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

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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



 


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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



 


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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.







 


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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. 


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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.


 


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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.



 


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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.
	 	 	 	 	 	 	 	 






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


 





*** 




 


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