
                                         Decina

                                         Senior Director, CMO-CS Sales & Business Development

                                         Curia

                                         richard.decina@curiaglobal.com

 

THIS
PROPOSAL IS VALID until March 21 

 

	Proposal
    Reference: O-90687

    Version: 07	 
	curiaglobal.com	Page
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Curia
and XORTX hereby agree that this proposal amends, supersedes and replaces proposal O-90687 dated March 17, 2022 between the parties
(the “legacy proposal”) and upon execution of this proposal by both parties, the legacy proposal shall be of no further
force and effect.

 

Program
Overview

 

Pursuant
to your recent request, Curia Spain, S.A.U. (“Curia”) is pleased to provide XORTX Therapeutics Inc. (“XORTX”)
with this proposal for process familiarization/feasibility study and analytical method transfer of the API as well as preliminary
costing for the activities required to conduct the cGMP manufacture of API as a registration and validation campaigns for XORTX’s
budgetary purposes.

 

Curia
will manage this program in conjunction with XORTX, to an agreed project plan and budget. Table 1 outlines the initial process
familiarization work to start the program. Table 2 outlines the additional activities based on the outcome of the process transfer/familiarization
work. Table 3 outlines the invoicing schedule.

 

Table
1. Process Familiarization Activities

 

	Part	Description
    of Services	Price
    ($)	Anticipated
    *Timeframe
	I.	Process
    Familiarization/Transfer	$65,000	2.5
    Months
	II.	Analytical
    Method Transfer including Reference Standard Qualification	$156,000	3
    Months
	III.	Raw
    Material vendor qualification	$12,000	4month
	 	TOTAL	$233,000	 
	 	 	 	 

 

		●	Parts
                                         I, II, and PartI-III tasks will be carried out in parallel to compress timeline to facilitate
                                         engineering and registration batches execution in a timely manner.

 

Curia
has provided XORTX with costing for the activities required to conduct the Registration, Validation, and Commercial campaigns
of the API.

 

*Pricing
will be updated if the costs vary by more than 5% following process familiarization and analytical methods transfers. Prices for
validation and commercial quantities are the best estimates at this time and will be finalized after registration batches

 

^
Curia will use its best effort to manufacture the Engineering Batch as a GMP batch.

 

Table
2. Activities to Support Registration, Validation and Commercial Campaigns

 

	Part	Description
    of Services	Price
    ($)	Anticipated
    Timeframe
	IV.	PGI
    assessment & Risk Assessment

    Nitrosamines	$13,000	2
    Months
	V	Non
    —GMP batch (minimum 10Kg)	61,700	3
    weeks

 

	Proposal
    Reference: O-90687

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	Part	Description
    of Services	Price
    ($)	Anticipated
    Timeframe
	VI.	^Production
    Engineering Batch (20 Kg)	$69,700	3
    weeks
	VII.	Production
    Clinical batch (40 kg)	$139,400	3
    weeks
	VIII.	Production
    Registration Batches (3 x 40 Kg)	$418,400	4
    Months
	IX.	Critical
    Process Parameters Study (CPP)	$156,000	6
    Months
	X.	*Validation
    Batches (3x 50 Kg)	$337,300	4
    Months
	XI.	*Commercial
    Manufacturing

    (Assuming 300 kg manufacture with 50 Kg batch size)	2250/Kg

    (Total: $675,000)	TBD
	XII.	Stability
    Program	 	36
    Months
	●        
    Engineering Batch	$24,700
	●        
    Clinical Batch	$24,700
	●        
    Registration Batches	$73,900
	●        
    Validation Batches	$73,900
	XIII.	Regulatory
Support 

        (Documentation
        to support registration Batches)

         
	$29,800	3
    Months
	 	TOTAL:	$2,097,500	 

 

The
actual timeframe for completion of each Part of this proposal is dependent upon resource and equipment availability and the timely
receipt of materials. Upon signature of this proposal, Curia shall provide a Gantt chart detailing the activities as appropriate.
Company policy dictates that we can commit resources and equipment only after receipt of written approval. Curia will use it’s
best effort to follow the outline below:

 

	Date	Services
	February
    22	Selection
    of vendor
	March
    22	Due
    diligence and receipt of PO, order raw mats for lab and campaign
	April
    22-June 22	Familiarization,
    AMTE, process fit, HAZOP, qualification sample prep
	July
    22	MBR
    review and agreement, testing and release of raw material for campaign
	July
    22	Minimum
    10 Kg non-GMP batch
	August
    22	Summer
    shutdown
	September
    22	Engineering
    batch 20 kg and testing
	September
    22	Clinical
    batch 40 kg
	October
    22-November 22	3x40
    kg registration batches
	December
    22	Registration
    batches release and Registration campaign report
	Q1
    2023	Process
    validation preparation
	Q2
    2023	Process
    validation

 

	Proposal
    Reference: O-90687

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Table
3. Invoice Schedule

 

	Description
    of Services	Payment
	 	 
	Process
    Familiarization/Transfer	●     To be billed monthly
	Analytical
    Method Transfer including Reference standard qualification	●     Due
    upon issuance of AMTE sign-off
	Raw
    Material vendor qualification	●     Due upon completion and issue of report
	PGI
    assessment & Risk Assessment Nitrosamines	●     Due upon completion and issue of report
	Non-GMP
    batch (10 Kg)	●     Due in 30 days upon issuance of COA
	Production
    Engineering Batch (20 Kg)	●     Due in 30 days upon issuance of COA or release
	Production
    Clinical batch (40 Kg)	●     Due in 30 days upon issuance of COA or release
	Production
    Registration Batches (3 x 40 Kg)	●     Due in 30 days upon issuance of COA or release
	Validation
    Batches (3x 50 Kg)	●     Due in 30 day upon issuance of COA or release

 

In
order to best accommodate XORTX’s project timeline, Curia will utilize its global network to complete each piece of work,
where applicable. Curia shall invoice the work as it is being completed from the site where the work is performed.

 

The
                                         fastest path to approval and commercialization is using our in-house regulatory team.
                                         Our team has decades of combined experience and real time knowledge of current global
                                         regulatory trends. Working closely with our technical team to define what parameters
                                         are Established Conditions (EC’s); we can devise appropriate regulatory strategies,
                                         clear hurdles, and produce submission ready documentation.

 

Let
us know if you would like to speak with our regulatory experts about how we can fast track your commercial strategy.

 

	Proposal
    Reference: O-90687

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Project
Details

 

This
section specifies the services and deliverables to be provided by Curia as outlined in Table 1.

 

“cGMP”
or “GMP” as specified in the International Conference on Harmonization (“ICH”) guide Q7 “ICH Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (“API”), as applied to the manufacture,
testing, and quality control of APIs.

 

I.       Process
Familiarization/transfer

 

Prior
to initiating the scale-up activities, Curia shall evaluate and familiarize with the current process provided by XORTX to ensure
reproducibility, quality, and safety on scale.

 

We
recommend utilizing our Full-Time Equivalent (“FTE”) program since this approach allows XORTX the flexibility of changing
scope and direction during the course of the work. Curia estimates that this process transfer/familiarization effort will require
an overall effort of 2.5 FTE months. Under the FTE program, the scientists are dedicated to your project and will provide XORTX
with regular updates on its progress. The FTE rate for this project is $26,000 per month per scientist to be billed on a monthly
basis.

 

The
total labor fee, reimbursable expenses for all chemicals and materials, and anticipated timeframe for this work are outlined in
the table below.

 

	Description
    of Services	Estimated
    Fee ($)	Anticipated
    

    Timeframe
	Process
    Familiarization/transfer	$65,000	2.5
    Months

 

Please
appreciate that depending on the ongoing observations made and results obtained for this work, it is possible that this work may
be completed in more time than is estimated herein. Should this be the case, Curia will not proceed with, nor bill XORTX for any
further work unless XORTX provides written approval to do so.

 

II.       Analytical
Method Transfer and Raw Material vendor Qualification

 

Curia
shall transfer and qualify the analytical methods which are required to support this program. This work shall include the following
activities.

 

Verification
of analytical methods for:

 

		●	Raw
                                         material carbonitrile

		●	Intermediate
                                         carboxamide hemisulfate

		●	Oxypurinol
                                         API

		●	Reanalysis
                                         of the impurities and WS after reception

 

The
fixed fee and anticipated timeframe for this work are outlined in the table below. 

	Proposal
    Reference: O-90687

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	Description
    of Services	Fixed
    Fee ($)	Anticipated
    

    Timeframe
	Analytical
    Method Transfer including Reference standard qualification  	$156,000	3
    Months
	Raw
    Material vendor qualification	$12,000	1month

 

Assumptions

 

		●	Should
                                         any additional analytical work other than what is estimated herein be required, XORTX
                                         would be contacted and updated on this information. At that point, XORTX, at its sole
                                         discretion, will have the option to extend this portion of the program.

		●	Analytical
                                         methods for the raw material carbonitrile 2, intermediate carboxamide hemisulfate (3),
                                         and Oxypurinol API are available. The methods for the API have been validated.

 

Deliverables

 

		●	Written
                                         Test methods which includes a summary of the results.

		●	Raw
                                         materials and vendors qualification summary report

 

Terms
and Conditions

 

All
work specified herein is governed by Curia’s Manufacturing and Supply of Active Pharmaceutical Ingredients, Intermediates
and/or Fine Chemicals (“API”) Terms and Conditions which can be found at https://www.curiaglobal.com/terms-and-conditions/Terms
- Ex works, Curia Spain

Payment
— net
3o days

Cancellation
- In
the unlikely event Xortx needs to terminate the project during its implementation for any valid reason (e.g. unfavorable clinical
results) or the product development should cease, the following cancellation costs will apply:

 

		●	Curia
                                         will charge for the work completed, work in-progress, unreturnable raw materials, unused
                                         site capacity which could not be filled, raw materials contract obligations, any cancellation
                                         on equipment installation for production ramp up, and disposal costs pertaining to raw
                                         materials or intermediates.

		●	Raw
                                         material credits: To the extent Curia can cancel/return orders for raw materials or to
                                         the extent Curia can allocate RMs to other customers/projects, Curia will credit such
                                         amounts to the cancellation fees owed by Xortx above.

 

Any
terms and conditions contained in a purchase order or other document which are additional to or inconsistent with the above Terms
and Conditions shall be void, unless specifically agreed to by Curia in writing, signed by Curia’s duly authorized representative.

 

	Proposal
    Reference: O-90687

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Fee
for Additional Services

 

Should
XORTX request Curia to perform any of the following services in connection with this project then the following fees will apply:

 

	FEE
    FOR SERVICE
	DESCRIPTION	PRICE
    ($)
	Handling
    costs per shipment (processing paperwork related to shipping) of project related materials	$250
per shipment Does not include XORTX Specific Packaging 

	Shipping
    of Any Materials (FIO Samples, intermediates, API, etc.) is the Responsibility of XORTX	In
    addition to the above handling fees; shipping costs will be dependent on size, conditions, and destination
	Issue
    of Certificate of Destruction or Disposal of Material (per request - includes accountability, the preparation of materials
    for destruction, and the charges related directly to the actual transportation and destruction of materials	$500
    for up to 50 g 

    $1,000 for 51 g - 1 kg 

    $1,300 for >1 kg
	Storage
    of XORTX Materials, Intermediates and APIs	From
    $1,500 per project per month and a Storage Agreement will be provided
	Storage
    of Stability/Retention Samples After Completion of Protocol/Project	From
    $1,500 per project per month
	XORTX
    Specific Packaging	TBD
	cGMP
    Repackaging	From
    $2,500 per batch
	High
    Potency or Controlled Substance cGMP Repackaging	From
    $3,500 per batch

 

Project
Pricing Notes

 

		●	If
                                         additional services are required that exceed the standard Curia practices (i.e. per a
                                         client specific Quality Agreement) additional costs may be incurred. This also includes
                                         changes to the scope of work due to new objectives or incomplete information.

		●	In
                                         the event that the compound is determined to require the use of Curia’s high-potency
                                         laboratories, special handling requirements (controlled substance or under nitrogen)
                                         or other containment, a revision to this proposal will be necessary.

		●	The
                                         pricing in this proposal applies only to the specific services and deliverables listed
                                         herein. Any increase or change to the scope of services and/or deliverables including,
                                         but not limited to, analytical testing beyond regulatory requirements, supply of reference
                                         standards, technology transfer to third parties, regulatory consulting and support, out-of-specifications
                                         investigations and process safety evaluations will require a price change and a revised
                                         or additional proposal.

 

	Proposal
    Reference: O-90687

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		●	Any
                                         meetings, shipping or travel charges incurred outside of Curia facilities in connection
                                         with the performance of this project will be agreed in advance with XORTX and separately
                                         invoiced.

 

Contractual
Agreement & Sign-Off

 

Your
acceptance and execution of this proposal is expressly limited to you either countersigning this proposal or issuing a purchase
order against it; provided that issuing a purchase order is only permitted for administrative purposes and its underlying terms
shall not apply to this project.

 

Once
signed, a copy of the entire document may be emailed to BusDevHelp@curiaglobal.com and
the appropriate Business Development Representative.

 

Hard
copies, if needed, should be mailed to:

Curia
Spain, S.A.U

Attention:
Customer Service

Parque
Tecnológico de Boecillo, Parcela 105

47151
Boecillo, Valladolid, Spain

Tel:
+34 983 54 8o 72, Fax: + 34 983 54 81 13

Email:
raquel.poveda@curiaglobal.com

 

Please
feel free to contact me if there is any further information that Curia can provide about any aspect of this proposal. I look forward
to hearing from you.

 

Sincerely,

 

/s/
Richard Decina

 

	 	Agreed
    and Understood:
	Richard
    Decina	 
	Senior
    Director, Business Development	/s/
    Allen Davidoff
	 	Signature
	 	Allen
    Davidoff
	 	Name
    (Print)
	 	 
	 	March
    31, 2022
	 	Date

 

XORTX
Financial Details

	If
    a Purchase Order is required for administrative purposes:	 	Yes	 	No
	If
    Yes is selected, please record the P.O. number here:	 
	 	Initial:	 	Date:	 
	If
    XORTX requires a purchase order for administrative purposes; we request that XORTX provide the applicable purchase order #
    within five to ten days of XORTX’s signature of this proposal. The purchase order must reference the Curia proposal
    reference number in order for Curia to schedule project and the purchase order underlying terms shall not apply to this project.
	 	 	 	 	 	 	 	 

	Proposal
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Payments
are requested to be remitted by wire/ACH. Curia’s electronic funds transfer information is as follows:

 

*** 

 

	Proposal
    Reference: O-90687

    Version: 07	 
	curiaglobal.com	Page
    9 of 9Exhibit 4.26 

 

CONSULTING
AMENDING AGREEMENT

 

THIS
AGREEMENT made as of Jan 27, 2022

 

BETWEEN:

 

Stephen
Haworth, of the State of Pennsylvania (hereinafter referred to as the "Consultant")

 

OF
THE FIRST PART,

 

-
and -

 

XORTX
Therapeutics Inc., a corporation incorporated under the

laws of British Columbia, Canada (hereinafter referred to as the

"Corporation")

 

OF
THE SECOND PART.

 

THIS
AGREEMENT WITNESSES that in consideration of the covenants and agreements contained herein, the parties hereto agree as follows:

 

WHEREAS
the Corporation and the Consultant (collectively, the "Parties") entered into an Independent Contractor Agreement
dated July 1, 2021 (the "Original Agreement");

 

AND
WHEREAS the Parties wish to amend the Original Agreement and to continue the engagement of the Contractor with the Company
on the terms and conditions set out in the Original Agreement, as amended by this Consulting Amending Agreement;

 

NOW
THEREFORE in consideration of the premises and the mutual covenants herein contained, and other good and valuable consideration,
the Parties hereby covenant and agree as follows:

 

		1.	Term
of Agreement

 

Section
1.02 is replaced entirely with the following language:

 

The
provision of services by the Consultant to the Corporation hereunder shall commence on November 1, 2021 and shall continue for
a period of 12 months and supersedes any prior agreements and will terminate on October 31, 2022, subject to earlier termination
of this Agreement as set forth in Article Five herein.

 

		2.	Change
in Fee

 

Section
2.01 is replaced entirely with the following language:

 

The
Corporation shall pay to the Consultant for the services provided under this Agreement a rate of:

 

-
 $18,750 USD per month to devote 100% of their efforts on behalf of XORTX Therapeutics Inc.

 

     

     

    

 

-
and will be eligible for an additional payment of up to 30% of the total of the contract at the time of the grant of the payment,
subject to the discretion of the compensation committee.

 

		3.	Law
and Jurisdiction

 

All
references to "Ontario" in Sections 6.09 and 6.10 are hereby changed to "Alberta".

 

		4.	Section
2.04 and 5.03

 

Section
2.04 and Section 5.03 are removed entirely.

 

		5.	Other
Terms

 

All
other terms of the Original Agreement remain unchanged.

 

		6.	Legal
Advice and Entire Agreement

 

This
Amending Agreement, together with the Original Agreement, constitutes the entire agreement between the Parties and supersedes
and replaces any prior agreements between the Parties, whether oral or in writing. The Contractor and Principal acknowledge that
they have had the time and opportunity to obtain independent legal advice with respect to the execution of this Amending Agreement
or have waived that opportunity, and that the Contractor and Principal have read, understand, and agree with all of the terms
and conditions contained herein.

 

IN
WITNESS WHEREOF the Parties have executed and delivered this Amending Agreement as of the day and year first written above.

 

	XORTX Therapeutics Inc.	 	On behalf of Stephen Haworth
    and in his personal capacity as Principal
	 	 	 
	per:	 	 
	 	 	 
	/s/ Allen
    Davidoff	 	/s/ Stephen Haworth
	Allen Davidoff, President and CEO	 	Stephen Haworth

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