Exhibit
4.22






 


 


GLOBAL MASTER SERVICES AGREEMENT


 


THIS
GLOBAL MASTER SERVICES AGREEMENT is made on the date of the last signature (the “Effective Date”) by and
between ALTASCIENCES COMPANY INC. (“CRO”) having its principal place of business at 575, boul. Armand-Frappier,
Laval, Quebec, Canada, H7V 4B3, and its Affiliates, and XORTX Therapeutics Inc. (“Sponsor”), having its principal
place of business at c/o Suite 4000, 421 – 7th Avenue, Calgary, T29 4K9 (each a “Party,” and collectively, the
“Parties”).


 


WHEREAS
Sponsor desires to retain CRO to provide the Services, upon the terms and conditions hereinafter set forth, and CRO is willing
to perform such Services;


 


WHEREAS
the Parties have agreed to enter into this Agreement setting out the general terms and conditions for the performance by CRO
of the Services to Sponsor;


 


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


 


		1.	DEFINITIONS



 


		1.1	“Affiliate(s)”
                                         of a Party shall mean any entity which directly or indirectly controls, is controlled
                                         by, or is under common control with that Party at any time during the period for which
                                         the determination of affiliation is being made.



 


		1.2	“Agreement”
                                         shall mean this Global Master Services Agreement, including all exhibits and all Statements
                                         of Work entered into in accordance with the terms hereof, as it may be amended from time
                                         to time in accordance with its terms.



 


		1.3	“Closing
                                         Date” shall mean, in relation to a Drug or a Test Article, the date of the
                                         first dose administration of such Drug or Test Article.



 


		1.4	“Drugs”
                                         shall mean the Study medications supplied by Sponsor and may include in certain situations,
                                         the devices supplied by Sponsor in connection with a clinical portion of a Study.



 


		1.5	“Protocol”
                                         shall mean the approved protocol in connection with a Study and all amendments thereto.



 


		1.6	“Representatives”
                                         shall mean any Affiliates, employees, officers, directors, shareholders, agents, subcontractors
                                         or advisors, including attorneys and accountants of a Party.



 


		1.7	“Samples”
                                         shall mean the biological samples collected in connection with a Study.



 


		1.8	“Services”
                                         shall mean the early stage drug development services to be performed by CRO as described
                                         in more detail in each SOW.



 


		1.9	“SOW”
                                         shall mean a Statement of Work entered into by the Parties substantially in the form
                                         of Schedule I and incorporated by reference to this Agreement.



 


		1.10	“Stipend”
                                         shall mean the payments received by Subjects to participate in a Study.



 






     


     

    

 


		1.11	“Site”
                                         shall mean a third-party site or investigator that is contracted by CRO for a multi-site
                                         study.



 


		1.12	“Study”
                                         shall mean a clinical, preclinical, bioanalytical, pharmacokinetic (“PK”)
                                         analysis study program or any research services (such as toxicokinetic (“TK”)
                                         and data management) and all related activities.



 


		1.13	“Subjects”
                                         shall mean any individual enrolled by CRO to whom the Drugs will be given and who may
                                         provide biological substances for analysis of such Drugs.



 


		1.14	“Test
                                         Article” shall mean any Study medications supplied by Sponsor and may include,
                                         in certain situations, materials, special equipment, or other substances supplied by
                                         Sponsor in connection with the preclinical portion of a Study.



 


		2.	SCOPE
OF THE AGREEMENT



 


		2.1	Scope.
                                         This Agreement governs the terms pursuant to which CRO shall perform the Services requested
                                         from time to time by Sponsor as set out in the SOW. The specific details and tasks for
                                         each Service shall be separately negotiated and specified in the SOW’s signed by
                                         both Parties.



 


		2.2	Use
                                         of Affiliates. The Parties agree that Affiliates of Sponsor and/or CRO may enter
                                         into SOW’s, provided that they agree to abide by the terms and conditions of this
                                         Agreement to the extent applicable. Sponsor and CRO shall be responsible for any breach
                                         of this Agreement or any SOW by their respective Affiliates or for any failure to perform
                                         the obligations thereof.



 


		3.	RESPONSIBILITIES
AND OBLIGATIONS OF CRO



 


		3.1	Responsibilities.
                                         CRO shall:



 


		a)	perform
                                         the Services in compliance with the requirements of this Agreement, the SOW’s and
                                         the Protocol;



 


		b)	comply
                                         with all federal, provincial and local laws and regulations applicable to the provision
                                         of Services and generally accepted industry standards, including the ICH guidelines E6
                                         for Good Clinical Practices, applicable requirements as outlined in the FDA, OECD Principles
                                         of Good Laboratory Practices, and the Reflection paper for laboratories that perform
                                         the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010), all relevant
                                         professional standards and guidelines, and all local laws and regulations pertaining
                                         to animal care and use and animal welfare;



 


		c)	exercise
                                         reasonable care and a high standard of professional conduct in the performance of the
                                         Services and ensure that the Services are performed by qualified personnel;



 


		d)	notify
                                         Sponsor of any serious adverse event occurring during the performance of the Services
                                         and, if specified, in the manner that may be specified in the protocol;



 






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		e)	in
                                         connection with the provision of preclinical services, perform the Services in a timely
                                         manner as detailed in the SOW;



 


		f)	in
                                         connection with the provision of clinical services, use its commercially reasonable efforts
                                         to complete recruitment and perform the Services in a timely manner as detailed in the
                                         SOW;



 


		g)	in
                                         connection with the provision of bioanalytical services, perform the analysis of the
                                         Samples in compliance with the bioanalytical method as described in the bioanalytical
                                         plan;



 


		h)	in
                                         connection with the provision of statistical and TK and/or PK analysis services, perform
                                         the analysis in compliance with the statistical analysis plan and/or the PK analysis
                                         plan;



 


		i)	following
                                         completion of the Study or analysis, as applicable, deliver to Sponsor the draft and
                                         final report, or the agreed upon final deliverables if there is to be no report;



 


		j)	notify
                                         Sponsor of any finding that could negatively affect the conduct of the Services or any
                                         finding that could affect the safety of the Subjects, including any safety issue or notice
                                         of defective product, or their willingness to continue their participation in a Study;
                                         and



 


		k)	in
                                         connection with a multi-site study, contract and manage Sites and perform other services
                                         as specified in the SOW.



 


		3.2	Changes
                                         to Services. In the event that Sponsor initiates a change that affects the conduct
                                         of the Services including, without limitation, a change to the Drug, Test Article or
                                         to the Protocol, CRO will prepare a change order to the SOW which shall reflect the adjustments
                                         to the budget and the schedule to be agreed upon in writing. Sponsor shall have ten (10)
                                         days to review and accept this change order. If the change order is not signed, it shall
                                         be deemed to not be accepted and the Sponsor and CRO shall work together to achieve a
                                         mutually acceptable change order. CRO shall not be held responsible for any delay or
                                         non-observance of its deadlines resulting from the changes initiated by Sponsor or resulting
                                         from failure to obtain the necessary information or instructions from Sponsor.



 


		3.3	Repeat
                                         Sample Analysis. If applicable, the parties agree that as of commencement of work,
                                         in some instances, repeat of sample analysis will be required. If this arises, the CRO
                                         will notify the Sponsor as soon as possible and determine, between the parties, if these
                                         repeats are required by the Sponsor. The price per sample analysis/occasion, as indicated
                                         in the applicable SOW, will apply to any additional repeats requested by the Sponsor,
                                         as well as any samples above the analytical range, which require dilution or samples
                                         that are pre-diluted (at the first analysis) at the Sponsor’s request and using
                                         the Sponsor’s dilution factor, if applicable. The CRO will endeavor, as much as
                                         possible, to proceed with current batches of sample analysis at the agreed price per
                                         sample; however, should additional batches be needed a mutually agreeable batch fee will
                                         apply.



 






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		4.	RESPONSIBILITIES
AND OBLIGATIONS OF SPONSOR



 


		4.1	Responsibilities.
                                         Sponsor shall:



 


		a)	provide
                                         CRO in a timely fashion with all information and materials reasonably required to perform
                                         the Services described in the SOW;



 


		b)	comply
                                         with all laws and regulations applicable to the provision of Services;



 


		c)	notify
                                         CRO of any finding that could affect the conduct of the Services or any finding that
                                         could affect the safety of the Subjects, including any safety issue or notice of defective
                                         product, or their willingness to continue their participation in a Study; and



 


		d)	to
                                         the extent a Clinical study report is prepared by CRO, provide CRO with comments on the
                                         draft report within three (3) months after the receipt date of such report. In the event
                                         where CRO does not receive Sponsor’s comment within three (3) months after the
                                         shipment date, CRO reserves the right to finalize and submit the final report to Sponsor.
                                         To the extent a Preclinical or other study report is prepared by CRO, provide comments
                                         on the draft report within thirty (30) days after receipt. If Sponsor’s comments
                                         are not received within thirty (30) days, CRO reserves the right to finalize and submit
                                         the final report to Sponsor. Any amendment requested by Sponsor following the finalization
                                         and submission of the final report shall be subject to additional charges.



 


		4.2	Preclinical
                                         Services. In connection with the provision of preclinical services, CRO shall make
                                         commercially reasonable efforts to, in material accordance with the schedule set forth
                                         in the Protocol, furnish the Sponsor with a draft report and a final report for the Study;
                                         provided, however, CRO shall have no liability to the Sponsor for any delay or failure
                                         to perform the Study in accordance with the Protocol if such delay or failure is a result
                                         of the Sponsor’s failure to duly and timely perform any and all of its obligations
                                         hereunder. One additional revised draft report will be provided upon Sponsor’s
                                         request; additional draft reports will be provided upon request at Sponsor’s additional
                                         cost determined at CRO’ s then prevailing rates. The final report shall summarize
                                         all the material procedures, data, observations and results obtained from the Study,
                                         and CRO shall make commercially reasonable efforts to issue the final report within thirty
                                         (30) days after the Sponsor’s approval of the draft report (which approval may
                                         not be unreasonably withheld, conditioned or delayed).



 


		4.3	Clinical
                                         services. In connection with the provision of clinical services, Sponsor shall:



 


		a)	ensure
                                         that the Drugs supplied to CRO are manufactured and packaged in accordance with the currently
                                         effective Good Manufacturing Practices regulations so that it is suitable for human intake;



 


		b)	ensure
                                         that the storage and transport of the Drugs have been done in compliance with applicable
                                         laws;



 


		c)	provide
                                         all necessary data on Drugs’ formulation stability and storage requirements to
                                         CRO; and



 


		d)	supply
                                         CRO, at least seven (7) days prior to the agreed Dosing Date, with a sufficient quantity
                                         of the Drugs and provide a valid certificate of analysis for the Drugs, which would include
                                         the lot identification and the measured content of the Drugs and, if the certificate
                                         of analysis was issued more than six (6) months prior to the Dosing Date, the stability
                                         data related to such Drugs.



 






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		4.4	Bioanalytical
                                         services. In connection with the provision of bioanalytical services, Sponsor shall,
                                         if the clinical services have been performed by a party other than CRO, inform CRO prior
                                         to the starting date of the Services of any concomitant medication taken by Subjects
                                         during the clinical phase of a Study and compensate CRO for the costs, including but
                                         not limited to the cost of staff, supplies, facilities and instrument usage, incurred
                                         to perform the additional tests required as a result of the intake of such concomitant
                                         medication.



 


		4.5	Research
                                         Services. Support Services (Toxicokinetic/ Pharmacokinetic/ Biostatistics/ Regulatory
                                         Affairs/ Data Management) If Research Services are required as per any SOW, the CRO agrees
                                         to perform the data management, TK/PK and statistical analyses of the data generated
                                         in compliance with the applicable guidelines for submission as asked by the Sponsor and
                                         detailed in the Protocol.



 


		4.6	Adverse
                                         event reporting. Sponsor remains responsible for any adverse event reporting to Health
                                         Canada, Food & Drug Administration or any other regulatory authority in accordance
                                         with applicable laws and regulations.



 


		5.	FINANCIAL
ARRANGEMENTS



 


		5.1	Service
                                         fees and payment milestones. For the Services rendered, Sponsor agrees to pay to
                                         CRO the total fee indicated in the SOW and any other additional fees set forth herein.



 


		5.2	Payment
                                         terms. Payments are due within thirty (30) days of the date of invoice. In the event
                                         of late payment and unless CRO has been notified in writing of any legitimate dispute,
                                         interest on unpaid invoices may be charged at the rate of 1.5% per month, calculated
                                         monthly on a compounded basis, on invoices which remain unpaid after thirty (30) days
                                         from the date of invoice. After ten (10) days from receipt by Sponsor of CRO’s
                                         written notice regarding failure to pay the invoice in due time, CRO retains the right
                                         to delay or stop any Services provided under the SOW and/or retain any results or report.
                                         Additionally, CRO may be entitled to expenses incurred in its efforts to collect unpaid
                                         invoices from Sponsor, if necessary, including, without limitation, court costs and reasonable
                                         legal fees. All payments due shall be made unconditionally without defense, counterclaim,
                                         offset and shall not be conditioned or delayed pending Sponsor’s receipt of payment
                                         from any third party.



 


		5.3	Pass-through
                                         Costs. CRO will separately invoice Sponsor for the expenses incurred during the Services
                                         (the “Pass-through Costs”) that have been agreed to by Sponsor. If applicable,
                                         the estimated Pass-through costs will be outlined in each SOW. The estimated Pass-through
                                         costs are included as an indication; the Sponsor agrees to pay the actual expenses incurred
                                         by the CRO during the services provided that CRO has notified Sponsor in advance of any
                                         material deviation from the estimated Pass-through Costs.



 


		5.4	If/when
                                         study is placed at Altasciences Clinical Kansas Inc., Altasciences Clinical Kansas,
                                         P.A. (“Kansas P.A.”) will perform any part of the Services that constitutes
                                         the practice of medicine, as determined by Kansas law (the “Medical Services”)
                                         as set forth in the applicable SOW.



 






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		5.5	If
                                         the study is multi-site, CRO will administer payments to Sites during the course
                                         of the Study as agreed upon in separate agreements between Sites and CRO that Sponsor
                                         has also approved. Sponsor will advance CRO the fees upon execution of the SOW to facilitate
                                         prompt and timely payments to. Concurrent with CRO’s issuance of payments, CRO
                                         will invoice Sponsor for the same amount to ensure the initial advance is replenished
                                         and Sponsor will pay in accordance with Section 5.2. If the advance balance is not sufficient
                                         to make timely payments to Site, CRO will request additional advance monies. If the balance
                                         is greater than needed, CRO will reduce the advance by requesting a lower replenishment
                                         amount. Sponsor acknowledges and agrees CRO will only pay Site from advances or pre-payments
                                         received from Sponsor for Sites’ services, and that CRO will not make payments
                                         to Sites prior to receipt of sufficient funds from Sponsor. Sponsor agrees and acknowledges
                                         that CRO requires a prepayment to maintain cash neutrality over the term of the Study.
                                         If the Study extends over more than one calendar year, the budget will include an annual
                                         cost adjustment.



 


		6.	GROSS-UP
ON PAYMENTS



 


		6.1	Gross-up
                                         on payments. Any and all payments made by Sponsor under this Agreement shall be made
                                         free and clear of, and without deduction or withholding for or on account of any present
                                         or future taxes, levies, duties, charges, fees, deductions or withholdings, now or hereafter
                                         imposed, levied, collected, withheld or assessed by any governmental authority, excluding
                                         net income taxes or any other taxes imposed on or measured by the net income, profit
                                         or capital of CRO, if applicable. If a deduction or withholding is required by any applicable
                                         law, Sponsor shall:



 


		a)	pay
                                         or cause to be paid to the appropriate authority the amount of the withholding or deduction
                                         by no later than the latest date permitted by that authority (including any extension
                                         of time granted by that authority);



 


		b)	produce
                                         to CRO no later than thirty (30) days after that payment a receipt of that authority
                                         evidencing that it has received the proper amount from Sponsor;



 


		c)	pay
                                         such sums to CRO, as may be necessary so that the net amount received by CRO after all
                                         required deductions or withholdings (including deductions and withholdings for or on
                                         account of taxes on any sums payable under this section) will not be less than the amount
                                         CRO would have received had no such deduction or withholding been required; and



 


		d)	Sponsor
                                         shall indemnify and hold CRO harmless from any liability, resulting from Sponsor’s
                                         failure to make timely payments in accordance with this section. Any penalties, interest
                                         or other liabilities arising from such failure shall be the sole responsibility of and
                                         be paid for by Sponsor.



 






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		7.	CONFIDENTIALITY



 


		7.1	Confidential
                                         Information. For the purpose of this Agreement, “Confidential Information”
                                         shall mean all non-public, confidential and proprietary information disclosed before,
                                         on or after the Effective Date, by a Party or its Representatives (the “Disclosing
                                         Party”) to the other Party or its Representatives (the “Receiving Party”),
                                         whether written or oral, including, without limitation (i) all information concerning
                                         the Disclosing Party’s and its Affiliates’ business affairs including, without
                                         limitation, customers, suppliers, investors, organizational structure, finances, sales,
                                         pricing and commercial strategies; (ii) all scientific or technical information (including
                                         know-how and information concerning manufacturing, production, sourcing of raw material,
                                         chemical compounds, patent applications, assays, test results, data or formula), clinical
                                         and laboratory information (including trial design, protocols, study data, study results
                                         and bioanalytical method) and internal processes and procedures; and (iii) the existence
                                         of this Agreement. The term “Confidential Information” will not include:
                                         (i) information which after disclosure becomes part of the public domain by publication
                                         or otherwise, without breach of this Agreement by the Receiving Party; (ii) information
                                         which the Receiving Party can establish by documentary evidence is known by or in possession
                                         of the Receiving Party before being disclosed by the Disclosing Party; (iii) information
                                         which the Receiving Party developed independently, as established by documentary evidence,
                                         provided that such development is not based in whole or in part on Confidential Information
                                         disclosed by the Disclosing Party; or (iv) information which the Receiving Party receives
                                         from a third party on a non-confidential basis, provided that such third party is not
                                         prohibited from disclosing such information by an obligation of confidentiality to the
                                         Disclosing Party.



 


		7.2	Confidentiality
                                         obligations. The Receiving Party agrees that:



 


		a)	it
                                         will not use the Confidential Information except in connection with the Services and
                                         that it will not use the Confidential Information in any manner that is competitive with
                                         or detrimental to the business or operations of the Disclosing Party;



 


		b)	it
                                         will not disclose any of the Confidential Information to any person or entity without
                                         the prior written consent of the Disclosing Party; provided, however, that Confidential
                                         Information may be disclosed to its Representatives if such persons need to know such
                                         information in connection with the Services, including the Site, if applicable. The Receiving
                                         Party will ensure that its Representatives are bound by confidentiality obligations to
                                         the same extent as if they were parties hereto, and the Receiving Party shall be responsible
                                         for any breach of confidentiality by its Representatives; and



 


		c)	it
                                         will exercise commercially reasonable precautions to physically protect the integrity
                                         and confidentiality of the Confidential Information.



 


		7.3	No
                                         breach of IP. The Disclosing Party represents that the disclosure of Confidential
                                         Information to the Receiving Party does not infringe, violate or misappropriate intellectual
                                         property of any third party and does not violate any contract or obligation to which
                                         the Disclosing Party is a party.



 


		7.4	Term
                                         of confidentiality. This Section 7 (CONFIDENTIALITY) shall apply to any Confidential
                                         Information for a period of ten (10) years from the date of disclosure.



 


		7.5	Ownership.
                                         The Disclosing Party remains the exclusive owner and retains all rights, title and interest,
                                         including intellectual property rights, of the Confidential Information disclosed to
                                         the Receiving Party. All Confidential Information will be promptly returned or destroyed
                                         upon request of the Disclosing Party, except that the Receiving Party may retain copies
                                         of Confidential Information: (i) for the purpose of determining the Receiving Party’s
                                         obligations hereunder; (ii) as required by law; and (iii) that are maintained pursuant
                                         to automatic archiving and back-up procedures.



 






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		7.6	Request
                                         from government. In the event Confidential Information is required to be disclosed
                                         by a governmental agency, the Receiving Party will provide the Disclosing Party with
                                         prompt written notice of such request to enable the Disclosing Party to seek, at its
                                         sole cost and expense, an appropriate protective order or remedy. If the Receiving Party
                                         is required to disclose Confidential Information, it will use commercially reasonable
                                         efforts to disclose only that portion of the Confidential Information as is legally required
                                         to be disclosed.



 


		7.7	Medical
                                         records. In the event Sponsor shall come into contact with a Subject’s medical
                                         records, Sponsor shall hold in confidence the identity of the Subject and shall comply
                                         with all applicable laws regarding the confidentiality of such records, including without
                                         any limitation any privacy laws or regulations.



 


		8.	INTELLECTUAL
PROPERTY



 


		8.1	Initial
                                         IP. Neither Party transfers by operation of this Agreement to the other Party any
                                         patent right, copyright, nor other proprietary right that it owns as of the commencement
                                         of the Services, except as specifically set forth herein.



 


		8.2	Study
                                         Drug. The Parties acknowledge that the Drug, Test Article and/or any material provided
                                         by Sponsor which Sponsor considers to be necessary to and/or useful for CRO for the performance
                                         of the Services are, and shall remain, the exclusive property of Sponsor.



 


		8.3	Study
                                         Data. The Parties agree that Sponsor, upon complete payment of the service fees indicated
                                         in the SOW or upon reimbursement in accordance with Section 5.2, shall own all results,
                                         methods, data, case report forms and other reports completed by CRO pursuant to the Protocol,
                                         Agreement or other written instruction by Sponsor (the “Study Data”) including
                                         all patent and other intellectual property rights therein, excluding the Subjects’
                                         medical records. Upon Sponsor’s prior consent, CRO may use the Study Data for its
                                         own internal, marketing, non-commercial research and educational purposes.



 


		8.4	Other
                                         IP. Other than as specified in Section 8.3. CRO agrees that any intellectual property
                                         arising out of Services performed hereunder that are dependent on Sponsor’s patent
                                         claims or are expressly anticipated by the Protocol and/or the bioanalytical plan and/or
                                         statistical analysis plan and/or the PK analysis plan, as applicable, shall be owned
                                         by Sponsor and shall be promptly disclosed by CRO to Sponsor.



 


		9.	STORAGE



 


		9.1	Documentation.
                                         CRO will maintain documentation for the Services in accordance with all applicable authorities’
                                         regulations or as outlined in the SOW. CRO will notify Sponsor in the event any additional
                                         charges will be incurred due to large volumes or extended durations, in which the parties
                                         will agree to any additional charges in writing.



 


		9.2	Test
                                         Article. CRO will store, destroy or return Test Article after completion of study
                                         as indicated in the applicable SOW and/or Quotation.



 






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		9.3	Drugs.
                                         CRO will maintain complete and accurate inventory of the Drugs received from Sponsor



 


		a)	For
                                         a FDA submission, CRO will keep in adequate storage a reserve quantity of the Drugs in
                                         accordance with 21 CFR 320. Following the retention period, Sponsor will be contacted
                                         to complete the Drug Disposition Form. Any other remaining unused Drug will be destroyed
                                         or returned to Sponsor (at Sponsor’s cost), as indicated on the provided Drug Disposition
                                         Form. Should a response not be received from Sponsor within thirty (30) days of request
                                         to complete the Drug Disposition Form, or should the Sponsor require extended storage
                                         of the remaining unused Drug, CRO will store the Drugs at the rate indicated in the applicable
                                         SOW.



 


		b)	For
                                         TPD or EMA submissions, CRO will contact Sponsor to confirm if the Drugs should be stored
                                         at a rate per the applicable SOW, destroyed on site, or returned to Sponsor (at Sponsor’s
                                         cost). Should a response not be received from Sponsor within thirty (30) days, CRO will
                                         automatically store the Drugs at a rate indicated in the applicable SOW.



 


		c)	For
                                         ANVISA submissions, CRO will retain a quantity of the Drugs necessary to repeat the Study
                                         as per ANVISA requirements until the Drugs expire. After the Drugs expire CRO will contact
                                         Sponsor to confirm if the Drugs should be stored at a rate per the applicable SOW, destroyed
                                         on site, or returned to Sponsor (at Sponsor’s cost). Should a response not be received
                                         from Sponsor within thirty (30) days, CRO will automatically store the Drugs at a rate
                                         indicated in the applicable SOW.



 


		9.4	Samples.
                                         CRO will maintain complete and accurate inventory of the Samples collected in connection
                                         with the Services. Preclinical samples will be stored as indicated in the Protocol and/or
                                         the SOW, as applicable. For clinical studies, upon shipment of the draft Bioanalytical
                                         report, CRO will keep in adequate storage, at its own cost, all the Samples for a period
                                         of three (3) months. CRO will contact Sponsor to confirm if the Samples should be stored
                                         at the then current storage rate or the rate indicated in the applicable SOW and/or Quotation,
                                         destroyed or returned to Sponsor (at Sponsor’s cost). Should a response not be
                                         received from Sponsor, before the end of the free storage period, CRO will automatically
                                         store the Samples at the applicable rate. At any time, Sponsor may terminate the storage
                                         of the Samples by sending a written notice to CRO, instructing CRO to destroy the Samples
                                         or to ship the Samples to Sponsor or to a third party. In such case, all shipping charges
                                         are the responsibility of Sponsor.



 


		10.	LIMITATIONS
TO SERVICES



 


		10.1	CRO’s
                                         obligation. CRO’s obligation under this Agreement and any related SOW is limited
                                         to performing the Services in accordance with this Agreement, the Statements of Work
                                         and Protocol, while ensuring the conduct of the Services in compliance with applicable
                                         laws and regulations and generally accepted industry standards.



 


		10.2	Physician
                                         Services. The Sponsor acknowledges that CRO will not, in any event, be liable for
                                         the Physician Services rendered by Kansas P.A. in accordance with Section 5.4.



 






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		10.3	No
                                         specific results. CRO does not give any representation or warranty that specific
                                         results can be achieved or that the Drugs or Test Article covered by any SOW can, either
                                         during the term of the SOW or thereafter, be successfully manufactured or receive the
                                         required approval by drug administration authorities or any regulatory bodies.



 


		10.4	Number
                                         of Subjects. In the event that CRO fails to meet the Protocol requirements on the
                                         number of Subjects to be recruited, Sponsor will be given the option to extend the recruitment
                                         period or to continue the Study with less Subjects.



 


		10.5	OTHER
                                         THAN THE WARRANTIES EXPRESSLY STATED IN SECTIONS 3, 4, AND 10, THERE ARE NO EXPRESSED
                                         OR IMPLIED WARRANTIES RELATED TO ANY OF THE SERVICES COVERED BY THIS AGREEMENT OR ANY
                                         STATEMENT(S) OF WORK.



 


		11.	INDEMNIFICATION



 


		11.1	Sponsor’s
                                         indemnification. Sponsor shall defend, indemnify and hold harmless CRO and its Representatives
                                         from any loss, expense (including reasonable defense cost), cost, liability, damage,
                                         claim, action or suit, including but not limited to any personal injuries, death, or
                                         property damage, arising directly out of: 1) the negligence or wrongful acts or omissions
                                         of Sponsor or its Representatives, 2) any defect, deficiency, malfunction, hazard or
                                         adverse reactions in or resulting from the Drug or any equipment and supplies provided
                                         or manufactured by Sponsor in connection with the Services, and 3) any material breach
                                         by Sponsor or its Representatives of any of its obligations or duties under this Agreement.



 


		11.2	CRO’s
                                         indemnification. CRO shall defend, indemnify and hold harmless Sponsor and its Representatives
                                         from any loss, expense (including reasonable defense cost), cost, liability, damage,
                                         claim, action or suit arising directly out of: 1) the negligence or wrongful acts or
                                         omissions of CRO or, its Representatives, affiliates, assignees, subcontractors or successors
                                         and 2) any material breach by CRO or its Representatives, affiliates, assignees, subcontractors
                                         or successors of any of its obligations or duties under this Agreement.



 


		11.3	Limitations.
                                         Section 11.1 and 11.2 are subject to the following limitations:



 


		a)	In
                                         no event shall any Party be liable for any incidental, consequential, special or punitive
                                         damages, including but not limited to loss of revenue or profit.



 


		b)	The
                                         parties agree that the CRO liability towards Sponsor pursuant to Section 11.2 shall not
                                         exceed the fees paid by the Sponsor to the CRO in respect of the relevant SOW under this
                                         Agreement, and not to exceed a total amount of three million dollars ($3,000,000 USD).



 


		c)	Third
                                         Party Indemnification. For Multi-Site studies, if Site requests an indemnification
                                         for loss or damage caused by Sponsor’s Project, then Sponsor shall provide such
                                         indemnification directly to the Site. CRO shall not sign or assume such indemnifications
                                         on Sponsor’s behalf.



 


		11.4	Notifications.
                                         Any indemnified Party will promptly notify the indemnifying Party of any claim as to
                                         which indemnified Party intends to seek indemnification from indemnifying Party. Each
                                         Party shall fully cooperate with the other Party in defending any claim as to which a
                                         notice of intent to seek indemnification is provided and will make no compromise or settlement
                                         without the prior written approval of the other Party.



 






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		11.5	Medical
                                         expenses. Sponsor shall reimburse each Subject for any reasonable and necessary medical
                                         expenses incurred for any medical care, including hospitalization, required as a result
                                         of Drugs following their administration or use in accordance with the Protocol, to the
                                         extent such expenses are not covered by the Subject’s medical or hospital insurance
                                         coverage and are in no way attributable to the gross negligence or intentional misconduct
                                         of CRO or its Representatives. The Parties agree that (a) medical care for the natural
                                         progression of an underlying pre-existing condition and (b) alleged lack of efficacy
                                         of Drug are not covered under this Section.



 


		12.	INSURANCE



 


		12.1	CRO
                                         insurance. CRO represents that it carries professional liability insurance for a
                                         limit up to five million dollars ($5,000,000 USD). To the extent any work is performed
                                         in the United States, worker’s compensation insurance shall be maintained in the
                                         applicable statutory limits.



 


		12.2	Sponsor
                                         insurance. Sponsor represents that it carries and shall carry for the term of this
                                         Agreement general liability and product liability insurance coverage for a sufficient
                                         limit to cover Sponsor’s total liability under this Agreement. Sponsor warrants
                                         that, in addition to its liability insurance, it has the financial capacity to compensate
                                         any claim for which it is responsible that may exceed the coverage of its insurance policy.
                                         The insurance policy shall be valid in Canada if Studies are performed in Canada and/or
                                         valid in the United States if studies are performed in the United States and have a limit
                                         of at least five million dollars ($5,000,000 USD). Upon signature of a SOW or upon request
                                         of the CRO, Sponsor shall furnish a certificate of insurance acceptable to CRO indicating
                                         the required coverage. Sponsor will promptly notify CRO of any notice of cancellation
                                         or non-renewal of, or material change in, or claim against, its insurance coverage.



 


		12.3	Sponsor
                                         insurance for multi-site studies. In connection with a multi-site study, in the terms
                                         of Section 12.2 apply, however, Sponsor represents that it carries and shall carry for
                                         the term of this Agreement, general liability in amounts of at least three million dollars
                                         ($3,000,000 USD) and product liability insurance coverage in amounts of at least ten
                                         million dollars ($10,000,000 USD). Sponsor represents and warrants that it will (i) maintain
                                         product liability insurance that does not contain any conditions or exclusions in the
                                         policy that would not normally be included in insurance of this type, and (ii) include
                                         CRO as an additional insured on all applicable clinical trials and/or product liability
                                         policies. Insurance coverage and indemnification obligations will be outlined in a separate
                                         agreement between Sponsor and Site.



 


		13.	AUDIT



 


		13.1	Visits.
                                         Upon reasonable notice, Sponsor and its Representative may visit and inspect the CRO
                                         facilities during CRO’s normal business hours and in compliance with CRO’s
                                         then current site requirements in order to maintain current and personal knowledge of
                                         the conduct of Services through review of the records, comparison with source documents,
                                         observation and discussions. CRO will fully cooperate in any monitoring, audit or inspection
                                         by a regulatory agency in connection with the provision of Services.



 






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		13.2	Inquiries.
                                         CRO agrees to answer in a timely manner any questions coming from regulatory authorities
                                         and/or Sponsor which are Services-related and within the original scope of work. Following
                                         completion of the Services specified in the SOW, CRO reserves the right to request compensation
                                         for any additional analysis or additional supporting documents required by regulatory
                                         authorities and/or Sponsor.



 


		14.	TERM,
TERMINATION, SUSPENSION AND POSTPONEMENT



 


		14.1	Term.



 


		a)	This
                                         Agreement shall enter into force on the Effective Date and shall continue following three
                                         years from the Effective Date, unless terminated by both Parties, in which case the rights
                                         and obligations under this Agreement shall remain in full force and effect until the
                                         termination of all outstanding SOWs.



 


		b)	Statements
                                         of Work shall enter into force upon signature and shall continue thereafter until the
                                         date of acceptance by Sponsor of final report, or final deliverable if no report, unless
                                         terminated earlier either jointly by both Parties or by any Party pursuant to Section
                                         14.2 or 14.3.



 


		14.2	Termination
                                         by Sponsor. Sponsor may terminate a SOW, effective upon written notice to CRO:



 


		a)	if
                                         the execution of the Services is no longer of technical or commercial interest.



 


		b)	if
                                         CRO breaches this Agreement, the SOW or the Protocol in a way that materially impacts
                                         the Services, and (i) such breach is incapable of cure, or (ii) with respect to a breach
                                         capable of cure, CRO does not cure the breach within thirty (30) days after receipt of
                                         written notice of such breach.



 


		14.3	Termination
                                         by any Party. Any Party may, acting reasonably, terminate a SOW effective upon written
                                         notice to the other Party if any safety issue arises or in order to comply with any law,
                                         regulation or decision of any judicial authority.



 


		a)	Either
                                         Party may terminate this Agreement or any SOW at any time in its sole discretion, upon
                                         giving thirty (30) days prior written notice to the other party.



 


		b)	If
                                         CRO encounters any difficulties beyond its reasonable control (including without limitation
                                         any Force Majeure event) in performing any of the Studies in accordance with the Protocol,
                                         CRO shall notify the Sponsor in writing, and the parties shall make good faith efforts
                                         to resolve or overcome such difficulties by amending the Protocol or otherwise. If such
                                         difficulties cannot be resolved or otherwise eliminated to CRO’s reasonable satisfaction,
                                         or if the Sponsor fails to duly and timely perform any and all of its obligations hereunder,
                                         CRO shall have the right to terminate the SOW upon giving thirty (30) days prior written
                                         notice to the Sponsor.



 


		14.4	Consequences.
                                         In the event of termination:



 


		a)	Sponsor
                                         shall reimburse CRO all incurred fees for Services performed and expenses and costs incurred
                                         prior to the termination, including non-cancellable obligations incurred prior to such
                                         termination. Such fees, expenses and costs shall include, but not be limited to administrative
                                         expenses, items procured, Services undertaken, and all non-cancellable obligations incurred
                                         specifically for the Services (e.g., animal purchases and animal expenses, including
                                         animal disposition, as well as specialized supplies and/or equipment.)



 






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		b)	For
                                         clinical and clinical related services, the following costs outlined above shall apply
                                         for termination/postponement by the Sponsor and the following termination/ postponement
                                         fees:



 


	Days
    before dosing	Postponement/Termination
    Fees
	More
    than 42 days	0%	Of
    total Study Fee (less Subject Stipends and less bioanalytical fees)
	29
    to 42	5%
	15
    to 28	10%
	8
    to 14	20%
	1
    to 7	30%


 


		c)	For
                                         animal studies, study delay and cancellation charges will be assessed as follows:



 


	Days
    Of Notice Given Prior To The Scheduled Start Of Study Acclimation	Delay
                                         Or Cancellation Charge, % Of Total Study Price

         

	1-14	50%
    + animal costs
	15-28	30%
    + animal costs
	29-42	20%
    + animal costs
	43-56	10%
    + animal costs
	57-70	5%
    + animal costs
	71+	0%
    + animal costs*
	 	 


 


*Should
any animal costs and/or additional applicable fees be charged by the animal supplier before animals are on site, these will be
passed on to the Sponsor.


 


		d)	If
                                         the Study is terminated prematurely because the Study is no longer of technical or commercial
                                         interest by the Sponsor after the dosing date, then the Sponsor will pay to the CRO the
                                         costs related to pre-study activities and completed study activities plus 60% of total
                                         study cost (minus Bioanalytical Operations & Volunteer Indemnification).



 


		14.5	Suspension
                                         for safety. CRO shall be entitled to suspend the Services without notice and without
                                         engaging its liability for such suspension if, to its reasonable opinion, there is a
                                         safety issue arising which can affect the safety of the Subjects. If it occurs that the
                                         suspected danger is averted, the suspension will end and the Services will be resumed.
                                         If it occurs that the suspected danger is confirmed, the suspension will end and either
                                         Party will be enabled to terminate the Services as per Section 14.3.



 


		14.6	Postponement
                                         by Sponsor. Sponsor may postpone the Services, provided that Sponsor pays postponement
                                         fees in the same amount as terminations fees set forth in Section 14.4.



 






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		14.7	Pass-through
                                         Costs. Upon early termination of any SOW in accordance with Section 14.2 or 14.3,
                                         CRO will invoice to Sponsor all unavoidable Pass-through Costs that were incurred up
                                         to termination.



 


		14.8	Impact
                                         on Study. If clinical services are provided, immediately upon receipt of a written
                                         notice of termination by Sponsor, CRO shall promptly stop entering Subjects into the
                                         Study and shall cease conducting procedures on Subjects already entered in the Study,
                                         provided that CRO shall complete Study procedures for any Subject as to whom it determines
                                         in his sole discretion that completion is medically necessary. Upon payment, CRO shall,
                                         upon request, furnish to Sponsor all case report forms, either completed or uncompleted,
                                         up to the date of the Study termination, as well as all other Study materials.



 


		15.	ASSIGNMENT,
SUBCONTRACTING AND CHANGE OF CONTROL



 


		15.1	Affiliates.
                                         This Agreement and all rights and obligations hereunder, shall not be assigned by either
                                         Party without prior written notice to the Parties hereto. Notwithstanding the foregoing,
                                         CRO may assign, transfer, delegate and subcontract all or any part of the portion of
                                         the Services to any of its Affiliates. In such case, such Affiliate shall (i) abide by
                                         the terms and conditions of this Agreement and (ii) be entitled to the rights and benefits
                                         of CRO under this Agreement, including the right to enforce any terms of this Agreement.
                                         Furthermore, CRO may assign its rights and obligations under this Agreement, without
                                         the prior written consent of the Sponsor, to a successor including, without limitation,
                                         by reason of merger, amalgamation, corporate reorganization, sale of all or substantially
                                         all of the its assets or portion of its business which relates to the Services provided
                                         herein.



 


		15.2	Subcontractors.
                                         Provided Sponsor has consented in writing, CRO may subcontract or delegate the performance
                                         of all or part of the Services under this Agreement to a third-party subcontractor, and
                                         provided that such subcontractor perform such activities in a manner consistent with
                                         the terms and conditions in this Agreement and that CRO shall remain liable for any non-performance
                                         or breach of the terms of this Agreement by the subcontractor.



 


		15.3	Change
                                         of control and bankruptcy. Either party may terminate this Agreement and any SOWs
                                         in the event of a change of control of the other party hereto, or if the other party
                                         becomes insolvent, or a enters into a proceeding in bankruptcy, receivership or similar
                                         proceeding is filed involving the other party during the term of this Agreement.



 


		16.	MISCELLANEOUS



 


		16.1	Entire
                                         Agreement. This Agreement, together with all schedules and Statements of Work, constitutes
                                         the sole and entire agreement of the Parties with respect to the subject matter contained
                                         herein, and supersedes all prior and contemporaneous understandings and agreements, both
                                         written and oral, with respect to such subject matter, except any confidentiality agreement
                                         still outstanding between the Parties, which shall complete the provisions of this Agreement.
                                         The terms of this Agreement shall control in the event of a conflict with the terms of
                                         a SOW.



 


		16.2	Relationship
                                         between the Parties. CRO shall perform all the Services as an independent contractor.
                                         Neither CRO nor Representatives are employees, partners, representatives, or joint venturers
                                         of or with Sponsor, and nothing in this Agreement shall be construed to create such a
                                         relationship. CRO shall be solely responsible for the manner and working hours in which
                                         it will perform the Services. It is the intention of the Parties that no form of legal
                                         agency relationship be created between the Parties and nothing in this Agreement shall
                                         be deemed to create in either Party the right or authority to incur any obligation on
                                         behalf of the other Party or to bind such other Party in any way whatsoever except in
                                         accordance with the terms of this Agreement.



 






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		16.3	Notices.
                                         All written notices from one Party to the other under this Agreement are sufficient as
                                         sent by email, unless otherwise specified in the Protocol or otherwise requested by Sponsor.



 


		16.4	Force
                                         majeure. Neither Party shall be held liable for non-fulfilment or delayed performance
                                         of the Agreement or part thereof due directly or indirectly to any cause outside the
                                         reasonable control of either Party, and which the affected Party was unable to foresee
                                         at the time of the signing of the SOW; provided that: (a) notice of its inability to
                                         perform and the causes thereof shall be provided immediately by the affected Party to
                                         the other; and (b) if such inability to perform shall continue for a period of three
                                         (3) months, the other Party shall have the right to terminate the SOW by written notice
                                         at any time thereafter.



 


		16.5	Severability
                                         and waiver. The invalidity, illegality or unenforceability of any term or provision
                                         of this Agreement shall not affect the validity, legality or enforceability of any other
                                         term or provision hereof. No waiver by any Party of any provisions of this Agreement
                                         shall be effective unless explicitly set forth in writing and signed by the Party so
                                         waiting. Except as set forth in this Agreement, no failure to exercise, or delay in exercising,
                                         any right, remedy, power or privilege arising from this Agreement shall operate or be
                                         so construed as a waiver thereof, nor shall nay single or partial exercise of any right,
                                         remedy, power or privilege hereunder preclude any other or further exercise thereof or
                                         the exercise of any other right, remedy, power or privilege.



 


		16.6	Amendment.
                                         The Agreement may not be modified or amended except by a written agreement signed by
                                         both Parties.



 


		16.7	Successor
                                         and assigns. This Agreement will be binding upon each Party and their permitted successors
                                         and assigns, and will inure to the benefit of each Party and their successors and assigns.



 


		16.8	Survival.
                                         The rights and obligations of the Parties set forth in Sections 5.1, 7, 8, 9, 10, 11,
                                         12, 13, 14 and 16.9 and any right or obligation of the Parties in this Agreement which,
                                         by its nature, should survive termination or expiration of this Agreement, will survive
                                         the termination or expiration of this Agreement.



 


		16.9	Governing
                                         Laws and forum. This Agreement is governed by and construed in accordance with the
                                         laws of Alberta, without giving effect to any conflict of law principles. The Parties
                                         will use commercially reasonable efforts to settle all matters in dispute amicably and
                                         hereby agree that any dispute arising under this Agreement, or in connection with any
                                         breach thereof, shall be finally resolved through the courts of Alberta.



 






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		16.10	Counterparts.
                                         This Agreement may be executed in counterparts, each of which is deemed an original,
                                         but all of which together are deemed to be one and the same agreement. Signatures to
                                         this Agreement delivered by facsimile or similar electronic transmission (eg. Portable
                                         document format (PDF)) shall be deemed as binding as the original.



 


(Signatures
to follow)


 




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IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by duly authorized representatives.


 





	XORTX Therapeutics Inc.	 	ALTASCIENCES COMPANY INC.
	 	 	 	 	 
	By: 	/s/ Allen
    Davidoff 	 	By: 	/s/ Elizabeth
    Pivetta 



 


	Name: 	Allen Davidoff 	 	Name:  	Elizabeth
    Pivetta 
	 	 	 	 	 
	Title: 	CEO 	 	Title: 	Associate Director, Contracts
    and Client  Experience 
	 	 	 	 	 
	Date: 	Dec 22, 2021 	 	Date:  	12/22/2021 



 






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