Exhibit
4.20



 


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.


 







Combined
Master Services Agreement


 


This
Agreement is made on 19th July 2021


 


Between


 


		(1)	Quotient
                                         Sciences Limited a company registered in England and Wales with registered number
                                         05221615 whose registered office is at Trent House, Mere Way, Ruddington Fields Business
                                         Park, Ruddington, Nottingham, NG11 6JS, United Kingdom (“Quotient”);
                                         and



 


		(2)	XORTX
                                         Therapeutics Inc. a company registered in British Columbia whose registered office
                                         is at Suite 4000, 421 — 7th Avenue S.W, Calgary, Alberta, T2P 4K9 (“Customer”);



 


Recitals


 


		(A)	Quotient
                                         and its Affiliates are engaged in developing formulations and conduct of clinical research
                                         in relation to pharmaceutical products.



 


		(B)	Customer
                                         is engaged in developing pharmaceutical products.



 


		(C)	Quotient
                                         and Customer wish to establish an ongoing relationship under which, from time to time,
                                         Customer may request that Quotient performs research and other services in relation to
                                         the Customer’s pharmaceutical products. They have agreed to contract to set out
                                         the terms of such relationship.



 


It
is agreed


 


		1.	Definitions
                                         ABPI means the Association of British Pharmaceutical Industry in the United Kingdom.



 


Affiliate(s):
For this Agreement, an Affiliate of a Party is any person, corporation, joint venture, or other business entity that directly
(or indirectly through one or more intermediaries) controls, is controlled by, or is under common control with such Party. For
the preceding definition only, the terms “controls,” “controlled,” and “control” shall mean
possessing the power to direct or cause the direction of the management and policies of an entity, whether through ownership or
control of stock (or other ownership interest), by contract, or otherwise.


 


Agreement
means this Master Services Agreement and its appendices.


 


Background
Material means any and all data, materials, formulation methods, software, know-how, and other Intellectual Property, trade
secrets, product samples, prototypes, processes, analyses, reports, manufacturing techniques, compilations, research notes, technology,
equipment, providers, inventions and/or discoveries which is/are in existence at the date of this Agreement or which is/are developed
or arise(s) independently of any Research.






    


     


    




Background
Intellectual Property means any Intellectual Property in relation to any Background Material.


 


Clinical
Protocol means a protocol for the conduct of Clinical Research agreed in writing between the Parties.


 


Commencement
Date means the date of this Agreement set out above.


 


Confidential
Information means the Background Material, Intellectual Property and all information disclosed by one Party to the other in
relation to the Research including, but not limited to, Research Output, Materials, the Clinical Protocol, communications with
the competent authorities and Ethics Committees, customers, suppliers or employees, sales and marketing information.


 


Customer
Data means documents, data and information relating to any Materials and/or Research.


 


Force
Majeure means any circumstance beyond the reasonable control of the Party affected by it and includes, strikes, lockouts,
industrial disputes, telecommunications failure, power supply failure, computer breakdown, restrictive government or judicial
orders or decrees, riots, insurrection, war, terrorism, Acts of God and failure of suppliers to meet delivery requirements and
absence of personnel due to illness or injury.


 


Good
Clinical Practice means good clinical practice as set out in the ICH guidance on Good Clinical Practice as defined in ICH
Guideline topic E6 on “Good Clinical Practice”, Directive 2005/28/EC laying down principles and detailed guidelines
for good clinical practice as regards investigational medicinal products for human use.


 


Good
Manufacturing Practice means current good manufacturing practice as appropriate to the location where the Services are performed
consistent with (i) Directive 2003/94/EC and the requirements defined in: The Rules Governing Medicinal Products in the European
Community Volume 4, including the Investigational Medicinal Products Annex 13, and as applied to APIs for Use in Clinical Trials,
as covered within the EU Guidance to Good Manufacturing Practice Part II, Section 19 and ICH Q7 Section 19 or (ii) good manufacturing
regulations as set out by the US FDA.


 


Intellectual
Property means all patents, trade marks or trading names (whether or not registered), rights in know-how, design rights (whether
or not registered), copyright, database rights, rights in inventions and know-how, all applications for the same and all rights
having equivalent or similar effect, in each case subsisting at any time, anywhere in the world.


 


Materials
means any materials and/or substances which are the subject of Research.


 


Non-Cancellable
Costs means any costs and/or expenses to which Quotient is committed by this Agreement or any Work Order on behalf of Customer
and which cannot be cancelled. Such Non-Cancellable Costs will be detailed within the Work Order and shall always include Quotient’s
or Service Providers’ costs of labour and/or materials during such delay.






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Payment
Schedule means the document set out at Appendix 2 of a Work Order.


 


Personal
Data means personal data as defined under the UK Data Protection Act 2018 and any successor legislation and, where applicable,
the General Data Protection Regulation ((EU) 2016/679).


 


Proposal
means the proposal and costing document set out at Appendix 1 of a Work Order.


 


Regulations
means the Medicines for Human Use (Clinical Trials) Regulations 2004.


 


Research
means any clinical trial, study and/or services to be carried out by Quotient set out in the Proposal.


 


Research
Output means any data, and/or materials produced by Quotient, in the course of and relating to Research (whether individually,
collectively or jointly with the Customer and on whatever media), which it must deliver to the Customer under the Proposal, including,
without limitation, any reports and case report forms, but excluding any Background Materials.


 


Service
Providers means Affiliates, subcontractors (of whatever level) and agents of Quotient and their employees.


 


Sponsor
has the meaning given to it in the Regulations.


 


Term
means the period of five (5) years from the Commencement Date.


 


Trial
Subject means a person who is administered and/or who consumes any Materials in connection with the Research.


 


Work
Order means a document (in substantially the same form as that set out in Schedule 1) which has been issued by Quotient and
agreed by both Parties as envisaged under Clause 2.1.


 


		2.	The
                                         Research



 


		2.1	In
                                         consideration of the first Work Order the Parties agree that if, during the Term, Quotient
                                         will perform any particular trial, study and/or services for the Customer, a document
                                         in substantially the form set out in Schedule 1 to this Agreement will be completed and
                                         issued by Quotient in relation to such trial, study and/or services, and will be signed
                                         by both Parties. Each such Work Order will constitute a separate contract between the
                                         Parties for the performance by Quotient and its Service Providers of the Research, and
                                         the payment by the Customer of the amounts set out in the Proposal (and the performance
                                         by the Customer of it’s other obligations), under this Agreement and the Work Order
                                         (to the exclusion of any other terms and/or conditions which the Customer may attempt
                                         or purport to impose).







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		2.2	Quotient
                                         and its Service Providers shall carry out all Research in accordance with the Agreement,
                                         the Work Order, relevant Clinical Protocol and with reasonable skill and care and in
                                         accordance with the Regulations appropriate to the jurisdiction where the Research is
                                         to be performed including, Good Clinical Practice, Good Manufacturing Practice, and according
                                         to all relevant ICH guidelines



 


		2.3	Quotient
                                         must inform Customer within 2 days of any serious adverse events and significant deviations
                                         from, or breaches of the standards applied to the Services including Regulations, the
                                         Clinical Protocol and a Work Order of this Agreement, to enable Customer to meet its
                                         requirements for reporting such events to the applicable Regulatory Authority.



 


		2.4	Quotient
                                         shall use its reasonable endeavours to carry out all Research and to deliver the Research
                                         Output in accordance with the Proposal.



 


		2.5	All
                                         services to be provided by Quotient under this Agreement and any Work Order will be deemed
                                         provided at the Customer’s request and the Customer accepts that it is responsible
                                         for verifying that those services are suitable for its own needs.



 


		2.6	The
                                         Customer may prior to and/or during the performance of any Work Order under this Agreement
                                         and for the requisite period thereafter, audit Quotient’s performance of any Research
                                         upon giving Quotient reasonable prior written notice. The Customer shall use its reasonable
                                         endeavours not to cause any disruption to Quotient’s business in carrying out such
                                         audit.



 


		2.7	The
                                         Customer shall ensure that its employees co-operate fully with Quotient and any Service
                                         Providers in relation to the provision of any Research (including without limitation
                                         complying with Quotient’s normal and reasonable codes of staff and security practice
                                         whilst at Quotient’s sites). The Customer shall comply with its obligations as
                                         set out in any Proposal promptly.



 


		2.8	The
                                         Customer shall provide to Quotient:



 


		(a)	all
                                         information and support necessary to enable Quotient to fulfil its obligations under
                                         the Regulations in relation to the Research including completing any necessary applications
                                         or notifications to the regulatory authority under the Regulations, any Ethics Committee,
                                         any other investigator, any medical practitioner and/or any person subject to or connected
                                         with the Research; and



 


		(b)	during
                                         the Research and during preparing any report relating to the same, with all information
                                         and data relating to the safety and safe usage of the Materials, including and in particular
                                         all relevant preclinical and clinical pharmacovigilance information and data which it
                                         has in its possession and that relates to or may affect the Research, Materials, and/or
                                         the health and safety of any individual whether before after or during any clinical trial.







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The
Customer warrants that all such data and information is and will at all times be accurate, complete and not false or misleading.


 


		2.9	Subject
                                         to this Clause 2.9, if a Work Order provides that Quotient will act as the Legal Representative
                                         of the Customer for the Research, Schedule 2 shall apply to that Work Order. To avoid
                                         doubt, the Customer agrees that it shall be the Sponsor in relation to all Research and
                                         that Quotient is not taking on any Sponsor obligations under this Agreement or any Work
                                         Order. The Customer shall ensure that it complies with its obligations under the Regulations
                                         and with all other applicable laws and regulations. The Customer acknowledges that it
                                         shall be solely responsible for ensuring that it has all licences, permissions and authorisations
                                         necessary to carry out and to allow Quotient to carry out all Research and that any Clinical
                                         Protocol reflects all the requirements of the Regulations.



 


		2.10	Use
                                         of Affiliates.



 


The
Parties Agree that:


 


		(a)	Quotient
                                         may use the services of Quotient’s Affiliate(s) to fulfil Quotient obligations
                                         under this Agreement. In such event:



 


		(i)	the
                                         Quotient Affiliate is to be identified on the Work Order they will be performing under;



 


		(ii)	any
                                         Quotient Affiliate completing Research shall be bound by the terms applicable to Quotient
                                         under this Agreement and entitled to the rights and protections afforded Quotient under
                                         this Agreement; and



 


		(iii)	Quotient
                                         shall be responsible for the performance of its Affiliate.



 


		(b)	Customer’s
                                         Affiliate may use the services of Quotient (and its Affiliate) and such Customer Affiliate
                                         may enter into Work Orders with Quotient under this Agreement. In such event:



 


		(i)	the
                                         Customer Affiliate is to be identified on the Work Order the Research will be performed
                                         under;



 


		(ii)	Customer’s
                                         Affiliate(s) shall be bound by the terms applicable to Customer under this Agreement
                                         and entitled to all rights and protections afforded Customer under this Agreement; and



 


		(iii)	Customer
                                         shall be responsible for the performance of its Affiliate.



 


		(c)	Customer
                                         may directly retain a Quotient Affiliate for the performance of Research under this Agreement,
                                         by such Quotient Affiliate entering into a Work Order to perform Research. Each Quotient
                                         Affiliate that enters into a Work Order shall be bound by this Agreement and shall have
                                         the rights and obligations of Quotient under this Agreement regarding such Work Order.
                                         The execution of a Work Order between Customer and Quotient Affiliate shall be evidence
                                         of their consent to be so bound.







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		(d)	Notwithstanding
                                         anything to the contrary herein, Quotient shall have no liability regarding any Work
                                         Order entered into directly between Customer and a Quotient Affiliate except as otherwise
                                         agreed in writing.



 


		2.11	The
                                         Customer shall promptly notify Quotient of these events in relation to the Research to
                                         enable Company to comply with its regulatory obligations under FDA Final Rule on 21 CFR
                                         320, published in the Federal Register of 28 April 1993 for retention of bioavailability
                                         and bioequivalence reserve samples:



 


		(a)	discontinuance
                                         of the development of the Research Output;



 


		(b)	submission
                                         of an application for approval of the Research Output;



 


		(c)	date
                                         of approval of an application for the Research Output;



 


		(d)	withdrawal
                                         of an application for the Research Output; and



 


		(e)	date
                                         of communication from the regulatory authority documenting that the application is not
                                         approved for the Research Output.



 


		2.12	Quality
                                         Unit



 


All
GMP and GCP Research will be conducted under the oversight of the Quotient Quality Unit. A quality agreement will be completed
between Quotient and Customer, prior to any GMP or GCP activities.


 


		3.	Payment



 


		3.1	The
                                         Customer shall pay all Quotient’s invoices within 30 days from the date of such
                                         invoice.



 


		3.2	Quotient
                                         shall send all invoices to the Customer in accordance with the Payment Schedule. All
                                         charges set out in this Agreement and/or any Work Order are exclusive of Value Added
                                         Tax or any similar taxes, levies or duties, for which the Customer will be additionally
                                         liable.



 


		3.3	If
                                         any undisputed payment due to be made under this Agreement and/or a Work Order is unpaid
                                         for 30 days after receipt of the invoice:



 


		(a)	Quotient
                                         reserves the right to charge interest thereon, after and before any judgement, on a day
                                         to day basis at an annual rate of 4% above the National Westminster Bank plc’s
                                         base rate until the sum is paid; and



 


		(b)	Quotient
                                         may suspend all work under this Agreement and any Work Order until payment has been made
                                         or arrangements as to payment or credit have been established which are satisfactory
                                         to Quotient, provided that the safety and well-being of Trial Subjects is not put at
                                         risk.







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		3.4	Quotient’s
                                         base currency is GBP. Where the project budget is specified in another currency (e.g.
                                         USD or Euros), the exchange rate used to calculate the budget will be specified in the
                                         Work Order or Proposal (the “Reference Exchange Rate”). If a movement in
                                         exchange rates occurs (as shown at www.xe.com) of greater than 5% from the Reference
                                         Exchange Rate during the term of the project, Quotient reserves the right to re-calculate
                                         any project milestones yet to be invoiced based upon the prevailing exchange rates.



 


		4.	Supply
                                         of Materials and Customer Data



 


		4.1	The
                                         Customer shall promptly supply to Quotient, free, all Materials and a copy of Customer
                                         Data reasonably required by Quotient to enable it to perform the Research and authorises
                                         Quotient and its Service Providers to use, modify and copy the same to the extent necessary
                                         to enable Quotient to carry out such Research.



 


		4.2	Quotient
                                         shall ensure that it uses Materials and Customer Data solely to carry out the Research.
                                         Title and risk of loss to Materials supplied by Customer shall remain with Customer while
                                         such items are in the possession of Quotient and during the services, and Quotient shall
                                         have no obligation to insure such Materials against any loss or damage.



 


		4.3	Quotient
                                         shall maintain accurate records of its use, storage; handling and administration of Materials
                                         and shall supply the Customer with copies thereof upon reasonable written request.



 


		4.4	As
                                         soon as is reasonably practicable following completion of the the Customer shall provide
                                         instructions to Quotient in writing to return to the Customer or dispose of at the Customer’s
                                         expense, any Materials which remain unused and any copies of Customer Data provided to
                                         it by the Customer under this Agreement in Quotient’s possession or control, save
                                         that Quotient may retain one copy for internal audit or regulatory processes.. If after
                                         sixty days Customer has not taken possession or provided instructions regarding such
                                         Materials, they will be considered abandoned and may be discarded according to Quotient’s
                                         established procedures. If needed, Customer will be billed for any fees associate with
                                         disposition of these materials, components or equipment at cost + 10%.



 


		4.5	The
                                         Customer warrants it has the right to give to Quotient all Materials and Customer Data
                                         which it provides to Quotient and that the use by Quotient and its Service Providers
                                         of such Materials and/or Customer Data will not the infringe the Intellectual Property
                                         or other rights of any person.



 



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		5.	Confidentiality



 


		5.1	Subject
                                         to Clauses 5.2 and 7.1, each Party warrants, represents and undertakes to keep confidential
                                         and not to disclose any Confidential Information of the other Party, except to its Affiliates
                                         and to those of its employees (and in the case of Quotient any Service Providers) who
                                         must have access to such confidential information to perform the obligations under this
                                         Agreement and/or any Work Order and who have been informed of the confidential nature
                                         of such information. The obligations set out in Clause 5.1 shall not apply to
                                         any Confidential Information which:



 










		(a)	at
                                         the date of its disclosure is in the public domain or which enters the public domain
                                         through no act or omission by the receiving Party;



 


		(b)	at
                                         the date of its disclosure is already known to the receiving Party;



 


		(c)	is
                                         independently developed by the receiving Party or is lawfully disclosed to the receiving
                                         Party by a third party; or



 


		(d)	must
                                         be disclosed by the receiving Party to comply with a legal obligation.



 


In
relation to any information created by (rather than disclosed to) one Party but which is, under this Agreement and/or any Work
Order, deemed to be the Confidential Information of the other Party on creation, any reference in Clauses 5.2 (a) to (b) above
to “disclosure” shall mean “creation” and to “receiving Party” shall mean “creating
Party”.


 


		5.2	All
                                         confidential information containing Personal Data will be handled in accordance with
                                         applicable law and the Data Privacy Addendum at the Appendix 3 of the Work Order.



 


		6.	Intellectual
                                         Property



 


		6.1	Subject
                                         to Clauses 6.3, 6.5 and 6.6 and subject to the payment in full by the Customer to Quotient
                                         of all sums due under this Agreement and/or any Work Order, Quotient shall assign to
                                         Customer all their right, title and interest in and to any Research Output and the Intellectual
                                         Property rights.



 


		6.2	At
                                         the request and expense of the Customer, Quotient shall do all such things and sign all
                                         documents or instruments reasonably necessary to vest in the Customer the rights in Research
                                         Output assigned under Clause 6.1.



 


		6.3	Save
                                         as set out in Clauses 6.4 and 6.5, nothing in this Agreement and/or any Work Order shall
                                         transfer or grant any right, title or interest to any Background Material and/or Background
                                         Intellectual Property of either Party to the other Party.



 


		6.4	The
                                         Customer grants to Quotient a royalty-free, non-exclusive licence to use the Customer’s
                                         Background Intellectual Property solely to the extent necessary for Quotient to perform
                                         its obligations set out in this Agreement and/or any Work Order.



 


		6.5	Quotient
                                         grants to the Customer a royalty-free, non-exclusive licence to use Quotient’s
                                         Background Intellectual Property solely to the extent necessary for the Customer to use
                                         and/or develop any Research Output without restriction. Quotient shall own any improvements
                                         to its Background Intellectual Property arising and/or developed by it in the performance
                                         of this Agreement and/or any Work Order and shall be entitled to use and exploit as it
                                         deems fit any skills, techniques, concepts or know-how acquired, developed or used while
                                         performing any Research.







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		7.	Publication



 


		7.1	Quotient
                                         may publish the results of any Research, subject to the Customer’s prior written
                                         consent, which shall not be unreasonably withheld or delayed. Following the receipt of
                                         such consent, Quotient shall submit a copy of the proposed publication to the Customer
                                         who shall have 30 days in which to request amendments which, if such proposed amendments
                                         are reasonable, Quotient shall have to incorporate before such publication. Customer
                                         may require Quotient to remove information or data which may impair Customer’s
                                         ability to obtain patent protection or may be reasonably assumed to be a trade secret.
                                         In such circumstances, Quotient Sciences agrees to delay the proposed publication for
                                         an additional sixty (60) days to enable Customer to seek patent protection.



 


		7.2	The
                                         Customer undertakes that, before publication of any information, article, paper, report
                                         or other material about any Research, it will submit a copy of such publication to Quotient
                                         who shall have 30 days in which to request amendments thereto which, if such proposed
                                         amendment are reasonable, the Customer shall have to incorporate before such publication.



 


		8.	Delays



 


		8.1	If
                                         any part of any Research is delayed at the request of the Customer or due to the act
                                         or omission of the Customer or due to any delay in approving the Research by any regulator,
                                         ethics committee or similar body, then the Customer shall pay to Quotient any losses
                                         and increased costs and expenses including any Non-Cancellable Costs.



 


		8.2	Quotient
                                         shall use its reasonable endeavours to mitigate the losses, costs and expenses referred
                                         to in Clause 8.1.



 


		9.	Duration
                                         and Termination



 


		9.1	This
                                         Agreement shall come into force on the Commencement Date and shall, unless terminated
                                         earlier under the provisions of this Clause 9 (and subject to Clause 9.9) below, remain
                                         in force for the Term or until the Customer has received the final Research Output to
                                         be delivered by Quotient, and Quotient has received all sums payable to it, under this
                                         Agreement and all Work Orders. To avoid doubt, each Work Order shall come into force
                                         on the date it has been signed by both Parties and shall (subject to earlier termination
                                         under this Section 9 and to the provisions of Clause 9.9) remain in force until the Customer
                                         has received the Research Output to be delivered by Quotient, and Quotient has received
                                         all sums payable to it, under that Work Order.



 


		9.2	Either
                                         Party may terminate this Agreement, and/or any Work Order (and the relevant Research),
                                         forthwith by giving thirty (30) days’ notice in writing to the other Party if the
                                         other Party, (being a company) enters into liquidation or a provisional liquidator is
                                         appointed regarding it, shall pass a resolution or suffer an order of a court to be made
                                         for its winding up, or if a receiver, administrator, administrative receiver or manager
                                         or similar officer is appointed regarding the whole or any part of its assets, or if
                                         a notice of intention to appoint an administrator or an application to appoint an administrator
                                         shall be presented or filed regarding it, or (being an individual or partnership) the
                                         other shall suspend payment or propose to enter into any composition with creditors or
                                         become unable to pay its debts (or have no reasonable prospect of doing so) or suffer
                                         a bankruptcy order or if anything analogous or similar to the above occurs to the other
                                         in any jurisdiction.







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		9.3	Either
                                         Party may terminate a specific Work Order (and the Research), forthwith by giving notice
                                         in writing to the other party, if such party is in material breach of that Work Order
                                         and (where the breach is capable of remedy) fails to remedy the same within thirty (30)
                                         days of a request specifying the breach and requiring it to be remedied.



 


		9.4	Subject
                                         to Clause 9.5, the Customer may terminate this Agreement or any Work Order (and the Research)
                                         on giving Quotient not less than thirty (30) days’ notice in writing.



 


		9.5	On
                                         termination of any Work Order (whether by termination of the Agreement or by termination
                                         of that Work Order) the Customer shall pay to Quotient (in full without set off or deduction
                                         of any kind) any:



 


		(a)	amounts
                                         which Quotient has invoiced to the Customer but which remain unpaid at the date of termination
                                         and/or which Quotient may invoice under the Payment Schedule; and



 


		(b)	reimburse
                                         and/or pay (as appropriate) to Quotient all losses, liabilities, Non-Cancellable Costs,
                                         third-party costs and expenses (always including the cost of labour and/or materials
                                         as set out in the Proposal):



 


		(i)	incurred
                                         by Quotient because of such termination;



 


		(ii)	which
                                         have been incurred regarding the Research at the date of termination but not yet invoiced;
                                         and/or



 


		(iii)	which
                                         Quotient has not yet incurred but will incur in the future regarding the Research; and



 


provided
that any payment made under this Clause 9.6 shall not exceed the total amount set out in the Proposal


 


		9.6	Quotient
                                         shall use its reasonable endeavours to mitigate the losses, costs and expenses
                                         referred to in Clause 9.5(b).



 


		9.7	Termination
                                         of this Agreement and/or any Work Order shall be without prejudice to all rights and
                                         remedies which have accrued before such termination. Any provision of this Agreement
                                         and/or any Work Order which expressly or by implication should survive (including, without
                                         limitation, Clauses 1, 2.3, 2.7, 2.9, 2.11, 3.1, 3.35.1, 6.5, 8.1, 9.5, 9.8, 10.1, 10.2
                                         and Sections 11, 12, 14 and 15) shall survive the expiry or sooner termination of this
                                         Agreement or that Work Order (as applicable). To avoid doubt, if this Agreement terminates,
                                         each Work Order shall terminate, it being understood and agreed that termination or expiry
                                         of one Work Order shall not of itself affect the continuation of another Work Order or
                                         (subject to Clause 8.1 above) this Agreement.







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		10.	Indemnity



 


		10.1	The
                                         Customer as Sponsor confirms that it accepts its obligations to compensate Trial Subjects
                                         in line with the Regulations and the ABPI Guidelines for Phase 1 Clinical Trials published
                                         in 2018 and any guidelines referenced, including but not limited to the Guidance for
                                         Insurance and Compensation in the event of injury in Phase I clinical trials and the
                                         Clinical Trial Compensation Guidelines issued in November 2014, and any further amendments
                                         to these Guidelines as appropriate.



 


		10.2	The
                                         Customer shall indemnify and keep indemnified Quotient and shall pay such sums to Quotient
                                         as would keep Quotient’s employees and Service Providers indemnified, from and
                                         against any and all losses, costs, expenses (including legal expenses), claims, damages
                                         and liabilities (collectively “Losses”) arising out of or in connection with
                                         any claim made by a third party which arises out of the performance of the Research and/or
                                         administration to, and/or consumption by, any person of any Materials during any Research
                                         provided that the Customer shall not be liable under this Clause 10.2 for any Losses
                                         to the extent that these are directly caused by the failure of Quotient or of any Service
                                         Provider to comply with the Clinical Protocol for the Research or to observe Good Clinical
                                         Practice.



 


		10.3	The
                                         Customer shall indemnify and keep indemnified Quotient against all Losses arising out
                                         of a breach by the Customer of any laws or Regulations in relation to any Research and/or
                                         the Materials including its obligations as Sponsor of any Research under the Regulations.



 


		10.4	The
                                         Customer shall indemnify and keep indemnified Quotient in respect of any Losses incurred
                                         by Quotient and/or any Service Provider due to any third party allegation or claim that
                                         any such use referred to at Section 4 infringes the Intellectual Property of any third
                                         party.



 


		10.5	Subject
                                         to Clause 12, Quotient shall indemnify and keep indemnified the Customer against all
                                         Losses arising out of any claim made by a third party which arises out of the administration
                                         to a Trial Subject of any Materials during the course of Research to the extent that
                                         this is directly due to Quotient’s failure to comply with the Clinical Protocol
                                         for the Research or to observe Good Clinical Practice in administering the Materials
                                         as part of that Research.



 


		10.6	If
                                         either Party receives written notice of any third party claim which may cause a right
                                         to indemnification from the other Party, the Party seeking indemnification (the “Indemnified
                                         Party”) shall give written notice thereof to the other Party (the “Indemnifying
                                         Party”) setting forth the nature and amount of the claim and the basis of the claim
                                         for indemnification. The Indemnifying Party, and/or its insurers, may, upon written notice
                                         to the Indemnified Party within thirty (30) days of its receipt of the claim for indemnification,
                                         subject to the Indemnified Party providing such security as to costs and damages as may
                                         reasonably be required, elect to assume defence of the claim; provided, however, that
                                         the Indemnifying Party may not, in defence of such claim, consent to the entry of any
                                         judgment or enter into any settlement without the consent of the Indemnified Party which
                                         does not include, as an unconditional term thereof, a full release of the Indemnified
                                         Party in respect thereof. If the Indemnifying Party elects to assume the defence of the
                                         third party claim, the Indemnified Party may retain legal counsel at its own expense
                                         to participate in the defence; provided, however, that the Indemnifying Party shall be
                                         liable to the Indemnified Party for any legal or other expenses incurred by the Indemnified
                                         Party in connection with its subsequent assumption of the defence at the request of the
                                         Indemnifying Party. If the Indemnifying Party does not elect to assume control of the
                                         defence, the Indemnified Party will allow the Indemnifying Party to participate in such
                                         defence, at the Indemnifying Party’s own cost and expense, and will not settle
                                         or otherwise dispose of the claim without the consent of the Indemnifying Party, which
                                         such consent shall not be withheld unreasonably.







    11


     


    




		11.	Insurance



 


		11.1	Each
                                         party shall secure and maintain in full force and effect throughout the term of this
                                         Agreement appropriate insurance coverage for its responsibilities in connection with
                                         this Agreement.



 


		11.2	Where
                                         applicable the Customer shall maintain in force a no fault clinical trials insurance
                                         coverage policy with a reputable insurer to provide coverage to Trial Subjects sustaining
                                         bodily injury as a result of their participation in the Research and the use of the Materials.
                                         Such cover shall provide for a minimum cover of GBP five million (£5,000,000).
                                         Customer will provide indemnity to Quotient in this regard and in accordance with Section
                                         10, Indemnity and upon Quotient’s request shall provide for Quotient’s and/or
                                         Ethics Committee review, policy documents, certificates and any other relevant documents,
                                         as required, evidencing such insurance.



 


		12.	Limitation
                                         of Liability



 


		12.1	Nothing
                                         in this Agreement or any Work Order shall exclude or restrict either Party’s liability
                                         for death or personal injury caused by that Party’s negligence, for fraudulent
                                         misrepresentation, or to the extent that any restriction or exclusion of liability is
                                         prohibited by law.



 


		12.2	Subject
                                         to Clause 12.1, in no event shall Quotient be liable in contract (including under any
                                         indemnity), tort (including negligence), breach of statutory duty or otherwise howsoever
                                         for;



 


		(a)	any
                                         loss of profit, loss of business, loss of goodwill, loss of contracts, loss of revenues
                                         or loss of anticipated savings;



 


		(b)	any
                                         increased costs or expenses; or



 


		(c)	any
                                         special, indirect, or consequential loss or damage of any nature, whatever the cause
                                         thereof



 


in
each case arising out of or in connection with this Agreement or any Work Order.






    12


     


    




		12.3	Subject
                                         to Clause 12.1, the entire liability of Quotient to the Customer arising out of or in
                                         connection with a relevant Work Order, whether arising from contract (including under
                                         any indemnity), tort (including negligence), or otherwise, shall not exceed the amount
                                         stipulated in the Proposal for that Work Order as to be paid by the Customer to Quotient.



 


		12.4	The
                                         Customer accepts that Quotient cannot act other than in accordance with the terms of
                                         any authorisation issued by a regulatory authority for any Research and in accordance
                                         with the Regulations and all other relevant legal duties and obligations. Accordingly
                                         Quotient is not responsible for, and shall have no liability to the Customer for, any
                                         delay, damage, liability or loss of or to the Customer (whether arising in contract,
                                         tort (including negligence) or otherwise) arising from the actions or failure to act
                                         of any regulatory authority or Ethics Committee or because of Quotient complying with
                                         its obligations under the Regulations or other legal duty or obligation including any
                                         obligation to provide notice or information to others regarding any Research and/or any
                                         obligation to safeguard the health and safety of any of its employees, Trial Subject
                                         or any other person who may be affected by any such trial.



 


		13.	Debarment



 


		13.1	Quotient
                                         certifies that it nor any of its employees have not been debarred, and have not been
                                         convicted of a crime which could lead to debarment of its provision of services under
                                         this Agreement in any relevant jurisdiction in accordance with the Regulations.



 


		13.2	If
                                         Quotient or any Quotient employee becomes debarred or receives notice of action or threat
                                         of action regarding its debarment, Quotient shall notify Customer immediately.



 


		13.3	Quotient
                                         certifies that it has not utilised, and shall not use the services of any individual
                                         in the performance of services under this Agreement or any Work Order that has been debarred
                                         or that has been convicted of a crime which could lead to debarment in any relevant jurisdiction
                                         in accordance with the Regulations.



 


		14.	Interpretation



 


		14.1	Any
                                         references in this Agreement to Clauses or Schedules are to Clauses of, or Schedules
                                         to, this Agreement, and references in a Schedule or part of a Schedule to a paragraph
                                         are to paragraphs of that Schedule or part of that Schedule. The Schedules shall have
                                         effect as part of this Agreement.



 


		14.2	Headings
                                         shall be ignored in construing this Agreement and/or any Work Order.



 


		14.3	References
                                         to a statute or statutory provision includes that provision as from time to time modified
                                         or re-enacted or consolidated whether before or after this Agreement and any statutory
                                         instrument, order, by-law or other provision that may have been or may be made under
                                         it from time to time.



 



    13


     


    




		14.4	In
                                         the case of conflict or ambiguity, the order of precedence for this Agreement and the
                                         documents attached to or referred to in this Agreement shall be:



 










		(a)	the
                                         Clinical Protocol



 


		(b)	the
                                         Clauses of these terms; and



 


		(c)	the
                                         Schedules to this Agreement;



 


provided
that, if any conflict occurs or inconsistency between a term of this Agreement and a term of a Work Order, the term of the Work
Order shall (to interpret that Work Order) prevail.


 


		14.5	All
                                         references to time in this Agreement and/or any Work Order are to UK time. A reference
                                         to “Business Days” are to any day other than a Saturday, Sunday or public
                                         holiday in England.



 


		14.6	Unless
                                         the context otherwise requires, any reference in this Agreement or a Work Order to a
                                         “Party” shall be to one party thereto (and reference to “Parties”
                                         shall be construed accordingly).



 


		15.	General



 


		15.1	Each
                                         Party warrants it shall not directly or indirectly pay or promise to pay, or authorise
                                         the payment of any money, or give, promise to give or authorise giving anything of value
                                         on behalf of the other Party to any person or entity, including any government official,
                                         political party, healthcare professional or person affiliated with a healthcare organisation,
                                         for (a) obtaining or retaining business or securing an improper advantage, or (b) influencing
                                         their acts or decisions, or (c) influencing such person or political party to use its
                                         influence with a government or any of its instrumentality, or iv) for any other purpose
                                         prohibited by public policies and any applicable anti-bribery laws, including the UK
                                         Bribery Act 2010 and industry and all other applicable professionals codes governing
                                         anti-bribery and anti-kickback practices.



 


		15.2	Quotient
                                         will upon written notice to the Customer, and with Customer agreement, be entitled to
                                         sub-contract all or any of its obligations and to assign and/or novate all or any of
                                         its rights and/or obligations under this Agreement and/or any Work Order to any person.



 


		15.3	The
                                         Customer shall not, without the prior written agreement of Quotient, assign, novate,
                                         transfer sub-contract or otherwise dispose of the Customer’s rights or obligations
                                         arising under this Agreement and/or any Work Order.



 


		15.4	Neither
                                         Party shall be liable for any failure to perform, or delay in performing, any of its
                                         obligations (other than payment and indemnity obligations) if and to the extent that
                                         the failure or delay is caused by Force Majeure and the time for performance of the obligation,
                                         the performance of which is affected by Force Majeure, shall be extended accordingly.



 


		15.5	This
                                         Agreement (with all other documents to be entered into under it) sets out the entire
                                         agreement and understanding between the Parties in connection with the subject thereof,
                                         and supersedes all proposals and prior agreements, arrangements and understandings between
                                         the Parties.







    14


     


    




		15.6	Each
                                         Party acknowledges that in entering into this Agreement and/or any Work Order (and any
                                         other document to be entered into under it) it does not rely on any representation, warranty,
                                         collateral contract or other assurance of any person (whether Party to this Agreement
                                         or otherwise) that is not set out in this Agreement or that Work Order (as applicable)
                                         or any document referred to in it. Each Party waives all rights and remedies which, but
                                         for this Clause, might otherwise be available to it in respect of any such representation,
                                         warranty, collateral contract or other assurance. The only remedy available to any Party
                                         in respect of any representation, warranty, collateral contract or other assurance set
                                         out in this Agreement or a Work Order (or any document referred to in it) is for breach
                                         of contract under this Agreement or that Work Order (or the relevant document) as applicable.



 


		15.7	Except
                                         as expressly stated in this Agreement (or a Work Order, in which case such exception
                                         will only apply for that Work Order) all conditions, warranties, stipulations and other
                                         statements whatsoever (except as to title to goods) that would otherwise be implied or
                                         imposed by statute, at common law, by a course of dealing or otherwise howsoever are
                                         excluded to the fullest extent permitted by law.



 


		15.8	No
                                         variation of this Agreement or any Work Order shall be effective unless it is in writing
                                         and is signed by or on behalf of each of the Parties.



 


		15.9	The
                                         rights and remedies of the Parties in connection with this Agreement and any Work Order
                                         are cumulative and, except as expressly stated in this Agreement or that Work Order as
                                         applicable, are without prejudice to and are not exclusive of any other rights or remedies
                                         provided by law or equity or otherwise. Except as expressly stated in this Agreement
                                         or any Work Order any right or remedy may be exercised (wholly or partially) from time
                                         to time.



 


		15.10	Unless
                                         expressly stated elsewhere in this Agreement (or a Work Order), all notices to be given
                                         to a Party under this Agreement (or that Work Order, as applicable) shall be in writing
                                         in English and shall be marked for the attention of the person, and delivered by hand
                                         or sent by first class prepaid post to the address detailed at the first page. A notice
                                         shall be treated as having been received:



 


		(a)	if
                                         delivered by hand between 9.00 am and 5.00 pm on a Business Day (which time period is
                                         referred to in this Clause 13 as “Business Hours”), when so delivered; and
                                         if delivered by hand outside Business Hours, at the next start of Business Hours;



 


		(b)	if
                                         sent by first class post, at 9.00 am on the fifth Business Day after posting if posted
                                         on a Business Day and at 9.00 am on the seventh Business Day after posting in any other
                                         case; and



 


in
proving that a notice has been given it shall be sufficient to prove that delivery was made, or that the envelope containing the
notice was properly addressed and posted.


 







E-mailed
notices are not valid for this Agreement and/or any Work Order but this does not invalidate any other lawful mode of service.






    15


     


    




		15.11	The
                                         Parties intend each provision of this Agreement and each Work Order to be severable and
                                         distinct from the others. If a provision of this Agreement or a Work Order is held to
                                         be illegal, invalid or unenforceable, in whole or in part, the Parties intend that the
                                         legality, validity and enforceability of the remainder of this Agreement or Work Order
                                         (as relevant) shall not be affected.



 


		15.12	Any
                                         person who is not a Party to this Agreement (or a Work Order) cannot enforce any term
                                         of this Agreement (or that Work Order, as applicable) under the Contracts (Rights of
                                         Third Parties) Act 1999, but this does not affect any right or remedy of a third party
                                         which exists or is available apart from that Act.



 


		15.13	This
                                         Agreement may be entered into in several counterparts and by the Parties on separate
                                         counterparts, which taken together shall constitute the same instrument. However, this
                                         Agreement shall not come into force until each of the Customer and Quotient have signed
                                         at least one counterpart.



 


		15.14	The
                                         validity, construction and performance of this Agreement and any Work Order shall be
                                         governed by and construed in accordance with the laws of the state of Delaware. Each
                                         Party irrevocably agrees to submit to the exclusive jurisdiction of the courts of the
                                         state of Delaware over any claim, dispute or matter arising under or in connection with
                                         this Agreement or a Work Order.



 


		15.15	In
                                         relation to all matters arising out of or in connection with this Agreement or a Work
                                         Order, each of the Parties waives any objections on the grounds of venue or forum non
                                         conveniens or any similar ground and consents to service of process by mail or in
                                         any other manner permitted by the relevant law.



 


Signed
by the Parties or their duly authorized representative on the date of this Agreement.


 


	Signed
    by

    duly authorised for and on behalf of 

Quotient Sciences Limited	)

    )

    )	/s/
    Michael Astle
			 
	Signed
    by

    duly authorized for an on behalf of 

XORTX Therapeutics Inc.	)

    )

    )	/s/
    Allen Davidoff




    16


     


    

Schedule
1



WORK ORDER

(NUMBER [•])


 


Quotient
Reference: QSC[XXXXXX]

Sponsor reference: [e.g. protocol number, study number, molecule name & v. brief description of


service (e.g. Ibuprofen CMC,
AZD4635 ADME, etc.)


 


This
Agreement is made on [date]


 


This
Work Order is entered into between [Insert same details for Customer as used at the start of the main Agreement] (“Customer”)
and Quotient Sciences Limited whose registered office is at Trent House, Mere Way, Ruddington, Nottingham, NG11 6JS, United Kingdom
(“Quotient”) and is supplemental, and entered pursuant, to the Master Services Agreement dated [•] between
the Customer and Quotient (“Agreement”).


 


The
Parties agree;


 


		1.	Work
Order



 


This
document and its appendices constitute a “Work Order” under the Agreement. The terms set out in the Agreement (including,
without limitation, Clause 10 of the Agreement) shall apply to this Work Order.


 


		2.	Services
and Payment of Fees and Expenses



 


		2.1	The
specific services to be provided by Quotient, and the amount(s) to be paid by the Customer to Quotient in return, under this Work
Order (with the related timescales, invoicing dates, and invoicing and payment details) are in the following appendices which
shall for all purposes form part of this Work Order:




 


Appendix
1    Proposal


 


Appendix
2    Payment Schedule


 


Appendix
3    Data Privacy Addendum


 


The
Research will be conducted at the Quotient facility at [•]


 


		2.2	[Quotient
                                         will act as the Legal Representative of the Customer for the trial, study, and/or other
                                         services described in Appendix 1 to this Work Order]



 


		3.	Term



 


This
Work Order shall come into force on the date it has been signed by or on behalf of both Parties and shall remain in force in accordance
with Clause 8 of the Agreement.






    


     


    




		4.	Amendments



 


No
modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed and delivered by
each Party to the other.


 


		5.	Signatures



 


	Signed
                                         by

                                         duly authorised for and on behalf of 

Quotient Sciences Limited

        

        Date

        
	)

    )

    )	 
	 		 
	Signed
                                         by

                                         duly authorised for an on behalf of 

XORTX Therapeutics Inc.

        

        Date

        
	)

    )

    )	 




    


     


    

Appendix
1 (Work Order Number [◆]) 


 


Proposal


 


[◆][Insert
agreed proposal and costing document]


 


Amount
to be paid by the Customer: [◆]


 




    


     


    

Appendix
2 (Work Order Number [◆])


 


Payment
Schedule


 


	 	Payment
    Milestone — Invoicing Dates	Amount
	1	Signature
    of Work Order	40%
	2	First
    dosing day	30%
	3	Last
    Dosing Day	10%
	4	Database
    lock	10%
	5	Dispatch
    of draft report	5%
	6	Dispatch
    of final report*	5%


 


*or
4 weeks after dispatch of draft report, whichever is sooner.


 


The
non-cancellable recruitment and screening, clinic and manufacturing labour costs for the Research are:


 


	Study
    Period	Dates	Amount
	1	[◆]	£[◆]
	2	[◆]	£[◆]
	3	[◆]	£[◆]
	4	[◆]	£[◆]


 


Invoices
will be addressed to:


 


Name
[◆]





Address
[◆]





Phone
[◆]





Fax
[◆]





Email
[◆]


 


Payments
will be made by wire transfer to our ****** accounts:


 


******


 


Or
such other account and/or payment method as Quotient may notify to the Customer for that purpose from time to time.


 



    


     


    




Appendix
3 (Work Order Number [•])


 


Data
Privacy Addendum


 










This
agreement is made on [date]


 


This
Data Privacy Addendum is entered into between [Insert same details for Sponsor as used at the start of the main Agreement] (“Sponsor”)
and Quotient Sciences Limited whose registered office is at Trent House, Mere Way, Ruddington, Nottingham, NG11 6JS, United Kingdom
(“Quotient”) and is supplemental, and entered pursuant, to the [Services Agreement OR Work Order] dated [•] between
the Sponsor and Quotient (“Agreement”).


 


DEFINITIONS


 


Data
Controller: XORTX Pharma Corp.


 


Data
Processor: Quotient Sciences Limited 


 


Data
Protection Legislation: (i) unless the GDPR is no longer directly applicable in the UK, the General Data Protection Regulation
((EU) 2016/679) and any national implementing laws, regulations and secondary legislation, as amended or updated from time
to time, in the UK and then (ii) any successor legislation to the GDPR or the Data Protection Act 2018.


 


Protocol:
[INSERT SPONSOR AND QUOTIENT STUDY NUMBER]


 


		1.	DATA
PROTECTION



 


		1.1	Both
                                         parties will comply with all applicable requirements of the Data Protection Legislation.
                                         This clause 1.1 is in addition to, and does not relieve, remove or replace,
                                         a party’s obligations under the Data Protection Legislation.



 


		1.2	The
                                         parties acknowledge that for the Data Protection Legislation, the Sponsor is the data
                                         controller and Quotient is the data processor (where Data Controller and Data
                                         Processor have the meanings as defined in the Data Protection Legislation). Schedule
                                         One (1) sets out the scope, nature and purpose of processing by Quotient, the duration
                                         of the processing and the types of personal data (as defined in the Data Protection Legislation,
                                         Personal Data) and categories of Data Subject. Schedule Two (2) sets out the name,
                                         contact details and, where applicable, the Data Privacy Representative and/or Data Protection
                                         Officer of each party.



 


		1.3	Without
                                         prejudice to the generality of clause 1.1, the Sponsor will ensure that it has all necessary
                                         appropriate consents and notices in place to enable lawful transfer of the Personal Data
                                         to Quotient for the duration and purposes of this agreement.



 


		1.4	Without
                                         prejudice to the generality of clause 1.1, Quotient shall, in relation to any Personal
                                         Data processed in connection with the performance by Quotient of its obligations under
                                         this agreement:



 


		(a)	process
                                         that Personal Data only on the written instructions of the Sponsor unless Quotient is
                                         required by the laws of any member of the European Union or by the laws of the European
                                         Union applicable to Quotient to process Personal Data (Applicable Laws). Where
                                         Quotient is relying on laws of a member of the European Union or European Union law as
                                         the basis for processing Personal Data, Quotient shall promptly notify the Sponsor of
                                         this before performing the processing required by the Applicable Laws unless those Applicable
                                         Laws prohibit Quotient from so notifying the Sponsor;







    


     


    




		(b)	ensure
                                         that it has in place appropriate technical and organisational measures, reviewed and
                                         approved by the Sponsor, to protect against unauthorised or unlawful processing of Personal
                                         Data and against accidental loss or destruction of, or damage to, Personal Data, appropriate
                                         to the harm that might result from the unauthorised or unlawful processing or accidental
                                         loss, destruction or damage and the nature of the data to be protected, having regard
                                         to the state of technological development and the cost of implementing any measures (those
                                         measures may include, where appropriate, pseudonymising Personal Data, ensuring confidentiality,
                                         integrity, availability and resilience of its systems and services and regularly assessing
                                         and evaluating the effectiveness of the technical and organisational measures adopted
                                         by it);



 


		(c)	ensure
                                         that all personnel who have access to and/or process Personal Data must keep the Personal
                                         Data confidential; and



 


		(d)	not
                                         transfer any Personal Data outside of the European Economic Area unless the prior written
                                         consent of the Sponsor has been obtained and these conditions are fulfilled:



 


		(i)	the
                                         Sponsor or Quotient has provided appropriate safeguards in relation to the transfer;



 


		(ii)	the
                                         data subject has enforceable rights and effective legal remedies;



 


		(iii)	Quotient
                                         complies with its obligations under the Data Protection Legislation by providing an adequate
                                         level of protection to any Personal Data transferred; and



 


		(iv)	Quotient
                                         complies with reasonable instructions notified to it in advance by the Sponsor regarding
                                         the processing of the Personal Data;



 


		(e)	assist
                                         the Sponsor, at the Sponsor’s cost, in responding to any request from a Data Subject
                                         and in ensuring compliance with its obligations under the Data Protection Legislation
                                         regarding security, breach notifications, impact assessments and consultations with supervisory
                                         authorities or regulators;



 


		(f)	notify
                                         the Sponsor without undue delay on learning of a Personal Data breach;



 


		(g)	at
                                         the written direction of the Sponsor, delete or return Personal Data and copies thereof
                                         to the Sponsor on termination of the agreement unless required by Applicable Law to store
                                         the Personal Data; and







    


     


    




		(h)	maintain
                                         complete and accurate records and information to demonstrate its compliance with this
                                         clause one (1) and allow for audits by the Sponsor or the Sponsor’s designated
                                         auditor.



 


		1.5	The
                                         Sponsor consents to Quotient appointing third-party processors of Personal Data under
                                         this agreement. Quotient confirms that it has entered or (as the case may be) will enter
                                         with the third-party processor into a written agreement substantially on that third party’s
                                         standard terms of business. As between the Sponsor and Quotient, Quotient shall remain
                                         fully liable for all acts or omissions of any third-party processor appointed by it under
                                         this clause 1.5.



 


		1.6	Either
                                         party may, at any time on not less than 30 days’ notice, revise this Addendum by
                                         replacing it with any applicable controller to processor standard clauses or similar
                                         terms forming party of an applicable certification scheme (which shall apply when replaced
                                         by attachment to this agreement).



 


		1.7	If
                                         the Sponsor has nominated Quotient as a Data Privacy Representative in Schedule Two (2):



 


		1.7.1	Quotient
                                         will promptly relay to Sponsor any communications received in its capacity as Data Privacy
                                         Representative but accepts no further obligations as part of its role; and



 


		1.7.2	Sponsor
                                         shall indemnify, defend and hold harmless Quotient, and its respective employees, officers,
                                         directors, and agents, (each, an “Indemnified Party”) from and against all
                                         liabilities, damages, penalties, costs, expenses and fines resulting or arising from
                                         any claims, actions, demand or suits from a third party, a judicial, government, regulatory
                                         or law enforcement authority or any other authority (collectively “Losses”)
                                         that are incurred by or suffered by, made or instituted against an Indemnified Party,
                                         to the extent such Losses result from its capacity as, or performance of tasks related
                                         to, Data Privacy Representative of Sponsor, unless Quotient is in breach of its obligations
                                         at clause 1.7.1.



 


	Signed
                                         by

                                         duly authorised for and on behalf of 

Quotient Sciences Limited

        

        Date

        
	)

    )

    )	 
	 	 	 
	Signed
                                         by

                                         duly authorised for an on behalf of 

XORTX Pharma Corp.

        

        Date

        
	)

    )

    )	 




    


     


    

SCHEDULE
ONE


 


PROCESSING,
PERSONAL DATA AND DATA SUBJECTS


 


		1.	PROCESSING
                                         BY QUOTIENT



 


		1.1	SCOPE



 


Quotient
will process the Personal Data of Trial Subjects in accordance with, and to meet the aims of, the Protocol and the Agreement.


 


		1.2	NATURE



 


The
processing will involve analysis and presentation of the Trial Subjects’ Personal Data, including:


 


		●	[DELETE
                                         AS NECESSARY]






		●	statistical
                                         processes and reporting;






		●	review
                                         of PK data and associated calculations;






		●	comparisons
                                         with other Trial Subjects’ Personal Data;






		●	presentation
                                         of raw data relating to clinical procedures;






		●	transmission
                                         of samples and tracking information to selected subcontractors, who return data for analysis
                                         and reporting; and






		●	collation
                                         with other Trial Subjects’ Personal Data to produce summary findings.



 


Trial
Subjects’ Personal Data is pseudonymised at the earliest practical opportunity, resulting in the majority of the processing
being undertaken on pseudonymised Personal Data only.


 


The
processing will also involve use of employee’s Personal Data, including:


 


		●	as
                                         part of internal correspondence and correspondence between the parties;






		●	recording
                                         of employee’s actions and roles as part of the Protocol; and






		●	in
                                         the normal course of business to give effect to the agreement.



 


		1.3	PURPOSE
                                         OF PROCESSING



 


The
processing provides data to enable the Sponsor to assess the efficacy of the Sponsor’s drug product.


 


		1.4	DURATION
                                         OF THE PROCESSING



 


The
processing of Personal Data by Quotient is estimated to be a period of no longer than one year after the last visit of the Trial
Subject, which is [INSERT DATE OF LSLV PLUS 12 MONTHS], after which time no further processing is expected to be conducted.






    


     


    




Quotient
must retain copies of Personal Data in accordance with applicable industry law for monitoring, regulatory and audit purposes,
which could be for a period of up to 30 years or longer if prescribed by law.


 


		2.	TYPES
                                         OF PERSONAL DATA



 


Types
of Personal Data processed may include:


 


		●	[DELETE
                                         AS NECESSARY]






		●	Name






		●	Address






		●	Email
                                         address






		●	Age






		●	Trial
                                         subject number






		●	Volunteer
                                         number






		●	Passport
                                         number






		●	National
                                         insurance number



 


Types
of sensitive Personal Data processed may include:


 


		●	[DELETE
                                         AS NECESSARY]






		●	Health
                                         data, including medical records






		●	Racial
                                         or ethnic origin






		●	Genetic
                                         data






		●	Biometric
                                         data (e.g. photographs of the Data Subject)






		●	Data
                                         about a natural person’s sex life or sexual orientation



 


		3.	CATEGORIES
                                         OF DATA SUBJECT 



 


Categories
of Data Subject include:


 


		●	Clinical
                                         trial volunteers






		●	Employees
                                         of the Sponsor, Quotient or any sub-contractors.



 


		4.	TRANSFERS
                                         OF PERSONAL DATA OUTSIDE OF THE EUROPEAN ECONOMIC AREA (EEA)CONSENTED TO BY THE SPONSOR



 


These
transfers of Personal Data outside of the EEA have been consented to by the Sponsor:


 


[LIST
ANY TRANSFERS OF PERSONAL DATA OUTSIDE OF THE EEA OR SPECIFY ‘NONE]


 




    


     


    

SCHEDULE
TWO


 


Data
Controller


 


	Company
    Name	XORTX
    Therapeutics Inc.
	Contact
    Address	[*]
	Contact
    Telephone Number	[*]
	Contact
    Email Address	[*]
	Data
    Privacy Representative	[if
    applicable]
	Data
    Protection Officer	[if
    applicable]


[Note:
It is for the Data Controller to decide whether it needs a Data Protection Officer. If they don’t have one then please insert
‘none specified’.]


 


[


 


Data
Privacy Representative of Data Controller


 


	Company
    Name	 
	Contact
    Address	 
	Contact
    Telephone Number	 
	Contact
    Email Address	 
	Data
    Protection Officer	[if
    applicable]


]


 


[Note:
If the Data Controller is based outside of the EU it must nominate a Data Privacy Representative who can receive enquiries from
individuals and the regulator. Note: this can be Quotient if the Data Controller so desires.]


 


[Note:
It is for the Data Privacy Representative to decide whether it needs a Data Protection Officer, If they don’t have one then
please insert ‘none specified’.]






    


     


    




	 	Data
    Processor
	Company
    Name	Quotient
    Sciences Limited
	Contact
    Address	Trent
    House Mere Way, Ruddington Fields Business Park, Ruddington, Nottingham, NG11 6JS
	Contact
    Telephone Number	00
    44 115 974 9000
	Contact
    Email Address	dpo@quootientsciences.com
	Data
    Protection Officer	Michael
    Astle




    


     


    

[To
apply only where Quotient acts as the Legal Representative for the Customer— see Clause 2.9]


 


Schedule
2



The Medicines for Human use (Clinical Trials) Regulations 2004


 


		1	For
                                         the purposes of the Regulations, Quotient agrees that it shall act as Legal Representative
                                         for the Research throughout the duration of the Research besides the other services described
                                         in this Agreement and/or the Work Order provided that the Customer fulfils and continues
                                         to fulfil all its obligations to Quotient under this Agreement and the Work Order, including
                                         to avoid doubt the obligation to pay all monies due to Quotient under this Agreement
                                         and the Work Order.



 


		2	Quotient
                                         shall not provide any undertaking to any regulatory authority on behalf of Customer without
                                         the prior written consent of the Customer.



 


		3	For
                                         this Schedule 2 any word or phrase with a defined meaning in the Regulations shall be
                                         construed in this Schedule in accordance with the meanings ascribed in the Regulations.



 


		4	Quotient
                                         shall provide the Customer with a copy of all correspondence from the regulatory authority
                                         relating to the Research upon request from the Customer and will provide a copy of any
                                         authorisation and any notice received from the regulatory authority related to the Research
                                         within 2 Business Days of its receipt by Quotient.